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Federal Register / Vol. 83, No.

118 / Tuesday, June 19, 2018 / Rules and Regulations 28497

DEPARTMENT OF HOMELAND DEPARTMENT OF TRANSPORTATION whether to allow regulated entities to


SECURITY implement certain burden-reducing
49 CFR Part 11 provisions of the 2018 Requirements in
6 CFR Part 46 specified circumstances during such
Federal Policy for the Protection of
continued delay period.
DEPARTMENT OF AGRICULTURE Human Subjects: Six Month Delay of
the General Compliance Date of Through this final rule, we are
Revisions While Allowing the Use of adopting the proposals described in the
7 CFR Part 1c
Three Burden-Reducing Provisions April 20, 2018 NPRM. This rule delays
DEPARTMENT OF ENERGY During the Delay Period the general compliance date for the 2018
Requirements for an additional 6-month
10 CFR Part 745 AGENCY: Department of Homeland period, until January 21, 2019. As a
Security; Department of Agriculture; result of this delay, regulated entities
NATIONAL AERONAUTICS AND Department of Energy; National will be required, with an exception, to
SPACE ADMINISTRATION Aeronautics and Space Administration; continue to comply with the
Department of Commerce; Consumer requirements of the pre-2018 version of
14 CFR Part 1230 Product Safety Commission; Social the Federal Policy for the Protection of
Security Administration; Agency for Human Subjects (the ‘‘pre-2018
DEPARTMENT OF COMMERCE International Development; Department Requirements’’) until January 21, 2019.
of Housing and Urban Development; The one exception to this general rule
15 CFR Part 27 Department of Labor; Department of is that institutions will be permitted
Defense; Department of Education; (but not required) to implement, for
CONSUMER PRODUCT SAFETY Department of Veterans Affairs; certain research, three burden-reducing
COMMISSION Environmental Protection Agency; provisions of the 2018 Requirements
Department of Health and Human during the delay period (July 19, 2018,
16 CFR Part 1028 Services; National Science Foundation; through January 20, 2019). Those three
SOCIAL SECURITY ADMINISTRATION and Department of Transportation. provisions are: The revised definition of
ACTION: Final rule. ‘‘research,’’ which deems certain
20 CFR Part 431 activities not to be research covered by
SUMMARY: In a final rule published on
the Common Rule; the elimination of
AGENCY FOR INTERNATIONAL January 19, 2017, a number of federal
the requirement for annual continuing
DEVELOPMENT departments and agencies revised to the
review with respect to certain categories
Federal Policy for the Protection of
of research; and the elimination of the
22 CFR Part 225 Human Subjects (often referred to as the
requirement that institutional review
‘‘Common Rule’’), which each
boards (IRBs) review grant applications
DEPARTMENT OF HOUSING AND department and agency adopted into
or other funding proposals related to the
URBAN DEVELOPMENT regulations in its part of the Code of
research. Institutions taking advantage
Federal Regulations (CFR). The
Consumer Product Safety Commission of the three-burden reducing provisions
24 CFR Part 60
(CPSC) adopted the same changes in a must comply with all other pre-2018
DEPARTMENT OF LABOR final rule published on September 18, Requirements during the delay period.
2017. The revised Common Rule was The three burden-reducing provisions of
29 CFR Part 21 scheduled to become effective on the 2018 Requirements can only be
January 19, 2018, with a general implemented during the delay period
DEPARTMENT OF DEFENSE compliance date of the same date. By an with respect to studies initiated prior to
interim final rule issued on January 17, January 21, 2019 that will transition to
32 CFR Part 219 compliance with the revised Common
2018 and published in the Federal
Register on January 22, 2018, federal Rule. Any study that implements these
DEPARTMENT OF EDUCATION three burden-reducing provisions
departments and agencies delayed the
effective date and the general during the delay period must, beginning
34 CFR Part 97 on January 21, 2019, comply with all of
compliance date for the revised
DEPARTMENT OF VETERANS Common Rule for a 6-month period, the 2018 Requirements for the balance
AFFAIRS until July 19, 2018. The Department of of the study’s duration.
Housing and Urban Development (HUD) DATES: Effective date: This rule is
38 CFR Part 16 published an interim final rule adopting effective on July 19, 2018. Compliance
the same regulatory changes on January dates: The general compliance date for
ENVIRONMENTAL PROTECTION 26, 2018. The revised Common Rule, the 2018 Requirements in the final rule
AGENCY including technical amendments made published in the Federal Register (82
by the January 22, 2018 interim final FR 7149, Jan. 19, 2017) and of the final
40 CFR Part 26 rule, is referred to here as the ‘‘2018 rule published by the Consumer Product
Requirements.’’ Safety Commission in the Federal
DEPARTMENT OF HEALTH AND On April 20, 2018, the federal Register (82 FR 43459, Sept. 18, 2017),
HUMAN SERVICES departments and agencies listed here which were delayed in the interim final
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published a notice of proposed rule published in the Federal Register


45 CFR Part 46
rulemaking (NPRM) proposing and (83 FR 2885, Jan. 22, 2018), and adopted
seeking comments as to whether the by HUD through an interim final rule
RIN 0937–AA05
general compliance date for the 2018 published in the Federal Register (83
NATIONAL SCIENCE FOUNDATION Requirements should be delayed for an FR 3589, Jan. 26, 2018), with the
additional 6-month period. The NPRM exception of § lll.114(b), is further
45 CFR Part 690 also proposed and sought comments on delayed until January 21, 2019. The

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28498 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

compliance date for § lll.114(b) § lll.114(b), which remained Both sets of comments tended to
(cooperative research) remains January January 20, 2020. On January 26, 2018, endorse some type of delay beyond July
20, 2020. HUD published an interim final rule 19, 2018 in the general compliance date
ADDRESSES: Jerry Menikoff, M.D., J.D., adopting the interagency interim final for the 2018 Requirements. Comments
Office for Human Research Protections, rule. 83 FR 3589. on the interim final rule tended to
1101 Wootton Parkway, Suite 200, On April 20, 2018, federal suggest that institutions be permitted to
Rockville, MD 20852. departments and agencies published a voluntarily implement the 2018
FOR FURTHER INFORMATION CONTACT: Jerry notice of proposed rulemaking (NPRM) Requirements in their entirety at any
Menikoff, M.D., J.D., Office for Human soliciting comments on two proposals. time after July 19, 2018, while
Research Protections (OHRP), 83 FR 17595. The first proposed an comments on the NPRM indicated broad
Department of Health and Human additional 6-month delay for the general support for the narrower approach of
Services, 1101 Wootton Parkway, Suite compliance date for the 2018 permitting the voluntary use of three
200, Rockville, MD 20852; telephone: Requirements (from July 19, 2018 to burden-reducing provisions during the
240–453–6900 or 1–866–447–4777; January 21, 2019). The second proposed delay period.
facsimile: 301–402–2071; email a flexibility that would allow regulated B. Public Comments on the January 22,
Jerry.Menikoff@hhs.gov. entities to take advantage of three 2018 Interim Final Rule and Response
burden-reducing provisions of the 2018 to Comments
SUPPLEMENTARY INFORMATION:
Requirements during the delay period.
I. Background Both proposals are described more fully As well as soliciting comments on the
below, together with a discussion of the delay of the implementation of the 2018
On January 19, 2017, the Department Requirements, the interim final rule
of Health and Human Services (HHS) public comments submitted, and our
response to public comments. For the solicited comments on the following:
and other federal departments and
agencies published a final rule revising reasons provided below, this final rule —Whether or not the interim final rule
the Federal Policy for the Protection of adopts the proposals set forth in the should be considered regulatory or
Human Subjects (generally referred to as NPRM. de-regulatory.
—Whether or not our assumption that
‘‘the Common Rule’’). 82 FR 7149. The II. Public Comments and Response to 50 percent of regulated entities would
CPSC adopted the same regulatory Comments have gone forward using the new or
changes in a separate final rule
A. 2018 Interim Final Rule and 2018 expanded exemption categories, had
published on September 18, 2017. 82 FR
NPRM Public Comment Summary the implementation date of the 2018
43459. The revised Common Rule was
Requirements remained January 19,
originally scheduled to become effective Public comment was solicited on the
2018, was correct.
on January 19, 2018, with a general interim final rule between January 22,
compliance date of January 19, 2018 2018 and March 19, 2018. Public We received no comments on our
(with the exception of the revisions to comment was solicited on the NPRM to assumption that 50 percent of regulated
the cooperative research provision at delay the implementation of the 2018 entities would have gone forward using
§ lll.114(b), which has a compliance Requirements while permitting the use the new or expanded exemption
date of January 20, 2020). of three burden-reducing provisions of categories had the implementation date
Some representatives of the regulated the 2018 Requirements between April of the 2018 Requirements remained
community expressed concern regarding 20, 2018 and May 21, 2018. January 19, 2018. We received one
their ability to implement all of the 2018 comment addressing whether or not the
We received 62 public comments on
Requirements by the scheduled general interim final rule should be considered
the interim final rule. Of these, 36
compliance date.1 regulatory or de-regulatory. This
comments were related to the Common
On January 17, 2018, HHS and other comment indicated that the 2018
Rule. The remaining 26 comments were
federal departments and agencies placed Requirements should be considered de-
not related to the Common Rule in any
on display at the Office of the Federal regulatory, without commenting on the
way. We received 73 comments on the
Register an interim final rule delaying regulatory or de-regulatory status of the
NPRM. Five of these comments were not
the effective date and general interim final rule.
related to the Common Rule.
compliance date of the 2018 Of the 36 comments received on the
Several common themes emerged interim final rule related to the Common
Requirements to July 19, 2018. 83 FR from the public comments on the
2885 (published January 22, 2018). This Rule (and more specifically on delaying
interim final rule and the NPRM. These the effective and general compliance
rule did not impact the compliance date included:
for the cooperative research provision at dates of the 2018 Requirements to July
—The need for the regulated community 19, 2018), several themes were present.
1 See, e.g., the June 21, 2017 letter to Jerry to have as much advance notice as Many of these comments discussed
Menikoff from the Association of American Medical possible about any delay in issues with the timing and issuance of
Colleges, Association of American Universities, implementing the 2018 Requirements. the interim final rule, claiming that the
Association of Public & Land-grant Universities, —The need for guidance to be issued
and Council on Governmental Relations, available
fact that it was put on public display in
at https://www.aamc.org/download/480840/data/ promptly. the Federal Register 48 hours before the
aamcissuesjointletteroncommonrule.pdf. —General support for a delay of the original implementation date caused
See the June 9, 2017 letter to Secretary Thomas general compliance date, with more chaos and confusion in the regulated
Price from the American Medical Informatics limited support for a delay beyond community. Several commenters
Association at https://www.amia.org/sites/default/
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files/AMIA%20Letter%20Regarding%20the January, 2019. This support, however, described what they categorized as
%20Common%20Rule.pdf. was generally tied to concern with chaos that ensued when the interim
See also August 2, 2017 SACHRP Letter to HHS whether Common Rule departments final rule was put on public display 48
Secretary, Attachment A- Recommendations on and agencies will be able to issue hours before the original effective date
Compliance Dates and Transition Provisions,
https://www.hhs.gov/ohrp/sachrp-committee/
guidance in a timely fashion prior to and general compliance date for the
recommendations/attachment/a/august/2/2017/ the new general compliance date of 2018 Requirements. This rollout created
index.html. January 21, 2019. administrative burdens for institutions,

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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations 28499

as many had changed IT systems, the 2018 Requirements, in order to systems will need to be revised again to
training programs, and other operational provide institutions with the most comport with department and agency
tasks and then had to hastily undo these flexibility. A majority of the comments guidance.
changes. Another commenter described described in this paragraph advocated [Response: We agree with interim
the issuance of the interim final rule for delaying the general compliance date final rule comments suggesting that we
and the relative silence from Common to January 21, 2019, as these keep the effective date of the 2018
Rule departments and agencies in the commenters did not believe that full Requirements as July 19, 2018, while
period since publication of the 2018 compliance with the 2018 Requirements delaying the general compliance date.
Requirements (in the January 19, 2017 would be possible by July 19, 2018. A While we considered the alternative of
final rule) as a betrayal of IRBs. few commenters advocated delaying the amending the transition provision to
Additionally, commenters expressed general compliance date beyond January permit institutions to voluntarily
concern that given the short timeline 21, 2019 to permit institutions as much comply with the revised rule beginning
between the closing of the comment time as possible to comply with the on July 19, 2018, and not requiring
period and the new general 2018 Requirements compliance with the new rule until
implementation date of July 19, 2018, One commenter suggested that both January 21, 2019 or later, we believe this
any further delay of the 2018 the effective and general compliance approach could result in confusion
Requirements would similarly create dates be delayed by 6 months to one regarding implementation of the revised
chaos and confusion in the regulated year after Common Rule departments Common Rule that could be minimized
community. Commenters also generally and agencies issue critical guidance with the issuance of guidance from the
expressed that the 6-month delay documents. Other commenters Common Rule departments and
granted by the interim final rule created suggested that Common Rule agencies. By adopting the changes
a situation in which regulated entities departments and agencies should be proposed in the NPRM, we believe the
that were ready to implement the 2018 given a date by which they must publish Common Rule departments and
Requirements in January 2018 had to key guidance documents. Several agencies will be able to issue relevant
spend the personnel hours to ‘‘undo’’ comments included a description of guidance documents that will better
these changes, which seemed guidance documents that they would enable the regulated community to
contradictory to the overall goal of the like for Common Rule departments and comply with the 2018 Requirements. As
revisions to the Common Rule of agencies to focus on initially. described in the NPRM, we also
reducing administrative burden. A few Suggestions included: OHRP’s decision considered a delay to the effective and
commenters focused entirely on how charts, key information in informed general compliance dates without
the relative silence by Common Rule consent, broad consent, and continuing proposing this additional option in the
departments and agencies since review (§ lll.109(f)). interim period. Such an approach
publication of the 2018 Requirements Some of the comments relevant to the
would be simple to implement. We
has created a confusing environment for Common Rule advocated for no
decided against finalizing this
this regulated community and requested additional delay in the implementation
alternative to be responsive to public
more transparency from the regulating of the 2018 Requirements beyond July
comments received and in an effort to
departments and agencies in the future. 19, 2018. These comments argued that
minimize burdens with respect to new
[Response: We acknowledge that the institutions and Common Rule
provisions that will not be difficult to
timing of the interim final rule was not departments and agencies have had
implement prior to the general
ideal and led to frustration within the sufficient time to prepare for the
compliance date of the 2018
regulated community. We believe that implementation of the Rule. One
Requirements.
the 2018 NPRM and this final rule to comment suggested that while guidance
delay the general compliance date for would certainly be helpful, it is possible We recognize the difficulty in
the 2018 Requirements while permitting to implement the Rule without such implementing the 2018 Requirements in
the use of three burden-reducing guidance, as evidenced by the fact that the absence of guidance and will strive
provisions of the 2018 Requirements many institutions were ready to to issue guidance on key aspects of the
provides the regulated community with implement the 2018 Requirements 2018 Requirements as quickly as
sufficient notice about when the 2018 before the publication of the interim possible, while also engaging
Requirements will go into effect, and final rule. stakeholders.]
when regulated entities will be required Several commenters also addressed A small subset of comments suggested
to comply with the 2018 Requirements.] whether certain aspects of the 2018 additional revisions to the Common
Almost half of the comments related Requirements would be difficult to Rule. For example, one commenter
to the Common Rule advocated for the implement in the absence of agency discussed the inclusion of a provision
Common Rule departments and guidance. These commenters that would permit parents to decline
agencies to retain the July 19, 2018 acknowledged the importance of certain procedures on behalf of their
effective date for the 2018 guidance to implement many areas of children.
Requirements, and to delay the general the 2018 Requirements but noted that [Response: This comment listed
compliance date. These commenters the confusion and chaos created by late- several clinical procedures done in the
argued that during the period between breaking announcements of delays in routine course of medical care. Such
the effective date and delayed general the implementation of the 2018 activities are outside of the scope of the
compliance date, institutions should be Requirements ultimately caused more Common Rule, and thus are outside of
permitted to voluntarily comply (on a administrative burden within the scope of this rulemaking.]
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study-by-study basis) with the 2018 institutions. One large public university Others discussed concerns with the
Requirements. A couple of these system in the United States indicated waiver provision at § lll.101(i) and
comments advocated for institutions to that if guidance is issued after suggested that this provision be
be able to implement select 2018 institutions have revised their policies, strengthened such that departments and
Requirements during this voluntary procedures, and IT systems, it likely agencies are only permitted to waive the
compliance period, as opposed to will create a burdensome situation Common Rule with regard to certain
choosing to comply with the entirety of where policies, procedures, and IT research activities when such a waiver

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28500 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

is consistent with the Belmont Report.2 the transition provision is important for The NPRM also solicited comment on
One commenter also suggested that the institutions to manage their operations the advisability of two alternative
Clinton Memorandum3 concerning while implementing the 2018 approaches to delaying the 2018
requirements pertaining to classified Requirements. We do not believe that Requirements: (1) The alternative of
research be fully implemented. These this compromises the protection of delaying the effective date and general
comments also referenced concerns human subjects.] compliance date until January 21, 2019,
with the carve-out form the definition of A few comments suggested that the but without the option to implement
research pertaining to authorized general compliance date of the 2018 certain 2018 Requirements during that
operational activities in support of Requirements should coincide with delay period; and (2) the alternative of
national security missions. FDA’s revision of its human subjects delaying the effective date and general
[Response: The January 19, 2017 final protection regulations in order for there compliance date beyond January 21,
rule preamble stated ‘‘[t]hese authorized not to be a time period where FDA 2019. The NPRM also solicited
operational activities, as determined by regulations are not harmonized with the comment on whether the general
each agency, do not include research other Common Rule departments and compliance date for the 2018
activities as defined by the Common agencies. Requirements should remain July 19,
Rule, nor have they ever in the past [Response: With respect to the 2018.
been considered regulated by the comments suggesting that the general
The NPRM proposed to modify the
Common Rule. This category of activity compliance date of the 2018
transition provision at § lll.101(l) to
is removed from the definition of Requirements should be tied to the FDA
permit an institution or IRB (and not
research to make explicit that the harmonization efforts with the Common
just an IRB) to document the
requirements of the final rule do not Rule, we do not believe that this is
institution’s decision to transition a
apply to authorized operational necessary. FDA is currently working to
study to comply with the 2018
activities in support of national security harmonize its human subjects
Requirements. (We received no public
missions. This clarification is not regulations with the 2018 Requirements,
comments on this proposal.)
intended to narrow the scope of the to the extent permitted by FDA’s
statutory authority and mandate. We do A majority of comments that
Common Rule. We do not believe that discussed the NPRM proposals
this category contradicts President not believe it is necessary to further
delay the 2018 Requirements’ general supported some kind of delay to the
Clinton’s Memorandum of 1997 implementation of the 2018
regarding classified research, because compliance date as a result of a separate
rulemaking effort.] Requirements. A majority supported the
this category is merely clarifying what NPRM proposals as drafted but
activities are not considered to meet the One commenter argued that the 2018
Requirements should not be indicated that their support was
definition of research. The Clinton contingent upon the Common Rule
Memorandum calls for a number of implemented at all, as in their view, the
pre-2018 Requirements adequately departments and agencies issuing the
requirements to be added to protections relevant guidance prior to July 19, 2018
for classified research activities, but it protect human subjects.
[Response: We disagree. We believe for the three burden-reducing
does not address activities that are not provisions, and all other key guidance
considered research.’’] that the 2018 Requirements will provide
a meaningful improvement in human documents before the January 2019
Some commenters expressed concerns general compliance date. In particular,
with how the transition provision subjects protection, while reducing
administrative burden on institutions.] commenters noted that critical guidance
essentially creates a dual regulatory documents would need to be available
A couple of commenters argued that
system for human subjects protections. to the regulated community at least four
the general compliance date for the
One commenter explicitly advocated for
cooperative research provision (§ lll months prior to the proposed general
the Common Rule to require all research compliance date of January 21, 2019.
.114) should be delayed to 2022.
subject to the Common Rule to comply [Response: We disagree with the These commenters specifically stated
with the 2018 Requirements by a certain comments suggesting that the that if critical guidance documents were
date given the additional protections to compliance date for the cooperative not available by September 19, 2019,
subjects that the revised Common Rule research provision (§ lll.114(b)) they would support an additional delay
affords research participants. needs to be delayed beyond January of the general compliance date.
[Response: We agree that the 2020. Public comments requesting this
transition provision at § lll.101(l) Comments in response to the NPRM
change have not provided specific generally supported the position that
creates a system in which many evidence for why such a delay is
institutions will need to be familiar with many institutions need additional time
necessary, nor for the assertion that to prepare to implement the 2018
both versions of the Common Rule (if implementing the single IRB of record
they elect to keep at least some Requirements, and that the Common
in cooperative research requirement will Rule departments and agencies need
previously initiated studies subject to not result in a reduction in burden.]
the pre-2018 Requirements while their more time to develop and issue
newly initiated studies are subject to the C. Public Comments on the April 20, guidance. Several commenters
2018 Requirements). However, we 2018 NPRM and Response to Comments specifically noted that the Department
believe that the flexibility afforded by of Veterans Affairs is not yet ready to
The April 20, 2018 NPRM sought implement the 2018 Requirements and
comment on two primary proposals: (1) needs more time.
2 National Commission for the Protection of
The proposal to delay the general
Human Subjects of Biomedical and Behavioral Commenters suggested guidance
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Research. Ethical Principles and Guidelines for the compliance date for the 2018
Requirements to January 21, 2019; and documents that should be provided as
Protection of Human Subjects of Research. April 18,
1979. https://www.hhs.gov/ohrp/regulations-and- (2) whether institutions should be quickly as possible to the regulated
policy/belmont-report/. allowed to implement three burden- community. These suggestions included
3 Clinton, WJ. Strengthened Protections for
reducing provisions in the 2018 revising existing guidance, or issuing
Human Subjects of Classified Research. 62 FR new guidance, as follows:
26367–26372. May 13, 1997. https://www.gpo.gov/ Requirements during the delay period
fdsys/pkg/FR-1997-05-13/pdf/97-12699.pdf. from July 19, 2018 to January 21, 2019. —Revised OHRP decision charts

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—Information on the § lll.116 track of which studies have been We do not believe a delay of the
clinical trial consent form posting transitioned to the 2018 Requirements.] general compliance date beyond January
location Several alternatives were suggested 21, 2019 is necessary. As discussed in
—Limited IRB review for how a delay might be structured. the NPRM, we continue to believe that
—Broad consent These included: the regulated community will not need
—The new requirement that the —Permitting voluntary compliance with additional time beyond January 2019 to
informed consent give the prospective the entirety of the 2018 Requirements comply with the 2018 Requirements.
subject the information that a between July 19, 2018 and January 21, Most NPRM comments supported the
reasonable person would want to 2019 idea that January 2019 would be
know in order to make an informed —Keeping the NPRM proposals related sufficient to allow for implementation of
decision about research participation to decoupling the effective and the 2018 Requirements, provided that
—The new requirement that the general compliance dates and the the Common Rule departments and
informed consent begin with a early implementation of the three agencies issued key guidance.
concise and focused presentation of burden-reducing provisions of the We recognize that the implementation
the key information that is most likely 2018 Requirements, but delaying the structure in this final rule might be
to assist a prospective subject or effective date of the 2018 confusing to some in the regulated
legally authorized representative in Requirements until at least one year community. We intend to engage in
understanding the reasons why one after Common Rule departments and educational outreach to help the
might or might not want to participate agencies have issued key guidance regulated community better understand
in the research. documents what is permitted and what is not under
—Identifiability —Delaying both the effective and the revised transition provision at § ll
—Privacy and confidentiality general compliance dates until .101(l).]
—Benign behavioral interventions Several commenters indicated that
January 21, 2019
—Continuing review understanding OHRP’s plan for
—Delaying both the effective and
modifying the Federalwide Assurance
[Response: This final rule adopts the general compliance dates beyond
(‘‘FWA’’) process to comport with the
April 20, 2018 NPRM proposals, with January 21, 2019
2018 Requirements would also be
minor changes made to the regulatory —Permitting the use of the three
helpful. Specific concerns were raised
text for clarification and accuracy. As burden-reducing provisions of the
about the deletion of the option to
stated above, we agree with the 2018 Requirements, but not requiring
‘‘check the box’’ on the FWA and how
comments that the issuance of guidance that studies taking advantage of this
the removal of this option will, in
will be useful for institutions to be able flexibility comply with the entirety of
certain states with separate human
to implement the 2018 Requirements, the 2018 Requirements on and after
subjects requirements, present
and are working to issue such guidance January 21, 2019.
administrative challenges for
promptly. We appreciate the commenter A minority of comments indicated institutions. Another commenter
input on topics for guidance to be concern that the NPRM proposals would expressed concern about whether, after
issued by the departments and be confusing for the regulated January 21, 2019, FWAs would still be
agencies.] community to implement accurately. valid given that they would include
One commenter noted that if Common However, several of these comments statements and elections no longer
Rule departments and agencies indicated that if the Common Rule required under the 2018 Requirements.
envisioned a specific way that departments and agencies determined [Response: We intend to provide the
institutions or IRBs should document that moving forward with a delay was regulated community with information
the use of the three burden-reducing still appropriate, the structure proposed about how the FWA process will change
provisions in the 2018 Requirements or in the NPRM would be acceptable. well in advance of any modifications
document the fact that an ongoing study Regardless of the delay structure that are implemented. The 2018
has transitioned to comply with the endorsed, commenters noted that no Requirements at § lll.103(b) state
2018 Requirements, that information matter the delay option chosen by that the ‘‘[assurance] shall be filed in
must be communicated to the regulated Common Rule departments and such form and manner as the
community as soon as possible. agencies, guidance needed to be issued department or agency head prescribes.’’
[Response: We do not believe that in order for the regulated community to To that end, Common Rule departments
there is a need to prescribe how make use of the delay period and and agencies have significant flexibility
institutions document the decision to prepare their institutions. in what information is requested in the
use the three burden-reducing [Response: We acknowledge that there assurance process. Questions about non-
provisions of the 2018 Requirements or were multiple ways that an OHRP assurances will be addressed by
the decision to transition a study to implementation delay of the 2018 the relevant Common Rule departments
comply with the 2018 Requirements (on Requirements could be structured. We and agencies. With respect to OHRP
or after January 21, 2019), beyond the believe that the approach proposed in issued FWAs, OHRP wishes to make
requirement that the institution or an the NPRM and adopted in this final rule clear that assurances on file with the
IRB must document and date such is the best balance of permitting office will still be valid on and after
determination. For example, this institutions to implement several of the January 21, 2019 for their effective
institutional determination could be more straightforward provisions of the period. Additionally, any changes made
documented in IRB meeting minutes, or 2018 Requirements before the general to the assurance process will take
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in an IRB reviewer checklist (if an compliance date, while granting account of the fact that some
institution uses a checklist system). This Common Rule departments and institutions might oversee protocols that
institutional determination could also agencies additional time to develop and comply with the pre-2018 and 2018
be documented in an institution’s issue key guidance documents, and Requirements.]
existing electronic system, if one exists, granting institutions additional time to One commenter expressed concern
or in a spreadsheet created and ensure that their operations are ready to with how auditors would handle IRBs
maintained by the institution to keep implement the 2018 Requirements. reviewing protocols governed by both

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28502 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

the pre-2018 Requirements and the 2018 [Response: As explained in the April Requirements at any time before the
Requirements, given that the 2018 20, 2018 NPRM, we did not propose effective date.
Requirements do not require that every adding the revised exemption categories [Response: This commenter
nondiscriminatory effort will be made to to § lll.101(l)(4)(i)(A) because misunderstood the transition provision
ensure that no IRB consists entirely of implementation of these categories as written in the first publication of the
men or entirely of women (pre-2018 would involve significantly greater 2018 Requirements; the transition
Requirements at § lll.107(b)). complications. For example, we noted provision published in the January 19,
[Response: We believe that the § ll in the NPRM that these categories use 2017 final rule revising the Common
.107(a) requirements for diversity on terms that are newly defined, or for Rule did not include the ability for
IRBs serves the same purpose, and thus which revised definitions have been institutions to implement all provisions
do not see a conflict between the included in the 2018 Requirements, and of the 2018 Requirements before the
diversity requirements for IRBs under permitting compliance with these effective date and general compliance
the pre-2018 Requirements and the 2018 categories without also selectively date.]
Requirements.] adopting revised definitions could be As with the comments on the interim
While the NPRM did not solicit problematic. Specifically in regard to final rule, a few comments expressed
comments on the requirement for § lll.104(d)(4), this exemption concern with the waiver provision at
cooperative research to be reviewed by involves several regulations and statutes § lll.101(i) allowing federal
a single IRB (see § lll.114), we outside of the scope of the Common departments and agencies to waive
received several comments discussing Rule. As a result, it is a much more some or all provisions of the Common
this provision. Several asked for an complicated provision to implement, Rule (which could allow research to be
additional 2-year delay before the and thus was not included as one of the conducted on people without their
changes at § lll.114(b) become burden-reducing provisions of the 2018 informed consent). These comments
effective. Others said that this provision Requirements that institutions could additionally expressed concern with
should be amended such that use of a voluntarily implement during the delay institutions being permitted to
single IRB is voluntary in cooperative period. After consideration of the public implement the exclusion of certain
research. These comments argued that comments received, we continue to operational activities conducted by
the 2018 Requirements’ preamble believe that the approach proposed in intelligence agencies during the delay
(published in the January 19, 2017 final the NPRM makes the most sense.] period and suggested that this carve-out
rule) underestimated the costs of the One commenter argued that the 2018 from the definition of research be
single IRB mandate and the confusion Requirements should be withdrawn, removed from the 2018 Requirements.
that implementing this policy would and that Common Rule departments and [Response: We are not contemplating
create for investigators. Several of these agencies should issue several smaller modifying the carve-outs from the
comments acknowledged that over time, NPRMs to revise specific aspects of the definition of research. Regarding the
as institutions become accustomed to Common Rule. carve-out from the definition of research
developing reliance agreements and [Response: We disagree with this pertaining to authorized operational
managing the single IRB process, the comment. We believe that the 2018 activities in support of national security
costs currently being experienced would Requirements will provide a meaningful missions, the January 19, 2017 final rule
decrease. improvement in human subjects preamble noted that ‘‘[t]hese authorized
[Response: We appreciate the protection, while reducing operational activities, as determined by
comments received on the single IRB of administrative burden on institutions.] each agency, do not include research
record requirement in cooperative One commenter proposed that activities as defined by the Common
research (§ lll.114(b)). We continue institutions or other Common Rule Rule, nor have they ever in the past
to believe that a compliance date of departments and agencies be required to been considered regulated by the
January 20, 2020 for this provision gives file interim reports with HHS about Common Rule. This category of activity
institutions sufficient time to prepare their status with regard to full is removed from the definition of
and implement this requirement. While implementation and compliance with research to make explicit that the
these commenters anecdotally indicated the 2018 Requirements. This commenter requirements of the final rule do not
that implementing this requirement has suggested that HHS could issue waivers apply to authorized operational
been more costly to institutions than the for full implementation of the rule based activities in support of national security
January 19, 2017 final rule preamble on these interim reports. Additionally, missions. This clarification is not
estimated, no comment provided data such a reporting requirement would intended to narrow the scope of the
about the actual costs to implement this give HHS and other Common Rule Common Rule.’’]
provision. In the absence of specific departments and agencies the data
data, we retain our cost and benefit necessary to determine if another III. Delay of the General Compliance
assumptions related to this provision.] adjustment to the 2018 Requirements Date Until January 21, 2019
One comment suggested adding the might be needed. Through this final rule, the general
exemption category for secondary use [Response: We believe that this compliance date for the 2018
where consent is not required (§ lll approach is impractical and Requirements is delayed for a 6-month
.104(d)(4)) to the burden-reducing unnecessary. We believe that this final period until January 21, 2019. Section
provisions. This commenter noted that rule will give institutions sufficient time ll.101(l)(2) is revised to make this
because the inability to implement the to implement the 2018 Requirements, delay explicit. The dates included in the
revised exemptions during the delay which also precludes the need for such transition provision, set forth at § lll
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period (i.e., July 19, 2018 through a phased approach.] .101(l)(3), (4), and (5), are also modified
January 20, 2018) accounted for the One commenter indicated a desire to to reflect this revised general
majority of the costs estimated in the see a final rule containing the flexibility compliance date.
NPRM for this delay, it would be included in the original publication of As a result of this rule, regulated
preferable for the final rule to permit the the 2018 Requirements, on January 19, entities will be required to comply with
early implementation of this exemption 2017, that institutions be permitted to the pre-2018 Requirements prior to
category. implement provisions of the 2018 January 21, 2019 (putting aside the

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burden-reducing provisions discussed the same set of standards throughout of application or proposal) will apply
in section III below). Regulated entities their duration and will avoid a instead of § lll.103(f) of the pre-2018
may not, prior to January 21, 2019, circumstance in which such research is Requirements.
comply with all provisions of the 2018 subject to two sets of rules. However, as • Pursuant to § ll.101(l)(4)(i)(A)(3),
Requirements, with the exception of the described below, institutions may elect § lll.109(f)(1)(i) and (iii) of the 2018
three burden-reducing provisions, in to transition such studies to comply Requirements (exceptions to mandated
lieu of all provisions of the pre-2018 with the 2018 Requirements. continuing review) will apply instead of
Requirements. Of course, regulated § lll.103(b) of the pre-2018
entities are permitted to adopt B. Research Subject to the 2018 Requirements (as related to the
provisions that do not conflict with the Requirements (§ lll.101(l)(5)) requirement for continuing review) and
pre-2018 Requirements, prior to January Research initiated (i.e., initially in addition to § lll.109 of the pre-
21, 2019. For example, institutions may approved by an IRB, or for which IRB 2018 Requirements.
choose to incorporate additional review was waived by the government This approach is designed to afford
elements of informed consent that pursuant to § lll.101(i), or institutions additional time before they
happen to be found in the 2018 determined to be exempt) on or after are required to comply with all
Requirements, or elsewhere, so long as January 21, 2019 (the new general provisions of the 2018 Requirements,
such implementation does not conflict compliance date for the 2018 while enabling them to take advantage
with the pre-2018 Requirements. In Requirements) must be conducted in of the three burden-reducing provisions
other words, institutions have the same compliance with the 2018 during the delay period.
flexibility they have always had (i.e., to Requirements. In addition, beginning on January 21,
exceed the minimum requirements set 2019, such studies must, for the balance
C. Research That Transitions To Comply of their duration, comply with the 2018
by the regulations).
The compliance date for the With the 2018 Requirements on or After Requirements in their entirety.
cooperative research provision of the January 21, 2019 (§ lll.101(l)(4)(ii)) We believe this rule strikes an
2018 Requirements (§ lll.114(b)) Section ll.101(l)(4)(ii) applies to appropriate balance of permitting
remains January 20, 2020. studies following the pre-2018 voluntary early adoption of provisions
Requirements that transition to comply that reduce burdens without creating
IV. Optional Flexibility: significant complexities. An
with the 2018 Requirements on or after
Implementation of Certain Burden- institution’s decision about whether to
January 21, 2019. In such
Reducing Provisions During the Delay transition a study to the 2018
circumstances, the study must be
Period Requirements to take advantage of the
conducted in compliance with the 2018
As detailed in revised § lll Requirements beginning on the three burden-reducing provisions might
.101(l)(4) and as set forth below in more transition date (i.e., the date the vary depending on the nature and
detail, during the additional 6-month transition determination is documented, progress of the study, including any
period that the general compliance date on or after January 21, 2019) for its elements of the study to be conducted
for the 2018 Requirements is delayed duration. on or after January 21, 2019. For
(July 19, 2018 through January 20, example, studies planning to recruit
2019), institutions may transition a D. Research That Transitions To some subjects on or after January 21,
research study to the 2018 Requirements Comply With the 2018 Requirements 2019 would have to meet the new
in order to take advantage of three During the 6-Month Delay Period (§ ll requirements for obtaining the informed
burden-reducing provisions of the 2018 .101(l)(4)(i)) consent of those subjects. In contrast, for
Requirements. This final rule also As described in § lll studies in which the remaining
restructures § lll.101(l)(3) and (4) .101(l)(4)(i)(A), the option of applying activities consist only of completing
(now numbered (5)) to aid readability. A the three burden-reducing provisions of data analyses, the new requirements for
new section (now § lll.101(1)(4)) the 2018 Requirements during the 6- informed consent generally would not
describes how the requirements apply to month delay period is only available be applicable.
research transitioning to take advantage with respect to studies that transition to While the three burden-reducing
of the burden-reducing provisions comply with the 2018 Requirements provisions are a regulatory package, an
during different time periods. Below, we between July 19, 2018 through January institution that takes advantage of this
provide an overview of the revised 20, 2019. flexibility may, as a matter of
transition provision to clarify its Beginning on the date that the institutional policy, adopt a more
application to different types of studies, transition determination is documented, stringent standard (such as that of the
including studies taking early advantage through January 20, 2019, such studies pre-2018 Requirements) for any or all of
of the three burden-reducing provisions must comply with the pre-2018 the circumstances addressed by these
of the 2018 Requirements. Requirements, except that the studies three provisions. For example, if an
will comply with the three burden- institution chooses to adopt a policy
A. Research Subject to the pre-2018 that studies that qualify for expedited
reducing provisions instead of or in
Requirements (§ lll.101(l)(3)) review under a certain category should
addition to the comparable pre-2018
As a default, studies initiated (i.e., Requirements (specified in § lll continue to be subject to annual
initially approved by an IRB, or for .101(l)(4)(i)(A)(1)–(3)). continuing review, this rule does not
which IRB review was waived by the • Pursuant to § lll prevent the institution from adopting
government pursuant to § lll.101(i) .101(l)(4)(i)(A)(1), § lll.102(l) of the and implementing that policy.
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or determined to be exempt) before 2018 Requirements (definition of Given that studies taking advantage of
January 21, 2019 (the new general research) will apply instead of § lll this flexibility will be complying with
compliance date for the 2018 .102(d) of the pre-2018 Requirements). provisions from both the pre-2018
Requirements) will continue to be • Pursuant to § lll Requirements and the 2018
subject to the pre-2018 Requirements. .101(l)(4)(i)(A)(2), § lll.103(d) of the Requirements during the delay period,
This approach will maintain the ability 2018 Requirements (revised certification we explain how some provisions
of institutions to hold such studies to requirement that eliminates IRB review interact and clarify our intended

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28504 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

interpretations of particular regulatory Section ll.101(l)(4)(ii) applies to determination. Under the January 19,
provisions that will apply during the 6- studies following the pre-2018 2017 final rule, an institutional
month delay period. For studies electing Requirements that, at some point on or determination that research would
to transition to comply with the 2018 after January 21, 2019, transition to transition to comply with the 2018
Requirements during the 6-month delay comply with the 2018 Requirements. If Requirements had to be documented by
period (July 19, 2018 through January the determination to transition a study an IRB. Under this rule, such a
20, 2019), once the decision to to the 2018 Requirements is determination may be documented
transition the study is documented: documented on or after January 21, either by an IRB or an institution
1. In applying the definition of 2019, as of the date of documentation (through officials who have the
research under the 2018 Requirements the study must be conducted in authority to make such determinations
(§ lll.102(l)(3)), the reference to a compliance with the 2018 Requirements on behalf of the institution). Such
‘‘public health authority’’ will be given for its duration. documentation must include the date of
the meaning provided in the definition We clarify that the transition the transition determination, and
of ‘‘public health authority’’ in the 2018 provision at § lll.101(l)(4) of the records documenting the transition
Requirements (§ lll.102(k)). This 2018 Requirements extends to research decision must be retained in accordance
interpretation arises because ‘‘public newly initiated during the delay period. with § lll.115(b).
health authority’’ is defined in the 2018 Research newly initiated between July As a general matter, once an
Requirements, but not in the pre-2018 19, 2018 and January 20, 2019 may be institution decides to transition a study
Requirements. either conducted under the pre-2018 to the 2018 Requirements and that
2. In applying § lll.103(d) of the Requirements, in accordance with § ll determination is documented, the date
2018 Requirements, the reference to .101(l)(3); or, an institution may of documentation will serve as the de
research ‘‘exempted under § ll.104’’ transition research newly initiated facto compliance date for either the
will be interpreted to refer to research during the delay period to the 2018 three-burden reducing provisions for
exempted under § lll.101(b) of the Requirements, in accordance with § ll transition determinations documented
pre-2018 Requirements. This .101(l)(4), in which event the research between July 19, 2018 and January 20,
interpretation arises given that only the would be conducted under the pre-2018 2019, or the 2018 Requirements as
exemptions set forth in the pre-2018 Requirements, with substitution of the applied to the study for transition
Requirements will be in effect during three burden-reducing provisions of the determinations documented on or after
the 6-month delay period. 2018 Requirements for the comparable January 21, 2019.
3. The reference to ‘‘[r]esearch eligible provisions of the pre-2018 This final rule has an effective date of
for expedited review in accordance with Requirements. In addition, on or after July 19, 2018, to enable regulated
§ lll.110’’ in § lll.109(f)(1)(i) of January 21, 2019, an institution may entities to take advantage of the three
the 2018 Requirements will be choose to transition research initiated burden-reducing provisions during the
interpreted to refer to § lll.110 of the during the delay period that was delay period. However, as explained in
pre-2018 Requirements. initially conducted under the pre-2018 this rule, the requirements a study must
4. The documentation requirements Requirements, to compliance with the comply with beginning on July 19, 2018
described in § lll.115(a)(3) of the 2018 Requirements. In the NPRM, are detailed in the transition provision
2018 Requirements (documenting an proposed § lll.101(l)(4) referenced codified at § lll.101(l)(1)–(5).
IRB’s rationale for conducting application by an institution ‘‘engaged Finally, for consistency, headings were
continuing review not otherwise in research’’ to ‘‘ongoing’’ research. In added to § lll.101(l)(1) and (2).
required) are not applicable during this order to clarify the Common Rule V. Legal Authorities
period. departments’ and agencies’ intention
5. Sectionll.103(d) of the 2018 that research newly initiated during the The legal authorities for the
Requirements will be substituted for delay period may transition to the 2018 departments and agencies that are
§ lll.103(f) of the pre-2018 Requirements, this final rule no longer signatories to this action are as follows:
Requirements. Both sections address the includes the qualifier of ‘‘ongoing’’ to Department of Homeland Security, 5
requirement for certification of research describe research that transitions to the U.S.C. 301; Public Law 107–296, sec.
supported by a federal department or 2018 Requirements in accordance with 102, 306(c); Public Law 108–458, sec.
agency. In addition to removing the § lll.101(l)(4). The final rule at 8306. Department of Agriculture, 5
requirement that IRBs review grant § lll.101(l)(4) also includes the U.S.C. 301; 42 U.S.C. 300v–1(b).
applications or proposals, § lll additional wording ‘‘planning or’’ before Department of Energy, 5 U.S.C. 301; 42
.103(d) of the 2018 Requirements ‘‘engaged in research’’ to clarify that U.S.C. 7254; 42 U.S.C. 300v–1(b).
reflects other minor wording changes institutions are allowed to take National Aeronautics and Space
necessary to accommodate the removal advantage of the 2018 Requirements’ Administration, 5 U.S.C. 301; 42 U.S.C.
of the grant application or proposal carve-outs from the definition of 300v–1(b). Department of Commerce, 5
review requirement or to provide research for studies newly initiated U.S.C. 301; 42 U.S.C. 300v–1(b).
additional clarifications. during the delay period (which would Consumer Product Safety Commission,
allow a study that qualifies for one of 5 U.S.C. 301; 42 U.S.C. 300v–1(b).
E. General Transition Issues Social Security Administration, 5 U.S.C.
the carve-outs to be conducted without
The regulatory provisions are not prior IRB review and approval or 301; 42 U.S.C. 289(a). Agency for
prescriptive regarding how an application of the other regulatory International Development, 5 U.S.C.
institution chooses to make its requirements). 301; 42 U.S.C. 300v–1(b), unless
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transition decisions. An institution may This final rule revises the otherwise noted. Department of Housing
elect to transition research protocols to requirement, now set forth at § lll and Urban Development, 5 U.S.C. 301;
the 2018 Requirements on a protocol-by- .101(l)(4), regarding which entity may 42 U.S.C. 300v–1(b); 3535(d).
protocol basis, or for a class of protocols document an institution’s decision to Department of Labor, 5 U.S.C. 301; 29
(e.g., all minimal risk research), or for transition research. This change will U.S.C. 551. Department of Defense, 5
the institution’s entire research offer institutions greater flexibility U.S.C. 301. Department of Education, 5
portfolio. regarding who documents the transition U.S.C. 301; 20 U.S.C. 1221e–3, 3474.

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Department of Veterans Affairs, 5 U.S.C. 1. Need for This Final Rule and and some entities would experience
301; 38 U.S.C. 501, 7331, 7334; 42 Summary costs as a result of this rule.
U.S.C. 300v–1(b). Environmental —That 50 percent of regulated entities
Protection Agency, 5 U.S.C. 301; 7 On January 19, 2017, HHS and 15 will take advantage of the option to
U.S.C. 136a(a) and 136w(a)(1); 21 U.S.C. other federal departments and agencies implement three burden-reducing
346a(e)(1)(C); sec. 201, Public Law 109– published the 2018 Requirements provisions of the 2018 Requirements
54, 119 Stat. 531; and 42 U.S.C. 300v– designed to more thoroughly address early. Additionally, the NPRM sought
1(b). Department of Health and Human the broader types of research conducted comment that would provide insight
Services, 5 U.S.C. 301; 42 U.S.C. 289(a); or otherwise supported by all of the into entities’ views regarding the
42 U.S.C. 300v–1(b). National Science Common Rule departments and interconnectedness of the 2018
Foundation, 5 U.S.C. 301; 42 U.S.C. agencies. In addition, the CPSC adopted Requirements’ provisions and thus
300v–1(b). Department of the same regulatory changes on allow for refinement of the 50 percent
Transportation, 5 U.S.C. 301; 42 U.S.C. September 18, 2017. This rule was estimate.
300v–1(b). amended in a final rule published in the —That this rulemaking will not have
Federal Register on January 22, 2018 a significant economic impact on a
VI. Regulatory Impact Analyses and adopted by HUD through a final substantial number of small entities.
We have examined the effects of this rule published on January 26, 2018. We received several comments on the
final rule under Executive Order 12866 This final rule allows regulated costs and benefits associated with the
on Regulatory Planning and Review entities to continue to comply with the April 20, 2018 NPRM to delay the 2018
(September 30, 1993), Executive Order pre-2018 requirements until January 21, Requirements. None of these comments
13563 on Improving Regulation and 2019. As discussed above, this final rule provided specific feedback on the cost
Regulatory Review (January 18, 2011), also permits institutions, during the and benefit assumptions included in the
Executive Order 13771 on Reducing period between July 19, 2018 and NPRM.
Regulation and Controlling Regulatory January 21, 2019, to take advantage of These comments indicated that the
Costs (January 30, 2017), the Paperwork three provisions in the 2018 timing and implementation of the
Reduction Act of 1995 (Pub. L. 104–13), Requirements intended to minimize interim final rule created additional
the Regulatory Flexibility Act (Pub. L. burdens on regulated entities. Those administrative burden on institutions
96–354, September 19, 1980), the three burden-reducing 2018 that were prepared to implement the
Unfunded Mandates Reform Act of 1995 Requirements are (1) the 2018 2018 Requirements on January 19, 2018.
(Pub. L. 104–4), and Executive Order Requirements’ definition of ‘‘research,’’ As discussed above, one comment
13132 on Federalism (August 4, 1999). which deems certain activities not to be noted that if we permitted the
research, (2) the elimination of the exemption at § lll.104(d)(4) for
A. Executive Orders 12866, 13563, and secondary research where consent is not
13771 requirement for annual continuing
review of certain categories of research, required to be implemented prior to the
Executive Orders 12866 and 13563 and (3) the elimination of the general compliance date, this delay
direct agencies to assess all costs and requirement that IRBs review grant would essentially be cost neutral. While
benefits of available regulatory applications or proposals related to the we appreciate that there might be
alternatives and, if regulation is research. As described in section III economic benefits to permitting the
necessary, to select regulatory above, this flexibility is permitted for early implementation of one or more of
approaches that maximize net benefits studies for which an institution makes the new or revised exemption
(including potential economic, a choice to have those studies be subject categories, we did not include the
environmental, public health and safety to the 2018 Requirements. exemptions as one of the provisions of
effects; distributive impacts; and the 2018 Requirements institutions can
equity). Executive Order 13563 is 2. Public Comments on the April 20, utilize during the delay period finalized
supplemental to and reaffirms the 2018 NPRM RIA and Response to in this rule because of the added
principles, structures, and definitions Comments complexity of implementing the
governing regulatory review as exemptions in the absence of guidance.
The April 20, 2018 NPRM RIA
established in Executive Order 12866, Finally, we received several
solicited comment on the following
emphasizing the importance of comments indicating that the January
assumptions:
quantifying both costs and benefits, of 19, 2017 final rule preamble
reducing costs, of harmonizing rules, —That in almost all categories described underestimated the costs of
and of promoting flexibility. In in the RIA for the 2018 Requirements, implementing the cooperative research
accordance with the provisions of the foregone benefits (costs) of provision at § lll.114. These
Executive Order 12866, this rule was delaying the 2018 Requirements by comments argued that, at best, this
submitted to the Office of Management six months are what would have been provision would represent a shifting of
and Budget (OMB) for review and has the benefits of implementing the 2018 administrative costs and burdens, but
been determined to be a ‘‘significant’’ Requirements during the period of would not represent an overall cost
regulatory action. This regulation has July 2018 through January of 2019. savings. We continue to believe that the
been designated as ‘‘regulatory’’ under Similarly, the assumption that, in original compliance date of this
Executive Order 13771 (Reducing almost all categories described in the provision in January 2020 gives
Regulation and Controlling Regulatory RIA for the 2018 Requirements, the institutions sufficient time to prepare
Costs, issued on January 30, 2017). We benefits (cost-savings) associated with and implement this requirement. While
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estimate that this rule generates $2.02 delaying the 2018 Requirements by these commenters anecdotally indicated
million in annualized costs at a 7% six months are what would have been that implementing this requirement has
discount rate, discounted relative to the costs of implementing the 2018 been more costly to institutions than the
year 2016, over a perpetual time Requirements during the period of January 19, 2017 final rule preamble
horizon. Details on the estimated costs July 2018 through January of 2019. estimated, no commenter provided data
of this final rule can be found in the —That some entities will experience about the actual costs to implement this
economic analysis below. cost savings as a result of this rule, provision. In the absence of specific

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data, we continue with our cost and Requirements as a base for estimating benefits of $6.4 million are estimated
benefit assumptions related to this benefits and costs of delaying the using a 3 percent discount rate;
provision. general implementation of the 2018 annualized benefits of $5.9 million are
Requirements by six months. The time estimated using a 7 percent discount
3. Analysis of Benefits (Cost-Savings)
period for the analysis in this RIA is the rate. Annualized costs of $37.2 million
and Costs (Foregone Benefits) 4
6-month period from July 2018 to are estimated using a 3 percent discount
The RIA for the 2018 Requirements January 2019. rate; annualized costs of $34.4 million
described the benefits and costs of 16 Table 1 summarizes the quantified are estimated using a 7 percent discount
broad categories of changes finalized. benefits and costs of delaying the rate. Note that all values are represented
The RIA for this final rule uses the general implementation of 2018 in millions of 2016 dollars, and 2016 is
information and calculations described Requirements. Over the period of July used as the frame of reference for
in the preamble to the 2018 2018 to January 2019, annualized discounting.

TABLE 1—ALL BENEFITS AND COSTS OF DELAYING THE GENERAL COMPLIANCE DATE FOR THE 2018 REQUIREMENTS BY 6
MONTHS
[From July 19, 2018 to January 21, 2019]

Annualized value by
discount rate
(millions of 2016 dollars)

3 Percent 7 Percent

Benefits (Cost-Savings):
Quantified Benefits ........................................................................................................................................... 6.4 5.9
Costs (Foregone Benefits):
Quantified Costs ............................................................................................................................................... 37.4 34.7

The estimated benefits and costs of months are shown in Table 2 below. used in the RIA of the 2018
delaying the general implementation Note that the categorization shown Requirements.
date of the 2018 Requirements by 6 below includes the same 16 categories

TABLE 2—ACCOUNTING TABLE OF QUANTIFIED BENEFITS (COST-SAVINGS) AND COSTS (FOREGONE BENEFITS) OF
DELAYING COMPLIANCE WITH THE 2018 REQUIREMENTS BY 6 MONTHS 5
Annualized value over 1 year by discount rate
(millions of 2016 dollars)
2018 Requirement RIA Category Benefits (cost-savings) Costs (foregone benefits)

3% 7% 3% 7%

Regulated Community Learning New Requirements and Developing Train-


ing Materials; OHRP Developing Training and Guidance Materials, and
Implementing the 2018 Requirements ......................................................... ........................ ........................ ........................ ........................
Extending Oversight to IRBs Unaffiliated with an Institution Holding an FWA
(impact to IRBs not operated by an FWA-holding institution) ..................... 4.47 4.14 ........................ ........................
Excluding Activities from the Requirements of the Common Rule Because
They Are Not Research ............................................................................... ........................ ........................ 0.95 0.88
Clarifying and Harmonizing Regulatory Requirements and Agency Guidance ........................ ........................ ........................ ........................
Modifying the Assurance Requirements .......................................................... ........................ ........................ 0.31 0.29
Requirement for Written Procedures and Agreements for Reliance on IRBs
Not Operated by the Engaged Institution (impact to FWA-holding institu-
tions) ............................................................................................................. ........................ ........................ ........................ ........................
Eliminating the Requirement that the Grant Application or Proposal Undergo
IRB Review and Approval ............................................................................ ........................ ........................ 8.5 7.9
Expansion of Research Activities Exempt from Full IRB Review ................... 0.01 0.01 20.8 19.3
Elimination of Continuing Review of Research Under Specific Conditions .... 1.04 0.96 4.10 3.80
Amending the Expedited Review Procedures ................................................. ........................ ........................ 2.66 2.47
Cooperative Research (single IRB mandate in multi-institutional research) 6 ........................ ........................ ........................ ........................
Changes in the Basic Elements of Consent, Including Documentation .......... ........................ ........................ ........................ ........................
Obtaining Consent to Secondary Use of Identifiable Biospecimens and
Identifiable Private Information .................................................................... ........................ ........................ ........................ ........................
Elimination of Pre-2018 Rule Requirement to Waive Consent in Certain
Subject Recruitment Activities ..................................................................... ........................ ........................ 0.07 0.06
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Requirement for Posting of Consent Forms for Clinical Trials Conducted or


supported by Common Rule Departments or Agencies .............................. 0.85 0.79 ........................ ........................
Alteration in Waiver for Documentation of Informed Consent in Certain Cir-
cumstances .................................................................................................. ........................ ........................ ........................ ........................

4 Note, that the terms ‘‘benefits’’ and ‘‘cost- Similarly, the terms ‘‘costs’’ and ‘‘foregone benefits’’
savings’’ are used interchangeably in this RIA. are also used interchangeably.

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TABLE 2—ACCOUNTING TABLE OF QUANTIFIED BENEFITS (COST-SAVINGS) AND COSTS (FOREGONE BENEFITS) OF
DELAYING COMPLIANCE WITH THE 2018 REQUIREMENTS BY 6 MONTHS 5—Continued
Annualized value over 1 year by discount rate
(millions of 2016 dollars)
2018 Requirement RIA Category Benefits (cost-savings) Costs (foregone benefits)

3% 7% 3% 7%

Cost Savings, as indicated by public comments (unable to attribute to par-


ticular provisions) ......................................................................................... Unquantified ........................ ........................

We assume that in almost all b. Early Implementation of the Three assume that the foregone benefits (costs)
categories described in the RIA for the Burden-Reducing Provisions of the 2018 of delaying implementation of these
2018 Requirements the foregone benefits Requirements (Explicit Carve-Outs of provisions are what would have been
(costs) of delaying the 2018 Activities From the Definition of the benefits of implementing these
Requirements by 6 months are what Research [§ lll.102(l)]; Eliminating provisions in January 2018. Similarly,
would have been the benefits of the Requirement That the Grant we assume that the benefits (cost-
implementing the 2018 Requirements Application or Other Funding Proposal savings) associated with delaying the
during the period of July 2018 through Undergo IRB Review and Approval [Pre- implementation of these provisions are
January 2019. Similarly, we assume 2018 Rule at § lll.103(f)]; what would have been the costs of
that, in almost all categories described Elimination of Continuing Review of implementing these provisions in July
in the RIA for the 2018 Requirements, Research Under Specific Conditions 2018. We assume that these regulated
the benefits (cost-savings) associated [§§ lll.109(f) and lll.115(a)(3)] entities account for 50 percent of the
with delaying the 2018 Requirements by We assume that 50 percent of costs and benefits that would have been
6 months are what would have been the regulated entities will take advantage of experienced in 2018 absent this delay.
costs of implementing the 2018 the option included in this final rule to We also assume that institutional or
Requirements during the period of July implement three burden-reducing IRB staff at the IRB Administrative staff
2018 through January 2019. We assume provisions of the 2018 Requirements level 7 will spend 5 minutes per
this because regulated entities likely prior to the general compliance date. We protocol documenting the voluntary
would not have difficulty implementing assume this because an institution’s election to use the three burden-
these provisions in the absence of decision about whether to transition a reducing 2018 provisions during the
guidance from Common Rule time period of July 19, 2018 to January
study to the 2018 Requirements to take
departments or agencies, and thus could 21, 2019.
advantage of the three burden-reducing
have been implemented as assumed in Some members of the regulated
provisions might vary depending on the
the economic analysis contained in the community have indicated that even
nature and progress of the study,
RIA for the 2018 Requirements.5 6 though the 2018 Requirements yield
Categories with different assumptions including any elements of the study to
be conducted on or after January 21, cost savings, these institutions are still
are described below. hesitant to transition ongoing research
a. Regulated Community Learning 2019. For example, studies planning to
recruit some subjects on or after January to the 2018 Requirements, largely
New Requirements and Developing because of the burden of making studies
Training Materials; OHRP Developing 21, 2019 would have to meet the new
requirements for obtaining the informed already in compliance with the pre-2018
Training and Guidance Materials, and requirements comply with the 2018
Implementing the 2018 Requirements consent of those subjects. In contrast, for
studies whose remaining activities requirements. Also, some institutions
We assume that even with the seem inclined to make all of the
proposed 6-month delay, regulated consist only of completing data
analyses, the new requirements for transitions at once. This
entities and OHRP will still assume interconnectedness is key to some of the
costs related to learning the new informed consent would generally not
be applicable. Therefore, we assume assumptions noted elsewhere in this
requirements and developing training analysis. For example, if the three
materials. Thus, there are no effects that there are situations in which an
institution would want to take burden-reducing provisions are
estimated here. considered on their own, a reasonable
We expect that some entities would advantage of the three burden-reducing
provisions, and situations in which an assumption would be that 100 percent
experience cost savings as a result of
institution would not want to take of affected entities would realize the
this final rule, and some entities will
advantage of this flexibility. We note associated cost savings as soon as
experience costs as a result of this rule,
that we intend to publish guidance on possible. The use, instead, of a 50
but we lack data to quantify these
the carve-outs from the definition of percent estimate reflects entities’
effects.
research prior to July 19, 2018, which possible inclinations to make all
5 Zeroes in Table 2 (represented by —) signify that may also impact an institution’s transitions at once.
the category has been unaffected by the 6-month decision to elect to implement the three c. Expansion of Research Activities
delay of the 2018 Requirements. The category could
be unaffected for one of two reasons: (1) No costs
burden-reducing provisions or not. Exempt From Full IRB Review (§ lll
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or benefits were associated with the category in the Thus, these entities will still obtain .104(d))
RIA for the 2018 Requirements; or (2) the costs and the benefits and costs described in the
The 2018 Requirements include five
benefits of the provision during the 6-month delay RIA for the 2018 Requirements,
are the same as those estimated in the RIA for the new exemption categories and modify
implying no effects of this rule for 50
2018 Requirements.
6 Because compliance with this provision is not percent of regulated entities. For the 7 See the RIA to the 2018 Requirements (82 FR

required until 2020, benefits and costs here are not regulated entities that do not take 7149) for more information about the labor
included. advantage of these flexibilities, we categories used in this analysis.

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all but one exemption that exist in the would not have taken advantage of the 4. Analysis of Final Rule Alternative
pre-2018 Requirements. We have expansion in exemptions during this six An alternative to the proposal
received feedback from SACHRP that month-delay. For these entities, we finalized in this rule was to delay the
guidance will be useful for regulated assume that there are no benefits and effective date and general compliance
entities to implement many of the costs of the proposed delay, because date to January 21, 2019.
exemption categories.8 Areas where they would not have changed their Table 3 summarizes the quantified
significant guidance will be helpful operations. We assume that 50 percent benefits and costs of the alternative
include: Applying the categories of the of the regulated entities would have proposal of delaying the general
new exemptions themselves, conducting gone forward with using the new or implementation of 2018 Requirements
limited IRB review (as required in four expanded exemption categories under without the option to implement certain
exemptions), developing and using the 2018 Requirements; for these provisions of the 2018 Requirements.
broad consent (as required in two entities, there are costs of delaying the Over the period of July 2018 to January
exemptions), utilizing the exemption for implementation of this provision during 2019, annualized benefits of $7.4
certain HIPAA covered activities, and the six-month delay proposed in this million are estimated using a 3 percent
understanding which federally discount rate; annualized benefits of
NPRM.
supported or conducted nonresearch $6.9 million are estimated using a 7
information collections qualify for We do not have data to support our
percent discount rate. Annualized costs
exemption. assumption of what percent of regulated
of $50.8 million are estimated using a 3
Because the guidance documents that entities would have gone forward with percent discount rate; annualized costs
would be helpful to assist regulated the implementation of these provisions of $47.0 million are estimated using a 7
entities in implementing these in the absence of additional guidance, percent discount rate. Note that all
provisions of the 2018 Requirements and what percent would not have gone values are represented in millions of
have not yet been issued, we assume forward. 2016 dollars, and 2016 is used as the
that 50 percent of the regulated entities frame of reference for discounting.
TABLE 3—ALL BENEFITS AND COSTS OF DELAYING COMPLIANCE WITH THE 2018 REQUIREMENTS UNDER THE
ALTERNATIVE PROPOSAL
Annualized value by
discount rate
(millions of 2016 dollars)

3 Percent 7 Percent

Benefits (Cost–Savings):
Quantified Benefits: .......................................................................................................................................... 7.4 6.9
Costs (Foregone Benefits):
Quantified Costs ............................................................................................................................................... 50.8 47.0

B. Paperwork Reduction Act (PRA) involved in human subjects research reducing 2018 Requirements instead of,
This final rule contains collections of conducted or supported or otherwise or in addition to, the comparable
information that are subject to review subject to regulation by any federal provisions of the pre-2018
and approval by the Office of department or agency that takes Requirements. As discussed above, the
Management and Budget (OMB) under administrative action that makes the three burden-reducing 2018
the Paperwork Reduction Act (PRA), as policy applicable to such research. Requirements are (1) the 2018
amended (44 U.S.C. 3501–3520). A § lll.101(l)(4) Compliance Date and Requirements’ definition of ‘‘research’’
description of these provisions is given Transition Provision (OMB Control No at § lll.102(l) (instead of § lll
in this document with an estimate of the 0990–0260) .102(d) of the pre-2018 Requirements),
annual reporting and recordkeeping which deems certain activities not to be
burden. Section 101(l)(4)(i) permits studies to research, (2) the elimination of the
Title: Federal Policy for the Protection transition to the 2018 Requirements requirement that an IRB review the
of Human Subjects. between July 19, 2018 and January 21, grant application or proposal related to
Description: In this document is a 2019 (which would be the new general the research at § lll.103(d) of the
discussion of the regulatory provisions compliance date for the 2018 2018 Requirements (instead of § lll
we believe are subject to the PRA and Requirements). Between July 19, 2018
.103(f) of the pre-2018 Requirements),
the probable information collection and January 21, 2019, institutions that
and (3) the elimination of the
burden associated with these elect to transition studies to the 2018
requirement for annual continuing
provisions. In general, the following Requirements would, after the decision
to transition has been documented, be review of certain categories of research
actions trigger the PRA: (i) Reporting; at § lll.109(f)(1)(i) and (iii) of the
(ii) Recordkeeping. able to take advantage of the three
burden-reducing 2018 Requirements. 2018 Requirements (instead of § lll
Description of Respondents: The
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.103(b), as related to the requirement for


reporting and recordkeeping This option is described in a revision
continuing review, and in addition to
requirements in this document are to § lll.101(l)(4)(i). As described,
§ lll.109 of the pre-2018
imposed on institutions, institutional studies taking advantage of this option
review boards, and investigators would be subject to the three burden- Requirements).

8 See for example, SACHRP Recommendations of committee/recommendations/sachrp-


August 2, 2017: https://www.hhs.gov/ohrp/sachrp- recommendations/index.html.

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We estimate that approximately We have therefore concluded that this adding paragraph (l)(5) to read as
92,084 protocols would take advantage action will have no net regulatory follows:
of the voluntary election described in burden for all directly regulated small
§ lll.101 To what does this policy
§ lll.101(l)(4)(i). We estimate that entities.
apply?
institutional staff would spend 5
D. Unfunded Mandates Reform Act * * * * *
minutes per protocol documenting that
the study will be subject to the three (UMRA) (l) * * *
burden-reducing provisions of the 2018 Federal mandate that may result in (1) Pre-2018 Requirements. * * *
Requirements during the time period of the expenditure by State, local, and (2) 2018 Requirements. For purposes
July 19, 2018 through January 21, 2019. tribal governments, in the aggregate, or of this section, the 2018 Requirements
We estimate that this provision includes by the private sector, of $100,000,000 or means the Federal Policy for the
7,674 burden hours. more (adjusted annually for inflation) in Protection of Human Subjects
any one year.’’ In 2018, that threshold requirements contained in this [part/
C. Regulatory Flexibility Act (RFA) subpart]. The general compliance date
is approximately $150 million. We do
The Regulatory Flexibility Act (5 not expect this rule to result in for the 2018 Requirements is January 21,
U.S.C. 601 et seq.) (RFA) and the Small expenditures that will exceed this 2019. The compliance date for § lll
Business Regulatory Enforcement and amount. This action does not contain .114(b) (cooperative research) of the
Fairness Act of 1996, which amended any unfunded mandate as described in 2018 Requirements is January 20, 2020.
the RFA, require agencies that issue a UMRA, 2 U.S.C. 1531–1538, and does (3) Research subject to pre-2018
regulation to analyze options for not significantly or uniquely affect small requirements. The pre-2018
regulatory relief for small businesses. If governments.2 U.S.C. 1531–1538, and Requirements shall apply to the
a rule has a significant economic impact does not significantly or uniquely affect following research, unless the research
on a substantial number of small small governments. is transitioning to comply with the 2018
entities, agencies must specifically Requirements in accordance with
consider the economic effect of the rule E. Executive Order 13132: Federalism paragraph (l)(4) of this section:
on small entities and analyze regulatory (i) Research initially approved by an
Executive Order 13132 establishes
options that could lessen the impact of IRB under the pre-2018 Requirements
certain requirements that an agency
the rule. The RFA generally defines a before January 21, 2019;
must meet when it promulgates a rule
‘‘small entity’’ as (1) a proprietary firm (ii) Research for which IRB review
that imposes substantial direct
meeting the size standards of the Small was waived pursuant to § lll.101(i)
requirement costs on state and local
Business Administration (SBA); (2) a of the pre-2018 Requirements before
governments or has federalism
nonprofit organization that is not January 21, 2019; and
implications. We have determined that (iii) Research for which a
dominant in its field; or (3) a small
government jurisdiction with a this rule would not contain policies that determination was made that the
population of less than 50,000 (states would have substantial direct effects on research was exempt under § .101(b) of
and individuals are not included in the the States, on the relationship between the pre-2018 Requirements before
definition of ‘‘small entity’’). HHS the Federal Government and the States, January 21, 2019.
considers a rule to have a significant or on the distribution of power and (4) Transitioning research. If, on or
economic impact on a substantial responsibilities among the various after July 19, 2018, an institution
number of small entities if at least 5 levels of government. The changes in planning or engaged in research
percent of small entities experience an this rule represent the Federal otherwise covered by paragraph (l)(3) of
impact of more than 3 percent of Government regulating its own program. this section determines that such
revenue. Accordingly, we conclude that the rule research instead will transition to
We have determined that this final does not propose policies that have comply with the 2018 Requirements, the
rule will not have a significant federalism implications as defined in institution or an IRB must document
economic impact on a substantial Executive Order 13132 and, and date such determination.
number of small entities under the RFA. consequently, a federalism summary (i) If the determination to transition is
In making this determination, the impact statement is not required. documented between July 19, 2018, and
impact of concern is any significant For the reasons set forth in the January 20, 2019, the research shall:
adverse economic impact on small preamble, the Federal Policy for the (A) Beginning on the date of such
entities. An agency may certify that a Protection of Human Subjects, as documentation through January 20,
rule will not have a significant published in the Federal Register on 2019, comply with the pre-2018
economic impact on a substantial January 19, 2017 (82 FR 7149) and as Requirements, except that the research
number of small entities if the rule adopted in a final rule published by the shall comply with the following:
relieves regulatory burden, has no net CPSC on September 18, 2017 (82 FR (1) Section lll.102(l) of the 2018
burden or otherwise has a positive 43459), and as amended in a final rule Requirements (definition of research)
economic effect on the small entities published in the Federal Register on (instead of § lll.102(d) of the pre-
subject to the rule. This final rule would January 22, 2018 (83 FR 2885) and 2018 Requirements);
not impose a regulatory burden for adopted by HUD through a final rule (2) Section lll.103(d) of the 2018
regulated small entities because it published on January 26, 2018 (83 FR Requirements (revised certification
would delay the general compliance 3589), is further amended as follows: requirement that eliminates IRB review
date for the 2018 Requirements, of application or proposal) (instead of
Text of the Amended Common Rule
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allowing the status quo to be retained § lll.103(f) of the pre-2018


for the period of delay. Additionally, PARTll—PROTECTION OF HUMAN Requirements); and
regulated small entities are permitted to SUBJECTS (3) Section lll.109(f)(1)(i) and (iii)
comply voluntarily with those aspects of the 2018 Requirements (exceptions to
of the 2018 Requirements that do not 1. Amend § lll.101 by adding a mandated continuing review) (instead of
conflict with the pre-2018 heading for paragraph (l)(1), revising § lll.103(b), as related to the
Requirements, prior to January 21, 2019. paragraphs (l)(2), (3), and (4), and requirement for continuing review, and

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28510 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

in addition to § lll.109, of the pre- following research, unless the research (iii) Research for which a
2018 Requirements); and is transitioning to comply with the 2018 determination is made that the research
(B) Beginning on January 21, 2019, Requirements in accordance with is exempt on or after January 21, 2019.
comply with the 2018 Requirements. paragraph (l)(4) of this section: * * * * *
(ii) If the determination to transition (i) Research initially approved by an
is documented on or after January 21, Claire M. Grady,
IRB under the pre-2018 Requirements
2019, the research shall, beginning on Deputy Secretary (Acting), Department of
before January 21, 2019;
the date of such documentation, comply Homeland Security.
with the 2018 Requirements. (ii) Research for which IRB review
was waived pursuant to § 46.101(i) of DEPARTMENT OF AGRICULTURE
(5) Research subject to 2018
Requirements. The 2018 Requirements the pre-2018 Requirements) before List of Subjects in 7 CFR Part 1c
shall apply to the following research: January 21, 2019; and
Human research subjects, Reporting
(i) Research initially approved by an (iii) Research for which a and recordkeeping requirements,
IRB on or after January 21, 2019; determination was made that the Research.
(ii) Research for which IRB review is research was exempt under § 46.101(b)
of the pre-2018 Requirements before For the reasons stated in the
waived pursuant to paragraph (i) of this
January 21, 2019. preamble, Department of Agriculture
section on or after January 21, 2019; and
(iii) Research for which a further amends 7 CFR part 1c as
(4) Transitioning research. If, on or published in the Federal Register on
determination is made that the research after July 19, 2018, an institution
is exempt on or after January 21, 2019. January 19, 2017 (82 FR 7149), and as
planning or engaged in research amended in an interim final rule
* * * * * otherwise covered by paragraph (l)(3) of published in the Federal Register on
this section determines that such January 22, 2018 (83 FR 2885), as
DEPARTMENT OF HOMELAND
research instead will transition to follows:
SECURITY
comply with the 2018 Requirements, the
List of Subjects in 6 CFR Part 46 institution or an IRB must document PART 1c—PROTECTION OF HUMAN
Human research subjects, Reporting and date such determination. SUBJECTS
and recordkeeping requirements, (i) If the determination to transition is
Research. documented between July 19, 2018, and ■ 1. The authority citation for part 1c
January 20, 2019, the research shall: continues to read as follows:
For the reasons stated in the
preamble, Department of Homeland (A) Beginning on the date of such Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
Security further amends 6 CFR part 46 documentation through January 20, 1(b).
as published in the Federal Register on 2019, comply with the pre-2018 ■ 2. Amend § 1c.101 by adding a
January 19, 2017 (82 FR 7149), and as Requirements, except that the research heading for paragraph (l)(1), revising
amended in an interim final rule shall comply with the following: paragraphs (l)(2), (3), and (4), and
published in the Federal Register on (1) Section 46.102(l) of the 2018 adding paragraph (l)(5) to read as
January 22, 2018 (83 FR 2885), as Requirements (definition of research) follows:
follows: (instead of § 46.102(d) of the pre-2018
§ 1c.101 To what does this policy apply?
Requirements);
PART 46—PROTECTION OF HUMAN * * * * *
SUBJECTS (2) Section 46.103(d) of the 2018 (l) * * *
Requirements (revised certification (1) Pre-2018 Requirements. * * *
■ 1. The authority citation for part 46 requirement that eliminates IRB review (2) 2018 Requirements. For purposes
continues to read as follows: of application or proposal) (instead of of this section, the 2018 Requirements
§ 46.103(f) of the pre-2018 means the Federal Policy for the
Authority: 5 U.S.C. 301; Pub. L. 107–296,
sec. 102, 306(c); Pub. L. 108–458, sec. 8306. Requirements); and Protection of Human Subjects
(3) Section 46.109(f)(1)(i) and (iii) of requirements contained in this part. The
■ 2. Amend § 46.101 by adding a
the 2018 Requirements (exceptions to general compliance date for the 2018
heading for paragraph (l)(1), revising
mandated continuing review) (instead of Requirements is January 21, 2019. The
paragraphs (l)(2), (3), and (4), and
§ 46.103(b), as related to the compliance date for § 1c.114(b)
adding paragraph (l)(5) to read as
requirement for continuing review, and (cooperative research) of the 2018
follows:
in addition to § 46.109, of the pre-2018 Requirements is January 20, 2020.
§ 46.101 To what does this policy apply? Requirements); and (3) Research subject to pre-2018
* * * * * (B) Beginning on January 21, 2019, requirements. The pre-2018
(l) * * * comply with the 2018 Requirements. Requirements shall apply to the
(1) Pre-2018 Requirements. * * * (ii) If the determination to transition following research, unless the research
(2) 2018 Requirements. For purposes is documented on or after January 21, is transitioning to comply with the 2018
of this section, the 2018 Requirements 2019, the research shall, beginning on Requirements in accordance with
means the Federal Policy for the the date of such documentation, comply paragraph (l)(4) of this section:
Protection of Human Subjects with the 2018 Requirements. (i) Research initially approved by an
requirements contained in this part. The IRB under the pre-2018 Requirements
(5) Research subject to 2018 before January 21, 2019;
general compliance date for the 2018
Requirements. The 2018 Requirements
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Requirements is January 21, 2019. The (ii) Research for which IRB review
shall apply to the following research: was waived pursuant to § 1c.101(i) of
compliance date for § 46.114(b)
(cooperative research) of the 2018 (i) Research initially approved by an the pre-2018 Requirements before
Requirements is January 20, 2020. IRB on or after January 21, 2019; January 21, 2019; and
(3) Research subject to pre-2018 (ii) Research for which IRB review is (iii) Research for which a
requirements. The pre-2018 waived pursuant to paragraph (i) of this determination was made that the
Requirements shall apply to the section on or after January 21, 2019; and research was exempt under § 1c.101(b)

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of the pre-2018 Requirements before the Federal Register on January 19, (1) Section 745.102(l) of the 2018
January 21, 2019. 2017 (82 FR 7149), and as amended in Requirements (definition of research)
(4) Transitioning research. If, on or an interim final rule published in the (instead of § 745.102(d) of the pre-2018
after July 19, 2018, an institution Federal Register on January 22, 2018 Requirements);
planning or engaged in research (83 FR 2885), as follows: (2) Section 745.103(d) of the 2018
otherwise covered by paragraph (l)(3) of Requirements (revised certification
this section determines that such PART 745—PROTECTION OF HUMAN requirement that eliminates IRB review
research instead will transition to SUBJECTS of application or proposal) (instead of
comply with the 2018 Requirements, the § 745.103(f) of the pre-2018
■ 1. The authority citation for part 745 Requirements); and
institution or an IRB must document
continues to read as follows: (3) Section 745.109(f)(1)(i) and (iii) of
and date such determination.
(i) If the determination to transition is Authority: 5 U.S.C. 301; 42 U.S.C. 7254; the 2018 Requirements (exceptions to
documented between July 19, 2018, and 42 U.S.C. 300v–1(b). mandated continuing review) (instead of
January 20, 2019, the research shall: ■ 2. Amend § 745.101 by adding a § 745.103(b), as related to the
(A) Beginning on the date of such heading for paragraph (l)(1), revising requirement for continuing review, and
documentation through January 20, paragraphs (l)(2), (3), and (4), and in addition to § 745.109, of the pre-2018
2019, comply with the pre-2018 adding paragraph (l)(5) to read as Requirements); and
Requirements, except that the research follows: (B) Beginning on January 21, 2019,
shall comply with the following: comply with the 2018 Requirements.
(1) Section 1c.102(l) of the 2018 § 745.101 To what does this policy apply? (ii) If the determination to transition
Requirements (definition of research) * * * * * is documented on or after January 21,
(instead of § 1c.102(d) of the pre-2018 (l) * * * 2019, the research shall, beginning on
Requirements); (1) Pre-2018 Requirements. * * * the date of such documentation, comply
(2) Section 1c.103(d) of the 2018 (2) 2018 Requirements. For purposes with the 2018 Requirements.
Requirements (revised certification of this section, the 2018 Requirements (5) Research subject to 2018
requirement that eliminates IRB review means the Federal Policy for the Requirements. The 2018 Requirements
of application or proposal) (instead of Protection of Human Subjects shall apply to the following research:
§ 1c.103(f) of the pre-2018 requirements contained in this part. The (i) Research initially approved by an
Requirements); and general compliance date for the 2018 IRB on or after January 21, 2019;
(3) Section 1c.109(f)(1)(i) and (iii) of Requirements is January 21, 2019. The (ii) Research for which IRB review is
the 2018 Requirements (exceptions to compliance date for § 745.114(b) waived pursuant to paragraph (i) of this
mandated continuing review) (instead of (cooperative research) of the 2018 section on or after January 21, 2019; and
§ 1c.103(b), as related to the requirement Requirements is January 20, 2020. (iii) Research for which a
for continuing review, and in addition (3) Research subject to pre-2018 determination is made that the research
to § 1c.109, of the pre-2018 requirements. The pre-2018 is exempt on or after January 21, 2019.
Requirements); and Requirements shall apply to the * * * * *
(B) Beginning on January 21, 2019, following research, unless the research
is transitioning to comply with the 2018 Dan Brouillette,
comply with the 2018 Requirements.
(ii) If the determination to transition Requirements in accordance with Deputy Secretary of Energy.
is documented on or after January 21, paragraph (l)(4) of this section: NATIONAL AERONAUTICS AND
2019, the research shall, beginning on (i) Research initially approved by an
SPACE ADMINISTRATION
the date of such documentation, comply IRB under the pre-2018 Requirements
with the 2018 Requirements. before January 21, 2019; List of Subjects in 14 CFR Part 1230
(ii) Research for which IRB review
(5) Research subject to 2018 Human research subjects, Reporting
was waived pursuant to § 745.101(i) of
Requirements. The 2018 Requirements and recordkeeping requirements,
the pre-2018 Requirements before
shall apply to the following research: Research.
January 21, 2019; and
(i) Research initially approved by an For the reasons stated in the
(iii) Research for which a
IRB on or after January 21, 2019; preamble, National Aeronautics and
determination was made that the
(ii) Research for which IRB review is Space Administration further amends
research was exempt under § 745.101(b)
waived pursuant to paragraph (i) of this 14 CFR part 1230 as published in the
of the pre-2018 Requirements before
section on or after January 21, 2019; and Federal Register on January 19, 2017
January 21, 2019.
(iii) Research for which a (4) Transitioning research. If, on or (82 FR 7149), and as amended in an
determination is made that the research after July 19, 2018, an institution interim final rule published in the
is exempt on or after January 21, 2019. planning or engaged in research Federal Register on January 22, 2018
* * * * * otherwise covered by paragraph (l)(3) of (83 FR 2885), as follows:
Chavonda Jacobs-Young, this section determines that such
PART 1230—PROTECTION OF HUMAN
Acting Deputy Under Secretary for Research, research instead will transition to
SUBJECTS
Education, and Economics, USDA. comply with the 2018 Requirements, the
institution or an IRB must document ■ 1. The authority citation for part 1230
DEPARTMENT OF ENERGY and date such determination. continues to read as follows:
List of Subjects in 10 CFR Part 745 (i) If the determination to transition is
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documented between July 19, 2018, and Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
Human research subjects, Reporting 1(b).
January 20, 2019, the research shall:
and recordkeeping requirements, (A) Beginning on the date of such ■ 2. Amend § 1230.101 by adding a
Research. documentation through January 20, heading for paragraph (l)(1), revising
For the reasons stated in the 2019, comply with the pre-2018 paragraphs (l)(2), (3), and (4), and
preamble, Department of Energy further Requirements, except that the research adding paragraph (l)(5) to read as
amends 10 CFR part 745 as published in shall comply with the following: follows:

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28512 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

§ 1230.101 To what does this policy apply? (ii) If the determination to transition is transitioning to comply with the 2018
* * * * * is documented on or after January 21, Requirements in accordance with
(l) * * * 2019, the research shall, beginning on paragraph (l)(4) of this section:
(1) Pre-2018 Requirements. * * * the date of such documentation, comply (i) Research initially approved by an
(2) 2018 Requirements. For purposes with the 2018 Requirements. IRB under the pre-2018 Requirements
of this section, the 2018 Requirements (5) Research subject to 2018 before January 21, 2019;
means the Federal Policy for the Requirements. The 2018 Requirements
Protection of Human Subjects shall apply to the following research: (ii) Research for which IRB review
requirements contained in this part. The (i) Research initially approved by an was waived pursuant to § 27.101(i) of
general compliance date for the 2018 IRB on or after January 21, 2019; the pre-2018 Requirements before
Requirements is January 21, 2019. The (ii) Research for which IRB review is January 21, 2019; and
compliance date for § 1230.114(b) waived pursuant to paragraph (i) of this (iii) Research for which a
(cooperative research) of the 2018 section on or after January 21, 2019; and determination was made that the
Requirements is January 20, 2020. (iii) Research for which a research was exempt under § 27.101(b)
(3) Research subject to pre-2018 determination is made that the research of the pre-2018 Requirements before
requirements. The pre-2018 is exempt on or after January 21, 2019. January 21, 2019.
Requirements shall apply to the * * * * * (4) Transitioning research. If, on or
following research, unless the research after July 19, 2018, an institution
is transitioning to comply with the 2018 James D. Polk,
planning or engaged in research
Requirements in accordance with Chief Health & Medical Officer, National
otherwise covered by paragraph (l)(3) of
paragraph (l)(4) of this section: Aeronautics and Space Administration.
this section determines that such
(i) Research initially approved by an DEPARTMENT OF COMMERCE research instead will transition to
IRB under the pre-2018 Requirements comply with the 2018 Requirements, the
before January 21, 2019; List of Subjects in 15 CFR Part 27
institution or an IRB must document
(ii) Research for which IRB review Human research subjects, Reporting and date such determination.
was waived pursuant to § 1230.101(i) of and recordkeeping requirements,
the pre-2018 Requirements before (i) If the determination to transition is
Research. documented between July 19, 2018, and
January 21, 2019; and
(iii) Research for which a For the reasons stated in the January 20, 2019, the research shall:
determination was made that the preamble, Department of Commerce
further amends 15 CFR part 27 as (A) Beginning on the date of such
research was exempt under documentation through January 20,
§ 1230.101(b) of the pre-2018 published in the Federal Register on
January 19, 2017 (82 FR 7149), and as 2019, comply with the pre-2018
Requirements before January 21, 2019. Requirements, except that the research
(4) Transitioning research. If, on or amended in an interim final rule
published in the Federal Register on shall comply with the following:
after July 19, 2018, an institution
January 22, 2018 (83 FR 2885), as (1) Section 27.102(l) of the 2018
planning or engaged in research
follows: Requirements (definition of research)
otherwise covered by paragraph (l)(3) of
(instead of § 27.102(d) of the pre-2018
this section determines that such
PART 27—PROTECTION OF HUMAN Requirements);
research instead will transition to
SUBJECTS (2) Section 27.103(d) of the 2018
comply with the 2018 Requirements, the
institution or an IRB must document ■ 1. The authority citation for part 27 Requirements (revised certification
and date such determination. continues to read as follows: requirement that eliminates IRB review
(i) If the determination to transition is of application or proposal) (instead of
documented between July 19, 2018, and Authority: 5 U.S.C. 301; 42 U.S.C. 300v– § 27.103(f) of the pre-2018
1(b). Requirements); and
January 20, 2019, the research shall:
(A) Beginning on the date of such ■ 2. Amend § 27.101 by adding a (3) Section 27.109(f)(1)(i) and (iii) of
documentation through January 20, heading for paragraph (l)(1), revising the 2018 Requirements (exceptions to
2019, comply with the pre-2018 paragraphs (l)(2), (3), and (4), and mandated continuing review) (instead of
Requirements, except that the research adding paragraph (l)(5) to read as § 27.103(b), as related to the
shall comply with the following: follows: requirement for continuing review, and
(1) Section 1230.102(l) of the 2018 in addition to § 27.109, of the pre-2018
Requirements (definition of research) § 27.101 To what does this policy apply?
Requirements); and
(instead of § 1230.102(d) of the pre-2018 * * * * *
Requirements); (l) * * * (B) Beginning on January 21, 2019,
(2) Section 1230.103(d) of the 2018 (1) Pre-2018 Requirements. * * * comply with the 2018 Requirements.
Requirements (revised certification (2) 2018 Requirements. For purposes (ii) If the determination to transition
requirement that eliminates IRB review of this section, the 2018 Requirements is documented on or after January 21,
of application or proposal) (instead of means the Federal Policy for the 2019, the research shall, beginning on
§ 1230.103(f) of the pre-2018 Protection of Human Subjects the date of such documentation, comply
Requirements); and requirements contained in this part. The with the 2018 Requirements.
(3) Section 1230.109(f)(1)(i) and (iii) general compliance date for the 2018 (5) Research subject to 2018
of the 2018 Requirements (exceptions to Requirements is January 21, 2019. The Requirements. The 2018 Requirements
daltland on DSKBBV9HB2PROD with RULES2

mandated continuing review) (instead of compliance date for § 27.114(b) shall apply to the following research:
§ 1230.103(b), as related to the (cooperative research) of the 2018
requirement for continuing review, and Requirements is January 20, 2020. (i) Research initially approved by an
in addition to § 1230.109, of the pre- (3) Research subject to pre-2018 IRB on or after January 21, 2019;
2018 Requirements); and requirements. The pre-2018 (ii) Research for which IRB review is
(B) Beginning on January 21, 2019, Requirements shall apply to the waived pursuant to paragraph (i) of this
comply with the 2018 Requirements. following research, unless the research section on or after January 21, 2019; and

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(iii) Research for which a research was exempt under Administration further amends 20 CFR
determination is made that the research § 1028.101(b) of the pre-2018 part 431 as published in the Federal
is exempt on or after January 21, 2019. Requirements before January 21, 2019. Register on January 19, 2017 (82 FR
* * * * * (4) Transitioning research. If, on or 7149), and as amended in an interim
after July 19, 2018, an institution final rule published in the Federal
Wilbur L. Ross, planning or engaged in research Register on January 22, 2018 (83 FR
Secretary of Commerce. otherwise covered by paragraph (l)(3) of 2885), as follows:
CONSUMER PRODUCT SAFETY this section determines that such
COMMISSION research instead will transition to PART 431—PROTECTION OF HUMAN
comply with the 2018 Requirements, the SUBJECTS
List of Subjects in 16 CFR Part 1028 institution or an IRB must document
Human research subjects, Reporting and date such determination. ■ 1. The authority citation for part 431
and recordkeeping requirements, (i) If the determination to transition is continues to read as follows:
Research. documented between July 19, 2018, and Authority: 5 U.S.C. 301; 42 U.S.C. 289(a).
For the reasons stated in the January 20, 2019, the research shall: ■ 2. Amend § 431.101 by adding a
preamble, Consumer Product Safety (A) Beginning on the date of such heading for paragraph (l)(1), revising
Commission further amends 16 CFR documentation through January 20, paragraphs (l)(2), (3), and (4), and
part 1028 as published in the Federal 2019, comply with the pre-2018 adding paragraph (l)(5) to read as
Register on January 19, 2017 (82 FR Requirements, except that the research follows:
7149) and as adopted in a final rule shall comply with the following:
published by the CPSC on September (1) Section 1028.102(l) of the 2018 § 431.101 To what does this policy apply?
18, 2017 (82 FR 43459), and as amended Requirements (definition of research) * * * * *
in an interim final rule published in the (instead of § 1028.102(d) of the pre-2018 (l) * * *
Federal Register on January 22, 2018 Requirements); (1) Pre-2018 Requirements. * * *
(83 FR 2885), as follows: (2) Section 1028.103(d) of the 2018 (2) 2018 Requirements. For purposes
Requirements (revised certification of this section, the 2018 Requirements
PART 1028—PROTECTION OF HUMAN requirement that eliminates IRB review means the Federal Policy for the
SUBJECTS of application or proposal) (instead of Protection of Human Subjects
§ 1028.103(f) of the pre-2018 requirements contained in this part. The
■ 1. The authority citation for part 1028 Requirements); and
continues to read as follows: general compliance date for the 2018
(3) Section 1028.109(f)(1)(i) and (iii) Requirements is January 21, 2019. The
Authority: 5 U.S.C. 301; 42 U.S.C. 300v– of the 2018 Requirements (exceptions to compliance date for § 431.114(b)
1(b). mandated continuing review) (instead of (cooperative research) of the 2018
■ 2. Amend § 1028.101 by adding a § 1028.103(b), as related to the Requirements is January 20, 2020.
heading for paragraph (l)(1), revising requirement for continuing review, and (3) Research subject to pre-2018
paragraphs (l)(2), (3), and (4), and in addition to § 1028.109, of the pre- requirements. The pre-2018
adding paragraph (l)(5) to read as 2018 Requirements); and Requirements shall apply to the
follows: (B) Beginning on January 21, 2019, following research, unless the research
comply with the 2018 Requirements. is transitioning to comply with the 2018
§ 1028.101 To what does this policy apply? (ii) If the determination to transition Requirements in accordance with
* * * * * is documented on or after January 21, paragraph (l)(4) of this section:
(l) * * * 2019, the research shall, beginning on
(1) Pre-2018 Requirements. * * * (i) Research initially approved by an
the date of such documentation, comply IRB under the pre-2018 Requirements
(2) 2018 Requirements. For purposes with the 2018 Requirements.
of this section, the 2018 Requirements before January 21, 2019;
(5) Research subject to 2018 (ii) Research for which IRB review
means the Federal Policy for the Requirements. The 2018 Requirements
Protection of Human Subjects was waived pursuant to § 431.101(i) of
shall apply to the following research: the pre-2018 Requirements before
requirements contained in this part. The (i) Research initially approved by an
general compliance date for the 2018 January 21, 2019; and
IRB on or after January 21, 2019; (iii) Research for which a
Requirements is January 21, 2019. The (ii) Research for which IRB review is
compliance date for § 1028.114(b) determination was made that the
waived pursuant to paragraph (i) of this research was exempt under § 431.101(b)
(cooperative research) of the 2018 section on or after January 21, 2019; and
Requirements is January 20, 2020. of the pre-2018 Requirements before
(iii) Research for which a January 21, 2019.
(3) Research subject to pre-2018
determination is made that the research (4) Transitioning research. If, on or
requirements. The pre-2018
is exempt on or after January 21, 2019. after July 19, 2018, an institution
Requirements shall apply to the
following research, unless the research * * * * * planning or engaged in research
is transitioning to comply with the 2018 Alberta E. Mills,
otherwise covered by paragraph (l)(3) of
Requirements in accordance with this section determines that such
Secretary, Consumer Product Safety
paragraph (l)(4) of this section: Commission.
research instead will transition to
(i) Research initially approved by an comply with the 2018 Requirements, the
IRB under the pre-2018 Requirements SOCIAL SECURITY ADMINISTRATION institution or an IRB must document
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before January 21, 2019; List of Subjects in 20 CFR Part 431 and date such determination.
(ii) Research for which IRB review (i) If the determination to transition is
was waived pursuant to § 1028.101(i) of Human research subjects, Reporting documented between July 19, 2018, and
the pre-2018 Requirements before and recordkeeping requirements, January 20, 2019, the research shall:
January 21, 2019; and Research. (A) Beginning on the date of such
(iii) Research for which a For the reasons stated in the documentation through January 20,
determination was made that the preamble, Social Security 2019, comply with the pre-2018

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28514 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

Requirements, except that the research adding paragraph (l)(5) to read as (B) Beginning on January 21, 2019,
shall comply with the following: follows: comply with the 2018 Requirements.
(1) Section 431.102(l) of the 2018 (ii) If the determination to transition
Requirements (definition of research) § 225.101 To what does this policy apply?
is documented on or after January 21,
(instead of § 431.102(d) of the pre-2018 * * * * * 2019, the research shall, beginning on
Requirements); (l) * * * the date of such documentation, comply
(2) Section 431.103(d) of the 2018 (1) Pre-2018 Requirements. * * * with the 2018 Requirements.
Requirements (revised certification (2) 2018 Requirements. For purposes
(5) Research subject to 2018
requirement that eliminates IRB review of this section, the 2018 Requirements
Requirements. The 2018 Requirements
of application or proposal) (instead of means the Federal Policy for the
shall apply to the following research:
Protection of Human Subjects
§ 431.103(f) of the pre-2018 (i) Research initially approved by an
requirements contained in this part. The
Requirements); and IRB on or after January 21, 2019;
(3) Section 431.109(f)(1)(i) and (iii) of general compliance date for the 2018
(ii) Research for which IRB review is
Requirements is January 21, 2019. The
the 2018 Requirements (exceptions to waived pursuant to paragraph (i) of this
compliance date for § 225.114(b)
mandated continuing review) (instead of section on or after January 21, 2019; and
(cooperative research) of the 2018
§ 431.103(b), as related to the (iii) Research for which a
Requirements is January 20, 2020.
requirement for continuing review, and (3) Research subject to pre-2018 determination is made that the research
in addition to § 431.109, of the pre-2018 requirements. The pre-2018 is exempt on or after January 21, 2019.
Requirements); and Requirements shall apply to the * * * * *
(B) Beginning on January 21, 2019, following research, unless the research
comply with the 2018 Requirements. Irene Koek,
is transitioning to comply with the 2018
(ii) If the determination to transition Requirements in accordance with
Senior Deputy Assistant Administrator for
is documented on or after January 21, Global Health, U.S. Agency for International
paragraph (l)(4) of this section: Development.
2019, the research shall, beginning on (i) Research initially approved by an
the date of such documentation, comply IRB under the pre-2018 Requirements DEPARTMENT OF HOUSING AND
with the 2018 Requirements. before January 21, 2019; URBAN DEVELOPMENT
(5) Research subject to 2018 (ii) Research for which IRB review
Requirements. The 2018 Requirements List of Subjects in 24 CFR Part 60
was waived pursuant to § 225.101(i) of
shall apply to the following research: the pre-2018 Requirements before Human research subjects, Reporting
(i) Research initially approved by an January 21, 2019; and and recordkeeping requirements,
IRB on or after January 21, 2019; (iii) Research for which a Research.
(ii) Research for which IRB review is determination was made that the For the reasons stated in the
waived pursuant to paragraph (i) of this research was exempt under § 225.101(b) preamble, Department of Housing and
section on or after January 21, 2019; and of the pre-2018 Requirements before Urban Development further amends 24
(iii) Research for which a January 21, 2019. CFR part 60 as published in the Federal
determination is made that the research (4) Transitioning research. If, on or Register on January 19, 2017 (82 FR
is exempt on or after January 21, 2019. after July 19, 2018, an institution 7149), and as amended in an interim
* * * * * planning or engaged in research final rule published in the Federal
otherwise covered by paragraph (l)(3) of Register on January 22, 2018 (83 FR
Nancy Berryhill,
this section determines that such 2885), and adopted by HUD through an
Acting Commissioner of Social Security. research instead will transition to interim final rule published on January
AGENCY FOR INTERNATIONAL comply with the 2018 Requirements, the 26, 2018 (83 FR 3589), as follows:
DEVELOPMENT institution or an IRB must document
and date such determination. PART 60—PROTECTION OF HUMAN
List of Subjects in 22 CFR Part 225 (i) If the determination to transition is SUBJECTS
Human research subjects, Reporting documented between July 19, 2018, and
and recordkeeping requirements, January 20, 2019, the research shall: ■ 1. The authority citation for part 60
Research. (A) Beginning on the date of such continues to read as follows:
documentation through January 20,
For the reasons stated in the Authority: 5 U.S.C. 301; 42 U.S.C. 300v-
2019, comply with the pre-2018
preamble, Agency for International 1(b) and 3535(d).
Requirements, except that the research
Development further amends 22 CFR ■ 2. Amend § 60.101 by adding a
shall comply with the following:
part 225 as published in the Federal (1) Section 225.102(l) of the 2018 heading for paragraph (l)(1), revising
Register on January 19, 2017 (82 FR Requirements (definition of research) paragraphs (l)(2), (3), and (4), and
7149), and as amended in an interim (instead of § 225.102(d) of the pre-2018 adding paragraph (l)(5) to read as
final rule published in the Federal Requirements); follows:
Register on January 22, 2018 (83 FR (2) Section 225.103(d) of the 2018
2885), as follows: Requirements (revised certification § 60.101 To what does this policy apply?
requirement that eliminates IRB review * * * * *
PART 225—PROTECTION OF HUMAN (l) * * *
of application or proposal) (instead of
SUBJECTS (1) Pre-2018 Requirements. * * *
§ 225.103(f) of the pre-2018
■ 1. The authority citation for part 225 Requirements); and (2) 2018 Requirements. For purposes
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continues to read as follows: (3) Section 225.109(f)(1)(i) and (iii) of of this section, the 2018 Requirements
the 2018 Requirements (exceptions to means the Federal Policy for the
Authority: 5 U.S.C. 301; 42 U.S.C. 300v– mandated continuing review) (instead of Protection of Human Subjects
1(b), unless otherwise noted. § 225.103(b), as related to the requirements contained in this part. The
■ 2. Amend § 225.101 by adding a requirement for continuing review, and general compliance date for the 2018
heading for paragraph (l)(1), revising in addition to § 225.109, of the pre-2018 Requirements is January 21, 2019. The
paragraphs (l)(2), (3), and (4), and Requirements); and compliance date for § 60.114(b)

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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations 28515

(cooperative research) of the 2018 (ii) Research for which IRB review is (iii) Research for which a
Requirements is January 20, 2020. waived pursuant to paragraph (i) of this determination was made that the
(3) Research subject to pre-2018 section on or after January 21, 2019; and research was exempt under § 21.101(b)
requirements. The pre-2018 (iii) Research for which a of the pre-2018 Requirements before
Requirements shall apply to the determination is made that the research January 21, 2019.
following research, unless the research is exempt on or after January 21, 2019. (4) Transitioning research. If, on or
is transitioning to comply with the 2018 * * * * * after July 19, 2018, an institution
Requirements in accordance with planning or engaged in research
paragraph (l)(4) of this section: Todd M. Richardson, otherwise covered by paragraph (l)(3) of
(i) Research initially approved by an Acting General Deputy Assistant Secretary this section determines that such
for Policy Development and Research, U.S. research instead will transition to
IRB under the pre-2018 Requirements Department of Housing and Urban
before January 21, 2019; comply with the 2018 Requirements, the
Development.
(ii) Research for which IRB review institution or an IRB must document
was waived pursuant to § 60.101(i) of DEPARTMENT OF LABOR and date such determination.
the pre-2018 Requirements before (i) If the determination to transition is
List of Subjects in 29 CFR Part 21 documented between July 19, 2018, and
January 21, 2019; and
Human research subjects, Reporting January 20, 2019, the research shall:
(iii) Research for which a (A) Beginning on the date of such
and recordkeeping requirements,
determination was made that the documentation through January 20,
Research.
research was exempt under § 60.101(b) 2019, comply with the pre-2018
of the pre-2018 Requirements before For the reasons stated in the
preamble, Department of Labor further Requirements, except that the research
January 21, 2019. shall comply with the following:
(4) Transitioning research. If, on or amends 29 CFR part 21 as published in
the Federal Register on January 19, (1) Section 21.102(l) of the 2018
after July 19, 2018, an institution Requirements (definition of research)
planning or engaged in research 2017 (82 FR 7149), and as amended in
an interim final rule published in the (instead of § 21.102(d) of the pre-2018
otherwise covered by paragraph (l)(3) of Requirements);
this section determines that such Federal Register on January 22, 2018
(2) Section 21.103(d) of the 2018
research instead will transition to (83 FR 2885), as follows:
Requirements (revised certification
comply with the 2018 Requirements, the requirement that eliminates IRB review
PART 21—PROTECTION OF HUMAN
institution or an IRB must document of application or proposal) (instead of
SUBJECTS
and date such determination. § 21.103(f) of the pre-2018
(i) If the determination to transition is ■ 1. The authority citation for part 21 Requirements); and
documented between July 19, 2018, and continues to read as follows: (3) Section 21.109(f)(1)(i) and (iii) of
January 20, 2019, the research shall: the 2018 Requirements (exceptions to
Authority: 5 U.S.C. 301; 29 U.S.C. 551.
(A) Beginning on the date of such mandated continuing review) (instead of
documentation through January 20, ■ 2. Amend § 21.101 by adding a § 21.103(b), as related to the
2019, comply with the pre-2018 heading for paragraph (l)(1), revising requirement for continuing review, and
Requirements, except that the research paragraphs (l)(2), (3), and (4), and in addition to § 21.109, of the pre-2018
shall comply with the following: adding paragraph (l)(5) to read as Requirements); and
(1) Section 60.102(l) of the 2018 follows: (B) Beginning on January 21, 2019,
Requirements (definition of research) comply with the 2018 Requirements.
§ 21.101 To what does this policy apply? (ii) If the determination to transition
(instead of § 60.102(d) of the pre-2018
* * * * * is documented on or after January 21,
Requirements);
(l) * * * 2019, the research shall, beginning on
(2) Section 60.103(d) of the 2018 (1) Pre-2018 Requirements. * * *
Requirements (revised certification the date of such documentation, comply
(2) 2018 Requirements. For purposes with the 2018 Requirements.
requirement that eliminates IRB review of this section, the 2018 Requirements (5) Research subject to 2018
of application or proposal) (instead of means the Federal Policy for the Requirements. The 2018 Requirements
§ 60.103(f) of the pre-2018 Protection of Human Subjects shall apply to the following research:
Requirements); and requirements contained in this part. The (i) Research initially approved by an
(3) Section 60.109(f)(1)(i) and (iii) of general compliance date for the 2018 IRB on or after January 21, 2019;
the 2018 Requirements (exceptions to Requirements is January 21, 2019. The (ii) Research for which IRB review is
mandated continuing review) (instead of compliance date for § 21.114(b) waived pursuant to paragraph (i) of this
§ 60.103(b), as related to the (cooperative research) of the 2018 section on or after January 21, 2019; and
requirement for continuing review, and Requirements is January 20, 2020. (iii) Research for which a
in addition to § 60.109, of the pre-2018 (3) Research subject to pre-2018 determination is made that the research
Requirements); and requirements. The pre-2018 is exempt on or after January 21, 2019.
(B) Beginning on January 21, 2019, Requirements shall apply to the * * * * *
comply with the 2018 Requirements. following research, unless the research
(ii) If the determination to transition R. Alexander Acosta,
is transitioning to comply with the 2018
is documented on or after January 21, Secretary of Labor.
Requirements in accordance with
2019, the research shall, beginning on paragraph (l)(4) of this section: DEPARTMENT OF DEFENSE
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the date of such documentation, comply (i) Research initially approved by an


with the 2018 Requirements. IRB under the pre-2018 Requirements List of Subjects in 32 CFR Part 219
(5) Research subject to 2018 before January 21, 2019; Human research subjects, Reporting
Requirements. The 2018 Requirements (ii) Research for which IRB review and recordkeeping requirements,
shall apply to the following research: was waived pursuant to § 21.101(i) of Research.
(i) Research initially approved by an the pre-2018 Requirements before For the reasons stated in the
IRB on or after January 21, 2019; January 21, 2019; and preamble, Department of Defense

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28516 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

further amends 32 CFR part 219 as Requirements, except that the research paragraphs (l)(2), (3), and (4), and
published in the Federal Register on shall comply with the following: adding paragraph (l)(5) to read as
January 19, 2017 (82 FR 7149), and as (1) Section 219.102(l) of the 2018 follows:
amended in an interim final rule Requirements (definition of research)
published in the Federal Register on (instead of § 219.102(d) of the pre-2018 § 97.101 To what does this policy apply?
January 22, 2018 (83 FR 2885), as Requirements); * * * * *
follows: (2) Section 219.103(d) of the 2018 (l) * * *
Requirements (revised certification (1) Pre-2018 Requirements. * * *
PART 219—PROTECTION OF HUMAN requirement that eliminates IRB review (2) 2018 Requirements. For purposes
SUBJECTS of application or proposal) (instead of of this section, the 2018 Requirements
§ 219.103(f) of the pre-2018 means the Federal Policy for the
■ 1. The authority citation for part 219 Requirements); and Protection of Human Subjects
continues to read as follows: (3) Section 219.109(f)(1)(i) and (iii) of requirements contained in this subpart.
Authority: 5 U.S.C. 301; 42 U.S.C. 300v– the 2018 Requirements (exceptions to The general compliance date for the
1(b). mandated continuing review) (instead of 2018 Requirements is January 21, 2019.
■ 2. Amend § 219.101 by adding a § 219.103(b), as related to the The compliance date for § 97.114(b)
heading for paragraph (l)(1), revising requirement for continuing review, and (cooperative research) of the 2018
paragraphs (l)(2), (3), and (4), and in addition to § 219.109, of the pre-2018 Requirements is January 20, 2020.
Requirements); and (3) Research subject to pre-2018
adding paragraph (l)(5) to read as
(B) Beginning on January 21, 2019, requirements. The pre-2018
follows:
comply with the 2018 Requirements. Requirements shall apply to the
§ 219.101 To what does this policy apply? (ii) If the determination to transition following research, unless the research
* * * * * is documented on or after January 21, is transitioning to comply with the 2018
(l) * * * 2019, the research shall, beginning on Requirements in accordance with
(1) Pre-2018 Requirements. * * * the date of such documentation, comply paragraph (l)(4) of this section:
(2) 2018 Requirements. For purposes with the 2018 Requirements. (i) Research initially approved by an
of this section, the 2018 Requirements (5) Research subject to 2018 IRB under the pre-2018 Requirements
means the Federal Policy for the Requirements. The 2018 Requirements before January 21, 2019;
Protection of Human Subjects shall apply to the following research: (ii) Research for which IRB review
requirements contained in this part. The (i) Research initially approved by an was waived pursuant to § 97.101(i) of
general compliance date for the 2018 IRB on or after January 21, 2019; the pre-2018 Requirements before
Requirements is January 21, 2019. The (ii) Research for which IRB review is January 21, 2019; and
compliance date for § 219.114(b) waived pursuant to paragraph (i) of this (iii) Research for which a
(cooperative research) of the 2018 section on or after January 21, 2019; and determination was made that the
Requirements is January 20, 2020. (iii) Research for which a research was exempt under § 97.101(b)
(3) Research subject to pre-2018 determination is made that the research of the pre-2018 Requirements before
requirements. The pre-2018 is exempt on or after January 21, 2019. January 21, 2019.
Requirements shall apply to the (4) Transitioning research. If, on or
* * * * * after July 19, 2018, an institution
following research, unless the research
is transitioning to comply with the 2018 Mary J. Miller, planning or engaged in research
Requirements in accordance with Principal Deputy, Assistant Secretary of otherwise covered by paragraph (l)(3) of
paragraph (l)(4) of this section: Defense for Research and Engineering, U.S. this section determines that such
(i) Research initially approved by an Department of Defense. research instead will transition to
IRB under the pre-2018 Requirements comply with the 2018 Requirements, the
DEPARTMENT OF EDUCATION
before January 21, 2019; institution or an IRB must document
(ii) Research for which IRB review List of Subjects in 34 CFR Part 97 and date such determination.
was waived pursuant to § 219.101(i) of (i) If the determination to transition is
Human research subjects, Reporting
the pre-2018 Requirements before documented between July 19, 2018, and
and recordkeeping requirements,
January 21, 2019; and January 20, 2019, the research shall:
Research.
(iii) Research for which a (A) Beginning on the date of such
determination was made that the For the reasons stated in the documentation through January 20,
research was exempt under § 219.101(b) preamble, Department of Education 2019, comply with the pre-2018
of the pre-2018 Requirements before further amends 34 CFR part 97 as Requirements, except that the research
January 21, 2019. published in the Federal Register on shall comply with the following:
(4) Transitioning research. If, on or January 19, 2017 (82 FR 7149), and as (1) Section 97.102(l) of the 2018
after July 19, 2018, an institution amended in an interim final rule Requirements (definition of research)
planning or engaged in research published in the Federal Register on (instead of § 97.102(d) of the pre-2018
otherwise covered by paragraph (l)(3) of January 22, 2018 (83 FR 2885), as Requirements);
this section determines that such follows: (2) Section 97.103(d) of the 2018
research instead will transition to Requirements (revised certification
PART 97—PROTECTION OF HUMAN requirement that eliminates IRB review
comply with the 2018 Requirements, the
SUBJECTS of application or proposal) (instead of
institution or an IRB must document
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and date such determination. ■ 1. The authority citation for part 97 § 97.103(f) of the pre-2018
(i) If the determination to transition is continues to read as follows: Requirements); and
documented between July 19, 2018, and (3) Section 97.109(f)(1)(i) and (iii) of
January 20, 2019, the research shall: Authority: 5 U.S.C. 301; 20 U.S.C. 1221e– the 2018 Requirements (exceptions to
(A) Beginning on the date of such 3, 3474; 42 U.S.C. 300v–1(b). mandated continuing review) (instead of
documentation through January 20, ■ 2. Amend § 97.101 by adding a § 97.103(b), as related to the
2019, comply with the pre-2018 heading for paragraph (l)(1), revising requirement for continuing review, and

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in addition to § 97.109, of the pre-2018 (3) Research subject to pre-2018 (iii) Research for which a
Requirements); and requirements. The pre-2018 determination is made that the research
(B) Beginning on January 21, 2019, Requirements shall apply to the is exempt on or after January 21, 2019.
comply with the 2018 Requirements. following research, unless the research * * * * *
(ii) If the determination to transition is transitioning to comply with the 2018
is documented on or after January 21, Requirements in accordance with Jacquelyn Hayes-Byrd,
2019, the research shall, beginning on paragraph (l)(4) of this section: Acting Chief of Staff, Department of Veterans
the date of such documentation, comply (i) Research initially approved by an Affairs.
with the 2018 Requirements. IRB under the pre-2018 Requirements ENVIRONMENTAL PROTECTION
(5) Research subject to 2018 before January 21, 2019; AGENCY
Requirements. The 2018 Requirements (ii) Research for which IRB review
shall apply to the following research: was waived pursuant to § 16.101(i) of List of Subjects in 40 CFR Part 26
(i) Research initially approved by an the pre-2018 Requirements before Human research subjects, Reporting
IRB on or after January 21, 2019; January 21, 2019; and and recordkeeping requirements,
(ii) Research for which IRB review is (iii) Research for which a Research.
waived pursuant to paragraph (i) of this determination was made that the For the reasons stated in the
section on or after January 21, 2019; and research was exempt under § 16.101(b) preamble, Environmental Protection
(iii) Research for which a of the pre-2018 Requirements before Agency further amends 40 CFR part 26
determination is made that the research January 21, 2019. as published in the Federal Register on
is exempt on or after January 21, 2019. (4) Transitioning research. If, on or January 19, 2017 (82 FR 7149), and as
* * * * * after July 19, 2018, an institution amended in an interim final rule
planning or engaged in research published in the Federal Register on
Betsy DeVos,
otherwise covered by paragraph (l)(3) of January 22, 2018 (83 FR 2885), as
Secretary of Education. this section determines that such follows:
DEPARTMENT OF VETERANS research instead will transition to
AFFAIRS comply with the 2018 Requirements, the PART 26—PROTECTION OF HUMAN
institution or an IRB must document SUBJECTS
List of Subjects in 38 CFR Part 16 and date such determination.
Human research subjects, Reporting (i) If the determination to transition is ■ 1. The authority citation for part 26
and recordkeeping requirements, documented between July 19, 2018, and continues to read as follows:
Research. January 20, 2019, the research shall: Authority: 5 U.S.C. 301; 7 U.S.C. 136a(a)
For the reasons stated in the (A) Beginning on the date of such and 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); sec.
preamble, Department of Veterans documentation through January 20, 201, Pub. L. 109–54, 119 Stat. 531; and 42
Affairs further amends 38 CFR part 16 2019, comply with the pre-2018 U.S.C. 300v–1(b).
as published in the Federal Register on Requirements, except that the research ■ 2. Amend § 26.101 by adding a
January 19, 2017 (82 FR 7149), and as shall comply with the following: heading for paragraph (l)(1), revising
amended in an interim final rule (1) Section 16.102(l) of the 2018 paragraphs (l)(2), (3), and (4), and
published in the Federal Register on Requirements (definition of research) adding paragraph (l)(5) to read as
January 22, 2018 (83 FR 2885), as (instead of § 16.102(d) of the pre-2018 follows:
follows: Requirements);
(2) Section 16.103(d) of the 2018 § 26.101 To what does this policy apply?
PART 16—PROTECTION OF HUMAN Requirements (revised certification * * * * *
SUBJECTS requirement that eliminates IRB review (l) * * *
of application or proposal) (instead of (1) Pre-2018 Requirements. * * *
■ 1. The authority citation for part 16 § 16.103(f) of the pre-2018 (2) 2018 Requirements. For purposes
continues to read as follows: Requirements); and of this section, the 2018 Requirements
Authority: 5 U.S.C. 301; 38 U.S.C. 501, (3) Section 16.109(f)(1)(i) and (iii) of means the Federal Policy for the
7331, 7334; 42 U.S.C. 300v–1(b). the 2018 Requirements (exceptions to Protection of Human Subjects
■ 2. Amend § 16.101 by adding a mandated continuing review) (instead of requirements contained in this subpart.
heading for paragraph (l)(1), revising § 16.103(b), as related to the The general compliance date for the
paragraphs (l)(2), (3), and (4), and requirement for continuing review, and 2018 Requirements is January 21, 2019.
adding paragraph (l)(5) to read as in addition to § 16.109, of the pre-2018 The compliance date for § 26.114(b)
follows: Requirements); and (cooperative research) of the 2018
(B) Beginning on January 21, 2019, Requirements is January 20, 2020.
§ 16.101 To what does this policy apply? comply with the 2018 Requirements. (3) Research subject to pre-2018
* * * * * (ii) If the determination to transition requirements. The pre-2018
(l) * * * is documented on or after January 21, Requirements shall apply to the
(1) Pre-2018 Requirements. * * * 2019, the research shall, beginning on following research, unless the research
(2) 2018 Requirements. For purposes the date of such documentation, comply is transitioning to comply with the 2018
of this section, the 2018 Requirements with the 2018 Requirements. Requirements in accordance with
means the Federal Policy for the (5) Research subject to 2018 paragraph (l)(4) of this section:
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Protection of Human Subjects Requirements. The 2018 Requirements (i) Research initially approved by an
requirements contained in this part. The shall apply to the following research: IRB under the pre-2018 Requirements
general compliance date for the 2018 (i) Research initially approved by an before January 21, 2019;
Requirements is January 21, 2019. The IRB on or after January 21, 2019; (ii) Research for which IRB review
compliance date for § 16.114(b) (ii) Research for which IRB review is was waived pursuant to § 26.101(i) of
(cooperative research) of the 2018 waived pursuant to paragraph (i) of this the pre-2018 Requirements before
Requirements is January 20, 2020. section on or after January 21, 2019; and January 21, 2019; and

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28518 Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations

(iii) Research for which a For the reasons stated in the (A) Beginning on the date of such
determination was made that the preamble, Department of Health and documentation through January 20,
research was exempt under § 26.101(b) Human Services further amends 45 CFR 2019, comply with the pre-2018
of the pre-2018 Requirements before part 46 as published in the Federal Requirements, except that the research
January 21, 2019. Register on January 19, 2017 (82 FR shall comply with the following:
(4) Transitioning research. If, on or 7149), and as amended in an interim (1) Section 46.102(l) of the 2018
after July 19, 2018, an institution final rule published in the Federal Requirements (definition of research)
planning or engaged in research Register on January 22, 2018 (83 FR (instead of § 46.102(d) of the pre-2018
otherwise covered by paragraph (l)(3) of 2885), as follows: Requirements);
this section determines that such (2) Section 46.103(d) of the 2018
research instead will transition to PART 46—PROTECTION OF HUMAN Requirements (revised certification
comply with the 2018 Requirements, the SUBJECTS requirement that eliminates IRB review
institution or an IRB must document of application or proposal) (instead of
and date such determination. ■ 1. The authority citation for part 46 § 46.103(f) of the pre-2018
(i) If the determination to transition is continues to read as follows: Requirements); and
documented between July 19, 2018, and Authority: 5 U.S.C. 301; 42 U.S.C. 289(a); (3) Section 46.109(f)(1)(i) and (iii) of
January 20, 2019, the research shall: 42 U.S.C. 300v–1(b). the 2018 Requirements (exceptions to
(A) Beginning on the date of such mandated continuing review) (instead of
■ 2. Amend § 46.101 by adding a
documentation through January 20, § 46.103(b), as related to the
heading for paragraph (l)(1), revising
2019, comply with the pre-2018 requirement for continuing review, and
paragraphs (l)(2), (3), and (4), and
Requirements, except that the research in addition to § 46.109, of the pre-2018
adding paragraph (l)(5) to read as
shall comply with the following: Requirements); and
follows:
(1) Section 26.102(l) of the 2018 (B) Beginning on January 21, 2019,
Requirements (definition of research) § 46.101 To what does this policy apply? comply with the 2018 Requirements.
(instead of § 26.102(d) of the pre-2018 * * * * * (ii) If the determination to transition
Requirements); (l) * * * is documented on or after January 21,
(2) Section 26.103(d) of the 2018 (1) Pre-2018 Requirements. * * * 2019, the research shall, beginning on
Requirements (revised certification the date of such documentation, comply
(2) 2018 Requirements. For purposes
requirement that eliminates IRB review with the 2018 Requirements.
of this section, the 2018 Requirements
of application or proposal) (instead of (5) Research subject to 2018
means the Federal Policy for the
§ 26.103(f) of the pre-2018 Requirements. The 2018 Requirements
Protection of Human Subjects
Requirements); and shall apply to the following research:
requirements contained in this subpart.
(3) Section 26.109(f)(1)(i) and (iii) of
The general compliance date for the (i) Research initially approved by an
the 2018 Requirements (exceptions to
2018 Requirements is January 21, 2019. IRB on or after January 21, 2019;
mandated continuing review) (instead of
The compliance date for § 46.114(b) (ii) Research for which IRB review is
§ 26.103(b), as related to the
(cooperative research) of the 2018 waived pursuant to paragraph (i) of this
requirement for continuing review, and
Requirements is January 20, 2020. section on or after January 21, 2019; and
in addition to § 26.109, of the pre-2018
(3) Research subject to pre-2018 (iii) Research for which a
Requirements); and
(B) Beginning on January 21, 2019, requirements. The pre-2018 determination is made that the research
comply with the 2018 Requirements. Requirements shall apply to the is exempt on or after January 21, 2019.
(ii) If the determination to transition following research, unless the research * * * * *
is documented on or after January 21, is transitioning to comply with the 2018
Requirements in accordance with Alex M. Azar II,
2019, the research shall, beginning on
paragraph (l)(4) of this section: Secretary, U.S. Department of Health and
the date of such documentation, comply Human Services.
with the 2018 Requirements. (i) Research initially approved by an
(5) Research subject to 2018 IRB under the pre-2018 Requirements NATIONAL SCIENCE FOUNDATION
Requirements. The 2018 Requirements before January 21, 2019;
(ii) Research for which IRB review List of Subjects in 45 CFR Part 690
shall apply to the following research:
(i) Research initially approved by an was waived pursuant to § 46.101(i) of Human research subjects, Reporting
IRB on or after January 21, 2019; the pre-2018 Requirements before and recordkeeping requirements,
(ii) Research for which IRB review is January 21, 2019; and Research.
waived pursuant to paragraph (i) of this (iii) Research for which a For the reasons stated in the
section on or after January 21, 2019; and determination was made that the preamble, National Science Foundation
(iii) Research for which a research was exempt under § 46.101(b) further amends 45 CFR part 690 as
determination is made that the research of the pre-2018 Requirements before published in the Federal Register on
is exempt on or after January 21, 2019. January 21, 2019. January 19, 2017 (82 FR 7149), and as
* * * * * (4) Transitioning research. If, on or amended in an interim final rule
after July 19, 2018, an institution published in the Federal Register on
E. Scott Pruitt, planning or engaged in research January 22, 2018 (83 FR 2885), as
Administrator, Environmental Protection otherwise covered by paragraph (l)(3) of follows:
Agency. this section determines that such
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DEPARTMENT OF HEALTH AND research instead will transition to PART 690—PROTECTION OF HUMAN
HUMAN SERVICES comply with the 2018 Requirements, the SUBJECTS
institution or an IRB must document
List of Subjects in 45 CFR Part 46 and date such determination. ■ 1. The authority citation for part 690
Human research subjects, Reporting (i) If the determination to transition is continues to read as follows:
and recordkeeping requirements, documented between July 19, 2018, and Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
Research. January 20, 2019, the research shall: 1(b).

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Federal Register / Vol. 83, No. 118 / Tuesday, June 19, 2018 / Rules and Regulations 28519

■ 2. Amend § 690.101 by adding a § 690.103(b), as related to the (cooperative research) of the 2018
heading for paragraph (l)(1), revising requirement for continuing review, and Requirements is January 20, 2020.
paragraphs (l)(2), (3), and (4), and in addition to § 690.109, of the pre-2018 (3) Research subject to pre-2018
adding paragraph (l)(5) to read as Requirements); and requirements. The pre-2018
follows: (B) Beginning on January 21, 2019, Requirements shall apply to the
comply with the 2018 Requirements. following research, unless the research
§ 690.101 To what does this policy apply? (ii) If the determination to transition is transitioning to comply with the 2018
* * * * * is documented on or after January 21, Requirements in accordance with
(l) * * * 2019, the research shall, beginning on paragraph (l)(4) of this section:
(1) Pre-2018 Requirements. * * * the date of such documentation, comply (i) Research initially approved by an
(2) 2018 Requirements. For purposes with the 2018 Requirements. IRB under the pre-2018 Requirements
of this section, the 2018 Requirements (5) Research subject to 2018 before January 21, 2019;
means the Federal Policy for the Requirements. The 2018 Requirements
Protection of Human Subjects (ii) Research for which IRB review
shall apply to the following research: was waived pursuant to § 11.101(i) of
requirements contained in this part. The (i) Research initially approved by an
general compliance date for the 2018 the pre-2018 Requirements before
IRB on or after January 21, 2019; January 21, 2019; and
Requirements is January 21, 2019. The (ii) Research for which IRB review is
compliance date for § 690.114(b) (iii) Research for which a
waived pursuant to paragraph (i) of this determination was made that the
(cooperative research) of the 2018 section on or after January 21, 2019; and
Requirements is January 20, 2020. research was exempt under § 11.101(b)
(iii) Research for which a of the pre-2018 Requirements before
(3) Research subject to pre-2018 determination is made that the research
requirements. The pre-2018 January 21, 2019.
is exempt on or after January 21, 2019.
Requirements shall apply to the (4) Transitioning research. If, on or
* * * * * after July 19, 2018, an institution
following research, unless the research
is transitioning to comply with the 2018 Lawrence Rudolph, planning or engaged in research
Requirements in accordance with General Counsel, National Science otherwise covered by paragraph (l)(3) of
paragraph (l)(4) of this section: Foundation. this section determines that such
(i) Research initially approved by an research instead will transition to
IRB under the pre-2018 Requirements DEPARTMENT OF TRANSPORTATION comply with the 2018 Requirements, the
before January 21, 2019; List of Subjects in 49 CFR Part 11 institution or an IRB must document
(ii) Research for which IRB review and date such determination.
Human research subjects, Reporting
was waived pursuant to § 690.101(i) of (i) If the determination to transition is
and recordkeeping requirements,
the pre-2018 Requirements before documented between July 19, 2018, and
Research.
January 21, 2019; and January 20, 2019, the research shall:
(iii) Research for which a For the reasons stated in the (A) Beginning on the date of such
determination was made that the preamble, Department of Transportation documentation through January 20,
research was exempt under § 690.101(b) further amends 49 CFR part 11 as 2019, comply with the pre-2018
of the pre-2018 Requirements before published in the Federal Register on Requirements, except that the research
January 21, 2019. January 19, 2017 (82 FR 7149), and as shall comply with the following:
(4) Transitioning research. If, on or amended in an interim final rule
(1) Section 11.102(l) of the 2018
after July 19, 2018, an institution published in the Federal Register on
Requirements (definition of research)
planning or engaged in research January 22, 2018 (83 FR 2885), as
(instead of § 11.102(d) of the pre-2018
otherwise covered by paragraph (l)(3) of follows:
Requirements);
this section determines that such (2) Section 11.103(d) of the 2018
research instead will transition to PART 11—PROTECTION OF HUMAN
SUBJECTS Requirements (revised certification
comply with the 2018 Requirements, the requirement that eliminates IRB review
institution or an IRB must document ■ 1. The authority citation for part 11 of application or proposal) (instead of
and date such determination. continues to read as follows: § 11.103(f) of the pre-2018
(i) If the determination to transition is Requirements); and
documented between July 19, 2018, and Authority: 5 U.S.C. 301; 42 U.S.C. 300v–
1(b). (3) Section 11.109(f)(1)(i) and (iii) of
January 20, 2019, the research shall:
(A) Beginning on the date of such the 2018 Requirements (exceptions to
■ 2. Amend § 11.101 by adding a
documentation through January 20, mandated continuing review) (instead of
heading for paragraph (l)(1), revising
2019, comply with the pre-2018 § 11.103(b), as related to the
paragraphs (l)(2), (3), and (4), and
Requirements, except that the research requirement for continuing review, and
adding paragraph (l)(5) to read as
shall comply with the following: in addition to § 11.109, of the pre-2018
follows:
(1) Section 690.102(l) of the 2018 Requirements); and
Requirements (definition of research) § 11.101 To what does this policy apply? (B) Beginning on January 21, 2019,
(instead of § 690.102(d) of the pre-2018 * * * * * comply with the 2018 Requirements.
Requirements); (l) * * * (ii) If the determination to transition
(2) Section 690.103(d) of the 2018 (1) Pre-2018 Requirements. * * * is documented on or after January 21,
Requirements (revised certification (2) 2018 Requirements. For purposes 2019, the research shall, beginning on
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requirement that eliminates IRB review of this section, the 2018 Requirements the date of such documentation, comply
of application or proposal) (instead of means the Federal Policy for the with the 2018 Requirements.
§ 690.103(f) of the pre-2018 Protection of Human Subjects (5) Research subject to 2018
Requirements); and requirements contained in this part. The Requirements. The 2018 Requirements
(3) Section 690.109(f)(1)(i) and (iii) of general compliance date for the 2018 shall apply to the following research:
the 2018 Requirements (exceptions to Requirements is January 21, 2019. The (i) Research initially approved by an
mandated continuing review) (instead of compliance date for § 11.114(b) IRB on or after January 21, 2019;

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(ii) Research for which IRB review is (iii) Research for which a
waived pursuant to paragraph (i) of this determination is made that the research
section on or after January 21, 2019; and is exempt on or after January 21, 2019.
* * * * *
Elaine L. Chao,
Secretary of Transportation.
[FR Doc. 2018–13187 Filed 6–18–18; 8:45 am]
BILLING CODE 4150–36–P
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