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65038 Federal Register / Vol. 72, No.

222 / Monday, November 19, 2007 / Notices

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


Annual Fre-
No. of Total Annual Hours per
21 CFR Section quency Total Hours
Respondents Responses Response
per Response

740(d)(1)(A) Significant barrier to inno- 5 1 time for each 5 2 10


vation application

740(d)(1)(B) Fees exceed cost 1 do. 1 2 2

740(d)(1)(C) Free choice feeds 5 do. 5 2 10

740(d)(1)(D) Minor use or minor spe- 10 do. 10 2 20


cies

740(d)(1)(E) Small business 2 do. 2 2 4

Request for reconsideration of a deci- 5 do. 5 2 10


sion

Request for review—(user fee appeal 2 do. 2 2 4


officer)

Total 60
1There are no capital costs or operating and maintenance costs associated with this collection of information.

Based on FDA’s database system, DEPARTMENT OF HEALTH AND Information Officer (HFA–250), Food
there are an estimated 250 sponsors of HUMAN SERVICES and Drug Administration, 5600 Fishers
products subject to ADUFA. However, Lane, Rockville, MD 20857, 301–827–
not all sponsors will have any Food and Drug Administration 1472.
submissions in a given year and some [Docket No 2007N–0227] SUPPLEMENTARY INFORMATION: In
may have multiple submissions. The compliance with 44 U.S.C. 3507, FDA
total number of waiver requests is based Agency Information Collection has submitted the following proposed
on the number of submission types Activities: Submission for Office of collection of information to OMB for
received by FDA in fiscal year 2003. Management and Budget Review; review and clearance.
FDA’s Center for Veterinary Medicine Comment Request; Medical Devices
Third-Party Review Under the Food Medical Devices Third-Party Review
estimates 30 waiver requests that Under the Food and Drug
include the following: 5 significant and Drug Administration
Modernization Act Administration Modernization Act;
barriers to innovation, 1 fee exceed cost, Section 523 of the Federal Food, Drug,
5 free choice feeds, 10 minor use or AGENCY: Food and Drug Administration, and Cosmetic Act (OMB Control
minor species, 2 small business waiver HHS. Number 0910–0375)—Extension
requests, 5 requests for reconsideration ACTION: Notice. Section 210 of the Food and Drug
of a decision, and 2 requests for user fee Administration Modernization Act
appeal officer. The estimated hours per SUMMARY: The Food and Drug
Administration (FDA) is announcing (FDAMA) established section 523 of the
response are based on past FDA Federal Food, Drug, and Cosmetic Act
experience with the various waiver that a proposed collection of
information has been submitted to the (the act) (21 U.S.C. 360m), directing
requests in FDA’s Center for Drug FDA to accredit persons in the private
Office of Management and Budget
Evaluation and Research. The hours per sector to review certain premarket
(OMB) for review and clearance under
response are based on the average of the Paperwork Reduction Act of 1995. applications and notifications.
these estimates. Participation in this third-party review
DATES: Fax written comments on the
Dated: November 13, 2007. program by accredited persons is
collection of information by December
entirely voluntary. A third party
Jeffrey Shuren, 19, 2007.
wishing to participate will submit a
Assistant Commissioner for Policy. ADDRESSES: To ensure that comments on request for accreditation to FDA.
[FR Doc. E7–22495 Filed 11–16–07; 8:45 am] the information collection are received, Accredited third-party reviewers have
BILLING CODE 4160–01–S
OMB recommends that written the ability to review a manufacturer’s
comments be faxed to the Office of 510(k) submission for selected devices.
Information and Regulatory Affairs, After reviewing a submission, the
OMB, Attn: FDA Desk Officer, FAX: reviewer will forward a copy of the
202–395–6974, or e-mailed to 510(k) submission, along with the
baguilar@omb.eop.gov. All comments reviewer’s documented review and
should be identified with the OMB recommendation to FDA. Third-party
control number 0910–0375. Also reviewers should maintain records of
rwilkins on PROD1PC63 with NOTICES

include the FDA docket number found their 510(k) reviews and a copy of the
in brackets in the heading of this 510(k) for a reasonable period of time,
document. usually a period of 3 years. This
FOR FURTHER INFORMATION CONTACT: information collection will allow FDA
Denver Presley, Jr, Office of the Chief to continue to implement the accredited

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Federal Register / Vol. 72, No. 222 / Monday, November 19, 2007 / Notices 65039

person review program established by In the Federal Register of June 21, Respondents to this information
FDAMA and improve the efficiency of 2007 (72 FR 34257), FDA published a collection are businesses or other for-
510(k) review for low to moderate risk 60-day notice requesting public profit organizations.
devices. comment on the information collection FDA estimates the burden of this
provisions. No comments were received. collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of Annual Frequency Total Annual Hours per
Section 523 of the act Total Hours
Respondents per Response Responses Response

Requests for accreditation 1 1 1 24 24

510(k) reviews conducted by accredited


third parties 14 24 336 40 13,440

Total 13,464
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1


No. of Annual Frequency Total Annual Hours per
Section 523 of the act Total Hours
Recordkeepers per Record Records Recordkeeper

510(k) reviews by third-party reviewers 14 24 336 10 3,600


1 There are no capital costs or operating and maintenance costs associated with this collection of information.

I. Reporting DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT:


HUMAN SERVICES Denver Presley Jr., Office of the Chief
A. Requests for Accreditation
Information Officer (HFA–250), Food
FDA now has approximately 8 years Food and Drug Administration and Drug Administration, 5600 Fishers
of experience with third-party reviews Lane, Rockville, MD 20857, 301–827–
under section 523 of the act. Currently [Docket No. 2007N–0305] 1472.
there are 11 active accredited third
SUPPLEMENTARY INFORMATION: In
parties. FDA does not expect to receive Agency Information Collection
compliance with 44 U.S.C. 3507, FDA
more than 1 application for Activities; Submission for Office of
has submitted the following proposed
accreditation per year for a total of 14 Management and Budget Review;
collection of information to OMB for
accredited third parties who will be Comment Request; Current Good
review and clearance.
conducting third-party reviews. Manufacturing Practice Regulations for
Medicated Feeds Current Good Manufacturing Practice
B. 510(k) Reviews Conducted by
Regulations for Medicated Feeds—21
Accredited Third Parties AGENCY: Food and Drug Administration, CFR Part 225 (OMB Control Number
FDA has received 784 510(k) HHS. 0910–0152)—Extension
submissions with a third-party review ACTION: Notice.
since 2004. FDA estimates that over the Under section 501 of the Federal
next 3 years, they will accredit 1 third- SUMMARY: The Food and Drug
Food, Drug, and Cosmetic Act (the act)
party reviewer per year for a total of 14 Administration (FDA) is announcing (21 U.S.C. 351), FDA has the statutory
third parties. Each third-party reviewer that a proposed collection of authority to issue current good
expects to review a total of 24 510(k) information has been submitted to the manufacturing practice (cGMP)
submissions per year for an annual total Office of Management and Budget regulations for drugs, including
of 336 applications. (OMB) for review and clearance under medicated feeds. Medicated feeds are
the Paperwork Reduction Act of 1995. administered to animals for the
II. Recordkeeping prevention, cure, mitigation, or
DATES: Fax written comments on the treatment of disease, or growth
Third-party reviewers are required to collection of information by December
keep records of their review of each promotion and feed efficiency. Statutory
19, 2007. requirements for cGMPs have been
submission. At the end of 3 years, the
agency expects to have 14 accredited ADDRESSES: To ensure that comments on codified under part 225 (21 CFR part
persons for review with each third party the information collection are received, 225). Medicated feeds that are not
reviewing on average 24 510(k) OMB recommends that written manufactured in accordance with these
applications per year. The agency comments be faxed to the Office of regulations are considered adulterated
anticipates approximately 336 510(k) Information and Regulatory Affairs, under section 501(a)(2)(B) of the act.
annual submissions for third-party OMB, Attn: FDA Desk Officer, FAX: Under part 225, a manufacturer is
review. 202–395–6974, or e-mailed to required to establish, maintain, and
baguilar@omb.eop.gov. All comments retain records for a medicated feed,
rwilkins on PROD1PC63 with NOTICES

Dated: November 14, 2007. should be identified with the OMB including records to document
Jeffrey Shuren, control number 0910–0152. Also procedures required during the
Assistant Commissioner for Policy. include the FDA docket number found manufacturing process to assure that
[FR Doc. E7–22586 Filed 11–16–07; 8:45 am] in brackets in the heading of this proper quality control is maintained.
BILLING CODE 4160–01–S document. Such records would, for example,

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