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Federal Register / Vol. 73, No.

53 / Tuesday, March 18, 2008 / Notices 14471

Dated: March 12, 2008. DEPARTMENT OF HEALTH AND provide information to a third party.
Diane Allen, HUMAN SERVICES Section 3506(c)(2)(A) of the PRA (44
Acting Director, Management Analysis and U.S.C. 3506(c)(2)(A)) requires Federal
Services Office, Centers for Disease Control Food and Drug Administration agencies to provide a 60-day notice in
and Prevention. [Docket No. FDA–2008–N–0162] the Federal Register concerning each
[FR Doc. E8–5376 Filed 3–17–08; 8:45 am] proposed collection of information,
Agency Information Collection including each proposed extension of an
BILLING CODE 4163–18–P
Activities; Proposed Collection; existing collection of information,
Comment Request; Prescription Drug before submitting the collection to OMB
DEPARTMENT OF HEALTH AND Product Labeling: Medication Guide for approval. To comply with this
Requirements requirement, FDA is publishing notice
HUMAN SERVICES
of the proposed collection of
AGENCY: Food and Drug Administration, information set forth in this document.
Food and Drug Administration HHS. With respect to the following
ACTION: Notice. collection of information, FDA invites
[Docket No. FDA–2008–N–0157 (formerly comments on these topics: (1) Whether
2007N–0105)] SUMMARY: The Food and Drug the proposed collection of information
Administration (FDA) is announcing an is necessary for the proper performance
Agency Information Collection opportunity for public comment on the of FDA’s functions, including whether
Activities; Announcement of Office of proposed collection of certain the information will have practical
Management and Budget Approval; information by the agency. Under the utility; (2) the accuracy of FDA’s
Mental Models Study of Food Paperwork Reduction Act of 1995 (the estimate of the burden of the proposed
Terrorism Risk Awareness PRA), Federal agencies are required to collection of information, including the
publish notice in the Federal Register validity of the methodology and
AGENCY: Food and Drug Administration, concerning each proposed collection of assumption used; (3) ways to enhance
HHS. information, including each proposed the quality, utility, and clarity of the
extension of an existing collection of information to be collected; and (4)
ACTION: Notice.
information, and to allow 60 days for ways to minimize the burden of the
public comment in response to the collection of information on
SUMMARY: The Food and Drug
notice. This notice solicits comments on respondents, including through the use
Administration (FDA) is announcing regulations requiring the distribution of of automated collection techniques,
that a collection of information entitled patient labeling, called Medications when appropriate, and other forms of
‘‘Mental Models Study of Food Guides, for certain products that pose a information technology.
Terrorism Risk Awareness’’ has been serious and significant public health
approved by the Office of Management concern requiring distribution of FDA- Prescription Drug Product Labeling:
and Budget (OMB) under the Paperwork approved patient medication. Medication Guide Requirements (OMB
Reduction Act of 1995. Control Number 0910–0393)—Extension
DATES: Submit written or electronic
FOR FURTHER INFORMATION CONTACT: comments on the collection of FDA regulations require the
information by May 19, 2008. distribution of patient labeling, called
Jonna Capezzuto, Office of the Chief
ADDRESSES: Submit electronic Medication Guides, for certain
Information Officer (HFA–250), Food
comments on the collection of prescription human drug and biological
and Drug Administration, 5600 Fishers
information to http:// products used primarily on an
Lane, Rockville, MD 20857, 301–827– outpatient basis that pose a serious and
4659. www.regulations.gov. Submit written
comments on the collection of significant public health concern
SUPPLEMENTARY INFORMATION: In the information to Division of Dockets requiring distribution of FDA-approved
Federal Register of July 24, 2007 (72 FR Management (HFA–305), Food and Drug patient medication information. These
40309), the agency announced that the Administration, 5630 Fishers Lane, rm. Medication Guides inform patients
proposed information collection had 1061, Rockville, MD 20852. All about the most important information
been submitted to OMB for review and comments should be identified with the they should know about these products
docket number found in brackets in the in order to use them safely and
clearance under 44 U.S.C. 3507. An
heading of this document. effectively. Included is information such
agency may not conduct or sponsor, and
as the drug’s approved uses,
a person is not required to respond to, FOR FURTHER INFORMATION CONTACT:
contraindications, adverse drug
a collection of information unless it Elizabeth Berbakos, Office of the Chief
reactions, and cautions for specific
displays a currently valid OMB control Information Officer (HFA–250), Food
populations, with a focus on why the
number. OMB has now approved the and Drug Administration, 5600 Fishers
particular product requires a Medication
information collection and has assigned Lane, Rockville, MD 20857, 301–827–
Guide. These regulations are intended to
OMB control number 0910–0618. The 1482.
improve the public health by providing
approval expires on February 28, 2011. SUPPLEMENTARY INFORMATION: Under the information necessary for patients to use
A copy of the supporting statement for PRA (44 U.S.C. 3501–3520), Federal certain medications safely and
this information collection is available agencies must obtain approval from the effectively.
on the Internet at http:// Office of Management and Budget The regulations contain the following
www.reginfo.gov/public/do/PRAMain. (OMB) for each collection of reporting requirements that are subject
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Dated: March 10, 2008. information they conduct or sponsor. to the PRA. The estimates for the burden
‘‘Collection of information’’ is defined hours imposed by the following
Jeffrey Shuren,
in 44 U.S.C. 3502(3) and 5 CFR regulations are listed in table 1 of this
Assistant Commissioner for Policy. 1320.3(c) and includes agency requests document:
[FR Doc. E8–5361 Filed 3–17–08; 8:45 am] or requirements that members of the • 21 CFR 208.20—Applicants must
BILLING CODE 4160–01–S public submit reports, keep records, or submit draft Medication Guides for FDA

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14472 Federal Register / Vol. 73, No. 53 / Tuesday, March 18, 2008 / Notices

approval according to the prescribed provide a Medication Guide directly to • 21 CFR 314.70(b)(3)(ii) and 21 CFR
content and format. each patient unless an exemption 601.12(f)—Application holders must
• 21 CFR 208.24(e)—Each authorized applies under § 208.26 (21 CFR 208.26). submit changes to Medication Guides to
dispenser of a prescription drug product • Section 208.26(a)—Requests may be FDA for prior approval as supplements
for which a Medication Guide is submitted for exemption or deferral to their applications.
required, when dispensing the product from particular Medication Guide FDA estimates the burden of this
to a patient or to a patient’s agent, must content or format requirements. collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1


No. of Annual Frequency Total Annual Hours Per
21 CFR Section Total Hours
Respondents per Response Responses Response

208.20 10 1 10 320 3,200

208.24(e) 59,000 5,000 295 million .0014 413,000

208.26(a) 1 1 1 4 4

314.70(b)(3)(ii) and 601.12(f) 5 1 5 72 360

Total 416,564

Please note that on January 15, 2008, SUPPLEMENTARY INFORMATION: In FR Doc. is limited and pre-registration is
the FDA Division of Dockets E8–316, published on January 11, 2008 encouraged (see below).
Management Web site transitioned to (73 FR 2055), the following correction is SUPPLEMENTARY INFORMATION: Under the
the Federal Dockets Management made: authority of 42 U.S.C. Section 217a,
System (FDMS). FDMS is a On page 2055, in the second column, Section 222 of the Public Health Service
Government-wide, electronic docket in the SUMMARY and SUPPLEMENTARY Act, as amended, and 42 CFR 121.12
management system. Electronic INFORMATION sections, ‘‘Oyi’’ is corrected (2000), ACOT was established to assist
comments or submissions will be to read ‘‘Oyj’’. the Secretary in enhancing organ
accepted by FDA through FDMS only. donation, ensuring that the system of
Dated: March 7, 2008.
Dated: March 11, 2008. organ transplantation is grounded in the
Bernadette Dunham, best available medical science, and
Jeffrey Shuren,
Director, Center for Veterinary Medicine. assuring the public that the system is as
Assistant Commissioner for Policy.
[FR Doc. E8–5453 Filed 3–17–08; 8:45 am] effective and equitable as possible, and,
[FR Doc. E8–5384 Filed 3–17–08; 8:45 am]
BILLING CODE 4160–01–S thereby, increasing public confidence in
BILLING CODE 4160–01–S
the integrity and effectiveness of the
transplantation system. ACOT is
DEPARTMENT OF HEALTH AND composed of up to 25 members,
DEPARTMENT OF HEALTH AND HUMAN SERVICES
HUMAN SERVICES including the Chair. Members are
serving as Special Government
Health Resources and Services Employees and have diverse
Food and Drug Administration
Administration backgrounds in fields such as organ
[Docket No. 2007F–0478] donation, health care public policy,
Meeting of the Advisory Committee on
Kemira Oyj; Filing of Food Additive transplantation medicine and surgery,
Organ Transplantation
Petition (Animal Use); Partially critical care medicine and other medical
Ammoniated Formic Acid; Correction AGENCY:Health Resources and Services specialties involved in the identification
Administration, HHS. and referral of donors, non-physician
AGENCY: Food and Drug Administration, transplant professions, nursing,
HHS. ACTION:Notice of Meeting of the epidemiology, immunology, law and
ACTION: Notice; correction. Advisory Committee on Organ bioethics, behavioral sciences,
Transplantation. economics and statistics, as well as
SUMMARY: The Food and Drug representatives of transplant candidates,
Administration (FDA) is correcting a SUMMARY: Pursuant to Public Law 92– transplant recipients, organ donors, and
document announcing the filing of a 463, the Federal Advisory Committee family members.
food additive petition that appeared in Act, as amended (5 U.S.C. Appendix 2), ACOT will hear presentations on the
the Federal Register of January 11, notice is hereby given of the fourteenth ‘‘Kidney Disease Outcome Quality
2008. FDA is correcting the name of the meeting of the Advisory Committee on Initiative/Early Kidney Transplantation
petitioner which was misspelled during Organ Transplantation (ACOT), Conference’’ held on March 19–20,
document drafting. Department of Health and Human 2007; adolescent/medication
DATES: This correction is effective Services (HHS). The meeting will be nonadherence/transitioning from
March 18, 2008. held from approximately 9 a.m. to 5:30 pediatric-adolescent care to adult care;
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FOR FURTHER INFORMATION CONTACT: p.m. on May 5, 2008, and from 9 a.m. revised informed consent
George K. Haibel, Center for Veterinary to 3 p.m. on May 6, 2008, at the Hilton recommendation; recovery/allocation/
Medicine (HFV–6), Food and Drug Washington D.C./Rockville Executive transplantation practices outside the
Administration, 7519 Standish Pl., Meeting Center, 1750 Rockville Pike, United States; and a final report on the
Rockville, MD 20855, 240–267–9019, e- Rockville, MD 20852. The meeting will economics of transplantation. The four
mail: george.haibel@fda.hhs.gov. be open to the public; however, seating ACOT work groups also will update the

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