Final Guidance

65538

Federal Register / Vol. 74, No. 236 / Thursday, December 10, 2009 / Notices

Dated: December 3, 2009.
Maryam I. Daneshvar,
Acting Reports Clearance Officer, Centers for
Disease Control and Prevention.
[FR Doc. E9–29445 Filed 12–9–09; 8:45 am]
BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–1998–D–0025] (formerly
Docket No. 1998D–0266)

Guidance on Current Good
Manufacturing Practice for Positron
Emission Tomography Drugs;
Availability
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing the
availability of a guidance entitled ‘‘PET
Drugs—Current Good Manufacturing
Practice (CGMP).’’ Elsewhere in this
issue of the Federal Register, we are
issuing final regulations on CGMPs for
positron emission tomography (PET)
drugs. We are issuing the guidance to
help PET drug producers better
understand FDA’s thinking concerning
compliance with the PET CGMP
regulations.
SUMMARY:

DATES: Submit written or electronic
comments on agency guidances at any
time.

Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. Submit written comments on
the guidance to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. Submit
electronic comments to http://
www.regulations.gov. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the guidance
document.
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ADDRESSES:

FOR FURTHER INFORMATION CONTACT:
Brenda Uratani, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD
20993–0002, 1–240–328–7621, e-mail:
[email protected].
SUPPLEMENTARY INFORMATION:

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I. Background
On November 21, 1997, the President
signed the Food and Drug
Administration Modernization Act of
1997 (Modernization Act) (Public Law
105–115) into law. Section 121(c)(1)(A)
of the Modernization Act directs us to
establish appropriate approval
procedures and CGMP requirements for
PET drugs. Section 121(c)(1)(B) states
that, in adopting such requirements, we
must take due account of any relevant
differences between not-for-profit
institutions that compound PET drugs
for their patients and commercial
manufacturers of the drugs. Section
121(c)(1)(B) also directs us to consult
with patient advocacy groups,
professional associations,
manufacturers, and physicians and
scientists who make or use PET drugs as
we develop PET drug CGMP
requirements and approval procedures.
In accordance with section 121 of the
Modernization Act, we have taken the
following actions in developing the
regulations on CGMP for PET drugs:
• Regulations. We made available
preliminary draft regulations (64 FR
51274, September 22, 1999), and a
preliminary draft proposed rule (67 FR
15344, April 1, 2002), and published a
proposed rule on PET drug CGMP (70
FR 55038, September 20, 2005).
• Public Meetings. We held public
meetings on February 19, 1999,
September 28, 1999, and May 21, 2002,
to discuss our tentative approach,
preliminary draft regulations, and
preliminary draft proposed rule. We
responded to numerous questions and
comments and made changes in our
preliminary draft regulations and
proposed rule in response to written
and oral comments.
• Guidance. When we published the
preliminary draft proposed rule, we
published a draft guidance on CGMP for
PET drugs (67 FR 15404, April 1, 2002).
With the proposed rule, we published a
revised draft guidance (70 FR 55145,
September 20, 2005).
Elsewhere in this issue of the Federal
Register, we are publishing a final rule
on CGMP for PET drugs. We are making
this guidance available so that PET drug
producers can better understand our
thinking on compliance with the PET
CGMP regulations, including
appropriate resources, procedures, and
documentation for PET drug production
facilities.

regulations on CGMP for PET drugs. In
preparing the guidance, we considered
all comments received on the revised
draft guidance of the same name. The
guidance includes revisions to coincide
with the final rule on PET CGMP and
clarifications in response to comments
on the revised draft guidance.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the agency’s
current thinking on compliance with
CGMP for PET drugs. It does not create
or confer any rights for or on any person
and does not operate to bind FDA or the
public. An alternative approach may be
used if such approach satisfies the
requirements of the applicable statutes
and regulations.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) written or electronic
comments regarding this document.
Submit a single copy of electronic or
two paper copies of any mailed
comments, except that individuals may
submit one paper copy. Comments are
to be identified with the docket number
found in brackets in the heading of this
document. Received comments may be
seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
IV. Paperwork Reduction Act of 1995
The information collection resulting
from this guidance is covered by the
information collection provisions of the
final rule entitled ‘‘Current Good
Manufacturing Practice for Positron
Emission Tomography Drugs’’ which is
published elsewhere in this issue of the
Federal Register. The information
collection provisions of the final rule
have been submitted to the Office of
Management and Budget (OMB) for
review, as required under section
3507(d) of the Paperwork Reduction
Act. Prior to the effective date of the
final rule, FDA will publish a notice in
the Federal Register announcing OMB’s
decision to approve, modify, or
disapprove the information collection
provisions in the final rule. An agency
may not conduct or sponsor, and a
person is not required to respond to, a
collection of information unless it
displays a currently valid OMB control
number.

II. The Guidance

V. Electronic Access

The guidance entitled ‘‘PET Drugs—
Current Good Manufacturing Practice
(CGMP)’’ provides recommended
approaches for complying with the

Persons with access to the Internet
may obtain the document at either
http://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/

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Federal Register / Vol. 74, No. 236 / Thursday, December 10, 2009 / Notices
Guidances/default.htm or http://www.
regulations.gov.
Dated: December 3, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–29286 Filed 12–9–09; 8:45 am]
BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings

mstockstill on DSKH9S0YB1PROD with NOTICES

Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflicts: Vascular Pathobiology.
Date: January 5, 2010.
Time: 3 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Manjit Hanspal, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4138,
MSC 7804, Bethesda, MD 20892, 301–435–
1195, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Regulating Energy Homeostasis and
Metabolism.
Date: January 13–14, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892
(Virtual Meeting).
Contact Person: David Weinberg, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6170,
MSC 7892, Bethesda, MD 20892, 301–435–
1044, [email protected].
Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Cancer Immunopathology and
Immunotherapy Study Section.
Date: January 21–22, 2010.

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Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Nikko, 222 Mason Street, San
Francisco, CA 94102.
Contact Person: Denise R. Shaw, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6158,
MSC 7804, Bethesda, MD 20892, 301–435–
0198, [email protected].
Name of Committee: Oncology 1–Basic
Translational Integrated Review Group;
Molecular Oncogenesis Study Section.
Date: January 25–26, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Washington on
Capitol Hill, 400 New Jersey Avenue, NW.,
Washington, DC 20001.
Contact Person: Nywana Sizemore, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6204,
MSC 7804, Bethesda, MD 20892, 301–435–
1718, [email protected].
Name of Committee: Oncology 1–Basic
Translational Integrated Review Group;
Cancer Molecular Pathobiology Study
Section.
Date: January 25–26, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Doubletree Hotel Washington, DC,
1515 Rhode Island Avenue, NW.,
Washington, DC 20005.
Contact Person: Elaine Sierra-Rivera, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6184,
MSC 7804, Bethesda, MD 20892, 301–435–
1779, [email protected].
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Roadmap
HTS Assay Development.
Date: January 28–29, 2010.
Time: 8 a.m. to 3 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: James J. Li, PhD, Scientific
Review Officer, Center for Scientific Review,
National Institutes of Health, 6701 Rockledge
Drive, Room 5148, MSC 7849, Bethesda, MD
20892, 301–806–8065, [email protected].
Name of Committee: Risk, Prevention and
Health Behavior Integrated Review Group;
Psychosocial Risk and Disease Prevention
Study Section.
Date: January 28–29, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Monaco, 501 Geary Street, San
Francisco, CA 94102.
Contact Person: Martha Faraday, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3110,
MSC 7808, Bethesda, MD 20892, 301–435–
3575, [email protected].

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Name of Committee: Oncology 2—
Translational Clinical Integrated Review
Group; Developmental Therapeutics Study
Section.
Date: January 28–29, 2010.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Westin Hotel, 400 West
Broadway, San Diego, CA 92101.
Contact Person: Sharon K. Gubanich, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6214,
MSC 7804, Bethesda, MD 20892, (301) 408–
9512, [email protected].
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Cell Death in Neurodegeneration
Study Section.
Date: January 28–29, 2010.
Time: 8:30 a.m. to 6 p.m.
Agenda: To review and evaluate grant
applications.
Place: The Fairmont Washington, DC, 2401
M Street, NW., Washington, DC 20037.
Contact Person: Boris P. Sokolov, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892, 301–408–
9115, [email protected].
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: December 3, 2009.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E9–29486 Filed 12–9–09; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.

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