Guidance on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability, 65538-65539 [E9-29286]

Download as PDF 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 https:// www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. mstockstill on DSKH9S0YB1PROD with NOTICES 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: Brenda.Uratani@fda.hhs.gov. SUPPLEMENTARY INFORMATION: VerDate Nov<24>2008 17:19 Dec 09, 2009 Jkt 220001 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 https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 E:\FR\FM\10DEN1.SGM 10DEN1 Federal Register / Vol. 74, No. 236 / Thursday, December 10, 2009 / Notices Guidances/default.htm or https://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, hanspalm@csr.nih.gov. 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, David.Weinberg@nih.gov. Name of Committee: Oncology 2— Translational Clinical Integrated Review Group; Cancer Immunopathology and Immunotherapy Study Section. Date: January 21–22, 2010. VerDate Nov<24>2008 17:19 Dec 09, 2009 Jkt 220001 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, shawdeni@csr.nih.gov. 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, sizemoren@csr.nih.gov. 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, riverase@csr.nih.gov. 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, lijames@csr.nih.gov. 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, faradaym@csr.nih.gov. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 65539 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, gubanics@csr.nih.gov. 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, bsokolov@csr.nih.gov. (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. E:\FR\FM\10DEN1.SGM 10DEN1

Agencies

[Federal Register Volume 74, Number 236 (Thursday, December 10, 2009)]
[Notices]
[Pages 65538-65539]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-29286]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

SUMMARY: 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.

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

ADDRESSES: 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 https://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for 
electronic access to the guidance document.

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: 
Brenda.Uratani@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

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.

II. The Guidance

    The guidance entitled ``PET Drugs--Current Good Manufacturing 
Practice (CGMP)'' provides recommended approaches for complying with 
the 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.

V. Electronic Access

    Persons with access to the Internet may obtain the document at 
either https://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/

[[Page 65539]]

Guidances/default.htm or https://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
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