
[Federal Register: December 10, 2009 (Volume 74, Number 236)]
[Notices]               
[Page 65538-65539]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10de09-70]                         

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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.

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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 http://
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 http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/

[[Page 65539]]

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
