Document ID: FDA-2011-D-0541-0001
Agency: fda
Document Type: Notice
Title: Guidance for Small Business Entities on Current Good Manufacturing Practice for Positron Emission Tomography Drugs; Availability
Posted Date: 2011-08-05T04:00Z

[Federal Register Volume 76, Number 151 (Friday, August 5, 2011)]
[Notices]
[Pages 47593-47594]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19867]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0541]

Guidance for Small Business Entities 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 for small business entities entitled ``PET 
Drugs--Current Good Manufacturing Practice (CGMP); Small Entity 
Compliance Guide.'' FDA has prepared this guidance in accordance with 
the Small Business Regulatory Enforcement Fairness Act. It is intended 
to help small businesses better understand FDA's thinking on compliance 
with the positron emission tomography drugs (PET) CGMP regulations, 
including appropriate resources, procedures, and documentation for PET 
drug production facilities.

DATES: Submit either electronic or written 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

[[Page 47594]]

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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Frank Perrella, Center for Drug 
Evaluation and Research (HFD-320), Food and Drug Administration, 10903 
New Hampshire Ave., Silver Spring, MD 20993, 301-796-3265.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled ``PET 
Drugs--Current Good Manufacturing Practice (CGMP); Small Entity 
Compliance Guide.'' This guidance is intended to help small businesses 
better understand and comply with the regulations issued by FDA 
concerning CGMP for PET drugs. The guidance addresses resources, 
procedures, and documentation for all PET drug production facilities. 
In some cases, the guidance provides practical examples of methods or 
procedures that PET drug production facilities can use to comply with 
the CGMP requirements. FDA has prepared this guidance in accordance 
with section 212 of the Small Business Regulatory Enforcement Fairness 
Act.
    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.

II. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) either electronic or written comments regarding this 
document. It is only necessary to send one set of comments. It is no 
longer necessary to send two copies of mailed comments. Identify 
comments 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.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 211 have been approved under 
OMB control number 0910-0139, and the collections of information in 21 
CFR part 212 have been approved under OMB control number 0910-0667.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at 
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: August 1, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-19867 Filed 8-4-11; 8:45 am]
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