[Federal Register Volume 77, Number 38 (Monday, February 27, 2012)]
[Notices]
[Pages 11553-11554]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-4427]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0080]


Draft Guidance on Food and Drug Administration Oversight of 
Positron Emission Tomography Drug Products--Questions and Answers; 
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availability of a draft guidance entitled ``FDA Oversight of PET Drug 
Products--Questions and Answers.'' The draft guidance provides 
questions and answers that address nearly all aspects of the FDA 
approval and surveillance processes, including application submission, 
review, compliance with good manufacturing practices, inspections, 
registration and listing, and user fees.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment on this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by May 29, 2012.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov.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: Elizabeth Giaquinto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave. Bldg. 51, rm. 6164,

[[Page 11554]]

Silver Spring, MD 20993-0002, 301-796-3416.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance entitled 
``FDA Oversight of PET Drug Products--Questions and Answers.'' In 1997, 
Congress passed the Food and Drug Administration Modernization Act (the 
Modernization Act) (Pub. L. 105-115). Section 121 of the Modernization 
Act directed FDA to establish appropriate approval procedures and 
current good manufacturing practices (CGMP) for PET drugs. The 
procedures were finalized and an implementation timeline was instituted 
on December 10, 2009, when FDA published regulations that described the 
minimum CGMP standards that each PET drug manufacturer is to follow 
during the production of a PET drug (see part 212 (21 CFR part 
212)).\1\ Under the requirements of section 121 of the Modernization 
Act, within 2 years following that publication date, a new drug 
application (NDA) or abbreviated new drug application (ANDA) must be 
submitted for any PET drug marketed for clinical use in the United 
States.
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    \1\ The regulation, CGMP guidance, and supportive information, 
including historical documents, are available at http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufacturing/ucm085783.htm.
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    Recognizing that many PET drug producers are unfamiliar with the 
drug approval process, FDA issued the guidance entitled PET Drug 
Applications--Content and Format for NDAs and ANDAs,\2\ and held a 
public meeting in March 2011 to assist applicants in preparing NDAs and 
ANDAs for the three most commonly used PET drugs. Numerous questions 
have been raised since that public meeting on all aspects of FDA 
oversight of PET drugs. This draft guidance is being issued to respond 
to the questions that have been submitted to date, and it will be 
revised periodically to respond to additional questions that have been 
submitted and are expected to be submitted in the future.
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    \2\ We update guidances periodically. To make sure you have the 
most recent version of a guidance, check FDA's Drugs guidance Web 
page at: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
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    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent the Agency's current thinking on the FDA 
oversight of 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. 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 draft 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 314 were approved under OMB 
control numbers 0910-0001 and 0910-0338; the collections of information 
in 21 CFR part 312 were approved under OMB control number 0910-0014; 
the collections of information in part 212 were approved under OMB 
control number 0910-0667; the collections of information in 21 CFR 
parts 210 and 211 were approved under 0910-0139; and the collections of 
information in 21 CFR part 207 were approved under OMB control number 
0910-0445. The draft guidance also refers to collections of information 
associated with submitting Form FDA 3397 (Prescription Drug User Fee 
Cover Sheet), approved under OMB control number 0910-0297.

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: February 21, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-4427 Filed 2-24-12; 8:45 am]
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