Document ID: FDA-2012-D-0080-0004
Agency: fda
Document Type: Notice
Title: Guidance on Oversight of Positron Emission Tomography Drug Products - Questions and Answers
Posted Date: 2012-12-04T05:00Z

[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71803-71804]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29157]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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 guidance entitled ``FDA Oversight of PET Drug 
Products--Questions and Answers.'' This 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: 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 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 this 
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: Elizabeth Giaquinto, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 51, Rm. 6164, Silver Spring, MD 20993-0002, 301-
796-3416.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a 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) (Public Law 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 several guidance documents specific 
to PET drug producers \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 
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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    A draft guidance of the same title was announced in the Federal 
Register on February 27, 2012 (77 FR 11553), and Docket No. FDA 2012-D-
0080 was open for public comment until May 29, 2012. We received one 
set of comments from industry. We have carefully considered the 
comments, and where appropriate, we have made corrections, added 
information, or clarified the information in this guidance in response 
to the comments or on our own initiative. In addition, we have added 
six new questions and answers (see questions 63, 64, 65, 66, 88, and 
89).
    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 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 either written comments regarding 
this document to the Division of Dockets Management (see ADDRESSES) or 
electronic comments to http://www.regulations.gov. 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.

[[Page 71804]]

and 4 p.m., Monday through Friday, and will be posted to the docket at 
http://www.regulations.gov.

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 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 
0910-0045. The 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: November 28, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-29157 Filed 12-3-12; 8:45 am]
BILLING CODE 4160-01-P