[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71803-71804]
From the Federal Register Online via the Government Publishing 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]
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