Document ID: FDA-2000-D-1542-0012
Agency: fda
Document Type: Notice
Title: Guidance on Positron Emission Tomography Drug Applications; Availability: Content and Format for New Drug Applications and Abbreviated New Drug Applications
Posted Date: 2011-09-01T04:00Z

[Federal Register Volume 76, Number 170 (Thursday, September 1, 2011)]
[Notices]
[Pages 54473-54474]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-22373]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-D-1542 (formerly Docket No. 00D-0892)]

Guidance on Positron Emission Tomography Drug Applications--
Content and Format for New Drug Applications and Abbreviated New Drug 
Applications; 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 industry entitled ``PET Drug 
Applications--Content and Format for NDAs and ANDAs.'' This document is 
intended to assist manufacturers of certain positron emission 
tomography (PET) drugs in submitting new drug applications (NDAs) or 
abbreviated new drug applications (ANDAs) in accordance with the 
Federal Food, Drug, and Cosmetic Act (FD&C Act) and FDA regulations.

DATES: Submit either electronic or written comments on Agency guidances 
at any time.

ADDRESSES: Submit written requests for single copies of the 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 
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, 301-796-
3416.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``PET Drug Applications--Content and Format for NDAs and 
ANDAs.'' The guidance is intended to assist the manufacturers of 
certain PET drugs--fludeoxyglucose F 18 injection, ammonia N 13 
injection, and sodium fluoride F 18 injection--in submitting NDAs and 
ANDAs in accordance with the FD&C Act and FDA regulations. The guidance 
states that to continue marketing these PET drugs for clinical use, 
manufacturers of these drugs must submit NDAs of the type described in 
section 505(b)(2) of the FD&C Act (21 U.S.C. 355(b)(2)) or ANDAs under 
section 505(j) of the FD&C Act by December 12, 2011. The guidance 
further explains when submission of a 505(b)(2) application or ANDA is 
appropriate and describes the information that manufacturers of these 
PET drugs include in each type of application.
    A revised draft guidance of the same title was announced in the 
Federal Register on February 3, 2011 (76 FR 6143), and Docket No. FDA-
2000-D-1542 was open for comments until April 4, 2011. The February 3, 
2011, draft guidance was a revision of the document ``Draft Guidance 
for Industry on the Content and Format of New Drug Applications and 
Abbreviated New Drug Applications for Certain Positron Emission 
Tomography Drug Products,'' issued on March 10, 2000 (65 FR 13010). The 
February 3, 2011, revised guidance was issued as a draft for comment 
because FDA's perspective has changed significantly since the issuance 
of the March 2000 draft guidance. We received comments from industry 
and professional societies. We have carefully considered 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.
    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 submission of NDAs and ANDAs 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

[[Page 54474]]

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 314 have been approved under 
OMB control number 0910-0001; the collections of information required 
on Form FDA-356h have been approved under OMB control number 0910-0338; 
and the collections of information required on Form FDA-3397 have been 
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: August 25, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-22373 Filed 8-31-11; 8:45 am]
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