Document ID: FDA-2000-D-1542-0006
Agency: fda
Document Type: Notice
Title: Draft Guidance on Positron Emission Tomography Drug Applications - Content and Format for New Drug Applications, and Abbreviated New Drug Applications; Availability
Posted Date: 2011-02-03T05:00Z

[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Notices]
[Pages 6143-6144]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-2314]

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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]

Draft Guidance on Positron Emission Tomography Drug 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availability of a draft guidance entitled ``PET Drug Applications--
Content and Format for NDAs and ANDAs.'' The draft guidance is intended 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 (the FD&C Act) and FDA regulations. This draft 
guidance revises the draft guidance entitled ``Draft Guidance for 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; Availability,'' issued on March 10, 2000. 
Elsewhere in this issue of the Federal Register, FDA is announcing a 
public meeting to assist applicants in preparing NDAs or ANDAs for 
fludeoxyglucose (FDG) 18 injection, ammonia N 13 injection, and sodium 
fluoride F 18 injection used in PET imaging.

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draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by April 4, 2011.

[[Page 6144]]

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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, 
Silver Spring, MD 20993-0002, 301-796-3416.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``PET Drug Applications--Content and Format for NDAs and 
ANDAs.'' This draft guidance revises the draft guidance entitled 
``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; Availability,'' issued on March 10, 
2000. The revised guidance is being issued again as a draft for comment 
because FDA's perspective has changed significantly since issuance of 
the March 2000 draft guidance.
    The draft guidance is intended to assist the manufacturers of 
certain PET drugs--fludeoxyglucose (FDG) 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 draft 
guidance explains 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 
draft guidance further states when submission of a 505(b)(2) 
application or ANDA is appropriate and describes the information that 
manufacturers of these PET drugs should include in each type of 
application.
    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 
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 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. 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: January 28, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-2314 Filed 2-2-11; 8:45 am]
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