[Federal Register Volume 76, Number 23 (Thursday, February 3, 2011)]
[Notices]
[Pages 6143-6144]
From the Federal Register Online via the Government Publishing 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Draft Guidance on Positron Emission Tomography Drug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availability of a draft guidance entitled ``PET Drug Applications--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 The draft guidance is intended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 This draft
guidance revises the draft guidance entitled ``Draft Guidance for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draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 4, 2011.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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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access to the draft guidance document.
Submit electronic comments on the draft guidance to http://www.regulations.gov.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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