Document ID: FDA-2012-D-0081-0008
Agency: fda
Document Type: Notice
Title: Guidance on Investigational New Drug Applications for Positron Emission Tomography Drugs
Posted Date: 2012-12-04T05:00Z

[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71802-71803]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-29163]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0081]

Guidance on Investigational New Drug Applications for Positron 
Emission Tomography Drugs; 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 ``Investigational New Drug 
Applications for Positron Emission Tomography (PET) Drugs.'' The 
guidance is intended to assist manufacturers of PET drugs in submitting 
investigational new drug applications (INDs).

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 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: Kyong (Kaye) Kang, Center for Drug 
Evaluation and Research, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 22, Rm. 2352, Silver Spring, MD 20993-0002, 301-
796-2050.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance entitled 
``Investigational New Drug Applications for Positron Emission 
Tomography (PET) Drugs.'' The guidance summarizes the IND process for 
PET drugs, makes recommendations for how to submit an IND, provides 
advice on expanded access options for investigational PET drugs, and 
describes the process for requesting permission to charge for an 
investigational PET drug.
    A draft guidance of the same title was announced in the Federal 
Register on February 14, 2012 (77 FR 8262), and Docket No. FDA-2012-D-
0081 was open for comments until May 14, 2012. 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 INDs 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.

[[Page 71803]]

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. 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). INDs 
and requests to charge for a drug under an IND are submitted to FDA 
under part 312 (21 CFR part 312). New drug applications and abbreviated 
new drug applications are submitted to FDA under Sec. Sec.  314.50 and 
314.94 (21 CFR 314.50 and 314.94). The collections of information in 
part 312 and in Sec. Sec.  314.50 and 314.94 have been approved under 
OMB control numbers 0910-0014 and 0910-0001.

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. 2012-29163 Filed 12-3-12; 8:45 am]
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