[Federal Register Volume 77, Number 233 (Tuesday, December 4, 2012)]
[Notices]
[Pages 71802-71803]
From the Federal Register Online via the Government Publishing 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A draft guidance of the same title was announced in the Federal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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