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Daily Rules, Proposed Rules, and Notices of the Federal Government

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.
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 theSUPPLEMENTARY INFORMATIONsection for electronic access to the guidance document.

Submit electronic comments on the guidance tohttp://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A draft guidance of the same title was announced in theFederal Registeron February 14, 2012 (77 FR 8262), and Docket No. FDA-2012-D-0081 was open for comments until May 14,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.

II. Comments

Interested persons may submit either written comments regarding this document to the Division of Dockets Management (seeADDRESSES) or electronic comments tohttp://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 athttp://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 §§ 314.50 and 314.94 (21 CFR 314.50 and 314.94). The collections of information in part 312 and in §§ 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 eitherhttp://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htmorhttp://www.regulations.gov.

Dated: November 28, 2012. Leslie Kux, Assistant Commissioner for Policy.