2011-22373. 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.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled “PET Drug Applications—Content and Format for NDAs and ANDAs.” This document 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 (FD&C Act) and FDA regulations.

DATES:

Submit either electronic or written comments on Agency guidances at any time.

ADDRESSES:

Submit written requests for single copies of the 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:

Elizabeth Giaquinto, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6164, Silver Spring, MD 20993, 301-796-3416.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a guidance for industry entitled “PET Drug Applications—Content and Format for NDAs and ANDAs.” The guidance is intended to assist the manufacturers of certain PET drugs—fludeoxyglucose 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 guidance states 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 guidance further explains when submission of a 505(b)(2) application or ANDA is appropriate and describes the information that manufacturers of these PET drugs include in each type of application.

A revised draft guidance of the same title was announced in the Federal Register on February 3, 2011 (76 FR 6143), and Docket No. FDA-2000-D-1542 was open for comments until April 4, 2011. The February 3, 2011, draft guidance was a revision of the document “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,” issued on March 10, 2000 (65 FR 13010). The February 3, 2011, revised guidance was issued as a draft for comment because FDA's perspective has changed significantly since the issuance of the March 2000 draft guidance. 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 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. 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). The collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001; the collections of information required on Form FDA-356h have been approved under OMB control number 0910-0338; and the collections of information required on Form FDA-3397 have been approved under OMB control number 0910-0297.

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: August 25, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.