2011-2314. Draft Guidance on Positron Emission Tomography Drug Applications-Content and Format for New Drug Applications and Abbreviated New Drug Applications; Availability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.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled “PET Drug Applications—Content and Format for NDAs and ANDAs.” The draft guidance is intended to assist manufacturers of certain positron emission tomography (PET) drugs in submitting new drug applications (NDAs) or abbreviated new drug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 This draft guidance revises the draft guidance entitled “Draft Guidance for Industry on the Content and Format of New Drug Applications and Abbreviated New Drug Applications for Certain Positron Emission Tomography Drug Products;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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 4, 2011.

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Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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 See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

Submit electronic comments on the draft guidance to http://www.regulations.gov.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.