E8-28657. Draft Guidance for Industry on the Submission of Patent Information for Certain Old Antibiotics; Availability

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Submission of Patent Information for Certain Old Antibiotics.” The draft guidance describes the agency's current thinking on the implementation of certain provisions of the Q1 Program Supplemental Funding Act (the Q1 Act) that concern old antibiotics and addresses which sponsors of new drug applications (NDAs) must submit patent information under the Q1 Act by December 5, 2008.

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comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by February 2, 2009.

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Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201,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. Submit written comments on the draft guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT:

Mary Ann Holovac, Center for Drug Evaluation and Research (HFD-615), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8971.

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability of a draft guidance for industry entitled “Submission of Patent Information for Certain Old Antibiotics.” The draft guidance provides information regarding FDA's current thinking on the implementation of section 4(b)(1) of the Q1 Act (Public Law 110-379).

The Q1 Act amends section 505 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355) by adding subsection (v), which establishes, among other things, certain conditions under which the patent listing, patent certification, and marketing exclusivity provisions of sections 505(c) and (j) of the FD&C Act, and the patent term extension provisions of 35 U.S.C. 156 apply to marketing applications for drugs that contain an antibiotic that was the subject of any marketing application received by FDA on or before November 20, 1997 (an old antibiotic). The transitional rules at section 4(b) of the Q1 Act provide for the submission of the patent information by sponsors of certain NDAs, the publication of such patent information by FDA, and the certification to such patents by applicants of pending abbreviated new drug applications to be deemed “a first applicant” (as defined in section 505(j)(5)(B)(iv) the FD&C Act), not later than 60, 90, and 120 days after enactment of the Q1 Act, respectively.

Specifically, section 4(b)(1) of the Q1 Act requires the submission to FDA of patent information by sponsors of certain NDAs for drugs (including combination drugs) containing old antibiotics by December 5, 2008.¹ The draft guidance describes FDA's current thinking on the implementation of section 4(b)(1) of the Q1 Act and addresses which sponsors of NDAs must submit patent information to the agency under section 4(b)(1) of the Q1 Act by December 5, 2008.

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 patent information under section 4(b)(1) of the Q1 Act. 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) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified 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.

Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov.

III. Paperwork Reduction Act of 1995

This draft 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 314.50(h) and 314.53 have been approved under OMB control number 0910-0513.

IV. Electronic Access

Persons with access to the Internet may obtain the document at either http://www.fda.gov/​cder/​guidance/​index.htm or http://www.regulations.gov.

Dated: November 26, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.

Footnotes

1.  Section 4(b)(1) of the Q1 Act requires the submission of patent information to FDA “not later than sixty days after enactment of [the Q1 Act].” Sixty days after enactment falls on Sunday, December 7, 2008. Therefore, to be in compliance with this provision, sponsors must submit the patent information on or before the weekday preceding December 7, 2008, that is, on or before December 5, 2008.