[Federal Register Volume 73, Number 233 (Wednesday, December 3, 2008)]
[Notices]
[Pages 73659-73660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-28657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0609]


Draft Guidance for Industry on the Submission of Patent 
Information for Certain Old Antibiotics; 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availability of a draft guidance for industry entitled ``Submission of 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 The draft guidance 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this draft guidance before it begins work on the final version of the 
guidance, submit written or electronic comments on the draft guidance 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ADDRESSES:  Submit written requests for single copies of the draft 
guidance to the Division of Drug Information, Center for Drug 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 Submit written comments on the draft guidance to the 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INFORMATION section for electronic access to the draft guidance 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    FDA is announcing the availability of a draft guidance for industry 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 The draft guidance provides information regarding FDA's 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

[[Page 73660]]

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.
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    \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.
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    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.
[FR Doc. E8-28657 Filed 12-2-08; 8:45 am]
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