[Federal Register: December 3, 2008 (Volume 73, Number 233)]
[Notices]
[Page 73659-73660]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr03de08-35]
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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Draft Guidance for Industry on the Submission of Patent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availability of a draft guidance for industry entitled ``Submission of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 The draft guidance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this draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information, Center for Drug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 Submit written comments on the draft guidance to the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INFORMATION section for electronic access to the draft guidance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FDA is announcing the availability of a draft guidance for industry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 The draft guidance provides information regarding FDA's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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