Draft Guidance for Industry on the Submission of Patent Information for Certain Old Antibiotics; Availability, 73659-73660 [E8-28657]
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Federal Register / Vol. 73, No. 233 / Wednesday, December 3, 2008 / Notices
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Jkt 217001
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Approved: November 25, 2008.
Michael O. Leavitt,
Secretary.
[FR Doc. E8–28619 Filed 12–2–08; 8:45 am]
BILLING CODE 4120–01–P
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Draft Guidance for Industry on the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.
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availability of a draft guidance for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 The draft guidance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considers your comment on this draft
guidance before it begins work on the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draft guidance by February 2, 2009.
PO 00000
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73659
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single copies of the draft guidance to the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the draft guidance to the Division of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 https://
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electronic access to the draft guidance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:
ADDRESSES:
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
E:\FR\FM\03DEN1.SGM
03DEN1
73660
Federal Register / Vol. 73, No. 233 / Wednesday, December 3, 2008 / Notices
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
https://www.regulations.gov.
III. Paperwork Reduction Act of 1995
jlentini on PROD1PC65 with NOTICES
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
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.
VerDate Aug<31>2005
13:59 Dec 02, 2008
Jkt 217001
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
https://www.fda.gov/cder/guidance/
index.htm or https://
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]
BILLING CODE 4160–01–S
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of General Medical
Sciences; Notice of Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. Appendix 2), notice
is hereby given of the following
meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute of
General Medical Sciences, Special Emphasis
Panel, Large-Scale Collaborative Project
Awards (U54).
Date: December 22, 2008.
Time: 8:30 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892, (Virtual Meeting).
Contact Person: Lisa Dunbar, PhD,
Scientific Review Officer, Office of Scientific
Review, National Institute of General Medical
Sciences, National Institutes of Health, 45
Center Drive, Room 3AN12, Bethesda, MD
20892, 301–594–2849, dunbarl@mail.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.375, Minority Biomedical
Research Support; 93.821, Cell Biology and
Biophysics Research; 93.859, Pharmacology,
Physiology, and Biological Chemistry
Research; 93.862, Genetics and
Developmental Biology Research; 93.88,
Minority Access to Research Careers; 93.96,
Special Minority Initiatives, National
Institutes of Health, HHS)
PO 00000
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Fmt 4703
Sfmt 4703
Dated: November 21, 2008.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. E8–28509 Filed 12–2–08; 8:45 am]
BILLING CODE 4140–01–M
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
Agency Information Collection
Activities: Submission for OMB
Review; Comment Request
Federal Emergency
Management Agency, DHS.
ACTION: Notice; 30-day notice and
request for comments; Extension,
without change, of a currently approved
collection, OMB Number 1660–0024, No
Form.
AGENCY:
SUMMARY: The Federal Emergency
Management Agency (FEMA) has
submitted the following information
collection to the Office of Management
and Budget (OMB) for review and
clearance in accordance with the
requirements of the Paperwork
Reduction Act of 1995. The submission
describes the nature of the information
collection, the categories of
respondents, the estimated burden (i.e.,
the time, effort and resources used by
respondents to respond) and cost, and
includes the actual data collection
instruments FEMA will use.
Collection of Information
Title: Federal Assistance for Offsite
Radiological Emergency Planning.
OMB Number: 1660–0024.
Abstract: In accordance with
Executive Order 12657, FEMA will need
certain information from the licensee
(the utility which has applied for or
received a license from the Nuclear
Regulatory Commission (NRC) to
operate a nuclear power plant) in order
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the part of State or local governments
(44 CFR 352.3–4). This information will
be collected by the appropriate FEMA
Regional Office or Headquarters.
Affected Public: Business or other forprofit.
Number of Respondents: 1.
Estimated Time per Respondent: 160
hours.
Estimated Total Annual Burden
Hours: 160 hours.
Frequency of Response: Once.
Comments: Interested persons are
invited to submit written comments on
E:\FR\FM\03DEN1.SGM
03DEN1
]]>Agencies
[Federal Register Volume 73, Number 233 (Wednesday, December 3, 2008)]
[Notices]
[Pages 73659-73660]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-28657]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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 https://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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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 https://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 https://www.fda.gov/cder/guidance/index.htm or https://
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]
BILLING CODE 4160-01-S
