In accordance with section 10(d) of the Federal Advisory Committee Act (5 U.S.C., Appendix 2), announcement is made of a Health Care Policy and Research Special Emphasis Panel (SEP) meeting., 31449-31450 [2010-13109]
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31449
Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices
regulations governing requirements for
human drug products to establish
standardized format and content
requirements for the labeling of all
marketed OTC drug products in part 201
(21 CFR part 201) (the 1999 labeling
final rule). The regulations in part 201
require OTC drug product labeling to
include uniform headings and
subheadings, presented in a
standardized order, with minimum
standards for type size and other
graphical features. Specifically, the 1999
labeling final rule added new § 201.66
to part 201. Section 201.66 sets content
and format requirements for the Drug
Facts portion of labels on OTC drug
products.
The only burden to comply with the
regulations in part 201 is a one-time
burden for OTC sunscreen products and
new OTC drug products introduced to
the marketplace under new drug
applications (NDAs) or abbreviated new
drug applications (ANDAs). All OTC
drug products except sunscreens and
new OTC products marketed under
NDAs or ANDAs are already required to
be in compliance with these labeling
regulations. On June 20, 2000 (65 FR
38191), we published a Federal Register
document that required all OTC drug
products marketed under the OTC
monograph system except sunscreen
products to comply with the regulations
by May 16, 2005, or sooner (65 FR
38191 at 38193). Sunscreen products do
not have to comply with the regulations
until we lift the stay of the sunscreen
final rule that was published in the
Federal Register on May 21, 1999 (64
FR 27666) (the 1999 sunscreen final
rule). In the Federal Register of
December 31, 2001 (66 FR 67485), we
stayed the 1999 sunscreen final rule
indefinitely. In the Federal Register of
September 3, 2004 (69 FR 53801), we
delayed the § 201.66 implementation
date for OTC sunscreen products
indefinitely. Because the compliance
date has passed for all OTC drug
products except sunscreens and drug
products introduced under new NDAs
or ANDAs, we believe that the labeling
burden associated with the 1999
labeling final rule applies only to these
products. We do not anticipate receiving
any requests for exemptions or deferrals
under § 201.66(e) because we have only
received one request in the past 8 years.
We estimate that there are 4,750 OTC
sunscreen drug product stock keeping
units (SKUs) that have not yet complied
with the 1999 labeling final rule. All of
these SKUs will need to implement the
new labeling format by the
implementation date included in the
1999 sunscreen final rule when it is
published in the Federal Register. We
estimate that these 4,750 SKUs are
marketed by 400 manufacturers and that
approximately 2 hours will be spent on
each submission (see table 1 of this
document). The number of hours per
submission (response) is based on our
estimate in the 1999 labeling final rule
(64 FR 13254 at 13276). If an average of
2 hours is spent preparing, completing,
and reviewing each of the estimated
4,750 sunscreen SKUs, the total number
of hours dedicated to the labeling of
sunscreen products would be 9,500
hours (4,750 SKUs times 2 hours/SKU)
(see table 1 of this document).
Based on estimates provided by the
Consumer Healthcare Products
Association, we believe that
approximately 500 new OTC drug
product SKUs marketed under NDAs or
ANDAs are introduced to the
marketplace each year. We estimate that
these SKUs are marketed by 300
manufacturers. We estimate that the
preparation of labeling for new NDAs
and ANDAs will require 5 hours to
prepare, complete, and review new
labeling prior to submitting the new
labeling to us. Based on this estimate,
the annual reporting burden for this
type of labeling is approximately 2,500
hours (see table 1 of this document).
FDA estimates the burden of this
collection of information as follows:
TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1
No. of
Respondents
21 CFR Section
Annual Frequency per
Response
Total Annual
Responses
Hours per
Response
Total Hours
201.66(c) and (d)2
400
11.88
4,750
2
9,500
201.66(c) and (d)3
300
1.67
500
5
2,500
Total
12,000
1 FDA
estimates that capital costs of 22 to 25 million dollars will result from preparing labeling content and format in accordance with § 201.66.
There are no operating or maintenance costs associated with this collection of information.
2 Burden for manufacturers of sunscreen drug product.
3 Burden for manufacturers of products marketed under new NDAs or ANDAs.
Dated: May 27, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010–13279 Filed 6–2–10; 8:45 am]
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality; Notice of Meeting
sroberts on DSKD5P82C1PROD with NOTICES
BILLING CODE 4160–01–S
In accordance with section 10(d) of the
Federal Advisory Committee Act (5
U.S.C., Appendix 2), announcement is
made of a Health Care Policy and
Research Special Emphasis Panel
(SEP) meeting.
A Special Emphasis Panel is a group
of experts in fields related to health care
research who are invited by the Agency
for Healthcare Research and Quality
(AHRQ), and agree to be available, to
conduct on an as needed basis,
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scientific reviews of applications for
AHRQ support. Individual members of
the Panel do not attend regularlyscheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
particular review meetings which
require their type of expertise.
Substantial segments of the upcoming
SEP meeting listed below will be closed
to the public in accordance with the
Federal Advisory Committee Act,
section 10(d) of 5 U.S.C., Appendix 2
and 5 U.S.C. 552b(c)(6). Grant
applications for the AHRQ Limited
Competition: PROSPECT STUDIES—
Building New Clinical Infrastructure for
CE (R01) applications are to be reviewed
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31450
Federal Register / Vol. 75, No. 106 / Thursday, June 3, 2010 / Notices
and discussed at this meeting. These
discussions are likely to reveal personal
information concerning individuals
associated with the applications. This
information is exempt from mandatory
disclosure under the above-cited
statutes.
SEP Meeting on: AHRQ Limited
Competition: PROSPECT STUDIES—
Building New Clinical Infrastructure for
CE (R01).
Date: June 16, 2010 (Open on June 16
from 8 a.m. to 8:15 a.m. and closed for
the remainder of the meeting).
Place: Hyatt Regency Bethesda Hotel,
7400 Wisconsin Avenue, 1 Bethesda
Metro Center, Bethesda, Maryland
20814.
Contact Person: Anyone wishing to
obtain a roster of members, agenda or
minutes of the non-confidential portions
of this meeting should contact Mrs.
Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research, Education and
Priority Populations, AHRQ, 540
Gaither Road, Room 2038, Rockville,
Maryland 20850, Telephone (301) 427–
1554.
Agenda items for this meeting are
subject to change as priorities dictate.
Dated: May 24, 2010.
Carol M. Clancy,
Director.
[FR Doc. 2010–13109 Filed 6–2–10; 8:45 am]
BILLING CODE 4160–90–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality; Notice of Meeting
sroberts on DSKD5P82C1PROD with NOTICES
In accordance with section 10(d) of
the Federal Advisory Committee Act (5
U.S.C., Appendix 2), announcement is
made of a Health Care Policy and
Research Special Emphasis Panel (SEP)
meeting.
A Special Emphasis Panel is a group
of experts in fields related to health care
research who are invited by the Agency
for Healthcare Research and Quality
(AHRQ), and agree to be available, to
VerDate Mar<15>2010
18:21 Jun 02, 2010
Jkt 220001
conduct on an as-needed basis,
scientific reviews of applications for
AHRQ support. Individual members of
the Panel do not attend regularlyscheduled meetings and do not serve for
fixed terms or a long period of time.
Rather, they are asked to participate in
particular review meetings which
require their type of expertise.
Substantial segments of the upcoming
SEP meeting listed below will be closed
to the public in accordance with the
Federal Advisory Committee Act,
section 10(d) of 5 U.S.C., Appendix 2
and 5 U.S.C. 552b(c)(6). Grant
applications for the OS ARRA:
Optimizing Prevention and Healthcare
Management for Complex Patients (R21)
applications are to be reviewed and
discussed at this meeting. These
discussions are likely to reveal personal
information concerning individuals
associated with the applications. This
information is exempt from mandatory
disclosure under the above-cited
statutes.
SEP Meeting on: OS ARRA:
Optimizing Prevention and Healthcare
Management for Complex Patients
(R21).
Date: June 24, 2010 (Open on June 24
from 8 a.m. to 8:15 a.m. and closed for
the remainder of the meeting).
Place: Hilton Rockville Executive
Meeting Center, 1750 Rockville Pike,
Conference Room TBD, Rockville, MD
20850.
Contact Person: Anyone wishing to
obtain a roster of members, agenda or
minutes of the nonconfidential portions
of this meeting should contact Mrs.
Bonnie Campbell, Committee
Management Officer, Office of
Extramural Research, Education and
Priority Populations, AHRQ, 540
Gaither Road, Room 2038, Rockville,
Maryland 20850, Telephone (301) 427–
1554.
Agenda items for this meeting are
subject to change as priorities dictate.
Dated: May 24, 2010.
Carolyn M. Clancy,
Director.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2010–N–0004]
[FDA 225–09–0014]
Memorandum of Understanding by and
Between the United States Food and
Drug Administration and the
International Anesthesia Research
Society for the Safety of Key Inhaled
and Intravenous Drugs in Pediatrics
Public-Private Partnership
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is providing
notice of a memorandum of
understanding (MOU) between FDA and
the International Anesthesia Research
Society (IARS). The purpose of this
MOU is to establish a framework for
collaboration between FDA and IARS
and to support their shared interest of
promoting the safe use of anesthetics
and sedatives in children.
DATES: The agreement became effective
March 21, 2010.
FOR FURTHER INFORMATION CONTACT:
Wendy R. Sanhai, Senior Scientific
Advisor, Office of the Commissioner,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 32, rm.
4128, Silver Spring, MD 20993, 301–
796–8518.
In
accordance with 21 CFR 20.108(c),
which states that all written agreements
and MOUs between FDA and others
shall be published in the Federal
Register, the agency is publishing notice
of this MOU.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2010–13108 Filed 6–2–10; 8:45 am]
Dated: May 26, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
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[Federal Register Volume 75, Number 106 (Thursday, June 3, 2010)]
[Notices]
[Pages 31449-31450]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-13109]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality; Notice of Meeting
In accordance with section 10(d) of the Federal Advisory
Committee Act (5 U.S.C., Appendix 2), announcement is made of a Health
Care Policy and Research Special Emphasis Panel (SEP) meeting.
A Special Emphasis Panel is a group of experts in fields related to
health care research who are invited by the Agency for Healthcare
Research and Quality (AHRQ), and agree to be available, to conduct on
an as needed basis, scientific reviews of applications for AHRQ
support. Individual members of the Panel do not attend regularly-
scheduled meetings and do not serve for fixed terms or a long period of
time. Rather, they are asked to participate in particular review
meetings which require their type of expertise.
Substantial segments of the upcoming SEP meeting listed below will
be closed to the public in accordance with the Federal Advisory
Committee Act, section 10(d) of 5 U.S.C., Appendix 2 and 5 U.S.C.
552b(c)(6). Grant applications for the AHRQ Limited Competition:
PROSPECT STUDIES--Building New Clinical Infrastructure for CE (R01)
applications are to be reviewed
[[Page 31450]]
and discussed at this meeting. These discussions are likely to reveal
personal information concerning individuals associated with the
applications. This information is exempt from mandatory disclosure
under the above-cited statutes.
SEP Meeting on: AHRQ Limited Competition: PROSPECT STUDIES--
Building New Clinical Infrastructure for CE (R01).
Date: June 16, 2010 (Open on June 16 from 8 a.m. to 8:15 a.m. and
closed for the remainder of the meeting).
Place: Hyatt Regency Bethesda Hotel, 7400 Wisconsin Avenue, 1
Bethesda Metro Center, Bethesda, Maryland 20814.
Contact Person: Anyone wishing to obtain a roster of members,
agenda or minutes of the non-confidential portions of this meeting
should contact Mrs. Bonnie Campbell, Committee Management Officer,
Office of Extramural Research, Education and Priority Populations,
AHRQ, 540 Gaither Road, Room 2038, Rockville, Maryland 20850, Telephone
(301) 427-1554.
Agenda items for this meeting are subject to change as priorities
dictate.
Dated: May 24, 2010.
Carol M. Clancy,
Director.
[FR Doc. 2010-13109 Filed 6-2-10; 8:45 am]
BILLING CODE 4160-90-M
