Clinical Center; Notice of Meeting, 77543-77544 [2011-31929]
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Federal Register / Vol. 76, No. 239 / Tuesday, December 13, 2011 / Notices
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Regulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: December 7, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–31867 Filed 12–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0813]
Quantitative Summary of the Benefits
and Risks of Prescription Drugs: A
Literature Review
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft report entitled
‘‘Quantitative Summary of the Benefits
and Risks of Prescription Drugs: A
Literature Review’’ (literature review
report). A literature review was
conducted to address a requirement of
the Patient Protection and Affordable
Care Act (Affordable Care Act). FDA is
publishing the literature review report
to allow the public to provide comment
on the report as it relates to the
Affordable Care Act.
DATES: Submit either electronic or
written comments on the literature
review report by February 13, 2012.
ADDRESSES: You may submit comments,
identified by Docket No. 2011–N–0813,
by any of the following methods:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
srobinson on DSK4SPTVN1PROD with NOTICES
Written Submissions
Submit written submissions in the
following ways:
• Fax: (301) 827–6870.
• Mail/Hand delivery/Courier (for
paper, disk, or CD–ROM submissions):
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852.
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18:10 Dec 12, 2011
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FOR FURTHER INFORMATION CONTACT:
Helen Sullivan, Office of Prescription
Drug Promotion, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 51, Rm. 3263, Silver Spring,
MD 20993–0002, (301) 796–1200, email:
helen.sullivan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft report entitled ‘‘Quantitative
Summary of the Benefits and Risks of
Prescription Drugs: A Literature
Review.’’ A literature review was
conducted to address section 3507 1 of
the Affordable Care Act (see https://
www.gpo.gov/fdsys/pkg/PLAW111publ148/pdf/PLAW-111
publ148.pdf). Section 3507(a) requires
the Secretary of Health and Human
Services (HHS), acting through the
Commissioner of Food and Drugs, to
determine whether the addition of
quantitative summaries of the benefits
and risks of prescription drugs in
standardized format (e.g., similar to
‘‘Drug Facts’’ on over-the-counter
products) to the promotional labeling or
print advertising of such drugs would
‘‘improve health care decisionmaking by
clinicians and patients and consumers’’
(section 3507(a), Pub. L. 111–148, 124
Stat. 530). In making this determination,
the law directs FDA to ‘‘review all
available scientific evidence and
research on decisionmaking and social
and cognitive psychology’’ (section
3507(b), Pub. L. 111–148, 124 Stat. 530),
and to consult manufacturers and
consumers, experts in health literacy,
representatives of racial and ethnic
minorities, and experts in women’s and
pediatric health.
To fulfill this requirement, FDA has
commissioned an objective review of
science-based studies related to the
communication of quantitative benefit
and risk information. FDA is making
available the literature review report
and is providing a comment period for
interested parties to comment on the
literature review report as it relates to
section 3507 of the Affordable Care Act.
II. Electronic Access
Persons with access to the Internet
may obtain the literature review report
at https://www.regulations.gov.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding the literature
review report. It is only necessary to
1 Public Law, 111–148, 124 Stat. 119, 530
(codified at note following 21 U.S.C. 352).
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77543
send one set of comments. It is no
longer necessary to send two copies of
mailed comments. Identify comments
with the docket number found in
brackets in the heading of this
document and labeled ‘‘ATTN:
Literature Review.’’ Received comments
may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
All submissions received must
include the agency name and docket
number. All comments received may be
posted without change to https://
www.regulations.gov, including any
personal information provided.
Dated: December 8, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–31931 Filed 12–12–11; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Clinical Center; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the NIH
Advisory Board for Clinical Research.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended to
discuss personnel matters, the
disclosure of which would constitute a
clearly unwarranted invasion of privacy.
Name of Committee: NIH Advisory Board
for Clinical Research.
Date: January 30, 2012.
Time: 10 a.m. to 1:15 p.m.
Agenda: To review the 2012 Clinical
Center Strategic and Annual Operating Plan
and provide updates on selected
organizational initiatives.
Place: National Institutes of Health,
Building 10, 10 Center Drive, CRC Medical
Board Room 4–2551, Bethesda, MD 20892.
Closed: 1:15 p.m. to 2 p.m.
Agenda: To review and evaluate to discuss
personnel matters.
Place: National Institutes of Health,
Building 10, 10 Center Drive, CRC Medical
Board Room 4–2551, Bethesda, MD 20892.
Contact Person: Maureen E Gormley,
Executive Secretary, Mark O. Hatfield
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Federal Register / Vol. 76, No. 239 / Tuesday, December 13, 2011 / Notices
Clinical Research Center, National Institutes
of Health, Building 10, Room 6–2551,
Bethesda, MD 20892, (301) 496–2897.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
Dated: December 6, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–31929 Filed 12–12–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
srobinson on DSK4SPTVN1PROD with NOTICES
National Institute of Arthritis and
Musculoskeletal and Skin Diseases;
Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Arthritis and Musculoskeletal
and Skin Diseases Advisory Council.
The meeting will be open to the
public as indicated below, with
attendance limited to space available.
Individuals who plan to attend and
need special assistance, such as sign
language interpretation or other
reasonable accommodations, should
notify the Contact Person listed below
in advance of the 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 Arthritis and
Musculoskeletal and Skin Diseases Advisory
Council.
Date: January 31, 2012.
Open: 8:30 a.m. to 12 p.m.
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16:25 Dec 12, 2011
Jkt 226001
Agenda: To discuss administrative details
relating to the Council’s business and special
reports.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6, Bethesda, MD 20892.
Closed: 1 p.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Conference
Room 6, Bethesda, MD 20892.
Contact Person: Laura K. Moen, Ph.D,
Director, Division of Extramural Research
Activities, NIAMS/NIH, 6701 Democracy
Blvd., Ste 800, Bethesda, MD 20892, (301)
451–6515, moenl@mail.nih.gov.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person.
In the interest of security, NIH has
instituted stringent procedures for entrance
onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles
will be inspected before being allowed on
campus. Visitors will be asked to show one
form of identification (for example, a
government-issued photo ID, driver’s license,
or passport) and to state the purpose of their
visit.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.846, Arthritis,
Musculoskeletal and Skin Diseases Research,
National Institutes of Health, HHS)
Name of Committee: National Children’s
Study Advisory Committee.
Date: January 24, 2012.
Time: 9 a.m. to 5 p.m.
Agenda: The NCS will receive an update
on Vanguard Study activities and an
additional update on plans for the Main
Study.
Place: National Institutes of Health,
Natcher Building, 45 Center Drive, Bethesda,
MD 20892.
Contact Person: Kate Winseck, MSW,
Executive Secretary, National Children’s
Study, Eunice Kennedy Shriver National
Institute of Child Health and Human
Development, NIH, 6100 Executive Blvd.,
Room 5C01, Bethesda, MD 20892, (703) 902–
1339, ncs@circlesolutions.com.
Any interested person may file written
comments with the committee by forwarding
the statement to the Contact Person listed on
this notice. The statement should include the
name, address, telephone number and when
applicable, the business or professional
affiliation of the interested person. For
additional information about the Federal
Advisory Committee meeting, please contact
Circle Solutions at ncs@circlesolutions.com.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.864, Population Research;
93.865, Research for Mothers and Children;
93.929, Center for Medical Rehabilitation
Research; 93.209, Contraception and
Infertility Loan Repayment Program, National
Institutes of Health, HHS)
Dated: December 6, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
Dated: December 6, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–31927 Filed 12–12–11; 8:45 am]
[FR Doc. 2011–31926 Filed 12–12–11; 8:45 am]
BILLING CODE 4140–01–P
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Meeting
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(a) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Children’s Study Advisory
Committee.
The meeting will be open to the
public, with attendance limited to space
available. Registration is required since
space is limited and will begin at 8 a.m.
Please visit the conference Web site for
information on meeting logistics and to
register for the meeting https://
www.cvent.com/d/xcq841. Individuals
who plan to attend and need special
assistance, such as sign language
interpretation or other reasonable
accommodations, should notify the
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Contact Person listed below in advance
of the meeting.
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is
hereby given of the following meetings.
The meetings 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: Center for Scientific
Review Special Emphasis Panel, PAR Panel:
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]]>Agencies
[Federal Register Volume 76, Number 239 (Tuesday, December 13, 2011)]
[Notices]
[Pages 77543-77544]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-31929]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Clinical Center; Notice of Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended (5 U.S.C. App.), notice is hereby given of a meeting of the NIH
Advisory Board for Clinical Research.
The meeting will be open to the public as indicated below, with
attendance limited to space available. Individuals who plan to attend
and need special assistance, such as sign language interpretation or
other reasonable accommodations, should notify the Contact Person
listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended
to discuss personnel matters, the disclosure of which would constitute
a clearly unwarranted invasion of privacy.
Name of Committee: NIH Advisory Board for Clinical Research.
Date: January 30, 2012.
Time: 10 a.m. to 1:15 p.m.
Agenda: To review the 2012 Clinical Center Strategic and Annual
Operating Plan and provide updates on selected organizational
initiatives.
Place: National Institutes of Health, Building 10, 10 Center
Drive, CRC Medical Board Room 4-2551, Bethesda, MD 20892.
Closed: 1:15 p.m. to 2 p.m.
Agenda: To review and evaluate to discuss personnel matters.
Place: National Institutes of Health, Building 10, 10 Center
Drive, CRC Medical Board Room 4-2551, Bethesda, MD 20892.
Contact Person: Maureen E Gormley, Executive Secretary, Mark O.
Hatfield
[[Page 77544]]
Clinical Research Center, National Institutes of Health, Building
10, Room 6-2551, Bethesda, MD 20892, (301) 496-2897.
Any interested person may file written comments with the committee
by forwarding the statement to the Contact Person listed on this
notice. The statement should include the name, address, telephone
number and when applicable, the business or professional affiliation
of the interested person.
In the interest of security, NIH has instituted stringent
procedures for entrance onto the NIH campus. All visitor vehicles,
including taxicabs, hotel, and airport shuttles will be inspected
before being allowed on campus. Visitors will be asked to show one
form of identification (for example, a government-issued photo ID,
driver's license, or passport) and to state the purpose of their
visit.
Dated: December 6, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-31929 Filed 12-12-11; 8:45 am]
BILLING CODE 4140-01-P
