National Library of Medicine Notice of Meeting, 51994 [2011-21238]
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51994
Federal Register / Vol. 76, No. 161 / Friday, August 19, 2011 / Notices
jlentini on DSK4TPTVN1PROD with NOTICES
the Committee on Health, Education,
Labor, and Pensions of the Senate and
the Chairman of the Committee on
Energy and Commerce of the House of
Representatives, as set forth in the
Congressional Record).1 This draft
guidance addresses one of these goals
with the creation of a guidance
document that addresses the ‘‘imaging
standards for use as an endpoint in
clinical trials.’’ This draft guidance also
follows the April 13, 2010, public
workshop ‘‘Standards for Imaging
Endpoints in Clinical Trials’’
cosponsored by FDA, the Society of
Nuclear Medicine, and the Radiological
Society of North America.2
This draft guidance outlines the major
considerations for standardization of
image acquisition, image interpretation
methods, and other procedures to help
ensure imaging data quality. The draft
guidance describes two categories of
image acquisition and interpretation
standardization, a medical practice
standard and a clinical trial standard,
and provides guidance on the role of
each standard in a clinical trial. With a
medical practice standard, the image
acquisition and interpretation methods
in the trial do not exceed those used in
medical practice. In contrast, a clinical
trial standard involves imaging methods
that exceed those used in medical
practice. The draft guidance focuses on
the methods important for image
acquisition and interpretation and
provides a detailed outline of other
procedures important for optimizing
clinical trial imaging data quality.
This draft guidance is being issued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The draft guidance, when finalized, will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 standards for clinical trial imaging
endpoints. 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. The 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This draft guidance refers to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
1 See ‘‘Section A: PDUFA Reauthorization
Performance Goals and Procedures Fiscal Years
2008 Through 2012’’ (https://www.fda.gov/
ForIndustry/UserFees/PrescriptionDrugUserFee/
ucm119243.htm).
2 See https://www.rsna.org/snm/.
VerDate Mar<15>2010
18:32 Aug 18, 2011
Jkt 223001
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
III. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) either electronic or written
comments regarding this document. It is
only necessary to 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. Received
comments may be seen in the Division
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 https://
www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, or https://www.
egulations.gov.
Dated: August 15, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–21244 Filed 8–18–11; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Library of Medicine Notice of
Meeting
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 Board
of Scientific Counselors, National
Center for Biotechnology Information.
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 as indicated below in accordance
with the provisions set forth in section
552b(c)(6), Title 5 U.S.C., as amended
for review, discussion, and evaluation of
individual intramural programs and
projects conducted by the National
Library of Medicine, including
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consideration of personnel
qualifications and performance, and the
competence of individual investigators,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Board of Scientific
Counselors, National Center for
Biotechnology Information.
Date: November 8, 2011.
Open: 8:30 am to 12:00 pm.
Agenda: Program Discussion.
Place: National Library of Medicine,
Building 38, 2nd Floor, Board Room, 8600
Rockville Pike, Bethesda, MD. 20892.
Closed: 12:00 pm to 2:00 pm.
Agenda: To review and evaluate personal
qualifications and performance, and
competence of individual investigators.
Place: National Library of Medicine,
Building 38, 2nd Floor, Board, Room, 8600
Rockville Pike, Bethesda, MD 20892.
Open: 2:00 pm to 3:00 pm.
Agenda: Program Discussion.
Place: National Library of Medicine,
Building 38, 2nd Floor, Board Room, 8600
Rockville Pike, Bethesda, MD 20892.
Contact Person: David J. Lipman, MD,
Director, National Center of Biotechnology
Information, National Library of Medicine,
Department of Health and Human Services,
Building 38A, Room 8N805, Bethesda, MD
20892, 301–435–5985,
dlipman@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 No. 93.879, Medical Library
Assistance, National Institutes of Health,
HHS).
Dated: August 15, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–21238 Filed 8–18–11; 8:45 am]
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[Federal Register Volume 76, Number 161 (Friday, August 19, 2011)]
[Notices]
[Page 51994]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21238]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
National Library of Medicine Notice of Meeting
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
Board of Scientific Counselors, National Center for Biotechnology
Information.
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 as indicated below in
accordance with the provisions set forth in section 552b(c)(6), Title 5
U.S.C., as amended for review, discussion, and evaluation of individual
intramural programs and projects conducted by the National Library of
Medicine, including consideration of personnel qualifications and
performance, and the competence of individual investigators, the
disclosure of which would constitute a clearly unwarranted invasion of
personal privacy.
Name of Committee: Board of Scientific Counselors, National
Center for Biotechnology Information.
Date: November 8, 2011.
Open: 8:30 am to 12:00 pm.
Agenda: Program Discussion.
Place: National Library of Medicine, Building 38, 2nd Floor,
Board Room, 8600 Rockville Pike, Bethesda, MD. 20892.
Closed: 12:00 pm to 2:00 pm.
Agenda: To review and evaluate personal qualifications and
performance, and competence of individual investigators.
Place: National Library of Medicine, Building 38, 2nd Floor,
Board, Room, 8600 Rockville Pike, Bethesda, MD 20892.
Open: 2:00 pm to 3:00 pm.
Agenda: Program Discussion.
Place: National Library of Medicine, Building 38, 2nd Floor,
Board Room, 8600 Rockville Pike, Bethesda, MD 20892.
Contact Person: David J. Lipman, MD, Director, National Center
of Biotechnology Information, National Library of Medicine,
Department of Health and Human Services, Building 38A, Room 8N805,
Bethesda, MD 20892, 301-435-5985, dlipman@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 No. 93.879,
Medical Library Assistance, National Institutes of Health, HHS).
Dated: August 15, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2011-21238 Filed 8-18-11; 8:45 am]
BILLING CODE 4140-01-P
