Center for Scientific Review; Notice of Closed Meetings, 13863-13864 [2015-06036]
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Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood;
Institute 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 Sickle
Cell Disease Advisory Committee.
The meeting will be open to the
public, 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.
Name of Committee: Sickle Cell Disease
Advisory Committee.
Date: April 22, 2015.
Time: 8:00 a.m. to 4:00 p.m.
Agenda: Discussion of Programs.
Place: National Institutes of Health, 6701
Rockledge Drive, 9th Floor, Room 9100/9104,
Bethesda, MD 20892.
Contact Person: W. Keith Hoots, MD,
Director, Division of Blood Diseases and
Resources, National Heart, Lung, and Blood
Institute, 6701 Rockledge Drive, Suite 9030,
Bethesda, MD 20892, 301–435–0080
hootswk@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: March 11, 2015.
Michelle Trout, Program Analyst,
Office of Federal Advisory Committee Policy.
[FR Doc. 2015–05970 Filed 3–16–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
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National Institute of Biomedical
Imaging and Bioengineering; 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 Advisory Council for
Biomedical Imaging and Bioengineering.
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
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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/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Council for Biomedical Imaging and
Bioengineering.
Date: May 18, 2015.
Open: 9:00 a.m. to 12:30 p.m.
Agenda: Report from the Institute Director,
other Institute Staff, scientific presentations,
and presentations of task force reports.
Place: The William F. Bolger Center,
Franklin Building, Classroom 1, 9600
Newbridge Drive, Potomac, MD 20854.
Closed: 1:30 p.m. to 4:00 p.m.
Agenda: To review and evaluate grant
applications and/or proposals.
Place: The William F. Bolger Center,
Franklin Building, Classroom 1, 9600
Newbridge Drive, Potomac, MD 20854.
Contact Person: Jill Heemskerk, Ph.D.,
Executive Secretary, Office of Research
Administration, National Institute of
Biomedical Imaging and Bioengineering,
6707 Democracy Boulevard, Room 239,
Bethesda, MD 20892.
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.
Information is also available on the
Institute’s/Center’s home page: https://
www.nibib1.nih.gov/about/NACBIB/
NACBIB.htm, where an agenda and any
additional information for the meeting will
be posted when available.
Dated: March 11, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–05974 Filed 3–16–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; Notice of Closed 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 meeting.
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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 Heart, Lung,
and Blood Institute Special Emphasis Panel;
Technologies to Assess Sleep Health Status
in Populations.
Date: April 10, 2015.
Time: 2:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Suite 7182, Bethesda, MD
20892 (Telephone Conference Call).
Contact Person: Susan Wohler Sunnarborg,
Ph.D., Scientific Review Officer, Office of
Scientific Review/DERA National, Heart,
Lung, and Blood Institute, 6701 Rockledge
Drive, Room 7182, Bethesda, MD 20892,
sunnarborgsw@nhlbi.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
Dated: March 11, 2015.
Michelle Trout,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–05971 Filed 3–16–15; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
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.
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13864
Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices
Name of Committee: Center for Scientific
Review Special Emphasis Panel; AIDS and
AIDS Related Research.
Date: March 18, 2015.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Telephone Conference Call).
Contact Person: Jose H Guerrier, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218,
MSC 7852, Bethesda, MD 20892, 301–435–
1137, guerriej@csr.nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Small
Business: Respiratory Sciences Special Panel.
Date: March 19–20, 2015.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, One
Democracy Plaza, 6701 Democracy
Boulevard, Bethesda, MD 20892, (Virtual
Meeting).
Contact Person: Lawrence E Boerboom,
Ph.D., Chief, CVRS IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 4130, MSC 7814,
Bethesda, MD 20892, (301) 435–8367,
boerboom@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific
Review Special Emphasis Panel; Member
Conflict: Respiratory Sciences Special Panel.
Date: March 24–25, 2015.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, 6701
Rockledge Drive, Bethesda, MD 20892,
(Virtual Meeting).
Contact Person: Lawrence E Boerboom,
Ph.D., Chief, CVRS IRG, Center for Scientific
Review, National Institutes of Health, 6701
Rockledge Drive, Room 4130, MSC 7814,
Bethesda, MD 20892, (301) 435–8367,
boerboom@nih.gov.
This notice is being published less than 15
days prior to the meeting due to the timing
limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: March 11, 2015.
David Clary,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2015–06036 Filed 3–16–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–D–0293]
Reprocessing Medical Devices in
Health Care Settings: Validation
Methods and Labeling; Guidance for
Industry and Food and Drug
Administration Staff; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of the guidance entitled
‘‘Reprocessing Medical Devices in
Health Care Settings: Validation
Methods and Labeling.’’ This guidance
provides recommendations for the
formulation and scientific validation of
reprocessing instructions for reusable
medical devices. This guidance
document also provides
recommendations for the content and
review procedures for premarket
notification (510(k)) submissions,
premarket approval (PMA) applications,
humanitarian device exemption (HDE)
applications, de novo requests, and
investigational device exemption (IDE)
applications, concerning the labeling
instructions for reprocessing reusable
medical devices. This guidance reflects
the scientific advances in knowledge
and technology involved in reprocessing
reusable medical devices, especially
more complex, reusable medical device
designs that are more difficult to
reprocess.
SUMMARY:
Submit either electronic or
written comments on this guidance at
any time. General comments on Agency
guidance documents are welcome at any
time.
ADDRESSES: An electronic copy of the
guidance document is available for
download from the Internet. See the
SUPPLEMENTARY INFORMATION section for
information on electronic access to the
guidance. Submit written requests for a
single hard copy of the guidance
document entitled ‘‘Reprocessing
Medical Devices in Health Care Settings:
Validation Methods and Labeling’’ to
the Office of the Center Director,
Guidance and Policy Development,
Center for Devices and Radiological
Health, Food and Drug Administration,
10903 New Hampshire Ave. Bldg. 66,
Rm. 5431, Silver Spring, MD 20993–
0002; or the Office of Communication,
Outreach and Development, Center for
Biologics Evaluation and Research
(CBER), Food and Drug Administration,
DATES:
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10903 New Hampshire Ave. Bldg. 71,
Rm. 3128, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your request.
Submit electronic comments on the
guidance to https://www.regulations.gov.
Submit written comments to the
Division of Dockets Management (HFA–
305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville,
MD 20852. Identify comments with the
docket number found in brackets in the
heading of this document.
FOR FURTHER INFORMATION CONTACT:
Angela C. Krueger, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring,
MD 20993–0002, 301–796–6380; or
Stephen Ripley, Center for Biologics
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave. Bldg. 71, Rm. 7301,
Silver Spring, MD 20993, 240–402–
7911.
SUPPLEMENTARY INFORMATION:
I. Background
In recent years, there has been a
significant advance in knowledge and
technology involved in reprocessing
reusable medical devices. Additionally,
there has been an evolution towards
more complex medical device designs
that are more difficult to clean,
disinfect, and sterilize. This guidance
reflects the scientific advances in these
areas. Under section 502(f) of the
Federal Food, Drug, and Cosmetic Act
(21 U.S.C. 352(f)), a device must have
adequate directions for use, which
include instructions on preparing a
device for use. Instructions on how to
reprocess (i.e., clean, disinfect, and
sterilize) a reusable device are critical to
ensure that the device is appropriately
prepared for its next use.
In the Federal Register of May 2, 2011
(76 FR 24494), FDA announced the
availability of the draft guidance.
Interested persons were invited to
comment by August 1, 2011. FDA
reviewed and considered all the public
comments we received and revised
several sections of the guidance, where
applicable. On June 8 and 9, 2011, FDA
held a public workshop entitled
‘‘Reprocessing of Reusable Medical
Devices Workshop.’’ The purpose of the
workshop was to discuss factors
affecting the reprocessing of reusable
medical devices and FDA’s plans to
address the identified issues. The
discussion during this workshop and
the comments received were considered
before revising the guidance. This final
guidance supersedes ‘‘Labeling Reusable
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[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13863-13864]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-06036]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meetings
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.
[[Page 13864]]
Name of Committee: Center for Scientific Review Special Emphasis
Panel; AIDS and AIDS Related Research.
Date: March 18, 2015.
Time: 11:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Telephone Conference Call).
Contact Person: Jose H Guerrier, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5218, MSC 7852, Bethesda, MD
20892, 301-435-1137, guerriej@csr.nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Small Business: Respiratory Sciences Special Panel.
Date: March 19-20, 2015.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, One Democracy Plaza, 6701
Democracy Boulevard, Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Lawrence E Boerboom, Ph.D., Chief, CVRS IRG,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4130, MSC 7814, Bethesda, MD 20892, (301) 435-
8367, boerboom@nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Member Conflict: Respiratory Sciences Special Panel.
Date: March 24-25, 2015.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, 6701 Rockledge Drive,
Bethesda, MD 20892, (Virtual Meeting).
Contact Person: Lawrence E Boerboom, Ph.D., Chief, CVRS IRG,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4130, MSC 7814, Bethesda, MD 20892, (301) 435-
8367, boerboom@nih.gov.
This notice is being published less than 15 days prior to the
meeting due to the timing limitations imposed by the review and
funding cycle.
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
Dated: March 11, 2015.
David Clary,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-06036 Filed 3-16-15; 8:45 am]
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