80 FR 13863 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health

Federal Register Volume 80, Issue 51 (March 17, 2015)

Page Range		13863-13864
FR Document		2015-06036

Federal Register, Volume 80 Issue 51 (Tuesday, March 17, 2015)

[Federal Register Volume 80, Number 51 (Tuesday, March 17, 2015)]
[Notices]
[Pages 13863-13864]
From the Federal Register Online  [www.thefederalregister.org]
[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, [email protected].

    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, [email protected].

    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, [email protected].

    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]
 BILLING CODE 4140-01-P

Federal Register / Vol. 80, No. 51 / Tuesday, March 17, 2015 / Notices 13863

DEPARTMENT OF HEALTH AND notify the Contact Person listed below The meeting will be closed to the
HUMAN SERVICES in advance of the meeting. public in accordance with the
The meeting will be closed to the provisions set forth in sections
National Institutes of Health public in accordance with the 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
provisions set forth in sections as amended. The grant applications and
National Heart, Lung, and Blood; 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., the discussions could disclose
Institute Notice of Meeting as amended. The grant applications confidential trade secrets or commercial
Pursuant to section 10(a) of the and/or contract proposals and the property such as patentable material,
Federal Advisory Committee Act, as discussions could disclose confidential and personal information concerning
amended (5 U.S.C. App.), notice is trade secrets or commercial property individuals associated with the grant
hereby given of a meeting of the Sickle such as patentable material, and applications, the disclosure of which
Cell Disease Advisory Committee. personal information concerning would constitute a clearly unwarranted
The meeting will be open to the individuals associated with the grant invasion of personal privacy.
public, with attendance limited to space applications and/or contract proposals,
Name of Committee: National Heart, Lung,
available. Individuals who plan to the disclosure of which would and Blood Institute Special Emphasis Panel;
attend and need special assistance, such constitute a clearly unwarranted Technologies to Assess Sleep Health Status
as sign language interpretation or other invasion of personal privacy. in Populations.
reasonable accommodations, should Name of Committee: National Advisory Date: April 10, 2015.
notify the Contact Person listed below Council for Biomedical Imaging and Time: 2:00 p.m. to 5:00 p.m.
in advance of the meeting. Bioengineering. Agenda: To review and evaluate grant
Date: May 18, 2015. applications.
Name of Committee: Sickle Cell Disease Open: 9:00 a.m. to 12:30 p.m. Place: National Institutes of Health, 6701
Advisory Committee. Agenda: Report from the Institute Director, Rockledge Drive, Suite 7182, Bethesda, MD
Date: April 22, 2015. other Institute Staff, scientific presentations, 20892 (Telephone Conference Call).
Time: 8:00 a.m. to 4:00 p.m. and presentations of task force reports. Contact Person: Susan Wohler Sunnarborg,
Agenda: Discussion of Programs. Place: The William F. Bolger Center, Ph.D., Scientific Review Officer, Office of
Place: National Institutes of Health, 6701 Franklin Building, Classroom 1, 9600 Scientific Review/DERA National, Heart,
Rockledge Drive, 9th Floor, Room 9100/9104, Newbridge Drive, Potomac, MD 20854. Lung, and Blood Institute, 6701 Rockledge
Bethesda, MD 20892. Closed: 1:30 p.m. to 4:00 p.m. Drive, Room 7182, Bethesda, MD 20892,
Contact Person: W. Keith Hoots, MD, Agenda: To review and evaluate grant sunnarborgsw@nhlbi.nih.gov.
Director, Division of Blood Diseases and applications and/or proposals.
Resources, National Heart, Lung, and Blood (Catalogue of Federal Domestic Assistance
Place: The William F. Bolger Center, Program Nos. 93.233, National Center for
Institute, 6701 Rockledge Drive, Suite 9030, Franklin Building, Classroom 1, 9600
Bethesda, MD 20892, 301–435–0080 Sleep Disorders Research; 93.837, Heart and
Newbridge Drive, Potomac, MD 20854. Vascular Diseases Research; 93.838, Lung
hootswk@nhlbi.nih.gov. Contact Person: Jill Heemskerk, Ph.D., Diseases Research; 93.839, Blood Diseases
(Catalogue of Federal Domestic Assistance Executive Secretary, Office of Research
and Resources Research, National Institutes
Program Nos. 93.233, National Center for Administration, National Institute of
of Health, HHS)
Sleep Disorders Research; 93.837, Heart and Biomedical Imaging and Bioengineering,
Vascular Diseases Research; 93.838, Lung 6707 Democracy Boulevard, Room 239, Dated: March 11, 2015.
Diseases Research; 93.839, Blood Diseases Bethesda, MD 20892. Michelle Trout,
and Resources Research, National Institutes Any interested person may file written
Program Analyst, Office of Federal Advisory
of Health, HHS) comments with the committee by forwarding
Committee Policy.
the statement to the Contact Person listed on
Dated: March 11, 2015. this notice. The statement should include the [FR Doc. 2015–05971 Filed 3–16–15; 8:45 am]
Michelle Trout, Program Analyst, name, address, telephone number and when BILLING CODE 4140–01–P
applicable, the business or professional
Office of Federal Advisory Committee Policy.
affiliation of the interested person.
[FR Doc. 2015–05970 Filed 3–16–15; 8:45 am] Information is also available on the DEPARTMENT OF HEALTH AND
BILLING CODE 4140–01–P Institute’s/Center’s home page: http:// HUMAN SERVICES
www.nibib1.nih.gov/about/NACBIB/
NACBIB.htm, where an agenda and any National Institutes of Health
DEPARTMENT OF HEALTH AND additional information for the meeting will
HUMAN SERVICES be posted when available. Center for Scientific Review; Notice of
Dated: March 11, 2015. Closed Meetings
National Institutes of Health David Clary,
Program Analyst, Office of Federal Advisory Pursuant to section 10(d) of the
National Institute of Biomedical Committee Policy. Federal Advisory Committee Act, as
Imaging and Bioengineering; Notice of amended (5 U.S.C. App.), notice is
[FR Doc. 2015–05974 Filed 3–16–15; 8:45 am]
Meeting hereby given of the following meetings.
BILLING CODE 4140–01–P
Pursuant to section 10(d) of the The meetings will be closed to the
Federal Advisory Committee Act, as public in accordance with the
amended (5 U.S.C. App.), notice is DEPARTMENT OF HEALTH AND provisions set forth in sections
hereby given of a meeting of the HUMAN SERVICES 552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
National Advisory Council for as amended. The grant applications and
National Institutes of Health
mstockstill on DSK4VPTVN1PROD with NOTICES

Biomedical Imaging and Bioengineering. the discussions could disclose
The meeting will be open to the confidential trade secrets or commercial
National Heart, Lung, and Blood
public as indicated below, with property such as patentable material,
Institute; Notice of Closed Meeting
attendance limited to space available. and personal information concerning
Individuals who plan to attend and Pursuant to section 10(d) of the individuals associated with the grant
need special assistance, such as sign Federal Advisory Committee Act, as applications, the disclosure of which
language interpretation or other amended (5 U.S.C. App.), notice is would constitute a clearly unwarranted
reasonable accommodations, should hereby given of the following meeting. 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 DEPARTMENT OF HEALTH AND 10903 New Hampshire Ave. Bldg. 71,
Review Special Emphasis Panel; AIDS and HUMAN SERVICES Rm. 3128, Silver Spring, MD 20993–
AIDS Related Research. 0002. Send one self-addressed adhesive
Date: March 18, 2015. Food and Drug Administration label to assist that office in processing
Time: 11:00 a.m. to 5:00 p.m.
[Docket No. FDA–2011–D–0293] your request.
Agenda: To review and evaluate grant
applications.
Submit electronic comments on the
Place: National Institutes of Health, 6701 Reprocessing Medical Devices in guidance to http://www.regulations.gov.
Rockledge Drive, Bethesda, MD 20892, Health Care Settings: Validation Submit written comments to the
(Telephone Conference Call). Methods and Labeling; Guidance for Division of Dockets Management (HFA–
Contact Person: Jose H Guerrier, Ph.D., Industry and Food and Drug 305), Food and Drug Administration,
Scientific Review Officer, Center for Administration Staff; Availability 5630 Fishers Lane, Rm. 1061, Rockville,
Scientific Review, National Institutes of MD 20852. Identify comments with the
Health, 6701 Rockledge Drive, Room 5218, AGENCY: Food and Drug Administration, docket number found in brackets in the
MSC 7852, Bethesda, MD 20892, 301–435– HHS. heading of this document.
1137, guerriej@csr.nih.gov. ACTION: Notice. FOR FURTHER INFORMATION CONTACT:
This notice is being published less than 15
Angela C. Krueger, Center for Devices
days prior to the meeting due to the timing SUMMARY: The Food and Drug
limitations imposed by the review and and Radiological Health, Food and Drug
Administration (FDA) is announcing the
funding cycle. Administration, 10903 New Hampshire
availability of the guidance entitled
Name of Committee: Center for Scientific Ave., Bldg. 66, Rm. 1666, Silver Spring,
‘‘Reprocessing Medical Devices in
Review Special Emphasis Panel; Small MD 20993–0002, 301–796–6380; or
Health Care Settings: Validation
Business: Respiratory Sciences Special Panel. Stephen Ripley, Center for Biologics
Methods and Labeling.’’ This guidance
Date: March 19–20, 2015. Evaluation and Research, Food and
Time: 9:00 a.m. to 5:00 p.m. provides recommendations for the
Drug Administration, 10903 New
Agenda: To review and evaluate grant formulation and scientific validation of
Hampshire Ave. Bldg. 71, Rm. 7301,
applications. reprocessing instructions for reusable
Silver Spring, MD 20993, 240–402–
Place: National Institutes of Health, One medical devices. This guidance
7911.
Democracy Plaza, 6701 Democracy document also provides
Boulevard, Bethesda, MD 20892, (Virtual recommendations for the content and SUPPLEMENTARY INFORMATION:
Meeting). review procedures for premarket
Contact Person: Lawrence E Boerboom, I. Background
notification (510(k)) submissions,
Ph.D., Chief, CVRS IRG, Center for Scientific
premarket approval (PMA) applications, In recent years, there has been a
Review, National Institutes of Health, 6701 significant advance in knowledge and
Rockledge Drive, Room 4130, MSC 7814,
humanitarian device exemption (HDE)
applications, de novo requests, and technology involved in reprocessing
Bethesda, MD 20892, (301) 435–8367, reusable medical devices. Additionally,
boerboom@nih.gov. investigational device exemption (IDE)
applications, concerning the labeling there has been an evolution towards
This notice is being published less than 15 more complex medical device designs
days prior to the meeting due to the timing instructions for reprocessing reusable
medical devices. This guidance reflects that are more difficult to clean,
limitations imposed by the review and
funding cycle. the scientific advances in knowledge disinfect, and sterilize. This guidance
Name of Committee: Center for Scientific and technology involved in reprocessing reflects the scientific advances in these
Review Special Emphasis Panel; Member reusable medical devices, especially areas. Under section 502(f) of the
Conflict: Respiratory Sciences Special Panel. more complex, reusable medical device Federal Food, Drug, and Cosmetic Act
Date: March 24–25, 2015. designs that are more difficult to (21 U.S.C. 352(f)), a device must have
Time: 9:00 a.m. to 5:00 p.m. reprocess. adequate directions for use, which
Agenda: To review and evaluate grant include instructions on preparing a
applications. DATES: Submit either electronic or device for use. Instructions on how to
Place: National Institutes of Health, 6701 written comments on this guidance at reprocess (i.e., clean, disinfect, and
Rockledge Drive, Bethesda, MD 20892, any time. General comments on Agency sterilize) a reusable device are critical to
(Virtual Meeting). guidance documents are welcome at any
Contact Person: Lawrence E Boerboom,
ensure that the device is appropriately
time. prepared for its next use.
Ph.D., Chief, CVRS IRG, Center for Scientific
Review, National Institutes of Health, 6701 ADDRESSES: An electronic copy of the In the Federal Register of May 2, 2011
Rockledge Drive, Room 4130, MSC 7814, guidance document is available for (76 FR 24494), FDA announced the
Bethesda, MD 20892, (301) 435–8367, download from the Internet. See the availability of the draft guidance.
boerboom@nih.gov. SUPPLEMENTARY INFORMATION section for Interested persons were invited to
This notice is being published less than 15 information on electronic access to the comment by August 1, 2011. FDA
days prior to the meeting due to the timing guidance. Submit written requests for a reviewed and considered all the public
limitations imposed by the review and single hard copy of the guidance comments we received and revised
funding cycle. document entitled ‘‘Reprocessing several sections of the guidance, where
(Catalogue of Federal Domestic Assistance Medical Devices in Health Care Settings: applicable. On June 8 and 9, 2011, FDA
Program Nos. 93.306, Comparative Medicine; Validation Methods and Labeling’’ to held a public workshop entitled
93.333, Clinical Research, 93.306, 93.333, the Office of the Center Director, ‘‘Reprocessing of Reusable Medical
93.337, 93.393–93.396, 93.837–93.844,
Guidance and Policy Development, Devices Workshop.’’ The purpose of the
93.846–93.878, 93.892, 93.893, National
mstockstill on DSK4VPTVN1PROD with NOTICES

Institutes of Health, HHS) Center for Devices and Radiological workshop was to discuss factors
Health, Food and Drug Administration, affecting the reprocessing of reusable
Dated: March 11, 2015. 10903 New Hampshire Ave. Bldg. 66, medical devices and FDA’s plans to
David Clary, Rm. 5431, Silver Spring, MD 20993– address the identified issues. The
Program Analyst, Office of Federal Advisory 0002; or the Office of Communication, discussion during this workshop and
Committee Policy. Outreach and Development, Center for the comments received were considered
[FR Doc. 2015–06036 Filed 3–16–15; 8:45 am] Biologics Evaluation and Research before revising the guidance. This final
BILLING CODE 4140–01–P (CBER), Food and Drug Administration, guidance supersedes ‘‘Labeling Reusable

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Document Created: 2015-12-18 12:01:56
Document Modified: 2015-12-18 12:01:56

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Dates		March 18, 2015.
FR Citation		80 FR 13863

80 FR 13863 - Center for Scientific Review; Notice of Closed Meetings

DEPARTMENT OF HEALTH AND HUMAN SERVICESNational Institutes of Health

Federal Register Volume 80, Issue 51 (March 17, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health