Center for Scientific Review; Notice of Closed Meetings, 28526-28527 [2014-11246]
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28526
Federal Register / Vol. 79, No. 95 / Friday, May 16, 2014 / Notices
Dated: May 12, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
include the FDA docket number found
in brackets in the heading of this
document.
[FR Doc. 2014–11322 Filed 5–15–14; 8:45 am]
FOR FURTHER INFORMATION CONTACT:
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0360]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Food and Drug
Administration Safety Communication
Readership Survey
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by June 16,
2014.
SUMMARY:
To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0341. Also
ADDRESSES:
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 1350 Piccard
Dr., PI50–400B, Rockville, MD 20850,
PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
FDA Safety Communication (Formerly
Known as Public Health Notification)
Readership Survey—(OMB Control
Number 0910–0341)—(Extension)
Section 705(b) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C.
375(b)) gives FDA authority to
disseminate information concerning
suspected or imminent danger to public
health by any regulated product. Section
1701(a)(4) of the Public Health Service
Act (42 U.S.C. 300u(a)(4)) also
authorizes FDA to conduct research
relating to health information.
FDA’s Center for Devices and
Radiological Health (CDRH) carries out
FDA’s regulatory responsibilities
regarding medical devices and
radiological products. CDRH must be
able to effectively communicate risk to
health care practitioners, patients,
caregivers, and consumers when there is
a real or suspected threat to the public’s
health. CDRH uses safety
communications to transmit information
concerning these risks to user
communities. Safety communications
are released and available to
organizations such as hospitals, nursing
homes, hospices, home health care
agencies, manufacturers, retail
pharmacies, and other health care
providers, as well as patients,
caregivers, consumers, and patient
advocacy groups. Through a process for
identifying and addressing postmarket
safety issues related to regulated
products, CDRH determines when to
release safety communications.
FDA seeks to evaluate the clarity,
timeliness, and impact of safety
communications by surveying a sample
of recipients to determine the impact of
safety communications on the
knowledge of the recipients.
Understanding how the target audiences
view these publications will aid in
determining what, if any, changes
should be considered in their content,
format, and method of dissemination.
The collection of this data is an
important step in determining how well
CDRH is communicating risk. The
results from this survey will emphasize
the quality of the safety
communications and customer
satisfaction. This will enable us to better
serve the public by improving the
effectiveness of safety communications.
We updated the title of the survey
from ‘‘FDA Public Health Notification
Readership Survey’’ to ‘‘FDA Safety
Communication Readership Survey’’ to
accurately reflect the information that is
being collected.
In the Federal Register of February
10, 2014 (79 FR 7677), FDA published
a 60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity
Number of
respondents
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
Public Health Notification Readership Survey .....................
300
3
900
0.17
153
EMCDONALD on DSK67QTVN1PROD with NOTICES
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
Based on the history of the Safety
Communication program, it is estimated
that an average of 3 collections will be
conducted per year. The total burden of
response time is estimated at 10 minutes
per survey. This was derived by CDRH
staff completing the survey.
Dated: May 12, 2014.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014–11326 Filed 5–15–14; 8:45 am]
BILLING CODE 4160–01–P
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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Federal Register / Vol. 79, No. 95 / Friday, May 16, 2014 / Notices
EMCDONALD on DSK67QTVN1PROD with NOTICES
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: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Synthetic and Biological
Chemistry A Study Section.
Date: June 9–10, 2014.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency Bethesda, One
Bethesda Metro Center, 7400 Wisconsin
Avenue, Bethesda, MD 20814.
Contact Person: Mike Radtke, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4176,
MSC 7806, Bethesda, MD 20892, 301–435–
1728, radtkem@csr.nih.gov.
Name of Committee: Biological Chemistry
and Macromolecular Biophysics Integrated
Review Group; Macromolecular Structure
and Function A Study Section.
Date: June 10–11, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Renaissance Washington DC,
Dupont Circle, 1143 New Hampshire Avenue
NW, Washington, DC 20037.
Contact Person: Nitsa Rosenzweig, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4152,
MSC 7760, Bethesda, MD 20892, (301) 404–
7419, rosenzweign@csr.nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group;
Oral, Dental and Craniofacial Sciences Study
Section.
Date: June 11, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suites Washington DC,
Convention Center, 900 10th Street NW.,
Washington, DC 20001.
Contact Person: Yi-Hsin Liu, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4214,
MSC 7814, Bethesda, MD 20892, 301–435–
1781, liuyh@csr.nih.gov
Name of Committee: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group; Neurobiology of
Learning and Memory Study Section.
Date: June 11, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
VerDate Mar<15>2010
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Place: Embassy Suites at the Chevy Chase
Pavilion, 4300 Military Road, NW,
Washington, DC 20015.
Contact Person: Wei-Qin Zhao, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive Room 5181
MSC 7846, Bethesda, MD 20892–7846, 301–
435–1236, zhaow@csr.nih.gov.
Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Dissemination and Implementation Research
in Health Study Section.
Date: June 11–12, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Woodland Hills/Los Angeles,
6360 Canoga Avenue, Woodland Hills, CA
91367.
Contact Person: Martha L Hare, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3154,
Bethesda, MD 20892, (301) 451–8504,
harem@mail.nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group; Cellular
Aspects of Diabetes and Obesity Study
Section.
Date: June 11–12, 2014.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hotel Nikko San Francisco, 222
Mason Street, San Francisco, CA 94102.
Contact Person: Robert Garofalo, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institute of
Health, 6701 Rockledge Drive, Room 6156,
MSC 7892, Bethesda, MD, 20892, 301–435–
1043, garofalors@csr.nih.gov.
Name of Committee: Oncology 1-Basic
Translational Integrated Review Group;
Cancer Genetics Study Section.
Date: June 11, 2014.
Time: 8:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: St. Gregory Hotel, 2033 M Street,
NW, Washington, DC 20036.
Contact Person: Michael L Bloom, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6187,
MSC 7804, Bethesda, MD 20892, 301–451–
0132, bloomm2@mail.nih.gov.
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Neural Basis of Psychopathology,
Addictions and Sleep Disorders Study
Section.
Date: June 11, 2014.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Residence Inn Bethesda, 7335
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Boris P. Sokolov, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A,
MSC 7846, Bethesda, MD 20892, 301–408–
9115, bsokolov@csr.nih.gov.
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28527
Name of Committee: Brain Disorders and
Clinical Neuroscience Integrated Review
Group; Acute Neural Injury and Epilepsy
Study Section.
Date: June 11, 2014.
Time: 8:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: Embassy Suite DC Convention
Center, 900 10th Street NW., Washington, DC
20001.
Contact Person: Seetha Bhagavan, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194,
MSC 7846, Bethesda, MD 20892, (301) 237–
9838, bhagavas@csr.nih.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Kidney, Nutrition, Obesity and Diabetes
Study Section.
Date: June 11–12, 2014.
Time: 8:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Sir Francis Drake Hotel, 450 Powell
Street at Sutter, San Francisco, CA 94102.
Contact Person: Fungai Chanetsa, Ph.D.,
MPH, Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3135,
MSC 7770, Bethesda, MD 20892, 301–408–
9436, fungai.chanetsa@nih.hhs.gov.
Name of Committee: Population Sciences
and Epidemiology Integrated Review Group;
Societal and Ethical Issues in Research Study
Section.
Date: June 11, 2014.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hilton Garden Inn Bethesda, 7301
Waverly Street, Bethesda, MD 20814.
Contact Person: Karin F. Helmers, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3144,
MSC 7770, Bethesda, MD 20892, (301) 254–
9975, helmersk@csr.nih.gov.
(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: May 12, 2014.
Anna Snouffer,
Deputy Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2014–11246 Filed 5–15–14; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute of Diabetes and
Digestive and Kidney Diseases; Notice
of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
E:\FR\FM\16MYN1.SGM
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]]>Agencies
[Federal Register Volume 79, Number 95 (Friday, May 16, 2014)]
[Notices]
[Pages 28526-28527]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-11246]
-----------------------------------------------------------------------
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
[[Page 28527]]
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: Biological Chemistry and Macromolecular
Biophysics Integrated Review Group; Synthetic and Biological
Chemistry A Study Section.
Date: June 9-10, 2014.
Time: 8:00 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hyatt Regency Bethesda, One Bethesda Metro Center, 7400
Wisconsin Avenue, Bethesda, MD 20814.
Contact Person: Mike Radtke, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4176, MSC 7806, Bethesda, MD 20892, 301-435-
1728, radtkem@csr.nih.gov.
Name of Committee: Biological Chemistry and Macromolecular
Biophysics Integrated Review Group; Macromolecular Structure and
Function A Study Section.
Date: June 10-11, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Renaissance Washington DC, Dupont Circle, 1143 New
Hampshire Avenue NW, Washington, DC 20037.
Contact Person: Nitsa Rosenzweig, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4152, MSC 7760, Bethesda, MD
20892, (301) 404-7419, rosenzweign@csr.nih.gov.
Name of Committee: Musculoskeletal, Oral and Skin Sciences
Integrated Review Group; Oral, Dental and Craniofacial Sciences
Study Section.
Date: June 11, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites Washington DC, Convention Center, 900 10th
Street NW., Washington, DC 20001.
Contact Person: Yi-Hsin Liu, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 4214, MSC 7814, Bethesda, MD 20892, 301-435-
1781, liuyh@csr.nih.gov
Name of Committee: Integrative, Functional and Cognitive
Neuroscience Integrated Review Group; Neurobiology of Learning and
Memory Study Section.
Date: June 11, 2014.
Time: 8:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suites at the Chevy Chase Pavilion, 4300 Military
Road, NW, Washington, DC 20015.
Contact Person: Wei-Qin Zhao, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive Room 5181 MSC 7846, Bethesda, MD 20892-7846, 301-
435-1236, zhaow@csr.nih.gov.
Name of Committee: Healthcare Delivery and Methodologies
Integrated Review Group; Dissemination and Implementation Research
in Health Study Section.
Date: June 11-12, 2014.
Time: 8:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Woodland Hills/Los Angeles, 6360 Canoga Avenue,
Woodland Hills, CA 91367.
Contact Person: Martha L Hare, Ph.D., Scientific Review Officer,
Center for Scientific Review, National Institutes of Health, 6701
Rockledge Drive, Room 3154, Bethesda, MD 20892, (301) 451-8504,
harem@mail.nih.gov.
Name of Committee: Endocrinology, Metabolism, Nutrition and
Reproductive Sciences Integrated Review Group; Cellular Aspects of
Diabetes and Obesity Study Section.
Date: June 11-12, 2014.
Time: 8:00 a.m. to 3:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hotel Nikko San Francisco, 222 Mason Street, San
Francisco, CA 94102.
Contact Person: Robert Garofalo, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institute of Health,
6701 Rockledge Drive, Room 6156, MSC 7892, Bethesda, MD, 20892, 301-
435-1043, garofalors@csr.nih.gov.
Name of Committee: Oncology 1-Basic Translational Integrated
Review Group; Cancer Genetics Study Section.
Date: June 11, 2014.
Time: 8:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant applications.
Place: St. Gregory Hotel, 2033 M Street, NW, Washington, DC
20036.
Contact Person: Michael L Bloom, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6187, MSC 7804, Bethesda, MD
20892, 301-451-0132, bloomm2@mail.nih.gov.
Name of Committee: Brain Disorders and Clinical Neuroscience
Integrated Review Group; Neural Basis of Psychopathology, Addictions
and Sleep Disorders Study Section.
Date: June 11, 2014.
Time: 8:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda,
MD 20814.
Contact Person: Boris P. Sokolov, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5217A, MSC 7846, Bethesda, MD
20892, 301-408-9115, bsokolov@csr.nih.gov.
Name of Committee: Brain Disorders and Clinical Neuroscience
Integrated Review Group; Acute Neural Injury and Epilepsy Study
Section.
Date: June 11, 2014.
Time: 8:00 a.m. to 6:30 p.m.
Agenda: To review and evaluate grant applications.
Place: Embassy Suite DC Convention Center, 900 10th Street NW.,
Washington, DC 20001.
Contact Person: Seetha Bhagavan, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5194, MSC 7846, Bethesda, MD
20892, (301) 237-9838, bhagavas@csr.nih.gov.
Name of Committee: Population Sciences and Epidemiology
Integrated Review Group; Kidney, Nutrition, Obesity and Diabetes
Study Section.
Date: June 11-12, 2014.
Time: 8:30 a.m. to 12:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Sir Francis Drake Hotel, 450 Powell Street at Sutter, San
Francisco, CA 94102.
Contact Person: Fungai Chanetsa, Ph.D., MPH, Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3135, MSC 7770, Bethesda, MD
20892, 301-408-9436, fungai.chanetsa@nih.hhs.gov.
Name of Committee: Population Sciences and Epidemiology
Integrated Review Group; Societal and Ethical Issues in Research
Study Section.
Date: June 11, 2014.
Time: 9:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant applications.
Place: Hilton Garden Inn Bethesda, 7301 Waverly Street,
Bethesda, MD 20814.
Contact Person: Karin F. Helmers, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3144, MSC 7770, Bethesda, MD
20892, (301) 254-9975, helmersk@csr.nih.gov.
(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: May 12, 2014.
Anna Snouffer,
Deputy Director, Office of Federal Advisory Committee Policy.
[FR Doc. 2014-11246 Filed 5-15-14; 8:45 am]
BILLING CODE 4140-01-P
