National Institutes of Health, 53685-53686 [2011-21980]
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53685
Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Draft guidance on monitoring clinical investigations
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Development of Comprehensive Monitoring Plan ...............
Voluntary Submission of Monitoring Plans to FDA .............
88
22
1.5
1.5
132
33
4
2
528
66
Total ..............................................................................
N/A
N/A
N/A
6
594
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
III. Comments
personnel: (1) To assess the quality of
the modified operations and processes
now used by CSR to review grant
applications; (2) To assess the quality of
service provided by CSR to our
customers; (3) To enable identification
of the most promising biomedical
research that will have the greatest
impact on improving public health by
using a peer review process that is fair
unbiased from outside influence, timely,
and (4) To develop new modes of
operation based on customer need and
customer feedback about the efficacy of
implemented modifications. These
surveys will almost certainly lead to
quality improvement activities to
enhance and/or streamline CSR’s
operations. The major mechanism by
which CSR will request input is through
surveys. The major initiatives ongoing at
the present time include: Shortening the
review and application process,
shortening the grant application,
recruiting the best reviewers by
developing additional review modes,
improving study section alignment to
ensure the best reviews, and others.
Surveys will be collected via Internet.
Information gathered from these surveys
will be presented to, and used directly
by, CSR management to enhance the
operations, processes, organization of,
and services provided by the Center.
Frequency of Response: The
participants will respond once, unless
there is a compelling reason for a
subsequent survey. Affected public:
Universities, not-forprofit institutions,
business or other forprofit, small
businesses and organizations, and
individuals. Type of Respondents: Adult
scientific professionals.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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.
National Institutes of Health
Submission for OMB Review;
Comment Request; Partner and
Customer Satisfaction Surveys
Under the provisions of
Section 3507(a)(l)(D) of the Paperwork
Reduction Act of 1995 for the
opportunity for public comment on the
proposed data collection projects, the
Center for Scientific Review (CSR),
National Institutes of Health (NIH), has
submitted to the Office of Management
and Budget (OMB) a request to review
and approve the information collection
listed below. This proposed information
collection was previously published in
the Federal Register on July 22, 2011
(Vol. 76, No. 141, p. 44020) and allowed
60-days for public comment. There was
one public comment received during
this time.
The purpose of this notice is to allow
30 days for public comment. The
National Institutes of Health may not
conduct or sponsor and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
Proposed Collection: Title: Extension
of Generic Clearance for Voluntary
Partner and Customer Satisfaction
Surveys.
Type of Information Collection
Request: Extension.
Need and Use of Information
Collection: The information collected in
these surveys will be used by the Center
for Scientific Review management and
SUMMARY:
IV. Electronic Access
Persons with access to the Internet
may obtain the document at either
https://www.fda.gov/Drugs/
GuidanceCompliance
RegulatoryInformation/Guidances/
default.htm, https://www.fda.gov/
BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/default.htm, https://www.
fda.gov/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/default.htm, or
https://www.regulations.gov.
Dated: August 23, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011–21972 Filed 8–26–11; 8:45 am]
BILLING CODE 4160–01–P
ESTIMATES OF ANNUALIZED HOUR BURDEN
Emcdonald on DSK2BSOYB1PROD with NOTICES
[Totals rounded off to the nearest hour]
Number of
respondents
Type of respondent
Frequency of
response
Average time
per response
(Hr)
Total annual
hour burden
Adult scientific professionals (via Mail/Telephone/Internet) ............................
Adult scientific professional (via focus groups) ...............................................
5000
75
1
1
0.25
1
1250
188
Total ..........................................................................................................
5075
........................
........................
1438
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53686
Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Notices
Requests for Comments: Written
comments and/or suggestions from the
public and affected agencies are invited
on one or more of the following points:
(1) Whether the proposed collection of
information is necessary for the proper
performance of the functions of the CSR,
including whether the information will
have practical utility; (2) The accuracy
of the agency’s estimate of the burden of
the proposed collection of information,
including the validity of the
methodology and assumptions used;
(3) Ways to enhance the quality, utility,
and clarity of the information to be
collected; and (4) Ways to minimize the
burden of the collection of information
on those who are to respond while
maintaining their anonymity, including
the use of automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Direct Comments to OMB: Written
comments and/or suggestions regarding
the item(s) contained in this notice,
especially regarding the estimated
public burden and associated response
time, should be directed to the: Office
of Management and Budget, Office of
Regulatory Affairs,
OIRA_submission@omb.eop.gov, or by
fax to 202–395–6974, Attention: Desk
Officer for NIH. To request more
information on the proposed project or
to obtain a copy of the data collection
plans and instruments, contact George
Chacko, PhD, Center for Scientific
Review, NIH, Room 3030, 6701
Rockledge Drive, Bethesda, MD 20892–
7776, or call non-toll-free number 301–
435–1133 or E-mail your request,
including your address to:
chackoge@csr.nih.gov.
Comments Due Date: Comments
regarding this information collection are
best assured of having their full effect if
received within 30-days of the date of
publication of this notice.
Dated: August 22, 2011.
George Chacko,
Director of Planning, Analysis, and
Evaluation, CSR, National Institutes of
Health.
[FR Doc. 2011–21980 Filed 8–26–11; 8:45 am]
BILLING CODE 4140–01–P
amended (5 U.S.C. App.), notice is
hereby given of a meeting of the
National Advisory Child Health and
Human Development Council.
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 intramural programs
and projects and discussions could
disclose confidential trade secrets or
commercial property such as patentable
material, and personal information
concerning individuals associated with
the intramural programs and projects,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Advisory
Child Health and Human Development
Council; NACHHD Subcommittee on
Planning and Policy.
Date: September 6, 2011.
Closed: 9 a.m. to 10:30 a.m.
Agenda: To review and evaluate the
Division of Intramural Research Laboratories
site visit reports.
Place: National Institutes of Health,
Building 31, 31 Center Drive, Room 31 2A03,
Bethesda, MD 20892 (Telephone Conference
Call).
Information is also available on the
Institute’s/Center’s home page: https://
www.nichd.nih.gov/about/nachhd.htm,
where an agenda and any additional
information for the meeting will be posted
when available.
This notice is being published less than 15
days prior to the meeting due to the urgent
need to meet timing limitations imposed by
the intramural research review cycle.
(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: August 22, 2011.
Jennifer S. Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2011–21967 Filed 8–26–11; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Emcdonald on DSK2BSOYB1PROD with NOTICES
National Institutes of Health
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Eunice Kennedy Shriver National
Institute of Child Health & Human
Development; Notice of Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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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
PO 00000
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Sfmt 4703
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: Integrative,
Functional and Cognitive Neuroscience
Integrated Review Group, Somatosensory and
Chemosensory Systems Study Section.
Date: October 4–5, 2011.
Time: 8 a.m. to 4 p.m.
Agenda: To review and evaluate grant
applications.
Place: Westin Alexandria, 400 Courthouse
Square, Alexandria, VA 22314.
Contact Person: M Catherine Bennett, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 5182,
MSC 7846, Bethesda, MD 20892, 301–435–
1766, bennettc3@csr.nih.gov.
Name of Committee: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group, Cellular,
Molecular and Integrative Reproduction
Study Section.
Date: October 4, 2011.
Time: 8 a.m. to 5 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: Gary Hunnicutt, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6164,
MSC 7892, Bethesda, MD 20892, 301–435–
0229, gary.hunnicutt@nih.gov.
Name of Committee: Musculoskeletal, Oral
and Skin Sciences Integrated Review Group,
Oral, Dental and Craniofacial Sciences Study
Section.
Date: October 4–5, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Beacon Hotel and Corporate
Quarters, 1615 Rhode Island Avenue, NW.,
Washington, DC 20036.
Contact Person: Yi-Hsin Liu, PhD,
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: Endocrinology,
Metabolism, Nutrition and Reproductive
Sciences Integrated Review Group,
Pregnancy and Neonatology Study Section.
Date: October 4, 2011.
Time: 8 a.m. to 5 p.m.
Agenda: To review and evaluate grant
applications.
Place: Hyatt Regency—Baltimore, 300
Light Street, Baltimore, MD 21202.
Contact Person: Michael Knecht, PhD,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
E:\FR\FM\29AUN1.SGM
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]]>Agencies
[Federal Register Volume 76, Number 167 (Monday, August 29, 2011)]
[Notices]
[Pages 53685-53686]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21980]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; Comment Request; Partner and Customer
Satisfaction Surveys
SUMMARY: Under the provisions of Section 3507(a)(l)(D) of the Paperwork
Reduction Act of 1995 for the opportunity for public comment on the
proposed data collection projects, the Center for Scientific Review
(CSR), National Institutes of Health (NIH), has submitted to the Office
of Management and Budget (OMB) a request to review and approve the
information collection listed below. This proposed information
collection was previously published in the Federal Register on July 22,
2011 (Vol. 76, No. 141, p. 44020) and allowed 60-days for public
comment. There was one public comment received during this time.
The purpose of this notice is to allow 30 days for public comment.
The National Institutes of Health may not conduct or sponsor and the
respondent is not required to respond to, an information collection
that has been extended, revised, or implemented on or after October 1,
1995, unless it displays a currently valid OMB control number.
Proposed Collection: Title: Extension of Generic Clearance for
Voluntary Partner and Customer Satisfaction Surveys.
Type of Information Collection Request: Extension.
Need and Use of Information Collection: The information collected
in these surveys will be used by the Center for Scientific Review
management and personnel: (1) To assess the quality of the modified
operations and processes now used by CSR to review grant applications;
(2) To assess the quality of service provided by CSR to our customers;
(3) To enable identification of the most promising biomedical research
that will have the greatest impact on improving public health by using
a peer review process that is fair unbiased from outside influence,
timely, and (4) To develop new modes of operation based on customer
need and customer feedback about the efficacy of implemented
modifications. These surveys will almost certainly lead to quality
improvement activities to enhance and/or streamline CSR's operations.
The major mechanism by which CSR will request input is through surveys.
The major initiatives ongoing at the present time include: Shortening
the review and application process, shortening the grant application,
recruiting the best reviewers by developing additional review modes,
improving study section alignment to ensure the best reviews, and
others. Surveys will be collected via Internet. Information gathered
from these surveys will be presented to, and used directly by, CSR
management to enhance the operations, processes, organization of, and
services provided by the Center.
Frequency of Response: The participants will respond once, unless
there is a compelling reason for a subsequent survey. Affected public:
Universities, not-forprofit institutions, business or other forprofit,
small businesses and organizations, and individuals. Type of
Respondents: Adult scientific professionals.
Estimates of Annualized Hour Burden
[Totals rounded off to the nearest hour]
----------------------------------------------------------------------------------------------------------------
Average time
Type of respondent Number of Frequency of per response Total annual
respondents response (Hr) hour burden
----------------------------------------------------------------------------------------------------------------
Adult scientific professionals (via Mail/ 5000 1 0.25 1250
Telephone/Internet)............................
Adult scientific professional (via focus groups) 75 1 1 188
---------------------------------------------------------------
Total....................................... 5075 .............. .............. 1438
----------------------------------------------------------------------------------------------------------------
[[Page 53686]]
Requests for Comments: Written comments and/or suggestions from the
public and affected agencies are invited on one or more of the
following points: (1) Whether the proposed collection of information is
necessary for the proper performance of the functions of the CSR,
including whether the information will have practical utility; (2) The
accuracy of the agency's estimate of the burden of the proposed
collection of information, including the validity of the methodology
and assumptions used; (3) Ways to enhance the quality, utility, and
clarity of the information to be collected; and (4) Ways to minimize
the burden of the collection of information on those who are to respond
while maintaining their anonymity, including the use of automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Direct Comments to OMB: Written comments and/or suggestions
regarding the item(s) contained in this notice, especially regarding
the estimated public burden and associated response time, should be
directed to the: Office of Management and Budget, Office of Regulatory
Affairs, OIRA_submission@omb.eop.gov, or by fax to 202-395-6974,
Attention: Desk Officer for NIH. To request more information on the
proposed project or to obtain a copy of the data collection plans and
instruments, contact George Chacko, PhD, Center for Scientific Review,
NIH, Room 3030, 6701 Rockledge Drive, Bethesda, MD 20892-7776, or call
non-toll-free number 301-435-1133 or E-mail your request, including
your address to: chackoge@csr.nih.gov.
Comments Due Date: Comments regarding this information collection
are best assured of having their full effect if received within 30-days
of the date of publication of this notice.
Dated: August 22, 2011.
George Chacko,
Director of Planning, Analysis, and Evaluation, CSR, National
Institutes of Health.
[FR Doc. 2011-21980 Filed 8-26-11; 8:45 am]
BILLING CODE 4140-01-P
