Submission for OMB Review; Comment Request, 53682-53683 [2011-21863]
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Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Notices
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[FR Doc. 2011–21986 Filed 8–26–11; 8:45 am]
BILLING CODE 6712–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Formative Data Collections for
Informing Policy Research.
OMB No.: 0970–0356.
Description: The Office of Planning,
Research and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS),
intends to request approval from the
Office of Management and Budget
(OMB) for a generic clearance that will
allow OPRE to conduct a variety of
qualitative data collections. Over the
next three years, OPRE anticipates
undertaking a variety of new research
projects in the fields of cash welfare,
employment and self-sufficiency, Head
Start, child care, healthy marriage and
responsible fatherhood, and child
welfare. In order to inform the
development of OPRE research, to
maintain a research agenda that is
rigorous and relevant, and to ensure that
research products are as current as
possible, OPRE will engage in a variety
of qualitative data collections in concert
with researchers and practitioners
throughout the field. OPRE envisions
using a variety of techniques including
semi-structured discussions, focus
groups, telephone interviews, and inperson observations and site visits, in
order to integrate the perspectives of
program operators, policy officials and
members of the research community.
Following standard Office of
Management and Budget (OMB)
requirements, OPRE will submit a
change request to OMB individually for
every group of data collection activities
undertaken under this generic
clearance. OPRE will provide OMB with
a copy of the individual instruments or
questionnaires (if one is used), as well
as other materials describing the project.
Respondents: Administrators or staff
of State and local agencies or programs
in the relevant fields; academic
researchers; and policymakers at various
levels of government.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Emcdonald on DSK2BSOYB1PROD with NOTICES
Semi-Structured Discussion and Information-Gathering Protocol ...................
Estimated Total Annual Burden
Hours: 1200.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. E-mail address:
OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
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16:45 Aug 26, 2011
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Dated: August 22, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011–21868 Filed 8–26–11; 8:45 am]
BILLING CODE 4184–22–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Pre-testing of Evaluation
Surveys.
OMB No.: 0970–0355.
Description: The Office of Planning,
Research and Evaluation (OPRE),
Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS),
intends to request approval from the
Office of Management and Budget
(OMB) for a generic clearance that a will
allow OPRE to conduct a variety of data
gathering activities aimed at identifying
questionnaire and procedural problems
PO 00000
Frm 00020
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
Average
burden hours
per response
.5
Total annual
burden hours
1200
in survey administration. Over the next
three years, OPRE anticipates
undertaking a variety of new surveys as
part of research projects in the fields of
cash welfare, employment and selfsufficiency, Head Start, child care,
healthy marriage and responsible
fatherhood, and child welfare, among
others. In order to improve the
development of its research and
evaluation surveys, OPRE envisions
using a variety of techniques including
field tests, respondent debriefing
questionnaires, cognitive interviews and
focus groups in order to identify
questionnaire and procedural problems,
suggest solutions, and measure the
relative effectiveness of alternative
survey solutions.
Following standard OMB
requirements, OPRE will submit a
change request to OMB individually for
every data collection activity
undertaken under this generic
clearance. OPRE will provide OMB with
a copy of the individual instrument or
questionnaire, as well as other materials
describing the project and specific
survey pretest.
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Federal Register / Vol. 76, No. 167 / Monday, August 29, 2011 / Notices
Respondents: The respondents will be
identified at the time that each change
request is submitted to OMB. Generally
they will be individuals who are
representative of the target groups for
the public assistance research or
evaluation project in question.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Survey development field tests, respondent debriefing questionnaires, cognitive interviews and focus groups ...............................................................
Estimated Total Annual Burden
Hours: 3000.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 370
L’Enfant Promenade, SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. E-mail address:
OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication.
Written comments and
recommendations for the proposed
information collection should be sent
directly to the following: Office of
Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Dated: August 22, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011–21863 Filed 8–26–11; 8:45 am]
BILLING CODE 4184–07–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Emcdonald on DSK2BSOYB1PROD with NOTICES
[Docket No. FDA–2011–D–0597]
Draft Guidance for Industry on
Oversight of Clinical Investigations: A
Risk-Based Approach to Monitoring;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
SUMMARY:
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industry entitled ‘‘Oversight of Clinical
Investigations: A Risk-Based Approach
to Monitoring.’’ This guidance is
intended to assist sponsors in
developing risk-based monitoring
strategies and plans for clinical
investigations of human drugs,
biologics, medical devices, and
combinations thereof. The overarching
goal of this guidance is to enhance
human subject protection and the
quality of clinical trial data. The
guidance is intended to make clear that
sponsors can use a variety of approaches
to meet their monitoring responsibilities
when conducting investigational new
drug (IND) or investigational device
exemption (IDE) studies.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by November 28,
2011.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201,
Silver Spring, MD 20993–0002; the
Office of Communication, Outreach and
Development (HFM–40), Center for
Biologics Evaluation and Research,
Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville,
MD 20852–1448; or the Office of
Communication, Education and
Radiation Programs, Division of Small
Manufacturers, International and
Consumer Assistance, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613,
Silver Spring, MD 20993–0002. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
Submit electronic comments on the
draft guidance to https://
PO 00000
Frm 00021
Fmt 4703
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Number of
responses per
respondent
1
Average
burden hours
per response
.5
Total annual
burden hours
3000
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.
FOR FURTHER INFORMATION CONTACT: Ann
Meeker-O’Connell, Center for Drug
Evaluation and Research (HFD–45),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm.
5339, Silver Spring, MD 20993–0002,
301–796–3150; or Stephen Ripley,
Center for Biologics Evaluation and
Research (HFM–17), Food and Drug
Administration, 1401 Rockville Pike,
suite 200N, Rockville, MD 20852–1448,
301–827–6210; or Chrissy Cochran,
Center for Devices and Radiological
Health (HFZ–311), Food and Drug
Administration, 10993 New Hampshire
Ave., Bldg. 66, rm. 3453, Silver Spring,
MD 20993–0002, 301–796–5490.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Oversight of Clinical Investigations: A
Risk-Based Approach to Monitoring.’’
FDA is publishing this new draft
guidance to assist sponsors of clinical
investigations in developing risk-based
monitoring strategies and plans for
clinical investigations of human drug
and biological products, medical
devices, and combinations thereof. This
guidance is intended to make clear that
sponsors can use a variety of approaches
to meet their monitoring responsibilities
during clinical investigations. This
guidance describes a modern, risk-based
approach to monitoring that focuses on
critical study parameters and relies on
a combination of monitoring activities
to effectively oversee a study. For
example, the guidance encourages
greater use of centralized monitoring
methods where appropriate. The
guidance also makes recommendations
about how to develop monitoring plans
and document monitoring activities.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
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]]>Agencies
[Federal Register Volume 76, Number 167 (Monday, August 29, 2011)]
[Notices]
[Pages 53682-53683]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-21863]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Pre-testing of Evaluation Surveys.
OMB No.: 0970-0355.
Description: The Office of Planning, Research and Evaluation
(OPRE), Administration for Children and Families (ACF), U.S. Department
of Health and Human Services (HHS), intends to request approval from
the Office of Management and Budget (OMB) for a generic clearance that
a will allow OPRE to conduct a variety of data gathering activities
aimed at identifying questionnaire and procedural problems in survey
administration. Over the next three years, OPRE anticipates undertaking
a variety of new surveys as part of research projects in the fields of
cash welfare, employment and self-sufficiency, Head Start, child care,
healthy marriage and responsible fatherhood, and child welfare, among
others. In order to improve the development of its research and
evaluation surveys, OPRE envisions using a variety of techniques
including field tests, respondent debriefing questionnaires, cognitive
interviews and focus groups in order to identify questionnaire and
procedural problems, suggest solutions, and measure the relative
effectiveness of alternative survey solutions.
Following standard OMB requirements, OPRE will submit a change
request to OMB individually for every data collection activity
undertaken under this generic clearance. OPRE will provide OMB with a
copy of the individual instrument or questionnaire, as well as other
materials describing the project and specific survey pretest.
[[Page 53683]]
Respondents: The respondents will be identified at the time that
each change request is submitted to OMB. Generally they will be
individuals who are representative of the target groups for the public
assistance research or evaluation project in question.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total annual
respondents respondent per response burden hours
----------------------------------------------------------------------------------------------------------------
Survey development field tests, respondent 6000 1 .5 3000
debriefing questionnaires, cognitive interviews
and focus groups...............................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 3000.
Additional Information: Copies of the proposed collection may be
obtained by writing to the Administration for Children and Families,
Office of Planning, Research and Evaluation, 370 L'Enfant Promenade,
SW., Washington, DC 20447, Attn: OPRE Reports Clearance Officer. All
requests should be identified by the title of the information
collection. E-mail address: OPREinfocollection@acf.hhs.gov.
OMB Comment: OMB is required to make a decision concerning the
collection of information between 30 and 60 days after publication of
this document in the Federal Register. Therefore, a comment is best
assured of having its full effect if OMB receives it within 30 days of
publication.
Written comments and recommendations for the proposed information
collection should be sent directly to the following: Office of
Management and Budget, Paperwork Reduction Project, Fax: 202-395-6974,
Attn: Desk Officer for the Administration for Children and Families.
Dated: August 22, 2011.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2011-21863 Filed 8-26-11; 8:45 am]
BILLING CODE 4184-07-M
