Submission for OMB Review; Comment Request, 447-448 [E8-31306]
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Federal Register / Vol. 74, No. 3 / Tuesday, January 6, 2009 / Notices
3. The acquisition is not a commercial
item acquisition.
4. The acquisition offers more than
minimal subcontracting opportunities.
B. Annual Reporting Burden
Respondents: 1,020.
Responses per Respondent: 1.
Hours Per Response: 12.
Total Burden Hours: 12,240.
Obtaining Copies of Proposals:
Requesters may obtain a copy of the
information collection documents from
the General Services Administration,
Regulatory Secretariat (VPR), 1800 F
Street, NW., Room 4041, Washington,
DC 20405, telephone (202) 501–4755.
Please cite OMB Control No. 3090–0252,
Preparation, Submission, and
Negotiation of Subcontracting Plans, in
all correspondence.
Dated: December 2, 2008.
Al Matera, Director, Office of Acquisition
Policy.
[FR Doc. E8–31456 Filed 1–5–09; 8:45 am]
BILLING CODE 6820–61–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Announcement of the Release of the
U.S. Department of Health and Human
Services’ Action Plan To Prevent
Healthcare-Associated Infections
AGENCY: Department of Health and
Human Services, Office of the Secretary,
Office of Public Health and Science.
ACTION: Notice.
Authority: 42 U.S.C 200u.
The Office of Public Health
and Science (OPHS), U.S. Department of
Health and Human Services (HHS),
announces the release of the HHS
Action Plan To Prevent HealthcareAssociated Infections (HHS Action
Plan). The effort represents a
culmination of several months of
deliberation by subject matter experts
across HHS to identify key actions in
the prevention of healthcare-associated
infections (HAIs). The document
establishes national goals for enhancing
and coordinating HHS-supported
efforts, including the development of (1)
National benchmarks; (2) prioritized
recommended clinical practices to
facilitate implementation of and
adherence to existing recommended
practices in hospitals; (3) a coordinated
research agenda to strengthen the
science for infection control prevention
in hospitals; (4) a plan to progress
towards the standardized measures and
data definitional alignment needed to
more accurately measure HAIs and
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SUMMARY:
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make the varied HHS data systems
interoperable; (5) opportunities for
evaluating compliance with infection
control practices in hospitals through
certification processes and potential
options for the use of payment policies
and financial incentives to motivate
organizations to provide better, more
efficient care; and (6) a national
messaging plan to build partnerships
with various stakeholder groups across
the country.
Background: Healthcare-associated
infections exact a significant toll on
human life. They are among the top ten
leading causes of death in the United
States, accounting for an estimated 1.7
million infections and 99,000 associated
deaths. In hospitals, they are a
significant cause of morbidity and
mortality. In addition to the substantial
human suffering exacted by HAIs, the
financial burden attributable to these
infections is staggering. It is estimated
that HAIs incur nearly $20 billion in
excess healthcare costs each year. For
these reasons, the reduction of HAIs is
a top priority for HHS.
The HHS Steering Committee to
Prevent Healthcare-Associated
Infections (Committee) was established
in July 2008. The Committee was
charged with developing a strategy to
reduce HAIs and issuing a plan which
establishes national goals for HAI
prevention and outlines key actions for
achieving identified short- and longterm objectives. The plan is also
intended to enhance collaboration with
external stakeholders to maximize
coordination and impact of national
efforts. Thus, the development process
of the HHS Action Plan is inclusive. The
goal is to effectively collaborate with
multiple stakeholders to maximize
reach and impact in order to effectively
prevent HAIs. The process strives to
maximize transparency, public input,
and stakeholder dialogue to ensure that
the HHS Action Plan is relevant to
multiple audiences and diverse public
health needs and seizes opportunities to
achieve its goals. Drawing on the
expertise of the HHS Steering
Committee To Prevent HealthcareAssociated Infections, other experts
across the Federal Government, various
stakeholders, and the public, the HHS
Action Plan will establish a national
strategy for the reduction and
prevention of HAIs. The public is
invited to comment through the Web
site on the content of the document. The
plan is intended to be updated
periodically in response to public input
and new recommendations for infection
prevention.
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447
ADDRESSES: The Action Plan To Prevent
Healthcare-Associated Infections and
instructions for submitting comments
can be viewed at https://www.hhs.gov/
ophs.
FOR FURTHER INFORMATION CONTACT:
Send questions to the Office of Public
Health and Science, U.S. Department of
Health and Human Services, Ms. Julie
Moreno at Julie.Moreno@hhs.gov
(e-mail), (202) 401–9581 (phone), or
(202) 690–6960 (fax) or Ms. Rani Jeeva
at Rani.Jeeva@hhs.gov (e-mail), (240)
276–9824 (phone), or (240) 276–9860
(fax).
Dated: December 22, 2008.
Donald Wright,
Principal Deputy Assistant Secretary for
Health.
[FR Doc. E8–31195 Filed 1–5–09; 10:58 am]
BILLING CODE 4150–28–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Proposed Project:
Title: Feasibility Test for Design Phase
of National Study of Child Care Supply
and Demand.
OMB No.: New Collection.
Description: The 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 to collect information as
part of the Design Phase of the National
Study of Child Care Supply and
Demand. This effort will gather
information that will be useful for
evaluating the feasibility and improving
the design of a national study of child
care supply and demand.
The proposed collection will consist
of: A random-digit dial survey of
households with children under age 13
for participation in a questionnaire
about the demand for child care; a
random-digit dial survey of households
with individuals providing care to
children under age 13 in a residential
setting; a telephone screening of afterschool programs for eligibility in a
survey of child care providers; a
telephone survey of providers of care to
children under age 13; an in-person
survey of providers of care to children
under age 13; and, an in-person survey
of parents of children under age 13 who
are in non-parental care arrangements.
These data collection efforts will be
used to examine the functioning of draft
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448
Federal Register / Vol. 74, No. 3 / Tuesday, January 6, 2009 / Notices
survey instruments. The feasibility test
procedures will help inform several
decisions about proposed design of the
national study including sampling
methods, costs and advantages
associated with alternative interviewing
protocols and reactions to the proposed
methods.
Respondents: General population
households, home-based and centerbased child care providers, and public
schools serving children under age 13.
ANNUAL BURDEN ESTIMATES
Annual
number of
respondents
Instrument
Eligibility calls to Before/After School Programs .........................................
Household screening calls ...........................................................................
Telephone calls with households with children under age ..........................
Telephone calls with providers of home-based care ...................................
Telephone calls with center-based providers of before/after school care ..
In-person interviews with parents of children in non-parental care ............
In-person interviews with child-care provider staff ......................................
Estimated Total Annual Burden
Hours: 365.2.
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: December 29, 2008.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. E8–31306 Filed 1–5–09; 8:45 am]
BILLING CODE 4184–01–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
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National Institutes of Health
Submission for OMB Review;
Comment Request Information
Program on Clinical Trials: Maintaining
a Registry and Results Databank
SUMMARY: Under the provisions of
Section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Library of Medicine (NLM), the National
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Number of
responses per
respondent
Average burden
hours per
response
1
1
1
1
1
1
1
.2
15
5
.3
.5
.4
4
150
1000
160
104
68
50
50
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 October 8, 2008 (Vol. 73,
No. 196, p. 58973) and allowed 60 days
for public comment. One public
comment was received. The purpose of
this notice is to allow an additional 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:
Information Program on Clinical Trials:
Maintaining a Registry and Results
Databank; Type of Information
Collection Request: Revision of
currently approved collection [OMB No.
0925–0586, expiration date 01/31/2009],
Form Number: N/A; Need and Use of
Information Collection: The National
Institutes of Health is modifying the
clinical trial registry databank
established under previous law
[FDAMA, Section 113] to comply with
provisions of Title VIII of Public Law
110–85 (Food and Drug Administration
Amendments Act of 2007). The
databank collects specified registration
and results information on certain
clinical trials identified in the law, with
the objective of enhancing patient
enrollment and providing a mechanism
for tracking subsequent progress of
clinical trials, to the benefit of public
health. The databank is widely used by
patients, physicians, and medical
researchers; in particular, those
involved in clinical research studies.
Public Law 110–85 expands the scope of
clinical trials that must be registered in
ClinicalTrials.gov, increases the clinical
trial information that must be submitted
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Estimated
annual burden
hours
30
150
80
31.2
34
20
20
as part of each registration, and requires
the submission of basic results
information for registered trials of
approved drugs, biologics and devices.
Frequency of Response: Responsible
parties must submit the required
registration information not later than
21 days after enrolling the first subject.
Results information is to be reported not
later than 12 months after the
completion date (as defined in the law),
but the responsible party may request an
extension of the deadline or delay
submission by certifying that the drug or
device under study has not yet been
approved. Updates to submitted
information are required at least once a
year, unless there are no changes to
report. Changes in recruitment status
and completion of a trial must be
reported not later than 30 days after
such events. Description of
Respondents: Respondents are referred
to in the law as ‘‘responsible parties,’’
and are defined as: (1) The sponsor of
the clinical trial (as defined in 21 CFR
50.3) or (2) the principal investigator of
such clinical trial if so designated by a
sponsor, grantee, contractor, or awardee,
provided that ‘‘the principal investigator
is responsible for conducting the trial,
has access to and control over the data
from the clinical trial, has the right to
publish the results of the trial, and has
the ability to meet all of the
requirements’’ for submitting
information under the law. Estimate of
Burden: The burden associated with this
information collection consists of two
parts: the burden associated with
registration of clinical trials; and the
burden associated with the reporting of
results information. In both cases, the
burden includes the time necessary to
extract information from the study
protocol or results record, reformat and
review it, enter it into the databank, and
provide necessary updating over the
course of the study. It is estimated that
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]]>Agencies
[Federal Register Volume 74, Number 3 (Tuesday, January 6, 2009)]
[Notices]
[Pages 447-448]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-31306]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Proposed Project:
Title: Feasibility Test for Design Phase of National Study of Child
Care Supply and Demand.
OMB No.: New Collection.
Description: The 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 to collect
information as part of the Design Phase of the National Study of Child
Care Supply and Demand. This effort will gather information that will
be useful for evaluating the feasibility and improving the design of a
national study of child care supply and demand.
The proposed collection will consist of: A random-digit dial survey
of households with children under age 13 for participation in a
questionnaire about the demand for child care; a random-digit dial
survey of households with individuals providing care to children under
age 13 in a residential setting; a telephone screening of after-school
programs for eligibility in a survey of child care providers; a
telephone survey of providers of care to children under age 13; an in-
person survey of providers of care to children under age 13; and, an
in-person survey of parents of children under age 13 who are in non-
parental care arrangements.
These data collection efforts will be used to examine the
functioning of draft
[[Page 448]]
survey instruments. The feasibility test procedures will help inform
several decisions about proposed design of the national study including
sampling methods, costs and advantages associated with alternative
interviewing protocols and reactions to the proposed methods.
Respondents: General population households, home-based and center-
based child care providers, and public schools serving children under
age 13.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden Estimated
Instrument Annual number responses per hours per annual burden
of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Eligibility calls to Before/After School 150 1 .2 30
Programs.....................................
Household screening calls..................... 1000 1 15 150
Telephone calls with households with children 160 1 5 80
under age....................................
Telephone calls with providers of home-based 104 1 .3 31.2
care.........................................
Telephone calls with center-based providers of 68 1 .5 34
before/after school care.....................
In-person interviews with parents of children 50 1 .4 20
in non-parental care.........................
In-person interviews with child-care provider 50 1 4 20
staff........................................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 365.2.
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: December 29, 2008.
Steven M. Hanmer,
OPRE Reports Clearance Officer.
[FR Doc. E8-31306 Filed 1-5-09; 8:45 am]
BILLING CODE 4184-01-M
