Proposed Information Collection Activity; Comment Request, 7478-7479 [2015-02698]
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Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices
effectiveness of messages for intended
audiences.
Data collection methods proposed for
HMTS includes intercept interviews,
telephone interviews, focus groups,
online surveys, and cognitive
interviews. In almost all instances, data
will be collected by outside
organizations under contract with CDC.
For many years CDC programs have
used HMTS to test and refine message
concepts and test draft materials for
clarity, salience, appeal, and
persuasiveness to target audiences.
Having this generic clearance available
has enabled them to test their
information and get critical health
information out to the public quickly.
Over the last three years, more than 20
messages have been tested using this
clearance. For example: Evaluation of
Emergency Preparedness Materials for
Limited English Proficient Spanish
Speakers. Risk communication is a top
priority in CDC’s anthrax preparedness
activities. The Anthrax Management
Team developed materials to provide
LEP Spanish-speakers with information
(NIOSH) conducted a field study,
Spanish Trench Safety CD–ROM, to
determine the most effective way to
disseminate trench safety information to
Latino immigrant workers using
computer-based training. Using results
of this study, NIOSH produced the CD–
ROM and are preparing to field test the
product. As part of this project, a
tutorial was also created for workers
with limited computer literacy teaching
them how to use the computer. The
tutorial has been field tested and the
English and Spanish versions will
become NIOSH numbered publications.
Over 12,000 respondents were
queried and over 5,500 burden hours
used during this time period. Because
the availability of this ICR has been so
critical to programs in disseminating
their materials and information to the
public in a timely manner, OADC is
requesting a three year extension of this
information collection.
There is no cost to the respondents
other than their time. The total
estimated annualized burden hours are
2,470.
needed to increase the chances for
survival in the event that bioterrorists
attacked the U.S. using anthrax. Once
refined, based on participant feedback,
these materials will be used in creating
additional public education materials to
be utilized during an anthrax
emergency. The lessons learned about
communication with vulnerable
populations have application to others
who are seeking to improve
communication during a domestic or
global public health emergency.
The Division of Diabetes Translation
obtained OMB approval through HMTS
for Testing of Brand Concepts, Messages
and Materials for CDC’s National
Diabetes Prevention Program (National
DPP). Materials testing was conducted
with multiple audiences, and provided
the detailed level of feedback needed to
make materials that resonate with each
audience. Findings have also been used
to inform the development and testing
of a new brand for the National DPP
which will be launched in 2015.
The National Institute for
Occupational Safety and Health
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
Public Health Professionals, Health Care Providers, State and Local Public Health Officials, Emergency Responders, General
Public.
Moderator’s Guides, Eligibility Screeners,
Interview Guides, Opinion Surveys, Consent Forms.
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
[FR Doc. 2015–02592 Filed 2–9–15; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
rljohnson on DSK3VPTVN1PROD with NOTICES
Proposed Projects
Title: Child Care Development Fund
(CCDF)—Reporting Improper
Payments—Instructions for States.
OMB No.: 0970–0323.
Description: Section 2 of the Improper
Payments Act of 2002 provides for
estimates and reports of improper
payments by Federal agencies. Subpart
K of 45 CFR, Part 98 will require States
to prepare and submit a report of errors
18, 525
Number of
responses per
respondent
1
Average
burden per
response
(in hours)
8/60
occurring in the administration of CCDF
grant funds once every three years.
The Office of Child Care (OCC) is
completing the third 3-year cycle of case
record reviews to meet the requirements
for reporting under IPIA. The current
forms and instructions expire
September 30, 2015. OCC is submitting
the information collection for renewal
clearance with minor changes.
Responders will now have additional
guidance and clarification in the
instructions and errors have been
corrected. New language incorporates
requirements from the 2014 Child Care
and Development Fund Block Grant Act
passed in November 2014.
Respondents: State grantees, the
District of Columbia, and Puerto Rico.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Sampling Decisions and Fieldwork Preparation Plan .....................................
Record Review Worksheet ..............................................................................
VerDate Sep<11>2014
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Number of
responses per
respondent
17
17
E:\FR\FM\10FEN1.SGM
1
276
10FEN1
Average
burden hours
per response
106
6.33
Total burden
hours
1802
29,700.36
7479
Federal Register / Vol. 80, No. 27 / Tuesday, February 10, 2015 / Notices
ANNUAL BURDEN ESTIMATES—Continued
Number of
respondents
Instrument
State Improper Authorizations for Payment Report ........................................
Corrective Action Plan .....................................................................................
Estimated Total Annual Burden
Hours: 43,613.36.
In compliance with the requirements
of Section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: ACF Reports Clearance Officer.
Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
comments on: (a) Whether the proposed
collection of information is necessary
for the proper performance of the
functions of the agency, including
whether the information shall have
practical utility; (b) the accuracy of the
agency’s estimate of the burden of the
proposed collection of information; (c)
the quality, utility, and clarity of the
information to be collected; and (d)
ways to minimize the burden
information to be collected; and (d)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015–02698 Filed 2–9–15; 8:45 am]
rljohnson on DSK3VPTVN1PROD with NOTICES
BILLING CODE 4184–01–P
VerDate Sep<11>2014
15:20 Feb 09, 2015
Jkt 235001
Number of
responses per
respondent
17
8
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Average
burden hours
per response
1
1
639
156
Total burden
hours
10,863
1248
Hampshire Ave., Bldg. 22, Rm. 6244,
Silver Spring, MD 20993–0002, 301–
796–1300.
SUPPLEMENTARY INFORMATION:
[Docket No. FDA–2012–D–0973]
I. Background
Complicated Intra-Abdominal
Infections: Developing Drugs for
Treatment; Guidance for Industry;
Availability
FDA is announcing the availability of
a guidance for industry entitled
‘‘Complicated Intra-Abdominal
Infections: Developing Drugs for
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
development of drugs for the treatment
of cIAIs.
Intra-abdominal infections including
cIAIs are common in clinical practice
and comprise a wide variety of clinical
presentations and differing sources of
infection. Different bacterial pathogens
are responsible for cIAI, including
Gram-negative aerobic bacteria, Grampositive bacteria, and anaerobic
bacteria, including mixed infections.
This guidance describes the efficacy
endpoint of clinical success as
resolution of the baseline signs and
symptoms attributable to cIAI. The
guidance provides a scientific
justification for a noninferiority margin.
This guidance finalizes the draft
guidance of the same name issued
October 1, 2012. After consideration of
comments received in response to the
draft guidance, FDA updated the
guidance to include clarifications about
the primary efficacy endpoint and the
use of prior nontrial antibacterial drugs.
In addition, issuance of this guidance
fulfills a portion of the requirements of
Title VIII, section 804 of the Food and
Drug Safety and Innovation Act of 2012
(Pub. L. 112–144), which requires FDA
to review and, as appropriate, revise not
fewer than three guidance documents
per year for the conduct of clinical trials
with respect to antibacterial and
antifungal drugs.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the Agency’s
current thinking on this topic. It does
not create or confer any rights for or on
any person and does not operate to bind
FDA or the public. An alternative
approach may be used if such approach
satisfies the requirements of the
applicable statutes and regulations.
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Complicated Intra-Abdominal
Infections: Developing Drugs for
Treatment.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
treatment of complicated intraabdominal infections (cIAIs).
Specifically, this guidance addresses
FDA’s current thinking regarding the
overall drug development program for
the treatment of cIAIs, including clinical
trial designs to support approval of
drugs. This guidance finalizes the draft
guidance of the same name issued
October 1, 2012.
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: Submit written requests for
single copies of this guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Bldg., 4th
Floor, Silver Spring, MD 20993. Send
one self-addressed adhesive label to
assist that office in processing your
requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the guidance document.
Submit electronic comments on the
guidance to https://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:
Joseph G. Toerner, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
SUMMARY:
PO 00000
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]]>Agencies
[Federal Register Volume 80, Number 27 (Tuesday, February 10, 2015)]
[Notices]
[Pages 7478-7479]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-02698]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Proposed Projects
Title: Child Care Development Fund (CCDF)--Reporting Improper
Payments--Instructions for States.
OMB No.: 0970-0323.
Description: Section 2 of the Improper Payments Act of 2002
provides for estimates and reports of improper payments by Federal
agencies. Subpart K of 45 CFR, Part 98 will require States to prepare
and submit a report of errors occurring in the administration of CCDF
grant funds once every three years.
The Office of Child Care (OCC) is completing the third 3-year cycle
of case record reviews to meet the requirements for reporting under
IPIA. The current forms and instructions expire September 30, 2015. OCC
is submitting the information collection for renewal clearance with
minor changes. Responders will now have additional guidance and
clarification in the instructions and errors have been corrected. New
language incorporates requirements from the 2014 Child Care and
Development Fund Block Grant Act passed in November 2014.
Respondents: State grantees, the District of Columbia, and Puerto
Rico.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average
Instrument Number of responses per burden hours Total burden
respondents respondent per response hours
----------------------------------------------------------------------------------------------------------------
Sampling Decisions and Fieldwork Preparation 17 1 106 1802
Plan...........................................
Record Review Worksheet......................... 17 276 6.33 29,700.36
[[Page 7479]]
State Improper Authorizations for Payment Report 17 1 639 10,863
Corrective Action Plan.......................... 8 1 156 1248
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 43,613.36.
In compliance with the requirements of Section 506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
Families is soliciting public comment on the specific aspects of the
information collection described above. Copies of the proposed
collection of information can be obtained and comments may be forwarded
by writing to the Administration for Children and Families, Office of
Planning, Research and Evaluation, 370 L'Enfant Promenade SW.,
Washington, DC 20447, Attn: ACF Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All requests should be identified
by the title of the information collection.
The Department specifically requests comments on: (a) Whether the
proposed collection of information is necessary for the proper
performance of the functions of the agency, including whether the
information shall have practical utility; (b) the accuracy of the
agency's estimate of the burden of the proposed collection of
information; (c) the quality, utility, and clarity of the information
to be collected; and (d) ways to minimize the burden information to be
collected; and (d) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection techniques or other forms of information technology.
Consideration will be given to comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2015-02698 Filed 2-9-15; 8:45 am]
BILLING CODE 4184-01-P
