Proposed Information Collection Activity; Comment Request, 32666-32667 [2013-12904]
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Federal Register / Vol. 78, No. 105 / Friday, May 31, 2013 / Notices
Dated: May 23, 2013.
Marilyn Tavenner,
Administrator, Centers for Medicare &
Medicaid Services.
OMB No.: 0970–0034.
Description: The two reports collect
information necessary to administer the
Unaccompanied Refugee Minor (URM)
program. The ORR–3 (Placement
Report) is submitted to the Office of
Refugee Resettlement (ORR) by the State
agency at initial placement within 30
days of the placement, and whenever
there is a change in the child’s status,
including termination from the program,
within 60 days of the change or closure
of the case. The ORR–4 (Outcomes
Report) is submitted within
approximately 12 months of the initial
placement and each subsequent 12
months to record outcomes of the
child’s progress toward the goals listed
in the child’s case plan and particularly
[FR Doc. 2013–12953 Filed 5–30–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Unaccompanied Refugee Minor
Placement and Outcomes Reports; ORR–
3 and ORR–4.
for youth 17 years of age and above
related to independent living and/or
educational plans. ORR–4 is also
submitted as a baseline report along
with the initial ORR–3 report for 17
years old and above youth, and as a
follow-up annual report for cases that
have terminated and are 17 to 21 years
old. ORR regulations at 45 CFR 400.120
describes specific URM program
reporting requirements.
Respondents: State governments.
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Average
burden hours
per response
Estimate responses 75 ................
Estimate responses 119 ..............
0.25 (15 Minutes) ......................
1.5 (1 Hour and 30 Minutes) .....
Number of
respondents
Instrument
ORR–3 .......................................
ORR–4 .......................................
15
15
Estimated Total Annual Burden
Hours: 2,958.75.
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: ACF Reports Clearance
Officer. All requests should be
identified by the title of the information
collection. Email address:
infocollection@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: 202–395–7285,
Email:
OIRA_SUBMISSION@OMB.EOP.GOV.
Attn: Desk Officer for the
Administration for Children and
Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2013–12875 Filed 5–30–13; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Comment Request
Total burden hours
Estimated 281.25
Estimated 2,677.5
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF) is
proposing an information collection
activity as part of the Job Search
Assistance (JSA) Strategies Evaluation.
The proposed information collection
consists of semi-structured interviews
with key respondents involved with job
search assistance programs in states and
localities. Through this information
collection and other study activities,
ACF seeks to identify the types of job
search assistance strategies that should
be tested within the context of current
TANF policies and requirements.
Respondents: State and local TANF
administrators, program staff, and
stakeholders such as researchers and
policy experts.
Title: Job Search Assistance (JSA)
Strategies Evaluation.
ANNUAL BURDEN ESTIMATES
Total number
of
respondents
tkelley on DSK3SPTVN1PROD with NOTICES
Instrument
Discussion Guide for Use with Researchers and Policy
Experts .......................................................................
Discussion Guide for use with State and Local TANF
Administrators .............................................................
Discussion Guide for Use with Program Staff ...............
Estimated Total Annual Burden
Hours: 101.25.
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Number of
responses per
respondent
Average
burden hours
per response
Total
burden hours
Annual
burden hours
15
1
1
15
7.5
35
50
1
1
2.5
2
87.5
100
43.75
50
In compliance with the requirements
of Section 3506(c)(2)(A) of the
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Paperwork Reduction Act of 1995, the
Administration for Children and
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Federal Register / Vol. 78, No. 105 / Friday, May 31, 2013 / Notices
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: OPRE Reports Clearance Officer.
Email address:
OPREinfocollection@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 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.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2013–12904 Filed 5–30–13; 8:45 am]
BILLING CODE 4184–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0571]
Draft Guidance for Industry on
Rheumatoid Arthritis: Developing Drug
Products for Treatment; Availability
AGENCY:
Food and Drug Administration,
HHS.
tkelley on DSK3SPTVN1PROD with NOTICES
ACTION:
Notice.
SUMMARY: The Food and Drug
Administration (FDA) is announcing the
availability of a draft guidance for
industry entitled ‘‘Rheumatoid Arthritis:
Developing Drug Products for
Treatment.’’ This guidance outlines
FDA’s current thinking on the
principles of clinical development
relevant to dose-selection and
assessment of efficacy and safety to
support the approval of drug products
for the treatment of patients with
rheumatoid arthritis (RA). It also
addresses additional considerations for
VerDate Mar<15>2010
17:40 May 30, 2013
Jkt 229001
drug products developed as drug-device
combination products. This guidance
revises the guidance for industry
entitled ‘‘Clinical Development
Programs for Drugs, Devices, and
Biological Products for the Treatment of
Rheumatoid Arthritis (RA),’’ published
in February 1999.
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 July 30, 2013.
DATES:
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, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201,
Silver Spring, MD 20993–0002; or 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 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://
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Nikolay Nikolov, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 3335,
Silver Spring, MD 20993–0002, 301–
796–5281; 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 Markham Luke Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, Rm.
1680, Silver Spring, MD 20993–0002,
301–796–5556.
SUPPLEMENTARY INFORMATION:
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32667
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Rheumatoid Arthritis: Developing Drug
Products for Treatment.’’ This draft
guidance reflects current FDA thinking
on RA drug product development.
FDA’s current thinking has been
influenced by clinical development
programs conducted for RA since the
1999 guidance published, and by
changes in the standard of care for RA
because of availability of many effective
treatments. RA drug product
development has evolved to reflect the
current status of the RA therapeutic
armamentarium, good clinical practice,
and treatment goals.
The draft guidance addresses:
• Dose(s) and dosing regimen(s)
selection throughout the clinical
development program.
• Expectations for establishing
efficacy in RA based on signs and
symptoms and physical function
domains.
• Use of efficacy endpoints such as
clinical remission and prevention of
structural damage progression.
• Limiting the use of placebo.
• Use of active comparator for safety
and efficacy trials.
• Principles of safety assessment.
• Development of drug-device
combination products.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the Agency’s current thinking
on developing drug products for the
treatment of RA. 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.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information that
are subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3520). The collections
of information in 21 CFR parts 312 and
314 have been approved under OMB
control numbers 0910–0014 and 0910–
0001, respectively.
III. Comments
Interested persons may submit either
electronic comments regarding this
document to https://www.regulations.gov
or written comments to the Division of
Dockets Management (see ADDRESSES). It
is only necessary to send one set of
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]]>Agencies
[Federal Register Volume 78, Number 105 (Friday, May 31, 2013)]
[Notices]
[Pages 32666-32667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-12904]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Job Search Assistance (JSA) Strategies Evaluation.
OMB No.: New Collection.
Description: The Administration for Children and Families (ACF) is
proposing an information collection activity as part of the Job Search
Assistance (JSA) Strategies Evaluation. The proposed information
collection consists of semi-structured interviews with key respondents
involved with job search assistance programs in states and localities.
Through this information collection and other study activities, ACF
seeks to identify the types of job search assistance strategies that
should be tested within the context of current TANF policies and
requirements.
Respondents: State and local TANF administrators, program staff,
and stakeholders such as researchers and policy experts.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Total number responses per hours per Total burden Annual burden
of respondents respondent response hours hours
----------------------------------------------------------------------------------------------------------------
Discussion Guide for Use with 15 1 1 15 7.5
Researchers and Policy
Experts......................
Discussion Guide for use with 35 1 2.5 87.5 43.75
State and Local TANF
Administrators...............
Discussion Guide for Use with 50 1 2 100 50
Program Staff................
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 101.25.
In compliance with the requirements of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the Administration for Children and
[[Page 32667]]
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: OPRE Reports Clearance Officer. Email
address: OPREinfocollection@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 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.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2013-12904 Filed 5-30-13; 8:45 am]
BILLING CODE 4184-09-P
