Submission for OMB Review; Comment Request, 31116-31117 [2014-12498]
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31116
Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Notices
information form, which will collect
demographic data and information on
the respondent’s work and education
history.
Follow-Up Surveys. Follow-up
telephone surveys will be conducted
with all participants. There will be three
follow-up surveys in each of the STED
and ETJD sites (including the two sites
that are also part of ETJD),
approximately 6, 12, and 30 months
after study entry.
Implementation Research and Site
Visits. Data on the context for the
programs and their implementation is
collected during two rounds of site
visits to each of the twelve sites,
including interviews, focus groups,
observations, and case file reviews.
These data will be supplemented by
short questionnaires for program staff,
clients, worksite supervisors, and
participating employers, as well as a
time study for program staff.
This notice is specific to the request
for approval of the 30-month survey,
which will measure the differences in
employment, wage progression, income,
and other outcomes between the
program groups and similar group of
respondents who were randomly
assigned to a control group. The
information collection request will also
include increased burden hours to
include additional respondents. This
increase is a result of the actual
enrollment numbers at recruited sites.
Respondents: Study participants in
the treatment and control groups.
ANNUAL BURDEN ESTIMATES—NEW INSTRUMENT
Instrument
Total
number of
respondents
Annual
number of
respondents
Number of
responses
per
respondent
Average
burden
hour per
response
Total
annual
burden
hours 1
Participant 30-month survey ................................................
11,840
3,947
1
.5
1,974
ANNUAL BURDEN ESTIMATES—CHANGES TO ESTIMATED NUMBER OF RESPONDENTS
[Instruments previously approved]
Updates to
annual
number
respondents
Number of
responses
per
respondent
Average
burden
hour per
response
Updated
annual
burden
hours 1
Previously approved instrument
Updates to total number of respondents
Participant Contact Information Form (5
STED sites).
Participant Baseline Information Form (5
STED sites).
Participant STED tracking letters ...........
Participant 6-month survey (Adult sites)
Participant 6-month survey (Young Adult
sites).
Participant 12-month survey (Adult sites)
Participant 12-month survey (Young
Adult sites).
2800 additional respondents ....
933
1
.08
75
2800 additional respondents ....
933
1
.17
159
2178 additional respondents ....
960 additional respondents ......
960 fewer respondents .............
726
320
–320
5
1
1
.05
.5
.5
182
160
–160
1440 additional respondents ....
800 additional respondents ......
480
267
1
1
.75
.75
360
200
mstockstill on DSK4VPTVN1PROD with NOTICES
Increase in Est. Annual Burden Hours for Previously Approved ICs: 976.
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. Email 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:
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18:23 May 29, 2014
Jkt 232001
Office of Management and Budget,
Paperwork Reduction Project,
Email: OIRA_SUBMISSION@
OMB.EOP.GOV, Attn: Desk Officer for
the Administration for Children and
Families.
Karl Koerper,
Reports Clearance Officer.
[FR Doc. 2014–12552 Filed 5–29–14; 8:45 am]
BILLING CODE 4184–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: DRA TANF Final Rule.
PO 00000
Frm 00039
Fmt 4703
Sfmt 4703
OMB No.: 0970–0338.
Description: When the Deficit
Reduction Act of 2005 (DRA)
reauthorized the Temporary Assistance
for Needy Families (TANF) program, it
imposed a new data requirement that
States prepare and submit data
verification procedures and replaced
other data requirements with new
versions including: the TANF Data
Report, the SSP–MOE Data Report, the
Caseload Reduction Documentation
Process, and the Reasonable Cause/
Corrective Compliance Documentation
Process. The Department of Health and
Human Services Appropriations Act,
P.L. 113–76 extended the TANF
program through September 2014. We
are proposing to continue these
information collections without change.
Respondents: States, Territories and
Tribes.
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31117
Federal Register / Vol. 79, No. 104 / Friday, May 30, 2014 / Notices
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
Preparation and Submission of Data Verification Procedures §§ 261.60–
261.63 ..........................................................................................................
Caseload Reduction Documentation Process, ACF–202 §§ 261.41 & 261.44
Reasonable Cause/Corrective Compliance Documentation Process
§§ 262.4, 262.6, & 262.7; § 261.51 ..............................................................
TANF Data Report Part 265 ............................................................................
SSP–MOE Data Report Part 265 ....................................................................
Estimated Total Annual Burden Hours .....................................................
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, Email: OIRA_
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014–12498 Filed 5–29–14; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–D–0575]
mstockstill on DSK4VPTVN1PROD with NOTICES
Guidance for Industry on Expedited
Programs for Serious Conditions—
Drugs and Biologics; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
availability of a guidance for industry
entitled ‘‘Expedited Programs for
Serious Conditions—Drugs and
SUMMARY:
VerDate Mar<15>2010
18:23 May 29, 2014
Jkt 232001
Frm 00040
Fmt 4703
Average
burden hours
per response
Total burden
hours
54
54
1
1
640
120
34,560
6,480
54
54
29
2
4
4
240
2,201
714
25,920
475,416
82,824
........................
........................
........................
625,200
Biologics.’’ The purpose of this
guidance is to provide a single resource
for information on FDA’s policies and
procedures related to expedited drug
development and review programs. The
following programs are intended to
facilitate and expedite development and
review of new drugs to address unmet
medical need in the treatment of a
serious or life-threatening condition
(expedited programs): Fast track
designation, breakthrough therapy
designation, accelerated approval, and
priority review designation. This
guidance finalizes the draft guidance
issued in June 2013.
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 (CDER),
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm.
2201, Silver Spring, MD 20993–0002; or
the Office of Communication, Outreach
and Development, Center for Biologics
Evaluation and Research (CBER), Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128,
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 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:
Melissa Robb, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6360,
Silver Spring, MD 20993–0002, 301–
796–2500; or Stephen Ripley, Center for
Biologics Evaluation and Research,
PO 00000
Number of
responses per
respondent
Sfmt 4703
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Silver
Spring, MD 20993–0002, 240–402–7911.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a guidance for industry entitled
‘‘Expedited Programs for Serious
Conditions—Drugs and Biologics.’’ This
guidance provides a single resource for
information on FDA’s policies and
procedures related to the following
expedited programs for serious
conditions: (1) Fast track designation,
(2) breakthrough therapy designation,
(3) accelerated approval, and (4) priority
review designation. The guidance
describes threshold criteria generally
applicable to expedited programs,
including what is meant by serious
condition, unmet medical need, and
available therapy. This guidance also
discusses considerations for expedited
development and review such as
manufacturing and product quality,
nonclinical studies, and clinical
inspections. In addition, this guidance
aligns CDER’s criteria for priority review
designation with CBER’s criteria. Only
products intended to treat a serious
condition are eligible for priority review
(unless otherwise eligible under specific
statutory provisions).
For over 30 years, expediting the
availability of promising therapies to
patients with serious conditions has
been a priority for FDA. With the
passage of the Food and Drug
Administration Safety and Innovation
Act (FDASIA) (Public Law 112–122),
FDA is expanding its efforts to expedite
development and review of therapies
intended to treat patients with serious
conditions. This guidance is intended to
satisfy the statutory requirements of
sections 901(c)(2) and 902(b)(1)(A) of
FDASIA.
Section 901(c)(2) of FDASIA requires
FDA to issue a final guidance document
to implement amendments to the
Federal Food, Drug, and Cosmetic Act
(the FD&C Act) made by section 901 of
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]]>Agencies
[Federal Register Volume 79, Number 104 (Friday, May 30, 2014)]
[Notices]
[Pages 31116-31117]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-12498]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: DRA TANF Final Rule.
OMB No.: 0970-0338.
Description: When the Deficit Reduction Act of 2005 (DRA)
reauthorized the Temporary Assistance for Needy Families (TANF)
program, it imposed a new data requirement that States prepare and
submit data verification procedures and replaced other data
requirements with new versions including: the TANF Data Report, the
SSP-MOE Data Report, the Caseload Reduction Documentation Process, and
the Reasonable Cause/Corrective Compliance Documentation Process. The
Department of Health and Human Services Appropriations Act, P.L. 113-76
extended the TANF program through September 2014. We are proposing to
continue these information collections without change.
Respondents: States, Territories and Tribes.
[[Page 31117]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Preparation and Submission of Data Verification 54 1 640 34,560
Procedures Sec. Sec. 261.60-261.63..........
Caseload Reduction Documentation Process, ACF- 54 1 120 6,480
202 Sec. Sec. 261.41 & 261.44...............
Reasonable Cause/Corrective Compliance 54 2 240 25,920
Documentation Process Sec. Sec. 262.4,
262.6, & 262.7; Sec. 261.51..................
TANF Data Report Part 265....................... 54 4 2,201 475,416
SSP-MOE Data Report Part 265.................... 29 4 714 82,824
---------------------------------------------------------------
Estimated Total Annual Burden Hours......... .............. .............. .............. 625,200
----------------------------------------------------------------------------------------------------------------
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, Email: OIRA_SUBMISSION@OMB.EOP.GOV, Attn: Desk Officer for the Administration for
Children and Families.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2014-12498 Filed 5-29-14; 8:45 am]
BILLING CODE 4184-01-P
