Submission for OMB Review; Comment Request, 12823-12824 [2015-05522]
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Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices
Rmajette on DSK2VPTVN1PROD with NOTICES
updated in accordance with the Meeting
Management Goals section of the
PDUFA Reauthorization Performance
Goals and Procedures, Fiscal Years 2013
through 2017. Significant changes from
the 2009 guidance include:
• Addition of the written response
meeting format for pre-investigational
new drug application and Type C
meetings
• Designation of a post-action meeting
requested within 3 months after an
FDA regulatory action other than
approval as a Type A meeting
• Designation of a post-action meeting
requested 3 or more months after an
FDA regulatory action other than
approval as a Type B meeting
• Designation of a meeting regarding
risk evaluation and mitigation
strategies or postmarketing
requirements that occur outside the
context of the review of a marketing
application as a Type B meeting
• Inclusion of a meeting package in
Type A meeting requests
• Designation of meetings to discuss the
overall development program for
products granted breakthrough
therapy designation status as a Type
B meeting
This draft guidance is being issued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The draft guidance, when finalized, will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 formal meetings between FDA and
sponsors or applicants of PDUFA
products. 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. The Paperwork Reduction Act of
1995
This draft guidance refers to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 referred to in
the guidance entitled ‘‘Formal Meetings
Between the FDA and Sponsors or
Applicants’’ have been approved under
OMB control number 0910–0429. The
collections of information for Form FDA
1571 and end-of-phase 2 meetings have
been approved under OMB control
number 0910–0014, and collections of
information for Form FDA 356h have
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been approved under OMB control
number 0910–0338.
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
comments. Identify comments with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday, and
will be posted to the docket at https://
www.regulations.gov.
IV. Electronic Access
Persons with access to the Internet
may obtain the document at https://
www.fda.gov/Drugs/
GuidanceComplianceRegulatory
Information/Guidances/default.htm,
https://www.fda.gov/BiologicsBlood
Vaccines/Guidance
ComplianceRegulatoryInformation/
default.htm, or https://www.
regulations.gov.
Dated: March 5, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05523 Filed 3–10–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–N–0001]
Arthritis Advisory Committee: Notice
of Postponement of Meeting
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is postponing the
meeting of the Arthritis Advisory
Committee scheduled for March 17,
2015. The meeting was announced in
the Federal Register of February 10,
2015 (80 FR 7480). The postponement is
due to information requests pending
with the sponsor of the application. A
future meeting date will be announced
in the Federal Register.
FOR FURTHER INFORMATION CONTACT:
Stephanie L. Begansky, Center for Drug
Evaluation and Research, Food and
SUMMARY:
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Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417,
Silver Spring, MD 20993–0002, 301–
796–9001, FAX: 301–847–8533, email:
AAC@fda.hhs.gov, or FDA Advisory
Committee Information Line, 1–800–
741–8138 (301–443–0572 in the
Washington, DC area). Please call the
Information Line for up-to-date
information on this meeting.
Dated: March 6, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–05527 Filed 3–10–15; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Temporary Assistance for Needy
Families Two-Parent Study.
OMB No.: New Collection.
Description: The Administration for
Children and Families (ACF) is
proposing an information collection
activity as part of the Temporary
Assistance for Needy Families TwoParent Study. Through this information
collection, ACF seeks to gain an indepth, systematic understanding of the
characteristics of two-parent families
participating in or eligible to receive
TANF, the variety of services two-parent
families receive through TANF, how
state policies may affect participation in
TANF among two-parent families, and
how the beliefs of staff and eligible
families affect two-parent families’
participation in TANF.
The proposed information collection
consists of semi-structured interviews
with key State and local staff,
community-based organization
representatives, and adult members of
two-parent TANF or likely eligible
families on questions of TANF policies,
service delivery, and program context,
as well as focus groups with adult
members of two-parent TANF or likely
eligible families.
Respondents: State- and local-level
TANF administrators and staff,
representatives from community-based
organizations, and adults from twoparent families on or likely eligible for
TANF.
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Federal Register / Vol. 80, No. 47 / Wednesday, March 11, 2015 / Notices
ANNUAL BURDEN ESTIMATES
Total/Annual
number of
respondents
Instrument
Discussion
Discussion
Discussion
Discussion
Discussion
Discussion
Guide for use with state TANF directors ......................................
Guide for use with local TANF directors .......................................
Guide for use with local TANF front-line staff ...............................
Guide for use with community-based organizations .....................
Guide for use with client focus groups .........................................
guide for use with client interviews ...............................................
Estimated Total Annual Burden
Hours: 236.
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: 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,
OPRE Reports Clearance Officer.
[FR Doc. 2015–05522 Filed 3–10–15; 8:45 am]
BILLING CODE 4184–73–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Community Living
Applications for New Awards; National
Institute on Disability, Independent
Living, and Rehabilitation Research—
Advanced Rehabilitation Research
Training Program
10
5
15
5
112
25
Rehabilitation Research Training
(ARRT) Program.
Notice inviting applications for new
awards for fiscal year (FY) 2015.
Catalog of Federal Domestic Assistance
(CFDA) Numbers: 84.133P–1, 84.133P–3, and
84–133P–4.
Note: This notice invites applications for
three separate competitions. See the chart in
the Award Information section of this notice
for funding and other key information for
each of the three competitions.
DATES:
Applications Available: March 11,
2015.
Note: On July 22, 2014, President Obama
signed the Workforce Innovation
Opportunity Act (WIOA). WIOA was
effective immediately. One provision of
WIOA transferred the National Institute on
Disability and Rehabilitation Research
(NIDRR) from the Department of Education to
the Administration for Community Living
(ACL) in the Department of Health and
Human Services. In addition, NIDRR’s name
was changed to the Institute on Disability,
Independent Living, and Rehabilitation
Research (NIDILRR). For FY 2015, all
NIDILRR priority notices will be published as
ACL notices, and ACL will make all NIDILRR
awards. During this transition period,
however, NIDILRR will continue to review
grant applications using Department of
Education tools. NIDILRR will post
previously-approved application kits to
grants.gov, and NIDILRR applications
submitted to grants.gov will be forwarded to
the Department of Education’s G–5 system
for peer review. We are using Department of
Education application kits and peer review
systems during this transition year in order
to provide for a smooth and orderly process
for our applicants.
Date of Pre-Application Meeting:
April 1, 2015.
Deadline for Transmittal of
Applications: May 11, 2015.
Rmajette on DSK2VPTVN1PROD with NOTICES
AGENCY:
Full Text of Announcement
Overview Information
National Institute on Disability,
Independent Living, and Rehabilitation
Research (NIDILRR)—Advanced
I. Funding Opportunity Description
Purpose of Program: The purpose of
the Disability and Rehabilitation
Research Projects and Centers Program
is to plan and conduct research,
demonstration projects, training, and
related activities, including
international activities, to develop
Administration for Community
Living, Department of Health and
Human Services.
ACTION: Notice.
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Number of
responses per
respondent
1
1
1
1
1
1
Average
burden hours
per response
1.5
1.5
1
1
1.5
1
Annual burden
hours
15
8
15
5
168
25
methods, procedures, and rehabilitation
technology. The Program’s activities are
designed to maximize the full inclusion
and integration into society,
employment, independent living, family
support, and economic and social selfsufficiency of individuals with
disabilities, especially individuals with
the most severe disabilities, and to
improve the effectiveness of services
authorized under the Rehabilitation Act
of 1973, as amended (Rehabilitation
Act).
Advanced Rehabilitation Research
Training Program
The purpose of NIDILRR’s ARRT
program, which is funded through the
Disability and Rehabilitation Research
Projects and Centers Program, is to
provide advanced research training and
experience to individuals with
doctorates, or similar advanced degrees,
who have clinical or other relevant
experience. ARRT projects train
rehabilitation researchers, including
researchers with disabilities, with
particular attention to research areas
that support the implementation and
objectives of the Rehabilitation Act, and
that improve the effectiveness of
services authorized under the
Rehabilitation Act.
Additional information on the ARRT
program can be found at: www.ed.gov/
rschstat/research/pubs/resprogram.html#ARRT.
Priority: There is one priority for the
three competitions, which will each
address one of NIDILRR’s major
domains of individual well-being: (a)
Community living and participation, (b)
employment, or (c) health and function.
This priority is from the notice of final
priority for this program, published in
the Federal Register on June 11, 2013
(78 FR 34901).
Absolute Priority: For FY 2015 and
any subsequent year in which we make
awards from the list of unfunded
applicants from these competitions, this
priority is an absolute priority for each
of the three competitions. Under 45 CFR
part 75 we consider only applications
that meet this program priority.
This priority is:
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[Federal Register Volume 80, Number 47 (Wednesday, March 11, 2015)]
[Notices]
[Pages 12823-12824]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-05522]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Temporary Assistance for Needy Families Two-Parent Study.
OMB No.: New Collection.
Description: The Administration for Children and Families (ACF) is
proposing an information collection activity as part of the Temporary
Assistance for Needy Families Two-Parent Study. Through this
information collection, ACF seeks to gain an in-depth, systematic
understanding of the characteristics of two-parent families
participating in or eligible to receive TANF, the variety of services
two-parent families receive through TANF, how state policies may affect
participation in TANF among two-parent families, and how the beliefs of
staff and eligible families affect two-parent families' participation
in TANF.
The proposed information collection consists of semi-structured
interviews with key State and local staff, community-based organization
representatives, and adult members of two-parent TANF or likely
eligible families on questions of TANF policies, service delivery, and
program context, as well as focus groups with adult members of two-
parent TANF or likely eligible families.
Respondents: State- and local-level TANF administrators and staff,
representatives from community-based organizations, and adults from
two-parent families on or likely eligible for TANF.
[[Page 12824]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Total/Annual Number of Average burden
Instrument number of responses per hours per Annual burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Discussion Guide for use with state TANF 10 1 1.5 15
directors......................................
Discussion Guide for use with local TANF 5 1 1.5 8
directors......................................
Discussion Guide for use with local TANF front- 15 1 1 15
line staff.....................................
Discussion Guide for use with community-based 5 1 1 5
organizations..................................
Discussion Guide for use with client focus 112 1 1.5 168
groups.........................................
Discussion guide for use with client interviews. 25 1 1 25
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 236.
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: 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,
OPRE Reports Clearance Officer.
[FR Doc. 2015-05522 Filed 3-10-15; 8:45 am]
BILLING CODE 4184-73-P
