Proposed Information Collection Activity; Comment Request; State Developmental Disabilities Council-Annual Program Performance Report (PPR), 32960-32961 [2015-14051]
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32960
Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices
subject to reallotment. The 1994
reauthorization of the LIHEAP statute,
the Human Service Amendments of
1994 (Pub. L. 103–252), requires that the
Carryover and Reallotment Report for
one fiscal year be submitted to HHS via
the On-Line Data Collection (OLDC)
system by the grantee before the
allotment for the next fiscal year may be
awarded.
The Administration for Children and
Families is requesting no changes in the
electronic collection of data with the
Carryover and Reallotment Report, and
the Simplified Instructions for Timely
Obligations of LIHEAP Funds and
Reporting Funds for Carryover and
Reallotment. The form clarifies the
information being requested and
ensures the submission of all the
required information. The form
facilitates our response to numerous
queries each year concerning the
amounts of obligated funds. Use of the
form is voluntary. Grantees have the
option to use another format.
Respondents: State Governments,
Tribal Governments, Insular Areas, the
District of Columbia, and the
Commonwealth of Puerto Rico.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
Carryover and Reallotment Report ..................................................................
216
1
3
648
Estimated Total Annual Burden
Hours: 648
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. 2015–14149 Filed 6–9–15; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
asabaliauskas on DSK5VPTVN1PROD with NOTICES
Administration on Community Living
Proposed Information Collection
Activity; Comment Request; State
Developmental Disabilities Council—
Annual Program Performance Report
(PPR)
Administration for Community
Living, Administration on Intellectual
and Developmental Disabilities, HHS.
AGENCY:
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ACTION:
Notice.
A Plan developed by the State
Council on Developmental Disabilities
is required by federal statute. Each State
Council on Developmental Disabilities
must develop the plan, provide for
public comments in the State, provide
for approval by the State’s Governor,
and finally submit the plan on a fiveyear basis. On an annual basis, the
Council must submit a Program
Performance Report (PPR) to described
the extent to which annual progress is
being achieved on the 5 year state plan
goals. The PPR will be used by (1) the
Council as a planning document to track
progress made in meeting state plan
goals; (2) the citizenry of the State as a
mechanism for monitoring progress and
activities on the plans of the Council; (3)
the Department as a stewardship tool,
for ensuring compliance with the
Developmental Disabilities Assistance
and Bill of Rights Act, as one basis for
monitoring and providing technical
assistance (e.g., during site visits), and
as a support for management decision
making.
DATES: Submit written comments on the
collection of information by August 10,
2015.
ADDRESSES: Submit written comments
on the collection of information by
email to: allison.cruz@acl.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
Allison Cruz, Administration on
Community Living, Administration on
Intellectual and Developmental
Disabilities, Office of Program Support,
One Massachusetts Avenue NW., Room
4306, Washington, DC 20201, 202–357–
3439.
SUPPLEMENTARY INFORMATION: In
compliance with the requirements of
section 506(c)(2)(A) of the Paperwork
Reduction Act of 1995, the
Administration on Community Living is
SUMMARY:
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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: Allison Cruz,
Administration on Community Living,
Administration on Intellectual and
Developmental Disabilities, Office of
Program, One Massachusetts Avenue
NW., Room 4306, Washington, DC
20201.
The Department specifically requests
comments on: (a) Whether the proposed
Collection of information is necessary
for the proper performance of the
function 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; (d) ways to
minimize the burden information to be
collected; and (e) ways to minimize the
burden of the collection of information
on respondents, including through the
use of automated collection technique
comments and or other forms of
information technology. Consideration
will be given to comments and
suggestions submitted within 60 days of
this publication.
Respondents
56 State Developmental Disabilities
Councils.
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Federal Register / Vol. 80, No. 111 / Wednesday, June 10, 2015 / Notices
ANNUAL BURDEN ESTIMATES
Number of
responses per
respondent
Number of
respondents
Instrument
Average
burden hours
per response
Total burden
hours
State Developmental Disabilities Program Performance Report (PPR) .........
56
1
138
7,728
Estimated Total Annual Burden Hours: ....................................................
........................
........................
........................
7,728
Dated: June 3, 2015.
Kathy Greenlee,
Administrator and Assistant Secretary for
Aging.
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:
Colleen Locicero, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 4242,
Silver Spring, MD 20993–0002, 301–
796–1114.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2015–14051 Filed 6–9–15; 8:45 am]
BILLING CODE 4154–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2015–D–1884]
Duchenne Muscular Dystrophy and
Related Dystrophinopathies:
Developing Drugs for Treatment; Draft
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled
‘‘Duchenne Muscular Dystrophy and
Related Dystrophinopathies: Developing
Drugs for Treatment.’’ The purpose of
this draft guidance is to assist sponsors
in the clinical development of drugs for
the treatment of X-linked Duchenne
muscular dystrophy (DMD) and related
dystrophinopathies.
DATES: 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 August 10,
2015.
ADDRESSES: Submit written requests for
single copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, 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://
asabaliauskas on DSK5VPTVN1PROD with NOTICES
SUMMARY:
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I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Duchenne Muscular Dystrophy and
Related Dystrophinopathies: Developing
Drugs for Treatment.’’
DMD and other dystrophinopathies
result from genetic mutations in the
dystrophin gene that decrease levels of
dystrophin and/or cause dysfunction of
the dystrophin protein, leading to
muscle degeneration, including cardiac
and respiratory muscles, and greatly
decreased life expectancy. There
remains a high level unmet medical
need for effective drug treatments for
DMD and other dystrophinopathies.
This draft guidance addresses FDA’s
current thinking regarding the clinical
development program and clinical trial
designs for drugs to support an
indication for the treatment of
dystrophinopathies. Development of
this draft guidance was greatly
facilitated by the efforts of Parent
Project Muscular Dystrophy to
coordinate a consortium of stakeholders
including patients, parents and
caregivers, clinicians, academic experts,
and industry representatives in
producing a proposed draft guidance
with extensive background information
about DMD. That stakeholder proposal
was submitted to FDA and made
available for comment through a
Federal Register notice seeking public
comment. The comments received were
also considered in writing this draft
guidance.
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 current thinking of FDA
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on developing drugs for the treatment of
DMD. It does not establish any rights for
any person and is not binding on FDA
or the public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. The 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
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 either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: June 4, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–14100 Filed 6–9–15; 8:45 am]
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]]>Agencies
[Federal Register Volume 80, Number 111 (Wednesday, June 10, 2015)]
[Notices]
[Pages 32960-32961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14051]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration on Community Living
Proposed Information Collection Activity; Comment Request; State
Developmental Disabilities Council--Annual Program Performance Report
(PPR)
AGENCY: Administration for Community Living, Administration on
Intellectual and Developmental Disabilities, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: A Plan developed by the State Council on Developmental
Disabilities is required by federal statute. Each State Council on
Developmental Disabilities must develop the plan, provide for public
comments in the State, provide for approval by the State's Governor,
and finally submit the plan on a five-year basis. On an annual basis,
the Council must submit a Program Performance Report (PPR) to described
the extent to which annual progress is being achieved on the 5 year
state plan goals. The PPR will be used by (1) the Council as a planning
document to track progress made in meeting state plan goals; (2) the
citizenry of the State as a mechanism for monitoring progress and
activities on the plans of the Council; (3) the Department as a
stewardship tool, for ensuring compliance with the Developmental
Disabilities Assistance and Bill of Rights Act, as one basis for
monitoring and providing technical assistance (e.g., during site
visits), and as a support for management decision making.
DATES: Submit written comments on the collection of information by
August 10, 2015.
ADDRESSES: Submit written comments on the collection of information by
email to: allison.cruz@acl.hhs.gov.
FOR FURTHER INFORMATION CONTACT: Allison Cruz, Administration on
Community Living, Administration on Intellectual and Developmental
Disabilities, Office of Program Support, One Massachusetts Avenue NW.,
Room 4306, Washington, DC 20201, 202-357-3439.
SUPPLEMENTARY INFORMATION: In compliance with the requirements of
section 506(c)(2)(A) of the Paperwork Reduction Act of 1995, the
Administration on Community Living 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: Allison Cruz, Administration on
Community Living, Administration on Intellectual and Developmental
Disabilities, Office of Program, One Massachusetts Avenue NW., Room
4306, Washington, DC 20201.
The Department specifically requests comments on: (a) Whether the
proposed Collection of information is necessary for the proper
performance of the function 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; (d) ways to minimize the burden information to be
collected; and (e) ways to minimize the burden of the collection of
information on respondents, including through the use of automated
collection technique comments and or other forms of information
technology. Consideration will be given to comments and suggestions
submitted within 60 days of this publication.
Respondents
56 State Developmental Disabilities Councils.
[[Page 32961]]
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
State Developmental Disabilities Program 56 1 138 7,728
Performance Report (PPR).......................
---------------------------------------------------------------
Estimated Total Annual Burden Hours:........ .............. .............. .............. 7,728
----------------------------------------------------------------------------------------------------------------
Dated: June 3, 2015.
Kathy Greenlee,
Administrator and Assistant Secretary for Aging.
[FR Doc. 2015-14051 Filed 6-9-15; 8:45 am]
BILLING CODE 4154-01-P
