Proposed Information Collection Activity; Comment Request, 25464-25465 [2018-11796]
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25464
Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices
Families, U.S. Department of Health and
Human Services, 330 C Street SW, 5th
Floor, Mail Room 5425, Washington, DC
20201.
FOR FURTHER INFORMATION CONTACT:
Lauren Christopher, Director, Division
of Energy Assistance, Office of
Community Services, Administration
for Children and Families, U.S.
Department of Health and Human
Services, 330 C Street SW, 5th Floor,
Mail Room 5425, Washington, DC
20201. Telephone: (202) 401–4870.
Email: lauren.christopher@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: It has been
determined that $536,595 in LIHEAP
funds may be available for reallotment
during FY 2018. This determination is
based on FY 2017 Carryover and
Reallotment Reports which showed that
fifteen grantees reported reallotment
funds. These grantees were State of
Alaska, Aniak Traditional Council,
Association of Village Council
Presidents, Bristol Bay Native
Association, Colorado River Indian
Tribes, Hoh Indian Tribe, Jicarilla
Apache Nation, Kalispel Tribe of
Indians, Little River Band of Ottawa
Indians, Miami Tribe of Oklahoma,
Navajo Nation, Sac and Fox Nation of
Oklahoma, Samish Indian Nation, Three
Affiliated Tribes, and Tyme Maidu
Tribe Berry Creek Rancheria. Grantees
submitted the FY 2017 Carryover and
Reallotment Reports to the OCS, as
required by regulations applicable to
LIHEAP at 45 CFR 96.81(b).
The LIHEAP statute allows grantees
who have funds unobligated at the end
of the federal fiscal year for which they
are awarded to request that they be
allowed to carry over up to 10 percent
of their full-year allotments to the next
federal fiscal year. Funds in excess of
this amount must be returned to HHS
and are subject to reallotment under
section 2607(b)(1) of the Act (42 U.S.C.
8626(b)(1)). The amount described in
this notice was reported by grantees as
unobligated FY 2017 funds in excess of
the amount that these grantees could
carry over to FY 2018.
In accordance with section 2607(b)(3)
of the Act (42 U.S.C. 8626(b)(3)),
comments will be accepted for a period
of 30 days from the date of publication
of this notice.
After considering any comments
submitted, all current LIHEAP grantees
will be notified of the final reallotment
amount redistributed to them for
obligation in FY 2018. This decision
will be published in a Dear Colleague
Letter that gets posted to ACF’s website.
If funds are reallotted, they will be
allocated in accordance with section
2604 of the Act (42 U.S.C. 8623) and
must be treated by LIHEAP grantees
receiving them as an amount
appropriated for FY 2018. As FY 2018
funds, they will be subject to all
requirements of the Act, including
section 2607(b)(2) (42 U.S.C. 8626(b)(2)),
which requires that a grantee obligate at
least 90 percent of its total block grant
allocation for a fiscal year by the end of
the fiscal year for which the funds are
appropriated, that is, by September 30,
2018.
ESTIMATED REALLOTMENT AMOUNTS
OF FY 2017 LIHEAP FUNDS
Reallotment
amount
Grantee name
State of Alaska .......................
Aniak Traditional Council ........
Association of Village Council
Presidents ...........................
Bristol Bay Native Association
Colorado River Indian Tribes
Navajo Nation .........................
Tyme Maidu Tribe Berry
Creek Rancheria .................
Little River Band of Ottawa Indians ....................................
Jicarilla Apache Nation ...........
Three Affiliated Tribes ............
Miami Tribe of Oklahoma .......
Sac and Fox Nation of Oklahoma ...................................
Hoh Indian Tribe .....................
Kalispel Tribe of Indians .........
Samish Indian Nation .............
$10,552
840
Total ........................................
Statutory Authority: 42 U.S.C. 8626.
Elizabeth Leo,
Grants Policy Specialist, Division of Grants
Policy, Office of Administration.
[FR Doc. 2018–11820 Filed 5–31–18; 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
Title: Administration for Native
Americans Annual Data Report.
OMB No. 0970–0475: Renewal.
Description: The Administration for
Native Americans is seeking renewal of
the Annual Data Report (ADR). The
ADR is an annual report to be
completed at the end of every budget
period of an ANA discretionary grant.
The purpose of this information
collection is to annually collect grantee
data on outcome indicators, youth and
elder engagement, partnerships,
community participation, benefits and
lessons learned. At the end of the
project period, ANA will also collect
data on beneficiaries, the overall
achievement of the project goal, and
project sustainability.
This information collection will be
housed in the On-Line Data Collection
(OLDC) with in GrantSolutions.gov.
Respondents: Tribal Government,
Native non-profit organizations, Tribal
Colleges & Universities receiving ANA
discretionary funding.
536,595
164,654
13,605
3,878
28,901
3
62,871
9,317
194,213
77
35,967
4,034
1,211
6,472
ANNUAL BURDEN ESTIMATES
Number of
respondents
Number of
responses per
respondent
Average
burden hours
per response
Total burden
hours
ADR .................................................................................................................
daltland on DSKBBV9HB2PROD with NOTICES
Instrument
275
1
1
275
Estimated Total Annual Burden
Hours: 275.
In compliance with the requirements
of the Paperwork Reduction Act of 1995
(Pub. L. 104–13, 44 U.S.C. Chap 35), the
Administration for Children and
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17:06 May 31, 2018
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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
PO 00000
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to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 330 C Street SW,
Washington, DC 20201, Attn: ACF
Reports Clearance Officer. Email
address: infocollection@acf.hhs.gov. All
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Federal Register / Vol. 83, No. 106 / Friday, June 1, 2018 / Notices
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.
Robert A. Sargis,
Reports Clearance Officer.
[FR Doc. 2018–11796 Filed 5–31–18; 8:45 am]
BILLING CODE 4184–34–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
[Docket No. FDA–2018–D–1043]
Waivers of the Single, Shared System
Risk Evaluation and Mitigation
Strategy Requirement; Draft Guidance
for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Waivers
of the Single, Shared System REMS
Requirement.’’ This guidance describes
how FDA intends to consider granting a
waiver of the requirement in the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) that the applicant for an
abbreviated new drug application
(ANDA) and its reference listed drug
(RLD) use a single, shared system (SSS)
for a required risk evaluation and
mitigation strategy (REMS) with
elements to assure safe use (ETASU).
DATES: Submit either electronic or
written comments on the draft guidance
by August 30, 2018 to ensure that the
Agency considers your comment on this
draft guidance before it begins work on
the final version of the guidance.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
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SUMMARY:
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17:06 May 31, 2018
Jkt 244001
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1043 for ‘‘Waivers of the
Single, Shared System Risk Evaluation
and Mitigation Strategy Requirement;
Draft Guidance for Industry;
Availability.’’ Received comments will
be placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
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25465
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
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, or to the Office of
Communication, Outreach and
Development, Center for Biologics
Evaluation and Research, 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 draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Elaine Lippmann, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6238,
Silver Spring, MD 20993, 301–796–
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]]>Agencies
[Federal Register Volume 83, Number 106 (Friday, June 1, 2018)]
[Notices]
[Pages 25464-25465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11796]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Comment Request
Title: Administration for Native Americans Annual Data Report.
OMB No. 0970-0475: Renewal.
Description: The Administration for Native Americans is seeking
renewal of the Annual Data Report (ADR). The ADR is an annual report to
be completed at the end of every budget period of an ANA discretionary
grant. The purpose of this information collection is to annually
collect grantee data on outcome indicators, youth and elder engagement,
partnerships, community participation, benefits and lessons learned. At
the end of the project period, ANA will also collect data on
beneficiaries, the overall achievement of the project goal, and project
sustainability.
This information collection will be housed in the On-Line Data
Collection (OLDC) with in GrantSolutions.gov.
Respondents: Tribal Government, Native non-profit organizations,
Tribal Colleges & Universities receiving ANA discretionary funding.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ADR......................................... 275 1 1 275
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 275.
In compliance with the requirements of the Paperwork Reduction Act
of 1995 (Pub. L. 104-13, 44 U.S.C. Chap 35), 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, 330 C Street SW,
Washington, DC 20201, Attn: ACF Reports Clearance Officer. Email
address: [email protected]. All
[[Page 25465]]
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.
Robert A. Sargis,
Reports Clearance Officer.
[FR Doc. 2018-11796 Filed 5-31-18; 8:45 am]
BILLING CODE 4184-34-P
