Submission for OMB Review; Comment Request, 58158 [2019-23635]
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58158
Federal Register / Vol. 84, No. 210 / Wednesday, October 30, 2019 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Comment Request
Title: Annual Report/ACF 204 (State
MOE) (OMB #0970–0248).
OMB No.: 0970–0248.
Description: The Administration for
Children and Families (ACF) is
requesting a three-year extension of the
ACF–204 (Annual MOE Report). The
report is used to collect descriptive
program characteristics information on
the programs operated by States and
Territories in association with their
Temporary Assistance for Needy
Families (TANF) programs. All State
and Territory expenditures claimed
toward States and Territories MOE
requirements must be appropriate, i.e.,
meet all applicable MOE requirements.
The Annual MOE Report provides the
ability to learn about and to monitor the
nature of State and Territory
expenditures used to meet States and
Territories MOE requirements, and it is
an important source of information
about the different ways that States and
Territories are using their resources to
help families attain and maintain selfsufficiency. In addition, the report is
used to obtain State and Territory
program characteristics for ACFs annual
report to Congress, and the report serves
as a useful resource to use in
Congressional hearings about how
TANF programs are evolving, in
assessing State the Territory MOE
expenditures, and in assessing the need
for legislative changes.
Respondents: The 50 States of the
United States, the District of Columbia,
Guam, Puerto Rico, and the Virgin
Islands.
ANNUAL BURDEN ESTIMATES
Instrument
Number of
respondents
Number of
responses
per
respondent
Average
burden
hours per
response
Total burden
hours
ACF–204 ..........................................................................................................
54
1
118
6,372
Estimated Total Annual Burden
Hours: 6,372.
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, 330
C Street SW, Washington, DC 20201,
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.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–23635 Filed 10–29–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–3953]
Providing Regulatory Submissions in
Electronic Format: Investigational New
Drug Application Safety Reports; 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
‘‘Providing Regulatory Submissions in
Electronic Format: IND Safety Reports.’’
The draft guidance describes the
electronic format sponsors will be
required to use when they electronically
submit to FDA investigational new drug
(IND) safety reports to the Center for
Drug Evaluation and Research (CDER) or
the Center for Biologics Evaluation and
Research (CBER) for serious and
unexpected suspected adverse reactions
that are required under the Agency’s
regulations. FDA is establishing the
electronic format requirements
described in this guidance under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act). The draft guidance, once
finalized and effective, will require
sponsors submitting the specified IND
safety reports electronically to submit
the reports to FDA using the FDA
Adverse Event Reporting System
(FAERS) as structured data elements
SUMMARY:
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Frm 00033
Fmt 4703
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and will provide sponsors with a
reporting format that is consistent with
the International Council for
Harmonisation (ICH) E2B(R2) format
guidelines and reporting requirements
to other regulatory agencies. Additional
technical specification documents and
instructions for submitting IND safety
reports, including ‘‘Electronic
Submission of IND Safety Reports
Technical Conformance Guide’’ and an
updated technical specifications
document entitled ‘‘Specifications for
Preparing and Submitting Electronic
ICSRs and ICSR Attachments’’ are
available on the FAERS Electronic
Submission web page (available at
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Surveillance/AdverseDrugEffects/
ucm115894.htm).
DATES: Submit either electronic or
written comments on the draft guidance
by December 30, 2019 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:
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
E:\FR\FM\30OCN1.SGM
30OCN1
]]>Agencies
[Federal Register Volume 84, Number 210 (Wednesday, October 30, 2019)]
[Notices]
[Page 58158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23635]
[[Page 58158]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Comment Request
Title: Annual Report/ACF 204 (State MOE) (OMB #0970-0248).
OMB No.: 0970-0248.
Description: The Administration for Children and Families (ACF) is
requesting a three-year extension of the ACF-204 (Annual MOE Report).
The report is used to collect descriptive program characteristics
information on the programs operated by States and Territories in
association with their Temporary Assistance for Needy Families (TANF)
programs. All State and Territory expenditures claimed toward States
and Territories MOE requirements must be appropriate, i.e., meet all
applicable MOE requirements. The Annual MOE Report provides the ability
to learn about and to monitor the nature of State and Territory
expenditures used to meet States and Territories MOE requirements, and
it is an important source of information about the different ways that
States and Territories are using their resources to help families
attain and maintain self-sufficiency. In addition, the report is used
to obtain State and Territory program characteristics for ACFs annual
report to Congress, and the report serves as a useful resource to use
in Congressional hearings about how TANF programs are evolving, in
assessing State the Territory MOE expenditures, and in assessing the
need for legislative changes.
Respondents: The 50 States of the United States, the District of
Columbia, Guam, Puerto Rico, and the Virgin Islands.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Instrument Number of responses per hours per Total burden
respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
ACF-204..................................... 54 1 118 6,372
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 6,372.
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, 330 C Street SW,
Washington, DC 20201, Attn: ACF Reports Clearance Officer. All requests
should be identified by the title of the information collection. Email
address: [email protected].
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: [email protected], Attn: Desk Officer for the
Administration for Children and Families.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-23635 Filed 10-29-19; 8:45 am]
BILLING CODE 4184-82-P
