Submission for OMB Review; OCSE-75 Tribal Child Support Enforcement Program Annual Data Report (OMB #0970-0320), 69746-69747 [2019-27423]
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Federal Register / Vol. 84, No. 244 / Thursday, December 19, 2019 / Notices
Comments must be received by
February 18, 2020.
ADDRESSES: When commenting, please
reference the document identifier or
OMB control number. To be assured
consideration, comments and
recommendations must be submitted in
any one of the following ways:
1. Electronically. You may send your
comments electronically to https://
www.regulations.gov. Follow the
instructions for ‘‘Comment or
Submission’’ or ‘‘More Search Options’’
to find the information collection
document(s) that are accepting
comments.
2. By regular mail. You may mail
written comments to the following
address: CMS, Office of Strategic
Operations and Regulatory Affairs,
Division of Regulations Development,
Attention: Document Identifier/OMB
Control Number ll, Room C4–26–05,
7500 Security Boulevard, Baltimore,
Maryland 21244–1850.
To obtain copies of a supporting
statement and any related forms for the
proposed collection(s) summarized in
this notice, you may make your request
using one of following:
1. Access CMS’ website address at
website address at https://www.cms.gov/
Regulations-and-Guidance/Legislation/
PaperworkReductionActof1995/PRAListing.html.
2. Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov.
3. Call the Reports Clearance Office at
(410) 786–1326.
FOR FURTHER INFORMATION CONTACT:
William N. Parham at (410) 786–4669.
SUPPLEMENTARY INFORMATION:
DATES:
Contents
This notice sets out a summary of the
use and burden associated with the
following information collections. More
detailed information can be found in
each collection’s supporting statement
and associated materials (see
ADDRESSES).
lotter on DSKBCFDHB2PROD with NOTICES
CMS–10302 Collection Requirements
for Compendia for Determination of
Medically-Accepted Indications for Offlabel Uses of Drugs and Biologicals in
an Anti-Cancer Chemotherapeutic
Regimen
Under the PRA (44 U.S.C. 3501–
3520), federal agencies must obtain
approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
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or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Collection
Requirements for Compendia for
Determination of Medically-accepted
Indications for Off-label Uses of Drugs
and Biologicals in an Anti-cancer
Chemotherapeutic Regimen; Use:
Section 182(b) of the Medicare
Improvement of Patients and Providers
Act (MIPPA) amended section
1861(t)(2)(B) of the Social Security Act
(42 U.S.C. 1395x(t)(2)(B)) by adding at
the end the following new sentence: ‘On
and after January 1, 2010, no compendia
may be included on the list of
compendia under this subparagraph
unless the compendia has a publicly
transparent process for evaluating
therapies and for identifying potential
conflicts of interest.’ We believe that the
implementation of this statutory
provision that compendia have a
‘‘publicly transparent process for
evaluating therapies and for identifying
potential conflicts of interests’’ is best
accomplished by amending 42 CFR
414.930 to include the MIPPA
requirements and by defining the key
components of publicly transparent
processes for evaluating therapies and
for identifying potential conflicts of
interests.
All currently listed compendia will be
required to comply with these
provisions, as of January 1, 2010, to
remain on the list of recognized
compendia. In addition, any
compendium that is the subject of a
future request for inclusion on the list
of recognized compendia will be
required to comply with these
provisions. No compendium can be on
the list if it does not fully meet the
standard described in section
1861(t)(2)(B) of the Act, as revised by
section 182(b) of the MIPPA. Form
Number: CMS–10302 (OMB control
number: 0938–1078); Frequency:
Annually; Affected Public: Business and
other for-profits and Not-for-profit
institutions; Number of Respondents:
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845; Total Annual Responses: 900; Total
Annual Hours: 5,135. (For policy
questions regarding this collection
contact Sarah Fulton at 410–786–2749.)
Dated: December 16, 2019.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2019–27385 Filed 12–18–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review; OCSE–
75 Tribal Child Support Enforcement
Program Annual Data Report (OMB
#0970–0320)
Office of Child Support
Enforcement, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
AGENCY:
The Office of Child Support
Enforcement (OCSE), Administration for
Children and Families (ACF), U.S.
Department of Health and Human
Services (HHS), is requesting a threeyear extension of the form OCSE–75—
Tribal Child Support Enforcement
Annual Data Report (OMB # 0970–0320,
expiration 03/31/2020). There are no
changes requested to the form.
DATES: Comments due within 30 days of
publication. 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.
ADDRESSES: 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.
Copies of the proposed collection may
be obtained by emailing infocollection@
acf.hhs.gov. Alternatively, copies can
also 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,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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Federal Register / Vol. 84, No. 244 / Thursday, December 19, 2019 / Notices
Description: The data collected by
form OCSE–75 are used to prepare the
OCSE preliminary and annual data
reports. In addition, Tribes
administering CSE programs under Title
IV–D of the Social Security Act are
required to report program status and
accomplishments in an annual narrative
report and submit the OCSE–75 report
annually.
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Respondents: Tribal Child Support
Enforcement Organizations or the
Department/Agency/Bureau responsible
for Child Support Enforcement in each
tribe.
ANNUAL BURDEN ESTIMATES
Instrument
Annual
number of
respondents
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual
burden
hours
OCSE–75 .........................................................................................................
60
1
60
3,600
Estimated Total Annual Burden
Hours: 3,600.
FOR FURTHER INFORMATION CONTACT:
Authority: Title IV–D of the Social Security
ACT as required by CFR 45 Section
309.170(b).
Mary B. Jones,
ACF/OPRE Certifying Officer.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
[FR Doc. 2019–27423 Filed 12–18–19; 8:45 am]
BILLING CODE 4184–41–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Protection of Human Subjects; Informed
Consent; and Institutional Review
Boards—21 CFR Parts 50 and 56
Food and Drug Administration
OMB Control Numbers 0910–0755 and
0910–0130—Revision
[Docket No. FDA–2013–N–0403]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Protection of
Human Subjects; Informed Consent;
and Institutional Review Boards
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a proposed collection of
information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995.
DATES: Fax written comments on the
collection of information by January 21,
2020.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0130. Also
include the FDA docket number found
in brackets in the heading of this
document.
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SUMMARY:
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Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
This information collection supports
Agency regulations pertaining to the
protection of human subjects, informed
consent, and responsibilities of
Institutional Review Boards (IRBs) as set
forth in parts 50 and 56 (21 CFR parts
50 and 56). Parts 50 and 56 apply to all
clinical investigations regulated by FDA
under sections 505(i) and 520(g) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(i) and
360j(g), respectively), as well as clinical
investigations that support applications
for research or marketing permits for
products regulated by FDA. The
regulations in parts 50 and 56 are
intended to protect the rights and safety
of subjects involved in such
investigations. The regulations also
contain the standards for composition,
operation, and responsibilities of IRBs
that review clinical investigations
regulated by FDA.
21 CFR Part 50—Protection of Human
Subjects
Provisions in 21 CFR part 50 provide
for the protection of human subjects
involved in FDA-regulated clinical
investigations. With few exceptions, no
investigator may involve a human being
as a subject in FDA-regulated research
unless the investigator has obtained the
legally effective informed consent of the
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subject or the subject’s legally
authorized representative.
Basic elements of informed consent
are set forth in § 50.25 and include,
among other things, a statement of the
purpose and duration of a subject’s
participation in the research; a
description of the procedures to be
followed; identification of any
experimental procedures; a description
of risks, benefits, and appropriate
alternative procedures or treatments; a
description of extent to which
confidentiality of records identifying the
subject will be maintained; certain
contact information; and a statement
that participation is voluntary and may
be discontinued at any time. Additional
elements set forth in § 50.25 are
required in the informed consent as
appropriate. Exceptions to these
requirements are governed by § 50.23,
which requires both investigator and
physician to certify in writing that
necessary elements for exception from
general requirements have been
satisfied; and § 50.24, which covers
exception from informed consent
requirements for emergency research. In
accordance with § 50.27, informed
consent must be documented, except as
provided in § 56.109(c), which provides
for an IRB to waive documentation of
informed consent in certain
circumstances. Informed consent must
be documented using a written consent
form approved by the IRB and signed
and dated by the subject or the subject’s
legally authorized representative at the
time of consent. For each clinical
investigation reviewed by an IRB, we
believe there will typically be one
associated written consent form
developed by an investigator. In some
cases, investigators will seek IRB
approval of changes in the research and/
or consent form after initial IRB
approval. For some multi-institutional
clinical investigations, the IRB of each
institution involved may separately
conduct initial and continuing review of
the research, including review of the
written consent form to determine
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]]>Agencies
[Federal Register Volume 84, Number 244 (Thursday, December 19, 2019)]
[Notices]
[Pages 69746-69747]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27423]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; OCSE-75 Tribal Child Support
Enforcement Program Annual Data Report (OMB #0970-0320)
AGENCY: Office of Child Support Enforcement, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office of Child Support Enforcement (OCSE), Administration
for Children and Families (ACF), U.S. Department of Health and Human
Services (HHS), is requesting a three-year extension of the form OCSE-
75--Tribal Child Support Enforcement Annual Data Report (OMB # 0970-
0320, expiration 03/31/2020). There are no changes requested to the
form.
DATES: Comments due within 30 days of publication. 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.
ADDRESSES: 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:
[email protected]. Attn: Desk Officer for the Administration
for Children and Families.
Copies of the proposed collection may be obtained by emailing
[email protected]. Alternatively, copies can also 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, emailed or
written, should be identified by the title of the information
collection.
SUPPLEMENTARY INFORMATION:
[[Page 69747]]
Description: The data collected by form OCSE-75 are used to prepare
the OCSE preliminary and annual data reports. In addition, Tribes
administering CSE programs under Title IV-D of the Social Security Act
are required to report program status and accomplishments in an annual
narrative report and submit the OCSE-75 report annually.
Respondents: Tribal Child Support Enforcement Organizations or the
Department/Agency/Bureau responsible for Child Support Enforcement in
each tribe.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Average burden
Instrument Annual number of responses hours per Annual burden
of respondents per respondent response hours
----------------------------------------------------------------------------------------------------------------
OCSE-75..................................... 60 1 60 3,600
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 3,600.
Authority: Title IV-D of the Social Security ACT as required by
CFR 45 Section 309.170(b).
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-27423 Filed 12-18-19; 8:45 am]
BILLING CODE 4184-41-P
