Submission for OMB Review; Formative Data Collections for ACF Program Support (New Collection), 28307-28308 [2019-12801]
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Federal Register / Vol. 84, No. 117 / Tuesday, June 18, 2019 / Notices
Washington, DC 20201, Attn: OPRE
Reports Clearance Officer. All requests
should be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
SUPPLEMENTARY INFORMATION:
Description: The Head Start Directors
Wave 1 survey addresses the grantee’s
organizational characteristics, how the
organization defines and diffuses T/TA,
T/TA received and requested in the
prior program year, and overall
organizational goals and reflections on
T/TA efforts for the current year. The
Head Start Managers/Coordinators Wave
2 survey addresses four distinct
domains of Head Start activity: (1)
Program management and fiscal
operations; (2) education; (3) parent and
family engagement; and (4) health and
wellness. The Wave 2 survey addresses
how these activity domains are
structured and staffed with the grantee
organization, the types of T/TA and
resources sought and used to improve
practice in each domain, perceptions of
usefulness of recent T/TA received, and
T/TA priorities for the next program
year.
Respondents: Head Start Directors,
Head Start Managers/Coordinators.
ANNUAL BURDEN ESTIMATES
Total/annual
number of
respondents
Instrument
Wave 1 Head Start Director Survey ................................................................
Wave 2 Head Start Managers/Coordinator Survey .........................................
Estimated Total Annual Burden
Hours: 1,544.
Authority: The Statutory Authority for
this data collection is: Section
640(a)(2)(D) and section 649 of the
Improving Head Start for School
Readiness Act of 2007.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–12783 Filed 6–17–19; 8:45 am]
BILLING CODE 4184–40–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Submission for OMB Review;
Formative Data Collections for ACF
Program Support (New Collection)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, HHS.
ACTION: Request for public comment.
jbell on DSK3GLQ082PROD with NOTICES
AGENCY:
SUMMARY: The Office of Planning,
Research, and Evaluation (OPRE), in the
Administration for Children and
Families (ACF) at the U.S. Department
of Health and Human Services (HHS)
intends to request approval from the
Office of Management and Budget
(OMB) for a generic clearance to
conduct a variety of formative data
collections with more than nine
respondents. These information
collections would not be highly
systematic or intended to be statistically
representative or otherwise
generalizable. ACF programs promote
the economic and social well-being of
families, children, individuals and
communities. Many ACF program
offices need to learn more about funded
program services so that an
understanding of program or grantee
VerDate Sep<11>2014
18:40 Jun 17, 2019
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1,200
860
processes and potential for
improvements can inform ACF
decision-making and program support.
Information collected under this generic
would help address these needs.
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
OPREinfocollection@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: OPRE
Reports Clearance Officer. All requests,
emailed or written, should be identified
by the title of the information collection.
SUPPLEMENTARY INFORMATION:
Description: Information gathering for
program support was originally
described under the Formative Data
Collections for ACF Research Generic
Clearance (0970–0356), but is now being
requested as a stand-alone generic
clearance. A 60-day comment period
was provided as part of the approval
process for #0970–0356, which included
description of information collections
for program support. We are now
providing a 30-day comment period
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Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
Average
burden
hours per
response
.75
.75
Annual
burden
hours
900
644
specific to this generic clearance for
program support.
The goals of the generic information
collections under this approval are to
obtain information about program and
grantee processes or needs, and to
inform the following types of activities,
among others:
• Delivery of targeted assistance and
workflows related to program
implementation or the development or
refinement of program and grantee
processes, and the development and
refinement of recordkeeping and
communication systems.
• Planning for provision of
programmatic or evaluation-related
training or technical assistance (T/TA).
• Obtaining grantee or other
stakeholder input on the development
of program performance measures.
• Use of rapid-cycle testing activities
to strengthen programs in preparation
for summative evaluation.
• Development of learning agendas
and research priorities.
ACF envisions using a variety of
techniques such as semi-structured
discussions, focus groups, surveys,
templates, open-ended requests, and
telephone or in-person interviews, in
order to reach these goals.
Following standard OMB
requirements, OPRE will submit a
change request for each individual data
collection activity under this generic
clearance. Each request will include the
individual instrument(s), a justification
specific to the individual information
collection, and any supplementary
documents. OMB should review
requests within 10 days of submission.
Respondents: Example respondents
include: current or prospective service
providers, training or technical
assistance (T/TA) providers, grantees,
contractors, current and potential
participants in ACF programs or similar
comparison groups, experts in fields
E:\FR\FM\18JNN1.SGM
18JNN1
28308
Federal Register / Vol. 84, No. 117 / Tuesday, June 18, 2019 / Notices
pertaining to ACF programs, key
stakeholder groups involved in ACF
projects and programs, individuals
engaged in program re-design or
demonstration development for
evaluation, state or local government
officials, or others involved in or
prospectively involved in ACF
programs.
ANNUAL BURDEN ESTIMATES
Estimated
number of
responses
per
respondent
Estimated
total number
of
respondents
Instrument type
Average
burden hours
per response
Estimated
total burden
hours
Semi-Structured Discussions and Focus Groups ............................................
Interviews .........................................................................................................
Questionnaires/Surveys ...................................................................................
Templates and Open-ended requests .............................................................
2,000
1,000
1,000
250
1
1
* 1.5
1
2
1
.5
10
4,000
1,000
750
2,500
Total ..........................................................................................................
........................
........................
........................
8,250
* We have estimated 1.5 responses to account for rapid cycle testing, which will require multiple responses.
Authority: Social Security Act, Sec. 1110.
[42 U.S.C. 1310].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–12801 Filed 6–17–19; 8:45 am]
BILLING CODE 4184–79–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection:
Comment Request Information
Request Title: 340B Drug Pricing
Program Reporting Requirements,
OMB Number 0915–0176—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
jbell on DSK3GLQ082PROD with NOTICES
AGENCY:
SUMMARY: In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an Information Collection
Request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
OMB, HRSA seeks comments from the
public regarding the burden estimate or
any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than August 19, 2019.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
VerDate Sep<11>2014
17:23 Jun 17, 2019
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instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance
Officer, at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Drug Pricing Program Reporting
Requirements OMB No. 0915–0176—
[Extension].
Abstract: Section 340B of the Public
Health Service Act (PHS Act
‘‘Limitation on Prices of Drugs
Purchased by Covered Entities’’)
instructs HHS to enter into a
Pharmaceutical Pricing Agreement
(PPA) with manufacturers of covered
outpatient drugs. Manufacturers are
required by section 1927(a)(5)(A) of the
Social Security Act to enter into
agreements with the Secretary of HHS to
comply with section 340B of the PHS
Act if they participate in the Medicaid
Drug Rebate Program. When a drug
manufacturer signs a PPA, it is opting
into the 340B Drug Pricing Program
(340B Program) and it agrees to the
statutory requirement that prices
charged for covered outpatient drugs to
covered entities will not exceed defined
340B ceiling prices, which are based on
quarterly pricing data reported by
manufacturers to the Centers for
Medicare & Medicaid Services (CMS).
When an eligible covered entity
voluntarily decides to enroll and
participate in the 340B Program, it
accepts responsibility for ensuring
compliance with all provisions of the
340B Program, including all associated
costs. Covered entities that choose to
participate in the 340B Program must
comply with the requirements of section
340B(a)(5) of the PHS Act. Section
340B(a)(5)(A) prohibits a covered entity
from accepting a discount for a drug that
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Frm 00043
Fmt 4703
Sfmt 4703
would also generate a Medicaid rebate.
Further, section 340B(a)(5)(B) prohibits
a covered entity from reselling or
otherwise transferring a discounted drug
to a person who is not a patient of the
covered entity.
Section 340B(a)(5)(C) of the PHS Act
permits the Secretary of HHS and
manufacturers of a covered outpatient
drug to conduct audits of covered
entities in accordance with procedures
established by the Secretary related to
the number, duration, and scope of the
audits. Manufacturers are permitted to
conduct an audit only when there is
reasonable cause to believe a violation
of section 340B(a)(5)(A) or (B) has
occurred. The manufacturer notifies the
covered entity in writing when it
believes the covered entity has violated
these provisions of the 340B Program. If
the problem cannot be resolved, the
manufacturer will then submit an audit
work plan describing the audit and
evidence in support of the reasonable
cause standard to the HRSA, Healthcare
Systems Bureau, Office of Pharmacy
Affairs (OPA) for review. OPA will
review the documentation to determine
if reasonable cause exists. Once the
audit is completed, the manufacturer
will submit copies of the audit report to
OPA for review and resolution of the
findings, as appropriate. The
manufacturer will also submit an
informational copy of the audit report to
the HHS Office of Inspector General
(OIG).
In response to the statutory mandate
of section 340B(a)(5)(C) to permit the
Secretary or manufacturers to conduct
audits of covered entities and because of
the potential for disputes involving
covered entities and participating drug
manufacturers, OPA developed an
informal voluntary dispute resolution
process for manufacturers and covered
entities who, prior to filing a request for
resolution of a dispute with OPA,
E:\FR\FM\18JNN1.SGM
18JNN1
]]>Agencies
[Federal Register Volume 84, Number 117 (Tuesday, June 18, 2019)]
[Notices]
[Pages 28307-28308]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-12801]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Submission for OMB Review; Formative Data Collections for ACF
Program Support (New Collection)
AGENCY: Office of Planning, Research, and Evaluation, Administration
for Children and Families, HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Office of Planning, Research, and Evaluation (OPRE), in
the Administration for Children and Families (ACF) at the U.S.
Department of Health and Human Services (HHS) intends to request
approval from the Office of Management and Budget (OMB) for a generic
clearance to conduct a variety of formative data collections with more
than nine respondents. These information collections would not be
highly systematic or intended to be statistically representative or
otherwise generalizable. ACF programs promote the economic and social
well-being of families, children, individuals and communities. Many ACF
program offices need to learn more about funded program services so
that an understanding of program or grantee processes and potential for
improvements can inform ACF decision-making and program support.
Information collected under this generic would help address these
needs.
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: OPRE Reports Clearance Officer. All
requests, emailed or written, should be identified by the title of the
information collection.
SUPPLEMENTARY INFORMATION:
Description: Information gathering for program support was
originally described under the Formative Data Collections for ACF
Research Generic Clearance (0970-0356), but is now being requested as a
stand-alone generic clearance. A 60-day comment period was provided as
part of the approval process for #0970-0356, which included description
of information collections for program support. We are now providing a
30-day comment period specific to this generic clearance for program
support.
The goals of the generic information collections under this
approval are to obtain information about program and grantee processes
or needs, and to inform the following types of activities, among
others:
Delivery of targeted assistance and workflows related to
program implementation or the development or refinement of program and
grantee processes, and the development and refinement of recordkeeping
and communication systems.
Planning for provision of programmatic or evaluation-
related training or technical assistance (T/TA).
Obtaining grantee or other stakeholder input on the
development of program performance measures.
Use of rapid-cycle testing activities to strengthen
programs in preparation for summative evaluation.
Development of learning agendas and research priorities.
ACF envisions using a variety of techniques such as semi-structured
discussions, focus groups, surveys, templates, open-ended requests, and
telephone or in-person interviews, in order to reach these goals.
Following standard OMB requirements, OPRE will submit a change
request for each individual data collection activity under this generic
clearance. Each request will include the individual instrument(s), a
justification specific to the individual information collection, and
any supplementary documents. OMB should review requests within 10 days
of submission.
Respondents: Example respondents include: current or prospective
service providers, training or technical assistance (T/TA) providers,
grantees, contractors, current and potential participants in ACF
programs or similar comparison groups, experts in fields
[[Page 28308]]
pertaining to ACF programs, key stakeholder groups involved in ACF
projects and programs, individuals engaged in program re-design or
demonstration development for evaluation, state or local government
officials, or others involved in or prospectively involved in ACF
programs.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Estimated
Estimated number of Average burden Estimated
Instrument type total number responses per hours per total burden
of respondents respondent response hours
----------------------------------------------------------------------------------------------------------------
Semi-Structured Discussions and Focus Groups.... 2,000 1 2 4,000
Interviews...................................... 1,000 1 1 1,000
Questionnaires/Surveys.......................... 1,000 * 1.5 .5 750
Templates and Open-ended requests............... 250 1 10 2,500
---------------------------------------------------------------
Total....................................... .............. .............. .............. 8,250
----------------------------------------------------------------------------------------------------------------
* We have estimated 1.5 responses to account for rapid cycle testing, which will require multiple responses.
Authority: Social Security Act, Sec. 1110. [42 U.S.C. 1310].
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-12801 Filed 6-17-19; 8:45 am]
BILLING CODE 4184-79-P
