Proposed Information Collection Activity; Tribal Maternal, Infant, and Early Childhood Home Visiting Program Form 2: Grantee Performance Measures (OMB #0970-0500), 62533-62534 [2019-24797]
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Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices
approval to conduct a new information
collection entitled Evaluation of the
DP18–1801 Healthy Schools Program.
The DP18–1801 Healthy Schools
Program builds upon previous CDC
efforts designed to enhance the capacity
of state education agencies (SEAs) to
adopt and implement evidence-based
policies, practices, and programs that
support health among the nation’s
youth. The purpose of the DP18–1801
Healthy Schools Program is to: (1)
Increase the number of students who
consume nutritious food and beverages
(i.e., those aligned with the Dietary
Guidelines for Americans); (2) increase
the number of students who participate
in daily physical education and
physical activity; and (3) increase the
number of students who can effectively
manage their chronic health conditions.
The evaluation approach is a multisite,
embedded case study design, consisting
of both process and outcome
components, focusing on three 1801
state grantees and a subset of their
targeted LEAs and schools. The process
component will assess implementation
of strategies and activities at the state,
local, and school levels and their
integration across levels; fidelity of
implementation; implementation
facilitators and barriers; and
contributions of national and state level
TA towards program achievements.
Three primary data collection methods
will be used: (1) Key informant
interviews (KII) conducted during inperson site visits or by phone, (2) Webbased surveys, and (3) review of
secondary data sources. CDC is
requesting approval for an estimated
265 annual burden hours.
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Type of respondents
Form name
SEA staff .........................................................
Web-Survey ....................................................
Key-Informant Interview .................................
Web-Survey ....................................................
Key-Informant Interview .................................
Web-Survey ....................................................
Key-Informant Interview .................................
LEA staff .........................................................
School staff .....................................................
Jeffrey M. Zirger,
Lead, Information Collection Review Office,
Office of Scientific Integrity, Office of Science,
Centers for Disease Control and Prevention.
[FR Doc. 2019–24728 Filed 11–14–19; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
Proposed Information Collection
Activity; Tribal Maternal, Infant, and
Early Childhood Home Visiting
Program Form 2: Grantee Performance
Measures (OMB #0970–0500)
Office of Child Care;
Administration for Children and
Families; HHS.
ACTION: Request for public comment.
AGENCY:
The Administration for
Children and Families (ACF) is
requesting a 3-year extension of the
ACF-Tribal Maternal, Infant, and Early
Childhood Home Visiting (Tribal
MIECHV) Program Form 2: Grantee
Performance Measures (OMB #0970–
0500; Expiration date 8/31/2020). There
are no changes requested to the form.
DATES: Comments due within 60 days of
publication. In compliance with the
requirements of Section 3506(c)(2)(A) of
the Paperwork Reduction Act of 1995,
the Administration for Children and
Families is soliciting public comment
SUMMARY:
VerDate Sep<11>2014
16:58 Nov 14, 2019
Jkt 250001
on the specific aspects of the
information collection described above.
ADDRESSES: Copies of the proposed
collection of information can be
obtained and comments may be
forwarded 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 (OPRE), 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:
Description: The Maternal, Infant, and
Early Childhood Home Visiting Program
(MIECHV) authorizes the Secretary of
HHS (in Section 511(h)(2)(A)) to award
grants to Indian tribes (or a consortium
of Indian tribes), tribal organizations, or
urban Indian organizations to conduct
an early childhood home visiting
program. The legislation set aside 3
percent of the total MIECHV program
appropriation for grants to tribal
entities. Tribal MIECHV grants, to the
greatest extent practicable, are to be
consistent with the requirements of the
MIECHV grants to states and
jurisdictions and include conducting a
needs assessment and establishing
quantifiable, measurable benchmarks.
The ACF, Office of Child Care, in
collaboration with the Health Resources
and Services Administration, Maternal
and Child Health Bureau, awards grants
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Frm 00032
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
3
9
30
12
210
54
1
1
1
1
1
1
Average
burden per
response
(in hours)
75/60
75/60
75/60
75/60
75/60
75/60
for the Tribal MIECHV Program. The
Tribal MIECHV grant awards support 5year cooperative agreements to conduct
community needs assessments; plan for
and implement high-quality, culturally
relevant, evidence-based home visiting
programs in at-risk tribal communities;
collect and report on performance
measures; and participate in research
and evaluation activities to build the
knowledge base on home visiting among
Native populations.
Specifically, the MIECHV legislation
requires that State and Tribal MIECHV
grantees collect performance data to
measure improvements for eligible
families in six specified areas (referred
to as ‘‘benchmark areas’’) that
encompass the major goals for the
program. These include:
1. Improved maternal and newborn
health;
2. Prevention of child injuries, child
abuse, neglect, or maltreatment, and
reduction in emergency department
visits;
3. Improvement in school readiness
and achievement;
4. Reduction in crime or domestic
violence;
5. Improvement in family economic
self-sufficiency; and
6. Improvement in the coordination
and referrals for other community
resources and supports.
Tribal MIECHV grantees are required
to propose a plan for meeting the
benchmark requirements specified in
the legislation and must report on
E:\FR\FM\15NON1.SGM
15NON1
62534
Federal Register / Vol. 84, No. 221 / Friday, November 15, 2019 / Notices
improvement on constructs under each
benchmark area. The Tribal Home
Visiting (HV) Form 2 provides a
template for Tribal MIECHV grantees to
report data on their progress in
improving performance under the six
benchmark areas, as stipulated in the
legislation.
ACF will continue to use Tribal HV
Form 2 to:
• Track and improve the quality of
benchmark measures data submitted by
the Tribal grantees;
• Improve program monitoring and
oversight;
• Improve rigorous data analyses that
help to assess the effectiveness of the
programs and enable ACF to better
monitor projects; and
• Ensure adequate and timely
reporting of program data to relevant
federal agencies and stakeholders
including Congress and members of the
public.
Respondents: Tribal MIECHV Program
Grantees.
ANNUAL BURDEN ESTIMATES
Instrument
Total
number of
respondents
Annual
number of
responses per
respondent
Average
burden hours
per response
Annual
burden hours
Tribal MIECHV Form 2 ....................................................................................
25
1
500
12,500
Estimated Total Annual Burden
Hours: 12,500.
Comments: 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.
Authority: Public Law 115–123,
Section 511(h)(2)(A) of Title V of the
Social Security Act.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019–24797 Filed 11–14–19; 8:45 am]
BILLING CODE 4184–77–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2544]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Medical Devices;
Current Good Manufacturing Practice
Quality System Regulation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
SUMMARY:
VerDate Sep<11>2014
16:58 Nov 14, 2019
Jkt 250001
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
(PRA).
DATES: Fax written comments on the
collection of information by December
16, 2019.
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 0910–0073. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT:
Amber Sanford, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–8867, PRAStaff@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
Medical Devices: Current Good
Manufacturing Practice Quality System
Regulation—21 CFR Part 820
OMB Control Number 0910–0073—
Extension
Under section 520(f) of the Federal
Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360j(f)), the Secretary of
the Department of Health and Human
Services has the authority to prescribe
regulations requiring that the methods
used in, and the facilities and controls
used for, the manufacture,
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preproduction design validation
(including a process to assess the
performance of a device, but not
including an evaluation of the safety
and effectiveness of a device), packing,
storage, and installation of a device
conform to current good manufacturing
practice (CGMP), as described in such
regulations, to assure that the device
will be safe and effective and otherwise
in compliance with the FD&C Act.
The CGMP quality system (QS)
regulation implementing authority
provided by this statutory provision is
found under part 820 (21 CFR part 820)
and sets forth basic CGMP requirements
governing the design, manufacture,
packing, labeling, storage, installation,
and servicing of all finished medical
devices intended for human use. The
authority for this regulation is covered
under sections 501, 502, 510, 513, 514,
515, 518, 519, 520, 522, 701, 704, 801,
and 803 of the FD&C Act (21 U.S.C. 351,
352, 360, 360c, 360d, 360e, 360h, 360i,
360j, 360l, 371, 374, 381, and 383). The
CGMP/QS regulation includes
requirements for purchasing and service
controls, clarifies recordkeeping
requirements for device failure and
complaint investigations, clarifies
requirements for verifying/validating
production processes and process or
product changes, and clarifies
requirements for product acceptance
activities, quality data evaluations, and
corrections of nonconforming product/
quality problems.
Requirements are compatible with
specifications in the international
standards ‘‘ISO 9001: Quality Systems
Model for Quality Assurance in Design/
Development, Production, Installation,
and Servicing.’’ The CGMP/QS
information collections will assist FDA
inspections of manufacturers for
compliance with QS requirements
encompassing design, production,
installation, and servicing processes.
E:\FR\FM\15NON1.SGM
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]]>Agencies
[Federal Register Volume 84, Number 221 (Friday, November 15, 2019)]
[Notices]
[Pages 62533-62534]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24797]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Administration for Children and Families
Proposed Information Collection Activity; Tribal Maternal,
Infant, and Early Childhood Home Visiting Program Form 2: Grantee
Performance Measures (OMB #0970-0500)
AGENCY: Office of Child Care; Administration for Children and Families;
HHS.
ACTION: Request for public comment.
-----------------------------------------------------------------------
SUMMARY: The Administration for Children and Families (ACF) is
requesting a 3-year extension of the ACF-Tribal Maternal, Infant, and
Early Childhood Home Visiting (Tribal MIECHV) Program Form 2: Grantee
Performance Measures (OMB #0970-0500; Expiration date 8/31/2020). There
are no changes requested to the form.
DATES: Comments due within 60 days of publication. In compliance with
the requirements of Section 3506(c)(2)(A) of the Paperwork Reduction
Act of 1995, the Administration for Children and Families is soliciting
public comment on the specific aspects of the information collection
described above.
ADDRESSES: Copies of the proposed collection of information can be
obtained and comments may be forwarded 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 (OPRE), 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:
Description: The Maternal, Infant, and Early Childhood Home
Visiting Program (MIECHV) authorizes the Secretary of HHS (in Section
511(h)(2)(A)) to award grants to Indian tribes (or a consortium of
Indian tribes), tribal organizations, or urban Indian organizations to
conduct an early childhood home visiting program. The legislation set
aside 3 percent of the total MIECHV program appropriation for grants to
tribal entities. Tribal MIECHV grants, to the greatest extent
practicable, are to be consistent with the requirements of the MIECHV
grants to states and jurisdictions and include conducting a needs
assessment and establishing quantifiable, measurable benchmarks.
The ACF, Office of Child Care, in collaboration with the Health
Resources and Services Administration, Maternal and Child Health
Bureau, awards grants for the Tribal MIECHV Program. The Tribal MIECHV
grant awards support 5-year cooperative agreements to conduct community
needs assessments; plan for and implement high-quality, culturally
relevant, evidence-based home visiting programs in at-risk tribal
communities; collect and report on performance measures; and
participate in research and evaluation activities to build the
knowledge base on home visiting among Native populations.
Specifically, the MIECHV legislation requires that State and Tribal
MIECHV grantees collect performance data to measure improvements for
eligible families in six specified areas (referred to as ``benchmark
areas'') that encompass the major goals for the program. These include:
1. Improved maternal and newborn health;
2. Prevention of child injuries, child abuse, neglect, or
maltreatment, and reduction in emergency department visits;
3. Improvement in school readiness and achievement;
4. Reduction in crime or domestic violence;
5. Improvement in family economic self-sufficiency; and
6. Improvement in the coordination and referrals for other
community resources and supports.
Tribal MIECHV grantees are required to propose a plan for meeting
the benchmark requirements specified in the legislation and must report
on
[[Page 62534]]
improvement on constructs under each benchmark area. The Tribal Home
Visiting (HV) Form 2 provides a template for Tribal MIECHV grantees to
report data on their progress in improving performance under the six
benchmark areas, as stipulated in the legislation.
ACF will continue to use Tribal HV Form 2 to:
Track and improve the quality of benchmark measures data
submitted by the Tribal grantees;
Improve program monitoring and oversight;
Improve rigorous data analyses that help to assess the
effectiveness of the programs and enable ACF to better monitor
projects; and
Ensure adequate and timely reporting of program data to
relevant federal agencies and stakeholders including Congress and
members of the public.
Respondents: Tribal MIECHV Program Grantees.
Annual Burden Estimates
----------------------------------------------------------------------------------------------------------------
Annual number Average burden
Instrument Total number of responses hours per Annual burden
of respondents per respondent response hours
----------------------------------------------------------------------------------------------------------------
Tribal MIECHV Form 2........................ 25 1 500 12,500
----------------------------------------------------------------------------------------------------------------
Estimated Total Annual Burden Hours: 12,500.
Comments: 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.
Authority: Public Law 115-123, Section 511(h)(2)(A) of Title V of
the Social Security Act.
Mary B. Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2019-24797 Filed 11-14-19; 8:45 am]
BILLING CODE 4184-77-P
