Agency Information Collection Activities: Proposed Collection: Public Comment Request, 10358-10359 [2023-03388]
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Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
section 564 of the FD&C Act (88 FR
8874). Termination of the February 6,
2015, declaration automatically
terminated the CDC EV–D68 EUA,
which was the only EUA issued under
the declaration.
III. Electronic Access
An electronic version of this
document is available on the internet at
https://www.regulations.gov.
IV. Notice of EUA Termination
Based on the Secretary of HHS’s
February 6, 2023, termination of the
February 6, 2015, declaration that
circumstances exist justifying the
authorization of emergency use of new
in vitro diagnostics for detection of EV–
D68, FDA is issuing, under section
564(h)(1) of the FD&C Act, this notice of
termination of the May 12, 2015, CDC
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authorization under section 564 of the
FD&C Act, and an explanation of the
reasons therefor.
Dated: February 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–03373 Filed 2–16–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request
Information Collection Request Title:
Healthy Start Evaluation and Quality
Improvement, OMB No. 0915–0338—
Revision.
AGENCY: Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30-day
comment period for this notice has
closed.
lotter on DSK11XQN23PROD with NOTICES1
SUMMARY:
VerDate Sep<11>2014
17:13 Feb 16, 2023
Jkt 259001
Comments on this ICR should be
received no later than March 20, 2023.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email
Samantha Miller, the HRSA Information
Collection Clearance Officer, at
paperwork@hrsa.gov or call 301–594–
4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Healthy Start Evaluation and Quality
Improvement OMB No. 0915–0338—
Revision.
Abstract: The National Healthy Start
Program, authorized by 42 U.S.C. 254c–
8 (section 330H of the Public Health
Service Act), and funded through
HRSA, has the goal to improve health
outcomes before, during, and after
pregnancy, and reduce racial/ethnic
differences in rates of infant death and
adverse perinatal outcomes. The
program began as a demonstration
project with 15 grantees in 1991 and has
expanded since then to 101 grantees
across 35 states; Puerto Rico; and
Washington, DC. Healthy Start grantees
operate in communities with rates of
infant mortality at least 1.5 times the
U.S. national average and high rates for
other adverse perinatal outcomes. These
communities are often low-income and
located in geographically, racially,
ethnically, and linguistically diverse
areas. Healthy Start offers services
during the perinatal period (before,
during, after pregnancy) and the
program works with women, men, and
infants/children through the first 18
months after birth. The Healthy Start
program pursues four goals: (1) improve
women’s health, (2) improve family
health and wellness, (3) promote
systems change, and (4) assure impact
and effectiveness. Over the past few
years, HRSA has sought to implement a
uniform set of data elements for
monitoring and conducting an
evaluation to assess grantees’ progress
towards these program goals. Under the
current OMB approval, the data
collection instruments for the program’s
reporting requirements include three
DATES:
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Fmt 4703
Sfmt 4703
participant-level screening tools: (1)
Background, (2) Prenatal, and (3)
Parenting Information.
In this proposed revision, HRSA plans
to retain the participant-level tools as
approved by OMB in 2020; however,
HRSA did introduce minor changes to
the forms. These changes included only
the following: correction of typos,
addition of response options (e.g.,
‘‘don’t know,’’ ‘‘declined to answer’’),
and clarification of instructions. The
purpose of these minor changes is to
improve the quality of the instruments
and make it easier for the respondents
to complete the forms. The improved
instructions should reduce confusion in
completing the forms. Adding
additional response options will
eliminate forced responses that do not
represent the participant’s intent and
will increase response accuracy.
A 60-day notice published in the
Federal Register, Vol. 87, No. 203, FR
64065–64066 (Friday, October 21, 2022).
There were no public comments.
Need and Proposed Use of the
Information: The purpose of the revised
data collection instruments will be to
assess grantee and participant-level
progress towards meeting Healthy Start
program performance measures. The
data will be used to conduct ongoing
performance monitoring of the program,
thus meeting program needs for
accountability, programmatic decisionmaking, and ongoing quality assurance.
Likely Respondents: For the General
Background, Prenatal, and Parenting
Information participant-level forms,
respondents include pregnant women,
women of reproductive age, and men
who are served by the Healthy Start
program.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose, or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel to be able to respond to a
collection of information; to search data
sources; to complete and review the
collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
Total Estimated Annualized Burden
Hours:
E:\FR\FM\17FEN1.SGM
17FEN1
10359
Federal Register / Vol. 88, No. 33 / Friday, February 17, 2023 / Notices
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total
burden
hours
General Background Form ..................................................
Prenatal ................................................................................
Parenting ..............................................................................
* 45,700
* 30,300
* 30,300
1
1
1
45,700
30,300
30,300
.30
.10
.25
13,710
3,030
7,575
Total ..............................................................................
106,300
........................
106,300
........................
24,315
* All adult participants (45,700) complete the General Background form, and a subset of these same individuals (30,300) also complete the
Prenatal or Parenting forms for total of 106,300 responses.
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality and utility of the information
to be collected, and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–03388 Filed 2–16–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Indian Health Service
The Special Diabetes Program for
Indians Nashville Area Technical
Assistance and Support Program
Announcement Type: New Single
Source.
Funding Announcement Number:
HHS–2023–IHS–SDPI–0002.
Assistance Listing (Catalog of Federal
Domestic Assistance or CFDA) Number:
93.237.
Key Dates
Application Deadline Date: April 3,
2023.
Earliest Anticipated Start Date: April
18, 2023.
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I. Funding Opportunity Description
Statutory Authority
The Indian Health Service (IHS) is
accepting an application for a single
source cooperative agreement with
United South and Eastern Tribes, Inc.
(USET) to continue the Special Diabetes
Program for Indians (SDPI) Nashville
Area technical assistance and support.
These services are authorized under the
Snyder Act, 25 U.S.C. 13; the Transfer
Act, 42 U.S.C. 2001(a); and Section
330C of the Public Health Service Act,
codified at 42 U.S.C. 254c–3. This
program is described in the Assistance
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17:13 Feb 16, 2023
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Listings located at https://sam.gov/
content/home/ (formerly known as the
CFDA) under 93.237.
Background
Diabetes is a complex and costly
chronic disease that requires
tremendous long-term efforts to prevent
and treat. Although diabetes is a
nationwide public health problem,
American Indian and Alaska Native (AI/
AN) people are disproportionately
affected. In 2019, 14.5 percent of AI/AN
people aged 18 years or older had
diagnosed diabetes, compared to 7.4
percent of non-Hispanic white people
[CDC, 2021. https://www.cdc.gov/
diabetes/data/statistics-report/
diagnosed-diabetes.html]. In addition,
AI/AN people have higher rates of
diabetes-related morbidity and mortality
than the general U.S. population
[O’Connell, 2010 (https://
diabetesjournals.org/care/article/33/7/
1463/39326/Racial-Disparities-inHealth-StatusA-comparison-of); Cho,
2014 (https://ajph.
aphapublications.org/doi/full/10.2105/
AJPH.2014.301968)]. Strategies to
address the prevention and treatment of
diabetes in AI/AN communities are
urgently needed.
In response to the burgeoning diabetes
epidemic among AI/AN people,
Congress established the SDPI through
the Balanced Budget Act of 1997. This
grant program was developed to provide
diabetes treatment and/or prevention
activities and/or services (also referred
to as ‘‘activities/services’’) for AI/AN
communities. There are currently 302
SDPI grant programs that are dispersed
throughout each of the 12 IHS Areas.
Each of the IHS Areas contain SDPI
programs (primary grantees or
subgrantees) that implement the
mandatory requirements of the grant
management process, including, but not
limited to, the grant application,
budgetary requirements, data collection/
analysis, reporting, training, etc. Of the
12 IHS Areas, 9 of them have elected to
fund a mechanism to provide technical
support for their SDPI programs within
their Area. Since the inception of SDPI,
the Nashville Area, IHS, has received
PO 00000
Frm 00079
Fmt 4703
Sfmt 4703
technical assistance and SDPI program
support from USET via an SDPI grant
mechanism. It has been determined that
in 2023, support for the Nashville Area
SDPI programs would need to be
supported by USET via an IHS
cooperative agreement.
Purpose
The purpose of this program is to
allow USET to continue to provide
technical assistance and SDPI program
support for the SDPI grant programs in
the Nashville Area. The focus of this
assistance and support would be in the
areas of grant management, program
capacity building, budget development,
and grant reporting to ensure the
Nashville Area SDPI programs are
meeting all of the grant requirements
and deliverables in a timely manner. To
do this, USET must meet the following
objectives:
• Provide culturally-appropriate
training and technical assistance to
Nashville SDPI programs using diabetesspecific tools, the Resource and Patient
Management System (RPMS), and other
electronic health record (EHR) systems.
• Continue to refine and provide
practical and innovative diabetes project
tools.
• Build partnerships and
collaboration for the expansion of
resources and services to Tribal diabetes
programs.
• Demonstrate and provide culturally
appropriate training to Tribal programs
on various Best Practices and topics,
such as tobacco cessation, nutrition,
physical activity, eye exams,
motivational interviewing, Healthy
Heart and Diabetes Prevention Program
curricula, traditional foods/gardens, and
motivational interviewing.
Required, Optional, and Allowable
Activities
(1) Complete a needs assessment
survey to help plan program activities
and prioritize site visits throughout the
Nashville Area, IHS.
(2) The project contracts diabetes
program coordinators to offer technical
assistance and training and discuss the
site’s needs.
E:\FR\FM\17FEN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 33 (Friday, February 17, 2023)]
[Notices]
[Pages 10358-10359]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-03388]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request
Information Collection Request Title: Healthy Start Evaluation and
Quality Improvement, OMB No. 0915-0338--Revision.
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA submitted an Information Collection Request (ICR) to the Office of
Management and Budget (OMB) for review and approval. Comments submitted
during the first public review of this ICR will be provided to OMB. OMB
will accept further comments from the public during the review and
approval period. OMB may act on HRSA's ICR only after the 30-day
comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than March 20,
2023.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Samantha Miller, the HRSA
Information Collection Clearance Officer, at [email protected] or call
301-594-4394.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: Healthy Start Evaluation and
Quality Improvement OMB No. 0915-0338--Revision.
Abstract: The National Healthy Start Program, authorized by 42
U.S.C. 254c-8 (section 330H of the Public Health Service Act), and
funded through HRSA, has the goal to improve health outcomes before,
during, and after pregnancy, and reduce racial/ethnic differences in
rates of infant death and adverse perinatal outcomes. The program began
as a demonstration project with 15 grantees in 1991 and has expanded
since then to 101 grantees across 35 states; Puerto Rico; and
Washington, DC. Healthy Start grantees operate in communities with
rates of infant mortality at least 1.5 times the U.S. national average
and high rates for other adverse perinatal outcomes. These communities
are often low-income and located in geographically, racially,
ethnically, and linguistically diverse areas. Healthy Start offers
services during the perinatal period (before, during, after pregnancy)
and the program works with women, men, and infants/children through the
first 18 months after birth. The Healthy Start program pursues four
goals: (1) improve women's health, (2) improve family health and
wellness, (3) promote systems change, and (4) assure impact and
effectiveness. Over the past few years, HRSA has sought to implement a
uniform set of data elements for monitoring and conducting an
evaluation to assess grantees' progress towards these program goals.
Under the current OMB approval, the data collection instruments for the
program's reporting requirements include three participant-level
screening tools: (1) Background, (2) Prenatal, and (3) Parenting
Information.
In this proposed revision, HRSA plans to retain the participant-
level tools as approved by OMB in 2020; however, HRSA did introduce
minor changes to the forms. These changes included only the following:
correction of typos, addition of response options (e.g., ``don't
know,'' ``declined to answer''), and clarification of instructions. The
purpose of these minor changes is to improve the quality of the
instruments and make it easier for the respondents to complete the
forms. The improved instructions should reduce confusion in completing
the forms. Adding additional response options will eliminate forced
responses that do not represent the participant's intent and will
increase response accuracy.
A 60-day notice published in the Federal Register, Vol. 87, No.
203, FR 64065-64066 (Friday, October 21, 2022). There were no public
comments.
Need and Proposed Use of the Information: The purpose of the
revised data collection instruments will be to assess grantee and
participant-level progress towards meeting Healthy Start program
performance measures. The data will be used to conduct ongoing
performance monitoring of the program, thus meeting program needs for
accountability, programmatic decision-making, and ongoing quality
assurance.
Likely Respondents: For the General Background, Prenatal, and
Parenting Information participant-level forms, respondents include
pregnant women, women of reproductive age, and men who are served by
the Healthy Start program.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose, or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel to be able to respond to a
collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden Hours:
[[Page 10359]]
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
General Background Form......... * 45,700 1 45,700 .30 13,710
Prenatal........................ * 30,300 1 30,300 .10 3,030
Parenting....................... * 30,300 1 30,300 .25 7,575
-------------------------------------------------------------------------------
Total....................... 106,300 .............. 106,300 .............. 24,315
----------------------------------------------------------------------------------------------------------------
* All adult participants (45,700) complete the General Background form, and a subset of these same individuals
(30,300) also complete the Prenatal or Parenting forms for total of 106,300 responses.
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality and utility of the
information to be collected, and (4) the use of automated collection
techniques or other forms of information technology to minimize the
information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-03388 Filed 2-16-23; 8:45 am]
BILLING CODE 4165-15-P
