Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Healthy Start Evaluation and Quality Improvement, 62911-62912 [2016-21889]
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Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices
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I. Background
FDA is announcing the availability of
a document entitled ‘‘Use of Nucleic
Acid Tests to Reduce the Risk of
Transmission of West Nile Virus From
Living Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products
(HCT/Ps); Guidance for Industry.’’ The
guidance document provides
establishments that make donor
eligibility determinations for donors of
HCT/Ps with recommendations for
testing living donors for WNV. The
guidance does not provide
recommendations regarding testing of
cadaveric HCT/P donors for WNV. FDA
believes that the use of an FDA-licensed
NAT will reduce the risk of
transmission of WNV from living donors
of HCT/Ps and therefore recommends
that you use an FDA-licensed NAT for
testing living donors of HCT/Ps for
infection with WNV as set forth in the
guidance. The 2007 Donor Eligibility
Guidance indicated that FDA may
recommend routine use of an
appropriate, licensed donor screening
test(s) to detect acute infections with
WNV using NAT technology, once such
tests were available.
In the Federal Register of December
15, 2015 (80 FR 77645), FDA announced
the availability of the draft guidance
entitled ‘‘Use of Nucleic Acid Tests to
Reduce the Risk of Transmission of
West Nile Virus from Living Donors of
Human Cells, Tissues, and Cellular and
Tissue-Based Products (HCT/Ps); Draft
Guidance for Industry’’ dated December
2015 (December 2015 draft guidance).
FDA received several comments on the
draft guidance and those comments
were considered as the guidance was
developed.
In the Federal Register of February
28, 2007 (72 FR 9007), FDA announced
the availability of the 2007 Donor
Eligibility Guidance. FDA issued a
revised version of this guidance under
the same title, dated August 2007 (2007
Donor Eligibility Guidance).
The guidance announced in this
notice finalizes the December 2015 draft
guidance and supplements sections
IV.E. (recommendations 15 and 16) and
IV.F. (recommendation 5), and
supersedes the ‘‘West Nile Virus
(WNV)’’ section in Appendix 6 of the
2007 Donor Eligibility Guidance.
The guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Use of Nucleic
Acid Tests to Reduce the Risk of
Transmission of West Nile Virus from
Living Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products
VerDate Sep<11>2014
15:27 Sep 12, 2016
Jkt 238001
(HCT/Ps).’’ It does not establish any
rights for any person and is not binding
on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
II. Electronic Access
Persons with access to the Internet
may obtain the guidance at either https://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm or
https://www.regulations.gov.
Dated: September 8, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–21969 Filed 9–12–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Healthy Start Evaluation and
Quality Improvement
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, HRSA has
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.
DATES: Comments on this ICR should be
received no later than October 13, 2016.
ADDRESSES: Submit your comments,
including the Information Collection
Request Title, to the desk officer for
HRSA, either by email to OIRA_
submission@omb.eop.gov or by fax to
202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Healthy Start Evaluation and Quality
Improvement OMB No. 0915–0338—
Revision
SUMMARY:
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
62911
Abstract: The National Healthy Start
Program, funded through HRSA’s
Maternal and Child Health Bureau
(MCHB), has the goal of reducing
disparities in infant mortality and
adverse perinatal outcomes. The
program began as a demonstration
project with 15 grantees in 1991 and has
expanded over the past 2 decades to 100
grantees across 37 states 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 geographically,
racially, ethnically, and linguistically
diverse low-income areas. Healthy Start
covers services during the perinatal
period (before, during, after pregnancy)
and follows the woman and infant
through 2 years after the end of the
pregnancy. The Healthy Start program
has five approaches including: (1)
Improving women’s health; (2)
promoting quality services; (3)
strengthening family resilience; (4)
achieving collective impact; and (5)
increasing accountability through
quality assurance, performance
monitoring, and evaluation.
MCHB seeks to implement a uniform
set of data elements for monitoring and
conducting a mixed-methods evaluation
to assess the effectiveness of the
program on individual, organizational,
and community-level outcomes. Data
collection instruments will include a
National Healthy Start Program Survey;
Community Action Network Survey;
Healthy Start Site Visit Protocol;
Healthy Start Participant Focus Group
Protocol—these instruments have not
been changed. The Preconception,
Pregnancy and Parenting (3Ps)
Information Form will also be used as
a data collection instrument; however
the 3Ps Information Form has been
redesigned from one form into six
forms. The six forms include: (1)
Demographic Intake Form; (2)
Pregnancy Status/History; (3)
Preconception; (4) Prenatal; (5)
Postpartum; and (6) Interconception/
Parenting. The purpose of this redesign
is to enhance the 3Ps Information Form
to ensure collected data is meaningful
for monitoring and evaluation, as well
as screening and care coordination, and
streamline previously separate data
systems. The 3Ps Information Form was
also redesigned to allow questions to be
administered in accordance with the
participant’s enrollment/service
delivery status and perinatal period. In
addition to redesigning the 3Ps
Information Form, HRSA deleted
questions that are neither critical for
E:\FR\FM\13SEN1.SGM
13SEN1
62912
Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices
evaluation nor programmatic purposes.
HRSA also added questions to the 3Ps
Information Form to allow the Form to
be used as an all-inclusive data
collection instrument for MCHB and
Healthy Start grantees. The additional
questions extend and refine previously
approved content, allowing for the
collection of more granular and/or indepth information on existing topics.
Adding these questions allows Healthy
Start grantees to better assess risk,
identify needed services, provide
appropriate follow-up activities to
program participants, and improve
overall service delivery and quality.
Need and Proposed Use of the
Information: The purpose of the data
collection instruments is to obtain
consistent information across all
grantees about Healthy Start and its
outcomes. The data will be used to: (1)
Conduct ongoing performance
monitoring of the program; (2) provide
credible and rigorous evidence of
program effect on outcomes; (3) assess
the relative contribution of the five
program approaches to individual and
community-level outcomes; (4) meet
program needs for accountability,
programmatic decision-making, and
ongoing quality assurance; and (5)
strengthen the evidence-base, and
identify best and promising practices for
the program to support sustainability,
replication, and dissemination of the
program.
Likely Respondents: Respondents
include project directors and staff for
the National Healthy Start Program
Survey; representatives from partner
organizations for the Community Action
Network Survey; program staff,
providers, and partners for the Healthy
Start Site Visit Protocol; and program
participants for the Healthy Start
Participant Focus Group Protocol.
Respondents for the redesigned 3Ps
Information Form (i.e., (1) Demographic
Intake; (2) Pregnancy Status/History; (3)
Preconception; (4) Prenatal; (5)
Postpartum; and (6) Interconception/
Parenting) are pregnant women and
women of reproductive age 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 and 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
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
3Ps Information Form:
1. Demographic Intake Form ........................................
2. Pregnancy Status/History .........................................
3. Preconception ...........................................................
4. Prenatal ....................................................................
5. Postpartum ...............................................................
6. Interconception/Parenting .........................................
National Healthy Start Program Web Survey ......................
CAN member Web Survey ..................................................
Healthy Start Site Visit Protocol ..........................................
Healthy Start Participant Focus Group Protocol .................
* + 40,675
40,675
* + 20,337
20,337
20,337
20,337
+ 100
+ 225
+ 15
+ 180
1
1
1
1
1
1
1
1
1
1
40,675
40,675
20,337
20,337
20,337
20,337
100
225
15
180
0.08
0.17
1.00
1.00
1.00
1.00
2.00
0.75
6.00
1.00
3,254
6,915
20,337
20,337
20,337
20,337
200
169
90
180
Total ..............................................................................
61,532
........................
61,532
........................
92,156
* The same individuals (40,675) complete the Demographic Intake and Pregnancy Status/History forms, and a subset of these same individuals
(20,337) also complete the Preconception, Prenatal, Postpartum, and Interconception/Parenting forms for total of 61,532 respondents and responses.
+ These are the numbers included in the total respondent count.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–21889 Filed 9–12–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Lhorne on DSK30JT082PROD with NOTICES
National Institutes of Health
Office of the Director Notice of Charter
Renewal
In accordance with Title 41 of the
U.S. Code of Federal Regulations,
Section 102–3.65(a), notice is hereby
given that the Charter for the Fogarty
International Center Advisory Board
VerDate Sep<11>2014
15:27 Sep 12, 2016
Jkt 238001
was renewed for an additional two-year
period on August 31, 2016.
It is determined that the Fogarty
International Center Advisory Board is
in the public interest in connection with
the performance of duties imposed on
the National Institutes of Health by law,
and that these duties can best be
performed through the advice and
counsel of this group.
Inquiries may be directed to Jennifer
Spaeth, Director, Office of Federal
Advisory Committee Policy, Office of
the Director, National Institutes of
Health, 6701 Democracy Boulevard,
Suite 1000, Bethesda, Maryland 20892
(Mail code 4875), Telephone (301) 496–
2123, or spaethj@od.nih.gov.
PO 00000
Frm 00059
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Dated: September 6, 2016.
Jennifer Spaeth,
Director, Office of Federal Advisory
Committee Policy.
[FR Doc. 2016–21899 Filed 9–12–16; 8:45 am]
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Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
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]]>Agencies
[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)]
[Notices]
[Pages 62911-62912]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21889]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Healthy Start Evaluation
and Quality Improvement
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with section 3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, HRSA has 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.
DATES: Comments on this ICR should be received no later than October
13, 2016.
ADDRESSES: Submit your comments, including the Information Collection
Request Title, to the desk officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by fax to 202-395-5806.
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email the HRSA Information
Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443-
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: Healthy Start Evaluation and
Quality Improvement OMB No. 0915-0338--Revision
Abstract: The National Healthy Start Program, funded through HRSA's
Maternal and Child Health Bureau (MCHB), has the goal of reducing
disparities in infant mortality and adverse perinatal outcomes. The
program began as a demonstration project with 15 grantees in 1991 and
has expanded over the past 2 decades to 100 grantees across 37 states
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 geographically, racially, ethnically, and linguistically diverse
low-income areas. Healthy Start covers services during the perinatal
period (before, during, after pregnancy) and follows the woman and
infant through 2 years after the end of the pregnancy. The Healthy
Start program has five approaches including: (1) Improving women's
health; (2) promoting quality services; (3) strengthening family
resilience; (4) achieving collective impact; and (5) increasing
accountability through quality assurance, performance monitoring, and
evaluation.
MCHB seeks to implement a uniform set of data elements for
monitoring and conducting a mixed-methods evaluation to assess the
effectiveness of the program on individual, organizational, and
community-level outcomes. Data collection instruments will include a
National Healthy Start Program Survey; Community Action Network Survey;
Healthy Start Site Visit Protocol; Healthy Start Participant Focus
Group Protocol--these instruments have not been changed. The
Preconception, Pregnancy and Parenting (3Ps) Information Form will also
be used as a data collection instrument; however the 3Ps Information
Form has been redesigned from one form into six forms. The six forms
include: (1) Demographic Intake Form; (2) Pregnancy Status/History; (3)
Preconception; (4) Prenatal; (5) Postpartum; and (6) Interconception/
Parenting. The purpose of this redesign is to enhance the 3Ps
Information Form to ensure collected data is meaningful for monitoring
and evaluation, as well as screening and care coordination, and
streamline previously separate data systems. The 3Ps Information Form
was also redesigned to allow questions to be administered in accordance
with the participant's enrollment/service delivery status and perinatal
period. In addition to redesigning the 3Ps Information Form, HRSA
deleted questions that are neither critical for
[[Page 62912]]
evaluation nor programmatic purposes. HRSA also added questions to the
3Ps Information Form to allow the Form to be used as an all-inclusive
data collection instrument for MCHB and Healthy Start grantees. The
additional questions extend and refine previously approved content,
allowing for the collection of more granular and/or in-depth
information on existing topics. Adding these questions allows Healthy
Start grantees to better assess risk, identify needed services, provide
appropriate follow-up activities to program participants, and improve
overall service delivery and quality.
Need and Proposed Use of the Information: The purpose of the data
collection instruments is to obtain consistent information across all
grantees about Healthy Start and its outcomes. The data will be used
to: (1) Conduct ongoing performance monitoring of the program; (2)
provide credible and rigorous evidence of program effect on outcomes;
(3) assess the relative contribution of the five program approaches to
individual and community-level outcomes; (4) meet program needs for
accountability, programmatic decision-making, and ongoing quality
assurance; and (5) strengthen the evidence-base, and identify best and
promising practices for the program to support sustainability,
replication, and dissemination of the program.
Likely Respondents: Respondents include project directors and staff
for the National Healthy Start Program Survey; representatives from
partner organizations for the Community Action Network Survey; program
staff, providers, and partners for the Healthy Start Site Visit
Protocol; and program participants for the Healthy Start Participant
Focus Group Protocol. Respondents for the redesigned 3Ps Information
Form (i.e., (1) Demographic Intake; (2) Pregnancy Status/History; (3)
Preconception; (4) Prenatal; (5) Postpartum; and (6) Interconception/
Parenting) are pregnant women and women of reproductive age 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 and 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
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
3Ps Information Form:
1. Demographic Intake Form.. * \+\ 40,675 1 40,675 0.08 3,254
2. Pregnancy Status/History. 40,675 1 40,675 0.17 6,915
3. Preconception............ * \+\ 20,337 1 20,337 1.00 20,337
4. Prenatal................. 20,337 1 20,337 1.00 20,337
5. Postpartum............... 20,337 1 20,337 1.00 20,337
16. Interconception/ 20,337 1 20,337 1.00 20,337
Parenting..................
National Healthy Start Program \+\ 100 1 100 2.00 200
Web Survey.....................
CAN member Web Survey........... \+\ 225 1 225 0.75 169
Healthy Start Site Visit \+\ 15 1 15 6.00 90
Protocol.......................
Healthy Start Participant Focus \+\ 180 1 180 1.00 180
Group Protocol.................
-------------------------------------------------------------------------------
Total....................... 61,532 .............. 61,532 .............. 92,156
----------------------------------------------------------------------------------------------------------------
* The same individuals (40,675) complete the Demographic Intake and Pregnancy Status/History forms, and a subset
of these same individuals (20,337) also complete the Preconception, Prenatal, Postpartum, and Interconception/
Parenting forms for total of 61,532 respondents and responses.
\+\ These are the numbers included in the total respondent count.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016-21889 Filed 9-12-16; 8:45 am]
BILLING CODE 4165-15-P
