81 FR 62911 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Healthy Start Evaluation and Quality Improvement
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 81, Issue 177 (September 13, 2016)
Health Resources and Services Administration
Federal Register Volume 81, Issue 177 (September 13, 2016)
| Page Range | 62911-62912 | |
| FR Document | 2016-21889 |
[Federal Register Volume 81, Number 177 (Tuesday, September 13, 2016)] [Notices] [Pages 62911-62912] From the Federal Register Online [www.thefederalregister.org] [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 [email protected] 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 [email protected] 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
![Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices 62911
I. Background (HCT/Ps).’’ It does not establish any Abstract: The National Healthy Start
FDA is announcing the availability of rights for any person and is not binding Program, funded through HRSA’s
a document entitled ‘‘Use of Nucleic on FDA or the public. You can use an Maternal and Child Health Bureau
Acid Tests to Reduce the Risk of alternative approach if it satisfies the (MCHB), has the goal of reducing
Transmission of West Nile Virus From requirements of the applicable statutes disparities in infant mortality and
Living Donors of Human Cells, Tissues, and regulations. adverse perinatal outcomes. The
and Cellular and Tissue-Based Products II. Electronic Access program began as a demonstration
(HCT/Ps); Guidance for Industry.’’ The project with 15 grantees in 1991 and has
Persons with access to the Internet expanded over the past 2 decades to 100
guidance document provides may obtain the guidance at either http://
establishments that make donor grantees across 37 states and
www.fda.gov/BiologicsBloodVaccines/ Washington, DC. Healthy Start grantees
eligibility determinations for donors of GuidanceComplianceRegulatory
HCT/Ps with recommendations for operate in communities with rates of
Information/Guidances/default.htm or infant mortality at least 1.5 times the
testing living donors for WNV. The http://www.regulations.gov.
guidance does not provide U.S. national average and high rates for
recommendations regarding testing of Dated: September 8, 2016. other adverse perinatal outcomes. These
cadaveric HCT/P donors for WNV. FDA Leslie Kux, communities are geographically,
believes that the use of an FDA-licensed Associate Commissioner for Policy. racially, ethnically, and linguistically
NAT will reduce the risk of [FR Doc. 2016–21969 Filed 9–12–16; 8:45 am] diverse low-income areas. Healthy Start
transmission of WNV from living donors BILLING CODE 4164–01–P
covers services during the perinatal
of HCT/Ps and therefore recommends period (before, during, after pregnancy)
that you use an FDA-licensed NAT for and follows the woman and infant
testing living donors of HCT/Ps for DEPARTMENT OF HEALTH AND through 2 years after the end of the
infection with WNV as set forth in the HUMAN SERVICES pregnancy. The Healthy Start program
guidance. The 2007 Donor Eligibility has five approaches including: (1)
Health Resources and Services Improving women’s health; (2)
Guidance indicated that FDA may
Administration promoting quality services; (3)
recommend routine use of an
appropriate, licensed donor screening strengthening family resilience; (4)
Agency Information Collection achieving collective impact; and (5)
test(s) to detect acute infections with Activities: Submission to OMB for
WNV using NAT technology, once such increasing accountability through
Review and Approval; Public Comment quality assurance, performance
tests were available. Request; Healthy Start Evaluation and
In the Federal Register of December monitoring, and evaluation.
Quality Improvement
15, 2015 (80 FR 77645), FDA announced MCHB seeks to implement a uniform
the availability of the draft guidance AGENCY: Health Resources and Services set of data elements for monitoring and
entitled ‘‘Use of Nucleic Acid Tests to Administration (HRSA), Department of conducting a mixed-methods evaluation
Reduce the Risk of Transmission of Health and Human Services. to assess the effectiveness of the
West Nile Virus from Living Donors of ACTION: Notice. program on individual, organizational,
Human Cells, Tissues, and Cellular and and community-level outcomes. Data
Tissue-Based Products (HCT/Ps); Draft SUMMARY: In compliance with section collection instruments will include a
Guidance for Industry’’ dated December 3507(a)(1)(D) of the Paperwork National Healthy Start Program Survey;
Reduction Act of 1995, HRSA has Community Action Network Survey;
2015 (December 2015 draft guidance).
submitted an Information Collection Healthy Start Site Visit Protocol;
FDA received several comments on the
Request (ICR) to the Office of Healthy Start Participant Focus Group
draft guidance and those comments
Management and Budget (OMB) for Protocol—these instruments have not
were considered as the guidance was
review and approval. Comments been changed. The Preconception,
developed.
submitted during the first public review Pregnancy and Parenting (3Ps)
In the Federal Register of February
of this ICR will be provided to OMB. Information Form will also be used as
28, 2007 (72 FR 9007), FDA announced
OMB will accept further comments from a data collection instrument; however
the availability of the 2007 Donor
the public during the review and the 3Ps Information Form has been
Eligibility Guidance. FDA issued a
approval period. redesigned from one form into six
revised version of this guidance under
the same title, dated August 2007 (2007 DATES: Comments on this ICR should be forms. The six forms include: (1)
Donor Eligibility Guidance). received no later than October 13, 2016. Demographic Intake Form; (2)
The guidance announced in this ADDRESSES: Submit your comments, Pregnancy Status/History; (3)
notice finalizes the December 2015 draft including the Information Collection Preconception; (4) Prenatal; (5)
guidance and supplements sections Request Title, to the desk officer for Postpartum; and (6) Interconception/
IV.E. (recommendations 15 and 16) and HRSA, either by email to OIRA_ Parenting. The purpose of this redesign
IV.F. (recommendation 5), and submission@omb.eop.gov or by fax to is to enhance the 3Ps Information Form
supersedes the ‘‘West Nile Virus 202–395–5806. to ensure collected data is meaningful
(WNV)’’ section in Appendix 6 of the FOR FURTHER INFORMATION CONTACT: To for monitoring and evaluation, as well
2007 Donor Eligibility Guidance. request a copy of the clearance requests as screening and care coordination, and
The guidance is being issued submitted to OMB for review, email the streamline previously separate data
consistent with FDA’s good guidance HRSA Information Collection Clearance systems. The 3Ps Information Form was
Officer at paperwork@hrsa.gov or call
Lhorne on DSK30JT082PROD with NOTICES
practices regulation (21 CFR 10.115). also redesigned to allow questions to be
The guidance represents the current (301) 443–1984. administered in accordance with the
thinking of FDA on ‘‘Use of Nucleic SUPPLEMENTARY INFORMATION: participant’s enrollment/service
Acid Tests to Reduce the Risk of Information Collection Request Title: delivery status and perinatal period. In
Transmission of West Nile Virus from Healthy Start Evaluation and Quality addition to redesigning the 3Ps
Living Donors of Human Cells, Tissues, Improvement OMB No. 0915–0338— Information Form, HRSA deleted
and Cellular and Tissue-Based Products Revision questions that are neither critical for
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![62912 Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices
evaluation nor programmatic purposes. program effect on outcomes; (3) assess Preconception; (4) Prenatal; (5)
HRSA also added questions to the 3Ps the relative contribution of the five Postpartum; and (6) Interconception/
Information Form to allow the Form to program approaches to individual and Parenting) are pregnant women and
be used as an all-inclusive data community-level outcomes; (4) meet women of reproductive age who are
collection instrument for MCHB and program needs for accountability, served by the Healthy Start Program.
Healthy Start grantees. The additional programmatic decision-making, and Burden Statement: Burden in this
questions extend and refine previously ongoing quality assurance; and (5) context means the time expended by
approved content, allowing for the strengthen the evidence-base, and persons to generate, maintain, retain,
collection of more granular and/or in- identify best and promising practices for disclose or provide the information
depth information on existing topics. the program to support sustainability, requested. This includes the time
Adding these questions allows Healthy replication, and dissemination of the needed to review instructions; to
Start grantees to better assess risk, program. develop, acquire, install and utilize
identify needed services, provide Likely Respondents: Respondents technology and systems for the purpose
appropriate follow-up activities to include project directors and staff for of collecting, validating and verifying
program participants, and improve the National Healthy Start Program information, processing and
overall service delivery and quality. Survey; representatives from partner maintaining information, and disclosing
Need and Proposed Use of the organizations for the Community Action and providing information; to train
Information: The purpose of the data Network Survey; program staff, personnel and to be able to respond to
collection instruments is to obtain providers, and partners for the Healthy a collection of information; to search
consistent information across all Start Site Visit Protocol; and program data sources; to complete and review
grantees about Healthy Start and its participants for the Healthy Start the collection of information; and to
outcomes. The data will be used to: (1) Participant Focus Group Protocol. transmit or otherwise disclose the
Conduct ongoing performance Respondents for the redesigned 3Ps information. The total annual burden
monitoring of the program; (2) provide Information Form (i.e., (1) Demographic hours estimated for this ICR are
credible and rigorous evidence of Intake; (2) Pregnancy Status/History; (3) summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Average
Number of
Number of Total burden per Total burden
Form name responses per
respondents responses response hours
respondent (in 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
6. Interconception/Parenting ......................................... 20,337 1 20,337 1.00 20,337
National Healthy Start Program Web Survey ...................... + 100 1 100 2.00 200
CAN member Web Survey .................................................. + 225 1 225 0.75 169
Healthy Start Site Visit Protocol .......................................... + 15 1 15 6.00 90
Healthy Start Participant Focus Group Protocol ................. + 180 1 180 1.00 180
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 re-
sponses.
+ These are the numbers included in the total respondent count.
Jason E. Bennett, was renewed for an additional two-year Dated: September 6, 2016.
Director, Division of the Executive Secretariat. period on August 31, 2016. Jennifer Spaeth,
[FR Doc. 2016–21889 Filed 9–12–16; 8:45 am] It is determined that the Fogarty Director, Office of Federal Advisory
BILLING CODE 4165–15–P International Center Advisory Board is Committee Policy.
in the public interest in connection with [FR Doc. 2016–21899 Filed 9–12–16; 8:45 am]
the performance of duties imposed on BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND the National Institutes of Health by law,
HUMAN SERVICES and that these duties can best be
performed through the advice and DEPARTMENT OF HEALTH AND
National Institutes of Health counsel of this group. HUMAN SERVICES
Office of the Director Notice of Charter Inquiries may be directed to Jennifer National Institutes of Health
Spaeth, Director, Office of Federal
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Document Created: 2018-02-09 13:16:49
Document Modified: 2018-02-09 13:16:49
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than October 13, 2016. | |
| Contact | To request a copy of the clearance requests submitted to OMB for review, email the HRSA Information Collection Clearance Officer at [email protected] or call (301) 443- 1984. | |
| FR Citation | 81 FR 62911 |
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