Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Healthy Start Evaluation and Quality Improvement, 62911-62912 [2016-21889]

Download as PDF Federal Register / Vol. 81, No. 177 / Tuesday, September 13, 2016 / Notices Lhorne on DSK30JT082PROD with NOTICES 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 In the Federal Register of December 15, 2015 (80 FR 77645), FDA announced the availability of the draft guidance entitled ‘‘Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Living Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps); Draft Guidance for Industry’’ dated December 2015 (December 2015 draft guidance). FDA received several comments on the draft guidance and those comments were considered as the guidance was developed.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 The guidance announced in this notice finalizes the December 2015 draft guidance and supplements sections IV.E. (recommendations 15 and 16) and IV.F. (recommendation 5), and supersedes the ‘‘West Nile Virus (WNV)’’ section in Appendix 6 of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 http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm or http://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] BILLING CODE 4165–15–P 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 Fmt 4703 Sfmt 4703 Dated: September 6, 2016. Jennifer Spaeth, Director, Office of Federal Advisory Committee Policy. [FR Doc. 2016–21899 Filed 9–12–16; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Institute of Diabetes and Digestive and Kidney Diseases; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as E:\FR\FM\13SEN1.SGM 13SEN1

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]


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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