Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Healthy Start Evaluation and Quality Improvement, OMB No. 0915-0338-Revision, 60095-60096 [2019-24278]

Download as PDF Federal Register / Vol. 84, No. 216 / Thursday, November 7, 2019 / Notices for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Eileen Wu, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 3472, Silver Spring, MD 20993–0002, 301–796–2345, eileen.wu@fda.hhs.gov; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240–402–7911. SUPPLEMENTARY INFORMATION: I. Background FDA is establishing a public docket to collect comments on a draft document entitled ‘‘Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff.’’ Title IX, section 915 of the Food and Drug Administration Amendments Act of 2007 (FDAAA) added a new section 505(r) to the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(r)), requiring FDA to prepare a summary analysis of the adverse drug reaction reports received for a drug by 18 months after approval or after use of the drug by 10,000 individuals, whichever is later. The analysis includes identification of any new risks not previously identified, potential new risks, or known risks reported in unusual number. The Cures Act (Pub. L. 114–255) was enacted on December 13, 2016, and has the goal of advancing medical product VerDate Sep<11>2014 19:40 Nov 06, 2019 Jkt 250001 innovation, as well as ensuring patient access to safe and effective treatments as soon as possible. Section 3075 of the Cures Act amended section 505(r)(2)(D) of the FD&C Act to eliminate the requirement for summary analyses for drugs as required by FDAAA. In place of the summary analyses, section 3075 amended section 505(r)(2)(D) of the FD&C Act to include the requirement that FDA make publicly available on its internet website best practices for drug safety surveillance activities for drugs approved under section 505 of the FD&C Act or section 351 of the Public Health Service Act (PHS Act). Section 3075 of the Cures Act also amended section 505(k)(5) of the FD&C Act to strike ‘‘bi-weekly screening’’, as required by FDAAA, and insert ‘‘screenings’’; it also added the requirement that FDA make publicly available on its internet website guidelines, developed with input from experts qualified by scientific training and experience to evaluate the safety and effectiveness of drugs, that detail best practices for drug safety surveillance using the Adverse Event Reporting System. The draft document entitled ‘‘Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff’’ sets forth risk-based principles by which FDA conducts ongoing postmarketing safety surveillance for drug and biological products to address the Cures Act requirements. Although section 3075 of the Cures Act only references drugs approved under section 505 of the FD&C Act or section 351 of the PHS Act, the draft document additionally provides a high-level discussion regarding other products, including over-the-counter monograph, compounded, and homeopathic drug products. The draft document also includes a high-level overview of other data sources, tools, and methods, as well as drug safety surveillance activities that extend beyond use of the Adverse Event Reporting System (and its successors). These additional topics are included to provide context and a general overview of FDA’s safety surveillance process. FDA is seeking public comment on the draft best practices document before it begins work on the final version, which will be made publicly available. II. Electronic Access Persons with access to the internet may obtain the draft document entitled ‘‘Best Practices in Drug and Biological Product Postmarket Safety Surveillance for FDA Staff’’ at https://www.fda.gov/ media/130216/download. PO 00000 Frm 00044 Fmt 4703 Sfmt 4703 60095 Dated: November 1, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–24332 Filed 11–6–19; 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; Information Collection Request Title: Healthy Start Evaluation and Quality Improvement, OMB No. 0915–0338—Revision Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with 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 December 9, 2019. SUMMARY: Submit your comments, including the ICR 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 Lisa Wright-Solomon, 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 racial and ethnic disparities in infant mortality and other adverse perinatal outcomes. The program began as a demonstration project with 15 grantees in 1991 and since then has expanded to 101 grantees serving communities in 34 states, Washington, DC, and Puerto ADDRESSES: E:\FR\FM\07NON1.SGM 07NON1 60096 Federal Register / Vol. 84, No. 216 / Thursday, November 7, 2019 / Notices Rico. Healthy Start grantees serve communities with high rates of poor perinatal outcomes, including infant mortality at least 1.5 times the U.S. national average. These communities are often low-income and in geographically, racially, ethnically, and linguistically diverse areas. Healthy Start offers services during the perinatal period (before, during, and after pregnancy) and the program works with women, infants, and families through the first 18 months after birth. The Healthy Start program uses four approaches to reduce infant mortality through individual services and community support to women, infants, and families: (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, MCHB has sought to implement a uniform set of data elements for monitoring and conducting an evaluation to assess grantees’ progress towards these program approaches. Under the current OMB approval, the data collection instruments for this evaluation include the following: The National Healthy Start Program Survey; Community Action Network Survey; Healthy Start Site Visit Protocol; Healthy Start Participant Focus Group Protocol; and six client-level screening tools: (1) Demographic Intake Form, (2) Pregnancy Status/History, (3) Preconception, (4) Prenatal, (5) Postpartum, and (6) Interconception/ Parenting. In this proposed revision, MCHB plans to retain the client-level tools, and to eliminate the National Healthy Start Program Survey, Community Action Network Survey, Healthy Start Site Visit Protocol, and Healthy Start Participant Focus Group Protocol instruments. These instruments have been removed to streamline this data collection activity for the evaluation. For the six client-level tools, MCHB plans to consolidate these into three forms: (1) Background, (2) Prenatal, and (3) Parent/Child. These tools have been revised based on the public comments received during the 60-day comment period. The purpose of these changes is to consolidate items that are duplicated across the forms. In addition to consolidating questions across tools, many individual items have been eliminated or in some cases reworded in order to focus the evaluation more clearly on individual and programmatic progress on performance measures. This will shorten the revised instruments, center them more clearly on program improvement, and decrease the number of personal/sensitive questions. In addition to the elimination, consolidation, and rewording of several items, questions designed to increase efficiency and accuracy in reporting have been added. Specifically, many of the grantees’ annual reporting requirements require calculations based on infants’ birth dates, estimated due dates, dates enrolled in the Healthy Start program, trimester in which certain health-related activities occurred, and so on. These revised tools include the information necessary to make these calculations so that annual aggregate reporting will be based on individual client-level data. This will increase accountability, efficiency, and accuracy in terms of the clients served as well as reduce overall burden on the grantees by streamlining reporting systems. A 60-day notice was published in the Federal Register on January 31, 2019, vol. 84, no. 21, pp. 753–754. There were 16 public comments. Need and Proposed Use of the Information: The purpose of the revised data collection instruments will be to assess grantee and client-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: Respondents include pregnant women and nonpregnant women of reproductive age who are served by the Healthy Start program as well as any of their spouses/ partners or other caregivers who are participating in receiving Healthy Start services. 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. Compared to the versions submitted for the 60-day approval process in January, estimated burden hours have increased somewhat as a result of implementing the feedback provided in public comments during the 60-day comment period. 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 Average burden per response (in hours) Total responses Total burden hours Background .......................................................................... Prenatal ................................................................................ Parent/Child ......................................................................... * 55,550 * 30,300 * 30,300 1 1 1 55,550 30,300 30,300 .50 .17 .42 27,775 5,151 12,726 Total .............................................................................. 116,150 ........................ 116,150 ........................ 45,652 * All participants (55,550) complete the Background form, and a subset of these same individuals (30,300) also complete the Prenatal or Parent/Child forms, for a total of 116,150 responses. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2019–24278 Filed 11–6–19; 8:45 am] BILLING CODE 4165–15–P VerDate Sep<11>2014 17:55 Nov 06, 2019 Jkt 250001 PO 00000 Frm 00045 Fmt 4703 Sfmt 9990 E:\FR\FM\07NON1.SGM 07NON1

Agencies

[Federal Register Volume 84, Number 216 (Thursday, November 7, 2019)]
[Notices]
[Pages 60095-60096]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-24278]


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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; 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 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 December 
9, 2019.

ADDRESSES: Submit your comments, including the ICR 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 Lisa Wright-Solomon, 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 
racial and ethnic disparities in infant mortality and other adverse 
perinatal outcomes. The program began as a demonstration project with 
15 grantees in 1991 and since then has expanded to 101 grantees serving 
communities in 34 states, Washington, DC, and Puerto

[[Page 60096]]

Rico. Healthy Start grantees serve communities with high rates of poor 
perinatal outcomes, including infant mortality at least 1.5 times the 
U.S. national average. These communities are often low-income and in 
geographically, racially, ethnically, and linguistically diverse areas. 
Healthy Start offers services during the perinatal period (before, 
during, and after pregnancy) and the program works with women, infants, 
and families through the first 18 months after birth. The Healthy Start 
program uses four approaches to reduce infant mortality through 
individual services and community support to women, infants, and 
families: (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, MCHB has sought to implement a 
uniform set of data elements for monitoring and conducting an 
evaluation to assess grantees' progress towards these program 
approaches. Under the current OMB approval, the data collection 
instruments for this evaluation include the following: The National 
Healthy Start Program Survey; Community Action Network Survey; Healthy 
Start Site Visit Protocol; Healthy Start Participant Focus Group 
Protocol; and six client-level screening tools: (1) Demographic Intake 
Form, (2) Pregnancy Status/History, (3) Preconception, (4) Prenatal, 
(5) Postpartum, and (6) Interconception/Parenting.
    In this proposed revision, MCHB plans to retain the client-level 
tools, and to eliminate the National Healthy Start Program Survey, 
Community Action Network Survey, Healthy Start Site Visit Protocol, and 
Healthy Start Participant Focus Group Protocol instruments. These 
instruments have been removed to streamline this data collection 
activity for the evaluation. For the six client-level tools, MCHB plans 
to consolidate these into three forms: (1) Background, (2) Prenatal, 
and (3) Parent/Child. These tools have been revised based on the public 
comments received during the 60-day comment period. The purpose of 
these changes is to consolidate items that are duplicated across the 
forms. In addition to consolidating questions across tools, many 
individual items have been eliminated or in some cases reworded in 
order to focus the evaluation more clearly on individual and 
programmatic progress on performance measures. This will shorten the 
revised instruments, center them more clearly on program improvement, 
and decrease the number of personal/sensitive questions.
    In addition to the elimination, consolidation, and rewording of 
several items, questions designed to increase efficiency and accuracy 
in reporting have been added. Specifically, many of the grantees' 
annual reporting requirements require calculations based on infants' 
birth dates, estimated due dates, dates enrolled in the Healthy Start 
program, trimester in which certain health-related activities occurred, 
and so on. These revised tools include the information necessary to 
make these calculations so that annual aggregate reporting will be 
based on individual client-level data. This will increase 
accountability, efficiency, and accuracy in terms of the clients served 
as well as reduce overall burden on the grantees by streamlining 
reporting systems.
    A 60-day notice was published in the Federal Register on January 
31, 2019, vol. 84, no. 21, pp. 753-754. There were 16 public comments.
    Need and Proposed Use of the Information: The purpose of the 
revised data collection instruments will be to assess grantee and 
client-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: Respondents include pregnant women and non-
pregnant women of reproductive age who are served by the Healthy Start 
program as well as any of their spouses/partners or other caregivers 
who are participating in receiving Healthy Start services.
    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. Compared to the versions submitted for the 
60-day approval process in January, estimated burden hours have 
increased somewhat as a result of implementing the feedback provided in 
public comments during the 60-day comment period. The total annual 
burden hours estimated for this ICR are summarized in the table below.

                                     Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
                                                     Number of                    Average burden
            Form name                Number of     responses per       Total       per response    Total burden
                                    respondents     respondent       responses      (in hours)         hours
----------------------------------------------------------------------------------------------------------------
Background......................        * 55,550               1          55,550             .50          27,775
Prenatal........................        * 30,300               1          30,300             .17           5,151
Parent/Child....................        * 30,300               1          30,300             .42          12,726
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
    Total.......................         116,150  ..............         116,150  ..............          45,652
----------------------------------------------------------------------------------------------------------------
* All participants (55,550) complete the Background form, and a subset of these same individuals (30,300) also
  complete the Prenatal or Parent/Child forms, for a total of 116,150 responses.


Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2019-24278 Filed 11-6-19; 8:45 am]
 BILLING CODE 4165-15-P