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]
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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
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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.
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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
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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]
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]]>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]
-----------------------------------------------------------------------
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
