Additional Comment Period for Updated HRSA-Supported Women's Preventive Services Guidelines Statement on Breastfeeding Services and Supplies, 70509-70510 [2021-26700]
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Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices
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I. Background
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Applicants must notify FDA of a change
to an approved BLA in accordance with
all statutory and regulatory
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70509
information. Therefore, clearance by the
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Dated: December 6, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021–26734 Filed 12–9–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Additional Comment Period for
Updated HRSA-Supported Women’s
Preventive Services Guidelines
Statement on Breastfeeding Services
and Supplies
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
On August 20, 2021, HRSA
published a notice soliciting public
comments regarding proposed updated
draft recommendations to the HRSASupported Women’s Preventive Services
Guidelines (Guidelines) in the areas of
Well-Women Preventive Visits,
Counseling for Sexually Transmitted
Infections, and Breastfeeding Services
and Supplies, which, when accepted by
HRSA, are required to be covered
without cost-sharing by certain health
insurance issuers under the Public
Health Service Act. The updated draft
recommendation statements were
developed through a national
cooperative agreement, the Women’s
Preventive Services Initiative (WPSI), by
SUMMARY:
E:\FR\FM\10DEN1.SGM
10DEN1
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70510
Federal Register / Vol. 86, No. 235 / Friday, December 10, 2021 / Notices
the American College of Obstetricians
and Gynecologists (ACOG). Since the
publication of that notice, WPSI has
further updated its recommendation
statement on Breastfeeding Services and
Supplies. HRSA encourages members of
the public to review this revised
updated recommendation statement and
provide comments for consideration.
DATES: Members of the public are
invited to provide written comments no
later than December 20, 2021. All
comments received on or before this
date will be reviewed and considered by
the WPSI Multidisciplinary Steering
Committee.
ADDRESSES: Members of the public
interested in providing comments on
the draft recommendation statements
can do so by accessing the initiative’s
web page at https://
www.womenspreventivehealth.org/.
FOR FURTHER INFORMATION CONTACT:
Kimberly Sherman, HRSA, Maternal
and Child Health Bureau, telephone
(301) 443–8283, email: wellwomancare@
hrsa.gov.
SUPPLEMENTARY INFORMATION: HRSA
established the Guidelines in 2011
based on a study and recommendations
by the Institute of Medicine, now
known as the National Academy of
Medicine, developed under a contract
with the Department of Health and
Human Services. Under section 1001(5)
of the Patient Protection and Affordable
Care Act, Public Law 111–148, which
added section 2713 to the Public Health
Service Act, 42 U.S.C. 300gg–13, the
preventive care and screenings set forth
in the Guidelines are required to be
covered without cost-sharing by certain
health insurance issuers. Since 2011,
there have been advancements in
science and gaps identified in these
guidelines, including a greater emphasis
on practice-based clinical
considerations. Accordingly, since
March 2016, HRSA has supported
cooperative agreements with ACOG to
convene a coalition representing
clinicians, academics, and consumerfocused health professional
organizations to conduct a rigorous
review of current scientific evidence
and make recommendations to HRSA
regarding updates to the Guidelines to
improve adult women’s health across
the lifespan. HRSA then decides
whether to support, in whole or in part,
the recommended updates to the
Guidelines. Under the cooperative
agreement, ACOG formed WPSI,
consisting of an Advisory Panel and two
expert committees, the
Multidisciplinary Steering Committee
(MSC) and the Dissemination and
Implementation Steering Committee
VerDate Sep<11>2014
17:03 Dec 09, 2021
Jkt 256001
(DISC), which are comprised of a broad
coalition of organizational
representatives who are experts in
disease prevention and women’s health
issues. Through oversight by the
Advisory Panel, MSC supports the
development and implementation of the
Guidelines through the review of
existing evidence and recommendation
development. Specifically, the MSC
examines the evidence to develop new
and update existing recommendations
for women’s preventive services. DISC
takes the HRSA-approved
recommendations, developed by the
MSC, and works to disseminate them
through the development of
implementation tools and resources for
both patients and practitioners.
In March 2021, ACOG engaged in a
process to consider and review new
information and evidence to determine
whether to recommend updates to the
Guidelines. ACOG bases its
recommended updates to the Guidelines
on review and synthesis of existing
clinical guidelines and new scientific
evidence, following the National
Academy of Medicine standards for
establishing foundations for and rating
strengths of recommendations,
articulation of recommendations, as
well as external reviews. Additionally,
ACOG incorporates processes to assure
opportunity for public comment,
including participation by patients and
consumers, in the development of the
updated Guideline recommendations.
This notice solicits comments from
the public on a revised draft
recommendation statement on
Breastfeeding Supplies and Services.
The updated draft recommendation
statement that was published on August
20, 2021 and the revised
recommendation statement that HRSA
recently received from ACOG are
provided below. WPSI will consider
and, as necessary, incorporate
additional public comment in its
recommendation statement. HRSA will
then decide whether to support, in
whole or in part, the recommended
updates to the Guidelines.
Clinical Recommendation Statement as
Published on August 20, 2021
The MSC updated clinical
recommendation included consultative
services to optimize successful
initiation and maintenance of
breastfeeding: ‘‘The WPSI recommends
comprehensive lactation support
services (including consultation,
counseling, education, and
breastfeeding equipment and supplies)
during the antenatal, perinatal, and
postpartum periods to optimize the
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Fmt 4703
Sfmt 4703
successful initiation and maintenance of
breastfeeding.’’
Revised Clinical Recommendation
Statement
The MSC has made two further
updates to the clinical recommendation
statement for breastfeeding. The first
addresses provider type in the provision
of breastfeeding services to reflect that
breastfeeding education can be provided
by clinicians and through peer support
services. The second update moves a
paragraph on breastfeeding equipment
and supplies from the implementation
section of the guideline into the clinical
recommendation component, making it
a substantive addition to the Guidelines
with corresponding effect under Section
2713. As revised, the clinical
recommendation statement provides:
‘‘The WPSI recommends comprehensive
lactation support services (including
consultation; counseling; education by
clinicians and peer support services;
and breastfeeding equipment and
supplies) during the antenatal,
perinatal, and postpartum periods to
optimize the successful initiation and
maintenance of breastfeeding.
Breastfeeding equipment and supplies
include, but are not limited to, double
electric breast pumps (including pump
parts and maintenance) and breast milk
storage supplies. Access to double
electric pumps should be a priority to
optimize breastfeeding and should not
be predicated on prior failure of a
manual pump. Breastfeeding equipment
may also include equipment and
supplies as clinically indicated to
support dyads with breastfeeding
difficulties and those who need
additional services.’’
Members of the public can view the
complete revised updated draft
recommendation statement by accessing
the initiative’s web page at https://
www.womenspreventivehealth.org/.
Diana Espinosa,
Acting Administrator.
[FR Doc. 2021–26700 Filed 12–9–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–NEW]
Agency Father Generic Information
Collection Request. 30-Day Public
Comment Request
Office of the Secretary, Health
and Human Service, HHS.
ACTION: Notice and request for
comments. Office of the Assistant
Secretary for Public Affairs is requesting
AGENCY:
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]]>Agencies
[Federal Register Volume 86, Number 235 (Friday, December 10, 2021)]
[Notices]
[Pages 70509-70510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-26700]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Additional Comment Period for Updated HRSA-Supported Women's
Preventive Services Guidelines Statement on Breastfeeding Services and
Supplies
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: On August 20, 2021, HRSA published a notice soliciting public
comments regarding proposed updated draft recommendations to the HRSA-
Supported Women's Preventive Services Guidelines (Guidelines) in the
areas of Well-Women Preventive Visits, Counseling for Sexually
Transmitted Infections, and Breastfeeding Services and Supplies, which,
when accepted by HRSA, are required to be covered without cost-sharing
by certain health insurance issuers under the Public Health Service
Act. The updated draft recommendation statements were developed through
a national cooperative agreement, the Women's Preventive Services
Initiative (WPSI), by
[[Page 70510]]
the American College of Obstetricians and Gynecologists (ACOG). Since
the publication of that notice, WPSI has further updated its
recommendation statement on Breastfeeding Services and Supplies. HRSA
encourages members of the public to review this revised updated
recommendation statement and provide comments for consideration.
DATES: Members of the public are invited to provide written comments no
later than December 20, 2021. All comments received on or before this
date will be reviewed and considered by the WPSI Multidisciplinary
Steering Committee.
ADDRESSES: Members of the public interested in providing comments on
the draft recommendation statements can do so by accessing the
initiative's web page at https://www.womenspreventivehealth.org/.
FOR FURTHER INFORMATION CONTACT: Kimberly Sherman, HRSA, Maternal and
Child Health Bureau, telephone (301) 443-8283, email:
[email protected].
SUPPLEMENTARY INFORMATION: HRSA established the Guidelines in 2011
based on a study and recommendations by the Institute of Medicine, now
known as the National Academy of Medicine, developed under a contract
with the Department of Health and Human Services. Under section 1001(5)
of the Patient Protection and Affordable Care Act, Public Law 111-148,
which added section 2713 to the Public Health Service Act, 42 U.S.C.
300gg-13, the preventive care and screenings set forth in the
Guidelines are required to be covered without cost-sharing by certain
health insurance issuers. Since 2011, there have been advancements in
science and gaps identified in these guidelines, including a greater
emphasis on practice-based clinical considerations. Accordingly, since
March 2016, HRSA has supported cooperative agreements with ACOG to
convene a coalition representing clinicians, academics, and consumer-
focused health professional organizations to conduct a rigorous review
of current scientific evidence and make recommendations to HRSA
regarding updates to the Guidelines to improve adult women's health
across the lifespan. HRSA then decides whether to support, in whole or
in part, the recommended updates to the Guidelines. Under the
cooperative agreement, ACOG formed WPSI, consisting of an Advisory
Panel and two expert committees, the Multidisciplinary Steering
Committee (MSC) and the Dissemination and Implementation Steering
Committee (DISC), which are comprised of a broad coalition of
organizational representatives who are experts in disease prevention
and women's health issues. Through oversight by the Advisory Panel, MSC
supports the development and implementation of the Guidelines through
the review of existing evidence and recommendation development.
Specifically, the MSC examines the evidence to develop new and update
existing recommendations for women's preventive services. DISC takes
the HRSA-approved recommendations, developed by the MSC, and works to
disseminate them through the development of implementation tools and
resources for both patients and practitioners.
In March 2021, ACOG engaged in a process to consider and review new
information and evidence to determine whether to recommend updates to
the Guidelines. ACOG bases its recommended updates to the Guidelines on
review and synthesis of existing clinical guidelines and new scientific
evidence, following the National Academy of Medicine standards for
establishing foundations for and rating strengths of recommendations,
articulation of recommendations, as well as external reviews.
Additionally, ACOG incorporates processes to assure opportunity for
public comment, including participation by patients and consumers, in
the development of the updated Guideline recommendations.
This notice solicits comments from the public on a revised draft
recommendation statement on Breastfeeding Supplies and Services. The
updated draft recommendation statement that was published on August 20,
2021 and the revised recommendation statement that HRSA recently
received from ACOG are provided below. WPSI will consider and, as
necessary, incorporate additional public comment in its recommendation
statement. HRSA will then decide whether to support, in whole or in
part, the recommended updates to the Guidelines.
Clinical Recommendation Statement as Published on August 20, 2021
The MSC updated clinical recommendation included consultative
services to optimize successful initiation and maintenance of
breastfeeding: ``The WPSI recommends comprehensive lactation support
services (including consultation, counseling, education, and
breastfeeding equipment and supplies) during the antenatal, perinatal,
and postpartum periods to optimize the successful initiation and
maintenance of breastfeeding.''
Revised Clinical Recommendation Statement
The MSC has made two further updates to the clinical recommendation
statement for breastfeeding. The first addresses provider type in the
provision of breastfeeding services to reflect that breastfeeding
education can be provided by clinicians and through peer support
services. The second update moves a paragraph on breastfeeding
equipment and supplies from the implementation section of the guideline
into the clinical recommendation component, making it a substantive
addition to the Guidelines with corresponding effect under Section
2713. As revised, the clinical recommendation statement provides: ``The
WPSI recommends comprehensive lactation support services (including
consultation; counseling; education by clinicians and peer support
services; and breastfeeding equipment and supplies) during the
antenatal, perinatal, and postpartum periods to optimize the successful
initiation and maintenance of breastfeeding. Breastfeeding equipment
and supplies include, but are not limited to, double electric breast
pumps (including pump parts and maintenance) and breast milk storage
supplies. Access to double electric pumps should be a priority to
optimize breastfeeding and should not be predicated on prior failure of
a manual pump. Breastfeeding equipment may also include equipment and
supplies as clinically indicated to support dyads with breastfeeding
difficulties and those who need additional services.''
Members of the public can view the complete revised updated draft
recommendation statement by accessing the initiative's web page at
https://www.womenspreventivehealth.org/.
Diana Espinosa,
Acting Administrator.
[FR Doc. 2021-26700 Filed 12-9-21; 8:45 am]
BILLING CODE 4165-15-P
