Updated HRSA-Supported Women's Preventive Services Guidelines: Well-Women Preventive Visits, Counseling for Sexually Transmitted Infections, and Breastfeeding Services and Supplies, 46856-46857 [2021-17826]
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46856
Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices
A 60-day notice published in the
Federal Register on April 20, 2021, vol.
86, No. 74, pp. 20499–20500. No public
comments were received in response to
the ICR.
Need and Proposed Use of the
Information: HRSA uses the
documentation submitted in core
medical services waiver requests to
determine if the grant applicant or
recipient meets the statutory
requirements for waiver eligibility
outlined in Sections 2604(c), 2612(b),
and 2651(c) of the Public Health Service
Act.
Likely Respondents: HRSA expects
responses from RWHAP Parts A, B, and
C grant applicants and recipients. The
number of grant recipients requesting
waivers has fluctuated annually and has
ranged from 15 to 22 per year since the
waiver process was implemented in FY
2007.
Given the changes in the health care
environment, HRSA anticipates
receiving possibly up to 22 applications
in a given year.
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
Waiver Request ...................................................................
HRSA notes that this proposed
process represents a decrease in burden
when compared to the current policy
outlined in PN 13–07 due in part to the
elimination of the requirement to
prepare and submit a narrative and
multiple documents. HRSA specifically
requests comments on (1) the necessity
and utility of the proposed information
collection for the proper performance of
the agency’s functions, (2) the accuracy
of the estimated burden, (3) ways to
enhance the quality, utility, and clarity
of the information to be collected, and
(4) the use of automated collection
techniques or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2021–17834 Filed 8–19–21; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
Health Resources and Services
Administration
Updated HRSA-Supported Women’s
Preventive Services Guidelines: WellWomen Preventive Visits, Counseling
for Sexually Transmitted Infections,
and Breastfeeding Services and
Supplies
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
AGENCY:
VerDate Sep<11>2014
17:27 Aug 19, 2021
Jkt 253001
ACTION:
Number of
responses per
respondent
22
4
88
22
........................
22
........................
88
FOR FURTHER INFORMATION CONTACT:
This notice seeks comments
on an updated draft recommendation for
Well-Woman Preventive Visits,
Counseling for Sexually Transmitted
Infections, and Breastfeeding Services
and Supplies, as part of the HRSAsupported Women’s Preventive Services
Guidelines. This updated draft
recommendation has been developed
through a national cooperative
agreement, the Women’s Preventive
Services Initiative (WPSI), by the
American College of Obstetricians and
Gynecologists (ACOG). Under the Public
Health Service Act, as added by the
Patient Protection and Affordable Care
Act, non-grandfathered group health
plans and non-grandfathered group and
individual health insurance issuers
must include coverage, without cost
sharing, for certain preventive services
under that section, including those
provided for in the HRSA-supported
Women’s Preventive Services
Guidelines (Guidelines).
DATES: Members of the public are
invited to provide written comments no
later than September 20, 2021. All
comments received on or before this
date will be reviewed and considered by
the WPSI Multidisciplinary Steering
Committee.
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.womens
preventivehealth.org/.
ADDRESSES:
Fmt 4703
Total burden
hours
1
Notice.
Frm 00036
Average
burden per
response
(in hours)
22
SUMMARY:
PO 00000
Total
responses
Sfmt 4703
Kimberly Sherman, HRSA, Maternal
and Child Health Bureau, telephone
(301) 443–8283, email: wellwomancare@
hrsa.gov.
The
HRSA-supported Women’s Preventive
Services Guidelines were originally
established in 2011 based on a study
and recommendations by the Institute of
Medicine, now known as the National
Academy of Medicine, commissioned
by HHS. Since then, there have been
advancements in science and gaps
identified in these guidelines, including
a greater emphasis on practice-based
clinical considerations. In March 2016,
HRSA awarded a 5-year cooperative
agreement to convene a coalition
representing clinicians, academics, and
consumer-focused health professional
organizations to conduct a rigorous
review of current scientific evidence
and recommend updates to existing
guidelines. The ACOG was awarded the
cooperative agreement and formed the
WPSI, which consists of an Advisory
Panel and two expert committees; the
Multidisciplinary Steering Committee
(MSC) and the Dissemination and
Implementation Steering Committee, to
improve adult women’s health across
the lifespan by engaging a coalition of
health professional organizations to
review evidence and recommend
updates to the HRSA-supported
Women’s Preventive Services
Guidelines. HRSA would then decide
whether or not to support, in whole or
SUPPLEMENTARY INFORMATION:
E:\FR\FM\20AUN1.SGM
20AUN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 86, No. 159 / Friday, August 20, 2021 / Notices
in part, the recommended updates to the
Guidelines.
In March 2021, ACOG was awarded a
subsequent cooperative agreement to
further review and recommend updates
to the Guidelines. As the award
recipient, starting on March 1, 2021,
ACOG has engaged in a process to
consider and review new information
developed by a multidisciplinary group
of women’s health professional
organizations. Following
recommendations by ACOG, HRSA will
decide whether to support, in whole or
in part, the recommended updates to the
guidelines.
As part of this cooperative agreement,
ACOG is required to base its
recommended updates to the Guidelines
on review and synthesis of existing
clinical guidelines and new scientific
evidence. The National Academy of
Medicine standards for establishing
foundations for and rating strengths of
recommendations, articulation of
recommendations, as well as external
reviews are to be met in developing
these guidelines. Additionally,
processes are to be incorporated to
assure opportunity for public input and
transparency, including participation by
patients and consumers, in the
development of the updated Guideline
recommendations.
This notice solicits comments from
the public on the draft recommendation
statements for the Well-Woman
Preventive Visits, Counseling for
Sexually Transmitted Infections, and
Breastfeeding Services and Supplies.
The updated draft clinical
recommendation statements are
provided below:
recommended preventive services as
determined by age and risk factors.’’
Well Woman Preventive Visits
The MSC has updated the clinical
recommendation statement to reflect
that recommended services may be
completed at a single visit or as part of
a series of preventive health visits that
take place over time to obtain the
necessary services. Well Women Visits
have also been further defined to
include pre-pregnancy, prenatal, and
interpregnancy visits.
Members of the public can view each
complete updated draft
recommendation statement by accessing
the initiative’s web page at https://
www.womenspreventivehealth.org/.
‘‘The WPSI recommends that women
receive at least one preventive care visit per
year beginning in adolescence and
continuing across the lifespan to ensure the
provision of all recommended preventive
services. These services may be completed at
a single visit or as part of a series of visits
that take place over time to obtain all
necessary services depending on a woman’s
age, health status, reproductive health needs,
pregnancy status, and risk factors. Well
women visits include pre-pregnancy,
prenatal, and interpregnancy visits. The
primary purpose of well-woman visits is the
delivery and coordination of all
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
VerDate Sep<11>2014
17:27 Aug 19, 2021
Jkt 253001
Counseling for Sexually Transmitted
Infections
The MSC has made minor updates to
the counseling for sexually transmitted
infections statement to include a review
of a women’s sexual history, and
modified the risk factor list by stating
that risk factors are ‘‘not limited to’’ the
areas indicated.
‘‘The WPSI recommends directed
behavioral counseling by a health care
provider or other appropriately trained
individual for sexually active adolescent and
adult women at an increased risk for sexually
transmitted infections (STIs).
The WPSI recommends that health care
providers review a woman’s sexual history
and risk factors to help identify those at an
increased risk of STIs. Risk factors include
but are not limited to age younger than 25
years, a recent history of an STI, a new sex
partner, multiple partners, a partner with
concurrent partners, a partner with an STI,
and a lack of or inconsistent condom use. For
adolescents and women not identified as
high risk, counseling to reduce the risk of
STIs should be considered, as determined by
clinical judgment.’’
Breastfeeding Services and Supplies
The MSC has updated the clinical
recommendation to include consultative
services that will 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.’’
Diana Espinosa,
Acting Administrator.
[FR Doc. 2021–17826 Filed 8–19–21; 8:45 am]
BILLING CODE 4165–15–P
National Institutes of Health
National Institute on Aging; Notice of
Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings will be closed to the
public in accordance with the
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
46857
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Aging and
Metabolic Plasticity of Adipose Tissue.
Date: October 19, 2021.
Time: 12:00 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Joshua Jin-Hyouk Park,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, Gateway
Building 2W200, 7201 Wisconsin Avenue,
Bethesda, MD 20892, (301) 496–6208,
joshua.park4@nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; MOST4
Osteoarthritis Study.
Date: October 27, 2021.
Time: 12:00 p.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Joshua Jin-Hyouk Park,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, Gateway
Building 2W200, 7201 Wisconsin Avenue,
Bethesda, MD 20892, (301) 496–6208,
joshua.park4@nih.gov.
Name of Committee: National Institute on
Aging Special Emphasis Panel; Neurogenesis
Dynamics in AD and ADRD.
Date: November 9–10, 2021.
Time: 11:00 a.m. to 5:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institute on Aging,
Gateway Building, 7201 Wisconsin Avenue,
Bethesda, MD 20892 (Video Meeting).
Contact Person: Joshua Jin-Hyouk Park,
Ph.D., Scientific Review Officer, Scientific
Review Branch, National Institute on Aging,
National Institutes of Health, Gateway
Building 2W200, 7201 Wisconsin Avenue,
Bethesda, MD 20892, (301) 496–6208,
joshua.park4@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.866, Aging Research,
National Institutes of Health, HHS)
Dated: August 17, 2021.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2021–17877 Filed 8–19–21; 8:45 am]
BILLING CODE 4140–01–P
E:\FR\FM\20AUN1.SGM
20AUN1
Agencies
[Federal Register Volume 86, Number 159 (Friday, August 20, 2021)]
[Notices]
[Pages 46856-46857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-17826]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Updated HRSA-Supported Women's Preventive Services Guidelines:
Well-Women Preventive Visits, Counseling for Sexually Transmitted
Infections, and Breastfeeding Services and Supplies
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice seeks comments on an updated draft recommendation
for Well-Woman Preventive Visits, Counseling for Sexually Transmitted
Infections, and Breastfeeding Services and Supplies, as part of the
HRSA-supported Women's Preventive Services Guidelines. This updated
draft recommendation has been developed through a national cooperative
agreement, the Women's Preventive Services Initiative (WPSI), by the
American College of Obstetricians and Gynecologists (ACOG). Under the
Public Health Service Act, as added by the Patient Protection and
Affordable Care Act, non-grandfathered group health plans and non-
grandfathered group and individual health insurance issuers must
include coverage, without cost sharing, for certain preventive services
under that section, including those provided for in the HRSA-supported
Women's Preventive Services Guidelines (Guidelines).
DATES: Members of the public are invited to provide written comments no
later than September 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: The HRSA-supported Women's Preventive
Services Guidelines were originally established in 2011 based on a
study and recommendations by the Institute of Medicine, now known as
the National Academy of Medicine, commissioned by HHS. Since then,
there have been advancements in science and gaps identified in these
guidelines, including a greater emphasis on practice-based clinical
considerations. In March 2016, HRSA awarded a 5-year cooperative
agreement to convene a coalition representing clinicians, academics,
and consumer-focused health professional organizations to conduct a
rigorous review of current scientific evidence and recommend updates to
existing guidelines. The ACOG was awarded the cooperative agreement and
formed the WPSI, which consists of an Advisory Panel and two expert
committees; the Multidisciplinary Steering Committee (MSC) and the
Dissemination and Implementation Steering Committee, to improve adult
women's health across the lifespan by engaging a coalition of health
professional organizations to review evidence and recommend updates to
the HRSA-supported Women's Preventive Services Guidelines. HRSA would
then decide whether or not to support, in whole or
[[Page 46857]]
in part, the recommended updates to the Guidelines.
In March 2021, ACOG was awarded a subsequent cooperative agreement
to further review and recommend updates to the Guidelines. As the award
recipient, starting on March 1, 2021, ACOG has engaged in a process to
consider and review new information developed by a multidisciplinary
group of women's health professional organizations. Following
recommendations by ACOG, HRSA will decide whether to support, in whole
or in part, the recommended updates to the guidelines.
As part of this cooperative agreement, ACOG is required to base its
recommended updates to the Guidelines on review and synthesis of
existing clinical guidelines and new scientific evidence. The National
Academy of Medicine standards for establishing foundations for and
rating strengths of recommendations, articulation of recommendations,
as well as external reviews are to be met in developing these
guidelines. Additionally, processes are to be incorporated to assure
opportunity for public input and transparency, including participation
by patients and consumers, in the development of the updated Guideline
recommendations.
This notice solicits comments from the public on the draft
recommendation statements for the Well-Woman Preventive Visits,
Counseling for Sexually Transmitted Infections, and Breastfeeding
Services and Supplies. The updated draft clinical recommendation
statements are provided below:
Well Woman Preventive Visits
The MSC has updated the clinical recommendation statement to
reflect that recommended services may be completed at a single visit or
as part of a series of preventive health visits that take place over
time to obtain the necessary services. Well Women Visits have also been
further defined to include pre-pregnancy, prenatal, and interpregnancy
visits.
``The WPSI recommends that women receive at least one preventive
care visit per year beginning in adolescence and continuing across
the lifespan to ensure the provision of all recommended preventive
services. These services may be completed at a single visit or as
part of a series of visits that take place over time to obtain all
necessary services depending on a woman's age, health status,
reproductive health needs, pregnancy status, and risk factors. Well
women visits include pre-pregnancy, prenatal, and interpregnancy
visits. The primary purpose of well-woman visits is the delivery and
coordination of all recommended preventive services as determined by
age and risk factors.''
Counseling for Sexually Transmitted Infections
The MSC has made minor updates to the counseling for sexually
transmitted infections statement to include a review of a women's
sexual history, and modified the risk factor list by stating that risk
factors are ``not limited to'' the areas indicated.
``The WPSI recommends directed behavioral counseling by a health
care provider or other appropriately trained individual for sexually
active adolescent and adult women at an increased risk for sexually
transmitted infections (STIs).
The WPSI recommends that health care providers review a woman's
sexual history and risk factors to help identify those at an
increased risk of STIs. Risk factors include but are not limited to
age younger than 25 years, a recent history of an STI, a new sex
partner, multiple partners, a partner with concurrent partners, a
partner with an STI, and a lack of or inconsistent condom use. For
adolescents and women not identified as high risk, counseling to
reduce the risk of STIs should be considered, as determined by
clinical judgment.''
Breastfeeding Services and Supplies
The MSC has updated the clinical recommendation to include
consultative services that will 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.''
Members of the public can view each complete updated draft
recommendation statement by accessing the initiative's web page at
https://www.womenspreventivehealth.org/.
Diana Espinosa,
Acting Administrator.
[FR Doc. 2021-17826 Filed 8-19-21; 8:45 am]
BILLING CODE 4165-15-P