Request for Comments on Draft Recommendation Statement on Preventing Obesity in Midlife Women, as Part of the HRSA-Supported Women's Preventive Services Guidelines, 71350-71351 [2020-24819]
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Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices
stakeholders (e.g., physicians,
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Several comments were submitted
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reconstituting, or other such acts that
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directions contained in FDA-approved
labeling; adding a footnote to reflect that
the FDA does not generally object to
rapid movement temporary blocking or
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when necessary for the safe handling of
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language in a footnote concerning the
scope of physician compounding or
repackaging activities to state that FDA
generally does not intend to take action
under section 501(a)(2)(A) of the FD&C
Act against a physician who is
compounding a drug product,
repackaging an FDA-approved drug
product, or who is mixing, diluting, or
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administration to the physician’s
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encouraging compounders to use risk
evaluation strategies and risk
management tools to develop
appropriate controls necessary to
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conditions at their facilities. In addition,
editorial changes were made to the
guidance for clarity.
This guidance is being issued
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The guidance represents the current
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Conditions at Compounding Facilities.’’
The examples described in the final
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does not establish any rights for any
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II. Paperwork Reduction Act of 1995
This guidance contains no collection
of information. Therefore, clearance by
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(OMB) under the Paperwork Reduction
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Jkt 253001
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required.
However, this guidance refers to a
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III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm or https://
www.regulations.gov.
Dated: November 3, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–24807 Filed 11–6–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Request for Comments on Draft
Recommendation Statement on
Preventing Obesity in Midlife Women,
as Part of the HRSA-Supported
Women’s Preventive Services
Guidelines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
This notice seeks public
comments on a draft recommendation
statement on preventing obesity in
midlife women, as part of the HRSAsupported Women’s Preventive Services
Guidelines (‘‘Guidelines’’), through a
national cooperative agreement, the
Women’s Preventive Services Initiative
(WPSI). The WPSI recommends
counseling midlife women, aged 40 to
60 years, with normal or overweight
BMI (18.5–29.9 kg/m2) to maintain
weight or limit weight gain to prevent
obesity. Counseling may include
individualized discussion of healthy
eating and physical activity. Under
Section 2713 of 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
SUMMARY:
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under that section, including those
provided for in the Guidelines.
DATES: Members of the public are
invited to provide written comments no
later than December 9, 2020. All
comments received on or before this
date will be reviewed and considered by
the WPSI Multidisciplinary Steering
Committee, and provided to HRSA for
further consideration in determining the
recommended updates that it will
support.
Members of the public
interested in providing comments can
do so by accessing the initiative’s web
page at https://www.womenspreventive
health.org/.
FOR FURTHER INFORMATION CONTACT:
Kimberly Sherman, HRSA, Maternal
and Child Health Bureau, telephone
(301) 443–8283 or email:
wellwomancare@hrsa.gov.
SUPPLEMENTARY INFORMATION: The
HRSA-supported Women’s Preventive
Services Guidelines were originally
established in 2011 based on
recommendations from an HHS
commissioned study by the Institute of
Medicine, now known as the National
Academy of Medicine (NAM). Since
then, there have been advancements in
science and gaps identified in the
existing guidelines, including a greater
emphasis on practice-based clinical
considerations. HRSA awarded a 5-year
cooperative agreement in March 2016
(HRSA–16–057) 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, in accordance with the
framework created by the NAM Clinical
Practice Guidelines We Can Trust expert
committee. The American College of
Obstetricians and Gynecologists was
awarded the cooperative agreement and
formed an expert panel called the
Women’s Preventive Services Initiative.
Under section 2713 of the Public
Health Service Act, non-grandfathered
group health plans and issuers of nongrandfathered group and individual
health insurance coverage are required
to cover specified preventive services
without a copayment, coinsurance,
deductible, or other cost sharing,
including preventive care and
screenings for women as provided for in
comprehensive guidelines supported by
HRSA for this purpose. Nongrandfathered group health plans and
health insurance issuers offering nongrandfathered group or individual
coverage are required to provide
coverage without cost sharing for
ADDRESSES:
E:\FR\FM\09NON1.SGM
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Federal Register / Vol. 85, No. 217 / Monday, November 9, 2020 / Notices
preventive services listed in the updated
HRSA-supported Guidelines.
Under HRSA’s cooperative agreement
with the American College of
Obstetricians and Gynecologists, the
WPSI administers processes which
assure public input and transparency, as
well as participation by patient and
consumer representatives, in the
development of these Guidelines.
Thomas J. Engels,
Administrator.
[FR Doc. 2020–24819 Filed 11–6–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Advisory Council on Alzheimer’s
Research, Care, and Services; Meeting
Assistant Secretary for
Planning and Evaluation, HHS.
ACTION: Notice of meeting.
AGENCY:
This notice announces the
public meeting of the Advisory Council
on Alzheimer’s Research, Care, and
Services (Advisory Council). The
Advisory Council provides advice on
how to prevent or reduce the burden of
Alzheimer’s disease and related
dementias on people with the disease
and their caregivers. The Advisory
Council will next meet on Monday,
November 9, and Tuesday, November
10. On November 9, federal
representatives will provide updates on
efforts to address Alzheimer’s disease
since January and a panel will present
the results of two VA programs, STAR–
VA and REACH–VA. On November 10,
an invited panel will discuss past and
current initiatives to expand access to
long-term services and supports.
DATES: The meeting will be held on
November 9 from 1:00 p.m. to 4:00 p.m.
EST and November 10 from 1:00 p.m. to
4:00 p.m. EST.
ADDRESSES: The meeting will be virtual
and stream live at https://www.hhs.gov/
live.
Comments: Time is allocated on the
agenda to hear public comments from
3:30 p.m. to 4:00 p.m. The time for oral
comments will be limited to two (2)
minutes per individual. In order to
provide a public comment, please
register by emailing your name to
napa@hhs.gov by Thursday, November
5. Registered commenters will receive
both a dial-in number and a link to join
the meeting virtually; individuals will
have the choice to either join virtually
via the link, or to call in only by using
the dial-in number. Note: There may be
a 30–45 second delay in the livestream
khammond on DSKJM1Z7X2PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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Jkt 253001
video presentation of the conference.
For this reason, if you have preregistered to submit a public comment,
it is important to connect to the meeting
by 3:15 p.m. to ensure that you do not
miss your name and allotted time when
called. If you miss your name and
allotted time to speak, you may not be
able to make your public comment. All
participant audio lines will be muted for
the duration of the meeting and only
unmuted by the Host at the time of the
participant’s public comment. Should
you have questions during the session
email napa@hhs.gov and someone will
respond to your message as quickly as
possible.
In order to ensure accuracy, please
submit a written copy of oral comments
for the record by emailing napa@
hhs.gov by Thursday, November 12.
These comments will be shared on the
website and reflected in the meeting
minutes.
In lieu of oral comments, formal
written comments may be submitted for
the record by Tuesday, November 10 to
Helen Lamont, Ph.D., OASPE, 200
Independence Avenue SW, Room 424E,
Washington, DC 20201. Comments may
also be sent to napa@hhs.gov. Those
submitting written comments should
identify themselves and any relevant
organizational affiliations.
FOR FURTHER INFORMATION CONTACT:
Helen Lamont, 202–260–6075,
helen.lamont@hhs.gov. Note: The
meeting will be available to the public
live at www.hhs.gov/live.
Notice of
these meetings is given under the
Federal Advisory Committee Act (5
U.S.C. App. 2, section 10(a)(1) and
(a)(2)). Topics of the Meeting: An
invited panel will present on emergency
preparedness for people with dementia
with a special focus on the COVID–19
pandemic. The chairs of the
subcommittees (Research, Clinical Care,
and Long-Term Services and Supports)
will present recommendations for
adoption by the full Advisory Council.
Procedure and Agenda: The meeting
will be webcast at www.hhs.gov/live and
video recordings will be added to the
National Alzheimer’s Project Act
website when available, after the
meeting.
SUPPLEMENTARY INFORMATION:
Authority: 42 U.S.C. 11225; Section 2(e)(3)
of the National Alzheimer’s Project Act. The
panel is governed by provisions of Public
Law 92–463, as amended (5 U.S.C. Appendix
2), which sets forth standards for the
formation and use of advisory committees.
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71351
Dated: October 13, 2020.
Brenda Destro,
Deputy Assistant Secretary for Planning and
Evaluation, Office of Human Services Policy.
[FR Doc. 2020–24818 Filed 11–6–20; 8:45 am]
BILLING CODE 4150–05–P
DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2020–0033; OMB No.
1660–0026]
Agency Information Collection
Activities: Proposed Collection;
Comment Request; State
Administrative Plan for the Hazard
Mitigation Grant Program
Federal Emergency
Management Agency, DHS.
ACTION: 60 day notice and request for
comments.
AGENCY:
The Federal Emergency
Management Agency, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the
general public to take this opportunity
to comment on an extension, without
change, of a currently approved
information collection. In accordance
with the Paperwork Reduction Act of
1995, this notice seeks comments
concerning the State Administrative
Plan for the procedural guide that
details how the State will administer the
Hazard Mitigation Grant Program
(HMGP).
SUMMARY:
Comments must be submitted on
or before January 8, 2021.
ADDRESSES: Submit comments at
www.regulations.gov under Docket ID
FEMA–2020–0033. Follow the
instructions for submitting comments.
All submissions received must
include the agency name and Docket ID,
and will be posted, without change, to
the Federal eRulemaking Portal at
https://www.regulations.gov, and will
include any personal information you
provide. Therefore, submitting this
information makes it public. You may
wish to read the Privacy and Security
Notice that is available via a link on the
homepage of www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Roselyn Brown-Frei, Section Chief,
Hazard Mitigation Division, Federal
Insurance and Mitigation
Administration, FEMA, roselyn.brownfrei@fema.dhs.gov, 202–924–7198. You
may contact the Information
Management Division for copies of the
proposed collection of information at
DATES:
E:\FR\FM\09NON1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 217 (Monday, November 9, 2020)]
[Notices]
[Pages 71350-71351]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-24819]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Request for Comments on Draft Recommendation Statement on
Preventing Obesity in Midlife Women, as Part of the HRSA-Supported
Women's Preventive Services Guidelines
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice seeks public comments on a draft recommendation
statement on preventing obesity in midlife women, as part of the HRSA-
supported Women's Preventive Services Guidelines (``Guidelines''),
through a national cooperative agreement, the Women's Preventive
Services Initiative (WPSI). The WPSI recommends counseling midlife
women, aged 40 to 60 years, with normal or overweight BMI (18.5-29.9
kg/m2) to maintain weight or limit weight gain to prevent obesity.
Counseling may include individualized discussion of healthy eating and
physical activity. Under Section 2713 of 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 Guidelines.
DATES: Members of the public are invited to provide written comments no
later than December 9, 2020. All comments received on or before this
date will be reviewed and considered by the WPSI Multidisciplinary
Steering Committee, and provided to HRSA for further consideration in
determining the recommended updates that it will support.
ADDRESSES: Members of the public interested in providing comments 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 or email:
[email protected].
SUPPLEMENTARY INFORMATION: The HRSA-supported Women's Preventive
Services Guidelines were originally established in 2011 based on
recommendations from an HHS commissioned study by the Institute of
Medicine, now known as the National Academy of Medicine (NAM). Since
then, there have been advancements in science and gaps identified in
the existing guidelines, including a greater emphasis on practice-based
clinical considerations. HRSA awarded a 5-year cooperative agreement in
March 2016 (HRSA-16-057) 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, in accordance
with the framework created by the NAM Clinical Practice Guidelines We
Can Trust expert committee. The American College of Obstetricians and
Gynecologists was awarded the cooperative agreement and formed an
expert panel called the Women's Preventive Services Initiative.
Under section 2713 of the Public Health Service Act, non-
grandfathered group health plans and issuers of non-grandfathered group
and individual health insurance coverage are required to cover
specified preventive services without a copayment, coinsurance,
deductible, or other cost sharing, including preventive care and
screenings for women as provided for in comprehensive guidelines
supported by HRSA for this purpose. Non-grandfathered group health
plans and health insurance issuers offering non-grandfathered group or
individual coverage are required to provide coverage without cost
sharing for
[[Page 71351]]
preventive services listed in the updated HRSA-supported Guidelines.
Under HRSA's cooperative agreement with the American College of
Obstetricians and Gynecologists, the WPSI administers processes which
assure public input and transparency, as well as participation by
patient and consumer representatives, in the development of these
Guidelines.
Thomas J. Engels,
Administrator.
[FR Doc. 2020-24819 Filed 11-6-20; 8:45 am]
BILLING CODE 4165-15-P
