Update to the Women's Preventive Services Guidelines, 722-723 [2020-00035]
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Federal Register / Vol. 85, No. 4 / Tuesday, January 7, 2020 / Notices
deemed products, prior to May 12, 2020,
or during the one-year review period.
Since issuing the August 2017
Compliance Policy, FDA has received
information underscoring the problem
of youth use of ENDS products, as well
as evidence of other new and continued
public health concerns related to ENDS
products. For example, data from the
2018 National Youth Tobacco Survey
(NYTS), as described throughout the
guidance, documented a significant
increase in youth use of ENDS products
and revealed the magnitude of the
problem. These data prompted FDA to
issue a draft guidance regarding the
continued marketing of deemed tobacco
products that had not obtained
premarket authorization, and to call on
industry to do more to keep their
products out of the hands of minors. In
March 2019, FDA published a draft
guidance entitled ‘‘Modifications to
Compliance Policy for Certain Deemed
Tobacco Products’’ (‘‘March 2019 Draft
Guidance’’), which discussed the
Agency’s plan to modify the August
2017 Compliance Policy and prioritize
enforcement of the premarket
authorization requirements for certain
deemed tobacco products.
Recent data show a second
consecutive year with an alarming
increase in youth use of ENDS products.
In 2019, two of the largest surveys of
tobacco use among youth found that ecigarette use has reached the highest
levels ever recorded. The 2019
Monitoring the Future Study shows that
e-cigarette use among 8th, 10th, and
12th graders who had used ENDS
products during the previous 12 months
and those who had ever used ENDS
products significantly increased from
2018 to 2019. Data from the 2019 NYTS
also show that 2019 was the second
consecutive year in which current (past
30-day) e-cigarette use among youth
reached unprecedented levels. Evidence
from the 2016–2017 (Wave 4)
Population Assessment of Tobacco and
Health Study and other studies, as
described in the guidance, further
confirms these trends, including that
youth are particularly attracted to
flavored ENDS products.
Moreover, recent data indicate that
youth overwhelmingly prefer cartridgebased ENDS products, which FDA has
found are easy to conceal, can be used
discreetly, may have a high nicotine
content, and are manufactured on a
large scale. The 2019 NYTS survey
instrument included a measure for the
‘‘usual brand’’ of e-cigarette used in the
past 30 days, and the majority of youth
who were current e-cigarette users
reported a cartridge-based e-cigarette as
their usual brand.
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Finally, FDA remains concerned
about health and safety issues
connected to ENDS products—e.g.,
cases of lung injuries associated with
use of vaping products as well as battery
explosions with ENDS products—
particularly given that all of these
products have been marketed without
premarket authorization. These current
public health issues affirm the
importance of the premarket review
process, as contemplated by the
Tobacco Control Act, to scientifically
evaluate products based on a public
health standard. For example, FDA
review of premarket tobacco product
applications considers the risks and
benefits of the product to the population
as a whole, including tobacco product
users and non-users. In reviewing
premarket tobacco product applications,
FDA will consider, among other things:
The product’s components, ingredients,
additives, and properties;
manufacturing practices; and any
studies or investigations into the health
risks of the tobacco product.
The Agency views the dramatic
increase in youth use of these products
as a problem that requires an urgent
response. Accordingly, FDA is issuing
this final guidance to communicate its
enforcement priorities with respect to
ENDS products. FDA would adopt these
enforcement priorities for ENDS
regardless of the decision of the U.S.
District Court for the District of
Maryland in American Academy of
Pediatrics, et al. v. Food and Drug
Administration, et al.3 Additionally, as
described in the guidance, consistent
with the court’s order, manufacturers of
other deemed new tobacco products
will be required to submit marketing
applications for those products by May
12, 2020.4
II. Significance of Guidance
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of the Agency’s enforcement
priorities for premarket review
requirements for certain deemed
tobacco products and describes how the
Agency intends to prioritize its
enforcement resources with regard to
the marketing of certain deemed tobacco
products that do not have premarket
authorization. It does not establish any
rights for any person and is not binding
3 American Academy of Pediatrics, et al. v. Food
and Drug Administration, et al., 379 F. Supp. 3d
461, 496 (D. Md. 2019).
4 American Academy of Pediatrics, et al. v. Food
and Drug Administration, et al., No. 8:18–cv–883
(PWG), 2019 WL 3067492, at *7 (D. Md. July 12,
2019) (Dkt. No. 127).
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on FDA or the public. You can use an
alternative approach if it satisfies the
requirements of the applicable statutes
and regulations.
III. Paperwork Reduction Act of 1995
This final guidance refers to
previously approved collections of
information found in FDA regulations.
These collections of information are
subject to review by the Office of
Management and Budget (OMB) under
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501–3521). The collections
of information in 21 CFR 1107.1(b) and
(c) have been approved under OMB
control number 0910–0684; the
collections of information under section
910 of the FD&C Act have been
approved under OMB control number
0910–0768. The collections of
information in section 905(j) of the
FD&C Act (21 U.S.C. 387e(j)) have been
approved under OMB control number
0910–0673.
IV. Electronic Access
Persons with access to the internet
may obtain an electronic version of the
guidance at either https://
www.regulations.gov or https://
www.fda.gov/tobacco-products/
products-guidance-regulations/rulesregulations-and-guidance.
Dated: December 31, 2019.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2019–28539 Filed 1–3–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Update to the Women’s Preventive
Services Guidelines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
On December 17, 2019, HRSA
approved an update to the HRSAsupported Women’s Preventive Services
Guidelines (Guidelines) that addresses
health needs specific to women. The
Guidelines are based on clinical
recommendations from the Women’s
Preventive Services Initiative.
Preventive care and screenings for
women provided for in comprehensive
guidelines supported by HRSA are
required to be covered without costsharing by non-grandfathered group
health plans and health insurance
SUMMARY:
E:\FR\FM\07JAN1.SGM
07JAN1
Federal Register / Vol. 85, No. 4 / Tuesday, January 7, 2020 / Notices
issuers offering non-grandfathered
group or individual health insurance
coverage. This 2019 update adds one
additional service—Screening for
Anxiety—to the HRSA-supported
Women’s Preventive Services
Guidelines to the 11 preventive services
that were last updated in 2017. The 11
services included in the 2017 update
are: Breast Cancer Screening for Average
Risk Women, Breastfeeding Services
and Supplies, Screening for Cervical
Cancer, Contraception, Screening for
Gestational Diabetes Mellitus, Screening
for Human Immunodeficiency Virus
Infection, Screening for Interpersonal
and Domestic Violence, Counseling for
Sexually Transmitted Infections, WellWoman Preventive Visits, Screening for
Diabetes Mellitus after Pregnancy, and
Screening for Urinary Incontinence.
This notice serves as an announcement
of the decision to update the guidelines
as listed below. Please see https://
www.hrsa.gov/womens-guidelines/
index.html for additional information.
FOR FURTHER INFORMATION CONTACT: Ada
Determan, Maternal and Child Health
Bureau at email: wellwomancare@
hrsa.gov or (301) 945–3057.
SUPPLEMENTARY INFORMATION: The
updated 2019 HRSA-supported
Women’s Preventive Services
Guidelines and information related to
guideline development and
implementation can be found on https://
www.hrsa.gov/womens-guidelines-2019/
index.html. Information regarding the
new preventive service approved by the
HRSA Administrator for inclusion in
the comprehensive guidelines is set out
below:
Screening for Anxiety
khammond on DSKJM1Z7X2PROD with NOTICES
The Women’s Preventive Services
Initiative recommends screening for
anxiety in adolescent and adult women,
including those who are pregnant or
postpartum. Optimal screening intervals
are unknown and clinical judgement
should be used to determine screening
frequency. Given the high prevalence of
anxiety disorders, lack of recognition in
clinical practice, and multiple problems
associated with untreated anxiety,
clinicians should consider screening
women who have not been recently
screened.
HRSA-Supported Women’s Preventive
Services Guidelines
The HRSA-supported Women’s
Preventive Services Guidelines were
originally established in 2011 based on
recommendations from the Institute of
Medicine, now known as the National
Academy of Medicine (NAM),
developed under a contract with HHS.
VerDate Sep<11>2014
16:15 Jan 06, 2020
Jkt 250001
Since then, there have been
advancements in science and gaps
identified in the existing guidelines,
including a greater emphasis on
practice-based clinical considerations.
To address these, HRSA awarded a 5year cooperative agreement in March
2016 to convene a coalition of clinician,
academic, and consumer-focused health
professional organizations and conduct
a scientifically rigorous review to
develop recommendations for updated
Women’s Preventive Services
Guidelines in accordance with the
model created by the NAM Clinical
Practice Guidelines We Can Trust. The
American College of Obstetricians and
Gynecologists was awarded the
cooperative agreement and formed an
expert panel called the Women’s
Preventive Services Initiative to perform
this work.
Under section 2713 of the Public
Health Service Act, 42 U.S.C. 300gg–13,
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 (generally
plans or policies created or sold after
March 23, 2010, or older plans or
policies that have been changed in
certain ways since that date) are
required to provide coverage without
cost sharing for preventive services
listed in the updated HRSA-supported
guidelines (which include the 11
preventive services last updated in 2017
as well as the one new service added in
this update) beginning with the first
plan year (in the individual market,
policy year) that begins on or after
December 17, 2020.
Dated: December 30, 2019.
Thomas J. Engels,
Administrator.
[FR Doc. 2020–00035 Filed 1–6–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
PO 00000
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723
Findings of research
misconduct have been made against
Alexander Neumeister, M.D.
(Respondent), who was a Professor of
Psychiatry and Radiology, Department
of Psychiatry, New York University
School of Medicine, Langone Medical
Center (NYUSOM). Dr. Neumeister
engaged in research misconduct in
psychiatric clinical research supported
by National Institute of Mental Health
(NIMH), National Institutes of Health
(NIH), grants R01 MH096876, R01
MH102566, R21 MH094763, R21
MH096105, R21 MH102035, and R34
MH102871. The administrative actions,
including debarment for a period of two
(2) years, followed by supervision for a
period of two (2) years, were
implemented beginning on December
13, 2019, and are detailed below.
FOR FURTHER INFORMATION CONTACT:
Elisabeth A. Handley, Interim Director,
Office of Research Integrity, 1101
Wootton Parkway, Suite 240, Rockville,
MD 20852, (240) 453–8200.
SUPPLEMENTARY INFORMATION: Notice is
hereby given that the Office of Research
Integrity (ORI) has taken final action in
the following case:
Alexander Neumeister, M.D., New
York University School of Medicine,
Langone Medical Center: Based on the
report of an investigation conducted by
NYUSOM and additional analysis
conducted by ORI in its oversight
review, ORI found that Dr. Alexander
Neumeister, Professor of Psychiatry and
Radiology, Department of Psychiatry,
NYUSOM, engaged in research
misconduct in psychiatric clinical
research supported by NIMH, NIH,
grants R01 MH096876, R01 MH102566,
R21 MH094763, R21 MH096105, R21
MH102035, and R34 MH102871.
Respondent neither admits nor denies
ORI’s findings of research misconduct.
The settlement is not an admission of
liability on the part of the Respondent.
The parties entered into a Voluntary
Exclusion Agreement (Agreement) to
conclude this matter without further
expenditure of time, finances, or other
resources.
ORI found that Respondent engaged
in research misconduct by intentionally,
knowingly, and/or recklessly falsifying
and/or fabricating data in the clinical
records of research supported by six (6)
NIMH grants, resulting in the inclusion
of falsified and/or fabricated research
methods and results in four (4)
published papers:
• Association of in vivo k-opioid
receptor availability and the
transdiagnostic dimensional expression
of trauma-related psychopathology.
JAMA Psychiatry 2014
SUMMARY:
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[Federal Register Volume 85, Number 4 (Tuesday, January 7, 2020)]
[Notices]
[Pages 722-723]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00035]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Update to the Women's Preventive Services Guidelines
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: On December 17, 2019, HRSA approved an update to the HRSA-
supported Women's Preventive Services Guidelines (Guidelines) that
addresses health needs specific to women. The Guidelines are based on
clinical recommendations from the Women's Preventive Services
Initiative. Preventive care and screenings for women provided for in
comprehensive guidelines supported by HRSA are required to be covered
without cost-sharing by non-grandfathered group health plans and health
insurance
[[Page 723]]
issuers offering non-grandfathered group or individual health insurance
coverage. This 2019 update adds one additional service--Screening for
Anxiety--to the HRSA-supported Women's Preventive Services Guidelines
to the 11 preventive services that were last updated in 2017. The 11
services included in the 2017 update are: Breast Cancer Screening for
Average Risk Women, Breastfeeding Services and Supplies, Screening for
Cervical Cancer, Contraception, Screening for Gestational Diabetes
Mellitus, Screening for Human Immunodeficiency Virus Infection,
Screening for Interpersonal and Domestic Violence, Counseling for
Sexually Transmitted Infections, Well-Woman Preventive Visits,
Screening for Diabetes Mellitus after Pregnancy, and Screening for
Urinary Incontinence. This notice serves as an announcement of the
decision to update the guidelines as listed below. Please see https://www.hrsa.gov/womens-guidelines/ for additional information.
FOR FURTHER INFORMATION CONTACT: Ada Determan, Maternal and Child
Health Bureau at email: [email protected] or (301) 945-3057.
SUPPLEMENTARY INFORMATION: The updated 2019 HRSA-supported Women's
Preventive Services Guidelines and information related to guideline
development and implementation can be found on https://www.hrsa.gov/womens-guidelines-2019/. Information regarding the new
preventive service approved by the HRSA Administrator for inclusion in
the comprehensive guidelines is set out below:
Screening for Anxiety
The Women's Preventive Services Initiative recommends screening for
anxiety in adolescent and adult women, including those who are pregnant
or postpartum. Optimal screening intervals are unknown and clinical
judgement should be used to determine screening frequency. Given the
high prevalence of anxiety disorders, lack of recognition in clinical
practice, and multiple problems associated with untreated anxiety,
clinicians should consider screening women who have not been recently
screened.
HRSA-Supported Women's Preventive Services Guidelines
The HRSA-supported Women's Preventive Services Guidelines were
originally established in 2011 based on recommendations from the
Institute of Medicine, now known as the National Academy of Medicine
(NAM), developed under a contract with HHS. Since then, there have been
advancements in science and gaps identified in the existing guidelines,
including a greater emphasis on practice-based clinical considerations.
To address these, HRSA awarded a 5-year cooperative agreement in March
2016 to convene a coalition of clinician, academic, and consumer-
focused health professional organizations and conduct a scientifically
rigorous review to develop recommendations for updated Women's
Preventive Services Guidelines in accordance with the model created by
the NAM Clinical Practice Guidelines We Can Trust. The American College
of Obstetricians and Gynecologists was awarded the cooperative
agreement and formed an expert panel called the Women's Preventive
Services Initiative to perform this work.
Under section 2713 of the Public Health Service Act, 42 U.S.C.
300gg-13, 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 (generally plans or policies created or
sold after March 23, 2010, or older plans or policies that have been
changed in certain ways since that date) are required to provide
coverage without cost sharing for preventive services listed in the
updated HRSA-supported guidelines (which include the 11 preventive
services last updated in 2017 as well as the one new service added in
this update) beginning with the first plan year (in the individual
market, policy year) that begins on or after December 17, 2020.
Dated: December 30, 2019.
Thomas J. Engels,
Administrator.
[FR Doc. 2020-00035 Filed 1-6-20; 8:45 am]
BILLING CODE 4165-15-P
