Supplemental Evidence and Data Request on Genitourinary Syndrome of Menopause, 14616-14618 [2023-04800]
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Federal Register / Vol. 88, No. 46 / Thursday, March 9, 2023 / Notices
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[FR Doc. 2023–04781 Filed 3–8–23; 8:45 am]
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Michele Taylor Fennell,
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[FR Doc. 2023–04779 Filed 3–8–23; 8:45 am]
BILLING CODE P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Agency for Healthcare Research and
Quality
Supplemental Evidence and Data
Request on Genitourinary Syndrome of
Menopause
Agency for Healthcare Research
and Quality (AHRQ), HHS.
ACTION: Request for supplemental
evidence and data submissions.
AGENCY:
FEDERAL RESERVE SYSTEM
ddrumheller on DSK120RN23PROD with NOTICES1
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of the Act (12 U.S.C. 1817(j)(7)).
The public portions of the
applications listed below, as well as
other related filings required by the
Board, if any, are available for
immediate inspection at the Federal
VerDate Sep<11>2014
18:19 Mar 08, 2023
Jkt 259001
The Agency for Healthcare
Research and Quality (AHRQ) is seeking
scientific information submissions from
the public. Scientific information is
being solicited to inform our review on
Genitourinary Syndrome of Menopause,
which is currently being conducted by
the AHRQ’s Evidence-based Practice
Centers (EPC) Program. Access to
published and unpublished pertinent
scientific information will improve the
quality of this review.
DATES: Submission Deadline on or
before April 10, 2023.
ADDRESSES:
SUMMARY:
PO 00000
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Email submissions: epc@
ahrq.hhs.gov.
Print submissions:
Mailing Address: Center for Evidence
and Practice Improvement, Agency for
Healthcare Research and Quality,
ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A,
Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.):
Center for Evidence and Practice
Improvement, Agency for Healthcare
Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers
Lane, Mail Stop 06E77D, Rockville,
MD 20857
FOR FURTHER INFORMATION CONTACT:
Jenae Benns, Telephone: 301–427–1496
or Email: epc@ahrq.hhs.gov.
SUPPLEMENTARY INFORMATION: The
Agency for Healthcare Research and
Quality has commissioned the
Evidence-based Practice Centers (EPC)
Program to complete a review of the
evidence for Genitourinary Syndrome of
Menopause. AHRQ is conducting this
systematic review pursuant to Section
902 of the Public Health Service Act, 42
U.S.C. 299a.
The EPC Program is dedicated to
identifying as many studies as possible
that are relevant to the questions for
each of its reviews. In order to do so, we
are supplementing the usual manual
and electronic database searches of the
literature by requesting information
from the public (e.g., details of studies
conducted). We are looking for studies
that report on Genitourinary Syndrome
of Menopause, including those that
describe adverse events. The entire
research protocol is available online at:
https://effectivehealthcare.ahrq.gov/
products/genitourinary-syndrome/
protocol.
This is to notify the public that the
EPC Program would find the following
information on Genitourinary Syndrome
of Menopause helpful:
D A list of completed studies that
your organization has sponsored for this
indication. In the list, please indicate
whether results are available on
ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
D For completed studies that do not
have results on ClinicalTrials.gov, a
summary, including the following
elements: study number, study period,
design, methodology, indication and
diagnosis, proper use instructions,
inclusion and exclusion criteria,
primary and secondary outcomes,
baseline characteristics, number of
patients screened/eligible/enrolled/lost
to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
E:\FR\FM\09MRN1.SGM
09MRN1
14617
Federal Register / Vol. 88, No. 46 / Thursday, March 9, 2023 / Notices
D A list of ongoing studies that your
organization has sponsored for this
indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the
trial is not registered, the protocol for
the study including a study number, the
study period, design, methodology,
indication and diagnosis, proper use
instructions, inclusion and exclusion
criteria, and primary and secondary
outcomes.
D Description of whether the above
studies constitute ALL Phase II and
above clinical trials sponsored by your
organization for this indication and an
index outlining the relevant information
in each submitted file.
Your contribution is very beneficial to
the Program. Materials submitted must
be publicly available or able to be made
public. Materials that are considered
confidential; marketing materials; study
types not included in the review; or
information on indications not included
in the review cannot be used by the EPC
Program. This is a voluntary request for
information, and all costs for complying
with this request must be borne by the
submitter.
The draft of this review will be posted
on AHRQ’s EPC Program website and
available for public comment for a
period of 4 weeks. If you would like to
be notified when the draft is posted,
please sign up for the email list at:
https://
www.effectivehealthcare.ahrq.gov/
email-updates.
The systematic review will answer the
following questions. This information is
provided as background. AHRQ is not
requesting that the public provide
answers to these questions.
Key Questions (KQ)
KQ 1: What is the effectiveness and
harms of screening strategies to identify
GSM in postmenopausal women? Does
screening impact patient reported
symptoms or improve quality of life?
KQ 2: What is the effectiveness and
comparative effectiveness of hormonal,
non-hormonal, and energy-based
interventions when used alone or in
combination for treatment of GSM
symptoms? Which treatments show
improvement for which symptoms?
KQ 3: What are the harms (and
comparative harms) of hormonal, nonhormonal, and energy-based
interventions for GSM symptoms?
KQ 4: What is the appropriate followup interval to assess improvement,
sustained improvement, or regression of
symptoms of GSM in women treated
with hormonal, non-hormonal, and
energy-based interventions?
KQ 5: What is the effectiveness,
comparative effectiveness, and harms of
endometrial surveillance among women
who have a uterus and are using
hormonal therapy for GSM?
POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN (PICOTS)
Inclusion
Population:
KQ1: ................
KQ2–4: ............
KQ5: ................
Interventions:
KQ1: ................
KQ2–4: ............
KQ5: ................
Comparison:
KQ1: ................
KQ2–4: ............
ddrumheller on DSK120RN23PROD with NOTICES1
KQ5: ................
Outcomes:
KQ1: ................
KQ 1, 2&4 ...............
VerDate Sep<11>2014
Exclusion
Postmenopausal women.
Postmenopausal women, premenopausal women in hypoestrogenic state, or gender diverse individuals on hormonal therapy, with one or more symptom of GSM.
Patients with a uterus using hormonal therapy primarily for GSM symptoms ................................
Screening evaluations and/or questionnaires ..................................................................................
Hormonal Interventions: Systemic estrogen for GSM, vaginal estrogen therapy, including vaginal cream, tablets, inserts or ring, selective estrogen receptor modulator (SERM),
intravaginal dehydroepiandrosterone (DHEA), vaginal testosterone, compounded and bioidentical hormonal therapies; phytoestrogens.
Energy-based interventions: CO2 laser, Erbium: YAG, radio-frequency laser ...............................
Non-hormonal interventions: Over-the-counter non-hormone vaginal lubricants and moisturizers,
hyaluronic acid, herbal therapies/supplemental alternatives, vitamin D, vitamin E, probiotics,
oxytocin vaginal gel, pelvic floor physical therapy to treat vaginal or sexual symptoms of GSM.
For KQ4. Assess different durations of follow-up.
Individuals with genitourinary symptoms for
reasons other than
GSM.
Patients using hormonal therapy for
reasons other than
GSM.
Physical exam.
Menopausal hormone
therapy only for reasons other than
GSM.
Laser therapy for anatomic areas other
than the vagina.
Pelvic floor physical
therapy for urinary incontinence.
Endometrial surveillance with ultrasound or biopsy.
Usual care.
Effectiveness: Placebo, inactive control, sham.
Comparative Effectiveness: Another hormonal, non-hormonal, or energy-based intervention.
For KQ4. Assess different durations of follow up.
Usual care, or different type or level of surveillance.
Diagnosis of GSM, potential harms: misdiagnosis as another condition with similar presentation
such as inflammatory dermatologic conditions, malignancy, infections, or presence of symptoms prior to menopause. Progressing to unnecessary diagnostics for the index patient such
as vaginal or endometrial biopsy.
Change in symptoms: ......................................................................................................................
Genitourinary symptoms: urinary frequency, urinary urgency, nocturia, dysuria, recurrent urinary
tract infections.
Other urinary symptoms (outcomes evaluated for interventions other than PFMT): urinary urge
incontinence, overactive bladder.
Genital signs and symptoms: urethral caruncle, urethral prolapse, vaginal atrophy or atrophic
vaginitis, vaginal dryness, vaginal/vulvar irritation, vaginal soreness, vaginal lubrication, vaginal pain.
Sexual symptoms: dyspareunia, orgasmic dysfunction, low libido, decreased arousal, sexual desire, sexual function, bleeding associated with sexual activity.
18:19 Mar 08, 2023
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Serum hormone concentration, Stress incontinence.
14618
Federal Register / Vol. 88, No. 46 / Thursday, March 9, 2023 / Notices
POPULATION, INTERVENTION, COMPARATOR, OUTCOME, TIMING, SETTING/STUDY DESIGN (PICOTS)—Continued
Inclusion
KQ3&5: ............
Timing:
All KQ ..............
Setting:
All KQ ..............
Study design:
KQ1 .................
KQ2 .................
KQ3 .................
KQ4 .................
KQ5 .................
Language ................
Geographic Location.
Study size ...............
Publication date ......
Exclusion
Psychological symptoms: depression, anxiety, quality of life, partner satisfaction.
Safety outcomes: breast cancer, breast cancer recurrence or progression, breast tenderness,
cardiovascular risk, endometrial cancer (KQ5), post-menopausal bleeding (KQ5), endometrial
hyperplasia (KQ5), endometrial thickness (KQ5).
Adverse events: worsening or onset of urinary, genital, or sexual symptoms: vaginal burning,
vaginal bleeding, vaginal discharge, vaginal scarring, vaginal stenosis; pelvic pain;
dyspareunia; urethral strictures; meatal stricture/stenosis..
Systemic adverse events: chronic pain, stroke; VTE (DVT or PE); death; hot flashes; headache;
breast pain; cramps; bloating; nausea; vomiting.
Intervention: any.
Outcomes: any.
Any.
RCTs and prospective observational studies with concurrent comparison group and analytic
techniques to control for sample selection bias; systematic reviews of these study designs
that assessed ROB of included studies using validated tools.
RCTs or systematic review of RCTs that assessed ROB of included studies using validated
tools.
RCTs and prospective observational studies with concurrent comparison group and analytic
techniques to control for sample selection bias; systematic reviews of these study designs
that assessed ROB of included studies using validated tools.
RCTs or systematic review of RCTs that assessed ROB of included studies using validated
tools.
RCTs and prospective observational studies with concurrent comparison group and analytic
techniques to control for sample selection bias; systematic reviews of these study designs
that assessed ROB of included studies using validated tools.
English only (due to resource limitations).
Any.
N = 20 or more participants analyzed per study arm for RCTs.
Any.
Abbreviations: CO2 = carbon dioxide; DHEA = dehydroepiandrosterone; DVT = deep venous thromboembolism; GSM = Genitourinary Syndrome of Menopause; KQ = key question; PE = pulmonary embolism; PFMT = pelvic floor muscle training; RCT = randomized controlled trial;
SERM = selective estrogen receptor modulator; VTE = venous thromboembolism.
Dated: March 3, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023–04800 Filed 3–8–23; 8:45 am]
BILLING CODE 4160–90–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[Docket No. 0970–0558]
Proposed Information Collection
Activity; Generic for Administration for
Children and Families Program
Monitoring Activities (Office of
Management and Budget)
Office of Planning, Research,
and Evaluation, Administration for
Children and Families, U.S. Department
of Health and Human Services.
ACTION: Request for public comments.
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
The Administration for
Children and Families (ACF) intends to
request from the Office of Management
and Budget (OMB) an extension of
SUMMARY:
VerDate Sep<11>2014
18:19 Mar 08, 2023
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approval for an umbrella generic
clearance for information collections
related to ACF program office
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Comments due within 60 days of
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of the information collection described
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DATES:
You can obtain copies of the
proposed collection of information and
submit comments by emailing
OPREinfocollection@acf.hhs.gov.
Identify all requests by the title of the
information collection.
ADDRESSES:
PO 00000
Frm 00026
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Sfmt 4703
SUPPLEMENTARY INFORMATION:
Description: Program monitoring is a
post-award process through which ACF
assesses a recipient’s programmatic
performance and business management
performance. Monitoring activities are
necessary to ensure timely action by
ACF to support grantees and protect
federal interests. Program offices use
information collected under this generic
clearance to monitor funding recipient
activities and to provide support or take
appropriate action, as needed. The
information gathered is or will be used
primarily for internal purposes, but
aggregate data may be included in
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Congress or program office documents.
Following standard OMB requirements,
ACF will submit a request for each
individual data collection activity under
this generic clearance. Each request will
include the individual form(s) or
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the individual information collection,
and any supplementary documents.
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Respondents: ACF funding recipients.
E:\FR\FM\09MRN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 46 (Thursday, March 9, 2023)]
[Notices]
[Pages 14616-14618]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-04800]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Agency for Healthcare Research and Quality
Supplemental Evidence and Data Request on Genitourinary Syndrome
of Menopause
AGENCY: Agency for Healthcare Research and Quality (AHRQ), HHS.
ACTION: Request for supplemental evidence and data submissions.
-----------------------------------------------------------------------
SUMMARY: The Agency for Healthcare Research and Quality (AHRQ) is
seeking scientific information submissions from the public. Scientific
information is being solicited to inform our review on Genitourinary
Syndrome of Menopause, which is currently being conducted by the AHRQ's
Evidence-based Practice Centers (EPC) Program. Access to published and
unpublished pertinent scientific information will improve the quality
of this review.
DATES: Submission Deadline on or before April 10, 2023.
ADDRESSES:
Email submissions: [email protected].
Print submissions:
Mailing Address: Center for Evidence and Practice Improvement, Agency
for Healthcare Research and Quality, ATTN: EPC SEADs Coordinator, 5600
Fishers Lane, Mail Stop 06E53A, Rockville, MD 20857
Shipping Address (FedEx, UPS, etc.): Center for Evidence and Practice
Improvement, Agency for Healthcare Research and Quality, ATTN: EPC
SEADs Coordinator, 5600 Fishers Lane, Mail Stop 06E77D, Rockville, MD
20857
FOR FURTHER INFORMATION CONTACT: Jenae Benns, Telephone: 301-427-1496
or Email: [email protected].
SUPPLEMENTARY INFORMATION: The Agency for Healthcare Research and
Quality has commissioned the Evidence-based Practice Centers (EPC)
Program to complete a review of the evidence for Genitourinary Syndrome
of Menopause. AHRQ is conducting this systematic review pursuant to
Section 902 of the Public Health Service Act, 42 U.S.C. 299a.
The EPC Program is dedicated to identifying as many studies as
possible that are relevant to the questions for each of its reviews. In
order to do so, we are supplementing the usual manual and electronic
database searches of the literature by requesting information from the
public (e.g., details of studies conducted). We are looking for studies
that report on Genitourinary Syndrome of Menopause, including those
that describe adverse events. The entire research protocol is available
online at: https://effectivehealthcare.ahrq.gov/products/genitourinary-syndrome/protocol.
This is to notify the public that the EPC Program would find the
following information on Genitourinary Syndrome of Menopause helpful:
[ssquf] A list of completed studies that your organization has
sponsored for this indication. In the list, please indicate whether
results are available on ClinicalTrials.gov along with the
ClinicalTrials.gov trial number.
[ssquf] For completed studies that do not have results on
ClinicalTrials.gov, a summary, including the following elements: study
number, study period, design, methodology, indication and diagnosis,
proper use instructions, inclusion and exclusion criteria, primary and
secondary outcomes, baseline characteristics, number of patients
screened/eligible/enrolled/lost to follow-up/withdrawn/analyzed,
effectiveness/efficacy, and safety results.
[[Page 14617]]
[ssquf] A list of ongoing studies that your organization has
sponsored for this indication. In the list, please provide the
ClinicalTrials.gov trial number or, if the trial is not registered, the
protocol for the study including a study number, the study period,
design, methodology, indication and diagnosis, proper use instructions,
inclusion and exclusion criteria, and primary and secondary outcomes.
[ssquf] Description of whether the above studies constitute ALL
Phase II and above clinical trials sponsored by your organization for
this indication and an index outlining the relevant information in each
submitted file.
Your contribution is very beneficial to the Program. Materials
submitted must be publicly available or able to be made public.
Materials that are considered confidential; marketing materials; study
types not included in the review; or information on indications not
included in the review cannot be used by the EPC Program. This is a
voluntary request for information, and all costs for complying with
this request must be borne by the submitter.
The draft of this review will be posted on AHRQ's EPC Program
website and available for public comment for a period of 4 weeks. If
you would like to be notified when the draft is posted, please sign up
for the email list at: https://www.effectivehealthcare.ahrq.gov/email-updates.
The systematic review will answer the following questions. This
information is provided as background. AHRQ is not requesting that the
public provide answers to these questions.
Key Questions (KQ)
KQ 1: What is the effectiveness and harms of screening strategies
to identify GSM in postmenopausal women? Does screening impact patient
reported symptoms or improve quality of life?
KQ 2: What is the effectiveness and comparative effectiveness of
hormonal, non-hormonal, and energy-based interventions when used alone
or in combination for treatment of GSM symptoms? Which treatments show
improvement for which symptoms?
KQ 3: What are the harms (and comparative harms) of hormonal, non-
hormonal, and energy-based interventions for GSM symptoms?
KQ 4: What is the appropriate follow-up interval to assess
improvement, sustained improvement, or regression of symptoms of GSM in
women treated with hormonal, non-hormonal, and energy-based
interventions?
KQ 5: What is the effectiveness, comparative effectiveness, and
harms of endometrial surveillance among women who have a uterus and are
using hormonal therapy for GSM?
Population, Intervention, Comparator, Outcome, Timing, Setting/Study Design (PICOTS)
----------------------------------------------------------------------------------------------------------------
Inclusion Exclusion
----------------------------------------------------------------------------------------------------------------
Population:
KQ1:......................... Postmenopausal women..............................
KQ2-4:....................... Postmenopausal women, premenopausal women in Individuals with
hypoestrogenic state, or gender diverse genitourinary symptoms
individuals on hormonal therapy, with one or more for reasons other than
symptom of GSM. GSM.
KQ5:......................... Patients with a uterus using hormonal therapy Patients using hormonal
primarily for GSM symptoms. therapy for reasons
other than GSM.
Interventions:
KQ1:......................... Screening evaluations and/or questionnaires....... Physical exam.
KQ2-4:....................... Hormonal Interventions: Systemic estrogen for GSM, Menopausal hormone
vaginal estrogen therapy, including vaginal therapy only for reasons
cream, tablets, inserts or ring, selective other than GSM.
estrogen receptor modulator (SERM), intravaginal Laser therapy for
dehydroepiandrosterone (DHEA), vaginal anatomic areas other
testosterone, compounded and bioidentical than the vagina.
hormonal therapies; phytoestrogens. Pelvic floor physical
Energy-based interventions: CO2 laser, Erbium: therapy for urinary
YAG, radio-frequency laser. incontinence.
Non-hormonal interventions: Over-the-counter non-
hormone vaginal lubricants and moisturizers,
hyaluronic acid, herbal therapies/supplemental
alternatives, vitamin D, vitamin E, probiotics,
oxytocin vaginal gel, pelvic floor physical
therapy to treat vaginal or sexual symptoms of
GSM.
For KQ4. Assess different durations of follow-up..
KQ5:......................... Endometrial surveillance with ultrasound or biopsy
Comparison:
KQ1:......................... Usual care........................................
KQ2-4:....................... Effectiveness: Placebo, inactive control, sham.
Comparative Effectiveness: Another hormonal, non-
hormonal, or energy-based intervention..
For KQ4. Assess different durations of follow up..
KQ5:......................... Usual care, or different type or level of
surveillance.
Outcomes:
KQ1:......................... Diagnosis of GSM, potential harms: misdiagnosis as
another condition with similar presentation such
as inflammatory dermatologic conditions,
malignancy, infections, or presence of symptoms
prior to menopause. Progressing to unnecessary
diagnostics for the index patient such as vaginal
or endometrial biopsy.
KQ 1, 2&4........................ Change in symptoms:............................... Serum hormone
Genitourinary symptoms: urinary frequency, urinary concentration, Stress
urgency, nocturia, dysuria, recurrent urinary incontinence.
tract infections.
Other urinary symptoms (outcomes evaluated for
interventions other than PFMT): urinary urge
incontinence, overactive bladder.
Genital signs and symptoms: urethral caruncle,
urethral prolapse, vaginal atrophy or atrophic
vaginitis, vaginal dryness, vaginal/vulvar
irritation, vaginal soreness, vaginal
lubrication, vaginal pain.
Sexual symptoms: dyspareunia, orgasmic
dysfunction, low libido, decreased arousal,
sexual desire, sexual function, bleeding
associated with sexual activity.
[[Page 14618]]
Psychological symptoms: depression, anxiety,
quality of life, partner satisfaction.
KQ3&5:....................... Safety outcomes: breast cancer, breast cancer
recurrence or progression, breast tenderness,
cardiovascular risk, endometrial cancer (KQ5),
post-menopausal bleeding (KQ5), endometrial
hyperplasia (KQ5), endometrial thickness (KQ5).
Adverse events: worsening or onset of urinary,
genital, or sexual symptoms: vaginal burning,
vaginal bleeding, vaginal discharge, vaginal
scarring, vaginal stenosis; pelvic pain;
dyspareunia; urethral strictures; meatal
stricture/stenosis..
Systemic adverse events: chronic pain, stroke; VTE
(DVT or PE); death; hot flashes; headache; breast
pain; cramps; bloating; nausea; vomiting.
Timing:
All KQ....................... Intervention: any.
Outcomes: any.....................................
Setting:
All KQ....................... Any...............................................
Study design:
KQ1.......................... RCTs and prospective observational studies with
concurrent comparison group and analytic
techniques to control for sample selection bias;
systematic reviews of these study designs that
assessed ROB of included studies using validated
tools.
KQ2.......................... RCTs or systematic review of RCTs that assessed
ROB of included studies using validated tools.
KQ3.......................... RCTs and prospective observational studies with
concurrent comparison group and analytic
techniques to control for sample selection bias;
systematic reviews of these study designs that
assessed ROB of included studies using validated
tools.
KQ4.......................... RCTs or systematic review of RCTs that assessed
ROB of included studies using validated tools.
KQ5.......................... RCTs and prospective observational studies with
concurrent comparison group and analytic
techniques to control for sample selection bias;
systematic reviews of these study designs that
assessed ROB of included studies using validated
tools.
Language......................... English only (due to resource limitations)........
Geographic Location.............. Any...............................................
Study size....................... N = 20 or more participants analyzed per study arm
for RCTs.
Publication date................. Any...............................................
----------------------------------------------------------------------------------------------------------------
Abbreviations: CO2 = carbon dioxide; DHEA = dehydroepiandrosterone; DVT = deep venous thromboembolism; GSM =
Genitourinary Syndrome of Menopause; KQ = key question; PE = pulmonary embolism; PFMT = pelvic floor muscle
training; RCT = randomized controlled trial; SERM = selective estrogen receptor modulator; VTE = venous
thromboembolism.
Dated: March 3, 2023.
Marquita Cullom,
Associate Director.
[FR Doc. 2023-04800 Filed 3-8-23; 8:45 am]
BILLING CODE 4160-90-P
