60 D Frn

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Federal Register / Vol. 88, No. 125 / Friday, June 30, 2023 / Notices

of chronic rhinosinusitis without nasal
polyps or allergic fungal rhinosinusitis.
This guidance finalizes the draft
guidance of the same title issued on
December 10, 2021 (86 FR 70505). FDA
considered comments received on the
draft guidance in this finalized
guidance. Chronic rhinosinusitis is
characterized by inflammation of the
nasal mucosa and paranasal sinuses and
can be further divided into chronic
rhinosinusitis with and without nasal
polyps. Nasal polyps are inflammatory
hyperplastic growths that protrude into
the nasal passages. Symptoms of
CRSwNP include nasal congestion,
nasal discharge, facial pain or pressure,
and loss of smell. Nasal polyps have
associated morbidity that can have
substantial impact on day-to-day
functioning. Because of differences in
natural history and treatment between
chronic rhinosinusitis with and without
nasal polyps, this guidance specifically
addresses aspects of trial design, safety
and efficacy assessment for CRSwNP.
Changes from the draft to the final
guidance include considerations for
efficacy assessments for CRSwNP.
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Chronic
Rhinosinusitis With Nasal Polyps:
Developing Drugs for Treatment.’’ It
does not establish any rights for any
person and is not binding on FDA or the
public. You can use an alternative
approach if it satisfies the requirements
of the applicable statutes and
regulations.
II. Paperwork Reduction Act of 1995

information contained in 21 CFR part
312 relating to investigational new drug
applications have been approved under
OMB control number 0910–0014. The
collections of information in 21 CFR
part 314 relating to new drug
applications have been approved under
OMB control number 0910–0001. The
collections of information contained in
21 CFR part 601 relating to biologics
license applications have been approved
under OMB control number 0910–0338.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/drugs/guidancecompliance-regulatory-information/
guidances-drugs, https://www.fda.gov/
vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https://
www.fda.gov/regulatory-information/
search-fda-guidance-documents, or
https://www.regulations.gov.
Dated: June 26, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–13884 Filed 6–29–23; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
[Document Identifier: OS–0990–0438]

Agency Information Collection
Request; 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.

AGENCY:
ACTION:

In compliance with the
requirement of the Paperwork
Reduction Act of 1995, the Office of the
Secretary (OS), Department of Health
and Human Services, is publishing the
following summary of a proposed
collection for public comment.
DATES: Comments on the ICR must be
received on or before August 29, 2023.
ADDRESSES: Submit your comments to
[email protected] or by calling
(202) 264–0041 and [email protected].
SUMMARY:

While this guidance contains no
collection of information, it does refer to
previously approved FDA collections of
information. Therefore, clearance by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501–
3521) is not required for this guidance.
The previously approved collections of
information are subject to review by
OMB under the PRA. The collections of

FOR FURTHER INFORMATION CONTACT:

When submitting comments or
requesting information, please include
the document identifier 0990-New-60D
and project title for reference, to
Sherrette A. Funn, email:
[email protected], PRA@
HHS.GOV or call (202) 264–0041 the
Reports Clearance Officer.
SUPPLEMENTARY INFORMATION: Interested
persons are invited to send comments
regarding this burden estimate or any
other aspect of this collection of
information, including any of the
following subjects: (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.
Title of the Collection: FY2020 Teen
Pregnancy Prevention (TPP) Program
Performance Measures.
Type of Collection: Extension.
OMB No.: 0990–0438.
Abstract: The Office of Population
Affairs (OPA), in the Office of the
Assistant Secretary for Health (OASH),
U.S. Department of Health and Human
Services (HHS), requests a renewal
clearance for the collection of
performance measures specifically for
FY2020 Teen Pregnancy Prevention
(TPP) Program grantees. Collection of
performance measures is a requirement
of all TPP awards and is included in the
NOFOs. The data collection will allow
OPA to comply with federal
accountability and performance
requirements, inform stakeholders of
grantee progress in meeting TPP
program goals, provide OPA with
metrics for monitoring TPP grantees,
and facilitate individual grantees’
continuous quality improvement efforts
within their projects. OPA requests
clearance for one year to cover reporting
during the no-cost extension period of
the awards.

ANNUALIZED BURDEN HOUR TABLE

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Forms
(if necessary)
Grantees
Grantees
Grantees
Grantees
Grantees
Grantees
Grantees

Respondents
(if necessary)

(partners and sustainability)
(training) ..............................
(dissemination) ....................
(Stakeholder Engagement)
( Reach and Demographics)
(Dosage) .............................
(Fidelity and Quality) ...........

VerDate Sep<11>2014

19:33 Jun 29, 2023

Number of
respondents

All TPP grantees ................................
All TPP Grantees ...............................
All TPP Grantees ...............................
All TPP Grantees ...............................
Tier 1 and Tier 2 Phase II Grantees ..
Tier 1 and Tier 2 Phase II Grantees ..
Tier 1 and Tier 2 Phase II Grantees ..

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Number of
responses per
respondents

90
90
90
90
64
64
64

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2
2
2
2
2
2
2

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Average
burden per
response
15/60
15/60
30/60
15/60
3
2
2

Total
burden
hours
45
45
90
45
384
256
256

42377

Federal Register / Vol. 88, No. 125 / Friday, June 30, 2023 / Notices
ANNUALIZED BURDEN HOUR TABLE—Continued
Forms
(if necessary)
Total .............................................

Respondents
(if necessary)

Number of
respondents

.............................................................

........................

Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2023–13909 Filed 6–29–23; 8:45 am]
BILLING CODE 4150–34–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Request for Information: Draft HHS
2023 Framework To Support and
Accelerate Smoking Cessation
Office of the Assistant
Secretary for Health (OASH), Office of
the Secretary, Department of Health and
Human Services (HHS).
ACTION: Notice of request for
information.
AGENCY:

The Department of Health and
Human Services (HHS or Department) is
issuing this request for information
(RFI) to receive input from the public on
the Draft HHS 2023 Framework to
Support and Accelerate Smoking
Cessation to guide the Department’s
efforts to sustain and strengthen existing
programs and drive further progress
toward smoking cessation, with an
emphasis on serving populations and
communities disproportionately
impacted by smoking-related morbidity
and mortality.
DATES: To be assured consideration,
comments must be received at the email
address provided below, no later than
midnight Eastern Time (ET) on July 30,
2023. HHS will not reply individually to
responders but will consider all
comments submitted by the deadline.
Please do not provide confidential
information as comments may be
published or otherwise used for agency
purposes.
ADDRESSES: Please submit all comments
via email to HHSSmokingCessation
[email protected] as a Word
document, Portable Document Format
(PDF), or in the body of an email. Please
include ‘‘Request for Information: Draft
HHS 2023 Framework to Support and
Accelerate Smoking Cessation’’ in the
subject line of the email message.
FOR FURTHER INFORMATION CONTACT:
Please submit questions for further
information to Sarah Boateng, Principal
Deputy Assistant Secretary for Health.

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SUMMARY:

VerDate Sep<11>2014

19:33 Jun 29, 2023

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Email: [email protected] at (202)
205–0725.
SUPPLEMENTARY INFORMATION: The
mission of HHS is to enhance the health
and well-being of all Americans, by
providing for effective health and
human services and by fostering sound,
sustained advances in the sciences
underlying medicine, public health, and
social services.
On February 22, 2022, President Joe
Biden and First Lady Jill Biden reignited
the Cancer Moonshot, setting an
ambitious, achievable goal: to reduce
the death rate from cancer by at least 50
percent over the next 25 years and
improve the experience of people and
families living with and surviving
cancer, ultimately ending cancer as we
know it. Additionally, on January 20,
2021, President Biden signed Executive
Order 13985, Advancing Racial Equity
and Support for Underserved
Communities Through the Federal
Government, which directed the
Department to make achieving health
equity part of its mission by developing
programs, policies, and activities to
address the disproportionately high and
adverse health disparities in
underserved communities. Then on
February 16, 2023, President Biden
signed Executive Order 14091, Further
Advancing Racial Equity and Support
for Underserved Communities Through
the Federal Government. This second
Executive Order reaffirmed the
Administration’s commitment to health
equity by extending and strengthening
equity-advancing requirements for
agencies.
To support the executive order
initiatives, and to pursue the
Administration’s priorities for
advancing health equity and driving
down cancer deaths, the Office of the
Assistant Secretary for Health (OASH) is
leading the development of a framework
to support and accelerate smoking
cessation. The Draft HHS 2023
Framework to Support and Accelerate
Smoking Cessation (the Framework)
will provide direction to enhance
collaboration and coordination across
HHS, and with Federal and non-Federal
stakeholders, drive further progress
toward smoking cessation and
delivering equitable outcomes for all
persons in America. The draft
Framework was developed with valued

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Number of
responses per
respondents
2

Average
burden per
response
........................

Total
burden
hours
1,155

input from subject matter experts across
HHS Operating Divisions. The
Framework aims to accelerate smoking
cessation and reduce smoking-related
health disparities by building on current
activities and collaborations across the
Department, including work guided by
the HHS Tobacco Control Strategic
Action Plan developed in 2010.
The scope is focused on cessation of
the use of commercial cigarettes, cigars,
and cigarillos, for people of all ages
across the lifespan. The Department also
recognizes the importance of tobacco
use prevention and cessation of other
tobacco products. These issues as well
as those related to e-cigarettes are topics
that are out of scope for this phase but
will be addressed in a later phase of this
effort.
The purpose of this request for
information (RFI) is to seek public
comment on the Draft 2023 Framework
to Support and Accelerate Smoking
Cessation. Please see the Draft
Framework below, followed by an RFI
in the form of questions to the public.
Draft U.S. Department of Health and
Human Services 2023 Framework To
Support and Accelerate Smoking
Cessation
Background
Cigarette smoking is the leading cause
of preventable disease, disability, and
death in the United States, including
about 30% of all cancer deaths.
Enormous progress has been made over
the last 60 years in driving down rates
of cigarette smoking. In 2021, 11.5% of
U.S. adults smoked cigarettes, down
from an all-time high of 42%, and twothirds (66.5%) of all adults who ever
smoked cigarettes have quit. Despite
this progress, cigarette smoking still
claims approximately 480,000 American
lives every year.
Furthermore, the gains that have been
made over the past several decades have
not occurred equally across the
population, leaving behind many of
those who have the least resources and
who face the greatest barriers to
quitting. Encouraging and assisting
every person in America to quit
smoking is critical to ensuring a
healthier future for all people in
America and to helping achieve the
Cancer Moonshot goal of reducing
cancer death rates by at least half over

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