30 day FRN

jspears on DSK121TN23PROD with NOTICES1

Federal Register / Vol. 87, No. 84 / Monday, May 2, 2022 / Notices
and has waived its opportunity for a
hearing.
DATES: Approval is withdrawn as of
May 2, 2022.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On August
9, 2012, FDA approved NDA 202497 for
MARQIBO (vinCRIStine sulfate
LIPOSOME injection), 5 mg/5 mL, for
the treatment of adult patients with
Philadelphia chromosome-negative
(Ph-) acute lymphoblastic leukemia
(ALL) in second or greater relapse or
whose disease has progressed following
two or more anti-leukemia therapies,
under the Agency’s accelerated approval
regulations, 21 CFR part 314, subpart H.
The accelerated approval of MARQIBO
(vinCRIStine sulfate LIPOSOME
injection) for Ph-ALL included a
required postmarketing clinical trial
intended to verify the clinical benefit of
MARQIBO (vinCRIStine sulfate
LIPOSOME injection).
On September 24, 2021, FDA
published the Federal Register notice
‘‘Oncologic Drugs Advisory Committee;
Notice of Meeting; Establishment of a
Public Docket; Request for Comments,’’
announcing that MARQIBO
(vinCRIStine sulfate LIPOSOME
injection) would be discussed at an
Oncologic Drug Advisory Committee
Meeting (ODAC) scheduled for
December 2, 2021 (86 FR 53067). On
October 27, 2021, FDA met with
Acrotech to discuss the planned ODAC
meeting. At that meeting, the Agency
recommended the applicant voluntarily
request withdrawal of approval for
MARQIBO (vinCRIStine sulfate
LIPOSOME injection), 5 mg/5mL, due to
the lack of verification of clinical
benefit. The postmarketing trial required
to verify clinical benefit had not been
completed, and patient recruitment to
fulfill the PMR appeared to be
significantly challenging due to the
treatment options that are currently
available.
On November 19, 2021, Acrotech
submitted a letter asking FDA to
withdraw approval of NDA 202497 for
MARQIBO (vinCRIStine sulfate
LIPOSOME injection), 5 mg/5mL,
pursuant to § 314.150(d) (21 CFR
314.150(d)) and waiving its opportunity
for a hearing. On November 23, 2021,
FDA acknowledged Acrotech’s request
for withdrawal of approval of the NDA
and waiver of its opportunity for

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hearing. FDA also cancelled the ODAC
meeting scheduled for December 2,
2021, since Acrotech’s withdrawal
request made discussion at an advisory
committee meeting moot.
For the reasons discussed above, and
in accordance with the applicant’s
request, approval of NDA 202497 for
MARQIBO (vinCRIStine sulfate
LIPOSOME injection), 5 mg/5mL, and
all amendments and supplements
thereto, is withdrawn under
§ 314.150(d). Distribution of MARQIBO
(vinCRIStine sulfate LIPOSOME
injection) 5 mg/5mL, into interstate
commerce without an approved
application is illegal and subject to
regulatory action (see sections 505(a)
and 301(d) of the Federal Food, Drug,
and Cosmetic Act (21 U.S.C. 355(a) and
331(d)).
Dated: April 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–09235 Filed 4–29–22; 8:45 am]
BILLING CODE 4164–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–0895]

Issuance of Priority Review Voucher;
Material Threat Medical
Countermeasure Product
AGENCY:

Food and Drug Administration,

HHS.
ACTION:

Notice.

The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a material threat medical
countermeasure (MCM) product
application. The Federal Food, Drug,
and Cosmetic Act (FD&C Act), as
amended by the 21st Century Cures Act
(Cures Act), authorizes FDA to award
priority review vouchers to sponsors of
approved material threat MCM product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that INMAZEB
(atoltivimab, maftivimab, and
odesivimab-ebgn), manufactured by
Regeneron Pharmaceuticals, Inc., meets
the criteria for a material threat MCM
priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Elizabeth Sadove, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Silver Spring, MD
20993–0002, 301–796–8515, Fax: 301–
SUMMARY:

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25645

796–8615, email: EUA.OCET@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a material
threat MCM priority review voucher to
the sponsor of an approved material
threat MCM product application. Under
section 565A of the FD&C Act (21 U.S.C.
360bbb–4a), which was added by the
Cures Act (Pub. L. 114–255), FDA will
award priority review vouchers to
sponsors of approved material threat
MCM product applications that meet
certain criteria upon approval of those
applications. FDA has determined that
INMAZEB (atoltivimab, maftivimab, and
odesivimab-ebgn), manufactured by
Regeneron Pharmaceuticals, Inc., meets
the criteria for a material threat MCM
priority review voucher. INMAZEB was
approved on October 14, 2020.
mINMAZEB is a mixture of three
monoclonal antibodies indicated for the
treatment of infection caused by Zaire
ebolavirus (Ebola virus) in adult and
pediatric patients.
For further information about the
material threat MCM Priority Review
Voucher Program and for a link to the
full text of section 565A of the FD&C
Act, go to https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/mcm-relatedcounterterrorism-legislation. For further
information about INMAZEB
(atoltivimab, maftivimab, and
odesivimab-ebgn), go to the Drugs@FDA
website at https://
www.accessdata.fda.gov/scripts/cder/
daf/.
Dated: April 26, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–09315 Filed 4–29–22; 8:45 am]
BILLING CODE 4164–01–P

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

Agency Information Collection
Request; 30-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 June 1, 2022.
SUMMARY:

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25646

Federal Register / Vol. 87, No. 84 / Monday, May 2, 2022 / Notices

Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under 30-day Review—Open
for Public Comments’’ or by using the
search function.
FOR FURTHER INFORMATION CONTACT:
Sherrette Funn, Sherrette.Funn@hhs.gov
or (202) 795–7714. When submitting
comments or requesting information,
please include the document identifier
0990–New–30D and project title for
reference.
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: Evaluation of
the National Hypertension Control
Initiative (NHCI).
Type of Collection: (New) Agency
Information Collection Request.
OMB No.: 0990–NEW–OS/Office of
Minority Health (OMH).
Abstract: As part of the federal
response to COVID–19, the U.S.
Department of Health and Human
Services (HHS) has funded a new
initiative involving two cooperative
agreements with the American Heart
Association (AHA) to improve COVID–
19-related health outcomes by
addressing hypertension (high blood
pressure) among racial and ethnic
minority populations. The $32 million
project from the HHS Office of Minority
Health (OMH) and the Health Resources
and Services Administration (HRSA)
Bureau of Primary Health Care will
support the implementation of the
National Hypertension Control Initiative
(NHCI), a national initiative to improve
ADDRESSES:

blood pressure control among the most
at-risk populations, including racial and
ethnic minorities.
The NHCI will support 350
participating HRSA-funded health
centers by providing patient and
provider education and training for
effective hypertension control as well as
integration of remote blood pressure
monitoring technology into the
treatment of hypertension for patients
served by participating health centers.
The project will also utilize the
American Heart Association’s targeted
media campaigns and existing
partnerships with community-based
organizations (CBOs) to help reach
Black, Latino, and other impacted
communities with (i) culturally and
linguistically appropriate messages, (ii)
access to blood pressure screenings, and
(iii) connection to health centers to
encourage proper treatment and
management of hypertension of
screened individuals. This initiative
serves to increase the number of adult
patients with controlled hypertension
and reduce the potential risk of COVIDrelated health outcomes.
AHA aims to conduct an evaluation to
assess the feasibility of the
implementation of each of the three
NHCI strategies. The findings of this
evaluation will inform the improvement
and tailoring of AHA’s communication
approaches about the importance of and
techniques for improving blood pressure
control, including the benefits of
accurately measuring, rapidly acting,
and having a patient-focused approach
to blood pressure control.
Methodology
The evaluation of the NHCI project
will use a mixed methods design,
integrating both quantitative and
qualitative data collection and analyses.
Three main goals of data collection will
be to: (1) Track and monitor systems
change implementation process
information from Community Health
Centers (CHCs) on a quarterly basis, (2)
assess the capacity of NHCI partners to
implement the NHCI project, their
needs, the strengths and weaknesses of
the systems change approach, and the
feasibility of the implementation of the
NHCI in their organizations and

communities, and (3) assess the reach
and success of NHCI project strategies
implemented by partners.
Specifically, the AHA will engage in:
1. Primary Data Collection
a. Qualtrics Survey. Collecting
participation and outcome data from
CHCs and CBOs using an online survey
administered using Qualtrics. This will
be used during the first two quarterly
data collection periods.
b. DREaM. Collecting participation
and outcome data from CHCs and CBOs
using an online Data Reporting,
Evaluation, and Monitoring (DREaM)
dashboard. This is the evolution of the
Qualtrics survey and will be used after
the first two quarterly data collection
periods.
c. Feasibility Assessments. Engaging
in qualitative and quantitative data
collection using focus groups,
interviews and questionnaires from
CHCs and CBOs to assess the feasibility
of various data collection and program
implementation approaches.
d. EmPOWERED to Serve.
Administering health lessons to
community members via Communitybased Organizations and assessing
awareness, education, and referral
outcomes.
2. Secondary Data Collection
a. Social Needs Platforms. CBOs and
CHCs will be asked to use one of two
publicly available social needs
platforms (Find Help or Unite Us) and
CHCs will be asked to use the Unite Us
social needs platform to connect
individuals receiving services at the
CBOs to Community Health Centers
(CHCs), and vice versa, to receive
additional blood pressure-related
services.
b. Remote Patient Monitoring. AHA
will be partnering with Canary
Telehealth to collect aggregate metrics
from a subset of Community Health
Centers (CHCs).
c. Blood Pressure Control Metrics via
Electronic Health Records. AHA will be
partnering with external research
partners to obtain reports of aggregated
blood pressure control metrics from
NHCI CHCs to inform clinical decision
making, clinical quality improvement,
and clinical outcomes.

jspears on DSK121TN23PROD with NOTICES1

ANNUALIZED BURDEN HOUR TABLE
Number of
respondents

Type of respondent

CHCs: Qualtrics survey (4 quarters) ...............................................................
CBOs: Qualtrics survey (4 quarters) ...............................................................
CHCs: Training on data entry into DREaM .....................................................

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Number
responses per
respondent

350
16
350

E:\FR\FM\02MYN1.SGM

2
2
1

02MYN1

Average
burden per
response
(in hours)
1.5
1.5
1

Total
burden hours
1,050
192
350

25647

Federal Register / Vol. 87, No. 84 / Monday, May 2, 2022 / Notices
ANNUALIZED BURDEN HOUR TABLE—Continued
Number of
respondents

Type of respondent

Average
burden per
response
(in hours)

Total
burden hours

CBOs: Training on data entry into DREaM .....................................................
CHCs: Quarterly data entry in DREaM ...........................................................
CBOs: Quarterly data entry into DREaM ........................................................
CHCs: Feasibility assessment focus groups (3 times a year) ........................
CBOs: Feasibility assessment focus groups (3 times a year) ........................
Individual Consumers: ETS health lesson learning questionnaires ................
CHCs: Social Needs Platforms Readiness Assessment .................................
CBOs: Social Needs Platforms Readiness Assessment .................................
Individual Consumers: Social Needs Platform Participation ...........................
Management Occupation: RPM provider data delivery ...................................
CBOs: Remote Patient Monitoring (RPM) .......................................................
Individual Consumers: Remote Patient Monitoring (RPM) ..............................
Blood Pressure Control Metrics via Electronic Health Records ......................

16
350
16
16
16
3,120
350
16
10,000
1
5
2,750
0

1
2
2
3
3
1
1
1
1
4
1
1
0

1
1.5
30/60
1.5
1.5
10/60
15/60
15/60
10/60
1
1
1
0

16
1,050
16
72
72
1,872
87.5
4
1,666
4
5
2,750
0

Total ..........................................................................................................

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

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

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

8,141

Sherrette A. Funn,
Paperwork Reduction Act Reports Clearance
Officer, Office of the Secretary.
[FR Doc. 2022–09318 Filed 4–29–22; 8:45 am]
BILLING CODE 4150–29–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; 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
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.

jspears on DSK121TN23PROD with NOTICES1

Number
responses per
respondent

Name of Committee: Healthcare Delivery
and Methodologies Integrated Review Group;
Science of Implementation in Health and
Healthcare Study Section.
Date: June 8–9, 2022.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Wenjuan Wang, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3154,
Bethesda, MD 20892, (301) 480–8667,
wangw22@mail.nih.gov.

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Name of Committee: Infectious Diseases
and Immunology A Integrated Review Group;
Innate Immunity and Inflammation Study
Section.
Date: June 16–17, 2022.
Time: 9:30 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shahrooz Vahedi, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 810G,
Bethesda, MD 20892, (301) 496–9322,
vahedis@mail.nih.gov.
Name of Committee: Molecular, Cellular
and Developmental Neuroscience Integrated
Review Group; Cellular and Molecular
Biology of Neurodegeneration Study Section.
Date: June 23–24, 2022.
Time: 9:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Laurent Taupenot, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 4188,
MSC 7850, Bethesda, MD 20892, 301–435–
1203, laurent.taupenot@nih.gov.
Name of Committee: Bioengineering
Sciences & Technologies Integrated Review
Group; Biomaterials and Biointerfaces Study
Section.
Date: June 23–24, 2022.
Time: 9:30 a.m. to 8:30 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Shivani Sharma, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Bethesda, MD
20892, (240) 507–7661, shivani.sharma@
nih.gov.

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Name of Committee: Center for Scientific
Review Special Emphasis Panel; Topics in
Bacterial Pathogenesis.
Date: June 23–24, 2022.
Time: 10:00 a.m. to 7:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Susan Daum, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 3202,
Bethesda, MD 20892, 301–827–7233,
susan.boyle-vavra@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
Dated: April 26, 2022.
David W. Freeman,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2022–09328 Filed 4–29–22; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Aging; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
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

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02MYN1