Meeting of the Presidential Advisory Council on HIV/AIDS, 61339-61340 [2022-22013]
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Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
with a history of jet lag disorder. The
other studies were conducted in healthy
individuals with no evidence of
experiencing jet lag disorder. Dr. Dunn
evaluated Study 2102 and the other
study submitted by Vanda as supportive
evidence, Study VP–VEC–162–2101,
and concluded that they were small
phase 2 studies with design and
methodological limitations. He also
noted that jet lag disorder presents a
series of complaints and symptoms
beyond sleep disturbances and daytime
sleepiness, and the sleep disturbances of
jet lag disorder typically persist over
several days. Because Studies 3101 and
3107 lacked robust assessment of
important additional endpoints that
might have been able to address these
characteristics of jet lag disorder, Dr.
Dunn concluded the data submitted do
not support a finding of substantial
evidence of effectiveness of tasimelteon
for treatment of jet lag disorder. He also
denied Vanda’s requests: (1) for the
Division to consider a narrower
indication for treatment of insomnia and
daytime sleepiness in jet lag disorder,
because that request was raised after the
complete response letter and therefore
was outside the scope of the dispute
resolution process and (2) for FDA to
convene an Advisory Committee to
answer the question of whether the
supplement had provided substantial
evidence of effectiveness, because he
found no scientific questions that would
have been appropriate for consideration
by an Advisory Committee.
Vanda submitted another FDRR on
September 2, 2020, for review of the
Office of Neuroscience denial. Dr. Mary
Thanh Hai, then-Acting Deputy Director
of the Office of New Drugs (OND),
denied the second FDRR on behalf of
OND by correspondence dated October
21, 2020, based on her determination
that the application did not provide
substantial evidence of effectiveness for
tasimelteon for treatment of jet lag
disorder. Dr. Thanh Hai noted that the
regulatory history of this development
program revealed very clear advice from
FDA on the study population and
recommended endpoints for clinical
trials to support a marketing application
for the treatment of jet lag disorder. She
also agreed with Dr. Dunn’s denial of
Vanda’s requests regarding a narrower
indication and convening an Advisory
Committee.
On July 1, 2022, Vanda submitted a
request for an opportunity for a hearing
under § 314.110(b)(3) on whether there
are grounds under section 505(d) of the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 355(d)) for
denying approval of sNDA 205677–004.
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II. Notice of Opportunity for a Hearing
For the reasons stated above and as
explained in further detail in the August
16, 2019, complete response letter and
the August 4, 2020, and October 21,
2020, FDRR denials, notice is given to
Vanda and all other interested persons
that the Center Director proposes to
issue an order refusing to approve sNDA
205677–004 on the grounds that the
application fails to meet the criteria for
approval under section 505(d) of the
FD&C Act because there is a lack of
substantial evidence that the drug is
effective for treatment of jet lag disorder
(section 505(d)(5) of the FD&C Act).4
Vanda may request a hearing before
the Commissioner of Food and Drugs
(the Commissioner) on the Center
Director’s proposal to refuse to approve
sNDA 205677–004. Pursuant to
§ 314.200(c)(1) (21 CFR 314.200(c)(1)), if
Vanda decides to seek a hearing, it must
file: (1) a written notice of participation
and request for a hearing on or before
30 days after the notice is published in
the Federal Register; and (2) the studies,
data, information, and analyses relied
upon to justify a hearing, as specified in
§ 314.200, on or before 60 days after the
date the notice is published in the
Federal Register.
As stated in § 314.200(g), a request for
a hearing may not rest upon mere
allegations or denials but must present
specific facts showing that there is a
genuine and substantial issue of fact
that requires a hearing to resolve. We
note in this regard that because CDER
proposes to refuse to approve sNDA
205677–004 based on the multiple
deficiencies summarized above, any
hearing request from Vanda must
address all of those deficiencies. Failure
to request a hearing within the time
provided and in the manner required by
§ 314.200 constitutes a waiver of the
opportunity to request a hearing. If a
hearing request is not properly
submitted, FDA will issue a notice
refusing to approve sNDA 205677–004.
The Commissioner will grant a
hearing if there exists a genuine and
substantial issue of fact or if the
Commissioner concludes that a hearing
would otherwise be in the public
interest (§ 314.200(g)(6)). If a hearing is
granted, it will be conducted according
4 Section 505(d)(5) of the FD&C Act provides that
FDA shall refuse to approve an NDA supplement
if ‘‘there is a lack of substantial evidence that the
drug will have the effect it purports or is
represented to have under the conditions of use
prescribed, recommended, or suggested in the
proposed labeling thereof[.]’’ For the reasons
explained in this notice, CDER has concluded that
the data and information submitted in the
supplement do not show that the drug is effective
for the proposed conditions of use.
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61339
to the procedures provided in 21 CFR
parts 10 through 16 (21 CFR 314.201).
Paper submissions under this notice
of opportunity for a hearing should be
filed in one copy, except for those
submitted as ‘‘Confidential
Submissions’’ (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’ in
ADDRESSES). Except for data and
information prohibited from public
disclosure under 21 U.S.C. 331(j) or 18
U.S.C. 1905, submissions may be seen
in the Dockets Management Staff Office
between 9 a.m. and 4 p.m., Monday
through Friday, and on the internet at
https://www.regulations.gov. This notice
is issued under section 505(c)(1)(B) of
the FD&C Act and §§ 314.110(b)(3) and
314.200.
III. References
The following references marked with
an asterisk (*) are on display at the
Dockets Management Staff (see
ADDRESSES) and are available for
viewing by interested persons between
9 a.m. and 4 p.m., Monday through
Friday; they also are available
electronically at https://
www.regulations.gov. References
without asterisks are not on public
display at https://www.regulations.gov
because they have copyright restriction.
Some may be available at the website
address, if listed. References without
asterisks are available for viewing only
at the Dockets Management Staff. FDA
has verified the website addresses, as of
the date this document publishes in the
Federal Register, but websites are
subject to change over time.
1. Sateia, M., ‘‘Jet Lag Disorder,’’
International Classification of Sleep
Disorders, 3rd ed., Illinois: American
Academy of Sleep Medicine, pp. 220–
224, 2014.
* 2. FDA Guidance for Industry and Review
Staff, ‘‘Formal Dispute Resolution:
Sponsor Appeals Above the Division
Level,’’ November 2017, (available at
https://www.fda.gov/media/126910/
download), accessed August 30, 2022.
Dated: October 4, 2022.
Jacqueline Corrigan-Curay,
Principal Deputy Center Director, Center for
Drug Evaluation and Research.
[FR Doc. 2022–21932 Filed 10–7–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Meeting of the Presidential Advisory
Council on HIV/AIDS
Department of Health and
Human Services, Office of the Secretary,
Office of the Assistant Secretary for
Health.
AGENCY:
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61340
ACTION:
Federal Register / Vol. 87, No. 195 / Tuesday, October 11, 2022 / Notices
Notice.
As stipulated by the Federal
Advisory Committee Act, the U.S.
Department of Health and Human
Service is hereby giving notice that the
Presidential Advisory Council on HIV/
AIDS (PACHA or the Council) will
convene the 75th full council meeting
virtually on Monday, October 17, 2022
from approximately 12:00–2:00 p.m.
(ET). The meeting will be open to the
public and there will be a public
comment session; pre-registration is
required to provide public comment. To
pre-register to provide public comment,
please send an email to PACHA@
hhs.gov and include your name,
organization, and title by close of
business Monday, October 10, 2022.
There is also an option to submit
written statement by emailing PACHA@
hhs.gov by close of business Monday,
October 24, 2022. The meeting agenda
will be posted on the PACHA page on
HIV.gov at https://www.hiv.gov/federalresponse/pacha/about-pacha prior to
the meeting.
DATES: The meeting will be held on
Monday, Monday, October 17, 2022
from approximately 12:00–2:00 p.m.
(ET).
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Ms.
Caroline Talev, MPA, Senior
Management Analyst, at PACHA@
hhs.gov or Caroline.Talev@hhs.gov or
202–795–7622. Additional information
can be obtained by accessing the
Council’s page on the HIV.gov site at
www.hiv.gov/pacha.
SUPPLEMENTARY INFORMATION: PACHA
was established by Executive Order
12963, dated June 14, 1995, as amended
by Executive Order 13009, dated June
14, 1996 and is currently operating
under the authority given in Executive
Order 14048, dated September 30, 2021.
The Council was established to provide
advice, information, and
recommendations to the Secretary
regarding programs and policies
intended to promote effective HIV
diagnosis, treatment, prevention, and
quality care services. The functions of
the Council are solely advisory in
nature.
The Council consists of not more than
35 members. Council members are
selected from prominent community
leaders with particular expertise in, or
knowledge of, matters concerning HIV
and AIDS, public health, global health,
population health, philanthropy,
marketing or business, as well as other
national leaders held in high esteem
from other sectors of society. PACHA
selections also include persons with
lived HIV experience and racial/ethnic
and sexual and gender minority persons
disproportionately affected by HIV.
Council members are appointed by the
Secretary.
B. Kaye Hayes,
Deputy Assistant Secretary for Infectious
Disease, Director, Office of Infectious Disease
and HIV/AIDS Policy, Executive Director,
Presidential Advisory Council on HIV/AIDS,
Office of the Assistant Secretary for Health,
Department of Health and Human Services.
[FR Doc. 2022–22013 Filed 10–7–22; 8:45 am]
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FOR FURTHER INFORMATION CONTACT:
When submitting comments or
requesting information, please include
the document identifier 4040–0020–60D
and project title for reference, to Sagal
Musa, email: sagal.musa@hhs.gov, or
call (202) 205–2634 the Reports
Clearance Officer.
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.
SUPPLEMENTARY INFORMATION:
Title of the Collection: SF–424
Mandatory Form.
Type of Collection: Renewal.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
OMB No.: 4040–0020.
[Document Identifier: OS–4040–0020]
Agency Information Collection
Request. 60-Day Public Comment
Request
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Submit your comments to
sagal.musa@hhs.gov or by calling (202)
205–2634.
ADDRESSES:
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 December 12,
2022.
SUMMARY:
Abstract: The Standard 424
Mandatory form provides the Federal
grant-making agencies an alternative to
the Standard Form 424 data set and
form. Agencies may use SF–424
Mandatory Form for grant programs not
required to collect all the data that is
required on the SF–424 core data set
and form.
Type of respondent: The SF–424
Mandatory form is used by
organizations to apply for Federal
financial assistance in the form of
grants. This form is submitted to the
Federal grant-making agencies for
evaluation and review. This IC expires
on January 31, 2023. Grants.gov seeks a
three-year clearance of these collections.
khammond on DSKJM1Z7X2PROD with NOTICES
ANNUALIZED BURDEN HOUR TABLE
Average
burden per
response
Total
burden
hours
Respondents
(if necessary)
SF424 Mandatory Form ....................
Grant Applicants ...............................
5761
1
1
5761
Total ...........................................
...........................................................
5761
1
1
5761
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Number of
respondents
Number of
responses per
respondents
Forms
(if necessary)
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]]>Agencies
[Federal Register Volume 87, Number 195 (Tuesday, October 11, 2022)]
[Notices]
[Pages 61339-61340]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22013]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Meeting of the Presidential Advisory Council on HIV/AIDS
AGENCY: Department of Health and Human Services, Office of the
Secretary, Office of the Assistant Secretary for Health.
[[Page 61340]]
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: As stipulated by the Federal Advisory Committee Act, the U.S.
Department of Health and Human Service is hereby giving notice that the
Presidential Advisory Council on HIV/AIDS (PACHA or the Council) will
convene the 75th full council meeting virtually on Monday, October 17,
2022 from approximately 12:00-2:00 p.m. (ET). The meeting will be open
to the public and there will be a public comment session; pre-
registration is required to provide public comment. To pre-register to
provide public comment, please send an email to [email protected] and
include your name, organization, and title by close of business Monday,
October 10, 2022. There is also an option to submit written statement
by emailing [email protected] by close of business Monday, October 24,
2022. The meeting agenda will be posted on the PACHA page on HIV.gov at
https://www.hiv.gov/federal-response/pacha/about-pacha prior to the
meeting.
DATES: The meeting will be held on Monday, Monday, October 17, 2022
from approximately 12:00-2:00 p.m. (ET).
FOR FURTHER INFORMATION CONTACT: Ms. Caroline Talev, MPA, Senior
Management Analyst, at [email protected] or [email protected] or 202-
795-7622. Additional information can be obtained by accessing the
Council's page on the HIV.gov site at www.hiv.gov/pacha.
SUPPLEMENTARY INFORMATION: PACHA was established by Executive Order
12963, dated June 14, 1995, as amended by Executive Order 13009, dated
June 14, 1996 and is currently operating under the authority given in
Executive Order 14048, dated September 30, 2021. The Council was
established to provide advice, information, and recommendations to the
Secretary regarding programs and policies intended to promote effective
HIV diagnosis, treatment, prevention, and quality care services. The
functions of the Council are solely advisory in nature.
The Council consists of not more than 35 members. Council members
are selected from prominent community leaders with particular expertise
in, or knowledge of, matters concerning HIV and AIDS, public health,
global health, population health, philanthropy, marketing or business,
as well as other national leaders held in high esteem from other
sectors of society. PACHA selections also include persons with lived
HIV experience and racial/ethnic and sexual and gender minority persons
disproportionately affected by HIV. Council members are appointed by
the Secretary.
B. Kaye Hayes,
Deputy Assistant Secretary for Infectious Disease, Director, Office of
Infectious Disease and HIV/AIDS Policy, Executive Director,
Presidential Advisory Council on HIV/AIDS, Office of the Assistant
Secretary for Health, Department of Health and Human Services.
[FR Doc. 2022-22013 Filed 10-7-22; 8:45 am]
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