Solicitation of Nominations for Membership To Serve on the Advisory Commission on Childhood Vaccines, 54700-54701 [2022-19242]
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Federal Register / Vol. 87, No. 172 / Wednesday, September 7, 2022 / Notices
See https://www.ssa.gov/OP_Home/
ssact/title05/0510.htm.
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Mary B. Jones,
ACF/OPRE Certifying Officer.
Food and Drug Administration
[Docket No. FDA–2018–N–1262]
[FR Doc. 2022–19231 Filed 9–6–22; 8:45 am]
AGENCY:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Proposal To Withdraw Approval of
MAKENA; Hearing; Correction
Food and Drug Administration,
HHS.
ACTION:
Notice of hearing; correction.
The Food and Drug
Administration (FDA) is correcting a
notice entitled ‘‘Proposal To Withdraw
Approval of MAKENA; Hearing’’ that
appeared in the Federal Register of
August 17, 2022. The document
announced the hearing on the Center for
Drug Evaluation and Research’s
proposal to withdraw approval of
MAKENA (hydroxyprogesterone
caproate injection, 250 milligrams per
milliliter, once weekly), new drug
application 021945, held by Covis
Pharma Group/Covis Pharma GmbH.
The document was published with an
incorrect deadline. This document
corrects that error.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Rachael Vieder Linowes, Office of
Scientific Integrity, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 1, Rm. 4206, Silver Spring,
MD 20993, 240–402–5931,
rachael.linowes@fda.hhs.gov.
In the
Federal Register of August 17, 2022 (87
FR 50626), in FR Doc. 2022–17715, on
page 50628, the following correction is
made:
1. On page 50628, in the last
paragraph of the second column, in the
first sentence, ‘‘September 6, 2022’’ is
corrected to ‘‘September 14, 2022.’’
lotter on DSK11XQN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
Dated: September 1, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19293 Filed 9–6–22; 8:45 am]
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The Food and Drug
Administration (FDA) is announcing the
issuance of a priority review voucher to
the sponsor of a rare pediatric disease
product application. The Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
amended by the Food and Drug
Administration Safety and Innovation
Act (FDASIA), authorizes FDA to award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA is required to publish notice of the
award of the priority review voucher.
FDA has determined that ZTALMY
(ganaxolone), manufactured by Marinus
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher.
FOR FURTHER INFORMATION CONTACT:
Cathryn Lee, Center for Drug Evaluation
and Research, Food and Drug
Administration, 10903 New Hampshire
Ave., Silver Spring, MD 20993–0002,
301–796–1394, email: Cathryn.Lee@
fda.hhs.gov.
SUPPLEMENTARY INFORMATION: FDA is
announcing the issuance of a priority
review voucher to the sponsor of an
approved rare pediatric disease product
application. Under section 529 of the
FD&C Act (21 U.S.C. 360ff), which was
added by FDASIA, FDA will award
priority review vouchers to sponsors of
approved rare pediatric disease product
applications that meet certain criteria.
FDA has determined that ZTALMY
(ganaxolone), manufactured by Marinus
Pharmaceuticals, Inc., meets the criteria
for a priority review voucher. ZTALMY
(ganaxolone) is indicated to treat
seizures associated with cyclindependent kinase-like 5 (CDKL5)
deficiency disorder in patients 2 years
of age and older.
For further information about the Rare
Pediatric Disease Priority Review
Voucher Program and for a link to the
full text of section 529 of the FD&C Act,
go to https://www.fda.gov/ForIndustry/
DevelopingProductsforRareDiseases
Conditions/RarePediatricDiseasePriority
VoucherProgram/default.htm. For
further information about ZTALMY
(ganaxolone), go to the ‘‘Drugs@FDA’’
website at https://www.accessdata.
fda.gov/scripts/cder/daf/.
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice.
SUMMARY:
[Docket No. FDA–2020–N–2029]
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
[FR Doc. 2022–19276 Filed 9–6–22; 8:45 am]
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Issuance of Priority Review Voucher;
Rare Pediatric Disease Product
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Dated: August 31, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
Sfmt 4703
Solicitation of Nominations for
Membership To Serve on the Advisory
Commission on Childhood Vaccines
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for nominations.
AGENCY:
HRSA is seeking nominations
of qualified candidates for consideration
for appointment as members of the
Advisory Commission on Childhood
Vaccines (ACCV). The ACCV advises
the Secretary of HHS (Secretary) on
issues related to implementation of the
National Vaccine Injury Compensation
Program (VICP). HRSA is seeking
nominations of qualified candidates to
fill vacancies on the ACCV.
DATES: Written nominations for
membership on the ACCV will be
received on a continuous basis.
ADDRESSES: Nomination packages must
be submitted to the Director, Division of
Injury Compensation Programs, Health
Systems Bureau, HRSA, 5600 Fishers
Lane, Room 08N146B, Rockville,
Maryland 20857. Candidates can submit
electronic nomination packages by
email to Pita Gomez at ACCV@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: Pita
Gomez, Principal Staff Liaison, Division
of Injury Compensation Programs,
Health Systems Bureau, HRSA at (301)
945–9386 or email at ACCV@hrsa.gov. A
copy of the ACCV charter and list of the
current membership is available on the
ACCV website at https://www.hrsa.gov/
advisory-committees/vaccines/
index.html.
SUMMARY:
The ACCV
was established by Title XXI of the
Public Health Service Act (the Act) and
advises the Secretary on issues related
to implementation of the VICP. The
ACCV meets at least four times each
calendar year.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on the ACCV to fill open
positions. The Secretary appoints
members with the expertise needed to
fulfill the duties of the ACCV. The
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 87, No. 172 / Wednesday, September 7, 2022 / Notices
membership requirements are set forth
in section 2119 of the National
Childhood Vaccine Injury Act.
The ACCV consists of nine voting
members appointed by the Secretary as
follows: (1) Three health professionals,
who are not employees of the U.S.
government, and who have expertise in
the health care of children, the
epidemiology, etiology, and prevention
of childhood diseases, and the adverse
reactions associated with vaccines, of
whom at least two shall be
pediatricians; (2) three members from
the general public, of whom at least two
shall be legal representatives (parents or
guardians) of children who have
suffered a vaccine-related injury or
death; and (3) three attorneys, of whom
at least one shall be an attorney whose
specialty includes representation of
persons who have suffered a vaccinerelated injury or death, and of whom
one shall be an attorney whose specialty
includes representation of vaccine
manufacturers. In addition, the Director
of the National Institutes of Health, the
Assistant Secretary for Health, the
Director of the Centers for Disease
Control and Prevention, and the
Commissioner of the Food and Drug
Administration (or the designees of such
officials) serve as non-voting ex officio
members.
HHS will consider nominations of all
qualified individuals with a view to
ensure that the ACCV includes the areas
of subject matter expertise noted above.
As indicated above, at least two of the
three ACCV members of the general
public must be legal representatives
(parents or guardians) of children who
have suffered a vaccine-related injury or
death. Because those members must be
the legal representatives of children
who have suffered a vaccine-related
injury or death, to be considered for
appointment to the ACCV in that
category, there must have been a finding
(i.e., a decision) by the U.S. Court of
Federal Claims or a civil court that a
VICP-covered vaccine caused, or was
presumed to have caused, the
represented child’s injury or death.
Additionally, based on a
recommendation made by the ACCV,
the Secretary will consider having a
health professional with expertise in
obstetrics as one of the members of the
general public. Interested applicants
may self-nominate or be nominated by
another individual or organization.
Individuals selected for appointment
to the Committee will be invited to
serve for up to 3 years. Members are
appointed as SGEs and receive a stipend
and reimbursement for per diem and
travel expenses incurred for attending
ACCV meetings and/or conducting other
VerDate Sep<11>2014
17:50 Sep 06, 2022
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business on behalf of the ACCV, as
authorized by 5 U.S.C. 5703 for persons
employed intermittently in government
service.
The following information must be
included in the package of materials
submitted for each individual
nominated for consideration: (1) a letter
of nomination stating the name,
affiliation, and contact information for
the nominee, the basis for the
nomination (i.e., what specific
attributes, perspectives, and/or skills
does the individual possess that would
benefit the workings of the ACCV) and
the nominee’s field(s) of expertise; (2)
the name, address, daytime telephone
number, and email address at which the
nominator can be contacted; and (3) a
current copy of the nominee’s
curriculum vitae. The individual being
nominated or the person/organization
recommending the candidate may
submit nomination packages directly to
HRSA, which will collect and retain
nomination packages to create a pool of
possible future ACCV voting members.
When a vacancy occurs, HRSA and HHS
will review nomination packages from
the appropriate category and nominees
may be contacted at that time.
HHS endeavors to ensure that the
membership of the ACCV is fairly
balanced in terms of points of view
represented and that individuals from a
broad representation of geographic
areas, gender, and ethnic and minority
groups, as well as individuals with
disabilities, are considered for
membership. Appointments shall be
made without discrimination on the
basis of race, age, ethnicity, national
origin, gender, disability, sexual
orientation, or cultural, religious, or
socioeconomic status.
Individuals who are selected to be
considered for appointment will be
required to provide detailed information
regarding their financial holdings,
consultancies, and research grants or
contracts. Disclosure of this information
is required for HRSA ethics officials to
determine whether there is a potential
conflict of interest between the SGE’s
public duties as a member of the ACCV
and their private interests, including an
appearance of a loss of impartiality as
defined by federal laws and regulations,
and to identify any required remedial
action needed to address the potential
conflict.
Authority: Under the authorities that
established the ACCV, the Federal
Advisory Committee Act of October 6,
1972, (Pub. L. 92–463) and section 2119
of the National Childhood Vaccine
Injury Act (Pub. L. 99–660, as
amended), HRSA is requesting
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54701
nominations for voting members of the
ACCV.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022–19242 Filed 9–6–22; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Findings of Research Misconduct
Office of the Secretary, HHS.
Notice.
AGENCY:
ACTION:
Findings of research
misconduct have been made against
Ritankar Majumdar, Ph.D. (Respondent),
who was a postdoctoral fellow in the
intramural program of the Laboratory of
Cellular and Molecular Biology (CMB),
Center for Cancer Research (CCR),
National Cancer Institute (NCI),
National Institutes of Health (NIH).
Respondent engaged in research
misconduct in research supported by
U.S. Public Health Service (PHS) funds,
specifically the NCI Intramural Research
Program. The administrative actions,
including supervision for a period of
three (3) years, were implemented
beginning on August 15, 2022, and are
detailed below.
FOR FURTHER INFORMATION CONTACT:
Wanda K. Jones, Dr.P.H., Acting
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:
Ritankar Majumdar, Ph.D., National
Institutes of Health: Based on the report
of an investigation conducted by NIH
and analysis conducted by ORI in its
oversight review, ORI found that Dr.
Ritankar Majumdar, former postdoctoral
fellow in the intramural program of the
Laboratory of CMB, CCR, NCI, NIH,
engaged in research misconduct in
research supported by PHS funds,
specifically the NCI Intramural Research
Program.
ORI found that Respondent engaged
in research misconduct by knowingly or
recklessly falsifying and/or fabricating
data in the following one (1) published
paper, one (1) manuscript, three (3) PHS
grant applications, and fifteen (15)
presentations:
• Exosomes Mediate LTB4 Release
during Neutrophil Chemotaxis. PloS
Biol. 2016 Jan 7; 14(1):e1002336; doi:
10.1371/journal.pbio.1002336 (hereafter
referred to as ‘‘PloS Biol 2016’’).
SUMMARY:
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]]>Agencies
[Federal Register Volume 87, Number 172 (Wednesday, September 7, 2022)]
[Notices]
[Pages 54700-54701]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19242]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Solicitation of Nominations for Membership To Serve on the
Advisory Commission on Childhood Vaccines
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
ACTION: Request for nominations.
-----------------------------------------------------------------------
SUMMARY: HRSA is seeking nominations of qualified candidates for
consideration for appointment as members of the Advisory Commission on
Childhood Vaccines (ACCV). The ACCV advises the Secretary of HHS
(Secretary) on issues related to implementation of the National Vaccine
Injury Compensation Program (VICP). HRSA is seeking nominations of
qualified candidates to fill vacancies on the ACCV.
DATES: Written nominations for membership on the ACCV will be received
on a continuous basis.
ADDRESSES: Nomination packages must be submitted to the Director,
Division of Injury Compensation Programs, Health Systems Bureau, HRSA,
5600 Fishers Lane, Room 08N146B, Rockville, Maryland 20857. Candidates
can submit electronic nomination packages by email to Pita Gomez at
[email protected].
FOR FURTHER INFORMATION CONTACT: Pita Gomez, Principal Staff Liaison,
Division of Injury Compensation Programs, Health Systems Bureau, HRSA
at (301) 945-9386 or email at [email protected]. A copy of the ACCV charter
and list of the current membership is available on the ACCV website at
https://www.hrsa.gov/advisory-committees/vaccines/.
SUPPLEMENTARY INFORMATION: The ACCV was established by Title XXI of the
Public Health Service Act (the Act) and advises the Secretary on issues
related to implementation of the VICP. The ACCV meets at least four
times each calendar year.
Nominations: HRSA is requesting nominations for voting members to
serve as Special Government Employees (SGEs) on the ACCV to fill open
positions. The Secretary appoints members with the expertise needed to
fulfill the duties of the ACCV. The
[[Page 54701]]
membership requirements are set forth in section 2119 of the National
Childhood Vaccine Injury Act.
The ACCV consists of nine voting members appointed by the Secretary
as follows: (1) Three health professionals, who are not employees of
the U.S. government, and who have expertise in the health care of
children, the epidemiology, etiology, and prevention of childhood
diseases, and the adverse reactions associated with vaccines, of whom
at least two shall be pediatricians; (2) three members from the general
public, of whom at least two shall be legal representatives (parents or
guardians) of children who have suffered a vaccine-related injury or
death; and (3) three attorneys, of whom at least one shall be an
attorney whose specialty includes representation of persons who have
suffered a vaccine-related injury or death, and of whom one shall be an
attorney whose specialty includes representation of vaccine
manufacturers. In addition, the Director of the National Institutes of
Health, the Assistant Secretary for Health, the Director of the Centers
for Disease Control and Prevention, and the Commissioner of the Food
and Drug Administration (or the designees of such officials) serve as
non-voting ex officio members.
HHS will consider nominations of all qualified individuals with a
view to ensure that the ACCV includes the areas of subject matter
expertise noted above. As indicated above, at least two of the three
ACCV members of the general public must be legal representatives
(parents or guardians) of children who have suffered a vaccine-related
injury or death. Because those members must be the legal
representatives of children who have suffered a vaccine-related injury
or death, to be considered for appointment to the ACCV in that
category, there must have been a finding (i.e., a decision) by the U.S.
Court of Federal Claims or a civil court that a VICP-covered vaccine
caused, or was presumed to have caused, the represented child's injury
or death. Additionally, based on a recommendation made by the ACCV, the
Secretary will consider having a health professional with expertise in
obstetrics as one of the members of the general public. Interested
applicants may self-nominate or be nominated by another individual or
organization.
Individuals selected for appointment to the Committee will be
invited to serve for up to 3 years. Members are appointed as SGEs and
receive a stipend and reimbursement for per diem and travel expenses
incurred for attending ACCV meetings and/or conducting other business
on behalf of the ACCV, as authorized by 5 U.S.C. 5703 for persons
employed intermittently in government service.
The following information must be included in the package of
materials submitted for each individual nominated for consideration:
(1) a letter of nomination stating the name, affiliation, and contact
information for the nominee, the basis for the nomination (i.e., what
specific attributes, perspectives, and/or skills does the individual
possess that would benefit the workings of the ACCV) and the nominee's
field(s) of expertise; (2) the name, address, daytime telephone number,
and email address at which the nominator can be contacted; and (3) a
current copy of the nominee's curriculum vitae. The individual being
nominated or the person/organization recommending the candidate may
submit nomination packages directly to HRSA, which will collect and
retain nomination packages to create a pool of possible future ACCV
voting members. When a vacancy occurs, HRSA and HHS will review
nomination packages from the appropriate category and nominees may be
contacted at that time.
HHS endeavors to ensure that the membership of the ACCV is fairly
balanced in terms of points of view represented and that individuals
from a broad representation of geographic areas, gender, and ethnic and
minority groups, as well as individuals with disabilities, are
considered for membership. Appointments shall be made without
discrimination on the basis of race, age, ethnicity, national origin,
gender, disability, sexual orientation, or cultural, religious, or
socioeconomic status.
Individuals who are selected to be considered for appointment will
be required to provide detailed information regarding their financial
holdings, consultancies, and research grants or contracts. Disclosure
of this information is required for HRSA ethics officials to determine
whether there is a potential conflict of interest between the SGE's
public duties as a member of the ACCV and their private interests,
including an appearance of a loss of impartiality as defined by federal
laws and regulations, and to identify any required remedial action
needed to address the potential conflict.
Authority: Under the authorities that established the ACCV, the
Federal Advisory Committee Act of October 6, 1972, (Pub. L. 92-463) and
section 2119 of the National Childhood Vaccine Injury Act (Pub. L. 99-
660, as amended), HRSA is requesting nominations for voting members of
the ACCV.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2022-19242 Filed 9-6-22; 8:45 am]
BILLING CODE 4165-15-P
