Solicitation of Nominations for Membership To Serve on the Advisory Commission on Childhood Vaccines, 71907-71908 [2024-19808]
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Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–P–2513]
Determination That FLAGYL
(Metronidazole) Tablets, 250 Milligrams
and 500 Milligrams, Were Not
Withdrawn From Sale for Reasons of
Safety or Effectiveness
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) has
determined that FLAGYL
(metronidazole) tablets, 250 milligrams
(mg) and 500 mg, were not withdrawn
from sale for reasons of safety or
effectiveness. This determination means
that FDA will not begin procedures to
withdraw approval of abbreviated new
drug applications (ANDAs) that refer to
these drug products, and it will allow
FDA to continue to approve ANDAs that
refer to these products as long as they
meet relevant legal and regulatory
requirements.
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
FOR FURTHER INFORMATION CONTACT:
Neerja Razdan, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6217,
Silver Spring, MD 20993–0002, 301–
796–3600, Neerja.Razdan@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Section
505(j) of the Federal Food, Drug, and
Cosmetic Act (FD&C Act) (21 U.S.C.
355(j)) allows the submission of an
ANDA to market a generic version of a
previously approved drug product. To
obtain approval, the ANDA applicant
must show, among other things, that the
generic drug product: (1) has the same
active ingredient(s), dosage form, route
of administration, strength, conditions
of use, and (with certain exceptions)
labeling as the listed drug, which is a
version of the drug that was previously
approved, and (2) is bioequivalent to the
listed drug. ANDA applicants do not
have to repeat the extensive clinical
testing otherwise necessary to gain
approval of a new drug application
(NDA).
Section 505(j)(7) of the FD&C Act
requires FDA to publish a list of all
approved drugs. FDA publishes this list
as part of the ‘‘Approved Drug Products
With Therapeutic Equivalence
Evaluations,’’ which is known generally
as the ‘‘Orange Book.’’ Under FDA
regulations, drugs are removed from the
list if the Agency withdraws or
suspends approval of the drug’s NDA or
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21:26 Sep 03, 2024
Jkt 262001
ANDA for reasons of safety or
effectiveness or if FDA determines that
the listed drug was withdrawn from sale
for reasons of safety or effectiveness (21
CFR 314.162).
A person may petition the Agency to
determine, or the Agency may
determine on its own initiative, whether
a listed drug was withdrawn from sale
for reasons of safety or effectiveness.
This determination may be made at any
time after the drug has been withdrawn
from sale, but must be made prior to
approving an ANDA that refers to the
listed drug (§ 314.161 (21 CFR 314.161)).
FDA may not approve an ANDA that
does not refer to a listed drug.
FLAGYL (metronidazole) tablets, 250
mg and 500 mg, are the subject of NDA
012623, held by Pfizer, Inc., and
initially approved prior to Jan 1, 1982.
FLAGYL is indicated for treatment of
symptomatic Trichomoniasis,
asymptomatic Trichomoniasis,
treatment of asymptomatic sexual
partners, Amebiasis, anaerobic bacterial
infections among other infections, as
listed on the product label, and as
clinically indicated for treatment.
FLAGYL (metronidazole) tablets, 250
mg and 500 mg, are currently listed in
the ‘‘Discontinued Drug Product List’’
section of the Orange Book.
Innogenix LLC submitted a citizen
petition dated May 21, 2024 (Docket No.
FDA–2024–P–2513), under 21 CFR
10.30, requesting that the Agency
determine whether FLAGYL
(metronidazole) tablets, 250 mg and 500
mg, were withdrawn from sale for
reasons of safety or effectiveness.
After considering the citizen petition
and reviewing Agency records and
based on the information we have at this
time, FDA has determined under
§ 314.161 that FLAGYL (metronidazole)
tablets, 250 mg and 500 mg, were not
withdrawn for reasons of safety or
effectiveness. The petitioner has
identified no data or other information
suggesting that FLAGYL
(metronidazole) tablets, 250 mg and 500
mg, were withdrawn for reasons of
safety or effectiveness. We have
carefully reviewed our files for records
concerning the withdrawal of FLAGYL
(metronidazole) tablets, 250 milligrams
and 500 milligrams, from sale. We have
also independently evaluated relevant
literature and data for possible
postmarketing adverse events. We have
reviewed the available evidence and
determined that these drug products
were not withdrawn from sale for
reasons of safety or effectiveness.
Accordingly, the Agency will
continue to list FLAGYL
(metronidazole) tablets, 250 mg and 500
mg, in the ‘‘Discontinued Drug Product
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Frm 00030
Fmt 4703
Sfmt 4703
71907
List’’ section of the Orange Book. The
‘‘Discontinued Drug Product List’’
delineates, among other items, drug
products that have been discontinued
from marketing for reasons other than
safety or effectiveness. FDA will not
begin procedures to withdraw approval
of approved ANDAs that refer to this
drug product. Additional ANDAs for
these drug products may also be
approved by the Agency as long as they
meet all other legal and regulatory
requirements for the approval of
ANDAs. If FDA determines that labeling
for these drug products should be
revised to meet current standards, the
Agency will advise ANDA applicants to
submit such labeling.
Dated: August 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–19721 Filed 9–3–24; 8:45 am]
BILLING CODE 4164–01–P
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
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 to consider for
appointment as members of the
Advisory Commission on Childhood
Vaccines (ACCV or Commission). ACCV
advises the Secretary of HHS (the
Secretary) on issues related to the
implementation of the National Vaccine
Injury Compensation Program (VICP).
DATES: Written nominations for
membership on 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 08W–25A, Rockville,
Maryland 20857. Electronic nomination
packages can be submitted by email to
ACCV@hrsa.gov.
FOR FURTHER INFORMATION CONTACT: Pita
Gomez, Principal Staff Liaison, Division
of Injury Compensation Programs,
Health Systems Bureau, HRSA, at 1–
800–338–2382 or email at ACCV@
hrsa.gov. A copy of the ACCV charter
and list of the current membership may
be obtained by accessing the ACCV
SUMMARY:
E:\FR\FM\04SEN1.SGM
04SEN1
71908
Federal Register / Vol. 89, No. 171 / Wednesday, September 4, 2024 / Notices
website at https://www.hrsa.gov/
advisory-committees/vaccines/
index.html.
ACCV was
established by Title XXI of the Public
Health Service Act and advises the
Secretary on issues related to
implementation of the VICP. ACCV
meets four times each calendar year, or
at the discretion of the Designated
Federal Officer in consultation with the
Chair.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
(SGEs) on ACCV to fill open positions.
The Secretary appoints ACCV members
with the expertise needed to fulfill the
duties of the Commission. The
membership requirements are set forth
in section 2119 of the Public Health
Service Act.
ACCV consists of nine voting
members appointed by the Secretary as
follows: (1) three health professionals,
who are not employees of the United
States 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 nonvoting ex officio
members.
HHS will consider nominations of all
qualified individuals to ensure the
ACCV includes the areas of subject
matter expertise noted above. As
indicated, at least two of the three
ACCV members from the general public
must be legal representatives (parents or
guardians) 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
ddrumheller on DSK120RN23PROD with NOTICES1
SUPPLEMENTARY INFORMATION:
VerDate Sep<11>2014
21:26 Sep 03, 2024
Jkt 262001
presumed to have caused, the
represented child’s injury or death.
Additionally, based on a
recommendation made by ACCV, the
Secretary will consider having a health
professional with expertise in obstetrics
as one of the members from the general
public. Interested applicants may selfnominate or be nominated by another
individual or organization.
Individuals selected for appointment
to the Commission will be invited to
serve for up to 3 years. Members
appointed as SGEs receive a stipend and
reimbursement for per diem and travel
expenses incurred for attending ACCV
meetings and/or conducting other
business on behalf of 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 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 or resume. Nomination
packages may be submitted directly by
the individual being nominated or by
the person/organization recommending
the candidate. Nomination packages
will be collected and retained to create
a pool of possible future ACCV voting
members. When a vacancy occurs,
nomination packages from the
appropriate category will be reviewed
and nominees may be contacted at that
time.
HHS endeavors to ensure that the
membership of ACCV is 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 age,
disability, race, ethnicity, gender, sexual
orientation, national origin, 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
PO 00000
Frm 00031
Fmt 4703
Sfmt 4703
determine whether there is a potential
conflict of interest between the SGE’s
public duties as a member of 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, as amended) and
42 U.S.C. 300aa–19, section 2119 of the
Public Health Services (PHS) Act, HRSA
is requesting nominations for voting
members of ACCV.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–19808 Filed 9–3–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Meeting of the Advisory Committee on
Infant and Maternal Mortality
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In accordance with the
Federal Advisory Committee Act, this
notice announces that the Advisory
Committee on Infant and Maternal
Mortality (ACIMM or Committee) has
scheduled a public meeting. Information
about ACIMM and the agenda for this
meeting can be found on the ACIMM
website at https://www.hrsa.gov/
advisory-committees/infant-mortality/
index.html.
DATES:
• October 16, 2024, from 9:30 a.m. to
5:15 p.m. Eastern Time; and
• October 17, 2024, from 9 a.m. to 1
p.m. Eastern Time.
ADDRESSES: This meeting will be held in
person at the Hubert H. Humphrey
Building, HHS Headquarters, 200
Independence Avenue SW, Conference
Room 505A, Washington, DC 20201,
and virtually via webinar. The webinar
link and log-in information will be
available at the ACIMM website before
the meeting at https://www.hrsa.gov/
advisory-committees/infant-mortality/
index.html.
FOR FURTHER INFORMATION CONTACT:
Vanessa Lee, MPH, Designated Federal
Official, Maternal and Child Health
Bureau, HRSA, 5600 Fishers Lane,
SUMMARY:
E:\FR\FM\04SEN1.SGM
04SEN1
]]>Agencies
[Federal Register Volume 89, Number 171 (Wednesday, September 4, 2024)]
[Notices]
[Pages 71907-71908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19808]
-----------------------------------------------------------------------
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 to
consider for appointment as members of the Advisory Commission on
Childhood Vaccines (ACCV or Commission). ACCV advises the Secretary of
HHS (the Secretary) on issues related to the implementation of the
National Vaccine Injury Compensation Program (VICP).
DATES: Written nominations for membership on 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 08W-25A, Rockville, Maryland 20857. Electronic
nomination packages can be submitted by email to [email protected].
FOR FURTHER INFORMATION CONTACT: Pita Gomez, Principal Staff Liaison,
Division of Injury Compensation Programs, Health Systems Bureau, HRSA,
at 1-800-338-2382 or email at [email protected]. A copy of the ACCV charter
and list of the current membership may be obtained by accessing the
ACCV
[[Page 71908]]
website at https://www.hrsa.gov/advisory-committees/vaccines/.
SUPPLEMENTARY INFORMATION: ACCV was established by Title XXI of the
Public Health Service Act and advises the Secretary on issues related
to implementation of the VICP. ACCV meets four times each calendar
year, or at the discretion of the Designated Federal Officer in
consultation with the Chair.
Nominations: HRSA is requesting nominations for voting members to
serve as Special Government Employees (SGEs) on ACCV to fill open
positions. The Secretary appoints ACCV members with the expertise
needed to fulfill the duties of the Commission. The membership
requirements are set forth in section 2119 of the Public Health Service
Act.
ACCV consists of nine voting members appointed by the Secretary as
follows: (1) three health professionals, who are not employees of the
United States 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
nonvoting ex officio members.
HHS will consider nominations of all qualified individuals to
ensure the ACCV includes the areas of subject matter expertise noted
above. As indicated, at least two of the three ACCV members from the
general public must be legal representatives (parents or guardians) 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 ACCV, the Secretary
will consider having a health professional with expertise in obstetrics
as one of the members from the general public. Interested applicants
may self-nominate or be nominated by another individual or
organization.
Individuals selected for appointment to the Commission will be
invited to serve for up to 3 years. Members appointed as SGEs receive a
stipend and reimbursement for per diem and travel expenses incurred for
attending ACCV meetings and/or conducting other business on behalf of
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 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 or resume. Nomination
packages may be submitted directly by the individual being nominated or
by the person/organization recommending the candidate. Nomination
packages will be collected and retained to create a pool of possible
future ACCV voting members. When a vacancy occurs, nomination packages
from the appropriate category will be reviewed and nominees may be
contacted at that time.
HHS endeavors to ensure that the membership of ACCV is 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 age, disability, race, ethnicity, gender, sexual orientation,
national origin, 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 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, as
amended) and 42 U.S.C. 300aa-19, section 2119 of the Public Health
Services (PHS) Act, HRSA is requesting nominations for voting members
of ACCV.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-19808 Filed 9-3-24; 8:45 am]
BILLING CODE 4165-15-P
