Solicitation of Nominations for Membership To Serve on the National Advisory Council on Nurse Education and Practice, 4960-4961 [2024-01396]
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Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices
regulatory review by FDA before the
item was marketed. Under these acts, a
product’s regulatory review period
forms the basis for determining the
amount of extension an applicant may
receive.
A regulatory review period consists of
two periods of time: a testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
actual amount of extension that the
Director of USPTO may award (for
example, half the testing phase must be
subtracted as well as any time that may
have occurred before the patent was
issued), FDA’s determination of the
length of a regulatory review period for
a human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, VOCABRIA
(cabotegravir sodium) indicated in
combination with EDURANT
(rilpivirine) for short-term treatment of
Human Immunodeficiency Virus-1
(HIV–1) infection in adults who are
virologically suppressed (HIV–1 RNA
less than 50 copies/mL) on a stable
antiretroviral regimen with no history of
treatment failure and with no known or
suspected resistance to either
cabotegravir or rilpivirine, for use as:
• oral lead-in to assess the tolerability
of cabotegravir prior to administration
of CABENUVA (cabotegravir;
rilpivirine) extended-release injectable
suspensions and
• oral therapy for patients who will
miss planned injection dosing with
CABENUVA.
Subsequent to this approval, the
USPTO received a patent term
restoration application for VOCABRIA
(U.S. Patent No. 8,410,103) from ViiV
Healthcare Company and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter
September 28, 2022, FDA advised the
USPTO that this human drug product
had undergone a regulatory review
period and that the approval of
VOCABRIA represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
VerDate Sep<11>2014
17:22 Jan 24, 2024
Jkt 262001
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
VOCABRIA is 4,719 days. Of this time,
4,085 days occurred during the testing
phase of the regulatory review period,
while 634 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: February 22,
2008. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on February 22, 2008.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: April 29, 2019. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
VOCABRIA (NDA 212887) was initially
submitted on April 29, 2019.
3. The date the application was
approved: January 21, 2021. FDA has
verified the applicant’s claim that NDA
212887 was approved on January 21,
2021.
This determination of the regulatory
review period establishes the maximum
potential length of a patent extension.
However, the USPTO applies several
statutory limitations in its calculations
of the actual period for patent extension.
In its application for patent extension,
this applicant seeks 1,742 days of patent
term extension.
III. Petitions
Anyone with knowledge that any of
the dates as published are incorrect may
submit either electronic or written
comments and, under 21 CFR 60.24, ask
for a redetermination (see DATES).
Furthermore, as specified in § 60.30 (21
CFR 60.30), any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period. To
meet its burden, the petition must
comply with all the requirements of
§ 60.30, including but not limited to:
must be timely (see DATES), must be
filed in accordance with § 10.20, must
contain sufficient facts to merit an FDA
investigation, and must certify that a
true and complete copy of the petition
has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th
Cong., 2d sess., pp. 41–42, 1984.)
Petitions should be in the format
specified in 21 CFR 10.30.
Submit petitions electronically to
https://www.regulations.gov at Docket
PO 00000
Frm 00070
Fmt 4703
Sfmt 4703
No. FDA–2013–S–0610. Submit written
petitions (two copies are required) to the
Dockets Management Staff (HFA–305),
Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD
20852.
Dated: January 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–01438 Filed 1–24–24; 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 National
Advisory Council on Nurse Education
and Practice
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 National
Advisory Council on Nurse Education
and Practice (NACNEP). NACNEP
provides advice and recommendations
to the Secretary of HHS (Secretary) on
policy, program development, and other
matters of significance concerning the
activities under Title VIII of the Public
Health Service (PHS) Act, including the
range of issues relating to the nurse
workforce, education, and practice
improvement. NACNEP also prepares
and submits an annual report to the
Secretary and Congress describing its
activities, including NACNEP’s findings
and recommendations concerning
activities under Title VIII, as required by
the PHS Act. HRSA is seeking
nominations of qualified candidates to
fill up to 11 open positions on NACNEP.
DATES: HRSA will accept nominations
for membership on NACNEP on a
continuous basis.
ADDRESSES: Nomination packages may
be submitted electronically by email to
BHWAdvisoryCouncil@hrsa.gov.
Nomination packages may also be
submitted by mail addressed to
Advisory Council Operations, Bureau of
Health Workforce, HRSA, 5600 Fishers
Lane, Room 15W10, Rockville,
Maryland 20857.
FOR FURTHER INFORMATION CONTACT: Dr.
Justin Bala-Hampton, Designated
Federal Officer, NACNEP, by phone at
(301) 443–2866, or by email at
BHWNACNEP@hrsa.gov. A copy of the
SUMMARY:
E:\FR\FM\25JAN1.SGM
25JAN1
khammond on DSKJM1Z7X2PROD with NOTICES
Federal Register / Vol. 89, No. 17 / Thursday, January 25, 2024 / Notices
NACNEP charter and a list of the
current membership may be obtained by
accessing the NACNEP website at
https://www.hrsa.gov/advisorycommittees/nursing.
SUPPLEMENTARY INFORMATION: NACNEP
advises and makes recommendations to
the Secretary and Congress on policy
matters arising in the administration of
Title VIII of the PHS Act, including the
range of issues relating to the nurse
workforce, nursing education, and
nursing practice improvement, as a
means of enhancing the health of the
public through the development of the
nurse workforce. NACNEP meets at least
twice each calendar year or may meet
more frequently 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
(SGE) on NACNEP to fill open positions.
The Secretary appoints NACNEP
members with the expertise needed to
fulfill the duties of the Advisory
Council. The membership requirements
are set forth at section 851(b) of Title
VIII of the PHS Act, as amended.
Nominees sought are individuals
representing leading authorities in the
various fields of nursing, higher and
secondary education, and associate
degree schools of nursing;
representatives of advanced education
nursing groups (such as nurse
practitioners, nurse midwives, clinical
nurse specialists, and nurse
anesthetists); hospitals and other
institutions and organizations which
provide nursing services; practicing
professional nurses; the general public;
and full-time students enrolled in
schools of nursing. In making such
appointments, the Secretary shall
ensure a fair balance between the
nursing specialties, a broad geographic
representation of members, and a
balance between urban and rural
members. Members shall be appointed
based on their competence, interest, and
knowledge of the mission of the
profession involved. As required by
PHS Act section 851(b)(3), the Secretary
shall ensure the adequate representation
of minorities. HRSA is particularly
interested in seeking nominations from
individuals who can represent
underrepresented groups in the nursing
profession.
The majority of NACNEP members
shall be nurses. Interested applicants
may self-nominate or be nominated by
another individual or organization.
Individuals selected for appointment
to NACNEP will be invited to serve a
term of 4 years. Members appointed as
VerDate Sep<11>2014
17:22 Jan 24, 2024
Jkt 262001
SGEs receive a stipend and
reimbursement for per diem and travel
expenses incurred for attending
NACNEP meetings and/or conducting
other business on behalf of NACNEP, as
authorized by section 5 U.S.C. 5703 for
persons employed intermittently in
government service and PHS Act section
762(g).
The following information must be
included in the package of materials
submitted for each individual
nominated for consideration: (1) if
nominated by another individual or
organization, a letter of nomination from
the nominator stating the basis for the
nomination (i.e., what specific
attributes, perspectives, and/or skills
does the individual possess that would
benefit the workings of NACNEP, and
the nominee’s field(s) of expertise), as
well as the nominator’s name,
affiliation, and contact information
(address, daytime telephone number,
and email address); (2) letter of interest
from the applicant stating the reasons
the applicant would like to serve on
NACNEP; (3) a biographical sketch of
the applicant, including the applicant’s
curriculum vitae and contact
information (address, daytime telephone
number, and email address).
Nomination packages may be submitted
directly by the applicant or by the
person/organization nominating the
candidate.
HHS endeavors to ensure that the
membership of NACNEP is balanced
fairly in terms of points of view
represented. Appointments shall be
made without discrimination of age,
race, ethnicity, gender, 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 NACNEP
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: NACNEP is authorized by
section 851 of the PHS Act (42 U.S.C.
297t), as amended. NACNEP is governed
by provisions of the Federal Advisory
PO 00000
Frm 00071
Fmt 4703
Sfmt 4703
4961
Committee Act of 1972 (5 U.S.C.
Chapter 10).
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024–01396 Filed 1–24–24; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
National Vaccine Injury Compensation
Program; List of Petitions Received
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
HRSA is publishing this
notice of petitions received under the
National Vaccine Injury Compensation
Program (the Program), as required by
the Public Health Service (PHS) Act, as
amended. While the Secretary of HHS is
named as the respondent in all
proceedings brought by the filing of
petitions for compensation under the
Program, the United States Court of
Federal Claims is charged by statute
with responsibility for considering and
acting upon the petitions.
FOR FURTHER INFORMATION CONTACT: For
information about requirements for
filing petitions, and the Program in
general, contact Lisa L. Reyes, Clerk of
Court, United States Court of Federal
Claims, 717 Madison Place NW,
Washington, DC 20005, (202) 357–6400.
For information on HRSA’s role in the
Program, contact the Director, National
Vaccine Injury Compensation Program,
5600 Fishers Lane, Room 08W–25A,
Rockville, Maryland 20857; (301) 443–
6593, or visit our website at: https://
www.hrsa.gov/vaccinecompensation/
index.html.
SUMMARY:
The
Program provides a system of no-fault
compensation for certain individuals
who have been injured by specified
childhood vaccines. Subtitle 2 of Title
XXI of the PHS Act, 42 U.S.C. 300aa–
10 et seq., provides that those seeking
compensation are to file a petition with
the United States Court of Federal
Claims and to serve a copy of the
petition to the Secretary of HHS, who is
named as the respondent in each
proceeding. The Secretary has delegated
this responsibility under the Program to
HRSA. The Court is directed by statute
to appoint special masters who take
evidence, conduct hearings as
appropriate, and make initial decisions
SUPPLEMENTARY INFORMATION:
E:\FR\FM\25JAN1.SGM
25JAN1
]]>Agencies
[Federal Register Volume 89, Number 17 (Thursday, January 25, 2024)]
[Notices]
[Pages 4960-4961]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-01396]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Solicitation of Nominations for Membership To Serve on the
National Advisory Council on Nurse Education and Practice
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 National Advisory Council on
Nurse Education and Practice (NACNEP). NACNEP provides advice and
recommendations to the Secretary of HHS (Secretary) on policy, program
development, and other matters of significance concerning the
activities under Title VIII of the Public Health Service (PHS) Act,
including the range of issues relating to the nurse workforce,
education, and practice improvement. NACNEP also prepares and submits
an annual report to the Secretary and Congress describing its
activities, including NACNEP's findings and recommendations concerning
activities under Title VIII, as required by the PHS Act. HRSA is
seeking nominations of qualified candidates to fill up to 11 open
positions on NACNEP.
DATES: HRSA will accept nominations for membership on NACNEP on a
continuous basis.
ADDRESSES: Nomination packages may be submitted electronically by email
to [email protected]. Nomination packages may also be
submitted by mail addressed to Advisory Council Operations, Bureau of
Health Workforce, HRSA, 5600 Fishers Lane, Room 15W10, Rockville,
Maryland 20857.
FOR FURTHER INFORMATION CONTACT: Dr. Justin Bala-Hampton, Designated
Federal Officer, NACNEP, by phone at (301) 443-2866, or by email at
[email protected]. A copy of the
[[Page 4961]]
NACNEP charter and a list of the current membership may be obtained by
accessing the NACNEP website at https://www.hrsa.gov/advisory-committees/nursing.
SUPPLEMENTARY INFORMATION: NACNEP advises and makes recommendations to
the Secretary and Congress on policy matters arising in the
administration of Title VIII of the PHS Act, including the range of
issues relating to the nurse workforce, nursing education, and nursing
practice improvement, as a means of enhancing the health of the public
through the development of the nurse workforce. NACNEP meets at least
twice each calendar year or may meet more frequently 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 (SGE) on NACNEP to fill open
positions. The Secretary appoints NACNEP members with the expertise
needed to fulfill the duties of the Advisory Council. The membership
requirements are set forth at section 851(b) of Title VIII of the PHS
Act, as amended.
Nominees sought are individuals representing leading authorities in
the various fields of nursing, higher and secondary education, and
associate degree schools of nursing; representatives of advanced
education nursing groups (such as nurse practitioners, nurse midwives,
clinical nurse specialists, and nurse anesthetists); hospitals and
other institutions and organizations which provide nursing services;
practicing professional nurses; the general public; and full-time
students enrolled in schools of nursing. In making such appointments,
the Secretary shall ensure a fair balance between the nursing
specialties, a broad geographic representation of members, and a
balance between urban and rural members. Members shall be appointed
based on their competence, interest, and knowledge of the mission of
the profession involved. As required by PHS Act section 851(b)(3), the
Secretary shall ensure the adequate representation of minorities. HRSA
is particularly interested in seeking nominations from individuals who
can represent underrepresented groups in the nursing profession.
The majority of NACNEP members shall be nurses. Interested
applicants may self-nominate or be nominated by another individual or
organization.
Individuals selected for appointment to NACNEP will be invited to
serve a term of 4 years. Members appointed as SGEs receive a stipend
and reimbursement for per diem and travel expenses incurred for
attending NACNEP meetings and/or conducting other business on behalf of
NACNEP, as authorized by section 5 U.S.C. 5703 for persons employed
intermittently in government service and PHS Act section 762(g).
The following information must be included in the package of
materials submitted for each individual nominated for consideration:
(1) if nominated by another individual or organization, a letter of
nomination from the nominator stating the basis for the nomination
(i.e., what specific attributes, perspectives, and/or skills does the
individual possess that would benefit the workings of NACNEP, and the
nominee's field(s) of expertise), as well as the nominator's name,
affiliation, and contact information (address, daytime telephone
number, and email address); (2) letter of interest from the applicant
stating the reasons the applicant would like to serve on NACNEP; (3) a
biographical sketch of the applicant, including the applicant's
curriculum vitae and contact information (address, daytime telephone
number, and email address). Nomination packages may be submitted
directly by the applicant or by the person/organization nominating the
candidate.
HHS endeavors to ensure that the membership of NACNEP is balanced
fairly in terms of points of view represented. Appointments shall be
made without discrimination of age, race, ethnicity, gender, 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 NACNEP 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: NACNEP is authorized by section 851 of the PHS Act (42
U.S.C. 297t), as amended. NACNEP is governed by provisions of the
Federal Advisory Committee Act of 1972 (5 U.S.C. Chapter 10).
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2024-01396 Filed 1-24-24; 8:45 am]
BILLING CODE 4165-15-P
