Solicitation of Nominations for Membership To Serve on the Council on Graduate Medical Education, 16994-16995 [2023-05782]
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Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
phase of the regulatory review period,
while 358 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 (21 U.S.C. 355(i))
became effective: July 29, 2010. FDA has
verified the applicant’s claim that the
date the investigational new drug
application became effective was on
July 29, 2010.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): February 27, 2018. FDA has
verified the applicant’s claim that the
biologics license application (BLA) for
ESPEROCT (BLA 125671) was initially
submitted on February 27, 2018.
3. The date the application was
approved: February 19, 2019. FDA has
verified the applicant’s claim that BLA
125671 was approved on February 19,
2019.
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 1,170 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
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.
VerDate Sep<11>2014
19:23 Mar 20, 2023
Jkt 259001
Dated: March 13, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–05658 Filed 3–20–23; 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 Council
on Graduate Medical Education
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
Council on Graduate Medical Education
(COGME or Council). COGME provides
advice and recommendations on policy,
program development, and other
matters of significance concerning the
physician training and the physician
workforce. Issues addressed by COGME
include the supply and distribution of
the physician workforce in the United
States, including any projected
shortages or excesses of physicians in
medical and surgical specialties and
subspecialities; international medical
graduates; the nature and financing of
undergraduate and graduate medical
education; appropriation levels for
certain programs under title VII of the
PHS Act; and deficiencies in databases
of the supply and distribution of the
physician workforce and postgraduate
programs for training physicians.
DATES: HRSA will accept nominations
on a continuous basis.
ADDRESSES: Nomination packages may
be mailed to Advisory Council
Operations, Bureau of Health
Workforce, HRSA, Room 15N–35, 5600
Fishers Lane, Rockville, Maryland
20857 or submitted electronically by
email to: BHWAdvisoryCouncilFRN@
hrsa.gov.
SUMMARY:
Curi
Kim, M.D., MPH, at 240–472–2313 or
email at ckim@hrsa.gov. A copy of the
current COGME charter, membership,
and reports can be obtained by
accessing the COGME website at https://
www.hrsa.gov/advisory-committees/
graduate-medical-edu.
SUPPLEMENTARY INFORMATION:
Authorized in 1986, COGME submits
advice and recommendations to the
Secretary of HHS; the Senate Committee
FOR FURTHER INFORMATION CONTACT:
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Fmt 4703
Sfmt 4703
on Health, Education, Labor and
Pensions; and the House of
Representatives Committee on Energy
and Commerce. Additionally, COGME
encourages entities providing graduate
medical education to voluntarily
achieve the recommendations of the
Council. Meetings take place at least
twice per year.
Nominations: HRSA is requesting
nominations for voting members to
serve as Special Government Employees
on COGME to include individuals who
represent of practicing primary care
physicians, national and specialty
physician organizations, international
medical graduates, medical student and
house staff associations, schools of
allopathic and osteopathic medicine,
public and private teaching hospitals,
and health insurers, business, and labor.
The Secretary of HHS appoints COGME
members to fulfill the duties of the
Council. Interested applicants may selfnominate or be nominated by another
individual or organization.
Individuals selected for appointment
to COGME will be invited to serve for
4 years. Members appointed as SGEs
receive a stipend and reimbursement for
per diem and travel expenses incurred
for attending COGME meetings and/or
conducting other business on behalf of
COGME, as authorized by section 5
U.S.C. 5703 for persons employed
intermittently in government service
and PHS Act section 762(g).
A nomination package should include
the following information for each
applicant: (1) if nominated by another
individual or organization, a letter of
recommendation 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 COGME) 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) a letter
of interest from the applicant stating the
reasons the applicant would like to
serve on COGME; and (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 COGME is balanced
fairly 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
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Federal Register / Vol. 88, No. 54 / Tuesday, March 21, 2023 / Notices
disabilities, are considered for
membership. Appointments shall be
made without discrimination on the
basis of age, race, ethnicity, gender,
sexual orientation, disability, and 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 Special
Government Employee’s public duties
as a member of COGME 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: PHS Act Section 762 (42
U.S.C. 294o), as amended. COGME is
governed by provisions of the Federal
Advisory Committee Act, as amended (5
U.S.C. 10), which sets forth standards
for the formation and use of advisory
committees and applies to the extent
that the provisions of the Federal
Advisory Committee Act do not conflict
with the requirements of PHS Act
section 762.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023–05782 Filed 3–20–23; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request: Information
Collection Request Title: Evaluation of
the Maternal and Child Health Bureau’s
Autism CARES Act Initiative, OMB No.
0915–0335–Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
ddrumheller on DSK120RN23PROD with NOTICES1
AGENCY:
In compliance with the
requirement for opportunity for public
comment on proposed data collection
projects of the Paperwork Reduction Act
of 1995, HRSA announces plans to
submit an information collection
request (ICR), described below, to the
Office of Management and Budget
(OMB). Prior to submitting the ICR to
SUMMARY:
VerDate Sep<11>2014
19:23 Mar 20, 2023
Jkt 259001
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR must be
received no later than May 22, 2023.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, MD 20857.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Samantha Miller, the HRSA
Information Collection Clearance
Officer, at 301–594–4394.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Evaluation of the Maternal and Child
Health Bureau’s Autism CARES Act
Initiative, OMB No. 0915–0335–
Revision.
Abstract: HRSA’s Maternal and Child
Health Bureau (MCHB) provides funds
to support several programs related to
autism, as authorized by 42 U.S.C. 280i–
1 (title III, section 399BB of the Public
Health Service Act), as amended by the
Autism Collaboration, Accountability,
Research, Education, and Support
(CARES) Act of 2019 (Pub. L. 116–60).
The Autism CARES Act of 2019
emphasizes improving health outcomes
and the well-being of individuals with
Autism Spectrum Disorder and
Developmental Disabilities across the
lifespan.
MCHB’s programs related to autism
fall within three distinct but
complementary areas—research, state
systems, and training. The awards
advance research on early screening and
interventions for autism and
developmental disabilities; improve the
capacity of state public health agencies
to build and maintain coordinated
systems of services for individuals with
autism and developmental disabilities;
and train the health care workforce to
screen, refer, and provide services for
children and youth with autism and
developmental disabilities. MCHB
currently funds 12 programs and 95
awardees. HRSA seeks to implement
annual comprehensive evaluations of
MCHB’s Autism CARES Initiative
investments.
This ICR is a revision to an existing
package; this study is the fifth
evaluation of HRSA’s autism activities
and employs similar data collection
methodologies as the prior studies.
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16995
Grantee interviews remain the primary
form of data collection. Minor proposed
revisions to the data collection process
include modifications to the interview
questions and grantee survey based on
the current legislation and HRSA’s
Notices of Funding Opportunity for
programs authorized under the Autism
CARES Act. In addition, the previous
data collection compiled survey
responses from all grantees, whereas
this revised data collection will only
seek survey responses from the Research
and State Systems grantees. The
previous data collection also included a
quantitative data collection form for the
Research grantees that the current data
collection will not collect. These
changes result in fewer burden hours
estimated across all primary data
collection activities.
Need and Proposed Use of the
Information: The purpose of this data
collection is to implement a
comprehensive evaluation that
describes the activities,
accomplishments, outcomes, barriers,
and challenges of the grant programs in
implementing the provisions of the
Autism CARES Act. The data will be
used to (1) conduct performance
monitoring of the programs; (2) provide
credible and rigorous evidence of
program effectiveness; (3) meet program
needs for accountability, decisionmaking, and quality assurance; and (4)
strengthen the evidence base for best
practices.
Likely Respondents: The survey
respondents will include Principal
Investigators/Project Directors from the
research programs and networks
(Autism Intervention Research Network
on Physical Health, Autism Intervention
Research Network on Behavioral Health,
MCHB Secondary Data Analysis
Research Program, Autism FieldInitiated Innovative Research Studies
Program, Autism Single Investigator
Innovation Program, the DevelopmentalBehavioral Pediatrics Research Network,
and the Healthy Weight Research
Network for Children with Autism and
Other Developmental Disabilities); and
state systems programs (State
Innovations) and coordinating center
(State Public Health Coordinating
Center for Autism). The respondents for
the interviews will include Principal
Investigators/Project Directors from the
research and state systems programs
above, and the training programs
(Leadership Education in
Neurodevelopmental and Related
Disabilities program, the Developmental
Behavioral Pediatrics program, and the
National Interdisciplinary Training
Resource Center).
E:\FR\FM\21MRN1.SGM
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]]>Agencies
[Federal Register Volume 88, Number 54 (Tuesday, March 21, 2023)]
[Notices]
[Pages 16994-16995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05782]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Solicitation of Nominations for Membership To Serve on the
Council on Graduate Medical Education
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 Council on Graduate
Medical Education (COGME or Council). COGME provides advice and
recommendations on policy, program development, and other matters of
significance concerning the physician training and the physician
workforce. Issues addressed by COGME include the supply and
distribution of the physician workforce in the United States, including
any projected shortages or excesses of physicians in medical and
surgical specialties and subspecialities; international medical
graduates; the nature and financing of undergraduate and graduate
medical education; appropriation levels for certain programs under
title VII of the PHS Act; and deficiencies in databases of the supply
and distribution of the physician workforce and postgraduate programs
for training physicians.
DATES: HRSA will accept nominations on a continuous basis.
ADDRESSES: Nomination packages may be mailed to Advisory Council
Operations, Bureau of Health Workforce, HRSA, Room 15N-35, 5600 Fishers
Lane, Rockville, Maryland 20857 or submitted electronically by email
to: [email protected].
FOR FURTHER INFORMATION CONTACT: Curi Kim, M.D., MPH, at 240-472-2313
or email at [email protected]. A copy of the current COGME charter,
membership, and reports can be obtained by accessing the COGME website
at https://www.hrsa.gov/advisory-committees/graduate-medical-edu.
SUPPLEMENTARY INFORMATION: Authorized in 1986, COGME submits advice and
recommendations to the Secretary of HHS; the Senate Committee on
Health, Education, Labor and Pensions; and the House of Representatives
Committee on Energy and Commerce. Additionally, COGME encourages
entities providing graduate medical education to voluntarily achieve
the recommendations of the Council. Meetings take place at least twice
per year.
Nominations: HRSA is requesting nominations for voting members to
serve as Special Government Employees on COGME to include individuals
who represent of practicing primary care physicians, national and
specialty physician organizations, international medical graduates,
medical student and house staff associations, schools of allopathic and
osteopathic medicine, public and private teaching hospitals, and health
insurers, business, and labor. The Secretary of HHS appoints COGME
members to fulfill the duties of the Council. Interested applicants may
self-nominate or be nominated by another individual or organization.
Individuals selected for appointment to COGME will be invited to
serve for 4 years. Members appointed as SGEs receive a stipend and
reimbursement for per diem and travel expenses incurred for attending
COGME meetings and/or conducting other business on behalf of COGME, as
authorized by section 5 U.S.C. 5703 for persons employed intermittently
in government service and PHS Act section 762(g).
A nomination package should include the following information for
each applicant: (1) if nominated by another individual or organization,
a letter of recommendation 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 COGME)
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) a letter of interest from the applicant
stating the reasons the applicant would like to serve on COGME; and (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 COGME is balanced
fairly 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
[[Page 16995]]
disabilities, are considered for membership. Appointments shall be made
without discrimination on the basis of age, race, ethnicity, gender,
sexual orientation, disability, and 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 Special
Government Employee's public duties as a member of COGME 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: PHS Act Section 762 (42 U.S.C. 294o), as amended. COGME
is governed by provisions of the Federal Advisory Committee Act, as
amended (5 U.S.C. 10), which sets forth standards for the formation and
use of advisory committees and applies to the extent that the
provisions of the Federal Advisory Committee Act do not conflict with
the requirements of PHS Act section 762.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2023-05782 Filed 3-20-23; 8:45 am]
BILLING CODE 4165-15-P
