Center for Scientific Review; Notice of Closed Meeting, 19157-19158 [2023-06639]
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Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Notices
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.
Dated: March 23, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023–06580 Filed 3–29–23; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Exemption of the Advanced Research
Projects Agency for Health (ARPA–H)
From Policies and Requirements of the
National Institutes of Health (NIH)
Advanced Research Projects
Agency for Health, Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
The Secretary of the U.S.
Department of Health and Human
Services (HHS) has statutory authority
to exempt the Advanced Research
Projects Agency for Health (ARPA–H)
from certain policies and requirements
of the National Institutes of Health
(NIH) as necessary and appropriate to
ensure ARPA–H can most effectively
achieve its statutorily specified goals.
Pursuant to such authority, and for the
reasons stated herein, the Secretary is
giving notice that he intends to exempt
ARPA–H from all NIH policies and
requirements subject to the limitations
and condition stated herein.
FOR FURTHER INFORMATION CONTACT:
Thomas Libert, 240–731–3874,
tom.libert@arpa-h.gov.
SUPPLEMENTARY INFORMATION: This
notice follows 87 FR 32174, published
on May 24, 2022. The Consolidated
Appropriations Act, 2023 (Public Law
117–328, enacted on December 29,
2022) includes authorizing language for
ARPA–H. Notably, section 499A of the
Public Health Service Act (PHSA), as
added by section 2331(a) of the
Consolidated Appropriations Act, 2023,
establishes ARPA–H within NIH and
provides that the Director, ARPA–H,
shall report to the Secretary of HHS.
Subparagraph (A) of section
499A(a)(3) provides that the Secretary
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may exempt ARPA–H from NIH policies
and requirements that are in effect on
the day before the enactment of section
499A as necessary and appropriate to
ensure ARPA–H can most effectively
achieve its statutorily specified goals,
except as otherwise provided for in
section 499A and subject to the
requirements of subparagraph (B).
Subparagraph (B) of section 499A(a)(3)
provides that not later than 90 days after
the date of enactment of section 499A,
the Secretary shall publish a notice in
the Federal Register describing the
specific NIH policies and requirements
from which the Secretary intends to
exempt ARPA–H, including a rationale
for such exemptions.
Pursuant to section 499A(a)(3) of the
PHSA, notice is hereby given that I
intend to exempt ARPA–H from all
policies and requirements of the NIH
that were in effect on the day before the
enactment of section 499A, that is, on
December 28, 2022.
The exemption is necessary and
appropriate to ensure ARPA–H can most
effectively achieve its statutorily
specified goals and consistent with prior
actions for the following reasons:
• The mission of ARPA–H is
complementary to NIH, but its business
model is distinct and separate. To
succeed at its mission to realize
transformative health solutions, ARPA–
H must establish a unique culture and
distinct and separate business and
operations processes, including its own
policies and requirements.
• On April 15, 2022, I transferred
ARPA–H to NIH as authorized by title
II of division H of the Consolidated
Appropriations Act, 2022 (Pub. L. 117–
103, enacted on March 15, 2022) and
delegated to the Director, NIH, certain
authorities for the purpose of carrying
out ARPA–H (87 FR 23526). As a
condition of the delegation, I specified
that NIH may not subject ARPA–H to
NIH policies.
• As noted, section 499A of the PHSA
establishes ARPA–H within NIH and
provides that the Director, ARPA–H,
shall report to the Secretary. In the Joint
Explanatory Statement (168 Cong. Rec.
S8895, 2022), Congress signaled its
intent for ARPA–H to establish its own
culture, procedures, and policies:
The agreement strongly encourages HHS to
collaborate with the Defense Advanced
Research Projects Agency (DARPA) to
develop the foundational policies,
procedures, and staff training for ARPA–H
employees. The agreement believes ARPA–H
will require a very different culture and
mission than NIH’s other 27 Institutes and
Centers.
ARPA–H shall continue to be subject
to all policies and requirements of HHS.
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19157
All major policy, programmatic, and
operational decisions proposed by
ARPA–H shall continue to come to the
Secretary for approval.
The exemption is subject to the
following condition:
• Where ARPA–H identifies a need to
develop a policy or requirement to
fulfill its mission, it shall rely upon NIH
policies and requirements until such
time as ARPA–H develops its own
policies and requirements as
appropriate.
Xavier Becerra,
Secretary of Health and Human Services.
[FR Doc. 2023–06620 Filed 3–29–23; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of
Closed Meeting
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meeting.
The meeting will be closed to the
public in accordance with the
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications and
the discussions could disclose
confidential trade secrets or commercial
property such as patentable material,
and personal information concerning
individuals associated with the grant
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
Name of Committee: Center for Scientific
Review Special Emphasis Panel;
Fellowships: Oncology.
Date: April 27, 2023.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health,
Rockledge II, 6701 Rockledge Drive,
Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Nywana Sizemore, Ph.D.,
Scientific Review Officer, Center for
Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6189,
MSC 7804, Bethesda, MD 20892, 301–408–
9916, sizemoren@csr.nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.306, Comparative Medicine;
93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393–93.396, 93.837–93.844,
93.846–93.878, 93.892, 93.893, National
Institutes of Health, HHS)
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19158
Federal Register / Vol. 88, No. 61 / Thursday, March 30, 2023 / Notices
Dated: March 27, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2023–06639 Filed 3–29–23; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Proposed Collection; 60-Day Comment
Request; Application Process for
Clinical Research Training and Medical
Education at the Clinical Center and Its
Impact on Course and Training
Program Enrollment and Effectiveness
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
requirement of the Paperwork
Reduction Act of 1995, for opportunity
for public comment on proposed data
collection projects, the National
Institutes of Health Clinical Center (CC)
will publish periodic summaries of
proposed projects to be submitted to the
Office of Management and Budget
(OMB) for review and approval.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 60 days of the date of this
publication.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
To
obtain a copy of the data collection
Education at the NIH Clinical Center
and Its impact on Course and Training
Program Enrollment and Effectiveness,
0925–0698, REVISION, Exp., date
August 31, 2023, National Institutes of
Health Clinical Center (CC), National
Institutes of Health (NIH).
Need and Use of Information
Collection: The primary objective of the
application process is to allow the
Office of Clinical Research Training and
Medical Education (OCRTME) at the
NIH Clinical Center to evaluate
applicants’ qualifications to determine
applicants’ eligibility for training
programs managed by the Office.
Applicants must provide the required
information requested in the respective
applications to be considered a
candidate for participation. Information
submitted by candidates for training
programs is reviewed initially by
OCRTME administrative staff to
establish eligibility for participation.
Eligible candidates are then referred to
the designated training program
director/administrator or training
program selection committee for review
and decisions regarding acceptance for
participation. Upon acceptance,
OCRTME will collect required eligibility
documents for respective training
programs. A secondary objective of the
application process is to track
enrollment in training programs over
time.
OMB approval is requested for 3
years. There are no costs to respondents
other than their time. The total
estimated annualized burden hours 433.
plans and instruments, contact: Tom
Burklow, MD, Office of Clinical
Research Training and Medical
Education, NIH Clinical Center,
National Institutes of Health, 10 Center
Drive, Room 1N262, Bethesda, MD
20892–1158, or call non-toll-free
number 301–435–8015, or email your
request, including your address to:
tom.burklow@nih.gov. Formal requests
for additional plans and instruments
must be requested in writing.
SUPPLEMENTARY INFORMATION: Section
3506(c)(2)(A) of the Paperwork
Reduction Act of 1995 requires: written
comments and/or suggestions from the
public and affected agencies are invited
to address one or more of the following
points: (1) Whether the proposed
collection of information is necessary
for the proper performance of the
function of the agency, including
whether the information will have
practical utility; (2) The accuracy of the
agency’s estimate of the burden of the
proposed collection of information,
including the validity of the
methodology and assumptions used; (3)
Ways to enhance the quality, utility, and
clarity of the information to be
collected; and (4) Ways to minimizes
the burden of the collection of
information on those who are to
respond, including the use of
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Proposed Collection Title:
Application Process for Clinical
Research Training and Medical
ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Average
burden per
response
(in hours)
Number of
responses per
respondent
Type of respondents
Clinical Electives Program ................
Graduate Medical Education ............
Medical Research Scholars Program
Resident Electives Program .............
Bioethics Fellowship Program ..........
OCRTME Onboarding Application ....
Pre Doctoral Students ......................
Physicians ........................................
Pre Doctoral Students ......................
Physicians ........................................
Pre Doctoral, Post-Doctoral .............
Pre Doctoral Students ......................
300
100
200
100
300
300
1
1
1
1
1
1
20/60
20/60
20/60
20/60
20/60
20/60
100
33
67
33
100
100
Total ...........................................
...........................................................
........................
1,300
........................
433
Dated: March 21, 2023.
Frederick D. Vorck, Jr.,
Project Clearance Liaison, NIH Clinical
Center, National Institutes of Health.
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Total annual
burden hours
Form name
[FR Doc. 2023–06641 Filed 3–29–23; 8:45 am]
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]]>Agencies
[Federal Register Volume 88, Number 61 (Thursday, March 30, 2023)]
[Notices]
[Pages 19157-19158]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-06639]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Center for Scientific Review; Notice of Closed Meeting
Pursuant to section 10(d) of the Federal Advisory Committee Act, as
amended, notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the
provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5
U.S.C., as amended. The grant applications and the discussions could
disclose confidential trade secrets or commercial property such as
patentable material, and personal information concerning individuals
associated with the grant applications, the disclosure of which would
constitute a clearly unwarranted invasion of personal privacy.
Name of Committee: Center for Scientific Review Special Emphasis
Panel; Fellowships: Oncology.
Date: April 27, 2023.
Time: 10:00 a.m. to 6:00 p.m.
Agenda: To review and evaluate grant applications.
Place: National Institutes of Health, Rockledge II, 6701
Rockledge Drive, Bethesda, MD 20892 (Virtual Meeting).
Contact Person: Nywana Sizemore, Ph.D., Scientific Review
Officer, Center for Scientific Review, National Institutes of
Health, 6701 Rockledge Drive, Room 6189, MSC 7804, Bethesda, MD
20892, 301-408-9916, [email protected].
(Catalogue of Federal Domestic Assistance Program Nos. 93.306,
Comparative Medicine; 93.333, Clinical Research, 93.306, 93.333,
93.337, 93.393-93.396, 93.837-93.844, 93.846-93.878, 93.892, 93.893,
National Institutes of Health, HHS)
[[Page 19158]]
Dated: March 27, 2023.
Miguelina Perez,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2023-06639 Filed 3-29-23; 8:45 am]
BILLING CODE 4140-01-P
