Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: The Teaching Health Center Graduate Medical Education Program Reconciliation Tool, OMB No. 0915-0342-Extension, 27419-27420 [2020-09906]
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Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Notices
‘‘Cytomegalovirus in Transplantation:
Developing Drugs to Treat or Prevent
Disease.’’ The purpose of this final
guidance is to assist sponsors in the
clinical development of drugs to treat or
prevent CMV disease in patients who
have undergone SOT or HSCT.
Specifically, this guidance addresses
FDA’s current thinking regarding the
overall development program and
clinical trial designs for the
development of drugs and biological
products to support an indication for
treating or preventing CMV disease in
post-transplant populations. This
guidance does not address drug
development for treating or preventing
congenital CMV infection or CMV
infection in patients other than those
undergoing SOT or HSCT. This
guidance finalizes the draft guidance of
the same name issued on May 21, 2018
(83 FR 23463). Changes in this final
guidance compared with the previous
draft guidance include:
• Clarification of the use of CMV
DNAemia as a validated surrogate
endpoint for use in certain clinical
trials of CMV treatment or prevention
• Clarification that nonclinical
combination studies for drugs to be
used in combination are generally not
needed
• Inclusion of updated background
information to reflect the current
literature on preventing CMV in
transplant recipients
This guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The guidance represents the current
thinking of FDA on ‘‘Cytomegalovirus in
Transplantation: Developing Drugs to
Treat or Prevent Disease.’’ It does not
establish any rights for any person and
is not binding on FDA or the public.
You can use an alternative approach if
it satisfies the requirements of the
applicable statutes and regulations.
II. Paperwork Reduction Act of 1995
This guidance refers to previously
approved collections of information
found in FDA regulations. These
collections of information are subject to
review by the Office of Management and
Budget (OMB) under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501–
3520). The collections of information in
21 CFR parts 312, 314, and 601 have
been approved under OMB control
numbers 0910–0014, 0910–0001, and
0910–0038, respectively.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/drugs/guidance-
VerDate Sep<11>2014
17:46 May 07, 2020
Jkt 250001
compliance-regulatory-information/
guidances-drugs or https://
www.regulations.gov.
Dated: May 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09864 Filed 5–7–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5319]
Notice of Followup to Notice of Public
Hearing and Request for Comments on
Devices Proposed for a New Use With
an Approved, Marketed Drug
AGENCY:
Dated: May 1, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–09832 Filed 5–7–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Notice.
The Food and Drug
Administration (FDA, the Agency, or
we) is announcing a followup on a
Federal Register document issued on
September 26, 2017, that announced a
public hearing and requested comments
on a potential approach to enable device
sponsors to obtain marketing
authorization for their products labeled
for a new use with an approved,
marketed drug when the sponsor for the
approved drug does not wish to pursue
or collaborate on the new use, referred
to in the notice as devices referencing
drugs (DRDs). After further
consideration and in light of the
comments received, FDA does not
intend to pursue the potential approach
described in the referenced Federal
Register document at this time.
FOR FURTHER INFORMATION CONTACT: John
Barlow Weiner, Office of Combination
Products, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 32, Rm. 5130, Silver Spring,
MD 20993, 301–796–8941,
combination@fda.gov.
SUPPLEMENTARY INFORMATION: FDA
issued a Federal Register document on
September 26, 2017 (82 FR 44803),
entitled ‘‘Devices Proposed for a New
Use With an Approved, Marketed Drug;
Public Hearing; Request for Comments’’.
The document announced a public
hearing and requested comments on a
potential approach to enable device
sponsors to obtain marketing
authorization for their products labeled
for a new use with an approved,
marketed drug when the sponsor for the
approved drug does not wish to pursue
or collaborate on the new use. Such new
uses generally involve a change in how
SUMMARY:
PO 00000
the drug is used or administered, such
as a change in dose, route, or rate of
administration, or use of the approved
drug for an indication for which it is not
approved. As discussed in the
document, such DRDs raise unique
public health, scientific, regulatory, and
legal issues, which the potential
approach was intended to address.
However, after further consideration
and in light of the comments received
during the public hearing and submitted
to the docket, FDA does not intend to
pursue the potential approach described
in the document at this time.
Food and Drug Administration,
HHS.
ACTION:
27419
Frm 00068
Fmt 4703
Sfmt 4703
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Information Collection
Request Title: The Teaching Health
Center Graduate Medical Education
Program Reconciliation Tool, OMB No.
0915–0342—Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with of the
Paperwork Reduction Act of 1995,
HRSA has submitted an Information
Collection Request (ICR) to the Office of
Management and Budget (OMB) for
review and approval. Comments
submitted during the first public review
of this ICR will be provided to OMB.
OMB will accept further comments from
the public during the review and
approval period. OMB may act on
HRSA’s ICR only after the 30 day
comment period for this notice has
closed.
SUMMARY:
Comments on this ICR should be
received no later than June 8, 2020.
ADDRESSES: Written comments and
recommendations for the proposed
information collection should be sent
within 30 days of publication of this
notice to www.reginfo.gov/public/do/
PRAMain. Find this particular
information collection by selecting
‘‘Currently under Review—Open for
Public Comments’’ or by using the
search function.
DATES:
E:\FR\FM\08MYN1.SGM
08MYN1
27420
Federal Register / Vol. 85, No. 90 / Friday, May 8, 2020 / Notices
To
request a copy of the clearance requests
submitted to OMB for review, email Lisa
Wright-Solomon, the HRSA Information
Collection Clearance Officer at
paperwork@hrsa.gov or call (301) 443–
1984.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
The Teaching Health Center Graduate
Medical Education Program
Reconciliation Tool OMB No. 0915–
0342—Extension.
Abstract: The Teaching Health Center
Graduate Medical Education (THCGME)
program, authorized by Section 340H of
the Public Health Service Act, was
established by Section 5508 of Public
Law (Pub. L.) 111–148. The Bipartisan
Budget Act of 2018 (Pub. L. 115–123)
provided continued funding for the
THCGME Program for fiscal years 2018
and 2019 and the Further Continuing
Appropriations Act, 2020, and the
Coronavirus Aid, Relief, and Economic
Security (CARES) Act extends funding
for Fiscal Year (FY) 2020 for the first
two months of FY 2021 (until November
30, 2020).
THCGME program awards payment
for both direct and indirect expenses to
support training for primary care
residents in community-based
ambulatory patient care settings. Direct
medical expense payments are designed
to compensate eligible teaching health
centers for those expenses directly
associated with resident training, while
indirect medical expense payments are
intended to compensate for the
additional costs of training residents in
such programs.
A 60-day notice published in the
Federal Register on January 22, 2020,
Vol. 85, No. 14; pp. 3696–97. There
were no public comments.
Need and Proposed Use of the
Information: THCGME program
payments are prospective payments,
and the statute provides for a
reconciliation process, through which
overpayments may be recouped and
underpayments may be adjusted at the
end of the fiscal year. This data
collection instrument will gather
information relating to the number of
resident full-time equivalents in
Teaching Health Center training
programs in order to reconcile payments
for both direct and indirect expenses.
Likely Respondents: The likely
responders to the THCGME
Reconciliation Tool are THCGME
program award recipients.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install, and utilize
technology and systems for the purpose
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
TOTAL ESTIMATED ANNUALIZED BURDEN—HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Average
burden per
response
(in hours)
Total
responses
Total burden
hours
THCGME Reconciliation Tool ..............................................
58
1
58
2
116
Total ..............................................................................
58
........................
58
........................
116
Maria G. Button,
Director, Executive Secretariat.
applications, the disclosure of which
would constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2020–09906 Filed 5–7–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Heart, Lung, and Blood
Institute; 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
VerDate Sep<11>2014
17:46 May 07, 2020
Jkt 250001
Name of Committee: Heart, Lung, and
Blood Initial Review Group; NHLBI
Institutional Training Mechanism Review
Committee.
Date: June 4–5, 2020.
Time: 10:00 a.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Institutes of Health, RKL1
6705 Rockledge, Bethesda, MD 20892
(Telephone Conference Call).
Contact Person: Lindsay M. Garvin, Ph.D.,
Scientific Review Officer, Office of Scientific
Review/DERA, National Heart, Lung, and
Blood Institute, 6705 Rockledge Drive,
Bethesda, MD 20892, 301–827–7911,
lindsay.garvin@nih.gov.
(Catalogue of Federal Domestic Assistance
Program Nos. 93.233, National Center for
Sleep Disorders Research; 93.837, Heart and
Vascular Diseases Research; 93.838, Lung
Diseases Research; 93.839, Blood Diseases
and Resources Research, National Institutes
of Health, HHS)
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
Dated: May 5, 2020.
Ronald J. Livingston, Jr.,
Program Analyst, Office of Federal Advisory
Committee Policy.
[FR Doc. 2020–09920 Filed 5–7–20; 8:45 am]
BILLING CODE 4140–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
National Institute on Deafness and
Other Communication Disorders;
Notice of Closed Meetings
Pursuant to section 10(d) of the
Federal Advisory Committee Act, as
amended, notice is hereby given of the
following meetings.
The meetings 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
E:\FR\FM\08MYN1.SGM
08MYN1
]]>Agencies
[Federal Register Volume 85, Number 90 (Friday, May 8, 2020)]
[Notices]
[Pages 27419-27420]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-09906]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Submission to OMB for
Review and Approval; Public Comment Request; Information Collection
Request Title: The Teaching Health Center Graduate Medical Education
Program Reconciliation Tool, OMB No. 0915-0342--Extension
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with of the Paperwork Reduction Act of 1995,
HRSA has submitted an Information Collection Request (ICR) to the
Office of Management and Budget (OMB) for review and approval. Comments
submitted during the first public review of this ICR will be provided
to OMB. OMB will accept further comments from the public during the
review and approval period. OMB may act on HRSA's ICR only after the 30
day comment period for this notice has closed.
DATES: Comments on this ICR should be received no later than June 8,
2020.
ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to www.reginfo.gov/public/do/PRAMain. Find this particular
information collection by selecting ``Currently under Review--Open for
Public Comments'' or by using the search function.
[[Page 27420]]
FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance
requests submitted to OMB for review, email Lisa Wright-Solomon, the
HRSA Information Collection Clearance Officer at [email protected] or
call (301) 443-1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title: The Teaching Health Center
Graduate Medical Education Program Reconciliation Tool OMB No. 0915-
0342--Extension.
Abstract: The Teaching Health Center Graduate Medical Education
(THCGME) program, authorized by Section 340H of the Public Health
Service Act, was established by Section 5508 of Public Law (Pub. L.)
111-148. The Bipartisan Budget Act of 2018 (Pub. L. 115-123) provided
continued funding for the THCGME Program for fiscal years 2018 and 2019
and the Further Continuing Appropriations Act, 2020, and the
Coronavirus Aid, Relief, and Economic Security (CARES) Act extends
funding for Fiscal Year (FY) 2020 for the first two months of FY 2021
(until November 30, 2020).
THCGME program awards payment for both direct and indirect expenses
to support training for primary care residents in community-based
ambulatory patient care settings. Direct medical expense payments are
designed to compensate eligible teaching health centers for those
expenses directly associated with resident training, while indirect
medical expense payments are intended to compensate for the additional
costs of training residents in such programs.
A 60-day notice published in the Federal Register on January 22,
2020, Vol. 85, No. 14; pp. 3696-97. There were no public comments.
Need and Proposed Use of the Information: THCGME program payments
are prospective payments, and the statute provides for a reconciliation
process, through which overpayments may be recouped and underpayments
may be adjusted at the end of the fiscal year. This data collection
instrument will gather information relating to the number of resident
full-time equivalents in Teaching Health Center training programs in
order to reconcile payments for both direct and indirect expenses.
Likely Respondents: The likely responders to the THCGME
Reconciliation Tool are THCGME program award recipients.
Burden Statement: Burden in this context means the time expended by
persons to generate, maintain, retain, disclose or provide the
information requested. This includes the time needed to review
instructions; to develop, acquire, install, and utilize technology and
systems for the purpose of collecting, validating, and verifying
information, processing and maintaining information, and disclosing and
providing information; to train personnel and to be able to respond to
a collection of information; to search data sources; to complete and
review the collection of information; and to transmit or otherwise
disclose the information. The total annual burden hours estimated for
this ICR are summarized in the table below.
Total Estimated Annualized Burden--Hours
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
THCGME Reconciliation Tool...... 58 1 58 2 116
-------------------------------------------------------------------------------
Total....................... 58 .............. 58 .............. 116
----------------------------------------------------------------------------------------------------------------
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-09906 Filed 5-7-20; 8:45 am]
BILLING CODE 4165-15-P
