Agency Information Collection Activities: Proposed Collection: Public Comment Request Information Collection Request Title: The Teaching Health Center Graduate Medical Education (THCGME) Program Reconciliation Tool, OMB No. 0915-0342-Extension, 3696-3697 [2020-00986]
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3696
Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Notices
approval of MAVYRET represented the
first permitted commercial marketing or
use of the product. Thereafter, the
USPTO requested that FDA determine
the product’s regulatory review period.
khammond on DSKJM1Z7X2PROD with NOTICES
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
MAVYRET is 1,725 days. Of this time,
1,492 days occurred during the testing
phase of the regulatory review period,
while 233 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: November 14,
2012. FDA has verified the applicant’s
claim that the date the investigational
new drug applications became effective
was on November 12, 2012.
2. The date the application was
initially submitted with respect to the
human drug product under section
505(b) of the FD&C Act: December 14,
2016. FDA has verified the applicant’s
claim that the new drug application
(NDA) for MAVYRET (NDA 209394)
was initially submitted on December 14,
2016.
3. The date the application was
approved: August 3, 2017. FDA has
verified the applicant’s claim that NDA
209394 was approved on August 3,
2017.
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 applications for patent extension,
this applicant seeks 0 days or 150 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
VerDate Sep<11>2014
16:42 Jan 21, 2020
Jkt 250001
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: January 15, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–00936 Filed 1–21–20; 8:45 am]
BILLING CODE 4164–01–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: The Teaching
Health Center Graduate Medical
Education (THCGME) 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 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
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 23, 2020.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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 Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
SUMMARY:
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Frm 00093
Fmt 4703
Sfmt 4703
information, please include the ICR title
for reference.
Information Collection Request Title:
The Teaching Health Center Graduate
Medical Education (THCGME) Program
Reconciliation Tool OMB No. 0915–
0342—Extension.
Abstract: The 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 Consolidated
Appropriations Act, 2020 (Pub. L. 116–
94) extends funding for the THCGME
program until May 22, 2020.
The 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 THC 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.
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 gathers
information relating to the number of
resident full-time equivalents in THC
training programs in order to reconcile
payments for both direct and indirect
expenses.
Likely Respondents: 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.
E:\FR\FM\22JAN1.SGM
22JAN1
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Federal Register / Vol. 85, No. 14 / Wednesday, January 22, 2020 / Notices
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
THCGME Reconciliation Tool ..............................................
58
1
58
2
116
Total ..............................................................................
58
........................
58
........................
116
HRSA specifically requests comments
on (1) the necessity and utility of the
proposed information collection for the
proper performance of the agency’s
functions, (2) the accuracy of the
estimated burden, (3) ways to enhance
the quality, utility, and clarity of the
information to be collected, and (4) the
use of automated collection techniques
or other forms of information
technology to minimize the information
collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020–00986 Filed 1–21–20; 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: Advanced
Nursing Education Workforce (ANEW),
OMB No. 0915–0375 Extension
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
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
OMB, HRSA seeks comments from the
public regarding the burden estimate,
below, or any other aspect of the ICR.
DATES: Comments on this ICR should be
received no later than March 23, 2020.
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
SUMMARY:
khammond on DSKJM1Z7X2PROD with NOTICES
Number of
responses per
respondent
VerDate Sep<11>2014
16:42 Jan 21, 2020
Jkt 250001
proposed project or to obtain a copy of
the data collection plans and draft
instruments, email paperwork@hrsa.gov
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the ICR title
for reference.
Information Collection Request Title:
Advanced Nursing Education Workforce
(ANEW) Program-Specific Data
Collection Forms OMB No. 0915–
0375—Extension.
Abstract: HRSA provides advanced
education nursing training grants to
educational institutions to increase the
numbers of advanced education nurses
through the ANEW Program. The ANEW
Program is authorized by Section 811 of
the Public Health Service Act (42 U.S.C.
296j), as amended. This request is to
extend the use of ANEW ProgramSpecific forms, specifically Tables #1
and #2. There are no proposed changes
to these tables.
ANEW Table #1 collects information
on the types of practice settings where
graduates, who received ANEW support
as students, are currently employed.
The data on graduates’ employment
practice settings demonstrate the
distribution of specialties, i.e., nurse
practitioners, clinical nurse specialists
and nurse midwives, who are practicing
in rural, underserved, public health
nursing, and Health Professional
Shortage Areas (HPSA) practice settings.
ANEW Table #2 requests information on
the projected number of primary care
advanced practice registered nursing
student enrollees/trainees who will
receive traineeship support for each
upcoming budget year over the entire
project period. This data provides a
baseline for comparison to data
collected on the numbers of students/
enrollees/trainees supported that are
reported on the Annual Performance
Reports.
Need and Proposed Use of the
Information: ANEW Program-Specific
Table #1 captures data on the number of
graduates of the academic partner
applicant who received HRSA support
and are currently employed in rural
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Fmt 4703
Sfmt 4703
areas, undeserved areas, public health
nursing, and HPSA practice settings.
The graduate data collected measure the
impact of the ANEW Program in
meeting the legislative and program
goals. ANEW Program-Specific Table #2
collects information on the projected
number of students/enrollees to receive
traineeship support each budget year of
the project period and provides a
baseline for student/enrollee support
that is reported in the Annual
Performance Reports. Collecting this
data assists HRSA in carrying out the
most impactful program and ensuring
resources are used responsibly.
Likely Respondents: Likely
respondents will be current ANEW
awardees, who will submit the data
tables as part of a Noncompeting
Continuation progress report, and
applicants for the ANEW program,
including schools of nursing, nursing
centers, academic health centers, state
or local governments, and other public
or private nonprofit entities determined
appropriate by the Secretary that are
accredited to carry out primary care
nurse practitioner and nurse midwifery
programs by a national nurse education
accrediting agency recognized by the
Secretary of the U.S. Department of
Education. The school must be located
in one of the 50 U.S. States, the District
of Columbia, Guam, the Commonwealth
of Puerto Rico, the Northern Mariana
Islands, the Virgin Islands, American
Samoa, the U.S. Virgin Islands, the
Federated States of Micronesia, the
Republic of the Marshall Islands, or the
Republic of Palau.
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
E:\FR\FM\22JAN1.SGM
22JAN1
]]>Agencies
[Federal Register Volume 85, Number 14 (Wednesday, January 22, 2020)]
[Notices]
[Pages 3696-3697]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-00986]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request Information Collection Request Title: The
Teaching Health Center Graduate Medical Education (THCGME) 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 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 OMB, HRSA seeks comments from the
public regarding the burden estimate, below, or any other aspect of the
ICR.
DATES: Comments on this ICR should be received no later than March 23,
2020.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N136B, 5600 Fishers
Lane, Rockville, Maryland 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 [email protected] or call Lisa Wright-
Solomon, the HRSA Information Collection Clearance Officer at (301)
443-1984.
SUPPLEMENTARY INFORMATION: When submitting comments or requesting
information, please include the ICR title for reference.
Information Collection Request Title: The Teaching Health Center
Graduate Medical Education (THCGME) Program Reconciliation Tool OMB No.
0915-0342--Extension.
Abstract: The 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 Consolidated Appropriations Act, 2020
(Pub. L. 116-94) extends funding for the THCGME program until May 22,
2020.
The 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 THC 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.
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 gathers information relating to the number of resident full-
time equivalents in THC training programs in order to reconcile
payments for both direct and indirect expenses.
Likely Respondents: 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.
[[Page 3697]]
Total Estimated Annualized Burden Hours
----------------------------------------------------------------------------------------------------------------
Average
Number of Number of Total burden per Total burden
Form name respondents responses per responses response (in hours
respondent hours)
----------------------------------------------------------------------------------------------------------------
THCGME Reconciliation Tool...... 58 1 58 2 116
-------------------------------------------------------------------------------
Total....................... 58 .............. 58 .............. 116
----------------------------------------------------------------------------------------------------------------
HRSA specifically requests comments on (1) the necessity and
utility of the proposed information collection for the proper
performance of the agency's functions, (2) the accuracy of the
estimated burden, (3) ways to enhance the quality, utility, and clarity
of the information to be collected, and (4) the use of automated
collection techniques or other forms of information technology to
minimize the information collection burden.
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-00986 Filed 1-21-20; 8:45 am]
BILLING CODE 4165-15-P
