Agency Information Collection Activities: Proposed Collection: Public Comment Request: Information Collection Request Title: Bureau of Health Workforce Performance Data Collection, OMB No. 0915-0061-Revision, 52840-52841 [2018-22708]
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Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices
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begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
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 biological 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 biologic product AFSTYLA
(Antihemophilic Factor (Recombinant),
Single Chain). AFSTYLA is indicated in
children and adults with hemophilia A
(congenital Factor VIII deficiency) for:
(1) On-demand treatment and control of
bleeding episodes, (2) routine
prophylaxis to reduce the frequency of
bleeding episodes, and (3) perioperative
management of bleeding. Subsequent to
this approval, the USPTO received a
patent term restoration application for
AFSTYLA (U.S. Patent No. 7,041,635)
from SK Chemicals Co, LTD., and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
August 1, 2017, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
AFSTYLA represented the first
permitted commercial marketing or use
of the product. Thereafter, the USPTO
requested that FDA determine the
product’s regulatory review period.
II. Determination of Regulatory Review
Period
FDA has determined that the
applicable regulatory review period for
AFSTYLA is 1,734 days. Of this time,
1,371 days occurred during the testing
phase of the regulatory review period,
while 363 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: August 28, 2011. FDA
has verified the applicant’s claim that
the date the investigational new drug
application became effective was on
August 28, 2011.
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): May 29, 2015. FDA has
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verified the applicant’s claim that the
biologics license application (BLA) for
AFSTYLA (BLA 125591) was initially
submitted on May 29, 2015.
3. The date the application was
approved: May 25, 2016. FDA has
verified the applicant’s claim that BLA
125591 was approved on May 25, 2016.
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 1,047 days of patent
term extension.
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.
Dated: October 12, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–22696 Filed 10–17–18; 8:45 am]
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Health Resources and Services
Administration
Agency Information Collection
Activities: Proposed Collection: Public
Comment Request: Information
Collection Request Title: Bureau of
Health Workforce Performance Data
Collection, OMB No. 0915–0061—
Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
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 December 17,
2018.
SUMMARY:
III. Petitions
PO 00000
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Fmt 4703
Sfmt 4703
Submit your comments to
paperwork@hrsa.gov or mail the HRSA
Information Collection Clearance
Officer, Room 14N39, 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 Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting
information, please include the
information request collection title for
reference.
Information Collection Request Title:
Bureau of Health Workforce
Performance Data Collection, OMB No.
0915–0061—Revision.
Abstract: Over 40 Bureau of Health
Workforce (BHW) programs award
grants to health professions schools and
training programs across the United
States to develop, expand, and enhance
training, and to strengthen the
distribution of the health workforce.
These programs are governed by the
Public Health Service Act (42 U.S.C. 201
et seq.), specifically Titles III, VII, and
VIII. Performance information about
these health professions programs is
ADDRESSES:
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Federal Register / Vol. 83, No. 202 / Thursday, October 18, 2018 / Notices
collected in the HRSA Performance
Report for Grants and Cooperative
Agreements. Specific performance
measurement requirements for each
program may be found on the HRSA
website at https://bhw.hrsa.gov/grants/
reportonyourgrant. Data collection
activities consist of two reports, an
annual progress and annual
performance report that are submitted
by awardees to comply with statutory
and programmatic requirements for
performance measurement and
evaluation (including specific Title III,
VII and VIII requirements), as well as
the Government Performance and
Results Act of 1993 (GPRA) and the
GPRA Modernization Act of 2010
requirements. The performance
measures were last revised in 2016 to
ensure they addressed programmatic
changes, met evolving program
management needs, and responded to
emerging workforce concerns. As these
changes successfully enabled BHW to
demonstrate accurate outputs and
outcomes associated with the health
professions programs, BHW will
continue with its current performance
management strategy and make only
minor changes that reflect new HHS and
HRSA priorities with the addition of a
question asking awardees how many
trainees received training in telehealth,
substance use treatment, and/or
medication-assisted treatment.
Need and Proposed Use of the
Information: The purpose of the
proposed data collection is to continue
analysis and reporting of awardee
training activities and educational
programs, identify intended practice
locations, and report outcomes of
funded initiatives. Data collected from
these grant programs will also provide
a description of the program activities of
approximately 1,500 reporting grantees
to inform policymakers on the barriers,
opportunities, and outcomes involved
in health care workforce development.
The proposed measures focus on five
key outcomes: (1) Increasing the
workforce supply of well-educated
practitioners in needed professions; (2)
increasing the number of practitioners
that practice in underserved and rural
areas; (3) enhancing the quality of
education; (4) increasing the
recruitment, training, and placement of
under-represented groups in the health
workforce; and (5) supporting
educational infrastructure to increase
the capacity to train more health
professionals in high demand areas.
Likely Respondents: Respondents are
awardees of BHW health professions
grant programs.
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
Direct Financial Support Program .......................................
Infrastructure Program .........................................................
Multipurpose or Hybrid Program ..........................................
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.
Amy P. McNulty,
Acting Director, Division of the Executive
Secretariat.
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[FR Doc. 2018–22708 Filed 10–17–18; 8:45 am]
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Number of
responses per
respondent
500
100
900
3.1
4.5
4.3
1,550
450
3,870
1,500
........................
1,500
........................
5,870
Posting of the National Security
Presidential Memorandum 14,
‘‘Support for National Biodefense’’
Notice.
National Security Presidential
Memorandum 14 directs
implementation of the National
Biodefense Strategy. The Secretary is
authorized and directed to publish the
Memorandum in the Federal Register.
DATES: National Security Presidential
Memorandum 14 was signed on
September 18, 2018.
FOR FURTHER INFORMATION CONTACT:
Robert P. Kadlec, MD, MTM&H, MS,
Assistant Secretary for Preparedness
and Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SUMMARY:
Frm 00042
Total
burden
hours
1
1
1
Office of the Secretary
PO 00000
Average
burden per
response
(in hours)
500
100
900
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
ACTION:
Total
responses
Fmt 4703
Sfmt 4703
SW, Washington, DC 20201; Telephone:
202–205–2882.
SUPPLEMENTARY INFORMATION:
National Security Presidential
Memorandum: Support for National
Biodefense.
Memorandum for: The Vice President;
The Secretary of State; The Secretary of
the Treasury; The Secretary of Defense;
The Attorney General; The Secretary of
the Interior; The Secretary of
Agriculture; The Secretary of
Commerce; The Secretary of Labor; The
Secretary of Health and Human
Services; The Secretary of
Transportation; The Secretary of Energy;
The Secretary of Veterans Affairs; The
Secretary of Homeland Security;
Assistant to the President and Chief of
Staff; Administrator of the
Environmental Protection Agency;
Director of the Office of Management
and Budget; The Representative of the
United States to the United Nations;
Director of National Intelligence;
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]]>Agencies
[Federal Register Volume 83, Number 202 (Thursday, October 18, 2018)]
[Notices]
[Pages 52840-52841]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-22708]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration
Agency Information Collection Activities: Proposed Collection:
Public Comment Request: Information Collection Request Title: Bureau of
Health Workforce Performance Data Collection, OMB No. 0915-0061--
Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services (HHS).
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 December
17, 2018.
ADDRESSES: Submit your comments to [email protected] or mail the HRSA
Information Collection Clearance Officer, Room 14N39, 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 [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 information request collection title
for reference.
Information Collection Request Title: Bureau of Health Workforce
Performance Data Collection, OMB No. 0915-0061--Revision.
Abstract: Over 40 Bureau of Health Workforce (BHW) programs award
grants to health professions schools and training programs across the
United States to develop, expand, and enhance training, and to
strengthen the distribution of the health workforce. These programs are
governed by the Public Health Service Act (42 U.S.C. 201 et seq.),
specifically Titles III, VII, and VIII. Performance information about
these health professions programs is
[[Page 52841]]
collected in the HRSA Performance Report for Grants and Cooperative
Agreements. Specific performance measurement requirements for each
program may be found on the HRSA website at https://bhw.hrsa.gov/grants/reportonyourgrant. Data collection activities consist of two
reports, an annual progress and annual performance report that are
submitted by awardees to comply with statutory and programmatic
requirements for performance measurement and evaluation (including
specific Title III, VII and VIII requirements), as well as the
Government Performance and Results Act of 1993 (GPRA) and the GPRA
Modernization Act of 2010 requirements. The performance measures were
last revised in 2016 to ensure they addressed programmatic changes, met
evolving program management needs, and responded to emerging workforce
concerns. As these changes successfully enabled BHW to demonstrate
accurate outputs and outcomes associated with the health professions
programs, BHW will continue with its current performance management
strategy and make only minor changes that reflect new HHS and HRSA
priorities with the addition of a question asking awardees how many
trainees received training in telehealth, substance use treatment, and/
or medication-assisted treatment.
Need and Proposed Use of the Information: The purpose of the
proposed data collection is to continue analysis and reporting of
awardee training activities and educational programs, identify intended
practice locations, and report outcomes of funded initiatives. Data
collected from these grant programs will also provide a description of
the program activities of approximately 1,500 reporting grantees to
inform policymakers on the barriers, opportunities, and outcomes
involved in health care workforce development. The proposed measures
focus on five key outcomes: (1) Increasing the workforce supply of
well-educated practitioners in needed professions; (2) increasing the
number of practitioners that practice in underserved and rural areas;
(3) enhancing the quality of education; (4) increasing the recruitment,
training, and placement of under-represented groups in the health
workforce; and (5) supporting educational infrastructure to increase
the capacity to train more health professionals in high demand areas.
Likely Respondents: Respondents are awardees of BHW health
professions grant programs.
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
----------------------------------------------------------------------------------------------------------------
Direct Financial Support Program 500 1 500 3.1 1,550
Infrastructure Program.......... 100 1 100 4.5 450
Multipurpose or Hybrid Program.. 900 1 900 4.3 3,870
-------------------------------------------------------------------------------
1,500 .............. 1,500 .............. 5,870
----------------------------------------------------------------------------------------------------------------
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.
Amy P. McNulty,
Acting Director, Division of the Executive Secretariat.
[FR Doc. 2018-22708 Filed 10-17-18; 8:45 am]
BILLING CODE 4165-15-P
