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Federal Register / Vol. 85, No. 26 / Friday, February 7, 2020 / Notices
approved under OMB control number
0910–0572.
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at either
https://www.fda.gov/Drugs/Guidance
ComplianceRegulatoryInformation/
Guidances/default.htm, http://
www.fda.gov/BiologicsBloodVaccines/
GuidanceComplianceRegulatory
Information/Guidances/default.htm, or
https://www.regulations.gov.
Dated: February 3, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–02421 Filed 2–6–20; 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: Nurse Faculty
Loan Program—Program Specific Data
Form and Annual Performance Report
Financial Data Form, OMB No. 0915–
0314—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 April 7, 2020.
ADDRESSES: Submit your comments to
[email protected] or mail the HRSA
Information Collection Clearance
Officer, 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 [email protected]
or call Lisa Wright-Solomon, the HRSA
Information Collection Clearance Officer
at (301) 443–1984.
SUPPLEMENTARY INFORMATION: When
submitting comments or requesting

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information, please include the ICR title
for reference.
Information Collection Request Title:
Nurse Faculty Loan Program—Program
Specific Data Form and Annual
Performance Report Financial Data
Form OMB No. 0915–0314—Revision.
Abstract: This clearance request is for
approval of both the Nurse Faculty Loan
Program (NFLP) Program Specific Data
Form and the Annual Performance
Report (APR) Financial Data Form. The
APR Financial Data Form is currently
approved under OMB Approval No.
0915–0314 and the Program Specific
Data Form is currently approved under
OMB Approval No. 0915–0378, both
with the expiration date of July 31,
2020. For program efficiency, HRSA is
combining these previously separate
ICRs under OMB No. 0915–0314 and
will be discontinuing OMB No. 0915–
0378.
Need and Proposed Use of the
Information: Section 846A of the Public
Health Service Act provides the
Secretary of HHS with the authority to
enter into an agreement with schools of
nursing for the establishment and
operation of a student loan fund to
increase the number of qualified nurse
faculty.
Under the agreement, HRSA makes
awards to the school for the NFLP loan
fund, which schools must maintain in a
distinct account. The school of nursing
makes loans from the NFLP account to
students enrolled full-time or, at the
discretion of the Secretary, part-time, in
a master’s or doctoral nursing education
program that will prepare them to
become qualified nursing faculty.
Following graduation from the NFLPlending school, loan recipients may
receive up to 85 percent NFLP loan
cancellation over a 4-year period in
exchange for service as full-time faculty
at a school of nursing. The NFLPlending school collects any portion of
the loan that it has not cancelled and
any loans that go into repayment due to
default and deposits these monies into
the NFLP loan fund to make additional
NFLP loans.
The NFLP Program Specific Data
Form is a required electronic attachment
within the NFLP application materials.
The data provided in the form is
essential for the formula-based criteria
used to determine the award amount to
the applicant schools. The form collects
application-related data from applicants
such as the amount requested, number
of students the school will fund, tuition
information, and projected unused loan
fund balance. Approval of the NFLP
Program Specific Data Form allows
HRSA to continue to capture data to
generate the formula-based awards for

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the NFLP program. This data collection
assists HRSA in streamlining the
application submission process,
enabling an efficient award
determination process, and facilitating
reporting on the use of funds and
analysis of program outcomes.
The NFLP–APR Financial Data Form
is an online form that exists in the
HRSA Electronic Handbooks
Performance Report module. The NFLP–
APR Financial Data Form collects
outcome and financial data to capture
the NFLP loan fund account activity
related to financial receivables,
disbursements, and borrower account
data related to employment status, loan
cancellation, loan repayment, and
collections. Participating schools
provide HHS with current and
cumulative information on: (1) NFLP
loan funds received, (2) number and
amount of NFLP loans made, (3) number
and amount of loans cancelled, (4)
number and amount of loans in
repayment, (5) loan default rate percent,
(6) number of NFLP graduates employed
as nurse faculty, and (7) other related
loan fund costs and activities.
The school of nursing must keep
records of all NFLP loan fund
transactions. HRSA uses the NFLP–APR
Financial Data Form to monitor grantee
performance by collecting information
related to the NFLP loan fund
operations and financial activities for a
specified reporting period (July 1
through June 30 of the academic year).
Participating schools are required to
complete and submit the NFLP–APR
Financial Data Form annually.
The data provided in the form is
essential for HRSA to monitor the
school’s use of NFLP funds in
accordance with the statute and
program guidelines. Approval of the
NFLP–APR Financial Data Form
extension will allow HRSA to continue
to monitor program performance and
program outcome.
Likely Respondents: Participating
NFLP schools and applicants to the
NFLP program.
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

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Federal Register / Vol. 85, No. 26 / Friday, February 7, 2020 / Notices

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

Total
responses

Average
burden per
response
(in hours)

Total burden
hours

Nurse Faculty Loan Program—Program Specific Data
Form .................................................................................
Nurse Faculty Loan Program—Annual Performance Report Financial Data Form .................................................

90

1

90

8

720

260

1

260

6

1,560

Total Burden .................................................................

350

........................

350

........................

2,280

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.

section 564 of the FD&C Act, subject to
the terms of any authorization issued
under that section.
DATES: The determination and
declaration took effect February 4, 2020.
FOR FURTHER INFORMATION CONTACT:
Robert P. Kadlec, M.D., MTM&H, MS,
Assistant Secretary for Preparedness
and Response, Office of the Secretary,
Department of Health and Human
Services, 200 Independence Avenue
SW, Washington, DC 20201, Telephone
(202) 205–2882 (this is not a toll free
number).

[FR Doc. 2020–02408 Filed 2–6–20; 8:45 am]

SUPPLEMENTARY INFORMATION:

BILLING CODE 4165–15–P

I. Background

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Office of the Secretary
Determination of Public Health
Emergency
Office of the Secretary,
Department of Health and Human
Services.
ACTION: Notice.
AGENCY:

The Secretary of Health and
Human Services (HHS) is issuing this
notice pursuant to section 564 of the
Federal Food, Drug, and Cosmetic
(FD&C) Act. On February 4, 2020, the
Secretary determined pursuant to his
authority under section 564 of the FD&C
Act that there is a public health
emergency that has a significant
potential to affect national security or
the health and security of United States
citizens living abroad and that involves
a novel (new) coronavirus (nCoV) first
detected in Wuhan City, Hubei
Province, China in 2019 (2019-nCoV).
On the basis of this determination, he
also declared that circumstances exist
justifying the authorization of
emergency use of in vitro diagnostics for
detection and/or diagnosis of this novel
coronavirus (2019-nCoV) pursuant to

SUMMARY:

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Under Section 564 of the FD&C Act,
21 U.S.C. 360bbb–3, the Commissioner
of the Food and Drug Administration
(FDA), acting under delegated authority
from the Secretary of HHS, may issue an
Emergency Use Authorization (EUA)
authorizing (1) the emergency use of an
unapproved drug, an unapproved or
uncleared device, or an unlicensed
biological product; or (2) an unapproved
use of an approved drug, approved or
cleared device, or licensed biological
product. Before an EUA may be issued,
the Secretary of HHS must declare that
circumstances exist justifying the
authorization based on one of four
determinations: (1) A determination by
the Secretary of Homeland Security that
there is a domestic emergency, or a
significant potential for a domestic
emergency, involving a heightened risk
of attack with a, chemical, biological,
radiological, or nuclear (‘‘CBRN’’) agent
or agents; (2) the identification of a
material threat by the Secretary of
Homeland Security pursuant to section
319F–2 of the Public Health Service
(PHS) Act 1 sufficient to affect national
security or the health and security of
United States citizens living abroad; (3)
a determination by the Secretary of
Defense that there is a military
1 42

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emergency, or a significant potential for
a military emergency, involving a
heightened risk to United States military
forces, including personnel operating
under the authority of title 10 or title 50,
of attack with (i) a biological, chemical,
radiological, or nuclear agent or agents;
or (ii) an agent or agents that may cause,
or are otherwise associated with, an
imminently life-threatening and specific
risk to United States military forces; or
(4) a determination by the Secretary that
there is a public health emergency, or a
significant potential for a public health
emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
United States citizens living abroad, and
that involves a CBRN agent or agents, or
a disease or condition that may be
attributable to such agent or agents.2
Based on any of these four
determinations, the Secretary of HHS
may then declare that circumstances
exist that justify the EUA, at which
point the FDA Commissioner may issue
an EUA if the criteria for issuance of an
authorization under section 564 of the
FD&C Act are met.
The determination of a public health
emergency, and the declaration that
circumstances exist justifying
emergency use of in vitro diagnostics for
detection and/or diagnosis of the novel
coronavirus (2019-nCoV) by the
Secretary of HHS, as described below,
enable the FDA Commissioner to issue
EUAs for certain in vitro diagnostics for
emergency use under section 564 of the
FD&C Act. The Centers for Disease
Control and Prevention (CDC) requested
that the FDA issue an EUA for its in
2 As amended by the Pandemic and All-Hazards
Preparedness Reauthorization Act, Public Law 113–
5, the Secretary may make determination of a public
health emergency, or a significant potential for a
public health emergency, under section 564 of the
FD&C Act. The Secretary is no longer required to
make a determination of a public health emergency
in accordance with section 319 of the PHS Act, 42
U.S.C. 247d to support a determination or
declaration made under section 564 of the FD&C
Act.

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