Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Nurse Corps Loan Repayment Program, OMB No. 0915-0140 Revision, 5455-5456 [2020-01713]
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Federal Register / Vol. 85, No. 20 / Thursday, January 30, 2020 / Notices
In the Federal Register of July 12,
2018 (83 FR 32302), FDA announced the
availability of the draft guidance of the
same title. FDA received several
comments on the draft guidance and
those comments were considered as the
guidance was finalized. The guidance
announced in this notice finalizes the
draft guidance dated July 2018.
Elsewhere in this issue of the Federal
Register, FDA is announcing the
availability of two other human gene
therapy final guidance documents
entitled ‘‘Human Gene Therapy for
Hemophilia; Guidance for Industry’’ and
‘‘Human Gene Therapy for Rare
Diseases; Guidance for Industry.’’
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 ‘‘Human Gene
Therapy for Retinal Disorders.’’ 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.
khammond on DSKJM1Z7X2PROD with NOTICES
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–
3521). The collections of information in
21 CFR part 50 have been approved
under OMB control number 0910–0755;
the collections of information in 21 CFR
part 58 have been approved under OMB
control number 0910–0119; the
collections of information in 21 CFR
part 211 have been approved under
OMB control number 0910–0139; the
collections of information in 21 CFR
part 312 have been approved under
OMB control number 0910–0014; the
collections of information in 21 CFR
part 601 have been approved under
OMB control number 0910–0338; the
collections of information in the
guidance entitled ‘‘Expedited Programs
for Serious Conditions—Drugs and
Biologics’’ have been approved under
OMB control number 0910–0765; and
the collections of information in the
guidance entitled ‘‘Formal Meetings
Between the FDA and Sponsors or
Applicants’’ have been approved under
OMB control number 0910–0429.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at either
https://www.fda.gov/vaccines-bloodbiologics/guidance-compliance-
VerDate Sep<11>2014
16:56 Jan 29, 2020
Jkt 250001
regulatory-information-biologics or
https://www.regulations.gov.
Dated: January 27, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020–01703 Filed 1–29–20; 8:45 am]
BILLING CODE 4164–01–P
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; Nurse Corps Loan
Repayment Program, OMB No. 0915–
0140 Revision
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services.
ACTION: Notice.
AGENCY:
In compliance with the
Paperwork Reduction Act of 1995,
HRSA 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 March 2, 2020.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to (202) 395–5806.
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
paperwork@hrsa.gov or call (301) 443–
1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Nurse Corps Loan Repayment Program
OMB No. 0915–0140—Revision.
Abstract: The Nurse Corps Loan
Repayment Program (Nurse Corps LRP)
assists in the recruitment and retention
of professional Registered Nurses (RNs)
by decreasing the financial barriers
associated with pursuing a nursing
education. RNs in this instance include
advanced practice RNs (e.g., nurse
practitioners, certified registered nurse
DATES:
PO 00000
Frm 00089
Fmt 4703
Sfmt 4703
5455
anesthetists, certified nurse-midwives,
and clinical nurse specialists) dedicated
to working at eligible health care
facilities with a critical shortage of
nurses (i.e., a Critical Shortage Facility)
or working as nurse faculty in eligible,
accredited schools of nursing. The
Nurse Corps LRP provides loan
repayment assistance to these nurses to
repay a portion of their qualifying
educational loans in exchange for fulltime service at a public or private
nonprofit Critical Shortage Facility
(CSF) or in an eligible, accredited school
of nursing.
A 60-day notice was published in the
Federal Register on October, 10, 2019
vol. 84, No. 197; pp. 54617–51619.
Need and Proposed Use of the
Information: This information collection
is used by the Nurse Corps program to
make award decisions about Nurse
Corps LRP applicants and to monitor a
participant’s compliance with the
program’s service requirements.
Individuals must submit an application
in order to participate in the program.
The application asks for personal,
professional, educational, and financial
information required to determine the
applicant’s eligibility to participate in
the Nurse Corps LRP.
The revised information collection
request includes a new form and
updates to existing forms for the Nurse
Corps LRP in order to expand the
service options for awarded
participants, promote the use of
telehealth for delivering care throughout
the nation especially in rural areas, and
to reduce the application burden on
respondents.
New Form #1—Applicants will be
asked to submit a Disadvantaged
Background Form. This new form asks
the applicant’s site Point of Contact to
certify whether the applicant is from a
disadvantaged background. The form
provides eligibility criteria for the
determination.
Updated Form #1—The Participant
Semi-Annual Employment Verification
Form will be updated to include
additional information about the
participant’s service including
information about telehealth services
and whether they work at multiple CSF
sites. Telehealth helps expand the reach
of providers especially in rural areas
where medical service sites are more
remote. The information collected will
assist Program with determining the
impact and utilization of telehealth
services in various health care settings
which will be used to inform our
telehealth policies. Enabling multiple
CSF site service will also allow greater
flexibility for providers who rotate or
split time between multiple sites which
E:\FR\FM\30JAN1.SGM
30JAN1
5456
Federal Register / Vol. 85, No. 20 / Thursday, January 30, 2020 / Notices
benefits both the participants and the
underserved communities–especially in
our Federally Qualified Health Centers
which support many of our Nurse Corps
Nurse Practitioners.
Updated Form #2—The Nurse Corps
LRP application will include questions
for applicants to provide information
regarding telehealth services, multiple
CSF sites, and verification of base salary
to determine the debt to salary ratio
used to rank applicants for award
consideration. The application will also
be updated to identify applicants
eligible for Nurse Corps LRP psychiatric
nurse practitioner funding.
Likely Respondents: Professional RNs
or advanced practice RNs who are
interested in participating in the Nurse
Corps LRP and official representatives at
their service sites.
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
Number of
respondents
Form name
Number of
responses per
respondent
of collecting, validating, and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel 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: The estimates of reporting
burden for Applications are as follows:
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Nurse Corps LRP Application * ............................................
Authorization to Release Information Form * * .....................
Employment Verification Form * * .........................................
Disadvantaged Background Form .......................................
Confirmation of Interest Form ..............................................
7,100
7,100
7,100
450
500
1
1
1
1
1
7,100
7,100
7,100
450
500
2.00
.10
.10
.20
.20
14,200
710
710
90
100
Total for Applicants .......................................................
22,250
........................
22,250
........................
15,810
* The burden hours associated with this instrument account for both new and continuation applications. Additional (uploaded) supporting documentation is included as part of this instrument and is reflected in the burden hours.
* * The same respondents are completing these instruments.
The estimates of reporting for
Participants are as follows:
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
Participant Semi-Annual In Service Verification Form ........
Nurse Corps CSF Verification Form ....................................
Nurse Corps Nurse Faculty Employment Verification Form
500
500
450
2
1
1
1,000
500
450
.50
.10
.20
500
50
90
Total for Participants .....................................................
1,450
........................
1,950
........................
640
Total for Applicants and Participants ....................
23,700
........................
24,200
........................
* 16,450
* The 16,450 figure is the sum of total burden hours for applicants and participants. This revision adds an additional form (the Disadvantaged
Background Form).
Maria G. Button,
Director, Executive Secretariat.
provisions set forth in sections
552b(c)(4) and 552b(c)(6), Title 5 U.S.C.,
as amended. The grant applications
and/or contract proposals 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 and/or contract proposals,
the disclosure of which would
constitute a clearly unwarranted
invasion of personal privacy.
[FR Doc. 2020–01713 Filed 1–29–20; 8:45 am]
BILLING CODE 4165–15–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
khammond on DSKJM1Z7X2PROD with NOTICES
National Institutes of Health
National Cancer Institute; 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
VerDate Sep<11>2014
16:56 Jan 29, 2020
Jkt 250001
Name of Committee: National Cancer
Institute Special Emphasis Panel; TEP–12:
SBIR, Contract Review Meeting.
Date: March 3, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate contract
proposals.
PO 00000
Frm 00090
Fmt 4703
Sfmt 4703
Place: National Cancer Institute Shady
Grove, 9609 Medical Center Drive, Room
7W236, Rockville, MD 20850, (Telephone
Conference Call).
Contact Person: Robert Stephen Coyne,
Ph.D., Scientific Review Officer, National
Cancer Institute, NIH, Division of Extramural
Activities, Special Review Branch, 9609
Medical Center Drive, Room 7W236,
Rockville, MD 20850, 240–276–5120,
coyners@mail.nih.gov.
Name of Committee: National Cancer
Institute Special Emphasis Panel; NCI U01
Review.
Date: March 17, 2020.
Time: 1:00 p.m. to 5:00 p.m.
Agenda: To review and evaluate grant
applications.
Place: National Cancer Institute, Shady
Grove, 9609 Medical Center Drive, Room
7W514, Rockville, MD 20850, (Telephone
Conference Call).
E:\FR\FM\30JAN1.SGM
30JAN1
]]>Agencies
[Federal Register Volume 85, Number 20 (Thursday, January 30, 2020)]
[Notices]
[Pages 5455-5456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-01713]
-----------------------------------------------------------------------
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; Nurse Corps Loan Repayment
Program, OMB No. 0915-0140 Revision
AGENCY: Health Resources and Services Administration (HRSA), Department
of Health and Human Services.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In compliance with the Paperwork Reduction Act of 1995, HRSA
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 March 2,
2020.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to [email protected] or by
fax to (202) 395-5806.
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: Nurse Corps Loan Repayment
Program OMB No. 0915-0140--Revision.
Abstract: The Nurse Corps Loan Repayment Program (Nurse Corps LRP)
assists in the recruitment and retention of professional Registered
Nurses (RNs) by decreasing the financial barriers associated with
pursuing a nursing education. RNs in this instance include advanced
practice RNs (e.g., nurse practitioners, certified registered nurse
anesthetists, certified nurse-midwives, and clinical nurse specialists)
dedicated to working at eligible health care facilities with a critical
shortage of nurses (i.e., a Critical Shortage Facility) or working as
nurse faculty in eligible, accredited schools of nursing. The Nurse
Corps LRP provides loan repayment assistance to these nurses to repay a
portion of their qualifying educational loans in exchange for full-time
service at a public or private nonprofit Critical Shortage Facility
(CSF) or in an eligible, accredited school of nursing.
A 60-day notice was published in the Federal Register on October,
10, 2019 vol. 84, No. 197; pp. 54617-51619.
Need and Proposed Use of the Information: This information
collection is used by the Nurse Corps program to make award decisions
about Nurse Corps LRP applicants and to monitor a participant's
compliance with the program's service requirements. Individuals must
submit an application in order to participate in the program. The
application asks for personal, professional, educational, and financial
information required to determine the applicant's eligibility to
participate in the Nurse Corps LRP.
The revised information collection request includes a new form and
updates to existing forms for the Nurse Corps LRP in order to expand
the service options for awarded participants, promote the use of
telehealth for delivering care throughout the nation especially in
rural areas, and to reduce the application burden on respondents.
New Form #1--Applicants will be asked to submit a Disadvantaged
Background Form. This new form asks the applicant's site Point of
Contact to certify whether the applicant is from a disadvantaged
background. The form provides eligibility criteria for the
determination.
Updated Form #1--The Participant Semi-Annual Employment
Verification Form will be updated to include additional information
about the participant's service including information about telehealth
services and whether they work at multiple CSF sites. Telehealth helps
expand the reach of providers especially in rural areas where medical
service sites are more remote. The information collected will assist
Program with determining the impact and utilization of telehealth
services in various health care settings which will be used to inform
our telehealth policies. Enabling multiple CSF site service will also
allow greater flexibility for providers who rotate or split time
between multiple sites which
[[Page 5456]]
benefits both the participants and the underserved communities-
especially in our Federally Qualified Health Centers which support many
of our Nurse Corps Nurse Practitioners.
Updated Form #2--The Nurse Corps LRP application will include
questions for applicants to provide information regarding telehealth
services, multiple CSF sites, and verification of base salary to
determine the debt to salary ratio used to rank applicants for award
consideration. The application will also be updated to identify
applicants eligible for Nurse Corps LRP psychiatric nurse practitioner
funding.
Likely Respondents: Professional RNs or advanced practice RNs who
are interested in participating in the Nurse Corps LRP and official
representatives at their service sites.
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 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: The estimates of reporting
burden for Applications are as follows:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Nurse Corps LRP Application *... 7,100 1 7,100 2.00 14,200
Authorization to Release 7,100 1 7,100 .10 710
Information Form * *...........
Employment Verification Form * * 7,100 1 7,100 .10 710
Disadvantaged Background Form... 450 1 450 .20 90
Confirmation of Interest Form... 500 1 500 .20 100
-------------------------------------------------------------------------------
Total for Applicants........ 22,250 .............. 22,250 .............. 15,810
----------------------------------------------------------------------------------------------------------------
* The burden hours associated with this instrument account for both new and continuation applications.
Additional (uploaded) supporting documentation is included as part of this instrument and is reflected in the
burden hours.
* * The same respondents are completing these instruments.
The estimates of reporting for Participants are as follows:
----------------------------------------------------------------------------------------------------------------
Number of Average burden
Form name Number of responses per Total per response Total burden
respondents respondent responses (in hours) hours
----------------------------------------------------------------------------------------------------------------
Participant Semi-Annual In 500 2 1,000 .50 500
Service Verification Form......
Nurse Corps CSF Verification 500 1 500 .10 50
Form...........................
Nurse Corps Nurse Faculty 450 1 450 .20 90
Employment Verification Form...
-------------------------------------------------------------------------------
Total for Participants...... 1,450 .............. 1,950 .............. 640
-------------------------------------------------------------------------------
Total for Applicants and 23,700 .............. 24,200 .............. * 16,450
Participants...........
----------------------------------------------------------------------------------------------------------------
* The 16,450 figure is the sum of total burden hours for applicants and participants. This revision adds an
additional form (the Disadvantaged Background Form).
Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-01713 Filed 1-29-20; 8:45 am]
BILLING CODE 4165-15-P
