Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; NURSE Corps Loan Repayment Program, OMB #0915-0140-Revision, 15162-15164 [2018-07176]
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Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
sradovich on DSK3GMQ082PROD with NOTICES
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2018–D–1201 for ‘‘Pregnant Women:
Scientific and Ethical Considerations for
Inclusion in Clinical Trials; Draft
Guidance; Availability.’’ Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
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fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Dockets Management
Staff, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.
You may submit comments on any
guidance at any time (see 21 CFR
10.115(g)(5)).
Submit written requests for single
copies of the draft guidance to the
Division of Drug Information, Center for
Drug Evaluation and Research, Food
and Drug Administration, 10001 New
Hampshire Ave., Hillandale Building,
4th Floor, Silver Spring, MD 20993–
0002. Send one self-addressed adhesive
label to assist that office in processing
your requests. See the SUPPLEMENTARY
INFORMATION section for electronic
access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT:
Denise Johnson-Lyles, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 22, Rm. 6469,
Silver Spring, MD 20993, 301–796–
6169.
biological products. This draft guidance
is intended to advance scientific
research in pregnant women, and
discusses issues that should be
considered within the framework of
human subject protection regulations.
This draft guidance is being issued
consistent with FDA’s good guidance
practices regulation (21 CFR 10.115).
The draft guidance, when finalized, will
represent the current thinking of FDA
on scientific and ethical considerations
for inclusion of pregnant women in
clinical trials. 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. This guidance is not
subject to Executive Order 12866.
SUPPLEMENTARY INFORMATION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
I. Background
FDA is announcing the availability of
a draft guidance for industry entitled
‘‘Pregnant Women: Scientific and
Ethical Considerations for Inclusion in
Clinical Trials.’’ Currently, collection of
safety data on prescription drugs and
biological products used during
pregnancy usually occurs after approval,
and clinicians and patients must
undertake a risk-benefit analysis for the
use of such products in pregnant
women with limited human safety
information. Historically, pregnant
women have been an understudied
population and there have been barriers
to obtaining data from pregnant women
in clinical trials, including concerns
about protecting women and their
fetuses from research-related risks.
However, data are needed to inform safe
and effective treatment during
pregnancy, and in certain situations, it
is ethically and scientifically
appropriate to collect data in pregnant
women in clinical trials conducted
during drug development.
This draft guidance discusses the
ethical and scientific issues when
considering the inclusion of pregnant
women in clinical trials of drugs and
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II. 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 or https://
www.regulations.gov.
Dated: April 3, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–07151 Filed 4–6–18; 8:45 am]
BILLING CODE 4164–01–P
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 #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 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.
DATES: Comments on this ICR should be
received no later than May 9, 2018.
ADDRESSES: Submit your comments,
including the ICR Title, to the desk
officer for HRSA, either by email to
SUMMARY:
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Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
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), including advanced
practice RNs (i.e., 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, by decreasing the financial
barriers associated with pursuing a
nursing profession. 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.
Need and Proposed Use of the
Information: The need and purpose of
this information collection is to obtain
information for NURSE Corps LRP
applicants and participants. HRSA uses
this information to consider an
applicant for a NURSE Corps LRP
contract award and to monitor a
participant’s compliance with the
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 semi-annual
employment verification form asks for
personal and employment information
to determine if a participant is in
compliance with the service
requirements.
This revision to the clearance package
will incorporate two new forms: (1) The
CSF Verification Form is used to verify
transfers to CSFs not already recorded
in the online portal; and (2) the NURSE
Corps Nurse Faculty Employment
Verification Form asks for personal and
employment information to specifically
Number of
respondents
Instrument
Responses/
respondent
determine if nurse faculty participants
are eligible to transfer to another
approved accredited school of nursing.
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 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:
The estimates of reporting burden for
Applicants are as follows:
Total
responses
Hours per
response
Total burden
hours
NURSE Corps LRP Application * .........................................
Authorization to Release Employment Information Form **
5,500
5,500
1
1
5,500
5,500
2.0
0.1
11,000
550
Total for Applicants .......................................................
5,500
........................
11,000
........................
11,550
* 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 reflected in the burden hours.
** The same respondents are completing these instruments.
The estimates of reporting burden for
participants are as follows:
Number of
respondents
Instrument
Responses/
respondent
Total
responses
Hours per
response
Total burden
hours
Participant Semi-Annual Employment Verification Form .....
NURSE Corps CSF Verification Form .................................
NURSE Corps Nurse Faculty Employment Verification
Form .................................................................................
2,300
550
2
1
4,600
550
0.5
0.1
2,300
55
250
1
250
0.2
50
Total for Participants .....................................................
3,100
4
5,400
.8
2,405
Total for Applicants and Participants ....................
8,600
........................
16,400
........................
* 13,955
sradovich on DSK3GMQ082PROD with NOTICES
* The 13,955 figure is a combination of burden hours for applicants and participants. This revision adds two forms (the CSF Verification Form
and NURSE Corps Nurse Faculty Employment Verification Form). Participants, not applicants, only use these forms. The 13,955 total burden
hours represents the net decrease in applicant burden, and the net increase in participant burden.
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15164
Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
Dated: April 3, 2018.
Lori Roche,
Acting Deputy Director, Division of the
Executive Secretariat.
[FR Doc. 2018–07176 Filed 4–6–18; 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; Telehealth
Resource Center Performance
Measurement Tool, OMB No. 0915–
0361, Revision
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 must be
received no later than June 8, 2018.
ADDRESSES: Submit your comments to
paperwork@hrsa.gov or mail Lisa
Wright-Solomon, HRSA Information
Collection Clearance Officer, Room 10–
29, 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 Lisa Wright-Solomon
at paperwork@hrsa.gov or call 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:
Telehealth Resource Center Performance
Measurement Tool, OMB No. 0915–
0361, Revision.
Abstract: To ensure the best use of
public funds and to meet the
Government Performance Review Act
requirements, the Office for the
sradovich on DSK3GMQ082PROD with NOTICES
SUMMARY:
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Advancement of Telehealth (OAT) in
collaboration with the Telehealth
Resource Centers (TRCs) created a set of
performance measures that grantees can
use to evaluate the technical assistance
services provided by the TRCs. Grantee
goals are to provide customized
telehealth technical assistance across
the country. The TRCs provide technical
assistance to health care organizations,
health care networks and health care
providers in the implementation of costeffective telehealth programs to serve
rural and medically underserved areas
and populations.
Need and Proposed Use of the
Information: In order to evaluate
existing programs, data are submitted to
OAT through HRSA’s Performance
Improvement Management System
(PIMS). The data are used to measure
the effectiveness of the technical
assistance. There are two data reporting
periods each year; during these biannual
reporting periods data are reported for
the previous six months of activity.
Programs have approximately six weeks
to enter their data into the PIMS system
during each biannual reporting period.
The instrument was developed with
the following four goals in mind:
1. Improving access to needed
services,
2. reducing rural practitioner
isolation,
3. improving health system
productivity and efficiency, and
4. improving patient outcomes.
The TRCs currently report on existing
performance data elements using PIMS.
The performance measures are designed
to assess how the TRC program is
meeting its goals to:
1. Expand the availability of
telehealth services in underserved
communities,
2. Improve the quality, efficiency, and
effectiveness of telehealth services, and
3. Promote knowledge exchange and
dissemination about efficient and
effective telehealth practices and
technology.
4. Establish sustainable technical
assistance (TA) centers providing
quality, unbiased TA for the
development and expansion of effective
and efficient telehealth services in
underserved communities.
Additionally, the PIMS tool allows
OAT to:
1. Determine the value added from the
TRC Cooperative Agreement;
2. Justify budget requests;
3. Collect uniform, consistent data
which enables OAT to monitor
programs;
4. Provide guidance to grantees on
important indicators to track over time
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Sfmt 4703
for their own internal program
management;
5. Measure performance relative to the
mission of OAT/HRSA as well as
individual goals and objectives of the
program;
6. Identify topics of interest for future
special studies; and
7. Identify changes in healthcare
needs within rural communities,
allowing programs to shift focus in
order to meet those needs.
This renewal request proposes
changes to existing measures. After
compiling data from the previous tool
over the last three years, OAT
conducted an analysis of the data and
compared the findings with the program
needs. Based on the findings, the
measures are being revised to better
capture information necessary to
measure the effectiveness of the
program. The measure changes include:
Additional demographic details from
organizations requesting technical
assistance, streamlined methods of
inquiry, additional topics of technical
assistance inquiries aligning with the
current telehealth landscape,
streamlined types of services provided
by the grantees, deletion of client
satisfaction survey results, and deletion
of telehealth sites developed as a result
of grantee technical assistance.
Likely Respondents: The likely
respondents will be telehealth
associations, telehealth providers, rural
health providers, clinicians that deliver
services via telehealth, technical
assistance providers, research
organizations, and academic medical
centers.
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:
E:\FR\FM\09APN1.SGM
09APN1
]]>Agencies
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)]
[Notices]
[Pages 15162-15164]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-07176]
-----------------------------------------------------------------------
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 #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
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.
DATES: Comments on this ICR should be received no later than May 9,
2018.
ADDRESSES: Submit your comments, including the ICR Title, to the desk
officer for HRSA, either by email to
[[Page 15163]]
[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), including advanced practice RNs (i.e., 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, by decreasing the financial
barriers associated with pursuing a nursing profession. 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.
Need and Proposed Use of the Information: The need and purpose of
this information collection is to obtain information for NURSE Corps
LRP applicants and participants. HRSA uses this information to consider
an applicant for a NURSE Corps LRP contract award and to monitor a
participant's compliance with the 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 semi-annual employment
verification form asks for personal and employment information to
determine if a participant is in compliance with the service
requirements.
This revision to the clearance package will incorporate two new
forms: (1) The CSF Verification Form is used to verify transfers to
CSFs not already recorded in the online portal; and (2) the NURSE Corps
Nurse Faculty Employment Verification Form asks for personal and
employment information to specifically determine if nurse faculty
participants are eligible to transfer to another approved accredited
school of nursing.
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 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:
The estimates of reporting burden for Applicants are as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
NURSE Corps LRP Application *... 5,500 1 5,500 2.0 11,000
Authorization to Release 5,500 1 5,500 0.1 550
Employment Information Form **.
-------------------------------------------------------------------------------
Total for Applicants........ 5,500 .............. 11,000 .............. 11,550
----------------------------------------------------------------------------------------------------------------
* 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 reflected in the
burden hours.
** The same respondents are completing these instruments.
The estimates of reporting burden for participants are as follows:
----------------------------------------------------------------------------------------------------------------
Number of Responses/ Total Hours per Total burden
Instrument respondents respondent responses response hours
----------------------------------------------------------------------------------------------------------------
Participant Semi-Annual 2,300 2 4,600 0.5 2,300
Employment Verification Form...
NURSE Corps CSF Verification 550 1 550 0.1 55
Form...........................
NURSE Corps Nurse Faculty 250 1 250 0.2 50
Employment Verification Form...
-------------------------------------------------------------------------------
Total for Participants...... 3,100 4 5,400 .8 2,405
-------------------------------------------------------------------------------
Total for Applicants and 8,600 .............. 16,400 .............. * 13,955
Participants...........
----------------------------------------------------------------------------------------------------------------
* The 13,955 figure is a combination of burden hours for applicants and participants. This revision adds two
forms (the CSF Verification Form and NURSE Corps Nurse Faculty Employment Verification Form). Participants,
not applicants, only use these forms. The 13,955 total burden hours represents the net decrease in applicant
burden, and the net increase in participant burden.
[[Page 15164]]
Dated: April 3, 2018.
Lori Roche,
Acting Deputy Director, Division of the Executive Secretariat.
[FR Doc. 2018-07176 Filed 4-6-18; 8:45 am]
BILLING CODE 4165-15-P
