83 FR 15162 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; NURSE Corps Loan Repayment Program, OMB #0915-0140-Revision
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 83, Issue 68 (April 9, 2018)
Health Resources and Services Administration
Federal Register Volume 83, Issue 68 (April 9, 2018)
| Page Range | 15162-15164 | |
| FR Document | 2018-07176 |
[Federal Register Volume 83, Number 68 (Monday, April 9, 2018)] [Notices] [Pages 15162-15164] From the Federal Register Online [www.thefederalregister.org] [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
![15162 Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
do not wish to be made available to the fdsys/pkg/FR-2015-09-18/pdf/2015- biological products. This draft guidance
public, submit the comment as a 23389.pdf. is intended to advance scientific
written/paper submission and in the Docket: For access to the docket to research in pregnant women, and
manner detailed (see ‘‘Written/Paper read background documents or the discusses issues that should be
Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments considered within the framework of
received, go to https:// human subject protection regulations.
Written/Paper Submissions www.regulations.gov and insert the This draft guidance is being issued
Submit written/paper submissions as docket number, found in brackets in the consistent with FDA’s good guidance
follows: heading of this document, into the practices regulation (21 CFR 10.115).
• Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts The draft guidance, when finalized, will
written/paper submissions): Dockets and/or go to the Dockets Management represent the current thinking of FDA
Management Staff (HFA–305), Food and Staff, 5630 Fishers Lane, Rm. 1061, on scientific and ethical considerations
Drug Administration, 5630 Fishers Rockville, MD 20852. for inclusion of pregnant women in
Lane, Rm. 1061, Rockville, MD 20852. You may submit comments on any clinical trials. It does not establish any
• For written/paper comments guidance at any time (see 21 CFR rights for any person and is not binding
submitted to the Dockets Management 10.115(g)(5)). on FDA or the public. You can use an
Staff, FDA will post your comment, as Submit written requests for single alternative approach if it satisfies the
well as any attachments, except for copies of the draft guidance to the requirements of the applicable statutes
information submitted, marked and Division of Drug Information, Center for and regulations. This guidance is not
identified, as confidential, if submitted Drug Evaluation and Research, Food subject to Executive Order 12866.
as detailed in ‘‘Instructions.’’ and Drug Administration, 10001 New
II. Electronic Access
Instructions: All submissions received Hampshire Ave., Hillandale Building,
must include the Docket No. FDA– 4th Floor, Silver Spring, MD 20993– Persons with access to the internet
2018–D–1201 for ‘‘Pregnant Women: 0002. Send one self-addressed adhesive may obtain the draft guidance at either
Scientific and Ethical Considerations for label to assist that office in processing https://www.fda.gov/Drugs/Guidance
Inclusion in Clinical Trials; Draft your requests. See the SUPPLEMENTARY ComplianceRegulatoryInformation/
Guidance; Availability.’’ Received INFORMATION section for electronic Guidances/default.htm or https://
comments will be placed in the docket access to the draft guidance document. www.regulations.gov.
and, except for those submitted as FOR FURTHER INFORMATION CONTACT: Dated: April 3, 2018.
‘‘Confidential Submissions,’’ publicly Denise Johnson-Lyles, Center for Drug Leslie Kux,
viewable at https://www.regulations.gov Evaluation and Research, Food and Associate Commissioner for Policy.
or at the Dockets Management Staff Drug Administration, 10903 New [FR Doc. 2018–07151 Filed 4–6–18; 8:45 am]
between 9 a.m. and 4 p.m., Monday Hampshire Ave., Bldg. 22, Rm. 6469, BILLING CODE 4164–01–P
through Friday. Silver Spring, MD 20993, 301–796–
• Confidential Submissions—To 6169.
submit a comment with confidential SUPPLEMENTARY INFORMATION: DEPARTMENT OF HEALTH AND
information that you do not wish to be HUMAN SERVICES
made publicly available, submit your I. Background
comments only as a written/paper FDA is announcing the availability of Health Resources and Services
submission. You should submit two a draft guidance for industry entitled Administration
copies total. One copy will include the ‘‘Pregnant Women: Scientific and
Agency Information Collection
information you claim to be confidential Ethical Considerations for Inclusion in
Activities: Submission to OMB for
with a heading or cover note that states Clinical Trials.’’ Currently, collection of
Review and Approval; Public Comment
‘‘THIS DOCUMENT CONTAINS safety data on prescription drugs and
Request; NURSE Corps Loan
CONFIDENTIAL INFORMATION.’’ The biological products used during
Repayment Program, OMB #0915–
Agency will review this copy, including pregnancy usually occurs after approval,
0140—Revision
the claimed confidential information, in and clinicians and patients must
its consideration of comments. The undertake a risk-benefit analysis for the AGENCY: Health Resources and Services
second copy, which will have the use of such products in pregnant Administration (HRSA), Department of
claimed confidential information women with limited human safety Health and Human Services.
redacted/blacked out, will be available information. Historically, pregnant ACTION: Notice.
for public viewing and posted on women have been an understudied
https://www.regulations.gov. Submit population and there have been barriers SUMMARY: In compliance with the
both copies to the Dockets Management to obtaining data from pregnant women Paperwork Reduction Act of 1995,
Staff. If you do not wish your name and in clinical trials, including concerns HRSA has submitted an Information
contact information to be made publicly about protecting women and their Collection Request (ICR) to the Office of
available, you can provide this fetuses from research-related risks. Management and Budget (OMB) for
information on the cover sheet and not However, data are needed to inform safe review and approval. Comments
in the body of your comments and you and effective treatment during submitted during the first public review
must identify this information as pregnancy, and in certain situations, it of this ICR will be provided to OMB.
‘‘confidential.’’ Any information marked OMB will accept further comments from
sradovich on DSK3GMQ082PROD with NOTICES
is ethically and scientifically
as ‘‘confidential’’ will not be disclosed appropriate to collect data in pregnant the public during the review and
except in accordance with 21 CFR 10.20 women in clinical trials conducted approval period.
and other applicable disclosure law. For during drug development. DATES: Comments on this ICR should be
more information about FDA’s posting This draft guidance discusses the received no later than May 9, 2018.
of comments to public dockets, see 80 ethical and scientific issues when ADDRESSES: Submit your comments,
FR 56469, September 18, 2015, or access considering the inclusion of pregnant including the ICR Title, to the desk
the information at: https://www.gpo.gov/ women in clinical trials of drugs and officer for HRSA, either by email to
VerDate Sep<11>2014 18:06 Apr 06, 2018 Jkt 244001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 E:\FR\FM\09APN1.SGM 09APN1](https://thefederalregister.org/doc/83_FR_15230/page/1.svg)
![15164 Federal Register / Vol. 83, No. 68 / Monday, April 9, 2018 / Notices
Dated: April 3, 2018. Advancement of Telehealth (OAT) in for their own internal program
Lori Roche, collaboration with the Telehealth management;
Acting Deputy Director, Division of the Resource Centers (TRCs) created a set of 5. Measure performance relative to the
Executive Secretariat. performance measures that grantees can mission of OAT/HRSA as well as
[FR Doc. 2018–07176 Filed 4–6–18; 8:45 am] use to evaluate the technical assistance individual goals and objectives of the
BILLING CODE 4165–15–P services provided by the TRCs. Grantee program;
goals are to provide customized
telehealth technical assistance across 6. Identify topics of interest for future
DEPARTMENT OF HEALTH AND the country. The TRCs provide technical special studies; and
HUMAN SERVICES assistance to health care organizations, 7. Identify changes in healthcare
health care networks and health care needs within rural communities,
Health Resources and Services providers in the implementation of cost- allowing programs to shift focus in
Administration effective telehealth programs to serve order to meet those needs.
rural and medically underserved areas
Agency Information Collection This renewal request proposes
and populations.
Activities: Proposed Collection: Public Need and Proposed Use of the changes to existing measures. After
Comment Request; Telehealth Information: In order to evaluate compiling data from the previous tool
Resource Center Performance existing programs, data are submitted to over the last three years, OAT
Measurement Tool, OMB No. 0915– OAT through HRSA’s Performance conducted an analysis of the data and
0361, Revision Improvement Management System compared the findings with the program
(PIMS). The data are used to measure needs. Based on the findings, the
AGENCY: Health Resources and Services measures are being revised to better
Administration (HRSA), Department of the effectiveness of the technical
assistance. There are two data reporting capture information necessary to
Health and Human Services. measure the effectiveness of the
periods each year; during these biannual
ACTION: Notice. program. The measure changes include:
reporting periods data are reported for
SUMMARY: In compliance with the the previous six months of activity. Additional demographic details from
requirement for opportunity for public Programs have approximately six weeks organizations requesting technical
comment on proposed data collection to enter their data into the PIMS system assistance, streamlined methods of
projects of the Paperwork Reduction Act during each biannual reporting period. inquiry, additional topics of technical
of 1995, HRSA announces plans to The instrument was developed with assistance inquiries aligning with the
submit an Information Collection the following four goals in mind: current telehealth landscape,
Request (ICR), described below, to the 1. Improving access to needed streamlined types of services provided
Office of Management and Budget services, by the grantees, deletion of client
2. reducing rural practitioner satisfaction survey results, and deletion
(OMB). Prior to submitting the ICR to
isolation, of telehealth sites developed as a result
OMB, HRSA seeks comments from the 3. improving health system
public regarding the burden estimate, of grantee technical assistance.
productivity and efficiency, and Likely Respondents: The likely
below, or any other aspect of the ICR. 4. improving patient outcomes.
DATES: Comments on this ICR must be The TRCs currently report on existing respondents will be telehealth
received no later than June 8, 2018. performance data elements using PIMS. associations, telehealth providers, rural
ADDRESSES: Submit your comments to The performance measures are designed health providers, clinicians that deliver
paperwork@hrsa.gov or mail Lisa to assess how the TRC program is services via telehealth, technical
Wright-Solomon, HRSA Information meeting its goals to: assistance providers, research
Collection Clearance Officer, Room 10– 1. Expand the availability of organizations, and academic medical
29, 5600 Fishers Lane, Rockville, MD telehealth services in underserved centers.
20857. communities, Burden Statement: Burden in this
2. Improve the quality, efficiency, and context means the time expended by
FOR FURTHER INFORMATION CONTACT: To
effectiveness of telehealth services, and persons to generate, maintain, retain,
request more information on the 3. Promote knowledge exchange and
proposed project or to obtain a copy of disclose or provide the information
dissemination about efficient and requested. This includes the time
the data collection plans and draft effective telehealth practices and
instruments, email Lisa Wright-Solomon needed to review instructions; to
technology. develop, acquire, install and utilize
at paperwork@hrsa.gov or call the HRSA 4. Establish sustainable technical
Information Collection Clearance Officer technology and systems for the purpose
assistance (TA) centers providing of collecting, validating and verifying
at (301) 443–1984. quality, unbiased TA for the information, processing and
SUPPLEMENTARY INFORMATION: When development and expansion of effective maintaining information, and disclosing
submitting comments or requesting and efficient telehealth services in and providing information; to train
information, please include the underserved communities. personnel and to be able to respond to
information request collection title for Additionally, the PIMS tool allows a collection of information; to search
reference. OAT to:
Information Collection Request Title: data sources; to complete and review
1. Determine the value added from the the collection of information; and to
Telehealth Resource Center Performance TRC Cooperative Agreement; transmit or otherwise disclose the
sradovich on DSK3GMQ082PROD with NOTICES
Measurement Tool, OMB No. 0915– 2. Justify budget requests;
0361, Revision. 3. Collect uniform, consistent data information. The total annual burden
Abstract: To ensure the best use of which enables OAT to monitor hours estimated for this ICR are
public funds and to meet the programs; summarized in the table below.
Government Performance Review Act 4. Provide guidance to grantees on Total Estimated Annualized burden
requirements, the Office for the important indicators to track over time hours:
VerDate Sep<11>2014 18:06 Apr 06, 2018 Jkt 244001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 E:\FR\FM\09APN1.SGM 09APN1](https://thefederalregister.org/doc/83_FR_15230/page/3.svg)
Document Created: 2018-04-07 02:39:27
Document Modified: 2018-04-07 02:39:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Comments on this ICR should be received no later than May 9, 2018. | |
| 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. | |
| FR Citation | 83 FR 15162 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR