Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation OMB No. 0906-0034 − Revision, 55464-55465 [2020-19777]

Download as PDF 55464 Federal Register / Vol. 85, No. 174 / Tuesday, September 8, 2020 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Proposed Collection: Public Comment Request; Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation OMB No. 0906–0034 Ø 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 November 9, 2020. ADDRESSES: Submit your comments to paperwork@hrsa.gov. 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 SUMMARY: information request collection title for reference. Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation OMB No. 0906–0034— Revision. Abstract: The Scientific Registry of Transplant Recipients (SRTR) is administered under contract with HRSA, an agency of HHS. HHS is authorized to establish and maintain mechanisms to evaluate the long-term effects associated with living donations (42 U.S.C. 273a) and is required to submit to Congress an annual report on the long-term health effects of living donation (42 U.S.C. 273b). In 2018, the SRTR contractor implemented a pilot living donor registry in which transplant programs registered all potential living donors who provide informed consent to participate in the pilot registry. The SRTR’s authority to collect information concerning potential living organ donors is set forth in the HHS organ procurement and transplantation network regulation, 42 CFR part 121, requiring organ procurement organizations and transplant hospitals to submit to the SRTR, as appropriate, information regarding ‘‘donors of organs’’ and ‘‘other information that the Secretary deems appropriate’’ (42 CFR 121.11(b)(2)). In 2018, an updated version of the data collection instrument was approved. The data collection modifications improve the quality of the data and reduce the administrative burden for respondents. Need and Proposed Use of the Information: The transplant programs submit health information collected at the time of donation evaluation through a secure web-based data collection tool developed by the contractor. The SRTR contractor maintains contact with registry participants and collects data on long-term health outcomes through surveys. The data collection includes outcomes of evaluation, including reasons for non-donation. The living donor registry is an ongoing effort, and the goal is to continue to collect data on living organ donor transplant programs in the United States over time. Monitoring and reporting of long-term health outcomes of living organ donors post-donation will continue to provide useful information to transplant programs in their future donor selection process and aid potential living organ donors in their decision to pursue living donation. There were minor revisions to the burden per response as it has decreased from the current amount due to improvements to the efficiency of the processes used by programs for data submission, as well as the tools provided for program use by SRTR Likely Respondents: Potential living donors, transplant programs, medical and scientific organizations, and public organizations. 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 Average number of responses per respondent a 16 Potential Living Donor Registration form ............................. Potential Living Donor Follow-up form ................................ Reasons Did not Donate form (liver or kidney) ................... b 754 Total .............................................................................. Total number of responses Average burden per response (in hours) Total Burden Hours a 16 112 1 106 1,792 754 1,696 .27 .50 .23 484 377 390 786 ........................ 4,245 ........................ 1,251 jbell on DSKJLSW7X2PROD with NOTICES a Number of respondents is based on the current number of transplant programs and is likely to increase as additional programs decide to participate. b Number of living organ donor candidates submitting follow-up forms in 2019. HRSA specifically requests comments on (1) the necessity and utility of the proposed information collection for the VerDate Sep<11>2014 16:32 Sep 04, 2020 Jkt 250001 proper performance of the agency’s functions, (2) the accuracy of the estimated burden, (3) ways to enhance PO 00000 Frm 00057 Fmt 4703 Sfmt 4703 the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques E:\FR\FM\08SEN1.SGM 08SEN1 Federal Register / Vol. 85, No. 174 / Tuesday, September 8, 2020 / Notices or other forms of information technology to minimize the information collection burden. Maria G. Button, Director, Executive Secretariat. [FR Doc. 2020–19777 Filed 9–4–20; 8:45 am] BILLING CODE 4165–15–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; Information Collection Request Title: Substance Use Disorder Treatment and Recovery Loan Repayment Program, OMB No. 0906– xxxx—New 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 October 8, 2020. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under Review—Open for Public Comments’’ or by using the search function. 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: Substance Use Disorder Treatment and Recovery Loan Repayment Program OMB No. 0906–xxxx—New jbell on DSKJLSW7X2PROD with NOTICES DATES: VerDate Sep<11>2014 16:32 Sep 04, 2020 Jkt 250001 Abstract: The Further Consolidated Appropriations Act, 2020 included no less than $12,000,000 for HRSA to establish the Loan Repayment Program for Substance Use Disorder Treatment Workforce. This funding will allow HRSA to provide the repayment of education loans for individuals working in either a full-time substance use disorder treatment job that involves direct patient care in a Health Professional Shortage Area (HPSA) designated for Mental Health or a county where the average drug overdose death rate exceeds the national average. Eligible disciplines include but are not limited to behavioral health paraprofessionals, occupational therapists and counselors. Eligible treatment facilities include but are not limited to inpatient psychiatric facilities, recovery centers, detox facilities, emergency department and local community jails and detention centers. The Department of Health and Human Services agrees to repay the qualifying educational loans up to $250,000.00 in return for six years of service obligation. The forms utilized by the Substance Use Disorder Treatment and Recovery (STAR) Loan Repayment Program (LRP) include the following: the STAR LRP Application, the Authorization for Disclosure of Loan Information form, the Privacy Act Release Authorization form, the Employment Verification form, and the Site Application form, if applicable. The aforementioned forms collect information that is needed for selecting participants and repaying qualifying educational loans. Eligible facilities for the STAR LRP are facilities that provide in-patient and outpatient, ambulatory, primary and mental/behavioral health care services to populations residing in a mental health HPSA or a county where the average drug overdose death rate exceeds the national average. The facilities that may provide related inpatient services may include, but are not limited to Centers for Medicare & Medicaid Services-approved Critical Access Hospitals, American Indian Health Facilities (Indian Health Service Facilities, Tribally-Operated 638 Health Programs, and Urban Indian Health Programs), inpatient rehabilitation centers and psychiatric facilities. HRSA will recruit facilities for approval. New facilities must submit an application for review and approval. The application requests will contain supporting information on the clinical service site, recruitment contact and services provided. Assistance in completing this application may be obtained through the appropriate HRSA personnel. HRSA PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 55465 will use the information collected on the applications to determine eligibility of the facility for the assignment of health professionals and to verify the need for clinicians. Note: Despite the similarity in the titles, the STAR LRP is not the existing NHSC Substance Use Disorder LRP (OMB #0915– 0127), which is authorized under Title III of the Public Health Service Act. The STAR LRP is a newly authorized Title VII program that has different service requirements, loan repayment protocols, and authorized employment facilities. A 60-day notice published in the Federal Register on June 4, 2020, vol. 85, No. 108; pp. 34454–34456. There were no public comments. Need and Proposed Use of the Information: The need and purpose of this information collection is to obtain information that is used to assess a STAR LRP applicant’s eligibility and qualifications for the program, and to obtain information for eligible site applicants. Clinicians interested in participating in the STAR LRP must submit an application to the program in order to participate, and health care facilities located in a high overdose rate or Mental Health HPSAs must submit a Site Application to determine the eligibility of sites to participate in the STAR LRP. The STAR LRP application asks for personal, professional and financial information needed to determine the applicant’s eligibility to participate in the STAR LRP. In addition, applicants must provide information regarding the loans for which repayment is being requested. Likely Respondents: Likely respondents include: licensed primary care medical, mental and behavioral health providers, and other paraprofessionals who are employed or seeking employment, and are interested in serving underserved populations; health care facilities interested in participating in the STAR LRP, and becoming an approved service site; STAR LRP sites providing behavioral health care services directly, or through a formal affiliation with a comprehensive community-based primary behavioral health setting, facility providing comprehensive behavioral health services, or various substance abuse treatment facility subtypes. 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 E:\FR\FM\08SEN1.SGM 08SEN1

Agencies

[Federal Register Volume 85, Number 174 (Tuesday, September 8, 2020)]
[Notices]
[Pages 55464-55465]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-19777]



[[Page 55464]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Resources and Services Administration


Agency Information Collection Activities: Proposed Collection: 
Public Comment Request; Information Collection Request Title: 
Scientific Registry of Transplant Recipients Information Collection 
Effort for Potential Donors for Living Organ Donation OMB No. 0906-0034 
- 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 November 
9, 2020.

ADDRESSES: Submit your comments to [email protected].

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: Scientific Registry of 
Transplant Recipients Information Collection Effort for Potential 
Donors for Living Organ Donation OMB No. 0906-0034--Revision.
    Abstract: The Scientific Registry of Transplant Recipients (SRTR) 
is administered under contract with HRSA, an agency of HHS. HHS is 
authorized to establish and maintain mechanisms to evaluate the long-
term effects associated with living donations (42 U.S.C. 273a) and is 
required to submit to Congress an annual report on the long-term health 
effects of living donation (42 U.S.C. 273b). In 2018, the SRTR 
contractor implemented a pilot living donor registry in which 
transplant programs registered all potential living donors who provide 
informed consent to participate in the pilot registry. The SRTR's 
authority to collect information concerning potential living organ 
donors is set forth in the HHS organ procurement and transplantation 
network regulation, 42 CFR part 121, requiring organ procurement 
organizations and transplant hospitals to submit to the SRTR, as 
appropriate, information regarding ``donors of organs'' and ``other 
information that the Secretary deems appropriate'' (42 CFR 
121.11(b)(2)).
    In 2018, an updated version of the data collection instrument was 
approved. The data collection modifications improve the quality of the 
data and reduce the administrative burden for respondents.
    Need and Proposed Use of the Information: The transplant programs 
submit health information collected at the time of donation evaluation 
through a secure web-based data collection tool developed by the 
contractor. The SRTR contractor maintains contact with registry 
participants and collects data on long-term health outcomes through 
surveys. The data collection includes outcomes of evaluation, including 
reasons for non-donation. The living donor registry is an ongoing 
effort, and the goal is to continue to collect data on living organ 
donor transplant programs in the United States over time. Monitoring 
and reporting of long-term health outcomes of living organ donors post-
donation will continue to provide useful information to transplant 
programs in their future donor selection process and aid potential 
living organ donors in their decision to pursue living donation.
    There were minor revisions to the burden per response as it has 
decreased from the current amount due to improvements to the efficiency 
of the processes used by programs for data submission, as well as the 
tools provided for program use by SRTR
    Likely Respondents: Potential living donors, transplant programs, 
medical and scientific organizations, and public organizations.
    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
----------------------------------------------------------------------------------------------------------------
                                                      Average                         Average
                                     Number of       number of     Total  number    burden per     Total Burden
            Form name               respondents    responses per   of  responses   response  (in       Hours
                                                    respondent                        hours)
----------------------------------------------------------------------------------------------------------------
Potential Living Donor                    \a\ 16             112           1,792             .27             484
 Registration form..............
Potential Living Donor Follow-up         \b\ 754               1             754             .50             377
 form...........................
Reasons Did not Donate form               \a\ 16             106           1,696             .23             390
 (liver or kidney)..............
                                 -------------------------------------------------------------------------------
    Total.......................             786  ..............           4,245  ..............           1,251
----------------------------------------------------------------------------------------------------------------
\a\ Number of respondents is based on the current number of transplant programs and is likely to increase as
  additional programs decide to participate.
\b\ Number of living organ donor candidates submitting follow-up forms in 2019.

    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

[[Page 55465]]

or other forms of information technology to minimize the information 
collection burden.

Maria G. Button,
Director, Executive Secretariat.
[FR Doc. 2020-19777 Filed 9-4-20; 8:45 am]
BILLING CODE 4165-15-P