82 FR 46509 - Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Resources and Services Administration Federal Register Volume 82, Issue 192 (October 5, 2017)
Health Resources and Services Administration
Federal Register Volume 82, Issue 192 (October 5, 2017)
| Page Range | 46509-46510 | |
| FR Document | 2017-21490 |
[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)] [Notices] [Pages 46509-46510] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-21490] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration [OMB No. 0906-xxxx--New] Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation AGENCY: Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). 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 [[Page 46510]] 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 November 6, 2017. 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: When submitting comments or requesting information, please include the information request collection title for reference, in compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995. Information Collection Request Title: Scientific Registry of Transplant Recipients Information Collection Effort for Potential Donors for Living Organ Donation--OMB No. 0906-xxxx--New 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). The SRTR contractor will establish a pilot living donor registry in which 14 transplant programs will register all potential living donors who provide informed consent to participate in the pilot registry. The SRTR's authority to collect information concerning potential living donors is set forth in the Organ Procurement and Transplantation Network final rule 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). Need and Proposed Use of the Information: The transplant programs will 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 will maintain contact with registry participants and collect data on long-term health outcomes through surveys. The data collection will also include outcomes of evaluation including reasons for non-donation. The goal of the pilot registry is to develop data collection tools and survey instruments that can be used to expand the registry to include most, if not all, living donor transplant programs in the United States over time. Monitoring and reporting of long-term health outcomes of living donors post donation will provide useful information to transplant programs in their future donor selection process and will aid potential living donors in their decision to pursue living donation. 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 14 55.43 776 1 776 Registration form.............. Reasons Did not Donate Form 14 27.71 388 .50 194 (liver or kidney).............. Potential Living Donor Follow-up 776 1 776 .50 388 form........................... ------------------------------------------------------------------------------- Total....................... * 804 .............. 1,940 .............. 1,358 ---------------------------------------------------------------------------------------------------------------- * Number of respondents for potential living donor registration and reasons did not donate forms based on number of programs participating in the pilot registry. Number of respondents for potential living donor follow-up forms based on number of potential living donors evaluated at the 14 participating programs in 2015. 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. Amy McNulty, Acting Director, Division of the Executive Secretariat. [FR Doc. 2017-21490 Filed 10-4-17; 8:45 am] BILLING CODE 4165-15-P
![Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46509
Meeting.’’ Received comments will be I. Background number of participants from each
placed in the docket and, except for The ICH, formerly known as the organization may be limited based on
those submitted as ‘‘Confidential International Conference on space limitations. Registrants will
Submissions,’’ publicly viewable at Harmonisation, was established in 1990 receive confirmation once they have
http://www.regulations.gov or at the as a joint regulatory/industry project to been accepted. If you need special
Dockets Management Staff between 9 improve, through harmonization, the accommodations because of a disability,
a.m. and 4 p.m., Monday through efficiency of the process for developing please contact Amanda Roache (see FOR
Friday. and registering new medicinal products FURTHER INFORMATION CONTACT) at least 7
in Europe, Japan, and the United States days before the webinar.
• Confidential Submissions—To
submit a comment with confidential without compromising the regulatory B. Requests for Oral Presentations
information that you do not wish to be obligations of safety and effectiveness.
Interested persons may present data,
made publicly available, submit your In 2015 the ICH was reformed to make
information, or views orally or in
comments only as a written/paper the ICH a true global initiative that
writing on issues pending at the public
expands beyond the previous ICH
submission. You should submit two webinar. Public oral presentations will
members. More involvement from
copies total. One copy will include the be scheduled between approximately
regulators around the world is expected,
information you claim to be confidential 11:30 a.m. and 12 noon. Time allotted
as they will join their counterparts from
with a heading or cover note that states for oral presentations may be limited to
Europe, Japan, the United States,
‘‘THIS DOCUMENT CONTAINS 5 minutes. Those desiring to make oral
Canada, and Switzerland as ICH
CONFIDENTIAL INFORMATION.’’ The presentations should notify Amanda
regulatory members. The reforms build
Agency will review this copy, including Roache (see FOR FURTHER INFORMATION
on a 25-year track record of successful
the claimed confidential information, in CONTACT) by October 12, 2017, and
delivery of harmonized guidelines for
its consideration of comments. The submit a brief statement of the general
global pharmaceutical development,
second copy, which will have the nature of the evidence or arguments
and their regulation. In recent years,
claimed confidential information they wish to present; the names and
many important initiatives have been
redacted/blacked out, will be available addresses, telephone number, fax, and
undertaken by regulatory authorities
for public viewing and posted on email of proposed participants; and an
and industry associations to promote
https://www.regulations.gov. Submit indication of the approximate time
international harmonization of
both copies to the Dockets Management requested to make their presentation.
regulatory requirements. FDA has
Staff. If you do not wish your name and participated in many meetings designed The agenda for the public webinar will
contact information to be made publicly to enhance harmonization and is be made available on the internet at
available, you can provide this committed to seeking scientifically https://www.fda.gov/Drugs/NewsEvents/
information on the cover sheet and not based harmonized technical procedures ucm574251.htm.
in the body of your comments and you for pharmaceutical development. One of Dated: September 29, 2017.
must identify this information as the goals of harmonization is to identify Anna K. Abram,
‘‘confidential.’’ Any information marked and then reduce differences in technical Deputy Commissioner for Policy, Planning,
as ‘‘confidential’’ will not be disclosed requirements for medical product Legislation, and Analysis.
except in accordance with 21 CFR 10.20 development among regulatory [FR Doc. 2017–21437 Filed 10–4–17; 8:45 am]
and other applicable disclosure law. For Agencies. ICH was organized to provide BILLING CODE 4164–01–P
more information about FDA’s posting an opportunity for harmonization
of comments to public dockets, see 80 initiatives to be developed with input
FR 56469, October 12, 2017, or access from both regulatory and industry DEPARTMENT OF HEALTH AND
the information at: https://www.gpo.gov/ representatives. The ICH process has HUMAN SERVICES
fdsys/pkg/FR-2015-09-18/pdf/2015- achieved significant harmonization of
the technical requirements for the Health Resources and Services
23389.pdf. Administration
approval of pharmaceuticals for human
Docket: For access to the docket to use in the ICH regions over the past two [OMB No. 0906–xxxx—New]
read background documents or the decades. The current ICH process and
electronic and written/paper comments structure can be found at the following Agency Information Collection
received, go to https:// Web site: http://www.ich.org. (FDA has Activities: Submission to OMB for
www.regulations.gov and insert the verified the Web site addresses as of the Review and Approval; Public Comment
docket number, found in brackets in the date this document publishes in the Request; Information Collection
heading of this document, into the Federal Register, but Web sites are Request Title: Scientific Registry of
‘‘Search’’ box and follow the prompts subject to change over time.) Transplant Recipients Information
and/or go to the Dockets Management Collection Effort for Potential Donors
Staff, 5630 Fishers Lane, Rm. 1061, II. Webinar Attendance and
for Living Organ Donation
Rockville, MD 20852. Participation
A. Registration AGENCY: Health Resources and Services
FOR FURTHER INFORMATION CONTACT: Administration (HRSA), Department of
Amanda Roache, Food and Drug If you wish to attend the meeting, Health and Human Services (HHS).
Administration, Center for Drug please register at the following Web site: ACTION: Notice.
Evaluation and Research, Office of https://healthcanada-usfda_ich_
ethrower on DSK3G9T082PROD with NOTICES
Strategic Programs, 10903 New consultation.eventbrite.ca. For those SUMMARY: In compliance with the
Hampshire Ave., Bldg. 51, Rm. 1176, attending online, a link will be provided Paperwork Reduction Act of 1995,
Silver Spring MD, 20993, 301–796– upon registration. In person HRSA has submitted an Information
4548, email: Amanda.Roache@ registrations may be limited, so early Collection Request (ICR) to the Office of
fda.hhs.gov. registration is recommended. Management and Budget (OMB) for
Registration is free and will be on a first- review and approval. Comments
SUPPLEMENTARY INFORMATION: come, first-served basis. However, the submitted during the first public review
VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\05OCN1.SGM 05OCN1](https://thefederalregister.org/doc/82_FR_46701/page/1.svg)
![46510 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices
of this ICR will be provided to OMB. mechanisms to evaluate the long-term collection tools and survey instruments
OMB will accept further comments from effects associated with living donations that can be used to expand the registry
the public during the review and (42 U.S.C. 273a) and is required to to include most, if not all, living donor
approval period. submit to Congress an annual report on transplant programs in the United States
DATES: Comments on this ICR should be the long-term health effects of living over time. Monitoring and reporting of
received no later than November 6, donation (42 U.S.C. 273b). The SRTR long-term health outcomes of living
2017. contractor will establish a pilot living donors post donation will provide
ADDRESSES: Submit your comments, donor registry in which 14 transplant useful information to transplant
including the ICR Title, to the desk programs will register all potential programs in their future donor selection
officer for HRSA, either by email to living donors who provide informed process and will aid potential living
OIRA_submission@omb.eop.gov or by consent to participate in the pilot donors in their decision to pursue living
fax to 202–395–5806. registry. The SRTR’s authority to collect donation.
FOR FURTHER INFORMATION CONTACT: To
information concerning potential living Likely Respondents: Potential living
request a copy of the clearance requests donors is set forth in the Organ donors, transplant programs, medical
submitted to OMB for review, email Lisa Procurement and Transplantation and scientific organizations, and public
Wright-Solomon, the HRSA Information Network final rule requiring Organ organizations.
Collection Clearance Officer at Procurement Organizations and Burden Statement: Burden in this
paperwork@hrsa.gov or call (301) 443– transplant hospitals to submit to the context means the time expended by
1984. SRTR, as appropriate, information persons to generate, maintain, retain,
regarding ‘‘donors of organs’’ and ‘‘other disclose or provide the information
SUPPLEMENTARY INFORMATION: When
information that the Secretary deems requested. This includes the time
submitting comments or requesting
appropriate.’’ 42 CFR 121.11(b)(2). needed to review instructions; to
information, please include the
information request collection title for Need and Proposed Use of the develop, acquire, install, and utilize
reference, in compliance with Section Information: The transplant programs technology and systems for the purpose
3506(c)(2)(A) of the Paperwork will submit health information collected of collecting, validating, and verifying
Reduction Act of 1995. at the time of donation evaluation information, processing and
Information Collection Request Title: through a secure web-based data maintaining information, and disclosing
Scientific Registry of Transplant collection tool developed by the and providing information; to train
Recipients Information Collection Effort contractor. The SRTR contractor will personnel and to be able to respond to
for Potential Donors for Living Organ maintain contact with registry a collection of information; to search
Donation—OMB No. 0906–xxxx—New participants and collect data on long- data sources; to complete and review
Abstract: The Scientific Registry of term health outcomes through surveys. the collection of information; and to
Transplant Recipients (SRTR) is The data collection will also include transmit or otherwise disclose the
administered under contract with outcomes of evaluation including information. The total annual burden
HRSA, an agency of HHS. HHS is reasons for non-donation. The goal of hours estimated for this ICR are
authorized to establish and maintain the pilot registry is to develop data 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 hours
respondent (in hours)
Potential Living Donor Registration form ............................. 14 55.43 776 1 776
Reasons Did not Donate Form (liver or kidney) .................. 14 27.71 388 .50 194
Potential Living Donor Follow-up form ................................ 776 1 776 .50 388
Total .............................................................................. * 804 ........................ 1,940 ........................ 1,358
* Number of respondents for potential living donor registration and reasons did not donate forms based on number of programs participating in
the pilot registry. Number of respondents for potential living donor follow-up forms based on number of potential living donors evaluated at the 14
participating programs in 2015.
HRSA specifically requests comments the quality, utility, and clarity of the technology to minimize the information
on (1) the necessity and utility of the information to be collected; and (4) the collection burden.
proposed information collection for the use of automated collection techniques Amy McNulty,
proper performance of the agency’s or other forms of information
functions; (2) the accuracy of the Acting Director, Division of the Executive
Secretariat.
estimated burden; (3) ways to enhance
[FR Doc. 2017–21490 Filed 10–4–17; 8:45 am]
BILLING CODE 4165–15–P
ethrower on DSK3G9T082PROD with NOTICES
VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 PO 00000 Frm 00035 Fmt 4703 Sfmt 9990 E:\FR\FM\05OCN1.SGM 05OCN1](https://thefederalregister.org/doc/82_FR_46701/page/2.svg)
Document Created: 2017-10-05 00:53:21
Document Modified: 2017-10-05 00:53:21
| 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 November 6, 2017. | |
| 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 | 82 FR 46509 |
2025 Federal Register | Disclaimer | Privacy Policy
USC | CFR | eCFR