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, 46509-46510 [2017-21490]

Download as PDF Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices Meeting.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://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, October 12, 2017, or access the information at: https://www.gpo.gov/ 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. ethrower on DSK3G9T082PROD with NOTICES FOR FURTHER INFORMATION CONTACT: Amanda Roache, Food and Drug Administration, Center for Drug Evaluation and Research, Office of Strategic Programs, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring MD, 20993, 301–796– 4548, email: Amanda.Roache@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 19:52 Oct 04, 2017 Jkt 244001 I. Background The ICH, formerly known as the International Conference on Harmonisation, was established in 1990 as a joint regulatory/industry project to improve, through harmonization, the efficiency of the process for developing and registering new medicinal products in Europe, Japan, and the United States without compromising the regulatory obligations of safety and effectiveness. In 2015 the ICH was reformed to make the ICH a true global initiative that expands beyond the previous ICH members. More involvement from regulators around the world is expected, as they will join their counterparts from Europe, Japan, the United States, Canada, and Switzerland as ICH regulatory members. The reforms build on a 25-year track record of successful delivery of harmonized guidelines for global pharmaceutical development, and their regulation. In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in many meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in technical requirements for medical product development among regulatory Agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. The ICH process has achieved significant harmonization of the technical requirements for the approval of pharmaceuticals for human use in the ICH regions over the past two decades. The current ICH process and structure can be found at the following Web site: http://www.ich.org. (FDA has verified the Web site addresses as of the date this document publishes in the Federal Register, but Web sites are subject to change over time.) II. Webinar Attendance and Participation A. Registration If you wish to attend the meeting, please register at the following Web site: https://healthcanada-usfda_ich_ consultation.eventbrite.ca. For those attending online, a link will be provided upon registration. In person registrations may be limited, so early registration is recommended. Registration is free and will be on a firstcome, first-served basis. However, the PO 00000 Frm 00034 Fmt 4703 Sfmt 4703 46509 number of participants from each organization may be limited based on space limitations. Registrants will receive confirmation once they have been accepted. If you need special accommodations because of a disability, please contact Amanda Roache (see FOR FURTHER INFORMATION CONTACT) at least 7 days before the webinar. B. Requests for Oral Presentations Interested persons may present data, information, or views orally or in writing on issues pending at the public webinar. Public oral presentations will be scheduled between approximately 11:30 a.m. and 12 noon. Time allotted for oral presentations may be limited to 5 minutes. Those desiring to make oral presentations should notify Amanda Roache (see FOR FURTHER INFORMATION CONTACT) by October 12, 2017, and submit a brief statement of the general nature of the evidence or arguments they wish to present; the names and addresses, telephone number, fax, and email of proposed participants; and an indication of the approximate time requested to make their presentation. The agenda for the public webinar will be made available on the internet at https://www.fda.gov/Drugs/NewsEvents/ ucm574251.htm. Dated: September 29, 2017. Anna K. Abram, Deputy Commissioner for Policy, Planning, Legislation, and Analysis. [FR Doc. 2017–21437 Filed 10–4–17; 8:45 am] BILLING CODE 4164–01–P 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 Health Resources and Services Administration (HRSA), Department of Health and Human Services (HHS). 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 SUMMARY: E:\FR\FM\05OCN1.SGM 05OCN1 46510 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 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 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: 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 longterm 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 Number of respondents Form name Average number of responses per respondent Total number of responses Average burden per response (in hours) Total burden hours Potential Living Donor Registration form ............................. Reasons Did not Donate Form (liver or kidney) .................. Potential Living Donor Follow-up form ................................ 14 14 776 55.43 27.71 1 776 388 776 1 .50 .50 776 194 388 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 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] ethrower on DSK3G9T082PROD with NOTICES BILLING CODE 4165–15–P 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

Agencies

[Federal Register Volume 82, Number 192 (Thursday, October 5, 2017)]
[Notices]
[Pages 46509-46510]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-21490]


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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 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: 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