Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 46509 

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/2015- 

23389.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. 

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: 

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 

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 

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 


ethrower on DSK3G9T082PROD with NOTICES
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

Form name Number of 

respondents 

Average 

number of 

responses per 

respondent 

Total number 

of responses 

Average 

burden per 

response 

(in hours) 

Total burden 

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 

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 


ethrower on DSK3G9T082PROD with NOTICES