46508 Federal Register / Vol. 82, No. 192 / Thursday, October 5, 2017 / Notices 

Ravo (see FOR FURTHER INFORMATION

CONTACT) no later than October 26, 2017. 

Requests for Oral Presentations: When 

registering, you may indicate if you 

wish to present during a public 

comment session or participate in a 

specific session, and which topic(s) you 

wish to address. We will do our best to 

accommodate requests to make public 

comments. Individuals and 

organizations with common interests are 

urged to consolidate or coordinate their 

presentations, and request time for a 

joint presentation, or submit requests for 

designated representatives to participate 

in the focused sessions. Following the 

close of registration, we will determine 

the amount of time allotted to each 

presenter and the approximate time 

each oral presentation is to begin, and 

will select and notify participants by 

October 27, 2017. All requests to make 

oral presentations must be received by 

the close of registration on October 26, 

2017. If selected for presentation, any 

presentation materials must be emailed 

to Cassie Ravo (see FOR FURTHER

INFORMATION CONTACT) no later than 

October 31, 2017. No commercial or 

promotional material will be permitted 

to be presented or distributed at the 

public meeting. 

Streaming Webcast of the Public 

Meeting: This public meeting will also 

be webcast. 

Event: AGDUFA III Public Meeting. 

Event address for attendees: https://

fda.webex.com/fda/onstage/ 

g.php?MTID=ec1c356734bcf010b59

e0b885726ccad0. Date and time: 

Thursday, November 2, 2017, 1 p.m. 

Eastern Daylight Time (New York, 

GMT–4). Duration: 3 hours. Event 

number: 817 527 611. Event password: 

110217. Teleconference: Provide your 

number when you join the event to 

receive a call back. (1) Call one of the 

following numbers: Local: 1–301–796– 

7777; toll free: 1–855–828–1770. (2) 

Follow the instructions that you hear on 

the phone. Cisco Unified MeetingPlace 

meeting ID: 817 527 611. 

FDA has verified the Web site 

addresses in this document, as of the 

date this document publishes in the 

Federal Register, but Web sites are 

subject to change over time. 

Transcripts: Please be advised that as 

soon as a transcript of the public 

meeting is available, it will be accessible 

at https://www.regulations.gov. It may 

be viewed at the Dockets Management 

Staff (see ADDRESSES). A link to the 

transcript will also be available on the 

internet at https://www.fda.gov/ 

ForIndustry/UserFees/AnimalGeneric

DrugUserFeeActAGDUFA/ 

ucm270232.htm. 

Dated: September 29, 2017. 

Anna K. Abram, 

Deputy Commissioner for Policy, Planning, 

Legislation, and Analysis. 

[FR Doc. 2017–21438 Filed 10–4–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2017–N–5017] 

Health Canada and United States Food 

and Drug Administration Joint Public 

Consultation on International Council 

for Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use; Public Meeting and 

Webcast 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting and 

webcast; request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing a regional public meeting 

entitled ‘‘Health Canada and U.S. Food 

and Drug Administration Joint Public 

Consultation on International Council 

for Harmonisation of Technical 

Requirements for Pharmaceuticals for 

Human Use (ICH).’’ The purpose of this 

public meeting is to provide information 

and solicit public input on the current 

activities of ICH as well as the 

upcoming ICH Assembly Meeting and 

the Expert Working Group Meetings in 

Geneva, Switzerland, scheduled for 

November 11 through 16, 2017. The 

topics to be discussed are the topics for 

discussion at the forthcoming ICH 

Assembly Meeting in Geneva. 

DATES: The public meeting will be held 

on October 19, 2017, from 9 a.m. to 12 

noon Eastern Time. Submit either 

electronic or written comments on this 

public meeting by October 26, 2017. See 

the SUPPLEMENTARY INFORMATION section 

for registration date and information. 

Registration to attend the meeting and 

requests for oral presentations must be 

received by October 16, 2017; see the 

SUPPLEMENTARY INFORMATION section for 

information on how to register for the 

meeting. 

ADDRESSES: The public meeting will be 

held at the Sir Frederick G. Banting 

Research Centre, 251 Sir Frederick 

Banting Dr., Ottawa, ON K1Y 0M1, 

Canada. It will also be broadcast on the 

web allowing participants to join in 

person OR via the Web. 

You may submit comments as 

follows: Please note that late, untimely 

filed comments will not be considered. 

Electronic comments must be submitted 

on or before October 26, 2017. The 

https://www.regulations.gov electronic 

filing system will accept comments 

until midnight Eastern Time at the end 

of October 27, 2017. Comments received 

by mail/hand delivery/courier (for 

written/paper submissions) will be 

considered timely if they are 

postmarked or the delivery service 

acceptance receipt is on or before that 

date. 

Electronic Submissions 

Submit electronic comments in the 

following way: 

• Federal eRulemaking Portal: 

https://www.regulations.gov. Follow the 

instructions for submitting comments. 

Comments submitted electronically, 

including attachments, to https://

www.regulations.gov will be posted to 

the docket unchanged. Because your 

comment will be made public, you are 

solely responsible for ensuring that your 

comment does not include any 

confidential information that you or a 

third party may not wish to be posted, 

such as medical information, your or 

anyone else’s Social Security number, or 

confidential business information, such 

as a manufacturing process. Please note 

that if you include your name, contact 

information, or other information that 

identifies you in the body of your 

comments, that information will be 

posted on https://www.regulations.gov. 

• If you want to submit a comment 

with confidential information that you 

do not wish to be made available to the 

public, submit the comment as a 

written/paper submission and in the 

manner detailed (see ‘‘Written/Paper 

Submissions’’ and ‘‘Instructions’’). 

Written/Paper Submissions 

Submit written/paper submissions as 

follows: 

• Mail/Hand delivery/Courier (for 

written/paper submissions): Dockets 

Management Staff (HFA–305), Food and 

Drug Administration, 5630 Fishers 

Lane, Rm. 1061, Rockville, MD 20852. 

• For written/paper comments 

submitted to the Dockets Management 

Staff, FDA will post your comment, as 

well as any attachments, except for 

information submitted, marked and 

identified, as confidential, if submitted 

as detailed in ‘‘Instructions.’’ 

Instructions: All submissions received 

must include the Docket No. FDA– 

2017–N–5017 for ‘‘Health Canada and 

U.S. Food and Drug Administration 

Joint Public Consultation on 

International Council on Harmonisation 

of Technical Requirements for 

Pharmaceuticals for Human Use; Public 


ethrower on DSK3G9T082PROD with NOTICES
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