41420 Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 

of sufficient relevance and reliability to 

address the specific regulatory decision 

being considered. 

This guidance does not affect any 

Federal, State or local laws or 

regulations or foreign laws or 

regulations that may otherwise be 

applicable to the use or collection of 

RWE and that provide protections for 

human subjects or patient privacy. This 

guidance should be used to 

complement, but not supersede, other 

device-specific and good clinical 

practice guidance documents. FDA 

considered comments received on the 

draft guidance that published in the 

Federal Register of July 27, 2016 (81 FR 

49228). FDA revised the guidance as 

appropriate in response to the 

comments. 

II. Significance of Guidance 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the current 

thinking of FDA on use of real-world 

evidence to support regulatory decisionmaking for medical devices. It does not 

establish any rights for any person and 

is not binding on FDA or the public. 

You can use an alternative approach if 

it satisfies the requirements of the 

applicable statutes and regulations. This 

guidance is not subject to Executive 

Order 12866. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the guidance may do so by 

downloading an electronic copy from 

the internet. A search capability for all 

Center for Devices and Radiological 

Health guidance documents is available 

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

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

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

Vaccines/GuidanceCompliance

RegulatoryInformation/default.htm or 

https://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Use of Real-World Evidence to 

Support Regulatory Decision-Making for 

Medical Devices’’ may send an email 

request to CDRH-Guidance@fda.hhs.gov 

to receive an electronic copy of the 

document. Please use the document 

number 1500012 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This guidance refers to previously 

approved collections of information 

found in FDA regulations and guidance. 

These collections of information are 

subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501–3520). The collections 

of information in 21 CFR part 807, 

subpart E, have been approved under 

OMB control number 0910–0120; the 

collections of information in 21 CFR 

part 814, subparts A through E 

(premarket approval), have been 

approved under OMB control number 

0910–0231; the collections of 

information in 21 CFR part 814, subpart 

H (humanitarian device exemption), 

have been approved under OMB control 

number 0910–0332; the collections of 

information in 21 CFR part 812 

(investigational device exemption) have 

been approved under OMB control 

number 0910–0078; the collections of 

information in 21 CFR part 822 

(postmarket surveillance) have been 

approved under OMB control number 

0910–0449; the collections of 

information in 21 CFR 50.23 (exception 

from general requirements for informed 

consent) have been approved under 

OMB control number 0910–0586; the 

collections of information in 21 CFR 

part 54 (financial disclosure by clinical 

investigators) have been approved under 

OMB control number 0910–0396; the 

collections of information in 21 CFR 

56.115 (institutional review boards 

records) have been approved under 

OMB control number 0910–0130; and 

the collections of information in 21 CFR 

parts 50 subpart B (informed consent of 

human subjects) and 56 (institutional 

review boards) have been approved 

under OMB control number 0910–0755. 

The collections of information in the 

guidance ‘‘Requests for Feedback on 

Medical Device Submissions: The PreSubmission Program and Meetings with 

Food and Drug Administration Staff’’ 

have been approved under OMB control 

number 0910–0756. 

Dated: August 25, 2017. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2017–18469 Filed 8–30–17; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Peer Review of Draft NTP Approach to 

Genomic Dose-Response Modeling; 

Availability of Documents; Request for 

Comments; Notice of Expert Panel 

Meeting 

SUMMARY: The National Toxicology 

Program (NTP) announces an expert 

panel meeting and is obtaining 

comment on a proposed approach to 

genomic dose-response modeling. Prior 

to the expert panel meeting, NTP will 

host four webinars that present other 

approaches to genomic dose-response 

modeling. The expert panel meeting and 

four webinar presentations leading up to 

the meeting are open to the public. 

Registration is requested for both inperson meeting attendance and oral 

comment; registration is required to 

access the meeting webcast. URLs for 

live and archived pre-meeting webinars 

will be available at https://

ntp.niehs.nih.gov/about/org/ 

ntpexpertpanel/. 

DATES: 

Pre-Meeting Webinars: Dates are 

posted on the meeting Web site (https:// 

ntp.niehs.nih.gov/about/org/ 

ntpexpertpanel/). Registration is not 

required to view the pre-meeting 

webinars. 

Meeting: October 23–25, 2017; expert 

panel meeting begins at 8:30 a.m. 

Eastern Daylight Time (EDT) each day 

and continues until adjournment. 

Document Availability: Draft 

document should be available by 

August 23, 2017, at https://

ntp.niehs.nih.gov/about/org/ 

ntpexpertpanel/. 

Written Public Comment 

Submissions: Deadline is October 13, 

2017. 

Registration for Oral Comments: 

Deadline is October 13, 2017. 

Registration for Meeting and/or to 

View Webcast: Deadline is October 25, 

2017. Registration to view the meeting 

via webcast is required. 

ADDRESSES: 

Meeting Location: Rodbell 

Auditorium, Rall Building, NIEHS, 111 

T.W. Alexander Drive, Research 

Triangle Park, NC 27709. 

Meeting Web site: The draft 

document, preliminary agenda, 

registration, pre-meeting webinars 

details, and other meeting materials will 

be available at https://ntp.niehs.nih.gov/ 

about/org/ntpexpertpanel/. 

Webcast: The URL for viewing the 

expert panel meeting webcast will be 

provided to those who register. 

FOR FURTHER INFORMATION CONTACT: 

Anna Stamatogiannakis, ICF, 2635 

Meridian Parkway, Suite 200, Durham, 

NC, USA 27713. Phone: (919) 293–1652, 

Fax: (919) 293–1645, Email: 

anna.stamatogiannakis@icf.com. 

SUPPLEMENTARY INFORMATION: 

Background: NTP proposes to use the 

approach embodied in the BMDExpress 

software to perform gene and pathwaylevel genomic dose-response modeling 

as part of Tox21 Phase 3 and in vivo 

screening level studies. NTP seeks 

external scientific input on its proposed 

approach by an expert panel. NTP’s goal 


sradovich on DSK3GMQ082PROD with NOTICES
Federal Register / Vol. 82, No. 168 / Thursday, August 31, 2017 / Notices 41421 

for implementing this approach 

considers a number of factors including 

methods accepted in the peer-review 

literature, ease of translation to risk 

assessment, and ease of understanding 

for the variety of potential end users 

that may not necessarily be experts in 

mathematical and systems modeling. A 

series of four pre-meeting webinars and 

the expert panel meeting aim to review 

current approaches and discuss best 

practices. The webinar series will 

provide an overview of various current 

approaches and NTP’s proposed 

approach to genomic dose-response 

modeling. The expert panel will 

consider information presented in the 

webinars as well as other technical 

factors during its peer review of NTP’s 

proposed approach. 

Pre-Meeting Webinars Registration: 

There is no registration required to 

attend the webinars. The URLs for live 

and archived webinars will be available 

on the meeting Web site at https://

ntp.niehs.nih.gov/about/org/ 

ntpexpertpanel/; please refer to this 

page for the most current information 

about the webinars and the meeting. 

Expert Panel Meeting and 

Registration: The meeting is open to the 

public with time set aside for oral 

public comment. Interested individuals 

can attend the meeting in person or 

view the webcast. Attendance at NIEHS 

is limited only by the space available. 

For planning purposes, registration to 

attend the meeting at NIEHS or view the 

webcast is requested. Registration to 

attend the meeting in person and/or 

view the webcast is by October 25, 2017, 

at https://ntp.niehs.nih.gov/about/org/ 

ntpexpertpanel/. 

Attending the Meeting: Visitor and 

security information for those attending 

in person is available at https://

www.niehs.nih.gov/about/visiting/ 

index.cfm. Individuals with disabilities 

who need accommodation to participate 

in this event should contact Anna 

Stamatogiannakis by phone: (919) 293– 

1652 or email: anna.stamatogiannakis@

icf.com. TTY users should contact the 

Federal TTY Relay Service at (800) 877– 

8339. Requests should be made at least 

five business days in advance of the 

event. 

Meeting Materials: The expert panel 

meeting agenda will be available on the 

meeting Web site at https://

ntp.niehs.nih.gov/about/org/ 

ntpexpertpanel/. The draft document 

should be available by August 23, 2017. 

Additional information will be posted 

when available or may be requested in 

hardcopy, see FOR FURTHER INFORMATION

CONTACT. 

Following the meeting, a report of the 

panel meeting will be prepared and 

made available on the NTP Web site. 

Individuals are encouraged to access the 

meeting Web site to stay abreast of the 

most current information regarding the 

meeting. 

Request for Comments: NTP invites 

written and oral public comments on 

the draft NTP approach. The deadline 

for submission of written comments is 

October 13, 2017, to enable review by 

the peer review panel and NTP staff 

prior to the meeting. Written public 

comments and any other 

correspondence on NTP’s proposed 

approach should be sent to the FOR

FURTHER INFORMATION CONTACT. Persons 

submitting written comments should 

include their name, affiliation, mailing 

address, phone, email, and sponsoring 

organization (if any). Written comments 

received in response to this notice will 

be posted on the NTP Web site and the 

submitter identified by name, affiliation, 

and/or sponsoring organization (if any). 

Guidelines for public comments are at 

https://ntp.niehs.nih.gov/ntp/about_

ntp/guidelines_public_comments_

508.pdf. 

Oral public comment at this meeting 

is welcome, with time set aside on 

October 23 for the formal presentation 

of oral remarks on the draft document. 

In addition to in-person oral comments 

at the NIEHS, public comments can be 

presented by teleconference line. There 

will be 50 lines for this call; availability 

is on a first-come, first-served basis. The 

lines will be open from 8:30 a.m. each 

day until adjournment. Oral comments 

will be received only during the formal 

public comment periods indicated on 

the preliminary agenda. The access 

number for the teleconference line will 

be provided to registrants by email prior 

to the meeting. Each organization is 

allowed one time slot. At least 7 

minutes will be allotted to each time 

slot, and if time permits, the allotment 

may be extended to 10 minutes at the 

discretion of the chair. In addition to the 

formal public comment period, there 

will be several opportunities in the 

agenda for ad hoc comments. 

Persons wishing to make oral 

comments during the formal comment 

period on October 23 are asked to 

register online at https://

ntp.niehs.nih.gov/about/org/ 

ntpexpertpanel/ by October 13, 2017, 

and indicate whether they will present 

comments in person or via the 

teleconference line. Oral public 

commenters are asked to send a copy of 

their slides and/or statement or talking 

points to the FOR FURTHER INFORMATION

CONTACT by October 13, 2017. Written 

statements can supplement and may 

expand the oral presentation. 

Registration for in-person oral 

comments will also be available at the 

meeting, although time allowed for 

presentation by on-site registrants may 

be less than that for registered speakers 

and will be determined by the number 

of speakers who register on-site. Time is 

also being set aside in the agenda for ad 

hoc comments by both in-person 

attendees and webcast viewers. 

Information on how to make oral 

remarks during those ad hoc comment 

periods will be provided at the meeting. 

Background Information on Expert 

Panels: NTP panels are technical, 

scientific advisory bodies established on 

an ‘‘as needed’’ basis to provide 

independent scientific peer review and 

advise NTP on agents of public health 

concern, new/revised toxicological test 

methods, or other issues. These panels 

help ensure transparent, unbiased, and 

scientifically rigorous input to the 

program for its use in making credible 

decisions about human hazard, setting 

research and testing priorities, and 

providing information to regulatory 

agencies about alternative methods. 

NTP welcomes public comment for 

dose-response modeling. 

Dated: August 15, 2017. 

John R. Bucher, 

Associate Director, National Toxicology 

Program. 

[FR Doc. 2017–18462 Filed 8–30–17; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF THE INTERIOR 

Fish and Wildlife Service 

[FWS–HQ–R–2017–N102; 

FXRS12630900000–167–FF09R81000; OMB 

Control Number 1018–0140] 

Agency Information Collection 

Activities; Hunting and Fishing 

Application Forms and Activity 

Reports for National Wildlife Refuges 

AGENCY: Fish and Wildlife Service, 

Interior. 

ACTION: Notice of Information 

Collection; request for comment. 

SUMMARY: In accordance with the 

Paperwork Reduction Act of 1995, we, 

the U.S. Fish and Wildlife Service 

(Service) are proposing to revise an 

information collection. 

DATES: Interested persons are invited to 

submit comments on or before October 

30, 2017. 

ADDRESSES: Send your comments on the 

information collection request (ICR) by 

mail to the Service Information 

Collection Clearance Officer, U.S. Fish 

and Wildlife Service, MS: BPHC, 5275 

Leesburg Pike, Falls Church, VA 22041– 


sradovich on DSK3GMQ082PROD with NOTICES