Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 22205 

meeting will be based on space 

availability. 

If you wish to present at the meeting, 

please include your presentation 

materials along with your registration 

information to GenericDrugPolicy@

fda.hhs.gov by June 1, 2015. Early 

requests for oral presentations are 

recommended due to possible space and 

time limitations. FDA will 

accommodate as many requests for oral 

presentations as possible and will do so 

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

time allotted for presentations may 

depend on the number of persons who 

wish to speak. Those requesting to 

present will receive confirmation once 

they have been accepted. If 

presentations exceed time and space 

limitations prior to the meeting, FDA 

will place a notice on http://

www.fda.gov/gdufa. Onsite requests for 

oral presentations on the day of the 

meeting will be based on time and space 

availability. If the entire meeting time is 

not needed, FDA may end the public 

meeting early. 

If you need special accommodations 

because of a disability, please contact 

Connie Wisner or Kimberly Giordano 

(see FOR FURTHER INFORMATION CONTACT) 

by June 8, 2015. 

For those unable to attend in person, 

FDA will provide a live Adobe Connect 

Webcast of the meeting. In order to 

connect to the Webcast, you must have 

Adobe Connect. To join the meeting via 

the Adobe Connect Webcast, please go 

to: https://collaboration.fda.gov/gdufaii. 

IV. Comments 

Regardless of participation at the 

public meeting, interested persons may 

submit either electronic or written 

comments regarding this document. To 

ensure consideration, all comments 

should be received by July 15, 2015. 

Submission of comments prior to the 

meeting is strongly encouraged. 

Submit electronic comments to 

http://www.regulations.gov. Submit 

written comments to the Division of 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Identify all comments with the docket 

number found in the brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday. 

V. Transcripts 

Please be advised that as soon as a 

transcript is available, it will be 

accessible at http://www.regulations.gov 

and http://www.fda.gov/gdufa. It may be 

viewed at the Division of Dockets 

Management (see section IV). A 

transcript also will be available in either 

hard copy or on CD–ROM upon 

submission of a Freedom of Information 

request. Send written requests to the 

Division of Freedom of Information 

(ELEM–1029), Food and Drug 

Administration, 12420 Parklawn Dr., 

Element Bldg., Rockville, MD 20857. 

Dated: April 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09091 Filed 4–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2015–D–0975] 

Acceptance of Medical Device Clinical 

Data From Studies Conducted Outside 

the United States; Draft Guidance for 

Industry and Food and Drug 

Administration Staff; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA or Agency) is 

announcing the availability of the draft 

guidance entitled ‘‘Acceptance of 

Medical Device Clinical Data from 

Studies Conducted Outside the United 

States; Draft Guidance for Industry and 

Food and Drug Administration Staff.’’ 

This draft guidance articulates FDA’s 

current policy of accepting scientifically 

valid clinical data obtained from foreign 

clinical studies in support of premarket 

submissions for devices. The guidance 

describes special considerations that 

apply when using such data, including 

applicability to populations within the 

United States and study design issues 

and provides recommendations to assist 

sponsors in ensuring their data are 

adequate under applicable FDA 

standards to support approval or 

clearance of the device in the United 

States. This guidance is not intended to 

announce new policy, but to describe 

FDA’s existing approach to this topic. 

This draft guidance is not final nor is it 

in effect at this time. 

DATES: Although you can comment on 

any guidance at any time (see 21 CFR 

10.115(g)(5)), to ensure that the Agency 

considers your comment on this draft 

guidance before it begins work on the 

final version of the guidance, submit 

either electronic or written comments 

on the draft guidance by July 20, 2015. 

ADDRESSES: An electronic copy of the 

guidance document is available for 

download from the Internet. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. Submit written requests for a 

single hard copy of the draft guidance 

document entitled ‘‘Acceptance of 

Medical Device Clinical Data from 

Studies Conducted Outside the United 

States; Draft Guidance for Industry and 

Food and Drug Administration Staff’’ to 

the Office of the Center Director, 

Guidance and Policy Development, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

Rm. 5431, Silver Spring, MD 20993– 

0002 or the Office of Communication, 

Outreach and Development, Center for 

Biologics Evaluation and Research 

(CBER), Food and Drug Administration, 

10903 New Hampshire Avenue, Bldg. 

71, Rm. 3128, Silver Spring, MD 20993. 

Send one self-addressed adhesive label 

to assist that office in processing your 

request. 

Submit electronic comments on the 

draft guidance to http://

www.regulations.gov. Submit written 

comments to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, Rm. 

1061, Rockville, MD 20852. Identify 

comments with the docket number 

found in brackets in the heading of this 

document. 

FOR FURTHER INFORMATION CONTACT: 

Aaliyah Eaves-Lean ̃ os, Center for 

Devices and Radiological Health, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 66, Rm. 5420, 

Silver Spring, MD 20993–0002, 301– 

796–2948. For questions regarding this 

document concerning devices regulated 

by CBER, contact Stephen Ripley, 10903 

New Hampshire Ave., Bldg. 71, Rm. 

7301, Silver Spring, MD 20993–0002, 

240–402–7911. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, the President signed 

into law the Food and Drug 

Administration Safety and Innovation 

Act (FDASIA), Public Law 112–144 

(2012), adding a new provision, section 

569B, to the Federal Food, Drug, and 

Cosmetic Act (FD&C Act) codifying 

FDA’s longstanding policy of accepting 

adequate, ethically-derived, 

scientifically valid data without regard 

to where a clinical study is conducted. 

Sponsors may choose to conduct 

multinational clinical studies under a 

variety of scenarios. FDA acknowledges, 

however, that certain challenges exist in 

using data derived from studies of 

devices from sites from outside the 

United States (OUS) to support an FDA 


tkelley on DSK3SPTVN1PROD with NOTICES
22206 Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 

marketing decision. These challenges 

may include differences between the 

OUS and U.S. clinical conditions, 

regulatory requirements (including 

human subject protections), and/or 

study populations that may be sufficient 

to affect the adequacy of the data for use 

in establishing the safety and/or 

effectiveness of the studied device. This 

guidance focuses on considerations 

sponsors of device submissions should 

take into account when initiating, or 

relying on previously collected data 

from, an OUS clinical study to support 

an Investigational Device Exemption, 

Premarket Notification (510(k)), De 

Novo Petition, Humanitarian Device 

Exemption, or Premarket Approval 

Application. This guidance also notes 

other important considerations to take 

into account when initiating or relying 

on OUS data. FDA believes that 

promoting greater clarity concerning 

FDA’s use of foreign study data will 

minimize the possibility for additional 

or duplicative U.S. studies, further 

efforts to harmonize global clinical trial 

standards, and promote public health 

and innovation. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the Agency’s current thinking 

on acceptance of clinical data from 

foreign studies conducted OUS. It does 

not create or confer any rights for or on 

any person and does not operate to bind 

FDA or the public. An alternative 

approach may be used if such approach 

satisfies the requirements of the 

applicable statute and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by 

downloading an electronic copy from 

the Internet. A search capability for all 

Centers for Devices and Radiological 

Health guidance documents is available 

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

DeviceRegulationandGuidance/

GuidanceDocuments/default.htm. 

Guidance documents are also available 

at http://www.regulations.gov. Persons 

unable to download an electronic copy 

of ‘‘Acceptance of Medical Device 

Clinical Data from Studies Conducted 

Outside the United States; Draft 

Guidance for Industry and Food and 

Drug Administration Staff’’ may send an 

email request to CDRH-Guidance@

fda.hhs.gov to receive an electronic 

copy of the document. Please use the 

document number 1741 to identify the 

guidance you are requesting. 

IV. Paperwork Reduction Act of 1995 

This draft guidance refers to currently 

approved collections of information 

found in FDA regulations. 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 parts 50 and 56 have been 

approved under OMB control number 

0910–0755; the collections of 

information in 21 CFR part 601 have 

been approved under OMB control 

number 0910–0338; the collections of 

information in 21 CFR parts 801 and 

809 have been approved under OMB 

control number 0910–0485; 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 812 has been approved under OMB 

control number 0910–0078; the 

collections of information in 21 CFR 

part 814 have been approved under 

OMB control number 0910–0231; the 

collections of information in 21 CFR 

part 814, subpart H have been approved 

under OMB control number 0910–0332; 

and the collections of information in 21 

CFR part 820 have been approved under 

OMB control number 0910–0073. 

V. Comments 

Interested persons may submit either 

electronic comments regarding this 

document to http://www.regulations.gov 

or written comments to the Division of 

Dockets Management (see ADDRESSES). It 

is only necessary to send one set of 

comments. Identify comments with the 

docket number found in brackets in the 

heading of this document. Received 

comments may be seen in the Division 

of Dockets Management between 9 a.m. 

and 4 p.m., Monday through Friday, and 

will be posted to the docket at http://

www.regulations.gov. 

Dated: April 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09176 Filed 4–20–15; 8:45 am] 

BILLING CODE 4164–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Committee on Rural 

Health and Human Services; Notice of 

Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), announcement is 

made of the following National 

Advisory body scheduled to meet 

during the month of May 2015. 

The National Advisory Committee on 

Rural Health and Human Services will 

convene its seventy seventh meeting in 

the time and place specified below: 

Name: National Advisory Committee 

on Rural Health and Human Services. 

Dates and Time: May 27, 2015, 8:45 

a.m.—5:00 p.m.; May 28, 2015, 8:30 

a.m.—5:15 p.m.; May 29, 2015, 8:30 

a.m.—11:00 a.m. 

Place: Natural Bridge State Park, 2135 

Natural Bridge Rd, Slade, KY 40376, 

(606) 663–2214. 

Status: The meeting will be open to 

the public. 

Purpose: The National Advisory 

Committee on Rural Health and Human 

Services provides counsel and 

recommendations to the Secretary with 

respect to the delivery, research, 

development, and administration of 

health and human services in rural 

areas. 

Agenda: Wednesday morning, at 8:45 

a.m., the meeting will be called to order 

by the Chairperson of the Committee: 

The Honorable Ronnie Musgrove. The 

Committee will examine the issue of an 

increasing difference between life 

expectancy among the urban and rural 

populations of the United States. The 

day will conclude with a period of 

public comment at approximately 4:45 

p.m. 

Thursday morning at approximately 

8:30 a.m., the Committee will break into 

Subcommittees and depart for site 

visits. Subcommittees will visit the 

Center of Excellence in Rural Health in 

Hazard, Kentucky, and the Marcum & 

Wallace Memorial Hospital in Irvine, 

Kentucky. The day will conclude at the 

Natural Bridge State Park with a period 

of public comment at approximately 

5:00 p.m. 

Friday morning at 8:30 a.m., the 

Committee will meet to summarize key 

findings and develop a work plan for 

the next quarter and the following 

meeting. 

FOR FURTHER INFORMATION CONTACT: 

Steve Hirsch, MSLS, Executive 

Secretary, National Advisory Committee 

on Rural Health and Human Services, 

Health Resources and Services 

Administration, Parklawn Building, 

17W29–C, 5600 Fishers Lane, Rockville, 

MD 20857, Telephone (301) 443–0835, 

Fax (301) 443–2803. 

Persons interested in attending any 

portion of the meeting should contact 

Catherine Fontenot at the Federal Office 

of Rural Health Policy (FORHP) via 

telephone at (301) 945–0897 or by email 

at cfontenot@hrsa.gov. The Committee 


tkelley on DSK3SPTVN1PROD with NOTICES