22204 Federal Register / Vol. 80, No. 76 / Tuesday, April 21, 2015 / Notices 

Dated: April 15, 2015. 

Leslie Kux, 

Associate Commissioner for Policy. 

[FR Doc. 2015–09092 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–2012–N–0882] 

Generic Drug User Fees; Public 

Meeting; Request for Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public meeting on the Generic Drug 

User Fee Amendments of 2012 

(GDUFA). The legislative authority for 

GDUFA expires at the end of September 

2017. At that time, new legislation will 

be required for FDA to continue to 

collect generic drug user fees for future 

fiscal years. The Federal Food, Drug, 

and Cosmetic Act (the FD&C Act) 

requires that before FDA begins 

negotiations with the regulated industry 

on GDUFA reauthorization; we publish 

a notice in the Federal Register 

requesting public input on the 

reauthorization, hold a public meeting 

at which the public may present its 

views on the reauthorization, including 

specific suggestions for changes to the 

goals referred to in the Generic Drug 

User Fee Act Program Performance 

Goals and Procedures (i.e., the 

Commitment Letter), provide a period of 

30 days after the public meeting to 

obtain written comments from the 

public, and publish the comments on 

FDA’s Web site. FDA invites public 

comment on the GDUFA program and 

suggestions regarding the features FDA 

should propose for the next GDUFA 

program. 

DATES: The public meeting will be held 

on June 15, 2015, from 9 a.m. to 5 p.m. 

The public meeting may be extended or 

may end early depending on the level of 

public participation. 

ADDRESSES: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31 

Conference Center, the Great Room (Rm. 

1503), Silver Spring, MD 20993–0002. 

Entrance for the public meeting 

participants (non-FDA employees) is 

through Building 1, where routine 

security check procedures will be 

performed. For parking and security 

information, refer to http://

www.fda.gov/AboutFDA/

WorkingatFDA/BuildingsandFacilities/

WhiteOakCampusInformation/

ucm241740.htm. 

FOR FURTHER INFORMATION CONTACT: 

Connie Wisner, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1718, 

Silver Spring, MD 20993, 240–402– 

7946, Connie.Wisner@fda.hhs.gov; or 

Kimberly Giordano, Center for Drug 

Evaluation and Research, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 75, Rm. 1611, 

Silver Spring, MD 20993, 301–796– 

1071, Kimberly.Giordano@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

On July 9, 2012, the Food and Drug 

Administration Safety and Innovation 

Act, which included GDUFA (Pub. L. 

112–144, title III), was signed into law 

by the President. GDUFA authorizes 

FDA to collect fees from drug 

companies that submit marketing 

applications for certain generic human 

drug applications, certain drug master 

files, and certain facilities. Designed to 

speed access to safe and effective 

generic drugs to the public, GDUFA 

requires that generic drug manufacturers 

pay user fees to finance critical and 

measurable generic drug program 

enhancements. GDUFA also requires 

that generic drug facilities around the 

world provide identification 

information annually to FDA. 

Additional information concerning 

GDUFA, including the text of the law, 

the Commitment Letter, key Federal 

Register documents, GDUFA-related 

guidances, performance reports, and 

financial reports may be found on the 

FDA Web site at http://www.fda.gov/

gdufa. 

II. Purpose of Public Meeting 

FDA is announcing a public meeting 

on GDUFA. The authority for GDUFA 

expires at the end of September 2017. 

Without new legislation, FDA will no 

longer be able to collect user fees to 

fund the human generic drug review 

process. Section 744(C)(d)(2) (21 U.S.C. 

379j–43(d)(2)) of the FD&C Act requires 

that before FDA begins negotiations 

with the regulated industry on GDUFA 

reauthorization, we do the following: (1) 

Publish a notice in the Federal Register 

requesting public input on the 

reauthorization, (2) hold a public 

meeting at which the public may 

present its views on the reauthorization, 

including specific suggestions for 

changes to the goals referred to in the 

Commitment Letter, (3) provide a period 

of 30 days after the public meeting to 

obtain written comments from the 

public, and (4) publish the comments on 

the FDA Web site. This notice, the 

public meeting, the 30-day comment 

period after the meeting, and the posting 

of the comments on the FDA Web site 

will satisfy these requirements. The 

purpose of the public meeting is to 

receive public input on the 

reauthorization of GDUFA, including 

specific suggestions for changes to the 

goals referred to in the Commitment 

Letter. FDA is interested in responses to 

the following two general questions and 

welcomes any other relevant 

information the public would like to 

share: 

• What is your assessment of the 

overall performance of the GDUFA 

program to date? 

• What aspects of GDUFA should be 

retained, changed, or discontinued to 

further strengthen and improve the 

program? 

In general, the meeting format will 

include presentations by FDA, scientific 

and academic experts, health care 

professionals, representatives of patient 

and consumer advocacy groups, the 

generic drug industry, and the general 

public. The amount of time available for 

public testimony will be determined by 

the number of persons who register to 

present at the meeting. A draft agenda 

and other background information for 

the public meeting will be posted at 

http://www.fda.gov/gdufa by June 8, 

2015. 

III. Meeting Attendance and 

Participation 

FDA is seeking participation (i.e., 

attendance and oral presentations) at the 

public meeting by all interested parties, 

including but not limited to scientific 

and academic experts, health care 

professionals, representatives of patient 

and consumer advocacy groups, the 

generic drug industry, and the general 

public. If you wish to attend the 

meeting, please email your registration 

information to GenericDrugPolicy@

fda.hhs.gov by June 1, 2015. Your email 

should contain complete contact 

information for each attendee, including 

name, title, affiliation, address, email 

address, and telephone number. 

Registration is free and is on a firstcome, first-served basis. Early 

registration is recommended because 

seating is limited. Registrants will 

receive confirmation once they have 

been accepted. If registration becomes 

full prior to the meeting, FDA will place 

a notice on http://www.fda.gov/gdufa. 

Onsite registration on the day of the 


tkelley on DSK3SPTVN1PROD with NOTICES
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