14028 Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices 

a disability, please contact Paul Tran at 

least 7 days in advance of the meeting. 

FDA is committed to the orderly 

conduct of its advisory committee 

meetings. Please visit our Web site at 

http://www.fda.gov/ 

AdvisoryCommittees/ 

AboutAdvisoryCommittees/ 

ucm111462.htm for procedures on 

public conduct during advisory 

committee meetings. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5901 Filed 3–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0381] 

Generic Drug User Fee; Notice of 

Public Meeting; Reopening of the 

Comment Period 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice; reopening of the 

comment period. 

SUMMARY: The Food and Drug 

Administration (FDA) is reopening until 

June 30, 2011, the comment period for 

the notice of public meeting, published 

in the Federal Register of August 9, 

2010 (75 FR 47820), entitled ‘‘Generic 

Drug User Fee; Public Meeting; Request 

for Comments.’’ In that notice, FDA 

announced a public meeting that took 

place on September 17, 2010, to gather 

stakeholder input on the development 

of a generic drug user fee program. FDA 

is reopening the comment period for the 

expected duration of the active 

negotiation phase to ensure that all 

interested stakeholders have the 

opportunity to share their views on the 

matter. 

DATES: Submit either electronic or 

written comments by June 30, 2011. 

ADDRESSES: 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. 

FOR FURTHER INFORMATION CONTACT: 

Peter C. Beckerman, Office of Policy, 

Food and Drug Administration, 10903 

New Hampshire Ave., Bldg. 32, rm. 

4238, Silver Spring, MD 20993, 301– 

796–4830, FAX: 301–847–3541, e-mail: 

peter.beckerman@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the Federal Register of August 9, 

2010 (75 FR 47820), FDA published a 

notice of a public meeting on the 

development of a generic drug user fee 

(GDUF) program. In that notice, FDA 

posed several questions related to a user 

fee for human generic drugs and sought 

public input on such a program. The 

Agency received submissions and 

presentations from the public meeting, 

which are now posted on FDA’s Web 

site. On November 4, 2010 (75 FR 

67984), FDA subsequently reopened the 

comment period for 30 days to allow 

consideration of submissions received 

after the original docket closing date. 

Because after that reopening FDA 

received multiple requests to reopen the 

docket, including requests from generic 

industry segments that did not 

previously comment, FDA reopened the 

docket again to permit public input on 

all the submissions. 

Interested persons were originally 

given until October 17, 2010, to 

comment on the development of a 

generic drug user fee program. In the 

last docket reopening on January 24, 

2011 (76 FR 4119), FDA reopened the 

docket to permit comments until 

February 23, 2011. 

To ensure that all interested persons, 

whether a member of a trade 

organization at the negotiating table or 

not, have sufficient opportunity to share 

their views on the GDUF program 

throughout the negotiation phase, FDA 

is reopening the comment period until 

June 30, 2011. FDA expects that the 

public component of the GDUF 

negotiations will be complete by the end 

of June 2011. Therefore, the Agency is 

reopening the comment period for this 

anticipated duration. 

II. Additional Information on GDUF 

There is information on FDA’s Web 

site that may be useful for interested 

stakeholders to better understand FDA’s 

effort to establish a generic drug user fee 

and its current status. Information on 

the September 17, 2010, public meeting 

on GDUF, the Federal Register notice 

announcing the meeting, the transcript 

of the meeting, and slide presentations 

from the meeting are available at 

http://www.fda.gov/Drugs/NewsEvents/ 

ucm224121.htm. Additional 

information on that Web page includes 

subsequent FDA updates, slide 

presentations, and speeches related to 

generic drug user fees, and this is also 

where FDA will post meeting minutes 

from the negotiation sessions with 

industry. 

III. How To Submit Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) either electronic or written 

comments regarding this document. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send two copies of mailed 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. 

Dated: March 9, 2011. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2011–5917 Filed 3–14–11; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2011–N–0122] 

Center for Devices and Radiological 

Health 510(k) Implementation: Online 

Repository of Medical Device Labeling, 

Including Photographs; Public Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing a public meeting 

entitled ‘‘510(k) Implementation: 

Discussion of an Online Repository of 

Medical Device Labeling and of Making 

Device Photographs Available in a 

Public Database Without Disclosing 

Proprietary Information.’’ The purpose 

of the meeting is to obtain public 

comment on the following topics: FDA’s 

plans to establish an online public 

repository of medical device labeling 

and strategies for displaying device 

photographs in a public database 

without disclosing proprietary 

information. 

DATES: Date and Time: The public 

meeting will be held on April 7, 2011, 

from 8:30 a.m. to 5 p.m. 

Location: The public meeting will be 

held at the FDA White Oak Campus, 

10903 New Hampshire Ave., Bldg. 31, 

rm. 1503, Silver Spring, MD 20903. 

Contact Person: Joyce Siwarski, 

Center for Devices and Radiological 

Health, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 66, 

rm. 5402, Silver Spring, MD 20903, 


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