Federal Register / Vol. 76, No. 50 / Tuesday, March 15, 2011 / Notices 14027 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before April 13, 2011. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before April 5, 

2011. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 6, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

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. 2011–5900 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–0002] 

Antiviral Drugs Advisory Committee; 

Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Antiviral Drugs 

Advisory Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the Agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on April 28, 2011, from 8 a.m. to 

5 p.m. 

Location: FDA White Oak Campus, 

10903 New Hampshire Ave., Building 

31 Conference Center, the Great Room 

(rm. 1503), Silver Spring, MD 20993– 

0002. Information regarding special 

accommodations due to a disability, 

visitor parking and transportation may 

be accessed at: http://www.fda.gov/ 

AdvisoryCommittees/default.htm; under 

the heading ‘‘Resources for You’’, click 

on ‘‘White Oak Conference Center 

Parking and Transportation Information 

for FDA Advisory Committee Meetings.’’ 

Please note that visitors to the White 

Oak Campus must enter through 

Building 1. 

Contact Person: Paul Tran, Center for 

Drug Evaluation and Research, Food 

and Drug Administration, 10903 New 

Hampshire Ave., Bldg. 31, rm. 2417, 

Silver Spring, MD 20993–0002, 301– 

796–9001, Fax: 301–847–8540, e-mail: 

paul.tran@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), and follow the 

prompts to the desired center or product 

area. Please call the Information Line for 

up-to-date information on this meeting. 

A notice in the Federal Register about 

last minute modifications that impact a 

previously announced advisory 

committee meeting cannot always be 

published quickly enough to provide 

timely notice. Therefore, you should 

always check the Agency’s Web site and 

call the appropriate advisory committee 

hot line/phone line to learn about 

possible modifications before coming to 

the meeting. 

Agenda: On April 28, 2011, the 

committee will discuss a new drug 

application (NDA) 201–917, telaprevir 

(a hepatitis C virus protease inhibitor), 

manufactured by Vertex 

Pharmaceuticals, Inc., with a proposed 

indication for the treatment of chronic 

hepatitis C genotype 1 infection, in 

combination with peginterferon alfa and 

ribavirin (two medicines approved to 

treat chronic hepatitis C infection) in 

adult patients with compensated liver 

disease who are previously untreated or 

who have failed previous therapy. 

Compensated liver disease is a stage in 

which the liver is damaged but 

maintains ability to function. 

FDA intends to make background 

material available to the public no later 

than 2 business days before the meeting. 

If FDA is unable to post the background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

AdvisoryCommittees/Calendar/

default.htm. Scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before April 14, 2011. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those individuals 

interested in making formal oral 

presentations should notify the contact 

person and submit a brief statement of 

the general nature of the evidence or 

arguments they wish to present, the 

names and addresses of proposed 

participants, and an indication of the 

approximate time requested to make 

their presentation on or before April 6, 

2011. Time allotted for each 

presentation may be limited. If the 

number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak by April 7, 2011. 

Persons attending FDA’s advisory 

committee meetings are advised that the 

Agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 


srobinson on DSKHWCL6B1PROD with NOTICES
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, 


srobinson on DSKHWCL6B1PROD with NOTICES