76992 Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices 

3. The date the application was 

approved: July 1, 2009. FDA has verified 

the applicant’s claim that NDA 21–425 

for MULTAQ was approved on July 1, 

2009. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 

However, the U.S. Patent and 

Trademark Office applies several 

statutory limitations in its calculations 

of the actual period for patent extension. 

In its applications for patent extension, 

this applicant seeks 519 days and 5 

years, respectively, of patent term 

extension. 

Anyone with knowledge that any of 

the dates as published are incorrect may 

submit to the Division of Dockets 

Management (see ADDRESSES) either 

electronic or written comments and ask 

for a redetermination by February 8, 

2011. Furthermore, any interested 

person may petition FDA for a 

determination regarding whether the 

applicant for extension acted with due 

diligence during the regulatory review 

period by June 8, 2011. To meet its 

burden, the petition must contain 

sufficient facts to merit an FDA 

investigation. (See H. Rept. 857, part 1, 

98th Cong., 2d sess., pp. 41–42, 1984.) 

Petitions should be in the format 

specified in 21 CFR 10.30. 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) electronic or written 

comments and written petitions. It is 

only necessary to send one set of 

comments. It is no longer necessary to 

send three copies of mailed comments. 

However, if you submit a written 

petition, you must submit three copies 

of the petition. Identify comments with 

the docket number found in brackets in 

the heading of this document. 

Comments and petitions that have not 

been made publicly available on 

regulations.gov may be viewed in the 

Division of Dockets Management 

between 9 a.m. and 4 p.m., Monday 

through Friday. 

Dated: October 22, 2010. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. 2010–31064 Filed 12–9–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2005–D–0072] (formerly 

Docket No. 2005D–0042) 

Guidance for the Public, FDA Advisory 

Committee Members, and FDA Staff: 

The Open Public Hearing at FDA 

Advisory Committee Meetings; 

Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance entitled 

‘‘Guidance for the Public, FDA Advisory 

Committee Members, and FDA Staff: 

The Open Public Hearing at FDA 

Advisory Committee Meetings.’’ We are 

issuing the guidance to provide 

information on how the public may 

participate at the open public hearing 

(OPH) portion of FDA advisory 

committee meetings. The guidance also 

provides recommendations regarding 

financial disclosure by persons 

participating in the OPH portion of 

advisory committee meetings. 

DATES: Submit electronic or written 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written requests for 

single copies of this guidance to the 

Office of Special Medical Programs, 

Office of the Commissioner, Food and 

Drug Administration, 10903 New 

Hampshire Ave., Bldg. 32, rm. 5103, 

Silver Spring, MD 20993. Send one selfaddressed adhesive label to assist that 

office in processing your request. See 

the SUPPLEMENTARY INFORMATION section 

for electronic access to the guidance. 

Submit electronic comments on the 

guidance to http://www.regulations.gov. 

Submit written comments on the 

guidance to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. 

FOR FURTHER INFORMATION CONTACT: 

Michael Ortwerth, Office of Special 

Medical Programs, Office of the 

Commissioner, Food and Drug 

Administration, 10903 New Hampshire 

Ave., Bldg. 32, rm. 5103, Silver Spring, 

MD 20993, e-mail: 

Michael.Ortwerth@fda.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

I. Background 

In the February 15, 2005, issue of the 

Federal Register (70 FR 7747), FDA 

issued a notice announcing the 

availability of a draft guidance entitled 

‘‘The Open Public Hearing; FDA 

Advisory Committee Meetings.’’ The 

guidance is intended for members of the 

public who choose to participate in the 

OPH portion of an FDA advisory 

committee meeting. 

FDA issues guidance documents for 

FDA staff, applicants and sponsors of 

regulated products, and the public that 

describe the agency’s current thinking 

on a regulatory matter, including its 

interpretation of, and policies regarding, 

statutes and regulations. FDA’s advisory 

committees provide independent expert 

advice and recommendations to the 

agency on scientific, technical, and 

policy matters related to FDA-regulated 

products. Although advisory 

committees provide recommendations 

to FDA, FDA makes the final decisions 

on any matters considered by an 

advisory committee (21 CFR 14.5). 

Under 21 CFR 14.25(a), every meeting of 

an FDA advisory committee includes an 

OPH session during which interested 

persons may present relevant 

information or views orally or in 

writing. The hearing session is 

conducted in accordance with the 

procedures set forth in 21 CFR 14.29. 

FDA encourages participation from all 

public stakeholders in our 

decisionmaking processes. We issued 

the draft guidance to answer questions 

about how the public may participate at 

an OPH session. Participants may 

include, but are not limited to, general 

members of the public, individuals or 

spokespersons from the regulated 

industry, consumer advocacy groups, 

and professional organizations, 

societies, and associations. The 

guidance provides information on such 

matters as how to submit a request to 

speak at an OPH session, logistical 

procedures, and disclosure of financial 

relationships relevant to the meeting 

topic. 

We received two comments on the 

draft guidance. In response to the 

comments and at our own initiative, we 

have revised the guidance in several 

respects, including with regard to how 

the OPH session is conducted and 

instructions regarding financial 

disclosure. 

This guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The guidance represents the agency’s 

thinking on participation in the OPH 

portion of FDA advisory committee 

meetings. 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 

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Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices 76993 

requirements of the applicable statutes 

and regulations. 

II. 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. 

III. Electronic Access 

Persons with access to the Internet 

may obtain the guidance at http:// 

www.fda.gov/oc/advisory/default.htm. 

Dated: December 6, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31022 Filed 12–9–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2010–N–0001] 

Tobacco Products Scientific 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: Tobacco Products 

Scientific 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 January 10 and 11, 2011 from 8 a.m. until 

5 p.m. 

Location: FDA White Oak Conference 

Center, Bldg. 31, rm. 1503, 10903 New 

Hampshire Ave., 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 have a valid 

driver’s license or other picture ID, and must 

enter through Building 1. 

Contact Person: Caryn Cohen, Office of 

Science, Center for Tobacco Products, Food 

and Drug Administration, 9200 Corporate 

Blvd., Rockville, MD 20850, 1–877–287–1373 

(choose Option 4), e-mail: 

TPSAC@fda.hhs.gov, or FDA Advisory 

Committee Information Line, 1–800–741– 

8138 (301–443–0572 in the Washington, DC 

area), code 8732110002. 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 January 10 and 11, 2011, the 

Committee will continue to (1) receive 

updates from the Menthol Report 

Subcommittee and (2) receive and discuss 

presentations regarding the data requested by 

the Committee at the March 30 and 31, 2010, 

meeting of the Tobacco Products Scientific 

Advisory Committee. 

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 

December 30, 2010. Oral presentations from 

the public will be scheduled between 

approximately 3 p.m. and 4 p.m. on January 

10, 2011. 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 December 21, 2010. 

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 December 22, 2010. 

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 Caryn 

Cohen 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: December 3, 2010. 

Leslie Kux, 

Acting Assistant Commissioner for Policy. 

[FR Doc. 2010–31066 Filed 12–9–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

National Institutes of Health 

Submission for OMB Review; 

Comment Request; Generic Clearance 

for Surveys of Customers and Partners 

of the Office of Extramural Research of 

the National Institutes of Health 

SUMMARY: Under the provisions of 

Section 3507(a)(1)(D) of the Paperwork 

Reduction Act of 1995, the Office of 

Extramural Research (OER), the 

National Institutes of Health (NIH) has 

submitted to the Office of Management 

and Budget (OMB) a request for review 

and approval of the information 

collection listed below. This proposed 

information collection was previously 

published in the Federal Register on 

September 13, 2010 (Volume 75, 

Number 176, page 55585) and allowed 

60 days for public comment. One public 

comment was received. The purpose of 

this notice is to allow an additional 30 

days for public comment. The National 

Institutes of Health may not conduct or 

sponsor, and the respondent is not 

required to respond to, an information 

collection that has been extended, 

revised, or implemented on or after 

October 1, 1995, unless it displays a 

currently valid OMB control number. 

Proposed Collection: Title: Generic 

Clearance for Surveys of Customers and 

Partners of the Office of Extramural 

Research of the National Institutes of 

Health. Type of Information Collection 

Request: NEW. Need and Use of 

Information Collection: OER develops, 

coordinates the implementation of, and 

evaluates NIH-wide policies and 

procedures for the award of extramural 

funds . To move forward with our 

initiatives to ensure success in 

accomplishing the NIH mission, input 

from partners and customers is 

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