Federal Register / Vol. 75, No. 237 / Friday, December 10, 2010 / Notices 76991 

applicant’s claim that there was no 

investigational new drug application for 

COARTEM. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FD&C act: June 27, 2008. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) 

22–268 was submitted on June 27, 2008. 

3. The date the application was 

approved: April 7, 2009. FDA has 

verified the applicant’s claim that NDA 

22–268 was approved on April 7, 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 application for patent extension, 

this applicant seeks 284 days 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. 2010–31074 Filed 12–9–10; 8:45 am] 

BILLING CODE 4160–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket Nos. FDA–2010–E–0039 and FDA– 

2010–E–0040] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; MULTAQ 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

MULTAQ and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of 

applications to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of patents 

which claim that human drug product. 

ADDRESSES: Submit electronic 

comments to http:// 

www.regulations.gov. Submit written 

petitions along with three copies and 

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: 

Beverly Friedman, Office of Regulatory 

Policy, Food and Drug Administration, 

10903 New Hampshire Ave., Bldg. 51, 

rm. 6222, Silver Spring, MD 20993– 

0002, 301–796–3602. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Pub. L. 98–417) 

and the Generic Animal Drug and Patent 

Term Restoration Act (Pub. L. 100–670) 

generally provide that a patent may be 

extended for a period of up to 5 years 

so long as the patented item (human 

drug product, animal drug product, 

medical device, food additive, or color 

additive) was subject to regulatory 

review by FDA before the item was 

marketed. Under these acts, a product’s 

regulatory review period forms the basis 

for determining the amount of extension 

an applicant may receive. 

A regulatory review period consists of 

two periods of time: A testing phase and 

an approval phase. For human drug 

products, the testing phase begins when 

the exemption to permit the clinical 

investigations of the drug becomes 

effective and runs until the approval 

phase begins. The approval phase starts 

with the initial submission of an 

application to market the human drug 

product and continues until FDA grants 

permission to market the drug product. 

Although only a portion of a regulatory 

review period may count toward the 

actual amount of extension that the 

Director of Patents and Trademarks may 

award (for example, half the testing 

phase must be subtracted as well as any 

time that may have occurred before the 

patent was issued), FDA’s determination 

of the length of a regulatory review 

period for a human drug product will 

include all of the testing phase and 

approval phase as specified in 35 U.S.C. 

156(g)(1)(B). 

FDA recently approved for marketing 

the human drug product MULTAQ 

(dronedarone hydrochloride). MULTAQ 

is indicated to reduce the risk of 

cardiovascular hospitalization in 

patients with paroxysmal or persistent 

atrial fibrillation (AF) or atrial flutter 

(AFL), with a recent episode of AF/AFL 

and associated cardiovascular risk 

factors who are in sinus rhythm or who 

will be cardioverted. Subsequent to this 

approval, the Patent and Trademark 

Office received patent term restoration 

applications for MULTAQ (U.S. Patent 

Nos. 5,223,510 and 7,323,493) from 

Sanofi-Aventis, and the Patent and 

Trademark Office requested FDA’s 

assistance in determining the patents’ 

eligibility for patent term restoration. In 

a letter dated March 3, 2010, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of MULTAQ 

represented the first permitted 

commercial marketing or use of the 

product. Thereafter, the Patent and 

Trademark Office requested that FDA 

determine the product’s regulatory 

review period. 

FDA has determined that the 

applicable regulatory review period for 

MULTAQ is 5,076 days. Of this time, 

3,593 days occurred during the testing 

phase of the regulatory review period, 

while 1,483 days occurred during the 

approval phase. These periods of time 

were derived from the following dates: 

1. The date an exemption under 

section 505(i) of the Federal Food, Drug, 

and Cosmetic Act (the FFD&C act) (21 

U.S.C. 355(i)) became effective: August 

10, 1995. FDA has verified the 

applicant’s claim that the date the 

investigational new drug application 

became effective was on August 10, 

1995. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the FFD&C act: June 10, 2005. 

FDA has verified the applicant’s claim 

that the first new drug application 

(NDA) for MULTAQ (NDA 21–913) was 

submitted on June 10, 2005. 

mstockstill on DSKH9S0YB1PROD with NOTICES

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 

mstockstill on DSKH9S0YB1PROD with NOTICES