15700 Federal Register / Vol. 72, No. 62 / Monday, April 2, 2007 / Notices 

505(b) of the act: June 15, 2004. The 

applicant claims May 14, 2004, as the 

date the biologics license application 

(BLA) for KEPIVANCE (BLA 125103) 

was initially submitted. However, FDA 

records indicate that the final 

reviewable unit of BLA 125103 was 

submitted on June 15, 2004. 

3. The date the application was 

approved: December 15, 2004. FDA has 

verified the applicant’s claim that BLA 

125103 was approved on December 15, 

2004. 

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 1,417 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) written or 

electronic comments and ask for a 

redetermination by June 1, 2007. 

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 

October 1, 2007. 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. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. 

Comments and petitions may be seen in 

the Division of Dockets Management 

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

through Friday. 

Dated: February 26, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–6053 Filed 3–30–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003E–0256] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; RANEXA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

RANEXA and is publishing this notice 

of that determination as required by 

law. FDA has made the determination 

because of the submission of an 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human drug product. 

ADDRESSES: Submit written comments 

and petitions to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments to http:// 

www.fda.gov/dockets/ecomments. 

FOR FURTHER INFORMATION CONTACT: 

Beverly Friedman, Office of Regulatory 

Policy (HFD–7), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 301–594–2041. 

SUPPLEMENTARY INFORMATION: The Drug 

Price Competition and Patent Term 

Restoration Act of 1984 (Public Law 98–

417) and the Generic Animal Drug and 

Patent Term Restoration Act (Public 

Law 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 human drug 

product 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 RANEXA 

(ranolazine). RANEXA is indicated for 

treatment of chronic angina. Subsequent 

to this approval, the Patent and 

Trademark Office received a patent term 

restoration application for RANEXA 

(U.S. Patent No. 4,567,264) from Roche 

Palo Alto, L.L.C., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated September 5, 2006, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of RANEXA 

represented the first permitted 

commercial marketing or use of the 

product. Shortly 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 

RANEXA is 6,770 days. Of this time, 

5,645 days occurred during the testing 

phase of the regulatory review period, 

while 1,125 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 act) (21 U.S.C. 

355(i)) became effective: July 18, 1987. 

The applicant claims July 10, 1987, as 

the date the investigational new drug 

application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was July 18, 1987, 

which was 30 days after FDA receipt of 

the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 30, 2002. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

RANEXA (NDA 21–526) was initially 

submitted on December 30, 2002. 

3. The date the application was 

approved: January 27, 2006. FDA has 

verified the applicant’s claim that NDA 

21–526 was approved on January 27, 

2006. 

This determination of the regulatory 

review period establishes the maximum 

potential length of a patent extension. 


hsrobinson on PROD1PC76 with NOTICES
Federal Register / Vol. 72, No. 62 / Monday, April 2, 2007 / Notices 15701 

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 5 years 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) written or 

electronic comments and ask for a 

redetermination by June 1, 2007. 

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 

October 1, 2007. 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. 

Comments and petitions should be 

submitted to the Division of Dockets 

Management. Three copies of any 

mailed information are to be submitted, 

except that individuals may submit one 

copy. Comments are to be identified 

with the docket number found in 

brackets in the heading of this 

document. Comments and petitions may 

be seen in the Division of Dockets 

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

Monday through Friday. 

Dated: March 12, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–6061 Filed 3–30–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

The 10th Annual Food and Drug 

Administration-Orange County 

Regulatory Affairs Educational 

Conference 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of meeting. 

The Food and Drug Administration 

(FDA) is announcing the following 

conference: 10th Annual Educational 

Conference co-sponsored with the 

Orange County Regulatory Affairs 

Discussion Group (OCRA). The 

conference is intended to provide the 

Drug, Device, and Biologics industries 

with an opportunity to interact with 

FDA reviewers and compliance officers 

from the Centers and District Offices, as 

well as other industry experts. The main 

focus of this interactive conference will 

be product approval, compliance, and 

risk management in the three medical 

product areas. Industry speakers, 

interactive questions and answers, and 

workshop sessions will also be included 

to assure open exchange and dialogue 

on the relevant regulatory issues. 

Date and Time: The conference will 

be held on June 11 and 12, 2007, from 

7:30 a.m. to 5 p.m. 

Location: The conference will be held 

at the Irvine Marriott, 18000 Von 

Karman Ave., Irvine, CA 92612. 

Contact: Linda Hartley, Food and 

Drug Administration, 19701 Fairchild, 

Irvine, CA 92612, 949–608–4413, FAX: 

949–608–4417, or OCRA, Attention to 

Detail (ATD), 5319 University Dr., suite 

641, Irvine, CA 92612, 949–387–9046, 

FAX: 949–387–9047, Web site: 

www.ocra-dg.org. 

Registration and Meeting Information: 

See OCRA Web site, www.ocra-dg.org. 

Contact ATD at 949–387–9046. 

Before May 11, 2007, registrations fees 

are as follows: $575.00 for members, 

$625.00 for non-members and $400.00 

for FDA/Govt/Students. After May 11, 

2007, $625.00 for members, $725.00 for 

non-members, and $400.00 for FDA/ 

Govt/Students. 

OCRA student rate applies to those 

individuals enrolled in a Regulatory or 

Quality related academic program at an 

accredited institution. Proof of 

enrollment required. 

The registration fee will cover actual 

expenses including refreshments, lunch, 

materials, parking and speaker 

expenses. If you need special 

accommodations due to a disability, 

please contact Linda Hartley at least 10 

days in advance. 

Dated: March 26, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–6052 Filed 3–30–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0114] 

Electronic Distribution of Prescribing 

Information for Prescription Drug 

Products; Public Hearing; Request for 

Comments 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public hearing; request 

for comments. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing a 

public hearing to solicit views and 

information from interested parties 

concerning the concept of electronic 

distribution of FDA-approved 

prescribing information currently 

contained in the package insert (or PIs) 

for human prescription drug and 

biological products. In particular, FDA 

is seeking views and information on the 

feasibility of establishing a modern and 

efficient process for industry to 

electronically distribute prescribing 

information to dispensers. We are 

seeking input on a number of questions 

regarding the current use of package 

inserts and those logistical issues 

associated with electronic distribution 

of such prescribing information. 

DATES: Public Hearing: The public 

hearing will be held on April 27, 2007, 

from 9 a.m. to 5 p.m. However, 

depending on the level of public 

participation, the public hearing may be 

extended later or may end early. If you 

need special accommodations due to a 

disability, please contact Erik Mettler 

(see FOR FURTHER INFORMATION CONTACT) 

by April 20, 2007. 

Registration: Seating at the public 

hearing is limited. Registration is free 

and will be on a first-come, first-serve 

basis. Persons interested in attending 

the public hearing should register by 

close of business on April 20, 2007. 

Notice of Oral Presentation: Persons 

interested in presenting responses to the 

questions should submit a notice of oral 

presentation by close of business on 

April 17, 2007. See section I of this 

document for information on how to 

participate in the public hearing. 

Comments: Submit written or 

electronic comments by June 22, 2007. 

ADDRESSES: Public Hearing: The public 

hearing will be held at 5600 Fishers 

Lane, third Fl., conference rooms D & E, 

Rockville, MD 20857. 

Registration: Submit written 

registration to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic registration to http:// 

www.accessdata.fda.gov/scripts/oc/ 

dockets/meetings/meetingdocket.cfm. 

Notice of Oral Presentation and 

Comments: Submit written notices of 

oral presentation and comments to the 

Division of Dockets Management (see 

previous paragraph). Submit electronic 

notices of oral presentation and 

comments to http:// 

www.accessdata.fda.gov/scripts/oc/ 

dockets/comments/commentdocket.cfm. 

Identify all submissions to the docket 

with the docket number found in 


hsrobinson on PROD1PC76 with NOTICES