28496 Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 

and 1 for products regulated by CBER. 

FDA anticipates that approximately 7 

applicants (respondents) will submit 

these Pilot 2 applications annually to 

CDER and approximately 1 applicant 

(respondent) will submit these Pilot 2 

applications annually to CBER. The 

hours per response, which is the 

estimated number of hours that a 

respondent would spend preparing the 

information to be submitted in a Pilot 2 

application in accordance with the 

guidance, is estimated to be 

approximately 80 hours. Based on 

FDA’s experience, we expect it will take 

respondents this amount of time to 

obtain and draft the information to be 

submitted with a Pilot 2 application. 

Therefore, the agency estimates that 

applicants use approximately 640 hours 

annually to submit the Pilot 2 

applications. 

In the Federal Register of July 24, 

2006 (71 FR 41819), FDA published a 

60-day notice requesting public 

comment on the information collection 

provisions. No comments were received. 

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Pilot 2 Application No. of 

Respondents 

No. of 

Responsesper Response Total Responses Hours per 

Response Total Hours 

CDER 7 1 7 80 560 

CBER 1 1 1 80 80 

Total 640 

1There are no capital costs or operating and maintenance costs associated with this collection of information. 

Dated: May 15, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–9709 Filed 5–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007E–0066] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; NOXAFIL 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

NOXAFIL 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–007), 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 NOXAFIL 

(posaconazole). NOXAFIL is indicated 

for prophylaxis of invasive Aspergillus 

and Candida infections in patients, 13 

years of age and older, who are at high 

risk of developing these infections due 

to being severely immunocompromised, 

such as hematopoietic stem cell 

transplant recipients with Graft versus 

Host Disease or those with hematologic 

malignancies with prolonged 

neutropenia from chemotherapy. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

NOXAFIL (U.S. Patent No. 5,661,151) 

from Schering Corp., and the Patent and 

Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated March 12, 2007, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of NOXAFIL 

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 

NOXAFIL is 3,650 days. Of this time, 

3,382 days occurred during the testing 

phase of the regulatory review period, 

while 268 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: September 19, 

1996. The applicant claims November 6, 

1996, as the date the investigational new 

drug application (IND) became effective. 

However, FDA records indicate that the 

IND effective date was September 19, 

1996, which was 30 days after FDA 

receipt of the first IND. 


pwalker on PROD1PC71 with NOTICES
Federal Register / Vol. 72, No. 97 / Monday, May 21, 2007 / Notices 28497 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: December 22, 2005. 

The applicant claims December 21, 

2005, as the date the new drug 

application (NDA) for NOXAFIL (NDA 

22–003) was initially submitted. 

However, FDA records indicate that 

NDA 22–003 was submitted on 

December 22, 2005. 

3. The date the application was 

approved: September 15, 2006. FDA has 

verified the applicant’s claim that NDA 

22–003 was approved on September 15, 

2006. 

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 1,789 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 July 20, 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 

November 19, 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: May 7, 2007. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E7–9730 Filed 5–18–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2004E–0398] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; IRESSA 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for IRESSA 

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–007), 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 IRESSA 

(gefitinib). IRESSA is indicated as 

monotherapy for the continued 

treatment of patients with locally 

advanced or metastatic non-small cell 

lung cancer after failure of both 

platinum-based and docetaxel 

chemotherapies who are benefiting or 

have benefited from IRESSA. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for IRESSA 

(U.S. Patent No. 5,770,599) from 

AstraZeneca UK Limited, and the Patent 

and Trademark Office requested FDA’s 

assistance in determining this patent’s 

eligibility for patent term restoration. In 

a letter dated October 19, 2004, FDA 

advised the Patent and Trademark 

Office that this human drug product had 

undergone a regulatory review period 

and that the approval of IRESSA 

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 

IRESSA is 1,967 days. Of this time, 

1,693 days occurred during the testing 

phase of the regulatory review period, 

while 274 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: December 17, 

1997. FDA has verified the applicant’s 

claim that the date the investigational 

new drug application became effective 

was on December 17, 1997. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: August 5, 2002. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

Iressa (NDA 21–399) was initially 

submitted on August 5, 2002. 

3. The date the application was 

approved: May 5, 2003. FDA has 

verified the applicant’s claim that NDA 

21–399 was approved on May 5, 2003. 


pwalker on PROD1PC71 with NOTICES