Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Notices 10597 

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.regulations.gov. 

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 (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 animal drug 

products, the testing phase begins on 

the earlier date when either a major 

environmental effects test was initiated 

for the drug or when an exemption 

under section 512(j) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

360b(j)) became effective and runs until 

the approval phase begins. The approval 

phase starts with the initial submission 

of an application to market the animal 

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 

an animal drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(4)(B). 

FDA recently approved for marketing 

the animal drug product CERENIA 

INJECTABLE SOLUTION (maropitant). 

CERENIA INJECTABLE SOLUTION is 

indicated for the prevention and 

treatment of acute vomiting in dogs. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

CERENIA INJECTABLE SOLUTION 

(U.S. Patent No. 6,222,038) from Pfizer 

Inc., and the Patent and Trademark 

Office requested FDA’s assistance in 

determining this patent’s eligibility for 

patent term restoration. In a letter dated 

May 6, 2008, FDA advised the Patent 

and Trademark Office that this animal 

drug product had undergone a 

regulatory review period and that the 

approval of CERENIA INJECTABLE 

SOLUTION 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 

CERENIA INJECTABLE SOLUTION is 

1,887 days. Of this time, 1,841 days 

occurred during the testing phase of the 

regulatory review period, while 46 days 

occurred during the approval phase. 

These periods of time were derived from 

the following dates: 

1. The date an exemption under 

section 512(j) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360b(j)) 

became effective: December 1, 2001. The 

applicant claims June 28, 2000, as the 

date the investigational new animal 

drug application (INAD) became 

effective. However, the date that a major 

health or environmental effects test is 

begun or the date on which the agency 

acknowledges the filing of a notice of 

claimed investigational exemption for a 

new animal drug, whichever is earlier, 

is the effective date for the INAD. 

According to FDA records, December 1, 

2001, is the effective date for the INAD. 

2. The date the application was 

initially submitted with respect to the 

animal drug product under section 512 

of the Federal Food, Drug, and Cosmetic 

Act: December 15, 2006. The applicant 

claims December 13, 2006, as the date 

the new animal drug application 

(NADA) for CERENIA INJECTABLE 

SOLUTION (NADA 141–263) was 

initially submitted. However, a review 

of FDA records reveals that NADA 141– 

263 was initially submitted on 

December 15, 2006. 

3. The date the application was 

approved: January 29, 2007. FDA has 

verified the applicant’s claim that 

NADA 141–263 was approved on 

January 29, 2007. 

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 1,078 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 May 11, 2009. 

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 

September 8, 2009. 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 17, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–5112 Filed 3–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2007–E–0230] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CERENIA TABLETS 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

CERENIA TABLETS 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 

animal 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 


rwilkins on PROD1PC63 with NOTICES
10598 Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Notices 

electronic comments to http:// 

www.regulations.gov. 

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 (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 animal drug 

products, the testing phase begins on 

the earlier date when either a major 

environmental effects test was initiated 

for the drug or when an exemption 

under section 512(j) of the Federal Food, 

Drug, and Cosmetic Act (21 U.S.C. 

360b(j)) became effective and runs until 

the approval phase begins. The approval 

phase starts with the initial submission 

of an application to market the animal 

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 

an animal drug product will include all 

of the testing phase and approval phase 

as specified in 35 U.S.C. 156(g)(4)(B). 

FDA recently approved for marketing 

the animal drug product CERENIA 

TABLETS (maropitant citrate 

monohydrate). CERENIA TABLETS is 

indicated for the prevention of acute 

vomiting in dogs and the prevention of 

vomiting due to motion sickness in 

dogs. Subsequent to this approval, the 

Patent and Trademark Office received a 

patent term restoration application for 

CERENIA TABLETS (U.S. Patent No. 

6,255,320) from Pfizer Inc., and the 

Patent and Trademark Office requested 

FDA’s assistance in determining this 

patent’s eligibility for patent term 

restoration. In a letter dated May 6, 

2008, FDA advised the Patent and 

Trademark Office that this animal drug 

product had undergone a regulatory 

review period and that the approval of 

CERENIA TABLETS 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 

CERENIA TABLETS is 1,887 days. Of 

this time, 1,841 days occurred during 

the testing phase of the regulatory 

review period, while 46 days occurred 

during the approval phase. These 

periods of time were derived from the 

following dates: 

1. The date an exemption under 

section 512(j) of the Federal Food, Drug, 

and Cosmetic Act (21 U.S.C. 360b(j)) 

became effective: December 1, 2001. The 

applicant claims November 21, 2000, as 

the date the investigational new animal 

drug application (INAD) became 

effective. However, the date that a major 

health or environmental effects test is 

begun or the date on which the agency 

acknowledges the filing of a notice of 

claimed investigational exemption for a 

new animal drug, whichever is earlier, 

is the effective date for the INAD. 

According to FDA records, December 1, 

2001, is the effective date for the INAD. 

2. The date the application was 

initially submitted with respect to the 

animal drug product under section 512 

of the Federal Food, Drug, and Cosmetic 

Act: December 15, 2006. The applicant 

claims December 13, 2006, as the date 

the new animal drug application 

(NADA) for CERENIA TABLETS (NADA 

141–262) was initially submitted. 

However, a review of FDA records 

reveals that NADA 141–262 was 

initially submitted on December 15, 

2006. 

3. The date the application was 

approved: January 29, 2007. FDA has 

verified the applicant’s claim that 

NADA 141–262 was approved on 

January 29, 2007. 

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 267 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 May 11, 2009. 

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 

September 8, 2009. 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 17, 2009. 

Jane A. Axelrad, 

Associate Director for Policy, Center for Drug 

Evaluation and Research. 

[FR Doc. E9–5109 Filed 3–10–09; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. FDA–2009–D–0060] 

Guidance for Industry: Measures to 

Address the Risk for Contamination by 

Salmonella Species in Food 

Containing a Peanut-Derived Product 

as an Ingredient; 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 Industry: Measures to 

Address the Risk for Contamination by 

Salmonella Species in Food Containing 

a Peanut-Derived Product as an 

Ingredient.’’ This guidance is intended 

to clarify for manufacturers who 

produce foods containing a peanutderived product as an ingredient that 

there is a risk that Salmonella species 

may be present in the incoming peanutderived product, and to recommend 

measures to address that risk. 

DATES: Submit written or electronic 

comments on agency guidances at any 

time. 

ADDRESSES: Submit written comments 

on the guidance to the Division of 


rwilkins on PROD1PC63 with NOTICES