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
Federal Register / Vol. 74, No. 46 / Wednesday, March 11, 2009 / Notices 10599 

Dockets Management (HFA–305), Food 

and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852. 

Submit electronic comments on the 

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

Submit written requests for single 

copies of the guidance to the Office of 

Food Safety, Center for Food Safety and 

Applied Nutrition (HFS–317), Food and 

Drug Administration, 5100 Paint Branch 

Pkwy., College Park, MD 20740. Send 

two self-addressed adhesive labels to 

assist that office in processing your 

request. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the guidance. 

FOR FURTHER INFORMATION CONTACT: 

Michael E. Kashtock,Center for Food 

Safety and Applied Nutrition (HFS– 

317), Food and Drug Administration, 

5100 Paint Branch Pkwy., College Park, 

MD 20740, 301–436–2022. 

SUPPLEMENTARY INFORMATION: 

I. Background 

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 PeanutDerived Product as an Ingredient.’’ This 

guidance is intended to clarify for 

manufacturers who produce foods 

containing a peanut-derived product as 

an ingredient that there is a risk that 

Salmonella species (spp.) may be 

present in the incoming peanut-derived 

product, and to recommend measures to 

address that risk. Peanut-derived 

products include peanuts, peanut 

butter, peanut paste, peanut meal, and 

peanut granules. 

In the recent past, products made 

from peanuts have been associated with 

two large, multi-state Salmonella 

outbreaks. The first of these, an outbreak 

of Salmonella Tennessee in 2007 linked 

to peanut butter, resulted in more than 

600 illnesses in 47 states (Ref. 1). More 

recently, peanut butter and peanut paste 

have been confirmed as the source of a 

large multi-state outbreak caused by 

Salmonella Typhimurium (Ref. 2). 

Peanut-derived products that have been 

recalled have been used as ingredients 

in other products such as cookies, 

crackers, cereal, candy, and ice cream. 

This had led to additional recalls. 

FDA is issuing this guidance as a level 

1 guidance consistent with FDA’s good 

guidance practices regulation § 10.115 

(21 CFR 10.115). Consistent with FDA’s 

good guidance practices regulation, the 

agency will accept comment, but is 

implementing the guidance document 

immediately in accordance with 

§ 10.115(g)(2) because the agency has 

determined that prior public 

participation is not feasible or 

appropriate in light of the need to 

respond expeditiously to the current 

circumstances. The guidance represents 

the agency’s current thinking on 

measures to address the risk for 

contamination by Salmonella spp. in 

foods containing a peanut-derived 

product as an ingredient. It does not 

create or confer any rights for or on any 

person and does not operate to bind 

FDA or the public. An alternate 

approach may be used if such approach 

satisfies the requirements of the 

applicable statutes and regulations. 

II. Comments 

Interested persons may submit to the 

Division of Dockets Management (see 

ADDRESSES) written or electronic 

comments regarding this document. 

Submit a single copy of electronic 

comments or two paper copies of any 

mailed comments, except that 

individuals may submit one paper copy. 

Comments are to be identified 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.cfsan.fda.gov/guidance.html. 

IV. References 

The following references have been 

placed on display in the Division of 

Dockets Management (see ADDRESSES) 

and may be seen by interested persons 

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

through Friday. 

1. FDA, FDA Warns Consumers Not to 

Eat Certain Jars of Peter Pan Peanut 

Butter and Great Value Peanut Butter; 

Product May be Contaminated With 

Salmonella, FDA News, P07–21, 

available at http://www.fda.gov/bbs/ 

topics/NEWS/2007/NEW01563.html, 

February 14, 2007. 

2. FDA, Recall of Products Containing 

Peanut Butter; Salmonella 

Typhimurium, available at http:// 

www.fda.gov/oc/opacom/hottopics/ 

salmonellatyph.html, updated February 

4, 2009. 

Dated: March 9, 2009. 

Jeffrey Shuren, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E9–5367 Filed 3–9–09; 4:15 pm] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

Agency Information Collection 

Activities: Submission for OMB 

Review; Comment Request 

Periodically, the Health Resources 

and Services Administration (HRSA) 

publishes abstracts of information 

collection requests under review by the 

Office of Management and Budget 

(OMB), in compliance with the 

Paperwork Reduction Act of 1995 (44 

U.S.C. Chapter 35). To request a copy of 

the clearance requests submitted to 

OMB for review, e-mail 

paperwork@hrsa.gov or call the HRSA 

Reports Clearance Office on (301) 443– 

1129. 

The following request has been 

submitted to the Office of Management 

and Budget for review under the 

Paperwork Reduction Act of 1995: 

Proposed Project: Patient Navigator 

Outreach and Chronic Disease 

Prevention Demonstration Program 

Patient Data Collection Form—[New] 

The purpose of the Patient Navigator 

Outreach and Chronic Disease 

Prevention (PN) Demonstration Program 

is to promote model ‘‘patient navigator’’ 

programs to improve health care 

outcomes for individuals with cancer 

and/or other chronic diseases, with a 

specific emphasis on health disparity 

populations. This program aims to 

coordinate comprehensive health 

services for patients in need of chronic 

disease care and management through 

enhanced chronic disease management 

provided by patient navigators. 

In order to describe successful PN 

program models and make 

recommendations on the ability of such 

programs to improve patient outcomes, 

data is needed at the individual patient, 

patient navigator, and PN program 

levels. This information includes: 

fi Sociodemographics of patients 

(e.g., insurance status, income, 

education level, gender, age, race and 

ethnicity, primary language, number of 

family dependents) served; 

fi Patient access barriers to standard 

chronic disease care (e.g., access to 

pharmaceuticals, distance of patient’s 

home from health care facilities utilized, 

primary mode of transportation to 

health care facilities utilized, cultural 

and linguistic barriers as well as literacy 

levels); 

fi Health care service utilization 

(e.g., screening rates, compliance rate 

for appointments and follow-up exams, 


rwilkins on PROD1PC63 with NOTICES