14820 Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Notices 

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 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 VAPRISOL 

(conivaptan hydrochloride). VAPRISOL 

is indicated for treatment of euvolemic 

hyponatremia in hospitalized patients. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

VAPRISOL (U.S. Patent No. 5,723,606) 

from Astellas Pharma, 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 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 

VAPRISOL 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 

VAPRISOL is 2,796 days. Of this time, 

2,096 days occurred during the testing 

phase of the regulatory review period, 

while 700 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: May 6, 1998. 

FDA has verified the applicant’s claim 

that the date the Investigational New 

Drug application became effective was 

on May 6, 1998. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: January 30, 2004. FDA 

has verified the applicant’s claim that 

the new drug application (NDA) for 

VAPRISOL (NDA 21–697) was initially 

submitted on January 30, 2004. 

3. The date the application was 

approved: December 29, 2005. FDA has 

verified the applicant’s claim that NDA 

21–697 was approved on December 29, 

2005. 

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 1,745 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 29, 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 

September 25, 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. E7–5737 Filed 3–28–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2003N–0312] 

Meeting to Present Work-in-Progress 

on a Method for Ranking Feed 

Contaminants According to the 

Relative Risks They Pose to Animal 

and Public Health; Part 2: Exposure 

Scoring for Feed Contaminants; Public 

Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice of public meeting; 

request for comments. 

The Food and Drug Administration 

(FDA) is announcing the following 

public meeting: ‘‘Meeting to Present 

Work-in-Progress on a Method for 

Ranking Feed Contaminants According 

to the Relative Risks They Pose to 

Animal and Public Health; Part 2: 

Exposure Scoring for Feed 

Contaminants.’’ The topic to be 

discussed will present work-in-progress 

on a method for ranking animal feed 

contaminants by their relative risks to 

animal and human health. The relative 

risk posed by feed contaminants to 

animal and human health consists of 

two components, namely, health 

consequence scoring and exposure 

scoring. At a meeting held in September 

2006, the agency presented its current 

thinking on health consequence scoring. 

At this public meeting, the agency will 

describe the methods it plans to use to 

develop animal and human exposure 

scoring for chemical, physical, and 

microbiological feed contaminants. At a 

subsequent public meeting, FDA will 

present information on its relative riskranking model and how the health 

consequence scoring and exposure 

scoring will be combined to determine 

the relative risks of contaminants in 

feed. 

Date and Time: The public meeting 

will be held on May 22, 2007, from 9 

a.m. to 4 p.m. 

Location: The public meeting will be 

held at the Holiday Inn, 2 Mongomery 

Village Ave., Gaithersburg, MD 20879. 

Contact: For general information: Zoe 

Gill, Center for Veterinary Medicine 

(HFV–226), Food and Drug 

Administration, 7519 Standish Pl., 


jlentini on PROD1PC65 with NOTICES
Federal Register / Vol. 72, No. 60 / Thursday, March 29, 2007 / Notices 14821 

Rockville, MD 20855, 240–453–6867, 

FAX: 240–453–6882, or e-mail: 

zoe.gill@fda.hhs.gov. 

For registration: Nanette Milton, 

Center for Veterinary Medicine 

(HFV–200), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–

6840, FAX: 240–453–6880, or email: nanette.milton@fda.hhs.gov. 

Registration: Send registration 

information (including name, title, firm 

name, address, telephone, and fax 

number) to the contact person (see 

Contact). To obtain the registration form 

via the Web site, go to http:// 

www.fda.gov/cvm/AFSS052007PM.htm. 

Due to limited meeting space, 

registration will be required. We 

strongly encourage early registration. 

If you need special accommodations 

due to a disability, please contact 

Nanette Milton (see Contact) no later 

than May 15, 2007. 

Comments: Written comments should 

be submitted to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Electronic 

comments may be submitted to the 

docket at the following Web site: http:// 

www.fda.gov/dockets/ecomments. 

Submit a single copy of electronic 

comments or two paper copies of any 

written 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. 

The docket will remain open for written 

or electronic comments through June 21, 

2007, 30 days following the meeting. 

SUPPLEMENTARY INFORMATION: 

I. Background 

The Animal Feed Safety System 

(AFSS) is FDA’s program for animal 

feed aimed at protecting human and 

animal health by ensuring animal feed 

is safe. It covers the entire spectrum of 

agency activities from preapproval of 

food additives and drugs for use in feed, 

to establishing limits for feed 

contaminants, providing education and 

training, conducting inspections, and 

taking enforcement actions for ensuring 

compliance with agency regulations. 

The AFSS includes oversight of all feed 

ingredients and mixed feed at all stages 

of manufacture, production, distribution 

and use, whether at commercial or noncommercial establishments. 

During the past several years, FDA 

has been considering changes that need 

to be made to the AFSS to ensure that 

it is comprehensive, preventive and 

risk-based. As part of this effort, the 

agency is developing a model for 

ranking the relative risks to human and 

animal health from contaminants in 

animal feed. An effective model will 

permit the agency to systematically 

distinguish among feed hazards based 

on the relative risks they pose to 

animals or humans. Such a model will 

consider the risks of hazards present in 

incoming materials or feed ingredients 

and will also consider how activities at 

feed manufacturing, storage, 

distribution, and transportation 

facilities may modify such risks. For the 

purpose of the AFSS, FDA defines a 

feed hazard as a biological, chemical, or 

physical agent in, or condition of, feed 

with the potential to cause an adverse 

health effect in animals or humans. 

Previously, FDA held three public 

meetings to discuss the AFSS. The first 

two meetings were held on September 

23 and 24, 2003, in Herndon, VA and 

on April 5 and 6, 2005, in Omaha, NE. 

These public meetings included active 

participation by consumers, animal feed 

processors, animal producers, and State 

and other Federal government agencies. 

Following the meetings, we placed a 

number of documents in FDA’s docket 

for the AFSS project (see docket number 

found in brackets in the heading of this 

document). These documents included 

transcripts of the meetings, summaries 

of break-out discussion groups, 

presentations of invited speakers and 

meeting summaries. We also placed in 

FDA’s docket a number of other 

documents relating to the AFSS, 

including a framework for the AFSS that 

lists the principal components of the 

AFSS and the gaps the agency has 

identified which are being addressed by 

the agency team working on the AFSS 

project. These documents provided 

general background material on the 

AFSS for the third public meeting that 

was held on September 12, 2006, in 

Rockville, MD. 

The September 2006 meeting was the 

first of several planned by FDA to 

discuss aspects of the AFSS relative risk 

ranking model during the model’s 

development by the agency. In this 

model, information about the health 

consequences posed by the hazardous 

contaminants will be combined with 

information about exposures to the 

contaminants in animal feed. At the 

September 2006 meeting, the agency 

presented its current thinking on the 

development of a health consequences 

scoring system to represent the animal 

and human health consequences 

associated with the feed contaminants. 

The meeting also afforded the 

opportunity for attendees and agency 

presenters to have an open discussion 

concerning the health consequences 

approach being considered by the 

agency. The presentations and the 

transcript of the meeting have been 

added to the AFSS docket. 

At the May 22, 2007, meeting, which 

will be held in Gaithersburg, MD, FDA 

will continue its discussions on the 

development of the AFSS relative risk 

ranking model by focusing on the 

exposure component of the model. The 

exposure scoring system under 

development intends to address the 

presence of contaminants in source 

materials for feed ingredients and those 

factors in manufacturing and/or 

processing that may affect the levels of 

contaminants in final feed formulations. 

At the May 2007 meeting, the agency 

will use the production of swine feed as 

an example exposure scenario to 

illustrate its approach to exposure 

assessment. 

At one or more subsequent meetings, 

the agency will present information 

about how health consequences and 

exposure are combined to determine the 

relative risks of contaminants in animal 

feed and various aspects of the relative 

risk model developed by the agency. 

II. Meeting 

We are holding the public meeting in 

an effort to gather further information 

from you, our stakeholders, on changes 

to the AFSS that will help minimize 

risks to animal and human health 

associated with animal feed. Prior to the 

public meeting, FDA will place a 

document entitled ‘‘Exposure Scoring 

for Feed Contaminants—A Swine Feed 

Example’’ in the docket found in 

brackets in the heading of this notice. 

The document will summarize the 

agency’s methods for determining 

exposures to physical, chemical, and 

microbiological contaminants that may 

be present in swine feed. Details of 

these methods will be discussed at the 

meeting. A draft agenda for the meeting 

will also be placed in the docket prior 

to the meeting. 

Dated: March 20, 2007. 

Jeffrey Shuren, 

Assistant Commissioner for Policy. 

[FR Doc. E7–5820 Filed 2–28–07; 8:45 am] 

BILLING CODE 4160–01–S 


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