Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices 14281 

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 

A180 is 5,365 days. Of this time, 5,314 

days occurred during the testing phase 

of the regulatory review period, while 

51 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 involving this animal 

drug product became effective: January 

14, 1988. The applicant claims January 

20, 1988, as the date the investigational 

new animal drug application (INAD) 

became effective. However, FDA records 

indicate that the date of FDA’s letter 

assigning a number to the INAD was 

January 14, 1988, which is considered to 

be the effective date for the INAD. 

2. The date the application was 

initially submitted with respect to the 

animal drug product under section 

512(b) of the Federal Food, Drug, and 

Cosmetic Act: August 1, 2002. FDA has 

verified the applicant’s claim that the 

new animal drug Application (NADA) 

for A180 (NADA 141–207) was initially 

submitted on August 1, 2002. 

3. The date the application was 

approved: September 20, 2002. The 

applicant claims September 24, 2002, as 

the date NADA 141–207 was approved. 

However, FDA records indicate that the 

date of approval was September 20, 

2002. 

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 1,826 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 24, 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 are to 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. E7–5504 Filed 3–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0090] 

Endocrinologic and Metabolic Drugs 

Advisory Committee; Notice of Meeting 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

This notice announces a forthcoming 

meeting of a public advisory committee 

of the Food and Drug Administration 

(FDA). The meeting will be open to the 

public. 

Name of Committee: Endocrinologic 

and Metabolic Drugs Advisory 

Committee. 

General Function of the Committee: 

To provide advice and 

recommendations to the agency on 

FDA’s regulatory issues. 

Date and Time: The meeting will be 

held on June 13, 2007, from 8 a.m. to 5 

p.m. 

Addresses: Electronic comments 

should be submitted to http:// 

www.fda.gov/dockets/ecomments. 

Select ‘‘2007N–0090’’ and follow the 

prompts to submit your statement. 

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, by close of 

business on May 30, 2007. All 

comments will be posted without 

change, including any personal 

information provided. Comments 

received on or before May 30, 2007, will 

be provided to the committee before or 

at the meeting. 

Location: Hilton Silver Spring, 8727 

Colesville Rd., Silver Spring, MD. The 

hotel telephone number is 301–589–

5200. 

Contact Person: Cathy A. Groupe, 

Center for Drug Evaluation and Research 

(HFD–21), Food and Drug 

Administration, 5600 Fishers Lane (for 

express delivery, 5630 Fishers Lane, rm. 

1093), Rockville, MD 20857, 301–827–

7001, FAX: 301–827–6776, e-mail: 

Cathy.Groupe@fda.hhs.gov, or FDA 

Advisory Committee Information Line, 

1–800–741–8138 (301–443–0572 in the 

Washington, DC area), code 

3014512536. Please call the Information 

Line for up-to-date information on this 

meeting. 

Agenda: The committee will discuss 

the efficacy and safety of new drug 

application (NDA) 21–888, proposed 

tradename Zimulti (rimonabant), 20 

milligrams tablets, Sanofi-Aventis, as an 

adjunct to diet and exercise for obesity 

management in patients with a body 

mass index equal to or greater than 30 

kilograms (kg) per square meter, or a 

body mass index equal to or greater than 

27 kg per square meter if accompanied 

by at least one cardiovascular risk 

factor. 

FDA intends to make background 

material available to the public no later 

than 1 business day before the meeting. 

If FDA is unable to post background 

material on its Web site prior to the 

meeting, the background material will 

be made publicly available at the 

location of the advisory committee 

meeting, and the background material 

will be posted on FDA’s Web site after 

the meeting. Background material is 

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

dockets/ac/acmenu.htm, click on the 

year 2007 and scroll down to the 

appropriate advisory committee link. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. Written 

submissions may be made to the contact 

person on or before May 30, 2007. Oral 

presentations from the public will be 

scheduled between approximately 1 

p.m. and 2 p.m. Those desiring to make 

formal oral presentations should notify 

the contact person and submit a brief 

statement of the general nature of the 

evidence or arguments they wish to 

present, the names and addresses of 

proposed participants, and an 

indication of the approximate time 

requested to make their presentation on 

or before May 22, 2007. Time allotted 

for each presentation may be limited. If 

the number of registrants requesting to 

speak is greater than can be reasonably 

accommodated during the scheduled 

open public hearing session, FDA may 

conduct a lottery to determine the 

speakers for the scheduled open public 

hearing session. The contact person will 

notify interested persons regarding their 

request to speak on or before May 21, 

2007. 


sroberts on PROD1PC70 with NOTICES
14282 Federal Register / Vol. 72, No. 58 / Tuesday, March 27, 2007 / Notices 

Persons attending FDA’s advisory 

committee meetings are advised that the 

agency is not responsible for providing 

access to electrical outlets. 

FDA welcomes the attendance of the 

public at its advisory committee 

meetings and will make every effort to 

accommodate persons with physical 

disabilities or special needs. If you 

require special accommodations due to 

a disability, please contact Cathy 

Groupe at least 7 days in advance of the 

meeting. 

Notice of this meeting is given under 

the Federal Advisory Committee Act (5 

U.S.C. app. 2). 

Dated: March 20, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. E7–5506 Filed 3–26–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007D–0083] 

Draft Guidance for Industry and Food 

and Drug Administration Staff; 

Modifications to Devices Subject to 

Premarket Approval—The Premarket 

Approval Supplement Decision-Making 

Process; Availability 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of the draft guidance 

entitled ‘‘Modifications to Devices 

Subject to Premarket Approval (PMA)—

The PMA Supplement Decision-Making 

Process.’’ This draft guidance is 

intended to help the regulated industry 

determine whether submitting a PMA 

supplement or other notification to FDA 

is required for class III devices subject 

to PMA. This draft guidance is not final 

nor is it in effect at this time. 

DATES: Submit written or electronic 

comments on this draft guidance by 

June 25, 2007. 

ADDRESSES: Submit written requests for 

single copies of the draft guidance 

document entitled ‘‘Modifications to 

Devices Subject to Premarket Approval 

(PMA)—The PMA Supplement 

Decision-Making Process’’ to the 

Division of Small Manufacturers, 

International, and Consumer Assistance 

(HFZ–220), Center for Devices and 

Radiological Health, Food and Drug 

Administration, 1350 Piccard Dr., 

Rockville, MD 20850. Send one selfaddressed adhesive label to assist that 

office in processing your request, or fax 

your request to 240–276–3151. See the 

SUPPLEMENTARY INFORMATION section for 

information on electronic access to the 

guidance. 

Submit written comments concerning 

this guidance 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. 

Identify comments with the docket 

number found in brackets in the 

heading of this document. 

FOR FURTHER INFORMATION CONTACT: 

For general questions: Thinh Nguyen, 

Center for Devices and Radiological 

Health (HFZ–402), Food and Drug 

Administration, 9200 Corporate 

Blvd., Rockville, MD 20850, 240–

276–4010. 

For questions about the 30-day notice 

program or regarding 

manufacturing site changes: Christy 

Foreman, Center for Devices and 

Radiological Health (HFZ–340), 

Food and Drug Administration, 

2094 Gaither Rd., Rockville, MD 

20850, 240–276–0120. 

For biologics issues: Leonard Wilson, 

Center for Biologics Evaluation and 

Research (HFM–25), Food and Drug 

Administration, 1401 Rockville 

Pike, Rockville, MD 20852, 301–

827–0373. 

SUPPLEMENTARY INFORMATION: 

I. Background 

This draft guidance is intended to 

help the regulated industry determine 

whether submitting a PMA supplement 

or other notification to FDA is required 

for class III devices subject to PMA. 

FDA developed this draft guidance to 

address modifications to device design, 

device labeling, and the device 

manufacturing process. This guidance 

also can be applied when a legally 

marketed class III device is the subject 

of a recall or field corrective action and 

the manufacturer needs to change the 

device to assure its safety and 

effectiveness. This draft guidance is 

intended to apply to the device portion 

of combination products such as drug/ 

device or biologic/device combinations. 

II. Significance of Guidance 

This draft guidance is being issued 

consistent with FDA’s good guidance 

practices regulation (21 CFR 10.115). 

The draft guidance, when finalized, will 

represent the agency’s current thinking 

on modifications to devices subject to 

PMA applications. It does not create or 

confer any rights for or on any person 

and does not operate to bind FDA or the 

public. An alternative approach may be 

used if such approach satisfies the 

requirements of the applicable statute 

and regulations. 

III. Electronic Access 

Persons interested in obtaining a copy 

of the draft guidance may do so by using 

the Internet. To receive ‘‘Modifications 

to Devices Subject to Premarket 

Approval (PMA)—The PMA 

Supplement Decision-Making Process,’’

you may either send an e-mail request 

to dsmica@fda.hhs.gov to receive an 

electronic copy of the document or send 

a fax request to 240–276–3151 to receive 

a hard copy. Please use the document 

number 1584 to identify the guidance 

you are requesting. 

CDRH maintains an entry on the 

Internet for easy access to information 

including text, graphics, and files that 

may be downloaded to a personal 

computer with Internet access. Updated 

on a regular basis, the CDRH home page 

includes device safety alerts, Federal 

Register reprints, information on 

premarket submissions (including lists 

of approved applications and 

manufacturers’ addresses), small 

manufacturer’s assistance, information 

on video conferencing and electronic 

submissions, Mammography Matters, 

and other device-oriented information. 

The CDRH Web site may be accessed at 

http://www.fda.gov/cdrh. A search 

capability for all CDRH guidance 

documents is available at http:// 

www.fda.gov/cdrh/guidance.html. 

Guidance documents are also available 

on the Division of Dockets Management 

Internet site at http://www.fda.gov/ 

ohrms/dockets. 

IV. Paperwork Reduction Act of 1995 

This draft guidance contains 

information collection provisions that 

are subject to review by the Office of 

Management and Budget (OMB) under 

the Paperwork Reduction Act of 1995 

(44 USC 3501–3520) (the PRA). The 

collections of information addressed in 

the draft guidance document have been 

approved by OMB in accordance with 

the PRA under the regulations 

governing PMA applications (21 CFR 

part 814, OMB control number 0910–

0231). 

V. 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 


sroberts on PROD1PC70 with NOTICES