Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices 31587 

Cosmetic Act (the act) (21 U.S.C. 

360e(d)(4) and (e)(2)), notification of an 

order approving, denying, or 

withdrawing approval of a PMA will 

continue to include a notice of 

opportunity to request review of the 

order under section 515(g) of the act. 

The 30-day period for requesting 

reconsideration of an FDA action under 

§ 10.33(b) (21 CFR 10.33(b)) for notices 

announcing approval of a PMA begins 

on the day the notice is placed on the 

Internet. Section 10.33(b) provides that 

FDA may, for good cause, extend this 

30-day period. Reconsideration of a 

denial or withdrawal of approval of a 

PMA may be sought only by the 

applicant; in these cases, the 30-day 

period will begin when the applicant is 

notified by FDA in writing of its 

decision. 

The regulations provide that FDA 

publish a quarterly list of available 

safety and effectiveness summaries of 

PMA approvals and denials that were 

announced during that quarter. The 

following is a list of approved PMAs for 

which summaries of safety and 

effectiveness were placed on the 

Internet from January 1, 2007, through 

March 31, 2007. There were no denial 

actions during this period. The list 

provides the manufacturer’s name, the 

product’s generic name or the trade 

name, and the approval date. 

TABLE 1.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM JANUARY 1, 

2007, THROUGH MARCH 31, 2007 

PMA No./Docket No. Applicant Trade Name Approval Date 

P040051/2007M–0109 Stelkast Co. STELKAST SURPASS ACETABULAR SYSTEM May 12, 2006 

P050037/2007M–0006 Bioform Medical, Inc. RADIESSE 1.3 CC AND 0.3 CC December 22, 2006 

P050052/2007M–0007 Bioform Medical, Inc. RADIESSE 1.3 CC AND 0.3 CC December 22, 2006 

P050018/2007M–0032 Angioscore, Inc. ANGIOSCULPT SCORING BALLOON CATHETER January 8, 2007 

P060001/2007M–0049 EV3, Inc. PROTEGE GPS AND PROTEGE RX CAROTID STENT 

SYSTEMS 

January 24, 2007 

H060004/2007M–0038 Fujirebio Diagnostics, 

Inc. 

FUJIREBIO MESOMARK ASSAY January 24, 2007 

P050007(S1)/2007M–0058 Abbott Vascular Devices STARCLOSE VASCULAR CLOSURE SYSTEM February 2, 2007 

P050013/2007M–0086 Tissue Seal, LLC. HISTOACRYL & HISTOACRYL BLUE TOPICAL SKIN ADHESIVE February 16, 2007 

P980022(S15)/2007M–0107 Medtronic Minimed GUARDIAN RT & PARADIGM REAL–TIME CONTIUOUS 

GLUCOSE MONITORING SYSTEMS 

March 8, 2007 

P050053/2007M–0084 Medtronic Sofamor 

Danek USA, Inc. 

INFUSE BONE GRAFT March 9, 2007 

P060019/2007M–0108 Irvine Biomedical, Inc. IBI THERAPY COOL PATH ABLATION CATHETER & IBI–

1500T9 RF ABLATION GENERATOR 

March 16, 2007 

II. Electronic Access 

Persons with access to the Internet 

may obtain the documents at http:// 

www.fda.gov/cdrh/pmapage.html. 

Dated: May 24, 2007. 

Linda S. Kahan, 

Deputy Director, Center for Devices and 

Radiological Health. 

[FR Doc. E7–11002 Filed 6–6–07; 8:45 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007N–0208] 

Science Board to the Food and Drug 

Administration; Amendment of Notice 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

The Food and Drug Administration 

(FDA) is announcing an amendment to 

the notice of meeting of the Science 

Board to the Food and Drug 

Administration (Science Board). This 

meeting was originally announced in 

the Federal Register of May 21, 2007 (72 

FR 28499). The amendment is being 

made to reflect a change in the Agenda 

and Procedure portions of the 

document. There are no other changes. 

FOR FURTHER INFORMATION CONTACT: 

Carlos Pen ̃ a, Office of the 

Commissioner, Food and Drug 

Administration (HF–33), 5600 Fishers 

Lane, Rockville, Maryland, 20857, 301–

827–6687, carlos.pen ̃ a@fda.hhs.gov, or 

FDA Advisory Committee Information 

Line, 1–800–741–8138 (301–443–0572 

in the Washington, DC area), code 

3014512603. Please call the Information 

Line for up-to-date information on this 

meeting. 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of May 21, 2007, FDA 

announced that a meeting of the Science 

Board would be held on June 14, 2007. 

On page 28499, in the second and third 

columns, the Agenda and Procedure 

portions of document are amended to 

read as follows: 

Agenda: The Science Board will hear 

about and discuss the agency’s 

bioinformatics initiative and fellowship 

program. The Science Board will hear 

about and review the scientific validity 

of the agency’s ‘‘Interim Melamine and 

Analogues Safety/Risk Assessment’’

(http://www.cfsan.fda.gov/~lrd/ 

fr070530.html, Docket No. 2007N–

0208). The Science Board will then 

continue its discussion of the review of 

both the agency’s science programs and 

the National Antimicrobial Resistance 

Monitoring System (NARMS) Program, 

from the March 31, 2006, Science Board 

meeting. Discussions will first include a 


rwilkins on PROD1PC63 with NOTICES
31588 Federal Register / Vol. 72, No. 109 / Thursday, June 7, 2007 / Notices 

subcommittee update to the Science 

Board on the progress of the review of 

the agency’s science programs. The 

Science Board will then hear about and 

discuss the subcommittee review of the 

NARMS Program including the public 

meeting regarding the NARMS Program 

on April 10, 2007, and subsequent 

deliberations. 

Procedure: Interested persons may 

present data, information, or views, 

orally or in writing, on issues pending 

before the committee. We are extending 

the written submission deadline based 

upon the amended Federal Register 

notice. Written submissions may be 

made to the contact person on or before 

June 9, 2007. Two oral presentations 

from the public will be scheduled 

between approximately 10:45 a.m. and 

11:45 p.m., and 3:15 p.m. and 4:15 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 June 9, 

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 sessions. The contact person 

will notify interested persons regarding 

their request to speak by June 9, 2007. 

This notice is issued under the 

Federal Advisory Committee Act (5 

U.S.C. app.2) and 21 CFR part 14, 

relating to the advisory committees. 

Dated: June 1, 2007. 

Randall W. Lutter, 

Associate Commissioner for Policy and 

Planning. 

[FR Doc. 07–2829 Filed 6–4–07; 11:10 am] 

BILLING CODE 4160–01–S 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Food and Drug Administration 

[Docket No. 2007E–0010] 

Determination of Regulatory Review 

Period for Purposes of Patent 

Extension; CHANTIX 

AGENCY: Food and Drug Administration, 

HHS. 

ACTION: Notice. 

SUMMARY: The Food and Drug 

Administration (FDA) has determined 

the regulatory review period for 

CHANTIX 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 CHANTIX 

(varenicline tartrate). CHANTIX is 

indicated as an aid to smoking cessation 

treatment. Subsequent to this approval, 

the Patent and Trademark Office 

received a patent term restoration 

application for CHANTIX (U.S. Patent 

No. 6,410,550) 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 January 26, 

2007, FDA advised the Patent and 

Trademark Office that this human drug 

product had undergone a regulatory 

review period and that the approval of 

CHANTIX 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 

CHANTIX is 2,401 days. Of this time, 

2,219 days occurred during the testing 

phase of the regulatory review period, 

while 182 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: October 15, 

1999. The applicant claims September 

15, 1999, as the date the investigational 

new drug application (IND) became 

effective. However, FDA records 

indicate that the IND effective date was 

October 15, 1999, which was 30 days 

after FDA receipt of the IND. 

2. The date the application was 

initially submitted with respect to the 

human drug product under section 

505(b) of the act: November 10, 2005. 

FDA has verified the applicant’s claim 

that the new drug application (NDA) for 

CHANTIX (NDA 21–928) was initially 

submitted on November 10, 2005. 

3. The date the application was 

approved: May 10, 2006. FDA has 

verified the applicant’s claim that NDA 

21–928 was approved on May 10, 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 545 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 August 6, 2007. 

Furthermore, any interested person may 

petition FDA for a determination 

regarding whether the applicant for 

extension acted with due diligence 


rwilkins on PROD1PC63 with NOTICES