58446 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 

application to the Director of Patents 

and Trademarks, Department of 

Commerce, for the extension of a patent 

which claims that human biological 

product.

ADDRESSES: Submit written or electronic 

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:

Claudia V. Grillo, Office of Regulatory 

Policy (HFD–013), Food and Drug 

Administration, 5600 Fishers Lane, 

Rockville, MD 20857, 240–453–6699.

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 

biological products, the testing phase 

begins when the exemption to permit 

the clinical investigations of the 

biological becomes effective and runs 

until the approval phase begins. The 

approval phase starts with the initial 

submission of an application to market 

the human biological product and 

continues until FDA grants permission 

to market the biological 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 biological 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 biologic product AMEVIVE 

(alefacept). AMEVIVE is indicated for 

the treatment of adult patients with 

moderate to severe chronic plaque 

psoriasis who are candidates for 

systemic therapy or phototherapy. 

Subsequent to this approval, the Patent 

and Trademark Office received a patent 

term restoration application for 

AMEVIVE (U.S. Patent No. 5,547,853) 

from Biogen, 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 November 18, 2003, FDA 

advised the Patent and Trademark 

Office that this human biologic product 

had undergone a regulatory review 

period and that the approval of 

AMEVIVE 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 

AMEVIVE is 2,104 days. Of this time, 

1,618 days occurred during the testing 

phase of the regulatory review period, 

while 486 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 (21 U.S.C. 355(i)) 

became effective (21 U.S.C. 355(i)): 

April 29, 1997. FDA has verified the 

applicant’s claim that the date the 

investigational new drug application 

became effective was on April 29, 1997.

2. The date the application was 

initially submitted with respect to the 

human biological product under section 

351 of the Public Health Service Act (42 

U.S.C. 262): October 2, 2001. FDA has 

verified the applicant’s claim that the 

biological license application (BLA) for 

Amevive (BLA 12536) was initially 

submitted on October 2, 2001.

3. The date the application was 

approved: January 30, 2003. FDA has 

verified the applicant’s claim that BLA 

12536 was approved on January 30, 

2003.

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 1,259 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 

comments and ask for a redetermination 

by November 29, 2004. 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 March 29, 2005. 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: August 30, 2004.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug 

Evaluation and Research.

[FR Doc. 04–21874 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 2004M–0147, 2004M–0145, 

2004M–0207, 2004M–0253, 2004M–0165, 

2004M–0200, 2004M–0199, 2004M–0256, 

2004M–0248, 2004M–0249, 2004M–0250, 

2004M–0260, and 2004M–0259]

Medical Devices; Availability of Safety 

and Effectiveness Summaries for 

Premarket Approval Applications

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is publishing a 

list of premarket approval applications 

(PMAs) that have been approved. This 

list is intended to inform the public of 

the availability of safety and 

effectiveness summaries of approved 

PMAs through the Internet and the 

agency’s Division of Dockets 

Management.

ADDRESSES: Submit written requests for 

copies of summaries of safety and 

effectiveness to the Division of Dockets 

Management (HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Please cite 

the appropriate docket number as listed 

in table 1 of this document when 

submitting a written request. See the 

SUPPLEMENTARY INFORMATION section for 

electronic access to the summaries of 

safety and effectiveness.

FOR FURTHER INFORMATION CONTACT:

Thinh Nguyen, Center for Devices and 

Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 58447

Radiological Health (HFZ–402), Food 

and Drug Administration, 9200 

Corporate Blvd., Rockville, MD 20850, 

301–594–2186.

SUPPLEMENTARY INFORMATION:

I. Background

In the Federal Register of January 30, 

1998 (63 FR 4571), FDA published a 

final rule that revised 21 CFR 814.44(d) 

and 814.45(d) to discontinue individual 

publication of PMA approvals and 

denials in the Federal Register. Instead, 

the agency now posts this information 

on the Internet on FDA’s home page at 

http://www.fda.gov. FDA believes that 

this procedure expedites public 

notification of these actions because 

announcements can be placed on the 

Internet more quickly than they can be 

published in the Federal Register, and 

FDA believes that the Internet is 

accessible to more people than the 

Federal Register.

In accordance with section 515(d)(4) 

and (e)(2) of the Federal Food, Drug, and 

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 April 1, 2004, through 

June 30, 2004. 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 APRIL 1, 

2004 THROUGH JUNE 30, 2004.

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

P890064(S9)/2004M–0147 Digene Diagnostics, Inc. DIGENE HYBRID CAPTURE 2 (HC2) 

HIGH–RISK HPV DNA TEST

March 31, 2003

P020006/2004M–0145 Enteric Medical Technologies, 

Inc.

ENTERYX PROCEDURE KIT April 22, 2003

P970027/2004M–0207 Abbott Laboratories ABBOTT AXSYM ANTIBODY TO HCV February 5, 2004

P980007/2004M–0253 Abbott Laboratories AXSYM FREE PSA February 5, 2004

H020008/2004M–0165 Stryker Biotech OP–1 PUTTY April 7, 2004

P010014/2004M–0200 Biomet, Inc. OXFORD MENISCAL 

UNICOMPARTMENTAL KNEE SYSTEM

April 21, 2004

P030032/2004M–0199 Genzyme Biosurgery HYLAFORM (HYLAN B GEL) April 22, 2004

P030017/2004M–0256 Advanced Bionics Corp. Precision Spinal Cord Stimulation 

(SCS) System

April 27, 2004

P030023/2004M–0248 Ophtec USA, Inc. OCULAID/STABLEYES CAPULAR 

TENSION RINGS

April 27, 2004

P000054/2004M–0249 Wyeth Pharmaceuticals, Inc. INFUSE BONE GRAFT April 30, 2004

P030035/2004M–0250 St. Jude Medical ST. JUDE FRONTIER 

BIVENTRICULAR CARDIAC PACING SYSTEM

May 13, 2004

P010062/2004M–0260 Euclid Systems Corp. EUCLID SYSTEMS 

ORTHOKERATOLOGY 

(OPRIFOCOM A) CONTACT LENS 

FOR OVERNIGHT WEAR

June 7, 2004

P030045/2004M–0259 Ev3 Inc. INTRASTENT DOUBLESTRUT 

STENT

June 8, 2004

58448 Federal Register / Vol. 69, No. 189 / Thursday, September 30, 2004 / Notices 

II. Electronic Access

Persons with access to the Internet 

may obtain the documents at http://

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

Dated: September 23, 2004.

Linda S. Kahan,

Deputy Director, Center for Devices and 

Radiological Health.

[FR Doc. 04–21873 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0438]

Guidance for Industry: Use of Material 

from Bovine Spongiform 

Encephalopathy-Positive Cattle in 

Animal Feed; Availability

AGENCY: Food and Drug Administration, 

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug 

Administration (FDA) is announcing the 

availability of a guidance for industry 

(#174) entitled ‘‘Use of Material from 

BSE-Positive Cattle in Animal Feed.’’

This guidance document describes 

FDA’s current thinking regarding the 

use in all animal feed of all material 

from cattle that test positive for BSE 

(bovine spongiform encephalopathy).

DATES: Submit written or electronic 

comments on agency guidances at any 

time.

ADDRESSES: Submit written comments 

to the Division of Dockets Management 

(HFA–305), Food and Drug 

Administration, 5630 Fishers Lane, rm. 

1061, Rockville, MD 20852. Submit 

electronic comments on the guidance 

via the Internet at http://www.fda.gov/

dockets/ecomments. Comments should 

be identified with the full title of the 

guidance and the docket number found 

in brackets in the heading of this 

document. See the SUPPLEMENTARY

INFORMATION section for electronic 

access to the document.

Submit written requests for single 

copies of the guidance to the 

Communications Staff (HFV–12), Center 

for Veterinary Medicine, Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855. Send one selfaddressed adhesive label to assist that 

office in processing your requests.

FOR FURTHER INFORMATION CONTACT: Burt 

Pritchett, Center for Veterinary 

Medicine (HFV–222), Food and Drug 

Administration, 7519 Standish Pl., 

Rockville, MD 20855, 240–453–6860, email: burt.pritchett@fda.gov.

SUPPLEMENTARY INFORMATION:

I. Background

BSE belongs to a family of animal and 

human diseases called transmissible 

spongiform encephalopathies (TSEs). 

These include BSE or ‘‘mad cow’’

disease in cattle; scrapie in sheep and 

goats; and classical and variant 

Creutzfeldt-Jakob diseases (CJD and 

vCJD) in humans. There is no known 

treatment for these diseases, and there is 

no vaccine to prevent them. In addition, 

although validated postmortem 

diagnostic tests are available, there are 

no validated diagnostic tests for BSE or 

other TSEs that can be used to test for 

the disease in live animals or humans.

Under FDA’s BSE feed regulation (21 

CFR 589.2000) any protein-containing 

portion of mammalian animals is 

prohibited for use in feed for ruminant 

animals with the exception of certain 

products. FDA took this action to 

minimize the potential for any 

undetected BSE infectivity in animal 

feed to spread to ruminants via their 

feed. This guidance document describes 

FDA’s recommendations regarding the 

use in all animal feed of all material 

from cattle that test positive for BSE.

II. Paperwork Reduction Act of 1995

FDA concludes that this guidance 

contains no collections of information. 

Therefore, clearance by the Office of 

Management and Budget under the 

Paperwork Reduction Act of 1995 is not 

required.

III. Significance of Guidance

This level 1 guidance is being issued 

consistent with FDA’s good guidance 

practices (GGPs) regulation in 

§ 10.115(21 CFR 10.115). It is being 

implemented immediately without prior 

public comment, under § 10.115(g)(2), 

because FDA believes that, in light of 

the increased BSE testing activities by 

the U.S. Department of Agriculture, it is 

of public health importance to clarify 

that cattle that test positive for BSE are 

adulterated and are not to be used in 

any animal feed.

This guidance represents the agency’s 

current thinking on the topic. 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 method 

may be used as long as it satisfies the 

requirements of applicable statutes and 

regulations.

IV. Comments

As with all of FDA’s guidance, the 

public is encouraged to submit written 

or electronic comments with new data 

or other new information pertinent to 

this guidance. FDA periodically will 

review the comments in the docket and, 

where appropriate, will amend the 

guidance. The public will be notified of 

any such amendments through a 

document in the Federal Register.

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.

V. Electronic Access

Copies of this guidance document 

may be obtained from the Center for 

Veterinary Medicine home page (http:/

/www.fda.gov/cvm) and from the 

Division of Dockets Management Web 

site (http://www.fda.gov/ohrms/dockets/

default.htm).

Dated: September 24, 2004.

Jeffrey Shuren,

Assistant Commissioner for Policy.

[FR Doc. 04–22014 Filed 9–29–04; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004D–0385]

Guidance for Industry and Food and 

Drug Administration Staff; Class II 

Special Controls Guidance Document: 

Hepatitis A Serological Assays for the 

Clinical Laboratory Diagnosis of 

Hepatitis A Virus; 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 ‘‘Class II Special Controls 

Guidance Document: Hepatitis A 

Serological Assays for the Clinical 

Laboratory Diagnosis of Hepatitis A 

Virus.’’ This draft guidance document 

describes a means by which in vitro 

diagnostic devices for the laboratory 

diagnosis of Hepatitis A Virus may 

comply with the requirement of special 

controls for class II devices. Elsewhere 

in this issue of the Federal Register, 

FDA is publishing a proposed rule to 

reclassify these device types from class 

III into class II (special controls).