Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Notices 12831

Act—Elimination of Market Entry

Barriers (GN Docket No. 96–113).

Number of petitions filed: 2.

Subject: Implementation of the NonAccounting Safeguards of Sections 271

and 272 of the Communications Act of

1934, as amended (CC Docket No. 96–

149).

Number of petitions filed: 8.

Subject: Implementation of the

Telecommunications Act of 1996;

Accounting Safeguards Under the

Telecommunications Act of 1996. (CC

Docket No. 96–150).

Number of petitions filed: 8.

Federal Communications Commission.

William F. Caton,

Acting Secretary.

[FR Doc. 97–6749 Filed 3–17–97; 8:45 am]

BILLING CODE 6712–01–M

FEDERAL RESERVE SYSTEM

Sunshine Act Meeting

TIME AND DATE: 12:00 noon, Monday,

March 24, 1997.

PLACE: Marriner S. Eccles Federal

Reserve Board Building, C Street

entrance between 20th and 2lst Streets,

N.W., Washington, D.C. 20551.

STATUS: Closed.

MATTERS TO BE CONSIDERED:

1. Personnel actions (appointments,

promotions, assignments,

reassignments, and salary actions)

involving individual Federal Reserve

System employees.

2. Any items carried forward from a

previously announced meeting.

CONTACT PERSON FOR MORE INFORMATION:

Mr. Joseph R. Coyne, Assistant to the

Board; (202) 452–3204. You may call

(202) 452–3207, beginning at

approximately 5 p.m. two business days

before this meeting, for a recorded

announcement of bank and bank

holding company applications

scheduled for the meeting.

Dated: March 14, 1997.

Jennifer J. Johnson,

Deputy Secretary of the Board.

[FR Doc. 97–6957 Filed 3–14–97; 2:44 pm]

BILLING CODE 6210–01–P

GENERAL SERVICES

ADMINISTRATION

Availability of Final Environmental

Impact Statement/Environmental

Impact; Report for Proposed San

Francisco Federal Building, San

Francisco, CA

AGENCY: Public Buildings Service,

United States General Services

Administration.

ACTION: Notice.

SUMMARY: The United States General

Services Administration (GSA) hereby

gives notice that a joint Final

Environmental Impact Statement/

Environmental Impact Report (EIS/EIR)

has been prepared and filed with the

United States Environmental Protection

Agency (EPA) for the proposed

construction of a new Federal Building

within the City of San Francisco,

California, in accordance with the

Council of Environmental Quality

regulations and the procedural

provisions of the National

Environmental Policy Act (NEPA). The

proposed project involves the

construction of a new Federal Building

with 161 approximately 475,000

occupiable square feet of space (675,000

gross square feet) and onsite parking

spaces. The purpose of this project is (1)

to consolidate federal agencies housed

in multiple locations in order to

increase efficiency and to reduce the

amount of government leased space and

(2) to house law enforcement agencies

that are not suitable as lease tenants.

The preferred alternative for this project

is the site located at 7th and Mission

Streets.

DATES: Submit written comments on the

Final EIS/EIR to GSA on or before April

21, 1997.

ADDRESSES: Mail written comments and

requests for copies to Ms. Jane Woo,

U.S. General Services Administration,

Portfolio Management Division (9PT),

450 Golden Gate Avenue, 3rd Floor, San

Francisco, California 94102.

FOR FURTHER INFORMATION CONTACT:

Ms. Jane Woo, (415) 522–3487.

(Authority: NEPA, the Environmental Quality

Improvement Act of 1970, as amended (42

U.S.C. 4371 et seq.), sec. 309 of the Clean Air

Act, as amended (42 U.S.C. 7609), and E.O.

11514 (Mar. 5, 1970, as amended by E.O.

11991, May 24, 1977)).

Dated: March 11, 1997.

Kenn N. Kojima,

Regional Administrator (9A).

[FR Doc. 97–6820 Filed 3–17–97; 8:45 am]

BILLING CODE 6820–23–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E–0504]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; BAYTRIL

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

BAYTRIL 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 Commissioner of

Patents and Trademarks, Department of

Commerce, for the extension of a patent

which claims that animal drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

SUPPLEMENTARY INFORMATION: The Drug

Price Competition and Patent Term

Restoration Act of 1984 (Pub. L. 98–417)

and the Generic Animal Drug and Patent

Term Restoration Act (Pub. L. 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
12832 Federal Register / Vol. 62, No. 52 / Tuesday, March 18, 1997 / Notices

regulatory review period may count

toward the actual amount of extension

that the Commissioner 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 BAYTRIL

(enrofloxacin). BAYTRIL is indicated

for chickens to control mortality

associated with Escherichia coli

susceptible to enrofloxacin, and for

turkeys to control mortality associated

with E. coli and Pasturella multocida

(fowl cholera) susceptible to

enrofloxacin. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for BAYTRIL (U.S. Patent

No. 4,670,444) from Bayer

Aktiengesellschaft and requested FDA’s

assistance in determining the patent’s

eligibility for patent term restoration. In

a letter dated January 21, 1997, FDA

advised the Patent and Trademark

Office that this animal drug product had

undergone a regulatory review period

and that the approval of BAYTRIL

represented the first commercial

marketing 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

BAYTRIL is 4,334 days. Of this time,

648 days occurred during the testing

phase of the regulatory review period,

while 3,686 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 became effective:

November 24, 1984. The applicant

claims November 20, 1984, as the date

the investigational new animal drug

application (INAD) became effective.

However, FDA records indicate that the

date of FDA’s official acknowledgment

letter assigning a number to the INAD

was November 24, 1984, which is

considered to be the effective date for

the INAD.

2. The date the application was

initially submitted with respect to the

human drug product under section

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

Cosmetic Act: September 2, 1986. The

applicant claims August 26, 1986, as the

date the new animal drug application

(NADA) for BAYTRIL (NADA 140–

828) was initially submitted. However,

a review of FDA records reveals that the

date of FDA’s official acknowledgment

letter assigning a number to the NADA

was September 2, 1986, which is

considered to be the initially submitted

date for the NADA.

3. The date the animal drug was

approved: October 4, 1996. FDA has

verified the applicant’s claim that

NADA 140–828 was approved on

October 4, 1996.

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 1,827 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before May 19, 1997, submit to the

Dockets Management Branch (address

above) written comments and ask for a

redetermination. Furthermore, any

interested person may petition FDA, on

or before September 15, 1997, for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. 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 Dockets Management

Branch (address above) in three copies

(except that individuals may submit

single copies) and identified with the

docket number found in brackets in the

heading of this document. Comments

and petitions may be seen in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

Dated: March 6, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–6719 Filed 3–17–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 97D–0024]

Medical Devices; Immunotoxicity

Testing Framework; Draft Guidance;

Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance entitled

‘‘Immunotoxicity Testing Framework.’’

This guidance will provide reviewers

and manufacturers with a coherent

strategy for assessing whether testing for

potential adverse effects involving

medical devices or constituent materials

and the immune system is needed. The

draft guidance will also aid in

developing a systematic approach to

such testing.

DATES: Written comments by June 16,

1997.

ADDRESSES: Submit written requests for

single copies of the draft guidance

entitled ‘‘Immunotoxicity Testing

Framework’’ to the Division of Small

Manufacturers Assistance, Center for

Devices and Radiological Health (HFZ–

220), Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–443–0806 (toll free outside

of MD 1–800–638–2041). Send two self

addressed adhesive labels to assist that

office in processing your requests. The

draft guidance is also available via the

World Wide Web at http://

www.fda.gov/cdrh/draftgui.html. A text

only version is also available from a

VT–100 compatible terminal via the

FDA bulletin board by dialing 800–

222–0185 (terminal settings are 8/1/N).

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 12420 Parklawn Dr.,

rm. 1–23, Rockville MD 20857. Requests

and comments should be identified with

the docket number found in brackets in

the heading of this document. A copy of

the draft guidance and received

comments are available for public

examination in the Dockets

Management Branch (address above)

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

through Friday.

FOR FURTHER INFORMATION CONTACT: John

J. Langone, Center for Devices and

Radiological Health (HFZ–113), Food

and Drug Administration, 12709

Twinbrook Pkwy., Rockville, MD 20852,

301–443–7132.

SUPPLEMENTARY INFORMATION:

I. Background

In May 1995, FDA adopted the

General Program Memorandum G95–1,

an FDA-modified version of

International Standard ISO–10993,

entitled ‘‘Biological Evaluation of

Medical Devices-Part 1: Evaluation and

Testing.’’ It was pointed out that in

addition to the general guidance for

toxicity testing contained in that

document, additional guidance might be

needed for evaluation of specific organ

or system toxicity. As a result, the Office

of Device Evaluation, Center for Devices

and Radiological Health, developed the