Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices 24389

* All States and Territories except

Alabama, Alaska, Colorado,

Connecticut, Hawaii, Idaho, Kansas,

Louisiana, Massachusetts, Minnesota,

Montana, Nebraska, New Jersey, Ohio,

Oklahoma, Oregon, Pennsylvania, South

Dakota, Tennessee, Vermont, Virginia,

Washington, American Samoa and

Palau have elected to participate in the

Executive Order process and have

established Single Points of Contact

(SPOCs). Applicants from these twentyfour jurisdictions need take no action

regarding E.O. 12372. Applicants for

projects to be administered by

Federally-recognized Indian Tribes are

also exempt from the requirements of

E.O. 12372. Otherwise, applicants

should contact their SPOCs as soon as

possible to alert them of the prospective

applications and receive any necessary

instructions. Applicants must submit

any required material to the SPOCs as

soon as possible so that the program

office can obtain and review SPOC

comments as part of the award process.

It is imperative that the applicant

submit all required materials, if any, to

the SPOC and indicate the date of this

submittal (or the date of contact if no

submittal is required) on the Standard

Form 424, item 16a.

Under 45 CFR 100.8(a)(2), a SPOC has

60 days from the application deadline to

comment on proposed new or

competing continuation awards.

SPOCs are encouraged to eliminate

the submission of routine endorsements

as official recommendations.

Additionally, SPOCs are requested to

clearly differentiate between mere

advisory comments and those official

State process recommendations which

may trigger the accommodation or

explain rule.

When comments are submitted

directly to ACF, they should be

addressed to: Marguerite Pridgen, Office

of Grants Management, 330 C Street,

SW., Washington, DC 20447, Attn: Child

Care Policy Research Discretionary

Grants. A list of the Single Points of

Contact (SPOCs) for each State and

Territory can be found on the following

web site: http://www.whitehouse.gov/

omb/grants/spoc.html.

The Catalog of Federal Domestic

Assistance number for all priority areas is

93.647.

Dated: May 8, 2001.

James A. Harrell,

Acting Commissioner, Administration on

Children, Youth and Families.

[FR Doc. 01–12010 Filed 5–11–01; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E–0476]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; Infergen

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for Infergen

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 human biological product.

ADDRESSES: Submit written comments

and petitions to the Dockets

Management Branch (HFA–305), Food

and Drug Administration, 5630 Fishers

Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:

Claudia Grillo, Regulatory Policy Staff

(HFD–007),Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–594–5645.

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

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

a human biological 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 biological product Infergen

(interferon alfacon–1 or consensus

interferon). Infergen is indicated for the

treatment of chronic hepatitis C virus

(HCV) infection in patients 18 years of

age or older with compensated liver

disease who have anti-HCV serum antibodies and/or presence of HCV RNA

(ribonucleic acid). Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for Infergen (U.S. Patent No.

4,695,623) from Amgen, 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

9, 1998, FDA advised the Patent and

Trademark Office that this human

biological product had undergone a

regulatory review period and that the

approval of Infergen represented the

first permitted commercial marketing or

use of the product. Later, 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

Infergen is 4,394 days. Of this time,

3,849 days occurred during the testing

phase of the regulatory review period,

while 545 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: September 27, 1985.

FDA has verified the applicant’s claim

that the date the investigational new

drug application became effective was

on September 27, 1985.

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): April 10, 1996. FDA has

verified the applicant’s claim that the

product license application (PLA) for

Infergen (PLA 96–0486) was initially

submitted on April 10, 1996.

3. The date the application was

approved: October 6, 1997. FDA has

verified the applicant’s claim that PLA

96–0486 was approved on October 6,

1997.

24390 Federal Register / Vol. 66, No. 93 / Monday, May 14, 2001 / Notices

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 Dockets Management

Branch (address above) written

comments and ask for a redetermination

by July 13, 2001. 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 November 13, 2001. 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. Three copies of any 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

Dockets Management Branch between 9

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

Friday.

Dated: February 26, 2001.

Jane A. Axelrad,

Associate Director for Policy, Center for Drug

Evaluation and Research.

[FR Doc. 01–12025 Filed 5–11–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D–3082]

International Conference on

Harmonisation; Choice of Control

Group and Related Issues in Clinical

Trials; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a guidance entitled ‘‘E10

Choice of Control Group and Related

Issues in Clinical Trials.’’ The guidance

was prepared under the auspices of the

International Conference on

Harmonisation of Technical

Requirements for Registration of

Pharmaceuticals for Human Use (ICH).

The guidance sets forth general

principles that are relevant to all

controlled trials and are especially

pertinent to the major clinical trials

intended to demonstrate drug (including

biological drug) efficacy. The guidance

describes the principal types of control

groups and discusses their

appropriateness in particular situations.

The guidance is intended to assist

sponsors and investigators in the choice

of control groups for clinical trials.

DATES: This guidance is effective May

14, 2001. Submit written comments on

agency guidances at any time.

ADDRESSES: Submit written requests for

single copies of the guidance to the Drug

Information Branch (HFD–210), Center

for Drug Evaluation and Research, Food

and Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, or the Office

of Communication, Training and

Manufacturers Assistance (HFM–40),

Center for Biologics Evaluation and

Research (CBER), 1401 Rockville Pike,

Rockville, MD 20852–1448, 301–827–

3844, FAX: 888–CBERFAX. Send two

self-addressed adhesive labels to assist

the office in processing your requests.

Submit written comments on the

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the guidance.

Requests and comments should be

identified with the docket number

found in brackets in the heading of this

document.

FOR FURTHER INFORMATION CONTACT:

Regarding the guidance: Robert

Temple, Center for Drug Evaluation

and Research (HFD–4), Food and

Drug Administration, 5600 Fishers

Lane, Rockville, MD 20857, 301–

594–6758.

Regarding the ICH: Janet J. Showalter,

Office of International Affairs

(HFG–1), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–

0864.

SUPPLEMENTARY INFORMATION:

I. Background

In recent years, many important

initiatives have been undertaken by

regulatory authorities and industry

associations to promote international

harmonization of regulatory

requirements. FDA has participated in

many meetings designed to enhance

harmonization and is committed to

seeking scientifically based harmonized

technical procedures for pharmaceutical

development. One of the goals of

harmonization is to identify and then

reduce differences in technical

requirements for drug development

among regulatory agencies.

ICH was organized to provide an

opportunity for tripartite harmonization

initiatives to be developed with input

from both regulatory and industry

representatives. FDA also seeks input

from consumer representatives and

others. ICH is concerned with

harmonization of technical

requirements for the registration of

pharmaceutical products among three

regions: The European Union, Japan,

and the United States. The six ICH

sponsors are the European Commission,

the European Federation of

Pharmaceutical Industries Associations,

the Japanese Ministry of Health and

Welfare, the Japanese Pharmaceutical

Manufacturers Association, the Centers

for Drug Evaluation and Research and

Biologics Evaluation and Research,

FDA, and the Pharmaceutical Research

and Manufacturers of America. The ICH

Secretariat, which coordinates the

preparation of documentation, is

provided by the International

Federation of Pharmaceutical

Manufacturers Associations (IFPMA).

The ICH Steering Committee includes

representatives from each of the ICH

sponsors and the IFPMA, as well as

observers from the World Health

Organization, the Canadian Health

Protection Branch, and the European

Free Trade Area.

In accordance with the agency’s

regulation on good guidance practices

(GGP) (21 CFR 10.115; 65 FR 56468,

September 19, 2000), this document is

being called a guidance, rather than a

guideline.

To facilitate the process of making

ICH guidances available to the public,

the agency has changed its procedures

for publishing ICH guidances. Beginning

April 2000, we no longer include the

text of ICH guidances in the Federal

Register. Instead, we will publish a

notice in the Federal Register

announcing the availability of an ICH

guidance. The ICH guidance is placed in

the docket and can be obtained through

regular agency sources (see the

ADDRESSES section). Draft ICH guidances

are left in the original ICH format. Final

guidances are reformatted to conform to

the GGP style before publication.

In the Federal Register of September

24, 1999 (64 FR 51767), FDA published

a draft tripartite guidance entitled ‘‘E10

Choice of Control Group in Clinical

Trials.’’ The notice gave interested

persons an opportunity to submit

comments by December 23, 1999.