Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 / Notices 41263

review group, it will not be considered

unless you can provide proof that you

mailed it on or before the deadline (i.e.,

receipt from U.S. Postal Service or a

commercial carrier; private metered

postmarks are not acceptable).

G. Evaluation Criteria

Proposals are judged on the basis of

their scientific merit, the theoretical

importance of the research question and

the appropriateness of the proposed

data and methodology to be used in

addressing the question.

Each application will be evaluated

individually against the following

criteria by an independent review group

appointed by CDC.

1. Significance and originality of the

research.

2. Knowledge of research relevant to

the topic.

3. Appropriateness of methods and

data, including a description and

justification of the analytic techniques

that will be employed and a discussion

of the methodological problems that

might be encountered.

4. Availability and adequacy of data.

5. Organization of the project.

6. Adequacy of facilities and

resources. Human subjects involvement

and protection (when appropriate).

7. Representation of women and

minorities (when appropriate).

8. Appropriateness of the budget.

In evaluating applications and making

recommendations reviewers assess the

applicant’s potential for making

significant contributions to the field of

minority health statistics research.

Three factors influence the final

funding decisions on applications for

support of dissertations: (1) Reviewers’

evaluation of the application; (2) the

potential of the applicant to contribute

to the field; and (3) the general needs of

the field.

H. Other Requirements

Technical Reporting Requirements

Provide CDC with original plus two

copies of:

1. Annual progress reports;

2. Financial status report, no more

than 90 days after the end of the budget

period; and

3. Final financial status and

performance reports, no more than 90

days after the end of the project period.

Send all reports to David Elswick,

Grants Management Specialist, using

the address information listed under

Section J of this program announcement

entitled ‘‘Where to Obtain Additional

Information.’’

The following additional

requirements are applicable to this

program. For a complete description of

each, see Attachment I. included in the

application kit.

AR98–1 Human Subjects

Requirements

AR98–2 Requirements for Inclusion of

Women and Racial and Ethnic

Minorities in Research

AR98–4 HIV/AIDS Confidentiality

Provisions

AR98–9 Paperwork Reduction Act

Requirements

AR98–10 Smoke-Free Workplace

Requirements

AR98–11 Healthy People 2000

AR98–12 Lobbying Restrictions

AR98–13 Prohibition on Use of CDC

Funds for Certain Gun Control

Activities

AR98–14 Accounting System

Requirements

AR98–15 Proof of Non-Profit Status

I. Authority and Catalog of Federal

Domestic Assistance Number

This program is authorized under

section 306(m) of the Public Health

Service Act (42 U.S.C. 242k(m)), as

amended. The Catalog of Federal

Domestic Assistance number is 93.283.

J. Where To Obtain Additional

Information

To receive additional written

information call 1–888-GRANTS4. You

will be asked to leave your name,

address, and phone number and will

need to refer to Announcement 98100.

You will receive a complete program

description, information on application

procedures, and application forms. CDC

will not send application kits by

facsimile or express mail.

Please refer to announcement number

98100 when requesting information and

submitting an application.

If you have questions after reviewing

the contents of all the documents,

business management technical

assistance may be obtained by

contacting: David Elswick, Grants

Management Specialist, Grants

Management Branch, Procurement and

Grants Office, Announcement 98100,

Centers for Disease Control and

Prevention (CDC), Room 300, 255 East

Paces Ferry Road, NE., M/S E–13,

Atlanta, GA 30305–2209, telephone

(404)842–6521.

See also the CDC home page on the

Internet: http://www.cdc.gov

For program technical assistance,

contact: Audrey L. Burwell, M.S.,

Minority Health Statistics Grants

Program Director, National Center for

Health Statistics, CDC, 6525 Belcrest

Road, Room 1100, Hyattsville, MD

20782, Telephone: (301) 436–7062,

extension 127, Email: AZB2@CDC.GOV.

Website: www.cdc.gov/nchswww/

about/grants/grants1.htm.

Dated: July 28, 1998.

John L. Williams,

Director, Procurement and Grants Office,

Centers for Disease Control and Prevention

(CDC).

[FR Doc. 98–20575 Filed 7–31–98; 8:45 am]

BILLING CODE 4163–18–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96E–0314]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; GEMZAR

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

GEMZAR 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 drug product.

ADDRESSES: Written comments and

petitions should be directed to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6620.

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 human drug

products, the testing phase begins when

the exemption to permit the clinical
41264 Federal Register / Vol. 63, No. 148 / Monday, August 3, 1998 / Notices

investigations of the drug 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

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 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 GEMZAR

(gemcitabine hydrochloride).

GEMZAR is indicated for use as a

firstline treatment for patients with

locally advanced (nonresectable stage II

or stage III) or metastatic (stage IV)

adenocarcinoma of the pancreas in

patients previously treated with 5–FU.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

GEMZAR (U.S. Patent No. 4,808,614)

from Eli Lilly & Co., and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated March 7, 1997, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of GEMZAR

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

GEMZAR is 3,293 days. Of this time,

2,824 days occurred during the testing

phase of the regulatory review period,

469 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: May 12, 1987.

The applicant claims June 18, 1987, as

the date the investigational new drug

application (IND) for GEMZAR

became effective. However, FDA records

indicate that the IND effective date was

May 12, 1987, 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: February 2, 1995. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

GEMZAR (NDA 20–509) was initially

submitted on February 2, 1995.

3. The date the application was

approved: May 15, 1996. FDA has

verified the applicant’s claim that NDA

20–509 was approved on May 15, 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 1,537 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before October 2, 1998, 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 February 1, 1999, 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: July 8, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–20593 Filed 7–31–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

District Consumer Forum; Notice of

Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice of meeting.

The Food and Drug Administration’s

(FDA’s), Office of Consumer Affairs

(OCA) the Office of Regulatory Affairs

(ORA) offices in Illinois, Michigan, and

Indiana in cooperation with the U.S.

Dept. of Health and Human Services

Office of Minority Health, Office of

Public Health Sciences, Region V,

Illinois Department of Public Health,

Center for Minority Health Services and

Asian Health Coalition of Illinois,

Chicago Department of Health, Chicago

Hispanic Health Coalition, U. S.

Department of Agriculture Food and

Nutrition Service, Regional Office,

Midwest Field Office, Health Resources

and Services Administration, and the

University of Illinois Extension Chicago

Cooperative Extension Center is

announcing a district consumer forum.

The forum will provide an opportunity

for consumers, community-based

organizations, patient advocates, health

professionals, and industry to

participate in open discussions on

health issues and agency regulatory

actions with FDA officials.

Date and Time: The forum will be

held on Tuesday, August 18, 1998, from

10 a.m. to 1 p.m.

Location: The forum will be held at

the Sears Tower, 233 South Wacker Dr.,

Lincoln Ballroom, 33d Fl., Chicago, IL

60606.

Contact: Kimberly Phillips, Chicago

District Office, Office of Regulatory

Affairs, 300 South Riverside Plaza, suite

550–South, Chicago, IL 60606, 312–

353–7126, FAX 312–886–3280.

Registration: Send registration

information (including name, title, firm

name, address, telephone, and fax

number) to the contact person by

August 10, 1998. Every effort will be

made to accommodate all registrants.

However because space is limited,

admittance is on a ‘‘first come, first

serve basis.’’

If you need special accommodations

due to a disability, please contact

Kimberly Phillips (address above) by

August 10, 1998.

Transcripts: Transcripts of the forum

may be requested in writing from the

Freedom of Information Office (HFI–35),

Food and Drug Administration, 5600

Fishers Lane, rm. 12A–16, Rockville,

MD 20857, approximately 15 working

days after the forum, at a cost of 10

cents per page.

Dated: July 28, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20595 Filed 7–31–98; 8:45 am]

BILLING CODE 4160–01–F