26914 Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Notices

rm. 1–23, 12420 Parklawn Dr.,

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 human drug

products, the testing phase begins when

the exemption to permit the clinical

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 AMARYL

(glimepiride). AMARYL is indicated

as an adjunct to diet and exercise to

lower the blood glucose in patients with

noninsulin-dependent (Type II) diabetes

mellitus (NIDDM) whose hyperglycemia

cannot be controlled by diet and

exercise alone. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for AMARYL (U.S. Patent

No. 4,379,785) from Hoechst

Atiengesellschaft, 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 1, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of AMARYL

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

AMARYL is 2,683 days. Of this time,

2,225 days occurred during the testing

phase of the regulatory review period,

while 458 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: July 28, 1988. FDA has

verified the applicant’s claim that the

date that the investigational new drug

application (IND) became effective was

on July 28, 1988.

2. The date the application was

initially submitted with respect to the

human drug product under section

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

Cosmetic Act: August 30, 1994. FDA has

verified the applicant’s claim that the

new drug application (NDA) for

AMARYL (NDA 20–496) was initially

submitted on August 30, 1994.

3. The date the application was

approved: November 30, 1995. FDA has

verified the applicant’s claim that NDA

20–496 was approved on November 30,

1995.

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 1,569 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before July 29, 1996, 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 November 25, 1996, 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: May 13, 1996.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 96–13311 Filed 5–28–96; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[HCFA–2567–A]

Emergency Clearance: Public

Information Collection Requirements

Submitted to the Office of Management

and Budget (OMB)

In compliance with the requirement

of section 3506(c)(2)(A) of the

Paperwork Reduction Act of 1995, the

Health Care Financing Administration

(HCFA), Department of Health and

Human Services (DHHS), has submitted

to the Office of Management and Budget

(OMB) the following request for

Emergency review. We are requesting an

emergency review because the

collection of this information is needed

prior to the expiration of the normal

time limits under OMB’s regulations at

5 C.F.R., Part 1320, in order to permit

recertification of OPOs as required by

statute. Failure to issue these rules in

time for the 1996 redesignation process

may result in the termination of OPO

agreements. This means that persons in

need of organs may not receive them.

The Agency cannot reasonably comply

with the normal clearance procedures

because public harm is likely to result

if normal clearance procedures are

followed. Without this information,

HCFA could not assure compliance with

this Congressional mandate.

HCFA is requesting that OMB review

this document on 5/31/96 and grant a

90-day approval. During this 90-day

period HCFA will publish a separate

Federal Register notice announcing the

initiation of an extensive 60-day agency

review and public comment period on

these requirements. Then HCFA will

submit the requirements for OMB

review and an extension of this

emergency approval.

Type of Information Collection

Request: Revision of a currently

approved collection; Title of

Information Collection: Statement of

Deficiencies and Plan of Correction;

Form No.: HCFA–2567–A; Use: This

Paperwork package provides

information regarding deficiencies for
Federal Register / Vol. 61, No. 104 / Wednesday, May 29, 1996 / Notices 26915

Organ Procurement Organizations

(OPO) as well as deficiencies noted

during periodic facility and laboratory

certification surveys. This information

is used to make decisions concerning

OPO redesignation, certification/

recertification of health care facilities

participating in the Medicare/Medicaid

Programs, and laboratories regulated by

CLIA. Frequency: Annually and

Biennially; Affected Public: State, Local

or Tribal Governments, Business or

other for-profit, Not-for-profit

institutions, Federal Government;

Number of Respondents: 49,200; Total

Annual Responses: 98,400; Total

Annual Hours Requested: 196,800.

To request copies of the proposed

paperwork collections referenced above,

call the Reports Clearance Office on

(410) 786–1326. Written comments and

recommendations for the proposed

information collections should be sent

by 5/31/96 to the OMB Desk Officer

designated at the following address:

OMB Human Resources and Housing

Branch, Attention: Allison Eydt, New

Executive Office Building, Room 10235,

Washington, D.C. 20503.

Dated: May 22, 1996.

Kathleen B. Larson,

Director, Management Planning and Analysis

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 96–13519 Filed 5–28–96; 8:45 am]

BILLING CODE 4120–03–P–M

National Institutes of Health

National Cancer Institute: Opportunity

for a Cooperative Research and

Development Agreement (CRADA) for

the Scientific and Commercial

Development of Hydroxylated

Aromatic Protein Cross-Linking

Compounds for the Treatment of

Hyperproliferative Epithelial Lesions

AGENCY: National Institutes of Health,

PHS, DHHS.

ACTION: Notice.

SUMMARY: The Department of Health and

Human Services (DHHS) seeks a

company that can collaboratively

pursue the pre-clinical and clinical

development of Hydroxylated Aromatic

Protein Cross-Linking Compounds for

the treatment of hyperproliferative

epithelial lesions including skin

neoplasia, warts and other

hyperproliferative skin disorders. The

National Cancer Institute, Laboratory of

Cellular Carcinogenesis and Tumor

Promotion (LCCTP) has established that

this class of compounds (cinnamic acid

derivatives) may be effective in treating

hyperproliferative skin disorders. The

selected sponsor will be awarded a

CRADA for the co-development of this

agent with the National Cancer Institute.

ADDRESS: Questions about this

opportunity may be addressed to Jeremy

A. Cubert, M.S., J.D., Office of

Technology Development, NCI, 6120

Executive Blvd., MSC 7182, Bethesda

MD 20892–7182, Phone: (301) 496–

0477, Facsimile: (301) 402–2117, from

whom further information may be

obtained.

DATE: In view of the important priority

of developing new agents for the

treatment or prevention of cancer,

interested parties should notify this

office in writing no later than July 12,

1996. Respondents will then be

provided an additional 30 days for the

filing of formal proposals.

SUPPLEMENTARY INFORMATION:

‘‘Cooperative Research Development

Agreement’’ or ‘‘CRADA’’ means the

anticipated joint agreement to be

entered into by NCI pursaunt to the

Federal Technology Transfer Act of

1986 and amendments (including 104

P.L. 113) and Executive Order 12591 of

October 10, 1987 to collaborate on the

specific research project described

below.

The Government is seeking a

pharmaceutical company which, in

accordance with the requirements of the

regulations governing the transfer of

agents in which the Government has

taken an active role in developing (37

CFR 404.8), can further develop the

subject compounds through Federal

Food and Drug Administration approval

and to a commercially available status

to meet the needs of the public and with

the best terms for the Government. The

government has applied for a patent

application directed to methods for the

treatment for Hyperproliferative

Epithelial Lesions by Topical

Application of Hydroxylated Aromatic

Protein Cross-Linking-Compounds.

Methyl 2,5-dihydroxycinnamate (MC),

a cinnamic acid derivative, has been

shown to both inhibit cell growth and

chemically cross-link proteins. The

growth inhibitory and protein crosslinking activity of MC are independent

and complementary. The cross-linking

effect of the compounds is rapid and

leads to programmed cell death for

many cell types. At lower

concentrations, the compounds inhibit

tyrosine kinases and cell growth. The

compounds have been shown to be

effective in many cell types indicating

potential for topical treatment of a wide

range of localized hyperproliferative

epithelial disorders.

The LCCTP, Division of Basic

Sciences, NCI is interested is

establishing a CRADA with a company

to assist in the continuing development

of these compounds. The Government

will provide all available expertise and

information to date and will jointly

pursue pre-clinical and clinical studies

as required, giving the company full

access to existing data and data

developed pursuant to the CRADA. The

successful company will provide the

necessary scientific, financial and

organizational support to establish

clinical efficacy and possible

commercial status of the subject

compounds.

The expected duration of the CRADA

will be two (2) to five (5) years.

The role of the National Cancer

Institute, includes the following:

1. Selection of appropriate compounds for

in vitro screening.

2. Selection of appropriate compounds for

in vivo screening.

3. Conduct in vitro screening of

appropriate compounds.

4. Identify chemical basis of activity for

class of compounds.

5. Conduct in vivo testing of appropriate

compounds.

6. Evaluation of test results.

7. Preparation of manuscripts for

publication.

8. Relevant Government intellectual

property rights are available for licensing

through the Office of Technology Transfer,

National Institutes of Health. For further

information contact Allan Kiang, J.D., NIH

Office of Technology Transfer, 6011

Executive Blvd., Suite 325, Rockville, MD

20852, Phone: (301) 496–7735 (ext. 270);

Facsimile: (301) 402–0220.

The role of the collaborator company,

includes the following:

1. Conduct in vitro screening of

appropriate compounds.

2. Identify chemical basis of activity for

class of compounds.

3. Conduct in vivo testing of appropriate

compounds.

4. Evaluation of test results.

5. Develop vehicle for delivery of

compounds to patients.

6. Conduct pre-clinical and clinical trials

of appropriate candidate compounds.

Criteria for choosing the company

include its demonstrated experience

and commitment to the following:

1. Scientific expertise in and

demonstraterd commitment to the treatment

of skin related disorders.

2. Scientific expertise in and demonstrated

commitment to the development of drug

delivery systems.

3. Experience in preclinical and clinical

drug development.

4. Experience and ability to produce,

package, market and distribute

pharmaceutical products.

5. Experience in the monitoring, evaluation

and interpretation of the data from