4068 Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / Notices

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated October 24, 1996, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of DIFFERIN

Solution 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 had determinated that the

applicable regulatory review period for

DIFFERIN Solution is 2,814 days. Of

this time, 1,651 days occurred during

the testing phase of the regulatory

review period, while 1,163 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 18, 1988.

FDA has verified the applicant’s claim

that the date that the investigational

new drug application became effective

was on September 18, 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: March 26, 1993. The

applicant claims March 19, 1993, as the

date the new drug application (NDA) for

DIFFERIN Solution (NDA 20–338) was

initially submitted. However, FDA

records indicate that NDA 20–338 was

submitted on March 26, 1993.

3. The date the application was

approved: May 31, 1996. FDA has

verified the applicant’s claim that NDA

20–338 was approved on May 31, 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 257 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before March 31, 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 July 28, 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: January 17, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–2068 Filed 1–27–97; 8:45 am]

BILLING CODE 4160–01–F

National Institutes of Health

Submission for OMB Review;

Comment Request; NCI Cancer

Information Service Community

Services Database Survey and

Verification

SUMMARY: Under the provisions of

Section 3506(c)(2)(A) of the Paperwork

Reduction Act of 1995, the National

Cancer Institute (NCI), the National

Institutes of Health (NIH) has submitted

to the Office of Management and Budget

(OMB) a request to review and approve

the information collection listed below.

This proposed information collection

was previously published in the Federal

Register on May 3, 1996, page 19943

and allowed 60 days for public

comment. No public comments were

received. The purpose of this notice is

to allow an additional 30 days for public

comment. The National Institutes of

Health may not conduct or sponsor, and

the respondent is not required to

respond to, an information collection

that has been extended, revised, or

implemented on or after October 1,

1995, unless it displays a currently valid

OMB control number.

PROPOSED COLLECTION: Describe the

proposed information collection activity

as follows. Include:

Title: NCI Cancer Information Service

Community Services Database Survey

and Verification.

Type of Information Collection

Request: New.

Form Number: Not applicable.

Need and Use of Information

Collection: The CIS provides the general

public, cancer patients, families, health

professionals, and others with the latest

information on cancer. Essential to

fulfilling its role as a referral source for

cancer patients and their families is the

identification, acquisition, and

dissemination of information about

hospitals, breasts and cervical cancer

screening clinics, and cancer pain

management programs. This effort

involves sending a survey tool or a

verification instrument annually to

approximately 17,135 respondents.

Frequency of Response: Annual.

Affected Public: Not-for-profit

institutions; Business or other for-profit;

Federal Government; State, Local or

Tribal Government.

Type of Respondent: Administrators

of hospitals, pain centers, screening

facilities.

The annual reporting burden is as

follows:

Estimated Number of Respondents:

17,135 respondents.

Estimated Number of Responses per

Respondent: One (1) per year).

Average Burden Hours Per Response:

.167 hours.

Estimated Total Annual Burden

Hours Requested: 2,862 hours.

The annualized cost to respondents is

estimated at: $34,338.54. There are no

Capital Costs to report. There are no

Operating of Maintenance Costs to

report.

Type of respondents

Estimated

number of

respondents

Estimated

number of

responses

per respondent

Average

burden

hours per

response

Estimated

total annual

burden

hours requested

Year 1:

Administrators of hospitals, pain centers, screening facilities .................................. 18,027 1 0.167 3,011

Year 2:

New Organizations and verification .......................................................................... 16,605 1 0.167 2,773

Year 3:

New Organizations and verification .......................................................................... 16,774 1 0.167 2,801
Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / Notices 4069

Type of respondents

Estimated

number of

respondents

Estimated

number of

responses

per respondent

Average

burden

hours per

response

Estimated

total annual

burden

hours requested

Annualized Totals ...................................................................................................... 17,315 .................... .................... 2,862

REQUEST FOR COMMENTS: Written

comments and/or suggestions from the

public and affected agencies are invited

on one or more of the following points:

(1) Whether the proposed collection of

information is necessary for the proper

performance of the function of the

agency, including whether the

information will have practical utility;

(2) The accuracy of the agency’s

estimate of the burden of the proposed

collection of information, including the

validity of the methodology and

assumptions used; (3) Ways to enhance

the quality, utility, and clarity of the

information to be collected; and (4)

Ways to minimize the burden of the

collection of information on those who

are to respond, including the use of

appropriate automated, electronic,

mechanical, or other technological

collection techniques or other forms of

information technology.

DIRECT COMMENTS TO OMB: Written

comments and/or suggestions regarding

the item(s) contained in this notice,

especially regarding the estimated

public burden and associated response

time, should be directed to the: Office

of Management and Budget, Office of

Regulatory Affairs, New Executive

Office Building, Room 10235,

Washington, D.C. 20503, Attention:

Desk Officer for NIH. To request more

information on the proposed project or

to obtain a copy of the data collection

plans and instruments, contact: Chris

Thomsen, Acting Chief, Cancer

Information Service, RIB, OCC, OD, NCI,

Building 31, Room 10A16, 9000

Rockville Pike, Bethesda, MD 20892, or

call non-toll-free number (301) 496–

5583 ext. 239 or E-mail your request,

including your address to:

thomsenc@occ.nci.nih.gov

COMMENTS DUE DATE: Comments

regarding this information collection are

best assured of having their full effect if

received on or before February 27, 1997.

Dated: December 12, 1996.

Nancie L. Bliss,

OMB Project Clearance Liaison.

[FR Doc. 97–1982 Filed 1–27–97; 8:45 am]

BILLING CODE 4140–01–M

Government-Owned Inventions;

Availability for Licensing

AGENCY: National Institutes of Health.

ACTION: Notice.

The inventions listed below are

owned by agencies of the U.S.

Government and are available for

licensing in the U.S. in accordance with

35 U.S.C. 207 to achieve expeditious

commercialization of results of

federally-funded research and

development. Foreign patent

applications are filed on selected

inventions to extend market coverage

for U.S. companies and may also be

available for licensing.

ADDRESSES: Licensing information and

copies of the U.S. patent applications

listed below may be obtained by writing

to the indicated licensing contact at the

Office of Technology Transfer, National

Institutes of Health, 6011 Executive

Boulevard, Suite 325, Rockville,

Maryland 20852–3804 (telephone 301/

496–7057; fax 301/402–0220). An

signed Confidential Disclosure

Agreement (CDA) will be required to

receive copies of the patent

applications.

Immunotoxin (MAB–RICIN), for the

Treatment of Focal Movement

Disorders

J Hott, R Youle, M Hallet, M Dalakas

(NINDS)

Serial No. 60/027,458 filed 19 Sep 96

Licensing Contact: Stephen Finley, 301/

496–7735 ext 215

This invention describes the use of an

immunotoxin designed to treat focal

dystonias that are currently being

treated by injections of botulinum toxin

(BTX) or by surgical myectomy. The

immunotoxin (ITX) is prepared from a

monoclonal antibody (MoAb35),

specific to the nicotinic acetylcholine

receptor in skeletal muscle, and is

covalently linked to the toxin, ricin. ITX

utilizes ricin’s alpha chain and beta

chain for its improved potency. ITX’s

potency was demonstrated by

intramuscular injections into a rat

model. The effects of intermuscular

injections of ITX were compared to that

of BTX. Even lower doses of ITX proved

more effective and longer lasting than

BTX in weakening muscle. The ITX

selectively removed muscle fiber at the

injection sites. It is believed that ITX

may have clinical applications to those

patients who have become refractory to

BTX, or when used in combination or in

place of BTX. In addition to the use of

ITX in the treatment of all focal

muscular spasms, ITX may prove useful

in the treatment of other disorders of

muscular spasms such as

blepharospasms, cervical dystonia, hand

dystonia, limb dystonia, hemifacial

spasm, bruxism, strabismus, VI nerve

palsy, for spasmodic, dysphonia, and

oromandibular dystonia. (portfolios:

Central Nervious System—Therapeutics,

neurological, other; Central Nervous

System—Therapeutics, neurological,

muscle relaxants; Internal Medicine—

Therapeutics, other)

Methods and Compositions for p300/

CBP-Associated Transcriptional CoFactor (P/CAF)

Y Nakatani, B Howard (NICHD)

Serial No. 60/022,273 filed 23 Jul 96

Licensing Contact: Ken Hemby, 301/

496–7735 ext 265

The adenoviral oncoprotein E1A

induces cell transformation by binding

to various cellular components, such as

the products of the retinoblastoma and

p300/CBP gene families. This invention

provides a transcriptional co-factor,

p300/CBP-associated factor (P/CAF),

which has intrinsic histone acetylase

activity and also competes with E1A for

binding to cellular targets. Also

provided are methods of screening for

compounds that affect P/CAF activity.

Methods for directed gene therapy to

provide functional wild-type or mutant

P/CAF to cells producing varying levels

of P/CAF protein are also provided.

(portfolios: Cancer—Diagnostics;

Cancer—Therapeutics, biological

response modifiers; Devices—Research

Tools and Materials, biologicals and

chemicals)

Conformationally Locked Nucleoside

Analogs

VE Marquez, JB Rodriquez, MC

Nicklaus, JJ Barchi Jr, MA Siddiqui

(NCI)

Serial Number 08/311,425 filed 23 Sep

94 (with priority to 24 Sep 93) and

Conformationally Locked Nucleoside

Analogs as Antiherpetic Agents

VE Marquez, MC Nicklaus, JJ Barchi Jr,

JB Rodriguez, MA Siddiqui (NCI)

Serial Number 60/023,565 filed 07 Aug

96

Licensing Contact: Robert Benson, 301/

496–7056 ext 267