Federal Register / Vol. 62, No. 18 / Tuesday, January 28, 1997 / Notices 4067

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

CAMPTOSAR (irinotecan

hydrochloride). CAMPTOSAR is

indicated for the treatment of patients

with metastatic carcinoma of the colon

or rectum whose disease has recurred or

progressed following 5–FU based

therapy. Subsequent to this approval,

the Patent and Trademark Office

received a patent term restoration

application for CAMPTOSAR (U.S.

Patent No. 4,604,463) from Kabushiki

Kaisha Yakult Honsha, and the Patent

and Trademark Office requested FDA’s

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 CAMPTOSAR

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

CAMPTOSAR is 2,111 days. Of this

time, 1,941 days occurred during the

testing phase of the regulatory review

period, while 170 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 5, 1990.

FDA has verified the applicant’s claim

that the date that the investigational

new drug application became effective

was on September 5, 1990.

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: December 28, 1995. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

CAMPTOSAR (NDA 20–571) was

initially submitted on December 28,

1995.

3. The date the application was

approved: June 14, 1996. FDA has

verified the applicant’s claim that NDA

20–571 was approved on June 14, 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 1,139 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. 97–2067 Filed 1–27–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0361]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; DIFFERIN Solution

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

DIFFERIN Solution 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,

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 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 DIFFERIN

Solution (adapalene). DIFFERIN

Solution is indicated for the topical

treatment of acne vulgaris. Subsequent

to this approval, the Patent and

Trademark Office received a patent term

restoration application for DIFFERIN

Solution (U.S. Patent No. 5,015,758)

from Centre International de Recherches

Dermatologiques (CIRD), and the Patent

and Trademark Office requested FDA’s
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