5432 Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices

the appendix for each application,

should be delivered to Robert L. Robins

(address above). No supplemental

material will be accepted after the

closing date. FDA’s authority to fund

research projects is under section 301 of

the PHS Act. FDA’s research program is

described in the Catalog of Federal

Domestic Assistance, No. 93.103.

Applications submitted under this

program must comply with 45 CFR part

46—Protection of Human Subjects

where applicable and requirements of

the Office of Protection from Research

Risks. The outside of the mailing

package and item 2 of the application

face page should be labeled ‘‘Response

to RFA–FDA–CDER–97–1’’.

VIII. Method of Application

A. Submission Instructions

Applications will be accepted during

normal working hours, 8 a.m. to 4:30

p.m., Monday through Friday, on or

before the March 14, 1997, deadline.

Applications will be considered

received on time if sent or mailed on or

before the receipt dates as evidenced by

a legible U.S. Postal Service dated

postmark or a legible date receipt from

a commercial carrier, unless they arrive

too late for orderly processing. Private

metered postmarks shall not be

acceptable as proof of timely mailing.

Applications not received on time will

not be considered for review and will be

returned to the applicant.

Note: (Applicants should note that the

U.S. Postal Service does not uniformly

provide dated postmarks. Before relying

on this method, applicants should check

with their local post office.)

B. Format for Application

Applications must be submitted on

Grant Application Form PHS 398 (Rev.

5/95). All ‘‘General Instructions’’ and

‘‘Specific Instructions’’ in the

application kit should be followed with

the exception of the receipt dates and

the mailing label address. Do not send

applications to the Division of Research

Grants, NIH. This information collection

is approved under OMB No. 00925–

0001. Applications from State and local

governments may be submitted on Form

PHS 5161 (Rev. 7/92) or PHS 398 (Rev.

5/95). The face page of the application

must reflect the request for applications

number RFA–FDA–CDER–97–1. This

information collection is approved

under OMB control number 0937–0189.

C. Legend

Unless disclosure is required by the

Freedom of Information Act as amended

(5 U.S.C. 552) as determined by the

freedom of information officials of the

Department of Health and Human

Services or by a court, data contained in

the portions of an application that have

been specifically identified by page

number, paragraph, etc., by the

applicant as containing confidential

commercial information or other

information that is exempt from public

disclosure will not be used or disclosed

except for evaluation purposes.

Dated: January 30, 1997.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 97–2870 Filed 2–4–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0362]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; DIFFERIN Topical Gel

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

DIFFERIN Topical Gel 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

Topical Gel (adapalene). DIFFERIN

Topical Gel 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

Topical Gel (U.S. Patent No. Re. 34,440)

from Centre International de Recherches

Dermatologiques (CIRD), 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 DIFFERIN

Topical Gel 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

DIFFERIN Topical Gel is 2,447 days. Of

this time, 1,401 days occurred during

the testing phase of the regulatory

review period, while 1,046 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 20, 1989.

FDA has verified the applicant’s claim

that the date that the investigational

new drug application became effective

was on September 20, 1989.

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
Federal Register / Vol. 62, No. 24 / Wednesday, February 5, 1997 / Notices 5433

Cosmetic Act: July 21, 1993. The

applicant claims July 15, 1993, as the

date the new drug application (NDA) for

DIFFERIN Topical Gel (NDA 20–380)

was initially submitted. However, FDA

records indicate that NDA 20–380 was

submitted on July 21, 1993.

3. The date the application was

approved: May 31, 1996. FDA has

verified the applicant’s claim that NDA

20–380 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 433 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before April 7, 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 August 4, 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. 97–2871 Filed 2–4–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[R–137]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

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, has submitted to the

Office of Management and Budget

(OMB) the following proposal for the

collection of information. Interested

persons are invited to send comments

regarding the burden estimate or any

other aspect of this collection of

information, including any of the

following subjects: (1) The necessity and

utility of the proposed information

collection for the proper performance of

the agency’s functions; (2) the accuracy

of the estimated burden; (3) ways to

enhance the quality, utility, and clarity

of the information to be collected; and

(4) the use of automated collection

techniques or other forms of information

technology to minimize the information

collection burden.

Type of Information Collection

Request: Reinstatement, with change, of

a previously approved collection for

which approval has expired; Title of

Information Collection: Internal

Revenue Service/Social Security

Administration/Health Care Financing

Administration Data Match 42 CFR

411.20–411.206; Form No.: HCFA–R–

137; Use: Employers who are identified

through a match of IRS, SSA, and

Medicare records will be contacted

concerning group health plan coverage

of identified individuals to ensure

compliance with Medicare Secondary

Payer provisions found at 42 U.S.C.

1395y(b). Frequency: Semi-annually

Affected Public: Individuals or

Households, Business or other for profit,

Not for profit institutions, Farms,

Federal Government and State, Local or

Tribal Government; Number of

Respondents: 596,241; Total Annual

Responses: 596,241; Total Annual

Hours Requested: 2,325,449.

To obtain copies of the supporting

statement for the proposed paperwork

collections referenced above, access

HCFA’s WEB SITE ADDRESS at http://

www.hcfa.gov, or to obtain the

supporting statement and any related

forms, E-mail your request, including

your address and phone number, to

Paperwork@hcfa.gov, or call the Reports

Clearance Office on (410) 786–1326.

Written comments and

recommendations for the proposed

information collections must be mailed

within 30 days of this notice directly to

the HCFA Paperwork Clearance 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: January 29, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–2764 Filed 2–4–97; 8:45 am]

BILLING CODE 4120–03–P

[HSQ–244–N]

CLIA Program; Clinical Laboratory

Improvement Amendments of 1988—

Denial of Exemption of Laboratories in

the Commonwealth of Puerto Rico

AGENCY: Health Care Financing

Administration (HCFA), HHS.

ACTION: Notice.

SUMMARY: The Public Health Service Act

provides for the exemption of

laboratories from the requirements of

the Clinical Laboratory Improvement

Amendments of 1988 (CLIA) if the State

in which they are located has been

determined to have requirements equal

to or more stringent than those of CLIA.

Under our regulations, HCFA’s decision

to approve or deny a requested

exemption from CLIA requirements is

published in the Federal Register. This

notice announces that a request from the

Commonwealth of Puerto Rico for

exemption from CLIA requirements has

been denied.

EFFECTIVE DATE: The denial of

exemption from CLIA was effective on

October 28, 1996.

FOR FURTHER INFORMATION CALL:

Lee Feehely, (410) 786–3401.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative

Authority

Section 353 of the Public Health

Service Act, as amended by the Clinical

Laboratory Improvement Amendments

of 1988 (CLIA), requires any laboratory

that performs tests on human specimens

to meet the requirements established by

the Department of Health and Human

Services. Regulations implementing

section 353 of the Public Health Service

Act are contained in 42 CFR part 493,

Laboratory Requirements. Subject to

specified exceptions included in

subpart D, laboratories must have a

current and valid CLIA certificate to test

human specimens. Section 353(p) of the

Public Health Service Act provides for

the exemption of laboratories from CLIA

requirements in a State that is