6550 Federal Register / Vol. 62, No. 29 / Wednesday, February 12, 1997 / Notices

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 ULTIVATM

(remifentanil hydrochloride).

ULTIVATM is indicated for intravenous

administration as follows: (1) As an

analgesic agent for use during the

induction and maintenance of general

anesthesia for inpatient and outpatient

procedures, and for continuation as an

analgesic into the immediate

postoperative period under the direct

supervision of an anesthesia practitioner

in a postoperative anesthesia care unit

or intensive care setting; and (2) as an

analgesic component of monitored

anesthesia care. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for ULTIVATM (U.S. Patent

No. 5,019,583) from Glaxo Wellcome,

Inc., and the Patent and Trademark

Office requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

November 4, 1996, FDA advised the

Patent and Trademark Office that this

human drug product had undergone a

regulatory review period and that the

approval of ULTIVATM 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

ULTIVATM is 2,222 days. Of this time,

1,920 days occurred during the testing

phase of the regulatory review period,

while 302 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: June 14, 1990. FDA

has verified the applicant’s claim that

the date that the investigational new

drug application became effective was

on June 14, 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: September 15, 1995. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

ULTIVATM (NDA 20–630) was initially

submitted on September 15, 1995.

3. The date the human drug was

approved: July 12, 1996. FDA has

verified the applicant’s claim that NDA

20–630 was approved on July 12, 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 1,088 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before April 14, 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 May 5, 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 31, 1997.

Stuart L. Nightingale,

Associate Commissioner for Health Affairs.

[FR Doc. 97–3417 Filed 2–11–97; 8:45 am]

BILLING CODE 4160–01–F

Health Care Financing Administration

[Document Identifier: HCFA–9026]

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

AGENCY: Health Care Financing

Administration, HHS. In compliance

with the Paperwork Reduction Act of

1995 (44 U.S.C. 3501 et seq.), the Health

Care Financing Administration (HCFA),

Department of Health and Human

Services, has submitted to the Office of

Management and Budget (OMB) the

following proposals 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.

HCFA–9026 Type of Information

Collection Request: Reinstatement,

without change, of previously approved

collection for which approval has

expired; Title of Information Collection:

Intermediary Request to Hospitals for

Medical Information on Inpatient

Claims for Statutorily Excluded

Services/SSA 1862; 42 CFR 411.15; FR

Vol. 60, No. 181; Form No.: HCFA–

9026; Use: This information request is to

enable intermediaries to obtain hospital

medical records for inpatient claims

involving statutorily excluded services

and other non-covered services and

devices. 42 CFR 411.15 is the regulation

supporting this collection of

information; Frequency: On occasion;

Affected Public: Business or other for

profit, not for profit institutions, State,

local, or tribal governments, Federal

government; Number of Respondents:

5,258; Total Annual Responses: 20,355;

Total Annual Hours: 5,088.

To obtain copies of 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 should be sent

within 30 days of this notice directly 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: February 3, 1997.

Edwin J. Glatzel,

Director, Management Analysis and Planning

Staff, Office of Financial and Human

Resources, Health Care Financing

Administration.

[FR Doc. 97–3498 Filed 2–11–97; 8:45 am]

BILLING CODE 4120–03–P