46500 Federal Register / Vol. 62, No. 170 / Wednesday, September 3, 1997 / Notices

Copies of the information collection

packages listed above can be obtained

by calling the OS Reports Clearance

Officer on (202) 690–6207. Written

comments and recommendations for the

proposed information collection should

be sent directly to the OMB desk officer

designated above at the following

address: Human Resources and Housing

Branch, Office of Management and

Budget, New Executive Office Building,

Room 10235, 725 17th Street NW.,

Washington, DC 20503.

Comments may also be sent to

Cynthia Agens Bauer, OS Reports

Clearance Officer, Room 503H,

Humphrey Building, 200 Independence

Avenue SW., Washington, DC 20201.

Written comments should be received

within 30 days of this notice.

Dated: August 27, 1997.

William R. Beldon,

Acting Deputy Assistant Secretary, Budget.

[FR Doc. 97–23304 Filed 9–2–97; 8:45 am]

BILLING CODE 4150–04–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Notice of Two Meetings of the National

Bioethics Advisory Commission

(NBAC): One Each of its Genetics and

Human Subjects Subcommittees

SUMMARY: Pursuant to Section 10(d) of

the Federal Advisory Committee Act, as

amended (5 U.S.C. Appendix 2), notice

is given of two meetings of the National

Bioethics Advisory Commission.

Commission members will solicit

testimony on the protection of the rights

and welfare of human subjects in

research including decisionally and/or

cognitively impaired populations and

will address the use of genetic

information involved in tissue storage.

The meetings are open to the public and

opportunities for statements by the

public will be provided.

DATES/TIMES/LOCATIONS:

Human Subjects Subcommittee

September 18, 1997, 8:15 am–5:30 pm,

(9:00 am–12 noon public hearing)—

National Institutes of Health, 9000

Rockville Pike, Building 31, 6th Floor,

Conference Room 10, Bethesda,

Maryland 20892

Genetics Subcommittee

September 18, 1997, 3:00 pm–5:30 pm—

National Institutes of Health, 9000

Rockville Pike, Building 31, 6th Floor,

Conference Room 9, Bethesda,

Maryland 20892

September 19, 1997, 8:30 am–12:30

pm—Same Location as Above

SUPPLEMENTARY INFORMATION: The

President established the National

Bioethics Advisory Commission (NBAC)

by Executive Order 12975 on October 3,

1995. The mission of the NBAC is to

advise and make recommendations to

the National Science and Technology

Council and other entities on bioethical

issues arising from the research on

human biology and behavior, and in the

applications of that research including

clinical applications.

Public Participation

All meetings are open to the public

with attendance limited by the

availability of space. On September 18,

1997, the Human Subjects

Subcommittee of the National Bioethics

Advisory Commission will discuss

possible guidelines for research

involving decisionally or cognitively

impaired subjects, and public testimony

is invited on the ethical issues of such

research. A public hearing will be held

on ethical issues in research involving

decisionally or cognitively impaired

individuals from 9:00 am—12 noon on

September 18, 1997. Members of the

public who wish to present oral

statements should contact the Deputy

Executive Director of the NBAC by

telephone, fax machine, or mail as

shown below prior to the meeting as

soon as possible. Individuals unable to

make oral presentations are encouraged

to mail or fax their comments to the

NBAC staff office for distribution to the

subcommittee members or Commission

and inclusion in the public record.

Persons needing special assistance,

such as sign language interpretation or

other special accommodations, should

contact NBAC staff at the address or

telephone number listed below as soon

as possible.

FOR FURTHER INFORMATION CONTACT: Ms.

Henrietta D. Hyatt-Knorr, National

Bioethics Advisory Commission, MSC–

7508, 6100 Executive Boulevard, Suite

5B01, Rockville, Maryland 20892–7508,

telephone 301–402–4242, fax number

301–480–6900.

Dated: August 28, 1997.

Henrietta D. Hyatt-Knorr,

Deputy Executive Director, Acting, National

Bioethics Advisory Commission.

[FR Doc. 97–23377 Filed 9–2–97; 8:45 am]

BILLING CODE 4160–17–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0353]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that the proposed collection of

information listed below has been

submitted to the Office of Management

and Budget (OMB) for review and

clearance under the Paperwork

Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the

collection of information by October 3,

1997.

ADDRESSES: Submit written comments

on the collection of information to

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Wolff, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In

compliance with section 3507 of the

PRA (44 U.S.C. 3507), FDA has

submitted the following proposed

collection of information to OMB for

review and clearance:

Food Additives and Food Additive

Petitions (21 CFR Parts 171, 172, 173,

175 to 178, and 180) (OMB Control

Number 0910–0016—Reinstatement)

Section 409(a) of the Federal Food,

Drug, and Cosmetic Act (the act) (21

U.S.C. 348(a)) provides that any

particular use or intended use of a food

additive shall be deemed to be unsafe,

unless the additive and its use or

intended use are in conformity with a

regulation issued under section 409 of

the act that describes the condition(s)

under which the additive may be safely

used, or unless the additive and its use

or intended use conform to the terms of

an exemption for investigational use.

Food additive petitions are submitted by

individuals or companies to obtain

approval of a new food additive or to

amend the conditions of use permitted

under an existing food additive

regulation. Section 171.1 (21 CFR 171.1)
Federal Register / Vol. 62, No. 170 / Wednesday, September 3, 1997 / Notices 46501

specifies the information that a

petitioner must submit in order to

establish that the proposed use of a food

additive is safe and to secure the

publication of a food additive regulation

describing the conditions under which

the additive may be safely used. Parts

172, 173, 175 to 178, and 180 (21 CFR

parts 172, 173, 175 to 178, and 180)

contain labeling requirements for

certain food additives to ensure their

safe use.

FDA scientific personnel review food

additive petitions to ensure the safety of

the intended use of the food additive in

or on food, or of a food additive that

may be present in food as a result of its

use in articles that contact food. FDA

requires food additive petitions to

contain the information specified in

§ 171.1 in order to determine whether a

petitioned use for a food additive is safe,

as required by the act. This regulation

(§ 171.1) implements section 409(b)(2)

of the act.

Respondents are businesses engaged

in the manufacture or sale of food, food

ingredients, or substances used in

materials that come into contact with

food.

FDA estimates the burden of

complying with the information

collection provisions of the agency’s

food additive petition regulations as

follows:

TABLE 1. — ESTIMATED ANNUAL REPORTING BURDEN

21 CFR No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

171.1 44 1 44 2,876 126,560

Part 172 44 1 44 0 0

Part 173 44 1 44 0 0

Parts 175 to 178 44 1 44 0 0

Part 180 44 1 44 0 0

Total 44 126,560

There are no capital costs or operating and maintenance costs associated with this collection.

This estimate is based on the average

number of new food additive petitions

received in fiscal year 1995 and the total

hours expended by petitioners to

prepare the petitions. The burden varies

with the complexity of the petition

submitted, because food additive

petitions involve the analysis of

scientific data and information, as well

as the work of assembling the petition

itself. Because labeling requirements

under parts 172, 173, 175 to 178, and

180 for particular food additives involve

information required as part of the food

additive petition safety review process

under § 171.1, the estimate for the

number of respondents is the same and

the burden hours for labeling are

included in the estimate for § 171.1.

Dated: August 26, 1997.

William B. Schultz,

Deputy Commissione for Policy.

[FR Doc. 97–23246 Filed 9–2–97; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0145]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; PRELAYTM and REZULINTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

PRELAYTM and REZULINTM 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 products PRELAYTM

and REZULINTM (troglitazone).

PRELAYTM and REZULINTM are

indicated for use in patients with type

II diabetes currently on insulin therapy

whose hyperglycemia is inadequately

controlled (HbAlc>8.5%) despite insulin

therapy of over 30 units per day given

as multiple injections. Subsequent to

this approval, the Patent and Trademark

Office received a patent term restoration

application for PRELAYTM and

REZULINTM (U.S. Patent No. 4,572,912)

from Sankyo Co., Ltd., and the Patent

and Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated January 21, 1997, FDA

advised the Patent and Trademark