Federal Register / Vol. 65, No. 95 / Tuesday, May 16, 2000 / Notices 31179

or requirements that members of the

public submit reports, keep records, or

provide information to a third party.

Section 3506(c)(2)(A) of the PRA (44

U.S.C. 3506(c)(2)(A)) requires Federal

agencies to provide a 60-day notice in

the Federal Register concerning each

proposed collection of information,

including each proposed extension of an

existing collection of information,

before submitting the collection to OMB

for approval. To comply with this

requirement, FDA is publishing notice

of the proposed collection of

information set forth in this document.

With respect to the following

collection of information, FDA invites

comments on: (1) Whether the proposed

collection of information is necessary

for the proper performance of FDA’s

functions, including whether the

information will have practical utility;

(2) the accuracy of FDA’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 respondents, including through the

use of automated collection techniques,

when appropriate, and other forms of

information technology.

Food Additives and Food Additive

Petitions—21 CFR 171.1 and Parts 172,

173, 175 through 178, and 180—(OMB

Control Number 0910–0016)—Extension

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, or

unless a food contact notification

submitted under paragraph (h) is

effective. 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) 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 through 178, and 180 (21

CFR parts 172, 173, 175 through 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 this

collection of information as follows:

TABLE1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section/Part No. of Respondents

Annual Frequency per Response

Total Annual

Responses

Hours per Response Total Hours

171.1 13 1 13 5,332 69,316

Part 172 13 1 13 0 0

Part 173 13 1 13 0 0

Parts 175 through 178 13 1 13 0 0

Part 180 13 1 13 0 0

Total 69,316

1There are no capital costs or operating and maintenance costs associated with this collection of information.

This estimate is based on the number

of new food additive petitions received

in fiscal year 1999 and the total hours

expended by petitioners to prepare the

petitions. A reduction was estimated

based on expected eligibility of some

substances previously submitted as food

additive petitions for submission as

food contact notices under new section

409(h) of the the act. 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 through 178,

and 180 for particular food additives

involve information required as part of

the food 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: May 9, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–12181 Filed 5–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 99N–5325]

Agency Information Collection

Activities; Announcement of OMB

Approval; Irradiation in the Production,

Processing, and Handling of Food

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Irradiation in the Production,

Processing, and Handling of Food’’ has

been approved by the Office of

Management and Budget (OMB) under

the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 22, 2000 (65

FR 15343), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

31180 Federal Register / Vol. 65, No. 95 / Tuesday, May 16, 2000 / Notices

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0186. The

approval expires on April 30, 2003. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: May 9, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–12179 Filed 5–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Science Advisory Board to the

National Center for Toxicological

Research Advisory Committee; Notice

of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration

(FDA). At least one portion of the

meeting will be closed to the public.

Name of Committee: Science

Advisory Board (the Board) to the

National Center for Toxicological

Research (NCTR).

General Function of the Committee:

To provide advice and

recommendations to the agency on

FDA’s regulatory issues.

Date and Time: The meeting will be

held on June 5, 2000, 1 p.m. to 4:30

p.m., and June 6, 2000, 8:30 a.m. to 1

p.m.

Location: NCTR, Bldg. #12,

Conference Center, Jefferson, AR.

Contact Person: Ronald F. Coene,

NCTR (HFT–10), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–6696, or

FDA Advisory Committee Information

Line, 1–800–741–8138 (301–443–0572

in the Washington, DC area), code

12559. Please call the Information Line

for up-to-date information on this

meeting.

Agenda: The Board will be presented

with draft reports on evaluations of

NCTR’s research programs in Endocrine

Disrupter Knowledge Base, and

Microbiology, for their review,

discussion, and approval. The draft

reports are the products of two site visit

teams who conducted on site reviews

over the last year. The staff from these

programs will provide a preliminary

response to the issues raised and

recommendations made. Three progress

reports will be presented to the Board

on the recommendations it made at its

last meeting, as a result of earlier site

visits, on NCTR’s programs in BioChem

Toxicology, Genetic Toxicology and

Molecular Epidemiology. The NCTR

Acting Director will also provide a

Center update and a discussion of future

research directions.

Procedure: On June 5, 2000, from 1

p.m. to 4:30 p.m., and June 6, 2000,

from 8:30 a.m. to 12 noon, the meeting

is open to the public. Interested persons

may present data, information, or views,

orally or in writing, on issues pending

before the committee. Written

submissions may be made to the contact

person by May 23, 2000. Oral

presentations from the public will be

scheduled between approximately 11

a.m. and 12 noon on June 6, 2000. Time

allotted for each presentation may be

limited. Those desiring to make formal

oral presentations should notify the

contact person before May 23, 2000, and

submit a brief statement of the general

nature of the evidence or arguments

they wish to present, the names and

addresses of proposed participants, and

an indication of the approximate time

requested to make their presentation.

Closed Committee Deliberations: On

June 6, 2000, from 12 noon to 1 p.m.,

the meeting will be closed to permit

discussion where disclosure would

constitute a clearly unwarranted

invasion of personal privacy (5 U.S.C.

552b(c)(6)). This portion of the meeting

will be closed to permit discussion of

information concerning individuals

associated with the research programs at

NCTR.

The Commissioner of Food and Drugs

approves the scheduling of meetings at

locations outside the Washington, DC

area on the basis of the criteria of 21

CFR 14.22 of FDA’s regulations relating

to public advisory committees.

Notice of this meeting is given under

the Federal Advisory Committee Act (5

U.S.C. app. 2).

Dated: May 5, 2000.

Linda A. Suydam,

Senior Associate Commissioner.

[FR Doc. 00–12180 Filed 5–15–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Fiscal Year (FY) 2000 Funding

Opportunities

AGENCY: Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Notice of Funding Availability.

SUMMARY: The Substance Abuse and

Mental Health Services Administration

(SAMHSA) Center for Substance Abuse

Treatment (CSAT) announces the

availability of FY 2000 funds for grants

for the following activity. This activity

is discussed in more detail under

Section 3 of this notice. This notice is

not a complete description of the

activity; potential applicants must

obtain a copy of the Program

Announcement, including Part I,

Programmatic Guidance for Grants to

Expand Substance Abuse Treatment

Capacity in Targeted Areas of Need, and

Part II, General Policies and Procedures

Applicable to all SAMHSA Applications

for Discretionary Grants and

Cooperative Agreements, before

preparing an application.

Activity Application deadline Est. funds FY 2000 Est. No. of awards

Cooperative Agreement for a National Center for

Mentally Ill and Substance Abusing Youth and

Adults Involved with the Justice System.

July 21, 2000 ................. Up to $1,200,000 ........... 1 Up to 3 years.

The actual amount available for

awards and their allocation may vary,

depending on unanticipated program

requirements and the number and

quality of applications received. FY

2000 funds for the activity discussed in

this announcement were appropriated

by the Congress under Public Law No.

106–113. SAMHSA’s policies and

procedures for peer review and

Advisory Council review of grant and

cooperative agreement applications

were published in the Federal Register

(Vol. 58, No. 126) on July 2, 1993.