31178 Federal Register / Vol. 65, No. 95 / Tuesday, May 16, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

Submission for OMB Review;

Comment Request

Title: Head Start Training and

Technical Assistance Assessment.

OMB No.: New Collection.

Description: This data will be used to

assess the Head Start Training and

Technical Assistance (T/TA) delivery

system. Data collected will provide

information on the quality of services

that Head Start Quality Improvement

Centers (QICs) provide to Head Start

grantees. Respondents will include QIC

staff, collaborative partners of QIC

organizations, and Head Start grantees.

Specifically, site visit interviews will be

conducted with QIC Directors and QIC

Area Specialists, while telephone

interviews will be conducted with QIC

Directors, Grantee Directors, and Partner

Agencies.

Training and technical assistance are

critical in supporting the continuous

improvement efforts of Head Start

grantee and delegate agencies serving

children birth to five and their families.

The reports of the Advisory Committee

on Head Start Quality and Expansion in

December 1993 and the Advisory

Committee on Services for Families

with Infants and Toddlers reaffirmed

the importance of T/TA to support

program quality. The Head Start Act of

1994 (P.L. 103–252) also emphasized

the importance of T/TA and stated that

T/TA activities must ensure that needs

of local Head Start agencies relating to

improving program quality and

expansion are addressed to the

maximum extent feasible.

The assessment is designed to gather

information for program management

and planning purposes about the kind

and quality of services provided by each

QIC. Information collected will be used

by the Bureau to: (1) identify the quality

of approaches undertaken in each phase

of the strategic planning cycle; (2)

identify any patterns or changes over

time in the delivery of T/TA; and (3)

determine the feasibility of future

initiatives and funding decisions. The

data collected will provide a means for

the Head Start Bureau to carry out the

Federal role outlined in the Cooperative

Agreement establishing the QICs. These

data also may be used, in part, to fulfill

the Department’s requirement to report

to Congress on the Head Start program

under the Government Performance and

Results Act (GPRA).

Respondents:

Head Start Quality Improvement

Centers (QIC), Head Start Grantees,

Head StartPartner Agencies.

ANNUAL BURDEN ESTIMATES

Instrument Number of

respondents

Number of responses per

respondent

Average burden hours per

response

Total burden

hours

QIC Director Site Visit Interview ...................................................................... 28 30 .1 84

QIC Area Specialists Site Visit Interview ......................................................... 116 19 .16 353

QIC Director Telephone Interview ................................................................... 28 8 .19 42

HS Partner Agency Telephone Interview ........................................................ 112 11 .09 112

Grantee Director Telephone Interview ............................................................. 256 18 .11 512

Estimated Total Annual Burden Hours: .................................................... ........................ ........................ ........................ 1,103

Additional Information: Copies of the

proposed collection may be obtained by

writing to The Administration for

Children and Families, Office of

Information Services, 370 L’Enfant

Promenade, SW, Washington, DC 20447,

Attn: ACF Reports Clearance Officer.

OMB Comment: OMB is required to

make a decision concerning the

collection of information between 30

and 60 days after publication of this

document in the Federal Register.

Therefore, a comment is best assured of

having its full effect if OMB receives it

within 30 days of publication. Written

comments and recommendations for the

proposed information collection should

be sent directly to the following: Office

of Management and Budget, Paperwork

Reduction Project, 725 17th Street, NW,

Washington, DC 20503, Attn: Desk

Officer for ACF.

Dated: May 9, 2000.

Bob Sargis,

Reports Clearance Officer.

[FR Doc. 00–12250 Filed 5–15–00; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1268]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Food Additives

and Food Additive Petitions

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing an

opportunity for public comment on the

proposed collection of certain

information by the agency. Under the

Paperwork Reduction Act of 1995 (the

PRA), Federal agencies are required to

publish notice in the Federal Register

concerning each proposed collection of

information, including each proposed

extension of an existing collection of

information, and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

requirements relating to the approval

and labeling of food additives.

DATES: Submit written comments on the

collection of information by July 17,

2000.

ADDRESSES: Submit written comments

on the collection of information to the

Dockets Management Branch (HFA–

305), Food and Drug Administration,

5630 Fishers Lane, rm. 1061, Rockville,

MD 20852. All comments should be

identified with the docket number

found in brackets in the heading of this

document.

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: Under the

PRA (44 U.S.C. 3501–3520), Federal

agencies must obtain approval from the

Office of Management and Budget

(OMB) for each collection of

information they conduct or sponsor.

‘‘Collection of information’’ is defined

in 44 U.S.C. 3502(3) and 5 CFR

1320.3(c) and includes agency requests

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