40716 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Notices

period beginning the year before the

divestiture. Staff estimates that the

burden on each participant to provide

this information will be 4 hours, for a

total of 348 hours (51 buyers + 36

respondents = 87, 87 × 4 = 348). The

total cumulative burden of the

document production and chart

completion will be 522 hours (174+348).

The estimated total burden for the entire

study is therefore calculated to be 825

hours (303+522), which has been

rounded to 1,000 hours to allow for

small additions such as interviews with

and follow-up document requests of

subsequent buyers.

Estimate of information collection

annual labor cost burden: $75,000.

It is difficult to calculate reliably the

costs associated with this information

collection, as they entail varying

compensation levels of executives,

management, and/or support staff

among many companies and various

industries. Individuals among some or

all of those labor categories may be

involved in the information collection

process. Nonetheless, assuming that

responses to interviews, the

questionnaire, and the document

request are handled by executive and

mid-management level personnel alone,

and applying a blended average hourly

compensation rate of $75/hour for their

labor, the total cost should not exceed

$75,000 (based on the upward rounding

of estimated total hourly burden for the

study).

Estimate of information collection

annual capital and operating cost

burden: None.

The data for the study are being

collected in two principal ways. Staff is

conducting telephone interviews and

asking respondents and buyers to

respond to a brief questionnaire and

produce existing documents. None of

these means of collecting information

requires any capital expenditure.

Interviews solely involve respondents

and buyers making available one or

more company officials for

approximately 11⁄2 hours. The

questionnaires and document requests

seek only information that the

respondents and buyers maintain in the

ordinary and usual course of their

business. No additional cost burden is

imposed.

Debra A. Valentine,

General Counsel.

[FR Doc. 98–20298 Filed 7–29–98; 8:45 am]

BILLING CODE 6750–01–M

GENERAL SERVICES

ADMINISTRATION

Fleet Management Division;

Cancellation of Standard Forms

AGENCY: Federal Supply Service,

General Services Administration.

ACTION: Notice.

SUMMARY: This notice announces the

General Services Administration’s

intent to cancel the following Standard

forms:

SF 149, U.S. Government National

Credit Card, and SF 149A, U.S.

Government Fleet Credit Card.

Both of these forms were replaced

with a bank credit card.

DATES: Effective July 30, 1998.

FOR FURTHER INFORMATION CONTACT:

Mr. William Webster, Environmental

and Legislation Branch (703) 305–6276.

This contact is for information on the

new fleet services credit card only.

Dated: July 20, 1998.

Barbara M. Williams,

Deputy Standard and Optional Forms

Management Officer.

[FR Doc. 98–20334 Filed 7–29–98; 8:45 am]

BILLING CODE 6820–34–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Administration for Children and

Families

President’s Committee on Mental

Retardation; Meeting

AGENCY: President’s Committee on

Mental Retardation.

TIME AND DATE: August 28, 1998, 8 a.m.–

2 p.m.

PLACE: Renassaince Mayflower Hotel,

1127 Connecticut Avenue, NW.,

Washington, DC. 20036.

STATUS: Full Committee Meetings are

open to the public. An interpreter for

the deaf will be available upon advance

request. All meeting sites are barrier

free.

MATTERS TO BE CONSIDERED: The

Committee plans to discuss critical

issues concerning Federal Policy,

Federal Research and Demonstration,

State Policy Collaboration, Minority and

Cultural Diversity and Mission and

Public Awareness, relating to

individuals with mental retardation.

The PCMR acts in an advisory

capacity to the President and the

Secretary of the U.S. Department of

Health and Human Services on a broad

range of topics relating to programs,

services, and supports for persons with

mental retardation. The Committee, by

Executive Order, is responsible for

evaluating the adequacy of current

practices in programs and supports for

persons with mental retardation, and for

reviewing legislative proposals that

impact the quality of life that is

experienced by citizens with mental

retardation and their families.

CONTACT PERSON FOR MORE INFORMATION:

Gary H. Blumenthal, 352–G Hubert H.

Humphrey Building, 200 Independence

Avenue, SW., Washington, DC. 20201–

0001; (202) 619–0634.

Dated: July 24, 1998.

John L. Pride,

Deputy Executive Director, PCMR.

[FR Doc. 98–20420 Filed 7–29–98; 8:45 am]

BILLING CODE 4184–01–M

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0572]

Agency Information Collection

Activities: Proposed Collection;

Comment Request

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 and to allow 60 days for

public comment in response to the

notice. This notice solicits comments on

the proposed collection of information

concerning a pilot program in which

volunteers from the retail food industry

will use Hazard Analysis Critical

Control Point (HACCP) principles and

partner with interested regulatory

authorities in the program

implementation.

DATES: Submit written comments on the

collection of information by September

28, 1998.

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.
Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Notices 40717

FOR FURTHER INFORMATION CONTACT:

Margaret R. 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

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

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.

Collection of Letters of Interest and

Food Safety Data by Retail Food

Operators in a Voluntary Pilot Program

using HACCP Principles

Section 301 (21 U.S.C. 331 et seq.) of

the Federal Food, Drug, and Cosmetic

Act enables FDA to ensure that foods in

interstate commerce are safe. In

addition, under authority granted in the

Public Health Service Act (42 U.S.C. 243

et seq.), the agency engages in a range

of activities intended to ensure safety of

the nation’s food supply, from

regulating food when it can be a vector

of disease to assisting, and cooperating

with, the States to ensure effective State

and local food safety programs. FDA

endeavors to assist the more than 3,000

Federal, tribal, State, and local

regulatory agencies that have primary

responsibility for monitoring retail food

establishments to ensure that consumers

are protected.

FDA is proposing to collect

information, through a voluntary pilot

program, on how HACCP principles

might be implemented in the retail food

industry. The pilot program is designed

to provide insight into the problems,

costs, and benefits of developing and

implementing HACCP principles for

food service, retail food stores, and

other retail food establishments, in

order to improve and provide direct

guidance to both the retail industry and

regulatory authorities for the

implementation of HACCP principles in

the retail food sector. FDA will select

candidates with a goal of ensuring that

the participants in the program cross the

spectrum of retail activities, have a

range of scientific capabilities, have

facilities of varying sizes, and have a

range of HACCP experience. FDA has

been approached by State and local

governments to provide guidance for

applying HACCP principles at retail,

therefore the agency intends to collect

information through the pilot program

to develop and enhance guidance. The

agency intends to make a summary of

the results of the retail pilot program

publicly available.

The agency will request interested

retail food establishments along with

regulatory authorities interested in

participating in the pilot program to

send to FDA a letter of interest. FDA

requests that the letters of interest from

the retail food establishments provide

information concerning the nature of

their menu, the location and size of

their facility, the type of techniques they

use to prepare their products, the extent

to which, and how, they employ

HACCP; identify area government

officials with whom they have worked

to implement or reinforce the system;

identify which government officials

they would like involved in the pilot

program; and identify trade associations

they would like involved with them in

the pilot. FDA will consider these

factors in reviewing the letters of

interest from retail applicants as a basis

for identifying a limited number of

individual establishments that, in the

judgment of the agency, are best suited

to participate in the program. The

agency will request selected retail pilot

participants to maintain their food

safety program based upon HACCP

principles for the duration of the pilot.

FDA will study the information and

data the pilot participants use to

maintain their food safety program.

FDA estimates the burdens of this

collection of the information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Activity No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

Letters of interest from State/local/tribal authorities2 50 1 50 1 50

Letters from interested retail firms2 50 1 50 1 50

Total 100

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

2One time activity.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN1

Activity No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

Plan development 50 1 50 100 5,000

Plan implement documentation 50 7,000 350,000 .05 17,500

Implementation review 50 4 200 4 800

Total 23,300

1There are no operating and maintenance costs or capital costs associated with this collection of information.
40718 Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Notices

FDA estimates the burden incurred by

interested regulatory agencies and retail

industry to provide FDA with a letter of

interest to be a one time burden. FDA

estimates the burden of collecting and

maintaining food safety information

based upon HACCP principles during

the pilot program will vary considerably

across the wide spectrum of retail

activities and establishments and the

type and number of products involved,

and the nature of the equipment or

instruments required by the retail

establishment for monitoring. The

estimated burden by the retail industry

for maintaining their food safety system

would involve the development, if not

already implemented, and maintenance

of the food safety plan based upon

HACCP principles, the implementation

and records generated by that plan, and

the verification of the plan’s

implementation activities and records.

These estimates are based on FDA’s

experience with other government pilot

programs and with comments received

through the conference of food

protection, public meetings, and retail

industry advice. This information was

utilized to design the pilot program with

the least amount of burden to the retail

industry.

Dated: July 22, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20309 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98N–0194]

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 August 31,

1998.

ADDRESSES: Submit written comments

on the collection of information to the

Office of Information and Regulatory

Affairs, OMB, New Executive Office

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

Washington, DC 20503, Attn: Desk

Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Margaret R. Schlosburg, 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.

Registration of Cosmetic Product

Establishment—21 CFR Part 710 (OMB

Control Number 0910–0027—Extension)

Under the Federal Food, Drug, and

Cosmetic Act (the act), cosmetic

products that are adulterated under

section 601 of the act (21 U.S.C. 361) or

misbranded under section 602 of the act

(21 U.S.C. 362) may not be distributed

in interstate commerce. To assist FDA in

carrying out its responsibility to regulate

cosmetics, FDA requests that

establishments that manufacture or

package cosmetic products register with

the agency on Form FDA 2511 entitled

‘‘Registration of Cosmetic Product

Establishment.’’ Regulations providing

procedures for the voluntary registration

of cosmetic product establishments are

found in 21 CFR part 710.

Since mandatory registration of

cosmetic establishments is not

authorized by statute, voluntary

registration provides FDA with the best

information available about the location,

business trading names used, and the

type of activity (manufacturing or

packaging) of cosmetic product

establishments that participate in this

program. In addition, the registration

information is an essential part of

planning onsite inspections to

determine the scope and extent of

noncompliance with applicable

provisions of the act. The registration

information is used to estimate the size

of the cosmetic industry regulated.

Registration is permanent, although

FDA requests that firms submit an

amended registration on Form FDA

2511 if any of the information originally

submitted changes.

FDA uses registration information as

input for a computer data base of

cosmetic product establishments. This

data base is used for mailing lists to

distribute regulatory information or to

invite firms to participate in workshops

on topics in which they may be

interested. FDA estimates the burden of

this collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Part Form No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

710 FDA 2511 50 1 50 0.4 20

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