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.
Federal Register / Vol. 63, No. 146 /Thursday, July 30, 1998 / Notices 40719

The burden estimates are based on

past experience and on discussions with

registrants during routine

communications. FDA receives an

average of 50 registration submissions

annually. There has been no change

over the past 13 years in the number of

submissions of Form FDA 2511 or in the

time it takes to complete this form.

Dated: July 23, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20302 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket Nos. 98D–0264, 98D–0265, et al.]

Food and Drug Administration

Modernization Act of 1997;

Establishment of Public Dockets

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that it is establishing a series of public

dockets containing information on the

implementation of the Food and Drug

Administration Modernization Act of

1997 (Modernization Act). This action is

intended to ensure that information

submitted to FDA on the

implementation of the Modernization

Act is available to all interested persons

in a timely fashion.

ADDRESSES: The public dockets are

located in the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. The public

dockets may be accessed directly under

the docket numbers provided in the list

below, and they are also posted on the

agency’s Internet World Wide Web

(WWW) site at ‘‘http://www.fda.gov/

ohrms/dockets’’.

FOR FURTHER INFORMATION CONTACT:

Nancy E. Derr, Center for Drug

Evaluation and Research (HFD–5),

Food and Drug Administration,

5600 Fishers Lane, Rockville, MD

20857, 301–594–5400;

Stephen M. Ripley, Center for

Biologics Evaluation and Research

(HFM–17), Food and Drug

Administration, 1401 Rockville

Pike, Rockville, MD 20852, 301–

827–6210;

Joseph M. Sheehan, Center for

Devices and Radiological Health

(HFZ–215), Food and Drug

Administration, 1350 Piccard Dr.,

Rockville, MD 20850, 301–827–

2974; or

George A. Mitchell, Center for

Veterinary Medicine (HFV–6), Food

and Drug Administration, 7500

Standish Pl., Rockville, MD 20855,

301–827–5587.

SUPPLEMENTARY INFORMATION: On

November 21, 1997, the President

signed the Modernization Act into law

(Pub. L. 105–115). The Modernization

Act provides for the reauthorization of

the Prescription Drug User Fee Act of

1992, codifies many FDA initiatives

undertaken in recent years under the

Administration’s Reinventing

Government Program, and implements

certain other reforms of FDA processes.

FDA has received numerous

recommendations on how the agency

should implement various

Modernization Act provisions for which

dockets have not yet been established.

To provide timely public access to these

recommendations, FDA is establishing a

series of public dockets through which

interested persons can have access to

these recommendations and other

information submitted to FDA. Each

docket contains information pertaining

to a specific section of the

Modernization Act and may be accessed

directly under the docket numbers

provided in the list below. FDA

expects to place submissions containing

recommendations on how the agency

should implement the Modernization

Act in one of these public dockets, or in

a new docket created for the specific

provision addressed in the

recommendations. These dockets are in

addition to those already established in

connection with implementation of

other provisions of the Modernization

Act, i.e., dockets assigned to the

Modernization Act-related notices,

guidances, or rules.

The following is a list of dockets that

FDA is establishing at this time to

provide access to information submitted

relating to the implementation of

specific provisions of the Modernization

Act. The list includes the section

number of the Modernization Act, the

title of the docket, and the docket

number.

Section No. Docket Title Docket No.

111 Pediatric Studies of Drugs 98D–0265

112 Fast Track Products 98D–0267

113 NIH Data Bank—Clinical Trials for Serious Diseases 98D–0293

114 Health Care Economic Information 98D–0468

118 Data Requirements for Drugs and Biologics 98D–0264

121 Positron Emission Tomography (PET) 98D–0266

122 Radiopharmaceuticals 98D–0372

127 Pharmacy Compounding 98D–0272

216 Six-Year Use of Data 98D–0466

406 Agency Plan for Statutory Compliance 98N–0339

From time to time, FDA may establish

dockets on other Modernization Act

provisions but does not intend to

separately announce the creation of

such dockets. Instead, a list of the

Modernization Act dockets will be

maintained on the agency’s Internet

WWW site at ‘‘http//www.fda.gov/

ohrms/dockets’’. The dockets created in

connection with specific notices,

guidances, or rules published in the

Federal Register are also listed at this

site.

The public dockets are available for

public review in the Dockets

Management Branch (address above)

between 9 a.m. and 4 p.m., Monday

through Friday.

Dated: July 22, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–20307 Filed 7–29–98; 8:45 am]

BILLING CODE 4160–01–F