Federal Register / Vol. 66, No. 28 / Friday, February 9, 2001 / Notices 9709

TABLE 4.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (NONREGISTERED) 1, 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual Records Hours per

Recordkeeper Total Hours

225.142 45,000 4 180,000 1 180,000

225.158 45,000 1 45,000 4 180,000

225.180 45,000 32 1,440,000 .12 172,800

225.202 45,000 260 11,700,000 .33 3,861,000

Total 4,393,800

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

2 Unlicensed mixer-feeders.

The estimate of the times required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

finally calculate the total burden hours

(i.e., number of recordkeepers, number

of medicated feeds being manufactured,

etc.) is derived from agency records and

experience.

Dated: February 5, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3416 Filed 2–8–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1567]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Registration of Producers of Drugs

and Listing of Drugs in Commercial

Distribution

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.

DATES: Submit written comments on the

collection of information by March 12,

2001.

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: Wendy

Taylor, Desk Officer for FDA.

FOR FURTHER INFORMATION CONTACT:

Karen L. Nelson, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1482.

SUPPLEMENTARY INFORMATION: In

compliance with 44 U.S.C. 3507, FDA

has submitted the following proposed

collection of information to OMB for

review and clearance.

Registration of Producers of Drugs and

Listing of Drugs in Commercial

Distribution—21 CFR Part 207 (OMB

Control No. 0910–0045)—Extension

Under section 510 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 360), FDA is authorized to

establish a system for registration of

producers of drugs and for listing of

drugs in commercial distribution. To

implement section 510 of the act, FDA

issued part 207 (21 CFR part 207).

Under § 207.20, manufacturers,

repackers, and relabelers that engage in

the manufacture, preparation,

propagation, compounding, or

processing of human or veterinary drugs

and biological products, including bulk

drug substances and bulk drug

substances for prescription

compounding, and drug premixes as

well as finished dosage forms, whether

prescription or over-the-counter, are

required to register their establishment.

In addition, manufacturers, repackers,

and relabelers are required to submit a

listing of every drug or biological

product in commercial distribution.

Owners or operators of establishments

that distribute, under their own label or

trade name, a drug product

manufactured by a registered

establishment are not required either to

register or list. However, distributors

may elect to submit drug listing

information in lieu of the registered

establishment that manufactures the

drug product. Foreign drug

establishments must also comply with

the establishment registration and

product listing requirements if they

import or offer for import their products

into the United States.

Under §§ 207.21 and 207.22,

establishments must register with FDA

by submitting Form FDA 2656

(Registration of Drug Establishment)

within 5 days after beginning the

manufacture of drugs or biologicals, or

within 5 days after the submission of a

drug application or biological license

application. In addition, establishments

must register annually by returning,

within 30 days of receipt from FDA,

Form FDA 2656e (Annual Update of

Drug Establishment). Changes in

individual ownership, corporate or

partnership structure location, or drughandling activity must be submitted as

amendments to registration under

§ 207.26 within 5 days of such changes.

Distributors that elect to submit drug

listing information must submit Form

FDA 2656 to FDA and a copy of the

completed form to the registered

establishment that manufactured the

product to obtain a labeler code.

Establishments must, within 5 days of

beginning the manufacture of drugs or

biologicals, submit to FDA a listing for

every drug or biological product in

commercial distribution at that time by

using Form FDA 2657 (Drug Product

Listing). Private label distributors may

elect to submit to FDA a listing of every

drug product they place in commercial

distribution. Registered establishments

must submit to FDA drug product

listing for those private label

distributors who do not elect to submit

listing information by using Form FDA

2658 (Registered Establishments’ Report

of Private Label Distributors).

Under § 207.25, product listing

information submitted to FDA must,

depending on the type of product being

listed, include any new drug application

number or biological establishment

license number, copies of current

labeling and a sampling of

advertisements, a quantitative listing of

the active ingredient for each drug or

biological product not subject to an

approved application or license, the

National Drug Code number, and any

drug imprinting information.

9710 Federal Register / Vol. 66, No. 28 / Friday, February 9, 2001 / Notices

In addition to the product listing

information required on Form FDA

2657, FDA may also require, under

§ 207.31, a copy of all advertisements

and a quantitative listing of all

ingredients for each listed drug or

biological product not subject to an

approved application or license; the

basis for a determination, by the

establishment, that a listed drug or

biological product is not subject to

marketing or licensing approval

requirements; and a list of certain drugs

or biological products containing a

particular ingredient. FDA may also

request, but not require, the submission

of a qualitative listing of the inactive

ingredients for all listed drugs or

biological products, and a quantitative

listing of the active ingredients for all

listed drugs or biological products

subject to an approved application or

license.

Under § 207.30, establishments must

update their product listing information

by using Form FDA 2657 and/or Form

FDA 2658 every June and December or,

at the discretion of the establishment,

when any change occurs. These updates

must include the following information:

(1) A listing of all drug or biological

products introduced for commercial

distribution that have not been included

in any previously submitted list, (2) all

drug or biological products formerly

listed for which commercial distribution

has been discontinued, (3) all drug or

biological products for which a notice of

discontinuance was submitted and for

which commercial distribution has been

resumed, and (4) any material change in

any information previously submitted.

No update is required if no changes

have occurred since the previously

submitted list.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

Reporting No. of

Respondents

No. of

Respones per

Respondent

Annual

Frequency

per Response

Total Annual

Responses

Hours per

Response

(1) Form FDA–2656 Registration of Drug Establishment

21 CFR 207.21, 207.22, 207.25, 207.26, and 207.40 15,802 .34 5,438 .5 2,719

(2) Form FDA–2656e Annual Update of Drug Establishment

21 CFR 207.21, 207.22, 207.25, 207.26, and 207.40 7,226 1 7,226 .5 3,613

(3) Form FDA–2657 Drug Product Listing

21 CFR 207.21, 207.22, 207.25, 207.30, 207.31,

and 207.40 14,381 2.80 40,270 .5 20,135

(4) Form FDA–2658 Registered Establishments’ Report of Private Label Distributors

21 CFR 207.21, 207.22, 207.25, 207.30, and 207.31 6,221 2.14 13,289 .5 6,645

Total Reporting Burden 33,112

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

In the Federal Register of November

2, 2000 (65 FR 65858), the agency

requested comments on the proposed

collections of information. The agency

received one comment on the 60-day

notice. The comment recommended that

FDA eliminate the requirement to send

a representative label and/or carton with

each Form FDA 2657 and 2658, and

that, instead, the labeling would be

available and submitted to FDA upon

request.

FDA appreciates the recommendation

concerning labeling submissions.

However, the comment is beyond the

scope of the November 2, 2000, notice.

That notice provided an opportunity for

public comment on the agency’s

estimates of the burden resulting from

the information collection requirements

imposed by part 207. In the Federal

Register of November 30, 2000 (65 FR

73798), FDA announced as part of the

semiannual regulatory agenda that it

intends to publish a proposed rule to

revise part 207 to clarify the

requirements for registration and listing

and to consolidate and reorganize the

regulations. The proposal would also

require the electronic submission of

establishment registration and product

listing information. It would be more

appropriate to submit the comment to

that proposed rule after it publishes in

the Federal Register.

Dated: February 5, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3414 Filed 2–8–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1685]

New Food Chemicals Codex

Monographs, Revisions of Certain

Food Chemicals Codex Monographs, a

New General Test Procedure, and

Revisions to a Policy; Opportunity for

Public Comment; Correction

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice; correction.

SUMMARY: The Food and Drug

Administration (FDA) is correcting a

notice document that published in the

Federal Register of January 22, 2001 (66

FR 6624). The notice announced an

opportunity for public comment on

proposed new Food Chemicals Codex

specification monographs, proposed

changes to certain Food Chemicals

Codex specification monographs, a

proposed new general test procedure,

and proposed changes to a policy in the

fourth edition. The notice was

published with some inadvertent errors.

This document corrects those errors.

DATES: Submit written comments by

March 8, 2001. (The committee advises

that comments received after this date

may not be considered for the third

supplement to the fourth edition.

Comments received too late for

consideration for the third supplement

will be considered for later supplements

or for a new edition of the Food

Chemicals Codex.)

FOR FURTHER INFORMATION CONTACT: Paul

M. Kuznesof, Division of Product

Manufacture and Use (HFS–246), Office

of Premarket Approval, Center for Food

Safety and Applied Nutrition, Food and

Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3009.