65858 Federal Register / Vol. 65, No. 213 / Thursday, November 2, 2000 / Notices

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1567]

Agency Information Collection

Activities; Proposed Collection;

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 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 governing the registration

of producers of drugs and listing of

drugs in commercial distribution.

DATES: Submit written or electronic

comments on the collection of

information by January 2, 2001.

ADDRESSES: Submit electronic

comments on the collection of

information to http://

www.accessdata.fda.gov/scripts/oc/

dockets/edockethome.cfm. 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:

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: 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,

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.

Registration of Producers of Drugs and

Listing of Drugs in Commercial

Distribution—21 CFR Part 207 (OMB

Control Number 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.

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

Federal Register / Vol. 65, No. 213 / Thursday, November 2, 2000 / Notices 65859

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

Form 21 CFR

Section

No. of

Respondents

No. of Responses

per Respondent

Total Annual

Responses

Hours per

Response Total Hours

Form FDA 2656—Registration of

Drug Establishment 207.21

207.22

207.25

207.26

207.40

15,802 .34 5,438 0.5 2,719

Form FDA 2656e—Annual Update

of Drug Establishment 207.21

207.22

207.25

207.26

207.40

7,226 1 7,226 0.5 3,613

Form FDA 2657—Drug Product

Listing 207.21

207.22

207.25

207.30

207.31

207.40

14,381 2.80 40,270 0.5 20,135

Form FDA 2658—Registered Establishments’ Report of Private

Label Distributors 207.21

207.22

207.25

207.30

207.31

6,221 2.14 13,289 0.5 6,645

Total 33,112

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

Dated: October 25, 2000.

Margaret M. Dotzel,

Associate Commissioner for Policy.

[FR Doc. 00–28135 Filed 11–01–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 98F–1192]

Troy Corp.; Withdrawal of Food

Additive Petition

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

withdrawal, without prejudice to a

future filing, of a food additive petition

(FAP 7B4546) proposing that the food

additive regulations be amended to

provide for the safe use of 3-iodo-2-

propynyl butyl carbamate as a

fungicidal additive for resinous and

polymeric coatings intended to contact

food.

FOR FURTHER INFORMATION CONTACT:

Mark A. Hepp, Center for Food Safety

and Applied Nutrition (HFS–215), Food

and Drug Administration, 200 C St. SW.,

Washington, DC 20204, 202–418–3098.

SUPPLEMENTARY INFORMATION: In a notice

published in the Federal Register of

December 24, 1998 (63 FR 71295), FDA

announced that a food additive petition

(FAP 7B4546) had been filed by Troy

Corp. c/o S.L. Graham & Associates,

1801 Peachtree Lane, Bowie, MD 20721.

The petition proposed to amend the

food additive regulations in § 175.300

Resinous and polymeric coatings (21

CFR 175.300) to provide for the safe use

of 3-iodo-2-propynyl butyl carbamate as

a fungicidal additive for resinous and

polymeric coatings intended to contact

food. Troy Corp. has now withdrawn

the petition without prejudice to a

future filing (21 CFR 171.7).