Federal Register / Vol. 66, No. 28 / Friday, February 9, 2001 / Notices 9707

required to establish, maintain, and

retain records for Type A medicated

articles, including records to document

procedures required under the

manufacturing process to assure that

proper quality control is maintained.

Such records would, for example,

contain information concerning receipt

and inventory of drug components,

batch production, laboratory assay

results (i.e., batch and stability testing),

and product distribution. This

information is needed so that FDA can

monitor drug usage and possible

misformulation of Type A medicated

articles. The information could also

prove useful to FDA in investigating

product defects when a drug is recalled.

In addition, FDA will use the CGMP

criteria in part 226 to determine

whether or not the systems used by

manufacturers of Type A medicated

articles are adequate to assure that their

medicated articles meet the

requirements of the act as to safety and

also meet the articles, claimed identity,

strength, quality, and purity, as required

by section 501(a)(2)(B) of the act as to

safety and also meet the articles,

claimed identity, strength, quality, and

purity, as required by section

501(a)(2)(B) of the act.

The respondents for Type A

medicated articles are pharmaceutical

firms that manufacture both human and

veterinary drugs, those firms that

produce only veterinary drugs and

commercial feed mills.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

226.42 115 260 29,900 0.75 22,425

226.58 115 260 29,900 1.75 52,325

226.80 115 260 29,900 0.75 52,325

226.102 115 260 29,900 1.75 52,325

226.110 115 260 29,900 0.25 7,475

226.115 115 10 1,150 0.5 575

Total 187,450

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

The estimate of the time required for

record preparation and maintenance is

based on agency communications with

industry. Other information needed to

calculate the total burden hours (i.e.,

manufacturing sites, number of Type A

medicated articles being manufactured,

etc.) are derived from agency records

and experience.

Dated: February 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–3348 Filed 2–8–01; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0046]

Agency Information Collection

Activities; Proposed Collection;

Comment Request; Current Good

Manufacturing Practice Regulations for

Medicated Feeds

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

the recordkeeping requirements for

manufacturers of medicated animal

feeds.

DATES: Submit written or electronic

comments on the collection of

information by April 10, 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:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1462.

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 reinstatement

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.

9708 Federal Register / Vol. 66, No. 28 / Friday, February 9, 2001 / Notices

Current Good Manufacturing Practice

Regulations for Medicated Feeds—21

CFR Part 225 (OMB Control No. 0910–

0152)—Extension

Under section 501 of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 351), FDA has the statutory

authority to issue current good

manufacturing practice (CGMP)

regulations for drugs, including

medicated feeds. Medicated feeds are

administered to animals for the

prevention, cure, mitigation, or

treatment of disease or growth

promotion and feed efficiency. Statutory

requirements for CGMP’s have been

codified under part 225 (21 CFR part

225). Medicated feeds which are not

manufactured in accordance with these

regulations are considered adulterated

under section 501(a)(2)(B) of the act.

Under part 225, a manufacturer is

required to establish, maintain, and

retain records for a medicated feed,

including records to document

procedures required during the

manufacturing process to assure that

proper quality control is maintained.

Such records would, for example,

contain information concerning receipt

and inventory of drug components,

batch production, laboratory assay

results (i.e. batch and stability testing),

labels , and product distribution.

This information is needed so that

FDA can monitor drug usage and

possible misformulation of medicated

feeds, to investigate violative drug

residues in products from treated

animals and investigate product defects

when a drug is recalled. In addition,

FDA will use the CGMP criteria in part

225 to determine whether or not the

systems and procedures used by

manufacturers of medicated feeds are

adequate to assure that their feeds meet

the requirements of the act as to safety

and also meet their claimed identity,

strength, quality, and purity, as required

by section 501(a)(2)(B) of the act.

A license is required when the

manufacturer of a medicated feed

involves the use of a drug or drugs,

which FDA has determined requires

more control because of the need for a

withdrawal period before slaughter or

carcinogenic concerns. Conversely, for

those medicated feeds for which FDA

has determined that the drugs used in

their manufacture need less control, a

license is not required and the

recordkeeping requirements are less

demanding. Respondents to this

collection of information are

commercial feed mills and mixerfeeders.

TABLE 1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSE HOLDERS) 1, 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.42(b)(5) through (b)(8) 1,150 260 299,000 1 299,000

225.58(c) and (d) 1,150 45 51,750 .5 25,875

225.80(b)(2) 1,150 1,600 1,840,000 .12 220,800

225.102(b)(1) 1,150 7,800 8,970,000 .08 717,600

225.110(b)(1) and (b)(2) 1,150 7,800 8,970,000 .015 134,550

225.115(b)(1) and (b)(2) 1,150 5 5,750 .12 690

Total 1,398,515

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

2 Commercial feed mills.

TABLE 2.—ESTIMATED ANNUAL RECORDKEEPING BURDEN (REGISTERED LICENSE HOLDERS) 1, 2

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Recordkeeping

Total Annual

Records

Hours per

Recordkeeper Total Hours

225.42(b)(5) through (b)(8) 100 260 26,000 .15 3,900

225.58(c) and (d) 100 36 3,600 .5 1,800

225.80(b)(2) 100 48 4,800 .12 576

225.102(b)(1) through (b)(5) 100 260 26,000 .4 10,400

Total 16,676

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

2 Licensed mixer-feeders.

TABLE 3.—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 8,000 4 32,000 1 32,000

225.158 8,000 1 8,000 4 32,000

225.180 8,000 96 768,000 .12 92,160

225.202 8,000 260 2,080,000 .65 1,352,000

Total 1,508,160

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

2 Unlicensed commercial feed mills.

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.