38290 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices

Dated: June 14, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–15432 Filed 6–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0726]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; General

Licensing Provisions: Changes to an

Approved Application, Labeling, and

Revocation and Suspension

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 July 20,

2000.

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:

JonnaLynn P. Capezzuto, Office of

Information Resources Management

(HFA–250), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–4659.

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.

General Licensing Provisions: Changes

to an Approved Application, Labeling,

and Revocation and Suspension (OMB

Control Number 0910–0315)—Extension

Under Section 351 of the Public

Health Services Act (PHS Act) (42

U.S.C. 262), manufacturers of biological

products must submit a license

application for FDA review and

approval prior to marketing a biological

product in interstate commerce.

Licenses may be issued only upon

showing that the establishment and the

products for which a license is desired

meet standards prescribed in regulations

designed to ensure the continued safety,

purity, and potency of such products.

All such licenses are issued, suspended,

and revoked as prescribed by

regulations.

In part 601 (21 CFR part 601),

§ 601.2(a) requires a manufacturer of a

biological product to submit an

application with accompanying

information, including labeling

information, to FDA for approval to

market a product in interstate

commerce. Section 601.12(b), (c), and

(d) requires applicants to follow specific

procedures in informing FDA of each

change, established in an approved

license application, in the product,

production process, quality controls,

equipment, facilities, or responsible

personnel depending on the potential

for the change to have a substantial,

moderate, minimal or no adverse effect

on the safety or effectiveness of the

product. Section 601.12(e) requires

applicants to submit a protocol, or

change to a protocol, as a supplement

requiring FDA approval prior to

distributing the product. Section

601.12(f)(1), (f)(2), and (f)(3) requires

applicants to follow specific procedures

in reporting labeling changes to FDA.

Section 601.12(f)(4) requires advertising

and promotional labeling and any

changes to be reported to FDA. Section

601.45 requires applicants to submit to

the agency for consideration, during the

preapproval review period, copies of all

promotional materials, including

promotional labeling as well as

advertisements. In addition to §§ 601.2

and 601.12, there are other regulations

that relate to certain information

submitted in a license application or

supplement as follows: Part 640 (21 CFR

part 640), specifically §§ 640.6, 640.17,

640.21(c), 640.22(c), 640.25(c),

640.56(c), 640.64(c), 640.74(a), and

(b)(2); 21 CFR 660.51(a)(4) and

680.1(b)(2)(iii) and (c). The burden

associated with the information

collection requirements in these

regulations is included in the burden

estimate for § 601.2, reported under

OMB Control No. 0910–0427, and

§ 601.12 in table 1 of this document.

Sections 600.15(b) and 610.53(d) require

the submission of a request for an

exemption or modification regarding the

temperature requirements during

shipment and from dating periods,

respectively, for certain biological

products. Section 601.25(b) requests

interested persons to submit, for review

and evaluation by an advisory review

panel, published and unpublished data

and information pertinent to a

designated category of biological

products that have been licensed prior

to July 1, 1972. Section 601.26(f)

requests that licensees submit to FDA a

written statement intended to show that

studies adequate and appropriate to

resolve questions raised about a

biological product have been

undertaken for a product if designated

as requiring further study under the

reclassification procedures. Section

601.5(a) requires a licensee to give

notice of its intention to discontinue

manufacture of a product or all

products. Section 601.6(a) requires the

licensee to notify selling agents and

distributors upon suspension of its

license, and provide FDA with records

of such notification.

Form FDA 2567 is used by

manufacturers of licensed biological

products to submit labeling (e.g.,

circulars, package labels, container

labels, etc.) and labeling changes for

FDA review and approval. The labeling

information is submitted with the form

for license applications, supplements, or

as part of an annual report. Form FDA

2567 is also used for the transmission of

advertisements and promotional

labeling. Form FDA 2567 serves as an

easy guide to assure that the

manufacturer has provided the

information required for expeditious

handling of their labeling by the Center

for Biologics Evaluation and Research

(CBER). For advertisements and

promotional labeling, manufacturers of

licensed biological products may submit

to CBER either Form FDA 2567 or 2253.

Form FDA 2253 was previously used

only by drug manufacturers regulated by

the Center for Drug Evaluation and

Research. In August of 1998, FDA

revised and harmonized Form FDA

2253 to enable the form to be used to

transmit specimens of promotional

labeling and advertisements for

biological products as well as for

prescription drugs and antibiotics. The

revised, harmonized form updates the

information about the types of

promotional materials and the codes

that are used to clarify the type of

advertisement or labeling submitted;

clarifies the intended audience for the

advertisements or promotional labeling

(e.g., consumers, professionals, news

services); and helps ensure that the

submission is complete.

The number of respondents is based

on the estimated annual number of

manufacturers that submitted the

required information to FDA. There are

an estimated 350 licensed biologics

manufacturers. However, not all

manufacturers will have any

submissions in a given year and some

may have multiple submissions. The

Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices 38291

total annual responses is based on the

estimated number of submissions (i.e.,

license applications, labeling and other

supplements, protocols, advertising and

promotional labeling, notifications)

received annually by FDA. The rate of

submissions are not expected to change

significantly in the next few years. The

hours per response are based on past

FDA experience with the various

submissions or notifications. Additional

information regarding these estimates is

provided below as necessary.

Under § 601.2(a), the total annual

responses is based on the numbers of

applications submitted to FDA for

approval to market a biological product.

The estimated burden hours include the

time required to fill out the form and

collate the documentation. The

estimated burden hours to prepare the

labeling information submitted with a

license application are included in the

burden hours to submit a license

application that are reported under

OMB Control No. 0910–0427.

Under § 601.12(f)(1), (f)(2), and (f)(3),

the estimated burden hours include the

time to prepare the supplement, fill out

the form, and collate the

documentation.

Under §§ 601.12(f)(4) and 601.45,

manufacturers of biological products

may use either Form FDA 2567 or Form

FDA 2253 to submit advertising and

promotional labeling. In fiscal year

1999, CBER received 3,784 submissions

of advertising and promotional labeling

from 114 manufacturers. FDA estimates

that approximately 55 percent of those

submissions were received with Form

FDA 2567 resulting in an estimated

2,081 submissions by 63 manufacturers.

The estimated burden hours include the

time to prepare the submission, fill out

the form, and collate the

documentation. The burden hours for

the remaining submissions received

using Form FDA 2253 are reported

under OMB Control No. 0910–0376.

Under §§ 601.12(b) through (d), and

601.12(e), the estimated burden hours

include the time to prepare the

appropriate supplement or protocol,

respectively, and collate the

documentation.

Under §§ 600.15(b) (21 CFR 600.15(b))

and 610.53(d), FDA receives very few

requests for an exemption or

modification to the requirements,

therefore, FDA has estimated one

respondent per year in table 1 of this

document to account for the rare

instance in which a request may be

made. The estimated burden hours

include the time to prepare the request

for modification or exemption.

Under § 601.25(b)(3), FDA estimates

no burden for this regulation because all

requested data and information had

been submitted by 1974. Under

§ 601.26(f), FDA estimates no burden for

this regulation because there are no

products designated to require further

study and none are predicted in the

future. However, based on the possible

reclassification of a product, the

labeling for the product may need to be

revised, or a manufacturer, on its own

initiative, may find further study

necessary. As a result, any changes to

product labeling would be reported

under § 601.12. The information

collection requirements for § 601.12 are

reported under OMB control number

0910–0315.

Under § 601.5(a), the total annual

responses are based on the estimated

annual number of notifications received

by FDA to discontinue either an

establishment and/or product license(s).

The estimated burden hours include the

time to prepare and submit a letter of

discontinuance.

Under § 601.6(a), the number of

respondents (21) is based on FDA

estimates that establishments would

need to notify an average of 20 selling

agents and distributors of such

suspension, and provide FDA with the

records of such notification. The

number of respondents is based on the

estimated annual number of

suspensions by FDA of an establishment

or product license(s). The estimated

burden hours includes the time to

prepare a notification letter and submit

record of such notification to FDA.

In the Federal Register of March 7,

2000 (65 FR 12011), the agency

requested comments on the proposed

collections of information. No

significant comments were received.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR section Form FDA No. No. of

respondents

Annual frequency

per response

Total annual

responses

Hours per

response Total hours

601.2(a) 2567 and 356h 2 17 3.71 63 2 126

601.12(f)(1) 2567 12 1 12 40 480

601.12(f)(2) 2567 10 1 10 20 200

601.12(f)(3) 2567 70 1.43 100 10 1,000

601.12(f)(4) and

601.45

2567 63 33.03 2,081 10 20,810

601.12(b)(1) and

(b)(3)

356h 2 190 4.75 903 80 72,240

601.12(c)(1) and

(c)(3)

356h 2 98 2.60 255 50 12,750

601.12(c)(5) 356h 2 34 1.21 41 50 2,050

601.12(d) 356h 2 166 1.37 227 10 2,270

601.12(e) 356h 2 14 1.43 20 20 400

600.15(b) 356h 2 111 88

610.53(d) 356h 2 111 88

601.25(b)(3) NA 0 0 0 0 0

601.26(f) NA 0 0 0 0 0

601.5(a) NA 33 1 33 .33 11

601.6(a) NA 2 10.50 21 .33 7

Total 112,360

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

2The burden hours for the use of Form FDA 356h are reported under OMB Control No. 0910–0427.

38292 Federal Register / Vol. 65, No. 119 / Tuesday, June 20, 2000 / Notices

Dated: June 14, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–15429 Filed 6–20–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–0505]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Substances Prohibited From Use in

Animal Food or Feed; Animal Protein

Prohibited in Ruminant Feed

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 July 20,

2000.

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:

Denver Presley, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1472.

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.

Title: Substances Prohibited From Use

in Animal Food or Feed; Animal

Proteins Prohibited in Ruminant Feed—

21 CFR Part 589—(OMB Control No.

0910–0339)—Extension

Description: This rule (§ 589.2000 (21

CFR 589.2000)) provides that protein

derived from mammalian tissue (with

some exceptions) for use in ruminant

feed is a food additive subject to section

409 of the Federal Food, Drug, and

Cosmetic Act (the act) (21 U.S.C. 348).

Proteins derived from animal tissues

contained in such feed ingredients in

distribution cannot be readily identified

(i.e., species), by recipients engaged in

the manufacture, processing and

distribution, and use of animal feeds

and feed ingredients.

Thus, under the agency’s authority in

section 701(a) of the act (21 U.S.C.

371(a)), to issue regulations for the

efficient enforcement of the act, this rule

places three general requirements on

persons that manufacture, blend,

process, distribute, or use products that

contain or may contain protein derived

from mammalian tissues and feeds

made from such products. The first

requirement is for cautionary labeling of

these products with direct language

developed by FDA. This labeling

requirement is exempt from the scope of

the PRA because it is a ‘‘public

disclosure of information originally

supplied by the Federal Government for

the purpose of disclosure to the public’’

(5 CFR 1329.3(c)(2)).

The second requirement is for

establishments to maintain and make

available to FDA, records that are

sufficient to track any material that

contains protein derived from

mammalian tissues (as defined in

§ 589.2000(a)(1)), throughout the

material’s receipt, processing, and

distribution. Based on available

information, FDA believes that

maintenance of these records is a usual

and customary part of normal business

practices for these firms. Therefore, this

recordkeeping requirement creates no

additional paperwork burden.

The third requirement is that

individuals or firms that manufacture,

blend, process, or distribute both

mammalian and nonmammalian

materials must maintain written

procedures to prevent commingling and

cross-contamination. An estimate of the

burden resulting from this

recordkeeping requirement is provided

in table 1 of this document. The

estimate is based on the time required

to develop written procedures.

Respondents to this collection of

information are individuals or firms that

manufacture, blend, process distribute,

or use feed or feed ingredients that

contain or may contain protein that may

be derived from mammalian tissue.

FDA estimates the burden of this

collection of information as follows:

TABLE1.—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

21 CFR Section No. of

Recordkeepers

Annual

Frequency per

Response

Total Annual

Records

Hours per

Record Total Hours

589.2000(e)(1)(iv) 1,030 1 1,030 14 14,420

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

The estimated number of respondents,

persons that separate mammalian and

nonmammalian materials, is derived

from inspections of firms handling

animal protein intended for use in

animal feed. The estimate of the time

required for this recordkeeping

requirement is based on agency records

and communication with industry.

Dated: June 14, 2000.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 00–15430 Filed 6–19–00; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

Biological Response Modifiers

Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

This notice announces a forthcoming

meeting of a public advisory committee

of the Food and Drug Administration