Federal Register / Vol. 63, No. 110 /Tuesday, June 9, 1998 / Notices 31503

strategy and a contact official; notifying

direct accounts of the recall and to

provide recipients with a ready means

of reporting to the recalling firm;

provide periodic status reports so FDA

can assess the progress of the recall. The

recall provisions provide the

information necessary for FDA to

monitor recalls and assess the adequacy

of a firm’s efforts in a recall. It also

permits FDA to evaluate whether a

recall has been completed in a manner

which assures that unreasonable risk of

substantial harm to the public health

has been eliminated. The guidelines

apply to all regulated products (i.e.,

food, including animal feed; drugs,

including animal drugs; medical

devices, cosmetics; and biological

products intended for human use.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

21 CFR Section No. of

Respondents

Annual

Frequency per

Response

Total Annual

Responses

Hours per

Response Total Hours

7.42 1,712 4 6,848 1.8 12,326

7.46 and 7.49 1,712 4 6,848 4 27,392

7.53 1,712 4 6,848 36 246,528

7.55(b) 1,712 4 6,848 2 13,696

Total 299,942

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

Dated: June 3, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15339 Filed 6–8–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0424]

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 July 9,

1998.

ADDRESSES: Submit written comments

on the collection of information to

Office of Information and Regulatory

Affairs, OMB, New Executive Office

Bldg., 725 17th St. NW., rm. 10235,

Washington, DC 20503, Attention: 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 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.

Transmittal of Advertisements and

Promotional Labeling for Drugs and

Biologics for Human Use (Form FDA

2253)

Under § 314.81(b)(3)(i) (21 CFR

314.81(b)(3)(i)), sponsors of approved

applications for marketed prescription

drugs and antibiotic drugs for human

use are required to submit specimens of

promotional labeling and

advertisements at the time of initial

dissemination of the labeling and at the

time of initial publication of the

advertisements. Each submission is

required to be accompanied by a

completed transmittal Form FDA 2253

(Transmittal of Advertisements and

Promotional Labeling for Drugs for

Human Use). Statutory authority for the

collection of this information is

provided by sections 505(a), (b), (j), and

(k), 507(g), and 701(a) of the Federal

Food, Drug, and Cosmetic Act (the act)

(21 U.S.C. 355(a), (b), (j), and (k), 357

(g), and 371(a)).

Similarly, under § 601.12(f)(4) (21

CFR 601.12(f)(4)) (62 FR 39890, July 24,

1997; effective October 7, 1997),

manufacturers of licensed biological

products are required to submit

specimens of advertising and

promotional labeling to FDA in

accordance with § 314.81(b)(3)(i).

Statutory authority for the collection of

this information is provided by section

351 of the Public Health Service Act (42

U.S.C. 262), which gives FDA the

responsibility to prescribe standards

designed to ensure the safety, purity,

potency, and effectiveness of biological

products. In furtherance of this

responsibility, FDA regulates

advertising and labeling for biological

products. Currently, specimens of

advertising and promotional labeling are

submitted to FDA with Form FDA 2567,

a two-part transmittal form that is also

used to transmit other forms of labeling

(e.g., circulars, package labels, and

container labels) for FDA review when

a firm is requesting premarket approval

of a product or proposing changes to

product carton or container labeling.

FDA is revising Form FDA 2253 to

enable it to be used to transmit

specimens of promotional labeling and

advertisements for biological products

as well as for prescription drugs and

antibiotics. The proposed revised form

has the following major changes:

1. The revised, harmonized form will

be used by sponsors of approved

applications for marketed prescription

drugs and antibiotic drugs regulated by

the Center for Drug Evaluation and

Research (CDER) who must submit

specimens of advertisements and

promotional labeling to the agency, and

may be used by manufacturers of

licensed biological products regulated

by the Center for Biologics Evaluation

and Research (CBER) who submit draft

and/or final copies of promotional

labeling and advertisements to the

agency. Revising and harmonizing Form

FDA 2253 will eliminate the need for

sponsors to use two different forms to

transmit similar materials for

submission to the agency; however,

manufacturers of biological products

may continue to use Form FDA 2567 to

transmit advertisements and

promotional labeling if they wish. The

other uses of Form FDA 2567 will

remain unchanged.

2. The revised, harmonized form

updates the information about the types
31504 Federal Register / Vol. 63, No. 110 /Tuesday, June 9, 1998 / Notices

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.

3. Currently, when more than one

prescription drug product is promoted

in the promotional labeling or in an

advertisement, sponsors submit

specimens of the promotional labeling

or advertisement to the approved

application for each product promoted

in the promotional labeling or

advertisement. The revised form,

provides for sponsors to submit

specimens of multi-product promotional

labeling and advertisements to only two

files; to the approved product

application most frequently promoted,

and to a company name file. This multiproduct submission should crossreference the other approved

applications. The agency anticipates

that the proposed revised form and

revised submission will save sponsors

time and money by eliminating the need

for making multiple submissions and for

maintaining dual inventories of both

forms and multiple processing

capabilities.

Under Executive Order 12866, FDA

published a notice in the Federal

Register of October 24, 1997 (62 FR

55408 through 55409), that announced

an opportunity for public comment on

a proposed revision of Form FDA 2253.

Based on the five responses to FDA’s

proposal to streamline the submission of

promotional labeling and

advertisements via Form FDA 2253,

none of the respondents objected to the

agency revising the form, and two

respondents had very favorable

comments regarding the initiative to

revise the form and streamline the

submission process for multiple product

submissions.

One respondent stated that it was

unclear whose burden had been

measured for the estimate and stated

that information about methodology and

assumptions was insufficient for it to

comment. The agency noted in the

October 24, 1997, notice that its

estimate was based on contacts with

industry representatives. The agency’s

estimate of 2 hours per response,

including time for reviewing

instructions, searching existing data

sources, gathering and maintaining the

data needed, and completing and

reviewing the collection of information,

was obtained from an informal survey of

current respondents who were asked

how long it took them to prepare and

submit data and materials intended to

accompany Form FDA 2253. The

comment did not provide an alternative

estimate for the proposed burden hours.

The agency’s estimate, thus, will remain

the same. No other comment provided

an alternative estimate.

Several respondents commented on

the physical layout of the form and

suggested that some parts of the form be

made larger or smaller. The agency

agrees with some of these suggestions

and will modify the layout of the form.

In the section of the form that describes

various submitted promotional items,

some respondents suggested different

descriptions for types of promotional

materials (such as replace the proposed

term ‘‘profession journal ad’’ with

‘‘profession print advertisements’’), and

suggested combining various similar

types of materials with the addition and

deletion of specific promotional items.

The agency agrees that the consolidation

of material types will make the form

easier to understand and plans to make

these modifications.

Two respondents questioned whether

it was necessary to identify the

submission preparer, and whether it

was necessary for the ‘‘responsible

official’’ to actually sign the form. The

agency agrees that it is not necessary to

know who prepared the submission,

because agency inquiries will be

directed to the ‘‘responsible official’’

(contact person) either by telephone or

by written correspondence. The agency

considers that it would be helpful to

have the ‘‘responsible official’’ sign the

form to assure that the actual

submission was seen or reviewed by the

contact person.

One respondent commented on

whether the revised Form FDA 2253

should accompany draft promotional

materials intended for CBER for

promoting a biologic. The respondent

suggested that the revised form created

an artificial distinction between drugs

and biologics by requiring that draft

biologic promotional materials

submitted for voluntary preclearance

continue to be accompanied by a form

(now Form FDA 2253 in place of Form

FDA 2567) because CDER does not use

a form to accompany draft promotional

materials. Thus, the respondent

considered use of the form to be

unnecessary for voluntary submissions.

CBER notes that some sponsors have

submitted proposed promotional

materials to CBER for comment without

the Form FDA 2567, and that this has

been, and continues to be, an acceptable

method of submitting draft promotional

materials. However, from past

experience, CBER considers that the use

of the Form FDA 2567 to accompany

draft promotional materials makes

tracking and followup of the materials

more efficient and more timely. For

example, the form provides a quick and

efficient way of providing comments to

sponsors without the need for a formal

letter which would require more time.

CBER also wants to emphasize that the

option of using Form FDA 2253 or 2567

to accompany draft promotional

materials to CBER does in no way

mandate or obligate drug sponsors to

use a form when submitting proposed

promotional materials to CDER for

comment.

Another respondent asked for

clarification regarding the biologic

license application (BLA) number

referenced in number 3. The respondent

stated that the form provided for the

sponsor to identify the BLA number for

biologics, but that the BLA number for

the original application becomes

obsolete upon approval. Later

supplements are assigned new BLA

numbers, and a sponsor can have

multiple submissions under review at

the same time, each with a different

number. Therefore, the respondent

requested clarification of which number

would be appropriate to list in number

3. The agency agrees that further

clarification of number 3 is required. We

believe the least confusing and most

efficient way to reference the BLA

number would be for sponsors to

include the ‘‘most recent reference

number’’ for an application concerning

a labeling change.

Four of the five respondents requested

further explanation regarding the

multiple submissions procedures. The

agency will clearly explain the

procedures regarding multiple

submissions on the form, and how to

submit multiple drug product

promotional materials. Additionally,

one respondent asked whether the

‘‘company named file’’ will be

releasable under the Freedom of

Information Act (FOIA). Currently,

CDER’s Division of Drug Marketing,

Advertising, and Communications

(DDMAC) maintains two types of files

related to promotional materials. One

file contains promotional materials

submitted under the postmarketing

requirements of § 314.81. These

promotional materials have been

submitted to the agency because they

were already publicly disseminated.

The agency would consider this

information releasable under FOIA. The

‘‘company named file’’ for multiple

submissions of Form FDA 2253-related

materials would be this type of file. The

other types of materials maintained by

DDMAC are related to: (1) Advisory

opinions (generally on proposed

promotional materials) which are not
Federal Register / Vol. 63, No. 110 /Tuesday, June 9, 1998 / Notices 31505

releasable, and (2) enforcement actions

which are releasable.

Three respondents were not clear

whether approved product labeling was

still required to accompany promotional

materials, and one respondent proposed

an alternative method of submitting

labeling. The agency presently requests

that sponsors submit two copies of the

approved product labeling for each

referenced drug product. This has been

clarified on the form. Alternative

methods of submitting approved

product labeling may be considered at a

later time.

Three respondents proposed that the

agency provide the revised Form FDA

2253 in electronic form, and accept

some promotional materials via

electronic means. The agency currently

provides many forms on the Internet

using the World Wide Web (WWW) at

‘‘http://www.fda.gov/opacom/

morechoices/fdaforms/fdaforms.html’’

and intends to add the revised Form

FDA 2253 shortly after it is an approved

form. As for the submission of

promotional materials by electronic

means, DDMAC is currently reviewing a

pilot project where proposed

promotional materials are submitted for

review via CD–ROM and in hard copy.

If successful, DDMAC plans to continue

the pilot project and refine the means of

submitting promotional materials by

electronic means.

FDA estimates the burden of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1

Form No. of

Respondents

Total Annual

Responses

Hours per

Response

Total Estimated

Hours

FDA 2253 612 12,379 2 24,758

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

In fiscal year 1995, CDER received

10,879 submissions of advertising and

promotional labeling under Form FDA

2253 from an estimated 512

manufacturers. In the same period of

time, CBER received 1, 034 submissions

from 57 manufacturers that could have

made use of revised Form FDA 2253.

Prior to October 7, 1997, the submission

of advertising and promotional labeling

to CBER using Form FDA 2567 was a

voluntary procedure. Under

§ 601.12(f)(4) (62 FR 39890),

manufacturers of licensed biological

products are required to submit

specimens of advertising and

promotional labeling to FDA in

accordance with § 314.81(b)(3)(i), FDA

estimates that under the new regulation

CBER will receive over 1,500

submissions from approximately 100

manufacturers that may use the revised

Form FDA 2253. Thus, FDA estimates

that there may be 12,379 submissions of

advertising and promotional labeling to

FDA under revised Form FDA 2253.

Based on contacts with industry

representatives, FDA estimates that 2

hours would be required for an industry

regulatory affairs specialist to fill out the

proposed form, collate the

documentation, and send the

submission to CDER or CBER.

Manufacturers of biological products

may use the revised Form FDA 2253 or

may continue to use Form FDA 2567 for

the submission of advertisements and

promotional labeling to CBER.

Dated: June 2, 1998.

William K. Hubbard,

Associate Commissioner for Policy

Coordination.

[FR Doc. 98–15192 Filed 6–8–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97N–0503]

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 July 9,

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, Attention: 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 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.

New Animal Drug Application (NADA),

Form FDA 356 V, 21 CFR Part 514—

(OMB Control Number 0910–0032—

Reinstatement)

Under the Federal Food, Drug, and

Cosmetic Act (the act), FDA has the

responsibility for the approval of new

animal drugs that are safe and effective.

Section 512(b) of the act (21 U.S.C.

360b(b)), requires that a sponsor submit

and receive approval of a NADA before

interstate marketing is allowed. The

regulations implementing statutory

requirements for NADA approval have

been codified under 21 CFR part 514.

NADA applicants generally use a single

form, FDA 356 V. The NADA must

contain, among other things, safety and

effectiveness data for the drug, labeling,

a list of components, manufacturing and

controls information, and complete

information on any methods used to

determine residues of drug chemicals in

edible tissues. While the NADA is

pending, an amended application may

be submitted for proposed changes.

After a NADA has been approved, a

supplemental application must be

submitted for certain proposed changes,

including changes beyond the variations

provided for in the NADA and other

labeling changes. An amended

application and a supplemental

application may omit statements

concerning which no change is

proposed. This information is reviewed

by FDA scientific personnel to ensure

that the intended use of an animal drug,

whether as a pharmaceutical dosage

form, in drinking water, or in medicated

feed is safe and effective. The

respondents are pharmaceutical firms

that produce veterinary products and

commercial feed mills.

FDA estimates the burden for this

collection of information as follows: