23264 Federal Register / Vol. 66, No. 89 / Tuesday, May 8, 2001 / Notices

response to Program Announcement: RFA

OH–01–008.

Contact Person for More Information:

Pervis C. Major, PhD., Scientific Review

Administrator, National Institute for

Occupational Safety and Health, CDC, 1095

Willowdale Road, M/S B228, Morgantown,

West Virginia 26505, telephone 304–285–

5979.

The Director, Management Analysis and

Services Office has been delegated the

authority to sign Federal Register notices

pertaining to announcements of meetings and

other committee management activities, for

both the Centers for Disease Control and

Prevention and the Agency for Toxic

Substances and Disease Registry.

Dated: April 20, 2001.

John C. Burckhardt,

Acting Director, Management Analysis and

Services Office, Centers for Disease Control

and Prevention (CDC).

[FR Doc. 01–11509 Filed 5–7–01; 8:45 am]

BILLING CODE 4163–19–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1599]

Agency Information Collection

Activities; Announcement of OMB

Approval; Use of Impact-Resistant

Lenses in Eyeglasses and Sunglasses

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘Use of Impact-Resistant Lenses in

Eyeglasses and Sunglasses’’ has been

approved by the Office of Management

and Budget (OMB) under the Paperwork

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Peggy Schlosburg, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1223.

SUPPLEMENTARY INFORMATION: In the

Federal Register of March 7, 2001 (66

FR 13769), the agency announced that

the proposed information collection had

been submitted to OMB for review and

clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0182. The

approval expires on April 30, 2004. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: May 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11451 Filed 5–7–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 96N–0393]

Agency Information Collection

Activities; Announcement of OMB

Approval; MedWatch: The FDA Medical

Products Reporting Program

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing

that a collection of information entitled

‘‘MedWatch: The FDA Medical Products

Reporting Program’’ has been approved

by the Office of Management and

Budget (OMB) under the Paperwork

Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT:

Mark L. Pincus, Office of Information

Resources Management (HFA–250),

Food and Drug Administration, 5600

Fishers Lane, Rockville, MD 20857,

301–827–1471.

SUPPLEMENTARY INFORMATION: In the

Federal Register of November 16, 2000

(65 FR 69314), the agency announced

that the proposed information collection

had been submitted to OMB for review

and clearance under 44 U.S.C. 3507. An

agency may not conduct or sponsor, and

a person is not required to respond to,

a collection of information unless it

displays a currently valid OMB control

number. OMB has now approved the

information collection and has assigned

OMB control number 0910–0291. The

approval expires on April 30, 2003. A

copy of the supporting statement for this

information collection is available on

the Internet at http://www.fda.gov/

ohrms/dockets.

Dated: May 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11453 Filed 5–7–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N–1637]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request;

Transmittal of Advertising and

Promotional Labeling for Drugs and

Biologics for Human Use

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 June 7,

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.

Transmittal of Advertising and

Promotional Labeling for Drugs and

Biologics for Human Use

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 and

Biologics for Human Use). Statutory

authority for the collection of this

information is provided by sections

505(a), (b), (j), and (k) and 701(a) of the

Federal Register / Vol. 66, No. 89 / Tuesday, May 8, 2001 / Notices 23265

Federal Food, Drug, and Cosmetic Act

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

371(a)). Similarly, under 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 by 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’s Center for Biologics

Evaluation and Research (CBER) with

either Form FDA 2253 or Form FDA

2567, which is a two-part transmittal

form that is also used to transmit other

forms of labeling, (e.g., circulars,

package labels, and container labels) for

CBER review when a sponsor is

requesting premarket approval of a

product or proposing changes to a

product carton or container labeling.

The many types of promotional

materials are described on Form FDA

2253 for easy reference. For example,

possible submitted promotional

materials could be a consumer

advertisement, a professional sales aid,

or a consumer broadcast advertisement.

A single submission would include two

copies each of the promotional

materials, Form FDA 2253, and the

approved product labeling. Submissions

of multiple applications are handled in

a similar manner as described in the

form.

In 1998, FDA revised 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 revised form had the

following major changes:

1. The revised, harmonized form is

now 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

it may be used by manufacturers of

licensed biological products regulated

by CBER who submit draft and/or final

copies of promotional labeling and

advertisements to the agency. The

revised and harmonized Form FDA

2253 eliminated the need for sponsors

to use two different forms to transmit

similar materials for submission to the

two centers. Although manufacturers of

biological products had the option to

continue to use Form FDA 2567 to

transmit advertisements and

promotional labeling if they wished, the

other uses of Form FDA 2567 remained

unchanged.

2. The revised, harmonized form

updated the information about the types

of promotional materials and the codes

that are used to clarify the type of

advertisement or promotional labeling

(e.g., consumers, professionals, news

services); and it helped ensure that the

submission is complete.

3. The revised form provides for

sponsors to submit specimens of

multiproduct promotional labeling and

advertisements to only two files; to the

approved product application of the

sponsor’s choice (generally the most

frequently promoted product), and to a

company name file. This revision in the

form has saved sponsors time and

money by eliminating the need for

making multiple submissions of the

same promotional materials. In

addition, because the form was revised,

sponsors no longer need to maintain

dual inventories of both forms, and they

now have multiple processing

capabilities.

From October 1, 1999, through

September 30, 2000, 386 sponsors

submitted 12,235 postmarketing reports

via Form FDA 2253 to CDER; this

included 2,343 multiple submissions. In

the same time period 134 sponsors

submitted 4,243 postmarketing reports

via Forms FDA 2253 and 2567 to CBER.

In the Federal Register of December

21, 2000 (65 FR 80437), the agency

requested comments on the proposed

collections of information. The

comments received were all unrelated to

the collection of information published

in the above Federal Register notice and

may be viewed on the FDA Dockets

Management Branch Web site: http://

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

dockets/edockethome.cfm, and by

referring to the above docket number.

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 response2

Total annual

responses3 Hours per response Total hours

CBER (none) ...................... 1344 32 4,243 2 8,486

CDER § 314.81(b)(3)(i) ...... 3865 32 12,395 2 24,790

Total ................................ 33,276

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

2Average number (rounded to the nearest whole number) of submissions submitted annually per sponsor. We note that some sponsors submit

only once per year, whereas one sponsor had 893 submissions in 1999. 3Total number of Form FDA 2253 submissions to CDER and Form FDA 2253 plus Form FDA 2567 to CBER in fiscal year (FY) 1999.

4 Number of sponsors that submitted establishment license applications and product license applications to CBER in FY 1999.

5 Number of sponsors that submitted new drug applications (including applications for new antibiotics), abbreviated new drug applications, and

abbreviated antibiotic applications in FY 1999.

In FY 1999, CDER received a total of

12,395 submissions and CBER received

4,353 submissions that would require

the use of this form. FDA estimates that

2 hours would be required for an

industry regulatory affairs specialist to

fill out the form, collate the

documentation, and send the

submissions to CDER or CBER.

Electronic Submission of Promotional

Materials Regarding Prescription Drugs

and Biologics for Human Use

CDER and CBER are currently piloting

with approximately 20 sponsors,

different methods to submit

postmarketing submissions of

advertising and promotional labeling.

FDA anticipates publishing in the

Federal Register a draft guidance for

industry entitled ‘‘Providing Regulatory

Submissions in Electronic Format—

Prescription Drug Advertising and

Promotional Labeling.’’ By using this

suggested format for electronically

submitting promotional materials, we

anticipate that by January 2002,

sponsors will submit about 20 percent

23266 Federal Register / Vol. 66, No. 89 / Tuesday, May 8, 2001 / Notices

of all materials electronically via Form

FDA 2253. Further, we anticipate

posting a fillable electronic Form FDA

2253 on FDA’s Internet site.

Applicants may then have the option to

fill out the form on their computer, and

with additional software, they can

maintain records regarding submitted

promotional materials.

Dated: May 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11452 Filed 5–7–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01N–0006]

Agency Information Collection

Activities; Submission for OMB

Review; Comment Request; New

Animal Drug Application, Form FDA

356 V

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 June 7,

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:

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.

New Animal Drug Application, Form

FDA 356 V— 21 CFR Part 514 (OMB

Control No. 0910–0032)—Extension

FDA has the responsibility under the

Federal Food, Drug, and Cosmetic Act

(the act) 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 new animal drug

application (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 an 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 of this

collection of information as follows:

TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN 1

21 CFR section No. of

respondents

Annual frequency

per response

Total annual

responses

Hours per

response Total hours

514.1 and 514.6 ..................................... 190 8.33 1,582 211.6 334,751

514.8 ...................................................... 190 8.33 1,582 30 47,460

514.11 .................................................... 190 8.33 1,582 1 1,582

Total ................................................... 383,793

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

The estimate of the burden hours

required for reporting are based on fiscal

year 1999 data. The burden estimate

includes original NADAs, supplemental

NADAs, and amendments to

unapproved applications.

Dated: May 2, 2001.

William K. Hubbard,

Senior Associate Commissioner for Policy,

Planning, and Legislation.

[FR Doc. 01–11454 Filed 5–7–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 01D–0194]

Draft Guidance for Industry on the

Statistical Aspects of the Design,

Analysis, and Interpretation of Chronic

Rodent Carcinogenicity Studies of

Pharmaceuticals; Availability

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) is announcing the

availability of a draft guidance for

industry entitled ‘‘Statistical Aspects of

the Design, Analysis, and Interpretation

of Chronic Rodent Carcinogenicity

Studies of Pharmaceuticals.’’ The

purpose of this document is to provide

guidance to sponsors on the design of

animal carcinogenicity experiments,

methods of statistical analysis of tumor

data, interpretation of study results,

presentation of data and results in

reports, and the submission of tumor

data to FDA statistical reviewers in the

Center for Drug Evaluation and Research

(CDER).

DATES: Submit written comments on the

draft guidance by August 6, 2001.

General comments on agency guidance

documents are welcome at any time.