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.

Federal Register / Vol. 66, No. 89 / Tuesday, May 8, 2001 / Notices 23267

ADDRESSES: Submit written requests for

single copies of the draft guidance to the

Drug Information Branch (HFD–240),

Center for Drug Evaluation and

Research, Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857. Send one selfaddressed adhesive label to assist that

office in processing your requests.

Submit written comments on the draft

guidance to the Dockets Management

Branch (HFA–305), Food and Drug

Administration, 5630 Fishers Lane, rm.

1061, Rockville, MD 20852. See the

SUPPLEMENTARY INFORMATION section for

electronic access to the draft guidance

document.

FOR FURTHER INFORMATION CONTACT: Karl

K. Lin, Center for Drug Evaluation and

Research (HFD–715), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–827–3093.

SUPPLEMENTARY INFORMATION:

I. Background

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.’’ Assessment of the

risk of drug exposure in humans

includes an assessment of

carcinogenicity in tests in rodents. In a

carcinogenicity study of a new drug

using a series of increasing dose levels,

statistical tests are an important

component of the analysis. The Division

of Biometrics in the Office of

Biostatistics, CDER is responsible for

conducting statistical reviews of longterm animal (rodent) carcinogenicity

studies of pharmaceuticals submitted by

drug sponsors to FDA.

In statistical reviews of

carcinogenicity studies, statisticians

evaluate the validity of the designs and

the appropriateness of methods of data

analysis used by the sponsor. They also

use raw study data in electronic form to

perform additional statistical analyses.

The purpose of this document is to

provide guidance to sponsors on

statistical issues related to the design of

animal carcinogenicity experiments,

methods of 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.

This draft guidance is being issued

consistent with FDA’s good guidance

practices regulation (21 CFR 10.115; 65

FR 56468, September 19, 2000). The

draft guidance represents the agency’s

current thinking on the statistical

aspects of the design, analysis, and

interpretation of chronic rodent

carcinogenicity studies of

pharmaceuticals. It does not create or

confer any rights for or on any person

and does not operate to bind FDA or the

public. An alternative approach may be

used if such approach satisfies the

requirements of the applicable statutes

and regulations.

II. Comments

Interested persons may submit to the

Dockets Management Branch (address

above) written comments on the draft

guidance. Two copies of any comments

are to be submitted, except that

individuals may submit one copy.

Comments are to be identified with the

docket number found in brackets in the

heading of this document. The draft

guidance and received comments are

available for public examination in the

Dockets Management Branch between 9

a.m. and 4 p.m., Monday through

Friday.

III. Electronic Access

Persons with access to the Internet

may obtain the document at either http:/

/www.fda.gov/cder/guidance/index.htm

or http://www.fda.gov/ohrms/dockets/

default.htm.

Dated: April 30, 2001.

Ann M. Witt,

Acting Associate Commissioner for Policy.

[FR Doc. 01–11450 Filed 5–7–01; 8:45 am]

BILLING CODE 4160–01–S

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Agency Information Collection

Activities: Submission for OMB

Review; Comment Request

Periodically, the Substance Abuse and

Mental Health Services Administration

(SAMHSA) will publish a list of

information collection requests under

OMB review, in compliance with the

Paperwork Reduction Act (44 U.S.C.

Chapter 35). To request a copy of these

documents, call the SAMHSA Reports

Clearance Officer on (301) 443–7978.

Substance Abuse Prevention and

Treatment (SAPT) Block Grant

Application Guidance and Instructions,

FY 2002–2004 (OMB No. 0930–0080,

Revision)

Sections 1921 through 1935 of the

Public Health Service Act (U.S.C. 300x–

21 to 300x–35) provide for annual

allotments to assist States to plan, carry

out, and evaluate activities to prevent

and treat substance abuse and for

related activities. Under the provisions

of the law, States may receive

allotments only after an application is

submitted and approved by the

Secretary, DHHS. For the federal fiscal

year 2002–2004 SAPT block grant

application cycles, the Substance Abuse

and Mental Health Services

Administration (SAMHSA) will provide

States with revised application guidance

and instructions to implement changes

made by Public Law 106–310, signed by

the President on October 17. Revisions

to the previously-approved application

resulting from the new SAMHSA

authorizing legislation reflect the

following changes: (1) Section 1922(a)

under which States were required to use

35% of the funds on drug related

activities and 35% on alcohol related

activities (42 U.S.C. 300x–22) is

repealed. (2) The Section 1925

requirement for the States to maintain a

revolving fund of $100,000 to assist

with half way houses for persons

recovering from drug or alcohol abuse is

now made optional (42 U.S.C. 300x–25).

(3) Section 1930, which requires the

States to maintain their financial

support for substance abuse services at

a level equal to the average of what they

had spent the previous two years, is

amended to permit non-recurring

expenditures for a singular purpose to

be excluded from the calculation of the

Maintenance of Effort (MOE)

requirement (42 U.S.C. 300x–30). (4)

Section 1952 is amended to allow any

amount paid to a State for a fiscal year

to be available for obligation and

expenditure until the end of the fiscal

year following the fiscal year for which

the amounts were paid, in effect giving

a State two years to obligate and spend

(42 U.S.C. 300x–62).

In addition, changes are being made

to the annual reporting requirements

associated with Section 1926 (42 U.S.C.

300x–26), which requires States to have

in effect a law prohibiting access and

distribution of tobacco products to

minors under age 18. In Section II, the

following changes are being made with

respect to Goal #8 and Attachment G: (1)

In Goal #8, States will not be required

to report on activities that were reported

in previous applications (i.e., the

requirement to report on prior year

compliance information is eliminated).

(2) In Attachment G: (a) questions are reordered so they are in chronological

order to facilitate reporting on

compliance activities; (b) seven of the

nine questions are revised to define

more precisely the information that

SAMHSA needs in order to review and

approve applications and eliminate

duplication in State reporting; (c) Matrix