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single copies of the draft guidance to the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electronic access to the draft guidance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a draft guidance for industry entitled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This draft guidance is being issued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draft guidance represents the agency’s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

23268 Federal Register / Vol. 66, No. 89 / Tuesday, May 8, 2001 / Notices

7a has been renamed Form G3, and

Form G3 now requires States to report

specific ages of the youth inspectors

rather than age ranges.

ANNUAL REPORTING BURDEN

Number of

respondents

Responses

per

respondent

Hours per

response Total burden

Sections I–III—Red Lake Indians .................................................................... 1 1 1 530 530

Sections I–III—States and Territories .............................................................. 59 1 563 33,217

Section IV–A .................................................................................................... 40 1 50 2,000

Section IV–B .................................................................................................... 20 1 42 840

Total .......................................................................................................... ........................ ........................ ........................ 36,587

1 Red Lake Indian Tribe is not subject to tobacco requirements.

Written comments and

recommendations concerning the

proposed information collection should

be sent within 30 days of this notice to:

Stuart Shapiro, Human Resources and

Housing Branch, Office of Management

and Budget, New Executive Office

Building, Room 10235, Washington,

D.C. 20503.

Dated: May 1, 2001.

Richard Kopanda,

Executive Officer, SAMHSA.

[FR Doc. 01–11512 Filed 5–7–01; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Substance Abuse and Mental Health

Services Administration

Cooperative Agreements with Single

State Agencies for Alcohol and Other

Drug Abuse for Conducting

Evaluations

AGENCY: Center for Substance Abuse

Treatment, Substance Abuse and Mental

Health Services Administration, HHS.

ACTION: Cooperative Agreements with

Single State Agencies for Alcohol and

Other Drug Abuse for Assistance to

States for Conducting Evaluations of

their Substance Abuse Treatment

Services.

SUMMARY: This notice is to inform the

public of planned cooperative

agreements that the Substance Abuse

and Mental Health Services

Administration (SAMHSA) Center for

Substance Abuse Treatment (CSAT),

under its State Treatment Needs

Assessment Program (STNAP), intends

to award to Single State Agencies

(SSAs) for Alcohol and Other Drug

Abuse. In fiscal year 2001, CSAT has

approximately $2.1 million available for

7 to 9 awards. Awards will be made if

the applications are scored by the initial

review group and concurred with by the

CSAT National Advisory Council.

Eligibility for cooperative agreements

is limited to SSAs for Alcohol and Other

Drug Abuse because the States have

statutory responsibility for developing

and submitting services needs

assessment estimates in order to receive

a Substance Abuse Prevention and

Treatment (SAPT) Block Grant. By

providing assistance to the States for

conducting evaluations of their

substance abuse treatment services,

CSAT, under its STNAP, seeks to help

States to determine methods for

improving the availability and quality of

treatment. The STNAP objectives are to:

assist States to take advantage of

existing data to develop estimates of

need for services and report these data

on the annual SAPT Block Grant

application; assist States to develop and

institutionalize their capability to use

data that already exist and to manage

data collection and analyses, as needed,

to supplement existing data sources;

assist States to conduct common

assessment studies needed to augment

their existing data and to improve the

opportunities for aggregation of data

across States; and allow for aggregation

of data across States for SAMHSA/CSAT

to use in secondary analyses, multiState comparisons, and for augmenting

other information collected within

SAMHSA.

Authority: Cooperative agreements with

SSAs for Alcohol and Other Drug Abuse will

be made under the authority of section 1935

(b)(1)(C) and (b)(3) of the Public Health

Service Act, as amended (42 USC 300x-35),

and section 1929. The Catalog of Federal

Domestic Assistance number is 93.238.

FOR FURTHER INFORMATION CONTACT: Nita

Fleagle, CSAT, SAMHSA, Rockwall II,

Suite 840, 5600 Fishers Lane, Rockville,

MD 20857; telephone (301) 443–8572; email: nfleagle@samhsa.gov

Dated: May 1, 2001.

Richard Kopanda,

Executive Officer, SAMHSA.

[FR Doc. 01–11448 Filed 5–7–01; 8:45 am]

BILLING CODE 4162–20–P

DEPARTMENT OF HOUSING AND

URBAN DEVELOPMENT

[Docket No. FR–4650–N–32]

Notice of Submission of Proposed

Information Collection to OMB;

Emergency Comment Request for HUD

Alternative for SF 424 Forms,

Application for Federal Assistance and

Attendent Forms

AGENCY: Office of The Chief Information

Officer, HUD.

ACTION: Notice.

SUMMARY: The proposed information

collection requirement described below

has been submitted to the Office of

Management and Budget (OMB) for

emergency review and approval, as

required by the Paperwork Reduction

Act. The Department is soliciting public

comments on the subject proposal.

DATES: Comments Due Date: May 15,

2001.

ADDRESSES: Interested persons are

invited to submit comments regarding

this proposal. Comments must be

received within seven (7) days from the

date of this Notice. Comments should

refer to the proposal by name/or OMB

approval number) and should be sent to:

Joseph F. Lackey, Jr., HUD Desk Officer,

Office of Management and Budget, New

Executive Office Building, Washington,

DC 20503.

FOR FURTHER INFORMATION CONTACT:

Wayne Eddins, Reports Management

Officer, Q, Department of Housing and

Urban Development, 451 Seventh Street,

SW., Washington, DC 20410; e-mail

Wayne_Eddins@HUD.gov; telephone

(202) 708–2374. This is not a toll-free

number. Copies of available documents