[Federal Register Volume 66, Number 89 (Tuesday, May 8, 2001)]
[Notices]
[Pages 23266-23267]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-11450]


-----------------------------------------------------------------------

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Draft Guidance for Industry on the Statistical Aspects of the 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availability of a draft guidance for industry entitled ``Statistical 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DATES: Submit written comments on the draft guidance by August 6, 2001.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.

[[Page 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ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Drug Information Branch (HFD-240), Center for Drug 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 self-addressed 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on the draft guidance to the Dockets Management Branch (HFA-305), Food 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to the draft guidance document.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    FDA is announcing the availability of a draft guidance for industry 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 long-term 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