[Federal Register Volume 68, Number 87 (Tuesday, May 6, 2003)]
[Notices]
[Pages 24004-24005]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11074]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0095]


Guidance for Industry on Exposure-Response Relationships--Study 
Design, Data Analysis, and Regulatory Applications; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance for industry entitled ``Exposure-Response 
Relationships--Study Design, Data Analysis, and Regulatory 
Applications.'' The guidance provides recommendations for sponsors of 
investigational new drug applications (INDs) and applicants submitting 
new drug applications (NDAs) or biologics license applications (BLAs) 
on the use of exposure-response information in the development of 
drugs, including therapeutic biologics.

DATES:  Submit written or electronic comments on agency guidances at 
any time.

[[Page 24005]]


ADDRESSES: Submit written or electronic requests for single copies of 
this guidance to the Division of Drug Information (HFD-240), Center for 
Drug Evaluation and Research, Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857 or the Office of Communication, 
Training, and Manufacturers Assistance (HFM-40), Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 1401 
Rockville Pike, Rockville, MD 20852-1448. Send one self-addressed 
adhesive label to assist that office in processing your requests. 
Submit written comments on the guidance to the Dockets Management 
Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852. Submit electronic comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT:
    Lawrence J. Lesko, Center for Drug Evaluation and Research (HFD-
850), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 
20857, 301-594-5690, or
    David Green, Center for Biologics Evaluation and Research (HFM-
579), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 
20852, 301-827-5349.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Exposure-Response Relationships--Study Design, Data 
Analysis, and Regulatory Applications.'' This guidance provides 
recommendations on the use of exposure-response information in the 
development of drugs, including therapeutic biologics. The guidance 
describes: (1) The uses of exposure-response studies in regulatory 
decisionmaking; (2) the important considerations in exposure-response 
study designs to ensure valid information; (3) the strategy for 
prospective planning and data analyses in the exposure-response 
modeling process; (4) the integration of assessment of exposure-
response relationships into all phases of drug development; and (5) the 
format and content of reports of exposure-response studies.
    In the Federal Register of April 2, 2002 (67 FR 15576), FDA 
announced the availability of a draft guidance for industry. The April 
2002 document gave interested persons an opportunity to submit comments 
through June 3, 2002. The agency received 12 comments on the draft 
guidance. All comments received during the comment period have been 
carefully reviewed and changes were made to this guidance, where 
appropriate.
    This guidance is being issued consistent with FDA's good guidance 
practices (21 CFR 10.115). This guidance represents the agency's 
current thinking on study design, data analysis, and regulatory 
applications of exposure-response relationships. 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 (see 
ADDRESSES) written or electronic comments on the guidance at any time. 
Two paper copies of mailed comments are to be submitted, except that 
individuals may submit one paper copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. The 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 
http://www.fda.gov/cder/guidance/index.htm, http://www.fda.gov/cber/guidelines.htm, or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 29, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11074 Filed 5-5-03; 8:45 am]
BILLING CODE 4160-01-S