[Federal Register Volume 67, Number 63 (Tuesday, April 2, 2002)]
[Notices]
[Pages 15576-15577]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-7883]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02D-0095]


Draft Guidance for Industry on Exposure-Response Relationships: 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availability of a draft guidance for industry entitled ``Exposure-
Response Relationships: Study Design, Data Analysis, and Regulatory 
Applications.'' The guidance is intended to provide 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DATES: Submit written or electronic comments on the draft guidance by 
June 3, 2002. General comments on agency guidance documents are welcome 
at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance to the Division of Drug Information (HFD-240), Center for Drug 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, 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 Submit written comments on the draft guidance to the Dockets 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section for electronic access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Lawrence J. Lesko, Office of Clinical 
Pharmacology and Biopharmaceutics, 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 draft guidance for industry 
entitled ``Exposure-Response Relationships: Study Design, Data 
Analysis, and

[[Page 15577]]

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.
    This draft guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The draft guidance, when 
finalized, will represent 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 
(address above) written or electronic 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 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: March 25, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-7883 Filed 4-1-02; 8:45 am]
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