[Federal Register: April 2, 2002 (Volume 67, Number 63)]
[Notices]
[Page 15576-15577]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02ap02-97]
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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Draft Guidance for Industry on Exposure-Response Relationships: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availability of a draft guidance for industry entitled ``Exposure-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DATES: Submit written or electronic comments on the draft guidance by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ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug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 Submit written comments on the draft guidance to the Dockets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section for electronic access to the draft guidance document.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]
BILLING CODE 4160-01-S