[Federal Register Volume 68, Number 88 (Wednesday, May 7, 2003)]
[Notices]
[Page 24487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11216]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-5453]


Guidance for Industry on Photosafety Testing; 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 ``Photosafety 
Testing.'' This guidance provides recommendations on when to test for 
photoirritation and assess the potential of drug products to enhance 
ultraviolet (UV)-associated skin carcinogenesis.

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

ADDRESSES: Submit written 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. 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: Abigail C. Jacobs, Center for Drug 
Evaluation and Research (HFD-540), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-2020.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry 
entitled ``Photosafety Testing.'' This guidance provides 
recommendations on when to test for photoirritation and assess the 
potential of drug products to enhance UV-associated skin 
carcinogenesis.
    In the Federal Register of January 10, 2000 (65 FR 1399), FDA 
published a notice making available a draft guidance entitled 
``Photosafety Testing.'' The notice gave interested persons an 
opportunity to submit comments. As a result of the comments, certain 
sections of this guidance were reworded to improve clarity. This 
guidance further emphasizes that a flexible approach can be used to 
address adverse photoeffects and that a specific assay is not required. 
Moreover, it encourages the development of methods that can be 
efficiently used to evaluate human safety. This guidance describes a 
consistent, science-based approach for testing of topically and 
systemically administered drug products. It also describes basic 
concepts of photobiology and phototesting.
    This guidance is being issued consistent with FDA's good guidance 
practice regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on nonclinical photosafety testing. 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 or http://www.fda.gov/ohrms/dockets/default.htm.

    Dated: April 30, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-11216 Filed 5-6-03; 8:45 am]
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