[Federal Register Volume 65, Number 6 (Monday, January 10, 2000)]
[Notices]
[Pages 1399-1400]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-429]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-5435]


Draft Guidance for Industry on Photosafety Testing; Availability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availability of a draft guidance for industry entitled ``Photosafety 
Testing.'' The draft guidance is intended to help applicants decide 
whether they should test for photosensitivity and assess potential 
human risk for photochemical carcinogenesis (cancer) and enhancement of 
UV-induced skin carcinogenesis during the development of topically and 
systemically administered drug products. The draft guidance describes a 
consistent, science-based approach for considering testing. FDA is 
soliciting comments and seeking information from interested persons 
concerning photosafety testing.

DATES: Submit written comments on the draft guidance document by April 
10, 2000. General comments on agency guidance documents are welcome at 
any time.

ADDRESSES: Copies of this draft guidance for industry are available on 
the Internet at http://www.fda.gov/cder/guidance/index.htm. Submit 
written requests for single copies of the draft guidance to the Drug 
Information Branch (HFD-210), 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 Submit written comments on the draft guidance 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.

FOR FURTHER INFORMATION CONTACT: Joseph J. DeGeorge, Center for Drug 
Evaluation and Research (HFD-024), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-594-5476.

SUPPLEMENTARY INFORMATION: FDA is announcing the availability of a 
draft guidance for industry entitled ``Photosafety Testing.'' This 
draft guidance is intended to help applicants decide whether to test 
for photosensivity and potential human risk for photochemical 
carcinogenesis and enhancement of UV-induced skin carcinogenesis by 
topically and systemically administered drug products.
    In the absence of data from photosensitivity tests conducted in 
animals or humans, warnings about the potential for photosensitization 
generally have been added to labels after adverse reactions resulted 
during widespread clinical use of products. Identification of 
photosensitivity effects before widespread human exposure is preferable 
to learning via adverse event reports.
    This draft guidance considers: (1) Photosensitivity and 
photococarcinogenicity, (2) testing of drug product or testing of drug

[[Page 1400]]

substance, (3) testing for photosensitivity (photoirritation and 
photoallergy), (4) testing for the enhancement of UV-associated skin 
carcinogenesis (direct photochemical carcinogenicity or indirect 
effects in skin), (5) reasons for a separate approach to testing 
nonphotosensitizing drugs for long-term photosafety, and (6) current 
needs for assay development.
    This Level 1 draft guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). The draft 
guidance represents the agency's current thinking on testing for 
photosafety. 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, regulations, or both.
    Interested persons may, on or before April 10, 2000, 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.

    Dated: December 29, 1999.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-429 Filed 1-7-00; 8:45 am]
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