[Federal Register: January 10, 2000 (Volume 65, Number 6)]
[Notices]
[Page 1399-1400]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr10ja00-52]

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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Draft Guidance for Industry on Photosafety Testing; Availability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availability of a draft guidance for industry entitled ``Photosafety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 The draft guidance is intended to help applicants decide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 The draft guidance describes a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DATES: Submit written comments on the draft guidance document by April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ADDRESSES: Copies of this draft guidance for industry are available on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written requests for single copies of the draft guidance to the Drug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 Submit written comments on the draft guidance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draft guidance for industry entitled ``Photosafety Testing.''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draft guidance is intended to help applicants decide whether to test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

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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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