[Federal Register Volume 65, Number 23 (Thursday, February 3, 2000)]
[Notices]
[Pages 5353-5354]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-2299]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 99D-0236]


Guidance for Industry on Skin Irritation and Sensitization 
Testing of Generic Transdermal Drug Products; 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 ``Skin Irritation and 
Sensitization Testing of Generic Transdermal Drug Products.'' This 
guidance provides assistance to sponsors of abbreviated new drug 
applications (ANDA's) by recommending study designs and scoring systems 
that can be used to test skin irritation and sensitization during 
development of transdermal products. Skin irritation and sensitization 
should be assessed because the condition of the skin may affect the 
absorption of a drug from a transdermal system, thus affecting the 
efficacy or safety of the product. This guidance does not address the 
actual bioequivalence studies

[[Page 5354]]

necessary for a particular transdermal product.

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

ADDRESSES:  Copies of this 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 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 guidance to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:  Mary M. Fanning, Center for Drug 
Evaluation and Research (HFD-600), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-5845.

SUPPLEMENTARY INFORMATION:  FDA is announcing the availability of a 
guidance for industry entitled ``Skin Irritation and Sensitization 
Testing of Generic Transdermal Drug Products.'' Transdermal products 
have properties that may lead to skin irritation and/or sensitization. 
The delivery system, or the system in conjunction with the drug 
substance, may cause these reactions. Skin irritation and skin 
sensitization studies are designed to detect irritation and 
sensitization under conditions of maximal stress and may be used during 
the assessment of transdermal drug product for ANDA's.
    A draft guidance entitled ``Skin Irritation and Sensitization 
Testing of Generic Transdermal Drug Products'' was published in the 
Federal Register of February 26, 1999 (64 FR 9516). Eight comments were 
received between February and April of 1999, and this guidance has been 
revised after careful consideration of those comments.
    This Level 1 guidance is being issued consistent with FDA's good 
guidance practices (62 FR 8961, February 27, 1997). The guidance 
represents the agency's current thinking on skin irritation and 
sensitization testing of generic transdermal drug products. 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, at any time, submit written comments on the 
guidance to the Dockets Management Branch (address above). 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.

    Dated: January 24, 2000.
Margaret M. Dotzel,
Acting Associate Commissioner for Policy.
[FR Doc. 00-2299 Filed 2-2-00; 8:45 am]
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