[Federal Register Volume 64, Number 38 (Friday, February 26, 1999)]
[Notices]
[Pages 9516-9517]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-4763]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-0236]


Draft Guidance for Industry on Skin Irritation and Sensitization 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availability of a draft guidance for industry entitled ``Skin 
Irritation and Sensitization Testing of Generic Transdermal Drug 
Products.'' This draft guidance provides assistance to sponsors of 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. To fully 
evaluate the equivalence of a transdermal product to a reference listed 
drug, skin irritation and sensitization should be assessed because skin 
conditions may affect the efficacy or safety of the product. This 
guidance does not address the actual bioequivalence studies that would 
be needed for a particular transdermal drug product.

DATES: Written comments may be submitted on the draft guidance document 
by April 27, 1999. 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ADDRESSES: Copies of this draft guidance for industry are available on 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/

[[Page 9517]]

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the draft guidance to the Drug Information Branch (HFD-210), Center for 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comments on the draft guidance to the Dockets Management Branch (HFA-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 20857.

FOR FURTHER INFORMATION CONTACT: Mary 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 
draft guidance for industry entitled ``Skin Irritation and 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 skin reactions. In the 
development of transdermal products, dermatologic adverse events are 
evaluated primarily with animal studies and safety evaluations in the 
context of large clinical trials generally associated with the 
submission of new drug applications. Separate skin irritation and skin 
sensitization studies also are used for this purpose. These later 
studies are designed to detect irritation and sensitization under 
conditions of maximal stress. These studies may be used during the 
assessment of transdermal drug products for ANDA's.
     This draft level 1 guidance is being issued consistent with FDA's 
good guidance practices (62 FR 8961, February 27, 1997). It 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 statute, regulations, or 
both.
     Interested persons may submit written comments on the draft 
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 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: February 19, 1999.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 99-4763 Filed 2-25-99; 8:45 am]
BILLING CODE 4160-01-F