[Federal Register Volume 63, Number 190 (Thursday, October 1, 1998)]
[Notices]
[Pages 52740-52741]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-26228]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0776]


Food and Drug Administration Modernization Act of 1997; 
Allergenic Patch Test Kits; Request for Comments or Data

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is requesting any 
comments, information, or data regarding topically applied allergenic 
products used for the diagnosis of Type IV allergies (also referred to 
as delayed hypersensitivity or cell-mediated immune reactions). FDA is 
gathering this information in response to a House Report, which 
accompanied the Food and Drug Administration Modernization Act of 1997 
(FDAMA), requesting the Secretary, Health and Human Services (HHS), in 
consultation with the National Institute for Occupational Safety and 
Health (NIOSH), FDA, medical experts, and manufacturers to conduct a 
study of topically applied allergenic products (patch tests) used for 
the diagnosis of Type IV allergies. The results of this study will be 
submitted to the House Committee on Commerce and the Senate Committee 
on Labor and Human Resources.

DATES: Submit any written comments or data by November 2, 1998.

ADDRESSES: Submit any written comments or data to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Stephen M. Ripley, Center for 
Biologics Evaluation and Research (HFM-17), Food and Drug 
Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-
6210.

SUPPLEMENTARY INFORMATION:

I. Background

    On November 21, 1997, the President signed FDAMA into law (Pub. L. 
105-115). The H. Rept. 105-307, section 17. Reports, which accompanied 
FDAMA, requested, in part, that the Secretary of the Department of 
Health and Human Services (the Secretary) in consultation with NIOSH, 
FDA, medical experts, and manufacturers, conduct a study of topically 
applied allergenic products used for the diagnosis of Type IV allergies 
(patch tests) and submit a report on the results of the study to the 
House Committee on Commerce and the Senate Committee on Labor and Human 
Resources. It was requested to the extent feasible, that the report 
should: (1) Examine the extent of allergic skin reactions and contact 
dermatitis in the workplace; (2) assess the current availability of 
topically applied allergic products used for the diagnosis of Type IV 
allergies (patch tests), compared with their availability in the 1980's 
and with their availability in other countries; and (3) list by year, 
since 1970, the number of adverse reaction reports filed with FDA 
resulting from the use of topically applied allergenic products used 
for the diagnosis of Type IV allergies and describe, to the extent 
possible, whether those adverse reactions resulted from

[[Page 52741]]

commercial allergens or allergens that were individually prepared by a 
patient, physician, pharmacist, or other person. The report is to be 
submitted within 1 year of the enactment of FDAMA.

II. Discussion

    Contact dermatitis is the most common, nontrauma-related, 
occupational illness in the United States. Occupational contact 
dermatitis results from skin contact with an agent found in a workplace 
setting. The dermatitis can be clinically evident as an acute, 
subacute, or chronic condition. It can be further classified as an 
irritant contact dermatitis or as an allergic contact dermatitis, a 
Type IV, delayed or cell-mediated, immune reaction. The principal 
diagnostic tools for dermatologists, allergists, and other physicians 
attempting to diagnose and determine the cause(s) of allergic 
dermatitis are the patch test kits, which are regulated by FDA as 
biological products.
    In recent years, the licensing of allergenic patch test kits by FDA 
has been the subject of discussion. One of the issues that has been 
discussed, and is part of the study, includes the availability or 
supply of patch test kits and of specific allergens in those kits. In 
response to the House Report, FDA is working with NIOSH to conduct the 
requested study and gather any information on patch test kits. FDA is 
also seeking public input from the medical community, manufacturers, 
and other experts via this Federal Register notice. FDA will consider 
this information in preparation of the report.

III. Submissions

    Interested persons may submit by November 2, 1998, any comments, 
information, or data responsive to the above content of the report to 
the Dockets Management Branch (address above). Two copies of any 
comments, information, or data are to be submitted, except that 
individuals may submit one copy. Comments and data should be identified 
with the docket number found in the brackets in the heading of this 
document. All information submitted will be placed on public display 
and will be subject to public disclosure. Trade secrets and 
confidential information, as well as information that could be used to 
identify persons, such as individual patients whose privacy should be 
maintained, should be deleted before the information is submitted. All 
received comments and data are available for public examination in the 
Dockets Management Branch between 9 a.m. and 4 p.m., Monday through 
Friday.

    Dated: September 23, 1998.
 William K. Hubbard,
 Associate Commissioner for Policy Coordination.
[FR Doc. 98-26228 Filed 9-30-98; 8:45 am]
BILLING CODE 4160-01-F