[Federal Register: October 1, 1998 (Volume 63, Number 190)] [Notices] [Page 52740-52741] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr01oc98-84] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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