Zdrowie i gospodarka · 27.06.2002
Agency Information Collection Activities; Proposed Collection; Comment Request; Telephone Questionnaire Administration to Control Subjects Recruited into FDA Lyme Vaccine Safety Study, “A Case-Control Study of HLA Type and T-Cell Reactivity to Recombinant Outer Surface Protein A and Human Leukocyte Function-Associated Antigen-1”
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the use of a survey questionnaire to be administered by telephone interview to control subjects recruited into and participating in a vaccine safety study conducted by FDA to investigate reports of arthritis following administration of the Lyme disease vaccine. Informed consent for administration of this questionnaire will have been received prior to the interview, and the interview is to be conducted at a time specified by the control subject at the time of initial recruitment into this study. This questionnaire is an abridged version of one used in followup survey interviews with persons reported to the national Vaccine Adverse Event Reporting System (VAERS) as having developed joint problems or arthropathy following Lyme disease vaccine administration.