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Agency Information Collection Activities; Submission for OMB Review; Comment Request; The Evaluation of Long-Term Antibiotic Drug Therapy for Persons Involved in Anthrax Remediation Activities

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Information about this document as published in the Federal Register.

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This document has been published in the Federal Register. Use the PDF linked in the document sidebar for the official electronic format.

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Food and Drug Administration, HHS.




The Food and Drug Administration (FDA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.


Fax written comments on the information collection provisions by May 2, 2003.


OMB is still experiencing significant delays in the regular mail, including first class and express mail, and messenger deliveries are not being accepted. To ensure that comments on the information collection are received, OMB recommends that written comments be electronically mailed to or faxed to the Office of Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk Officer for FDA, FAX: 202-395-6974.

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Karen L. Nelson, Office of Information Resources Management (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1482.

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In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.

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The Evaluation of Long-Term Antibiotic Drug Therapy for Persons Involved in Anthrax Remediation Activities—(OMB Control Number 0910-0494)—Extension

Due to a terrorist event during the fall of 2001, approximately 1,200 decontamination workers were placed on long-term antibiotic therapy to protect them from environmental anthrax spores. Through the services of a contractor the FDA is currently administering a survey to all 1,200 decontamination workers to collect important health information pertaining to long term use of antibiotics. This information is critical to the agency's mission in protecting the public health and failure of the FDA to adequately follow up on these workers will reduce the agency's ability to apply lessons learned from the current situation to provide guidance during future public health emergencies should they occur. This could result, not only, in the loss of time and dollars but also in the loss of life if patients stop taking their medicines because they think the drug therapy is responsible for a health problem when in fact it is not. This type of population is likely to never be available for assessment again until a future terrorist event occurs. It would be unacceptable for FDA not to obtain drug experience information from this group to assist in any future public health response to a terrorist attack.

FDA is requesting an extension of the OMB approval of a survey to help FDA's Center for Drug Evaluation and Research evaluate the long-term antibiotic drug therapy in persons involved in anthrax remediation activities. The reason for the extension is to allow for more time to complete the survey, which has been delayed for two reasons. The first reason relates to the delays in cleaning up some of the contaminated sites. Primarily the cleanup of the Brentwood Post Office in Washington, DC, which accounts for approximately 400 of the decontamination workers, was delayed. The clean up at Brentwood is almost complete and it is anticipated that final medical examinations of the Brentwood cleanup workers can begin in earnest in the February/March 2003 timeframe. Once the final medical examination is completed then Market Facts, the contractor hired to conduct the survey, can begin to administer the questionnaire to these workers. The second reason is the result of having to obtain authorization from approximately 35 subcontractor firms (who employed the decontamination workers) to release contact information on the remediation workers. To date, only contact information for approximately 300 workers has been released and further efforts are on going to obtain permission to release the remaining information. The medical service subcontractor is working diligently to obtain the necessary authorizations.

In the Federal Register of January 17, 2003 (68 FR 2561), the agency requested comments on the proposed collections of information. The agency received no comments to the notice.

FDA estimates the burden of this collection of information as follows:

Table 1.—Estimated Annual Reporting Burden1

Type of SurveyNo. of RespondentsAnnual Frequency/ResponseTotal Annual ResponsesHours per ResponseTotal Hours
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The estimated annual reporting burden is based on the Centers for Disease Control and Prevention's administration, in 2001 and 2002, of a similar questionnaire to individuals who were exposed to anthrax spores dispersed during a terrorist event.

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Dated: March 26, 2003.

William K. Hubbard,

Associate Commissioner for Policy and Planning.

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[FR Doc. 03-7821 Filed 4-1-03; 8:45 am]