[Federal Register Volume 68, Number 63 (Wednesday, April 2, 2003)]
[Notices]
[Pages 16059-16060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-7821]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0354]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: 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.

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

ADDRESSES: 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 [email protected] or faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Stuart Shapiro, Desk 
Officer for FDA, FAX: 202-395-6974.

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

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

[[Page 16060]]

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 Burden\1\
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                                                                       Annual Frequency/       Total Annual
                 Type of Survey                   No. of Respondents        Response            Responses        Hours per Response      Total Hours
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Telephone                                                      1,200                    1                1,200                  .25                  300
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Total                                                                                                                                                300
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\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.

    Dated: March 26, 2003.
William K. Hubbard,
Associate Commissioner for Policy and Planning.
[FR Doc. 03-7821 Filed 4-1-03; 8:45 am]
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