[Federal Register Volume 67, Number 160 (Monday, August 19, 2002)]
[Notices]
[Pages 53805-53806]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20915]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0354]


Agency Emergency Processing under OMB Review; 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 a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for emergency processing under the 
Paperwork Reduction Act of 1995 (the PRA). The proposed collection of 
information concerns the evaluation of approximately 1,200 people 
involved in the decontamination/cleanup (``remediation'') of various 
facilities contaminated with anthrax spores during a terrorist event in 
the fall of 2001. The 1,200 decontamination workers have been on 
continuous prophylactic antibiotics for greater than 60 days and FDA 
wants to evaluate these workers for adverse events that may have 
occurred in light of this prolonged drug exposure.

DATES: Submit written comments on the collection of information by 
September 3, 2002.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Stuart Shapiro, Desk Officer for FDA. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

FOR FURTHER INFORMATION CONTACT: Peggy Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: FDA has requested emergency processing of 
this proposed collection of information under section 3507(j) of the 
PRA (44 U.S.C. 3507(j) and 5 CFR 1320.13). The information is critical 
to the agency's mission in protecting the public health and is needed 
prior to the expiration of the normal time periods for OMB clearance 
under the PRA regulations (5 CFR part 1320). As a result of recent 
terrorist events, a number of individuals

[[Page 53806]]

were potentially exposed to anthrax at various facilities. The Federal 
Government contracted to have the subject facilities decontaminated of 
residual anthrax spores. This cleanup work has been ongoing, at the 
affected sites, since late 2001. The workers employed in the 
decontamination effort were placed on long-term prophylactic 
antibiotics. Although FDA is interested in collecting data regarding 
adverse events on all 1,200 decontamination workers; there are 
approximately 400 decontamination workers at the Brentwood Post Office 
facility in Washington, DC, who continue to receive antibiotics. These 
400 workers are scheduled for a final medical examination 10 days after 
the final antibiotic is taken. FDA needs to have OMB authorization in 
place in time to administer the survey to these workers when they 
present for their final medical examination. It is estimated that most 
of the cleanup work will be completed by the end of September 2002. FDA 
will also be administering the same survey to the remaining 800 
decontamination workers who were not offered final medical 
examinations. Many of these workers have already left the 
decontamination site. FDA is requesting that emergency OMB approval to 
administer the survey be granted because the longer the timespan 
between a worker's having stopped taking an antibiotic and the time the 
questionnaire is administered, the less reliable the answers provided 
become and the more difficult it is to locate a former worker.
    FDA invites comments on: (1) Whether the proposed collection of 
information is necessary for the proper performance of FDA's functions, 
including whether the information will have practical utility; (2) the 
accuracy of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.

The Evaluation of Long-Term Antibiotic Drug Therapy for Persons 
Involved in Anthrax Remediation Activities

    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 FDA plans to administer a survey to all 1,200 
decontamination workers. For those decontamination workers that are 
still on site at the Brentwood Postal Facility, the contractor shall 
work with the medical service subcontractor to establish a toll free 
800 telephone number that a worker can call as part of their post-
antibiotic followup visit. The Government estimates that approximately 
400 decontamination workers will place calls to an 800 number. The 
contractor shall have a qualified interviewer available to administer 
the assessment tool to these individuals during the telephone calls. 
Whereas approximately 20 percent of the decontamination workers are 
Spanish speaking, the contractor shall be able to conduct interviews in 
both English and Spanish. For those decontamination workers that have 
left the Brentwood Postal Facility, and for all other sites (about 800 
total), the contractor shall administer the same survey via the 
telephone, but the contractor shall initiate these calls. If the 
contractor is not able to contact the decontamination worker on the 
initial telephone call or the worker is nonresponsive, the contractor 
shall attempt to followup with these workers up to three additional 
times.
    Failure of FDA to adequately followup 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 human 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. Because the stress of exposure 
from a terrorist act can in itself cause many symptoms that are similar 
to adverse events that might be caused by various therapies, it is 
extremely important that FDA obtain information on individuals who took 
these antibiotics but were not subjected to the anxiety and stress 
associated with a terrorist event. 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 estimates the burden of this collection of information as 
follows:

             Table 1.-- Estimated Annual Reporting Burden\1\
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                                Annual
   Type of         No. of      Frequency     Total    Hours per   Total
    Survey      Respondents       per       Annual     Response   Hours
                               Response    Responses
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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 CDC's 
administration, in 2001 and 2002, of a similar questionnaire to 
individuals who were exposed to anthrax spores dispersed during a 
terrorist event.

    Dated: June 13, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-20915 Filed 8-16-02; 8:45 am]
BILLING CODE 4160-01-S