[Federal Register Volume 68, Number 12 (Friday, January 17, 2003)]
[Notices]
[Pages 2561-2562]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-1254]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02N-0354]


Agency Information Collection Activities; Proposed Collection; 
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 Adminsitration (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 
(PRA), Federal agencies are required to publish notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
to allow 60 days for public comment in response to the notice. This 
notice solicits comments on the information collection requirements 
relating to the evaluation of long-term antibiotic drug therapy for 
persons involved in anthrax remediation activities. In the Federal 
Register of October 8, 2002 (67 FR 62727), FDA published a notice 
announcing the Office of Management and Budget's (OMB's) approval of 
this collection of information (OMB control number 0910-0494). Because 
this was an emergency approval that will expire on March 31, 2003, FDA 
in this notice is following the normal PRA clearance procedures by 
issuing this notice.

DATES: Submit written or electronic comments on the collection of 
information by March 18, 2003.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.accessdata.fda.gov/scripts/oc/dockets/edockethome.cfm. 
Submit written comments on the collection of information to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. All comments should be identified 
with the docket number found in brackets in the heading of this 
document.

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

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of Information'' is defined in 44 U.S.C. 3502(3) and 5 CRF 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) 
requires Federal agencies to provide a 60-day notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, 
before submitting the collection to the OMB for approval. To comply 
with this requirement, FDA is publishing notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, 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 (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 the 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 was delayed; this post office accounts for approximately 
400 of the decontamination workers. The cleanup 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

[[Page 2562]]

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

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

    Dated: January 15, 2003.
Margaret M. Dotzel,
Assistant Commissioner for Policy.
[FR Doc. 03-1254 Filed 1-16-03; 3:44 pm]
BILLING CODE 4160-01-S