[Federal Register Volume 78, Number 143 (Thursday, July 25, 2013)]
[Notices]
[Pages 44957-44958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-17909]


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DEPARTMENT OF HOMELAND SECURITY


Agency Information Collection Activities: BioWatch Filter Holder 
Log, Filter Holder Log DHS Form 9500

AGENCY: Office of Health Affairs, DHS.

ACTION: 60-Day Notice and request for comments; Extension without 
change of a currently approved collection.

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SUMMARY: The Department of Homeland Security, Office of Health Affairs/
OCMO Early Detection Division, will submit the following Information 
Collection Request (ICR) to the Office of Management and Budget (OMB) 
for review and clearance in accordance with the Paperwork Reduction Act 
of 1995 (Pub. L. 104-13, 44 U.S.C. Chapter 35).

DATES: Comments are encouraged and will be accepted until September 23, 
2013. This process is conducted in accordance with 5 CFR 1320.1

ADDRESSES: Written comments and questions about this Information 
Collection Request should be forwarded to Office of Health Affairs/OCMO 
Early Detection Division, DHS Attn.: Daniel Yereb, [email protected] 703-
647-8052.

SUPPLEMENTARY INFORMATION: Following collection, the filter samples are 
transported to a local Laboratory Response Network (LRN) laboratory for 
analysis. Should laboratory analysis determine the presence of one or 
more of the organisms of concern, additional analysis, collection, and 
response activities are conducted to determine the risk to public 
health, and to take appropriate public health, emergency response, and 
law enforcement actions.
    The BioWatch Program provides funding to participating 
jurisdictions for the cost of collection and laboratory analysis 
activities, including the preparation and maintenance of required 
documentation. The filter holder log form is part of the documentation 
required by federal law enforcement for the BioWatch Program.
    The filter holder log is required to create a unique record of the 
filter installed plus give a written chain-of-custody record tied to 
each collected filter sample. In the event of a positive laboratory 
result and subsequent determination of the presence of an organism of 
concern, a variety of law enforcement organizations may become engaged 
in the process of determining if any criminal activity has taken place. 
The Federal Bureau of Investigation (FBI) instructed the BioWatch 
Program to maintain a written record for each collected filter sample 
to support law enforcement activities, including criminal prosecution 
in the case of a deliberate release of a biological warfare agent. In 
addition, filter holder logs (chain-of-custody records) should be 
consistent nationwide for all BioWatch jurisdictions.
    Written records are required to meet FBI evidentiary standards for 
establishing the chain of custody for any filter samples used for 
criminal prosecution (chain of custody is the tracking and 
documentation of the physical control of evidence at all stages in the 
collection and analysis process). The memorandum from the FBI to DHS 
directing the creation of written records is included in Attachment 1.
    Collection of written records establishing chain of custody for 
samples containing biological agents and toxins for the purpose of 
evidence in a criminal proceeding is consistent with the ``Best 
Evidence Rule'', Section 1002, of the federal Rules of Evidence 
(Attachment 2).
    The FBI requirement levied on the BioWatch Program is consistent 
with Section 7 of the FBI Quality Assurance Guidelines for Laboratories 
Performing Microbial Forensic Work, produced by the members of the 
Scientific Working Group on Microbial Genetics and Forensics (SWGMGF) 
Attachment 3. Such record keeping supports mandatory reporting 
requirements directed by The APHIS Interim Final Rule 7 CFR Part 331, 
repeated at 9 CFR

[[Page 44958]]

Part 121 Agricultural Bioterrorism Protection Act of 2002; Possession, 
Use, and Transfer of Biological Agents and Toxins; Interim Final Rule; 
FR citation: 67 FR 76908 and the CDC Interim Final Rule 42 CFR Part 73 
Possession, Use, and Transfer of Select Agents and Toxins; Interim 
Final Rule; FR citation: 67 FR 76886, inter alia.
    Information is collected in writing by a representative of a local 
BioWatch jurisdiction (either an employee, or a contractor) assigned 
responsibility for filter installation, removal, and transportation 
using a standardized log developed by the BioWatch Systems Program 
Office (SPO) and supplied by the jurisdiction.
    A filter holder log is initiated for each new filter sample on 
installation in the aerosol collector device, and is completed 
(normally) 24 hours later when the filter sample is removed from the 
device for transportation to the analysis laboratory. The completed 
logs are archived by the local BioWatch jurisdiction for a period of 
one-year to support law enforcement activity. To date, no records have 
been provided to Federal government organizations to support 
operational events; however, local jurisdiction record keeping is 
audited as part of the BioWatch Evaluation Program (BWEP) to monitor 
for system-wide problems and to ensure that written records are being 
maintained in accordance with BioWatch Program requirements.
    A personal digital assistant (PDA) is used to collect many of the 
data elements captured by the filter holder logs. However due to 
mechanical failure, possibility of spooking there is a need for 
redundancy in the form of paper copies.
    A personal digital assistant (PDA) based data collection system--
the BioWatch Sample Management System (SMS)--is used to collect 
electronic information related to sample management to support program 
operations and logistics. The SMS is a software system designed to 
track sample holders and other media from the time they are created, 
until they are delivered to the laboratory. The software monitors when 
the sample holder was assembled, deployed to the field, placed in the 
collector, removed from the collector, and delivered to the laboratory, 
along with who was responsible for each operation. The SMS software 
produces reports used by other software in the BioWatch system, such as 
the Centers for Disease Control Laboratory Results Messenger software. 
As directed by the FBI, a written record tied to each sample 
establishing chain of custody is to be created to support law 
enforcement activity; the FBI has informed the BioWatch Program of the 
determination that the electronic SMS cannot meet the FBI's evidence 
recording requirements.
    There has been an increase in the annual burden associated with 
this collection. This increase is due to more locations using the 
holder filter log on a daily basis. Previously there were 522 locations 
and now there are 605 locations. This has increased the number 
responses annually by 30,817 and the hours by 515. There is no change 
in the burden time per response. There is no change in the information 
being collection. However, there are proposed changes to DHS 9500, 
Filter Holder Log. These changes include:
     Repositioning of Filter Installation and Filter Removal 
Tables. Currently the tables are viewed (top to bottom) Filter 
Installation then Filter Removal. These tables have been repositioned 
to align with the actual sequence of events at the work site * * * 
there is removal of the old filter first followed by installation of 
the new filter.
     Site Name field changed to Number. This has been changed 
to comply with the BioWatch Standard Operation Procedure (SOP).
     Within the Filter Installation table under Physical 
Security Check, On Arrival data elements have been removed. These 
elements no longer need to be collected because it is already covered 
in the Filter Removal portion of the procedure.
     Within the Filter Removal and Filter Installation remove 
the word Collector and replace with PSU. This has been changed to 
reflect the type of collector, and its unique number.
    The Office of Management and Budget is particularly interested in 
comments which:
    1. Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    2. Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    3. Enhance the quality, utility, and clarity of the information to 
be collected; and
    4. Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submissions of responses.

Analysis

    Agency: Office of Health Affairs/OCMO Early Detection Division, 
DHS.
    Title: BioWatch Filter Holder Log.
    OMB Number: 1601-0006.
    Frequency: Daily.
    Affected Public: State, Local, and Tribal Governments.
    Number of Respondents: 605.
    Estimated Time per Respondent: 1 minute.
    Total Burden Hours: 3688 hours.

    Dated: July 18, 2013.
Margaret H. Graves,
Acting Chief Information Officer.
[FR Doc. 2013-17909 Filed 7-24-13; 8:45 am]
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