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Federal Register / Vol. 74, No. 236 / Thursday, December 10, 2009 / Notices
SEND was developed by the Clinical
Data Interchange Standards
Consortium’s (CDISC’s) SEND Team.
CDISC is an open, multidisciplinary,
nonprofit organization that has
established worldwide industry
standards to support the electronic
acquisition and submission of clinical
trial data and metadata for medical and
biopharmaceutical product
development (http://www.cdisc.org1).
CDISC is currently facilitating and
testing the extension of the same SEND
standard for nonclinical toxicology data.
Where possible, the standards
developed for clinical datasets and
metadata, as described in the overall
Study Data Tabulation Model (SDTM),
are being used to develop a
standardized dataset format for
nonclinical studies.
Recently, the Center for Drug
Evaluation and Research (CDER)
completed a pilot project (phase 1)
using the SEND format in sample
toxicology datasets, that is, outside of a
regulatory setting (68 FR 3885, January
27, 2003). The phase 1 CDER pilot also
evaluated data validation and analysis
tools specifically designed to validate
datasets according to the current SEND
standard and to enable a reviewer to
display and evaluate data efficiently
from animal toxicity studies submitted
in the SEND format. The phase 1 pilot
resulted in the development of a SEND
Implementation Guide (SENDIG)
describing the process for formatting
data from single- and repeat-dose
animal toxicity and carcinogenicity
studies for submission purposes.
Following the phase 1 pilot, CDER
announced a second pilot (phase 2) to
test SEND formatted datasets in a
regulatory setting (72 FR 56363, October
3, 2007). To support the new CDER
pilot, the SENDIG has been updated to
ensure the harmonized implementation
of the CDISC SDTM and SEND models.
The updated guide can be found at
http://www.cdisc.org.
CVM currently receives margin of
safety and nonclinical toxicology study
data in paper, portable document format
(PDF), and other electronic formats. The
lack of uniformity in the formats used
by sponsors to submit data, in addition
to the inconsistent use of terminology
across submissions, complicates the
agency’s efforts to validate, display, and
evaluate the data using modern,
computer-based review and analysis
tools. As part of FDA’s effort to
modernize its information technology
1 FDA has verified the Web site address, but FDA
is not responsible for any subsequent changes to the
Web site address after this document publishes in
the Federal Register.

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systems and improve efficiency, CVM is
planning to transition to a true
electronic data format for submission of
study data for regulatory review.
II. Pilot Project Description
This pilot is intended to help CVM
evaluate the adequacy of the current
SEND format (SAS transport files, XPT
version 5) in accommodating margin of
safety and nonclinical toxicology study
data submitted to the Center. As part of
this evaluation and in anticipation of
FDA receiving datasets for regulatory
review, the CDISC SEND Team, in
collaboration with FDA and available
pilot participants, will first update the
SENDIG as needed to include
veterinary-specific data elements and
terms.
As experience from the ongoing pilot
is gained with various types of margin
of safety and nonclinical toxicology
study data, CVM expects to recommend
new technical specifications for margin
of safety and toxicology studies as part
of a continuing process of transitioning
from paper-based submissions to the
submission of study data by electronic
means.
III. Participation
CVM is seeking a limited number of
sponsors (approximately five to eight,
but no more than eight) to participate in
this pilot. Because a limited group of
voluntary participants is needed, CVM
will use its discretion in choosing
volunteers, based on their experience
with datasets previously submitted to
CVM. The duration of the pilot is
expected to be approximately 3 years,
but it may be extended as needed. A
familiarity with SEND (e.g., from
involvement in the CDER pilot) would
benefit participants but is not necessary
for participation in the project. A
participant should be willing to provide
the same study data in both paper
format and SEND electronic format
using SAS transport files (XPT version
5). The pilot provides the best
opportunity to compare and evaluate
the same data available in paper and
SEND formats in order to test the
accuracy and reliability of the SEND
format.
For the purposes of this pilot, study
reports from margin of safety and
nonclinical toxicology study data will
be requested for submission. We
anticipate that a successful pilot,
including the implementation of any
needed changes to the SENDIG and/or
the data validation, viewing, and
analysis tools, will allow CVM to accept
specific types of margin of safety and
nonclinical toxicology study data

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electronically based on the SEND
format.
Requests to participate in the pilot
project should be submitted to the
Division of Dockets Management (see
ADDRESSES). Requests are to be
identified with the docket number
found in brackets in the heading of this
document.
Under current FDA regulations,
applicants must provide evidence to
establish safety and effectiveness as part
of their NADA (21 CFR 514.1(b)(8)).
Participation in this pilot program will
not exempt participants from
compliance with applicable
requirements for the submission of
evidence to establish safety and
effectiveness.
IV. Comments
Interested persons may submit to the
Division of Dockets Management (see
ADDRESSES) electronic or written
comments regarding this pilot project.
Submit a single copy of electronic
comments or two paper copies of any
mailed comments, except that
individuals may submit one paper copy.
Comments are to be identified with the
docket number found in brackets in the
heading of this document. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
Dated: December 4, 2009.
David Horowitz,
Assistant Commissioner for Policy.
[FR Doc. E9–29419 Filed 12–9–09; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Federal Emergency Management
Agency
[Docket ID: FEMA–2009–0001]

Agency Information Collection
Activities: Proposed Collection;
Comment Request, 1660–0105;
Community Preparedness and
Participation Survey
AGENCY: Federal Emergency
Management Agency, DHS.
ACTION: Notice; 60-day notice and
request for comments; revision of a
currently approved information
collection; OMB No. 1660–0105; 088–0–
2, Household Preparedness Telephone
Survey.
SUMMARY: The Federal Emergency
Management Agency, as part of its
continuing effort to reduce paperwork
and respondent burden, invites the

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Federal Register / Vol. 74, No. 236 / Thursday, December 10, 2009 / Notices

general public and other Federal
agencies to take this opportunity to
comment on a proposed extension,
without change, of a currently approved
information collection. In accordance
with the Paperwork Reduction Act of
1995, this Notice seeks comments
concerning the Community
Preparedness and Participation Survey,
a telephone survey that collects
preparedness information from the
general population.
DATES: Comments must be submitted on
or before February 8, 2010.
ADDRESSES: To avoid duplicate
submissions to the docket, please use
only one of the following means to
submit comments:
(1) Online. Submit comments at
http://www.regulations.gov under
docket ID FEMA–2009–0001. Follow the
instructions for submitting comments.
(2) Mail. Submit written comments to
Office of Chief Counsel, Regulation and
Policy Team, DHS/FEMA, 500 C Street,
SW., Room 835, WASH, DC 20472–
3100.
(3) Facsimile. Submit comments to
(703) 483–2999.
(4) E-mail. Submit comments to
[email protected]. Include docket
ID FEMA–2009–0001 in the subject line.
All submissions received must include
the agency name and docket ID.
Regardless of the method used for
submitting comments or material, all
submissions will be posted, without
change, to the Federal eRulemaking
Portal at http://www.regulations.gov,

and will include any personal
information you provide. Therefore,
submitting this information makes it
public. You may wish to read the
Privacy Act notice that is available on
the Privacy and Use Notice link on the
Administration Navigation Bar of
http://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT:
Contact Jenelle Gabriele, Program
Specialist, Community Preparedness
Division at 202–786–9463 for additional
information. You may contact the
Records Management Branch for copies
of the proposed collection of
information at facsimile number (202)
646–3347 or e-mail address: [email protected].
SUPPLEMENTARY INFORMATION: This
survey will allow the Federal
Emergency Management Agency
(FEMA) to collect information that
reports the state of citizen preparedness
in the United States. FEMA’s
Community Preparedness Division
administers Citizen Corps, an initiative
launched by President George W. Bush
in Executive Order 13254 in January
2002. Citizen Corps’ mission is to bring
together government and community
leaders to involve citizens in all-hazards
emergency preparedness and resilience.
To evaluate the Nation’s progress on
personal preparedness, FEMA’s
Community Preparedness Division
conducts National surveys to measure
the public’s knowledge, attitudes, and
behaviors relative to preparing for a
range of hazards. This information

collection enables Citizen Corps
Councils and other community based
organizations to improve upon their
strategies to enhance preparedness
programs and disaster response.
Collection of Information
Title: Community Preparedness and
Participation Survey.
Type of Information Collection:
Revision of a currently approved
information collection.
OMB Number: OMB No. 1660–0105.
Form Titles and Numbers: FEMA
Form 088–0–2, Household Preparedness
Telephone Survey.
Abstract: FEMA’s Community
Preparedness Division would like to
renew a currently approved collection
to evaluate the state of preparedness
nationally. The Community
Preparedness Division analyzes the data
collected through this telephone survey
of the public to identify progress and
gaps in citizen and community
preparedness and participation. This
information is used by the Community
Preparedness Division, and Citizen
Corps Councils to tailor awareness and
recruitment campaigns, messaging and
public information efforts, and strategic
planning initiatives to more effectively
improve the state of citizen
preparedness and participation across
the country.
Affected Public: Individuals or
households.
Estimated Total Annual Burden
Hours: 3,247 hours.

TABLE A.12—ESTIMATED ANNUALIZED BURDEN HOURS AND COSTS
Type of
respondent

Form name/form
number

Individuals or
households.

Total ..............

Number of
respondents
9,750

1

9,750

.............................

9,750

....................

....................

Comments

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Total Number of responses

Household Preparedness Telephone Survey/
FEMA Form
088–0–2.

Estimated Cost: None.

Comments may be submitted as
indicated in the ADDRESSES caption
above. Comments are solicited to (a)
evaluate whether the proposed data
collection is necessary for the proper
performance of the agency, including
whether the information shall have
practical utility; (b) evaluate the
accuracy of the agency’s estimate of the
burden of the proposed collection of

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Number of
responses
per respondent

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Avg. burden
per response
(in hours)

Total annual
burden
(in hours)

Avg. hourly
wage rate*

Total annual
respondent
cost

20 minutes
(.333
hours).

3,247

$21.80

$70,784.60

......................

3,247

....................

70,784.60

information, including the validity of
the methodology and assumptions used;
(c) enhance the quality, utility, and
clarity of the information to be
collected; and (d) 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 submission of
responses.

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Dated: December 4, 2009.
Samuel C. Smith,
Acting Director, Records Management
Division, Office of Management, Federal
Emergency Management Agency, Department
of Homeland Security.
[FR Doc. E9–29448 Filed 12–9–09; 8:45 am]
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