60-day notice

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Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Notices

Cancer
immunotherapy is a recent approach
where tumor associated antigens
(TAAs), which are primarily expressed
in human tumor cells, and not
expressed or minimally expressed in
normal tissues, are employed to
generate a tumor-specific immune
response. Specifically, these antigens
serve as targets for the host immune
system and elicit responses that result
in tumor destruction.
The initiation of an effective T-cell
immune response to antigens requires
two signals. The first one is antigenspecific via the peptide/major
histocompatibility complex and the
second or ‘‘costimulatory’’ signal is
required for cytokine production,
proliferation, and other aspects of T-cell
activation.
The patents and patent applications
describe a vaccine technology, TRICOM,
in conjunction with tumor associated
antigens (TAAs). The TRICOM
technology employs avirulent
poxviruses to present a combination of
costimulatory signaling molecules with
tumor-associated antigens (TAAs) to
activate T-cells and break the immune
systems tolerance towards cancer cells.
This is achieved using recombinant
poxvirus DNA vectors that encode both
T-cell costimulatory molecules and
TAAs. The combination of the three (3)
costimulatory molecules B7.1, ICAM–1
and LFA–3, hence the name TRICOM,
has been shown to have more than the
additive effect of each costimulatory
molecule when used individually to
optimally activate both CD4+ and CD8+
T cells. When a TRICOM based vaccine
expressing TAAs is administered it
greatly enhances the immune response
against the malignant cells expressing
those TAAs. The addition of the two
well-known TAAs, carcinoembryonic
antigen (CEA) and MUC–1 to the
TRICOM vector results in the PANVAC
vaccine, which is used in a prime and
boost vaccine strategy. It is well
established that the over-expression of
these two (2) TAAs are associated with
the presence of a variety of carcinomas;
including colorectal cancer and
therefore PANVAC can potentially be an
effective cancer vaccine for colorectal
cancer. Additionally, new tumor
associated antigens can also be used
with TRICOM to develop novel
vaccines. For example, Brachyury, well
known for its role in developmental cell
biology and recently been implicated in
tumor cell invasion and metastasis, has
been shown to be aberrantly expressed
in several tumors including colorectal
tumors. As a result, Brachyury is being
used as a tumor associated antigen along
with TRICOM and has potential as a

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SUPPLEMENTARY INFORMATION:

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cancer immunotherapeutic vaccine for
the treatment of several tumors
including colorectal cancer.
The prospective exclusive license will
be royalty bearing and will comply with
the terms and conditions of 35 U.S.C.
209 and 37 CFR Part 404.7. The
prospective exclusive license may be
granted unless within thirty (30) days
from the date of this published notice,
the NIH receives written evidence and
argument that establishes that the grant
of the license would not be consistent
with the requirements of 35 U.S.C. 209
and 37 CFR Part 404.7.
Applications for a license in the field
of use filed in response to this notice
will be treated as objections to the grant
of the contemplated exclusive license.
Comments and objections submitted to
this notice will not be made available
for public inspection and, to the extent
permitted by law, will not be released
under the Freedom of Information Act,
5 U.S.C. 552.
Dated: May 23, 2012.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2012–13006 Filed 5–29–12; 8:45 am]
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DEPARTMENT OF HOMELAND
SECURITY
Transportation Security Administration
Intent To Request Approval From OMB
of One New Public Collection of
Information: Baseline Assessment for
Security Enhancement (BASE)
Program for Public Transportation
Systems
Transportation Security
Administration, DHS.
ACTION: 60-day Notice.
AGENCY:

The Transportation Security
Administration (TSA) invites public
comment on a new Information
Collection Request (ICR) abstracted
below that we will submit to the Office
of Management and Budget (OMB) for
approval in compliance with the
Paperwork Reduction Act (PRA). The
ICR describes the nature of the
information collection and its expected
burden. This voluntary collection
allows TSA to conduct transportation
security-related assessments during site
visits with security and operating
officials of transit agencies.
DATES: Send your comments by July 30,
2012.
ADDRESSES: Comments may be emailed
to [email protected] or delivered to the
SUMMARY:

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TSA PRA Officer, Office of Information
Technology (OIT), TSA–11,
Transportation Security Administration,
601 South 12th Street, Arlington, VA
20598–6011.
FOR FURTHER INFORMATION CONTACT:
Susan Perkins at the above address, or
by telephone (571) 227–3398.
SUPPLEMENTARY INFORMATION:
Comments Invited
In accordance with the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501
et seq.), an agency may not conduct or
sponsor, and a person is not required to
respond to, a collection of information
unless it displays a valid OMB control
number. The ICR documentation is
available at www.reginfo.gov. Therefore,
in preparation for OMB review and
approval of the following information
collection, TSA is soliciting comments
to—
(1) Evaluate whether the proposed
information requirement 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;
(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 using
appropriate automated, electronic,
mechanical, or other technological
collection techniques or other forms of
information technology.
Information Collection Requirement
Purpose of Data Collection
Approximately 6,000 transit service
providers, commuter railroads, and long
distance passenger railroad providers
operate in the United States.1 Mass
transit and passenger rail systems
provide transportation services through
buses, rail transit, commuter rail, longdistance rail, and other, less common
types of service (cable cars, inclined
planes, funiculars, and automated
guideway systems). These systems can
also include ‘‘demand response
services’’ for seniors and persons with
disabilities, as well as vanpool/
rideshare programs and taxi services
operated under contract with a public
transportation agency.
TSA is required to ‘‘assess the
security of each surface transportation
mode and evaluate the effectiveness and
efficiency of current Federal
Government surface transportation
1 TSA, ‘‘Transportation Sector-Specific Plan Mass
Transit Modal Annex’’, page 4 (May 2007).

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Federal Register / Vol. 77, No. 104 / Wednesday, May 30, 2012 / Notices
security initiatives.’’ E.O. 13416, sec.
3(a) (Dec. 5, 2006). While many transit
systems have security and emergency
response plans or protocols in place, no
single database exists, nor is there a
consistent approach to evaluating the
extent to which security programs are in
place across public transportation
systems.
TSA developed the Baseline
Assessment for Security Enhancement
(BASE) program for public
transportation systems to evaluate the
status of security and emergency
response programs throughout the
nation.2 In particular, a BASE review
assesses the security measures of public
transportation systems and gathers data
used by TSA to address its
responsibilities, such as evaluating
‘‘effectiveness and efficiency of current
Federal Government surface
transportation security initiatives’’ and
developing modal specific annexes to
the Transportation Systems Sector
Specific Plan that include ‘‘an
identification of existing security
guidelines and requirements and any
security gaps * * *’’ E.O. 13416, sec.
3(c)(i). Reflecting its risk-based
prioritization, TSA primarily conducts
BASE reviews on the top 100 transit
systems in the country, as identified by
the Federal Transit Administration
(FTA).3

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Description of Data Collection
TSA’s Surface Transportation
Security Inspectors (STSIs) conduct
BASE reviews during site visits with
security and operating officials of transit
and passenger rail systems. The STSIs
capture and document relevant
information using a standardized
electronic checklist. Advance
coordination and planning ensures the
efficiency of the assessment process. As
part of this, transit and passenger rail
systems may also obtain a checklist in
advance from TSA and conduct selfassessments of their security readiness.
All BASE reviews are done on a
voluntary basis.
The BASE checklist guides the
collection of information and
encompasses review of security plans,
programs, and procedures employed by
transit and passenger rail systems in
implementing the recommended TSA/
FTA Security and Emergency
Management Action Items for Transit
2 A separate program within TSA also conducts
BASE reviews to assess security measures related to
highway transportation, notice of which will be
published separately in the Federal Register.
3 A current list of the top 100 transit systems can
be viewed on the National Transit Database Web
site at http://www.ntdprogram.gov/ntdprogram/.

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Agencies (Action Items).4 During a
review, STSIs collect information from
the review of transit and passenger rail
system documents, plans, and
procedures; interviews with appropriate
public transportation agency personnel,
to gain process insight; and system
observations prompted by questions
raised during the document review and
interview stages. TSA subject matter
experts can then analyze this
information. If information in
completed assessments meets the
requirements of 49 CFR parts 15 and
1520, which would mean that
disclosure of the information would be
detrimental to the security of
transportation, TSA will designate and
mark the data as ‘‘Sensitive Security
Information,’’ and protect it in
accordance with the requirements set
forth in those regulations.
Use of Results
A BASE review evaluates a public
transportation agency’s security
program components using a twophased approach: (1) Field collection of
information, and (2) analysis/evaluation
of collected information. The
information collected by TSA through
BASE reviews strengthens the security
of transit and passenger rail systems by
supporting security program
development (including grant
programs), and the analysis/evaluation
provides a consistent road map for
transit and passenger rail systems to
address security and emergency
program vulnerabilities. In addition, a
public transportation system that
undergoes a BASE assessment review is
provided with a report of results that
can be used by the system to identify
and prioritize vulnerabilities to enhance
security.
Specifically, the information collected
will be used as follows:
1. To develop a baseline
understanding of a public transportation
agency’s security and emergency
management processes, procedures,
policies, programs, and activities against
security requirements and
recommended security practices
published by TSA and FTA.
2. To enhance a public transportation
agency’s overall security posture
through collaborative review and
discussion of existing security activities,
identification of areas of potential
weakness or vulnerability, and
development of remedial
recommendations and courses of action.

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3. To identify programs and protocols
implemented by a public transportation
agency that represent an ‘‘effective’’ or
‘‘smart’’ security practice warranting
sharing with the transit and passenger
rail community as a whole to foster
general enhancement of security in the
mass transit and passenger rail mode.
4. To inform TSA’s development of
security strategies, priorities, and
programs for the most effective
application of available resources,
including funds distributed under the
Transit Security Grant Program, to
enhance security in the Nation’s transit
and passenger rail systems.
While TSA has not set a limit on the
number of public transportation system
BASE program reviews to conduct, TSA
estimates it will conduct approximately
100 public transportation system BASE
reviews on an annual basis and does not
intend to conduct more than one BASE
review per transit or passenger rail
system in a single year. The total hour
burden dedicated to the assessment and
collection of security-related documents
for review varies depending upon the
size of the system and scope of its
security program and activities. The
hours estimated represent a sampling of
BASE reviews completed in 2010. The
sampling was derived from 15 public
transportation agencies varying in size
from small to large. Actual inspection
hours were utilized in the sampling.
TSA estimates that the hour burden per
public transportation agency to engage
its security and/or operating officials
with inspectors in the interactive BASE
program review process is
approximately 18 hours for a small
public transportation agency,
approximately 144 hours for a large
public transportation agency, and
approximately 46 hours for a
moderately-sized agency. Thus, the total
annual hour burden for the BASE
program review (140 agencies
identified) is estimated on the low end
of 2520 hours (140 x 18 = 2520)
annually and the high end of 6440 hours
(140 x 46 = 6440) annually. This
number will most likely increase as
additional public transportation
agencies volunteer to participate.
Issued in Arlington, Virginia, on May 23,
2012.
Susan Perkins,
TSA Paperwork Reduction Act Officer, Office
of Information Technology.
[FR Doc. 2012–12959 Filed 5–29–12; 8:45 am]

4 Action

Items are available for download at
http://www.tsa.gov/assets/pdf/
mass_transit_action_items.pdf.

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