30-Day FRN CFATS DHS-2012-0059

16692

Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices

• In vivo data available (animal)
Inventors: Menghang Xia, Ruili
Huang, Christopher P. Austin (all of
NCATS).
Intellectual Property: HHS Reference
No. E–156–2012/0—US Application No.
61/692,560 filed 23 Aug 2012.
Licensing Contact: Sabarni Chatterjee,
Ph.D., MBA; 301–435–5587;
[email protected].
Collaborative Research Opportunity:
The National Center for Advancing
Translational Sciences, Division of PreClinical Innovation, is seeking
statements of capability or interest from
parties interested in collaborative
research to further develop, evaluate or
commercialize Combination
Chemotherapeutics for the Treatment of
Chordoma. For collaboration
opportunities, please contact Lili M.
Portilla, MPA at [email protected].
Dated: March 8, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
and Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–06070 Filed 3–15–13; 8:45 am]
BILLING CODE 4140–01–P

DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Prospective Grant of Start-Up Option
Exclusive License: The Development
of Liposomal Therapeutic Agents for
the Treatment of Human Epithelial
Cancers and Liposarcomas
National Institutes of Health,
Public Health Service, HHS.
ACTION: Notice.
AGENCY:

This is notice, in accordance
with 35 U.S.C. 209(c)(1) and 37 CFR
404.7(a)(1)(i), that the National
Institutes of Health, Department of
Health and Human Services, is
contemplating the grant to ZoneOne
Pharma, Inc., of an exclusive evaluation
option license to practice the inventions
embodied in the following US Patent
(and all foreign counterparts): Serial No.
6,890,917 entitled, ‘‘Geldanamycin
Derivative and Method of Treating
Cancer Using Same’’ [HHS Ref. E–050–
2000/0–US–15]. The patent rights in
this invention have been assigned to the
Government of the United States of
America.
The prospective exclusive evaluation
option license territory may be
worldwide, and the field of use may be
limited to:

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SUMMARY:

The pharmaceutical use in humans of 17dimethylaminoethylamino-17-

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demethoxygeldanamycin (‘‘17–DMAG’’) as a
liposome-encapsulated drug, alone or in
combination with other agents, for the
treatment of the following types of cancer:
ovary, pancreas, metastatic skin, head and
neck, colon, kidney, non-small cell lung, or
liposarcoma.

Dated: March 8, 2013.
Richard U. Rodriguez,
Director, Division of Technology Development
& Transfer, Office of Technology Transfer,
National Institutes of Health.
[FR Doc. 2013–06069 Filed 3–15–13; 8:45 am]
BILLING CODE 4140–01–P

Upon the expiration or termination of
the exclusive evaluation option license,
ZoneOne Pharma, Inc., will have the
exclusive right to execute an exclusive
commercialization license which will
supersede and replace the exclusive
evaluation option license with no
greater field of use and territory than
granted in the exclusive evaluation
option license.
Only written comments or
applications for a license (or both)
which are received by the NIH Office of
Technology Transfer on or before April
2, 2013 will be considered.

DATES:

Requests for copies of the
patent application, inquiries, comments,
and other materials relating to the
contemplated exclusive evaluation
option license should be directed to:
Patrick McCue, Ph.D., Licensing and
Patenting Manager, Office of
Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard,
Suite 325, Rockville, MD 20852–3804;
Telephone: (301) 435–5560; Facsimile:
(301) 402–0220; Email:
[email protected].

ADDRESSES:

This
invention concerns 17–DMAG, the first
water-soluble analog of 17–AAG, a less
toxic and more stable analog of the
antitumor antibiotic geldanamycin.
The prospective exclusive evaluation
license is being considered under the
small business initiative launched on 1
October 2011, and will comply with the
terms and conditions of 35 U.S.C. 209
and 37 CFR 404.7. The prospective
exclusive evaluation license, and a
subsequent exclusive commercialization
license, may be granted unless 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 404.7 within fifteen (15) days from
the date of this published notice.
Complete 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
evaluation option 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.

SUPPLEMENTARY INFORMATION:

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DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2012–0059]

Chemical Facility Anti-Terrorism
Standards (CFATS)
National Protection and
Programs Directorate, DHS.
ACTION: 30-day notice and request for
comments; Extension of Information
Collection Request: 1670–0014.
AGENCY:

The Department of Homeland
Security (DHS), National Protection and
Programs Directorate (NPPD), Office of
Infrastructure Protection (IP),
Infrastructure Security Compliance
Division (ISCD) 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). The Department previously
published this ICR in the Federal
Register on December 17, 2012, for a 60day public comment period.1 In this
notice, NPPD is responding to one
comment 2 and is soliciting public
comments concerning the extension of
Information Collection Request,
Chemical Facility Anti-Terrorism
Standards (CFATS) for an additional 30
days.
DATES: Comments are encouraged and
will be accepted until April 17, 2013.
This process is conducted in accordance
with 5 CFR 1320.10.
ADDRESSES: Interested persons are
invited to submit written comments on
the proposed information collection to
the Office of Information and Regulatory
Affairs, OMB. Comments should be
addressed to OMB Desk Officer,
Department of Homeland Security,
National Protection and Programs
Directorate. Comments must be
SUMMARY:

1 See 77 FR 74677. The 60-day Federal Register
notice for Information Collection 1670–0014, which
solicited comments for 60 days, may be found at
https://federalregister.gov/a/2012-30314.
2 The comment was submitted under docket #
DHS–2012–0059 and provided comment not only
on this information collection request (i.e., 1670–
0014), but also on ICR 1670–0007 and ICR 1670–
0015. The comment may be viewed at http://
www.regulations.gov/#!documentDetail;D=DHS2012-0059-0002.

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pmangrum on DSK3VPTVN1PROD with NOTICES

Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices
identified by docket number DHS–
2012–0059 and may be submitted by
one of the following methods:
Æ Federal eRulemaking Portal: http://
www.regulations.gov.
Æ Email:
[email protected]. Include
the docket number in the subject line of
the message.
Æ Fax: (202) 395–5806.
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and the docket
number for this action. Comments
received will be posted without
alteration at http://www.regulations.gov,
including any personal information
provided. Comments that include trade
secrets, confidential commercial or
financial information, Chemicalterrorism Vulnerability Information
(CVI), Sensitive Security Information
(SSI), or Protected Critical Infrastructure
Information (PCII) should not be
submitted to the public regulatory
docket. Please submit such comments
separately from other comments in
response to this notice. Comments
containing trade secrets, confidential
commercial or financial information,
CVI, SSI, or PCII should be
appropriately marked and submitted by
mail to the Office of Information and
Regulatory Affairs, OMB. Comments
should be addressed to OMB Desk
Officer, Department of Homeland
Security, National Protection and
Programs Directorate. Comments must
be identified by docket number DHS–
2012–0059.
OMB is particularly interested in
comments that:
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.
FOR FURTHER INFORMATION CONTACT:
CFATS Program Manager, DHS/NPPD/
IP/ISCD, [email protected].

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Section
550 of the Homeland Security
Appropriations Act of 2007, Public Law
109–295, provides DHS with the
authority to regulate the security of
high-risk chemical facilities. On April 9,
2007, the Department issued an Interim
Final Rule (IFR), implementing this
statutory mandate at 72 FR 17688.
Section 550 of the Homeland Security
Appropriations Act of 2007 requires a
risk-based approach to security.
CFATS is the Department’s
regulations under Section 550 governing
security at high-risk chemical facilities.
See 6 CFR part 27. CFATS represents a
national-level effort to minimize
terrorism risk to such facilities. Its
design and implementation balance
maintaining economic vitality with
security facilities and their surrounding
communities. In collaboration with the
private sector and other stakeholders,
the Department designed the regulations
to take advantage of protective measures
already in place and to allow facilities
to employ a wide range of tailored
measures to satisfy the regulations’ RiskBased Performance Standards (RBPS).
The instruments within this collection
will be used to manage the CFATS
program.
Response to Comment Submitted
During 60-Day Comment Period: The
Department received a comment
suggesting that in the 60-day notice, the
Department incorrectly calculated the
burden estimates associated with the
instrument ‘‘Request for a Technical
Correction.’’ The commenter assumed
that the number of responses per
respondent for this instrument was one.
In fact, the Department estimated in the
current Information Collection, which
expires on March 31, 2013, that each
respondent will on average respond 1.5
times. This assumption was carried over
into the burden estimates used by the
Department in the 60-day notice but not
made explicit. The total annual burden
for this instrument is calculated as
follows [0.25 hours x 185 respondents x
1.5 responses per respondent], which
equals 69.37 hours. The Department did
not revise the burden estimates for this
instrument.
Therefore, for this instrument and the
other instruments in this 30-day notice
the Department will continue to rely on
the analysis and resulting burden
estimates in the 60-day notice.

SUPPLEMENTARY INFORMATION:

Analysis
Agency: Department of Homeland
Security, National Protection and
Programs Directorate, Office of
Infrastructure Protection, Infrastructure
Security Compliance Division.

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16693

Title: Chemical Facility AntiTerrorism Standards (CFATS).
OMB Number: 1670–0014.
Instrument: Request for
Redetermination.
Frequency: On occasion/Other.
Affected Public: Business or other forprofit.
Number of Respondents: 625
respondents (estimate).
Estimated Time per Respondent: 0.25
hours.
Total Burden Hours: 156.25 annual
burden hours.
Total Burden Cost (capital/startup):
$0.
Total Recordkeeping Burden: $0.
Total Burden Cost (operating/
maintaining): $13,437.
Instrument: Request for an Extension.
Frequency: On occasion/Other.
Affected Public: Business or other forprofit.
Number of Respondents: 185
respondents (estimate).
Estimated Time per Respondent: 0.25
hours.
Total Burden Hours: 46.25 annual
burden hours.
Total Burden Cost (capital/startup):
$0.
Total Recordkeeping Burden: $0.
Total Burden Cost (operating/
maintaining): $3,977.
Instrument: Notification of a New Top
Screen.
Frequency: On occasion/Other.
Affected Public: Business or other forprofit.
Number of Respondents: 1250
respondents (estimate).
Estimated Time per Respondent: 0.25
hours.
Total Burden Hours: 468.75 annual
burden hours.
Total Burden Cost (capital/startup):
$0.
Total Recordkeeping Burden: $0.
Total Burden Cost (operating/
maintaining): $40,312.
Instrument: Request for a Technical
Consultation.
Frequency: On occasion/Other.
Affected Public: Business or other forprofit.
Number of Respondents: 185
respondents (estimate).
Estimated Time per Respondent: 0.25
hours.
Total Burden Hours: 69.37 annual
burden hours.
Total Burden Cost (capital/startup):
$0.
Total Recordkeeping Burden: $0.
Total Burden Cost (operating/
maintaining): $5,966.

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16694

Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices

Dated: March 11, 2013.
Michael Butcher,
Acting Chief Information Officer, National
Protection and Programs Directorate,
Department of Homeland Security.
[FR Doc. 2013–06097 Filed 3–15–13; 8:45 am]
BILLING CODE 9110–9P–P

DEPARTMENT OF HOMELAND
SECURITY
[Docket No. DHS–2012–0058]

Chemical Security Assessment Tool
(CSAT)
National Protection and
Programs Directorate, DHS.
ACTION: 30-day notice and request for
comments; Revision of Information
Collection Request: 1670–0007.
AGENCY:

The Department of Homeland
Security (DHS), National Protection and
Programs Directorate (NPPD), Office of
Infrastructure Protection (IP),
Infrastructure Security Compliance
Division (ISCD), 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). The Department previously
published this ICR in the Federal
Register on December 17, 2012, for a 60day public comment period.1 In this
notice NPPD is (1) responding to one
comment submitted in response to the
60-day notice previously published for
this ICR, (2) responding to an additional
comment that was responsive to
different notice, also published on
December 17, 2012, that solicited
comments on a related Information
Collection Request,2 and (3) soliciting
comments concerning the extension of
Information Collection Request,
Chemical Security Assessment Tool for
an additional 30 days for public
comments.
DATES: Comments are encouraged and
will be accepted until April 17, 2013.
This process is conducted in accordance
with 5 CFR 1320.10.
ADDRESSES: Interested persons are
invited to submit written comments on
pmangrum on DSK3VPTVN1PROD with NOTICES

SUMMARY:

1 See 77 FR 74678. The 60-day Federal Register
notice for Information Collection 1670–0007, which
solicited comments for 60 days, may be found at
https://federalregister.gov/a/2012-30313.
2 The comment was submitted under docket #
DHS–2012–0059 and provided comment not only
on this Information Collection Request (i.e., 1670–
0007), but also on ICR 1670–0014 and ICR 1670–
0015. The comment may be viewed at http://
www.regulations.gov/#!documentDetail;D=DHS2012-0059-0002.

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the proposed information collection to
the Office of Information and Regulatory
Affairs, OMB. Comments should be
addressed to OMB Desk Officer,
Department of Homeland Security,
National Protection and Programs
Directorate. Comments must be
identified by the docket number DHS–
2012–0058 and may be submitted by
one of the following methods:
Æ Federal eRulemaking Portal: http://
www.regulations.gov.
Æ Email:
[email protected]. Include
the docket number in the subject line of
the message.
Æ Fax: (202) 395–5806.
Instructions: All submissions received
must include the words ‘‘Department of
Homeland Security’’ and the docket
number for this action. Comments
received will be posted without
alteration at http://www.regulations.gov,
including any personal information
provided.
Comments that include trade secrets,
confidential commercial or financial
information, Chemical-terrorism
Vulnerability Information (CVI),
Sensitive Security Information (SSI), or
Protected Critical Infrastructure
Information (PCII) should not be
submitted to the public regulatory
docket. Please submit such comments
separately from other comments in
response to this notice. Comments
containing trade secrets, confidential
commercial or financial information,
CVI, SSI, or PCII should be
appropriately marked and submitted by
mail to the Office of Information and
Regulatory Affairs, OMB. Comments
should be addressed to OMB Desk
Officer, Department of Homeland
Security, National Protection and
Programs Directorate. Comments must
be identified by docket number DHS–
2012–0058.
OMB is particularly interested in
comments that:
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,

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electronic, mechanical, or other
technological collection techniques or
other forms of information technology,
e.g., permitting electronic submissions
of responses.
FOR FURTHER INFORMATION CONTACT:
CFATS Program Manager, DHS/NPPD/
IP/ISCD, [email protected].
SUPPLEMENTARY INFORMATION: Section
550 of the Homeland Security
Appropriations Act of 2007, Public Law
109–295 (2006), provides DHS with the
authority to regulate the security of
high-risk chemical facilities. On April 9,
2007, the Department issued an Interim
Final Rule (IFR), implementing this
statutory mandate at 72 FR 17688.
Section 550 of the Homeland Security
Appropriations Act of 2007 requires a
risk-based approach to security.
The Chemical Facility Anti-Terrorism
Standards (CFATS) are the Department’s
regulations under Section 550 governing
security at high-risk chemical facilities.
See 6 CFR part 27. CFATS represents a
national-level effort to minimize
terrorism risk to such facilities. Its
design and implementation balance
maintaining economic vitality with
securing facilities and their surrounding
communities. The regulations were
designed, in collaboration with the
private sector and other stakeholders, to
take advantage of protective measures
already in place and to allow facilities
to employ a wide range of tailored
measures to satisfy the regulations’ RiskBased Performance Standards (RBPS).
The Department collects the core
regulatory data through the portions of
the Chemical Security Assessment Tool
(CSAT) covered under this collection.
For more information about CFATS and
CSAT, you may access www.dhs.gov/
chemicalsecurity. The current
information collection for these portions
of CSAT will expire on March 31, 2013.
Response to Comments Submitted
During the 60-Day Comment Period
The Department received two
comments in response to the Federal
Register notices published on December
17, 2012. One comment requested that
the Department correct a citation in one
of its user guides but did not comment
on the Department’s Paperwork
Reduction Act burden estimates. The
Department has made available on its
Web site (www.dhs.gov/
chemicalsecurity) updated materials
that contain the correct citation.3
3 The commenter requested that the Department
correct a citation in DHS Form 9007 (version 1.3).
The Department has made available on its Web site
version 2.8 of DHS Form 9007 which contains the
correct citation.

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