16692 Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices 

1See 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. 

2The 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. 

• 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; 

chatterjeesa@mail.nih.gov. 

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 lilip@nih.gov. 

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 

AGENCY: National Institutes of Health, 

Public Health Service, HHS. 

ACTION: Notice. 

SUMMARY: 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: 

The pharmaceutical use in humans of 17- 

dimethylaminoethylamino-17- 

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. 

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. 

DATES: 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. 

ADDRESSES: 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: 

mccuepat@mail.nih.gov. 

SUPPLEMENTARY INFORMATION: 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. 

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 

DEPARTMENT OF HOMELAND 

SECURITY 

[Docket No. DHS–2012–0059] 

Chemical Facility Anti-Terrorism 

Standards (CFATS) 

AGENCY: National Protection and 

Programs Directorate, DHS. 

ACTION: 30-day notice and request for 

comments; Extension of Information 

Collection Request: 1670–0014. 

SUMMARY: 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 60- 

day 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 


pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices 16693 

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: 

oira_submission@omb.eop.gov. 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, CFATS@hq.dhs.gov. 

SUPPLEMENTARY INFORMATION: 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. 

Analysis 

Agency: Department of Homeland 

Security, National Protection and 

Programs Directorate, Office of 

Infrastructure Protection, Infrastructure 

Security Compliance Division. 

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. 


pmangrum on DSK3VPTVN1PROD with NOTICES
16694 Federal Register / Vol. 78, No. 52 / Monday, March 18, 2013 / Notices 

1See 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. 

2The 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. 

3The 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. 

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) 

AGENCY: National Protection and 

Programs Directorate, DHS. 

ACTION: 30-day notice and request for 

comments; Revision of Information 

Collection Request: 1670–0007. 

SUMMARY: 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 60- 

day 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 

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: 

oira_submission@omb.eop.gov. 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, 

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, CFATS@hq.dhs.gov. 

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


pmangrum on DSK3VPTVN1PROD with NOTICES