13404 Federal Register / Vol. 76, No. 48 / Friday, March 11, 2011 / Notices 

This application is used by insurance 

brokers to register with Export Import 

Bank. The application provides Export 

Import Bank staff with the information 

necessary to make a determination of 

the eligibility of the broker to receive 

commission payments under Export 

Import Bank’s credit insurance 

programs. 

We have revised the following 

question: ‘‘Indicate (Not Required) if 

owned by a woman or an ethnic 

minority, describe’’ 

To this question: 

‘‘Is the majority ownership of your 

business represented by: women or 

minority?’’ 

This form can be reviewed at http:// 

www.exim.gov/pub/pending/EIB 92_79 

Broker Registration Form. 

DATES: Comments should be received on 

or before May 10, 2011 to be assured of 

consideration. 

ADDRESSES: Comments maybe submitted 

through http://www.Regulations.Gov or 

mailed to Judith Rivera, Export Import 

Bank of the United States, 811 Vermont 

Ave., NW. Washington, DC 20571 

SUPPLEMENTARY INFORMATION: Titles and 

Form Number: EIB 92–79 Broker 

Registration Form. 

OMB Number: 3048–0024. 

Type of Review: Regular. 

Need and Use: This application is 

used by insurance brokers to register 

with Export Import Bank. The 

application provides Export Import 

Bank staff with the information 

necessary to make a determination of 

the eligibility of the broker to receive 

commission payments under Export 

Import Bank’s credit insurance 

programs. 

Affected Public: This form affects 

entities involved in the export of U.S. 

goods and services. 

Annual Number of Respondents: 50. 

Estimated Time per Respondent: 100 

hours. 

Government Annual Burden Hours: 

200 hours. 

Frequency of Reporting or Use: Once. 

Sharon A. Whitt, 

Agency Clearance Officer. 

[FR Doc. 2011–5598 Filed 3–10–11; 8:45 am] 

BILLING CODE 6690–01–P 

FEDERAL DEPOSIT INSURANCE 

CORPORATION 

Sunshine Act Meeting 

Pursuant to the provisions of the 

‘‘Government in the Sunshine Act’’ (5 

U.S.C. 552b), notice is hereby given that 

the Federal Deposit Insurance 

Corporation’s Board of Directors will 

meet in open session at 10 a.m. on 

Tuesday, March 15, 2011, to consider 

the following matters: 

Summary Agenda: No substantive 

discussion of the following items is 

anticipated. These matters will be 

resolved with a single vote unless a 

member of the Board of Directors 

requests that an item be moved to the 

discussion agenda. 

Disposition of minutes of previous 

Board of Directors’ Meetings. 

Summary reports, status reports, and 

reports of actions taken pursuant to 

authority delegated by the Board of 

Directors. 

Memorandum and resolution re: Final 

Rule Making Technical Amendments 

to FDIC’s Anti-Money-Laundering 

Program and Fair Credit Reporting 

Rules to Update Cross-References to 

Treasury Regulations. 

Memorandum and resolution re: 

Authorization to Publish Privacy Act 

System of Records Notice in the 

Federal Register. 

Discussion Agenda 

Memorandum and resolution re: Notice 

of Proposed Rulemaking regarding 

Priorities and Claims Process under 

the Orderly Liquidation Authority 

Provisions of the Dodd-Frank Wall 

Street Reform and Consumer 

Protection Act. 

The meeting will be held in the Board 

Room on the sixth floor of the FDIC 

Building located at 550 17th Street, 

NW., Washington, DC. 

This Board meeting will be Webcast 

live via the Internet and subsequently 

made available on-demand 

approximately one week after the event. 

Visit http://www.vodium.com/goto/fdic/ 

boardmeetings.asp to view the event. If 

you need any technical assistance, 

please visit our Video Help page at: 

http://www.fdic.gov/video.html. 

The FDIC will provide attendees with 

auxiliary aids (e.g., sign language 

interpretation) required for this meeting. 

Those attendees needing such assistance 

should call 703–562–2404 (Voice) or 

703–649–4354 (Video Phone) to make 

necessary arrangements. 

Requests for further information 

concerning the meeting may be directed 

to Mr. Robert E. Feldman, Executive 

Secretary of the Corporation, at 202– 

898–7043. 

Dated: March 8, 2011. 

Robert E. Feldman, 

Executive Secretary, Federal Deposit 

Insurance Corporation. 

[FR Doc. 2011–5730 Filed 3–9–11; 4:15 pm] 

BILLING CODE P 

FEDERAL ELECTION COMMISSION 

Sunshine Act Notice 

AGENCY: Federal Election Commission. 

DATE AND TIME: Wednesday, March 16, 

2011 at 10 a.m. 

PLACE: 999 E Street, NW., Washington, 

DC (Ninth Floor). 

STATUS: This meeting will be open to the 

public. 

Items To Be Discussed 

Correction and Approval of the Minutes 

for the Meeting of March 3, 2011 

Draft Advisory Opinion 2011–03: 

Democratic Senatorial Campaign 

Committee, National Republican 

Congressional Committee, Republican 

National Committee, Democratic 

Congressional Campaign Committee, 

and National Republican Senatorial 

Committee by Marc E. Elias, Esq., 

Jessica Furst, Esq., John Phillippe, 

Esq., Brian G. Svoboda, Esq., and 

Michael E. Toner, Esq. 

Proposed Final Audit Report on Hillary 

Clinton for President (A08–05) 

Withdrawal and Resubmission of 

Proposed Interpretative Rule 

Regarding Electronic Contributor 

Redesignations (LRA 820) 

Legislative Recommendations 

Management and Administrative 

Matters. 

Individuals who plan to attend and 

require special assistance, such as sign 

language interpretation or other 

reasonable accommodations, should 

contact Shawn Woodhead Werth, 

Commission Secretary and Clerk, at 

(202) 694–1040, at least 72 hours prior 

to the hearing date. 

PERSON TO CONTACT FOR INFORMATION: 

Judith Ingram, Press Officer, Telephone: 

(202) 694–1220. 

Shawn Woodhead Werth, 

Secretary and Clerk of the Commission. 

[FR Doc. 2011–5846 Filed 3–9–11; 4:15 pm] 

BILLING CODE 6715–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Cancer Therapy Evaluation Program 

Intellectual Property Option to 

Collaborator 

AGENCY: National Institutes of Health, 

HHS. 

ACTION: Notice. 

SUMMARY: The National Cancer Institute, 

Division of Cancer Treatment and 

Diagnosis, is announcing the final 

revision of the NCI Cancer Therapy 

Evaluation Program’s Intellectual 

Property Option to Collaborator. 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 48 / Friday, March 11, 2011 / Notices 13405 

SUPPLEMENTARY INFORMATION: In the 

Federal Register of April 6, 2010 (FR 

Vol. 65, No. 65), the National Cancer 

Institute, Division of Cancer Treatment 

and Diagnosis (DCT) issued a proposed 

revision to the Cancer Therapy 

Evaluation Program (CTEP)’s 

Intellectual Property Option to 

Collaborator. The proposed revision 

represents a major effort on the part of 

NCI CTEP to address the disposition of 

intellectual property (IP) related to data 

and Agent-treated specimens in studies 

where CTEP provides agents, as well as 

to harmonize the IP terms with 

standards currently used by the cancer 

research community. The background 

and description of the rationale can be 

found in the Background Section of the 

proposed revision issued April 6, 2010. 

The proposal called for submission of 

comments by May 6th, 2010. NCI CTEP 

received numerous comments in 

response to the proposed revision, many 

of which asserted that the proposed 

change would not meet its stated goals 

and requested NCI CTEP to reevaluate 

specific aspects of the proposal. CTEP 

agreed with some of these comments 

and has revised selected aspects of the 

proposed CTEP Intellectual Property 

Option to Collaborator to better reflect 

our stated goals. 

I. Rationale for the Changes to the IP 

Option 

The Cancer Therapy Evaluation 

Program (CTEP) of the National Cancer 

Institute’s (NCI) Division of Cancer 

Treatment and Diagnosis (DCTD) 

obtains proprietary ‘‘Agents’’ from 

biotechnology and pharmaceutical 

companies (hereinafter ‘‘Collaborators’’) 

for use in NCI-supported clinical trials 

under funding agreements. As part of 

the arrangement with these 

Collaborators to use their proprietary 

Agents and to make conducting such 

clinical research possible, Collaborators 

will often require, as a condition of 

collaboration, that the NCI funded 

recipients receiving the Agent 

(‘‘Institutions’’) agree to certain 

conditions, including the willingness to 

provide notice of and grant options to 

certain intellectual property rights 

arising from research involving the 

Agent under the scope of an NCI 

funding agreement. The IP Option will 

apply to inventions generated from 

clinical studies for which CTEP 

provided Agent(s) and for inventions 

generated under any other NCI CTEPapproved studies that use CTEPprovided Agent(s), non-publicly 

released clinical data or Agent(s)-treated 

specimens from those clinical studies. 

The previous IP option language was 

silent as to the disposition of 

intellectual property developed from 

data and Agent-treated samples. As a 

result, both Collaborators and 

Institutions claimed an ownership 

interest in inventions generated from 

these data and materials. This lack of 

clarity has become a major impediment 

in NCI CTEP’s ability to obtain 

proprietary Agents from collaborators 

for use in NCI CTEP-sponsored clinical 

studies. This has resulted in delays and 

threatens the continuing ability of CTEP 

to provide proprietary Agents to NCIfunded investigators for important 

clinical studies to advance the treatment 

of cancer. The lack of Agents for these 

clinical studies jeopardizes NCI CTEP’s 

ability to support these research 

activities. The revised CTEP IP Option 

and Institution Notification is intended 

to offer appropriate incentives and 

assurance for both Collaborators and 

Institutions to participate in CTEPsponsored clinical studies. 

II. The Proposed Revision to the CTEP 

Intellectual Property Option to the 

Collaborator 

The following is the proposed 

revision to the CTEP IP Option that was 

published in the Federal Register on 

April 6th: 

The Cancer Therapy Evaluation 

Program (CTEP) of the National Cancer 

Institute’s (NCI) Division of Cancer 

Treatment and Diagnosis (DCTD) 

obtains ‘‘Agents’’ from biotechnology 

and pharmaceutical companies 

(hereinafter ‘‘Collaborators’’) through 

Cooperative Research and Development 

Agreements (‘‘CRADAs’’) and other 

means, for use in NCI-funded research 

conducted via extramural funding 

agreements. As part of the arrangement 

with these Collaborators to use their 

Agents and to make the collaborative 

research possible, NCI CTEP would 

agree not to provide Agents to 

Institutions unless they provide 

Collaborators with the IP Options and 

Institution Notifications described 

below. The specific terms of the IP 

Options depend on the types of 

inventions that arise out of the NCI 

CTEP funded research (Section A 

Inventions, Section B Inventions, or 

Unauthorized Inventions). NCI CTEP is 

requesting applicants include 

assurances of agreement with the terms 

of the IP Options and Institutional 

Notification described below in their 

funding applications to NCI CTEP. 

References to ‘‘Institution’’ mean the 

funding recipient conducting the 

research described herein. The 

Intellectual Property Options (IP 

Options) and Institution Notification 

described below will apply to 

inventions arising from research 

involving the Agent(s) under the scope 

of an NCI CTEP funding agreement. 

A. The IP Option described in this 

Section A would apply to inventions 

that use or incorporate the Agent(s) and 

that are conceived or first actually 

reduced to practice pursuant to NCI 

CTEP-funded clinical or non-clinical 

studies utilizing the Agent(s) (‘‘Section 

A Inventions’’): 

Institution agrees to grant 

Collaborator(s): (i) A royalty-free, 

worldwide, non-exclusive license for 

commercial purposes; and (ii) a time 

limited first option to negotiate an 

exclusive, or co-exclusive, if applicable, 

world-wide, royalty bearing license for 

commercial purposes, including the 

right to grant sub licenses, subject to any 

rights of the Government of the United 

States of America, on terms to be 

negotiated in good faith by the 

Collaborator(s) and Institution. If 

Collaborator accepts the non-exclusive 

commercial license, the Collaborator 

agrees to pay all out of pocket patent 

prosecution and maintenance costs 

which will be pro-rated and divided 

equally among all licensees. If 

Collaborator obtains an exclusive 

commercial license, in addition to any 

other agreed upon licensing 

arrangements such as royalties and due 

diligence requirements, the Collaborator 

agrees to pay all out of pocket patent 

prosecution and maintenance costs. 

Collaborator(s) will notify Institution, in 

writing, if it is interested in obtaining a 

commercial license to any Section A 

Invention within three (3) months of 

Collaborator’s receipt of a patent 

application or six (6) months of receipt 

of an invention report notification of 

such Section A Invention. In the event 

Collaborator fails to so notify 

Institution, or elects not to obtain an 

exclusive license, then Collaborator’s 

option expires with respect to that 

Section A Invention, and Institution 

will be free to dispose of its interests in 

accordance with its policies. If 

Institution and Collaborator fail to reach 

agreement within ninety (90) days, (or 

such additional period as Collaborator 

and Institution may agree) on the terms 

for an exclusive license for a particular 

Section A Invention, then for a period 

of three (3) months thereafter Institution 

agrees not to offer to license the Section 

A Invention to any third party on 

materially better terms than those last 

offered to Collaborator without first 

offering such terms to Collaborator, in 

which case Collaborator will have a 

period of thirty (30) days in which to 

accept or reject the offer. If Collaborator 

elects to negotiate an exclusive 

commercial license to a Section A 

Invention, then Institution agrees to file 


srobinson on DSKHWCL6B1PROD with NOTICES
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and prosecute patent application(s) 

diligently and in a timely manner and 

to give Collaborator an opportunity to 

comment on the preparation and filing 

of any such patent application(s). 

Notwithstanding the above, Institution 

is under no obligation to file or maintain 

patent prosecution for any Section A 

Invention. 

For all Section A Inventions, 

regardless of Collaborator’s decision to 

seek a commercial license, Institution 

agrees to grant Collaborator a paid-up, 

nonexclusive, royalty-free, world-wide 

license for research purposes only. 

Institution retains the right to make and 

use any Section A Invention for all nonprofit research, including for 

educational purposes and to permit 

other educational and non-profit 

institutions to do so. 

B. The IP Option described in this 

Section B would apply to inventions 

that do not use or incorporate the 

Agent(s) but that are conceived or first 

actually reduced to practice pursuant to 

NCI CTEP clinical or non-clinical 

studies utilizing the Agent(s). It also 

applies to inventions that are conceived 

or first actually reduced to practice 

pursuant to NCI CTEP studies utilizing 

clinical data or specimens from patients 

treated with the Agent (including 

specimens obtained from NCI CTEPfunded tissue banks) (‘‘Section B 

Inventions’’): 

Institution agrees to grant to 

Collaborator(s): (i) A paid-up 

nonexclusive, nontransferable, royaltyfree, world-wide license to all Section B 

Inventions for research purposes only; 

(ii) a time-limited first option to 

negotiate a non-exclusive, exclusive, or 

co-exclusive, if applicable, world-wide 

royalty-bearing license for commercial 

purposes, including the right to grant 

sub-licenses, subject to any rights of the 

Government of the United States of 

America, on terms to be negotiated in 

good faith by the Collaborator(s) and 

Institution; and (iii) a nonexclusive, 

royalty-free, world-wide license either 

to (a) disclose Section B Inventions to a 

regulatory authority when seeking 

marketing authorization of the Agent, or 

(b) disclose Section B Inventions on a 

product insert or other promotional 

material regarding the Agent after 

having obtained marketing 

authorization from a regulatory 

authority. Collaborator will notify 

Institution, in writing, of its interest in 

obtaining an exclusive commercial 

license to any Section B Invention 

within one year of Collaborator’s receipt 

of a patent application or eighteen 

months of receipt of an invention report 

notifying Collaborator of such Section B 

Invention(s). In the event that 

Collaborator fails to so notify 

Institution, or elects not to obtain an 

exclusive license, then Collaborator’s 

option expires with respect to that 

Section B Invention, and Institution will 

be free to dispose of its interests in such 

Section B Invention in accordance with 

Institution’s policies. If Institution and 

Collaborator fail to reach agreement 

within ninety (90) days, (or such 

additional period as Collaborator and 

Institution may agree) on the terms for 

an exclusive license for a particular 

Subject B Invention, then for a period of 

six (6) months thereafter Institution 

agrees not to offer to license the Section 

B Invention to any third party on 

materially better terms than those last 

offered to Collaborator without first 

offering such terms to Collaborator, in 

which case Collaborator will have a 

period of thirty (30) days in which to 

accept or reject the offer. Institution 

retains the right to make and use any 

Section B Inventions for all non-profit 

research, including for educational 

purposes and to permit other 

educational and non-profit institutions 

to do so. If Collaborator elects to 

negotiate an exclusive commercial 

license to a Section B Invention, then 

Institution agrees to file and prosecute 

patent application(s) diligently and in a 

timely manner and to give Collaborator 

an opportunity to comment on the 

preparation and filing of any such 

patent application(s). Notwithstanding 

the above, Institution is under no 

obligation to file or maintain patent 

prosecution for any Section B Invention. 

Inventions arising more than five 

years after the release of data on the 

primary end point of the NCI CTEP 

clinical trial that generated the clinical 

data and/or specimens will not be 

subject to the Section B(ii) IP Option. 

C. The IP Option described in this 

Section C would apply to inventions 

made by Institution’s investigator(s) or 

any other employees or agents of 

Institution, which are or may be 

patentable or otherwise protectable, as a 

result of research utilizing the Agent(s) 

outside the scope of the NCI CTEP 

funding agreement (Unauthorized 

Inventions): 

Institution agrees, at Collaborator’s 

request and expense, to grant to 

Collaborator a royalty-free exclusive or 

co-exclusive license to Unauthorized 

Inventions. 

D. Institution Notification 

Institution agrees to promptly notify 

NCI CTEP (NCICTEPpubs@mail.nih.gov) 

and Collaborator(s) in writing of any 

Section A Inventions, Section B 

Inventions, and Unauthorized 

Inventions upon the earlier of: (i) Any 

submission of any invention disclosure 

to Institution of a Section A, Section B, 

or Unauthorized Invention, or (ii) the 

filing of any patent applications of a 

Section A, Section B, or Unauthorized 

Invention. Institution agrees to provide 

a copy of either the invention disclosure 

or the patent application to the 

Collaborator and to NCI CTEP which 

will treat it in accordance with 37 CFR 

part 401. These requirements do not 

replace any applicable reporting 

requirements under the Bayh-Dole Act, 

35 U.S.C. 200–212, and implementing 

regulations at 37 CFR part 401. 

III. Comments on the Proposed 

Revision and NCI CTEP’s Response and 

Modifications to the Proposed Option 

Based on Feedback 

The NCI CTEP received 24 responses 

to the proposed revision to the CTEP 

Intellectual Property Option. Comments 

were received from pharmaceutical and 

biotechnology companies, diagnostic 

companies, industry groups, the 

cooperative groups, universities, 

hospitals and the Council on 

Government Relations. 

To make it easier to identify 

comments and our responses, the word 

‘‘Comment’’ in parentheses, appears 

before the comment’s description and 

the word ‘‘Response,’’ in parentheses, 

appears before our response. Similar 

comments are grouped together under 

the same number. Due to the detail of 

some responses as well as space and 

time limitations, we will not address 

every point brought up by every 

Commenter, but will focus on major 

concerns expressed by a variety of 

Commenter’s and the issues that were 

addressed in the final version of the 

CTEP IP Option. We have condensed 

some responses into topic areas, 

especially areas where there were a 

wide range of conflicting suggestions. 

The number assigned to each comment 

is purely for organizational purposes 

and does not signify the comment’s 

value or importance or the order in 

which it was received. For ease of use 

comments will be divided by Section 

and follow a generalized order of the 

proposed Option itself: 

1. Overall Scope of the IP Option and 

Situations in Which the IP Option 

Would Be Applied 

(Comment) A recurring issue among 

many respondents was that the 

document itself was unclear as to the 

scope of the IP Option, specifically to 

which studies the IP Option must be 

applied. 

(Response) NCI has endeavored to 

properly clarify the scope in the final 

revision. The NCI CTEP IP option will 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 48 / Friday, March 11, 2011 / Notices 13407 

apply to inventions generated from: (a) 

Clinical studies for which CTEP 

provided Agent(s), (b) other NCI CTEPapproved studies that use CTEP– 

Provided Agent(s), and (c) non-publicly 

released clinical data or Agent(s)-treated 

specimens from those clinical studies. 

2. The Definition of Inventions, Was too 

Vague and Ambiguous in Both Sections 

A and B 

(Comment) Many respondents from 

all groups commented that the 

definition of inventions as those that 

‘‘use or incorporate’’ Agent was too 

vague. Several respondents offered 

suggestions as to language that would 

clarify the intended meaning and 

narrow the scope. 

(Response) NCI concurs that this 

language was vague, and in the final 

Option has modified the language to 

more appropriately clarify the scope. 

The final Option replaces ‘‘use or 

incorporates’’ with the statement that 

the Option will apply to ‘‘inventions 

that would be described in patent 

disclosures that claim the use and/or the 

composition of the Agent(s).’’ 

3. Invention Language Should State 

That the Scope Should Cover Inventions 

That Are ‘‘Conceived AND Reduced to 

Practice’’ Under the Clinical Studies as 

Opposed to ‘‘Conceived OR Reduced to 

Practice’’ 

(Comment) Several respondents 

suggested altering this language based 

on the following reasoning: While this 

language is consistent with the BayhDole Act scope of ‘‘subject inventions’’ 

for Federal funding purposes, Bayh-Dole 

only speaks to the rights to inventions 

provided to funding recipients and the 

government. The IP option, however 

applies to rights that funding recipients 

grant to third party Collaborators, 

therefore the Bayh-Dole scope does not 

apply to theses inventions. Since the 

Bayh-Dole scope does not apply this 

language should not be considered. Use 

of ‘‘OR’’ language was purported to have 

substantial risk to create conflicting 

obligations, as the Collaborator would 

have rights to prior conceptions (that are 

reduced to practice under the clinical 

study) and future reductions to practice 

(of conceptions made under this clinical 

study). This would require institutions 

to carefully monitor and possibly 

restrict other agreements and funding 

related to follow on research. 

(Response) NCI CTEP finds this 

argument unpersuasive. While it may 

not be necessary to apply the Bayh-Dole 

scope to the inventions covered under 

this Option, NCI CTEP feels that there 

is value in maintaining a consistent 

standard that reflects the intent of BayhDole. This language is also consistent 

with the terms offered to collaborators 

under Federal Cooperative Research and 

Development Agreements. More 

importantly this change would be 

inconsistent with programmatic policy 

and the manner in which clinical 

studies are reviewed and approved. 

Many of the clinical study proposals are 

in response to an NCI CTEP-solicitation 

that has been formulated with the 

Collaborator so it would be difficult for 

the investigator to have ‘‘conceived’’ the 

invention. However, the investigator 

could be the first to ‘‘reduce it to 

practice.’’ ‘‘Conceived or reduced to 

practice’’ benefits the investigators 

submitting unsolicited proposals since, 

even if the Collaborator disapproved a 

proposal, the investigator would still 

have ‘‘conceived’’ the invention. 

In regards to future reductions to 

practice, NCI CTEP wants to reinforce 

that the Section A is only applicable to 

studies wherein CTEP provides Agent, 

which limits the application of this 

clause sufficiently that future reductions 

are not a concern. If an Institution is 

utilizing NCI CTEP provided agent, any 

invention generated is by definition not 

a future reduction to practice, but rather 

part of an ongoing study. 

4. The Section A and B Licenses Should 

be an Assignment of all Intellectual 

Property (Including Copyright and 

Trademarks) to the Collaborator, With 

an Offer to Provide an Automatic NonExclusive Research Use License Back to 

the Inventing Institution 

(Comment) Several respondents felt 

that an outright assignment of all 

intellectual property to collaborators 

would provide a better incentive for 

participation in NCI CTEP clinical 

studies. 

(Response) NCI believes that while 

this would provide greater incentives 

for participation on the part of Industry, 

such assignment would have a chilling 

effect on the participation of academic 

researchers and on the business model 

of downstream diagnostic companies. In 

addition, NCI CTEP feels that the rights 

offered in the CTEP IP Option should 

pertain solely to patents. 

5. The Section A Non-Exclusive Royalty 

Free Commercialization License Should 

be Sub-Licensable 

(Comment) Several respondents felt 

that the Section A non-exclusive license 

needed to be sub-licensable in order to 

have any real value. In today’s market 

place, collaborators often partner with 

several other entities when undertaking 

development efforts, so the nonexclusive license is effectively worthless 

without the ability to sub-license. 

(Response) NCI believes that there is 

merit to this position; however we are 

cognizant that an unfettered right to 

sub-license would destroy all value for 

inventing institutions. NCI CTEP has 

included new language indicating that 

the Section A license is sublicensable, 

however it may only be sub-licensed to 

affiliates or Collaborators for the 

purposes of development. 

6. Patent Expenses Related to all 

Licensing Options 

(Comment) There were several 

distinct and competing views in the 

comments related to the disposition of 

patent expenses. Some respondents felt 

that it was inappropriate for the 

Institutions to receive reimbursement of 

any patent expenses for non exclusive 

licenses. Conversely, other respondents 

felt that the Option should clearly state 

that the Collaborator is responsible for 

all patent expenses, including expenses 

associated with the exclusive licensing 

option. 

(Response) NCI believes that the 

proposed IP option strikes an 

appropriate balance in regards to patent 

expenses. Since the proposed option 

represents an expansion of rights 

relative to the current option, NCI 

believes it is entirely appropriate for 

Collaborators to shoulder patent 

expenses (in a pro-rated manner) if they 

wish to exercise their option to the 

NERF or the Exclusive licensing option 

in Section A. If Collaborator is not 

interested in shouldering patent 

expenses related to Section A 

inventions, they are in no way obligated 

to and will still receive a research use 

license. 

In regard to Section B inventions, NCI 

CTEP feels that the granted licenses are 

sufficiently narrow in scope and 

consistent with the free research use 

license of Section A. NCI CTEP will 

remain silent in regard to any exclusive 

or non-exclusive licenses that parties 

may wish to negotiate in addition to the 

licenses described in this section. The 

Institution and the Collaborator are in 

the best position to determine the most 

appropriate terms for an exclusive or a 

non exclusive license on any Section B 

invention, should they decide to 

negotiate such a license. While it is a 

standard convention in exclusive 

licensing negotiations for the licensee to 

cover the cost of patents, there may be 

instances, particularly with regard to 

smaller companies participating in the 

program, where it would be to the 

benefit of both the Institution and the 

Collaborator to have the flexibility to 

negotiate other licensing terms. 


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7. Time Frames On Negotiation of 

Section A Exclusive Licensing Options 

as Well as Most-Favored Nation Period 

(Comment) This was an area of broad 

discussion where comments varied 

substantially based on the position of 

the commenter. In general Industry 

responders felt the time period for 

negotiation and most favored nation 

status was too short, and asked for a 

time frame double what the proposed 

Option provided. Arguments focused on 

the difficulty of properly valuating the 

IP in such a short time frame. 

Conversely, Institutions and diagnostic 

company respondents felt the time 

frame for negotiation was too long, and 

that the most favored nation provisions 

should be removed entirely. Arguments 

focused on the delay that these terms 

engender and the ability of a 

Collaborator to use them to ‘‘halt’’ 

development of associated technologies. 

(Response) NCI believes that the 

current time frame for negotiation of 

Section A inventions appropriately 

balances the concerns expressed by both 

Collaborators and Institutions. While 

neither side is completely satisfied with 

the time frames, they are consistent with 

previous policy, and our experience 

indicates they are at the very least 

functional. 

8. Section B Inventions: Clarity 

Regarding the Scope of Data to Which 

the Option Will Apply 

(Comment) Several respondents felt 

that the description of data in Section B 

was ambiguous and overly broad, and 

that it could be interpreted to apply to 

data that had been published or had 

otherwise entered the public domain. 

(Response) NCI CTEP agrees that the 

language in this Section B pertaining to 

data required more clarity. We have 

added language specifying that it only 

applies to confidential data from 

clinical studies that used NCI CTEPprovided Agent or data from such 

studies that has not yet been published. 

The Option is not intended to read on 

publicly available or published data. 

9. Section B(ii) Inventions (ii): Exclusive 

Licensing Option 

(Comment) In general the inclusion of 

the Section B(ii) exclusive licensing 

option was the source of greatest 

controversy within the proposed 

Option. Institutions and diagnostic 

company respondents felt strongly that 

the proposed B(ii) exclusive licensing 

option: 

a. Was overly broad and included 

reach-through that would stifle the 

development of Inventions that are 

critical to the treatment of cancer 

patients. In particular the Option would 

make it difficult, if not impossible, for 

diagnostic companies to develop 

companion diagnostics to a particular 

treatment in a timely manner. 

b. Had time frames for negotiation of 

these licenses that were overly generous 

and needed to be reduced. 

c. Should not have a 5 year time 

limitation as this was both overly long 

and logistically impractical to 

implement. 

d. Was fundamentally unfair, would 

constrain the ability of Institutions to 

collaborate on diagnostics, and thus, it 

would have a chilling effect on 

participation in CTEP studies. 

(Response) NCI believes that 

Institution, and particularly Diagnostic 

company respondents made a 

compelling argument for the removal of 

this clause from the proposed option. 

The NCI’s goal in promulgating the 

revision was to encourage participation 

in CTEP studies by ensuring that 

Collaborators receive enough rights to 

protect their ability to successfully 

manufacture and commercially market 

any therapeutic they supply to the CTEP 

program (freedom to operate). 

The NCI believes that freedom to 

operate is protected by the more 

narrowly tailored Section B(iii) option, 

and that the B(ii) option as presented in 

the proposed option is overbroad and 

unnecessary to achieve NCI’s goals. In 

response, the NCI has removed the 

Section B(ii) option in its entirety from 

the final Option. 

10. Section B(iii) Inventions Use of 

‘‘and’’ Instead of ‘‘or’’ 

(Comment) Several respondents felt 

that it was unclear whether 

Collaborators would receive both the 

right to use Invention data for regulatory 

purposes and the right to include 

Invention data on product insert 

information. 

(Response) NCI agrees that this 

language was unnecessarily vague. The 

intent was for Collaborator to have both 

rights and as such the wording has been 

amended to replace ‘‘or’’ with ‘‘and.’’ 

11. Section C Inventions: 

Recommendations That the NCI Remain 

Silent on Unauthorized Inventions 

(Comment) Several respondents felt 

that that section was unduly harsh and 

should be removed altogether, with any 

action regarding unauthorized use to be 

left for the parties to resolve. 

Respondents also felt that this language 

may be in conflict with the Bayh-Dole 

Act. 

(Response) The NCI finds this 

argument unpersuasive. The removal of 

this section would effectively make it 

more attractive to develop an invention 

outside the scope of approved studies 

than under the scope and would 

provide a strong incentive for 

participants to breach the agreement. 

The NCI feels that there must be some 

form of penalty for breaching the 

agreement in order to maintain our 

ability to obtain proprietary Agents for 

clinical studies. 

In regards to Bayh-Dole, NCI has 

discussed this with our legal counsel at 

OGC. These unauthorized studies are, 

by definition, not done under the scope 

of a government funding agreement (the 

party is in fact in breach of a 

government funding agreement) 

therefore Bayh-Dole does not apply to 

these inventions. This language 

provides consequences in the event that 

a party steps outside of the agreed upon 

scope of work. 

12. Section C Inventions: 

Recommendation That the NCI include 

a Non-Exclusive Research Use License 

Back to the Inventing Institution 

(Comment) Several respondents felt 

that while the unauthorized use 

language was appropriate, the 

institution should retain a license to use 

any inventions generated, including 

those through unauthorized use, for 

internal research purposes. 

(Response) The NCI believes that this 

argument has merit and has included 

this language in the final Option. While 

we do not believe it is appropriate for 

Institutions to benefit from misuse of 

Agent, data or Agent-treated samples, 

we feel that we also have an obligation 

to support the scientific endeavor and 

avoid blocking important research in the 

case of inadvertent breach. 

IV. The Final Revision to the CTEP IP 

Option 

The following is the revision in its 

final form, with alterations made based 

on comments received to the April 6th 

Federal Register notice: 

The Cancer Therapy Evaluation 

Program (CTEP) of the National Cancer 

Institute’s (NCI) Division of Cancer 

Treatment and Diagnosis (DCTD) 

obtains ‘‘Agents’’ from biotechnology 

and pharmaceutical companies 

(hereinafter ‘‘Collaborators’’) through 

Cooperative Research and Development 

Agreements (‘‘CRADAs’’) and other 

means, for use in NCI-funded research 

conducted via extramural funding 

agreements. As part of the arrangement 

with these Collaborators to use their 

Agents and to make the collaborative 

research possible, NCI CTEP would 

agree not to provide Agents to 

Institutions unless they provide 

Collaborators with the IP Options and 


srobinson on DSKHWCL6B1PROD with NOTICES
Federal Register / Vol. 76, No. 48 / Friday, March 11, 2011 / Notices 13409 

Institution Notifications described 

below. The specific terms of the IP 

Option depend on the types of 

inventions that arise out of the studies 

wherein Agent is supplied by NCI CTEP 

pursuant to an agreement with a 

Collaborator (Section A Inventions, 

Section B Inventions, or Unauthorized 

Inventions). NCI CTEP is requesting that 

applicants include assurances of 

agreement with the terms of the IP 

Options and Institutional Notification 

described below in applicable funding 

applications to NCI. 

References to ‘‘Institution’’ mean the 

funding recipient conducting the 

research described herein. The 

Intellectual Property Options (IP 

Options) and Institution Notification 

described below will apply to 

inventions arising from research 

involving the Agent(s) under the scope 

of an NCI funding agreement. 

A. The IP Option described in this 

Section A would apply to inventions 

that would be described in patent 

disclosures that claim the use and/or 

the composition of the Agent(s) and that 

are conceived or first actually reduced 

to practice pursuant to clinical or nonclinical studies utilizing the NCI CTEP 

provided Agent(s) (‘‘Section A 

Inventions’’): 

Institution agrees to grant to 

Collaborator(s): (i) a royalty-free, 

worldwide, non-exclusive license for 

commercial purposes with the right to 

sub license to affiliates or collaborators 

working on behalf of Collaborator for 

Collaborator’s development purposes; 

and (ii) a time limited first option to 

negotiate an exclusive, or co-exclusive, 

if applicable, world-wide, royalty 

bearing license for commercial 

purposes, including the right to grant 

sub licenses, subject to any rights of the 

Government of the United States of 

America, on terms to be negotiated in 

good faith by the Collaborator(s) and 

Institution. If Collaborator accepts the 

non-exclusive commercial license, the 

Collaborator agrees to pay all out-ofpocket patent prosecution and 

maintenance costs which will be prorated and divided equally among all 

licensees. If Collaborator obtains an 

exclusive commercial license, in 

addition to any other agreed upon 

licensing arrangements such as royalties 

and due diligence requirements, the 

Collaborator agrees to pay all out-ofpocket patent prosecution and 

maintenance costs. Collaborator(s) will 

notify Institution, in writing, if it is 

interested in obtaining a commercial 

license to any Section A Invention 

within three (3) months of 

Collaborator’s receipt of a patent 

application or six (6) months of receipt 

of an invention report notification of 

such a section A invention. In the event 

that Collaborator fails to so notify 

Institution, or elects not to obtain an 

exclusive license, then Collaborator’s 

option expires with respect to that 

Section A Invention, and Institution 

will be free to dispose of its interests in 

accordance with its policies. If 

Institution and Collaborator fail to reach 

agreement within ninety (90) days, (or 

such additional period as Collaborator 

and Institution may agree) on the terms 

for an exclusive license for a particular 

Section A Invention, then for a period 

of three (3) months thereafter Institution 

agrees not to offer to license the Section 

A Invention to any third party on 

materially better terms than those last 

offered to Collaborator without first 

offering such terms to Collaborator, in 

which case Collaborator will have a 

period of thirty (30) days in which to 

accept or reject the offer. If Collaborator 

elects to negotiate an exclusive 

commercial license to a Section A 

Invention, then Institution agrees to file 

and prosecute patent application(s) 

diligently and in a timely manner and 

to give Collaborator an opportunity to 

comment on the preparation and filing 

of any such patent application(s). 

Notwithstanding the above, Institution 

is under no obligation to file or maintain 

patent prosecution for any Section A 

Invention. 

For all Section A Inventions, 

regardless of Collaborator’s decision to 

seek a commercial license, Institution 

agrees to grant Collaborator a paid-up, 

nonexclusive, royalty-free, world-wide 

license for research purposes only. 

Institution retains the right to make and 

use any Section A Invention for all nonprofit research, including for 

educational purposes and to permit 

other educational and non-profit 

institutions to do so. 

B. The IP Option described in this 

Section B would apply to inventions not 

covered by Section A, but are 

nevertheless conceived or first actually 

reduced to practice pursuant to clinical 

or non-clinical studies utilizing the 

CTEP-provided Agent(s). It also applies 

to inventions that are conceived or first 

actually reduced to practice pursuant to 

NCI CTEP-approved studies that use 

non-publicly available clinical data or 

specimens from patients treated with 

the CTEP-provided Agent (including 

specimens obtained from NCI CTEPfunded tissue banks) (‘‘Section B 

Inventions’’): 

Institution agrees to grant to 

Collaborator(s): (i) a paid-up 

nonexclusive, nontransferable, royaltyfree, world-wide license to all Section B 

Inventions for research purposes only; 

and (ii) a nonexclusive, royalty-free, 

world-wide license to (a.) disclose 

Section B Inventions to a regulatory 

authority when seeking marketing 

authorization of the Agent, and (b.) 

disclose Section B Inventions on a 

product insert or other promotional 

material regarding the Agent after 

having obtained marketing 

authorization from a regulatory 

authority. Notwithstanding the above, 

Institution is under no obligation to file 

or maintain patent prosecution for any 

Section B Invention. 

C. The IP Option described in this 

Section C would apply to inventions 

made by Institution’s investigator(s) or 

any other employees or agents of 

Institution, which are or may be 

patentable or otherwise protectable, as a 

result of research utilizing the CTEPprovided Agent(s), unreleased or nonpublicly available clinical data or Agent 

treated specimens outside the scope of 

approval granted by the NCI CTEP 

(Unauthorized Inventions): 

Institution agrees, at Collaborator’s 

request and expense, to grant to 

Collaborator a royalty-free exclusive or 

co-exclusive license to Unauthorized 

Inventions. Institution will retain a nonexclusive, non-sub-licensable royalty 

free license to practice the invention for 

research use purposes. 

D. Institution Notification 

Institution agrees to promptly and 

confidentially notify NCI CTEP 

(NCICTEPpubs@mail.nih.gov) and 

Collaborator(s) in writing of any Section 

A Inventions, Section B Inventions, and 

Unauthorized Inventions upon the 

earlier of: (i) Any submission of any 

invention disclosure to Institution of a 

Section A, Section B, or Unauthorized 

Invention, or (ii) the filing of any patent 

applications of a Section A, Section B, 

or Unauthorized Invention. Institution 

agrees to provide a copy of either the 

invention disclosure or the patent 

application to the Collaborator and to 

NCI CTEP which will treat it in 

accordance with 37 CFR Part 401. These 

requirements do not replace any 

applicable reporting requirements under 

the Bayh-Dole Act, 35 U.S.C. 200–212, 

and implementing regulations at 37 CFR 

part 401. 

V. Conclusion 

NCI and NIH would like to offer our 

thanks to all respondents for their 

articulate and well thought out 

comments, and their willingness to 

participate in this process. 


srobinson on DSKHWCL6B1PROD with NOTICES
13410 Federal Register / Vol. 76, No. 48 / Friday, March 11, 2011 / Notices 

Dated: March 8, 2011. 

Jeffrey Abrams, 

Associate Director, Cancer Therapy 

Evaluation Program, Division of Cancer 

Treatment and Diagnosis, National Cancer 

Institute. 

[FR Doc. 2011–5609 Filed 3–10–11; 8:45 am] 

BILLING CODE 4140–01–P 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Agency for Healthcare Research and 

Quality 

Agency Information Collection 

Activities: Proposed Collection; 

Comment Request 

AGENCY: Agency for Healthcare Research 

and Quality, HHS. 

ACTION: Notice. 

SUMMARY: This notice announces the 

intention of the Agency for Healthcare 

Research and Quality (AHRQ) to request 

that the Office of Management and 

Budget (OMB) approve the proposed 

information collection project: ‘‘Pilot 

Test of the Proposed Pharmacy Survey 

on Patient Safety Culture.’’ In 

accordance with the Paperwork 

Reduction Act, 44 U.S.C. 3501–3521, 

A1–IRQ invites the public to comment 

on this proposed information collection. 

DATES: Comments on this notice must be 

received by May 10, 2011. 

ADDRESSES: Written comments should 

be submitted to: Doris Lefkowitz, 

Reports Clearance Officer, AHRQ, by email at doris.lefkowitz@AHRQ.hhs.gov. 

Copies of the proposed collection 

plans, data collection instruments, and 

specific details on the estimated burden 

can be obtained from the AHRQ Reports 

Clearance Officer. 

FOR FURTHER INFORMATION CONTACT: 

Doris Lefkowitz, AHRQ Reports 

Clearance Officer, (301) 427–1477, or by 

e-mail at 

doris.lefkowitz@AHRQ.hhs.gov. 

SUPPLEMENTARY INFORMATION: 

Proposed Project 

Pilot Test of the Proposed Pharmacy 

Survey on Patient Safety Culture 

As the baby boomer population ages, 

the general U.S. population continues to 

grow, and as drug therapies for the 

treatment of chronic diseases become 

more efficacious, the expected increase 

in the number of prescriptions and 

demand for pharmaceutical products is 

likely to increase the potential for 

medication errors in community/retail 

pharmacies. In 2007, there were about 

56,000 community/retail pharmacies, 

including about 22,000 traditional chain 

pharmacy companies, nearly 17,000 

independent drug stores, about 9,300 

supermarket pharmacies, and about 

7,700 mass merchant pharmacies. 

Numerous reports substantiate the 

presence of medication errors in 

pharmacies. For example, one national 

observational study of prescription 

dispensing accuracy and safety in 50 

pharmacies in the U.S. found a rate of 

about 4 errors per day in a pharmacy 

filling 250 prescriptions daily. This 

error rate translates to an estimated 51.5 

million errors occurring during the 

filling of 3 billion prescriptions each 

year. 

Given the widespread impact of 

pharmacies on patient safety, the new 

Pharmacy Survey on Patient Safety 

Culture (Pharmacy SOPS) will measure 

pharmacy staff perceptions about what 

is important in their organization and 

what attitudes and behaviors related to 

patient safety are supported, rewarded, 

and expected. The survey will help 

community/retail pharmacies to identify 

and discuss strengths and weaknesses of 

patient safety culture within their 

individual pharmacies. They can then 

use that knowledge to develop 

appropriate action plans to improve 

their practices and their culture of 

patient safety. This survey is designed 

for use in community/retail pharmacies, 

which includes chain drugstores (e.g., 

Walgreens and CVS), supermarket 

pharmacies, independently owned 

pharmacies, and mass merchant 

pharmacies (e.g., Wal-Mart, Costco, 

Target), not for use in hospital 

pharmacies. 

This research has the following goals: 

(1) Cognitively test and modify as 

necessary the Pharmacy Survey on 

Patient Safety Culture Questionnaire; 

(2) Pretest and modify the 

questionnaire as necessary; 

(3) Make the final questionnaire 

available to the public. 

This study is being conducted by 

AHRQ through its contractor, Westat, 

pursuant to AHRQ’s statutory authority 

to conduct and support research on 

healthcare and on systems for the 

delivery of such care, including 

activities with respect to the quality, 

effectiveness, efficiency, 

appropriateness and value of healthcare 

services and with respect to quality 

measurement and improvement. 42 

U.S.C. 299a(a)(1) and (2). 

Method of Collection 

To achieve the goals of this study the 

following activities and data collections 

will be implemented: 

(1) Cognitive interviews—Two rounds 

of interviews will be conducted by 

telephone with 10 respondents each. 

The purpose of these interviews is to 

refine the questionnaire’s items and 

composites. Each round will be 

conducted with a mix of pharmacists 

and non-pharmacist staff working in 

community/retail pharmacies 

throughout the U.S. The same interview 

guide will be used for each round. 

(2) Pretest—The draft questionnaire 

will be pretested with all pharmacy staff 

in approximately 60 community/retail 

pharmacies. The purpose of the pretest 

is to collect data for an assessment of 

the reliability and construct validity of 

the survey’s items and composites, 

allowing for their further refinement. 

(3) Pharmacy background 

questionnaire—This questionnaire will 

be completed by the pharmacy manager 

in each of the 60 pretest sites to provide 

background characteristics of the 

pharmacy, such as pharmacy type 

(independently owned or chain), type of 

chain (traditional drugstore, 

supermarkets, mass merchant), average 

number of prescriptions filled weekly, 

average number of hours the pharmacy 

is open on weekdays, etc. 

(4) Dissemination activities—The final 

questionnaire will be made available to 

the public through the AHRQ Web site. 

This activity does not impose a burden 

on the public and is therefore not 

included in the burden estimates in 

Exhibit 1. 

The information collected will be 

used to test and improve the draft 

survey items in the Pharmacy Survey on 

Patient Safety Culture Questionnaire. 

Psychometric analysis will be 

conducted on the pilot data to examine 

item nonresponse, item response 

variability, factor structure, reliability, 

and construct validity of the items 

included in the survey. Because the 

survey items are being developed to 

measure specific aspects of patient 

safety culture in the pharmacy setting, 

the factor structure of the survey items 

will be evaluated through multilevel 

confirmatory factor analysis. On the 

basis of the data analyses, items or 

factors may be dropped. 

Estimated Annual Respondent Burden 

Exhibit 1 shows the estimated 

annualized burden hours for the 

pharmacies’ time to participate in this 

research. Cognitive interviews will be 

conducted with staff at 20 pharmacies 

(approximately 10 pharmacists and 10 

nonpharmacist staff) and will take about 

one hour and 30 minutes to complete. 

627 staff from 60 pharmacies will 

participate in the pretest (an average of 

10.45 staff from each pharmacy). The 

pretest questionnaire (the Pharmacy 

Survey on Patient Safety Culture) 


srobinson on DSKHWCL6B1PROD with NOTICES