Federal Register / Vol. 77, No. 238 / Tuesday, December 11, 2012 / Notices 73669 

approximately 6 weeks after the initial 

call to the center. This follow-up 

telephone interview (MI/SP Caller 

Follow-up Interview) will be conducted 

to collect information on demographic 

characteristics, gather caller feedback on 

the initial call made to the center, 

suicide risk status at the time of and 

since the call, current depressive 

symptomatology, follow through with 

the safety plan and referrals made by the 

crisis counselor, and barriers to service. 

Prior to collecting information during 

the MI/SP Caller Follow-up Interview, 

researchers will read callers the MI/SP 

Caller Follow-up Consent Script. Taking 

into account attrition and the number of 

callers who do not give consent, it is 

expected that the total number of 

follow-up interviews conducted by the 

research team will not exceed 1,107. 

The estimated response burden to 

collect this information is as follows 

annualized over the requested 3-year 

clearance period is presented below: 

ANNUALIZED AVERAGES: RESPONDENTS, RESPONSES AND HOURS

Instrument No. of 

respondents 

No. of 

responses per 

Respondent * 

Total number 

of responses 

Burden/ 

response 

(hours) 

Annual 

burden * 

(hours) 

MI/SP Caller Initial Script ..................................................... 500 1 500 .08 40 

MI/SP Caller Follow-up Consent Script ............................... 369 1 369 .17 63 

MI/SP Caller Follow-up Interview ........................................ 369 1 369 .67 247 

MI/SP Counselor Consent ................................................... 250 1 250 .08 20 

MI/SP Counselor Attitudes Questionnaire ........................... 250 1 250 .25 63 

MI/SP Counselor Follow-up Questionnaire ......................... 250 5 1250 .17 213 

Total .............................................................................. 1,988 ........................ ........................ ........................ 646 

* Rounded to the nearest whole number. 

Send comments to Summer King, 

SAMHSA Reports Clearance Officer, 

Room 2–1057, One Choke Cherry Road, 

Rockville, MD 20857 AND email her a 

copy at summer.king@samhsa.hhs.gov. 

Written comments should be received 

within 60 days of this notice. 

Summer King, 

Statistician. 

[FR Doc. 2012–29825 Filed 12–10–12; 8:45 am] 

BILLING CODE 4162–20–P 

DEPARTMENT OF HOMELAND 

SECURITY 

Office of the Secretary 

[Docket No. DHS–2012–0041] 

Response to Comments Received for 

the ‘‘The Menlo Report: Ethical 

Principles Guiding Information and 

Communication Technology 

Research’’ (‘‘The Menlo Report’’) for 

the Department of Homeland Security 

(DHS), Science and Technology, Cyber 

Security Division (CSD), Protected 

Repository for the Defense of 

Infrastructure Against Cyber Threats 

(PREDICT) Project 

AGENCY: Science and Technology 

Directorate, DHS. 

ACTION: Response. 

SUMMARY: The Department of Homeland 

Security (DHS), Science and Technology 

(S&T) published a 60-day public notice 

in the Federal Register on December 28, 

2011 (Federal Register Volume 76, 

Number 249, Docket No. DHS–2011– 

0074) to invite public comment on the 

Menlo Report. The intent of the notice 

was to further refine the content of the 

Menlo Report beyond the working group 

that had generated the report. This 

notice responds to the comments 

received during this 60-day public 

notice. 

ADDRESSES: The updated Menlo Report 

may be found at http:// 

www.cyber.st.dhs.gov/. 

FOR FURTHER INFORMATION CONTACT: DHS 

S&T, Email Menlo_Report@dhs.gov. 

SUPPLEMENTARY INFORMATION: 

Background 

A grassroots working group composed 

of stakeholders in information and 

communication technology research 

(ICTR), with support from the 

Homeland Security Advanced Research 

Projects Agency (HSARPA) CSD, 

developed the Menlo Report. HSARPA 

CSD published this report in the 

Federal Register in December 2011 (76 

FR 81517, Docket No. DHS–2011–0074) 

to invite public comment, and sixteen 

comments were received. The complete 

text of the public comments and the 

Federal Register notice are available on 

the Regulations.gov web site at http:// 

www.regulations.gov/ 

#!docketDetail;D=DHS-2011-0074. 

To address the comments, a subset of 

the initial working group was assembled 

that has stewarded the document since 

its inception. In summary, the 

comments contained both laudatory and 

critical remarks and covered issues that 

ranged in scope from targeted to general. 

The approach to absorbing this valuable 

feedback was to analyze each comment, 

distill the issue(s) raised by the 

commenter, reflect on the relevant text 

in the Menlo Report, and generate a 

response. Those responses entailed 

identifying proposed changes intended 

to resolve the issues raised, either by 

modifying text that was unclear or 

misinterpreted by readers or by 

accepting constructive criticism. 

Changes to the Report 

The Menlo Report has been updated 

and is available at http:// 

www.cyber.st.dhs.gov/. Overall, the 

changes to the Menlo Report based on 

the comments are summarized as 

follows: 

1. The next version will clarify that 

the Menlo Report is not an official 

policy statement of DHS and that DHS 

does not have the intention or authority 

to permit researchers to engage in any 

practice in the name of ‘‘ethical 

research.’’ 

2. The next version will reflect that 

the main focus of the Menlo Report is 

on private sector and academic 

researchers who may be government 

funded, rather than DHS employees. 

While the Menlo Report may certainly 

be applicable to government 

researchers, it is not intended to conflict 

with or preempt statutory or regulatory 

requirements placed on government 

employees. 

3. The next version will explicitly 

address the choice of Belmont Report 

model instead of an alternative ethical 

framework (i.e., a Belmont Report 

principles-in-context approach). 

Specifically, the next version of the 

Menlo Report will clarify the benefit to 

society versus the risks to research 

subjects under this model. 


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73670 Federal Register / Vol. 77, No. 238 / Tuesday, December 11, 2012 / Notices 

4. The next version will address the 

relationship between law and ethics, 

(i.e., when a researcher’s ethicallyderived beliefs are in direct conflict 

with relevant laws) by stating it is 

beyond the scope of the Menlo Report 

to advocate a position when laws 

directly conflict with ethics. Rather, the 

Menlo Report reinforces the principle 

that ethics plays a role in closing gaps 

in laws and clarifying grayness in 

interpretation of laws. 

5. The next version will highlight the 

value of the Menlo Report guidelines to 

society rather than just researchers. 

Detailed Comments and Responses 

S&T published a 60-day public notice 

in the Federal Register on December 28, 

2011 (Federal Register Volume 76, 

Number 249, Docket No. DHS–2011– 

0074) to invite public comment on the 

Menlo Report. The notice helped further 

refine the content of the Menlo Report 

by seeking comments on the document 

generated by the working group. At the 

end of the 60-day comment period, S&T 

received sixteen comments from two 

universities, four private citizens, three 

non-profit organizations, one foreign 

university, and one professional 

association. In general, the comments 

received fall into the following 

categories: 

1. The Menlo Report construed as 

official DHS policy 

2. Interpretation of informed consent 

3. Researcher interaction with a 

research subject’s computer 

4. Calculating benefits and harms 

5. Estimation of benefits and harms 

from ICTR 

6. Applicability of the Institutional 

Review Board (IRB) model for ethical 

review of ICTR 

7. The relationship between laws and 

ethics 

8. Privacy rights of individuals related 

to corporate monitoring 

9. Ethical considerations for future 

contemplation and study 

10. Standalone comments 

A. The Menlo Report As Official DHS 

policy 

Several comments stated that the 

Menlo Report is an official policy 

statement of DHS and that DHS has the 

intention or authority to permit 

researchers to engage in any practice in 

the name of ‘‘ethical research.’’ 

Response: The Menlo Report offers 

ethical guidance for public and private 

researchers and explicitly advocates 

respect for the law and public interest 

(e.g., supporting the notion that 

different laws may apply to government 

researchers) and is neither an official 

nor authoritative policy statement for 

DHS or law enforcement. As a result, 

modifications to the Menlo Report will 

have additional, explicit language to 

indicate that while DHS supports the 

Menlo Report, the Menlo Report does 

not represent official agency policy nor 

should it be interpreted as applying to, 

conflicting with, or superseding 

statutory mandates and other 

authoritative commitments governing 

actions by the government. 

B. Interpretation of Informed Consent 

Several comments were received 

related to the discussion of informed 

consent in the Menlo Report. 

Response: Support for informed 

consent will be conveyed by the Menlo 

Report byh detailing how researchers 

and Research Ethics Boards (REB) 

should consider the situation where 

waivers of informed consent are sought. 

Modifications to the Menlo Report will 

substitute the term ‘‘proxy’’ with the 

Common Rule term ‘‘legally authorized 

representative,’’ clarify the issue of their 

relationship to requests for waivers, and 

better balance the perspective between 

that of researchers and that of end-users 

or research subjects. The respondents 

agree with the observation in various 

comments regarding ICTR and waivers 

to informed consent and will highlight 

this issue in modifications to the Menlo 

Report. Given the gravity and ubiquity 

of cyber-crime, the benefits and 

importance of accurate research data for 

countering it is a specific situation that 

may satisfy the requirements of 45 CFR 

46.116 allowing requests for alteration 

or elimination of informed consent 

requirements in those situations where 

minimal risk to subjects (or those reliant 

on information and communication 

technology (ICT) under study) exists. 

C. Researcher Interaction With a 

Research Subject’s Computer 

Multiple comments dealt with the 

issue of interacting with a research 

subject’s computer or interacting with 

malicious software under study that the 

owner of the computer is not even 

aware exists on their computer. 

Response: It is understood that the 

study of malicious software, to include 

botnets, is an area that can pose greater 

than minimal risk to those who rely on 

infected computers. Ultimately, the 

issue of what constitutes ‘‘minimal 

risk,’’ and also whether it is ‘‘human 

subjects research’’ to interact with the 

computer, as opposed to the human, 

must be determined. Given that IRB in 

the United States today do not require 

that researchers adhere to zero-risk, but 

rather they are guided by requirements 

of 45 CFR 46.111, the Menlo Report will 

be updated to clarify the justification for 

this approach by illuminating the 

consequences of a zero-risk tolerance 

approach, noting, for example, how it 

would negatively impact the public’s 

ability to benefit from research. 

D. Calculating Benefits and Harms 

Various comments received also 

raised issues regarding the estimation of 

benefits and harms from ICTR, 

including not only who may be harmed 

but also how potential benefits and 

harms can be quantified. 

Response: The current ‘‘Identifying 

Harms’’ section of the Menlo Report 

addresses concerns about lack of 

comprehensive coverage of harms. 

However, to bolster this area, the Menlo 

Report will be updated to address the 

potential, rather than certainty, of harms 

resulting from research activities. 

Specifically, personal privacy and 

information confidentiality and integrity 

are uncontrovertibly noted as potential 

harms that must be addressed. Updates 

will also clarify the distinction and 

relevance of the benefit to society versus 

the risks to research subjects in ICTR. 

The respondents will also change the 

text to include harms resulting from 

notification of research, and publication 

of information that can be used to cause 

harm. Additional verbiage will also seek 

to clarify the distinction and relevance 

of the benefit to society versus the risks 

to research subjects in ICTR. 

E. Applicability of the Institutional 

Review Board (IRB) Model 

Several comments raised the 

appropriateness of the Belmont/IRB 

model, related to both behavioral and 

biomedical research, for ethical review 

of ICTR. 

Response: The purpose of the Menlo 

Report is to advocate principles and 

applications, not to define enforcement 

mechanisms. The crux of these 

comments related to applicability of the 

Belmont Report. The next version of the 

Menlo Report will concretely state that 

it is deliberately founded on the 

Belmont model, which was originally 

developed for the biomedical research 

context but is not limited to 

biomedicine, as evidenced by the fact 

that this model is currently used for 

evaluation of behavioral research 

(including that which involves ICT). 

F. Relationship Between Laws and 

Ethics 

Many comments were received 

relating to conflicts between ethical 

codes and the law. 

Response: The comments were 

diverse but converged on the necessity 

to add text regarding the relationship 

between law and ethics. The assertion 


tkelley on DSK3SPTVN1PROD with 
Federal Register / Vol. 77, No. 238 / Tuesday, December 11, 2012 / Notices 73671 

that the Menlo Report precludes the 

Common Rule is conjecture that 

appeared in one of the comments, and 

it is important to mention that this is 

not substantiated by evidence from the 

Menlo Report. This criticism does not 

reflect what is presently allowed by the 

Common Rule in terms of waivers (see 

45 CFR 46.116, specifically subsections 

(c) and (d)). The Menlo Report currently 

is framed in such a way as to be 

congruous with the predominant REB 

model in the United States, IRB. The 

Menlo Report will be revised to include 

text that clarifies that the Menlo Report 

does not take any stance on addressing 

the situation when laws are viewed by 

the public to be unethical. It was also 

apparent from the comments that the 

Menlo Report needs to clarify that 

researchers are not authorized to waive 

consent. The Menlo Report will also be 

updated in the Respect for Law and 

Public Interest section to address 

conflicts with principles of compliance, 

transparency, and accountability and 

with the privacy interests of 

individuals. 

G. Privacy of Individuals vs. 

Corporations 

Multiple comments highlighted a 

problem regarding the discussion on the 

privacy of an organization in relation 

with enhancing cyber security. 

Response: This discussion will be 

removed from the next version of the 

Menlo Report. The comments correctly 

indentified a potential inconsistency. 

H. Ethical Considerations for Future 

Contemplation and Atudy 

Finally, there were comments 

suggesting a general call for further 

study and engagement with various 

communities and agencies in order to 

create workable guidance. 

Response: Much additional work will 

be done as a follow on to the Menlo 

Report to spur additional discussion of 

the approach to ethics in ICTR 

presented in the Menlo Report. Some of 

this research has already been 

undertaken and is included in a 

companion report to the Menlo Report. 

I. Standalone Comments 

There were several comments that did 

not fall into the preceding categories but 

did spur further changes to the Menlo 

Report. The following will be reflected 

as updates to the Menlo Report: 

1. A clarification will be added 

explaining that while the Menlo Report 

adopts Belmont Report principles and 

the Common Rule regime in framing the 

principles and applications for 

evaluating and applying ethics in ICTR, 

it also highlights areas within the 

Common Rule that are more frequently 

exercised by ICTR or that may cause 

problems in applying it to ICTR. 

2. Language to more clearly discuss 

how to make inclusion/exclusion 

decisions in conformance with Justice 

and Equity considerations will be 

added. 

3. In general, the revised Menlo 

Report will take a well-rounded 

perspective to include the end-user 

perspective, in addition to a researchercentric perspective. 

4. The discussion of the existence and 

management of pre-existing data will be 

expanded. 

5. The discussion regarding the 

creation of the Internet and its growth 

to include the hosting databases with 

personally identifiable information will 

be clarified. 

6. The description or context of the 

use of the term ‘‘reasonable researcher’’ 

will be updated. 

7. Explanatory language to address the 

issue of record retention will be 

included in the Mitigation of Realized 

Harms section. 

8. The term ‘‘evidence-based 

consideration’’ will be clarified. 

Dated: November 30, 2012. 

Tara O’Toole, 

Under Secretary for Science and Technology. 

[FR Doc. 2012–29818 Filed 12–10–12; 8:45 am] 

BILLING CODE 9110–9F–P 

DEPARTMENT OF HOMELAND 

SECURITY 

U.S. Customs and Border Protection 

Agency Information Collection 

Activities: Deferral of Duty on Large 

Yachts Imported for Sale 

AGENCY: U.S. Customs and Border 

Protection, Department of Homeland 

Security. 

ACTION: 30-Day notice and request for 

comments; extension of an existing 

collection of information: 1651–0080. 

SUMMARY: U.S. Customs and Border 

Protection (CBP) of the Department of 

Homeland Security will be submitting 

the following information collection 

request to the Office of Management and 

Budget (OMB) for review and approval 

in accordance with the Paperwork 

Reduction Act: Deferral of Duty on 

Large Yachts Imported for Sale. This is 

a proposed extension of an information 

collection that was previously 

approved. CBP is proposing that this 

information collection be extended with 

no change to the burden hours or to the 

information collected. This document is 

published to obtain comments from the 

public and affected agencies. This 

proposed information collection was 

previously published in the Federal 

Register (77 FR 60133) on October 2, 

2012, allowing for a 60-day comment 

period. This notice allows for an 

additional 30 days for public comments. 

This process is conducted in accordance 

with 5 CFR 1320.10. 

DATES: Written comments should be 

received on or before January 10, 2013. 

ADDRESSES: Interested persons are 

invited to submit written comments on 

this proposed information collection to 

the Office of Information and Regulatory 

Affairs, Office of Management and 

Budget. Comments should be addressed 

to the OMB Desk Officer for Customs 

and Border Protection, Department of 

Homeland Security, and sent via 

electronic mail to 

oira_submission@omb.eop.gov or faxed 

to (202) 395–5806. 

FOR FURTHER INFORMATION CONTACT: 

Requests for additional information 

should be directed to Tracey Denning, 

U.S. Customs and Border Protection, 

Regulations and Rulings, Office of 

International Trade, 799 9th Street NW., 

5th Floor, Washington, DC 20229–1177, 

at 202–325–0265. 

SUPPLEMENTARY INFORMATION: CBP 

invites the general public and other 

Federal agencies to comment on 

proposed and/or continuing information 

collections pursuant to the Paperwork 

Reduction Act of 1995 (Pub. L. 104–13; 

44 U.S.C. 3505(c)(2)). The comments 

should address: (a) Whether the 

collection of information is necessary 

for the proper performance of the 

functions of the agency, including 

whether the information shall have 

practical utility; (b) the accuracy of the 

agency’s estimates of the burden of the 

collection of information; (c) ways to 

enhance the quality, utility, and clarity 

of the information to be collected; (d) 

ways to minimize the burden including 

the use of automated collection 

techniques or the use of other forms of 

information technology; and (e) the 

annual cost burden to respondents or 

record keepers from the collection of 

information (a total capital/startup costs 

and operations and maintenance costs). 

The comments that are submitted will 

be summarized and included in the CBP 

request for Office of Management and 

Budget (OMB) approval. All comments 

will become a matter of public record. 

In this document CBP is soliciting 

comments concerning the following 

information collection: 

Title: Deferral of Duty on Large Yachts 

Imported for Sale. 

OMB Number: 1651–0080. 

Form Number: None. 


tkelley on DSK3SPTVN1PROD with