Federal Register / Vol. 77, No. 230 / Thursday, November 29, 2012 / Notices 71171 

activity has on the practice of medicine, 

including but not limited to the 

interpretation of testing results and 

performance of testing procedures; and 

(4) The role that cost and insurance 

coverage have on access to and 

provision of genetic diagnostic tests. 

In the Act, Congress defined the term 

‘‘confirming genetic diagnostic test 

activity’’ to mean the performance of a 

genetic diagnostic test, by a genetic 

diagnostic test provider, on an 

individual solely for the purpose of 

providing the individual with an 

independent confirmation of results 

obtained from another test provider’s 

prior performance of the test on the 

individual. 

Recognizing the diversity and 

complexity of the public policy issues 

surrounding independent second 

opinion genetic diagnostic testing, the 

USPTO conducted a thorough review of 

the academic and scientific literature, 

took notice of several published reports, 

and actively sought diverse and 

sophisticated input from the public. In 

that last regard, the Office published a 

notice in the Federal Register and on 

the USPTO public Web site dedicated to 

AIA implementation (AIA micro-site), 

seeking written comments and 

announcing two public hearings for this 

study. See Request for Comments and 

Notice of Public Hearings on Genetic 

Diagnostic Testing, 77 FR 3748 (Jan. 25, 

2012). The Office also provided the 

public with a dedicated email address 

and a contact person in the USPTO to 

receive comments. 

As announced in the Federal Register 

and on the AIA micro-site, the Office 

held two public hearings dedicated to 

taking public comment for this report. 

The first occurred at the USPTO 

headquarters in Alexandria, Virginia, on 

Thursday, February 16, 2012, and the 

second took place at the University of 

San Diego School of Law in San Diego, 

California, on Friday, March 9, 2012. At 

the hearings, witnesses provided prescheduled testimony, and members of 

the audience provided spontaneous 

testimony. Representatives from the 

USPTO attended the hearings and 

actively questioned all witnesses. Also, 

witnesses exchanged comments with 

the audience. 

In the final days before the deadline 

for receipt of written comments, the 

Supreme Court of the United States 

issued two rulings with potential 

ramifications for the present study. The 

first was a memorandum opinion in 

Mayo Collaborative Services v. 

Prometheus Laboratories, Inc., 132 S. Ct. 

1289 (2012). The second was an order 

in Association for Molecular Pathology 

v. Myriad Genetics, 132 S. Ct. 1794 

(2012), granting the petition for a writ of 

certiorari, vacating the decision of the 

United States Court of Appeals for the 

Federal Circuit (CAFC), and remanding 

the case for reconsideration in light of 

the Mayo decision. Accordingly, the 

USPTO published a notice on the AIA 

micro-site seeking additional public 

input, within ten calendar days, 

regarding the impact of the Supreme 

Court’s actions on independent second 

opinion genetic diagnostic testing. 

Through the Federal Register notice 

and hearings, the Office received 

twenty-seven sets of written comments 

and testimony from eighteen witnesses. 

Respondents with written comments, 

many of whom also testified, included 

four U.S. intellectual property 

organizations, thirteen U.S. companies 

and organizations, three U.S. patent 

practitioners, and seven members of the 

public speaking as individuals. 

On August 28, 2012, the Department 

of Commerce sent a letter to the House 

and Senate Judiciary Committee 

leadership updating them on the status 

of the genetic testing report. The letter 

stated in part: ‘‘Given the complexity 

and diversity of the opinions, 

comments, and suggestions provided by 

interested parties, and the important 

policy considerations involved, we 

believe that further review, discussion, 

and analysis are required before a final 

report can be submitted to Congress.’’ 

After this additional public roundtable, 

the USPTO will follow next steps and 

fulfill its obligation to Congress. 

Issues for Comment: The USPTO 

seeks comments on how to address the 

issue of independent second opinion 

genetic diagnostic testing and its 

relationship to medical care and 

medical practice, the rights of 

innovators, and considerations relevant 

to medical costs and insurance 

coverage. The issues enumerated below 

are as posed in the AIA and serve as a 

preliminary guide to aid the USPTO in 

collecting further relevant information 

and to evaluate possible administrative 

or legislative recommendations that may 

be provided to Congress. The tenor of 

the following issues should not be taken 

as an indication that the USPTO has 

taken a position or is predisposed to any 

particular views. The public is invited 

to address any or all of these issues. The 

public also is invited to provide input 

on other issues believed to be relevant 

to the scope of the study in addition to 

those listed below. 

(1) The impact that the current lack of 

independent second opinion testing has 

had on the ability to provide the highest 

level of medical care to patients and 

recipients of genetic diagnostic testing, 

and on inhibiting innovation to existing 

testing and diagnoses; 

(2) The effect that providing 

independent second opinion genetic 

diagnostic testing would have on the 

existing patent and license holders of an 

exclusive genetic test; 

(3) The impact that current exclusive 

licensing and patents on genetic testing 

activity has on the practice of medicine, 

including but not limited to the 

interpretation of testing results and 

performance of testing procedures; and 

(4) The role that cost and insurance 

coverage have on access to and 

provision of genetic diagnostic tests. 

Dated: November 21, 2012. 

David J. Kappos, 

Under Secretary of Commerce for Intellectual 

Property and Director of the United States 

Patent and Trademark Office. 

[FR Doc. 2012–28890 Filed 11–28–12; 8:45 am] 

BILLING CODE 3510–16–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[Docket ID DoD–2012–HA–0142] 

Proposed Collection; Comment 

Request 

AGENCY: Office of the Assistant 

Secretary of Defense for Health Affairs, 

DoD. 

ACTION: Notice. 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the Office of the 

Assistant Secretary of Defense for 

Health Affairs announces the proposed 

extension of a public information 

collection and seeks public comment on 

the provisions thereof. Comments are 

invited on: (a) Whether the proposed 

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 estimate of the burden of the 

proposed information collection; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the information collection on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

DATES: Consideration will be given to all 

comments received by January 28, 2013. 

ADDRESSES: You may submit comments, 

identified by docket number and title, 

by any of the following methods: 


pmangrum on DSK3VPTVN1PROD with NOTICES
71172 Federal Register / Vol. 77, No. 230 / Thursday, November 29, 2012 / Notices 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 4800 Mark Center Drive, 

East Tower, 2nd Floor, Suite 02G09, 

Alexandria, VA 22350–3100. 

Instructions: All submissions received 

must include the agency name, docket 

number and title for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet at http:// 

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on this 

proposed information collection or to 

obtain a copy of the proposal and 

associated collection instruments, 

please write to TRICARE Management 

Activity (TMA), Portfolio Management 

Division, ATTN: Karen Saddoris, 

CDFM–A, Project Officer, 5202 Leesburg 

Pike, Suite 1100, Falls Church, VA 

22041, or call TMA, at (703) 681–8448. 

Title; Associated Form; and OMB 

Number: Military Health Systems 

DHSS/DHIMS Information Systems User 

Satisfaction Survey, 0720–TBD. 

Needs and Uses: The information 

collection requirement is necessary to 

enable the Military Health Systems 

(MHS) Chief Information Officer (CIO) 

to employ a standardized approach to 

gather and report data across 20 to 25 

MHS-deployed systems/applications, 

for both Defense Military Health 

Systems (DHSS) and Defense Health 

Information Management Systems 

(DHIMS) in a repeatable process for 

continued monitoring of user 

satisfaction using established 

quantifiable outcome-based 

performance measures. Parallel efforts 

include the need to meet the National 

Defense Authorization Act (NDAA) 

requirement imposed by Congress in bill 

H.R. 6523. 

Affected Public: Business or other for 

profit; Not-for-profit institutions. 

Annual Burden Hours: 350. 

Number of Respondents: 3,000. 

Responses per Respondent: 1. 

Average Burden per Response: 7 

minutes. 

Frequency: Annually. 

SUPPLEMENTARY INFORMATION: 

Summary of Information Collection 

Respondents are staff contracted to 

the Department of Defense who use any 

of the approximately 20–25 MHSdeployed systems/applications. These 

systems/applications are used by the 

Army, Navy, and Air Force at their 

respective Command Headquarters, 

Surgeon’s General Office, Bureau of 

Medicine, Military Treatment Facilities, 

and at TMA Headquarters. The survey 

will determine user satisfaction with 

overall ease of use, access to 

information needed to perform their job, 

level of training, system response time 

when entering or accessing the 

information, and system availability/ 

minimal downtime. In addition to the 

quantitative measures, the survey will 

gather qualitative data to help identify 

customer ‘‘pain points’’ concerning each 

system. Final analysis will provide 

insight to the MHS organization on how 

best to improve the quality of care 

through existing health care systems. 

Dated: November 26, 2012. 

Aaron Siegel, 

Alternate OSD Federal Register Liaison 

Officer, Department of Defense. 

[FR Doc. 2012–28860 Filed 11–28–12; 8:45 am] 

BILLING CODE 5001–06–P 

DEPARTMENT OF DEFENSE 

Office of the Secretary 

[Docket ID DoD–2012–HA–0144] 

Proposed Collection; Comment 

Request 

AGENCY: TRICARE Management 

Activity, DoD. 

ACTION: Notice. 

In compliance with Section 

3506(c)(2)(A) of the Paperwork 

Reduction Act of 1995, the TRICARE 

Management Activity announces a 

proposed public information collection 

and seeks public comment on the 

provisions thereof. Comments are 

invited on: (a) Whether the proposed 

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 estimate of the burden of the 

proposed information collection; (c) 

ways to enhance the quality, utility, and 

clarity of the information to be 

collected; and (d) ways to minimize the 

burden of the information collection on 

respondents, including through the use 

of automated collection techniques or 

other forms of information technology. 

DATES: Consideration will be given to all 

comments received by January 28, 2013. 

ADDRESSES: You may submit comments, 

identified by docket number and title, 

by any of the following methods: 

• Federal eRulemaking Portal: http:// 

www.regulations.gov. Follow the 

instructions for submitting comments. 

• Mail: Federal Docket Management 

System Office, 4800 Mark Center Drive, 

East Tower, Suite 02G09, Alexandria, 

VA 22350–3100. 

Instructions: All submissions received 

must include the agency name, docket 

number and title for this Federal 

Register document. The general policy 

for comments and other submissions 

from members of the public is to make 

these submissions available for public 

viewing on the Internet at http:// 

www.regulations.gov as they are 

received without change, including any 

personal identifiers or contact 

information. 

FOR FURTHER INFORMATION CONTACT: To 

request more information on this 

proposed information collection or to 

obtain a copy of the proposal and 

associated collection instruments, 

please write to the TRICARE 

Management Activity (TMA), 

Beneficiary Education & Support, 

ATTN: Lennya Bonivento, 7700 

Arlington Boulevard, Suite 5101, Falls 

Church, VA 22042–5101, or call TMA 

Beneficiary Education & Support, at 

703–681–1770. 

Title; Associated Form; and OMB 

Number: Assistance Reporting Tool 

(ART), OMB Control Number: 0720– 

TBD. 

Needs and Uses: The ART is a secure 

web-based system that captures 

feedback on and authorization related to 

TRICARE benefits. Users are comprised 

of Military Health System (MHS) 

customer service personnel, to include 

Beneficiary Counseling and Assistance 

Coordinators, Debt Collection 

Assistance Officers, personnel, family 

support, recruiting command, case 

managers, and others who serve in a 

customer service support role. The ART 

is also the primary means by which 

Military Medical Support Office 

(MMSO) staff capture medical 

authorization determinations and claims 

assistance information for remotely 

located service members, line of duty 

care, and for care under the Transitional 

Care for Service-related Conditions 

benefit. ART data reflects the customer 

service mission within the MHS: it 

helps customer service staff users 

prioritize and manage their case 

workload; it allows users to track 

beneficiary inquiry workload and 

resolution, of which a major component 

is educating beneficiaries on their 

TRICARE benefits. Personal health 

information (PHI) and personally 

identifiable information (PII) entered 

into the system is received from 


pmangrum on DSK3VPTVN1PROD with NOTICES