Proposed Collection; Comment Request, 71171-71172 [2012-28860]
Download as PDF
<![CDATA[
pmangrum on DSK3VPTVN1PROD with NOTICES
Federal Register / Vol. 77, No. 230 / Thursday, November 29, 2012 / Notices
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
VerDate Mar<15>2010
15:12 Nov 28, 2012
Jkt 229001
(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,
PO 00000
Frm 00005
Fmt 4703
Sfmt 4703
71171
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
Office of the Assistant
Secretary of Defense for Health Affairs,
DoD.
ACTION: Notice.
AGENCY:
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:
E:\FR\FM\29NON1.SGM
29NON1
71172
Federal Register / Vol. 77, No. 230 / Thursday, November 29, 2012 / Notices
• Federal eRulemaking Portal: https://
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 https://
www.regulations.gov as they are
received without change, including any
personal identifiers or contact
information.
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:
pmangrum on DSK3VPTVN1PROD with NOTICES
FOR FURTHER INFORMATION CONTACT:
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
VerDate Mar<15>2010
15:12 Nov 28, 2012
Jkt 229001
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
TRICARE Management
Activity, DoD.
ACTION: Notice.
AGENCY:
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:
PO 00000
Frm 00006
Fmt 4703
Sfmt 4703
• Federal eRulemaking Portal: https://
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 https://
www.regulations.gov as they are
received without change, including any
personal identifiers or contact
information.
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
FOR FURTHER INFORMATION CONTACT:
E:\FR\FM\29NON1.SGM
29NON1
]]>Agencies
[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71171-71172]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28860]
=======================================================================
-----------------------------------------------------------------------
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:
[[Page 71172]]
Federal eRulemaking Portal: https://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 https://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 MHS-deployed 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
