Notice of Public Roundtable on Genetic Diagnostic Testing, 71170-71171 [2012-28890]
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71170
Federal Register / Vol. 77, No. 230 / Thursday, November 29, 2012 / Notices
Smart Grid standards, priorities, and
gaps, on the overall direction, status,
and health of the Smart Grid
implementation by the Smart Grid
industry, and on Smart Grid
Interoperability Panel activities,
including the direction of research and
standards activities. Background
information on the Committee is
available at https://www.nist.gov/
smartgrid/committee.cfm.
Pursuant to the Federal Advisory
Committee Act, as amended, 5 U.S.C.
App., notice is hereby given that the
Smart Grid Advisory Committee (SGAC
or Committee) will meet in open session
on Tuesday, December 18, 2012 from
8:30 a.m. to 5:00 p.m. Eastern time and
Wednesday, December 19, 2012 from
8:30 a.m. to 12:00 p.m. Eastern time.
The meeting will be open to the public
and held in Lecture Room A, in the
Administration Building at NIST in
Gaithersburg, Maryland. The primary
purposes of this meeting are to discuss
NIST’s response to recommendations
from the Committee’s report and to
receive presentations on cybersecurity
coordination and the NIST Smart Grid
Program Plan. The agenda may change
to accommodate Committee business.
The final agenda will be posted on the
Smart Grid Web site at https://
www.nist.gov/smartgrid.
Individuals and representatives of
organizations who would like to offer
comments and suggestions related to the
Committee’s affairs are invited to
request a place on the agenda by
submitting their request to Cuong
Nguyen at cuong.nguyen@nist.gov or
(301) 975–2254 no later than 5:00 p.m.
Eastern time, Tuesday, December 11,
2012. On Tuesday, December 18, 2012,
approximately one-half hour will be
reserved at the end of the meeting for
public comments, and speaking times
will be assigned on a first-come, firstserve basis. The amount of time per
speaker will be determined by the
number of requests received, but is
likely to be about 3 minutes each.
Questions from the public will not be
considered during this period. Speakers
who wish to expand upon their oral
statements, those who had wished to
speak but could not be accommodated
on the agenda, and those who were
unable to attend in person are invited to
submit written statements to the Office
of the National Coordinator for Smart
Grid Interoperability, National Institute
of Standards and Technology, 100
Bureau Drive, Mail Stop 8200,
Gaithersburg, MD 20899–8200; fax 301–
975–4091; or via email at
nistsgfac@nist.gov.
All visitors to the NIST site are
required to pre-register to be admitted.
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Anyone wishing to attend this meeting
must register by 5:00 p.m. Eastern time,
Tuesday, December 11, 2012, in order to
attend. Please submit your full name,
time of arrival, email address, and
phone number to Cuong Nguyen. NonU.S. citizens must also submit their
country of citizenship, title, employer/
sponsor, and address. Mr. Nguyen’s
email address is cuong.nguyen@nist.gov
and his phone number is (301) 975–
2254.
Dated: November 20, 2012.
Willie E. May,
Associate Director for Laboratory Programs.
[FR Doc. 2012–28876 Filed 11–28–12; 8:45 am]
BILLING CODE 3510–13–P
DEPARTMENT OF COMMERCE
United States Patent and Trademark
Office
[Docket No. PTO–C–2012–0049]
Notice of Public Roundtable on
Genetic Diagnostic Testing
United States Patent and
Trademark Office, Commerce.
ACTION: Notice of public roundtable.
AGENCY:
The United States Patent and
Trademark Office (‘‘USPTO’’) is
interested in gathering additional
information on independent second
opinion genetic diagnostic testing for
purposes of preparing a report on the
subject as required by the America
Invents Act (‘‘AIA’’ or ‘‘Act’’). To assist
in gathering this information, the
USPTO invites the public to attend a
roundtable focused on genetic
diagnostic testing.
Public Roundtable: The USPTO will
hold a public roundtable in support of
the genetic testing study. The
roundtable will be held on Thursday,
January 10, 2013, beginning at 1:00 p.m.
Eastern Standard Time (EST) and
ending at 4:00 p.m. (EST) in Alexandria,
Virginia.
Those wishing to share commentary
at the roundtable must request an
opportunity to do so in writing no later
than December 20, 2012. The request
must include the following: (1) The
name of the person wishing to share
commentary; (2) the person’s contact
information (telephone number and
email address); (3) the organization(s)
the person represents, if any; and (4) an
indication of the amount of time
requested for the commentary. Requests
to share commentary must be submitted
by email to Saurabh Vishnubhakat at
saurabh.vishnubhakat@uspto.gov.
Based upon the requests received, an
SUMMARY:
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Sfmt 4703
agenda will be sent to all requesters and
posted on the USPTO Internet Web site
(address: www.uspto.gov/
americainventsact).
Speakers sharing commentary at the
roundtable must submit a document
explaining their position for inclusion
in the record of the proceedings no later
than thirty days after the roundtable.
Written commentary should not exceed
25 pages using at least 12-point and
double-spaced font. Because written
commentary will be made available for
public inspection, information that a
speaker does not desire to be made
public, such as a telephone number,
should not be included in the written
comments.
The public roundtable will be
available via Web cast. Information
about how to access the Web cast will
be posted on the USPTO’s Internet Web
site (address: https://www.uspto.gov/
americainventsact) before the public
roundtable.
A transcript of the roundtable will be
available on the USPTO Internet Web
site (address: www.uspto.gov/
americainventsact) shortly after the
roundtable.
ADDRESSES: The public roundtable will
be held at the USPTO in the Madison
Auditorium on the concourse level of
the Madison Building, located at 600
Dulany Street, Alexandria, Virginia
22314.
FOR FURTHER INFORMATION CONTACT:
Saurabh Vishnubhakat, Expert Advisor,
Office of Chief Economist, by telephone
at 571–272–9300, or by email at
saurabh.vishnubhakat@uspto.gov.
SUPPLEMENTARY INFORMATION: Section 27
of the AIA charges the Director of the
USPTO with delivering to Congress a
study and recommendations no later
than nine months after the enactment of
the Act (i.e., by June 15, 2012) regarding
independent second opinion genetic
diagnostic testing where patents and
exclusive licenses exist that cover
primary genetic diagnostic tests.
Congress has mandated that the study
include an examination of at least the
following:
(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
E:\FR\FM\29NON1.SGM
29NON1
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
]]>Agencies
[Federal Register Volume 77, Number 230 (Thursday, November 29, 2012)]
[Notices]
[Pages 71170-71171]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-28890]
-----------------------------------------------------------------------
DEPARTMENT OF COMMERCE
United States Patent and Trademark Office
[Docket No. PTO-C-2012-0049]
Notice of Public Roundtable on Genetic Diagnostic Testing
AGENCY: United States Patent and Trademark Office, Commerce.
ACTION: Notice of public roundtable.
-----------------------------------------------------------------------
SUMMARY: The United States Patent and Trademark Office (``USPTO'') is
interested in gathering additional information on independent second
opinion genetic diagnostic testing for purposes of preparing a report
on the subject as required by the America Invents Act (``AIA'' or
``Act''). To assist in gathering this information, the USPTO invites
the public to attend a roundtable focused on genetic diagnostic
testing.
Public Roundtable: The USPTO will hold a public roundtable in
support of the genetic testing study. The roundtable will be held on
Thursday, January 10, 2013, beginning at 1:00 p.m. Eastern Standard
Time (EST) and ending at 4:00 p.m. (EST) in Alexandria, Virginia.
Those wishing to share commentary at the roundtable must request an
opportunity to do so in writing no later than December 20, 2012. The
request must include the following: (1) The name of the person wishing
to share commentary; (2) the person's contact information (telephone
number and email address); (3) the organization(s) the person
represents, if any; and (4) an indication of the amount of time
requested for the commentary. Requests to share commentary must be
submitted by email to Saurabh Vishnubhakat at
saurabh.vishnubhakat@uspto.gov. Based upon the requests received, an
agenda will be sent to all requesters and posted on the USPTO Internet
Web site (address: www.uspto.gov/americainventsact).
Speakers sharing commentary at the roundtable must submit a
document explaining their position for inclusion in the record of the
proceedings no later than thirty days after the roundtable. Written
commentary should not exceed 25 pages using at least 12-point and
double-spaced font. Because written commentary will be made available
for public inspection, information that a speaker does not desire to be
made public, such as a telephone number, should not be included in the
written comments.
The public roundtable will be available via Web cast. Information
about how to access the Web cast will be posted on the USPTO's Internet
Web site (address: https://www.uspto.gov/americainventsact) before the
public roundtable.
A transcript of the roundtable will be available on the USPTO
Internet Web site (address: www.uspto.gov/americainventsact) shortly
after the roundtable.
ADDRESSES: The public roundtable will be held at the USPTO in the
Madison Auditorium on the concourse level of the Madison Building,
located at 600 Dulany Street, Alexandria, Virginia 22314.
FOR FURTHER INFORMATION CONTACT: Saurabh Vishnubhakat, Expert Advisor,
Office of Chief Economist, by telephone at 571-272-9300, or by email at
saurabh.vishnubhakat@uspto.gov.
SUPPLEMENTARY INFORMATION: Section 27 of the AIA charges the Director
of the USPTO with delivering to Congress a study and recommendations no
later than nine months after the enactment of the Act (i.e., by June
15, 2012) regarding independent second opinion genetic diagnostic
testing where patents and exclusive licenses exist that cover primary
genetic diagnostic tests. Congress has mandated that the study include
an examination of at least the following:
(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
[[Page 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 pre-scheduled 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
