Patient and Medical Professional Perspectives on the Return of Genetic Test Results and Interpretations; Public Workshop; Request for Comments, 1955-1957 [2016-00540]
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1955
Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
ANNUAL BURDEN ESTIMATES
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responses per
respondent
Average
burden hours
per response
Total burden
hours
Tribal PREP Plan .............................................................................................
10
1
40
400
Estimated Total Annual Burden
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In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
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comments may be forwarded by writing
to the Administration for Children and
Families, Office of Administration,
Office of Information Services, 370
L’Enfant Promenade SW., Washington,
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Officer. Email address: infocollection@
acf.hhs.gov. All requests should be
identified by the title of the information
collection.
The Department specifically requests
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respondents, including through the use
of automated collection techniques or
other forms of information technology.
Consideration will be given to
comments and suggestions submitted
within 60 days of this publication.
Robert Sargis,
Reports Clearance Officer.
[FR Doc. 2016–00595 Filed 1–13–16; 8:45 am]
BILLING CODE 4184–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2015–N–4809]
Patient and Medical Professional
Perspectives on the Return of Genetic
Test Results and Interpretations;
Public Workshop; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
18:58 Jan 13, 2016
Jkt 238001
Notice of public workshop;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing the
following public workshop entitled
‘‘Patient and Medical Professional
Perspectives on the Return of Genetic
Test Results.’’ The purpose of this
public workshop is to understand
patient and provider perspectives on
receiving potentially medically relevant
genetic test results. The topic(s) to be
discussed will focus on better defining
the specific information patients and
providers prefer to receive, with an
emphasis on the type(s) and amount of
evidence available to interpret the
results for medical purposes, how those
results should be returned, and what
information is needed to understand the
results in the event that they could
effectively aid in medical decision
making.
DATES: The public workshop will be
held on March 2, 2016, from 8 a.m. to
4 p.m. Submit either electronic or
written comments on the public
workshop by March 31, 2016.
ADDRESSES: The public workshop will
be held at FDA’s White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1, where routine
security check procedures will be
performed. For parking and security
information, please refer to https://www.
fda.gov/AboutFDA/WorkingatFDA/
BuildingsandFacilities/WhiteOak
CampusInformation/ucm241740.htm.
You may submit comments as
follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
PO 00000
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Sfmt 4703
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2015–N–4809 for ‘‘Patient and Medical
Professional Perspectives on the Return
of Genetic Test Results; Public
Workshop; Request for Comments.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
E:\FR\FM\14JAN1.SGM
14JAN1
1956
Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://www.
regulations.gov and insert the docket
number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Cara
Tenenbaum, Center for Devices and
Radiological Health, Food and Drug
Administration, Bldg. 66, Rm. 5563,
10903 New Hampshire Ave., Silver
Spring, MD 20993, 301–796–8456,
cara.tenenbaum@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
mstockstill on DSK4VPTVN1PROD with NOTICES
I. Background
In his State of the Union address on
January 20, 2015, President Obama
launched the Precision Medicine
Initiative (PMI),1 in order to empower
health care providers to tailor treatment
and prevention strategies to an
individual’s unique characteristics. This
may include analysis of genetic
information, including information
gathered through Next Generation
Sequencing (NGS). As part of PMI, FDA
is considering new approaches in its
regulation of NGS. FDA is interested in
promoting innovation while ensuring
that patients have access to cutting edge
technologies that are accurate and
provide meaningful information to
inform their health care decisions.
1 The Precision Medicine Initiative found on the
White House’s Web site at: https://www.whitehouse.
gov/precision-medicine.
VerDate Sep<11>2014
16:39 Jan 13, 2016
Jkt 238001
NGS produces significant amounts of
information, including some that may
be difficult for patients and health care
professionals to interpret with presently
available scientific knowledge. In some
cases, the evidence for association of
many genetic variants with particular
diseases is limited because of the rarity
of the variant or because it partially
contributes to a disease in combination
with other factors. In other cases, the
evidence may be contradictory or not be
available currently, but may be clearer
in the future. Additionally, some
findings may be unexpected or
incidental to what a physician is
looking for. FDA seeks to learn, when
results are generated in a CLIAcompliant laboratory, which results are
of importance to patients and providers,
how those results should be returned,
and how much and what types of
evidence supporting interpretation of
those results is necessary. Thus, FDA is
seeking public input from patients and
health care professionals to inform its
approach regarding the return of results
of genetic tests.
II. Topics for Discussion at the Public
Workshop
In response to President Obama’s
PMI, the public workshop will consider
the different uses of genetic testing. For
example, tests that determine the risk of
developing a condition, tests that
diagnose hereditary genetic disorders,
and tests that can guide treatment or
therapeutic interventions. Additionally,
the workshop and invited speakers will
cover various topics, including which
results (e.g., variants or mutations) and
interpretations are useful to patients
when undergoing genetic testing; what
types of results patients would want to
receive when there is no medical action
that can be taken; how best can results
of genetic test be presented; patients’
preference in receiving results that are
supported by limited or conflicting
evidence and how best such results
should be presented; how information
can be best presented to ease integration
into clinical care and health care
provider workflow; what providers want
to know about results that are supported
by limited or conflicting evidence; what
information should be included in test
reports and how it should be presented;
and what specific information providers
can do without.
FDA will present case studies as a
starting point for discussion, which will
be available on the meeting Web page in
advance of the public meeting.
Furthermore, the following will be
considered in the context of different
uses of genetic testing: Health literacy/
numeracy of patients; genetics/genomics
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Fmt 4703
Sfmt 4703
literacy of health care practitioners; the
personal utility of knowing about the
presence of a mutation or variant
whether it is actionable or not; that a
mutation or variant may have limited
evidence at the time the test is initially
run but evidence may be gathered that
changes the interpretation of the
mutation or variant; privacy concerns;
demographic information and
subpopulations; undiagnosed patients;
and underserved populations.
Registration: Registration is free and
available on a first-come, first-served
basis. Persons interested in attending
this public workshop must register
online by February 24, 2016, 4 p.m.
Early registration is recommended
because space is limited and, therefore,
FDA may limit the number of
participants from each organization. If
time and space permits, onsite
registration on the day of the public
workshop will be provided beginning at
8 a.m.
If you need special accommodations
due to a disability, please contact Susan
Monahan, email: susan.monahan@
fda.hhs.gov, phone: 301–796–5661, no
later than February 20, 2016.
To register for the public workshop,
please visit FDA’s Medical Devices
News & Events—Workshops &
Conferences calendar at https://www.fda.
gov/MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
(Select this meeting/public workshop
from the posted events list.) Please
provide complete contact information
for each attendee, including name, title,
affiliation, email, and telephone
number. Those without Internet access
should contact Susan Monahan to
register (see contact for special
accommodations). Registrants will
receive confirmation after they have
been accepted. You will be notified if
you are on a waiting list.
Streaming Webcast of the Public
Workshop: This public workshop will
also be Webcast. If you have never
attended a Connect Pro event before,
test your connection at https://
collaboration.fda.gov/common/help/en/
support/meeting_test.htm. To get a
quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. FDA has
verified the Web site addresses in this
document, as of the date this document
publishes in the Federal Register, but
Web sites are subject to change over
time.
Requests for Oral Presentations: This
public workshop includes public
comment and topic-focused sessions.
During online registration you may
indicate if you wish to present during a
public comment session. FDA has
E:\FR\FM\14JAN1.SGM
14JAN1
Federal Register / Vol. 81, No. 9 / Thursday, January 14, 2016 / Notices
included general topics for discussion
in this document. If you do request to
present public comments, please list
which topics you wish to address. FDA
will do its best to accommodate requests
to make public comment. Following the
close of registration, FDA will
determine the amount of time allotted to
each presenter and the approximate
time each oral presentation is to begin,
and will select and notify participants
by February 24, 2016. All requests to
make oral presentations must be
received by the close of registration on
February 24, 2016, at 4 p.m. If selected
for presentation, any presentation
materials must be emailed to Cara
Tenenbaum (see FURTHER INFORMATION
CONTACT) no later than February 26,
2016. No commercial promotional
material will be permitted to be
presented or distributed at the public
workshop.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at https://www.
regulations.gov. It may be viewed at the
Division of Dockets Management (see
ADDRESSES). A transcript will also be
available in either hardcopy or on CD–
ROM, after submission of a Freedom of
Information request. The Freedom of
Information office address is available
on the Agency’s Web site at https://
www.fda.gov. A link to the transcripts
will also be available approximately 45
days after the public workshop on the
Internet at https://www.fda.gov/Medical
Devices/NewsEvents/Workshops
Conferences/default.htm. (Select this
public workshop from the posted events
list.)
Dated: January 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–00540 Filed 1–13–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
mstockstill on DSK4VPTVN1PROD with NOTICES
[Docket No. FDA–2012–D–0307]
Revised Preventive Measures To
Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products;
Guidance for Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
VerDate Sep<11>2014
16:39 Jan 13, 2016
Jkt 238001
announcing the availability of a
document entitled ‘‘Revised Preventive
Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products;
Guidance for Industry.’’ The guidance
document provides blood collecting
establishments and manufacturers of
plasma derivatives with comprehensive
recommendations intended to minimize
the possible risk of transmission of
Creutzfeldt-Jakob Disease (CJD) and
Variant Creutzfeldt-Jakob Disease (vCJD)
from blood and blood products. The
guidance amends the guidance
document entitled ‘‘Guidance for
Industry: Revised Preventive Measures
to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease (CJD) and Variant CreutzfeldtJakob Disease (vCJD) by Blood and
Blood Products’’ dated May 2010 (2010
guidance) by finalizing and
incorporating the recommendations
from the draft document entitled ‘‘Draft
Guidance for Industry: Amendment to
’Guidance for Industry: Revised
Preventive Measures to Reduce the
Possible Risk of Transmission of
Creutzfeldt-Jakob Disease and Variant
Creutzfeldt-Jakob Disease by Blood and
Blood Products’’’ dated June 2012 (2012
draft guidance).
DATES: Submit either electronic or
written comments on Agency guidances
at any time.
ADDRESSES: You may submit comments
as follows:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
PO 00000
Frm 00021
Fmt 4703
Sfmt 4703
1957
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2012–D–0307 for Revised Preventive
Measures to Reduce the Possible Risk of
Transmission of Creutzfeldt-Jakob
Disease and Variant Creutzfeldt-Jakob
Disease by Blood and Blood Products;
Guidance for Industry. Received
comments will be placed in the docket
and, except for those submitted as
‘‘Confidential Submissions,’’ publicly
viewable at https://www.regulations.gov
or at the Division of Dockets
Management between 9 a.m. and 4 p.m.,
Monday through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION’’. The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
E:\FR\FM\14JAN1.SGM
14JAN1
]]>Agencies
[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Pages 1955-1957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00540]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2015-N-4809]
Patient and Medical Professional Perspectives on the Return of
Genetic Test Results and Interpretations; Public Workshop; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public workshop; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Patient and Medical Professional
Perspectives on the Return of Genetic Test Results.'' The purpose of
this public workshop is to understand patient and provider perspectives
on receiving potentially medically relevant genetic test results. The
topic(s) to be discussed will focus on better defining the specific
information patients and providers prefer to receive, with an emphasis
on the type(s) and amount of evidence available to interpret the
results for medical purposes, how those results should be returned, and
what information is needed to understand the results in the event that
they could effectively aid in medical decision making.
DATES: The public workshop will be held on March 2, 2016, from 8 a.m.
to 4 p.m. Submit either electronic or written comments on the public
workshop by March 31, 2016.
ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting
participants (non-FDA employees) is through Building 1, where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2015-N-4809 for ``Patient and Medical Professional Perspectives on
the Return of Genetic Test Results; Public Workshop; Request for
Comments.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including
[[Page 1956]]
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Division of
Dockets Management. If you do not wish your name and contact
information to be made publicly available, you can provide this
information on the cover sheet and not in the body of your comments and
you must identify this information as ``confidential.'' Any information
marked as ``confidential'' will not be disclosed except in accordance
with 21 CFR 10.20 and other applicable disclosure law. For more
information about FDA's posting of comments to public dockets, see 80
FR 56469, September 18, 2015, or access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Cara Tenenbaum, Center for Devices and
Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 5563,
10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-8456,
cara.tenenbaum@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In his State of the Union address on January 20, 2015, President
Obama launched the Precision Medicine Initiative (PMI),\1\ in order to
empower health care providers to tailor treatment and prevention
strategies to an individual's unique characteristics. This may include
analysis of genetic information, including information gathered through
Next Generation Sequencing (NGS). As part of PMI, FDA is considering
new approaches in its regulation of NGS. FDA is interested in promoting
innovation while ensuring that patients have access to cutting edge
technologies that are accurate and provide meaningful information to
inform their health care decisions.
---------------------------------------------------------------------------
\1\ The Precision Medicine Initiative found on the White House's
Web site at: https://www.whitehouse.gov/precision-medicine.
---------------------------------------------------------------------------
NGS produces significant amounts of information, including some
that may be difficult for patients and health care professionals to
interpret with presently available scientific knowledge. In some cases,
the evidence for association of many genetic variants with particular
diseases is limited because of the rarity of the variant or because it
partially contributes to a disease in combination with other factors.
In other cases, the evidence may be contradictory or not be available
currently, but may be clearer in the future. Additionally, some
findings may be unexpected or incidental to what a physician is looking
for. FDA seeks to learn, when results are generated in a CLIA-compliant
laboratory, which results are of importance to patients and providers,
how those results should be returned, and how much and what types of
evidence supporting interpretation of those results is necessary. Thus,
FDA is seeking public input from patients and health care professionals
to inform its approach regarding the return of results of genetic
tests.
II. Topics for Discussion at the Public Workshop
In response to President Obama's PMI, the public workshop will
consider the different uses of genetic testing. For example, tests that
determine the risk of developing a condition, tests that diagnose
hereditary genetic disorders, and tests that can guide treatment or
therapeutic interventions. Additionally, the workshop and invited
speakers will cover various topics, including which results (e.g.,
variants or mutations) and interpretations are useful to patients when
undergoing genetic testing; what types of results patients would want
to receive when there is no medical action that can be taken; how best
can results of genetic test be presented; patients' preference in
receiving results that are supported by limited or conflicting evidence
and how best such results should be presented; how information can be
best presented to ease integration into clinical care and health care
provider workflow; what providers want to know about results that are
supported by limited or conflicting evidence; what information should
be included in test reports and how it should be presented; and what
specific information providers can do without.
FDA will present case studies as a starting point for discussion,
which will be available on the meeting Web page in advance of the
public meeting. Furthermore, the following will be considered in the
context of different uses of genetic testing: Health literacy/numeracy
of patients; genetics/genomics literacy of health care practitioners;
the personal utility of knowing about the presence of a mutation or
variant whether it is actionable or not; that a mutation or variant may
have limited evidence at the time the test is initially run but
evidence may be gathered that changes the interpretation of the
mutation or variant; privacy concerns; demographic information and
subpopulations; undiagnosed patients; and underserved populations.
Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by February 24, 2016, 4 p.m. Early
registration is recommended because space is limited and, therefore,
FDA may limit the number of participants from each organization. If
time and space permits, onsite registration on the day of the public
workshop will be provided beginning at 8 a.m.
If you need special accommodations due to a disability, please
contact Susan Monahan, email: susan.monahan@fda.hhs.gov, phone: 301-
796-5661, no later than February 20, 2016.
To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this meeting/public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, email, and telephone number. Those
without Internet access should contact Susan Monahan to register (see
contact for special accommodations). Registrants will receive
confirmation after they have been accepted. You will be notified if you
are on a waiting list.
Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. If you have never attended a Connect Pro event before,
test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro
program, visit https://www.adobe.com/go/connectpro_overview. FDA has
verified the Web site addresses in this document, as of the date this
document publishes in the Federal Register, but Web sites are subject
to change over time.
Requests for Oral Presentations: This public workshop includes
public comment and topic-focused sessions. During online registration
you may indicate if you wish to present during a public comment
session. FDA has
[[Page 1957]]
included general topics for discussion in this document. If you do
request to present public comments, please list which topics you wish
to address. FDA will do its best to accommodate requests to make public
comment. Following the close of registration, FDA will determine the
amount of time allotted to each presenter and the approximate time each
oral presentation is to begin, and will select and notify participants
by February 24, 2016. All requests to make oral presentations must be
received by the close of registration on February 24, 2016, at 4 p.m.
If selected for presentation, any presentation materials must be
emailed to Cara Tenenbaum (see FURTHER INFORMATION CONTACT) no later
than February 26, 2016. No commercial promotional material will be
permitted to be presented or distributed at the public workshop.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at https://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
https://www.fda.gov. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
Dated: January 7, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00540 Filed 1-13-16; 8:45 am]
BILLING CODE 4164-01-P
