[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]
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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.
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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 http://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: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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 http://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
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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 http://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: http://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 http://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,
[email protected].
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.
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\1\ The Precision Medicine Initiative found on the White House's
Web site at: https://www.whitehouse.gov/precision-medicine.
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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: [email protected], 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 http://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 http://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
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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 http://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
http://www.fda.gov. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://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]
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