[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Pages 1955-1957]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-00540]



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 

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 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 
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].


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 

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]