81 FR 1426 - Next Generation Sequencing-Based Oncology Panels; Public Workshop; Request for Comments
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 7 (January 12, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 7 (January 12, 2016)
| Page Range | 1426-1428 | |
| FR Document | 2016-00328 |
[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)] [Notices] [Pages 1426-1428] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-00328] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2015-N-4990] Next Generation Sequencing-Based Oncology Panels; 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 a public workshop entitled ``Next Generation Sequencing-Based Oncology Panels.'' The purpose of this workshop is to obtain feedback on analytical and clinical validation approaches for next generation sequencing (NGS)- based oncology panels. Comments and suggestions generated through this workshop will help guide the development of appropriate regulatory standards for evaluation of NGS-based oncology panels in cancer patient management. DATES: The public workshop will be held on February 25, 2016, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on the public workshop by March 28, 2016. ADDRESSES: The public workshop will be held at FDA's White Oak Campus, 10903 New Hampshire Ave., Bldg. 31, Rm. 1503 B and C (the Great Room), Silver Spring, MD 20993. Entrance for the public workshop 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-4990 for ``Next Generation Sequencing-Based Oncology Panels.'' 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 the claimed confidential information, in [[Page 1427]] 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: Jennifer Dickey, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 5648, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-5028, Jennifer.Dickey@fda.hhs.gov. I. Background A number of oncology therapeutic products have been approved with corresponding companion diagnostics (Ref. 1). To date, approved companion diagnostic assays assess a single analyte or prespecified mutations associated with therapeutic response; however, NGS technology can interrogate a patient's tumor specimen for numerous biomarkers concurrently, introducing challenges to the current companion diagnostic paradigm. Additionally, NGS tumor panels are increasingly employed for use in similar oncology applications because the technology can be used to screen a cancer patient's specimen for many relevant mutations simultaneously. FDA is holding this public workshop to solicit input from external stakeholders on approaches to establish performance characteristics of NGS-based oncology panels that include variants that are intended to be used as companion diagnostics, as well as other variants that may be used for alternative therapeutic management of patients who have already been considered for all appropriate therapies. The Agency is requesting public input on strategies for establishing performance characteristics for NGS-based oncology panels for rare variants across tumor types, follow-on companion diagnostic claims, and post-approval assay modifications. Further details to be considered and discussed at the workshop will be outlined in a discussion paper that will be posted publicly and available prior to the workshop at the following site: http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) II. Topics for Discussion at the Public Workshop This public workshop will consist of brief presentations to provide information to frame the goals of the workshop and interactive discussions via several panel sessions. Following the presentations, there will be a moderated discussion where speakers and additional panelists will be asked to provide their individual perspectives. The presentations and discussions will focus on several topics, including a description of a hypothetical NGS-based oncology panel test and its general intended use; considerations for pre-analytical and quality metric approaches; challenges in analytical validation and the potential for development of a flexible approach for post-approval assay modifications; and the framework for clinical and follow-on companion diagnostic claims. In advance of the meeting, FDA plans to post a discussion paper outlining FDA's current thinking for NGS-based oncology panels and the issues for discussion at the workshop at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.) FDA will place the discussion paper on file in the public docket (docket number found in brackets in the heading of this document) and will post it at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The deadline for submitting comments on this document for presentation at the public workshop is February 2, 2016, although comments related to this document can be submitted until March 28, 2016. A detailed agenda will be posted on this Web site in advance of the workshop. Registration: Registration is free and available on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 4 p.m. on February 17, 2016. Early registration is recommended because facilities are 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 7:30 a.m. If you need special accommodations due to a disability, please contact Susan Monahan, Center for Devices and Radiological Health, Office of Communication and Education, phone 301-796-5661, email: mailto:Susan.Monahan@fda.hhs.gov no later than 4 p.m. on February 11, 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 special accommodations contact). 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. The Webcast link will be available on the registration Web page after February 17, 2016. 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.) 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, but FDA is not responsible for any subsequent changes to the Web sites after this document publishes in the Federal Register.) Requests for Oral Presentations: This public workshop includes a public comment session. During online registration you may indicate if you wish to present during a public comment session, and which topics you wish to address. FDA has included general topics in this document which will be addressed in greater detail in a [[Page 1428]] subsequent discussion paper (see SUPPLEMENTARY INFORMATION). FDA will do its best to accommodate requests to make public comment. Individuals and organizations with common interests are urged to consolidate or coordinate their presentations, and request time for a joint presentation, or submit requests for designated representatives to participate in the focused sessions. All requests to make oral presentations must be received by February 2, 2016. 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 8, 2016. If selected for presentation, any presentation materials must be emailed to Jennifer Dickey (see FOR FURTHER INFORMATION CONTACT) no later than February 16, 2016, at 4 p.m. No commercial promotional material will be permitted to be presented or distributed at this 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.) III. Reference The following reference is on display in the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address, as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. 1. Please refer to FDA's Web site on companion diagnostics, available at http://www.fda.gov/companiondiagnostics. Dated: January 5, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016-00328 Filed 1-11-16; 8:45 am] BILLING CODE 4164-01-P
![1426 Federal Register / Vol. 81, No. 7 / Tuesday, January 12, 2016 / Notices
variability of employer costs in the case integrated OSH-wellness approaches. burden estimates include the time for
studies. NIOSH expects to complete data reviewing instructions, searching
If the WWGP is effective at improving collection in 2017. It is estimated that a existing data sources, gathering and
worker health, reducing WC claims and maximum of 100 individuals will be maintaining the data needed, and
demonstrating a positive economic interviewed (up to 50 for the semi- participating in the interview. There are
return, then other employers and structured economic interviews and up no costs to interviewees other than their
insurance carriers may develop similar to 100 for the annual case study time. The total estimated annual burden
programs and drive the optimization of verification interviews). The hour- hours are 150.
ESTIMATED ANNUALIZED BURDEN HOURS
Average
Number of
Type of Number of burden per
Form name responses per
respondents respondents response
respondent (in hrs.)
Wellness Program Coordina- Employers interview on cost of wellness and occupational 25 1 2
tors. safety and health program.
Occupational Safety and Employers interview on cost of wellness and occupational 25 1 2
Health Specialists. safety and health program.
The person in charge of the Annual case study verification interview ................................ 100 1 30/60
employer’s wellness pro-
gram.
Leroy A. Richardson, ADDRESSES: The public workshop will written/paper submission and in the
Chief, Information Collection Review Office, be held at FDA’s White Oak Campus, manner detailed (see ‘‘Written/Paper
Office of Scientific Integrity, Office of the 10903 New Hampshire Ave., Bldg. 31, Submissions’’ and ‘‘Instructions’’).
Associate Director for Science, Office of the Rm. 1503 B and C (the Great Room),
Director, Centers for Disease Control and Written/Paper Submissions
Silver Spring, MD 20993. Entrance for
Prevention. the public workshop participants (non- Submit written/paper submissions as
[FR Doc. 2016–00383 Filed 1–11–16; 8:45 am] FDA employees) is through Building 1 follows:
BILLING CODE 4163–18–P where routine security check • Mail/Hand delivery/Courier (for
procedures will be performed. For written/paper submissions): Division of
parking and security information, please Dockets Management (HFA–305), Food
DEPARTMENT OF HEALTH AND refer to http://www.fda.gov/AboutFDA/ and Drug Administration, 5630 Fishers
HUMAN SERVICES WorkingatFDA/BuildingsandFacilities/ Lane, Rm. 1061, Rockville, MD 20852.
WhiteOakCampusInformation/ • For written/paper comments
Food and Drug Administration submitted to the Division of Dockets
ucm241740.htm.
[Docket No. FDA–2015–N–4990] You may submit comments as Management, FDA will post your
follows: comment, as well as any attachments,
Next Generation Sequencing-Based except for information submitted,
Oncology Panels; Public Workshop; Electronic Submissions marked and identified, as confidential,
Request for Comments Submit electronic comments in the if submitted as detailed in
following way: ‘‘Instructions.’’
AGENCY: Food and Drug Administration, • Federal eRulemaking Portal: http:// Instructions: All submissions received
HHS. www.regulations.gov. Follow the must include the Docket No. FDA–
ACTION: Notice of public workshop; instructions for submitting comments. 2015–N–4990 for ‘‘Next Generation
request for comments. Comments submitted electronically, Sequencing-Based Oncology Panels.’’
including attachments, to http:// Received comments will be placed in
SUMMARY: The Food and Drug www.regulations.gov will be posted to the docket and, except for those
Administration (FDA) is announcing a the docket unchanged. Because your submitted as ‘‘Confidential
public workshop entitled ‘‘Next comment will be made public, you are Submissions,’’ publicly viewable at
Generation Sequencing-Based Oncology solely responsible for ensuring that your http://www.regulations.gov or at the
Panels.’’ The purpose of this workshop comment does not include any Division of Dockets Management
is to obtain feedback on analytical and confidential information that you or a between 9 a.m. and 4 p.m., Monday
clinical validation approaches for next third party may not wish to be posted, through Friday.
generation sequencing (NGS)-based such as medical information, your or • Confidential Submissions—To
oncology panels. Comments and anyone else’s Social Security number, or submit a comment with confidential
suggestions generated through this confidential business information, such information that you do not wish to be
workshop will help guide the as a manufacturing process. Please note made publicly available, submit your
development of appropriate regulatory that if you include your name, contact comments only as a written/paper
standards for evaluation of NGS-based information, or other information that submission. You should submit two
oncology panels in cancer patient
tkelley on DSK3SPTVN1PROD with NOTICES
identifies you in the body of your copies total. One copy will include the
management. comments, that information will be information you claim to be confidential
DATES: The public workshop will be posted on http://www.regulations.gov. with a heading or cover note that states
held on February 25, 2016, from 8:30 • If you want to submit a comment ‘‘THIS DOCUMENT CONTAINS
a.m. to 5 p.m. Submit either electronic with confidential information that you CONFIDENTIAL INFORMATION.’’ The
or written comments on the public do not wish to be made available to the Agency will review this copy, including
workshop by March 28, 2016. public, submit the comment as a the claimed confidential information, in
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![1428 Federal Register / Vol. 81, No. 7 / Tuesday, January 12, 2016 / Notices
subsequent discussion paper (see DEPARTMENT OF HEALTH AND public submit the comment as a written/
SUPPLEMENTARY INFORMATION). FDA will HUMAN SERVICES paper submission and in the manner
do its best to accommodate requests to detailed (see ‘‘Written/Paper
make public comment. Individuals and Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
organizations with common interests are [Docket No. FDA–2012–N–0977] Written/Paper Submissions
urged to consolidate or coordinate their
presentations, and request time for a Agency Information Collection Submit written/paper submissions as
joint presentation, or submit requests for Activities; Proposed Collection; follows:
• Mail/Hand delivery/Courier (for
designated representatives to participate Comment Request; Regulations
written/paper submissions): Division of
in the focused sessions. All requests to Restricting the Sale and Distribution of
Dockets Management (HFA–305), Food
make oral presentations must be Cigarettes and Smokeless Tobacco To
and Drug Administration, 5630 Fishers
received by February 2, 2016. FDA will Protect Children and Adolescents
Lane, Rm. 1061, Rockville, MD 20852.
determine the amount of time allotted to AGENCY: Food and Drug Administration, • For written/paper comments
each presenter and the approximate HHS. submitted to the Division of Dockets
time each oral presentation is to begin, Management, FDA will post your
ACTION: Notice.
and will select and notify participants comment, as well as any attachments,
by February 8, 2016. If selected for SUMMARY: The Food and Drug except for information submitted,
presentation, any presentation materials Administration (FDA) is announcing an marked, and identified, as confidential,
must be emailed to Jennifer Dickey (see opportunity for public comment on the if submitted as detailed in
FOR FURTHER INFORMATION CONTACT) no proposed collection of certain ‘‘Instructions.’’
later than February 16, 2016, at 4 p.m. information by the Agency. Under the Instructions: All submissions received
No commercial promotional material Paperwork Reduction Act of 1995 (the must include the Docket No. FDA–
will be permitted to be presented or PRA), Federal Agencies are required to 2012–N–0977 for ‘‘Agency Information
distributed at this public workshop. publish notice in the Federal Register Collection Activities; Proposed
concerning each proposed collection of Collection; Comment Request;
Transcripts: Please be advised that as Regulations Restricting the Sale and
soon as a transcript is available, it will information, including each proposed
extension of an existing collection of Distribution of Cigarettes and Smokeless
be accessible at http:// Tobacco to Protect Children and
www.regulations.gov. It may be viewed information, and to allow 60 days for
public comment in response to the Adolescents.’’ Received comments will
at the Division of Dockets Management be placed in the docket and, except for
(see ADDRESSES). A transcript will also notice. This notice solicits comments on
regulations restricting the sale and those submitted as ‘‘Confidential
be available in either hardcopy or on Submissions,’’ publicly viewable at
CD–ROM, after submission of a distribution of cigarettes and smokeless
tobacco to protect children and http://www.regulations.gov or at the
Freedom of Information request. The Division of Dockets Management
Freedom of Information Office address adolescents.
between 9 a.m. and 4 p.m., Monday
is available on the Agency’s Web site at DATES: Submit either electronic or through Friday.
http://www.fda.gov. A link to the written comments on the collection of • Confidential Submissions—To
transcripts will also be available information by March 14, 2016. submit a comment with confidential
approximately 45 days after the public ADDRESSES: You may submit comments information that you do not wish to be
workshop on the Internet at http:// as follows: made publicly available submit your
www.fda.gov/MedicalDevices/ comments only as a written/paper
Electronic Submissions submission. You should submit two
NewsEvents/WorkshopsConferences/
default.htm. (Select this public Submit electronic comments in the copies total. One copy will include the
workshop from the posted events list.) following way: information you claim to be confidential
• Federal eRulemaking Portal: http:// with a heading or cover note that states
III. Reference www.regulations.gov. Follow the ‘‘THIS DOCUMENT CONTAINS
The following reference is on display instructions for submitting comments. CONFIDENTIAL INFORMATION’’. The
in the Division of Dockets Management Comments submitted electronically, Agency will review this copy, including
(see ADDRESSES) and is available for including attachments, to http:// the claimed confidential information, in
www.regulations.gov will be posted to its consideration of comments. The
viewing by interested persons between
the docket unchanged. Because your second copy, which will have the
9 a.m. and 4 p.m., Monday through
comment will be made public, you are claimed confidential information
Friday; it is also available electronically
solely responsible for ensuring that your redacted/blacked out, will be available
at http://www.regulations.gov. FDA has
comment does not include any for public viewing and posted on http://
verified the Web site address, as of the
confidential information that you or a www.regulations.gov. Submit both
date this document publishes in the third party may not wish to be posted, copies to the Division of Dockets
Federal Register, but Web sites are such as medical information, your or Management. If you do not wish your
subject to change over time. anyone else’s Social Security number, or name and contact information to be
1. Please refer to FDA’s Web site on confidential business information, such made publicly available, you can
companion diagnostics, available at as a manufacturing process. Please note provide this information on the cover
http://www.fda.gov/ that if you include your name, contact sheet and not in the body of your
tkelley on DSK3SPTVN1PROD with NOTICES
companiondiagnostics. information, or other information that comments and you must identify this
Dated: January 5, 2016. identifies you in the body of your information as ‘‘confidential’’. Any
comments, that information will be information marked as ‘‘confidential’’
Leslie Kux,
posted on http://www.regulations.gov. will not be disclosed except in
Associate Commissioner for Policy. • If you want to submit a comment accordance with 21 CFR 10.20 and other
[FR Doc. 2016–00328 Filed 1–11–16; 8:45 am] with confidential information that you applicable disclosure law. For more
BILLING CODE 4164–01–P do not wish to be made available to the information about FDA’s posting of
VerDate Sep<11>2014 20:14 Jan 11, 2016 Jkt 238001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4703 E:\FR\FM\12JAN1.SGM 12JAN1](https://thefederalregister.org/doc/81_FR_1433/page/3.svg)
Document Created: 2016-01-12 01:22:53
Document Modified: 2016-01-12 01:22:53
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of public workshop; request for comments. | |
| Dates | The public workshop will be held on February 25, 2016, from 8:30 a.m. to 5 p.m. Submit either electronic or written comments on the public workshop by March 28, 2016. | |
| Contact | Jennifer Dickey, Center for Devices and Radiological Health, Food and Drug Administration, Bldg. 66, Rm. 5648, 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-5028, [email protected] | |
| FR Citation | 81 FR 1426 |
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