Ultra High Throughput Sequencing for Clinical Diagnostic Applications-Approaches To Assess Analytical Validity; Public Meeting; Request for Comments, 28990-28991 [2011-12310]
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28990
Federal Register / Vol. 76, No. 97 / Thursday, May 19, 2011 / Notices
Dated: May 11, 2011.
Steven Hanmer,
OPRE Reports, Clearance Officer.
[FR Doc. 2011–12150 Filed 5–18–11; 8:45 am]
BILLING CODE 4184–22–M
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2011–N–0301]
Ultra High Throughput Sequencing for
Clinical Diagnostic Applications—
Approaches To Assess Analytical
Validity; Public Meeting; Request for
Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
jlentini on DSK4TPTVN1PROD with NOTICES
ACTION:
The Food and Drug Administration
(FDA) is announcing the following
public meeting entitled ‘‘Ultra High
Throughput Sequencing for Clinical
Diagnostic Applications—Approaches
To Assess Analytical Validity.’’ The
purpose of the public meeting is to
discuss challenges in assessing
analytical performance for ultra high
throughput genomic sequencing-based
clinical applications.
Date and Time: The public meeting
will be held on June 23, 2011, from 8
a.m. to 6 p.m.
Location: The public meeting will be
held at the FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31,
rm. 1503 (the Great Room), Silver
Spring, MD 20993–0002. For parking
and security information, please visit
the following Web site: https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm. The public meeting
will also be available to be viewed
online via Web cast.
Contact Person: Zivana Tezak, Center
for Devices and Radiological Health,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 66, rm.
5668, Silver Spring, MD 20993–0002,
301–796–6206, e-mail:
zivana.tezak@fda.hhs.gov.
Registration and Requests for Oral
Presentations: If you wish to attend or
view the Web cast of the public meeting,
you must register online at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm (select the appropriate
meeting from the list).
Provide complete contact information
for each attendee, including name, title,
affiliation, e-mail, and telephone
VerDate Mar<15>2010
15:54 May 18, 2011
Jkt 223001
number. Registration requests should be
received by June 9, 2011.
If you wish to make an oral
presentation during the open comment
session at the meeting, you must
indicate this at the time of registration.
FDA has included general discussion
topics for comment in section III of this
document, Topics for Input. You should
also identify which discussion topic you
wish to address in your presentation.
FDA will do its best to accommodate
requests to speak. Individuals and
organizations with common interests are
urged to consolidate or coordinate their
presentations and to request time for a
joint presentation. FDA will determine
the amount of time allotted to each
presenter and the approximate time that
each oral presentation is scheduled to
begin.
Registration is free and will be on a
first-come, first-served basis. Early
registration is recommended because
seating is limited. FDA may limit the
number of participants from each
organization based on space limitations.
Registrants will receive confirmation
once they have been accepted. Onsite
registration on the day of the public
meeting will be provided on a spaceavailable basis beginning at 7 a.m. NonU.S. citizens are subject to additional
security screening, and they should
register as soon as possible.
If you need special accommodations
due to a disability, please contact Susan
Monahan, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 4321, Silver Spring,
MD 20993–0002, 301–796–5661, e-mail:
susan.monahan@fda.hhs.gov at least 7
days in advance of the meeting.
Streaming Web Cast of the Public
Meeting: There will be a registration
process for the Web cast, and it will be
on a first-come, first-served basis
(maximum capacity: 900). If you have
never attended a Connect Pro meeting
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, but FDA is not responsible
for any subsequent changes to the Web
sites after this document publishes in
the Federal Register.)
Comments: FDA is holding this public
meeting to discuss a number of
questions regarding appropriate
approaches to assess analytical validity
of ultra high throughput sequencing for
clinical diagnostic applications. The
deadline for submitting comments to be
PO 00000
Frm 00043
Fmt 4703
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presented at this public meeting is
June 9, 2011.
Regardless of attendance at the public
meeting, interested persons may submit
either electronic or written comments
on any discussion topic(s) to the open
docket. The deadline for submitting
comments to the docket is July 23, 2011.
Submit electronic comments to https://
www.regulations.gov. Submit written
comments to the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. It is only
necessary to send one set of comments.
It is no longer necessary to send two
copies of mailed comments. Identify
comments with the docket number
found in brackets in the heading of this
document. In addition, if responding to
specific topics as outlined in section III
of this document, please identify the
topic you are addressing. Received
comments may be seen in the Division
of Dockets Management between 9 a.m.
and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
Ultra high throughput genomic
sequencing technologies are currently
extensively used in research and are
entering clinical diagnostic use; they are
expected to bring transformative public
health applications. In order to
effectively utilize new sequencing
technologies for clinical applications,
appropriate evaluation tools (e.g.,
standards, well established criteria) are
needed to determine the accuracy of the
results. Any regulatory strategy for
clinical tests based on ultra high
throughput genomic sequencing will
benefit from novel and scientifically
agreed-upon approaches to analytical
validation. FDA is holding this public
meeting to start discussion on
approaches that can provide the most
useful information in establishing safety
and effectiveness of genomic sequencing
technologies when used clinically.
This public meeting seeks input from
academia, Government, industry, and
other stakeholders on validation
methodologies, materials, and
bioinformatics approaches needed to
address unique analytical validation
requirements of ultra high throughput
sequencing based molecular diagnostics
and confirm the sequencing quality and
the accuracy of the tests. The ultimate
goal is to accelerate and support the
introduction of safe and effective
innovative diagnostics in public health
applications.
II. Meeting Overview
The public meeting will consist of
presentations providing background on
E:\FR\FM\19MYN1.SGM
19MYN1
Federal Register / Vol. 76, No. 97 / Thursday, May 19, 2011 / Notices
current and anticipated uses for
sequencing technologies, an open public
comment session, and roundtable
discussions on selected topics. (See
section III of this document.) The
roundtable participants will not be
asked to develop consensus opinions
during the discussion, but rather to
provide their individual perspectives.
Others in attendance at the public
meeting will have an opportunity to
listen to the roundtable discussion.
Additional information, including a
meeting agenda, will be available on the
Internet., immediately after publication
of this Federal Register notice. This
information will be placed on file in the
public docket (docket number found in
brackets in the heading of this
document), which is available at https://
www.regulations.gov. This information
will also be available at https://
www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
default.htm (select the appropriate
meeting from the list).
III. Topics for Input
FDA seeks input on the following
issues:
1. Technical performance:
• Acceptance criteria,
• Validation samples/panels,
• Comparator/analytical standard.
2. Bioinformatics:
• Data format,
• Data analysis.
IV. Transcripts
jlentini on DSK4TPTVN1PROD with NOTICES
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
(HFA–305), Food and Drug
Administration, 5630 Fishers Lane, rm.
1061, Rockville, MD 20852. A transcript
will also be available in either hardcopy
or on CD–ROM, after submission of a
Freedom of Information request. Written
requests are to be sent to Division of
Freedom of Information, 12420
Parklawn Dr., rm. 1050, Rockville, MD
20857.
Dated: May 13, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–12310 Filed 5–18–11; 8:45 am]
BILLING CODE 4160–01–P
VerDate Mar<15>2010
15:54 May 18, 2011
Jkt 223001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Privacy Act of 1974; Report of a New
System of Records
Health Resources and Services
Administration, HHS.
AGENCY:
ACTION:
Notice of a new system of
records.
In accordance with the
requirements of the Privacy Act of 1974,
the Health Resources and Services
Administration (HRSA) is proposing a
new system of records. The
Countermeasures Injury Compensation
Program (CICP), authorized by the
Public Readiness and Emergency
Preparedness Act (PREP Act), provides
compensation to certain individuals for
serious physical injuries or deaths
resulting from the administration or use
of pandemic, epidemic, or security
countermeasures identified in
declarations issued by the Secretary of
the U.S. Department of Health and
Human Services (the Secretary)
pursuant to section 319F–3(b) of the
Public Health Service Act (PHS Act) (42
U.S.C. 247d–6d). The Secretary has
issued several declarations specifying
covered countermeasures, such as the
pandemic 2009 H1N1 influenza
vaccines, antiviral medications (e.g.,
Tamiflu), anthrax vaccines, and
smallpox vaccines. The PREP Act
directs the Secretary to establish
administrative procedures to
compensate individuals who sustained
serious injuries as the direct result of
the administration or use of covered
countermeasures. This system of records
is required to comply with the
implementation directives of the PREP
Act, Public Law 109–148. The records
will be used for the CICP’s resource
planning, administrative
implementation (e.g., making medical
and/or financial eligibility
determinations), compensating
requesters, evaluation, scientific
research, monitoring, and document
storage purposes.
SUMMARY:
HRSA invites interested parties
to submit comments on the proposed
New System of Records on or before
June 20, 2011. As of the date of the
publication of this Notice, HRSA has
sent a Report of New System of Records
to Congress and to the Office of
Management and Budget (OMB). The
New System of Records will be effective
40 days from the date submitted to OMB
unless HRSA receives comments that
DATES:
PO 00000
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Fmt 4703
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28991
would result in a contrary
determination.
ADDRESSES: Please address comments to
the Director, Countermeasures Injury
Compensation Program, Healthcare
Systems Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 11C–06, Rockville,
Maryland 20857; telephone 1–800–
ASK–HRSA (275–4772). This is a tollfree number. Comments received will be
available for inspection at this same
address from 9 a.m. to 3 p.m., Eastern
Standard Time, Monday through Friday.
FOR FURTHER INFORMATION CONTACT:
Director, Countermeasures Injury
Compensation Program, Healthcare
Systems Bureau, Health Resources and
Services Administration, 5600 Fishers
Lane, Room 11C–06, Rockville,
Maryland 20857; telephone toll-free 1–
800–ASK–HRSA (275–4772).
SUPPLEMENTARY INFORMATION: HRSA
proposes to establish a new system of
records: ‘‘The Countermeasures Injury
Compensation Program, HHS/HRSA/
HSB.’’ The PREP Act which is a part of
the ‘‘Department of Defense, Emergency
Supplemental Appropriations to
Address Hurricanes in the Gulf of
Mexico, and Pandemic Influenza Act,
2006’’ (Pub. L. 109–148), was enacted on
December 30, 2005, and confers broad
liability protections on covered persons,
as defined in section 319F–3(i)(2) of the
PHS Act, and authorizes the creation of
a Countermeasures Injury Compensation
Program (CICP or the Program) to
compensate individuals injured by the
administration or use of covered
countermeasures, as defined in section
319F–3(i)(1) of the PHS Act, in the event
of designated present or future public
health emergencies. The Secretary has
issued regulations for the administrative
implementation of the Program at 42
CFR part 110.
The PREP Act provides the Secretary
the authority, which was delegated by
the Secretary on November 8, 2006 to
the Administrator of HRSA, to
compensate eligible individuals for
covered injuries from a covered
countermeasure.
Compensation benefits will be
provided for eligible individuals who
suffer serious physical injuries or death
resulting from pandemic, epidemic, or
security countermeasures such as
vaccines identified in declarations
issued by the Secretary under a ‘‘PREP
Act declaration’’ issued in response to a
current public health emergency, or to
a credible risk that the disease,
condition, or threat may in the future
constitute such an emergency. The
Secretary has issued several pandemic
influenza declarations specifying
E:\FR\FM\19MYN1.SGM
19MYN1
]]>Agencies
[Federal Register Volume 76, Number 97 (Thursday, May 19, 2011)]
[Notices]
[Pages 28990-28991]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-12310]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2011-N-0301]
Ultra High Throughput Sequencing for Clinical Diagnostic
Applications--Approaches To Assess Analytical Validity; Public Meeting;
Request for Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
The Food and Drug Administration (FDA) is announcing the following
public meeting entitled ``Ultra High Throughput Sequencing for Clinical
Diagnostic Applications--Approaches To Assess Analytical Validity.''
The purpose of the public meeting is to discuss challenges in assessing
analytical performance for ultra high throughput genomic sequencing-
based clinical applications.
Date and Time: The public meeting will be held on June 23, 2011,
from 8 a.m. to 6 p.m.
Location: The public meeting will be held at the FDA White Oak
Campus, 10903 New Hampshire Ave., Bldg. 31, rm. 1503 (the Great Room),
Silver Spring, MD 20993-0002. For parking and security information,
please visit the following Web site: https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm. The public meeting will also be available to be viewed
online via Web cast.
Contact Person: Zivana Tezak, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, rm. 5668, Silver Spring, MD 20993-0002, 301-796-6206, e-mail:
zivana.tezak@fda.hhs.gov.
Registration and Requests for Oral Presentations: If you wish to
attend or view the Web cast of the public meeting, you must register
online at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the appropriate meeting from
the list).
Provide complete contact information for each attendee, including
name, title, affiliation, e-mail, and telephone number. Registration
requests should be received by June 9, 2011.
If you wish to make an oral presentation during the open comment
session at the meeting, you must indicate this at the time of
registration. FDA has included general discussion topics for comment in
section III of this document, Topics for Input. You should also
identify which discussion topic you wish to address in your
presentation. FDA will do its best to accommodate requests to speak.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations and to request time for a
joint presentation. FDA will determine the amount of time allotted to
each presenter and the approximate time that each oral presentation is
scheduled to begin.
Registration is free and will be on a first-come, first-served
basis. Early registration is recommended because seating is limited.
FDA may limit the number of participants from each organization based
on space limitations. Registrants will receive confirmation once they
have been accepted. Onsite registration on the day of the public
meeting will be provided on a space-available basis beginning at 7 a.m.
Non-U.S. citizens are subject to additional security screening, and
they should register as soon as possible.
If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 4321,
Silver Spring, MD 20993-0002, 301-796-5661, e-mail:
susan.monahan@fda.hhs.gov at least 7 days in advance of the meeting.
Streaming Web Cast of the Public Meeting: There will be a
registration process for the Web cast, and it will be on a first-come,
first-served basis (maximum capacity: 900). If you have never attended
a Connect Pro meeting 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, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
Comments: FDA is holding this public meeting to discuss a number of
questions regarding appropriate approaches to assess analytical
validity of ultra high throughput sequencing for clinical diagnostic
applications. The deadline for submitting comments to be presented at
this public meeting is June 9, 2011.
Regardless of attendance at the public meeting, interested persons
may submit either electronic or written comments on any discussion
topic(s) to the open docket. The deadline for submitting comments to
the docket is July 23, 2011. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852. It is only necessary to send one set of
comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. In addition, if responding to specific
topics as outlined in section III of this document, please identify the
topic you are addressing. Received comments may be seen in the Division
of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
SUPPLEMENTARY INFORMATION:
I. Background
Ultra high throughput genomic sequencing technologies are currently
extensively used in research and are entering clinical diagnostic use;
they are expected to bring transformative public health applications.
In order to effectively utilize new sequencing technologies for
clinical applications, appropriate evaluation tools (e.g., standards,
well established criteria) are needed to determine the accuracy of the
results. Any regulatory strategy for clinical tests based on ultra high
throughput genomic sequencing will benefit from novel and
scientifically agreed-upon approaches to analytical validation. FDA is
holding this public meeting to start discussion on approaches that can
provide the most useful information in establishing safety and
effectiveness of genomic sequencing technologies when used clinically.
This public meeting seeks input from academia, Government,
industry, and other stakeholders on validation methodologies,
materials, and bioinformatics approaches needed to address unique
analytical validation requirements of ultra high throughput sequencing
based molecular diagnostics and confirm the sequencing quality and the
accuracy of the tests. The ultimate goal is to accelerate and support
the introduction of safe and effective innovative diagnostics in public
health applications.
II. Meeting Overview
The public meeting will consist of presentations providing
background on
[[Page 28991]]
current and anticipated uses for sequencing technologies, an open
public comment session, and roundtable discussions on selected topics.
(See section III of this document.) The roundtable participants will
not be asked to develop consensus opinions during the discussion, but
rather to provide their individual perspectives. Others in attendance
at the public meeting will have an opportunity to listen to the
roundtable discussion.
Additional information, including a meeting agenda, will be
available on the Internet., immediately after publication of this
Federal Register notice. This information will be placed on file in the
public docket (docket number found in brackets in the heading of this
document), which is available at https://www.regulations.gov. This
information will also be available at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm (select the
appropriate meeting from the list).
III. Topics for Input
FDA seeks input on the following issues:
1. Technical performance:
Acceptance criteria,
Validation samples/panels,
Comparator/analytical standard.
2. Bioinformatics:
Data format,
Data analysis.
IV. 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 (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. Written requests
are to be sent to Division of Freedom of Information, 12420 Parklawn
Dr., rm. 1050, Rockville, MD 20857.
Dated: May 13, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-12310 Filed 5-18-11; 8:45 am]
BILLING CODE 4160-01-P
