Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers, 13062-13063 [2014-04940]

Download as PDF 13062 Federal Register / Vol. 79, No. 45 / Friday, March 7, 2014 / Notices 3. Allows any one community, or region, to receive a disproportionate share of the funds available for award. 4. Is essentially identical or similar in whole, or in part, to previously funded projects proposed by the same applicant, or activities or projects proposed by a consortium that duplicates activities for which any consortium member also receives funding from ANA. 5. Provides couples or family counseling activities that are medically based. 6. Originated with and/or was designed by consultants who provide a major role for themselves and are not members of the applicant organization, tribe, or village. 7. Contains contingent activities that may impede, or indefinitely delay, the progress of the project. 8. Has the potential to cause unintended harm or that could negatively impact the safety or privacy of individuals. 9. May be used for the purpose of providing loan capital. Federal funds Excellent ................................... 93–100 awarded under this FOA may not be Very Good ................................ 86–92 used for the purpose of providing loan Good ......................................... 78–85 capital. This is not related to loan Fair ............................................ 70–77 Needs Significant Improvement 0–69 capital authorized under Sec. 803A of NAPA [42 U.S.C. 2991b–1(a)(1)] for the purpose of the Hawaiian Revolving K. ANA Internal Review of Proposed Loan fund. Projects: ANA proposes to clarify the language in Section V.2. Review and 10. Includes human subject research Selection Process of all FY 2014 FOAs as defined at 45 CFR 45.102(d) and (f). to clarify the scope of discretion to be L. Reporting: ANA would change the exercised in making funding decisions reporting requirement from quarterly to as follows: semi-annual for Objective Progress Based on the ranked order of applications, ANA staff will perform an Reports (OPR) and Financial Status Reports (FSR). Therefore, grantees will internal review and analysis of the be required to submit an OPR and an highest ranked applications in order to FSR every 6 months instead of every 3 determine their consistency with the purposes of NAPA, all relevant statutory months. Please note grantees will still be required to submit a Federal and regulatory requirements, and the Financial Report—Federal Cash requirements of this FOA. ANA’s Commissioner has discretion to make all Transaction Report to the Division of Payment Management on a quarterly final funding decisions. In the exercise basis. of such discretion, the Commissioner would consider whether the project: Lillian Sparks Robinson, 1. Would further the purpose of this Commissioner, Administration for Native funding opportunity as described in Americans. Section I. Description, or is likely to be [FR Doc. 2014–04959 Filed 3–6–14; 8:45 am] successful or cost effective based on BILLING CODE 4184–34–P what is submitted for evaluation in response to Section IV.2. Project Description. 2. Fails to provide documented commitment of non-federal cash contributions as described in Section III.2. Cost Sharing or Matching and Section IV.2. Project Description, Commitment of Non-Federal Resources. mstockstill on DSK4VPTVN1PROD with NOTICES previously listed and evaluated as part of the Approach section. They will be listed as separate criteria to highlight the critical nature of these elements to project success. Bonus Points that appeared in prior years’ FOAs will be removed from the evaluation criteria. 2. Titles and Assigned Weight: ANA would adjust the maximum point values of the evaluation criteria scores to further prioritize elements that are important to project monitoring and success. ANA proposes to use the following criteria values for the FY 2014 NABI FOA: Need for Assistance—15 points; Outcomes Expected—10 points; Project Approach—20 points; Organizational Capacity—25 points; Objective Work Plan—20 points; Budget and Budget Justification—10 points. 3. Scoring Guidance: ANA intends to provide guidance to reviewers to utilize the table below when allocating points for applications in order to ensure consistency and equivalence in scoring between different panels and panel reviewers. ANA would add the following table to all FY 2014 FOAs: VerDate Mar<15>2010 18:39 Mar 06, 2014 Jkt 232001 PO 00000 Frm 00028 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0191] Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. The Food and Drug Administration (FDA) is announcing the following public workshop entitled ‘‘Advancing Regulatory Science for High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers.’’ The purpose of the public workshop is to discuss the clinical and public health applications and performance validation of these devices, the quality criteria for establishing the accuracy of reference databases for regulatory use and ways to streamline clinical trials for microbial identification. This discussion is essential to establish the safety and effectiveness of high throughput sequencing devices when used to test human specimens or clinical isolates for the diagnosis of infectious diseases and detection of antimicrobial resistance markers. Date and Time: The public workshop will be held on April 1, 2014, from 9 a.m. to 4:30 p.m. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), 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. Contact Person: Heike Sichtig, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5269, Silver Spring, MD 20993–0002, email: Heike.Sichtig@fda.hhs.gov. Registration: Registration is free and on a first-come, first-served basis. Persons interested in attending this public workshop must register online by 5 p.m. on March 25, 2014. Early registration is recommended because seating is limited. FDA may limit the number of participants from each organization based on space limitations. DATES: E:\FR\FM\07MRN1.SGM 07MRN1 Federal Register / Vol. 79, No. 45 / Friday, March 7, 2014 / Notices Registrants will receive confirmation once their registration has been accepted. Onsite registration on the day of the public workshop will be provided on a space-available basis beginning at 7 a.m. 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, email: susan.monahan@fda.hhs.gov at least 7 days in advance of the workshop. 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 the appropriate meeting from the list). Please provide complete contact information for each attendee, including name, title, affiliation, email, and telephone number. If you are unable to register online, please contact Susan Monahan (301–796–5661, email: susan.monahan@fda.hhs.gov). Registration requests should be received by 5 p.m., March 25, 2014. In advance of the meeting, registered attendees will receive a draft of FDA’s proposed concept for the performance evaluation of High Throughput Sequencing Devices for Microbial Identification and Detection of Antimicrobial Resistance Markers. Additional information, including a workshop agenda, will be available at a later date. SUPPLEMENTARY INFORMATION: mstockstill on DSK4VPTVN1PROD with NOTICES I. Background High throughput sequencing devices for the diagnosis of infectious diseases, including detection of antimicrobial resistance markers, are a new generation of diagnostic products that have the capability to simultaneously identify and differentiate a large number of microbial pathogens using a single clinical specimen or clinical isolate. These devices have already emerged as a critical tool in many research areas and soon they will become both a fixture in clinical microbiology reference laboratories and a routine part of diagnostic laboratory workflows. Use of this technology requires a process of sample/library preparation, sequencing, and output de-convolution/results interpretation. The identification of the organism or resistance marker is often based on genomic sequence information in comparison to reference databases that were created by the device VerDate Mar<15>2010 18:39 Mar 06, 2014 Jkt 232001 13063 manufacturer or are otherwise publicly available. High throughput sequencing devices have the potential to dramatically change clinical microbiology. These diagnostic devices present several advantages, such as identifying potential disease etiology in situations where many different pathogens share a common clinical manifestation without the need for any a priori target specific information to select the appropriate test. However, the processes of selecting the methods used to establish and validate the performance of these devices to make informed clinical and public health decisions pose significant scientific and regulatory challenges. The purpose of the public workshop is to discuss the implementation of high throughput sequencing devices for the diagnosis of infectious disease. Specifically, the FDA seeks input from clinical laboratories, infectious disease physicians, industry, government, academia, and other stakeholders on the following topics: Clinical applications and public health needs; device performance validation; reference databases; and ways to streamline clinical evaluations/trials for microbial identification. This information is viewed as essential in establishing the safety and effectiveness of high throughput sequencing devices when used for the clinical diagnosis of infectious diseases and markers of antimicrobial resistance from human specimens or clinical isolates. default.htm (select the appropriate workshop from the list). II. Workshop Overview This public workshop will consist of brief presentations providing information to frame the goals of the workshop, and an interactive discussion. The presentations will focus on current and anticipated uses for high throughput sequencing devices, a proposal for the performance evaluation approach preferred by FDA, and information on the criteria for acceptable reference databases. Following the presentations there will be a moderated discussion where the participants will be asked to provide their individual perspectives. The outcome of the meeting will be captured and released as a draft guidance document. The draft guidance document is expected to be available at a later date. 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/ 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 (ELEM–1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857. PO 00000 Frm 00029 Fmt 4703 Sfmt 9990 III. Topics for Input FDA will seek input on its proposed performance evaluation approach, which will include the following topics: 1. Clinical applications and public health needs: Identify specific applications where high throughput sequencing could be used for diagnosis of infectious diseases and markers of antimicrobial resistance from human specimens or clinical isolates. 2. Device validation: Develop and adapt standards for the microbial genome sequencing process (from sample collection to result reporting), discuss best practices for sample/library preparation, variant identification, genome annotation, output deconvolution/results interpretation, and reporting. 3. Reference databases: Develop quality criteria to establish accurate reference databases, methods for curating, maintaining, and updating these databases. 4. Streamline clinical evaluations/ trials for microbial identification: Establish a new comparator paradigm for high throughput sequencing as the reference method to augment or replace existing reference testing methods. IV. Transcripts Dated: February 28, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–04940 Filed 3–6–14; 8:45 am] BILLING CODE 4160–01–P E:\FR\FM\07MRN1.SGM 07MRN1

Agencies

[Federal Register Volume 79, Number 45 (Friday, March 7, 2014)]
[Notices]
[Pages 13062-13063]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-04940]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0191]


Advancing Regulatory Science for High Throughput Sequencing 
Devices for Microbial Identification and Detection of Antimicrobial 
Resistance Markers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

-----------------------------------------------------------------------

    The Food and Drug Administration (FDA) is announcing the following 
public workshop entitled ``Advancing Regulatory Science for High 
Throughput Sequencing Devices for Microbial Identification and 
Detection of Antimicrobial Resistance Markers.'' The purpose of the 
public workshop is to discuss the clinical and public health 
applications and performance validation of these devices, the quality 
criteria for establishing the accuracy of reference databases for 
regulatory use and ways to streamline clinical trials for microbial 
identification. This discussion is essential to establish the safety 
and effectiveness of high throughput sequencing devices when used to 
test human specimens or clinical isolates for the diagnosis of 
infectious diseases and detection of antimicrobial resistance markers.

DATES: Date and Time: The public workshop will be held on April 1, 
2014, from 9 a.m. to 4:30 p.m.
    Location: The public workshop will be held at the FDA White Oak 
Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the 
Great Room (Rm. 1503), 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.
    Contact Person: Heike Sichtig, Center for Devices and Radiological 
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
66, Rm. 5269, Silver Spring, MD 20993-0002, email: 
Heike.Sichtig@fda.hhs.gov.
    Registration: Registration is free and on a first-come, first-
served basis. Persons interested in attending this public workshop must 
register online by 5 p.m. on March 25, 2014. Early registration is 
recommended because seating is limited. FDA may limit the number of 
participants from each organization based on space limitations.

[[Page 13063]]

Registrants will receive confirmation once their registration has been 
accepted. Onsite registration on the day of the public workshop will be 
provided on a space-available basis beginning at 7 a.m.
    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, email: 
susan.monahan@fda.hhs.gov at least 7 days in advance of the workshop.
    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 the appropriate meeting from the list). Please provide complete 
contact information for each attendee, including name, title, 
affiliation, email, and telephone number. If you are unable to register 
online, please contact Susan Monahan (301-796-5661, email: 
susan.monahan@fda.hhs.gov). Registration requests should be received by 
5 p.m., March 25, 2014.
    In advance of the meeting, registered attendees will receive a 
draft of FDA's proposed concept for the performance evaluation of High 
Throughput Sequencing Devices for Microbial Identification and 
Detection of Antimicrobial Resistance Markers. Additional information, 
including a workshop agenda, will be available at a later date.

SUPPLEMENTARY INFORMATION:

I. Background

    High throughput sequencing devices for the diagnosis of infectious 
diseases, including detection of antimicrobial resistance markers, are 
a new generation of diagnostic products that have the capability to 
simultaneously identify and differentiate a large number of microbial 
pathogens using a single clinical specimen or clinical isolate. These 
devices have already emerged as a critical tool in many research areas 
and soon they will become both a fixture in clinical microbiology 
reference laboratories and a routine part of diagnostic laboratory 
workflows. Use of this technology requires a process of sample/library 
preparation, sequencing, and output de-convolution/results 
interpretation. The identification of the organism or resistance marker 
is often based on genomic sequence information in comparison to 
reference databases that were created by the device manufacturer or are 
otherwise publicly available.
    High throughput sequencing devices have the potential to 
dramatically change clinical microbiology. These diagnostic devices 
present several advantages, such as identifying potential disease 
etiology in situations where many different pathogens share a common 
clinical manifestation without the need for any a priori target 
specific information to select the appropriate test. However, the 
processes of selecting the methods used to establish and validate the 
performance of these devices to make informed clinical and public 
health decisions pose significant scientific and regulatory challenges.
    The purpose of the public workshop is to discuss the implementation 
of high throughput sequencing devices for the diagnosis of infectious 
disease. Specifically, the FDA seeks input from clinical laboratories, 
infectious disease physicians, industry, government, academia, and 
other stakeholders on the following topics: Clinical applications and 
public health needs; device performance validation; reference 
databases; and ways to streamline clinical evaluations/trials for 
microbial identification. This information is viewed as essential in 
establishing the safety and effectiveness of high throughput sequencing 
devices when used for the clinical diagnosis of infectious diseases and 
markers of antimicrobial resistance from human specimens or clinical 
isolates.

II. Workshop Overview

    This public workshop will consist of brief presentations providing 
information to frame the goals of the workshop, and an interactive 
discussion. The presentations will focus on current and anticipated 
uses for high throughput sequencing devices, a proposal for the 
performance evaluation approach preferred by FDA, and information on 
the criteria for acceptable reference databases. Following the 
presentations there will be a moderated discussion where the 
participants will be asked to provide their individual perspectives. 
The outcome of the meeting will be captured and released as a draft 
guidance document.
    The draft guidance document is expected to be available at a later 
date. 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 workshop from 
the list).

III. Topics for Input

    FDA will seek input on its proposed performance evaluation 
approach, which will include the following topics:
    1. Clinical applications and public health needs: Identify specific 
applications where high throughput sequencing could be used for 
diagnosis of infectious diseases and markers of antimicrobial 
resistance from human specimens or clinical isolates.
    2. Device validation: Develop and adapt standards for the microbial 
genome sequencing process (from sample collection to result reporting), 
discuss best practices for sample/library preparation, variant 
identification, genome annotation, output de-convolution/results 
interpretation, and reporting.
    3. Reference databases: Develop quality criteria to establish 
accurate reference databases, methods for curating, maintaining, and 
updating these databases.
    4. Streamline clinical evaluations/trials for microbial 
identification: Establish a new comparator paradigm for high throughput 
sequencing as the reference method to augment or replace existing 
reference testing methods.

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 (ELEM-1029), Food 
and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, 
MD 20857.

    Dated: February 28, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04940 Filed 3-6-14; 8:45 am]
BILLING CODE 4160-01-P

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