Center for Devices and Radiological Health: Experiential Learning Program, 24729-24731 [2014-09916]

Download as PDF Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices Remaining Operating Rules; and (3) A letter emphasizing NCVHS’s long-standing position on the adoption of ICD–10 code sets in the US. Contact Person for More Information: Debbie Jackson, Interim Executive Secretary, NCVHS, National Center for Health Statistics, Centers for Disease Control and Prevention, 3311 Toledo Road, Room 2402, Hyattsville, Maryland 20782, telephone (301) 458–4614; Written comments should be sent directly to Terri Deutsch, lead staff for the Standards Subcommittee, NCVHS, Centers for Medicare and Medicaid Services, Office of E-Health Standards and Services, 7500 Security Boulevard, Mailstop S2–26–17, Baltimore, Maryland 21244, email Terri.Deutsch@ cms.hhs.gov, phone (410) 786–9462. Program information as well as summaries of meetings and a roster of committee members are available on the NCVHS home page of the HHS Web site: https:// www.ncvhs.hhs.gov/, where further information including an agenda will be posted when available. Dated: April 23, 2014. James Scanlon, Deputy Assistant Secretary for Planning and Evaluation, Office of the Assistant Secretary for Planning and, Evaluation. [FR Doc. 2014–09903 Filed 4–30–14; 8:45 am] Biologics’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0765. The approval expires on March 31, 2017. A copy of the supporting statement for this information collection is available on the Internet at https://www.reginfo.gov/ public/do/PRAMain. Dated: April 25, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09914 Filed 4–30–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1394] Food and Drug Administration, HHS. [Docket No. FDA–2013–D–0575] ACTION: Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Expedited Programs for Serious Conditions— Drugs and Biologics SUMMARY: AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and Biologics’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On December 31, 2013, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry on Expedited Programs for Serious Conditions—Drugs and tkelley on DSK3SPTVN1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 17:30 Apr 30, 2014 Jkt 232001 Dated: April 25, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09913 Filed 4–30–14; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0338] Center for Devices and Radiological Health: Experiential Learning Program AGENCY: ACTION: DEPARTMENT OF HEALTH AND HUMAN SERVICES AGENCY: Food and Drug Administration the Internet at https://www.reginfo.gov/ public/do/PRAMain. Notice. The Food and Drug Administration (FDA) is announcing that a collection of information entitled ‘‘Guidance for Industry on Special Protocol Assessment’’ has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 1350 Piccard Dr., PI50–400B, Rockville, MD 20850, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: On February 19, 2014, the Agency submitted a proposed collection of information entitled ‘‘Guidance for Industry on Special Protocol Assessment’’ to OMB for review and clearance under 44 U.S.C. 3507. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. OMB has now approved the information collection and has assigned OMB control number 0910–0470. The approval expires on March 31, 2017. A copy of the supporting statement for this information collection is available on PO 00000 Frm 00063 Fmt 4703 Food and Drug Administration, HHS. Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; Guidance for Industry on Special Protocol Assessment BILLING CODE 4151–05–P 24729 Sfmt 4703 Notice. The Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing an invitation for participation in its Experiential Learning Program (ELP). The ELP provides a formal training mechanism for regulatory review staff to visit research, clinical, manufacturing, and health care facilities to observe firsthand how medical devices are designed, developed, and utilized. This training is intended to provide CDRH staff with an opportunity to observe the device development life cycle and provide a better understanding of the medical devices they review and the challenges faced throughout development, testing, manufacturing, and clinical use. The purpose of this document is to invite medical device industry, academia, and health care facilities to participate in this formal training program for FDA’s medical device review staff, or to contact CDRH for more information regarding the program. DATES: Submit either an electronic or written request for participation in this program by June 2, 2014. The request should include a description of your facility relative to product areas regulated by CDRH. Please include the Area of Interest (see table 1 or 2) that the site visit will demonstrate to CDRH staff, a contact person, site visit location, length of site visit, proposed dates, and maximum number of CDRH staff that can be accommodated during a site visit. Submitted proposals without this information will not be considered. In addition, please include an agenda outlining the proposed training for the site visit. A sample request and agenda are available on the ELP Web site: https://www.fda.gov/downloads/ ScienceResearch/ SUMMARY: E:\FR\FM\01MYN1.SGM 01MYN1 24730 Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices ScienceCareerOpportunities/ UCM392988.pdf and https:// www.fda.gov/scienceresearch/ sciencecareeropportunities/ ucm380676.htm. ADDRESSES: Submit either electronic requests to https://www.regulations.gov or written requests to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Latonya Powell, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4448, Silver Spring, MD 20993–0002, 301–796–6965, FAX: 301–827–3079, Latonya.powell@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background CDRH launched the ELP Pilot in 2012 and fully implemented the program (78 FR 19711, April 2, 2013) in 2013. The Center is responsible for ensuring the safety and effectiveness of medical devices marketed in the United States. Furthermore, CDRH assures that patients and providers have timely and continued access to high-quality, safe, and effective medical devices and safe radiation-emitting products. In support of this mission, the Center launched various training and development initiatives to enhance performance of its staff involved in regulatory review and in the premarket review process. CDRH is committed to advancing regulatory science; providing industry with predictable, consistent, transparent, and efficient regulatory pathways; and helping to ensure consumer confidence in medical devices marketed in the United States and throughout the world. This program is a collaborative effort to enhance communication and facilitate the premarket review process. Furthermore, CDRH is committed to understanding current industry practices, innovative technologies, and regulatory impacts and needs. These formal training visits are not a mechanism for FDA to inspect, assess, judge, or perform a regulatory function (i.e., compliance inspection), but rather, are an opportunity to provide the CDRH review staff a better understanding of the products they review. Through this notice, CDRH is formally requesting participation from companies; academia; and clinical facilities, including those that have previously participated in the ELP; other FDA site visit programs; and new interested parties. II. ELP A. Experiential Learning Program In this program, groups of CDRH staff will observe operations of medical device establishments, including research, manufacturing, academia, and health care facilities. The areas of focus and specific areas of interest for visits may include the following: TABLE 1—AREAS OF INTEREST—MEDICAL DEVICES/TECHNOLOGY Focus area Specific areas of interest Advanced simulation testing of mechanical ventilators ........................... Performance testing of closed loop controlled ventilators using advanced physiologic simulation and computational modeling of the system (patient, ventilator, and sensor). Structure and organization of an ART clinic; understanding the necessary specifications for ART devices (incubators, microscopes, media, micromanipulation, assisted reproduction lasers, and lab ware); cleaning and disinfection of reprocessed instruments in the ART clinic; aseptic techniques used in ART clinic. Observation of surgical procedures (posterolateral spine fusion, foot, ankle) utilizing bone void fillers. Rehabilitation hospitals and programs; devices for treatment of pain (transcutaneous electrical nerve stimulator, diathermy), devices for muscle rehabilitation (powered muscle stimulators), devices intended to help restore function to patients (prosthetic limbs, functional electrical stimulators, orthoses). Tumor ablation devices. Assisted reproductive technology (ART) clinic setting ............................. Clinical use of orthopedic bone void filler devices ................................... Clinical use of physical medicine devices ................................................ Design and development of ablation devices, including electrosurgical units and accessories, electrosurgical/ultrasonic devices, microwave ablation devices. Electrophysiology (EP) catheters for diagnostic (mapping) and therapeutic (ablation) indications. Emerging manufacturing methods for orthopedic devices ....................... Endosseous implants ............................................................................... tkelley on DSK3SPTVN1PROD with NOTICES Hemodialysis devices used in the home environment ............................. Interface between the brain thought processes and the movement of medical devices to assist mobility. Intraocular lenses (IOLs) and injectors .................................................... Manufacturing of polymeric sealants ........................................................ Refractive lasers ....................................................................................... Robotic surgery ........................................................................................ VerDate Mar<15>2010 17:30 Apr 30, 2014 Jkt 232001 PO 00000 Frm 00064 Fmt 4703 Observe manufacturing and testing of EP devices, with inclusion of design verification and returned product testing, as available. 3D printing, rapid manufacturing. Computer Aided Design/Computer Aided Manufacturers produced elements, titanium bases, and various software programs utilized for forming abutments. Home hemodialysis training program, hemodialysis machines, ‘‘wetness’’ detectors, hemodialysis blood access devices, water treatment. Brain-computer interface manufacturer or laboratory. Development and manufacture of IOLs and injectors. Vascular surgical sealants. Manufacturing; preclinical testing; femtosecond lasers. Manufacturing of robotic surgical devices. Sfmt 4703 E:\FR\FM\01MYN1.SGM 01MYN1 Federal Register / Vol. 79, No. 84 / Thursday, May 1, 2014 / Notices 24731 TABLE 2—AREAS OF INTEREST—IN VITRO DIAGNOSTIC AND RADIOLOGICAL DEVICES/TECHNOLOGY Focus area Specific areas of interest Artificial pancreas related devices ............................................................ Manufacturing of continuous glucose monitoring devices and insulin pumps. Manufacturing of antibodies (monoclonal and polyclonal) for immunoassay tests. Coagulation devices for point of care and home use (COUMADIN selfmonitoring) utilizing whole blood and/or citrated plasma. Immunohistochemistry as an important tool in biomarkers detection and clinical practice. Systems maintaining quality oversight of data generated at a distant location and transmitted digitally to another location for analysis. Manufacturing of different types of human antibodies for the use of immunoassays. Coagulation point of care and home use devices ................................... Immunohistochemistry for the diagnostic evaluation for cancer .............. Systems capable of running multiple analytes composed of a specimen collection and processing unit at satellite locations and data transmittal to a central location for analysis and quality control oversight. Antimicrobial resistance detection and characterization .......................... Diagnostic x-ray imaging devices ............................................................. Next generation sequencing/single-nucleotide polymorphism (SNP) arrays and clinical genomics. B. Site Selection CDRH will be responsible for all CDRH staff travel expenses associated with the site visits. CDRH cannot provide funds to support the proposed training provided by the applicants to this program. Selection of potential facilities will be based on CDRH’s priorities for staff training and resources available to fund this program. In addition to logistical and other resource factors, all sites must have a successful compliance record with FDA or another Agency with which FDA has a memorandum of understanding. If a site visit involves a visit to a separate physical location of another firm under contract to the applicant, that firm must agree to participate in the program and must also have a satisfactory compliance history. III. Request for Participation Identify requests for participation with the docket number found in the brackets in the heading of this document. Received requests may be seen in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Dated: April 25, 2014. Leslie Kux, Assistant Commissioner for Policy. [FR Doc. 2014–09916 Filed 4–30–14; 8:45 am] tkelley on DSK3SPTVN1PROD with NOTICES BILLING CODE 4160–01–P VerDate Mar<15>2010 17:30 Apr 30, 2014 Jkt 232001 Observation and hands-on experience with reference methods and assays for phenotypic and non-phenotypic-based methods for determining antimicrobial resistance. Site visits to user facilities. Next generation sequencing and/or SNP array devices in the clinical laboratory setting for molecular diagnostics used. DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2009–N–0458] Providing Information About Pediatric Uses of Medical Devices; Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled ‘‘Providing Information about Pediatric Uses of Medical Devices.’’ FDA is issuing this guidance document to describe how to compile and submit the readily available pediatric use information required under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). DATES: Submit either electronic or written comments on this guidance at any time. General comments on Agency guidance documents are welcome at any time. ADDRESSES: An electronic copy of the guidance document is available for download from the Internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the guidance document entitled ‘‘Providing Information About Pediatric Uses of Medical Devices’’ to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health (CDRH), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993–0002 or Office SUMMARY: PO 00000 Frm 00065 Fmt 4703 Sfmt 4703 of Communication, Outreach and Development (HFM–40), Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852–1448. Send one self-addressed adhesive label to assist that office in processing your request. Submit electronic comments on the guidance 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. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Sheila Brown, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1651, Silver Spring, MD 20993–0002, 301–796–6563; or Stephen Ripley, Center for Biologics Evaluation and Research (HFM–17), Food and Drug Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852, 301–827–6210. I. Background On September 27, 2007, the Food and Drug Administration Amendments Act of 2007 (FDAAA) 1 (Pub. L. 110–85) amended the FD&C Act by adding, among other things, a new section 515A (21 U.S.C. 360e–1) of the FD&C Act. Section 515A(a) of the FD&C Act requires persons who submit certain medical device applications to include, if readily available: (1) A description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or 1 Title III of FDAAA, which includes new section 515A, is also known as the Pediatric Medical Device Safety and Improvement Act of 2007. E:\FR\FM\01MYN1.SGM 01MYN1

Agencies

[Federal Register Volume 79, Number 84 (Thursday, May 1, 2014)]
[Notices]
[Pages 24729-24731]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2014-09916]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0338]


Center for Devices and Radiological Health: Experiential Learning 
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) Center for Devices and 
Radiological Health (CDRH or Center) is announcing an invitation for 
participation in its Experiential Learning Program (ELP). The ELP 
provides a formal training mechanism for regulatory review staff to 
visit research, clinical, manufacturing, and health care facilities to 
observe firsthand how medical devices are designed, developed, and 
utilized. This training is intended to provide CDRH staff with an 
opportunity to observe the device development life cycle and provide a 
better understanding of the medical devices they review and the 
challenges faced throughout development, testing, manufacturing, and 
clinical use. The purpose of this document is to invite medical device 
industry, academia, and health care facilities to participate in this 
formal training program for FDA's medical device review staff, or to 
contact CDRH for more information regarding the program.

DATES: Submit either an electronic or written request for participation 
in this program by June 2, 2014. The request should include a 
description of your facility relative to product areas regulated by 
CDRH. Please include the Area of Interest (see table 1 or 2) that the 
site visit will demonstrate to CDRH staff, a contact person, site visit 
location, length of site visit, proposed dates, and maximum number of 
CDRH staff that can be accommodated during a site visit. Submitted 
proposals without this information will not be considered. In addition, 
please include an agenda outlining the proposed training for the site 
visit. A sample request and agenda are available on the ELP Web site: 
https://www.fda.gov/downloads/ScienceResearch/

[[Page 24730]]

ScienceCareerOpportunities/UCM392988.pdf and https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

ADDRESSES: Submit either electronic requests to https://www.regulations.gov or written requests to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Latonya Powell, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4448, Silver Spring, MD 20993-0002, 301-796-6965, 
FAX: 301-827-3079, Latonya.powell@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    CDRH launched the ELP Pilot in 2012 and fully implemented the 
program (78 FR 19711, April 2, 2013) in 2013. The Center is responsible 
for ensuring the safety and effectiveness of medical devices marketed 
in the United States. Furthermore, CDRH assures that patients and 
providers have timely and continued access to high-quality, safe, and 
effective medical devices and safe radiation-emitting products. In 
support of this mission, the Center launched various training and 
development initiatives to enhance performance of its staff involved in 
regulatory review and in the premarket review process. CDRH is 
committed to advancing regulatory science; providing industry with 
predictable, consistent, transparent, and efficient regulatory 
pathways; and helping to ensure consumer confidence in medical devices 
marketed in the United States and throughout the world. This program is 
a collaborative effort to enhance communication and facilitate the 
premarket review process. Furthermore, CDRH is committed to 
understanding current industry practices, innovative technologies, and 
regulatory impacts and needs.
    These formal training visits are not a mechanism for FDA to 
inspect, assess, judge, or perform a regulatory function (i.e., 
compliance inspection), but rather, are an opportunity to provide the 
CDRH review staff a better understanding of the products they review. 
Through this notice, CDRH is formally requesting participation from 
companies; academia; and clinical facilities, including those that have 
previously participated in the ELP; other FDA site visit programs; and 
new interested parties.

II. ELP

A. Experiential Learning Program

    In this program, groups of CDRH staff will observe operations of 
medical device establishments, including research, manufacturing, 
academia, and health care facilities. The areas of focus and specific 
areas of interest for visits may include the following:

         Table 1--Areas of Interest--Medical Devices/Technology
------------------------------------------------------------------------
               Focus area                   Specific areas of interest
------------------------------------------------------------------------
Advanced simulation testing of           Performance testing of closed
 mechanical ventilators.                  loop controlled ventilators
                                          using advanced physiologic
                                          simulation and computational
                                          modeling of the system
                                          (patient, ventilator, and
                                          sensor).
Assisted reproductive technology (ART)   Structure and organization of
 clinic setting.                          an ART clinic; understanding
                                          the necessary specifications
                                          for ART devices (incubators,
                                          microscopes, media,
                                          micromanipulation, assisted
                                          reproduction lasers, and lab
                                          ware); cleaning and
                                          disinfection of reprocessed
                                          instruments in the ART clinic;
                                          aseptic techniques used in ART
                                          clinic.
Clinical use of orthopedic bone void     Observation of surgical
 filler devices.                          procedures (posterolateral
                                          spine fusion, foot, ankle)
                                          utilizing bone void fillers.
Clinical use of physical medicine        Rehabilitation hospitals and
 devices.                                 programs; devices for
                                          treatment of pain
                                          (transcutaneous electrical
                                          nerve stimulator, diathermy),
                                          devices for muscle
                                          rehabilitation (powered muscle
                                          stimulators), devices intended
                                          to help restore function to
                                          patients (prosthetic limbs,
                                          functional electrical
                                          stimulators, orthoses).
Design and development of ablation       Tumor ablation devices.
 devices, including electrosurgical
 units and accessories, electrosurgical/
 ultrasonic devices, microwave ablation
 devices.
Electrophysiology (EP) catheters for     Observe manufacturing and
 diagnostic (mapping) and therapeutic     testing of EP devices, with
 (ablation) indications.                  inclusion of design
                                          verification and returned
                                          product testing, as available.
Emerging manufacturing methods for       3D printing, rapid
 orthopedic devices.                      manufacturing.
Endosseous implants....................  Computer Aided Design/Computer
                                          Aided Manufacturers produced
                                          elements, titanium bases, and
                                          various software programs
                                          utilized for forming
                                          abutments.
Hemodialysis devices used in the home    Home hemodialysis training
 environment.                             program, hemodialysis
                                          machines, ``wetness''
                                          detectors, hemodialysis blood
                                          access devices, water
                                          treatment.
Interface between the brain thought      Brain-computer interface
 processes and the movement of medical    manufacturer or laboratory.
 devices to assist mobility.
Intraocular lenses (IOLs) and injectors  Development and manufacture of
                                          IOLs and injectors.
Manufacturing of polymeric sealants....  Vascular surgical sealants.
Refractive lasers......................  Manufacturing; preclinical
                                          testing; femtosecond lasers.
Robotic surgery........................  Manufacturing of robotic
                                          surgical devices.
------------------------------------------------------------------------


[[Page 24731]]


Table 2--Areas of Interest--In Vitro Diagnostic and Radiological Devices/
                               Technology
------------------------------------------------------------------------
               Focus area                   Specific areas of interest
------------------------------------------------------------------------
Artificial pancreas related devices....  Manufacturing of continuous
                                          glucose monitoring devices and
                                          insulin pumps.
Manufacturing of different types of      Manufacturing of antibodies
 human antibodies for the use of          (monoclonal and polyclonal)
 immunoassays.                            for immunoassay tests.
Coagulation point of care and home use   Coagulation devices for point
 devices.                                 of care and home use (COUMADIN
                                          self-monitoring) utilizing
                                          whole blood and/or citrated
                                          plasma.
Immunohistochemistry for the diagnostic  Immunohistochemistry as an
 evaluation for cancer.                   important tool in biomarkers
                                          detection and clinical
                                          practice.
Systems capable of running multiple      Systems maintaining quality
 analytes composed of a specimen          oversight of data generated at
 collection and processing unit at        a distant location and
 satellite locations and data             transmitted digitally to
 transmittal to a central location for    another location for analysis.
 analysis and quality control oversight.
Antimicrobial resistance detection and   Observation and hands-on
 characterization.                        experience with reference
                                          methods and assays for
                                          phenotypic and non-phenotypic-
                                          based methods for determining
                                          antimicrobial resistance.
Diagnostic x-ray imaging devices.......  Site visits to user facilities.
Next generation sequencing/single-       Next generation sequencing and/
 nucleotide polymorphism (SNP) arrays     or SNP array devices in the
 and clinical genomics.                   clinical laboratory setting
                                          for molecular diagnostics
                                          used.
------------------------------------------------------------------------

B. Site Selection

    CDRH will be responsible for all CDRH staff travel expenses 
associated with the site visits. CDRH cannot provide funds to support 
the proposed training provided by the applicants to this program. 
Selection of potential facilities will be based on CDRH's priorities 
for staff training and resources available to fund this program. In 
addition to logistical and other resource factors, all sites must have 
a successful compliance record with FDA or another Agency with which 
FDA has a memorandum of understanding. If a site visit involves a visit 
to a separate physical location of another firm under contract to the 
applicant, that firm must agree to participate in the program and must 
also have a satisfactory compliance history.

III. Request for Participation

    Identify requests for participation with the docket number found in 
the brackets in the heading of this document. Received requests may be 
seen in the Division of Dockets Management (see ADDRESSES) between 9 
a.m. and 4 p.m., Monday through Friday.

    Dated: April 25, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-09916 Filed 4-30-14; 8:45 am]
BILLING CODE 4160-01-P
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.