Center for Devices and Radiological Health: Experiential Learning Program, 19711-19713 [2013-07593]

Download as PDF Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices health of American women by advancing and coordinating a comprehensive women’s health agenda throughout HHS. The office fulfills its mission by advancing policy and issuing competitive contracts to an array of community, academic, and other organizations at the national and community levels. In addition, OWH’s national educational campaigns provide information about the important steps women can take to improve and maintain their health, such as NWHW. NWHW is a week-long health observance that kicks off on Mother’s Day, Sunday, May 12 and ends Saturday, May 18, 2013. NWHW seeks to educate women about improving their physical and mental health and preventing disease. More than 2,200 events were held nationwide in 2012. Week-long, daily messages encourage women to make their health a top priority and take simple steps for a longer, healthier, and happier life. For more information about NWHW, please visit http://womenshealth.gov/nwhw/. Dated: March 27, 2013. Nancy C. Lee, Deputy Assistant Secretary for Health— Women’s Health. [FR Doc. 2013–07617 Filed 4–1–13; 8:45 am] BILLING CODE 4150–33–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention srobinson on DSK4SPTVN1PROD with NOTICES Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772–76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 78 FR 5812, dated January 28, 2013) is amended to reflect the reorganization of the Office for State, Tribal, Local, and Territorial Support. Section C–B, Organization and Functions, is hereby amended as follows: Delete in its entirety the title and function statements for the Knowledge Management Office (CQA5), Office of the Director (CQA). Revise the functional statement for the Public Health Law Office (CQA2), Office of the Director (CQA) as follows: After item (8), insert the following: (9) establish collaboration and coordination between clinical medicine and public VerDate Mar<15>2010 19:35 Apr 01, 2013 Jkt 229001 health to better coordinate and partner for healthier communities. Dated: March 22, 2013. Sherri A. Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2013–07582 Filed 4–1–13; 8:45 am] BILLING CODE 4160–18–M DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Statement of Organization, Functions, and Delegations of Authority Part C (Centers for Disease Control and Prevention) of the Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (45 FR 67772–76, dated October 14, 1980, and corrected at 45 FR 69296, October 20, 1980, as amended most recently at 78 FR 5812, dated January 28, 2013) is amended to reflect the reorganization of the Office of the Associate Director for Science, Office of the Director, Centers for Disease Control and Prevention. Section C–B, Organization and Functions, is hereby amended as follows: Delete in its entirety the title and function statements for the Public Health Prevention Service Branch (CPLCC), Division of Leadership and Practice (CPLP). Dated: March 22, 2013. Sherri A. Berger, Chief Operating Officer, Centers for Disease Control and Prevention. [FR Doc. 2013–07545 Filed 4–1–13; 8:45 am] BILLING CODE 4160–18–M 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. The Food and Drug Administration’s (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 SUMMARY: PO 00000 Frm 00075 Fmt 4703 Sfmt 4703 19711 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 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 May 2, 2013. The request should include a description of your facility relative to product areas CDRH regulates. Please include the Area of Interest/Medical Device or Technology (identified in table 1or 2) that the visit will demonstrate to CDRH staff. ADDRESSES: Submit either electronic requests to http://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 will fully implement the program 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 safe, effective, highquality 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 regulatory review staff and other staff involved in the premarket review process. CDRH is driven to advance regulatory science; provide industry with predictable, consistent, transparent, and efficient regulatory pathways; and assure consumer E:\FR\FM\02APN1.SGM 02APN1 19712 Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices 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. This request includes those that have previously participated in the ELP or other FDA Site Visit programs, as well as 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 Performance validation and reliability testing of intensive care unit ventilator and anesthesia gas machines. Implantation techniques for spinal devices .................................. Ventilators, continuous positive airway pressure devices, anesthesia gas machines, and closed-loop ventilators. Implantation training and assessment using cadavers and direct observation of surgical procedures for spinal implants including, but not limited to, lateral intervertebral body fusion devices, minimally invasive pedicle screw systems, and spinous process plates. All joint replacement devices. Manufacturing of ultra-high molecular weight polyethylene device components. Clinical use of orthopedic bone void filler devices ....................... Reprocessing methods and techniques in the clinical environment. Bariatric surgery ............................................................................ Manufacturing and assessment of hemodialyzers and filters ...... Sourcing and manufacturing of animal-derived collagen ............. Traumatic wound care, management, and treatment .................. Clinical use of plastic and reconstructive devices ........................ Treatment of acute ischemic stroke ............................................. Clinical use of neurosurgical monitoring devices ......................... Clinical use of rehabilitation devices ............................................ Clinical use of cardiovascular devices ......................................... Manufacturing of cardiovascular devices ..................................... Animal testing for chronic care cardiovascular devices ............... Manufacturing of contact lenses and care products .................... Treatment of severe hearing loss ................................................. Auditory brainstem implants (ABIs) .............................................. Management of clinical trials for medical devices ........................ Observation of surgical procedures (posterolateral spine fusion, foot, ankle) utilizing bone void fillers. Cleaning and sterilization methods and techniques for endoscopes (including colonoscopes, duodenoscopes, cystoscopes, etc.) and accessories; automatic endoscope reprocessors. Observation of bariatric surgical techniques, with and without bariatric devices. Hemodialyzers, hemofilters, hemoconcentrators, ultrafilters, and plasma filters. Surgical meshes, wound dressings. Observation of clinical uses of wound management/treatment devices and hemostatic products for use on traumatic injuries. Observation of surgical procedures utilizing surgical meshes, dermal fillers, hemostatic agents, and bone waxes. Clot retrieval procedures, clot retrieval devices and ancillary products (medications, angiograms), stroke centers, and acute stroke care programs. Neuro-evoked response devices that are used for real-time monitoring of patients undergoing a back procedure. Clinical use of physical medicine devices (prostheses, pressure-relieving seat cushions, tilt-in-space wheelchairs, and devices for pain relief) in a rehabilitation center setting for treatment of various conditions (e.g., spinal cord injuries, traumatic brain injuries, and amputations). Endovascular stent grafts and associated delivery systems; Stents and associated delivery systems. Drug coated devices (e.g., stents and balloons), endovascular stent grafts and associated delivery systems, stents and associated delivery systems, percutaneous heart valves. Observation of surgical procedures and chronic care maintenance in animal models using chronic care cardiovascular devices, such as heart valves and ventricular assist devices. All contact lenses and care products. Surgical implantation of cochlear implants, electro-acoustic stimulation using hybrid cochlear implants, preservation of residual hearing, postoperative evaluation of residual hearing and implant performance. Observation of ABI surgical procedures. Understanding clinical trial infrastructure, roles/responsibilities of your organization, and relationships with other organizations involved in the management and conduct of clinical trials; institutional review boards; clinical research organizations. srobinson on DSK4SPTVN1PROD with NOTICES TABLE 2—AREAS OF INTEREST—IN VITRO DIAGNOSTIC DEVICES/TECHNOLOGY Focus area Specific areas of interest Manufacturing and development of molecular/immunology devices. Manufacturing, development, and assessment of cytology/pathology devices. Manufacturing of microbiology devices ........................................ VerDate Mar<15>2010 19:35 Apr 01, 2013 Jkt 229001 PO 00000 Frm 00076 Molecular diagnostics devices, and companion diagnostics devices. Semiautomated cytology screening devices; cytology collection devices use in human papillomavirus tests; immunohistochemistry tests development in clinical trials. Antimicrobial susceptibility devices. Fmt 4703 Sfmt 4703 E:\FR\FM\02APN1.SGM 02APN1 Federal Register / Vol. 78, No. 63 / Tuesday, April 2, 2013 / Notices 19713 TABLE 2—AREAS OF INTEREST—IN VITRO DIAGNOSTIC DEVICES/TECHNOLOGY—Continued Focus area Specific areas of interest Manufacturing of chemistry devices ............................................. Clinical Laboratory Improvement Amendments (CLIA) waived devices, blood collection tubes, fecal occult blood devices. Hematology analyzers (specific interest in new technology). Coagulation assays and controls, platelet aggregatometers devices, prothrombin time/international normalized ratio meters and assays, D-Dimer analyzers and assays. Observation of testing in a clinical testing environment. Manufacturing and development of hematology devices ............. Manufacturing and development of coagulation devices ............. Observation of clinical testing in a CLIA high complexity laboratory. B. Site Selection CDRH will be responsible for all travel expenses associated with the site visits. Therefore, selection of potential facilities will be based on the coordination of CDRH’s priorities for staff training and the resources available for 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. public docket for interested parties to submit to FDA comments on the Institute of Medicine’s (IOM) recommendation regarding third-party governance of industry-sponsored tobacco product research. DATES: Submit electronic or written comments by September 30, 2013. ADDRESSES: You may submit comments, identified by Docket No. FDA–2013–N– 0305, by any of the following methods: III. Request for Participation Identify requests for participation with the docket number found in the brackets in the heading of this document. Received requests are available for public examination in the Division of Dockets Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday. Written Submissions Submit written submissions in the following ways: • Mail/Hand delivery/Courier (for paper or CD–ROM submissions): Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Instructions: All submissions received must include the Agency name and Docket No. FDA–2013–N–0305. All comments received may be posted without change to http:// www.regulations.gov, including any personal information provided. For additional information on submitting comments, see the ‘‘Comments’’ heading of the SUPPLEMENTARY INFORMATION section of this document. Docket: For access to the docket to read 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: Laila Noory, Center for Tobacco Products, Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 1–877–287–1373 (choose Option 4), FAX: 240–276–3761, email: CTP.3PGovernance@fda.hhs.gov. Dated: March 28, 2013. Peter Lurie, Acting Associate Commissioner for Policy and Planning. [FR Doc. 2013–07593 Filed 4–1–13; 8:45 am] BILLING CODE 4160–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–0305] srobinson on DSK4SPTVN1PROD with NOTICES Possible Role of Independent Third Parties in Industry-Sponsored Tobacco Product Research; Establishment of a Public Docket; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice; establishment of docket; request for data, information, and comments. ACTION: The Food and Drug Administration (FDA) is establishing a SUMMARY: VerDate Mar<15>2010 19:35 Apr 01, 2013 Jkt 229001 Electronic Submissions Submit electronic comments in the following way: • Electronic Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. PO 00000 Frm 00077 Fmt 4703 Sfmt 4703 SUPPLEMENTARY INFORMATION: I. Background On June 22, 2009, President Obama signed into law the Family Smoking Prevention and Tobacco Control Act (Pub. L. 111–31) (Tobacco Control Act). The Tobacco Control Act amends the Federal Food, Drug, and Cosmetic Act (the FD&C Act) by adding chapter IX (21 U.S.C. 387 et seq.) and grants FDA authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health generally and to reduce tobacco use by minors. FDA expects that tobacco product manufacturers will undertake tobacco product research as part of activities regulated under the Tobacco Control Act, including submission of applications for marketing orders under sections 910 and 911 of the FD&C Act. Section 911 of the FD&C Act requires FDA to issue regulations or guidance (or any combination thereof) on the scientific evidence required for assessment and ongoing review of modified risk tobacco products (MRTPs). Section 911(l)(2) requires that such regulations or guidance be developed in consultation with the Institute of Medicine (IOM), among others, on the design and conduct of such studies and surveillance. Pursuant to this requirement, the IOM convened a multidisciplinary committee and published a report in December 2011. In the report, entitled ‘‘Scientific Standards for Studies on Modified Risk Tobacco Products’’ (http:// www.iom.edu/Reports/2011/ScientificStandards-for-Studies-on-ModifiedRisk-Tobacco-Products.aspx), the IOM notes that ‘‘governance of research is critical to the production of credible and reliable evidence.’’ Specifically, the IOM report states ‘‘[t]here is profound distrust of the tobacco industry and of research supported by the tobacco industry. This distrust is the direct result of the tobacco industry’s history of improperly influencing or manipulating scientific findings and messaging about the health E:\FR\FM\02APN1.SGM 02APN1

Agencies

[Federal Register Volume 78, Number 63 (Tuesday, April 2, 2013)]
[Notices]
[Pages 19711-19713]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-07593]


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

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's (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 
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 May 2, 2013. The request should include a 
description of your facility relative to product areas CDRH regulates. 
Please include the Area of Interest/Medical Device or Technology 
(identified in table 1or 2) that the visit will demonstrate to CDRH 
staff.

ADDRESSES: Submit either electronic requests to http://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 will fully implement the 
program 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 safe, effective, high-quality 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 regulatory review staff and other staff involved in 
the premarket review process. CDRH is driven to advance regulatory 
science; provide industry with predictable, consistent, transparent, 
and efficient regulatory pathways; and assure consumer

[[Page 19712]]

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. This request includes 
those that have previously participated in the ELP or other FDA Site 
Visit programs, as well as 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
------------------------------------------------------------------------
Performance validation and             Ventilators, continuous positive
 reliability testing of intensive       airway pressure devices,
 care unit ventilator and anesthesia    anesthesia gas machines, and
 gas machines.                          closed-loop ventilators.
Implantation techniques for spinal     Implantation training and
 devices.                               assessment using cadavers and
                                        direct observation of surgical
                                        procedures for spinal implants
                                        including, but not limited to,
                                        lateral intervertebral body
                                        fusion devices, minimally
                                        invasive pedicle screw systems,
                                        and spinous process plates.
Manufacturing of ultra-high molecular  All joint replacement devices.
 weight polyethylene device
 components.
Clinical use of orthopedic bone void   Observation of surgical
 filler devices.                        procedures (posterolateral spine
                                        fusion, foot, ankle) utilizing
                                        bone void fillers.
Reprocessing methods and techniques    Cleaning and sterilization
 in the clinical environment.           methods and techniques for
                                        endoscopes (including
                                        colonoscopes, duodenoscopes,
                                        cystoscopes, etc.) and
                                        accessories; automatic endoscope
                                        reprocessors.
Bariatric surgery....................  Observation of bariatric surgical
                                        techniques, with and without
                                        bariatric devices.
Manufacturing and assessment of        Hemodialyzers, hemofilters,
 hemodialyzers and filters.             hemoconcentrators, ultrafilters,
                                        and plasma filters.
Sourcing and manufacturing of animal-  Surgical meshes, wound dressings.
 derived collagen.
Traumatic wound care, management, and  Observation of clinical uses of
 treatment.                             wound management/treatment
                                        devices and hemostatic products
                                        for use on traumatic injuries.
Clinical use of plastic and            Observation of surgical
 reconstructive devices.                procedures utilizing surgical
                                        meshes, dermal fillers,
                                        hemostatic agents, and bone
                                        waxes.
Treatment of acute ischemic stroke...  Clot retrieval procedures, clot
                                        retrieval devices and ancillary
                                        products (medications,
                                        angiograms), stroke centers, and
                                        acute stroke care programs.
Clinical use of neurosurgical          Neuro-evoked response devices
 monitoring devices.                    that are used for real-time
                                        monitoring of patients
                                        undergoing a back procedure.
Clinical use of rehabilitation         Clinical use of physical medicine
 devices.                               devices (prostheses, pressure-
                                        relieving seat cushions, tilt-in-
                                        space wheelchairs, and devices
                                        for pain relief) in a
                                        rehabilitation center setting
                                        for treatment of various
                                        conditions (e.g., spinal cord
                                        injuries, traumatic brain
                                        injuries, and amputations).
Clinical use of cardiovascular         Endovascular stent grafts and
 devices.                               associated delivery systems;
                                        Stents and associated delivery
                                        systems.
Manufacturing of cardiovascular        Drug coated devices (e.g., stents
 devices.                               and balloons), endovascular
                                        stent grafts and associated
                                        delivery systems, stents and
                                        associated delivery systems,
                                        percutaneous heart valves.
Animal testing for chronic care        Observation of surgical
 cardiovascular devices.                procedures and chronic care
                                        maintenance in animal models
                                        using chronic care
                                        cardiovascular devices, such as
                                        heart valves and ventricular
                                        assist devices.
Manufacturing of contact lenses and    All contact lenses and care
 care products.                         products.
Treatment of severe hearing loss.....  Surgical implantation of cochlear
                                        implants, electro-acoustic
                                        stimulation using hybrid
                                        cochlear implants, preservation
                                        of residual hearing,
                                        postoperative evaluation of
                                        residual hearing and implant
                                        performance.
Auditory brainstem implants (ABIs)...  Observation of ABI surgical
                                        procedures.
Management of clinical trials for      Understanding clinical trial
 medical devices.                       infrastructure, roles/
                                        responsibilities of your
                                        organization, and relationships
                                        with other organizations
                                        involved in the management and
                                        conduct of clinical trials;
                                        institutional review boards;
                                        clinical research organizations.
------------------------------------------------------------------------


   Table 2--Areas of Interest--In Vitro Diagnostic Devices/Technology
------------------------------------------------------------------------
              Focus area                   Specific areas of interest
------------------------------------------------------------------------
Manufacturing and development of       Molecular diagnostics devices,
 molecular/immunology devices.          and companion diagnostics
                                        devices.
Manufacturing, development, and        Semiautomated cytology screening
 assessment of cytology/pathology       devices; cytology collection
 devices.                               devices use in human
                                        papillomavirus tests;
                                        immunohistochemistry tests
                                        development in clinical trials.
Manufacturing of microbiology devices  Antimicrobial susceptibility
                                        devices.

[[Page 19713]]

 
Manufacturing of chemistry devices...  Clinical Laboratory Improvement
                                        Amendments (CLIA) waived
                                        devices, blood collection tubes,
                                        fecal occult blood devices.
Manufacturing and development of       Hematology analyzers (specific
 hematology devices.                    interest in new technology).
Manufacturing and development of       Coagulation assays and controls,
 coagulation devices.                   platelet aggregatometers
                                        devices, prothrombin time/
                                        international normalized ratio
                                        meters and assays, D-Dimer
                                        analyzers and assays.
Observation of clinical testing in a   Observation of testing in a
 CLIA high complexity laboratory.       clinical testing environment.
------------------------------------------------------------------------

B. Site Selection

    CDRH will be responsible for all travel expenses associated with 
the site visits. Therefore, selection of potential facilities will be 
based on the coordination of CDRH's priorities for staff training and 
the resources available for 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 are 
available for public examination in the Division of Dockets Management 
(see ADDRESSES) between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 28, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07593 Filed 4-1-13; 8:45 am]
BILLING CODE 4160-01-P