Center for Devices and Radiological Health: Experiential Learning Program, 12737-12739 [2016-05387]

Download as PDF 12737 Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of respondents Activity/21 CFR section Number of responses per respondent Average burden per response Total annual responses Total hours Waivers—812.10 .................................................................. IDE Application—812.20, 812.25, and 812.27 .................... Supplements—812.35 and 812.150 .................................... Treatment IDE Applications—812.36(c) .............................. Treatment IDE Reporting—812.36(f) ................................... 1 219 579 1 1 1 1 6 1 1 1 219 3,474 1 1 1 80 6 120 20 1 17,520 20,844 120 20 Total .............................................................................. ........................ ........................ ........................ ........................ 38,505 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1 Number of recordkeepers Activity/21 CFR section Number of records per recordkeeper Average burden per recordkeeping Total annual records Total hours Original—812.140 .............................................................. Supplemental—812.140 ..................................................... Nonsignificant—812.140 .................................................... 219 579 356 1 6 1 219 3,747 356 10 1 6 2,190 3,474 2,136 Total ............................................................................ ........................ .......................... ........................ ........................ 7,800 1 There are no capital costs or operating and maintenance costs associated with this collection of information. TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1 Activity/21 CFR section Number of respondents Number of disclosures per respondent Total annual disclosures Average burden per disclosure Total hours Reports for Nonsignificant Risk Studies—812.150 ........... 1 1 1 6 6 1 There are no capital costs or operating and maintenance costs associated with this collection of information. The estimated annual reporting burden for this extension has decreased to 38,505 hours (previously 54,253 hours) as the result of a decrease in the average number of applications and supplements submitted. For the same reason, the recordkeeping burden has decreased to 7,800 hours (previously 9,968). The previous approved total burden hours of 64,227, have therefore decreased by 17,916 to 46,311. Dated: March 4, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05385 Filed 3–9–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES mstockstill on DSK4VPTVN1PROD with NOTICES Food and Drug Administration [Docket No. FDA–2015–N–0986] Center for Devices and Radiological Health: Experiential Learning Program AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 The Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH or Center) is announcing the 2016 Experiential Learning Program (ELP). This training component is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. The purpose of this document is to invite medical device industry, academia, and health care facilities to request to participate in this formal training program for FDA’s medical device review staff, or to contact CDRH for more information regarding the ELP. DATES: Submit either an electronic or written request for participation in the ELP by April 11, 2016. 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 requests with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Christian Hussong, Center for Devices SUMMARY: PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5261, Silver Spring, MD 20993–0002, 240–402–2246, FAX: 301–827–3079, Christian.Hussong@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background CDRH is responsible for helping to ensure 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. 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. One of these initiatives, the ELP Pilot, was launched in 2012 and fully implemented on April 2, 2013 (78 FR 19711). 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 E:\FR\FM\10MRN1.SGM 10MRN1 12738 Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices and throughout the world. The ELP is intended to provide CDRH staff with an opportunity to understand the policies, laboratory practices, and challenges faced in broader disciplines that impact the device development life cycle. This component is a collaborative effort to enhance communication and facilitate the premarket review process. Furthermore, CDRH is committed to understanding current industry practices, innovative technologies, regulatory impacts, and regulatory needs. These formal training visits are not intended for FDA to inspect, assess, judge, or perform a regulatory function (e.g., compliance inspection), but rather, they are an opportunity to provide 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 or other FDA site visit programs. II. CDRH ELP A. Areas of Interest In this training program, groups of CDRH staff will observe operations at research, manufacturing, academia, and health care facilities. The focus areas and specific areas of interest for visits may include the following: TABLE 1—AREAS OF INTEREST—OFFICE OF DEVICE EVALUATION Focus area Specific areas of interest Usability testing ........................................................................................ Observe usability testing throughout a device’s life cycle and complex clinical simulations. Observe reprocessing and reuse of SUDs in a major health system (i.e. Hospital Reprocessor). Observe design, development, and testing of transcatheter heart valves, including pulmonic and aortic valve prostheses and related technology. Observe clinical EP catheter laboratory and observe catheter ablation procedures (manual and potentially robotic); including EP Lab manager and practicing EP physicians. Design, development, and testing of novel neurological medical devices qualified under early feasibility clinical trials. Design, development, and testing of neurostimulators and neuroprosthetics including BCI technologies. Observe non-clinical animal model testing demonstrating the performance of bone void fillers in the posterolateral spine. Observe the patient matched process from the surgeon’s decision to utilize patient matched technology through surgery. Design, development, and testing of ABI and observe the surgical procedure and a post-implant programming session. Design, development, and testing of contact lens care products and observe non-clinical testing for these devices. Design, development, and testing of surgical mesh indicated for gynecologic and urologic indications. Design, development, and testing of nasogastric tubes, nasojejunal tubes, and percutaneous endoscopic gastrostomy tubes. Design, development, testing, and validation of emerging RASD and mechanized laparoscopic technologies adopted from other specialties and new-area specific; and surgical simulators incorporating tissue models and force feedback mechanism or haptic technology to reduce learning curve in robotic surgery. Observe all implanted, surface contacting, and external communicating devices. Reprocessing and reuse of single-use devices (SUDs) .......................... Transcatheter heart valves ....................................................................... Cardiac electrophysiology (EP) diagnostic, mapping, and ablation devices. Neurological medical devices—early feasibility clinical trials ................... Neurostimulators and neuroprosthetics including brain-to-computer interface (BCI). Non-clinical testing—animal model .......................................................... Patient matched orthopaedic implants ..................................................... Auditory brainstem implants (ABI) ............................................................ Contact lens care products ...................................................................... Surgical mesh devices ............................................................................. Feeding tubes ........................................................................................... Robotically-assisted surgical devices (RASD) and surgical simulators in robotic surgery. Biological evaluation (i.e., biocompatibility) and viral inactivation of medical devices. TABLE 2—AREAS OF INTEREST—OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH Focus area Specific areas of interest Continuous glucose monitoring systems and insulin pumps ................... Design and development in-process, and finished device testing of continuous glucose monitoring systems and insulin pumps. Design and development in-process, and finished device testing of urine test strips and readers. Design and development in-process, and finished device testing of PT/ INR devices. Observe the detection of direct anticoagulants. Observe clinical microbiology laboratory, contract research organization (CRO), and/or industrial setting where antimicrobial susceptibility testing is being applied. Observe clinical microbiology laboratory, CRO, and/or industrial setting where NGS is being applied. Design, development, and testing of IHC reagents or digital pathology devices that are commonly used in pathology labs. Observe Clinical Laboratory Improvement Amendments labs involved with cfDNA, ctDNA, or miRNA for clinical diagnostics. Observe radiological imaging equipment (e.g. CT, MR, PET, fluoroscopy, etc.) testing and evaluation of particular consensus standards. Urine test strips and readers .................................................................... Prothrombin (PT)/international normalized ratio (INR) devices ............... mstockstill on DSK4VPTVN1PROD with NOTICES Direct anticoagulants (detection) .............................................................. Antimicrobial susceptibility testing (phenotypic, biochemical, and molecular detection). Next generation sequencing (NGS) ......................................................... Immunohistochemistry (IHC) reagents or digital pathology devices ........ Cell-free DNA/RNA biomarker technology ............................................... Radiological imaging equipment testing ................................................... VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 PO 00000 Frm 00059 Fmt 4703 Sfmt 4703 E:\FR\FM\10MRN1.SGM 10MRN1 Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices 12739 TABLE 2—AREAS OF INTEREST—OFFICE OF IN VITRO DIAGNOSTICS AND RADIOLOGICAL HEALTH—Continued Focus area Specific areas of interest Radiation therapy equipment ................................................................... Observe radiation therapy equipment (e.g., linear accelerator, proton beam therapy, brachytherapy) testing and evaluation. B. Site Selection CDRH will be responsible for CDRH staff travel expenses associated with the site visits. CDRH will not provide funds to support the training provided by the site to the ELP. 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 with the site, that firm must agree to participate in the ELP and must also have a satisfactory compliance history. mstockstill on DSK4VPTVN1PROD with NOTICES III. Request To Participate Submit 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. The request should include a description of your facility relative to focus areas described in table 1 or 2. 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(s), length of site visit, proposed dates, and maximum number of CDRH staff that can be accommodated during a site visit. Requests submitted without this minimum information will not be considered. Additional information regarding the CDRH ELP, including a sample request and an example of the site visit agenda, is available on CDRH’s Web site at: http://www.fda.gov/scienceresearch/ sciencecareeropportunities/ ucm380676.htm. Dated: March 4, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–05387 Filed 3–9–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2012–N–0976] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Guidance: Emergency Use Authorization of Medical Products AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 11, 2016. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202–395–7285, or emailed to oira_ submission@omb.eop.gov. All comments should be identified with the OMB control number 0910–0595. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE–14526, Silver Spring, MD 20993–0002, PRAStaff@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. SUMMARY: Emergency Use Authorization of Medical Products and Related Authorities; Guidance for Industry and Public Health Stakeholders OMB Control Number 0910–0595–Extension The guidance describes the Agency’s general recommendations and procedures for issuance of emergency PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 use authorizations (EUA) under section 564 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360bbb–3), which was amended by the Project BioShield Act of 2004 (Pub. L. 108–276). The FD&C Act permits the Commissioner to authorize the use of unapproved medical products or unapproved uses of approved medical products during an emergency declared under section 564 of the FD&C Act. The data to support issuance of an EUA must demonstrate that, based on the totality of the scientific evidence available to the Commissioner, including data from adequate and wellcontrolled clinical trials (if available), it is reasonable to believe that the product may be effective in diagnosing, treating, or preventing a serious or lifethreatening disease or condition (21 U.S.C. 360bbb–3(c)). Although the exact type and amount of data needed to support an EUA may vary depending on the nature of the declared emergency and the nature of the candidate product, FDA recommends that a request for consideration for an EUA include scientific evidence evaluating the product’s safety and effectiveness, including the adverse event profile for diagnosis, treatment, or prevention of the serious or life-threatening disease or condition, as well as data and other information on safety, effectiveness, risks and benefits, and (to the extent available) alternatives. Under section 564 of the FD&C Act, the FDA Commissioner may establish conditions on the authorization. Section 564(e) requires the FDA Commissioner (to the extent practicable given the circumstances of the emergency) to establish certain conditions on an authorization that the Commissioner finds necessary or appropriate to protect the public health and permits the FDA Commissioner to establish other conditions that she finds necessary or appropriate to protect the public health. Conditions authorized by section 564(e) of the FD&C Act include, for example: Requirements for information dissemination to health care providers or authorized dispensers and product recipients; adverse event monitoring and reporting; data collection and analysis; recordkeeping and records access; restrictions on product advertising, distribution, and E:\FR\FM\10MRN1.SGM 10MRN1

Agencies

[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)]
[Notices]
[Pages 12737-12739]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-05387]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0986]


Center for Devices and Radiological Health: Experiential Learning 
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration's (FDA) Center for Devices 
and Radiological Health (CDRH or Center) is announcing the 2016 
Experiential Learning Program (ELP). This training component is 
intended to provide CDRH staff with an opportunity to understand the 
policies, laboratory practices, and challenges faced in broader 
disciplines that impact the device development life cycle. The purpose 
of this document is to invite medical device industry, academia, and 
health care facilities to request to participate in this formal 
training program for FDA's medical device review staff, or to contact 
CDRH for more information regarding the ELP.

DATES: Submit either an electronic or written request for participation 
in the ELP by April 11, 2016.

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 requests with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Christian Hussong, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 5261, Silver Spring, MD 20993-0002, 240-
402-2246, FAX: 301-827-3079, Christian.Hussong@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    CDRH is responsible for helping to ensure 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. 
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. One of these 
initiatives, the ELP Pilot, was launched in 2012 and fully implemented 
on April 2, 2013 (78 FR 19711).
    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

[[Page 12738]]

and throughout the world. The ELP is intended to provide CDRH staff 
with an opportunity to understand the policies, laboratory practices, 
and challenges faced in broader disciplines that impact the device 
development life cycle. This component is a collaborative effort to 
enhance communication and facilitate the premarket review process. 
Furthermore, CDRH is committed to understanding current industry 
practices, innovative technologies, regulatory impacts, and regulatory 
needs.
    These formal training visits are not intended for FDA to inspect, 
assess, judge, or perform a regulatory function (e.g., compliance 
inspection), but rather, they are an opportunity to provide 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 or other FDA site visit programs.

II. CDRH ELP

A. Areas of Interest

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

         Table 1--Areas of Interest--Office of Device Evaluation
------------------------------------------------------------------------
               Focus area                   Specific areas of interest
------------------------------------------------------------------------
Usability testing......................  Observe usability testing
                                          throughout a device's life
                                          cycle and complex clinical
                                          simulations.
Reprocessing and reuse of single-use     Observe reprocessing and reuse
 devices (SUDs).                          of SUDs in a major health
                                          system (i.e. Hospital
                                          Reprocessor).
Transcatheter heart valves.............  Observe design, development,
                                          and testing of transcatheter
                                          heart valves, including
                                          pulmonic and aortic valve
                                          prostheses and related
                                          technology.
Cardiac electrophysiology (EP)           Observe clinical EP catheter
 diagnostic, mapping, and ablation        laboratory and observe
 devices.                                 catheter ablation procedures
                                          (manual and potentially
                                          robotic); including EP Lab
                                          manager and practicing EP
                                          physicians.
Neurological medical devices--early      Design, development, and
 feasibility clinical trials.             testing of novel neurological
                                          medical devices qualified
                                          under early feasibility
                                          clinical trials.
Neurostimulators and neuroprosthetics    Design, development, and
 including brain-to-computer interface    testing of neurostimulators
 (BCI).                                   and neuroprosthetics including
                                          BCI technologies.
Non-clinical testing--animal model.....  Observe non-clinical animal
                                          model testing demonstrating
                                          the performance of bone void
                                          fillers in the posterolateral
                                          spine.
Patient matched orthopaedic implants...  Observe the patient matched
                                          process from the surgeon's
                                          decision to utilize patient
                                          matched technology through
                                          surgery.
Auditory brainstem implants (ABI)......  Design, development, and
                                          testing of ABI and observe the
                                          surgical procedure and a post-
                                          implant programming session.
Contact lens care products.............  Design, development, and
                                          testing of contact lens care
                                          products and observe non-
                                          clinical testing for these
                                          devices.
Surgical mesh devices..................  Design, development, and
                                          testing of surgical mesh
                                          indicated for gynecologic and
                                          urologic indications.
Feeding tubes..........................  Design, development, and
                                          testing of nasogastric tubes,
                                          nasojejunal tubes, and
                                          percutaneous endoscopic
                                          gastrostomy tubes.
Robotically-assisted surgical devices    Design, development, testing,
 (RASD) and surgical simulators in        and validation of emerging
 robotic surgery.                         RASD and mechanized
                                          laparoscopic technologies
                                          adopted from other specialties
                                          and new-area specific; and
                                          surgical simulators
                                          incorporating tissue models
                                          and force feedback mechanism
                                          or haptic technology to reduce
                                          learning curve in robotic
                                          surgery.
Biological evaluation (i.e.,             Observe all implanted, surface
 biocompatibility) and viral              contacting, and external
 inactivation of medical devices.         communicating devices.
------------------------------------------------------------------------


     Table 2--Areas of Interest--Office of In Vitro Diagnostics and
                           Radiological Health
------------------------------------------------------------------------
               Focus area                   Specific areas of interest
------------------------------------------------------------------------
Continuous glucose monitoring systems    Design and development in-
 and insulin pumps.                       process, and finished device
                                          testing of continuous glucose
                                          monitoring systems and insulin
                                          pumps.
Urine test strips and readers..........  Design and development in-
                                          process, and finished device
                                          testing of urine test strips
                                          and readers.
Prothrombin (PT)/international           Design and development in-
 normalized ratio (INR) devices.          process, and finished device
                                          testing of PT/INR devices.
Direct anticoagulants (detection)......  Observe the detection of direct
                                          anticoagulants.
Antimicrobial susceptibility testing     Observe clinical microbiology
 (phenotypic, biochemical, and            laboratory, contract research
 molecular detection).                    organization (CRO), and/or
                                          industrial setting where
                                          antimicrobial susceptibility
                                          testing is being applied.
Next generation sequencing (NGS).......  Observe clinical microbiology
                                          laboratory, CRO, and/or
                                          industrial setting where NGS
                                          is being applied.
Immunohistochemistry (IHC) reagents or   Design, development, and
 digital pathology devices.               testing of IHC reagents or
                                          digital pathology devices that
                                          are commonly used in pathology
                                          labs.
Cell-free DNA/RNA biomarker technology.  Observe Clinical Laboratory
                                          Improvement Amendments labs
                                          involved with cfDNA, ctDNA, or
                                          miRNA for clinical
                                          diagnostics.
Radiological imaging equipment testing.  Observe radiological imaging
                                          equipment (e.g. CT, MR, PET,
                                          fluoroscopy, etc.) testing and
                                          evaluation of particular
                                          consensus standards.

[[Page 12739]]

 
Radiation therapy equipment............  Observe radiation therapy
                                          equipment (e.g., linear
                                          accelerator, proton beam
                                          therapy, brachytherapy)
                                          testing and evaluation.
------------------------------------------------------------------------

B. Site Selection

    CDRH will be responsible for CDRH staff travel expenses associated 
with the site visits. CDRH will not provide funds to support the 
training provided by the site to the ELP. 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 with the site, that firm must 
agree to participate in the ELP and must also have a satisfactory 
compliance history.

III. Request To Participate

    Submit 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.
    The request should include a description of your facility relative 
to focus areas described in table 1 or 2. 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(s), length of site 
visit, proposed dates, and maximum number of CDRH staff that can be 
accommodated during a site visit. Requests submitted without this 
minimum information will not be considered.
    Additional information regarding the CDRH ELP, including a sample 
request and an example of the site visit agenda, is available on CDRH's 
Web site at: http://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

    Dated: March 4, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-05387 Filed 3-9-16; 8:45 am]
 BILLING CODE 4164-01-P