81 FR 12737 - Center for Devices and Radiological Health: Experiential Learning Program
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 47 (March 10, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 47 (March 10, 2016)
| Page Range | 12737-12739 | |
| FR Document | 2016-05387 |
[Federal Register Volume 81, Number 47 (Thursday, March 10, 2016)] [Notices] [Pages 12737-12739] From the Federal Register Online [www.thefederalregister.org] [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, [email protected]. 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
![Federal Register / Vol. 81, No. 47 / Thursday, March 10, 2016 / Notices 12737
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Average
Number of Total annual
Activity/21 CFR section responses per burden per Total hours
respondents responses
respondent response
Waivers—812.10 .................................................................. 1 1 1 1 1
IDE Application—812.20, 812.25, and 812.27 .................... 219 1 219 80 17,520
Supplements—812.35 and 812.150 .................................... 579 6 3,474 6 20,844
Treatment IDE Applications—812.36(c) .............................. 1 1 1 120 120
Treatment IDE Reporting—812.36(f) ................................... 1 1 1 20 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 Average
Number of Total annual
Activity/21 CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Original—812.140 .............................................................. 219 1 219 10 2,190
Supplemental—812.140 ..................................................... 579 6 3,747 1 3,474
Nonsignificant—812.140 .................................................... 356 1 356 6 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
Number of Average
Number of Total annual
Activity/21 CFR section disclosures per burden per Total hours
respondents disclosures
respondent disclosure
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 SUMMARY: The Food and Drug and Radiological Health, Food and Drug
burden for this extension has decreased Administration’s (FDA) Center for Administration, 10903 New Hampshire
to 38,505 hours (previously 54,253 Devices and Radiological Health (CDRH Ave., Bldg. 32, Rm. 5261, Silver Spring,
hours) as the result of a decrease in the or Center) is announcing the 2016 MD 20993–0002, 240–402–2246, FAX:
average number of applications and Experiential Learning Program (ELP). 301–827–3079, Christian.Hussong@
supplements submitted. For the same This training component is intended to fda.hhs.gov.
reason, the recordkeeping burden has provide CDRH staff with an opportunity
SUPPLEMENTARY INFORMATION:
decreased to 7,800 hours (previously to understand the policies, laboratory
9,968). The previous approved total practices, and challenges faced in I. Background
burden hours of 64,227, have therefore broader disciplines that impact the CDRH is responsible for helping to
decreased by 17,916 to 46,311. device development life cycle. The ensure the safety and effectiveness of
Dated: March 4, 2016. purpose of this document is to invite medical devices marketed in the United
medical device industry, academia, and States. Furthermore, CDRH assures that
Leslie Kux,
health care facilities to request to patients and providers have timely and
Associate Commissioner for Policy.
participate in this formal training continued access to high-quality, safe,
[FR Doc. 2016–05385 Filed 3–9–16; 8:45 am] program for FDA’s medical device
BILLING CODE 4164–01–P
and effective medical devices. In
review staff, or to contact CDRH for support of this mission, the Center
more information regarding the ELP. launched various training and
DATES: Submit either an electronic or development initiatives to enhance
DEPARTMENT OF HEALTH AND
written request for participation in the performance of its staff involved in
HUMAN SERVICES
ELP by April 11, 2016. regulatory review and in the premarket
Food and Drug Administration ADDRESSES: Submit either electronic review process. One of these initiatives,
requests to http://www.regulations.gov the ELP Pilot, was launched in 2012 and
[Docket No. FDA–2015–N–0986] or written requests to the Division of fully implemented on April 2, 2013 (78
Dockets Management (HFA–305), Food
mstockstill on DSK4VPTVN1PROD with NOTICES
FR 19711).
Center for Devices and Radiological and Drug Administration, 5630 Fishers CDRH is committed to advancing
Health: Experiential Learning Program Lane, Rm. 1061, Rockville, MD 20852. regulatory science, providing industry
Identify requests with the docket with predictable, consistent,
AGENCY: Food and Drug Administration, number found in brackets in the transparent, and efficient regulatory
HHS. heading of this document. pathways, and helping to ensure
FOR FURTHER INFORMATION CONTACT: consumer confidence in medical
ACTION: Notice of availability.
Christian Hussong, Center for Devices devices marketed in the United States
VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 PO 00000 Frm 00058 Fmt 4703 Sfmt 4703 E:\FR\FM\10MRN1.SGM 10MRN1](https://thefederalregister.org/doc/81_FR_12784/page/1.svg)
![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 DEPARTMENT OF HEALTH AND use authorizations (EUA) under section
HUMAN SERVICES 564 of the Federal Food, Drug, and
CDRH will be responsible for CDRH Cosmetic Act (the FD&C Act) (21 U.S.C.
staff travel expenses associated with the Food and Drug Administration 360bbb–3), which was amended by the
site visits. CDRH will not provide funds Project BioShield Act of 2004 (Pub. L.
[Docket No. FDA–2012–N–0976]
to support the training provided by the 108–276). The FD&C Act permits the
site to the ELP. Selection of potential Agency Information Collection Commissioner to authorize the use of
facilities will be based on CDRH’s Activities; Submission for Office of unapproved medical products or
priorities for staff training and resources Management and Budget Review; unapproved uses of approved medical
available to fund this program. In Comment Request; Guidance: products during an emergency declared
addition to logistical and other resource Emergency Use Authorization of under section 564 of the FD&C Act. The
factors, all sites must have a successful Medical Products data to support issuance of an EUA
compliance record with FDA or another must demonstrate that, based on the
AGENCY: Food and Drug Administration, totality of the scientific evidence
Agency with which FDA has a
HHS. available to the Commissioner,
memorandum of understanding. If a site
ACTION: Notice. including data from adequate and well-
visit involves a visit to a separate
physical location of another firm under SUMMARY: The Food and Drug controlled clinical trials (if available), it
contract with the site, that firm must Administration (FDA) is announcing is reasonable to believe that the product
agree to participate in the ELP and must that a proposed collection of may be effective in diagnosing, treating,
also have a satisfactory compliance information has been submitted to the or preventing a serious or life-
history. Office of Management and Budget threatening disease or condition (21
(OMB) for review and clearance under U.S.C. 360bbb–3(c)). Although the exact
III. Request To Participate the Paperwork Reduction Act of 1995. type and amount of data needed to
support an EUA may vary depending on
Submit requests for participation with DATES: Fax written comments on the
the nature of the declared emergency
the docket number found in the brackets collection of information by April 11,
and the nature of the candidate product,
in the heading of this document. 2016.
FDA recommends that a request for
Received requests may be seen in the ADDRESSES: To ensure that comments on consideration for an EUA include
Division of Dockets Management (see the information collection are received, scientific evidence evaluating the
ADDRESSES) between 9 a.m. and 4 p.m., OMB recommends that written product’s safety and effectiveness,
Monday through Friday. comments be faxed to the Office of including the adverse event profile for
Information and Regulatory Affairs, diagnosis, treatment, or prevention of
The request should include a
OMB, Attn: FDA Desk Officer, FAX: the serious or life-threatening disease or
description of your facility relative to
202–395–7285, or emailed to oira_ condition, as well as data and other
focus areas described in table 1 or 2. submission@omb.eop.gov. All
Please include the Area of Interest (see information on safety, effectiveness,
comments should be identified with the risks and benefits, and (to the extent
table 1 or 2) that the site visit will OMB control number 0910–0595. Also available) alternatives.
demonstrate to CDRH staff, a contact include the FDA docket number found
person, site visit location(s), length of Under section 564 of the FD&C Act,
in brackets in the heading of this the FDA Commissioner may establish
site visit, proposed dates, and maximum document.
number of CDRH staff that can be conditions on the authorization. Section
FOR FURTHER INFORMATION CONTACT: FDA 564(e) requires the FDA Commissioner
accommodated during a site visit.
PRA Staff, Office of Operations, Food (to the extent practicable given the
Requests submitted without this and Drug Administration, 8455 circumstances of the emergency) to
minimum information will not be Colesville Rd., COLE–14526, Silver establish certain conditions on an
considered. Spring, MD 20993–0002, PRAStaff@ authorization that the Commissioner
Additional information regarding the fda.hhs.gov. finds necessary or appropriate to protect
CDRH ELP, including a sample request SUPPLEMENTARY INFORMATION: In the public health and permits the FDA
and an example of the site visit agenda, compliance with 44 U.S.C. 3507, FDA Commissioner to establish other
is available on CDRH’s Web site at: has submitted the following proposed conditions that she finds necessary or
http://www.fda.gov/scienceresearch/ collection of information to OMB for appropriate to protect the public health.
sciencecareeropportunities/ review and clearance. Conditions authorized by section 564(e)
ucm380676.htm. of the FD&C Act include, for example:
Emergency Use Authorization of
mstockstill on DSK4VPTVN1PROD with NOTICES
Dated: March 4, 2016.
Requirements for information
Medical Products and Related dissemination to health care providers
Leslie Kux, Authorities; Guidance for Industry and or authorized dispensers and product
Associate Commissioner for Policy. Public Health Stakeholders OMB recipients; adverse event monitoring
[FR Doc. 2016–05387 Filed 3–9–16; 8:45 am] Control Number 0910–0595–Extension and reporting; data collection and
BILLING CODE 4164–01–P The guidance describes the Agency’s analysis; recordkeeping and records
general recommendations and access; restrictions on product
procedures for issuance of emergency advertising, distribution, and
VerDate Sep<11>2014 17:55 Mar 09, 2016 Jkt 238001 PO 00000 Frm 00060 Fmt 4703 Sfmt 4703 E:\FR\FM\10MRN1.SGM 10MRN1](https://thefederalregister.org/doc/81_FR_12784/page/3.svg)
Document Created: 2018-02-02 15:11:47
Document Modified: 2018-02-02 15:11:47
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| Dates | Submit either an electronic or written request for participation in the ELP by April 11, 2016. | |
| 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, [email protected] | |
| FR Citation | 81 FR 12737 |
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