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