[Federal Register Volume 83, Number 146 (Monday, July 30, 2018)]
[Notices]
[Pages 36608-36609]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-16177]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-2605]


Center for Devices and Radiological Health: Experiential Learning 
Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration's (FDA) Center for Devices 
and Radiological Health (CDRH or Center) is announcing the 2019 
Experiential Learning Program (ELP). This training is intended to 
provide CDRH and other FDA staff with an opportunity to understand 
laboratory practices, quality system management, patient perspective/
input, and challenges that impact the medical device development life 
cycle. The purpose of this document is to invite medical device 
industry, academia, and health care facilities, and others to 
participate in this formal training program for CDRH and other FDA 
staff, or to contact CDRH for more information regarding the ELP.

DATES: Submit electronic proposals for participation in the ELP at 
<a href="/cdn-cgi/l/email-protection#5d18110d1d3b393c7335352e733a322b"><span class="__cf_email__" data-cfemail="b1f4fde1f1d7d5d09fd9d9c29fd6dec7">[email protected]</span></a> within the dates provided at the ELP website at https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
    <bullet> Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
    <bullet> If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'' or 
submit electronic proposals to <a href="/cdn-cgi/l/email-protection#06434a5646606267286e6e7528616970"><span class="__cf_email__" data-cfemail="f2b7bea2b2949693dc9a9a81dc959d84">[email protected]</span></a>).

Written/Paper Submissions

    Submit written/paper submissions as follows:
    <bullet> Mail/Hand delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    <bullet> For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All comments received must include the Docket No. 
FDA-2018-N-2605 for ``Center for Devices and Radiological Health: 
Experiential Learning Program.'' Received comments will be placed in 
the docket and are publicly viewable at https://www.regulations.gov or 
at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday 
through Friday.
    <bullet> Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your requests only as a written/paper submission, or 
submit electronically to <a href="/cdn-cgi/l/email-protection#d1949d8191b7b5b0ffb9b9a2ffb6bea7"><span class="__cf_email__" data-cfemail="1b5e574b5b7d7f7a35737368357c746d">[email protected]</span></a>. You should submit two copies 
total. One copy will include the information you claim to be 
confidential with a heading or cover note that states ``THIS DOCUMENT 
CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will review this copy, 
including the claimed confidential information, in its consideration of 
requests. The second copy, which will have the claimed confidential 
information redacted/blacked out, will be available for public viewing 
and posted on https://www.regulations.gov. Submit both copies to the 
Dockets Management Staff. If you do not wish your name and contact 
information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your requests and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of requests to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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

[[Page 36609]]

and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Christian Hussong, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 32, Rm. 3283, Silver Spring, MD 20993-0002, 240-
402-2246, or ELP Management, <a href="/cdn-cgi/l/email-protection#793c3529391f1d185711110a571e160f"><span class="__cf_email__" data-cfemail="5e1b120e1e383a3f7036362d70393128">[email protected]</span></a>.

SUPPLEMENTARY INFORMATION: 

I. Background

    CDRH is responsible for ensuring the safety and effectiveness of 
medical devices marketed in the United States. Additionally, CDRH 
assures patients and providers have timely and continued access to 
high-quality, safe and effective medical devices. Continuing our 2016 
and 2017 priorities of Partnering with Patients and Promoting a Culture 
of Quality and Organizational Excellence, adding our 2018-2020 
Strategic Priorities of Simplicity, Collaborative Communities and 
Employee Engagement, Opportunity, and Success, overlaid by our constant 
strive for patient safety and innovation highlights our need to 
understand the perspective of our stakeholders. The Center encourages 
applicants to consider including opportunities to discuss innovation, 
patient perspective, patient safety, incorporating quality system 
design and management, simplification principles, and utilization of 
collaborative communities in their proposal(s) as they contribute to 
the success of the device development life cycle.
    CDRH is committed to advancing regulatory science, providing 
industry with predictable, consistent, transparent, and efficient 
regulatory pathways, and helping to ensure consumer confidence in 
medical devices marketed in the United States and throughout the world. 
The ELP is intended to provide CDRH and other FDA staff with an 
opportunity to understand the laboratory and manufacturing practices, 
quality system management, patient perspective/input, simplification 
principles, and other challenges and how they impact the medical device 
development life cycle. ELP is a collaborative effort to enhance 
communication with our stakeholders to facilitate medical device 
reviews. The Center is committed to understanding current industry 
practices, innovative technologies, regulatory impacts and needs, and 
how patient perspective/input, safety and quality systems management 
advance the development and evaluation of medical devices, and 
monitoring the performance of marketed devices.
    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 and 
other FDA staff a better understanding of the products they review, and 
how they are developed. Additionally, it is to understand challenges 
related to quality systems development and management and 
simplification in processes, patient preferences and safety, in the 
product life cycle, and how medical devices fit into the larger health 
care system. CDRH is formally requesting participation from industry, 
academia, and clinical facilities, medical device incubators and 
accelerators, health technology assessment groups, and those that have 
previously participated in the ELP or other FDA site visit programs.
    Additional information regarding the CDRH ELP, including current 
areas of interest, submission dates, a sample site visit request, and 
an example of a site visit agenda, is available on CDRH's website at: 
https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

II. CDRH ELP

A. Areas of Interest

    In the ELP training program, groups of CDRH and other FDA staff 
will observe operations in the areas of research, device development, 
Digital Health, incorporating patient information and reimbursement, 
manufacturing, quality management principles, and health care 
facilities. The areas of interest for visits include various topics 
identified by managers at CDRH and other areas within FDA. These areas 
of interest are listed on the ELP website and are intended to be 
updated quarterly.
    To submit a proposal addressing one of the Center's areas of 
interest, visit the link for the table of areas of interest at: https:/
/www.fda.gov/ScienceResearch/ScienceCareerOpportunities/UCM380676.htm.
    Once you have determined an area of interest to address in your ELP 
proposal, follow the instructions in section III to complete the site 
visit request template and agenda provided at: https://www.fda.gov/downloads/ScienceResearch/ScienceCareerOpportunities/UCM392988.pdf and 
at: https://www.fda.gov/downloads/ScienceResearch/ScienceCareerOpportunities/UCM487190.pdf.
    Submit all proposals at <a href="/cdn-cgi/l/email-protection#c1848d9181a7a5a0efa9a9b2efa6aeb7"><span class="__cf_email__" data-cfemail="7d38312d3d1b191c5315150e531a120b">[email protected]</span></a> within the dates provided 
at the ELP website at: https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

B. Site Selection

    CDRH and FDA will be responsible for its own staff travel expenses 
associated with the site visits. CDRH and FDA will not provide funds to 
support the training provided by the site to the ELP. Selection of 
potential facilities will be based on CDRH and FDA'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 applicable). 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, and must be 
listed in the proposal along with a Facility Establishment Identifier 
number, if applicable.

III. Request To Participate

    Information regarding the CDRH ELP, including a sample request and 
an example of a site visit agenda, and submission dates is available on 
CDRH's website at: https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm. Proposals to participate 
should be submitted at <a href="/cdn-cgi/l/email-protection#6e2b223e2e080a0f4006061d40090118"><span class="__cf_email__" data-cfemail="eca9a0bcac8a888dc284849fc28b839a">[email protected]</span></a>, within the dates provided at 
the ELP website at: https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

    Dated: July 24, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16177 Filed 7-27-18; 8:45 am]
 BILLING CODE 4164-01-P


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