[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Notices]
[Pages 48515-48516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-22626]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-1003]


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 2018 
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 within 
the dates provided at the ELP Web site at: https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

ADDRESSES: For access to the docket to read background documents, go to 
https://www.regulations.gov and insert

[[Page 48516]]

the docket number, found in brackets in the heading of this document, 
into the ``Search'' box and follow the prompts and/or go to the 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. 5261, Silver Spring, MD 20993-0002, 240-
402-2246, <a href="/cdn-cgi/l/email-protection#7132190318020518101f5f390402021e1f16311715105f1919025f161e07"><span class="__cf_email__" data-cfemail="9ddef5eff4eee9f4fcf3b3d5e8eeeef2f3faddfbf9fcb3f5f5eeb3faf2eb">[email protected]</span></a> or ELP Management, 
<a href="/cdn-cgi/l/email-protection#82c7ced2c2e4e6e3aceaeaf1ace5edf4"><span class="__cf_email__" data-cfemail="084d4458486e6c692660607b266f677e">[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. Since CDRH has 
identified Partnering with Patients and Promoting a Culture of Quality 
and Organizational Excellence as strategic priorities, for the 2018 
ELP, our goal is to specifically understand the perspective of our 
stakeholders and understand implementation of these topics within their 
institutions. The Center encourages applicants to consider including 
opportunities to discuss patient perspective and incorporating quality 
system design and management in their proposals 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, 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 
and quality systems management advances the development and evaluation 
of medical devices, and to monitor 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, how 
they are developed, the voice of the patient, challenges related to 
quality systems development and management 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 the table 
of areas of interest, submission dates, 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.

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, 
in making coverage decisions and assessments, incorporating patient 
information and reimbursement, manufacturing, 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 Web site and are intended to be 
updated quarterly.
    To submit a proposal addressing one of the Center's training needs, 
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#c3868f9383a5a7a2edababb0eda4acb5"><span class="__cf_email__" data-cfemail="34717864745250551a5c5c471a535b42">[email protected]</span></a> within the dates provided 
at the ELP Web site 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 Web site at: https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm. Proposals to participate 
should be submitted to <a href="/cdn-cgi/l/email-protection#98ddd4c8d8fefcf9b6f0f0ebb6fff7ee"><span class="__cf_email__" data-cfemail="490c0519092f2d286721213a672e263f">[email protected]</span></a>, within the dates provided, at 
the ELP Web site at https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.

    Dated: October 13, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22626 Filed 10-17-17; 8:45 am]
 BILLING CODE 4164-01-P


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