82_FR_48715 82 FR 48515 - Center for Devices and Radiological Health: Experiential Learning Program

82 FR 48515 - Center for Devices and Radiological Health: Experiential Learning Program

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 200 (October 18, 2017)

Page Range48515-48516
FR Document2017-22626

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.

Federal Register, Volume 82 Issue 200 (Wednesday, October 18, 2017)
[Federal Register Volume 82, Number 200 (Wednesday, October 18, 2017)]
[Notices]
[Pages 48515-48516]
From the Federal Register Online  [www.thefederalregister.org]
[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.

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

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, [email protected] or ELP Management, 
[email protected].

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 [email protected] 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 [email protected], 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



                                                                                   Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices                                                                48515

                                               Individuals or Households; Number of                                       Act (the Act), States, Territories, and                       capacities throughout the five-year plan
                                               Respondents: 2,200,000; Total Annual                                       Tribes are required to submit a Child                         period. The CFS–101 has three parts.
                                               Responses: 2,200,000; Total Annual                                         and Family Services Plan (CFSP). The                          Part I is an annual budget request for the
                                               Hours: 550,000. (For policy questions                                      CFSP lays the groundwork for a system                         upcoming fiscal year. Part II includes a
                                               regarding this collection contact Sam                                      of coordinated, integrated, and                               summary of planned expenditures by
                                               Jenkins at 410–786–3261.)                                                  culturally relevant family services for                       program area for the upcoming fiscal
                                                  Dated: October 13, 2017.                                                the subsequent five years (45 CFR                             year, the estimated number of
                                               William N. Parham, III,                                                    1357.15(a)(1)). The CFSP outlines                             individuals or families to be served, and
                                               Director, Paperwork Reduction Staff, Office                                initiatives and activities the State,                         the geographical service area. Part III
                                               of Strategic Operations and Regulatory                                     Territory, and Tribes will carry out in                       includes actual expenditures by
                                               Affairs.                                                                   administering programs and services to                        program area, numbers of families and
                                               [FR Doc. 2017–22630 Filed 10–17–17; 8:45 am]                               promote the safety, permanency, and                           individuals served by program area, and
                                               BILLING CODE 4120–01–P                                                     well-being of children and families,                          the geographic areas served for the last
                                                                                                                          including, as applicable, those activities                    complete fiscal year.
                                                                                                                          conducted under the John H. Chafee
                                               DEPARTMENT OF HEALTH AND                                                                                                                    Respondents: States, Territories, and
                                                                                                                          Foster Care Independence Program
                                               HUMAN SERVICES                                                                                                                           Tribes must complete the CFSP, APSR,
                                                                                                                          (Section 477 of the Act) and the State
                                                                                                                                                                                        and CFS–101. States and Territories
                                                                                                                          grant authorized by the Child Abuse
                                               Administration for Children and                                                                                                          must also report data annually on
                                                                                                                          Prevention and Treatment Act. By June
                                               Families                                                                                                                                 caseworker visits with children in foster
                                                                                                                          30 of each year, States, Territories, and
                                               [OMB No.: 0970–0426]                                                       Tribes are also required to submit an                         care. Tribes are exempted from the
                                                                                                                          Annual Progress and Services Report                           caseworker visits reporting requirement
                                               Submission for OMB Review;                                                 (APSR) and a financial report called the                      of the CFSP/APSR. There are
                                               Comment Request; Child and Family                                          CFS–101. The APSR is a yearly report                          approximately 189 Tribal entities that
                                               Services Plan (CFSP), Annual Progress                                      that discusses progress made by a State,                      currently receive IV–B funding. There
                                               and Services Review (APSR), and                                            Territory or Tribe in accomplishing the                       are 53 States (including Puerto Rico, the
                                               Annual Budget Expenses Request and                                                                                                       District of Columbia, and the U.S. Virgin
                                                                                                                          goals and objectives cited in its CFSP
                                               Estimated Expenditures (CFS–101)                                                                                                         Islands) that must complete the CFSP,
                                                                                                                          (45 CFR 1357.16(a)). The APSR contains
                                                 Description: Under title IV–B,                                           new and updated information about                             APSR, and CFS–101. There are a total of
                                               subparts 1 and 2, of the Social Security                                   service needs and organizational                              242 possible respondents.

                                                                                                                                   ANNUAL BURDEN ESTIMATES
                                                                                                                                                                                        Number of           Average
                                                                                                                                                                       Number of                                         Total burden
                                                                                                Instrument                                                                            responses per       burden hours
                                                                                                                                                                      respondents                                           hours
                                                                                                                                                                                        respondent        per response

                                               APSR ...............................................................................................................             242                1                80         19,360
                                               CFSP ...............................................................................................................            48.4                1            120.25       5,820.10
                                               CFS–101, Parts I, II, and III ............................................................................                       242                1                 5          1,210
                                               Caseworker Visits ............................................................................................                    53                1             99.33       5,264.49



                                                 Estimated Total Annual Burden                                            SUBMISSION@OMB.EOP.GOV, Attn:                                 or Center) is announcing the 2018
                                               Hours: 31,654.59.                                                          Desk Officer for the Administration for                       Experiential Learning Program (ELP).
                                                 Additional Information: Copies of the                                    Children and Families.                                        This training is intended to provide
                                               proposed collection may be obtained by                                                                                                   CDRH and other FDA staff with an
                                                                                                                          Mary Jones,
                                               writing to the Administration for                                                                                                        opportunity to understand laboratory
                                                                                                                          ACF/OPRE Certifying Officer.                                  practices, quality system management,
                                               Children and Families, Office of                                           [FR Doc. 2017–22519 Filed 10–17–17; 8:45 am]
                                               Planning, Research and Evaluation, 330                                                                                                   patient perspective/input, and
                                               C Street SW., Washington, DC 20201,
                                                                                                                          BILLING CODE 4184–25–P                                        challenges that impact the medical
                                               Attn: Reports Clearance Officer. All                                                                                                     device development life cycle. The
                                               requests should be identified by the title                                                                                               purpose of this document is to invite
                                                                                                                          DEPARTMENT OF HEALTH AND                                      medical device industry, academia, and
                                               of the information collection. Email                                       HUMAN SERVICES
                                               address: infocollection@acf.hhs.gov.                                                                                                     health care facilities, and others to
                                                                                                                          Food and Drug Administration                                  participate in this formal training
                                                 OMB Comment: OMB is required to
                                                                                                                                                                                        program for CDRH and other FDA staff,
                                               make a decision concerning the
                                                                                                                          [Docket No. FDA–2017–N–1003]                                  or to contact CDRH for more
                                               collection of information between 30
                                                                                                                                                                                        information regarding the ELP.
                                               and 60 days after publication of this
                                                                                                                          Center for Devices and Radiological                           DATES: Submit electronic proposals for
                                               document in the Federal Register.
                                                                                                                          Health: Experiential Learning Program                         participation in the ELP within the
                                               Therefore, a comment is best assured of
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                                               having its full effect if OMB receives it                                  AGENCY:        Food and Drug Administration,                  dates provided at the ELP Web site at:
                                               within 30 days of publication. Written                                     HHS.                                                          https://www.fda.gov/scienceresearch/
                                               comments and recommendations for the                                                                                                     sciencecareeropportunities/
                                                                                                                          ACTION:       Notice of availability.                         ucm380676.htm.
                                               proposed information collection should
                                               be sent directly to the following: Office                                  SUMMARY:  The Food and Drug                                   ADDRESSES:  For access to the docket to
                                               of Management and Budget, Paperwork                                        Administration’s (FDA) Center for                             read background documents, go to
                                               Reduction Project, Email: OIRA_                                            Devices and Radiological Health (CDRH                         https://www.regulations.gov and insert


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                                               48516                     Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices

                                               the docket number, found in brackets in                 judge, or perform a regulatory function               sciencecareeropportunities/
                                               the heading of this document, into the                  (e.g., compliance inspection), but rather,            ucm380676.htm.
                                               ‘‘Search’’ box and follow the prompts                   they are an opportunity to provide
                                                                                                                                                             B. Site Selection
                                               and/or go to the Dockets Management                     CDRH and other FDA staff a better
                                               Staff, 5630 Fishers Lane, Rm. 1061,                     understanding of the products they                      CDRH and FDA will be responsible
                                               Rockville, MD 20852.                                    review, how they are developed, the                   for its own staff travel expenses
                                               FOR FURTHER INFORMATION CONTACT:                        voice of the patient, challenges related              associated with the site visits. CDRH
                                               Christian Hussong, Center for Devices                   to quality systems development and                    and FDA will not provide funds to
                                               and Radiological Health, Food and Drug                  management in the product life cycle,                 support the training provided by the site
                                               Administration, 10903 New Hampshire                     and how medical devices fit into the                  to the ELP. Selection of potential
                                               Ave., Bldg. 32, Rm. 5261, Silver Spring,                larger health care system. CDRH is                    facilities will be based on CDRH and
                                               MD 20993–0002, 240–402–2246,                            formally requesting participation from                FDA’s priorities for staff training and
                                               Christian.Hussong@fda.hhs.gov or ELP                    industry, academia, and clinical                      resources available to fund this
                                               Management, ELP@fda.hhs.gov.                            facilities, medical device incubators and             program. In addition to logistical and
                                                                                                       accelerators, health technology                       other resource factors, all sites must
                                               SUPPLEMENTARY INFORMATION:
                                                                                                       assessment groups, and those that have                have a successful compliance record
                                               I. Background                                           previously participated in the ELP or                 with FDA or another Agency with
                                                                                                       other FDA site visit programs.                        which FDA has a memorandum of
                                                  CDRH is responsible for ensuring the
                                                                                                          Additional information regarding the               understanding (if applicable). If a site
                                               safety and effectiveness of medical
                                                                                                       CDRH ELP, including the table of areas                visit involves a visit to a separate
                                               devices marketed in the United States.
                                                                                                       of interest, submission dates, a sample               physical location of another firm under
                                               Additionally, CDRH assures patients
                                                                                                       request, and an example of the site visit             contract with the site, that firm must
                                               and providers have timely and
                                                                                                       agenda, is available on CDRH’s Web site               agree to participate in the ELP and must
                                               continued access to high-quality, safe,
                                                                                                       at: https://www.fda.gov/                              also have a satisfactory compliance
                                               and effective medical devices. Since
                                                                                                       scienceresearch/                                      history, and must be listed in the
                                               CDRH has identified Partnering with
                                                                                                       sciencecareeropportunities/                           proposal along with a Facility
                                               Patients and Promoting a Culture of
                                                                                                       ucm380676.htm.                                        Establishment Identifier number, if
                                               Quality and Organizational Excellence
                                                                                                                                                             applicable.
                                               as strategic priorities, for the 2018 ELP,
                                                                                                       II. CDRH ELP
                                               our goal is to specifically understand                                                                        III. Request To Participate
                                               the perspective of our stakeholders and                 A. Areas of Interest                                     Information regarding the CDRH ELP,
                                               understand implementation of these                                                                            including a sample request and an
                                               topics within their institutions. The                      In the ELP training program, groups of
                                                                                                       CDRH and other FDA staff will observe                 example of a site visit agenda, and
                                               Center encourages applicants to                                                                               submission dates is available on CDRH’s
                                               consider including opportunities to                     operations in the areas of research,
                                                                                                       device development, in making                         Web site at: https://www.fda.gov/
                                               discuss patient perspective and                                                                               scienceresearch/
                                               incorporating quality system design and                 coverage decisions and assessments,
                                                                                                       incorporating patient information and                 sciencecareeropportunities/
                                               management in their proposals as they                                                                         ucm380676.htm. Proposals to
                                               contribute to the success of the device                 reimbursement, manufacturing, and
                                                                                                       health care facilities. The areas of                  participate should be submitted to ELP@
                                               development life cycle.                                                                                       fda.hhs.gov, within the dates provided,
                                                  CDRH is committed to advancing                       interest for visits include various topics
                                                                                                       identified by managers at CDRH and                    at the ELP Web site at https://
                                               regulatory science, providing industry                                                                        www.fda.gov/scienceresearch/
                                               with predictable, consistent,                           other areas within FDA. These areas of
                                                                                                       interest are listed on the ELP Web site               sciencecareeropportunities/
                                               transparent, and efficient regulatory                                                                         ucm380676.htm.
                                               pathways, and helping to ensure                         and are intended to be updated
                                               consumer confidence in medical                          quarterly.                                              Dated: October 13, 2017.
                                               devices marketed in the United States                      To submit a proposal addressing one                Anna K. Abram,
                                               and throughout the world. The ELP is                    of the Center’s training needs, visit the             Deputy Commissioner for Policy, Planning,
                                               intended to provide CDRH and other                      link for the table of areas of interest at:           Legislation, and Analysis.
                                               FDA staff with an opportunity to                        https://www.fda.gov/ScienceResearch/                  [FR Doc. 2017–22626 Filed 10–17–17; 8:45 am]
                                               understand the laboratory and                           ScienceCareerOpportunities/                           BILLING CODE 4164–01–P
                                               manufacturing practices, quality system                 UCM380676.htm. Once you have
                                               management, patient perspective/input,                  determined an area of interest to address
                                               and other challenges and how they                       in your ELP proposal, follow the                      DEPARTMENT OF HEALTH AND
                                               impact the medical device development                   instructions in section III to complete               HUMAN SERVICES
                                               life cycle. ELP is a collaborative effort to            the site visit request template and
                                                                                                       agenda provided at: https://                          Food and Drug Administration
                                               enhance communication with our
                                               stakeholders to facilitate medical device               www.fda.gov/downloads/                                [Docket No. FDA–2017–N–5569]
                                               reviews. The Center is committed to                     ScienceResearch/
                                               understanding current industry                          ScienceCareerOpportunities/                           Agency Information Collection
                                               practices, innovative technologies,                     UCM392988.pdf and at: https://                        Activities; Proposed Collection;
                                               regulatory impacts and needs, and how                   www.fda.gov/downloads/                                Comment Request; Medical Devices;
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                                               patient perspective and quality systems                 ScienceResearch/                                      Device Tracking
                                               management advances the development                     ScienceCareerOpportunities/
                                                                                                                                                             AGENCY:    Food and Drug Administration,
                                               and evaluation of medical devices, and                  UCM487190.pdf.
                                                                                                                                                             HHS.
                                               to monitor the performance of marketed                     Submit all proposals at ELP@                       ACTION:   Notice.
                                               devices.                                                fda.hhs.gov within the dates provided at
                                                  These formal training visits are not                 the ELP Web site at: https://                         SUMMARY: The Food and Drug
                                               intended for FDA to inspect, assess,                    www.fda.gov/scienceresearch/                          Administration (FDA or Agency) is


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Document Created: 2017-10-18 01:37:58
Document Modified: 2017-10-18 01:37:58
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice of availability.
DatesSubmit 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.
ContactChristian 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, [email protected] or ELP Management, [email protected]
FR Citation82 FR 48515 

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