Center for Devices and Radiological Health: Experiential Learning Program, 14903-14904 [2017-05763]
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14903
Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices
Notice of Award of one singlesource expansion supplement grant
under the Unaccompanied Children’s
(UC) Program.
ACTION:
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
ACF, ORR, announces the
award of one single-source expansion
supplement grant for a total of
$1,768,571 under the UC Program.
SUMMARY:
[CFDA Number: 93.676]
Announcement of the Award of One
Single-Source Expansion Supplement
Grant Within the Office of Refugee
Resettlement’s Unaccompanied
Children’s Program
Office of Refugee Resettlement
(ORR), Administration for Children and
Families (ACF), U.S. Department of
Health and Human Services (HHS).
AGENCY:
Grantee
Expansion supplement grants
will support activities from February 1,
2017, through March 31, 2017.
DATES:
FOR FURTHER INFORMATION CONTACT:
Jallyn Sualog, Director, Division of
Children’s Services, Office of Refugee
Resettlement, 330 C Street SW.,
Proposed
period of
support start
date
Grant No.
Proposed
period of
support end
date
Washington, DC 20201. Email:
DCSProgram@acf.hhs.gov.
SUPPLEMENTARY INFORMATION: The
following supplement grant will support
the immediate need for additional
capacity of shelter services to
accommodate the increasing number of
UC referred by the Department of
Homeland Security (DHS) into ORR
care. The increase in the UC population
necessitates the need for expansion of
services to expedite the release of UC.
In order to be prepared for an increase
in referrals for shelter services, ORR will
solicit proposals from one grantee to
accommodate the extensive amount of
referrals from DHS.
Number of
days
Number of
shelter beds
Award amount
90ZU0119
2/1/2017
3/31/2017
59
100
$1,768,571
Total ..................................................
sradovich on DSK3GMQ082PROD with NOTICES
International Educational Services, Inc ...
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1,768,571
ORR has specific requirements for the
provision of services. Award recipients
must have the infrastructure, licensing,
experience, and appropriate level of
trained staff to meet those requirements.
The expansion of the existing shelter
services program through this
supplemental award is a key strategy for
ORR to be prepared to meet its
responsibility of safe and timely release
of UC referred to its care by DHS and
so that the U.S. Border Patrol can
continue its vital national security
mission to prevent illegal migration and
trafficking, and protect the borders of
the United States.
Statutory Authority: This program is
authorized by—
(A) Section 462 of the Homeland
Security Act of 2002, which in March
2003, transferred responsibility for the
care and custody of Unaccompanied
Alien Children from the Commissioner
of the former Immigration and
Naturalization Service (INS) to the
Director of ORR of HHS.
(B) The Flores Settlement Agreement,
Case No. CV85–4544RJK (C.D. Cal.
1996), as well as the William
Wilberforce Trafficking Victims
Protection Reauthorization Act of 2008
(Pub. L. 110–457), which authorizes
post release services under certain
conditions to eligible children. All
programs must comply with the Flores
Settlement Agreement, Case No. CV85–
4544–RJK (C.D. Cal. 1996), pertinent
VerDate Sep<11>2014
17:13 Mar 22, 2017
Jkt 241001
regulations and ORR policies and
procedures.
Elizabeth Leo,
Grants Policy Specialist, Division of Grants
Policy, Office of Administration,
Administration for Children and Families.
[FR Doc. 2017–05746 Filed 3–22–17; 8:45 am]
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
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration’s (FDA) Center for
Devices and Radiological Health (CDRH
or Center) is announcing the 2017
Experiential Learning Program (ELP).
This training component is intended to
provide CDRH staff with an opportunity
to understand the policies, laboratory
practices, patient perspective/input,
quality system management, and other
challenges that impact the 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’s employees, or to contact CDRH
for more information regarding the ELP.
SUMMARY:
PO 00000
Frm 00039
Fmt 4703
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,
Christian.Hussong@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
BILLING CODE 4184–45–P
AGENCY:
Submit either electronic or
written requests for participation in the
ELP by dates specified in the ELP Web
site at: https://www.fda.gov/
scienceresearch/
sciencecareeropportunities/
ucm380676.htm.
DATES:
Sfmt 4703
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. For
2016–2017, CDRH has identified
Partnering with Patients and Promoting
a Culture of Quality and Organizational
Excellence as strategic priorities,
specifically having the perspective of
our stakeholders and understanding
implementation of these within their
E:\FR\FM\23MRN1.SGM
23MRN1
sradovich on DSK3GMQ082PROD with NOTICES
14904
Federal Register / Vol. 82, No. 55 / Thursday, March 23, 2017 / Notices
institutions would provide great insight
to FDA review staff. The Center
encourages applicants to consider
including opportunities to discuss
patient perspective and meeting the
challenges of quality systems design and
management 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 staff with an
opportunity to understand the policies,
laboratory and manufacturing practices,
and the challenges addressing patient
perspective/input, quality system
management, and other challenges that
impact the device development life
cycle. This component is a collaborative
effort to enhance communication and
facilitate the premarket review process.
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 innovative devices,
and to 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 review 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
companies, academia, and clinical
facilities, medical device incubators and
accelerators, health insurers, health
technology assessment groups, and
others, including those that have
previously participated in the ELP or
other FDA site visit programs.
CDRH encourages applicants to
consider including opportunities to
discuss how patient perspective and
effective quality systems management
contribute to the success of the device
development life cycle. Additional
information regarding the CDRH ELP,
including the table of areas of interest,
submission dates and deadlines, a
sample request, and an example of the
site visit agenda, is available on CDRH’s
Web site at: https://www.fda.gov/
VerDate Sep<11>2014
17:13 Mar 22, 2017
Jkt 241001
scienceresearch/
sciencecareeropportunities/
ucm380676.htm. The Center encourages
applicants to consider including
opportunities to discuss patient
perspective and meeting the challenges
of Quality Systems Design and
Management as they contribute to the
success of the device development life
cycle.
II. CDRH ELP
A. Areas of Interest
In this training program, groups of
CDRH staff will observe operations in
the areas of research, device
development, in making coverage
decisions and assessments,
incorporating patient information and
reimbursement, manufacturing,
academia, and health care facilities. The
areas of interest for visits include
various topics identified by managers at
CDRH. These areas of interest are listed
publicly 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 to
be addressed 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
properly fill out 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.
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
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
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
with a Facility Establishment Identifier
number (FEI #) if applicable.
III. Request to Participate
Submit proposals 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.
Additional information regarding the
CDRH ELP, including a sample request
and an example of a site visit agenda
and submission deadlines, is available
on CDRH’s Web site at: https://
www.fda.gov/scienceresearch/
sciencecareeropportunities/
ucm380676.htm.
Dated: March 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017–05763 Filed 3–22–17; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–D–0198]
Delayed Graft Function in Kidney
Transplantation: Developing Drugs for
Prevention; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry entitled ‘‘Delayed
Graft Function in Kidney
Transplantation: Developing Drugs for
Prevention.’’ The purpose of this
guidance is to assist sponsors in the
clinical development of drugs for the
prevention of delayed graft function
(DGF) in kidney transplantation.
DATES: Although you can comment on
any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
considers your comment on this draft
guidance before it begins work on the
final version of the guidance, submit
either electronic or written comments
on the draft guidance by June 21, 2017.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
E:\FR\FM\23MRN1.SGM
23MRN1
Agencies
[Federal Register Volume 82, Number 55 (Thursday, March 23, 2017)]
[Notices]
[Pages 14903-14904]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-05763]
-----------------------------------------------------------------------
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 2017
Experiential Learning Program (ELP). This training component is
intended to provide CDRH staff with an opportunity to understand the
policies, laboratory practices, patient perspective/input, quality
system management, and other challenges that impact the 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's
employees, or to contact CDRH for more information regarding the ELP.
DATES: Submit either electronic or written requests for participation
in the ELP by dates specified in the ELP Web site at: https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.
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, 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.
For 2016-2017, CDRH has identified Partnering with Patients and
Promoting a Culture of Quality and Organizational Excellence as
strategic priorities, specifically having the perspective of our
stakeholders and understanding implementation of these within their
[[Page 14904]]
institutions would provide great insight to FDA review staff. The
Center encourages applicants to consider including opportunities to
discuss patient perspective and meeting the challenges of quality
systems design and management 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 staff with an opportunity to
understand the policies, laboratory and manufacturing practices, and
the challenges addressing patient perspective/input, quality system
management, and other challenges that impact the device development
life cycle. This component is a collaborative effort to enhance
communication and facilitate the premarket review process. 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 innovative devices, and to 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 review
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 companies, academia, and
clinical facilities, medical device incubators and accelerators, health
insurers, health technology assessment groups, and others, including
those that have previously participated in the ELP or other FDA site
visit programs.
CDRH encourages applicants to consider including opportunities to
discuss how patient perspective and effective quality systems
management contribute to the success of the device development life
cycle. Additional information regarding the CDRH ELP, including the
table of areas of interest, submission dates and deadlines, 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. The Center encourages
applicants to consider including opportunities to discuss patient
perspective and meeting the challenges of Quality Systems Design and
Management as they contribute to the success of the device development
life cycle.
II. CDRH ELP
A. Areas of Interest
In this training program, groups of CDRH staff will observe
operations in the areas of research, device development, in making
coverage decisions and assessments, incorporating patient information
and reimbursement, manufacturing, academia, and health care facilities.
The areas of interest for visits include various topics identified by
managers at CDRH. These areas of interest are listed publicly 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 to be addressed 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 properly fill out
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.
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 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 (FEI #) if
applicable.
III. Request to Participate
Submit proposals 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.
Additional information regarding the CDRH ELP, including a sample
request and an example of a site visit agenda and submission deadlines,
is available on CDRH's Web site at: https://www.fda.gov/scienceresearch/sciencecareeropportunities/ucm380676.htm.
Dated: March 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-05763 Filed 3-22-17; 8:45 am]
BILLING CODE 4164-01-P