Center for Devices and Radiological Health: Experiential Learning Program, 48515-48516 [2017-22626]
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Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices
Individuals or Households; Number of
Respondents: 2,200,000; Total Annual
Responses: 2,200,000; Total Annual
Hours: 550,000. (For policy questions
regarding this collection contact Sam
Jenkins at 410–786–3261.)
Dated: October 13, 2017.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2017–22630 Filed 10–17–17; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Administration for Children and
Families
[OMB No.: 0970–0426]
Submission for OMB Review;
Comment Request; Child and Family
Services Plan (CFSP), Annual Progress
and Services Review (APSR), and
Annual Budget Expenses Request and
Estimated Expenditures (CFS–101)
Description: Under title IV–B,
subparts 1 and 2, of the Social Security
Act (the Act), States, Territories, and
Tribes are required to submit a Child
and Family Services Plan (CFSP). The
CFSP lays the groundwork for a system
of coordinated, integrated, and
culturally relevant family services for
the subsequent five years (45 CFR
1357.15(a)(1)). The CFSP outlines
initiatives and activities the State,
Territory, and Tribes will carry out in
administering programs and services to
promote the safety, permanency, and
well-being of children and families,
including, as applicable, those activities
conducted under the John H. Chafee
Foster Care Independence Program
(Section 477 of the Act) and the State
grant authorized by the Child Abuse
Prevention and Treatment Act. By June
30 of each year, States, Territories, and
Tribes are also required to submit an
Annual Progress and Services Report
(APSR) and a financial report called the
CFS–101. The APSR is a yearly report
that discusses progress made by a State,
Territory or Tribe in accomplishing the
goals and objectives cited in its CFSP
(45 CFR 1357.16(a)). The APSR contains
new and updated information about
service needs and organizational
48515
capacities throughout the five-year plan
period. The CFS–101 has three parts.
Part I is an annual budget request for the
upcoming fiscal year. Part II includes a
summary of planned expenditures by
program area for the upcoming fiscal
year, the estimated number of
individuals or families to be served, and
the geographical service area. Part III
includes actual expenditures by
program area, numbers of families and
individuals served by program area, and
the geographic areas served for the last
complete fiscal year.
Respondents: States, Territories, and
Tribes must complete the CFSP, APSR,
and CFS–101. States and Territories
must also report data annually on
caseworker visits with children in foster
care. Tribes are exempted from the
caseworker visits reporting requirement
of the CFSP/APSR. There are
approximately 189 Tribal entities that
currently receive IV–B funding. There
are 53 States (including Puerto Rico, the
District of Columbia, and the U.S. Virgin
Islands) that must complete the CFSP,
APSR, and CFS–101. There are a total of
242 possible respondents.
ANNUAL BURDEN ESTIMATES
Number of
respondents
Instrument
ethrower on DSK3G9T082PROD with NOTICES
APSR ...............................................................................................................
CFSP ...............................................................................................................
CFS–101, Parts I, II, and III ............................................................................
Caseworker Visits ............................................................................................
Estimated Total Annual Burden
Hours: 31,654.59.
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research and Evaluation, 330
C Street SW., Washington, DC 20201,
Attn: Reports Clearance Officer. All
requests should be identified by the title
of the information collection. Email
address: infocollection@acf.hhs.gov.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Email: OIRA_
VerDate Sep<11>2014
17:50 Oct 17, 2017
Jkt 244001
242
48.4
242
53
SUBMISSION@OMB.EOP.GOV, Attn:
Desk Officer for the Administration for
Children and Families.
Mary Jones,
ACF/OPRE Certifying Officer.
[FR Doc. 2017–22519 Filed 10–17–17; 8:45 am]
BILLING CODE 4184–25–P
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.
The Food and Drug
Administration’s (FDA) Center for
Devices and Radiological Health (CDRH
SUMMARY:
PO 00000
Frm 00040
Fmt 4703
Sfmt 4703
Number of
responses per
respondent
1
1
1
1
Average
burden hours
per response
80
120.25
5
99.33
Total burden
hours
19,360
5,820.10
1,210
5,264.49
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.
For access to the docket to
read background documents, go to
https://www.regulations.gov and insert
ADDRESSES:
E:\FR\FM\18OCN1.SGM
18OCN1
48516
Federal Register / Vol. 82, No. 200 / Wednesday, October 18, 2017 / Notices
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,
Christian.Hussong@fda.hhs.gov or ELP
Management, ELP@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ethrower on DSK3G9T082PROD with NOTICES
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,
VerDate Sep<11>2014
17:50 Oct 17, 2017
Jkt 244001
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 ELP@
fda.hhs.gov within the dates provided at
the ELP Web site at: https://
www.fda.gov/scienceresearch/
PO 00000
Frm 00041
Fmt 4703
Sfmt 4703
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 ELP@
fda.hhs.gov, 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–5569]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Medical Devices;
Device Tracking
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
SUMMARY:
E:\FR\FM\18OCN1.SGM
18OCN1
Agencies
[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]
-----------------------------------------------------------------------
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, Christian.Hussong@fda.hhs.gov or ELP Management,
ELP@fda.hhs.gov.
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 ELP@fda.hhs.gov 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 ELP@fda.hhs.gov, 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