Program for Parallel Review of Medical Devices, 73113-73115 [2016-25659]
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73113
Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices
information collection plan is designed
to allow CDC to conduct formative
research information collection
activities for developing new tools and
methodologies to support agency
research, surveillance, program
evaluation, communications, health
promotion, and research project
development. It helps researchers
identify and understand the
characteristics of target populations that
influence their decisions and actions.
Formative research is integral in
developing programs as well as
improving existing and ongoing
programs. Formative research looks at
the community in which a public health
intervention is planned or will be
implemented and helps the project staff
understand the interests, attributes and
needs of different populations and
persons in that community. Formative
research occurs before a program is
designed and implemented, or while a
program is being conducted.
CDC conducts formative research to
develop public-sensitive and effective
communication messages and data
collection tools. To develop
scientifically valid and appropriate
methods, interventions, and
instruments, cycles of interviews and
focus groups are designed to inform the
development of a product.
Products from these formative
research studies will be used for
prevention of illness and disease.
Findings from these studies may also be
presented as evidence to disease-
specific National Advisory Committees,
to support revisions to recommended
prevention and intervention methods, as
well as new recommendations.
Much of CDC’s health communication
takes place within campaigns that have
fairly lengthy planning periods—
timeframes that accommodate the
standard Federal process for approving
data collections. Short term qualitative
interviewing and cognitive research
techniques have previously proven
invaluable in the development process.
This request may include studies
investigating the utility and
acceptability of proposed sampling and
recruitment methods, intervention
contents and delivery, questionnaire
domains, individual questions, and
interactions with project staff or
electronic data collection equipment.
These activities will also provide
information about how respondents
answer questions and ways in which
question response bias and error can be
reduced.
This request may include the
collection of information from public
health programs to assess needs related
to initiation of a new program activity
or expansion or changes in scope or
implementation of existing program
activities to adapt them to current
needs. The information collected will be
used to advise programs and provide
capacity-building assistance tailored to
the identified needs.
Overall, these development activities
are intended to provide information that
Form name
General public and health care providers.
Total response
burden (Hrs.)
1
15/60
1,250
5,000
5,000
5,000
Interview ...........................................
Focus Group Interview .....................
Survey ..............................................
[FR Doc. 2016–25601 Filed 10–21–16; 8:45 am]
Average hours
per response
5,000
Screener ...........................................
Leroy A. Richardson,
Chief, Information Collection Review Office,
Office of Scientific Integrity, Office of the
Associate Director for Science, Office of the
Director, Centers for Disease Control and
Prevention.
Number of
responses per
respondent
1
1
1
1
2
30/60
5,000
10,000
2,500
Number of
respondents
Type of respondent
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3180–N4]
Food and Drug Administration
BILLING CODE 4163–18–P
sradovich on DSK3GMQ082PROD with NOTICES
[Docket No. FDA–2010–N–0308]
Program for Parallel Review of Medical
Devices
Food and Drug Administration;
Centers for Medicare & Medicaid
Services, HHS.
ACTION: Notice.
AGENCY:
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will increase the success of surveillance
or research projects through increasing
response rates and decreasing response
error, thereby decreasing future data
collection burden to the public. The
studies that will be covered under this
request will include one or more of the
following investigational modalities: (1)
Structured and qualitative interviewing
for surveillance, research, interventions
and material development, (2) cognitive
interviewing for development of specific
data collection instruments, (3)
methodological research (4) usability
testing of technology-based instruments
and materials, (5) field testing of new
methodologies and materials, (6)
investigation of mental models for
health decision-making, to inform
health communication messages, and (7)
organizational needs assessments to
support development of capacity.
Respondents who will participate in
individual and group interviews
(qualitative, cognitive, and computer
assisted development activities) are
selected purposively from those who
respond to recruitment advertisements.
In addition to utilizing advertisements
for recruitment, respondents who will
participate in research on survey
methods may be selected purposively or
systematically from within an ongoing
surveillance or research project.
Participation of respondents is
voluntary. There is no cost to
participants other than their time.
Annual estimated burden is 18,750
hours.
The Food and Drug
Administration (FDA) and the Centers
for Medicare & Medicaid Services (CMS)
(the Agencies) are informing the public
that the Parallel Review of medical
devices pilot program will be fully
implemented and extended indefinitely.
The Agencies are soliciting nominations
from manufacturers of innovative
medical devices to participate in the
‘‘Program for Parallel Review of Medical
Devices.’’ The Parallel Review program
is a collaborative effort that is intended
to reduce the time between FDA
marketing approval or FDA’s granting of
a de novo request and Medicare
coverage decisions through CMS’s
National Coverage Determination (NCD)
SUMMARY:
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24OCN1
73114
Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices
process. This program is intended to
ensure prompt and efficient patient
access to safe and effective and
appropriate medical devices for the
Medicare population.
DATES: The program described in this
document for parallel review for
medical devices is effective October 24,
2016. The program will be fully
implemented as of the date of the
publication of this document in the
Federal Register.
FOR FURTHER INFORMATION CONTACT: For
device manufacturers interested in
Parallel Review and for general
questions: Murray Sheldon, Center for
Devices and Radiological Health, Food
and Drug Administration, 301–796–
5443, Parallel-Review@fda.hhs.gov. For
questions related to devices reviewed by
Center for Biologics Evaluation and
Research: Stephen Ripley, Center for
Biologics Evaluation and Research,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993, 240–
402–7911. For general questions about
the NCD process: Tamara Syrek Jensen,
Centers for Medicare and Medicaid
Services, 410–786–3529,
Tamara.SyrekJensen@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
sradovich on DSK3GMQ082PROD with NOTICES
I. Background
A. Parallel Review Pilot Program’s
History
As discussed in the September 17,
2010, Federal Register notice (75 FR
57045), the Agencies announced their
intention to initiate a Parallel Review
pilot program that would establish a
process for overlapping evaluation of
clinical evidence for premarket, FDAregulated medical devices in order to
reduce the time between FDA marketing
approval or FDA’s granting of a de novo
request and a Medicare NCD. The
Agencies piloted the program in an
effort to increase quality of patient
health care by facilitating earlier access
to innovative medical technologies for
Medicare beneficiaries.
In the October 11, 2011, Federal
Register notice (76 FR 62808), the
Agencies provided notice of the
procedures for voluntary participation
in the pilot program as well as the
guiding principles they intended to
follow during the program. In the
December 18, 2013, Federal Register
notice (78 FR 76628), the Agencies
extended the duration of the pilot
program for an additional 2 years.
Currently, the Agencies appreciate the
full potential of the parallel review
program and realize the positive impact
of the pilot, and have now decided to
transition into a permanent program.
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17:42 Oct 21, 2016
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B. Purpose of Parallel Review
Parallel Review allows both Agencies
to review information about a medical
device concurrently, rather than
sequentially, while continuing to make
their premarket review and coverage
decisions consistent with their
respective statutory authority. FDA
works to ensure that only safe and
effective medical devices are marketed
in the United States. CMS makes
coverage decisions for medical
technologies, which are reasonable and
necessary for the Medicare population.
Neither FDA’s premarket review criteria
nor CMS’s coverage processes criteria
change when a medical device is
accepted into the parallel review
program.
C. Lessons Learned From the Parallel
Review Pilot Program
The Agencies learned two primary
lessons from the Parallel Review pilot
program. First, they found that
manufacturers benefit from engaging
both Agencies at the pivotal clinical
trial design phase. The feedback that
manufacturers receive from both
Agencies at the pivotal clinical trial
design stage can assist manufacturers in
designing pivotal trials that can answer
both Agencies’ evidentiary questions.
Thus, it is more likely that
manufacturers will only need to
conduct a single pivotal clinical study
rather than several pivotal clinical
studies to satisfy both Agencies.
Second, concurrent review by the
Agencies of clinical evidence can
reduce the time from FDA premarket
approval or the granting of a de novo
request to an NCD. For example, on
August 11, 2014, FDA approved a
medical device that was part of the
Parallel Review Pilot Program. On the
same day, CMS initiated its national
coverage analysis (NCA). CMS
published a favorable final NCD on
October 9, 2014, less than 2 months
after the medical device received its
premarket approval and 7 months before
the NCD statutory due date.
II. Parallel Review Program
Based on the positive experience from
the Parallel Review Pilot Program, both
Agencies have decided to extend the
Parallel Review program indefinitely.
A. Parallel Review Process
The program has two stages: (1) The
pivotal clinical trial design development
stage, and (2) the concurrent evidentiary
review stage. The manufacturer should
submit a request for parallel review
prior to the start of the first stage by
sending an email to Parallel-Review@
fda.hhs.gov, which indicates their
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interest in the program and includes the
following information:
1. Nomination of manufacturer:
• Name of the manufacturer and
relevant contact information;
• name of the product;
• succinct description of the
technology and disease or condition the
device is intended to diagnose or treat;
and
• state of development of the
technology (that is, in pre-clinical
testing, in clinical trials, currently
undergoing premarket review by FDA)
2. A statement that the manufacturer
intends to meet jointly with FDA and
CMS using FDA’s Pre-Submission
program (Ref. 1), or other mechanisms
that allow for meetings of the three
parties to gather and incorporate
feedback from both Agencies about the
design and analysis of their pivotal
clinical trial, to support a marketing
application and a National Coverage
Determination.
3. A statement that the medical device
will require an original or supplemental
application for premarket approval
(PMA) or the granting of an FDA de
novo request;
4. The medical device is not excluded
by statute from Part A and/or Part B
Medicare coverage (and the request for
parallel review includes a list of Part A
and/or Part B Medicare benefit
categories, as applicable, into which the
manufacturer believes the medical
device falls); and
5. A statement that the medical device
addresses the public health needs of the
Medicare population (and the request
for parallel review includes an
explanation of how).
Upon completion of the pivotal trial
and submission of an original or
supplemental PMA, or a de novo
request, the Agencies intend to review
the pivotal clinical trial evidence
concurrently (‘‘in parallel’’). Both
Agencies will independently review the
data to determine whether it meets their
respective Agency’s standards and
communicate with the manufacturer
during their respective reviews.
Manufacturers and each Agency have
the option to withdraw from the Parallel
Review Program until CMS opens the
NCD by posting a tracking sheet. For
example, if the manufacturer would like
to withdraw from the program after the
pivotal trial, but before the NCA
tracking sheet is posted, that would be
acceptable. More information on the
NCD process is set forth in the August
7, 2013 Federal Register notice (78 FR
48164). Once a tracking sheet is posted,
CMS must complete the statutorily
defined NCD process.
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Federal Register / Vol. 81, No. 205 / Monday, October 24, 2016 / Notices
B. Candidate Prioritization
The Agencies intend to review
Parallel Review requests and respond
within 30 days after receipt of the email.
The Agencies intend to prioritize
innovative medical devices that will
benefit from the efficiencies of the
Parallel Review. Priority will also be
given to medical devices expected to
have the most impact on the Medicare
population. An FDA marketing approval
does not guarantee a favorable coverage
decision.
III. Paperwork Reduction Act of 1995
As stated in previous Federal Register
notices related to the Parallel Review
pilot, due to FDA and CMS resource
issues, the permanent program will
follow the same capacity limit by
accepting no more than five candidates
per year. As such, like the pilot
program, this collection of information
does not meet the definition of an
information collection, as defined under
44 U.S.C. 3501–3520.
IV. References
The following references are on
display in the Division of Dockets
Management (HFA–305), Food and Drug
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852, and are
available for viewing by interested
persons between 9 a.m. and 4 p.m.,
Monday through Friday; they are also
available electronically at https://
www.regulations.gov. FDA has verified
the Web site addresses, as of the date
this document publishes in the Federal
Register, but Web sites are subject to
change over time.
sradovich on DSK3GMQ082PROD with NOTICES
1. FDA Guidance, ‘‘Requests for Feedback
on Medical Device Submissions: The PreSubmission Program and Meetings with Food
and Drug Administration Staff.’’ Available at
https://www.fda.gov/downloads/
MedicalDevices/DeviceRegulationand
Guidance/GuidanceDocuments/
UCM311176.pdf.
Dated: October 18, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and
Drug Administration.
Dated: October 5, 2016.
Andy Slavitt,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2016–25659 Filed 10–21–16; 8:45 am]
BILLING CODE 4164–01–P
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Jkt 241001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0663]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Investigational
New Drug Safety Reporting
Requirements for Human Drug and
Biological Products and Safety
Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or we) is
announcing that a proposed collection
of information has been submitted to the
Office of Management and Budget
(OMB) for review and clearance under
the Paperwork Reduction Act of 1995
(the PRA).
DATES: Fax written comments on the
collection of information by November
23, 2016.
ADDRESSES: To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, FAX:
202–395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0672. Also
include the FDA docket number found
in brackets in the heading of this
document.
SUMMARY:
Investigational New Drug Safety
Reporting Requirements for Human
Drug and Biological Products and
Safety Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans; OMB Control
Number 0910–0672—Extension
In the Federal Register of October 31,
2013 (78 FR 65338), FDA published a
document entitled ‘‘Investigational New
Drug Safety Reporting Requirements for
Human Drug and Biological Products
and Safety Reporting Requirements for
Bioavailability and Bioequivalence
Studies in Humans.’’ The document
clarified the Agency’s expectations for
timely review, evaluation, and
submission of relevant and useful safety
information and implemented
internationally harmonized definitions
and reporting standards for IND safety
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73115
reports. The document also required
safety reporting for bioavailability and
bioequivalence studies. The document
was intended to improve the utility of
Investigational New Drug (IND) safety
reports, expedite FDA’s review of
critical safety information, better protect
human subjects enrolled in clinical
trials, and harmonize safety reporting
requirements internationally.
The rulemaking included the
following information collection under
the PRA that was not already included
in 21 CFR 312.32 and approved under
OMB control number 0910–0014.
Section 312.32(c)(1)(ii) and (c)(1)(iii)
requires reporting to FDA, in an IND
safety report, of potential serious risks
from clinical trials within 15 calendar
days for findings from epidemiological
studies, pooled analyses of multiple
studies, or other clinical studies that
suggest a significant risk in humans
exposed to the drug.
Section 312.32(c)(1)(iii) specifies the
requirements for reporting to FDA in an
IND safety report potential serious risks
from clinical trials within 15 calendar
days for findings from in vitro testing
that suggest a significant risk to humans.
Section 312.32(c)(1)(iv) requires
reporting to FDA in an IND safety report
within 15 calendar days of any
clinically important increase in the rate
of occurrence of serious suspected
adverse reactions over that listed in the
protocol or investigator brochure.
The rulemaking also included new
information collection under the PRA
by requiring safety reporting for
bioavailability and bioequivalence
studies (21 CFR 320.31(d)).
In tables 1 and 2 of this document, the
estimates for ‘‘No. of Respondents,’’
‘‘No. of Responses per Respondent,’’
and ‘‘Total Annual Responses’’ were
obtained from the Center for Drug
Evaluation and Research (CDER) and the
Center for Biologics Evaluation and
Research (CBER) reports and data
management systems for submissions
received in 2013, 2014, and 2015, and
from other sources familiar with the
number of submissions received under
the noted 21 CFR section. The estimates
the ‘‘Hours per Response’’ are
unchanged based on information from
CDER and CBER individuals familiar
with the burden associated with these
reports and from prior estimates
received from the pharmaceutical
industry.
In the Federal Register of March 18,
2016 (81 FR 14860), we published a 60day notice requesting public comment
on the proposed extension of this
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Agencies
[Federal Register Volume 81, Number 205 (Monday, October 24, 2016)]
[Notices]
[Pages 73113-73115]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25659]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3180-N4]
Food and Drug Administration
[Docket No. FDA-2010-N-0308]
Program for Parallel Review of Medical Devices
AGENCY: Food and Drug Administration; Centers for Medicare & Medicaid
Services, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) and the Centers for
Medicare & Medicaid Services (CMS) (the Agencies) are informing the
public that the Parallel Review of medical devices pilot program will
be fully implemented and extended indefinitely. The Agencies are
soliciting nominations from manufacturers of innovative medical devices
to participate in the ``Program for Parallel Review of Medical
Devices.'' The Parallel Review program is a collaborative effort that
is intended to reduce the time between FDA marketing approval or FDA's
granting of a de novo request and Medicare coverage decisions through
CMS's National Coverage Determination (NCD)
[[Page 73114]]
process. This program is intended to ensure prompt and efficient
patient access to safe and effective and appropriate medical devices
for the Medicare population.
DATES: The program described in this document for parallel review for
medical devices is effective October 24, 2016. The program will be
fully implemented as of the date of the publication of this document in
the Federal Register.
FOR FURTHER INFORMATION CONTACT: For device manufacturers interested in
Parallel Review and for general questions: Murray Sheldon, Center for
Devices and Radiological Health, Food and Drug Administration, 301-796-
5443, Parallel-Review@fda.hhs.gov. For questions related to devices
reviewed by Center for Biologics Evaluation and Research: Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993, 240-402-7911. For general questions about the NCD
process: Tamara Syrek Jensen, Centers for Medicare and Medicaid
Services, 410-786-3529, Tamara.SyrekJensen@cms.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
A. Parallel Review Pilot Program's History
As discussed in the September 17, 2010, Federal Register notice (75
FR 57045), the Agencies announced their intention to initiate a
Parallel Review pilot program that would establish a process for
overlapping evaluation of clinical evidence for premarket, FDA-
regulated medical devices in order to reduce the time between FDA
marketing approval or FDA's granting of a de novo request and a
Medicare NCD. The Agencies piloted the program in an effort to increase
quality of patient health care by facilitating earlier access to
innovative medical technologies for Medicare beneficiaries.
In the October 11, 2011, Federal Register notice (76 FR 62808), the
Agencies provided notice of the procedures for voluntary participation
in the pilot program as well as the guiding principles they intended to
follow during the program. In the December 18, 2013, Federal Register
notice (78 FR 76628), the Agencies extended the duration of the pilot
program for an additional 2 years.
Currently, the Agencies appreciate the full potential of the
parallel review program and realize the positive impact of the pilot,
and have now decided to transition into a permanent program.
B. Purpose of Parallel Review
Parallel Review allows both Agencies to review information about a
medical device concurrently, rather than sequentially, while continuing
to make their premarket review and coverage decisions consistent with
their respective statutory authority. FDA works to ensure that only
safe and effective medical devices are marketed in the United States.
CMS makes coverage decisions for medical technologies, which are
reasonable and necessary for the Medicare population. Neither FDA's
premarket review criteria nor CMS's coverage processes criteria change
when a medical device is accepted into the parallel review program.
C. Lessons Learned From the Parallel Review Pilot Program
The Agencies learned two primary lessons from the Parallel Review
pilot program. First, they found that manufacturers benefit from
engaging both Agencies at the pivotal clinical trial design phase. The
feedback that manufacturers receive from both Agencies at the pivotal
clinical trial design stage can assist manufacturers in designing
pivotal trials that can answer both Agencies' evidentiary questions.
Thus, it is more likely that manufacturers will only need to conduct a
single pivotal clinical study rather than several pivotal clinical
studies to satisfy both Agencies.
Second, concurrent review by the Agencies of clinical evidence can
reduce the time from FDA premarket approval or the granting of a de
novo request to an NCD. For example, on August 11, 2014, FDA approved a
medical device that was part of the Parallel Review Pilot Program. On
the same day, CMS initiated its national coverage analysis (NCA). CMS
published a favorable final NCD on October 9, 2014, less than 2 months
after the medical device received its premarket approval and 7 months
before the NCD statutory due date.
II. Parallel Review Program
Based on the positive experience from the Parallel Review Pilot
Program, both Agencies have decided to extend the Parallel Review
program indefinitely.
A. Parallel Review Process
The program has two stages: (1) The pivotal clinical trial design
development stage, and (2) the concurrent evidentiary review stage. The
manufacturer should submit a request for parallel review prior to the
start of the first stage by sending an email to Parallel-Review@fda.hhs.gov, which indicates their interest in the program and
includes the following information:
1. Nomination of manufacturer:
Name of the manufacturer and relevant contact information;
name of the product;
succinct description of the technology and disease or
condition the device is intended to diagnose or treat; and
state of development of the technology (that is, in pre-
clinical testing, in clinical trials, currently undergoing premarket
review by FDA)
2. A statement that the manufacturer intends to meet jointly with
FDA and CMS using FDA's Pre-Submission program (Ref. 1), or other
mechanisms that allow for meetings of the three parties to gather and
incorporate feedback from both Agencies about the design and analysis
of their pivotal clinical trial, to support a marketing application and
a National Coverage Determination.
3. A statement that the medical device will require an original or
supplemental application for premarket approval (PMA) or the granting
of an FDA de novo request;
4. The medical device is not excluded by statute from Part A and/or
Part B Medicare coverage (and the request for parallel review includes
a list of Part A and/or Part B Medicare benefit categories, as
applicable, into which the manufacturer believes the medical device
falls); and
5. A statement that the medical device addresses the public health
needs of the Medicare population (and the request for parallel review
includes an explanation of how).
Upon completion of the pivotal trial and submission of an original
or supplemental PMA, or a de novo request, the Agencies intend to
review the pivotal clinical trial evidence concurrently (``in
parallel''). Both Agencies will independently review the data to
determine whether it meets their respective Agency's standards and
communicate with the manufacturer during their respective reviews.
Manufacturers and each Agency have the option to withdraw from the
Parallel Review Program until CMS opens the NCD by posting a tracking
sheet. For example, if the manufacturer would like to withdraw from the
program after the pivotal trial, but before the NCA tracking sheet is
posted, that would be acceptable. More information on the NCD process
is set forth in the August 7, 2013 Federal Register notice (78 FR
48164). Once a tracking sheet is posted, CMS must complete the
statutorily defined NCD process.
[[Page 73115]]
B. Candidate Prioritization
The Agencies intend to review Parallel Review requests and respond
within 30 days after receipt of the email. The Agencies intend to
prioritize innovative medical devices that will benefit from the
efficiencies of the Parallel Review. Priority will also be given to
medical devices expected to have the most impact on the Medicare
population. An FDA marketing approval does not guarantee a favorable
coverage decision.
III. Paperwork Reduction Act of 1995
As stated in previous Federal Register notices related to the
Parallel Review pilot, due to FDA and CMS resource issues, the
permanent program will follow the same capacity limit by accepting no
more than five candidates per year. As such, like the pilot program,
this collection of information does not meet the definition of an
information collection, as defined under 44 U.S.C. 3501-3520.
IV. References
The following references are on display in the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, and are available for viewing by
interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at https://www.regulations.gov.
FDA has verified the Web site addresses, as of the date this document
publishes in the Federal Register, but Web sites are subject to change
over time.
1. FDA Guidance, ``Requests for Feedback on Medical Device
Submissions: The Pre-Submission Program and Meetings with Food and
Drug Administration Staff.'' Available at https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM311176.pdf.
Dated: October 18, 2016.
Leslie Kux,
Associate Commissioner for Policy, Food and Drug Administration.
Dated: October 5, 2016.
Andy Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2016-25659 Filed 10-21-16; 8:45 am]
BILLING CODE 4164-01-P