Medical Device User Fee Amendments; Public Meeting; Request for Comments, 69829-69834 [2016-24237]
Download as PDF
<![CDATA[
mstockstill on DSK3G9T082PROD with NOTICES
Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices
physician certification requirements
were included in the law to ensure that
patients require a level of care that is
covered by the Medicare program and
because the physician is a key figure in
determining the utilization of health
services. Form Number: CMS–R–5
(OMB control number: 0938–0454);
Frequency: Occasionally; Affected
Public: Business or other for-profits and
Not-for-profit institutions; Number of
Respondents: 2,711,136; Total Annual
Responses: 2,711,136; Total Annual
Hours: 624,515. (For policy questions
regarding this collection contact Kia
Sidbury at 410–786–7816.)
3. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Medicare
Program/Home Health Prospective
Payment System Rate Update for
Calendar Year 2010: Physician Narrative
Requirement and Supporting
Regulation; Use: Section (o) of the Act
(42 U.S.C. 1395x) specifies certain
requirements that a home health agency
must meet to participate in the Medicare
program. To qualify for Medicare
coverage of home health services a
Medicare beneficiary must meet each of
the following requirements as stipulated
in § 409.42: Be confined to the home or
an institution that is not a hospital,
SNF, or nursing facility as defined in
sections 1861(e)(1), 1819(a)(1) or 1919 of
Act; be under the care of a physician as
described in § 409.42(b); be under a plan
of care that meets the requirements
specified in § 409.43; the care must be
furnished by or under arrangements
made by a participating HHA, and the
beneficiary must be in need of skilled
services as described in § 409.42(c).
Subsection 409.42(c) of our regulations
requires that the beneficiary need at
least one of the following services as
certified by a physician in accordance
with § 424.22: Intermittent skilled
nursing services and the need for skilled
services which meet the criteria in
§ 409.32; Physical therapy which meets
the requirements of § 409.44(c), Speechlanguage pathology which meets the
requirements of § 409.44(c); or have a
continuing need for occupational
therapy that meets the requirements of
§ 409.44(c), subject to the limitations
described in § 409.42(c)(4). On March
23, 2010, the Affordable Care Act of
2010 (Pub. L. 111–148) was enacted.
Section 6407(a) (amended by section
10605) of the Affordable Care Act
amends the requirements for physician
certification of home health services
contained in Sections 1814(a)(2)(C) and
1835(a)(2)(A) by requiring that, prior to
certifying a patient as eligible for
VerDate Sep<11>2014
17:36 Oct 06, 2016
Jkt 241001
Medicare’s home health benefit, the
physician must document that the
physician himself or herself or a
permitted non-physician practitioner
has had a face-to-face encounter
(including through the use of tele-health
services, subject to the requirements in
section 1834(m) of the Act)’’, with the
patient. The Affordable Care Act
provision does not amend the statutory
requirement that a physician must
certify a patient’s eligibility for
Medicare’s home health benefit, (see
Sections 1814(a)(2)(C) and 1835(a)(2)(A)
of the Act. Form Number: CMS–10311
(OMB control number: 0938–1083);
Frequency: Yearly; Affected Public:
Business or other for-profits; Number of
Respondents: 345,600; Total Annual
Responses: 345,600; Total Annual
Hours: 28,800. (For policy questions
regarding this collection contact Hillary
Loeffler at 410–786–0456.)
4. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Documentation
Requirements Concerning Emergency
and Nonemergency Ambulance
Transports Described in the Beneficiary
Signature Regulations in 42 CFR
424.36(b); Use: The statutory authority
requiring a beneficiary’s signature on a
claim submitted by a provider is located
in section 1835(a) and in 1814(a) of the
Social Security Act (the Act), for Part B
and Part A services, respectively. The
authority requiring a beneficiary’s
signature for supplier claims is implicit
in sections 1842(b)(3)(B)(ii) and in
1848(g)(4) of the Act. Federal
regulations at 42 CFR 424.32(a)(3) state
that all claims must be signed by the
beneficiary or on behalf of the
beneficiary (in accordance with 424.36).
Section 424.36(a) states that the
beneficiary’s signature is required on a
claim unless the beneficiary has died or
the provisions of 424.36(b), (c), or (d)
apply. We believe that for emergency
and nonemergency ambulance transport
services, where the beneficiary is
physically or mentally incapable of
signing the claim (and the beneficiary’s
authorized representative is unavailable
or unwilling to sign the claim), that it
is impractical and infeasible to require
an ambulance provider or supplier to
later locate the beneficiary or the person
authorized to sign on behalf of the
beneficiary, before submitting the claim
to Medicare for payment. Therefore, we
created an exception to the beneficiary
signature requirement with respect to
emergency and nonemergency
ambulance transport services, where the
beneficiary is physically or mentally
incapable of signing the claim, and if
PO 00000
Frm 00052
Fmt 4703
Sfmt 4703
69829
certain documentation requirements are
met. Thus, we added subsection (6) to
paragraph (b) of 42 CFR 424.36. The
information required in this ICR is
needed to help ensure that services were
in fact rendered and were rendered as
billed. Form Number: CMS–10242
(OMB control number: 0938–1049);
Frequency: Yearly; Affected Public:
Business or other for-profits, Not-forprofit institutions); Number of
Respondents: 10,402; Total Annual
Responses: 14,155,617; Total Annual
Hours: 1,180,578. (For policy questions
regarding this collection contact Martha
Kuespert at 410–786–4605.)
Dated: October 4, 2016.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2016–24341 Filed 10–6–16; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–N–2872]
Medical Device User Fee Amendments;
Public Meeting; Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice of public meeting;
request for comments.
ACTION:
The Food and Drug
Administration (FDA) is announcing a
public meeting entitled ‘‘Medical Device
User Fee Amendments.’’ The purpose of
the meeting is to discuss proposed
recommendations for the
reauthorization of the Medical Device
User Fee Amendments (MDUFA) for
fiscal years (FYs) 2018 through 2022.
MDUFA authorizes FDA to collect fees
and use them for the process for the
review of medical device applications.
The current legislative authority for
MDUFA expires October 1, 2017. At that
time, new legislation will be required
for FDA to continue collecting medical
device user fees in future fiscal years.
Following discussions with the device
industry and periodic consultations
with public stakeholders, the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act) directs FDA to publish the
recommendations for the reauthorized
program in the Federal Register, hold a
meeting at which the public may
present its views on such
recommendations, and provide for a
period of 30 days for the public to
provide written comments on such
recommendations. FDA will then
SUMMARY:
E:\FR\FM\07OCN1.SGM
07OCN1
69830
Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices
consider such public views and
comments and revise such
recommendations as necessary.
DATES: The public meeting will be held
on November 2, 2016, from 9 a.m. to 5
p.m. Submit electronic or written
comments to the public docket by
November 14, 2016. When the materials
are available, they will be in the docket
and posted on this Web site at: https://
www.fda.gov/ForIndustry/UserFees/
MedicalDeviceUserFee/ucm454039.htm.
See REGISTRATION section below
regarding how to register for this public
meeting.
ADDRESSES: The public meeting will be
held at FDA White Oak Campus, 10903
New Hampshire Ave., Building 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993.
Entrance for the public meeting
participants (non-FDA employees) is
through Building 1 where routine
security check procedures will be
performed. For parking and security
information, please refer to https://
www.fda.gov/AboutFDA/
WorkingatFDA/BuildingsandFacilities/
WhiteOakCampusInformation/
ucm241740.htm.
You may submit comments as
follows:
mstockstill on DSK3G9T082PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
VerDate Sep<11>2014
17:36 Oct 06, 2016
Jkt 241001
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2016–N–2872 for ‘‘Medical Device User
Fee Amendments; Public Meeting.’’ The
commitment letter and proposed
statutory changes are expected to be
made public in mid-October. At that
time, the materials will be posted in the
docket and on this Web site at: https://
www.fda.gov/ForIndustry/UserFees/
MedicalDeviceUserFee/ucm454039.htm.
The docket will close on November 14,
2016. Received comments will be
placed in the docket and, except for
those submitted as ‘‘Confidential
Submissions,’’ publicly available at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
PO 00000
Frm 00053
Fmt 4703
Sfmt 4703
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert 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 Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Aaron Josephson, Center for Devices
and Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 5449, Silver Spring,
MD 20993, 301–796–5178,
Aaron.Josephson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing its intention to
hold a public meeting to discuss
proposed recommendations for the
reauthorization of MDUFA, which
authorizes FDA to collect user fees and
use them for the process for the review
of device applications until September
30, 2017. Without new legislation, FDA
will no longer be able to collect user
fees for future fiscal years to provide
funds for the process for the review of
device applications. As required by
section 738A(b)(2), (3), and (6) of the
FD&C Act (21 U.S.C. 379j-1(b)(2), (3),
and (6)), FDA obtained prior public
input and negotiated an agreement with
regulated industry while periodically
consulting with patient and consumer
advocacy groups and making minutes of
negotiation and stakeholder meetings
publicly available. Section 738A(b)(4) of
the FD&C Act requires that, after
holding negotiations with regulated
industry and before transmitting the
Agency’s final recommendations to
Congress for the reauthorized program
(MDUFA IV), we do the following: (1)
Present the draft recommendations to
the Committee on Energy and
Commerce of the U.S. House of
Representatives and the Committee on
Health, Education, Labor, and Pensions
of the U.S. Senate; (2) publish the draft
recommendations in the Federal
Register; (3) provide a period of 30 days
for the public to submit written
comments on the draft
recommendations; (4) hold a meeting at
which the public may present its views
on the draft recommendations; and (5)
after consideration of public views and
comments, revise the draft
recommendations as necessary. This
notice, the 30-day comment period, and
the public meeting will satisfy certain of
E:\FR\FM\07OCN1.SGM
07OCN1
Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
these requirements. After the public
meeting, we will revise the draft
recommendations as necessary. In
addition, the Agency will present the
draft recommendations to the
Congressional committees.
The purpose of the meeting is for the
public to present its views on the draft
recommendations for the reauthorized
program (MDUFA IV). In general, the
meeting format will include a brief
presentation by FDA, but will focus on
hearing from different stakeholder
interest groups (such as patient
advocates, consumer advocates,
industry, health care professionals, and
scientific and academic experts). The
Agency will also provide an opportunity
for individuals to make presentations at
the meeting and for organizations and
individuals to submit written comments
to the docket before and after the
meeting. The following information is
provided to help potential meeting
participants better understand the
history and evolution of the medical
device user fee program and the current
status of the MDUFA IV draft
recommendations.
II. What is MDUFA and what does it
do?
MDUFA is the law that authorizes
FDA to collect fees from device
companies that register their
establishments, submit applications to
market devices, and make other types of
submissions. In the years preceding
enactment of the Medical Device User
Fee and Modernization Act of 2002
(MDUFMA) (Pub. L. 107–250), FDA’s
medical device program suffered a longterm, significant loss of resources that
undermined the program’s capacity and
performance. MDUFMA was enacted
‘‘in order to provide FDA with the
resources necessary to better review
medical devices, to enact needed
regulatory reforms so that medical
device manufacturers can bring their
safe and effective devices to the
American people at an earlier point in
time, and to ensure that reprocessed
medical devices are as safe and effective
as original devices.’’ H.R. Rep. 107–728
at p. 21 (Oct. 7, 2002). MDUFMA was
authorized for 5 years and contained
two important features that relate to
reauthorization:
• User fees for the review of medical
device premarket applications, reports,
supplements, and premarket
notification submissions provided
additional resources to make FDA
reviews more timely, predictable, and
transparent to applicants. User fees and
appropriations for the medical device
program helped FDA expand available
expertise, modernized its information
VerDate Sep<11>2014
17:36 Oct 06, 2016
Jkt 241001
management systems, provided new
review options, and provided more
guidance to prospective submitters. The
ultimate goal was for FDA to clear and
approve safe and effective medical
devices more rapidly, benefiting
applicants, the health care community,
and most importantly, patients.
• Negotiated performance goals for
many types of premarket reviews
provided FDA with benchmarks for
measuring review improvements. These
quantifiable goals became more
demanding each year and included FDA
decision goals and cycle goals (cycle
goals refer to FDA actions prior to a
final action on a submission). Under
MDUFMA, FDA also agreed to several
other commitments that did not have
specific timeframes or direct measures
of performance, such as expanding the
use of meetings with industry,
maintenance of current performance in
review areas where specific
performance goals had not been
identified, and publication of additional
guidance documents.
Medical device user fees and
increased appropriations were viewed
by FDA, Congress, and industry
stakeholders as essential to support
high-quality, timely medical device
reviews, and other activities critical to
the device review program.
MDUFMA provided for—and
reauthorizations have maintained—fee
discounts and waivers for qualifying
small businesses. Small businesses
make up a large proportion of the
medical device industry, and these
discounts and waivers helped reduce
the financial impact of user fees on this
sector of the device industry, which
plays an important role in fostering
innovation.
Since MDUFMA was first enacted in
2002, it has been reauthorized twice (the
2007 Medical Device User Fee
Amendments (MDUFA II) and the 2012
Medical Device User Fee Amendments
(MDUFA III)). Under MDUFA III, which
has been in effect since 2012 and will
expire on October 1, 2017, FDA has met
or exceeded nearly all submission
performance goals while implementing
program enhancements designed to
ensure more timely access to safe and
effective medical devices. Information
about FDA’s performance is available in
the yearly and quarterly MDUFA
performance reports, which are online
at: https://www.fda.gov/AboutFDA/
ReportsManualsForms/Reports/
UserFeeReports/PerformanceReports/
UCM2007450.htm and https://
www.fda.gov/ForIndustry/UserFees/
MedicalDeviceUserFee/ucm452535.htm.
User fees and related performance
goals have played an important role in
PO 00000
Frm 00054
Fmt 4703
Sfmt 4703
69831
providing resources and supporting the
management systems for ensuring that
safe and effective medical devices are
available to patients in a timely manner.
III. Proposed MDUFA IV
Recommendations
In preparing the proposed
recommendations to Congress for
MDUFA reauthorization, FDA
conducted discussions with the device
industry and consulted with
stakeholders, as required by the FD&C
Act. The Agency began the MDUFA
reauthorization process by publishing a
notice in the Federal Register
requesting public input on the
reauthorization and announcing a
public meeting that was held on July 13,
2015. The meeting included
presentations by FDA and a series of
panels with representatives of different
stakeholder groups, including patient
and consumer advocacy groups,
regulated industry, and health care
professionals. The materials from the
meeting, including a transcript and
Webcast recording, can be found at
https://www.fda.gov/MedicalDevices/
NewsEvents/WorkshopsConferences/
ucm445541.htm.
From September 2015 through August
2016, FDA conducted negotiations with
representatives of the device industry:
The Advanced Medical Technology
Association; the Medical Device
Manufacturers Association; the Medical
Imaging and Technology Alliance; and,
the American Clinical Laboratory
Association. During its negotiations
with the regulated industry, FDA also
held monthly consultations with
stakeholders representing patient and
consumer interests. As directed by
Congress, FDA posted minutes of these
meetings on its Web site at: https://
www.fda.gov/ForIndustry/UserFees/
MedicalDeviceUserFee/ucm454039.htm.
The proposed recommendations for
MDUFA IV address many priorities
identified by public stakeholders, the
device industry, and FDA. While some
of the proposed recommendations are
new, many either build on successful
enhancements or refine elements from
the existing program. FDA intends to
post the full text of the proposed
MDUFA IV commitment letter and
proposed statutory changes at: https://
www.fda.gov/ForIndustry/UserFees/
MedicalDeviceUserFee/ucm454039.htm
before the public meeting. Each
recommendation is briefly described
with reference to the applicable section
of the draft commitment letter.
A. Shared Outcome Goals
FDA and representatives of the device
industry believe that the process
E:\FR\FM\07OCN1.SGM
07OCN1
69832
Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices
improvements outlined in the draft
commitment letter, when implemented
by all parties as intended, should
further reduce the average Total Time to
Decision for PMA applications and
510(k) submissions, provided that the
total funding of the device review
program adheres to the assumptions
underlying the agreement. Reducing
average Total Time to Decision is an
important aspect of the ultimate goal of
the user fee program, so that safe and
effective devices reach patients and
health care professionals more quickly.
FDA will continue reporting, on an
annual basis, the average Total Time to
Decision, as defined in the draft
commitment letter, for PMA and 510(k)
submissions, with shared outcome goals
for FDA and industry that reach 290
calendar days for PMAs and 108
calendar days for 510(k)s by FY 2022.
Additional details regarding the shared
outcome goals can be found in section
I of the draft commitment letter.
B. Pre-Submissions
FDA will improve the pre-submission
process and ramp up to a performance
goal for written feedback on at least
1,950 pre-submissions within 70 days or
5 calendar days prior to the scheduled
meeting, whichever comes sooner, in
FY2022 (which is equivalent to meeting
the stated timeline for at least 83
percent of an assumed 2,350 presubmissions). Industry will be
responsible for providing draft meeting
minutes within 15 days of the meeting.
Additional details regarding presubmissions can be found in section
II.A. of the draft commitment letter.
mstockstill on DSK3G9T082PROD with NOTICES
C. PMAs
FDA will maintain MDUFA III
performance goals for all PMA
submissions, including supplements.
Additionally, as resources permit, FDA
will issue a MDUFA decision within 60
days of an advisory committee
recommendation and will issue a
decision within 60 days of an
applicant’s response to an approvable
letter. Additional details regarding
PMAs can be found in sections II.B.-D.
of the draft commitment letter.
D. De Novos
FDA will ramp up to a performance
goal for reaching a decision on 70
percent of de novo submissions within
150 days in FY2022. Additional details
regarding de novo submissions can be
found in section II.E. of the draft
commitment letter.
E. 510(k)s
FDA will maintain MDUFA III
performance goals for all 510(k)
VerDate Sep<11>2014
17:36 Oct 06, 2016
Jkt 241001
submissions. Additionally, FDA will
report performance separately for those
reviewed by accredited Third Parties.
Additional details regarding 510(k)s can
be found in section II.F. of the draft
commitment letter.
F. Clinical Laboratory Improvement
Amendments (CLIA) Waiver by
Application Submissions
FDA will improve the CLIA waiver by
application process by establishing a
centralized program management group
within the Office of In Vitro Diagnostics
and Radiological Health, implementing
a Missed MDUFA Decision provision,
hosting CLIA Waiver vendor days, and
further reducing review times for CLIA
Waiver by Application Submissions.
Additional resources have not been
included in the MDUFA agreement for
CLIA Waiver applications. Additional
details regarding CLIA Waiver by
Application Submissions can be found
in section II.G. of the draft commitment
letter.
G. Quality Management
FDA will establish a dedicated
premarket Quality Management team,
which will be responsible for
establishing a quality management
framework for the premarket submission
process in the Center for Devices and
Radiological Health (CDRH) and
conducting routine quality audits.
Additional details regarding Quality
Management can be found in section
III.A. of the draft commitment letter.
H. Employee Recruitment and Retention
FDA will implement a more effective
recruiting and hiring strategy and will
improve employee retention by
applying user fee revenues to retain
high performing supervisors. Additional
details regarding recruitment and
retention can be found in section III.B.
of the draft commitment letter.
I. Information Technology (IT)
FDA will implement IT improvements
that correspond to new performance
goals and reporting, enhance IT
infrastructure to enable collection and
reporting on structured data, develop
and maintain a secure Web-based
application that allows sponsors to view
individual submission status in near
real time, and develop structured
electronic submission templates as a
tool to guide industry’s preparation of
premarket submissions. Additional
details regarding IT can be found in
section III.C. of the draft commitment
letter.
PO 00000
Frm 00055
Fmt 4703
Sfmt 4703
J. Enhanced Use of Consensus
Standards
FDA and industry will establish a
conformity assessment program for
accredited testing laboratories that
evaluate medical devices according to
certain FDA-recognized standards.
Additional details regarding the
enhanced use of consensus standards
can be found in section IV.D. of the draft
commitment letter.
K. Third Party Premarket Review
Program
FDA will strengthen the accredited
person (Third Party) Premarket Review
Program by offering improved training
to Third Party review entities, redacting
predicate review memos for use by third
parties during their reviews, conducting
audits of Third Party review quality,
and publishing performance of
individual Third Party entities, with the
goal of eliminating routine re-review by
FDA of Third Party reviews. Additional
details regarding the Third Party
Premarket Review Program can be found
in section IV.E. of the draft commitment
letter.
L. Patient Engagement
FDA will develop internal expertise
on patient preference information and
patient reported outcomes (PROs) to
enhance the utility of such information
in premarket submissions, publish a
PRO validation guidance, and hold one
or more public meetings. Additional
details regarding patient engagement
can be found in section IV.F. of the draft
commitment letter.
M. Real World Evidence (RWE)
FDA will provide funding for the
National Evaluation System for Health
Technology to conduct pilots to
establish the value of real RWE in the
premarket program. Additional details
regarding RWE can be found in section
IV.H. of the draft commitment letter.
N. Digital Health
FDA will establish a centralized
Digital Health unit to improve
consistency in review of software as a
medical device and software in a
medical device, streamline and align
FDA review processes with software life
cycles, continue engagement in
international harmonization efforts
related to software review, and conduct
other activities related to Digital Health.
Additional details regarding Digital
Health can be found in section IV.I. of
the draft commitment letter.
O. Independent Assessment
FDA and industry will participate in
an independent assessment of the CDRH
E:\FR\FM\07OCN1.SGM
07OCN1
Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices
mstockstill on DSK3G9T082PROD with NOTICES
process for the review of device
applications, including a more complete
assessment of MDUFA III improvements
and outcomes as well as an assessment
of the effectiveness of the MDUFA IV
programs. Additional details regarding
the Independent Assessment can be
found in section V. of the draft
commitment letter.
P. Performance Reports
FDA will continue to report quarterly
on performance against commitments.
Additionally, FDA will separately report
the number and percent of laboratory
developed test (LDT) marketing
applications completed within the
performance goal for 510(k), de novo,
and PMA submissions. FDA committed
to treating LDTs no less favorably than
other devices to which MDUFA
performance goals apply. Additional
details regarding performance reporting
can be found in section VI. of the draft
commitment letter.
In conjunction with the proposed
enhancements and performance goals
outlined in the draft commitment letter,
FDA and industry agreed to the
following proposed changes to the
FD&C Act to ensure that FDA has the
statutory authorities needed to
implement the negotiated programmatic
enhancements:
• FDA and industry are proposing to
modify section 738(a)(2)(A) of the FD&C
Act (21 U.S.C. 379j(a)(2)(A)) to allow for
fees to be collected for de novo
submissions and exempting de novo
submissions from fees when solely for
pediatric conditions for use (section
738(a)(2)(B)(v)(I)).
• FDA and industry are proposing to
modify section 738(c) of the FD&C Act
to reflect the negotiated fee setting
structure. This negotiated structure
allows FDA to collect inflation-adjusted
base fee amounts without any reduction
in fees in the event that submission or
registration volumes are higher than
planned. Any further adjustments
beyond inflation would only be
necessary if projected submission or
registration volumes are lower than
planned such that base fee amounts
would need to be increased in order to
generate the authorized total fee revenue
in a given year.
• The statutory total revenue amounts
and base fee amounts are proposed in
FY2015 dollars such that annual
inflation adjustments will be used to
inflate FY2015 dollars to the
appropriate amounts for each fiscal year
in MDUFA IV.
• FDA is proposing to modify section
738(h)(1)(A) of the FD&C Act to update
the appropriations trigger to provide
assurance to industry that user fees will
VerDate Sep<11>2014
17:36 Oct 06, 2016
Jkt 241001
be additive to budget authority
appropriations.
• FDA and industry are proposing to
delete section 738(i)(4) of the FD&C Act
to eliminate the fifth-year fee offset
because the negotiated fee setting
structure allows FDA to collect and use
inflation-adjusted base fee amounts each
year without any reduction in fees due
to increased submission volume.
Deleting the fee offset provision (section
738(i)(4)) is necessary to implement the
negotiated fee setting structure.
• FDA and industry are proposing to
add a subsection (d) to section 514 of
the FD&C Act (21 U.S.C. 360d)
(Performance standards) to provide
authority for FDA to establish a
conformity assessment program and per
the agreements made during the user fee
reauthorization negotiations. FDA and
industry are proposing to amend section
523 of the FD&C Act (21 U.S.C. 360m)
(Accredited persons) to provide FDA
authority to tailor the scope of the Third
Party review program per the
agreements made during the user fee
reauthorization negotiations.
• FDA and industry are proposing to
amend section 741 of the FD&C Act (21
U.S.C. 379k–1) (Electronic format for
submissions) to provide FDA the
authority to develop and implement
electronic submissions per the
agreements made during the user fee
reauthorization negotiations.
FDA will post the agenda
approximately 5 days before the meeting
at: https://www.fda.gov/ForIndustry/
UserFees/MedicalDeviceUserFee/
ucm454039.htm.
Registration: Registration is free and
available on a first-come, first-served
basis. Persons interested in attending
the MDUFA meeting must register
online by 4 p.m. October 26, 2016. Early
registration is recommended because
facilities are limited and, therefore, FDA
may limit the number of participants
from each organization. If time and
space permit onsite registration on the
day of the meeting, it will be provided
beginning at 8 a.m.
If you need special accommodations
because of a disability, please contact
Joshua St. Pierre, 301–796–9587 or
Joshua.StPierre@fda.hhs.gov no later
than October 19, 2016.
To register for the meeting, please
visit FDA’s Medical Devices News &
Events—Workshops & Conferences
calendar at https://www.fda.gov/
MedicalDevices/NewsEvents/
WorkshopsConferences/default.htm.
(Select this meeting/public workshop
from the posted events list.) Please
provide complete contact information
for each attendee, including name, title,
affiliation, email, and telephone
PO 00000
Frm 00056
Fmt 4703
Sfmt 4703
69833
number. Those without Internet access
should contact Aaron Josephson to
register (see FOR FURTHER INFORMATION
CONTACT). Registrants will receive
confirmation after they have been
accepted. You will be notified if you are
on a waiting list.
Streaming Webcast of the meeting:
This meeting will also be Webcast. The
Webcast link will be available on the
registration Web page after October 26,
2016. Organizations are requested to
register all participants, but to view
using one connection per location. If
you have never attended a Connect Pro
event before, test your connection at
https://collaboration.fda.gov/common/
help/en/support/meeting_test.htm. To
get a quick overview of the Connect Pro
program, visit https://www.adobe.com/
go/connectpro_overview. 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.
Requests to Present: This meeting
includes a public comment session and
topic-focused sessions. During online
registration you may indicate if you
wish to present and which topics you
wish to address during the public
comment session. FDA has included
general topics in this document. FDA
will do its best to accommodate requests
to make public comments. Individuals
and organizations with common
interests are urged to consolidate or
coordinate their presentations, and
request time for a joint presentation.
Following the close of registration, FDA
will determine the amount of time
allotted to each presenter and the
approximate time each oral presentation
is to begin, and will select and notify
participants by October 28, 2016. All
requests to make oral presentations
must be received by the close of
registration on October 26, 2016, at 4
p.m. No commercial or promotional
material will be permitted to be
presented or distributed at the meeting.
FDA is holding this meeting to
provide information on the proposed
recommendations for the
reauthorization of the MDUFA for FYs
2018 through 2022. In order to permit
the widest possible opportunity to
obtain public comment, FDA is
soliciting either electronic or written
comments on all aspects of the meeting
topics. The docket will open when the
draft commitment letter and proposed
statutory changes are made public,
which is expected to be in mid-October.
The materials will be posted on this
Web site at: https://www.fda.gov/
ForIndustry/UserFees/
MedicalDeviceUserFee/ucm454039.htm.
E:\FR\FM\07OCN1.SGM
07OCN1
69834
Federal Register / Vol. 81, No. 195 / Friday, October 7, 2016 / Notices
The docket will close 30 days after
those documents are posted.
Transcripts: Please be advised that as
soon as a transcript is available, it will
be accessible at in the docket at https://
www.regulations.gov. It may be viewed
at the Division of Dockets Management
(see ADDRESSES). A transcript will also
be available in either hardcopy or on
CD–ROM, after submission of a
Freedom of Information request. The
Freedom of Information office address is
available on the Agency’s Web site at
https://www.fda.gov. A link to the
transcripts will also be available
approximately 45 days after the public
workshop on the Internet at https://
www.fda.gov/ForIndustry/UserFees/
MedicalDeviceUserFee/ucm454039.htm.
(Select this meeting from the posted
events list).
Dated: October 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016–24237 Filed 10–6–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Agency Information Collection
Activities: Submission to OMB for
Review and Approval; Public Comment
Request; Data Use Agreement and
Supplement for 2014 Health Center
Patient Survey
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Notice.
AGENCY:
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, HRSA submitted
an Information Collection Request (ICR)
to the Office of Management and Budget
(OMB) for review and approval.
Comments submitted during the first
public review of this ICR will be
provided to OMB. OMB will accept
further comments from the public
during the review and approval period.
SUMMARY:
Comments on this ICR should be
received no later than November 7,
2016.
ADDRESSES: Submit your comments,
including the ICR title, to the desk
officer for HRSA, either by email to
OIRA_submission@omb.eop.gov or by
fax to 202–395–5806.
FOR FURTHER INFORMATION CONTACT: To
request a copy of the clearance requests
submitted to OMB for review, email the
HRSA Information Collection Clearance
Officer at paperwork@hrsa.gov or call
(301) 443–1984.
SUPPLEMENTARY INFORMATION:
Information Collection Request Title:
Data Use Agreement and Supplement
for 2014 Health Center Patient Survey.
OMB No.: 0906–xxxx—NEW.
Abstract: The Health Center Patient
Survey (HCPS), sponsored by HRSA’s
Bureau of Primary Health Care (BPHC),
surveyed patients who use health
centers funded under Section 330 of the
Public Health Service Act. HCPS
collects data on health center patients’
sociodemographic characteristics,
health conditions, health behaviors,
access to and utilization of health care
services, and satisfaction with health
care. Survey results come from inperson, one-on-one interviews with
patients and are nationally
representative of the Health Center
program patient population. To inform
BPHC and HHS policy, funding, and
planning decisions, the survey
investigated how well HRSA-supported
sites meet health care needs of the
medically underserved and assessed
how patients perceive the quality of
their care.
The HCPS is unique because it
focuses on comprehensive patient-level
data. These and other features of the
data will provide researchers and
policymakers the capacity to
empirically explore policy relevant
topics relevant to the Health Center
program using up-to-date information.
Prior to releasing this information,
BPHC will request prospective users to
fill out a ‘‘Data Use Agreement’’ (DUA).
BPHC uses DUAs as legal binding
agreements when an external entity
(e.g., contractor, private industry,
academic institution, other federal
DATES:
government agency, or state agency)
requests the use of BPHC personally/
organizationally identifiable data that is
covered by the Privacy Act of 1974. The
agreement delineates the confidentiality
requirements of the Privacy Act,
security safeguards, and BPHC’s data
use policies and procedures. The DUA
will serve as both a means of informing
data users of these requirements and a
means of obtaining their agreement to
abide by these requirements.
Need and Proposed Use of the
Information: Before allowing access to
unrestricted data that contains sensitive
grantee and patient information that is
protected by the Privacy Act of 1974,
prospective users will submit a signed
DUA and describe what proposed
research they intend to undertake in
using the dataset. A BPHC workgroup
will determine whether the project is an
appropriate and legitimate use of the
data. The criteria to determine
admissible projects will include: (1)
Relevance of the topic of study to
BPHC/HHS policy; (2) feasibility of the
project given the parameters described
in DUA supplemental; and (3) the
proposed end-use of the research that
will be undertaken.
Likely Respondents: Prospective
researchers in academia, private
contractors, and Primary Care
Associations/Health Center grantee
organizations.
Burden Statement: Burden in this
context means the time expended by
persons to generate, maintain, retain,
disclose or provide the information
requested. This includes the time
needed to review instructions; to
develop, acquire, install and utilize
technology and systems for the purpose
of collecting, validating and verifying
information, processing and
maintaining information, and disclosing
and providing information; to train
personnel and to be able to respond to
a collection of information; to search
data sources; to complete and review
the collection of information; and to
transmit or otherwise disclose the
information. The total annual burden
hours estimated for this ICR are
summarized in the table below.
mstockstill on DSK3G9T082PROD with NOTICES
TOTAL ESTIMATED ANNUALIZED BURDEN HOURS
Number of
respondents
Form name
Number of
responses per
respondent
Total
responses
Average
burden per
response
(in hours)
Total burden
hours
DUA ......................................................................................
DUA Supplemental ..............................................................
20
20
1
1
20
20
0.25
1.25
5
25
Total ..............................................................................
40
........................
40
........................
30
VerDate Sep<11>2014
17:36 Oct 06, 2016
Jkt 241001
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
E:\FR\FM\07OCN1.SGM
07OCN1
]]>Agencies
[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Notices]
[Pages 69829-69834]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-24237]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-N-2872]
Medical Device User Fee Amendments; Public Meeting; Request for
Comments
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of public meeting; request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA) is announcing a public
meeting entitled ``Medical Device User Fee Amendments.'' The purpose of
the meeting is to discuss proposed recommendations for the
reauthorization of the Medical Device User Fee Amendments (MDUFA) for
fiscal years (FYs) 2018 through 2022. MDUFA authorizes FDA to collect
fees and use them for the process for the review of medical device
applications. The current legislative authority for MDUFA expires
October 1, 2017. At that time, new legislation will be required for FDA
to continue collecting medical device user fees in future fiscal years.
Following discussions with the device industry and periodic
consultations with public stakeholders, the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) directs FDA to publish the recommendations
for the reauthorized program in the Federal Register, hold a meeting at
which the public may present its views on such recommendations, and
provide for a period of 30 days for the public to provide written
comments on such recommendations. FDA will then
[[Page 69830]]
consider such public views and comments and revise such recommendations
as necessary.
DATES: The public meeting will be held on November 2, 2016, from 9 a.m.
to 5 p.m. Submit electronic or written comments to the public docket by
November 14, 2016. When the materials are available, they will be in
the docket and posted on this Web site at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm454039.htm. See
REGISTRATION section below regarding how to register for this public
meeting.
ADDRESSES: The public meeting will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2016-N-2872 for ``Medical Device User Fee Amendments; Public
Meeting.'' The commitment letter and proposed statutory changes are
expected to be made public in mid-October. At that time, the materials
will be posted in the docket and on this Web site at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm454039.htm.
The docket will close on November 14, 2016. Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly available at https://www.regulations.gov or at
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert 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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Aaron Josephson, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, rm. 5449, Silver Spring, MD 20993, 301-796-
5178, Aaron.Josephson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing its intention to hold a public meeting to discuss
proposed recommendations for the reauthorization of MDUFA, which
authorizes FDA to collect user fees and use them for the process for
the review of device applications until September 30, 2017. Without new
legislation, FDA will no longer be able to collect user fees for future
fiscal years to provide funds for the process for the review of device
applications. As required by section 738A(b)(2), (3), and (6) of the
FD&C Act (21 U.S.C. 379j-1(b)(2), (3), and (6)), FDA obtained prior
public input and negotiated an agreement with regulated industry while
periodically consulting with patient and consumer advocacy groups and
making minutes of negotiation and stakeholder meetings publicly
available. Section 738A(b)(4) of the FD&C Act requires that, after
holding negotiations with regulated industry and before transmitting
the Agency's final recommendations to Congress for the reauthorized
program (MDUFA IV), we do the following: (1) Present the draft
recommendations to the Committee on Energy and Commerce of the U.S.
House of Representatives and the Committee on Health, Education, Labor,
and Pensions of the U.S. Senate; (2) publish the draft recommendations
in the Federal Register; (3) provide a period of 30 days for the public
to submit written comments on the draft recommendations; (4) hold a
meeting at which the public may present its views on the draft
recommendations; and (5) after consideration of public views and
comments, revise the draft recommendations as necessary. This notice,
the 30-day comment period, and the public meeting will satisfy certain
of
[[Page 69831]]
these requirements. After the public meeting, we will revise the draft
recommendations as necessary. In addition, the Agency will present the
draft recommendations to the Congressional committees.
The purpose of the meeting is for the public to present its views
on the draft recommendations for the reauthorized program (MDUFA IV).
In general, the meeting format will include a brief presentation by
FDA, but will focus on hearing from different stakeholder interest
groups (such as patient advocates, consumer advocates, industry, health
care professionals, and scientific and academic experts). The Agency
will also provide an opportunity for individuals to make presentations
at the meeting and for organizations and individuals to submit written
comments to the docket before and after the meeting. The following
information is provided to help potential meeting participants better
understand the history and evolution of the medical device user fee
program and the current status of the MDUFA IV draft recommendations.
II. What is MDUFA and what does it do?
MDUFA is the law that authorizes FDA to collect fees from device
companies that register their establishments, submit applications to
market devices, and make other types of submissions. In the years
preceding enactment of the Medical Device User Fee and Modernization
Act of 2002 (MDUFMA) (Pub. L. 107-250), FDA's medical device program
suffered a long-term, significant loss of resources that undermined the
program's capacity and performance. MDUFMA was enacted ``in order to
provide FDA with the resources necessary to better review medical
devices, to enact needed regulatory reforms so that medical device
manufacturers can bring their safe and effective devices to the
American people at an earlier point in time, and to ensure that
reprocessed medical devices are as safe and effective as original
devices.'' H.R. Rep. 107-728 at p. 21 (Oct. 7, 2002). MDUFMA was
authorized for 5 years and contained two important features that relate
to reauthorization:
User fees for the review of medical device premarket
applications, reports, supplements, and premarket notification
submissions provided additional resources to make FDA reviews more
timely, predictable, and transparent to applicants. User fees and
appropriations for the medical device program helped FDA expand
available expertise, modernized its information management systems,
provided new review options, and provided more guidance to prospective
submitters. The ultimate goal was for FDA to clear and approve safe and
effective medical devices more rapidly, benefiting applicants, the
health care community, and most importantly, patients.
Negotiated performance goals for many types of premarket
reviews provided FDA with benchmarks for measuring review improvements.
These quantifiable goals became more demanding each year and included
FDA decision goals and cycle goals (cycle goals refer to FDA actions
prior to a final action on a submission). Under MDUFMA, FDA also agreed
to several other commitments that did not have specific timeframes or
direct measures of performance, such as expanding the use of meetings
with industry, maintenance of current performance in review areas where
specific performance goals had not been identified, and publication of
additional guidance documents.
Medical device user fees and increased appropriations were viewed
by FDA, Congress, and industry stakeholders as essential to support
high-quality, timely medical device reviews, and other activities
critical to the device review program.
MDUFMA provided for--and reauthorizations have maintained--fee
discounts and waivers for qualifying small businesses. Small businesses
make up a large proportion of the medical device industry, and these
discounts and waivers helped reduce the financial impact of user fees
on this sector of the device industry, which plays an important role in
fostering innovation.
Since MDUFMA was first enacted in 2002, it has been reauthorized
twice (the 2007 Medical Device User Fee Amendments (MDUFA II) and the
2012 Medical Device User Fee Amendments (MDUFA III)). Under MDUFA III,
which has been in effect since 2012 and will expire on October 1, 2017,
FDA has met or exceeded nearly all submission performance goals while
implementing program enhancements designed to ensure more timely access
to safe and effective medical devices. Information about FDA's
performance is available in the yearly and quarterly MDUFA performance
reports, which are online at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/UCM2007450.htm and https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm452535.htm.
User fees and related performance goals have played an important
role in providing resources and supporting the management systems for
ensuring that safe and effective medical devices are available to
patients in a timely manner.
III. Proposed MDUFA IV Recommendations
In preparing the proposed recommendations to Congress for MDUFA
reauthorization, FDA conducted discussions with the device industry and
consulted with stakeholders, as required by the FD&C Act. The Agency
began the MDUFA reauthorization process by publishing a notice in the
Federal Register requesting public input on the reauthorization and
announcing a public meeting that was held on July 13, 2015. The meeting
included presentations by FDA and a series of panels with
representatives of different stakeholder groups, including patient and
consumer advocacy groups, regulated industry, and health care
professionals. The materials from the meeting, including a transcript
and Webcast recording, can be found at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm445541.htm.
From September 2015 through August 2016, FDA conducted negotiations
with representatives of the device industry: The Advanced Medical
Technology Association; the Medical Device Manufacturers Association;
the Medical Imaging and Technology Alliance; and, the American Clinical
Laboratory Association. During its negotiations with the regulated
industry, FDA also held monthly consultations with stakeholders
representing patient and consumer interests. As directed by Congress,
FDA posted minutes of these meetings on its Web site at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm454039.htm.
The proposed recommendations for MDUFA IV address many priorities
identified by public stakeholders, the device industry, and FDA. While
some of the proposed recommendations are new, many either build on
successful enhancements or refine elements from the existing program.
FDA intends to post the full text of the proposed MDUFA IV commitment
letter and proposed statutory changes at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm454039.htm before the
public meeting. Each recommendation is briefly described with reference
to the applicable section of the draft commitment letter.
A. Shared Outcome Goals
FDA and representatives of the device industry believe that the
process
[[Page 69832]]
improvements outlined in the draft commitment letter, when implemented
by all parties as intended, should further reduce the average Total
Time to Decision for PMA applications and 510(k) submissions, provided
that the total funding of the device review program adheres to the
assumptions underlying the agreement. Reducing average Total Time to
Decision is an important aspect of the ultimate goal of the user fee
program, so that safe and effective devices reach patients and health
care professionals more quickly. FDA will continue reporting, on an
annual basis, the average Total Time to Decision, as defined in the
draft commitment letter, for PMA and 510(k) submissions, with shared
outcome goals for FDA and industry that reach 290 calendar days for
PMAs and 108 calendar days for 510(k)s by FY 2022. Additional details
regarding the shared outcome goals can be found in section I of the
draft commitment letter.
B. Pre-Submissions
FDA will improve the pre-submission process and ramp up to a
performance goal for written feedback on at least 1,950 pre-submissions
within 70 days or 5 calendar days prior to the scheduled meeting,
whichever comes sooner, in FY2022 (which is equivalent to meeting the
stated timeline for at least 83 percent of an assumed 2,350 pre-
submissions). Industry will be responsible for providing draft meeting
minutes within 15 days of the meeting. Additional details regarding
pre-submissions can be found in section II.A. of the draft commitment
letter.
C. PMAs
FDA will maintain MDUFA III performance goals for all PMA
submissions, including supplements. Additionally, as resources permit,
FDA will issue a MDUFA decision within 60 days of an advisory committee
recommendation and will issue a decision within 60 days of an
applicant's response to an approvable letter. Additional details
regarding PMAs can be found in sections II.B.-D. of the draft
commitment letter.
D. De Novos
FDA will ramp up to a performance goal for reaching a decision on
70 percent of de novo submissions within 150 days in FY2022. Additional
details regarding de novo submissions can be found in section II.E. of
the draft commitment letter.
E. 510(k)s
FDA will maintain MDUFA III performance goals for all 510(k)
submissions. Additionally, FDA will report performance separately for
those reviewed by accredited Third Parties. Additional details
regarding 510(k)s can be found in section II.F. of the draft commitment
letter.
F. Clinical Laboratory Improvement Amendments (CLIA) Waiver by
Application Submissions
FDA will improve the CLIA waiver by application process by
establishing a centralized program management group within the Office
of In Vitro Diagnostics and Radiological Health, implementing a Missed
MDUFA Decision provision, hosting CLIA Waiver vendor days, and further
reducing review times for CLIA Waiver by Application Submissions.
Additional resources have not been included in the MDUFA agreement for
CLIA Waiver applications. Additional details regarding CLIA Waiver by
Application Submissions can be found in section II.G. of the draft
commitment letter.
G. Quality Management
FDA will establish a dedicated premarket Quality Management team,
which will be responsible for establishing a quality management
framework for the premarket submission process in the Center for
Devices and Radiological Health (CDRH) and conducting routine quality
audits. Additional details regarding Quality Management can be found in
section III.A. of the draft commitment letter.
H. Employee Recruitment and Retention
FDA will implement a more effective recruiting and hiring strategy
and will improve employee retention by applying user fee revenues to
retain high performing supervisors. Additional details regarding
recruitment and retention can be found in section III.B. of the draft
commitment letter.
I. Information Technology (IT)
FDA will implement IT improvements that correspond to new
performance goals and reporting, enhance IT infrastructure to enable
collection and reporting on structured data, develop and maintain a
secure Web-based application that allows sponsors to view individual
submission status in near real time, and develop structured electronic
submission templates as a tool to guide industry's preparation of
premarket submissions. Additional details regarding IT can be found in
section III.C. of the draft commitment letter.
J. Enhanced Use of Consensus Standards
FDA and industry will establish a conformity assessment program for
accredited testing laboratories that evaluate medical devices according
to certain FDA-recognized standards. Additional details regarding the
enhanced use of consensus standards can be found in section IV.D. of
the draft commitment letter.
K. Third Party Premarket Review Program
FDA will strengthen the accredited person (Third Party) Premarket
Review Program by offering improved training to Third Party review
entities, redacting predicate review memos for use by third parties
during their reviews, conducting audits of Third Party review quality,
and publishing performance of individual Third Party entities, with the
goal of eliminating routine re-review by FDA of Third Party reviews.
Additional details regarding the Third Party Premarket Review Program
can be found in section IV.E. of the draft commitment letter.
L. Patient Engagement
FDA will develop internal expertise on patient preference
information and patient reported outcomes (PROs) to enhance the utility
of such information in premarket submissions, publish a PRO validation
guidance, and hold one or more public meetings. Additional details
regarding patient engagement can be found in section IV.F. of the draft
commitment letter.
M. Real World Evidence (RWE)
FDA will provide funding for the National Evaluation System for
Health Technology to conduct pilots to establish the value of real RWE
in the premarket program. Additional details regarding RWE can be found
in section IV.H. of the draft commitment letter.
N. Digital Health
FDA will establish a centralized Digital Health unit to improve
consistency in review of software as a medical device and software in a
medical device, streamline and align FDA review processes with software
life cycles, continue engagement in international harmonization efforts
related to software review, and conduct other activities related to
Digital Health. Additional details regarding Digital Health can be
found in section IV.I. of the draft commitment letter.
O. Independent Assessment
FDA and industry will participate in an independent assessment of
the CDRH
[[Page 69833]]
process for the review of device applications, including a more
complete assessment of MDUFA III improvements and outcomes as well as
an assessment of the effectiveness of the MDUFA IV programs. Additional
details regarding the Independent Assessment can be found in section V.
of the draft commitment letter.
P. Performance Reports
FDA will continue to report quarterly on performance against
commitments. Additionally, FDA will separately report the number and
percent of laboratory developed test (LDT) marketing applications
completed within the performance goal for 510(k), de novo, and PMA
submissions. FDA committed to treating LDTs no less favorably than
other devices to which MDUFA performance goals apply. Additional
details regarding performance reporting can be found in section VI. of
the draft commitment letter.
In conjunction with the proposed enhancements and performance goals
outlined in the draft commitment letter, FDA and industry agreed to the
following proposed changes to the FD&C Act to ensure that FDA has the
statutory authorities needed to implement the negotiated programmatic
enhancements:
FDA and industry are proposing to modify section
738(a)(2)(A) of the FD&C Act (21 U.S.C. 379j(a)(2)(A)) to allow for
fees to be collected for de novo submissions and exempting de novo
submissions from fees when solely for pediatric conditions for use
(section 738(a)(2)(B)(v)(I)).
FDA and industry are proposing to modify section 738(c) of
the FD&C Act to reflect the negotiated fee setting structure. This
negotiated structure allows FDA to collect inflation-adjusted base fee
amounts without any reduction in fees in the event that submission or
registration volumes are higher than planned. Any further adjustments
beyond inflation would only be necessary if projected submission or
registration volumes are lower than planned such that base fee amounts
would need to be increased in order to generate the authorized total
fee revenue in a given year.
The statutory total revenue amounts and base fee amounts
are proposed in FY2015 dollars such that annual inflation adjustments
will be used to inflate FY2015 dollars to the appropriate amounts for
each fiscal year in MDUFA IV.
FDA is proposing to modify section 738(h)(1)(A) of the
FD&C Act to update the appropriations trigger to provide assurance to
industry that user fees will be additive to budget authority
appropriations.
FDA and industry are proposing to delete section 738(i)(4)
of the FD&C Act to eliminate the fifth-year fee offset because the
negotiated fee setting structure allows FDA to collect and use
inflation-adjusted base fee amounts each year without any reduction in
fees due to increased submission volume. Deleting the fee offset
provision (section 738(i)(4)) is necessary to implement the negotiated
fee setting structure.
FDA and industry are proposing to add a subsection (d) to
section 514 of the FD&C Act (21 U.S.C. 360d) (Performance standards) to
provide authority for FDA to establish a conformity assessment program
and per the agreements made during the user fee reauthorization
negotiations. FDA and industry are proposing to amend section 523 of
the FD&C Act (21 U.S.C. 360m) (Accredited persons) to provide FDA
authority to tailor the scope of the Third Party review program per the
agreements made during the user fee reauthorization negotiations.
FDA and industry are proposing to amend section 741 of the
FD&C Act (21 U.S.C. 379k-1) (Electronic format for submissions) to
provide FDA the authority to develop and implement electronic
submissions per the agreements made during the user fee reauthorization
negotiations.
FDA will post the agenda approximately 5 days before the meeting
at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm454039.htm.
Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending the MDUFA meeting
must register online by 4 p.m. October 26, 2016. Early registration is
recommended because facilities are limited and, therefore, FDA may
limit the number of participants from each organization. If time and
space permit onsite registration on the day of the meeting, it will be
provided beginning at 8 a.m.
If you need special accommodations because of a disability, please
contact Joshua St. Pierre, 301-796-9587 or Joshua.StPierre@fda.hhs.gov
no later than October 19, 2016.
To register for the meeting, please visit FDA's Medical Devices
News & Events--Workshops & Conferences calendar at https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select
this meeting/public workshop from the posted events list.) Please
provide complete contact information for each attendee, including name,
title, affiliation, email, and telephone number. Those without Internet
access should contact Aaron Josephson to register (see FOR FURTHER
INFORMATION CONTACT). Registrants will receive confirmation after they
have been accepted. You will be notified if you are on a waiting list.
Streaming Webcast of the meeting: This meeting will also be
Webcast. The Webcast link will be available on the registration Web
page after October 26, 2016. Organizations are requested to register
all participants, but to view using one connection per location. If you
have never attended a Connect Pro event before, test your connection at
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
To get a quick overview of the Connect Pro program, visit https://www.adobe.com/go/connectpro_overview. 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.
Requests to Present: This meeting includes a public comment session
and topic-focused sessions. During online registration you may indicate
if you wish to present and which topics you wish to address during the
public comment session. FDA has included general topics in this
document. FDA will do its best to accommodate requests to make public
comments. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations, and request time for
a joint presentation. Following the close of registration, FDA will
determine the amount of time allotted to each presenter and the
approximate time each oral presentation is to begin, and will select
and notify participants by October 28, 2016. All requests to make oral
presentations must be received by the close of registration on October
26, 2016, at 4 p.m. No commercial or promotional material will be
permitted to be presented or distributed at the meeting.
FDA is holding this meeting to provide information on the proposed
recommendations for the reauthorization of the MDUFA for FYs 2018
through 2022. In order to permit the widest possible opportunity to
obtain public comment, FDA is soliciting either electronic or written
comments on all aspects of the meeting topics. The docket will open
when the draft commitment letter and proposed statutory changes are
made public, which is expected to be in mid-October. The materials will
be posted on this Web site at: https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm454039.htm.
[[Page 69834]]
The docket will close 30 days after those documents are posted.
Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at in the docket at https://www.regulations.gov. It may be viewed at the Division of Dockets
Management (see ADDRESSES). A transcript will also be available in
either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. The Freedom of Information office address is
available on the Agency's Web site at https://www.fda.gov. A link to the
transcripts will also be available approximately 45 days after the
public workshop on the Internet at https://www.fda.gov/ForIndustry/UserFees/MedicalDeviceUserFee/ucm454039.htm. (Select this meeting from
the posted events list).
Dated: October 3, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-24237 Filed 10-6-16; 8:45 am]
BILLING CODE 4164-01-P
