
[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]


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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.

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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: http://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 http://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: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://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 http://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: http://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 http://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 http://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: http://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 http://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: http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/UserFeeReports/PerformanceReports/UCM2007450.htm and http://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 http://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: http://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: http://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

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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: http://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 http://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 http://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: http://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 http://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 http://www.fda.gov. A link to the 
transcripts will also be available approximately 45 days after the 
public workshop on the Internet at http://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


