[Federal Register Volume 77, Number 6 (Tuesday, January 10, 2012)]
[Notices]
[Pages 1481-1482]
[FR Doc No: 2012-222]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-276-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Gulf Crossing Pipeline Company LLC submits tariff
filing per 154.204: Antero 2 to Tenaska 243 Capacity Release Negotiated
Rate Agreement Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5084.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-277-000.
    Applicants: Gulf Crossing Pipeline Company LLC.
    Description: Gulf Crossing Pipeline Company LLC submits tariff
filing per 154.204: Antero 3 to Tenaska 244 Capacity Release Negotiated
Rate Agreement Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5087.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-278-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: BG Energy 39431 Negotiated Rate Agreement Filing to be
effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5128.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-279-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: HK 37367 to Sequent 39472 Capacity Release Negotiated Rate
Agreement Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5129.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-280-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: HK 37731 to Sequent 39473 Capacity Release Negotiated Rate
Agreement Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.

    Accession Number: 20120103-5130.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-281-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: HK 37731 to Spark Energy Gas 39466 Capacity Release
Negotiated Rate Agreement Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5131.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-282-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: HK 37731 to Texla 39468 Capacity Release Negotiated Rate
Agreement Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5132.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-283-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: HK 37731 to Texla 39471 Capacity Release Negotiated Rate
Agreement Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5133.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-284-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: JW 34689 to QWest 34962 Capacity Release Negotiated Rate
Agreement Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5134.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-285-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: JW 34690 to QWest 34963 Capacity Release Negotiated Rate
Agreement Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5135.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-286-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: Questar 37657-12 Amendment to Negotiated Rate Agreement
Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5136.
    Comments Due: 5 p.m. ET 1/17/12.

    Docket Numbers: RP12-287-000.
    Applicants: Gulf South Pipeline Company, LP.
    Description: Gulf South Pipeline Company, LP submits tariff filing
per 154.204: HK 37733 to Texla 39467 Capacity Release Negotiated Rate
Agreement Filing to be effective 1/1/2012.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5137.
    Comments Due: 5 p.m. ET 1/17/12.

    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.

Filings in Existing Proceedings

    Docket Numbers: RP12-128-002.
    Applicants: Algonquin Gas Transmission, LLC.
    Description: Algonquin Gas Transmission, LLC submits tariff filing
per 154.203: Docket RP12-128-000 Compliance Filing to be effective 12/
2/2011.
    Filed Date: 1/3/12.
    Accession Number: 20120103-5205.
    Comments Due: 5 p.m. ET 1/17/12.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service can be found at:
http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other
information, call<PHONE_NUMBER> (toll free). For TTY, call (202) 502-
8659.

    Dated: January 4, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary
[FR Doc. 2012-222 Filed 1-9-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 195 (Friday, October 7, 2016)]
[Notices]
[Pages 69829-69834]
[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

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<EMAIL_ADDRESS>
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

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

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

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,<PHONE_NUMBER> or<EMAIL_ADDRESS>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.

    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


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM Subject: 4 Chlorophenoxyacetic Acid ( 4 CPA) TRED: Estimated Drinking Water Concentrations for 4 CPA for Use in the Human Health Drinking Water Risk Assessment. ( Chemical Code 019401 ; DP Barcode D284988)

To: Christina Scheltema, Chemical Review Manager Reregistration Branch III Special Review and Reregistration Division ( 7505C)

From: Mark Corbin, Environmental Scientist Environmental Risk Branch I Environmental Fate and Effects Division ( 7507C)

Thru: Sid Abel, Branch Chief Environmental Risk Branch I Environmental Fate and Effects Division ( 7507C)

This memorandum transmits the FQPA drinking water assessment for the tolerance reassessment of 4 CPA. The use of 4 CPA is limited to indoor use as a root suppression agent for mung bean sprouts and therefore the agency only required the submission of hydrolysis data in support of the registration of 4 CPA. No drinking water assessment has been completed at this time for 4 CPA since an indoor use is expected to minimally impact drinking water sources.

Environmental Fate Assessment Hydrolysis data were the only data required to support the indoor use ( e. g. root suppression of mung bean sprouts) of 4 CPA. From an acceptable study, parent 4 CPA was stable with a reported half life of greater than 30 days to abiotic hydrolysis in three buffer solutions ( MRID 42819601). No additional environmental fate data are required to support the use of 4 CPA on mung beans.

4 CPA is expected to be mobile in soil and aquatic environments because it will exist as an anion ( dissociated carboxylic acid) in most environments. The soil partitioning coefficient ( Kd) for 4 CPA cannot be estimated from structural analysis. Disposal of 4 CPA treated water, after treatment of mung beans, should be performed in compliance with all appropriate discharge permits and requirements. By analogy, the phenoxy herbicides as a class are generally degraded under aerobic conditions by microbially mediated processes and aqueous photolysis, and are generally stable to hydrolysis, soil photolysis, and under anaerobic conditions.

Conclusions No estimated exposure concentrations for drinking water are presented in this assessment due to the limited indoor use of 4 CPA and due to the limited environmental fate data. However, should additional uses for 4 CPA be considered EFED should be consulted to evaluate whether these uses may impact drinking water sources and what additional data may be needed for registration.


Enviro-Fill<EMAIL_ADDRESS>
07/25/2006 08:16 AM

To:  Michael Samulski/AA/USEPA/US@EPA, Alan Stout/AA/USEPA/US@EPA

cc:

Subject:  Overfill Prevention System developments

Mike and Alan,

I just read the EPA Outreach Briefing from the NMMA website and thought
this would be a good time to let you know about some developments with
the OPS. I have been in contact with several of the large fuel nozzle
manufactures and all of them currently manufacture a nozzle with a spout
that would be compatible with our system. I have received samples
nozzles from a few of the manufacturers and I’m waiting for a couple
more, then I will do some tests to confirm that off the shelf nozzle
from several manufacturers will work with our system. One concern I had
was whether the nozzles would be E-85 compatible, but the engineering
people I spoke with said it was not a problem to make the necessary
changes. All were eager to be involved in developing a new market for
their product.

Mike you had mentioned in a past e-mail that you wondered how my OPS
would perform in the BoatUS test. I had it tested in January by IMANNA
Laboratory and have attached their report. They ran a test on the system
to verify reliability and performance. This test was similar to the
BoatUS test only we chose an average fill rate of 15 gpm. The fill rate
is not important with our system because we don’t rely on fuel backing
up the fill hose to stop the nozzle flow. I did however want the test to
be realistic. There is a list of fuel docks and their dispensing rates
attached. These were gathered in April while trying to establish an
average dispensing rate at real fuel docks across the country.

Also attached are some photos of a new component that will make the OPS
adaptable to any tank with a fuel level sending unit. Fuel level senders
use a standard SAE 5 hole pattern. The adapter we have developed is
installed below the sending unit and extends to a predetermined level in
the tank. This has eliminated the need to modify anything the boat
manufacturers are currently using to install the OPS. With a standard
marine nozzle in place, any boat owner could retrofit their boat with an
OPS. By simply removing 5 screws and installing our adapter on the tank,
then 3 screws and swapping our fill fitting on the deck they would
benefit from the same overfill protection.

Please keep me posted on any developments in the rule making.

Thanks,

Steve

Enviro-Fill, Inc.

<EMAIL_ADDRESS>
443-569-9301