OMB # 2060 0564 Expiration Date: 8/ 31/ 05 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS I CONTROLLED SUBSTANCE REPORT: NOTIFICATION OF METHYL BROMIDE TRANSFERS ( Sec 82.12 ( a)( 1))

SECTION 1 TRANSFEROR IDENTIFICATION 1.1 Date of Submission 1.2 Number of Transactions Reported 1.3 Number of Pages Submitted 1.4 Company Information Company Name Street Address City State Zip Code 1.5 Company Contact Identification Reporting Company Contact Person Phone Number Fax Number E mail Address 1.6 Signature of Reporting Company Representative I certify under penalty of law that I have personally examined and am familiar with the information submitted in this and all attached documents, and that based on my inquiry of those individuals immediately responsible for obtaining the information, I believe that the submitted information is true, accurate, and complete. I am aware that there are significant penalties for submitting false information, including the possibility of fine and imprisonment.

Name Title Signature Date SEND COMPLETED FORMS TO: Tracking System Program Manager Stratospheric Protection Division U. S. EPA ( 6205J) 1200 Pennsylvania Avenue, NW Washington, DC 20460 Information in reports submitted in compliance with the final rule may be claimed as confidential. A company may assert a claim of confidentiality for information submitted by clearly marking that information as confidential. Such information shall be treated in accordance with EPA's procedures for information claimed as confidential at 40 CFR Part 2, Subpart B, and will only be disclosed by the means set forth in the subpart. If no claim of confidentiality accompanies the report when it is received by EPA, it may be made public without further notice to the company ( 40 CFR 2.203).

Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. Public reporting burden for this collection of information is estimated to average 2 hours per response. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations are listed in 40 CFR Part 9 and 48 CFR Chapter 15. Send comments on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including through the use of automated collection techniques to the Director, OPPE Regulatory Information Division, U. S. Environmental Protection Agency ( 2137), 1200 Pennsylvania Avenue, NW, Washington, D. C. 20460; and to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Officer for EPA. Include the EPA ICR number and OMB control number in any correspondence. DO NOT SEND THIS FORM TO THESE ADDRESSES; ONLY SEND COMMENTS.

EPA FORM 2179.01 T 1MB, Revised 4/ 05 OMB # 2060 0564 Expiration Date: 8/ 31/ 05 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS I CONTROLLED SUBSTANCE REPORT: NOTIFICATION OF METHYL BROMIDE TRANSFERS ( Sec 82.12 ( a)( 1))

SECTION 2 TRANSACTION RECORD ( Reproduce additional sheets as needed)

TRANSACTION #

2.1 Transferee Identification Transferee Company Name Transferee Contact Person Street Address City State Zip Code Phone Number Fax Number Check only one: Pre Plant CUA Post Harvest CUA Article 5 Allowances Critical Stock Allowance ( CSA)

2.2 Type of Allowances Transferred ( check only one) Current Year Allowances Baseline Year Allowances 2.3 Number of Allowances Being Transferred ( kg)

2.4 Amount of Offset ( kg)

For Pre Plant and Post Harvest CUAs, 0.001 x Section 2.3;

For Article 5 Allowances, 0.01 x Section 2.3;

For CSAs no offset is applied, proceed to Section 2.5 2.5 Number of Allowances Subtracted from Transferor's Balance of Chemical Being Transferred ( Section 2.3 + Section 2.4) ( kg)

2.6 Number of Allowances Being Received ( kg)

EPA FORM 2179.01 T 2MB, Revised 4/ 05 OMB # 2060 0564 Expiration Date: 8/ 31/ 05 U. S. Environmental Protection Agency STRATOSPHERIC OZONE PROTECTION PROGRAM CLASS I CONTROLLED SUBSTANCE REPORT: NOTIFICATION OF METHYL BROMIDE TRANSFERS ( Sec 82.12 ( a)( 1))

SECTION 3 UNEXPENDED BALANCE SUMMARY 3.1 Balance of Unexpended Methyl Bromide Allowances Prior to Trades Reported A B C D Balance of Unexpended Pre Plant Critical Use Allowances Balance of Unexpended Post Harvest Critical Use Allowances Balance of Unexpended Article 5 Allowances Balance of Unexpended Critical Stock Allowances EPA FORM 2179.01 T 3MB, Revised 4/ 05


[Federal Register Volume 79, Number 100 (Friday, May 23, 2014)]
[Notices]
[Pages 29837-29838]
[FR Doc No: 2014-11957]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA-2013-0470]

Hours of Service of Drivers: American Trucking Associations
(ATA); Application for Exemption

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of application for exemption; request for comments.

-----------------------------------------------------------------------

SUMMARY: FMCSA announces that it has received an application from the
ATA for an exemption from the 14-hour provision of the Agency's hours-
of-service regulations to enable certain drivers to exclude waiting
time at a natural gas or oil well site from their calculations of on-
duty time. Currently, only specially trained drivers of commercial
motor vehicles (CMVs) that are specially constructed to service oil and
natural gas extraction sites may employ this provision. ATA proposes
that FMCSA by a limited 2-year exemption that may be renewed, permit
exclusion of such waiting time by drivers of CMVs who are exclusively
engaged in servicing oil and natural gas extraction sites and have the
opportunity to obtain rest while waiting at such sites. FMCSA requests
public comment on ATA's application for exemption.

DATES: Comments must be received on or before July 7, 2014.

ADDRESSES: You may submit comments identified by Federal Docket
Management System Number FMCSA-2013-0470 by any of the following
methods:
     Federal eRulemaking Portal: www.regulations.gov. Follow
the online instructions for submitting comments.
     Fax: 1-202-493-2251.
     Mail: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE, West Building, Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, between 9 a.m. and 5 p.m.
E.T., Monday through Friday, except Federal holidays.
    Instructions: All submissions must include the Agency name and
docket number. For detailed instructions on submitting comments and
additional information on the exemption process, see the Public
Participation heading below. Note that all comments received will be
posted without change to www.regulations.gov, including any personal
information provided. Please see the Privacy Act heading below.
    Docket: For access to the docket to read background documents or
comments received, go to www.regulations.gov, and follow the online
instructions for accessing the dockets, or go to the street address
listed above.
    Privacy Act: Anyone can search the electronic form of comments
received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review a
Privacy Act notice regarding our public dockets in the January 17,
2008, issue of the Federal Register (73 FR 3316).
    Public Participation: The Federal eRulemaking Portal is available
24 hours each day, 365 days each year. You can get electronic
submission and retrieval help and guidelines under the ``help'' section
of the Federal eRulemaking Portal Web site. If you want us to notify
you that we received your comments, please include a self-addressed,
stamped envelope or postcard, or print the acknowledgement page that
appears after submitting comments online. Comments received after the
comment closing date will be included in the docket, and we will
consider late comments to the extent practicable.

FOR FURTHER INFORMATION CONTACT: Mr. Thomas Yager, Chief, FMCSA Driver
and Carrier Operations Division; Office of Carrier, Driver and Vehicle
Safety Standards; Telephone:<PHONE_NUMBER>. Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    FMCSA has authority under 49 U.S.C. 31136(e) and 31315 to grant
exemptions from certain parts of the Federal Motor Carrier Safety
Regulations (FMCSRs) (49

CFR part 350 et seq.). FMCSA must publish a notice of each exemption
request in the Federal Register [49 CFR 381.315(a)]. The Agency must
provide the public an opportunity to inspect the information relevant
to the application, including any safety analyses that have been
conducted. The Agency must also provide an opportunity for public
comment on the request.
    The Agency reviews safety analyses and public comments submitted,
and determines whether granting the exemption would likely achieve a
level of safety equivalent to, or greater than, the level that would be
achieved by the current regulation (49 CFR 381.305). The decision of
the Agency must be published in the Federal Register (49 CFR
381.315(b)) with the reasons for denying or granting the application
and, if granted, the name of the person or class of persons receiving
the exemption, and the regulatory provision from which the exemption is
granted. The notice must also specify the effective period and explain
the terms and conditions of the exemption. The exemption may be renewed
[49 CFR 381.300(b)].

ATA Application for an Exemption

    Part 395 of the FMCSRs contains the hours of service (HOS) rules
for drivers of CMVs in interstate commerce. Section 395.8 of the FMCSRs
requires most interstate CMV drivers to maintain a handwritten or
electronic record of duty status, or log, on a 24-hour grid. They must
record their duty status as either ``off duty,'' ``sleeper berth,''
``on duty/not driving'' or ``on duty/driving.'' Drivers must keep their
log up to date to the most recent change of duty status, and have their
log for the current date and the preceding 7 days on board the CMV.
    Generally, a driver may not record time as ``off duty'' unless he
or she has been relieved of all duty and responsibility for the care
and custody of the CMV, its accessories, and its cargo, and is free to
pursue activities of his or her own choosing. Thus, drivers who are
waiting, whether at a loading dock or at a natural gas or oil well
site, are generally considered to be ``on duty.'' Section 395.3(a)(2)
of the FMCSRs provides that ``a driver may drive only during a period
of 14 consecutive hours after coming on duty following 10 consecutive
hours off duty.'' However, the FMCSRs provide a special exception to
the 14-hour rule for the waiting time of a specific classification of
driver. Section 395.1(d)(2) provides, ``In the case of specially
trained drivers of commercial motor vehicles that are specially
constructed to service oil wells, on-duty time shall not include
waiting time at a natural gas or oil well site'' (waiting-time rule).
These drivers may record such waiting time as off duty time, making
note of the waiting-time rule on their log. Section 395.1(d)(2) also
provides that the waiting time of these drivers ``shall not be included
in calculating the 14-hour period. . . .''
    ATA asks that FMCSA, by a limited 2-year exemption that may be
renewed, permit similar treatment of waiting time at such locations to
drivers ``exclusively engaged in servicing oil and natural gas
extraction sites'' who are able to establish ``a method to adequately
ensure a rest opportunity while waiting.'' ATA suggests that ``trucks
equipped with sleeper berths'' and ``on-site bunking or resting
facilities'' would satisfy the ``rest opportunity'' standard. ATA
believes the proposed exemption would encourage these drivers to obtain
quality rest at extraction sites and would provide an improved standard
for State officials enforcing waiting time requirements.
    FMCSA can only grant an exemption if an FMCSR prevents a motor
carrier from ``implementing more efficient or effective operations that
would maintain a level of safety equivalent to, or greater than, the
level achieved without the exemption'' [381.305(a)]. ATA asserts that
its proposed exemption would maintain or exceed the level of safety of
the current waiting-time rule.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315(b)(4), FMCSA
requests public comment on ATA's application for an exemption from
section 395.1(d)(2) (the waiting-time rule) of the FMCSRs. The Agency
will consider all comments received by close of business on July 7,
2014. Comments will be available for examination in the docket at the
location listed under the ADDRESSES section of this notice. The Agency
will consider to the extent practicable comments received in the public
docket after the closing date of the comment period.

    Issued on: May 16, 2014.
 Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2014-11957 Filed 5-22-14; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 83, Number 104 (Wednesday, May 30, 2018)]
[Notices]
[Pages 24796-24797]
[FR Doc No: 2018-11576]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9978-58-ORD]

EPA Board of Scientific Counselors; Notice of Charter Renewal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Charter Renewal.

-----------------------------------------------------------------------

    Notice is hereby given that the Environmental Protection Agency
(EPA) has determined that, in accordance with the provisions of the
Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2, the EPA Board
of Scientific Counselors (BOSC) is in the public interest and is
necessary in connection with the performance of EPA's duties.
Accordingly, the BOSC will be renewed for an additional two-year
period. The purpose of BOSC is to provide advice and recommendations to
the Administrator regarding science and engineering research, programs
and plans, laboratories, and research management practices. Inquiries
may be directed to Tom Tracy, U.S. EPA, (Mail Code 8104R), 1200
Pennsylvania

Avenue NW, Washington, DC 20460, telephone<PHONE_NUMBER>, or
[email protected].

    Dated: April 5, 2018.
Jennifer Orme-Zavaleta,
Principal Deputy Assistant Administrator for Science for the Office of
Research and Development, EPA Science Advisor.
[FR Doc. 2018-11576 Filed 5-29-18; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: May 9, 2008 (Volume 73, Number 91)]
[Notices]
[Page 26467]
[DOCID:fr09my08-129]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

Sunshine Act Meetings; Unified Carrier Registration Plan Board of
Directors

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

Time and Date:  June 9, 2008, from 1 p.m. until 5 p.m., and June 10,
2008, from 8 a.m. until 12 Noon, Eastern Daylight Time.

Place:  This meeting will take place at The Brown Hotel, 335 West
Broadway, Louisville, Kentucky 40202.

Status:  Open to the public.

Matters To Be Considered:  The Unified Carrier Registration Plan Board
of Directors (the Board) will continue its work in developing and
implementing the Unified Carrier Registration Plan and Agreement and to
that end, may consider matters properly before the Board.

FOR FURTHER INFORMATION CONTACT: Mr. Avelino Gutierrez, Chair, Unified
Carrier Registration Board of Directors at<PHONE_NUMBER>.

    Dated: May 1, 2008.
William A. Quade,
Associate Administrator for Enforcement and Program Delivery.
[FR Doc. 08-1246 Filed 5-7-08; 2:40 pm]

BILLING CODE 4910-EX-P


[Federal Register: October 6, 2006 (Volume 71, Number 194)]
[Notices]
[Page 59102-59103]
[DOCID:fr06oc06-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP06-275-000]

Equitrans, LP; Notice of Availability of the Environmental
Assessment for the Proposed Big Sandy Pipeline Project

September 29, 2006.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission), in cooperation with the United States Army Corps of
Engineers, has prepared an environmental assessment (EA) on the natural
gas pipeline facilities proposed by Equitrans, LP (Equitrans) in the
above-referenced docket.
    The EA was prepared to satisfy the requirements of the National
Environmental Policy Act. The FERC staff concludes that approval of the
proposed project, with appropriate mitigating measures, would not
constitute a major federal action significantly affecting the quality
of the human environment.
    The EA assesses the potential environmental effects of the
construction and operation of Equitrans' proposed Big Sandy Pipeline
Project. The project includes construction of approximately 68 miles of
20-inch-diameter natural gas pipeline and appurtenant facilities in
Carter, Lawrence, Floyd, and Johnson Counties, Kentucky. A compressor
station would also be constructed in Langley, KY.
    The purpose of the project is to provide new firm transportation
capacity of 130,000-dekatherms per day into the interstate natural gas
system to relieve summertime curtailments of natural gas in the eastern
Kentucky basin.
    The EA has been placed in the public files of the FERC. A limited
number of copies of the EA are available for distribution and public
inspection at: Federal Energy Regulatory Commission, Public Reference
Room, 888 First Street, NE., Room 2A, Washington, DC 20426, (202) 502-
8371.
    Copies of the EA have been mailed to federal, state, and local
agencies, public interest groups, interested individuals, newspapers,
and parties to this proceeding.
    Any person wishing to comment on the EA may do so. To ensure
consideration prior to a Commission decision on the proposal, it is
important that we receive your comments before the date specified
below. Please carefully follow these instructions to ensure that your
comments are received in time and properly recorded:

     Send an original and two copies of your comments to:
Magalie R. Salas, Secretary, Federal Energy Regulatory Commission, 888
First St., NE., Room 1A, Washington, DC 20426;
     Reference Docket No. CP06-275-000;
     Label one copy of the comments for the attention of the
Gas Branch 1, PJ-11.1; and
     Mail your comments so that they will be received in
Washington, DC on or before October 30, 2006.
    Please note that the Commission strongly encourages electronic
filing of any comments or interventions or protests to this proceeding.
See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's
Web site at http://www.ferc.gov under the ``e-Filing'' link and the

link to the User's Guide. Before you can file comments you will need to
create an account which can be created on-line.
    Comments will be considered by the Commission but will not serve to
make the commentor a party to the proceeding. Any person seeking to
become a party to the proceeding must file a motion to intervene
pursuant to Rule 214 of the Commission's Rules of Practice and
Procedures (18 CFR 385.214).\1\ Only intervenors have the right to seek
rehearing of the Commission's decision.
---------------------------------------------------------------------------

    \1\ Interventions may also be filed electronically via the
Internet in lieu of paper. See the previous discussion on filing
comments electronically.
---------------------------------------------------------------------------

    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your comments considered.
    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC or on the
FERC Internet Web site (http://www.ferc.gov) using the eLibrary link.

Click on the eLibrary link, click on ``General Search'' and enter the
docket number excluding the last three digits in the Docket Number
field. Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,

contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-16532 Filed 10-5-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 119 (Thursday, June 20, 2019)]
[Notices]
[Pages 28798-28799]
[FR Doc No: 2019-13136]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 14986-000]

Notice of Preliminary Permit Application Accepted for Filing and
Soliciting Comments, Motions To Intervene, and Competing Applications;
California State University Maritime Academy

    On April 17, 2019, the California State University Maritime Academy
(Cal Maritime) filed an application for a preliminary permit, pursuant
to section 4(f) of the Federal Power Act (FPA), proposing to study the
feasibility of the Cal Maritime Marine Hydrokinetic Project (project).
The proposed project would be located in a navigable cove of the
Sacramento San Joaquin River (Carquinez Strait), located in the City of

Vallejo, in Solano County, California. The sole purpose of a
preliminary permit, if issued, is to grant the permit holder priority
to file a license application during the permit term. A preliminary
permit does not authorize the permit holder to perform any land-
disturbing activities or otherwise enter upon lands or waters owned by
others without the owners' express permission.
    The proposed project would consist of a floating power platform
located at Cal Maritime's property and use marine hydrokinetic
technologies to generate approximately 41,610 megawatt hours annually.
The floating platform would measure 120-feet-long by 40-feet-wide, and
14-feet-deep. Cal Maritime proposes to use the power generated by the
project on its campus and distribute the excess power through an
interconnect with Pacific Gas and Electric Company's Colgate-Oakland
transmission line.
    Applicant Contact: Franz Lozano, Vice President & CFO, California
State University Maritime Academy, 200 Maritime Academy, Vallejo, CA
94590; phone:<PHONE_NUMBER>; or via email at<EMAIL_ADDRESS>    FERC Contact: Kenneth Hogan; phone:<PHONE_NUMBER>; or email at:
<EMAIL_ADDRESS>    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Competing applications and notices of intent must meet the requirements
of 18 CFR 4.36.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, notices of intent, and competing
applications using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. The first page of any filing should include
docket number P-14986-000.
    More information about this project, including a copy of the
application, can be viewed or printed on the ``eLibrary'' link of
Commission's website at http://www.ferc.gov/docs-filing/elibrary.asp.
Enter the docket number (P-14986-000) in the docket number field to
access the document. For assistance, contact FERC Online Support.

    Dated: June 14, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-13136 Filed 6-19-19; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 140 (Monday, July 26, 2021)]
[Notices]
[Pages 40069-40071]
[FR Doc No: 2021-15868]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2151]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP). In addition, the FIRM and FIS
report, once effective, will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings.

DATES: Comments are to be submitted on or before October 25, 2021.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective

Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2151, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email<EMAIL_ADDRESS>
FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP and are used to calculate the appropriate
flood insurance premium rates for new buildings built after the FIRM
and FIS report become effective.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where applicable, FIS report for each
community are available for inspection at both the online location
https://hazards.fema.gov/femaportal/prelimdownload and the respective
Community Map Repository address listed in the tables. For communities
with multiple ongoing Preliminary studies, the studies can be
identified by the unique project number and Preliminary FIRM date
listed in the tables. Additionally, the current effective FIRM and FIS
report for each community are accessible online through the FEMA Map
Service Center at https://msc.fema.gov for comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
               Warren County, Ohio and Incorporated Areas
         Project: 14-05-4202S Preliminary Date: February 3, 2021
------------------------------------------------------------------------
City of Lebanon........................  Town Hall, 50 South Broadway,
                                          Lebanon, OH 45036.
City of Mason..........................  Municipal Center, 6000 Mason
                                          Montgomery Road, Mason, OH
                                          45040.
Unincorporated Areas of Warren County..  Warren County Administration
                                          Building, 406 Justice Drive,
                                          Room 167, Lebanon, OH.
Village of Corwin......................  Village of Corwin
                                          Administration Building, 6050
                                          North Clarksville Road,
                                          Waynesville, OH 45068.
Village of Maineville..................  Village of Maineville
                                          Administrative Offices, 8188
                                          South State Route 48,
                                          Maineville, OH 45039.
Village of Morrow......................  Municipal Building, 150 East
                                          Pike Street, Morrow, OH 45152.
Village of South Lebanon...............  Municipal Building, 10 North
                                          High Street, South Lebanon, OH
                                          45065.
Village of Waynesville.................  Municipal Building, 1400 Lytle
                                          Road, Waynesville, OH 45068.
------------------------------------------------------------------------
             Brown County, Wisconsin and Incorporated Areas
        Project: 13-05-2177S Preliminary Date: November 18, 2020
------------------------------------------------------------------------
City of De Pere........................  City Hall, 335 South Broadway,
                                          De Pere, WI 54115.
City of Green Bay......................  City Hall, 100 North Jefferson
                                          Street, Green Bay, WI 54301.
Village of Allouez.....................  Brown County Planning, 305 East
                                          Walnut Street, Room 320, Green
                                          Bay, WI 54301.
Village of Ashwaubenon.................  Village Hall, 2155 Holmgren
                                          Way, Ashwaubenon, WI 54304.
Village of Howard......................  Village Hall, 2456 Glendale
                                          Avenue, Howard, WI 54313.
Village of Suamico.....................  Municipal Services Center,
                                          12781 Velp Avenue, Suamico, WI
                                          54313.
Unincorporated Areas of Brown County...  Brown County Planning, 305 East
                                          Walnut Street, Room 320, Green
                                          Bay, WI 54301.
------------------------------------------------------------------------

[FR Doc. 2021-15868 Filed 7-23-21; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 4 (Tuesday, January 7, 2014)]
[Proposed Rules]
[Pages 765-773]
[FR Doc No: 2014-00027]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2013-N-1518]

Cardiovascular Devices; Reclassification of Nonroller-Type
Cardiopulmonary Bypass Blood Pumps for Cardiopulmonary and Circulatory
Bypass; Effective Date of Requirement for Premarket Approval for
Nonroller-Type Cardiopulmonary Bypass Blood Pumps for Temporary
Ventricular Support

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed order.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed
administrative order to reclassify nonroller-type cardiopulmonary
bypass blood pump devices, when used for cardiopulmonary and
circulatory bypass, a preamendments class III device, into class II
(special controls) and subject to premarket notification based on new
information. FDA is also proposing to require the filing of a premarket
approval application (PMA) or a notice of completion of a product
development protocol (PDP) for nonroller-type cardiopulmonary bypass
blood pump devices for temporary ventricular support. The Agency is
also summarizing its proposed findings regarding the degree of risk of
illness or injury designed to be eliminated or reduced by requiring the
devices to meet the statute's approval requirements when used for
temporary ventricular support. In addition, FDA is announcing the
opportunity for interested persons to request that the Agency change
the classification of any of the devices mentioned in this document
based on new information. This action implements certain statutory
requirements.

DATES: Submit either electronic or written comments on this proposed
order by April 7, 2014. FDA intends that, if a final order based on
this proposed order is issued, anyone who wishes to continue to market
nonroller-type cardiopulmonary bypass blood pump devices for temporary
ventricular support will need to file a PMA or a notice of completion
of a PDP within 90 days of the effective date of the final order. See
section XVII of this document for the proposed effective date of any
final order based on this proposed order.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2013-
N-1518, by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-2013-N-1518 for this rulemaking. All comments
received may be posted without change to http://www.regulations.gov,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
    Docket: For access to the docket to read background documents or
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: Angela Krueger, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (Pub. L. 101-629), the
Food and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L.
105-115), the Medical Device User Fee and Modernization Act of 2002
(Pub. L. 107-250), the Medical Devices Technical Corrections Act (Pub.
L. 108-214), the Food and Drug Administration Amendments Act of 2007
(Pub. L. 110-85), and the Food and Drug Administration Safety and
Innovation Act (FDASIA) (Pub. L. 112-144), establishes a comprehensive
system for the regulation of medical devices intended for human use.
Section 513 of the FD&C Act (21 U.S.C. 360c) established three
categories (classes) of devices, reflecting the regulatory controls
needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
    Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
    Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices), are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and part 807 (21 CFR part 807).
    A preamendments device that has been classified into class III and
devices found substantially equivalent by means of premarket
notification (510(k)) procedures to such a preamendments device or to a
device within that type may be marketed without submission of a PMA
until FDA issues a final order under section 515(b) of the FD&C Act (21
U.S.C. 360e(b)) requiring premarket approval or until the device is
subsequently reclassified into class I or class II.
    Although, under the FD&C Act, the manufacturer of a class III
preamendments device may respond to the call for PMAs by filing a PMA
or a notice of completion of a PDP, in practice, the option of filing a
notice of completion of a PDP has not been used. For simplicity,
although corresponding

requirements for PDPs remain available to manufacturers in response to
a final order under section 515(b) of the FD&C Act, this document will
refer only to the requirement for the filing and receiving approval of
a PMA.
    On July 9, 2012, FDASIA was enacted. Section 608(a) of FDASIA (126
Stat. 1056) amended section 513(e) of the FD&C Act, changing the
process for reclassifying a device from rulemaking to an administrative
order. Section 608(b) of FDASIA (126 Stat. 1056) amended section 515(b)
of the FD&C Act, changing the process for requiring premarket approval
for a preamendments class III device from rulemaking to an
administrative order.

A. Reclassification

    FDA is publishing this document to propose the reclassification of
nonroller-type cardiopulmonary bypass blood pump devices for
cardiopulmonary and circulatory bypass from class III to class II.
    Section 513(e) of the FD&C Act governs reclassification of
classified preamendments devices. This section provides that FDA may,
by administrative order, reclassify a device based upon ``new
information.'' FDA can initiate a reclassification under section 513(e)
of the FD&C Act or an interested person may petition FDA to reclassify
a preamendments device. The term ``new information,'' as used in
section 513(e) of the FD&C Act, includes information developed as a
result of a reevaluation of the data before the Agency when the device
was originally classified, as well as information not presented, not
available, or not developed at that time. (See, e.g., Holland-Rantos
Co. v. United States Department of Health, Education, and Welfare, 587
F.2d 1173, 1174 n.1 (D.C. Cir. 1978); Upjohn v. Finch, 422 F.2d 944
(6th Cir. 1970); Bell v. Goddard, 366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an
appropriate basis for subsequent action where the reevaluation is made
in light of newly available authority (see Bell, 366 F.2d at 181;
Ethicon, Inc. v. FDA, 762 F.Supp. 382, 388-391 (D.D.C. 1991)), or in
light of changes in ``medical science'' (Upjohn, 422 F.2d at 951).
Whether data before the Agency are old or new data, the ``new
information'' to support reclassification under section 513(e) must be
``valid scientific evidence,'' as defined in section 513(a)(3) of the
FD&C Act and Sec.  860.7(c)(2) (21 CFR 860.7(c)(2)). (See, e.g.,
General Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens
Association v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S.
1062 (1986).)
    FDA relies upon ``valid scientific evidence'' in the classification
process to determine the level of regulation for devices. To be
considered in the reclassification process, the ``valid scientific
evidence'' upon which the Agency relies must be publicly available.
Publicly available information excludes trade secret and/or
confidential commercial information, e.g., the contents of a pending
PMA. (See section 520(c) of the FD&C Act (21 U.S.C. 360j(c)).) Section
520(h)(4) of the FD&C Act, added by FDAMA, provides that FDA may use,
for reclassification of a device, certain information in a PMA 6 years
after the application has been approved. This can include information
from clinical and preclinical tests or studies that demonstrate the
safety or effectiveness of the device but does not include descriptions
of methods of manufacture or product composition and other trade
secrets.
    Section 513(e)(1) of the FD&C Act sets forth the process for
issuing a final order for reclassifying a device. Specifically, prior
to the issuance of a final order reclassifying a device, the following
must occur: (1) Publication of a proposed order in the Federal
Register; (2) a meeting of a device classification panel described in
section 513(b) of the FD&C Act; and (3) consideration of comments to a
public docket. FDA has held a meeting of a device classification panel
described in section 513(b) of the FD&C Act with respect to nonroller-
type cardiopulmonary bypass blood pump devices, and therefore, has met
this requirement under section 515(e) of the FD&C Act.
    FDAMA added section 510(m) to the FD&C Act. Section 510(m) of the
FD&C Act provides that a class II device may be exempted from the
premarket notification requirements under section 510(k) of the FD&C
Act, if the Agency determines that premarket notification is not
necessary to assure the safety and effectiveness of the device.

B. Requirement for Premarket Approval Application

    FDA is proposing to require PMAs for nonroller-type cardiopulmonary
bypass blood pump devices for temporary ventricular support.
    Section 515(b)(1) of the FD&C Act sets forth the process for
issuing a final order requiring PMAs. Specifically, prior to the
issuance of a final order requiring premarket approval for a
preamendments class III device, the following must occur: (1)
Publication of a proposed order in the Federal Register; (2) a meeting
of a device classification panel described in section 513(b) of the
FD&C Act; and (3) consideration of comments from all affected
stakeholders, including patients, payors, and providers. The meeting of
the device classification panel described in section 513(b) of the FD&C
Act with respect to nonroller-type cardiopulmonary bypass blood pump
devices satisfies this requirement under section 515(b)(1) of the FD&C
Act.
    Section 515(b)(2) of the FD&C Act provides that a proposed order to
require premarket approval shall contain: (1) The proposed order, (2)
proposed findings with respect to the degree of risk of illness or
injury designed to be eliminated or reduced by requiring the device to
have an approved PMA or a declared completed PDP and the benefit to the
public from the use of the device, (3) an opportunity for the
submission of comments on the proposed order and the proposed findings,
and (4) an opportunity to request a change in the classification of the
device based on new information relevant to the classification of the
device.
    Section 515(b)(3) of the FD&C Act provides that FDA shall, after
the close of the comment period on the proposed order, consideration of
any comments received, and a meeting of a device classification panel
described in section 513(b) of the FD&C Act, issue a final order to
require premarket approval or publish a document terminating the
proceeding together with the reasons for such termination. If FDA
terminates the proceeding, FDA is required to initiate reclassification
of the device under section 513(e) of the FD&C Act, unless the reason
for termination is that the device is a banned device under section 516
of the FD&C Act (21 U.S.C. 360f).
    Under section 501(f) of the FD&C Act (21 U.S.C. 351(f)), a
preamendments class III device may be commercially distributed without
a PMA until 90 days after FDA issues a final order (or a final rule
under section 515(b) of the FD&C Act if issued prior to the enactment
of FDASIA) requiring premarket approval for the device, or 30 months
after final classification of the device under section 513 of the FD&C
Act, whichever is later. For nonroller-type cardiopulmonary bypass
blood pump devices, the preamendments class III devices that are the
subject of this proposal, the later of these two time periods is the
90-day period. Since these devices were classified in 1980, the 30-
month period has expired (45 FR 7959, February 5, 1980). Therefore, if
the proposal to require premarket approval for nonroller-type
cardiopulmonary bypass blood pump devices for

temporary ventricular support is finalized, section 501(f)(2)(B) of the
FD&C Act requires that a PMA for such device be filed within 90 days of
the date of issuance of the final order. If a PMA is not filed for such
devices within 90 days after the issuance of a final order, the device
would be deemed adulterated under section 501(f) of the FD&C Act.
    Also, a preamendments device subject to the order process under
section 515(b) of the FD&C Act is not required to have an approved
investigational device exemption (IDE) (see part 812 (21 CFR part 812))
contemporaneous with its interstate distribution until the date
identified by FDA in the final order requiring the filing of a PMA for
the device. At that time, an IDE is required only if a PMA has not been
filed. If the manufacturer, importer, or other sponsor of the device
submits an IDE application and FDA approves it, the device may be
distributed for investigational use. If a PMA is not filed by the later
of the two dates, and the device is not distributed for investigational
use under an IDE, the device is deemed to be adulterated within the
meaning of section 501(f)(1)(A) of the FD&C Act, and subject to seizure
and condemnation under section 304 of the FD&C Act (21 U.S.C. 334) if
its distribution continues. Other enforcement actions include, but are
not limited to, the following: Shipment of devices in interstate
commerce will be subject to injunction under section 302 of the FD&C
Act (21 U.S.C. 332), and the individuals responsible for such shipment
will be subject to prosecution under section 303 of the FD&C Act (21
U.S.C. 333). In the past, FDA has requested that manufacturers take
action to prevent the further use of devices for which no PMA has been
filed and may determine that such a request is appropriate for the
class III devices that are the subject of this proposed order, if
finalized.
    In accordance with section 515(b) of the FD&C Act, interested
persons are being offered the opportunity to request reclassification
of nonroller-type cardiopulmonary bypass blood pump devices for
temporary ventricular support.

II. Device Description

    A nonroller-type blood pump, also referred to as a nonroller-pump
(NRP), is a prescription device that uses a method other than revolving
rollers to pump blood. While the technologies utilized by NRPs which
have been reviewed by the Agency to date include: (1) Centrifugal pumps
and (2) catheter-based axial pumps, additional methods for blood
propulsion can be anticipated in future devices.
    To further delineate types of NRP devices and their intended uses,
FDA proposes to rename the devices in this regulation for purposes of
consistency and clarity. The term ``NRP Devices for Temporary
Cardiopulmonary Bypass'' will be used to designate blood pumps that use
nonroller pump technology temporarily (i.e. <6 hours) to propel blood
through a cardiopulmonary bypass circuit. The term ``NRP Devices for
Temporary Circulatory Bypass'' will be used to designate blood pumps
that utilize nonroller pump technology to provide temporary (i.e. <6
hours) circulatory bypass around a planned surgical disruption of the
arterial and venous great vessels (i.e. aorta and vena cavae). The term
``NRP Devices for Temporary Ventricular Support'' will be used to
designate blood pumps that use nonroller pump technology (e.g. axial or
centrifugal flow pumps) to provide temporary (i.e. <6 hours) support of
ventricular function resulting from ongoing or anticipated episodes of
immediately reversible myocardial dysfunction.

A. NRP Devices for Temporary Cardiopulmonary and Circulatory Bypass

    NRP devices in current use for temporary cardiopulmonary and
circulatory bypass rely primarily upon centrifugal pump technology that
utilizes a rotor to impart energy to the blood in an extracorporeal
circuit through centrifugal forces. These pumps house an impeller,
magnet, and housing bottom that fit into a drive unit. The motor drive
unit holds the disposable blood pump and drives the rotor inside the
blood pump with a magnet. These types of pumps have been used as part
of an extracorporeal circuit, external to the body and in combination
with an oxygenator, to provide cardiopulmonary support for periods
lasting less than 6 hours. Additionally, centrifugal pumps can be used
in isolation, external to the body but without an oxygenator, to
provide temporary circulatory bypass around a planned disruption of the
circulatory pathway necessary for open surgical procedures on the aorta
or vena cava. Although all currently available devices rely on
centrifugal forces to propel blood through these circuits, additional
methods for blood propulsion can be anticipated in future devices. For
all these future devices, the technology to propel blood as or more
efficiently (i.e. adequate volume and with minimal trauma) compared
with current technology will be essential in the evaluation for
marketing authorization.

B. NRP Devices for Temporary Ventricular Support

    NRP devices that pump blood for the purpose of full or partial
temporary (i.e. <6 hours) ventricular support may be divided into two
broad categories: (1) Those where the temporary NRP device resides
within the circulation, and 2) those where the temporary NRP device
resides outside the circulation. NRP devices used for temporary
ventricular support also typically require percutaneous placement of
either catheters (which contain the pump device), or access cannulae.
Either or both of these may be required to reside in and/or traverse
one or more elements of the circulation (great vessels, valves, septa).
Examples include catheter-based microaxial-type pumps comprising a pump
motor, cannula, and catheter that connect to a console. Catheter-based
microaxial-type pumps are not currently designed to be used with an
oxygenator but are temporarily implanted within the heart or
vasculature to provide cardiac support by supplementing the function of
one or both ventricles, restoring forward flow, and/or allowing the
ventricle to rest and repair by decreasing the work and energy demands
secondary to ventricular unloading. Centrifugal pump circuits, where
the NRP resides outside of the body, have also been used for this
purpose following percutaneous placement of inflow and outflow cannulas
into the appropriate chambers and vessels. Future development of other
pump and cannula technologies to be used for the purpose of temporary
ventricular support is anticipated.

III. Regulatory History of the Device

    As discussed in the preamble to the proposed rule to classify these
devices into class III (44 FR 13409, March 9, 1979), the Cardiovascular
Device Classification Panel (the 1979 Panel) recommended that
nonroller-type cardiopulmonary bypass blood pumps be classified into
class III because the device is life supporting and is potentially
hazardous to life or health even when properly used. The 1979 Panel
noted that the device is attached directly to the cardiopulmonary
bypass circuit and is used in a clinical environment where excessive
leakage current can be a serious hazard. The 1979 Panel further noted
that the device is used with other devices in a system that may be
hazardous if not satisfactorily assembled, used, or maintained. The
1979 Panel indicated that general controls alone would not

provide sufficient control over the performance characteristics of the
device. Additionally, a performance standard would not provide
reasonable assurance of the safety and effectiveness of the device; the
Panel noted further that there was not sufficient information to
establish a standard to provide such assurance. Consequently, the 1979
Panel believed that premarket approval was necessary to assure the
safety and effectiveness of the device. In 1980, FDA classified
nonroller-type cardiopulmonary bypass blood pumps into class III after
receiving no comments on the proposed rule (45 FR 7959, February 5,
1980).
    In 1987, FDA published a clarification by inserting language in the
codified language stating that no effective date had been established
for the requirement for premarket approval for nonroller-type
cardiopulmonary bypass blood pumps (52 FR 17732, May 11, 1987).
    On July 6, 1993, FDA published a proposed rule to establish an
effective date of requirement for premarket approval (i.e. call for
PMAs) for nonroller-type cardiopulmonary bypass blood pumps, and
provided an opportunity to request a change in classification in the
form of a reclassification petition (58 FR 36290). On July 21, 1993,
FDA received a reclassification petition from manufacturers of these
devices recommending reclassification to class II (special controls).
On August 21, 1995, FDA convened the Circulatory System Devices
Classification Panel (the 1995 Panel) to review the proposed
reclassification and proposed special controls for nonroller-type
cardiopulmonary blood pumps for use in cardiopulmonary bypass circuits
for periods of up to 6 hours. Reclassification to class II with special
controls was supported by the 1995 Panel for nonroller-type
cardiopulmonary blood pumps for use in cardiopulmonary bypass circuits
for periods of up to 6 hours. FDA did not issue a final regulation
codifying the proposed reclassification. In 2004, the July 6, 1993,
proposed rule (58 FR 36290) was withdrawn because the proposed rule was
no longer considered a viable candidate for final action, due to the
length of time that had elapsed since the proposed rule was issued (69
FR 68831, November 26, 2004).
    In 2009, FDA published an order for the submission of information
on nonroller-type cardiopulmonary bypass blood pumps by August 7, 2009
(74 FR 16214, April 9, 2009). FDA received seven responses to that
order from device manufacturers. All manufacturers recommended that
nonroller-type cardiopulmonary bypass blood pumps be reclassified to
class II. The manufacturers stated that data available in the clinical
literature, preclinical and clinical testing, additional knowledge and
information regarding the clinical use of the devices, and the overall
number of marketed devices provide reasonable assurance of safety and
effectiveness of these devices.
    As explained further in sections VII and XI of this document, a
meeting of the Circulatory System Devices Panel (the 2012 Panel) took
place December 6, 2012, to discuss whether nonroller-type
cardiopulmonary bypass blood pump devices should be reclassified or
remain in class III. The 2012 Panel recommended that nonroller-type
cardiopulmonary bypass blood pump devices for cardiopulmonary and
circulatory bypass be reclassified to class II with special controls,
and nonroller-type cardiopulmonary bypass blood pump devices for
temporary ventricular support remain in class III because the device is
life-supporting and there was insufficient information to establish
special controls for this use. FDA is not aware of new information that
would provide a basis for a different recommendation or findings.

IV. Proposed Reclassification

    FDA is proposing that NRP devices used to propel blood within
temporary (i.e. less than 6 hours) extracorporeal cardiopulmonary and
circulatory bypass circuits be reclassified from class III to class II.
In this proposed order, the Agency has identified special controls
under section 513(a)(1)(B) of the FD&C Act that, together with general
controls applicable to the devices, would provide reasonable assurance
of their safety and effectiveness. Absent the special controls
identified in this proposed order, general controls applicable to the
device are insufficient to provide reasonable assurance of the safety
and effectiveness of the device.
    Therefore, in accordance with sections 513(e) and 515(i) of the
FD&C Act and 21 CFR 860.130, based on new information with respect to
the devices, and taking into account the public health benefit of the
use of the device and the nature and known incidence of the risk of the
device, FDA, on its own initiative, is proposing to reclassify NRP
Devices for Temporary Cardiopulmonary and Circulatory Bypass into class
II. FDA believes that this new information is sufficient to demonstrate
that the proposed special controls can effectively mitigate the risks
to health identified in the next section, and that these special
controls, together with general controls, will provide a reasonable
assurance of safety and effectiveness for NRP Devices for Temporary
Cardiopulmonary and Circulatory Bypass.
    Section 510(m) of the FD&C Act authorizes the Agency to exempt
class II devices from premarket notification (510(k)) submission. FDA
has considered NRP Devices for Temporary Cardiopulmonary and
Circulatory Bypass in accordance with the reserved criteria set forth
in section 513(a) of the FD&C Act and decided that the device does
require premarket notification. Therefore, the Agency does not intend
to exempt this proposed class II device from premarket notification
(510(k)) submission.
    Because NRP Devices for Temporary Cardiopulmonary and Circulatory
Bypass can currently be marketed after receiving clearance of an
application for premarket notification, and FDA is proposing to
reclassify these devices as class II requiring clearance of an
application for premarket notification, this order, if finalized, will
not require a new premarket submission for NRP Devices for Temporary
Cardiopulmonary and Circulatory Bypass.

V. Risks to Health

    After considering available information, including the
recommendations of the advisory committees (panels) for the
classification of these devices, FDA has evaluated the risks to health
associated with the use of NRP Devices for Temporary Cardiopulmonary
and Circulatory Bypass and determined that the following risks to
health are associated with their use:
     Alteration in blood composition: It is essential that the
flow characteristics, heat generated by the pump within the
extracorporeal circuit, materials, surface finish, and/or cleanliness
of the device do not promote blood component trauma. Resulting
complications could include bleeding, hemolysis, thrombus formation,
and/or complement activation. Improper mechanical design of the device
can also result in such complications.
     Inadequate tissue perfusion: If the design of the pump is
improper, or the pump is unable to pump blood adequately through a
cardiopulmonary bypass circuit, inadequate organ perfusion can result.
Limb ischemia, access vessel injury, or dissection resulting in
ischemia can result from peripheral cardiopulmonary bypass access.
     Embolism: Improper design of the device may cause the
generation of

gaseous, particular, or thrombotic emboli, which can result in
debilitating or fatal complications such as stroke, peripheral emboli,
or death.
     Use beyond intended duration: Use of the pump beyond the
intended duration can result in more frequent and severe adverse
effects.
     Fluid leakage: If the structural integrity of the pump is
compromised, fluid leakage may result.
     Adverse tissue reaction: Inadequate compatibility of the
patient-contacting materials of the device may cause physical damage to
the blood components, or may cause an adverse immunological or allergic
reaction in a patient.
     Infection: Defects in the design or construction of the
device preventing adequate cleaning and/or sterilization can allow
pathogenic organisms to be introduced and can cause an infection in a
patient.

VI. Summary of Reasons for Reclassification

    If properly manufactured and used as intended, NRP Devices for
Temporary Cardiopulmonary and Circulatory Bypass can provide a
treatment option for patients when used for cardiopulmonary bypass by
providing propulsion of blood through cardiopulmonary bypass circuits
or when used for circulatory bypass by allowing planned surgical
disruptions of the circulation to avoid distal organ ischemia or venous
hypertension. FDA believes NRP Devices for Temporary Cardiopulmonary
and Circulatory Bypass should be reclassified from class III to class
II because special controls, in addition to general controls, can be
established to provide reasonable assurance of the safety and
effectiveness of the device, and because general controls themselves
are insufficient to provide reasonable assurance of its safety and
effectiveness. In addition, there is now adequate effectiveness
information sufficient to establish special controls to provide such
assurance. FDA believes that the risks to health identified in section
V associated with NRP Devices for Temporary Cardiopulmonary and
Circulatory Bypass can be mitigated with general and special controls.
FDA has identified the risks to health in the table that follows, and
the special controls to mitigate these identified risks.

------------------------------------------------------------------------
            Identified risk                    Mitigation measures
------------------------------------------------------------------------
Alteration in Blood Composition........  Nonclinical Performance/Bench
                                          Testing Labeling.
Inadequate Tissue Perfusion............  Nonclinical Performance/Bench
                                          Testing Labeling.
Embolism...............................  Nonclinical Performance/Bench
                                          Testing Labeling.
Duration of Use........................  Labeling.
Fluid Leakage..........................  Nonclinical Performance/Bench
                                          Testing.
Adverse Tissue Reaction................  Biocompatibility.
Infection..............................  Sterility and Shelf-Life
                                          Testing.
------------------------------------------------------------------------

VII. Summary of Data Upon Which the Reclassification Is Based

    Since the time of the 1979 Panel recommendation, sufficient
evidence has been developed to support a reclassification of NRP
Devices for Temporary Cardiopulmonary and Circulatory Bypass to class
II with special controls. FDA has been reviewing these devices for many
years and their risks are well known. FDA conducted a comprehensive
review of available literature for NRP Devices for Temporary
Cardiopulmonary and Circulatory Bypass. FDA's review found 18 studies,
including 1 randomized controlled study (RCT), 1 meta-analysis, 4
cohort studies, and 12 case studies, which provided consistent evidence
of the safety and effectiveness of NRP Devices for Temporary
Cardiopulmonary Bypass. Further, FDA's review found 23 studies related
to NRP Devices for Temporary Circulatory Bypass, including studies
related to both venovenous bypass and aortic procedures, which provided
consistent evidence of the safety and effectiveness of NRP Devices for
Temporary Circulatory Bypass.
    The literature data support that the overall complication rates for
NRP Devices for Temporary Cardiopulmonary Bypass is similar to that of
another class II device type, roller-type cardiopulmonary bypass blood
pumps (21 CFR 870.4370). For example, a meta-analysis of 18 RCTs by
Saczkowski et al. obtained pooled estimates for a number of clinical
outcome measures (Ref. 1). This meta-analysis represented 1,868 adult
patients undergoing cardiopulmonary bypass using either a roller pump
(907) or a centrifugal pump (961), undergoing predominantly coronary
bypass graft surgery (87 percent and 88 percent, respectively).
Patients that underwent a cardiopulmonary bypass procedure either using
NRPs or roller pumps had no differences in mortality (n = 1,080, odds
ratio (OR): 1.05, 95 percent confidence interval (CI): 0.58, 1.88),
bleeding (mean difference: -10.26 mL, 95 percent CI: -54.28, 33.75),
and blood transfusion (OR: 1.11, 95 percent CI: 0.64, 1.92) at the end
of cardiopulmonary bypass or 1 day after the procedure. Similarly, no
statistically significant differences were found on other safety
endpoints reported (postoperative atrial fibrillation, cerebral damage,
platelet count, hemoglobin, white blood cell count, hematocrit,
intensive care unit length of stay, hospital length of stay, and
neurologic outcomes). Additionally, Parolari et al. published a cohort
study of 4,000 patients that demonstrated that patients that had
cardiopulmonary bypass with either a centrifugal pump or a roller pump
had the same in-hospital mortality (2 percent) (Ref. 2). Multivariate
results showed that patients who underwent cardiopulmonary bypass with
the centrifugal pump had a reduction in perioperative permanent
neurological deficit and perioperative coma of 43 percent and 54
percent, respectively, compared to those patients that had a circuit
utilizing a roller pump (p < 0.05).
    The literature data also support the effectiveness of NRP Devices
for Temporary Cardiopulmonary Bypass. Based on FDA's analysis, the most
common indicators of effectiveness were length of stay at the hospital,
length of stay in the intensive care unit (ICU), and duration of
intubation. In Saczkowski's meta-analysis (Ref. 1), no statistically
significant differences were found between the NRPs and roller pumps'
pooled estimates in intensive care unit length of stay and hospital
length of stay. Intubation time among these patients ranged from 8
hours to more than 1 day. Similarly, Zirbel et al. did not find
significant differences in a small cohort study in the hospital and ICU
length of stay and intubation time among patients on cardiopulmonary
bypass with a selected centrifugal pump as compared to those on a
roller pump (Ref. 3).
    The safety and effectiveness of NRPs Devices for Temporary
Circulatory Bypass during surgical procedures on

the descending thoracic or thoracoabdominal aorta have been reported by
numerous authors (Refs. 4-9). These devices have supplanted the use of
passive shunts (e.g., Gott shunt) due to their ability to provide more
reliable and controllable flow to the distal aorta and the organs it
perfuses during planned proximal surgical disruptions. In general,
centrifugal pumps used for temporary circulatory bypass in these
procedures have provided additional margins of safety by allowing for
completion of these procedures in a less rushed fashion and without
full cardiopulmonary bypass (and full heparinization). Additionally,
use of NRPs has been shown to decrease the incidence of distal organ
malperfusion and paraplegia, especially during prolonged cross-clamp
intervals (>30-45 minutes) and reduce transfusion requirements. Use of
NRPs for circulatory bypass has not been associated with significant
adverse events related to the centrifugal pump such as thrombosis,
thromboembolism, or cannulation-related injuries.
    The literature data outlined in this document support a conclusion
of reasonable evidence for the safety and effectiveness of
cardiopulmonary and circulatory bypass blood pump devices. In addition,
bench studies designed to demonstrate the devices' ability to function
as intended have been well characterized.
    FDA's presentation to the 2012 Panel included a summary of the
available safety and effectiveness information for NRP Devices for
Temporary Cardiopulmonary and Circulatory Bypass, including identified
risks to health drawn from adverse event reports from FDA's
Manufacturer and User Facility Device Experience (MAUDE) database and
available literature. Based on the available scientific literature,
which supports that use of NRP Devices for Temporary Cardiopulmonary
and Circulatory Bypass may be beneficial for patients requiring
cardiopulmonary or circulatory bypass, FDA recommended to the 2012
Panel that NRP Devices for Temporary Cardiopulmonary and Circulatory
Bypass be reclassified to class II (special controls). The 2012 Panel
agreed with FDA's conclusion that the available scientific evidence is
adequate to support the safety and effectiveness of NRP Devices for
Temporary Cardiopulmonary and Circulatory Bypass.
    The 2012 Panel also acknowledged that NRP Devices for Temporary
Cardiopulmonary and Circulatory Bypass are life-supporting devices and
provided the following rationale for recommending that NRP Devices for
Temporary Cardiopulmonary and Circulatory Bypass be reclassified to
class II: (1) The available scientific evidence supports an adequate
assurance of safety and effectiveness for the device; (2) there is
evidence that the device provides hemodynamic support; and (3) the
recommended special controls will mitigate the health risks associated
with the device.
    The 2012 Panel agreed with the identified risks to health presented
at the meeting but also recommended that limb ischemia, access vessel
injury, and dissection resulting in ischemia related to cardiopulmonary
bypass access be considered in the risks to health. FDA agrees with the
2012 Panel's recommendation and modified the risks to health
accordingly as outlined in section V of this document. Specifically,
the definition of ``inadequate tissue perfusion'' was expanded to
include these events. The 2012 Panel also agreed with FDA's proposed
special controls outlined in section VIII of this document. The 2012
Panel transcript and other meeting materials are available on FDA's Web
site (Ref. 10).

VIII. Proposed Special Controls

    FDA believes that the following special controls, together with
general controls, are sufficient to mitigate the risks to health
described in section V of this document:
    1. Nonclinical performance testing must provide a reasonable
assurance of safety and effectiveness with respect to the operating
parameters, dynamic blood damage, heat generation, air entrapment,
mechanical integrity, and durability/reliability to perform as intended
over the intended duration of use;
    2. The device must be demonstrated to be biocompatible;
    3. Sterility and shelf-life testing must demonstrate the sterility
of patient-contacting components and the shelf-life of these
components; and
    4. Labeling must include information regarding the duration of use
and a detailed summary of the device- and procedure-related
complications pertinent to use of the device.
    NRP Devices for Temporary Cardiopulmonary and Circulatory Bypass
are prescription devices restricted to patient use only upon the
authorization of a practitioner licensed by law to administer or use
the device. (Proposed 21 CFR 870.4360(a)(1); see 21 CFR 801.109
(Prescription devices)).

IX. Dates New Requirements Apply

    In accordance with section 515(b) of the FD&C Act, FDA is proposing
to require that a PMA be filed with the Agency for NRP Devices for
Temporary Ventricular Support within 90 days after issuance of any
final order based on this proposal. An applicant whose device was
legally in commercial distribution before May 28, 1976, or whose device
has been found to be substantially equivalent to such a device, will be
permitted to continue marketing such class III devices during FDA's
review of the PMA provided that the PMA is timely filed. FDA intends to
review any PMA for the device within 180 days of the date of filing.
FDA cautions that under section 515(d)(1)(B)(i) of the FD&C Act, the
Agency may not enter into an agreement to extend the review period for
a PMA beyond 180 days unless the Agency finds that ``the continued
availability of the device is necessary for the public health.''
    An applicant whose device was legally in commercial distribution
before May 28, 1976, or whose device has been found to be substantially
equivalent to such a device, who does not intend to market such device
for temporary ventricular support, and for which the device technology
would allow such device to be used for cardiopulmonary or circulatory
bypass, may remove such intended use from the device's labeling by
initiating a correction within 90 days after issuance of any final
order based on this proposal. Under 21 CFR part 806.10(a)(2) a device
manufacturer or importer initiating a correction to remedy a violation
of the FD&C Act that may present a risk to health is required to submit
a written report of the correction to FDA.
    FDA intends that under Sec.  812.2(d), the preamble to any final
order based on this proposal will state that, as of the date on which
the filing of a PMA is required to be filed, the exemptions from the
requirements of the IDE regulations for preamendments class III devices
in Sec.  812.2(c)(1) and (c)(2) will cease to apply to any device that
is: (1) Not legally on the market on or before that date or (2) legally
on the market on or before that date but for which a PMA is not filed
by that date, or for which PMA approval has been denied or withdrawn.
    If a PMA for a class III device is not filed with FDA within 90
days after the date of issuance of any final order requiring premarket
approval for the device, the device would be deemed adulterated under
section 501(f) of the FD&C Act. The device may be distributed for
investigational use only if the requirements of the IDE regulations are
met. The requirements for significant risk devices include submitting
an IDE application to FDA

for review and approval. An approved IDE is required to be in effect
before an investigation of the device may be initiated or continued
under Sec.  812.30. FDA, therefore, recommends that IDE applications be
submitted to FDA at least 30 days before the end of the 90-day period
after the issuance of the final order to avoid interrupting any ongoing
investigations.

X. Proposed Findings With Respect to Risks and Benefits

    As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that this
device have an approved PMA when used for temporary ventricular
support, and (2) the benefits to the public from the use of NRP Devices
for Temporary Ventricular Support. These findings are based on the
reports and recommendations of the advisory committees (panels) for the
classification of these devices along with information submitted in
response to the 515(i) Order (74 FR 16214, April 9, 2009), and any
additional information that FDA has obtained. Additional information
regarding the risks as well as classification associated with this
device type is discussed in Section XI of this order and can be found
in 44 FR 13409, March 9, 1979; 45 FR 7959, February 5, 1980; 52 FR
17732, May 11, 1987; 58 FR 36290, July 6, 1993; and 69 FR 68831,
November 26, 2004.

XI. Device Subject to the Proposal To Require a PMA--Nonroller-Type
Temporary Ventricular Support Blood Pump Devices (21 CFR 870.4360(c))

A. Identification

    An NRP Device for Temporary Ventricular Support is a prescription
device that uses any method resulting in blood propulsion to provide
the temporary (i.e. <= 6 hours) ventricular assistance required for
support of the systemic and/or pulmonary circulations during periods
when there is ongoing or anticipated hemodynamic instability due to
immediately reversible alterations in ventricular myocardial function
resulting from mechanical or physiologic causes.

B. Summary of Data

    The use of NRP Devices for Temporary Ventricular Support does not
share the long history of use compared to NRP Devices for Temporary
Cardiopulmonary or Circulatory Bypass. Temporary NRP devices, when used
for cardiopulmonary or circulatory bypass, are integral to the
underlying procedure (e.g., open heart surgery, resection of thoracic
aneurysm) itself, making it both possible and safer. When used for
temporary ventricular support, the NRP devices introduce the risk of
both the blood pump and its access technology in procedures where a
substantial portion of patient benefit is derived or thought to be
derived from the avoidance of circulatory support or bypass, or from
the safer performance of the underlying procedure (e.g., percutaneous
coronary intervention, off pump coronary artery bypass). Based on FDA's
review of available data, use of the device is associated with
significant procedural risks. These risks do not appear to be balanced
by a demonstrable clinical benefit. Specifically, based on FDA's review
of the published literature, it appears that there are no completed
studies regarding use of NRP devices that support the effectiveness for
temporary ventricular support. Further, the 2011 American College of
Cardiology Foundation/American Heart Association/Society for
Cardiovascular Angiography and Interventions (ACCF/AHA/SCAI) Guideline
for Percutaneous Coronary Intervention assigned a class IIb, Level C
recommendation to the use of temporary ventricular support devices for
high-risk percutaneous coronary interventions. A Class IIb, level C
indication means that the benefit may outweigh the risk and that the
treatment or procedure may be considered. This recommendation's
usefulness or efficacy is unknown/unclear/uncertain or not well
established and is based only on diverging expert opinion, case
studies, or standard of care (Ref. 11). When used for temporary
ventricular support, FDA concludes that the safety and effectiveness of
NRP devices have not been established by adequate scientific evidence.
The benefit/risk profile for NRP Devices for Temporary Ventricular
Support indications is unknown. Further, safe and effective performance
parameters for the class of devices have not been established by data.
For these reasons, FDA does not believe sufficient information exists
to establish special controls to provide a reasonable assurance of
safety and effectiveness for the devices.
    FDA presented findings regarding NRP Devices for Temporary
Ventricular Support to the Circulatory System Devices Panel (the Panel)
on December 6, 2012. The Panel recommended that available scientific
evidence is not adequate to support the safety and effectiveness of NRP
Devices Temporary Ventricular Support and that these devices fit the
criteria necessary to remain in class III because (1) the devices are
life-supporting and (2) insufficient information exists to determine
that special controls would provide reasonable assurance of its safety
and effectiveness for this use. As a result, the Panel concluded that
NRP Devices for Temporary Ventricular Support should remain in class
III (subject to premarket approval application). The Panel transcript
and other meeting materials are available on FDA's Web site (Ref. 11).

C. Risks to Health

    The risks to health for NRP Devices for Temporary Ventricular
Support include the risks outlined in section V as well as the
following additional risks to health:
     Structural/tissue damage: Improper design, placement, or
use of the percutaneous device or access cannulae can cause structural
or tissue damage to the heart or access vessels, including perforation,
dissection, tamponade, and/or valve damage.
     Intracardiac heat generation: Improper design of the
device may cause excessive heat generation within the heart or great
vessels, which can cause tissue damage and can affect hemolysis and
thromboembolic potential.
     Modified flow dynamics: Improper design or placement of
the percutaneous device or cannulae can cause new or different patterns
or methods of flow, which can affect hemolysis or thromboembolic
potential, or can cause limb ischemia due to the need for peripheral
cannulation with large bore cannulae.
    These additional risks to health are directly related to the NRP
technology that, for temporary use, requires percutaneous placement of
either a pump containing catheter or separate inflow and outflow
cannulae into the heart or great vessels. For effective use, these pump
containing catheters or access cannulae must either reside in and/or
traverse one or more elements of the circulation (i.e. great vessels,
valves, septa). In contrast, temporary NRP devices that are used as
part of an extracorporeal cardiopulmonary bypass or circulatory bypass
circuit do not present these risks to health since the actual NRP
resides outside of the circulation, and the cannulae required for
inflow and outflow are placed under direct visualization into the
central circulation during an open surgical procedure without being
required to traverse one or more cardiac chambers, septa, or valves for
effective use.

D. Benefits of NRP Devices for Temporary Ventricular Support

    As discussed previously, there is limited scientific evidence
regarding the effectiveness of NRP Devices for Temporary Ventricular
Support. Because the benefits of NRP Devices for Temporary Ventricular
Support are unknown, it is impossible to estimate the direct effect of
the devices on patient outcomes. However, NRP Devices for Temporary
Ventricular Support have the potential to benefit the public by
providing cardiac support, improving hemodynamic stability, reducing
myocardial workload and oxygen consumption, and increasing cardiac
output. Their use may also allow initiation or completion of complex
therapies, recovery of native ventricular function sufficient for
weaning of the device, or bridging to more permanent therapies meant to
provide long-term hemodynamic support.

XII. PMA Requirements

    A PMA for NRP Devices for Temporary Ventricular Support must
include the information required by section 515(c)(1) of the FD&C Act
and include all data and information on: (1) Any risks known, or that
should be reasonably known, to the applicant that have not been
identified in this document; (2) the effectiveness of the device that
is the subject of the application; and (3) full reports of all
preclinical and clinical information from investigations on the safety
and effectiveness of the device for which premarket approval is sought.
    A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (see Sec.  860.7(c)(1)). In particular, a PMA for the
device should discuss the benefits of the device in light of the risks
identified in this document. Valid scientific evidence is ``evidence
from well-controlled investigations, partially controlled studies,
studies and objective trials without matched controls, well-documented
case histories conducted by qualified experts, and reports of
significant human experience with a marketed device, from which it can
fairly and responsibly be concluded by qualified experts that there is
reasonable assurance of the safety and effectiveness of a device under
its conditions of use. . . . Isolated case reports, random experience,
reports lacking sufficient details to permit scientific evaluation, and
unsubstantiated opinions are not regarded as valid scientific evidence
to show safety or effectiveness.'' (See Sec.  860.7(c)(2)).

XIII. Opportunity To Request a Change in Classification

    Before requiring the filing of a PMA for a device, FDA is required
by section 515(b)(2)(D) of the FD&C Act to provide an opportunity for
interested persons to request a change in the classification of the
device based on new information relevant to the classification. Any
proceeding to reclassify the device will be under the authority of
section 513(e) of the FD&C Act.
    A request for a change in the classification of NRP Devices for
Temporary Ventricular Support is to be in the form of a
reclassification petition containing the information required by 21 CFR
860.123, including new information relevant to the classification of
the device.

XIV. Codification of Orders

    Prior to the amendments by FDASIA, section 513(e) of the FD&C Act
provided for FDA to issue regulations to reclassify devices and section
515(b) of the FD&C Act provided for FDA to issue regulations to require
approval of an application for premarket approval for preamendments
devices or devices found to be substantially equivalent to
preamendments devices. Because sections 513(e) and 515(b) as amended
require FDA to issue final orders rather than regulations, FDA will
continue to codify reclassifications and requirements for approval of
an application for premarket approval, resulting from changes issued in
final orders, in the Code of Federal Regulations (CFR). Therefore,
under section 513(e)(1)(A)(i) of the FD&C Act, as amended by FDASIA, in
this proposed order, we are proposing to revoke the requirements in 21
CFR 870.4360 related to the classification of nonroller-type
cardiopulmonary bypass blood pump devices as class III devices and to
codify the reclassification of nonroller-type cardiopulmonary and
circulatory bypass blood pump devices into class II.

XV. Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

XVI. Paperwork Reduction Act of 1995

    This proposed order refers to collections of information that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231. The collections of information in part
807, subpart E, have been approved under OMB control number 0910-0120.
The effect of this order, if finalized, is to shift certain devices
from the 510(k) premarket notification process to the PMA process. To
account for this change, FDA intends to transfer some of the burden
from OMB control number 0910-0120, which is the control number for the
510(k) premarket notification process, to OMB control number 0910-0231,
which is the control number for the PMA process. As noted previously,
FDA estimates that it will receive three new PMAs as a result of this
order, if finalized. Based on FDA's most recent estimates, this will
result in 1,038 hours burden increase to OMB control number 0910-0231.
FDA also estimates that there will be three fewer 510(k) submissions as
a result of this order, if finalized. Based on FDA's most recent
estimates, this will result in a 136 hours burden decrease to OMB
control number 0910-0120. Therefore, on net, FDA expects a burden hour
increase of 901 hours due to this proposed regulatory change.

XVII. Proposed Effective Date

    FDA is proposing that any final order based on this proposed order
become effective 90 days after date of publication of the final order
in the Federal Register.

XVIII. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
submit one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

XIX. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site address in this reference

section, but FDA is not responsible for any subsequent changes to the
Web site after this document publishes in the Federal Register.)

1. Saczkowski, R., M. Maklin, T. Mesana, et al., ``Centrifugal Pump
and Roller Pump in Adult Cardiac Surgery: A Meta-Analysis of
Randomized Controlled Trials,'' Artificial Organs, vol. 36, pp. 668-
676, 2012.
2. Parolari, A., F. Alamanni, M. Naliato, et al., ``Adult Cardiac
Surgery Outcomes: Role of the Pump Type,'' European Journal of
Cardiothoracic Surgery, vol. 18, pp. 575-582, 2000.
3. Zirbel, G.M., M.E. Letson, J.N. Kauffman, et al., ``Hematologic
Derangements of Cardiopulmonary Bypass: A Comparison of Two
Perfusion Systems,'' The Journal of Extra-Corporeal Technology, vol.
22, pp. 15-19, 1990.
4. Schepens, M.A., F.E. Vermeulen, W.J. Morshuis, et al., ``Impact
of Left Heart Bypass on the Results of Thoracoabdominal Aortic
Aneurysm Repair,'' The Annals of Thoracic Surgery, vol. 67, pp.
1963-1967; discussion pp. 1979-1980, 1999.
5. Szwerc, M.F., D.H. Benckart, J.C. Lin, et al., ``Recent Clinical
Experience With Left Heart Bypass Using a Centrifugal Pump for
Repair of Traumatic Aortic Transection,'' Annals of Surgery, vol.
230, pp. 484-490; discussion pp. 490-492, 1999.
6. Ataka, K., M. Okada, C. Yamashita, et al., ``Beneficial
Circulatory Support by Left Heart Bypass With a Centrifugal
(BioMedicus) Pump for Aneurysms of the Descending Thoracic Aorta,''
Artificial Organs, vol. 17, pp. 300-306, 1993.
7. Galla, J.D., M.A. Ergin, A.M. Sadeghi, et al., ``A New Technique
Using Somatosensory Evoked Potential Guidance During Descending and
Thoracoabdominal Aortic Repairs,'' Journal of Cardiac Surgery, vol.
9, pp. 662-672, 1994.
8. Hess, P.J., H.R. Howe, Jr., and F. Robicsek, ``Traumatic Tears of
the Thoracic Aorta: Improved Results Using the Bio-Medicus Pump,''
The Annals of Thoracic Surgery, vol. 48, pp. 6-9, 1989.
9. Cunningham, I.N., J.C. Laschinger, and F.C. Spencer, ``Monitoring
of Somatosensory Evoked Potentials During Surgical Procedures on the
Thoracoabdominal Aorta: Clinical Observations and Results,'' Journal
of Thoracic and Cardiovascular Surgery, vol. 94, pp. 275-285, 1987.
10. The 2012 Panel transcript and other meeting materials are
available on FDA's Web site at http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/MedicalDevices/MedicalDevicesAdvisoryCommittee/CirculatorySystemDevicesPanel/ucm300073.htm.
11. Levine, G.N., E.R. Bates, J.C. Blankenship, et al., ``2011 ACCF/
AHA/SCAI Guideline for Percutaneous Coronary Intervention: A Report
of the American College of Cardiology Foundation/American Heart
Association Task Force on Practice Guidelines and the Society for
Cardiovascular Angiography and Interventions,'' Journal of the
American College of Cardiology, vol. 58, pp. e44-e122, 2011.

List of Subjects in 21 CFR Part 870

    Medical devices, Cardiovascular devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 870 be amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.

0
2. Revise Sec.  870.4360 to read as follows:

Sec.  870.4360  Nonroller-type blood pump.

    (a) Cardiopulmonary and circulatory bypass blood pump--(1)
Identification. A nonroller-type cardiopulmonary and circulatory bypass
blood pump is a prescription device that uses a method other than
revolving rollers to pump the blood through an extracorporeal circuit
for periods lasting less than 6 hours for the purpose of providing
either:
    (i) Full or partial cardiopulmonary bypass (i.e. circuit includes
an oxygenator) during open surgical procedures on the heart or great
vessels, or
    (ii) Temporary circulatory bypass for diversion of flow around a
planned disruption of the circulatory pathway necessary for open
surgical procedures on the aorta or vena cava.
    (2) Classification. Class II (special controls). The special
controls for this device are:
    (i) Nonclinical performance testing must provide a reasonable
assurance of safety and effectiveness with respect to the operating
parameters, dynamic blood damage, heat generation, air entrapment,
mechanical integrity, and durability/reliability to perform as intended
over the intended duration of use;
    (ii) The device must be demonstrated to be biocompatible;
    (iii) Sterility and shelf-life testing must demonstrate the
sterility of patient-contacting components and the shelf-life of these
components; and
    (iv) Labeling must include information regarding the duration of
use, and a detailed summary of the device- and procedure-related
complications pertinent to use of the device.
    (b) Temporary ventricular support blood pump.--(1) Identification.
A nonroller-type temporary ventricular support blood pump is a
prescription device that uses any method resulting in blood propulsion
to provide the temporary ventricular assistance required for support of
the systemic and/or pulmonary circulations during periods when there is
ongoing or anticipated hemodynamic instability due to immediately
reversible alterations in ventricular myocardial function resulting
from mechanical or physiologic causes. Duration of use would be less
than 6 hours.
    (2) Classification. Class III (premarket approval).
    (c) Date premarket approval application (PMA) or notice of
completion of product development protocol (PDP) is required. A PMA or
notice of completion of a PDP is required to be filed with FDA on or
before [A DATE WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A
FUTURE FINAL ORDER IN THE Federal Register], for any temporary
ventricular support blood pump that was in commercial distribution
before May 28, 1976, or that has, on or before [A DATE WILL BE ADDED 90
DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL ORDER IN THE Federal
Register], been found to be substantially equivalent to any temporary
ventricular support blood pump that was in commercial distribution
before May 28, 1976. Any other temporary ventricular support blood pump
shall have an approved PMA or declared completed PDP in effect before
being placed in commercial distribution.

    Dated: January 2, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-00027 Filed 1-6-14; 8:45 am]
BILLING CODE 4160-01-P