information related to their business as well as data for individual
sales. To take part in the CARS program, dealers must register with
NHTSA. The required registration data includes identifying information
and the identity and contact information for a designated CARS contact
person. Once registered, dealers have to submit information needed to
establish a CARS account. This includes the registration data discussed
above and additional data needed for financial transactions. For each
individual sale, dealers also submit dealer data, new vehicle purchaser
data, trade-in vehicle data, and new vehicle data.
3. Disposal Facility Information and Destruction Data
    Disposal Facilities are required to submit certifications to NHTSA
regarding their business operations and to verify proper destruction of
CARS trade-in vehicles.

e. CARS Data Class Determinations Based on FOIA Exemption 4

    With a few exceptions, the data submitted by businesses
participating in the CARS program is already a matter of public record.
Dealer addresses, telephone numbers, fax numbers and e-mail addresses
are freely given. Other information, such as a dealer or salvage yard
business license number, legal name and legal address, are available
through public records. Still more data can be ascertained through
publicly available search engines. For example, Employer Identification
Numbers (EINs) for businesses are routinely released on tax forms,
public filings and, in some instances, on employee pay stubs. As a
result, an employer's EIN may be searched and retrieved by name from a
number of Web based providers for a nominal fee. Nonetheless, some data
provided to NHTSA under the CARS program is not publicly available and
entitled to confidential treatment. This data is discussed below.
1. Manufacturer Assigned Dealer Identification
    Vehicle manufacturers assign identification codes to their
individual dealers. One manufacturer, Ford, indicates that these codes
are confidential and that release of this information would be likely
to cause competitive harm by increasing the possibility of fraud
perpetrated by impostors using dealer codes. Because fraudulent use of
this information would be likely to cause competitive harm, this final
rule establishes a class determination extending confidential treatment
to these manufacturer assigned dealer codes.
2. Dealer Bank Name, ABA Routing Number, Bank Account Number
    Participating dealers will be identifying their bank, its American
Banking Association (ABA) routing number and a bank account number in
forms submitted to NHTSA. This information is kept confidential by
these dealers and its release would cause substantial harm to those
dealers. Public disclosure of this information presents an open and
obvious potential for fraud or abuse that could result in serious
financial loss. Indeed, even the inadvertent disclosure of a bank
account number and a subsequent change to another account can cause
significant disruption in business operations. The agency believes that
a class determination is an appropriate means for protecting this
information.
3. CARS Dealer ID and CARS Authorization Codes
    NHTSA will provide participating dealers with unique identifiers
for CARS purposes and issue CARS authorization codes for individual
CARS transactions. Dealers must use this unique identifier and
authorization code when submitting requests for reimbursement. Public
disclosure of a dealer's unique CARS ID and authorization code
increases the potential that this identifier will be used improperly or
to perpetuate fraud. Unauthorized and improper use of the unique CARS
ID and code would be likely to cause the ``owner'' of the ID to suffer
competitive harm. The legitimate ``owner'' of the ID and authorization
code may be subject to financial claims, suspension or removal from the
CARS program and other costs associated with improper use of a CARS
code and ID. Accordingly, this final rule establishes a class
determination according confidential treatment to this data.

f. Class Determination Based on FOIA Exemption 6

    The CARS rule requires dealers to provide NHTSA with the name,
address, telephone number, state identification number, trade-in
vehicle VIN, trade-in insurance information and new vehicle VIN for
consumers participating in the CARS program. NHTSA has long held the
view that Exemption 6 of the FOIA authorizes confidential treatment of
consumer personally identifying information. See 5 U.S.C. 552(b)(6).
Accordingly, consumer names, addresses and telephone numbers are
routinely accorded confidential treatment. The agency's policy has been
to redact personal identifiers from owner complaints (whether filed
directly with the agency or from documents obtained from manufacturers
in the course of a defect investigation) before placing them on the
public record.
    The privacy interest in protecting personal identifiers and contact
information is no less compelling when a consumer purchases a new
vehicle under the CARS program. Furthermore, disclosure of personal
identifiers and the erosion of privacy that would result might dissuade
consumers from participating in CARS. This would frustrate achievement
of the program's principal goal--to encourage replacement of older less
fuel efficient vehicles with new more fuel-efficient cars and trucks.
    The consumer data at issue--name, address, telephone number, state
identification number and vehicle identification number (VIN)--is
within the scope of Exemption 6. VINs, when coupled with other data,
can be used to identify vehicle owners and obtain other personal data.
As this data has privacy implications, the next inquiry is an
assessment of the public interest in disclosure. Congress has directed
the disclosure of trade-in vehicle VINs to the commercial market to
help verify destruction of these vehicles. For the remaining personal
data, the concept of public interest under Exemption 6 is limited to
shedding light on the government's performance of its statutory duties.
United States Department of Justice v. Reporters Comm. for Freedom of
the Press, 489 U.S. 749, 773 (1989); National Ass'n of Retired Federal
Employees v. Horner, 879 F.2d 873, 879 (D.C. Cir. 1989); cf., DOD v.
FLRA, 510 U.S. 487, 497 (1994).

With the limited redaction of part of the VIN under this rulemaking,
the public would be able to review identification of the make, model
and model year of the new vehicle. This apprises the public of
information central to the core purpose of the CARS program. Disclosing
additional VIN information, with the sequential number unique to the
vehicle, that would enable someone to identify the owner of the new
vehicle and other personal information would not, however, further
serve the public interest. If disclosed, it would not answer the
question of ``what the government is up to.'' Reporters Comm., 489 U.S.
at 773 (1989).
    The final step in an Exemption 6 analysis is weighing the competing
privacy and public interests against one another. See Ripskis v. HUD,
746 F.2d 1, 3 (D.C. Cir. 1984). In the case of the CARS VIN
information, there is a privacy interest in not being contacted about a
new vehicle purchase, such as by companies selling warranties. On the
other hand, the public interest, in terms of information that reveals
``what the government is up to'' is better served by other publicly
available information. On balance, NHTSA has concluded that the privacy
interests in non-disclosure of consumer personal identifying
information outweigh the limited public interest served by disclosing
this information when other data is available to better address public
concerns.
    NHTSA is amending 49 CFR Part 512 by revising Appendix E to provide
new class determinations applying to information provided for the CARS
program. These class determinations do not apply as a rule of general
application to the agency's treatment of similar information in other
instances. Revising Appendix E requires addition of a new Appendix F to
accommodate information previously found in Appendix E.

VI. Costs and Benefits

    The CARS Act will have various economic, employment, safety and
environmental effects. The employment impacts of the Act will affect
NHTSA, and may affect manufacturer and dealer employment. At this time,
NHTSA is planning to hire 30 employees and over 200 contractor
employees to handle this program over a period of 6 months.
Manufacturers' and dealers' employment levels are unlikely to be
impacted by the Act. The impact of the Act will most likely not be
large enough to increase production by manufacturers, and dealers on
average will only be selling an additional 12 vehicles (250,000
estimated number of vehicles sold during the program divided by 19,700
dealers as of early 2009) during the course of the program.
    Another benefit of the program is the increased incorporation of
improved fuel efficiency into the on-road vehicle fleet. This will
decrease greenhouse gases and criteria pollutants by decreasing fuel
consumption, resulting in air pollution benefits. These benefits are
ultimately dependent upon which types of vehicles consumers purchase.
    Certain costs may be incurred by dealers. However, the CARS Act
provides that dealers may retain up to $50 from the scrap value of
trade-in vehicles to offset any administrative costs of participating
in the program. Disposal facilities and salvage auctions will also
incur some costs in complying with the Act. Related industries, such as
auto repair shops, may lose some profit due to foregone repairs by
vehicle owners. Additionally, the Act may shorten the vehicle life
cycle depending on the age and condition of the trade-in vehicles.
    Cost and benefit information associated with this rulemaking is set
forth in the final regulatory impact analysis prepared by NHTSA and
included in the public docket.

VII. Statutory Basis for This Action

    This final rule implements the Consumer Assistance to Recycle and
Save Act (Cars Act) (Pub. L. 111-32), which directs the Secretary to
issue final regulations within 30 days after enactment.

VIII. Effective Date

    Section 1302(d) of the CARS Act provides that notwithstanding the
requirements of section 553 of title 5, United States Code, the
Secretary shall promulgate final regulations to implement the Program
not later than 30 days after the date of the enactment of this Act. The
agency finds that it has good cause to make this rule effective fewer
than 30 days after the publication in the Federal Register. The CARS
program is a short-term program that Congress expected NHTSA to
implement promptly. Under the CARS Act, a credit issued under the
Program may be used only in connection with the purchase or qualifying
lease of new fuel efficient automobiles that occur between July 1,
2009, and November 1, 2009. In view of the fact that the regulations
being published today have not been previously available, sales of new
vehicles under the program have not begun in volume. It would,
therefore, be inconsistent with Congressional intent, impracticable,
and contrary to the public interest, to delay the effective date of the
regulations, which would, in turn, delay the implementation of the
program and effectively compress its applicability.
    This rulemaking is also major under Chapter 8 of 5 U.S.C.
(Congressional Review of Agency Rulemakings) because it has an annual
effect on the economy of $100,000,000 or more. For the same reasons
noted in the prior paragraph, we find good cause under section 808 of
Title 5 that notice and public procedure are impracticable and contrary
to the public interest, and that the rule shall take effect upon
publication in the Federal Register.
    Accordingly, the effective date of this final rule is July 29,
2009.

IX. Regulatory Analyses and Notices

A. Executive Order 12866 and DOT Regulatory Policies and Procedures

    Executive Order 12866, ``Regulatory Planning and Review'' (58 FR
51735, October 4, 1993), provides for making determinations whether a
regulatory action is ''significant'' and therefore subject to Office of
Management and Budget (OMB) review and to the requirements of the
Executive Order. The Order defines a ``significant regulatory action''
as one that is likely to result in a rule that may: (1) Have an annual
effect on the economy of $100 million or more or adversely affect in a
material way the economy, a sector of the economy, productivity,
competition, jobs, the environment, public health or safety, or State,
local, or Tribal governments or communities; (2) create a serious
inconsistency or otherwise interfere with an action taken or planned by
another agency; (3) materially alter the budgetary impact of
entitlements, grants, user fees, or loan programs or the rights and
obligations of recipients thereof; or (4) raise novel legal or policy
issues arising out of legal mandates, the President's priorities, or
the principles set forth in the Executive Order.
    This rulemaking is economically significant. Accordingly, OMB
reviewed it under Executive Order 12866. The rule is also significant
within the meaning of the Department of Transportation's Regulatory
Policies and Procedures. The agency has prepared a Final Regulatory
Impact Analysis (FRIA) and placed it in the docket and on the agency's
Web site.

B. National Environmental Policy Act

    NHTSA has considered this rulemaking action for the purposes of the
National Environmental Policy Act (NEPA). It is established law that
NEPA compliance is required unless there is a clear conflict of
statutory authority.

Calvert Cliffs' Coordinating Committee, inc. v. Atomic Energy
Commission, 449 F.2d 1109 (D.C. Cir 1971). NEPA analysis is not
required where, as here, a statutorily-mandated time frame for the
Government's action does not permit it. See, e.g., Flint Ridge
Development Co. v. Scenic Rivers Ass'n of Oklahoma, 426 U.S. 776 (1976)
and Kandra v. U.S., 145 F. Supp.2d 1192 (D. Or. 2001). The Consumer
Assistance to Recycle and Save Act of 2009 requires the Secretary of
Transportation, through NHTSA, to issue final regulations within 30
days after enactment (i.e., by July 24, 2009) and since it is
impossible to perform a NEPA analysis within this tight time frame, no
NEPA analysis is required prior to issuing the final regulation.

C. Regulatory Flexibility Act

    Pursuant to the Regulatory Flexibility Act of 1980 (5 U.S.C. 601 et
seq., as amended by the Small Business Regulatory Enforcement Fairness
Act (SBREFA) of 1996), whenever an agency is required to provide for
notice and comment for any proposed or final rule, it must prepare and
make available for public comment a regulatory flexibility analysis
that describes the effect of the rule on small entities (i.e., small
businesses, small organizations, and small governmental jurisdictions).
The agency has not prepared a final regulatory flexibility analysis for
this final rule because the Regulatory Flexibility Act does not require
such an analysis when a final rule was not required to be preceded by
an NPRM.\23\ As noted elsewhere in this preamble, the agency determined
that an NPRM was not required for this rulemaking. Nevertheless, the
agency has examined impacts on small entities, including small
businesses, and included them in its regulatory analysis for this final
rule.
---------------------------------------------------------------------------

    \23\ The initial sentence of subsection (a), Section 604, Final
regulatory flexibility analysis, of the Regulatory Flexibility Act
provides that when an agency promulgates a final rule under section
553 of this title, after being required by that section or any other
law to publish a general notice of proposed rulemaking, or
promulgates a final interpretative rule involving the internal
revenue laws of the United States as described in section 603(a),
the agency shall prepare a final regulatory flexibility analysis.
---------------------------------------------------------------------------

D. Executive Order 13132, Federalism

    Executive Order 13132, ``Federalism'' (64 FR 43255, August 10,
1999), requires NHTSA to develop an accountable process to ensure
``meaningful and timely input by State and local officials in the
development of regulatory policies that have federalism implications.''
``Policies that have federalism implications'' are defined in the
Executive Order to include regulations that have substantial direct
effects on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. Under
Executive Order 13132, the agency may not issue a regulation with
federalism implications that imposes substantial direct compliance
costs and that is not required by statute unless the Federal Government
provides the funds necessary to pay the direct compliance costs
incurred by State and local governments or the agency consults with
State and local governments in the process of developing the proposed
regulation. The agency also may not issue a regulation with federalism
implications that preempts a State law without consulting with State
and local officials.
    NHTSA has examined today's final rule pursuant to Executive Order
13132 and concluded that consultation with States, local governments,
or their representatives is not required. The agency has concluded that
the rule does not have federalism implications, because the rule does
not have a substantial direct effect on the States, on the relationship
between the national government and the States, or on the distribution
of power and the responsibilities among the various levels of
government. This rule will have no effect on the ability of States to
adopt and/or implement their own incentive plans.

E. Executive Order 12988

    Pursuant to Executive Order 12988, ``Civil Justice Reform'' the
agency has considered whether this final rule would have any
retroactive effect. Agencies may promulgate retroactive rules pursuant
to the express authority of Congress to do so. See, e.g., Bowen v.
Georgetown Univ. Hospital, 488 U.S. 204, 208 (1988); National Mining
Association v. Dep't of Labor, 292 F.3d 849, 859 (D.C. Cir. 2002). On
June 24, 2009, the President signed the CARS Act into law (Pub. L. 111-
32). The CARS Act required the Secretary of Transportation, acting
through NHTSA, to issue final regulations to implement the program
within 30 days after enactment (i.e., by July 24, 2009). However, the
CARS Act provides that the program covers eligible transactions
beginning on July 1, 2009, prior to today's final rule. Accordingly, as
set forth in today's final rule, if transactions occurring on or after
July 1, 2009 but prior to July 29, 2009 meet all of the requirements
identified in this final rule, registered dealers may follow the
application procedures of the rule and apply for reimbursement for
those transactions.

F. Paperwork Reduction Act

    Under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501, et
seq.), a person is not required to respond to a collection of
information by a Federal agency unless the collection displays a valid
OMB control number. As part of this final rule, the agency must among
other matters, request information from persons to register as
participating dealers, provide a list of eligible vehicles and process
credit transactions under the program.
    The agency has received approval from OMB to collect the following
information:
    Title: CARS Program; Dealer Information, OMB Control No. 2127-0657,
Expiration Date: December 31, 2009.
    This approval covers NHTSA Form 1070. NHTSA has been given OMB
approval to collect 57,000 responses, for a total of 11,395 burden
hours.
    Title: CARS Program; Disposal Facility and Salvage Auction
Information, OMB Control No. 2127-0658, Expiration Date: January 31,
2010.
    This approval covers NHTSA Form 1073, ``Disposal Facility
Certification Form'' and NHTSA Form 1074, ``Salvage Auction
Certification Form.'' NHTSA has been given OMB approval to collect
3,750,000 responses, for a total of 31,248 burden hours.
    Title: CARS Program; Survey of Customer Response to CARS
Initiative, OMB Control No. 2127-0659, Expiration Date: January 31,
2010.
    This approval covers NHTSA Form 1075, ``Survey of Consumer Response
to CARS Initiative.'' NHTSA has been given OMB approval to collect
168,750 responses, for a total of 9,375 burden hours.
    Title: CARS Program; Dealer and Buyer Transaction Information, OMB
Control No. 2127-0660, Expiration Date: January 31, 2010.
    This approval covers NHTSA Form 1071 ``Transaction Form'' (an
electronic form) and NHTSA Form 1072 ``Certifications and Summary of
Sale Language.'' NHTSA has been given OMB approval to collect 500,000
responses, for a total of 108,334 burden hours.

G. The Unfunded Mandates Reform Act

    Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA)
requires Federal agencies to prepare a written assessment of the costs,
benefits, and other effects of proposed or final rules that include a
Federal mandate

likely to result in the expenditure by State, local, or Tribal
governments, in the aggregate, or by the private sector, of more than
$100 million annually (adjusted for inflation with a base year of
1995). This requirement, however, only applies to ``a final rule for
which a general notice of proposed rulemaking was published''; as noted
earlier in this final rule, an NPRM was not published.

H. Regulatory Identifier Number (RIN)

    The Department of Transportation assigns a regulation identifier
number (RIN) to each regulatory action listed in the Unified Agenda of
Federal Regulations. The Regulatory Information Service Center
publishes the Unified Agenda in April and October of each year. You may
use the RIN contained in the heading at the beginning of this document
to find this action in the Unified Agenda.

I. Privacy Act

    Please note that anyone is able to search the electronic form of
all 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 the complete User Notice and Privacy Notice for Regulations.gov
at http://www.regulations.gov/search/footer/privacyanduse.jsp.

List of Subjects

49 CFR Part 512

    Administrative procedure and practice, Confidential business
information, Freedom of information, Motor vehicle safety, Reporting
and record keeping requirements.

49 CFR Part 599

    Fuel economy, Motor vehicle safety.

0
In consideration of the foregoing, NHTSA hereby amends 49 CFR Chapter V
as set forth below.

PART 512--CONFIDENTIAL BUSINESS INFORMATION

0
1. The authority citation for Part 512 continues to read as follows:

    Authority: 49 U.S.C. 322; 5 U.S.C. 552; 49 U.S.C. 30166, 49
U.S.C. 30167; 49 U.S.C. 32307; 49 U.S.C. 32505; 49 U.S.C. 32708; 49
U.S.C. 32910; 49 U.S.C. 33116; delegation of authority at 49 CFR
1.50.

0
2. Revise Appendix E to Part 512 to read as follows:

Appendix E to Part 512--Consumer Assistance to Recycle and Save (CARS)
Class Determinations

    (a) The Chief Counsel has determined that the following
information required to be submitted to the agency under 49 CFR part
599, if released, is likely to cause substantial harm to the
competitive position of the entity submitting the information:
    (1) Vehicle Manufacturer Issued Dealer Identification Code;
    (2) Dealer Bank Name, ABA Routing Number and Bank Account
Number; and
    (3) CARS Dealer Code and Authorization Code.
    (b) The Chief Counsel has determined that the disclosure of the
new vehicle owner's name, home address, telephone number, state
identification number and last six (6) characters, when disclosed
along with the first eleven (11) characters, of the new vehicle
identification numbers reported in transactions submitted to the
agency under 49 CFR Part 599 will constitute a clearly unwarranted
invasion of personal privacy within the meaning of 5 U.S.C.
552(b)(6).

0
3. Add Appendix F to part 512 to read as follows:

Appendix F to Part 512--OMB Clearance

    The OMB clearance number for this part 512 is 2127-0025.

0
4. Add part 599 to read as follows:

PART 599--REQUIREMENTS AND PROCEDURES FOR CONSUMER ASSISTANCE TO
RECYCLE AND SAVE ACT PROGRAM

Subpart A--General
Sec.
599.100 Purpose.
599.101 Scope.
599.102 Definitions.
Subpart B--Participating Dealers, Salvage Auctions and Disposal
Facilities
599.200 Registration of participating dealers.
599.201 Identification of salvage auctions and disposal facilities.
Subpart C--Qualifying Transactions and Reimbursement
599.300 Requirements for qualifying transactions.
599.301 Limitations and restrictions on qualifying transactions.
599.302 Dealer application for reimbursement--submission, contents.
599.303 Agency disposition of dealer application for reimbursement.
599.304 Payment to dealer.
Subpart D--Disposal of Trade-in Vehicle
599.400 Transfer or consignment by dealer of trade-in vehicle.
599.401 Requirements and limitations for disposal Facilities that
receive trade-in vehicles under the CARS program.
599.402 Requirements and limitations for salvage auctions that are
consigned trade-in vehicles under the CARS program.
599.403 Requirements and limitations for dealers.
Subpart E--Enforcement
599.500 Definitions.
599.501 Generally.
599.502 Record retention.
599.503 Access to records.
599.504 Suspension, revocation, and reinstatement of registration
and participation eligibility.
599.505 Reports and investigations.
599.506 Notice of violation.
599.507 Disclosure of evidence.
599.508 Statements of matters in dispute and submission of
supporting information.
599.509 Hearing officer.
599.510 Initiation of action before the hearing officer.
599.511 Counsel.
599.512 Hearing location and costs.
599.513 Hearing procedures.
599.514 Assessment of civil penalties.
599.515 Appeals of civil penalties in excess of $100,000.00.
599.516 Collection of assessed or compromised civil penalties.
599.517 Other sanctions.
Appendix A to Part 599--Summary of Sale/Lease and Certifications
Appendix B to Part 599--Engine Disablement Procedures for the CARS
Program
Appendix C to Part 599--Electronic Transaction Screen
Appendix D to Part 599--CARS Purchaser Survey
Appendix E to Part 599--Disposal Facility Certification Form
Appendix F to Part 599--Salvage Auction Certification Form

    Authority: 49 U.S.C. 32901, Notes; delegation of authority at 49
CFR 1.50.

Subpart A--General

Sec.  599.100  Purpose.

    This part establishes requirements and procedures implementing the
program authorized under the Consumer Assistance to Recycle and Save
Act of 2009.

Sec.  599.101  Scope.

    The requirements of this part apply to new vehicle purchase or
lease transactions, in combination with trade-in vehicle transactions
that occur on or after July 1, 2009 up to and including November 1,
2009, and to the disposal of trade-in vehicles under the CARS Act.

Sec.  599.102  Definitions.

    As used in this part--
    Agency or NHTSA means the National Highway Traffic Safety
Administration.
    CARS Act means the Consumer Assistance to Recycle and Save Act of
2009, Public Law 111-32, 123 Stat. 1859 (June 24, 2009).

    CARS Program means the program authorized under the Consumer
Assistance to Recycle and Save Act of 2009, which NHTSA refers to as
the Car Allowance Rebate System.
    Category 1 truck means a non-passenger automobile, as defined in
section 49 U.S.C. 32901(a)(17) and 49 CFR 523.3, except that such term
does not include a category 2 truck.
    Category 2 truck means a large van with a wheelbase of 124 inches
or more, or a large pickup with a wheelbase of 115 inches or more.
    Category 3 truck means a work truck, as defined in 49 U.S.C.
32901(a)(19).
    Clear title means title to a vehicle that is free from all liens
and encumbrances.
    Combined Fuel Economy means--
    (1) With respect to an eligible new vehicle, the number, expressed
in miles per gallon, centered below the words ``Combined Fuel Economy''
on the label required to be affixed or caused to be affixed on a new
automobile pursuant to subpart D of 40 CFR part 600.
    (2) With respect to an eligible trade-in vehicle of model year 1985
or later, the number posted under the words ``Estimated New EPA MPG''
or ``New EPA MPG'' and above the word ``Combined,'' except that for a
bi-fuel, dual fuel, or flexible fueled vehicle, that number must also
be below the word ``Gasoline,'' on the fueleconomy.gov Web site of the
Environmental Protection Agency for the make, model, and year of such
vehicle.
    Credit means an electronic payment to a dealer for a qualifying
transaction under the program.
    Dealer means a person licensed by a State who engages in the sale
of a new automobile to a person who in good faith purchases such
automobile for purposes other than resale.
    Disposal facility means a facility listed on http://www.cars.gov/
disposal as eligible to receive a trade-in vehicle for crushing or
shredding under the CARS program, except in the case of a U.S.
territory.
    End-of-Life Vehicle Solutions or ELVS means an entity established
under the National Vehicle Mercury Switch Recovery Program for the
collection, recycling and disposal of elemental mercury from automotive
switches.
    Engine block means the part of the engine containing the cylinders
and typically incorporating water cooling jackets and also including
the crank shaft, connecting rods, pistons, bearings, cam(s), and
cylinder head(s). In a rotary engine, the block includes the rotor
housing and rotor.
    GVWR means gross vehicle weight rating.
    Lease means a lease of a new vehicle for a period of not less than
5 years, excluding any lease with a balloon payment due prior to the
elapsing of 5 years.
    Manufacturer's Suggested Retail Price or MSRP means the base
Manufacturer's Suggested Retail Price, excluding any dealer
accessories, optional equipment, taxes and destination charges.
    National Motor Vehicle Title Information System or NMVTIS means the
online system established under the oversight of the Department of
Justice that enables consumers and others to access vehicle history
information, including salvage history, total loss information, and
title branding and odometer information, and to which insurance
companies and salvage yards must report vehicle status information.
(http://www. nmvtis.gov.)
    New Vehicle means an automobile or work truck, the equitable or
legal title of which has not been transferred to any person other than
the purchaser.
    Non-titling Jurisdiction means a State that does not issue a title
for certain typically older vehicles.
    Passenger automobile means a passenger automobile, as defined in
section 49 U.S.C. 32901(a)(18) and 49 CFR 523.4.
    Person means an individual, corporation, company, association,
firm, partnership, society, or joint stock company.
    Purchaser means a person purchasing or leasing a new vehicle under
the CARS Program.
    Salvage auction means an entity that receives a CARS trade-in
vehicle from a dealer and is authorized to sell it only to a disposal
facility on the Disposal Facility List and that will make all the
necessary certifications for salvage auctions under the CARS program.
    State means any one of the 50 United States, the District of
Columbia, Puerto Rico, the Virgin Islands, Guam, American Samoa, or the
Commonwealth of the Northern Mariana Islands.

Subpart B--Participating Dealers, Salvage Auctions and Disposal
Facilities

Sec.  599.200  Registration of participating dealers.

    (a) In general. A dealer may apply for a credit under the CARS
Program only if it meets the Required Dealer Qualifications for
Registration under this subpart, is registered in accordance with this
subpart, and is currently registered at the time it submits an
application for reimbursement.
    (b) Required dealer qualifications for registration. A dealer
seeking to register must have:
    (1) A currently operating new automobile dealership and business
address within a State in the United States;
    (2) A currently active business license under the law of the State
where the new automobile dealership is located to operate that
dealership;
    (3) A currently active franchise agreement to sell new automobiles
with an original equipment manufacturer of automobiles;
    (4) A bank account in a U.S. bank in a State and a bank account
routing number for electronic transfer of funds;
    (5) The ability to submit application materials and perform
transactions electronically using the Internet; and
    (6) Not been convicted of a crime involving motor vehicles or any
fraud or financial crime under State or Federal law.
    (c) Registration procedures.
    (1) Using comprehensive lists of franchised dealers provided by
original equipment manufacturers, as updated by these manufacturers,
the agency will mail a letter to each listed dealer describing a secure
electronic process and providing an authorization code by which the
dealer, following the process in paragraph (c)(2) of this section, can
effect registration.
    (2) A dealer contacted in accordance with paragraph (c)(1) of this
section may register electronically as a participating dealer under the
CARS Program by using the authorization code and following the
instructions provided in the letter mailed under paragraph (c)(1) of
this section, and submitting the following information electronically
or validating the information, where it exists already on an electronic
form:
    (i) Dealer's Federal Tax Identification Number (TIN) and OEM
assigned dealer franchise number;
    (ii) Legal business name, doing business as name (if applicable),
dealership physical and mailing address, telephone number, and fax
number;
    (iii) Name and title of dealer representative authorized to submit
transactions under this program, and phone number and e-mail address of
representative; and
    (iv) Name of U.S. bank used by dealership, bank account number, and
bank account routing number.
    (3) A dealer must register separately, following the process under
paragraph (c)(2) of this section, for each make of vehicle it sells,
using the authorization code associated with that vehicle make.
    (d) Disposition of registration application. The agency will review
the registration application for compliance

with this part, including completeness, and notify the dealer as
follows:
    (1) For an approved registration:
    (i) By e-mail notification to the authorized dealer representative,
with a user identification and password that will allow the submission
of transactions; and
    (ii) By listing the ``doing business as'' name, physical address,
and general telephone number of the dealer on the agency Web site at
http://www.cars.gov.
    (2) For a disapproved registration, by withholding the dealer
identification information from the agency's Web site and providing e-
mail notification to the authorized dealer representative of the
reasons for rejecting the application.
    (e) Revocation of Dealer Registration.
    (1) Termination or Discontinuance of Franchise.
    (i) A dealer whose franchise agreement with an original equipment
manufacturer (OEM) has expired without renewal, has been terminated, or
otherwise is no longer in effect shall be automatically removed as a
matter of course, subject to paragraph (e)(1)(iii), from the agency's
list of registered dealers and may no longer receive a credit for new
transactions under the CARS Program submitted for repayment on or after
the date that the franchise expired or no longer is in effect.
    (ii) Paragraph (e)(1)(i) of this section does not preclude a dealer
registered under other franchise agreements from receiving a credit for
transactions under those agreements that have not expired or been
discontinued.
    (iii) A dealer whose name is removed from the agency's list of
registered dealers under paragraph (e)(1)(i) shall be reinstated to the
list of registered dealers upon a showing to NHTSA of proper and
adequate license to sell new vehicles to ultimate purchasers.
    (2) Other suspension or revocations actions. The agency may also
suspend or revoke the registration of a dealer as provided in Sec.
599.504.
    (f) Notification of changes. A registered dealer shall immediately
notify the agency of any change to the information submitted under this
section and any change to the status of its State license or franchise.
    (g) Pre-registration transactions. An otherwise qualifying
transaction that occurs during the time period prescribed under Sec.
599.301(a) is not a non-complying transaction solely because a dealer
is not registered at the time of the transaction, except that the
dealer must be eligible to register and must register under Sec.
599.200 in order to be entitled to reimbursement for a credit extended
under the CARS program.

Sec.  599.201  Identification of salvage auctions and disposal
facilities.

    (a) Participating entities. Subject to the conditions and
requirements of paragraph (b), participation in the transfer and
disposal of a trade-in vehicle under the CARS program is limited to the
following entities:
    (1) A salvage auction that will transfer trade-in vehicles received
under this program only to a disposal facility identified in paragraph
(b)(2) or (b)(3) of this section.
    (2) A disposal facility listed on the Web site at http://
www.cars.gov/disposal; or
    (3) A facility that disposes of vehicles in Puerto Rico, the Virgin
Islands, Guam, American Samoa, or the Commonwealth of the Northern
Mariana Islands.
    (b) Conditions of Participation. A participating entity identified
in paragraph (a) of this section must:
    (1) Comply with all the provisions and restrictions and make all
the required certifications contained in subpart D of this part.
    (2) In the case of a disposal facility identified in paragraph
(a)(2) of this section, be currently listed on the Web site at http://
www.cars.gov/disposal, as of the date of its participation in the
disposal of the trade-in vehicle.
    (c) Removal of authority to participate.
    (1) A disposal facility that qualifies as such by active membership
in ELVS and that fails to maintain active ELVS membership may be
automatically removed as a matter of course from the agency's list of
disposal facilities maintained at http://www.cars.gov/disposal
authorized to participate in the CARS program.
    (2) The agency may also suspend or remove a salvage auction's or
disposal facility's authority to participate in the CARS program in
accordance with the procedures of Sec.  599.504.

Subpart C--Qualifying Transactions and Reimbursement

599.300  Requirements for qualifying transactions.

    (a) In general. To qualify for a credit under the CARS Program, a
dealer must sell or lease a new vehicle that meets eligibility
requirements to a purchaser, obtain a trade-in vehicle that meets
eligibility requirements from the purchaser, satisfy combined fuel
economy requirements for both the new and trade-in vehicles, disable
the engine of the trade-in vehicle, satisfy the limitations and
restrictions of the program, arrange for disposal of the trade-in
vehicle at a qualifying disposal facility or through a qualifying
salvage auction, and register and submit a complete application for
reimbursement to NHTSA, demonstrating that it meets all the
requirements of this part.
    (b) Threshold eligibility requirements that apply to all trade-in
vehicles. The trade-in vehicle must be:
    (1) In drivable condition, as demonstrated by actual operation of
the motor vehicle on public roads by the dealer and by certification by
the dealer and by the purchaser, as provided in Appendix A to this
part, certifications section, that the vehicle was in drivable
condition on the date of the qualifying transaction;
    (2) Continuously insured consistent with the applicable State law
for a period of not less than 1 year immediately prior to the trade-in,
as demonstrated by:
    (i) One or more current insurance cards specifying the make, model,
model year, and vehicle identification number (VIN) of the insured
vehicle and displaying a continuous one-year period of insurance
coverage; or a copy of an insurance policy document (e.g., a
declarations page or pages) showing a continuous one-year period of
insurance coverage for the vehicle; or a signed letter, on insurance
company letterhead, specifying the same vehicle identification
information (i.e., make, model, model year, and VIN) of the insured
vehicle and identifying the period of continuous coverage, which must
be for at least one year prior to the date of the trade-in; and
    (ii) By certification by the purchaser, as provided in Appendix A
to this part, certifications section, that the vehicle was so insured;
    (3) Continuously registered in a State to the purchaser for a
period of not less than one year immediately prior to the trade-in, as
demonstrated by:
    (i) A current State registration document or series of registration
documents in the name of the purchaser evidencing registration for a
period of not less than one year immediately prior to the trade-in; or
a current State registration document showing registration in the name
of the purchaser and a title that confers title on the purchaser not
less than one year immediately prior to the trade-in; or a current
State registration document showing registration in the name of the
purchaser and a document from a commercially available vehicle history
provider evidencing registration for a period of not less than one year
immediately prior to the trade-in; and
    (ii) By certification by the purchaser, as provided in Appendix A
to this part,

certifications section, that the vehicle was so registered;
    (4) Manufactured less than 25 years before the date of the trade-
in, as demonstrated by model year information on the title or, where
that information is inconclusive, by direct observation by the dealer
of the month and year of the vehicle's manufacture, which appears on
the safety standard certification label of the vehicle, provided that
on the 25th year, the 25-year requirement is satisfied if the
manufacture date falls anytime within the month 25 years before the
date of trade-in, and by certification by the dealer, as provided in
Appendix A to this part, certifications section, that the manufacture
date is less than 25 years before the date of trade-in.
    (c) Threshold eligibility requirements that apply to all new
vehicles. The new vehicle must:
    (1) Be either purchased or leased for a lease period of not less
than 5 years;
    (2) Have a manufacturer's suggested retail price of $45,000 or
less.
    (d) Trade-in vehicle--disclosure of scrap value, engine
disablement, and title marking. As part of a qualifying transaction
under this part, and prior to submitting an application for
reimbursement under Sec.  599.302, the dealer shall:
    (1) During the transaction, disclose to the person purchasing or
leasing an eligible new vehicle and trading in an eligible trade-in
vehicle, the best estimate of the scrap value of the trade-in vehicle,
inform that person that the dealer is authorized to retain $50 of this
amount as payment for its administrative costs of participation in the
program, and certify, as provided in Appendix A to this part,
certifications section, that it has made such disclosure;
    (2) Except as provided in paragraph (e) of this section, disable
the engine of the eligible trade-in vehicle, following the procedures
set forth in Appendix B to this part, and certify, as provided in
Appendix A to this part, certifications section, that it has disabled
the engine; and
    (3) Legibly mark the front and back of the trade-in vehicle's title
in prominent letters that do not obscure the owner's name, VIN, or
other writing as follows: ``Junk Automobile, CARS.gov.''
    (e) Dealer transfers prior to July 24, 2009.
    (1) Subject to the provisions of paragraph (e)(2) of this section,
if the dealer transferred the vehicle prior to July 24, 2009, the
dealer may either:
    (i) Locate the vehicle, disable its engine following the procedures
set for the in Appendix B to this part, and provide the certification
in Appendix A to this part, certifications section, that it has
disabled the engine; or
    (ii) Obtain a sworn affidavit from a disposal facility that it has
crushed or shredded the vehicle, including the engine block, and
provide supporting documents sufficient to establish that fact.
    (2) The dealer and disposal facility must comply with all other
requirements of this part, including the requirement that the trade-in
vehicle be crushed or shredded, except that the affidavit and
supporting documents provided for under paragraph (e)(1)(ii) of this
section may substitute for the disposal facility certification form.
    (f) Qualifying transactions ($3,500 Credit). Subject to the
requirements of paragraphs (b), (c), and (d), and, if applicable,
paragraph (e) of this section and the additional requirements of
Sec. Sec.  599.301, 599.302, and 599.303 of this subpart, each of the
following transactions qualifies for a credit of $3,500 under this
program:
    (1) The new vehicle is a passenger automobile with a combined fuel
economy of at least 22 mpg, the eligible trade-in vehicle has a
combined fuel economy of 18 mpg or less and is a passenger automobile,
category 1 truck, or category 2 truck, and the combined fuel economy of
the new vehicle is at least 4 mpg, but less than 10 mpg higher than the
combined fuel economy of the eligible trade-in vehicle.
    (2) The new vehicle is a category 1 truck with a combined fuel
economy of at least 18 mpg, the eligible trade-in vehicle has a
combined fuel economy of 18 mpg or less and is a passenger automobile,
category 1 truck, or category 2 truck, and the combined fuel economy of
the new vehicle is at least 2 mpg, but less than 5 mpg higher than the
combined fuel economy of the eligible trade-in vehicle.
    (3) The new vehicle is a category 2 truck with a combined fuel
economy of at least 15 mpg, the eligible trade-in vehicle has a
combined fuel economy of 18 mpg or less and is a category 2 truck, and
the combined fuel economy of the new vehicle is 1 mpg higher than the
combined fuel economy of the eligible trade-in vehicle.
    (4) The new vehicle is a category 2 truck with a combined fuel
economy of at least 15 mpg and the eligible trade-in vehicle is a
category 3 truck of model year 2001 or earlier.
    (5) The new vehicle is a category 3 truck, the eligible trade-in
vehicle is a category 3 truck of model year 2001 or earlier, and the
new fuel efficient vehicle has a GVWR less than or equal to the GVWR of
the eligible trade-in vehicle.
    (g) Qualifying transactions ($4,500 Credit). Subject to the
requirements of paragraphs (b), (c), and (d), and, if applicable,
paragraph (e) of this section and the additional requirements of
Sec. Sec.  599.301, 599.302, and 599.303 of this subpart, each of the
following transactions qualifies for a credit of $4,500 under this
program:
    (1) The new vehicle is a passenger automobile with a combined fuel
economy of at least 22 mpg, the eligible trade-in vehicle has a
combined fuel economy of 18 mpg or less and is a passenger automobile,
category 1 truck, or category 2 truck, and the combined fuel economy of
the new vehicle is at least 10 mpg higher than the combined fuel
economy of the eligible trade-in vehicle.
    (2) The new vehicle is a category 1 truck with a combined fuel
economy of at least 18 mpg, the eligible trade-in vehicle has a
combined fuel economy of 18 mpg or less and is a passenger automobile,
category 1 truck, or category 2 truck, and the combined fuel economy of
the new vehicle is at least 5 mpg higher than the combined fuel economy
of the eligible trade-in vehicle.
    (3) The new vehicle is a category 2 truck with a combined fuel
economy of at least 15 mpg, the eligible trade-in vehicle has a
combined fuel economy of 18 mpg or less and is a category 2 truck, and
the combined fuel economy of the new vehicle is at least 2 mpg higher
than the combined fuel economy of the eligible trade-in vehicle.
    (h) No other qualifying transactions. Transactions described under
paragraphs (f) and (g) of this section are the only transactions that
qualify for payment of a credit to a dealer under the CARS Program.

Sec.  599.301  Limitations and restrictions on qualifying transactions.

    (a) Date of transaction. A qualifying transaction may not occur on
a date before July 1, 2009 or after November 1, 2009, and is subject to
available agency funds for the CARS Program.
    (b) One credit per transaction. Only one credit may be applied
towards the purchase or lease price of each new vehicle.
    (c) One credit per person. A person that participates in a
transaction for which a credit is issued under the CARS Program,
whether as a single owner or a joint-registered owner of either an
eligible trade-in vehicle, a new vehicle, or both, may not participate
or be named in another transaction for which a credit is issued under
the CARS program, either as a registered owner of

the trade-in vehicle or as a purchaser of the new vehicle.
    (d) Transfer of title.
    (1) Except as provided in paragraph (d)(2) of this section, a
dealer may not apply for or receive reimbursement for a credit extended
to a purchaser under a CARS program transaction unless it has been
conveyed clear title and physically possesses the title to the trade-in
vehicle.
    (2) In the case of a trade-in vehicle registered in a State that is
a non-titling jurisdiction and that, in accordance with State law, has
no title, the requirement in paragraph (d)(1) of this section that
clear title be conveyed is satisfied if the purchaser shows proof of
registration in the purchaser's name and provides a bill of sale
conferring ownership of the trade-in vehicle to the dealer.

Sec.  599.302  Dealer application for reimbursement--submission,
contents.

    (a) In general. A dealer's application for reimbursement must
demonstrate that the requirements and limitations governing qualifying
transactions in Sec.  599.300 and Sec.  599.301 of this subpart have
been met, and must comply with the submission and contents requirements
of this section.
    (b) Electronic submission. The application for reimbursement must
be submitted by using the login and password provided under Sec.
599.200(d)(1) and following the procedures provided in the letter
mailed under Sec.  599.200(c)(1) of this part.
    (c) Application contents. An application shall consist of an
electronic transaction form (portion reproduced in Appendix C to this
part) requiring input of information into relevant fields, electronic
copies of supporting documents, and applicable certifications, as
provided in Appendix A to this part, certifications section. As its
application for each transaction, the dealer shall:
    (1) Input the following information into relevant fields on the
transaction form:
    (i) Purchaser information.
    (A) Name. The first name, middle initial and last name of each
purchaser, if an individual, or the full legal name of the company,
association or other organization that is the purchaser.
    (B) Residence address (or, for an organization, business address).
The full address of each purchaser.
    (C) Driver's license or State identification number. The State
driver's license or State identification number of each purchaser or,
for an organization, its tax identification number.
    (ii) Trade-in vehicle information.
    (A) Make. The make of the vehicle.
    (B) Model. The model of the vehicle.
    (C) Model year. The model year of the vehicle.
    (D) Vehicle identification number (VIN). The 17 digit VIN of the
vehicle.
    (E) CARS Act vehicle category. The category of vehicle as defined
under the CARS Act. (Enter, as applicable, passenger automobile,
category 1 truck, category 2 truck or category 3 truck.)
    (F) State of title.
    (G) State of registration.
    (H) Start date of registration.
    (I) Start date of insurance.
    (J) End date of registration.
    (K) Odometer reading. The odometer reading of the vehicle at the
time of the trade-in.
    (L) EPA combined fuel economy. The listed EPA combined fuel economy
of the vehicle.
    (M) Vehicle description. The exact ``vehicle description'' for the
vehicle found on http://www.fueleconomy.gov.
    (iii) New vehicle information.
    (A) Make. The make of the vehicle.
    (B) Model. The model of the vehicle.
    (C) Model year. The model year of the vehicle.
    (D) Vehicle identification number (VIN). The 17 digit VIN of the
vehicle.
    (E) EPA combined fuel economy. The listed EPA combined fuel economy
of the vehicle.
    (F) CARS Act vehicle category. The category of vehicle as defined
under the CARS Act. (Enter, as applicable, passenger automobile,
category 1 truck, category 2 truck or category 3 truck.)
    (G) Base manufacturer's suggested retail price (MSRP). The price of
the new vehicle affixed to the Monroney label prior to the addition of
any options, features, taxes or destination charges.
    (H) Vehicle description. The exact ``vehicle description'' for the
vehicle found on http://www.fueleconomy.gov.
    (iv) Trade-in vehicle disposition information.
    (A) Identification of entity. The name, address and telephone
number of the disposal facility or salvage auction to which the vehicle
will be or has been transferred or consigned.
    (B) Disposal facility number. The unique identifier assigned to the
disposal facility identified on the CARS Web site, and to which the
vehicle is being transferred or consigned.
    (v) Transaction information.
    (A) Date of sale or lease. The date on which the vehicle
transaction with the purchaser occurred.
    (B) Transaction request amount. The amount of the credit for which
the dealer is applying.
    (2) Attach the following supporting documentation in electronic
format (pdf, tif, jpeg) in the following order:
    (i) Proof of title. A copy of the front and back of the title of
the trade-in vehicle, showing assignment to the dealer free and clear
of any lien or encumbrance on the vehicle's title, with the ``Junk
Automobile, CARS.gov'' marking on both sides.
    (ii) Proof of insurance. A copy of insurance policy cards or
documents for the trade-in vehicle to confirm that the trade-in vehicle
insurance was continuous for a period of not less than one year prior
to trade in.
    (iii) Proof of registration. A copy of the registration card or
documents for the trade-in vehicle identifying the owner, the vehicle,
and dates of registration to confirm that the vehicle was registered to
the purchaser for a period of not less than one year prior to trade in.
    (iv) Purchaser identification.
    (v) Summary of sale/lease and certifications form (Appendix A to
this part, summary section).
    (vi) Manufacturer certificate of origin or manufacturer statement
of origin of the new vehicle.
    (vii) CARS purchaser survey.
    (viii) Fueleconomy.gov side-by-side comparison of the trade-in
vehicle and the new vehicle.
    (ix) Certification from salvage auction or disposal facility.
    (x) Copy of vehicle sales or lease contract.
    (3) Make the certifications provided in Appendix A to this part,
certifications section.

599.303  Agency disposition of dealer application for reimbursement.

    (a) Application review. Upon receipt of an application for
reimbursement, the agency shall review the application to determine
whether it is complete and satisfies all the requirements of this
subpart.
    (b) Complying application. An application that is determined to
meet all the requirements of this subpart shall be approved for
payment, in accordance with the provisions of Sec.  599.304.
    (c) Non-complying application. An application that is incomplete or
that otherwise fails to meet all the requirements of this subpart shall
be rejected, and the submitter shall be informed electronically of the
reason for rejection. NHTSA shall have no obligation to correct a non-
conforming submission.
    (d) Electronic rejection. An application is automatically rejected,
with system notification to the tendering dealer, if the transaction
falls

outside of the permissible time period, exceeds the permissible MSRP,
identifies a purchaser that has participated in a previous transaction,
or identifies the vehicle identification number of a new or trade-in
vehicle that was involved in a previous transaction.
    (e) Correction and resubmission. A dealer may correct and resubmit
a rejected application for reimbursement, without penalty.

Sec.  599.304  Payment to dealer.

    Upon completion of review of an application for reimbursement from
a registered dealer that satisfies all the requirements of this part,
the agency shall reimburse the dealer, by electronic transfer to the
account identified under the process in Sec.  599.200(c) of this part.

Subpart D--Disposal of Trade-in Vehicle

Sec.  599.400  Transfer or consignment by dealer of trade-in vehicle.

    (a) In general.
    (1) A trade-in vehicle accepted as part of an eligible transaction
may be provided for disposal by a dealer either to a disposal facility
or to a salvage auction, as described in and subject to the conditions
of Sec.  599.201 of this part.
    (2) Dealers, disposal facilities, and salvage auctions involved in
the disposal of the trade-in vehicle must each comply with the
applicable provisions of this subpart.
    (b) Transfer by dealer or salvage auction to a disposal facility.
If the trade-in vehicle is transferred by the dealer or salvage auction
to a disposal facility, the disposal facility must, as a condition of
the transfer:
    (1) Make the certifications contained in the Disposal Facility
Certification Form in Appendix E to this part, signed by an official
with authority to bind the disposal facility;
    (2) At the time of the transfer, deliver the signed Disposal
Facility Certification Form to the dealer or salvage auction that
transferred the trade-in vehicle; and
    (3) Comply with the requirements and limitations of Sec.  599.401.
    (c) Consignment by dealer to a salvage auction. If the trade-in
vehicle is consigned by the dealer to a salvage auction, the salvage
auction must, as a condition of the consignment:
    (1) Make the certifications contained in the Salvage Auction
Certification Form in Appendix F to this part, signed by an official
with authority to bind the salvage auction;
    (2) At the time of the consignment, deliver the signed Salvage
Auction Certification Form to the dealer that authorized the salvage
auction to sell the trade-in vehicle.
    (1) Make the certifications contained in the Salvage Auction
Certification Form to the dealer that authorized the salvage auction to
sell the trade-in vehicle; and
    (3) Comply with the requirements and limitations of Sec.  599.402.

Sec.  599.401  Requirements and limitations for disposal facilities
that receive trade-in vehicles under the CARS program.

    (a) The disposal facility must:
    (1) Not more than 7 days after receiving the vehicle, report the
vehicle to NMVTIS as a scrap vehicle.
    (2) Remove and dispose of all refrigerants, antifreeze, lead
products, mercury switches, and such other toxic or hazardous vehicle
components prior to crushing or shredding in accordance with applicable
Federal and State requirements;
    (3) Crush or shred the trade-in vehicle onsite, including the
engine block and the drive train (unless with respect to the drive
train, the transmission, drive shaft, and rear end are sold
separately), using its own machinery or a mobile crusher, within 180
days after receipt of the vehicle from the dealer or salvage auction;
    (4) Not more than 7 days after the vehicle is crushed or shredded,
report the vehicle to NMVTIS as crushed or shredded.
    (b) The disposal facility may not sell or transfer the engine block
of the vehicle or, except as allowed under paragraph (c)(2) of this
section, the drive train before they are crushed or shredded or
otherwise allow the vehicle to leave the disposal facility before it is
crushed or shredded.
    (c) The disposal facility may:
    (1) Sell any part of the vehicle other than the engine block or
drive train;
    (2) Notwithstanding paragraph (c)(1) of this section, sell the
drive train provided the transmission, drive shaft, and rear end are
sold as separate parts;
    (3) Retain the proceeds from parts sold under this paragraph.

Sec.  599.402  Requirements and limitations for salvage auctions that
are consigned trade-in vehicles under the CARS program.

    (a) The salvage auction must:
    (1) Within 3 days after the date the dealer consigns the vehicle or
prior to auctioning the vehicle, whichever is earlier, report the
status of the vehicle to NMVTIS;
    (2) Limit participation in the auction to disposal facilities that,
when the auction is held:
    (i) Appear on the list identified in Sec.  599.201(a)(2) or are
described in Sec.  599.201(a)(3); and
    (ii) Agree to make the certifications in the Salvage Auction
Certification Form (Appendix F to this part).
    (3) As a condition of transferring title to the disposal facility,
obtain from that facility the signed Disposal Facility Certification
Form (Appendix E to this part), insert on the top of the form the
appropriate CARS invoice number received from the dealer, if known, and
provide the form to NHTSA at<EMAIL_ADDRESS>and include that
invoice number in the e-mail subject line.
    (b) [Reserved]

Sec.  599.403  Requirements and limitations for dealers.

    A dealer receiving a Disposal Facility Certification Form or
Salvage Auction Certification Form under Sec.  599.400(b)(2) or (c)(2)
shall insert on the top of the form the appropriate CARS invoice
number, if known, and within 7 days of receipt, submit such
certification form to NHTSA at<EMAIL_ADDRESS>
Subpart E--Enforcement

Sec.  599.500  Definitions.

    As used in this subpart--
    Administrator means the Administrator of the National Highway
Traffic Safety Administration, or his or her designee.
    Chief Counsel means the NHTSA Chief Counsel, or his or her
designee.
    Hearing Officer means a NHTSA employee who has been delegated the
authority to assess civil penalties.
    NHTSA Enforcement means the NHTSA Associate Administrator for
Enforcement, or his or her designee.
    Notice of violation means a notification of violation and
preliminary assessment of penalty issued by the Chief Counsel to a
party.
    Party means the person alleged to have committed a violation of the
CARS Act, regulations thereunder, or other applicable law, and includes
an individual, a public or private corporation, and a partnership or
other association.
    Violation means any non-conformance with the CARS Act or the
regulations in this part except Sec.  599.200(e)(1)(i) and Sec.
599.201(c)(1), the submission of incomplete or inaccurate information
to NHTSA or an entity identified under this part, or the failure to
maintain records, to permit access to records or to update information
that has been submitted to NHTSA under this part, but does not include
a clerical error. In the context of dealer registration and disposal
facility or salvage auction participation eligibility, violation also
includes any

conviction of a crime involving motor vehicles or any fraud or
financial crime under State or Federal law.

Sec.  599.501  Generally.

    The provisions of 5 U.S.C. 554, 556 and 557 do not apply to any
proceedings conducted pursuant to this subpart.

Sec.  599.502  Record retention.

    (a) Manufacturers, dealers, salvage auctions, and disposal
facilities shall keep records of all transactions under the CARS Act
and regulations thereunder for a period of five calendar years from the
date on which they were generated or acquired by the manufacturer,
salvage auction, dealer, or disposal facility, and shall promptly make
those records available to NHTSA Enforcement or DOT's Office of the
Inspector General upon request.
    (b) Records to be retained under this subpart include all
documentary materials and other information-storing media that contain
information concerning transactions under the CARS Program, including
any material generated or communicated by computer, electronic mail, or
other electronic means. Such records include, but are not limited to,
lists, compilations, certifications, dealer application information,
salvage auction or disposal facility information, owner eligibility
information, vehicle eligibility information (including vehicle fuel
economy), dealer applications for reimbursement under the program,
vehicle identification number data, vehicle ownership information,
vehicle title, registration and insurance information, sales
agreements, bills of sale, lease agreements, manufacturer's certificate
or statement of origin, other rebate and/or incentive programs used in
conjunction with transactions under the program, bank account and
routing number information, electronic funds transfer and payment
information, reports made to the National Motor Vehicle Title
Information System (NMVTIS), reports regarding vehicle scrappage values
and payment, reports in connection with the transfer of vehicles to
salvage auctions and disposal facilities; reports from disposal
facilities in connection with the crushing or shredding of vehicles
under the program, and any other documents that are related to
transactions.
    (c) Duplicate copies need not be retained. Information may be
reproduced or transferred from one storage medium to another (e.g.,
from electronic format to CD-ROM) as long as no information is lost in
the reproduction or transfer, and when so reproduced or transferred the
original form may be treated as a duplicate.

Sec.  599.503  Access to records.

    The Administrator shall have the right to enter onto the premises
of manufacturers, dealers, salvage auctions and disposal facilities
during normal business hours in order to: access, inspect and audit
records and other sources of information maintained by any of these
entities under this Program; to inspect vehicles traded in or sold
under this program, including taking all actions necessary to determine
whether trade-in vehicles have operative engines; and/or to interview
persons who may have relevant knowledge.

Sec.  599.504  Suspension, revocation, and reinstatement of
registration and participation eligibility.

    (a) Suspension or revocation of dealer registration, or salvage
auction or disposal facility participation eligibility.
    (1) When the NHTSA Chief Counsel determines that a violation has
likely occurred, the Administrator may notify the dealer, salvage
auction or disposal facility in writing of the facts giving rise to the
allegation of a violation and the proposed length of a suspension, if
applicable, or revocation of registration, in the case of a dealer, or
participation eligibility in the case of a salvage auction or disposal
facility.
    (2) The notice shall afford the dealer, salvage auction or disposal
facility an opportunity to present data, views, and arguments, in
writing and/or in person, within 30 days of the date of the notice, as
to whether the violation occurred, why its registration or
participation eligibility ought not to be suspended or revoked, or
whether the suspension should be shorter than proposed. The
Administrator may, for good cause, reduce the time allowed for
response.
    (3) If the Administrator decides, on the basis of the available
information, that the dealer, salvage auction or disposal facility has
committed a violation, the Administrator may suspend or revoke the
dealer registration or the participation eligibility of the salvage
auction or disposal facility.
    (4) The Administrator shall notify the dealer, salvage auction or
disposal facility in writing of the decision, including the reasons for
it. The decision shall reflect the gravity of the offense.
    (5) A suspension or revocation is effective as of the date of the
Administrator's written notification, unless another date is specified
therein.
    (6) The Administrator shall state the period of any suspension in
the notice to the dealer, salvage auction or disposal facility.
    (7) There shall be no opportunity to seek reconsideration of the
Administrator's decision issued under this paragraph (a).
    (b) Reinstatement of suspended registration or participation
eligibility.
    (1) When a registration or participation eligibility has been
suspended under this subpart, the registration or participation
eligibility will be reinstated after the expiration of the period of
suspension specified by the Administrator, or such earlier date as the
Administrator may subsequently decide is appropriate.
    (2) Reinstatement is automatically effective as of the date
previously set forth in the Administrator's written notification of
suspension, unless another date is specified by the Administrator in
writing.
    (c) Effect of suspension or revocation of registration or
participation eligibility.
    (1) If a dealer's registration or a salvage auction or disposal
facility's participation eligibility is suspended or revoked, as of the
date of suspension or revocation, the dealer, salvage auction or
disposal facility will not be considered registered or eligible to
participate in the CARS Program, and must cease participating in the
program.
    (2) A dealer whose registration has been suspended will not be
entitled to any rights or reimbursement of funds for new transactions
submitted as of the effective date of the suspension or revocation.
    (3) NHTSA may take such action as appropriate, including
publication, to provide notice that a dealer's registration, or salvage
auction's or disposal facility's participation eligibility has been
suspended or revoked.

Sec.  599.505  Reports and investigations.

    (a) Any person may report an apparent violation of the CARS Act or
regulations issued thereunder to NHTSA.
    (b) NHTSA may independently monitor for violations of the CARS Act
or regulations issued thereunder.
    (c) When a report of an apparent violation has been received by
NHTSA, or when an apparent violation has been detected by any person
working for NHTSA, the matter may be investigated or evaluated by NHTSA
Enforcement. If NHTSA Enforcement believes that a violation may have
occurred, NHTSA Enforcement may prepare a report and send the report to
the NHTSA Chief Counsel.

    (d) The NHTSA Chief Counsel will review the reports prepared by
NHTSA Enforcement to determine if there is sufficient information to
establish a likely violation.
    (1) The matter may be returned to NHTSA Enforcement for further
investigation, if warranted.
    (2) The Chief Counsel may close a matter. A matter may be closed
if, for example, the investigation has established that a violation did
not occur, the alleged violator is unknown, there is insufficient
information to support the existence of a violation and little
likelihood of discovering additional relevant facts, or the magnitude
of the matter is, under the circumstances, including availability of
resources, insufficient to be pursued further.
    (3) If the Chief Counsel determines that a violation has likely
occurred, the Chief Counsel may:
    (i) Issue a Notice of Violation to the party, and/or
    (ii) In the case of a dealer recommend that the Administrator
suspend or revoke registration in the program or in the case of a
salvage auction or disposal facility, recommend that the Administrator
suspend or revoke participation eligibility in the program.
    (4) In the case of either paragraphs (d)(3)(i) or (ii) of this
section, the NHTSA Chief Counsel will prepare a case file with
recommended actions. A record of any prior violations by the same
person or entity, shall be forwarded with the case file.

Sec.  599.506  Notice of Violation.

    (a) The agency has the authority to assess a civil penalty for any
violation of the CARS Act or this part. The penalty may not be more
than $15,000 for each violation.
    (b) The Chief Counsel may issue a Notice of Violation to a party.
Notice of Violation will contain the following information:
    (1) The name and address of the party;
    (2) The alleged violation and the applicable law or regulations
violated;
    (3) The amount of the maximum penalty that may be assessed for each
violation;
    (4) The amount of proposed penalty;
    (5) A statement that payment of the proposed penalty within 30 days
will settle the case without admission of liability;
    (6) The place to which, and the manner in which, payment is to be
made;
    (7) A statement that the party may decline the Notice of Violation
and that if the Notice of Violation is declined, the party has the
right to a hearing prior to a final assessment of a penalty by a
Hearing Officer.
    (8) A statement that failure to either pay the proposed penalty on
the Notice of Violation or to decline the Notice of Violation and
request a hearing within 30 days of the date shown on the Notice of
Violation will result in a finding of violation by default and that
NHTSA will proceed with the civil penalty in the amount proposed on the
Notice of Violation without processing the violation under the hearing
procedures set forth in this subpart.
    (c) The Notice of Violation may be delivered to the party by:
    (1) Hand-delivery to the party or an employee of the party;
    (2) Mailing to the party (certified mail is not required);
    (3) Use of an overnight or express courier service; or
    (4) Facsimile transmission or electronic mail (with or without
attachments) to the party or an employee of the party.
    (d) If a party submits a written request for a hearing as provided
in the Notice of Violation within 30 days of the date shown on the
Notice of Violation, the case file will be sent to the Hearing Officer
for processing under the hearing procedures set forth in this subpart.
    (e) If a party pays the proposed penalty on the Notice of Violation
or an amount agreed on in compromise within 30 days of the date shown
on the Notice of Violation, a finding of ``resolved with payment'' will
be entered into the case file. Such payment shall not be an admission
of liability.
    (f) If the party agrees to pay the proposed penalty, but has not
made payment within 30 days of the date shown on the Notice of
Violation, NHTSA will enter a finding of violation by default in the
matter and NHTSA will proceed with the civil penalty in the amount
proposed on the Notice of Violation without processing the violation
under the hearing procedures set forth in this subpart.
    (g) If within 30 days of the date shown on the Notice of Violation
a party fails to pay the proposed penalty on the Notice of Violation;
and fails to request a hearing, then NHTSA will enter a finding of
violation by default in the case file, and will assess the civil
penalty in the amount set forth on the Notice of Violation without
processing the violation under the hearing procedures set forth in this
subpart.
    (h) NHTSA's order assessing the civil penalty following a party's
default is final agency action.

Sec.  599.507  Disclosure of evidence.

    The alleged violator may, upon request, receive a free copy of all
the written evidence in the case file, except material that would
disclose or could lead to the disclosure of the identity of a
confidential source. Following a timely request for a hearing, other
evidence or material, if any, of whatever source or nature, may be
examined at the Hearing Officer's offices or such other places and
locations that the Hearing Officer may, in writing, direct, if there
are adequate safeguards to prevent loss or tampering.

Sec.  599.508  Statements of matters in dispute and submission of
supporting information.

    (a) Within 30 days of the date shown on the Notice of Violation,
the party, or counsel for the party, shall submit to NHTSA at the
person or office listed in the Notice of Violation two complete copies
via hand delivery, use of an overnight or express courier service,
facsimile or electronic mail of:
    (1) A detailed statement of factual and legal issues in dispute;
and,
    (2) All statements and documents supporting the party's case.
    (b) One copy of the party's submission set forth above shall be
labeled ``For Hearing Officer.''
    (c) Failure to specify any non-jurisdictional issue in the party's
submission will preclude its consideration.

Sec.  599.509  Hearing Officer.

    (a) If a party timely requests a hearing after receiving a Notice
of Violation, the Hearing Officer shall hear the case.
    (b) The Hearing Officer is solely responsible for the case referred
to him or her. The Hearing Officer has no other responsibility, direct
or supervisory, for the investigation of cases referred for the
assessment of civil penalties.
    (c) The Hearing Officer decides each case on the basis of the
information before him or her, and must have no prior connection with
the case.

Sec.  599.510  Initiation of action before the Hearing Officer.

    (a) After the Hearing Officer receives a case file from the Chief
Counsel, the Hearing Officer notifies the party in writing of:
    (1) The date, time and location of the hearing and whether the
hearing will be conducted telephonically or at the DOT Headquarters
building in Washington, D.C.;
    (2) The right to be represented at all stages of the proceeding by
counsel as set forth in Sec.  599.511; and,
    (3) The right to a free copy of all written evidence in the case
file as set forth in Sec.  599.507.

    (b) On the request of a party, or at the Hearing Officer's
direction, multiple proceedings may be consolidated if at any time it
appears that such consolidation is necessary or desirable.

Sec.  599.511  Counsel.

    A party has the right to be represented at all stages of the
proceeding by counsel. A party electing to be represented by counsel
must notify the Hearing Officer of this election in writing, after
which point the Hearing Officer will direct all further communications
to that counsel. A party represented by counsel bears all of its own
attorneys' fees and costs.

Sec.  599.512  Hearing location and costs.

    (a) Unless the party requests a hearing at which the party appears
before the Hearing Officer in Washington, DC, the hearing shall be held
telephonically. The hearing is held at the headquarters of the U.S.
Department of Transportation in Washington, DC.
    (b) The Hearing Officer may transfer a case to another Hearing
Officer at a party's request or at the Hearing Officer's direction.
    (c) A party is responsible for all fees and costs (including
attorneys' fees and costs, and costs that may be associated with travel
or accommodations) associated with attending a hearing.

Sec.  599.513  Hearing procedures.

    (a) There is no right to discovery in any proceedings conducted
pursuant to this subpart.
    (b) The material in the case file pertinent to the issues to be
determined by the Hearing Officer is presented by the Chief Counsel or
his or her designee.
    (c) The Chief Counsel may supplement the case file with information
prior to the hearing. A copy of such information will be provided to
the party no later than 3 days before the hearing.
    (d) At the close of the Chief Counsel's presentation of evidence,
the party has the right to examine, respond to and rebut material in
the case file and other information presented by the Chief Counsel.
    (e) In receiving evidence, the Hearing Officer is not bound by
strict rules of evidence. In evaluating the evidence presented, the
Hearing Officer must give due consideration to the reliability and
relevance of each item of evidence.
    (f) A party may present the testimony of any witness either through
a written statement or a personal appearance. If a party wishes to
present testimony through a personal appearance, the party is
responsible for obtaining that personal appearance, including any costs
associated with such appearance. The Hearing Officer may, at his or her
discretion, accept a stipulation in lieu of testimony.
    (g) At the close of the party's presentation of evidence, the
Hearing Officer may allow the introduction of rebuttal evidence that
may be presented by the Chief Counsel. The Hearing Officer may allow
the party to respond to any such evidence submitted.
    (h) The Hearing Officer may take notice of matters which are
subject to a high degree of indisputability and are commonly known in
the community or are ascertainable from readily available sources of
known accuracy. Prior to taking notice of a matter, the Hearing Officer
shall give the party an opportunity to show why notice should not be
taken. In any case in which notice is taken, the Hearing Officer places
a written statement of the matters as to which notice was taken in the
record, with the basis for such notice, including a statement that the
party consented to notice being taken or a summary of the party's
objections.
    (i) After the evidence in the case has been presented, the Chief
Counsel and the party may present argument on the issues in the case.
The party may also request an opportunity to submit a written statement
for consideration by the Hearing Officer and for further review. If
granted, the Hearing Officer shall allow a reasonable time for
submission of the statement and shall specify the date by which it must
be received. If the statement is not received within the time
prescribed, or within the limits of any extension of time granted by
the Hearing Officer, the Hearing Officer prepares the decision in the
case.
    (j) A verbatim transcript of the hearing will not normally be
prepared. A party may, solely at its own expense, cause a verbatim
transcript to be made. If a verbatim transcript is made, the party
shall submit two copies to the Hearing Officer not later than 15 days
of the hearing. The Hearing Officer shall include such transcript in
the record.

Sec.  599.514  Assessment of civil penalties.

    (a) Not later than 30 days following the close of the hearing, the
Hearing Officer shall issue a written decision on the Notice of
Violation, based on the hearing record. The decision shall set forth
the basis for the Hearing Officer's assessment of a civil penalty, or
decision not to assess a civil penalty. In determining the amount of
the civil penalty, the severity of the violation and the intent and
history of the party committing the violation shall be taken into
account. The assessment of a civil penalty by the Hearing Officer shall
be set forth in an accompanying final order.
    (b) If the Hearing Officer assesses civil penalties in excess of
$100,000.00, the Hearing Officer's decision contains a statement
advising the party of the right to an administrative appeal to the
Administrator. The party is advised that failure to submit an appeal
within the prescribed time will bar its consideration and that failure
to appeal on the basis of a particular issue will constitute a waiver
of that issue in its appeal before the Administrator.
    (c) The filing of a timely and complete appeal to the Administrator
of a Hearing Officer's order assessing a civil penalty shall suspend
the operation of the Hearing Officer's penalty.
    (d) There shall be no administrative appeals of civil penalties of
$100,000.00 or less.

Sec.  599.515  Appeals of civil penalties in excess of $100,000.00.

    (a) A party may appeal the Hearing Officer's order assessing civil
penalties over $100,000.00 to the Administrator within 21 days of the
date of the issuance of the Hearing Officer's order.
    (b) The Administrator will affirm the decision of the Hearing
Officer unless the Administrator finds that the Hearing Officer's
decision was unsupported by the record as a whole.
    (c) If the Administrator finds that the decision of the Hearing
Officer was unsupported, in whole or in part, then the Administrator
may:
    (1) Assess or modify a civil penalty;
    (2) Rescind the Notice of Violation; or
    (3) Remand the case back to the Hearing Officer for new or
additional proceedings.
    (d) In the absence of a remand, the decision of the Administrator
in an appeal is a final agency action.

Sec.  599.516  Collection of assessed or compromised civil penalties.

    (a) Payment of a civil penalty, whether assessed or compromised,
shall be made by check, postal money order, or electronic transfer of
funds, as provided in instructions by the agency. A payment of civil
penalties shall not be considered a request for a hearing.
    (b) The party must remit payment of any assessed civil penalty to
NHTSA within 30 days after receipt of the Hearing Officer's order
assessing civil penalties or, in the case of an appeal to the
Administrator, within 30 days after receipt of the Administrator's
decision on the appeal. Failure to make timely payment may result in
the institution of appropriate action under the Federal Claims
Collection Act, as amended, the

regulations issued thereunder, and other applicable law.
    (c) The party must remit payment of any compromised civil penalty
to NHTSA on the date and under such terms and conditions as agreed to
by the party and NHTSA. Failure to pay a compromised civil penalty to
NHTSA on the date and under such terms and conditions as agreed to by
the party and NHTSA may either result in the institution of appropriate
action under the Federal Claims Collection Act, as amended, the
regulations issued thereunder, and other applicable law, or NHTSA
entering a finding of violation by default and assessing a civil
penalty in the amount proposed in the Notice of Violation without
processing the violation under the hearing procedures set forth in this
part.

Sec.  599.517  Other sanctions.

    The procedures and penalties described in this subpart are not the
only procedures and penalties that may apply to someone who violates
the CARS Act or submits a false certification required by this rule.
Anyone who submits false information on these forms or otherwise
violates the CARS Act or this part may not only be subject to the
procedures and penalties described in this subpart, but also civil and
criminal penalties. Such civil and criminal penalties may include
penalties three times any amount falsely claimed to be due from the
United States pursuant to the False Claims Act (31 U.S.C. 3729), or
imprisonment of up to 5 years and fines of up to $250,000 (18 U.S.C.
1001). In addition, NHTSA may request that the Attorney General seek
appropriate injunctive relief to address violations of the CARS Act or
this part.
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    Issued on: July 23, 2009.
Ronald L. Medford,
Acting Deputy Administrator.
[FR Doc. E9-17994 Filed 7-24-09; 4:15 pm]

BILLING CODE 4910-59-C


[Federal Register: February 2, 2010 (Volume 75, Number 21)]
[Notices]
[Page 5333]
[DOCID:fr02fe10-79]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0001]

Endocrinologic and Metabolic Drugs Advisory Committee;
Cancellation

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The meeting of the Endocrinologic and Metabolic Drugs Advisory
Committee scheduled for February 24, 2010, is cancelled. This meeting
was announced in the Federal Register of January 19, 2010 (75 FR 2875).
This meeting has been cancelled due to unexpected delays in the
preparation of materials for the meeting. The agency will reschedule
this meeting and announce a future meeting date in the Federal
Register.

FOR FURTHER INFORMATION CONTACT: Paul Tran, Center for Drug Evaluation
and Research (HFD-21), Food and Drug Administration, 5600 Fishers Lane
(for express delivery, 5630 Fishers Lane, rm. 1093), Rockville, MD
20857,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-
0572 in the Washington, DC area), code<PHONE_NUMBER>. Please call the
Information Line for up-to-date information on this meeting.

    Dated: January 26, 2010.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2010-2096 Filed 2-1-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 149 (Thursday, August 2, 2018)]
[Notices]
[Pages 37813-37816]
[FR Doc No: 2018-16537]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-0126]

Revocation of Authorization of Emergency Use of an In Vitro
Diagnostic Device for Detection of Ebola Virus

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the Emergency Use Authorization (EUA) (the Authorization)
issued to Zalgen Labs, LLC for the ReEBOV Antigen Rapid Test. FDA
revoked this Authorization on May 18, 2018, under the Federal Food,
Drug, and Cosmetic Act (FD&C Act), as requested by Zalgen Labs, LLC by
letter dated March 1, 2018. The revocation, which includes an
explanation of the reasons for revocation, is reprinted in this
document.

DATES: The Authorization is revoked as of May 18, 2018.

ADDRESSES: Submit written requests for single copies of the revocation
to the Office of Counterterrorism and Emerging Threats, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a Fax number to which
the revocation may be sent. See the SUPPLEMENTARY INFORMATION section
for electronic access to the revocation.

FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of
Counterterrorism and Emerging Threats, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 1, Rm. 4336, Silver Spring, MD 20993-
0002,<PHONE_NUMBER> (this is not a toll-free number).

SUPPLEMENTARY INFORMATION:

I. Background

    Section 564 of the FD&C Act (21 U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L. 108-276) and the Pandemic and
All-Hazards Preparedness Reauthorization Act of 2013 (Pub. L. 113-5)
allows FDA to strengthen the public health protections against
biological, chemical, nuclear, and radiological agents. Among other
things, section 564 of the FD&C Act allows FDA to authorize the use of
an unapproved medical product or an unapproved use of an approved
medical product in certain situations. On February 24, 2015, FDA issued
an EUA to Corgenix, Inc. for the ReEBOV Antigen Rapid Test, subject to
the terms of the Authorization. Notice of the issuance of the
Authorization was published in the Federal Register on June 5, 2015 (80
FR 32140), as required by section 564(h)(1) of the FD&C Act. In
response to requests from Zalgen Labs, LLC and Corgenix, Inc. to
transfer ownership of the EUA for the ReEBOV Antigen Rapid Test from
Corgenix, Inc. to Zalgen Labs, LLC, FDA amended and reissued the EUA to
Zalgen Labs, LLC

in its entirety on November 3, 2016. Under section 564(g)(2), the
Secretary of Health and Human Services may revoke an EUA if, among
other things, the criteria for issuance are no longer met or other
circumstances make such revocation appropriate to protect the public
health or safety.

II. EUA Revocation Request for an In Vitro Diagnostic Device for
Detection of the Ebola Virus

    Pursuant to a request from Zalgen Labs, LLC on March 1, 2018, FDA
revoked the EUA for the ReEBOV Antigen Rapid Test on May 18, 2018,
because the criteria for issuance were no longer met and these
circumstances made such revocation appropriate to protect the public
health or safety.

III. Electronic Access

    An electronic version of this document and the full text of the
revocation are available on the internet at https://www.regulations.gov.

IV. The Revocation

    Having concluded that the criteria for revocation of the
Authorization under section 564(g) of the FD&C Act are met, FDA has
revoked the EUA for Zalgen Labs, LLC's ReEBOV Antigen Rapid Test. The
revocation in its entirety follows and provides an explanation of the
reasons for revocation, as required by section 564(h)(1) of the FD&C
Act.

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[GRAPHIC] [TIFF OMITTED] TN02AU18.007

    Dated: July 27, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-16537 Filed 8-1-18; 8:45 am]
 BILLING CODE 4164-01-C


[Federal Register Volume 82, Number 211 (Thursday, November 2, 2017)]
[Proposed Rules]
[Page 50853]
[FR Doc No: 2017-23706]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2017-0323; FRL-9970-16-Region 5]

Air Plan Approval; Illinois; Volatile Organic Compounds
Definition

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve a state submission as a revision to the Illinois state
implementation plan (SIP) for ozone. The revision, submitted on May 30,
2017, incorporates changes to the Illinois Administrative Code
definition of volatile organic material, otherwise known as volatile
organic compounds (VOC). The revision removes recordkeeping and
reporting requirements related to the use of t-butyl acetate (also
known as tertiary butyl acetate) as a VOC, and is in response to an EPA
rulemaking that occurred in 2016. Illinois also added information to
provide clarity to the list of compounds excluded from the definition
of VOC.

DATES: Comments must be received on or before December 4, 2017.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2017-0323 at http://www.regulations.gov or via email to
[email protected]. For comments submitted at Regulations.gov,
follow the online instructions for submitting comments. Once submitted,
comments cannot be edited or removed from Regulations.gov. For either
manner of submission, EPA may publish any comment received to its
public docket. Do not submit electronically any information you
consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. Multimedia
submissions (audio, video, etc.) must be accompanied by a written
comment. The written comment is considered the official comment and
should include discussion of all points you wish to make. EPA will
generally not consider comments or comment contents located outside of
the primary submission (i.e. on the web, cloud, or other file sharing
system). For additional submission methods, please contact the person
identified in the FOR FURTHER INFORMATION CONTACT section. For the full
EPA public comment policy, information about CBI or multimedia
submissions, and general guidance on making effective comments, please
visit http://www2.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Charles Hatten, Environmental
Engineer, Control Strategies Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER>, [email protected].

SUPPLEMENTARY INFORMATION: In the Final Rules section of this issue of
the Federal Register, EPA is approving the Illinois's SIP submittal as
a direct final rule without prior proposal because the Agency views
this as a noncontroversial submittal and anticipates no adverse
comments. A detailed rationale for the approval is set forth in the
direct final rule. If no adverse comments are received in response to
this rule, no further activity is contemplated. If EPA receives adverse
comments, the direct final rule will be withdrawn and all public
comments received will be addressed in a subsequent final rule based on
this proposed rule. EPA will not institute a second comment period. Any
parties interested in commenting on this action should do so at this
time. Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule, and if that provision may be
severed from the remainder of the rule, EPA may adopt as final those
provisions of the rule that are not the subject of an adverse comment.
For additional information, see the direct final rule which is located
in the Rules section of this issue of the Federal Register.

    Dated: October 17, 2017.
Robert A. Kaplan,
Acting Regional Administrator, Region 5.
[FR Doc. 2017-23706 Filed 11-1-17; 8:45 am]
BILLING CODE 6560-50-P