81 FR 5754 - Lithia Motors, Inc.; Analysis of Proposed Consent Order To Aid Public Comment
FEDERAL TRADE COMMISSION Federal Register Volume 81, Issue 22 (February 3, 2016)
Federal Register Volume 81, Issue 22 (February 3, 2016)
| Page Range | 5754-5756 | |
| FR Document | 2016-01944 |
[Federal Register Volume 81, Number 22 (Wednesday, February 3, 2016)] [Notices] [Pages 5754-5756] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-01944] ----------------------------------------------------------------------- FEDERAL TRADE COMMISSION [File No. 152-3102] Lithia Motors, Inc.; Analysis of Proposed Consent Order To Aid Public Comment AGENCY: Federal Trade Commission. ACTION: Proposed consent agreement. ----------------------------------------------------------------------- SUMMARY: The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order--embodied in the consent agreement--that would settle these allegations. DATES: Comments must be received on or before February 29, 2016. ADDRESSES: Interested parties may file a comment at https://ftcpublic.commentworks.com/ftc/lithiamotorsconsent online or on paper, by following the instructions in the Request for Comment part of the SUPPLEMENTARY INFORMATION section below. Write ``Lithia Motors, Inc.-- Consent Agreement; File No. 152-3102'' on your comment and file your comment online at https://ftcpublic.commentworks.com/ftc/lithiamotorsconsent by following the instructions on the Web-based form. If you prefer to file your comment on paper, write ``Lithia Motors, Inc.--Consent Agreement; File No. 152-3102'' on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. FOR FURTHER INFORMATION CONTACT: Evan Zullow (202) 326-2914 or Courtney Estep (202) 326-2788, Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580. SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for January 28, 2016), on the World Wide Web at: http://www.ftc.gov/os/actions.shtm. You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before February 29, 2016. Write ``Lithia Motors, Inc.--Consent Agreement; File No. 152- 3102'' on your comment. Your comment--including your name and your state--will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at http://www.ftc.gov/os/publiccomments.shtm. As a matter of discretion, the Commission tries to remove individuals' home contact information from comments before placing them on the Commission Web site. Because your comment will be made public, you are solely responsible for making sure that your comment does [[Page 5755]] not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any ``[t]rade secret or any commercial or financial information which . . . is privileged or confidential,'' as discussed in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names. If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).\1\ Your comment will be kept confidential only if the FTC General Counsel, in his or her sole discretion, grants your request in accordance with the law and the public interest. --------------------------------------------------------------------------- \1\ In particular, the written request for confidential treatment that accompanies the comment must include the factual and legal basis for the request, and must identify the specific portions of the comment to be withheld from the public record. See FTC Rule 4.9(c), 16 CFR 4.9(c). --------------------------------------------------------------------------- Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at https://ftcpublic.commentworks.com/ftc/lithiamotorsconsent by following the instructions on the web-based form. If this Notice appears at http://www.regulations.gov/#!home, you also may file a comment through that Web site. If you file your comment on paper, write ``Lithia Motors, Inc.-- Consent Agreement; File No. 152-3102'' on your comment and on the envelope, and mail your comment to the following address: Federal Trade Commission, Office of the Secretary, 600 Pennsylvania Avenue NW., Suite CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the following address: Federal Trade Commission, Office of the Secretary, Constitution Center, 400 7th Street SW., 5th Floor, Suite 5610 (Annex D), Washington, DC 20024. If possible, submit your paper comment to the Commission by courier or overnight service. Visit the Commission Web site at http://www.ftc.gov to read this Notice and the news release describing it. The FTC Act and other laws that the Commission administers permit the collection of public comments to consider and use in this proceeding as appropriate. The Commission will consider all timely and responsive public comments that it receives on or before February 29, 2016. You can find more information, including routine uses permitted by the Privacy Act, in the Commission's privacy policy, at http://www.ftc.gov/ftc/privacy.htm. Analysis of Proposed Consent Order To Aid Public Comment The Federal Trade Commission (``FTC'' or ``Commission'') has accepted, subject to final approval, an agreement containing a consent order from Lithia Motors, Inc. The proposed consent order has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the FTC will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order. The respondent is a car dealership that sells used motor vehicles. According to the FTC complaint, respondent has represented that the used motor vehicles it sells have been subject to rigorous inspection, including for safety issues, but has failed to disclose that the used motor vehicles it sells are subject to open recalls for safety issues. For instance, the respondent has posted advertisements on its Web site that make the following representations about vehicles that carry a dealer-backed ``60 Day/3000 Mile'' warranty: ``160-Point Quality Inspection--Lithia 60 Day/3,000 Mile vehicles are put through an exhaustive 160-checkpoint Quality Assurance Inspection. We want the vehicles to look, feel and smell as new as possible. We inspect everything from the tires and the brakes to the suspension, drive train, engine components and even the undercarriage. Only vehicles that pass all 160 checkpoints (as appropriate to vehicle content) can receive our 60 Day/3,000 miles Limited Warranty. See dealer for details.'' Even though it makes such claims, the respondent has allegedly advertised on its Web sites numerous Lithia 60-Day/3,000 Mile used vehicles that were subject to open recalls for safety issues. In numerous instances, when the respondent allegedly advertised Lithia 60- Day/3,000 Mile used vehicles that are subject to open recalls for safety issues, it provided no accompanying clear and conspicuous disclosure of this fact. The proposed complaint alleges that this failure to disclose constitutes a deceptive act or practice under Section 5 of the FTC Act. The proposed order is designed to prevent the respondent from engaging in similar deceptive practices in the future. Part I prohibits the respondent from representing that used motor vehicles it offers for sale are safe, have been repaired for safety issues, or have been subject to an inspection for issues related to safety unless the used motor vehicles are not subject to any open recalls for safety issues or the respondent discloses, clearly and conspicuously, in close proximity to such representation, any material qualifying information related to open recalls for safety issues. Part II is a provision that orders the respondent to notify every consumer who purchased from it a 60-Day/ 3,000 Mile used motor vehicle between July 1, 2013 and the date of entry of the Order that some of the used vehicles it sold during this time had been recalled for safety issues which weren't repaired as of the date they were sold, how to determine whether a vehicle is subject to an unrepaired recall, and information on how to get a vehicle fixed if it is subject to an open recall. Parts III through VII of the proposed order are reporting and compliance provisions. Part III requires the respondent to maintain for five years, and produce to the Commission upon demand, any relevant ads and associated documentary material. Part IV is an order distribution provision that requires the respondent to provide the Order to current and future principals, officers, directors, and managers, and to all current employees, agents, and representatives having responsibilities with respect to the subject matter of the Order. Part V requires the respondent to notify the Commission of corporate changes that may affect compliance obligations. Part VI requires the respondent to submit a compliance report to the Commission 60 days after entry of the order, and also additional compliance reports within 10 business days of a written request by the Commission. Part VII ``sunsets'' the order after twenty years, with certain exceptions. The purpose of this analysis is to aid public comment on the proposed order. [[Page 5756]] It is not intended to constitute an official interpretation of the complaint or proposed order, or to modify in any way the proposed order's terms. By direction of the Commission. Donald S. Clark, Secretary. [FR Doc. 2016-01944 Filed 2-2-16; 8:45 am] BILLING CODE 6750-01-P
![5754 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
that make the following representations Parts III through VII of the proposed below. Write ‘‘Lithia Motors, Inc.—
about vehicles that purportedly undergo order are reporting and compliance Consent Agreement; File No. 152–3102’’
a rigorous 172-point inspection: provisions. Part III requires the on your comment and file your
respondent to maintain for five years, comment online at https://
We Check It, So You Don’t Have to
and produce to the Commission upon ftcpublic.commentworks.com/ftc/
172-Point Inspection and demand, any relevant ads and lithiamotorsconsent by following the
Reconditioning associated documentary material. Part instructions on the Web-based form. If
* * * * * IV is an order distribution provision that you prefer to file your comment on
Our 172-Point Vehicle Inspection and requires the respondent to provide the paper, write ‘‘Lithia Motors, Inc.—
Reconditioning Process is conducted Order to certain current and future Consent Agreement; File No. 152–3102’’
only by highly trained technicians and principals, officers, and directors, and to on your comment and on the envelope,
adheres to strict, factory-set standards to all current employees, agents, and and mail your comment to the following
ensure that every vehicle’s engine, representatives having responsibilities address: Federal Trade Commission,
chassis, and body are in excellent with respect to the subject matter of the Office of the Secretary, 600
condition. The technicians ensure that Order. Part V requires the respondent to Pennsylvania Avenue NW., Suite CC–
everything from the drivetrain to the notify the Commission of corporate 5610 (Annex D), Washington, DC 20580,
windshield wipers is in good working changes that may affect compliance or deliver your comment to the
order, or they recondition it to our obligations. Part VI requires the following address: Federal Trade
exacting standards. The vehicles are respondent to submit a compliance Commission, Office of the Secretary,
road-tested, put up on a lift for a report to the Commission 60 days after Constitution Center, 400 7th Street SW.,
complete underbody and frame entry of the order, and also additional 5th Floor, Suite 5610 (Annex D),
inspection, and then completely compliance reports within 10 business Washington, DC 20024.
checked for any cosmetic flaws. days of a written request by the FOR FURTHER INFORMATION CONTACT:
And we do check it all. From the Commission. Part VII ‘‘sunsets’’ the Evan Zullow (202) 326–2914 or
engine block to the shocks, right down order after twenty years, with certain Courtney Estep (202) 326–2788, Bureau
to the floor mats, no major system is exceptions. of Consumer Protection, 600
overlooked. If it fails a single point, we The purpose of this analysis is to aid Pennsylvania Avenue NW., Washington,
completely recondition it—or it won’t public comment on the proposed order. DC 20580.
be Certified. It is not intended to constitute an
SUPPLEMENTARY INFORMATION: Pursuant
Even though it makes such claims, the official interpretation of the complaint
to Section 6(f) of the Federal Trade
respondent has allegedly advertised on or proposed order, or to modify in any
Commission Act, 15 U.S.C. 46(f), and
its Web site numerous Certified Pre way the proposed order’s terms.
FTC Rule 2.34, 16 CFR 2.34, notice is
Owned (‘‘CPO’’) vehicles that were By direction of the Commission. hereby given that the above-captioned
subject to open recalls for safety issues. Donald S. Clark, consent agreement containing consent
In numerous instances, when the Secretary. order to cease and desist, having been
respondent allegedly advertised CPO [FR Doc. 2016–01946 Filed 2–2–16; 8:45 am] filed with and accepted, subject to final
vehicles that are subject to open recalls BILLING CODE 6750–01–P approval, by the Commission, has been
for safety issues, it provided no placed on the public record for a period
accompanying clear and conspicuous of thirty (30) days. The following
disclosure of this fact. The proposed FEDERAL TRADE COMMISSION Analysis to Aid Public Comment
complaint alleges that this failure to describes the terms of the consent
[File No. 152–3102]
disclose constitutes a deceptive act or agreement, and the allegations in the
practice under Section 5 of the FTC Act. Lithia Motors, Inc.; Analysis of complaint. An electronic copy of the
The proposed order is designed to Proposed Consent Order To Aid Public full text of the consent agreement
prevent the respondent from engaging in Comment package can be obtained from the FTC
similar deceptive practices in the future. Home Page (for January 28, 2016), on
Part I prohibits the respondent from AGENCY: Federal Trade Commission. the World Wide Web at: http://
representing that used motor vehicles it ACTION: Proposed consent agreement. www.ftc.gov/os/actions.shtm.
markets or advertises are safe, have been You can file a comment online or on
repaired for safety issues, or have been SUMMARY: The consent agreement in this
paper. For the Commission to consider
subject to a rigorous inspection unless matter settles alleged violations of
your comment, we must receive it on or
the used motor vehicles are not subject federal law prohibiting unfair or
before February 29, 2016. Write ‘‘Lithia
to any open recalls for safety issues or deceptive acts or practices. The attached
Motors, Inc.—Consent Agreement; File
the respondent discloses, clearly and Analysis to Aid Public Comment
No. 152–3102’’ on your comment. Your
conspicuously, in close proximity to describes both the allegations in the
comment—including your name and
such representation, any material draft complaint and the terms of the
your state—will be placed on the public
qualifying information related to open consent order—embodied in the consent
record of this proceeding, including, to
recalls for safety issues. Part II is a agreement—that would settle these
the extent practicable, on the public
provision that orders the respondent to allegations.
Commission Web site, at http://
notify every consumer who purchased a DATES: Comments must be received on www.ftc.gov/os/publiccomments.shtm.
or before February 29, 2016.
mstockstill on DSK4VPTVN1PROD with NOTICES
CPO used motor vehicle from a GM As a matter of discretion, the
dealership between July 1, 2013 and the ADDRESSES: Interested parties may file a Commission tries to remove individuals’
date of entry of the Order, and whose comment at https:// home contact information from
vehicle has not had the open recall ftcpublic.commentworks.com/ftc/ comments before placing them on the
repaired, that (1) the consumer’s vehicle lithiamotorsconsent online or on paper, Commission Web site.
has been recalled for safety issues that by following the instructions in the Because your comment will be made
have not been repaired, and (2) how to Request for Comment part of the public, you are solely responsible for
get the vehicle repaired. SUPPLEMENTARY INFORMATION section making sure that your comment does
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![Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices 5755
not include any sensitive personal possible, submit your paper comment to 3,000 Mile used vehicles that were
information, like anyone’s Social the Commission by courier or overnight subject to open recalls for safety issues.
Security number, date of birth, driver’s service. In numerous instances, when the
license number or other state Visit the Commission Web site at respondent allegedly advertised Lithia
identification number or foreign country http://www.ftc.gov to read this Notice 60-Day/3,000 Mile used vehicles that
equivalent, passport number, financial and the news release describing it. The are subject to open recalls for safety
account number, or credit or debit card FTC Act and other laws that the issues, it provided no accompanying
number. You are also solely responsible Commission administers permit the clear and conspicuous disclosure of this
for making sure that your comment does collection of public comments to fact. The proposed complaint alleges
not include any sensitive health consider and use in this proceeding as that this failure to disclose constitutes a
information, like medical records or appropriate. The Commission will deceptive act or practice under Section
other individually identifiable health consider all timely and responsive 5 of the FTC Act.
information. In addition, do not include public comments that it receives on or The proposed order is designed to
any ‘‘[t]rade secret or any commercial or before February 29, 2016. You can find prevent the respondent from engaging in
financial information which . . . is more information, including routine similar deceptive practices in the future.
privileged or confidential,’’ as discussed uses permitted by the Privacy Act, in Part I prohibits the respondent from
in Section 6(f) of the FTC Act, 15 U.S.C. the Commission’s privacy policy, at representing that used motor vehicles it
46(f), and FTC Rule 4.10(a)(2), 16 CFR http://www.ftc.gov/ftc/privacy.htm. offers for sale are safe, have been
4.10(a)(2). In particular, do not include repaired for safety issues, or have been
Analysis of Proposed Consent Order To
competitively sensitive information subject to an inspection for issues
Aid Public Comment
such as costs, sales statistics, related to safety unless the used motor
inventories, formulas, patterns, devices, The Federal Trade Commission vehicles are not subject to any open
manufacturing processes, or customer (‘‘FTC’’ or ‘‘Commission’’) has accepted, recalls for safety issues or the
names. subject to final approval, an agreement respondent discloses, clearly and
If you want the Commission to give containing a consent order from Lithia conspicuously, in close proximity to
your comment confidential treatment, Motors, Inc. The proposed consent order such representation, any material
you must file it in paper form, with a has been placed on the public record for qualifying information related to open
request for confidential treatment, and thirty (30) days for receipt of comments recalls for safety issues. Part II is a
you have to follow the procedure by interested persons. Comments provision that orders the respondent to
explained in FTC Rule 4.9(c), 16 CFR received during this period will become notify every consumer who purchased
4.9(c).1 Your comment will be kept part of the public record. After thirty from it a 60-Day/3,000 Mile used motor
confidential only if the FTC General (30) days, the FTC will again review the vehicle between July 1, 2013 and the
Counsel, in his or her sole discretion, agreement and the comments received, date of entry of the Order that some of
grants your request in accordance with and will decide whether it should the used vehicles it sold during this
the law and the public interest. withdraw from the agreement and take time had been recalled for safety issues
Postal mail addressed to the appropriate action or make final the which weren’t repaired as of the date
Commission is subject to delay due to agreement’s proposed order. they were sold, how to determine
heightened security screening. As a The respondent is a car dealership whether a vehicle is subject to an
result, we encourage you to submit your that sells used motor vehicles. unrepaired recall, and information on
comments online. To make sure that the According to the FTC complaint, how to get a vehicle fixed if it is subject
Commission considers your online respondent has represented that the to an open recall.
comment, you must file it at https:// used motor vehicles it sells have been Parts III through VII of the proposed
ftcpublic.commentworks.com/ftc/ subject to rigorous inspection, including order are reporting and compliance
lithiamotorsconsent by following the for safety issues, but has failed to provisions. Part III requires the
instructions on the web-based form. If disclose that the used motor vehicles it respondent to maintain for five years,
this Notice appears at http:// sells are subject to open recalls for and produce to the Commission upon
www.regulations.gov/#!home, you also safety issues. demand, any relevant ads and
may file a comment through that Web For instance, the respondent has associated documentary material. Part
site. posted advertisements on its Web site IV is an order distribution provision that
If you file your comment on paper, that make the following representations requires the respondent to provide the
write ‘‘Lithia Motors, Inc.—Consent about vehicles that carry a dealer- Order to current and future principals,
Agreement; File No. 152–3102’’ on your backed ‘‘60 Day/3000 Mile’’ warranty: officers, directors, and managers, and to
comment and on the envelope, and mail ‘‘160-Point Quality Inspection—Lithia all current employees, agents, and
your comment to the following address: 60 Day/3,000 Mile vehicles are put representatives having responsibilities
Federal Trade Commission, Office of the through an exhaustive 160-checkpoint with respect to the subject matter of the
Secretary, 600 Pennsylvania Avenue Quality Assurance Inspection. We want Order. Part V requires the respondent to
NW., Suite CC–5610 (Annex D), the vehicles to look, feel and smell as notify the Commission of corporate
Washington, DC 20580, or deliver your new as possible. We inspect everything changes that may affect compliance
comment to the following address: from the tires and the brakes to the obligations. Part VI requires the
Federal Trade Commission, Office of the suspension, drive train, engine respondent to submit a compliance
Secretary, Constitution Center, 400 7th components and even the undercarriage. report to the Commission 60 days after
mstockstill on DSK4VPTVN1PROD with NOTICES
Street SW., 5th Floor, Suite 5610 Only vehicles that pass all 160 entry of the order, and also additional
(Annex D), Washington, DC 20024. If checkpoints (as appropriate to vehicle compliance reports within 10 business
content) can receive our 60 Day/3,000 days of a written request by the
1 In particular, the written request for confidential
miles Limited Warranty. See dealer for Commission. Part VII ‘‘sunsets’’ the
treatment that accompanies the comment must details.’’ order after twenty years, with certain
include the factual and legal basis for the request,
and must identify the specific portions of the
Even though it makes such claims, the exceptions.
comment to be withheld from the public record. See respondent has allegedly advertised on The purpose of this analysis is to aid
FTC Rule 4.9(c), 16 CFR 4.9(c). its Web sites numerous Lithia 60-Day/ public comment on the proposed order.
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![5756 Federal Register / Vol. 81, No. 22 / Wednesday, February 3, 2016 / Notices
It is not intended to constitute an • Mail: Division of Toxicology and Monday through Friday, except for legal
official interpretation of the complaint Human Health Sciences, Agency for holidays, from 9 a.m. until 5 p.m.,
or proposed order, or to modify in any Toxic Substances and Disease Registry, Eastern Time, at 4770 Buford Hwy NE.,
way the proposed order’s terms. 1600 Clifton Rd. NE., MS F–57, Atlanta, Atlanta, Georgia 30341. Please call
By direction of the Commission. GA, 30329. Attn: Docket No. ATSDR– ahead to 1–800–232–4636 and ask for a
Donald S. Clark,
2016–0001. representative in the Division of
Instructions: All submissions received Toxicology and Human Health Sciences
Secretary.
must include the agency name and to schedule your visit.
[FR Doc. 2016–01944 Filed 2–2–16; 8:45 am]
docket number for this notice. All
BILLING CODE 6750–01–P Availability
relevant comments will be posted
without change. Because all public The Glutaraldehyde Toxicological
comments regarding ATSDR Profile is available online at http://
DEPARTMENT OF HEALTH AND Toxicological Profiles are available for www.atsdr.cdc.gov/toxprofiles/
HUMAN SERVICES public inspection, no confidential index.asp and www.regulations.gov,
business information or other Docket No. ATSDR–2016–0001.
Agency for Toxic Substances and confidential information should be
Disease Registry Donna B. Knutson,
submitted in response to this notice.
Acting Director, Office of Policy, Planning
[Docket No. ATSDR–2016–0001] FOR FURTHER INFORMATION CONTACT: Ms. and Evaluation, National Center for
Delores Grant, Division of Toxicology Environmental Health and Agency for Toxic
Availability of Draft Toxicological and Human Health Sciences, Agency for Substances and Disease Registry.
Profile; Glutaraldehyde Toxic Substances and Disease Registry, [FR Doc. 2016–01972 Filed 2–2–16; 8:45 am]
AGENCY: Agency for Toxic Substances 1600 Clifton Rd. NE., MS F–57, Atlanta, BILLING CODE 4163–70–P
and Disease Registry (ATSDR), GA, 30329. Phone: (800) 232–4636 or
Department of Health and Human 770–488–3351.
Services (DHHS). SUPPLEMENTARY INFORMATION: The DEPARTMENT OF HEALTH AND
ACTION: Notice of availability and Superfund Amendments and HUMAN SERVICES
request for comment. Reauthorization Act of 1986 (SARA) (42
U.S.C. 9601 et seq.) amended the Food and Drug Administration
SUMMARY: This notice, prepared by the Comprehensive Environmental [Docket No. FDA–2015–D–4599]
Agency for Toxic Substances and Response, Compensation, and Liability
Disease Registry (ATSDR), announces Act of 1980 (CERCLA or Superfund) (42 List of Highest Priority Devices for
the availability of the Toxicological U.S.C. 9601 et seq.) by establishing Human Factors Review; Draft
Profile for Glutaraldehyde for review certain requirements for ATSDR and the Guidance for Industry and Food and
and comment. All toxicological profiles U.S. Environmental Protection Agency Drug Administration Staff; Availability
issued as ‘‘Drafts for Public Comment’’ (U.S. EPA) regarding hazardous
represent ATSDR’s best efforts to substances that are most commonly AGENCY: Food and Drug Administration,
provide important toxicological found at facilities on the CERCLA HHS.
information on priority hazardous National Priorities List (NPL). Among ACTION: Notice.
substances. We are seeking public these statutory requirements is a
comments and additional information or SUMMARY: The Food and Drug
mandate for the Administrator of
reports on studies about the health Administration (FDA or Agency) is
ATSDR to prepare toxicological profiles
effects of glutaraldehyde for review and announcing the availability of the draft
for each substance included on the
potential inclusion in the profile. guidance entitled ‘‘List of Highest
priority list of hazardous substances
Comments can include additional Priority Devices for Human Factors
[also called the Substance Priority List
information or reports on studies about Review.’’ FDA is issuing this draft
(SPL)]. This list identifies 275
the health effects of glutaraldehyde. guidance document in order to inform
hazardous substances that ATSDR (in
Although ATSDR will consider key medical device manufacturers which
cooperation with EPA) has determined
studies for this substance during the device types should have human factors
pose the most significant potential
profile development process, this data included in premarket
threat to human health. The 2015 SPL
Federal Register notice solicits any submissions. FDA believes these device
is available online at
relevant, additional studies, particularly types have clear potential for serious
www.atsdr.cdc.gov/spl.
unpublished data. ATSDR will evaluate In addition, ATSDR has the authority harm resulting from use error and that
the quality and relevance of such data to prepare toxicological profiles for review of human factors data in
or studies for possible inclusion into the substances not found at sites on the premarket submissions will help FDA
profile. ATSDR is providing a public National Priorities List, in an effort to evaluate the safety and effectiveness and
comment period for this document as a ‘‘establish and maintain inventory of substantial equivalence of these devices.
means to best serve public health and literature, research, and studies on the This draft guidance is not final nor is it
our clients. health effects of toxic substances’’ under in effect at this time.
DATES: Written comments on this draft CERCLA Section 104(i)(1)(B), to respond DATES: Although you can comment on
Toxicological Profile must be received to requests for consultation under any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency
mstockstill on DSK4VPTVN1PROD with NOTICES
on or before May 3, 2016. section 104(i)(4), and as otherwise
ADDRESSES: You may submit comments, necessary to support the site-specific considers your comment of this draft
identified by docket number ATSDR– response actions conducted by ATSDR. guidance before it begins work on the
2016–0001, by any of the following The public comments and other data final version of the guidance, submit
methods: submitted in response to the Federal either electronic or written comments
• Federal eRulemaking Portal: Register notices are available for public on the draft guidance by May 3, 2016.
www.regulations.gov. Follow the inspection at ATSDR. Comments are ADDRESSES: You may submit comments
instructions for submitting comments. available for public inspection from as follows:
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Document Created: 2016-02-03 00:40:37
Document Modified: 2016-02-03 00:40:37
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Proposed consent agreement. | |
| Dates | Comments must be received on or before February 29, 2016. | |
| Contact | Evan Zullow (202) 326-2914 or Courtney Estep (202) 326-2788, Bureau of Consumer Protection, 600 Pennsylvania Avenue NW., Washington, DC 20580. | |
| FR Citation | 81 FR 5754 |
2025 Federal Register | Disclaimer | Privacy Policy
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