83 FR 63146 - National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Tomah Armory Landfill Superfund Site

ENVIRONMENTAL PROTECTION AGENCY

Federal Register Volume 83, Issue 235 (December 7, 2018)

Page Range		63146-63147
FR Document		2018-26492

The Environmental Protection Agency (EPA) Region 5 is issuing a Notice of Intent to Delete the Tomah Armory Landfill Superfund Site (Tomah Armory Site), located in Tomah, Wisconsin, from the National Priorities List (NPL) and requests public comments on this proposed action. The NPL, promulgated pursuant to Section 105 of the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA) of 1980, as amended, is an appendix of the National Oil and Hazardous Substances Pollution Contingency Plan (NCP). EPA and the State of Wisconsin, through the Wisconsin Department of Natural Resources (WDNR), have determined that all appropriate response actions under CERCLA, other than operation and maintenance, monitoring and five-year reviews, have been completed. However, this deletion does not preclude future actions under Superfund.

Federal Register, Volume 83 Issue 235 (Friday, December 7, 2018)

[Federal Register Volume 83, Number 235 (Friday, December 7, 2018)]
[Proposed Rules]
[Pages 63146-63147]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2018-26492]


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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1987-0002; FRL-9987-15-Region 5]


National Oil and Hazardous Substances Pollution Contingency Plan; 
National Priorities List: Deletion of the Tomah Armory Landfill 
Superfund Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; notification of intent.

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

SUMMARY: The Environmental Protection Agency (EPA) Region 5 is issuing 
a Notice of Intent to Delete the Tomah Armory Landfill Superfund Site 
(Tomah Armory Site), located in Tomah, Wisconsin, from the National 
Priorities

[[Page 63147]]

List (NPL) and requests public comments on this proposed action. The 
NPL, promulgated pursuant to Section 105 of the Comprehensive 
Environmental Response, Compensation, and Liability Act (CERCLA) of 
1980, as amended, is an appendix of the National Oil and Hazardous 
Substances Pollution Contingency Plan (NCP). EPA and the State of 
Wisconsin, through the Wisconsin Department of Natural Resources 
(WDNR), have determined that all appropriate response actions under 
CERCLA, other than operation and maintenance, monitoring and five-year 
reviews, have been completed. However, this deletion does not preclude 
future actions under Superfund.

DATES: Comments must be received by January 7, 2019.

ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-1987-0002, by mail to Randolph Cano, NPL Deletion Coordinator, 
U.S. Environmental Protection Agency Region 5 (SR-6J), 77 West Jackson 
Boulevard, Chicago, IL 60604. Comments may also be submitted 
electronically or through hand delivery/courier by following the 
detailed instructions in the ADDRESSES section of the direct final rule 
located in the ``Rules and Regulations'' section of this Federal 
Register.

FOR FURTHER INFORMATION CONTACT: Randolph Cano, NPL Deletion 
Coordinator, U.S. Environmental Protection Agency Region 5 (SR-6J), 77 
West Jackson Boulevard, Chicago, IL 60604, (312) 886-6036, email: 
[email protected].

SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' section of 
today's Federal Register, we are publishing a direct final Notice of 
Deletion of the Tomah Armory Superfund Site without prior Notice of 
Intent to Delete because EPA views this as a noncontroversial revision 
and anticipates no adverse comment. We have explained our reasons for 
this deletion in the preamble to the direct final Notice of Deletion, 
and those reasons are incorporated herein. If we receive no adverse 
comment(s) on this deletion action, we will not take further action on 
this Notice of Intent to Delete. If we receive adverse comment(s), we 
will withdraw the direct final Notice of Deletion, and it will not take 
effect. We will, as appropriate, address all public comments in a 
subsequent final Notice of Deletion based on this Notice of Intent to 
Delete. We will not institute a second comment period on this Notice of 
Intent to Delete. Any parties interested in commenting must do so at 
this time.
    For additional information, see the direct final Notice of Deletion 
which is located in the ``Rules and Regulations'' section of this 
Federal Register.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals, 
Hazardous waste, Hazardous substances, Intergovernmental relations, 
Penalties, Reporting and recordkeeping requirements, Superfund, Water 
pollution control, Water supply.

    Authority: 33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626, 
77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3 
CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp., 
p. 193.

    Dated: October 30, 2018.
Cathy Stepp,
Regional Administrator, Region 5.
[FR Doc. 2018-26492 Filed 12-6-18; 8:45 am]
BILLING CODE 6560-50-P

63146 Federal Register / Vol. 83, No. 235 / Friday, December 7, 2018 / Proposed Rules

or an order declining the De Novo none of the reasons in paragraph (b) of that the rights or safety of human
request under 860.289(b). this section for declining the De Novo subjects were not adequately protected
(b) A requester may supplement or request applies. or the supporting data were determined
amend a pending De Novo request to (2) If FDA grants a De Novo request, to be otherwise unreliable;
revise existing information or provide FDA will subsequently publish in the (10) A clinical or nonclinical study
additional information. Federal Register a notice of the necessary to demonstrate that general
(1) FDA may require additional classification order, including any controls or general and special controls
information regarding the device that is special controls. provide reasonable assurance of safety
necessary for FDA to complete the (b) FDA may issue written notice to and effectiveness:
review of the De Novo request. the requester declining a De Novo (i) Has not been completed per the
(2) Additional information submitted request if the requester fails to follow study protocol, or
to FDA must include the reference the requirements of this part or if, upon (ii) Deficiencies related to the
number assigned to the original De the basis of the information submitted investigation and identified in any
Novo request and, if submitted on the in the De Novo request or any other request for additional information under
requester’s own initiative, the reason for information before FDA, FDA § 860.256(b)(1) have not been
submitting the additional information. determines: adequately addressed; or
(c) Prior to granting or declining a De (1) The device does not meet the (11) After a De Novo request is
Novo request, FDA may inspect relevant criteria under section 513(a)(1) of the accepted for review under § 860.245(b),
facilities to help determine: Federal Food, Drug, and Cosmetic Act the requester makes significant
(1) That clinical or nonclinical data and § 860.3 for classification into class unsolicited changes to the device’s:
were collected in a manner that ensures I or II; (i) Indications for use; or
that the data accurately represents the (2) The De Novo request contains a (ii) Technological characteristics.
benefits and risks of the device; or false statement of material fact or there (c) An order declining a De Novo
(2) That implementation of Quality is a material omission; request will inform the requester of the
System Regulation (part 820 of this (3) The device’s labeling does not deficiencies in the De Novo request,
chapter) requirements, in addition to comply with the requirements in parts including each applicable ground for
other general controls and any specified 801 and 809 of this chapter, as declining the De Novo request.
special controls, provide adequate applicable; (d) FDA will use the criteria specified
assurance that critical and/or novel (4) The product described in the De in § 860.7 to determine the safety and
manufacturing processes produce Novo request does not meet the effectiveness of a device in deciding
devices that meet specifications definition of a device under section whether to grant or decline a De Novo
necessary to ensure reasonable 201(h) of the Federal Food, Drug, and request. FDA may use information other
assurance of safety and effectiveness. Cosmetic Act and is not a combination than that submitted by the requester in
§ 860.267 Withdrawal of a De Novo
product as defined at § 3.2(e) of this making such determination.
request. chapter; ■ 6. In part 860, remove all references to
(5) The device is of a type which has
(a) FDA will consider a De Novo ‘‘the act’’ and add in their place ‘‘the
already been approved in existing
request to have been withdrawn if: Federal Food, Drug, and Cosmetic Act’’.
(1) The requester fails to provide a applications for premarket approval
(PMAs) submitted under part 814 of this Dated: November 27, 2018.
complete response to a request for Scott Gottlieb,
additional information pursuant to chapter;
(6) The device is of a type that has Commissioner of Food and Drugs.
§ 860.256(b)(1) within 180 days after the
already been classified into class I, class [FR Doc. 2018–26378 Filed 12–4–18; 8:45 am]
date FDA issues such request;
(2) The requester fails to provide a II, or class III; BILLING CODE 4164–01–P
(7) An inspection of a relevant facility
complete response to the deficiencies
under § 860.256(c) results in a
identified by FDA pursuant to
determination that general or general ENVIRONMENTAL PROTECTION
§ 860.245(c)(2) within 180 days of the
and special controls would not provide AGENCY
date notification was issued by FDA;
(3) The requester does not permit an reasonable assurance of safety and
authorized FDA employee an effectiveness; 40 CFR Part 300
(8) A nonclinical laboratory study that
opportunity to inspect the facilities, [EPA–HQ–SFUND–1987–0002; FRL–9987–
is described in the De Novo request, and
pursuant to § 860.256(c), at a reasonable 15–Region 5]
that is essential to show there is
time and in a reasonable manner, and to
reasonable assurance of safety was not National Oil and Hazardous
have access to copy and verify all
conducted in compliance with the good Substances Pollution Contingency
records pertinent to the De Novo
laboratory practice regulations in part Plan; National Priorities List: Deletion
request; or
(4) The requester submits a written 58 of this chapter and no reason for the of the Tomah Armory Landfill
notice to FDA that the De Novo request noncompliance is provided or, if a Superfund Site
has been withdrawn. reason is provided, the practices used in
(b) If FDA considers a De Novo conducting the study do not support the AGENCY: Environmental Protection
request to be withdrawn, the Agency validity of the study; Agency (EPA).
will notify the requester. The notice will (9) A clinical investigation described ACTION: Proposed rule; notification of
amozie on DSK3GDR082PROD with PROPOSALS1

include the De Novo request reference in the De Novo request involving human intent.
number and the date FDA considered subjects that is subject to the
the De Novo request withdrawn. institutional review board regulations in SUMMARY: The Environmental Protection
part 56 of this chapter, informed Agency (EPA) Region 5 is issuing a
§ 860.289 Granting or declining a De Novo consent regulations in part 50 of this Notice of Intent to Delete the Tomah
request. chapter, or GCP described in 812.28(a) Armory Landfill Superfund Site (Tomah
(a)(1) FDA will issue to the requester of this chapter, was not conducted in Armory Site), located in Tomah,
an order granting a De Novo request if compliance with those regulations such Wisconsin, from the National Priorities

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$Federal Register / Vol. 83, No. 235 / Friday, December 7, 2018 / Proposed Rules 63147 List (NPL) and requests public hand delivery/courier by following the will, as appropriate, address all public comments on this proposed action. The detailed instructions in the ADDRESSES comments in a subsequent final Notice NPL, promulgated pursuant to Section section of the direct final rule located in of Deletion based on this Notice of 105 of the Comprehensive the ‘‘Rules and Regulations’’ section of Intent to Delete. We will not institute a Environmental Response, this Federal Register. second comment period on this Notice Compensation, and Liability Act FOR FURTHER INFORMATION CONTACT: of Intent to Delete. Any parties (CERCLA) of 1980, as amended, is an Randolph Cano, NPL Deletion interested in commenting must do so at appendix of the National Oil and Coordinator, U.S. Environmental this time. Hazardous Substances Pollution Protection Agency Region 5 (SR–6J), 77 For additional information, see the Contingency Plan (NCP). EPA and the West Jackson Boulevard, Chicago, IL direct final Notice of Deletion which is State of Wisconsin, through the 60604, (312) 886–6036, email: located in the ‘‘Rules and Regulations’’ Wisconsin Department of Natural cano.randolph@epa.gov. section of this Federal Register. Resources (WDNR), have determined SUPPLEMENTARY INFORMATION: In the List of Subjects in 40 CFR Part 300 that all appropriate response actions ‘‘Rules and Regulations’’ section of Environmental protection, Air under CERCLA, other than operation today’s Federal Register, we are pollution control, Chemicals, Hazardous and maintenance, monitoring and five- publishing a direct final Notice of waste, Hazardous substances, year reviews, have been completed. Deletion of the Tomah Armory Intergovernmental relations, Penalties, However, this deletion does not Superfund Site without prior Notice of Reporting and recordkeeping preclude future actions under Intent to Delete because EPA views this requirements, Superfund, Water Superfund. as a noncontroversial revision and pollution control, Water supply. DATES: Comments must be received by anticipates no adverse comment. We January 7, 2019. have explained our reasons for this Authority: 33 U.S.C. 1321(d); 42 U.S.C. deletion in the preamble to the direct 9601–9657; E.O. 13626, 77 FR 56749, 3 CFR, ADDRESSES: Submit your comments, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, identified by Docket ID no. EPA–HQ– final Notice of Deletion, and those 3 CFR, 1991 Comp., p. 351; E.O. 12580, 52 SFUND–1987–0002, by mail to reasons are incorporated herein. If we FR 2923, 3 CFR, 1987 Comp., p. 193. Randolph Cano, NPL Deletion receive no adverse comment(s) on this Coordinator, U.S. Environmental deletion action, we will not take further Dated: October 30, 2018. Protection Agency Region 5 (SR–6J), 77 action on this Notice of Intent to Delete. Cathy Stepp, West Jackson Boulevard, Chicago, IL If we receive adverse comment(s), we Regional Administrator, Region 5. 60604. Comments may also be will withdraw the direct final Notice of [FR Doc. 2018–26492 Filed 12–6–18; 8:45 am] submitted electronically or through Deletion, and it will not take effect. We BILLING CODE 6560–50–P amozie on DSK3GDR082PROD with PROPOSALS1 VerDate Sep<11>2014 16:06 Dec 06, 2018 Jkt 247001 PO 00000 Frm 00038 Fmt 4702 Sfmt 9990 E:\FR\FM\07DEP1.SGM 07DEP1$

Document Created: 2018-12-07 01:52:39
Document Modified: 2018-12-07 01:52:39

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		Proposed Rules
Action		Proposed rule; notification of intent.
Dates		Comments must be received by January 7, 2019.
Contact		Randolph Cano, NPL Deletion Coordinator, U.S. Environmental Protection Agency Region 5 (SR-6J), 77 West Jackson Boulevard, Chicago, IL 60604, (312) 886-6036, email: [email protected]
FR Citation		83 FR 63146
CFR Associated		Environmental Protection; Air Pollution Control; Chemicals; Hazardous Waste; Hazardous Substances; Intergovernmental Relations; Penalties; Reporting and Recordkeeping Requirements; Superfund; Water Pollution Control and Water Supply