National Oil and Hazardous Substances Pollution Contingency Plan; National Priorities List: Deletion of the Jackson Steel Superfund Site, 53380-53381 [2016-19142]
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Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Proposed Rules
trifluoromethylnicotinamide (IUPAC)]
and its metabolites, TFNA [4trifluoromethylnicotinic acid], TFNA–
AM [4-trifluoromethylnicotinamide)
and TFNG [N(4trifluoromethylnicotinoyl)-glycine] in or
on the raw agricultural commodity crop
group 10–10, citrus at 1.5 parts per
million (ppm). Adequate enforcement
methodology is available to enforce the
tolerance expression for flonicamid and
its metabolites in/on appropriate raw
agricultural commodities and processed
commodities are available for the
established and proposed tolerances.
Contact: Carmen Rodia, (703) 306–0327,
rodia.carmen@epa.gov.
2. PP 6E8466. (EPA–HQ–OPP–2016–
0029). Gowan Company, P.O. Box 5569,
Yuma, AZ 85366–5569, requests to
establish an import tolerance for
residues of fenazaquin, [3-[2-[4-(1, 1dimethylethyl) phenyl] ethoxy]
quinazoline] in/on the raw agricultural
commodity for tea at 9 ppm and
pineapple at 0.2 ppm. The analytical
method for the analysis of fenazaquin
in/on tea was conducted by GC–MS in
selected ion monitoring mode. The
analytical method used for the
determination of fenazaquin in or on
pineapple was conducted by UPLC
employing mass spectrometric detection
(LC–MS/MS). Contact: Carmen Rodia,
(703) 306–0327, rodia.carmen@epa.gov.
3. PP 6F8468. (EPA–HQ–OPP–2016–
0416). BASF Corporation, 26 Davis
Drive, P.O. Box 13528, Research
Triangle Park, NC 27709–3528, requests
to establish a tolerance for residues of
the insecticide afidopyropen,
[(3S,4R,4aR,6S, 6aS, 12R,12aS,12bS)-3(cyclopropanecarbonyloxy)-6,12dihydroxy-4,6a,12b-trimethyl-11-oxo-9(pyridin-3-yl)-1,2,3,4,4a,5,6,6a,12a,12bdecahydro-11H,12Hbenzo[ƒ]pyrano[4,3-b]chromen-4yl]methyl cyclopropanecarboxylate, its
metabolites, and degradates, in or on the
raw agricultural commodities almond
hulls at 0.15 ppm; apple, wet pomace at
0.05 ppm; citrus oil at 0.3 ppm; cotton,
gin byproducts at 2 ppm; cotton,
undelinted seed at 0.1 ppm; fruit, citrus,
group 10–10 at 0.15 ppm; fruit, pome,
group 11–10 at 0.03 ppm; fruit, stone,
group 12–12 at 0.03 ppm; nut, tree,
group 14–12 at 0.01 ppm; plum, prune
at 0.06 ppm; soybean, aspirated
fractions at 0.4 ppm; soybean, forage at
label restriction ppm; soybean, hay at
label restriction ppm; soybean, seed at
0.01 ppm; vegetable, brassica, head and
stem group 5–13 at 0.5 ppm; vegetable,
cucurbit, group 9 at 0.7 ppm; vegetable,
fruiting, group 8–10 at 0.15 ppm;
vegetable, leaf petioles, subgroup 22B at
3 ppm; vegetable, leafy, subgroup 4–13A
at 2 ppm; vegetable leafy, subgroup 4–
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13B at 5 ppm; and vegetable tuberous
and corm, subgroup 1C at 0.01 ppm.
An independently validated
analytical method has been submitted
for analyzing residues of parent
afidopyropen (BAS 440 I) plus
metabolite M440I007 with appropriate
sensitivity in all crop and processed
commodities. An independently
validated analytical method has been
submitted for analyzing residues of
parent afidopyropen (BAS 440 I) plus
metabolite M440I001, M440I003, and
M440I060 in animal meat, fat and liver
and egg and for BAS 440 I and
metabolites M440I001, M440I005, and
M440I060 in milk with appropriate
sensitivity in the event tolerances are
established. A multi-residue method
using modified AOAC Official method
2007.01 for the determination of
residues of afidopyropen (BAS 440 I)
and metabolite M440I007 in plant
matrices was successfully validated.
Contact: Carmen Rodia, (703) 306–0327,
rodia.carmen@epa.gov.
4. PP 6E8463. (EPA–HQ–OPP–2007–
0099). Nichino America, Inc., 4550 New
Linden Hill Road, Suite 501,
Wilmington, DE 19808–2951, requests
to establish an import tolerance for
residues of flubendiamide, N2-[1,1dimethyl-2-(methylsulfonyl)ethyl-3iodo-N1-[2-methyl-4-[1,2,2,2-tetrafluoro1-(trifluoromethyl)ethyl]phenyl]-1,2benzenedicarboxamide, in/on the
processed commodity dried tea at 60
ppm. Independently validated,
analytical methods for crop matrices
have been submitted for measuring
flubendiamide. Typically, plant
matrices samples are extracted,
concentrated, and quantified by LC/MS/
MS using deuterated internal standards.
Contact: Carmen Rodia, (703) 306–0327,
rodia.carmen@epa.gov.
Authority: 21 U.S.C. 346a.
Dated: August 5, 2016.
Daniel J. Rosenblatt,
Acting Director, Registration Division, Office
of Pesticide Programs.
[FR Doc. 2016–19239 Filed 8–11–16; 8:45 am]
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ENVIRONMENTAL PROTECTION
AGENCY
40 CFR Part 300
[EPA–HQ–SFUND–2000–0006; FRL–9950–
61–Region 2]
National Oil and Hazardous
Substances Pollution Contingency
Plan; National Priorities List: Deletion
of the Jackson Steel Superfund Site
Environmental Protection
Agency (EPA).
ACTION: Proposed rule; notice of intent
for deletion.
AGENCY:
The Environmental Protection
Agency (EPA), Region 2, is issuing this
Notice of Intent to Delete (NOID) the
Jackson Steel Site, located in the Village
of Mineola, Nassau County, New York,
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. EPA and the State of
New York, through the New York State
Department of Environmental
Conservation (NYSDEC), have
determined that other than the ongoing
operation and maintenance of the vapor
intrusion mitigation systems at the
daycare center, periodic vapor intrusion
monitoring, ensuring that the
institutional controls are in place and
effective, and five-year reviews, all
appropriate response actions under
CERCLA have been completed at the
Site and that the soil on the Site and the
groundwater beneath the Site no longer
pose a threat to public health or the
environment.
SUMMARY:
Comments must be received by
September 12, 2016.
ADDRESSES: Submit your comments,
identified by Docket ID no. EPA–HQ–
SFUND–2000–0006, by mail to Joel
Singerman, Chief, Central New York
Remediation Section, Emergency and
Remedial Response Division, U.S.
Environmental Protection Agency,
Region 2, 290 Broadway, 20th Floor,
New York, NY, 10007–1866. 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 section of
this Federal Register.
FOR FURTHER INFORMATION CONTACT: Joel
Singerman at the address noted in the
ADDRESSES section; by telephone at 212–
DATES:
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Federal Register / Vol. 81, No. 156 / Friday, August 12, 2016 / Proposed Rules
637–4258; or by email at
singerman.joel@epa.gov.
In the
‘‘Rules and Regulations’’ Section of
today’s Federal Register, EPA is
publishing a direct final Notice of
Deletion (NOD) of the Site without a
prior NOID because EPA views this as
a noncontroversial revision and
anticipates no adverse comment. EPA
has explained its reasons for this
deletion in the preamble to the direct
final NOD. If EPA receives no adverse
comment(s) on this deletion action, EPA
will proceed with the deletion without
further action on this NOID. If EPA
receives adverse comment(s), EPA will
withdraw the direct final NOD, and it
will not take effect. EPA will, as
appropriate, address all public
comments in a subsequent final NOD
based on this NOID. EPA will not
institute a second comment period on
this NOID. Any parties interested in
commenting must do so at this time.
For additional information, see the
direct final NOD, which is located in the
‘‘Rules’’ section of this Federal Register.
SUPPLEMENTARY INFORMATION:
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(c)(2); 42 U.S.C.
9601–9675; 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: August 2, 2016.
Judith A. Enck,
Regional Administrator, EPA Region.
[FR Doc. 2016–19142 Filed 8–11–16; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
42 CFR Part 10
RIN 0906–AA90
340B Drug Pricing Program;
Administrative Dispute Resolution
Health Resources and Services
Administration, HHS.
ACTION: Notice of proposed rulemaking.
ehiers on DSK5VPTVN1PROD with PROPOSALS
AGENCY:
The Health Resources and
Services Administration (HRSA)
implements section 340B of the Public
Health Service Act (PHSA), which is
referred to as the ‘‘340B Drug Pricing
Program’’ or the ‘‘340B Program.’’ This
proposed rule will apply to all drug
SUMMARY:
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manufacturers and covered entities that
participate in the 340B Program. The
proposed rule sets forth the
requirements and procedures for the
340B Program’s administrative dispute
resolution process.
DATES: Submit written comments on or
before October 11, 2016.
ADDRESSES: You may submit comments,
identified by the Regulatory Information
Number (RIN) 0906–AA90, by any of the
following methods. Please submit your
comments in only one of these ways to
minimize the receipt of duplicate
submissions.
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow
instructions for submitting comments.
This is the preferred method for the
submission of comments.
• Email: 340BNPRMADR@hrsa.gov.
Include 0906–AA90 in the subject line
of the message.
• Regular, express, or overnight mail:
CAPT Krista Pedley, Director, Office of
Pharmacy Affairs (OPA), Healthcare
Systems Bureau (HSB), HRSA, 5600
Fishers Lane, Mail Stop 08W05A,
Rockville, MD 20857. Please allow
sufficient time for mailed comments to
be received before the close of the
comment period.
All submitted comments will be
available to the public in their entirety.
All comments received may be posted
without change to https://
www.regulations.gov, including any
personally identifiable or confidential
business information that is included in
a comment.
FOR FURTHER INFORMATION CONTACT:
CAPT Krista Pedley, Director, OPA,
HSB HRSA, 5600 Fishers Lane, Mail
Stop 08W05A, Rockville, MD 20857, or
by telephone at 301–594–4353.
SUPPLEMENTARY INFORMATION: The
President encourages Federal agencies
through Executive Order 13563 to
develop balanced regulations by
encouraging broad public participation
in the regulatory process and an open
exchange of ideas. Accordingly, the
Department of Health and Human
Services (HHS or the Department) urges
all interested parties to examine this
regulatory proposal carefully and to
share your views with us, including any
data to support your positions. If you
have questions before submitting
comments, please see the FOR FURTHER
INFORMATION CONTACT field above for the
name and contact information of the
subject-matter expert involved in the
development of this proposal. We will
consider all written comments received
during the comment period before
issuing a final rule.
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53381
If you are a person with a disability
and/or a user of assistive technology
who has difficulty accessing this
document, please contact HRSA’s
Regulations Officer at: Room 13N82,
5600 Fishers Lane, Rockville, MD
20857; or by telephone at 301–443–
1785, to obtain this information in an
accessible format. This is not a toll free
telephone number.
Please visit https://www.HHS.gov/
regulations for more information on
HHS rulemaking and opportunities to
comment on proposed and existing
rules.
I. Background
Section 602 of Public Law 102–585,
the ‘‘Veterans Health Care Act of 1992,’’
enacted section 340B of the PHSA
entitled ‘‘Limitation on Prices of Drugs
Purchased by Covered Entities,’’ which
was codified at 42 U.S.C. 256b. The
340B Program permits covered entities
‘‘to stretch scarce Federal resources as
far as possible, reaching more eligible
patients and providing more
comprehensive services.’’ H.R. REP. No.
102–384(II), at 12 (1992). The Secretary
of the HHS delegated the authority to
operate section 340B of the PHSA to the
Administrator of HRSA. Pursuant to this
delegation of authority, HRSA
established and administers the 340B
Program. Operationally, the 340B
Program is housed within HRSA’s
Healthcare Systems Bureau (HSB),
Office of Pharmacy Affairs (OPA).
Eligible covered entity types are defined
in section 340B(a)(4) of the PHSA, as
amended. Section 340B of the PHSA
instructs HHS to enter into
pharmaceutical pricing agreements
(PPA) with manufacturers of covered
outpatient drugs. Manufacturers are
required by section 1927(a)(5)(A) of the
Social Security Act to enter into
agreements with the Secretary of HHS
that comply with section 340B of the
PHSA if they participate in the
Medicaid Drug Rebate Program. When a
drug manufacturer signs a PPA, it agrees
that the prices charged for covered
outpatient drugs to covered entities will
not exceed defined 340B ceiling prices,
which are based on quarterly pricing
data reported by manufacturers to the
Centers for Medicare & Medicaid
Services (CMS).
Section 7102 of the Patient Protection
and Affordable Care Act (Pub. L. 111–
148), as amended by section 2302 of the
Health Care and Education
Reconciliation Act (Pub. L. 111–152),
hereinafter referred to as the
‘‘Affordable Care Act,’’ added section
340B(d)(3) of the PHSA, which requires
the Secretary of HHS (or the Secretary)
to promulgate a regulation establishing
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Agencies
[Federal Register Volume 81, Number 156 (Friday, August 12, 2016)]
[Proposed Rules]
[Pages 53380-53381]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19142]
-----------------------------------------------------------------------
ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 300
[EPA-HQ-SFUND-2000-0006; FRL-9950-61-Region 2]
National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Jackson Steel Superfund Site
AGENCY: Environmental Protection Agency (EPA).
ACTION: Proposed rule; notice of intent for deletion.
-----------------------------------------------------------------------
SUMMARY: The Environmental Protection Agency (EPA), Region 2, is
issuing this Notice of Intent to Delete (NOID) the Jackson Steel Site,
located in the Village of Mineola, Nassau County, New York, 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. EPA and the State of
New York, through the New York State Department of Environmental
Conservation (NYSDEC), have determined that other than the ongoing
operation and maintenance of the vapor intrusion mitigation systems at
the daycare center, periodic vapor intrusion monitoring, ensuring that
the institutional controls are in place and effective, and five-year
reviews, all appropriate response actions under CERCLA have been
completed at the Site and that the soil on the Site and the groundwater
beneath the Site no longer pose a threat to public health or the
environment.
DATES: Comments must be received by September 12, 2016.
ADDRESSES: Submit your comments, identified by Docket ID no. EPA-HQ-
SFUND-2000-0006, by mail to Joel Singerman, Chief, Central New York
Remediation Section, Emergency and Remedial Response Division, U.S.
Environmental Protection Agency, Region 2, 290 Broadway, 20th Floor,
New York, NY, 10007-1866. 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 section of this Federal Register.
FOR FURTHER INFORMATION CONTACT: Joel Singerman at the address noted in
the ADDRESSES section; by telephone at 212-
[[Page 53381]]
637-4258; or by email at singerman.joel@epa.gov.
SUPPLEMENTARY INFORMATION: In the ``Rules and Regulations'' Section of
today's Federal Register, EPA is publishing a direct final Notice of
Deletion (NOD) of the Site without a prior NOID because EPA views this
as a noncontroversial revision and anticipates no adverse comment. EPA
has explained its reasons for this deletion in the preamble to the
direct final NOD. If EPA receives no adverse comment(s) on this
deletion action, EPA will proceed with the deletion without further
action on this NOID. If EPA receives adverse comment(s), EPA will
withdraw the direct final NOD, and it will not take effect. EPA will,
as appropriate, address all public comments in a subsequent final NOD
based on this NOID. EPA will not institute a second comment period on
this NOID. Any parties interested in commenting must do so at this
time.
For additional information, see the direct final NOD, which is
located in the ``Rules'' 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(c)(2); 42 U.S.C. 9601-9675; 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: August 2, 2016.
Judith A. Enck,
Regional Administrator, EPA Region.
[FR Doc. 2016-19142 Filed 8-11-16; 8:45 am]
BILLING CODE 6560-50-P