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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
The plat representing the dependent
resurvey of Homestead Entry Survey No.
234, Township 2 South, Range 31 East,
accepted June 17, 2015, and officially
filed June 18, 2015, for Group 1139,
Arizona.
This plat was prepared at the request
of the United States Forest Service.
A person or party who wishes to
protest against any of these surveys
must file a written protest with the
Arizona State Director, Bureau of Land
Management, stating that they wish to
protest.
A statement of reasons for a protest
may be filed with the notice of protest
to the State Director, or the statement of
reasons must be filed with the State
Director within thirty (30) days after the
protest is filed.
FOR FURTHER INFORMATION CONTACT:
These plats will be available for
inspection in the Arizona State Office,
Bureau of Land Management, One North
Central Avenue, Suite 800, Phoenix,
Arizona, 85004–4427. Persons who use
a telecommunications device for the
deaf (TDD) may call the Federal
Information Relay Service (FIRS) at 1–
800–877–8339 to contact the above
individual during normal business
hours. The FIRS is available 24 hours a
day, 7 days a week, to leave a message
or question with the above individual.
You will receive a reply during normal
business hours.
Gerald T. Davis,
Chief Cadastral Surveyor of Arizona.
[FR Doc. 2015–16679 Filed 7–7–15; 8:45 am]
BILLING CODE 4310–32–P
DEPARTMENT OF THE INTERIOR
Bureau of Land Management
[LLCON02000.L16100000.DR0000]
Notice of Availability of the Kremmling
Field Office Record of Decision and
Approved Resource Management Plan,
Colorado
AGENCY:
Bureau of Land Management,
Interior.
Notice.
ACTION:
The Bureau of Land
Management (BLM) announces the
availability of the Record of Decision
(ROD) and approved Resource
Management Plan (RMP) for the
Kremmling Field Office located in
Grand, Eagle, Summit, Jackson, Larimer,
and Routt counties in northwest
Colorado. The Colorado State Director
signed the ROD on June 19, 2015, which
constitutes the BLM’s final decision and
srobinson on DSK5SPTVN1PROD with NOTICES
SUMMARY:
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18:49 Jul 07, 2015
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makes the approved RMP effective
immediately.
ADDRESSES: Copies of the ROD/
approved RMP are available upon
request from the Field Manager, BLM
Kremmling Field Office, 2103 E. Park
Ave, Kremmling CO 80459 or via the
Internet at http://www.blm.gov/co/st/en/
fo/kfo.html. Copies of the ROD/
approved RMP are available for public
inspection at the Kremmling Field
Office.
FOR FURTHER INFORMATION CONTACT:
Stephanie Odell, Field Manager;
telephone 970–724–3001; address 2103
E. Park Ave, Kremmling CO 80459;
email sodell@blm.gov. Persons who use
a telecommunications device for the
deaf (TDD) may call the Federal
Information Relay Service (FIRS) at 1–
800–877–8339 to contact Ms. Odell
during normal business hours. The FIRS
is available 24 hours a day, seven days
a week, to leave a message or question
for Ms. Odell. You will receive a reply
during normal business hours.
SUPPLEMENTARY INFORMATION: The
approved RMP provides management
for approximately 377,900 BLMadministered surface acres and 653,500
acres of mineral estate in northwest
Colorado. It describes the actions
needed to meet the desired resource
conditions for upland and riparian
vegetation, fish and wildlife habitats,
water resources, air quality, cultural,
paleontological and visual resources as
well as livestock grazing, minerals,
energy development, and recreation.
While the approved RMP also proposes
some conservation management for
Greater Sage-Grouse habitat, the
Northwest Colorado BLM Greater SageGrouse Plan Amendment and
Environmental Impact Statement (EIS)
will fully analyze applicable Greater
Sage-Grouse conservation measures.
The BLM expects to make a
comprehensive set of decisions for
managing Greater Sage-Grouse on land
administered by the Kremmling Field
Office in the Record of Decision for the
Northwest Colorado BLM Greater SageGrouse Plan Amendment and EIS,
which when final will amend this RMP.
The BLM initiated scoping for the
RMP in 2007, and collected information
and public input via public meetings
and interviews in order to develop the
draft RMP/EIS in September 2011.
Based on public comments, the BLM
made edits and carried forward the
preferred alternative into the proposed
RMP/final EIS with some modifications.
The Environmental Protection Agency
and the BLM published their respective
Notices of Availability of the proposed
RMP/final EIS in the Federal Register
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on March 21, 2014 (79 FR 15741 and
15772), initiating the protest period.
During the protest period for the
proposed RMP, the BLM received five
valid protest submissions. All protests
were dismissed; however, the BLM
made minor editorial modifications to
the approved RMP to provide further
clarification of some of the decisions.
There was also a 60-day Governor’s
consistency review period for the
proposed RMP; no inconsistencies were
identified during the review.
The decisions designating routes of
travel for motorized vehicles are
implementation decisions and are
appealable under 43 CFR part 4. These
decisions are contained in Appendix A
of the approved RMP. These route
designations will be evaluated for
consistency with the Northwest
Colorado BLM Greater Sage-Grouse Plan
Amendment and EIS, when final; and if
needed, additional NEPA will occur,
with public involvement, to address any
inconsistencies. Any party adversely
affected by the proposed route
designations may appeal within 30 days
of publication of this Notice of
Availability pursuant to 43 CFR part 4,
subpart E. The appeal should state the
specific route(s), as identified in
Appendix A of the approved RMP, on
which the decision is being appealed.
The appeal must be filed with the
Kremmling Field Manager at the above
listed address. Please consult the
appropriate regulations (43 CFR part 4,
subpart E) for further appeal
requirements.
Authority: 40 CFR 1506.6.
Ruth Welch,
BLM Colorado State Director.
[FR Doc. 2015–16432 Filed 7–7–15; 8:45 am]
BILLING CODE 4310–JB–P
DEPARTMENT OF THE INTERIOR
Bureau of Safety and Environmental
Enforcement
[Docket ID BSEE–2015–0010; OMB Control
Number 1014–0017; 15XE1700DX
EEEE500000 EX1SF0000.DAQ000]
Information Collection Activities:
Safety and Environmental Management
Systems (SEMS); Proposed Collection;
Comment Request
ACTION:
60-day notice.
To comply with the
Paperwork Reduction Act of 1995
(PRA), BSEE is inviting comments on a
collection of information that we will
submit to the Office of Management and
Budget (OMB) for review and approval.
SUMMARY:
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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
The information collection request (ICR)
concerns a renewal to the paperwork
requirements in the regulations under
Subpart S, Safety and Environmental
Management Systems (SEMS).
DATES: You must submit comments by
September 8, 2015.
ADDRESSES: You may submit comments
by either of the following methods listed
below.
• Electronically go to http://
www.regulations.gov. In the Search box,
enter BSEE–2015–0010 then click
search. Follow the instructions to
submit public comments and view all
related materials. We will post all
comments.
• Email cheryl.blundon@bsee.gov.
Mail or hand-carry comments to the
Department of the Interior; Bureau of
Safety and Environmental Enforcement;
Regulations and Standards Branch;
ATTN: Cheryl Blundon; 45600
Woodland Road, Sterling, VA 20166.
Please reference ICR 1014–0017 in your
comment and include your name and
return address.
FOR FURTHER INFORMATION CONTACT:
Cheryl Blundon, Regulations and
Standards Branch at (703) 787–1607 to
request additional information about
this ICR.
SUPPLEMENTARY INFORMATION:
Title: 30 CFR part 250, subpart S,
Safety and Environmental management
Systems (SEMS).
Form(s): BSEE–0131.
OMB Control Number: 1014–0017.
Abstract: The Outer Continental Shelf
(OCS) Lands Act at 43 U.S.C. 1334
authorizes the Secretary of the Interior
(Secretary) to prescribe rules and
regulations necessary for the
administration of the leasing provisions
of that Act related to mineral resources
on the OCS. Such rules and regulations
will apply to all operations conducted
under a lease. Operations on the OCS
must preserve, protect, and develop oil
and natural gas resources in a manner
that is consistent with the need to make
such resources available to meet the
Nation’s energy needs as rapidly as
possible; to balance orderly energy
resource development with protection
of human, marine, and coastal
environments; to ensure the public a fair
and equitable return on the resources of
the OCS; and to preserve and maintain
free enterprise competition. These
responsibilities are among those
delegated to the Bureau of Safety and
Environmental Enforcement (BSEE).
In addition to the general rulemaking
authority of the OCSLA at 43 U.S.C.
1334, section 301(a) of the Federal Oil
and Gas Royalty Management Act
(FOGRMA), 30 U.S.C. 1751(a), grants
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18:49 Jul 07, 2015
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authority to the Secretary to prescribe
such rules and regulations as are
reasonably necessary to carry out
FOGRMA’s provisions. While the
majority of FOGRMA is directed to
royalty collection and enforcement,
some provisions apply to offshore
operations. For example, section 108 of
FOGRMA, 30 U.S.C. 1718, grants the
Secretary broad authority to inspect
lease sites for the purpose of
determining whether there is
compliance with the mineral leasing
laws. Section 109(c)(2) and (d)(1), 30
U.S.C. 1719(c)(2) and (d)(1), impose
substantial civil penalties for failure to
permit lawful inspections and for
knowing or willful preparation or
submission of false, inaccurate, or
misleading reports, records, or other
information. Because the Secretary has
delegated some of the authority under
FOGRMA to BSEE, 30 U.S.C. 1751 is
included as additional authority for
these requirements.
Regulations governing Safety and
Environmental Management Systems
(SEMS) are covered in 30 CFR 250,
Subpart S and are the subject of this
collection. This request also covers any
related Notices to Lessees and Operators
(NTLs) that BSEE issues to clarify,
supplement, or provide additional
guidance on some aspects of our
regulations.
We consider the information to be
critical for us to monitor industry’s
operations record of safety and
environmental management of the OCS.
The Subpart S regulations hold the
operator accountable for the overall
safety of the offshore facility, including
ensuring that all employees, contractors,
and subcontractors have safety policies
and procedures in place that support the
implementation of the operator’s SEMS
program and align with the principles of
managing safety. The SEMS program
describes management commitment to
safety and the environment, as well as
policies and procedures to assure safety
and environmental protection while
conducting OCS operations (including
those operations conducted by all
personnel on the facility). BSEE will use
the information obtained by submittals
and observed via SEMS audits to ensure
that operations on the OCS are
conducted safely, as they pertain to both
human and environmental factors, and
in accordance with BSEE regulations, as
well as industry practices. The UWA
and other recordkeeping will be
reviewed diligently by BSEE during
inspections/audits, etc., to ensure that
industry is correctly implementing the
documentation and that the
requirements are being followed
properly.
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39153
Information on Form BSEE–0131
includes company identification,
number of company/contractor injuries
and/or illnesses suffered, company/
contractor hours worked, EPA National
Pollutant Discharge Elimination System
(NPDES) permit noncompliances, and
oil spill volumes for spills less than 1
barrel. All pieces of information are
reported annually as collected during 1
calendar year and the information
broken out quarterly. The information is
used to develop industry average
incident rates that help to describe how
well the offshore oil and gas industry is
performing. Using the produced data
allows BSEE to better focus our
regulatory and research programs on
areas where the performance measures
indicate that operators are having
difficulty meeting our expectations.
BSEE will be more effective in
leveraging resources by redirecting
research efforts, promoting appropriate
regulatory initiatives, and shifting
inspection program emphasis based on
performance results.
However, this ICR has removed form
BSEE–0130. BSEE has found that there
have been no instances of organizations
using form BSEE–0130 and that
equivalent information can be submitted
by organizations following the
instructions in § 250.1922(a)(1), ‘‘. . .
submit documentation to BSEE
describing the process for assessing an
ASP for accreditation and approving,
maintaining, and withdrawing the
accreditation of an ASP.’’ BSEE’s Office
of Offshore Regulatory Programs will
then review the information, request
other supporting documents as needed,
and propose terms of BSEE oversight, in
order to ensure conformance with the
entirety of § 250.1922. Therefore, BSEE
believes the intent of the form BSEE–
0130 is already incorporated in the
regulations and will remove the
duplicate information collection burden
represented by form BSEE–0130.
No questions of a sensitive nature are
asked. We protect proprietary
information according to the Freedom of
Information Act (5 U.S.C. 552) and
DOI’s implementing regulations (43 CFR
2); 30 CFR 250.197, Data and
information to be made available to the
public or for limited inspection; and 30
CFR part 252, OCS Oil and Gas
Information Program. Responses are
mandatory.
Frequency: Varies by section but is
primarily on occasion.
Description of Respondents: Potential
respondents comprise Federal oil, gas,
or sulphur lessees and/or operators.
Estimated Reporting and
Recordkeeping Hour Burden: The
currently approved annual reporting
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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
burden for this collection is 651,728
hours and $9,444,000 non-hour cost
burdens. In this submission, we are
requesting a total of 2,238,164 burden
hours and $5,220,000 non-hour cost
burdens. The following chart details the
individual components and respective
hour burden estimates of this ICR. In
calculating the burdens, we assumed
that respondents perform certain
Citation 30 CFR 250 subpart S
Reporting and recordkeeping requirement +
1900–1933 ......................
High Activity Operator: Have a SEMS program, and maintain all documentation and records pertaining to your
SEMS program, according to API RP 75, ISO 17011 in
their entirety, the COS–2–01, 03, and 04 documents as
listed in § 250.198, and all the requirements as detailed in
30 CFR 250, Subpart S. Make your SEMS available to
BSEE upon request.
Moderate Activity Operator: Have a SEMS program, and
maintain all documentation and records pertaining to your
SEMS program, according to API RP 75, the three COS
documents in their entirety, and all the requirements as
detailed in 30 CFR 250, Subpart S. Make your SEMS
available to BSEE upon request.
Low Activity Operator: Have a SEMS program, and maintain
all documentation and records pertaining to your SEMS
program, according to API RP 75, the three COS documents in their entirety, and all the requirements as detailed in 30 CFR 250, Subpart S. Make your SEMS available to BSEE upon request.
Immediate supervisor must conduct a JSA, sign the JSA,
and ensure all personnel participating sign the JSA. The
individual designated as being in charge of facility approves and signs all JSAs before job starts. NOTE: If activity is repeated, the 1st signed JSA is allowed.
Submit Form BSEE–0131. Maintain a contractor employee
injury/illness log in the operation area, retain for 2 years,
and make available to BSEE upon request (this requirement is included in the form burden). Inform contractors
of hazards.
1900–1933 ......................
1900–1933 ......................
1911(b) ...........................
1914(e); 1928(d), (e);
1929.
1920(a), (b); 1921 ..........
ASP audit for High Activity Operator .....................................
ASP audit for Low Activity Operator ......................................
1920(c); 1925(a); ............
1920(d); 1925(b); ............
1922(a) ...........................
1922(b) ...........................
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1924(b) ...........................
1924(c) ...........................
VerDate Sep<11>2014
Average number of
annual responses
Additional annual burden
hours (rounded)
27,054
15 operators ...........
405,810.
11,625
40 operators ..........
465,000.
1,525
75 operators ..........
114,375.
130 operators ×
365 days × 50
JSA’s per day =
2,372,500 *.
593,125.
Hour burden
ASP audit for Moderate Activity Operator ..............................
1920(b) ...........................
requirements in the normal course of
their activities. We consider these to be
usual and customary and took that into
account in estimating the burden.
15 mins.
15
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1,950.
15 operators × $217,000 audit = $3,255,000/3 =
$1,085,000.
40 operators × $108,000 audit = $4,320,000/3 =
$1,440,000.
75 operators × $62,000 audit = $4,650,000/3 =
$1,550,000.
NOTE: An audit is done once every 3 years.
Notify BSEE with audit plan/schedule 30 days prior to conducting your audit.
Submit to BSEE after completed audit, an audit report of
findings and conclusions, including deficiencies and required supporting information/documentation.
Submit/resubmit a copy of your CAP that will address deficiencies identified in audit within 60 days of audit completion.
Organization requests approval for AB; submits documentation for assessing, approving, maintaining, and withdrawing accreditation of ASP.
Make available to BSEE upon request, conflict of interest
procedures.
Make available to BSEE upon request, evaluation documentation and supporting information relating to your
SEMS.
Explain and demonstrate your SEMS during site visit if required; provide evidence supporting your SEMS implementation.
130 operators ........
1
44 (rounded).
4
130 operators/once
every 3 years =
44.
44 operators ...........
10
170 submissions ....
1,700.
15
3 requests ..............
45.
20 mins.
12 requests ............
4.
5
130 operators ........
650.
12
12 explanations .....
144.
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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
Citation 30 CFR 250 subpart S
Reporting and recordkeeping requirement +
Average number of
annual responses
1925(a); ..........................
Pay for all costs associated with BSEE directed ASP audit
approximately 10 percent per operator per category: 1 required audit for high operator ($217,000 per audit × 1
audit = $217,000); 4 required audits for moderate operator ($108,000 per audit × 4 audits = $432,000; and 8 required audits for low operator ($62,000 per audit per 8
audits = $496,000) = 13 required audits per year.
1928 ................................
1930(c) ...........................
(1) Document and keep all SEMS audits for 6 years (at
least two full audit cycles) at an onshore location.
(2) JSAs must have documented results in writing and kept
onsite for 30 days or until release of the MODU; retain
records for 2 years. (3) All MOC records (API RP Sec 4)
must be documented, dated, and retained for 2 years. (4)
SWA documentation must be kept onsite for 30 days; retain records for 2 years. (5) Documentation of employee
participation must be retained for 2 years.
(6) All documentation included in this requirement must be
made available to BSEE upon request.
Document decision to resume SWA activities .......................
1933(a) ...........................
Personnel reports unsafe practices and/or health violations
1933(c) ...........................
Post notice where personnel can view their rights for reporting unsafe practices.
15 mins.
Total Subpart S .......
.................................................................................................
........................
.................................................................................................
........................
Hour burden
39155
Additional annual burden
hours (rounded)
13 BSEE directed ASP audits—for a total of
$1,145,000.
6
62 hrs/mo ×
12 mos/yr =
744 hrs
2
8
130 operators ........
838 manned facilities.
1,620 unmanned facilities.
130 operators once
every 2 wks =
130 × 52/2 =
3,380.
Burden covered under 30 CFR 250,
Subpart A 1014–0022
2,435 facilities ........
2,381,721 Responses.
780.
623.472.
3,240.
27,040.
0.
609 (rounded).
2,238,164
Hours.
$5,220,000 Non-Hour Cost Burdens
srobinson on DSK5SPTVN1PROD with NOTICES
* We calculated operators conducting 50 JSAs a day (25 JSAs for each 12 hour shift). Some contractors may perform none for a particular
day, whereas others may conduct more than 50 per day. This estimate is an average. Also, in Alaska, the Alaska Safety Handbook or ASH is
followed on the North Slope, which is a book containing both safety standards and the permit to work process for North Slope operations. The
ASH includes work permits which include a hazards analysis and mitigation measures section on the back of the permit.
+ In the future, BSEE may require electronic filing of some submissions.
Estimated Reporting and
Recordkeeping Non-Hour Cost Burden
We have identified four non-hour cost
burdens:
§ 250.1925(a)—Pay for all costs
associated with a BSEE directed audit
due to deficiencies.
§ 250.1920(a)—ASP audits for High,
Moderate, and Low Activity Operator.
We estimate a total reporting nonhour cost burden to industry of
$5,220,000 for this collection of
information. We have not identified any
other non-hour cost burdens associated
with this collection of information.
Public Disclosure Statement: The PRA
(44 U.S.C. 3501, et seq.) provides that an
agency may not conduct or sponsor a
collection of information unless it
displays a currently valid OMB control
number. Until OMB approves a
collection of information, you are not
obligated to respond.
Comments: Before submitting an ICR
to OMB, PRA section 3506(c)(2)(A)
requires each agency ‘‘. . . to provide
notice . . . and otherwise consult with
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18:49 Jul 07, 2015
Jkt 235001
members of the public and affected
agencies concerning each proposed
collection of information . . .’’.
Agencies must specifically solicit
comments to: (a) Evaluate whether the
collection is necessary or useful; (b)
evaluate the accuracy of the burden of
the proposed collection of information;
(c) enhance the quality, usefulness, and
clarity of the information to be
collected; and (d) minimize the burden
on the respondents, including the use of
technology.
Agencies must also estimate the nonhour paperwork cost burdens to
respondents or recordkeepers resulting
from the collection of information.
Therefore, if you have other than hour
burden costs to generate, maintain, and
disclose this information, you should
comment and provide your total capital
and startup cost components or annual
operation, maintenance, and purchase
of service components. For further
information on this burden, refer to 5
CFR 1320.3(b)(1) and (2), or contact the
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Bureau representative listed previously
in this notice.
We will summarize written responses
to this notice and address them in our
submission for OMB approval. As a
result of your comments, we will make
any necessary adjustments to the burden
in our submission to OMB.
Public Comment Procedures: Before
including your address, phone number,
email address, or other personal
identifying information in your
comment, you should be aware that
your entire comment—including your
personal identifying information—may
be made publicly available at any time.
While you can ask us in your comment
to withhold your personal identifying
information from public review, we
cannot guarantee that we will be able to
do so.
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Federal Register / Vol. 80, No. 130 / Wednesday, July 8, 2015 / Notices
Dated: July 1, 2015.
Robert W. Middleton,
Deputy Chief, Office of Offshore Regulatory
Programs.
[FR Doc. 2015–16675 Filed 7–7–15; 8:45 am]
BILLING CODE 4310–VH–P
DEPARTMENT OF JUSTICE
Drug Enforcement Administration
[Docket No. DEA–418P]
Proposed Adjustments to the
Aggregate Production Quotas for
Schedule I and II Controlled
Substances and Assessment of
Annual Needs for the List I Chemicals
Ephedrine, Pseudoephedrine, and
Phenylpropanolamine for 2015
Drug Enforcement
Administration, Department of Justice.
ACTION: Notice with request for
comments.
AGENCY:
The Drug Enforcement
Administration proposes to adjust the
2015 aggregate production quotas for
several controlled substances in
schedules I and II of the Controlled
Substances Act and the assessment of
annual needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine.
SUMMARY:
Interested persons may file
written comments on this notice in
accordance with 21 CFR 1303.13(c) and
1315.13(d). Electronic comments must
be submitted, and written comments
must be postmarked, on or before
August 7, 2015. Commenters should be
aware that the electronic Federal Docket
Management System will not accept
comments after 11:59 p.m. Eastern Time
on the last day of the comment period.
ADDRESSES: To ensure proper handling
of comments, please reference ‘‘Docket
No. DEA–418P’’ on all correspondence,
including any attachments. The Drug
Enforcement Administration encourages
that all comments be submitted
electronically through the Federal
eRulemaking Portal which provides the
ability to type short comments directly
into the comment field on the Web page
or attach a file for lengthier comments.
Please go to http://www.regulations.gov
and follow the online instructions at
that site for submitting comments. Upon
completion of your submission you will
receive a Comment Tracking Number for
your comment. Please be aware that
submitted comments are not
instantaneously available for public
view on Regulations.gov. If you have
received a Comment Tracking Number,
your comment has been successfully
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DATES:
VerDate Sep<11>2014
18:49 Jul 07, 2015
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submitted and there is no need to
resubmit the same comment. Paper
comments that duplicate electronic
submissions are not necessary and are
discouraged. Should you wish to mail a
paper comment in lieu of an electronic
comment, it should be sent via regular
or express mail to: Drug Enforcement
Administration, Attention: DEA Federal
Register Representative/ODL, 8701
Morrissette Drive, Springfield, Virginia
22152.
John
R. Scherbenske, Office of Diversion
Control, Drug Enforcement
Administration, 8701 Morrissette Drive,
Springfield, Virginia 22152, Telephone:
(202) 598–6812.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Posting of Public Comments
Please note that all comments
received in response to this docket are
considered part of the public record and
will be made available for public
inspection online at http://
www.regulations.gov. Such information
includes personal identifying
information (such as your name,
address, etc.) voluntarily submitted by
the commenter.
The Freedom of Information Act
(FOIA) applies to all comments
received. If you want to submit personal
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
phrase ‘‘PERSONAL IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all the personal identifying information
you do not want made publicly
available in the first paragraph of your
comment and identify what information
you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be made
publicly available, you must include the
phrase ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify the confidential
business information to be redacted
within the comment. If a comment has
so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be made available in the public
docket. Comments containing personal
identifying information or confidential
business information identified as
directed above will be made publicly
available in redacted form.
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An electronic copy of this document
is available at http://
www.regulations.gov for easy reference.
Legal Authority and Background
Section 306 of the Controlled
Substances Act (CSA), 21 U.S.C. 826,
requires the Attorney General to
determine the total quantity and
establish aggregate production quotas
for each basic class of controlled
substance listed in schedules I and II
and for the list I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine. This
responsibility has been delegated to the
Administrator of the DEA. 28 CFR
0.100(b).
The DEA established the 2015
aggregate production quotas for
substances in schedules I and II and the
assessment of annual needs for the list
I chemicals ephedrine,
pseudoephedrine, and
phenylpropanolamine on September 8,
2014 (79 FR 53216). That notice
stipulated that, in accordance with 21
CFR 1303.13 and 1315.13, all aggregate
production quotas and assessments of
annual need are subject to adjustment.
Analysis for Proposed Adjusted 2015
Aggregate Production Quotas and
Assessment of Annual Needs
The DEA proposes to adjust the
established 2015 aggregate production
quotas for certain schedule I and II
controlled substances to be
manufactured in the United States in
2015 to provide for the estimated
medical, scientific, research, and
industrial needs of the United States,
lawful export requirements, and the
establishment and maintenance of
reserve stocks. These quotas do not
include imports of controlled
substances for use in industrial
processes. The DEA is not proposing to
adjust the established 2015 assessment
of annual needs for the list I chemicals
ephedrine, pseudoephedrine, and
phenylpropanolamine to be
manufactured in and imported into the
United States in 2015 to provide for the
estimated medical, scientific, research,
and industrial needs of the United
States, lawful export requirements, and
the establishment and maintenance of
reserve stocks.
In proposing the adjustment, the DEA
has taken into account the criteria that
the DEA is required to consider in
accordance with 21 CFR 1303.13 and 21
CFR 1315.13. The DEA determines
whether to propose an adjustment of the
aggregate production quotas for basic
classes of schedule I and II controlled
substances and assessment of annual
needs for ephedrine, pseudoephedrine,
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File Modified | 2015-07-08 |
File Created | 2015-07-08 |