- Small rural HMIWI
                                      0.5
                                      52
                                      26
                                       2
                                      52
                                      2.6
                                      5.2
                                                                     $5,742.49
- All other HMIWI
                                      1.5
                                      52
                                      78
                                      45
                                     3,510
                                     175.5
                                      351
                                                                   $387,618.08
          Records of CMS operation and maintenance

- Small rural HMIWI
                                      0.5
                                      250
                                      125
                                       2
                                      250
                                     12.5
                                      25
                                                                    $27,608.13
- All other HMIWI
                                      1.5
                                      250
                                      375
                                      45
                                    16,875
                                    843.75
                                     1,688
                                                                 $1,863,548.44
         Records of emissions/parameter exceedances and periods when emission/parameter data not obtained [j]

- Small rural HMIWI
                                      0.5
                                      52
                                      26
                                      0.4
                                     10.4
                                     0.52
                                     1.04
                                                                     $1,148.50
- All other HMIWI
                                      1.5
                                      52
                                      78
                                       9
                                      702
                                     35.1
                                     70.2
                                                                    $77,523.62
         Records of annual and subsequent compliance tests
                                    See 4E

         Records of annual equipment inspection
                                    See 4B

     F.  Time to train personnel
                                      40
                                       1
                                      40
                                       0
                                       0
                                       0
                                       0
                                                                            $0
     G. Time for audits
                                      N/A

Subtotal for Recordkeeping Requirements (Privately-owned HMIWI)

                                    29,042
                                                                  $2,788,796.10
10.  Recordkeeping requirements (Federally-owned HMIWI)

     A.  Read instructions
                                      N/A

     B.  Plan activities
                                      N/A

     C.  Implement activities
                                      N/A

     D.  Develop record system
                                      N/A

     E.  Time to enter information

          Records of startup, shutdown, malfunction
                                      1.5
                                      52
                                      78
                                       6
                                      468
                                     23.4
                                     46.8
                                                                    $51,682.41
          Records of persons reviewing operating information
                                       2
                                       2
                                       4
                                       6
                                      24
                                      1.2
                                      2.4
                                                                     $2,650.38
          Records of operators completing training  requirements
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                             $0
          Records of operators that have been qualified
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                             $0
          Records of initial performance test
                                    See 5E

          Records of process and control device operating parameters
                                      1.5
                                      52
                                      78
                                       6
                                      468
                                     23.4
                                     46.8
                                                                    $51,682.41
          Records of CMS operation and maintenance
                                      1.5
                                      250
                                      375
                                       6
                                     2,250
                                     112.5
                                      225
                                                                   $248,473.13
         Records of emissions/parameter exceedances and periods when emission/parameter data not obtained [j]
                                      1.5
                                      52
                                      78
                                      1.2
                                     93.6
                                     4.68
                                     9.36
                                                                    $10,336.48
         Records of annual and subsequent compliance tests
                                    See 5E

         Records of annual equipment inspection
                                    See 5B

     F.  Time to train personnel
                                      40
                                       1
                                      40
                                       0
                                       0
                                       0
                                       0
                                                                             $0
     G. Time for audits
                                      N/A

Subtotal  for Recordkeeping Requirements  (Federally-owned HMIWI)

                                     3,799
                                                                    $364,824.81
11.  Recordkeeping requirements (State/locally-owned HMIWI)

     A.  Read instructions
                                      N/A

     B.  Plan activities
                                      N/A

     C.  Implement activities
                                      N/A

     D.  Develop record system
                                      N/A

     E.  Time to enter information

          Records of startup, shutdown, malfunction
                                      1.5
                                      52
                                      78
                                       4
                                      312
                                     15.6
                                     31.2
                                                                    $34,454.94
          Records of persons reviewing operating information r
                                       2
                                       2
                                       4
                                       4
                                      16
                                      0.8
                                      1.6
                                                                     $1,766.92
          Records of operators completing training  requirements
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                            $0
          Records of operators that have been qualified
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                            $0
          Records of initial performance test
                                    See 5E

          Records of process and control device operating parameters
                                      1.5
                                      52
                                      78
                                       4
                                      312
                                     15.6
                                     31.2
                                                                    $34,454.94
          Records of CMS operation and maintenance
                                      1.5
                                      250
                                      375
                                       4
                                     1,500
                                      75
                                      150
                                                                   $165,648.75
         Records of emissions/parameter exceedances and periods when emission/parameter data not obtained [j]
                                      1.5
                                      52
                                      78
                                      0.8
                                     62.4
                                     3.12
                                     6.24
                                                                     $6,890.99
         Records of annual and subsequent compliance tests
                                    See 5E

         Records of annual equipment inspection
                                    See 5B

     F.  Time to train personnel
                                      40
                                       1
                                      40
                                       0
                                       0
                                       0
                                       0
                                                                            $0
     G. Time for audits
                                      N/A

Subtotal  for Recordkeeping Requirements  (State/Locally-owned HMIWI)

                                     2,533
                                                                    $243,216.54
12.  Recordkeeping requirements (co-fired and pathological/low-level radioactive/ chemotherapeutic combustors)

     A.  Read instructions
                                      N/A

     B.  Plan activities
                                      N/A

     C.  Implement activities
                                      N/A

     D.  Develop record system
                                      N/A

     E.  Time to enter information

         Quarterly records of periods when only pathological, low-level radioactive, chemotherapeutic waste burned [k]
                                       2
                                       4
                                       8
                                     13.4
                                     107.2
                                     5.36
                                     10.72
                                                                    $11,838.36
         Quarterly records of weight of hospital waste and medical/infectious waste combusted, and weight of all other fuels and waste combusted (co-fired only) [k]
                                       2
                                       4
                                       8
                                       5
                                      40
                                       2
                                       4
                                                                     $4,417.30
Subtotal  for Recordkeeping Requirements  (Co-fired and pathological/low level radioactive / chemotherapeutic combustors)

                                      169

                                                                     $16,255.66
     F.  Time to train personnel
                                      N/A

     G.  Time for audits
                                      N/A

TOTAL REPORTING REQUIREMENTS (FROM SUBTOTALS)

                                    24,537
                                                                     $2,333,255
TOTAL RECORDKEEPING REQUIREMENTS (FROM SUBTOTALS)

                                    35,543
                                                                     $3,413,093
TOTAL LABOR BURDEN AND COST (ROUNDED)

                                    60,080
                                                                     $5,746,349

Note: States and tribes may choose to impose requirements that are more stringent.  However, the burden estimates provided in this ICR assume that the state and tribal plans mirror the federal Emission Guidelines.

Assumptions:
[a]  We have assumed that there are approximately 79 respondents, with no additional new or reconstructed sources becoming subject to the rule over the next three years.
The breakdown is as follows: 47 privately-owned HMIWI (including 2 small rural HMIWI), 6 Federally-owned HMIWI, and 4 State/locally-owned HMIWI, and  22 States that require annual State Plan Inventory.
 [b]  This ICR uses the following labor rates for industry:  $120.77  per hour for Executive, Administrative, and Managerial labor; $99.39 per hour for Technical labor, and $50.04 per hour for Clerical labor.  These rates are from the United States Department of Labor, Bureau of Labor Statistics, December 2011 "Table 2. Civilian Workers, by Occupational and Industry group."  The rates are from column 1, "Total Compensation."  The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.  In addition, this ICR uses the following labor rates for State government: $66.98 for Managerial labor; $52.13 for Technical labor, and $24.35 for Clerical labor. These rates are from the United States Department of Labor, Bureau of Labor Statistics, May 2011 National Industry-Specifics Occupational Employment and Wage Estimates for State government (NAICS code 999200). The rates have been increased by 60 percent to account for the benefit packages available to State government employees.
[c]  Assume all 22 states with HMIWI have approved State Plan by the first year of this ICR. However, the State Plan/Inventory is updated on an annual basis.
[d] We have assumed that it will take 40 hours for each new respondent to read requirements.
[e]  The zero value for number of respondents indicates that burden was incurred prior to the time period covered by this supporting statement or for new respondents.
[f]  We have assumed that it would take each respondent 20 hours each to update the annual operating information.
[g]  We have assumed that it would take each respondent 8 hours to review the operating information with each operator.
[h]  We have assumed that each facility will take 160 hours to develop the operating information.
[i]  We have assumed that each facility will rake 40 hours to develop the waste management plan.
[j]  Assume 20 percent of respondents report exceedances, and 80 percent report no exceedances.
k  We have assumed that all co-fired and pathological/low-level radioactive/ chemotherapeutic combustors units would be owned by the private sector.

Table 2: Average Annual EPA Burden and Cost  -  State and Federal Emission Guidelines for Hospital/Medical/Infectious Waste Incinerators (40 CFR Part 60, Subpart Ce and 40 CFR Part 62, Subpart HHH) (Renewal)

                                  Burden item
                        (A) Person hours per occurrence
                (B) No. of occurrences per respondent per year
               (C) Person hours per respondent per year (C=AxB)
                         (D) Respondents per year  [a]
                 (E) Technical person- hours per year (E=CxD)
                 (F) Management person hours per year (Ex0.05)
                  (G) Clerical person hours per year (Ex0.1)
                          (H) Total Cost per year [b]
1.  Initial performance test
                                      32
                                       1
                                      32
                                       0
                                       0
                                       0
                                       0
                                                                            $0
2.  Repeat performance test

     A.  Retesting preparation
                                      12
                                       1
                                      12
                                       0
                                       0
                                       0
                                       0
                                                                            $0
     B.  Attend retesting
                                      32
                                       1
                                      32
                                       0
                                       0
                                       0
                                       0
                                                                            $0
3.  Report review

     A. Review reports for co-fired combustors

         Review notification of exemption claim
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                            $0
         Review notification of relative amounts of hospital waste, medical/infectious waste, and other fuels and wastes to be combusted
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                            $0
     B. Review notification of exemption claim for pathological, low-level radioactive, chemotherapeutic combustors
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                            $0
     C. Review reports of increments of progress

         Review control plan
                                       4
                                       1
                                       4
                                       0
                                       0
                                       0
                                       0
                                                                            $0
         Review notification of construction contracts
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                            $0
         Review notification of construction  commencement
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                            $0
         Review notification of construction completion
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                            $0
         Review notification of control plan completion
                                       2
                                       1
                                       2
                                       0
                                       0
                                       0
                                       0
                                                                            $0
     D. Review request for extension for HMIWI planning to shut down late
                                       4
                                       1
                                       4
                                       0
                                       0
                                       0
                                       0
                                                                            $0
     E. Review reports for small non-rural, medium and large HMIWI

        Review waste management plan
                                       8
                                       1
                                       8
                                       0
                                       0
                                       0
                                       0
                                                                            $0
        Review notification of initial performance test
                                       8
                                       1
                                       8
                                       0
                                       0
                                       0
                                       0
                                                                            $0
        Review notification of initial CMS demonstration
                                       5
                                       1
                                       5
                                       0
                                       0
                                       0
                                       0
                                                                            $0
        Review report of initial performance test
                                      36
                                       1
                                      36
                                       0
                                       0
                                       0
                                       0
                                                                            $0
        Review report of initial CMS demonstration
                                      24
                                       1
                                      24
                                       0
                                       0
                                       0
                                       0
                                                                            $0
        Review annual report

            CMS operating parameters

- Small rural HMIWI
                                       2
                                       1
                                       2
                                       2
                                       4
                                      0.2
                                      0.4
                                                                       $207.30
- All other HMIWI
                                       6
                                       1
                                       6
                                      55
                                      330
                                     16.5
                                      33
                                                                    $17,102.09
 Emissions/parameter exceedances and periods when emission/parameter data not obtained [c]

- Small rural HMIWI
                                       4
                                       1
                                       4
                                      0.4
                                      1.6
                                     0.08
                                     0.16
                                                                        $82.92
- All other HMIWI
                                      16
                                       1
                                      16
                                      11
                                      176
                                      8.8
                                     17.6
                                                                     $9,121.11
            Results of annual performance test

- Small rural HMIWI
                                       6
                                       1
                                       6
                                       2
                                      12
                                      0.6
                                      1.2
                                                                       $621.89
- All other HMIWI
                                      24
                                       1
                                      24
                                      55
                                     1,320
                                      66
                                      132
                                                                    $68,408.34
            Report of no exceedances

- Small rural HMIWI
                                       2
                                       1
                                       2
                                      1.6
                                      3.2
                                     0.16
                                     0.32
                                                                       $165.84
- All other HMIWI
                                       8
                                       1
                                       8
                                      44
                                      352
                                     17.6
                                     35.2
                                                                    $18,242.22
        Review semiannual report of emissions/ parameter exceedances and periods when emission/parameter data not obtained [c]

- Small rural HMIWI
                                       2
                                       1
                                       2
                                      0.4
                                      0.8
                                     0.04
                                     0.08
                                                                        $41.46
- All other HMIWI
                                       8
                                       1
                                       8
                                      11
                                      88
                                      4.4
                                      8.8
                                                                     $4,560.56
         Report of annual equipment inspection (Small rural HMIWI)
                                       4
                                       1
                                       4
                                       2
                                       8
                                      0.4
                                      0.8
                                                                       $414.60
         Report of annual control equipment inspection (All other HMIWI)
                                       4
                                       1
                                       4
                                       0
                                       0
                                       0
                                       0
                                                                            $0
     G. Review reports for States

        Review annual update of State Plan Inventory [d]
                                       8
                                       1
                                       8
                                      22
                                      176
                                      8.8
                                     17.6
                                                                     $9,121.11
4.  Prepare annual summary report [e]
                                       1
                                       1
                                       1
                                      57
                                      57
                                      2.9
                                      5.7
                                                                     $2,954.00
                         TOTAL ANNUAL BURDEN AND COST
                                     2,908
                                                                   $131,043.43

--------------------------------------------------------------------------------
Assumptions:
    a  We have assumed that there are approximately 57 respondents, with no additional new or reconstructed sources becoming subject to the rule over the next three years.  The 57 respondents are located in 22 States.
[b]  This cost is based on the following hourly labor rates times a 1.6 benefits multiplication factor to account for government overhead expenses: $62.27 for Managerial (GS-13, Step 5, $38.92 x 1.6), $46.21 for Technical (GS-12, Step 1, $28.88 x 1.6) and $25.01 Clerical (GS-6, Step 3, $15.63 x 1.6).  These rates are from the Office of Personnel Management (OPM) "2011 General Schedule" which excludes locality rates of pay.
[c]  Assume 20 percent of respondents report parameter exceedances, and 80 percent report no exceedances.
[d]  Assume all 22 States have approved State/Plan Inventory by the first year of this ICR. All States are expected to update State Plan/Inventory annually.
[e]  We have assumed that all respondents will have to prepare annual summary report.


[Federal Register: February 16, 2007 (Volume 72, Number 32)]
[Notices]
[Page 7647-7648]
[DOCID:fr16fe07-77]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-067-000]

Dominion Transmission, Inc.; Notice of Intent To Prepare an
Environmental Assessment for the Proposed Ellisburg Replacement Well
Project and Request for Comments on Environmental Issues

February 9, 2007.
    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the Ellisburg Replacement Well
Project involving the installation and operation of two new injection/
withdrawal wells by Dominion Transmission, Inc. (DTI) within its
Ellisburg Storage Field located in Potter County, Pennsylvania.\1\ This
EA will be used by the Commission in its decision-making process to
determine whether the project is in the public convenience and
necessity.
---------------------------------------------------------------------------

    \1\ DTI's application was filed with the Commission under
section 7 of the Natural Gas Act and Part 157 of the Commission's
regulations.
---------------------------------------------------------------------------

    This notice announces the opening of the public comment period that
will be used to gather environmental input from the public and
interested agencies on the project. Comments are requested by March 9,
2007.
    If you are a landowner receiving this notice, you may be contacted
by a company representative about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the project is approved by the Commission, that approval conveys with
it the right of eminent domain. Therefore, if easement negotiations
fail to produce an agreement, the company could initiate condemnation
proceedings in accordance with state law.
    A brochure prepared by the FERC entitled ``An Interstate Natural
Gas Facility On My Land? What Do I Need To Know?'' is available for
viewing on the FERC Web site at http://www.ferc.gov. This fact sheet

addresses a number of typically asked questions, including the use of
eminent domain and how to participate in the Commission's proceedings.

Summary of the Proposed Project

    DTI seeks authority to install and operate two new wells, EW-210
and EW-326, located in its Ellisburg Storage Field. The new wells would
replace two previously abandoned wells, EW-203 and EW-313. The previous
well abandonments were completed under DTI's blanket certificate
authorization in Docket No. CP06-419-000.
    The new well EW-210 would be installed approximately 32 feet
northwest of EW-203, and the new EW-326 well would be located
approximately 49 feet northeast of EW-313. In addition, DTI would
connect the new wells to the existing storage pipeline network by
installing approximately 230 feet of new well pipeline. The
construction and operation of the new pipeline would be performed under
DTI's existing blanket certificate authorization in Docket No. CP82-
537-000. The new wells are required to maintain the overall
deliverability of the Ellisburg Storage Field.
    The general locations of the new wells are shown in Appendix 1.\2\
---------------------------------------------------------------------------

    \2\ The appendices referenced in this notice are not being
printed in the Federal Register. Copies of all appendices, other
than Appendix 2 (map), are available on the Commission's website at
the ``eLibrary'' link or from the Commission's Public Reference
Room, 888 First Street, NE., Washington, DC 20426, or call (202)
502-8371. For instructions on connecting to eLibrary refer to the
last page of this notice. Copies of the appendices were sent to all
those receiving this notice in the mail.
---------------------------------------------------------------------------

Land Requirements

    Construction of the new wells would require about 3.31 acres of
land and includes access roads, staging areas and extra work areas.
Each well site would require approximately 1.62 acres. Following
construction, about 1.26 acres would be permanently maintained. The
remaining 2.05 acres of land would be restored and allowed to revert to
its former use.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
to discover and address concerns the public may have about proposals.
This process is referred to as ``scoping''. The main goal of the
scoping process is to focus the analysis in the EA on the

important environmental issues. By this Notice of Intent, the
Commission staff requests public comments on the scope of the issues to
address in the EA. All comments received are considered during the
preparation of the EA. State and local government representatives are
encouraged to notify their constituents of this proposed action and
encourage them to comment on their areas of concern.
    Our \3\ independent analysis of the issues will be in the EA.
Depending on the comments received during the scoping process, the EA
may be published and mailed to federal, state and local agencies,
public interest groups, interested individuals, affected landowners,
newspapers, libraries and the Commission's official service list for
this proceeding. A comment period will be allotted for review if the EA
is published. We will consider all comments on the EA before we make
our recommendations to the Commission.
---------------------------------------------------------------------------

    \3\ ``We'', ``us'', and ``our'' refer to the environmental staff
of the Office of Energy Projects (OEP).
---------------------------------------------------------------------------

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. By becoming a commentor, your
concerns will be addressed in the EA and considered by the Commission.
You should focus on the potential environmental effects of the
proposal, alternatives to the proposal (including alternative
locations), and measures to avoid or lessen environmental impact. The
more specific your comments, the more useful they will be. Please
carefully follow the instructions below to ensure that your comments
are received in time and properly recorded:
     Send an original and two copies of your letter to: Magalie
R. Salas, Secretary, Federal Energy Regulatory Commission, 888 First
St., NE., Room 1A, Washington, DC 20426.
     Label one copy of the comments for the attention of Gas
Branch 3.
     Reference Docket No. CP07-067-000.
     Mail your comments so that they will be received in
Washington, DC on or before March 9, 2007.
    The Commission strongly encourages electronic filing of comments.
Please refer to 18 Code of Federal Regulations (CFR)
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
at http://www.ferc.gov under the ``e-Filing'' link and the link to the

User's Guide. Prepare your submission in the same manner as you would
if filing on paper and save it to a file on your hard drive. Before you
can file comments, you will need to create an account by clicking on
``Login to File'' and then ``New User Account.'' You will be asked to
select the type of filing you are making. This filing is considered a
``Comment on Filing.''
    The determination of whether to distribute the EA for public
comment will be based on the response to this notice. If you are
interested in receiving a copy of the EA, please return the Information
Request form (Appendix 2). An effort is being made to send this notice
to all individuals affected by the proposed project. This includes all
landowners who are potential right-of-way grantors, whose property may
be used temporarily for project purposes, or who own homes within
distances defined in the Commission's regulations of certain
aboveground facilities.

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an official party to the proceeding, or ``intervenor''. To
become an intervenor, you must file a motion to intervene according to
Rule 214 of the Commission's Rules of Practice and Procedure (18 CFR
385.214). Intervenors have the right to seek rehearing of the
Commission's decision. Motions to Intervene should be electronically
submitted using the Commission's eFiling system at http://www.ferc.gov.

Persons without Internet access should send an original and 14 copies
of their motion to the Secretary of the Commission at the address
indicated previously. Persons filing Motions to Intervene on or before
the comment deadline indicated above must send a copy of the motion to
the Applicant. All filings, including late interventions, submitted
after the comment deadline must be served on the Applicant and all
other intervenors identified on the Commission's service list for this
proceeding. Persons on the service list with email addresses may be
served electronically; others must be served a hard copy of the filing.
    Affected landowners and parties with environmental concerns may be
granted intervenor status upon showing good cause by stating that they
have a clear and direct interest in this proceeding which would not be
adequately represented by any other parties. You do not need intervenor
status to have your environmental comments considered.

Environmental Mailing List

    If you wish to remain on our environmental mailing list, please
return the Information Request form included in Appendix 3. If you do
not return this form, you will be removed from our mailing list.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at 1-866-208-FERC or on the
FERC Internet Web site (http://www.ferc.gov) using the eLibrary link.

Click on the eLibrary link, click on ``General Search'' and enter the
docket number excluding the last three digits in the Docket Number
field. Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at 1-866-208-3676, or for TTY,

contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries and direct links to
the documents. Go to http://www.ferc.gov/esubscribenow.htm.

    Finally, public meetings or site visits will be posted on the
Commission's calendar located at http://www.ferc.gov/EventCalendar/EventsList.aspx
 along with other related information.

Magalie R. Salas,
Secretary.
 [FR Doc. E7-2698 Filed 2-15-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 80, Number 105 (Tuesday, June 2, 2015)]
[Notices]
[Pages 31384-31385]
[FR Doc No: 2015-13331]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0279]

Agency Information Collection Activities; Announcement of Office
of Management and Budget Approval; Prescription Drug Marketing Act of
1987; Policies, Requirements, and Administrative Procedures

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing

that a collection of information entitled ``Prescription Drug Marketing
Act of 1987; Policies, Requirements, and Administrative Procedures''
has been approved by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On March 06, 2015, the Agency submitted a
proposed collection of information entitled ``Prescription Drug
Marketing Act of 1987; Policies, Requirements, and Administrative
Procedures'' to OMB for review and clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information unless it displays a currently
valid OMB control number. OMB has now approved the information
collection and has assigned OMB control number 0910-0435. The approval
expires on May 31, 2018. A copy of the supporting statement for this
information collection is available on the Internet at http://www.reginfo.gov/public/do/PRAMain.

    Dated: May 28, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-13331 Filed 6-1-15; 8:45 am]
 BILLING CODE 4164-01-P


Section 108(b) discusses particular instruments for EPA to consider
in its regulations. Specifically, paragraph (b)(2) states that
financial responsibility may be established by any one, or any
combination, of the following: Insurance, guarantee, surety bond,
letter of credit, or qualification as a self-insurer. Paragraph (b)(2)
further authorizes the President to specify policy or other contractual
terms, conditions, or defenses that are necessary, or that are
unacceptable in establishing evidence of financial responsibility.
Paragraph (b)(2) also requires EPA to cooperate with and seek the
advice of the commercial insurance industry to the maximum extent
practicable when developing financial responsibility requirements.
Paragraph (b)(4) provides direction on how the section 108(b)
instruments are to address multiple owners and operators at a single
facility.
    Section 108(c) also includes a ``direct action'' provision, under
which CERCLA claims can be brought directly against an insurer or other
entity issuing an instrument pursuant to the section 108(b)
regulations. Section 108(c)(2) provides that any claim authorized by
section 107 or section 111 may be asserted directly against any
guarantor providing evidence of financial responsibility under section
108(b) if the person is liable under section 107 and: (1) Is in
bankruptcy, reorganization, or arrangement pursuant to the Federal
Bankruptcy Code, or (2) is likely to be solvent at the time of judgment
but over whom jurisdiction in the federal courts cannot be reached with
reasonable diligence.
    The areas of most significant concern identified by commenters are:
(1) The specification that the instruments need pay to multiple
claimants; (2) the direct action provisions in the instruments; and (3)
the continuity of coverage provisions that subject providers to
potential liability. These three features of the proposed section
108(b) financial responsibility program and the comments received
regarding each are discussed below.
The Specification That the Instruments Need Pay to Multiple Claimants
    EPA proposed that instruments would be payable to the full range of
potential future CERCLA claimants, and not solely to a currently
designated beneficiary specified in instruments.
    Financial industry representatives commenting on the proposed rule
expressed concerns that the proposed financial mechanisms would not
have a single designated beneficiary. Commenters argued that instrument
providers would be required to undertake more due diligence and
exercise more discretion while also potentially being subject to more
liability themselves absent a specified designated beneficiary.
Direct Action Provision
    Commenters also expressed concern that providers of instruments may
be subject to direct action suit. However, the CERCLA statute itself,
at section 108(c)(2), includes a direct action provision that expressly
authorizes, in specified circumstances, any claim under section 107 and
section 111 be made directly against the guarantor providing evidence
of financial responsibility. Commenters from the surety industry
claimed that the direct action provision significantly increased their
risk exposure and included too broad of a trigger (bankruptcy). Banking
industry representatives asserted that the provision was at odds with
relevant commercial law and practice and would significantly deter
banks from providing such instruments and services. The insurance
industry commented that direct action creates the potential for
significant increase in defense costs and administrative costs
associated with the management of multiple lawsuits.
Continuity of Coverage Provisions
    To address the risk that the facility would no longer have
financial responsibility when necessary, EPA proposed that owners and
operators using a letter of credit, surety bond or insurance to
demonstrate financial responsibility also establish a standby trust. In
the event the instrument issuer intended to cancel the instrument and
the owner or operator failed to obtain alternate financial
responsibility, EPA could draw on the instrument and fund the standby
trust.
    Commenters from the surety and insurance industry suggested that
the requirements for prescriptive cancellation provisions that include
potential issuer liability would limit the interest on behalf of
sureties and insurers in providing mechanisms.

Commenters also suggested that this proposed provision in combination
with the difficult-to-predict date at which a facility may be released
from the proposed financial responsibility requirements created
unwelcome uncertainty around the duration of the provider's obligation.
    Based on the negative comments received, EPA believes there is
uncertainty around the adequate availability of instruments were final
regulations to be promulgated at this time. This uncertainty
necessarily means it is also unclear whether regulated entities would
be able to obtain the necessary instruments when faced with a
regulatory obligation under section 108(b) to obtain an instrument.
This information thus also indicates that issuance of section 108(b)
requirements for current hardrock mining operations is not appropriate.

E. Challenges To Identify the Facility

    Many commenters on the rule raised concerns regarding the
applicability of section 108(b) to historical mining areas at
facilities. The question of what the relevant facility is for purposes
of section 108(b) regulations arose in several contexts--developing
requirements for applicability of the rule, determining a financial
responsibility amount, and developing conditions for payment of funds
from the instruments. This was another difficult challenge EPA
encountered in developing the proposed rule.
    In a typical CERCLA response action, the definition of the facility
relies on a site-by-site determination based on site-specific
conditions, and the facility is defined by where contamination comes to
be located, as understood by EPA at a particular point in time, and is
typically formally delineated in a decision document identifying the
response actions to be taken. The relevant facility may include areas
owned and/or operated by several parties and the facility is defined
without regard to ownership. In addition, particular parties' CERCLA
liability is determined through settlements and/or litigation.
    For the reasons discussed in the proposed rule, for purposes of
determining the proposed rule's applicability, and for determining the
financial responsibility amount, EPA found it necessary to consider the
relevant facility to be only the current operations of the current
owner(s) and operator(s). Two effects of this approach were to not
require a financial responsibility amount under the proposed rule based
on conditions present at historic areas of the mine, or to require
evidence of financial responsibility from parties other than the
current owner(s) or operator(s).
    This approach--that EPA found necessary to implement section
108(b)--has no effect on CERCLA liability for parties that may be
involved at a CERCLA site, or on the definition of facility for
purposes of a CERCLA response. Thus, in the context of a particular
response action, the facility may be defined to include an area broader
than the current operations, and CERCLA liability may attach to parties
other than the current owner or operator. Thus, there is an
inconsistency in these respects between what EPA believed was necessary
for practical development of section 108(b) instruments, and the
definition that would apply when the instruments are invoked.
    This difficulty was also identified by outside parties to EPA.
Instrument providers, during pre-proposal outreach, cited the inability
to distinguish between and establish separate amounts for historic
releases and potential future releases as a factor that may increase
the cost and difficulty of obtaining instruments. Specifically,
representatives of insurance companies noted that combining two
distinct types of coverage (e.g., coverage for cleanup of known
existing releases and coverage for liabilities that may arise from
future releases) will increase premiums. Another insurance
representative commented that amounts of coverage may be limited by
reinsurance treaties if the two types of coverage were combined.\334\
Relatedly, a representative from a surety also noted that separating
out known pre-existing issues and releases from current operations that
have not yet occurred into separate mechanisms would likely enhance
availability.\335\ Yet it was the impossibility of predetermining the
source of any contamination that would ultimately be the subject of a
CERCLA claim, or where contamination would ultimately come to be
located, that was a factor in EPA's decision to propose instruments
that could pay for any CERCLA section 107 or section 111 claims against
a current owner or operator, irrespective of whether the claim arose as
a result of current or historical operations.
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    \334\ See Notes and Attendees for CERCLA 108(b) Insurance
Meeting December 8, 2015 Docket ID: EPA-HQ-SFUND-2015-0781-0447.
    \335\ See Notes and Attendees for CERCLA 108(b) Surety Meeting
January 14, 2016 Docket ID: EPA-HQ-SFUND-2015-0781-0445.
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    Commenters' concerns also highlight another source of uncertainty
for instrument availability. Thus, this issue raises similar concerns
as in section E. Above. Therefore, this information further supports
EPA's determination that issuance of section 108(b) requirements for
current hardrock mining operations is not appropriate.

VII. Statutory and Executive Order Reviews \336\
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    \336\ Additional information about these statutes and Executive
Orders can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.
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A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is a significant regulatory action that was submitted
to the Office of Management and Budget (OMB) for review, because it may
raise novel legal or policy issues [3(f)(4)], although it is not
economically significant. Any changes made in response to OMB
recommendations have been documented in the docket. EPA prepared an
economic analysis for the proposed rule, but that analysis is not
relevant for this final rulemaking because no regulatory provisions are
being finalized.

B. Executive Order 13771: Reducing Regulation and Controlling
Regulatory Costs

    This action is not an Executive Order 13771 regulatory or
deregulatory action, because this action does not alter any regulatory
requirements.

C. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA, because this action does not impose any regulatory
requirements.

D. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. This
action will not impose any requirements on small entities.

E. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandate as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments, because this action does not impose any regulatory
requirements.

F. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not have
substantial direct effects on the states, on the relationship between
the national

government and the states, or on the distribution of power and
responsibilities among the various levels of government.

G. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175, because this action imposes no regulatory
requirements. Thus, Executive Order 13175 does not apply to this
action. However, EPA consulted with tribes and Alaska Native
Corporations and Alaska Native Villages during the rulemaking process.
    EPA received comments from three federally-recognized tribes and
from three Alaska Native Claims Settlement Act (ANCSA) resource
managers regarding section 108(b) financial responsibility. Tribal
comments were generally in support of the proposed rule, and cited some
concerns about the potential negative impacts of hardrock mining on
commercial enterprises and on subsistence living, along with the need
to more fully identify the benefits of the rule. A primary ANCSA
concern was that the section 108(b) financial responsibility
requirements would duplicate existing federal and state requirements,
resulting in a negative impact on Alaska Natives and states, that
receive royalties through the Regional and Village Corporations. Other
ANCSA comments related primarily to the calculation of the financial
responsibility amount, and requested that EPA consult with them early
in the regulatory development process. EPA acknowledged the challenges
in determining a financial responsibility amount, and provided the
opportunity for federally-recognized tribes and ANCSA resource managers
to consult with the Agency during the public comment period.

H. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    This action is not subject to Executive Order 13045 because it is
not economically significant as defined in Executive Order 12866, and
because EPA does not believe the environmental health or safety risks
addressed by this action present a disproportionate risk to children,
since this action imposes no regulatory requirements.

I. Executive Order 13211: Actions That Significantly Affect Energy
Supply, Distribution, or Use

    This action is not a ``significant energy action'' because it is
not likely to have a significant adverse effect on the supply,
distribution or use of energy.

J. National Technology Transfer and Advancement Act

    This rulemaking does not involve technical standards.

K. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    EPA believes that this action is not subject to Executive Order
12898 (59 FR 7629, February 16, 1994) because it does not establish an
environmental health or safety standard, since this action imposes no
regulatory requirements.

L. Congressional Review Act (CRA)

    This action is subject to the CRA, and EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 320

    Environmental protection, Financial responsibility, Hardrock
mining, Hazardous substances.

    Dated: December 1, 2017.
E. Scott Pruitt,
Administrator.
[FR Doc. 2017-26514 Filed 2-20-18; 8:45 am]
BILLING CODE 6560-50-P