                                 ATTACHMENT J
                     Detailed Burden and Cost Calculations

Wage Rates

Respondents
                                 ICR Category
                                 BLS Category
                                Overall Hourly
                                     Wage
                                Fringe Benefit
                              Total Compensation
                     Overhead % of Total Compensation [c]
                                   Overhead
                              Hourly Loaded Wages
                                    Rounded
General civilian
All workers (average civilian worker) [a]
                                    $38.26
                                    $26.25
                                    $12.01
                                    $38.26
                                      20%
                                     $7.65
                                    $45.91
                                     $46
Management
Management, business and financial [b]
                                    $74.94
                                    $52.01
                                    $22.93
                                    $74.94
                                      20%
                                    $14.99
                                    $89.93
                                     $90
Technical
Professional and related [b]
                                    $69.80
                                    $46.57
                                    $23.23
                                    $69.80
                                      20%
                                    $13.96
                                    $83.76
                                     $84
Clerical
Office and administrative support [b]
                                    $29.87
                                    $20.39
                                     $9.48
                                    $29.87
                                      20%
                                     $5.97
                                    $35.84
                                     $36
[a] Source: Bureau of Labor Statistics, 2020 (https://www.bls.gov/news.release/pdf/ecec.pdf)
[b] Source: Bureau of Labor Statistics, 2020 (https://www.bls.gov/web/ecec/ecsuphst.pdf)
[c] An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (EPA 2020).
Note: the loaded wage is only used when considering burden for technical materials, thereby excluding the POY Awards and redesign consultations.

Agency
                                 ICR Category
                                 OPM Category
                                Overall Hourly
                              Loading Factor [a]
                                 Loaded Wages
                                    Rounded
Management
GS-13 Step 5
                                    $56.31
                                     1.639
                                    $92.29
                                      $92
Technical
GS-10 Step 10
                                    $41.25
                                     1.639
                                    $67.61
                                      $68
Clerical
GS-5 Step 1
                                    $19.01
                                     1.639
                                    $31.16
                                      $31
Source: Office of Personnel Management, 2021 (https://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/21Tables/html/DCB_h.aspx)
[a] Source: Falk, J. 2012. "Comparing Benefits and Total Compensation in the Federal Government and the Private Sector." Congressional Budget Office Working Paper Series. (https://www.cbo.gov/sites/default/files/112th-congress-2011-2012/workingpaper/2012-04fedbenefitswp0.pdf)

IC #1: Safer Choice product recognition program applications

Respondents
Collection Activity
                        Hours and Costs Per Respondent
                             Total Hours and Costs

                                     Mgr.

                                     Tech.

                                     Cler.

                               Response Hours/Yr
                                Labor Cost/Year
                                    Capital
                                     Cost
                                O & M Cost*
                              Number of Respon.**
                                Total Hours/Yr
                                 Total Cost/Yr
Partnership Agreements
Review program information
                                                                              1
                                                                              1
                                                                              0
                                                                              2
                                                                        $174.00
                                                                            $0
                                                                            $0
                                                                             44
                                                                             88
                                                                        $7,656
Fill out and submit third-party information request form
                                                                              0
                                                                              5
                                                                              1
                                                                              6
                                                                        $456.00
                                                                            $0
                                                                            $0
                                                                             44
                                                                            264
                                                                       $20,064
Establish agreement with third-party profiler
                                                                              1
                                                                              1
                                                                              1
                                                                              3
                                                                        $210.00
                                                                            $0
                                                                       $12,400
                                                                             44
                                                                            132
                                                                      $554,840
Submit summary report to Safer Choice
                                                                              1
                                                                              1
                                                                              0
                                                                              2
                                                                        $174.00
                                                                            $0
                                                                            $0
                                                                             44
                                                                             88
                                                                        $7,656
Negotiate / establish Partnership Agreement w/ Safer Choice
                                                                              1
                                                                              2
                                                                              0
                                                                              3
                                                                        $258.00
                                                                            $0
                                                                            $0
                                                                             44
                                                                            132
                                                                       $11,352
Subtotal
                                                                              4
                                                                             10
                                                                              2
                                                                             16
                                                                      $1,272.00
                                                                            $0
                                                                       $12,400
                                                                             44
                                                                            704
                                                                      $601,568
Renewals and Audits
Renew partnership, with no changes needed
                                                                              0
                                                                              3
                                                                              1
                                                                              4
                                                                        $288.00
                                                                            $0
                                                                            $0
                                                                             36
                                                                            144
                                                                       $10,368
Desk audit
                                                                              0
                                                                              2
                                                                              2
                                                                              4
                                                                        $240.00
                                                                            $0
                                                                            $0
                                                                             24
                                                                             96
                                                                        $5,760
Site audit
                                                                              0
                                                                              2
                                                                              1
                                                                              3
                                                                        $204.00
                                                                            $0
                                                                            $0
                                                                             12
                                                                             36
                                                                        $2,448
Subtotal
                                                                              0
                                                                              7
                                                                              4
                                                                             11
                                                                          $732
                                                                            $0
                                                                            $0
                                                                             36
                                                                            276
                                                                       $18,576
Adding Private Label Partners and Products
Review program information
                                                                              1
                                                                              1
                                                                              0
                                                                              2
                                                                        $174.00
                                                                            $0
                                                                            $0
                                                                             77
                                                                            154
                                                                       $13,398
Fill out and submit online Private Label submission
                                                                              0
                                                                            4.5
                                                                            1.5
                                                                              6
                                                                        $432.00
                                                                            $0
                                                                            $0
                                                                             77
                                                                            462
                                                                       $33,264
Subtotal
                                                                              1
                                                                            5.5
                                                                            1.5
                                                                              8
                                                                          $606
                                                                            $0
                                                                            $0
                                                                             77
                                                                            616
                                                                       $46,662
TOTAL

                                                                            157
                                                                          1,596
                                                                      $666,806
* The cost for third-party profiler review and verification assumes that the typical application submitted by a cleaning product manufacturer will contain four products, each with 2 ingredients ($650 each), 1 proprietary ingredient ($1,300), and a $500 administrative fee. The total cost per product is $3,100. The total will be $12,400 per company per application.
**This column reports the number of annual respondents after accounting for the partnership renewal process.  Assumes that one in ten formulators over the three-year period will need to make changes to their formulations and go through a new partnership process which includes same collection steps.  On an annual basis, this translates to 4 product formulators (for a total of 44 partnership agreements).  Also assumes that about 33% of the remaining product formulators will be subject to site audits each year (i.e., 12) and that about 66% (i.e., 24) will be subject to desk audits each year. Assumes that 77 partners will fill out Private Label submissions based on historical data.

Agency
Collection Activity
                        Hours and Costs Per Respondent
                             Total Hours and Costs

                                 Mgr. Hours/Yr
                                Tech. Hours/Yr
                                Agency Hours/Yr
                                Labor Cost/Year
                            Capital / Startup Cost
                                O & M Cost
                              Number of Respon.*
                                Total Hours/Yr
                                 Total Cost/Yr

Cleaning and Non-Cleaning Products
Review program application forms
                                                                              0
                                                                              1
                                                                              1
                                                                           $68
                                                                            $0
                                                                            $0
                                                                             44
                                                                             44
                                                                        $2,992
Review third-party profiler summary
                                                                              0
                                                                              5
                                                                              5
                                                                          $340
                                                                            $0
                                                                            $0
                                                                             44
                                                                            220
                                                                       $14,960
Negotiate / establish Partnership Agreement with formulator
                                                                              1
                                                                              2
                                                                              3
                                                                          $228
                                                                            $0
                                                                            $0
                                                                             44
                                                                            132
                                                                       $10,032
Review partnership renewal, with no changes needed
                                                                              1
                                                                              1
                                                                              2
                                                                          $160
                                                                            $0
                                                                            $0
                                                                             36
                                                                             72
                                                                        $5,760
Review audit summaries
                                                                              0
                                                                              1
                                                                              1
                                                                           $68
                                                                            $0
                                                                            $0
                                                                             36
                                                                             36
                                                                        $2,448
Subtotal
                                                                              2
                                                                             10
                                                                             12
                                                                          $864
                                                                            $0
                                                                            $0
                                                                             80
                                                                            504
                                                                       $36,192
Adding Private Label Partners and Products
Review Private Label submissions
                                                                              0
                                                                              2
                                                                              2
                                                                          $136
                                                                            $0
                                                                            $0
                                                                             77
                                                                            154
                                                                       $10,472
Subtotal
                                                                              0
                                                                              2
                                                                              2
                                                                          $136
                                                                            $0
                                                                            $0
                                                                             77
                                                                            154
                                                                        $10,472
TOTAL

                                                                            157
                                                                            658
                                                                       $46,664
*This column reports the number of respondents after accounting for the partnership renewal process.  Assumes that one in ten formulators will need to make changes to their formulations and go through a new partnership process which includes same collection steps, i.e. 4, for a total of 44 annually. Assumes that 77 partners will fill out Private Label submissions based on historical data.

IC #2: Safer Choice label consultations

Respondents
Collection Activity
                             Number of Respondents
                             Frequency of Response
                              Hours Per Response
                              Total Burden Hours
                                  Total Cost
Screening for Consumer Focus Groups
                                      300
                                       1
                                     0.17
                                      51
                                                                        $2,346
Consumer Focus Group Interviews
                                      30
                                       1
                                       2
                                      60
                                                                        $2,760
Consumer Online Survey
                                     2,000
                                       1
                                     0.33
                                      660
                                                                       $30,360
TOTAL
                                     2,330
                                      --
                                      --
                                      771
                                                                       $35,466
Note: No capital or operating and maintenance costs are incurred by respondents under this component of the ICR.

Agency
                              Collection Activity
                               EPA Burden Hours
                                   EPA Costs

                                  Mgr. Hours

                                  Tech. Hours
                                Total EPA Hours
                               Contractor Cost*
                                   EPA Cost
Consumer Focus Groups
Prepare focus group materials
                                                                            0.5
                                                                              2
                                                                            2.5
                         $35,750 for ten focus groups
                                                                          $182
Prepare screener questionnaires
                                                                            0.5
                                                                              2
                                                                            2.5

                                                                          $182
Organize and conduct focus groups
                                                                              0
                                                                              0
                                                                              0

                                                                            $0
Review focus group results
                                                                              5
                                                                             20
                                                                             25

                                                                        $1,820
Subtotal
                                                                              6
                                                                             24
                                                                             30
                                                                       $35,750
                                                                        $2,184
Consumer Online Surveys
Prepare consumer online surveys
                                                                              1
                                                                              4
                                                                              5
                   $23,625 for four consumer online surveys
                                                                          $364
Review consumer online survey results
                                                                              2
                                                                              8
                                                                             10

                                                                          $728
Subtotal
                                                                              3
                                                                             12
                                                                             15
                                                                       $23,625
                                                                        $1,092
TOTAL
                                                                              9
                                                                             36
                                                                             45
                                                                       $59,375
                                                                        $3,276
Note: Due to the contractor costs, these figures represent the total agency burden across the three-year period of the ICR.
Note: No capital or operating and maintenance costs are incurred by the Agency under this component of the ICR.
* Contractor cost for consumer focus groups includes facility rental, recruiting, honorariums, transcription, and reimbursement to focus group participants for their travel and time (assumed $100 per participant). Contractor cost for consumer online surveys includes questionnaire development, programming, online fielding and results reporting.

IC #3: Safer Choice Partner of the Year Awards program

Respondents
                              Collection Activity
                           Estimated # of Applicants
                        Estimated Response Time (Hours)
                             Total Burden (Hours)
                                  Total Cost

                                     Mgr.
                                     Tech.
                                     Cler.
                                     Mgr.
                                     Tech.
                                     Cler.
                                     Total

Formulators/Product Manufacturers
Review application and program information

                                       0
                                       1
                                       0
                                       0
                                      19
                                       0
                                      19
                                    $1,326
Obtain senior approval

                                       1
                                       1
                                       1
                                      19
                                      19
                                      19
                                      57
                                    $3,318
Complete and submit package

                                       0
                                      10
                                       1
                                       0
                                      190
                                      19
                                      209
                                   $13,830
Subtotal
                                      19
                                       1
                                      12
                                       2
                                      19
                                      228
                                      38
                                      285
                                  $18,473.32
Innovators
Review application and program information

                                       0
                                       1
                                       0
                                       0
                                       5
                                       0
                                       5
                                     $349
Obtain senior approval

                                       1
                                       1
                                       1
                                       5
                                       5
                                       5
                                      15
                                     $873
Complete and submit package[1]

                                       0
                                      10
                                       1
                                       0
                                      50
                                       5
                                      55
                                    $3,639
Subtotal
                                       5
                                       1
                                      12
                                       2
                                       5
                                      60
                                      10
                                      75
                                   $4,861.40
Retailers
Review application and program information

                                       0
                                       1
                                       0
                                       0
                                       3
                                       0
                                       3
                                     $209
Obtain senior approval

                                       1
                                       1
                                       1
                                       3
                                       3
                                       3
                                       9
                                     $524
Complete and submit package

                                       0
                                      10
                                       1
                                       0
                                      30
                                       3
                                      33
                                    $2,184
Subtotal
                                       3
                                       1
                                      12
                                       2
                                       3
                                      36
                                       6
                                      45
                                   $2,916.84
Supporters
Review application and program information

                                       0
                                       1
                                       0
                                       0
                                       6
                                       0
                                       6
                                     $419
Obtain senior approval

                                       1
                                       1
                                       1
                                       6
                                       6
                                       6
                                      18
                                    $1,048
Complete and submit package

                                       0
                                      10
                                       1
                                       0
                                      60
                                       6
                                      66
                                    $4,367
Subtotal
                                       6
                                       1
                                      12
                                       2
                                       6
                                      72
                                      12
                                      90
                                   $5,833.68
Purchasers and Distributors
Review application and program information

                                       0
                                       1
                                       0
                                       0
                                       2
                                       0
                                       2
                                     $140
Obtain senior approval

                                       1
                                       1
                                       1
                                       2
                                       2
                                       2
                                       6
                                     $349
Complete and submit package

                                       0
                                      10
                                       1
                                       0
                                      20
                                       2
                                      22
                                    $1,456
Subtotal
                                       2
                                       1
                                      12
                                       2
                                       2
                                      24
                                       4
                                      30
                                   $1,944.56
TOTAL
                                      35

                                      525
                                    $34,030
Note: All respondents are from the private sector, other than potential respondents in the "Purchasers and Distributors" and "Supporters" categories which may include local and state governments.

Agency
                                  Activities
                           Hours per Labor Category
                            Total Cost per Activity
                             Total Hours and Cost

                                  Mgr. Hours
                                  Tech. Hours
                                  Mgr. Hours
                                  Tech. Hours
                           Total Hours per Activity
                            Total Cost per Activity
Distribute forms
                                       2
                                       8
                                     $184
                                     $544
                                      10
                                     $728
Answer questions
                                       2
                                       8
                                     $184
                                     $544
                                      10
                                     $728
Record / enter forms
                                       3
                                      10
                                     $276
                                     $680
                                      13
                                     $956
Verify information; Make awards selection
                                       4
                                      13
                                     $368
                                     $884
                                      17
                                    $1,252
Notify applicants of decision
                                       1
                                       3
                                      $92
                                     $204
                                       4
                                     $296
TOTAL
                                      12
                                      42
                                    $1,104
                                    $2,856
                                      54
                                    $3,960


[Federal Register Volume 83, Number 230 (Thursday, November 29, 2018)]
[Notices]
[Pages 61391-61393]
[FR Doc No: 2018-25959]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5570]

Select Updates for Recommendations for Clinical Laboratory
Improvement Amendments of 1988 Waiver Applications for Manufacturers of
In Vitro Diagnostic Devices; Draft Guidance for Industry and Food and
Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of the draft guidance entitled ``Select Updates for
Recommendations for Clinical Laboratory Improvement Amendments of 1988
Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.''
FDA has developed this draft guidance to implement the 21st Century
Cures Act (the Cures Act), which requires FDA to revise ``Section V.
Demonstrating Insignificant Risk of an Erroneous Result--Accuracy'' of
the guidance ``Recommendations for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In
Vitro Diagnostic Devices'' (``2008 CLIA Waiver Guidance'') that was
issued on January 30, 2008. This draft guidance represents FDA's
current thinking regarding ``the appropriate use of comparable
performance between a waived user and a moderately complex laboratory
user to demonstrate accuracy.'' The 2008 CLIA Waiver Guidance remains
in effect, in its current form, until this draft guidance is finalized,
at which time the updates in section III of this draft guidance will
supersede the recommendations in section V of the 2008 CLIA Waiver
Guidance. This draft guidance is not final nor is it in effect at this
time.

DATES: Submit either electronic or written comments on the draft
guidance by February 27, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2017-D-5570 for ``Select Updates for Recommendations for Clinical
Laboratory Improvement Amendments of 1988 Waiver Applications for
Manufacturers of In Vitro Diagnostic Devices.'' Received comments will
be placed in the docket and, except for those submitted as
``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the draft guidance document entitled
``Select Updates for Recommendations for Clinical Laboratory
Improvement Amendments of 1988 Waiver Applications for Manufacturers of
In Vitro Diagnostic Devices'' to the Office of the Center Director,
Guidance and Policy Development, Center for Devices and Radiological
Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
66, Rm. 5431, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach, and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your request.

FOR FURTHER INFORMATION CONTACT: Peter Tobin, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire

Ave., Bldg. 66, Rm. 5657, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
and Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has developed this draft guidance to implement section 3057 of
the Cures Act (Pub. L. 114-255), which requires FDA to revise ``Section
V. Demonstrating Insignificant Risk of an Erroneous Result--Accuracy''
of the guidance ``Recommendations for Clinical Laboratory Improvement
Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In
Vitro Diagnostic Devices'' \1\ (``2008 CLIA Waiver Guidance'') that was
issued on January 30, 2008. This draft guidance represents FDA's
current thinking regarding ``the appropriate use of comparable
performance between a waived user and a moderately complex laboratory
user to demonstrate accuracy.'' The 2008 CLIA Waiver Guidance remains
in effect, in its current form, until this draft guidance is finalized,
at which time the updates in section III of this draft guidance will
supersede the recommendations in section V of the 2008 CLIA Waiver
Guidance.
---------------------------------------------------------------------------

    \1\ https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm070890.pdf.
---------------------------------------------------------------------------

    FDA will incorporate the final version of this draft guidance into
``Section V. Demonstrating Insignificant Risk of an Erroneous Result--
Accuracy'' of the 2008 CLIA Waiver Guidance. The remainder of the 2008
CLIA Waiver Guidance, with exception of technical edits for consistency
with the newly amended section V, will not be substantively changed and
will remain in effect.
    The Secretary of Health and Human Services has delegated to FDA (69
FR 22849, April 27, 2004) the authority to determine whether particular
tests are ``simple'' and have ``an insignificant risk of an erroneous
result'' under CLIA and thus are eligible for CLIA waiver (42 U.S.C.
263a(d)(3)). The Centers for Medicare & Medicaid Services is
responsible for oversight of clinical laboratories, which includes
issuing Certificates of Waiver. CLIA requires that clinical
laboratories obtain a certificate before accepting materials derived
from the human body for laboratory tests (42 U.S.C. 263a(b)).
    The 2008 CLIA Waiver Guidance describes recommendations for device
manufacturers about study design and analysis for CLIA Waiver by
Application to support an FDA determination as to whether the device
meets the statutory criteria for waiver (42 U.S.C. 263a(d)(3)).
    On November 29, 2017, FDA announced in the Federal Register a draft
guidance entitled ``Select Updates for Recommendations for Clinical
Laboratory Improvement Amendments of 1988 Waiver Applications for
Manufacturers of In Vitro Diagnostic Devices'' (82 FR 56607). This
draft guidance proposed additional approaches for demonstrating that a
test meets the criteria in 42 U.S.C. 263a(d)(3)(A). FDA is issuing a
revised draft guidance by the same title, after considering comments
received on the draft guidance issued November 29, 2017.

II. Significance of Guidance

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Select
Updates for Recommendations for Clinical Laboratory Improvement
Amendments of 1988 Waiver Applications for Manufacturers of In Vitro
Diagnostic Devices.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

III. Electronic Access

    Persons interested in obtaining a copy of the draft guidance may do
so by downloading an electronic copy from the internet. A search
capability for all Center for Devices and Radiological Health guidance
documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This
guidance document is also available at https://www.regulations.gov or
https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to
download an electronic copy of ``Select Updates for Recommendations for
Clinical Laboratory Improvement Amendments of 1988 Waiver Applications
for Manufacturers of In Vitro Diagnostic Devices'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number 16046 to identify the
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
the following FDA regulations and guidance have been approved by OMB as
listed in the following table:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA
             form                       Topic           OMB Control No.
------------------------------------------------------------------------
50, 56........................  Protection of Human            0910-0755
                                 Subjects: Informed
                                 Consent;
                                 Institutional Review
                                 Boards.
54............................  Financial Disclosure           0910-0396
                                 by Clinical
                                 Investigators.
812...........................  Investigational                0910-0078
                                 Device Exemption.
``Recommendations for Clinical  CLIA Waiver                    0910-0598
 Laboratory Improvement          Applications.
 Amendments of 1988 (CLIA)
 Waiver Applications for
 Manufacturers of In Vitro
 Diagnostic Devices''.
``Administrative Procedures     CLIA Categorizations.          0910-0607
 for Clinical Laboratory
 Improvement Amendments of
 1988 Categorization''.
``Requests for Feedback on      Q-submissions........          0910-0756
 Medical Device Submissions:
 The Pre-Submission Program
 and Meetings with Food and
 Drug Administration Staff''.
------------------------------------------------------------------------

    Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-25959 Filed 11-28-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 78 (Monday, April 24, 2023)]
[Notices]
[Page 24790]
[FR Doc No: 2023-08514]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 1927-140]

PacifiCorp; Notice of Availability of Environmental Assessment

    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission or FERC)
regulations, 18 CFR part 380, Commission staff reviewed PacifiCorp's
application for an amendment to the license of the North Umpqua
Hydroelectric Project No. 1927 and have prepared an Environmental
Assessment (EA) for the proposed amendment. The licensee proposes to
amend the project license to include the construction, operation, and
maintenance of new pumped storage facilities connecting the existing
Toketee and Fish Creek developments. The North Umpqua project consists
of eight developments located on the North Umpqua River and two of its
tributaries, the Clearwater River and Fish Creek, in Douglas County,
Oregon and is partially located on lands administered by the U.S.
Department of Agriculture's Forest Service and the U.S. Department of
the Interior's Bureau of Land Management.
    The EA contains Commission staff's analysis of the potential
environmental effects of the proposed amendment to the license, and
concludes that the proposed amendment, with appropriate environmental
protective measures, would not constitute a major federal action that
would significantly affect the quality of the human environment.
    A copy of the EA may be viewed on the Commission's website at
http://www.ferc.gov using the ``elibrary'' link. Enter the docket
number (P-1927) in the docket number field to access the document. For
assistance, contact FERC Online Support at [email protected]
or toll-free at 1-866-208-3676, or for TTY,<PHONE_NUMBER>.
    For further information, contact Brian Bartos at<PHONE_NUMBER> or
[email protected].

    Dated: April 17, 2023.
Kimberly D. Bose,
Secretary.
[FR Doc. 2023-08514 Filed 4-21-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 31, 2007 (Volume 72, Number 169)]
[Notice]
[Page 50351-50352]
[DOCID:fr31au07-80]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-363-001]

Sabine Pipe Line, LLC; Notice of Negotiated Rate

August 22, 2007.
    Take notice that on August 9, 2007, Sabine Pipe Line Company, LLC
(Sabine) tendered for filing as part of its FERC Gas Tariff, Original
Volume No. 1, First Revised Sheet No. 314, to be effective August 1,
2007.
    Sabine states that the proposed change would update its tariff to
accurately state the current negotiated rate transaction information as
required by section 26.5 of Sabine's tariff.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
Section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or

before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://
www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-17249 Filed 8-30-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: March 11, 2008 (Volume 73, Number 48)]
[Notices]
[Page 12975-12976]
[DOCID:fr11mr08-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12960-000]

Kentucky Hydro 6, LLC; Notice of Application Accepted for Filing
and Soliciting Motions To Intervene, Protests, and Comments

March 4, 2008.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12960-000.
    c. Date filed: August 14, 2007.
    d. Applicant: Kentucky Hydro 6, LLC.
    e. Name of Project: Kentucky River Lock and Dam 6
Hydroelectric Project
    f. Location: Kentucky River in Woodford County, Kentucky. It would
use the U.S. Army Corps of Engineers' Kentucky River Lock and Dam
6.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Brent L. Smith, COO, Symbiotics, LLC,
P.O. Box 535, Rigby, ID 83442,<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. Comments, protests, and interventions may be
filed electronically via the Internet in lieu of paper; see 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings. Please include the project number (P-12960-000) on
any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project using the U.S. Army
Corps of Engineers' Kentucky River Lock and Dam 6 and operated
in a run-of-river mode would consist of: (1) A new powerhouse and
switchyard; (2) two turbine/generator units with a combined installed
capacity of 10 megawatts; (3) a new 3-mile-long above ground 25-
kilovolt transmission line extending from the switchyard to an
interconnection point with the local utility's distribution system; and
(4) appurtenant facilities. The proposed Kentucky River Lock and Dam
6 Project would have an average annual generation of 30
gigawatt-hours.
    l. This filing is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, call toll-free 1-866-208-3676 or
e-mail<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy
is also available for inspection and reproduction at the address in
item h above.
    m. Competing Preliminary Permit--Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    n. Competing Development Application--Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    o. Notice of Intent--A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    p. Proposed Scope of Studies Under Permit--A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    q. Comments, Protests, or Motions to Intervene--Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    r. Filing and Service of Responsive Documents--Any filings must
bear in all capital letters the title ``COMMENTS'', ``NOTICE OF INTENT
TO FILE COMPETING APPLICATION'', ``COMPETING APPLICATION'',
``PROTEST'', and ``MOTION TO INTERVENE'', as applicable, and the

Project Number of the particular application to which the filing
refers. Any of the above-named documents must be filed by providing the
original and the number of copies provided by the Commission's
regulations to: The Secretary, Federal Energy Regulatory Commission,
888 First Street, NE., Washington, DC 20426. An additional copy must be
sent to Director, Division of Hydropower Administration and Compliance,
Federal Energy Regulatory Commission, at the above-mentioned address. A
copy of any notice of intent, competing application or motion to
intervene must also be served upon each representative of the Applicant
specified in the particular application.
    s. Agency Comments--Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-4740 Filed 3-10-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: October 20, 2009 (Volume 74, Number 201)]
[Notices]
[Page 53790-53791]
[DOCID:fr20oc09-102]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Altiva Financial Corp., Atlantic Gulf Communities Corp., CFI
Mortgage, Inc., Commodore Holdings Ltd., Conversion Technologies
International, Inc., Cyntech Technologies, Inc., Diversified Senior
Services, Inc., Dyersburg Corp., Flour City International, Inc., Gerald
Stevens, Inc., Leisure Time Casinos & Resorts, Inc., and Platinum
Entertainment, Inc. (n/k/a Vidalia Gichner Holdings, Inc.),; Order of
Suspension of Trading

October 16, 2009.

    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Altiva Financial Corp. because it has not filed any periodic reports
since the period ended February 29, 2000.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Atlantic Gulf Communities Corp. because it has

not filed any periodic reports since the period ended September 30,
2000.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
CFI Mortgage, Inc. because it has not filed any periodic reports since
the period ended September 30, 2001.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Commodore Holdings Ltd. because it has not filed any periodic reports
since the period ended June 30, 2000.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Conversion Technologies International, Inc. because it has not filed
any periodic reports since the period ended June 30, 2000.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Cyntech Technologies, Inc. because it has not filed any periodic
reports since the period ended July 31, 2002.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Diversified Senior Services, Inc. because it has not filed any periodic
reports since the period ended September 30, 2001.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Dyersburg Corp. because it has not filed any periodic reports since the
period ended March 31, 2001.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Flour City International, Inc. because it has not filed any periodic
reports since the period ended July 31, 2001.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Gerald Stevens, Inc. because it has not filed any periodic reports
since the period ended November 30, 2000.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Leisure Time Casinos & Resorts, Inc. because it has not filed any
periodic reports since the period ended June 30, 2000.
    It appears to the Securities and Exchange Commission that there is
a lack of current and accurate information concerning the securities of
Platinum Entertainment, Inc. (n/k/a Vidalia Gichner Holdings, Inc.)
because it has not filed any periodic reports since the period ended
March 31, 2000.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above-listed companies. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the securities of the above-listed companies is suspended
for the period from 9:30 a.m. EDT on October 16, 2009, through 11:59
p.m. EDT on October 29, 2009.

    By the Commission.
Elizabeth M. Murphy,
Secretary.
[FR Doc. E9-25286 Filed 10-16-09; 11:15 am]

BILLING CODE 8011-01-P


[Federal Register: September 30, 2005 (Volume 70, Number 189)]
[Notices]
[Page 57338-57339]
[DOCID:fr30se05-158]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-52503; File No. SR-Amex-2005-066]

Self-Regulatory Organizations; American Stock Exchange LLC; Order
Approving a Proposed Rule Change and Amendment No. 1 Thereto Relating
to the Exchange's Determination of the National Best Bid or Offer When
Another Exchange Is Disconnected From the Intermarket Option Linkage

September 23, 2005.

I. Introduction

    On June 17, 2005, the American Stock Exchange LLC (``Amex''), filed
with the Securities and Exchange Commission (``Commission'') a proposed
rule change pursuant to Section 19(b)(1) of the Securities Exchange Act
of 1934 (``Act'') \1\ and Rule 19b-4 thereunder,\2\ to amend Amex Rules
933(g) and 933(g)-ANTE regarding the determination of the National Best
Bid or Offer (``NBBO'') when another participant in the Plan for the
Purpose of Creating and Operating an Intermarket Option Linkage
(``Linkage Plan'') \3\ is disconnected from the Linkage.\4\ On August
4, 2005, the Amex filed Amendment No. 1 to the proposed rule change.\5\
The proposed rule change, as amended, was published for comment in the
Federal Register on August 23, 2005.\6\ The Commission received one
comment letter on the proposal.\7\ This order approves the proposed
rule change, as amended.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ On July 28, 2000, the Commission approved a national market
system plan for the purpose of creating and operating an intermarket
option linkage proposed by the Amex, the Chicago Board Options
Exchange, Incorporated, and the International Securities Exchange,
Inc. See Securities Exchange Act Release No. 43086 (July 28, 2000),
65 FR 48023 (August 4, 2000). Subsequently, upon separate requests
by the Philadelphia Stock Exchange, Inc., the Pacific Exchange,
Inc., and the Boston Stock Exchange, Inc., the Commission issued
orders to permit these exchanges to participate in the Linkage Plan.
See Securities Exchange Act Release Nos. 43573 (November 16, 2000),
65 FR 70851 (November 28, 2000); 43574 (November 16, 2000), 65 FR
70850 (November 28, 2000); and 49198 (February 5, 2004), 69 FR 7029
(February 12, 2004).
    \4\ See Amex Rule 940(b)(9).
    \5\ Amendment No. 1 superseded and replaced the original filing
in its entirety.
    \6\ See Securities Exchange Act Release No. 52270 (August 16,
2005), 70 FR 49335.
    \7\ See letter from Matthew Hinerfeld, Managing Director and
Deputy General Counsel, Citadel Investment Group, L.L.C., on behalf
of Citadel Derivatives Group LLC, to Jonathan G. Katz, Secretary,
Commission, dated August 26, 2005.
---------------------------------------------------------------------------

II. Description of the Proposed Rule Change

    The Amex proposes to amend Amex Rules 933(g) and 933(g)-ANTE to add
a provision regarding the determination of the NBBO when another
Participant Exchange \8\ is disconnected from the Linkage. Amex Rules
933(g) and 933(g)-ANTE currently provide that a Floor Governor or
Exchange Official may determine that certain quotes from another
Participant Exchange are not reliable when such other Participant
Exchange either (i) declares its quotes non-firm and directly
communicates or disseminates a message through Options Price Reporting
Authority (OPRA), or (ii) communicates to the Amex that such
Participant Exchange is experiencing systems or other problems
affecting the reliability of its disseminated quotes.
---------------------------------------------------------------------------

    \8\ A ``Participant Exchange'' is a registered national
securities exchange that is a party to the Linkage Plan. See Amex
Rule 940(b)(14).
---------------------------------------------------------------------------

    The Amex proposes to add to Amex Rules 933(g) and 933(g)-ANTE that
when another Participant Exchange is disconnected from the Linkage and
is not accepting Linkage orders, a Floor Governor or Exchange Official
may determine the quotes from such Participant Exchange are unreliable
and may exclude such quotes from the Amex's determination of the NBBO.
The Amex believes that adding this third circumstance is necessary
because there are times when due to system malfunctions, a Participant
Exchange is disconnected from the Linkage but has not declared its
quotes to be ``non-firm'' and has not informed the other exchanges that
the disconnected Participant Exchange may have quote problems. As a
result, access to the disconnected Participant Exchange is limited, and
the Amex believes such Participant Exchange's quotes should be excluded
from the Amex's determination of the NBBO.

III. Comment Received

    As noted above, the Commission received one comment letter on the
proposal.\9\ The commenter was strongly supportive of the Amex's
proposed rule change, including the Amex's proposed method of
determining that a Participant Exchange's quote is unreliable.\10\
---------------------------------------------------------------------------

    \9\ See supra note 7.
    \10\ The comment letter also addressed File No. SR-BSE-2005-30,
a proposal to allow the Boston Options Exchange (``BOX'') to exclude
a Participant Exchange's quotes from BOX's determination of the NBBO
when, among other circumstances, such Participant Exchange is
disconnected from Linkage. The commenter supported the Boston Stock
Exchange, Inc.'s proposal, but suggested a modification to the
proposal, as discussed in an order issued separately. See Securities
Exchange Act Release No. 52501 (September 23, 2005). In addition,
the commenter urged the Commission to address issues related to non-
firm quotes that are outside the scope of these proposed rule
changes.
---------------------------------------------------------------------------

IV. Discussion

    After careful consideration, the Commission finds that the proposed
rule change is consistent with the requirements of Section 6 of the Act
\11\ and the rules and regulations thereunder applicable to a national
securities exchange.\12\ In particular, the Commission finds that the
proposed rule change is consistent with Section 6(b)(5) of the Act,\13\
which requires, among other things, that the rules of the Amex be
designed to promote just and equitable principles of trade, to remove
impediments to and perfect the mechanism of a free and open market and
a national market system, and, in general, to protect investors and the
public interest. The Commission believes that it is appropriate for the
Amex to remove a Participant Exchange's disseminated quote(s) from the
Amex's determination of the NBBO when such Participant Exchange is
disconnected from Linkage and is not

accepting Linkage orders because access to such Participant Exchange's
quote(s) is limited during such times. The Commission further believes
that the Amex's existing rules establish appropriate procedures to
notify promptly the affected Participant Exchange and Amex member firms
of such removal and establish an appropriate standard for determining
when to resume inclusion of the affected Participant Exchange's
quote(s) in the Amex's NBBO.\14\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78f.
    \12\ In approving this proposal, the Commission has considered
the proposed rule's impact on efficiency, competition, and capital
formation. 15 U.S.C. 78c(f).
    \13\ 15 U.S.C. 78f(b)(5).
    \14\ See Amex Rules 933(g) and 933(g)-ANTE.
---------------------------------------------------------------------------

IV. Conclusion

    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\15\ that the proposed rule change (SR-Amex-2005-066), as amended,
is approved.
---------------------------------------------------------------------------

    \15\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\16\
---------------------------------------------------------------------------

    \16\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Jonathan G. Katz,
Secretary.
 [FR Doc. E5-5326 Filed 9-29-05; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register Volume 78, Number 89 (Wednesday, May 8, 2013)]
[Notices]
[Pages 26774-26775]
[FR Doc No: 2013-10885]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2012-0658; FRL-9530-9]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; NSPS/NESHAP for Wool Fiberglass
Insulation Manufacturing Plants (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: In compliance with the Paperwork Reduction Act (44 U.S.C. 3501
et seq.), this document announces that an Information Collection
Request (ICR) has been forwarded to the Office of Management and Budget
(OMB) for review and approval. This is a request to renew an existing
approved collection. The ICR which is abstracted below describes the
nature of the collection and the estimated burden and cost.

DATES: Additional comments may be submitted on or before June 7, 2013.

ADDRESSES: Submit your comments, referencing docket ID number EPA-HQ-
OECA-2012-0658, to: (1) EPA online, using www.regulations.gov (our
preferred method), or by email to<EMAIL_ADDRESS>or by mail to:
EPA Docket Center (EPA/DC), Environmental Protection Agency,
Enforcement and Compliance Docket and Information

Center, mail code 28221T, 1200 Pennsylvania Avenue NW., Washington, DC
20460; and (2) OMB at: Office of Information and Regulatory Affairs,
Office of Management and Budget (OMB), Attention: Desk Officer for EPA,
725 17th Street NW., Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Avenue
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On October 17, 2012 (77 FR 63813), EPA sought comments on this
ICR pursuant to 5 CFR 1320.8(d). EPA received no comments. Any
additional comments on this ICR should be submitted to both EPA and OMB
within 30 days of this notice.
    EPA has established a public docket for this ICR under docket ID
number EPA-HQ-OECA-2012-0658, which is available for either public
viewing online at http://www.regulations.gov, or in person viewing at
the Enforcement and Compliance Docket in the EPA Docket Center (EPA/
DC), EPA West, Room 3334, 1301 Constitution Avenue NW., Washington, DC.
The EPA Docket Center Public Reading Room is open from 8:30 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Enforcement and Compliance Docket is (202)
566-1752.
    Use EPA's electronic docket and comment system at http://www.regulations.gov to either submit or view public comments, access
the index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or in paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidentiality of Business Information (CBI), or
other information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to
www.regulations.gov.
    Title: NSPS/NESHAP for Wool Fiberglass Insulation Manufacturing
Plants (Renewal).
    ICR Numbers: EPA ICR Number 1160.12, OMB Control Number 2060-0114.
    ICR Status: This ICR is scheduled to expire on June 30, 2013. Under
OMB regulations, the Agency may continue to conduct or sponsor the
collection of information while this submission is pending at OMB.
    Abstract: The affected entities are subject to the General
Provisions of the NSPS/NESHAP at 40 CFR part 60, subpart A and part 63,
subpart A, and any changes, or additions to the Provisions specified at
40 CFR part 60, subpart PPP and part 63, subpart NNN.
    Owners or operators of the affected facilities must submit an
initial notification report, performance tests, and periodic reports
and results. Owners or operators are also required to maintain records
of the occurrence and duration of any startup, shutdown, or malfunction
in the operation of an affected facility, or any period during which
the monitoring system is inoperative. Reports are required annually at
a minimum.
    Respondents/Affected Entities: Owners or operators of wool
fiberglass manufacturing facilities.
    Estimated Number of Respondents: 61
    Frequency of Response: Occasionally and semiannually
    Estimated Total Annual Hour Burden: 18,559
    Estimated Total Annual Cost: $2,285,560, which includes $1,797,060
in labor costs, no capital/startup costs, and $488,500 in operation and
maintenance (O&M) costs.
    Changes in the Estimates: There is no change in the labor hours in
this ICR compared to the pervious ICR. This is due to two
considerations: (1) The regulations have not changed over the past
three years; and (2) the growth rate for the industry is very low,
negative or non-existent, so there is no significant change in the
overall burden. However, there is an adjustment increase in the total
estimated labor costs. The change in cost estimates occurred because
the labor rates have increased since the last ICR. This ICR used the
most recent labor rates in calculating all burden costs.
    Additionally, the annual public reporting and recordkeeping burden
for this collection of information has increased from 103 hours per
response to 145 hours per response (41 hours per response for 40 CFR
part 60, subpart PPP, and 249 hours per response for 40 CFR part 63,
subpart NNN). This is due to a correction in the total number of annual
responses. The total number of annual responses decreased from 180 to
128. To calculate the number of responses, the previous ICR assumed
that all 29 sources subject to subpart NNN were required to submit
Startup, Shutdown, and Malfunction (SSM) reports semiannually. This
method was inconsistent with the burden calculations for Tables 1a and
1b, which assumed only 10% of all sources submit such reports. This ICR
corrected the number of sources for submitting SSM reports, which
results in a decrease in the number of responses for subpart NNN.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2013-10885 Filed 5-7-13; 8:45 am]
BILLING CODE 6560-50-P