ECONOMIC ANALYSIS For the Addition of 23 Chemical Abstract Service ( CAS) numbered Chemicals Requested to be added to EPA's Preliminary Assessment Information Reporting ( PAIR) Rule in the 53rd Report of the TSCA Interagency Testing Committee Economic Policy Analysis Branch Economics, Exposure, and Technology Division Office of Pollution Prevention and Toxics U. S. Environmental Protection Agency 1200 Pennsylvania Avenue, N. W. Washington, D. C. 20460 April 2, 2004 1 1.0 OVERVIEW On June 22, 1982, the Environmental Protection Agency ( EPA) issued the Preliminary Assessment Information Reporting ( PAIR) Rule ( 47 FR 26992) under Section 8( a) of the Toxic Substances Control Act ( TSCA). Under the PAIR rule, which is codified at 40 CFR part 712, manufacturers ( defined by the statute to include importers) of specified chemicals are required to submit certain production, importation, use, and exposure data for these chemicals to the Agency. The reported information is be used by EPA and others ( e. g., the TSCA Interagency Testing Committee ( ITC) which has Members and Liaison Members from 16 Federal agencies) to assess health and environmental risks that may be posed by exposure to the subject chemicals. 23 chemicals were requested to be added to the PAIR rule by the TSCA ITC in its 53rd Report to the EPA Administrator ( see 69 FR 2467, January 15, 2004). These chemicals and their specific Chemical Abstract Service ( CAS) Registry numbers, which were provided in the ITC Reports, are presented in Table 1.

A report was located on only one of the 23 chemicals in EPA's 2002 Chemical Update System ( CUS) utilizing the ITC supplied CAS numbers, yielding one company producing that one chemical at one site. Because the threshold for reporting to CUS under the Inventory Update Rule is 10,000 lbs., and the threshold for PAIR reporting is 500 kg ( 1,100 lbs.), and because there is no requirement that inorganic chemicals be reported to CUS ( the majority of the tungsten compounds are inorganic), EPA assumed that one manufacturer exists per chemical to account for the possibility that there may be manufacturers producing PAIR reportable amounts that weren't captured by CUS. But EPA has no way of ascertaining this, a fact which highlights the need for PAIR reporting on these chemicals.

EPA has already published a standardized reporting form for the PAIR rule ( EPA Form No. 7710 35). The submitted forms are required to contain the following information:

Section I  Certification This section requires the reporter to verify that all information provided to EPA is complete and accurate. In addition, this section allows the reporter to claim information reported to be TSCA Confidential Business Information ( CBI). CBI claims require certification.

Section II  Chemical Identification Chemical name, CAS number, etc.

Section III  Respondent Identification Site name, location, address, technical contact's name and telephone number.

Section IV  Preliminary Assessment Information 2 Part A  Plant Site Activities  Quantities imported and/ or manufactured, quantities in waste or released to the environment, description of on site activities, quantities in products. Part B  Chemical Substance Processing by Customers  Customers' uses and products, market names, customers process categories.

Table 1: Chemicals and CAS Registry Numbers Provided in the 53rd ITC Report CAS NUMBER CHEMICAL NAME 504 29 0 2 Pyridinamine 462 08 8 3 Pyridinamine 504 24 5 4 Pyridinamine 1314 35 8 Tungsten oxide ( WO3)

7440 33 7 Tungsten 7783 82 6 Tungsten fluoride ( WF6), ( OC 6 11)

7790 85 4 Cadmium tungsten oxide ( CdWO4)

7790 60 5 Tungstate ( W04 2), dipotassium, ( T 4)

7783 03 1 Tungstate ( W04 2), dihyrogen, ( T 4)

10213 10 2 Tungstate ( W04 2), disodium, dihydrate, ( T 4)

11105 11 6 Tungsten oxide ( WO3), hydrate 11120 01 7 Sodium tungsten oxide 11120 25 5 Tungstate ( W12( OH) 2 O40 10), decaamonium 12067 99 1 Tungsten hydroxide oxide phosphate 12028 48 7 Tungstate ( W12( OH) 2 O38 6), hexaamonium 12027 38 2 Tungstate ( 4),[. mu. 12[ orthosilicato( 4) . kappa. O:. kappa. O:. kappa. O:. kappa. O':. kappa. O':. kappa. O':. kappa. O". kappa. O ":. kappa. O":. kappa. O'": kappa. O'":. kappa. O'"]] tetracosa. mu. oxododecaoxododeca, tetrahydrogen 12036 22 5 Tungsten oxide ( WO2)

12141 67 2 Tungsten ( W12( OH) 2O38 6), hexasodium 12138 09 9 Tungsten sulfide ( WS2)

13283 01 7 Tungsten chloride ( WCl6), ( OC 6 11)

12472 45 2 Tungstate ( W04 2), disodium, ( T 4)

14040 11 0 Tungsten carbonyl ( W( CO) 6), ( OC 6 11)

23321 70 2 Tungsten oxide ( WO3), dihydrate Both industry and government incur costs in responding to ( industry) and in implementing ( government) this reporting rule. The total costs and burden for industry and government are as follows: 1 " Burden Hour and Cost Estimates for PAIR Section 8( a) Reporting ( 1994 Update)," internal U. S. EPA memorandum form Carol Rawie, EETD, to Karen Boswell, CTIB, May 16, 1994. Economic Impact and Small Business Definition Analysis for TSCA Section 8( a) Preliminary Assessment Information Rule, Office of Regulatory Analysis, OTS, U. S. EPA, February 1980. Economic Analysis of the Final Section 8( a) Preliminary Assessment Information Rule, R. A. Horner, RIB, OTS, U. S. EPA, November 12, 1981.

2 U. S. Environmental Protection Agency, 2002. Wage Rates for Economic Analyses of the Toxics Release Inventory Program. Cody Rice, Analytical Support Branch, Office of Environmental Information. June 10, 2002.

3 Table 11 ( p. 15), U. S. Department of Labor, Bureau of Labor Statistics, 2004. Employer Costs for Employee Compensation  December 2003. February 26, 2004.

3 INDUSTRY GOVERNMENT $ 31,162.43 $ 10,704.59 651.71 hours 120.75 hours The methodology and the burden and cost details are discussed in the following sections.

2.0 METHODOLOGY AND DATA SOURCES 2.1 Burden Hour Estimates The primary source of burden hour and direct cost estimates in this report are previous economic analyses performed for the PAIR rule1. All burden hour and cost estimations in this analysis are directly from previous PAIR analyses unless otherwise noted.

2.2 Wage Rates and Cost Estimation Wage rates including fringe benefits and overhead for three broad categories of labor ( managerial, technical, and clerical) were used in this cost analysis. The labor categories and the method for determining loaded wage rates were developed during previous studies2. The basis for estimating wage rates for these purposes is the Bureau of Labor Statistics ( BLS) wage data for comparable labor categories. The BLS now reports this data on a quarterly basis, allowing nearcurrent wages to be used in this analysis.

The December 2003 loaded hourly wage rates used in the analysis are presented in Table 2. Unit burden estimates are converted to unit cost estimates by multiplying the unit burden hours by the appropriate wage rates in Table 2.

Wage data used in developing the basic wage rates for this analysis were derived from December 2003 wage information published by the Bureau of Labor Statistics ( BLS) for all goods producing, private industries3. The managerial wage rates are taken from the BLS data for the executive, administrative, and managerial occupational group. The technical wage rates are taken from BLS data for the professional specialty and technical occupational group. The clerical wage rates are taken from the BLS data for the administrative support ( including clerical) occupational group. Based on that BLS data, the average hourly wage rates are $ 32.90 for 4 managerial personnel, $ 28.36 for technical personnel, and $ 15.09 for clerical personnel, all in December 2003 dollars.

The benefits loading factors are calculated from the BLS data on the cost of benefits for each labor category. An additional loading of 17 percent of the average hourly wage is added for overhead. The overhead factor of 17 percent is based on information provided by the chemical industry and chemical industry trade associations. The loaded hourly wage rates are $ 53.82 for managerial personnel, $ 46.09 for technical personnel, and $ 24.46 for clerical personnel, all in December 2003 dollars.

TABLE 2: LOADED HOURLY WAGE RATES BY LABOR CATEGORY Labor Category December 2003 Average Wages December 2003 Benefits and Overhead Loading Factor December 2003 Loaded Hourly Rate Managerial $ 32.90 1.636 $ 53.82 Technical $ 28.36 1.625 $ 46.09 Clerical $ 15.09 1.621 $ 24.46 Sources: U. S. Environmental Protection Agency, 2002. Wage Rates for Economic Analyses of the Toxics Release Inventory Program. Cody Rice, Analytical Support Branch, Office of Environmental Information. June 10, 2002. U. S. Department of Labor, Bureau of Labor Statistics, 2004. Employer Costs for Employee Compensation  December 2003. February 26, 2004.

3.0 INDUSTRY BURDEN AND COST ESTIMATES Compliance with this reporting rule will require the following activities:

 Form Familiarization;  Report completion;  CBI Substantiation;  Tradename notification, and;  Report submission.

This section estimates the burden and cost of the rule to industry. The unit burden and unit cost of each major activity is discussed below.

3.1 Form Familiarization All plant sites will need to familiarize themselves with EPA's published standard reporting form and reporting requirements. The burden and costs for form familiarization are assumed to be incurred on a unique plant site since many of the same site staff would familiarize themselves with the reporting form regardless of the number of site specific chemicals to be reported.

It is estimated that form familiarization will require about 3 hours of managerial time and 4 hours of technical personnel effort. The per site unit burden and unit cost is 7 hours and $ 345.81, respectively. There are no other direct costs ( ODCs). The specific unit burden and unit costs are summarized as follows. 5 Site Activity Clerical Technical Managerial ODCs Total Burden 0.00 4.00 3.00  7.00 Cost $ 0.00 $ 184.34 $ 161.47 $ 0.00 $ 345.81 3.2 Report Completion Report completion requires collecting, analyzing, transcribing, and reviewing the information necessary to fully respond to the requirements of the reporting rule. Report completion accounts for over half of the burden of the rule on industry.

The estimated average burden for the completion of a single report is 16 hours. The per report cost is estimated to be $ 752.90. This estimate does not include claims of CBI ( Section I), or tradename notification ( Section IV, Part B, item 10).

Report Activity Clerical Technical Managerial ODCs Total Burden 1.25 9.25 5.5  16.00 Cost $ 30.58 $ 426.29 $ 296.03 $ 0.00 $ 752.90 3.3 CBI Substantiation In Section I of the standard PAIR form, the reporting firm may make claims of confidentiality for any data element contained in their submission. It is assumed that most of the time required for CBI substantiation involves managerial staff discussion of whether or not to make a CBI claim. Four hours of managerial labor and one half hour of clerical labor are required for CBI substantiation. The total unit costs is, therefore, estimated to be $ 227.53 per report. It is assumed that 75% of reports contain CBI claims, so for this analysis 17.25 CBI reports are estimated.

Report Activity Clerical Technical Managerial ODCs Total Burden 0.50 0.00 4.00  4.50 Cost $ 12.23 $ 0.00 $ 215.30 $ 0.00 $ 227.53 3.4 Tradename Notification In Section IV, Part B of the PAIR standard form, some companies may report their customer's uses as unknown for more than twenty percent of their total volume. These companies must list under item 10 the trade names under which they distribute the chemical. The unit costs per report is $ 142.87. It is assumed that thirty percent of PAIR reporting sites report these tradenames, so for this analysis 6.9 tradename sites are estimated. 4 These costs include $ 3.85 in postage ( USPS Priority Mail, up to one pound), and $ 0.20 in photocopying costs ( 4 pages at $ 0.05 per page.

6 Report Activity Clerical Technical Managerial ODCs Total Burden 1.00 0.00 2.20  3.20 Cost $ 24.46 $ 0.00 $ 118.41 $ 0.00 $ 142.87 3.5 Report Submission These costs cover the expense to review, copy, and mail the PAIR form to EPA. Report submission will require 0.5 hours of clerical time and 0.5 hours of managerial time per report. The clerical burden includes the time required to photocopy and mail the report package. The managerial time is for review of the report package before it is submitted to EPA. These burden categories are estimated to cost $ 39.14 per report; but do not include other direct costs. Other direct costs ( photocopying and mailing costs) are estimated to total $ 4.05 ( current dollars) per report4. Thus, the total report submission costs will be $ 43.19 per report ( i. e., $ 39.14 + $ 4.05).

Report Activity Clerical Technical Managerial ODCs Total Burden 0.50 0.00 0.50 0.00 1.00 Cost $ 12.23 $ 0.00 $ 26.91 $ 4.05 $ 43.19 3.6 Total Industry Burden and Cost Summary information on total unit burden and unit cost under the reporting rule is presented in Tables 3 and 4.

The total industry burden and costs are based on the expected level reporting activity which, in turn, is related to the number of reports and reporting sites. The number of reports and reporting sites depends upon the number of manufacturers and importers and their number of sites for each chemical subjected to the reporting rule. These variables, summarized in Table 5, are applied to the unit burden and cost estimates as shown in Table 6 to generate an estimate of total industry burden and costs. The total industry burden and costs are, respectively, 651.71 hours and $ 31,162.43. The unit burden per site/ report is 28.3 hours, and the unit costs per site/ report are $ 1,354.89, as shown in Table 6. 7 Table 3: Unit Burden ( hours) of PAIR Reporting Activity Clerical Technical Managerial Total PER SITE Form Familiarization 0.00 4.00 3.00 7.00 PER REPORT Report Completion CBI Substantiation\ 1 Tradename Notification\ 2 Report submission 1.25 0.50 1.00 0.50 9.25 0.00 0.00 0.00 5.50 4.00 2.20 0.50 16.00 4.50 3.20 1.00 \ 1 Assumes site claims CBI. Only 75% of sites are estimated to claim CBI. \ 2 Assumes site reports tradenames. Only 30% of sites are estimated to report tradenames.

Table 4: Unit Costs ( Dec. 2003$) of PAIR Reporting Activity Clerical Technical Managerial ODC Total PER SITE Form Familiarization $ 0.00 $ 184.34 $ 161.47 $ 0.00 $ 345.81 PER REPORT Report Completion CBI Substantiation\ 1 Tradename Notification\ 2 Report submission $ 30.58 $ 12.23 $ 24.46 $ 12.23 $ 426.29 $ 0.00 $ 0.00 $ 0.00 $ 296.03 $ 215.30 $ 118.41 $ 26.91 $ 0.00 $ 0.00 $ 0.00 $ 4.05 $ 752.90 $ 227.53 $ 142.87 $ 43.19 \ 1 Assumes site claims CBI. Only 75% of sites are estimated to claim CBI. \ 2 Assumes site reports tradenames. Only 30% of sites are estimated to report tradenames.

Table 5: Summary of Reporting Requirements Multipliers UNIT VARIABLE QUANTITY DESCRIPTION / COMMENTS Number of Chemicals 23 EPA Supplied.

Number of Manufacturers/ Importers 23 EPA Assumption.

Number of Reporting Sites 23 EPA Assumption.

Number of Reports 23 Assumes one report per chemical per site.

Number of Reports with Tradenames 6.9 Assumes 30% of reports.

Number of Reports with CBI Claims 17.25 Assumes 75% of reports. 5 Data processing costs for the 1992 PAIR ICR update was estimated to be approximately $ 177 per report. Adjusting this number with the GNP implicit price deflator for 2003( 4)/ 1991( 4) ( from Survey of Current Business, March 2004) yields an adjusted data processing cost of $ 220.53 per report ( i. e., $ 177 * ( 106.16/ 85.21) = $ 220.53).

6 It has been derived from the 1989 PAIR ICR update that industry/ public assistance required approximately 1.5 hours per report ( or 0.00072 FTEs per report) and data processing/ system support personnel required about 3.75 hours per report ( or 0.0018 FTEs per report). Other government activities associated with PAIR are not affected ( Chemical Nomination, Review and Selection; Rule Development; Rule Evaluation; Compliance Monitoring).

7 The annual costs per FTE are derived by multiplying the annual pay rate by 1.6 ( the benefits multiplication factor). The multiplication factor used is recommended in EPA's Office of Policy, Planning, and Evaluation's Instructions for Preparing Information Collection Requests ( ICRs) ( June 1, 1992). The 1.6 factor includes not only benefits but also overhead. An annual pay rate of $ 60,638 is used and reflects a GS 12 ( level 1) salary with Washington D. C. locality pay, as of January 2004. This GS 12, Step 1, assumption was recommended by EPA. ( Internal EPA phone call between Carol Rawie ( OPPT/ EETD/ RIB) and Ron Carlson ( OPPT/ OPME) on April 25, 1994). Thus, the annual, fully loaded cost per FTE is $ 97,021 ( or $ 60,638 * 1.6).

8 Table 6: Total Industry Burden and Costs ( 2002$) of the Reporting Rule Activity Unit Burden Unit Costs Units Total Burden Total Costs PER SITE Form Familiarization 7.00 $ 345.81 23 161.00 $ 7,953.63 PER REPORT Report Completion CBI Substantiation Tradename Notification Report submission 16.00 4.50 3.20 1.00 $ 752.90 $ 227.53 $ 142.87 $ 42.67 23 17.25 6.9 23 368.00 77.63 22.08 23.00 $ 17,316.70 $ 3,924.80 $ 985.80 $ 981.41 TOTAL $ 1,511.78\ 1 651.71 $ 31,162.43 Unit Burden of this Rule Per Site/ Report 651.7 total hours / 23 total sites/ reports = 28.3 hours Unit Cost of this Rule per Site/ Report $ 31,162.43 total cost / 23 total sites/ reports = $ 1,354.89 \ 1 This figure represents the maximum potential impact for any one firm.

4.0 GOVERNMENT BURDEN AND COST ESTIMATES The estimated cost of this reporting rule to the Federal government is provided on an annual basis. The 2004 cost of a full time equivalent employee ( FTE) at EPA was provided by the Office of Personnel Management. One FTE is equivalent to 2,080 hours per year.

This reporting rule estimates that a total of 23 reports will be submitted. The base cost for data processing was adjusted to reflect this rule's expected number of report submissions5. Personnel costs associated with industry assistance and data processing activities have been similarly adjusted6. These adjustments were carried through in this analysis.

Table 8 summarizes the Government's activities in developing and administering this reporting rule. The required FTEs per activity are retained from previous PAIR ICRs update except where noted. The cost for data processing per report is $ 220.53. Therefore, it is estimated that the annual cost to the Federal Government will be $ 5,072.24 ( 23 reports * $ 220.53), plus 0.0581 FTEs. At an estimated $ 97,021 per FTE7, the total of 0.0581 FTEs will cost EPA $ 5,632.35 in salaries, bringing the total costs to the Federal government to $ 10,704.59 ( i. e., $ 5,072.24 + $ 5,632.35). 9 Table 7: Total Government Burden and Costs ( December 2003$)

Activity Unit Burden Total Burden Industry/ Public Assistance Data Processing / System Support Personnel TOTAL ACTIVITY BURDEN 1.5 hours/ report 3.75 hours/ report 0.0166 FTE 0.0415 FTE 0.0581 FTE ( 120.75 hours)

Loaded Annual Costs per FTE $ 97,021 TOTAL ACTIVITY COSTS ($ 97,021 * 0.0581 FTE) $ 5,632.35 Data Processing costs ($ 220.53 * 23 reports) $ 5,072.24 TOTAL ANNUAL GOVERNMENT COSTS $ 10,704.59 5.0 REGULATORY FLEXIBILITY ACT Under the Regulatory Flexibility Act ( RFA) and the Small Business Regulatory Enforcement Fairness Act ( SBREFA), EPA is required to consider whether a regulatory action will have a significant adverse impact on small entities. Both the RFA and SBREFA require EPA to determine whether a rulemaking may result in " significant economic impact on a substantial number of small entities," and if so, to tailor the requirements of the rule to mitigate such impacts, while still maintaining a high level of environmental protection.

The small business size standards promulgated by the Small Business Administration ( SBA) ( 61 FR 3280, 3289 3291, January 31, 1996) for chemical manufacturers are based solely on the number of employees, with a base threshold of 1,000 employees for the ultimate corporate parent, under which all businesses are considered small. Of the 23 businesses assumed to be affected by this rule, it is unknown how many meet this definition of small business.

To estimate the impact of the rule on a business, the preferred method is the " sales test," wherein costs for any individual firm are measured as a percent of annual sales. At a maximum cost for any one firm of $ 1,511.78, the firm's total sales would have to be less than $ 160,000 for this rule to have an impact of even 1% of sales. Thus, EPA has determined that this rule will not impose a significant impact on a substantial number of small entities.


[Federal Register Volume 87, Number 23 (Thursday, February 3, 2022)]
[Notices]
[Pages 6161-6162]
[FR Doc No: 2022-02153]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2212-055]

Domtar Paper Company, LLC; Notice of Application Accepted for
Filing and Soliciting Comments, Motions To Intervene, and Protests

    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Non-Capacity Amendment of License.
    b. Project No.: 2212-055.
    c. Date Filed: November 22, 2021.
    d. Applicant: Domtar Paper Company, LLC.
    e. Name of Project: Rothschild Hydroelectric Project.
    f. Location: The project is located on the Wisconsin River in
Marathon County, Wisconsin.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791a-825r.
    h. Applicant Contact: Mr. Steven Lewens, Environmental Health &
Safety Manager-Rothschild, Domtar Paper Company, LLC, 200 North Grand
Avenue, Rothschild, WI 54474;<PHONE_NUMBER>; [email protected].
    i. FERC Contact: Linda Stewart,<PHONE_NUMBER>,
[email protected].
    j. Deadline for filing comments, motions to intervene, and
protests: February 28, 2022.
    The Commission strongly encourages electronic filing. Please file
comments, motions to intervene, and protests using the Commission's
eFiling system at http://www.ferc.gov/docs-filing/efiling.asp.
Commenters can submit brief comments up to 6,000 characters, without
prior registration, using the eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You must include your name and contact
information at the end of your comments. For assistance, please contact
FERC Online Support at [email protected],<PHONE_NUMBER> (toll
free), or<PHONE_NUMBER> (TTY). In lieu of electronic filing, you may
submit a paper copy. Submissions sent via the U.S. Postal Service must
be addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852. The first page of any filing should
include the docket number P-2212-055. Comments emailed to Commission
staff are not considered part of the Commission record.
    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 whose name appears on 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, it
must also

serve a copy of the document on that resource agency.
    k. Description of Request: Domtar Paper Company, LLC (licensee) has
determined that the repair of five inoperable turbine generating units
(Units 1, 2, 4, 5, and 6) is not cost effective, and therefore,
proposes to retire the five units in place. The other two turbine
generating units at the project (Units 3 and 7) would remain in
service, with no changes proposed by the licensee. To retire the five
units, the licensee proposes to disconnect the generator leads from the
units. All proposed activity would occur in the powerhouse, with no
ground disturbing activity necessary. With both the powerhouse and the
spillway section of the dam currently releasing flows into the main
channel of the Wisconsin River downstream, the proposal would result in
a reduced flow through the powerhouse and an increased flow over the
spillway. The proposal would decrease the total authorized capacity of
the project from 3,708 to 948 kilowatts and would decrease the
hydraulic capacity from 3,850 to 1,100 cubic feet per second.
    l. Locations of the Application: This filing may be viewed on the
Commission's website 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. You may also register
online at http://www.ferc.gov/docs-filing/esubscription.asp to be
notified via email of new filings and issuances related to this or
other pending projects. For assistance, call 1-866-208-3676 or email
[email protected], for TTY, call<PHONE_NUMBER>. Agencies may
obtain copies of the application directly from the applicant.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. 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, respectively. 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.
    o. Filing and Service of Documents: Any filing must (1) bear in all
capital letters the title ``COMMENTS'', ``PROTEST'', or ``MOTION TO
INTERVENE'' as applicable; (2) set forth in the heading the name of the
applicant and the project number of the application to which the filing
responds; (3) furnish the name, address, and telephone number of the
person commenting, protesting, or intervening; and (4) otherwise comply
with the requirements of 18 CFR 385.2001 through 385.2005. All
comments, motions to intervene, or protests must set forth their
evidentiary basis. Any filing made by an intervenor must be accompanied
by proof of service on all persons listed in the service list prepared
by the Commission in this proceeding, in accordance with 18 CFR
385.2010.

    Dated: January 27, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-02153 Filed 2-2-22; 8:45 am]
BILLING CODE 6717-01-P


U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2000. Supporting Statement for EPA ICR No. 1139.06: TSCA Existing Chemical Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary Test Data Submissions.
U.S. Environmental Protection Agency (EPA), Office of Pollution Prevention and Toxics. 2002a. Economic Analysis for the Amended Inventory Update Rule: Final Report. EPA-HQ-OPPT-2002-0054-0260.
U.S. Environmental Protection Agency (EPA). Office of Pollution, Prevention and Toxics. 2002b. Wage Rates for Economic Analyses of the Toxics Release Inventory Program.
U.S. Environmental Protection Agency (EPA). 2004. Cross-Media Electronic Reporting Rule (CROMERR) Cost Benefit Analysis. Final. Washington, DC. November 17, 2004
U.S. Environmental Protection Agency (EPA). 2007a. TSCA Section 4 Test Rules, Consent Orders, Test Rule Exemptions, and Voluntary Data Submission. ICR No.: 1139.08. OMB Control No.: 2070-0033.
U.S. Environmental Protection Agency (EPA). 2007b. TSCA Section 8(a) Preliminary Assessment Information Rule (PAIR). ICR No.: 0586.11. OMB Control No.: 2070-0054
U.S. Environmental Protection Agency (EPA). 2007c. Health and Safety Data Reporting, Submission of Lists and Copies of Health and Safety Studies. ICR No.: 0575.12. OMB Control No.: 2070-0004.
U.S. Environmental Protection Agency (EPA). 2009. Economic Analysis of the Premanufacture Notification Electronic Reporting Final Rule. EPA-HQ-OPPT-2008-0296-0009.
U.S. Environmental Protection Agency (EPA). 2010b. "Data Development (Testing). Accessed November 16, 2010. Available at: http://www.epa.gov/oppt/chemtest/pubs/data.html.
U.S. Environmental Protection Agency (EPA). 2010c. "General Information Gathering Authority." Accessed November 16, 2010. Available at: http://www.epa.gov/opptintr/chemtest/pubs/sect8a.html.
U.S. Environmental Protection Agency (EPA). 2010d. "Unpublished Health and Safety Studies." Accessed November 16, 2010. Available at: http://www.epa.gov/opptintr/chemtest/pubs/sect8d.html.
U.S. Environmental Protection Agency (EPA). 2010e. "Find Section 8(e) and `For Your Information' (FYI) Submissions." Accessed November 16, 2010. Available at: http://www.epa.gov/opptintr/tsca8e/pubs/8eandfyisubmissions.html.
U.S. Office of Personnel Management (OPM). 2009. "Salary Table 2009 for the Locality Pay Area of Washington-Baltimore-Northern Virginia, DC-MD-VA-WV-PA." Effective January 2009. Available at: http://www.opm.gov/oca/09tables/pdf/DCB.pdf. Accessed October 08, 2009.
Staples, 2010. "Staples Copy Paper." Accessed November 16, 2010. Available at: http://www.staples.com/Staples-Copy-Paper/product_SS122457.
U.S. Postal Service (USPS). 2009.
Weinstein, Harriet G and Mark A. Loewenstein. U.S. Bureau of Labor Statistics (BLS). 2004. "Comparing Current and Former Industry and Occupation ECEC Series." Available at: http://www.bls.gov/opub/cwc/cm20040823ar01p1.htm. Accessed October 08, 2009.
White House Office of Management and Budget (OMB). 2003. Circular A-4. Available at: http://www.whitehouse.gov/omb/circulars/a004/A-4.html. Accessed October 08, 2009.


[Federal Register: July 24, 2006 (Volume 71, Number 141)]
[Notices]
[Page 41789]
[DOCID:fr24jy06-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. ER06-885-000; ER06-885-001]

BM2 LLC; Notice of Issuance of Order

July 13, 2006.
    BM2 LLC (BM2) filed an application for market-based rate authority,
with an accompanying rate schedule. The proposed market-based rate
schedule provides for the sale of energy and capacity at market-based
rates. BM2 also requested waivers of various Commission regulations. In
particular, BM2 requested that the Commission grant blanket approval
under 18 CFR part 34 of all future issuances of securities and
assumptions of liability by BM2.
    On July 13, 2006, pursuant to delegated authority, the Director,
Division of Tariffs and Market Development--West, granted the requests
for blanket approval under Part 34. The Director's order also stated
that the Commission would publish a separate notice in the Federal
Register establishing a period of time for the filing of protests.
Accordingly, any person desiring to be heard or to protest the blanket
approvals of issuances of securities or assumptions of liability by BM2
should file a motion to intervene or protest with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in
accordance with Rules 211 and 214 of the Commission's Rules of Practice
and Procedure. 18 CFR 385.211, 385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is August 14, 2006.
    Absent a request to be heard in opposition by the deadline above,
BM2 is authorized to issue securities and assume obligations or
liabilities as a guarantor, indorser, surety, or otherwise in respect
of any security of another person; provided that such issuance or
assumption is for some lawful object within the corporate purposes of
BM2, compatible with the public interest, and is reasonably necessary
or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of BM2's issuances of securities or assumptions of
liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also 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
filed to access the document. 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.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-11653 Filed 7-21-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 7 (Tuesday, January 12, 2016)]
[Notices]
[Pages 1426-1428]
[FR Doc No: 2016-00328]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-N-4990]

Next Generation Sequencing-Based Oncology Panels; Public
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Next Generation Sequencing-Based Oncology Panels.''
The purpose of this workshop is to obtain feedback on analytical and
clinical validation approaches for next generation sequencing (NGS)-
based oncology panels. Comments and suggestions generated through this
workshop will help guide the development of appropriate regulatory
standards for evaluation of NGS-based oncology panels in cancer patient
management.

DATES: The public workshop will be held on February 25, 2016, from 8:30
a.m. to 5 p.m. Submit either electronic or written comments on the
public workshop by March 28, 2016.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31, Rm. 1503 B and C (the Great Room),
Silver Spring, MD 20993. Entrance for the public workshop participants
(non-FDA employees) is through Building 1 where routine security check
procedures will be performed. For parking and security information,
please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2015-N-4990 for ``Next Generation Sequencing-Based Oncology
Panels.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Jennifer Dickey, Center for Devices
and Radiological Health, Food and Drug Administration, Bldg. 66, Rm.
5648, 10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
I. Background

    A number of oncology therapeutic products have been approved with
corresponding companion diagnostics (Ref. 1). To date, approved
companion diagnostic assays assess a single analyte or prespecified
mutations associated with therapeutic response; however, NGS technology
can interrogate a patient's tumor specimen for numerous biomarkers
concurrently, introducing challenges to the current companion
diagnostic paradigm. Additionally, NGS tumor panels are increasingly
employed for use in similar oncology applications because the
technology can be used to screen a cancer patient's specimen for many
relevant mutations simultaneously.
    FDA is holding this public workshop to solicit input from external
stakeholders on approaches to establish performance characteristics of
NGS-based oncology panels that include variants that are intended to be
used as companion diagnostics, as well as other variants that may be
used for alternative therapeutic management of patients who have
already been considered for all appropriate therapies. The Agency is
requesting public input on strategies for establishing performance
characteristics for NGS-based oncology panels for rare variants across
tumor types, follow-on companion diagnostic claims, and post-approval
assay modifications. Further details to be considered and discussed at
the workshop will be outlined in a discussion paper that will be posted
publicly and available prior to the workshop at the following site:
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

II. Topics for Discussion at the Public Workshop

    This public workshop will consist of brief presentations to provide
information to frame the goals of the workshop and interactive
discussions via several panel sessions. Following the presentations,
there will be a moderated discussion where speakers and additional
panelists will be asked to provide their individual perspectives. The
presentations and discussions will focus on several topics, including a
description of a hypothetical NGS-based oncology panel test and its
general intended use; considerations for pre-analytical and quality
metric approaches; challenges in analytical validation and the
potential for development of a flexible approach for post-approval
assay modifications; and the framework for clinical and follow-on
companion diagnostic claims. In advance of the meeting, FDA plans to
post a discussion paper outlining FDA's current thinking for NGS-based
oncology panels and the issues for discussion at the workshop at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)
FDA will place the discussion paper on file in the public docket
(docket number found in brackets in the heading of this document) and
will post it at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. The deadline for submitting comments
on this document for presentation at the public workshop is February 2,
2016, although comments related to this document can be submitted until
March 28, 2016. A detailed agenda will be posted on this Web site in
advance of the workshop.
    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending this public
workshop must register online by 4 p.m. on February 17, 2016. Early
registration is recommended because facilities are limited and,
therefore, FDA may limit the number of participants from each
organization. If time and space permits, onsite registration on the day
of the public workshop will be provided beginning at 7:30 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health,
Office of Communication and Education, phone<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>no later than 4 p.m. on February 11,
2016.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this meeting/public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, email, and telephone number. Those
without Internet access should contact Susan Monahan to register (see
special accommodations contact). Registrants will receive confirmation
after they have been accepted. You will be notified if you are on a
waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. The Webcast link will be available on the registration
Web page after February 17, 2016. Please visit FDA's Medical Devices
News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select
this meeting/public workshop from the posted events list.) If you have
never attended a Connect Pro event before, test your connection at
https://collaboration.fda.gov/common/help/en/support/meeting_test.htm.
To get a quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. (FDA has verified the Web site
addresses in this document, but FDA is not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    Requests for Oral Presentations: This public workshop includes a
public comment session. During online registration you may indicate if
you wish to present during a public comment session, and which topics
you wish to address. FDA has included general topics in this document
which will be addressed in greater detail in a

subsequent discussion paper (see SUPPLEMENTARY INFORMATION). FDA will
do its best to accommodate requests to make public comment. Individuals
and organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation, or submit requests for designated representatives to
participate in the focused sessions. All requests to make oral
presentations must be received by February 2, 2016. FDA will determine
the amount of time allotted to each presenter and the approximate time
each oral presentation is to begin, and will select and notify
participants by February 8, 2016. If selected for presentation, any
presentation materials must be emailed to Jennifer Dickey (see FOR
FURTHER INFORMATION CONTACT) no later than February 16, 2016, at 4 p.m.
No commercial promotional material will be permitted to be presented or
distributed at this public workshop.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information Office address is available on the Agency's Web site at
http://www.fda.gov. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list.)

III. Reference

    The following reference is on display in the Division of Dockets
Management (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also
available electronically at http://www.regulations.gov. FDA has
verified the Web site address, as of the date this document publishes
in the Federal Register, but Web sites are subject to change over time.
    1. Please refer to FDA's Web site on companion diagnostics,
available at http://www.fda.gov/companiondiagnostics.

    Dated: January 5, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-00328 Filed 1-11-16; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 58 (Monday, March 27, 2023)]
[Proposed Rules]
[Pages 18104-18106]
[FR Doc No: 2023-06179]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0205]
RIN 1625-AA00

Safety Zone; Fireworks Display, Yaquina Bay, Newport, OR

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard is proposing to establish a temporary safety
zone for certain waters of Yaquina Bay. This action is necessary to
provide for the safety of life on these navigable waters near Newport,
OR, during a fireworks display on July 4, 2023. This proposed
rulemaking would prohibit persons and vessels from being in the safety
zone unless authorized by the Captain of the Port Columbia River or a
designated representative. We invite your comments on this proposed
rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before April 26, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2023-0205 using the Federal Decision-Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email LT Carlie Gilligan, Waterways
Management Division, Marine Safety Unit Portland, Coast Guard;
telephone<PHONE_NUMBER>, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port Columbia River
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    On February 6, 2023, Western Display Fireworks, LTD notified the
Coast Guard that it will be conducting a fireworks display from 10 to
10:30 p.m. on July 4, 2023. The fireworks are to be launched from a
site on land in the Port of Newport, OR. Hazards from firework displays
include accidental discharge of fireworks, dangerous projectiles, and
falling hot embers or other debris. The Captain of the Port Columbia
River (COTP) has determined that potential hazards associated with the
fireworks would be a safety concern for anyone within a 500-foot radius
of the launch site before, during, or after the fireworks display.
    The purpose of this rulemaking is to ensure the safety of vessels
and the navigable waters within a 500-foot radius of the fireworks
discharge site before, during, and after the scheduled event. The Coast
Guard is proposing this rulemaking under authority in 46 U.S.C. 70034
(previously 33 U.S.C. 1231).

III. Discussion of Proposed Rule

    The COTP is proposing to establish a safety zone from 9:30 to 11
p.m. on July 4, 2023. The safety zone would cover all navigable waters
within 500 feet of the launch site located at approximately
44[deg]37'31'' N 124[deg]2'5'' W in the port of Newport, Oregon. The
duration of the zone is intended to ensure the safety of vessels and
these navigable waters before, during, and after the scheduled 10 to
10:30 p.m. fireworks display. No vessel or person would be permitted to
enter the safety zone without obtaining permission from the COTP or a
designated representative. The regulatory text we are proposing appears
at the end of this document.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders, and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This NPRM has not been designated a ``significant
regulatory action,'' under Executive Order 12866. Accordingly, the NPRM
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, and duration of the safety zone. The safety zone created by
this proposed rule is designed to minimize its impact on navigable
waters. The safety zone will impact approximately a 500-foot area of
Yaquina Bay and is not anticipated to exceed 2 hours in duration. Thus,
restrictions on vessel movement within that particular area are
expected to be minimal. Moreover, under certain conditions vessels may
still transit through the safety zone when permitted by the COTP. The
Coast Guard would issue a Notice to Mariners about the zone, and the
rule would allow vessels to seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this proposed rule
would have a significant economic impact on it, please submit a comment
(see ADDRESSES) explaining why you think it qualifies and how and to
what degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the proposed rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call or email the person listed in the
FOR FURTHER INFORMATION CONTACT section. The Coast Guard will not
retaliate against small entities that question or complain about this
proposed rule or any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132
(Federalism), if it has a substantial direct effect 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175 (Consultation and Coordination with Indian Tribal
Governments) because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the potential effects of
this proposed rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, Rev. 1, associated implementing
instructions, and Environmental Planning COMDTINST 5090.1 (series),
which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (42 U.S.C. 4321-4370f), and have made
a preliminary determination that this action is one of a category of
actions that do not individually or cumulatively have a significant
effect on the human environment. This proposed rule involves a safety
zone lasting 1.5 hours that would prohibit entry within 400 feet of a
fireworks launch site. Normally such actions are categorically excluded
from further review under paragraph L60(a) of Appendix A, Table 1 of
DHS Instruction Manual 023-01-001-01, Rev. 1. A preliminary Record of
Environmental Consideration supporting this determination is available
in the docket. For instructions on locating the docket, see the
ADDRESSES section of this preamble. We seek any comments or information
that may lead to the discovery of a significant environmental impact
from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision-Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2023-0205 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this proposed rule for alternate
instructions.
    Viewing material in docket. To view documents mentioned in this
proposed rule as being available in the docket, find the docket as
described in the previous paragraph, and then select ``Supporting &
Related Material'' in the Document Type column. Public comments will
also be placed in our online docket and can be viewed by following
instructions on the https://www.regulations.gov Frequently Asked
Questions web page. Also, if you click on the Dockets tab and then the
proposed rule, you should see a ``Subscribe'' option for email alerts.
The option will notify you when comments are posted, or a final rule is
published.
    We review all comments received, but we will only post comments
that address the topic of the proposed rule. We may choose not to post
off-topic, inappropriate, or duplicate comments that we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard is
proposing to amend 33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051, 70124; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Add Sec.  165.T13-0205 to read as follows:

Sec.  165.T13-0205  Safety Zone; Fireworks Display, Yaquina Bay,
Newport, OR.

    (a) Location. The following area is a safety zone: All navigable
waters within 500 feet of a fireworks launch site in Newport, OR. The
fireworks launch site will be at the approximate point of
44[deg]37'31.62'' N/124[deg]2'5.42'' W.
    (b) Definitions. As used in this section--
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port Columbia River
(COTP) in the enforcement of the safety zone.
    Participant means all persons and vessels registered with the event
sponsor as a participant in the fireworks display.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, all non-participants may not enter the safety
zone described in paragraph (a) of this section unless authorized by
the COTP or the COTP's designated representative.

    (2) To seek permission to enter, contact the COTP or the COTP's
representative by calling<PHONE_NUMBER> or the Sector Columbia River
Command Center on Channel 16 VHF-FM. Those in the safety zone must
comply with all lawful orders or directions given to them by the COTP
or the COTP's designated representative.
    (3) The COTP will provide notice of the regulated area through
advanced notice via broadcast notice to mariners and by on-scene
designated representatives.
    (d) Enforcement period. This section will be enforced from 9:30 to
11 p.m. on July 4, 2023. It will be subject to enforcement this entire
period unless the COTP determines it is no longer needed, in which case
the Coast Guard will inform mariners via Notice to Mariners.

    Dated: March 20, 2023.
M. Scott Jackson,
Captain, U.S. Coast Guard, Captain of the Port, Sector Columbia River.
[FR Doc. 2023-06179 Filed 3-24-23; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: April 9, 2010 (Volume 75, Number 68)]
[Rules and Regulations]
[Page 18058-18061]
[DOCID:fr09ap10-8]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2010-0133]
RIN 1625-AA00

Safety Zone; Patapsco River, Northwest and Inner Harbors,
Baltimore, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone upon
certain waters of the Patapsco River, Northwest Harbor and Inner Harbor
during the movement of the historic sloop-of-war USS CONSTELLATION on
May 27, 2010. This action is necessary to provide for the safety of
life on navigable waters during the tow of the vessel from its berth at
the Inner Harbor in Baltimore, Maryland, to a point on the Patapsco
River near the Fort McHenry National Monument and Historic Shrine in
Baltimore, Maryland, and its return. This action will restrict vessel
traffic in portions of the Patapsco River, Northwest Harbor, and Inner
Harbor during the event.

DATES: This rule is effective from 2 p.m. May 27, 2010 through 7 p.m.
June 3, 2010.

ADDRESSES: Documents indicated in this preamble as being available in
the docket are part of docket USCG-2010-0133 and are available online
by going to http://www.regulations.gov, inserting USCG-2010-0133 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail Mr. Ronald Houck, Sector Baltimore
Waterways Management Division, Coast Guard; telephone<PHONE_NUMBER>, e-
mail<EMAIL_ADDRESS>If you have questions on viewing the
docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Regulatory Information

    The Coast Guard is issuing this temporary final rule without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is contrary to public interest to
delay the effective date of this rule. Delaying the effective date
would be contrary to the safety zone's intended objectives since
immediate action is needed to protect persons and vessels against the
hazards associated with the movement of an historic vessel being towed
on confined navigable waters. Such hazards include damages and injuries
caused by collisions with other vessels and navigational obstructions
and hazards caused by vessel sinkings.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Due to the need for immediate
action, the restriction of vessel traffic is necessary to protect life,
property and the environment; therefore, a 30-day notice is
impracticable. Delaying the effective date would be contrary to the
safety zone's intended objectives of protecting persons and vessels
involved in the event, and enhancing public and maritime safety.

Background and Purpose

    The Historic Ships in Baltimore Museum is planning to conduct a
``turn-around'' ceremony involving the sloop-of-war USS CONSTELLATION
in Baltimore, Maryland on Thursday, May 27, 2010. Planned events
include a three-hour, round-trip tow of the USS CONSTELLATION in the
Port of Baltimore, with an onboard salute with navy pattern cannon
while the historic vessel is positioned off Fort McHenry National
Monument and Historic Site. Beginning at 3 p.m., the historic Sloop-of-
War USS CONSTELLATION will be towed ``dead ship,'' which means that the
vessel will be underway without the benefit of mechanical or sail
propulsion.

The return dead ship tow of the USS CONSTELLATION to its berth in the
Inner Harbor is expected to occur immediately upon execution of a tug-
assisted turn-around of the USS CONSTELLATION on the Patapsco River
near Fort McHenry. The Coast Guard anticipates a large recreational
boating fleet during this event, scheduled on a late Thursday afternoon
during the Memorial Day Holiday weekend in Baltimore, Maryland.
Operators should expect significant vessel congestion along the planned
route. In the event of inclement weather, the ``turn-around'' will be
rescheduled on Thursday, June 3, 2010.
    To address safety concerns during the event, the Captain of the
Port, Baltimore, Maryland is establishing a safety zone upon certain
waters of the Patapsco River, Northwest Harbor and Inner Harbor. The
safety zone will help the Coast Guard provide for a clear transit route
for the participating vessels, and provide a safety buffer around the
participating vessels while they are in transit. Due to the need to
promote maritime safety and protect participants and the boating public
in the Port of Baltimore immediately prior to, during, and after the
scheduled event, a temporary safety zone is necessary for this type of
event.

Discussion of Rule

    A regulation establishing a permanent safety zone for this annual
event, with an enforcement period from 2 p.m. through 7 p.m. annually
on the Friday following Labor Day, has already been published and is
detailed at 33 CFR 165.512. However, due to a change in scheduling for
this calendar year, this event is planned for Thursday, May 27, 2010.
The historic sloop-of-war USS CONSTELLATION is scheduled to be towed
``dead ship'' from its berth at Pier 1 in Baltimore's Inner Harbor to a
point on the Patapsco River near Fort McHenry National Monument and
Historic Shrine, Baltimore, Maryland, along a one-way, planned route of
approximately four nautical miles, that includes specified waters of
the Patapsco River, Northwest Harbor and Inner Harbor. After being
turned-around, the USS CONSTELLATION will be returned to its original
berth at Pier 1, Inner Harbor, Baltimore, Maryland. Due to the need to
safeguard dead ship tow participants and prevent vessels or persons
from approaching the USS CONSTELLATION along the intended route
immediately prior to, during, and following the scheduled towing
evolution, vessel traffic will be restricted on certain waters of the
Patapsco River, Northwest Harbor and Inner Harbor.
    The Captain of the Port Baltimore, Maryland is establishing a
temporary moving safety zone around the USS CONSTELLATION dead ship tow
participants from 2 p.m. through 7 p.m. on May 27, 2010, and if
necessary due to inclement weather, from 2 p.m. through 7 p.m. on June
3, 2010. The regulated area includes all waters within 200 yards ahead
of or 100 yards outboard or aft of the historic sloop-of-war USS
CONSTELLATION while operating in the Inner Harbor, the Northwest Harbor
and the Patapsco River. Vessels underway at the time this safety zone
is implemented will immediately proceed out of the zone. With the
exception of USS CONSTELLATION ``turn-around'' participants, entry into
this zone is prohibited unless authorized by the Captain of the Port or
his designated representative. U.S. Coast Guard patrol vessels will be
provided to prevent the movement of persons and vessels in the
regulated area. The Captain of the Port will issue Broadcast Notices to
Mariners to publicize the safety zone and notify the public of changes
in the status of the zone. Such notices will continue until the event
is complete.

Regulatory Analyses

    We developed this rule after considering numerous statutes and
executive orders related to rulemaking. Below we summarize our analyses
based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, and does not
require an assessment of potential costs and benefits under section
6(a)(3) of that Order. The Office of Management and Budget has not
reviewed it under that Order. Although this safety zone restricts
vessel traffic through the affected area, the effect of this regulation
will not be significant due to the limited size and duration that the
regulated area will be in effect. In addition, notifications will be
made to the maritime community via marine information broadcasts so
mariners may adjust their plans accordingly.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this rule would have a significant economic impact
on a substantial number of small entities. The term ``small entities''
comprises small businesses, not-for-profit organizations that are
independently owned and operated and are not dominant in their fields,
and governmental jurisdictions with populations of less than 50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this rule will
not have a significant economic impact on a substantial number of small
entities. This rule may affect the following entities, some of which
might be small entities: The owners or operators of vessels intending
to operate or transit through or within the safety zone during the
enforcement period. The safety zone will not have a significant
economic impact on a substantial number of small entities for the
following reasons. The safety zone is of limited size and duration.
Smaller vessels not constrained by their draft, which are more likely
to be small entities, may transit around the safety zone. Maritime
advisories will be widely available to the maritime community before
the effective period.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

Collection of Information

    This rule calls for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed

this rule under that Order and have determined that it does not have
implications for federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

Taking of Private Property

    This rule will not cause a taking of private property or otherwise
have taking implications under Executive Order 12630, Governmental
Actions and Interference with Constitutionally Protected Property
Rights.

Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it does not have a substantial direct effect on one or more
Indian tribes, on the relationship between the Federal Government and
Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this rule under Executive Order 13211, Actions
Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule is categorically excluded, under figure 2-1, paragraph (34)(g), of
the Instruction. This rule involves establishing a temporary safety
zone.
    An environmental analysis checklist and a categorical exclusion
determination are available in the docket where indicated under
ADDRESSES.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

0
For the reasons discussed in the preamble, the Coast Guard amends 33
CFR part 165 as follows:

PART 165-- REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 3306,
3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5;
Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security
Delegation No. 0170.1.

0
2. Add Sec.  165.T05-0133 to read as follows:

Sec.  165.T05-0133  Safety Zone; Patapsco River, Northwest and Inner
Harbors, Baltimore, MD

    (a) Location. The following area is a safety zone: all waters
within 200 yards ahead of or 100 yards outboard or aft of the historic
Sloop-of-War USS CONSTELLATION while operating in the Inner Harbor, the
Northwest Harbor and the Patapsco River.
    (b) Definitions. As used in this section:
    (1) Captain of the Port Baltimore means the Commander, U.S. Coast
Guard Sector Baltimore, Maryland.
    (2) Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Baltimore to assist in enforcing the safety zone described in
paragraph (a) of this section.
    (3) USS CONSTELLATION ``turn-around'' participants means the USS
CONSTELLATION, its support craft and the accompanying towing vessels.
    (c) Regulations. (1) All persons are required to comply with the
general regulations governing safety zones found in 33 CFR 165.23.
    (2) With the exception of USS CONSTELLATION ``turn-around''
participants, entry into or remaining in this zone is prohibited unless
authorized by the Coast Guard Captain of the Port Baltimore. Vessels
already at berth, mooring, or anchor at the time the security zone is
implemented do not have to depart the safety zone. All vessels underway
within this safety zone at the time it is implemented are to depart the
zone.
    (3) Persons desiring to transit the area of the safety zone must
first request authorization from the Captain of the Port Baltimore or
his designated representative. To seek permission to transit the area,
the Captain of the Port Baltimore and his designated representatives
can be contacted at telephone number<PHONE_NUMBER> or on Marine Band
Radio, VHF-FM channel 16 (156.8 MHz). The Coast Guard vessels enforcing
this section can be contacted on Marine Band Radio, VHF-FM channel 16
(156.8 MHz). Upon being hailed by a U.S. Coast Guard vessel, or other
Federal, State, or local agency vessel, by siren, radio, flashing
lights, or other means, the operator of a vessel shall proceed as
directed. If

permission is granted, all persons and vessels must comply with the
instructions of the Captain of the Port Baltimore or his designated
representative and proceed at the minimum speed necessary to maintain a
safe course while within the zone.
    (4) Enforcement. The U.S. Coast Guard may be assisted in the patrol
and enforcement of the zone by Federal, State, and local agencies.
    (d) Enforcement period. This section will be enforced from 2 p.m.
through 7 p.m. on May 27, 2010, and if necessary due to inclement
weather, from 2 p.m. through 7 p.m. on June 3, 2010.

    Dated: March 25, 2010.
Mark P. O'Malley,
Captain, U.S. Coast Guard, Captain of the Port Baltimore, Maryland.
[FR Doc. 2010-8093 Filed 4-8-10; 8:45 am]
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[Federal Register Volume 85, Number 178 (Monday, September 14, 2020)]
[Notices]
[Page 56603]
[FR Doc No: 2020-19764]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10013-89-OP]

National Environmental Justice Advisory Council; Notice of
Charter Renewal

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of charter renewal.

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SUMMARY: Notice is hereby given that the Environmental Protection
Agency (EPA) has determined that, in accordance with the provisions of
the Federal Advisory Committee Act (FACA), the National Environmental
Justice Advisory Council (NEJAC) is necessary and in the public
interest in connection with the performance of duties imposed on the
agency by law. Accordingly, NEJAC will be renewed for an additional
two-year period. The purpose of the NEJAC is to provide independent
advice and recommendations to the Administrator about issues associated
with integrating environmental justice concerns into EPA's outreach
activities, public policies, science, regulatory, enforcement, and
compliance decisions.

FOR FURTHER INFORMATION CONTACT: Inquiries may be directed to Karen L.
Martin, NEJAC Designated Federal Officer, U.S. EPA, 1200 Pennsylvania
Avenue NW (Mail Code 2202A), Washington, DC 20460; by telephone at 202-
564-0203; via email at<EMAIL_ADDRESS>
Brittany Bolen,
Associate Administrator for the Office of Policy.
[FR Doc. 2020-19764 Filed 9-11-20; 8:45 am]
BILLING CODE 6560-50-P