ICR Supporting Statement
                        Information Collection Request:
                      Cooling Water Intake Structures New
                         Facility Final Rule (Renewal)

                OMB Control No. 2040-0241, EPA ICR No. 1973.06

                                 December 2015

                                 Prepared for
                 United States Environmental Protection Agency
                        Office of Wastewater Management
                         1200 Pennsylvania Avenue, NW
                             Washington, DC 20460

                        EPA Contract Number EP-C-11-009
                        EPA Work Assignment Number 4-22

Contents
ICR Supporting Statement	1
A. Justification	1
1. Explain the circumstances that make the collection necessary and explain the legal or administrative requirements relevant to the collection and attach a copy of the statute or regulation authorizing the collection	1
2. Indicate how, by whom and for what purpose the information is to be used	1
3. Describe whether and to what extent the collection involves the use of automated processes or information technology to aid with the collection	3
4. Describe the efforts to identify duplication	3
5. Explain whether or not the collection impacts small entities	3
6. Describe the consequences to the program if the collection is not conducted or is conducted less frequently	3
7. Explain any special circumstances associated with "extraordinary burden" placed on respondents	4
8. Provide a copy and identify the date and page number of the notice in the Federal Register	4
9. Explain any decision to provide compensation to respondents	5
10. Describe any assurance of confidentiality provided to respondents	5
11. Provide additional justification for any questions of a sensitive nature	5
12. Provide estimates of the hour burden of the collection of information	5
13. Provide an estimate of the total annual cost burden to respondents	6
14. Provide an estimate of the annualized cost to the federal government	6
15. Explain the reasons for an adjustments reported in items 13 or 14 of OMB Form 83-I	6
16. Outline any plans for tabulation and publication of the information	7
17. Explain any requests to not display the expiration date of OMB approval	8
18. Explain any exceptions to the certification statement 5 CFR 1320.9, "Agency Certifications for Proposed Collections of Information."	8
B. Statistical Methods (used for collection of information employing statistical methods)	8
Appendix A  -  Detailed Results of Respondent Burden and Cost Analysis for the Information Collection Requirements of the Section 316(b) New Facility Rule	9
Appendix B  -  Description of the Information Collected and Methodology for Estimating Respondent Burden and Cost of Collection	10
B.1	Estimating Respondent Burden	10
B.2	Estimating Respondent Costs	13
B.2.1	Estimating Labor Costs	13
B.2.2	Estimating Capital and Operation and Maintenance Costs	14
Appendix B  -  References	17
Appendix C  -  Copy of Regulations Authorizing Data Collection and Federal Register Notice	18
C.1 Authorizing Regulations	18
C.2 Federal Register Notice	18

A. Justification
1. Explain the circumstances that make the collection necessary and explain the legal or administrative requirements relevant to the collection and attach a copy of the statute or regulation authorizing the collection
Section 316(b) of the Clean Water Act (CWA) provides that "[a]ny standard established pursuant to [CWA section 301] or [CWA section 306] and applicable to a point source shall require that the location, design, construction, and capacity of cooling water intake structures reflect the best technology available for minimizing adverse environmental impact." The section 316(b) New Facility Rule (66 FR 65256; December 18, 2001) and minor amendments (68 FR 36749; June 19, 2003) implement section 316(b) of the CWA as it applies to new facilities that use cooling water intake structures (CWISs). The rule requires new facilities to submit several distinct types of information as part of their National Pollutant Discharge Elimination System (NPDES) permit application. In addition, the rule requires new facilities to maintain monitoring and reporting data as outlined by the Director in their NPDES permits. The information requirements in this Information Collection Request (ICR) are necessary to ensure that new facilities are complying with the rule's provisions, and thereby minimizing adverse environmental impact resulting from impingement and entrainment losses due to the withdrawal of cooling water.

The first ICR approval period covering years 1 through 3 after promulgation expired in February 2005. The first ICR renewal period covering years 4 through 6 after promulgation expired in June 2008. The second ICR renewal period covering years 7 through 9 after promulgation expired in December 2011. The third ICR renewal period covering years 10 through 12 after promulgation will expire in December 2015. This Supporting Statement is for the fourth renewal ICR, covering years 13 through 15 after promulgation.
2. Indicate how, by whom and for what purpose the information is to be used
This ICR covers information that must be submitted to NPDES permitting authorities (i.e., Directors) and data that must be collected and maintained on-site by new facilities as defined in 40 CFR 125.83. NPDES permits are issued for no more than five years. NPDES application information for new or reissued permit must be submitted in accordance with the timelines outlined in 40 CFR 122.21.

New facilities are required to submit information outlined in 40 CFR 125.86 when applying for their new or reissued NPDES permit. New facilities are also required to maintain their monitoring and reporting data as outlined in their NPDES permit. Each new facility maintains facility-level records of the measurements, diagrams, and calculations submitted to the Director, as well as the analytical results of monitoring activities. There are multiple options for new facilities to submit the information outlined in 40 CFR 125.86. There are no forms for collecting the information. Directors are primarily responsible for determining how new facilities submit the required information.

While respondents for this ICR would include any new facilities that meet the applicable requirements of the rule, EPA estimates that there are six primary industrial sectors that account for more than 99 percent of all cooling water used in the United States: 1) traditional steam electric utilities, 2) nonutility power producers, 3) manufacturers in SIC Major Group 26 (paper and allied products), 4) manufacturers in SIC Major Group 28 (chemicals and allied products), 5) manufacturers in SIC Major Group 29 (petroleum and coal products, and 6) manufacturers in SIC Major Group 33 (primary metals). A detailed description of the SIC (and NAICS) codes can be found at 66 FR 65257.

Information collected will be used by new facilities, Directors, EPA, and other stakeholders. New facilities may use it to monitor their CWIS performance and monitor the performance of design and construction technologies. The primary users of this information will be Directors, states authorized to administer the NPDES permitting program and EPA Regions. Since section 316(b) standards are implemented through NPDES permits, the rule affects Directors in a manner similar to other changes to NPDES program requirements. There are currently 46 States and one territory authorized under CWA Section 402(b) to implement the NPDES permit program. In non-authorized states, EPA assumes the role of the Director.

The Director will use the information to verify that the NPDES permit application is complete, assess whether the compliance alternative selected by the facility is appropriate, and to evaluate monitoring data, annual reports, and other information to confirm that the facility remains in compliance throughout its permit term. The Director may also use the information to develop special permit conditions, such as additional protections for endangered species.

Much of the basic information obtained from a facility's NPDES permit application is stored in EPA's Integrated Compliance Information System (ICIS), the Agency's modernized NPDES program database. ICIS is used to track permit limits, permit expiration dates, monitoring data, and other data, and provide EPA with a nationwide inventory of permit holders. EPA Headquarters uses the information contained in the ICIS database to develop reports on permit issuance, backlog, and compliance rates. The Agency also uses the information to respond to public and Congressional inquiries, develop and guide its policies, formulate its budgets, assist States in acquiring authority for permitting programs, and manage the NPDES program to ensure national consistency in permitting.

It is also anticipated that other government agencies, both at the state and federal level, as well as public interest groups, private companies, and individuals will also use the data. Environmental and citizen groups are expected to use the data collected under the final rule to independently assess impingement and entrainment rates for affected water bodies. In addition, the data will be useful for the scientific community for assessing the impact of CWISs on recreational and commercial fisheries productivity and aquatic ecosystem health.

3. Describe whether and to what extent the collection involves the use of automated processes or information technology to aid with the collection
The Agency does not currently require the use of information technology for collection of information from new facilities. Directors are primarily responsible for determining which collection method and information management strategy is most appropriate.

On July 30, 2013, EPA proposed the Clean Water Act National Pollutant Discharge Elimination System (NPDES) Electronic Reporting Rule, which will require electronic reporting of NPDES information rather than the currently-required paper-based reports. On December 1, 2014, EPA published a Supplemental Notice to the 2013 proposed NPDES Electronic Reporting Rule to provide an opportunity for EPA to receive additional comment regarding issues raised by commenters during the public comment period for the proposed rule and discuss possibilities for how EPA might modify the rule to address issues raised by stakeholders. Once the final rule is issued, implementation is expected to be phased in over a period of several years. EPA does not anticipate that the Electronic Reporting Rule will be finalized and implemented within the three year timeframe of this ICR. However, EPA does anticipate that the implementation of the Electronic Reporting Rule in future years will reduce reporting burdens for all entities involved.

4. Describe the efforts to identify duplication
There is no duplication, as there are no other sources available to collect this information.

5. Explain whether or not the collection impacts small entities
This information collection will not have a significant impact on a substantial number of small entities. The term "new facility" is subject to the rule if it meets the applicability requirements in 40 CFR125.81. The rule's minimum intake flow requirements would exclude most new small entities from the compliance requirements. As a result, the rule is expected to affect only a small absolute number of facilities owned by small entities. In 2001, EPA estimated that over the next 20 years eleven facilities owned by small entities are projected to be subject to the final 316(b) regulation. The exact number of facilities owned by small entities that would be subject to the rule annually is difficult to quantify. If any small entities would be affected, it is estimated one to two new respondents that are small entities will be added for this three year ICR renewal period resulting in an estimated total of nine respondents that are small entities.

6. Describe the consequences to the program if the collection is not conducted or is conducted less frequently
Permitted facilities must reapply for NPDES permits before their existing permits expire, typically once every five years. The CWA prohibits NPDES permits from having terms longer than five years. Less frequent permit applications would not provide the permitting authority with sufficiently current data to establish effective limitations or conditions when reissuing permits and to identify, in a timely manner, adverse environmental impact resulting from the operation of new CWISs. In addition, less frequent collection would also hinder the ability of EPA, States, and facility operators to take advantage of technological improvements in impingement and entrainment technologies as they occur, or to track long-term trends.
The data collection is mandatory and the consequences of not collecting the information would result in a failure of the regulated facilities and/or control authorities to comply with the authorizing NPDES regulations. Failure to comply could result in enforcement actions including civil or criminal penalties.
7. Explain any special circumstances associated with "extraordinary burden" placed on respondents
There are no special circumstances where "extraordinary burden" is placed on respondents. The collection of information is conducted in a manner consistent with the Paperwork Reduction Act guidelines at 5 CFR 1320.5(d)(2). Requests for supplemental information for the purposes of emergency response or enforcement activities are exempt from the Paperwork Reduction Act requirements.

8. Provide a copy and identify the date and page number of the notice in the Federal Register
This renewal ICR was published in the Federal Register on October 5, 2015 (80 FR 60142). The notice included a request for comments on the content and impact of these information collection requirements on the regulated community. EPA did not receive any comments on this ICR.A copy of the Federal Register Notice can be found in Appendix C.

Minimum data collection requirements are mandated and specifically defined by the regulations authorizing collection are not subject to change through consultation. These requirements are often incorporated into the NPDES permit. The Directors of NPDES programs are primarily responsible for determining which collection method and information management strategy is most appropriate. During the initial NPDES permit development and during permit reissuance which occurs every five years a consultation occurs between the Director and permittee. During this consultation, the permittee has the opportunity to request clarification of instructions, recordkeeping, disclosure, or reporting format and to request changes to the data requirements and the frequency of collection and reporting that may be warranted by changing circumstances. Specific changes can then be incorporated in the renewed permit. This consultation occurs on an individual basis with each respondent. The permit renewal five year frequency is mandated by the regulation. However, during the interim period the permittee may consult with the Director if significant changes to circumstances of the permittee occur, and, if warranted, the director may enact modifications to the permit.

Additionally, in 2001 EPA finalized the section 316(b) New Facility Rule after conducting outreach activities and considering comments from the public and the regulated community. (See 66 FR 65256, December 18, 2001.) EPA Headquarters staff responsible for program oversight were contacted to provide revised information and data for this ICR.
9. Explain any decision to provide compensation to respondents
No payments or gifts are provided to respondents.

10. Describe any assurance of confidentiality provided to respondents
Applications for an NPDES permit may contain confidential business information. However, EPA does not consider the specific information being requested by the final rule to be typical of confidential business or personal information. If a respondent does consider this information to be of a confidential nature, the respondent may request that such information be treated as confidential. All confidential data will be handled in accordance with 40 CFR 122.7, 40 CFR part 2, and EPA's Security Manual part III, chapter 9, dated August 9, 1976.

11. Provide additional justification for any questions of a sensitive nature
Questions of a sensitive nature are not found in this information collection.

12. Provide estimates of the hour burden of the collection of information
The annual average reporting and record keeping burden for the collection of information by facilities responding to the section 316(b) New Facility Rule is estimated to be an annual average of 144,570 hours of burden which is equal to 1,475 hours per private respondent when divided among an anticipated annual average of 98 facilities. The Director reporting and record keeping burden for the review, oversight, and administration of the rule is estimated to be an annual average of 7,219 hours which is equal to an average 154 hours per respondent when among an anticipated 47 States. The total annual average burden for respondents and States combined is 151,789 hours. The frequency of responses varies between activities; some activities are conducted weekly, while others are conducted annually. Appendix A provides a more detailed presentation of the calculations for deriving estimated hourly burden and its components. Appendix B provides a description of the information collected and methodology for estimating respondent burden and costs. Table 12.1 summarizes the labor burden and associated costs.

Table 12.1 Summary of Labor Burden and Costs

                          Average Annual Respondents
                     Average Annual Total Burden (hours)
                   Average Annual Total Labor Costs (2014$)
Facilities
                                                                             98
                                                                        144,570
                                                                    $9,183,766
State Directors
                                                                             47
                                                                          7,219
                                                                      $365,966
Totals
                                                                            145
                                                                        151,789
                                                                    $9,549,732

13. Provide an estimate of the total annual cost burden to respondents
The non-labor costs for facilities and Directors are the total annual hours and costs collectively incurred for all activities during the 3-year period covered by this ICR. Table 13.1 provides a summary of the average annual number of respondents, burden hours, and costs. A more detailed summary of the calculations can be found in Appendix A Exhibit A.11 and the methodology used to derive costs can be found in Appendix B.

Table 13.1. Summary of Average Non-labor Costs for Facilities and Directors for the 3-Year Period Covered by this ICR

                          Average Annual Respondents
                     Average Annual Capital Costs (2014$)
                     Average Annual O&M Costs (2014$)
                      Total Average Annual Costs (2014$)
Facilities
                                                                             98
                                                                      $605,827
                                                                    $1,654,813
                                                                    $2,260,640
State Directors
                                                                             47
                                                                            $0
                                                                        $7,088
                                                                        $7,088
Totals
                                                                            145
                                                                      $605,827
                                                                    $1,661,901
                                                                    $2,267,728

14. Provide an estimate of the annualized cost to the federal government
There are 47 States and Territories authorized to administer the NPDES permitting program. For new in-scope facilities applying for permits in the 10 unauthorized States and Territories, EPA will incur the costs and burdens similar to those incurred by States with permitting authority. This analysis, however, assumes that facilities complying with the rule during the ICR period will be in NPDES authorized States.

EPA also periodically reviews NPDES permits as part of ongoing permit program oversight. Based on historical reports submitted for 316(b) demonstrations, EPA assumes that it will take approximately 30 hours to perform a detailed review, make comments, and follow up on comments for the 316(b) portions of a State-issued NPDES permit. Table 14.1 summarizes federal burden and cost estimates. Further detail is provided in Exhibit A.4.

Table 14.1 Summary of Average Annual Respondents, Responses, Burden, and Costs for Federal Agency for the 3-Year Period Covered by this ICR

                        Average Annual Burden (hours)
                      Average Annual Labor Costs (2014$)
                     Average Annual O&M Costs (2014$)
                      Total Average Annual Costs (2014$)
                                                                  Agency Totals
                                      177
                                    $8,143
                                     $312
                                    $8,455

15. Explain the reasons for an adjustments reported in items 13 or 14 of OMB Form 83-I
The respondent average annual burden increased by 13,368 hours which represents a 10% increase. The total average annual number of respondents increased by 17 respondents, a 13% increase. The total average cost burden decreased by 10%. Table 15.1 presents a summary of the adjustments in burden estimates from the previously approved ICR. The net adjustments are due to several changes:

 Addition of the newly built facilities: for this 3-year period, 17 new facilities are anticipated to file initial permit application compared to 21 new facilities in the previous ICR, resulting in a reduction in burden. Differences in activities related to these initial permit applications result in a reduction of 7,561 hours for facilities and a reduction of 854 hours for Directors over the previous ICR estimate for this component. The reduction in newly built facilities resulted in a reduction in the cost estimate.
 Continued performance of annual activities by facilities that received their permit during previous ICR periods: As facilities are constructed and permitted, these facilities add to the universe of respondents that are required to perform annual activities under the New Facility Rule. Activities related to these recurring activities account for an increase of 19,420 hours for facilities and 933 hours for Directors over the previous ICR estimate.
 Re-permitting burdens: more facilities are entering the renewal phase of their permits (i.e., 5 years after the last permit was issued). Activities related to these re-permitting activities account for 1,522 hours for facilities over the previous ICR estimate.

Table 15.1 Summary of Adjustments in Burden Estimate
Providers of Information
Reason
Previous Burden
New Burden
Difference
Percent Difference
Type of Change
Facilities
Change in the number of respondents
138,421 hours
151,789 hours
13,368 hours
10%
R
Facilities
Change in the number of respondents
128
145
17
13%
R
Facilities
Change in the number of new respondents
$2,520,668
$2,267,728
-$252,940
-10%
R

PC = Program Change
R = Revised Estimate

16. Outline any plans for tabulation and publication of the information
EPA maintains the compliance data in ICIS, the national computerized management information system that automates entry, updates, and facilitates retrieval of NPDES data and tracks permit issuance, permit limits and monitoring data, and other data pertaining to facilities regulated under NPDES. Permit data can be accessed by the public in one of two ways:

 via the Freedom of Information Act (FOIA) by submitting a request to EPA or the State; or
 via an on-line query using EPA's Envirofacts Data Warehouse and Applications website at http://www.epa.gov/enviro/index.html. Accessing data via Envirofacts provides a method to combine ICIS data with other EPA databases and mapping tools.
17. Explain any requests to not display the expiration date of OMB approval
EPA has not made a request regarding display of the expiration date.

18. Explain any exceptions to the certification statement 5 CFR 1320.9, "Agency Certifications for Proposed Collections of Information."
The agency is able to certify compliance with all provisions under Item 19 of OMB Form 83-I.

B. Statistical Methods (used for collection of information employing statistical methods)
Statistical methods are not used with this collection.

Appendix A  -  Detailed Results of Respondent Burden and Cost Analysis for the Information Collection Requirements of the Section 316(b) New Facility Rule
 (See attached PDF document)

Appendix B  -  Description of the Information Collected and Methodology for Estimating Respondent Burden and Cost of Collection
The following sections present rationale and results of EPA's estimation of burden and costs for the implementation of the section 316(b) New Facility Rule. The burden hours and cost in this section are calculated by first estimating the annual burden, labor cost, and other direct cost (ODC) per facility or Director for each activity. (See Tables B-1 through B-4.) The number of facilities or Directors required to conduct each of the activities per year are then estimated and used to calculate the yearly burden hours and costs. Not all facilities are required to conduct all the activities, and not all activities occur during all years of the ICR. The total yearly burden hours and costs are then summed and averaged to compute the bottom line average annual burden hours and costs. See Appendix A.
B.1	Estimating Respondent Burden
This section describes the burden estimates for facilities and Directors, as well as the methods used to derive them. Respondent activities are separated into those activities associated with the NPDES permit application and those activities associated with monitoring and reporting after the permit is issued. The reason for this is that the permit cycle is every five years while ICRs must be renewed every three years. Therefore, the application activities occur only once per facility during an ICR period, and so they are considered one-time burden for the purpose of this ICR. By contrast, the monitoring and reporting activities that occur after issuance of the permit occur on an annual basis.

Facility Burdens
Information collection would require in-scope facilities to devote time (i.e., as measured by staff hours) and resources (e.g., copies of documents and report mailings) to produce the necessary NPDES permit applications, implementation plans, and annual status reports. EPA expects that facility employees, including managers, engineers, engineering technicians, statisticians, draftsmen, and clerical staff, will devote time toward gathering, preparing, and submitting the various documents. To develop representative profiles of each employee's relative contribution, EPA assumed burden estimates that reflect the staffing and expertise typically found in manufacturing facilities and power generating plants. In doing this, EPA considered the time and qualifications necessary to complete a variety of tasks: reviewing instructions, planning responses, researching data sources, gathering and analyzing data, typing or writing the information requested, reviewing results, conferring with permitting authorities and expert consultants, and sending documents.

EPA anticipates that facilities will use the contracted services to perform many of their required sampling and analysis tasks. The contracted staff is likely to include project managers, biologists, statisticians, and biological technicians. The work done by these contracted employees will be done on-site on a regular basis. Therefore, the hourly burdens associated with their work are included in the overall burden estimates for each facility.

For each activity burden assumption, EPA selected time estimates to reflect the expected effort necessary to carry out these activities under normal conditions and reasonable labor efficiency rates. EPA assumed that the majority of the actual work performed by facility staff, such as researching, collecting, and analyzing data, as well as writing the documents, will be carried out by junior technical staff. Burdens associated with managerial and senior engineering staff include time for actions such as occasional or seasonal visits to supervise sampling efforts, as well as periodic review of lab results and documentation. EPA assumed that the facilities will employ a drafter to perform computer aided drafting (CAD) operations. For contracted employees, EPA assumes that the majority of the work will be carried out by the biologists and the biological technicians.

Tables B-1 and B-2 provide a summary of the hourly burden estimates for facilities performing the NPDES permit application, annual monitoring, and annual reporting activities associated with the final rule. For a more detailed presentation of hourly burdens for facilities, see Exhibits A.1 and A.2 in Appendix A.

The activities listed in the first column of both Tables B-1 and B-2 correspond to the facility respondent activities. Start-up burden includes reading the published regulations, sample permits, and any guidance materials associated with the rule; determining the required staff and resources necessary to successfully complete the application process and meet all annual monitoring and reporting requirements; and training staff to perform tasks that they would not be required to conduct if the rule were not implemented. General information activities refer to the development and submittal of documentation on source waterbody characteristics and CWIS location and design.

As part of the permit application process, facilities will demonstrate compliance with the proportional flow (i.e., intake flow may not exceed a certain proportion of source water body flow) requirements. Facilities will also collect Source Water Baseline Biological Characterization Data to evaluate the condition of the biological community prior to operation of the new facility and prior to each permit renewal application. The level of effort needed for the study may vary considerably from one facility to another, depending on the availability of existing background information and the characteristics of the waterbody that the CWIS will be located in. For the purpose of developing the ICR cost and burden estimates, it is assumed that there is sufficient existing data for facilities to develop a baseline characterization of the contributing waterbody's biological community.

If a facility chooses Track I for meeting its permit obligations, the facility also needs to comply with flow reduction, velocity and technology requirements. Under the final rule, new facilities choosing Track I must provide information to the permitting authority demonstrating that they are in compliance with the flow reduction, velocity and technology requirements that are applicable to their CWISs. The facility hourly burdens for demonstrating compliance with these requirements include developing and submitting narrative descriptions, supporting documentation, and engineering calculations. Facility burden for Design and Construction Technology Plans is comparable to the burden for demonstrating compliance with one of the CWIS requirements.

Under Track II, the Comprehensive Demonstration Study evaluates the condition of the biological community prior to operation of the new facility and prior to each permit renewal application. The study entails plan development, a source water biological study, projections of anticipated impacts, and verification monitoring. As with the source water baseline biological characterization, the required effort level for the Track II source water biological study is likely to vary considerably depending on the availability of existing data and the complexity of the habitat that the CWIS will be located in.

For the purpose of developing the ICR cost and burden estimates, it is assumed that each Track II facility will perform sampling to develop the Source Water Biological Study for the Comprehensive Demonstration Study. The sampling required for the study is expected to take two years for facilities with intakes drawing from freshwater sources, and three years for facilities drawing from marine sources. Therefore, the entire application process can take up to three years to complete. EPA assumes that start-up activities and general information activities are accomplished during the first year of the permitting process. The Source Water Biological Study activities will be performed over the three years prior to the issuance of the NPDES permit to Track II facilities. The study to evaluate CWIS impacts will be conducted the year just prior to operation of the CWIS to allow the facility time to incorporate information from the Source Water Biological Study already underway. For those Track II facilities beginning operation during the first year of the ICR period, EPA assumes that they do not actually begin operating the CWIS until the end of the year, allowing them enough time to conduct the pilot study.

EPA anticipates that start-up, general information, and the Track I activities will be performed by facility staff. For those facilities taking Track II, EPA assumes that the sampling and statistical analyses will be conducted by contracted employees, although some of the taxonomic identification, enumeration, and characterization will be performed by a sub-contracted laboratory.

After both Track I and II facilities receive their NPDES permits and commence operations, they have annual monitoring and reporting requirements as well. Velocity monitoring and the inspection of installed technology will be carried out by facility staff. For impingement and entrainment monitoring, EPA assumes that the actual monitoring will be conducted by the contracted employees, while the facility manager and junior technical staff will spend some time reviewing the results in preparation for the yearly status report.

In the first year of permitted operation, Track II facilities are required to use impingement and entrainment monitoring data to perform a verification study, confirming that the CWIS technology is achieving impingement and entrainment rates commensurate to that obtained through closed-cycle recirculation technology. EPA assumes that each year approximately 25% of the Verification Studies will show that the facilities have not achieved the required impingement and entrainment level that they predicted in their Comprehensive Demonstration Studies. As a result, EPA assumes that these facilities will take measures to improve their impingement and entrainment rates and submit another Verification Study the following year.

EPA assumes that for Track I facilities, all of the activities performed during the initial permitting process would be repeated for the permit renewal. Track II facilities will need to revise their Comprehensive Demonstration Study and repeat the Source Water Baseline Characterization Study. They do not have to perform another Evaluation of Cooling Water Intake Structure Effects or Verification Monitoring Plan. EPA anticipates that the level of effort required to repeat many of these tasks will be considerably less than what was initially required. Facilities will be able to rely on much of the information gathered during the first permitting process. As a result, the hourly burden estimates for activities are assumed to be 50% to 70 % less than those for the initial permitting process.

Table B-3 provides a summary of the hourly burden estimates for facilities performing the NPDES permit renewal activities associated with the rule. For a more detailed presentation of hourly burdens for facilities see Exhibit A.12 in Appendix A.

Director Burdens
Each Director's actual burden associated with reviewing submitted materials, writing permits, and tracking compliance will depend on the number of new in-scope facilities that will be built in the Director's State during the ICR period. EPA expects that State senior technical, junior technical, and clerical staff will devote time toward gathering, preparing, and submitting the various documents. EPA assumed burden estimates that reflect the staffing and expertise used by States for the NPDES permit administration process. In doing this, EPA considered the time and qualifications necessary to complete various tasks such as: reviewing submitted documents and supporting materials, verifying data sources, planning responses, determining specific permit requirements, writing the actual permit, conferring with facilities and the interested public, and entering the permit information into the ICIS databases. Table B-4 provides a summary of the hourly burden estimates for Directors performing various activities associated with the final rule. EPA assumes that the directors will spend a significant amount of time reviewing the Source Water Biological Characterization Data. The additional effort devoted to reviewing the study is due to the fact that the studies cover three years of data collected at the site. For a more detailed presentation of Director hourly burdens see Exhibits A.3 and A.13 in Appendix A.

B.2	Estimating Respondent Costs
This section describes the cost estimates for facilities and Directors, as well as the methods used to derive them.

B.2.1	Estimating Labor Costs
The costs to the respondent facilities associated with these time commitments can be estimated by multiplying the time spent in each labor category by an appropriately loaded hourly wage rate. All base wage rates used for facility labor categories were derived from the Bureau of Labor Statistics' (BLS) Occupational Employment and Wages, 2013. These reported labor rates were based upon data from May 2013, and were adjusted for inflation to September 2014. Inflation factors ranging from 2.4% to 3.3%, depending on the labor category, were derived from the BLS Employment Cost Index for adjusting the Occupational Employment and Wages, 2013 labor rates to reflect labor rates as of September of 2014. Compensatory loading factors ranging from 43% to 68%, depending on the labor category, were used to account for any paid leave, supplemental pay, insurance, retirement and savings, and required and non-required benefits received by employees. EPA assumed an additional loading factor of 15% to account for general overhead costs directly attributable to facility employees performing work in support of the permit process. Expenses for contracted employees, typically include higher overhead costs, as well as fees to ensure profit for the contracting company. EPA assumes that the overhead for the contracted employees will be 50% and the fee will be 8%.

To represent the base labor rate for facility management, EPA used the median engineering manager category for management occupations of $61.62 per hour. After adjusting this rate for inflation, compensation, and overhead the rate is $109.80 per hour. The median wage of $25.19 per hour for an engineering technician was used to represent the base labor rate junior technical staff. After adjusting for inflation and other factors this labor rate was $44.90 per hour. The median annual salary for a drafter performing CAD work was reported to be $23.46 per hour, and after adjusting and loading the rate it is $41.80. The reported median wage for clerical workers was $14.45 per hour and the fully adjusted and loaded hourly rate is $26.70 per hour.

The base labor rate for a contracted manager for monitoring work conducted on-site is assumed to be for the median natural science manager in management occupations, with a fully loaded rate of $134.40 per hour. The median wage for a statistician was $38.12 per hour, with an adjusted hourly rate of $90.40 per hour. Biologists and biological technicians have an average hourly pay of $29.26 and $20.05, and a fully loaded rate of $69.40 and $47.60, respectively.

Director Labor Costs
To calculate the Director's costs, all of the base labor rates and compensation factors were derived from published employment cost trends for State and local government workers for the second quarter of 2013. These labor rates were adjusted to reflect labor rates for September 2014. EPA chose the BLS labor category of white-collar General Operations Manager to represent the senior administrative and technical staff that will oversee and manage the NPDES permit program. The base hourly rate for this category was approximately $42.14 per hour, and after adjusting for compensation and inflation it is $74.70 per hour. Similarly, EPA chose the BLS labor category of mechanical engineering technician to represent the junior technical staff that EPA expects to perform the majority of the actual NPDES permitting work. The reported base pay for this category was approximately $19.72 per hour, which becomes $34.70 per hour after being adjusted for compensation, overhead, and inflation. The hourly wage for State government clerical workers was $14.50 per hour before adjustment, and $28.90 afterward.
B.2.2	Estimating Capital and Operation and Maintenance Costs
Facility O&M Costs
A facility incurs capital/start-up costs when it purchases equipment or builds structures that are needed for compliance with the rule's reporting and record keeping requirements that the facility will not use otherwise. EPA assumed that some facilities would incur capital/startup costs as a result of this rule.

A facility incurs operation and maintenance (O&M) costs when it uses services, materials, or supplies needed to comply with the rule's reporting and record keeping requirements that the facility will not use otherwise. Any cost for the operation and upkeep of capital equipment is considered O&M costs. Another type of O&M cost is for the purchase of contracted services such as laboratory analyses. The purchase of supplies such as filing cabinets and services such as photocopying or boat rental, are also considered O&M costs, and are referred to as ODCs.

EPA assumes that samples taken for the Source Water Baseline Biological Characterization Study will be analyzed by a contracted laboratory. The outside laboratories will perform taxonomic classification, data tabulation, and then deliver the data back to the facility. For the two to three years of monitoring required by the Source Water Baseline Biological Characterization Study, this service is estimated to cost $89,600 for facilities located adjacent to freshwater waterbodies and $174,800 for facilities drawing from either estuaries, oceans, or the Great Lakes.

For the evaluation of CWIS effects, EPA anticipates that facilities will perform pilot studies to determine the effectiveness of the technology they will be using to minimize impingement and entrainment. EPA assumes that the facility will be willing to spend approximately 10% of the anticipated costs of installing and operating the proposed technology. For costing purposes, EPA is assuming that a pilot study will be performed using a Gunderboom system. The range of costs for a floating Gunderboom system for a 150 MGD intake structure is $1.8 to $2.5 million in capital costs, and $150,000 to $300,000 in annual O&M costs (Phase I Technical Development Document). Using 10% of the high end of this range, and adjusting for inflation to September 2014, EPA estimates the Track II facility spends $303,000 to purchase and install a pilot Gunderboom system, and $34,500 to operate and maintain it for the study. Gunderboom technology was selected as an example technology that is potentially capable of meeting Track II requirements at a facility using a once-through cooling system. EPA assumes the pilot study impingement samples will be analyzed on-site by the biologists due to the difficulty of preserving impingement samples for shipment to an outside laboratory. Entrainment analysis of pilot study monitoring samples will be performed by an outside laboratory, at a cost of $6,900 for facilities drawing from freshwater, and $9,000 for facilities drawing from estuaries and the Great Lakes.

For visual inspections, EPA assumes that the Track I facilities will employ remote monitoring devices to monitor the equipment performance. The cost for the remote monitoring device includes $33,250 (Haught and Panguluri 1998) for purchase of equipment and $16,750 for installation and testing of equipment, for an adjusted total of $62,000.

For annual O&M costs, EPA assumes again that the analysis of impingement monitoring samples will be done on-site, while entrainment monitoring samples will be performed by an outside laboratory. Entrainment samples are estimated to cost $9,000 per year for freshwater facilities, and an estimated $11,700 per year for facilities drawing from estuaries or the Great Lakes.

In general, the labor costs and O&M costs reported in this analysis are assumed to represent typical average national cost estimates that are likely to be incurred by new facilities and by permitting authorities. EPA attempted to take into account various factors such as decreases in labor efficiency that occur during extreme climate conditions, equipment down time, and the occasional sample that might need to be replaced because it was lost or spoiled during transport. The Tables B-1 and B-2 provide a summary of both the estimated labor costs and ODCs per facility. For a more detailed presentation of all compliance costs for facilities see Exhibits A.1 and A.2 in Appendix A.

Table B-1. Burden and Costs per Facility for NPDES Permit Application Activities
                                  Activities
                                 Burden (hrs)
                                Labor Cost ($)
                                    ODC ($)
Start-up Activities
                                                                             43
                                                                        $3,044
                                                                           $55
General Information Activities
                                                                            146
                                                                        $7,744
                                                                          $575
CWIS Flow Requirement
                                                                            104
                                                                        $4,752
                                                                          $115
Source Water Baseline Biological Characterization
                                                                            265
                                                                       $16,163
                                                                          $860
CWIS Velocity Requirement (Track I)
                                                                            138
                                                                        $7,706
                                                                        $1,150
CWIS Flow Reduction Requirement (Track I)
                                                                            108
                                                                        $5,357
                                                                          $460
Design and Construction Technology Plan (Track I)
                                                                            108
                                                                        $6,229
                                                                           $55
Comprehensive Study Plan (Track II)
                                                                            271
                                                                       $17,446
                                                                          $860
Source Water Biological Characterization-Freshwater (Track II)*
                                                                          5,196
                                                                      $326,127
                                                                        $6,000
Source Water Biological Characterization-Estuary & Great Lake (Track II)*
                                                                          9,368
                                                                      $573,308
                                                                       $14,900
Evaluation of Potential CWIS Effects - Freshwater (Track II)*
                                                                          1,626
                                                                      $113,215
                                                                        $1,100
Evaluation of Potential CWIS Effects - Estuary & Great Lake (Track II)*
                                                                          1,950
                                                                      $132,120
                                                                        $1,100
Verification Monitoring Plan
                                                                            128
                                                                        $8,433
                                                                          $460
*This activity also has contracted service costs associated with it

Table B-2. Burden and Costs per Facility for Annual Monitoring and Reporting Activities
                                  Activities
                                 Burden (hrs)
                                Labor Cost ($)
                                    ODC ($)
Verification Monitoring- Freshwater (Track II)
                                                                             92
                                                                        $7,380
                                                                          $575
Verification Monitoring- Estuary (Track II)
                                                                            122
                                                                        $9,849
                                                                          $575
Initial Biological Monitoring (impingement) Freshwater
                                                                            379
                                                                       $24,802
                                                                          $575
Reduced Biological Monitoring (impingement) Freshwater
                                                                            191
                                                                        12535.9
                                                                          287.5
Initial Biological Monitoring (entrainment)Freshwater*
                                                                            482
                                                                       $31,520
                                                                          $745
Reduced Biological Monitoring (entrainment)Freshwater*
                                                                            244
                                                                       $16,035
                                                                           $373
Initial Biological Monitoring (impingement) Estuary
                                                                            614
                                                                       $40,766
                                                                         $1,150
Reduced Biological Monitoring (impingement) Estuary
                                                                            308
                                                                       $20,473
                                                                           $575
Initial Biological Monitoring (entrainment) Estuary*
                                                                            776
                                                                       $50,903
                                                                         $1,320
Reduced Biological Monitoring (entrainment) Estuary*
                                                                            392
                                                                       $25,749
                                                                           $660
Velocity Monitoring
                                                                            163
                                                                        $7,627
                                                                          $115
Visual Inspection of CWIS Technology
                                                                            253
                                                                       $13,076
                                                                          $115
Yearly Status Report Activities
                                                                            348
                                                                       $25,563
                                                                          $860
*This activity also has contracted service costs associated with it.

Table B-3. Burden and Costs per Facility for NPDES Permit Renewal Activities
                                  Activities
                                 Burden (hrs)
                                Labor Cost ($)
                                    ODC ($)
Start-up Activities
                                                                             13
                                                                           $973
                                                                            $55
General Information Activities
                                                                             72
                                                                         $4,087
                                                                           $575
CWIS Flow Requirement
                                                                             31
                                                                         $1,394
                                                                           $115
Source Water Baseline Biological Characterization
                                                                             79
                                                                         $4,894
                                                                           $860
CWIS Velocity Requirement (Track I)
                                                                             75
                                                                         $4,123
                                                                         $1,150
CWIS Flow Reduction Requirement (Track I)
                                                                            108
                                                                         $5,357
                                                                           $460
Design and Construction Technology Plan (Track I)
                                                                             43
                                                                         $2,464
                                                                            $55
Comprehensive Study Plan (Track II)
                                                                             80
                                                                         $5,088
                                                                           $860
Source Water Biological Characterization - Freshwater (Track II)*
                                                                          2,808
                                                                       $171,092
                                                                         $3,600
Source Water Biological Characterization - Estuary & Great Lake (Track II)*
                                                                          5,268
                                                                       $315,934
                                                                         $9,000
*This activity also has contracted service costs associated with it.

Director O&M Costs
EPA does not anticipate any operation and maintenance costs for Directors under this rule. Table B-4 provides estimates of Director ODCs and labor costs. For a more detailed explanation of Director costs see Exhibit A.3.

Table B-4. Estimating Director Burden and Costs for Activities
                                  Activities
                                 Burden (hrs)
                                Labor Cost ($)
                                    ODC ($)
Director Permit Issuance Activities for Track I Facility
                                                                            188
                                                                         $9,866
                                                                           $345
Director Permit Issuance Activities for Track II Facility
                                                                            646
                                                                        $41,679
                                                                           $345
Verification Study Review (per Facility)
                                                                             21
                                                                           $963
                                                                            $55
Annual Director Activities (per Facility)
                                                                             50
                                                                         $2,329
                                                                            $55
Director Repermitting Activities for Track I Facility
                                                                             55
                                                                         $2,960
                                                                           $345
Director Repermitting Activities for Track II Facility
                                                                            143
                                                                         $8,991
                                                                           $345

Appendix B  -  References
Haught, R., and S. Panguluri, 1998. Selection and management of remote telemetry systems for monitoring and operation of small drinking water treatment plants. In proceedings of the First International Symposium on Safe Drinking Water in Small Systems, Washington, DC.

Appendix C  -  Copy of Regulations Authorizing Data Collection and Federal Register Notice
C.1 Authorizing Regulations
(See attached PDF document)
C.2 Federal Register Notice
(See attached PDF document)


[Federal Register: December 29, 2008 (Volume 73, Number 249)]
[Notices]
[Page 79533-79535]
[DOCID:fr29de08-105]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59112; File No. SR-NYSE-2008-125]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by New York Stock Exchange LLC
That the $8,000,000 Annual Trading Floor Regulatory Fee Allocated Among
the Designated Market Maker Firms, Formerly Referred to as the
``Specialist Trading Floor Regulatory Fee,'' Be Reduced by 50% for
2008, and Eliminated Thereafter

December 17, 2008.
    Pursuant to Section 19(b)(1) \1\ of the Securities Exchange Act of
1934 (the ``Act'') \2\ and Rule 19b-4 thereunder,\3\ notice is hereby
given that, on December 15, 2008, New York Stock Exchange LLC (``NYSE''
or the ``Exchange'') filed with the Securities and Exchange Commission
(the ``Commission'') the proposed rule change as described in Items I
and II below, which Items have been prepared by the self-regulatory
organization. The Commission is publishing this notice to solicit
comments on the proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78a.
    \3\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes that the $8,000,000 annual trading floor
regulatory fee allocated among the Designated Market Maker firms
(``DMMs'' or ``firms''),\4\ formerly referred to as the ``specialist
trading floor regulatory fee,'' be reduced by 50% for 2008, and
eliminated thereafter.
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 58845 (October 24,
2008) 73 FR 64379 (October 29, 2008) (SR-NYSE-2008-46). In this rule
filing, which created a new market model for the Exchange, the role
of the specialist was altered in certain respects and the term
``specialist'' was replaced with the term ``Designated Market Maker
(`DMM').'' Therefore, the annual trading floor regulatory fee
previously paid by ``specialist'' firms will be referred to as the
``Designated Market Maker'' annual trading floor regulatory fee.
---------------------------------------------------------------------------

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the self-regulatory organization
included statements concerning the purpose of, and basis for, the
proposed rule change and discussed any comments it received on the
proposed rule change. The text of those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Effective retroactively to July 1, 2008, the Exchange proposes that
the $8,000,000 annual trading floor regulatory fee allocated among the
DMMs be reduced by 50% for 2008 (i.e., $4,000,000), and eliminated
thereafter. The purpose of the trading floor regulatory fee has been to
defray the costs incurred by the Exchange in connection with the
monitoring of trading floor activity by the Exchange's Market
Surveillance Division. Effective January 1, 2008, the Exchange reduced
this fee from $16,000,000 to $8,000,000.

At that time the Exchange noted that the dramatically increased
percentage of NYSE trades automatically executed and the shifts in the
specialists' trading role under the Hybrid Market initiative made it
appropriate to reduce the direct annual contribution to the regulatory
program. After further study this year, and in light of the launching
of the New Market Model,\5\ which was filed with the Commission for
immediate effectiveness [sic] on October 24, 2008, the Exchange has
determined that it is appropriate to eliminate this fee entirely. As a
result, it is proposed that from July 1, 2008 to the end of 2008, this
annual fee be reduced from $8,000,000 to $4,000,000 (the amount already
billed at the time this approach was discussed with the members) and
that the fee be eliminated hereafter for all members.
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 58845 (October 24,
2008) 73 FR 64379 (October 29, 2008) (SR-NYSE-2008-46).
---------------------------------------------------------------------------

Background
    In the past, what was formerly referred to as the ``specialists'
annual trading floor regulatory fee'' and now referred to as the
``Designated Market Maker annual trading floor regulatory fee,'' was
billed to each firm in four quarterly installments. For the reasons
stated above, in June 2008 the Exchange decided to reduce the fee from
$8,000,000 to $4,000,000 (i.e., the amount that had already been billed
to each firm by July 1, 2008), and to completely eliminate the fee in
anticipation of the launching of the New Market Model in the fall of
2008.
    In or about June and July 2008, the Exchange informed each firm
that they should not pay the third or fourth quarter installments of
the annual trading floor regulatory fee as such reduced fee of
$4,000,000 had been satisfied by the installments in the first two
quarters of the year ($2,000,000 x 2 = $4,000,000). By July 1, 2008,
each firm had paid the full amount of the reduced regulatory fee. The
Exchange instructed the firms to disregard any future bills for this
fee, and in the event the firms had already paid the third quarter
installment of the fee, the Exchange would give the firms a credit for
any payment over $4,000,000. The Exchange applied this reduced annual
trading floor regulatory fee of $4,000,000 to all DMM firms (formerly
specialist firms). The fee will be eliminated henceforth, and will not
appear on the 2009 NYSE Price List.
    The elimination of the annual trading floor regulatory fee will not
have any impact on the Exchange's ability to maintain its current level
of trading floor surveillance or to develop and adopt new surveillance
technologies and procedures in the future.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 \6\ of the Securities Exchange Act of
1934 (the ``Act'') \7\ in general and Section 6(b)(4) of the Act \8\ in
particular, in that it is designed to provide for the equitable
allocation of reasonable dues, fees and other charges among its members
and other persons using its facilities.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78f.
    \7\ 15 U.S.C. 78a.
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing rule does not (i) Significantly affect the
protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days from the date on which it was filed, or such shorter time as the
Commission may designate if consistent with the protection of investors
and the public interest, provided that the self-regulatory organization
has given the Commission written notice of its intent to file the
proposed rule change at least five business days prior to the date of
filing of the proposed rule change or such shorter time as designated
by the Commission, the proposed rule change has become effective
pursuant to Section 19(b)(3)(A) of the Act \9\ and Rule 19b-4(f)(6)
thereunder.\10\ At any time within 60 days of the filing of such
proposed rule change, the Commission may summarily abrogate such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSE-2008-125 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.

All submissions should refer to File Number SR-NYSE-2008-125. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/
sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room, 100 F Street, NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of the filing will also be available for
inspection and copying at the principal office of the self-regulatory
organization. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File Number SR-
NYSE-2008-125 and should be submitted on or before January 20, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-30787 Filed 12-24-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 12 (Friday, January 17, 2014)]
[Notices]
[Pages 3215-3217]
[FR Doc No: 2014-00900]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2013-0951]

Information Collection Request to Office of Management and Budget

AGENCY: Coast Guard, DHS.

ACTION: Sixty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995, the
U.S. Coast Guard intends to submit an Information Collection Request
(ICRs) to the Office of Management and Budget (OMB), Office of
Information and Regulatory Affairs (OIRA), requesting approval of a
revision to the following collection of information: 1625-0008,
Regattas and Marine Parades. Our ICR describes the information we seek
to collect from the public. Before submitting this ICR to OIRA, the
Coast Guard is inviting comments as described below.

DATES: Comments must reach the Coast Guard on or before March 18, 2014.

ADDRESSES: You may submit comments identified by Coast Guard docket

number [USCG-2013-0951] to the Docket Management Facility (DMF) at the
U.S. Department of Transportation (DOT). To avoid duplicate
submissions, please use only one of the following means:
    (1) Online: http://www.regulations.gov.
    (2) Mail: DMF (M-30), DOT, West Building Ground Floor, Room W12-
140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
    (3) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    (4) Fax:<PHONE_NUMBER>. To ensure your comments are received in a
timely manner, mark the fax, to attention Desk Officer for the Coast
Guard.
    The DMF maintains the public docket for this Notice. Comments and
material received from the public, as well as documents mentioned in
this Notice as being available in the docket, will become part of the
docket and will be available for inspection or copying at room W12-140
on the West Building Ground Floor, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. You may also find the docket on the Internet
at http://www.regulations.gov.
    Copies of the ICRs are available through the docket on the Internet
at http://www.regulations.gov. Additionally, copies are available from:
COMMANDANT (CG-612), ATTN PAPERWORK REDUCTION ACT MANAGER, US COAST
GUARD, 2703 MARTIN LUTHER KING JR AVE SE STOP 7710, WASHINGTON DC
20593-7710.

FOR FURTHER INFORMATION CONTACT: Contact Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents. Contact Ms. Barbara Hairston, Program
Manager, Docket Operations,<PHONE_NUMBER>, for questions on the docket.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collections. There is
one ICR for each Collection.
    The Coast Guard invites comments on whether these ICRs should be
granted based on the Collections being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collections; (2) the accuracy of the estimated burden of the
Collections; (3) ways to enhance the quality, utility, and clarity of
information subject to the Collections; and (4) ways to minimize the
burden of the Collections on respondents, including the use of
automated collection techniques or other forms of information
technology. In response to your comments, we may revise these ICRs or
decide not to seek approval of revisions of the Collections. We will
consider all comments and material received during the comment period.
    We encourage you to respond to this request by submitting comments
and related materials. Comments must contain the OMB Control Number of
the ICR and the docket number of this request, [USCG-2013-0951], and
must be received by March 18, 2014. We will post all comments received,
without change, to http://www.regulations.gov. They will include any
personal information you provide. We have an agreement with DOT to use
their DMF. Please see the ``Privacy Act'' paragraph below.

Submitting Comments

    If you submit a comment, please include the docket number [USCG-
2013-0951], indicate the specific section of the document to which each
comment applies, providing a reason for each comment. You may submit
your comments and material online (via http://www.regulations.gov), by
fax, mail, or hand delivery, but please use only one of these means. If
you submit a comment online via www.regulations.gov, it will be
considered received by the Coast Guard when you successfully transmit
the comment. If you fax, hand deliver, or mail your comment, it will be
considered as having been received by the Coast Guard when it is
received at the DMF. We recommend you include your name, mailing
address, an email address, or other contact information in the body of
your document so that we can contact you if we have questions regarding
your submission.
    You may submit your comments and material by electronic means,
mail, fax, or delivery to the DMF at the address under ADDRESSES; but
please submit them by only one means. To submit your comment online, go
to http://www.regulations.gov, and type ``USCG-2013-0951'' in the
``Keyword'' box. If you submit your comments by mail or hand delivery,
submit them in an unbound format, no larger than 8\1/2\ by 11 inches,
suitable for copying and electronic filing. If you submit comments by
mail and would like to know that they reached the Facility, please
enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and will address them accordingly.
    Viewing comments and documents: To view comments, as well as
documents mentioned in this Notice as being available in the docket, go
to http://www.regulations.gov, click on the ``read comments'' box,
which will then become highlighted in blue. In the ``Keyword'' box
insert ``USCG-2013-0951'' and click ``Search.'' Click the ``Open Docket
Folder'' in the ``Actions'' column. You may also visit the DMF in Room
W12-140 on the ground floor of the DOT West Building, 1200 New Jersey
Avenue SE., Washington, DC 20590, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.

Privacy Act

    Anyone can search the electronic form of comments received in
dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act statement
regarding Coast Guard public dockets in the January 17, 2008, issue of
the Federal Register (73 FR 3316).

Information Collection Request

    1. Title: Regattas and Marine Parades.
    OMB Control Number: 1625-0008.
    Summary: 46 U.S.C. 1233 authorizes the Coast Guard to issue rules
to promote the safety of life on navigable waters during regattas and
marine parades. 33 CFR 100.17 and 100.18 promulgate the rules for
providing notice of, and additional information for permitting regattas
and marine parades (marine events) to the Coast Guard.
    Need: The Coast Guard needs to determine whether a marine event may
present a substantial threat to the safety of human life on navigable
waters and determine which measures are necessary to ensure the safety
of life during the events. Sponsors must notify the Coast Guard of the
efficient means for the Coast Guard to learn of the events and address
environmental impacts.

    Forms: CG-4423.
    Respondents: Sponsors of marine events.
    Frequency: On occasion.
    Burden Estimate: The estimated burden of 5,500 hours a year remains
the same.

    Dated: January 8, 2014.
R.E. Day,
Rear Admiral, U.S. Coast Guard, Assistant Commandant for Command,
Control, Communications, Computers and Information Technology.
[FR Doc. 2014-00900 Filed 1-16-14; 8:45 am]
BILLING CODE 9110-04-P


Appendix A

Safety Inspection and Education Act (820 ILCS 220)

Health and Safety Act (820 ILCS 225)

Toxic Substances Disclosure to Employees Act (820 ILCS 255)

Department of Labor Adopted Rules (56 Ill. Adm. Code Part 350)

Letter of Support from former Governor Blagojevich


[Federal Register Volume 81, Number 221 (Wednesday, November 16, 2016)]
[Notices]
[Page 80654]
[FR Doc No: 2016-27450]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 [Docket No. CP15-558-000]

PennEast Pipeline Company, LLC; Notice of Revised Schedule for
Environmental Review of the PennEast Pipeline Project

    This notice identifies the Federal Energy Regulatory Commission
(FERC or Commission) staff's revised schedule for the completion of the
environmental impact statement (EIS) for PennEast Pipeline Company,
LLC's (PennEast) PennEast Pipeline Project. The first notice of
schedule, issued on March 29, 2016, identified December 16, 2016 as the
EIS issuance date. Based on new route modifications filed by PennEast.
The Commission staff intend to issue a notice to newly affected
landowners. Commission staff has therefore revised the schedule for
issuance of the final EIS.

Schedule for Environmental Review

Issuance of Notice of Availability of the final EIS, February 17, 2017
90-day Federal Authorization Decision Deadline, May 18, 2017

    If a schedule change becomes necessary, an additional notice will
be provided so that the relevant agencies are kept informed of the
project's progress.

Additional Information

    In order to receive notification of the issuance of the EIS and to
keep track of all formal issuances and submittals in specific dockets,
the Commission offers a free service called eSubscription (https://www.ferc.gov/docs-filing/esubscription.asp).

    Dated: November 8, 2016.
Kimberly D. Bose,
Secretary.
[FR Doc. 2016-27450 Filed 11-15-16; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 197 (Friday, October 13, 2017)]
[Notices]
[Pages 47749-47750]
[FR Doc No: 2017-22196]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-5974]

``Determining Whether To Submit an Abbreviated New Drug
Application or a 505(b)(2) Application;'' Draft Guidance for Industry;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled
``Determining Whether to Submit an ANDA or a 505(b)(2) Application.''
This guidance is intended to serve as a foundational guidance to assist
applicants in determining which one of the abbreviated approval
pathways under the Federal Food, Drug, and Cosmetic Act (the FD&C Act)
is appropriate for the submission of a marketing application to FDA.

DATES: Submit either electronic or written comments on the draft
guidance by December 12, 2017 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: 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): 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-5974 for ``Determining Whether to Submit an ANDA or a
505(b)(2) Application.'' 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 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 http://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 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 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)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Elizabeth Giaquinto Friedman, Center
for Drug Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Rm. 1670, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Determining Whether to Submit an ANDA or a 505(b)(2)
Application.'' This guidance is intended to serve as a foundational
guidance to assist applicants in determining which one of the
abbreviated approval pathways under the FD&C Act is appropriate for the
submission of a marketing application to FDA. This guidance highlights
criteria for submitting applications under the abbreviated approval
pathways described in section 505(j) and 505(b)(2) of the FD&C Act (21
U.S.C. 355(j) and 21 U.S.C. 355(b)(2), respectively), identifies
considerations to help potential applicants determine whether an
application would be more appropriately submitted under section 505(j)
or under section 505(b)(2) of the FD&C Act, and provides direction to
potential applicants on requesting assistance from FDA in making this
determination.
    The Drug Price Competition and Patent Term Restoration Act of 1984
(Pub. L. 98-417) (the Hatch-Waxman Amendments) added section 505(b)(2)
and 505(j) of the FD&C Act, which describe abbreviated approval
pathways for drug products regulated by the Agency under the FD&C Act.
The Hatch-Waxman Amendments reflect Congress's efforts to balance the
need to ``make available more low cost generic drugs by establishing a
generic drug approval procedure'' with new incentives for drug
development in the form of exclusivities and patent term extensions.
With the passage of the Hatch-Waxman Amendments, the FD&C Act describes
different routes for obtaining approval of two broad categories of drug
applications: New drug applications (NDAs) and abbreviated new drug
applications (ANDAs).
    This guidance focuses on those applications that can be submitted
as ANDAs under section 505(j) of the FD&C Act, petitioned ANDAs under
section 505(j)(2)(C) of the FD&C Act, or NDAs under section 505(b)(2)
of the FD&C Act. This guidance does not discuss stand-alone NDAs.
    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 factors for
applicants to consider when determining whether to submit an ANDA or a
505(b)(2) application. 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.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. 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 21 CFR 314.94 have been approved under
OMB control number 0910-0001. The collection of information for
controlled correspondence and pre-ANDA meeting requests has been
approved under OMB control number 0910-0797.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated October 10, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-22196 Filed 10-12-17; 8:45 am]
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