Information Collection Request

Supporting Statement
for Information Collection Request
for the EPA's National Fish Program

Renewal ICR

July 2021

EPA ICR Number 1959.07
OMB Control No. 2040-0226
(Non-Regulatory)

U.S. Environmental Protection Agency
Office of Water
Office of Science and Technology
1200 Pennsylvania Avenue, NW
Washington, DC 20460

TABLE OF CONTENTS

Section	Page
1.	Identification of the Information Collection	1
1.1	Title of the Information Collection	1
1.2	Short Characterization/Abstract	1
2.	Need for and Use of the Collection	2
2.1	Need/Authority for the Collection	2
2.2 	Practical Utility/Users of the Data	3
3.	Non-duplication, Consultations, and Other Collection Criteria	5
3.1	Non-duplication	5
3.2	Public Notice Required Prior to ICR Submission to OMB	5
3.3	Consultations	5
3.4 	Effects of Less Frequent Collection	6
3.5	General Guidelines	6
3.6 	Confidentiality and Sensitive Questions	6
4.	Respondents and the Information Requested	6
4.1	Respondents/SIC Codes	6
4.2	Information Requested	7
(i)	Data items, including record keeping	7
(ii)	Respondent Activities	7
5. 	The Information Collected - Agency Activities, Collection Methodology, and Information Management	8
5.1	Agency Activities	8
5.2	Collection Methodology and Management	8
5.3	Small Entity Flexibility	9
5.4	Collection Schedule	9
6.	Estimating the Burden and the Cost of the Collection	9
6.1	Estimating Respondent Burden and Cost	9
6.2	Estimating Agency Burden and Cost	12
6.3	Reasons for Change in Burden	16
6.4	Burden Statement	16
Appendix A  -  Draft National Fish Program Evaluation	A-1
Appendix B  -  Email Request to States and Fish Advisory and Tissue Templates	B-1

1.	Identification of the Information Collection
1.1	Title of the Information Collection
Environmental Protection Agency (EPA) National Fish Program.
1.2	Short Characterization/Abstract
The Clean Water Act (CWA) Section 101(a)(2) interim goal provides for the protection and propagation of fish, shellfish, and wildlife and for recreation in and on the water. EPA includes the safe consumption of fish and shellfish as part of this fundamental CWA goal. There is a continuing need to maintain the overall quality and availability of public information concerning fish advisories, which includes, but is not limited to, water quality standards, monitoring and assessment activities, and the issuance of advisories and bans related to fish and shellfish consumption. Primary responsibility for these activities lies with states, territories, and tribes.
This ICR is for voluntary information collections under the national fish advisory program. EPA will analyze the information to determine what science, guidance, technical assistance, and nationwide information are needed to help state and tribes reduce risks to consumers, including those in underserved communities, of locally caught, contaminated fish. EPA will also use the information provided to facilitate information sharing and to ensure guidance documents are useful and technically accurate These information collections would help EPA advance equitable and effective fish advisory programs that protect recreational and subsistence fishers and other underserved populations from consumption of contaminated fish. This information is collected under the authority of CWA Section 104, which provides for the collection of information to be used to protect human health and the environment.
The information to be collected from states and tribes on a voluntary basis would include the following: (A) fish advisory information and fish tissue data collected to assist in making advisory decisions, once over a three-year period; (B) state or tribal fish program information for the National Fish Advisory Program Evaluation, once over a three-year period; and, (C) technical program information, from time to time. Over the three-year period of this ICR (2022-2025), the EPA will collect data/information on a voluntary basis from potentially 103 respondents which include states, tribes, and the Great Lakes Indian Fish & Wildlife Commission. EPA will analyze the information to determine what science, guidance, technical assistance, and nationwide information are needed to help state and tribes have equitable and effective fish advisory programs. In addition, EPA will also use the information provided to facilitate information sharing and to ensure guidance documents are useful and technically accurate.

      This ICR renews the EPA ICR Number 1959.07, OMB Control Number 2040-0226, which is approved through April 30, 2022. In this renewal, EPA anticipates the burden associated with the renewed ICR to be 1,181 hours annually, which again includes a National Program Evaluation and additional collections related to the President's priorities to support efforts to advance equity and environmental justice in fish advisory programs by ensuring that recreational and subsistence fishers and other underserved populations are protected from consumption of contaminated fish. The annual total cost from all potential respondents under this ICR is estimated to be $64,766.66 (11.5 hours at an average labor rate of $54.84 per hour per respondent for 103 respondents).

2.	Need for and Use of the Collection
2.1	Need/Authority for the Collection

 Authority:  CWA Section 104, which provides for the collection of information to be used to protect human health and the environment.

The nationwide collection of fish advisory information by EPA began in 1994 with a survey of the 50 states, the District of Columbia, and U.S. territories (Guam, American Samoa, Puerto Rico, and the U.S. Virgin Islands) and the Great Lakes Indian Fish & Wildlife Commission. In 2000, EPA began to collect such information from 36 tribes. The previous fish program surveys were voluntary surveys used to obtain both qualitative and quantitative advisory information on fish advisories and fish tissue data that served as the basis for these advisories. Both the advisory information and fish tissue data that EPA has collected so far are available publicly in the National Listing of Fish Advisories (NLFA) database at www.epa.gov/fish-tech. Over the years different ICRs included different collection activities. For example, the last ICR that included collection of fish advisory, fish tissue data, and programmatic information was in 2010, more than a decade ago. In 2014, the ICR included collection of fish advisory and fish tissue data, while in 2019, the ICR only included collection of fish tissue data.
The information to be collected on a voluntary basis under this ICR would include the following: (A) fish advisory information and fish tissue data collected to assist in making advisory decisions; (B) state or tribal fish program information for the National Fish Advisory Program Evaluation; and, (C) technical program information from time to time (such as technical comments from states and tribes on draft program policies and guidance documents; and information concerning program operations to assist in information sharing and improving program efficiency). EPA will analyze the collected information to determine what science, guidance, technical assistance, and nationwide information are needed to help state and tribes have effective fish advisory programs. EPA will also use the information provided to facilitate information sharing and to ensure guidance documents are useful and technically accurate. In addition, EPA will use the collected information to support its efforts to advance equity and environmental justice in fish advisory programs by ensuring that recreational and subsistence fishers and other underserved populations are protected from over-consumption of contaminated fish. The 2017 Report from the EPA Office of the Inspector General  -  EPA Needs to Provide Leadership and Better Guidance to Improve Fish Advisory Risk Communications - found that:
      Some subsistence fishers, tribes, sport fishers and other groups consume large amounts of contaminated fish without health warnings. Although most states and some tribes have fish advisories in place, this information is often confusing, complex and does not effectively reach those segments of the population. Fish advisories differ from state to state, between states and tribes, and across state and tribal borders, which in some cases leads to multiple advisories with conflicting advice for a single waterbody.

    (A) Fish Advisory Information and Fish Tissue Data Collection; and, (B) Fish Program Information for the National Fish Advisory Program Evaluation
Once over the three-year period of this ICR, EPA will collect from states and tribes, on a voluntary basis, the following: fish advisory information and fish tissue data collected to assist in making advisory decisions; and, state or tribal fish program information for the National Fish Advisory Program Evaluation.
Although fish advisory information is often available on state or tribal websites, it is not currently available in formats that can easily be combined to analyze trends, identify areas with environmental justice concerns, or identify which contaminants are having the greatest national impact on consumers of locally caught fish and recreational uses. With a national compilation of fish advisories, EPA will identify the overlap between waters with state/tribal fish advisories and areas with environmental justice concerns and make information available to states/tribes and the public. Additionally, the fish tissue data are useful for determining which pollutants states and tribes are monitoring for and the levels they are finding as well as identifying contaminants of emerging concern in fish tissue. The information collected under this ICR will increase the understanding of whether recreational and subsistence fishers as well as underserved communities are at additional risk of exposure to chemical contaminants through their consumption of locally caught fish and shellfish.
The information from the National Program Evaluation will provide information on the types of contaminants that trigger the issuance of advisories, the monitoring designs states and tribes use with respect to the numbers of samples collected and number of stations surveyed, the contaminants being analyzed in fish tissue, and the risk assessment methodology currently being used to evaluate the potential health risk to fish consumers. In addition, information such as what languages states/tribes use to communicate fish advisories to underserved communities, what fish consumption rates states/tribes use to support advisories, and what channels states/tribes use to communicate to target populations will be used by EPA to plan more effective research and policies to reduce risks to consumers, including underserved populations, of locally caught, chemically contaminated fish.

    (C) Voluntary Technical Program Information
      From time to time, EPA may request states and tribes to voluntarily provide information that would assist in administering state, tribal, regional and national fish advisory programs effectively and efficiently, and further cooperative federalism. For example, EPA may request technical information to assist in developing guidance or other materials; technical comments on draft program-related policies and guidance documents; and information concerning program operations to assist in information sharing and improving program efficiency. EPA may also invite state and tribal participation in program-related work groups. Submission of state or tribal information and participation by states and tribes in workgroups is voluntary.

2.2 	Practical Utility/Users of the Data
     (A) Fish Advisory Information and Fish Tissue Data Collection; and, (B) Fish Program Information for the National Fish Advisory Program Evaluation
The EPA uses the information collected to help states and tribes develop or implement equitable and effective fish advisory programs by:
 Enhancing the public's right-to-know about the safety of fish and shellfish harvested from local waters by making this information available online.
 Improving the scientific and policy foundations to support of state, territorial, tribal, and local actions.
 Providing up-to-date and technically accurate guidance on sampling and analysis methods, risk assessment, risk management, and risk communication procedures for the states, territories and tribes to use to better protect the health of recreational and subsistence fishers in a more timely and comprehensive manner.

Fish tissue contaminant data helps to characterize the pollutants that trigger fish advisories. For many years, mercury, dioxins/furans, polychlorinated biphenyls (PCBs), chlordane, and dichlorodiphenyl-trichloroethane (DDT) have accounted for most of the advisories issued nationwide. More recently, states and tribes are beginning to issue advisories for per- and polyfluoroalkyl substances (PFAS). Regular collection of fish tissue information allows the evaluation of whether waters under advisories are meeting water quality standards, so that trends can be identified, and resources allocated to deal with the pollutants of greatest concern. It will help with identifying bioaccumulative pollutants of emerging concern in fish.

      The information collected will be compiled to determine the status and nature of chemical contamination in the nation's waters and the level of effort by jurisdictions to monitor and evaluate fish tissue data at their monitoring sites. The information collected will also help EPA determine the successes and challenges that states and tribes have experienced in the implementation of EPA guidance recommendations in fish advisory programs. EPA will analyze the information to determine what science, guidance, technical assistance, and nationwide information are needed to help state and tribes reduce risks to consumers, including those in underserved communities, of locally caught, chemically contaminated fish. In addition, EPA will also use the information provided to facilitate information sharing and to ensure guidance documents are useful and technically accurate.
The information collected under this ICR will allow state, tribes, and local organizations, to easily review cumulative information on fish monitoring and advisory programs to address water quality concerns directly related to chemical contamination of fish. EPA will use this data to analyze trends over time, identify areas with environmental justice concerns, and identify which contaminants are having the greatest national impact on consumers of locally caught fish and recreational uses. EPA's Office of Water will share this information with other EPA program offices, such as the Office of Research and Development and the Office of Policy, to evaluate scientific research needs and policy implications. EPA regional offices also could use the information to address regional concerns regarding fish advisories and monitoring programs. The Centers for Disease Control and Prevention and other federal agencies will also be able to use this information.
Summary and individual state/tribal fish advisory and fish tissue data will also be made available to non-governmental organizations and the public. By accessing the data through the one national dataset on the Internet, the public will be able to determine whether the waterbody they want to fish has been monitored to assess the level of chemical contamination in the fish. This data coupled with advisory information will provide consumers with information that they can use to make informed decisions on waterbodies they fish in, the amount and types of fish they consume and how to prepare fish caught in local waters for recreation and subsistence to reduce health risks.
    (C) Voluntary Technical Program Information
EPA will use technical program information provided voluntarily under 2.1(C) above: to help make program-related policies and guidance documents useful and technically accurate; to facilitate sharing of information; and, to improve program efficiency.
3.	Non-duplication, Consultations, and Other Collection Criteria
3.1	Non-duplication
The survey of fish advisories has been performed under an approved ICR for the National Listing of Fish Advisories (OMB Control No. 2040-0226; EPA ICR No. 1959.01, expired on 01/31/2004; EPA ICR No. 1959.02, expired on 09/30/2007; EPA ICR No. 1959.03, expired on 02/28/2011; EPA ICR No. 1959.04, expired on 11/30/2014; EPA ICR No. 1959.05 expiring on 07/31/2018; EPA ICR No. 1959.06 expiring on 4/30/2022). This ICR is a renewal to gather fish advisory information and fish tissue data, fish advisory programmatic information, and technical program information.
Additionally, based on repeated requests from states for information on how other states and tribes implement their fish advisory programs, EPA plans to collect fish advisory program information, for the first time in more than 11 years, as part of the National Fish Advisory Program Evaluation (see Appendix A).
Information collected under this ICR are already collected by state, territorial and/or tribal fish programs. Consequently, respondents would not be collecting data specifically for EPA, but instead sharing their individual data with EPA for national consolidation and reporting.

3.2	Public Notice Required Prior to ICR Submission to OMB
This section will be completed after the Federal Register Notice is published.

3.3	Consultations
In 2017, EPA sought input on burden hours from 9 jurisdictions (Alaska, Arizona, Delaware, Maryland, Michigan, New York, Utah, Great Lakes Fish and Wildlife Consortium, and the Aroostook Band of Micmacs) for calculating burden estimates. Delaware, Michigan and Utah provided burden hours for reviewing instructions, and entering fish advisory and fish tissue data into each respective template. EPA used these burden estimates for this supporting statement and plans to seek input from a sample of respondents to update burden estimates for the final ICR package. For the collection of information for the National Fish Advisory Program Evaluation, EPA used burden estimates from the last survey conducted in 2010 and will also update estimates based on input from a sample of respondents for the final ICR package.

3.4 	Effects of Less Frequent Collection

     (A) Fish Advisory Information and Fish Tissue Data Collection; and, (B) Fish Program Information for the National Fish Advisory Program Evaluation
    EPA estimates that voluntary requests will be sent to potential respondents once over a three-year period for: information on fish advisories and fish tissue data, and for fish program information for the National Fish Advisory Program Evaluation.

     (C) Voluntary Technical Program Information
    EPA issues requests on an ad hoc basis and limits the number of such requests to as few as possible. Such requests are generally cleared by senior managers before being initiated. The Agency often coordinates in advance with state and tribal associations to determine the nature and timing of such requests. In all cases, states' and tribes' submission of program information and participation in workgroups is voluntary.

3.5	General Guidelines
      This ICR is in compliance with the OMB guidelines found 5 CFR 1320.5(d)(2).

3.6 	Confidentiality and Sensitive Questions
State and authorized tribal submissions to EPA under this ICR will contain no confidential or sensitive information.

4.	Respondents and the Information Requested
4.1	Respondents/SIC Codes
      The following describes the universe of potential respondents.

 "States" described as respondents in this ICR refers to the 50 states, the District of Columbia, and five territories (i.e., 56 "states").
 "States and authorized tribes" in this ICR refers to the 102 entities with WQS: the 56 states defined above and any federally-recognized Indian tribes that have EPA approved WQS. As of May 2021, there were 46 such tribes.
 Great Lakes Fish and Wildlife Commission.

      The state and tribal respondents affected by this collection activity are in:
 NAICS code 92411 ( "Administration of Air and Water Resources and Solid Waste Management Programs"), formerly SIC code #9511.
 NAICS code 92312 ( "Administration of public health programs"), formerly SIC code #9431.

4.2	Information Requested
(i)	Data items, including record keeping
     	(A) Fish Advisory Information and Fish Tissue Data Collection; and, (B) Fish Program Information for the National Fish Advisory Program Evaluation
      The information that the EPA is requesting states, territories and tribes to voluntarily provide under this ICR is already routinely collected as part of their fish monitoring efforts to protect public health. No additional collection effort will be required by these entities in order to respond to EPA's request for the following:
 Tissue data that supports the advisory determination including contaminant, contaminant concentration, type(s) of sample(s) (e.g., fillet, whole, plug, shellfish, wildlife, composite), sample length, and locational coordinates for the data/sample locations (e.g., station IDs, site names, locations, counties, latitude/longitude); or any other fish tissue data (even if it was not used to issue an advisory).
 Fish advisory information including waterbody assessed with locational information, advisory extent, species (and species size) under advisory, contaminant causing advisory, population affected by advisory, meal size recommendation and frequency fish can be consumed.
 Information on state fish advisory programs, including differences in monitoring procedures used to collect and analyze fish samples, risk assessment methodologies used to evaluate chemical residue data and issue advisories, risk management approaches employed to protect the public, and risk communication procedures used to communicate the human health risks associated with the consumption of chemically contaminated species.

    (C) Voluntary Technical Program Information

      From time to time, EPA may request technical information from states and tribes in support of its effective and efficient administration of regional and national fish advisory program. Such information would relate directly to a state or tribe's program and would likely consist of technical information to assist in developing guidance or other materials; technical input used by EPA in developing program-related policies and guidance; information concerning program operations to assist in information sharing and improving program efficiency; and information provided when participating in program-related EPA work groups. Submission of state or tribal information and participation in EPA work groups is voluntary.

(ii)	Respondent Activities
EPA identified the following activities respondents may need to undertake under this ICR to voluntarily respond to the information collection.
 Review information requested and instructions on submitting fish tissue data and advisory information. States, territories and tribes will have the flexibility to submit their data to the EPA in the manner that is most convenient and efficient for them.
 Gather fish advisory information and fish tissue data for electronic submission.
 Prepare transmittal email to submit fish advisory information and fish tissue data to EPA.
 Review instructions and questions in the National Fish Advisory Program Evaluation (approximately 100 questions).
 Gather information needed to complete questions on the Program Evaluation.
 Complete and submit online Program Evaluation.
 Provide voluntary information in response to requests, providing voluntary technical input to EPA policies, guidance documents, and workgroups.

5. 	The Information Collected - Agency Activities, Collection Methodology, and Information Management
5.1	Agency Activities
Agency activities associated with this ICR consist of the following:
 Updating current mailing list of state, territory, and tribal fish advisory programs
 Preparing transmittal email and instructions for suggested ways to submit fish advisory and tissue data, fish advisory program information and technical program information..
 Sending voluntary information requests to respondents and respond to any questions from them.
 Compiling information and data from respondents.
 Entering data and information into a database.
 Analyzing fish advisory information for summary statistics for communications to states, tribes, territories and the public.
 Preparing and conducting the online Evaluation information collection questionnaire.
 Analyzing information collected as part of the Evaluation.
 Preparing requests for technical information.
 Compiling and analyzing results.

5.2	Collection Methodology and Management
All state, territorial, or tribal respondents on the mailing list developed and maintained by EPA will receive email requests to voluntarily provide fish advisory information and fish tissue data, provide information for the National Fish Advisory Program Evaluation, and periodic technical program information. The EPA periodically, and at least annually, checks in with fish advisory program managers to ensure we have the correct contacts listed on EPA's Fish Program website. The transmittal email will explain the purpose of the information/data collection effort, the voluntary nature of the request, and the instructions on how to submit the data to EPA. An example transmittal email request is included in Appendix B. States, territories and tribes have the flexibility to submit their data to the EPA in the manner that is most convenient and efficient for them or to choose not to participate.

5.3	Small Entity Flexibility
The reporting requirements discussed in this ICR do not place an unreasonable burden on small entities. The submission of information under this ICR is voluntary. Thus, smaller entities that cannot provide the staff and resources to respond to EPA's information request are not required to do so. Identification of such smaller entities that do not initially respond will allow EPA to develop options to assist these smaller entities. Options may include additional time for responding, simplifying the response procedures, providing assistance in completing the request or forgoing the response.

5.4	Collection Schedule
EPA estimates that voluntary requests will be sent to potential respondents once over a three-year period for: information on fish advisories and associated fish data; and, fish program information for the National Fish Advisory Program Evaluation.  In addition, from time to time, EPA may request states and tribes to provide information voluntarily that would assist in administering state and tribal, fish advisory programs effectively and efficiently.
6.	Estimating the Burden and the Cost of the Collection
6.1	Estimating Respondent Burden and Cost
   In this section, EPA calculates respondent burden and costs.
 The respondent burden for each collection is generally based on estimates of the number of responses expected multiplied by estimates of the burden hours for each response.
 The respondent labor cost for each collection is based on the burden hours calculated above multiplied by estimated personnel compensation rates for each class of respondent. These rates are estimated as follows:
 Labor rates were obtained from the Bureau of Labor Statistics' Employer Costs for Employee Compensation  -  December 2020 (USDL- 21-0437, March 18, 2021) at http://www.bls.gov/news.release/pdf/ecec.pdf, and the following categories were used:
 Manager (White collar: Executive, administrative, and managerial)

 $64.02/hour
 Technical (White collar)

 $51.54/hour
      Rates are total compensation which includes cost for wages and salaries and benefits, as reported by Bureau of Labor Statistics.

 The respondent Operations and Maintenance (O&M) expenses are estimated separately.
 No capital/start-up costs are anticipated for the jurisdictions responding to the data request because they already collect the information requested for the public record.
 No operations and maintenance (O&M) cost are anticipated. Jurisdictions already maintain the information requested in this collection for the public record and will submit this information to the EPA electronically. Currently, all jurisdictions provide the fish advisory and tissue data via email. The information request for the National Fish Advisory Program Evaluation will be online, with a link shared with respondents to complete it.

 Fish Advisory Information and Fish Tissue Data Collection
The EPA considered its previous burden estimates for collecting fish tissue and fish advisory information and revised them based on responses received from three states (see section 3.3). The annual respondent burden and cost presented in Table 1 reflects the estimated average annual labor hours and costs, calculated to occur during the three-year OMB-approved period of this ICR.
       Labor hours are based on initial assumptions that up to 103 potential respondents will be asked to provide fish advisory information and fish tissue data, once during the three-year period of the ICR.
 Senior-level managers (e.g., director, chief) are most likely to receive the data request and review instructions; however, it is anticipated that a lower-level technical staff member would provide the fish advisory information and fish tissue data electronically to EPA. The amount of time needed to gather advisory information varies considerably, depending on how many new fish advisories have been issued within the jurisdiction during the past three-year period and/or how many revisions there are to previously issued advisories. The amount of time needed to complete the new advisory information or update existing information will vary depending on the number of advisories within the respondent's jurisdiction. For the purposes of this ICR, EPA estimates (based on the responses from three states), on the average, that it will require 4.40 hours to provide fish advisory information and fish tissue data once in the three-year period of this ICR. If available, the information requested is already compiled by each jurisdiction for the public record; hence little, if any, additional time will be needed to gather the information.

             State and tribal total respondent burden hours, based on 103 respondents, once in the three-year period of the ICR:
               (1.10 manager-hours) * (103 respondents) = 113 total manager hours once in three years, or annual manager hours of 38
               (3.30 technical-hours) * (103 respondents) = 340 total technical hours once in three years, or annual technical hours of 113

             State and tribal total estimated costs, based on 103 respondents, once in the three-year period of the ICR:
                [(113 total manager-hours) * ($64.02 per hour)] + [(340 technical -hours) * ($51.54 per hour)] = $24,757.86 once in three years, or an annual total cost of $8,252.62

 Fish Program Information for the National Fish Advisory Program Evaluation
       Once in three-year period of this ICR, EPA will conduct an evaluation of the fish advisory programs via an online survey to determine the status of state and tribal fish advisory programs considering that EPA conducted the last evaluation in 2010. Senior-level managers (e.g., director, chief) are most likely to receive the requests related to the National Fish Advisory Program Evaluation; however, it is anticipated that a lower-level technical staff member would actually complete the survey electronically. Thus, it is estimated that the manager and the technical person could together spend a total of 12 hours once in the three-year period of this ICR to the responding to the Program Evaluation, as shown below:
 State and tribal total respondent burden hours, based on 103 respondents, once in the three-year period of the ICR:
      (2.00 manager-hours) * (103 respondents) = 206 total manager hours once in three years, or annual manager hours of 69
      (10 technical-hours) * (103 respondents) = 1030 total technical hours once in three years, or annual technical hours of 343
 State and tribal total estimated costs, based on 103 respondents, once in the three-year period of the ICR:
       [(206 total manager-hours) * ($64.02 per hour)] + [(1030 technical-hours) * ($51.54 per hour)]  = $66,274.32 once in three years, or an annual total cost of $22,091.44

 Voluntary Technical Program Information
      The program information in this collection includes: technical information to assist in developing guidance or other materials; technical comments on draft program-related policies and guidance documents; information concerning program operations to assist in information sharing and improving program efficiency; and state and tribal technical materials prepared for program-related work groups. Submission of state or tribal information or participation by state and tribes in workgroups is voluntary. EPA estimates that it will make 3 requests for supporting technical program information from states and authorized tribes per year and it will take states or tribes an average of two hours to respond to an individual request. Thus, it is estimated that both the manager and the technical person together could spend a total of 6 hours per year per request (equivalent to a total of 18 hours for the three-year period of the ICR) to respond to the Voluntary Technical Program Information requests, as shown below:
 State and tribal total respondent burden hours, based on 103 respondents, for the three-year period of the ICR:
      (6 manager-hour) * (103 respondents) = 618 total manager hours for the three-year ICR period, or annual manager hours of 206
      (12 technical-hours) * (103 respondents) = 1,236 total manager hours once in three years, or annual manager hours of 412
 State and tribal total estimated annual costs, based on 103 respondents:
       [(618 total manager-hours) * ($64.02 per hour)] + [(1236 technical-hours) * ($51.54 per hour)] = $103,267.80 for the three-year period of the ICR, or an annual total cost of $34,422.60 per year

Table 1. Respondent Burden and Cost
Information Collection Activity
                       Hours and Costs Per Respondent

                            Total Hours and Costs

                      Mgr. Hours at $64.02/ Hour, Annual
      (# in parenthesis is
 3-year total)
                         Tech. Hours at $51.54/ Hour,
                                    Annual
                      (# in parenthesis is 3-year total)
                                 Resp. Hours,
                                    Annual
(# in parenthesis is 3-year total)
                           Labor Cost per Respondent
                             Capital Start-Up Cost
                                 O&M Cost
                               No. of Resp. [1]
                              Total Resp. Hours,
                                    Annual
(# in parenthesis is
3-year total)
                               Total Resp. Cost,
                                    Annual
                      (# in parenthesis is 3-year total)
 Fish Advisory & Fish Tissue Data Collection to be collected once in three years
Fish advisory/tissue collection (includes reviewing request, compiling and submitting information requested)
                                     0.37
                                    (1.10)
                                     1.10
                                    (3.30)

                                     1.47
                                    (4.40)

               varies (depending on manager and technical hours)
                                     $0.00
                                     $0.00
                                      103
                                      151
                                     (453)

                                   $8,252.62
                                 ($24,757.86)

 Fish Program Information for the National Fish Advisory Program Evaluation to be collected once in three years
National Fish Advisory Program Evaluation (includes reviewing request, compiling and submitting information requested)
                                     0.67
                                    (2.00)

                                     3.33
                                    (10.00)
                                     4.00
                                    (12.00)

               varies (depending on manager and technical hours
                                     $0.00
                                     $0.00
                                      103
                                      412
                                    (1,236)

                                  $22,091.44
                                 ($66,274.32)

   (C) Voluntary Technical Program Information to be collected annually
Voluntary Technical Program Information (includes request for technical information for guidance development and/or participation in workgroup)
                                     2.00
                                    (6.00)

                                     4.00
                                    (12.00)

                                     6.00
                                    (18.00)

               varies (depending on manager and technical hours
                                     $0.00
                                     $0.00
                                      103
                                      618
                                    (1854)

                                  $34,422.60
                                 ($103,267.80)

Grand Total for all three information collections (A), (B) and (C)
                                     3.03
                                    (9.10)

                                     8.43
                                    (25.3)

                                     11.5
                                    (34.4)

               varies (depending on manager and technical hours
                                     $0.00
                                     $0.00
                                      103
                                    1181.07
                                   (3,543.2)

                                  $64,766.66
                                 ($194,299.98)

[1]Calculations are based on the total number of respondents but actual responses may vary.

6.2	Estimating Agency Burden and Cost
	In this section, EPA calculates Agency burden and costs. Federal employee rates were obtained from the 2021 OPM General Schedule (GS) Salary Table for the Washington, DC, area for the midpoint (i.e., Step 5) of each salary grade (Available at the http://www.opm.gov/policy-data-oversight/pay-leave/salaries-wages/salary-tables/pdf/2021/DCB_h.pdf), and the following categories were used:

Manager (GS 15)
$125.23/hour
Technical (GS 13)
$90.10/hour

These hourly rates include overhead costs and locality pay of 30.48% for the Washington-Baltimore-Arlington, DC-MD-VA-WV-PA area and a 1% General Schedule increase effective January 2021. A benefits multiplication factor of 1.6 was used to obtain the total labor cost for the EPA.

 The Operations and Maintenance (O&M) expenses are estimated separately.
 There are no capital/startup costs anticipated for the Agency. The database for storing fish tissue data is already in place. No Agency or contractor labor for this activity is anticipated.
 O&M costs are anticipated for storing and archiving fish advisory information and fish tissue data.
    Table 2 includes the estimated costs for data collection and other activities in the three-year of the ICR period. The following resources and assumptions were used to prepare the burden estimate for each activity

 Fish Advisory Information and Fish Tissue Data Collection
 Once in the three-year period of the ICR, EPA will collect fish advisory information and fish tissue data.  For all agency activities associated with this data collection effort, EPA estimates the following burden and cost as shown below:
          Agency total burden hours based on 103 respondents, once in the three-year period of the ICR:
               (0.7 manager-hour) * (103 respondents) = 72 total manager-hours once in three years, or annual manager hours of 24
               (4.3 technical-hours) * (103 respondents) = 443 total technical-hours once in three years, or annual technical hours of 148
          Agency total estimated costs, based on 103 respondents, once in the three-year period of the ICR:
                [(72 total manager-hours) * ($125.23 per hour)] + [(443 technical-hours) * ($90.10 per hour)] = $48,930.86 or an annual total cost of $16,310.29
 O&M costs are anticipated for storing and archiving fish advisory information and fish tissue data.
 Fixed O&M costs include an estimate for computer equipment maintenance for this program of $1,000 per year and $5,000 per year for contractor services to maintain the database and perform troubleshooting, if needed.

 Fish Program Information for the National Fish Advisory Program Evaluation
 Once in the three-year period of the ICR, EPA will conduct a National Fish Advisory Program Evaluation to understand the status of state, territorial and tribal fish advisory program implementation.
 For all agency activities associated with the National Fish Advisory Program Evaluation, EPA estimates the following burden and cost as shown below:
          Agency total burden hours based on 103 respondents, once in the three-year period of the ICR:
         (1.2 manager-hour) * (103 respondents) = 124 total manager-hours once in three years, or annual manager hours of 41
         (8.0 technical-hours) * (103 respondents) = 824 total technical-hours once in three years, or annual technical hours of 275
          Agency estimated annual costs, based on 103 respondents, once in the three-year period of the ICR:
          [(124 total manager-hours) * ($125.23 per hour)] + [(824 technical-hours) * ($90.10 per hour)] = $89,770.92, or an annual total cost of $29,923.64

 No O&M costs are expected.

(C) 	Voluntary Technical Program Information
      EPA estimates it will make 3 requests annually for voluntary fish program information from states and authorized tribes. The Agency estimates that each request will average 6 hours per request (equivalent to 54 hours for the three-year period of the ICR) to develop the request and to compile and analyze the results, as shown below:

 Agency burden hours per year, based on 103 respondents, for the three-year period of the ICR:
      (9.0 manager-hours) * (103 respondents) = 927 total manager-hours once in three years, or annual manager hours of 309
      (45.0 technical-hours) * (103 respondents) = 4,635 total technical-hours once in three years, or annual technical hours of 1,545
 Agency estimated total annual costs, based on 103 respondents:
       [(927 total manager-hours) * ($125.23 per hour)] + [(4,635 technical-hours) * ($90.10 per hour)] = $533,701.71 for the three-year period of the ICR, or an annual total cost of $177,900.57

                        Information Collection Activity
                         Annual Hours Burden and Cost

                            Total Hours and Costs

                         Mgr. Hours at $125.23/ Hour,
                                    Annual
                      (# in parenthesis is 3-year total)
                          Tech Hours at $90.10/ Hour,
                                    Annual
                      (# in parenthesis is 3-year total)

                            Agency Hours per Resp,
                                    Annual
                      (# in parenthesis is 3-year total)
                            Labor Cost per Resp.[1]
                            Capital/ Start-Up Cost
                             Fixed O&M Cost[1]
                                    Annual
                              Number of Resp.[2]
                          Total Fixed O&M, Annual
                              Total Agency Hours,
                                    Annual
                      (# in parenthesis is 3-year total)
                              Total Agency Cost,
                                    Annual
                             (# in parenthesis is
                                 3-year total)
 Fish Advisory & Fish Tissue Data Collection to be collected once in three years
Fish advisory/tissue collection (includes updating mailing list, preparing transmittal email and instructions, sending request, compiling information, entering into database and analyzing data and O/M cost for storing fish advisory and tissue data)
                                     0.23
                                    (0.70)
                                     1.43
                                    (4.30)
                                     1.67
                                    (5.00)
                                    varies
                                     $0.00
                                    $6,000
                                      103
                                    $6.000
                                    171.67
                                     (515)
                                  $22,310.29
                                 ($66,930.86)
 Fish Program Information for the National Fish Advisory Program Evaluation  to be collected once in three years
National Fish Advisory Program Evaluation (includes developing evaluation instrument, conducting evaluation and analyzing results)
                                     0.40
                                    (1.20)
                                     2.67
                                    (8.00)
                                     3.07
                                    (9.20)
                                    varies
                                     $0.00
                                     $0.00
                                      103
                                     $0.00
                                    315.87
                                    (947.6)
                                  $29,923.64
                                 ($89,770.92)
 Voluntary Technical Program Information to be collected annually
Voluntary Technical Information request includes preparing requests and compiling and analyzing results
                                     3.00
                                    (9.00)
                                     15.00
                                    (45.00)
                                     18.00
                                    (54.00)

                                    varies
                                     $0.00
                                     $0.00
                                      103
                                     $0.00
                                     1854
                                    (5,562)
                                  $177,900.57
                                 ($533,701.71)
Grand Total for all three information collections (A), (B) and (C)
                                     3.63
                                    (10.90)
                                     19.10
                                    (57.30)
                                     22.73
                                    (68.20)

                                    varies
                                     $0.00
                                    $6,000
                                      103
                                    $6,000
                                   2,341.53
                                  (7,024.60)
                                  $230,134.50
                                 ($690,403.49)
Table 2. Agency Burden and Cost
    [1]Includes costs of contractor services.
    2 Calculations are based on the total number of respondents but actual responses may vary since responses are voluntary.

6.3	Reasons for Change in Burden
The Fish Advisory Program annual ICR burden has fluctuated over the program's history because the ICRs included different collection activities. Therefore, annual burden hours and dollars are not always directly comparable between ICRs. For example, the currently approved (2019) ICR only has one collection activity while this renewal ICR includes additional activities some of which have been included in prior collections. Although this ICR renewal's burden estimate is comparable or lower than annual burden in the 2010 or 2014 ICRs, there is an increase to the annual respondent burden hours (from 578 to 1,181) and an increase to the respondent cost from the 2019 ICR (from $25,968 to $64,766.66). As described in section 2.1, EPA is adding information collections on a voluntary basis for several reasons, including to support its efforts to advance equity and environmental justice in fish advisory programs. The information will help EPA determine what science, guidance, technical assistance, and nationwide information are needed to help state and tribes have equitable and effective fish advisory programs that protect recreational and subsistence fishers and other underserved populations from consumption of contaminated fish. In addition, EPA will also use the information provided to facilitate information sharing and to ensure guidance documents are useful and technically accurate. The net increase in annual respondent burden from the 2019 ICR comprises of the following changes:
 Addition of 151 hours and $8,252.62 costs for the voluntary information collection (A) - Fish Advisory Information and Fish Tissue Data Collection (to be requested once in the three-year period of this ICR)
 Addition of 412 hours and $22,091.44 costs for the voluntary information collection (B) - Fish Program Information for the National Fish Advisory Program Evaluation (to be requested once in the three-year period of this ICR)
 Addition of 618 hours and $34,422.60 costs for the voluntary and periodic information collection (C) - Voluntary Technical Program Information (to be collected from time to time).

6.4	Burden Statement
The public reporting and record keeping burden for this voluntary collection of information is estimated to average 11.5 hours per respondent annually. The primary requests to respondents would only occur once during this 3-year ICR period. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information requirement; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor and a person is not required to respond to a collection of information unless it displays a currently valid OMB control number. These numbers for the EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.
To comment on the EPA's need for this information, the accuracy of the provided burden estimates and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OW-2014-0350. An electronic version of the public docket is available online for viewing at http://www.regulations.gov. Use http://www.regulations.gov to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select "search," then type in the docket ID number identified above. Comments can also be submitted by email to<EMAIL_ADDRESS>or by mail to: EPA Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania Ave., NW, Washington, DC 20460. Additionally, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17[th] Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include EPA Docket ID (EPA-HQ-OW-2014-0350) and OMB Control Number (2040-0226) in any correspondence.


[Federal Register: January 23, 2009 (Volume 74, Number 14)]
[Notices]
[Page 4277-4279]
[DOCID:fr23ja09-117]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No: FAA-2008-1208]

Helicopter Emergency Medical Services Operations

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of consideration of comments.

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

SUMMARY: This notice discusses comments received on proposed revisions
to Operations Specification A021, pertaining to Helicopter Emergency
Medical Services (HEMS) operations, and Operation Specification A050,
pertaining to Helicopter Night Vision Goggle Operations (HNVGO) and
changes made to the proposed revisions based upon comments received.

FOR FURTHER INFORMATION CONTACT: For technical questions regarding the
A021 and A050 Operations Specifications revisions contact: Dennis
Pratte or Larry Buehler, FAA Flight Standards--Part 135 Air Carrier
Operations Branch, AFS-250, Federal Aviation Administration, 800
Independence Avenue, SW., Washington, DC 20591; telephone (202) 267-
8166; e-mail<EMAIL_ADDRESS>or<EMAIL_ADDRESS>For legal
questions concerning this notice, contact: Dean Griffith, FAA Office of
the Chief Counsel, AGC-220, 800 Independence Avenue, SW., Washington,
DC 20591; telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Summary of Action

    On November 14, 2008, the FAA issued a notice of availability of
proposed revisions to Operations Specifications A021 and A050
pertaining to HEMS operations and requested comments to the proposed
revisions. The FAA received 25 comments in response to the notice and
has made changes to proposed Operations Specification A021 based on the
comments. Operations Specification A050 will not be changed.

Availability of Document

    Copies of Operations Specifications A021 (HEMS) and A050 (HNVGO)
which are to be implemented can be found and downloaded from the
Internet at the Federal eRulemaking Portal. Go to http://
www.regulations.gov and search for the documents using the Federal
docket number FAA-2008-1208.

Discussion of Comments Received

    The FAA received 25 comments from industry, including HEMS
operators (Omniflight Helicopters, Inc., Intermountain Life Flight, Air
Evac Lifeteam, EMS Executive Forum of HEMS Common Carriers), North
Memorial Medical Center North Air Care, Reach Air Ambulance, and
Hospital Wing), trade associations (Helicopter Association
International, the Association of Air Medical Services, and the
National EMS Pilots Association), an equipment manufacturer (Max-Viz
Inc.), and a designer of helicopter GPS approaches (STI, Inc.). The FAA
also received comments from pilots, HEMS medical personnel, and other
individuals. A summary of the comments received and the FAA response to
the comments follows.

A. General Support

    The FAA received numerous comments supporting proposed Operations
Specifications A021 and A050. Commenters supporting the revisions
included the EMS Executive Forum of HEMS Common Carriers, Helicopter
Association International (supported by Life Flight of Maine, TriState
Careflight, LLC, EMS Air Services of New York, Inc., Sanford USD
Medical Center Trauma 1, Bell Helicopter, and other organizations that
also submitted comments independently), the National EMS Pilots
Association, the Association of Air Medical Services, Omniflight
Helicopters, Inc., and several individual commenters.

B. Instrument Flight Rules (IFR) Point in Space (PinS) Special
Instrument Approach Procedures

    Several commenters recommended changes to proposed Operations
Specification A021 paragraph ``h,'' regarding IFR PinS Special
Instrument Approach Procedures, with a proceed Visual Flight Rules
(VFR) transition to a heliport or landing area, and standard or special
instrument approach procedures. The comments identified that the
language proposed in the operation specification could lead to
misunderstandings with respect to ``proceed VFR'' transitions and the
conduct of visual operations in accordance with visual minimums as
noted in A021 Table 1. Commenters also noted that if an approved
``proceed visually'' segment exists as part of an approved Instrument
Approach Procedure (IAP) or special IAP, the associated approach
minimums would apply.
    The FAA acknowledges that proposed Operations Specification A021
made no distinction between the weather minimums associated with an
instrument approach which ends in a ``proceed visually'' versus a
``proceed VFR'' instruction. The FAA agrees with the commenters that
the language in proposed A021 could lead to confusion for operators
making visual transitions from instrument approaches and therefore
intends to change A021 paragraph ``h,'' to clarify the procedures to be
followed when making VFR or visual transitions from instrument
approaches.

C. Weather Minimums

    Three commenters recommended different weather minimums from those
in the proposed Operations Specification A021. Two generally supported
higher weather minimums than the ones proposed by the FAA. The third
stated that the 5 mile visibility standard in mountainous terrain would
be too restrictive.
    Proposed Operations Specification A021 increases the weather
minimums for part 135 VFR flight by raising ceilings and increasing
visibility requirements. The FAA believes that the proposed weather
minimums will enhance safety for HEMS operations by lessening the
probability of encountering situations that could lead to inadvertent
operation into instrument meteorological conditions (IMC), pilot
spatial disorientation, or lack of situational awareness, all causes of
HEMS accidents.
    The first commenter who suggested higher weather minimums did not
provide supporting information for why minimums higher than the ones
proposed are warranted. The FAA agrees that as a general principle the
likelihood of controlled flight into terrain, loss of control, and
obstacle collisions decreases as weather minimums increase. However,
the FAA understands that HEMS operators provide an invaluable service
to the nation by providing crucial, safe, and efficient transportation
of critically ill and injured patients. The FAA believes that the new
weather minimums will help to prevent accidents by providing operators
a greater margin of safety without unnecessarily impinging upon
otherwise safe HEMS operations.

    The second commenter suggested higher weather minimums in
conjunction with the additional suggestion that pilots should have to
maintain a minimum of 300 feet AGL day, or 500 feet AGL night. The
commenter believes that the VFR flight planning requirement in proposed
A021, that requires vertical clearance of terrain and obstacles by 300
feet during the day and 500 feet at night, would place HEMS aircraft in
controlled airspace in high density traffic areas and in the flow of
fixed wing and IFR traffic. The commenter further states that in
controlled airspace the weather would have to be 500 feet above the
aircraft's altitude prohibiting flights although conditions are well
above VFR.
    In response to the commenter's suggested weather minimums which are
higher than the proposed A021's minimums for all but daytime local
flight, the FAA refers to its response to the first commenter in this
section. With respect to the concern about the proposed preflight
planning requirement, paragraph ``i'' of proposed A021 does not require
pilots to maintain the highest vertical clearance for the entire
flight. Rather, pilots may vary altitudes over portions of the flight.
Further, operators may plan flights so that major obstacles are not
along the planned route. Finally, paragraph ``i'' notes that pilots may
deviate from the planned flight path as required by conditions or
operational considerations.
    The third commenter expressed concern that the 5 mile visibility
requirement would unnecessarily restrict safe cross-country mountainous
terrain operations because night visibility of 3 to 5 miles under clear
skies due to haze is common in the Southeast United States during the
summer months. The FAA notes that operators have several options that
would allow them to operate under different minimums. These options
include IFR flight, adopting NVIS (Night Vision Imaging System) or
Terrain Awareness and Warning Systems (TAWS) technology, or
establishing local flying areas.

D. Technology on Board HEMS Aircraft

    One comment stated that the FAA has treated NVGs as a safety
appliance not for use ``to extend the `mission capabilities' of HEMS
aircraft'' nor to ``justify the reduction of Night VFR weather
minimums.'' The commenter asked for an explanation for why, in light of
the previous statement, the proposed A021 operations specification
allows decreased visibility and ceiling minimums when using NVIS.
    The FAA acknowledges the discrepancy with FAA Order 8900.1 which
states FAA policy that NVGs are to be approved only for the purpose of
enhancing operational safety. However, providing separate weather
minimums for night operations with NVIS is justified by several
factors. The Operations Specification A021 currently in effect, and
which has been in effect since January 2006, provides that HEMS
operators approved for NVG use may use high-lighting weather minimums
in low-lighting conditions if using NVG. The current operations
specification therefore permits NVG users to operate in weather
conditions not available to non-NVG users. The proposed operation
specification is essentially a continuation of current FAA practice as
it relates to HEMS operators. Further, NVIS technology has become more
sophisticated since the initial approval for operational use.
Additionally, the FAA is pursuing changes to Order 8900.1, which
provides instructions to FAA field inspectors, that would approve
agency grants of operational credit for NVG operations on a case-by-
case basis.
    Another commenter supported adopting Helicopter Terrain Awareness
and Warning Systems (HTAWS) rather than TAWS units which are not
helicopter specific because TAWS may add additional risk factors such
as distractions associated with nuisance warnings.
    The FAA disagrees that use of TAWS in helicopters creates
additional risk greater than the benefit provided and intends to permit
use of TAWS as initially proposed for Operations Specification A021.
The commenter is correct that use of certain TAWS units in helicopters
could potentially generate false alerts and ``nuisance warnings.''
However, the FAA supports voluntary implementation of TAWS in
helicopters. Although not helicopter specific, TAWS does provide
helicopter pilots with useful information pertaining to ground
proximity, helping to avoid controlled-flight into terrain, and improve
obstacle avoidance. In addition, the FAA has moved forward on
establishing production standards for helicopter-specific TAWS systems.
For example, the FAA published Technical Standards Order C194 to inform
manufacturers of the minimum performance standards required for HTAWS
for approval. HTAWS units developed to this standard will correct the
unique issues created by use of TAWS in rotorcraft. Additionally, HEMS
operators that wish to install HTAWS systems may do so; the terms of
the proposed Operations Specification A021 are not limited to TAWS
systems.
    One commenter objected to the use of the term ``NVIS'' in A021
Table 1, and stated that NVIS technology should be considered an
advisory technology no different than TAWS rather than included as an
associated technology with Night Vision Goggles (NVG). This commenter
further stated that the only technology associated with the proposed
operations specification that should require supplemental training or
currency is NVG technology.
    The use of the term ``NVIS'' to include NVG is consistent with FAA
usage. For example FAA Order 8900.1, Section 4.1126, states ``NVG is
the common term used for [NVIS] operations.'' Additionally, Radio
Technical Commission for Aeronautics, Inc. (RTCA), an FAA Advisory
Committee, states in Document 275, Minimal Operational Performance
Standards for Integrated Night Vision Imaging System Equipment, that
the term NVIS relates to the broader imaging system that includes the
NVG goggles as well as the cockpit windows, internal and external
lighting, and crew station design. Accordingly, the FAA intends to keep
the term NVIS in A021, Table 1. Note that the FAA does not intend to
extend NVIS to include systems other than NVG through this document.
    Another commenter suggested that aircraft equipped with Global
Positioning System (GPS) moving map displays should be excluded from
the requirement to document the highest obstacles along the flight
path.
    A key component of the revisions to A021 is to ensure that pilots
determine the minimum safe cruising altitude and required weather for
the flight before takeoff rather than making such assessments during
the flight. The FAA acknowledges that technologies, like GPS moving map
systems, may assist operators with managing risks associated with HEMS
operations. However, providing exceptions for technology to the
preflight requirement would defeat the purpose of making pilots aware
of the terrain and obstacles along the planned route of flight prior to
departing.
    Additional commenters suggested other technological enhancements
including requiring NVGs for all crew, and mandating satellite
tracking, autopilot, and weather radar for all operators.
    The FAA encourages HEMS operators to adopt technologies that would
provide additional safety measures; however, the revisions to A021 and
A050 focus on safety enhancements to the operational aspects of HEMS

operations rather than the equipment requirements for HEMS aircraft.

E. Maintaining Part 91 IFR Flight

    One commenter requested the ability to continue to fly IFR under
Part 91 using Part 135 weather minimums.
    Proposed Operations Specification A021 does not prohibit part 91
IFR operations. As noted in A021 paragraph ``d,'' operators equipped
and approved to so may elect to fly IFR following the part 91 IFR, or
more stringent, weather minimums. The weather minimums found in Table 1
apply to VFR flight segments in Class G airspace.

F. Part 135 Compliance for All HEMS Flights

    One commenter suggested requiring all segments of HEMS flights to
be flown under Part 135 operating requirements.
    This operations specification revision will increase safety for
HEMS operators by requiring all VFR segments of flights that include a
part 135 segment to adhere to increased weather minimums. This is an
important factor in preventing controlled flight into terrain, obstacle
collisions, inadvertent IMC, and spatial disorientation, or loss of
situational awareness. The FAA believes that the increased weather
minimums combined with the preflight planning requirements will provide
an increased margin of safety for HEMS operations. Operators equipped
and approved to do so may also elect to fly IFR which provides an
additional measure of safety to VFR flight due to factors such as
increased interaction with controllers, increased flight planning, and
guaranteed obstacle clearance while in controlled airspace. IFR flight
also provides the benefit of easier access to updated real-time en-
route and destination weather as well as Notice to Airmen (NOTAMS).
    The FAA has chosen to focus on the enhanced weather minimums and
preflight planning at this time because of the enhancements to safety
created by the proposed operations specifications, and the breadth of
the regulatory revisions required if the FAA were to require compliance
with part 135 for all HEMS operations.

G. Application to Public Aircraft

    Two commenters raised the issue of application of the proposed
operations specifications to public aircraft: One asked whether the
proposed operations specifications would apply to public aircraft,
another recommended applying A021 to all HEMS transports, whether
public or civil.
    The FAA intends to apply these operations specifications to part
135 HEMS operators currently required by their part 135 certificate to
obtain operations specifications, or to future HEMS operations that
obtain a part 135 certificate. The FAA will consider the public
aircraft issue separately.

H. Medical Personnel

    The FAA received several comments related to medical personnel that
serve on board HEMS aircraft. These comments included limiting the non-
patient transport related duties assigned to air-medical crew, flight
time and duty period limitations, incorporation of medical personnel
into safety aspects of HEMS operations, training requirements, and
recordkeeping requirements.
    The FAA recognizes that the air medical personnel are an important
part of a HEMS operation. However, these operations specifications
revisions focus on the flight operations and planning aspects of HEMS
operations; therefore requirements pertaining to medical personnel are
outside the scope of the revisions.

I. Other Comments

    The FAA received numerous comments on a number of other topics.
Topics included: Requiring HEMS operators to be based at full-service
airports; establishing regional dispatch centers for HEMS operations;
Requiring Commission on Accreditation of Medical Transport Systems
(CAMTS) certification for all operators; focusing on increased training
rather than more stringent operations specifications; permitting
landings only at preapproved landing sites; requiring two pilot crews;
requiring two engine aircraft; pilot testing on local area hazards and
procedures; operational credit for autopilot operations; use of common
radio frequencies; prohibiting HEMS operators from selling memberships;
establishment of obstacle free corridors; concern over pressure exerted
on flight crew to engage in operations by for-profit operators; the
FAA's role in making medical determinations; and continuing current
exemptions for operators.
    These comments are outside the scope of the operations
specifications revisions, relate to business decisions by HEMS
operators, or are already addressed by the operations specification.

    Issued in Washington, DC, on January 13, 2009.
John Duncan,
Manager, Air Transportation Division, AFS-200.
 [FR Doc. E9-1448 Filed 1-22-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 62 (Tuesday, March 31, 2020)]
[Notices]
[Pages 17874-17875]
[FR Doc No: 2020-06590]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0547; FRL--10006-22-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Performance Evaluation Studies on Wastewater
Laboratories (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Performance Evaluation Studies on
Wastewater Laboratories (EPA ICR Number 0234.13, OMB Control Number
2080-0021) to the Office of Management and Budget (OMB) for review and
approval in accordance with the Paperwork Reduction Act. This is a
proposed extension of the ICR, which is currently approved through May
31, 2020. Public comments were previously requested via the Federal
Register on October 9, 2019 during a 60-day comment period. This notice
allows for an additional 30 days for public comments. A fuller
description of the ICR is given below, including its estimated burden
and cost to the public. An agency may not conduct or sponsor and a
person is not required to respond to a collection of information unless
it displays a currently valid OMB control number.

DATES: Additional comments may be submitted on or before April 30,
2020.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0547, to (1) EPA online using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460, and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Gregory Savitske, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave. NW,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 564-0050; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: Discharge Monitoring Report-Quality Assurance (DMR-QA)
study program participation is mandatory for major and selected minor
National Pollutant Discharge Elimination System (NPDES) permit holders
in accordance with Clean Water Act Section 308. The DMR-QA study
program is designed to evaluate the analytic ability of laboratories
that perform chemical, microbiological and whole effluent toxicity
(WET) analyses required in NPDES permits for reporting results in the
Discharge Monitoring Reports (DMR). Under DMR-QA, the permit holder is
responsible for having their in-house and/or contract laboratories
analyze performance evaluation samples and submit results to
proficiency testing (PT) providers for grading. Graded results are
transmitted by either the permit holder or PT provider to the
appropriate federal or state NPDES permitting authority. Permit holders
are responsible for submitting corrective action reports to the
appropriate permitting authority.
    Form Numbers: EPA Form 6400-01.

    Respondents/affected entities: Major and selected minor permit
holders under the Clean Water Act's National Pollutant Discharge
Elimination System (NPDES).
    Respondent's obligation to respond: Mandatory under Clean Water Act
Section 308(a).
    Estimated number of respondents: 5,500 (total).
    Frequency of response: Annually, On occasion.
    Total estimated burden: 36,300 hours (per year) hours (per year).
Burden is defined at 5 CFR 1320.03(b)
    Total estimated cost: $5,368,055 (per year), includes $3,375,790
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 1,320 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This decrease is due to a slight decrease of NPDES
major permit holders over the last three years. Non-labor costs for
obtaining performance evaluation samples increased.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2020-06590 Filed 3-30-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 85, Number 243 (Thursday, December 17, 2020)]
[Rules and Regulations]
[Pages 81790-81792]
[FR Doc No: 2020-27621]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-1122; Project Identifier MCAI-2020-00972-T;
Amendment 39-21357; AD 2020-26-02]
RIN 2120-AA64

Airworthiness Directives; Yabor[atilde] Ind[uacute]stria
Aeron[aacute]utica S.A. (Type Certificate Previously Held by Embraer
S.A.) Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Yabor[atilde] Ind[uacute]stria Aeron[aacute]utica S.A. (type
certificate previously held by Embraer S.A.) Model ERJ 190-400
airplanes. This AD was prompted by a report of an in-flight shutdown
(IFSD) due in part to failure in the low-pressure compressor (LPC)
rotor 1 during operation in high altitude at high thrust settings. This
AD requires amending the airplane flight manual (AFM) to incorporate a
new limitation and revise certain normal procedures, as specified in an
Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC) AD, which
is incorporated by reference. The FAA is issuing this AD to address the
unsafe condition on these products.

DATES: This AD becomes effective January 4, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of January 4,
2021.
    The FAA must receive comments on this AD by February 1, 2021.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     Federal eRulemaking Portal: Go to https://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For the material incorporated by reference (IBR) in this AD,
contact National Civil Aviation Agency (ANAC), Aeronautical Products
Certification Branch (GGCP), Rua Dr. Orlando Feirabend Filho, 230--
Centro Empresarial Aquarius--Torre B--Andares 14 a 18, Parque
Residencial Aquarius, CEP 12.246-190--S[atilde]o Jos[eacute] dos
Campos--SP, BRAZIL, Tel: 55 (12) 3203-6600; Email<EMAIL_ADDRESS>
internet www.anac.gov.br/en/. You may find this IBR material on the
ANAC website at https://sistemas.anac.gov.br/certificacao/DA/DAE.asp.
You may view this IBR material at the FAA, Airworthiness Products
Section, Operational Safety Branch, 2200 South 216th St., Des Moines,
WA. For information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available in the AD docket at https://www.regulations.gov by searching for and locating Docket No. FAA-2020-
1122.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1122; or in person at
Docket Operations between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The AD docket contains this AD, any comments
received, and other information. The street address for Docket
Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Krista Greer, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    The ANAC, which is the aviation authority for Brazil, has issued
ANAC AD 2020-07-01, effective July 15, 2020 (ANAC AD 2020-07-01) (also
referred to as the Mandatory Continuing Airworthiness Information, or
the MCAI), to correct an unsafe condition for certain Yabor[atilde]
Ind[uacute]stria Aeron[aacute]utica S.A. (type certificate previously
held by Embraer S.A.) Model ERJ 190-400 airplanes.
    This AD was prompted by a report of an IFSD due in part to failure
in the LPC rotor 1 during operation in high altitude at high thrust
settings. The FAA is issuing this AD to address uncontained release of
the LPC rotor 1 and damage to the engine and airplane structure, which
could result in loss of control of the airplane. See the MCAI for
additional background information.

Related Service Information Under 1 CFR Part 51

    ANAC AD 2020-07-01 describes procedures for amending the AFM to
incorporate a new limitation and revise the normal procedures to limit
the engine N1 setting for flights above 33000 ft. This material is
reasonably available because the interested parties have access to it
through their normal course of business or by the means identified in
the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this AD because the FAA evaluated
all pertinent information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Requirements of This AD

    This AD requires accomplishing the actions specified in the MCAI
described previously, as incorporated by reference, except for any
differences identified as exceptions in the regulatory text of this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, ANAC AD 2020-07-01
is incorporated by reference in this final rule. This AD, therefore,
requires compliance with ANAC AD 2020-07-01 in its entirety, through
that incorporation, except for any differences identified as exceptions
in the regulatory text of this AD. Service information specified in
ANAC AD 2020-07-01 that is required for compliance with ANAC AD 2020-
07-01 is available on the internet at https://www.regulations.gov by
searching for and locating Docket No. FAA-2020-1122.

FAA's Justification and Determination of the Effective Date

    Since there are currently no domestic operators of these products,
notice and opportunity for public comment before issuing this AD are
unnecessary. In addition, for the reason stated above, the FAA finds
that good cause exists for making this amendment effective in less than
30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety and was not preceded by notice and an opportunity for public
comment. However, the FAA invites you to send any written comments,
data, or views about this AD. The most helpful comments reference a
specific portion of the proposal, explain the reason for any
recommended change, and include supporting data. To ensure the docket
does not contain duplicate comments, commenters should submit only one
copy of the comments. Send your comments to an address listed under the
ADDRESSES section. Include ``Docket No. FAA-2020-1122; Project
Identifier MCAI-2020-00972-T'' at the beginning of your comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, as well
as a report summarizing each substantive public contact with FAA
personnel concerning this AD. The FAA will consider all comments
received by the closing date for comments. The FAA may amend this AD
because of those comments.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Krista
Greer, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Any
commentary that the FAA receives that is not specifically designated as
CBI will be placed in the public docket for this rulemaking.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Costs of Compliance

    Currently, there are no affected U.S.-registered airplanes. If an
affected airplane is imported and placed on the U.S. Register in the
future, the FAA provides the following cost estimates to comply with
this AD:

                                                 Estimated Costs
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                                                                                Cost per
                    Action                                 Labor cost               Parts cost        product
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AFM revision..................................  1 work-hour x $85 per hour = $85              $0             $85
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Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    The FAA is issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: General requirements.
Under that section, Congress charges the FAA with promoting safe flight
of civil aircraft in air commerce by prescribing regulations for
practices, methods, and procedures the Administrator finds necessary
for safety in air commerce. This regulation is within the scope of that
authority because it addresses an unsafe condition that is likely to
exist or develop on products identified in this rulemaking action.

Regulatory Findings

    The FAA determined that this AD will not have federalism
implications under Executive Order 13132. This AD will not have 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.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2020-26-02 Yabor[atilde] Ind[uacute]stria Aeron[aacute]utica S.A.
(Type Certificate Previously Held by Embraer S.A.) Airplanes:
Amendment 39-21357; Docket No. FAA-2020-1122; Project Identifier
MCAI-2020-00972-T.

(a) Effective Date

    This AD becomes effective January 4, 2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Yabor[atilde] Ind[uacute]stria
Aeron[aacute]utica S.A. (type certificate previously held by Embraer
S.A.) Model ERJ 190-400 airplanes, certificated in any category, as
identified in Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o

Civil (ANAC) AD 2020-07-01, effective July 15, 2020 (ANAC AD 2020-
07-01).

(d) Subject

    Air Transport Association (ATA) of America Code 05, Time Limits/
Maintenance Checks.

(e) Reason

    This AD was prompted by a report of an in-flight shutdown (IFSD)
due in part to failure in the low-pressure compressor (LPC) rotor 1
during operation in high altitude at high thrust settings. The FAA
is issuing this AD to address uncontained release of the LPC rotor 1
and damage to the engine and airplane structure, which could result
in loss of control of the airplane.

(f) Compliance

    Comply with this AD within the compliance times specified,
unless already done.

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, ANAC AD 2020-07-01.

(h) Exceptions to ANAC AD 2020-07-01

    (1) Where ANAC AD 2020-07-01 refers to its effective date, this
AD requires using after the effective date of this AD.
    (2) The ``Alternative method of compliance (AMOCs)'' section of
ANAC AD 2020-07-01 does not apply to this AD.

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, FAA, has
the authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the Large Aircraft Section, International Validation
Branch, send it to the attention of the person identified in
paragraph (j) of this AD. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify your
appropriate principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office/
certificate holding district office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or ANAC; or ANAC's
authorized Designee. If approved by the ANAC Designee, the approval
must include the Designee's authorized signature.

(j) Related Information

    For more information about this AD, contact Krista Greer,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) Ag[ecirc]ncia Nacional de Avia[ccedil][atilde]o Civil (ANAC)
AD 2020-07-01, effective July 15, 2020.
    (ii) [Reserved]
    (3) For ANAC AD 2020-07-01, contact National Civil Aviation
Agency (ANAC), Aeronautical Products Certification Branch (GGCP),
Rua Dr. Orlando Feirabend Filho, 230--Centro Empresarial Aquarius--
Torre B--Andares 14 a 18, Parque Residencial Aquarius, CEP 12.246-
190--S[atilde]o Jos[eacute] dos Campos--SP, BRAZIL, Tel: 55 (12)
3203-6600; Email<EMAIL_ADDRESS>internet www.anac.gov.br/en/. You
may find this IBR material on the ANAC website at https://sistemas.anac.gov.br/certificacao/DA/DAE.asp.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>. This material may be found in the AD
docket on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2020-1122.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on December 7, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-27621 Filed 12-16-20; 8:45 am]
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