SUPPORTING STATEMENT
For Renewal of Information Collection Requirements under the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

40 CFR Part 8:
  Environmental Impact Assessment of Nongovernmental Activities in Antarctica

                OMB Control No. 2020-0007, EPA ICR No. 1808.10

Table of Contents
List of Acronyms	4
1.	IDENTIFICATION OF THE INFORMATION COLLECTION	5
1(a)	Title of the Information Collection	5
1(b)	Abstract	5
2.	NEED FOR AND USE OF THE COLLECTION	6
2(a)	Need/Authority for the Collection	6
2(b)	Practical Utility/Users of the Data	6
3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA	7
3(a)	Nonduplication	7
3(b)	Public Notice Requirement Regarding ICR Submission to OMB	8
3(c)	Consultations	8
3(d)	Effects of Less Frequent Collection	9
3(e)	General Guidelines	9
3(f)	Confidentiality	10
3(g)	Sensitive Questions	10
4.	THE RESPONDENTS AND THE INFORMATION REQUESTED	10
4(a)	Respondents	10
4(b)	Information Requested	11
5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT	15
5(a)	Agency Activities	15
5(b)	Collection Methodology and Management	16
5(c)	Small Entity Flexibility	16
5(d)	Collection Schedule	18
6.	ESTIMATING THE BURDEN OF THE COLLECTION	20
6(a)	Estimating Respondent Burden:	20
6(b)	Estimated Respondent Costs	24
6(b)(i) Estimating Labor Costs	24
6(b)(ii) Estimating Capital and Operations and Maintenance Costs	27
6(b)(iii) Capital/Start-up Operating and Maintenance Costs	27
6(b)(iv) Annualizing Capital Costs	27
6(c)	Estimated Agency Burden and Cost	28
6(d)	Estimating Respondent Universe and Total Burden and Costs:	33
6(e)	Bottom Line Burden Hours And Cost Tables:	36
6(e)(i) Respondent Tally	36
6(e)(ii) The Agency Tally	37
6(e)(iii) Variations in the Annual Bottom Line	37
6(f)	Reasons For Change In Burden	37
6(g)     Burden Statement	38
PART B OF THE SUPPORTING STATEMENT	39
STATISTICAL SURVEY	39

List of Acronyms

CEE			Comprehensive Environmental Evaluation
DOS			Department of State
EPA			Environmental Protection Agency
ICR			Information Collection Request
IEE			Initial Environmental Evaluation
NAICS		North American Industry Classification System
NSF			National Science Foundation
OFA			Office of Federal Activities
OMB			Office of Management and Budget
PERM			Preliminary Environmental Review Memorandum

SUPPORTING STATEMENT
For Renewal of Information Collection Requirements under the
Paperwork Reduction Act, 44 U.S.C. 3501 et seq.

40 CFR Part 8:
  Environmental Impact Assessment of Nongovernmental Activities in Antarctica

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title of the Information Collection

"Environmental Impact Assessment of Nongovernmental Activities in Antarctica" OMB Control Number 2020-0007; EPA ICR Number 1808.10.

	1(b)	Abstract

The Environmental Protection Agency's (EPA's) regulations at 40 CFR Part 8, Environmental Impact Assessment of Nongovernmental Activities in Antarctica (Rule), were promulgated pursuant to the Antarctic Science, Tourism, and Conservation Act of 1996 (Act), 16 U.S.C. 2401 et seq., as amended, 16 U.S.C. 2403a, which implements the Protocol on Environmental Protection (Protocol) to the Antarctic Treaty of 1959 (Treaty). The Rule provides for assessment of the environmental impacts of nongovernmental activities in Antarctica, including tourism, for which the United States is required to give advance notice under Paragraph 5 of Article VII of the Treaty, and for coordination of the review of information regarding environmental impact assessments received from other Parties under the Protocol. The requirements of the Rule apply to operators of nongovernmental expeditions organized in or proceeding from the territory of the United States to Antarctica and include commercial and non-commercial expeditions. Expeditions may include ship-based tours; yacht, skiing or mountaineering expeditions; privately funded research expeditions; and other nongovernmental activities. The Rule does not apply to individual U.S. citizens or groups of citizens planning to travel to Antarctica on an expedition for which they are not acting as an operator. The Rule provides nongovernmental operators with the specific requirements they need to meet in order to comply with the requirements of Article 8 and Annex I to the Protocol.  The provisions of the Rule are intended to ensure that potential environmental effects of nongovernmental activities undertaken in Antarctica are appropriately identified and considered by the operator during the planning process and that to the extent practicable, appropriate environmental safeguards which would mitigate or prevent adverse impacts on the Antarctic environment are identified by the operator.
Persons subject to the Rule must prepare environmental documentation to support the operator's determination regarding the level of environmental impact of the proposed expedition. Environmental documentation includes a Preliminary Environmental Review Memorandum (PERM), an Initial Environmental Evaluation (IEE), or a Comprehensive Environmental Evaluation (CEE). The environmental document is submitted to the Office of Federal Activities (OFA).
Environmental documents are reviewed by OFA, in consultation with the NSF and other interested Federal agencies and made available to other Parties and the public as required under the Protocol or otherwise requested. The types of nongovernmental activities currently being carried out (e.g., ship-based tours, land-based tours, flights, and privately funded research expeditions) are typically unlikely to have impacts that are more than minor or transitory, thus an IEE is the typical level of environmental documentation submitted.
This request renews the "Environmental Impact Assessment of Nongovernmental Activities in Antarctica" ICR by updating the information contained in the previously approved ICR for 40 CFR part 8. The overall respondent burden has increased from the previous ICR by 684 hours due to an adjustment change in the size of the respondent universe.
2.	NEED FOR AND USE OF THE COLLECTION

	2(a)	Need/Authority for the Collection

The basis for the Rule is the United States Code as amended:  16 U.S.C. 2401 et seq., as amended, 16 U.S.C. 2403a.
The Rule, promulgated pursuant to the Antarctic Science, Tourism, and Conservation Act of 1996, provides nongovernmental operators with the specific requirements they need to meet in order to comply with the requirements of Article 8 and Annex I to the Protocol on Environmental Protection to the Antarctic Treaty of 1959 and provides for the environmental impact assessment of nongovernmental activities, including tourism, for which the United States is required to give advance notice under paragraph 5 of Article VII of the Antarctic Treaty of 1959.
The EPA is collecting and reviewing the environmental impact assessments as part of the process of complying with the Rule and the Protocol.

	2(b)	Practical Utility/Users of the Data

OFA uses environmental impact assessment information and any associated assessment and verification information to ensure that nongovernmental operators identify and assess the potential impacts of their proposed activities, including tourism, on the Antarctic environment; that operators consider these impacts in deciding whether or how to proceed with proposed activities; and that operators provide environmental documentation pursuant to the Act and Annex I of the Protocol. OFA also makes the environmental documentation and any associated assessment and verification information available to other Parties to the Treaty and the public as required under the Protocol or as otherwise requested. OFA uses the assessment and verification information for such things as tracking Antarctic tourism trends and activities.
The purpose of the Rule is to ensure that the United States can implement its environmental impact assessment obligations for nongovernmental operators under the Protocol.  Section 8.9(b) in the Rule requires that operators have "procedures designed to provide a regular and verifiable record of the impacts of these activities." The EPA believes that this establishes a requirement that the information be available to the EPA. Otherwise, there is no way to know if an operator followed this requirement in the regulation.
3.	NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

	3(a)	Nonduplication

For both the Act and the Rule, the information submitted by a respondent does not duplicate information otherwise submitted to the government. Respondents provide an advance notification to the DOS.  This information is similar to the basic information requirements for preparation of environmental documentation under the Rule. However, the Rule ensures that nongovernmental operators identify and assess the potential impacts of their proposed activities, including tourism, on the Antarctic environment, and that operators consider these impacts in deciding whether or how to proceed with proposed activities. Operators usually include a copy of the advance notification as part of their EIA documentation. However, simply providing a copy of the advance notice submitted to the DOS as the environmental documentation would not meet the requirements of Article 8 and Annex I of the Protocol or the provisions of the Rule.

	3(b)	Public Notice Requirement Regarding ICR Submission to OMB

OFA published a Notice in the Federal Register for this ICR renewal. The notice requested public comments on the Agency's need for the information outlined in this ICR, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques.
The EPA established a public docket for this ICR renewal under Docket ID number established a public docket for this ICR renewal under Docket ID number EPA-HQ-OA-2019-0370 (past ICR renewals can be found at the older docket HQ-OECA-2007-0468). The EPA requested that any comments related to this ICR renewal be submitted to the EPA. The EPA's docket is available online at regulations.gov and through the EPA Docket Center  -  Public Reading Room, WJC West Building, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C. 20004. The public may use the public docket to obtain a copy of the ICR including the Supporting Statement, review 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.

	3(c)	Consultations

OFA reached out to the following list of potential respondents:

 Ron Naveen                                              David Rootes
Oceanites, Inc.       	                              Antarctic Logistics & Expeditions
202-237-6262<PHONE_NUMBER>

Denise Landau                                            Laura K. Smith
Denise J. Landau and Associates               Quixote Expeditions
<EMAIL_ADDRESS><EMAIL_ADDRESS><PHONE_NUMBER>

Only Ron Naveen and Denise Landau responded to EPA's consultation request. Ms. Landau suggested more hours be added to respondent burden due to the addition of safety and environmental issues to the document as well as expectations placed on respondents due to outcomes at various Antarctic meetings. Ms. Landau drafts several EIAs for several non-governmental operators. Mr. Naveen thought the hours were a bit high but his IEEs aren't as complex as he is classified as an "expedition within an expedition."

	3(d)	Effects of Less Frequent Collection

The Rule requires environmental documentation for each operator for each nongovernmental expedition to Antarctica. Nongovernmental activities are usually limited to seasonal expeditions during the austral summer season and operators report annually on their proposed expeditions. Operators with one-time only expeditions report only during the season for which their expedition is planned. In order to minimize paperwork and to implement the regulations without undue burden on operators, the Rule provides that: (1) more than one proposed expedition by an operator may be included within one environmental document; (2) one environmental document may also be used to address expeditions being carried out by more than one operator; and (3) operators may submit multi-year environmental documentation to address proposed expeditions for a period of up to five consecutive austral summer seasons.  Once environmental documentation has been prepared for a season, an operator can resubmit the same document for subsequent seasons provided the level and intensity of the activities are not unchanged and that relevant updates are submitted. Updates are likely to include dates of expeditions and changes in landing locations. The operator may also revise the document to address modifications to the expedition's activities that could have environmental consequences.  Most operators are likely to employ the multi-year provision thereby further reducing their annual reporting burden. Under this paperwork reduction provision, one environmental document may be submitted by one or more operators for proposed expeditions for a period of up to five consecutive austral summer seasons, provided that the conditions of the multi-year environmental document, including the assessment of cumulative impacts, are unchanged. The multi-year provision allows operators to update basic information and to provide information on additional activities to supplement the multi-year environmental document.
The Protocol and the Rule also require an operator to employ procedures to assess and provide a regular and verifiable record of the actual impacts of any activity which proceeds on the basis of an IEE or CEE. For activities requiring an IEE, an operator should be able to use the annual procedures currently being voluntarily utilized by operators to provide the information.

	3(e)	General Guidelines

The information collections associated with the Rule follow the guidelines of the Office of Management and Budget (OMB) in 5 CFR 1320.5(d)(2). Section III.F of the Preamble, Submission of Environmental Documents, indicates that an operator submits five copies of its environmental documentation, along with an electronic copy, if available. The EPA coordinates review of the document with other interested Federal agencies and makes electronic documents received available to the other Parties to the Treaty and the public as required under the Protocol or as otherwise requested. The EPA no longer requires an operator to provide five copies as an electronic copy is sufficient and enables EPA to distribute copies to the reviewing agencies in a timely manner. Electronic copies allow for efficient document submission and review within timing requirements prior to departure for the expedition.

	3(f)	Confidentiality

40 CFR part 8 does not require applicants to submit confidential, proprietary or trade secret information nor does the EPA anticipate that operators would submit confidential information as part of their environmental documentation.

	3(g)	Sensitive Questions

40 CFR part 8 does not require applicant response to sensitive questions (e.g., questions concerning sexuality, religious beliefs, or other matters usually considered private).

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)	Respondents

The requirements of the Rule apply to operators of nongovernmental expeditions organized in or proceeding from the territory of the United States to Antarctica for which the United States is required to give advance notice under Paragraph 5 of Article VII of the Treaty and includes commercial and non-commercial expeditions.  Expeditions include ship-based tours; yacht, skiing or mountaineering expeditions; flights; privately funded research expeditions; and other nongovernmental or nongovernment-sponsored activities. The Rule does not apply to individual U.S. citizens or groups of citizens planning to travel to Antarctica on an expedition for which they are not acting as an operator.  Further, the Act is specific for nongovernmental activities, thus governmental jurisdictions are not subject to these regulations.
Most operators are ship-based or land-based tour operators. The Standard Industrial Classification (SIC) Code for Tour Operators is 4725 and the North American Industry Classification System (NAICS) Code is 561520.
	4(b)	Information Requested

(i)  Data items, including recordkeeping requirements: The Rule provides nongovernmental operators with the specific environmental documentation requirements they need to meet in order to comply with relevant portions of the Protocol. Nongovernmental operators, including tour operators, conducting expeditions to Antarctica are required to submit environmental documentation to the EPA that evaluates the potential environmental impact of their proposed activities. The type of environmental document required depends upon the nature and intensity of the environmental impacts that could result from the activity under consideration. Under the Rule, environmental documentation includes a PERM, an IEE, or a CEE. If the operator determines that an expedition may have: (1) less than a minor or transitory impact, a PERM needs to be submitted no later than 180 days before the proposed departure to Antarctica; (2)  no more than minor or transitory impacts, including the cumulative impacts of the proposed activity in light of existing and known proposed activities, an IEE needs to be submitted no later than 90 days before the proposed departure; or (3) more than minor or transitory impacts, including the cumulative impacts of the proposed activity in light of existing and known proposed activities, a CEE needs to be submitted.
The Protocol and the Rule also require an operator to employ procedures to assess and provide a regular and verifiable record of the actual impacts of an activity which proceeds on the basis on an IEE or CEE, including monitoring of key environmental indicators for an activity proceeding on the basis of a CEE.  For activities that require an IEE, an operator should be able to use the annual procedures currently being voluntarily utilized by operators to provide the information. For activities that require a CEE, OFA would consult with the NSF and other interested Federal agencies regarding the monitoring regime that would be appropriate to the activity proposed, and with regard to possible utilization of relevant monitoring data collected by the U.S. Antarctic Program.
Environmental documentation is submitted to the EPA by an operator prior to an expedition. For most respondents, including tour operators, the EPA assumes this will be an IEE and, as provided in the Rule at Section 8.4, an operator may: (1) include more than one proposed expedition within one environmental document, and (2) one environmental document may also be used to address expeditions being carried out by more than one operator. An operator can also submit multi-year documentation to address proposed expeditions for a period of up to five consecutive austral summer seasons thus eliminating the need for annual submission of environmental documentation. The multi-year provision also allows operators to update basic information and to provide information on additional activities to supplement the multi-year environmental document. Operators are not required to retain the environmental documentation submitted to the EPA. There is nothing in the Rule, however, that precludes an operator from submitting a previous year's documentation, with appropriate updates, for a subsequent year's expedition(s) and the EPA encourages this practice.
In cases of emergency relating to the safety of human life or of ships, aircraft, equipment and facilities of high value, or the protection of the environment which requires an activity to be undertaken without completion of the documentation procedures set out in the Rule, the operator must notify the DOS within 15 days of any activities which would have otherwise required preparation of a CEE, and provide a full explanation of the activities carried out within 45 days of those activities.
Enforcement action can proceed, pursuant to Section 8.11 of the Rule, against an operator who violates any provision of the Rule.  Enforcement actions are not, however, subject to the requirements of the PRA.
(ii) Respondent Activities:  The EPA considered the definition of "burden" developed for the PRA and the OMB's final rules on implementing the PRA. For purposes of renewing this ICR, EPA estimated the hours and costs to respondents under the Rule. These are the operators (e.g., respondents) for which the United States provided advance notice under Paragraph 5 of Article VII of the Treaty for proposed nongovernmental expeditions organized in or proceeding from the U.S. to the Antarctic Treaty area. The EPA used a ship-based tour operator as its model respondent since most U.S.-based nongovernmental activities covered by the Rule are for operators and activities associated with ship-based tourism as summarized in Figure 1.
The EPA hours and cost estimates are based on the following activities which the EPA assumes a respondent would carry out to prepare and submit the environmental documentation and undertake as assessment and verification procedures.

Assumed Operator Activities Associated With:
1.  Preparing and Submitting Environmental Documentation:
 Read the regulations and evaluate business operations and the expedition(s) activities relative to the regulatory provisions of the Rule and determine the level of environmental documentation needed;
 Search reference sources for existing information on environmental conditions at proposed expedition site(s) and compile basic information from company records for use in preparation of the environmental document for the proposed expedition(s);
 Prepare the environmental impact assessment (EIA) document (e.g., PERM, IEE or CEE), or review a contractor-prepared document, and submit to EPA; and
 Revise document if necessary, or operator decides to prepare higher level EIA document, in response to the EPA's comments and submit to EPA.

2.  Post-Expedition Assessment and Verification Procedures:
 Prepare assessment and verification information.

3.  Reporting for Cases of Emergency, if necessary:
 Notify the DOS of any activities which would have otherwise required preparation of a CEE within 15 days.
 Provide a full report to the DOS within 45 days.

The Rule does NOT require or contemplate the need for respondents to:
 Acquire, install, or utilize technology and systems for the purpose of collecting, validating, and verifying information;
 Develop, acquire, install, or utilize technology and systems for the purpose of processing and maintaining information;
 Develop, acquire, install, or utilize technology and systems for the purpose of disclosing and providing information; or
 Adjust the existing ways to comply with any previously applicable instructions and requirements.

Figure 1. Numbers of Operators Submitting Environmental Documentation Under the Rule and the Level of Documentation Submitted

Season

Operators

Documentation Submitted
2017-2018
20
19 total IEEs submitted including:
     ::  12 IEEs submitted on behalf of 13 IAATO-member operators for expeditions to the Peninsula area
     ::  1 IEE submitted by one IAATO-member operator for its expeditions to the Continental area
     ::  6 IEEs submitted by non-IAATO operators
2018-2019
23
22 total IEEs submitted including:
     ::  14 IEEs submitted on behalf of 15 IAATO-member operators for expeditions to the Peninsula area
     ::  1 IEE submitted by one IAATO-member operator for its expeditions to the Continental area
     ::  IEEs submitted by non-IAATO operators
2019-2020

23 total IEEs submitted including:
     ::  15 IEEs submitted on behalf of 15 IAATO-member operators for expeditions to the Peninsula area
     ::  1 IEE submitted by one IAATO-member operator for its expeditions to the Continental area
     :: 7 IEEs submitted by non-IAATO operators
2020-2021

8 total IEEs submitted including:
     ::  7 IEEs submitted on behalf of 7 IAATO-member operators for expeditions to the Peninsula area
     ::  1 IEEs submitted by non-IAATO operators
2021-2022

21 total IEEs submitted including:
     ::  14 IEEs submitted on behalf of 14 IAATO-member operators for expeditions to the Peninsula area
     ::  1 IEE submitted by one IAATO-member operator for its expeditions to the Continental area
     :: 6 IEEs submitted by non-IAATO operators

5.	THE INFORMATION COLLECTED -- AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT

	5(a)	Agency Activities

The EPA consults with the DOS, the NSF, and other interested Federal agencies for activities associated with the Rule. This enables appropriate government agencies with specific Antarctic interests and expertise to be involved with the review of the environmental documentation for proposed nongovernmental expeditions including coordination of appropriate information relative to the U.S. Antarctic Program. Further, violation of the provisions of the Rule could result in enforcement and penalties pursuant to the Antarctic Conservation Act, as amended, as undertaken by the NSF and/or the DOJ. Activities associated with the Rule for the EPA and other Federal agencies consist of the following.
The EPA and Other Federal Agencies Activities Associated With:
1.  Processing and Reviewing Environmental Documentation Received from Operators, 2.  Processing and Reviewing Post-Expedition Assessment and Verification Information, 3.  Processing and Reviewing Reports for Cases of Emergency, and 4.  Processing and Reviewing Environmental Documentation Received from Other Parties:

	5(b)	Collection Methodology and Management

The environmental documentation that is required by the Rule is submitted by operators in accordance with the deadlines in the regulations. These documents can also be submitted electronically. The Rule mandates specific information to be included in the document but does not require a specific format. Since the information requirement is the same as that in the Protocol, this allows flexibility for operators who have multiple international documentation requirements. The EPA, in consultation with other interested Federal agencies, reviews the environmental documentation relative to the general requirements (e.g., Rule, Section 8.4) and the specific requirements for each level of documentation (e.g., Rule, Section 8.6 for PERMs; Section 8.7 for IEEs; and Section 8.8 for CEEs). The EPA provides its comments to the operator, and the operator then prepares revised documentation or responses to the EPA's questions or comments. Following the final response from the operator, if appropriate, the EPA, with the concurrence of the NSF, makes a finding that the documentation submitted does meet the requirements of Article 8 and Annex I of the Protocol and the provisions of the regulations.  The EPA provides copies of environmental documents to all interested Federal agencies, and the public is informed of receipt of environmental documents through the Receipt of Environmental Impact Assessments (EIAs) Regarding Nongovernmental Activities in Antarctica page on EPA's website, and through the Federal Register for CEEs.
The EPA maintains file records for each action.

      5(c)	Small Entity Flexibility

For purposes of assessing the impacts of the information collection and the Rule on small entities, small entity is defined as:
(1) a small business as defined by the Small Business Administration with the North American Industry Classification System (NAICS) code for "Tour Operators," code 561520, with annual maximum receipts of $5.0 million (13 CFR Part 121); and
(2) a small organization that is any not-for-profit enterprise which is independently owned and operated and is not dominant in its field.

The EPA believes that because the information collection and the Rule only requires assessment of environmental impacts the effects on any small entities will be limited primarily to the cost of preparing such an analysis and that the requirements are no greater than necessary to ensure that the United States will be in compliance with its international obligations under the Protocol and the Treaty. The costs are minimal because the types of activities currently being carried out typically are unlikely to have impacts that are more than minor or transitory assuming that activities will be carried out in accordance with the guidelines set forth in the ATCM Recommendation XVIII-1, Tourism and Non-Governmental Activities, the relevant provisions of other U.S. statutes, and Annexes II-V to the Protocol. Therefore, most activities are likely to need only IEE documentation, the cost of which is minimal as shown in Section 6 of this Supporting Statement and as presented in the Preamble to the Rule, Section V.D, Paperwork Reduction Act. Further, the EPA has included provisions in the Rule which are available to all respondents, including small entities, which will have a positive effect by minimizing the cost, and reducing the paperwork burden, of such an analysis.
It has been the EPA's experience that respondents used the cost reduction provisions in the final regulations. The cost and paperwork reduction provisions in the Rule include: (1) more than one proposed expedition by an operator may be included within one environmental document and may, if appropriate, include a single discussion of components of the environmental analysis which are applicable to some or all of the proposed expeditions; (2) one environmental document may also be used to address expeditions being carried out by more than one operator, provided that the environmental documentation includes the names of each operator for which the environmental documentation is being submitted pursuant to obligations under these regulations; and (3 one environmental document may be submitted by one or more operators for proposed expeditions for a period of up to five consecutive austral summer seasons, provided that the conditions of the multi-year environmental document, including the assessment of cumulative impacts, are unchanged.  The multi-year provision also allows operators to update basic information and to provide information on additional activities to supplement the multi-year environmental document without having to revise and re-submit the entire document.
In consideration of the timing requirements associated with the need to assist new operators who are unfamiliar with the regulations and its schedules, or to assist operators who have unanticipated amendments to their EIA documentation for a particular year, the Rule at Section 8.5(b) provides that the EPA may waive or modify the deadlines of the Rule if the EPA determines that an operator is acting in good faith and that circumstances outside the control of the operator created delays, provided that environmental documentation fully meets deadlines under the Protocol.
The Rule does not provide an exemption from coverage of the collection of information, or any part thereof. This is because the Rule only requires assessment of environmental impacts.  This assessment is limited to the cost of preparing such an analysis and the requirements would be no greater than necessary to ensure that the United States will be in compliance with its international obligations under the Protocol and the Treaty.

	5(d)	Collection Schedule

The schedule for submittal of environmental documentation depends on the document to be submitted as described below. An operator could submit environmental documentation prior to these deadlines. In all cases, however, documents need to be submitted such that the schedule requirements for submitting draft CEEs to the Parties can be met by the United States.
Preliminary Environmental Review Memorandum (PERM):  In accordance with the Rule at Section 8.6, a PERM needs to be submitted to EPA no less than 180 days before the proposed departure of the expedition.
::   The EPA, in consultation with other interested Federal agencies, provides its comments to the operator within 15 days of receipt.
::   The operator then has 75 days to revise the PERM or prepare an IEE, if necessary.  If an IEE is prepared and submitted within the 75-day response period, it is reviewed under the time frames for an IEE (see below).  If a CEE is prepared, it is reviewed under the time frames for a CEE (see below.)
::   Within 30 days, if appropriate, the EPA, with the concurrence of the NSF, provides notice to the operator that the environmental documentation does not meet the requirements of the Protocol and the provisions of the Rule.
Initial Environmental Evaluation (IEE):  In accordance with the Rule at Section 8.7, an IEE needs to be submitted no fewer than 90 days before the proposed departure of the expedition.
::   The EPA, in consultation with other interested Federal agencies, provides its comments to the operator within 30 days of receipt.
::   The operator then has 45 days to revise the IEE or prepare a CEE, if necessary.  If a CEE is prepared, it would be reviewed under the time frames for a CEE (see below).
::   Within 15 days of receiving the final IEE from the operator or, if the operator does not provide a final IEE, within 60 days following the EPA's comments on the original IEE, if appropriate, EPA, with the concurrence of the NSF, provides notice to the operator that the environmental documentation does not meet the requirements of the Protocol and the provisions of the Final Rule.
Comprehensive Environmental Evaluation (CEE):  In accordance with the Final Rule at Section 8.8(b), operators need to submit a CEE.
::   Within 15 days of receipt, the EPA would: (1) send it to the Department of State for circulation to the Parties and Committee for Environmental Protection; and (2) publish notice of receipt and request for comments in the Federal Register.
::   The EPA accepts public comments for 90 days following the published notice.
::   The EPA, in consultation with other interested Federal agencies, provides its comments to the operator within 120 days following the Federal Register notice.
::   The operator then needs to submit a final CEE 75 days before commencement of the proposed activity in the Antarctic Treaty area.
::   Within 15 days of receiving the final CEE from the operator or, if the operator does not provide a final CEE, within 60 days prior to departure of the expedition, if appropriate, the EPA, with the concurrence of the NSF, provides notice to the operator that the environmental documentation does not meet the requirements of the Protocol and the provisions of the Final Rule.
::   If the EPA does not provide such notice, the operator would have met all requirements provided that procedures, which may include appropriate monitoring, are put in place to assess and verify the impact of the activity.
::   No later than 60 days before commencement of the proposed activity in the Antarctic Treaty area, the EPA: (1) transmits the CEE, along with notice of any decisions by the operator, to the Department of State for circulation to the Parties, and (2) publishes notice of availability of the final CEE in the Federal Register.
Information to Assess and Verify Impacts:  There is no set schedule requirements in the Final Rule for submitting information on measures to assess and verify environmental impacts.  Operators provide the information to the NSF on a voluntary basis. Operators often specify this schedule within the environmental document for the expedition.
Reporting for Cases of Emergency:  In accordance with the Final Rule at Section 8.10, within 15 days in cases of emergency, an operator needs to report notice of any activities which would have otherwise required preparation of a CEE to the Department of State, and a full explanation of the activities carried out must be provided within 45 days of those activities.
6.	ESTIMATING THE BURDEN OF THE COLLECTION

	6(a)	Estimating Respondent Burden:
The estimated respondent (e.g., operator) hours and cost for the three possible levels of environmental documentation (e.g., PERM, IEE, CEE) and associated post-expedition assessment and verification procedures are described below. Each type of environmental documentation should increase in effort as the level of complexity increases for the type of environmental documentation required, e.g., from PERM to IEE to CEE and the estimate is based on the EPA's experience for the twenty-five austral summer seasons the Rule has been in effect and considers the paperwork reduction options utilized by the operators.

The model respondent used in the estimates is a nongovernmental, U.S.-based Antarctic tour ship operator. The estimated hours and cost for operators is based on the assumption that most environmental documentation submitted by operators will be IEEs. As stated in the Preamble to the Final Rule (Section III.D.3(b)), at a minimum, an IEE is typically the appropriate level of environmental documentation for proposed activities.  The types of nongovernmental activities that are currently being carried out typically are unlikely to have impacts that are more than minor or transitory assuming that activities are carried out in accordance with the guidelines set forth in the ATCM, Recommendation XVIII-1, Tourism and Non-Governmental Activities, the relevant provisions of other U.S. statutes, and Annexes II-V to the Protocol. During the austral summer seasons the Rule has been in effect, IEEs have been submitted by operators as summarized in Figure 1. The following elements further discuss the assumptions factored into the estimated respondent hours and cost.
	1.	PERM Model for Respondent Submittals: For PERMs, the estimated hours and cost is based on the estimated time to comply with the Final Rule at Section 8.4, preparation of environmental documents, generally, and Section 8.6, preliminary environmental review.  The estimate assumes one week at 40 hours per week including revisions in response to any the EPA comments. Assessment and verification procedures are not required at the PERM level of activity and documentation. EPA anticipates one respondent per year for purposes of the cost calculations in Exhibit 1A. In fact, during the twenty-five austral summer seasons the Rule has been in effect, only three PERMs have been submitted as the final document for an expedition.

2.	IEE Model for Respondent Submittals: The EPA has developed three models for IEEs that incorporate the estimated time to comply with the Final Rule at Section 8.4, preparation of environmental documents, generally, and Section 8.7, initial environmental evaluation. The model also considers the experience with IEE documents received during the ten austral summer seasons the Rule has been in effect and burden estimates in the previous Supporting Statements for the ICRs for the Interim Final and Final Rules. The assumptions for the EPA's IEE model include the following:

::   Figure 2 lists the potential respondents.
::   The maximum length for an IEE is about 200 pages including supplemental information.
::   IEEs consist of "core" information with supplemental expedition-specific or other project-specific information (e.g., dates, landing sites, number of tours, etc.) attached or referenced.
::   For initial preparation of the "core" IEE, the estimate assumes five weeks, on average, at 40 hours/week, or about 200 hours, including revisions in response to EPA comments.  This estimate assumes a full-time effort during the four weeks, and that information will be incorporated by reference when appropriate.
::   The estimate assumes 25 hours for an operator to prepare and/or compile supplemental information.
::   If appropriate, EPA anticipates operators will submit the "core" IEE in subsequent years with any necessary revisions (discussed below).  An estimated two weeks at 40 hours/week is estimated to prepare this "revised" IEE for submittal in subsequent years.  The estimate of 25 hours for preparation and/or compilation of supplemental information remains the same.
::   If appropriate, the EPA anticipates operators will submit "multi-year" IEE documentation. In the initial year, this is anticipated to consist of a "revised" IEE with an estimated 50 hours associated preparation time and 25hours for preparation and/or compilation of supplemental information. For the subsequent four consecutive years the multi-year "IEE can be submitted by an operator, for purposes of maximum burden estimation, 25 hours are estimated for preparation and/or compilation of the supplemental information.
::   The IEE level of documentation requires assessment and verification (A/V) procedures; 15 hours are estimated for preparation and/or compilation of this information.

IEE Model 1 - Core IEE:  The EPA anticipates six one-time core IEEs will be prepared for the three austral summer seasons this ICR renewal will be in effect.  The operator hourly burden for preparation of a Core IEE is estimated as follows:

Prepare "core" IEE: 				200 hours/IEE x 6 IEEs 		=   1200 hours
Prepare supplemental information:		25 hours/operator x 6 operators	=   150hours
A/V procedures:				15 hours/operator x 6 operators 	=   90 hours
TOTAL HOURS									=   1440 hours
TOTAL HOURS PER IEE (6 IEEs)							=   240 hours
TOTAL HOURS PER OPERATOR (6 operators)					=   240 hours

IEE Model 2 - Revised IEE:  For purposes of maximum burden assessment, the EPA anticipates that eight returning operators will continue to submit revised IEEs for the three austral summer seasons this ICR will be in effect. Updates are likely to include such items as dates of expeditions and changes in landing locations. Revisions could address items such as assessment of the potential impacts, including cumulative impacts, of modifications to the planned activities and any associated mitigation measures, or a reassessment of overall impacts for the expedition. Thus, for subsequent seasons, the EPA assumes a reduced number of hours would be required for revision of the "core" IEE, and the hours for preparation of supplemental information will remain the same. The model for estimating respondent hourly burden for a Revised IEE is based on the EPA's experience for the twenty-five austral summer seasons the Rule has been in effect and considers the paperwork reduction options utilized by the operators. The operator hourly burden for preparation of a Revised IEE is estimated as follows:

Prepare "Revised" IEE:			50 hours/IEE x 8 IEEs 		= 400 hours
Prepare supplemental information:		25 hours/operator x 8 operators	= 200 hours

A/V procedures:				15 hours/operator x 8 operators	= 120 hours
TOTAL HOURS									= 720 hours
TOTAL HOURS PER IEE (8 IEEs)							= 90 hours
TOTAL HOURS PER OPERATOR (8 operators)					= 90 hours

Model 3 - Multi-Year IEE: Under the Final Rule, operators may choose to submit multi-year IEE documentation. Under this model, the EPA assumes the operators will submit a Revised IEE in the initial year. The multi-year provision then allows operators to supplement the multi-year environmental document without having to revise and re-submit the entire document in order to update basic information as necessary, and to provide information on any new activities or revisions to the documented activities. However, many operators find it easier to revise and re-submit the entire document as necessary.

Initial Year:
Prepare Revised IEE			50 hours/IEE x 15 IEEs 			= 750 hours
A/V procedures: 			15 hours/operator x 15 ops x 1 year 		= 225 hours

Four Subsequent Years for a Total of Five Consecutive Years:
Prepare supplemental information:	25 hours/operator x 15 ops x 4 years 		= 1,500 hours

A/V procedures:			15hours/operator x 15 ops x 4 years 		= 600 hours
TOTAL HOURS for 5-Year Period of Multi-Year IEE				= 3075 hours
TOTAL HOURS PER YEAR								= 615 hours
TOTAL HOURS PER YEAR (5 Years) PER OPERATOR (15 operators)		= 41 hours

3.	CEE Model for Respondent Submittals: For CEEs, the estimated hours and cost is based on the estimated time to comply with the Final Rule at Section 8.4, preparation of environmental documents, generally, and Section 8.8, comprehensive environmental evaluation, and assumes an increased effort from that required for an IEE. The estimate assumes six weeks at 40 hours per week, or 240 hours, including time for revisions in response to EPA's comments. The estimate assumes 60 hours to prepare assessment and verification information associated with the CEE level of activity and documentation. No CEEs have been submitted during the twenty-two austral summer seasons the Rule has been in effect.  However, EPA is estimating one respondent per year in the cost calculations to allow for the potential that some unanticipated activities may meet the CEE requirements.
4.	Emergency Reporting Model: Reporting for Cases of Emergency is based on the Final Rule at Section 8.10, Cases of emergency, which requires notice and reporting for activities taken in cases of emergency which would have otherwise required the preparation of a CEE. The estimate is based on reporting requirements only, not the actual cost of the emergency response action. No emergency reporting incidents occuring during the twenty-five austral summer seasons the Rule has been in effect. However, EPA has assumed one emergency reported per 10 years in the hours and cost estimate to allow for the potential for consideration if needed.

	6(b)	Estimated Respondent Costs

      6(b)(i) Estimating Labor Costs

The cost estimates are based on industry labor rates obtained during informal consultations with industry representatives and include overhead and fringe benefits.  The three rates used in the calculations represent the rates provided by the industry representatives including $85/hour as a low, $95/hour as an intermediate, and $105/hour as a high.  The $95/hour intermediate rate is used for summary purposes.
The EPA estimated wage for grant and permit applicants is as follows:
 Operator Wage Rate:  $95 per hour

Figures 2, 3, 4, 5, and 6 present the estimated Respondent labor cost for drafting the three possible levels of environmental documentation (e.g., PERM, IEE, CEE) and associated post-expedition assessment and verification information.

FIGURE 2.  Respondent Labor Costs for PERM Model

Hours
Rate Per Hour
Total Costs
High
40
$105
$ 4000
Medium
40
$ 95
$ 3000
Low
40
$ 85
$ 2609

FIGURE 3.  Respondent Labor Costs for IEE "Core" Model

Hours
Rate Per Hour
Total Costs
High
240
$105
$ 25,000
Medium
240
$ 95
$ 22,800
Low
240
$ 85
$ 20,400

FIGURE 4.  Respondent Labor Costs for "Revised" IEE Model

Hours
Rate Per Hour
Total Costs
High
90
$105
$ 9,450
Medium
90
$ 95
$ 8,550
Low
90
$ 85
$ 7,650

FIGURE 5.  Respondent Labor Costs for "Subsequent Years" IEE Model

Hours
Rate Per Hour
Total Costs
High
41
$105
$ 4,305
Medium
41
$ 95
$ 3,895
Low
41
$ 85
$ 3,485

FIGURE 6.  Respondent Labor Costs for CEE Model

Hours
Rate Per Hour
Total Costs
High
300
$105
$ 31,500
Medium
300
$ 95
$ 28,500
Low
300
$ 85
$ 22,500

      6(b)(ii) Estimating Capital and Operations and Maintenance Costs

1.         Capital/Start Up Costs: The EPA does not anticipate any capital or startup costs on the part of respondents to comply with the provisions of the Final Rule.

2.	O&M Costs:  The EPA does not anticipate any operating and maintenance (O&M) costs associated with the paperwork requirements for respondents to comply with the provisions of the Final Rule.

      6(b)(iii) Capital/Start-up Operating and Maintenance Costs
There are no capital costs and there are no operating and maintenance costs required.

      6(b)(iv) Annualizing Capital Costs
The EPA does not anticipate any capital or start up costs on the part of respondents to comply with the provisions of the Final Rule. Therefore, there is no need to annualize capital costs if there is not any capital or start up costs.

6(c)	Estimated Agency Burden and Cost

The estimated Federal government hours and cost for processing and reviewing the three possible levels of environmental documentation (e.g., PERM, IEE, CEE) are described below. The effort should increase as an increasing level of environmental documentation is required; e.g., from PERM to IEE to CEE. As with the respondents, the model used for the Federal government estimates is a nongovernmental, U.S.-based ship-based tour operator, and the estimated hours and cost for the Federal government is based on the assumption that most environmental documentation submitted by operators will be IEEs.
 The EPA Wage Rate: $78.28 per hour

3.	PERM Model for Review of Submissions: The hourly burden for Federal government review of a PERM is estimated to be 25% of the respondent's time to prepare a PERM, or 10 hours, plus an additional 2 hours for administrative activities. Assessment and verification procedures are not required at the PERM level of activity and documentation. The EPA anticipates that only one respondent per year will submit a PERM. In fact, only three PERMs have been submitted as the final documentation for expeditions during the twenty-two austral summer seasons the Rule has been in effect.

4.	IEE Model for Review of Submissions:  Operators can choose to submit a Core or Revised or a Multi-Year IEE as discussed for the respondents in Section 6(a). Under the Multi-Year IEE model, EPA assumes the operators, as applicable, would submit a Revised IEE in the initial year and, for purposes of maximum burden estimation, supplemental information for the subsequent four years. Over the next three years, all Multi-Year IEE submissions will follow the Multi-Year Model with a revised submission one year and two subsequent years where only the submission is updated.  The EPA assumes fifteen operators will submit fifteen multi-year IEEs. The EPA has developed a model for Federal government review of the three models for IEEs.  A detailed discussion of the "Model for Federal Government Review of IEEs" is presented Section 6(c).

5.	CEE Model for Review of Submissions:  The hourly burden for Federal government review of a CEE is estimated to be 50% of the respondent's time to prepare a CEE, or 120 hours, plus an additional 15 hours for administrative activities. The hourly burden for review of assessment and verification information is estimated to be 50% of the respondent's time to prepare the assessment and verification information, or 30 hours. Although one respondent per year is estimated for purposes of the cost calculations in Exhibit 2C, EPA anticipates that the actual number of nongovernmental expeditions with activities that will likely proceed with more than minor or transitory impacts may well be reduced to less than one respondent per year. In fact, there were no CEEs submitted during the twenty-five austral summer seasons the Rule has been in effect.

6.	Reviewing Emergency Reports: Reporting for Cases of Emergency is based on the Final Rule at Section 8.10, Cases of Emergency, which would require operator notice and reporting for activities taken in cases of emergency which would have otherwise required the preparation of a CEE. The estimated hourly burden for Federal government review of an Emergency Report is estimated to be 50% of the respondent's time to prepare a CEE, or 120 hours, and 50% of the respondent's time to prepare the assessment and verification information for an emergency, or 30 hours, for review of this information. An additional 15 hours are assumed for notifying the Parties and for administrative activities. As with the respondents, the Federal government hours and cost estimate assumes one such emergency per 10 years.

7.	Capital/Start Up Costs: The EPA does not anticipate any capital or start up costs on the part of the Federal government to comply with the provisions of the Final Rule.

8.	O&M Costs:  The EPA does not anticipate any operating and maintenance (O&M) on the part of the Federal government.

As noted in the assumptions above for both the respondents and the Federal government, EPA assumes that most environmental documentation submitted under the Final Rule will be IEEs.  EPA has developed a model for Federal government review of IEEs based on three types of IEE documentation: (1) "Core" IEE, (2) "Revised" IEE, and (3) "Multi-Year" IEE.

The calculations include the estimated technical review time for the three IEE models and the estimated technical hours per Federal review.

 	1.  Estimated Hours for Technical Review of an IEE:  This estimate includes the following assumptions consistent with those in the respondents' estimated burden (Section 6(a)) and consideration of the experience under the twenty-two austral summer seasons the Rule has been in effect:
::  Section 6(a), including Figure 2, lists the potential respondents.
::  The maximum length for an IEE is about 200 pages including supplemental information.
::  An IEE consists of "core" information with supplemental expedition-specific (e.g., dates, landing sites, number of tours, etc.) or other project-specific information attached or referenced.
::  The core information requires a "Core IEE" review and a "Core IEE" review is estimated to be 50% of the respondent's time to prepare a "core" IEE, or 80 hours.
::  The time to review a "Revised IEE" is estimated to be 25% of the respondent's time to prepare a "core" IEE, or 40 hours.
::  Operators may employ the multi-year provision whereby multi-year IEE documentation will be submitted. The multi-year provision also allows operators to update basic information and to provide information on additional activities to supplement the multi-year environmental document. Review of the initial multi-year document is assumed to be the same as review of a Revised IEE, e.g., 40 hours for the Revised IEE. For the subsequent four years, the annual advance notice and confirmation that the conditions of the multi-year document are unchanged is estimated to take 20 hours per IEE.
::  The IEE level of documentation requires assessment and verification (A/V) procedures. The hourly burden for review of A/V information is estimated 1 hour per information package.
:: For an IEE that covers multiple operators, the hours and costs per operator for reviews are spread among the total number of operators; e.g., the more operators under one document, the lower the hours and costs for each review on a per operator basis.

IEE Model 1 - Core IEE:  The EPA anticipates five one-time core IEEs will be prepared annually for the three austral summer seasons this ICR renewal will be in effect. The Federal government hourly burden for preparation of a Core IEE is estimated as follows:

Review "core" IEE			80 hrs/IEE x 6 IEEs			= 480 hours
Review of A/V information		1 hrs/A/V pkg x 6 operators		= 6 hours
TOTAL HOURS								= 486 hours
TOTAL HOURS PER IEE (6 IEEs)                                        		=  81 hours
TOTAL HOURS PER OPERATOR (6 operators)                 		= 81 hours

IEE Model 2 - Revised IEE:  For purposes of maximum burden assessment, the EPA assumes that eight present operators will remain the same, and that these operators will continue to submit revised IEEs annually for the three austral summer seasons this ICR will be in effect. and any associated mitigation measures, or a reassessment of overall impacts for the expedition. Thus, for subsequent seasons, the EPA estimates the government review time to be 25% of the respondent's time to prepare a "core" IEE, or 40 hours, and the hours for review of supplemental information will remain the same. The operator hourly burden for preparation of a "Revised" IEE is estimated as follows:

Review "revised" IEE                       40 hours/IEE x8 IEEs			= 320 hours
Review of A/V information              1 hours/A/V pkg x 8 operators 	= 8 hours
TOTAL HOURS	                                                                               = 328 hours
TOTAL HOURS PER IEE (5 IEEs)                                                    	= 41 hours
TOTAL HOURS PER OPERATOR (5 operators)                 		=   41 hours

Model 3 - Multi-Year IEE: Under the Final Rule, operators may also choose to submit multi-year IEE documentation. Under this model, the EPA assumes the operators will submit a Revised IEE in the initial year. The multi-year provision then allows operators to supplement the multi-year environmental document in order to update basis information as necessary, and to provide information on any new activities or revisions to the documented activities.

EPA assumes fifteen operators may submit "multi-year" IEEs, and the Federal government hourly burden for review of the "Multi-Year" IEE will require review at the Revised IEE level of review (e.g., 40 hours) and 1 hour for A/V information. In subsequent years, for purposes of maximum burden estimation, 20 hours per IEE is estimated for review of supplemental information and 1 hour for A/V information. The Federal government hourly burden is estimated as follows for review of "Multi-Year" IEEs:

Initial Year:
Review Revised IEE:		 	40 hours/IEE x 15 IEEs x 1 yr		=   600 hours
Review A/V information:		1 hour/operator x 15 ops x 1 year		=   15 hours

Four Subsequent Years for a Total of Five Consecutive Years:
Review supplemental information:	20 hour/operator x 15 ops x 4 years		= 1200 hours
Review A/V information: 		1 hour/operator x 15 ops x 4 years		= 60 hours
TOTAL HOURS for 5-Year Period of Multi-Year IEE				= 1,875 hours
TOTAL HOURS PER YEAR (5 Years) PER IEE 15 IEEs)				=  25 hours
TOTAL HOURS PER YEAR (5 Years) PER OPERATOR (15 operators)		= 25 hours

2.  Estimated Technical Hours by Federal Agency for Review of an IEE:  . Based on experience during the twenty-five austral summer seasons the Rule has been in effect and the anticipated consultation needs under the Final Rule, the following calculations the 81 total hours per "Core" IEE review, the 41 total hours per "Revised" IEE review, and the 25 total hours per "Subsequent Year, Multi-Year" IEE.
The model further assumes that 2/3 of the time for review of each document applies to the draft IEE, and 1/3 of the time to the final IEE:

Core IEEs

Revised IEE

Subsequent Years,
Multi-Year IEE

Review Hours per Draft

53

27

17

Review Hours per Final

28

14

8

Total Hours

81

41

25

6(d)	Estimating Respondent Universe and Total Burden and Costs:
Number of Respondents: Based on the EPA's experience during the twenty-five austral summer seasons the Rule has been in effect (see Figure 1), for purposes of this ICR renewal, the total number of respondents is estimated as twenty-eight as delineated in Figure 7. This estimate includes 23 repeat operators who are expected to submit or revised or multi-year IEE documentation, and five new operators who are expected to submit new IEEs.

FIGURE 7.	Estimated Respondents and Anticipated Level of EIA Documentation Considering EPA's Experience Under the Rule

Operators						Number of Operators
U.S.-based IAATO-member tour operators                                       16 Peninsular Area
U.S.-based IAATO-member tour operators                            	1 Ross Sea Area
U.S.-based IAATO-member tour operators	                                    1 Continental Area
U.S.-based non-IAATO member tour operators                                2 Peninsula Area
U.S.-based privately funded researcher                                              3
U.S.-based possible new respondents                                                6
TOTAL ESTIMATED                                                                      29

Based on the reporting by operators for the twenty-five austral summer seasons during the time the Rule has been in effect under an OMB-approved ICR and the EPA's understanding of the types of nongovernmental activities likely to continue to be undertaken by U.S.-based operators in Antarctica, the EPA anticipates that the most likely scenario during the three-year renewal period this information collection will be in effect consists of the following:
:: Twenty-nine operators will likely plan expeditions to Antarctica and will submit environmental documentation including assessment and verification information.  Twenty-three will likely be repeat operators with annual expeditions, and three operators may submit new documentation.
  Six operators may be new operators planning annual expeditions and operators of one-time only expeditions.
   Eight of the 23 repeat operators with annual expeditions will submit revised IEEs.
:: It was assumed that 15 of the 23 repeat operators would submit new Multi-Year IEEs, including a "Revised" IEE in the initial year and "Subsequent Year, Multi-Year" IEE documentation for the two subsequent years.
::  No CEEs have been submitted as the final documentation during the past twenty-two austral seasons and only three PERMs have been submitted during this time-frame. No CEEs are anticipated during the effective period for this ICR renewal.
::  There were no emergencies requiring emergency reporting during the twenty-two austral summer seasons the Rule has been in effect, and none are expected to occur during the effective period for this ICR renewal.
::  Other than receipt of the annual list of IEEs, there is no way to anticipate receipt of environmental documents from the Parties on an annual basis or during the effective period for this ICR renewal. There is no burden to the respondents associated with receipt of documents from the Parties. Therefore, there are no burden estimates associated with coordinating review of information received from other Parties included in the burden summary.

The estimated hours and costs for the respondents and the Federal government for the 3-year period of this ICR renewal assumes 29 operators per year with 6 new operators and 23 repeat operators each year. For the 23 repeat operators, the assumptions are that eight will prepare "Revised" IEEs and 15 will prepare "Multi-Year" IEEs.
The estimated 29 operators submitting environmental documentation under the Final Rule during this ICR renewal period, the annual total hours for the 29 operators are estimated to be 2,988 hours, and the annual total hourly burden per operator is estimated to be 103 hours.  These annual totals reflect submission of different levels of documentation by the 29 operators.  The estimated annual average time per respondent ranges from 41 to 240 hours depending on the level of environmental documentation and the paperwork reduction provisions employed by the respondent.
For the estimated 29 operators submitting environmental documentation under the Final Rule during this ICR renewal period, the annual total cost for the 29 operators is estimated to be $283,860 and the annual total cost burden per operator is estimated to be $9,788. These annual totals reflect submission of different levels of documentation by the 29 operators. The estimated annual average per respondent ranges from $3,895 to $22,800 depending on the level of environmental documentation and the paperwork reduction provisions employed by the respondent.
The estimated 29 operators submitting environmental documentation under the Final Rule during this ICR renewal period, the annual total hours and cost for the Federal government is estimated as 1,296 hours and $101,451. The annual total hours and cost per operator for the Federal government is estimated as 45 hours and $3,498. These annual totals reflect submission of different levels of documentation by the 29 operators. The estimated annual average hours and cost per respondent ranges from 25 hours and $1,957 to 81 hours and $6,341 depending on the level of environmental documentation and the paperwork reduction provisions employed by the respondent.

6(e)	Bottom Line Burden Hours And Cost Tables:

6(e)(i) Respondent Tally

               TOTAL ESTIMATED RESPONDENT BURDEN AND COST SUMMARY

Number of Respondents
Total Hours Per Year
Total Labor Cost Per Year
Total Annual O&M Costs
"Core"
6
1440
$136,800
$0
"Revised"
8
720
$68,400
$0
"Multi-Year"
15
615
$58,425
$0
PERM, CEE, and ER
-
213
$20,235
$0
Total
29
2,988
$283,860
$0

6(e)(ii) The Agency Tally

TOTAL ESTIMATED AGENCY BURDEN AND COST SUMMARY

Number of Respondents
Total Hours Per Year
Total Labor Cost Per Year
Total Annual O&M Costs
"Core"
6
486
$38,044
$0
"Revised"
8
328
$25,676
$0
"Multi-Year"
15
375
$29,355
$0
PERM, CEE, and ER
-
107
$8,376
$0
Total
29
1,296
$101,451
$ 0

6(e)(iii) Variations in the Annual Bottom Line

There is no anticipation of significant variation (>25%) in the annual respondent reporting/recordkeeping burden or cost over the course of the clearance period request.

6(f)	Reasons for Change In Burden

The current inventory approved by the OMB for the annual reporting and recordkeeping hourly burden is 1,544 hours. The total 3-year estimated hourly burden of 8,964 hours for the anticipated 29 operators represents an annual reporting and recordkeeping hourly burden of 2,988 hours, or 103 hours per operator for this 3-year renewal period. This increased adjustment to the annual reporting and recordkeeping hourly burden is 1,444 hours. This increased adjustment is the result of an anticipated increase in the number of respondent universe, the result of the inclusion of more complex information regarding safety and environmental issues, more diverse tourist activities and outcomes from current Antarctic Treaty Consultative meetings, and the accounting of a potential PERM, CEE and Emergency Report submitted by any of the 29 anticipated operators (every three years).

  6(g)     Burden Statement
The annual public reporting and recordkeeping burden for this collection of information is estimated to average 2,988 hours annually, or 103 hours per response. This hourly burden reflects annual submission of different levels of environmental documentation by an anticipated 29 respondents (e.g., U.S.-based nongovernmental operators). 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; 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. The OMB control numbers for the EPA's regulations are listed in 40 CFR part 9 and 48 CFR chapter 15.

To comment on the Agency'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, the EPA has established a public docket for this ICR under [EPA- OA-2019-0370] formerly [EPA-HQ-OECA-2007-0468], which is available for online viewing at www.regulations.gov, or in person viewing at the Docket and Information Center  in the EPA Docket Center (EPA/DC), William Jefferson Clinton West, Room 3334, 1301 Constitution Ave., NW, Washington, DC.  The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Enforcement and Compliance Docket and Information Center is<PHONE_NUMBER>.  An electronic version of the public docket is available at www.regulations.gov. This site can be used 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. When in the system, select "search," then key in the docket ID number identified above.

PART B OF THE SUPPORTING STATEMENT
	STATISTICAL SURVEY

This collection of information does not use or is otherwise based on a statistical survey.


[Federal Register Volume 87, Number 187 (Wednesday, September 28, 2022)]
[Notices]
[Pages 58810-58812]
[FR Doc No: 2022-20993]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-D-6569]

Clinical Decision Support Software; Guidance for Industry and
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Clinical Decision
Support Software.'' This final guidance provides clarity on FDA's
oversight of clinical decision support (CDS) software intended for
health care professionals with the purpose of describing FDA's
regulatory approach to CDS software functions. This guidance clarifies
the types of CDS functions that do not meet the definition of a device
as amended by the 21st Century Cures Act (Cures Act).

DATES: The announcement of the guidance is published in the Federal
Register on September 28, 2022.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
[FDA-2017-D-6569] for ``Clinical Decision Support Software; Guidance
for Industry and Food and Drug Administration Staff.'' Received
comments will be placed in the docket and, except for those submitted
as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Clinical Decision Support Software; Guidance for Industry and Food
and Drug Administration Staff'' to the Office of Policy, Guidance and
Policy Development, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire

Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Brendan O'Leary, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5530, Silver Spring, MD 20993-0002, 301-
796-6898; or Stephen Ripley, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993,<PHONE_NUMBER> or Kristina
Lauritsen, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6162, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA has long regulated software that meets the definition of a
device in section 201(h) of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) (21 U.S.C. 321(h)), including software that is intended to
provide decision support to health care professionals, patients, or
caregivers for the diagnosis, treatment, prevention, cure, or
mitigation of diseases or other conditions (often referred to as CDS
software). Section 3060(a) of the Cures Act, enacted on December 13,
2016 (Pub. L. 114-255), amended section 520 of the FD&C Act (21 U.S.C.
360j) to exclude certain medical software functions, including certain
decision support software, from the definition of device under section
201(h) of the FD&C Act.
    This guidance describes CDS software functions that do not meet the
definition of a device in the context of and based on the criteria from
section 520(o) of the FD&C Act. This guidance also further clarifies
that FDA's existing digital health policies continue to apply to
software functions that meet the definition of a device, including
those that are intended for use by patients or caregivers. For example,
some decision support software functions may be identified in other
guidance documents as software functions for which, based on our
current understanding of the risks of these software functions, FDA
does not intend at this time to enforce compliance with applicable
device requirements of the FD&C Act, including, but not limited to,
premarket clearance and approval requirements.
    A notice of availability of the draft guidance appeared in the
Federal Register of September 27, 2019 (84 FR 51167). FDA considered
comments received and revised the guidance as appropriate in response
to the comments. In this final guidance, FDA provides clarification on
the terminology of ``Clinical Decision Support'' and focuses solely on
the criteria for Non-Device CDS. In response to comments received, the
final guidance no longer contains complementary information from the
International Medical Device Regulators Forum risk categories, and the
guidance provides additional explanation for how a software function,
regardless of its complexity, can be intended for the purpose of
enabling a healthcare professional to independently review the basis
for the software function's recommendations, such that the
recommendations are not primarily relied upon by the healthcare
professional.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on Clinical Decision Support Software. It does
not establish any rights for any person and is not binding on FDA or
the public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs.
Persons unable to download an electronic copy of ``Clinical Decision
Support Software; Guidance for Industry and Food and Drug
Administration Staff'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 1400062 and complete title to identify
the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
have been approved by OMB as listed in the following:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA
             form                        Topic           OMB control No.
------------------------------------------------------------------------
807, subpart E................  Premarket notification         0910-0120
814, subparts A through E.....  Premarket approval....         0910-0231
814, subpart H................  Humanitarian Device            0910-0332
                                 Exemption.
812...........................  Investigational Device         0910-0078
                                 Exemption.
``De Novo Classification        De Novo classification         0910-0844
 Process (Evaluation of          process.
 Automatic Class III
 Designation)''.
800, 801, and 809.............  Medical Device                 0910-0485
                                 Labeling Regulations.
314...........................  Applications for FDA           0910-0001
                                 Approval to Market a
                                 New Drug.
601; Form FDA 356h............  Biologics License;             0910-0338
                                 Application to Market
                                 a New Drug or
                                 Abbreviated New Drug
                                 or Biologic for Human
                                 Use--Form FDA 356h.
------------------------------------------------------------------------

    Dated: September 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-20993 Filed 9-27-22; 8:45 am]
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