         Supporting Statement for an Information Collection Request (ICR) Under the Paperwork Reduction Act (PRA)
EXECUTIVE SUMMARY
Identification of the Information Collection  -  Title and Numbers
      Title: TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; Proposed Rule
      ICR Numbers: EPA ICR No.: 2682.01; 	OMB Control No.: 2070-NEW
      EPA Form Numbers:  EPA Form #; EPA ####-#
      Docket ID Number: EPA-HQ-OPPT-2020-0549
Abstract
This ICR addresses the paperwork requirements in a proposed rule, titled "TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances" (RIN 2070-AK67) for the information collection activities of the one-time PFAS Data Call reporting and recordkeeping event (40 CFR Part 705). An economic analysis (EA) provides estimations of the burden and costs associated with the proposed reporting requirements and can be found in the rulemaking docket.
EPA is proposing reporting and recordkeeping requirements for Perfluoroalkyl or Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA) as amended by the Fiscal Year 2020 National Defense Authorization Act (NDAA). As mandated by the amendments, EPA is proposing to require certain persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, to electronically report to EPA certain information. This is a one-time reporting event to provide greater transparency on the uses and risks associated with PFAS and is mandated by the NDAA.
SUPPORTING STATEMENT PART A  -  JUSTIFICATION
    Explain the circumstances that make the collection of information necessary. Identify any legal or administrative requirements that necessitate the collection. Attach a copy of the appropriate section of each statute and regulation mandating or authorizing the collection of information.
As added by FY2020 National Defense Authorization Act, TSCA section 8(a)(7) (15 USC 2607, Attachment A) requires EPA to collect certain information on PFAS manufactured (including imported) in the United States since January 1, 2011. In addition, the requirements were put in place following enactment of the FY2020 National Defense Authorization Act, which amended TSCA in December 2019. The newly added provision states:
      (7) PFAS DATA. -- Not later than January 1, 2023, the Administrator shall promulgate a rule in accordance with this subsection requiring each person who has manufactured a chemical substance that is a perfluoroalkyl or polyfluoroalkyl substance in any year since January 1, 2011, to submit to the Administrator a report that includes, for each year since January 1, 2011, the information described in subparagraphs (A) through (G) of paragraph (2).
(see: Pub. L. 116-92, div. F, title LXXIII, § 7351)
Claims of confidentiality are covered under TSCA section 14 (See 82 FR 6522, January 19, 2017).
    Indicate how, by whom, and for what purpose the information is to be used. Except for a new collection, indicate the actual use the agency has made of the information received from the current collection.
Under TSCA, EPA is charged with protecting human health and the environment from potential chemical risks. Through the proposed PFAS Data Call regulation (Attachment B), EPA intends to collect exposure-related manufacturing information and all existing information concerning the environmental and health effects of the PFAS chemicals. These data are used by the Agency and others in a wide range of activities.
The information collected under this data call will improve EPA's exposure-related data on manufacturing, processing, and use of chemical substances that are PFAS, as well as require covered manufacturers to provide EPA with all existing information on the environmental or human health effects of such substances.
Additionally, under TSCA section 14, claims of confidentiality (other than for selected data elements such as production volume) must be substantiated at the time information is submitted to EPA, including as part of CDR (See 82 FR 6522, January 19, 2017). To ensure that EPA can use section 8(a) data most effectively, TSCA requires substantiation to enable EPA to review the legitimacy of confidentiality claims.
EPA's OPPT, other EPA Offices and/or other Federal agencies will generally be the primary groups for which information will be collected. However, to the extent that reported information is not considered to be CBI, EPA may consider providing such data to other non-Federal entities, including the general public.
The reporting methods, including the reporting tool and electronic registration, help to ensure that the information reported to EPA is accurate and in compliance with the statutory requirements. In addition, the data elements have practical utility for users of the data within EPA. Staff in OPPT would be able to use information collected on the production volumes, categories of use, disposal, byproducts, and worker-related information in future screening-level assessments of potential exposure to these PFAS. Additionally, other offices in EPA would benefit from information collected, such as data on the disposal, releases, and other waste management methods of PFAS. Many offices across EPA are fulfilling directives under the Agency's PFAS Action Plan, and this first nationwide dataset on PFAS, production, use, disposal, and exposure-related information would complement these activities and provide necessary screening-level data.
    Describe whether, and to what extent, the collection of information involves the use of automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses, and the basis for the decision for adopting this means of collection. Also describe any consideration of using information technology to reduce burden.
The Paperwork Reduction Act (PRA) requires Federal agencies to manage information resources to reduce information collection burdens on the public; increase program efficiency and effectiveness; and improve the integrity, quality, and utility of information to all users within and outside an agency, including capabilities for ensuring dissemination of public information, public access to Federal Government information, and protections for privacy and security (44 U.S.C. 3506). Section 2 of TSCA expresses the intent of Congress that EPA carry out TSCA in a reasonable and prudent manner, and in consideration of the impacts that any action taken under TSCA may have on the environment, the economy, and society (15 U.S.C. 2601). EPA believes that it is reasonable and prudent to manage and leverage its information resources, including information technology (IT), to require the use of electronic reporting in the implementation of TSCA. Electronic reporting can minimize burden and costs for the regulated entities by avoiding the costs associated with printing and mailing this information to EPA, while at the same time improving EPA's efficiency in reviewing submitted information, making decisions and disseminating information to the public.
EPA proposes to require electronic reporting for all reporting submissions. Persons submitting information under this 8(a)(7) rule would be required to use the PFAS Reporting Tool, a reporting application accessed through the Agency's CDX platform. The PFAS Reporting Tool would be based on e-CDRweb, the Agency's online application for completing the CDR reporting form (Form U) in the 2020 CDR reporting cycle. EPA will make updates to this required reporting tool to address the final changes. Mockups of the PFAS Reporting Tool based on the current e-CDRweb reporting tool screen shots are included as Attachment C.
    Describe efforts to identify duplication. Show specifically why any similar information already available cannot be used or modified for use for the purposes described in Item 2 above.
The data included in this information collection are not collected comprehensively or systematically at the national level by any other entities with the exception of some of the data elements for which certain PFAS are reported under CDR and TSCA section 5 Premanufacture Notices (PMN). However, no dataset has consistently collected such information for each year since 2011; CDR has a four-year reporting cycle which does not require all information to be reported for each intervening year. In instances where PFAS manufacturers under this proposed rule have already reported the requested information to EPA for that same year, they will not be required to re-report. However, EPA expects that most firms will need to submit information under the proposed rule, even if they have previously reported to CDR or submitted a PMN because the proposed rule requests different information than either CDR or PMN forms. Additionally, this rule requires reporting for each year since 2011 in which a PFAS was manufactured, whereas reporting is not required annually for CDR. In addition, firms that have not previously submitted information to CDR or through a PMN form will need to submit data under the proposed rule.
TSCA section 8(a)(5) requires EPA, to the extent feasible when carrying out TSCA section 8, to avoid requiring unnecessary or duplicative reporting. The Agency seeks to avoid collecting data on PFAS that would duplicate information already reported to the Agency. While developing this rule EPA reviewed the data elements submitted under the Chemical Data Reporting Rule and determined that there may be some overlap with the information requested under the proposed rule. EPA is proposing to allow reporting entities to indicate in the reporting tool that they have previously provided such information to EPA through CDR for certain data elements. The Agency has identified the following data elements which the reporter may be able to indicate has already been submitted to EPA:
 Physical state of the chemical or mixture;
 Industrial processing and use type, sector(s), functional category(ies), and percent of production volume for each use;
 Consumer and/or commercial indicator, product category(ies), functional category(ies), percent of production volume for each use, indicator for use in products intended for children, and maximum concentration in the product, and;
 Number of workers reasonably likely to be exposed for each combination of industrial processing or use operation, sector, and function, and the number of commercial workers reasonably likely to be exposed if the PFAS is contained in a commercial product.
If a manufacturer covered under this proposed rule has previously submitted required information to EPA for some years since 2011, but not for all years, EPA is proposing that the manufacturer may indicate in the reporting tool the year(s) for which the manufacturer has already submitted that data to EPA as part of CDR. For instance, CDR reporters are required to submit the total annual domestically manufactured production volume and the total annual imported volume separately, only for the principal reporting year (e.g., 2019 for the 2020 reporting cycle), but reporting only the combined total annual production volume is required for the intervening years. In this case, a reporter under this proposed rule would be able to indicate that the two different production volumes have been previously submitted to EPA for the CDR reporting year(s), but would still need to report for the intervening year(s) not previously submitted under CDR. Additionally, there are some data elements for which CDR reporters may have previously reported information to EPA, although these data elements were only added to the CDR reporting requirements in 2020. Therefore, some manufacturers under this proposed rule may have submitted the following information to CDR for some years covered by this proposed rule, but not all, and would still be required to report this information for the missing year(s):
 Domestically manufactured production volume;
 Imported production volume;
 Volume directly exported; and
 Indicator for imported but never physically at site.
    If the collection of information impacts small businesses or other small entities, describe any methods used to minimize burden.
Unlike TSCA section 8(a)(1) rules, the proposed rule under TSCA section 8(a)(7) would not exempt small manufacturers from reporting and recordkeeping requirements. TSCA section 8(a)(7) does not provide EPA with authority to establish any reporting exemptions in the required rulemaking. EPA is requesting public comment on how the Agency may assist small manufacturers with compliance with the proposed rule, including comments related to both regulatory and non-regulatory assistance, such as different reporting timelines and outreach.
    Describe the consequence to Federal program or policy activities if the collection is not conducted or is conducted less frequently, as well as any technical or legal obstacles to reducing burden.
This is a one-time statutorily mandated reporting event. Failure to conduct the information collection activities required by law would subject EPA to Congressional oversight and civil litigation. Further, EPA believes that the statutory requirement that "each person" who manufactured PFAS since 2011 report information under the rule does not permit EPA to provide for reporting exemptions or flexibilities that could otherwise reduce burden.
    Explain any special circumstances that would cause an information collection to be conducted in a manner:
 requiring respondents to report information to the agency more often than quarterly;
 requiring respondents to prepare a written response to a collection of information in fewer than 30 days after receipt of it;
 requiring respondents to submit more than an original and two copies of any document; requiring respondents to retain records, other than health, medical, government contract, grant-in-aid, or tax records, for more than three years;
 in connection with a statistical survey, that is not designed to produce valid and reliable results that can be generalized to the universe of study;
 requiring the use of a statistical data classification that has not been reviewed and approved by OMB;
 that includes a pledge of confidentiality that is not supported by authority established in statute or regulation, that is not supported by disclosure and data security policies that are consistent with the pledge, or which unnecessarily impedes sharing of data with other agencies for compatible confidential use; or
 requiring respondents to submit proprietary trade secrets, or other confidential information unless the agency can demonstrate that it has instituted procedures to protect the information's confidentiality to the extent permitted by law.
 The proposed record retention period of this collection is five years, as specified in 40 CFR 711.25, exceeding the PRA maximum of three years. The five-year retention requirement corresponds with the statute of limitations for violations established under 28 U.S.C. 2462. A five-year retention requirement for records related to compliance with the rule is needed to support EPA's ability to monitor compliance with the reporting requirements. When assessing compliance, inspectors and other enforcement personnel rely upon a facility's records of, for example, chemical identity, importation dates, volumes, and distribution location. EPA's inspection resources are limited and as such having records of compliance for five years becomes even more important to assure the reporting obligations are met.
    If applicable, provide a copy and identify the date and page number of publication in the Federal Register of the agency's notice, required by 5 CFR 1320.8(d), soliciting comments on the information collection prior to submission to OMB. Summarize public comments received in response to that notice and describe actions taken by the agency in response to these comments. Specifically address comments received on cost and hour burden.

Describe efforts to consult with persons outside the agency to obtain their views on the availability of data, frequency of collection, the clarity of instructions and recordkeeping, disclosure, or reporting format (if any), and on the data elements to be recorded, disclosed, or reported.

Consultation with representatives of those from whom information is to be obtained or those who must compile records should occur at least once every 3 years - even if the collection of information activity is the same as in prior periods. There may be circumstances that may preclude consultation in a specific situation. These circumstances should be explained.
Pursuant to the procedures at 5 CFR 1320.11, the notice of proposed rulemaking serves as the public notice for this rule-related ICR. Upon publication, the This proposed rule will open a 60-day public comment period. Public comments will be considered during the development of the final rule. EPA will respond to all comments in the final rule.
    Explain any decision to provide any payment or gift to respondents, other than remuneration of contractors or grantees.
This collection of information is required by statute. The federal government will not offer any monetary or material value for responses to this information collection.
    Describe any assurance of confidentiality provided to respondents and the basis for the assurance in statute, regulation, or agency policy. If the collection requires a systems of records notice (SORN) or privacy impact assessment (PIA), those should be cited and described here.
Confidentiality claims limit access to the PFAS data, especially by the public. EPA recognizes that some information submitted to the Agency is legitimately confidential.  Therefore, EPA's review of confidential data is an inherently governmental function that EPA must perform to protect human health and the environment. EPA has identified specific data elements that cannot be claimed as confidential, consistent with CDR reporting. Also consistent with CDR reporting, EPA will require submitters provide upfront substantiation when claiming eligible data elements as CBI in this proposed rule.
Submitters may claim most information reported to EPA under this rule as confidential if such information would reveal the submitter's trade secrets or proprietary information as defined by TSCA section 14 and existing regulations promulgated by EPA under TSCA.
EPA has long-established procedures for properly handling, storing, processing, and disposing of TSCA confidential information. Transfers of this information to others as allowed under TSCA section 14(d) can be made only if the other entity agrees to adhere to all TSCA confidentiality provisions. EPA will maintain standard confidentiality procedures to protect any confidential, trade secret, or proprietary information from disclosure in accordance with EPA's confidentiality regulation, 40 CFR Part 2, Subpart B.
    Provide additional justification for any questions of a sensitive nature, such as sexual behavior and attitudes, religious beliefs, and other matters that are commonly considered private. This justification should include the reasons why the agency considers the questions necessary, the specific uses to be made of the information, the explanation to be given to persons from whom the information is requested, and any steps to be taken to obtain their consent.
 No information of a sensitive or private nature is requested in conjunction with this information collection activity, and this information collection activity complies with the provisions of the Privacy Act of 1974 and OMB Circular A-108.
    Provide estimates of the hour burden of the collection of information. The statement should:
 Indicate the number of respondents, frequency of response, annual hour burden, and an explanation of how the burden was estimated. Unless directed to do so, agencies should not conduct special surveys to obtain information on which to base hour burden estimates. Consultation with a sample (fewer than 10) of potential respondents is desirable. If the hour burden on respondents is expected to vary widely because of differences in activity, size, or complexity, show the range of estimated hour burden, and explain the reasons for the variance. Generally, estimates should not include burden hours for customary and usual business practices.
 If this request for approval covers more than one form, provide separate hour burden estimates for each form and aggregate the hour burdens.
 Provide estimates of annualized cost to respondents for the hour burdens for collections of information, identifying and using appropriate wage rate categories. The cost of contracting out or paying outside parties for information collection activities should not be included here. Instead, this cost should be included under `Annual Cost to Federal Government'.
Methodology for Estimating Respondent Burden and Costs
The regulated community consists of companies manufacturing (including importing) PFAS chemical substances in any year since January 1, 2011. An estimated 234 firms and 351 sites are expected to be subject to this rule's reporting requirements. Note that EPA is not able to estimate the number of article importers who may be subject to the proposed rule and thus does not include these firms in the total estimated number of respondents.
Based on the parent companies that reported manufacturing or importing PFAS chemicals subject to the proposed rule to the 2016 CDR, the Agency's previous experience with TSCA section 8(a) data collections, and the Agency's understanding of disposal and other waste management methods involving PFAS, the Agency expects that this rule will affect firms in the NAICS categories listed in Table 1. The list in Table 1 is not exhaustive and may not describe the specific entities and corresponding NAICS codes for entities that may be affected by the proposed rule.
Table 1: Expected Respondents by NAICS Code
NAICS Code
Subsector Description
324
Petroleum and Coal Product Manufacturing
325
Chemical Manufacturers and Processors
325180
Other Basic Inorganic Chemical Manufacturing
325199
All Other Basic Organic Chemical Manufacturing
325211
Plastics Material and Resin Manufacturing
325320
Pesticide and Other Agricultural Chemical Manufacturing
325998
All Other Miscellaneous Chemical Product and Preparation Manufacturing
326113
Unlaminated Plastics Film and Sheet (except Packaging) Manufacturing
327910
Abrasive Product Manufacturing
333999
All Other Miscellaneous General Purpose Machinery Manufacturing
334511
Search, Detection, Navigation, Guidance, Aeronautical, and Nautical System and Instrument Manufacturing
336111
Automobile Manufacturing
423510
Metal Service Centers and Other Metal Merchant Wholesalers
424690
Other Chemical and Allied Products Merchant Wholesalers
447190
Other Gasoline Stations
551112
Offices of Other Holding Companies
562
Waste Management and Remediation Services

The subsectors identified above represent the designation of sites that likely would be subject to this data collection activity. However, this list does not include all potentially affected entities. Other types of entities not listed in this unit could also be subject to reporting.
For the analysis in this section, the respondent is defined as a manufacturing firm. It is assumed that there is an average of 5.85 responses per respondent, which is the average number of PFAS chemicals per firm in the 2016 CDR data.  Incremental activities associated with preparing and submitting a response under the rule include rule familiarization, form completion, CBI claim substantiation, recordkeeping, and CDX registration, including e-signature. General descriptions of changes to activities are as follows (see previous section for detailed data element information):
       Rule Familiarization: The proposed rule requires reporting businesses and their staff to become familiar with the TSCA section 8(a) rule and its various requirements.  This activity entails reading the rule, understanding the reporting and administrative requirements, and determining what tasks are required in order to meet reporting requirements.
      Form Completion: The proposed rule requires one-time reporting of certain information, including chemical identity, categories of use, production volume, byproducts, environmental and health effects, occupational exposure, and disposal.
      CBI Claim Substantiation: TSCA requires that anyone seeking protection of CBI must assert a claim and, for certain information, may be required to substantiate that claim. Reporting elements of the proposed rule for which a submitter might need to substantiate a claim of CBI, if a claim is made, include submitter information; chemical identity; physical properties; production volumes and product concentrations; byproducts; environmental release; worker exposure information; and description of disposal process(es).
      Recordkeeping: The proposed rule requires respondents to retain documentation of information contained in their reports for five years after the date of submission.
      CDX Registration and Electronic Signature: Respondents that submit a report will need to register with CDX in order to comply with electronic reporting requirements. This activity occurs only once for each submitter. Some submitters may have already registered to use the e-TSCA web reporting tool in CDX (and obtained an accompanying electronic signature) in order to comply with mandatory electronic reporting requirements of EPA's e-PMN rule and/or CDR rule. Those submitters will not need to repeat the CDX registration and e-signature process in order to file their reports. While there may be some overlap in the specific individuals that have already completed CDX activities, EPA is conservatively expecting that all firms that submit a report under this proposed rule will need to register with CDX.
      Article Importation Activities: Importers have varying levels of knowledge about the chemical content of the articles they import. The reporting standard would require reporting entities to evaluate their current level of knowledge of their imported articles, as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This standard requires that submitters conduct a reasonable inquiry within the full scope of their organization and may also entail inquiries outside the organization to fill gaps in the submitter's knowledge.
Data Elements for the PFAS Reporting Form
As mandated under section 8(a)(7), the Agency must collect certain information on PFAS manufactured in any year since 2011. The information requested is authorized under section 8(a)(2), and includes reporting with respect to information including chemical identity, categories of use, production volume (in total and with respect to each category of use), description of byproducts, the number of individuals exposed at their places of work, and the methods of disposal. EPA is also authorized to request all existing information related to environmental and health effects of PFAS.
Specifically, EPA is proposing to request the following information from any person who has manufactured PFAS in any year since 2011, and the information would be collected for each year:
       Chemical name (multiple if mixture), or the generic name(s) if the chemical name(s) is CBI
       Chemical ID(s) (CASRN, TSCA Accession Number, or Low-Volume Exemption (LVE) case number)
       Trade name or common name
       Molecular structure
       Physical form of chemical or mixture
       Industrial processing and use: type of process or use; sector(s); function category(ies); percent of production volume for each use
       Consumer and commercial use: consumer and/or commercial indicator; product category; function category(ies); percent production volume for each use; maximum concentration in any product; indicator for use in products intended for children
       Production volumes: domestically manufactured; imported; directly exported; maximum first 12 months production volume; maximum yearly production volume in any 3 years
       Indicator for imported but never physically at site
       Indicator for site-limited
       Maximum quantity stored on-site at any time
       Total volume recycled (on-site)
       Information on byproducts produced during the manufacture, processing, use or disposal of the PFAS:
            Byproduct chemical name(s) or description (if unknown), or the generic name(s) if the byproduct name(s) is CBI
            Chemical ID(s), if available (CASRN, TSCA Accession Number, or LVE case number)
            Indicator for whether byproduct production stemmed from manufacture, process, use, or disposal
            Indicator for whether the byproduct(s) are released to the environment; if so, volume released and to which environmental media
       Worker activity descriptions at manufacturing site
       Worker exposure at the manufacturing site: number of workers reasonably likely to be exposed at the manufacturing site, for each worker activity; maximum duration of exposure for any worker, for each worker activity (both hours per day and days per year)
       Worker exposure for each industrial process and use: number of workers reasonably likely to be exposed for each industrial process and use; maximum duration of exposure for any worker for each industrial process and use (both hours per day and days per year)
       Worker exposure for each commercial use: number of workers reasonably likely to be exposed for each commercial use; maximum duration of exposure for any worker for each commercial use (both hours per day and days per year)
       Description of disposal process(es), and description of any changes to the disposal process or methods since 2011
       Total volume released: land disposal; water; air
       Total volume incinerated (on-site) and incineration temperature
       All existing information related to the health or environmental effects, using the OECD harmonized template, as well as study reports and other supporting information
       Other data relevant to health effects (e.g., range-finding studies, preliminary studies, OSHA medical screening or surveillance standards reports, adverse effects reports)
Incremental experienced reporter unit burden for respondent activities associated with the proposed rule is presented in Table 3. Unit burdens in this table reflect changes in activities that are applied universally to all reporters. The activity-level unit burden estimates for changes in Table 3 are based on estimates for similar activities (for more detail, see EPA (2020)). The total average burden is estimated to be 521.81 hours per firm.
Wages and fringe benefit data for managerial, professional/technical, and clerical labor are from the BLS Employer Costs for Employee Compensation (ECEC) historical data for December 2020 (BLS 2021a).  For attorney, the wage rate was taken from the BLS Occupational Employment Statistics (OES) May 2020 National Industry-Specific Occupational Employment and Wage Estimates for Sectors 31, 32, and 33  -  Manufacturing and SOC Code 23-1011  -  Lawyers (BLS 2021b).
The costs of fringe benefits such as paid leave and insurance, specific to each labor category, are taken from the same BLS report (BLS 2021a). Overhead costs are assumed to equal 20% of the sum of wages plus fringe benefits. This loading factor is described in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (EPA 2020c), and is reflective of multiplier values used in prior EPA economic analyses and ICRs that are based on industry- and occupation-specific overhead rates affected by EPA regulations.
Table 2 contains the loaded wage rates for the managerial, technical, clerical, and attorney occupation categories.
Table 2: Reporter Wager Rates (2020$)
                                Labor Category
                       Data Source for Wage Information
                                    Wage[1]
                               Fringe Benefit[2]
                              Total Compensation
                      Overhead % of Total Compensation[3]
                                   Overhead
                            Hourly Loaded Wages[4]

                                       A
                                       B
                                   C = A + B
                                       D
                                   E = C x D
                                   F = C + E
Clerical
BLS ECEC, Private Manufacturing industries, "Office and administrative support occupations"
                                                                        $20.86
                                                                         $9.62
                                                                        $30.48
                                                                            20%
                                                                         $6.10
                                                                        $36.58
Professional/Technical
BLS ECEC, Private Manufacturing industries, "Professional and related occupations"
                                                                        $44.63
                                                                        $22.45
                                                                        $67.08
                                                                            20%
                                                                        $13.42
                                                                         $80.50
Managerial
BLS ECEC, Private Manufacturing industries, "Management, business, and financial occupations"
                                                                        $54.32
                                                                        $24.46
                                                                        $78.78
                                                                            20%
                                                                        $15.76
                                                                         $94.54
Attorney
BLS OES, Occupational Employment and Wages, 23-1011 Lawyers
                                                                        $71.59
                                                                        $17.96
                                                                        $89.55
                                                                            20%
                                                                        $17.91
                                                                       $107.46
1 Source: Employer Costs for Employee Compensation Supplementary Tables: December 2020 (BLS 2021a); National Industry-Specific Occupational Employment and Wage Estimates, May 2020 (BLS 2021b).
2 Source: Employer Costs for Employee Compensation Supplementary Tables: December 2020 (BLS 2021a)
3 An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and other U.S. EPA Actions (EPA 2020c).
4 Values may not sum due to rounding. Wage rates are rounded to the nearest cent.

Table 3: PFAS Data Call Reporting: Activity-Level Reporter Unit Burden
                                   Activity
                            Clerical Burden (hours)
                           Technical Burden (hours)
                           Managerial Burden (hours)
                  Activity-Level Unit Burden per Average Firm
                         Proportion of Firms Affected
                         Average Unit Burden per Firm
Rule Familiarization
0.00
0.55
0.27
0.82
1.00
0.82
Form Completion

   Company and plant site information
0.00
0.02
0.01
0.03
1.00
0.03
   Common or trade name, chemical identity, and molecular structure
10.24
26.33
5.85
42.41
1.00
42.41
   Byproducts
0.00
2.93
0.00
2.93
1.00
2.93
   Conditions of use
0.00
26.00
10.65
36.65
1.00
36.65
   Total production volume
0.00
50.19
12.69
62.89
1.00
62.89
   Occupational exposure
0.00
78.98
0.00
78.98
1.00
78.98
   Environmental release and disposal
0.00
55.58
0.00
55.58
1.00
55.58
   Environmental and health effects data
0.00
1,263.60
0.00
1,263.60
0.18
227.45
CBI Substantiation
11.12
0.00
11.12
22.23
0.25
5.56
Recordkeeping
2.93
2.93
0.00
5.86
1.00
5.86
CDX Registration
0.00
1.73
0.93
2.67
1.00
2.67
                                             Total average unit burden per firm
521.81
Note: For additional details on development and assumptions associated with items in this table, see the source EA (EPA 2020). Numbers may not sum due to rounding.

Unit costs are derived by combining relevant wage information with unit burden estimates. See Table 2 for information on the industry wage rates used in this analysis. In addition, EPA estimates each firm will incur a $3.15 in material costs for filing the electronic signature agreement when registering with CDX. EPA estimates reporter burden and cost at approximately $42,000 per firm, shown in Table 4.

Table 4: PFAS Data Call Reporting: Activity-Level Reporter Unit Cost
                                   Activity
                         Average Unit Burden per Firm
                      Average Unit Cost per Firm (2020$)
Rule Familiarization
                                                                           0.82
                                                                           $70
Form Completion

   Company and plant site information
                                                                           0.03
                                                                            $3
   Common or trade name, chemical identity, and molecular structure
                                                                          42.41
                                                                        $3,047
   Byproducts
                                                                           2.93
                                                                          $235
   Conditions of use
                                                                          36.65
                                                                        $3,100
   Total production volume
                                                                          62.89
                                                                        $5,240
   Occupational exposure
                                                                          78.98
                                                                        $6,357
   Environmental release and disposal
                                                                          55.58
                                                                        $4,474
   Environmental and health effects data
                                                                         227.45
                                                                       $18,309
CBI Substantiation
                                                                           5.56
                                                                          $561
Recordkeeping
                                                                           5.86
                                                                          $343
CDX Registration
                                                                           2.67
                                                                          $231
Total
                                                                         521.81
                                                                       $41,969
Note: For additional details on development and assumptions associated with items in this table, see the source EA (EPA 2020). Numbers may not sum due to rounding.

Estimates of the total industry reporting burden and cost are shown in Table 5. Total burden and cost are calculated by multiplying the unit burdens and costs in Table 4 by the respective number of reporting sites. EPA estimates a total burden of 122,104 hours and a total cost of $9,820,813.
Table 5: PFAS Data Call Reporting: Total Estimated Respondent Burden and Costs
                                   Activity
                                Number of Firms
                              Number of Responses
                             Per-Firm Unit Burden
                              Per-Firm Unit Cost
                                 Total Burden
                              Total Cost (2020$)
Rule Familiarization
234
1,369
1
$70
192
$16,331
Form Completion
234
1,369
507
$40,764
118,616
$9,538,839
CBI Substantiation
234
1,369
6
$561
1,300
$131,343
Recordkeeping
234
1,369
6
$343
1,371
$80,267
CDX Registration
234
1,369
3
$231
624
$54,033
Total
234
1,369
522
$41,969
122,104
$9,820,813

    Provide an estimate for the total annual cost burden to respondents or record keepers resulting from the collection of information. (Do not include the cost of any hour burden already reflected on the burden worksheet).
 The cost estimate should be split into two components: (a) a total capital and start-up cost component (annualized over its expected useful life) and (b) a total operation and maintenance and purchase of services component. The estimates should take into account costs associated with generating, maintaining, and disclosing or providing the information. Include descriptions of methods used to estimate major cost factors including system and technology acquisition, expected useful life of capital equipment, the discount rate(s), and the time period over which costs will be incurred. Capital and start-up costs include, among other items, preparations for collecting information such as purchasing computers and software; monitoring, sampling, drilling and testing equipment; and record storage facilities.
 If cost estimates are expected to vary widely, agencies should present ranges of cost burdens and explain the reasons for the variance. The cost of purchasing or contracting out information collections services should be a part of this cost burden estimate. In developing cost burden estimates, agencies may consult with a sample of respondents (fewer than 10), utilize the 60-day pre-OMB submission public comment process and use existing economic or regulatory impact analysis associated with the rulemaking containing the information collection, as appropriate.
 Generally, estimates should not include purchases of equipment or services, or portions thereof, made: (1) prior to October 1, 1995, (2) to achieve regulatory compliance with requirements not associated with the information collection, (3) for reasons other than to provide information or keep records for the government, or (4) as part of customary and usual business or private practices.
The information collection activities addressed in the proposed rule do not involve any cost burdens, such as capitalization, start-up, and/or operation and maintenance costs.
    Provide estimates of annualized costs to the Federal government. Also, provide a description of the method used to estimate cost, which should include quantification of hours, operational expenses (such as equipment, overhead, printing, and support staff), and any other expense that would not have been incurred without this collection of information. Agencies may also aggregate cost estimates from Items 12, 13, and 14 in a single table.
The Agency develops and maintains the electronic tool used to collect and verify data and routinely conducts other activities related to the processing, analysis and storage of the information collected under this rule. In this ICR Addendum, only the Agency activities created by the proposed rule are considered including: data processing, systems support, and review of CBI claim substantiations.
The Agency engages in several activities related to TSCA section 8(a) reporting, including: document receipt and tracking; quality control of data; including protection of CBI; backup systems operation; data processing; systems support; review of CBI claim substantiations; and IT infrastructure. For the PFAS Data Call, EPA estimates a total burden of 7,361 hours and a cost of $948,078 to the Agency for the one-time reporting.
EPA activities affected by the rule involve data processing, systems support, review of CBI claim substantiations, and IT infrastructure. Costs related to EPA activities that involve data use are not included.
EPA labor costs are based on annual federal wage rates, as presented in Table 6. EPA assumes that the collection and administrative activities (technical labor) associated with Agency responses to the proposed rule will be accomplished by a GS-13, Step 5 federal employee in the Washington-Baltimore-Northern Virginia area. EPA assumes that a GS-14, Step 5 federal employee will perform attorney activities related to CBI claim substantiations.
Table 6: Agency Wage Rate (2020$)
                                Labor Category
                       Data Source for Wage Information
                                 Wage ($/hour)
                            Fringes as % of Wage[2]
                                Fringe Benefit
                              Total Compensation
                    Overhead as % of Total Compensation[3]
                                   Overhead
                              Loaded Wage ($/hr)

                                       A
                                       B
                                   C = A * B
                                   D = A + C
                                       E
                                   F = D * E
                                   G = D + F
Technical
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-13 Step 5 pay rates[1]
                                    $55.75
                                     63.9%
                                    $35.62
                                    $91.37
                                     20.0%
                                    $18.27
                                   $109.65
Attorney
Annual federal staff cost: OPM Washington-Baltimore-Northern Virginia, DC-MD-PA-VA-WV area, GS-14 Step 5 pay rates[1]
                                    $65.88
                                     63.9%
                                    $42.10
                                   $107.98
                                     20.0%
                                    $21.60
                                   $129.57
[1] Source: U.S. Office of Personnel Management (2020)
[2] Source: Falk 2012
[3] An overhead rate of 20% is used based on assumptions in Handbook on Valuing Changes in Time Use Induced by Regulatory Requirements and Other U.S. EPA Actions (EPA 2020c)
Unit burden and cost associated with EPA staff activities are the same as in the economic analysis for the proposed rule (EPA, 2020)  and are presented in Table 7. The cost associated with data processing, systems support, and review of CBI claim substantiations is performed by program staff and is dependent on the number of chemical reports received.
Table 7: Total Agency Burden and Cost (2020$)
                                 EPA Activity
                                Burden (hours)
                                 Cost (2020$)

                                   Technical
                                   Attorney
                                     Total
                            Technical ($109.65/hr)
                             Attorney ($129.57/hr)
                                     Total
Data Processing and Systems Support
3.13
0
3.13
$343.34
$0.00
$343.34
Review of CBI Claim Substantiations (per Report)

   Chemical Identity
0.25
0
0.25
$27.01
$0.00
$27.01
   Other
0.5
1.5
2
$54.82
$194.36
$249.18
Total (per Report)
3.9
1.5
5.4
$425.17
$194.36
$619.53
IT Infrastructure
-
-
-
-
-
$100,000
Total Agency Burden and Cost (x 1,369 reports)
5,308
2,053
7,361
$582,020
$266,058
$948,078

    Explain the reasons for any program changes or adjustments reported on the burden worksheet.
The program changes reported on the burden worksheet are due to a new statute, the National Defense Authorization Act for Fiscal Year 2020, that amended TSCA section 8(a) by adding a new provision that requires EPA to promulgate one-time PFAS information requirements by rule.
    For collections of information whose results will be published, outline plans for tabulation and publication. Address any complex analytical techniques that will be used. Provide the time schedule for the entire project, including beginning and ending dates of the collection of information, completion of report, publication dates, and other actions.
This is a one-time reporting event. The submission period will begin after the final effective date of the rule and will last for five months. This submission period duration is the same as the 2016 Chemical Data Reporting (CDR) period.
Activity
Timeline
Public outreach efforts: Federal Register publication of proposed rule and 60-day public comment period open; information on the CDR website
2021
Email to 2020 CDR e-mailing list and other stakeholders with instructions for obtaining the reporting form and initiating reporting
Late 2022-early 2023
Open period for submitting reporting forms and existing data
Beginning 6 months after final effective date; reporting period lasts for 6 months

Submitters are required to submit information associated with this data collection electronically via the Internet using the PFAS Reporting Tool within CDX.
EPA notifies potential submitters of the need to report in three ways: (1) makes available guidance describing reporting requirements through web and listserv announcements, (2) sends email notices to previous CDR submitters and other potential stakeholders, and (3) publishes press releases. The requirement to report is based on TSCA section 8(a)(7); potential submitters that do not receive a notification as listed above or who do not read published articles are still required to report. Reporting materials, including a non-submission version of the required information and reporting instructions documents will be available on EPA's TSCA website. Submitters can also obtain these materials from the TSCA Hotline. Submitters obtain the PFAS Reporting Tool (which enables the completion of the reporting form for submission) as part of the CDX electronic web-based registration process.
EPA will receive all submissions electronically. The CDX registration process, required for all submitters, provides a user ID, which the submitter uses to access the PFAS Reporting Tool. EPA anticipates that many submitters will already have registered for CDX to fulfill other reporting programs, such as CDR or the Toxics Release Inventory.
Information quality control and validation will begin with the PFAS Reporting Tool, which is programmed to help the submitter provide the information required, in the correct format, as required by the proposed rule.
To aid persons subject to this information collection, the Agency's TSCA and CDX Hotlines will be available to answer questions regarding the reporting requirements or submission process. When Hotline staff are unable to answer questions, the submitter is referred to OPPT programmatic staff. Other divisions within OPPT or the Office of Mission Support (OMS) may respond as necessary.
EPA is requesting public comment on the extent to which non-CBI data submitted under this rule should be published and made available to the general public, and expects to make a relevant determination before promulgating the final rule.
    If seeking approval to not display the expiration date for OMB approval of the information collection, explain the reasons that display would be inappropriate.
Not applicable. The expiration date of OMB's approval of this information collection will be displayed.
    Explain each exception to the topics of the certification statement identified in "Certification for Paperwork Reduction Act Submissions."
As explained under #7, the proposed record retention period of this collection is five years, exceeding the PRA maximum of three years. The five-year retention requirement corresponds with the statute of limitations for violations established under 28 U.S.C. 2462.
SUPPORTING STATEMENT PART B  -  COLLECTION OF INFORMATION EMPLOYING STATISTICAL METHODS
This information collection does not employ any statistical methods.
SUPPORTING STATEMENT ATTACHMENTS
The attachments referenced in this ICR are listed below and are available in the public docket established for this ICR under docket ID number EPA-HQ-OPPT-2020-0549 are available for online viewing at http://www.regulations.gov unless otherwise noted.

Attachment A:
Toxic Substances Control Act (TSCA) Section 8 - 15 USC 2607
(available online at https://www.govinfo.gov/content/pkg/USCODE-2019-title15/pdf/USCODE-2019-title15-chap53-subchapI-sec2607.pdf)
Attachment B:
TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances; Proposed Rule (RIN 2070-AK67)
Attachment C
PFAS Reporting Tool Mockups


[Federal Register Volume 78, Number 23 (Monday, February 4, 2013)]
[Notices]
[Pages 7786-7787]
[FR Doc No: 2013-02296]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0068]

International Conference on Harmonisation; Draft Guidance on S10
Photosafety Evaluation of Pharmaceuticals; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``S10 Photosafety Evaluation
of Pharmaceuticals.'' The draft guidance was prepared under the
auspices of the International Conference on Harmonisation (ICH) of
Technical Requirements for Registration of Pharmaceuticals for Human
Use. The draft guidance includes criteria for initiation of and
triggers for additional photosafety testing and should be read in
conjunction with the ICH M3(R2) guidance, section XIV(14) Photosafety
Testing. The purpose of the draft guidance is to recommend
international standards for photosafety assessment and to harmonize
such assessments that support human clinical trials and marketing
authorization for pharmaceuticals.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by March 21, 2013.

ADDRESSES: Submit written requests for single copies of the draft
guidance to the Division of Drug Information (HFD-240), Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist the office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT:
    Regarding the guidance: Abigail Jacobs, Center for Drug Evaluation
and Research (ONDIO), Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 22, Rm. 6484, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.
    Regarding the ICH: Michelle Limoli, Center for Drug Evaluation and
Research, International Programs, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, rm. 3342, Silver Spring, MD 20993-0002,
301-796-8377.

SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry

associations to promote international harmonization of regulatory
requirements. FDA has participated in many meetings designed to enhance
harmonization and is committed to seeking scientifically based
harmonized technical procedures for pharmaceutical development. One of
the goals of harmonization is to identify and then reduce differences
in technical requirements for drug development among regulatory
Agencies.
    ICH was organized to provide an opportunity for tripartite
harmonization initiatives to be developed with input from both
regulatory and industry representatives. FDA also seeks input from
consumer representatives and others. ICH is concerned with
harmonization of technical requirements for the registration of
pharmaceutical products among three regions: The European Union, Japan,
and the United States. The six ICH sponsors are the European
Commission; the European Federation of Pharmaceutical Industries
Associations; the Japanese Ministry of Health, Labour, and Welfare; the
Japanese Pharmaceutical Manufacturers Association; the Centers for Drug
Evaluation and Research and Biologics Evaluation and Research, FDA; and
the Pharmaceutical Research and Manufacturers of America. The ICH
Secretariat, which coordinates the preparation of documentation, is
provided by the International Federation of Pharmaceutical
Manufacturers Associations (IFPMA).
    The ICH Steering Committee includes representatives from each of
the ICH sponsors and the IFPMA, as well as observers from the World
Health Organization, Health Canada, and the European Free Trade Area.
    In November 2012, the ICH Steering Committee agreed that a draft
guidance entitled ``S10 Photosafety Evaluation of Pharmaceuticals''
should be made available for public comment. The draft guidance is the
product of the S10 Expert Working Group of the ICH. Comments about this
draft will be considered by FDA and the S10 Expert Working Group.
    The ICH S10 draft guidance provides guidance on when photosafety
testing is warranted, and on possible testing strategies. It represents
the consensus that exists regarding assessment of photosafety to
support clinical development and marketing authorization of
pharmaceuticals. It supplements the ICH M3(R2) guidance,\1\ which (1)
provides certain information regarding timing of photosafety testing
relative to clinical development and (2) recommends that an initial
assessment of photoreactive potential be conducted and, if appropriate,
an experimental evaluation be undertaken before exposure of large
numbers of subjects. However, the ICH M3(R2) guidance does not address
testing strategies.
---------------------------------------------------------------------------

    \1\ See the ICH guidance ``M3(R2) Nonclinical Safety Studies for
the Conduct of Human Clinical Trials and Marketing Authorization for
Pharmaceuticals,'' available on the Internet at http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
---------------------------------------------------------------------------

    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the Agency's current thinking on this topic.
It does not create or confer any rights for or on any person and does
not operate to bind FDA or the public. An alternative approach may be
used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management (see ADDRESSES) between 9 a.m. and 4 p.m., Monday through
Friday.

III. Electronic Access

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

    Dated: January 29, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02296 Filed 2-1-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 159 (Wednesday, August 17, 2016)]
[Notices]
[Pages 54915-54916]
[FR Doc No: 2016-19604]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Ninety-Sixth Meeting Special Committee 159 Global Positioning
System

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: NINETY-SIXTH MEETING Special Committee 159 Global Positioning
System.

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

SUMMARY: The FAA is issuing this notice to advise the public of a
meeting of NINETY-SIXTH MEETING Special Committee 159 Global
Positioning System.

DATES: The meeting will be held October 14-21, 2016, 09:00 a.m.-5:00
p.m. (unless stated otherwise)

ADDRESSES: The meeting will be held at: RTCA Conference Rooms, 1150
18th NW., Suite 910, Washington, DC.

FOR FURTHER INFORMATION CONTACT: Rebecca Morrison at<EMAIL_ADDRESS>or<PHONE_NUMBER>, or The RTCA Secretariat, 1150 18th Street NW., Suite
910, Washington, DC 20036, or by telephone at<PHONE_NUMBER>, fax at
(202) 833-9434, or Web site at http://www.rtca.org.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of the NINETY-SIXTH MEETING Special
Committee 159 Global Positioning System. The agenda will include the
following:

Specific Working Group Sessions

Friday October 14, 2016
 Morning Teleconference--10:00 a.m.--Working group 2A, GPS/
GLONASS, Webex. Contact Rebecca Morrison for details

Monday October 17, 2016
 All Day-9:00 a.m.-5:00 p.m., Working Group 2, GPS/WAAS, 9th
Floor NBAA/Colson Room

Tuesday October 18, 2016
 All Day--9:00 a.m.-5:00 p.m., Working Group 2C, GPS/Inertial,
9th Floor A4A/ARINC Room
 All Day--9:00 a.m.-5:00 p.m., Working Group 4, GPS/Precision
Landing, 9th Floor NBAA/Colson
 Half Day--9:00 a.m.-12:00 p.m., Working Group 2, GPS/WAAS, 9th
Floor NBAA/Colson Room
 Half Day--1:00 p.m.-5:00 p.m., Working Group 2A, GPS/GLONASS,
4th Floor Small Board Room

Wednesday October 19, 2016
 All Day 9:00 a.m.-5:00 p.m., Working Group 2A, GPS/GLONASS,
4th Floor Small Board Room
 All Day--9:00 a.m.-5:00 p.m., Working Group 2C, GPS/Inertial,
9th Floor ARINC/A4A Room
 All Day--9:00 a.m.-5:00 p.m., Working Group 4, GPS/Precision
Landing, 9th Floor NBAA/Colson Room

Thursday October 20, 2016
 Morning--9:00 a.m.-12:00 p.m., Working Group 2C, GPS/Inertial,
9th Floor ARINC/A4A Room
 All Day--9:00 a.m.-5:00 p.m., Working Group 4, GPS/Precision
Landing, 9th Floor NBAA/Colson
 Morning--9:00 a.m.-12:00 p.m., Working Group 7, GPS/Antennas,
4th Floor Large Board Room
 Afternoon--1:00 p.m.-5:00 p.m., Working Group 6, GPS/
Interference, 4th Floor Large Board Room

Friday October 21, 2016

 PLENARY SESSION--SEE AGENDA BELOW--starting at 9:00 a.m. 9th
Floor NBAA

    1. Introductory Remarks: DFO, RTCA and Chairman.
    2. Approval of Summary of the Ninety-Fifth Meeting held March,
2016, RTCA Paper No. 189-16/SC159-1050.

    3. Final Review and Comment (FRAC) activities.

a. DO-229E Update
b. GPS/GLONASS MOPS

    4. Review Working Group (WG) Progress and Identify Issues for
Resolution.

a. GPS/WAAS (WG-2)
b. GPS/GLONASS (WG-2A)
c. GPS/Inertial (WG-2C)
d. GPS/Precision Landing Guidance (WG-4)
e. GPS/Interference (WG-6)
f. GPS/Antennas (WG-7)

    5. Review of EUROCAE Activities.
    6. Action Item Review.

a. DME Interference to GNSS signals in the future
b. Draft formal communication to SBAS providers and other standards
bodies informing them of SC-159 work products and efforts

    7. Assignment/Review of Future Work.
    8. Other Business.
    9. Date and Place of Next Meeting.
    10. Adjourn.
    Attendance is open to the interested public but limited to space
availability. With the approval of the chairman, members of the public
may present oral statements at the meeting. Persons wishing to present
statements or obtain information should contact the person listed in
the FOR FURTHER INFORMATION CONTACT section. Members of the public may
present a written statement to the committee at any time.

    Issued in Washington, DC, on August 12, 2016.
Mohannad Dawoud,
Management & Program Analyst, Partnership Contracts Branch, ANG-A17
NextGen, Procurement Services Division, Federal Aviation
Administration.
[FR Doc. 2016-19604 Filed 8-16-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 53 (Friday, March 18, 2022)]
[Notices]
[Pages 15421-15422]
[FR Doc No: 2022-05769]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-RCRA-2007-0932, FRL-9675-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Management Standards for Hazardous Waste
Pharmaceuticals (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Management Standards for
Hazardous Waste Pharmaceuticals (EPA ICR Number 2486.03, OMB Control
Number 2050-0212) 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, 2022. Public comments were previously requested via the
Federal Register on October 12, 2021 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 18,
2022.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-RCRA-
2007-0932, online using www.regulations.gov (our preferred method) or
by mail to: EPA Docket Center, Environmental Protection Agency, Mail
Code 2821T, 1200 Pennsylvania Ave. NW, Washington, DC 20460. 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.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Kristin Fitzgerald, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address:
[email protected].

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. For further information and updates on EPA Docket
Center services, please visit us online at https://www.epa.gov/dockets.
The telephone number for the Docket Center is<PHONE_NUMBER>.
    Abstract: Some pharmaceuticals are regulated as hazardous waste
under the Resource Conservation and Recovery Act (RCRA) when discarded.
In 2019 EPA promulgated regulations for the management of hazardous
waste pharmaceuticals by healthcare facilities and reverse distributors
(84 FR 5816, February 22, 2019). Healthcare facilities (for both humans
and animals) and reverse distributors now manage their hazardous waste
pharmaceuticals under a new set of sector-specific standards in lieu of
the existing hazardous waste generator regulations. These regulations
are found in 40 CFR 266, subpart P, and are mandatory. The new
requirements include labeling containers holding non-creditable
hazardous waste pharmaceuticals and evaluated hazardous waste
pharmaceuticals with the words ``Hazardous Waste Pharmaceuticals''.
Healthcare facilities and reverse distributors must also track or
manage rejected shipments by sending a copy of the manifest to the
designated facility that returned or rejected the shipment.
Additionally, healthcare facilities and reverse distributors must
submit exception reports for a missing copy of a manifest. Reverse
distributors are required to amend their contingency plan under 40 CFR
262 subpart M. A reverse distributor must submit an unauthorized
hazardous waste report if it receives waste it is not authorized to
receive.
    Form Numbers: None.
    Respondents/affected entities: Entities potentially affected by
this action are the private sector.
    Respondent's obligation to respond: Mandatory (RCRA Section 3001).
    Estimated number of respondents: 8,163.
    Frequency of response: Annual.
    Total estimated burden: 40,045 hours per year. Burden is defined at
5 CFR 1320.03(b).
    Total estimated cost: $3,580,140 (per year), includes $0 annualized
capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 3,532 hours
compared to the currently approved ICR due to a decrease in the
universe. The universe estimates are based on real data for this
renewal.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-05769 Filed 3-17-22; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 82, Number 183 (Friday, September 22, 2017)]
[Notices]
[Pages 44426-44427]
[FR Doc No: 2017-20240]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-0001]

Vaccines and Related Biological Products Advisory Committee;
Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Vaccines and Related
Biological Products Advisory Committee (VRBPAC). The general function
of the committee is to provide advice and recommendations to the Agency
on FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will be held on November 7, 2017, from 8:30 a.m. to
5 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993-
0002. For those unable to attend in person, the meeting will also be
webcast and will be available at the following link: https://collaboration.fda.gov/cbervrbpac2017. Answers to commonly asked
questions including information regarding special accommodations due to
a disability, visitor parking, and transportation may be accessed at:
https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Serina Hunter-Thomas, Center for
Biologics Evaluation and Research, Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 71, Rm. 6307C, Silver Spring, MD 20993-0002,
240-402-5771<EMAIL_ADDRESS>or Rosanna Harvey,
Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 6336, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area). A notice in the Federal Register about last
minute

modifications that impact a previously announced advisory committee
meeting cannot always be published quickly enough to provide timely
notice. Therefore, you should always check the Agency's Web site at
https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to
the appropriate advisory committee meeting link, or call the advisory
committee information line to learn about possible modifications before
coming to the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: On November 7, 2017, the committee will meet in an open
session to discuss and make recommendations on the clinical development
plan for Pfizer's investigational Staphylococcus aureus vaccine
intended for pre-surgical prophylaxis in elective orthopedic surgical
populations.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 31, 2017. Oral presentations from the public will be scheduled
between approximately 1:15 p.m. and 2:15 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and addresses
of proposed participants, and an indication of the approximate time
requested to make their presentation on or before October 23, 2017.
Time allotted for each presentation may be limited. If the number of
registrants requesting to speak is greater than can be reasonably
accommodated during the scheduled open public hearing session, FDA may
conduct a lottery to determine the speakers for the scheduled open
public hearing session. The contact person will notify interested
persons regarding their request to speak by October 24, 2017.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Serina Hunter-Thomas at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 15, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-20240 Filed 9-21-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 16 (Thursday, January 24, 2013)]
[Rules and Regulations]
[Pages 5140-5143]
[FR Doc No: 2013-00579]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R08-OAR-2011-1025, FRL-9762-5]

Approval and Promulgation of Air Quality Implementation Plans;
Colorado; Revisions to New Source Review Rules

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is taking final action to approve revisions adopted by the
State of Colorado on December 15, 2005, to Regulation No. 3 (Air
Pollutant Emission Notice and Permitting Requirements). Colorado
submitted the request for approval of these rule revisions into the
State Implementation Plan (SIP) on August 21, 2006. The revisions
remove repealed provisions in Regulation No. 3 that pertain to the
issuance of Colorado air quality permits; the revisions also implement
other minor administrative changes and renumbering. The intended effect
of this action is to take final action to approve the rules that are
consistent with the Clean Air Act (CAA.) This action is being taken
under section 110 of the CAA.

DATES: This final rule is effective February 25, 2013.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R08-OAR-2011-1025. All documents in the docket are listed in
the www.regulations.gov Web site. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in www.regulations.gov or in hard copy at the Air Program,
Environmental Protection Agency (EPA), Region 8, 1595 Wynkoop Street,
Denver, Colorado 80202-1129. EPA requests you contact the individual
listed in the FOR FURTHER INFORMATION CONTACT section to view the hard
copy of the docket. You may view the hard copy of the docket Monday
through Friday, 8:00 a.m. to 4:00 p.m., excluding Federal holidays.

FOR FURTHER INFORMATION CONTACT: Kevin Leone, Air Program, Mailcode 8P-
AR, Environmental Protection Agency, Region 8, 1595 Wynkoop Street,
Denver, Colorado 80202-1129,<PHONE_NUMBER>, or<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background Information
II. Response to Comments
III. What are the changes EPA is taking final action to approve?
IV. What action is EPA taking today?
V. Statutory and Executive Order Reviews

Definitions

    For the purpose of this document, we are giving meaning to certain
words or initials as follows:
    (i) The words or initials Act or CAA mean or refer to the Clean Air
Act, unless the context indicates otherwise.
    (ii) The words EPA, we, us or our mean or refer to the United
States Environmental Protection Agency.
    (iii) The initials SIP mean or refer to State Implementation Plan.
    (iv) The words State or Colorado mean the State of Colorado, unless
the context indicates otherwise.

I. Background Information

    On December 31, 2002, EPA published revisions to the federal
Prevention of Significant Deterioration (PSD) and non-attainment NSR
regulations. These revisions are commonly referred to as ``NSR Reform''
and became effective nationally in areas not covered by a SIP on March
3, 2003. The NSR Reform revisions included provisions for baseline
emissions determinations, actual-to-future actual methodology,
plantwide applicability limits (PALs), clean units, and pollution
control projects (PCPs). On June 24, 2005, the United States Court of
Appeals for the District of Columbia Circuit issued its decision and
opinion in the case of New York v. U. S. Environmental Protection
Agency, 413 F.3d 3 (D.C. Cir. 2005). The court concluded that,
regarding the clean unit exemption from NSR, the plain language of the
Clean Air Act indicated that Congress intended to apply NSR to changes
that increase actual emissions instead of potential or allowable
emissions. As a result, the court vacated the clean units portions of
the Federal Rule. The court also concluded that EPA lacks the authority
to create pollution control project exemptions from NSR and vacated the
PCP portions of both the 1992 WEPCO Rule and the 2002 NSR Reform rule.
By vacating those portions of the Federal NSR rule, the court
terminated those exemptions to new source review. The court also
remanded back to EPA the ``reasonable possibility'' standard for when a
source must keep certain project related records.
    The State of Colorado submitted a formal SIP revision on July 11,
2005, followed by a supplemental submittal on October 25, 2005. These
submittals requested approval for regulations to implement the NSR
Reform provisions that were not vacated or remanded by the June 24,
2005 court decision; including renumbering, reorganizing, and revised
definitions. On April 10, 2012 (77 FR 21453), EPA published a notice of
final rulemaking for the July 11, 2005, and October 25, 2005
submittals. In that action, EPA approved renumbering, reorganizing and
portions of Colorado's revisions to the Stationary Source Permitting
and Air Pollutant Emission Notice Requirements (Regulation No. 3) that
incorporate EPA's December 31, 2002 NSR Reform; however, EPA considered
as withdrawn the portions of the submittals that implemented the clean
unit and pollution control project exemptions. EPA also approved a
version of the recordkeeping requirements that removed the ``reasonable
possibility'' standard.
    Colorado adopted revisions on December 15, 2005, and submitted
these revisions, which we are addressing in this action, on August 21,
2006. These revisions reflect the removal of references to clean units,
pollution control projects, and the ``reasonable possibility'' standard
from the State's rules. As a result of the deletion of these
references, many provisions were renumbered and references to them

updated. The submittal also included other minor administrative changes
to Regulation No. 3.
    Colorado's August 21, 2006 submittal supersedes the portions of the
Colorado's July 11, 2005 and October 25, 2005, submittals which were
considered withdrawn in our April 10, 2012 action. EPA is taking final
action on these revisions in this rulemaking.

II. Response to Comments

    EPA proposed action on these revisions on July 9, 2012 (77 FR
40315.) We accepted comments from the public on this proposal through
August 8, 2012. EPA received no comments during the public comment
period.

III. What are the changes EPA is taking final action to approve?

    EPA is taking final action to approve all revisions to Regulation
No. 3 as submitted on August 21, 2006, with one exception, including
renumbering that resulted from removing provisions that were vacated or
remanded in the June 24, 2005 court decision, as well as minor
administrative changes. We are not approving the removal of provisions
that were considered withdrawn in our April 10, 2012 action (77 FR
21453), as these provisions were never approved into the SIP. We are
only approving the renumbering that resulted from Colorado's removal of
those provisions from Regulation Number 3. In a number of instances,
the provisions that were approved in our April 10, 2012 action contain
italicized and underlined text. As explained in our April 10, 2012
notice, the italicized text was to be added to the SIP and the
underlined text removed from the SIP upon our approval of the NSR
reform provisions. As that approval was completed in our April 10, 2012
action, in this action we incorporate only the plain and italicized
text of the renumbered provisions.
    The exception stems from a final action EPA took on January 9, 2012
(77 FR 1027). In that action, we approved revisions to Regulation
Number 3, Part C, that were submitted on August 1, 2007 to meet the
requirements of the Phase 2 Implementation Rule for the 1997 ozone
NAAQs (70 FR 71612, Nov. 29, 2005). As the August 1, 2007 submittal was
subsequent to the August 21, 2006 submittal we are approving today, the
provisions we approved in our January 9, 2012 action (listed in Table 2
of 77 FR 1027) already reflect the renumbering of Part C and supersede
the provisions in the August 21, 2006 submittal. As explained in our
January 9, 2012 notice, the subsequent approval of the remaining
renumbering of Part C--which we are carrying out today--resolves any
discrepancy in the numbering of Part C.
    As part of the NSR Reform rule, EPA allowed sources to calculate
their actual and projected actual emissions to determine whether a
modification will trigger NSR. If a source concludes that there is no
``reasonable possibility'' that emissions from a project will trigger
NSR, the source is not required to keep records substantiating that
calculation. However, the data and records would necessarily be
generated by the owner or operator to calculate its emissions.
    Colorado did not follow the federal rule in this regard. In Section
I.B.5., Colorado imposes a requirement that owners or operators using
the actual-to-projected-actual applicability test for a project that
requires a minor source permit or modification [pursuant to Part A,
Section I.B.26.; Part C, Section I.A.3.; or Part C, Section X.; or any
minor source permit under any provisions of Part B], submit an
otherwise-required permit application and include documentation
adequate to substantiate calculations made for the test.
    The June 24, 2005, DC Circuit court opinion also addressed the
recordkeeping and reporting requirements of the federal rule. The 2002
rule excused a source from maintaining records of the information and
calculations used in the actual-to-projected actual applicability test
if the source determined that there was no ``reasonable possibility''
that the modification would trigger NSR. These are the same records
necessary to substantiate calculations made for the applicability test.
The court concluded that lack of evidence, in the form of data and
records, could inhibit enforceability of the NSR program in this
context. The court remanded this part of the rule. On December 21,
2007, EPA published a final rule in response to the DC Circuit Court's
remand of the recordkeeping provisions of EPA's 2002 NSR Reform Rules
(see 72 FR 72607) in which EPA clarified what constitutes ``reasonable
possibility''. 72 FR 72607 established a ``percentage increase
trigger'' by which there is a reasonable possibility that a change
would result in a significant emissions increase if the projected
emissions increase of a pollutant--determined by comparing baseline
actual emissions to projected actual emissions--equaled or exceeded
fifty percent of the applicable NSR significant level for that
pollutant.
    The State of Colorado requires sources retain records that, among
other things, are essential to substantiate sources' calculations using
the actual-to-projected-actual applicability test. Colorado also
requires that a source submit its data and calculations along with a
permit application that would otherwise be required for the physical or
operational change. Colorado reviews the data and calculations only to
confirm a source's conclusions whether it triggers NSR. The information
submitted is then included in a non-enforceable appendix to a source's
Title V Permit or as a permit note in the source's construction permit.
Accordingly, Colorado elected not to modify Part D, Section I.B.5. and
to modify Part D, Sections V.A.7.c. and VI.B.5. in a manner that
maintains consistency with Section I.B.5. Part D, Sections V.A.7.c. and
VI.B.5 were previously approved in 77 FR 21453 (April 10, 2012). EPA
finds that the current Regulation No. 3 recordkeeping requirements are
at least as stringent as in 72 FR 72607.

IV. What action is EPA taking today?

    Based on the discussion in this notice, EPA finds that the
renumbering resulting from Colorado's removal of vacated and remanded
provisions from the June 24, 2005, court decision, and other minor
administrative changes meet applicable requirements of the Act; and
thus, the revisions are approvable under CAA section 110. Therefore, we
are taking final action to approve Colorado's Regulation No. 3
revisions as submitted on August 21, 2006.
    Specifically, we are taking final action to approve the
renumbering--with the exception of renumbered provisions already
approved in our January 9, 2012 action--resulting from the deletion of
the following provisions:\1\
---------------------------------------------------------------------------

    \1\ The provisions approved in our January 9, 2012 action are
Regulation Number 3, Part C, Sections II.A.22.a, II.A.24.d,
II.A.38.c, and II.A.42.a. Also, in our proposal for this action we
proposed to delete Part A, Sections V.E.10 and V.E.11, and Part C,
Section I.A.7.j from the SIP. However, these provisions were never
approved into the SIP so deletion of them is unnecessary. The
deletion of Part A, Sections V.E.10 and V.E.11 did not cause any
renumbering; however, the deletion of Part C, Section I.A.7.j did
cause renumbering and we are approving the renumbered sections.

Part C, Section I.A.7.j
Part D, Section II.A.23.d.(viii)
Part D, Section II.A.27.c.(iv)
Part D, Section II.A.27.g.(v)
Part D, Section I.B.3.
Part D, Section I.D.
Part D, Section II.A.11.
Part D, Section II.A.35.
Part D, Section XV.
Part D, Section XVI.

    We are approving the renumbering of the existing Regulation No. 3
rule because these changes are non-substantive and do not affect the
meaning of the rule. The renumbering

changes are outlined in the August 21, 2006 state submittal (see
docket).

V. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this final action merely approves state law as meeting
Federal requirements and does not impose additional requirements beyond
those imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by March 25, 2013. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds, Incorporation
by reference.

    Dated: November 27, 2012.
Howard M. Cantor,
Acting Regional Administrator, Region 8.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart G--Colorado

0
2. Section 52.320 is amended by adding paragraph (c)(125) to read as
follows:

Sec.  52.320  Identification of plan.

* * * * *
    (c) * * *
    (125) On August 21, 2006, the State of Colorado submitted revisions
to 5 CCR 1001-5, Regulation Number 3, Air Pollution Emission Notice and
Permitting Requirements. The August 21, 2006, submittal included
renumbering and deletions of Regulation Number 3. The incorporation by
reference in paragraphs (c)(125)(i)(A) and (B) of this section reflect
the renumbered sections, deletions and reference changes as of the
August 21, 2006, submittal.
    (i) Incorporation by reference
    (A) 5 CCR 1001-5, Regulation Number 3, Stationary Source Permitting
and Air Contaminant Emission Notice Requirements, Part C, Concerning
Operating Permits, Section I, Applicability, I.A., Definitions;
I.A.7.j., adopted December 15, 2005 and effective March 2, 2006.
    (B) 5 CCR 1001-5, Regulation Number 3, Stationary Source Permitting
and Air Contaminant Emission Notice Requirements, Part D, Concerning
Major Stationary Source New Source Review and Prevention of Significant
Deterioration, adopted December 15, 2005 and effective March 2, 2006:
    (1) Section I, Applicability, I.A., General Applicability; I.A.2.,
I.B., Applicability Tests; I.B.3., I.B.4.
    (2) Section II, Definitions; II.A.; II.A.1., Actual Emissions;
II.A.1.d.; II.A.11., Complete; II.A.12., Construction; II.A.13.,
Emissions Unit; II.A.14., Electric Utility Steam Generating Unit;
II.A.15., Federal Land Manager (FLM); II.A.16., High Terrain; II.A.17.,
Hydrocarbon combustion flare; II.A.18., Innovative Control Technology;
II.A.19., Low Terrain; II.A.20., Lowest Achievable Emission Rates
(LAER) (excluding underlined text); II.A.21., Major Emissions Unit;
II.A.22., Major Modification (excluding II.A.22.a. and underlined
text); II.A.23., Major Source Baseline Date; II.A.24., Major Stationary
Source (excluding II.A.24.d. and underlined text); II.A.25., Minor
Source Baseline Date; II.A.26., Net Emissions Increase (excluding
underlined text); II.A.27., Nonattainment Major New Source Review (NSR)
Program; II.A.28., PAL Effective Date; II.A.29., PAL Effective Period;
II.A.30., PAL Major Modification; II.A.31., PAL Permit; II.A.32., PAL
Pollutant; II.A.33., Plantwide Applicability Limitation (PAL);
II.A.34., Prevention of Significant Deterioration (PSD) Permit;
II.A.35., Project; II.A.36., Projected Actual Emissions; II.A.37.,
Reactivation of Very Clean Coal-fired Electric Utility Steam Generating
Unit; II.A.38., Regulated

NSR Pollutant (excluding II.A.38.c.); II.A.39., Replacement Unit;
II.A.40., Repowering (excluding underlined text); II.A.41., Secondary
Emissions; II.A.42., Significant (excluding II.A.42.a.) ; II.A.43.,
Significant Emissions Increase; II.A.44., Significant Emissions Unit;
II.A.45., Small Emissions Unit; II.A.46., Temporary Clean Coal
Technology Demonstration Project; XV., Actual PALs.
    (ii) Additional material.
    (A) Notice of Final Adoption, dated 12/15/2005, signed by Douglas
A. Lempke, Administrator, for revisions made to Regulation Number 3,
Air Pollution Emission Notice and Permitting Requirements.

[FR Doc. 2013-00579 Filed 1-23-13; 8:45 am]
BILLING CODE 6560-50-P