SUPPORTING STATEMENT FOR EPA INFORMATION COLLECTION REQUEST NUMBER 1189.10 REPORTING AND RECORDKEEPING REQUIREMENTS FOR THE PROPOSED RULE ON CATHODE RAY TUBES November 2001 Table of Contents 1. IDENTIFICATIONOFTHE INFORMATIONCOLLECTION ............. Page2 1( a) Title and Number of Information Collection ....................... Page2 1( b) Characterization of the Information Collection ..................... Page2 2. NEEDFORANDUSE OFTHECOLLECTION ........................ Page3 2( a) Need and Authority for the Collection ........................... Page3 2( b) Use and Users of the Data .................................... Page3 3. RESPONDENTS AND THE INFORMATION REQUESTED .............. Page3 3( a) Respondents and SIC Codes ................................... Page3 3( b) Information Requested ....................................... Page6 4. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT .............. Page7 4( a) Agency Activities ........................................... Page8 4( b) Small Entity Flexibility ....................................... Page8 5. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA .............................................................. Page8 5( a) Non duplication ............................................ Page8 5( b) Consultations .............................................. Page8 5( c) Effects of Less Frequent Collection ............................. Page8 5( d) General Guidelines .......................................... Page9 5( e) Confidentiality ............................................. Page9 5( f) Sensitive Questions .......................................... Page9 6. ESTIMATINGTHE BURDENANDCOSTOFCOLLECTION ............ Page9 6( a) Estimating Respondent Burden ................................. Page9 6( b) Number of Respondents ...................................... Page9 6( c) Estimating Respondent Costs ................................. Page13 6( d) Reasons for Change in Burden ................................ Page13 6( e) Burden Statement .......................................... Page16 LIST OF TABLES Table1 EstimatedNumber ofCRTShipments .............................. 11 Table 2 Reporting and Recordkeeping Requirements for Used CRT Regulated Entities: AnnualEstimatedRespondentBurdenandCost ....................... 12 Table 3 Reporting and Recordkeeping Requirements for Used CRT Generators and Processors: Annual Respondent Burden and Cost Summary (All Respondents) 14 Table4 AverageandTotalAnnualAvoidedRespondentBurden( Hours) .......... 15 Table5 AverageAnnualBurdenper Respondent( Hours) ...................... 16 i Page 1 1. IDENTIFICATION OF THE INFORMATION COLLECTION A. Background 1( a) Title and Number of Information Collection This Information Collection Request (ICR) is entitled "Reporting and Recordkeeping Requirements for the Proposed Rule on Cathode Ray Tubes, Number 1189.10. .

1( b) Characterization of the Information Collection Section 3001 of the Resource Conservation and Recovery Act (RCRA) of 1976, as amended, requires the Environmental Protection Agency (EPA) to identify substances that must be managed as hazardous waste during treatment, storage, or disposal. Under this authority, EPA established four hazardous waste characteristics (toxicity, reactivity, ignitability, and corrosivity), and listed specific wastes that must be managed as hazardous. Used cathode ray tube (CRT) glass often is hazardous because it exhibits the characteristic of toxicity by exceeding the regulatory level for lead. As a result, currently many CRTs are subject to controls under RCRA Subtitle C hazardous waste regulations.

From 1994 through 1998, EPA's Common Sense Initiative (CSI) Council explored the environmental regulation of six industry sectors and looked for ways to make environmental regulation "cleaner, cheaper, and smarter." EPA established the CSI Council as an advisory committee under the Federal Advisory Committee Act. The CSI Council included representatives from each of the industry sectors, from non government environmental and community organizations, from state government, and from academia. EPA also established a subcommittee of the Council for each of the industry sectors that included representatives of the various stakeholders represented in the CSI Council. One of the industry sectors selected for this initiative was the computer and electronics industry. The CSI Computers and Electronics Subcommittee (CES) set up a workgroup to address regulatory barriers to pollution prevention and recycling. The "Overcoming Barriers Workgroup," explored the problems of managing mounting volumes of outdated computer and electronics equipment.

One of the concerns investigated by the Overcoming Barriers Workgroup and the CES Subcommittee was the barrier to CRT glass recycling created by some existing hazardous waste management regulations. The Subcommittee stated that removing this barrier was essential to fostering CRT recycling, especially glass to glass recycling. As a result of the finding of the CES Subcommittee, the CSI Council issued a document titled Recommendation on Cathode Ray Tube (CRT) Glass to Glass Recycling. Page 2 To encourage CRT glass recycling and improve the management of hazardous waste CRTs, EPA is excluding used CRTs and processed CRT glass sent for recycling from the definition of solid waste, subject to certain minimal conditions. The Agency believes these materials resemble articles in commerce more than wastes when handled appropriately. By excluding used CRTs and processed CRT glass that are to be recycled from the definition of solid waste, the proposal streamlines management requirements for these materials. The streamlined requirements will lead to better management and more recycling while affording full protection to human health and the environment.

B. Introduction Most of the proposal's information collection requirements consist of recordkeeping. EPA is not proposing any permitting requirements for entities recycling used CRTS or processed CRT glass. Following is a brief description of the proposal's information collection requirements. It should be noted that this ICR does not examine the burden or cost associated with the generation and management of hazardous waste CRTs or processed CRT glass that is destined for disposal. This category of CRTs continues to be considered hazardous waste and must be managed in accordance with the existing Subtitle C requirements.

Marking Broken used CRTs destined for recycling must be clearly labeled or marked. Processed CRT glass need not be labeled and marked, unless it is going to a recycler other than a glass toglass manufacturer or a lead smelter. These requirements are necessary in order to identify and distinguish used CRTs and processed CRT glass from other materials and to prevent inadvertent mixing with other wastes.

Storage Time Limits Broken used CRTs and processed CRT glass, in order to be excluded from the definition of solid waste, may not be speculatively accumulated.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need and Authority for the Collection The requirements covered in this ICR are necessary for EPA to ensure proper management of used CRTs and processed CRT glass and to facilitate enforcement of the regulations. Page 3 2( b) Use and Users of the Data EPA will use the collected information to ensure that used CRTs and processed CRT glass are being managed in a protective manner. Information marked on containers with broken used CRTs or processed CRT glass will assist handlers, processors, and transporters in ensuring proper management during storage and shipment.

3. RESPONDENTS AND THE INFORMATION REQUESTED 3( a) Respondents and SIC Codes The following is a list of Standard Industrial Classification (SIC) codes associated with entities handling CRTs likely to be affected by the information collection requirements covered under this ICR:

SIC Code * Industry *

AGRICULTURE 7 Agricultural services 8 Forestry 9 Fishing, hunting, trapping  Administrative & auxiliary MINING 10 Metal mining 12 Coal mining 13 Oil & gas extraction 14 Non metallic minerals, except fuels  Administrative & auxiliary CONSTRUCTION 15 General contractors 16 Heavy construction 17 Special trade contractors 1 Administrative & auxiliary MANUFACTURING 20 Food & kindred products 21 Tobacco products 22 Textile mill products 23 Apparel & other textile products 24 Lumber & wood products 25 Furniture & fixtures SIC Code * Industry *

Page 4 26 Paper & allied products 27 Printing & publishing 28 Chemicals & allied products 29 Petroleum and coal products 30 Rubber & miscellaneous plastics products 31 Leather & leather products 32 Stone, clay, and glass products 33 Primary metal industries 34 Fabricated metal products 35 Industrial machinery & equipment 36 Electronic & other electronic equipment 37 Transportation equipment 38 Instrument & related products 39 Miscellaneous manufacturing 1 Administrative & auxiliary TRANSPORTATION 41 Local & interurban passenger transit 42 Trucking & warehousing 44 Water transportation 45 Transportation by air 46 Pipelines, except natural gases 47 Transportation services 48 Communication 49 Electronic, gas, & sanitary services 1 Administrative & auxiliary WHOLESALE TRADE 50 Wholesale trade durable goods 51 Wholesale trade nondurable goods 52 Bldg. materials & garden supplies 1 Administrative & auxiliary RETAIL TRADE 53 General merchandise store 54 Food stores 55 Auto dealers & service station 56 Apparel & accessory stores 57 Furniture & home furnishing stores SIC Code * Industry *

Page 5 58 Eating & drinking places 59 Miscellaneous retail 1 Administrative & auxiliary FINANCE, INSURANCE, AND REAL ESTATE 60 Depository institution 61 Nondepository institution 62 Security & commodity brokers 63 Insurance carriers 64 Insurance agents, brokers, & servicers 65 Real estate 67 Holding & other investment offices 1 Administrative & auxiliary SERVICES 70 Hotels & other lodging places 72 Personal services 73 Business services 75 Auto repair, services, & parking 76 Misc. repair services 78 Motion picture 79 Amusement & recreation services 80 Health services 81 Legal services 82 Educational services 83 Social services 84 Museums, botanical, zoological gardens 86 Membership organization 87 Engineering & management service 89 Services 1 Administrative & auxiliary 1 Unclassified * Source: U. S. Bureau of the Census (1992). Includes County Business Patterns data and data from the Enterprise Statistics Program. Page 6 3( b) Information Requested This section describes information collection requirements applicable to CRT regulated entities that would be affected by the proposed rule.

Marking (i) Data items:

Generators of broken used CRTs sent for recycling, and generators of processed CRT glass sent for any kind of recycling other than a glass to glass manufacturer or a lead smelter, must mark or label their broken used CRTs and processed CRT glass in accordance with the following procedures:

 Each container or package with broken used CRTs must be labeled or marked clearly with one of the following phrases: "Used cathode ray tube( s)  contains leaded glass," or "Used cathode ray tube( s)  contains leaded glass." In addition, it must also be labeled: "Do not mix with other glass or materials."

(ii) Respondent Activities:

 Generators and processors must mark or label containers with broken used CRTs or processed CRT glass.

Storage Time Limits (i) Data items:

Broken used CRTs and processed CRT glass may not be accumulated speculatively. Generators and processors are required to demonstrate the length of time that the CRT materials have been accumulated from the date it was received or became a waste. The demonstration may be made by using any of the following methods:

 Placing the broken used CRTs in a container and marking the container with the earliest date that any CRT in the container became a waste or was received.

 Marking each individual broken CRT with the date it became a waste or was received.

 Maintaining an inventory system on site that identifies the date the broken CRTs being accumulated became wastes or were received.

 Maintaining an inventory system on site that identifies the earliest date any broken CRT in a group of CRT items or a group of containers of CRTs became a waste or was received.

 Placing the broken CRTs in a specific accumulation area and identifying the Page 7 earliest date that any CRT material in the area became a waste or was received.

 Any other method which clearly demonstrates the length of time that the broken CRTs has been accumulated from the date it became a waste or was received.

(ii) Respondent Activities:

 Generators and processors must demonstrate the length of time that broken CRTs has been accumulated since it became a waste or was received.

4. THE INFORMATION COLLECTED  AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT The following section discusses how EPA and implementing agencies would collect and manage the information received from respondents. This section also includes a discussion of the steps EPA will take to ensure that the information collection is not overly burdensome on small entities.

4( a) Agency Activities The information that is required of CRT generators and processors would be kept on site and not submitted to EPA formally. Therefore, there are no follow up activities by the Agency in response to this information.

4( b) Small Entity Flexibility By excluding hazardous waste CRTs and processed CRT glass intended for recycling from the definition of solid waste under certain minimal conditions, the proposed rule provides regulatory relief from the full Subtitle C management requirement for all entities involved in CRT management and willing to recycle CRT glass. These entities include generators, CRT recycling facilities, and CRT glass manufacturers.

EPA believes this exclusion will encourage small businesses to safely manage broken CRTs or processed CRT glass in compliance with the proposed rule. In addition, EPA allows conditionally exempt small quantity generators (CESQGs) to manage their hazardous waste CRTs either under the existing CESQG exemption in 40 CFR 261.5 or under the specific provisions of the proposed rule. Page 8 5. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 5( a) Non duplication Most of the information required by the proposed regulations covered by this ICR is not available from any source but the respondents. Some of the respondents may be able to use current facility records and practices to comply with the labeling, marking and storage requirements. In addition, the proposal relieves affected CRT entities from RCRA's current information collection requirements.

5( b) Consultations For more than two years, EPA has worked on a collaborative basis with the Computers and Electronics Sector of the CSI Council in developing the proposed CRT standards. This workgroup consisted of representatives of environmental groups, industry trade associations, CRT glass manufacturers, CRT glass recyclers, electronics Original Equipment Manufacturers (OEMs), academic experts, States (California, Massachusetts, Minnesota, and New Jersey), EPA, and expert consultants in the environmental, legal/ regulatory, worker health and safety, and environmental justice issues. In addition, EPA will consider public comments submitted in response to the proposed rulemaking prior to promulgating the final rule.

5( c) Effects of Less Frequent Collection EPA will consider carefully the burden imposed upon the regulated community by the proposed regulations, and to the extent possible, will attempt to minimize the burden imposed. EPA believes strongly that if the minimum requirements specified under the proposed regulations are not met, neither the facilities nor EPA will be able to ensure that used CRTs are being managed in a manner protective of human health and the environment.

5( d) General Guidelines This ICR adheres to the guidelines stated in the 1995 Paperwork Reduction Act, OMB's implementing regulations, OMB's Information Collection Review Handbook, and other applicable OMB guidance.

5( e) Confidentiality Section 3007( b) of RCRA and 40 CFR Part 2, Subpart B, which define EPA's general policy on public disclosure of information, contain provisions for confidentiality. The information provided by the entities regulated under the proposed regulations will be treated in accordance with these provisions, as appropriate. Page 9 5( f) Sensitive Questions No questions of a sensitive nature are included in any of the information collection requirements.

6. ESTIMATING THE BURDEN AND COST OF COLLECTION 6( a) Estimating Respondent Burden This ICR presents a comprehensive characterization of the reporting and recordkeeping burden and costs to CRT generators and processors under the proposed rule.

6( b) Number of Respondents The number of facilities that would be covered by the proposed rule was obtained from EPA's "Draft Economic Analysis of Cathode Ray Tube Management, Notice of Proposed Rulemaking," dated August 24, 2001. EPA estimates that 2, 116 small quantity handlers/ collectors, 311 large quantity handlers/ collectors and 5 processors will generate CRTs or processed CRT glass that is exempt from the definition of solid waste under this rule. Further, EPA expects that each year one percent of the generators will be new generators.

Reading the Regulations EPA expects that regulated CRT entities will read the applicable waste CRT regulations as a one time activity in order to familiarize themselves with the new rule.

Marking EPA expects that all generators and processors will label packages or containers containing broken CRTs. Generators and processors are not expected to mark each individual, broken CRT, but rather accumulate them in clearly marked containers or vehicles, thus minimizing the recordkeeping burden.

Storage Time Limits EPA expects that some CRT entities will keep records on their storage time according to procedures specified in the regulations. EPA believes the remaining entities will use standard business practices. EPA estimates that 75 percent of CRT regulated entities will keep records by marking storage containers or storage areas with the earliest date that broken CRTs became a waste or were received. EPA estimates that the remaining 25 percent of CRT regulated entities will use standard business practices which account for storage time and satisfy the proposed rule requirements; these entities therefore are not burdened in this ICR.

EPA expects that the burden imposed by the proposed rule is associated with rule Page 10 familiarization and marking and labeling packages or containers with broken CRTs. Table 1 provides background data on the number of used CRT entities and shipments. Shipments are based on two per small quantity handler/ collector and four for large quantity handlers/ collectors per year. Table 2 shows the one time rule familiarization cost and the average annual burden and costs for generators, collectors, and processors to comply with each CRT requirement. The table includes estimated labor costs and operation and maintenance (O& M) costs. Table 3 summarizes, by respondent type, the total annual burden and costs.

Table 1 Estimated Number of CRT Shipments Type of Regulated Entity Number of Regulated Entities Total # of Shipments Sent Off Site Small Quantity Handlers/ Collectors 2,116 4,232 Large Quantity Handlers/ Collectors 311 1,244 Processors 5 128 Total 2,432 5,604 Page 11 TABLE 2 REPORTING AND RECORDKEEPING REQUIREMENTS FOR CRT REGULATED ENTITIES: ONE TIME COST PER ENTITY O& M Costs per Respondent Number of Respondents Hours per Respondent Postage/ Shipping Photocopies Contractor Support Hours per Respondent Cost Per Respondent Total Cost All Respondents Legal Manager Technical Clerical @

$3/ doc @ $0.10/ page @

$80.00/ hr @ $116.53/ hr @ $110.95/ h r @ $60.89/ hr @ $43.44/ hr CRT RULE FAMILIARIZATION Small Quantity Handlers/ Collectors 2,116 0.0 1. 0 1.5 0. 0 $0.00 $0.00 $0.00 2.5 $202.28 $428,024.48 Large Quantity Handlers/ Collectors 311 0.5 1. 0 1.5 0. 0 $0.00 $0.00 $0.00 3.0 $260.56 $81,034.16 Processors 5 0. 0 1.0 1. 5 0.0 $0.00 $0.00 $0.00 2.5 $202.28 $1,011.40 SUBTOTAL 2,432 0.5 3. 0 4.5 0. 0 $0.00 $0.00 $0.00 8.0 $665.12 $510,070.04 REPORTING AND RECORDKEEPING REQUIREMENT FOR CRT REGULATED ENTITIES ANNUAL ESTIMATED RESPONDENT BURDEN AND COST O& M Costs per Respondent Number of Respondents Hours per Respondent Postage/ Shipping Photocopies Contractor Support Hours Per Year Per Respondent Cost Per Year Per Respondent Total Cost Per Year Per All Respondents Legal Manager Technical Clerical @

$3/ doc @ $0.10/ page @

$80.00/ hr @ $116.53/ hr @ $110.95/ h r @ $60.89/ hr @ $43.44/ hr Mark the broken CRTs or containers Small Quantity Handlers/ Collectors 2,116 0.0 0. 0 0.5 0. 0 $0.00 $0.00 $0.00 0.5 $30.45 $64,432.20 Large Quantity Handlers/ Collectors 311 0.0 0. 0 2.0 0. 5 $0.00 $0.00 $0.00 2.5 $143.50 $44,628.50 Processors 5 0. 0 0.0 0. 5 0.0 $0.00 $0.00 $0.00 0.5 $30.45 $152.25 Page 12 SUBTOTAL 2,432 0.0 0. 0 3.0 0. 5 $0.00 $0.00 $0.00 3.5 $204.39 $109,212.95 Page 13 REPORTING AND RECORDKEEPING REQUIREMENT FOR CRT REGULATED ENTITIES ANNUAL ESTIMATED RESPONDENT BURDEN AND COST O& M Costs per Respondent Number of Respondents Hours per Respondent Postage/ Shipping Photocopies Contractor Support Hours Per Year Per Respondent Cost Per Year Per Respondent Total Cost Per Year Per All Respondents Legal Manager Technical Clerical @

$3/ doc @ $0.10/ page @

$80.00/ hr @ $116.53/ hr @ $110.95/ h r @ $60.89/ hr @ $43.44/ hr Mark storage container or area used to store CRTs or CRT glass with the date the waste was received or became a waste Small Quantity Handlers/ Collectors 2116 0.0 0. 0 0.25 0.25 $0.00 $0.00 $0.00 0.5 $26.08 $55,185.28 Large Quantity Handlers/ Collectors 311 0.0 0. 0 0.50 0.25 $0.00 $0.00 $0.00 0.75 $41.31 $12,847.41 Subtotal 2427 0.0 0. 0 0.75 0.50 $0.00 $0.00 $0.00 1.25 $67.39 $68,032.69 TOTAL ONE TIME COST PER FACILITY SQH/

Collectors 2116 0.0 1. 0 1.50 0.00 $0.00 $0.00 $0.00 6.0 $202.28 $428,024.48 LQH/

Collectors 311 0.5 1. 0 1.50 0.00 $0.00 $0.00 $0.00 3.0 $260.56 $81,034.16 Processors 5 0. 0 1.0 1.

50 0.

00 $0.00 $0.00 $0.00 2.5 $202.28 $1,011.40 TOTAL 2432 0.5 3. 0 4.50 0.00 $0.00 $0.00 $0.00 11.5 $665.12 $510,070.04 TOTAL ANNUAL ESTIMATED RESPONDENT BURDEN AND COST SQH Total 2116 0.0 0. 0 0.75 0.25 $0.00 $0.00 $0.00 1.00 $56.53 $119,617.48 LQH Total 311 0.0 0. 0 2.50 0.75 $0.00 $0.00 $0.00 3.25 $184.81 $57,475.91 Processors 5 0. 0 0.0 0.

50 0.

00 $0.00 $0.00 $0.00 0.50 $30.45 $152.25 TOTAL 2432 0.0 0. 0 3.75 1.00 $0.00 $0.00 $0.00 4.75 $271.79 $177,245.64 Page 14 6( c) Estimating Respondent Costs Labor The average annual salaries of the professionals listed in Table 2 are based on data found in the U. S. Department of Labor Statistics (BLS) "National Compensation Survey: Occupational Wages in the United States, 1997." Wages were calculated using the BLS rate with the labor multiplier. The labor rates are based on a full time employee with a 40 hour work week. Total annual respondent labor costs, summarized in the 3 rd column of Table 3, are estimated to be $510,070 for the initial one time cost and $177,245.64 for the annual variable costs.

Operation and Maintenance O& M costs are those costs associated with a paperwork requirement incurred continually over the life of the ICR. They are defined by the 1995 Paperwork Reduction Act as "the recurring dollar amount of cost associated with O& M or purchasing services." For this ICR, EPA estimates that there are no respondent O& M costs.

Capital Capital costs usually include any produced physical good needed to provide or keep records of the needed information, such as machinery, computers, and other equipment. For this ICR, EPA estimates that there are no respondent capital costs.

TABLE 3: REPORTING AND RECORDKEEPING REQUIREMENTS FOR HANDLERS, COLLECTORS AND PROCESSORS: ANNUAL RESPONDENT BURDEN AND COST SUMMARY (ALL RESPONDENTS)

Respondent Type Total Hours for Annual Variable Costs Labor Costs Capital Costs O& M Costs Total Costs Small quantity handlers/ collectors 14,812 $119,617 $0 $0 $119,617 Large quantity handlers/ collectors 1,011 $57,476 $0 $0 $57,476 Processors 33 $152 $0 $0 $152 TOTAL 15,855 $177,245 $0 $0 $177,245 Page 15 6( d) Reasons for Change in Burden EPA expects that the proposed rule will result in a reduction in burden to the regulated waste CRT community. CRT entities sending broken CRTs or CRT glass for recycling would no longer be subject to full Subtitle C requirements. Following is a list of primary RCRA reporting and recordkeeping requirements that CRT entities may be relieved of:

 Reporting waste generation data for the EPA's Biennial Report, as covered in ICR No. 976, Biennial Report ICR;

 EPA notification of hazardous waste activity;

 Reporting and recordkeeping under the land disposal restrictions (LDRs) program of 40 CFR Part 268, as covered in ICR No. 1442, Land Disposal Restrictions ICR;

 Reporting and recordkeeping under the hazardous waste manifest requirements, as covered in ICR No. 801, Manifest ICR; and  Recordkeeping and/ or reporting of personnel training, contingency plan, and emergency procedures under the generator standards of 40 CFR Part 262, as covered in ICR No. 820, Hazardous Waste Generator Standards ICR.

Table 4 presents the average and the total avoided respondent burden resulting from the proposed rule. This avoided burden is based on the average annual burden per respondent as estimated in the ICRs listed above. Table 4 also presents the total estimated avoided entity burden by multiplying the average avoided burden per respondent by the total number of CRT entities expected to be affected by the proposed rule. Page 16 Table 4 Average and Total Annual Avoided Respondent Burden (Hours) Primary RCRA Requirements No Longer Applicable to CRT Glass toglass Regulated Entities Average Annual Respondent Burden Savings per Regulated Entity (in hours) Small Quantity Handler Large Quantity Handler Processor Prepare and Submit Notification of Hazardous Waste Activity 1 (RP)

1. 5 (RP)

N/ A Prepare and submit Hazardous Waste Biennial Report Forms N/ A 12 (RP)

12 (RP) Prepare and transmit LDR notifications to treatment and disposal facilities and keep records 1 (RP)

2(

RP)

6 (RP) 0.5 (RK)

1(

RK)

2 (RK) Prepare and transmit manifests and keep records 1 (RP)

2(

RP)

8 (RP) 0.5 (RK)

1(

RK)

2 (RK) Personnel training 0.5 (RK)

4 (RK)

8 (RK) Contingency plan N/ A 3 (RK)

6 (RK) Emergency procedures 0 2 (RK)

2 (RK) Total Avoided Burden per Regulated Entity 3 (RP)

17.5 (RP)

26 (RP) 1.5 (RK)

11 (RK)

20 (RK) Number of Regulated Entities Affected by the Proposed Rule 2116 311 5 Total Avoided Burden 6,348 (RP)

5,443 (RP)

130 (RP) 3,174 (RK)

3,421 (RK)

100 (RK) RP:

Reporting;

RK:

Recordkeeping Page 17 6( e) Burden Statement Table 5 presents the estimated average burden hours per respondent per year for the reporting and recordkeeping requirements covered by this ICR. The reporting burden includes time to comply with the proposed notification, environmental justice, and exporting requirements. The recordkeeping burden includes time to follow the proposed labeling/ marking and storage time limit requirements.

Table 5 Average Annual Burden per CRT Respondent (Hours)

Type of Regulated Entity Estimated Annual Reporting Burden Estimated Annual Recordkeeping Burden Estimated Number of Each Entity Estimated Total Burden Small Quantity Generators/ Collectors 0 1 2,116 2,116 Large Quantity Generators/ Collectors 0 3. 25 311 1011 Processors 0 0. 5 5 2. 5 As shown in Table 5, the total annual burden is estimated to be 1 hour for small quantity handlers, 3.25 hours for large quantity handlers, and 0.5 hour for processors.

An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB numbers for EPA's regulation are listed in 40 CFR Part 9 and 48 CFR Chapter 15.

Send comments regarding these burden statements or any other aspect of this collection, including suggestions for reducing the burden, including through the use of automated collection techniques, to the Director, Office of Policy, U. S. Environmental Protection Agency (2822), 1200 Pennsylvania Ave., N. W., Washington, D. C. 20460 and to the Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for EPA, 725 17th Street, N. W., Washington, D. C. 20503. Include the OMB control number in any correspondence.


(D)(i)(II).
Section 110(a)(2)                Statewide........  7/10/2014........  10/13/2015, 80 FR  Approved CAA elements:
 Infrastructure Requirements                                            61311.             110(a)(2)(A), (B),
 for the 2010 nitrogen dioxide                                                             (C), (D), (E), (F),
 (NO2) NAAQS.                                                                              (G), (H), (J), (K),
                                                                                (L), and (M). We are
                                                                                not taking action on
                                                                                the visibility
                                                                                portion of
                                                                                (D)(i)(II).
Section 110(a)(2)                Statewide........  7/10/2014........  10/13/2015, 80 FR  Approved CAA elements:
 Infrastructure Requirements                                            61311.             110(a)(2)(A), (B),
 for the 2008 sulfur dioxide                                                               (C), (D), (E), (F),
 (SO2) NAAQS.                                                                              (G), (H), (J), (K),
                                                                                (L), and (M). We are
                                                                                not taking action on
                                                                                (D)(i)(I) and the
                                                                                visibility portion of
                                                                                (D)(i)(II).

Section 110(a)(2)                Statewide........  7/10/2014........  10/13/2015, 80 FR  Approved CAA elements:
 Infrastructure Requirements                                            61311.             110(a)(2)(A), (B),
 for the 2012 particulate                                                                  (C), (D), (E), (F),
 matter (PM2.5) NAAQS.                                                                     (G), (H), (J), (K),
                                                                                (L), and (M). We are
                                                                                not taking action on
                                                                                (D)(i)(I) and the
                                                                                visibility portion of
                                                                                (D)(i)(II).
----------------------------------------------------------------------------------------------------------------
                                                Maintenance Plans
----------------------------------------------------------------------------------------------------------------
Carbon monoxide................  Detroit area       3/18/1999........  6/30/1999, 64 FR   ......................
                                  (portions of                          35017.
                                  Wayne, Oakland,
                                  and Macomb
                                  Counties).
Carbon monoxide................  Detroit area       12/19/2003.......  1/28/2005, 64 FR   Revision to motor
                                  (portions of                          35017.             vehicle emission
                                  Wayne, Oakland,                                          budgets.
                                  and Macomb
                                  Counties).
1-hour ozone...................  Detroit-Ann Arbor  11/12/1994.......  3/7/1995, 60 FR
                                  area                                  12459.
                                  (Livingston,
                                  Macomb, Monroe,
                                  Oakland, St.
                                  Clair,
                                  Washtenaw, and
                                  Wayne Counties).
1-hour ozone...................  Grand Rapids area  3/9/1995.........  6/21/1996, 61 FR
                                                                        31831.
1-hour ozone...................  Muskegon County..  3/9/1995.........  8/30/2000, 65 FR
                                                                        52651.
1-hour ozone...................  Allegan County...  9/1/2000 and 10/   11/24/2000, 65 FR
                                                     13/2000.           70490.
1-hour ozone...................  Flint (Genesee     5/9/2000.........  11/13/2000, 65 FR
                                  County) and                           67629.
                                  Saginaw-Midland-
                                  Bay City (Bay,
                                  Midland, and
                                  Saginaw
                                  Counties).
1-hour ozone...................  Muskegon County..  3/22/2001........  8/6/2001, 66 FR    Revision to motor
                                                                        40895.             vehicle emission
                                                                                budgets.
1-hour ozone update............  Detroit-Ann Arbor  12/19/2003.......  5/20/2005, 70 FR
                                  area                                  29202.
                                  (Livingston,
                                  Macomb, Monroe,
                                  Oakland, St.
                                  Clair,
                                  Washtenaw, and
                                  Wayne Counties).
1997 8-hour ozone..............  Grand Rapids       5/9/2006, 5/26/    5/16/2007, 72 FR
                                  (Kent and Ottawa   2006, and 8/25/    27425.
                                  Counties),         2006.
                                  Kalamazoo-Battle
                                  Creek (Calhoun,
                                  Kalamazoo, and
                                  Van Buren
                                  Counties),
                                  Lansing-East
                                  Lansing
                                  (Clinton, Eaton,
                                  and Ingham
                                  Counties),
                                  Benzie County,
                                  Huron County,
                                  and Mason County.

1997 8-hour ozone..............  Flint (Genesee     6/13/2006, 8/25/   5/16/2007, 72 FR
                                  and Lapeer         2006, and 11/30/   27425.
                                  Counties),         2006.
                                  Muskegon
                                  (Muskegon
                                  County), Benton
                                  Harbor (Berrien
                                  County), and
                                  Cass County.
1997 8-hour ozone..............  Detroit-Ann Arbor  3/6/2009.........  6/29/2009, 74 FR
                                  (Lenawee,                             30950.
                                  Livingston,
                                  Macomb, Monroe,
                                  Oakland, St.
                                  Clair,
                                  Washtenaw, and
                                  Wayne Counties).
Particulate matter.............  Macomb, Oakland,   6/27/1974 and 10/  6/2/1975, 40 FR
                                  Wayne and Monroe   18/1974.           23746.
                                  Counties.
PM-10..........................  Wayne County.....  7/24/1995........  8/5/1996, 61 FR
                                                                        40516.
1997 Annual PM2.5..............  Detroit-Ann Arbor  7/05/2011........  8/29/2013, 78 FR
                                  area                                  53274.
                                  (Livingston,
                                  Macomb, Monroe,
                                  Oakland, St.
                                  Clair,
                                  Washtenaw, and
                                  Wayne Counties).
2006 24-Hour PM2.5.............  Detroit-Ann Arbor  7/05/2011........  8/29/2013, 78 FR
                                  area                                  53274.
                                  (Livingston,
                                  Macomb, Monroe,
                                  Oakland, St.
                                  Clair,
                                  Washtenaw, and
                                  Wayne Counties).
----------------------------------------------------------------------------------------------------------------
                                              Negative Declarations
----------------------------------------------------------------------------------------------------------------
Negative declarations..........  Wayne, Oakland     10/10/1983, 5/17/  11/24/1986, 51 FR  Includes large
                                  and Macomb         1985, and 6/12/    42221.             petroleum dry
                                  Counties.          1985.                                 cleaners, high-
                                                                                density polyethylene,
                                                                                polypropylene, and
                                                                                polystyrene resin
                                                                                manufacturers, and
                                                                                synthetic organic
                                                                                chemical
                                                                                manufacturing
                                                                                industry--oxidation.
Negative declarations..........  Detroit-Ann Arbor  3/30/1994........  9/7/1994, 59 FR    Includes: Large
                                  Area                                  46182.             petroleum dry
                                  (Livingston,                                             cleaners, SOCMI air
                                  Macomb, Monroe,                                          oxidation processes,
                                  Oakland, St.                                             high-density
                                  Clair, Washtenaw                                         polyethylene and
                                  and Wayne                                                polypropylene resin
                                  Counties) Grand                                          manufacturing and
                                  Rapids Area                                              pneumatic rubber tire
                                  (Kent and Ottawa                                         manufacturing.
                                  Counties), and
                                  Muskegon County.
----------------------------------------------------------------------------------------------------------------

                                          Section 182(f) NOX Exemptions
----------------------------------------------------------------------------------------------------------------
1-hour ozone...................  Detroit-Ann Arbor  11/12/1993.......  8/10/1994, 59 FR
                                  area                                  40826.
                                  (Livingston,
                                  Macomb, Monroe,
                                  Oakland, St.
                                  Clair,
                                  Washtenaw, and
                                  Wayne Counties).
1-hour ozone...................  Clinton, Ingham,   7/1/1994 and 7/8/  4/27/1995, 60 FR
                                  Eaton, and         1994.              20644.
                                  Genesee Counties.
1-hour ozone...................  Kent, Ottawa,      7/13/1994........  1/26/1996, 61 FR
                                  Muskegon,                             2428.
                                  Allegan, Barry,
                                  Bay, Berrien,
                                  Branch, Calhoun,
                                  Cass, Clinton,
                                  Eaton, Gratiot,
                                  Genesee,
                                  Hillsdale,
                                  Ingham, Ionia,
                                  Jackson,
                                  Kalamazoo,
                                  Lenawee,
                                  Midland,
                                  Montcalm, St.
                                  Joseph, Saginaw,
                                  Shiawassee, and
                                  Van Buren
                                  Counties.
1-hour ozone...................  Muskegon County..  11/22/1995.......  9/26/1997, 62 FR
                                                                        50512.
1997 8-hour ozone..............  Grand Rapids       1/17/2015........  6/6/2006, 71 FR
                                  (Kent and Ottawa                      32448.
                                  Counties),
                                  Kalamazoo-Battle
                                  Creek (Calhoun,
                                  Kalamazoo, and
                                  Van Buren
                                  Counties),
                                  Lansing-East
                                  Lansing
                                  (Clinton, Eaton,
                                  and Ingham
                                  Counties),
                                  Benzie County,
                                  Huron County and
                                  Mason County.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-15141 Filed 6-27-16; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 166 (Monday, August 27, 2018)]
[Proposed Rules]
[Pages 43561-43563]
[FR Doc No: 2018-18472]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0737; Product Identifier 2017-SW-096-AD]
RIN 2120-AA64

Airworthiness Directives; Leonardo S.p.A. Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
Leonardo S.p.A. (Type Certificate Previously Held by Finmeccanica
S.p.A., AgustaWestland S.p.A.) Model AW139 helicopters. This proposed
AD would require inspecting and altering the number 1 driveshaft
(driveshaft). This proposed AD is prompted by reports of scratches that
were found on the driveshaft. The actions of this proposed AD are
intended to prevent an unsafe condition on these products.

DATES: We must receive comments on this proposed AD by October 26,
2018.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0737; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this proposed AD, the European Aviation Safety Agency (EASA) AD, the
economic evaluation, any comments received, and other information. The
street address for Docket Operations (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.
    For service information identified in this proposed rule, contact
Leonardo S.p.A. Helicopters, Matteo Ragazzi, Head of Airworthiness,
Viale G. Agusta 520, 21017 C. Costa di Samarate (Va) Italy; telephone
+39-0331-711756; fax +39-0331-229046; or at http://www.leonardocompany.com/-/bulletins. You may review the referenced
service information at the FAA, Office of the Regional Counsel,
Southwest Region, 10101 Hillwood Pkwy, Room 6N-321, Fort Worth, TX
76177.

FOR FURTHER INFORMATION CONTACT: David Hatfield, Aviation Safety
Engineer, Safety Management Section, Rotorcraft Standards Branch, FAA,
10101 Hillwood Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>;
email [email protected].

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to participate in this rulemaking by submitting
written comments, data, or views. We also invite comments relating to
the economic, environmental, energy, or federalism impacts that might
result from adopting the proposals in this document. The most helpful
comments reference a specific portion of the proposal, explain the
reason for any recommended change, and include supporting data. To
ensure the docket does not contain duplicate comments, commenters
should send only one copy of written comments, or if comments are filed
electronically, commenters should submit only one time.
    We will file in the docket all comments that we receive, as well as
a report summarizing each substantive public contact with FAA personnel
concerning this proposed rulemaking. Before acting on this proposal, we
will consider all comments we receive on or before the closing date for
comments. We will consider comments filed after the comment period has
closed if it is possible to do so without incurring expense or delay.
We may change this proposal in light of the comments we receive.

Discussion

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD No. 2017-0011, dated January 25,
2017, to correct an unsafe condition for certain serial-numbered
Leonardo S.p.A. (formerly Finmeccanica S.p.A, AgustaWestland S.p.A.)
Model AW139 helicopters. EASA advises of several helicopters found with
scratches on the driveshaft part-number (P/N) 3G6510A01132 and that an
investigation determined only helicopters equipped with rear exhaust
module assembly P/N 3G7810A00431 and tunnel assembly P/N 3G7130A13431
are affected. According to EASA, the scratches resulted from
insufficient clearance between the driveshaft and the rear exhaust
module and tunnel assemblies. EASA further advises that if not
corrected, these scratches could lead to a crack in the driveshaft,
failure of the tail rotor drive system, and subsequent reduced control
of the helicopter. To prevent this potential unsafe condition, the EASA
AD requires repetitive inspections of the driveshaft for a crack until
the exhaust module and tunnel assembly are modified to increase the
clearance.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Italy and are approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, its technical representative,
has notified us of the unsafe condition described in its AD. We are
proposing this AD because we evaluated all known relevant information
and determined that an unsafe condition is likely to exist or develop
on other products of the same type design.

Related Service Information Under 1 CFR Part 51

    We reviewed Leonardo Helicopters Bollettino Tecnico No. 139-465,
Revision A, dated January 25, 2017, which contains procedures for
visual and eddy-current inspections of the driveshaft. This service
information also contains procedures for modifying the exhaust module
and tunnel assemblies.
    This service information is reasonably available because the
interested parties have access to it through their normal course of
business or by the means identified in the ADDRESSES section.

Proposed AD Requirements

    This proposed AD would require, within 30 hours time-in-service
(TIS) and thereafter at intervals not exceeding 100 hours TIS,
inspecting the driveshaft tube P/N 3G6510A00832 for a scratch and
indentation. If there is a scratch or indentation, the proposed AD
would require, before further flight, repairing the driveshaft tube and
performing a depth check of the repaired area. If the repaired area
depth is more than 0.2 mm, the proposed AD would require replacing the
driveshaft tube and altering the rear exhaust module and tunnel
assembly before further flight. If the depth of the repaired area of
the tube is 0.2 mm or less, the proposed AD would require, before
further flight, performing an eddy current inspection of the tube for a
crack. If there is a crack,

the proposed AD would require replacing the driveshaft tube and
altering the rear exhaust module and tunnel assembly before further
flight.
    This proposed AD would also require, within 300 hours TIS, altering
the rear exhaust module and tunnel assembly, if not previously done as
a result of the inspections. Because this proposed AD would also
require re-identifying the tunnel assembly part number after it is
altered, this would be terminating action for the repetitive
inspections.

Costs of Compliance

    We estimate that this proposed AD would affect 55 helicopters of
U.S. Registry.
    We estimate that operators may incur the following costs in order
to comply with this AD, based on an average labor rate of $85 per work-
hour. Inspecting, repairing, and eddy-current inspecting the driveshaft
tube would require about 6 work-hours, and required parts cost would be
minimal, for a cost of $510 per helicopter and $28,050 for the U.S.
fleet per inspection cycle. Altering the rear exhaust module and tunnel
assembly would require about 20 work-hours, and required parts would
cost $1,500, for a cost of $3,200 per helicopter and $176,000 for the
U.S. fleet.
    If required, replacing a driveshaft tube would require 1 work-hour,
and required parts would cost $6,500, for a cost per helicopter of
$6,585.
    According to Leonardo Helicopter's service information some of the
costs of this proposed AD may be covered under warranty, thereby
reducing the cost impact on affected individuals. We do not control
warranty coverage by Leonardo Helicopters. Accordingly, we have
included all costs in our cost estimate.

Authority for This Rulemaking

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

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed, I certify this proposed regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

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

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13   [Amended]

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

Leonardo S.p.A. (Type Certificate Previously Held by Finmeccanica
S.p.A, AgustaWestland S.p.A.): Docket No. FAA-2018-0737; Product
Identifier 2017-SW-096-AD.

(a) Applicability

    This AD applies to Model AW139 helicopters, serial numbers
31499, 31504, 31507, 31509, 31512, 31518, 31519, 31524, 31529,
31533, 31535 through 31564, 31567, 31569, 31570, 31589, 41363, 41368
through 41370, 41372 through 41375, 41378, 41381, and 41384, with a
tunnel assembly part number 3G7130A13431 installed, certificated in
any category.

 (b) Unsafe Condition

    This AD defines the unsafe condition as a crack in a tail rotor
driveshaft, which could result in failure of the tail rotor drive
system and subsequent loss of control of the helicopter.

 (c) Comments Due Date

    We must receive comments by October 26, 2018.

 (d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

 (e) Required Actions

    (1) Within 30 hours time-in-service (TIS) and thereafter at
intervals not to exceed 100 hours TIS, inspect the number 1
driveshaft tube shaft, P/N 3G6510A00832, for a scratch and
indentation in the area depicted in Figure 1 of Leonardo Helicopters
Bollettino Tecnico No. 139-465, Revision A, dated January 25, 2017
(BT 139-465). If there is a scratch or indentation, before further
flight:
    (i) Repair the tube shaft in accordance with the Compliance
Instructions, Part I, paragraphs 7.1 through 7.3, of BT 139-465.
    (ii) Measure the depth of the repaired areas as depicted in
Figure 2 of BT 139-465.
    (A) If the depth of the reworked area is 0.2 mm (0.079 inch) or
less, eddy-current inspect the driveshaft for a crack as described
in the Compliance Instructions, Annex A, of BT 139-465. If there is
a crack, before further flight, replace the driveshaft, alter the
rear exhaust module, and alter and re-identify the tunnel assembly
in accordance with the Compliance Instructions, Part II, paragraphs
7 through 12, of BT 139-465.
    (B) If the depth of the reworked area is more than 0.2 mm (0.079
inch), before further flight, replace the driveshaft, alter the rear
exhaust module, and alter and re-identify the tunnel assembly in
accordance with the Compliance Instructions, Part II, paragraphs 7
through 12, of BT 139-465.
    (2) Within 300 hours TIS, unless already accomplished as
required by paragraph (e)(1)(ii) of this AD, alter the rear exhaust
module and alter and re-identify the tunnel assembly in accordance
with the Compliance Instructions, Part II, paragraphs 7 through 12,
of BT 139-465.

 (f) Special Flight Permits

    Special flight permits are prohibited.

 (g) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Section, Rotorcraft Standards
Branch, FAA, may approve AMOCs for this AD. Send your proposal to:
David Hatfield, Aviation Safety Engineer, Safety Management Section,
Rotorcraft Standards Branch, FAA, 10101 Hillwood Pkwy., Fort Worth,
TX 76177; telephone<PHONE_NUMBER>; email [email protected].
    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that

you notify your principal inspector, or lacking a principal
inspector, the manager of the local flight standards district office
or certificate holding district office before operating any aircraft
complying with this AD through an AMOC.

 (h) Additional Information

    The subject of this AD is addressed in European Aviation Safety
Agency (EASA) AD No. 2017-0011, dated January 25, 2017. You may view
the EASA AD on the internet at http://www.regulations.gov in the AD
Docket.

 (i) Subject

    Joint Aircraft Service Component (JASC) Code: 6510 Tail Rotor
Driveshaft.

    Issued in Fort Worth, Texas, on August 10, 2018.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2018-18472 Filed 8-24-18; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 185 (Tuesday, September 28, 2021)]
[Notices]
[Pages 53663-53664]
[FR Doc No: 2021-21000]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0689]

Public Workshop: Analgesic Clinical Trial Designs, Extrapolation,
and Endpoints in Patients From Birth to Less Than Two Years of Age

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing a public
workshop entitled ``Analgesic Clinical Trial Designs, Extrapolation,
and Endpoints in Patients from Birth to Less Than Two Years of Age.''
The purpose of the public workshop is to discuss the state of science,
data gaps, and challenges in drug development for drugs intended to
treat acute pain in patients less than 2 years of age.

DATES: The public workshop will be held virtually on October 13 and 14,
2021, from 10 a.m. to 2 p.m. Eastern Standard Time. See the
SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: The public workshop will be held in virtual format only and
will not be held at a specific location. Please note that due to the
impact of the COVID-19 pandemic, all meeting participants will be
joining this public meeting via an online teleconferencing platform.
The public workshop will be held at https://go.umd.edu/analgesic-clinical-trial.

FOR FURTHER INFORMATION CONTACT: Heather Buck at
<EMAIL_ADDRESS>301-796-1413 or Kerri-Ann Jennings at eda6889f9f84c0ac8383c3a788838384838a9ead8b898cc385859ec38a829b,<PHONE_NUMBER>, Food and Drug Administration,
Center for Drug Evaluation and Research, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 6467, Silver Spring, MD 20903-0002.

SUPPLEMENTARY INFORMATION:

I. Background

    In 2009, FDA convened a scientific workshop with experts in
pediatric pain, pediatric clinical trial design, pediatric ethics, and
pediatric drug development \1\. Based on the available data at the
time, the expert panel recommended extrapolation of efficacy in
patients 2 years and older, relying on matching effective drug
exposures in adults. The current approach to study drugs with well-
established mechanisms of action, such as opioids, non-steroidal anti-
inflammatory drugs (NSAIDS), acetaminophen, and local anesthetics,
relies on matching safe and effective drug exposures in adults to
support the efficacy of drugs used to treat acute pain in pediatric
patients at least 2 years of age. Controlled efficacy trials are only
required in patients from birth to less than 2 years of age. When
controlled efficacy trials are needed, FDA has recommended an ``add-
on'' design using opioid-sparing calculation rather than the change in
pain intensity used in efficacy trials of analgesics in adults.
---------------------------------------------------------------------------

    \1\ Berde, CB, et.al., Pediatrics 2012 Feb;129(2):354-64.
https://www.fda.gov/advisory-committees/advisory-committee-calendar/april-12-2016-pediatric-advisory-committee-meeting-announcement-04122016-04122016.
---------------------------------------------------------------------------

    Despite these advances in clinical trial design, there continues to
be unmet needs in the availability of products to treat acute pain,
especially in patients less than 2 years of age. There is currently
only one analgesic labeled for use in patients less than 2 years of
age: Ibuprofen is approved for the treatment

of pain in children 6 months of age and older. Furthermore, controlled
trials in patients less than 2 years of age have been difficult to
complete and the data obtained from completed trials have often been
difficult to interpret.
    The purpose of the public workshop is to discuss the current state
of therapies to treat acute pain in children, identify data gaps, and
consider methods to improve the current drug development paradigm for
acute pain in patients less than 2 years of age (e.g., use of pediatric
extrapolation, and novel clinical trial designs). The workshop is
intended to focus on drugs with well-established mechanisms of action
(NSAIDs, acetaminophen, local anesthetics, opioids), rather than drugs
with novel mechanisms of action.

II. Topics for Discussion at the Public Workshop

    The main objective of the ``Analgesic Clinical Trial Designs,
Extrapolation, and Endpoints in Patients from Birth to Less Than Two
Years of Age'' workshop is to discuss the current state of therapies to
treat acute pain in children, identify data gaps, and discuss feasible
trial designs and methods (e.g., use of pediatric extrapolation) to
improve the current drug development paradigm for acute pain in
patients less than 2 years of age. The workshop will include
regulators, industry, academia, and patient organizations to optimize
the discussion of the selected topics.

III. Participating in the Public Workshop

    Registration: Please visit the following website to register for
this public workshop: https://go.umd.edu/analgesic-clinical-trial.
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone.
    Streaming Webcast of the Public Workshop: This public workshop will
also be webcast at the following site: https://collaboration.fda.gov/rz3mubd491lo/.
    If you have never attended a Connect Pro event before, test your
connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. For an overview of the Connect Pro program, visit
https://www.adobe.com/go/connectpro_overview. FDA has verified the
website addresses in this document, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

    Dated: September 22, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-21000 Filed 9-27-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 230 (Friday, November 29, 2013)]
[Notices]
[Page 71709]
[FR Doc No: 2013-28688]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2013-0114]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    In accordance with part 235 of Title 49 Code of Federal Regulations
and 49 U.S.C. 20502(a), this document provides the public notice that
by a document dated September 26, 2013, Norfolk Southern Corporation
(NS) and Bay Coast Railroad (BCR) jointly petitioned the Federal
Railroad Administration (FRA) seeking approval for the discontinuance
or modification of a signal system. FRA assigned the petition Docket
Number FRA-2013-0114.
    Applicant: Norfolk Southern Corporation, Mr. Brian L. Sykes, Chief
Engineer C&S Engineering, 1200 Peachtree Street NE., Atlanta, GA 30309.

Bay Coast Railroad, Mr. Larry Lemond, Vice President Operations, 202
Mason Avenue, Cape Charles, VA 23310.

    NS and BCR seek approval of the proposed modification of the
Coleman Place Interlocking, Milepost (MP) A1.4, Sewells Point Branch,
Virginia Division, Norfolk, VA. The Coleman Place Interlocking will be
redesigned and renewed with electronic control equipment and new
signals arranged to the existing track configuration. Due to previous
removal of the diamond crossing at the interlocking, the westbound home
signal and the start of traffic control territory will move west
approximately 1,000 feet. The existing No. 2 power-crossover switch
will be converted to hand operation.
    The reason given for the proposed changes is that the need for the
power-crossover switch no longer exists with the removal of the diamond
crossing.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.
    Communications received by January 13, 2014 will be considered by
FRA before final action is taken. Comments received after that date
will be considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
See http://www.regulations.gov/#!privacyNotice for the privacy notice
of regulations.gov or interested parties may review DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477).

Robert C. Lauby,
Associate Administrator for Railroad Safety, Chief Safety Officer.
[FR Doc. 2013-28688 Filed 11-27-13; 8:45 am]
BILLING CODE 4910-06-P