1 These meeting notes are summary in nature and should be read in conjunction with the meeting materials included on the EPA website.

2 Throughout this meeting, speakers used various terms to refer to the solid materials generated as a result of the combustion of coal, including: coal combustion waste, coal combustion byproducts, coal combustion products, and coal ash. For ease of presentation, these notes use the abbreviation " CCW" throughout, except in cases where the speaker was making a point regarding distinctions between the terms used. The use of " CCW" in these notes is not meant to imply a preference for the categorization of these materials as " waste." Joint IMCC EPA Summary Meeting Notes1 from the State/ Tribal/ Federal Meeting on Mine Placement of Coal Combustion Waste Williamsburg, Virginia October 29 and 30, 2002 Opening Remarks ( Greg Conrad, Executive Director, IMCC)

Greg Conrad welcomed attendees and provided some background on the purpose of the meeting. A great deal of information has been shared over the last two years and the group is moving closer to points of understanding. In addition, EPA and OSM are nearing the point where key decisions will have to be made regarding potential federal regulations for mine placement of coal combustion wastes ( CCW). 2 In the near future, EPA may be briefing its upper management on the decision. The following particular issues have been identified by the group:

° Should there be a distinction between beneficial use and disposal? ° Do gaps exist in current regulations, given consideration of SMCRA, RCRA, coal mine programs, and non coal mine programs? ° How should a decision address the relationships between programs within each State ( e. g., mining and solid waste programs, coal and non coal mining programs)? ° How should a decision address the relationship between the two federal programs ( SMCRA and RCRA)? ° Prior to any decision making, we need to sit down with representatives of the environmental community, relay the data and findings, and listen to their perspective.

The States held a meeting in Reston, Virginia this summer that focused on these remaining key issues. EPA should leave this meeting with fairly clear picture of where this group stands on these issues. IMCC and the States would like to continue the momentum gained in previous meetings. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 2 Part I: Update on EPA's State Minesite Visits ( Bonnie Robinson, EPA Office of Solid Waste)

EPA has completed its program of visits to the following States: Oklahoma, Illinois, Indiana, Pennsylvania, Ohio, West Virginia, Maryland, North Dakota, New York, and the Navajo Nation. The Agency hopes to have the reports from all of the visits completed and posted on the website by the end of this year. EPA appreciates the time and effort contributed by the State participants in setting up and conducting these visits. The Agency has gained valuable information as a result of the visits.

According to IMCC, the States are looking forward to seeing the results of the visits to their sister States. States that hosted visits since the last meeting provided the following feedback on their experiences:

° West Virginia hosted EPA's visit during the first part of this month. The EPA discussion guide was useful in getting all the nuances of the West Virginia mine placement program on paper. It seemed that EPA gained valuable experience as a result of the discussions and the site visits.

° Oklahoma hosted EPA's visit at the end of July. The visit was very productive. On the first day, EPA and the State reviewed permits and the State's program guidelines. On the second day, they toured several placement sites, including active and inactive sites and a site in the reclamation phase. This provided different perspectives on different sites.

° The visit to Maryland included representation not only from the State's mining program, but also from the State's solid waste and NPDES programs. The EPA discussion guide was helpful for the State to gain a broad perspective on the program elements of interest to EPA. The participants visited a hard rock mining site on the first day. On the second day, the group visited a project involving underground injection of flue gas desulfurization ( FGD) material at a coal mine and a cogen power facility.

° The New York visit included representation from the State's solid waste program and the division of mineral resources. The participants visited the only minefill site in the State, which is a 70 acre dolomite quarry near Rochester. The State believes that EPA was satisfied with the project and the procedures in place to monitor its performance.

IMCC believes it is key to marry the results from these visits with EPA's continuing regulatory concerns and hopes the insights gained inform EPA's final decision. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 3 Part II: Update on EPA's State Regulatory Program Analysis Reports ( Greg Conrad, Executive Director, IMCC)

EPA, through IMCC, has provided the latest drafts ( dated August 2002) of the following two reports:

° Regulation and Policy Concerning Mine Placement of Coal Combustion Waste in Selected States ° Mine Placement of Coal Combustion Waste   State Program Elements Analysis EPA is still incorporating information from some of the last few State visits, but the reports are essentially final. States should make sure these reports are accurate. Any remaining comments should be submitted to EPA within 30 days before the reports become part of EPA's administrative record. Contact Bonnie Robinson ( phone: 703 308 8429; email: robinson. bonnie@ epa. gov) to submit comments.

Part III: Update on MRAM Project ( Andy Wittner, EPA Office of Solid Waste)

EPA is in the process of an empirical evaluation of monitoring data from mine placement sites. The Agency appreciates the monitoring data provided by the States participating in this meeting. To date, EPA has conducted preliminary evaluations of eight sites   four in Indiana and four in Pennsylvania. This presentation will show a great deal of detail regarding these eight sites, but EPA has not yet drawn conclusions from the analysis. EPA is not prepared to draw conclusions because the analysis to date covers only a small sample with limited geographic/ geochemical representativeness, and the analysis is not even complete for this small sample. Therefore, EPA is presenting its preliminary analysis here, but not offering conclusions based on the analysis.

EPA estimates there are roughly 150 coal mines, plus more non coal mines, receiving CCW. There are potentially 600 additional coal mines, and maybe 1,000' s of non coal mines, that could use CCW. Therefore, if placement is done protectively, there is a great deal of upside potential for this beneficial use. As a note, unlike mine placement, other beneficial uses of CCW have a host of competitive products. This may explain the general lack of uptrends in these uses.

EPA chose the sites evaluated so far from among some 65 reports from sources including academic institutions, State agencies, OSM, etc. EPA believes the data set is as unbiased as possible because of the variety of sources. EPA encountered certain complexities in analyzing the eight sites, including changes in well placement as mine placement progressed and changes in the water table. EPA also notes that it does not necessarily have all the data available for each site.

EPA presented its preliminary evaluation of the monitoring data for the eight sites. Copies of the presentation slides are included among the meeting materials. EPA discussed in detail the Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 4 evaluation of three Pennsylvania sites ( Big Gorilla, B D Mine, and Revloc Refuse Site) with the following overall comments:

° None of the results so far show anything that looks conclusively like an environmental problem at these sites. ° It is tempting to draw a null conclusion based on this, but EPA does not yet have a large enough sample of sites. ° Therefore, it seems advisable to continue the analysis.

The preliminary evaluation of the other five sites does not show anything dramatically different from the evaluation of the first three, so EPA did not discuss the remaining sites in detail.

Meeting participants had the following questions and comments on this presentation:

° Pennsylvania commented that the Big Gorilla evaluation compares an upgradient well to the surface overflow. The State believes CCW has blocked the flow from the pit to the underground mine complex to the surface outfall. A more accurate analysis would look at contaminant loading rates.

° Question: How are the results of the MRAM analysis going to be factored into any regulatory decision? The previous understanding was that EPA's regulatory determination is on a separate track and that the MRAM analysis would take longer. Is completion of the evaluation necessary for an effective administrative record for the regulatory determination? ° Answer: the evaluation should be complete by January 2004 in time for the regulatory determination. The results of the evaluation may be an important factor in the determination, as the issue of whether or not existing practices are protective is critical. It is uncertain, though, what EPA's senior management will view as most critical.

° Question: Is EPA evaluating CCW placement in comparison to the alternatives, such as other fill materials or doing nothing at all? ° Answer: No. The analysis is of the impacts of CCW placement alone, without comparison to alternatives.

° IMCC commented that it appears EPA could use more data to conduct this analysis. If States have concerns about how the evaluation relates to the overall effort or the methodology used to conduct the analysis, they should be sure to articulate those to EPA. ( Note: additional discussion of State concerns relating to the MRAM project occurred later in the meeting. See Section VIII, below.) Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 5 Part IV: Presentation on Beneficial Use of Dredged Material with CCW ( Andrew Voros, NJ/ NY Clean Oceans and Shore Trust)

The NJ/ NY Clean Oceans and Shore Trust ( COAST) represents a bi State Legislative committee. Its purpose is to address any environmental or economic issue between the two States   including the major issue, disposal of dredged material from New York Harbor. For eight years, NJ/ NY COAST has devoted all of its resources to disposal of dredged materials. New York Harbor generates approximately 4 million tons of dredged materials per year. Due to increases in shipping and in the size of container ships ( the largest of which currently cannot enter New York harbor), there are plans to deepen to 50 feet. This process will cost approximately $ 2.3 billion and generate approximately 150 million tons of material containing trace contaminants.

Due to the sensitivity about interstate movement of waste, NJ/ NY COAST started consulting with the Pennsylvania Department of Environmental Protection seven years ago about whether dredged material would be appropriate for abandoned mine reclamation. Ultimately, after one and a half to two years, they decided to do a demonstration project using dredged materials amended with fly ash to remediate a high wall. The goal was to create a monolithic mass of cementitious material with low permeability that expands as it cures. The site selected for the demonstration is not optimal in terms of geographic location ( in western Pennsylvania, distant from New York Harbor). The site was selected, however, because of its long history of baseline environmental testing.

The project is a $ 20 million demonstration. There is a port side processing facility at which the dredged material is sized and amended with pozzolanic material ( fly ash from New York State). The dredged material is 65% water, but 15% amendment with fly ash makes it stand up. The amended material is transported via train to a processing facility at the site. The material is then trucked onto the site, spread, and compacted in lifts to establish original contour.

The site is one with exposed acid generating material. It has been filled using 0.5 million tons of the processed dredged material and 0.5 million tons of amendment ( CCW, cement kiln dust, other lime materials). The fill is topped with artificial topsoil material. Part of lift was left unfilled as control site. The project includes extensive monitoring of the dredged material  inplace in the harbor, arriving by rail, and the final pugmill blend. The local community has been involved in every step of the process. Their greatest concern was the potential for using the project as a " cover" for disposing of something else. There is extensive historical monitoring data and ongoing surface water monitoring and ground water monitoring ( including 6 downgradient wells and 12 domestic wells). There have been over 18,000 individual tests, with about 4 detects in the waste itself. No contaminants have been detected in the water monitoring. They also have conducted an extensive geophysical underground profile of the material in place, finding no cracks or fissures, no water moving underneath, and no anomalies. The reclamation permit for this project was written so that the bond covers removal of the material should any impact be detected. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 6 From a cost benefit standpoint, this project balances maybe a chance of 1 in 10 million risk over 20 years from ground water contamination versus potential fatalities from falls and drownings and the impacts of acid mine drainage. It is important to emphasize the situational aspect of contaminant hazards.

NJ/ NY COAST also is conducting a GIS analysis of dredge sites, AML sites, fly ash generation, and rail connections to identify opportunity sites. Even this demonstration project, which moves dredge material 360 miles, is economically competitive as a means for dredge disposal. More information can be obtained at www. nynjcoast. org.

Part V: OSM Response to EPA's Minefill Regulatory Concerns Document ( Kim Vories, Office of Surface Mining)

OSM has prepared a technical response to EPA's minefill regulatory concerns document. The details of this response are presented in a side by side comparison document, which is included among the meeting materials. The point of OSM's response is to clarify the SMCRA approach, which is presented incompletely in EPA's regulatory concerns document and regulatory reports. From OSM's perspective, all of the 30 CFR potentially applies to CCW mine placement, even though there are few places where the regulations clearly mention CCW. In addition to 30 CFR, each State fills in the details with its own regulatory program as needed and OSM has prepared guidance documents, including the recently published technical reference document entitled Permitting Hydrology, A Technical Reference Document for Determination of Probable Hydrologic Consequences ( PHC) and Cumulative Hydrologic Impact Assessments ( CHIA)   Baseline Data.

OSM recommends that EPA delete the SMCRA approach language currently contained in the regulatory concerns document and replace it with the language from OSM's technical response. OSM presented a brief overview of the details of its technical response, as follows:

° Ground water Monitoring: SMCRA monitoring is permit specific, based on extensive baseline data and the PHC and CHIA. A Site and CCW specific monitoring plan is required.   Well Design and Deployment: permit specific, based on baseline, PHC and CHIA, and operations plan data. The technical reference document identified above contains detailed information on this element.   Parameters: determined on a site specific basis. Analyses must use standard methods.   Frequency: determined on a site specific basis. Data must be submitted every three months.   Duration: until phase III liability, a 5 to 10 year minimum and all reclamation requirements achieved and all State and Federal water quality requirements in compliance. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 7 ° Performance Standards: SMCRA standards include, but are not limited to, the following: minimize disturbance, prevent material damage, protect or replace water rights, support post mining land use. This approach allows operator and regulator creativity.   MCLs and Non degradation: SMCRA requires compliance with all State and Federal water quality laws. Also, in preparation for this meeting, OSM has prepared a detailed response to the following questions: Does SMCRA provide for/ require groundwater standards? If so, where are they in the regs. and/ or statute? What, in fact, are they? How do they line up with MCLs ( as opposed to effluent limits for surface water)? This response is included among the meeting materials.

° Prohibitions: under SMCRA, a permit cannot be approved until the regulatory authority finds that hydrologic performance standards can be met.   Aquifer Avoidance: under SMCRA, a permit cannot be approved until the regulatory authority finds that hydrologic performance standards can be met.   Unacceptable Ash Characteristics: site and CCW specific information is required. SMCRA relies on the expertise of the regulator in determining what characteristics are unacceptable.   Location Restrictions: SMCRA requires extensive detailed baseline information on the environmental resources within the proposed permit area.

° Permitting and Planning: SMCRA includes a comprehensive program.   Acid Base Accounting: this element is not included in existing RCRA regulations. SMCRA, however, requires it and requires measures for protection from acid and toxic forming materials.   Deed Recordation: RCRA regulations require this because RCRA disposal areas change land use potential. SMCRA requires full support for future land use.   Baseline Monitoring: baseline monitoring requirements under SMCRA are extensive.

° Fugitive Dust Control: this element is not included in existing RCRA Subtitle D regulations. SMCRA, however, requires it for certain mines and can require it for all other mines.

° Risk Assessment: this element is not included in existing RCRA regulations. Under SMCRA, however, a permit cannot be approved unless it is demonstrated that the project will not pose a risk.

° Public Participation: SMCRA requires public participation.   Monitoring Information: public availability of monitoring information is not required under existing RCRA Subtitle D regulations. SMCRA, however, requires it.   Citizen Suits: SMCRA provides for citizen lawsuits. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 8 ° Corrective Action: SMCRA requires corrective action.

° Post closure/ Post reclamation Care: EPA's regulatory concerns document suggests care should continue through the time period for which effects may be reasonably expected. However, 25 years of SMCRA and 20 plus years of CCW research demonstrate that impacts may NOT be reasonably expected after Phase III bond release.

Based on this comparison, observations from projects in the field, and research coming in, OSM believes there is no problem with mine placement of CCW. OSM has been incredibly impressed with the State programs in their handling of all the details that are merely concepts in 30 CFR.

Meeting participants had the following questions and comments on this presentation:

° EPA commented that the characterization of RCRA in the regulatory concerns document is based on a potential rule making that has yet to occur. For example, while existing Subtitle D regulations do not cover fugitive dust controls, EPA could propose such controls in a new rule ( and has, for example, in the proposed cement kiln dust rule). The side by side comparison, however, is very helpful.

° In addition to the points mentioned in the OSM presentation, it is not possible to compare siting requirements under RCRA with those of SMCRA because SMCRA sites are, by definition, locations where coal is present.

° In addition to the letter of 30 CFR, OSM has an oversight role in that, if a state program is not sufficient, they can come in to assist.

° Question: If we could establish a level of trust and understanding that States will continue to work with OSM to address problems, then could an additional regulatory regime under RCRA be avoided? ° Answer: EPA has demonstrated a willingness to address issues in that way ( for example, in the oil and gas sector). The Office of Solid Waste is not strictly limited to issuing regulations; it also has the role of promoting environmentally protective beneficial uses. The Agency is open to ideas.

Part VI: State Responses to to EPA's Minefill Regulatory Concerns Document In July, a working group from among the State participants spent two days discussing EPA's regulatory concerns document. The working group agreed that the best response would be to address four key areas that capture the essence of the debate. To this end, members of the working group prepared four draft documents, which are discussed separately below. These are working draft documents, and have not been reviewed by all of the State participants yet. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 9 Matrix of State Regulatory Components ( SMCRA and RCRA) ( Dan Wheeler, Illinois and Craig Kennedy, South Carolina)

Dan Wheeler and Craig Kennedy presented a working draft regulatory matrix and a discussion outline explaining the matrix. These draft documents are included among the meeting materials. In terms of Federal regulatory citations for SMCRA and RCRA, the result is similar to OSM's side by side analysis. The matrix, however, includes citations to two States' regulations, using Illinois as an example of State coal mine regulations and South Carolina as an example of State non coal mine regulations. The presenters emphasized that the matrix is an initial analysis by two individuals and requested comments.

Meeting participants had the following questions and comments:

° EPA commented that the Federal RCRA citations shown are those applicable to municipal solid waste landfills. EPA has provided those citations as examples of the type of regulatory language that might be included in a RCRA regulation for mine placement, if one were proposed. A proposed RCRA regulation, however, is not a certainty and might also be different from the municipal solid waste regulations, particularly in terms of triggers. In either case, it would be misleading to construe these citations as currently applicable to mine placement.

° IMCC asked for reactions from EPA and OSM. Can we/ should we use this document? Is it useful? Would it be helpful for other States to fill in the matrix with citations to their individual regulations? ° One State commented that their responses to the discussion guide from EPA's State visit included the applicable regulatory citations. It might be helpful, however, for those States that EPA did not visit to fill in this matrix. ° Another State commented that some program elements are handled on a site or permitspecific basis, and there is no particular regulatory citation specific to these elements. That might lead someone reviewing the matrix to believe there is a gap in program coverage for a particular State when there really isn't one. ° Another State commented that the addition of more State citations would not resolve the basic issue of differences between the RCRA and SMCRA regulatory approaches. ° EPA commented that the matrix has great visual impact, but it begs the question of the substance and detail behind each citation. From this standpoint, the OSM side by side analysis is more useful. There is no danger in adding States to the matrix, but the result might not be persuasive. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 10 Beneficial Use Versus Disposal ( Susi Ferguson, Texas)

Susi Ferguson presented a working draft document outlining and describing beneficial uses of CCW at mine placement sites. This draft document is included among the meeting materials. The presenter explained that the basic concept behind the document is that an application should be considered beneficial use, as opposed to disposal, when CCW is substituting for a material that would otherwise be used, with no additional environmental impact. The purpose of the document is to define a segment of beneficial uses that the States believe do not require additional regulation aside from the existing regulatory " safety net." The categories of beneficial use covered in the draft document are the following:

( 1) On site construction applications: where CCW is used as a substitute for cement. ( 2) Soil stabilization: where CCW is used to reduce shrink swell ( e. g., in road base). ( 3) Soil amendment/ acid mine drainage: where CCW is used as a substitute for agricultural lime or as an amendment to neutralize coal refuse. ( 4) Structural fill/ compaction: where CCW is used as a substitute to prevent underground mine subsidence, not necessarily for its pozzolanic properties, but for its soil/ aggregate properties. ( 5) Ramp advancement: where CCW is used as a substitute to construct ramps in active mine pits. ( 6) Approximate Original Contour: where CCW is used as an alternative source of reclamation fill instead of spoil/ overburden in cases of shortage.

Meeting participants had the following comments:

° One State suggested that item number 6 should be entitled " use as a non toxic fill," rather than approximate original contour.

° EPA commented that, in the May 2002 Regulatory Determination, it decided additional regulation was not needed for the large scale non minefill beneficial uses primarily because these uses generally involve incorporation into a product or encapsulation. EPA does not need to be convinced that there are benefits to minefilling; the Agency recognizes the subsidence, acid mine drainage, and contouring benefits. For minefilling, particularly as you move to the final three or four categories you've defined, the question remains as to whether there are environmental concerns. If there are potential problems, EPA would balance the environmental impacts versus the benefits. If the potential problems are being adequately addressed, there should be no disruption of the beneficial uses. Also, EPA, as part of its overall regulatory deliberations and determinations regarding CCW, is interested in knowing how it can help the States develop meaningful and appropriate incentives for the environmentally protective beneficial use of CCW, especially with regard to State initiated or  sponsored activities. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 11 Jurisdictional Framework and Diagram ( Mike Menghini, Pennsylvania)

Mike Menghini presented a working draft document outlining the State jurisdictional and regulatory framework concerning CCW placement and utilization. This draft document is included among the meeting materials. The document identifies the regulatory authorities that are generally associated with each of the following types of CCW placement:

° Active coal sites, ° Abandoned mine lands ( AML), ° Non coal sites, and ° Beneficial uses.

Meeting participants had the following questions and comments:

° EPA believes it has a a pretty clear picture of State Federal oversight of active coal sites, but is still unclear about AML sites and non coal mines. ° Regulation of AML sites is discussed in detail as part of the next presentation. ° For non coal mines, federal SMCRA doesn't apply, but there is usually a State regulatory program that applies. This may be either a State SMCRA like program for non coal mines ( as in Pennsylvania) or a separate permit from the State solid waste authority for CCW disposal ( as in Virginia) on a site permitted by State mining authority. Other States offered the following examples:   In Oklahoma, the mining authority has jurisdiction over non coal mine placement, but will not issue a permit until the site has all appropriate permits from the State's water and air authorities.   In Montana, there is shared regulatory jurisdiction between the mining and solid waste programs.   The West Virginia solid waste act exempts mining sites because they are already under the jurisdiction of the mining program. ° EPA also asked about the regulation of abandoned non coal mines. The general response was that this varies from State to State. For example, in South Carolina, if there is an abandoned mine site not covered by mining authority, the operator must characterize the CCW. Unless the CCW characterizes as inert fill, the placement is regulated as industrial solid waste disposal. Oklahoma has one site where no mining ever occurred and this site is permitted under a non coal mine permit.

Placement of Coal Ash at Abandoned Mine Lands ( AML) Sites ( Bruce Stevens, Indiana)

Bruce Stevens presented a working draft document describing the use of CCW in reclamation of AML sites. This draft document is included among the meeting materials. The AML program is under Title IV of SMCRA, while active coal mines are under Title V. The two programs have very different purposes. Title IV covers sites that were abandoned or left in an inadequate reclamation status prior to 1977. Title V regulates post 1977 sites to make sure these sites don't Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 12 become like the abandoned Title IV sites. Title IV is funded by a tonnage fee on coal that is collected by the Department of the Interior, then distributed to the States for use in reclaiming AML sites. While the purpose of the two programs is different, AML projects often employ very similar controls to active mine sites. The design of AML controls, however, is much more site specific, dependent on the specific use. Also, the implementation of the AML program varies from State to State.

The AML program has been widely recognized as the best " white hat" program in the nation, and has done more good than any other program in terms of environmental remediation and public safety. There are a large number of sites, over 5,000 miles of streams affected by acid mine drainage, and over 400,000 acres subject to subsidence. The program incorporates a clean streams program that involves local grassroots efforts. Considering all the good that has come out of the AML program and the fact that there are really no other materials available to use in remediation, it is critical for this group to cover the program in its discussions. There is a real concern that there could be a disincentive for the use of CCW that would threaten the viability of AML reclamation, if CCW is regulated too tightly.

Meeting participants had the following questions and comments:

° Question: where CCW is placed on an AML site with no remining, does OSM have oversight of State regulatory authority? ° Answer: OSM has oversight for State AML programs, so there would be consultation on AML projects.

° States had the following comments about the design of their AML programs:   In Indiana, either the State AML staff designs a remediation project or a coal mine operator proposes something for an adjacent AML site. In most case, once the design is done, it is put out for competitive bid. A coal mine operator or electric utility may come in and complete a project at low cost if it is beneficial for them.   In promulgating its State CCW regulations, the Illinois EPA exempted the AML program because they recognized that the program tries to make a bad situation better. Still, AML projects often apply similar controls to those required under the active mine program.   In West Virginia, AML projects have to go through a NEPA type procedure, involving other State agencies.   North Dakota has some AML sites that are permitted as landfills and regulated by the State Department of Health, which is a bit unique. Also, there are some grouting sites that are using CCW. The State's mining program applies controls to these, especially where there are concerns about groundwater quality. The grout mixes are approved by the Department of Health.   In Pennsylvania, almost all active sites are actually AML sites, but the AML reclamation is accomplished as part of an active mine permit ( i. e., remining).   Ohio's beneficial use program covers both active and AML sites. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 13   In Maryland, reclamation of abandoned non coal mines is regulated under the ground water permit program. Reclamation of abandoned coal mines is covered under the SMCRA Title IV AML program.

Part VII: Discussion of EPA's CCW Regulatory Development Plans From the perspective of IMCC and the State representatives, this process has reached a crossroads. The States have provided a great deal of information, including monitoring data, site visits, regulatory reports, an outline on positions, and the four working draft documents discussed here. This leaves the States with the following questions and concerns:

° The States are uncertain what more EPA wants from them, but would like to know. Is there value in continuing to meet? If so what would be the topic of discussion? ° The States are more convinced than ever that the existing process is adequate. If this is not the case, what would be the most effective way for the States to communicate their position? By specific issue? ° The States do not want to receive an urgent information request six months from now that is difficult to respond to in a timely manner or to hear about EPA moving forward with a decision without the opportunity to be informed of the direction of that decision. ° The States are aware of the four issues identified in the Clean Air Task Force/ Hoosier Environmental Council letter to Marianne Horinko. Is there an additional list of issues important to EPA?

EPA responded to these questions and concerns as follows:

° EPA appreciates the useful products IMCC and the States have provided. ° Although the Agency may come back to the States with issues/ problem areas, it does not mean the Agency does not recognize the potential benefits of mine placement. ° There are a number of analytical steps EPA still needs to complete. These include:   Finalizing the State Regulatory Program Analysis Reports, incorporating information from the most recent State visits and any outstanding State comments.   Additional work on the MRAM project, including a determination of how much additional data and information is needed to complete the analysis.   A meeting with the environmental community to further discuss their concerns. EPA's inclination would be to include OSM and IMCC in this meeting.   EPA would welcome additional information regarding regulation and environmental impacts of non coal mine placement.   EPA retains an open mind about efforts to increase environmentally protective beneficial use of CCW and would welcome ideas in this area. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 14 The mention of a meeting with the environmental community prompted additional discussion, which included the following points:

° Question: could the meeting include State environmental groups that have been supportive of State reclamation programs? ° Answer: Yes.

° Question: Are the environmental community's issues primarily related to process/ public involvement or to technical standards? ° Answer: Both, but it is most important to get their feedback on what technical standards they would like to see, based on the information that is available about existing standards.

° It will be important to set out what the agenda and discussion points are going to be for such a meeting in advance so that participants are prepared to discuss the issues at hand.

° It was noted that industry has requested representation at past meetings as well. A proposal was made for a sequential meeting: one day involving the environmental community, one day involving the industry, and one day of follow up among the State and Federal regulators.

Part VIII: Next Steps Key Next Steps The following were identified as key next steps:

° States should comment on EPA's draft site visit reports and discussion guides.

The final reports from the States visited should be available on the EPA web site by the end of the year. To the extent that States that were not visited want to respond to EPA's discussion guide, it would be welcomed.

° The State participants should finalize the working draft documents presented here.

For the final three documents, comments should be sent to the authors within 30 days after these meeting notes are published. For the second document ( beneficial use versus disposal) there may be a change in format, so that document may require a second iteration of comments after the first revision. There was some discussion of the first working draft document ( regulatory matrix). The addition of regulatory citations from additional States might not be the best use of time, but the Federal RCRA and SMCRA citations should be included in the side by side analysis prepared by OSM. It was proposed that the regulatory matrix be merged with the third working draft document ( jurisdictional framework). Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 15 ° Set up the next meeting to include the environmental community.

This meeting should be arranged for sometime after the start of next year. The agenda should be developed in advance and State attendees identified to make sure there is representation ( regional, SMCRA, RCRA, coal, non coal) without being uncomfortably large. Should this be a 3 session program ( i. e., one session each for the environmental community, industry, and State and Federal representatives)? Make sure we give comment and finalize state regulatory documents.

Discussion Issues IMCC presented a list of the issues likely to be raised at the next meeting. The first four of these are from the Clean Air Task Force/ Hoosier Environmental Council letter to Marianne Horinko. The purpose of this list is not to limit the agenda for the meeting, but to prepare for what might be discussed. The list is as follows:

° Placement of CCW in ground water ° Ground water monitoring ° Post closure monitoring, financial assurance, and corrective action ° Lack of restrictions for post reclamation use of property ° Imbalance among State programs ° Acid forming materials and acid mine drainage There was further discussion of the first issue, placement in ground water. This issue is of concern to EPA, particularly given the presence of this factor at the sand and gravel damage case sites. EPA would like some response to the question of why the problems that occurred at those sites might not happen at coal mine sites or sites under current regulations. OSM noted that it presented a discussion on a response to environmental concerns in a paper presented at its Technical Interactive Forum on " Coal Combustion By Products and Western Coal Mines" in Golden Colorado in April of 2002. This document is included among the meeting materials. It would also be useful to receive a response from State solid waste programs and the Association of State and Territorial Solid Waste Management Officials ( ASTSWMO). A format for such response might be to analyze the damage cases as hypotheticals, and show how a given program would evaluate such a proposed scenario and prevent similar damage.

MRAM Concerns There was also additional discussion of State concerns regarding the MRAM project, including the following topics:

° How do you anticipate using the data in the regulatory determination process? Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 16 The States were concerned about conflicting information on the timing and track of MRAM with regard to the regulatory determination. EPA clarified that further discussions at EPA would take place regarding the future MRAM analyses, the timing, and its use.

° The States have the following " conditions" for providing additional data: they need to understand ( 1) how the data will be used, ( 2) how it will be analyzed, and ( 3) their role in determining its use, the methodology for analysis, and the conclusions drawn from it.

Based on the presentation summarized under Part III, above, States are concerned about what the project is looking at. Specifically, is the analysis using the right parameters and comparisons, given the concerns? For example, some of the parameters analyzed ( sulfate, iron, aluminum) can be mining related, not ash related. There are concerns that conclusions are being drawn without looking at the big picture of the analysis, that raw data is being presented without an analysis, and that the methodology is not clear. States would like some input on how the data is interpreted, so the selected sites are analyzed in a complete manner and based on information from those familiar with the sites. The data need to be evaluated in a manner that's defensible. EPA responded that these comments are clear and well taken, and committed to providing more information to the States on the MRAM project.

Non Coal Mine Concerns There was also discussion of how to best address non coal mine concerns. Suggestions included:

° An expanded matrix of regulatory citations specific to the non coal sector. ° A side by side analysis for non coal regulations similar to that prepared by OSM. ° A process of benchmarking or review of regulatory information. ° A technical guidance document or demonstration of equivalent performance standards to those contained in the Industrial D guidance or some other Federal guidance. ° A focus on several key issues.

EPA responded that its State Regulatory Program Analysis Reports include review of non coal mine regulations and States should review and comment on these sections of the reports. It also would be helpful for States to evaluate the non coal mine ( sand and gravel pit) damage cases as discussed above under placement in ground water   analyze these cases as hypotheticals, and show how a given non coal regulatory program would evaluate such a proposed scenario and prevent similar damage. To this end, EPA committed to providing the States detailed information on the sand and gravel damage cases. Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 17 Remaining EPA Concerns/ Issues Finally, the States want to understand EPA's primary concerns in the following specific areas:

° Risk assessment   Question: RCRA Part 258 does not include risk assessment, so what brought it up in this case and is this an element likely to be added for CCW mine placement?   Answer: If EPA decides to promulgates a regulation, it will likely be an element.

  Question: What type of risk assessment is EPA contemplating in its regulatory concerns document? The PHC and CHIA performed under SMCRA can be considered a risk assessment, even though they are not called that. But they are not, in a strict sense, what EPA calls a formal risk assessment. Therefore, would risk assessment be a formal ( potentially expansive and expensive) process that involves a great deal of toxicology and modeling or the type of risk assessment that already occurs under the PHC and CHIA?   Answer: The Office of Solid Waste would likely defer to the Clean Water Act to control impacts to surface water and focus on ground water impacts. Therefore, this should be a part of what is already done under SMCRA. The assessment should consider both CCW characteristics and site characteristics and determine whether key constituents present in CCW would adversely impact ground water.

° Material damage   Question: Does it trouble EPA that there's no specific definition of this SMCRA concept, but that it is an element of analysis interpreted on a case by case basis?   Answer: The environmental community views this concept as vague and confusing. We should discuss this further with them.

° Post closure care EPA commented that the Agency's decision on this depends on the evaluation of whether up front planning is sufficiently protective. It may be the case that if a project is designed to correct a problem and there is no potential for long term issues, post closure care becomes less of an issue. If, however, a remediation project involves something that is long term in nature ( e. g. AMD treatment), an alternate means of financial assurance beyond the SMCRA bond might be required. EPA would like input on why this should be viewed from a solid waste perspective versus a reclamation/ remediation perspective. Also, if there's going to be a long term groundwater monitoring program, should it be done separately from SMCRA program, allowing that bond and permit to terminate? Meeting Notes: Williamsburg * DRAFT  11/ 27/ 02* Page 18 ° Monitoring There was no additional discussion of this issue.

Action Items ° EPA, IMCC, and OSM will plan the next meeting, to include the environmental community, for after the first of the year. ° The States have one final opportunity to review EPA's State Regulatory Program Analysis Reports. ° States will have the opportunity to examine all of EPA's State visit reports and discussion guides. ° States that were not visited are welcome to prepare their own responses to the discussion guide. ° The States will finalize the working draft documents presented here before the next meeting. ° EPA will provide additional information on the MRAM project. ° EPA will make available detailed information on the sand and gravel damage cases.

Meeting Materials available on EPA's web site at www. epa. gov/ epaoswer/ other/ fossil/ index. htm:

° Meeting Attendees ° EPA's MRAM Presentation Slides ° OSM's Side by Side Comparison of RCRA to SMCRA ° OSM's Response to Questions Regarding Ground water Standards Under SMCRA ° States' Working Draft Regulatory Matrix ° Discussion Outline for States' Working Draft Regulatory Matrix ° States' Working Draft Description of Beneficial Uses ° States' Working Draft CCB Placement and Utilization Jurisdictional Framework and Diagram ° States' Working Draft on Placement of Coal Ash at Abandoned Mine Land Sites ° OSM's Response to Environmental Concerns


[Federal Register Volume 78, Number 71 (Friday, April 12, 2013)]
[Notices]
[Page 21938]
[FR Doc No: 2013-08661]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9008-6]

Environmental Impacts Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly receipt of Environmental Impact Statements
Filed 04/01/2013 Through 04/05/2013
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20130086, Revised Final EIS, USFS, ID, Lower Orogrande, North
Fork Ranger District, Clearwater National Forest, Review Period Ends:
05/28/2013, Contact: George Harbaugh<PHONE_NUMBER>.
EIS No. 20130087, Draft EIS, BLM, NM, TriCounty Resource Management
Plan, Comment Period Ends: 07/11/2013, Contact: Jennifer Montoya 575-
525-4316.
EIS No. 20130088, Final Supplement, BOEM, 00, Gulf of Mexico OCS Oil
and Gas Lease Sales: 2013-2014 Western Planning Area Lease Sale 233
Central Planning Area Lease Sale 231, Review Period Ends: 05/13/2013,
Contact: Poojan B. Tripathi<PHONE_NUMBER>.

Amended Notices

EIS No. 20130041, Draft EIS, USFS, AZ, Salt River Allotments Vegetative
Management, Comment Period Ends: 05/08/2013, Contact: Debbie Cress 928-
467-3220, Revision to FR Notice Published 02/22/2013; Extending Comment
Period from 04/08/2013 to 05/08/2013.
EIS No. 20130047, Draft EIS, NPS, FL, Everglades National Park Draft
General Management Plan/East Everglades Wilderness Study, Comment
Period Ends: 05/13/2013, Contact: Eric Thuerk<PHONE_NUMBER>, Revision to
FR Notice Published 03/01/2013; Extending Comment Period from 4/15/2013
to 5/13/2013.

    Dated: April 9, 2013.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2013-08661 Filed 4-11-13; 8:45 am]
BILLING CODE 6560-50-P


P-20-0054 Sanitized Support Documents Index:
 P-20-0054 Sanitized Determination Document (linked)
 P-20-0054 Sanitized CHEM Report (attached)
 P-20-0054 Sanitized ECO Report (attached)
 P-20-0054 Sanitized ENG Report (attached)
 P-20-0054 Sanitized EXP Report (attached)
 P-20-0054 Sanitized Fate Report (attached)
 P-20-0054 Sanitized HLTH Report_POST-FOCUS FINAL (attached)


parathion ( CAS No. 56 38 2) An organophosphate pesticide used to control many insects and mites. Trade names for parathion include AC 3422, Alkron, Alleron, Aphamite, Corothion, E 605, ENT 15108, Ethyl parathion, Etilon, Fosferno 50, Niran, Orthophos, Panthion, Paramar, Paraphos, Parathene, Parawet, Phoskil, Rhodiatox, Soprathion, Stathion, and Thiophos.

percentile The set of divisions that produce exactly 100 equal parts in a series of continuous values.

phorate ( CAS No. 298 02 2) A toxic, clear liquid used as an insecticide.

phosmet ( CAS No. 732 11 6) An organophosphate pesticide mainly used on apple trees, although it is also used on a other fruit crops, ornamentals, and vines to control aphids, suckers, mites, moths, and fruit flies. The compound is also an active ingredient in some pet collars. Trade names for phosmet include Appa, Decemtion, Fesdan, Imidan, Kemolate, Prolate, PMC, and Safidon.

phthalates A family of chemicals used primarily as plasticizers that are added to products to make them soft or flexible.

pigment A natural or synthetic substance that is used to transfer color to another substance.

platinum ( CAS No. 7440 06 4) A silver gray, lustrous metal found naturally in the earth's crust. Platinum and the compounds it forms resist corrosion and can withstand high temperatures.

pollutant Any substance or agent that causes pollution.

polyaromatic hydrocarbons ( PAHs) A group of more than 100 different chemicals that are formed during the incomplete burning of coal, oil, gas, garbage, or other organic substances, including tobacco or charbroiled meat. PAHs are found in soot, coal tar, crude oil, creosote, and roofing tar. Some PAHS are used in medicines, dyes, plastics, and pesticides. 58 polychlorinated biphenyls ( PCBs) A group of manufactured organic chemicals that contain 209 individual chlorinated chemicals ( known as congeners). PCBs are oily liquids or solids and range from being colorless to light yellow. Products containing PCBs are old fluorescent lighting fixtures; electrical appliances containing PCB capacitators; old microscope oil; and hydraulic fluids, paints, inks, adhesives, electrical condensers, batteries, and lubricants.

reference range A set of numerical quantities that serves as a base against which further quantities are measured.

sample A portion of a population that is observed to make generalizations about the whole population.

sample size The number of units ( such as people or animals) in a population to be studied. If a scientist surveys 200 people about their pesticide use, the sample size would be 200.

serum The liquid portion of blood that remains after the removal of clotting proteins and blood cells.

substrate A compound that reacts with a substance.

temephos ( CAS No. 3383 96 8) An organophosphate pesticide used to control mosquito, midge, and black fly larvae. Temephos is used on lakes, ponds, and wetlands. It is also used to control fleas on dogs and cats and to control lice on humans. Trade names for temephos include Abat, Abate, Abathion, Acibate, Biothion, Difennthos, Ecopro, Nimitox, and Swebate.

thallium ( CAS No. 7440 28 0) A blue white metal that is found in the earth's crust. Thallium is found in small amounts in soil and rocks. In the past, thallium was obtained as a byproduct of smelting other metals; however, it has not been produced in the United States since 1984.

thermocouple A device consisting of two different metallic conductors that are connected at both ends, producing a loop in which heat is converted into electrical current. A thermocouple is used to measure the temperature of a substance.

toxicant A toxic or poisonous substance.

tungsten ( CAS No. 7440 33 7) A steel gray to tin white metal found naturally in the earth's crust. This metal is highly flammable and may catch fire spontaneously when exposed to air. Tungsten may be combined with other chemicals such as carbon. Tungsten is also called wolfram. 59 uranium ( CAS No. 7439 97 6) A silver white, extremely dense radioactive metal. Uranium almost never occurs by itself but rather in combination with oxygen, chlorine, or fluorine.

volatile organic compounds ( VOCs) Organic compounds that evaporate readily into the air. VOCs are released when cars or other machines burn fuel. VOCs contribute significantly to smog production. VOCs include chemicals such as benzene, toluene, methylene chloride, and methyl chloroform and can cause serious health problems.

zinc ( CAS No. 7440 66 6) One of the most common elements in the earth's crust. Zinc is found in air, soil, and water and is present in all foods. Pure zinc is a blue white, shiny metal. Zinc is used in coatings to prevent rust and in dry cell batteries. It is also mixed with other metals to make alloys such as brass and bronze. A zinc and copper alloy is used to make pennies in the United States. Zinc compounds are widely used in industry to make paint, rubber, dye, wood preservatives, and ointments. Centers for Disease Control and Prevention National Center for Environmental Health Division of Laboratory Sciences Mail Stop F 20 4770 Buford Highway, N. E. Atlanta, Georgia 30341 3724 Telephone ( toll free): 1 866 670 6052 E mail: ncehdls@ cdc. gov Web site: www. cdc. gov/ nceh/ dls/ report March 2001 NCEH Pub. No. 01 0379


[Federal Register Volume 79, Number 236 (Tuesday, December 9, 2014)]
[Notices]
[Page 73065]
[FR Doc No: 2014-28756]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 9709-065]

Trafalgar Power, Inc., ECOsponsible, LLC; Notice of Application
for Transfer of License and Soliciting Comments and Motions To
Intervene

    On October 13, 2014 and supplemented on November 24, 2014,
Trafalgar Power, Inc. (transferor) and ECOsponsible, LLC (transferee)
filed an application for transfer of license of the Herkimer Project,
FERC No. 9709. The project is located on the West Canada Creek in
Herkimer County, New York.
    The transferor and transferee seek Commission approval to transfer
the license for the Herkimer Project from the transferor to the
transferee.
    Applicant Contact: For Transferor: Mr. Arthur Steckler, President,
Trafalgar Power, Inc., 11010 Lake Grove Blvd., Suite 100, Box 353,
Morrisville, NC 27560-7392. For Transferee: Mr. Dennis Ryan, President,
ECOsponsible, Inc., Managing Member, ECOsponsible, LLC, 469 Snyder
Road, East Aurora, NY 14052, phone<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    Deadline for filing comments and motions to intervene: 30 days from
the issuance date of this notice, by the Commission. The Commission
strongly encourages electronic filing. Please file motions to intervene
and comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your name and contact information at the end of your
comments. For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number P-9709-065.

    Dated: December 1, 2014.
Kimberly D. Bose,
 Secretary.
[FR Doc. 2014-28756 Filed 12-8-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 138 (Friday, July 17, 2020)]
[Notices]
[Pages 43591-43592]
[FR Doc No: 2020-15337]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2020-0021; OMB No. 1660-0118]

Agency Information Collection Activities: Submission for OMB
Review; Comment Request; Homeland Security Exercise and Evaluation
Program (HSEEP) Documentation

AGENCY: Federal Emergency Management Agency, Homeland Security (DHS).

ACTION: 30 Day notice and request for comments.

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

SUMMARY: The Federal Emergency Management Agency (FEMA) will submit the
information collection abstracted below to the Office of Management and
Budget for review and clearance in accordance with the requirements of
the Paperwork Reduction Act of 1995. The submission will describe the
nature of the information collection, the categories of respondents,
the estimated burden (i.e., the time, effort and resources used by
respondents to respond) and cost, and the actual data collection
instruments FEMA will use.

DATES: Comments must be submitted on or before August 17, 2020.

ADDRESSES: Written comments and recommendations for the proposed

information collection should be sent 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: Kate Bogan, National Exercise
Division, Analytics and Narrative Management Section Chief, 400 C
Street SW, Washington, DC 20024, (telephone)<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>Requests for additional information or copies
of the information collection should be made to Director, Information
Management Division, email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This proposed information collection
previously published in the Federal Register on April 24, 2020, at 85
FR 23054 with a 60 day public comment period. No comments were
received. The purpose of this notice is to notify the public that FEMA
will submit the information collection abstracted below to the Office
of Management and Budget for review and clearance.

Collection of Information

    Title: Homeland Security Exercise and Evaluation Program (HSEEP)
Documentation.
    Type of information collection: Extension, without change, of a
currently approved information collection.
    OMB Number: 1660-0118.
    Form Titles and Numbers: FEMA Form 091-0, After Action Report/
Improvement Plan (AAR/IP); FEMA Form 008-0-26, Multi-Year Training
Exercise Plan (TEP); FEMA Form 008-0-27, National Exercise Program
(NEP) Nomination Form.
    Abstract: The Homeland Security Exercise and Evaluation Program
(HSEEP) Documentation collection provides reporting on the results of
preparedness exercises and provides assessments of the respondents'
capabilities so that strengths and areas for improvement are
identified, corrected, and shared as appropriate prior to a real
incident. This information is also required to be submitted as part of
certain FEMA grant programs.
    Affected Public: State, local, or Tribal governments.
    Estimated Number of Respondents: 268.
    Estimated Number of Responses: 704.
    Estimated Total Annual Burden Hours: 23,208 hours.
    Estimated Total Annual Respondent Cost: $1,469,995.
    Estimated Respondents' Operation and Maintenance Costs: 0.
    Estimated Respondents' Capital and Start-Up Costs: 0.
    Estimated Total Annual Cost to the Federal Government: $67,950.

Comments

    Comments may be submitted as indicated in the ADDRESSES caption
above. Comments are solicited to (a) evaluate whether the proposed data
collection is necessary for the proper performance of the agency,
including whether the information shall have practical utility; (b)
evaluate the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) enhance the quality, utility, and
clarity of the information to be collected; and (d) minimize the burden
of the collection of information on those who are to respond, including
through the use of appropriate automated, electronic, mechanical, or
other technological collection techniques or other forms of information
technology, e.g., permitting electronic submission of responses.

Maile Arthur,
Acting Records Management Branch Chief, Office of the Chief
Administrative Officer, Mission Support, Federal Emergency Management
Agency, Department of Homeland Security.
[FR Doc. 2020-15337 Filed 7-16-20; 8:45 am]
BILLING CODE 9111-27-P


[Federal Register Volume 86, Number 234 (Thursday, December 9, 2021)]
[Rules and Regulations]
[Pages 69998-70000]
[FR Doc No: 2021-26605]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0783; Project Identifier 2019-SW-009-AD; Amendment
39-21825; AD 2021-24-04]
RIN 2120-AA64

Airworthiness Directives; Bell Textron Canada Limited (Type
Certificate Previously Held by Bell Helicopter Textron Canada Limited)
Helicopters

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: The FAA is adopting a new airworthiness directive (AD) for
certain Bell Textron Canada Limited (type certificate previously held
by Bell Helicopter Textron Canada Limited) Model 505 helicopters. This
AD was prompted by the determination that reducing the pressure
altitude limitations for certain fuel types is necessary. This AD
requires revising the existing Rotorcraft Flight Manual (RFM) for your
helicopter. The FAA is issuing this AD to address the unsafe condition
on these products.

DATES: This AD is effective January 13, 2022.
    The Director of the Federal Register approved the incorporation by
reference of a certain document listed in this AD as of January 13,
2022.

ADDRESSES: For service information identified in this final rule,
contact Bell Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel,
Quebec J7J 1R4, Canada; telephone 1-450-437-2862 or 1-800-363-8023; fax
1-450-433-0272; email [email protected]; or at https://www.bellflight.com/support/contact-support. You may view 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 information on the availability of this material at the FAA,
call<PHONE_NUMBER>. It is also available at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0783.

Examining the AD Docket

    You may examine the AD docket at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0783; 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 final rule, the
Transport Canada AD, any comments received, and other information. The
street address for Docket Operations is U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Rao Edupuganti, Aerospace Engineer,
Dynamic Systems Section, Technical Innovation Policy Branch, Policy &
Innovation Division, FAA, 10101 Hillwood Pkwy., Fort Worth, TX 76177;
telephone<PHONE_NUMBER>; email [email protected].

SUPPLEMENTARY INFORMATION:

Background

    The FAA issued a notice of proposed rulemaking (NPRM) to amend 14
CFR part 39 by adding an AD that would apply to certain Bell Textron
Canada Limited (type certificate previously held by Bell Helicopter
Textron Canada Limited) Model 505 helicopters. The NPRM published in
the Federal Register on September 20, 2021 (86 FR 52109). In the NPRM,
the FAA proposed to require revising the existing RFM for your
helicopter. Incorporating the RFM revision may be performed by the
owner/operator (pilot) holding at least a private pilot certificate and
must be entered into the aircraft records showing compliance with this
AD in accordance with 14 CFR 43.9(a)(1) through (4) and 14 CFR
91.417(a)(2)(v). The record must be maintained as required by 14 CFR
91.417, 121.380, or 135.439. This is an exception to the FAA's standard
maintenance regulations.
    The NPRM was prompted by Canadian AD CF-2019-08, dated March 5,
2019 (Canadian AD CF-2019-08), issued by Transport Canada, which is the
aviation authority for Canada, to correct an unsafe condition for Bell
Helicopter Textron Canada Limited Model 505 helicopters serial numbers
65011 and subsequent. Transport Canada advises of the need to reduce
the altitude limitations for Jet B and JP-4 wide-cut fuels following
unsatisfactory performance of the engine at the original higher
altitude limitations with these wide-cut fuels. This condition, if not
addressed, could result in low fuel pressure, engine flame-out, or
engine power interruption (a change in any engine performance
parameter--including but not limited to gas generator speed, power
turbine speed, main gas temperature, or output torque--outside its
normal limits for the prevailing operating conditions).
    Accordingly, Canadian AD CF-2019-08 requires revising the RFM to
reflect the reduced altitude operating limitations for Jet B and JP-4
wide-cut fuels.

Discussion of Final Airworthiness Directive

Comments

    The FAA received no comments on the NPRM or on the determination of
the costs.

Conclusion

    These helicopters have been approved by the aviation authority of
Canada and are approved for operation in the United States. Pursuant to
the FAA's bilateral agreement with Canada, Transport Canada, its
technical representative, has notified the FAA of the unsafe condition
described in its AD. The FAA reviewed the relevant data and determined
that air safety requires adopting this AD as proposed. Accordingly, the
FAA is issuing this AD to address the unsafe condition on these
helicopters. Except for minor editorial changes, this AD is adopted as
proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    The FAA reviewed Figure 1-6. Fuel Operating Envelope (Sheet 1 of 1)
of Bell 505 Rotorcraft Flight Manual BHT-505-FM-1, Revision 3, dated
July 25, 2018, which specifies limitations, normal and emergency
procedures, performance data, weight and balance information, and
provides a list of approved optional equipment supplements. This
revision of the service information includes an updated figure of the
fuel operating envelope showing the reduced pressure altitude
limitations for Jet B and JP-4 fuels.
    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.

Differences Between This AD and the Transport Canada AD

    Canadian AD CF-2019-08 requires updating the RFM to Bell 505 RFM
BHT-505-FM-1 Revision 3 or later revisions approved by Transport
Canada, whereas this AD requires revising the Limitations Section of
the RFM for your helicopter by replacing the existing Figure 1-6. with
Figure 1-6. Fuel Operating Envelope (Sheet 1 of 1) of Bell 505 RFM BHT-
505-FM-1, Revision 3, dated July 25, 2018.

Costs of Compliance

    The FAA estimates that this AD affects 73 helicopters of U.S.
Registry. Labor rates are estimated at $85 per work-hour. Based on
these numbers, the FAA estimates the following costs to comply with
this AD.
    Revising the existing RFM for your helicopter would take about 0.5
work-hour for an estimated cost of $43 per helicopter or $3,139 for the
U.S. fleet.

Authority for This Rulemaking

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

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Will not affect intrastate aviation in Alaska, and
    (3) 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.

List of Subjects in 14 CFR Part 39

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

The Amendment

    Accordingly, under the authority delegated to me by the
Administrator,

the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

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

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

Sec.  39.13  [Amended]

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

2021-24-04 Bell Textron Canada Limited (Type Certificate Previously
Held by Bell Helicopter Textron Canada Limited): Amendment 39-21825;
Docket No. FAA-2021-0783; Project Identifier 2019-SW-009-AD.

(a) Effective Date

    This airworthiness directive (AD) is effective January 13, 2022.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Bell Helicopter Textron Canada Limited (type
certificate previously held by Bell Helicopter Textron Canada
Limited) Model 505 helicopters having serial number 65011 and
subsequent, certificated in any category.

(d) Subject

    Joint Aircraft Service Component (JASC) Code: 7300, Engine fuel
and control.

(e) Unsafe Condition

    This AD was prompted by the determination that reducing the
pressure altitude limitations for certain fuel types is necessary.
The FAA is issuing this AD to address unsatisfactory flight
performance of the engine above pressure altitude limitations for
Jet B and JP-4 fuels. The unsafe condition, if not addressed, could
result in low fuel pressure, engine flame-out, or engine power
interruption.

(f) Compliance

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

(g) Required Actions

    Within 30 calendar days after the effective date of this AD,
revise the Limitations Section of the existing Rotorcraft Flight
Manual (RFM) for your helicopter by replacing Figure 1-6. with
Figure 1-6. Fuel Operating Envelope (Sheet 1 of 1) of Bell 505
Rotorcraft Flight Manual BHT-505-FM-1, Revision 3, dated July 25,
2018 (BHT-505-FM-1 Revision 3). Using a different document with
information identical to that in Figure 1-6. Fuel Operating Envelope
(Sheet 1 of 1) of BHT-505-FM-1 Revision 3 is acceptable for
compliance with the requirements of this AD. The action required by
this paragraph may be performed by the owner/operator (pilot)
holding at least a private pilot certificate and must be entered
into the aircraft records showing compliance with this AD in
accordance with 14 CFR 43.9(a)(1) through (4) and 14 CFR
91.417(a)(2)(v). The record must be maintained as required by 14 CFR
91.417, 121.380, or 135.439.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, International Validation Branch, FAA, has the
authority to approve AMOCs for this AD, if requested using the
procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19,
send your request to your principal inspector or local Flight
Standards District Office, as appropriate. If sending information
directly to the manager of the International Validation Branch, send
it to the attention of the person identified in paragraph (i)(1) of
this AD. Information may be emailed to: [email protected].
    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(i) Related Information

    (1) For more information about this AD, contact Rao Edupuganti,
Aerospace Engineer, Dynamic Systems Section, Technical Innovation
Policy Branch, Policy & Innovation Division, FAA, 10101 Hillwood
Pkwy., Fort Worth, TX 76177; telephone<PHONE_NUMBER>; email
[email protected].
    (2) The subject of this AD is addressed in Transport Canada AD
CF-2019-08, dated March 5, 2019. You may view the Transport Canada
AD at https://www.regulations.gov in Docket No. FAA-2021-0783.

(j) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference of the service information listed in this
paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless the AD specifies otherwise.
    (i) Figure 1-6. Fuel Operating Envelope (Sheet 1 of 1) of Bell
505 Rotorcraft Flight Manual BHT-505-FM-1, Revision 3, dated July
25, 2018.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact Bell
Textron Canada Limited, 12,800 Rue de l'Avenir, Mirabel, Quebec J7J
1R4, Canada; telephone 1-450-437-2862 or 1-800-363-8023; fax 1-450-
433-0272; email [email protected]; or at https://www.bellflight.com/support/contact-support.
    (4) You may view this service information at the FAA, Office of
the Regional Counsel, Southwest Region, 10101 Hillwood Pkwy., Room
6N-321, Fort Worth, TX 76177. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, email: [email protected], or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on November 12, 2021.
Gaetano A. Sciortino,
Deputy Director for Strategic Initiatives, Compliance & Airworthiness
Division, Aircraft Certification Service.
[FR Doc. 2021-26605 Filed 12-8-21; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 23 (Tuesday, February 4, 2020)]
[Notices]
[Pages 6203-6205]
[FR Doc No: 2020-02101]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-N-6050]

Food and Drug Administration/Federal Trade Commission Workshop on
a Competitive Marketplace for Biosimilars; Public Workshop; Request for
Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of workshop; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we), in
collaboration with the Federal Trade Commission (FTC), is announcing a
public workshop on March 9, 2020, ``FDA/FTC Workshop on a Competitive
Marketplace for Biosimilars.'' The purpose of the public workshop is to
discuss FDA and FTC's collaborative efforts to support appropriate
adoption of biosimilars, discourage false or misleading communications
about biosimilars, and deter anticompetitive behaviors in the biologic
product marketplace.

DATES: The public workshop will be held on March 9, 2020, from 9 a.m.
to 5 p.m. Persons seeking to speak at the public workshop must register
by February 24, 2020. Persons seeking to attend but not speak at the
public workshop must register by March 4, 2020. Section III provides
attendance and registration information. Electronic or written comments
will be accepted until April 9, 2020.

ADDRESSES: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503A), Silver Spring, MD 20993-0002. Entrance for the public
workshop participants (non-FDA employees) is through Building 1 where
routine security check procedures will be performed. For parking and
security information, please refer to https://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before April 9, 2020. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end April 9, 2020. Comments received by mail/hand delivery/
courier (for written/paper submissions) will be considered timely if
they are postmarked or the delivery service acceptance receipt is on or
before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2019-N-6050 for ``FDA/FTC Workshop on a Competitive Marketplace for
Biosimilars.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' FDA will review
this copy, including the claimed confidential information, in its
consideration of comments and will share it with FTC. The second copy,
which will have the claimed confidential information redacted/blacked
out, will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Sandra Benton, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New

Hampshire Ave., Bldg. 75, Rm. 6522, Silver Spring, MD 20993-0002, 301-
796-1042, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA, in collaboration with FTC, is announcing the following public
workshop entitled ``FDA/FTC Workshop on a Competitive Marketplace for
Biosimilars.'' The purpose of the public workshop is to discuss FDA and
FTC's collaborative efforts to support appropriate adoption of
biosimilars, discourage false or misleading communications about
biosimilars, and deter anticompetitive behaviors in the biologic
product marketplace.
    FDA, an agency within the U.S. Department of Health and Human
Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines,
and other biological products for human use, and medical devices. The
Agency is also responsible for the safety and security of our nation's
food supply, cosmetics, dietary supplements, and products that emit
electronic radiation, and for regulating tobacco products. Congress has
given FDA, as part of the Agency's mission to promote and protect the
public health, responsibility for implementing laws intended to strike
a balance between encouraging and rewarding innovation in drug and
biological product development and facilitating robust and timely
market competition for drugs and biological products.
    FDA regulates biological products under the Public Health Service
Act (PHS Act) (see 42 U.S.C. 262) and the Food, Drug, and Cosmetic Act
(21 U.S.C. 355). This includes review and approval of biosimilar and
interchangeable products pursuant to an abbreviated licensure pathway
added to the PHS Act in the Biologics Price Competition and Innovation
Act of 2009 (BPCI Act),\1\ which allows an applicant seeking licensure
of a proposed biosimilar or interchangeable product to leverage FDA's
previous determination of safety and effectiveness for a reference
product licensed under section 351(a) of the PHS Act provided the
sponsor can demonstrate that the biosimilar or interchangeable product
meets the statutory standards for approval. The BPCI Act was enacted
with the intent to balance innovation and consumer interests.\2\ FDA
has and will continue to play a critical role in facilitating increased
access to biosimilars, by supporting robust and timely competition
through, among other things, the efficient review of applications for
biosimilar and interchangeable products, which in turn may help enhance
patient access and reduce cost burdens on patients and our healthcare
system, in addition to helping to ensure the United States remains a
driving force in medical innovation. Part of that role includes helping
to ensure communication of truthful, nonmisleading, and balanced
information about biological products, through FDA's oversight of
prescription drug labeling and advertisements by drug manufacturers,
packers and distributors and those acting on their behalf, and through
FDA's own communications. This workshop will help to advance these
important FDA priorities.
---------------------------------------------------------------------------

    \1\ Sections 7001 through 7003 of the Patient Protection and
Affordable Care Act (ACA) (Pub. L. 111-148). See also Biosimilars
Action Plan, https://www.fda.gov/media/114574/download.
    \2\ Id., section 7001(b) of the ACA.
---------------------------------------------------------------------------

    FTC is an independent agency charged by Congress with protecting
the interests of consumers by enforcing competition and consumer
protection laws. (See Federal Trade Commission Act, 15 U.S.C. 41-58.)
It exercises primary responsibility for civil antitrust enforcement in
the pharmaceutical industry. (For a summary of FTC's antitrust actions
in the pharmaceutical industry, see https://www.ftc.gov/system/files/attachments/competition-policy-guidance/overview_pharma_june_2019.pdf.)
FTC also protects consumers by enforcing laws and rules that promote
truth in advertising and fair business practices. FTC has substantial
experience evaluating the generic drug and biosimilar marketplaces.
    FTC vigorously promotes competition in the healthcare industry
through enforcement, study, and advocacy. Competition in healthcare
markets benefits consumers by helping to: (1) Control costs and prices;
(2) improve quality of care; (3) promote innovative products, services,
and delivery models; and (4) expand access to healthcare goods and
services. One of the FTC's long-standing core missions is to ensure
advertising is truthful and not misleading. This allows consumers to
make well-informed decisions about how best to use their resources and
promotes the efficient functioning of market forces by encouraging the
dissemination of accurate information. As addressed below, this
proposed workshop is consistent with these FTC priorities.
    As the marketplace of biological products continues to expand and
evolve, FDA and FTC expect an increase in promotional activities
involving reference products and biosimilar and interchangeable
products. FDA, in collaboration with FTC, supports and encourages
competitive markets for biological products. Supporting a competitive
marketplace for biological products including biosimilar and
interchangeable products, is essential for patient access to medicines
and reducing healthcare costs. Biological products play a critical role
in the treatment of many serious illnesses, including rare genetic
disorders, autoimmune diseases, and cancer. For many of these
conditions, there are no treatment alternatives other than biological
products.
    Both FDA and FTC have serious concerns about false or misleading
communications regarding reference products and biosimilar or
interchangeable products, and the potential negative effects of such
communications on public health and competition. False or misleading
comparisons of reference products and biosimilar or interchangeable
products may constitute unfair or deceptive practices that undermine
confidence in biosimilar and interchangeable products. Both agencies
want to ensure that healthcare professionals and patients receive
truthful and nonmisleading information about biological products.
    This public workshop is a component of FDA's broader effort to
facilitate the growth of a competitive market for biological products.
In July 2018, FDA issued its Biosimilars Action Plan (see https://www.fda.gov/media/114574/download), which focuses on four areas of FDA
activities: (1) Improving the efficiency of the biosimilar and
interchangeable product development and approval process; (2)
maximizing scientific and regulatory clarity for the biosimilar product
development community; (3) developing effective communications to
improve understanding of biosimilars among patients, clinicians, and
payors; and (4) supporting market competition by reducing gaming of FDA
requirements or other attempts to unfairly delay competition. This
joint FDA and FTC workshop furthers the activities set forth in the
Biosimilars Action Plan.

II. Topics for Discussion at the Public Workshop

    FDA and FTC are holding this public workshop to engage with
stakeholders about certain aspects of a competitive market for
biological products,

including biosimilars and interchangeable products, and to discuss the
important impact these products have on public health. This includes:
     U.S. Biosimilar Markets and FDA Approval Process;
     Enforcement Activities by FDA and FTC;
     The Benefits of Competition; and
     Improving Stakeholder Engagement: Education and Access.
    FDA and FTC also encourage comments from stakeholders and the
public relating to steps FDA and FTC can take to facilitate a
competitive market for biological products.

III. Participating in the Public Workshop

    The FDA Conference Center at the White Oak location is a Federal
facility with security procedures and limited seating. Attendance will
be free and on a first-come, first-served basis. An agenda for the
workshop and any other background materials will be made available 5
days before the workshop at https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-fdaftc-workshop-competitive-marketplace-biosimilars-03092020-03092020. If you need special accommodations
because of a disability, please contact Sandra Benton (see FOR FURTHER
INFORMATION CONTACT) at least 7 days before the workshop.
    Registration and Requests for Open Public Workshop Speaker Slots.
For those interested in participating as an Open Public Workshop
speaker, please register at https://www.eventbrite.com/e/86931096249 as
``In-person Open Public Workshop presenter.'' Open Public Workshop
registrations are due by February 24, 2020; however, if time is
available, you may sign up as an Open Public Workshop speaker the day
of the meeting. Time and space are limited and available on a first-
come, first-served basis. Open Public Workshop speakers may be assigned
no more than 5 minutes for their presentation and will deliver oral
testimony only (no accompanying slide deck).
    We will do our best to accommodate requests to make public
comments. Individuals and organizations with common interests are urged
to consolidate or coordinate their presentations and request time for a
joint presentation. All requests to make oral presentations must be
received by February 24, 2020. No commercial or promotional material
will be permitted to be presented or distributed at the public
workshop.
    In-Person Attendance: For those who would like to attend in person,
but who are not participating in the Open Public Workshop, please
register at https://www.eventbrite.com/e/86931096249 as ``In-person
attendee--no participation.'' You may choose not to register; however,
seating is limited, and space will be available on a first-come, first-
served basis.
    Persons attending FDA's workshops are advised that FDA is not
responsible for providing access to electrical outlets.
    Streaming Webcast of the Public Workshop: For those unable to
attend in person, FDA will provide a live webcast of the workshop. To
join the workshop via the webcast, please go to https://www.fda.gov/drugs/news-events-human-drugs/public-workshop-fdaftc-workshop-competitive-marketplace-biosimilars-03092020-03092020 for the webcast
address. Please register at https://www.eventbrite.com/e/86931096249 as
``online (webcast only).''
    Media: Please register at https://www.eventbrite.com/e/86931096249
as ``Media'' by March 4, 2020.
    Transcripts: Please be advised that when a transcript of the public
workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES).

    Dated: January 29, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-02101 Filed 2-3-20; 8:45 am]
 BILLING CODE 4164-01-P