April 17, 2003 Supporting Statement for a Request for OMB Review under the Paperwork Reduction Act 1 IDENTIFICATION OF THE INFORMATION COLLECTION 1( a) Title: Reporting and Recordkeeping Requirements under EPA's Hospitals for a Healthy Environment ( H2E) Program EPA ICR No. 2088.01; OMB Control No. 2070 TBD 1( b) Short Characterization The Hospitals for a Healthy Environment ( H2E) Program is an Environmental Protection Agency ( EPA) voluntary program that helps hospitals enhance work place safety, reduce waste and waste disposal costs, and become better environmental stewards and neighbors. The Program is an outcome of a partnership between the American Hospital Association ( AHA) and EPA. More specifically, the Program is based on a 1998 memorandum of understanding ( MOU) ( Attachment A) signed by AHA and EPA to provide health care professionals the tools and information necessary to reduce mercury waste, reduce the overall volume of waste, and identify pollution prevention opportunities. Within EPA, the Program was developed and is managed by EPA's Office of Pollution Prevention and Toxics ( OPPT), Pollution Prevention Division.

Since its inception, the H2E Program has received high level recognition in the Administration for the importance of the work, as well as from industry for its vital role in providing important technical resources to the health care sector. H2E was the recipient of a Hammer Award in 1999, and has received several EPA awards subsequently. The health care industry has shown its enthusiasm through the numerous letters of support ( Attachment B), as well as through the level of participation in H2E to date.

Health care institutions stand to gain a great deal through participation in the H2E Program, including:

 useful technical information that will assist them in reducing cost of waste disposal;  reducing waste burden; and  gaining public recognition.

The ICR is an important component of this program, and a timely review of this application will help ensure the H2E Program's sustained success.

The H2E Program is divided into two sub programs, the Partners for Change Program and the Champions for Change Program. The Partners for Change Program recognizes health care facilities that pledge support to the H2E mission and develop goals for reducing waste and mercury in their own facilities. The Champions for Change Program recognizes organizations that encourage and aid health care facilities to participate as H2E Partners, provide on going promotional or technical assistance information, or make changes that support the goals of the H2E Program in their own institutions. An organization's decision to participate in the H2E Program is completely voluntary. Participation begins with the completion of and submittal to Page 2 EPA of either a Partner Registration and Pledge Form or a Champion for Change Application form that provides EPA with general organizational information [ see Attachment D and Attachment F, respectively]. A senior administrator or official that has authority to commit his/ her organization to the Program signs the forms. Once an organization joins the Partners for Change Program, it completes and submits to EPA an Annual Facility Assessment Summary and Goals Form [ see Attachment E]. Organizations have broad flexibility in designing their facility environmental goals. Partners and Champions may also apply for various H2E awards by submitting an Awards Application Form [ see Attachment G].

EPA expects new Partners to spend time up front in establishing a solid foundation for H2E initiatives by documenting their environmental baseline when they first join H2E and by setting their own facility performance goals, and allots six months for Partners to establish their goals. During the first year and in all subsequent years, a Partner will submit the Annual Facility Assessment Summary and Goals Form. This form is designed to help a facility establish its own environmental baseline, continue to track its own environmental progress, provide basic contact and facility information, waste and mercury assessment summaries, environmental policy information, and a description of its pollution prevention ( P2)/ waste reduction goals and activities. EPA expects organizations to implement their H2E programs and report on their progress by January 31 of each subsequent year after joining, unless less than nine months have passed since the initial submittal. The Annual Facility Assessment Summary and Goals Form is the main way Partners for Change report their environmental progress to EPA.

EPA collects the information in hard copy form or through an online registration and reporting system and then enters and stores it in a database. The information collection under the H2E Program is necessary to allow EPA to:

° Gauge progress of individual facilities participating in the Program, as well as the overall success of the Program; ° Recognize Partner accomplishments; ° Identify effective P2/ waste reduction strategies to share with others; ° Identify areas where additional technical assistance or information would be useful for individual Partners or more generally for Program participants; ° Measure environmental outcomes of actions taken by facilities; ° Recognize participants with significant P2/ waste reduction accomplishments at annual national recognition ceremonies; ° Aggregate and analyze the data in order to monitor progress towards meeting of the EPA/ AHA agreement; and ° Evaluate opportunities for improving the H2E Program.

Recognizing Partner achievements is important to help EPA spur other Partners on to reduce more waste. Sharing effective P2/ waste reduction strategies with others is a fundamental objective of the H2E Program.

The H2E Partners for Change Program currently has 273 Partners. EPA expects Program membership to increase by 500 Partners for each year of this ICR. During the first year of participation in the Program, the information collection activities will cost each Partner approximately $ 918 if they choose to submit an award application, and $ 238 if they do not. For each subsequent year, the information collection activities will cost each Partner approximately Page 3 $ 740 if they choose to submit an award application, and $ 60 if they do not. The Agency does, however, expect many organizations to recognize substantial cost savings through the implementation of their P2/ waste reduction initiatives.

The H2E Champions for Change Program currently has 30 Champions. EPA expects Program membership to increase by 50 Champions during each year of this ICR. During the first year of participation in the Program, the information collection activities will cost each Champion approximately $ 772 if they choose to submit an award application, and $ 92 if they do not. For each subsequent year, the information collection activities will cost each Champion approximately $ 698 if they choose to submit an award application, and $ 18 if they do not.

2. NEED FOR AND USE OF THE COLLECTION 2( a) Need/ Authority for the Collection Section 6604( b)( 5) of the Pollution Prevention Act ( PPA), 42 U. S. C. 13103( b)( 5) [ see Attachment C], directs EPA to facilitate the adoption of source reduction techniques by businesses, including the distribution of source reduction information to businesses. On June 24, 1998, the American Hospital Association ( AHA) and EPA signed a landmark memorandum of understanding ( MOU) identifying goals to reduce the impact of health care facilities on the environment [ see Attachment A]. The Parties to the MOU affirmed the Congressional goals and principles set forth in the PPA, 42 U. S. C. 13101 through 13109, particularly the goal of reducing the generation of pollution at its source, preferentially to the recycling, treatment, and/ or disposal of such waste. More specifically, the MOU identifies goals of the virtual elimination of mercury; reduction of persistent, bioaccumulative, and toxic ( PBT) chemicals; and a thirty three percent reduction of total waste in all hospitals by 2005 and a fifty percent reduction by 2010.

In conjunction with the American Nurses Association and Healthcare Without Harm, AHA and EPA implemented the MOU by developing the H2E Partners for Change and Champions for Change Programs. The H2E Programs' information collection activities will assist the Agency in meeting the goals of the PPA and the MOU by facilitating the education of health care professionals about P2/ waste reduction opportunities and the distribution of necessary source reduction tools and information. More specifically, EPA needs to collect initial information in the Partner Registration and Pledge Form to formally establish participation in the H2E Partners for Change Program, obtain general information on new H2E Partners, and obtain a pledge of commitment to H2E's goals. EPA needs to collect the information in the Annual Facility Assessment Summary and Goals Form in order to establish an environmental baseline for each facility, measure each participant's efforts and progress over time, gauge overall Program progress in preventing pollution and reducing waste, and identify effective P2/ waste reduction strategies for other participants in the Program.

For the H2E Champions for Change Program, EPA needs to collect initial information in the Champion for Change Application form to establish participation in the Champion Program, obtain general contact information, and identify the activities each Champion will conduct to achieve the Program's goals.

Both Partners and Champions may apply for various annual or one time H2E awards. In Page 4 order to evaluate the award candidates, EPA needs to collect information in the Awards Application Form about specific activities related to the award category.

2( b) Practical Utility/ Users of the Data The information collected by the H2E Program is not designed or intended to support regulatory decision making by EPA. EPA uses the information collected in the Partner Registration and Pledge Form to: ( 1) update its database containing information on H2E participants; ( 2) initiate contact with the primary person in charge of the Partner's H2E initiatives; and ( 3) prepare a list of H2E Partners. The information in the database is used to track organization status and prepare reports and mailing lists.

EPA uses the information collected in the Annual Facility Assessment Summary and Goals Form to: ( 1) establish an environmental baseline for each Partner; ( 2) record the Partner's activities and progress in the database; ( 3) identify effective P2 practices to develop and disseminate as case studies and other materials or recommend to Partners seeking effective P2 goals; ( 4) identify areas where additional technical assistance or information would be useful for individual Partners or more generally for Program participants, e. g., low mercury elimination figures may indicate a need for increased education about alternatives to mercury containing devices; ( 5) recognize participants with significant P2 accomplishments at annual national recognition ceremonies; ( 6) aggregate and analyze the data in order to prepare and measure progress toward the goals of the MOU; and ( 7) evaluate opportunities for improving the H2E Program.

EPA uses the general information collected in the Champion for Change Application form to: ( 1) update its database containing information on H2E participants; ( 2) initiate contact with the primary person in charge of the Champion's H2E initiatives; and ( 3) prepare a list of H2E Champions. The information in the database is used to track organization status and prepare reports and mailing lists. EPA uses the information on the activities Champions are conducting to ( 1) record the Champion's activities in the database; and ( 2) identify areas where additional technical assistance or information would be useful for individual Champions or more generally for Program participants.

EPA uses the information collected in the Awards Application Form to evaluate the achievements award candidates have made in specific areas.

3. NON DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA 3( a) Non Duplication EPA is ensuring that respondents are not requested to provide information that has been collected by EPA or any other Federal agency. Several health care related organizations are members of EPA's WasteWise Program, which collects waste reduction data from all types of businesses and organizations, and EPA's Energy Star ® energy efficiency program. EPA coordinates H2E with these programs to ensure non duplication of information collection. Page 5 Some states and regions have implemented programs that address P2 activities at hospitals and health care facilities or allow for the collection of P2 information as part of a broader collection of environmental performance information. In some cases, these programs were incorporated into, or are based on and directly linked to the H2E Program. For example, Ohio EPA signed the Ohio Healthy Hospitals Pollution Prevention Initiative with the Ohio Hospital Association, based on the federal MOU signed by EPA and AHA. Other examples include the EPA Region 1 Mercury Challenge and Health Care Without Harm/ National Wildlife Federation's Making Medicine Mercury Free Program. In these cases, the programs are either incorporated within or fully coordinated with the national H2E Program to ensure non duplication of information collection. A few other state programs have been implemented and continue to be administered separately from H2E. One example is the Sustainable Hospitals Project ( SHP), which is a partnership program that includes Massachusetts state agencies. EPA is identifying and working with these programs to ensure non duplication of information collection.

Where appropriate, EPA will accept other programs' reporting forms in lieu of the H2E Annual Facility Assessment Summary and Goals Form.

3( b) Public Notice Required Prior to ICR Submission to OMB In proposing to renew this ICR, EPA provided a 60 day public notice and comment period that ended on October 18, 2002 ( 67 FR 53789, August 19, 2002). EPA received comments from the New Hampshire Hospital Association; Columbia St. Mary's Hospital, Milwaukee, WI; Mills Peninsula Health Services, San Mateo, CA; Center for Environmental Health, Oakland, CA; the City of Albuquerque ( NM)/ Public Works Dept.; the American Nurses Association and Minnesota Technical Assistance Program. Since all of the comments were supportive, EPA did not modify the ICR that was made available for public comment. Copies of the comments are included as Attachment H.

3( c) Consultations EPA has received significant feedback on the H2E Program from key stakeholders. In completing the MOU and implementing the H2E Program, EPA worked, and continues to work, closely with AHA, which consists primarily of health care provider organizations across the United States. The H2E Program has also involved the efforts of representative of several stakeholder groups including the American Nurses Association, Health Care Without Harm, state and local government agencies, state and metropolitan health care associations, health care environmental services professionals, health care materials managers, physicians, nurses, waste management industry representatives, and product manufacturers.

The H2E effort is built upon the collaborative working relationship of this network of Partners and their commitment to the goals of mercury elimination and waste volume and toxicity reduction in hospitals. Prior to the implementation of the H2E Partners for Change and Champions for Change Programs, efforts focused on forming the Environmental Leadership Council ( ELC), which consists of representatives from the stakeholder groups listed above and serves as the oversight body for the project. The ELC established 12 working groups to develop information products and guide the development of the H2E Program. ELC representatives and other stakeholders provided guidance and feedback on the content of the program forms and the corresponding burden hour estimates. ELC members and other stakeholders generally agreed with the content and burden hour estimates for the program forms. EPA also posted draft versions of Page 6 the forms on the H2E Web site ( www. h2e online. org) and solicited comments, but no comments were received.

By gaining an understanding of current health care providers' practices and barriers to environmental programs, EPA was able to structure the H2E Program to best suit participant needs and minimize the information collection burden. EPA also worked with staff from other EPA voluntary programs, including WasteWise and ENERGY STAR ® , to gain insights into program structure and simplified reporting requirements.

Specific individuals consulted include:

Rebecca Maron 312 422 3773 American Hospital Association Laura Brannen 603 795 4040 Healthcare Without Harm Marian Condon 202 651 7134 American Nurses Association Lynn Garske 818 352 3093 Kaiser Permanente, California Pierre Gonyon 734 712 3315 McPherson Hospital, Michigan Dan Stickles 616 363 0941 St. Mary's Mercy Medical Center, Michigan Elaine Bauer 610 355 2025 Catholic Health East Jean Livingston 847 704 7463 Consortia Catherine Zimmer 612 624 4635 Minnesota Technical Assistance Program Attachment B includes letters of support from stakeholders. EPA and AHA received these letters in 2001 when AHA was reassessing its role in the Program.

In addition, during the period of public comment on this ICR, the following individuals commented upon the ICR in a supportive way:

Barbara Blakeney 202 651 7000 American Nurses Association Debbie Augustine 603 225 0900 New Hampshire Hospital Association Robert H. Hogrefe 505 873 7030 City of Albuquerque, New Mexico Ellis J. Hooker 414 291 1768 Columbia St. Mary's Hospital, Wisconsin Mamta Khanna 510 594 9864 Center for Environmental Health, California Gail D. Lee 650 696 5706 Mills Peninsula Health Services, California Catherine Zimmer 612 624 4635 Minnesota Technical Assistance Program 3( d) Effects of Less Frequent Collection The Partner Registration and Pledge Form and Champion for Change Application form are one time information submissions for organizations that wish to participate in the H2E Partners for Change or Champions for Change Programs, and therefore could not be conducted less frequently. Partners submit the Annual Facility Assessment Summary and Goals Form on an annual basis. Requiring this report on a less frequent basis would hinder EPA efforts to generate relevant and timely case studies and success stories that would be helpful to participants. Partners and Champions may choose to apply for annual and one time awards by submitting the Page 7 Awards Application Form. Requiring this information on a less frequent basis would hinder EPA efforts to recognize outstanding achievements and progress in the annual H2E awards ceremonies. Less requent data collection would hinder EPA's ability to gauge progress by individual organizations and the Program as a whole and to gain the information necessary to publicly recognize exemplary Partner waste reduction activities. Most importantly, less frequent data collection would severely hinder EPA's ability to measure the Program's success as it relates to the goals outlined in the MOU.

3( e) General Guidelines All of the collection activities described within this ICR adhere to OMB's General Guidelines.

3( f) Confidentiality No information collected by EPA under the H2E Program comprises confidential business information.

3( g) Sensitive Questions No questions of a sensitive nature are asked in any of the reporting forms.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED 4( a) Respondents and NAICS Codes The H2E Partners for Change Program targets establishments primarily engaged in furnishing medical, surgical, and other health services to individuals. Establishments of associations or groups, such as Health Maintenance Organizations ( HMOs), primarily engaged in providing medical or other health services to members are targeted as Partners, but those which limit their services to the provision of insurance against hospitalization or medical costs participate as Champions. Individual organizations may participate in the Program as Partners and Champions.

While EPA focuses its H2E Partner marketing efforts on hospitals and other health care provider organizations, the Program is open to all companies, organizations, schools, colleges, universities, and federal, state, and local governments that are able to implement activities that support the Program's goals. The following is a list of North American Industry Classification System ( NAICS) codes and associated industries that are most likely to be affected by information collection requirements covered under this ICR:

NAICS Codes Affected Industry 6211 Offices of Physicians 6212 Offices of Dentists 6213 Offices of Other Health Practitioners 6214 Outpatient Care Centers 6215 Medical and Diagnostic Laboratories Page 8 339116 Dental Laboratories 6216 Home Health Care Services 6219 Other Ambulatory Health Care Services 6221 General Medical and Surgical Hospitals 6222 Psychiatric and Substance Abuse Hospitals 6223 Specialty ( except Psychiatric and Substance Abuse) Hospitals 6231 Nursing Care Facilities 6232 Residential Mental Retardation, Mental Health, and Substance Abuse Facilities 6233 Community Care Facilities for the Elderly 6239 Other Residential Care Facilities The H2E Champions for Change Program targets a range of health care related organizations for recruitment as Champions, including health systems, health care related professional associations, Group Purchasing Organizations ( GPOs), member based organizations that champion the H2E Partners for Change Program to their members ( e. g., environmental groups, grassroots organizations), vendors, manufacturers, consultants, and other service providers. Although these organizations can fall under a wide range of industry sectors, most will come from the codes listed above for Partners, or from the following NAICS codes:

NAICS Codes Associated Industry 8132 Grantmaking and Giving Services 8133 Social Advocacy Organizations 8134 Civic and Social Organizations 8139 Business, Professional, Labor, Political and Similar Organizations 4( b) Information Requested Once a prospective organization reviews the H2E Partners For Change materials and decides to join the Program, it submits a Partner Registration and Pledge Form ( Attachment D). By January 31 of each year, Partners that joined the Program by August 31 of the preceding year report on the progress made toward achieving their goals on the Annual Facility Assessment Summary and Goals Form ( Attachment E). Organizations that join the H2E Champions for Change Program need only submit the Champion for Change Application form ( Attachment F) at the time they join. Partners and Champions that wish to apply for awards are required to submit the Awards Application Form ( Attachment G) by March 1.

All of the forms are available in hard copy or electronic form. Participants can use the hard copy forms they receive from EPA by mail or download PDF versions of the forms from the H2E Web site. Participants will also be able to use the online registration and reporting system ( planned for 2004).

Partner Registration and Pledge Form H2E Partners for Change Program participants complete and submit to EPA a standard, onepage Partner Registration and Pledge Form that provides basic organization information.

( i) Data items: Page 9 The reporting items include:

° Facility name and Web site URL; ° Name, title, address, phone number, fax number, and e mail address of the Partner's primary contact person; ° Description of facility and any relevant affiliations; ° Signature, name, and title of senior administrator and the date signed.

° OPTIONAL: The Partner may provide additional information describing the organization's previous waste reduction efforts under other programs and previous waste assessment efforts.

( ii) Respondent activities:

Participants conduct the following activities in order to complete and submit the Partner Registration and Pledge Form:

° Review the H2E Partners for Change Program information and overall H2E Program information; ° Decide whether to join the Program; ° Select a primary contact person for the Program; ° Complete the Partner Registration and Pledge Form, including obtaining the signature of a senior administrator; and ° Fax or mail the form to EPA or submit the form through the online registration system.

Annual Facility Assessment Summary and Goals Form H2E Partners for Change participants complete and submit to EPA a standard, two page Annual Facility Assessment Summary and Goals Form that describes the Partner's P2/ waste reduction goals and progress. This form is due within six months of joining H2E ( for new Partners) and by January 31 of each subsequent year, unless less than nine months have passed since submittal of the initial form.

( i) Data items:

The reporting items include:

° Section 1: Contact Information.

 Facility/ System name;  Name, title, address, phone number, fax number, and e mail address of the Partner's primary contact person; and  Year for which the information is being requested.

° Section 2: Facility Information. The Partner completes the following data items depending on which facility type( s) are applicable: Page 10  If " In Patient/ Hospital" facility: number of adjusted patient days, number of beds, and number of staff;  If " Ambulatory Care/ Outpatient Clinics" facility: number of outpatient visits and number of staff;  If " General Administrative" facility: number of staff; and  If " Long Term Care" facility: number of beds and number of staff.

° Section 3: Facility Waste Assessment Summary.

 Tons of solid waste generated per year, amount of solid waste as percent of total waste, and annual cost of solid waste management;  Tons of waste recycled/ reused per year, amount of waste recycled/ reused as percent of total waste, and annual cost of recycling/ reuse activities;  Tons of regulated medical waste generated per year, amount of regulated medical waste as percent of total waste, and annual cost of regulated medical waste management;  Tons of hazardous waste generated per year, amount of hazardous waste as percent of total waste, and annual cost of hazardous waste management; and  Total tons of waste per year from all categories and annual cost of all waste management activities.

° Section 4: Mercury Assessment. Partners answer " yes" or " no" to four mercuryrelated questions:

 " Is your facility virtually mercury free?"  " Has your facility conducted a facility inventory of mercury containing devices and chemicals?"  " Has your facility implemented a mercury purchasing policy?"  " Has your facility eliminated mercury containing patient care devices?" and  OPTIONAL: The Partner may provide a description of mercury elimination efforts to date.

° Section 5: Environmental Policies. Partners indicate whether or not they have implemented each of the following by checking either the " yes" or " no" box: a facility environmental commitment statement, a comprehensive waste management policy, a mercury management/ elimination policy, and an environmentally preferable purchasing policy.

° Section 6: H2E Goals. Partners are asked to list their H2E goals and describe source reduction, mercury elimination, recycling, reuse, and donation activities they will implement to achieve each goal.

 The H2E goals the Partner plans to undertake and the source reduction, mercury elimination, recycling, reuse, and donation activities the Partner will implement to achieve each goal.

EPA assumes that participating organizations keep facility information, waste assessment, and policy data as a Common Business Practice. The other data items do not require any record Page 11 keeping activities, and therefore, burden associated with recordkeeping is not included in this ICR.

( ii) Respondent activities:

Participants conduct the following activities in order to complete and submit the Annual Facility Assessment Summary and Goals Form:

° Review the information contained in the H2E Self Assessment Guide ( available on the H2E Web site), which describes how to conduct baseline waste assessments and identify P2 opportunities; ° Conduct at least a cursory review of materials used or disposed of by the organization ( level of detail and effort will vary among organizations and may include establishing a P2/ waste reduction team) to determine cost effective H2E goals; ° Set up a measurement/ tracking system for P2/ waste reduction activities, if such a system is not already established ( level of detail and effort will vary among organizations); ° Collect and review records to assess progress during the reporting year; ° Complete the Annual Facility Assessment Summary and Goals Form; ° Fax or mail the form to EPA or submit the form through the online reporting system; and ° Respond to EPA questions to clarify data and/ or goals.

Champion for Change Application form Champions complete and submit to EPA a standard, one page Champion for Change Application form that provides basic association information and describes recruitment and promotional activities.

( i) Data items:

The reporting items include:

° Organization name and Web site URL; ° Name, title, address, phone number, fax number, and e mail address of the Champion's principal contact person; ° Approximate number of health care facilities associated with the organization; ° Type of organization; ° Statement of current compliance with pertinent regulations; ° Expression of commitment to waste reduction and pollution prevention activities ° Descriptions of objectives and implementation strategies to effect waste reduction and pollution prevention efforts; and ° Signature, name, and title of senior official and the date signed.

( ii) Respondent activities: Page 12 Champions conduct the following activities in order to complete and submit the Champion for Change Application form:

° Review the H2E Champions for Change Program information and overall H2E Program information; ° Select a primary contact person for the Champion H2E Program; ° Complete the Champion for Change Application form, including obtaining the signature of a senior official; ° Plan and implement P2/ waste reduction activities, and recruit other facilities to adopt similar activities; and ° Fax or mail the form to EPA or submit the form through the online registration system.

Awards Application Form H2E Partners for Change and Champions for Change Program participants may choose to complete and submit to EPA a standard, one page Awards Application Form that provides basic organization information and designation of the award for which the organization is applying. In addition, award applicants are required to describe how their organization has met the evaluation criteria for the award.

( i) Data items:

The reporting items include:

° Date and facility name; ° Name, title, department, address, phone number, fax number, and e mail address of the organization's primary contact person; ° Indication of whether or not the organization has received recognition ( other than from the H2E Program) for its environmental initiatives; ° Award for which the application is being submitted; ° Checklist of actions and materials required to complete award application packet; ° Signature and printed name of contact person.

( ii) Respondent activities:

Participants conduct the following activities in order to complete and submit the Awards Application Form:

° Select one of the following awards categories: H2E Partner Recognition, Making Medicine Mercury Free Award, H2E Partners for Change Award, H2E Environmental Leadership Award, H2E Champion Award; ° Complete the Awards Application Form; ° Describe how their organization meets the evaluation criteria for the award and submit checklist if applicable; ° Submit supporting material such as photographs, newsletters, fliers, and policies; ° Fax or mail the form and supporting materials to EPA. Page 13 5. THE INFORMATION COLLECTED   AGENCY ACTIVITIES, COLLECTION METHODOLOGY, AND INFORMATION MANAGEMENT 5( a) Agency Activities Under the H2E Program, EPA engages in the following activities related to the four reporting forms:

Partner Registration and Pledge Form ° Distribute the Partner Registration and Pledge Form to potential participants, maintain a downloadable PDF version on the H2E Web site, and make it available as part of an online registration system; ° Answer questions posed by potential participants regarding membership in the Program; and ° Receive completed forms, enter information into a database, conduct quality assurance/ quality control ( QA/ QC) on data entry, and place a welcome call to the new Partner.

Annual Facility Assessment Summary and Goals Form ° Distribute the Annual Facility Assessment Summary and Goals Form to program Partners, maintain a downloadable PDF version on the H2E Web site, and make it available as part of an online reporting system; ° Maintain a tracking system and develop/ revise standard data reports; ° Answer questions regarding the Annual Facility Assessment Summary and Goals Form; ° Share information with interested Partners on possible goals for their organization; ° Receive the completed forms, review for accuracy, and place any necessary followup calls; ° Enter information into a database and conduct QA/ QC on data entry; and ° Develop and make publicly available an annual summary of overall program progress and case studies of highly successful programs.

Champion for Change Application form ° Distribute the Champion for Change Application form to program Partners, maintain a downloadable PDF version on the H2E Web site, and make it available as part of an online registration system;

° Answer questions posed by potential Champions regarding membership in the Program; ° Receive completed forms, enter information into a database, conduct QA/ QC on data entry, and place a welcome call to the new Champion.

Awards Application Form ° Distribute the Awards Application Form to program participants when requested Page 14 and maintain a downloadable PDF version on the H2E Web site; ° Answer questions posed by potential award applicants regarding the awards and award application process; ° Receive completed forms and supporting materials and make award selections; and ° Notify both successful and unsuccessful applicants of the award decisions.

5( b) Collection Methodology and Management Respondents will be able to obtain the reporting forms in hard copy from EPA or by downloading them from the H2E Web site. The completed forms can be faxed or mailed to EPA, or submitted through the online registration system that is planned for 2004.

In collecting and analyzing the information associated with this ICR, EPA uses a telephone system, personal computers, an online registration and reporting system, and applicable database software. EPA ensures the accuracy and completeness of collected information by reviewing each submittal. EPA enters the information obtained from the forms into a database and conducts QA/ QC on data entry. The Agency uses software to aggregate data obtained from Annual Facility Assessment Summary and Goals Forms. The aggregate data is used to identify prominent P2/ waste reduction strategies, and to develop and publish an annual summary of overall Partner progress and case studies of highly successful P2/ waste reduction activities.

5( c) Small Entity Flexibility EPA expects that some of the participants in the H2E Program will be small entities. EPA has designed its reporting forms to minimize respondent burden while obtaining sufficient and accurate information. Reporting will be further facilitated by the creation of an online registration and reporting system, which is planned for 2004. The H2E Program was designed to be highly flexible. Organizations can choose their own goals based on individual organization needs and resources. In addition, the burden associated with the H2E Program is inherently reduced since the initial agreement to participate is voluntary.

5( d) Collection Schedule Organizations may submit Partner Registration and Pledge Forms to join the H2E Partners for Change Program at any time. Within six months after a participant joins the Program, it should submit the Annual Facility Assessment Summary and Goals Forms. Annual Facility Assessment Summary and Goals Forms are also due to EPA by January 31 of every subsequent year that the Partner participates in the Program, unless less than nine months have passed since submittal of the initial form. Organizations may submit Champion for Change Application forms to join the H2E Champions for Change Program at any time. Partners and Champions may choose to apply for awards by submitting the Awards Application Form; award applications are due January 1 of each year.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION 6( a) Estimating Respondent Burden Page 15 Exhibit 6.1 presents the burden hours and costs for all respondents during each of the three years covered under this ICR.

The Partner Registration and Pledge Form contains basic questions and only applies for the first year, thus the burden is expected to be minimal. The overall burden is estimated to be 1.7 hours per participant. This burden level is an estimate based on EPA's experience with other voluntary programs and based on the advice of H2E partnering organizations. Burden hours for the Partner Registration and Pledge Form are for reporting only.

Completing the Annual Facility Assessment Summary and Goals Form involves assessing hospital waste and developing goals and a system to track progress. The annual labor burden for this collection activity is estimated at 5.25 hours per participant the first year and 1.75 hours per participant in subsequent years. Burden hours for the Annual Facility Assessment Summary and Goals Form are largely for reporting activities, since the recordkeeping activities are considered to be customary business practices.

The Champion for Change Application form asks for basic information and requests brief/ general descriptions of promotional activities, thus the burden is expected to be minimal. The overall burden, as shown in Exhibit 6.1, is estimated to be 2.7 hours per participant. This burden level is based on EPA experience with similar voluntary programs and based on the advice of H2E partnering organizations. All burden hours for the Champion for Change Application form are for reporting only. In addition to answering basic questions similar to those listed on the Partner registration and pledge form, the H2E Champions are requested to describe their plans for and implementation of P2/ waste reduction activities, and their plans to recruit other facilities to adopt similar activities. After the first year, Champions will be asked to provide an informal update each year ( no form required) regarding the ways in which they promote the H2E Program on a continued basis. EPA estimates that the burden of this update will be 0.5 hours per Champion per year.

EPA estimates that 25 percent of Partners and Champions will apply for awards each year. The overall burden required to prepare supporting application materials and to complete the Awards Application Form is estimated to be 20 hours per applicant.

6( b) Estimating Respondent Costs EPA estimates an average hourly labor rate ( hourly rate plus overhead) of $ 60 for managerial staff, $ 35 for technical staff, and $ 20 for clerical staff. The hourly labor rates were provided by the Dartmouth Hitchcock Medical Center in Lebanon, New Hampshire, and reflect national averages. It is presumed that technical staff will complete 80 percent of the tasks listed in Exhibit 6.1, clerical staff will complete 15 percent, and managerial staff will complete 5 percent.

No capital or operations and management costs are incurred by respondents under this ICR.

Exhibit 6.1. Estimated Annual Burden and Costs to Respondents Page 16 Collection Activity Estimated # of Responses Estimated response time in hours TOTAL BURDEN TOTAL COST M ( 5%) T ( 80%) C ( 15%) Total Hours Partner Registration Form 500 Review Program information .5 12.5 200 37.5 250 $ 8,500 Obtain senior approval 1 25 400 75 500 17,000 Complete and submit form .2 5 80 15 100 3,400 Subtotal 500 1.7 42.5 680 127.5 850 $ 28,900 Annual Facility Assessment Summary and Goals Form ( First Year) 500 Review H2E Assessment Guide .5 12.5 200 37.5 250 $ 8,500 Collect data/ review records 4 100 1,600 300 2,000 68,000 Complete form .25 6.25 100 18.75 125 4,250 Fax/ mail form to EPA .25 6.25 100 18.75 125 4,250 Respond to EPA questions .25 6.25 100 18.75 125 4,250 Subtotal 500 5.25 131.25 2,100 393.75 2,625 $ 89,250 Annual Facility Assessment Summary and Goals Form ( Subsequent Years) 500 Review previous goals and set new goals .5 12.5 200 37.5 250 $ 8,500 Collect data .5 12.5 200 37.5 250 8,500 Complete form .25 6.25 100 18.75 125 4,250 Fax/ mail form to EPA .25 6.25 100 18.75 125 4,250 Respond to EPA questions .25 6.25 100 18.75 125 4,250 Subtotal 500 1.75 43.75 700 131.25 875 $ 29,750 Champion Application Form 50 Review Program information .5 1.25 20 3.75 25 $ 850 Obtain senior approval 1 2.5 40 7.5 50 1,700 Identify activities 1 2.5 40 7.5 50 1,700 Complete and submit form .2 .5 8 1.5 10 340 Subtotal 50 2.7 6.75 108 20.25 135 $ 4,590 Awards Application Form 140 Select award category .5 3.5 56 10.5 70 $ 2,380 Complete Form .25 1.75 28 5.25 35 1,190 Describe how organization meets evaluation criteria 18 126 2,016 378 2,520 85,680 Submit supporting materials 1 7 112 21 140 4,760 Fax/ mail form to EPA .25 1.75 28 5.25 35 1,190 Subtotal 140 20 140 2,240 420 2,800 $ 95,200 YEAR 1 Partner Registration Form 500 1.7 42.5 680 127.5 850 $ 28,900 Annual Facility Assessment ( First Year) 500 5.25 131.25 2,100 393.75 2,625 89,250 Page 17 Collection Activity Estimated # of Responses Estimated response time in hours TOTAL BURDEN TOTAL COST M ( 5%) T ( 80%) C ( 15%) Total Hours Champion Application Form 50 2.7 6.75 108 20.25 135 4,590 Awards Application Form 140 20 140 2,240 420 2,800 95,200 TOTAL 1,190 320.5 5,128 961.5 6,410 $ 217,940 YEAR 2 Partner Registration Form 500 1.7 42.5 680 127.5 850 $ 28,900 Annual Facility Assessment ( First Year) 500 5.25 131.25 2,100 393.75 2,625 89,250 Annual Facility Assessment ( Subsequent Year) 500 1.75 43.75 700 131.25 875 29,750 Champion Application Form 50 2.7 6.75 108 20.25 135 4,590 Champion Update 50 .5 25 25 875 Awards Application Form 280 20 280 4,480 840 5,600 190,400 TOTAL 1,880 504.25 8,093 1,512.75 10,110 $ 343,765 YEAR 3 Partner Registration Form 500 1.7 42.5 680 127.5 850 $ 28,900 Annual Facility Assessment ( First Year) 500 5.25 131.25 2,100 393.75 2,625 89,250 Annual Facility Assessment ( Subsequent Year) 1,000 1.75 87.5 1,400 262.5 1,750 59,500 Champion Application Form 50 2.7 6.75 108 20.25 135 4,590 Champion Update 100 .5 50 50 1,750 Awards Application Form 420 20 420 6,720 1,260 8,400 285,600 TOTAL 2,570 688 11,058 2,064 13,810 $ 469,590 3 YEAR TOTAL 5,640 1,512.75 24,279 4,538.25 30,330 $ 1,031,295 6( c) Estimating the Respondent Universe and Total Burden and Costs Burden EPA estimates that over the three year life of the clearance, 1,500 hospitals will join the H2E Program and complete the Partner Registration and Pledge Form and Annual Facility Assessment Summary and Goals Form. In addition, 150 Champions will complete the Champion for Change Application form and updates. EPA estimates that Partners and Champions will submit approximately 840 awards applications over the three year period. The total burden hours associated with this information collection is 30,330 hours and $ 1,031,295.

6( d) Estimating Agency Burden and Costs Exhibit 6.2 presents the estimated Agency burden hours and costs associated with the information collection activities under this ICR. Other direct costs ( copying, printing, telephone, and mailing expenses) are also included. EPA based its burden estimates on its experience managing other voluntary programs.

Based on the general schedule ( GS) pay schedule, EPA estimates an average hourly labor rate ( hourly rate plus the standard government overhead factor of 1.6) of $ 54 for managerial staff, $ 39 for technical staff, and $ 18 for clerical staff. The Agency expects most activities to be Page 18 performed by managerial staff ( 25 percent) and technical staff ( 75 percent). When clerical staff is utilized, clerical activities will constitute one percent of the work ( with technical staff at 74 percent).

Exhibit 6.2. Annual Agency Burden/ Cost Activities Hours Other Direct Costs TOTAL COST Partner Pledge and Registration Form For 500 forms Distribute Forms 20 $ 100 $ 950 Answer Questions 30 $ 250 $ 1,533 Record/ Enter Forms 20 $ 100 $ 950 Mail Partner Packets 10 $ 600 $ 988 Subtotal 80 $ 1,050 $ 4,421 Annual Facility Assessment and Goals Form For 500 forms Distribute Form 20 $ 100 $ 950 Maintain Database 40 $ 100 $ 1,800 Answer Questions 30 $ 250 $ 1,533 Review Submitted Data 40 $ 100 $ 1,800 Enter/ QA Data in Database 20 $ 100 $ 950 Develop Report/ Share Information 40 $ 300 $ 2,000 Subtotal 150 $ 950 $ 9,033 Champion for Change Application Form For 50 forms Distribute Forms 3 $ 10 $ 217 Answer Questions 10 $ 150 $ 578 Record/ Enter Forms 4 $ 75 $ 246 Mail Champion Packets 4 $ 60 $ 455 Subtotal 21 $ 295 $ 1,496 Awards Application Form For 140 forms Distribute Forms 8 $ 28 $ 368 Answer Questions 20 $ 200 $ 1,050 Make Award Selections 10 $ 150 $ 575 Notify Applicants of Decision 4 $ 28 $ 198 Subtotal 42 $ 406 $ 2,191 Year 1 Total 293 $ 2,701 $ 17,141 Year 2 Total 485 $ 4,057 $ 28,365 Year 3 Total 677 $ 5,413 $ 39,589 3 Year Total 1,455 $ 12,171 $ 85,095 Page 19 6( e) Bottom Line Burden Hours and Cost Tables a. Respondent Tally Exhibit 6.3. Average Annual Estimated Respondent Burden and Cost Summary Average # of Respondents Average Annual Burden Hours Average Annual Cost 550 10,110 $ 343,765 b. Agency Tally Exhibit 6.4. Average Annual Estimated Agency Burden and Cost Summary Annual Burden Hours Annual Cost 485 $ 28,365 6( f) Reasons for Change in Burden Since this is a new ICR, change in respondent burden is not applicable.

6( g) Burden Statement The annual public burden for this collection of information is estimated to range between 0.5 and 20 hours per response, depending upon the type of information the respondent provides. According to the Paperwork Reduction Act, " burden" means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. For this collection it includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for this information collection appears above. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register, are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

To comment on the Agency's need for this information, the accuracy of the provided burden estimates, and any suggested methods for minimizing respondent burden, including the use of automated collection techniques, EPA has established a public docket for this ICR under Docket ID No. OPPT 2002 0036, which is available for public viewing at the EPA Docket Center ( EPA/ DC), EPA West, Room B102, 1301 Constitution Ave., NW, Washington, DC. The EPA Docket Center Public Reading Room is open from 8: 30 a. m. to 4: 30 p. m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is ( 202) 566 1744, and the telephone number for the Pollution Prevention and Toxics Docket is ( 202) 566 0280. An Page 20 electronic version of the public docket is available through EDOCKET at http:// www. epa. gov/ edocket. Use EDOCKET to submit or view public comments, access the index listing of the contents of the public docket, and to access those documents in the public docket that are available electronically. Once in the system, select " search," then key in the docket ID number identified above. Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, DC 20503, Attention: Desk Office for EPA. Please include the EPA Docket ID No. OPPT 2002 0036 in any correspondence.

ATTACHMENTS:

[ NOTE: Unless otherwise noted, an electronic copy of the attachment is available only as a PDF file. You can still easily access the electronic PDF file in the electronic version of the public docket available through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID number: OPPT 2002 0036. Search the docket index for this document by the title provided above. If you have any difficulties, please contact the technical person listed in the Federal Register notice announcing the submission of this ICR to OMB for review and approval.]

Attachment Document A Memorandum of Understanding Between AHA and EPA B Letters of Support C Pollution Prevention Act Section 6604( b)( 5); 42 U. S. C. 13103( b)( 5) [ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.]

D Partner Registration and Pledge Form E Annual Facility Assessment Summary and Goals Form F Champion for Change Application Form G Awards Application Form H Public Comments Received During Public Notice and Comment Period and EPA's Response to Comments [ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.]

I Paperwork Reduction Act Notice [ The electronic copy for this attachment is available as part of the electronic copy of the ICR's Supporting Statement.] ATTACHMENT A Memorandum of Understanding Between AHA and EPA ( Note: An electronic copy of this attachment is available only as a PDF file. You can easily access this file in the electronic version of the public docket available through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID number: OPPT 2002 0036. Search the docket index for this document by the title provided above. If you have any difficulties, please contact the technical person listed in the Federal Register notice announcing the submission of this ICR to OMB for review and approval.) ATTACHMENT B Letters of Support ( Note: An electronic copy of this attachment is available only as a PDF file. You can easily access this file in the electronic version of the public docket available through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID number: OPPT 2002 0036. Search the docket index for this document by the title provided above. If you have any difficulties, please contact the technical person listed in the Federal Register notice announcing the submission of this ICR to OMB for review and approval.) ATTACHMENT C Pollution Prevention Act Section 6604( b)( 5)

42 U. S. C. 13103( b)( 5)

[ Electronic copy available as part of the electronic copy of the ICR's Supporting Statement.] U. S. Code As of January 23, 2000 TITLE 42 THE PUBLIC HEALTH AND WELFARE CHAPTER 133 POLLUTION PREVENTION Sec. 6604. EPA activities * * *

b) Functions The Administrator shall develop and implement a strategy to promote source reduction. As part of the strategy, the Administrator shall   * * *

( 5) facilitate the adoption of source reduction techniques by businesses. This strategy shall include the use of the Source Reduction Clearinghouse and State matching grants provided in this chapter to foster the exchange of information regarding source reduction techniques, the dissemination of such information to businesses, and the provision of technical assistance to businesses. The strategy shall also consider the capabilities of various businesses to make use of source reduction techniques ATTACHMENT D Partner Registration and Pledge Form Please also see Attachment I  Paperwork Reduction Act Notice, for additional information that will accompany the form. Once approved by OMB, the OMB Control number assigned to this ICR will also be included in the upper right corner of the form, i. e., " Approved under OMB Control No. 2070[ insert # assigned by OMB); OMB Approval expires [ insert ICR expiration date]."

( Note: An electronic copy of this attachment is available only as a PDF file. You can easily access this file in the electronic version of the public docket available through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID number: OPPT 2002 0036. Search the docket index for this document by the title provided above. If you have any difficulties, please contact the technical person listed in the Federal Register notice announcing the submission of this ICR to OMB for review and approval.) ATTACHMENT E Annual Facility Assessment Summary and Goals Form Please also see Attachment I  Paperwork Reduction Act Notice, for additional information that will accompany the form. Once approved by OMB, the OMB Control number assigned to this ICR will also be included in the upper right corner of the form, i. e., " Approved under OMB Control No. 2070[ insert # assigned by OMB); OMB Approval expires [ insert ICR expiration date]."

( Note: An electronic copy of this attachment is available only as a PDF file. You can easily access this file in the electronic version of the public docket available through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID number: OPPT 2002 0036. Search the docket index for this document by the title provided above. If you have any difficulties, please contact the technical person listed in the Federal Register notice announcing the submission of this ICR to OMB for review and approval.) ATTACHMENT F Champion for Change Application Form Please also see Attachment I  Paperwork Reduction Act Notice, for additional information that will accompany the form. Once approved by OMB, the OMB Control number assigned to this ICR will also be included in the upper right corner of the form, i. e., " Approved under OMB Control No. 2070[ insert # assigned by OMB); OMB Approval expires [ insert ICR expiration date]."

( Note: An electronic copy of this attachment is available only as a PDF file. You can easily access this file in the electronic version of the public docket available through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID number: OPPT 2002 0036. Search the docket index for this document by the title provided above. If you have any difficulties, please contact the technical person listed in the Federal Register notice announcing the submission of this ICR to OMB for review and approval.) ATTACHMENT G Awards Application Form Please also see Attachment I  Paperwork Reduction Act Notice, for additional information that will accompany the form. Once approved by OMB, the OMB Control number assigned to this ICR will also be included in the upper right corner of the form, i. e., " Approved under OMB Control No. 2070[ insert # assigned by OMB); OMB Approval expires [ insert ICR expiration date]."

( Note: An electronic copy of this attachment is available only as a PDF file. You can easily access this file in the electronic version of the public docket available through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID number: OPPT 2002 0036. Search the docket index for this document by the title provided above. If you have any difficulties, please contact the technical person listed in the Federal Register notice announcing the submission of this ICR to OMB for review and approval.) ATTACHMENT H Public Comments Received During Public Notice and Comment Period and EPA's Response to Comments [ Electronic copy available as part of the electronic copy of the ICR's Supporting Statement.] PUBLIC COMMENTS RECEIVED DURING PUBLIC NOTICE AND COMMENT PERIOD AND EPA'S RESPONSE TO COMMENTS PART A  SUMMARY OF PUBLIC COMMENTS RECEIVED The following is a summary of the public comments submitted to EPA during the comment period for this new ICR. Although electronic copies of the original comments are not available, you may view the paper copies at the EPA Docket Center as described in the Federal Register notice announcing the submission of this ICR to OMB. You can also access location information through EDOCKET at http:// www. epa. gov/ edocket. Once in the system, select " quick search," then indicate that you'd like to search by Docket and key in the following docket ID number: OPPT 2002 0036.

Document ID No. OPPT 2002 0036 0003 Comment: The NH Association has been a H2E participant since the inception of the program and is currently a Champion for Change participant. The Association fully supports EPA request to collect information on healthcare facilities that participate in the H2E program.

Document ID No. OPPT 2002 0036 0004 Comment: Columbia St. Mary's Hospital has been a H2E participant since 2001, and is currently a Partner for Change participant. St. Mary's fully support EPA's request to collect information on healthcare facilities that participate in the H2E program.

Document ID No. OPPT 2002 0036 0005 Comment: The Mills Peninsula Health Services has been a H2E participant since 2001, and is currently a Partner for Change participant. Mills Peninsula fully supports EPA's request to collect information on healthcare facilities that participate in the H2E program.

Document ID No. OPPT 2002 0036 0006 Comment: The Center for Environmental Health has been a H2E program participant since November 2001, and is currently a Champion for Change participant. The Center fully support EPA's request to collect information on healthcare facilities that participate in the H2E program.

Document ID No. OPPT 2002 0036 0007 Comment 5: The City of Albuquerque's Public Works Department has been a H2E participant since 2001, and is currently a Champion for Change participant. The Department fully support EPA's request to collect information on healthcare facilities that participate in the H2E program.

Document ID No. OPPT 2002 0036 0008 Comment: The American Nurses Association has been a H2E program participant since 1998, and is currently one of the four partners with EPA, the American Hospital Association and Health Care Without Harm. The Association support EPA's request to collect information on healthcare facilities that participate in the H2E program.

Document ID No. OPPT 2002 0036 0009 Comment: The Minnesota Technical Assistance Program ( MnTAP) has been a H2E program participant since 1998, and is currently a Champion for Change participant. MnTAP fully support EPA's request to collect information on healthcare facilities that participate in the H2E program.

PART B  EPA'S RESPONSE TO COMMENTS All of the comments received on this ICR during the public comment period were supportive of the ICR as written. We have therefore made no substantive changes to the ICR. ATTACHMENT I Paperwork Reduction Act Notice Under 5 CFR 1320.8( c)( 1), the Agency is required to provide reasonable notice to potential respondents that informs them about the information collection activity and OMB's approval. As such, pursuant to 5 CFR 1320.8( c)( 1)( i), the following statement will be included with each form, either on the form, as part of the instructions, or in the cover letter or memorandum accompanying the form, and, pursuant to 5 CFR 1320.8( c)( 1)( ii), the following statement will be included as a pop up message that the respondent will encounter before they access the associated form( s) on line. Once the forms are approved by OMB, the OMB Control number assigned to this ICR will also be included in the upper right corner of the form, i. e., " Approved under OMB Control No. 2070[ insert # assigned by OMB); OMB Approval expires [ insert ICR expiration date]."

This statement will be modified as indicated for use with the associated form( s).

[ Electronic copy available as part of the electronic copy of the ICR's Supporting Statement.] Paperwork Reduction Act Notice:

The annual public burden for this collection of information, which is approved under OMB Control No. 2070 XXXX[# will be inserted after OMB approval and before use], is estimated to be ## hours [ Since the total ICR burden is estimated to range between 0.5 and 20 hours per response, the entry for each form will be inserted and fit within this range.] per response. This represents the average burden for completing this form, including the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information subject to approval under the PRA unless it displays a currently valid OMB control number. The OMB control number for this information collection appears above and on the forms. Comments on this information collection activity or EPA's burden estimates may be submitted EPA online at http:// www. epa. gov/ edocket ( our preferred method) or by mail to: EPA Docket Center, Environmental Protection Agency, Mailcode: 7407T, 1200 Pennsylvania Ave., NW, Washington, DC 20460. Once in the system, select " search," then key in the Docket ID No. OPPT 2002 0036. Do not submit any completed forms to the docket. Completed forms should be submitted in accordance with the instructions provided with each form.


[Federal Register Volume 77, Number 58 (Monday, March 26, 2012)]
[Rules and Regulations]
[Pages 17323-17325]
[FR Doc No: 2012-6837]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

Federal Register / Vol. 77, No. 58 / Monday, March 26, 2012 / Rules
and Regulations

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 23

[Docket No. FAA-2011-1387; Special Conditions No. 23-256-SC]

Special Conditions: XtremeAir GmbH, XA42; Acrobatic Category
Aerodynamic Stability

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final special conditions.

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

SUMMARY: These special conditions are issued for the XtremeAir GmbH
XA42 airplane. The XA42 airplane has a novel or unusual design feature
associated with its static stability. This airplane can perform at the
highest level of aerobatic competition. To be competitive, the aircraft
was designed with positive and, at some points, neutral stability
within its flight envelope. Its lateral and directional axes are also
decoupled from each other providing more precise maneuvering. The
applicable airworthiness regulations do not contain adequate or
appropriate safety standards for these design features. These special
conditions contain the additional safety standards that the
Administrator considers necessary to establish a level of safety
equivalent to that established by the existing airworthiness standards.
These special conditions are only applicable to aircraft certified
solely in the acrobatic category.

DATES: Effective Date: April 25, 2012.

FOR FURTHER INFORMATION CONTACT: Mr. Ross Schaller, Federal Aviation
Administration, Small Airplane Directorate, Aircraft Certification
Service, 901 Locust, Room 301, Kansas City, Missouri 64106; telephone
(816) 329-4162; facsimile<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background

    On May 3, 2011, XtremeAir GmbH applied for a type certificate for
their new model XA42. The XA42 is certified under EASA authority as a
dual category (acrobatic/utility) airplane. It has a two-place tandem
canopy cockpit and a single-engine. It also features a conventional
landing gear, conventional low-wing planform and is of composite
construction. The engine is a Lycoming AEIO-580-B1A with a rated power
of 315 Hp at 2,700 rpm. The airplane is proposed to be approved for
Day-VFR operations with no icing approval.
    The maximum takeoff weight is 2,200 pounds in utility category,
1,874 pounds in acrobatic category. VNE is 225 knots,
VNO is 185 knots and VA is 174 knots, indicated
airspeed. Maximum altitude is 15,000 feet.
    Acrobatic airplanes previously type certificated by the FAA did
comply with the stability provisions of Subpart B of 14 CFR part 23.
However, airplanes like the XA42 are considered as ``unlimited''
acrobatic aircraft because they can perform at the highest level of
aerobatic competition and can perform any of the maneuvers listed in
the Aresti Catalog. Generally, the evolution of the ``unlimited'' types
of acrobatic airplanes, with very low mass, exceptional roll rates and
very high G capabilities, in addition to power to mass ratios that are
unique to this type of airplane, have led to airplanes that cannot
comply with the stability provisions of the regulations. These
airplanes can still be type-certificated, but in the acrobatic category
only and with an appropriate set of special conditions and associated
limitations.
    The FAA will only consider certifying the XA42 in the acrobatic
category. XtremeAir GmbH will not be able to offer a utility category
operating envelope to accommodate the increased fuel load designed for
cross-country operations. The FAA does recognize that fuel exhaustion
is one of the top accident causes associated with this class of
aircraft. For this reason, the FAA allows XtremeAir to seek
certification of a limited acrobatic envelope at a higher weight that
will still meet the minimum load requirements of +6/-3 g associated
with 14 CFR, part 23, Sec.  23.337. The XA42 airplane would be approved
for unlimited maneuvers at or below its designed unlimited acrobatic
weight. The airplane would also be approved at some higher weight (for
fuel) that would still meet the requirements of Sec.  23.337 for
acrobatic category and may have restrictions on the maneuvers allowed.

Type Certification Basis

    Under the provisions of 14 CFR, part 21, Sec.  21.17, XtremeAir
GmbH must show that the XA42 meets the applicable provisions of part
23, as amended by Amendments 23-1 through 23-59 thereto.
    Part 36 of Title 14 of the Code of Federal Regulations, effective
December 1, 1969, as amended by Amendments 36-1 through 36-28.
    Not approved for ditching; compliance with provisions for ditching
equipment in accordance with 14 CFR 23.1415(a)(b) has not been
demonstrated.
    Approved for VFR-day only. Flight in known icing prohibited.
    If the Administrator finds that the applicable airworthiness
regulations (i.e., 14 CFR part 23) do not contain adequate or
appropriate safety standards for the XA42 because of a novel or unusual
design feature, special conditions are prescribed under the provisions
of Sec.  21.16.
    In addition to the applicable airworthiness regulations and special
conditions, the XA42 must comply with the fuel vent and exhaust
emission requirements of 14 CFR part 34 and the noise certification
requirements of 14 CFR part 36 and the FAA must issue a finding of
regulatory adequacy pursuant to section 611 of Public Law 92-574, the
``Noise Control Act of 1972.''
    Special conditions, as defined in Sec.  11.19, are issued in
accordance with Sec.  11.38 and become part of the type certification
basis in accordance with Sec.  21.17(a)(2).
    Special conditions are initially applicable to the model for which
they are issued. Should the type certificate for that model be amended
later to include any other model that incorporates the same novel or
unusual design feature, the special conditions would also apply to the
other model under the provisions of Sec.  21.101.

Novel or Unusual Design Features

    The XtremeAir GmbH XA42 will incorporate the following novel or
unusual design features:
    For acrobatic category airplanes with unlimited acrobatic
capability:

    Neutral longitudinal and lateral static stability characteristics.

Discussion

    The Code of Federal Regulations states static stability criteria
for longitudinal, lateral, and directional axes of an airplane.
However, none of these criteria are adequate to address the specific
issues raised in the flight characteristics of an unlimited aerobatic
airplane. Therefore, the FAA has determined after a flight test
evaluation that, in addition to the requirements of part 21 and part
23, special conditions are needed to address these static stability
characteristics.
    Accordingly, these special conditions are for the XtremeAir GmbH
XA42 static stability characteristics to be certified solely as an
acrobatic category airplane. Other conditions may be developed, as
needed, based on further FAA review and discussions with the
manufacturer and civil aviation authorities.

Discussion of Comments

    A notice of proposed special conditions No. 23-11-02-SC for the
XtremeAir GmbH XA42 airplanes was published in the Federal Register on
December 27, 2011 (76 FR 80829). One comment was received; however, it
appeared to be made in error. It discussed new hire training through
approved 142 training centers, which is not relevant to the acrobatic
category aerodynamic stability special conditions being imposed on
XtremeAir GmbH's XA42 airplane. For this reason, no further action will
be taken and the special conditions are adopted as proposed.

Applicability

    As discussed above, these special conditions are applicable to the
XA42. Should XtremeAir GmbH apply at a later date for a change to the
type certificate to include another model on the same type certificate
incorporating the same novel or unusual design feature, the special
conditions would apply to that model as well.

Conclusion

    This action affects only certain novel or unusual design features
on one model of airplane. It is not a rule of general applicability and
it affects only the applicant who applied to the FAA for approval of
these features on the airplane.

List of Subjects in 14 CFR Part 23

    Aircraft, Aviation safety, Signs and symbols.

Citation

0
The authority citation for these special conditions is as follows:

    Authority: 49 U.S.C. 106(g), 40113 and 44701; 14 CFR 21.16 and
21.17; and 14 CFR 11.38 and 11.19.

The Special Conditions

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the following special conditions are issued as part of
the type certification basis for XtremeAir GmbH XA42 airplanes.

1. Unlimited Acrobatic-Only Category Static Stability Requirements

    For unlimited, acrobatic-only category aircraft, XtremeAir GmbH
XA42 will comply with the following stability special conditions in
lieu of the existing Sec. Sec.  23.171, 23.173, 23.175, and 23.177:
    (A) In place of 14 CFR part 23, Sec.  23.171 Flight--General
(stability) requirement, comply with the following:
    SC23.171 Flight--General: The airplane must be neutrally or
positively stable in the longitudinal, directional, and lateral axes
under sections SC23.173 through SC23.181. In addition, the airplane
must show suitable stability and control ``feel'' (static stability) in
any condition normally encountered in service, if flight tests show it
is necessary for safe operation.
    (B) In place of 14 CFR part 23, Sec.  23.173, Static longitudinal
stability requirement, comply with the following:
    SC23.173 Static longitudinal stability: Under the conditions
specified in SC23.175 and with the airplane trimmed as indicated, the
characteristics of the elevator control forces and the friction within
the control system must be as follows:
    (a) A pull must be required to obtain and maintain speeds below the
specified trim speed and a push required to obtain and maintain speeds
above the specified trim speed. This must be shown at any speed that
can be obtained, except that speeds requiring a control force in excess
of 40 pounds or speeds above the maximum allowable speed or below the
minimum speed for steady unstalled flight need not be considered.
    (b) The stick force or position must vary with speed so that any
substantial speed change results in a stick force or position clearly
perceptible to the pilot.
    (C) In place of 14 CFR part 23, Sec.  23.175, Demonstration of
static longitudinal stability requirement, comply with the following:
    SC23.175 Demonstration of static longitudinal stability:
    (a) Climb. The stick force curve must have, at a minimum, a
neutrally stable to stable slope at speeds between 85 and 115 percent
of the trim speed, with--
    (1) Maximum continuous power; and
    (2) The airplane trimmed at the speed used in determining the climb
performance required by section 23.69(a).
    (b) Cruise. With the airplane in trim with power for level flight
at representative cruising speeds at high and low altitudes, including
speeds up to VNO, except that the speed need not exceed
VH--
    (1) The stick force curve must, at a minimum, have a neutrally
stable to stable slope at all speeds within a range that is the greater
of 15 percent of the trim speed plus the resulting free return speed
range, or 40 knots plus the resulting free return speed range, above
and below the trim speed, except that the slope need not be stable--
    (i) At speeds less than 1.3 VS1; or
    (ii) For airplanes with VNE established under section
23.1505(a), at speeds greater than VNE.
    (c) Landing. The stick force curve must, at a minimum, have a
neutrally stable to stable slope at speeds between 1.1 VS1
and 1.8 VS1 with--
    (1) Landing gear extended; and
    (2) The airplane trimmed at--
    (i) VREF, or the minimum trim speed if higher, with
power off; and
    (ii) VREF with enough power to maintain a 3 degree angle
of descent.
    (D) In place of 14 CFR part 23, Sec.  23.177, Static directional
and lateral stability requirement, comply with the following:
    SC23.177 Static directional and lateral stability:
    (a) The static directional stability, as shown by the tendency to
recover from a wings level sideslip with the rudder free, must be
positive for any landing gear and flap position appropriate to the
takeoff, climb, cruise, approach, and landing configurations. This must
be shown with symmetrical power up to maximum continuous power, and at
speeds from 1.2 VS1 up to the maximum allowable speed for
the condition being investigated. The angle of sideslip for these tests
must be appropriate to the type of airplane. At larger angles of
sideslip, up to that at which full rudder is used or a control force
limit in section 23.143 is reached, whichever occurs first, and at
speeds from 1.2 VS1 to VO, the rudder pedal force
must not reverse.
    (b) In straight, steady slips at 1.2 VS1 for any landing
gear and flap positions, and for any symmetrical power conditions up to
50 percent of maximum continuous power, the rudder control movements
and forces must

increase steadily, but not necessarily in constant proportion, as the
angle of sideslip is increased up to the maximum appropriate to the
type of airplane. The aileron control movements and forces may increase
steadily, but not necessarily in constant proportion, as the angle of
sideslip is increased up to the maximum appropriate to the type of
airplane. At larger slip angles, up to the angle at which the full
rudder or aileron control is used or a control force limit contained in
section 23.143 is reached, the aileron and rudder control movements and
forces must not reverse as the angle of sideslip is increased. Rapid
entry into, and recovery from, a maximum sideslip considered
appropriate for the airplane must not result in uncontrollable flight
characteristics.

    Issued in Kansas City, Missouri, on March 1, 2012.
John R. Colomy,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-6837 Filed 3-23-12; 8:45 am]
BILLING CODE 4910-13-P