E8-18606. Agency Information Collection Activities: Proposed Collection; Comment Request; Study of Unused Pharmaceuticals from Medical and Veterinary Facilities (New), EPA ICR Number 2316.01, OMB Control No. 2040-NEW

AGENCY:

Environmental Protection Agency (EPA).

ACTION:

Notice.

SUMMARY:

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.), this document announces that EPA is planning to submit a proposed Information Collection Request (ICR) to the Office of Management and Budget (OMB). This is a request for a new collection. Before submitting the ICR to OMB for review and approval, EPA is soliciting comments on specific aspects of the proposed information collection as described below.

DATES:

Comments must be submitted on or before November 10, 2008.

ADDRESSES:

Submit your comments, data and information, identified by Docket ID No. EPA-HQ-OW-2008-0517, by one of the following methods:

(1) http://www.regulations.gov. Follow the on-line instructions for submitting comments.

(2) E-mail: [e-mail], Attention Docket ID No. EPA-HQ-OW-2008-0517.

(3) Mail: Water Docket, Environmental Protection Agency, Mailcode: 4203M, 1200 Pennsylvania Ave., NW., Washington, DC 20460, Attention Docket ID No. EPA-HQ-OW-2008-0517. Please include a total of 3 copies.

(4) Hand Delivery: Water Docket, EPA Docket Center, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC, Attention Docket ID No. EPA-HQ-OW-2008-0517. Such deliveries are only accepted during the Docket's normal hours of operation and special arrangements should be made for deliveries of boxed information.

Instructions: Direct your comments to Docket ID No. EPA-HQ-OW-2008-0517. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at http://www.regulations.gov, including any personal information provided, unless the comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information through http://www.regulations.gov or e-mail that you consider to be CBI or otherwise protected. The federal http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If you send an e-mail comment directly to EPA without going through http://www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses.

Docket: All documents in the docket are listed in the index at http://www.regulations.gov. Although listed in the index, some information is not publicly available, i.e., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either electronically at http://www.regulations.gov or in hard copy at the Water Docket in the EPA Docket Center, EPA/DC, EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding holidays. The telephone number for the Public Reading Room is [phone], and the telephone number for the Water Docket is [phone].

FOR FURTHER INFORMATION CONTACT:

Meghan Hessenauer, Engineering and Analysis Division, Office of Science and Technology, Mail Code 4303T, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460; telephone number [phone]; fax number [phone]; e-mail address [e-mail] or Carey Johnston, Engineering and Analysis Division, Office of Science and Technology, Mail Code 4303T, Environmental Protection Agency, 1200 Pennsylvania Ave, NW., Washington, DC 20460; telephone number [phone]; fax number [phone]; e-mail address [e-mail].

SUPPLEMENTARY INFORMATION:

How Can I Access the Docket and/or Submit Comments?

EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OW-2008-0517, which is available for online viewing at http://www.regulations.gov, or in person at the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding holidays. The telephone number for the Water Docket is [phone]. Use http://www.regulations.gov to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the docket, and to access those documents in the public docket that are available electronically.

What Information is EPA Particularly Interested in?

Pursuant to section 3506(c)(2)(A) of the Paperwork Reduction Act, EPA specifically solicits comments and information to enable it to:

(i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(ii) Evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the assumptions used;

(iii) Select appropriate entities to receive the questionnaire in terms of what units (e.g., facilities, offices) should be surveyed; how many should be surveyed; and the criteria used to select them;

(iv) Enhance the quality, utility, and clarity of the information to be collected; and

(v) 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. In particular, EPA is requesting comments from very small businesses (those that employ less than 25 people) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

EPA solicits comments about the questions in each questionnaire and their applicability to the targeted industry. EPA solicits suggestions on how the questions could be changed to be more understandable and to appropriately address facility operations. EPA solicits comments about the scope of the ICR and whether EPA has adequately described the industry sectors that would be subject to the data collection. EPA plans to include health services establishments including hospitals, hospices, long-term care facilities (LTCFs), and veterinary facilities. EPA may consider including veterinary clinics, medical and dental offices, as well as university and prison health clinics within the scope of inquiry and encourages these groups to comment and meet with EPA to discuss their practices. EPA solicits comments on whether EPA has adequately described the population in terms of inclusions and exclusions, and what additional entities, if any, should be included in the scope of the ICR. In DCN 05999 (Docket ID No. EPA-HQ-OW-2008-0517), EPA provides more explanation about its definitions and other considerations related to identifying the appropriate population for the data collection.

What Should I Consider When I Prepare My Comments for EPA?

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible and provide specific examples.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Offer alternative ways to improve the collection activity.

6. Make sure to submit your comments by the deadline identified under DATES.

7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

What Information Collection Activity or ICR Does This Apply to?

Affected Entities: Entities potentially affected by this action are health services establishments including hospitals, hospices, long-term care facilities (LTCFs), and veterinary hospitals. In addition, EPA may include veterinary clinics, medical and dental offices, and university and prison health clinics.

Title: Study of Unused Pharmaceuticals from Medical and Veterinary Facilities (New).

ICR Numbers: EPA ICR No. 2316.01, OMB Control No. 2040-NEW.

ICR Status: This ICR is for a new information collection activity. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register when approved, are listed in 40 CFR Part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR Part 9.

Abstract: This Information Collection Request (ICR) will support EPA's study of unused pharmaceuticals from health care facilities which is part of EPA's overall strategy to address the risks associated with emerging contaminants. This four-pronged strategy is aimed at improving science, communicating risks, identifying partnership and stewardship opportunities, and taking regulatory action as appropriate.

This ICR involved two questionnaires, one for medical facilities and one for veterinary facilities. EPA identified the health services industry as a candidate for a study in the 2006 Clean Water Act (CWA) Section 304(b) Effluent Guidelines Review (71 FR 76661; December 21, 2006). EPA is collecting information about disposal of unused pharmaceuticals to better understand the current management practices and the magnitude of discharges to waters of the United States.

In most respects, the discharge of pharmaceuticals to publicly owned treatment works (POTWs) is not currently regulated or monitored under the federal Clean Water Act and thus, wastewater data are generally not available. Facilities within the health services industry (e.g., hospitals, hospices, long-term care facilities (LTCFs), and veterinary facilities) may dispose of excess, expired, and unwanted medications (referred to collectively as “unused pharmaceuticals”) down the drain or toilet, after which drugs may pass through POTWs and into surface waters.

EPA believes that the health services industry accounts for the majority of institutional (nonresidential) discharges of unused pharmaceuticals to wastewater. Areas for investigation include:

• What are the current industry practices for disposing of unused pharmaceuticals?
• Which pharmaceuticals are being disposed of and at what quantities?
• What are the options for disposing of unused pharmaceuticals other than down the drain or toilet?
• What factors influence disposal decisions?
• Do disposal practices differ within industry sectors?
• What Best Management Practices (BMPs) could facilities implement to reduce the generation of unused pharmaceuticals?
• What reductions in the quantities of pharmaceuticals discharged to POTWs would be achieved by implementing BMPs or alternative disposal methods?
• What are the costs of current disposal practices compared to the costs of implementing BMPs or alternative disposal methods?

To collect this information, EPA will distribute a mandatory questionnaire to a sample of medical and veterinary facilities. There are two versions of the questionnaire, one tailored to facilities that treat people (i.e., hospitals, hospices, and LTCFs) and one tailored to facilities that treat animals (i.e., veterinary facilities). Copies of both questionnaires are available as attachments to the supporting statement.

To complete the questionnaire, respondents will be required to report 30 days worth of pharmaceutical disposal data, which may require development of a tracking system for unused pharmaceuticals and time to train staff on proper tracking protocols. EPA estimates the total respondent burden and costs associated with completing the questionnaires are approximately 145,000 hours and $5,200,000. There are no capital costs associated with responding to these questionnaires. Operation and maintenance (O&M) costs include only photocopying and postage or express delivery. In its calculations of the burden estimates, EPA has assumed that one facility in seven (approximately 3,500 facilities) would be selected to receive the detailed questionnaire.

However, in the actual selection process, EPA intends to use a more sophisticated statistical technique to select facilities. Numerous textbooks and technical journals describe a variety of ways of drawing valid probability samples to collect information that will be representative of the entire population (e.g., Sampling Techniques by William Cochran, 1963). In DCN 05999 (Docket ID No. EPA-HQ-OW-2008-0517), EPA describes several designs that it intends to investigate further before the second Federal Register notice. The selected sampling methodology may result in a larger or smaller sample size. One sample design that EPA is considering is a two-phase design. First, EPA would send a screener questionnaire to a large segment of the population. This screener questionnaire would only contain a few simple questions, but the information would allow EPA to better identify appropriate facilities for the detailed questionnaire. Although EPA might send more questionnaires (i.e., screeners plus detailed questionnaires) under this approach, it might result in a lower overall burden to industry if fewer facilities were selected for the detailed questionnaire.

After evaluating comments, EPA will decide whether or not to include veterinary clinics, medical and dental offices, and university and prison health clinics. EPA will then change the estimated size of the respondent universe as needed. The public will have an opportunity to comment on the selected scope and methodology following publication of the second Federal Register notice associated with this project. Respondents have the option to identify any data submitted as confidential. EPA will treat all confidential submissions according to approved CBI procedures.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 41 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to, or for, a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; 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.

EPA estimates that the total annual burden hours would be approximately 145,000 at a cost of $5,200,000. Additional details on burden can be found in the supporting statement. An overview of the questionnaire burden is provided below:

• Estimated total number of potential respondents: 3,544.
• Frequency of response: 1 time.
• Estimated total average number of responses for each respondent: 1.
• Estimated total annual burden hours: 145,304.
• Average burden hours per respondent: 41.
• Average cost per respondent: $1,463.

What Is the Next Step in the Process for This ICR?

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. At that time, EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the technical persons listed under FOR FURTHER INFORMATION CONTACT.

Dated: July 25, 2008.

Ephraim S. King,

Director, Office of Science and Technology.