Document ID: EPA-HQ-OW-2008-0517-0001
Agency: epa
Document Type: Notice
Title: 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
Posted Date: 2008-08-12T04:00Z

[Federal Register: August 12, 2008 (Volume 73, Number 156)]
[Notices]               
[Page 46903-46906]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12au08-58]                         

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2008-0517, FRL-8703-1]

 
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.

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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: OW-Docket@epa.gov, Attention Docket ID No. EPA-HQ-OW-
2008-0517.
    (3) Mail: Water Docket, Environmental Protection Agency, Mailcode: 
4203M,

[[Page 46904]]

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 (202) 566-1744, and the telephone 
number for the Water Docket is (202) 566-2426.

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 (202) 566-1040; fax number (202) 
566-1053; e-mail address hessenauer.meghan@epa.gov 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 (202) 566-1014; fax 
number (202) 566-1053; e-mail address johnston.carey@epa.gov.

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 (202) 566-2426. 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.

[[Page 46905]]

    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

[[Page 46906]]

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.
[FR Doc. E8-18606 Filed 8-11-08; 8:45 am]

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