[Federal Register Volume 73, Number 156 (Tuesday, August 12, 2008)]
[Notices]
[Pages 46903-46906]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-18606]
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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: [email protected], Attention Docket ID No. EPA-HQ-OW-
2008-0517.
(3) Mail: Water Docket, Environmental Protection Agency, Mailcode:
4203M,
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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 [email protected] 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 [email protected].
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.
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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
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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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