[Federal Register Volume 81, Number 41 (Wednesday, March 2, 2016)]
[Notices]
[Pages 10867-10870]
[FR Doc No: 2016-04569]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0538]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Animation in Direct-to-Consumer Advertising

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on research entitled ``Animation in Direct-to-
Consumer Advertising.'' This study will examine how animation affects
the comprehension of direct-to-consumer (DTC) television advertisements
for prescription drugs.

DATES: Submit either electronic or written comments on the collection
of information by May 2, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-0538 for ``Animation in Direct-to-Consumer Advertising.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION''. The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB

for approval. To comply with this requirement, FDA is publishing notice
of the proposed collection of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Animation in Direct-to-Consumer Advertising--(OMB Control Number 0910--
NEW)

    Section 1701(a)(4) of the Public Health Service Act (42 U.S.C.
300u(a)(4)) authorizes FDA to conduct research relating to health
information. Section 1003(d)(2)(C) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(d)(2)(C)) authorizes FDA to
conduct research relating to drugs and other FDA regulated products in
carrying out the provisions of the FD&C Act.
    Advertisers use many techniques to increase consumer interest in
their ads, including the use of animated spokes-characters. These
characters may be fictional or nonfictional and human or non-human
(Ref. 1). Despite variations in form, animated characters are often
used to grab attention, increase ad memorability, and enhance
persuasion to ultimately drive behavior (Refs. 2, 3, and 4). Although
animated characters have long been used for low-involvement products
(e.g., food products), animation has made its way into direct-to-
consumer prescription drug advertising. However, to our knowledge, no
studies have comprehensively examined how animation affects consumers'
benefit and risk perceptions in drug ads, how various animation
strategies (e.g., symbolizing the disease vs. the benefit) influence
these perceptions, and whether these effects are generalizable across
different patient populations.
    Animation in Drug Ads. Animation is used in prescription drug ads
in a variety of ways. Perhaps the simplest way is the use of rotoscoped
animation, which involves tracing live-action images frame-by-frame to
create animated characters. Abilify has used this technique in
advertisements (Ref. 5). In this instance, the animated character was
not central to the informational content of the ad; instead, the
animation appeared to be a visual technique to attract attention.
Whether a drug ad with a rotoscoped human results in greater
comprehension of product benefit and risk information than an ad with a
human actor is unclear. The few studies that have examined this
technique in drug ads have found that animated human characters either
had no effect on perceived product risk (Ref. 6) or led to poorer
recognition of drug side effects (Ref. 5).
    Animation also has been used in drug ads to symbolize the disease
(e.g., Imitrex and Lamisil ads), the sufferer (e.g., Mybetriq and
Zoloft), the benefit (e.g., Rozerem), the mode of administration (e.g.,
Fluzone), and the mechanism of action (e.g., Lunesta). Drug companies
may use a personified non-human character to illustrate, in a visually
memorable way, the medical condition or drug attributes. Using
secondary data from copy-testing studies, Pashupati found that drug ads
featuring animated characters led to much stronger brand recall and
brand association scores (Ref. 7); however, the other elements of these
studies (e.g., ad characteristics, presence of control group) are
unclear.
    Animated characters may provide marketers with a way to explain
product benefits in an engaging and even humorous manner. Thus, the
majority of research on animated characters in advertising focuses on
outcomes such as product evaluations (Ref. 8), emotional responses
(Refs. 1, 9, and 10), brand attitudes (Ref. 11), and perceived product
value (Ref. 12). The extent to which emotional responses can be
fostered by animated characters is especially relevant to this study,
as the positive effects these animations induce might transfer to the
brands being advertised. It is also possible that animated characters
may lead to lower perceived risk by minimizing or camouflaging side
effects (Ref. 13).
    Animation and Message Communication. Personifying animated
characters may interfere with message communication. Although
personification may increase involvement with the characters in the ad
(i.e., perceived as engaging and likeable), it may not increase
involvement with the message itself (e.g., risk and benefit
information). Whether personified characters lead to reduced
comprehension of risk and benefit information in drug ads is an
important and unanswered question. Based on a theory called the limited
capacity model of mediated message processing (Ref. 14), advertising
content that is engaging, relevant, and maximizes audio/visual
redundancy should improve learning and memory (Ref. 15). However,
others argue that the entertainment aspects can distract from learning
key information and may lead to message complexity that interferes with
message communication (Ref. 16).
    It is important to examine whether animation in drug ads inflates
efficacy perceptions, minimizes risk, or otherwise hinders
comprehension of drug risks and benefits. To investigate these issues,
we will conduct a two-part experimental study to examine how: (1) Type
of animation and (2) non-human personification in drug ads influence
consumer comprehension, processing, and perception of risk and benefit
information. Understanding how issues of animation and personification
affect perceptions of both risks and benefits can inform FDA regarding
how prescription drug risk and benefit information is processed. These
strategies will be examined across two different medical conditions to
see if the findings are consistent across patient populations and
medications with different levels of risk.

General Research Questions

    1. How does consumer processing of a DTC prescription drug ad
differ depending on whether the ad is live-action, rotoscoped, or
animated?
    2. Does consumer processing differ depending on whether the
sufferer, the disease, or the benefit is the focus of the animation?

Design

    To test these research questions, we will conduct two experiments.
Both experiments will be examined in two different medical conditions:
chronic dry eye, and psoriasis. The mock drugs we will create for these
conditions mimic currently available medications and were chosen for
their variance in serious side effects, i.e., medications for psoriasis
have very long, serious lists of risks and side effects, whereas
chronic dry eye medications have relatively few risks and side effects.
    The first experiment will examine whether animation itself
influences consumer processing, defined as consumer recall of risks and
benefits, perceptions of risks and benefits, and attitudes and
emotional responses to the ad, the brand, the product, and the
character (table 1). We will examine two different types of animation
in addition

to a control ad which will be shot with live actors: An ``in-between''
animation technique, rotoscoping, in which live scenes are drawn to
look animated, and full animation with nonhuman characters. The live
action and rotoscoped ad will be identical except for the rotoscope
treatment. The animated ad will follow the theme and message as closely
as possible within the limitations of animation itself. The benefits
and risks of the product will be identical, although the ad's storyline
may vary somewhat to account for a nonhuman protagonist.

                                     Table 1--Experiment 1 Animation Design
                                               [Type of Animation]
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                                                                  Non-human        Rotoscoped
                      Medical condition                            sufferer     human  sufferer  Human  sufferer
----------------------------------------------------------------------------------------------------------------
Chronic Dry Eye..............................................
Psoriasis....................................................
----------------------------------------------------------------------------------------------------------------

    The second experiment will examine whether the object of the
animation influences consumer processing of the ad (table 2), defined
as consumer recall of risks and benefits, perceptions of risks and
benefits, and attitudes and emotional responses to the ad, the brand,
the product, and the character. The animation will focus on the
animated character who will personify either the sufferer of the
medical condition, the disease itself, or the benefit from the drug. In
this study, all ads will contain the same kind of full animation and
the general theme will be as similar as possible, accounting for the
variations in focus of character. The experiments will be conducted
concurrently, and the same participants in the nonhuman sufferer groups
will be part of both.

                                  Table 2--Experiment 2 Personification Design
                                           [Non-Human Personification]
----------------------------------------------------------------------------------------------------------------
               Medical condition                    Sufferer         Disease          Benefit
-------------------------------------------------------------------------------------------------
Chronic Dry Eye...............................
Psoriasis.....................................
----------------------------------------------------------------------------------------------------------------

    In both cases, a professional firm will create all ads such that
they are indistinguishable from currently running DTC ads.
    Pretesting will take place before the main study to evaluate the
procedures and measures used in the main study. We will recruit adults
who fall into one of four age brackets shown in table 1. We will
exclude individuals who work in healthcare or marketing settings
because their knowledge and experiences may not reflect those of the
average consumer. A prior power analyses revealed that we need 300
participants for the pretest to obtain 80% power to detect a moderately
small effect size. Each experiment will include 30 participants per
condition for a total of 180 participants each, but 60 of those in the
nonhuman sufferer conditions will overlap between the two experiments.
We will need 1,500 unique participants for the main study to obtain 90%
power to detect a moderately small effect size. There will be 150
participants per condition for a total of 900 participants in each
experiment, with 300 participants in the overlapping nonhuman sufferer
conditions.
    In both studies, participants who have been diagnosed with either
chronic dry eye or psoriasis will be recruited via opt-in Internet
panel to watch one ad for a prescription drug that treats their medical
condition. In study 1, participants will be randomly assigned to view
either a live-action, rotoscoped, or fully animated ad. All themes in
study 1 will focus on the main character as the sufferer of the
condition. In study 2, participants will be randomly assigned to a
personification condition: sufferer, disease, or benefit. All ads in
study 2 will be fully animated. Participants will watch the ad twice
and then answer an online survey with questions addressing recall of
risks and benefits, perceptions of risks and benefits, and attitudes
and emotional responses to the ad, the brand, the product, and the
character. The questionnaire is available upon request. Participation
is estimated to take approximately 25 minutes.
    To examine differences between experimental conditions, we will
conduct inferential statistical tests such as analysis of variance
(ANOVA).
    With online surveys, several participants may be completing the
survey at the time that the total target sample is reached. Those
participants are allowed to complete the survey, which can result in
the number of completes going slightly over the target number. Thus,
our target number of completes is 1,500, so we have rounded up by an
additional 150, or 10%, to allow for some overage.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 3--Estimated Annual Reporting Burden \1\
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                                                  Number of
            Activity               Number of    responses per  Total annual    Average  burden per   Total Hours
                                  respondents    respondent      responses          response
----------------------------------------------------------------------------------------------------------------
                                                   Pretesting
----------------------------------------------------------------------------------------------------------------
Number to complete the screener           660               1           660  0.08 (5 min.).........           53
 (assumes 50% eligible).
Number of completes............           330               1           330  .42 (25 min.).........          139
----------------------------------------------------------------------------------------------------------------

                                                   Main Study
----------------------------------------------------------------------------------------------------------------
Number to complete the screener         3,300               1         3,300  0.08 (5 min.).........          264
 (assumes 50% eligible).
Number of completes............         1,650               1         1,650  .42 (25 min.).........          693
                                --------------------------------------------------------------------------------
    Total Hours................  ............  ..............  ............  ......................        1,149
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov.

References

1. Callcott MF, Lee W. ``Establishing the Spokes-Character in
Academic Inquiry: Historical Overview and Framework for
Definition,'' Advances in Consumer Research, 1995;22:144-151.
2. Bell JA. Creativity, TV Commercial Popularity, and Advertising
Expenditures, Internationl Journal of Advertising, 1992;11(2):165-
72.
3. Heiser RS, Sierra JJ, Torres IM. ``Creativity Via Cartoon
Spokespeople in Print Ads: Capitalizing on the Distinctiveness
Effect,'' Journal of Advertising, 2008;37(4):75-85.
4. Luo JT, McGoldrick P, Beatty S, et al, ``On-Screen Characters:
Their Design and Influence on Consumer Trust,'' Journal of Services
Marketing, 2006;20(2):112-24.
5. Clayton RB, Lesher G. ``The Uncanny Valley: The Effects of
Rotoscope Animation on Motivational Processing of Depression Drug
Messages,'' Journal of Broadcasting and Electronic Media,
2015;59(1):57-75.
6. Bhutada NS, Rollins BL, Perri M. ``Animation in Print Direct-to-
Consumer Advertising of Prescription Drugs: Impact on Consumers,''
at the 32d Association for Marketing and Healthcare Research Annual
Meeting and Conference, February 27-March 1, 2013, Big Sky, MT.
7. Pashupati K. ``Beavers, Bubbles, Bees, and Moths: An Examination
of Animated Spokescharacters in DTC Prescription Drug Advertisements
and Web sites,'' Journal of Advertising Research, 2009;49(3):373-93.
8. Chandler J, Schwarz N. ``Use Does Not Wear Ragged the Fabric of
Friendship: Thinking of Objects as Alive Makes People Less Willing
to Replace Them,'' Journal of Consumer Psychology, 2010;20(2):138-
145.
9. Callcott MF, Phillips BJ., ``Observations: Elves Make Good
Cookies: Creating Likeable Spokescharacter Advertising,'' Journal of
Advertising Research, 1996;36(5):73-79.
10. Garretson JA, Niedrich RW., ``Spokes-Characters: Creating
Character Trust and Positive Brand Attitudes,'' Journal of
Advertising, 2004;33(2):25-36.
11. Delbaere M, McQuarrie EF, Phillips BJ, ``Personification in
Advertising: Using a Visual Metaphor to Trigger Anthropomorphism,''
Journal of Advertising, 2011;40(1):121-130.
12. Hart PM, Jones SR, Royne MB, ``The Human Lens: How
Anthropomorphic Reasoning Varies by Product Complexity and Enhances
Personal Value,'' Journal of Marketing Management, 2013;29(1-2):105-
121.
13. Moyer-Guse E, Mahood C, Brookes S., ``Entertainment-Education in
the Context of Humor: Effects on Safer Sex Intentions and Risk
Perceptions,'' Health Communication, 2011;26(8):765-774.
14. Lang A., ``The Limited Capacity Model of Motivated Mediated
Message Processing,'' The Sage Handbook of Mass Media Effects, New
York: Sage;2009:193-204.
15. Garretson JA, Burton S., ``The Role of Spokescharacters as
Advertisement and Package Cues in Integrated Marketing Campaigns,''
Journal of Marketing, 2005;69(4):118-132.
16. Lang A., ``Using the Limited Capacity Model of Motivated
Mediated Message Processing to Design Effective Cancer Communication
Messages,'' Journal of Communication, 2006;56:557-580.

    Dated: February 23, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-04569 Filed 3-1-16; 8:45 am]
 BILLING CODE 4164-01-P


SUPPORTING STATEMENT

ENVIRONMENTAL PROTECTION AGENCY

Emission Guidelines for Commercial and Industrial Solid Waste Incineration Units (Renewal) (40 CFR part 60, subpart DDDD)

1.  Identification of the Information Collection

	1(a)  Title of the Information Collection

Emissions Guidelines for Commercial and Industrial Solid Waste Incineration Units (40 CFR part 60, subpart DDDD)

	1(b)  Short Characterization/Abstract

	The Emission Guidelines for Commercial and Industrial Solid Waste Incineration (CISWI) Units were promulgated on December 1, 2000.  The guidelines (standards) apply to solid waste incinerators in 40 CFR part 60, subpart DDDD.  These standards fulfill the requirements of sections 111 and 129 of the Clean Air Act (CAA).  This subpart affects the Administrator of an air quality program in a state, or United States protectorate with one or more existing CISWI units that commenced construction on, or before November 30, 1999.

	The emissions guidelines require: a one-time waste management plan; initial performance tests for ten pollutants; annual performance testing for particulate matter (PM), hydrogen chloride (HCl), and opacity; continuous operating parameter monitoring; annual operator training; and annual reporting.  A semiannual deviation report is required if any of the emission limitations, or operating limits are exceeded.  The frequency of these activities was chosen by the United States Environmental Protection Agency (EPA) as the period that will provide an adequate margin of assurance that affected facilities will not operate for extended periods in violation of the standards.

	This supporting statement addresses information collection activities imposed by the Emission Guidelines for Commercial and Industrial Solid Waste Incineration (CISWI) Units, subpart DDDD.  The guidelines do not apply directly to CISWI unit owners and operators.  The guidelines are implemented through the State Implementation Plans (SIP), written by the states.  If a state does not develop, adopt, and submit an approved state plan, and if a state’s plan is not approved, the EPA must promulgate a Federal Implementation Plan to implement the emission guidelines in a state without its own SIP.

	The information will be used by enforcement and compliance authorities to ensure that the requirements of the state, or Federal plans are implemented and the subject facilities comply with the plans on a continuous basis.  Specifically, the information will be used by the authorities to: 1) identify existing sources subject to the standards; 2) ensure those existing sources have a control plan to achieve compliance by the final compliance date; 3) ensure that subpart DDDD is being properly applied; 4) ensure that the emission standards are being complied with; and 5) ensure, on a continuous basis, that the operating parameters established during the initial stack test are not exceeded.

	In addition, records and reports are necessary to enable the authorities to identify CISWI units that are not in compliance with the standards.  Based on reported information, the designated Administrator can decide which CISWI units should be inspected and what records or processes should be inspected at the CISWI unit.  The records that CISWI units maintain would indicate to the Administrator whether personnel are operating and maintaining the control equipment properly and whether they have met the qualification requirements.  In more than 95 percent of the cases, the enforcement of emission guidelines has been delegated to the state air pollution control agencies.  In such cases, the reports required by the standards will be submitted to the appropriate state agency, and not directly to the EPA.  Thus, there is a minimal possibility for the duplication of information to state agencies and EPA.  In those few cases where state agencies have not developed a state plan, or requested delegation of the Federal plan, Federal enforcement still requires information from the CISWI facility.  The plant owner, or operator may submit a copy of state, or local reports to the Administrator in lieu of the report required by the standards, as specified in the General Provisions of 40 CFR part 60.

	This rule requires all records to be maintained at the source for a period of five years.  These records must be kept on file for use, if needed by the regulating authority to ensure that the plant personnel are operating and maintaining control equipment properly.

	There are approximately 97 respondents that will be subject to the standard in the next three years.  The previous ICR assumed that the facilities regulated under the Emission Guidelines are owned by “business or other for-profit,” Federal, and “State, Local; or Tribal Government.”  Recent data indicate that the ownership is limited to the private industry.  The average annual labor cost of this ICR is $1,233,907.

	The Office of Management and Budget (OMB) approved the current Information Collection Request (ICR) without any “Terms of Clearance.”

2.  Need for and Use of the Collection

	2(a)  Need/Authority for the Collection

The EPA is charged under section 111(d)(1) of the Clean Air Act (CAA), as amended, to:

. . . prescribe regulations which shall establish a procedure similar to that provided by section 110 under which each State shall submit to the Administrator a plan which (A) establishes standards of performance for any existing source for any air pollutant (i) for which air quality criteria have not been issued or which is not included on a list published under section 108(a) . . . but (ii) to which a standard of performance under this section would apply if such existing source were a new source, and (B) provides for the implementation and enforcement of such standards of performance.

	The EPA is required under section 129 of the Act, to establish guidelines for existing stationary sources that reflect the maximum achievable control technology (MACT) for achieving continuous emission reductions:

	Section 129(a)(1)(A) states:

The Administrator shall establish performance standards and other requirements pursuant to section 111 and this section for each category of solid waste incineration units.  Such standards shall include emissions limitations and other requirements applicable to new units and guidelines (under section 111(d) and this section) and other requirements applicable to existing units.

	Section 129(a)(2) states:

Standards applicable to solid waste incineration units promulgated under section 111 and this section shall reflect the maximum degree of reduction in emissions of air pollutants listed under section (a)(4) that the Administrator, taking into consideration the cost of achieving such emission reduction, and any non-air quality health and environmental impacts and energy requirements, determines is achievable for new or existing units in each category.

Section 129(b)(1) states:

Performance standards under this section and section 111 for solid waste incineration units shall include guidelines promulgated pursuant to section 111(d) and this section applicable to existing units.  Such guidelines shall include, as provided in this section, each of the elements required by subsection (a) (emissions limitations, notwithstanding any restriction in section 111(d) regarding issuance of such limitations), subsection (c) (monitoring), subsection (d) (operator training), subsection (e) (permits), and subsection (h)(4) (residual risk).

Subpart B of 40 CFR part 60 requires state plans to include monitoring, recordkeeping, and reporting provisions consistent with the emission guidelines.  In addition, section 114(a)(1) states that:

the Administrator may require any person who owns or operates any emission source, who manufactures emission control equipment or process equipment, who the Administrator believes may have information necessary for the purposes set forth in this subsection, or who is subject to any requirement of this Act (other than a manufacturer subject to the provisions of section 206(c) or 208 with respect to a provision of title II) on a one-time, periodic or continuous basis to:

(A) establish and maintain such records; (B) make such reports; (C) install, use, and maintain such monitoring equipment, and use such audit procedures, or methods; (D) sample such emissions (in accordance with such procedures or methods, at such locations, at such intervals, during such periods and in such manner as the Administer shall prescribe); (E) keep records on control equipment parameters, production variables or other indirect data when direct monitoring of emissions is impractical; (F) submit compliance certifications in accordance with section 114(a)(3); and (G) provide such other information, as the Administrator may reasonably require; . . . .

	Certain reports are necessary to enable the regulatory agencies to identify existing sources subject to the state plan that implements the emission guidelines and to determine if the standards are being achieved.  Therefore, the emission guidelines were promulgated for this source category at 40 CFR part 60, subpart DDDD.

	2(b)  Practical Utility/Users of the Data

	The information will be used by EPA, state, or local enforcement personnel to ensure that the requirements of the state (or Federal) plan are being implemented and the subject facilities comply with the requirements of the plans on a continuous basis.  Specifically, the information will be used to: (1) identify existing sources subject to the standards; (2) ensure that those existing sources have a control plan to achieve compliance by the final compliance date; (3) ensure that subpart DDDD is being properly applied; (4) ensure that the emission standards are being complied with; (5) ensure, on a continuous basis, that the operating parameters established during the initial performance test are not exceeded.

	In addition, records and reports are necessary to enable the authorities to identify CISWI units that may not be in compliance with the standards.  Based on reported information, the authorities can decide which CISWI units should be inspected and what records or processes should be inspected at the CISWI unit.  The records that CISWI units maintain would indicate to the authorities whether the personnel are operating and maintaining control equipment properly and whether they have met the qualification requirements.

3.  Nonduplication, Consultations, and Other Collection Criteria

	The requested recordkeeping and reporting are required under 40 CFR part 60, subpart DDDD.

	3(a)  Nonduplication

	If the subject standards have not been delegated, the information is sent directly to the appropriate EPA regional office.  Otherwise, the information is sent to the delegated state, or local agency.  If a state, or local agency has adopted its own similar standards to implement the Federal standards, a copy of the report submitted to the state, or a local agency can be sent to the Administrator in lieu of the report requirement by the Federal standards.  Therefore, no duplication exists.

	3(b)  Public Notice Required Prior to ICR Submission to OMB

	An announcement of a public comment period for the renewal of this ICR was published in the Federal Register on June 21, 2006 (71 FR 35652).  No comments were received on the burden published in the Federal Register.

	3(c)  Consultations

	It is our policy to review any comments received since the last ICR renewal including those submitted in response to the first Federal Register notice and respond appropriately.  No comments were received for this ICR.

The primary source of information was the industry and EPA data including an assessment by the Office of Air and Radiation.  Information provided by the industry is retained in the EPA’s Air Facility System (AFS) database, which is operated and maintained by EPA’s Office of Compliance.  AFS is EPA’s database for the collection, maintenance, and retrieval of all compliance data.  Approximately 97 respondents are currently subject to the regulation.  The Agency estimates that there will not be any industry growth in the next three years.

It should be noted that the industry trade associations and other interested parties were provided an opportunity to comment on the burden associated with the standard when it was proposed and the standard was previously reviewed to determine the minimum information needed for compliance purposes.  No major problems regarding the rule monitoring, recordkeeping, or reporting were identified during the public comment period.

3(d)  Effects of Less Frequent Collection

	Less frequent information collection would decrease the margin of assurance that facilities are continuing to meet the standards.  Requirements for information gathering and recordkeeping are useful techniques to ensure that good operation and maintenance practices are applied and emission limitations are met.  If the information required by these standards was collected on a less frequent basis, the likelihood of detecting poor operation and maintenance of control equipment and noncompliance would decrease.

	3(e)  General Guidelines

	None of these reporting or recordkeeping requirements violates any of the regulations established by OMB at 5 CFR part 1320, section 1320.5.

	These standards require affected facilities to maintain all records, including reports and notifications for at least five years.  This is consistent with the General Provisions as applied to the standards.  EPA believes that the five-year records retention requirement is consistent with the part 70 permit program and the five year statute of limitations on which the permit program is based.  Also, the retention of records for five years would allow EPA to establish the compliance history of a source and any pattern of compliance for purposes of determining the appropriate level of enforcement action.  Historically, EPA has found that the most flagrant violators frequently have violations extending beyond the five years.  EPA would be prevented from pursuing the worst violators due to the destruction or nonexistence of records if records were retained for less than five years.

	3(f)  Confidentiality

	The required information has been determined not to be confidential.  However, any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to the Agency policies set forth in title 40, chapter 1, part 2, subpart B - Confidentiality of Business Information (see 40 CFR 2; 41 FR 36902, September 1, 1976; amended by 43 FR 40000, September 8, 1978; 43 FR 42251, September 20, 1978; 44 FR 17674, March 23, 1979).

	3(g)  Sensitive Questions

	None of the reporting, or recordkeeping requirements contains sensitive questions.

4.  The Respondents and the Information Requested

	4(a)  Respondents/SIC and NAICS Codes

	The respondents to the recordkeeping and reporting requirements are commercial and industrial solid waste incineration (CISWI) units.  The United States Standard Industrial Classification (SIC) codes which correspond to the North American Industry Classification System (NAICS) codes could be found in the following table.

Standard	SIC Codes	NAICS Codes

Emission Guidelines for Commercial and Industrial Solid Waste Incineration Units (40 CFR, part 60, subpart DDDD)

Manufacturers of chemicals and allied products	28	325

Manufacturers of electronic equipment	34	325

Manufacturers of wholesale trade, durable goods	36	421

Manufacturers of lumber and wood furniture	24	321

Manufacturers of wholesale trade, durable goods	25	337

Law enforcement agencies	9229	922

Department of Defense (labs, military bases, munition facilities)	9711 928

Research centers	8221	6113

	4(b)  Information Requested

		(i)  Data Items

	All data in this ICR that are recorded and/or reported are required by the Emission Guidelines for Commercial and Industrial Solid Waste Incineration (CISWI) Units (40 CFR part 60, subpart DDDD).

A source must make the following reports:

Notification Reports	Standard Citation by Section

Notification of final control plan	60.2600(a)

Notification of final compliance	60.2605

Submit waste management plan	60.2755

Notification of initial and subsequent performance tests	60.2760

Notification of closure	60.2615

Annual report	60.2765 and 60.2770

Emission limitation or operating limit deviation report	60.2775, and 60.2780

Qualified operator deviation notification	60.2785(a)(1)

Status Report for operators that are off-site more than two weeks 60.2785(a)(2)

Notification of resumed operation	60.2785(b)

Notification until increment is met	60.2595

A source must keep the following records:

Recordkeeping

Records of initial performance tests, annual performance tests, and any subsequent performance tests.	60.2740(f)

Maintain records of days for which data on operating parameters have been obtained.  Includes a list of operating parameters not measured, reason for not measuring, and a description of corrective actions taken. 60.2740(c)

Maintain records of occurrence and duration of any malfunction and the corrective action taken.	60.2740(d)

Maintain records of days when deviation from operating limits has occurred, and description of corrective actions taken.	60.2740(e)

Maintain records of names of persons who have completed review of site-specific information and incinerator operating procedures. 60.2740(g) and 60.2660(c)

Maintain records of names of persons who have completed the operator training requirements.	60.2740(h)

Maintain records of phone and/or pager numbers of persons who have met the operator qualification criteria.	60.2740(i)

Maintain records of calibration of monitoring devices.	60.2740(j)

Maintain records of equipment vendor specifications for the incinerator, emission controls, and monitoring equipment.	60.2740(k)

Maintain records of daily log of quantity and types of waste burned. 60.2740(m)

Maintain records of site-specific information and incinerator operation procedures.	60.2660(c)

Maintain records of operating parameters.	60.2740(b)

Maintain calendar date of each record.	60.2740(a)

Retain records for five years.	60.2740

Electronic Reporting

	Currently, sources are using monitoring equipment that provides parameter data in an automated way (e.g., leaks and spills of mercury).  Personnel at the source will still need to evaluate the data.  This type of monitoring equipment has significantly reduced the burden associated with monitoring and recordkeeping.  In addition, some regulatory agencies are setting up electronic reporting systems to allow sources to report electronically which reduces the reporting burden.  However, electronic reporting systems are still not widely used by the regulatory agencies.  It is estimated that approximately 10 percent of the respondents use electronic reporting.

		(ii)  Respondent Activities

Respondent Activities

Read instructions.

Install, calibrate, maintain, and operate control devices for, PM, HCl, and opacity.

Perform initial and annual performance tests.

Write the notifications and reports listed above.

Enter information required to be recorded above.

Submit the required reports developing, acquiring, installing, and utilizing technology and systems for the purpose of collecting, validating, and verifying information.

Develop, acquire, install, and utilize technology and systems for the purpose of processing and maintaining information.

Develop, acquire, install, and utilize technology and systems for the purpose of disclosing and providing information.

Train personnel to be able to respond to a collection of information.

Transmit, or otherwise disclose the information.

5.  The Information Collected: Agency Activities, Collection Methodology, and Information Management

	5(a)  Agency Activities

	EPA conducts the following activities in connection with the acquisition, analysis, storage, and distribution of the required information.

Agency Activities

Review notifications and reports, including performance test reports, and excess emissions reports, required to be submitted by industry.

Audit facility records.

Input, analyze, and maintain data in the Air Facility System.

Observe compliance tests (optional)

	5(b)  Collection Methodology and Management

	Following notification of startup, the reviewing authority might inspect the source to determine whether the pollution control devices are properly installed and operated.  Performance test reports are used by the Agency to discern a source’s initial capability to comply with the emission standard, and the operating conditions under which compliance was achieved.  Data and records maintained by the respondents are tabulated and published for use in compliance and enforcement programs.

	Information contained in the reports is entered into the AFS, which is operated and maintained by EPA's Office of Compliance.  AFS is EPA’s database for the collection, maintenance, and retrieval of compliance and annual emission inventory data for more than 125,000 industrial and government-owned facilities.  EPA uses the AFS for tracking air pollution compliance and enforcement by local and state regulatory agencies, EPA regional offices and EPA headquarters.  EPA and its delegated authorities can edit, store, retrieve and analyze the data.

	The records required by this regulation must be retained by the owner or operator for five years.

	5(c)  Small Entity Flexibility

	A majority of the affected facilities are large entities (e.g., large businesses).  However, the impact on small entities (i.e., small businesses) was taken into consideration during the development of the regulation.  Due to technical considerations involving the process operations and the types of control equipment employed, the recordkeeping and reporting requirements are the same for both small and large entities.  The Agency considers these requirements the minimum needed to ensure compliance and, therefore, cannot reduce them further for small entities.  To the extent that larger businesses can use economies of scale to reduce their burden, the overall burden will be reduced.

	The rules contain several provisions that reduce the impact of the rule on all regulated entities, which include small entities.  These are: annual performance testing is only required for three pollutants rather than the full ten pollutants included in the initial performance tests; operating parameter monitoring is required instead of continuous emissions monitoring systems (CEMS); the owner or operator is allowed to skip two annual performance tests for a pollutant if all performance tests over the previous three years show compliance; and deviation reports are only required if there is a deviation, otherwise reporting is annual.

	5(d)  Collection Schedule

	The specific frequency for each information collection activity within this request is shown in Table 1: Annual Industry Burden for Emissions Guidelines for Commercial and Industrial Solid Waste Incineration Units (40 CFR part 60, subpart DDDD).

6.  Estimating the Burden and Cost of the Collection

	Table 1 documents the computation of individual burdens for the recordkeeping and reporting requirements applicable to the industry for the subpart included in this ICR.  The individual burdens are expressed under standardized headings believed to be consistent with the concept of a burden under the Paperwork Reduction Act.  Where appropriate, specific tasks and major assumptions have been identified.  Responses to this information collection are mandatory.

	The 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.

	6(a)  Estimating Respondent Burden

	The average annual burden to industry over the next three years from these recordkeeping and reporting requirements is estimated to be 31,619.8 hours (Total Labor Hours from Table 1).  These hours are based on Agency studies and background documents from the development of the regulation, Agency knowledge and experience with the Emissions Guidelines program, the previously approved ICR, and any comments received.

	6(b)  Estimating Respondent Costs

		(i)  Estimating Labor Costs

	This ICR uses the following labor rates:  $100.99 per hour for Executive, Administrative, and Managerial labor, $87.97 per hour for Technical labor, and $43.81 per hour for Clerical labor.  These rates are from the United States Department of Labor, Bureau of Labor Statistics, December 2005, “Table 2. Civilian Workers, by occupational and industry group.”  The rates have been increased by 110 percent to account for the benefit packages available to those employed by private industry.

	Managerial	$100.99   ($48.09 + 110%)

Technical	$87.97     ($41.89 + 110%)

	Clerical	$43.81     ($20.86 + 110%)

		(ii)  Estimating Capital/Startup and Operation and Maintenance Costs

	The types of industry cost associated with the information collection activities in the subject standard are both labor costs which are addressed elsewhere in this ICR and the cost associated with continuous monitoring.  The capital/startup costs are one time cost when a facility becomes subject to the regulation.  The annual operation and maintenance costs are the ongoing costs to maintain the monitors and other costs, such as photocopying and postage.

(iii)  Capital/Startup vs. Operation and Maintenance (O&M) Costs

(A)

Capital/Startup Cost for One Respondent1	(B)

Number of Initial Respondents2	(C)

Total Capital/Startup Cost

(A x B)	(D)

Annual O&M Costs for One Respondent3	(E)

Number of Respondents with O&M 2	(F) Total O&M, (E x F)	(G)

Total

(C + F)

$2,240	0	$0	$211	97 	$20,467	$20,467

		1  The capital/startup costs and O&M could be found in Table 1 under column “Non-labor costs per occurrence per respondent” and “Total non-labor costs per year”.  Section 3B(1e) and (2d).

		2  See Section 6(d) for calculation.

		3  We assume that the annual O&M cost are $211 per year.

	The total capital/startup costs for this ICR are zero.  This is the total of column C in the above table.  The total operation and maintenance (O&M) costs for this ICR are $20,467.  This is the total of column F.  The total respondent costs have been calculated as the addition of the capital/startup costs, and the annual operation and maintenance costs.  The average annual cost for capital/startup and operation and maintenance cost to industry over the next three years of this ICR is estimated to be $20,467.

	6(c)  Estimating Agency Burden and Cost

	The only costs to the Agency are those costs associated with analysis of the reported information.  EPA's overall compliance and enforcement program includes activities such as the examination of records maintained by the respondents, periodic inspection of sources of emissions, and the publication and distribution of collected information.

	The average annual Agency cost during the three years of the ICR is estimated to be $87,648.  This cost is based on the average hourly labor rate at a GS-12, Step 1, times 1.6 benefits multiplication factor to account for government overhead expenses.  The rates are as follows:

	Managerial	$57.20   (GS-13, Step 5, $35.75 x 1.6)

Technical	$42.45   (GS-12, Step 1, $26.53 x 1.6)

	Clerical	$22.96   (GS-6, Step 3, $114.35 x 1.6)

These rates are from the Office of Personnel Management (OPM) “2006 General Schedule” which excludes locality rates of pay.  Details upon which this estimate is based appear in Table 2: Annual EPA Burden - Emissions Guidelines for Commercial and Industrial Solid Waste Incineration Units (40 CFR part 60, subpart DDDD).

	6(d)  Estimating the Respondent Universe and Total Burden and Costs

	As shown above, the average Number of Respondents over the three-year period of this ICR is 97.

Number of Respondents

	Respondents That Submit Reports	Respondents That Do Not Submit Any Reports

	Year	(A)

Number of Initial Respondents 	(B)

Number of Existing Respondents 	(C)

Number of Existing Respondents That Keep Records but do not submit reports	(D)

Number of Existing Respondents with Initial Requirements	(E)

Number of Respondents (E=A+B+C-D)

Average	0	97	0	0	97

The total number of annual responses per year is calculated using the following table:

Total Annual Responses

(A)

Number of Initial Respondents	(B)

Number of Reports for Initial Respondents	(C)

Number of Existing Respondents	(D)

Number of Reports for Existing Respondents	(F)

Number of Existing Respondents that keep records but do not submit reports	(E)

Total Annual Responses E=(AxB)+(CxD)

0	0	97	1.41	0	136 (Rounded)

1 Each existing respondent submits an annual report, 10 percent submit an operator status notification of resumed operation, 10 percent submit status report for operators that are off-site for more than two weeks, 10 percent submit a corrective action summary report, and 10 percent submit a semiannual exceedance report.  Total number of reports per respondent is 1.4 per year.

	The number of Total Annual Responses from the 97 respondents is 136.  The Total Hours Requested is 31,619.8.  The total annual labor costs are $2,884,100.  Details of the labor cost estimates may be found in Table 1. Annual Respondent Burden and Cost, Emission Guidelines for Commercial and Industrial Solid Waste Incineration Units (40 CFR part 60, subpart DDDD).

	Note that the total annual capital and O&M costs to the regulated entity are $20,467.  These costs are detailed in Section 6(b)(iii), Capital/Startup vs. Operation and Maintenance (O&M) Costs.

	6(e)  Bottom Line Burden Hours Burden Hours and Cost Tables

	The bottom line burden hours and cost tables for both the Agency and the respondents are attached.  The annual public reporting and recordkeeping burden for this collection of information is estimated to average 211 hours per response.

	6(f)  Reasons for Change in Burden

The decrease in burden from the most recently approved ICR is due to no new facilities and thus no initial burden under this ICR.  In the active ICR, EPA assumed that there would be six new facilities a year over the past three years.  The Agency’s most recent estimate indicates that there will be no new facilities over the next three years and that the total number of facilities is unchanged (97).

	6(g)  Burden Statement

	The annual public reporting and recordkeeping burden for this collection of information is estimated to average 211 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; 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 valid OMB control number.  The OMB control numbers for EPA’s regulations are listed at 40 CFR part 9 and 48 CFR chapter 15.

	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 Number EPA-HQ-OECA-2006-0444.  An electronic version of the public docket is available at   HYPERLINK "http://www.regulations.gov/"  http://www.regulations.gov/  which may be used 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.  When in the system, select “search,” then key in the docket ID number identified in this document.  The documents are also available for public viewing at the Enforcement and Compliance Docket and Information Center in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, N.W., Washington, D.C.  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<PHONE_NUMBER>, and the telephone number for the docket center (202) 566-1752.  Also, comments may be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, N.W., Washington, D.C. 20503, Attention: Desk Officer for EPA.  Please include the EPA Docket ID Number EPA-HQ-OECA-2006-0444 and OMB Control Number 2060-0451 in any correspondence.

Part B of the Supporting Statement

	This part is not applicable because no statistical methods were used in collecting this information.

TABLE 1:  Annual EPA Burden - Emission Guidelines for Commercial and Industrial Solid Waste Incineration Units (40 CFR Part 60, Subpart DDDD)

Burden Items	(A)

Respondent Hours per Occurrence (Technical hours)	(B)

Number of Occurrences Per Respondent Per Year	(C)

Hours Per Respondent Per Year

(C = A x B)	(D)

Number of Respondents Per Year	(E)

Technical Hours Per Year @$87.97

(C x D) b	(F)

Management Hours Per Year @$100.99

(E x 0.05) b 	(G)

Clerical Hours Per Year @$43.81

(E x 0.1) b	(H)

Total Labor Costs

Per Year b	(I)

Emission Testing Contractor Hours Per Occurrence per Respondent	(J)

Emission Testing Contractor Hours Per Year

(D x I)	(K)

Non-Labor Costs Per Occurrence per Respondent	Total Contractor/ Non-Labor Costs Per Year

(D x K) +

(J x $100) k

1.	APPLICATIONS	N/A

	2.	SURVEY AND STUDIES	N/A

	3.	REPORTING REQUIREMENTS

New Sources

	A.  Read Instructions c&d	16	1 	16 	0 	0 	0	0 	$0	0 	0 	$0 	$0

	B.  Required Activities

1)  Initial requirements a, c

    a)  Initial stack test (PM, dioxins/furans, opacity, HCl, Pb, Hg, SO2)

    b)  Establish and teach operato qualification course

    c)  Obtain operator qualification

    d)  Establish operating parameters (maximum and minimum)

    e)  Continuous parameter monitoring (including by-pass stack) initial costs	16

64

72

160

9 e

	1

1

1

1

1	16

64

72

160

9 	0a

0a

0a

0a

0a	0

0

0

0

0	0

0

0

0

0	0

0

0

0

0	$0

$0

$0

$0

$0	0

0

0

Included in 3B(a)

0

	0

0

0

0

0	$0

$0

$0

$0

$0	$0

$0

$0

$0

$0

2)  Periodic requirements

    a)  Annual stack test and test report (PM, HCl, and Opacity)

    b)  Annual refresher operator training course

    c)  Annual review of site-specific information

    d)  Continuous parameter monitoring (including by-pass stack) annual costs

12

12

8

83

1

1

1

 1

12

12

8

 83

97g

97g

97g

97g

1,164

1,164

776

8,051

58.2

58.2

38.8

402.55

116.4

116.4

77.6

805.1

$113,374.18

$113,374.18

$75,582.79

 $784,171.42

125

0

0

0

12,125

0

0

0

$0

$0

$0

$211h

$1,212,500

$0

$0

$20,467

	C.  Create Information	Included in 3B

D.  Gather Information	Included in 3E

E.  Report Preparation

1)  Control plan

2)  Notification of final compliance

3)  Report of initial performance test

4)  Siting analysis for new units onl (established values for site-specific operating parameters

5)  Waste management plan	40

4

8

8

160	 1

1

1

1

1	40

4

8

8

160	0

0

0

0

0	 0

 0

0

0

0	0

0

0

0

0	0

0

0

0

0	$0

$0

$0

$0

$0	0

0

50

0

0	0

 0

0

0

0	 $0

$0

$0

$0

$0	$0

$0

$0

$0

$0

6)  Annual Report: g

	a)  Site specific operating parameters	8 	1 	8 	97	776	38.8	77.6 $75,582.79	0 	0	$0 	$0

	b)  Emissions/parameter exceedances and malfunctions 	Included in 3E 10

c)  Results of stack tests conducted during the year	Included in 3B

d)  Statement of no exceedances 	8 	1 	8	97	776	38.8	77.6	$75,582.79	0  0 	$0 	$0

	e)  Documentation of use of by-pass stack	Included in 6B

f)  Documentation for periods when all qualified operators were unavailable for more than 8 hours	8 	1 	8 	97	776	38.8	77.6	$75,582.79	0 	0 	$0 	$0

7)  Status report for operators that are off-site for more than 2 weeks i	8 	1 	8 	10	80	4	8	$7,792.04	0 	0	$0 	$0

8)  Corrective action summary for operator that are off-site for more than 2 weeks i	8	2	16	10	160	8	16	$15,584.08	0	0	$0	$0

9)  Qualified operator deviation notification of resumed operation	8 	1  8	10	80 	4	8	$7,792.04	0 	0 	$0 	$0

10)  Semiannual report of emissions/parameter exceedances j	24 	1 	 24  10	240	12	24	$23,376.12	0 	0 	$0 	$0

4.  Recordkeeping Requirements

	A.  Read Instructions	Included in 3A

	B.  Plan Activities	Included in 3B

C.  Implement Activities	Included in 3B

D.  Develop Record System	N/A

E.  Record Information

1)  Records of operating parameters	Included in 3B

	2)  Records of periods for which minimum amount of data on operating parameters were not obtained	0.5	52	26	10	260	13	26	$25,324.13	0	0	$0	$0

3)  Records of malfunction of the unit	1.5 	1 	1.5 	10	15	0.75	1.5 $1,461	0 	0 	$0 	$0

4)  Records of exceedances of the operating parameters	1.5 	1 	1.5 	10 15	0.75	1.5	$1,461	0 	0 	$0 	$0

5)  Records of stack tests	Included in 3E

	6)  Records of persons who have reviewed operating procedures	1	1	1	97 97	4.85	9.7	$9,447.85	0	0	$0	$0

7)  Records of persons who have completed operator training	1 	1 	1 	97 97 	4.85	9.7	$9,447.85	0 	0 	$0 	$0

8)  Records of persons who meet operator qualification criteria	1	1	1	97 97	4.85	9.7	$9,447.85	0	0	$0

	9)  Records of monitoring device calibration	Included in 3B

10) Records of site-specific documentation	24 	1 	24 	97	2,.328	116.4 232.8	$226,748.36	0 	0 	$0 	$0

	F.  Personnel Training	Included in 3B

G.  Time for Audits	N/A

	TOTAL:

16,952	847.65	1,695.2	$1,651,133.28

12,125

$1,232,967

	Labor Hours	 Contractor Labor Hours	Total Hours	Labor Cost Contractor/Non-Labor Cost	Total Cost

	Summary of Respondent Burden

Annual Capital/Startup Costs

O & M Summary	19,494.8	12,125	31,619.8	$1,651,133.28	$1,232,967

$0

$20,467	$2,884,100.3$0

$20,467

ASSUMPTIONS:

a.  The average number of respondents per year over the three-year period of the renewal is 97.

b.  Assume that all tasks are to be performed by managerial, technical and clerical personnel.  This ICR uses the following labor rates: $100.99 for Managerial labor, $87.97 for Technical labor and $43.81 for Clerical labor.  These rates are from the United States Department of Labor Bureau of Labor Statistics, December 2005, “Table 2. Civilian Workers, by occupational and industry group.  The rates have been increased by 110% to account for the benefit packages available to those employed by private industry.  We also included contractors at $100.  The labor rate was also taken from the above occupational and industry group under Blue-Collar occupation that covers Machine operators, and took the rates from column 1, “Total compensation.”

c.  This activity is based on a one-time cost only.

d.  Cost incurred by a facility regardless of the number of affected units at the plant.

e.  Based on the “Revised Testing and Monitoring Options and Costs for medical Waste Incinerators (MWIs) - Methodology and Assumptions (A-91-61,IV-B-66), the assumption is that ($300 will be for planning + $500 for selection)/$89.94 per hour = 9 hours.

f.  Total capital cost of parameter monitoring for wet scrubbers minus costs for planning and selecting equipment equals: $18,786 - $800 = $17,986.  Based on 0.11746 capital recovery factor, 10% interest rate and 20 year lifetime of the units = $2,113 with a 1.06 cost adjustment = $2,240.

g.  Respondents make one combined annual report per year.

h.  Based on memorandum titled "Revised Testing and Monitoring Options and Costs for Medical Waste Incinerators (MWI's) - Methodology and Assumptions [A-91-61, IV-B-66], the respondents spend 83 hours for reporting; operation and maintenance costs - $1,693 x 0.11746 = $199; $199 x 1.06 cost adjustment = $211.

i.  Assume that 10 percent of the facilities would not have a qualified operator available for more than two weeks at least once a year.  Assume that this required only two corrective action summaries.

j.  Assume that 10 percent of the facilities would have an exceedance during the year.

k.  Assume thtat the average cost for contractor is $100.00 per hour.

TABLE 2:  Annual EPA Burden - Emission Guidelines for Commercial and Industrial Solid Waste Incineration Units (40 CFR Part 60, Subpart DDDD)

BURDEN ITEMS	(A)

Hours Per Occurrences	(B)

 Number of Occurrence Per Year a	(C)

Tech Hours Per Year @ $42.45

(C = A x B) b	(D)

Management Hours Per Year @ $57..20

(D = C x 0.05) b	(E)

Clerical Hours Per Year @ $22.96

(E = C x 0.1) b	(F)

Cost Per Year

1.	Applications	N/A

	2.	Read and Understand Rule Requirements 	16	0	0	0	0	$0

3.	Required Activities

Report Reviews

1)  Review control plan 	8	0	0	0	0	$0

2)  Review notification of final compliance 	8	0	0	0	0	$0

3)  Review waste management plan 	8 	0	0	0	0	$0

4)  Review initial stack test report 	40	0	0	0	0	$0

5)  Review annual compliance report	8	97	776	38.8	77.6	$36,942.22

6)  Review semi-annual excess emission and parameter exceedance report 16	10	160	8	16	$7,616.96

7)  Review status reports and corrective action summary for operators off-site	4 	10	40	2	4	$1,904.24

4.

Optional Activities

1)  Observing Compliance Tests	48	10	480	24	48	$22,850.88

	 E.	Prepare annual summary report	4	50	200	10	20	$9,521.2

5.	Travel expenses: (10 person x 30 hours per year/8 hours per day x $75 per diem) + (10 x $600 per round trip)

	$8,812.50

	TOTAL

1,656	82.8	165.6	$87,648

Assumptions:

a.  Costs are based on the following rates obtained from the Office of Personnel Management (OPM) “2006 General Schedule” which excludes locality rates of pay and multiplied by 1.6 to account for government overhead expenses: 1) Managerial at $57.20, 2) Technical at $42.45, and 3) Clerical at $22.96 per hour.  These rates are increased by 1.6 benefits multiplication factor to account for government overhead expenses.

b.  Assume that 10% of the facilities will have exceedance reports and operator off-site reports.

c.  Assume that each state will prepare an annual summary of progress for implementing the state plan.  One occurrence per year x 50 states = 50 occurrences.

d.  Assume that 10% of the compliance tests (annual or initial) are observed, and that it takes 48 hours each.

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[Federal Register: November 21, 2005 (Volume 70, Number 223)]
[Notices]
[Page 70110]
[DOCID:fr21no05-91]

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SECURITIES AND EXCHANGE COMMISSION

[File No. 500-1]

Allixon International Corp.; Order of Suspension of Trading

November 17, 2005.
    It appears to the Securities and Exchange Commission that the
public interest and the protection of investors require a suspension of
trading in the securities of Allixon International Corp. (``AXCP'').
The Commission is concerned that AXCP and/or certain of its
shareholders may have unjustifiably relied on Rule 504 of Regulation D
and/or provisions of Regulation S of the Securities Act of 1933
(``Securities Act'') in conducting an unlawful distribution of AXCP
securities that failed to comply with the resale restrictions of Rule
144 and/or Regulation S of the Securities Act. AXCP, a company that has
made no public filings with the Commission or the NASD, is quoted on
the Pink Sheets, under the symbol AXCP, and has been the subject of
spam e-mail touting the company's shares.
    The Commission is of the opinion that the public interest and the
protection of investors require a suspension of trading in the
securities of the above listed company. Therefore, it is ordered,
pursuant to Section 12(k) of the Securities Exchange Act of 1934, that
trading in the above listed company is suspended for the period from
9:30 a.m. e.s.t. November 17, 2005 through 11:59 p.m. e.s.t., on
December 1, 2005.

    By the Commission.
Jonathan G. Katz,
Secretary.
[FR Doc. 05-23079 Filed 11-17-05; 12:25 pm]

BILLING CODE 8010-01-P


[Federal Register Volume 84, Number 81 (Friday, April 26, 2019)]
[Rules and Regulations]
[Page 17754]
[FR Doc No: 2019-08403]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2019-0236]

Safety Zone; Pittsburgh Pirates Fireworks, Allegheny River,
Pittsburgh, PA

AGENCY: Coast Guard, DHS.

ACTION: Notice of enforcement of regulation.

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SUMMARY: The Coast Guard will enforce safety zones for the Pittsburgh
Pirates Fireworks on the Allegheny River, extending the entire width of
the river, from mile 0.2 to 0.9 in Pittsburgh, PA. The safety zones are
necessary to protect vessels transiting the area and event spectators
from the hazards associated with the Pittsburgh Pirates barge-based
firework displays following certain home games throughout the season.
During the enforcement period, entry into, transiting, or anchoring in
the safety zones is prohibited to all vessels not registered with the
sponsor as participants or official patrol vessels, unless specifically
authorized by the Captain of the Port Marine Safety Unit Pittsburgh
(COTP) or a designated representative.

DATES: The regulations in 33 CFR 165.801, Table 1, Line 1 will be
enforced from 8 p.m. through 11:59 p.m. on May 4, 2019, unless the
firework displays are postponed because of adverse weather, in which
case, this rule will be enforced within 48 hours of the scheduled date.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
notice of enforcement, call or email MST1 Jennifer Haggins, Marine
Safety Unit Pittsburgh, U.S. Coast Guard; telephone<PHONE_NUMBER>, email
[email protected].

SUPPLEMENTARY INFORMATION: The Coast Guard will enforce the safety
zones for the annual Pittsburgh Pirates Fireworks listed in 33 CFR
165.801, Table 1, line 1 from 8 p.m. through 11:59 p.m. on May 4, 2019.
Should inclement weather require rescheduling, the safety zone will be
effective following the game on a rain date to occur within 48 hours of
the scheduled date. Entry into the safety zone is prohibited to all
vessels not registered with the sponsor as participants or official
patrol vessels, unless authorized by the Captain of the Port Marine
Safety Unit Pittsburgh (COTP) or a designated representative. Persons
or vessels desiring to enter into or pass through the safety zone must
request permission from the COTP or a designated representative. If
permission is granted, all persons and vessels shall comply with the
instructions of the COTP or designated representative.
    This notice of enforcement is issued under authority of 33 CFR
165.801 and 5 U.S.C. 552(a). In addition to this notice of enforcement
in the Federal Register, the Coast Guard will provide the maritime
community with advance notification of these enforcement periods via
Local Notice to Mariners and updates via Marine Information Broadcasts.

    Dated: April 22, 2019.
A.W. Demo,
Commander, U.S. Coast Guard, Captain of the Port Marine Safety Unit
Pittsburgh.
[FR Doc. 2019-08403 Filed 4-25-19; 8:45 am]
BILLING CODE 9110-04-P