[Federal Register Volume 77, Number 164 (Thursday, August 23, 2012)]
[Notices]
[Pages 51027-51030]
[FR Doc No: 2012-20783]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0892]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Communicating Composite Scores 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, ``Communicating
Composite Scores in Direct-to-Consumer (DTC) Advertising.'' This study
is designed to explore how consumers understand and interpret composite
endpoint scores in DTC ads.

DATES: Submit written or electronic comments on the collection of
information by October 22, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<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.

Communicating Composite Scores in Direct-to-Consumer (DTC)
Advertising--(OMB Control Number 0910-NEW)

I. Regulatory Background

    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 903(b)(2)(c) of the Federal Food, Drug, and
Cosmetic Act (the FD&C Act) (21 U.S.C. 393(b)(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.

II. Composite Scores

    To market their products, pharmaceutical companies must demonstrate
to FDA the efficacy and safety of their drugs, typically through well-
controlled clinical trials (Refs. 1 and 2). In some cases, drug
efficacy can be measured by a single endpoint, such as high blood
pressure (Ref. 3). Often, however, efficacy is measured by multiple
endpoints that are sometimes combined into an overall score called a
composite score (Refs. 4 and 5). For example, nasal allergy relief is
measured by examining individual symptoms such as runny nose,
congestion, nasal itchiness, and sneezing. Each symptom is measured on
its own. An overall score is computed from the individual symptom
measurements; if a drug has a significantly better overall score than
the comparison group (e.g., placebo), it can be marketed for the relief
of allergy symptoms. However, although a drug may have a significantly
better score overall, it may not have a significantly better score on a
particular aspect (e.g., runny nose). Scientists and medical
professionals have had training to understand the difference between
composite score endpoints and single endpoints, but members of the
general public may not understand the difference.
    Given the frequency of DTC advertising, it is important to
determine whether consumers understand composite scores as they are
currently communicated and how best to communicate such scores to lay
audiences in general. Because most DTC prescription drug ads do not
explicitly state that they used composite scores to demonstrate
efficacy or they provide little explanation of how these scores are
calculated, it is also important to understand whether consumers

recognize how composite scores are used for measuring drug efficacy.
    Prior research on composite scores is scant. Therefore, in
September 2011, FDA conducted a focus group study to better understand
how consumers understand the concept of composite scores. Prior to the
focus group, few participants had heard the term ``composite score,''
none were aware of how the scores might be used in clinical trials, and
most participants had difficulty correctly interpreting efficacy
information that was based on composite scores. Once the moderator
explained composite scores to participants, some reassessed their
opinion of the advertised drug's effectiveness and said they thought
that the information on effectiveness was ``much less convincing,'' in
many cases because it was unclear whether the drug would work for a
particular symptom. As a result, some participants said they would want
a drug ad to include more detailed information on the effectiveness of
the drug on each component of the composite score. However, others felt
that the ads already provided enough information on effectiveness and
that adding more statistical details would make the ads more
complicated, thus decreasing the likelihood that consumers would read
them.
    The focus group findings suggest that research is required to
examine how the inclusion of increasingly detailed information affects
understanding of composite scores and influences perceptions of
efficacy. This is especially important given the many marketed
prescription drugs that are based on composite outcomes.
    We are aware of no quantitative research on best practices for
communicating composite score information to consumers. One related
area of research, communicating health-related information to
consumers, offers two practical recommendations that are particularly
relevant to communicating composite scores in DTC advertisements.
First, because less-numerate and less-literate consumers may not
understand the information as well, examining differences in
comprehension of composite scores by numeracy- and literacy-relevant
demographic characteristics such as education level and age is
important (Refs. 6 and 7). Second, although the literature tends to
suggest limiting the amount of information presented in advertisements
(Refs. 7 to 9), examining the amount of detail that best facilitates
comprehension of composite scores is warranted.

III. Research Purpose

    Given the lack of research on consumer understanding of composite
scores and how to best present this information in DTC advertisements,
the main goal of the current research is to evaluate how consumers
interpret and respond to DTC prescription drug advertising that
includes benefit information based on composite scores. Specifically,
this research will explore:
    1. Whether consumers are aware of how efficacy is measured for
specific drugs;
    2. How well consumers comprehend the concept of composite scores;
    3. Whether exposure to DTC advertisements with composite endpoint
benefit information influences consumers' perceptions of a drug's
efficacy and risk; and
    4. Different methods for presenting composite endpoint benefit
information in DTC ads to maximize consumer comprehension and informed
decisionmaking.
    The research will be conducted in two studies. Using a general
population sample of adults, the first study will be a web-based
survey, with a pre-post design, that will explore consumers' awareness
of how efficacy is measured for drugs and consumers' comprehension of
the concept of composite scores. The second study will be a randomized,
controlled study conducted online using a web-based panel to examine
whether exposure to DTC advertisements with composite endpoint benefit
information influences consumers' perceptions of a drug's efficacy and
risk, and how DTC advertisements can best deliver composite endpoint
benefit information to maximize consumer comprehension and informed
decisionmaking. Questionnaires for both studies are available upon
request.

IV. Design Overview

    Study 1. In this phase, individuals in a general population sample
of 1,600 adults of varying education levels will answer an Internet
survey designed to explore whether consumers recognize composite scores
in DTC ads and their understanding of composite endpoint scores. The
survey will be conducted with a probability-based consumer panel of
U.S. adults.
    As part of the survey, participants will view a print ad that
contains claims based on composite scores and respond to questions
about the ad to assess whether they recognized that composite scores
were used. Other outcomes will include ad comprehension, perceived
efficacy, and perceived risk as they relate to their understanding of
composite endpoint scores. We will also examine whether and in what
ways participants' perceived efficacy and perceived risk change after
they are given a definition and examples of composite scores. Questions
will also explore consumers' understanding of how the effectiveness of
drugs is measured in general.
    This exploratory survey will not be used to test specific
hypotheses. However, we will explore the differences in responses to
the ad before and after information about composite scores is provided.
We will also examine differences in the comprehension of the composite
score concept and in the features of the ad by education level and age
because literature suggests that less-educated and older consumers may
not understand this type of information as well (Ref. 6).
    Study 2. Unlike Study 1, Study 2 will be a randomized, controlled
study. Study 2 will examine different ways to present the information
that arises from a composite endpoint and different ways to explain the
concept of a composite score (an educational intervention). Outcome
measures will include consumers' awareness and comprehension of the
composite score concept, perceived drug efficacy, and risk recall.
Participants will be randomly assigned to experimental arms in a 3 x 2
design as shown in table 1.

                                                            Table 1--Study Design for Study 2
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                                                                Information presentation
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     Educational intervention              General indication                 List of symptoms               Composite definition             Total
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Absent............................  Arm 1 (n=267)...................  Arm 2 (n=267)..................  Arm 3 (n=267)..................               801
Present...........................  Arm 4 (n=267)...................  Arm 5 (n=267)..................  Arm 6 (n=267)..................               801
                                   ---------------------------------------------------------------------------------------------------------------------

    Total.........................  534.............................  534............................  534............................             1,602
--------------------------------------------------------------------------------------------------------------------------------------------------------

    This study will manipulate two variables: Three types of
information presentations and the presence or absence of an educational
intervention. In terms of information presentation, there are many
aspects of composite endpoint scores that could be communicated and one
research project cannot test them all. In this study, we have chosen to
examine three different information presentations that may or may not
help consumers understand the composite score concept. These different
information presentations were chosen based on a review of the
literature and a review of past DTC submissions.
    The three different information presentations are described as
follows:
    General Indication. The first information presentation is the
indication of the product. In this condition, participants will see the
drug indication but will not see any explicit statement that the drug's
benefits are based on a composite endpoint. This is a common way that
composite scores are currently communicated. An example of this
presentation is: ``Drug A treats and helps prevent seasonal nasal
allergy symptoms.''
    List of Symptoms. The next information presentation will include
the drug indication and all of the symptoms that are used to make up
the composite score. This condition, like the general indication
condition, will not include an explicit statement referencing composite
scores. This is also a common way that composite scores are currently
communicated. An example of this presentation is: ``Drug A treats and
helps prevent seasonal nasal allergy symptoms: Congestion, runny nose,
nasal stuffiness, nasal itching, and sneezing.''
    Composite Definition. The final information presentation will
present the indication, describe that the drug's benefits are based on
a composite endpoint, and explicitly define a composite score. To our
knowledge, this would be a new way to communicate composite scores. An
example of this presentation is: ``Drug A treats and helps prevent
seasonal nasal allergy symptoms. Drug A's effectiveness is based on a
composite score. A composite score is a single measure of how well a
drug works based on a combination of factors. Drug A may not be as
effective in addressing each factor individually.''
    We will also manipulate whether or not participants see a specific
educational intervention. This intervention was developed from prior
focus groups (OMB Control No. 0910-0677) where it was found to resonate
with participants. It will feature the decathlon as an educational
example of a composite score. For example, ``Drug A's effectiveness is
based on a composite score. A composite score is like a decathlon. In
that event, athletes compete in 10 events, such as the long jump, the
shot put, and the 50 yard dash. An athlete may not win all events, but
if he or she wins some and performs well enough in others, he or she
may be the winner based on a combination of scores for each event.''
    We will test whether the educational intervention, the information
presentation, and the interaction of the two affect outcomes such as
consumers' awareness and comprehension of the composite score concept;
perceived drug efficacy; and risk recall. We will test whether numeracy
and literacy moderates any significant relations.
    The sample for the second study will include approximately 1,602
participants who have been diagnosed with seasonal allergies. The
protocol will take place via the Internet. Participants will be
randomly assigned to view one print ad for a fictitious prescription
drug that treats seasonal allergies and will answer questions about it.
The entire process is expected to take no longer than 20 minutes. This
will be a one-time (rather than annual) collection of information.
    FDA estimates the burden of this collection of information as
follows:

                                                     Table 2--Estimated Annual Reporting Burden \1\
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                                                                 Number of
                  Activity                       Number of     responses per   Total annual           Average burden per response           Total hours
                                                respondents     respondent       responses
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Screeners, Study 1..........................           3,200               1           3,200  0.03 (2 minutes)..........................              96
Pretest, Study 1............................             200               1             200  0.33 (20 minutes).........................              66
Main Survey, Study 1........................           1,600               1           1,600  0.33 (20 minutes).........................             528
Screeners, Study 2..........................           3,400               1           3,400  0.03 (2 minutes)..........................             102
Pretest, Study 2............................             600               1             600  0.33 (20 minutes).........................             198
Main Study, Study 2.........................           1,602               1           1,602  0.33 (20 minutes).........................             529
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................          10,602  ..............  ..............  ..........................................           1,519
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    The total respondent sample for this data collection is 10,602. For
Study 1, we will sample 200 respondents for pretesting and 1,600
respondents for the full study. For Study 2, we will sample 600
respondents for pretesting and 1,602 participants for the full study.
We estimate the response burden to be no more than 20 minutes, for a
total burden, including screeners, of 1,519 hours.

V. References

    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. (FDA has verified the Web
site addresses, but we are not responsible for any subsequent changes
to the Web sites after this document publishes in the Federal
Register.)
    1. Lipsky, M.S. and L.K. Sharp, ``From Idea to Market: The Drug
Approval Process,'' Journal of the American Board of Family
Practitioners, vol. 14(5), pp. 362-367, 2001.
    2. ``Guidance for Industry: Postmarketing Studies and Clinical
Trials--Implementation of Section 505(o)(3) of the Federal Food, Drug,
and Cosmetic Act,'' (http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172001.pdf), 2008.
    3. Rutan, G.H., R.H. McDonald, and L.H. Kuller, ``A Historical
Perspective of Elevated Systolic vs. Diastolic Blood Pressure From an
Epidemiological and Clinical Trial Viewpoint,'' Journal of Clinical
Epidemiology, vol. 42(7), pp. 663-673, 1989.
    4. Agency for Healthcare Research and Quality, ``Combining Measures
Into Composite or Summary Scores,'' (http://www.ahrq.gov/qual/perfmeasguide/), 2012.
    5. American Medical Association, ``Measures Development,
Methodology, and Oversight Advisory Committee: Recommendations to PCPI
Work Groups on Composite Measures,'' (http://www.ama-assn.org/resources/doc/cqi/composite-measures-framework.pdf), 2010.
    6. Fagerlin, A. and E. Peters, ``Quantitative Information,'' In: B.
Fishoff, N.T. Brewer, and J.S. Downs (Eds.), Communicating Risks and
Benefits: An Evidence-Based User Guide, Food and Drug Administration,
U.S. Department of Health and Human Services, (http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/ucm268078.htm), 2011.
    7. Peters, E., D. Vastfijall, P. Slovic, et al., ``Numeracy and
Decision Making,'' Psychological Science, vol. 17(5), pp. 407-413,
2006.
    8. Gurmankin, A. D., J. Baron, and K. Armstrong, ``The Effects of
Numerical Statements of Risk on Trust and Comfort With Hypothetical
Physician Risk Communication,'' Medical Decision Making, vol. 24(3),
pp. 265-271, 2004.
    9. Edwards, A., R. Thomas, R. Williams, et al., ``Presenting Risk
Information to People With Diabetes: Evaluating Effects and Preferences
for Different Formats by a Web-Based Randomized Controlled Trial,''
Patient Education Counseling, vol. 63, pp. 336-349, 2006.

    Dated: August 17, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-20783 Filed 8-22-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: May 2, 2006 (Volume 71, Number 84)]
[Notices]
[Page 25829-25830]
[DOCID:fr02my06-52]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. CP04-400-001]

Golden Pass Pipeline LP; Notice of Application

April 26, 2006.
    Take notice that on March 31, 2006, Golden Pass Pipeline LP (GPPL)
filed in Docket No. CP04-400-001 an application seeking to amend the
certificate of public convenience and necessity issued July 6, 2005, in
Docket No. CP04-400-000. That certificate issued pursuant to section
7(c) of the NGA and part 157, subpart A of the Commission's
Regulations, authorized construction and operation of facilities to
transport natural gas originating from liquefied natural gas (LNG)
receiving terminal to be located approximately 10 miles south of Port
Arthur, Texas, and two miles northeast of the town of Sabine Pass,
Texas.
    GPPL requests authorization to make certain variations in the
design and routing of the proposed pipeline that would reduce its
overall construction footprint. The new design component would replace
the looped segment of 43 miles of two 36-inch diameter pipelines with a
single 42-inch diameter pipeline from Golden Pass LNG Terminal to the
AEP Texoma interconnection. The reroute component would relocate the
route resulting in an approximately ten mile reduction in length of the
pipeline.
    This application is on file with the Commission and open to public
inspection. This filing is available for review at the Commission in
the Public Reference Room or may be viewed on the Commission's Web site
at http://www.ferc.gov using the ``eLibrary'' link. Enter the docket

number excluding the last three digits in the docket number field to
access the document. For assistance, please contact FERC Online Support
at<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for
TTY, contact<PHONE_NUMBER>. Any initial questions regarding these
applications should be directed to Mrs. Gina M. Dickerson, 17001
Northchase Drive, Houston, Texas, 77060, at phone number (281) 654-
4816.
    There are two ways to become involved in the Commission's review of

this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the below listed comment date, file with the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit 14 copies of filings made with the Commission and must mail a
copy to the applicant and to every other party in the proceeding. Only
parties to the proceeding can ask for court review of Commission orders
in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as possible, an original and
two copies of comments in support of or in opposition to this project.
The Commission will consider these comments in determining the
appropriate action to be taken, but the filing of a comment alone will
not serve to make the filer a party to the proceeding. The Commission's
rules require that persons filing comments in opposition to the project
provide copies of their protests only to the party or parties directly
involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commenters will not be required to serve copies of filed
documents on all other parties. However, the non-party commenters will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    Motions to intervene, protests and comments may be filed
electronically via the internet in lieu of paper; see, 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.
    Comment Date: 5 p.m. eastern time on May 17, 2006.

Magalie R. Salas,
Secretary.
[FR Doc. E6-6581 Filed 5-1-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: July 24, 2009 (Volume 74, Number 141)]
[Notices]
[Page 36696-36698]
[DOCID:fr24jy09-66]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2009-0253; FRL-8934-5]

Agency Information Collection Activities: Proposed Collection;
Comment Request; Emission Guidelines for Large Municipal Waste
Combustors Constructed on or Before September 20, 1994; EPA ICR No.
1847.05, OMB Control No. 2060-0390

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). The ICR is
scheduled to expire on November 30, 2009. 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 September 22, 2009.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-HQ-
OAR-2009-0253 by one of the following methods:
     http://www.regulations.gov: Follow the online instructions
for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: ICR Renewal (2009)--Emission Guidelines for Large
Municipal Waste Combustors

Constructed on or before September 20, 1994 (40 CFR part 60, subpart
Cb), Environmental Protection Agency, Mailcode: 2822, 1200 Pennsylvania
Ave., NW., Washington, DC 20460.
     Hand Delivery: EPA Docket Center, Public Reading Room, EPA
West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC
20004. 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-OAR-
2009-0253. 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 that you
consider to be CBI or otherwise protected through http://
www.regulations.gov or e-mail. The 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 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 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 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. For additional information about EPA's public
docket visit the EPA Docket Center homepage at http://www.epa.gov/
epahome/dockets.htm.

FOR FURTHER INFORMATION CONTACT: Walt Stevenson, Sector Policies and
Programs Division, Office of Air Quality Planning and Standards, Mail
Code D243-01, Environmental Protection Agency, 109 T.W. Alexander
Drive, Research Triangle Park, NC 27711; telephone number: 919-541-
5264; fax number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

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

    EPA has established a public docket for the ICR under Docket ID No.
EPA-HQ-OAR-2009-0253, which is available for online viewing at http://
www.regulations.gov, or in person viewing at the Docket in the EPA
Docket Center (EPA/DC), EPA West Building, Room 3334, 1301 Constitution
Ave., NW., Washington, DC. The EPA/DC 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 Air Docket is<PHONE_NUMBER>.
    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. Once
in the system, select ``search,'' then key in the docket ID number
identified in this document.

What Information Is EPA Particularly Interested In?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    1. Evaluate whether the collection of information is necessary for
the proper performance of the functions of the Agency, including
whether the information will have practical utility.
    2. Evaluate the accuracy of the Agency's estimate of the burden of
the collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. 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
small businesses on examples of specific additional efforts that EPA
could make to reduce the paperwork burden for any small businesses that
are affected by this collection.

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

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Offer alternative ways to improve the collection activity.
    6. Make sure to submit your comments by the deadline identified
under DATES.
    7. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

What Information Collection Activity or ICR Does This Apply to?

    Affected Entities: Entities potentially affected by this action are
large municipal waste combustors (large MWCs). The SIC codes (and
associated North American Industry Classification System (NAICS) codes)
for possible respondents affected by the standards are listed in the
table below.

------------------------------------------------------------------------
            Standard                   SIC codes          NAICS codes
------------------------------------------------------------------------
40 CFR part 60, subpart Cb......  9511, Air and       92411, Air and
                                   Water Resource      Water Resource
                                   and Solid Waste     and Solid Waste
                                   Management.         Management.
40 CFR part 62, subpart FFF.....  4953, Refuse        562213, Solid
                                   Systems.            Waste Combustors
                                                       and Incinerators.
------------------------------------------------------------------------

    Title: Emission Guidelines for Large Municipal Waste Combustors
Constructed on or before September 20, 1994 (40 CFR part 60, subpart
Cb).
    ICR numbers: EPA ICR No. 1847.05, OMB Control No. 2060-0390.

    ICR status: Currently, the ICR is scheduled to expire on November
30, 2009. 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, and 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: The data collection ICR is a renewal of current data
collection and reporting requirement for large MWCs subject to 40 CFR
part 60, subpart Cb emission guidelines. The subpart Cb guidelines are
maximum achievable control technology (MACT) based standards that were
adopted in 1995 and were fully implemented by year 2000. The data
collected by the ICR are intended to monitor the compliance status of
large MWCs subject to these MACT standards. The data collection is a
mandatory requirement (Clean Air Act section 114(a)(1)).
    Burden Statement: The annual reporting and recordkeeping burden for
this collection of information includes: (1) The burden for large MWCs
subject to the Federal plan implementing subpart Cb guidelines; (2) the
burden for large MWCs subject to approved State plans implementing
subpart Cb guidelines; and (3) the burden for State air pollution
control offices (designated administrators) to enforce State plans
implementing subpart Cb guidelines. The hourly burden estimate for
large MWCs subject to the Federal plan level is estimated to average
2,584 hours per year per MWC unit (or 5,514 hours per year per MWC
plant), and the burden estimate for large MWCs subject to approved
State plans is estimated to average 2,403 hours per unit (or 6,291
hours per year per MWC plant). For designated administrators, the
burden is estimated to average 21 hours per year per MWC unit (or 55
hours per plant).
    For MWC owners and operators, burden means the total time, effort,
or financial resources expended by persons to generate, maintain,
retain, or disclose or provide information to the designated
administrator (or EPA). 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.
    For delegated administrators (State air pollution control offices),
burden means the total time, effort, or financial resources expended to
review information provided by MWC owners and operators to comply with
the emission guidelines through State plan. This includes the time
needed to review semiannual and annual compliance reports; develop and
utilize technology and systems for the purposes of collecting,
validating, and verifying information, processing and maintaining
information, and providing information; train personnel to review the
collection of information; and transmit or otherwise disclose the
information.
    The ICR provides a detailed explanation of the Agency's estimate,
which is only briefly summarized as follows:
    Estimated total number of potential respondents: The number of
respondents for large MWCs subject to the Federal plan is estimated to
be nine MWC owners and operators; and the number of respondents for
large MWCs subject to approved State plans is estimated to be 55 MWC
owners and operators. For designated administrators, the total number
of respondents is estimated to be 18 designated administrators.
Therefore, the total number of respondents is 82, which comprises 31
privately owned MWC plants, 32 publicly owned MWC plants, and 18
designated administrators.
    Frequency of response: Annual, semiannual.
    Estimated total average number of responses for each respondent:
The overall average number of responses is 229, as follows. For
privately owned MWC plants, the total number of annual responses is 78;
for publicly owned MWC plants, the total number of annual responses is
74; and for designated administrators, the total number of annual
responses is 77.
    Estimated total annual burden hours: The estimated total annual
burden hours is 394,954, as follows. For privately owned large MWC
plants, the total annual burden hours are 190,954. For publicly owned
large MWC plants, the total annual burden hours are 200,964. For
designated administrators, the total annual burden hours are 3,036.
    Estimated total annual costs: The estimated total annual costs are
$50,588,150, as follows. This includes an estimated base burden cost of
$49,032,950 and additional capital investment/maintenance/operational
costs of $1,555,200.

Are There Changes in the Estimates From the Last Approval?

    Yes. First, for large MWCs subject to the Federal plan the current
ICR the burden estimate (2006 to 2009) is 38,417 hours per year. For
the ICR renewal (2009 to 2012) the burden estimate for large MWCs
subject to the Federal plan increases to 46,513 hours per year. This
increase reflects EPA's updating of burden based on more current
inventory and performance data from large MWCs.
    Additionally, the ICR includes the burden estimates for large MWCs
subject to approved State plans and for designated administrators
implementing approved State plans. These burden estimates were not
included in the previous ICR. The combined annual labor burden for
large MWCs subject to the Federal plan, large MWCs subject to State
plans, and burden for designated agencies implementing these
regulations is 395,330 hours per year and $49,032,950 per year for
labor costs. The combined annual non-labor costs for MWCs subject to
the Federal plan and State plans are $1,555,200.

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
person listed under FOR FURTHER INFORMATION CONTACT.

    Dated: July 16, 2009.
Penny E. Lassiter,
Acting Director, Sector Policies and Programs Division.
[FR Doc. E9-17718 Filed 7-23-09; 8:45 am]

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