[Federal Register: January 13, 2006 (Volume 71, Number 9)]
[Notices]
[Page 2209-2210]
[DOCID:fr13ja06-69]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP96-312-154]

Tennessee Gas Pipeline Company; Notice of Negotiated Rate Filing

January 6, 2006.
    Take notice that on December 30, 2005, Tennessee Gas Pipeline
Company (Tennessee), tendered for filing and approval an amendment to
an existing negotiated rate agreement between Tennessee and Nicor Gas.
Tennessee requests that the Commission accept and approve the subject
amendment to be effective January 1, 2006.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date need not serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call

(866) 208-3676 (toll free). For TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
[FR Doc. E6-298 Filed 1-12-06; 8:45 am]

BILLING CODE 6717-01-P


            Supporting Statement for a Request for OMB Review under
                          the Paperwork Reduction Act

                                    PART A

1.  IDENTIFICATION OF THE INFORMATION COLLECTION

	1(a)	Title and Number of the Information Collection

	Title:	Survey of the Public and Commercial Building Industry

		EPA ICR No.: 2494.01		OMB Control No.: 2070-NEW

	1(b) 	Short Characterization

EPA's Office of Pollution Prevention and Toxics (OPPT) is investigating whether renovation, repair and painting (RRP) activities in public and commercial buildings (P&CBs) create lead-based paint hazards.  If EPA finds that these activities create lead-based paint hazards, the Agency will consider the types of regulatory action that might be appropriate to control the resulting exposures to lead.  EPA seeks to survey construction contractors, property managers and lessors, and building occupants about RRP activities in P&CBs.

The information collected through the survey will allow OPPT to predict a baseline for the incidence of different types of RRP activities that disturb lead-based paint in P&CBs, the methods that are used to conduct these activities, the work practices that are used to contain and clean the resulting dust, and the characteristics of the buildings.  OPPT will use this information to estimate the resulting exposures to lead dust, which will inform Agency decision making about the need for and scope of potential regulatory or other actions to reduce exposures to lead dust from RRP activities in P&CBs.  If EPA determines that a regulation is needed, the Agency will use this data to assess the incremental benefits and costs of potential options to reduce such exposures.  If this survey is not conducted EPA would have to rely on assumptions, anecdotal information, or information collected from convenience samples, rather than calculating nationally representative parameter estimates from a probability sample.

The primary objectives of the Public and Commercial Building Industry survey include: (1) gathering information on building and activity patterns that may affect exposures to lead dust from RRP activities in P&CBs; (2) determining the number of firms that perform RRP activities in P&CBs, (3) determining the types and numbers of RRP activities that are performed, (4) determining the extent to which various work practices that disturb painted surfaces are currently being used in RRP jobs in P&CBs, and (5) determining the extent to which various work practices for the containment and cleanup of lead dust are currently being used in RRP jobs performed in P&CBs.

The survey will collect information from three different groups:  (A) establishments that perform RRP activities in P&CBs for compensation on a contract basis, hereafter referred to as contractors; (B) lessors and managers of P&CBs; and (C) building occupants of P&CBs (both owners and tenants) who may use their own staff to perform RRP activities.  There will be separate questionnaires for each group.  Information will be collected using telephone and online survey instruments.

The information collection will be a one-time data collection.  Participation will be voluntary.  Establishments will be selected using a stratified random sampling method.  EPA plans to have 402 respondents complete a questionnaire.  Because of the difficulty of finding the population of the establishments engaged in RRP activities in P&CBs, EPA anticipates having to contact approximately 8,485 entities and ask them a few, brief screening questions.  All of these entities are counted as respondents for the purpose of calculating the burden of the survey.

Information on whether an establishment performs RRP activities in P&CBs is not available from any readily accessible source.  Therefore, it is not feasible to design a random sampling method for the survey without contacting a large number of establishments and asking them a few brief questions in the screening portion of the questionnaire.  It is worth noting that the information collected from the estimated 8,485 establishments that will not complete the full questionnaire is still very important to EPA.  Specifically, together with the information collected from the 402 respondents expected to complete the full survey it will provide a basis for estimating the population of establishments engaged in RRP activities in P&CBs.  The questionnaire has been designed to quickly screen out respondents who do not perform RRP activities in P&CBs, in order to reduce the burden of locating eligible respondents.

EPA estimates that the screening portion of the survey will take about 3 minutes to complete on average.  For respondents completing the contractor questionnaire, it is estimated that the remaining portion of the survey will require about 30 minutes on average.  For respondents completing the property lessor/manager or building occupant questionnaires, the remaining portion of the survey is estimated to require about 5 minutes on average.  EPA estimates that the roughly 8,485 survey respondents will incur a total burden of 564 hours for both the screening questions and the full survey.  The total cost to respondents of this one-time collection is estimated to be $34,103.  The cost to the agency is estimated to be approximately $710,000.

2.	NEED AND USE FOR THE COLLECTION

	2(a)	Need and Authority for the Collection

	Title IV of TSCA, 15 U.S.C. 2681 et seq. (see Attachment 1), was enacted to assist the Federal Government in reducing lead exposures, particularly those resulting from lead-based paint (LBP). Section 402(c)(3) of TSCA specifically requires EPA to revise its Lead-Based Paint Activities regulations, promulgated under TSCA section 402(a), to apply to those renovation and remodeling activities in target housing, public buildings constructed before 1978, and commercial buildings that create lead-based paint hazards. In April 2008, EPA promulgated the RRP rule (40 CFR part 745) under TSCA section 402(c)(3). The RRP rule covers renovation, repair, and painting activities in target housing (which is most pre-1978 housing) and child-occupied facilities (which includes a subset of P&CBs in which young children spend a significant amount of time).

Several lawsuits were filed against EPA asserting, among other things, that the Agency violated TSCA section 402(c)(3) by failing to address renovation activities in P&CBs.  These lawsuits (brought by environmental and children's health advocacy groups as well as a homebuilders association) were consolidated in the Circuit Court of Appeals for the District of Columbia Circuit. EPA engaged in collective settlement negotiations with all the parties and on August 24, 2009, EPA entered into an agreement with environmental and children's health advocacy groups in settlement of their lawsuits.  Shortly thereafter the homebuilders association voluntarily dismissed its challenge to the rule.  As part of this settlement agreement, EPA agreed to commence rulemaking to address renovations in P&CBs (other than child-occupied facilities) to the extent such renovations create LBP hazards.  As an initial step, EPA issued an ANPRM in the Federal Register on renovations in public and commercial buildings on May 6, 2010.

The settlement agreement has been amended and modified several times (primarily to extend deadlines), with the most recent amendment having been entered into by the parties on September 7, 2012. Under the terms of the amended settlement agreement, the date by which EPA has agreed to either sign a proposed rule covering RRP activities in P&CBs, or determine that these activities do not create LBP hazards, is July 1, 2015. If EPA publishes a proposed rule in the Federal Register, EPA agreed to take final action on or before the date 18 months after the proposed rule has published.

In addition, as part of the agreement EPA held a public meeting on June 23, 2013, and offered an opportunity for stakeholders and other interested members of the public to provide data and other information that EPA may use in making its regulatory determinations.

The purpose of this ICR is to fill some of the key data gaps for EPA's exposure assessment and for its economic analysis of potential options to reduce exposure to lead dust from RRP activities in P&CBs.  Without the survey, the exposure assessment and the economic analysis would need to rely on assumptions, anecdotal information, or information collected from convenience samples, rather than calculating nationally representative parameter estimates from a probability sample.  The survey results are expected to be more representative than these alternatives.

	2(b)	Practical Utility and Users of the Data

	This survey will allow EPA to produce statistically valid estimates for the population of RRP firms and jobs that disturb paint in P&CBs, and the work practices that are used.  EPA will use the data collected though this one-time survey as part of its investigation.  Without the proposed information collection, these estimates would have to be derived from assumptions, anecdotal information, or information collected from convenience samples, rather than calculating nationally representative parameter estimates from a probability sample.

The primary purposes of this survey include gathering information on building and activity patterns that may affect exposures to lead dust from RRP activities in P&CBs; estimating the baseline usage of particular work practices, and how this usage varies with the type of RRP job; determining the number of firms that perform RRP activities in P&CBs; and determining the types and numbers of RRP activities that are performed.

Secondly, the survey will attempt to collect information on how the proportion of jobs that use particular practices differs between different types of firms.  In addition to baseline work practice data, the survey will collect information on the number of contractors that are already trained and certified under the existing RRP Program.

3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION
	CRITERIA

	3(a)	Non-Duplication

To the best of EPA's knowledge, the data to be collected through this survey is not available elsewhere.  EPA has investigated various sources of data on RRP firms and practices, including other surveys, trade association literature, academic studies, government reports, and information provided to EPA through public comments.  In general, other sources of information on RRP either do not address the issues where EPA needs data; are based on judgments rather than a comprehensive and rigorous collection of information; lack the specificity and level of detail that EPA is requesting in this survey in order to estimate the potential risks, the industry baseline, and the costs and benefits of potential regulatory requirements; or are not representative of the universe of entities and activities associated with RRP in P&CBs.

	Although EPA has already collected information about RRP practices from various Federal entities, this information may not be representative of RRP activities in P&CBs.  Renovations of Federal buildings can cost tens or hundreds of millions of dollars and take multiple years to conduct.  This is very different from the RRP activities that many entities (including small businesses) undertake in P&CBs such as preparing surfaces for repainting in a motel, creating an opening in a wall to perform electrical work in a doctor's office, or removing a section of a wall in order to repair a broken water pipe in a shopping mall.  Federal entities may have more time and money to address LBP in the absence of any requirement to do so.  Thus, the prevalence of work practices to control lead exposures from RRP activities may differ between the Federal government and other entities.  EPA's proposed probabilistic method for survey sampling allows a sampling error to be calculated, so it is a better approach from a statistical standpoint than limiting the data collection to Federal entities.  Administering the survey to a random sample of entities will better describe the characteristics of P&CBs, P&CB contractors, RRP activities in P&CBs, and baseline work practices in P&CBs.  Therefore, EPA's survey does not duplicate existing data sources.

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

      In proposing this ICR, EPA provided a 60-day public notice and comment period that ended on December 6, 2013.  EPA received two comments, from the Commercial Properties Coalition and from the Independent Electrical Contractors, during the comment period. Copies of the comments and EPA's response to the comments are included in Attachment 3.

	3(c)	Consultations

      Additionally, under 5 CFR 1320.8(d)(1), OMB requires agencies to consult with potential ICR respondents and data users about specific aspects of ICRs before submitting an ICR to OMB for review and approval.  In accordance with this regulation, EPA submitted questions to nine parties via email.  The individuals contacted were:

      Associated General Contractors
      Leah Pilconis
<EMAIL_ADDRESS>
      Building Owners Managers Association
      Karen Penafiel
<EMAIL_ADDRESS>
      Finishing Contractors Association
      Bob Weaver
<EMAIL_ADDRESS>
      National Association of Home Builders
      Tabby Waqar
<EMAIL_ADDRESS>
      National Association of Plumbing - Heating-Cooling Contractors
      Mark Riso
<EMAIL_ADDRESS>
      National Association of the Remodeling Industry
      Patrick Kennedy
<EMAIL_ADDRESS>
      National Roofing Contractors Association
      Harry Dietz
<EMAIL_ADDRESS>
      National Systems Contractors Association
      Kathy Mrosko
<EMAIL_ADDRESS>
      Painting and Decorating Contractors of America
      Mark Casale
<EMAIL_ADDRESS>
EPA received no responses to its solicitation for consultations.  A copy of EPA's consultation e-mail to the above nine potential respondents is included in Attachment 2.

EPA also conducted a pretest of the contractor survey instrument with 6 respondents.  The respondents were asked to comment on the ease of answering the questions and about how they interpreted the questions.  Several changes to the draft instrument were made based on insights gained by conducting the pretest (see Subpart B of this ICR supporting statement for a description of the changes).

	3(d)	Effects of Less Frequent Collection

This survey is a one time only data collection activity for the respondents.

	3(e)	General Guidelines

This information collection complies with the guidelines in 5 CFR 1320.5(d)(2).

	3(f)	Confidentiality

EPA is not collecting information of a sensitive or private nature.  Only the contractor conducting the survey for EPA will have access to personal identifiers in the raw survey data.  (These personal identifiers include the respondent's name, the respondent's phone number, and the name of the organization the respondent works for.)  All personal identifiers will be stripped from the data before it is conveyed to EPA, so the respondents will be anonymous.  The original survey database will remain under the control of the contractor hired to perform the survey.

	3(g)	Sensitive Questions

Not applicable.  The information requested is not sensitive in nature.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

	4(a)	Respondents and NAICS Codes

Table 4.1 shows the North American Industrial Classification System (NAICS) codes of the establishments affected by this ICR.

	Table 4.1: Respondents Primary Industries: NAICS and Definitions
NAICS Code
                               NAICS Definition
A.  Contractors
                                     2361
Residential Building Construction
                                     2362
Nonresidential Building Construction
                                     2381
Foundation, Structure, and Building Exterior Contractors
                                    2382
Building Equipment Contractors
                                     2383
Building Finishing Contractors
                                     2389
Other Specialty Trade Contractors
B.  Lessors, Property Managers, and Facility Support Services
                                     5612
Facilities Support Services
                                     53112
Lessors of Nonresidential Buildings (except Miniwarehouses)
                                     53131
Real Estate Property Managers
C.  Building Occupants
                                      All
Building occupants include entities from all NAICS except those listed above

	4(b)	Information Requested

		(i)	Data Elements

This survey will be administered to (A) contractors, (B) lessors and property managers, and (C) building occupants (both owners and tenants).  The survey will employ mixed-mode online and phone data collection.  An initial notification letter to respondents will explain the survey and provide instructions for completing the survey online.  Those respondents who do not complete the online survey will be contacted by telephone using trained interviewers calling from a survey telephone center.  Respondents that confirmed that they do nonresidential work, but did not complete the survey after 8 call attempts will be sent an additional mail or courier mail contact with an invitation to complete the survey on the web.  Non-responders who have provided an email address will receive up to two follow-up email reminders, as needed. Table 4.2 summarizes the information the survey will request from respondents.  The survey instruments are included as attachments to this ICR supporting statement.  In order to reduce respondent burden, lessor and property managers and building occupants are not asked all the questions that are being put to contractors.  Instead, these groups are only asked questions that they are in a unique position to answer.

	(ii)	Respondent Activities

Individuals who are contacted to participate in this survey could potentially perform each of the following tasks:

   * Read notification letter;
   * Listen to or read to introductory information;
   * Respond to screening questions; and
   * Complete survey

These activities represent a voluntary information collection for each respondent and are not customary practices of the respondents.

5.	THE INFORMATION COLLECTED - AGENCY ACTIVITIES, COLLECTION
	METHODOLOGY, AND INFORMATION

	5(a)	Agency Activities

The Agency will conduct the following activities to complete the survey:

   * Send letters to respondents, notifying them of the upcoming survey and instructions on how to complete the online version of the final approved questionnaire;
   * Place up to 8 telephone calls (as needed) to each respondent who did not complete the survey online to identify a knowledgeable person to complete the survey and complete the survey over the phone using the Computer Assisted Telephone Interview (CATI) instrument based on final approved questionnaire;
   * Eligible respondents who are particularly hard to reach will be sent an additional mail contact with invitation to complete the survey on the web. Non-responders who have provided an email address will receive up to two follow-up email reminders, as needed;
   * Preliminary data review;
   * Calculation of sampling weights;
   * Non-response bias study;
   * Performance of weighted statistical summaries, variance estimation, and technical analyses; and
   * Report findings.

Table 4.2: Information Collected From Respondents
                               Question Category
                             Purpose of Questions
                       Question Number in Questionnaire

                             Contractor Instrument
                               Property Manager/
                               Lessor Instrument
                         Building Occupant Instrument
Respondent Identification
These questions will be used to identify the individual at the firm with the knowledge required to complete the survey.
S1-S5
S1-S5
S1-S5
Screening and Scope
These questions will be used to determine whether a respondent performs RRP activities in P&CBs. Only those who perform RRP activities in P&CBs will be asked to complete the full survey. Responses from the screening and scope questions will be used to estimate the universe of relevant firms.
Q1-Q2B
Q1-Q3
Q1-Q3
Firm Type and Size
Responses from these questions will be used to assign the appropriate sampling weights.
Q3-Q3B
Q4-Q6
Q4-Q6
Total Number of Activities
The survey includes 11 categories of RRP activities that disturb painted surfaces.  For each of these 11 activity categories, the survey asks two questions: (1) the total number of jobs and (2) the total number where more than a minor amount of paint is disturbed by the respondent establishment's employees.  The response to the second question is of most interest for the analysis.  The primary purpose of the first question will be to aid in the respondents' recall of an accurate answer to the second question.

Contractors who report painting activities will be asked about the numbers of activities where they use the following paint removal techniques: (1) open flame or torch, (2) high temperature heat gun, (3) abrasive blasting, and (4) needle gun/scaler.  In general, the survey collects information about paint removal techniques only for the most recent job a respondent performed.  However, these four techniques are the exception because they potentially generate high levels of lead dust and are believed to be uncommon enough that information about them may not be captured if respondents are only asked about their most recent job.
Q4-Q5.4
Q7-Q7k2
Q7-Q7k3
Recent Job: Job Size, Job Duration, LBP Testing, Access to Work Area
A single activity type that was reportedly performed by each respondent will be randomly selected for a more detailed series of questions.  Once the activity type is selected, the respondent will be prompted to recall the most recent job where LBP might have been disturbed (either because a test indicated the presence of LBP or because surfaces coated with older paint that might have been applied before 1978 were disturbed). If there were no recent jobs where LBP may have been disturbed they will be asked about the most recent job.

Respondents will be asked to characterize the type of building, the number of stories the building has (when asked about an exterior job) and the number of rooms and walls/ceilings where painted surfaces were disturbed (when asked about an interior job).  This will provide information on how much paint might be disturbed and the number of people potentially exposed to dust generated.

For respondents being asked about a recent painting job, they will be asked the percent of the painted surface disturbed and the average number of layers of paint that were removed during the paint preparation.  This will be used to estimate how much paint was removed.

For respondents being asked about a recent window or exterior door job, they will be asked how many windows or doors were replaced.  This will be used to estimate how much paint was disturbed.

All respondents will be asked about: (1) the total duration of the job, (2) the times of day the work was done, and (3) access to the work area by building occupants.  Responses to these questions will be used to inform the level of exposure building occupants might experience.
Q5.5-Q5.10
Q8.1-Q8.5
Q8.1-Q9.5
Job Combinations
For the most recent activity a respondent is asked about, s/he will be asked to report what other activities were performed at the same time.  The responses to these questions will be used to ensure that the estimates of the number of activities are not based on double counting.
Q6-Q6k
N/A
N/A
Containment
There are seven questions related to dust containment practices.  Responses to these questions will be used to estimate the extent to which firms are already using containment practices.  One question is asked to all respondents (Q8a), three are only asked to those being asked about a recent exterior job (Q8b, Q8c, Q8d), and three are only asked to those being asked about a recent interior job (Q8e, Q8f, Q8g).
Q7-Q7g
N/A
N/A
Cleanup
Responses to these questions will be used to estimate the extent to which firms are already using cleaning practices.  There are eight questions related to cleanup practices that will be asked to all respondents being asked about a recent interior job.  Those that report vacuuming will be asked if they used a HEPA vacuum.  Those that reported that there were uncarpeted floors will be asked if they mopped.
Q8-Q8k
N/A
N/A
Paint Preparation and Removal Techniques
Respondents being asked about a recent job involving paint preparation will be asked about the paint preparation and removal techniques they used. There are a total of 16 questions about paint preparation and removal techniques:

   * 9 are asked to all respondents
   * 7 are asked conditional on an affirmative response to another question
Q9a-Q10
N/A
N/A
Routine Cleaning
Respondents will be asked how often most areas of the building receive routine janitorial cleaning.
N/A
Q9
Q10
Motivation for lead-safe work practices
Respondents will be asked what one or two factors usually influence the level of dust containment and cleaning for a given job in P&CBs.  This is asked to help EPA understand what motivates the use of lead safe work practices.
Q11
N/A
N/A
Baseline RRP Certification
Respondents will be asked whether they are already certified under the residential rule.  This is asked because being certified for residential work may affect firms' baseline work practices in P&CBs.  It will also be used to estimate the potential costs if additional firms are required to become certified in order to work in P&CBs.
Q12
N/A
N/A
Open Ended
Respondents will be given the option to provide additional comments or information.
Q13
Q11
Q12

	5(b)	Collection Methodology and Management

Information will be collected using telephone and online survey instruments. Samples of RRP contractors, property managers/lessors, and building occupants will be drawn from the Dun & Bradstreet "Dun's Market Identifiers" (DMI) file provided by Survey Sampling, Inc.  A telephone and online mixed-mode survey appears to be the most appropriate approach for minimizing the two main anticipated challenges: (1) problems of recall (working from memory) and understanding (are the terms used familiar to the respondent), and (2) problems in contacting people who may spend little time in an office.  Telephone surveys maximize cooperation through direct contact with the respondents and provide an opportunity to clarify terms and aid recollection through probes.  Telephone surveys also provide a rapid turnaround time.  Many respondents who may spend little time in the office and have busy schedules may be more likely to respond to an online survey.  The online questionnaire can also include more instructions and definitions of terms for respondents that need clarification.  In addition, the online survey is expected to make it easier to elicit responses from larger firms, who are less likely to have a single individual who can provide the answers to all questions, because multiple individuals can collaborate on the response.

	The survey field period will be relatively short and the target population is not likely to be motivated to participate in the survey.  Contractor respondents are expected to be an especially difficult population to reach and motivate to participate in the study.  They are much less likely than building occupants or management/lessor companies to be in the office during business hours.  Based on experience with the pretest and prior informal EPA surveys (i.e., surveys administered to fewer than 10 respondents), this population is not likely to be motivated to participate in the survey.  (Although not strictly comparable, a prior informal EPA survey of renovation contractors required contacting nearly 1,000 respondents to find 9 that were in the office at the time of the call and would agree to complete the survey.)  Because EPA expects that it will be extremely difficult to get contractors to agree to participate in the survey, the EPA contractor who is administering the survey will offer an incentive of $50 for eligible respondents who complete the full survey.  For budget estimation purposes, EPA's contractor estimated that with the $50 incentive 1,645 of the 2,632 potential respondents that are successfully contacted will complete the screener portion of the survey.  Getting 1,645 respondents to agree to complete the screener portion of the survey by successfully contacting 3,500 respondents is the break-even point for the incentive cost.  Thus, a reduction of 25% or more in the number of respondents EPA's contractor needs to successfully contact would mean that the cost of the incentive would be recouped through lower survey administration costs.  Thus, the Agency believes that the costs of administering the survey would be considerably higher without offering the incentive for contractors.

	Because building occupants and management/lessor companies are more likely to be in the office during business hours and the survey for these respondents is much shorter in duration (5 minutes compared to 30 minutes for the contractor survey) an incentive is not necessary for these groups of respondents.

A mail survey would be very ineffective in this situation, although respondents will receive an initial notification letter describing the survey and encouraging them to follow the instructions provided for completing the survey using the online instrument.

Those respondents who do not complete the survey online will be contacted by telephone by trained interviewers calling from a survey telephone center (Abt SRBI).  The telephone survey instrument will use a CATI screener questionnaire and detailed interview questionnaire.  The main advantage of a telephone survey is the ability to make multiple call attempts over a relatively short field period.  The call attempts and scheduled call backs can be customized to the hours that contractors are available to respond to the survey  -  this may involve early morning calls and late afternoon/evening calls.  The screener questionnaire includes several questions involving skip patterns and terminations that depend on whether the respondent is eligible to complete the detailed interview.  The detailed interview also contains some key skip patterns and a series of questions related to work practices.  This type of questionnaire design is well suited for both the online and CATI administration.  The telephone survey will be conducted from an Abt SRBI telephone center where trained supervisors and interviewers will be assigned to the study.

	5(c)	Small Entity Flexibility

Small entities make up the majority of the establishments that perform the RRP projects that are of interest in this survey.  Therefore, since this is the primary target population for the survey, the majority of respondents will be small entities.  The instrument has been developed to minimize the burden on all respondents while obtaining sufficient and accurate information.

	5(d)	Collection Schedule

      Exhibit 5.1 provides the schedule of the various tasks involved in conducting the proposed survey.  As shown in the schedule, data collection would start within one week of OMB approval of the ICR and would end nine weeks later.  Telephone data collection will start one week after the pre-notification letter. An email alert will be sent to the screened and eligible non-responding businesses after seven weeks to encourage them to complete the survey on the online.  EPA would then process the data and analyze it for potential non-response bias.

Exhibit 5.1: Survey Collection Schedule
Task
                      Week (from receipt of OMB approval)

                                       1
                                       2
                                       3
                                       4
                                       5
                                       6
                                       7
                                       8
                                       9
                                      10
                                      11
                                      12
                                      13
                                      14
Send pre-notification letter to respondents in selected sample

Conduct telephone calls to conduct screener and main questionnaire to complete 120 responses

Analyze data collection of the first two weeks to decide if sample allocation needs to be modified

Resume telephone interviews

Send out email alert to eligible non-responding sample

Process data

Analyze data, including potential non-response bias

6.	ESTIMATING THE BURDEN AND COST OF THE COLLECTION

	6(a)	Estimating Respondent Burden

This section details the estimated burden to respondents participating in this ICR.  For the contractor questionnaire, the accuracy of EPA's burden estimates was confirmed during the survey pretest.  The estimates of the time burden involved in responding to the other two questionnaires are based on the length of the survey instruments.  It is worth noting that the burden on respondents will be less than the length of the questionnaires might seem to imply because no respondents will need to answer all of the questions listed.  For example, after a respondent completes Question 4 in the contractor questionnaire a single activity type will be selected and the respondent will only need to respond to additional questions relevant to that job type.  For example, respondents who are being asked about replacing windows will not be asked questions about paint removal techniques, and respondents being asked about exterior painting will not be asked questions about interior containment and clean-up practices.

The respondent burden is presented by respondent type.  Two types of respondents were identified:

   * Ineligible respondents do not perform or make decisions related to RRP activities in P&CBs.  They complete a portion of the survey screening to determine their ineligibility.  Hereafter, respondents of this type are referred to as initial completes.
   * Eligible respondents perform or make decisions related to RRP activities in P&CBs.  Hereafter, respondents of this type are referred to as full completes.

It is estimated that the screening portion of the survey will take about 3 minutes on average.  For respondents completing the contractor questionnaire, it is estimated that the remaining portion of the survey will require about 30 minutes on average.  For respondents completing the property lessor/manager or building occupant questionnaires, the remaining portion of the survey is estimated to require about 5 minutes on average.  Table 6.1 summarizes the burden per respondent.

Table 6.1: Average Burden Per Respondent
Respondent Type
Average Per-Respondent Burden*
Initial Completes
0.05 hours
Full Completes (Contractors)
0.55 hours
Full Completes (Lessors, Property Managers, and Facility Support Services; Building Occupants)
0.13 hours
*Note that the respondent burden for a full complete includes the time to answer the screening questions.

	6(b)	Estimating Respondent Costs

		(i)	Estimating Labor Costs

EPA estimated respondent costs using the burden estimates presented above and the average wage figures provided by the Bureau of Labor Statistics (BLS) occupational employment statistics series.  Wage rates for each category of personnel are derived with methods and from sources either identical to or similar to those used in prior ICR renewals and economic analyses for EPA's RRP program.  According to the December 2012 BLS data for Employer Costs for Employee Compensation, wages and salaries accounted for 69.2% of employee compensation, implying a wage multiplier of 1.445.  Based on Appendix I of the National Association of Home Builders' 2010 Cost of Doing Business Study, an additional 8.3% was added to the fringe multiplier for overhead costs to estimate a multiplier of 1.53 for fully loading wages.  A uniform loading factor of 53% for fringe benefits and overhead was applied to all categories of labor for this ICR.

Contractors' fully loaded wages ($47/hour) are estimated from the wages earned by First-Line Supervisors/Managers of Construction Trades and Extraction Workers (Occupation 47-1011).  Lessors and property managers' fully loaded wages ($47/hour) are estimated from the wages earned by Property, Real Estate and Community Association Managers (Occupation 11-9140). The wage rates ($78/hour) for building occupant respondents are estimated as the fully loaded wages earned by Miscellaneous Managers (Occupation 11-9190). Table 6.2 presents the wages for the occupations that best match the ICR labor categories. Table 6.3 presents the individual respondent costs by respondent type associated with this ICR.

Table 6.2: Private Sector Wage Rates for Calculating Labor Costs (2012$)
                               ICR Labor Category
                            BLS Occupation Category
                           May 2012 Hourly Wage Rate
                      Hourly Wage with Fringe and Overhead
 Contractors
 First-Line Supervisors of Construction Trades and Extraction Workers
                                    $30.40
                                      $47
 Lessors and Property Managers
 Property, Real Estate, and Community Association Managers
                                     $30.56
                                      $47
 Building Occupants
Miscellaneous Managers
                                    $50.79
                                      $78

Table 6.3: Average Individual Respondent Cost
                                Respondent Type
                        Average Per-Respondent Burden*
                         Respondent Loaded Hourly Wage
                                    (2012$)
                       Average Labor Cost per-Respondent
                                  Contractors
Initial Completes
                                  0.05 hours
                                     $47
                                     $2.35
Full Completes
                                  0.55 hours
                                     $47
                                    $25.85
                         Lessors and Property Managers
Initial Completes
                                  0.05 hours
                                     $47
                                     $2.35
Full Completes
                                  0.13 hours
                                     $47
                                     $6.11
                              Building Occupants
Initial Completes
                                  0.05 hours
                                     $78
                                     $3.90
Full Completes
                                  0.13 hours
                                     $78
                                    $10.14
*Note that the respondent burden for a full complete includes the time to answer the screening question.

		(ii)	Estimating Capital and Operations and Maintenance Costs

	EPA does not expect respondents to incur any capital or operations and maintenance (O&M) costs.  This information collection is voluntary and does not require special equipment.

		(iii)	Capital/Start-up Operating and Maintenance (O&M) Costs

	Not applicable.

		(iv)	Annualizing Capital Costs

	Not applicable.

	6(c)	Estimating Agency Burden and Costs

      EPA will use in-house staff and contractors to conduct the survey.  EPA staff will oversee the contractor staff working on the survey, and send out the pre-notification letters to potential respondents.  It is estimated that administering the survey will require 1/7th of a full-time employee (FTE) at EPA headquarters.  The cost for EPA staff is estimated to be $77.62 per hour, based on the 2012 wage rate for a GS-13, Step 5 employee in the Washington-Baltimore locality, with a government overhead factor of 1.6 to account for fringe benefits and overhead.  This is equivalent to an EPA staff cost of approximately $23,064.  EPA's cost for sending the pre-notification letters will be $112,000, the cost of sending 66,000 pre-notification letters costing $1.69 each ($0.49 in postage and $1.20 in materials and processing cost).

      EPA will incur costs for contractor staff to administer the telephone survey, process and analyze the data, and prepare survey documentation.

      Table 6.4 presents the Agency costs for each activity associated with conducting the survey.  Total Agency costs are estimated at $710,000.

Table 6.4.  Estimated Agency Costs
Activity
                                                                    Agency Cost
EPA Staff Time
                                                                       $23,000
Pre-Notification Letters
                                                                      $112,000
CATI and Web Programming
                                                                       $20,000
Sampling
                                                                       $22,000
Interviewing and Web Data Collection
                                                                      $466,000
Data Cleaning and Processing
                                                                       $31,000
Weighting
                                                                       $23,000
Incentives
                                                                       $13,000
Total Cost
                                                                      $710,000

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

See section 2(b) of Part B of this supporting statement for a description of how the necessary sample sizes (i.e., respondent universe) were estimated.  The per-respondent burden and cost are described above.  Table 6.5 presents the respondent universe and the total hour and cost burden by respondent type.

Table 6.5: ICR Respondent Universe and Total Burden Cost
                               Respondent Type*
                        Estimated Respondent Universe*
                   Estimated Universe of Small Respondents**
                            Per-Respondent Burden*
                                    (hours)
                            Total Respondent Burden
                                    (hours)
                          Per-Respondent Cost (2012$)
                         Total Respondent Cost (2012$)
A.  Contractors
Initial Completes
                                                                          1,391
                                     1,349
                                                                           0.05
                                                                             70
                                                                         $2.35
                                                                        $3,269
Full Completes
                                                                            254
                                      246
                                                                           0.55
                                                                            140
                                                                        $25.85
                                                                        $6,566
B.  Lessors and Property Managers
Initial Completes
                                                                          1,972
                                     1,913
                                                                           0.05
                                                                             99
                                                                         $2.35
                                                                        $4,634
Full Completes
                                                                             68
                                      66
                                                                           0.13
                                                                              9
                                                                         $6.11
                                                                          $415
C.  Building Occupants
Initial Completes
                                                                          4,720
                                     4,578
                                                                           0.05
                                                                            236
                                                                         $3.90
                                                                       $18,408
Full Completes
                                                                             80
                                      78
                                                                           0.13
                                                                             10
                                                                        $10.14
                                                                          $811
                          Summary for All Respondents
Initial Completes
                                                                          8,083
                                     7,840
                                                                         0.0501
                                                                            405
                                                                          $3.26
                                                                        $26,311
Full Completes
                                                                            402
                                      390
                                                                         0.3955
                                                                            159
                                                                         $19.38
                                                                         $7,792
All Completes
                                                                          8,485
                                     8,231
                                                                         0.0665
                                                                            564
                                                                          $4.02
                                                                        $34,103
*Note that the respondent burden for a full complete includes the time to answer the screening questions.
**Note that larger firms (who are expected perform disproportionately more RRP activities) will be oversampled.  While over 99% of the entities in these industries are small, roughly 97% of survey respondents are expected to be small entities.

	6(e)	Bottom Line Burden Hours and Cost Tables

Table 6.6 details the total bottom-line burden (respondent and EPA) associated with this ICR.  Tables 6.1 through 6.5 detail how these total figures were derived.

Table 6.6: Bottom Line Burden and Costs
                                 Cost Category
                                  Labor Hours
                                     Cost
Respondent Labor
                                      564
                                   $34,103
EPA Labor
                                     N.A.
                                   $23,000
Other Direct EPA Costs
                                     N.A.
                                   $687,000
Total
                                      564
                                   $744,103

	6(f)	Reasons for Change in Burden

Not applicable because this request does not renew or modify an existing ICR.

	6(g)	Burden Statement

The annual public burden for this collection of information is estimated to average 0.07 hours per response.  This includes an average respondent burden of 0.05 hours for respondents that are not eligible to complete the full study (initial completes) and 0.40 hours for respondents who complete the full study (full completes).  Burden is defined in 5 CFR 1320.3(b).  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 are listed in 40 CFR part 9 and included on the related collection instrument or form, if applicable.

The Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OPPT-2013-0715, which is available for online viewing at www.regulations.gov, or in-person viewing at the Pollution Prevention and Toxics Docket in the EPA Docket Center (EPA/DC).  The EPA/DC Public Reading Room is located in the William Jefferson Clinton (WJC) West Building, Room 3334, 1301 Constitution Ave., N.W., 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 EPA/DC Public Reading Room is<PHONE_NUMBER>, and the telephone number for the Pollution Prevention and Toxics Docket is<PHONE_NUMBER>.

You may submit comments regarding 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. Submit your comments, referencing Docket ID No. EPA-HQ-OPPT-2013-0715 and OMB Control No. 2070-NEW, to (1) EPA online using www.regulations.gov (our preferred method), or by mail to: Pollution Prevention and Toxics Docket, Environmental Protection Agency Docket Center (EPA/DC), Mailcode: 28221T, 1200 Pennsylvania Ave., N.W., Washington, DC 20460, and (2) OMB by mail to: Office of Information and Regulatory Affairs, Office of Management and Budget (OMB), Attention: Desk Officer for EPA, 725 17th Street, N.W., Washington, DC 20503.

ATTACHMENTS TO THE SUPPORTING STATEMENT

Attachment 1 - Toxic Substances Control Act Section 402; 15 U.S.C. 2681 et. seq.

Attachment 2 - Public Consultations

Attachment 3 - Public Comments on Proposed ICR and EPA Responses to Public Comments

Attachment 4 - EPA Public and Commercial Building Contractor Survey Questionnaire

Attachment 5 - EPA Public and Commercial Building Manager/Lessor Survey Questionnaire

Attachment 6 - EPA Public and Commercial Building Occupant Survey Questionnaire


[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68422-68424]
[FR Doc No: 2016-23924]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-2655]

Center for Devices and Radiological Health Veteran Amputee
Devices; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
following public workshop entitled ``Center for Devices and
Radiological Health Veteran Amputee Devices.'' The purpose of this
workshop is to engage all stakeholders involved in the research,
development, and marketing of prosthetic limb medical devices used by
veteran amputees. A specific goal is to engage veteran amputees who use
prosthetic limb medical devices and hear their views on these devices
so that these perspectives may be considered in the total product life
cycle of prosthetic limb devices.

DATES: The public workshop will be held on October 31, 2016, from 9
a.m. to 4 p.m. Submit either electronic or written comments on the
public workshop by November 30, 2016.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting
participants (non-FDA employees) is through Building 1 where routine
security check procedures will be performed. For parking and security
information, please refer to http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilities/WhiteOakCampusInformation/ucm241740.htm.
    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-2655 for ``Center for Devices and Radiological Health
Veteran Amputee Devices.'' 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: Fabienne Santel, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3502, Silver Spring, MD 20993, 301-796-
9644, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    The Center for Devices and Radiological Health (CDRH) is committed
to including views of patients on the total product life cycle of
medical devices. To better understand their needs, CDRH plans to engage
patients throughout our regulatory process. CDRH is interested in
patients contributing their views, data, and resources to improve the
total product life cycle for medical devices, reduce adverse events,
and improve communication about the risks and benefits that matter most
to them.
    Together with other centers and offices across FDA, we are testing
and developing ways to engage patients and capture their views through
public workshops. The CDRH Veteran Amputee Devices is one such workshop
intended to engage veteran amputees, such as those patients from the
Walter Reed National Military Medical Center, Warrior Clinic, who use
prosthetic limb medical devices.

II. Topics for Discussion at the CDRH Veteran Amputee Devices Public
Workshop

    Topics to be discussed at the public workshop include, but are not
limited to the following:
     Introduce the CDRH Total Product life Cycle (TPLC) for
prosthetic limb devices.
     A focus group to obtain information on priorities for
upper-limb prosthetics from the perspective of upper-limb amputees.
     Presentations from prosthetic limb device manufacturer.
     Question and answer session where patients, their
caregivers and other interested parties have an opportunity to present
their views and ask questions about the total product life cycle of
medical devices.
    Registration: Registration is free and available on a first-come,
first-served basis. Persons interested in attending the CDRH Veteran
Amputee Devices public workshop must register online by October 24,
2016. Early registration is recommended because facilities are limited
and, therefore, FDA may limit the number of participants from each
organization. If time and space permit, onsite registration on the day
of the public workshop will be begin at 8 a.m.
    If you need special accommodations due to a disability, please
contact Susan Monahan, Center for Devices and Radiological Health,
Office of Communication, Education (OCE),<PHONE_NUMBER> email:
<EMAIL_ADDRESS>no later than October 17, 2016.
    To register for the public workshop, please visit FDA's Medical
Devices News & Events--Workshops & Conferences calendar at http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm.
(Select this meeting/public workshop from the posted events list.)
Please provide complete contact information for each attendee,
including name, title, affiliation, address, email, and telephone
number. Those without Internet access should contact Fabienne Santel to
register (see FOR FURTHER INFORMATION CONTACT). Registrants will
receive confirmation after they have been accepted. You will be
notified if you are on a waiting list.
    Streaming Webcast of the Public Workshop: This public workshop will
also be Webcast. The Webcast link will be available on the registration
Web page after October 21, 2016. Organizations are requested to view
using one connection per location. If you have never attended a Connect
Pro event before, test your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a
quick overview of the Connect Pro program, visit http://www.adobe.com/go/connectpro_overview. FDA has verified the Web site addresses in this
document, as of the date this document publishes in the Federal
Register, but Web sites are subject to change over time.
    Requests for Oral Presentations: This public workshop includes a
public comment session and topic-focused sessions. During online
registration, you may indicate if you wish to present during a public
comment session or participate in a specific session, and which topics
you wish to address. FDA has included general topics in this document.
FDA will do its best to accommodate requests to make public comments or
give presentations during the focused sessions. Individuals and
organizations with common interests are urged to consolidate or
coordinate their presentations, and request time for a joint
presentation, or submit requests for designated representatives to
participate in the focused sessions. FDA will determine the amount of
time allotted to each presenter and the approximate time each oral
presentation is to begin, and will select and notify participants by
October 17, 2016. All requests to make oral presentations must be
received by October 10, 2016. If selected for presentation, any
presentation materials must be emailed to Fabienne Santel (see FOR
FURTHER INFORMATION CONTACT) no later than October 28, 2016. If you are
a manufacturer and wish to have a display table, please submit this

request by October 17, 2016. Space is limited; therefore, FDA will
select and notify manufacturers by October 24, 2016. No commercial or
promotional material will be permitted to be presented or distributed
at the public workshop.
    FDA is holding this public workshop to obtain views from patients
on prosthetic limb devices so that these perspectives may be considered
in the total product life cycle of prosthetic limb medical devices. In
order to permit the widest possible opportunity to obtain public
comment, FDA is soliciting either electronic or written comments on all
aspects of the public workshop topics. The deadline for submitting
comments related to this patient workshop is November 30, 2016.
    Transcripts: Please be advised that as soon as a transcript is
available, it will be accessible at http://www.regulations.gov. It may
be viewed at the Division of Dockets Management (see ADDRESSES). A
transcript will also be available in either hardcopy or on CD-ROM,
after submission of a Freedom of Information request. The Freedom of
Information office address is available on the Agency's Web site at
http://www.fda.gov. A link to the transcripts will also be available
approximately 45 days after the public workshop on the Internet at
http://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/default.htm. (Select this public workshop from the posted events list).

    Dated: September 26, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23924 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 224 (Tuesday, November 20, 2012)]
[Notices]
[Pages 69631-69632]
[FR Doc No: 2012-28149]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-D-0847]

Draft Guidance for IRBs, Clinical Investigators, and Sponsors:
IRB Responsibilities for Reviewing the Qualifications of Investigators,
Adequacy of Research Sites, and the Determination of Whether an IND/IDE
Is Needed; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for IRBs, Clinical
Investigators, and Sponsors: IRB Responsibilities for Reviewing the
Qualifications of Investigators, Adequacy of Research Sites, and the
Determination of Whether an IND/IDE Is Needed.'' The draft guidance
announced in this notice is intended to assist institutional review
boards (IRBs), clinical investigators, and sponsors involved in
clinical investigations of FDA-regulated products in fulfilling
responsibilities related to reviewing the qualifications of
investigators, adequacy of research sites, and the determination of
whether an investigational new drug (IND) application or
investigational device exemption (IDE) is needed in order to assure the
protection of the rights and welfare of human subjects in clinical
investigations.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by January 22, 2013.

ADDRESSES: Submit written requests for single copies of this draft
guidance to the Division of Drug Information, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 2201, Silver Spring, MD 20993-0002 (1-
888-463-6332 or<PHONE_NUMBER>); or the Office of Communication, Outreach
and Development (HFM-40), Center for Biologics Evaluation and Research,
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448 (1-800-835-4709 or<PHONE_NUMBER>); or the
Division of Small Manufacturers, International and Consumer Assistance,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4622, Silver
Spring, MD 20993 (1-800-638-2041 or<PHONE_NUMBER>). Send one self-
addressed adhesive label to assist the office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.
    Submit electronic comments on the draft guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Doreen Kezer, Office of Good Clinical
Practice, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
32, Rm. 5109, Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance entitled
``Guidance for IRBs, Clinical Investigators, and Sponsors: IRB
Responsibilities for Reviewing the Qualifications of Investigators,
Adequacy of Research Sites, and the Determination of Whether an IND/IDE
Is Needed.'' This guidance is intended to assist IRBs, clinical
investigators, and sponsors involved in clinical investigations of FDA-
regulated

products in determining that the proposed research satisfies the
criteria for approval contained in 21 CFR 56.111, that ``* * * the
risks to subjects are minimized * * * and reasonable in relation to
anticipated benefits, if any, to subjects * * *.'' In particular, the
guidance addresses the IRB's role in reviewing: (1) The qualifications
of investigators, (2) the adequacy of the research site, and (3) the
determination of whether an IND/IDE is needed. When finalized, this
guidance will supersede Question 56 in FDA's January 1998 guidance
entitled ``Institutional Review Boards Frequently Asked Questions--
Information Sheet Guidance for Institutional Review Boards and Clinical
Investigators.'' \1\
---------------------------------------------------------------------------

    \1\ See http://www.fda.gov/RegulatoryInformation/Guidances/ucm126420.htm#GeneralQuestions.
---------------------------------------------------------------------------

    FDA is issuing this as a draft guidance. Although many of these
recommendations have appeared in other FDA guidance documents, FDA has
compiled the information here in order to assure that all IRBs are
aware of and have access to it. The guidance also explains how IRBs may
efficiently fulfill these important responsibilities.
    To enhance human subject protection and reduce regulatory burden,
the Department of Health and Human Services (HHS) Office for Human
Research Protections (OHRP) and FDA have been actively working to
harmonize the Agencies' regulatory requirements and guidance for human
subject research. This guidance document was developed as a part of
these efforts and in consultation with OHRP. In addition, FDA
acknowledges HHS's publication of the advanced notice of proposed
rulemaking (ANPRM), ``Human Subjects Research Protections: Enhancing
Protections for Research Subjects and Reducing Burden, Delay, and
Ambiguity for Investigators,'' in the Federal Register of July 26, 2011
(76 FR 44512). In the ANPRM, HHS sought comment on whether the Federal
human subject protection regulations should be modified in a number of
ways. In finalizing this draft guidance, ``IRB Responsibilities for
Reviewing the Qualifications of Investigators, Adequacy of Research
Sites, and the Determination of Whether an IND/IDE Is Needed,'' FDA
intends to consider relevant public comments submitted in response to
both the draft guidance and the ANPRM.
    The draft guidance is being issued consistent with FDA's Good
Guidance Practices (GGPs) regulation (21 CFR 10.115). The draft
guidance, when finalized, will represent FDA's current thinking on this
topic. It does not create or confer any rights for or on any person and
does not operate to bind FDA or the public. An alternative approach may
be used if such approach satisfies the requirements of the applicable
statutes and regulations.

II. The Paperwork Reduction Act of 1995

    This draft guidance includes information collections provisions
that are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act (PRA) of 1995 (44 U.S.C. 3501-3520).
The collections of information referenced in this guidance that are
related to IRB recordkeeping requirements under 21 CFR 56.115 have been
approved under OMB control number 0910-0130; the collections of
information under 21 CFR Part 312 have been approved under OMB control
number 0910-0014; and the collections of information under 21 CFR Part
812 have been approved under OMB control number 0910-0078. In
accordance with the PRA, prior to publication of any final guidance
document, FDA intends to solicit public comment and obtain OMB approval
for any information collections recommended in this guidance that are
new or that would represent material modifications to these previously
approved collections of information found in FDA regulations.

III. Comments

    Interested persons may submit either written comments regarding
this document to the Division of Dockets Management (see ADDRESSES) or
electronic comments to http://www.regulations.gov. It is only necessary
to send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinicalTrials/ProposedRegulationsandDraftGuidances/default.htm or http://www.regulations.gov.

    Dated: November 15, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-28149 Filed 11-19-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 77, Number 137 (Tuesday, July 17, 2012)]
[Rules and Regulations]
[Pages 41916-41919]
[FR Doc No: 2012-17277]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R10-OAR-2011-0724, FRL-9676-6]

Approval and Promulgation of Implementation Plans; Idaho:
Infrastructure Requirements for the 1997 8-Hour Ozone National Ambient
Air Quality Standard; Prevention of Significant Deterioration
Greenhouse Gas Permitting Authority and Tailoring Rule

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is approving the State Implementation Plan (SIP)
submittals from the State of Idaho demonstrating that the Idaho SIP
meets the requirements of section 110(a)(1) and (2) of the Clean Air
Act (CAA) for the National Ambient Air Quality Standard (NAAQS)
promulgated for ozone on July 18, 1997. EPA finds that the current
Idaho SIP meets the following 110(a)(2) infrastructure elements for the
1997 8-hour ozone NAAQS: (A), (B), (C), (D)(ii), (E)(i), (E)(iii), (F),
(G), (H), (J), (K), (L), and (M). EPA is taking no action on CAA
section 110(a)(2)(E)(ii) at this time. We will address the requirements
of this sub-element in a separate action. EPA is also approving a SIP
revision that applies Idaho's Prevention of Significant Deterioration
(PSD) Program to greenhouse gas (GHG) emitting sources above certain
thresholds, updates Idaho's SIP to incorporate by reference revised
versions of specific federal regulations, and removes unnecessary
language from the SIP due to the incorporation by reference of the
federal NAAQS and PSD regulations. In addition, EPA is rescinding the
Federal Implementation Plan (FIP) put in place to ensure the
availability of a permitting authority for greenhouse gas emitting
sources in Idaho.

DATES: This action is effective on August 16, 2012.

ADDRESSES: EPA has established a docket for this action under Docket ID
No. EPA-R10-OAR-2011-0724. All documents in the docket are listed on
the www.regulations.gov Web site. Although listed in the index, some
information may not be publicly available, i.e., Confidential Business
Information or other information whose disclosure is restricted by
statute. Certain other material, such as copyrighted material, is not
placed on the Internet and will be publicly available only in hard copy
form. Publicly available docket materials are available either
electronically through www.regulations.gov or in hard copy at EPA
Region 10, Office of Air, Waste and Toxics (AWT-107), 1200 Sixth
Avenue, Suite 900, Seattle, WA 98101. EPA requests that you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday, 8:30 to 4:30, excluding Federal
holidays.

FOR FURTHER INFORMATION CONTACT: Kristin Hall at telephone number:
(206) 553-6357, email address<EMAIL_ADDRESS>or the above EPA,
Region 10 address.

SUPPLEMENTARY INFORMATION: Throughout this document wherever ``we'',
``us'' or ``our'' are used, we mean EPA. Information is organized as
follows:

Table of Contents

I. Background
II. Scope of Action
III. Final Action
IV. Statutory and Executive Order Reviews

I. Background

    On July 18, 1997, EPA promulgated a new NAAQS for ozone. EPA
revised the ozone NAAQS to provide an 8-hour

averaging period which replaced the previous 1-hour averaging period,
and the level of the NAAQS was changed from 0.12 parts per million
(ppm) to 0.08 ppm (62 FR 38856). The CAA requires SIPs meeting the
requirements of sections 110(a)(1) and (2) be submitted by states
within 3 years after promulgation of a new or revised standard.
Sections 110(a)(1) and (2) require states to address basic SIP
requirements, including emissions inventories, monitoring, and modeling
to assure attainment and maintenance of the standards, so-called
``infrastructure'' requirements. To help states meet this statutory
requirement for the 1997 8-hour ozone NAAQS, EPA issued guidance to
address infrastructure SIP elements under section 110(a)(1) and (2).\1\
In the case of the 1997 8-hour ozone NAAQS, states typically have met
the basic program elements required in section 110(a)(2) through
earlier SIP submissions in connection with previous ozone standards. On
September 15, 2008, the State of Idaho submitted a certification to EPA
certifying that Idaho's SIP meets the infrastructure obligations for
the 1997 8-hour ozone and 1997 PM2.5 NAAQS. The
certification included an analysis of Idaho's SIP as it relates to each
section of the infrastructure requirements with regard to the 1997 8-
hour ozone and 1997 PM2.5 NAAQS. Subsequently, on June 24,
2010, Idaho submitted an updated certification to EPA for sections
110(a)(2)(D) and 110(a)(2)(G). On April 11, 2012, EPA published a
notice of proposed rulemaking (NPR) to act on Idaho's infrastructure
SIP for the 1997 ozone NAAQS (77 FR 21702). Specifically in the NPR,
EPA proposed approval of Idaho's SIP as meeting the requirements for
the following 110(a)(2) infrastructure elements for the 1997 8-hour
ozone NAAQS: (A), (B), (C), (D)(ii), (E)(i), (E)(iii), (F), (G), (H),
(J), (K), (L), and (M). As discussed in the NPR, the proposed action
did not address CAA section 110(a)(2)(E)(ii), which will be addressed
in a separate action.
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    \1\ William T. Harnett, Director, Air Quality Policy Division,
Office of Air Quality Planning and Standards. ``Guidance on SIP
Elements Required Under Sections 110(a)(1) and (2) for the 1997 8-
hour Ozone and PM2.5 National Ambient Air Quality
Standards.'' Memorandum to EPA Air Division Directors, Regions I-X,
October 2, 2007.
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    In the NPR, EPA also proposed to approve portions of the June 20,
2011, SIP revision submitted by Idaho that applies Idaho's PSD Program
to GHG-emitting sources above certain thresholds, updates Idaho's SIP
to incorporate by reference revised versions of specific federal
regulations, and removes unnecessary language from the SIP due to the
incorporation by reference of the federal NAAQS and PSD regulations. In
addition, EPA proposed to rescind the FIP put in place to ensure the
availability of a permitting authority for GHG-emitting sources in
Idaho.
    EPA provided a 30-day review and comment period on the NPR,
published April 11, 2012 (77 FR 21702). The public comment period for
EPA's NPR closed on May 11, 2012. EPA received no comments on the
proposed action.

II. Scope of Action

    Idaho has not demonstrated authority to implement and enforce Idaho
Administrative Procedures Act (IDAPA) Chapter 58 within ``Indian
Country'' as defined in 18 U.S.C. 1151.\2\ Therefore, EPA proposes that
this SIP approval not extend to ``Indian Country'' in Idaho. See CAA
sections 110(a)(2)(A) (SIP shall include enforceable emission limits),
110(a)(2)(E)(i) (State must have adequate authority under State law to
carry out SIP), and 172(c)(6) (nonattainment SIPs shall include
enforceable emission limits). This is consistent with EPA's previous
approval of Idaho's PSD program, in which EPA specifically disapproved
the program for sources within Indian Reservations in Idaho because the
State had not shown it had authority to regulate such sources. See 40
CFR 52.683(b). It is also consistent with EPA's approval of Idaho's
title V air operating permits program. See 61 FR 64622 (December 6,
1996) (interim approval does not extend to Indian Country); 66 FR 50574
(October 4, 2001) (full approval does not extend to Indian Country).
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    \2\ ``Indian country'' is defined under 18 U.S.C. 1151 as: (1)
All land within the limits of any Indian reservation under the
jurisdiction of the United States Government, notwithstanding the
issuance of any patent, and including rights-of-way running through
the reservation, (2) all dependent Indian communities within the
borders of the United States, whether within the original or
subsequently acquired territory thereof, and whether within or
without the limits of a State, and (3) all Indian allotments, the
Indian titles to which have not been extinguished, including rights-
of-way running through the same. Under this definition, EPA treats
as reservations trust lands validly set aside for the use of a Tribe
even if the trust lands have not been formally designated as a
reservation. In Idaho, Indian country includes, but is not limited
to, the Coeur d'Alene Reservation, the Duck Valley Reservation, the
Reservation of the Kootenai Tribe, the Fort Hall Indian Reservation,
and the Nez Perce Reservation as described in the 1863 Nez Perce
Treaty.
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III. Final Action

    EPA is approving the SIP submittals from the State of Idaho
demonstrating that the Idaho SIP meets the requirements of section
110(a)(1) and (2) of the CAA for the NAAQS promulgated for ozone on
July 18, 1997. EPA is approving in full the following section 110(a)(2)
infrastructure elements for Idaho for the 1997 ozone NAAQS: (A), (B),
(C), (D)(ii), (E)(i), (E)(iii), (F), (G), (H), (J), (K), (L), (M). EPA
is taking no action on CAA section 110(a)(2)(E)(ii) at this time. EPA
will address the requirements of this sub-element in a separate action.
EPA is also approving a portion of Idaho's June 20, 2011, SIP submittal
that applies Idaho's PSD Program to GHG-emitting sources at the
emissions thresholds and in the same time frames as those specified in
the Tailoring Rule (75 FR 31514, June 3, 2010). In conjunction with
this approval of Idaho's PSD program for GHG-emitting sources, EPA is
rescinding the FIP at 40 CFR 52.37 which provides for EPA to be the PSD
permitting authority for GHG-emitting sources in Idaho.
    EPA is also approving portions of Idaho's June 20, 2011, SIP
submittal to revise the incorporation by reference of federal
regulations revised as of July 1, 2010, in order to ensure Idaho's SIP
is up to date with changes to federal regulations. EPA is not acting on
the portions of the SIP revision that are not related to the criteria
pollutants regulated under title I of the CAA or the requirements for
SIPs under section 110 of the CAA. Finally, EPA is approving the
removal of language from the Idaho SIP that has become unnecessary due
to Idaho's incorporation by reference of the federal NAAQS and the
federal PSD regulations. Specifically, EPA is approving the removal of
the subsections of IDAPA <IP_ADDRESS>7 ``Ambient Air Quality Standards
for Specific Pollutants'' that relate to pollutants for which EPA has
promulgated a NAAQS, and which are now unnecessary because Idaho has
incorporated the federal NAAQS by reference into the state SIP. EPA is
also approving the changes to Idaho's PSD regulations at IDAPA
<IP_ADDRESS>1.01 to remove the increments table in its entirety, and to
instead reference the federal PSD increment requirements contained in
40 CFR 52.21(c), which are incorporated by reference in the Idaho SIP.
This action is being taken under section 110 and part C of the CAA.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.

Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the state, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by September 17, 2012. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Carbon monoxide,
Incorporation by reference, Intergovernmental relations, Lead, Nitrogen
dioxide, Ozone, Particulate matter, Reporting and recordkeeping
requirements, Sulfur oxides, Volatile organic compounds.

    Authority:  42 U.S.C. 7401 et seq.

    Dated: June 29, 2012.
Dennis J. McLerran,
Regional Administrator, Region 10.

    40 CFR Part 52 is amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart A--General Provisions

0
2. Sec.  52.37 is amended by removing and reserving paragraph (b)(4).

Subpart N--Idaho

0
3. In Sec.  52.670:
0
a. The table in paragraph (c) is amended by revising entry 107,
removing entry 577, and revising entry 581.
0
b. The table in paragraph (e) is amended by adding an entry at the end
of the table for ``Section 110(a)(2) Infrastructure Requirements for
the 1997 8-hour Ozone NAAQS.''

Sec.  52.670  Identification of plan.

* * * * *
    (c) * * *

                                         EPA-Approved Idaho Regulations
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                                                        State effective
         State citation              Title/subject           date          EPA approval date     Explanations
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      Idaho Administrative Procedures Act (IDAPA) 58.01.01--Rules for the Control of Air Pollution in Idaho
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                                                  * * * * * * *
107.............................  Incorporations by   10/6/10, 5/8/09, 3/ 7/17/2012 [Insert   Except Section
                                   Reference.          30/07,              page number where   107.03(f) through
                                                      3/20/04, 7/1/97, 5/  the document        (m) and (o).
                                                       1/94.               begins].
                                                  * * * * * * *
581.............................  Prevention of       10/6/10, 4/11/06,   7/17/2012 [Insert
                                   Significant         7/1/97,             page number where
                                   Deterioration      5/1/94............   the document
                                   (PSD) Increments.                       begins].
                                                  * * * * * * *
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* * * * *
    (e) * * *

                    EPA-Approved Idaho Nonregulatory Provisions and Quasi-Regulatory Measures
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                                      Applicable
      Name of SIP provision       geographic or non-    State submittal    EPA approval date       Comments
                                    attainment area          date
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                                                  * * * * * * *
Section 110(a)(2) Infrastructure  Statewide.........  9/15/2008, 6/24/    7/17/2012 [Insert   This action
 Requirements for the 1997 8-                          2010.               page number where   addresses
 hour Ozone NAAQS.                                                         the document        following CAA
                                                                           begins].            elements or
                                                                                portions thereof:
                                                                                110(a)(2)(A),
                                                                                (B), (C),
                                                                                (D)(ii), (E)(i),
                                                                                (E)(iii), (F),
                                                                                (G), (H), (J),
                                                                                (K), (L), and
                                                                                (M).
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[FR Doc. 2012-17277 Filed 7-16-12; 8:45 am]
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