  SEQ CHAPTER \h \r 1

October 25, 2006

INFORMATION COLLECTION REQUEST

 for

  ASSESSMENT OF EPA

PARTNERSHIP PROGRAMS

EPA

The United States Environmental Protection Agency

Table of Contents

Title										Page

1.	Identification of the Information Collection						  1

1(a) Title of the Information Collection						  	  1

1(b) Short Characterization/Abstract							  1

2.	Need for and Use of the Collection							  2

2(a) Need/Authority for the Collection						  	  2

2(b) Practical Utility/Users of the Data						  	  2

3. 	Non-duplication, Consultations, and Other Collection Criteria
3

3(a) Non-duplication									  3

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

3(c) Consultations									  3

3(d) Effects of Less Frequent Collection						  	  3

3(e) General Guidelines								  	  3

3(f) Confidentiality								  	  3

3(g) Sensitive Questions								  3

4.	The Respondents and The Information Requested					  4

4(a) Respondents/SIC Codes								  4

4(b) Information Requested								  4

	(i) Data items, including record keeping requirements				  4

	(ii) Respondent activities								  4

5.	The Information Collected--Agency Activities, Collection Methodology,

and Information Management							  	  4

5(a) Agency Activities						 		  	  4

5(b) Collection Methodology and Management					   	  5

5(c) Small Entity Flexibility								  5

5(d) Collection Schedule								  5

6.	Estimating the Burden and Cost of the Collection					  5

6(a) Estimating Respondent Burden							  5

6(b) Estimating Respondent Costs							  7

       (i) Estimating Labor Costs							  	  7

       (ii) Estimating Capital and Operations and Maintenance Costs
8

       (iii) Capital/Start-up vs. Operations and Maintenance (O&M) Costs
	  	  8

       (iv) Annualizing Capital Costs							  8

6(c) Estimating Agency Burden and Cost						  8

6(d) Estimating the Respondent Universe and Total Burden and Costs
9

6(e) Bottom Line Burden Hours and Cost Tables					  	 10

6(f) Reasons for Change in Burden							 11

6(g) Burden Statement								  	 11

List of Tables

Table 6-1	Estimated Use of Generic ICR by Partnership Programs

Table 6-2	Estimated Number of Annual Respondents and Annual Burden

Table 6-3	Estimated Annual Respondent Burden and Cost

Table 6-4	Estimated Annual Agency Burden and Cost

Table 6-5	Total Estimated Annual Respondents and Burden Hours (Annual
and Three-Year) by Sector

Table 6-6	Total Estimated Annual and Three-Year Costs by Sector

Table 6-7	Total Estimated Annual Burden Hours and Costs for Respondents
and EPA

Table 6-8	Total Estimated Three-Year Burden Hours and Costs for
Respondents and EPA

U.S. ENVIRONMENTAL PROTECTION AGENCY

ASSESSMENT OF EPA PARTNERSHIP PROGRAMS

1.  Identification of the Information Collection

1(a) 	Title of the Information Collection: Assessment of EPA Partnership
Programs. EPA ICR # 2225.01

1(b) 	Short Characterization/Abstract

	The Environmental Protection Agency (EPA) is seeking approval for a
three-year generic clearance from the Office of Management and Budget
(OMB) to collect data to be used for performance measurement of EPA
Partnership Programs.

	This will be a voluntary collection of information to assess the
results arising from activities conducted by partners in EPA Partnership
Programs. The proposed generic measurement ICR will involve voluntary
collections of information via surveys to assess the activities of EPA
Partnership Programs. Performance measurement data collected will detail
awareness of associated environmental activities, behavior change, and
associated environmental benefits. EPA proposes to use electronic
surveys and questionnaires to assess activities for program purpose and
design, strategic planning, program management, and program results to
determine if the goals of the program are being met.

	The affected audience for this ICR includes participants in all of
EPA’s Partnership Programs, including businesses, governments, and
members of the community.

	Similar to the OECA generic ICR for Assessment of Compliance Assistance
Projects (EPA ICR 1869.02), this generic ICR will streamline the ability
of the 90+ EPA Partnership Programs to assess activities for program
purpose and design, strategic planning, program management and program
results to determine if the goals of the program are being met. Without
this generic measurement ICR, each of the 90+ programs must develop an
individual ICR, submit it to OMB, and OMB must then review and approve
each ICR. The generic ICR will save both time and resources.

	All assessments undertaken under this ICR will follow stringent
procedures to ensure that data are collected and used properly and
efficiently. This ICR will provide anecdotal data for the purpose of
informing EPA of the perceived effectiveness of partnership programs and
will also allow partnership programs to collect data on the
environmental results of partner activities due to participation. The
information collection is voluntary, and will be limited to
non-sensitive data concerning participation in partnership programs.

	This process does not involve fact-finding for the purposes of
regulatory development or enforcement.

	EPA estimates that a combination of surveys (electronic, mail, and
telephone) will generate voluntary responses from approximately 16,000
respondents for an estimated burden of 34,668 hours over a three-year
period. EPA anticipates that use of this generic ICR will increase over
the course of three years, and the burden will grow each year.

2. 	Need for and Use of the Collection

2(a)	Need/Authority for the Collection

	To help fulfill the broad mandate of protecting human health and the
environment, EPA works with businesses, communities, state and local
governments, and other organizations to achieve environmental goals
through partnership programs. Partnership programs provide organizations
with the information and assistance necessary to achieve and maintain
various environmental goals.

	EPA believes that measuring the performance of partnership programs is
compulsory to ensure that partnership programs are reaching the intended
audience, providing valuable resources, and achieving the desired
environmental results. Understanding this will allow EPA to better
design and manage these partnership programs to meet the needs of the
participants and to meet EPA’s environmental goals. A generic
measurement ICR will significantly increase the ability of EPA
Partnership Programs to: obtain sound program performance data to
determine and evaluate the effectiveness of these partnership programs
as well as help the programs obtain data to successfully complete PART
reviews; increase the consistency of program performance data as an
alternative/adjunct to traditional regulatory approaches for achieving
environmental results; minimize approval burden on OMB as submissions
will be shorter and of higher quality via the generic measurement ICR
process; and reduce burden on potential respondents by limiting the
number of requests for information.

2(b)	Practical Utility/Uses of the Data

	EPA believes program measurement is a requirement of a well-managed
program. The feedback will help the Agency: assess activities for
program purpose and design, strategic planning, program management and
program results to determine if the goals of the program are being met.

	This ICR only supports program assessments, which describe
accomplishments, yet make no broad generalizations or claims. The ICR
will not be used to make generalizations to overall populations (e.g.,
industry sectors or geographic regions). The ICR does not involve
“fact-finding” for the purposes of regulatory development or
enforcement, and the information obtained will not be used to make major
policy decisions. Additionally, no sensitive data will be collected
under this ICR.

	After the partnership programs collect data under each survey, the
responses will be reported to OPEI as specified in section 5(b).
Following analysis, the synthesized findings will be shared with the
appropriate Agency offices, which may use them to:

Develop baseline data on existing partner practices prior to
participation in the partnership program.

Perform program evaluation to increase program effectiveness, including
collecting ideas or suggestions for improvement of program services
(e.g., helplines, publications) from the people who use them.

Assess the current value of a program to participants for use in future
program recruiting materials and to assess perceived benefits of the
program compared with expenditures.

Identify topics on which to develop additional resources.

Assess changes in behavior and environmental results to inform EPA
management and stakeholders of success and gauge program effectiveness.

		EPA anticipates that the results of partnership program assessments
will lead to increased participation in and improved effectiveness of
the partnership programs. Ultimately, these changes could result in
increased environmental results as the programs are tailored to best
meet the needs of the participants.

3.  Non-duplication, Consultations, and Other Collection Criteria

3(a) 	Non-duplication

EPA will evaluate performance of partnership programs, including
materials produced, educational/outreach activities, and environmental
results from partner participation. The information collected through
this ICR will not overlap with other EPA surveys.

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

On July 10, 2006, EPA published a pre-ICR Federal Register Notice
announcing its intent to submit an ICR to OMB regarding the measurement
of partnership programs. EPA received one comment; however it was not
relevant to the scope of this proposed ICR.

3(c)	Consultations

EPA has received feedback on this information collection from key
stakeholders including:

EPA Partnership Program managers and staff who could make use of the ICR

Managers of the OECA and OPEI customer service ICR

EPA’s Evaluation Support Division, which conducted a review of the
draft questions

Steve Balling, Del Monte, Partner in the Pesticide Environmental
Stewardship Program

Rick Loughery, Edison Electric Institute, Partner in the Pesticide
Environmental Stewardship Program

Rob Lawson, North American Green, Partner in the GreenScapes Program

3(d) 	Effects of Less Frequent Data Collection

	EPA anticipates that partnership programs will reassess their
partners’ activities every other year. In most cases, programs will
only reassess one time during the three-year clearance; therefore this
information collection could not be conducted less frequently.

3(e) 	General Guidelines

This ICR complies with OMB’s general guidelines for the collection of
information.

3(f)	Confidentiality

No confidential data will be collected.

3(g) 	Sensitive Questions

No sensitive data will be collected.

4.  The Respondents and the Information Requested

4(a)	Respondents/SIC Codes

	For this ICR, the term “respondents” refers to individuals who
provide feedback on EPA’s Partnership Programs and activities.
Potential respondents include all partnership program participants
including businesses, governments, and members of the community.

4(b)	Information Requested

Data items, including record keeping requirements

	Information requested by surveys developed under this ICR will be used
to assess partnership programs.  Each survey will request specific
information related to the partnership program being evaluated.  EPA
offers more than 90 partnership programs to a wide range of audiences.
Section 1(b) identifies the general types of questions that will be
asked in the surveys. Surveys developed under this ICR will be limited
to those types of questions. See Attachment A for the list of questions.

		For purposes of this generic ICR, EPA assumed the following three
types of surveys will be used to assess partnership programs:

Level 1—Awareness Survey: This type of survey would include general
questions about the participating organization and questions to
determine changes in awareness of environmental issues as a result of
participation in the partnership program.

Level 2—Awareness and Behavior Survey: This type of survey would
include general questions about the participating organization and
awareness of environmental issues along with questions to measure
behavior change.

Level 3—Awareness, Behavior, and Environmental Results Survey: This
type of survey would include behavioral change questions as mentioned
above as well as environmental results and cost savings data. This
survey would require respondents to track and collect some data.

Respondent activities

	As part of this ICR, respondents will review survey forms, collect data
as necessary, answer questions, and submit survey forms to EPA.

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

5(a) 	Agency Activities

	Agency activities associated with the collection of information on
partnership programs may include:

Developing individual surveys

Disseminating questionnaires to respondents

Gathering information from respondents

Filtering/screening response data obtained through Internet feedback
screens

Reviewing data

Preparing findings

Storing and maintaining results

Adjusting partnership program activities based on assessment results

5(b)		Collection Methodology and Management

		An internal review and oversight process, independent of the
originating program office, has been established for all assessment
activities conducted under this ICR. Prior to initiating an assessment,
each program will provide to OPEI a memo with the following information:

Title, identification of originator, and appropriate contact
information.

Summary and description of the intended purpose as it relates to the
mission of EPA’s Partnership Programs.

Delivery method (e.g., electronic/mail/fax, phone), collection schedule,
and follow up plans.

Planned use of information collected.

Number of respondents, and burden in costs and hours to respondents and
the Agency.

		OPEI will submit surveys to OMB for a 10-business day expedited review
and determination. A summary including title, sponsoring office, number
of respondents, and estimated burden hours and costs will be attached.
Following the completion of assessment activities, all offices will
provide copies of their approved assessment tool, analytical reports,
and a description of any follow up actions to OPEI. The Agency will
maximize the efficiency of information collection by making every effort
to improve response rates to assessment activities.

5(c)		Small Entity Flexibility

		All data collected under this ICR are voluntarily reported. EPA
expects that some of the participants in EPA Partnership Programs will
be small entities. EPA has designed this generic ICR to minimize
respondent burden while obtaining sufficient and accurate information.

5(d)		Collection Schedule

This will be dependent upon the needs of each originator of a survey.
Schedules for surveys will be documented by the survey sponsors.

6. 		Estimating the Burden and Cost of the Collection

6(a)		Estimating Respondent Burden

		Respondent activities are expected to include only a few steps:
reviewing instructions, responding to surveys, and sending (via mail,
e-mail, or telephone) responses. To minimize the respondent burden, EPA
will use simple, clear survey designs that are easy to respond to and
are of limited scope. There will be no requirement for respondents to
develop data gathering systems, train personnel, or maintain records.
However, respondents might need to collect and track some data.

		EPA expects the burden associated with this ICR to grow over the
course of three years. This is due to several reasons. First, many
partnership programs have existing ICRs in place and may not need to use
the generic ICR until they are due for renewal. Second, as EPA
Partnership Program staff become more familiar with the generic ICR,
OPEI anticipates that more programs will begin using it. Table 6-1 below
presents the estimated use of this generic ICR by partnership programs
over the course of three years. Over the course of these three years,
participants in those partnership programs will be asked to submit
information.

Table 6-1 Estimated Use of Generic ICR by Partnership Programs

Year 1	10 programs

Year 2	25 programs

Year 3	35 programs

	To determine the total number of respondents, EPA assumed that its
smaller partnership programs (with 200 or fewer participants) would be
most likely to use the generic ICR. Based on that assumption, EPA
anticipates the number of respondents and the associated annual burden
listed in table 6-2. In the first year, EPA estimates feedback from
approximately 2,000 respondents for an estimated burden of 4,334 hours.
In the second year, EPA estimates feedback from approximately 5,000
respondents for an estimated burden of 10,834 hours. In the third year,
EPA estimates feedback from approximately 9,000 respondents for an
estimated burden of 19,500 hours. In addition, those partnership
programs that will use the generic ICR in year 1 will most likely
reassess participant activities in year 3.

Table 6-2 Estimated Number of Annual Respondents	and Annual Burden

	Respondents	Burden Hours/Year

Year 1	2,000 respondents	4,334 hours

Year 2	5,000 respondents	10,834 hours

Year 3	9,000 respondents	19,500 hours

Total	16,000 respondents	34,668 hours

		Table 6-3 presented below, present the annual respondent burden and
cost estimates. These estimates are based on OPEI’s knowledge of
surveys conducted under various partnership programs’ ICRs and
experience with similar performance measurement surveys used under
OECA’s generic ICR for Compliance Assistance Measurement (EPA ICR
1869.02).

		Using a list of pre-determined questions, partnership programs are
able to select the questions they are interested in using. There are
different types of questions geared at gauging awareness, behavior
change, and measurement of partnership programs. Partnership programs
using the generic ICR may select from these questions to design a
tailored questionnaire for their specific needs. Partnership programs
will also have the option of customizing the answer choices for the
questions they choose to use.

		Table 6-3 presents the total annual estimated respondent burden and
cost for each information collection activity, broken down by survey
type.

Table 6-3 Estimated Annual Respondent Burden and Cost

Information Collection Activity	Hours and Costs Per Respondent	Total
Hours and Costs

 	Manager	Technical	Clerical	Respond Hours/Year	Labor Costs per Year
No. of Respond./ Activities	Total Respond. Hours/Year	Total Cost/Year

Hourly Rate	79.49	64.80	34.86

Awareness Survey

Review survey form	 	0.1	 	0.1	$6	1777.8	178	$11,520

Answer general questions to measure awareness	 	0.3	 	0.3	$19	1777.8
533	$34,560

Submit form	 	0.1	 	0.1	$6	1777.8	178	$11,520

Subtotal	 	0.5	 	0.5	$32	 	889	$57,601

Awareness and Behavior Survey

Review survey form	 	0.1	 	0.1	$6	1777.8	178	$11,520

Answer questions to measure awareness/behavior change	 	0.5	 	0.5	$32
1777.8	889	$57,601

Management review	0.3	 	 	0.3	$24	1777.8	533	$42,395

Submit form	 	0.1	 	0.1	$6	1777.8	178	$11,520

Subtotal	0.3	0.7	0	1	$69	 	1,778	$123,036

Awareness, Behavior, and Environmental Results Survey

Review survey form	 	0.1	 	0.1	$6	1777.8	178	$11,520

Collect data for environmental results	 	3.8	 	3.8	$246	1777.8	6,756
$437,765

Answer questions to measure awareness/behavior change and to illustrate
environmental results	 	0.5	 	0.5	$32	1777.8	889	$57,601

Management review	0.5	 	 	0.5	$40	1777.8	889	$70,659

Submit form	 	0.1	 	0.1	$6	1777.8	178	$11,520

Subtotal	0.5	4.5	0	5.0	$331	 	8,889	$589,065

TOTAL	0.8	5.7	0	6.6	439.432	 	11,556	$769,702

6(b)		Estimating Respondent Costs

		In order to minimize the respondent burden, survey designs will be
simple, convenient, easy to respond to, and clear in content and
purpose. Surveys will be of limited scope and require only a short time
to complete.

		(i)	Estimating Labor Costs

		The labor rates used to determine the estimated costs to respondents
are consistent with the hourly wage rates published by the Bureau of
Labor Statistics publications on employment and earnings. Rates include
the cost of overhead and fringe benefits. EPA estimates an average
respondent hourly labor rate (hourly plus overhead) of $79.49 for
managerial staff, $64.80 for technical staff, and $34.86 for clerical
staff.

		(ii)	Estimating Capital and Operations and Maintenance Costs

		Activities supported by this ICR do not involve the purchase of
monitoring or reporting equipment.

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

		Activities supported by this ICR do not involve the purchase of
monitoring or reporting equipment.

		(iv)	Annualizing Capital Costs

		Not applicable.

6(c)	 	Estimating Agency Burden and Cost

		Table 6-4 provides the annual estimates for EPA burden and cost
associated with developing and disseminating surveys and analyzing the
results. EPA used its experience implementing other partnership programs
to estimate burden estimates for Agency staff. The hourly labor rates
used to determine the estimated costs to the Agency are consistent with
annual labor rates published in the Federal Register and are based on
the 2004 GS pay schedule available from the Office of Personnel
Management. EPA estimates an average hourly labor cost of $62.91 for
managerial staff; $46.11 for technical staff; and $18.51 for clerical
staff. The labor costs are based on the following GS levels and steps:
managerial rates were based on GS Level 14, Step 4; technical labor
rates were based on GS Level 12 Step 5; and clerical labor rates were
based on GS Level 5, Step 1. To derive hourly estimates, EPA divided
annual compensation by 2,080—the number of hours in the Federal
work-year. EPA then multiplied hourly rates by the standard government
overhead factor of 1.6.

		Because EPA expects use of the generic ICR to increase over the course
of 3 years, in order to determine the Agency’s annual burden, EPA
assumed an average of 23.3 programs using the generic ICR each year,
with those surveys being evenly divided between the three types of
surveys.

Table 6-4 Estimated Annual Agency Burden and Cost

Information Collection Activity	Hours and Costs Per Respondent	Total
Hours and Costs

 	Manager	Technical	Clerical	Agency Hours/Year	Labor Costs per Year	No.
of Events	Total Agency Hours/Year	Total Cost/Year

Hourly Rate	62.91	46.11	18.51

Awareness Survey

Choose survey questions and response selections and develop forms	0.5	4
0.5	5	$225	7.7	38.5	$1,734

Distribute forms	 	1	1	2	$65	7.7	15.4	$498

Answer questions from respondents	 	2	 	2	$92	7.7	15.4	$710

Review completed submissions and enter into database, as necessary	 	8
2	10	$406	7.7	77	$3,125

Perform quality control	1	4	 	5	$247	7.7	39	$1,905

Subtotal	1.5	19	3.5	24	$1,035	 	185	$7,971

Awareness and Behavior Survey

Choose survey questions and response selections and develop forms	0.5	6
0.5	7	$317	7.7	54	$2,444

Distribute forms	 	1	1	2	$65	7.7	15	$498

Answer questions from respondents	 	3	 	3	$138	7.7	23	$1,065

Review completed submissions and enter into database, as necessary	 	10
2	12	$498	7.7	92	$3,836

Perform quality control	1	4	 	5	$247	7.7	39	$1,905

Subtotal	1.5	24	3.5	29	$1,266	 	223	$9,747

Awareness, Behavior, and Environmental Results Survey

Choose survey questions and response selections and develop forms	1	8	1
10	$450	7.7	77	$3,467

Distribute forms	 	1	1	2	$65	7.7	15	$498

Answer questions from respondents	 	4	 	4	$184	7.7	31	$1,420

Review completed submissions and enter into database, as necessary	 	12
4	16	$627	7.7	123	$4,831

Perform quality control	1	5	 	6	$293	7.7	46	$2,260

Subtotal	1	30	6	38	$1,327	 	293	$12,475

TOTAL	4	73	13	91	3627.75	 	700.7	$30,193.32

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

		EPA estimates that over the three-year life of the umbrella clearance,
16,000 respondents will voluntarily respond to partnership program
assessments conducted under this ICR for a total burden of 34,668 hours
and a total cost of $2,309,106.

		EPA expects the primary respondents for this ICR to be state, local,
and tribal governments and the private sector. EPA estimates that
approximately one-third of the respondents (5,333 respondents) will be
from the state and local government sector and that two-thirds of the
respondents (10,667 respondents) will be from the private sector. The
hour burden and costs for each respondent is assumed to be the same
regardless of sector. Table 6-5 summarizes the total estimated annual
respondents for each sector and their estimated burden hours annually
and over three years. Table 6-6 summarizes the total estimated annual
and three-year costs by sector.

Table 6-5 Total Estimated Annual Respondents and Burden Hours (Annual
and Three-Year) by Sector

Respondents	Respondents/Year	Burden Hours/Year	Respondents over Three
Years	Total Burden Hours over Three Years

State, local, and tribal government	1,778	3,852	5,333	11,556

Private Sector	3,556	7,704	10,667	23,112

Table 6-6 Total Estimated Annual and Three-Year Costs by Sector

Respondents	Total Labor Costs/Year	Total Capital/O&M Costs/Year	Total
Costs/Year	Total Costs over Three Years

State, local, and tribal government	$256,567	$0	$256,567	$769,701

Private sector	$513,135	$0	$513,135	$1,539,405

6(e)		Bottom Line Burden Hours and Cost Tables

		Table 6-7 summarizes the total estimated annual burden hours and costs
for respondents and for the Agency. The total annual cost for
respondents is $769,702 and the hourly burden is approximately 11,556.
The total annual cost for the Agency is $30,193 and the hourly burden is
approximately 701. Table 6-5 displays these combined estimates, as well
as the grand total of $799,895 and the hourly burden of 12,257 hours for
all information collection activities under this generic ICR.

Table 6-7 Total Estimated Annual Burden Hours and Costs for Respondents
and EPA

	Burden Hours/Year	Total Labor Costs/Year	Total Capital /O&M Costs/Year
Total Cost/Year

Respondents	11,556	$769,702	$0	$769,702

EPA	701	$30,193	$0	$30,193

TOTAL	12,257	$799,895	$0	$799,895

		Table 6-8 summarizes the total estimated three-year burden hours and
costs for respondents and for the Agency. The total three-year cost for
respondents is $2,309,106 and the hourly burden is approximately 34,668.
The total three-year cost for the Agency is $90,579 and the hourly
burden is approximately 2,103.

Table 6-8 Total Estimated Three Year Burden Hours and Costs for
Respondents and EPA

	Burden Hours	Total Labor Costs/Year	Total Capital/O&M Costs/Year	Total
Cost

Respondents	34,668	$2,309,106	$0	$2,309,106

EPA	2,103	$90,579	$0	$90,579

TOTAL	36,771	$2,399,685	$0	$2,399,685

6(f)		Reasons for Change in Burden

		This ICR does not modify an existing ICR.

6(g) 		Burden Statement

		The estimated average annual respondent reporting and recordkeeping
burden for this collection of information is 2.2 hours. Burden means the
total time, effort, or financial resources expended by persons to
generate, maintain, retain, or disclose or provide information to or for
a Federal Agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information; adjust
the existing ways to comply with any previously applicable instructions;
search data sources; complete and review the collection of information;
and transmit or otherwise disclose the information. An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number. The OMB control numbers for EPA’s regulations are
listed in 40 CFR Part 9 and 48 CFR Chapter 15.

		To comment on the Agency’s need for this information, the accuracy
of the provided burden estimates, and any suggested methods for
minimizing respondent burden, including the use of automated collection
techniques,  EPA has established a public docket for this ICR under
Docket ID Number EPA-HQ-OA-2006-0566, which is available for online
viewing at  www.regulations.gov,  or in person viewing at the
Enforcement and Compliance  Docket and  Information Center in the EPA
Docket Center (EPA/DC),  EPA West, Room B102, 1301 Constitution Avenue,
NW, Washington, DC  The EPA Docket Center Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays.  The telephone number for the Reading Room is<PHONE_NUMBER>,
and the telephone number for the Enforcement and Compliance Docket and
Information Center is<PHONE_NUMBER>.  An electronic version of the
public docket is available through EPA Dockets www.regulations.gov.
This site can be used to submit or view public comments, access the
index listing of the contents of the public docket and to access those
documents in the public docket that are available electronically.  When
in the system, select “search,” then key in the Docket ID number
identified above.  You can also send comments to the Office of
Information and Regulatory Affairs, Office of Management and Budget, 725
17th Street, NW, Washington, DC 20503, Attention Desk Officer for EPA.
Please include the EPA Docket Number:  EPA-HQ-OA-2006-0566 in any
correspondence.

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[Federal Register Volume 77, Number 7 (Wednesday, January 11, 2012)]
[Notices]
[Pages 1674-1676]
[FR Doc No: 2012-274]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP12-28-000]

Tennessee Gas Pipeline Company, L.L.C.; Notice of Intent To
Prepare an Environmental Assessment for the Proposed MPP Project and
Request for Comments on Environmental Issues

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental assessment (EA) that will
discuss the environmental impacts of the MPP Project, involving
construction and operation of facilities by Tennessee Gas Pipeline
Company, L.L.C. (TGP) in Potter, McKean, Mercer, and Venango Counties,
Pennsylvania. The Commission will use this EA in its decisionmaking
process to determine whether the project is in the public convenience
and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies on the project. Your input will help the Commission staff
determine what issues they need to evaluate in the EA. Please note that
the scoping period will close on February 3, 2012. At this time you may
submit comments in written form.

    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable agreement. However, if
the Commission approves the project, that approval conveys with it the
right of eminent domain. Therefore, if easement negotiations fail to
produce an agreement, the pipeline company could initiate condemnation
proceedings where compensation would be determined in accordance with
state law.
    TGP provided landowners with a fact sheet prepared by the FERC
entitled ``An Interstate Natural Gas Facility On My Land? What Do I
Need To Know?'' This fact sheet addresses a number of typically-asked
questions, including the use of eminent domain and how to participate
in the Commission's proceedings. It is also available for viewing on
the FERC Web site (www.ferc.gov).

Summary of the Proposed Project

    TGP proposes to construct and operate 7.9 miles of looped \1\ 30-
inch-diameter pipeline and facility modifications in northern
Pennsylvania. The MPP Project would provide about 240,000 dekatherms of
natural gas per day to markets in Ohio and Tennessee. According to TGP,
its project would provide access to newly developed and diversified
sources of natural gas in the eastern United States.
---------------------------------------------------------------------------

    \1\ A pipeline loop is a segment of pipe constructed parallel to
an existing pipeline to increase capacity.
---------------------------------------------------------------------------

    The MPP Project would consist of the following components:
     Installation of 7.9 miles of 30-inch-diameter pipeline in
Potter County, designated as Loop 313;
     Miscellaneous aboveground equipment including a pig
launcher; \2\ and
---------------------------------------------------------------------------

    \2\ A ``pig'' is a tool that the pipeline company inserts into
and pushes through the pipeline for cleaning the pipeline,
conducting internal inspections, or other purposes.
---------------------------------------------------------------------------

     Facility modifications at the following four compressor
stations to provide bi-directional natural gas flow:
    a. Station 219, in Mercer County;
    b. Station 303, in Venango County;
    c. Station 310, in McKean County; and
    d. Station 313, in Potter County.
    The general location of the project facilities is shown in Appendix
1.\3\
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    \3\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of appendices were sent to all those
receiving this notice in the mail and are available at www.ferc.gov
using the link called ``eLibrary'' or from the Commission's Public
Reference Room, 888 First Street NE., Washington, DC 20426, or call
(202) 502-8371. For instructions on connecting to eLibrary, refer to
the last page of this notice.
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Land Requirements for Construction

    Construction of the proposed facilities would disturb about 236
acres of land for the aboveground facilities and the pipeline.
Following construction, TGP would maintain about 49 acres for permanent
operation of the project's facilities; the remaining acreage would be
restored and revert to former uses. As proposed, the pipeline route
parallels TGP's existing 300 Line right-of-way for the majority of its
length.

The EA Process

    The National Environmental Policy Act (NEPA) requires the
Commission to take into account the environmental impacts that could
result from an action whenever it considers the issuance of a
Certificate of Public Convenience and Necessity. NEPA also requires us
\4\ to discover and address concerns the public may have about
proposals. This process is referred to as ``scoping.'' The main goal of
the scoping process is to focus the analysis in the EA on the important
environmental issues. By this notice, the Commission requests public
comments on the scope of the issues to address in the EA. We will
consider all filed comments during the preparation of the EA.
---------------------------------------------------------------------------

    \4\ ``We,'' ``us,'' and ``our'' refer to the environmental staff
of the Commission's Office of Energy Projects.
---------------------------------------------------------------------------

    In the EA we will discuss impacts that could occur as a result of
the construction and operation of the proposed project under these
general headings:
     Geology and soils;
     Land use and cumulative impacts;
     Water resources, fisheries, and wetlands;
     Cultural resources;
     Vegetation and wildlife;
     Air quality and noise;
     Endangered and threatened species; and
     Public safety.
    We will also evaluate reasonable alternatives to the proposed
project or portions of the project, and make recommendations on how to
lessen or avoid impacts on the various resource areas.
    The EA will present our independent analysis of the issues. The EA
will be available in the public record through eLibrary. Depending on
the comments received during the scoping process, we may also publish
and distribute the EA to the public for an allotted comment period. We
will consider all comments on the EA before making our recommendations
to the Commission. To ensure we have the opportunity to consider and
address your comments, please carefully follow the instructions in the
Public Participation section below.
    With this notice, we are asking agencies with jurisdiction by law
and/or special expertise with respect to the environmental issues of
this project to formally cooperate with us in the preparation of the
EA.\5\ Agencies that would like to request cooperating agency status
should follow the instructions for filing comments provided under the
Public Participation section of this notice.
---------------------------------------------------------------------------

    \5\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Part 1501.6.
---------------------------------------------------------------------------

Consultations Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, we are using this notice to initiate consultation
with applicable State Historic Preservation Office (SHPO), and to
solicit their views and those of other government agencies, interested
Indian tribes, and the public on the project's potential effects on
historic properties.\6\ We will define the project-specific Area of
Potential Effects (APE) in consultation with the SHPO as the project
develops. On natural gas facility projects, the APE at a minimum
encompasses all areas subject to ground disturbance (examples include
construction right-of-way, contractor/pipe storage yards, compressor
stations, and access roads). Our EA for this project will document our
findings on the impacts on historic properties and summarize the status
of consultations under section 106.
---------------------------------------------------------------------------

    \6\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.
---------------------------------------------------------------------------

Public Participation

    You can make a difference by providing us with your specific
comments or concerns about the project. Your comments should focus on
the potential environmental effects,

reasonable alternatives, and measures to avoid or lessen environmental
impacts. The more specific your comments, the more useful they will be.
To ensure that your comments are timely and properly recorded, please
send your comments so that the Commission receives them in Washington,
DC on or before February 3, 2012.
    For your convenience, there are three methods which you can use to
submit your comments to the Commission. In all instances please
reference the project docket number (CP12-28-000) with your submission.
The Commission encourages electronic filing of comments and has expert
staff available to assist you at<PHONE_NUMBER> or<EMAIL_ADDRESS>    (1) You can file your comments electronically using the eComment
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. This is an easy method for interested persons to
submit brief, text-only comments on a project;
    (2) You can file your comments electronically using the eFiling
feature on the Commission's Web site (www.ferc.gov) under the link to
Documents and Filings. With eFiling, you can provide comments in a
variety of formats by attaching them as a file with your submission.
New eFiling users must first create an account by clicking on
``eRegister.'' You must select the type of filing you are making. If
you are filing a comment on a particular project, please select
``Comment on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the following address:

Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street NE., Room 1A, Washington, DC 20426.

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project. We will update the environmental mailing list
as the analysis proceeds to ensure that we send the information related
to this environmental review to all individuals, organizations, and
government entities interested in and/or potentially affected by the
proposed project.
    If we publish and distribute the EA, copies will be sent to the
environmental mailing list for public review and comment. If you would
prefer to receive a paper copy of the document instead of the CD
version or would like to remove your name from the mailing list, please
return the attached Information Request (Appendix 2).

Becoming an Intervenor

    In addition to involvement in the EA scoping process, you may want
to become an ``intervenor'' which is an official party to the
Commission's proceeding. Intervenors play a more formal role in the
process and are able to file briefs, appear at hearings, and be heard
by the courts if they choose to appeal the Commission's final ruling.
An intervenor formally participates in the proceeding by filing a
request to intervene. Instructions for becoming an intervenor are in
the User's Guide under the ``e-filing'' link on the Commission's Web
site.

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site at www.ferc.gov using the ``eLibrary'' link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number,
excluding the last three digits in the Docket Number field (i.e., CP12-
28). Be sure you have selected an appropriate date range. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission now offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/esubscribenow.htm.
    Finally, public meetings or site visits will be posted on the
Commission's calendar located at www.ferc.gov/EventCalendar/EventsList.aspx along with other related information.

    Dated: January 4, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-274 Filed 1-10-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 61 (Wednesday, March 30, 2022)]
[Notices]
[Pages 18470-18471]
[FR Doc No: 2022-06683]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2022-0029]

Denial of Motor Vehicle Defect Petition, DP21-005

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Denial of petition for a defect investigation.

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

SUMMARY: This notice sets forth the reasons for the denial of a
petition submitted on September 27, 2021, by Mr. James Lamb to NHTSA's
Office of Defects Investigation (ODI). The petition requests that the
Agency initiate an investigation into alleged ``defects in the 2006
J1939 databus,'' citing a 2016 research paper published through the
University of Michigan. On December 23, 2021, NHTSA opened Defect
Petition DP21-005 to evaluate the petitioner's request. After reviewing
the information provided by the petitioner regarding the alleged defect
and conducting searches of complaints from vehicle owners, operators,
and fleet supervisors, NHTSA has concluded that there is insufficient
evidence to warrant further action at this time. Accordingly, the
Agency has denied the petition.

FOR FURTHER INFORMATION CONTACT: Mr. Ryan Rahimpour, Medium and Heavy-
Duty Vehicle Defects Division, Office of Defects Investigation, NHTSA,
1200 New Jersey Ave. SE, Washington, DC 20590 (telephone<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

1.0 Introduction

    Pursuant to 49 CFR 552.1, interested persons may petition NHTSA
requesting that the Agency initiate an investigation to determine
whether a motor vehicle or item of replacement equipment fails to
comply with applicable motor vehicle safety standards or contains a
defect that relates to motor vehicle safety. 49 U.S.C. 30162; 49 CFR
part 552. Upon receipt of a properly filed petition, the Agency
conducts a technical review of the petition, material submitted with
the petition, and any additional information. 49 U.S.C. 30162(c); 49
CFR

552.6. After the technical review and considering appropriate factors,
which may include, among other factors, Agency priorities, and the
likelihood of success in litigation that might arise from a
determination of a noncompliance or a defect related to motor vehicle
safety, the Agency will grant or deny the petition. 49 U.S.C. 30162(d);
49 CFR 552.8.

2.0 Petition

    Mr. James Lamb (the petitioner), Executive Director of the Small
Business in Transportation Coalition (SBTC), submitted a petition to
NHTSA on September 27, 2021. The petition requested NHTSA to initiate a
defect investigation into the potential hacking susceptibility of the
Society of Automotive Engineers (SAE) J1939 Data Bus standard.
    In support of the petition, the petitioner cited a 2016 study from
University of Michigan (Michigan) researchers, entitled Truck Hacking:
An Experimental Analysis of the SAE J1939 Standard, which alleges a SAE
J1939 Data Bus vulnerability in a Model Year (MY) 2001 school bus and a
MY 2006 Class-8 semi-tractor.\1\ The study alleges that, due to the
vulnerability, vehicle critical safety functions such as the
accelerator control or braking systems are susceptible to unauthorized
access and control, increasing motor vehicle safety risks. The petition
includes no other specification with respect to affected makes or
models of vehicles with the alleged safety defect.
---------------------------------------------------------------------------

    \1\ Burakova, Y., Hass, B., Millar, L., Weimerskirch, A.,
(2016). Truck Hacking: An Experimental Analysis of the SAE J1939
Standard. woot16-paper-burakova.pdf (usenix.org).
---------------------------------------------------------------------------

3.0 Analysis

    On December 23, 2021, ODI opened Defect Petition Investigation
DP21-005 to evaluate the petitioner's request. In evaluating the
petition, ODI reviewed the cited University of Michigan study to
understand and determine the scope and feasibility of the alleged
defect and reviewed the NHTSA database for similar complaints.
    The petitioner did not specify the make and model of the vehicles
with the alleged safety defect. The only categories of relevant subject
vehicles specified were found in the Michigan study: MY 2001 school
buses and MY 2006 Class-8 semi-tractors.
    After reviewing the available information and using ODI's risk-
based processes, ODI has not identified evidence that would support
opening a defect investigation into the subject vehicles. The vehicle
vulnerabilities reported in the Michigan study required physical access
to the J1939 connector in order to affect vehicle critical safety
functions such as the accelerator control or braking systems. Whether
there is a potential for remote compromise is a factor that NHTSA has
considered in evaluating the likelihood or frequency of a potential
safety defect. The Michigan study did not demonstrate a remote
compromise of these vehicles. In addition, based on the age of the
subject model year school buses and semi-tractors, they do not have
over-the-air software update capabilities or an internet connection to
make remote compromise possible.
    ODI conducted a search for similar complaints received by the
Agency and found no complaints of any type related to this alleged
vulnerability, aside from the Petition. This evaluation included
searches of complaints from vehicle owners, operators, and fleet
supervisors. ODI has not found any similar events, complaints, or
allegations suggesting a real-life vulnerability based on the available
information. Therefore, given a thorough analysis of the potential for
finding a safety-related defect in the subject vehicles, and in view of
NHTSA's enforcement priorities, a defects investigation is unlikely to
result in a finding that a defect related to motor vehicle safety
exists.

4.0 Conclusion

    NHTSA is authorized to issue an order requiring notification and
remedy of a defect if the Agency's investigation shows a defect in the
design, construction, or performance of a motor vehicle that presents
an unreasonable risk to safety. 49 U.S.C. 30102(a)(9), 30118. Given
that the existing information does not provide evidence of a real-life
vulnerability in the alleged subject vehicles, caused by a vehicle-
based defect, it is unlikely that an order concerning the notification
and remedy of a safety-related defect would be issued due to any
investigation opened upon grant of this petition. Therefore, and upon
full consideration of the information presented in the petition and the
potential risks to safety, the petition is denied. The denial of this
petition does not foreclose the Agency from taking further action if
warranted or making a future finding that a safety-related defect
exists based upon additional information the Agency may receive.
    Authority: 49 U.S.C. 30162(d); delegations of authority at CFR 1.95
and 501.8.

Anne L. Collins,
Associate Administrator for Enforcement.
[FR Doc. 2022-06683 Filed 3-29-22; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register: October 25, 2011 (Volume 76, Number 206)]
[Notices]
[Page 66072-66073]
[DOCID:fr25oc11-77]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0159]

Albert Ronald Cioffi: Debarment Order

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is issuing an order
under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
Albert Cioffi, MD for 5 years from providing services in any capacity
to a person that has an approved or pending drug product application.
FDA bases this order on findings that Dr. Cioffi was convicted of a
misdemeanor under Federal law for conduct relating to the regulation of
a drug product under the FD&C Act and that the type of conduct
underlying the conviction undermines the process for the regulation of
drugs. Dr. Cioffi was given notice of the proposed debarment and an
opportunity to request a hearing within the timeframe prescribed by
regulation. Dr. Cioffi failed to request a hearing. Dr. Cioffi's
failure to request a hearing constitutes a waiver of his right to a
hearing concerning this action.

DATES: This order is effective October 25, 2011.

ADDRESSES: Submit applications for termination of debarment to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Kenny Shade, Division of Compliance
Policy, Food and Drug Administration, 12420 Parklawn Dr., Element
Bldg., rm. 4144, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C.
335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds
that the individual has been convicted of a misdemeanor under Federal
law for conduct relating to the regulation of a drug product under the
FD&C Act, and if FDA finds that the type of conduct that served as the
basis for the conviction undermines the process for the regulation of
drugs.
    On January 9, 2008, based upon a plea of guilty to one count of
misbranding a drug while held for sale after shipment in interstate
commerce, in violation of 21 U.S.C. 331(k), 333(a)(1), and

352(i)(3), judgment was entered against Dr. Cioffi in the United States
District Court for the Southern District of Florida.
    FDA's finding that debarment is appropriate is based on the
misdemeanor conviction referenced herein. The factual basis for the
conviction is as follows: During 2004, Dr. Cioffi was a physician
licensed to practice in the State of Florida. In February 2004, Dr.
Cioffi became the medical doctor of Body Rx, a medical office located
in Boca Raton, FL. In July 2004, Dr. Cioffi became the sole owner of
Body Rx which specialized in cosmetic procedures, including the
treatment of forehead wrinkles. When Dr. Cioffi began working at Body
Rx, he learned that Body Rx had been treating patients for forehead
wrinkles with the unapproved drug derived from Botulinum Toxin Type A
(TRI-toxin), sold by Toxin Research International (TRI), a company in
Tuscon, AZ. Dr. Cioffi spoke with TRI representatives and learned that
TRI-toxin was not approved by FDA for treatment of facial wrinkles.
Nonetheless, Dr. Cioffi continued to purchase and use the unapproved
drug from TRI. On four separate occasions between February and November
of 2004, Body Rx purchased a total of eight vials of unapproved TRI-
toxin at Dr. Cioffi's direction. Dr. Cioffi used the unapproved drug to
inject approximately 30 patients and never informed these patients that
they were receiving an unapproved version of Botulinum Toxin Type A.
Instead, Dr. Cioffi told patients that they were purchasing and being
injected with the approved BOTOX Cosmetic, and he indicated in these
patients' medical records that they were receiving the FDA approved
BOTOX Cosmetic.
    From in or about February 2004, and continuing through in or about
November 2004, in the Southern District of Florida, and elsewhere, Dr.
Cioffi did misbrand a drug, namely Botulinum Toxin Type A distributed
by TRI, while it was held for sale and after shipment in interstate
commerce, in that he offered the unapproved Botulinum Toxin Type A for
sale by injection to patients under the name of another drug, all in
violation of 21 U.S.C. 331(k), 333(a)(1), 352(i)(3), and 18 U.S.C. 2.
    As a result of his conviction, on June 1, 2011, FDA sent Dr. Cioffi
a notice by certified mail proposing to debar him for 5 years from
providing services in any capacity to a person that has an approved or
pending drug product application. The proposal was based on a finding,
under section 306(b)(2)(B)(i)(I) of the FD&C Act that Dr. Cioffi was
convicted of a misdemeanor under Federal law for conduct relating to
the regulation of a drug product under the FD&C Act, and the conduct
that served as a basis for the conviction undermines the process for
the regulation of drugs. The proposal also offered Dr. Cioffi an
opportunity to request a hearing, providing him 30 days from the date
of receipt of the letter in which to file the request, and advised him
that failure to request a hearing constituted a waiver of the
opportunity for a hearing and of any contentions concerning this
action. Dr. Cioffi failed to request a hearing within the timeframe
prescribed by regulation and has, therefore, waived his opportunity for
a hearing and waived any contentions concerning his debarment (21 CFR
part 12).

II. Findings and Order

    Therefore, the Acting Director, Office of Enforcement, Office of
Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act
under authority delegated to him (Staff Manual Guide 1410.35), finds
that Albert R. Cioffi has been convicted of a misdemeanor under Federal
law for conduct relating to the regulation of a drug product under the
FD&C Act, and that the type of conduct that served as a basis for the
conviction undermines the process for the regulation of drugs.
    As a result of the foregoing finding, Dr. Cioffi is debarred for 5
years from providing services in any capacity to a person with an
approved or pending drug product application under sections 505, 512,
or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section
351 of the Public Health Service Act (42 U.S.C. 262), effective (see
DATES), (see sections 306(c)(1)(B), (c)(2)(A)(iii), and 201(dd) of the
FD&C Act (21 U.S.C. 335a(c)(1)(B), (c)(2)(A)(iii), and 321(dd))). Any
person with an approved or pending drug product application who
knowingly employs or retains as a consultant or contractor, or
otherwise uses the services of Dr. Cioffi, in any capacity during Dr.
Cioffi's debarment, will be subject to civil money penalties (section
307(a)(6) of the FD&C Act (21 U.S.C. 335b(a)(6))). If Dr. Cioffi
provides services in any capacity to a person with an approved or
pending drug product application during his period of debarment he will
be subject to civil money penalties (section 307(a)(7) of the FD&C
Act). In addition, FDA will not accept or review any abbreviated new
drug applications submitted by or with the assistance of Dr. Cioffi
during his period of debarment (section 306(c)(1)(B) of the FD&C Act).
    Any application by Dr. Cioffi for termination of debarment under
section 306(d)(1) of the Act (21 U.S.C. 355a(d)(1)) should be
identified with Docket No. FDA-2011-N-0159 and sent to the Division of
Dockets Management (see ADDRESSES). All such submissions are to be
filed in four copies. The public availability of information in these
submissions is governed by 21 CFR 10.20(j).
    Publicly available submissions may be seen in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: October 11, 2011.
Armando Zamora,
Acting Director, Office of Enforcement, Office of Regulatory Affairs.
[FR Doc. 2011-27509 Filed 10-24-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 81, Number 74 (Monday, April 18, 2016)]
[Notices]
[Pages 22606-22608]
[FR Doc No: 2016-08881]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-1110]

Public Meeting on Patient-Focused Drug Development for
Neuropathic Pain Associated With Peripheral Neuropathy

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
a public meeting and an opportunity for public comment on Patient-
Focused Drug Development for neuropathic pain associated with
peripheral neuropathies. Patient-Focused Drug Development is part of
FDA's performance commitments made as part of the fifth authorization
of the Prescription Drug User Fee Act (PDUFA V). The public meeting is
intended to allow FDA to obtain patient perspectives on the impact of
neuropathic pain associated with peripheral neuropathies, patient views
on treatment approaches, and decision factors taken into account when
selecting a treatment.

DATES: The public meeting will be held on June 10, 2016, from 10 a.m.
to 4 p.m. Registration to attend the meeting must be received by June
3, 2016 (see SUPPLEMENTARY INFORMATION for instructions). Submit
electronic or

written comments to the public docket by August 10, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2016-N-1110 for ``Public Meeting on Patient-Focused Drug
Development for Neuropathic Pain Associated with Peripheral
Neuropathy.'' 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.
    FDA will post the agenda approximately 5 days before the meeting
at: http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 1146, Silver Spring, MD 20993-0002, 240-
402-6525, FAX:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background on Patient-Focused Drug Development

    FDA has selected neuropathic pain associated with peripheral
neuropathy as the focus of a public meeting under Patient-Focused Drug
Development, an initiative that involves obtaining a better
understanding of patient perspectives on the severity of a disease and
the available therapies for that condition. Patient-Focused Drug
Development is being conducted to fulfill FDA performance commitments
that are part of the reauthorization of the PDUFA under Title I of the
Food and Drug Administration Safety and Innovation Act (FDASIA) (Pub.
L. 112-144). The full set of performance commitments is available at
http://www.fda.gov/downloads/forindustry/userfees/prescriptiondruguserfee/ucm270412.pdf.
    FDA committed to obtain the patient perspective on at least 20
disease areas during the course of PDUFA V. For each disease area, the
Agency is conducting a public meeting to discuss the disease and its
impact on patients' daily lives, the types of treatment benefit that
matter most to patients, and patients' perspectives on the adequacy of
the available therapies. These meetings will include participation of
FDA review divisions, the relevant patient communities, and other
interested stakeholders.
    On April 11, 2013, FDA published a notice in the Federal Register
(78 FR 21613) announcing the disease areas for meetings in fiscal years
(FYs) 2013-2015, the first 3 years of the 5-year PDUFA V time frame.
The Agency used several criteria outlined in that notice to develop the
list of disease areas. FDA obtained public comment on the Agency's
proposed criteria and potential disease areas through a public docket
and a public meeting that was convened on October 25, 2012. In
selecting the set of disease areas, FDA carefully considered the public
comments received and the perspectives of review divisions at FDA. FDA
initiated a second public process for determining the disease areas for
FY 2016-2017, and published a notice in the Federal Register on July 2,
2015 (80 FR 38216), announcing the selection of eight disease areas.
More information, including the list of disease areas and a general
schedule of meetings, is posted at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm326192.htm.

II. Public Meeting Information

A. Purpose and Scope of the Meeting

    As part of Patient-Focused Drug Development, FDA will obtain
patient and patient stakeholder input on the impacts of neuropathic
pain associated with peripheral neuropathies. Peripheral neuropathy is
a neurological disorder that develops as a result of damage to the
peripheral nerves and is

associated with both a physical and psychological burden. Nerve damage
can be caused by diseases such as diabetes, physical injury, or
exposure to drugs or toxins. The pain associated with neuropathies of
sensory nerves may be characterized as a pins and needles sensation, as
sharp, jabbing, or burning, or as an exaggeratedly intense or distorted
pain response to typically nonpainful touch. While there is currently
no cure, treatments for the pain associated with peripheral neuropathy
include prescription medications and other approaches such as
transcutaneous electrical nerve stimulation, braces, and behavioral
therapies. FDA is interested in the perspectives of patients with
peripheral neuropathy on specifically: (1) The impact of neuropathic
pain associated with peripheral neuropathy and (2) treatment approaches
for the neuropathic pain associated with peripheral neuropathy.
    The questions that will be asked of patients and patient
stakeholders at the meeting are listed in this section, organized by
topic. For each topic, a brief initial patient panel discussion will
begin the dialogue. This will be followed by a facilitated discussion
inviting comments from other patient and patient stakeholder
participants. In addition to input generated through this public
meeting, FDA is interested in receiving patient input addressing these
questions through written comments, which can be submitted to the
public docket (see ADDRESSES).
Topic 1: Disease Symptoms and Daily Impacts That Matter Most to
Patients
    1. How would you describe your neuropathic pain associated with
peripheral neuropathy? What terms would you use to describe the most
bothersome aspects of pain? (Examples may include stabbing sensations,
electric shocks, burning or tingling, etc.)
    2. Are there specific activities that are important to you but that
you cannot do at all or as fully as you would like because of your
neuropathic pain? (Examples of activities may include sleeping through
the night, daily hygiene, participation in sports or social activities,
intimacy with a spouse or partner, etc.)
    3. How do your neuropathic pain and its negative impacts affect
your daily life on the best days? On the worst days?
    4. How has your neuropathic pain changed over time?
    5. What worries you most about your condition?
Topic 2: Patients' Perspectives on Current Approaches to Treatment
    1. What are you currently doing to help treat your neuropathic pain
associated with peripheral neuropathy? (Examples may include
prescription medicines, over-the-counter products, and other therapies
including non-drug therapies). How has your treatment regimen changed
over time, and why?
    2. How well does your current treatment regimen control your
neuropathic pain?
    a. How well have these treatments worked for you as your condition
has changed over time?
    b. Would you define your condition today as being well managed?
    3. What are the most significant downsides to your current
treatments, and how do they affect your daily life? (Examples of
downsides may include bothersome side effects, going to the hospital or
clinic for treatment, time devoted to treatment, restrictions on
driving, etc.)
    4. Assuming there is no complete cure for your neuropathic pain,
what specific things would you look for in an ideal treatment for your
neuropathic pain? What would you consider to be a meaningful
improvement in your condition (for example, specific symptom
improvements or functional improvements) that a treatment could
provide?
    5. If you had the opportunity to consider participating in a
clinical trial studying experimental treatments for neuropathic pain,
what things would you consider when deciding whether or not to
participate? (Examples may include how severe your neuropathic pain is,
how well current treatments are working for you, your concern about
risks, etc.)

B. Meeting Attendance and Participation

    If you wish to attend this meeting, visit https://peripheralneuropathypfdd.eventbrite.com. Please register by June 3,
2016. If you are unable to attend the meeting in person, you can
register to view a live Webcast of the meeting. You will be asked to
indicate in your registration if you plan to attend in person or via
the Webcast. Seating will be limited, so early registration is
recommended. Registration is free and will be on a first-come, first-
served basis. However, FDA may limit the number of participants from
each organization based on space limitations. Registrants will receive
confirmation once they have been accepted. Onsite registration on the
day of the meeting will be based on space availability. If you need
special accommodations because of a disability, please contact Meghana
Chalasani (see FOR FURTHER INFORMATION CONTACT) at least 7 days before
the meeting.
    Patients who are interested in presenting comments as part of the
initial panel discussions will be asked to indicate in their
registration which topic(s) they wish to address. These patients also
must send to<EMAIL_ADDRESS>a brief summary of responses to
the topic questions by May 27, 2016. Panelists will be notified of
their selection approximately 7 days before the public meeting. We will
try to accommodate all patients and patient stakeholders who wish to
speak, either through the panel discussion or audience participation;
however, the duration of comments may be limited by time constraints.
    Docket Comments: Regardless of whether you attend the public
meeting, you can submit electronic or written responses to the
questions pertaining to topics 1 and 2 to the public docket (see
ADDRESSES) by August 10, 2016. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov.
    Transcripts: As soon as a transcript is available, FDA will post it
at http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm470608.htm.

    Dated: April 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-08881 Filed 4-15-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 85 (Wednesday, May 2, 2018)]
[Notices]
[Page 19273]
[FR Doc No: 2018-09249]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #1

    Take notice that the Commission received the following electric
corporate filings:

    Docket Numbers: EC18-89-000.
    Applicants: CSOLAR IV South, LLC, CSOLAR IV WEST, LLC, CD Global
Solar II CSolar Holdings, LLC.
    Description: Joint Application for Approval Under Section 203 of
the Federal Power Act and Request for Expedited Approval of CSOLAR IV
South, LLC, et al.
    Filed Date: 4/26/18.
    Accession Number: 20180426-5174.
    Comments Due: 5 p.m. ET 5/17/18.

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER12-1266-009.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Clean-up filing regarding Order 745 to be effective 6/
12/2012.
    Filed Date: 4/26/18.
    Accession Number: 20180426-5073.
    Comments Due: 5 p.m. ET 5/17/18.

    Docket Numbers: ER18-926-001.
    Applicants: Southern California Edison Company.
    Description: Tariff Amendment: Amended GIA Stanton Energy
Reliability Center Project SA No. 999 to be effective 2/8/2018.
    Filed Date: 4/26/18.
    Accession Number: 20180426-5002.
    Comments Due: 5 p.m. ET 5/17/18.

    Docket Numbers: ER18-1294-001.
    Applicants: Woomera Energy, LLC.
    Description: Compliance filing: Woomera Market Based Rate Tariff to
be effective 12/31/9998.
    Filed Date: 4/26/18.
    Accession Number: 20180426-5120.
    Comments Due: 5 p.m. ET 5/17/18.

    Docket Numbers: ER18-1441-000.
    Applicants: Southern California Edison Company.
    Description: Sec.  205(d) Rate Filing: GIA and Distribution Service
Agmt SCEBESS-017 Project to be effective 4/26/2018.
    Filed Date: 4/25/18.
    Accession Number: 20180425-5204.
    Comments Due: 5 p.m. ET 5/16/18.

    Docket Numbers: ER18-1442-000.
    Applicants: Citizens Sycamore-Penasquitos Transmission LLC.
    Description: Baseline eTariff Filing: Initial Transmission Owner
Tariff Filing to be effective 12/31/9998.
    Filed Date: 4/25/18.
    Accession Number: 20180425-5211.
    Comments Due: 5 p.m. ET 5/16/18.

    Docket Numbers: ER18-1443-000.
    Applicants: Midcontinent Independent System Operator, Inc.,
Michigan Electric Transmission Company, LLC.
    Description: Sec.  205(d) Rate Filing: 2018-04-25_SA 1756 METC-
Consumers Energy 11th Rev GIA (G479B) to be effective 5/1/2018.
    Filed Date: 4/25/18.
    Accession Number: 20180425-5220.
    Comments Due: 5 p.m. ET 5/16/18.

    Docket Numbers: ER18-1444-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Sec.  205(d) Rate Filing: Amendment to WMPA SA No.
4648; Queue No. AB2-057 (Consent to Assign) to be effective 3/2/2017.
    Filed Date: 4/26/18.
    Accession Number: 20180426-5074.
    Comments Due: 5 p.m. ET 5/17/18.

    Docket Numbers: ER18-1445-000.
    Applicants: Idaho Power Company.
    Description: Compliance filing: LGIA, LGIP, SGIA, and SGIP
Modifications to be effective 6/25/2018.
    Filed Date: 4/26/18.
    Accession Number: 20180426-5102.
    Comments Due: 5 p.m. ET 5/17/18.

    Docket Numbers: ER18-1446-000.
    Applicants: Avista Corporation.
    Description: Tariff Cancellation: Avista Corp NITSA cancel to re-
file to be effective 4/27/2018.
    Filed Date: 4/26/18.
    Accession Number: 20180426-5149.
    Comments Due: 5 p.m. ET 5/17/18.

    Docket Numbers: ER18-1447-000.
    Applicants: Avista Corporation.
    Description: Sec.  205(d) Rate Filing: Avista Corp NITSA Re-filing
to be effective 4/27/2018.
    Filed Date: 4/26/18.
    Accession Number: 20180426-5160.
    Comments Due: 5 p.m. ET 5/17/18.

    Docket Numbers: ER18-1448-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Compliance filing: Notice of Cancellation of ISA,
Service Agreement No. 2381, NQ30 re: Deactivation to be effective N/A.
    Filed Date: 4/26/18.
    Accession Number: 20180426-5192.
    Comments Due: 5 p.m. ET 5/17/18.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: April 26, 2018.
Kimberly D. Bose,
Secretary.
[FR Doc. 2018-09249 Filed 5-1-18; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register: August 30, 2006 (Volume 71, Number 168)]
[Notices]
[Page 51595-51596]
[DOCID:fr30au06-77]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket Nos. EL06-99-000, QF05-147-001]

Pedricktown Cogeneration Company, LP; Notice of Filing

August 22, 2006.
    Take notice that on August 14, 2006, Pedricktown Cogeneration
Company, LP (Pedricktown) submitted a request for a waiver of the
efficiency standard for its qualifying cogeneration facility located in
Pedericktown, New Jersey, filed pursuant to section 292.205(c) of the
Commission's regulations in the above-captioned dockets.
    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, 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 on or before the comment date. On or before the comment date,
it is not necessary to 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<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on September 5, 2006.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-14383 Filed 8-29-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 87, Number 207 (Thursday, October 27, 2022)]
[Notices]
[Page 65109]
[FR Doc No: 2022-23352]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-96124; File Nos. SR-MIAX-2022-19, SR-EMERALD-2022-18]

Self-Regulatory Organizations; Miami International Securities
Exchange, LLC and MIAX Emerald, LLC; Notice of Withdrawal of Proposed
Rule Changes To Establish Fees for the Exchanges' cToM Market Data
Products

October 21, 2022.
    On April 29, 2022, Miami International Securities Exchange, LLC
(``MIAX'') and MIAX Emerald, LLC (``MIAX Emerald'') (collectively, the
``Exchanges'') each filed with the Securities and Exchange Commission
(``Commission''), pursuant to section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act''),\1\ and Rule 19b-4 thereunder,\2\ a
proposed rule change to establish fees for, respectively, the MIAX
Complex Top of Market (``cToM'') and the MIAX Emerald cToM market data
products.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

    The proposed rule changes were immediately effective upon filing
with the Commission pursuant to section 19(b)(3)(A) of the Act.\3\ The
proposed rule changes were published for comment in the Federal
Register and, pursuant to section 19(b)(3)(C) of the Act,\4\ the
Commission: (1) temporarily suspended the proposed rule changes; and
(2) instituted proceedings under section 19(b)(2)(B) of the Act \5\ to
determine whether to approve or disapprove the proposed rule
changes.\6\ On October 19, 2022, the Exchanges withdrew the proposed
rule changes (SR-MIAX-2022-19, SR-EMERALD-2022-18).
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78s(b)(3)(A). A proposed rule change may take
effect upon filing with the Commission if it is designated by the
exchange as ``establishing or changing a due, fee, or other charge
imposed by the self-regulatory organization on any person, whether
or not the person is a member of the self-regulatory organization.''
15 U.S.C. 78s(b)(3)(A)(ii).
    \4\ 15 U.S.C. 78s(b)(3)(C).
    \5\ 15 U.S.C. 78s(b)(2)(B).
    \6\ See Securities Exchange Act Release Nos. 94893 (May 11,
2022), 87 FR 29914 (May 17, 2022) (SR-MIAX-2022-19); and 94892 (May
11, 2022), 87 FR 29963 (May 17, 2022) (SR-EMERALD-2022-18).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
---------------------------------------------------------------------------

    \7\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

J. Matthew DeLesDernier,
Deputy Secretary.
[FR Doc. 2022-23352 Filed 10-26-22; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: February 25, 2010 (Volume 75, Number 37)]
[Notices]
[Page 8728]
[DOCID:fr25fe10-99]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[USCG-2010-0125]

Great Lakes Pilotage Advisory Committee

AGENCY: Coast Guard, DHS.

ACTION: Notice of meeting.

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

SUMMARY: The Great Lakes Pilotage Advisory Committee (GLPAC) will meet
at Coast Guard Marine Safety Unit Cleveland, Ohio. GLPAC provides
advice and makes recommendations to the Secretary on a wide range of
issues related to pilotage on the Great Lakes, including the rules and
regulations that govern the registration, operating requirements, and
training policies for all U.S. registered pilots. The Committee also
advises on matters related to ratemaking to determine the appropriate
charge for pilot services on the Great Lakes.

DATES: GLPAC will meet on Tuesday, March 16, 2010, and Wednesday, March
17, 2010 from 9 a.m. to 4 p.m. The meeting may close early if all
business is finished. Written material and requests to make oral
presentations or to have a copy of your material distributed to each
member of the committee should reach us on or before March 9, 2010.

ADDRESSES: GLPAC will meet at Coast Guard Marine Safety Unit Cleveland,
1055 E. 9th Street, Cleveland, OH 44114, in the main conference room.
Members of the public must produce valid photo identification for
access to the facility. Send written material and requests relating to
the GLPAC meeting to Mr. John Bobb (see FOR FURTHER INFORMATION
CONTACT). Electronically submitted material must be in Adobe or
Microsoft Word format. A copy of this notice is available in our online
docket, USCG-2010-0125, at http://www.regulations.gov; enter the docket
number for this notice (USCG-2010-0125) in the Search box, and click
``Go.''

FOR FURTHER INFORMATION CONTACT: Mr. John Bobb, GLPAC Assistant
Designated Federal Official (ADFO), Commandant (CG-54121), U.S. Coast
Guard Headquarters, 2100 Second Street, SW., Stop 7581, Washington, DC
20593-7581; telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, or e-mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The GLPAC is a Federal advisory committee
under 5 U.S.C. App. 2 (Pub. L. 92-463). It was established under the
authority of 46 U.S.C. 9307, and advises the Secretary of Homeland
Security and the Coast Guard on Great Lakes pilot registration,
operating requirements, training policies, and pilotage rates.
    GLPAC meets at least once a year but may also meet at other times
at the call of the Secretary. Further information about GLPAC is
available by searching on ``Great Lakes Pilotage Advisory Committee''
at http://www.fido.gov/facadatabase/.

Agenda of Meeting

    The agenda for the March 16-17, 2010 Committee meeting is as
follows:
    (1) Continue the GLPAC review of public comments solicited by the
Coast Guard in the Federal Register of July 21, 2009 (``Great Lakes
Pilotage Ratemaking Methodology,'' 74 FR 35838), in accordance with
requirements of 46 U.S.C. 9307(d) for Coast Guard consultation with
GLPAC before taking any significant action relating to Great Lakes
pilotage; and
    (2) Appointment of seventh member in compliance with requirements
of 46 U.S.C. 9307(b)(2)(E). Applications for this position were
solicited in a Federal Register notice published August 26, 2009 (74 FR
43148) and will be accepted until the position is filled.

Procedural

    The meeting is open to the public. Please note that the meeting may
close early if all business is finished. At the Chair's discretion,
members of the public may make oral presentations during the meeting.

Information on Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
Mr. John Bobb (see FOR FURTHER INFORMATION CONTACT) as soon as
possible.

    Dated: February 19, 2010.
W.A. Muilenburg,
Captain, U.S. Coast Guard, Office of Waterways Management.
[FR Doc. 2010-3836 Filed 2-24-10; 8:45 am]
BILLING CODE 9110-04-P


U.S. Environmental Protection Agency - October 2007

FY08 - FY10 Compliance and Enforcement National Priority

Clean Air Act, New Source Review/Prevention of Significant Deterioration

What is the Environmental Problem?

New Source Review (“NSR”) consists of two programs:  prevention of
significant deterioration (“PSD”) and nonattainment NSR.  New and
modified sources in attainment areas, i.e., where air quality standards
have been met, and in unclassifiable areas, are required to follow PSD
rules, which means they must obtain a pre-construction permit, prove
that the construction will not cause violations of certain air quality
standards, and show that that their operations are in continuous
compliance with the best available control technology (“BACT”)
requirements.  In nonattainment areas, i.e., where air quality standards
have not been met, new and modified sources are required to obtain
pre-construction permits, to offset emissions increases with emissions
reductions from other sources in the area, and to install lowest
achievable emissions rate technology (“LAER”).

To comply with the CAA, the NSR/PSD program requires that before new
sources begin construction, and existing sources change their processes,
they apply for and obtain pre-construction permits (where the new
construction or changes will cause emissions to increase above statutory
and regulatory emissions thresholds).  The United States Environmental
Protection Agency (“EPA”) has determined that many sources have made
changes to existing facilities without applying for and obtaining
pre-construction permits.  Consequently, sources have illegally
increased their emissions where they would have otherwise likely been
required to install pollution control technologies.

EPA has selected four industrial sectors for investigation based on the
probability of past modifications that would have required NSR/PSD
permits and the sectors’ overall emission profile.  The four sectors
are:  coal-fired electric utilities, cement manufacturing facilities,
sulfuric and nitric acid manufacturing facilities and glass
manufacturing facilities.

Why Are We Addressing The Problem?

The Agency selected the four sectors for the priority Strategy, because
each contributes significant amounts of pollutants to the atmosphere.
The coal-fired power plant sector emits approximately two-thirds of the
nation’s sulfur dioxide (“SO2”) and approximately one-third of the
nitrogen oxide (“NOx”).  The cement sector is the third largest
industrial source of pollution, emitting more than 500,000 tons per year
(“TPY”) of SO2, NOx and carbon monoxide (“CO”).  Acid plants
emit approximately 300,000 TPY of SO2 and NOx and glass plants emit
approximately 174,000 TPY of NOx, SO2 and particulate matter.
Investigation and enforcement of NSR/PSD in the latter three sectors has
the potential to reduce emissions up to 75% in each of these sectors,
with possible emission reductions of approximately 750,000 tons per
year.

A strong federal presence in NSR/PSD enforcement is necessary because of
widespread non-compliance with the NSR/PSD program in the identified
sectors and because of inconsistent permitting decisions made by
permitting authorities about both the necessity for permits and the
level of emission controls required.  Despite indications that many
cement, acid and glass facilities have made modifications requiring
preconstruction permits, only a small percentage of facilities have
NSR/PSD permits.  Where permits have been issued, many state permits do
not reflect the BACT for a particular industry.  Outside the permitting
context, a strong federal presence is necessary to ensure consistency in
approach to litigation and settlement.  Although EPA is playing a
significant role in NSR/PSD enforcement, the Agency is continuing to
actively encourage the states’ participation.

How is OECA Addressing the Problem?

OECA will utilize various tools to address violations in the priority
sector areas.  The primary tool to be utilized will be compliance
investigation and evaluation.  Compliance investigations can take
different forms but generally include some or all of the following: (1)
written information requests, (2) state/local permit file reviews, (3)
regional file reviews, (4) public information reviews, (5) on-site
compliance inspections, (6) source emission testing information
requests, (7) notices of violation, (8) administrative orders,
administrative penalty orders, or case referrals to the Department of
Justice, (9) supporting referred claims, (10) developing cases for
filing, and (11) training for regional personnel to increase the level
of awareness of NSR/PSD investigatory techniques.

Highlights from the FY 2005-2007 Planning Cycle

NSR/PSD was selected as a national enforcement and compliance priority
for the FY2005 - FY2007 priority cycle.  The priority had two
components.  First, the Office of Enforcement and Compliance Assurance
(“OECA”) continued its efforts to ensure coal-fired power plants
comply with the NSR/PSD program.  As a result of its efforts, EPA has
secured commitments that will reduce emissions of criteria pollutants by
more than one billion pounds per year at a cost of approximately $5.8
billion (for the installation of state-of-the-art air pollution
controls).  Second, OECA identified the cement, glass, and acid
manufacturing sectors for further NSR/PSD investigation.

 PAGE

 PAGE   2

Final: NSR/PSD Summary		October 2007


[Federal Register Volume 87, Number 185 (Monday, September 26, 2022)]
[Notices]
[Pages 58429-58430]
[FR Doc No: 2022-20751]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

[Docket No. FAA-2021--0601]

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Financial
Responsibility for Licensed Launch Activities

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The Federal Register Notice with a 60-day comment period
soliciting comments on the following collection of information was
published on January 13, 2022. The FAA collects information from
applicants for experimental permits in order to determine whether they
satisfy the requirements for obtaining an experimental permit.

DATES: Written comments should be submitted by October 26, 2022.

ADDRESSES: Written comments and recommendations for the proposed
information collection should be sent within 30 days of publication of
this notice to https://www.reginfo.gov/public/do/PRAMain. Find this
particular information collection by selecting ``Currently under 30-day
Review--Open for Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Charles Huet by email at:
[email protected]; phone:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information.
    OMB Control Number: 2120-0601.
    Title: Financial Responsibility for Licensed Launch Activities.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: The Federal Register Notice with a 60-day comment
period soliciting comments on the following collection of information
was published on January 13, 2022 (87 FR 2207). There were no comments.
In accordance with the Paperwork Reduction Act of 1995, FAA invites
public comments about our intention to request the Office of Management
and Budget (OMB) approval to renew an information collection. The
information to be collected will be used to determine if licensees have
complied with financial responsibility requirements for maximum
probable loss determination (MPL) analysis as set forth in FAA
regulations. The FAA is responsible for determining MPL required to
cover claims by a third party for bodily injury or property damage, and
the United States, its agencies, and its contractors and subcontractors
for covered property damage or loss, resulting from a Commercial space
transportation permitted or licensed activity. The MPL determination
forms the basis for financial responsibility requirements issued in a
license or permit order.
    Respondents: Approximately 10 applicants.
    Frequency: On Occasion.
    Estimated Average Burden per Response: $7,571.
    Estimated Total Annual Burden: 100 hours per year, totals $75,710.

    Issued in Washington, DC.
James Hatt,
Space Policy Division Manager, Office of Commercial Space
Transportation.
[FR Doc. 2022-20751 Filed 9-23-22; 8:45 am]
BILLING CODE 4910-13-P