                      Information Collection Request for
             Diesel Emissions Reduction Act (DERA) Rebate Program

           OMB Control No. 2060-0686 (Renewal), EPA ICR No. 2461.03

                 United States Environmental Protection Agency
                          Office of Air and Radiation
                         1200 Pennsylvania Avenue, NW
                             Washington, DC 20460

Contents
1. Identification of the Information Collection	3
1(a) Title of the Information Collection	3
1(b) Short Characterization/Abstract	3
2. Need for and Use of the Collection	3
2(a) Need/Authority for the Collection	3
2(b) Practical Utility/Users of the Data	4
3. Non-duplication, Consultations, and Other Collection Criteria	5
3(a) Non-duplication	5
3(b) Public Notice Required Prior to ICR Submissions to OMB	5
3(c) Consultations	5
3(d) Effects of Less Frequent Collection	6
3(e) General Guidelines	7
3(f) Confidentiality	7
3(g) Sensitive Questions	7
4. The Respondents and the Information Requested	7
4(a) Respondents/Standard Industrial Classification (SIC) Codes	7
4(b) Information Requested	8
4(b)(i) Data Items	8
4(b)(ii) Respondent Activities	9
5(a) Agency Activities	10
5(b) Collection Methodology and Management	10
5(c) Small Entity Flexibility	11
5(d) Collection Schedule	11
6. Estimating the Burden and Cost of the Collection	12
6(a) Estimating Respondent Burden	12
6(b) Estimating Respondent Costs	12
6(b)(i) Estimating Labor Costs	12
6(b)(ii) Operating and Maintenance (O&M) Costs	12
6(b)(iii) Capital/Start-up Costs	12
6(c) Estimating Agency Burden and Cost	13
6(d) Estimating the Respondent Universe and Total Burden and Costs	13
6(e) Bottom Line Burden Hours and Cost Tables	13
6(e)(i) Respondent Tally	13
6(e)(ii) The Agency Tally	13
6(f) Reasons for Change in Burden	14
6(g) Burden Statement	14

Appendices
 Respondents and Agency Activities Table

Tables
Table 6.1 Respondent tally	13
Table 6.2 Agency tally	14

1. Identification of the Information Collection
1(a) Title of the Information Collection
Title: Diesel Emissions Reduction Act (DERA) Rebate Program
OMB Control Number: 2060-0686
EPA ICR Number: 2461.03
1(b) Short Characterization/Abstract
This is an extension of the Information Collection Request (ICR) for the Diesel Emission Reduction Act program (DERA) authorized by Title VII, Subtitle G (Sections 791 to 797) of the Energy Policy Act of 2005 (Public Law 109-58), as amended by the Diesel Emissions Reduction Act of 2010 (Public Law 111-364), codified at 42 U.S.C. 16131 et seq. DERA provides the Environmental Protection Agency (EPA) with the authority to award grants, rebates or low-cost revolving loans on a competitive basis to eligible entities to fund the costs of a retrofit technology that significantly reduces diesel emissions from mobile sources through implementation of a certified engine configuration, verified technology, or emerging technology. Eligible mobile sources include buses (including school buses), medium heavy-duty or heavy heavy-duty diesel trucks, marine engines, locomotives, or nonroad engines or diesel vehicles or equipment used in construction, handling of cargo (including at port or airport), agriculture, mining, or energy production. In addition, eligible entities may also use funds awarded for programs or projects to reduce long-duration idling using verified technology involving a vehicle or equipment described above. The objective of the assistance under this program is to achieve significant reductions in diesel emissions in terms of tons of pollution produced and reductions in diesel emissions exposure, particularly from fleets operating in areas designated by the Administrator as poor air quality areas.

EPA uses approved procedures and forms to collect necessary information to operate a grant program, and has been providing grants under DERA since Fiscal Year 2008 and rebates since Fiscal Year 2012. EPA is requesting an extension to the existing approved ICR for forms needed to collect necessary information to operate a rebate program as authorized by Congress under the DERA program.

EPA will collect information from applicants who wish to apply for a rebate under the DERA Rebate Program. Information collected from applicants will ensure that they are eligible to receive funds under DERA, that funds are provided for eligible activities, and to calculate estimated and actual emissions benefits that result from activities funded with rebates as required in DERA's authorizing legislation.
2. Need for and Use of the Collection
2(a) Need/Authority for the Collection
This ICR is necessary to ensure that only eligible entities will receive funds under this program, and that funds are only provided for eligible activities per the DERA legislation (42 U.S.C. 16131 et seq.).  The information requested on the Rebate Application and the Payment Request form is also needed to ensure the activities are completed in accordance with program guidance.  In addition, the information is necessary to ensure fiscal control and accountability for EPA funds and to deter waste, fraud, and abuse.

Congress requires EPA to calculate and report on the estimated and actual air quality and diesel fuel conservation benefits resulting from DERA funding, as well as cost-effectiveness and cost-benefits of the grant, rebate and loan programs. To accurately provide this required information to Congress, EPA must collect specific information about the vehicles and technologies funded through the DERA program.
2(b) Practical Utility/Users of the Data
The rebate process requires applicants to submit up to two forms. All applicants fill out an application to reserve funds (Rebate Application) that asks for information about the applicant including DUNS number, EIN, contact information for representatives, address, and number of vehicles to be retrofitted or replaced. This information is required to ensure the applicant is eligible, and to have contact information on file. All applicants will also provide information on the current vehicle to be replaced or retrofitted. Information requested includes the fleet type, vehicle identification number, engine model year, gross vehicle weight rating, engine manufacturer, engine family name, engine tier, and average annual vehicle miles traveled or usage rate, annual fuel consumption, annual idling hours, and horsepower (for nonroad engines only). This information is collected to ensure the vehicle or equipment being replaced or retrofitted is eligible under the DERA rebate program guidelines.  In addition, the information will be used to calculate the estimated emissions reductions that will be achieved by the rebate funding, and to meet the statutory requirements to report to Congress the estimated air quality and diesel fuel conservation benefits, cost-effectiveness, and cost-benefits of that activity prior to the activity occurring.

EPA will make random selections from the pool of eligible applicants but may give priority consideration to those applicants for projects located in areas of poor air quality. EPA may also ensure that each region or state is represented in the group of selectees. Upon notification from EPA, the selectee may purchase the vehicle or equipment specified in the rebate program guidance. After purchase and installation of the new vehicle or equipment, the selectee will request payment from EPA by submitting the Payment Request Form. The selectee will also submit a copy of all invoices for the purchase and installation of the new vehicle or equipment as well as written confirmation and photographs documenting that the replaced equipment was scrapped. This information is necessary to meet the statutory requirements to report to Congress the actual air quality and diesel fuel conservation benefits and cost-effectiveness of the funded rebate project. In addition, the information collected will ensure fiscal control and accountability for EPA funds and to deter waste, fraud, and abuse.

3. Non-duplication, Consultations, and Other Collection Criteria
3(a) Non-duplication
Information requested from respondents under this ICR is not available from other sources. There are no existing rebate programs at EPA where this information may have been previously collected. Some rebate applicants may have applied for and received grants from EPA; however, information currently held in EPA's Integrated Grants Management System that could pertain to the rebate program would likely only consist of applicant names, addresses, and other identifying information that would not be burdensome for a rebate applicant to reproduce. Other information related to the specific vehicle(s) targeted for rebates would not be readily available from other sources.
3(b) Public Notice Required Prior to ICR Submissions to OMB
In compliance with the 1995 Paperwork Reduction Act (PRA), any agency developing a non-rule-related ICR must solicit public comments for a 60-day period before submitting the ICR to OMB. These comments, which are used partly to determine realistic burden estimates for respondents, must be considered when completing the Supporting Statement that is submitted to OMB.
3(c) Consultations
EPA staff responsible for DERA program oversight and implementation were contacted to provide information, data, and review for this ICR renewal.

During the initial setup of the Rebate Program, EPA solicited information on rebate program structure, management, and information collection from other federal, state and local rebate programs, including:

 USDOT CARS Program ("Cash for Clunkers")
      Contact: Terry Anderson, National Highway Traffic Safety Administration
<PHONE_NUMBER>

 California Air Resources Board (CARB) Hybrid Truck and Bus Voucher Incentive Project
      Contact: Joe Calavita, CARB
<PHONE_NUMBER>

 Pittsburgh Healthy School Bus Initiative
      Contact: Brooke Suter, Clean Air Task Force
<PHONE_NUMBER>

Additionally, EPA consulted with representatives from industries potentially affected by a rebate program to determine availability of the information we are requesting on the rebate forms and the typical process and time required to procure a new vehicle or retrofit an existing vehicle.

For this renewal, EPA contacted five applicants that have received rebates from previous rebate funding opportunities and requested feedback about how long the rebate process took to complete. EPA requested that applicants provide estimates of how much time was required to review instructions, gather information about existing vehicles, fill out necessary forms, and to complete submission to EPA. The burden hours from responses are recorded in Table A8 in Appendix A. The first two applicants listed below, Fremont USD and Aransas County ISD, responded to this request, while the remaining three applicants did not:

 Fremont Unified School District
      Contact: Charles Ott
<PHONE_NUMBER> x 13106
<EMAIL_ADDRESS>
 Aransas County Independent School District
      Contact: Kathy Henderson
<PHONE_NUMBER> x 8008
<EMAIL_ADDRESS>
 Pymatuning Valley Local School
      Contact: Tom Brockway
<PHONE_NUMBER>
<EMAIL_ADDRESS>
 Lind-Ritzville Transportation Co-Op
      Contact: Lynn Sackmann
<PHONE_NUMBER>
<EMAIL_ADDRESS>
 Huntington Coach Corporation
      Contact: Brendan Clifford
<PHONE_NUMBER>
<EMAIL_ADDRESS>3(d) Effects of Less Frequent Collection
EPA recognizes the importance of balancing the need for data collection efforts against respondent burden and costs. The information needed for EPA to assess whether a rebate applicant is eligible to receive a rebate is expected to be submitted one time for each rebate funding opportunity. Individual applicants may apply for multiple rebates at one time (the maximum number will be announced by EPA at the start of a new rebate funding opportunity). The Rebate Application and the Payment Request Form can accommodate information related to several vehicles and/or retrofit technologies. EPA needs current information about the vehicle(s) to be replaced or retrofitted and the proposed replacement vehicle(s) or retrofit technology(s) to properly evaluate rebate eligibility and to calculate the emissions reductions that will be achieved through the rebate. The burden described in this ICR identifies the burden that EPA has determined as necessary. EPA strives to minimize burden. EPA has determined that the information currently required is the minimum that is necessary to adequately evaluate applicant eligibility and to calculate the emissions reductions that will be achieved through the rebate.
3(e) General Guidelines
This information collection is consistent with OMB guidelines contained in 5 CFR 1320.5(d)(2). Requests for supplemental information for the purposes of emergency response or enforcement activities are exempt from the Paperwork Reduction Act requirements.
3(f) Confidentiality
Applicants will not be required to submit confidential business information. If an applicant feels that any information requested would be confidential business information, the applicant may request that such information be treated as confidential. All confidential data will be handled in accordance with 40 CFR 122.7, 40 CFR Part 2, and EPA's Security Manual Part III, Chapter 9, dated August 9, 1976. Any claim of confidentiality must be asserted at the time of submission.
3(g) Sensitive Questions
Sensitive questions are defined in EPA's ICR Handbook, Guide to Writing Information Collection Requests Under the Paperwork Reduction Act of 1995 as "questions concerning sexual behavior or attitudes, religious beliefs, or other matters usually considered private."  The requirements addressed in this ICR do not include sensitive questions.
4. The Respondents and the Information Requested
4(a) Respondents/Standard Industrial Classification (SIC) Codes

The primary recipients of EPA rebates are State and local governments, Indian Tribes, educational institutions, and certain private organizations.  The information requested is used to determine rebate eligibility, pay recipients, and collect information on how Federal funds are being spent.

Standard Industrial Classification Codes for respondents include:

1629		 -  Heavy Construction, Not Elsewhere Classified
4011 		 -  Railroads, Line-Haul Operating
4013		 -  Railroad Switching and Terminal Establishments
4111		 -  Local and Suburban Transit
4212		 -  Local Trucking Without Storage
4213		 -  Trucking, Except Local
4151		 -  School Buses
4449		 -  Water Transportation of Freight, Not Elsewhere Classified
4489		 -  Water Transportation of Passengers, Not Elsewhere Classified
4491		 -  Marine Cargo Handling
4492		 -  Towing and Tugboat Services
8211 		 -  Elementary and Secondary Schools
8221 		 -  Colleges, Universities, and Professional Schools
8399		 -  Social Services, Not Elsewhere Classified
9199		 -  General Government, Not Elsewhere Classified

The corresponding North American Industry Classification System (NAICS) Codes for respondents include:

23		 -  Construction
482 		 -  Rail Transportation
483 		 -  Water Transportation
484		 -  Truck Transportation
485		 -  Transit and Ground Passenger Transportation
4854		 -  School and Employee Bus Transportation
48831		 -  Port and Harbor Operations
61111 		 -  Elementary and Secondary Schools
61131 		 -  Colleges, Universities, and Professional Schools
9211 		 -  Executive, Legislative, and Other Government Support
9221		 -  Justice, Public Order, and Safety Activities

4(b) Information Requested
This section presents the data items, including recordkeeping requirements, and required respondent activities involved in preparing and submitting those data items.
4(b)(i) Data Items

For this ICR renewal EPA is making minor changes to the data items collected in the Rebate Application and will have a negligible effect on the time required for applicant responses.

On the Rebate Application, these changes include:
 Adding Street Address, City, and Zip Code fields so that private fleets serving public entities can identify the location of those public entities more precisely.
 Adding Name, Title, Email, and Phone number fields so that applicants can list a second point of contact.

The following data items are expected to be collected as part of a rebate application and payment request process:

 Applicant name, address, and other identifying information, such as Employer Identification Number, Dun and Bradstreet Number, and whether the applicant identifies as a federally recognized tribe
 Primary and alternate applicant contact information, such as name, title, phone number, and email address
 If a private applicant, name and address of the eligible entity for which the applicant operates under a contract, license, or lease, per requirements in the DERA authorization language
 Fleet size  -  total number of vehicles or equipment in regular operation
 If the applicant's vehicles operate under an idle reduction policy
 Information on the original vehicle(s) for which the rebate(s) is requested, including:
 Vehicle identification number (VIN)
 Engine manufacturer, model year, tier level and family name
 Gross vehicle weight rating
 Average annual miles driven (or usage rate for non-road equipment)
 Annual fuel consumption
 Annual hours idling
 Horsepower (for non-road equipment)
 Emissions control strategy (retrofit/replacement)
 Information on the replacement vehicle(s) or retrofit technology(ies), to ensure that DERA program objectives will be met, including:
 For vehicle/equipment replacement rebates:
 VIN
 New engine manufacturer, model year, tier level and family name
 Gross vehicle weight rating
 New vehicle fuel type
 New vehicle cost
 For retrofit rebates:
 Retrofit technology type, manufacturer, and model
 Retrofit technology cost
 Installation cost
 For engine repower rebates:
 New engine manufacturer, model year, tier level and family name
 Engine serial number
 Horsepower (for nonroad engines)
 New engine fuel type
 Repower cost (engine and installation)
4(b)(ii) Respondent Activities

DERA Rebate Program applicants must perform the following:

 Submit a completed Rebate Application signed by an Authorized Representative, within the open application period
 Subject to random selection from the pool of eligible applicants to participate, selectee will submit proof of purchase (such as a copy of a Purchase Order or other equivalent documentation) showing that a new vehicle or retrofit technology has been ordered, within a designated period of times specified in the program guidance
 Selectee will submit a Payment Request Form signed by an Authorized Representative along with evidence of completion of the rebate-eligible activity (e.g., for vehicle replacements, written verification and photographs demonstrating scrappage of the old vehicle along with an invoice and proof of delivery of the new vehicle) to obtain a rebate payment, within a designated period of time specified in the program guidance
 Retain all records related to the rebate application and payment for a period of 3 years

5. The Information Collected -- Agency Activities, Collection Methodology, and Information Management
5(a) Agency Activities
This ICR includes all the application and reimbursement forms related to EPA's Diesel Emissions Reduction Act Rebate Program. EPA will continue to accept, evaluate, and identify selectees from the pool of eligible applicants for eligible rebate activities. EPA will subsequently review each selectee's payment request form and associated invoices to determine if payment is warranted. EPA will enter information on all eligible applicants, selectees, vehicles, and rebate payments into a database to manage the rebate program.

Agency activities associated with the review and approval of a rebate consist of the following:

 Review and determine eligibility of application submissions
 Identify selectees randomly from the eligible pool of applicants
 Notify selectees and non-selectees within 90 days of the closing date for the application submission period
 Create a wait-list of eligible applicants that were not selected in the initial random selection
 Reserve (obligate) funds for selectees
 Review of proof of purchase submitted by selectees
 Determine and notify the selectee, within 30 days of rebate request submission, whether submission is complete and rebate can be issued
 Issue rebate payment to selectees
5(b) Collection Methodology and Management
EPA will continue to collect data from applicants and selectees, such as identification information, vehicle specifications, and payment information. EPA will store the information in a database to manage the rebate program. Data supplied by rebate applicants and selectees on paper or electronic forms (via email) will be entered into the database by EPA or a contractor to EPA. EPA will ensure the accuracy and completeness of collected information by reviewing applications and information entered in the database. EPA will use data collected on processed rebate requests to estimate the emission reductions and cost-effectiveness of the rebate program for its required biennial report to Congress.
5(c) Small Entity Flexibility
For many reasons, EPA believes the reporting requirements discussed in this ICR do not place an unreasonable burden on small businesses. The Rebate Application and the Payment Request Form collect minimal information needed to identify an applicant or selectee, verify eligibility, and evaluate the proposed action for rebate eligibility. The Rebate Application is submitted once for all eligible vehicles and equipment.  If that applicant is selected to participate in the rebate program via random selection, a Payment Request Form is submitted after all program requirements have been met, to receive payment. The burden represented by the Rebate Application and the Payment Request Form cannot be further reduced for small businesses.  EPA needs certain basic information to make decisions regarding rebate payments.  This basic information is not dependent on an operator's size.

Minimizing the burden on small entities also comes in the form of guidance materials.  For example, to assist applicants of all sizes, but potentially most useful for small entities, EPA will develop guidance on applying for a rebate.
5(d) Collection Schedule
Applying for a rebate is a voluntary activity. Information collection will begin once EPA announces the availability of a funding opportunity and makes the program guidance available on the internet (www.epa.gov/cleandiesel).  Applicants may apply for rebate funds during a designated open time window (e.g. within 30 days of the program announcement) by submitting a Rebate Application.  At the end of the open time window, EPA will make random selections from the pool of eligible applicants.  EPA may also ensure that each region is represented in the group of selectees.  All eligible applicants not selected will be placed on a waitlist, in the event that additional funds become available.  Selectees will then have a designated period of time, as specified in the program guidance, to submit evidence to EPA that an order has been placed for a new vehicle or retrofit (proof of purchase), such as a copy of a purchase order.  Finally, selectees will have a designated period of time from proof of purchase submittal, as specified in the program guidance, to submit a Payment Request Form with required supporting documentation to obtain a rebate.  The designated period of time for selectees to submit the proof of purchase and submit the Payment Request Form with supporting documentation will be dependent on the specific rebate funding opportunity, based on the target fleet and emissions control strategy applied.
6. Estimating the Burden and Cost of the Collection
6(a) Estimating Respondent Burden
 This section presents the estimated respondent burden for each information request.  Data are tabulated in the "Respondents and Agency Activities Table" provided as Appendix A.  That table presents all assumptions, calculations, and results discussed in this ICR. The breakdown of cost and burden by labor category is provided in Section 6(b).
6(b) Estimating Respondent Costs
With burden hour estimates in place from Section 6(a), the next step is to estimate the labor cost per respondent and the capital costs required to complete each activity.  The total cost for each respondent activity is composed of the following:
Labor Cost;
Operating and Maintenance (O&M) Cost; and
Capital/Start-up Cost.

The results of the respondents' costs analysis are presented in the Respondents and Agency Activities Table in Appendix A. Note that there are no O&M or capital costs associated with the DERA Rebate Program.
6(b)(i) Estimating Labor Costs
To estimate the potential costs, EPA identified labor categories associated with performing each activity.  Labor categories include managerial, technical, and clerical.  Mean hourly wage data was obtained from the Bureau of Labor Statistics (BLS) news release, Employer Costs for Employee Compensation (March 2018).  This dataset can be found at http://www.bls.gov/news.release/ecec.t02.htm and https://www.bls.gov/news.release/ecec.t09.htm.  Table A1 in Appendix A shows the wage rates used to determine the cost of labor for various types of applicants.

The previously approved ICR renewal used wage rates from the Bureau of Labor Statistics (BLS) news release, Employer Costs for Employee Compensation (March 2015).
6(b)(ii) Operating and Maintenance (O&M) Costs
This ICR accounts for labor costs only. The DERA rebate program does not require respondents to perform activities outside the normal operation practices.
6(b)(iii) Capital/Start-up Costs
This ICR accounts for labor costs only. The DERA rebate program does not require respondents to perform activities outside the normal operation practices.
6(c) Estimating Agency Burden and Cost
EPA's estimate of its burden and costs are from the activities described in Section 5(a).  When calculating the Agency cost, EPA makes the following assumption:

EPA determined the hourly employment cost of federal employees using methodology established in previous ICRs.  According to the U.S. Office of Personnel Management, 2018 General Schedule (2018-GS), the average annual salary of a government employee at the GS-13, Step 10 level is $98,317.  Step 10 is assumed to account for overhead costs.  At 2,086 hours per year, the hourly wage, including overhead, is $47.13

Burden and costs incurred by EPA are presented in Table A7 in Appendix A.
6(d) Estimating the Respondent Universe and Total Burden and Costs
Detailed information describing the universe and basis for burden and costs is provided in Section 6(a).  Results are presented in Tables A2 through A6 in Appendix A.  Those tables provide the respondent universe and the source of information for all respondent categories used throughout this ICR.
6(e) Bottom Line Burden Hours and Cost Tables
6(e)(i) Respondent Tally
The bottom line burden hours and costs for rebate applicants are the average annual hours and costs collectively incurred for all activities during the 6-year period covered by this ICR.  Table 6.1 provides a summary of the average annual number of applicants, burden hours, and costs. A more detailed summary is provided in Tables A2 through A6 in Appendix A.

                          Table 6.1 Respondent tally
Respondents (number)
                                                                            629
Responses (number)
                                                                            707
Burden (hours)
                                                                           2945
Costs (labor)
                                                                    $103,197.33
Costs (capital)
                                                                             $0
Costs (O&M)
                                                                             $0
Total costs
                                                                    $103,197.33
Average annual burden per respondent
                                                                        $164.07
6(e)(ii) The Agency Tally
The bottom line burden hours and costs for the Agency are the total annual hours and costs collectively incurred for all activities during the period covered by this ICR. Table 6.2 provides a summary of the average annual Agency burden hours and costs. A more detailed summary is provided in Table A7 in Appendix A.

                            Table 6.2 Agency tally
Responses (number)
                                                                            707
Burden (hours)
                                                                            746
Costs (labor)
                                                                     $35,158.98
Costs (capital)
                                                                             $0
Costs (O&M)
                                                                             $0
Total costs
                                                                     $35,158.98

6(f) Reasons for Change in Burden
There is an increase of 118 hours in the annual estimated respondent burden compared with the approved ICR.  The revised burden of 2,945 hours reflects a 4.2% increase in burden compared to the previous 2015 estimate of 2,827 hours.  This increase is due to a higher reported burden by the two responses to consultation outreach.  The higher burden reported by these past respondents was weighted against previous estimates for the latest burden estimate.
6(g) Burden Statement
The annual public reporting and recordkeeping burden for this collection of information is estimated to average 4.2 hours per response.  Burden means the total time, effort, or financial resources expended by persons to generate, maintain, or disclose or provide information to or for a federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose 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 EPA'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, the Agency has established a public docket for this ICR under Docket ID No. EPA-HQ-OAR-2012-0103, which is available for public viewing at the Air and Radiation Docket in the EPA Docket Center (EPA/DC), 1200 Pennsylvania 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 Air Docket is<PHONE_NUMBER>.  An electronic version of the public docket is available through www.regulations.gov. Use www.regulations.gov to submit or view public comments, to access the index listing of the contents of the public docket, and to access documents in the public docket that are available electronically. Once in the system, 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 Office for EPA.  Please include the EPA Docket ID No. EPA-HQ-OAR-2012-0103 and OMB Control No. 2060-0686 in any correspondence.


[Federal Register Volume 80, Number 175 (Thursday, September 10, 2015)]
[Notices]
[Pages 54656-54657]
[FR Doc No: 2015-22791]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket Number FRA-2015-0083]

Notice of Application for Approval of Discontinuance or
Modification of a Railroad Signal System

    In accordance with part 235 of Title 49 Code of Federal Regulations
(CFR) and 49 U.S.C. 20502(a), this document provides the public notice
that by a document dated July 7, 2015, Norfolk Southern Corporation
(NS) petitioned the Federal Railroad Administration (FRA) seeking
approval for the discontinuance or modification of a signal system. FRA
assigned the petition Docket Number FRA-2015-0083.
    Applicant: Norfolk Southern Corporation, Mr. B. L. Sykes, Chief
Engineer, C&S Engineering, 1200 Peachtree Street NE., Atlanta, GA
30309.
    NS seeks approval of the discontinuance of Control Point (CP) Raitt
on the Buchanan Branch, Milepost (MP) D-16.3, at Weller, VA. All
existing signals will be removed and the existing power-operated switch
will be converted to a hand-operated switch. Current operating rules in
the area will not change.
    The reason given for the proposed discontinuance is that it is no
longer needed for current railroad operations.
    A copy of the petition, as well as any written communications
concerning the petition, is available for review online at
www.regulations.gov and in person at the U.S. Department of
Transportation's (DOT) Docket Operations Facility, 1200 New Jersey
Avenue SE., W12-140, Washington, DC 20590. The Docket Operations
Facility is open from 9 a.m. to 5 p.m., Monday through Friday, except
Federal Holidays.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before

the end of the comment period and specify the basis for their request.
    All communications concerning these proceedings should identify the
appropriate docket number and may be submitted by any of the following
methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal Holidays.

Communications received by October 26, 2015 will be considered by FRA
before final action is taken. Comments received after that date will be
considered as far as practicable.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the comment (or signing the document,
if submitted on behalf of an association, business, labor union, etc.).
In accordance with 5 U.S.C. 553(c), DOT solicits comments from the
public to better inform its processes. DOT posts these comments,
without edit, including any personal information the commenter
provides, to www.regulations.gov, as described in the system of records
notice (DOT/ALL-14 FDMS), which can be reviewed at www.dot.gov/privacy.
See also http://www.regulations.gov/#!privacyNotice for the privacy
notice of regulations.gov.

    Issued in Washington, DC, on September 1, 2015.
Ron Hynes,
Director, Office of Technical Oversight.
[FR Doc. 2015-22791 Filed 9-9-15; 8:45 am]
 BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 117 (Monday, June 18, 2012)]
[Proposed Rules]
[Pages 36211-36213]
[FR Doc No: 2012-14798]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2012-0636; Directorate Identifier 2012-NM-037-AD]
RIN 2120-AA64

Airworthiness Directives; Airbus Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain Airbus Model A300 B4-601, B4-603, and B4-605R airplanes, Model
A300 F4-605R airplanes, Model A300 C4-605R Variant F airplanes, and
Model A310-204 and -304 airplanes, powered by General Electric (GE)
CF6-80C2 series engines. This proposed AD was prompted by reports of
two single-engine flame-out events during inclement weather. This
proposed AD would require installing a shunt of the rotary selector
(introducing an auto-relight function). We are proposing this AD to
prevent a long engine restart sequence after a non-selection of
continuous re-light by the crew and a flame-out event of both engines,
which could result in reduced controllability of the airplane,
especially at low altitude.

DATES: We must receive comments on this proposed AD by August 2, 2012.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
    For service information identified in this proposed AD, contact
Airbus SAS--EAW (Airworthiness Office), 1 Rond Point Maurice Bellonte,
31707 Blagnac Cedex, France; telephone +33 5 61 93 36 96; fax +33 5 61
93 44 51; email<EMAIL_ADDRESS>Internet http://www.airbus.com.
    You may review copies of the referenced service information at the

FAA, Transport Airplane Directorate, 1601 Lind Avenue SW., Renton,
Washington. For information on the availability of this material at the
FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov; or in person at the Docket Operations office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Operations office (telephone<PHONE_NUMBER>) is
in the ADDRESSES section. Comments will be available in the AD docket
shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-2125; fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2012-0636;
Directorate Identifier 2012-NM-037-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD based on those comments.
    We will post all comments we receive, without change, to http://www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Community, has issued EASA
Airworthiness Directive 2011-0113, dated June 17, 2011 (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    Two single [engine] flame out events attributed to inclement
weather occurred on Wide Body (WB) aeroplanes powered with GE CF6-
80C2 engines.
    On WB aeroplanes, no auto-relight function is embodied. To avoid
long engine restart sequence after a non selection of continuous
relight by the crew and a flame out event of both engines, resulting
in strongly reduced control of the aeroplane especially at low
altitude, the manufacturer Airbus designed a modification by
introducing auto-relight function for aeroplanes powered by GE CF6-
80C2 engines.
    For the reason described above, this EASA AD requires the
installation on the aeroplane of an auto-relight function
[installing a shunt of the rotary selector] as a precaution and to
increase restart capability without crew action.

You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Airbus has issued Mandatory Service Bulletin A310-74-2003, Revision
02, including Appendix 1, dated February 9, 2012 (for Model A310-204
and -304 airplanes); and Mandatory Service Bulletin A300-74-6003,
Revision 02, including Appendix 1, dated February 9, 2012 (for Model
A300 B4-601, B4-603, and B4-605R airplanes, Model A300 F4-605R
airplanes, and Model A300 C4-605R Variant F airplanes). The actions
described in this service information are intended to correct the
unsafe condition identified in the MCAI.

FAA's Determination and Requirements of This Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with the State of Design Authority, we have
been notified of the unsafe condition described in the MCAI and service
information referenced above. We are proposing this AD because we
evaluated all pertinent information and determined an unsafe condition
exists and is likely to exist or develop on other products of the same
type design.

Costs of Compliance

    Based on the service information, we estimate that this proposed AD
would affect about 47 products of U.S. registry. We also estimate that
it would take about 80 work-hours per product to comply with the basic
requirements of this proposed AD. The average labor rate is $85 per
work-hour. Required parts would cost about $12,500 per product. Where
the service information lists required parts costs that are covered
under warranty, we have assumed that there will be no charge for these
parts. As we do not control warranty coverage for affected parties,
some parties may incur costs higher than estimated here. Based on these
figures, we estimate the cost of the proposed AD on U.S. operators to
be $907,100, or $19,300 per product.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979);
    3. Will not affect intrastate aviation in Alaska; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Airbus: Docket No. FAA-2012-0636; Directorate Identifier 2012-NM-
037-AD.

(a) Comments Due Date

    We must receive comments by August 2, 2012.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to Airbus Model A300 B4-601, B4-603, and B4-605R
airplanes Model A300 F4-605R airplanes, Model A300 C4-605R Variant F
airplanes, and Model A310-204 and -304 airplanes; certificated in
any category; all serial numbers, powered by General Electric (GE)
CF6-80C2 series engines.

(d) Subject

    Air Transport Association (ATA) of America Code 74: Ignition.

(e) Reason

    This AD was prompted by reports of two single-engine flame-out
events during inclement weather. We are issuing this AD to prevent a
long engine restart sequence after a non-selection of continuous re-
light by the crew and a flame-out event of both engines, which could
result in reduced controllability of the airplane, especially at low
altitude.

(f) Compliance

    You are responsible for having the actions required by this AD
performed within the compliance times specified, unless the actions
have already been done.

(g) Modification

    Within 6,000 flight hours or 30 months after the effective date
of this AD, whichever occurs later: Modify the airplane by
installing a shunt of the rotary selector (introducing an auto-
relight function), in accordance with the Accomplishment
Instructions of Airbus Mandatory Service Bulletin A300-74-6003,
Revision 02, including Appendix 1, dated February 9, 2012 (for Model
A300 B4-601, B4-603, and B4-605R airplanes, Model A300 F4-605R
airplanes, and Model A300 C4-605R Variant F airplanes); or Airbus
Mandatory Service Bulletin A310-74-2003, Revision 02, including
Appendix 1, dated February 9, 2012 (for Model A310-204 and -304
airplanes).

(h) Credit for Previous Actions

    This paragraph provides credit for the actions required by
paragraph (g) of this AD, if those actions were performed before the
effective date of this AD using the applicable service information
specified in paragraphs (h)(1) or (h)(2) of this AD.
    (1) Airbus Mandatory Service Bulletin A300-74-6003, Revision 01,
including Appendix 1, dated April 1, 2011 (for Model A300 B4-601,
B4-603, and B4-605R airplanes, Model A300 F4-605R, and Model A300
C4-605R Variant F airplanes).
    (2) Airbus Mandatory Service Bulletin A310-74-2003, Revision 01,
including Appendix 1, dated April 1, 2011 (for Model A310-204 and -
304 airplanes).

(i) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
International Branch, ANM-116, FAA, has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19. In accordance with 14 CFR 39.19, send your request to your
principal inspector or local Flight Standards District Office, as
appropriate. If sending information directly to the International
Branch send it to ATTN: Dan Rodina, Aerospace Engineer,
International Branch, ANM-116, Transport Airplane Directorate, FAA,
1601 Lind Avenue SW., Renton, Washington 98057-3356; telephone (425)
227-2125; fax<PHONE_NUMBER>. Information may be emailed to<EMAIL_ADDRESS>Before using any approved AMOC, notify
your appropriate principal inspector, or lacking a principal
inspector, the manager of the local flight standards district
office/certificate holding district office. The AMOC approval letter
must specifically reference this AD.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.

(j) Related Information

    Refer to MCAI EASA Airworthiness Directive 2011-0113, dated June
17, 2011; and the service information specified in paragraph (j)(1)
and (j)(2) of this AD; for related information.
    (1) Airbus Mandatory Service Bulletin A300-74-6003, Revision 02,
including Appendix 1, dated February 9, 2012.
    (2) Airbus Mandatory Service Bulletin A310-74-2003, Revision 02,
including Appendix 1, dated February 9, 2012.

    Issued in Renton, Washington, on June 7, 2012.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2012-14798 Filed 6-15-12; 8:45 am]
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[Federal Register: June 11, 2010 (Volume 75, Number 112)]
[Notices]
[Page 33311-33312]
[DOCID:fr11jn10-77]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0433] (formerly Docket No. 2007D-0169)

Guidance for Industry on Bioequivalence Recommendations for
Specific Products; Availability

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``Bioequivalence
Recommendations for Specific Products.'' This guidance describes a new
process for making available recommendations on how to design product-
specific bioequivalence (BE) studies to support abbreviated new drug
applications (ANDAs). Under this process, applicants planning to carry
out such studies in support of their ANDAs are able to access BE study
guidance on the FDA Web site. FDA believes that making this information
available on the Internet will streamline the guidance process and will
provide a meaningful opportunity for the public to consider and comment
on product-specific BE study recommendations.

DATES:  Submit either electronic or written comments on agency
guidances at any time.

ADDRESSES:  Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 2201, Silver Spring, MD 20993-0002. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance to http://
www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Doan T. Nguyen, Center for Drug
Evaluation and Research (HFD-600), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Bioequivalence Recommendations for Specific Products.'' This
guidance describes a new process for making available recommendations
on how to design product-specific BE studies to support ANDAs. Under
this process, draft and final BE recommendations are posted on FDA's
Web site (http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm,
Individual Product Bioequivalence Recommendations) and announced
periodically in the Federal Register. For draft BE recommendations, the
Federal Register notice will identify a comment period. The public is
encouraged to submit comments on the draft BE recommendations, and the
agency will consider received comments in developing final BE
recommendations. FDA adopted this process as a means to develop and
disseminate product-specific BE recommendations and provide an
opportunity for the public to consider and comment on those
recommendations.
    In the Federal Register of May 31, 2007 (72 FR 30388), FDA
announced the availability of a draft version of this guidance entitled
``Bioequivalence Recommendations for Specific

Products.'' The May 2007 draft guidance gave interested persons an
opportunity to submit comments through August 29, 2007. The agency is
finalizing the guidance after considering comments received on the
draft guidance. Minor changes were made to the draft guidance to update
FDA Web site information.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
agency's current thinking on a new process for making available to
sponsors FDA guidance on how to design product-specific bioequivalence
studies to support ANDAs. It does not create or confer any rights for
or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding the
guidance. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/
GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http:/
/www.regulations.gov.

    Dated: June 3, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-14036 Filed 6-10-10; 8:45 am]
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[Federal Register Volume 79, Number 200 (Thursday, October 16, 2014)]
[Notices]
[Pages 62163-62164]
[FR Doc No: 2014-24597]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-1675]

New Chemical Entity Exclusivity Determinations for Certain Fixed-
Combination Drug Products; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a guidance for industry entitled ``New Chemical Entity
Exclusivity Determinations for Certain Fixed-Combination Drug
Products.'' This guidance sets forth a change in the Agency's
interpretation of the 5-year new chemical entity (NCE) exclusivity
statutory and regulatory provisions as they apply to certain fixed-
combination drug products (fixed combinations). As described in the
guidance, a drug product will be eligible for 5-year NCE exclusivity if
it contains a drug substance that meets the definition of ``new
chemical entity,'' regardless of whether that drug substance is
approved in a single-ingredient drug product or in certain fixed-
combinations. This guidance finalizes the draft guidance issued in
February 2014.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Nisha Shah, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Jay
Sitlani, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6272, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``New Chemical Entity Exclusivity Determinations for Certain
Fixed-Combination Drug Products.'' This guidance sets forth a change in
the Agency's interpretation of the 5-year NCE exclusivity provisions as
they apply to certain fixed-combinations. Section 505(c)(3)(E)(ii) and
(j)(5)(F)(ii) of the Food, Drug, and Cosmetic Act and 21 CFR 314.108,
among other provisions, establish the scheme under which a drug product
is eligible for 5-year NCE exclusivity. The Agency historically
interpreted the term ``drug'' as it appears in the first sub-clause of
the statutory provisions and in the definition of ``new chemical
entity'' in its regulation to mean ``drug product.'' This resulted in a
fixed-combination not being eligible for 5-year NCE exclusivity if it
contained any drug substance that contained an active moiety that had
been previously approved by the Agency, even if the fixed-combination
also contained another drug substance that contained a previously
unapproved active moiety.
    The Agency recognizes, however, that fixed-combinations have become
increasingly prevalent in certain therapeutic areas and that these
products play an important role in optimizing adherence to dosing
regimens and improving patient outcomes. Therefore, to further
incentivize the development of fixed-combinations containing previously
unapproved active moieties, the guidance sets forth the Agency's
revised interpretation regarding the eligibility for 5-year NCE
exclusivity of certain fixed-combinations. Under the revised
interpretation, the term ``drug'' in the relevant provisions is
interpreted to mean ``drug substance'' or ``active ingredient,'' and
not ``drug product.'' Accordingly, a drug product is eligible for 5-
year NCE exclusivity provided that it contains a drug substance that
contains no active moiety that has been previously approved. This will
permit a drug substance that meets the definition of new chemical
entity (i.e., one that contains no previously approved active moiety)
to be eligible for 5-year NCE exclusivity, regardless of whether it is
approved in a single-ingredient drug product, in a fixed-combination
with another drug substance that contains no other previously approved
active moiety, or in a fixed-combination with another drug substance
that contains a previously approved active moiety.
    In the Federal Register of February 24, 2014 (79 FR 10167), this
guidance was published as a draft guidance. We have carefully reviewed
and considered the comments that were received on the draft guidance.
We have made editorial changes primarily for clarification.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on 5-year NCE exclusivity for certain fixed-
combinations. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Comments

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

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The collection of information in 21 CFR parts 314 have been
approved under OMB control number 0910-0001.

IV. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: October 9, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-24597 Filed 10-15-14; 8:45 am]
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