[Federal Register Volume 85, Number 117 (Wednesday, June 17, 2020)]
[Notices]
[Pages 36600-36601]
[FR Doc No: 2020-13046]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1893]

Patient-Focused Drug Development: Collecting Comprehensive and
Representative Input; Guidance for Industry, Food and Drug
Administration Staff, and Other Stakeholders; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry, FDA staff, and other
stakeholders entitled ``Patient-Focused Drug Development: Collecting
Comprehensive and Representative Input.'' This guidance is the first of
a series of four methodological guidance documents that FDA committed
to develop to address in a stepwise manner how to collect and submit
information from patients and caregivers for medical product
development and regulatory decision making. This guidance finalizes the
draft guidance of the same title issued on June 13, 2018.

DATES: The announcement of the guidance is published in the Federal
Register on June 17, 2020.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2018-D-1893 for ``Patient-Focused Drug Development: Collecting
Comprehensive and Representative Input.'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday,<PHONE_NUMBER>.

     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 https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    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
Building, 4th Floor, Silver Spring, MD 20993-0002, or to the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, 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.

FOR FURTHER INFORMATION CONTACT: Meghana Chalasani, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6304, Silver Spring, MD 20993-0002, 240-
402-6525, Fax:<PHONE_NUMBER><EMAIL_ADDRESS>or Stephen
Ripley, Center for Biologics Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver
Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry, FDA
staff, and other stakeholders entitled ``Patient-Focused Drug
Development: Collecting Comprehensive and Representative Input.'' This
guidance (Guidance 1) is the first of a series of four guidance
documents that FDA committed to develop to address in a stepwise manner
how stakeholders (patients, researchers, medical product developers,
and others) can collect and submit information on the patient
experience for medical product development and regulatory decision
making. This series of guidance documents is intended to facilitate the
advancement and use of systematic approaches to collect and use robust
and meaningful patient and caregiver input that can more consistently
inform medical product development and regulatory decision making. The
purpose of Guidance 1 is to present methods for collecting information
on the patient experience that is representative of the intended
population to inform the development and evaluation of medical products
throughout the medical product lifecycle. In addition, this document
discusses methods on how to operationalize and standardize the
collection, analysis, and dissemination of patient experience data.
Guidance 1 also includes a glossary of terms that will be used in one
or more of the series of four guidance documents.
    From the outset, FDA recognized that developing this guidance would
benefit from public input from the wider community of patients, patient
advocates, academic researchers, expert practitioners, drug developers,
and other stakeholders. On December 18, 2017, FDA conducted a public
workshop to discuss this topic. FDA considered stakeholder input from
the workshop and associated public docket when drafting this guidance
(FDA-2017-N-5896).
    This guidance finalizes the draft guidance entitled ``Patient-
Focused Drug Development: Collecting Comprehensive and Representative
Input,'' issued on June 13, 2018 (83 FR 27618). FDA considered comments
received on the draft guidance as the guidance was finalized. Changes
from the draft to the final guidance include removing most of the
section and appendix on methods for collecting and analyzing patient
experience data since that information will be covered in later
guidances in the series. In addition, editorial changes were made to
improve clarity.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Patient-Focused Drug Development:
Collecting Comprehensive and Representative Input.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act

    This guidance refers to collections of information from
``individuals under treatment or clinical examination in connection
with research,'' which are not subject to review by the Office of
Management and Budget under 5 CFR 1320.3(h)(5). This guidance also
refers to previously approved FDA collections of information. These
collections of information are subject to review by the Office of
Management and Budget under the Paperwork Reduction Act of 1995 (44
U.S.C. 3501-3521). The collections of information in 21 CFR parts 50
and 56 have been approved under OMB control number 0910-0130.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
either https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: June 10, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-13046 Filed 6-16-20; 8:45 am]
BILLING CODE 4164-01-P


From:
David Ailor<EMAIL_ADDRESS>Sent:
Tuesday, August 2, 2022 2:53 PM
To:
French, Chuck<EMAIL_ADDRESS>Jones, DonnaLee<EMAIL_ADDRESS>Subject:
COETF Letter Detailing Concerns Regarding EPA's June 28, 2022 Coke Ovens Section 114 Information Collection Requests (ICRs)

Dear Mr. French and Dr. Jones:

On June 29, 2022, the four member companies of the Coke Oven Environmental Task Force (COETF) received Clean Air Act Section 114 Information Collection Requests (ICRs) from EPA.  The ICRs relate to the ongoing Pushing, Quenching, and Battery Stacks (PQBS) 40 CFR Part 63 Subpart CCCCC Risk and Technology Review (RTR) and the technology review for Coke Batteries under 40 CFR Part 63 Subpart L, but also include testing, interior and fenceline monitoring, and other information collection activities related to potential new regulations for coke byproduct recovery plants (CBRP).

The COETF engaged Trinity Consultants (Trinity) to assist us in assessing concerns with the ICRs.  Trinity has identified a number of safety, technical and schedule concerns insofar as the proposed ICR testing requirements and other information collection activities.  Attached to this e-mail is an August 2, 2022, letter from me to you setting forth the concerns of the COETF on the ICRs, reflecting the concerns identified to us by Trinity (see "August 2 2022 COETF Letter Detailing ICR Concerns.pdf"),.  In view of these concerns, the COETF requests that EPA make a number of changes to the ICRs.

In the coming days, I will contact you to schedule a date/time when we can meet to discuss these concerns with you.  In the meantime, please contact me if you have any questions.  David Ailor

David C. Ailor, P.E.
President
American Coke and Coal Chemicals Institute
25 Massachusetts Avenue, N.W.
Suite 800
Washington, D.C. 20001
Phone:<PHONE_NUMBER>
eFax.:<PHONE_NUMBER>
<EMAIL_ADDRESS>www.accci.org

<< August 2 2022 COETF Letter Detailing ICR Concerns.pdf >>


	Supporting Statement
	for
	Information Collection Request

	Reporting and Recordkeeping Requirements for

	Importation of On-highway Vehicles and Nonroad Engines, Vehicles, and Equipment

	EPA ICR Number 2583.03

	OMB Control Number: 2060-0717

	September 2022

	Compliance Division
	Office of Transportation and Air Quality
	Office of Air and Radiation
	U.S. Environmental Protection Agency

1.   IDENTIFICATION OF THE INFORMATION COLLECTION

(a)  TITLE OF THE INFORMATION COLLECTION

Reporting and Recordkeeping Requirements for Importation of On-highway Vehicles and Motorcycles and Nonroad Engines, Vehicles and Equipment, OMB 2060-0717 EPA ICR 2583.03.

(b)  SHORT CHARACTERIZATION (ABSTRACT)

The Clean Air Act requires that on-highway vehicles and motorcycles, and nonroad vehicles, engines and equipment imported into the U.S. either comply with applicable emission requirements or qualify for an applicable exemption or exclusion. The Compliance Division (CD) in the Office of Air and Radiation maintains and makes available instruments to importers to help facilitate importation of products at U.S. borders. EPA Form 3520-1 is used by importers of on-highway vehicles and motorcycles, and EPA Form 3520-21 is used by importers of nonroad vehicles, engines and equipment.

For EPA Declaration Form 3520-1 and 3520-21, U.S. Customs and Border Protection (CBP) regulations at 19 CFR 12.73 and 12.74 require importers to file the requisite information directly with CBP at the time of entry, with the exception of motor vehicles or stationary, nonroad or heavy-duty highway engines (including engines incorporated into vehicles or equipment). Engines that are imported by the Original Equipment Manufacturer (OEM) and hold an EPA certificate of conformity are labeled accordingly.

EPA makes both forms available on our website in fillable PDF format (http://www.epa.gov/importing-vehicles-and-engines/publications-and-forms-importing-vehicles-and-engines). EPA does not require that the forms be submitted directly to us, t Rather, these forms are used by CBP to facilitate the importation of products at U.S. borders. EPA requires that the forms be kept by importers for a period of five years after importation to assist EPA's Office of Enforcement and Compliance Assurance (OECA) and CBP in locating information should any issues arise with any given importation.

Since 2016, CBP has been using the Automated Commercial Environment (ACE) to facilitate the electronic filing of imports documents rather than collecting paper. ACE has become the primary system through which the trade community and other importers report imports and exports. Through ACE, manual processes have been streamlined and automated, and paper submissions (e.g. fillable PDFs) have been significantly reduced. The information detailed on both EPA forms has been incorporated into ACE. Rather than file hard copy forms, importers will log into ACE and check boxes that correspond to information elements currently found on the forms. Filers using the ACE interface will also receive transaction information that will be kept by the filer. However, EPA will continue to maintain the forms on our website in fillable PDF format. Although importers are expected to use the ACE interface to submit information, the PDF versions of the form can also be submitted directly into ACE by importers.

Information collected includes identification of the importer, the entry date, the manufacturer, the test group/engine family name, engine model and serial number, EPA exemption number if applicable, and bond information if applicable, and an indication of the regulatory category of vehicle, engine, or equipment of the relevant regulatory provision under which it is being imported. The information is submitted directly into ACE or can be submitted by filling in the applicable EPA declarations form and submitted to CBP at the time of importation. Importers must also make the information available to EPA upon request. The information is used to monitor compliance of imports with the law and regulations and to respond to inquiries from the public concerning the compliance status of specific imported engines.

EPA also makes available upon request EPA Form 3520-8 for use by independent commercial importers (ICIs) to request final admission (as opposed to initial declaration) of nonconforming vehicles. This only applies to light-duty vehicle importers who participate in the ICI program under 40 CFR Part 85, Subpart P. Because the ICI program is very small by nature, this form has not yet been incorporated into ACE as have forms 3520-1 and 3520-21 and will continue to be made available upon request as a fillable PDF form.

2.  NEED FOR AND USE OF THE COLLECTION

(a)  NEED/AUTHORITY FOR THE COLLECTION

Joint EPA and CBP regulations at 40 CFR 90.601 et seq. and 19 CFR 12.73 and 12.74 promulgated under the authority under the Clean Air Act (Sections 203, 208 and 213) give authority for the collection of information. The collection of this information helps ensure the compliance of imported vehicles, engines, and equipment with Federal emissions requirements, which helps meet the Agency goal of reducing air pollution. Without this information, EPA and CBP could not confirm that vehicles, engines and equipment being imported conform to the emission requirements of the Act or are appropriately eligible for an exemption from meeting the emissions requirements of the Act.

(b)  PRACTICAL UTILITY/USERS OF THE DATA

While EPA does not collect the forms directly from importers, we may ask for them upon request to assist CPB and/or EPA enforcement personnel for any given import for which there are questions or issues. The forms are primarily used by CBP at the time of importation to assist CBP in making determination if entry should be allowed. This information may also be used by CBP or EPA's enforcement personnel to verify that all vehicles, engines and equipment subject to Federal emission requirements have been declared upon entry or that the category of exclusion or exemption from emissions requirements has been identified in the declaration. The information is also used to identify and prosecute violators of the regulations. EPA staff with the appropriate clearances also have access to the ACE system and can view the data directly in the system.

3. NONDUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

(a)  NONDUPLICATION

Because the information collected is specific to identifying the appropriate regulated category and appropriate regulatory provisions for imported vehicles, engines and equipment under the Clean Air Act, the information is uniquely specific to EPA. With the paper forms, it was not practical to combine the information contained on the forms with other programs or agencies. However, with the ACE system, importers will now be able file the information electronically directly with CBP.

(b)  PUBLIC NOTICE REQUIRED PRIOR TO ICR SUBMISSION TO OMB

EPA will solicit public comment by means of a Federal Register Notice. The draft ICR was also placed in the docket.

(c)  CONSULTATIONS

The following representatives and manufacturers of imported vehicles, engines, and equipment provided feedback on the current process. EPA has also used data collected from the ACE system to help refine previous burden estimates.

Zachary Dendler
BMW
Emission Certification & Compliance (EG-8-US-21)
200 Chestnut Ridge Road Bldg. 150
Woodcliff Lake, NJ 07677

Jennifer Kamarek
Compliance Specialist
Vandegrift Customs Brokerage
500 E. Main Street
Norfolk, VA  23510

Shelly Tovatt
Harrison Wolf Consulting
17611 Metzler Lane
Huntington Beach, CA  92647

(d)  EFFECTS OF LESS FREQUENT COLLECTION

The forms are provided to CBP by the importer only when the products arrive at the port to assist CBP in facilitating entry of the products. Therefore, less frequent collection is not feasible. Note that one form or ACE entry per shipment may be used, provided attachments including all the information required to describe each vehicle or engine is included.

(e)  GENERAL GUIDELINES

Forms 3520-1 and 3520-21, are only filed with CBP once at the time of entry. For form 3520-8, this ICR requires that ICIs notify EPA when requesting final admission for vehicles and this may occasionally result in reporting more often than quarterly if vehicles are tested and ready for sale more frequently than quarterly. This requirement is necessary for EPA to have the opportunity to inspect vehicles prior to release from the ICI. If EPA only required quarterly reports, either the ICI would have to hold vehicles and release them on a quarterly basis or EPA would not likely have the opportunity to inspect or require confirmatory testing of vehicles imported by the ICI.

(f)  CONFIDENTIALITY

Any information submitted to the Agency for which a claim of confidentiality is made will be safeguarded according to policies set forth in Title 40, Chapter 1, Part 2, Subpart B - Confidentiality of Business Information (see 40 CFR 2.201 et seq.). The public is not permitted access to information containing personal or organizational identifiers.

(g) SENSITIVE QUESTIONS

 No sensitive questions are asked.

4. THE RESPONDENTS AND THE INFORMATION REQUESTED

(a)  RESPONDENTS/NAICS CODES

Information collected is from individual importers and both small and large companies who import or import and manufacture nonroad engines and recreational vehicles. The NAICS codes for the respondents are as follows:

Light-duty Vehicles
423110 	Automobile and Other Motor Vehicle Merchant Wholesalers
441200	Other Motor Vehicle Dealers.

Non-road compression ignition engines
333618	Manufacturers of nonroad diesel engines
333111	Manufacturers of farm machinery and equipment
333112	Manufacturers of lawn and garden tractors (home)
333924	Manufacturers of industrial trucks
333120	Manufacturers of construction machinery
333131	Manufacturers of mining machinery and equipment
333132	Manufacturers of oil and gas field machinery and equipment
811112, 811198	Commercial importers of vehicles and vehicle components
33631		Manufacturers of motor vehicle gasoline engine and engine parts
336312	Manufacturers of gasoline engine and engine parts
33639		Manufacturers of other motor vehicle parts

Small nonroad spark-ignition engines
333618	Other engine equipment manufacturing
336312	Gasoline engine and engine parts manufacturing
336999	Other transportation equipment manufacturing
336911	Motorcycle, bicycle and parts manufacturing

Marine outboard and personal watercraft engines
333618	Manufacturers of marine spark ignition engines
333112	Manufacturers of recreational marine vessels
336611	Ship building and repair
336612	Boat building
336999	Other marine outboard and personal watercraft manufacturing
441222	Motorcycle, boat, and other motor vehicle dealers

Locomotive engines
333618			Manufacturers of locomotives and locomotive engines
48211, 482111, 482112	Railroad owners and operators
488210			Engine repair and maintenance

Large marine compression-ignition engines

333618		Manufacturers of marine diesel engines
33661, 346611	Ship and boat building; ship building and repair
811310		Engine repair and maintenance
483			Water transportation, freight and passenger
336612	Boat building (watercraft not built in shipyards and typically of the type suitable or intended for personal use)
441222		Motorcycle, boat, and other motor vehicle dealers

Recreational vehicles, including snowmobiles, all-terrain vehicles, and certain high-speed utility vehicles
336991		Motorcycle manufacturers
336999		Snowmobile and all-terrain vehicle manufacturers
441222		Motorcycle, boat, and other motor vehicle dealers

Large nonroad spark-ignition engines
333618		Manufacturers of new nonroad spark-ignition engines
333111		Manufacturers of farm equipment
333112		Manufacturers of construction equipment
333924		Manufacturers of industrial trucks
811310		Engine repair and maintenance

(b)  INFORMATION REQUESTED

(i)  Data Items

The data requested include:

     	- vehicle or engine identification number
     	- vehicle or engine make
     	- vehicle or engine model
    	- model year of the vehicle or engine
     	- port of entry

    	- date of entry
     	- entry number
    	- importer name, address and telephone number
     	- broker name, address and telephone number (optional)
    	- owner name, address and telephone number (optional)
    	- identification of the type of vehicle or engine by regulatory category
     	- identification of the provision under which the vehicle or engine is being imported
    	-EPA exemption number, if applicable
	- Bond information, if applicable

(ii) Respondent Activities

     To complete the collection, the respondent would:

      	-read form instructions
      	-collect data and complete forms

Information Requirements for Importation of Motor Vehicles and Motor Vehicle Engines

INFORMATION REQUIREMENTS				CITATION

I. ICI requirements
- Reporting
- Application for final admission   				85.1505(a)
   (certified)
- Reasonable assistance during inspection, 			85.1506(c),(g)(4)
   including copies of records or documents 			85.1506(b)(2)
- Application for final admission   				85.1509(b)
   (modification/test)
- Repair and retest						85.1509(g)
- Maintenance instructions, attestation, 			85.1510(a)
   parts list
- Altitude compensator instructions, attestation 		85.1510(b)
- Emission warranties, attestation   				85.1510(c)
- Emission labeling, attestation   				85.1510(d)
- Fuel economy labeling, attestation 				85.1510(e)
- Gas guzzler tax forms, attestation 				85.1510(f)
- Reply to notice of suspension or  				85.1513(f)(3)(ii),
   revocation      						85.1513(f)(3)(iv)
   								85.1513(f)(6)
- Request for hearing    					85.1513(f)(3)(iii)

Recordkeeping
- Certification, modification, test, purchase, 			85.1507
   sale, storage, registration, importation
- Owners or ultimate purchasers 				85.1508(b)
- Maintenance instructions, parts list, 			85.1510
   altitude compensator instructions,
   emission warranties, emission labeling,
   fuel economy labeling

II. Requirements applying to all importers

- Notification of conditional admission 			85.1504(a)
- Request for prior approval (exemption), 			85.1511(b),(g)
   request for extension of exemption
- Request for prior approval (exclusion)			85.1511(c)-(g)
- Attestations, copy of paid invoice 				85.1512(f)
- Claim of confidentiality    					85.1514

Information Requirements for Importation of All Nonroad Vehicles, Engines, and Equipment

INFORMATION REQUIREMENTS			     	CITATION

I. Requirements applying to all importers

General provisions						1068.301
Applying for Exemptions or Exclusions 			1068.305
Available Exclusions						1068.310
Permanent Exemptions					1068.315
Temporary Exemptions 					1068.325
Penalties for Violations					1068.335
Restrictions to Assigning a Model Year			1068.360

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

(a)  AGENCY ACTIVITIES

The EPA Compliance Division does not collect the forms, but rather makes them available to importers and CBP to facilitate entry of goods at the port. The EPA's Compliance Division  and/or EPA's enforcement office may ask for them upon request to assist CBP and/EPA enforcement personnel for any given import for which there are questions or issues. The forms are primarily used by CBP at the time of importation to assist CBP in determining if entry should be allowed.

(b)  COLLECTION METHODOLOGY AND MANAGEMENT

CBP and EPA use the information to facilitate entry at the port to assess if vehicles, engines, and equipment meet EPA requirements, or are eligible for an applicable exemption. EPA does not collect the forms from importers. As described above, CBP is moving toward the electronic collection of the data elements contained on the forms that will streamline the reporting and recordkeeping burdens. With the implementation of ACE, importers will receive a transaction number which they will be required to maintain so that the importation records can be retrieved from the ACE database if needed.

(c)  SMALL ENTITY FLEXIBILITY

Small entities are required to submit the information covered by this ICR when applicable. There is no exemption for small entities.

(d) COLLECTION SCHEDULE

The information is not subject to a collection schedule, but is collected at the time of entry and, in the event of an ICI import, when the vehicle is ready for approval by EPA of final admission.

6. ESTIMATING THE BURDEN AND COST OF THE COLLECTION

6(a) ESTIMATING RESPONDENT BURDEN (Hours)

Each form is estimated to take 0.5 hours to complete. Completing required post-certification testing for ICIs is estimated to take 23 hours per test to complete. EPA estimates .25 hours for recordkeeping requirements for each ICI.

6(b) ESTIMATING RESPONDENT COST

(i) Labor Costs

Rates for engineering managers, mechanical engineers, and secretaries (except legal, medical, and executive) are from the May 2021 BLS National Occupational Employment and Wage Estimates (http://www.bls.gov/oes/current/oes_nat.htm, accessed August 30, 2022). With a 2.1 overhead multiplier, these are $153.82, $100, and $60.10, respectively.

(ii) Estimating Capital and Operations and Maintenance Costs

Capital/start-up costs are predominantly incurred by ICIs during the required certification process, which is covered by other ICRs. ICIs in the on-road program typically obtain the necessary testing and certification work from a broker, who also provides testing services, or who obtains from a testing facility the test results necessary for the final importation form.

(iii) Capital/Start-up vs. Operating and Maintenance Costs

The only Operating and Maintenance (O&M) costs associated with this ICR are incurred by ICIs during the required certification process, which is covered by other ICRs.

6(c) ESTIMATING AGENCY BURDEN AND COST

The imports program is administered by EPA's Compliance Division. Forty percent of one Full Time Equivalent employee (FTE), and a portion of the work assignment under a government contract are allocated to imports activities. Based on the 2022 Office of Personnel GS pay schedule for Detroit, EPA estimates a forty percent annual salary of $37, 260 for the EPA FTE. We then multiply the hourly rate by the standard government benefits multiplication factor of 1.6, for a cost of $59,616 for the EPA FTE, and $135,000 for the contractor. The previous ICR included an estimate for twenty percent of one Senior Environmental Employment (SEE) Program employee. As more entries are facilitated automatically by ACE, this has significantly reduced the amount of time needed by a SEE to assist with the program so that work has been incorporated into the contract mentioned above and has reduced the estimated agency burden by approximately $40,000.

6(d) ESTIMATING THE RESPONDENT UNIVERSE AND TOTAL BURDEN COSTS

Reporting, Recordkeeping, and Testing Burdens for Form 3520-8:			1,985 hrs
Reporting and Recordkeeping Burdens, Forms 3520-1 and 3520-21:		80,000 hrs
Total Hours										81,985 hrs

Recording, Recordkeeping, and Testing for Form 3520-8:				$ 196,549
Reporting and Recordkeeping Burdens, Forms 3520-1 and 3520-21:		$ 7,813,000
Total Cost										$ 8,009,549

6(e) BOTTOM LINE BURDEN HOURS AND COST TABLES

 Respondent Tally

The information collection estimates 14,810 respondents at an estimated labor cost of $8,009,549.

 The Agency Tally

The total EPA estimated burden is $194,616 and includes FTE and contractor dollars to support imports activities.

6(f) REASONS FOR CHANGE IN BURDEN

In looking at data provided by ACE from October 1, 2021  -  September 27, 2022, the number of entries (forms filed with CBP) has increased from approximately 160,000 per year to approximately 260,000 per year.  Therefore, the total estimated cost has increased by approximately $3,764,850 compared with the ICR currently approved by OMB.  This is due to the increased number of forms filed and also a slight increase in labor costs.

6(g) BURDEN STATEMENT

The annual public reporting and recordkeeping burden for this collection of information is estimated to average 45 minutes per response (30 minutes for reporting and 15 minutes for recordkeeping). Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a 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-OAR-2016-0094, which is available for online viewing at www.regulations.gov, or in person viewing at the Office of Air and Radiation docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Avenue, NW, Washington, D.C. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is<PHONE_NUMBER>, and the telephone number for the Office of Air and Radiation is<PHONE_NUMBER>. An electronic version of the public docket is available at 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.

 Also, you can send comments to the Office of Information and Regulatory Affairs, Office of Management and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk Officer for EPA. Please include the EPA Docket ID EPA-HQ-OAR-2016-0094 and OMB Control Number 2060-0717 in your correspondence.


[Federal Register: April 15, 2009 (Volume 74, Number 71)]
[Rules and Regulations]
[Page 17391-17392]
[DOCID:fr15ap09-10]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2008-1228; Airspace Docket No. 08-ACE-3]

Amendment of Class E Airspace; Omaha, NE

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: This action amends Class E airspace at Omaha, NE. Additional
controlled airspace is necessary to accommodate Area Navigation (RNAV)
Standard Instrument Approach Procedures (SIAP) at Blair Municipal
Airport, Blair, NE. This action also makes minor changes to the
geographic coordinates of the existing airports in the Omaha, NE,
airspace area. The FAA is taking this action to enhance the safety and
management of Instrument Flight Rule (IFR) operations at Blair
Municipal Airport.

DATES: Effective Date: 0901 UTC, July 2, 2009. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Scott Enander, Central Service Center,
Operations Support Group, Federal Aviation Administration, Southwest
Region, 2601 Meacham Blvd, Fort Worth, TX 76193-0530; telephone (817)
321-7716.

SUPPLEMENTARY INFORMATION:

History

    On January 13, 2009, the FAA published in the Federal Register a
notice of proposed rulemaking to amend Class E airspace at Omaha, NE,
adding additional controlled airspace at Blair Municipal Airport,
Blair, NE. (74 FR 1651, Docket No. FAA-2008-1228). Interested parties
were invited to participate in this rulemaking effort by submitting
written comments on the proposal to the FAA. No comments were received.
Class E airspace designations are published in paragraph 6005 of FAA
Order 7400.9S signed October 3, 2008, and effective October 31, 2008,
which is incorporated by reference in 14 CFR Part 71.1. The Class E
airspace designations listed in this document will be published
subsequently in that Order. With the exception of editorial changes,
and the changes described above, this rule is the same as that proposed
in the NPRM.

The Rule

    This action amends Title 14 Code of Federal Regulations (14 CFR)
Part 71 by amending Class E airspace at Omaha, NE, adding additional
controlled airspace at Blair Municipal Airport, Blair, NE. This action
also updates s the geographic coordinates for Eppley Airfield, Offutt
Air Force Base, and Council Bluffs Municipal Airport, to coincide with
the National Aeronautical Charting Office.
    The FAA has determined that this regulation only involves an
established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
Therefore, this regulation: (1) Is not a ``significant regulatory
action'' under Executive Order 12866; (2) is not a ``significant rule''
under DOT Regulatory Policies and Procedures (44 FR 11034; February 26,
1979); and (3) does not warrant preparation of a regulatory evaluation
as the anticipated impact is so minimal. Since this is a routine matter
that will only affect air traffic procedures and air navigation, it is
certified that this rule, when promulgated, will not have a significant
economic impact on a substantial number of small entities under the
criteria of the Regulatory Flexibility Act.
    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the U.S. Code. Subtitle 1, Section 106, describes
the authority of the FAA Administrator. Subtitle VII, Aviation
Programs, describes in more detail the scope of the agency's authority.
This rulemaking is promulgated under the authority described in
Subtitle VII, Part A,

Subpart I, Section 40103. Under that section, the FAA is charged with
prescribing regulations to assign the use of airspace necessary to
ensure the safety of aircraft and the efficient use of airspace. This
regulation is within the scope of that authority as it adds additional
controlled airspace at Blair Municipal Airport, Blair, NE.

List of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

0
In consideration of the foregoing, the Federal Aviation Administration
amends 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for 14 CFR part 71 continues to read as
follows:

    Authority:  49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854,
24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1  [Amended]

0
2. The incorporation by reference in 14 CFR part 71.1 of the Federal
Aviation Administration Order 7400.9S, Airspace Designations and
Reporting Points, signed October 3, 2008, and effective October 31,
2008, is amended as follows:

Paragraph 6005 Class E airspace areas extending upward from 700 feet
or more above the surface.
* * * * *

ACE NE E5 Omaha, NE [Amended]

Omaha, Eppley Airfield, NE
    (Lat. 41[deg]18'11'' N., long. 95[deg]53'39'' W.)
Omaha, Offutt AFB, NE
    (Lat. 41[deg]07'10'' N., long. 95[deg]54'31'' W.)
Council Bluffs, Council Bluffs Municipal Airport, IA
    (Lat. 41[deg]15'36'' N., long. 95[deg]45'31'' W.)
Blair, Blair Municipal Airport, NE
    (Lat. 41[deg]24'53'' N., long. 96[deg]06'32'' W.)

    That airspace extending upward from 700 feet above the surface
within a 6.9-mile radius of Eppley Airfield and within 3 miles each
side of the Eppley Airfield Runway 14R ILS Localizer course
extending from the 6.9-mile radius to 12 miles northwest of the
airport and within a 7-mile radius of Offutt AFB and within 4.3
miles each side of the Offutt AFB ILS Runway 30 localizer course
extending from the 7-mile radius to 7.4 miles southeast of Offutt
AFB and within a 6.4-mile radius of the Council Bluffs Municipal
Airport, and within a 6.4-mile radius of Blair Municipal Airport,
and within 2 miles each side of the 317[deg] bearing from the Blair
Municipal Airport extending from the 6.4-mile radius to 11.6 miles,
and within 2 miles each side of the 137[deg] bearing from the Blair
Municipal Airport extending from the 6.4-mile radius to 12.2 miles.
* * * * *

    Issued in Fort Worth, TX, on March 24, 2009.
Ronnie L. Uhlenhaker,
Acting Manager, Operations Support Group, Central Service Center.
 [FR Doc. E9-8577 Filed 4-14-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 58 (Friday, March 25, 2016)]
[Notices]
[Pages 16268-16269]
[FR Doc No: 2016-06730]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[Docket No. NHTSA-2016-0002; Notice 1]

Cooper Tire & Rubber Company, Receipt of Petition for Decision of
Inconsequential Noncompliance

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

ACTION: Receipt of petition.

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SUMMARY: Cooper Tire & Rubber Company (Cooper), has determined that
certain Cooper tires do not fully comply with paragraph S5.5.1(b) of
Federal Motor Vehicle Safety Standard (FMVSS) No. 139, New pneumatic
radial tires for light vehicles. Cooper filed a report dated January 8,
2016, pursuant to 49 CFR part 573, Defect and Noncompliance
Responsibility and Reports. Cooper then petitioned NHTSA under 49 CFR
part 556 requesting a decision that the subject noncompliance is
inconsequential to motor vehicle safety.

DATES: The closing date for comments on the petition is April 25, 2016.

ADDRESSES: Interested persons are invited to submit written data,
views, and arguments on this petition. Comments must refer to the
docket and notice number cited in the title of this notice and be
submitted by any of the following methods:
     Mail: Send comments by mail addressed to: 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 Deliver: Deliver comments by hand to U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590. The
Docket Section is open on weekdays from 10 a.m. to 5 p.m. except
Federal Holidays.
     Electronically: Submit comments electronically by logging
onto the Federal Docket Management System (FDMS) Web site at http://www.regulations.gov/. Follow the online instructions for submitting
comments. Comments may also be faxed to<PHONE_NUMBER>.
    Comments must be written in the English language, and be no greater
than 15 pages in length, although there is no limit to the length of
necessary attachments to the comments. If comments are submitted in
hard copy form, please ensure that two copies are provided. If you wish
to receive confirmation that comments you have submitted by mail were
received, please enclose a stamped, self-addressed postcard with the
comments. Note that all comments received will be posted without change
to http://www.regulations.gov, including any personal information
provided.
    The petition, supporting materials, and all comments received
before the close of business on the closing date indicated above will
be filed in the docket and will be considered. All comments and
supporting materials received after the closing date will also be filed
and will be considered to the extent possible.
    When the petition is granted or denied, notice of the decision will
also be published in the Federal Register pursuant to the authority
indicated at the end of this notice.
    All documents submitted to the docket may be viewed by anyone at
the address and times given above. The documents may also be viewed on
the Internet at http://www.regulations.gov by following the online
instructions for accessing the dockets. The docket ID number for this
petition is shown at the heading of this notice.
    DOT's complete Privacy Act Statement is available for review in the
Federal Register published on April 11, 2000, (65 FR 19477-78).

SUPPLEMENTARY INFORMATION:
    I. Overview: Pursuant to 49 U.S.C. 30118(d) and 30120(h) (see
implementing rule at 49 CFR part 556), Cooper submitted a petition for
an exemption from the notification and remedy requirements of 49 U.S.C.
Chapter 301 on the basis that this noncompliance is inconsequential to
motor vehicle safety.
    This notice of receipt of Cooper's petition is published under 49
U.S.C. 30118 and 30120 and does not represent any agency decision or
other exercise of judgment concerning the merits of the petition.
    II. Tires Involved: Affected are approximately 338 Cooper
Discoverer A/T3 size 265/70R18 Standard Load Tubeless Radial tires that
were manufactured between September 27, 2015 and October 3, 2015.
    III. Noncompliance: Cooper explains that the DOT serial week and
year appears upside down and backwards in the tire identification
number (TIN) molded into the outboard sidewalls of the subject tires
and those tires therefore do not meet the requirements specified in
paragraph S5.5.1 of FMVSS No. 139.
    IV. Rule Text: Paragraph S5.5.1 of FMVSS No. 139 requires in
pertinent part:

    S5.5.1 Tire Identification Number.
    . . .
    (b) Tires manufactured on or after September 1, 2009. Each tire
must be labeled with the tire identification number required by 49
CFR part 574 on the intended outboard sidewall of the tire. Except
for retreaded tires, either the tire identification number or a
partial tire identification number, containing all characters in the
tire identification number, except for the date code and, at the
discretion of the manufacturer, any optional code, must be labeled
on the other sidewall of the tire. Except for retreaded tires, if a
tire does not have an intended outboard sidewall, the tire must be
labeled with the tire identification number required by 49 CFR part
574 on one sidewall and with either the tire identification number
or a partial tire identification number, containing all characters
in the tire identification number except for the date code and, at
the discretion of the manufacturer, any optional code, on the other
side wall.

    V. Summary of Cooper's Petition: Cooper believes that this
noncompliance is inconsequential as it relates to motor vehicle safety.
    In support of its petition, Cooper submitted the following
information and analysis of the subject noncompliance:
    1. Cooper cited paragraph S5.5.1(b) of FMVSS No. 139, which
requires tires manufactured on or after September 1, 2009 to be labeled
with the TIN required by 49 CFR part 574 on the intended outboard
sidewall of the tire.
    2. Cooper also noted that 49 CFR 574.5 states that ``[e]ach tire
manufacturer shall conspicuously label on one sidewall of each tire it
manufactures . . . a tire identification number containing the
information set forth in paragraphs (a) through (d) of this section.''
The company further noted that 49 CFR 574.5(d) specifies that ``[t]he
fourth grouping, consisting of four numerical symbols, must identify
the week and year of manufacture,'' with the first two symbols
identifying the week and the last two identifying the year.
    3. Cooper stated that the subject tires, on the outboard side only,
were molded with an upside down and backwards DOT serial week and year.
The serial number stamping should read: ``DOT UPH4 1A6 3915.'' The
outboard side, which includes the date code, was molded with the date
code information oriented incorrectly upside down and backwards, which
resulted in the characters being out of proper sequence.
    4. Cooper explained that the existence of the stamping error was
determined by visual examination of a subject tire on October 21, 2015
by warehouse personnel in Grand Prairie, TX. Upon further
investigation, it was determined that only tires cured in one press

location (E10L) during one production week (3915) were affected. Tires
with the same SKU code were also curing in another press (Z11L), but
these tires were stamped correctly. Cooper stated that sorting of its
internal inventories revealed that for curing press E10L, during DOT
serial week 3915, there was a total net cure of 518 tires, of which 180
tires have been accounted for in its warehouse. There were 338 tires
distributed. Cooper made the final determination that a noncompliance
exists as to those 338 tires on January 6, 2015.
    5. Cooper states that the 338 subject tires do meet and/or exceed
all performance requirements and all other labeling and marking
requirements of FMVSS No. 139.
    Furthermore, Cooper is not aware of any crashes, injuries, customer
complaints, or field reports associated with the subject tires.
    Cooper has informed NHTSA that the subject tires located in its
inventory count reconciliation have been returned to the company's
Findlay, OH plant, where they will be corrected prior to being released
for sale.
    In summation, Cooper believes that the described noncompliance is
inconsequential to motor vehicle safety, and that its petition, to
exempt Cooper from providing recall notification of the noncompliance,
as required by 49 U.S.C. 30118, and remedying the noncompliance, as
required by 49 U.S.C. 30120, should be granted.
    NHTSA notes that the statutory provisions (49 U.S.C. 30118(d) and
30120(h)) that permit manufacturers to file petitions for a
determination of inconsequentiality allow NHTSA to exempt manufacturers
only from the duties found in sections 30118 and 30120, respectively,
to notify owners, purchasers, and dealers of a defect or noncompliance
and to remedy the defect or noncompliance. Therefore, any decision on
this petition only applies to the subject tires that Cooper no longer
controlled at the time it determined that the noncompliance existed.
However, any decision on this petition does not relieve equipment
distributors and dealers of the prohibitions on the sale, offer for
sale, or introduction or delivery for introduction into interstate
commerce of the noncompliant tires under their control after Cooper
notified them that the subject noncompliance existed.

    Authority: 49 U.S.C. 30118, 30120: delegations of authority at
49 CFR 1.95 and 501.8.

Jeffrey M. Giuseppe,
Director, Office of Vehicle Safety Compliance.
[FR Doc. 2016-06730 Filed 3-24-16; 8:45 am]
 BILLING CODE 4910-59-P