MEMORANDUM

DATE:  August 30, 2011

FROM: Colleen McKaughan

TO: File

SUBJECT:  Consultation Meeting with Moapa Tribe on Reid Gardner Power
Plant

The Moapa Band of Paiutes and EPA Region 9 had a consultation meeting on
August 11, 2011 at the Moapa Reservation outside of Las Vegas, Nevada.
The Regional Administrator for Region 9, Jared Blumenfeld, and Colleen
McKaughan, Associate Director, Air Division, along with other Region 9
staff and managers (via conference line) met with Chairman William
Anderson, Moapa Band of Paiutes, several members of the Tribal Council,
and the attorney representing Moapa, Dan Galpern of the Western
Environmental Law Center.

At the time of the consultation, EPA had proposed approval of the Nevada
Regional Haze SIP, including the BART determination for the Reid Garner
Generating Station (RGGS). The focus of the consultation was the
Tribe’s position that the NOx controls and associated emission limits
for RGGS were not strong enough to protect the Tribe.  They believe the
Tribe is suffering ill health as a result of emissions from this plant
and that this is an environmental justice issue.

EPA received a subsequent letter from the Tribe dated August 18, 2011,
reiterating their position then formal comments on EPA’s proposed
approval of the Nevada Regional Haze SIP dated August 22, 2011.


[Federal Register Volume 76, Number 121 (Thursday, June 23, 2011)]
[Notices]
[Pages 36927-36928]
[FR Doc No: 2011-15689]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0315]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Fusilev, Levoleucovorin

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for Fusilev (Levoleucovorin) and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of an application to the
Director of Patents and Trademarks, Department of Commerce, for the
extension of a patent which claims that human drug product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and 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: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, rm. 6222, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human drug product will include all of the testing phase
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product Fusilev
(levoleucovorin calcium), a folate analog. Levoleucovorin rescue is
indicated after high-dose methotrexate therapy in osteosarcoma and is
also indicated to diminish the toxicity and counteract the effects of
impaired methotrexate elimination and/or inadvertent overdosage of
folic acid antagonists. Subsequent to this approval, the Patent and
Trademark Office received a patent term restoration application for
Fusilev (U.S. Patent No. 6,500,829) from the University of Strathclyde,
and the Patent and Trademark Office requested FDA's assistance in
determining this patent's eligibility for patent term restoration and
that FDA determine the product's regulatory review period. In a letter
dated June 1, 2011, FDA advised the Patent and Trademark Office that
this human drug product had undergone a regulatory review period and
that the approval of Fusilev represented the first permitted commercial
marketing or use of the product.
    FDA has determined that the applicable regulatory review period for
Fusilev is 6,993 days. Of this time, 703 days occurred during the
testing phase of the regulatory review period, while 6,290 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 355(i)) became
effective: January 15, 1989. The applicant claims December 15, 1988, as
the date the investigational new drug application (IND) became
effective. However, FDA records indicate that the IND effective date
was January 15, 1989, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: December
18, 1990. The applicant claims December 14, 1990, as the date the new
drug application (NDA) for FUSILEV (NDA 20-140) was initially
submitted. However, FDA records indicate that NDA 20-140 was submitted
on December 18, 1990.
    3. The date the application was approved: March 7, 2008. FDA has
verified the applicant's claim that NDA 20-140 was approved on March 7,
2008.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 797 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by August 22, 2011. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by December 20, 2011. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see

ADDRESSES) electronic or written comments and written petitions. It is
only necessary to send one set of comments. It is no longer necessary
to send three copies of mailed comments. However, if you submit a
written petition, you must submit three copies of the petition.
Identify comments with the docket number found in brackets in the
heading of this document.
    Comments and petitions that have not been made publicly available
on http://www.regulations.gov may be viewed in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 2, 2011.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2011-15689 Filed 6-22-11; 8:45 am]
BILLING CODE 4160-01-P


												November 8, 2007

HUMAN HEALTH RISK ASSESSMENT (HHRA) SUBCOMMITTEE

DRAFT AGENDA

November 14-16, 2007

Residence Inn Bethesda-Downtown

Bethesda, MD

Wednesday, November 14, 2007

8:00 -8:30 a.m. 	Registration

8:30 - 8:45 a.m.	Welcoming Remarks/				Dr. George Daston,

Subcommittee Introduction			Subcommittee Chair

8:45 - 9:00 a.m.	DFO Remarks/Meeting Logistics		Ms. Joanna Foellmer,

Subcommittee DFO, Office of Research and Development (ORD)

9:00 - 9:15 a.m.	Human Health Risk Assessment: 		Dr. Peter Preuss, ORD

Accomplishing EPA’s Mission	Director, National Center for Environmental Assessment (NCEA)

9:15 - 9:45 a.m.	Overview of LTG3:  Integrated Science 	Dr. Ila Cote, ORD/NCEA

			Assessments

- Air Quality Criteria Documents

9:45 - 11:15 a.m.	Poster Session: LTG3

11:15 – 12:00 p.m.	Poster Session Discussion/Questions 		HHRA Subcommittee

on LTG3

12:00 - 1:00 p.m.	Lunch

1:00 - 1:30 p.m.	Overview of LTG1: IRIS and 		Dr. Abdel Kadry,

Other Priority Health Assessments 	 	ORD/NCEA

1:30 - 2:45 p.m.	Poster Session: LTG1

2:45- 3:15 p.m.	Poster Session Discussion/			HHRA Subcommittee

			Questions on LTG1

3:15 - 3:30 p.m.	Break

3:30 - 4:30 p.m.	Program Office Perspectives			Ms Betsy Southerland,

OSWER/OSRTI and

Ms. Lydia Wegman,

OAR/OAQPS

4:30 - 5:00 p.m.	Wrap –Up 					Dr. George Daston,

									Subcommittee Chair

5:00 p.m.		Adjourn

Thursday, November 15, 2007

10:00 - 10:15 a.m.	Review of Agenda and Day 1			Dr. George Daston,

									Subcommittee Chair

10:15 - 10:45 a.m.	Overview of LTG2:  Methods, 		Mr. David Bussard,

Models and Guidance				ORD/NCEA

10:45 - 12:15 p.m.	Poster Session: LTG2

12:15 - 12:30 p.m.	Public Comment

12:30 - 1:30 p.m.	Lunch

1:30 - 2:00 p.m.	Poster Session Discussion/			HHRA Subcommittee

Questions on LTG2

2:00 - 2:40 p.m.	Regional Prospective 				Mr. Kerrigan Clough,										 	DRA, Region 8 and 												Ms. Kathy Callahan,

									DRA, Region 2

2:40 – 3:00 p.m.	Partnerships/Collaborations			Dr. Tom Burke,

Bloomberg School of Public Health, Johns Hopkins University

3:00 - 3:30 p.m.	IRIS User Analysis:				Mr. Jim Solyst,

Background and Preliminary Results	Environ, Arlington, VA

3:30 – 5:00 p.m.	Subcommittee Working Time			HHRA Subcommittee

5:00 p.m.		Adjourn

Friday, November 16, 2007

8:30 -11:30 a.m.	Subcommittee Working Time				HHRA Subcommittee

11:30 - 12:00 p.m. 	Preliminary Report Out				Dr. George Daston,

										Subcommittee Chair

12:00 p.m.		Adjourn

Human Health Risk Assessment Subcommittee November 2007 Draft Meeting Agenda

-  PAGE  2 -

            A Federal Advisory Committee for the U.S. Environmental Protection Agency’s Office of Research and Development


MEMORANDUM

DATE:		November 10, 2014

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Howard J. Hoffman, EPA - OGC

SUBJECT:	November 10, 2014 Phone Call with Advanced Energy Economy Regarding Proposed Clean Power Plan for Existing Power Plants  --------------------------------------------------------------------------------

SUMMARY On November 10, 2014, I spoke by telephone with Malcolm Woolf and Matt Stanberry of Advanced Energy Economy to discuss legal issues concerning the proposed Clean Power Plan for existing power plants.


[Federal Register Volume 77, Number 151 (Monday, August 6, 2012)]
[Notices]
[Pages 46793-46795]
[FR Doc No: 2012-19123]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2012-0214]

Qualification of Drivers; Exemption Applications; Vision

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Notice of applications for exemptions; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 12 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. They are unable to meet the vision requirement in
one eye for various reasons. The exemptions will enable these
individuals to operate commercial motor vehicles (CMVs) in interstate
commerce without meeting the prescribed vision requirement in one eye.
If granted, the exemptions would enable these individuals to qualify as
drivers of commercial motor vehicles (CMVs) in interstate commerce.

DATES: Comments must be received on or before September 5, 2012.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2012-0214 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the
    on-line instructions for submitting comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building Ground Floor,
Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: 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.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

FOR FURTHER INFORMATION CONTACT: Elaine M. Papp, Chief, Medical
Programs Division,<PHONE_NUMBER><EMAIL_ADDRESS>FMCSA,
Department of Transportation, 1200 New Jersey Avenue SE., Room W64-224,
Washington, DC 20590-0001. Office hours are from 8:30 a.m. to 5 p.m.,
Monday through Friday, except Federal holidays.

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to or greater than the level that would be achieved
absent such exemption.'' FMCSA can renew exemptions at the end of each
2-year period. The 12 individuals listed in this notice have each
requested such an exemption from the vision requirement in 49 CFR
391.41(b)(10), which applies to drivers of CMVs in interstate commerce.
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.

Qualifications of Applicants

Michael J. Bechta

    Mr. Bechta, age 28, had had amblyopia in his left eye since
childhood. The best corrected visual acuity in his right eye is 20/20,
and in his left eye, 20/80. Following an examination in 2012, his
ophthalmologist noted, ``With these parameters, in my opinion, Michael
is safe and qualified visually to drive commercial vehicles.'' Mr.
Bechta reported that he has driven straight trucks for 7 years,
accumulating 36,400 miles. He holds a Class C operator's license from
Pennsylvania. His driving record for the last 3 years shows one crash,
which he was not cited for, and no convictions for moving violations in
a CMV.

Bryan G. Brockus

    Mr. Brockus, 42, had an enucleation of his left eye due to a
traumatic injury sustained as a child. The visual acuity in his right
eye is 20/20. Following an examination in 2012, his ophthalmologist
noted, ``In my opinion, this patient has sufficient vision to perform
the driving tasks to operate a commercial vehicle.'' Mr. Brockus
reported that he has driven straight trucks for 14 years, accumulating
252,000 miles, and tractor-trailer combinations for 3 years,
accumulating 15,000 miles. He holds a Class A Commercial Driver's
License (CDL) from Idaho. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

Larry Clay

    Mr. Clay, 55, has had amblyopia in his left eye since childhood.
The best corrected visual acuity in his right eye is 20/20, and in his
left eye, 20/400. Following an examination in 2012, his optometrist
noted, ``I do believe Mr Clay has sufficient vision to perform his job
in operating a commercial vehicle.'' Mr. Clay reported that he has
driven straight trucks for 10 years, accumulating 52,000 miles. He
holds a Class D operator's license from New Mexico. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Michael T. DeKorte

    Mr. DeKorte, 42, has had amblyopia and Peter's Anomaly in his left
eye since childhood. The best corrected visual acuity in his right eye
is 20/15, and in his left eye, 20/400. Following an examination in
2012, his ophthalmologist noted, ``no restriction or visual impairment
that should limit ability to operate a commercial vehicle.'' Mr.
DeKorte reported that he has driven straight trucks for 23 years,
accumulating 460,000 miles, and tractor-trailer combinations for 23
years, accumulating 460,000 miles. He holds a Class A CDL from
Michigan. His driving record for the last 3 years shows no crashes and
one conviction for speeding in a CMV; he exceeded the speed limit by 5
mph.

Erric L. Gomersall

    Mr. Gomersall, 45, has had macular scarring and histoplasmosis in
his right eye since 2005. The best corrected visual acuity in his right
eye is 20/50, and in his left eye, 20/20. Following an examination in
2012, his ophthalmologist noted, ``In my medical opinion Erric
Gomersall does have the visual ability to perform the driving tasks
required to operate a commercial vehicle.'' Mr. Gomersall reported that
he has driven tractor-trailer combinations for 6 years, accumulating
780,000 miles. He holds a Class A CDL from Wisconsin. His driving
record for the last 3 years shows one crash, which he was not cited
for, and no convictions for moving violations in a CMV.

Larry E. Johnsonbaugh, Jr.

    Mr. Johnsonbaugh, 42, has a prosthetic left eye due to a traumatic
injury sustained in 1992. The visual acuity in his right eye is 20/20.
Following an examination in 2012, his ophthalmologist noted, ``Mr.
Johnsonbaugh is well adapted to his monocular status and, therefore,
with a normal right eye with a full visual field he should not have any
limitations in operating a commercial vehicle.'' Mr. Johnsonbaugh
reported that he has driven straight trucks for 20 years, accumulating
364,000 miles. He holds a Class C operator's license from Pennsylvania.
His driving record for the last 3 years shows no crashes and no
convictions for moving violations in a CMV.

Albert Lewis

    Mr. Lewis, 65, has a prosthetic left eye due to a retinal
detachment since 1980. The best corrected visual acuity in his right
eye is 20/20. Following an examination in 2011, his optometrist noted,
``In my professional opinion, Albert Lewis has stable vision and should
continue to be able to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Lewis reported that he has driven straight
trucks for 9 years, accumulating 270,000 miles, and tractor-trailer
combinations for 16 years, accumulating 1.3 million miles. He holds a
Class A CDL from Alabama. His driving record for the last 3 years shows
no crashes and one conviction for speeding in a CMV; he exceeded the
speed limit by 21 mph.

John B. Middleton

    Mr. Middleton, 70, has had retinal telangiectasis in his left eye
since the 1980s. The best corrected visual acuity in his right eye is
20/20, and in his left eye, 20/80. Following an examination in 2012,
his optometrist noted, ``He has sufficient vision to perform tasks
required to operate a commercial vehicle.'' Mr. Middleton reported that
he has driven straight trucks for 3 years, accumulating 36,000 miles,
and tractor-trailer combinations for 52 years, accumulating 5.2 million
miles. He holds a Class A CDL from Ohio. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Ronald W. Patten

    Mr. Patten, 59, has had retinal scarring in his left eye due to a
traumatic injury sustained as a child. The best corrected visual acuity
in his right eye is 20/20, and in his left eye, hand motion vision.
Following an examination in 2012, his optometrist noted, ``In my
medical opinion, Ronald Patten has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Patten
reported that he has driven straight trucks for 9 years, accumulating
315,000 miles, and tractor-trailer combinations for 32 years,
accumulating 3.4 million miles. He holds a Class A CDL from Maine. His
driving record for the last 3 years shows no crashes and no convictions
for moving violations in a CMV.

Kirk W. Scott

    Mr. Scott, 42, has had glaucoma in his right eye due to a traumatic
injury sustained in 1981. The visual acuity in his right eye is no
light perception, and in his left eye, 20/20. Following an examination
in 2012, his optometrist noted, ``In my medical opinion the applicant
has sufficient vision to perform the driving tasks require to operate a
commercial vehicle.'' Mr. Scott reported that he has driven straight
trucks for 5 years, accumulating 48,000 miles, and tractor-trailer
combinations for 5 years, accumulating 288,000 miles. He holds a Class
A CDL from Connecticut. His driving record for the last 3 years shows
no crashes and no convictions for moving violations in a CMV.

Michael F. Sprouse

    Mr. Sprouse, 52, has had loss of vision in his right eye due to a
traumatic injury sustained in 1992. The best corrected visual acuity in
his right eye is 20/200, and in his left eye, 20/20. Following an
examination in 2012, his optometrist noted, ``Mr. Sprouse has
sufficient enough vision to perform the tasks necessary to drive a
commercial vehicle.'' Mr. Sprouse reported that he has driven tractor-
trailer combinations for 20 years, accumulating 1.3 million miles. He
holds a Class A CDL from South Carolina. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

John C. Steedley

    Mr. Steedley, 48, has had refractive amblyopia in his right eye
since childhood. The best corrected visual acuity in his right eye is
20/60, and in his left eye, 20/20. Following an examination in 2012,
his optometrist noted, ``In my medical opinion, Mr. Steedley has
sufficient vision to perform the driving task required to operate a
commercial vehicle.'' Mr. Steedley reported that he has driven tractor-
trailer combinations for 26 years, accumulating 1 million miles. He
holds a Class A CDL from Georgia. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. The Agency will consider all comments
received before the close of business September 5, 2012. Comments will
be available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable.
    In addition to late comments, FMCSA will also continue to file, in
the public docket, relevant information that becomes available after
the comment closing date. Interested persons should monitor the public
docket for new material.

    Issued on: July 27, 2012.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2012-19123 Filed 8-3-12; 8:45 am]
BILLING CODE 4910-EX-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY

NATIONAL VEHICLE AND FUEL EMISSIONS LABORATORY

2000 TRAVERWOOD DRIVE

ANN ARBOR, MI  48105-2498

									     OFFICE OF

									AIR AND RADIATION

3/10/16

MEMORANDUM

SUBJECT: Test Procedure Review with Cummins, Volvo, Navistar, Paccar, Daimler Eaton and Allison

FROM: James Sanchez

TO:  Greenhouse Gas Emissions Standards and Fuel Efficiency Standards for Medium- and

Heavy-Duty Engines and Vehicles - Phase 2 - Docket EPA-HQ-OAR-2014-0827

This memo documents communication on March 10, 2016 between representatives of Cummins, Volvo, Navistar, Paccar, Eaton, Allison, Daimler, Caterpillar, Hino, EMA and EPA to discuss heavy-duty test procedures proposed in the Phase 2 greenhouse gas and fuel efficiency standards for heavy-duty vehicles notice of proposed rulemaking.

Participants:

Allison –

Caterpillar –

Cummins – Jackie Yeager, Jon Dickson

Daimler – Gerald Freitag, David Kayes, Inderpal Singh

Eaton –

EMA –

EPA – Houshun Zhang

Hino – Mark Siddall

Navistar – Dave Gardner, Cortney Guzlas, Matt Hunkler

PACCAR – Mark Malowicki, Dan Kieffer, Erin Luke

Volvo – Marc Miller, Tim Connors, Chuck Kaslavage

Discussion and follow-up items (with owner's name in bold):

Road grade evaluation

EPA investigating two possible changes:

Relax overshoot constraint by changing GEM driver model PI controller.  Considering allowing between 3-5 mph overshoot going downhill.

Chop road grade on each hill so peaks will be reduced.

EPA analyzing these changes and requested companies to do the same.

Matt H. and Gerald presented Navistar and DTNA analyses of Profile D compared to their vehicle data – similar conclusions.

Some companies looking at longer cycles.  Discussed whether it is critical to maintain same cycle length and how much increase might be acceptable – hard to answer right now.

GEM update

Executable corresponding to NODA version should be available week of March 14.

Company request for GEM to accept input of user cycles.

Topics for future calls:

(TBD) SwRI results (N13 365, gasoline engine) – Houshun

(3/24) Road grade evaluation (analysis of GEM changes)  – EPA

(3/24) Road grade evaluation – Industry TBD


[Federal Register Volume 87, Number 8 (Wednesday, January 12, 2022)]
[Notices]
[Pages 1748-1750]
[FR Doc No: 2022-00359]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP22-24-000]

Equitrans L.P.; Notice of Scoping Period Requesting Comments on
Environmental Issues for the Proposed Truittsburg Well Conversion
Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) will prepare an environmental document that will discuss
the environmental impacts of the Truittsburg Well Conversion Project
involving construction and operation of facilities by Equitrans L.P.
(Equitrans) in Clarion County, Pennsylvania. The Commission will use
this environmental document in its decision-making process to determine
whether the project is in the public convenience and necessity.
    This notice announces the opening of the scoping process the
Commission will use to gather input from the public and interested
agencies regarding the project. As part of the National Environmental
Policy Act (NEPA) review process, the Commission takes into account
concerns the public may have about proposals and the environmental
impacts that could result from its action whenever it considers the
issuance of a Certificate of Public Convenience and Necessity. This
gathering of public input is referred to as ``scoping.'' The main goal
of the scoping process is to focus the analysis in the environmental
document on the important environmental issues. Additional information
about the Commission's NEPA process is described below in the NEPA
Process and Environmental Document section of this notice.
    By this notice, the Commission requests public comments on the
scope of issues to address in the environmental document. To ensure
that your comments are timely and properly recorded, please submit your
comments so that the Commission receives them in Washington, DC on or
before 5:00 p.m. Eastern Time on February 4, 2022. Comments may be
submitted in written form. Further details on how to submit comments
are provided in the Public Participation section of this notice.
    Your comments should focus on the potential environmental effects,
reasonable alternatives, and measures to avoid or lessen environmental
impacts. Your input will help the Commission staff determine what
issues they need to evaluate in the environmental document. Commission
staff will consider all written comments during the preparation of the
environmental document.
    If you submitted comments on this project to the Commission before
the opening of this docket on December 13, 2022, you will need to file
those comments in Docket No. CP22-24-000 to ensure they are considered
as part of this proceeding.
    This notice is being sent to the Commission's current environmental
mailing list for this project. State and local government
representatives should notify their constituents of this proposed
project and encourage them to comment on their areas of concern.
    If you are a landowner receiving this notice, a pipeline company
representative may contact you about the acquisition of an easement to
construct, operate, and maintain the proposed facilities. The company
would seek to negotiate a mutually acceptable easement agreement. You
are not required to enter into an agreement. However, if the Commission
approves the project, the Natural Gas Act conveys the right of eminent
domain to the company. Therefore, if you and the company do not reach
an easement agreement, the pipeline company could initiate condemnation
proceedings in court. In such instances, compensation would be
determined by a judge in accordance with state law. The Commission does
not subsequently grant, exercise, or oversee the exercise of that
eminent domain authority. The courts have exclusive authority to handle
eminent domain cases; the Commission has no jurisdiction over these
matters.
    Equitrans provided landowners with a fact sheet prepared by the
FERC entitled ``An Interstate Natural Gas Facility On My Land? What Do
I Need To Know?'' which addresses typically asked questions, including
the use of eminent domain and how to participate in the Commission's
proceedings. This fact sheet along with other landowner topics of
interest are available for viewing on the FERC website (www.ferc.gov)
under the Natural Gas Questions or Landowner Topics link.

Public Participation

    There are three methods you can use to submit your comments to the
Commission. Please carefully follow these instructions so that your
comments are properly recorded. The Commission encourages electronic
filing of comments and has staff available to assist you at (866) 208-
3676 or [email protected].

    (1) You can file your comments electronically using the eComment
feature, which is located on the Commission's website (www.ferc.gov)
under the link to FERC Online. Using eComment is an easy method for
submitting brief, text-only comments on a project;
    (2) You can file your comments electronically by using the eFiling
feature, which is located on the Commission's website (www.ferc.gov)
under the link to FERC Online. With eFiling, you can provide comments
in a variety of formats by attaching them as a file with your
submission. New eFiling users must first create an account by clicking
on ``eRegister.'' You will be asked to select the type of filing you
are making; a comment on a particular project is considered a ``Comment
on a Filing''; or
    (3) You can file a paper copy of your comments by mailing them to
the Commission. Be sure to reference the project docket number (CP22-
24-000) on your letter. Submissions sent via the U.S. Postal Service
must be addressed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street NE, Room 1A, Washington, DC
20426. Submissions sent via any other carrier must be addressed to:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission,
12225 Wilkins Avenue, Rockville, MD 20852.
    Additionally, the Commission offers a free service called
eSubscription which makes it easy to stay informed of all issuances and
submittals regarding the dockets/projects to which you subscribe. These
instant email notifications are the fastest way to receive notification
and provide a link to the document files which can reduce the amount of
time you spend researching proceedings. Go to https://www.ferc.gov/ferc-online/overview to register for eSubscription.

Summary of the Proposed Project

    Equitrans is proposing to convert two observation wells into
injection/withdrawal (I/W) wells in the existing Truittsburg Storage
Field. Specifically, Equitrans is proposing to add approximately 1,119
feet of 4-inch-diameter natural gas pipeline to convert Truittsburg
wells 2483 and 2484 from observation wells to I/W wells and install
pigging \1\ valves at the wellheads and associated piping. According to
Equitrans, the purpose for the project is to transport gas from the
wells to the main storage trunk line thereby increasing working gas
capacity at the Truittsburg Storage Field.
---------------------------------------------------------------------------

    \1\ A ``pig'' is a tool that the pipeline company inserts into
and pushes through the pipeline for cleaning the pipeline,
conducting internal inspections, or other purposes.
---------------------------------------------------------------------------

    The general location of the project facilities is shown in appendix
1.\2\
---------------------------------------------------------------------------

    \2\ The appendices referenced in this notice will not appear in
the Federal Register. Copies of the appendices were sent to all
those receiving this notice in the mail and are available at
www.ferc.gov using the link called ``eLibrary.'' For instructions on
connecting to eLibrary, refer to the last page of this notice. At
this time, the Commission has suspended access to the Commission's
Public Reference Room due to the proclamation declaring a National
Emergency concerning the Novel Coronavirus Disease (COVID-19),
issued by the President on March 13, 2020. For assistance, contact
FERC at [email protected] or call toll free,<PHONE_NUMBER>
or TTY<PHONE_NUMBER>.
---------------------------------------------------------------------------

Land Requirements for Construction

    The project would result in temporary impacts on 1.44 acres, with
no permanent land impacts. Construction activities would require the
use of 831 feet of existing permanent access roads and 1.44 acres of
new pipeline right-of-way and temporary workspace.

NEPA Process and the Environmental Document

    Any environmental document issued by the Commission will discuss
impacts that could occur as a result of the construction and operation
of the proposed project under the relevant general resource areas:
     Geology and soils;
     water resources and wetlands;
     vegetation and wildlife;
     threatened and endangered species;
     cultural resources;
     land use;
     socioeconomics;
     environmental justice;
     air quality and noise; and
     reliability and safety.
    Commission staff will also evaluate reasonable alternatives to the
proposed project or portions of the project and make recommendations on
how to lessen or avoid impacts on the various resource areas. Your
comments will help Commission staff identify and focus on the issues
that might have an effect on the human environment and potentially
eliminate others from further study and discussion in the environmental
document.
    Following this scoping period, Commission staff will determine
whether to prepare an Environmental Assessment (EA) or an Environmental
Impact Statement (EIS). The EA or the EIS will present Commission
staff's independent analysis of the issues. If Commission staff
prepares an EA, a Notice of Schedule for the Preparation of an
Environmental Assessment will be issued. The EA may be issued for an
allotted public comment period. The Commission would consider timely
comments on the EA before making its decision regarding the proposed
project. If Commission staff prepares an EIS, a Notice of Intent to
Prepare an EIS/Notice of Schedule will be issued, which will open up an
additional comment period. Staff will then prepare a draft EIS which
will be issued for public comment. Commission staff will consider all
timely comments received during the comment period on the draft EIS and
revise the document, as necessary, before issuing a final EIS. Any EA
or draft and final EIS will be available in electronic format in the
public record through eLibrary \3\ and the Commission's natural gas
environmental documents web page (https://www.ferc.gov/industries-data/natural-gas/environment/environmental-documents). If eSubscribed, you
will receive instant email notification when the environmental document
is issued.
---------------------------------------------------------------------------

    \3\ For instructions on connecting to eLibrary, refer to the
last page of this notice.
---------------------------------------------------------------------------

    With this notice, the Commission is asking agencies with
jurisdiction by law and/or special expertise with respect to the
environmental issues of this project to formally cooperate in the
preparation of the environmental document.\4\ Agencies that would like
to request cooperating agency status should follow the instructions for
filing comments provided under the Public Participation section of this
notice.
---------------------------------------------------------------------------

    \4\ The Council on Environmental Quality regulations addressing
cooperating agency responsibilities are at Title 40, Code of Federal
Regulations, Section 1501.8.
---------------------------------------------------------------------------

Consultation Under Section 106 of the National Historic Preservation
Act

    In accordance with the Advisory Council on Historic Preservation's
implementing regulations for section 106 of the National Historic
Preservation Act, the Commission is using this notice to initiate
consultation with the applicable State Historic Preservation Office,
and to solicit their views and those of other government agencies,
interested Indian tribes, and the public on the project's potential
effects on historic properties.\5\ The environmental document for this
project will document findings on the impacts on historic properties
and summarize the status of consultations under section 106.
---------------------------------------------------------------------------

    \5\ The Advisory Council on Historic Preservation's regulations
are at Title 36, Code of Federal Regulations, Part 800. Those
regulations define historic properties as any prehistoric or
historic district, site, building, structure, or object included in
or eligible for inclusion in the National Register of Historic
Places.

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

Environmental Mailing List

    The environmental mailing list includes federal, state, and local
government representatives and agencies; elected officials;
environmental and public interest groups; Native American Tribes; other
interested parties; and local libraries and newspapers. This list also
includes all affected landowners (as defined in the Commission's
regulations) who are potential right-of-way grantors, whose property
may be used temporarily for project purposes, or who own homes within
certain distances of aboveground facilities, and anyone who submits
comments on the project and includes a mailing address with their
comments. Commission staff will update the environmental mailing list
as the analysis proceeds to ensure that Commission notices related to
this environmental review are sent to all individuals, organizations,
and government entities interested in and/or potentially affected by
the proposed project.
    If you need to make changes to your name/address, or if you would
like to remove your name from the mailing list, please complete one of
the following steps:
    (1) Send an email to GasProjectAddressCh[email protected] stating your
request. You must include the docket number CP22-24-000 in your
request. If you are requesting a change to your address, please be sure
to include your name and the correct address. If you are requesting to
delete your address from the mailing list, please include your name and
address as it appeared on this notice. This email address is unable to
accept comments.
    Or
    (2) Return the attached ``Mailing List Update Form'' (appendix 2).

Additional Information

    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC website at www.ferc.gov using the eLibrary link. Click on the
eLibrary link, click on ``General Search'' and enter the docket number
in the ``Docket Number'' field. Be sure you have selected an
appropriate date range. For assistance, please contact FERC Online
Support at [email protected] or<PHONE_NUMBER>, or for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of all formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    Public sessions or site visits will be posted on the Commission's
calendar located at https://www.ferc.gov/news-events/events along with
other related information.

    Dated: January 5, 2022.
Kimberly D. Bose,
Secretary.
[FR Doc. 2022-00359 Filed 1-11-22; 8:45 am]
BILLING CODE 6717-01-P


Comment Info: =================

General Comment:Re: Request for Extension of Comment Period: Docket No. FDA-2014-N-0189

As owners of JRILY Enterprises, LLC, DBA eJuiceMonkeys, we’ve conducted a preliminary review of the 240-page proposed regulations. We respectfully request the Food and Drug Administration (FDA) extend the comment period for proposed rule “Deeming Tobacco Products to be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Regulations on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products.”

We are a small liquid manufacturer and online retailer/distributor, employing fewer than 350 people. We started eJuiceMonkeys as a result of our own personal experience with personal vaporizers (electronic cigarettes), and we have grown to unexpected levels without advertising or marketing. This is because we provide customers a quality product with responsible, continuous support. Our growth means we now contribute to our economy in a much larger way. We provide double the federal minimum wage jobs, generate our own income, make repeated large purchases from other domestic businesses, support charitable organizations and pay over $100,000 annually in state and federal taxes.

The preamble to the proposed rule identifies approximately 70 topics and issues the Agency requests comments on. Many of these issues are complex and difficult, and relate to an extremely diverse array of products. Clearly, the lengthy time period the Agency required to formulate and propose these regulations is evidence that the issues in the proposal are multi-faceted and challenging. FDA cannot expect any interested party, and in particular, any manufacturer, to conduct a meaningful review and analysis allowing detailed and thoughtful comment in such a short period.

The  initial 75-day comment period for the proposed rule simply does not provide enough time for emerging, small businesses like ours to adequately analyze the entire proposal, or provide substantive comments on the numerous questions posed in it. We need more time to address items in the 240-page document, as they will deal a devastating economic blow to our business, and may well close its doors.

Therefore, eJuiceMonkeys again respectfully requests the FDA extend the comment period to 180 days. This will help ensure the final rule is based on adequate and meaningful administrative records. Thank you in advance for your consideration of this request.

Sincerely,

Sharon A. Goodson Alan W. Goodson Co-owners JRILY Enterprises LLC, DBA eJuiceMonkeys


[Federal Register Volume 78, Number 59 (Wednesday, March 27, 2013)]
[Notices]
[Pages 18605-18609]
[FR Doc No: 2013-07032]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0297]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Prevention of Salmonella Enteritidis in Shell Eggs
During Production--Recordkeeping and Registration Provisions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing an
opportunity for public comment on our proposed collection of certain
information. Under the Paperwork Reduction Act of 1995 (the

PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection provisions of
FDA's recordkeeping and registration requirements for shell egg
producers.

DATES: Submit either electronic or written comments on the collection
of information by May 28, 2013.

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

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, we are publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, we invite
comments on these topics: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.

Prevention of Salmonella Enteritidis in Shell Eggs During Production--
Recordkeeping and Registration Provisions--21 CFR 118.10 and 118.11
(OMB Control Number 0910-0660)--Extension

    Shell eggs contaminated with Salmonella Enteritidis (SE) are
responsible for more than 140,000 illnesses per year. The Public Health
Service Act (PHS Act) authorizes the Secretary of Health and Human
Services to make and enforce such regulations as ``are necessary to
prevent the introduction, transmission, or spread of communicable
diseases from foreign countries into the States * * * or from one State
* * * into any other State'' (section 361(a) of the PHS Act). This
authority has been delegated to the Commissioner of Food and Drugs.
Under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 342(a)(4)), a food is adulterated if it is
prepared, packed, or held under insanitary conditions whereby it may
have been contaminated with filth or rendered injurious to health.
Under section 701(a) of the FD&C Act (21 U.S.C. 371(a)), FDA is
authorized to issue regulations for the efficient enforcement of the
FD&C Act.
    On July 9, 2009, FDA published in the Federal Register a final rule
that established a regulation at part 118 (21 CFR part 118) entitled
``Prevention of Salmonella Enteritidis in Shell Eggs During Production,
Storage, and Transportation'' (74 FR 33030) (the Shell Eggs final
rule). Part 118 requires shell egg producers to implement measures to
prevent SE from contaminating eggs on the farm and from further growth
during storage and transportation, and requires these producers to
maintain records concerning their compliance with the rule and to
register with FDA. As described in more detail with regard to each
information collection provision of part 118, each farm site with 3,000
or more egg-laying hens that sells raw shell eggs to the table egg
market, other than directly to the consumer, must refrigerate,
register, and keep certain records. Farms that do not send all of their
eggs to treatment are also required to have an SE prevention plan and
to test for SE.
    Section 118.10 of FDA's regulations requires recordkeeping for all
measures the farm takes to prevent SE in its flocks. Since many
existing farms participate in voluntary egg quality assurance programs,
those respondents may not have to collect any additional information.
Records are maintained on file at each farm site and examined there
periodically by FDA inspectors.
    Section 118.10 also requires each farm site with 3,000 or more egg-
laying hens that sells raw shell eggs to the table egg market, other
than directly to the consumer, and does not have all of the shell eggs
treated, to design and implement an SE prevention plan. Section 118.10
requires recordkeeping for each of the provisions included in the plan
and for plan review and modifications if corrective actions are taken.
    Finally, Sec.  118.11 of FDA's regulations requires that each farm
covered by Sec.  118.1(a) register with FDA using Form FDA 3733. The
term ``Form FDA 3733'' refers to both the paper version of the form and
the electronic system known as the Shell Egg Producer Registration
Module, which is available at http://www.access.fda.gov. The Agency
strongly encourages electronic registration because it is faster and
more convenient. The system the Agency has developed can accept
electronic registrations 24 hours a day, 7 days a week. A registering
shell egg producer will receive confirmation of electronic registration
instantaneously once all the required fields on the registration screen
are completed. However, paper registrations will also be accepted. Form
FDA 3733 is available for download for registration for submission by
mail or CD-ROM (see http://www.fda.gov/Food/GuidanceRegulation/FoodFacilityRegistration/ShellEggProducerRegistration/ucm217952.htm#cdrom).
    Recordkeeping and registration are necessary for the success of the
SE prevention measures. Written SE prevention plans and records of
actions taken due to each provision are essential for farms to
implement SE prevention plans effectively. Further, they are essential
for us to be able to determine compliance. Information provided under
these regulations helps us to notify quickly the facilities that might
be affected by a deliberate or accidental contamination of the food
supply. In addition, data collected through registration is used to
support our enforcement activities.
    Description of Respondents: Respondents to this information
collection include farm sites with 3,000 or more egg-laying hens that
sell raw

eggs to the table egg market, other than directly to the consumer.
    We estimate the burden of this collection of information as
follows:

Recordkeeping Burden

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                      No. of      No. of records                      Average
 Description and 21 CFR section    recordkeepers        per        Total annual     burden per      Total hours
                                        \2\        recordkeeper       records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Refrigeration Records, Sec.                2,600              52         135,200             0.5          67,600
 118.10(a)(3)(iv)...............
Testing, Diversion, and                      343              52          17,836             0.5           8,918
 Treatment Records, Sec.
 118.10(a)(3)(v) to (a)(3)(viii)
 (positive) \3\.................
Egg Testing, Sec.                            331               7           2,317             8.3          19,231
 118.10(a)(3)(vii)..............
Environmental Testing, Sec.                6,308              23         145,084            0.25          36,271
 118.10(a)(3)(v) \3\............
Testing, Diversion, and                    5,965               1           5,965             0.5           2,983
 Treatment Records, Sec.
 118.10(a)(3)(v) to (a)(3)(viii)
 (negative) \3\.................
Prevention Plan Review and                   331               1             331              10           3,310
 Modifications, Sec.
 118.10(a)(4)...................
Chick and Pullet Procurement               4,731               1           4,731             0.5           2,366
 Records, Sec.   118.10(a)(2)...
Rodent and Other Pest Control,             9,462              52         492,024             0.5         246,012
 Sec.   118.10(a)(3)(ii), and
 Biosecurity Records, Sec.
 118.10(a)(3)(i)................
Prevention Plan Design, Sec.                 150               1             150              20           3,000
 118.10(a)(1)...................
Cleaning and Disinfection                    331               1             331             0.5             166
 Records, Sec.
 118.10(a)(3)(iii)..............
                                 -------------------------------------------------------------------------------
    Total hours.................  ..............  ..............  ..............  ..............        389,857
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ Some records are kept on a by-farm basis and others are kept on a by-house basis.
\3\ Calculations include requirements for pullet and layer houses.

    FDA is retaining most of the estimates published in the Shell Eggs
final rule with regard to the estimated number of respondents and the
average burden per recordkeeping (74 FR 33030 at 33089 to 33091). FDA
bases the remaining recordkeeping burden estimates and the reporting
burden estimates on its experience implementing the final rule and the
number of registrations and cancellations received in the past 3 years.
    The number of recordkeepers estimated in column 2 of table 1 and
all other estimates discussed in this section are drawn from estimates
of the total number of layer and pullet houses affected by the Shell
Eggs final rule (74 FR 33030 at 33078 to 33080). In the final rule, we
assumed that those farms that were operating according to recognized
industry or State quality assurance plans were already largely in
compliance with the plan design and recordkeeping provisions discussed
in this section, and therefore would not experience additional costs to
comply with recordkeeping provisions. We found that 59 percent of farms
with more than 50,000 layers were members of State or industry quality
assurance plans. Fewer than 8 percent of farms with fewer than 50,000
layers were members of quality assurance plans. Thus, we estimated the
number of layer farms incurring a new recordkeeping burden because of
the Shell Eggs final rule to be 2,600, and the number of houses
affected to be 4,731. A detailed breakdown of this estimation is shown
in table 29 of the Shell Eggs final rule (74 FR 33030 at 33078).
    Prevention plan design (Sec.  118.10(a)(1)) records will be kept on
a per farm basis but because the Shell Eggs final rule has been fully
implemented, FDA assumes that new prevention plan design will only be
undertaken by new entrants to the industry. Refrigeration records
(Sec.  118.10(a)(3)(iv)) will also be kept on a per farm basis so the
estimated number of recordkeepers for this provision is 2,600.
    Records of chick and pullet procurement (Sec.  118.10(a)(2)),
rodent and other pest control (Sec.  118.10(a)(3)(ii)), and biosecurity
(Sec.  118.10(a)(3)(i)) will be kept on a per house basis, so the
estimated number of recordkeepers for these provisions is 4,731.
    Records of cleaning and disinfection (Sec.  118.10(a)(3)(iii)) will
also be kept on a per house basis, but will only need to be kept in the
event that a layer house tests environmentally positive for SE.
Prevention plan review and modifications (Sec.  118.10(a)(4)) will also
need to be performed every time a house tests positive. As discussed in
section V.F of the Shell Eggs final rule (74 FR 33030 at 33078 to
33080), FDA estimated that 7.0 percent will test positive after the
provisions of the rule took effect. Therefore, the number of
recordkeepers for these provisions is estimated to be 331 (4,731 houses
x 0.070) annually.
    Records of testing, diversion, and treatment (118.10(a)(3)(v) to
(a)(3)(viii)) will be kept on a per house basis and will include
records on flocks from pullet houses. In the Shell Eggs final rule, FDA
estimated that there are one third as many pullet houses as there are
layer houses. Therefore the total number of recordkeepers for these
provisions is 6,308 (4,731 + (4,731/3)). The number of annual records
kept depends on whether or not houses test positive for SE. Annually,
343 layer and pullet houses ((4,731 layer houses x 0.070) + ((4731/3
pullet houses) x 0.0075)) are expected to test positive and 5,965 are
expected to test negative ((4,731 layer houses x 0.930) + ((4731/3
pullet houses) x 0.9925)).
    We assume that refrigeration records will be kept on a weekly basis
on a per farm basis under Sec.  118.10(a)(3)(iv)). We estimate that
2,600 recordkeepers will maintain 52 records each for a total of
135,200 records and that it will take approximately 0.5 hour per
recordkeeping. Thus, the total annual burden for refrigeration records
is estimated to be 67,600 hours (135,200 x 0.5 hour).
    We assume that records of testing, diversion, and treatment under
Sec.  118.10(a)(3)(v) to (a)(3)(viii)) will be kept weekly in the event
a layer house tests environmentally positive for SE. We estimate that
343 layer and pullet houses will test positive and thus 343
recordkeepers will maintain 52 records each for a total of 17,836
records and that it will take approximately 0.5 hour per recordkeeping.
Thus, the total annual burden for testing, diversion, and treatment
records in the event of a positive test result is estimated to be 8,918
hours (17,836 x 0.5 hour).
    Given a positive environmental test for SE., we estimate the
weighted average number of egg tests per house

under Sec.  118.10(a)(3)(vii)) to be 7. We estimate that 331
recordkeepers will maintain 7 records each for a total of 2,317 records
and that it will take approximately 8.3 hours per recordkeeping. Thus,
the total annual burden for egg testing is estimated to be 19,231 hours
(2,317 x 8.3 hours).
    FDA estimates that all 1,577 pullet and 4,731 layer houses not
currently testing (6,308 recordkeepers) will incur the burden of a
single environmental test annually under Sec.  118.10(a)(3)(v)). The
number of samples taken during the test depends on whether a farm
employs the row based method (an average of 12 samples per house) or
the random sampling method (32 samples per house). For the purposes of
this analysis we estimate that roughly 50 percent of the houses
affected will employ a row based method and 50 percent will employ a
random sampling method, implying an average of 23 samples per house.
Thus, we estimate that 6,308 recordkeepers will take 23 samples each
for a total of 145,084 samples. The time burden of sampling is
estimated on a per swab sample basis. We estimate that it will take
approximately 15 minutes to collect and pack each sample. Thus, the
total annual burden for environmental testing is estimated to be
36,271hours (145,084 x 0.25 hour).
    We estimate that records of testing, diversion, and treatment under
Sec.  118.10(a)(3)(v) to (a)(3)(viii) will be kept annually in the
event a layer house tests environmentally negative for SE. We estimate
that 5,965 layer and pullet houses will test negative and thus 5,965
recordkeepers will maintain one record of that testing that will take
approximately 0.5 hour per record. Thus, the total annual burden for
testing, diversion, and treatment records in the event of a negative
test result is estimated to be 2,983 hours (5,965 x 0.5 hour).
    Prevention plan review and modifications under Sec.  118.10(a)(4)
will need to be performed every time a house tests positive. As
discussed, we estimate that 331 layer houses will test positive
requiring plan review and modifications and that it will take 10 hours
to complete this work. Thus, the total annual burden for prevention
plan review and modifications in the event of a positive test result is
estimated to be 3,310 hours (331 x 10 hours).
    We estimate that chick and pullet procurement records under Sec.
118.10(a)(2) will be kept roughly once annually per layer house basis.
We estimate that 4,731 layer houses will maintain 1 record each and
that it will take approximately 0.5 hour per recordkeeping. Thus, the
total annual burden for chick and pullet procurement recordkeeping is
estimated to be 2,366 hours (4,731 x 0.5 hour).
    We estimate that rodent and other pest control records under Sec.
118.10(a)(3)(ii)) and biosecurity records under Sec.  118.10(a)(3)(i)
will be kept weekly on a per layer house basis. We assume that 4,731
layer houses will maintain a weekly record under each provision. Thus,
we estimate 9,462 recordkeepers will maintain 52 records each for a
total of 492,024 records. We estimate a recordkeeping burden of 0.5
hours per record for a total of 246,012 burden hours (492,024 x 0.5
hour).
    New prevention plan design required by Sec.  118.10(a)(1) will only
be undertaken by new farms and records will be kept on a per farm
basis. We estimate that there are 150 new farm registrations annually
and we assume that this reflects 150 new farms requiring prevention
plan design. We estimate that it will take 20 hours to complete this
work. Thus, the total annual burden for prevention plan design is
estimated to be 3,000 hours (150 x 20 hours).
    Cleaning and disinfection recordkeeping under Sec.
118.10(a)(3)(iii) will need to be performed every time a house tests
positive. As discussed, we estimate that 331 layer houses will test
positive requiring 1 record each and that it will take approximately
0.5 hour per recordkeeping. Thus, the total annual burden for cleaning
and disinfection recordkeeping in the event of a positive test result
is estimated to be 166 hours (331 x 0.5 hour).

Reporting Burden

                                                     Table 2--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                No. of
      Description and 21 CFR section                FDA form No.              No. of       responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Registrations or Updates, Sec.   118.11...  Form FDA 3733 \2\...........             150               1             150             2.3             345
Cancellations, Sec.   118.11..............  Form FDA 3733...............              15               1              15               1              15
                                           -------------------------------------------------------------------------------------------------------------
    Total.................................  ............................  ..............  ..............  ..............  ..............             360
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ The term ``Form FDA 3733'' refers to both the paper version of the form and the electronic system known as the Shell Egg Producer Registration
  Module, which is available at http://www.access.fda.gov per Sec.   118.11(b)(1).

    This estimate is based on FDA's experience implementing the Shell
Eggs final rule and the average number of new Shell Egg Producer
registrations and cancellations received in the past 3 years under
Sec.  118.11. Based on FDA experience with implementing the
registration provisions of the Shell Eggs final rule, which had
staggered compliance dates and gave producers with fewer than 50,000
but at least 3,000 laying hens until July 9, 2012, to register (74 FR
33030 at 33034), FDA expects that it will receive fewer registrations
or updates each year over the next 3 years, reflecting compliance with
the final rule's registration deadlines. FDA estimates that it will
receive 200 registrations or updates in 2013, 150 registrations or
updates in 2014, and 100 registrations or updates in 2015, for an
average of 150 registrations or updates per year over the next 3 years.
FDA received 12 cancellations in 2011 and 19 cancellations in 2012.
Based on this experience, FDA estimates that it will receive
approximately 15 cancellations per year over the next 3 years.
    FDA estimated in the Shell Eggs final rule that listing the
information required by the final rule and presenting it in a format
that will meet the Agency's registration regulations will require a
burden of approximately 2.3 hours per average registration. As detailed
in section V.F of the final rule (see 74 FR 33030 at 33080), FDA
estimates that it will take the average farm 2.3 hours to register
taking into account that some respondents completing the registration
may not have readily available Internet access. Thus, the total annual
burden for new Shell Egg Producer registrations or updates is estimated
to be 345 hours (150 x 2.3 hours).
    FDA estimates cancelling a registration will, on average, require a

burden of approximately 1 hour, taking into account that some
respondents may not have readily available Internet access. Thus, the
total annual burden for cancelling Shell Egg Producer registrations is
estimated to be 15 hours (15 cancellations x 1 hour).

    Dated: March 20, 2013.
Peter Lurie,
Acting Associate Commissioner for Policy and Planning.
[FR Doc. 2013-07032 Filed 3-26-13; 8:45 am]
BILLING CODE 4160-01-P