[Federal Register Volume 80, Number 194 (Wednesday, October 7, 2015)]
[Notices]
[Pages 60747-60749]
[FR Doc No: 2015-25497]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2014-0104]

Qualification of Drivers; Application for Exemptions; Hearing

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to grant requests from 17
individuals for exemptions from the Agency's physical qualifications
standard concerning hearing for interstate drivers. The current
regulation prohibits hearing impaired individuals from operating CMVs
in interstate commerce. After notice and opportunity for public
comment, the Agency concluded that granting exemptions for these
drivers to operate property-carrying CMVs will provide a level of
safety that is equivalent to or greater than the level of safety
maintained without the exemptions. The exemptions are valid for a 2-
year period and may be renewed. The exemptions preempt State laws and
regulations.

DATES: The exemptions are effective October 7, 2015. The exemptions
expire on October 10, 2017.

FOR FURTHER INFORMATION CONTACT: Charles A. Horan, III, Director,
Office of Carrier, Driver and Vehicle Safety,<PHONE_NUMBER>,
<EMAIL_ADDRESS>FMCSA, Department of Transportation, 1200 New
Jersey Avenue SE., Room W64-224, Washington, DC 20590-0001. Office
hours are 8:30 a.m. to 5 p.m., e.t., Monday through Friday, except
Federal holidays.

SUPPLEMENTARY INFORMATION:

A. Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to www.regulations.gov and/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., e.t., Monday through Friday, except Federal
holidays.
    Privacy Act: In accordance with 5 U.S.C. 553(c), DOT solicits
comments from the public to better inform its rulemaking process. DOT
posts these comments, without edit, including any personal information
the commenter provides, to www.regulations.gov, as described in the
system of records notice (DOT/ALL-14 FDMS), which can be reviewed at
www.dot.gov/privacy.

B. Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the 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.'' The statute also allows the Agency to renew exemptions at
the end of the 2-year period. The current provisions of the FMCSRs
concerning hearing state that a person is physically qualified to drive
a CMV if that person:

    First perceives a forced whispered voice in the better ear at
not less than 5 feet with or without the use of a hearing aid or, if
tested by use of an audiometric device, does not have an average
hearing loss in the better ear greater than 40 decibels at 500 Hz,
1,000 Hz, and 2,000 Hz with or without a hearing aid when the
audiometric device is calibrated to American National Standard
(formerly ASA Standard) Z24.5-1951.

    49 CFR 391.41(b)(11). This standard was adopted in 1970, with a
revision in 1971 to allow drivers to be qualified under this standard
while wearing a hearing aid, 35 FR 6458, 6463 (April 22, 1970) and 36
FR 12857 (July 3, 1971).
    FMCSA grants 17 individuals an exemption from Sec.  391.41(b)(11)
concerning hearing to enable them to operate property-carrying CMVs in
interstate commerce for a 2-year period. The Agency's decision on these
exemption applications is based on the current medical literature and
information and the ``Executive

Summary on Hearing, Vestibular Function and Commercial Motor Driving
Safety'' (the 2008 Evidence Report) presented to FMCSA on August 26,
2008. The evidence report reached two conclusions regarding the matter
of hearing loss and CMV driver safety: (1) No studies that examined the
relationship between hearing loss and crash risk exclusively among CMV
drivers were identified; and (2) evidence from studies of the private
driver license holder population does not support the contention that
individuals with hearing impairment are at an increased risk for a
crash. In addition, the Agency reviewed each applicant's driving record
found in the CDLIS,\1\ for CDL holders, and inspections recorded in
MCMIS.\2\ For non-CDL holders, the Agency reviewed the driving records
from the State licensing agency. Each applicant's record demonstrated a
safe driving history. The Agency believes the drivers covered by the
exemptions do not pose a risk to public safety.
---------------------------------------------------------------------------

    \1\ Commercial Driver License Information System (CDLIS) is an
information system that allows the exchange of commercial driver
licensing information among all the States. CDLIS includes the
databases of 51 licensing jurisdictions and the CDLIS Central Site,
all connected by a telecommunications network.
    \2\ Motor Carrier Management Information System (MCMIS) is an
information system that captures data from field offices through
SAFETYNET, CAPRI, and other sources. It is a source for FMCSA
inspection, crash, compliance review, safety audit, and registration
data.
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C. Comments

    On October 27, 2014, FMCSA published a notice of receipt of
exemption applications and requested public comment on 17 individuals
(FR 79 64004; Docket number FMCSA-2014-25453). The comment period ended
on November 26, 2014. In response to this notice, FMCSA received 10
comments. Six comments supported deaf drivers driving commercially and
four comments expressed safety concerns for granting exemptions to
drivers who do not meet the hearing standard. The safety concerns were
submitted on behalf of The American Trucking Associations, Inc.;
Schneider National, Inc.; Hub Group Trucking, Inc.; and Werner
Enterprises, Inc. Some of these comments were addressed in a previous
notice. These stakeholders expressed safety concerns for the far
reaching ramifications to the commercial driving industry of allowing
deaf drivers to test, train and/or drive commercially. Additionally
they expressed concern for the process by which exemptions are granted
from parts of 49 CFR 391.41, the increased volume of exemptions, and
the need to rely on scientific support as a basis for granting the
exemptions. FMCSA acknowledges the stakeholder's concerns and may
consider the initial steps to revising the physical qualification
standards through a formal rulemaking process.

D. Exemptions Granted

    Following individualized assessments of the exemption applications,
FMCSA grants exemptions from 49 CFR 391.41(b)(11) to 17 individuals.
Under current FMCSA regulations, all of the 17 drivers receiving
exemptions from 49 CFR 391.41(b)(11) would have been considered as
qualified physically to drive a CMV in interstate commerce except that
they do not meet the hearing requirement. FMCSA has determined that the
following 17 applicants should be granted an exemption:

Martin Anthony Bystrycki

    Mr. Bystrycki, 63, holds a Class A commercial driver's license
(CDL) in Florida.

Ronald Craver, Sr.

    Mr. Craver, 57, holds an operator's license in Texas.

Byron Davis

    Mr. Davis, 37, holds an operator's license in Mississippi.

Stephen Digiovanna

    Mr. Digiovanna, 53, holds a Class A commercial driver's license
(CDL) in Pennsylvania.

Bruce Howard Dunn

    Mr. Dunn, 52, holds a Class A commercial driver's license (CDL) in
Louisiana.

Brandon Thomas Londo

    Mr. Londo, 29, holds an operator's license in Texas.

George T. Moore

    Mr. Moore, 47, holds an operator's license in Georgia.

Robert J. Pippin

    Mr. Pippin, 46, holds an operator's license in South Dakota.

Scott A. Perdue

    Mr. Perdue, 47, holds a Class A commercial driver's license (CDL)
in Georgia.

Adalberto Rodriguez

    Mr. Rodriguez, 49, holds a Class A commercial driver's license
(CDL) in New York.

David Rodriguez

    Mr. Rodriguez, 56, holds an operator's license in Texas.

Melvin Randall Ross

    Mr. Ross, 61, holds a Class A commercial driver's license (CDL) in
Ohio.

Abderrazek Merjoune

    Mr. Merjoune, 42, holds a Class A commercial driver's license (CDL)
in Maryland.

Seth Lee Shannon

    Mr. Shannon, 36, holds an operator's license in Washington.

Thomas D. Sneer

    Mr. Sneer, 58, holds a Class A commercial driver's license (CDL) in
Minnesota.

Juan Sloan

    Mr. Sloan, 52, holds an operator's license in California.

Charles F. Wirick, IV

    Mr. Wirick, 31, holds an operator's license in Maryland.

Basis for Exemption

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the hearing standard in 49 CFR 391.41(b)(11) if the exemption is
likely to achieve an equivalent or greater level of safety than would
be achieved without the exemption. With the exemption, applicants can
drive in interstate commerce. Thus, the Agency's analysis focuses on
whether an equal or greater level of safety is likely to be achieved by
permitting each of these drivers to drive in interstate commerce as
opposed to restricting him or her to driving in intrastate commerce.
The driver must comply with the terms and conditions of the exemption.
This includes reporting any crashes or accidents as defined in 49 CFR
390.5 and reporting all citations and convictions for disqualifying
offenses under 49 CFR part 383 and 49 CFR 391.

Conclusion

    The Agency is granting exemptions from the hearing standard, 49 CFR
391.41(b)(11), to 17 individuals based on an evaluation of each
driver's safety experience. Safety analysis of information relating to
these 17 applicants meets the burden of showing that granting the
exemptions would achieve a level of safety that is equivalent to or
greater than the level that would be achieved without the exemption. In
accordance with 49 U.S.C. 31315, each exemption will be

valid for 2 years from the effective date with annual recertification
required unless revoked earlier by FMCSA. The exemption will be revoked
if the following occurs: (1) The person fails to comply with the terms
and conditions of the exemption; (2) the exemption has resulted in a
lower level of safety than was maintained prior to being granted; or
(3) continuation of the exemption would not be consistent with the
goals and objectives of 49 U.S.C. 31136 and 31315.
    FMCSA exempts the following 17 drivers for a period of 2 years from
the physical qualification standard concerning hearing: Martin Anthony
Bystrycki (FL); Ronald Craver, Sr. (TX); Byron Davis (MS); Stephen
Digiovanna (PA); Bruce Howard Dunn (LA); Brandon Thomas Londo (TX);
George T. Moore (GA); Robert J. Pippin (SD); Scott A. Perdue (GA);
Adalberto Rodriguez (NY); David Rodriguez (TX); Melvin Randall Ross
(OH); Abderrazek Merjoune (MD); Seth Lee Shannon (WA); Thomas D. Sneer
(MN); Juan Sloan (CA); and Charles F. Wirick, IV (MD).

    Issued on: September 29, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-25497 Filed 10-6-15; 8:45 am]
 BILLING CODE 4910-EX-P


From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Date:	08/12/2010 05:47 PM

Subject:	RE: EPA and NHTSA HD Fuel Efficiency and GHG Draft RIA - Combined File

Hi Chandana,

Yes, I will be the main contact for EPA.   You should feel free to call me anytime.  If you miss me in my office, don't hesitate to call my cellphone.

Thanks,

Byron

******************************************************************

Byron Bunker

Center Director - Heavy-Duty Onroad Center

Assessment and Standards Division

Office of Transportation and Air Quality

US Environmental Protection Agency

2000 Traverwood Drive

Ann Arbor, MI 48105

(734) 214-4155

(734) 214-4050 (fax)

(734) 353-9623 (cell)

e-mail<EMAIL_ADDRESS> **********************************************************

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Gladys Bryant-Akers/DC/USEPA/US@EPA

Date:	08/17/2010 04:14 PM

Subject:	HD Fuel Economy and GHG Briefing

Hi Chandana,

I checked with Margo's office this afternoon, and they are confident that she would like to be part of our staff briefing on the Heavy-Duty package.  Could you please coordinate with Gladys Bryant-Akers (564-1682) to get the briefing onto Margo's calendar as well?

Thursday, August 26 remains the best date for the EPA staff in Ann Arbor.  Given Margo's interest in participating, we will travel for the meeting.  Hence, there is no need to coordinate a video call.

Thanks,

Byron

******************************************************************

Byron Bunker

Center Director - Heavy-Duty Onroad Center

Assessment and Standards Division

Office of Transportation and Air Quality

US Environmental Protection Agency

2000 Traverwood Drive

Ann Arbor, MI 48105

(734) 214-4155

(734) 214-4050 (fax)

(734) 353-9623 (cell)

e-mail<EMAIL_ADDRESS> **********************************************************

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> Date:	09/02/2010 10:13 AM

Subject:	Re: FW: Times for HD meeting

Hi Chandana,

Did you want to suggest a time this morning for us to talk or would you prefer that Jim and I call you whenever we can?    I believe Jim will be available around 10:30.

Thanks,

Byron

******************************************************************

Byron Bunker

Center Director - Heavy-Duty Onroad Center

Assessment and Standards Division

Office of Transportation and Air Quality

US Environmental Protection Agency

2000 Traverwood Drive

Ann Arbor, MI 48105

(734) 214-4155

(734) 214-4050 (fax)

(734) 353-9623 (cell)

e-mail<EMAIL_ADDRESS> **********************************************************

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS> Date:	09/02/2010 06:54 PM

Subject:	Re: Times for HD meeting

Hi Chandana,

From EPA we expect to have

Margo Oge

Chet France

Byron Bunker

Steve Silverman or John Hannon

Thanks,

Byron

******************************************************************

Byron Bunker

Center Director - Heavy-Duty Onroad Center

Assessment and Standards Division

Office of Transportation and Air Quality

US Environmental Protection Agency

2000 Traverwood Drive

Ann Arbor, MI 48105

(734) 214-4155

(734) 214-4050 (fax)

(734) 353-9623 (cell)

e-mail<EMAIL_ADDRESS> **********************************************************

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Date:	09/07/2010 12:33 PM

Subject:	Re: Times for HD meeting

Thanks Chandana.

I have an e-mail from Paul Balserak asking if there will be a call in number?

Thanks,

Byron

Sent by EPA Wireless E-Mail Services

----- Original Message -----

From: "Achanta, Chandana L."<EMAIL_ADDRESS> Sent: 09/07/2010 11:56 AM AST

To: Byron Bunker

Subject: RE: Times for HD meeting

We're good with the room now so meeting still in Wilson Room of WHCC.

-----Original Message-----

From<EMAIL_ADDRESS><EMAIL_ADDRESS>

Sent: Friday, September 03, 2010 3:34 PM

To<EMAIL_ADDRESS>Achanta, Chandana L.

Cc: james tamm<EMAIL_ADDRESS><EMAIL_ADDRESS> Subject: Re: Times for HD meeting

Yes.  Sorry I didn't think to send this to you and Paul yesterday.

Sent by EPA Wireless E-Mail Services

    ----- Original Message -----

    From: Ann Wolverton

    Sent: 09/03/2010 03:09 PM EDT

    To: Byron Bunker; "Achanta, Chandana L."

<EMAIL_ADDRESS>     Cc: "james tamm"<EMAIL_ADDRESS>Paul Balserak; Lori Stewart

    Subject: Re: Times for HD meeting

To confirm, this meeting is scheduled for Tuesday at 4 PM in the Wilson room of the WHCC - is that correct?

Ann

    ----- Original Message -----

    From: Byron Bunker

    Sent: 09/03/2010 02:57 PM EDT

    To: Byron Bunker; "Achanta, Chandana L."

<EMAIL_ADDRESS>     Cc: "james tamm"<EMAIL_ADDRESS>Paul Balserak; Ann Wolverton; Lori Stewart

    Subject: Re: Times for HD meeting

Hi Chandana,

I wasn't thinking yesterday, but we should assume that Paul Balserak and Ann Wolverton will join us as well.

Paul/Ann - please see the e-mail chain below for the time and place for the meeting.

I will get materials to everyone by Tues AM.

Thanks,

Byron

Sent by EPA Wireless E-Mail Services

    ----- Original Message -----

    From: Byron Bunker

    Sent: 09/02/2010 06:54 PM EDT

    To: "Achanta, Chandana L."<EMAIL_ADDRESS>     Cc<EMAIL_ADDRESS>     Subject: Re: Times for HD meeting

Hi Chandana,

From EPA we expect to have

Margo Oge

Chet France

Byron Bunker

Steve Silverman or John Hannon

Thanks,

Byron

******************************************************************

Byron Bunker

Center Director - Heavy-Duty Onroad Center Assessment and Standards Division Office of Transportation and Air Quality US Environmental Protection Agency 2000 Traverwood Drive Ann Arbor, MI 48105

(734) 214-4155

(734) 214-4050 (fax)

(734) 353-9623 (cell)

e-mail<EMAIL_ADDRESS> **********************************************************

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  |"Achanta, Chandana L."<EMAIL_ADDRESS>                                                                                |

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  |Gladys Bryant-Akers/DC/USEPA/US@EPA                                                                                |

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| Cc:        |

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  |Byron Bunker/AA/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>              |

<EMAIL_ADDRESS><EMAIL_ADDRESS>                                                                                |

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  |09/02/2010 04:58 PM                                                                                |

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  |Re: Times for HD meeting                                                                                |

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Wilson room of WHCC.

Please send just names by cob tomorrow.

----- Original Message -----

From<EMAIL_ADDRESS> <EMAIL_ADDRESS> To: Achanta, Chandana L.

Cc<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS> Sent: Thu Sep 02 11:48:11 2010

Subject: Re: Times for HD meeting

Hi Chandana

I understand from Byron that this meeting has been finalized.  The email below is the last I had heard on it.  Do we have a location yet?

Thanks.

Gladys

  From:       "Achanta, Chandana L."<EMAIL_ADDRESS>   To<EMAIL_ADDRESS><EMAIL_ADDRESS>Byron

Bunker/AA/USEPA/US@EPA, Gladys

              Bryant-Akers/DC/USEPA/US@EPA, <EMAIL_ADDRESS> <EMAIL_ADDRESS><EMAIL_ADDRESS> <EMAIL_ADDRESS>   Date:       08/30/2010 01:43 PM

  Subject:    Times for HD meeting

Lets aim for a meeting next week? Here are our available times:

Tuesday, Sept 7th: 4PM

Wed Sept 8th: anytime after 2PM

Sept 9th: 3:30PM.

Do any of those times work?

Thanks.

Chandana

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> Date:	09/08/2010 09:31 AM

Subject:	Re: Times for HD meeting

Margo meeting moved to 4:00.

11:00 works for me.

Thanks,

Byron

******************************************************************

Byron Bunker

Center Director - Heavy-Duty Onroad Center

Assessment and Standards Division

Office of Transportation and Air Quality

US Environmental Protection Agency

2000 Traverwood Drive

Ann Arbor, MI 48105

(734) 214-4155

(734) 214-4050 (fax)

(734) 353-9623 (cell)

e-mail<EMAIL_ADDRESS> **********************************************************

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> Date:	09/08/2010 09:34 AM

Subject:	Re: Times for HD meeting

10:45 is good or 11:00 is now good.

Sorry to make it complicated.  Let me know, I can do either.

Thanks,

Byron

******************************************************************

Byron Bunker

Center Director - Heavy-Duty Onroad Center

Assessment and Standards Division

Office of Transportation and Air Quality

US Environmental Protection Agency

2000 Traverwood Drive

Ann Arbor, MI 48105

(734) 214-4155

(734) 214-4050 (fax)

(734) 353-9623 (cell)

e-mail<EMAIL_ADDRESS> **********************************************************

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Angela Cullen/AA/USEPA/US@EPA

Date:	09/10/2010 04:14 PM

Subject:	Re: Missing sections of the HD trucks RIA

Hi Chandana,

The analysis is done, and we have circulated the updated drafts for a quick internal review.  You should receive them first thing next week.

Thanks,

Byron

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS> Date:	09/14/2010 04:33 PM

Subject:	Comments on HD?

Hi Chandana,

I was hoping to get the Heavy-Duty comments distributed yet today.  Do you know when you will be able to get them to us?

Thanks,

Byron

******************************************************************

Byron Bunker

Center Director - Heavy-Duty Onroad Center

Assessment and Standards Division

Office of Transportation and Air Quality

US Environmental Protection Agency

2000 Traverwood Drive

Ann Arbor, MI 48105

(734) 214-4155

(734) 214-4050 (fax)

(734) 353-9623 (cell)

e-mail<EMAIL_ADDRESS> **********************************************************

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc:	Ann Wolverton/DC/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Nicole Owens/DC/USEPA/US@EPA, Paul Balserak/DC/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS> Date:	09/21/2010 03:47 PM

Subject:	Re: Summary of interagency working comments received on draft rule under EO 12866 review

Hi Chandana,

Yes, we can be available at 4:30.  Will you set up a call-in number or should I?

Thanks,

Byron

******************************************************************

Byron Bunker

Center Director - Heavy-Duty Onroad Center

Assessment and Standards Division

Office of Transportation and Air Quality

US Environmental Protection Agency

2000 Traverwood Drive

Ann Arbor, MI 48105

(734) 214-4155

(734) 214-4050 (fax)

(734) 353-9623 (cell)

e-mail<EMAIL_ADDRESS> **********************************************************

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc:	Ann Wolverton/DC/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS>Nicole Owens/DC/USEPA/US@EPA, Paul Balserak/DC/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS><EMAIL_ADDRESS> Date:	09/21/2010 03:55 PM

Subject:	RE: Summary of interagency working comments received on draft rule under EO 12866 review

Hi Chandana,

Let's use the following call-in.

Conference Line:<PHONE_NUMBER>

Code:<PHONE_NUMBER>#

Thanks,

Byron

******************************************************************

Byron Bunker

Center Director - Heavy-Duty Onroad Center

Assessment and Standards Division

Office of Transportation and Air Quality

US Environmental Protection Agency

2000 Traverwood Drive

Ann Arbor, MI 48105

(734) 214-4155

(734) 214-4050 (fax)

(734) 353-9623 (cell)

e-mail<EMAIL_ADDRESS> **********************************************************

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc:	Ann Wolverton/DC/USEPA/US@EPA, James Tamm<EMAIL_ADDRESS>Paul Balserak/DC/USEPA/US@EPA

Date:	09/22/2010 02:34 PM

Subject:	RE: Next HD Meeting

Hi Chandana,

I am on a conference call with Jim.  That will work for NHTSA and EPA.

We can use the same call-in number from yesterday.<PHONE_NUMBER>   Code 7342144155#

Thanks,

Byron

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS>"Lee, Amanda I."<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS>Chet France/AA/USEPA/US@EPA, Kathryn Sargeant/AA/USEPA/US@EPA, William Charmley/AA/USEPA/US@EPA, Ken Davidson/DC/USEPA/US@EPA, Gloria Helfand/AA/USEPA/US@EPA, Angela Cullen/AA/USEPA/US@EPA, Donald Kopinski/AA/USEPA/US@EPA, Sharyn Lie/DC/USEPA/US@EPA

Date:	09/24/2010 05:32 AM

Subject:	Treatment of Fuel Savings

Hi Chandana,

I thought a more concrete example would be helpful in our discussion of accounting for fuel savings as a negative cost or a benefit.  Below are two tables with roughly accurate estimates of cost and benefits from the 2007 heavy-duty rule and our proposed HD fuel efficiency and GHG rules.   These are only a partial accounting for illustrative purposes and the numbers are based on very round estimates ($3/gal, 6mpg, 138 billion VMT, $6.5 B VSL,...)

I expressed the cost numbers in cents per mile because I think that is conceptually easier to follow.  I converted that to billions of dollars using VMT for the benefits column and the bottom totals.

I know that to you these seem like arbitrary accounting differences, but I find the construct of moving between costs and benefits dependent on your baseline or control  case confusing at best and quite possibly misleading.

When we did our 2007 rule the trucking industry cost to drive a mile was something on the order of $1 per mile.  Our fuel quality change increased that by about a penny and changes in maintenance practices (oil change interval) decreased that by about 0.2 cents.  Hence, EPA would say as a result of our rule that costs have gone up by about 0.8 cents per mile.  OMB would say costs went up by 1 cent per mile and there was a 0.2 cent benefit realized.

Now when it is time for this rule, what is my proper baseline?  I assume I should start with a cost of $1.008 per mile (the actual cost per mile for the industry).  Does OMB think I should start with a cost of $1.01 per mile?  I assume not.

This is the part I find so confusing.  A cost that is in my baseline becomes a private benefit in my control case and then goes back to being a cost in my base case for the next rule.

I think you can see why this would be a concern for EPA over time.  Often when we estimate the cost for changes to vehicles we add new components (e.g. an integrated starter generator) increasing cost and remove existing components (e.g. the alternator) reducing costs.  If we call the $500 increase for the integrated starter generator a cost and the $100 savings for removing the alternator a benefit, we end the rule with a $500 cost.  Obviously, the general public is going to assume EPA has estimated that costs for vehicles will go up $500 if we report that as our cost and bury the $100 alternator savings within the benefits.  This gets even more confusing over time since the average reader will certainly assume they can add up EPA cost estimates from multiple rules.  Of course, that approach does not work if cost savings are moved into the benefits column.

I am hoping that we can talk about this more at our call today.

Thanks - Byron

Current EPA Approach

Regulatory Impact	Cost Per Mile	EPA Rules Benefits

Remove Sulfur from diesel fuel increasing fuel costs 6 cents per gallon 1 cent Increase	-

Oil change interval increased because less acidification of engine oil from fuel sulfur	0.2 cent Decrease	-

Engine oil price increase due to more expense oil additives 	0.05 cent Increase	-

Fuel efficiency improvement due to Aerodynamic Fairing	2.2 cent Decrease -

Vehicle price increase due to purchase of Aerodynamic Fairing	.3 cent Increase	-

4,000 Fewer Premature Mortalities	-	$26 B

Total	1.05 Decrease ($1.5 B)	$26 B

Proposed OMB Approach

Regulatory Impact	Cost Per Mile	EPA Rules Benefits

Remove Sulfur from diesel fuel increasing fuel costs 6 cents per gallon 1 cent Increase	-

Oil change interval increased because less acidification of engine oil from fuel sulfur	 	$0.3 B

Engine oil price increase due to more expense oil additives 	0.05 cent Increase	-

Fuel efficiency improvement due to Aerodynamic Fairing	 	$3 B

Vehicle price increase due to purchase of Aerodynamic Fairing	.3 cent Increase	-

4,000 Fewer Premature Mortalities	-	$26 B

Total	1.35 Increase ($1.9 B)	$29.3 B

----- Forwarded by Byron Bunker/AA/USEPA/US on 10/26/2010 04:48 PM -----

From:	Byron Bunker/AA/USEPA/US

To:	"Achanta, Chandana L."<EMAIL_ADDRESS> Cc<EMAIL_ADDRESS><EMAIL_ADDRESS> Date:	09/24/2010 05:33 PM

Subject:	Re: sorry running over my 5PM call

Yes.  5:45 works.

From:	"Achanta, Chandana L."<EMAIL_ADDRESS> To:	Byron Bunker/AA/USEPA/US@EPA, <EMAIL_ADDRESS><EMAIL_ADDRESS> Date:	09/24/2010 05:32 PM

Subject:	sorry running over my 5PM call

Can we talk at 5:45? I will get off.


[Federal Register Volume 86, Number 189 (Monday, October 4, 2021)]
[Notices]
[Pages 54690-54691]
[FR Doc No: 2021-21478]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2021-0654; FRL-9095-01-OAR]

Clean Air Act Advisory Committee (CAAAC): Notice of Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of meeting.

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

SUMMARY: Pursuant to the Federal Advisory Committee Act (FACA), the
Environmental Protection Agency (EPA) is announcing a public meeting of
the Clean Air Act Advisory Committee (CAAAC) to be conducted via
remote/virtual participation only. The EPA renewed the CAAAC charter on
November 19, 2020 to provide independent advice and counsel to EPA on
economic, environmental, technical, scientific and enforcement policy
issues associated with implementation of the Clean Air Act of 1990.

DATES: The CAAAC will hold its next public meeting remotely/virtually
on Monday, October 18, 2021 from 1:00 p.m. to 4:00 p.m. (EST) and
Tuesday, October 19, 2021 from 1:00 p.m. to 4:00 p.m. (EST). Members of
the public may register to listen to the meeting or provide comments,
by emailing<EMAIL_ADDRESS>by 5:00 p.m. (EST) October 16, 2021.

FOR FURTHER INFORMATION CONTACT: Lorraine Reddick, Designated Federal
Official, Clean Air Act Advisory Committee (6103A), Environmental
Protection Agency, 1200 Pennsylvania Ave. NW, Washington, DC 20460;
telephone number:<PHONE_NUMBER>; email address:
<EMAIL_ADDRESS>Additional information about this meeting,
the CAAAC, and its subcommittees and workgroups can be found on the
CAAAC website: http://www.epa.gov/oar/caaac/.

SUPPLEMENTARY INFORMATION: Pursuant to 5 U.S.C. App. 2 section
10(a)(2), notice is hereby given that the Clean Air Act Advisory
Committee will hold its next public meeting remotely/virtually on
Monday, October 18, 2021 from 1:00 p.m. to 4:00 p.m. and Tuesday,
October 19, 2021 from 1:00 p.m. to 4:00 p.m. (EST).
    The committee agenda and any documents prepared for the meeting
will be publicly available on the CAAAC website at http://www.epa.gov/caaac/ prior to the meeting. Thereafter, these documents, together with
CAAAC meeting minutes, will be available on the CAAAC website or by
contacting the Office of Air and Radiation Docket and requesting
information under docket

EPA-HQ-OAR-2021-0654. The docket office can be reached by email at<EMAIL_ADDRESS>or FAX:<PHONE_NUMBER>.
    For information on access or services for individuals with
disabilities, please contact Lorraine Reddick at
<EMAIL_ADDRESS>preferably at least 7 days prior to the
meeting to give EPA as much time as possible to process your request.

    Dated: September 28, 2021.
Jonathan Lubetsky,
Group Leader, Office of Air Policy and Program Support, Environmental
Protection Agency.
[FR Doc. 2021-21478 Filed 10-1-21; 8:45 am]
BILLING CODE 6560-50-P


10/21/2015................................  GPRO........................            0.16            1.23            0.13            1.10           1,636
10/21/2015................................  HYG.........................            0.18            1.49            0.12            0.80           1,748
10/21/2015................................  OIH.........................            0.09            0.86            0.06            0.75           2,753
10/21/2015................................  RAD.........................            0.13            0.31            0.11            0.30           4,003
10/21/2015................................  RSX.........................            0.12            0.53            0.08            0.45           2,522
10/28/2015................................  BABA........................            0.08            0.66            0.05            0.45             987
10/28/2015................................  CBS.........................            0.20            0.99            0.18            0.70           1,044
10/28/2015................................  FEYE........................            0.18            0.84            0.16            0.65           1,479
10/28/2015................................  GPRO........................            0.15            0.97            0.09            0.80           1,574
10/28/2015................................  HYG.........................            0.17            2.47            0.10            2.70           1,665
10/28/2015................................  OIH.........................            0.13            1.30            0.08            1.10           3,245
10/28/2015................................  RAD.........................            0.18            3.56            0.04            4.33           1,411
10/28/2015................................  RSX.........................            0.17            0.72            0.12            0.70           2,396
11/4/2015.................................  BABA........................            0.06            0.50            0.04            0.35             784
11/4/2015.................................  CBS.........................            0.30            1.89            0.24            1.80           1,260
11/4/2015.................................  FEYE........................            0.17            0.89            0.16            0.65           2,112
11/4/2015.................................  GPRO........................            0.15            0.93            0.12            0.80           1,899
11/4/2015.................................  HYG.........................            0.16            2.49            0.09            2.60           1,485
11/4/2015.................................  OIH.........................            0.13            0.99            0.08            0.85           2,960
11/4/2015.................................  RAD.........................            0.33            1.27            0.25            0.55           1,996
11/4/2015.................................  RSX.........................            0.16            0.86            0.10            0.75           2,401
11/11/2015................................  BABA........................            0.07            0.56            0.05            0.35             304
11/11/2015................................  CBS.........................            0.20            1.27            0.16            0.95           1,264
11/11/2015................................  FEYE........................            0.17            1.19            0.14            0.95           1,705
11/11/2015................................  GPRO........................            0.15            0.87            0.13            0.75           1,264
11/11/2015................................  HYG.........................            0.18            2.13            0.08            1.60           1,308
11/11/2015................................  OIH.........................            0.12            1.04            0.08            0.90           2,824
11/11/2015................................  RAD.........................            0.47            2.88            0.16            3.35           1,837
11/11/2015................................  RSX.........................            0.14            0.60            0.09            0.55           1,897
11/18/2015................................  BABA........................            0.05            0.44            0.03            0.30             861
11/18/2015................................  CBS.........................            0.22            1.33            0.17            1.05           1,467

11/18/2015................................  FEYE........................            0.18            0.99            0.16            0.95           2,330
11/18/2015................................  GPRO........................            0.19            1.47            0.12            1.40           1,893
11/18/2015................................  HYG.........................            0.19            2.49            0.10            2.65           2,772
11/18/2015................................  OIH.........................            0.12            1.10            0.07            0.95           2,420
11/18/2015................................  RAD.........................            0.45            3.24            0.14            4.50           1,960
11/18/2015................................  RSX.........................            0.15            0.58            0.11            0.50           1,631
11/25/2015................................  BABA........................            0.05            0.39            0.04            0.30             859
11/25/2015................................  CBS.........................            0.25            1.39            0.22            0.90           1,064
11/25/2015................................  FEYE........................            0.18            1.02            0.15            0.80           1,691
11/25/2015................................  GPRO........................            0.20            1.08            0.14            0.95           1,769
11/25/2015................................  HYG.........................            0.21            2.71            0.13            2.70           1,291
11/25/2015................................  OIH.........................            0.09            1.15            0.06            1.00           1,572
11/25/2015................................  RAD.........................            0.34            3.27            0.16            4.45           1,320
11/25/2015................................  RSX.........................            0.13            0.72            0.08            0.55           1,667
12/2/2015.................................  BABA........................            0.06            0.51            0.04            0.30             567
12/2/2015.................................  CBS.........................            0.22            1.47            0.16            1.15           1,201
12/2/2015.................................  FEYE........................            0.12            1.01            0.08            0.70           1,754
12/2/2015.................................  GPRO........................            0.16            0.81            0.11            0.65           1,298
12/2/2015.................................  HYG.........................            0.19            1.79            0.11            1.25           1,484
12/2/2015.................................  OIH.........................            0.09            1.17            0.05            1.05           1,497
12/2/2015.................................  RAD.........................            0.51            3.03            0.15            3.25           1,293
12/2/2015.................................  RSX.........................            0.13            0.62            0.08            0.50           1,940
12/9/2015.................................  BABA........................            0.06            0.48            0.04            0.35             503
12/9/2015.................................  CBS.........................            0.23            1.25            0.19            1.10             973
12/9/2015.................................  FEYE........................            0.12            1.02            0.06            0.90           1,013
12/9/2015.................................  GPRO........................            0.09            1.03            0.05            0.90             693
12/9/2015.................................  HYG.........................            0.17            2.18            0.10            1.70             989
12/9/2015.................................  OIH.........................            0.10            1.46            0.05            1.35           2,167
12/9/2015.................................  RAD.........................            0.31            3.75            0.14            4.55             853
12/9/2015.................................  RSX.........................            0.14            0.80            0.09            0.60           1,853
12/16/2015................................  BABA........................            0.12            0.77            0.06            0.50             705
12/16/2015................................  CBS.........................            0.30            1.79            0.28            1.50           1,250
12/16/2015................................  FEYE........................            0.21            1.24            0.15            0.90           1,731
12/16/2015................................  GPRO........................            0.18            1.16            0.11            1.00             947
12/16/2015................................  HYG.........................            0.22            2.68            0.19            3.15           1,539
12/16/2015................................  OIH.........................            0.15            1.64            0.07            1.20           2,458
12/16/2015................................  RAD.........................            0.43            4.41            0.18            4.65             974
12/16/2015................................  RSX.........................            0.20            1.87            0.10            1.00           2,407
12/23/2015................................  BABA........................            0.11            0.66            0.05            0.45             663
12/23/2015................................  CBS.........................            0.28            1.71            0.24            1.15             568
12/23/2015................................  FEYE........................            0.20            1.30            0.17            1.15             949
12/23/2015................................  GPRO........................            0.22            0.97            0.13            0.80           1,306
12/23/2015................................  HYG.........................            0.21            3.14            0.16            3.70           2,071
12/23/2015................................  OIH.........................            0.11            1.30            0.05            0.90           3,149
12/23/2015................................  RAD.........................            0.35            4.08            0.17            4.50           1,271
12/23/2015................................  RSX.........................            0.16            1.24            0.08            0.80           1,892
12/30/2015................................  BABA........................            0.16            0.62            0.06            0.45             787
12/30/2015................................  CBS.........................            0.19            1.61            0.19            1.10             772
12/30/2015................................  FEYE........................            0.21            1.08            0.19            0.85           1,059
12/30/2015................................  GPRO........................            0.22            0.98            0.16            0.80           1,295
12/30/2015................................  HYG.........................            0.20            1.86            0.13            1.35           2,193
12/30/2015................................  OIH.........................            0.11            1.65            0.06            1.15           3,080
12/30/2015................................  RAD.........................            0.55            4.00            0.19            4.50           1,132
12/30/2015................................  RSX.........................            0.15            1.85            0.10            0.90           2,120
--------------------------------------------------------------------------------------------------------------------------------------------------------

Exhibit B to Amendment No. 5

AMENDMENT TO PLAN FOR THE PURPOSE OF DEVELOPING AND IMPLEMENTING
PROCEDURES DESIGNED TO FACILITATE THE LISTING AND TRADING OF
STANDARDIZED OPTIONS SUBMITTED PURSUANT TO SECTION 11A(a)(3)(B)OF THE
SECURITIES EXCHANGE ACT OF 1934.

    Italicized language indicates additions. [Bracketed] language
indicates deletions.

PLAN FOR THE PURPOSE OF DEVELOPING AND IMPLEMENTING PROCEDURES DESIGNED
TO FACILITATE THE LISTING AND TRADING OF STANDARDIZED OPTIONS SUBMITTED
PURSUANT TO SECTION 11A(a)(3)(B) OF THE SECURITIES EXCHANGE ACT OF 1934

* * * * *
3.1 Selecting Option Classes for the Penny Interval Program (``Penny
Program'')
    The registered options exchanges agree to list option classes for
the Penny Program with the following minimum increment quoting
requirements (``penny increments''):
    (A) one cent ($0.01) for all series in QQQ (PowerShares QQQ
TrustSM, Series 1), SPY (SPDR S&P 500 ETF) and IWM (iShares Russell
2000 Index Fund), regardless of price;
    (B) one cent ($0.01) for all series in such option classes included
in the Penny Program with a price of less than $3.00;
    (C) five cents ($0.05) for all series in such option classes
included in the Penny Program with a price of $3.00 or higher.
    (a) Initial Selection. On the first trading day of the third full
calendar month after [insert date of approval], the Penny Program will
apply only to the 363 most actively traded multiply listed option
classes, based on OCC's National Cleared Volume in the six full
calendar months ending in the month of approval, that (i) currently
quote in penny increments, or (ii) overlie securities priced below
$200, or any index at an index level below $200. Eligibility for
inclusion in the Penny Program will be determined at the close of
trading on the monthly Expiration Friday of the second full month
following [insert date of approval].
    (b) Annual Review. Commencing in December 2020 and each December
thereafter, OCC will rank all multiply listed option classes based on
National Cleared Volume for the six full calendar months from June 1
through November 30 for determination of the most actively traded
option classes.
    (1) Addition to the Penny Program. Based on the Annual Review, any
option class not in the Penny Program that is among the 300 most
actively traded multiply listed option classes overlying securities
priced below $200, or an index at an index level below $200, will be
added to the Penny Program on the first trading day of January.
    (2) Removal from the Penny Program. Except as provided in (c), (d),
(e) and (f) below, based on the Annual Review, any option class in the
Penny Program that falls outside the 425 most actively traded multiply
listed option classes will be removed from the Penny Program on the
first trading day of April.
    (c) Newly Listed Option Classes. A registered options exchange may
add a newly listed option class to the Penny Program, provided that (i)
it is among the 300 most actively traded multiply listed option
classes, as ranked by National Cleared Volume at OCC, in its first full
calendar month of trading and (ii) the underlying security is priced
below $200 or the underlying index is at an index level below $200. Any
option class added under this provision will be added on the first
trading day of the month after it qualifies and will remain in the
Penny Program for one full calendar year, after which it will be
subject to the Annual Review stated in section (b) above.
    (d) Classes with Significant Growth in Activity. A registered
options exchange may add any option class to the Penny Program,
provided that (i) it is among the 75 most actively traded multiply
listed option classes, as ranked by National Cleared Volume at OCC, in
the past six full calendar months of trading and (ii) the underlying
security is priced below $200 or the underlying index is at an index
level below $200. Any option class added under this provision will be
added on the first trading day of the second full month after it
qualifies and will remain in the Penny Program for the rest of the
calendar year, after which it will be subject to the Annual Review
stated in section (b) above.
    (e) Corporate Actions. If a corporate action involves one or more
option classes in the Penny Program, all adjusted and unadjusted series
of the option class will be included in the Penny Program. Any new
option class added to the Penny Program under this provision will
remain in the Penny Program for one full calendar year; after which it
will be subject to the Annual Review stated in section (b) above.
    (f) Delisted or Ineligible Option Classes. Any series in an option
class participating in the Penny Program in which the underlying
security has been delisted, or are identified by OCC as ineligible for
opening customer transactions, will continue to quote pursuant to the
terms of the Penny Program until all such options have expired.
    (g) The registered options exchanges agree that references to
multiply listed option classes in this section of the Plan only applies
to option classes in the Penny Program, and to no other sections of the
Plan.
    (h) Not sooner than 60 months after approval of the Penny Program,
a super-majority (\2/3\) of the Plan Sponsors may vote to make changes
to the Penny Program. At any time before 60 months have passed since
the adoption of the Penny Program, any changes must be unanimously
approved by the Plan Sponsors. Any changes to the Penny Program are
subject to SEC review pursuant to Section 11A(a)(3) of the Securities
Exchange Act of 1934 and Rule 608 thereunder.
    4. Adjustments Pursuant to OCC By-Laws--Article VI, Section 11 of
the OCC By-Laws, as approved by the SEC, provides that [an adjustment
panel of the Securities Committee, comprised of representatives from
each registered options exchange trading options on the affected
underlying security,]OCC shall determine whether to make adjustments to
reflect particular events in respect of such underlying security, and
the nature and extent of any such adjustment. In connection with such
determinations, the options exchanges trading such options class are
authorized to determine operational issues attendant to the adjustment
made by [the adjustment panel]OCC.
* * * * *
    9. List of Plan Sponsors--The Sponsors of the Options Listing
Procedures Plan are as follows:
     [American Stock Exchange LLC (``AMEX'')]NYSE American,
LLC, registered as a national securities exchange under the Exchange
Act and having its principal place of business at [86 Trinity Place,
New York, New York 10006]11 Wall Street, New York, NY 10005.
     [BATS Exchange, Inc. (``BATS'')]Cboe BZX Exchange, Inc.,
registered as a national securities exchange under the Exchange Act and
having its principal place of business at [8050 Marshall Dr., Suite
120, Lenexa, Kansas 66214]400 South LaSalle Street, Chicago, Illinois
60605.
     BOX [Options] Exchange LLC (``BOX''), registered as a
national

securities exchange under the Exchange Act and having its principal
place of business at 101 Arch Street, St. 610, Boston, Massachusetts
02110.
     [Chicago Board Options Exchange, Incorporated.
(``CBOE'')]Cboe Exchange, Inc., registered as a national securities
exchange under the Exchange Act and having its principal place of
business at 400 South LaSalle Street, Chicago, Illinois 60605.
     [C2 Options Exchange, Incorporated (``C2'')]Cboe C2
Exchange, Inc., registered as a national securities exchange under the
Exchange Act and having its principal place of business at 400 South
LaSalle Street, Chicago, Illinois 60605.
     [EDGX Exchange, Inc. (``EDGX'')]Cboe EDGX Exchange, Inc.,
registered as a national securities exchange under the Exchange Act and
having its principal place of business at [8050 Marshall Dr., Suite
120, Lenexa, Kansas 66214]400 South LaSalle Street, Chicago, Illinois
60605.
     [International Securities Exchange LLC (``ISE'')]Nasdaq
ISE, LLC, registered as a national securities exchange under the
Exchange Act and having its principal place of business at [60 Broad
Street, New York, New York 10004]One Liberty Plaza, 50th Floor, New
York, New York 10006.
     [ISE Mercury, LLC (``ISE Mercury'')]Nasdaq MRX, LLC,
registered as a national securities exchange under the Exchange Act and
having its principal place of business at [60 Broad Street, New York,
New York 10004]One Liberty Plaza, 50th Floor, New York, New York 10006.
     Miami International Securities Exchange, LLC (``MIAX''),
registered as a national securities exchange under the Exchange Act and
having its principal place of business at 7 Roszel Road, Fifth Floor,
Princeton, New Jersey 08540.
     MIAX Emerald, LLC (``MIAX Emerald''), registered as a
national securities exchange under the Exchange Act and having its
principal place of business at 7 Roszel Road, Fifth Floor, Princeton,
New Jersey 08540.
     MIAX PEARL, LLC (``MIAX PEARL''), registered as a national
securities exchange under the Exchange Act and having its principal
place of business at 7 Roszel Road, Fifth Floor, Princeton, New Jersey
08540.
     The [NASDAQ]Nasdaq Stock Market LLC, registered as a
national securities exchange under the Exchange Act and having its
principal place of business at One Liberty Plaza, 50th Floor, New York,
New York 10006.
     [NASDAQ OMX BX, Inc., (``BX'')]Nasdaq BX, Inc., registered
as a national securities exchange under the Exchange Act and having its
principal place of business at One Liberty Plaza, 50th Floor, New York,
New York 10006.
     The Options Clearing Corporation (``OCC''), registered as
a clearing agency under the Exchange Act and having its principal place
of business at [440 South LaSalle Street, Chicago, Illinois 60605]125
South Franklin Street, Suite 1200, Chicago, Illinois 60606.
     [Pacific Exchange, Inc. (``PCX'')]NYSE Arca, Inc.,
registered as a national securities exchange under the Exchange Act and
having its principal place of business at [301 Pine Street, San
Francisco, California 94104]11 Wall Street, New York, NY 10005.
     [Philadelphia Stock Exchange, Inc. (``PHLX'')]Nasdaq PHLX
LLC, registered as a national securities exchange under the Exchange
Act and having its principal place of business at [1900 Market Street,
Philadelphia, Pennsylvania 19103]FMC Tower, Level 8, 2929 Walnut
Street, Philadelphia, Pennsylvania 19104.
     [Topaz Exchange, LLC (``Topaz'')]Nasdaq GEMX, LLC,
registered as a national securities exchange under the Exchange Act and
having its principal place of business at [60 Broad Street, New York,
New York 10004]One Liberty Plaza, 50th Floor, New York, New York 10006.
* * * * *
[FR Doc. 2019-26816 Filed 12-16-19; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 86, Number 142 (Wednesday, July 28, 2021)]
[Notices]
[Pages 40567-40571]
[FR Doc No: 2021-16084]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0708]

Biosimilar User Fee Rates for Fiscal Year 2022

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the
rates for biosimilar user fees for fiscal year (FY) 2022. The Federal
Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Biosimilar
User Fee Amendments of 2017 (BsUFA II), authorizes FDA to assess and
collect user fees for certain activities in connection with biosimilar
biological product development; review of certain applications for
approval of biosimilar biological products; and each biosimilar
biological product approved in a biosimilar biological product
application. BsUFA II directs FDA to establish, before the beginning of
each fiscal year, the amount of initial and annual biosimilar
biological product development (BPD) fees, the reactivation fee, and
the biosimilar biological product application and program fees for such
year. These fees apply to the period from October 1, 2021, through
September 30, 2022.

FOR FURTHER INFORMATION CONTACT: Melissa Hurley, Office of Financial
Management, Food and Drug Administration, 4041 Powder Mill Rd., Rm.
61075, Beltsville, MD 20705-4304,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744G, 744H, and 744I of the FD&C Act (21 U.S.C. 379j-51,
379j-52, and 379j-53), as amended by BsUFA II (title IV of the FDA
Reauthorization Act of 2017, Pub. L. 115-52), authorize the collection
of fees for biosimilar biological products. Under section 744H(a)(1)(A)
of the FD&C Act, the initial BPD fee for a product is due when the
sponsor submits an investigational new drug (IND) application that FDA
determines is intended to support a biosimilar biological product
application or within 5 calendar days after FDA grants the first BPD
meeting, whichever occurs first. A sponsor who has paid the initial BPD
fee is considered to be participating in FDA's BPD program for that
product.
    Under section 744H(a)(1)(B) of the FD&C Act, once a sponsor has
paid the initial BPD fee for a product, the annual BPD fee is assessed
beginning with the next fiscal year. The annual BPD fee is assessed for
the product each fiscal year until the sponsor submits a marketing
application for the product that is accepted for filing or the sponsor
discontinues participation in FDA's BPD program for the product.
    Under section 744H(a)(1)(D) of the FD&C Act, if a sponsor has
discontinued participation in FDA's BPD program and wants to reengage
with FDA on development of the product, the sponsor must pay a
reactivation fee to resume participation in the program. The sponsor
must pay the reactivation fee by the earlier of the following dates: No
later than 5 calendar days after FDA grants the sponsor's request for a
BPD meeting for that product or upon the date of submission by the
sponsor of an IND describing an investigation that FDA determines is
intended to support a biosimilar biological product application for
that product. The sponsor will be assessed an annual BPD fee beginning
with the first fiscal year after payment of the reactivation fee.
    BsUFA II also authorizes fees for certain biosimilar biological
product

applications and for each biosimilar biological product identified in
an approved biosimilar biological product application (section
744H(a)(2) and (3) of the FD&C Act). Under certain conditions, FDA will
grant a small business a waiver from its first biosimilar biological
product application fee (section 744H(d)(1) of the FD&C Act).
    For FY 2018 through FY 2022, the base revenue amounts for the total
revenues from all BsUFA fees are established by BsUFA II. For FY 2022,
the base revenue amount is the FY 2021 inflation-adjusted fee revenue
amount of $42,493,066. The FY 2022 base revenue amount is to be
adjusted for inflation and to reflect changes in the resource capacity
needs for the process for the review of biosimilar biological product
applications. Additionally, it may be reduced, as appropriate, for
long-term financial planning purposes.
    This document provides fee rates for FY 2022 for the initial and
annual BPD fee ($57,184), for the reactivation fee ($114,368), for an
application requiring clinical data ($1,746,745), for an application
not requiring clinical data ($873,373), and for the program fee
($304,162). These fees are effective on October 1, 2021, and will
remain in effect through September 30, 2022. For applications that are
submitted on or after October 1, 2021, the new fee schedule must be
used.

II. Fee Revenue Amount for FY 2022

    The base revenue amount for FY 2022 is $42,493,066 prior to
adjustments for inflation, resource capacity, and operating reserves
(see section 744H(c)(1) through (3) of the FD&C Act).

A. FY 2022 Statutory Fee Revenue Adjustments for Inflation

    BsUFA II specifies that the $42,493,066 is to be adjusted for
inflation increases for FY 2022 using two separate adjustments--one for
personnel compensation and benefits (PC&B) and one for non-PC&B costs
(see section 744H(c)(1) of the FD&C Act).
    The component of the inflation adjustment for payroll costs shall
be one plus the average annual percent change in the cost of all PC&B
paid per full-time equivalent (FTE) positions at FDA for the first 3 of
the preceding 4 fiscal years, multiplied by the proportion of PC&B
costs to total FDA costs of the process for the review of biosimilar
biological product applications for the first 3 of the preceding 4
fiscal years (see section 744H(c)(1)(B) of the FD&C Act).
    Table 1 summarizes the actual cost and FTE data for the specified
fiscal years and provides the percent changes from the previous fiscal
years and the average percent changes over the first 3 of the 4 fiscal
years preceding FY 2022. The 3-year average is 2.7383 percent.

                                 Table 1--FDA PC&B Each Year and Percent Changes
----------------------------------------------------------------------------------------------------------------
               Fiscal year                      2018              2019              2020         3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..............................    $2,690,678,000    $2,620,052,000    $2,875,592,000  ................
Total FTE...............................            17,023            17,144            17,535  ................
PC&B per FTE............................          $158,061          $152,826          $163,992  ................
Percent Change From Previous Year.......           4.2206%          -3.3120%           7.3063%           2.7383%
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 2.7383 percent be multiplied by the
proportion of PC&B costs to the total FDA costs of the process for the
review of biosimilar biological product applications. Table 2 shows the
PC&B and the total obligations for the process for the review of
biosimilar biological product applications for the first 3 of the
preceding 4 fiscal years.

     Table 2--PC&B as a Percent of Total Cost of the Process for the Review of Biosimilar Biological Product
                                                  Applications
----------------------------------------------------------------------------------------------------------------
               Fiscal year                      2018              2019              2020         3-Year average
----------------------------------------------------------------------------------------------------------------
Total PC&B..............................       $35,477,032       $32,946,252       $25,445,175  ................
Total Costs.............................       $62,604,122       $65,210,467       $56,798,694  ................
PC&B Percent............................          56.6688%          50.5230%          44.7989%          50.6636%
----------------------------------------------------------------------------------------------------------------

    The payroll adjustment is 2.7383 percent from table 1 multiplied by
50.6636 percent (or 1.3873 percent).
    The statute specifies that the portion of the inflation adjustment
for nonpayroll costs is the average annual percent change that occurred
in the Consumer Price Index (CPI) for urban consumers (Washington-
Baltimore, DC-MD-VA-WV; not seasonally adjusted; all items; annual
index) for the first 3 years of the preceding 4 years of available data
multiplied by the proportion of all costs other than PC&B costs to
total costs of the process for the review of biosimilar biological
product applications for the first 3 years of the preceding 4 fiscal
years (see section 744H(c)(1)(B) of the FD&C Act). As a result of a
geographical revision made by the Bureau of Labor and Statistics in
January 2018,\1\ the Washington-Baltimore, DC-MD-VA-WV index was
discontinued and replaced with two separate indices (i.e., Washington-
Arlington-Alexandria, DC-VA-MD-WV and Baltimore-Columbia-Towson, MD).
In order to continue applying a CPI which best reflects the geographic
region in which FDA is headquartered and which provides the most
current data available, the Washington-Arlington-Alexandria index will
be used in calculating the relevant adjustment factors for FY 2020 and
subsequent years. Table 3 provides the summary data for the percent
changes in the specified CPI for the Washington-Arlington-Alexandria
area. The data are published by the Bureau of Labor Statistics and can
be found on its website at: https://data.bls.gov/pdq/SurveyOutputServlet?data_tool=dropmap&series_id=CUURS35ASA0,CUUSS35ASA0.

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

    \1\ The Bureau of Labor Statistics' announcement of the
geographical revision can be viewed at https://www.bls.gov/cpi/additional-resources/geographic-revision-2018.htm.

      Table 3--Annual and Three-Year Average Percent Change in CPI for Washington-Arlington-Alexandria Area
----------------------------------------------------------------------------------------------------------------
                      Year                             2018            2019            2020       3-Year average
----------------------------------------------------------------------------------------------------------------
Annual CPI......................................         261.445         264.777         267.157  ..............
Annual Percent Change...........................         2.0389%         1.2745%         0.8989%         1.4041%
----------------------------------------------------------------------------------------------------------------

    The statute specifies that this 1.4041 percent be multiplied by the
proportion of all costs other than PC&B to total costs of the process
for the review of biosimilar biological product applications obligated.
Since 50.6636 percent was obligated for PC&B (as shown in table 2),
49.3364 percent is the portion of costs other than PC&B (100 percent
minus 50.6636 percent equals 49.3364 percent). The nonpayroll
adjustment is 1.4041 percent times 49.3364 percent, 0.6927 percent.
    Next, we add the payroll adjustment (1.3873 percent) to the
nonpayroll adjustment (0.6927 percent), for a total inflation
adjustment of 2.0800 percent (rounded) for FY 2022.
    We then multiply the base revenue amount for FY 2022 ($42,493,066)
by one plus the inflation adjustment (1.0208), yielding an inflation-
adjusted amount of $43,376,922.

B. FY 2022 Statutory Fee Revenue Adjustments for Capacity Planning

    The statute specifies a process to establish and implement a
capacity planning adjustment (CPA) to adjust the total revenue amount
to reflect changes in the resource capacity needs for the process for
the review of biosimilar biological product applications (see section
744H(c)(2) of the FD&C Act). Following a process required in statute,
FDA established the capacity planning adjustment methodology and first
applied it in the setting of FY 2021 fees. The establishment of this
new methodology is described in the Federal Register at 85 FR 47220.
    The CPA methodology consists of four steps:
    1. Forecast workload volumes: predictive models estimate the volume
of workload for the upcoming fiscal year.
    2. Forecast the resource needs: Forecast algorithms are generated
utilizing time reporting data. These algorithms estimate the required
demand in FTEs \2\ for direct review-related effort. This is then
compared to current available resources for the direct review-related
workload.
---------------------------------------------------------------------------

    \2\ Full-time equivalents refers to a paid staff year, rather
than a count of individual employees.
---------------------------------------------------------------------------

    3. Assess the resource forecast in the context of additional
internal factors: Program leadership examines operational, financial,
and resourcing data to assess whether the FDA will be able to utilize
additional funds during the fiscal year and the funds are required to
support additional review capacity. FTE amounts are adjusted, if
needed.
    4. Convert the FTE need to dollars: utilizing the FDA's fully
loaded FTE cost model, the final feasible FTEs are converted to an
equivalent dollar amount.
    The following section outlines the major components of the FY 2022
BsUFA CPA. Table 4 summarizes the forecasted workload volumes for BsUFA
in FY 2022 based on predictive models, as well as historical actuals
from FY 2020 for comparison.

   Table 4--BsUFA Actual FY 2020 Workload Volumes & Predicted FY 2022
                            Workload Volumes
------------------------------------------------------------------------
                                              FY 2020         FY 2022
            Workload category                 actuals       predictions
------------------------------------------------------------------------
Supplements with Clinical Data..........               2               4
Labeling Supplements....................               4               8
Manufacturing Supplements...............              79             111
Biosimilar Biological Product                          7               7
 Applications...........................
BsUFA Industry Meetings (BIA, BPD Type 1-             95             120
 4).....................................
Participating BPD Programs..............             104             131
------------------------------------------------------------------------

    Utilizing the resource forecast algorithms, the forecasted workload
volumes for FY 2022 were then converted into estimated FTE needs for
FDA's BsUFA direct review-related work. The resulting expected FY 2022
FTE need for BsUFA was compared to current onboard capacity for BsUFA
direct review-related work to determine the FY 2022 resource delta, as
summarized in table 5.

                  Table 5--FY 2022 BsUFA Resource Delta
------------------------------------------------------------------------
   Current  resource        FY 2022  resource       Predicted  FY 2022
        capacity                 forecast                FTE delta
------------------------------------------------------------------------
               54                       71                      17
------------------------------------------------------------------------

    The projected 17 FTE delta was then assessed by FDA in the context
of additional operational and internal factors to ensure that a fee
adjustment is only made for resources which can be utilized in the
fiscal year and for which funds are required to support additional
review capacity. FDA determined that the expected net FTE gains could
be funded through the expected FY 2022 collections amount without a
further adjustment from the CPA. In summary, after accounting for these
internal factors, FDA determined that in FY 2022 the BsUFA fee amounts
did not need adjustment from the CPA to provide funds for the realistic
estimated net FTE gains.

                       Table 6--FY 2022 BsUFA CPA
------------------------------------------------------------------------
                                                Cost for
                                                  each         FY 2022
        Additional  FTEs for  FY 2022          additional     BsUFA CPA
                                                   FTE
------------------------------------------------------------------------
0...........................................     $312,185            $0
------------------------------------------------------------------------

    Although an adjustment to the fee amounts for resource needs by the
CPA will not be made in FY 2022, FDA will evaluate the need for a fee
adjustment from the CPA in future fiscal years and will make
adjustments as warranted.

C. FY 2022 Statutory Fee Revenue Adjustments for Operating Reserve

    BsUFA II provides for an operating reserve adjustment to allow FDA
to adjust the fee revenue and fees for any given fiscal year during
BsUFA II, after FY 2018, to maintain an appropriate operating reserve
of carryover user fees. Beginning in FY 2019, FDA may reduce the fee
revenue and fees for long-term financial planning purposes. Once the
capacity planning adjustment is effective, FDA also may, if necessary,
increase the fee revenue and fees to maintain not more than 21 weeks of
operating reserve of carryover user fees.
    As described in the BsUFA II commitment letter, Biosimilar
Biological Product Reauthorization Goals and Procedures Fiscal Years
2018 Through 2022,\3\ FDA is committed to reducing the BsUFA carryover
reserve to an amount no greater than 21 weeks of operating reserve of
carryover user fees by the end of FY 2022. Based on estimates published
in the FY 2021 update to the BsUFA II Five-Year Financial Plan, FDA
currently shows an operating reserve amount that currently exceeds the
committed amount. As such, FDA is applying a downward operating reserve
adjustment of $3,336,686 (rounded to the nearest dollar), an amount
equivalent to 4 weeks of operations. With this operating reserve
adjustment, the inflation-adjusted amount, $43,376,922, will be lowered
by $3,336,686, yielding the FY 2022 target revenue amount of
$40,040,000 (rounded to the nearest thousand).
---------------------------------------------------------------------------

    \3\ See: https://www.fda.gov/media/100573/download.
---------------------------------------------------------------------------

III. Fee Amounts for FY 2022

    Under section 744H(b)(3)(A) of the FD&C Act, FDA must determine the
percentage of the total revenue amount for a fiscal year to be derived
from: (1) Initial and annual BPD fees and reactivation fees; (2)
biosimilar biological product application fees; and (3) biosimilar
biological product program fees. In establishing the fee amounts for
the final year of BsUFA II, FDA considered how best to balance the fee
allocation to provide stable funding and reasonable fee amounts.

A. Application Fees

    In establishing the biosimilar biological product application fee
amount for FY 2022, FDA utilized an average of the 3 most recently
completed fiscal years (i.e., FY 2018-2020) of biosimilar biological
product application submissions. Based on the available information,
FDA estimates it will receive 7 biosimilar biological product
applications requiring clinical data for approval in FY 2022.
    FDA will maintain the biosimilar biological product application fee
for FY 2022 at the same level as FY 2021, which is $1,746,745. This is
estimated to provide a total of $12,227,215 representing 31 percent
(rounded to the nearest whole number) of the FY 2022 target revenue
amount.

B. Biosimilar Biological Product Program Fee

    Under BsUFA II, FDA assesses biosimilar biological product program
fees (``program fees''). An applicant in a biosimilar biological
product application shall not be assessed more than five program fees
for a fiscal year for biosimilar biological products identified in a
single biosimilar biological product application (see section
744H(a)(3)(D) of the FD&C Act). Applicants are assessed a program fee
for a fiscal year only for biosimilar biological products identified in
a biosimilar biological product application approved as of October 1 of
such fiscal year.
    Based on available information, FDA estimates that 67 program fees
will be invoiced for FY 2022, including currently approved products and
products with the potential to be approved in pending applications with
goal dates in FY 2021. For products invoiced in the FY 2022 regular
billing cycle, FDA anticipates that zero program fees will be refunded.
    FDA will maintain the biosimilar biological product program fee for
FY 2022 at the same level as FY 2021, which is $304,162. This is
estimated to provide a total of $20,378,854, representing 51 percent
(rounded to the nearest whole number) of the FY 2022 target revenue
amount.

C. Initial and Annual BPD Fees, Reactivation Fees

    To estimate the number of BPD fees to be paid in FY 2022, FDA must
consider the number of new BPD programs, the number of current BPD
programs, and the number of BPD programs that will be reactivated.
These estimates provide information that, when aggregated, allows FDA
to set BPD fees (initial BPD fees, annual BPD fees, reactivation fees).
    FDA analyzes available data to estimate the total number of BPD
programs for FY 2022. In FY 2022, FDA estimates 39 new BPD programs, no
reactivations (a single reactivation is weighted as two BPD fees), and
91 BPD programs (out of 92 invoiced) to pay the annual BPD fee,
yielding a total estimated equivalent of 130 BPD fees to be collected
in FY 2022.
    The remainder of the target revenue of $7,433,931, or 19 percent
(rounded to the nearest whole number), is to be collected from the BPD
fees. Dividing this amount by the estimated 130 BPD fees to be paid
equals an initial BPD and annual BPD fee amount of $57,184. The
reactivation fee is set at twice the initial/annual BPD amount at
$114,368 (rounded to the nearest dollar). This represents a reduction
of the BPD fees from the FY 2021 levels.

IV. Fee Schedule for FY 2022

    The fee rates for FY 2022 are displayed in table 7.

                    Table 7--Fee Schedule for FY 2022
------------------------------------------------------------------------
                                                           Fee rates for
                      Fee category                            FY 2022
------------------------------------------------------------------------
Initial BPD.............................................         $57,184
Annual BPD..............................................          57,184
Reactivation............................................         114,368
Applications:
  Requiring clinical data...............................       1,746,745
  Not requiring clinical data...........................         873,373
Program.................................................         304,162
------------------------------------------------------------------------

V. Fee Payment Options and Procedures

A. Initial BPD, Reactivation, and Application Fees

    The fees established in the new fee schedule apply to FY 2022,
i.e., the period from October 1, 2021, through September 30, 2022. The
initial BPD fee for a product is due when the sponsor submits an IND
that FDA determines is intended to support a biosimilar biological
product application for the product or within 5 calendar days after FDA
grants the first BPD meeting for the product, whichever occurs first.
Sponsors who have discontinued participation in the BPD program for a
product and seek to resume participation in such program must pay the
reactivation fee by the earlier of the following dates: No later than 5
calendar

days after FDA grants the sponsor's request for a BPD meeting for that
product or upon the date of submission by the sponsor of an IND
describing an investigation that FDA determines is intended to support
a biosimilar biological product application for that product.
    The application fee for a biosimilar biological product is due upon
submission of the application (see section 744H(a)(2)(C) of the FD&C
Act).
    To make a payment of the initial BPD, reactivation, or application
fee, complete the Biosimilar User Fee Cover Sheet, available on FDA's
website (https://www.fda.gov/bsufa) and generate a user fee
identification (ID) number. Payment must be made in U.S. currency by
electronic check, check, bank draft, U.S. postal money order, or wire
transfer. The preferred payment method is online using electronic check
(Automated Clearing House (ACH) also known as eCheck) or credit card
(Discover, VISA, MasterCard, American Express). FDA has partnered with
the U.S. Department of the Treasury to use Pay.gov, a web-based payment
application, for online electronic payment. The Pay.gov feature is
available on the FDA website after the user fee ID number is generated.
Secure electronic payments can be submitted using the User Fees Payment
Portal at https://userfees.fda.gov/pay (Note: Only full payments are
accepted. No partial payments can be made online). Once you search for
your invoice, click ``Pay Now'' to be redirected to Pay.gov. Electronic
payment options are based on the balance due. Payment by credit card is
available for balances that are less than $25,000. If the balance
exceeds this amount, only the ACH option is available. Payments must be
made using U.S. bank accounts as well as U.S. credit cards.
    If a check, bank draft, or postal money order is submitted, make it
payable to the order of the Food and Drug Administration and include
the user fee ID number to ensure that the payment is applied to the
correct fee(s). Payments can be mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If a check,
bank draft, or money order is to be sent by a courier that requests a
street address, the courier should deliver your payment to: U.S. Bank,
Attention: Government Lockbox 979108, 1005 Convention Plaza, St. Louis,
MO 63101. (Note: This U.S. Bank address is for courier delivery only.
If you have any questions concerning courier delivery, contact U.S.
Bank at<PHONE_NUMBER>. This telephone number is only for questions about
courier delivery.) Please make sure that the FDA post office box number
(P.O. Box 979108) and ID number is written on the check, bank draft, or
postal money order.
    For payments made by wire transfer, include the unique user fee ID
number to ensure that the payment is applied to the correct fee(s).
Without the unique user fee ID number, the payment may not be applied.
The originating financial institution may charge a wire transfer fee.
Include applicable wire transfer fees with payment to ensure fees are
fully paid. Questions about wire transfer fees should be addressed to
the financial institution. The following account information should be
used to send payments by wire transfer: U.S. Department of the
Treasury, TREAS NYC, 33 Liberty St., New York, NY 10045, Acct. No.:
75060099, Routing No.: 021030004, SWIFT: FRNYUS33. FDA's tax
identification number is 53-0196965.

B. Annual BPD and Program Fees

    FDA will issue invoices with payment instructions for FY 2022
annual BPD and program fees under the new fee schedule in August 2021.
Payment will be due on October 1, 2021. If sponsors join the BPD
program after the annual BPD invoices have been issued in August 2021,
FDA will issue invoices in December 2021 to firms subject to fees for
FY 2022 that qualify for the annual BPD fee after the August 2021
billing. FDA will issue invoices in December 2021 for any annual
program fees for FY 2022 that qualify for fee assessments and were not
issued in August 2021.

    Dated: July 23, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16084 Filed 7-27-21; 8:45 am]
BILLING CODE 4164-01-P