[Federal Register Volume 87, Number 201 (Wednesday, October 19, 2022)]
[Notices]
[Pages 63530-63533]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-22716]
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NUCLEAR REGULATORY COMMISSION
[Docket No. 03033009; EA-2021-157; NRC-2022-0179]
Confirmatory Order Modifying License of Cammenga and Associates,
LLC
AGENCY: Nuclear Regulatory Commission.
ACTION: Confirmatory order; issuance.
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SUMMARY: The U.S. Nuclear Regulatory Commission (NRC) is issuing a
Confirmatory Order to Cammenga and Associates, LLC, as a result of a
successful alternative dispute resolution mediation session. The
commitments outlined in the Confirmatory Order were made as a part of a
settlement agreement concerning apparent violations by Cammenga and
Associates regarding the distribution of products containing byproduct
material (hydrogen-3) without the required licensing authorization.
DATES: The Confirmatory Order became effective on October 6, 2022.
ADDRESSES: Please refer to Docket ID NRC-2022-0179 when contacting the
NRC about the availability of information regarding this document. You
may obtain publicly available information related to this document
using any of the following methods:
Federal Rulemaking website: Go to https://www.regulations.gov and search for Docket ID NRC-2022-0179. Address
questions about Docket IDs in Regulations.gov to Stacy Schumann;
telephone: 301-415-0624; email: [email protected]. For technical
questions, contact the individual listed in the For Further
Information Contact section of this document.
NRC's Agencywide Documents Access and Management System
(ADAMS): You may obtain publicly available documents online in the
ADAMS Public Documents collection at https://www.nrc.gov/reading-rm/adams.html. To begin the search, select ``Begin Web-based ADAMS
Search.'' For problems with ADAMS, please contact the NRC's Public
Document Room (PDR) reference staff at 1-800-397-4209, 301-415-4737, or
by email to [email protected]. The Confirmatory Order modifying
license of Cammenga and Associates, LLC. is available in ADAMS under
Accession No. ML22278A182.
NRC's PDR: You may examine and purchase copies of public
documents, by appointment, at the NRC's PDR, Room P1 B35, One White
Flint North, 11555 Rockville Pike, Rockville, Maryland 20852. To make
an appointment to visit the PDR, please send an email to
[email protected] or call 1-800-397-4209 or 301-415-4737, between
8:00 a.m. and 4:00 p.m. Eastern Time (ET), Monday through Friday,
except Federal holidays.
FOR FURTHER INFORMATION CONTACT: Carmen Rivera-Diaz, Office of
Enforcement, U.S. Nuclear Regulatory Commission, Washington, DC 20555-
0001, telephone: 301-415-0296, email: [email protected].
SUPPLEMENTARY INFORMATION: The text of the order is attached.
Dated: October 14, 2022.
For the Nuclear Regulatory Commission.
Dori Willis,
Acting Director, Office of Enforcement.
Attachment--Confirmatory Order Modifying License of Cammenga and
Associates, LLC
UNITED STATES OF AMERICA
NUCLEAR REGULATORY COMMISSION
In the Matter of
Cammenga and Associates, Inc.
Dearborn, Michigan
Docket Nos. 03038679
License Nos. 21-26460-03E
SSD Registration No.: NR-0210-D-101-E
EA-21-157
CONFIRMATORY ORDER MODIFYING LICENSE
EFFECTIVE UPON ISSUANCE
I
Cammenga and Associates, LLC, (Cammenga or Licensee) is the
holder of Materials License No. 21-26460-03E and Sealed Source and
Device Registration (SSD) Certificate No. NR-0210-D-101-E issued by
the U.S. Nuclear Regulatory Commission (NRC) pursuant to Part 30 and
32 of Title 10 of the Code of Federal Regulations (10 CFR). The
license authorizes Cammenga to distribute products containing
byproduct material (tritium, hydrogen-3) to persons exempt from the
regulations. For the products authorized under License No. 21-26460-
03E, an SSD is required and is captured as a License Condition in
the license. The SSD identifies the models that are authorized for
distribution under the license.
This Confirmatory Order is the result of an agreement reached
during an alternative dispute resolution (ADR) mediation session
conducted on June 28, 2022.
II
The NRC conducted investigations in 2021 (OI Case No. 3-2021-
008) related to apparent violations by Cammenga regarding the
distribution of products containing byproduct material (hydrogen-3)
without the required licensing authorization.
On March 17, 2022, the NRC issued a letter to Cammenga that
detailed the results of the investigation and outlined two apparent
violations. The first apparent violation involved Cammenga's failure
to limit its distribution of self-luminous products to the products
authorized in its NRC License No. 21-26460-03E. The product was
listed on a redistributor's website as the Tritium Pry Bar.
Specifically, between late 2020 and January 27, 2021, the licensee
distributed to an unlicensed entity at least 25 Tritium Pry Bars
that were not included in the products authorized in NRC License No.
21-26460-03E, in accordance with NRC SSD registration certificate
No. NR-0210-D-101-E. The second apparent violation involved
Cammenga's failure to limit its distribution of self-luminous
products to the products authorized in its NRC License No. 21-26460-
03E. The product was listed on a redistributor's website as the
Tritium Glow Fob. Specifically, between late 2020 and January 27,
2021, the licensee distributed to an unlicensed entity at least 10
Tritium Glow Fobs that were not included in the products authorized
in NRC License No. 21-26460-03E, in accordance with NRC SSD
registration certificate No. NR-0210-D-101-E.
The failure to conduct activities in accordance with a license
is significant because it resulted in the NRC not being able to
conduct its regulatory responsibilities to ensure that the products
were safe for distribution to members of the public, and it
inhibited the process of regulatory oversight.
The NRC determined that regarding the first violation identified
in the March 17, 2022, letter, Cammenga's actions were willful.
Specifically, Cammenga distributed 25 products containing tritium,
identified in the March 17, 2022, letter as the Tritium Pry Bar. The
NRC's determination of willfulness was not based on a finding that
Cammenga deliberately intended to violate NRC requirements, but
rather on Cammenga's careless disregard in failing to pursue
necessary actions to ensure Cammenga's compliance. Willful
violations are of significant concern to the NRC because the NRC's
regulatory programs rely upon the integrity of entities, applicants,
and licensees
[[Page 63531]]
to comply with NRC regulations and requirements.
For both violations identified in the March 17, 2022, letter,
the NRC considered whether Cammenga had taken corrective actions to
restore and maintain compliance. The insufficient information
regarding Cammenga's corrective actions warranted a response by the
licensee to the final action including providing a detailed
description of its corrective actions.''
In the March 17, 2022, letter, the NRC offered Cammenga the
choice to: (1) respond in writing to the apparent violations
addressed in the NRC's inspection report within 30 days of the date
of the letter; (2) request a Pre-decisional Enforcement Conference
(PEC); or (3) request ADR mediation. Cammenga requested ADR.
On June 28, 2022, Cammenga and the NRC met in an ADR session
mediated by a professional mediator, arranged through Cornell
University's Institute on Conflict Resolution. The ADR process is
one in which a neutral mediator, with no decision-making authority,
assists the parties in reaching an agreement on resolving any
differences regarding the dispute. This Confirmatory Order is issued
pursuant to the agreement reached during the ADR process.
III
As a result of an ADR mediation session held on June 28, 2022,
NRC and Cammenga reached a preliminary agreement. The elements of
the agreement, as signed by both parties on June 28, 2022, consisted
of the following:
1. Cammenga shall issue a company policy statement to its
employees regarding the importance of regulatory compliance.
a. The Policy Statement regarding Regulatory Compliance shall
provide Cammenga management's position on (1) the importance of
ensuring full understanding of the regulatory and license
requirements, (2) the ethics of complying with regulatory
requirements, (3) the awareness that willful violations are
unacceptable, pursuant to the requirements of 10 CFR 30.9 and 30.10,
(4) that there are potential criminal sanctions that the Department
of Justice may take against individuals for deliberate misconduct,
and (5) the need to ensure the primacy of regulatory compliance over
competing goals.
b. Within 60 days of the date of the Confirmatory Order,
Cammenga shall create and provide copies of the company policy
statement to all employees.
c. Within 60 days of the date of the Confirmatory Order,
Cammenga shall provide a copy of company policy statement to the
NRC.
d. Cammenga shall maintain copies of the company policy
statement for NRC inspection.
2. Cammenga shall issue a letter to its current resellers
articulating the existence of regulatory requirements, the
importance of distributing only products that are authorized, and
the importance of asking their suppliers to confirm that the product
is properly authorized.
a. Within 60 days of the date of the Confirmatory Order,
Cammenga shall issue the letter to current resellers.
b. Within 60 days of the date of the Confirmatory Order,
Cammenga shall provide a copy of the letter to the NRC.
c. Cammenga shall maintain copies of the letter for NRC
inspection.
3. Cammenga shall conduct initial and annual refresher training
for all engineering and management personnel that are responsible
for ensuring compliance with all active NRC Exempt Distribution
Licenses and Sealed Source and Device Certificates. The training
shall consist of reviewing all active NRC Exempt Distribution
Licenses and Sealed Source and Device Certificates.
a. Cammenga shall maintain documentation for training completed.
The training documentation shall include a summary of the contents
of the training and the individuals completing the training. The
training documentation shall be maintained for 5 years. The training
can be a read-and-sign.
b. Within 60 days of the date of the Confirmatory Order,
Cammenga shall conduct the initial training for all current
individuals engaged in licensed activities.
c. For individuals not currently engaged in the above
activities, Cammenga shall conduct initial training prior to
engagement in relevant activities.
d. By December 31 of each calendar year, Cammenga shall conduct
annual refresher training for all individuals engaged in relevant
activities.
e. Cammenga shall maintain copies of the training documentation
for NRC inspection.
4. Within 90 days of the date of the CO, Cammenga shall create
and maintain and implement written procedures to ensure that only
products approved on the distribution license shall be distributed.
The procedures will be available for NRC inspection.
5. Within 90 days of the date of the CO, Cammenga shall create
and maintain written procedures for a process for new or changed
designs to ensure the design either (1) fits within what is
currently authorized, or (2) an amendment is submitted and approved
by the NRC prior to distribution. The process will include a step to
assess if it is appropriate to request a pre-application meeting
with NRC. The procedures will be available for NRC inspection.
6. Cammenga commits to cease distribution of the Tritium Pry Bar
and Tritium Glow Fob (Cammenga will provide the product number for
these two models for the CO), until such time as Cammenga receives
written confirmation from NRC that the model is approved.
7. Within 180 days of the date of the CO, Cammenga will perform
an audit of all current models in inventory or production to confirm
products are authorized for distribution.
a. Cammenga will not distribute any models not confirmed
authorized for distribution.
b. Cammenga will document the review. The documentation will
include the following: list of models reviewed, determination
whether the model is authorized for distribution, and if authorized,
the number of the associated SSD and drawing number.
c. The documentation will be available for NRC inspection and
will be maintained for three years.
8. Cammenga will perform an annual assessment of program and
compliance for NRC License No. 21-26460-03E. The review will
specifically include: review for implementation of appropriate
procedures, verification that training was completed and documented
as per the ADR CO, and that all new/changed products were reviewed
under the new/change product process. Cammenga will maintain
documentation of the review. The documentation will be available for
NRC inspection, and will be maintained for at least three years.
a. By December 31 of each calendar year, Cammenga shall conduct
an annual assessment of program and compliance.
9. Cammenga shall pay a civil penalty of $5000.
a. Within 30 days of the date of the Confirmatory Order,
Cammenga shall pay a civil penalty of $5000. Cammenga shall pay the
civil penalty in accordance with NUREG/BR-0254, ``Payment Methods''.
b. Within 45 days of the date of the Confirmatory Order,
Cammenga shall submit to the NRC, a statement indicating when and by
what method payment was made.
On September 21, 2022, Cammenga consented to issuing this
Confirmatory Order with the commitments, as described in Section V
below. Cammenga further agreed that this Confirmatory Order is to be
effective upon issuance of the Confirmatory Order and that it has
waived its right to a hearing.
IV
Since the licensee has agreed to take additional actions to
address NRC concerns, as set forth in Section III above, the NRC has
concluded that its concerns can be resolved through issuance of this
Confirmatory Order.
I find that Cammenga's commitments as set forth in Section V are
acceptable and necessary and conclude that with these commitments
the public health and safety are reasonably assured. In view of the
foregoing, I have determined that public health and safety require
that Cammenga's commitments be confirmed by this Confirmatory Order.
Based on the above and Cammenga's consent, this Confirmatory Order
is effective upon issuance of the Confirmatory Order.
V
Accordingly, pursuant to Sections 81,161b, 161i, 161o, 182 and
186 of the Atomic Energy Act of 1954, as amended, and the
Commission's regulations in 10 CFR 2.202 and 10 CFR part 30, it is
hereby ordered that license No. 21-26460-03E is modified as follows:
1. Cammenga shall issue a company policy statement to its
employees regarding the importance of regulatory compliance.
a. The Policy Statement regarding Regulatory Compliance shall
provide Cammenga management's position on (1) the importance of
ensuring full understanding of the regulatory and license
requirements, (2) the ethics of complying with regulatory
requirements, (3) that willful violations are unacceptable, pursuant
to the requirements of 10 CFR 30.9 and 30.10, (4) that there are
[[Page 63532]]
potential criminal sanctions that the Department of Justice may take
against individuals for deliberate misconduct, and (5) the need to
ensure the primacy of regulatory compliance over competing goals.
b. Within 60 days of the date of the Confirmatory Order,
Cammenga shall create and provide copies of the company policy
statement to all employees.
c. Within 60 days of the date of the Confirmatory Order,
Cammenga shall create and provide copies of the company policy
statement to the NRC.
d. Cammenga shall maintain copies of the company policy
statement for NRC inspection.
2. Cammenga shall issue a letter to its current resellers
articulating the existence of regulatory requirements, the
importance of distributing only products that are authorized, and
the importance of asking their suppliers to confirm that the product
is properly authorized.
a. Within 60 days of the date of the Confirmatory Order,
Cammenga shall issue the letter to current resellers.
b. Within 60 days of the date of the Confirmatory Order,
Cammenga shall provide a copy of the letter to the NRC.
c. Cammenga shall maintain copies of the letter for NRC
inspection.
3. Cammenga shall conduct initial and annual refresher training
for all engineering and management personnel that are responsible
for ensuring compliance with any active NRC Exempt Distribution
Licenses and Sealed Source and Device Certificates. The training
shall consist of reviewing all active NRC Exempt Distribution
Licenses and Sealed Source and Device Certificates.
a. Cammenga shall maintain documentation for training completed.
The training documentation shall include a summary of the contents
of the training and the individuals completing the training. The
training documentation shall be maintained for five years. The
training can be a read-and-sign.
b. Within 60 days of the date of the Confirmatory Order,
Cammenga shall conduct the initial training for all current
individuals engaged in licensed activities.
c. For individuals not currently engaged in licensed activities,
Cammenga shall conduct initial training prior to engagement in such
activities.
d. By December 31 of each calendar year, Cammenga shall conduct
annual refresher training for all individuals engaged in such
activities.
e. Cammenga shall maintain copies of the training documentation
for NRC inspection.
4. Within 90 days of the date of the Confirmatory Order,
Cammenga shall create, maintain, and implement written procedures to
ensure that only products approved on the distribution license shall
be distributed. The procedures shall be available for NRC
inspection.
5. Within 90 days of the date of the Confirmatory Order,
Cammenga shall create, maintain, and implement written procedures
for a process for new or changed designs to ensure that either (1)
the design fits within what is currently authorized, or (2) a
license amendment is submitted and approved by the NRC prior to
distribution. The process shall include a step to assess whether it
is appropriate to request a pre-application meeting with NRC. The
procedures shall be available for NRC inspection.
6. Cammenga shall cease distribution of the Tritium Pry Bar and
Tritium Glow Fob, until such time as Cammenga receives written
confirmation from NRC that the models are approved.
7. Within 180 days of the date of the Confirmatory Order,
Cammenga shall perform an audit of all current models in inventory
or production to confirm the products are authorized for
distribution.
a. Cammenga shall not distribute any models not confirmed as
authorized for distribution.
b. Cammenga shall document the audit review. The documentation
shall include (1) the list of models reviewed, (2) determination of
whether the model is authorized for distribution, and if authorized,
(3) the associated SSD number and drawing number.
c. The documentation shall be available for NRC inspection, and
Cammenga shall maintain the documentation for three years.
8. Cammenga shall perform an annual assessment of program and
compliance for NRC License No. 21-26460-03E. The assessment shall
specifically include: (1) review for implementation of appropriate
procedures, (2) verification that training was completed and
documented as per the ADR Confirmatory Order, and (3) verification
that all new/changed products have been reviewed under the new/
change product process established in accordance with paragraph 5
above. Cammenga shall maintain documentation of the assessment. The
documentation shall be available for NRC inspection, and Cammenga
shall maintain the documentation for at least three years.
a. By December 31 of each calendar year, Cammenga shall conduct
an annual assessment of program and compliance.
9. Cammenga shall pay a civil penalty of $5000.
a. Within 30 days of the date of the Confirmatory Order,
Cammenga shall pay a civil penalty of $5000. Cammenga shall pay the
civil penalty through one of the following methods:
i. Submit the payment with the enclosed invoice to this Order
(EA-21-157) to the following address: Office of the Chief Financial
Officer, U.S. Nuclear Regulatory Commission, P.O. Box 979051, St.
Louis, MO 63197, OR
ii. Submit the payment in accordance with NUREG/BR-0254,
``Payment Methods''.
b. Within 45 days of the date of the Confirmatory Order,
Cammenga shall submit to the NRC, a written statement indicating
when and by what method payment was made to the Director, Office of
Enforcement, U.S. Nuclear Regulatory Commission, One White Flint
North, 11555 Rockville Pike, Rockville, MD 20852-2738.
The NRC considers the corrective actions discussed above to be
appropriately prompt and comprehensive.
The NRC agrees not to pursue any further enforcement action in
connection with the NRC's March 17, 2022, letter to Cammenga.
The Confirmatory Order shall constitute escalated enforcement
action.
This agreement is binding upon successors and assigns of NRC
License No. 21-26460-03E.
In the event of the transfer of the possession and/or
distribution licenses of Cammenga to another entity, the terms and
conditions set forth hereunder shall continue to apply to the new
entity and accordingly survive any transfer of ownership or license.
Unless otherwise specified, all dates are from the date of
issuance of the Confirmatory Order.
Unless otherwise specified, all documents required to be
submitted to the NRC shall be sent to: Director, Office of
Enforcement, U.S. Nuclear Regulatory Commission, One White Flint
North, 11555 Rockville Pike, Rockville, MD 20852-2738, with a copy
to the Director, Materials Safety, Security, State, and Tribal
Programs, Two White Flint North, 11545 Rockville Pike, Rockville, MD
20852-2738. Cammenga will also endeavor to provide courtesy
electronic copies to the above individuals.
The Director, Office of Enforcement, may, in writing, relax or
rescind any of the above conditions upon demonstration by the
Licensee of good cause.
VI
In accordance with 10 CFR 2.202 and 10 CFR 2.309, any person
adversely affected by this Confirmatory Order, other than Cammenga,
may request a hearing within thirty (30) calendar days of the date
of issuance of this Confirmatory Order. Where good cause is shown,
consideration will be given to extending the time to request a
hearing. A request for extension of time must be made in writing to
the Director, Office of Enforcement, U.S. Nuclear Regulatory
Commission, Washington, DC 20555, and include a statement of good
cause for the extension.
All documents filed in NRC adjudicatory proceedings including
documents filed by an interested State, local governmental body,
federally recognized Indian Tribes, or designated agency thereof
that requests to participate under 10 CFR 2.315(c), must be filed in
accordance with 10 CFR 2.302. The E-Filing process requires
participants to submit and serve all adjudicatory documents over the
internet, or in some cases, to mail copies on electronic storage
media, unless an exemption permitting an alternative filing method,
as further discussed, is granted. Detailed guidance on electronic
submissions is located in the ``Guidance for Electronic Submissions
to the NRC'' (ADAMS Accession No. ML13031A056) and on the NRC's
public website at https://www.nrc.gov/site-help/e-submittals.html.
To comply with the procedural requirements of E-Filing, at least
10 days prior to the filing deadline, the participant should contact
the Office of the Secretary by email at [email protected], or
by telephone at 301-415-1677, to (1) request a digital
identification (ID) certificate, which allows the participant (or
its counsel or representative) to digitally sign submissions and
access the E-Filing system for any proceeding in which it is
participating; and (2) advise the Secretary that the participant
will be submitting a petition or other
[[Page 63533]]
adjudicatory document (even in instances in which the participant,
or its counsel or representative, already holds an NRC-issued
digital ID certificate). Based upon this information, the Secretary
will establish an electronic docket for the proceeding if the
Secretary has not already established an electronic docket.
Information about applying for a digital ID certificate is
available on the NRC's public website at https://www.nrc.gov/site-help/e-submittals/getting-started.html. After a digital ID
certificate is obtained and a docket created, the participant must
submit adjudicatory documents in Portable Document Format. Guidance
on submissions is available on the NRC's public website at https://www.nrc.gov/site-help/electronic-sub-ref-mat.html. A filing is
considered complete at the time the document is submitted through
the NRC's E-Filing system. To be timely, an electronic filing must
be submitted to the E-Filing system no later than 11:59 p.m. ET on
the due date. Upon receipt of a transmission, the E-Filing system
time-stamps the document and sends the submitter an email confirming
receipt of the document. The E-Filing system also distributes an
email that provides access to the document to the NRC's Office of
the General Counsel and any others who have advised the Office of
the Secretary that they wish to participate in the proceeding, so
that the filer need not serve the document on those participants
separately. Therefore, applicants and other participants (or their
counsel or representative) must apply for and receive a digital ID
certificate before adjudicatory documents are filed to obtain access
to the documents via the E-Filing system.
A person filing electronically using the NRC's adjudicatory E-
Filing system may seek assistance by contacting the NRC's Electronic
Filing Help Desk through the ``Contact Us'' link located on the
NRC's public website at https://www.nrc.gov/site-help/e-submittals.html, by email to [email protected], or by a toll-
free call at 1-866-672-7640. The NRC Electronic Filing Help Desk is
available between 9:00 a.m. and 6:00 p.m., ET, Monday through
Friday, except Federal holidays.
Participants who believe that they have good cause for not
submitting documents electronically must file an exemption request,
in accordance with 10 CFR 2.302(g), with their initial paper filing
stating why there is good cause for not filing electronically and
requesting authorization to continue to submit documents in paper
format. Such filings must be submitted in accordance with 10 CFR
2.302(b)-(d). Participants filing adjudicatory documents in this
manner are responsible for serving their documents on all other
participants. Participants granted an exemption under 10 CFR
2.302(g)(2) must still meet the electronic formatting requirement in
10 CFR 2.302(g)(1), unless the participant also seeks and is granted
an exemption from 10 CFR 2.302(g)(1).
Documents submitted in adjudicatory proceedings will appear in
the NRC's electronic hearing docket, which is publicly available at
https://adams.nrc.gov/ehd, unless excluded pursuant to an order of
the presiding officer. If you do not have an NRC-issued digital ID
certificate as previously described, click ``cancel'' when the link
requests certificates and you will be automatically directed to the
NRC's electronic hearing dockets where you will be able to access
any publicly available documents in a particular hearing docket.
Participants are requested not to include personal privacy
information such as social security numbers, home addresses, or
personal phone numbers in their filings unless an NRC regulation or
other law requires submission of such information. With respect to
copyrighted works, except for limited excerpts that serve the
purpose of the adjudicatory filings and would constitute a Fair Use
application, participants should not include copyrighted materials
in their submission.
If a person other than the licensee requests a hearing, that
person shall set forth with particularity the manner in which his
interest is adversely affected by this Confirmatory Order and shall
address the criteria set forth in 10 CFR 2.309(d) and (f).
If a hearing is requested by a person whose interest is
adversely affected, the Commission will issue a separate Order
designating the time and place of any hearings, as appropriate. If a
hearing is held, the issue to be considered at such hearing shall be
whether this Confirmatory Order should be sustained.
In the absence of any request for hearing, or written approval
of an extension of time in which to request a hearing, the
provisions specified in Section V above shall be effective and final
30 days after issuance of the Confirmatory Order without further
order or proceedings. If an extension of time for requesting a
hearing has been approved, the provisions specified in Section V
shall be final when the extension expires if a hearing request has
not been received.
For the Nuclear Regulatory Commission.
Mark D. Lombard,
Director, Office of Enforcement.
Dated this 6th day of October 2022.
[FR Doc. 2022-22716 Filed 10-18-22; 8:45 am]
BILLING CODE 7590-01-P