[Federal Register: April 22, 2010 (Volume 75, Number 77)]
[Rules and Regulations]
[Page 20913-20917]
[DOCID:fr22ap10-4]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 801, 803, 807, 812, 814, 820, 822, 860, 900, 1002,
and 1040

[Docket No. FDA-2010-N-0010]

Center for Devices and Radiological Health; New Address
Information

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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SUMMARY: The Food and Drug Administration (FDA) is amending procedural
regulations that pertain to obtaining, submitting, executing, and
filing certain documents to reflect new address information for the
Center for Devices and Radiological Health (CDRH). All filings and
other documents that are subject to these regulations must be directed
to the new addresses. This action is being taken to provide accuracy
and clarity to the agency's regulations.

DATES: This regulation is effective April 22, 2010.

FOR FURTHER INFORMATION CONTACT:  Domini Bean, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, rm. 4422, Silver Spring, MD 20993-0002, 301-
796-5733.

SUPPLEMENTARY INFORMATION: FDA is amending its regulations in 21 CFR
parts 1, 801, 803, 807, 812, 814, 820, 822, 860, 900, 1002, and 1040 to
reflect new address information for certain components of the agency's
CDRH. The changes are the result of the relocation of these offices to
FDA's White Oak campus.
    Publication of this document constitutes final action under the
Administrative Procedures Act (5 U.S.C. 553). FDA has determined that
notice and public comment are unnecessary because this amendment to the
regulations provides only technical changes to update mailing addresses
and other information, and is nonsubstantive.

List of Subjects

21 CFR Part 1

    Cosmetics, Drugs, Exports, Food labeling, Imports, Labeling,
Reporting and recordkeeping requirements.

21 CFR Part 801

    Incorporation by reference, Labeling, Medical devices, Reporting
and recordkeeping requirements.

21 CFR Part 803

    Imports, Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 807

    Confidential business information, Imports, Medical devices,
Reporting and recordkeeping requirements.

21 CFR Part 812

    Health records, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Part 814

    Administrative practice and procedure, Confidential business
information, Medical devices, Medical research, Reporting and
recordkeeping requirements.

21 CFR Parts 820 and 822

    Medical devices, Reporting and recordkeeping requirements.

21 CFR Part 860

    Administrative practice and procedure, Medical devices.

21 CFR Part 900

    Electronic products, Health facilities, Medical devices, Radiation
protection, Reporting and recordkeeping requirements, X-rays.

21 CFR Part 1002

     Electronic products, Radiation protection, Reporting and
recordkeeping requirements.

21 CFR Part 1040

    Electronic products, Labeling, Lasers, Medical devices, Radiation
protection, Reporting and recordkeeping requirements.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR
Chapter I is amended as follows:

PART 1--GENERAL ENFORCEMENT REGULATIONS

0
1. The authority citation for 21 CFR part 1 continues to read as
follows:

    Authority: 15 U.S.C. 1453, 1454, 1455; 19 U.S.C. 1490, 1491; 21
U.S.C. 321, 331, 332, 333, 334, 335a, 343, 350c, 350d, 352, 355,
360b, 362, 371, 374, 381, 382, 393; 42 U.S.C. 216, 241, 243, 262,
264.

0
2. Section 1.101 is amended by revising paragraph (d)(2)(iii) to read
as follows:

Sec.  1.101  Notification and recordkeeping.

* * * * *
    (d) * * *
    (2) * * *
    (iii) For devices--Food and Drug Administration, Center for Devices
and Radiological Health, Division of Program Operations, 10903 New
Hampshire Ave., Bldg. 66, rm. 5429, Silver Spring, MD 20993-0002.
* * * * *

PART 801--LABELING

0
3. The authority citation for 21 CFR part 801 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360i, 360j, 371, 374.

0
4. Section 801.430 is amended by revising the text of footnote number 1
in paragraph (f)(2) to read as follows:

Sec.  801.430  User labeling for menstrual tampons.

* * * * *
    (f) * * *
    (2) * * *
    \1\The Director of the Federal Register approves this incorporation
by reference in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. You
may obtain a copy from the American Society for Testing and Materials
International, 100 Barr Harbor Dr., P.O. Box C700, West Conshohocken,
PA 19428-2959,<PHONE_NUMBER>, www.astm.org. You may inspect a copy at
the FDA Main Library, 10903 New Hampshire Ave., Bldg. 2, 3d floor,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>, or at the National Archives
and Records Administration (NARA). For information on the availability
of this material at NARA, call<PHONE_NUMBER>, or go to: http://
www.archives.gov/federal_register/code_of_federal_regulations/ibr_
locations.html.
* * * * *

PART 803--MEDICAL DEVICE REPORTING

0
5. The authority citation for 21 CFR part 803 continues to read as
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

0
6. Section 803.11 is amended by revising paragraph (c) to read as
follows:

Sec.  803.11  What form should I use to submit reports of individual
adverse events and where do I obtain these forms?

* * * * *
    (c) Food and Drug Administration, Center for Devices and
Radiological Health, Division of Small Manufacturers, International and
Consumer Assistance, 10903 New Hampshire Ave., Bldg. 66, rm. 4521,
Silver Spring, MD 20993-0002.
* * * * *

0
7. Section 803.21 is amended by revising paragraph (a) to read as
follows:

Sec.  803.21  Where can I find the reporting codes for adverse events
that I use with medical device reports?

    (a) The MEDWATCH Medical Device Reporting Code Instruction Manual
contains adverse event codes for use with FDA Form 3500A. You may
obtain the coding manual from CDRH's Web site at http://www.fda.gov/
Safety/MedWatch/HowToReport/DownloadForms/ucm149238.htm.
* * * * *

PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES

0
8. The authority citation for 21 CFR part 807 continues to read as
follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.

0
9. Section 807.22 is amended by revising paragraph (a) to read as
follows:

Sec.  807.22  How and where to register establishments and list
devices.

    (a) The first registration of a device establishment shall be on
Form FDA-2891 (Initial Registration of Device Establishment). Forms are
available upon request from the Food and Drug Administration, Center
for Devices and Radiological Health, Office of Compliance, 10903 New
Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002, or
from Food and Drug Administration district offices. Subsequent annual
registration shall be accomplished on Form FDA-2891a (Annual
Registration of Device Establishment), which will be furnished by FDA
to establishments whose registration for that year was validated under
Sec.  807.35(a). The forms will be mailed to the owner or operators of
all establishments by the official correspondent in accordance with the
schedule as described in Sec.  807.21(a). The completed form shall be
mailed to the address designated in this paragraph 30 days after
receipt from FDA.
* * * * *

0
10. Section 807.37 is amended by revising paragraphs (a) and (b)(2) to
read as follows:

Sec.  807.37  Inspection of establishment registration and device
listings.

    (a) A copy of the forms FDA-2891 and FDA-2891a filed by the
registrant will be available for inspection in

accordance with section 510(f) of the act, at the Food and Drug
Administration, Center for Devices and Radiological Health, Office of
Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver
Spring, MD 20993-0002. In addition, there will be available for
inspection at each of the Food and Drug Administration district offices
the same information for firms within the geographical area of such
district office. Upon request, verification of registration number or
location of a registered establishment will be provided.
    (b) * * *
    (2) Requests for device listing information identified in paragraph
(b)(1) of this section should be directed to the Food and Drug
Administration, Center for Devices and Radiological Health, Office of
Compliance, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver
Spring, MD 20993-0002.
* * * * *

0
11. Section 807.90 is amended by revising paragraph (a)(1) to read as
follows:

Sec.  807.90  Format of a premarket notification submission.

* * * * *
    (a)(1) For devices regulated by the Center for Devices and
Radiological Health, be addressed to the Food and Drug Administration,
Center for Devices and Radiological Health, Document Mail Center, 10903
New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.
* * * * *

PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS

0
12. The authority citation for 21 CFR part 812 continues to read as
follows:

    Authority:  21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f,
360h-360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241,
262, 263b-263n.

0
13. Section 812.19 is amended by revising paragraph (a)(1) to read as
follows:

Sec.  812.19  Address for IDE correspondence.

    (a) * * *
    (1) For devices regulated by the Center for Devices and
Radiological Health, send it to Food and Drug Administration, Center
for Devices and Radiological Health, Document Mail Center, 10903 New
Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.
* * * * *

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
14. The authority citation for 21 CFR part 814 continues to read as
follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372,
373, 374, 375, 379, 379e, 381.

0
15. Section 814.20 is amended by revising paragraph (h)(1) to read as
follows:

Sec.  814.20  Application.

* * * * *
    (h) * * *
    (1) For devices regulated by the Center for Devices and
Radiological Health, Food and Drug Administration, Center for Devices
and Radiological Health, Document Mail Center, 10903 New Hampshire
Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.
* * * * *

0
16. Section 814.104 is amended by revising paragraph (d)(1) to read as
follows:

Sec.  814.104  Original applications.

* * * * *
    (d) * * *
    (1) For devices regulated by the Center for Devices and
Radiological Health, send to Document Mail Center, 10903 New Hampshire
Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.
* * * * *

PART 820--QUALITY SYSTEM REGULATION

0
17. The authority citation for 21 CFR part 820 continues to read as
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360c, 360d, 360e, 360h,
360i, 360j, 360l, 371, 374, 381, 383; 42 U.S.C. 216, 262, 263a, 264.

0
18. Section 820.1 is amended by revising paragraph (e)(1) to read as
follows:

Sec.  820.1  Scope.

* * * * *
    (e) * * * (1) Any person who wishes to petition for an exemption or
variance from any device quality system requirement is subject to the
requirements of section 520(f)(2) of the act. Petitions for an
exemption or variance shall be submitted according to the procedures
set forth in Sec.  10.30 of this chapter, the FDA's administrative
procedures. Guidance is available from the Food and Drug
Administration, Center for Devices and Radiological Health, Division of
Small Manufacturers, International and Consumer Assistance, 10903 New
Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002, 1-
800-638-2041 or<PHONE_NUMBER>, FAX:<PHONE_NUMBER>.
* * * * *

PART 822--POSTMARKET SURVEILLANCE

0
19. The authority citation for 21 CFR part 822 continues to read as
follows:

    Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

0
20. Section 822.8 is revised to read as follows:

Sec.  822.8  When, where, and how must I submit my postmarket
surveillance plan?

    You must submit your plan to conduct postmarket surveillance within
30 days of the date you receive the postmarket surveillance order. For
devices regulated by the Center for Biologics Evaluation and Research,
send three copies of your submission to the Document Control Center
(HFM-99), Center for Biologics Evaluation and Research, Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448. For devices regulated by the Center for Drug Evaluation and
Research, send three copies of your submission to the Central Document
Room, Center for Drug Evaluation and Research, Food and Drug
Administration, 5901-B, Ammendale Rd., Beltsville, MD 20705-1266. For
devices regulated by the Center for Devices and Radiological Health,
send three copies of your submission to the Document Mail Center, 10903
New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002.
When we receive your original submission, we will send you an
acknowledgment letter identifying the unique document number assigned
to your submission. You must use this number in any correspondence
related to this submission.

0
21. Section 822.12 is revised to read as follows:

Sec.  822.12  Do you have any information that will help me prepare my
submission or design my postmarket surveillance plan?

    Guidance documents that discuss our current thinking on preparing a
postmarket surveillance submission and designing a postmarket
surveillance plan are available on the Center for Devices and
Radiological Health's Web site and from the Food and Drug
Administration, Center for Devices and Radiological Health, Office of
Surveillance and Biometrics, 10903 New Hampshire Ave., Bldg. 66, rm.
3219, Silver Spring, MD 20993-0002. Guidance documents represent our
current interpretation of, or policy on, a regulatory issue. They do
not establish

legally enforceable rights or responsibilities and do not legally bind
you or FDA. You may choose to use an approach other than the one set
forth in a guidance document, as long as your alternative approach
complies with the relevant statutes (laws) and regulations. If you
wish, we will meet with you to discuss whether an alternative approach
you are considering will satisfy the requirements of the act and
regulations.

PART 860--MEDICAL DEVICE CLASSIFICATION PROCEDURES

0
22. The authority citation for 21 CFR part 860 continues to read as
follows:

    Authority: 21 U.S.C. 360c, 360d, 360e, 360i, 360j, 371, 374.

0
23. Section 860.123 is amended by revising paragraph (b)(1) to read as
follows:

Sec.  860.123  Reclassification petition: Content and form.

* * * * *
    (b) * * *
    (1) For devices regulated by the Center for Devices and
Radiological Health, addressed to the Food and Drug Administration,
Center for Devices and Radiological Health, Regulations Staff, 10903
New Hampshire Ave., Bldg. 66, rm. 4425, Silver Spring, MD 20993-0002;
for devices regulated by the Center for Biologics Evaluation and
Research, addressed to the Document Control Center (HFM-99), Center for
Biologics Evaluation and Research, Food and Drug Administration, 1401
Rockville Pike, suite 200N, Rockville, MD 20852-1448; for devices
regulated by the Center for Drug Evaluation and Research, addressed to
the Central Document Control Room, Center for Drug Evaluation and
Research, Food and Drug Administration, 5901-B Ammendale Rd.,
Beltsville, MD 20705-1266, as applicable.
* * * * *

PART 900--MAMMOGRAPHY

0
24. The authority citation for 21 CFR part 900 continues to read as
follows:

    Authority: 21 U.S.C. 360i, 360nn, 374(e); 42 U.S.C. 263b.

0
25. Section 900.15 is amended by revising paragraph (d)(3)(i) to read
as follows:

Sec.  900.15  Appeals of adverse accreditation or reaccreditation
decisions that preclude certification or recertification.

* * * * *
    (d) * * *
    (3) * * *
    (i) A facility must request reconsideration by DMQRP within 60 days
of the accreditation body's adverse appeals decision, at the following
address: Food and Drug Administration, Center for Devices and
Radiological Health, Division of Mammography Quality and Radiation
Programs, Attn: Facility Accreditation Review Committee, 10903 New
Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-0002.
* * * * *

0
26. Section 900.18 is amended by revising paragraph (c) introductory
text to read as follows:

Sec.  900.18  Alternative requirements for Sec.  900.12 quality
standards.

* * * * *
    (c) Applications for approval of an alternative standard. An
application for approval of an alternative standard or for an amendment
or extension of the alternative standard shall be submitted in an
original and two copies to the Food and Drug Administration, Center for
Devices and Radiological Health, Director, Division of Mammography
Quality and Radiation Programs, 10903 New Hampshire Ave., Bldg. 66, rm.
4521, Silver Spring, MD 20993-0002. The application for approval of an
alternative standard shall include the following information:
* * * * *

0
27. Section 900.21 is amended by revising paragraph (b)(1) to read as
follows:

Sec.  900.21  Application for approval as a certification agency.

* * * * *
    (b) * * * (1) An applicant seeking FDA approval as a certification
agency shall inform the Food and Drug Administration, Center for
Devices and Radiological Health, Director, Division of Mammography
Quality and Radiation Programs, Attn: States as Certifiers Coordinator,
10903 New Hampshire Ave., Bldg. 66, rm. 4521, Silver Spring, MD 20993-
0002, in writing, of its desire to be approved as a certification
agency.
* * * * *

PART 1002--RECORDS AND REPORTS

0
28. The authority citation for 21 CFR part 1002 continues to read as
follows:

    Authority: 21 U.S.C. 352, 360, 360i, 360j, 360hh-360ss, 371,
374.

0
29. Section 1002.7 is amended by revising the introductory text to read
as follows:

Sec.  1002.7  Submission of data and reports.

    All submissions such as reports, test data, product descriptions,
and other information required by this part, or voluntarily submitted
to the Director, Center for Devices and Radiological Health, shall be
filed with the number of copies as prescribed by the Director, Center
for Devices and Radiological Health, and shall be signed by the person
making the submission. The submissions required by this part shall be
addressed to the Food and Drug Administration, Center for Devices and
Radiological Health, ATTN: Electronic Product Reports, Document Mail
Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD
20993-0002.
* * * * *

0
30. Section 1002.10 is amended by revising the introductory text to
read as follows:

Sec.  1002.10  Product reports.

    Every manufacturer of a product or component requiring a product
report as set forth in table 1 of Sec.  1002.1 shall submit a product
report to the Food and Drug Administration, Center for Devices and
Radiological Health, ATTN: Electronic Product Reports, Document Mail
Center, 10903 New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD
20993-0002, prior to the introduction of such product into commerce.
The report shall be distinctly marked ``Radiation Safety Product Report
of (name of manufacturer)'' and shall:
* * * * *

0
31. Section 1002.20 is amended by revising paragraph (b) introductory
text to read as follows:

Sec.  1002.20  Reporting of accidental radiation occurrences.

* * * * *
    (b) Such reports shall be addressed to Food and Drug
Administration, Center for Devices and Radiological Health, ATTN:
Accidental Radiation Occurrence Reports, Document Mail Center, 10903
New Hampshire Ave., Bldg. 66, rm. G609, Silver Spring, MD 20993-0002,
and the reports and their envelopes shall be distinctly marked ``Report
on 1002.20'' and shall contain all of the following information where
known to the manufacturer:
* * * * *

0
32. Section 1002.50 is amended by revising paragraph (c)(3) to read as
follows:

Sec.  1002.50  Special exemptions.

* * * * *
    (c) * * *
    (3) Such conditions as are deemed necessary to protect the public
health and safety. Copies of exemptions shall

be available upon request from the Food and Drug Administration, Center
for Devices and Radiological Health, Division of Mammography Quality
and Radiation Programs, 10903 New Hampshire Ave., Bldg. 66, rm. 4521,
Silver Spring, MD 20993-0002.
* * * * *

PART 1040--PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

0
33. The authority citation for 21 CFR part 1040 continues to read as
follows:

    Authority: 21 U.S.C. 351, 352, 360, 360e-360j, 371, 381; 42
U.S.C. 263B-263n.

0
34. Section 1040.10 is amended by revising paragraph (a)(3)(i) to read
as follows:

Sec.  1040.10  Laser products.

    (a) * * *
    (3) * * *
    (i) Registers, and provides a listing by type of such laser
products manufactured that includes the product name, model number and
laser medium or emitted wavelength(s), and the name and address of the
manufacturer. The manufacturer must submit the registration and listing
to the Food and Drug Administration, Center for Devices and
Radiological Health, Director, Office of Compliance, 10903 New
Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002.
* * * * *

0
35. Section 1040.20 is amended by revising paragraph (d)(3)(iii) to
read as follows:

Sec.  1040.20  Sunlamp products and ultraviolet lamps intended for use
in sunlamp products.

* * * * *
    (d) * * *
    (3) * * *
    (iii) If the size, configuration, design, or function of the
sunlamp product or ultraviolet lamp would preclude compliance with the
requirements for any required label or would render the required
wording of such label inappropriate or ineffective, or would render the
required label unnecessary, the Director, Office of Communication,
Education, and Radiation Programs 10903 New Hampshire Ave., Bldg. 66,
rm. 4312, Silver Spring, MD 20993-0002, Center for Devices and
Radiological Health, on the center's own initiative or upon written
application by the manufacturer, may approve alternate means of
providing such label(s), alternate wording for such label(s), or
deletion, as applicable.
* * * * *

    Dated: April 12, 2010.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2010-8863 Filed 4-21-10; 8:45 am]
BILLING CODE 4160-01-S


[Federal Register Volume 86, Number 63 (Monday, April 5, 2021)]
[Notices]
[Page 17592]
[FR Doc No: 2021-06495]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2020-0738; FRL-10021-81]

Chemical Category for Octahydro-Tetramethyl-Naphthalenyl-Ethanone
(OTNE); Manufacturer Request for Risk Evaluation Under the Toxic
Substances Control Act (TSCA); Extension of Comment Period

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; extension of comment period.

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SUMMARY: In the Federal Register notice of February 19, 2021, EPA
announced the availability of and solicited public comment on a
manufacturer request for a risk evaluation of ethanone, 1-
(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl),
ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-
naphthalenyl), ethanone, 1-(1,2,3,4,6,7,8,8a-octahydro-2,3,8,8-
tetramethyl-2-naphthalenyl), and ethanone, 1-(1,2,3,5,6,7,8,8a-
octahydro-2,3,8,8-tetramethyl-2-naphthalenyl) (collectively, ``OTNE'')
under the Toxic Substances Control Act (TSCA). This document extends
the comment period for 30 days from April 5, 2021 to May 5, 2021.

DATES: The comment period for the notice published February 19, 2021,
at 86 FR 10267, is extended. Comments, identified by docket
identification (ID) number EPA-HQ-OPPT-2020-0738, must be received on
or before May 5, 2021.

ADDRESSES: Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPPT-2020-0738, through the Federal eRulemaking
Portal at http://www.regulations.gov. Follow the online instructions
for submitting comments. Do not submit electronically any information
you consider to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute. To make special
arrangements for hand delivery or delivery of boxed information, please
follow the instructions at http://www.epa.gov/dockets/contacts.html.
    Please note that due to the public health emergency the EPA Docket
Center (EPA/DC) and Reading Room were closed to public visitors on
March 31, 2020. Our EPA/DC staff will continue to provide customer
service via email, phone, and webform. For further information on EPA/
DC services, docket contact information and the current status of the
EPA/DC and Reading Room, please visit https://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT:
    For technical information contact: Jeffrey Putt, Existing Chemicals
Risk Management Division (Mail Code 7404T), Office of Pollution
Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave. NW, Washington, DC 20460-0001; telephone number:
(202) 564-3703; email address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: This document extends the public comment
period established in the Federal Register document of February 19,
2021 (86 FR 10267) (FRL-10019-82), for 30 days, from April 5, 2021 to
May 5, 2021. In that document, EPA announced the availability of and
solicited public comment on a manufacturer request for a risk
evaluation of OTNE under the Toxic Substances Control Act (TSCA). More
information on the manufacturer request, risk evaluations under TSCA,
and EPA's solicitation of comment can be found in the Federal Register
issue of February 19, 2021.
    An extension of the comment period was requested by stakeholders to
allow interested parties additional time to thoroughly review the
inclusion of any additional conditions of use and potentially exposed
or susceptible subpopulations. The Agency is in the process of broadly
re-examining how it intends to implement these and other provisions of
amended TSCA including determining how new executive orders and other
direction provided by the Biden-Harris Administration will be
addressed. EPA agrees that an extension of the comment period is
warranted.
    To submit comments, or access the docket, please follow the
detailed instructions provided under ADDRESSES. If you have questions,
consult the technical persons listed under FOR FURTHER INFORMATION
CONTACT.

    Dated: March 24, 2021.
Michal Freedhoff,
Acting Assistant Administrator, Office of Chemical Safety and Pollution
Prevention.
[FR Doc. 2021-06495 Filed 4-2-21; 8:45 am]
BILLING CODE 6560-50-P


Note that the soil treatment standards supersede the historic presumption that an LDR treatment variance is appropriate for contaminated soil. LDR treatment variances are still available for contaminated soil, provided the generator can show that an otherwise applicable treatment standard (i. e., the soil treatment standard) is unachieveable or inappropriate, as discussed above, or can show that a site specific, risk based treatment variance is proper, as discussed below.

Site Specific, Risk Based LDR Treatment Variance for Contaminated Soils. On May 26, 1998, EPA promulgated a new land disposal restriction treatment variance specific to contaminated soil. Under 40 CFR 268.44( h)( 3), variances from otherwise applicable LDR treatment standards may be approved if it is determined that compliance with the treatment standards would result in treatment beyond the point at which short and long term threats to human health and the environment are minimized. This allows a site specific, risk based determination to supersede the technology based LDR treatment standards under certain circumstances.

Alternative land disposal restriction treatment standards established through site specific, risk based minimize threat variances should be within the range of values the Agency generally finds acceptable for risk based cleanup levels. That is, for carcinogens, alternative treatment standards should ensure constituent concentrations that result in the total excess risk to an individual exposed over a lifetime generally falling within a range from 10 4 to 10 6 , using 10 6 as a point of departure and with a preference for achieving the more protective end of the risk range. For non carcinogenic effects, alternative treatment standards should ensure constituent concentrations that an individual could be exposed to on a daily basis without appreciable risk of deleterious effect during a lifetime; in general, the hazard index should not exceed one (1). Constituent concentrations that achieve these levels should be calculated based on a reasonable maximum exposure scenario  that is, based on an analysis of both the current and reasonable expected future land uses, with exposure parameters chosen based on a reasonable assessment of the maximum exposure that might occur; however, alternative LDR treatment standards may not be based on consideration of post land disposal controls such as caps or other barriers.

See, regulations at 40 CFR 268.44( h)( 4), promulgated May 26, 1998 and associated preamble discussion at 63 FR 28606 28608.

Regulations and Policies that Apply Only to Debris 13 LDR Treatment Standards for Contaminated Debris. In 1992, EPA established land disposal restriction treatment standards specific to hazardous contaminated debris. The debrisspecific treatment standards established by these regulations are based on application of common extraction, destruction, and containment debris treatment technologies and are expressed as specific technologies rather than numeric criteria. As with the contaminated soil treatment standards discussed earlier, generators of hazardous contaminated debris may choose between meeting either the debris treatment standards or the numerical treatment standard promulgated for the contaminating hazardous waste. See, regulations at 40 CFR 268.45, promulgated August 18, 1992, and associated preamble discussion at 57 FR 37194 and 27221.

Interpretation that Debris Treated to the LDR Debris Treatment Standards Using Extraction or Destruction Technologies no Longer Contain Hazardous Waste. With the land disposal restriction treatment standards for hazardous contaminated debris, in 1992, EPA determined that hazardous debris treated to comply with the debris treatment standards using one of the identified extraction or destruction technologies would be considered no longer to contain hazardous waste and would, therefore, no longer be subject to regulation under RCRA, provided the debris do not exhibit any of the hazardous waste characteristics. This "contained in determination" is automatic; no agency action is needed. Note that this automatic contained in determination does not apply to debris treated to the debris treatment standards using one of the identified immobilization technologies. See, regulations at 40 CFR 261.3( f) and treatment standards at Table 1 of 40 CFR 268.45, promulgated August 18, 1992, and associated preamble discussion at 51 FR 37225.

cc: Barbara Simcoe, Association of State and Territorial Solid Waste Management Officials APPENDIX B: STATISTICAL TABLES Table B 1: 10% Values For The Nonparametric Test of Location nU ( nT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 1 9 10 11 12 13 14 15 16 17 18 19 19 20 21 22 23 24 25 26 27 28 28 29 30 31 32 33 34 35 36 37 37 38 39 40 41 42 43 44 45 46 46 2 3 4 5 6 6 7 8 8 9 10 10 11 12 12 13 14 15 15 16 17 17 18 19 19 20 21 21 22 23 23 24 25 25 26 27 28 28 29 30 30 31 32 32 33 34 34 35 36 3 2 3 4 4 5 5 6 6 7 7 8 9 9 10 10 11 11 12 12 13 13 14 14 15 15 16 17 17 18 18 19 19 20 20 21 21 22 22 23 24 24 25 25 26 26 27 27 28 28 4 2 3 3 4 4 5 5 5 6 6 7 7 8 8 9 9 9 10 10 11 11 12 12 13 13 13 14 14 15 15 16 16 16 17 17 18 18 19 19 20 20 20 21 21 22 22 23 23 23 5 2 3 3 3 4 4 4 5 5 6 6 6 7 7 7 8 8 9 9 9 10 10 10 11 11 12 12 12 13 13 13 14 14 14 15 15 16 16 16 17 17 17 18 18 19 19 19 20 20 6 2 2 3 3 3 4 4 4 5 5 5 6 6 6 7 7 7 8 8 8 9 9 9 10 10 10 11 11 11 11 12 12 12 13 13 13 14 14 14 15 15 15 16 16 16 17 17 17 18 7 2 2 3 3 3 3 4 4 4 5 5 5 5 6 6 6 7 7 7 7 8 8 8 9 9 9 9 10 10 10 11 11 11 11 12 12 12 13 13 13 13 14 14 14 14 15 15 15 16 8 2 2 2 3 3 3 4 4 4 4 5 5 5 5 6 6 6 6 7 7 7 7 8 8 8 8 9 9 9 9 10 10 10 10 11 11 11 11 12 12 12 12 13 13 13 13 14 14 14 9 1 2 2 2 3 3 3 3 4 4 4 4 4 5 5 5 5 6 6 6 6 7 7 7 7 7 8 8 8 8 9 9 9 9 9 10 10 10 10 11 11 11 11 12 12 12 12 12 13 13 10 1 2 2 2 2 3 3 3 3 4 4 4 4 4 5 5 5 5 5 6 6 6 6 7 7 7 7 7 8 8 8 8 8 9 9 9 9 9 10 10 10 10 10 11 11 11 11 11 12 12 11 1 2 2 2 2 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 8 8 8 8 8 9 9 9 9 9 10 10 10 10 10 10 11 11 11 12 1 2 2 2 2 2 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 9 10 10 10 10 10 13 1 2 2 2 2 2 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 9 10 10 14 1 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 7 8 8 8 8 8 8 9 9 9 9 9 15 1 2 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 5 6 6 6 6 6 6 6 7 7 7 7 7 7 7 8 8 8 8 8 8 8 9 9 16 1 2 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 8 8 8 8 8 8 17 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 8 8 8 8 18 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 8 19 1 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 7 7 7 7 7 7 7 20 1 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 7 7 7 7 7 21 1 1 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 6 7 7 7 22 1 1 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 6 7 23 1 1 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 24 1 1 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 25 1 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 26 1 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 6 6 6 6 27 1 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 6 6 28 1 1 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 6 29 1 1 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 30 1 1 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 31 1 1 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 32 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 33 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 34 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 35 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 36 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 37 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 38 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 39 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 40 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 41 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 42 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 43 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 44 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 45 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 46 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 47 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 48 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 49 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 50 1 1 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 Table B 2: 5% Values For The Nonparametric Test of Location nU ( nT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 1 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 39 40 41 42 43 44 45 46 47 48 49 2 5 6 7 8 9 9 10 11 12 13 13 14 15 16 16 17 18 19 20 20 21 22 23 23 24 25 26 26 27 28 29 30 30 31 32 33 33 34 35 36 37 37 38 39 40 40 3 3 4 5 5 6 7 7 8 9 9 10 11 11 12 12 13 14 14 15 16 16 17 18 18 19 19 20 21 21 22 23 23 24 24 25 26 26 27 28 28 29 30 30 31 31 32 33 33 4 3 4 4 5 5 6 6 7 8 8 9 9 10 10 11 11 12 12 13 13 14 14 15 15 16 17 17 18 18 19 19 20 20 21 21 22 22 23 23 24 24 25 26 26 27 27 28 28 5 2 3 3 4 4 5 5 6 6 7 7 8 8 9 9 9 10 10 11 11 12 12 13 13 14 14 14 15 15 16 16 17 17 18 18 18 19 19 20 20 21 21 22 22 23 23 23 24 24 6 2 3 3 4 4 4 5 5 6 6 6 7 7 8 8 8 9 9 10 10 10 11 11 12 12 12 13 13 14 14 14 15 15 16 16 16 17 17 18 18 18 19 19 20 20 20 21 21 21 7 2 3 3 3 4 4 5 5 5 6 6 6 7 7 7 8 8 8 9 9 9 10 10 11 11 11 12 12 12 13 13 13 14 14 14 15 15 15 16 16 16 17 17 18 18 18 19 19 19 8 2 3 3 3 4 4 4 5 5 5 6 6 6 6 7 7 7 8 8 8 9 9 9 10 10 10 11 11 11 12 12 12 12 13 13 13 14 14 14 15 15 15 16 16 16 17 17 17 17 9 2 2 3 3 3 4 4 4 5 5 5 5 6 6 6 7 7 7 7 8 8 8 9 9 9 9 10 10 10 11 11 11 11 12 12 12 13 13 13 13 14 14 14 15 15 15 15 16 16 10 2 2 3 3 3 4 4 4 4 5 5 5 5 6 6 6 6 7 7 7 8 8 8 8 9 9 9 9 10 10 10 10 11 11 11 11 12 12 12 12 13 13 13 14 14 14 14 15 15 11 2 2 3 3 3 3 4 4 4 4 5 5 5 5 6 6 6 6 7 7 7 7 8 8 8 8 9 9 9 9 9 10 10 10 10 11 11 11 11 12 12 12 12 13 13 13 13 14 14 12 2 2 3 3 3 3 3 4 4 4 4 5 5 5 5 6 6 6 6 6 7 7 7 7 8 8 8 8 8 9 9 9 9 10 10 10 10 10 11 11 11 11 12 12 12 12 12 13 13 13 2 2 2 3 3 3 3 4 4 4 4 4 5 5 5 5 6 6 6 6 6 7 7 7 7 7 8 8 8 8 8 9 9 9 9 9 10 10 10 10 11 11 11 11 11 12 12 12 12 14 2 2 2 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 6 6 6 6 6 7 7 7 7 7 8 8 8 8 8 9 9 9 9 9 10 10 10 10 10 11 11 11 11 11 12 15 2 2 2 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 9 9 9 9 9 9 10 10 10 10 10 11 11 11 16 2 2 2 2 3 3 3 3 3 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 9 9 9 9 9 9 10 10 10 10 10 10 17 2 2 2 2 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 8 8 9 9 9 9 9 9 10 10 10 18 2 2 2 2 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 8 8 8 8 8 8 8 9 9 9 9 9 9 10 19 1 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 5 5 5 5 5 5 5 6 6 6 6 6 6 7 7 7 7 7 7 7 8 8 8 8 8 8 8 9 9 9 9 9 20 1 2 2 2 2 2 3 3 3 3 3 3 4 4 4 4 4 4 4 5 5 5 5 5 5 5 6 6 6 6 6 6 6 7 7 7 7 7 7 7 8 8 8 8 8 8 8 9 9 9 21 1 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 4 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 7 7 7 7 7 7 7 8 8 8 8 8 8 8 9 22 1 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 8 8 8 8 8 8 23 1 2 2 2 2 2 2 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 8 8 8 8 24 1 2 2 2 2 2 2 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 7 8 8 25 1 2 2 2 2 2 2 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 8 26 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 7 7 7 7 7 7 7 7 27 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 6 7 7 7 7 7 7 28 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 7 7 7 7 7 29 1 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 6 7 7 7 30 1 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 6 7 7 31 1 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 6 6 32 1 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 6 33 1 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 6 34 1 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 6 35 1 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 6 36 1 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 6 6 6 6 6 37 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 5 6 6 6 38 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 5 6 6 39 1 1 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 5 6 40 1 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 5 41 1 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 5 42 1 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 5 43 1 1 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 44 1 1 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 5 45 1 1 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 5 46 1 1 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 5 47 1 1 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 5 48 1 1 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 5 49 1 1 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 5 50 1 1 2 2 2 2 2 2 2 2 2 2 2 2 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 3 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 4 5 5 5 5 Table B 3. Critical Values of Student's t Distribution (One Tailed)

Degrees of Freedom 1 " 0.80 0.85 0.90 0.95 0.99 1 1.376 1.963 3.078 6.314 31.821 2 1.061 1.386 1.886 2.920 6.965 3 0.978 1.250 1.638 2.353 4.541 4 0.941 1.190 1.533 2.132 3.747 5 0.920 1.156 1.476 2.015 3.365 6 0.906 1.134 1.440 1.943 3.143 7 0.896 1.119 1.415 1.895 2.998 8 0.889 1.108 1.397 1.860 2.896 9 0.883 1.100 1.383 1.833 2.821 10 0.879 1.093 1.372 1.812 2.764 11 0.876 1.088 1.363 1.796 2.718 12 0.873 1.083 1.356 1.782 2.681 13 0.870 1.079 1.350 1.771 2.650 14 0.868 1.076 1.345 1.761 2.624 15 0.866 1.074 1.340 1.753 2.602 16 0.865 1.071 1.337 1.746 2.583 17 0.863 1.069 1.333 1.740 2.567 18 0.862 1.067 1.330 1.734 2.552 19 0.861 1.066 1.328 1.729 2.539 20 0.860 1.064 1.325 1.725 2.528 21 0.859 1.063 1.323 1.721 2.518 22 0.858 1.061 1.321 1.717 2.508 23 0.858 1.060 1.319 1.714 2.500 24 0.857 1.059 1.318 1.711 2.492 25 0.856 1.058 1.316 1.708 2.485 26 0.856 1.058 1.315 1.706 2.479 27 0.855 1.057 1.314 1.703 2.473 28 0.855 1.056 1.313 1.701 2.467 29 0.854 1.055 1.311 1.699 2.462 30 0.854 1.055 1.310 1.697 2.457 40 0.851 1.050 1.303 1.684 2.423 60 0.848 1.046 1.296 1.671 2.390 120 0.845 1.041 1.289 1.658 2.358 ¥ 0.842 1.036 1.282 1.645 2.326 Table B 4. Critical Values For the Wilcoxon Rank Sum Test nT a nref 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 2 0.05 0.10 0 0 0 1 0 1 1 2 1 2 1 2 2 3 2 3 2 4 2 4 3 5 3 5 4 5 4 6 4 6 4 7 5 7 5 8 5 8 3 0.05 0.10 0 1 1 2 2 2 2 3 3 4 3 5 4 6 5 6 5 7 6 8 6 9 7 10 8 11 8 11 9 12 10 13 10 14 11 15 12 16 4 0.05 0.10 0 1 1 2 2 4 3 5 4 6 5 7 6 8 7 10 8 11 9 12 10 13 11 14 12 16 13 17 15 18 16 19 17 21 18 22 19 23 5 0.05 0.10 1 2 2 3 3 5 5 6 6 8 7 9 9 11 10 13 12 14 13 16 14 18 16 19 17 21 19 23 20 24 21 26 23 28 24 29 26 31 6 0.05 0.10 1 2 3 4 4 6 6 8 8 10 9 12 11 14 13 16 15 18 17 20 18 22 20 24 22 26 24 28 26 30 27 32 29 35 31 37 33 39 7 0.05 0.10 1 2 3 5 5 7 7 9 9 12 12 14 14 17 16 19 18 22 20 24 22 27 25 29 27 32 29 34 31 37 34 39 36 42 38 44 40 47 8 0.05 0.10 2 3 4 6 6 8 9 11 11 14 14 17 16 20 19 23 21 25 24 28 27 31 29 34 32 37 34 40 37 43 40 46 42 49 45 52 48 55 9 0.05 0.10 2 3 5 6 7 10 10 13 13 16 16 19 19 23 22 26 25 29 28 32 31 36 34 39 37 42 40 46 43 49 46 53 49 56 52 59 55 63 10 0.05 0.10 2 4 5 7 8 11 12 14 15 18 18 22 21 25 25 29 28 33 32 37 35 40 38 44 42 48 45 52 49 55 52 59 56 63 59 67 63 71 11 0.05 0.10 2 4 6 8 9 12 13 16 17 20 20 24 24 28 28 32 32 37 35 41 39 45 43 49 47 53 51 58 55 62 58 66 62 70 66 74 70 79 12 0.05 0.10 3 5 6 9 10 13 14 18 18 22 22 27 27 31 31 36 35 40 39 45 43 50 48 54 52 59 56 64 61 68 65 73 69 78 73 82 78 87 13 0.05 0.10 3 5 7 10 11 14 16 19 20 24 25 29 29 34 34 39 38 44 43 49 48 54 52 59 57 64 62 69 66 75 71 80 76 85 81 90 85 95 14 0.05 0.10 4 5 8 11 12 16 17 21 22 26 27 32 32 37 37 42 42 48 47 53 52 59 57 64 62 70 67 75 72 81 78 86 83 92 88 98 93 103 15 0.05 0.10 4 6 8 11 13 17 19 23 24 28 29 34 34 40 40 46 45 52 51 58 56 64 62 69 67 75 73 81 78 87 84 93 89 99 95 105 101 111 Table B 4. Critical Values For the Wilcoxon Rank Sum Test (continued)

nT a nref 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 16 0.05 0.10 4 6 9 12 15 18 20 24 26 30 31 37 37 43 43 49 49 55 55 62 61 68 66 75 72 81 78 87 84 94 90 100 96 107 102 113 108 120 17 0.05 0.10 4 7 10 13 16 19 21 26 27 32 34 39 40 46 46 53 52 59 58 66 65 73 71 80 78 86 84 93 90 100 97 107 103 114 110 121 116 128 18 0.05 0.10 5 7 10 14 17 21 23 28 29 35 36 42 42 49 49 56 56 63 62 70 69 78 76 85 83 92 89 99 96 107 103 114 110 121 117 129 124 136 19 0.05 0.10 5 8 11 15 18 22 24 29 31 37 38 44 45 52 52 59 59 67 66 74 73 82 81 90 88 98 95 105 102 113 110 121 117 129 124 136 131 144 20 0.05 0.10 5 8 12 16 19 23 26 31 33 39 40 47 48 55 55 63 63 71 70 79 78 87 85 95 93 103 101 111 108 120 116 128 124 136 131 144 139 152


[Federal Register Volume 82, Number 122 (Tuesday, June 27, 2017)]
[Notices]
[Pages 29073-29074]
[FR Doc No: 2017-13385]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application for Transfer of Licenses and Soliciting
Comments and Motions To Intervene

STS Hydropower Ltd.
STS Hydropower, LLC
    Project Nos. 2411-027, 2446-049, 3819-011, 7120-063, 7242-059, and
9951-054
    On May 19, 2017, STS Hydropower Ltd. (transferor) and STS
Hydropower, LLC (transferee) filed an application for transfer of
licenses for the following projects.

------------------------------------------------------------------------
           Project No.               Project names         Locations
------------------------------------------------------------------------
P-2411-027......................  Schoolfield         Dan River,
                                   Project.            Pittsylvania
                                                       County, VA.
P-2446-049......................  Dixon Project.....  Rock River, Lee
                                                       County, IL.
P-3819-011......................  Mt. Elbert Water    Mt. Elbert
                                   Power Project.      Conduit, Lake
                                                       County, CO.
P-7120-063......................  Kekawaka Creek      Kekawaka Creek,
                                   Project.            tributary to the
                                                       Eel River,
                                                       Trinity and
                                                       Humboldt
                                                       counties, CA.
P-7242-059......................  Kanaka Project....  Sucker Run Creek,
                                                       tributary of the
                                                       South Fork
                                                       Feather River,
                                                       Butte County, CA.
P-9951-054......................  French Landing      Huron River, Wayne
                                   Hydro Water Power   County, MI.
                                   Project.
------------------------------------------------------------------------

    The transferor and transferee seek Commission approval to transfer
the licenses for the above mentioned projects from the transferor to
the transferee.
    Applicant Contacts: For Transferor and Transferee: Mr. Bernard
Cherry, Eagle Creek Renewable Energy, LLC, 65 Madison Avenue,
Morristown, NJ 07960, Phone:<PHONE_NUMBER>, email:
<EMAIL_ADDRESS>and Mr. Donald H. Clarke and Mr. Joshua E.
Adrian, Duncan, Weinberg, Genzer & Pembroke, P.C., 1615 M Street NW.,
Washington, DC 20036, Phone:<PHONE_NUMBER>, Emails<EMAIL_ADDRESS>and
<EMAIL_ADDRESS>    FERC Contact: Patricia W. Gillis,<PHONE_NUMBER>.
    Deadline for filing comments and motions to intervene: 30 days from
the issuance date of this notice, by the Commission. The Commission
strongly encourages electronic filing. Please file motions to intervene
and comments using the Commission's eFiling system at http://www.ferc.gov/docs-filing/efiling.asp. Commenters can submit brief
comments up to 6,000 characters, without prior registration, using the
eComment system at http://www.ferc.gov/docs-filing/ecomment.asp. You
must include your

name and contact information at the end of your comments. For
assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>(866) 208-3676 (toll free), or (202) 502-
8659 (TTY). In lieu of electronic filing, please send a paper copy to:
Secretary, Federal Energy Regulatory Commission, 888 First Street NE.,
Washington, DC 20426. The first page of any filing should include
docket number(s) P-2411-027, P-2446-049, P-3819-011, P-7120-063, P-
7242-059, or P-9951-054.

    Dated: June 21, 2017.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2017-13385 Filed 6-26-17; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 226 (Monday, November 29, 2021)]
[Rules and Regulations]
[Pages 67651-67654]
[FR Doc No: 2021-25958]

=======================================================================
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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2021-0870]
RIN 1625-AA00

Safety Zone; Patapsco River, Baltimore, MD

AGENCY: Coast Guard, Department of Homeland Security (DHS).

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain waters of the Patapsco River. This action is necessary to
provide for the safety of life on these navigable waters near the
Francis Scott Key (I-695) Bridge, Baltimore, MD, while work crews
install power transmission lines crossing over the Patapsco River on

December 3, 2021, and on December 4, 2021 (alternate dates December 6,
2021, and on December 7, 2021). This regulation prohibits persons and
vessels from being in the safety zone unless authorized by the Captain
of the Port, Maryland-National Capital Region or a designated
representative.

DATES: This rule is effective from 9 a.m. on December 3, 2021, to 3:30
p.m. on December 7, 2021.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2021-0870 in the ``SEARCH'' box and click ``SEARCH.'' Next, in the
Document Type column, select ``Supporting & Related Material.''

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Ron Houck, Sector Maryland-National Capital Region
Waterways Management Division, U.S. Coast Guard; telephone 410-576-
2674, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On November 17, 2021, Baltimore Gas and Electric Company (BGE)
notified the Coast Guard that it will be conducting activities
associated with the installation of new overhead power transmission
lines crossing over the Patapsco River from the vicinity of the Hawkins
Point terminal Station on the west side of the Patapsco River to a
location just north of Sollers Point Terminal Station on the east side
of the Patapsco River, from 9 a.m. to 11:30 a.m. and from 1 p.m. to
3:30 p.m. on December 3, 2021, and during the same times on December 4,
2021. If necessary due to inclement weather or other reason on December
3, 2021, it will be enforced from 9 a.m. to 11:30 a.m. and from 1 p.m.
to 3:30 p.m. on December 6, 2021. If necessary due to inclement weather
or other reason on December 4, 2021, it will be enforced from 9 a.m. to
11:30 a.m. and from 1 p.m. to 3:30 p.m. on December 7, 2021. This
installation process requires the temporary closure of the navigation
channel near the Francis Scott Key (I-695) Bridge and the temporary
closure of other portions of the Patapsco River nearby.
    The Coast Guard is issuing this temporary rule without prior notice
and opportunity to comment pursuant to authority under section 4(a) of
the Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This
provision authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because it is impracticable and contrary to
public interest to delay the effective date of this rule. Immediate
action is needed to respond to the potential safety hazards associated
with the installation of new overhead power transmission lines crossing
over the Patapsco River within the navigation channel near the Francis
Scott Key (I-695) Bridge and other portions of the Patapsco River
nearby. The Coast Guard was unable to publish a NPRM due to the short
time period between project planners notifying the Coast Guard of the
work and publication of this safety zone. It is impracticable and
contrary to the public interest to publish an NPRM because we must
establish this safety zone by December 3, 2021.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be impracticable and contrary to the public interest
because immediate action is needed to respond to the potential safety
hazards associated with the installation of power transmission lines
over the Patapsco River adjacent to Francis Scott Key (I-695) Bridge
conducted within the federal navigation channel and other portions of
the river nearby. Such hazards include low-hanging or falling ropes and
cables, helicopter rotor downwash and noise, dangerous projectiles, and
or other debris.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034 (previously 33 U.S.C. 1231). The COTP Maryland-National Capital
Region has determined that potential hazards associated with the
overhead power transmission line installation work will be a safety
concern for anyone transiting the Patapsco River. This rule is needed
to ensure the safety of vessels and the navigable waters in the safety
zone before, during, and after the scheduled work.

IV. Discussion of the Rule

    This rule establishes a safety zone from 9 a.m. on December 3,
2021, to 3:30 p.m. on December 7, 2021. The safety zone will be
enforced from 9 a.m. to 11:30 a.m. and from 1 p.m. to 3:30 p.m. on
December 3, 2021, and during the same times on December 4, 2021. If
necessary due to inclement weather or other reason on December 3, 2021,
it will be enforced from 9 a.m. to 11:30 a.m. and from 1 p.m. to 3:30
p.m. on December 6, 2021. If necessary due to inclement weather or
other reason on December 4, 2021, it will be enforced from 9 a.m. to
11:30 a.m. and from 1 p.m. to 3:30 p.m. on December 7, 2021. The safety
zone will cover all navigable waters of the Patapsco River, encompassed
by a line connecting the following points beginning at the shoreline at
Thoms Cove at position latitude 39[deg]12'36'' N, longitude
076[deg]32'50'' W, thence east and south along the shoreline to Hawkins
Point at latitude 39[deg]12'40'' N, longitude 076[deg]31'58'' W, thence
northeast across the Patapsco River to Coffin Point at latitude
39[deg]13'55'' N, longitude 076[deg]30'18'' W, thence west and north
along the shoreline to Sollers Point at latitude 39[deg]14'01'' N,
longitude 076[deg]30'59'' W, thence west across the Patapsco River to
and terminating at the point of origin, located at Baltimore, MD.
    The duration of the rule and enforcement of the zone is intended to
ensure the safety of vessels and these navigable waters while the
activities associated with the installation of new overhead power
transmission lines crossing over the Patapsco River are being
conducted. The COTP will notify the public that the safety zone will be
enforced by all appropriate means to the affected segments of the
public, as practicable, in accordance with 33 CFR 165.7(a). Such means
of notification may also include, but are not limited to, Broadcast
Notice to Mariners. Vessels or persons violating this rule are subject
to the penalties set forth in 46 U.S.C. 70036 (previously codified in
33 U.S.C. 1232) and 46 U.S.C. 70052 (previously codified in 50 U.S.C.
192).
    Except for craft and equipment operated by BGE, or its
subcontractors, no vessel or person will be permitted to enter the
safety zone without obtaining permission from the COTP or a designated
representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses

based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action'' under Executive Order 12866. Accordingly, this rule
has not been reviewed by the Office of Management and Budget (OMB).
    This regulatory action determination is based on the size,
duration, day-of-week, and time of year of the safety zone. Vessels or
persons will not be allowed to enter or transit a portion of the
Patapsco River for a total 10 enforcement-hours. Due to the nature of
the work and the hazards it presents to the workers and the public, the
COTP has identified the need to close the Patapsco River in the
vicinity of the overhead power line crossing while this work is
ongoing. Moreover, the Coast Guard will issue Broadcast Notice to
Mariners via VHF-FM marine channel 16 about the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting only 10 total enforcement hours that will prohibit
entry within certain navigable waters of the Patapsco River. It is
categorically excluded from further review under paragraph L60(c) of
Appendix A, Table 1 of DHS Instruction Manual 023-01-001-01, Rev. 1.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to call or email the person listed in the FOR
FURTHER INFORMATION CONTACT section to coordinate protest activities so
that your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.2.

0
2. Add Sec.  165.T05-0870 to read as follows:

Sec.  165.T05-0870  Safety Zone; Patapsco River, Baltimore, MD.

    (a) Location. The following area is a safety zone: All navigable
waters of the Patapsco River, encompassed by a line connecting the
following points beginning at the shoreline at Thoms Cove at position
latitude 39[deg]12'36'' N, longitude 076[deg]32'50'' W, thence east and
south along the shoreline to Hawkins Point at latitude 39[deg]12'40''
N, longitude 076[deg]31'58'' W, thence northeast across the Patapsco
River to Coffin Point at

latitude 39[deg]13'55'' N, longitude 076[deg]30'18'' W, thence west and
north along the shoreline to Sollers Point at latitude 39[deg]14'01''
N, longitude 076[deg]30'59'' W, thence west across the Patapsco River
to and terminating at the point of origin, located at Baltimore, MD.
These coordinates are based on datum NAD 83.
    (b) Definitions. As used in this section--
    Captain of the Port (COTP) means the Commander, U.S. Coast Guard
Sector Maryland-National Capital Region.
    Designated representative means a Coast Guard Patrol Commander,
including a Coast Guard coxswain, petty officer, or other officer
operating a Coast Guard vessel and a Federal, State, and local officer
designated by or assisting the Captain of the Port Maryland-National
Capital Region (COTP) in the enforcement of the safety zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by telephone at<PHONE_NUMBER> or on Marine Band Radio
VHF-FM channel 16 (156.8 MHz). Those in the safety zone must comply
with all lawful orders or directions given to them by the COTP or the
COTP's designated representative.
    (d) Enforcement officials. The U.S. Coast Guard may be assisted in
the patrol and enforcement of the safety zone by Federal, State, and
local agencies.
    (e) Enforcement periods. This section will be enforced:
    (1) From 9 a.m. to 11:30 a.m. and from 1 p.m. to 3:30 p.m. on
December 3, 2021. If necessary due to inclement weather or other reason
on December 3, 2021, it will be enforced from 9 a.m. to 11:30 a.m. and
from 1 p.m. to 3:30 p.m. on December 6, 2021.
    (2) From 9 a.m. to 11:30 a.m. and from 1 p.m. to 3:30 p.m. on
December 4, 2021. If necessary due to inclement weather or other reason
on December 4, 2021, it will be enforced from 9 a.m. to 11:30 a.m. and
from 1 p.m. to 3:30 p.m. on December 7, 2021.

    Dated: November 23, 2021.
David E. O'Connell,
Captain, U.S. Coast Guard, Captain of the Port Maryland-National
Capital Region.
[FR Doc. 2021-25958 Filed 11-26-21; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 88, Number 168 (Thursday, August 31, 2023)]
[Rules and Regulations]
[Page 60151]
[FR Doc No: 2023-18709]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2021-0406; FRL-10991-03-R4]

Air Plan Approval; North Carolina; Bulk Gasoline Plants,
Terminals Vapor Recovery Systems; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule; correction.

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SUMMARY: The Environmental Protection Agency (EPA) published a final
rule in the Federal Register on August 9, 2023, titled ``Air Plan
Approval; North Carolina; Bulk Gasoline Plants, Terminals Vapor
Recovery Systems.'' The document approved revisions to the North
Carolina State Implementation Plan (SIP) concerning changes to the
North Carolina Department of Environmental Quality's air regulations
regarding bulk gasoline terminals and plants, gasoline cargo tanks and
vapor collection systems, and leak tightness and vapor leak
requirements. EPA approved those changes pursuant to the Clean Air Act.
An error in the instructions amending the Code of Federal Regulations
(CFR) in the document is identified and corrected in this action. This
correction does not change any final action taken by EPA in the August
9, 2023, final rule.

DATES: Effective September 8, 2023.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2021-0406. All documents in the docket
are listed on the www.regulations.gov website. Although listed in the
index, some information may not be publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through www.regulations.gov or in hard
copy at the Air Regulatory Management Section, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. EPA requests that if at all possible, you contact the
person listed in the FOR FURTHER INFORMATION CONTACT section to
schedule your inspection. The Regional Office's official hours of
business are Monday through Friday 8:30 a.m. to 4:30 p.m., excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Sarah LaRocca, Air Planning and
Implementation Branch, Air and Radiation Division, U.S. Environmental
Protection Agency, Region 4, 61 Forsyth Street SW, Atlanta, Georgia
30303-8960. Ms. LaRocca can be reached via electronic mail at
[email protected] or via telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: EPA published a final rule in the Federal
Register on August 9, 2023 (88 FR 53795), titled ``Air Plan Approval;
North Carolina; Bulk Gasoline Plants, Terminals Vapor Recovery
Systems.'' The final rule approved changes to the following regulations
in North Carolina's SIP: 15A North Carolina Administrative Code,
Subchapter 02D, Rules .0926, Bulk Gasoline Plants; \1\ .0927, Bulk
Gasoline Terminals; \2\ .0932, Gasoline Cargo Tanks and Vapor
Collection Systems; and .2615, Determination of Leak Tightness and
Vapor Leaks. However, the Federal Register document contained an error
in the instructions regarding amendments to the table titled ``EPA-
Approved North Carolina Regulations'' found at 40 CFR 52.1770(c)(1).
See 88 FR 53797. In the instructions, EPA inadvertently referred to the
table entries to be amended as ``Section .0926,'' ``Section .0927,''
``Section .0932,'' and ``Section .2615'' instead of ``Rule .0926,''
``Rule .0927,'' ``Rule .0932,'' and ``Rule .2615'' and therefore
inadvertently sought to replace, rather than revise, those entries. EPA
is now correcting that error.
---------------------------------------------------------------------------

    \1\ In Paragraph (n) of Rule .0926, North Carolina's Rule
references Rule 02D .0960 which is not in the SIP. The Division of
Air Quality (DAQ) withdrew that reference in Paragraph (n) from the
April 13, 2021, SIP revision.
    \2\ Similar to the changes in Rule 02D .0926(n), Rule 02D
.0927(k) also references Rule 02D .0960 which is not in the SIP. DAQ
withdrew that reference in Paragraph (k) from the April 13, 2021,
SIP revision.
---------------------------------------------------------------------------

Correction

Sec.  52.1770  [Corrected]

0
In FR Doc. 2023-16564, published at 88 FR 53795 in the issue of August
9, 2023, on page 53797, in the third column, amendatory instruction 2
for Sec.  52.1770 is corrected to reads as follows:
    2. In Sec.  52.1770, amend the table in paragraph (c)(1) by
revising the entries ``Rule .0926,'' ``Rule .0927,'' ``Rule .0932,''
and ``Rule .2615'' to read as follows:

    Dated: August 25, 2023.
Carol Kemker,
Acting Regional Administrator, Region 4.
[FR Doc. 2023-18709 Filed 8-30-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 170 (Tuesday, September 7, 2021)]
[Notices]
[Pages 50113-50114]
[FR Doc No: 2021-19150]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-8883-01-OA]

Request for Nominations for the Science Advisory Board IRIS
Chloroform (Noncancer; Inhalation) Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office requests public nominations of scientific
experts to form a Panel to review the draft EPA Integrated Risk
Information System (IRIS) Toxicological Review of Chloroform
(Noncancer; Inhalation). The draft assessment includes a hazard
identification analysis, which summarizes the chemical properties,
pharmacokinetics, and health effects associated with environmental or
occupational exposure, and dose-response analysis, which characterizes
the quantitative relationship between chemical exposure and each
credible health hazard. The SAB Chloroform Review Panel will consider
whether the conclusions found in the EPA's draft assessment are clearly
presented and scientifically supported. The Panel will also be asked to
provide recommendations on how the assessment may be strengthened.

DATES: Nominations should be submitted by September 28, 2021 per the
instructions below.

FOR FURTHER INFORMATION CONTACT: Any member of the public wishing
further information regarding this Notice and Request for Nominations
may contact Dr. Suhair Shallal, Designated Federal Officer (DFO), EPA
Science Advisory Board via telephone/voice mail<PHONE_NUMBER>, or
email at<EMAIL_ADDRESS>General information concerning the EPA
SAB can be found at the EPA SAB website at https://sab.epa.gov.

SUPPLEMENTARY INFORMATION: Background: The SAB (42 U.S.C. 4365) is a
chartered Federal Advisory Committee that provides independent
scientific and technical peer review, advice, and recommendations to
the EPA Administrator on the technical basis for EPA actions. As a
Federal Advisory Committee, the SAB conducts business in accordance
with the Federal Advisory Committee Act (FACA) (5 U.S.C. App. 2) and
related regulations. The SAB Staff Office is forming an expert panel,
the SAB Chloroform Review Panel, under the auspices of the Chartered
SAB. The SAB Chloroform Review Panel will provide advice through the
chartered SAB. The SAB and the SAB Chloroform Review Panel will comply
with the provisions of FACA and all appropriate SAB Staff Office
procedural policies.
    The SAB Chloroform Review Panel will conduct a review of the draft
EPA IRIS Toxicological Review of Chloroform (Inhalation; Noncancer).
The draft assessment includes a hazard identification analysis, which
summarizes the chemical properties, pharmacokinetics, and health
effects associated with environmental or occupational exposure, and
dose-response analysis, which characterizes the quantitative
relationship between chemical exposure and each credible health hazard.
The SAB Chloroform Review Panel will consider whether the conclusions
found in the EPA's draft assessment are clearly presented and
scientifically supported. The Panel will also be asked to provide
recommendations on how the assessment may be strengthened.
    Request for Nominations: The SAB Staff Office is seeking
nominations of nationally and internationally recognized scientists
with demonstrated expertise in the following disciplines: toxicology,
specifically inhalation toxicology/dosimetry, hepatic and nephrological
toxicology; epidemiology; systematic review; physiologically-based
pharmacokinetic (PBPK) modeling; carcinogenesis; risk assessment; dose
response analysis.
    Process and Deadline for Submitting Nominations: Any interested
person or organization may nominate qualified

individuals in the areas of expertise described above for possible
service on the SAB Panel. Individuals may self-nominate. Nominations
should be submitted in electronic format (preferred) using the online
nomination form on the SAB website at https://sab.epa.gov (see the
``Public Input on Membership'' list under ``Committees, Panels, and
Membership''). To be considered, nominations should include the
information requested below. EPA values and welcomes diversity. All
qualified candidates are encouraged to apply regardless of sex, race,
disability, or ethnicity. Nominations should be submitted in time to
arrive no later than September 28, 2021. The following information
should be provided on the nomination form: Contact information for the
person making the nomination; contact information for the nominee; and
the disciplinary and specific areas of expertise of the nominee.
Nominees will be contacted by the SAB Staff Office and will be asked to
provide a recent curriculum vitae and a narrative biographical summary
that includes: Current position, educational background; research
activities; sources of research funding for the last two years; and
recent service on other national advisory committees or national
professional organizations. Persons having questions about the
nomination procedures, or who are unable to submit nominations through
the SAB website, should contact the DFO at the contact information
noted above. The names and biosketches of qualified nominees identified
by respondents to this Federal Register notice, and additional experts
identified by the SAB Staff Office, will be posted in a List of
Candidates for the Panel on the SAB website at https://sab.epa.gov.
Public comments on the List of Candidates will be accepted for 21 days.
The public will be requested to provide relevant information or other
documentation on nominees that the SAB Staff Office should consider in
evaluating candidates.
    For the EPA SAB Staff Office a balanced review panel includes
candidates who possess the necessary domains of knowledge, the relevant
scientific perspectives (which, among other factors, can be influenced
by work history and affiliation), and the collective breadth of
experience to adequately address the charge. In forming the expert
panel, the SAB Staff Office will consider public comments on the Lists
of Candidates, information provided by the candidates themselves, and
background information independently gathered by the SAB Staff Office.
Selection criteria to be used for panel membership include: (a)
Scientific and/or technical expertise, knowledge, and experience
(primary factors); (b) availability and willingness to serve; (c)
absence of financial conflicts of interest; (d) absence of an
appearance of a loss of impartiality; (e) skills working in committees,
subcommittees and advisory panels; and, (f) for the panel as a whole,
diversity of expertise and scientific points of view.
    The SAB Staff Office's evaluation of an absence of financial
conflicts of interest will include a review of the ``Confidential
Financial Disclosure Form for Environmental Protection Agency Special
Government Employees'' (EPA Form 3110-48). This confidential form is
required and allows government officials to determine whether there is
a statutory conflict between a person's public responsibilities (which
include membership on an EPA federal advisory committee) and private
interests and activities, or the appearance of a loss of impartiality,
as defined by federal regulation. The form may be viewed and downloaded
through the ``Ethics Requirements for Advisors'' link on the SAB
website at https://sab.epa.gov. This form should not be submitted as
part of a nomination.
    The approved policy under which the EPA SAB Office selects members
for subcommittees and review panels is described in the following
document: Overview of the Panel Formation Process at the Environmental
Protection Agency Science Advisory Board (EPA-SAB-EC-02-010), which is
posted on the SAB website at https://sab.epa.gov.

V. Khanna Johnston,
Deputy Director, Science Advisory Board Staff Office.
[FR Doc. 2021-19150 Filed 9-3-21; 8:45 am]
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