[Federal Register Volume 86, Number 96 (Thursday, May 20, 2021)]
[Notices]
[Pages 27443-27444]
[FR Doc No: 2021-10622]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1130]

Implanted Brain-Computer Interface Devices for Patients With
Paralysis or Amputation--Non-Clinical Testing and Clinical
Considerations; Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Implanted Brain-
Computer Interface (BCI) Devices for Patients with Paralysis or
Amputation--Non-Clinical Testing and Clinical Considerations.''
Implanted brain-computer interface (BCI) devices are neuroprostheses
that interface with the central or peripheral nervous system to restore
lost motor and/or sensory capabilities in patients with paralysis or
amputation. This guidance provides recommendations for nonclinical
testing and study design considerations for investigational device
exemptions feasibility and pivotal clinical studies.

DATES: The announcement of the guidance is published in the Federal
Register on May 20, 2021.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2014-N-1130 for ``Implanted Brain-Computer Interface(BCI) Devices
for Patients with Paralysis or Amputation--Non-clinical Testing and
Clinical Considerations.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Implanted Brain-Computer Interface (BCI) Devices for Patients with
Paralysis or Amputation--Non-clinical Testing and Clinical
Considerations'' to the Office of Policy, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
request.

FOR FURTHER INFORMATION CONTACT: Vivek Pinto, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4108, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The field of implanted BCI devices is progressing rapidly from
fundamental neuroscience discoveries to translational applications and
market access. Implanted BCI devices have the potential to bring
benefit to people with severe disabilities by increasing their ability
to interact with their environment, and consequently, providing new
independence in daily life. On November 21, 2014, the Center for
Devices and Radiological Health (CDRH) held an open public workshop
with the aim of fostering an open discussion on the scientific and
clinical considerations associated with the

development of implanted BCI devices. FDA considered the input provided
during this workshop to develop this guidance document. This guidance
document provides clinical study design and nonclinical testing
recommendations associated with BCI devices.
    This is a leapfrog guidance: A type of guidance that serves as a
mechanism by which the Agency can share initial thoughts regarding
emerging technologies that are likely to be of public health importance
early in product development. This leapfrog guidance represents the
Agency's initial thinking and our recommendations may change as more
information becomes available.
    A notice of availability of the draft guidance appeared in the
Federal Register of February 25, 2019 (84 FR 6007). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including the addition of a brief section on Human
Factors recommending that usability information be captured early in
device development and continue iteratively, and a recommendation in
the ``Home Use'' section, to describe the training related to home use
of the devices and how the effectiveness of this training will be
evaluated. A clarification was also added in the Scope section to
highlight that for any BCI devices with technological characteristics,
components, or indications for use or patient population not described
in the guidance, manufacturers/investigators should submit a pre-
submission to seek FDA feedback.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Implanted Brain-Computer Interface (BCI)
Devices for Patients with Paralysis or Amputation--Non-Clinical Testing
and Clinical Considerations.'' It does not establish any rights for any
person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``Implanted Brain-Computer Interface
(BCI) Devices for Patients with Paralysis or Amputation--Non-clinical
Testing and Clinical Considerations '' may send an email request to
<EMAIL_ADDRESS>to receive an electronic copy of the
document. Please use the document number 1500045 to identify the
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations and guidance have been
approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                            OMB control
      21 CFR part or guidance               Topic               No.
------------------------------------------------------------------------
812...............................  Investigational            0910-0078
                                     Device Exemption.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Q-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
801...............................  Medical Device             0910-0485
                                     Labeling
                                     Regulations.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
50, 56............................  Protection of Human        0910-0755
                                     Subjects: Informed
                                     Consent;
                                     Institutional
                                     Review Boards.
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    Dated: May 14, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-10622 Filed 5-19-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 78, Number 186 (Wednesday, September 25, 2013)]
[Rules and Regulations]
[Pages 58886-58890]
[FR Doc No: 2013-23371]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA-HQ-OPP-2012-0568; FRL-9396-1]

FD&C Blue No. 1; Exemption From the Requirement of a Tolerance

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: This regulation establishes an exemption from the requirement
of a tolerance for residues of FD&C Blue No. 1 (CAS Reg. No. 3844-45-9)
when used as an inert ingredient (dye) in pesticides formulation
applied to growing crops (seed treatment). Exponent on behalf of
Sensient Colors, LLC submitted a petition to EPA under the Federal
Food, Drug, and Cosmetic Act (FFDCA), requesting establishment of an
exemption from the requirement of a tolerance. This regulation
eliminates the need to establish a maximum permissible level for
residues of FD&C Blue No. 1.

DATES: This regulation is effective September 25, 2013. Objections and
requests for hearings must be received on or before November 25, 2013,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).

ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2012-0568, is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.

FOR FURTHER INFORMATION CONTACT: Lois Rossi, Registration Division
(7505P), Office of Pesticide Programs, Environmental Protection Agency,
1200 Pennsylvania Ave. NW., Washington, DC 20460-0001; telephone
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
     Crop production (NAICS code 111).
     Animal production (NAICS code 112).
     Food manufacturing (NAICS code 311).
     Pesticide manufacturing (NAICS code 32532).

B. How can I get electronic access to other related information?

    You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://www.ecfr.gov/cgi-bin/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.

C. How can I file an objection or hearing request?

    Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2012-0568 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
November 25, 2013. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
    In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any Confidential Business Information (CBI)) for
inclusion in the public docket. Information not marked confidential
pursuant to 40 CFR part 2 may be disclosed publicly by EPA without
prior notice. Submit the non-CBI copy of your objection or hearing
request, identified by docket ID number EPA-HQ-OPP-2012-0568, by one of
the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be CBI or other
information whose disclosure is restricted by statute.
     Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.

     Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.html.
    Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.

II. Petition for Exemption

    In the Federal Register of August 22, 2012 (77 FR 50661) (FRL-9358-
9), EPA issued a document pursuant to FFDCA section 408, 21 U.S.C.
346a, announcing the filing of a pesticide petition (PP 2E8004) by
Exponent (1150 Connecticut Ave. NW., Suite 1100, Washington, DC 20036)
on behalf of Sensient Colors, LLC (2515 N. Jefferson Ave., St. Louis,
MO 63106). The petition requested that 40 CFR 180.920 be amended by
establishing an exemption from the requirement of a tolerance for
residues of FD&C Blue No. 1 (CAS Reg. No. 3844-45-9) when used as an
inert ingredient (dye) in pesticide formulations applied to growing
crops (seed treatment). That document referenced a summary of the
petition prepared by Exponent on behalf of Sensient Colors, LLC, the
petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.

III. Inert Ingredient Definition

    Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.

IV. Aggregate Risk Assessment and Determination of Safety

    Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue * * *.''
    EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert in conjunction with possible exposure to residues of the inert
ingredient through food, drinking water, and through other exposures
that occur as a result of pesticide use in residential settings. If EPA
is able to determine that a finite tolerance is not necessary to ensure
that there is a reasonable certainty that no harm will result from
aggregate exposure to the inert ingredient, an exemption from the
requirement of a tolerance may be established.
    Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for FD&C Blue No. 1 including
exposure resulting from the exemption established by this action. EPA's
assessment of exposures and risks associated with FD&C Blue No. 1
follows.

A. Toxicological Profile

    EPA has evaluated the available toxicity data and considered their
validity, completeness, and reliability as well as the relationship of
the results of the studies to human risk. EPA has also considered
available information concerning the variability of the sensitivities
of major identifiable subgroups of consumers, including infants and
children. Specific information on the studies received and the nature
of the adverse effects caused by FD&C Blue No. 1 as well as the no-
observed-adverse-effect-level (NOAEL) and the lowest-observed-adverse-
effect-level (LOAEL) from the toxicity studies are discussed in this
unit. The chemical is also referred to as Brilliant Blue FCF in this
document, as this name is synonymous with FD&C Blue No. 1.
    FD&C Blue No. 1 is not acutely toxic via the oral route in rats and
via subcutaneous injection in mice. Long-term studies of the effects of
the color administered in the diet to dogs, rats and mice did not
indicate any significant toxic effects. In a chronic dog study,
treatment at doses up to 200 milligrams/kilogram bodyweight/day (mg/kg
bw/day) for a time period of 1 year did not show any treatment related
signs of toxicity or histological abnormalities. In a 2-year study,
rats fed a diet containing up to 2,000 mg/kg bw/day Brilliant Blue FCF
showed no evidence of treatment related effects. In a second long term
study in rats, Brilliant Blue FCF was fed as part of the diet for 75
weeks. No treatment related effects were found at 1,500 mg/kg bw/day,
the highest dose tested.
    Lifetime exposure of mice to Brilliant Blue FCF as part of the diet
did not result in consistent biologically significant, compound related
adverse effects on behavior, morbidity, mortality, hematology, general
physical observations or tumor incidence. The NOAEL for this study was
determined to be 7,354 mg/kg bw/day for male and 8,966 mg/kg bw/day for
female, the highest doses tested.
    Rats were treated with Brilliant Blue FCF in a chronic toxicity
study coupled with a reproductive study. The NOAEL was 1,072 mg/kg bw/
day for male rats and 631 mg/kg bw/day for females, based on a 15%
decrease in terminal mean body weight and decreased survival in high
dose females. In the reproductive portion of the study, there were no
compound related effects on fertility, gestation, parturition,
lactation, pup survival through weaning, or on number of live and
stillborn pups. The NOAEL was 1,073 mg/kg bw/day male rats and 1,318
mg/kg bw/day for females.
    Brilliant Blue FCF was fed to three successive generations of male
and female rats at dose levels up to 1,000 mg/kg bw/day. There were no
treatment related effects on adult mortality, mating, pregnancy and
fertility rates, lengths of gestation period, offspring survival or
sex, litter survival or

necropsy findings. The NOAEL for this study was 1,000 mg/kg bw/day, the
highest dose tested. Two additional reproductive studies in rats and
rabbits did not result fetal toxicity or anomalies at doses up to 2,000
mg/kg bw/day and 200 mg/kg bw day, respectively.
    Based on the results of the available genotoxicity studies, it was
concluded that Brilliant Blue FCF is not of concern with respect to
genotoxicity. A developmental neurotoxicity study also indicates that
there were no toxicological effects of concern. Immunotoxicity studies
were not available for review. However, signs of immunotoxicity were
not observed in any of the available studies conducted at doses above
the limit dose of 1,000 mg/kg/day. The metabolism of Brilliant Blue FCF
was determined in multiple studies. In three studies with rats that
were given Brilliant Blue FCF either via gavage or in the diet, the
major route of excretion was through the feces with total recoveries at
a minimum of 92% indicating very limited absorption via oral route of
exposure. The lack of gastrointestinal absorption and metabolism was
confirmed by studies in guinea pigs and mice.

B. Toxicological Points of Departure/Levels of Concern

    The available toxicity studies indicate that FD&C Blue No. 1 has a
very low overall toxicity. A NOAEL of 1,072 mg/kg bw/day for male rats
and 631 mg/kg bw/day for females can be derived from a chronic toxicity
study coupled with a reproductive study based on a 15% decrease in
terminal mean body weight and decreased survival in high dose females.
However, these results were not reproducible in several other chronic
longer duration studies at higher doses. Several long-term studies
indicate a higher NOAEL above the limit dose. Therefore, EPA concludes
that the existing database does not show a toxic endpoint of concern
for acute, chronic, and short- and intermediate-term risks, and,
accordingly, a quantitative risk assessment for FD&C Blue No. 1 is not
necessary.

C. Exposure Assessment

    1. Dietary exposure from food and feed uses. In evaluating dietary
exposure to FD&C Blue No. 1, EPA considered exposure under the proposed
exemption from the requirement of a tolerance. EPA assessed dietary
exposures from FD&C Blue No. 1 in food as follows: Dietary exposure to
FD&C Blue No. 1 can occur from eating food treated with pesticide
formulations containing this inert ingredient. Dietary exposure can
also occur from eating foods which contain FD&C Blue No. 1 as an
ingredient. It is widely used as an ingredient in food products such as
ice cream, bottled food coloring, icings, ice pops, dairy products,
sweets and drinks. However, since an endpoint of concern for risk
assessment was not identified, a quantitative dietary exposure
assessment for FD&C Blue No. 1 was not conducted.
    2. Dietary exposure from drinking water. Dietary exposure from
drinking water to FD&C Blue No. 1 can occur by drinking water that has
been contaminated by run-off from a pesticide treated area. Since an
endpoint for risk assessment was not identified, a quantitative dietary
exposure assessment from drinking water for FD&C Blue No. 1 was not
conducted.
    3. From non-dietary exposure. The term ``residential exposure'' is
used in this document to refer to non-occupational, non-dietary
exposure (e.g., lawn and garden pest control, indoor pest control,
termiticides, and flea and tick control on pets). The proposed use of
FD&C Blue No. 1 as a seed treatment/dye under 40 CFR 180.920 is not
expected to result in residential exposure to this chemical.
Residential exposure is possible based on other currently approved
inert uses of this chemical. However, since there are no toxicological
effects of concern identified, it is not necessary to conduct
assessments of residential (non-occupational) exposures and risks.
There are no dermal or inhalation toxicological endpoints of concern to
the Agency therefore quantitative assessments have not been conducted.
    4. Cumulative effects from substances with a common mechanism of
toxicity. Section 408(b)(2)(D)(v) of FFDCA requires that, when
considering whether to establish, modify, or revoke a tolerance, the
Agency consider ``available information'' concerning the cumulative
effects of a particular pesticide's residues and ``other substances
that have a common mechanism of toxicity.''
    EPA has not found FD&C Blue No. 1 to share a common mechanism of
toxicity with any other substances, and FD&C Blue No. 1 does not appear
to produce a toxic metabolite produced by other substances. For the
purposes of this tolerance action, therefore, EPA has assumed that FD&C
Blue No. 1 does not have a common mechanism of toxicity with other
substances. For information regarding EPA's efforts to determine which
chemicals have a common mechanism of toxicity and to evaluate the
cumulative effects of such chemicals, see EPA's Web site at http://www.epa.gov/pesticides/cumulative.

D. Safety Factor for Infants and Children

    Section 408(b)(2)(C) of FFDCA provides that EPA shall apply an
additional tenfold (10X) margin of safety for infants and children in
the case of threshold effects to account for prenatal and postnatal
toxicity and the completeness of the database on toxicity and exposure
unless EPA determines based on reliable data that a different margin of
safety will be safe for infants and children. This additional margin of
safety is commonly referred to as the FQPA Safety Factor (SF). In
applying this provision, EPA either retains the default value of 10X,
or uses a different additional safety factor when reliable data
available to EPA support the choice of a different factor.
    The available toxicity studies suggest low toxicity of FD&C Blue
No. 1. The toxicity database for FD&C Blue No. 1 contains an acute oral
toxicity study, sub-chronic and chronic toxicity studies, including
carcinogenicity, reproductive and developmental toxicity studies. No
reproductive or developmental toxicity was observed in the modified
reproduction study, 3-generation reproduction study and developmental
toxicity studies in rats and rabbits. The database also contains
mutagenicity studies, neurotoxicity data and metabolism data. There is
no indication, based upon the available data, that FD&C Blue No. 1 is a
neurotoxic or immunotoxic chemical or results in increased qualitative
or quantitative susceptibility in infants or children. Based on this
information, there is no concern, at this time, for increased
sensitivity to infants and children to this chemical when used as inert
ingredient in pesticides formulations. Due to the lack of toxicity of
FD&C No. 1, EPA did not use safety factors in qualitatively assessing
its risk, and, for the same reason, no additional safety factor is
needed for assessing risk to infants and children.

E. Aggregate Risks and Determination of Safety

    Taking into consideration all available information on FD&C Blue
No. 1, EPA has determined that there is a reasonable certainty that no
harm will result to the general population, or to infants and children,
from aggregate exposure to FD&C Blue No. 1 residues under reasonably
foreseeable circumstances. Therefore, the establishment of an exemption
from tolerance under 40 CFR 180.920 for residues of FD&C Blue No. 1
when used

as an inert ingredient (dye) in pesticide formulations applied to
growing crops (seed treatment) is safe under FFDCA section 408.

V. Other Considerations

A. Analytical Enforcement Methodology

    An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.

B. International Residue Limits

    In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nation Food
and Agriculture Organization/World Health Organization food standards
program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level.
    The Codex has not established a MRL for FD&C Blue No. 1.

VI. Conclusions

    Therefore, an exemption from the requirement of a tolerance is
established under 40 CFR 180.920 for FD&C Blue No. 1 (CAS Reg. No.
3844-45-9) when used as an inert ingredient (dye) in pesticide
formulations applied to growing crops (seed treatment).

VII. Statutory and Executive Order Reviews

    This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
    Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
    This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
    This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).

VIII. Congressional Review Act

    Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).

List of Subjects in 40 CFR Part 180

    Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.

    Dated: September 17, 2013.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.

    Therefore, 40 CFR chapter I is amended as follows:

PART 180--[AMENDED]

0
1. The authority citation for part 180 continues to read as follows:

    Authority:  21 U.S.C. 321(q), 346a and 371.

0
2. In Sec.  180.920, alphabetically add the following inert ingredient
to the table, after the entry for Europic chloride and before the entry
for FD&C Blue No. 1, methyl-polyethylene glycol derivative (CAS Reg.
No. 9079-34-9), to read as follows:

Sec.  180.920  Inert ingredients used pre-harvest; exemption from the
requirement of a tolerance.

* * * * *

----------------------------------------------------------------------------------------------------------------
           Inert ingredients                       Limits                                Uses
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
FD&C Blue No. 1 (CAS Reg. No. 3844-45-   For seed treatment use      Dye, coloring agent
 9).                                      only.

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2013-23371 Filed 9-24-13; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 81, Number 90 (Tuesday, May 10, 2016)]
[Notices]
[Pages 28923-28924]
[FR Doc No: 2016-10888]

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SECURITIES AND EXCHANGE COMMISSION

[SEC File No. 270-389, OMB Control No. 3235-0444]

Submission for OMB Review; Comment Request

Upon Written Request, Copies Available From: Securities and Exchange
Commission, Office of FOIA Services, 100 F Street NE., Washington, DC
20549-2736.

Extension:
    Rule 10b-10.

    Notice is hereby given that, pursuant to the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501 et seq.) (``PRA''), the Securities and
Exchange Commission (``Commission'') has submitted to the Office of
Management and Budget (``OMB'') a request for approval of extension of
the previously approved collection of information provided for in Rule
10b-10 (17 CFR 240.10b-10) under the Securities and Exchange Act of
1934 (15 U.S.C. 78a et seq.).
    Rule 10b-10 requires broker-dealers to convey specified information
to customers regarding their securities transactions. This information
includes the date and time of the transaction, the identity and number
of shares bought or sold, and whether the broker-dealer acts as agent
for the customer or as principal for its own account. Depending on
whether the broker-dealer acts as agent or principal, Rule 10b-10
requires the disclosure of commissions, as well as mark-up and mark-
down information. For transactions in debt securities, Rule 10b-10
requires the disclosure of redemption and yield information. Rule 10b-
10 potentially applies to all of the approximately 4,183 firms
registered with the Commission that effect transactions for or with
customers.
    Based on information provided by registered broker-dealers to the
Commission in FOCUS Reports, the Commission staff estimates that on
average, registered broker-dealers process approximately 1,383,492,184
order tickets per month for transactions for or with customers. Each
order ticket representing a transaction effected for or with a customer
results in one confirmation. Therefore, the Commission staff estimates
that approximately 16,601,906,208 confirmations are sent to customers
annually. The confirmations required by Rule 10b-10 are generally
processed through automated systems. It takes approximately 30 seconds
to generate and send a confirmation. Accordingly, the Commission staff
estimates that broker-dealers spend approximately 138,349,218 hours per
year complying with Rule 10b-10.
    The amount of confirmations sent and the cost of sending each
confirmation varies from firm to firm. Smaller firms generally send
fewer confirmations than larger firms because they effect fewer
transactions. The Commission staff estimates the costs of producing and
sending a paper confirmation, including postage, to be approximately 57
cents. The Commission staff also estimates that the cost of producing
and sending a wholly electronic confirmation is approximately 39 cents.
Based on informal discussions with industry participants, as well as
representations made in requests for exemptive and no-action letters
relating to Rule 10b-10, the staff estimates that broker-dealers used
electronic confirmations for approximately 35 percent of transactions.
Based on these calculations, Commission staff estimates that
10,791,239, 035 paper confirmations are mailed each year at a cost of
$6,151,006,250. Commission staff also estimates that 5,810,667,173
wholly electronic confirmations are sent each year at a cost of
$2,266,160,197. Accordingly, Commission staff estimates that the total
annual cost associated with generating and

delivering to investors the information required under Rule 10b-10
would be $8,417,166,447.
    An agency may not conduct or sponsor, and a person is not required
to respond to, a collection of information under the PRA unless it
displays a currently valid OMB control number.
    The public may view background documentation for this information
collection at the following Web site: www.reginfo.gov. Comments should
be directed to: (i) Desk Officer for the Securities and Exchange
Commission, Office of Information and Regulatory Affairs, Office of
Management and Budget, Room 10102, New Executive Office Building,
Washington, DC 20503, or by sending an email to:
<EMAIL_ADDRESS>and (ii) Pamela Dyson, Director/Chief
Information Officer, Securities and Exchange Commission, c/o Remi
Pavlik-Simon, 100 F Street NE., Washington, DC 20549, or by sending an
email to<EMAIL_ADDRESS>Comments must be submitted to OMB within
30 days of this notice.

    Dated: May 4, 2016.
Robert W. Errett,
Deputy Secretary.
[FR Doc. 2016-10888 Filed 5-9-16; 8:45 am]
 BILLING CODE 8011-01-P


[Federal Register Volume 76, Number 231 (Thursday, December 1, 2011)]
[Notices]
[Pages 74845-74846]
[FR Doc No: 2011-30912]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2011-0164]

Reports, Forms, and Recordkeeping Requirements

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

ACTION: Request for public comment on extension of a currently approved
collection of information.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections. This
document describes an existing collection of information for 49 CFR
part 574, Tire Identification and Recordkeeping, for which NHTSA
intends to seek renewed OMB approval.

DATES: Comments must be received on or before January 30, 2012.

ADDRESSES: Comments must refer to the docket number cited at the
beginning of this notice, and may be submitted by any of the following
methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Mail: Docket Management Facility, M-30, U.S. Department of
Transportation, West Building, Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC 20590.
     Hand Delivery or Courier: West Building, Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., between 9 a.m. and 5 p.m.
Eastern Time, Monday through Friday, except Federal Holidays.
Telephone: 1-800-647-2251.
    Instructions: All submissions must include the docket number for
this document. Please identify the collection of information for which
a comment is provided by referencing the OMB Control Number, 2127-0050.
Note that all comments received will be posted without change to http://www.regulations.gov, including any personal information provided.
Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comment, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://DocketsInfo.dot.gov.

FOR FURTHER INFORMATION CONTACT: Mr. Jeffrey Woods, NHTSA, 1200 New
Jersey Avenue SE., Room W43-467, NVS-122, Washington, DC 20590. Mr.
Woods' telephone number is<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation (at 5 CFR
1320.8(d)), an agency must ask for public comment on the following:
    (1) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (2) The accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    (3) How to enhance the quality, utility and clarity of the
information to be collected;
    (4) How to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology (e.g., permitting electronic
submission of responses).
    In compliance with these requirements, NHTSA asks for public
comments on the following collection of information:
    Title: Tire Identification and Recordkeeping.
    OMB Control Number: 2127-0050.
    Form Number: This collection of information uses no standard form.
    Type of Request: Extension of a currently approved collection of
information.
    Summary of the Collection of Information: 49 U.S.C. 30117(b)
requires each tire manufacturer to collect and maintain records of the
first purchasers of new tires. To carry out this mandate, 49 CFR part
574, Tire Identification and Recordkeeping, requires tire dealers and
distributors to record the names and addresses of retail purchasers of
new tires and the identification numbers(s) of the tires sold. A
specific form is provided to tire dealers and distributors by tire
manufacturers for recording this information. The completed forms are
returned to the tire manufacturers where they are retained for no less
than five years. Part 574 requires independent tire dealers and
distributors to provide a registration form to consumers with the tire
identification number(s) already recorded and information identifying
the dealer/distributor. The consumer can then record his/her name and
address and return the form to the tire manufacturer via U.S. mail, or
alternatively, the consumer can provide this information electronically
on the tire manufacturer's Web site if the tire manufacturer provides
this capability. Additionally, motor vehicle manufacturers are required
to record the names and addresses of the first purchasers (for purposes
other than resale), together with the identification numbers of the
tires on the new vehicle, and retain this information for no less than
five years.
    Description of the Need for the Information and the Use of the
Information: The information is used by a tire manufacturer after it or
the agency determines that some of its tires either fail to comply with
an applicable safety standard or contain a safety related defect. With
the information, the tire manufacturer can notify the first purchaser
of the tire and provide them with any necessary information or
instructions to remedy the non-compliance situation or safety defect.
    Without this information, efforts to identify the first purchaser
of tires that have been determined to be defective or nonconforming
pursuant to Sections 30118 and 30119 of Title 49 U.S.C. would be
impeded. Further, the ability of the purchasers to take appropriate
action in the interest of motor vehicle safety may be compromised.
    Description of the Likely Respondents (Including Estimated Number
and Proposed Frequency of Response to the Collection of Information):
We estimate that the collection of information affects 10 million
respondents annually. This group consists of approximately 20 tire

manufacturers, 59,000 new tire dealers and distributors and 10 million
consumers who choose to register their tire purchases with tire
manufacturers. A response is required by motor vehicle manufacturers
upon each sale of a new vehicle and by non-independent tire dealers
with each sale of a new tire. A consumer may elect to respond when
purchasing a new tire from an independent tire dealer.
    Estimate of the Total Annual Reporting and Recordkeeping Burden
Resulting from the Collection of Information: The estimated burden is
as follows:
    New tire dealers and distributors: 59,000.
    Consumers: 10,000,000.
    Total tire registrations (manual): 54,000,000.
    Total tire registration hours (manual): 225,000.
    Recordkeeping hours (manual): 25,000.
    Total annual tire registration and recordkeeping hours: 250,000.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility, the accuracy of the Department's estimate of the burden of the
proposed information collection, ways to enhance the quality, utility
and clarity of the information to be collected and ways to minimize the
burden of the collection of information on respondents, including the
use of automated collection techniques or other forms of information
technology.

    Issued on: November 23, 2011.
Christopher J. Bonanti,
Associate Administrator for Rulemaking.
[FR Doc. 2011-30912 Filed 11-30-11; 8:45 am]
BILLING CODE 4910-59-P


[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Notices]
[Page 68834]
[FR Doc No: 2013-27292]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 405-106]

Exelon Generation Company, LLC; Notice of Staff Attendance at
Meeting

    On Wednesday, November 13, 2013, Commission staff will attend the
Maryland Department of Natural Resources (Maryland DNR) Open House on
the Conowingo Dam Relicensing Process. The purpose of the Open House is
for Maryland DNR to provide local citizens and stakeholders with
information on the relicensing process and timeline for Exelon
Generation Company's Conowingo Hydroelectric Project No. 405.
    The Open House will be held from 7:00 p.m. to 9:30 p.m. at the
Harford Community College, Chesapeake Center Theater, 401 Thomas Run
Road, Bel Air, Maryland 21015. For further information, visit Maryland
DNR's Web site at http://www.dnr.maryland.gov/waters/Conowingo.asp.
Please take note that Commission staff will only be able to address
procedural questions related to the Conowingo relicensing process.

    Dated: November 6, 2013.
Kimberly D. Bose,
Secretary.
[FR Doc. 2013-27292 Filed 11-14-13; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Pages 8091-8092]
[FR Doc No: 2019-03999]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP19-89-000]

Columbia Gas Transmission, LLC; Notice of Request Under Blanket
Authorization

    Take notice that on February 19, 2019, Columbia Gas Transmission,
LLC (Columbia), 700 Louisiana Street, Houston, Texas 77002, filed in
Docket No. CP19-89-000, a Prior Notice Request pursuant to sections
157.205 and 157.213(b) of the Commission's regulations under the
Natural Gas Act (NGA), and Columbia's blanket certificate issued in
Docket No. CP83-76-000, requesting authorization to construct and
operate two new horizontal injection/withdrawal (I/W) storage wells and
approximately 450 feet of associated 6-inch-diameter pipeline and
appurtenances at Columbia's Pavonia Storage Field located in Ashland
County, Ohio. Columbia states the proposed wells will provide
approximately 17.4 MMcf/d of restored deliverability to the Columbia
storage system and cost approximately $10 million, all as more fully
described in the application which is on file with the Commission and
open to public inspection. The filing may also be viewed on the web at
http://www.ferc.gov using the eLibrary link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
<EMAIL_ADDRESS>or call toll-free,<PHONE_NUMBER> or TTY,
(202) 502-8659.
    Any questions regarding this prior notice should be directed to
Linda Farquhar, Manager, Project Determinations & Regulatory
Administration, Columbia Gas Transmission, LLC, 700 Louisiana Street,
Suite 700, Houston, Texas 77002, by phone at<PHONE_NUMBER>, by fax at
(832) 320-6685, or by email at<EMAIL_ADDRESS>    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
complete its environmental assessment (EA) and place it into the
Commission's public

record (eLibrary) for this proceeding; or issue a Notice of Schedule
for Environmental Review. If a Notice of Schedule for Environmental
Review is issued, it will indicate, among other milestones, the
anticipated date for the Commission staff's issuance of the EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's EA.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commenters will be
placed on the Commission's environmental mailing list and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters will not receive copies of all documents filed by other
parties or issued by the Commission and will not have the right to seek
court review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
protests, and interventions in lieu of paper using the eFiling link at
http://www.ferc.gov. Persons unable to file electronically should
submit an original and 3 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE, Washington,
DC 20426.

    Dated: February 28, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-03999 Filed 3-5-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 147 (Tuesday, July 31, 2012)]
[Rules and Regulations]
[Page 45247]
[FR Doc No: 2012-18700]

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

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0702]

Drawbridge Operation Regulations; Gallants Channel, Beaufort, NC

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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SUMMARY: The Commander, Fifth Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
US 70 (Grayden Paul) Bridge, at mile 0.1, over Gallants Channel, at
Beaufort, NC. The deviation restricts the operation of the draw span
and is necessary to accommodate the Neuse River Keeper Foundation
Sprint Triathlon.

DATES: This deviation is effective 12:30 p.m. until 3 p.m. on Saturday,
September 29, 2012.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket USCG-2012-0702 and are available online by going to http://www.regulations.gov, inserting USCG-2012-0702 in the ``Keywords'' box,
and then clicking ``Search''. This material is also available for
inspection or copying the Docket Management Facility (M-30), U.S.
Department of Transportation, West Building Ground Floor, Room W12-140,
1200 New Jersey Avenue SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal Holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Bill H. Brazier, Bridge Management Specialist, Fifth
Coast Guard District, telephone<PHONE_NUMBER>, email
<EMAIL_ADDRESS>If you have questions on reviewing the docket,
call Renne V. Wright, Program Manager, Docket Operations, (202)366-
9826.

SUPPLEMENTARY INFORMATION: The North Carolina Department of
Transportation who owns and operates this bascule-type drawbridge, on
behalf of the Coastal Society, has requested a temporary deviation from
the operating regulations to accommodate the Neuse River Keeper
Foundation Sprint Triathlon.
    Under the current operating regulations set out in 33 CFR 117.823,
the draw of the US 70 (Grayden Paul) Bridge, at mile 0.1, over Gallants
Channel, at Beaufort, NC opens as follows: From 6 a.m. to 10 p.m., the
draw need only open on the hour and on the half hour; except that
Monday through Friday the bridge need not open between the hours of
6:30 a.m. to 8 a.m. and 4:30 p.m. to 6 p.m.; and from 10 p.m. to 6
a.m., the bridge will open on signal.
    In the closed position to vessels, the US 70 (Grayden Paul) Bridge
has a vertical clearance of 13 feet above mean high water.
    Under this temporary deviation, the drawbridge will be closed to
vessels requiring an opening from 12:30 p.m. to 3 p.m. on Saturday,
September 29, 2012. There are no alternate routes for vessels
transiting this section of Gallants Channel and the drawbridge will be
able to open in the event of an emergency.
    The Coast Guard has carefully coordinated the restrictions with
commercial and recreational waterway users. The Coast Guard will inform
all users of the waterway through our Local and Broadcast Notice to
Mariners of the closure periods for the bridge so that vessels can
arrange their transits to minimize any impacts caused by the temporary
deviation.
    In accordance with 33 CFR 117.35(e), the draw must return to its
original operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: July 23, 2012.
Waverly W. Gregory, Jr.,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2012-18700 Filed 7-30-12; 8:45 am]
BILLING CODE 9110-04-P