[Federal Register Volume 76, Number 87 (Thursday, May 5, 2011)]
[Rules and Regulations]
[Pages 25542-25545]
[FR Doc No: 2011-10955]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1

[Docket No. FDA-2011-N-0179]
RIN 0910-AG65

Information Required in Prior Notice of Imported Food

AGENCY: Food and Drug Administration, HHS.

ACTION: Interim final rule; request for comments.

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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations on prior notice of imported food. As required by the FDA
Food Safety Modernization Act, FDA is issuing this interim final rule
to require an additional element of information in a prior notice of
imported food. This change requires a person submitting prior notice of
imported food, including food for animals, to report the name of any
country to which the article has been refused entry. The new
information can help FDA make better informed decisions in managing the
potential risks of imported food into the United States.

DATES: This interim final rule is effective July 3, 2011. Interested
persons may submit either electronic or written comments on this
interim final rule by August 3, 2011. Submit comments on information
collection issues under the Paperwork Reduction Act of 1995 by June 6,
2011 (see the ``Paperwork Reduction Act of 1995'' section of this
document (section IV of this document).

FOR FURTHER INFORMATION CONTACT: Anthony C. Taube, Office of Regulatory
Affairs, Office of Regional Operations, Food and Drug Administration,
12420 Parklawn Dr., ELEM-4051, Rockville, MD 20857,<PHONE_NUMBER>.

ADDRESSES: You may submit comments on this interim final rule,
identified by Docket No. FDA-2011-N-0179 and/or RIN number 0910-AG65 by
any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name
and docket number and Regulatory Information Number (RIN) for this
rulemaking. All comments received may be posted without change to
http://www.regulations.gov, including any personal information
provided. For additional information on submitting comments, see the
``Comments'' heading of the SUPPLEMENTARY INFORMATION section of this
document.
    Docket: For access to the docket to read background documents or
comments received, go to http://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 Division of
Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

SUPPLEMENTARY INFORMATION:

I. Background

A. Legal Background

    Each year about 48 million people (1 in 6 Americans) are sickened,
128,000 are hospitalized, and 3,000 die from food borne diseases,
according to recent data from the Centers for Disease Control and
Prevention. This is a significant public health burden that is largely
preventable.
    The FDA Food Safety Modernization Act (FSMA) (Pub. L. 111-353),
signed into law by President Obama on January 4, 2011, enables FDA to
better protect public health by helping to ensure the safety and
security of the food supply. It enables FDA to focus more on preventing
food safety problems rather than relying primarily on reacting to
problems after they occur. The law also provides FDA with new
enforcement authorities to help it achieve higher rates of compliance
with prevention- and risk-based food safety standards and to better
respond to and contain problems when they do occur. The law also gives
FDA important new tools to better ensure the safety of imported foods
and directs FDA to build an integrated national food safety system in
partnership with State and local authorities.
    Section 304 of FSMA amends section 801(m) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 381(m)) to require that
additional information be provided in a prior notice of imported food
submitted to FDA. This change requires a person submitting prior notice
of imported food, including food for animals, to report, in addition to
other information already required, ``any country to which the article
has been refused entry.'' Section 304 of FSMA also requires the
Secretary of Health and Human Services to issue an interim final rule
implementing this statutory change no later than 120 days following the
date of enactment of the legislation and provides that the amendment
made by section 304 of FSMA takes effect 180 days after the date of
enactment, which is July 3, 2011.

B. Brief History of Prior Notice

    The Public Health Security and Bioterrorism Preparedness and
Response Act of 2002 (the Bioterrorism Act) was signed into law on June
12, 2002. Among other things, the Bioterrorism Act amended the FD&C Act
by adding section 801(m). This provision created the requirement that
FDA receive certain information about imported foods before arrival in
the United States. It also provided that an article of food imported or
offered for import is subject to refusal of admission into the United
States if adequate prior notice has not been provided to FDA. The
Secretary of Health and Human Services was directed to issue
implementing regulations, after consultation with the Secretary of the
Treasury, by December 12, 2003, requiring prior notice of imported
food.
    In accordance with the Bioterrorism Act, the Department of Health
and Human Services (HHS) and the Department of the Treasury jointly
published a notice of proposed rulemaking (proposed rule) in the
Federal Register of February 3, 2003 (68 FR 5428), proposing
requirements for submission of prior notice for human and animal food
that is imported or offered for import into the United States. On
October 10, 2003, HHS and the Department of Homeland Security (DHS) \1\
issued the prior notice interim

final rule (2003 IFR) (68 FR 58974) (corrected by a technical amendment
on February 2, 2004; 69 FR 4851). The 2003 IFR required that prior
notice be submitted to FDA electronically using either the U.S. Customs
and Border Protection (CBP) Automated Broker Interface (ABI) of the
Automated Commercial System (ACS) or the FDA Prior Notice System
Interface (PNSI). The 2003 IFR also set forth the timeframes within
which prior notice must be submitted.
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    \1\ On May 15, 2003, the Treasury Department issued Treasury
Department Order Number No. 100-16 delegating to the DHS its
authority related to the customs revenue functions, with certain
delineated exceptions in which the Treasury Department retained its
authority. See Appendix to 19 CFR Part 0. The Treasury Department
transferred to DHS its regulatory authority relating to the
requirements for prior notices. Thus the Secretary of HHS issued the
regulations implementing section 801(m) of the FD&C Act (21 U.S.C.
381(m)) jointly with the Secretary of Homeland Security. Similarly,
this interim final rule is being issued jointly with the Secretary
of Homeland Security.
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    In the Federal Register of November 7, 2008 (73 FR 66294), HHS and
DHS published a final rule that made a number of changes to the 2003
IFR, including changes to certain provisions containing definitions,
submission timeframes, and the information that must be submitted in a
prior notice. The final rule went into effect on May 6, 2009. In
calendar year 2010, 10,116,018 prior notices were submitted, 8,570,497
of which were submitted through the CBP system with the remaining
1,545,521 being submitted through the FDA system.
    The prior notice regulations are codified at Title 21, Code of
Federal Regulations (CFR) part 1, subpart I (21 CFR 1.276 to 1.285).
Section 1.281 of the regulations describes the information that must be
submitted in a prior notice. This interim final rule amends those
regulations as required by section 304 of FSMA. Specifically, the
interim final rule is amending paragraphs (a), (b), and (c) of Sec.
1.281 to require that the prior notice include the identity of any
country to which an article of food has been refused entry.

II. Executive Orders 12866 and 13563: Cost Benefit Analysis

    FDA has examined the impacts of this interim final rule under
Executive Orders 12866 and 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). Executive Order 13563 emphasizes the importance of quantifying
both costs and benefits, of reducing costs, of harmonizing rules, and
of promoting flexibility. OMB has determined that this is a significant
regulatory action as defined by the Executive Orders.
    The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the costs per entity of this rule are small,
the Agency also concludes that this final rule will not have a
significant economic impact on a substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) requires that agencies prepare a written statement, which
includes an assessment of anticipated costs and benefits, before
proposing ``any rule that includes any Federal mandate that may result
in the expenditure by State, local, and Tribal governments, in the
aggregate, or by the private sector, of $100,000,000 or more (adjusted
annually for inflation) in any one year.'' The current threshold after
adjustment for inflation is $135 million, using the most current (2009)
Implicit Price Deflator for the Gross Domestic Product. FDA does not
expect this final rule to result in any 1-year expenditure that would
meet or exceed this amount.
    The Economic Impact Analysis of the 2008 Final Rule: (1) Responded
to comments received on the economic analysis of the 2003 IFR, (2)
revised the analysis set forth in the 2003 IFR using new data, (3)
presented an economic analysis of the leading alternative to the 2003
IFR using new data, and (4) explained the marginal benefits and costs
of the final rule itself, relative to the 2003 IFR.
    This Economic Impact Analysis further revises the analysis set
forth in the 2008 final rule by addressing the economic impact of the
new statutory requirement in FSMA.

A. Need for Regulation

    Section 304 of FSMA requires a person submitting prior notice of
imported food, including food for animals, to report the name of any
country to which the article has been refused entry. Requiring notice
of prior refusals allows FDA to better identify imported food shipments
that may pose safety and security risks to U.S. consumers. This
additional knowledge can further help FDA to make better informed
decisions in managing the potential risks of imported food shipments
into the United States. This interim final rule implements section 304
of FSMA by amending the rule that is already in effect.

B. Costs

    In the 2003 IFR (68 FR 58974 at 59027), FDA estimated that it takes
1 hour on average to submit the prior notices for each import entry,
and this estimate was not revised for the 2008 final rule. In the final
rule (73 FR 66294 at 66386), FDA estimated that, on average, one import
entry includes 3.6 distinct food articles or lines and thus requires
3.6 prior notices per import entry. For the final rule the estimated
cost of submitting prior notice was $75 per entry assuming 3.6 lines
per entry. This estimate includes 45 minutes of an administrative
worker's time to gather information to initially complete the prior
notice, and then 15 minutes of a manager's time to verify that the
information is correct.
    Additional costs associated with implementing changes in this
interim final rule will be borne by all persons who submit prior notice
for an article of food that is imported or offered for import into the
United States. These costs are estimated as the additional time it will
take for a person to gather and verify the information about whether
the article was refused entry and to enter the information into an
electronic system. To the extent that the information is readily
available and verifiable, we reason that it could take as few as 7
seconds to as many as 108 seconds per entry to do this. In 2010, FDA
received 10,116,018 prior notices. In the 2008 economic analysis, FDA
estimated an average of 3.6 prior notices (lines) per entry. For
purposes of this analysis we consider 3.6 to be a likely approximation
of the current number of lines per entry. By dividing the number of
prior notices by the 3.6 lines per entry we estimate that there are
currently 2.8 million imported food entries (10,116,018 divided by
3.6). By multiplying the number of entries by the additional seconds,
we estimate the additional number of hours to provide the additional
information for all prior notice submitters to be an average of about
45,000 hours per year. Table 1 of this document shows the possible
additional time ranges that submitters may need in order to comply with
this interim final rule. The economic impact analysis of the 2008 final
rule estimated that the prior notice submissions for some entries (3.6
prior notices per entry) can take more than 1 hour to complete and
others may take less than 1 hour. The amount of time needed to complete
the submission for an entry can reasonably vary by several minutes. As
seen in table 1 of this document, the

additional average time of 58 seconds required to provide this
information is estimated as the average of 7 and 108 seconds per entry.
Since the additional time required to provide the new information is a
small fraction of the variation in time it can take to complete the
prior notice for an entry, the marginal cost for the additional 58
seconds (on average) that it would take to provide the additional
information would be negligible.

               Table 1--Estimated Range of Time Needed for Reading and/or Entering New Information
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                                              Calculation
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(A) Number of prior notices (lines)    A........................      10,116,018      10,116,018      10,116,018
 in 2010 *.
(B) Lines per entry **...............  B........................             3.6             3.6             3.6
(C) Food entries per year............  C = A/B..................       2,810,005       2,810,005       2,810,005
(D) Number of submitters ***.........  D........................         129,757         129,757         129,757
(E) Entries per submitter............  E = C/D..................              22              22              22
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                                                                    Lower bound       Average       Upper bound
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(F) Additional time per line           F........................               2              16              30
 (seconds).
(G) Additional time per entry          G = B x F................               7              58             108
 (seconds).
(H) Additional hours per entry.......  H = G/3,600..............           0.002           0.016           0.030
(I) Additional hours per submitter     I = H x E................            0.04            0.35            0.65
 per year.
(J) Additional hours per year for all  J = C x H................           5,620          44,960          84,300
 submitters.
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* Data from FDA Prior Notice Center.
** Based on estimate in the Federal Register of November 7, 2008 (73 FR 66294 at 66386).
*** OASIS 2010 data.

C. Benefits

    FDA's prior notice system provides us with enhanced knowledge of
what articles of food are being imported or offered for import into the
United States. Requiring prior notice of imported food shipments and
defining the required data improves our ability to detect accidental
and deliberate contamination of food and to deter deliberate
contamination.
    Before prior notice was required, FDA received almost no advance
notice information about food products entering the United States from
foreign sources, or the location of the food's anticipated port of
arrival. With the information required by prior notice, FDA does know
what articles of food are being imported or offered for import before
they arrive at the port. In the event of a credible threat for a
specific product or a specific manufacturer or processor, for example,
FDA will be able to mobilize and assist in the detention and removal of
products that may pose a serious health threat to humans or animals.
    FDA's Prior Notice Center reviews prior notices and assesses the
risk related to imported food shipments. FDA will be able to use the
additional information from this interim final rule to better identify
imported food shipments that may pose a safety or security risk to U.S.
consumers. Personnel at the Prior Notice Center decide on a case-by-
case basis whether the article of food needs to be held for examination
upon arrival at the port. Having notice of an article of food imported
or offered for import into the United States before it reaches a U.S.
port allows FDA personnel to be ready at any time to respond to
shipments that appear to pose a significant health risk to humans or
animals.

III. Small Entity Analysis

    FDA examined the economic implications of this interim final rule
as required by the Regulatory Flexibility Act (5 U.S.C. 601-612). If a
rule has a significant economic impact on a substantial number of small
entities, the Regulatory Flexibility Act requires us to analyze
regulatory options that would lessen the economic effect of the rule on
small entities.
    The Regulatory Flexibility Act requires analyzing options for
regulatory relief for small businesses. Because the compliance costs
are negligible, FDA finds that this interim final rule is not a
significant regulatory action as defined by Executive Order 12866. In
compliance with the Regulatory Flexibility Act this interim final rule
will not have a significant impact on a substantial number of small
businesses.

IV. Paperwork Reduction Act of 1995

    This interim final rule contains information collection
requirements that are subject to review by the Office of Management and
Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520). The title, description, and respondent description of these
requirements are shown below with an estimate of the annual reporting
burden. Included in the estimate is the time for reviewing
instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
    FDA invites comments on: (1) Whether the proposed collection of
information is necessary for the proper performance of FDA's functions,
including whether the information will have practical utility; (2) the
accuracy of FDA's estimate of the burden of the proposed collection of
information, including the validity of the methodology and assumptions
used; (3) ways to enhance the quality, utility, and clarity of the
information to be collected; and (4) ways to minimize the burden of the
collection of information on respondents, including through the use of
automated collection techniques, when appropriate, and other forms of
information technology.
    Title: Information Required in Prior Notice of Imported Food.
    Description: FDA is issuing regulations to require a person
submitting prior notice of imported food, including food for animals,
to report, in addition to other information already required, ``any
country to which the article has been refused entry.'' Persons
submitting prior notice will gather and verify information about
whether the article was refused entry to any country and enter the
information into an electronic system.
    Description of Respondents: All persons who submit prior notice for
an article of food that is imported or offered for import into the
United States. FDA estimated that in 2010 there were about 129,757
prior notice submitters.
    Burden: FDA estimates the burden of this collection of information
as follows:

                                 Table 2--Estimated Annual Reporting Burden \1\
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                                                                                Average
                                  Number of       Number of       Total annual      burden per
        21 CFR section           respondents    responses per      responses       response  (in    Total hours
                                                 respondent                           hours)
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1.281........................         129,757              22  2.8 million......           0.016          44,960
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    The number of annual responses is equivalent to the annual number
of entries that are submitted. In 2010, FDA received 10,116,018 prior
notices. By dividing the number of prior notices by the average number
of lines per entry, we estimate 2.8 million entries. By further
dividing the number of entries by the number of respondents, we
estimate the average annual frequency per response to be 22. We
estimate that it would take on average about 58 seconds (0.016 hours)
for each respondent to submit the additional information as part of
prior notice. By multiplying the number of entries by the additional 58
seconds, we estimate the total number of hours to provide the
additional information to be an average of approximately 45,000 hours
per year which also translates to about 20 minutes (0.35 hours) per
year per respondent.
    The information collection provisions for this interim final rule
have been submitted to OMB for review as required by section 3507(d) of
the Paperwork Reduction Act of 1995. The requirements were approved and
assigned OMB control number 0910-0683. This approval expires April 30,
2014. An agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
    Interested persons are requested to fax comments regarding
information collection by June 6, 2011, to the Office of Information
and Regulatory Affairs, OMB. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All comments should be identified with the
title, Information Required in Prior Notice of Imported Food.

V. Analysis of Environmental Impact

    The Agency has carefully considered the potential environmental
effects of this action. FDA has concluded under 21 CFR 25.30(h) that
this action is of a type that does not individually or cumulatively
have a significant effect on the human environment. Therefore, neither
an environmental assessment nor an environmental impact statement is
required.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects 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. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.

VII. Comments

    The requirements in this interim final rule will be in effect on
July 3, 2011. FDA invites public comment on this interim final rule,
and will consider modifications to it based on comments made during the
comment period. Interested persons may submit to the Division of
Dockets Management (see ADDRESSES) either electronic or written
comments regarding this document. It is only necessary to send one set
of comments. It is no longer necessary to send two copies of mailed
comments. Identify comments with the docket number found in brackets in
the heading of this document. Received comments may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

List of Subjects in 21 CFR Part 1

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

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
1 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 1.281 is amended by adding paragraphs (a)(18), (b)(12), and
(c)(19) to read as follows:

Sec.  1.281  What information must be in a prior notice?

    (a) * * *
    (18) Any country to which the article has been refused entry.
    (b) * * *
    (12) Any country to which the article has been refused entry.
    (c) * * *
    (19) Any country to which the article has been refused entry.

    Dated: April 29, 2011.
Janet Napolitano,
Secretary of Homeland Security.
    Dated: April 29, 2011.
Kathleen Sebelius,
Secretary of Health and Human Services.
[FR Doc. 2011-10955 Filed 5-4-11; 8:45 am]
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[Federal Register Volume 79, Number 219 (Thursday, November 13, 2014)]
[Notices]
[Page 67438]
[FR Doc No: 2014-26821]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-0001]

Science Board to the Food and Drug Administration Advisory
Committee Meeting; Amendment of Notice

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an
amendment to the notice of meeting of the Science Board to the Food and
Drug Administration. This meeting was announced in the Federal Register
of October 8, 2014. The amendment is being made to reflect changes in
URL for the Webcast. There are no other changes.

FOR FURTHER INFORMATION CONTACT: Martha Monser, Office of the Chief
Scientist, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 1, Rm. 3309, Silver Spring, MD 20993,<PHONE_NUMBER>, or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area). Please call the Information Line for up-to-
date information on this meeting.

SUPPLEMENTARY INFORMATION: In the Federal Register of October 8, 2014
(79 FR 60856), FDA announced that a meeting of the Science Board to the
Food and Drug Administration would be held on November 19 and 20, 2014.
On page 60857, in the first column, the URL information is changed to
read as follows:
    The link for the Webcast on November 19, 2014, is available at:
https://collaboration.fda.gov/scienceboard111914/. The link for the
Webcast on November 20, 2014, is available at: https://collaboration.fda.gov/scienceboard112014.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app. 2) and 21 CFR part 14, relating to the advisory committees.

    Dated: November 5, 2014.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2014-26821 Filed 11-12-14; 8:45 am]
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[Federal Register Volume 77, Number 204 (Monday, October 22, 2012)]
[Notices]
[Pages 64585-64586]
[FR Doc No: 2012-25911]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[FMCSA Docket No. FMCSA-2012-0218]

Qualification of Drivers; Exemption Applications; Diabetes
Mellitus

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

ACTION: Notice of final disposition.

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SUMMARY: FMCSA announces its decision to exempt 28 individuals from its
rule prohibiting persons with insulin-treated diabetes mellitus (ITDM)
from operating commercial motor vehicles (CMVs) in interstate commerce.
The exemptions will enable these individuals to operate CMVs in
interstate commerce.

DATES: The exemptions are effective October 22, 2012. The exemptions
expire on October 22, 2014.

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

SUPPLEMENTARY INFORMATION:

Electronic Access

    You may see all the comments online through the Federal Document
Management System (FDMS) at: http://www.regulations.gov.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov and/or Room W12-140 on the
ground level of the West Building, 1200 New Jersey Avenue SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of DOT's dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, or other
entity). You may review DOT's Privacy Act Statement for the Federal
Docket Management System (FDMS) published in the Federal Register on
January 17, 2008 (73 FR 3316), or you may visit http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

Background

    On August 29, 2012, FMCSA published a notice of receipt of Federal
diabetes exemption applications from 28 individuals and requested
comments from the public (77 FR 52384). The public comment period
closed on September 28, 2012, and two comments were received.
    FMCSA has evaluated the eligibility of the 28 applicants and
determined that granting the exemptions to these individuals would
achieve a level of safety equivalent to or greater than the level that
would be achieved by complying with the current regulation 49 CFR
391.41(b)(3).

Diabetes Mellitus and Driving Experience of the Applicants

    The Agency established the current requirement for diabetes in 1970
because several risk studies indicated that drivers with diabetes had a
higher rate of crash involvement than the general population. The
diabetes rule provides that ``A person is physically qualified to drive
a commercial motor vehicle if that person has no established medical
history or clinical diagnosis of diabetes mellitus currently requiring
insulin for control'' (49 CFR 391.41(b)(3)).
    FMCSA established its diabetes exemption program, based on the
Agency's July 2000 study entitled ``A Report to Congress on the
Feasibility of a Program to Qualify Individuals With Insulin-Treated
Diabetes Mellitus To Operate in Interstate Commerce as Directed by the
Transportation Act for the 21st Century.'' The report concluded that a
safe and practicable protocol to allow some drivers with ITDM to
operate CMVs is feasible. The September 3, 2003 (68 FR 52441), Federal
Register notice in conjunction with the November 8, 2005 (70 FR 67777),
Federal Register notice provides the current protocol for allowing such
drivers to operate CMVs in interstate commerce.
    These 28 applicants have had ITDM over a range of 1 to 46 years.
These applicants report no severe hypoglycemic reactions resulting in
loss of consciousness or seizure, requiring the assistance of another
person, or resulting in impaired cognitive function that occurred
without warning symptoms, in the past 12 months and no recurrent (2 or
more) severe hypoglycemic episodes in the past 5 years. In each case,
an endocrinologist verified that the driver has demonstrated a
willingness to properly monitor and manage his/her diabetes mellitus,
received education related to diabetes management, and is on a stable
insulin regimen. These drivers report no other disqualifying
conditions, including diabetes-related complications. Each meets the
vision requirement at 49 CFR 391.41(b)(10).
    The qualifications and medical condition of each applicant were
stated and discussed in detail in the August 29, 2012, Federal Register
notice and they will not be repeated in this notice.

Discussion of Comments

    FMCSA received two comments in this proceeding. Mr. Lyle Brandstrom
stated that he had worked with Daniel John Gladen and is in favor of
granting him a Federal Diabetes exemption. According to Mr. Brandstrom,
Mr. Gladen is a dedicated and responsible driver.
    Mr. Curtus Sherman stated that he had worked with Daniel John
Gladen and is in favor of granting him a Federal Diabetes exemption.
According to Mr. Sherman, Mr. Gladen is a dedicated and responsible
driver.

Basis for Exemption Determination

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the diabetes requirement in 49 CFR 391.41(b)(3) if the exemption
is likely to achieve an equivalent or greater level of safety than
would be achieved without the exemption. The exemption allows the
applicants to operate CMVs in interstate commerce.
    To evaluate the effect of these exemptions on safety, FMCSA
considered medical reports about the applicants' ITDM and vision, and
reviewed the treating endocrinologists' medical opinion related to the
ability of the driver to safely operate a CMV while using insulin.
    Consequently, FMCSA finds that in each case exempting these
applicants from the diabetes requirement in 49 CFR 391.41(b)(3) is
likely to achieve a level of safety equal to that existing without the
exemption.

Conditions and Requirements

    The terms and conditions of the exemption will be provided to the
applicants in the exemption document and they include the following:
(1) That each individual submit a quarterly monitoring checklist
completed by the treating endocrinologist as well as an annual
checklist with a comprehensive medical evaluation; (2) that each
individual reports within 2 business days of occurrence, all episodes
of severe hypoglycemia, significant complications, or inability to
manage diabetes; also, any involvement in an accident or any other
adverse event in a CMV or personal vehicle, whether or not it is
related to an episode of hypoglycemia; (3) that each individual provide
a copy of the ophthalmologist's

or optometrist's report to the medical examiner at the time of the
annual medical examination; and (4) that each individual provide a copy
of the annual medical certification to the employer for retention in
the driver's qualification file, or keep a copy in his/her driver's
qualification file if he/she is self-employed. The driver must also
have a copy of the certification when driving, for presentation to a
duly authorized Federal, State, or local enforcement official.

Conclusion

    Based upon its evaluation of the 28 exemption applications, FMCSA
exempts Anthony J. Annatone (FL), Trevor J. Corley (TX), Shannon K.
Ellingsworth (KY), Richard T. Ewell (IL), Norman S. Forsythe (WI),
Patrick D. Fortier (MN), Daniel J. Gladen (MN), Walter V. Gruba (VA),
Marshall D. Howell (MI), Larry Knox (AK), Roger P. LaFever (WI), Blaze
E. Lampman (NY), William R. Lawrence (MT), Duane J. Mullins (WI), Louis
R. Noellsch (WA), Darrin W. Pettis (WA), Michael J. Raposa (MA), Jeremy
K. Redger (LA), Anthony E. Reed (MO), Earl L. Slater (NY), Keith J.
Tavares (MA), Phillip L. Truitt (MD), Gregory H. Tullock (NJ), Michael
D. Underwood (AL), Raffaele Vano (NY), Brian D. Weeden (NH), David A.
Weinbroer (KY) and Robert J. Westover (WI) from the ITDM requirement in
49 CFR 391.41(b)(3), subject to the conditions listed under
``Conditions and Requirements'' above.
    In accordance with 49 U.S.C. 31136(e) and 31315 each exemption will
be valid for two years unless revoked earlier by FMCSA. The exemption
will be revoked if the following occurs: (1) The person fails to comply
with the terms and conditions of the 1/exemption; (2) the exemption has
resulted in a lower level of safety than was maintained before it was
granted; or (3) continuation of the exemption would not be consistent
with the goals and objectives of 49 U.S.C. 31136(e) and 31315. If the
exemption is still effective at the end of the 2-year period, the
person may apply to FMCSA for a renewal under procedures in effect at
that time.

    Issued on: October 9, 2012.
 Larry W. Minor,
 Associate Administrator for Policy.
[FR Doc. 2012-25911 Filed 10-19-12; 8:45 am]
BILLING CODE 4910-EX-P


1Section 182( b)( 3) specifies that EPA would approve any request from a State to reclassify to a higher classification.

1 Technical Support Document for Memphis Ozone Nonattainment Area September 2004 1.0 Summary.

The States of Tennessee and Arkansas presented a petition to EPA, Regions 4 and 6, requesting downward reclassification of the Memphis Ozone Nonattainment Area ( MONA) from Moderate to Marginal for the 8 hour ozone standard. The petition was presented to EPA July 15, 2004. The petition is based on the area's Moderate design value of 92 ppb being within 5% of the maximum Marginal design value of 0.091 ppm as allowed by the Clean Air Act.

2.0 Introduction.

This section describes the statutory provisions and EPA guidance regarding reclassification of ozone nonattainment areas. Sections 181( a)( 4) and 182( b)( 3) of the Clean Air Act provide that areas may be reclassified under certain circumstances. This technical support document addresses the provisions of section 181( a)( 4) and a specific request for reclassifications received by the State of Michigan. The EPA has not received any requests for reclassification under section 182( b)( 3) for the 8 hour ozone standard. 1 Under section 181( a)( 4), an ozone nonattainment area may be reclassified " if an area classified under paragraph ( 1) ( Table 1) would have been classified in another category if the design value in the area were 5 percent greater or 5 percent less than the level on which such classification was based." In the April 30, 2004 notice, we indicated that an area with a moderate design value of 96 ppb ( or less) would be eligible to request a bump down because five percent less than 96 ppb is 91 ppb, a marginal design value.

The EPA previously described criteria to implement the section 181( a)( 4) provisions in a final rule designating and classifying areas published on November 6, 1991 ( 56 FR 56698). As stated in that notice, the provisions of section 181( a)( 4) set out general criteria and grant the Administrator broad discretion in making or determining not to make, a reclassification. As part of the 1991 action, EPA developed more specific criteria to evaluate 2 whether it is appropriate to reclassify a particular area. The EPA also described these criteria in the April 30, 2004 final rule. The general and specific criteria are as follows:

General: The EPA may consider the number of exceedances of the national primary ambient air quality standard for ozone in the area, the level of pollution transport between the area and other affected areas, including both intrastate and interstate transport, and the mix of sources and air pollutants in the area.

Request by State: The EPA does not intend to exercise its authority to bump down areas on EPA's own initiative. Rather, EPA intends to rely on the State to submit a request for a bump down. A Tribe may also submit such a request and, in the case of a multi state nonattainment area, all affected States must submit the reclassification request.

Discontinuity: A five percent reclassification must not result in an illogical or excessive discontinuity relative to surrounding areas. In particular, in light of the areawide nature of ozone formation, a reclassification should not create a " donut hole" where an area of one classification is surrounded by areas of higher classification.

Attainment: Evidence should be available that the proposed area would be able to attain by the earlier date specified by the lower classification in the case of a bump down.

Emissions reductions: Evidence should be available that the area would be very likely to achieve the appropriate total percent emission reduction necessary in order to attain in the shorter time period for a bump down.

Trends: Near and long term trends in emissions and air quality should support a reclassification. Historical air quality data should indicate substantial air quality improvement for a bump down. Growth projections and emission trends should support a bump down. In addition, we will consider whether vehicle miles traveled and other indicators of emissions are increasing at higher than normal rates.

Years of data: For the 8 hour ozone standard, the 2001 2003 period is central to determining classification. Data from 2004 may be used to corroborate a bump down request but should not be the sole foundation for the bump down request. 3 Limitations on Bump Downs An area may only be reclassified to the next lower classification. An area cannot present data from other years as justification to be reclassified to an even lower classification. In addition, section 181( a)( 4) does not permit moving areas from subpart 2 into subpart 1.

In 1991, EPA approved reclassifications when the area met the first requirement ( a request by the State to EPA) and at least some of the other criteria and did not violate any of the criteria ( emissions, reductions, trends, etc.). In our April 30, 2004 final rule on designations and classifications, we stated our intention to use this method and these criteria once again to evaluate reclassification requests under section 181( a)( 4), with minor changes described in that notice. In that notice we also described how we applied these criteria in 1991. For additional information, see section 5, " Areas requesting a 5% downshift per § 181( a)( 4) and EPA's response to those requests," of the Technical Support Document, October 1991, for the 1991 rule. [ Docket A 90 42A.]

EPA is not basing this reclassification determination on consideration of whether the nonattainment area being reclassified does or does not cause any pollution transport. The EPA is presently addressing ozone pollution transport issues throughout the eastern part of the United States under other Clean Air Act provisions. Specifically, EPA has proposed a determination that emissions from certain states contribute significantly to downwind nonattainment for ozone under CAA section 110( a)( 2)( D) through the Clean Air Interstate Rule ( CAIR). The CAIR proposal, published in a Federal Register notice dated January 30, 2004, would require upwind States to eliminate emissions that contribute significantly to nonattainment in downwind States. 69 Fed. Reg. 454566. The EPA previously issued the NOx SIP call ( 63 FR 57356) to address interstate ozone transport. In the event of any intrastate transport issue, states have the obligation to develop attainment SIPs for each area that show timely attainment, and can address any intrastate transport issues in that context.

The April 30, 2004 notice invited States to submit the reclassification requests within 30 days of the effective date of the designations and classifications. The effective date was June 15 which means that reclassification requests were to be submitted by July 15, 2004. This relatively short time frame is necessary because section 181( a)( 4) only authorizes the Administrator to make such reclassifications within 90 days after 4 the initial classification, September 15, 2004.

3.0 Background.

The MONA was designated nonattainment for the 8 hour ozone standard on April 15, 2004, and classified " Moderate" based on a design value of 92 ppb.

The MONA consists of Shelby County, Tennessee, and Crittenden County, Arkansas. The recently revised Memphis Metropolitan Stastical Area ( MSA), which has a population of just over 1.2 million, includes Shelby, Tipton, and Fayette Counties, Tennessee; DeSoto, Marshall, Tate and Tunica Counties, Mississippi; and Crittenden County, Arkansas. Crittenden County, which lies adjacent to the Mississippi River and just west of Memphis, Tennessee, is mostly a rural county with small communities and little industry. In 2001, Crittenden County reported a population of just over 51,000, while Shelby County ( which includes the City of Memphis) reported a population of 896,000. Fayette County had a population of 31,000, while Tipton County had a population of 53,000. DeSoto County, Mississippi, which is also quite rural and serves as a bedroom community for Memphis, had a population of 114,000. Marshall, Tate and Tunica counties in Mississippi were added to the MSA as a result of the findings of the federal Census Bureau's 2000 Census. In 2001, their populations were reported as: 35,000, 25,000 and 9000, respectively. Interstate 40 runs east west through Crittenden County, while Interstate 55 runs north from the center of the Crittenden County and is adjacent to the City of Memphis.

Within the Memphis MSA, ground level ozone is measured at the Crittenden County monitor, which is located 10 miles northwest of downtown Memphis in Marion, Arkansas; at two monitors in Shelby County ( Edmund Orgill Park and Frayser Street); and at one monitor located in the central part of DeSoto County. In recent years, the Marion monitor has measured some of the highest 1 and 8 hour average ozone concentrations in the Memphis MSA. For example, the 8 hour design values for 2001, 2002, and 2003 at the Marion monitor are 92, 94, and 92 ppb, respectively. Design values for the Shelby County monitors are: 93, 90, and 89 ppb at the Edmund Orgill Park monitor, and 93, 87, and 84 ppb at the Frayser Street monitor. The 8 hour design values at the DeSoto County monitor are 86, 86, and 81 ppb.

4.0 Reclassification Request by States.

The State's request and the rationale is as follows: 5 1. Request by States: The States of Tennessee and Arkansas present this petition.

2. Discontinuity: Multiple screening tests demonstrate that no discontinuity exists with surrounding areas.

3. Attainment: Local modeling and a meteorological adjustment methodology was used in the discussion for attainment.

4. Emissions Reductions: Emissions reductions that were included in the local modeling and additional reductions beyond that modeled are detailed in the petition.

5. Trends: Long term and near term emission and air quality trends support reclassification.

6. Years of Data: 2001  2003 air quality data were used to designate the area to nonattainment.

5.0 EPA Review of the Reclassification Request.

5.1 Request by State. The States of Tennessee and Arkansas submitted the petition by the date required.

5.2 Discontinuity The modeling tests documented in the petition demonstrate that no discontinuity exists with surrounding areas. Since the entire MONA is included in the request and the MONA is surrounded by attainment areas, there will be no area of one classification ( MONA) surrounded by an area of a higher classification.

5.3 Attainment The modeling submitted showed attainment when using methodology for adjusting meteorology. The appropriateness of this method is under review by EPA. The EPA's evaluation of the modeling submitted without a meteorology adjustment and other assumptions shows the design value declining to 88 ppb by 2007, which makes notable progress toward attainment. Also, EPA's Clean Air Interstate Rule ( CAIR) modeling shows the area should have a design value of 86 ppb by 2010, which also shows notable progress towards attainment. In addition, the CAIR modeling does not include any local controls expected prior to 2007. Therefore, local controls could be expected to further lower the CAIR 2010 design value. Both modeling projects indicate more reductions are needed beyond 6 that modeled for attainment by 2007. Additional controls beyond that modeled have been identified and submitted in the petition. Local modeling to assess the impact of the additional controls and to identify and implement more controls if needed will be performed as a part of a monitoring study.

5.4 Emissions Reductions Attainment is expected because of the combination of measures to be implemented and potential measures listed in the petition along with the commitment of the areas to implement additional measures as needed to achieve attainment As strong support for adequate emission reductions being implemented, Arkansas is conducting a study with limited additional modeling which should identify the sources affecting the monitors more precisely. EPA is providing $ 100,000 and Arkansas is providing $ 50,000 for this study. Arkansas, Tennessee and the Memphis Shelby County local agency are committed to assess the results of the study and implement additional controls beyond those modeled or identified in the reclassification petition by 2006, if required by the study results. This commitment is made by the Governors, State, and Local officials of both States as signatories to the petition. In addition, the State of Tennessee and the City of Memphis/ Shelby County have submitted letters reinforcing the commitments to provide additional measures as the modeling and study results might identify.

The petition lists 19 emission reduction measures for potential implementation at the state and local level. Some of these measures are quantifiable and enforceable and others are voluntary. However, these measures, when combined with potential Federal measures expected during the period, could bring the area into attainment by 2007. Tennessee is considering measures such as NOx Reasonably Available Control Technology rules for stationary sources, expanded Stage I vapor recovery, emissions inspections, and antitampering measures. Memphis Shelby county is considering measures such as diesel engine idling limits, reduced speed limits, controlled burning restrictions, and On Board Diagnostic II emission testing. Arkansas is considering measures such as Stage I vapor recovery, truck stop electrification, and replacement/ retrofit construction equipment engines.

In addition, EPA has provided Arkansas with $ 100,000 in funds to implement truck stop electrification in Crittenden 7 County.

5.5 Trends The area's design value is 92 ppb, one ppb above the Marginal classification design value based on 2001  2003 data. The area has not had any exceedences at the Crittenden County monitor in 2004 through September 10. The 4th highest monitor value is 78 ppb. If this value remains the 4th highest for 2004, the design value will decline to 87, well within the Marginal range and only 3 ppb above the attainment level. With the monitor values already established for 2002 and 2003, the Crittenden County monitor could have a 4th high value as high as 91 ppb for 2004 and the design value would still decline from 92 to 91, which is the upper limit for the Marginal classification. Also, with the monitor values already established for 2002 and 2003 for the Shelby County monitors, the 2004 data, to date, are indicating attainment. The design value trends for the two Shelby County monitors have declined since 2000. Air quality trends data from 1982 to 2003 for the Shelby County monitors was reviewed. In addition, from 1998 to present the number of 8 hr ozone exceedances by year have consistently decreased at a majority of the monitors. Therefore, the trends in design value and exceedences indicate the Marginal classification is reasonable at this time. A table of historical design values is in Appendix 6.2.

The emissions from ozone precursors VOC and NOX from stationary sources in Shelby County, TN, have declined significantly since 1993. Emissions estimates in the Memphis MSA ( excluding Marshall, Tate and Tunica), from the Memphis Early Action compact March 31, 2004 submittal, indicate that emissions should decrease by 28% for NOX and 19 % for VOCs from 2001 to 2007. The air quality and emissions trends support reclassification.

Shelby County is included in the NOx SIP call which requires reductions of 57.5 tons per day ( tpd) of NOx emissions from the Tennessee Valley Authority ( TVA) Allen Power Plant. Selective Catalytic Reduction Controls are on all emission units at the TVA Allen Plant. These and other NOx SIP call controls were included in the modeling studies and should further reduce the possibility of regional transport affecting the MONA. The area has yet to fully realize the air quality improvements which will be achieved from the 57.5 tpd reduction. We anticipate drops in the number of 8 exceedences and the magnitude of the 4th highest monitor observations in 2004 which would begin to demonstrate the air quality improvement achieved in response to the measures. Also, it is anticipated the 2004 and 2005 design values will show air quality improvements from these measures.

Population growth projections used in analysis for 8 hour ozone designations show virtually no growth for the MONA between 2000 and 2010. Crittenden County is projected to grow 0.2% and Shelby County 5.2% over the 10 year period. This low level of growth should not add significant emissions to the MONA.

5.6 Years of data The period used for classification is 2001  2003.

5.7 Additional Information The petitioners have emphasized that the States of Tennessee and Arkansas, along with the local governments of Shelby and Crittenden Counties, have produced a plan of action which will result in real ozone reductions and attainment by 2007 through an exhaustive collaborative effort.

EPA Regions 4 and 6 received letters from City, State and Congressional Representatives, supporting approval of the petition. In addition, the Tennessee Chapter of the Sierra Club sent a letter to the Memphis and Shelby County Health Department and copied EPA Region 4 requesting that EPA require public participation in the petition process for reclassification and that the area retain the moderate designation until five years of data are collected to justify a downward reclassification of the area.

EPA Regions 4 and 6 also received additional letters from the State of Tennessee and the City of Memphis/ Shelby County on September 9, 2004, further strengthening the commitment to implement additional measures shown necessary to attain the 8 hour ozone standard by the beginning of the 2006 ozone season ( Appendix 6.1).

5.8 Conclusions The Request by States criteria is satisfied since the petition was submitted by the governors of Tennessee and Arkansas. The Discontinuity criteria is satisfied since the 9 modeling tests submitted showed there would be no area surrounded by one or more areas of higher classification. The Attainment criteria is not failed since the modeling shows notable progress toward attainment. The Emissions Reductions criteria is satisfied because of the emission reductions available and the commitment by the state and local agencies to add any controls necessary to attain the 8 hour standard based on a comprehensive study of sources contributing to nonattainment. The Trends criteria is satisfied since the downward trends in air quality monitor and emissions data and the lack of growth over the time period to attainment are strong indicators of progress towards attainment. The Years of Data criteria is satisfied since the years chosen ( 2001  2003) are consistent with the time period used for the designations for the 8 hour ozone standard. In addition, the air quality monitor data through September 10, 2004, indicates that the area's design value is likely to be in the Marginal range by the end of the 2004 ozone season.

In summary, the data, analysis, and commitments presented in the petition support the likelihood of attainment of the 8 hour NAAQS by 2007 and support the request for downward revision to the 8 hour ozone classification for the MONA. The EPA will be working with the States and the MONA to assist in the development of measures through use of the field study results and updated modeling.

5.9 EPA action The request meets certain criteria EPA established ( request, discontinuity, emission reductions, trends, and data) and does not violate any of the criteria ( attainment). Therefore, EPA is approving the reclassification request for Memphis.

6.0 Additional Information Additional information regarding the bump down request for this area is contained in the docket for this action. This information includes the State request, supporting documents, and other necessary material.


[Federal Register Volume 86, Number 112 (Monday, June 14, 2021)]
[Notices]
[Page 31543]
[FR Doc No: 2021-12509]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting; Cancellation

FEDERAL REGISTER CITATION OF PREVIOUS ANNOUNCEMENT: 86 FR 30342, June
7, 2021.

PREVIOUSLY ANNOUNCED TIME AND DATE OF THE MEETING: Thursday, June 10,
2021 at 2:00 p.m.

CHANGES IN THE MEETING: The Closed Meeting scheduled for Thursday, June
10, 2021 at 2:00 p.m., has been cancelled.

CONTACT PERSON FOR MORE INFORMATION: For further information; please
contact Vanessa A. Countryman from the Office of the Secretary at (202)
551-5400.

    Dated: June 10, 2021.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2021-12509 Filed 6-10-21; 4:15 pm]
BILLING CODE 8011-01-P


[Federal Register: April 11, 2006 (Volume 71, Number 69)]
[Notices]
[Page 18310-18311]
[DOCID:fr11ap06-79]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RP06-283-000]

Trailblazer Pipeline Company; Notice of Proposed Changes in FERC
Gas Tariff

April 4, 2006.
    Take notice that on March 31, 2006, Trailblazer Pipeline Company
(Trailblazer) tendered for filing as part of its FERC Gas Tariff, Third
Revised Volume No. 1, Fourth Revised Sheet No. 8, to become effective
May 1, 2006.
    Trailblazer states that copies of the filing are being mailed to
its customers and interested state commissions.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211 and 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed in accordance with the provisions of
section 154.210 of the Commission's regulations (18 CFR 154.210).
Anyone filing an intervention or protest must serve a copy of that
document on the Applicant. Anyone filing an intervention or protest on
or before the intervention or protest date

need not serve motions to intervene or protests on persons other than
the Applicant.
    The Commission encourages electronic submission of 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 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-5297 Filed 4-10-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 84, Number 189 (Monday, September 30, 2019)]
[Rules and Regulations]
[Pages 51405-51407]
[FR Doc No: 2019-21053]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2019-0804]
RIN 1625-AA00

Safety Zone; Grand Haven Fireworks, Lake Michigan, Grand Haven,
MI

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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SUMMARY: The Coast Guard is establishing a temporary safety zone for
navigable waters of Lake Michigan and the Grand River in Grand Haven,
MI. The safety zone is needed to protect personnel, vessels, and the
marine environment from potential hazards created by a fireworks
display. Entry of vessels or persons into this zone is prohibited
unless specifically authorized by the Captain of the Port Lake Michigan
(COTP).

DATES: This rule is effective from 7:30 p.m. on September 30, 2019,
through 9:30 p.m. on October 1, 2019.

ADDRESSES: To view documents mentioned in this preamble as being
available in the docket, go to https://www.regulations.gov, type USCG-
2019-0804 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Chief Petty Officer Kyle Weitzell, U.S. Coast Guard;
telephone<PHONE_NUMBER>, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
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

    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 the COTP received notice of the
fireworks display on September 4, 2019 and final details on September
12, 2019. Delaying the effective date of this rule to wait for a
comment period to run would be impracticable and contrary to the public
interest by inhibiting the Coast Guard's ability to protect the public,
mariners, spectators, and vessels on September 30, 2019.
    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. For the reasons discussed in the
preceding paragraph, delaying the effective date of this rule would be
impracticable because immediate action is needed to respond to the
potential safety hazards associated with a fireworks display scheduled
for September 30, 2019, with a backup date established for October 1,
2019.

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 has determined that
potential hazards associated with a fireworks display scheduled for
September 30, 2019, with a backup date established for October 1, 2019,
will be a safety concern for anyone within a 300 foot radius of the
fireworks launch site that is in close proximity to Lake Michigan and
the Grand River in Grand Haven, MI. This rule is needed to protect
personnel, vessels, and the marine environment in the navigable waters
within the safety zone immediately before, during, and following the
fireworks display.

IV. Discussion of the Rule

    This rule establishes a safety zone that will be enforced from 7:30
p.m. through 9:30 p.m. on September 30, 2019, with a rain date of 7:30
p.m. through 9:30 p.m. on October 1, 2019. The safety zone will cover
all navigable waters of Lake Michigan and the Grand River within 300
feet of the fireworks launch site at coordinates 43[deg]03.240' N,
086[deg]15.360' W.
    The duration of the zone is intended to protect personnel, vessels,
and the marine environment in these navigable waters from falling
embers and fireworks debris associated with the fireworks display.
Entry into, transiting, or anchoring within the safety zone is
prohibited unless authorized by the COTP or a designated on-scene
representative. The COTP or a designated on-scene representative may be
contacted via VHF Channel 16.

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. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. 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), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the
characteristics of the safety zone. The safety zone created by this
rule will be relatively small and is designed to minimize its impact on
navigable waters. This rule will prohibit entry into certain navigable
waters of Lake Michigan and the Grand River, Grand Haven, MI not to
exceed two hours in duration. Thus, restrictions on vessel movement
within that particular area are expected to be minimal. Under certain
conditions, moreover, vessels may still transit through the safety zone
when permitted by the COTP.

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 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. If
you believe this rule has implications for federalism or Indian tribes,
please call or email the person listed in the FOR FURTHER INFORMATION
CONTACT section above.

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 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 not more than 2
hours that will prohibit entry within 300 feet of a fireworks launch
site along Lake Michigan and the Grand River in Grand Haven, MI. It is
categorically excluded from further review under paragraph L60(a) in
Table 3-1 of U.S. Coast Guard Environmental Planning Implementing
Procedures 5090.1. A Record of Environmental Consideration supporting
this determination will be available in the docket where indicated
under ADDRESSES once it has been completed.

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. 0170.1.

0
2. Add Sec.  165.T09-0804 to read as follows:

Sec.  165.T09-0804   Safety Zone; Grand Haven Fireworks, Lake Michigan,
Grand Haven, MI.

    (a) Location. All navigable waters of Lake Michigan and the Grand
River in Grand Haven, MI within 300 feet of a fireworks launch site at
coordinates 43[deg]03.240' N, 086[deg]15.360' W.
    (b) Enforcement period. The regulated area described in paragraph
(a) will be enforced from 7:30 p.m. through 9:30 p.m. on September 30,
2019 with a rain date of 7:30 p.m. through 9:30 p.m. on October 1,
2019.
    (c) Regulations. (1) In accordance with the general regulations in
section Sec.  165.23, entry into, transiting, or anchoring within this
safety zone is prohibited unless authorized by the Captain of the Port
Lake Michigan or a designated on-scene representative.
    (2) This safety zone is closed to all vessel traffic, except as may
be permitted by the Captain of the Port Lake Michigan or a designated
on-scene representative.
    (3) The ``on-scene representative'' of the Captain of the Port Lake
Michigan is any Coast Guard commissioned, warrant or petty officer who
has been designated by the Captain of the Port Lake Michigan to act on
his or her behalf.
    (4) Vessel operators desiring to enter or operate within the safety
zone must contact the Captain of the Port Lake Michigan or an on-scene
representative to obtain permission to do so. The Captain of the Port
Lake Michigan or an on-scene representative may be contacted via VHF
Channel 16. Vessel operators given permission to enter or operate in
the safety zone must comply with all directions given to them by the
Captain of the Port Lake Michigan or an on-scene representative.

    Dated: September 23, 2019.
L.M. Lusk,
Commander, U.S. Coast Guard, Acting Captain of the Port Sector Lake
Michigan.
[FR Doc. 2019-21053 Filed 9-27-19; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register: May 2, 2006 (Volume 71, Number 84)]
[Notices]
[Page 25875-25876]
[DOCID:fr02my06-105]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-53720; File No. SR-NASD-2006-051]

Self-Regulatory Organizations; National Association of Securities
Dealers, Inc.; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change To Expand the Maximum Single Order Share Amount in Nasdaq's
INET Facility

 April 25, 2006.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 19, 2006, the National Association of Securities Dealers,
Inc.(``NASD''), through its subsidiary, the Nasdaq Stock Market, Inc.
(``Nasdaq''), submitted to the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been prepared by Nasdaq. Nasdaq filed the
proposed rule change pursuant to Section 19(b)(3)(A) of the Act \3\
which renders it effective upon filing with the Commission. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to expand the single order maximum share amount in
its INET Facility to 999,999 shares. Nasdaq will implement the proposed
rule change immediately. The text of the proposed rule change is below.
Proposed new language is in italics; deletions are in [brackets].\4\
---------------------------------------------------------------------------

    \4\ Changes are marked to the rule text that appears in the
electronic NASD Manual found at http://www.nasd.com. Prior to the

date when The NASDAQ Stock Market LLC (``NASDAQ LLC'') commences
operations, NASDAQ LLC will file a conforming change to the rules of
NASDAQ LLC approved in Securities Exchange Act Release No. 53128
(January 13, 2006).
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4953. Order Entry Parameters

    (a) INET System Orders
    (1)-(3) No Change.
    (4) Any order in whole shares up to 999,999 shares may be entered
into the System for normal execution processing.
* * * * *

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, Nasdaq included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. Nasdaq has prepared summaries, set forth in Sections A,
B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    Nasdaq's INET Facility currently operates using a 200,000 share
maximum single order limit for orders sent to the New York Stock
Exchange's DOT system. For all other orders, INET applies a 999,999
share single order maximum share amount. Nasdaq proposes to codify for
its INET Facility a maximum single order share amount standard, for all
orders, of 999,999 shares, the same share number maximum already in
place in the Nasdaq Market Center.\5\ The proposed rule change will
ensure that the INET system provides an adequate and uniform capability
to accept large-size orders as well as reduce technological complexity
for Nasdaq and users of its systems by enhancing the degree of
uniformity among single order share maximums across its systems.\6\
---------------------------------------------------------------------------

    \5\ See NASD Rule 4706(d)(1).
    \6\ The single order maximum share number limit for Nasdaq's
Brut Facility shall remain 1,000,099 shares. See NASD Rule 4903(f).
---------------------------------------------------------------------------

2. Statutory Basis
    Nasdaq believes that the proposed rule change is consistent with
Section 15A of the Act,\7\ in general, and furthers the objectives of
Section 15A(b)(6) of the Act,\8\ in particular, in that it is designed
to prevent fraudulent and manipulative acts and practices, to promote
just and equitable principles of trade, remove impediments to a free
and open market and a national market system, and, in general, to
protect investors and the public interest.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78o-3.
    \8\ 15 U.S.C. 78o-3(6).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    Nasdaq does not believe that the proposed rule change will result
in any burden on competition that is not

necessary or appropriate in furtherance of the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    Written comments were neither solicited nor received.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Nasdaq has filed the proposed rule change pursuant to Section
19(b)(3)(A) of the Act \9\ and subparagraph (f)(6) of Rule 19b-4
thereunder.\10\ Because the foregoing proposed rule change: (1) Does
not significantly affect the protection of investors or the public
interest; (2) does not impose any significant burden on competition;
and (3) does not become operative for 30 days from the date of filing,
or such shorter time as the Commission may designate if consistent with
the protection of investors and the public interest, the proposed rule
change has become effective pursuant to Section 19(b)(3)(A) of the Act
and Rule 19b-4(f)(6) thereunder. As required under Rule 19b-
4(f)(6)(iii), Nasdaq provided the Commission with written notice of its
intent to file the proposed rule change at least five business days
prior to filing the proposal with the Commission or such shorter period
as designated by the Commission. Nasdaq has requested that the
Commission waive 30-day delayed operational date provisions contained
in the above rule, based upon a representation that the proposed rule
filing would ensure that INET users have the beneficial capability to
enter larger size orders as soon as practicable. For this reason, the
Commission designates the proposal to be effective and operative upon
filing with the Commission.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A).
    \10\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml.
); or     Send an e-mail to<EMAIL_ADDRESS>Please include

File Number SR-NASD-2006-051 on the subject line.

Paper Comments

     Send paper comments in triplicate to Nancy M. Morris,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC, 20549-1090.

All submissions should refer to File Number SR-NASD-2006-051. This file
number should be included on the subject line if e-mail is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml
). Copies of the submission, all subsequent amendments, all

written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for inspection and
copying in the Commission's Public Reference Room. Copies of such
filing also will be available for inspection and copying at the
principal office of Nasdaq. All comments received will be posted
without change; the Commission does not edit personal identifying
information from submissions. You should submit only information that
you wish to make available publicly. All submissions should refer to
File Number SR-NASD-2006-051 and should be submitted on or before May
23, 2006.

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
---------------------------------------------------------------------------

    \11\ 17 CFR 200.30-3(a)(12).
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Nancy M. Morris,
Secretary.
[FR Doc. E6-6556 Filed 5-1-06; 8:45 am]

BILLING CODE 8010-01-P