[Federal Register Volume 77, Number 229 (Wednesday, November 28, 2012)]
[Notices]
[Pages 71031-71033]
[FR Doc No: 2012-28583]

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

DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

Office of Hazardous Materials Safety; Actions on Special Permit
Applications

AGENCY: Pipeline And Hazardous Materials Safety Administration (PHMSA),
DOT.

ACTION: Notice of actions on Special Permit Applications.

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

SUMMARY: In accordance with the procedures governing the application
for, and the processing of, special permits from the Department of
Transportation's Hazardous Material Regulations (49 CFR Part 107,
Subpart B), notice is hereby given of the actions on special permits
applications in (October to November 2012). The mode of transportation
involved are identified by a number in the ``Nature of Application''
portion of the table below as follows: 1--Motor vehicle, 2--Rail
freight, 3--Cargo vessel, 4--Cargo aircraft only, 5--Passenger-carrying
aircraft. Application numbers prefixed by the letters EE represent
applications for Emergency Special Permits. It should be noted that
some of the sections cited were those in effect at the time certain
special permits were issued.

    Issued in Washington, DC, on November 13, 2012.
Donald Burger,
Chief, Special Permits and Approvals Branch.

----------------------------------------------------------------------------------------------------------------
                                                                                Nature of special permit
              S.P No.                       Applicant             Regulation(s)                thereof
----------------------------------------------------------------------------------------------------------------
                                       MODIFICATION SPECIAL PERMIT GRANTED
----------------------------------------------------------------------------------------------------------------
11054-M............................  Welker Inc. Sugar       49 CFR 178.36 Subpart   To modify the special
                                      Land, TX.               C.                      permit to authorize the
                                                                                containment cylinder or
                                                                                salvage cylinder without
                                                                                the internal piston.
14546-M............................  Linde Gas North         49 CFR 180.209........  To modify the special
                                      America LLC Murray                              permit to authorize an
                                      Hill, NJ.                                       alternative testing
                                                                                procedures for
                                                                                requalifying cylinders.
3549-M.............................  Sandia National         49 CFR 172.101;         To modify the special
                                      Laboratories            173.54; 173.56;         permit to authorize the
                                      Albuquerque, NM.        173.62.                 transportation in commerce
                                                                                of additional Division 1.1
                                                                                hazardous materials.
12396-M............................  National Aeronautics    49 CFR 180.209 and      To modify the special
                                      and Space               173.302a.               permit to authorize rail
                                      Administration                                  freight, cargo vessel, and
                                      Washington, DC.                                 passenger aircraft as
                                                                                additional modes of
                                                                                operation.
14808-M............................  Amtro Alfa              49 CFR 178.51(b),       To modify the special
                                      Metalomecanica SA       (f)(1) and (2) and      permit to authorize an
                                      Portugal.               (g).                    additional 2.1 material.
15468-M............................  Prism Helicopters Inc.  49 CFR 172.101 Column   To modify the special
                                      Wasilla, AK.            (9B).                   permit to authorize the
                                                                                transportation beyond the
                                                                                state of Alaska.
----------------------------------------------------------------------------------------------------------------

                                           NEW SPECIAL PERMIT GRANTED
----------------------------------------------------------------------------------------------------------------
15334-N............................  Floating Pipeline       49 CFR 173.302a.......  To authorize the
                                      Company Incorporated                            manufacture, marking, sale
                                      Halifax, Nova Scotia.                           and use of 40' GTM (gas
                                                                                transport module)
                                                                                Intermodal Shipping
                                                                                Containers designed based
                                                                                on ASME Section VIII,
                                                                                Division 3, 2010 Edition
                                                                                for composite reinforced
                                                                                pressure vessels
                                                                                permanently fitted within
                                                                                an ISO frame. (mode 1).
15558-N............................  3M Company St. Paul,    49 CFR 173.212,         To authorize the
                                      MN.                     172.302(a)(c).          manufacture, marking,
                                                                                sale, and use of service
                                                                                motor vehicles for use in
                                                                                transporting a corrosive
                                                                                solid material in
                                                                                alternative packaging.
                                                                                (modes 1, 3).
15569-N............................  Vexxel Composites, LLC  49 CFR 173.302a(a)(1),  To authorize the
                                      Brigham City, UT.       175.3, and 180.205.     manufacture, marking,
                                                                                sale, and use of non-DOT
                                                                                specification fully-
                                                                                wrapped carbon fiber
                                                                                reinforced seamless
                                                                                stainless steel lined
                                                                                cylinders that meets all
                                                                                requirements of ISO 11119-
                                                                                2 for use in transporting
                                                                                2.2 materials. (modes 1,
                                                                                2, 3, 4, 5).
15626-N............................  EC Source Aviation,     49 CFR 49 CFR Parts     To authorize the
                                      LLC Mesa, AZ.           172.101, Column (9b),   transportation in commerce
                                                              172.204(c)(3),          of certain hazardous
                                                              173.27(b)(2),           materials by cargo
                                                              175.30(a)(1),           aircraft including by
                                                              172.200, 172.300, and   external load in remote
                                                              172.400.                areas without being
                                                                                subject to hazard
                                                                                communication requirements
                                                                                and quantity limitations
                                                                                where no other means of
                                                                                transportation is
                                                                                available. (modes 3, 4).
15658-N............................  Xcel Energy             49 CFR 173.427(b)(1),   To authorize the
                                      Monticello, MN.         173.465(c),             transportation in commerce
                                                              173.465(d).             of certain Radioactive
                                                                                material in alternative
                                                                                packaging by highway. A
                                                                                copy of the environmental
                                                                                assessment can be located
                                                                                at http://www.regulations.gov/#!documentDetail;D=PHMSA-2
                                                                                012-0165-0002 (mode 1).
15642-N............................  Praxair Distribution,   49 180.205 and          To authorize the
                                      Inc. Danbury, CT.       180.209(a)(b),          transportation in commerce
                                                              180.213(b), and         of DOT Specification 3AL
                                                              180.213(f)(2).          cylinders, cylinders
                                                                                manufactured under DOT-SP
                                                                                12440, and ISO 7866
                                                                                cylinders containing
                                                                                certain compressed gases
                                                                                when retested by a 100%
                                                                                ultrasonic examination in
                                                                                lieu of the internal
                                                                                visual and the hydrostatic
                                                                                retest. (modes 1, 2, 3, 4,
                                                                                5).
----------------------------------------------------------------------------------------------------------------
                                        EMERGENCY SPECIAL PERMIT GRANTED
----------------------------------------------------------------------------------------------------------------
15428-M............................  Space Exploration       49 CFR Part 172 and     To modify the special
                                      Technologies Corp.      173.                    permit to authorize
                                      Hawthorne, CA.                                  additional Division 2.2
                                                                                and Class 8 materials.
                                                                                (mode 1).
15729-N............................  Antonov Company, t/a    49 CFR Sec.   172.101   To authorize the one-time
                                      Antonov Airlines        Column (9B).            transportation in commerce
                                      Kiev, NH.                                       of anhydrous ammonia in
                                                                                heat pipes which is
                                                                                forbidden for
                                                                                transportation by cargo
                                                                                only aircraft. (mode 4).
15748-N............................  Wal-Mart Stores, Inc.   49 CFR part 172, part   To authorize the one-time,
                                      Bentonville, AR.        173 and part 177.       one-way transportation in
                                                                                commerce of certain
                                                                                hazardous materials from
                                                                                damaged or stucturally-
                                                                                impaired retail stores
                                                                                impacted by Hurricane
                                                                                Sandy to a temporary
                                                                                warehousing facility for
                                                                                approximately 10 miles by
                                                                                motor vehicle. (mode 1).
15751-N............................  Williams Gas Pipeline   49 CFR 177.834(h),      To authorize the use of non-
                                      White Have, PA.         178.700(c)(1).          DOT specification metal
                                                                                refueling tanks containing
                                                                                Class 3 liquids and the on
                                                                                and off loading while the
                                                                                container remains on the
                                                                                truck. (mode 1).
15691-N............................  Department of Defense   49 CFR 180.209........  To authorize the
                                      Scotts AFB, IL.                                 transportation in commerce
                                                                                of certain cylinders
                                                                                manufactured under DOT-SP
                                                                                9421 and DOT-SP 9909 that
                                                                                are passed their test date
                                                                                for requalification.
                                                                                (modes 1, 2, 3, 4).
15752-N............................  Hurricane Sandy         49 CFR 173.242 and      To authorize the
                                      Response.               Part 172 Subpart C,     transportation in commerce
                                                              Subpart D, Subpart F    of certain hazardous
                                                              and Subpart I.          materials in support of
                                                                                the recovery and relief in
                                                                                response to Hurricane
                                                                                Sandy. (mode 1).
15724-N............................  Honeywell FF & T, LLC   49 CFR 173.305(c).....  To authorize the
                                      Albuquerque, NM.                                transportation in commerce
                                                                                of certain Division 2.2
                                                                                gases in cylinders with
                                                                                openings not in the head
                                                                                or base of the cylinder.
                                                                                (mode 1) .
----------------------------------------------------------------------------------------------------------------
                                      MODIFICATION SPECIAL PERMIT WITHDRAWN
----------------------------------------------------------------------------------------------------------------
14206-M............................  Digital Wave            49 CFR 180.205........  To modify the special
                                      Corporation                                     permit to authorize ISO
                                      centennial, CO.                                 9809-2 cylinders be UE
                                                                                recertified.

13998-M............................  3AL Testing Corp.       49 CFR 172.203(a);      To modify the special
                                      Centennial, CO.         172.302a(b)(2),         permit to authorize the
                                                              (4)(5);                 ultrasonic examination of
                                                              180.205(f)(g);          ISO 9809-2 cylinders, and
                                                              180.209(a),(b)          the removal of Gulf Coast
                                                              (1)(iv).                Hydrostatic Tests as an
                                                                                agent.
----------------------------------------------------------------------------------------------------------------
                                                     DENIED
----------------------------------------------------------------------------------------------------------------
14372-M............................     Request by Kidde Aerospace and Defense Wilson, NC October 22, 2012. To
                                          modify the special permit to add additional cylinders and to allow
                                         production markings to be obliterated as part of the retest of those
                                                                      cylinders.
12102-M............................  Request by EQ Industrial Services, Inc. Ypsilanti, MI October 4, 2012. To
                                      modify the special permit to authorize
                                      additional Class 1 materials authorized to be transported as Division 4.1.
15681-N............................    Request by Micronesian Aviation Corporation dba Americopters Saipan, MP
                                       October 16, 2012. To authorize the transportation in commerce of certain
                                         hazardous materials by Part 133 Rotorcraft External Load Operations,
                                         attached to or suspended from an aircraft, in remote areas of the US
                                        without meeting certain hazard communication and stowage requirements.
15686-N............................   Request by Smoky Mountain Helicopters, Inc. Hanapepe, HI October 16, 2012.
                                      To authorize the transportation in commerce of certain hazardous materials
                                          by 14 CFR Part 133 Rotorcraft External Load Operations transporting
                                       hazardous materials attached to or suspended from an aircraft, in remote
                                          areas of the US only, without being subject to hazard communication
                                          requirements, quantity limitations and certain loading and stowage
                                                                     requirements.
15718-N............................  Request by Siex Burgos, Spain, October 16, 2012. To authorize the
                                      transportation in commerce of Division 2.2
                                      gases in non-DOT specification cylinders
15688-N............................   Request by Airborne Aviation Lihue, HI October 16, 2012. To authorize the
                                       transportation in commerce of certain hazardous materials by 14 CFR Part
                                       133 Rotorcraft External Load Operations transporting hazardous materials
                                      attached to or suspended from an aircraft, in remote areas of the US only,
                                         without being subject to hazard communication requirements, quantity
                                               limitations and certain loading and stowage requirements.
12135-M............................   Request by Daicel Safety Systems, Inc. Hyogo Prefecture 671-1681, October
                                       16, 2012. To modify the special permit to authorize a new design of non-
                                        DOT specification cylinders (pressure vessels) for use as components of
                                                          automobile vehicle safety systems.
----------------------------------------------------------------------------------------------------------------

[FR Doc. 2012-28583 Filed 11-27-12; 8:45 am]
BILLING CODE 4909-60-M


[Federal Register: July 21, 2010 (Volume 75, Number 139)]
[Proposed Rules]
[Page 42340-42342]
[DOCID:fr21jy10-17]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2010-0720; Directorate Identifier 2010-SW-050-AD]
RIN 2120-AA64

Airworthiness Directives; Sikorsky Aircraft Corporation
(Sikorsky) Model S-92A Helicopters

AGENCY: Federal Aviation Administration, DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: This document proposes adopting a new airworthiness directive
(AD) for Sikorsky Model S-92A helicopters. This proposal would require
revising the airworthiness limitations section of the Instructions

for Continued Airworthiness (ICA) to reduce the life limit of the main
gearbox housing and replacing any main gearbox housing that exceeds the
life limit. This proposal is prompted by a fatigue analysis conducted
after a helicopter was found with a severed main gearbox mounting foot
pad (foot pad) that failed due to fatigue. The actions specified by
this proposed AD are intended to prevent failure of the main gearbox
mounting housing foot pad, loss of the main gearbox, and subsequent
loss of control of the helicopter.

DATES: Comments must be received on or before September 20, 2010.

ADDRESSES: Use one of the following addresses to submit comments on
this proposed AD:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, 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.
    You may examine the comments to this proposed AD in the AD docket
on the Internet at http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Michael Schwetz, Aviation Safety
Engineer, Boston Aircraft Certification Office, 12 New England
Executive Park, Burlington, MA 01803, telephone<PHONE_NUMBER>, fax
(781) 238-7170.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to submit any written data, views, or arguments
regarding this proposed AD. Send your comments to the address listed
under the caption ADDRESSES. Include the docket number ``FAA-2010-0720,
Directorate Identifier 2010-SW-050-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of the proposed AD. We will
consider all comments received by the closing date and may amend the
proposed AD in light of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact
with FAA personnel concerning this proposed rulemaking. Using the
search function of our docket web site, you can find and read the
comments to any of our dockets, including the name of the individual
who sent or signed the comment. You may review the DOT's complete
Privacy Act Statement in the Federal Register published on April 11,
2000 (65 FR 19477-78).

Examining the Docket

    You may examine the docket that contains the proposed AD, any
comments, and other information in person at the Docket Operations
office between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The Docket Operations office (telephone<PHONE_NUMBER>) is
located in Room W12-140 on the ground floor of the West Building at the
street address stated in the ADDRESSES section. Comments will be
available in the AD docket shortly after receipt.

Discussion

    This document proposes adopting a new AD for Sikorsky Model S-92A
helicopters. This proposal would require revising the airworthiness
limitations section of the ICA to reduce the life limit of the main
gearbox housing from 2700 hours time-in-service (TIS) to 1000 hours TIS
and to replace any main gearbox housing that exceeds the lower life
limit. This proposal is prompted by review of a fatigue analysis
conducted after a helicopter was found with a severed foot pad due to
the effect of fatigue of the main gearbox housing. This condition, if
not corrected, could result in failure of the main gearbox housing
mounting foot pad, loss of the main gearbox, and subsequent loss of
control of the helicopter.
    This unsafe condition is likely to exist or develop on other
helicopters of the same type design. Therefore, the proposed AD would
require, within 60 days, revising the airworthiness limitations section
of the ICA to reduce the life limit of the main gearbox housing from
2700 hours TIS to 1000 hours TIS and replacing, before further flight,
any main gearbox housing that has exceeded the 1000-hour TIS life
limit.
    We estimate that this proposed AD would affect 15 helicopters of
U.S. registry, and the proposed actions would take about 112 work hours
per helicopter at an average labor rate of $85 per work hour. Required
parts would cost about $200,000 per helicopter. Based on these figures,
we estimate the total cost impact of the proposed AD on U.S. operators
would be $3,142,800, assuming all 15 helicopters replace the main
gearbox housing.

Regulatory Findings

    We have determined that this proposed AD would not have federalism
implications under Executive Order 13132. Additionally, this proposed
AD would not have 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.
    For the reasons discussed above, I certify that the proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a draft economic evaluation of the estimated costs to
comply with this proposed AD. See the AD docket to examine the draft
economic evaluation.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII, Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
subtitle VII, part A, subpart III, section 44701, ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Safety.

The Proposed Amendment

    Accordingly, pursuant to the authority delegated to me by the
Administrator, the Federal Aviation Administration proposes to amend
part 39 of the Federal Aviation Regulations (14 CFR part 39) as
follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. Section 39.13 is amended by adding a new airworthiness directive
to read as follows:

Sikorsky Aircraft Corporation: Docket No. FAA-2010-0720; Directorate
Identifier 2010-SW-050-AD.

    Applicability: Model S-92A helicopters, with main gearbox
housing, part number 92351-15110-042, -043, -044, or -045,
installed, certificated in any category.
    Compliance: Required as indicated, unless done previously.
    To prevent failure of the main gearbox housing mounting foot
pad, loss of the main gearbox, and subsequent loss of control of the
helicopter, do the following:
    (a) Within 60 days, revise the airworthiness limitations section
of the Instructions for Continued Airworthiness by reducing the life
limits of the affected main gearbox housing from 2700 hours time-in-
service (TIS) to 1000 hours TIS.
    (b) After revising the life limit in accordance with paragraph
(a) of this AD, before further flight, replace any main gearbox
housing that exceeds the life limit of 1000 hours TIS.
    (c) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Contact the Manager, Boston Aircraft Certification Office, FAA,
Attn: Michael Schwetz, Aviation Safety Engineer, 12 New England
Executive Park, Burlington, MA 01803, telephone<PHONE_NUMBER>, fax
(781) 238-7170, for information about previously approved
alternative methods of compliance.
    (d) The Joint Aircraft System/Component (JASC) Code is 6320:
Main Rotor Gearbox.

    Issued in Fort Worth, Texas, on July 13, 2010.
Mark R. Schilling,
Acting Manager, Rotorcraft Directorate, Aircraft Certification Service.
[FR Doc. 2010-17756 Filed 7-20-10; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 81, Number 192 (Tuesday, October 4, 2016)]
[Notices]
[Pages 68434-68435]
[FR Doc No: 2016-23931]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0376]

Dietary Supplements: New Dietary Ingredient Notifications and
Related Issues; Revised Draft Guidance for Industry; Extension of
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; extension of comment period.

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

SUMMARY: The Food and Drug Administration (FDA or we) is extending the
comment period for the revised draft guidance for industry entitled
``Dietary Supplements: New Dietary Ingredient Notifications and Related
Issues,'' that appeared in the Federal Register of August 12, 2016. We
are taking this action in response to requests to extend the comment
period to allow interested persons additional time to submit comments.

DATES: We are extending the comment period on the draft guidance
published August 12, 2016 (81 FR 53486). Submit either electronic or
written comments by December 12, 2016.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2011-D-0376 for ``Dietary Supplements: New Dietary Ingredient
Notifications and Related Issues; Revised Draft Guidance for
Industry.'' Received comments will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at http://www.regulations.gov or at the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.
     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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper 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.

FOR FURTHER INFORMATION CONTACT: Cara Welch, Office of Dietary
Supplement Programs, Center for Food Safety and Applied Nutrition (HFS-
810), Food and Drug Administration, 5001 Campus Dr., College Park, MD
20740,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In the Federal Register of August 12, 2016,
we published a notice announcing the availability of a revised draft
guidance for industry entitled ``Dietary Supplements: New Dietary
Ingredient Notifications and Related Issues.'' The revised draft
guidance, when finalized, will help industry in evaluating whether to
submit a premarket safety notification for a new dietary ingredient
(NDI), or for a dietary supplement containing an NDI, and in preparing
such premarket safety notifications (also referred to as NDI
notifications). section III of the notice (81 FR 53486 at 53489),
``Other Issues for Consideration,'' listed specific issues to be
addressed.
    The notice provided a 60-day period for the submission of comments
pertaining to the revised draft guidance, including in particular (but
not limited to) section III. Comments on these issues, the revised
draft guidance, and the relevant portions of the 2011 draft guidance,
will contribute to our final guidance on new dietary ingredient
notifications and related issues. The comment period was scheduled to
end on October 11, 2016.
    We received requests for 30- and 90-day extensions of the comment
period. In general, the requests conveyed concern that the current 60-
day comment period does not allow sufficient time for interested
parties to develop a meaningful or thoughtful response to the draft
guidance. Some requests mentioned that the requests for comment may
necessitate indepth research and/or require supporting data to provide
meaningful responses.
    We considered the requests and are extending the comment period for
the draft guidance for 60 days until December 12, 2016. We believe that
this extension allows adequate time for interested persons to submit
comments without significantly delaying finalizing the guidance.

    Dated: September 28, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-23931 Filed 10-3-16; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 190 (Monday, October 1, 2012)]
[Rules and Regulations]
[Pages 59840-59842]
[FR Doc No: 2012-24106]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

49 CFR Chapter III

Statutory Amendments Affecting Transportation of Agricultural
Commodities and Farm Supplies

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

ACTION: Notification of statutory exemptions.

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

SUMMARY: FMCSA alerts motor carriers and enforcement officials of two
statutory exemptions included in the MAP-21 transportation
reauthorization legislation that are applicable to certain motor
carriers engaged in the transportation of agricultural commodities and
farm supplies. Section 32101 of MAP-21 provides a statutory exemption
from the hours-of-service regulations for certain carriers transporting
agricultural commodities and farm supplies and section 32934 provides a
statutory exemption from most of the Federal Motor Carrier Safety
Regulations for the operation of covered farm vehicles by farm and
ranch operators, their employees, and certain other specified
individuals under certain specific circumstances. The statutory
provisions are self-executing and take effect on October 1, 2012. This
notice is intended to ensure that enforcement officials and the motor
carriers are aware of the statutory provisions. The Agency will, at a
later date, conform the FMCSRs to the statutory provisions.

DATES: The legislative provisions are effective October 1, 2012.

FOR FURTHER INFORMATION CONTACT: Mr. Thomas L. Yager, Chief, Driver and
Carrier Operations Division, Office of Bus and Truck Standards and
Operations; 1200 New Jersey Ave. SE., Washington, DC 20590, Telephone
202-366-4325, Email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    On July 6, 2012, the President signed into law ``Moving Ahead for
Progress in the 21st Century Act'' (MAP-21) (Pub. L. 112-141, 126 Stat.
405). MAP-21 included two provisions applicable to the operation of
commercial motor vehicles (CMVs) for agricultural purposes. They are
section 32101(d), ``Transportation of Agricultural Commodities and Farm
Supplies,'' and section 32934, ``Exemptions from Requirements for
Covered Farm Vehicles.''

Section 32101(d) of MAP-21

    Section 32101(d) of MAP-21 amends section 229(a)(1) of the Motor
Carrier Safety Improvement Act of 1999 [49 U.S.C. 31136 (note)] which
provides a statutory exemption from the Federal hours-of-service (HOS)
rules for commercial motor vehicle (CMV) drivers engaged in the
transportation of agricultural commodities and farm supplies.
    FMCSA's previous guidance on its HOS regulations stated that the
NHS Act agricultural operations exemption applies to the transportation
of farm supplies from the local farm retailer to the ultimate consumer
within a 100 air-mile radius. FMCSA's interpretation, however, had not
extended the HOS exemption to deliveries from wholesalers located at
port or terminal facilities to either local farm retailers or farms.
(See Question 33, 49 CFR 395.1 on the Agency's Web site:
www.fmcsa.dot.gov.) Question 33 reads as follows:
    Question 33: How is ``point of origin'' defined for the purpose of
Sec.  395.1(k)?
    Guidance: The term ``point of origin'' is not used in the NHS
Designation Act; the statutory term is ``source of the [agricultural]
commodities.'' The exemption created by the Act applies to two types of
transportation. The first type is transportation from the source of the
agricultural commodity--where the product is grown or raised--to a
location within a 100 air-mile radius of the source. The second type is
transportation from a retail distribution point of the farm supply to a
location (farm or other location where the farm supply product would be
used) within a 100 air-mile radius of the retail distribution point.
    The legislative history of the agricultural exemption indicates it
was intended to only apply to retail store deliveries. Thus, it is
clear Congress intended to limit this exemption to retail distributors
of farm supplies.
    Second-stage movements, such as grain hauled from an elevator (or
sugar beets from a cold storage facility) to a processing plant, are
more likely to fall outside the exempt radius. Similarly, the exemption
does not apply to a wholesaler's transportation of an agricultural
chemical to a local cooperative because this is not a retail

delivery to an ultimate consumer, even if it is within the 100 air-mile
radius.
    In consideration of the new statutory exemption, FMCSA withdraws
the above guidance. And through the publication of this notice and
distribution of information to the enforcement community, the Agency
will ensure the full implementation of the MAP-21 statutory exemption
on October 1, 2012.
    In addition, the Agency announces that its 2-year, limited
exemption from the Federal HOS regulations for certain carriers engaged
in the transportation of anhydrous ammonia, granted on October 6, 2010
(75 FR 61626), is no longer needed and will not be renewed. The 2-year
limited exemption covered the transportation of anhydrous ammonia from
any distribution point to a local farm retailer or the ultimate
consumer, and from a local farm retailer to the ultimate consumer, as
long as the transportation takes place within a 100 air-mile radius of
the retail or wholesale distribution point. The MAP-21 statutory
exemption addresses the needs of the carriers covered by the 2010
exemption notice.

Impact of Section 32101(d) on the States

    The statutory amendment does not, in and of itself, require any
actions by the States, at this time. However, FMCSA requests that
States immediately take action to put into place policies and
procedures to provide the regulatory relief provided by section
32101(d) of MAP-21. The Agency will amend the FMCSRs to reflect the
language in section 32101(d) and the States will be required as a
condition of receiving Motor Carrier Safety Assistance Program (MCSAP)
funding, to adopt and enforce compatible safety regulations.
    MCSAP is a Federal grant program that provides financial assistance
to States to reduce the number and severity of crashes and hazardous
materials incidents involving CMVs. The goal of the MCSAP is to reduce
CMV-involved crashes, fatalities, and injuries through consistent,
uniform, and effective CMV safety programs. The MCSAP rules (49 CFR
Part 350) include conditions for participation by States and local
jurisdictions and promote the adoption and uniform enforcement of
safety rules, regulations and standards compatible with the FMCSRs and
Federal Hazardous Materials Regulations (HMRs) for both interstate and
intrastate motor carriers and drivers.
    States are required by 49 CFR 350.331 to amend their laws and
regulations within three years after the effective date of any newly
enacted regulation or amendment to the FMCSRs or HMRs. While this
notice is not a rulemaking action amending the FMCSRs, FMCSA requests
that States immediately take action to put into place policies and
procedures to provide the regulatory relief provided by MAP-21, and to
follow up with the appropriate amendments to their laws and regulations
to reflect the statutory exemption in section 32101(d). FMCSA will
issue, at a later date, a final rule to amend the FMCSRs to reflect
this MAP-21 provision. The effective date of that rule would begin the
three-year period during which the States must adopt compatible
regulations to remain eligible for MCSAP funding.

Section 32934 of MAP-21

    Section 32934 of MAP-21 provides a statutory exemption from most of
the FMCSRs, including those pertaining to commercial driver's licenses
(CDL) and driver physical qualifications (medical) requirements, for
the operation of covered farm vehicles by farm and ranch operators,
their employees, and certain other specified individuals under specific
circumstances.
    The Agency notes the scope of the statutory exemption provided by
section 32934 is broad and its applicability may be difficult to
determine. The Agency will work with the enforcement community and
motor carriers to provide clarification, as needed, to ensure the
statutory exemption is implemented as intended by Congress. The statue
provides relief from:

 49 CFR Part 383: Commercial Driver's License Standards;
Requirements and Penalties
 49 CFR Part 382: Controlled Substances and Alcohol Use and
Testing
 49 CFR Part 391, Subpart E: Physical Qualifications and
Examinations
 49 CFR Part 395: Hours of Service
 49 CFR Part 396: Inspection, Repair and Maintenance

Which CMVs are considered covered farm vehicles?

    With regard to covered farm vehicles, the statute lists several
criteria, including a requirement that the vehicles be ``equipped with
a special license plate or other designation by the State in which the
vehicle is registered to allow for identification of the vehicle as a
farm vehicle by law enforcement personnel.'' This statutory provision
explicitly excludes farm vehicles transporting hazardous materials in
quantities requiring placards. Therefore, the absence of a ``special
license plate or other designation by the State in which the vehicle is
registered,'' or the presence of hazardous materials in a quantity
requiring placards are straightforward indicators that the farm vehicle
in question is not covered by the statutory exemption. The other
criteria require more in-depth consideration by motor carriers and
enforcement officials to determine the applicability of the exemption.
The other criteria for identifying a ``covered farm vehicle'' are
located at section 32934 of MAP-21.
    The statutory definition of covered farm vehicles may include
vehicles described above that are (1) operated pursuant to a crop share
farm lease agreement; (2) owned by a tenant with respect to that
agreement; and (3) transporting the landlord's portion of the crops
under that agreement. However, section 32934 is not applicable to the
operation of farm vehicles by for-hire motor carriers.

Relationship Between Section 32934 of MAP-21 and 49 CFR 383.3

    With regard to the CDL requirements, FMCSA notes that certain
drivers in the agricultural industry who are not covered by the MAP-21
provision, based on the statutory definition of ``covered farm
vehicle,'' may be covered by an existing regulatory exception from the
CDL requirements. As the Agency concluded in its August 15, 2011 (76 FR
50433) notice concerning the applicability of the FMCSRs to operators
of certain farm vehicles, Under 49 CFR 383.3(d), the States are
allowed, at their discretion, to provide relief from the CDL
requirements under certain specific circumstances. The regulatory
relief under section 383.3(d)(1)(iii) excludes drivers working for
commercial common or contract carriers. However, it covers drivers
transporting both the farmer's and the landlord's crops under a crop
share agreement, even if the sharecropper is specifically compensated
for performing the transportation, as the Agency made clear in its
notice of August 15, 2011 (76 FR 50433). In other words, the CDL
exemption is equally available to (1) farmers who own their land and
haul their crops to market; (2) farmers who rent their land for cash
and haul their crops to market; and (3) farmers who rent their land for
a share of the crops and haul their own and the landlord's crops to
market. These farmers continue to be eligible for the CDL exemption if
a State elects to provide the exemption.

Impact of Section 32934 on the States

    The section 32934 provision of MAP-21 includes language concerning
the impact of the statutory exemption on the States' eligibility for
Federal

transportation funding to ensure that States are not penalized for
providing regulatory relief consistent with the statutory exemption.
The statute states that ``Federal transportation funding to a State may
not be terminated, limited, or otherwise interfered with as a result of
the State exempting a covered farm vehicle, including the individual
operating that vehicle, from any State requirement relating to the
operation of that vehicle.''
    In its simplest terms, the statute makes it clear that States
adopting compatible regulations concerning motor carriers and drivers
operating covered farm vehicles in intrastate commerce must not be
penalized through the withholding of Federal transportation funding,
specifically grants associated with the FMCSA's (MCSAP) and highway
construction grants that could be withheld from States for substantial
non-compliance with the CDL.
    As indicated previously in this notice, States are required by 49
CFR 350.331 to amend their laws and regulations within three years
after the effective date of any newly enacted regulation or amendment
to the FMCSRs or HMRs. While this notice is not a rulemaking action
amending the FMCSRs, FMCSA requests that States immediately take action
to put into place policies and procedures to provide the regulatory
relief provided by MAP-21, and to follow-up with the appropriate
amendments to their laws and regulations to reflect the statutory
exemption in section 32934. FMCSA will issue, at a later date, a final
rule to amend the FMCSRs to reflect this MAP-21 provision. The
effective date of that rule would begin the three-year period during
which the States must adopt compatible regulations to remain eligible
for MCSAP funding.
    As far as the impact of section 32934 on States' CDL programs, the
statute makes clear that the U.S. Department of Transportation must not
withhold Federal-aid highway funds from a State because the State
provided exceptions or exemptions from its CDL requirements when that
relief is compatible with the language in MAP-21. Therefore, such
exceptions or exemptions will not be considered substantial non-
compliance, and section 384.301, Withholding of funds based on
noncompliance, would not be applicable in these circumstances.

Future Action

    The Agency intends to to conform the FMCSRs to the statutory
provisions. This notice is intended to ensure that all interested
parties are aware of these self-executing provisions of MAP-21 in the
interim.

    Issued on: September 26, 2012.
Anne S. Ferro,
Administrator.
[FR Doc. 2012-24106 Filed 9-27-12; 4:15 pm]
BILLING CODE 4910-EX-P


[Federal Register Volume 77, Number 40 (Wednesday, February 29, 2012)]
[Notices]
[Pages 12276-12277]
[FR Doc No: 2012-4794]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings 2

    Take notice that the Commission received the following electric
corporate filings:
    Docket Numbers: EC12-74-000.
    Applicants: AES Red Oak, L.L.C.
    Description: Section 203 Application of AES Red Oak, L.L.C.
    Filed Date: 2/21/12.
    Accession Number: 20120221-5215.
    Comments Due: 5 p.m. ET 3/13/12.

    Take notice that the Commission received the following electric
rate filings:
    Docket Numbers: ER11-3417-001; ER10-2895-004; ER11-2292-003; ER11-
3942-002; ER11-2293-003; ER10-2917-004; ER11-2294-003; ER10-2918-005;
ER12-199-003; ER10-2920-004; ER11-3941-002; ER10-2921-004; ER10-2922-
004; ER10-3048-002; ER10-2966-004.
    Applicants: Alta Wind VIII, LLC, Bear Swamp Power Company LLC,
Brookfield Energy Marketing Inc., Brookfield Energy Marketing LP,

Brookfield Energy Marketing US LLC, Brookfield Power Piney & Deep Creek
LLC, Brookfield Renewable Energy Marketing US LLC, Carr Street
Generating Station, L.P., Coram California Development, L.P., Erie
Boulevard Hydropower, L.P., Granite Reliable Power, LLC, Great Lakes
Hydro America, LLC, Hawks Nest Hydro LLC, Longview Fibre Paper and
Packaging, Inc., Rumford Falls Hydro LLC.
    Description: Non-Material Change in Status of Alta Wind VIII, LLC,
et al.
    Filed Date: 2/21/12.
    Accession Number: 20120221-5193.
    Comments Due: 5 p.m. ET 3/13/12.

    Docket Numbers: ER12-199-002.
    Applicants: Coram California Development, L.P.
    Description: Non-Material Change in Status of Coram California
Development, L.P.
    Filed Date: 2/17/12.
    Accession Number: 20120217-5208.
    Comments Due: 5 p.m. ET 3/9/12.

    Docket Numbers: ER12-1016-001.
    Applicants: Appalachian Power Company.
    Description: 20120220 Att K and L Revisions Correction to be
effective 3/2/2012.
    Filed Date: 2/21/12.
    Accession Number: 20120221-5131.
    Comments Due: 5 p.m. ET 3/13/12.

    Docket Numbers: ER12-1122-000.
    Applicants: Southwestern Public Service Company.
    Description: 2-20-12--RS135 SPS-GSEC RPSA to be effective 4/20/
2012.
    Filed Date: 2/21/12.
    Accession Number: 20120221-5133.
    Comments Due: 5 p.m. ET 3/13/12.

    Docket Numbers: ER12-1123-000.
    Applicants: ITC Midwest LLC.
    Description: Filing of Certificates of Concurrence to be effective
4/23/2012.
    Filed Date: 2/21/12.
    Accession Number: 20120221-5066.
    Comments Due: 5 p.m. ET 3/13/12.

    Docket Numbers: ER12-1124-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Original Service Agreement No. 3205; Queue No. W4-
011 to be effective 1/20/2012.
    Filed Date: 2/21/12.
    Accession Number: 20120221-5136.
    Comments Due: 5 p.m. ET 3/13/12.

    Docket Numbers: ER12-1125-000.
    Applicants: Interstate Power and Light Company.
    Description: IPL and FCW--LBA Agreement to be effective 9/24/2012.
    Filed Date: 2/21/12.
    Accession Number: 20120221-5138.
    Comments Due: 5 p.m. ET 3/13/12.

    Docket Numbers: ER12-1126-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM Original Service Agreement No. 3206; Queue No. W4-
014 to be effective 1/20/2012.
    Filed Date: 2/21/12.
    Accession Number: 20120221-5139.
    Comments Due: 5 p.m. ET 3/13/12.

    Docket Numbers: ER12-1127-000.
    Applicants: Interstate Power and Light Company.
    Description: IPL and FCW--CFC Agreement to be effective 9/24/2012.
    Filed Date: 2/21/12.
    Accession Number: 20120221-5142.
    Comments Due: 5 p.m. ET 3/13/12.

    Docket Numbers: ER12-1128-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: PJM OA Section 11.3 re Member and Affiliate
Information Updates to be effective 4/30/2012.
    Filed Date: 2/21/12.
    Accession Number: 20120221-5147.
    Comments Due: 5 p.m. ET 3/13/12.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: February 21, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-4794 Filed 2-28-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 81, Number 203 (Thursday, October 20, 2016)]
[Rules and Regulations]
[Page 72527]
[FR Doc No: 2016-25435]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2016-0946]

Drawbridge Operation Regulation; Elizabeth River, Norfolk, VA

AGENCY: Coast Guard, DHS.

ACTION: Notice of deviation from drawbridge regulation.

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

SUMMARY: The Coast Guard has issued a temporary deviation from the
operating schedule that governs the Berkley (U.S. 460/S.R. 337) Bridge
across the Elizabeth River, mile 0.4, at Norfolk, VA. The deviation is
necessary to facilitate testing of the emergency drive motors. This
deviation allows the bridge to remain in the closed-to-navigation
position.

DATES: The deviation is effective from 4 a.m. to 10 a.m. on October 30,
2016.

ADDRESSES: The docket for this deviation, [USCG-2016-0946] is available
at http://www.regulations.gov. Type the docket number in the ``SEARCH''
box and click ``SEARCH''. Click on Open Docket Folder on the line
associated with this deviation.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary deviation, call or email Mr. Mickey Sanders, Bridge
Administration Branch Fifth District, Coast Guard, telephone 757-398-
6587, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: The Virginia Department of Transportation,
who owns and operates the Berkley (U.S. 460/S.R. 337) Bridge across the
Elizabeth River, mile 0.4, at Norfolk, VA, has requested a temporary
deviation from the current operating regulation set out in 33 CFR
117.1007(b), to facilitate testing of the emergency drive motors on
both spans of the bridge.
    Under this temporary deviation, the bridge will remain in the
closed-to-navigation position from 4 a.m. to 10 a.m. on October 30,
2016. The drawbridge has two spans, each with double-leaf bascule
draws, and both spans have a vertical clearance in the closed-to-
navigation position of 48 feet above mean high water.
    The Berkley Bridge is used by recreational vessels, tug and barge
traffic, fishing vessels, and small commercial vessels. The Coast Guard
has carefully considered the nature and volume of vessel traffic on the
waterway in publishing this temporary deviation.
    Vessels able to pass through the bridges in the closed position may
do so at anytime. The bridge spans will not be able to open in case of
an emergency and there is no immediate alternate route for vessels to
pass. The Coast Guard will also inform the users of the waterway
through our Local Notice and Broadcast Notices to Mariners of the
change in operating schedule for the bridge so that vessel operators
can arrange their transits to minimize any impact caused by the
temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridges must return to
their regular operating schedule immediately at the end of the
effective period of this temporary deviation. This deviation from the
operating regulations is authorized under 33 CFR 117.35.

    Dated: October 17, 2016.
Hal R. Pitts,
Bridge Program Manager, Fifth Coast Guard District.
[FR Doc. 2016-25435 Filed 10-19-16; 8:45 am]
BILLING CODE 9110-04-P


4/ 7/ 04 1 A Varying Volume Water Body Model:

Testing and Evaluation Marietta Echeverría Office of Pesticide Programs,

Environmental Fate and Effects Division 4/ 7/ 04 2 PE4 Shell   Launches PRZM   Launches EXAMS RRA Shell   Launches PRZM   Launches VVWM EXAMS   Constant volume   Monthly parameter value variation VVWM   Volume varies   Daily parameter value variation PRZM Output File PRZM Output File Level II v 1.0 Level II v 2.0 PRZM PRZM Input File PRZM Input File 4/ 7/ 04 3 QA/ QC Testing ° Tested RRA shell for launching PRZM against the PE4 shell ° Ran all crop scenarios with RRA shell ° Compared the VVWM dissipation processes with EXAMS ° Verified the VVWM volume and overflow 4/ 7/ 04 4 EXAMS and VVWM Comparison ° FL sugarcane and CA almond crop scenarios ° Short lived ChemA and longlived ChemB ° " Standard" ecological surface water modeling scenario 4/ 7/ 04 5 Surface Water Modeling Scenarios 100 n. a.

Minimum volume ( m3) 30,000 n. a.

Maximum volume ( m3) 20,000 20,000 Initial volume ( m3) 0.01 n. a.

Minimum depth ( m) 3 n. a.

Maximum depth ( m) 2 2 Initial depth ( m) 1 1 Surface area ( ha) 10 10 Drainage area ( ha) PRZM/ VVWM PRZM/ EXAMS 4/ 7/ 04 6 CA Almond, ChemA 4/ 7/ 04 7 CA Almond, ChemB 4/ 7/ 04 8 FL Sugarcane, ChemA 4/ 7/ 04 9 FL Sugarcane, ChemB 4/ 7/ 04 10 Summary:

QA/ QC Testing ° RRA shell consistent with PE4 ° RRA shell compatible with crop scenarios and metfiles ° VVWM dissipation processes consistent with EXAMS ° VVWM volume, overflow and hydrologic washout verified 4/ 7/ 04 11 Summary:

EXAMS and VVWM Comparison ° Varying volume water body significantly effects EECs due to dilution,

evaporation and dissipation due to hydrologic washout ° Dissipation due to washout can be dominant process ° Standard modeling scenario may not be appropriate for all crop scenarios


[Federal Register Volume 77, Number 11 (Wednesday, January 18, 2012)]
[Notices]
[Pages 2555-2556]
[FR Doc No: 2012-828]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-D-0020 (formerly Docket No. 2007D-0249)]

Guidance for Industry: Preparation of Investigational Device
Exemptions and Investigational New Drug Applications for Products
Intended To Repair or Replace Knee Cartilage; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry:
Preparation of IDEs and INDs for Products Intended to Repair or Replace
Knee Cartilage'' dated December 2011. The guidance document provides
sponsors of an investigational device exemption application (IDE) or an
investigational new drug application (IND) recommendations about
certain information that should be included in

a submission describing a product intended to repair or replace knee
cartilage. The guidance does not apply to prostheses such as
unicondylar or total knee implants, or meniscus replacement products.
The guidance supplements recommendations regarding IDE and IND
submissions contained in other FDA publications. The guidance announced
in this notice finalizes the draft guidance of the same title dated
July 2007.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448; or the Division of Small Manufacturers, International, and
Consumer Assistance, Center for Devices and Radiological Health (CDRH),
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm.
4613, Silver Spring, MD 20993. Send one self-addressed adhesive label
to assist the office in processing your requests. The guidance may also
be obtained by mail by calling CBER at 1-(800) 835-4709 or (301) 827-
1800; or by calling CDRH at 1-(800) 638-2041 or by faxing a request to
CDRH at<PHONE_NUMBER>. See the SUPPLEMENTARY INFORMATION section for
electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori Jo Churchyard, Center for
Biologics Evaluation and Research (HFM-17), Food and Drug
Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-
1448,<PHONE_NUMBER>; or Elizabeth L. Frank, Center for Devices and
Radiological Health, 10903 New Hampshire Ave., Bldg. 66, rm. 1407,
Silver Spring, MD 20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Guidance for Industry: Preparation of IDEs and INDs for Products
Intended to Repair or Replace Knee Cartilage'' dated December 2011. The
guidance document provides sponsors of an IDE or an IND recommendations
about certain information that should be included in a submission
describing a product intended to repair or replace knee cartilage. The
guidance does not apply to prostheses such as unicondylar or total knee
implants, or meniscus replacement products. Human cells, tissues, and
cellular and tissue-based products (HCT/P's) regulated solely under
section 361 of the Public Health Service Act (42 U.S.C. 264) and 21 CFR
part 1271 are beyond the scope of this guidance. A product intended to
repair or replace knee cartilage may include a biologic, device, or
combination product (comprised of two or more different types of
regulated constituents) whose components would individually be
regulated by CBER and CDRH. The guidance addresses issues that may
arise in the development of articular cartilage repair or replacement
products. The guidance supplements other FDA publications on IDEs and
INDs that may be relevant to development of these products.
    In the Federal Register of July 9, 2007 (72 FR 37245), FDA
announced the availability of the draft guidance of the same title
dated July 2007. FDA received numerous comments on the draft guidance,
and those comments were considered as the guidance was finalized. In
response to comments, changes incorporated in the guidance included
adding new sections and clinical study schedules, elaborating on
nonclinical data considerations, and updating the references. In
addition, organizational and editorial changes were made to improve
clarity. Some terminology was changed to harmonize terminology within
the Agency and does not change the intent of the guidance. The guidance
also reflects input received from the public and the Cellular, Tissue,
and Gene Therapy Advisory Committee meeting held on May 15, 2009. The
guidance announced in this notice finalizes the draft guidance dated
July 2007.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    The guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
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
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; and the collections of information in 21
CFR part 812 have been approved under OMB control number 0910-0078.

III. Comments

    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. 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.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either: http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or http://www.regulations.gov.

    Dated: January 11, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-828 Filed 1-17-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 83, Number 20 (Tuesday, January 30, 2018)]
[Proposed Rules]
[Pages 4169-4171]
[FR Doc No: 2018-01742]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket Number USCG-2017-1035]
RIN 1625-AA00

Special Local Regulation; Atlantic Ocean, Miami Beach, FL

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish a recurring special
local regulation for navigable waters of the Atlantic Ocean, east of
Miami Beach, FL beginning at Government Cut Inlet, for the Miami Beach
Air and Sea Show. This action is necessary to ensure the safety of the
general public, spectators, vessels, and marine environment from
potential hazards during aerobatic maneuvers by high-speed, low-flying
airplanes and high speed vessels performing during the Miami Beach Air
and Sea Show. This proposed rulemaking would prohibit persons and non-
participant vessels from entering, transiting, anchoring in, or
remaining within the regulated area unless authorized by the Captain of
the Port Miami or a designated representative. We invite your comments
on this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before March 1, 2018.

ADDRESSES: You may submit comments on the Federal eRulemaking Portal at
http://www.regulations.gov using docket number USCG-2017-1035 in the
``Search'' feature. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Petty Officer Mara J. Brown, Sector
Miami Waterways Management Division, U.S. Coast Guard; telephone 305-
535-4317, email [email protected].

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, Purpose, and Legal Basis

    The city of Miami Beach has informed the Coast Guard it will be
hosting the Miami Beach Air and Sea Show annually over one weekend
(Saturday and Sunday) during the month of May. The special local
regulation proposed for this event would cover all navigable waters of
the Atlantic Ocean east of Miami Beach, FL beginning at Government Cut
Inlet and continuing north approximately two miles. The regulated area
is intended to protect personnel, vessels, and the marine environment
from potential hazards during aerobatic maneuvers by high speed, low
flying airplanes and high speed vessels during the air show. Over the
years, there have been unfortunate instances of aircraft mishaps during
performances at various air shows around the world. Occasionally, these
incidents result in a wide area of scattered debris in the water that
can damage property or cause significant injury or death to the public
observing the air shows. The Captain of the Port Miami has determined
that a special local regulation is necessary to protect the general
public from hazards associated with aerial flight demonstrations.
    The Coast Guard proposes this rulemaking under authority in 33
U.S.C. 1231.

III. Discussion of Proposed Rule

    This rule would establish a special local regulation over the
waters of the Atlantic Ocean east of Miami Beach, FL beginning at
Government Cut Inlet and continuing north approximately two miles. The
duration of the regulated area is intended to ensure the safety of the
aerial flight demonstrations and high speed boat races. Non participant
vessels or persons will not be permitted to enter the regulated area
without obtaining permission from the Captain of the Port or a
designated representative. The Coast Guard will provide a notice of the
regulated area by Broadcast Notice to Mariners and on-scene designated
representatives. The regulatory text we are proposing appears at the
end of this document.

IV. Regulatory Analyses

    We developed this proposed 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 NPRM has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, the NPRM 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 size,
location, duration, and time-of-day of the regulated area. Vessel
traffic will be able to safely transit around the regulated area, which
would impact a small designated area of the Atlantic Ocean. Moreover,
the Coast Guard would issue a Broadcast Notice to Mariners via VHF-FM
marine channel 16 about the zone, and the rule would allow vessels to
seek permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this
proposed rule would not have a significant economic impact on a
substantial number of small entities.
    While some owners or operators of vessels intending to transit the
regulated area may be small entities, for the reasons stated in section
IV.A above, this proposed rule would not have a significant economic
impact on any vessel owner or operator.
    If you believe your business, organization, or governmental
jurisdiction qualifies as a small entity and this rule would have a
significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    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 proposed rule. If you believe this rule
would affect your small business, organization, or governmental
jurisdiction and have questions concerning its provisions or options
for compliance, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section. The Coast Guard will not retaliate against
small entities that question or complain about this proposed rule or
any policy or action of the Coast Guard.

C. Collection of Information

    This proposed rule would 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 proposed 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 proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would 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 proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

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 proposed rule would not
result in such an expenditure, we do discuss the

effects of this rule elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, which guides the Coast Guard in complying
with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-
4370f), and have made a preliminary determination 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 proposed rule
involves a regulated area that would prohibit persons and vessels from
transiting the regulated area during the air and sea show. Normally
such actions are categorically excluded from further review under
paragraph L61 of Appendix A, Table 1 of DHS Instruction Manual 023-01-
001-01, Rev. 01. A Record of Environmental Consideration supporting
this determination will be available once we receive public comment for
this rule and will be located in the docket indicated under ADDRESSES.
We seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact 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.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacyNotice.
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.

List of Subjects in 33 CFR Part 100

    Marine safety; Navigation (water); Waterways; Reporting and
recordkeeping requirements.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

0
1. The authority citation for part 100 continues to read as follows:

    Authority: 33 .U.S.C. 1233

0
2. Add Sec.  [thinsp]100.725 to read as follows:

Sec.  [thinsp]100.725  Special Local Regulation: Miami Beach Air and
Sea Show; Atlantic Ocean, Miami Beach, FL.

    (a) Location: The following area is a regulated area located on the
Atlantic Ocean in Miami Beach, FL. All waters of the Atlantic Ocean
encompassed within an imaginary line connecting the following points:
Starting at Point 1 in position 25[deg]47'52'' N, 080[deg]6'55'' W;
thence southwest to Point 2 in position 25[deg]45'40'' N, 080[deg]
7'16'' W; thence northwest to Point 3 in position 25[deg]45'50'' N,
080[deg]07'49'' W; thence north to Point 4 in position 25[deg]47'56''
N,080[deg]07'30'' W; thence back to the origin at Point 1. These
coordinates are based on North American Datum 1983. All persons and
vessels, except those persons and vessels participating in the event,
are prohibited from entering, transiting, anchoring in, or remaining
within the regulated area.
    (b) Definitions: (1) The term ``designated representative'' means
Coast Guard Patrol Commanders, including Coast Guard coxswains, petty
officers, and other officers operating Coast Guard vessels, and
Federal, State, and Local officers designated by or assisting the
Captain of the Port Miami in the enforcement of the regulated areas.
    (2) The term ``Patrol Commander'' means a commissioned, warrant, or
petty officer of the Coast Guard who has been designated by the
respective Coast Guard Sector Commander to enforce these regulations.
    (3) The term ``spectators'' means all persons and vessels not
registered with the event sponsor as participants or official patrol
vessels.
    (c) Regulations: (1) All non-participant vessels or persons are
prohibited from entering, transiting, anchoring in, or remaining within
the regulated area unless authorized by the Captain of the Port or a
designated representative.
    (2) Persons and vessels desiring to enter, transit, anchor in, or
remain within the regulated area may contact the Captain of the Port
Miami by telephone at<PHONE_NUMBER> or a designated representative via
VHF-FM radio on channel 16, to request authorization. If authorization
is granted, all persons and vessels receiving such authorization must
comply with the instructions of the Captain of the Port Miami or a
designated representative.
    (3) The Coast Guard will notify the public in advance of the event
contained in these regulations by publishing a Notice of Enforcement in
the Federal Register in advance of the date of the event. In addition,
the Coast Guard will issue a Broadcast Notice to Mariners via VHF-FM
channel 16, or provide notice by on-scene designated representatives.
    (d) Enforcement period: This rule will be enforced annually on a
weekend (Saturday and Sunday) during the month of May.

    Dated: January 16, 2018.
M.M. Dean,
Captain, U.S. Coast Guard, Captain of the Port Miami.
[FR Doc. 2018-01742 Filed 1-29-18; 8:45 am]
 BILLING CODE 9110-04-P