[Federal Register Volume 79, Number 99 (Thursday, May 22, 2014)]
[Notices]
[Pages 29436-29437]
[FR Doc No: 2014-11861]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP07-52-000; Docket Nos. CP07-53-000; CP07-53-001]

Downeast LNG, Inc., Downeast Pipeline, LLC; Notice of
Availability of the Final Environmental Impact Statement for the
Proposed Downeast LNG Project

    The staff of the Federal Energy Regulatory Commission (FERC or
Commission) has prepared a final environmental impact statement (EIS)
for the Downeast LNG Project, proposed by Downeast LNG, Inc. and
Downeast Pipeline, LLC (collectively Downeast) in the above-referenced
dockets. Downeast requests authorization to construct and operate a
proposed liquefied natural gas (LNG) import terminal, natural gas
sendout pipeline, and associated facilities in Washington County,
Maine. The Downeast LNG Project would provide about 500 million cubic
feet per day of imported natural gas to the New England region.
    The final EIS assesses the potential environmental effects of the
construction and operation of the Downeast LNG Project in accordance
with the requirements of the National Environmental Policy Act (NEPA).
The FERC staff concludes that approval of the proposed project, with
the mitigation measures recommended in the EIS, would ensure that most
impacts in the project area would be avoided or reduced to less than
significant levels. Construction and operation of the project would
primarily result in temporary and short-term environmental impacts;
however, some long-term and permanent environmental impacts would
occur.
    The U.S. Coast Guard; U.S. Army Corps of Engineers; National
Oceanic and Atmospheric Administration, National Marine Fisheries
Service; U.S. Environmental Protection Agency; U.S. Department of
Transportation; and the Maine Department of Environmental Protection
participated as cooperating agencies in the preparation of the EIS.
Cooperating agencies have jurisdiction by law or special expertise with
respect to resources potentially affected by the proposal and
participate in the NEPA analysis. Although the cooperating

agencies provided input to the conclusions and recommendations
presented in the EIS, the agencies will present their own conclusions
and recommendations in their respective Records of Decision or other
determinations for the project.
    The final EIS addresses the potential environmental effects of the
construction and operation of the following project facilities:
     A new marine terminal that would include a 3,862-foot-long
pier with a single berth and vessel mooring system, intended to handle
LNG vessels ranging from 70,000 to 165,000 cubic meters in capacity,
with future expansion capabilities to handle vessels with 220,000 cubic
meters of cargo capacity;
     two full-containment LNG storage tanks, each with a
nominal usable storage capacity of 160,000 cubic meters;
     LNG vaporization and processing equipment;
     piping, ancillary buildings, safety systems, and other
support facilities;
     three vapor fences around the LNG terminal;
     a 29.8-mile-long, 30-inch-diameter underground natural gas
pipeline;
     natural gas metering facilities located at the LNG
terminal site; and
     various ancillary facilities including pigging \1\
facilities and three mainline block valves.
---------------------------------------------------------------------------

    \1\ A ``pig'' is a tool for cleaning and inspecting the inside
of a pipeline.
---------------------------------------------------------------------------

    The FERC staff mailed copies of the EIS to Federal, state, and
local government representatives and agencies; elected officials;
environmental and public interest groups; Native American tribes;
potentially affected landowners and other interested individuals and
groups; newspapers and libraries in the project area; and parties to
this proceeding.
    Everyone on our environmental mailing list will receive a CD
version of the final EIS. Paper copy versions of the EIS were mailed to
those specifically requesting them. Only volume 1 of the final EIS,
containing text of the analysis, was printed in hard copy. Volume 2,
containing additional appendices, was produced as .pdf files on a CD.
Responses to comments received on the draft EIS and Supplemental draft
EIS are included in Appendix S and T, respectively. In addition, the
EIS is available for public viewing on the FERC's Web site
(www.ferc.gov) using the eLibrary link. A limited number of copies are
available for distribution and public inspection at: Federal Energy
Regulatory Commission, Public Reference Room, 888 First Street NE.,
Room 2A, Washington, DC 20426,<PHONE_NUMBER>.
    Additional information about the project is available from the
Commission's Office of External Affairs, at (866) 208-FERC, or on the
FERC Web site (www.ferc.gov) using the eLibrary link. Click on the
eLibrary link, click on ``General Search,'' and enter the docket number
excluding the last three digits in the Docket Number field (i.e., CP07-
52 or CP07-53). Be sure you have selected an appropriate date range.
For assistance, please contact FERC Online Support at
<EMAIL_ADDRESS>or toll free at<PHONE_NUMBER>; for TTY,
contact<PHONE_NUMBER>. The eLibrary link also provides access to the
texts of formal documents issued by the Commission, such as orders,
notices, and rulemakings.
    In addition, the Commission offers a free service called
eSubscription which allows you to keep track of all formal issuances
and submittals in specific dockets. This can reduce the amount of time
you spend researching proceedings by automatically providing you with
notification of these filings, document summaries, and direct links to
the documents. Go to www.ferc.gov/docs-filing/esubscription.asp.

    Dated: May 15, 2014.
Kimberly D. Bose,
Secretary.
[FR Doc. 2014-11861 Filed 5-21-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 5, 2009 (Volume 74, Number 149)]
[Rules and Regulations]
[Page 38974-38985]
[DOCID:fr05au09-23]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 599

[ Docket No. NHTSA-2009-0120]
RIN 2127-AK54; Notice 1

Requirements and Procedures for Consumer Assistance To Recycle
and Save Program

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

ACTION: Final rule.

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

SUMMARY: This final rule amends the regulation implementing the
Consumer Assistance to Recycle and Save (CARS) Program, published on
July 29, 2009 in the Federal Register, under the CARS Act (Pub. L. 111-
32). The rule clarifies the insurance eligibility requirements for
trade-in vehicles under the CARS program. The rule makes substantive
changes and a conforming amendment related to the timing for disabling
trade-in vehicle engines. The rule also makes a technical amendment to
the requirements and procedures for identifying salvage auctions and
disposal facilities. Finally, we provide a clarification related to the
insurance requirement under the CARS Act.

DATES: This final rule is effective August 5, 2009. Petitions: If you
wish to petition for reconsideration of this rule, your petition must
be received by September 21, 2009.

ADDRESSES: If you submit a petition for reconsideration of this rule,
you should refer in your petition to the docket number of this document
and submit your petition to: Administrator, National Highway Traffic
Safety Administration, 1200 New Jersey Avenue, SE., West Building,
Washington, DC 20590.
    The petition will be placed in the public docket. Anyone is able to
search the electronic form of all documents received into any of our
dockets by the name of the individual submitting the document (or
signing the document, if submitted on behalf of an association,
business, labor union, etc.). You may review the complete User Notice
and Privacy Notice for Regulations.gov at http://www.regulations.gov/
search/footer/privacyanduse.jsp.

FOR FURTHER INFORMATION CONTACT: For questions, you may call David
Bonelli, NHTSA Office of Chief Counsel, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: This final rule amends the regulation
implementing the Consumer Assistance to Recycle and Save (CARS)
Program, published on July 29, 2009 (74 FR 37878), under the CARS Act
(Pub. L. 111-32). The rule makes substantive changes and a conforming
amendment related to the timing for disabling trade-in vehicle engines.
The rule also makes a technical amendment to the requirements and
procedures for identifying salvage auctions and disposal facilities.
Finally, the agency clarifies the application of the insurance
requirement under the CARS Act.

a. Engine Disablement

    The rule currently requires a dealer that receives an eligible
trade-in vehicle under the CARS program to disable that vehicle's
engine prior to submitting an application for reimbursement and prior
to transferring the vehicle to a disposal facility. That requirement is

implemented in sections 599.300(a), 599.300(d)(2), 599.300(e)(1)(i) and
the certifications in Appendix A.
    The agency has determined that the requirement for a dealer to
disable the engine prior to submitting an application for reimbursement
could create an undue hardship for a dealer in some circumstances. For
example, a dealer operating in good faith may conduct a non-compliant
transaction under the CARS program and extend a credit that is
disapproved for reimbursement after the sale or lease of a new vehicle
to a customer. If the engine of the trade-in vehicle has already been
disabled under these circumstances, as the rule currently requires, the
dealer would not only forgo a CARS credit reimbursement, but also be
unable to recoup the full value of the trade-in vehicle to mitigate its
loss.
    With these considerations in mind, this final rule amends the
provision relating to the timing of the dealer's disablement of the
engine of the trade-in vehicle. The agency is removing the requirement
that the dealer disable the engine prior to submitting an application
for reimbursement and replacing it with a provision that allows engine
disablement before or after submission of the application for
reimbursement, but in all cases prior to leaving the dealership or
property owned by or under the control of the dealership.
    Accordingly, we are amending section 599.300(a) to specify that the
dealer must store the trade-in vehicle at the dealership or property
owned by or under the control of the dealership until the engine is
disabled. We are amending section 599.300(d) to remove the requirement
for engine disablement prior to submission of the request for
reimbursement and to insert a requirement that the dealer must disable
the engine at its dealership or property owned by or under the control
of the dealership not more than seven calendar days after the
government reimburses the dealer for the value of the credit. The
continued storage of the trade-in vehicle and the disablement of trade-
in vehicle's engine are conditions of the government's payment of the
credit to the dealer that the dealer is obligated to satisfy.
    We are amending the certification in Appendix A to allow a dealer
to certify, at the time of the submission of the application for
reimbursement, that the dealer has either already disabled the engine
at the dealership or property owned by or under the control of the
dealership or will store the trade-in vehicle at the dealership or
property owned by or under the control of the dealership and disable
the engine at the dealership or property owned by or under the control
of the dealership not more than seven calendar days after receiving
electronic reimbursement for the credit. The amendment does not change
the requirement that the dealer disable the engine before the trade-in
vehicle is transferred to the disposal facility or salvage auction. The
storage requirement enables the agency to inspect to see that the
dealer has not shipped the trade-in vehicle prematurely. The rule makes
a conforming change section 599.300(d)(3) to retain the requirement to
mark the title prior to submission of the application for
reimbursement. Finally, today's amendments do not affect the
requirements for pre-July 24th trade-in vehicles under the program
where the vehicle has already been transferred from the dealership.

b. Technical Amendments

    The final rule currently requires salvage auctions, as a condition
of participation in the program, to transfer trade-in vehicles only to
a disposal facility listed on the agency's website at cars.gov/disposal
or to a facility that disposes of vehicles in Puerto Rico, the Virgin
Islands, Guam, American Samoa, or the Commonwealth of the Northern
Mariana Islands. Section 599.201(a)(1) of the regulation incorrectly
stated that a salvage auction may transfer the vehicle to a disposal
facility identified in Section 599.201(b)(2) or (b)(3). The correct
citations are Section 599.201(a)(2) or (a)(3). Today's amendment makes
that correction.
    The agency is amending the Dealer Certifications (Appendix A). We
are removing the reference to the ``engine block'' and replacing it
with the ``engine'' for conformity with the language in the regulation.
In this same dealer certification, the phrase ``render inoperative'' is
being replaced with the word ``disable.'' This change, too, allows the
dealer certification form in Appendix A to conform to the language used
throughout the rule. These changes do not change the meaning of the
rule. The procedures of Appendix B, Engine Disablement Procedures for
the CARS Program, continue to apply. These dealer certification changes
will also be made to the electronic certification screen a dealer sees
while entering a transaction. It may take some time to amend the
electronic form. However, the new certifications are now available in
the Summary of Sale sheet, which should be used immediately. The
certifications on this form will control and the superseded
certification on the electronic form will not be binding.
    Finally, the agency is amending the Disposal Facility Certification
Form (Appendix E) by replacing incorrect information in one of the
input fields. We are removing ``End of Life Vehicle Solution (ELVS)
Identification No. (if assigned)'' and replacing it with ``NHTSA
Disposal Facility Identification No. (if assigned).'' The requested
number is a unique identifier assigned by NHTSA to the disposal
facility identified on the CARS website--it is not assigned by the ELVS
program. This correction should resolve the instances of misdirected
inquiries from dealers seeking a number from the ELVS program.

c. Insurance Eligibility Requirements

    In addressing the requirement under the CARS Act that the trade-in
vehicle be ``continuously insured consistent with the applicable State
law,'' the agency stated in the preamble to the rule its interpretation
that the Act requires all transactions to meet the continuous one-year
insurance condition as a threshold matter with respect to any trade-in
vehicle under the CARS program. Upon further consideration of the
statutory language and because the prior interpretation has only been
in effect a few days, the agency has concluded that, in those States
with no insurance requirement, the rule's requirement unfairly
penalizes consumers who are in compliance with State law. Therefore,
today's interpretation exempts trade-in vehicles registered in New
Hampshire and Wisconsin from the one-year insurance requirement because
both New Hampshire and Wisconsin have no insurance requirement under
State Law. As this interpretation is not inconsistent with the existing
regulatory text, no change to the rule is necessary; however, the
dealer and purchaser certifications (Appendix A) are being amended to
make today's interpretation clear.

Statutory Basis for This Action

    This final rule makes amendments to implement the Consumer
Assistance to Recycle and Save Act (CARS Act) (Pub. L. 111-32), which
directs the Secretary to issue final regulations.

APA Requirements and Effective Date

    The rule is being issued without first providing a notice and an
opportunity for public comment. Section 1302(d) of the CARS Act
provides that ``notwithstanding'' the requirements of section 553 of
title 5, United States Code, the Secretary shall promulgate

final regulations to implement the Program not later than 30 days after
the date of the enactment of this Act. Given that schedule and the fact
that this 4-month program with a statutorily fixed end date has already
begun, the agency finds for good cause that providing notice and
comment is impracticable and contrary to the public interest for these
changes to the final rule. Drafting and issuing a proposed rule,
providing a period for public comment, and addressing those comments in
the final rule would have been highly impracticable in the time
available and would have substantially delayed issuance of this final
rule. Because sales of new vehicles under the program have begun in
what appears to be high volume, we believe it is necessary to provide
these amendments and clarification immediately so that no one will be
harmed in making transactions.
    Because of the CARS Act schedule and the fact that the 4-month
program has already begun, the agency finds that it has good cause to
make this rule effective fewer than 30 days after the publication in
the Federal Register. In view of the fact that sales of new vehicles
under the program have begun in what appears to be high volume, we
believe it is necessary to provide these amendments and clarifications
immediately so that no one will be harmed in making transactions. We
also note that, other than the technical provisions, this rule is
relieving restrictions in the original final rule. It would, therefore,
be inconsistent with Congressional intent, impracticable, and contrary
to the public interest, to delay the effective date of the regulation,
which would, in turn, adversely affect effective implementation of the
program.
    Accordingly, the effective date of this final rule is August 5,
2009.

Regulatory Analyses and Notices

    Because of the public and Congressional interest in the CARS
program, this rulemaking is considered significant under Executive
Order 12866 and the Department of Transportation's Regulatory Policies
and Procedures. It was reviewed by the Office of Management and Budget.
The agency has discussed the relevant requirements of the Regulatory
Flexibility Act, Executive Order 13132 (Federalism), Executive Order
12988 (Civil Justice Reform), the National Environmental Policy Act,
the Paperwork Reduction Act, and the Unfunded Mandates Reform Act in
the July 29, 2009 final rule cited above. This rule does not change the
finding in those analyses.
Regulatory Identifier Number (RIN)
    The Department of Transportation assigns a regulatory identifier
number (RIN) to each regulatory action listed in the Unified Agenda of
Federal Regulations. The Regulatory Information Service Center
publishes the Unified Agenda in April and October of each year. You may
use the RIN contained in the heading at the beginning of this document
to find this action in the Unified Agenda.
Privacy Act
    Please note that anyone is able to search the electronic form of
all comments received into any of our dockets by the name of the
individual submitting the comment (or signing the comment, if submitted
on behalf of an association, business, labor union, etc.). You may
review the complete User Notice and Privacy Notice for Regulations.gov
at http://www.regulations.gov/search/footer/privacyanduse.jsp.

List of Subjects in 49 CFR Part 599

    Fuel Economy, Motor Vehicle Safety.

0
In consideration of the foregoing, NHTSA hereby amends 49 CFR part 599
as set forth below.

PART 599--REQUIREMENTS AND PROCEDURES FOR CONSUMER ASSISTANCE TO
RECYCLE AND SAVE ACT PROGRAM

0
1. The authority citation for Part 599 continues to read as follows:

    Authority:  49 U.S.C. 32901, Notes; delegation of authority at
49 CFR 1.50.

0
2. Section 599.201 is amended by revising paragraph (a)(1) to read as
follows:

Sec.  599.201  Identification of salvage auctions and disposal
facilities.

    (a) * * *
    (1) A salvage auction that will transfer trade-in vehicles received
under this program only to a disposal facility identified in paragraph
(a)(2) or (a)(3) of this section.
* * * * *

0
3. Section 599.300 is amended by revising paragraphs (a), (d)
introductory text, (d)(2), and (d)(3), to read as follows:

Sec.  599.300  Requirements for qualifying transactions.

    (a) In general. To qualify for a credit under the CARS Program, a
dealer must sell or lease a new vehicle that meets eligibility
requirements to a purchaser, obtain a trade-in vehicle that meets
eligibility requirements from the purchaser, satisfy combined fuel
economy requirements for both the new and trade-in vehicles, store the
trade-in vehicle at the dealership or property owned by or under the
control of the dealership until the engine is disabled, disable the
engine of the trade-in vehicle at the dealership or property owned by
or under the control of the dealership, satisfy the limitations and
restrictions of the program, arrange for disposal of the trade-in
vehicle at a qualifying disposal facility or through a qualifying
salvage auction, and register and submit a complete application for
reimbursement to NHTSA, demonstrating that it meets all the
requirements of this part.
* * * * *
    (d) Trade-In Vehicle--Disclosure of Scrap Value, Engine
Disablement, and Title Marking. As part of a qualifying transaction
under this part, the dealer shall:
* * * * *
    (2) Except as provided in paragraph (e) of this section, store the
trade-in vehicle at the dealership or property owned by or under the
control of the dealership until its engine is disabled following the
procedures set forth in Appendix B to this part, disable the engine of
the trade-in vehicle at the dealership or property owned by or under
the control of the dealership following the procedures set forth in
Appendix B to this part, and certify, as provided in Appendix A to this
part, dealer certifications section, that either the engine of the
trade-in vehicle has been disabled at the dealership or property owned
by or under the control of the dealership, or that the trade-in vehicle
will be stored at the dealership or property owned by or under the
control of the dealership until the engine is disabled and the engine
of the trade-in vehicle will be disabled by the dealer at the
dealership or property owned by or under the control of the dealership
not more than seven calendar days after the dealer's receipt of payment
for the transaction; and
    (3) Prior to submitting an application for reimbursement under
Sec.  599.302, legibly mark the front and back of the trade-in
vehicle's title in prominent letters that do not obscure the owner's
name, VIN, or other writing as follows: ``Junk Automobile, CARS.gov.''
* * * * *

0
4. Revise Appendix A to Part 599 to read as follows:
BILLING CODE 4910-59-P

[GRAPHIC] [TIFF OMITTED] TR05AU09.015

[GRAPHIC] [TIFF OMITTED] TR05AU09.016

[GRAPHIC] [TIFF OMITTED] TR05AU09.017

[GRAPHIC] [TIFF OMITTED] TR05AU09.018

[GRAPHIC] [TIFF OMITTED] TR05AU09.019

0
5. Revise Appendix E to Part 599 to read as follows:

[GRAPHIC] [TIFF OMITTED] TR05AU09.020

[GRAPHIC] [TIFF OMITTED] TR05AU09.021

[GRAPHIC] [TIFF OMITTED] TR05AU09.022

    Issued on: July 31, 2009.
Ronald L. Medford,
Acting Deputy, Administrator.
 [FR Doc. E9-18835 Filed 8-3-09; 4:15 pm]

BILLING CODE 4910-59-C


 [Federal Register: October 23, 2009 (Volume 74, Number 204)] [ Proposed Rules]                [Page 54771-54773] [DOCID:fr23oc09-15]

=======================================================================

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 514

[Docket No. FDA-2009-N-0436]

  New Animal Drug Applications

AGENCY: Food and Drug Administration, HHS.

ACTION:  Proposed rule.

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

SUMMARY: The Food and Drug Administration (FDA) is proposing to amend

the regulations regarding new animal drug applications (NADAs).

Specifically, this proposed rule is being issued to provide that NADAs

shall be submitted in the form and containing the information

described, as appropriate for the particular submission. Currently, the

regulation requires that all NADAs contain the same informational

sections and does not explicitly provide the appropriate flexibility

needed to address the development of all types of new animal drug

products. This amendment will allow the agency to appropriately review

safety and effectiveness data submitted to support the approval of new

animal drug products. This proposed rule is a companion document to the

direct final rule published elsewhere in this issue of the Federal

Register.

DATES: Submit written comments on or before January 6, 2010. If FDA

receives any significant adverse comments, the agency will publish a

document withdrawing the direct final rule within 30 days after the

comment period ends. FDA will then proceed to respond to comments under

this proposed rule using the usual notice and comment procedures.

ADDRESSES: You may submit comments, identified by Docket No. FDA-2009-

N-0436 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.

    To ensure more timely processing of comments, FDA is no longer

accepting

comments submitted to the agency by e-mail. FDA encourages you to

continue to submit electronic comments by using the Federal eRulemaking

Portal, as described previously, in the ADDRESSES portion of this

document under Electronic Submissions.

    Instructions: All submissions received must include the agency name

and Docket No. 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.

FOR FURTHER INFORMATION CONTACT:  Urvi Desai, Center for Veterinary

Medicine (HFV-100), Food and Drug Administration, 7500 Standish Pl.,

Rockville, MD 20855,<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION:

I. Background

    This proposed rule is being issued to amend Sec.  514.1 (21 CFR

514.1) so as to provide that NADAs shall contain the information

described in the section, as appropriate for the particular submission.

Currently, the regulation requires that all NADAs contain the same

informational sections and does not explicitly provide the appropriate

flexibility needed to address the development of all types of new

animal drug products. This amendment will allow the agency to

appropriately review safety and effectiveness data submitted to support

the approval of new animal drug products. In addition, the proposed

amendment is similar to the current provisions of the human new drug

application regulations at 21 CFR 314.50 and thus will make the new

human and new animal drug regulations more consistent.

II. Companion Document to Direct Final Rulemaking

    This proposed rule is a companion to the direct final rule

published in the final rules section of this issue of the Federal

Register. The direct final rule and this companion proposed rule are

substantively identical. This companion proposed rule provides the

procedural framework to finalize the rule in the event that a

significant adverse comment is received in response to the direct final

rule and it is withdrawn. FDA is publishing the direct final rule

because we believe the rule is non-controversial, and we do not

anticipate receiving any significant adverse comments. If no

significant adverse comment is received in response to the direct final

rule, no further action will be taken related to this proposed rule.

Instead we will publish a document confirming the effective date within

30 days after the comment period ends, confirming when the direct final

rule will go into effect.

    If we receive any significant adverse comment regarding the direct

final rule, we will withdraw the direct final rule within 30 days after

the comment period ends and proceed to respond to all of the comments

under this companion proposed rule using usual notice-and-comment

rulemaking procedures under the Administrative Procedures Act (APA) (5

U.S.C. 552a et seq.). The comment period for this companion proposed

rule runs concurrently with the comment period for the direct final

rule. Any comments received under this companion proposed rule will

also be considered as comments regarding the direct final rule, and

vice versa. We will not provide additional opportunity for comment.

    A significant adverse comment is defined as a comment that explains

why the rule would be inappropriate, including challenges to the rule's

underlying premise or approach, or would be ineffective or unacceptable

without a change. In determining whether an adverse comment is

significant and warrants withdrawing a direct final rule, we will

consider whether the comment raises an issue serious enough to warrant

a substantive response in a notice-and-comment process in accordance

with section 553 of the APA (5 U.S.C. 553). Comments that are

frivolous, insubstantial, or outside the scope of the rule will not be

considered adverse under this procedure. For example, a comment

recommending an additional change to the rule will not be considered a

significant comment unless the comment states why the rule would be

ineffective without the additional change. In addition, if a

significant adverse comment applies to part of a rule and that part can

be severed from the remainder of the rule, we may adopt as final those

parts of the rule that are not the subject of a significant adverse

comment.

    In the Federal Register of November 21, 1997 (62 FR 62466), you can

find additional information about FDA's direct final rulemaking

procedures in the guidance document entitled ``Guidance for FDA and

Industry: Direct Final Rule Procedures.'' This guidance document may be

accessed at http://www.fda.gov/RegulatoryInformation/Guidances/

ucm125166.htm.

III. Legal Authority

    FDA's authority to issue this proposed rule is provided by section

512(b)(1) of the Federal Food, Drug, and Cosmetic Act (the act) (21

U.S.C. 360b(b)(1)). This section states that any person may file with

the Secretary of Health and Human Services an application with respect

to any intended use or uses of a new animal drug and sets forth the

specific information that must be included in such an application. In

addition, section 701(a) of the act (21 U.S.C. 371(a)) gives FDA

general rulemaking authority to issue regulations for the efficient

enforcement of the act. FDA is issuing this proposed rule under these

authorities.

IV. Environmental Impact

    FDA has carefully considered the potential environmental impacts of

this rule and determined 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.

V. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive

Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and

the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive

Order 12866 directs 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). The agency believes that

this proposed rule is not a significant regulatory action under the

Executive order.

    The Regulatory Flexibility Act requires agencies to analyze

regulatory options that would minimize any significant impact of a rule

on small entities. Because the proposed rule would not impose any

direct or indirect costs on industry or government through the

amendment, but rather

would only clarify that sponsors must include in their applications the

information described in Sec.  514.1 that is appropriate for their

particular submission, the agency proposes to certify that the 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 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 $133 million, using the most current (2008) Implicit

Price Deflator for the Gross Domestic Product. FDA does not expect this

proposed rule to result in any 1-year expenditure that would meet or

exceed this amount.

VI. Federalism

    FDA has analyzed this proposed 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. Paperwork Reduction Act of 1995

    This proposed rule refers to previously approved collections of

information found in FDA regulations. The proposed rule would amend

these previously approved collections of information by clarifying that

NADAs must contain the information appropriate for the particular

submission. Further, this amendment is based upon the Center for

Veterinary Medicine's previous experience with these submissions. Thus,

Sec.  514.1, as amended, does not constitute a new or additional

paperwork burden requiring Office of Management and Budget (OMB)

approval.

    Collections of information are subject to review by OMB under the

Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections

of information in Sec.  514.1 have been approved under OMB Control No.

0910-0032.

VIII. Request for Comments

    Interested persons may submit to the Division of Dockets Management

(see ADDRESSES) written or electronic comments regarding this document.

Submit a single copy of electronic comments or two paper copies of any

mailed comments, except that individuals may submit one paper copy.

Comments are to be identified 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 514

    Administrative practice and procedure, Animal drugs, Confidential

business information, Reporting and recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, it is

proposed that 21 CFR part 514 be amended as follows:

PART 514--NEW ANIMAL DRUG APPLICATIONS

    1. The authority citation for 21 CFR part 514 continues to read as

follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 356a, 360b, 371, 379e,

381.

    2. In Sec.  514.1, revise the first sentence of paragraph (a) and

the introductory text of paragraph (b) to read as follows:

Sec.  514.1  Applications.

    (a) Applications to be filed under section 512(b) of the act shall

be submitted in the form and contain the information described in

paragraph (b) of this section, as appropriate to support the particular

submission. * * *

    (b) Applications for new animal drugs shall be submitted in

triplicate and assembled in the manner prescribed by paragraph (b)(15)

of this section, and shall include the following information, as

appropriate to support the particular submission: * * *

* * * * *

    Dated: October 19, 2009.

David Horowitz,

Assistant Commissioner for Policy.

[FR Doc. E9-25518 Filed 10-22-09; 8:45 am]

BILLING CODE 4160-01-S


Name of Firm:________________________________________________________________ Date and Location of Renovation:_________________________________________________ Name of Assigned Renovator:____________________________________________________

Copies of renovator qualifications ( training certificates, certifications) on file.

Name of Dust Sampling Technician, Inspector, or Risk Assessor, if used:_________________ ____________________________________________________________________________

Copies of sampling personnel qualifications ( training certificates, certifications) on file.

Name( s) of Trained Workers:____________________________________________________ ____________________________________________________________________________

Description of Tasks Performed by Trained Workers:_________________________________ ____________________________________________________________________________

Description of Training Provided to Workers by Renovator:____________________________ ____________________________________________________________________________

Warning signs posted.

Description of work area and containment practices used:______________________________ ____________________________________________________________________________ ____________________________________________________________________________ Description of how waste was handled:_____________________________________________ ____________________________________________________________________________ Description of how walls, floors, and other surfaces and objects in the work area were cleaned: ____________________________________________________________________________ ____________________________________________________________________________ Description of post renovation cleaning verification process:____________________________ ____________________________________________________________________________ ____________________________________________________________________________ Description of dust clearance testing, if performed:___________________________________ ____________________________________________________________________________ ____________________________________________________________________________ ____________________________________________________________________________

I certify under penalty of law that the above information is true and complete.

____________________________________________ ______________________ name date ____________________________________________ title


[Federal Register Volume 86, Number 47 (Friday, March 12, 2021)]
[Notices]
[Pages 14130-14131]
[FR Doc No: 2021-05103]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-2197]

VistaPharm, Inc., et.al.; Withdrawal of Approval of 10
Abbreviated New Drug Applications; Correction

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; correction.

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

SUMMARY: The Food and Drug Administration (FDA) is correcting a notice
that appeared in the Federal Register on December 11, 2020. The
document announced the withdrawal of approval (as of January 11, 2021)
of 10 abbreviated new drug applications (ANDAs) from multiple
applicants. The document indicated that FDA was withdrawing approval of
the following two ANDAs after receiving a withdrawal request from
VistaPharm, Inc., 7265 Ulmerton Rd., Largo, FL 33771: ANDA 040323,
Prednisolone Syrup, 15 milligrams (mg)/5 milliliters (mL); and ANDA
075782, Valproic Acid Syrup, 250 mg/5 mL. Before FDA withdrew the
approval of these ANDAs, VistaPharm, Inc., informed FDA that it did not
want

the approval of the ANDAs withdrawn. Because VistaPharm, Inc., timely
requested that approval of these ANDAs not be withdrawn, the approval
of ANDAs 040323 and 075782 are still in effect.

FOR FURTHER INFORMATION CONTACT: Martha Nguyen, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 1676, Silver Spring, MD 20993-0002, 240-
402-6980<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of Friday, December
11, 2020 (85 FR 80119), appearing in FR Doc. 2020-27303, the following
correction is made:
    On page 80119, in the table, the entries for ANDAs 040323 and
075782 are removed.

    Dated: March 1, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05103 Filed 3-11-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 184 (Friday, September 21, 2012)]
[Notices]
[Page 58536]
[FR Doc No: 2012-23338]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:

Filings Instituting Proceedings

    Docket Numbers: RP12-985-000.
    Applicants: MarkWest Pioneer, L.L.C.
    Description: Quarterly Fuel Adjustment Filing of MarkWest Pioneer,
L.L.C.
    Filed Date: 8/31/12.
    Accession Number: 20120831-5054.
    Comments Due: 5 p.m. e.t. 9/26/12.

    Docket Numbers: RP12-1038-000.
    Applicants: ANR Pipeline Company.
    Description: Discount Type Adjustments to be effective 10/15/2012.
    Filed Date: 9/14/12.
    Accession Number: 20120914-5085.
    Comments Due: 5 p.m. e.t. 9/26/12.

    Docket Numbers: RP12-1039-000.
    Applicants: Alliance Pipeline L.P.
    Description: September 2012 Second Auction to be effective 9/14/
2012.
    Filed Date: 9/14/12.
    Accession Number: 20120914-5132.
    Comments Due: 5 p.m. e.t. 9/26/12.

    Docket Numbers: RP12-1040-000.
    Applicants: CenterPoint Energy Gas Transmission Comp.
    Description: CEGT LLC--Fuel Tracker Filing Effective November 1,
2012 to be effective 11/1/2012.
    Filed Date: 9/17/12.
    Accession Number: 20120917-5026.
    Comments Due: 5 p.m. e.t. 10/1/12.

    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.

Filings in Existing Proceedings

    Docket Numbers: CP10-16-002.
    Applicants: Cadeville Gas Storage LLC.
    Description: Certificate amendment to make changes to pro forma
tariff of Cadeville Gas Storage LLC.
    Filed Date: 8/17/12.
    Accession Number: 20120817-5013.
    Comments Due: 5 p.m. e.t. 9/24/12.

    Any person desiring to protest in any of the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5 p.m. Eastern time on the specified comment
date.
    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, and service 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 (202) 502-
8659.

    Dated: September 17, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-23338 Filed 9-20-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: August 28, 2008 (Volume 73, Number 168)]
[Rules and Regulations]
[Page 50716-50718]
[DOCID:fr28au08-7]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2008-0148; Directorate Identifier 2007-NM-299-AD;
Amendment 39-15655; AD 2008-17-17]
RIN 2120-AA64

Airworthiness Directives; Boeing Model 747 Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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

SUMMARY: We are adopting a new airworthiness directive (AD) for all
Boeing Model 747 airplanes. This AD requires a one-time inspection of
certain fuselage skins at section 41 to find any external doublers that
cover the inspection areas and to identify the external doublers that
end on a stringer and those that do not, and related investigative and
corrective actions if necessary. This AD results from reports of cracks
found at fastener locations in the fuselage skins at section 41. We are
issuing this AD to detect and correct fuselage skin cracks at fastener
locations along the skin-to-stringer attachments, which could join
together and become large and consequently result in rapid
decompression of the cabin.

DATES: This AD is effective October 2, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of October 2,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington 98124-
2207.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Ivan Li, Aerospace Engineer, Airframe
Branch, ANM-120S, FAA, Seattle Aircraft Certification Office, 1601 Lind
Avenue, SW., Renton, Washington 98057-3356; telephone<PHONE_NUMBER>;
fax<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
all Boeing Model 747 airplanes. That NPRM was published in the Federal
Register on February 8, 2008 (73 FR 7486). That NPRM proposed to
require a one-time inspection of certain fuselage skins at section 41
to find any external doublers that cover the inspection areas and to
identify the external doublers that end on a stringer and those that do
not, and related investigative and corrective actions if necessary.

Comments

    We gave the public the opportunity to participate in developing
this AD. We considered the comments received from the two commenters.

Support for the NPRM

    Boeing concurs with the contents of the NPRM.

Request to Either Delay Issuance of the AD or Extend the Compliance
Time

    Japan Airlines (JAL) requests that we delay issuance of the AD
until Boeing has published a revision to Boeing Alert Service Bulletin
747-53A2704, dated October 4, 2007, to extend the compliance time from
16,000 total flight cycles to 25,000 total flight cycles for
accomplishing the general visual inspection for external doublers in
Areas 2 and 3. If we cannot delay issuance of the AD, then JAL requests
that we revise the compliance time accordingly in this AD. JAL states
that Boeing has advised that only the inspection of Area 1 must be done
before 16,000 total flight cycles, and that Areas 2 and 3 should be
inspected together with the high frequency eddy current inspection of
the skin-to-stringer attachments before 25,000 total flight cycles. JAL
asserts that Boeing will revise the compliance time in the next
revision to the service bulletin.
    We do not agree to delay issuance of this AD, or to revise the
compliance time for inspecting for external doublers in Areas 2 and 3.
We have coordinated with Boeing, and Boeing has no plans, at this time,
to revise the service bulletin. Boeing also has confirmed that the
inspection of Areas 1, 2, and 3 was left at 16,000 total flight cycles
for simplicity of the compliance table in the service bulletin.
Therefore, we agree that, for Groups 1 through 5 airplanes,

the general visual inspection for external doublers in Areas 2 and 3
may be done before 25,000 total flight cycles, or within 2,000 flight
cycles after the effective date of this AD, whichever occurs later.
However, due to the unique nature of JAL's request, it would be best to
address it using the alternative methods of compliance (AMOC) process,
rather than revising this AD. We will consider requests for adjustments
to the compliance time, under the provisions of paragraph (h) of this
AD, if data are submitted to substantiate that such an adjustment would
provide an acceptable level of safety. We have not changed the AD in
this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD as proposed.

Costs of Compliance

    We estimate that this AD affects 165 airplanes of U.S. registry. We
also estimate that it takes up to 64 work-hours per product to comply
with this AD. The average labor rate is $80 per work-hour. Based on
these figures, we estimate the cost of this AD to the U.S. operators to
be $844,800 or $5,120 per product.

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.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will 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 this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under 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.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
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]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-17-17 Boeing: Amendment 39-15655. Docket No. FAA-2008-0148;
Directorate Identifier 2007-NM-299-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective October 2,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to all Boeing Model 747-100, 747-100B, 747-
100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D,
747-400F, 747SR, and 747SP series airplanes, certificated in any
category.

Unsafe Condition

    (d) This AD results from reports of cracks found at fastener
locations in the fuselage skins at section 41. We are issuing this
AD to detect and correct fuselage skin cracks at fastener locations
along the skin-to-stringer attachments, which could join together
and become large and consequently result in rapid decompression of
the cabin.

Compliance

    (e) Comply with this AD within the compliance times specified,
unless already done.

Repetitive Inspections and Related Investigative/Corrective Actions

    (f) At the applicable compliance times specified in Tables 1 and
2 of paragraph 1.E. of Boeing Alert Service Bulletin 747-53A2704,
dated October 4, 2007: Do a general visual inspection of the
fuselage skins at section 41 to find any external doublers that
cover the inspection area and to identify the external doublers that
end on a stringer in the inspection area and those that do not, and
do all the related investigative and corrective actions as
applicable, by accomplishing all of the applicable actions specified
in the Accomplishment Instructions of the service bulletin, except
as provided by paragraph (g) of this AD. Repeat the related
investigative actions thereafter at the interval specified in Tables
1 and 2 of the service bulletin, as applicable.

Exceptions to the Service Bulletin

    (g) Where Tables 1 and 2 of paragraph 1.E. of Boeing Alert
Service Bulletin 747-53A2704, dated October 4, 2007, specify
counting the compliance time from `` * * * after the date on this
service bulletin,'' this AD requires counting the compliance time
from the effective date of this AD. Where Figure 19 of the service
bulletin specifies doing a ``detailed visual inspection'' for any
crack at fastener holes common to the stringer, this AD requires
doing a detailed inspection. In Figure 3 of the service bulletin,
also inspect the areas at stringer 5 (S-5) and S-5A between station
(STA) 340 and STA 360 (similar to Figure 8 for the right side). In
Figure 15 of the service bulletin, also inspect the area at S-14A
between STA 200 and STA 220 (similar to Figure 17 for the right
side).

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, ATTN: Ivan Li, Aerospace Engineer, Airframe Branch, ANM-120S,
1601 Lind Avenue, SW., Renton, Washington 98057-3356; telephone
(425) 917-6437; fax<PHONE_NUMBER>; has the authority to approve
AMOCs for this AD, if requested using the procedures found in 14 CFR
39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair required by this AD, if it is approved by an
Authorized Representative for the Boeing Commercial Airplanes
Delegation Option Authorization Organization who has been authorized
by the Manager, Seattle ACO, to make those findings. For a repair
method to be approved, the repair must meet the certification basis
of the airplane, and the approval must specifically refer to this
AD.

Material Incorporated by Reference

    (i) You must use Boeing Alert Service Bulletin 747-53A2704,
dated October 4,

2007, to do the actions required by this AD, unless the AD specifies
otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, P.O. Box 3707, Seattle, Washington
98124-2207.
    (3) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_
regulations/ibr_locations.html.

    Issued in Renton, Washington, on August 8, 2008.
Ali Bahrami,
Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E8-19378 Filed 8-27-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 50 (Tuesday, March 15, 2011)]
[Notices]
[Page 14028]
[FR Doc No: 2011-5917]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2010-N-0381]

Generic Drug User Fee; Notice of Public Meeting; Reopening of the
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA) is reopening until June
30, 2011, the comment period for the notice of public meeting,
published in the Federal Register of August 9, 2010 (75 FR 47820),
entitled ``Generic Drug User Fee; Public Meeting; Request for
Comments.'' In that notice, FDA announced a public meeting that took
place on September 17, 2010, to gather stakeholder input on the
development of a generic drug user fee program. FDA is reopening the
comment period for the expected duration of the active negotiation
phase to ensure that all interested stakeholders have the opportunity
to share their views on the matter.

DATES: Submit either electronic or written comments by June 30, 2011.

ADDRESSES: Submit electronic comments 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: Peter C. Beckerman, Office of Policy,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 32, rm.
4238, Silver Spring, MD 20993,<PHONE_NUMBER>, FAX:<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In the Federal Register of August 9, 2010 (75 FR 47820), FDA
published a notice of a public meeting on the development of a generic
drug user fee (GDUF) program. In that notice, FDA posed several
questions related to a user fee for human generic drugs and sought
public input on such a program. The Agency received submissions and
presentations from the public meeting, which are now posted on FDA's
Web site. On November 4, 2010 (75 FR 67984), FDA subsequently reopened
the comment period for 30 days to allow consideration of submissions
received after the original docket closing date. Because after that
reopening FDA received multiple requests to reopen the docket,
including requests from generic industry segments that did not
previously comment, FDA reopened the docket again to permit public
input on all the submissions.
    Interested persons were originally given until October 17, 2010, to
comment on the development of a generic drug user fee program. In the
last docket reopening on January 24, 2011 (76 FR 4119), FDA reopened
the docket to permit comments until February 23, 2011.
    To ensure that all interested persons, whether a member of a trade
organization at the negotiating table or not, have sufficient
opportunity to share their views on the GDUF program throughout the
negotiation phase, FDA is reopening the comment period until June 30,
2011. FDA expects that the public component of the GDUF negotiations
will be complete by the end of June 2011. Therefore, the Agency is
reopening the comment period for this anticipated duration.

II. Additional Information on GDUF

    There is information on FDA's Web site that may be useful for
interested stakeholders to better understand FDA's effort to establish
a generic drug user fee and its current status. Information on the
September 17, 2010, public meeting on GDUF, the Federal Register notice
announcing the meeting, the transcript of the meeting, and slide
presentations from the meeting are available at http://www.fda.gov/Drugs/NewsEvents/ucm224121.htm. Additional information on that Web page
includes subsequent FDA updates, slide presentations, and speeches
related to generic drug user fees, and this is also where FDA will post
meeting minutes from the negotiation sessions with industry.

III. How To Submit 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. 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.

    Dated: March 9, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5917 Filed 3-14-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: January 13, 2010 (Volume 75, Number 8)]
[Rules and Regulations]
[Page 1705]
[DOCID:fr13ja10-6]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2009-1093]

Drawbridge Operation Regulation; Intracoastal Waterway (ICW),
Inside Thorofare, Ventnor City, NJ

AGENCY: Coast Guard, DHS.

ACTION: Notice of temporary deviation from regulations.

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

SUMMARY: The Commander, Fifth Coast Guard District, has issued a
temporary deviation from the regulations governing the operation of the
Dorset Avenue Bridge, at ICW mile 71.2, across Inside Thorofare, at
Ventnor City. This bridge is a double-leaf bascule drawbridge. The
deviation restricts the operation of the draw span to facilitate
structural rehabilitation to one of the bascule leafs.

DATES: This deviation is effective from 7 a.m. on January 20, 2010
until 11 p.m. on April 17, 2010.

ADDRESSES: Documents mentioned in this preamble as being available in
the docket are part of docket USCG-2009-1093 and are available online
by going to http://www.regulations.gov, inserting USCG-2009-1093 in the
``Keyword'' box and then clicking ``Search''. They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or e-mail Mrs. Sandra Elliott, Bridge Management Specialist, Fifth
District; Coast Guard; telephone<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>If you have questions on viewing the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION: The Dorset Avenue Bridge has a vertical
clearance in the closed position of 9 feet at mean high water and 12
feet at mean low water.
    A.P. Construction, Inc., on behalf of Atlantic County who owns and
operates this double-leaf bascule drawbridge, has requested a temporary
deviation from the current operating regulations set out in 33 CFR
117.733(g), to facilitate deck repairs.
    Under this temporary deviation, the drawbridge will provide a
partial opening of the lift spans for vessels. The deck repairs require
immobilizing half of the draw span to single-leaf operation beginning
at 7 a.m. on Wednesday, January 20, 2010, until and including 11 p.m.
on Saturday, April 17, 2010.
    Consequently, passage under the bridge will be limited to a 25-foot
width for the duration of the project.
    The single-bascule leaf not under repair will continue to open for
vessels. Prior to an opening of this single-bascule leaf, a work barge
occupying the channel underneath this span will also be moved. Finally,
the drawbridge will open in the event of an emergency.
    Bridge opening data, supplied by Atlantic County and reviewed by
the U.S. Coast Guard, revealed a small amount of vessel openings of the
draw span from January 2009 to April 2009. Specifically, the bridge
opened for vessels 4, 11, 11, and 19 times during the months of January
to April 2009, respectively. Vessels that can pass under the bridge
without a full bridge opening may continue to do so at all times.
Mariners requiring the full opening of the lift spans will be directed
to use the Atlantic Ocean as the alternate route.
    The Coast Guard will inform the users of the waterway through our
Local and Broadcast Notices to Mariners of the closure periods for the
bridge so that vessels can arrange their transits to minimize any
impact caused by the temporary deviation.
    In accordance with 33 CFR 117.35(e), the drawbridge must return to
its regular operating schedule immediately at the end of the designated
time period. This deviation from the operating regulations is
authorized under 33 CFR 117.35.

    Dated: December 18, 2009.
Waverly W. Gregory, Jr.,
Chief, Bridge Administration Branch, By direction of the Commander,
Fifth Coast Guard District.
[FR Doc. 2010-434 Filed 1-12-10; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: July 21, 2009 (Volume 74, Number 138)]
[Notices]
[Page 35882]
[DOCID:fr21jy09-72]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2009-0652]

Baton Rouge Waterways Action Plan Annex

AGENCY: Coast Guard, DHS.

ACTION: Notice of public meeting; request for comments.

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

SUMMARY: The Coast Guard announces a public meeting to receive comments
on the Baton Rouge Waterways Action Plan Annex.

DATES: A public meeting will be held on Thursday, July 30, 2009 from 8
a.m. to 11:30 a.m. and 1 p.m. to 4 p.m., and Friday, July 31, 2009 from
8 a.m. to 11:30 a.m. to provide an opportunity for oral comments.
Written comments and related material may also be submitted to Coast
Guard personnel specified at that meeting. All written comments and
related material submitted after the meeting must be received by the
Coast Guard on or before August 31, 2009.

ADDRESSES: The public meeting will be held in the Louisiana Room at the
State of Louisiana Department of Wildlife and Fisheries Building, 2000
Quail Drive, Baton Rouge, LA 70808, telephone<PHONE_NUMBER>. A
government-issued photo identification card will be required for
entrance to the building.
    You may submit written comments identified by docket number USCG-
2009-0652 before or after the meeting using any one of the following
methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand Delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
Our online docket for this meeting is available on the Internet at
http://www.regulations.gov under docket number USCG-2009-0652.

FOR FURTHER INFORMATION CONTACT: If you have questions concerning the
meeting, please call or e-mail Lieutenant Nick Parham, Chief of
Prevention and Response at Coast Guard Marine Safety Unit Baton Rouge;
telephone<PHONE_NUMBER>; e-mail<EMAIL_ADDRESS>If you have
questions on viewing or submitting material to the docket, call Renee
V. Wright, Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Background and Purpose

    The meeting is intended to give the public the chance to comment on
the current Baton Rouge Waterways Action Plan Annex and note concerns
and improvements that could be made to create a more consistent and
useful action plan. You may view the Baton Rouge Waterways Action Plan
Annex at the following Web site: http://www.uscg.mil/d8/westernrivers/
default.asp.
    You may view the online docket and comments submitted thus far by
going to http://www.regulations.gov. Once there, select the Advanced
Docket Search option on the right side of the screen, insert USCG-2009-
0652 in the Docket ID box, press Enter, and then click on the item in
the Docket ID column. You may also visit the Docket Management Facility
in Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. We have an agreement with the Department of Transportation to
use the Docket Management Facility.
    We encourage you to participate in this meeting by submitting
comments either orally at the meeting or in writing. If you bring
written comments to the meeting, you may submit them to Coast Guard
personnel specified at the meeting to receive written comments. These
comments will be submitted to our online public docket. All comments
received will be posted without change to http://www.regulations.gov
and will include any personal information you have provided.
    Comments submitted after the meeting must reach the Coast Guard on
or before August 31, 2009. If you submit a comment online via http://
www.regulations.gov, it will be considered received by the Coast Guard
when you successfully transmit the comment. If you fax, hand delivery,
or mail your comment, it will be considered as having been received by
the Coast Guard when it is received at the Docket Management Facility.
    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Information on Service for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the public meeting,
contact LT Nick Parham, United States Coast Guard, at the telephone
number or e-mail address indicated under the FOR FURTHER INFORMATION
CONTACT section of this notice.

Public Meeting

    The Coast Guard will hold a public meeting regarding the Baton
Rouge Waterways Action Plan Annex on Thursday, July 30, 2009 from 8
a.m. to 11:30 a.m. and 1 p.m. to 4 p.m., and Friday, July 31, 2009 from
8 a.m. to 11:30 a.m. at the Louisiana Room at the State of Louisiana
Department of Wildlife and Fisheries Building, 2000 Quail Drive, Baton
Rouge, LA 70808, telephone<PHONE_NUMBER>. The meeting location is not
accessible by public transportation. Parking is available at no cost.
    A government-issued photo identification card will be required for
entrance to the building. Attendees should check in at the front desk,
and they will be directed to the Louisiana Room.
    We will provide a written summary of the meeting and comments and
place that summary in the docket.

    Dated: July 9, 2009.
E.M. Stanton,
Captain, U.S. Coast Guard, Captain of the Port, New Orleans.
[FR Doc. E9-17246 Filed 7-20-09; 8:45 am]

BILLING CODE 4910-15-P


[Federal Register Volume 85, Number 169 (Monday, August 31, 2020)]
[Notices]
[Page 53832]
[FR Doc No: 2020-19133]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4557-DR; Docket ID FEMA-2020-0001]

Iowa; Amendment No. 1 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, Homeland Security (DHS).

ACTION: Notice.

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

SUMMARY: This notice amends the notice of a major disaster declaration
for the State of Iowa (FEMA-4557-DR), dated August 17, 2020, and
related determinations.

DATES: This amendment was issued August 20, 2020.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The notice of a major disaster declaration
for the State of Iowa is hereby amended to include Individual
Assistance for the following area among those areas determined to have
been adversely affected by the event declared a major disaster by the
President in his declaration of August 17, 2020.
    Linn County for Individual Assistance (already designated for
Public Assistance).

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050 Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Pete Gaynor,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2020-19133 Filed 8-28-20; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register Volume 87, Number 239 (Wednesday, December 14, 2022)]
[Notices]
[Pages 76492-76493]
[FR Doc No: 2022-27022]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-N-2969]

Advisory Committee; Endocrinologic and Metabolic Drugs Advisory
Committee; Renewal

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; renewal of Federal advisory committee.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
renewal of the Endocrinologic and Metabolic Drugs Advisory Committee by
the Commissioner of Food and Drugs (the Commissioner). The Commissioner
has determined that it is in the public interest to renew the
Endocrinologic and Metabolic Drugs Advisory Committee for an additional
2 years beyond the charter expiration date. The new charter will be in
effect until the August 27, 2024, expiration date.

DATES: Authority for the Endocrinologic and Metabolic Drugs Advisory
Committee will expire on August 27, 2024, unless the Commissioner
formally determines that renewal is in the public interest.

FOR FURTHER INFORMATION CONTACT: LaToya Bonner, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002, 301-
796-2855, [email protected].

SUPPLEMENTARY INFORMATION: Pursuant to 41 CFR 102-3.65 and approval by
the Department of Health and Human Services and by the General Services
Administration, FDA is announcing the renewal of the Endocrinologic and
Metabolic Drugs Advisory Committee (the Committee). The Committee is a
discretionary Federal advisory committee established to provide advice
to the Commissioner. The Committee advises the Commissioner or designee
in discharging responsibilities as they relate to helping to ensure
safe and effective drugs for human use and, as required, any other
product for which FDA has regulatory responsibility.
    The Committee reviews and evaluates data concerning the safety and
effectiveness of marketed and investigational human drug products for
use in the treatment of endocrine and metabolic disorders and makes
appropriate recommendations to the Commissioner.
    The Committee shall consist of a core of 11 voting members
including the Chair. Members and the Chair are selected by the
Commissioner or designee from among authorities knowledgeable in the
fields of endocrinology, metabolism, epidemiology or statistics, and
related specialties. Members will be invited to serve for overlapping
terms of up to 4 years. Non-Federal members of this committee will
serve as Special Government Employees, representatives, or Ex-Officio
members. Federal members will serve as Regular Government Employees or
Ex-Officios. The core of voting members may include one technically
qualified member, selected by the Commissioner or designee, who is
identified with consumer interests and is recommended by either a
consortium of consumer-oriented organizations or other interested
persons. In addition to the voting members, the Committee may include
one non-voting representative member who is identified with industry

interests. There may also be an alternate industry representative.
    Further information regarding the most recent charter and other
information can be found at https://www.fda.gov/advisory-committees/endocrinologic-and-metabolic-drugs-advisory-committee/endocrinologic-and-metabolic-drugs-advisory-committee-charter or by contacting the
Designated Federal Officer (see FOR FURTHER INFORMATION CONTACT). In
light of the fact that no change has been made to the committee name or
description of duties, no amendment will be made to 21 CFR 14.100.
    This notice is issued under the Federal Advisory Committee Act (5
U.S.C. app.). For general information related to FDA advisory
committees, please visit us at https://www.fda.gov/AdvisoryCommittees/default.htm.

    Dated: December 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-27022 Filed 12-13-22; 8:45 am]
BILLING CODE 4164-01-P