[Federal Register Volume 88, Number 192 (Thursday, October 5, 2023)]
[Notices]
[Pages 69240-69241]
[FR Doc No: 2023-22192]

=======================================================================
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SECURITIES AND EXCHANGE COMMISSION

[Release No.: 34-98672]

Public Availability of the Securities and Exchange Commission's
Fiscal Year (FY) 2020 Service Contract Inventory

AGENCY: Securities and Exchange Commission.

ACTION: Notice.

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SUMMARY: In accordance with section 743 of division C of the
Consolidated Appropriations Act of 2010, the SEC is publishing this
notice to advise the public of the availability of the FY2020 Service
Contract Inventory (SCI) along with the FY2021 SCI Planned Analysis.

FOR FURTHER INFORMATION CONTACT: Direct questions regarding the service
contract inventory to Vance Cathell, Director Office of Acquisitions
202.551.8385 or [email protected].

SUPPLEMENTARY INFORMATION: The SCI provides information on FY2020
actions over $150,000 for service contracts. The inventory organizes
the information by function to show how SEC distributes contracted
resources throughout the

agency. The SEC developed the inventory per the guidance issued on
January 17, 2017, by the Office of Management and Budget's Office of
Federal Procurement Policy (OFPP). OFPP's guidance is available at
https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/memoranda/2017/service_contract_inventories.pdf.
    The Service Contract Inventory Analysis for FY2020 provides
information based on the FY 2020 Inventory. Please note that the SEC's
FY 2020 Service Contract Inventory data is now included in government-
wide inventory available on https://www.acquisition.gov. The
government-wide inventory can be filtered to display the inventory data
for the SEC. The SEC has posted the FY 2020 SCI Analysis and its FY
2021 plans for analyzing data on the SEC's homepage at https://www.sec.gov/about/secreports.shtml and https://www.sec.gov/open.

    Dated: October 2, 2023.
Vanessa A. Countryman,
Secretary.
[FR Doc. 2023-22192 Filed 10-4-23; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 79, Number 7 (Friday, January 10, 2014)]
[Proposed Rules]
[Pages 1772-1774]
[FR Doc No: 2014-00234]

========================================================================
Proposed Rules
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.

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

Federal Register / Vol. 79, No. 7 / Friday, January 10, 2014 /
Proposed Rules

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2013-1071; Directorate Identifier 2013-NM-204-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for all
The Boeing Company Model 777 airplanes. This proposed AD was prompted
by reports of latently failed fuel shutoff valves discovered during
fuel filter replacement. This proposed AD would require revising the
maintenance or inspection program to include a new airworthiness
limitation. We are proposing this AD to detect and correct latent
failures of the fuel shutoff valve to the engine, which could result in
the inability to shut off fuel to the engine and, in case of certain
engine fires, an uncontrollable fire that could lead to wing failure.

DATES: We must receive comments on this proposed AD by February 24,
2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2013-
1071; 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 proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Rebel Nichols, Aerospace Engineer,
Propulsion Branch, ANM-140S, FAA, Seattle Aircraft Certification
Office, 1601 Lind Avenue SW., Renton, WA 98057-3356; phone: (425) 917-
6509; fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2013-1071;
Directorate Identifier 2013-NM-204-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because 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 we
receive about this proposed AD.

Discussion

    We have received reports of latently failed fuel shutoff valves
discovered during fuel filter replacement. Deficiencies in the valve
actuator design have resulted in latent failures of the fuel shutoff
valve to the engine. This condition, if not detected and corrected,
could result in latent failures of the fuel shutoff valve to the
engine, which could result in the inability to shut off fuel to the
engine and, in case of certain engine fires, an uncontrollable fire
that could lead to wing failure.

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or develop in other products of the same type design.

Proposed AD Requirements

    This proposed AD would require revising the maintenance or
inspection program to include a new airworthiness limitation.
    This proposed AD would require revisions to certain operator
maintenance documents to include new inspections. Compliance with these
inspections is required by section 91.403(c) of the Federal Aviation
Regulations (14 CFR 91.403(c)). For airplanes that have been previously
modified, altered, or repaired in the areas addressed by these
inspections, an operator might not be able to accomplish the
inspections described in the revisions. In this situation, to comply
with 14 CFR 91.403(c), the operator must request approval of an
alternative method of compliance (AMOC) in accordance with the
provisions of paragraph (i) of this proposed AD. The request should
include a description of changes to the proposed inspections that will
ensure the continued operational safety of the airplane.

Interim Action

    We consider this proposed AD interim action. The manufacturer is
currently developing a modification that will address the unsafe
condition identified in this proposed AD. Once this modification is
developed, approved, and available, we might consider additional
rulemaking.

Costs of Compliance

    We estimate that this proposed AD affects 190 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per       Cost on U.S.
               Action                        Labor cost           Parts cost        product         operators
----------------------------------------------------------------------------------------------------------------
Incorporating Airworthiness           1 work-hour x $85 per                $0              $85          $16,150
 Limitation.                           hour = $85.
----------------------------------------------------------------------------------------------------------------

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

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. 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 this 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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2013-1071; Directorate Identifier
2013-NM-204-AD.

(a) Comments Due Date

    We must receive comments by February 24, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all The Boeing Company Model 777-200, -200LR,
-300, -300ER, and 777F series airplanes, certificated in any
category.

(d) Subject

    Joint Aircraft System Component (JASC) Code 2823, Fuel Selector/
Shut-off Valve.

(e) Unsafe Condition

    This AD was prompted by reports of latently failed fuel shutoff
valves discovered during fuel filter replacement. We are issuing
this AD to detect and correct latent failures of the fuel shutoff
valve to the engine, which could result in the inability to shut off
fuel to the engine and, in case of certain engine fires, an
uncontrollable fire that could lead to wing failure.

(f) Compliance

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

(g) Revision of Maintenance or Inspection Program

    Within 30 days after the effective date of this AD, revise the
maintenance or inspection program, as applicable, to add
airworthiness limitation number 28-AWL-MOV by incorporating the
information specified in Figure 1 to paragraph (g) of this AD into
the Airworthiness Limitations Section of the Instructions for
Continued Airworthiness. The initial compliance time for
accomplishing the actions specified in Figure 1 to paragraph (g) of
this AD is within 7 days after accomplishing the maintenance or
inspection program revision required by this paragraph.

      Figure 1 to Paragraph (g) of This AD: Engine Shut-Off Valve (Fuel Spar Valve) MOV Actuator Inspection
----------------------------------------------------------------------------------------------------------------
        AWL No.                  Task                 Interval            Applicability          Description
----------------------------------------------------------------------------------------------------------------
28-AWL-MOV............  ALI..................  WEEKLY...............  ALL.................  Engine Shut-Off
                                                                                Valve (Fuel Spar
                                                                                Valve) MOV Actuator
                                                                                Inspection.
                                                                                Concern: The MOV
                                                                                actuator design can
                                                                                result in airplanes
                                                                                operating with a
                                                                                failed MOV actuator
                                                                                that is not
                                                                                reported. A
                                                                                latently failed MOV
                                                                                actuator would
                                                                                prevent fuel
                                                                                shutoff to an
                                                                                engine. In the
                                                                                event of certain
                                                                                engine fires, the
                                                                                potential exists
                                                                                for an engine fire
                                                                                to be
                                                                                uncontrollable.
                                                                                Perform an
                                                                                inspection of the
                                                                                Fuel Spar Valve MOV
                                                                                Actuator position
                                                                                (refer to Boeing
                                                                                AMM 28-22-00).
                                                                                NOTE: The Fuel Spar
                                                                                Valve MOV Actuator
                                                                                is located behind
                                                                                latch panel 551 DB
                                                                                (left engine) and
                                                                                latch panel 651 DB
                                                                                (right engine).

                                                                                1. Make sure both
                                                                                Engine Control
                                                                                Switches are in the
                                                                                CUTOFF position.
                                                                                2. Inspect the left
                                                                                engine fuel spar
                                                                                valve actuator
                                                                                located in the left
                                                                                rear spar.
                                                                                a. Verify the manual
                                                                                override handle on
                                                                                the engine fuel
                                                                                spar valve actuator
                                                                                is in the CLOSED
                                                                                position.
                                                                                b. Repair or replace
                                                                                any MOV actuator
                                                                                that is not in the
                                                                                CLOSED position
                                                                                (refer to Boeing
                                                                                Airplane
                                                                                Maintenance Manual,
                                                                                28-22-02).
                                                                                3. Inspect the right
                                                                                engine fuel spar
                                                                                valve actuator
                                                                                located in the
                                                                                right rear spar.
                                                                                a. Verify the manual
                                                                                override handle on
                                                                                the engine fuel
                                                                                spar valve actuator
                                                                                is in the CLOSED
                                                                                position.
                                                                                b. Repair or replace
                                                                                any MOV actuator
                                                                                that is not in the
                                                                                CLOSED position
                                                                                (refer to Boeing
                                                                                Airplane
                                                                                Maintenance Manual,
                                                                                28-22-02).
----------------------------------------------------------------------------------------------------------------

(h) No Alternative Actions and Intervals

    After accomplishment of the maintenance or inspection program
revision required by paragraph (g) of this AD, no alternative
actions (e.g., inspections) or intervals may be used unless the
actions or intervals are approved as an alternative method of
compliance (AMOC) in accordance with the procedures specified in
paragraph (i)(1) of this AD.

(i) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO)
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (j) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.

(j) Related Information

    For more information about this AD, contact Rebel Nichols,
Aerospace Engineer, Propulsion Branch, ANM-140S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA
98057-3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
    Issued in Renton, Washington, on December 30, 2013.
John P. Piccola,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-00234 Filed 1-9-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 225 (Wednesday, November 23, 2022)]
[Notices]
[Pages 71654-71655]
[FR Doc No: 2022-25622]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-2922]

Compounding Certain Beta-Lactam Products in Shortage Under
Section 503A of the Federal Food, Drug, and Cosmetic Act; Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a final guidance for industry entitled
``Compounding Certain Beta-Lactam Products in Shortage Under Section
503A of the Federal Food, Drug, and Cosmetic Act.'' This guidance
describes FDA's regulatory and enforcement priorities regarding
preparation of beta-lactam oral antibiotic suspension products that
appear on FDA's drug shortage list by a licensed pharmacist in a State-
licensed pharmacy or Federal facility.

DATES: The announcement of the guidance is published in the Federal
Register on November 23, 2022.

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

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2022-D-2922 for ``Compounding Certain Beta-Lactam Products in
Shortage Under Section 503A of the Federal Food, Drug, and Cosmetic
Act.'' Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions,'' publicly viewable at
https://www.regulations.gov or at the Dockets Management Staff between
9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available

for public viewing and posted on https://www.regulations.gov. Submit
both copies to the Dockets Management Staff. If you do not wish your
name and contact information to be made publicly available, you can
provide this information on the cover sheet and not in the body of your
comments and you must identify this information as ``confidential.''
Any information marked as ``confidential'' will not be disclosed except
in accordance with 21 CFR 10.20 and other applicable disclosure law.
For more information about FDA's posting of comments to public dockets,
see 80 FR 56469, September 18, 2015, or access the information at:
https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002. Send one self-
addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Tracy Rupp, Office of Compounding
Quality and Compliance, Center for Drug Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD
20993,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Compounding Certain Beta-Lactam Products in Shortage Under
Section 503A of the Federal Food, Drug, and Cosmetic Act.'' This
guidance is being implemented without prior public comment because FDA
has determined that prior public participation for this guidance is not
feasible or appropriate (see section 701(h)(1)(C) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 371(h)(1)(C)) and 21 CFR
10.115(g)(2)). This guidance document is being implemented immediately
because of the public health need for amoxicillin oral antibiotic
suspension products, but it remains subject to comment in accordance
with the Agency's good guidance practices.
    This guidance describes the Agency's regulatory and enforcement
priorities regarding preparation of beta-lactam oral antibiotic
suspension products that appear on FDA's drug shortage list by a
licensed pharmacist in a State-licensed pharmacy or Federal facility.
FDA has received a number of reports related to increased demand for
amoxicillin oral antibiotic suspension products in particular.
Amoxicillin oral antibiotic powder for suspension products currently
appear on FDA's drug shortage list. FDA has also received requests for
clarification about preparation of compounded versions of those
products from FDA-approved tablets and capsules.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Compounding Certain Beta-Lactam Products
in Shortage Under Section 503A of the FD&C Act.'' It does not establish
any rights for any person and is not binding on FDA or the public. You
can use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This guidance contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 (44 U.S.C. 3501-3521) is not required.

III. Electronic Access

    Persons with access to the internet may obtain the document at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: November 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-25622 Filed 11-22-22; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: April 22, 2008 (Volume 73, Number 78)]
[Notices]
[Page 21684-21685]
[DOCID:fr22ap08-94]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

 Notice Before Waiver With Respect to Land at Lonesome Pine
Airport, Wise, VA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of intent of waiver with respect to land.

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

SUMMARY: The FAA is publishing notice of proposed release of
approximately 27.07 acres of land at the Lonesome Pine Airport, Wise,
Virginia to Wise County (Portions of Property Map Parcels 4, 5, 6). The
release of land will provide a location for a regional business &
technology park and an emergency services training facility. Releasing
the land does not adversely impact the Airport and the land is not
needed for airport development as shown on the Airport Layout Plan.
Fair Market Value of the land has been assessed and will be provided to
The Cumberlands Airport Commission for Airport and Commission
development expenses.

DATES: Comments must be received on or before May 22, 2008.

ADDRESSES: Comments on this application may be mailed or delivered in
triplicate to the FAA at the following address: Terry J. Page, Manager,
FAA Washington Airports District Office, 23723 Air Freight Lane, Suite
210, Dulles, VA 20166.
    In addition, one copy of any comments submitted to the FAA must be
mailed or delivered to Donnie Rose, Cumberlands Airport Commission, at
the following address: Donnie Rose, Chairman, Cumberlands Airport
Commission, PO Box 1752, Wise, Virginia 24293.

FOR FURTHER INFORMATION CONTACT: Mr. Terry Page, Manager, Washington
Airports District Office, 23723 Air Freight Lane, Suite 210, Dulles, VA
20166; telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, e-mail
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: On April 5, 2000, new authorizing
legislation became effective. That bill, the Wendell H. Ford Aviation
investment and Reform Act for the 21st Century, Public Law 10-181 (Apr.
5, 2000; 114 Stat. 61) (AIR 21) requires that a 30-day public notice
must be provided before the Secretary may waive any condition imposed
on an interest in surplus property.

    Issued in Chantilly, Virginia on April 4, 2008.
Terry J. Page,
Manager, Washington Airports District Office, Eastern Region.
 [FR Doc. E8-8580 Filed 4-21-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register Volume 78, Number 86 (Friday, May 3, 2013)]
[Notices]
[Page 26106]
[FR Doc No: 2013-10528]

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DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No FMCSA-2011-0097]

Pilot Program on NAFTA Trucking Provisions

AGENCY: Federal Motor Carrier Safety Administration (FMCSA).

ACTION: Notice; correction.

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

SUMMARY: The FMCSA published a document in the Federal Register of
April 24, 2013 concerning request for public comment on data and
information concerning the Pre-Authorization Safety Audit (PASA) for
RAM Trucking SA de CV (RAM) with U.S. Department of Transportation
(USDOT) number 2063285. The notice is missing a date in Table 2, line
one, column H.

FOR FURTHER INFORMATION CONTACT: Marcelo Perez, Telephone: (512) 916-
5440 Ext. 228 or email<EMAIL_ADDRESS>
Correction

    In the Federal Register, Volume 78, No. 79 of Wednesday, April 24,
2013, in the FR Doc. 2013-09691, on page 24295 in Table 2, correct
Table 2, line one, column H, which is empty, to read:

                                          Table 2--Successful Pre-Authorization Safety Audit (PASA) Information
                                                                [See also Tables 3 and 4]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                     Column D--    Column E--    Column F--                      Column H--
  Column A--row    Column B--name of  Column C--US      FMCSA         PASA          PASA       Column G--PASA       FMCSA     Column I--US  Column J--US
       No.              carrier          DOT No.    register No.    initiated     completed        results        register       drivers      vehicles
--------------------------------------------------------------------------------------------------------------------------------------------------------
1...............  RAM Trucking SA de      2063285     MX-721816    07/23/2012    08/08/2012   Pass............    4/22/2013             1             1
                   CV.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    Issued on: April 26, 2013.
 Larry W. Minor,
Associate Administrator, Policy.
[FR Doc. 2013-10528 Filed 5-2-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 79, Number 125 (Monday, June 30, 2014)]
[Proposed Rules]
[Pages 36678-36680]
[FR Doc No: 2014-15250]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0426; Directorate Identifier 2013-NM-231-AD]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for
certain The Boeing Company Model 767 and 777 airplanes. This proposed
AD was prompted by reports of uncommanded door closure of the large
lower lobe cargo door. This proposed AD would require inspecting for
part numbers and serial numbers of the rotary actuators of the large
forward and aft lower lobe cargo doors, as applicable, and corrective
action if necessary. We are proposing this AD to detect and correct
rotary actuators made with a material having poor actuator gear wear
characteristics, which could result in failure of the rotary actuators
for the large forward or aft lower lobe cargo door and subsequent
uncommanded door closure, which could possibly result in injury to
people on the ground.

DATES: We must receive comments on this proposed AD by August 14, 2014.

ADDRESSES: You may send comments, using the procedures found in 14 CFR
11.43 and 11.45, by any of the following methods:
     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: Deliver to Mail address above between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.
    For Boeing service information identified in this proposed AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207; telephone
206-544-5000, extension 1; fax<PHONE_NUMBER>; Internet https://www.myboeingfleet.com. For Eaton service information identified in this
proposed AD, contact Eaton Corporation, Aerospace Operations, 3 Park
Plaza, Suite 1200, Irvine, CA 92614; telephone<PHONE_NUMBER>; fax 949-
253-2111; Internet http://www.eaton.com. You may view this referenced
service information at the FAA, Transport Airplane Directorate, 1601
Lind Avenue SW., Renton, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2014-
0426; 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 proposed AD, the regulatory evaluation, any comments
received, and other information. The street address for the Docket
Office (phone:<PHONE_NUMBER>) is in the ADDRESSES section. Comments will
be available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Susan Monroe, Aerospace Engineer,
Cabin Safety and Environmental Systems Branch, ANM-150S, FAA, Seattle
Aircraft Certification Office, 1601 Lind Avenue SW., Renton, WA 98057-
3356; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; email:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposal. Send your comments to an address listed
under the ADDRESSES section. Include ``Docket No. FAA-2014-0426;
Directorate Identifier 2013-NM-231-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because 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 we
receive about this proposed AD.

Discussion

    We received reports of uncommanded door closure of the large lower
lobe cargo door. One incident occurred while the door was being opened,
a second one while the door was stationary in the open position, and
the third incident occurred as the door was being closed. It was
determined that all of the doors' rotary actuators had failed (two
actuators per door). The three incidents occurred on Model 767
airplanes, but the same rotary actuator part numbers are also used on
the large lower lobe cargo doors installed on the Model 777 airplanes.
Examination of five of the failed rotary actuators found significant
wear in the gear box and failure of the first stage input sun gear set.
The sixth failed rotary actuator had a failed third-stage input sun
gear from an overload condition. All three affected airplanes had
between 12,500 and 13,500 total flight cycles. The failed actuators
were manufactured with Nitralloy 135M steel between August 1994 and
December 2000. Actuators manufactured before or after that timeframe
were made with 9310 steel. The rotary actuators made from 9310 steel
material are considered safe. This condition, if not corrected, could
result in failure of the rotary actuators for the large lower lobe
cargo door, and subsequent uncommanded door closures, which could
possibly result in injury to people on the ground.

Relevant Service Information

    We reviewed Boeing Service Bulletins 767-52A0100, Revision 2, dated
September 26, 2013; and 777-52-0053, Revision 1, dated September 26,
2013. For information on the procedures and compliance times, see this
service information at http://www.regulations.gov by searching for and
locating Docket No. FAA-2014-0426.
    Boeing Service Bulletins 767-52A0100, Revision 2, dated September
26, 2013; and 777-52-0053, Revision 1, dated September 26, 2013; refer
to Eaton Service Bulletin 692D100-52-4, Revision 2, dated August 1,
2013, which provides serial number information and certain corrective
actions (rework of certain rotary actuators or reidentification of
certain other rotary actuators).

FAA's Determination

    We are proposing this AD because we evaluated all the relevant
information and determined the unsafe condition described previously is
likely to exist or

develop in other products of these same type designs.

Proposed AD Requirements

    This proposed AD would require inspecting for part numbers and
serial numbers of the rotary actuators of the large forward and aft
lower lobe cargo doors, as applicable, and corrective actions if
necessary, as specified in the service information described
previously.
    The phrase ``corrective actions'' is used in this proposed AD.
``Corrective actions'' are actions that correct or address any
condition found. Corrective actions in an AD could include, for
example, repairs.

Costs of Compliance

    We estimate that this proposed AD affects 510 airplanes of U.S.
registry.
    We estimate the following costs to comply with this proposed AD:

                                                 Estimated Costs
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
               Action                      Labor cost            Parts cost           product        operators
----------------------------------------------------------------------------------------------------------------
Inspection for part number and       1 work-hour x $85 per  None................            $85        $43,350.
 serial number.                       hour = $85.
----------------------------------------------------------------------------------------------------------------

    We estimate the following costs to do any necessary re-
identification or replacements that would be required based on the
results of the proposed inspection. We have no way of determining the
number of aircraft that might need these re-identifications or
replacements:

                                               On-Condition Costs
----------------------------------------------------------------------------------------------------------------
                Action                         Labor cost          Parts cost           Cost per product
----------------------------------------------------------------------------------------------------------------
Re-identification.....................  Up to 1 work-hour x $85            $1  Up to $86.
                                         per hour = $85.
Replacement...........................  Up to 9 work-hours x $85       19,700  Up to $20,465.
                                         per hour = $765.
----------------------------------------------------------------------------------------------------------------

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 proposed 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

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. 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 this 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),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) 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.

List of Subjects in 14 CFR Part 39

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

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 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 airworthiness
directive (AD):

The Boeing Company: Docket No. FAA-2014-0426; Directorate Identifier
2013-NM-231-AD.

(a) Comments Due Date

    We must receive comments by August 14, 2014.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company airplanes identified in
paragraphs (c)(1) and (c)(2) of this AD, certificated in any
category.
    (1) Model 767-200, -300, -300F, and -400ER series airplanes, as
identified in Boeing Service Bulletin 767-52A0100, Revision 2, dated
September 26, 2013.
    (2) Model 777-200, -200LR, -300, -300ER, and 777F series
airplanes, as identified in Boeing Service Bulletin 777-52-0053,
Revision 1, dated September 26, 2013.

(d) Subject

    Air Transport Association (ATA) of America Code 52, Doors.

(e) Unsafe Condition

    This AD was prompted by reports of uncommanded door closure of
the large lower lobe cargo door. We are issuing this AD to detect
and correct rotary actuators made with a material having poor wear
characteristics, which could result in failure of the rotary
actuators for the large forward or aft lower lobe cargo door and
subsequent uncommanded door closure, which could possibly result in
injury to people on the ground.

(f) Compliance

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

(g) Inspection for Part Numbers, and Re-Identification or Replacement,
for Model 767 Airplanes

    For Model 767-200, -300, -300F, and -400ER series airplanes:
Within 30 months after the effective date of this AD, inspect each
rotary actuator installed in the forward

and aft large lower lobe cargo doors, as applicable, to determine
the part number and serial number, and do all applicable corrective
actions, in accordance with the Accomplishment Instructions of
Boeing Service Bulletin 767-52A0100, Revision 2, dated September 26,
2013; and Eaton Service Bulletin 692D100-52-4, Revision 2, dated
August 1, 2013. Do the applicable corrective actions at the
applicable time specified in paragraph 1.E., ``Compliance,'' of
Boeing Service Bulletin 767-52A0100, Revision 2, dated September 26,
2013, except as required by paragraph (i) of this AD. A review of
maintenance records for the part number and serial number is
acceptable in lieu of the inspection if the part and serial numbers
of the rotary actuator can be conclusively determined from that
review.

(h) Inspection for Part Numbers, and Re-Identification or Replacement,
for Model 777 Airplanes

    For Model 777-200, -200LR, -300, -300ER, and 777F series
airplanes: Within 72 months after the effective date of this AD,
inspect each rotary actuator installed in the forward and aft large
lower lobe cargo doors, as applicable, to determine the part number
and serial number, and do all applicable corrective actions, in
accordance with the Accomplishment Instructions of Boeing Service
Bulletin 777-52-0053, Revision 1, dated September 26, 2013; and
Eaton Service Bulletin 692D100-52-4, Revision 2, dated August 1,
2013. Do the applicable corrective actions at the applicable time
specified in paragraph 1.E., ``Compliance,'' of Boeing Service
Bulletin 777-52-0053, Revision 1, dated September 26, 2013, except
as required by paragraph (i) of this AD. A review of maintenance
records for the part number and serial number is acceptable in lieu
of the inspection if the part and serial numbers of the rotary
actuator can be conclusively determined from that review.

(i) Exception to the Service Information

    Where Boeing Service Bulletin 767-52A0100, Revision 2, dated
September 26, 2013; and Boeing Service Bulletin 777-52-0053,
Revision 1, dated September 26, 2013, specify a compliance time
after the issue date ``of this service bulletin,'' this AD requires
compliance within the specified compliance time after the effective
date of this AD.

(j) Parts Installation Prohibition

    As of the effective date of this AD, no rotary actuator having
Boeing part number S135W132-3 (supplier part number 692D100-13) may
be installed on any airplane.

(k) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle Aircraft Certification Office (ACO),
FAA, has the authority to approve AMOCs for this AD, if requested
using the procedures found in 14 CFR 39.19. In accordance with 14
CFR 39.19, send your request to your principal inspector or local
Flight Standards District Office, as appropriate. If sending
information directly to the manager of the ACO, send it to the
attention of the person identified in paragraph (l)(1) of this AD.
Information may be emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (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 the
Boeing Commercial Airplanes Organization Designation Authorization
(ODA) that 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.

(l) Related Information

    (1) For more information about this AD, contact Susan Monroe,
Aerospace Engineer, Cabin Safety and Environmental Systems Branch,
ANM-150S, FAA, Seattle Aircraft Certification Office, 1601 Lind
Avenue SW., Renton, WA 98057-3356; phone:<PHONE_NUMBER>; fax: 425-
917-6590; email<EMAIL_ADDRESS>    (2) For Boeing service information identified in this AD,
contact Boeing Commercial Airplanes, Attention: Data & Services
Management, P.O. Box 3707, MC 2H-65, Seattle, WA 98124-2207;
telephone<PHONE_NUMBER>, extension 1; fax<PHONE_NUMBER>; Internet
https://www.myboeingfleet.com. For Eaton service information
identified in this AD, contact Eaton Corporation, Aerospace
Operations, 3 Park Plaza, Suite 1200, Irvine, CA 92614; telephone
949-253-2100; fax<PHONE_NUMBER>; Internet http://www.eaton.com. You
may view this referenced service information at the FAA, Transport
Airplane Directorate, 1601 Lind Avenue SW., Renton, Washington. For
information on the availability of this material at the FAA, call
425-227-1221.

    Issued in Renton, Washington, on June 19, 2014.
Michael Kaszycki,
Acting Manager, Transport Airplane Directorate, Aircraft Certification
Service.
[FR Doc. 2014-15250 Filed 6-27-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 163 (Friday, August 21, 2020)]
[Rules and Regulations]
[Pages 51635-51639]
[FR Doc No: 2020-17085]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 610

[Docket No. FDA-2018-N-4757]
RIN 0910-AH95

Revocation of the Test for Mycoplasma

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to remove the specified test for the presence of
Mycoplasma for live virus vaccines and inactivated virus vaccines
produced from in vitro living cell cultures. The rule is being
finalized because the existing test for Mycoplasma is overly
restrictive in that it identifies only one test method in detail to be
used even though other methods also may be appropriate. More sensitive
and specific methods exist and are currently being practiced, and
removal of the specific method to test for Mycoplasma provides
flexibility for accommodating new and evolving technology and
capabilities without diminishing public health protections. This action
is part of FDA's implementation of Executive Orders under which FDA is
comprehensively reviewing existing regulations to identify
opportunities for repeal, replacement, or modification that will result
in meaningful burden reduction, while allowing the Agency to achieve
our public health mission and fulfill statutory obligations.

DATES: This rule is effective September 21, 2020.

ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
docket number found in brackets in the heading of this final rule into
the ``Search'' box and follow the prompts, and/or go to the Dockets
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-
402-7911.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Introduction
    B. Need for the Regulation
    C. Summary of Comments to the Proposed Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Comments and FDA Response
V. Effective Date
VI. Economic Analysis of Impacts
    A. Introduction
    B. Summary of Costs and Benefits
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References

I. Executive Summary

A. Purpose of the Final Rule

    FDA is removing the regulation requiring a specified test for the
presence of Mycoplasma for live virus vaccines produced from in vitro
living cell cultures and inactivated virus vaccines produced from such
living cell cultures because the regulation is overly restrictive in
that it identifies only one test method in detail to be used even
though other methods also may be appropriate. More sensitive and
specific methods exist and are currently being practiced, and removal
of the required test for Mycoplasma provides flexibility for
accommodating new and evolving technology and capabilities without
diminishing public health protections.

B. Summary of the Major Provisions of the Final Rule

    The final rule removes Sec.  610.30 (21 CFR 610.30), which details
the method for Mycoplasma testing of samples of the virus harvest pool
and control fluid pool of live virus vaccines and inactivated virus
vaccines produced from in vitro living cell cultures.

C. Legal Authority

    FDA is taking this action under the biological products provisions
of the Public Health Service Act (the PHS Act), and the drugs and
general administrative provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act).

D. Costs and Benefits

    Because this final rule will not impose any additional regulatory
burdens, this regulation is not anticipated to result in any compliance
costs and the economic impact is expected to be minimal.

II. Background

A. Introduction

    On February 24, 2017, Executive Order 13777, ``Enforcing the
Regulatory Reform Agenda'' (https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda; 82 FR
12285, March 1, 2017) was issued. One of the provisions in the
Executive Order requires Agencies to evaluate existing regulations and
make recommendations to the Agency head regarding their repeal,
replacement, or modification, consistent with applicable law. As part
of this initiative, FDA is revoking a regulation as specified in this
final rule.

B. Need for the Regulation

    It has become increasingly clear that the requirement specifying a
test for Mycoplasma is too restrictive for live virus vaccines and
inactivated virus vaccines produced from in vitro living cell cultures
because they specify particular methodologies when alternatives may be
available that provide the same or greater level of assurance of
safety. Modifications to Mycoplasma testing described in Sec.  610.30
must meet the requirements of 21 CFR 610.9.
    Thus, the Agency believes that the regulation may no longer reflect
the current testing procedures as a general matter and that it is more
appropriate, flexible, and efficient to identify appropriate testing
requirements for particular products in the biologics license
application (BLA).
    This final rule removes the specified test for the presence of
Mycoplasma to provide flexibility for accommodating new and evolving
technology and capabilities without diminishing public health
protections. Removal of this regulation allows manufacturers of live
virus vaccines produced from in vitro living cell cultures and
inactivated virus vaccines produced from such living cell cultures to
select the most scientifically appropriate Mycoplasma testing method to
assure the safety, purity, and potency of their vaccines.
    These newer technologies can result in higher sensitivity and
specificity of Mycoplasma detection and could reduce the time required
to complete testing for Mycoplasma. Removal of this regulation does not
remove Mycoplasma testing requirements specified in individual BLAs. A
manufacturer of a live virus vaccine produced from in vitro living cell
cultures and inactivated virus vaccines produced from such living cell
cultures will continue to be required to follow the Mycoplasma test
requirements specified in its BLA, unless the BLA was revised to modify
or replace the test through a supplement in accordance with Sec.
601.12(c) (21 CFR 601.12(c)). FDA would review proposed changes to a
manufacturer's approved biologics license in the context of that
particular application to ensure that any such action is appropriate.
    Although the final rule removes the regulation, a manufacturer
continues to be required to test for Mycoplasma as specified in its
BLA. This action provides regulated industry with flexibility, as
appropriate, to employ advances in science and technology as they
become available, without diminishing public health protections. As
appropriate, the Agency will describe the appropriate tests for
particular products in manufacturers' BLAs.

C. Summary of Comments to the Proposed Rule

    We received comments on the proposed rule from individuals and
industry submitters. The comments were generally supportive, with some
comments suggesting new testing procedures be proposed. These comments
are further summarized in section IV.

III. Legal Authority

    We are issuing this final rule under the biological products
provisions of the PHS Act (42 U.S.C. 216, 262, 263, 263a, and 264) and
the drugs and general administrative provisions of the FD&C Act (21
U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c, 360d, 360h, 360i, 371,
372, 374, and 381). Under these provisions of the PHS Act and the FD&C
Act, we have the authority to issue and enforce regulations designed to
ensure that biological products are safe, pure, and potent, and prevent
the

introduction, transmission, and spread of communicable disease.

IV. Comments on the Proposed Rule and FDA Response

A. Introduction

    We received comments on the proposed rule from individuals and
industry submitters. We describe and respond to the comments in section
IV.B. We have combined comments on similar topics and have numbered
each comment to help distinguish between different comments. The number
assigned to each comment or comment topic is purely for organizational
purposes and does not signify the comment's value or importance or the
order in which comments were received.

B. Comments and FDA Response

    (Comment 1) One comment requested that FDA not finalize the rule,
but instead amend the proposal to revoke the current test for
Mycoplasma. The commenter proposed that FDA include methodologies on
newer tests and how they are distinguishable from the present test;
comparable data on the accuracy of Mycoplasma detection between the
present and newer tests, and any other additional information that
would support FDA's argument that the newer tests are more efficient.
    (Response 1) FDA interprets this comment to support the proposal to
remove the currently described methodology and to amend the regulation
to specify alternative acceptable tests. The purpose of this rulemaking
is to permit manufacturers of live virus vaccines produced from in
vitro living cell cultures and inactivated virus vaccines produced from
such living cell cultures to select the most scientifically appropriate
Mycoplasma testing method to assure the safety, purity, and potency of
their vaccines. Thus, FDA declines to amend the regulation to specify
alternative acceptable tests because this would not achieve the goal of
allowing flexibility, as appropriate, to employ advances in science and
technology as they become available without diminishing public health
protections. However, FDA acknowledges that guidance is helpful to
describe FDA's current thinking on alternative methods of testing for
Mycoplasma in manufacturing samples of live virus vaccines and
inactivated virus vaccines produced from in vitro living cell cultures.
FDA notes that recommended alternative methods for Mycoplasma testing
for viral vaccines are described in ``Guidance for Industry:
Characterization and Qualification of Cell Substrates and Other
Biological Materials Used in the Production of Viral Vaccines for
Infectious Disease Indications'' (February 2010) (https://www.fda.gov/media/78428/download).
    (Comment 2) One comment supported the proposed rule.
    (Response 2) We acknowledge and appreciate the supportive comment.
    (Comment 3) One comment did not comment specifically on finalizing
the rule, but stated that with changes to technology, it makes sense to
update testing procedures. The comment stated that ``a list of the new
proposed test methods would be beneficial to compare the overall
benefits and disadvantages.'' Another comment suggested that if the
rule is finalized, FDA should provide guidance for alternative methods
of testing for Mycoplasma.
    (Response 3) While the comment states that it would be helpful to
have a list of new proposed test methods, FDA does not believe the
regulation should be amended to include such a list because that list
could become outdated. License holders are welcome to discuss with FDA
proposals to change their existing test methods and to submit proposals
to FDA to revise the current test methods in use.
    FDA also acknowledges that guidance is helpful to describe FDA's
current thinking on acceptable alternative methods of testing for
Mycoplasma in manufacturing samples of live virus vaccines and
inactivated virus vaccines produced from in vitro living cell cultures.
FDA notes that recommended alternative methods for Mycoplasma testing
for viral vaccines are described in ``Guidance for Industry:
Characterization and Qualification of Cell Substrates and Other
Biological Materials Used in the Production of Viral Vaccines for
Infectious Disease Indications'' (February 2010) (https://www.fda.gov/media/78428/download).
    (Comment 4) One comment strongly supported removal of the
regulation and agreed that more sensitive test methods exist; however,
the commenter wanted the scope of the impact to be expanded to include
all biological product manufacturers.
    (Response 4) We acknowledge and appreciate the supportive comment.
The request to expand the revocation to include all biological product
manufacturers is beyond the scope of this rule making because Sec.
610.30 pertains to manufacturers of live virus vaccines and inactivated
virus vaccines produced from in vitro living cell cultures.

V. Effective Date

    The final rule will become effective 30 days after the date of
publication in the Federal Register.

VI. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, Executive Order 13771, the
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and
13563 direct us to assess all costs and benefits of available
regulatory alternatives and, when regulation is necessary, to select
regulatory approaches that maximize net benefits (including potential
economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). Executive Order 13771
requires that the costs associated with significant new regulations
``shall, to the extent permitted by law, be offset by the elimination
of existing costs associated with at least two prior regulations.'' We
believe that this final rule is not a significant regulatory action as
defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory
options that would minimize any significant impact of a rule on small
entities. Because this rule would increase flexibility and does not add
any new regulatory responsibilities, we certify that the final rule
will not have a significant economic impact on a substantial number of
small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires
us to prepare a written statement, which includes an assessment of
anticipated costs and benefits, before issuing ``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 $154
million, using the most current (2018) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.

B. Summary of Costs and Benefits

    This final rule will amend the biologics regulations under Sec.
610.30 by removing the specified test for Mycoplasma in the production
of live virus vaccines produced from in vitro living cell cultures and
inactivated virus

vaccines produced from such living cell cultures.
    Removing the Sec.  610.30 Test for Mycoplasma will provide
manufacturers with the flexibility to determine the most appropriate
and effective Mycoplasma testing methods. FDA guidance dated after
Sec.  610.30, codified in 1973 (November 20, 1973, 38 FR 32056),
outlines up-to-date scientific practices to identify Mycoplasma in
production of live virus vaccines produced from in vitro living cell
cultures and inactivated virus vaccines produced from in vitro living
cell cultures. In practice, a vaccine manufacturer can change its
procedures at any time with submission and prior approval of a
supplement to its BLA. As a result, we do not expect the repeal of the
Sec.  610.30 Test for Mycoplasma to significantly influence the
behavior or procedures of vaccine manufacturers.
    Because manufacturers already have the ability to pursue
alternative testing procedures, we anticipate no measurable change in
industry or FDA behavior from this final rulemaking. We therefore
expect the elimination of the Sec.  610.30 Test for Mycoplasma to be
cost neutral. This final rule will therefore produce no quantifiable
savings, costs, or transfers. We also expect no public health benefits
to be lost as a result of this revocation. Finally, we note that this
final rulemaking may drive some manufacturers to streamline their
procedures and search for more efficient Mycoplasma testing methods.
This optimization may produce some unquantifiable efficiencies.

                                      Table 1--Summary of Benefits, Costs and Distributional Effects of Final Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Units
                                             Primary        Low          High    ---------------------------------------
                 Category                    estimate     estimate     estimate       Year       Discount      Period                 Notes
                                                                                dollars     rate  (%)     covered
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized...........................  ...........  ...........  ...........  ...........            7               ...............................
    Monetized $millions/year.............  ...........  ...........  ...........  ...........            3               ...............................
    Annualized...........................  ...........  ...........  ...........  ...........            7               ...............................
    Quantified...........................  ...........  ...........  ...........  ...........            3               ...............................
                                          --------------------------------------------------------------------------------------------------------------
    Qualitative..........................  Benefits to manufacturers from         ...........  ...........               ...............................
                                           flexibility to determine appropriate
                                           and effective Mycoplasma testing
                                           methods.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized...........................  ...........  ...........  ...........  ...........            7               ...............................
    Monetized $millions/year.............  ...........  ...........  ...........  ...........            3               ...............................
    Annualized...........................  ...........  ...........  ...........  ...........            7               ...............................
    Quantified...........................  ...........  ...........  ...........  ...........            3               ...............................
                                          --------------------------------------------------------------------------------------------------------------
    Qualitative..........................  Costs to manufacturers to change       ...........  ...........               ...............................
                                           Mycoplasma testing methods, if
                                           voluntarily pursued.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal..............................  ...........  ...........  ...........  ...........            7               ...............................
    Annualized...........................  ...........  ...........  ...........  ...........            3               ...............................
    Monetized $millions/year.............  ...........  ...........  ...........  ...........  ...........               ...............................
                                          --------------------------------------------------------------------------------------------------------------
    From/To..............................  From:
                                           To:
                                          --------------------------------------------------------------------------------------------------------------
    Other................................  ...........  ...........  ...........  ...........            7               ...............................
    Annualized...........................  ...........  ...........  ...........  ...........            3               ...............................
    Monetized $millions/year.............  ...........  ...........  ...........  ...........  ...........               ...............................
                                          --------------------------------------------------------------------------------------------------------------
    From/To..............................  From:
                                           To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: None.
    Small Business: None.
    Wages: None.
    Growth: None.
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in table 2 we present
annualized values of costs and cost savings over an infinite time
horizon. There are no quantifiable costs or cost savings from this
rule. This final rule would be considered a deregulatory action under
Executive Order 13771.

                                  Table 2--Executive Order 13771 Summary Table
                           [in $ Millions 2016 Dollars, Over an Infinite Time Horizon]
----------------------------------------------------------------------------------------------------------------
                                                                      Primary          Lower           Upper
                              Item                                estimate  (7%)  estimate  (7%)  estimate  (7%)
----------------------------------------------------------------------------------------------------------------
Present Value of Costs..........................................  ..............  ..............  ..............
Present Value of Cost Savings...................................  ..............  ..............  ..............
Present Value of Net Costs......................................  ..............  ..............  ..............
Annualized Costs................................................  ..............  ..............  ..............
Annualized Cost Savings.........................................  ..............  ..............  ..............
Annualized Net Costs............................................  ..............  ..............  ..............
----------------------------------------------------------------------------------------------------------------

    We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 1) and at
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.

VII. Analysis of Environmental Impact

    We have determined under 21 CFR 25.31(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.

VIII. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

IX. Federalism

    We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. We have 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, we conclude 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.

X. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set
forth in Executive Order 13175. We have determined that the rule does
not contain policies that have substantial direct effects 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. Accordingly, we
conclude that the rule does not contain policies that have tribal
implications as defined in the Executive Order and, consequently, a
tribal summary impact statement is not required.

XI. Reference

    The following reference is on display at the Dockets Management
Staff (see ADDRESSES) and is available for viewing by interested
persons between 9 a.m. and 4 p.m. Monday through Friday; it is also
available electronically at https://www.regulations.gov. FDA has
verified the website address, as of the date this document publishes in
the Federal Register, but websites are subject to change over time.

1. FDA/Economics Staff, ``Elimination of the 21 CFR 610.30 Test for
Mycoplasma Preliminary Regulatory Impact Analysis, Preliminary
Regulatory Flexibility Analysis, Unfunded Mandates Reform Act
Analysis,'' 2018. (Available at https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.)

List of Subjects in 21 CFR part 610

    Biologics, Labeling, Reporting and recordkeeping requirements.

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

PART 610--GENERAL BIOLOGICAL PRODUCTS STANDARDS

0
1. The authority citation for part 610 continues to read as follows:

    Authority: 21 U.S.C. 321, 331, 351, 352, 353, 355, 360, 360c,
360d, 360h, 360i, 371, 372, 374, 381; 42 U.S.C. 216, 262, 263, 263a,
264.

Subpart D--[Removed and Reserved]

0
2. Remove and reserve subpart D, consisting of Sec.  610.30.

    Dated: July 29, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
[FR Doc. 2020-17085 Filed 8-20-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 211 (Wednesday, October 31, 2012)]
[Notices]
[Page 65874]
[FR Doc No: 2012-26721]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER13-167-000]

Caerus Energy, LLC; Supplemental Notice That Initial Market-Based
Rate Filing Includes Request For Blanket Section 204 Authorization

    This is a supplemental notice in the above-referenced proceeding of
Caerus Energy, LLC's application for market-based rate authority, with
an accompanying rate tariff, noting that such application includes a
request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE., Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is November 13, 2012.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with Internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
14 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for review in the Commission's
Public Reference Room in Washington, DC. There is an eSubscription link
on the Web site that enables subscribers to receive email notification
when a document is added to a subscribed docket(s). For assistance with
any FERC Online service, please email<EMAIL_ADDRESS>or
call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 24, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-26721 Filed 10-30-12; 8:45 am]
BILLING CODE 6717-01-P


Debra Edwards, Ph.D., Director

Office of Prevention, Pesticides & Toxic Substances

U.S. Environmental Protection Agency

Washington, DC 20460

Re: Fourth Addendum to Sinapu et al.’s Petition to Ban Sodium Cyanide
(M-44) and Sodium Flouroacetate (Livestock Protection Collars)

Dear Dr. Edwards:

This week we received a significant new document from the Environmental
Protection Agency (EPA) in response to our Freedom of Information Act
request.  We hope that EPA decision makers will carefully consider the
attached notice of warning letter as part of its deliberations on the
above-captioned petition.

On March 2008, the EPA dispatched a notice of warning letter to
USDA-Wildlife Services because the federal predator-killing agency had
failed to properly place M-44s sodium-cyanide ejecting devices in
accordance with the Federal Fungicide, Insectide, and Rodenticide
Act’s (FIFRA) 26 use restrictions for M-44s.

As a result of Wildlife Services’ negligence, Sam Pollock (a U.S. Fish
and Wildlife Service biologist), who was rabbit hunting on federal
public lands with his dog, Jenna, was exposed to sodium cyanide after
Jenna had asphyxiated and died.  Apparently, Jenna triggered an unmarked
M-44 device.  According to Mr. Pollock, the device was placed on public
roadway under a powerline in an area known as Brough Reservoir.  Mr.
Pollock witnessed Jenna gagging, frothing, and vomiting and saw the
spent M-44.  Jenna died in Mr. Pollock’s arms approximately 90 seconds
later.  Mr. Pollock hoisted Jenna over his shoulder and carried her
carcass for two miles back to his truck.  Soon after, Mr. Pollock
reported that he felt faint and noticed a metallic taste in his mouth.
Jenna was buried in Mr. Pollock’s back yard.

On behalf of the EPA, the Utah Department of Agriculture and Food
investigated this incident—one month later.  The state inspector went
to the Brough Reservoir without Mr. Pollock’s aid.  Therefore, the
state agent could not know the precise location where Jenna was killed.
Yet, he was able to take photographs, and one allegedly showed that the
device had been placed on the road, and had been marked—something Mr.
Pollock adamantly disputes.  Utah Department of Agriculture erroneously
determined, despite its own photographic evidence, that the device was
not on a roadway.  The EPA’s March 2008 letter, rightfully disputes
this finding.  The notice of warning also found that Wildlife Services
had recklessly placed the M-44 device in a pubic recreation area in
violation of FIFRA.

As we have documented as part of this administrative process, this type
of negligence seems to be a pattern and practice for Wildlife Services.
These devices are unnecessary to protect livestock and yet they pose
imminent harm to people, their pets, and to a whole host of species.
Therefore, we urge you to ban sodium cyanide (and Compound 1080) as a
means to kill native carnivores.

Sincerely yours,

Wendy Keefover-Ring, Director

Carnivore Protection

WildEarth Guardians

1911-11th Street, Ste. 103

Boulder, CO 80302

303.447.8655, Ext. 1#

<EMAIL_ADDRESS>

 In January 2008, Sinapu and Forest Guardians joined forces to become
WildEarth Guardians.

	May 29, 2008