[Federal Register Volume 86, Number 124 (Thursday, July 1, 2021)]
[Rules and Regulations]
[Pages 34933-34936]
[FR Doc No: 2021-14158]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2021-0540; Project Identifier MCAI-2021-00694-T;
Amendment 39-21635; AD 2021-14-08]
RIN 2120-AA64

Airworthiness Directives; Airbus SAS Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; request for comments.

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SUMMARY: The FAA is adopting a new airworthiness directive (AD) for all
Airbus SAS Model A319-151N, A319-153N, A319-171N, A320-251N, A320-252N,
A320-253N, A320-271N, A320-272N, A320-273N, A321-251N, A321-251NX,
A321-252N, A321-252NX, A321-253N, A321-253NX, A321-271N, A321-271NX,
A321-272N and A321-272NX airplanes. This AD was prompted by reports of
an increasing number of operational disruptions due to airspeed
discrepancies. This AD requires revising the existing airplane flight
manual (AFM) to include a procedure to reinforce the airspeed check
during the take-off phase and provide instructions to abort take-off in
certain cases, as specified in a European Union Aviation Safety Agency
(EASA) AD, which is incorporated by reference. The FAA is issuing this
AD to address the unsafe condition on these products.

DATES: This AD becomes effective July 1, 2021.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of July 1,
2021.
    The FAA must receive comments on this AD by August 16, 2021.

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 https://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 EASA material incorporated by reference (IBR) in this AD,
contact EASA, Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone
+49 221 8999 000; email<EMAIL_ADDRESS>internet
www.easa.europa.eu. You may find this IBR material on the EASA website
at https://ad.easa.europa.eu. You may view this IBR material at the
FAA, Airworthiness Products Section, Operational Safety Branch, 2200
South 216th St., Des Moines, WA. For information on the availability of
this material at the FAA, call<PHONE_NUMBER>. It is also available in
the AD docket on the internet at https://www.regulations.gov by
searching for

and locating Docket No. FAA-2021-0540.

Examining the AD Docket

    You may examine the AD docket on the internet at https://www.regulations.gov by searching for and locating Docket No. FAA-2021-
0540; or in person at Docket Operations between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays. The AD docket contains
this AD, any comments received, and other information. The street
address for Docket Operations is listed above.

FOR FURTHER INFORMATION CONTACT: Sanjay Ralhan, Aerospace Engineer,
Large Aircraft Section, International Validation Branch, FAA, 2200
South 216th St., Des Moines, WA 98198; telephone and fax<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Background

    EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2021-0150, dated June 21, 2021;
corrected June 25, 2021 (EASA AD 2021-0150) (also referred to as the
Mandatory Continuing Airworthiness Information, or the MCAI), to
correct an unsafe condition for all Airbus SAS Model A319-151N, A319-
153N, A319-171N, A320-251N, A320-252N, A320-253N, A320-271N, A320-272N,
A320-273N, A321-251N, A321-251NX, A321-252N, A321-252NX, A321-253N,
A321-253NX, A321-271N, A321-271NX, A321-272N and A321-272NX airplanes.
    EASA and Airbus issued various communication documents
(respectively EASA Safety Information Bulletin (SIB) 2020-14, Airbus
Operators Information Transmission (OIT) 999.0048/20, Airbus
Operational Training Transmission (OTT) 999.0025/21, and Airbus Flight
Operations Transmission (FOT) 999.0020/21) to remind operators to apply
appropriate procedures for returning airplanes to service from short
term or long term storage/parking, including procedures to inspect the
pitot static system. However, an increasing number of operational
disruptions have been reported, due to contaminated air data system,
caused by lack of application of appropriate maintenance procedures for
returning airplanes to service.
    This AD was prompted by reports of an increasing number of
operational disruptions due to airspeed discrepancies after airplanes
have been parked or stored (a large number of airplanes have been
parked or stored due to the COVID-19 pandemic). Consistent erroneous
airspeed indications (which stands for 2 or 3 pitot probes delivering
erroneous speed information within the same speed range) may adversely
affect airplane response, in particular during the rotation phase. The
FAA is issuing this AD to address airspeed discrepancies, which could
lead to an unstable flight path after take-off, possibly resulting in
reduced control of the airplane. See the MCAI for additional background
information.

Related Service Information Under 1 CFR Part 51

    EASA AD 2021-0150 describes procedures for, among other actions,
revising the AFM to include a procedure to reinforce the airspeed check
during the take-off phase and provide instructions to abort take-off in
certain cases (e.g., an unreliable airspeed situation or certain
airspeed differences).
    This material is reasonably available because the interested
parties have access to it through their normal course of business or by
the means identified in the ADDRESSES section.

FAA's Determination

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to the FAA's bilateral agreement with the State of Design Authority,
the FAA has been notified of the unsafe condition described in the MCAI
referenced above. The FAA is issuing this AD because the FAA evaluated
all pertinent information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Requirements of This AD

    This AD requires accomplishing the actions specified in EASA AD
2021-0150 described previously, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this AD and except as discussed under ``Differences Between this AD and
the MCAI.''

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA developed a process to use some civil aviation
authority (CAA) ADs as the primary source of information for compliance
with requirements for corresponding FAA ADs. The FAA has been
coordinating this process with manufacturers and CAAs. As a result,
EASA AD 2021-0150 is incorporated by reference in this AD. This AD
requires compliance with EASA AD 2021-0150 in its entirety through that
incorporation, except for any differences identified as exceptions in
the regulatory text of this AD. Using common terms that are the same as
the heading of a particular section in EASA AD 2021-0150 does not mean
that operators need comply only with that section. For example, where
the AD requirement refers to ``all required actions and compliance
times,'' compliance with this AD requirement is not limited to the
section titled ``Required Action(s) and Compliance Time(s)'' in EASA AD
2021-0150. Service information required by EASA AD 2021-0150 for
compliance will be available at https://www.regulations.gov by
searching for and locating Docket No. FAA-2021-0540 after this AD is
published.

Differences Between This AD and the MCAI

    Paragraph (3) of EASA AD 2021-0150 requires revising the minimum
equipment list (MEL) to incorporate an EASA master minimum equipment
list (MMEL) change to mandate that the integrated standby instrument
system (ISIS) airspeed indication must be operative. However, the FAA
MMEL does not provide relief for an inoperative ISIS airspeed
indication function. Therefore, paragraph (3) of EASA AD 2021-0150 is
unnecessary for this AD.
    EASA AD 2021-0150 requires operators to ``inform all flight crews''
of revisions to the AFM and thereafter to ``operate the aeroplane
accordingly.'' However, this AD does not specifically require those
actions as those actions are already required by FAA regulations.
    FAA regulations require operators furnish to pilots any changes to
the AFM (ex: 14 CFR 121.137), and to ensure the pilots are familiar
with the AFM (ex: 14 CFR 91.505). As with any other training
requirement, training on the updated AFM content is tracked by the
operators and recorded in each pilot's training record, which is
available for the FAA to review. FAA regulations also require pilots to
follow the procedures in the existing AFM including all updates. 14 CFR
91.9 requires that no person may operate a civil aircraft without
complying with the operating limitations specified in the AFM.
    Therefore, including a requirement in this AD to operate the
airplane according to the revised AFM would be redundant and
unnecessary. Further, compliance with such requirements in

an AD would be impracticable to demonstrate or track on an ongoing
basis; therefore, a requirement to operate the airplane in such a
manner would be unenforceable.

FAA's Justification and Determination of the Effective Date

    Section 553(b)(3)(B) of the Administrative Procedure Act (APA) (5
U.S.C. 551 et seq.) authorizes agencies to dispense with notice and
comment procedures for rules when the agency, for ``good cause,'' finds
that those procedures are ``impracticable, unnecessary, or contrary to
the public interest.'' Under this section, an agency, upon finding good
cause, may issue a final rule without providing notice and seeking
comment prior to issuance. Further, section 553(d) of the APA
authorizes agencies to make rules effective in less than thirty days,
upon a finding of good cause.
    An unsafe condition exists that requires the immediate adoption of
this AD without providing an opportunity for public comments prior to
adoption. The FAA has found that the risk to the flying public
justifies forgoing notice and comment prior to adoption of this rule
because consistent erroneous airspeed indications may adversely affect
airplane response, in particular during the rotation phase. This unsafe
condition is particularly prevalent in the large number of airplanes
that are returning to service after airplanes have been parked or
stored due to the COVID-19 pandemic. Without reinforcing the airspeed
check and providing instructions to abort take-off in certain cases,
airspeed discrepancies could lead to an unstable flight path after
take-off, possibly resulting in reduced control of the airplane.
Accordingly, notice and opportunity for prior public comment are
impracticable and contrary to the public interest pursuant to 5 U.S.C.
553(b)(3)(B).
    In addition, the FAA finds that good cause exists pursuant to 5
U.S.C. 553(d) for making this amendment effective in less than 30 days,
for the same reasons the FAA found good cause to forgo notice and
comment.

Comments Invited

    The FAA invites you to send any written relevant data, views, or
arguments about this AD. Send your comments to an address listed under
ADDRESSES. Include ``Docket No. FAA-2021-0540; Project Identifier MCAI-
2021-00694-T'' at the beginning of your comments. The most helpful
comments reference a specific portion of the final rule, explain the
reason for any recommended change, and include supporting data. The FAA
will consider all comments received by the closing date and may amend
this final rule because of those comments.
    Except for Confidential Business Information (CBI) as described in
the following paragraph, and other information as described in 14 CFR
11.35, the FAA will post all comments received, without change, to
https://www.regulations.gov, including any personal information you
provide. The agency will also post a report summarizing each
substantive verbal contact received about this final rule.

Confidential Business Information

    CBI is commercial or financial information that is both customarily
and actually treated as private by its owner. Under the Freedom of
Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from public
disclosure. If your comments responsive to this AD contain commercial
or financial information that is customarily treated as private, that
you actually treat as private, and that is relevant or responsive to
this AD, it is important that you clearly designate the submitted
comments as CBI. Please mark each page of your submission containing
CBI as ``PROPIN.'' The FAA will treat such marked submissions as
confidential under the FOIA, and they will not be placed in the public
docket of this AD. Submissions containing CBI should be sent to Sanjay
Ralhan, Aerospace Engineer, Large Aircraft Section, International
Validation Branch, FAA, 2200 South 216th St., Des Moines, WA 98198;
telephone and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>Any
commentary that the FAA receives which is not specifically designated
as CBI will be placed in the public docket for this rulemaking.

Explanation of Special Flight Permit Limitation

    Once the compliance time specified in this AD has passed, special
flight permits, as described in 14 CFR 21.197 and 21.199, are not
allowed. As a result of the COVID-19 pandemic, a large numbers of
airplanes have been put in storage. For those airplanes removed from
storage after the compliance time specified in this AD has passed,
operators must incorporate the AFM revision required by this AD before
further flight.

Interim Action

    The FAA considers this AD interim action and further AD action
might follow.

Regulatory Flexibility Act (RFA)

    The requirements of the RFA do not apply when an agency finds good
cause pursuant to 5 U.S.C. 553 to adopt a rule without prior notice and
comment. Because the FAA has determined that it has good cause to adopt
this rule without notice and comment, RFA analysis is not required.

Costs of Compliance

    The FAA estimates that this AD affects 204 airplanes of U.S.
registry. The FAA estimates the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
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                                                                                Cost per       Cost on U.S.
                          Labor cost                              Parts cost        product         operators
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1 work-hour x $85 per hour = $85.............................              $0              $85          $17,340
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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.
    The FAA is 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

    The FAA determined that 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, and
    (2) Will not affect intrastate aviation in Alaska.

List of Subjects in 14 CFR Part 39

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

Adoption of the Amendment

    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 airworthiness
directive:

2021-14-08 Airbus SAS: Amendment 39-21635; Docket No. FAA-2021-0540;
Project Identifier MCAI-2021-00694-T.

(a) Effective Date

    This airworthiness directive (AD) becomes effective July 1,
2021.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to all Airbus SAS Model A319-151N, A319-153N,
A319-171N, A320-251N, A320-252N, A320-253N, A320-271N, A320-272N,
A320-273N, A321-251N, A321-251NX, A321-252N, A321-252NX, A321-253N,
A321-253NX, A321-271N, A321-271NX, A321-272N and A321-272NX
airplanes, certificated in any category.

(d) Subject

    Air Transport Association (ATA) of America Code 34, Navigation.

(e) Reason

    This AD was prompted by reports of an increasing number of
operational disruptions due to airspeed discrepancies that have
occurred due to the large number of airplanes returning to service
after airplanes have been parked or stored (a large number of
airplanes have been parked or stored due to the COVID-19 pandemic).
The FAA is issuing this AD to address airspeed discrepancies, which
could lead to an unstable flight path after take-off, possibly
resulting in reduced control of the airplane.

(f) Compliance

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

(g) Requirements

    Except as specified in paragraph (h) of this AD: Comply with all
required actions and compliance times specified in, and in
accordance with, European Union Aviation Safety Agency (EASA) AD
2021-0150, dated June 21, 2021; corrected June 25, 2021 (EASA AD
2021-0150).

(h) Exceptions to EASA AD 2021-0150

    (1) Where EASA AD 2021-0150 refers to its effective date, this
AD requires using the effective date of this AD.
    (2) Paragraph (1) of EASA AD 2021-0150 specifies amending ``the
applicable AFM [airplane flight manual],'' but this AD requires
amending ``the existing applicable AFM and applicable corresponding
operational procedures.''
    (3) Paragraph (3) of EASA AD 2021-0150 does not apply to this
AD.
    (4) The ``Remarks'' section of EASA AD 2021-0150 does not apply
to this AD.
    (5) Where paragraph (1) of EASA AD 2021-0150 specifies to
``inform all flight crews, and, thereafter, operate the aeroplane
accordingly,'' this AD does not require those actions as those
actions are already required by existing FAA operating regulations.

(i) Special Flight Permit

    Special flight permits, as described in 14 CFR 21.197 and
21.199, are not allowed after 7 days after the effective date of
this AD unless the AFM revision required by paragraph (g) of this AD
is accomplished.

(j) Other FAA AD Provisions

    The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Large Aircraft Section, International Validation Branch, 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 responsible Flight
Standards Office, as appropriate. If sending information directly to
the Large Aircraft Section, International Validation Branch, send it
to the attention of the person identified in paragraph (k) of this
AD. Information may be emailed to<EMAIL_ADDRESS>
Before using any approved AMOC, notify your appropriate principal
inspector, or lacking a principal inspector, the manager of the
responsible Flight Standards Office.
    (2) Contacting the Manufacturer: For any requirement in this AD
to obtain instructions from a manufacturer, the instructions must be
accomplished using a method approved by the Manager, Large Aircraft
Section, International Validation Branch, FAA; or EASA; or Airbus
SAS's EASA Design Organization Approval (DOA). If approved by the
DOA, the approval must include the DOA-authorized signature.
    (3) Required for Compliance (RC): Except as required by
paragraph (j)(2) of this AD, if any service information contains
procedures or tests that are identified as RC, those procedures and
tests must be done to comply with this AD; any procedures or tests
that are not identified as RC are recommended. Those procedures and
tests that are not identified as RC may be deviated from using
accepted methods in accordance with the operator's maintenance or
inspection program without obtaining approval of an AMOC, provided
the procedures and tests identified as RC can be done and the
airplane can be put back in an airworthy condition. Any
substitutions or changes to procedures or tests identified as RC
require approval of an AMOC.

(k) Related Information

    For more information about this AD, contact Sanjay Ralhan,
Aerospace Engineer, Large Aircraft Section, International Validation
Branch, FAA, 2200 South 216th St., Des Moines, WA 98198; telephone
and fax<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(l) Material Incorporated by Reference

    (1) The Director of the Federal Register approved the
incorporation by reference (IBR) of the service information listed
in this paragraph under 5 U.S.C. 552(a) and 1 CFR part 51.
    (2) You must use this service information as applicable to do
the actions required by this AD, unless this AD specifies otherwise.
    (i) European Union Aviation Safety Agency (EASA) AD 2021-0150,
dated June 21, 2021; corrected June 25, 2021.
    (ii) [Reserved]
    (3) For EASA AD 2021-0150, contact EASA, Konrad-Adenauer-Ufer 3,
50668 Cologne, Germany; telephone +49 221 8999 000; email
<EMAIL_ADDRESS>internet www.easa.europa.eu. You may find this
EASA AD on the EASA website at https://ad.easa.europa.eu.
    (4) You may view this material at the FAA, Airworthiness
Products Section, Operational Safety Branch, 2200 South 216th St.,
Des Moines, WA. For information on the availability of this material
at the FAA, call<PHONE_NUMBER>. This material may be found in the AD
docket on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2021-0540.
    (5) You may view this material that is incorporated by reference
at the National Archives and Records Administration (NARA). For
information on the availability of this material at NARA, email
<EMAIL_ADDRESS>or go to: https://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued on June 28, 2021.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2021-14158 Filed 6-29-21; 11:15 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 89 (Monday, May 9, 2011)]
[Rules and Regulations]
[Pages 26615-26616]
[FR Doc No: 2011-11125]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2007-1073; FRL-9292-4]

Revisions to the California State Implementation Plan, Imperial
County Air Pollution Control District (ICAPCD)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: EPA is finalizing approval of revisions to the Imperial County
Air Pollution Control District portion of the California State
Implementation Plan (SIP). These revisions were proposed in the Federal
Register on February 9, 2011 and concern New Source Review (NSR)
permitting requirements and exemptions for various air pollution
sources. We are approving local rules that regulate these emission
sources under the Clean Air Act as amended in 1990 (CAA or the Act).

DATES: Effective Date: This rule is effective on June 8, 2011.

ADDRESSES: EPA has established docket number EPA-R09-OAR-2007-1073 for
this action. Generally, documents in the docket for this action are
available electronically at http://www.regulations.gov or in hard copy
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. While
all documents in the docket are listed at http://www.regulations.gov,
some information may be publicly available only at the hard copy
location (e.g., copyrighted material, large maps, multi-volume
reports), and some may not be available in either location (e.g.,
confidential business information (CBI)). To inspect the hard copy
materials, please schedule an appointment during normal business hours
with the contact listed in the FOR FURTHER INFORMATION CONTACT section.

FOR FURTHER INFORMATION CONTACT: Laura Yannayon, EPA Region IX, (415)
972-3534<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to EPA.

Table of Contents

I. Proposed Action
II. Public Comments and EPA Responses
III. EPA Action
IV. Statutory and Executive Order Reviews

I. Proposed Action

    On February 9, 2011 (76 FR 7142), EPA proposed to approve the
following rules into the California SIP.

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           Local agency                    Rule No.              Rule title           Amended        Submitted
----------------------------------------------------------------------------------------------------------------
ICAPCD............................  201..................  Permits Required.....        10/10/06        08/24/07
ICAPCD............................  202..................  Exemptions...........        10/10/06        08/24/07
----------------------------------------------------------------------------------------------------------------

    We proposed to approve these rules because we determined that they
complied with the relevant CAA requirements. Our proposed action
contains more information on the rules and our evaluation.

II. Public Comments and EPA Responses

    EPA's proposed action provided a 30-day public comment period.
During this period, we received no comments.

III. EPA Action

    No comments were submitted that change our assessment that the
submitted rules comply with the relevant CAA requirements. Therefore,
as authorized in section 110(k)(3) of the Act, EPA is fully approving
these rules into the California SIP.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, EPA's role is to approve State
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves State law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by State law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Order
12866 (58 FR 51735, October 4, 1993);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);

     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     Does not provide EPA with the discretionary authority to
address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, this rule does not have tribal implications as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000),
because the SIP is not approved to apply in Indian country located in
the State, and EPA notes that it will not impose substantial direct
costs on tribal governments or preempt tribal law.
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by July 8, 2011. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Nitrogen Dioxide, Ozone,
Particulate matter, Reporting and recordkeeping requirements, Volatile
organic compounds.

    Dated: March 31, 2011.
Jared Blumenfeld,
Regional Administrator, Region IX.
    Part 52, Chapter I, Title 40 of the Code of Federal Regulations is
amended as follows:

PART 52--[AMENDED]

0
1. The authority citation for Part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart F--California

0
2. Section 52.220 is amended by adding paragraphs (c)(351)(i)(A)(3) and
(c)(351) (i)(A)(4) to read as follows:

Sec.  52.220  Identification of plan.

* * * * *
    (c) * * *
    (351) * * *
    (i) * * *
    (A) * * *
    (3) Rule 201, ``Permits Required'' amended on October 10, 2006.
    (4) Rule 202, ``Exemptions'' amended on October 10, 2006.
* * * * *
[FR Doc. 2011-11125 Filed 5-6-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 2, 2008 (Volume 73, Number 232)]
[Notices]
[Page 73319-73320]
[DOCID:fr02de08-61]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings

November 24, 2008.
    Take notice that the Commission has received the following Natural
Gas Pipeline Rate and Refund Report filings:
    Docket Numbers: RP96-200-201.
    Applicants: CenterPoint Energy Gas Transmission Co.
    Description: CenterPoint Energy Gas Transmission Company submits a
negotiated rate agreement between CEGT and Southwestern Electric Power.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0140.
    Comment Date: 5 p.m. Eastern Time on Monday, December 1, 2008.

    Docket Numbers: RP00-157-022.
    Applicants: Kern River Gas Transmission Company.
    Description: Second Refund Report Reflecting refunds issued on
October 31, 2008, pursuant to Offer of Settlement and Stipulation filed
on September 30, 2008.
    Filed Date: 11/19/2008.
    Accession Number: 20081119-5109.
    Comment Date: 5 p.m. Eastern Time on Monday, December 1, 2008.

    Docket Numbers: RP09-87-000.
    Applicants: Southern Star Central Gas Pipeline, Inc.
    Description: Annual Operational Flow Order Report.
    Filed Date: 11/19/2008.
    Accession Number: 20081119-5126.
    Comment Date: 5 p.m. Eastern Time on Monday, December 1, 2008.

    Docket Numbers: RP09-88-000.
    Applicants: ANR Pipeline Company.
    Description: ANT Pipeline Company submits Seventh Revised Sheet 76
for inclusion in ANR's FERC Gas Tariff, Original Volume 2.
    Filed Date: 11/19/2008.
    Accession Number: 20081120-0139.
    Comment Date: 5 p.m. Eastern Time on Monday, December 1, 2008.

    Docket Numbers: RP09-89-000.
    Applicants: CenterPoint Energy Gas Transmission Co.
    Description: CenterPoint Energy Gas Transmission Company submits
Sixth Revised Sheet 1 et. al. to FERC Gas Tariff, Sixth Revised Volume
1, to be effective 12/20/08.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0151.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-90-000.
    Applicants: East Tennessee Natural Gas, LLC.
    Description: East Tennessee Natural Gas, LLC submits Fifth Revised
Sheet 1 et. al to FERC Gas Tariff, Third Revised Volume 1, to be
effective 1/1/09.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0150.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-91-000.
    Applicants: Northwest Pipeline GP.
    Description: Northwest Pipeline GP submits Second Revised Sheet 5
et. al. to FERC Gas Tariff, Fourth Revised Volume 1.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0148.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-92-000.
    Applicants: Dominion Transmission, Inc.
    Description: Dominion Transmission, Inc submits Sheet 0, Third
Revised Sheet 1092 et. al. to FERC Gas Tariff, Third Revised Volume 1,
to be effective 12/22/08.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0147.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-93-000.
    Applicants: Southeast Supply Header, LLC.
    Description: Southeast Supply Header, LLC submits First Revised
Sheet 323 et. al. to FERC Gas Tariff, Original Volume 1, to be
effective 1/1/09.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0146.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-94-000.
    Applicants: Dominion South Pipeline Company, LP.
    Description: Dominion South Pipeline Company, LP submits First
Revised Sheet 1062 et al to FERC Gas Tariff, Original Volume 1, to be
effective 12/22/08.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0141.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-95-000.
    Applicants: Dominion Cove Point LNG, LP.
    Description: Dominion Cove Point LNG, LP submits Sheet 0, Fourth
Revised Sheet 400, and First Revised Sheet 407 to FERC Gas Tariff,
Original Volume 1, to be effective 12/22/08.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0142.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-96-000.
    Applicants: Saltville Gas Storage Company L.L.C.
    Description: Saltville Gas Storage Company, LLC submits First
Revised Second Revised Sheet 111A et al. to FERC Gas Tariff, Original
Volume 1, to be effective 1/1/09.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0143.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-97-000.
    Applicants: Algonquin Gas Transmission Company.
    Description: Algonquin Gas Transmission, LLC submits Third Revised
Sheet 509 et al. to FERC Gas Tariff, Fifth Revised Volume 1, to be
effective 1/1/09.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0144.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-98-000.
    Applicants: Texas Eastern Transmission LP.
    Description: Texas Eastern Transmission, LP submits Second Revised
Sheet 512C et al. to FERC Gas Tariff, Seventh Revised Volume 1, to be
effective 1/1/09.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0145.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-99-000.
    Applicants: Egan Hub Storage, LLC.
    Description: Egan Hub Storage, LLC submits Fourth Revised Sheet 109
et al. to its FERC Gas Tariff, First Revised Volume 1, to be effective
1/1/09.
    Filed Date: 11/20/2008.
    Accession Number: 20081124-0149.
    Comment Date: 5 p.m. Eastern Time on Tuesday, December 2, 2008.

    Docket Numbers: RP09-100-000.
    Applicants: Maritimes & Northeast Pipeline, L.L.C.

    Description: Maritimes & Northeast Pipeline, LLC submits Second
Revised Sheet 138 et al. to FERC Gas Tariff, First Revised Volume 1, to
be effective 1/1/09.
    Filed Date: 11/21/2008.
    Accession Number: 20081121-0191.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: RP09-101-000.
    Applicants: Gas Transmission Northwest Corporation.
    Description: Gas Transmission Northwest Corp. submits Sixteenth
Revised Sheet 4 to be part of its FERC Gas Tariff, Third Revised Volume
1-A.
    Filed Date: 11/21/2008.
    Accession Number: 20081121-0192.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Docket Numbers: RP09-102-000.
    Applicants: Kern River Gas Transmission Company.
    Description: Kern River Gas Transmission Co. submits First Revised
Nineteenth Revised Sheet 5 et al. to its FERC Gas Tariff, Second
Revised Volume 1, to be effective 1/1/09.
    Filed Date: 11/21/2008.
    Accession Number: 20081121-0193.
    Comment Date: 5 p.m. Eastern Time on Wednesday, December 3, 2008.

    Any person desiring to intervene or to protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Rules of Practice and Procedure (18 CFR 385.211 and
385.214) on or before 5 p.m. Eastern time on the specified comment
date. It is not necessary to separately intervene again in a subdocket
related to a compliance filing if you have previously intervened in the
same docket. Protests will be considered by the Commission in
determining the appropriate action to be taken, but will not serve to
make protestants parties to the proceeding. Anyone filing a motion to
intervene or protest must serve a copy of that document on the
Applicant. In reference to filings initiating a new proceeding,
interventions or protests submitted on or before the comment deadline
need not be served on persons other than the Applicant.
    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 St. NE., Washington, DC 20426.
    The filings in the above proceedings 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 e-mail notification
when a document is added to a subscribed dockets(s). For assistance
with any FERC Online service, please e-mail<EMAIL_ADDRESS>
or call<PHONE_NUMBER> (toll free). For TTY, call<PHONE_NUMBER>.

Nathaniel J. Davis, Sr.
Deputy Secretary.
 [FR Doc. E8-28517 Filed 12-1-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 199 (Tuesday, October 19, 2021)]
[Notices]
[Page 57817]
[FR Doc No: 2021-22722]

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

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: RP22-38-000.
    Applicants: Natural Gas Pipeline Company of America LLC.
    Description: Sec.  4(d) Rate Filing: Amendment to a Negotiated Rate
Agreemen Filing-Kiowa Power Partners to be effective 10/13/2021.
    Filed Date: 10/12/21.
    Accession Number: 20211012-5294.
    Comment Date: 5 p.m. ET 10/25/21.

    Docket Numbers: RP22-39-000.
    Applicants: Destin Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: Destin Pipelines Tariff
Housekeeping Filing to be effective 11/13/2021.
    Filed Date: 10/12/21.
    Accession Number: 20211012-5297.
    Comment Date: 5 p.m. ET 10/25/21.

    Docket Numbers: RP22-40-000.
    Applicants: Double E Pipeline, LLC.
    Description: Sec.  4(d) Rate Filing: Double E Pipeline, LLC--
Baseline Tariff Filing to be effective 11/15/2021.
    Filed Date: 10/12/21.
    Accession Number: 20211012-5397.
    Comment Date: 5 p.m. ET 10/25/21.

    Docket Numbers: RP22-41-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Sec.  4(d) Rate Filing: PAL NRA Engie SP371112, JAron
SP371128 & JP Morgan SP371110 to be effective 11/1/2021.
    Filed Date: 10/13/21.
    Accession Number: 20211013-5045.
    Comment Date: 5 p.m. ET 10/25/21.

    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 5:00
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: RP21-1154-001.
    Applicants: Enable Gas Transmission, LLC.
    Description: Tariff Amendment: EGT Filing to Correct Tariff
Record--Effective November 1 2021 to be effective 11/1/2021.
    Filed Date: 10/12/21.
    Accession Number: 20211012-5347.
    Comment Date: 5 p.m. ET 10/25/21.

    Any person desiring to protest in any the above proceedings must
file in accordance with Rule 211 of the Commission's Regulations (18
CFR 385.211) on or before 5:00 p.m. Eastern time on the specified
comment date.
    The filings are accessible in the Commission's eLibrary system
(https://elibrary.ferc.gov/idmws/search/fercgensearch.asp) by querying
the docket number.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: October 13, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-22722 Filed 10-18-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 5, 2008 (Volume 73, Number 235)]
[Notices]
[Page 74168]
[DOCID:fr05de08-75]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13279-000]

Natural Currents Energy Services, LLC; Notice of Preliminary
Permit Applications Accepted for Filing and Soliciting Comment, Motions
To Intervene, and Competing Applications

November 28, 2008.
    On August 11, 2008, Natural Currents Energy Services, LLC filed an
application, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Ventura Ocean Energy Project,
to be located on Long Island Sound and Shelter Island Sound in Suffolk
County, New York.
    The proposed Shelter Island Tidal Energy Project consists of: (1)
65 proposed Red Hawk TISEC generating units having a total installed
capacity of 36.20 megawatts, (2) a proposed transmission line, and (3)
appurtenant facilities. The Natural Currents Energy Services, LLC,
project would have an average annual generation of 14,000 gigawatt-
hours and be sold to a local utility.
    Applicant Contact: Mr. Roger Bason, Natural Currents Energy
Services, 24 Roxanne Boulevard, Highland, New York 12561, phone (845)
691-4009.
    FERC Contact: Robert Bell,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13279) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-28778 Filed 12-4-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 213 (Monday, November 6, 2017)]
[Rules and Regulations]
[Pages 51345-51347]
[FR Doc No: 2017-24098]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1, 117, and 507

[Docket No. FDA-2017-D-5996]

Supply-Chain Program Requirements and Co-Manufacturer Supplier
Approval and Verification for Human Food and Animal Food: Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the availability of a guidance for industry entitled
``Supply-Chain Program Requirements and Co-Manufacturer Supplier
Approval and Verification for Human Food and Animal Food.'' The
guidance announces that we do not intend to take enforcement action
against a receiving facility that is a co-manufacturer and that is not
in compliance with certain supply-chain program requirements in the
``Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based
Preventive Controls for Human Food'' and ``Current Good Manufacturing
Practice, Hazard Analysis, and Risk-Based Preventive Controls for Food
for Animals'' regulations (preventive controls regulations) for food
manufactured for the brand owner, under certain circumstances, until
November 6, 2019. Furthermore, we do not intend to take enforcement
action under the Foreign Supplier Verification Programs (FSVP)
regulation against an importer whose supply-chain program is subject to
enforcement discretion under the preventive controls regulations until
November 6, 2019.

DATES: The announcement of the guidance is published in the Federal
Register on November 6, 2017.

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-2017-D-5996 for ``Supply-Chain Program Requirements and Co-

Manufacturer Supplier Approval and Verification for Human Food and
Animal Food.'' 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.
     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.gpo.gov/fdsys/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.
    You may submit comments on any guidance at any time (see 21CFR
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the
Office of Food Safety, Center for Food Safety and Applied Nutrition
(HFS-300), Food and Drug Administration, 5001 Campus Dr., College Park,
MD 20740. Send two self-addressed adhesive labels to assist that office
in processing your request. See the SUPPLEMENTARY INFORMATION section
for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:
    For questions relating to the guidance as it applies to human food:
Jenny Scott, Center for Food Safety and Applied Nutrition (HFS-300),
Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740,
240-402-2166.
    For questions relating to the guidance as it applies to animal
food: Jeanette Murphy, Center for Veterinary Medicine (HFV-200), Food
and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-
402-6246.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry
entitled ``Supply-Chain Program Requirements and Co-Manufacturer
Supplier Approval and Verification for Human Food and Animal Food:
Guidance for Industry.'' We are issuing this guidance consistent with
our good guidance practices (GGP) regulation (Sec.  10.115 (21 CFR
10.115)). We are implementing this guidance without prior public
comment because we have determined that prior public participation is
not feasible or appropriate (Sec.  10.115(g)(2)). We made this
determination because the guidance represents a less burdensome policy
consistent with the public health. Although this guidance document is
immediately in effect, it remains subject to comment in accordance with
FDA's GGP regulation. This guidance is not subject to Executive Order
12866.
    The guidance is intended for persons who participate in certain
``co-manufacturing'' agreements in the production of human or animal
food. By ``co-manufacturing,'' we mean a contractual arrangement
whereby one party (the brand owner) arranges for a second party (the
co-manufacturer) to manufacture/process human or animal food on behalf
of the first party. The guidance concerns three regulations that we
have established in Title 21 of the Code of Federal Regulations (21
CFR) as part of our implementation of the FDA Food Safety Modernization
Act (FSMA; Pub. L. 111-353). (For more information on the Agency's
implementation of FSMA, see https://www.fda.gov/fsma.) These three
regulations are part 117 (21 CFR part 117) (published in the Federal
Register on September 17, 2015, 80 FR 55908), part 507 (21 CFR part
507) (published in the Federal Register on September 17, 2015, 80 FR
56170), and the FSVP regulation (published in the Federal Register of
November 27, 2015, 80 FR 74226). Subpart G of part 117 and subpart E of
part 507 establish requirements for a supply-chain program for those
raw materials and other ingredients for which a receiving facility has
identified a hazard requiring a supply-chain-applied control.
    Under the FSVP regulation, importers are required to develop,
maintain, and follow a foreign supplier verification program that,
among other things, provides adequate assurance that foreign suppliers
are producing food in compliance with processes and procedures that
provide at least the same level of public health protection as those
required under section 418 of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 350g) (which authorized the supply-chain
programs in parts 117 and 507) (see Sec.  1.502(a) (21 CFR 1.502(a)).
An importer that is a receiving facility subject to section 418 of the
FD&C Act is deemed to be in compliance with the requirements of the
FSVP regulation, except the importer identification requirements in 21
CFR 1.509, if the importer has established and implemented a risk-based
supply-chain program in compliance with part 117, subpart G or part
507, subpart E (Sec.  1.502(c)(3)).
    Under the definition of ``receiving facility'' established in parts
117 and 507, co-manufacturers that are subject to the human food or the
animal food preventive controls requirements and that manufacture/
process a raw material or other ingredient received from a supplier are
receiving facilities. Co-manufacturers that are receiving facilities
that have identified a hazard in a raw material or ingredient requiring
a supply-chain-applied control are required to approve their suppliers
for those raw materials or other ingredients. However, the supply-chain
provisions permit an entity other than the receiving facility (e.g.,
permit the brand owner) to determine, conduct, or both determine and
conduct, appropriate supplier verification activities, provided that
the receiving facility documents its review and assessment of the other
entity's applicable documentation. (See Sec. Sec.  117.415(a)(3) and
507.115(a)(3).) Specifically, the rules allow for a co-manufacturer to
base its verification of suppliers on review of adequate documentation
of the brand owner's supplier verification activities.
    Industry has expressed concerns that the requirements of the
supply-chain program would require revisions to contracts between brand
owners and their suppliers to allow brand owners to share certain
information (e.g., audits of suppliers) with co-manufacturers, and that
establishing new contracts would take a significant period of time,
impeding their ability to meet

compliance dates (Ref. 1). If a contract prevents a co-manufacturer
from being able to review a brand owner's documentation of supplier
verification activities, the co-manufacturer would not be able to
verify suppliers based on its review of that documentation.
Consequently, the co-manufacturer would need to conduct supplier
verification activities (e.g., on-site audits) that might otherwise not
be required.
    To provide time for contracts to be revised to allow co-
manufacturers to review all necessary documentation from the brand
owner, FDA is announcing that, under certain circumstances and on a
temporary basis, we do not intend to take enforcement action against a
receiving facility that is a co-manufacturer, and that is not in
compliance with certain supply-chain program requirements (Sec. Sec.
117.410(d) and 117.415(a)(3) or Sec. Sec.  507.110(d) and
507.115(a)(3)) for food manufactured for the brand owner until November
6, 2019. Furthermore, we do not intend to take enforcement action under
the FSVP regulation against an importer who is relying on Sec.
1.502(c)(3) but whose supply-chain program is subject to enforcement
discretion regarding Sec. Sec.  117.410(d) and 117.415(a)(3) or
Sec. Sec.  507.110(d) and 507.115(a)(3).
    The guidance represents the current thinking of FDA on this topic.
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 statues and regulations.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in part 117 have been approved under OMB
control number 0910-0751. The collections of information in part 507
have been approved under OMB control number 0910-0789.

III. Electronic Access

    Persons with access to the internet may obtain the document at
https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/default.htm, https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/default.htm,
or https://www.regulations.gov. Use the FDA Web sites listed in the
previous sentence to find the most current version of the guidance.

IV. Reference

    The following reference is on display in 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.

1. Letter from Grocery Manufacturers Association to Dr. Stephen
Ostroff, Acting Commissioner of Food and Drugs, February 7, 2017.

    Dated: October 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24098 Filed 11-3-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 181 (Tuesday, September 18, 2012)]
[Notices]
[Page 57564]
[FR Doc No: 2012-22946]

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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: RP12-1018-000.
    Applicants: Wyoming Interstate Company, L.L.C.
    Description: Request for Limited Waiver of Tariff Provisions of
Wyoming Interstate Company, L.L.C. to allow Permanent Release of Off-
System Capacity.
    Filed Date: 9/4/12.
    Accession Number: 20120904-5059.
    Comments Due: 5 p.m. ET 9/17/12.

    Docket Numbers: RP12-1030-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Volume No. 2--Northampton Expansion Project-NegRate/
NonConform Agreements to be effective 11/1/2012.
    Filed Date: 9/11/12.
    Accession Number: 20120911-5049.
    Comments Due: 5 p.m. ET 9/24/12.

    Docket Numbers: RP12-1031-000.
    Applicants: Tennessee Gas Pipeline Company, L.L.C.
    Description: Northampton Expansion Project ``Recourse Rate'' to be
effective 11/1/2012.
    Filed Date: 9/11/12.
    Accession Number: 20120911-5050.
    Comments Due: 5 p.m. ET 9/24/12.

    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.
    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 12, 2012.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2012-22946 Filed 9-17-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 76, Number 46 (Wednesday, March 9, 2011)]
[Proposed Rules]
[Pages 12916-12920]
[FR Doc No: 2011-5145]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 310

[Docket No. FDA-1981-N-0012] (Formerly Docket No. 1981N-0022)
RIN 0910-AF45

Benzocaine; Weight Control Drug Products for Over-the-Counter
Human Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a proposed
rule to reclassify benzocaine from its previously proposed monograph
status (category I) for over-the-counter (OTC) weight control use to
nonmonograph status. Although, in the Federal Register of February 26,
1982, an advanced notice of proposed rulemaking (ANPR) included the
recommendation of an Advisory Panel, consisting of health care
providers from outside FDA, recommended that benzocaine should be
generally recognized as safe and effective (GRASE) for weight control,
this document includes our first evaluation of benzocaine for this use.
Based on our evaluation of the available data and information, we have
tentatively concluded that the data are not sufficient to support the
safety and effectiveness of benzocaine for this use. This proposed
rule, if finalized, would require an approved new drug application
(NDA) or abbreviated new drug application (ANDA) for the marketing of
OTC weight control products containing benzocaine.

DATES: Submit written or electronic comments on the proposed rule by
June 7, 2011. See section IX of this document for information on the
proposed effective date of this proposed rule.

ADDRESSES: You may submit comments, identified by Docket No. FDA-1981-
N-0012 (formerly Docket No. 1981N-0022 and RIN No. 0910-AF45 by any of
the following methods:

Electronic Submissions

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

Written Submissions

    Submit written submissions in the following ways:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name
and Docket No. FDA-1981-N-0012 (formerly Docket No. 1981N-0022) and RIN
No. 0910-AF45 for this rulemaking. All comments received may be posted
without change to http://www.regulations.gov, including any personal
information provided.
    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: Michelle M. Jackson, Center for Drug
Evaluation and Research (HFD-560), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 22, MS 5411, Silver Spring, MD 20993-0002,
301-796-2090.

SUPPLEMENTARY INFORMATION:

I. Purpose of This Document

    In the Federal Register of February 26, 1982, we (FDA) published an
ANPR to establish a monograph for OTC weight control drug products. The
ANPR included the recommendations of an Advisory Review Panel on the
OTC Miscellaneous Internal Drug Products (the Panel) that evaluated all
OTC weight control drug products on the market at the time the OTC drug
review began in 1972. The Panel consisted of

scientists and health care providers from outside FDA. The Panel
concluded that ``benzocaine is safe for oral use as an OTC anorectic in
a dose of 3 to 15 milligrams (mg) in gum, lozenges, or candy'' and that
``benzocaine in the form of gum, lozenges, or candy is an effective OTC
drug product for weight control'' (47 FR 8466 at 8474). The Panel
believed that benzocaine numbed the oral cavity (including the taste
buds), thereby discouraging food consumption and decreasing caloric
intake.
    We reviewed the information and data available to the Panel as well
as information and data that has been developed since the Panel met to
help us determine whether benzocaine is GRASE when used in OTC weight
control drug products. Under the Federal Food, Drug, and Cosmetic Act
(the FD&C Act), all ``new drugs'' are required to obtain approval under
section 505 of the FD&C Act (21 U.S.C. 355) prior to marketing. Most
drugs are ``new drugs'' under the FD&C Act; however, a drug is excluded
from being a ``new drug'' (and therefore is not required to obtain
approval under section 505) if it is ``generally recognized, among
experts qualified by scientific training and experience to evaluate the
safety and effectiveness of drugs, as safe and effective for use under
the conditions prescribed, recommended, or suggested in the labeling
thereof.'' (21 U.S.C. 321(p)(1)).\1\
---------------------------------------------------------------------------

    \1\ Consistent with the principles explained previously, the OTC
drug review regulations in 21 CFR 330.10 specify the considerations
and evidence required to establish both safety and effectiveness.
---------------------------------------------------------------------------

    As explained in this document, we tentatively conclude that the
existing evidence is inadequate to establish that OTC weight control
drug products containing benzocaine are GRASE. Accordingly, we are
proposing to classify benzocaine as nonmonograph (i.e., not GRASE) for
use in OTC weight control drug products. If this proposed rule becomes
a final rule, OTC weight control drug products containing benzocaine
will require an approved NDA or ANDA. Studies that may help demonstrate
the safety and effectiveness of weight loss drug products are described
in an FDA guidance entitled ``Developing Products for Weight
Management'' (Ref. 1).

II. Rulemakings and Petitions for OTC Weight Control Drug Products

    The Panel responsible for evaluating OTC weight control drug
products recommended that benzocaine-containing drug products be deemed
GRASE for use in OTC weight control drug products. The Panel's
recommendations were published in the Federal Register as an ANPR for
OTC weight control products in 1982 (47 FR 8466).
    Following publication of the 1982 ANPR, Thompson Medical Co., a
manufacturer of OTC weight control drug products, submitted two citizen
petitions, one in 1990 and another in 1992, to support the
effectiveness of benzocaine for use as an appetite suppressant (Refs. 2
and 3). The 1990 petition (Ref. 2) included a clinical study by Collipp
(Refs. 4 and 5) and a summary of a clinical study by Piscano and
Lichter (Ref. 6) as data supporting the effectiveness of benzocaine as
an appetite suppressant. We responded to the manufacturer's 1990
petition (Ref. 7) reviewing the data submitted in the petition and
explaining our finding that the data did not provide substantial
evidence from adequate and well-controlled studies to support the
effectiveness of benzocaine for weight control use.
    The 1992 petition (Ref. 3) was submitted in response to our 1991
letter. The petition provided two unpublished statistical reevaluations
of the Collipp study, arguing that this data supported finding
benzocaine GRASE for use in OTC weight control drug products. We
responded to the petition in 1993 (Ref. 8), stating that the
reevaluations of the Collipp study did not substantiate the claim of
effectiveness of benzocaine for use in weight control. The two
reanalyses of the Collipp data include: (1) An analysis of covariance
excluding subjects that failed to meet either the age or the degree of
overweight inclusion criteria, and (2) a hierarchical regression model
to determine the effect of benzocaine after attempting to control for
any familial effects. Neither of these analyses adequately addressed
the three main problems that were listed in the 1991 response: (1)
Possible breaking of the blind; (2) imbalance in the sample for
important variables (age by family status); and (3) lack of
randomization within families, affecting the independence of
observations. These problems potentially biased the data affecting the
interpretability of the study results.
    Subsequent to our letter, we received draft protocols for
effectiveness studies (Ref. 9) from the same manufacturer, which were
intended to generate support for a GRASE finding. We sent
recommendations on the draft protocols in 1992 (Ref. 10), but have not
yet received any study results.

III. Efficacy Evaluation

    We are proposing that benzocaine be classified as nonmonograph at
any concentration for use in OTC weight control drug products. This
conclusion is based in part on our review of the effectiveness data
that was submitted to the Panel (Refs. 11 through 17) and additional
data submitted to us after publication of the 1982 ANPR, including the
two petitions and draft protocols described previously (Refs. 2, 3, and
9). In our responses to the petitions, we explained in detail why we
did not find the available data adequate to support a determination
that benzocaine is generally recognized as effective (GRAE) for this
use (Refs. 7, 8, and 10). In this document, we summarize the available
data and limitations that prevent us from finding benzocaine GRAE for
use in OTC weight control drug products. We have not received any
additional data from any company or citizen since our 1992 response
letter (Ref. 10) discussed previously; and we are not aware of any
safety or effectiveness studies for benzocaine in OTC weight control
drug products conducted since 1992.
    In the following sections, we will first describe the studies
reviewed by the Panel. After reviewing the data and findings from these
studies, we will explain why the Agency has concluded that these
studies do not support a finding that benzocaine is GRAE for use in OTC
weight control drug products.

A. Non-Clinical Studies

1. Review of Studies
    In the ANPR, we reported that the Panel considered a few
nonclinical studies (Refs. 11, 12, and 13) on benzocaine for weight
control. One of the factors involved in overeating and resulting
obesity is the need to satisfy the sense of taste. Horowitze (Ref. 11)
and Rosner (Ref. 12) showed that there appears to be a decreased
ability to detect degrees of sweetness by taste perception after
chewing gum containing benzocaine. Coons (Ref. 13) demonstrated the
effects of a local anesthetic on hunger reduction in rats. The Panel
considered this study to be an objective demonstration of the
effectiveness of a local anesthetic on hunger reduction.
2. Analysis of Studies
    We do not believe these studies support a GRAE determination
because they do not demonstrate that decreased taste perception or
decreased hunger results in weight loss. To find benzocaine GRAE based
in part on these types of studies, we would also need data
demonstrating what level of decrease in taste perception or hunger
actually resulted in a ``clinically

significant benefit of the type claimed'' (i.e., weight loss) as
required under Sec.  330.10(a)(4)(ii) (21 CFR 330.10(a)(4)(ii)).

B. Clinical Studies

1. Review of Studies
    The Panel also considered clinical studies that included weight
loss as an endpoint. Gould (Refs. 14 and 15) assessed various case
reports citing 1.5 to 2.0 pounds (lbs) per week weight loss using
lozenges containing benzocaine and essential oils in conjunction with
dietary restrictions. Plotz (Ref. 16) conducted an uncontrolled, non-
randomized 10-week study of 50 overweight adults (12 to 102 lbs
overweight). The subjects were instructed to chew one or two pieces of
gum for 5 or 10 minutes followed by a glass of water, just before
meals. If subjects became hungry between meals, they could chew gum
every few hours. The study results showed weight loss (2 pounds per
week) in 45 of 50 patients using the benzocaine gum in conjunction with
dietary restrictions.
    McClure and Brush (Ref. 17) conducted a placebo-controlled,
randomized, double-blinded 21-week study of 308 overweight adults (255
females and 53 males). The subjects were divided into five paired
treatment groups:
     Group 1: Dextroamphetamine sulfate (10 mg, daily)
     Group 2: OTC proprietary appetite suppressant (AYDS)
     Group 3: Dietary restriction (800 to 1,200 calories daily)
     Group 4: Glucose hard candy containing benzocaine,
caffeine, and vitamins (benzocaine group)
     Group 5: Glucose candy only (control group)
    Over the course of 4 weeks, 170 participants dropped out of the
study (37 participants from the dextroamphetamine group, 43
participants from the AYDS group, 51 participants from the dietary
restriction group, 9 participants from the benzocaine group, and 30
participants from the control group). The investigators reported an
average weight loss during the first 4 weeks of 4.6 lbs for the glucose
(control) group and 12.1 lbs for the benzocaine group. After 21 weeks,
the control group lost a weekly average of 0.60 lbs as compared to 2.20
lbs for the benzocaine group.
    In addition to these studies reviewed by the Panel, as described
previously, we also reviewed clinical studies submitted by a
manufacturer of OTC weight control drug products in two petitions. The
studies provided in the petitions included weight loss as an endpoint.
Reports purporting to be two studies by Collipp (one published and one
unpublished) were submitted. These reports appear to be the same study
(Refs. 4 and 5). The Collipp study was designed to be a 6-week, double-
blind, placebo-controlled, randomized trial comparing benzocaine (5 mg)
lozenges with placebo lozenges that were identical in appearance (Ref.
4). Male or female subjects who weighed 15 to 30 percent more than the
ideal weight for their body frame as determined from Metropolitan Life
Insurance Co. weight tables and were between 14 and 55 years of age
were eligible for enrollment. Subjects were recruited from the same
families. Subjects were instructed to follow a 1,250 calorie diet and
to take 1 to 2 lozenges 10 minutes before meals, 1 lozenge instead of
dessert, and 1 or 2 lozenges between meals. Subjects were also
instructed to drink a glass of water, tea, coffee, or other non-caloric
beverage with each lozenge ingestion. Body weight was measured at week
0 and biweekly for the next 6 weeks. Subjects were also asked to rate
the average quality of between-meal appetite suppression as mild,
moderate, or complete.
    The study results showed that the mean body weight decreased from
week 0 in both the active treatment and placebo groups. Subjects
treated with benzocaine had a mean weight loss that was statistically
significant (p <=: 0.001) at all time points. The mean weight loss
during the study was approximately twice as great for subjects treated
with benzocaine (-3.5, -4.9, and -6.0 at 2, 4, and 6 weeks,
respectively) compared to placebo (-2.1, -2.9, and -2.7 at 2, 4, and 6
weeks, respectively). The manufacturer also submitted a study by
Piscano and Lichter (Ref. 6) which consisted of a 1-page summary
describing an 8-week uncontrolled trial involving 26 children. The
summary listed the baseline weight, final weight, and weight loss of
each subject. The summary results showed that the subjects lost
approximately 0.5 lbs/week. There was no protocol description and no
statistical analysis.
2. Analysis of Studies
    We found a lack of substantial evidence consisting of adequate and
well-controlled studies, as required in Sec.  330.10(a)(4)(ii), on
which to base a determination of the effectiveness of benzocaine in OTC
weight control drug products. In general, the clinical studies reviewed
by the Panel (Refs. 14 through 17) are inadequately controlled, and
study results were not clinically and statistically significant. For
example, among other limitations, the Gould studies (Refs. 14 and 15)
were not well-controlled, as these studies consisted of case reports.
Similarly, the Plotz study (Ref. 16) was not well controlled, being
both uncontrolled and non-randomized. Finally, as detailed in our 1993
response (Ref. 8), the McClure and Brusch study (Ref. 17) had
significant methodological flaws including potential issues with
subject recruitment, inconsistent follow up of subjects and inadequate
assessment of baseline characteristics.
    The materials submitted in the petition were also insufficient to
establish the effectiveness of benzocaine in OTC weight control
products. For example, the Pisano and Lichter (Ref. 6) study was not
adequate and well-controlled as it consisted of case reports, did not
include a protocol description and did not provide a statistical
analysis. Similarly, the Collipp study and the reevaluations of the
study submitted in the petitions do not provide detail regarding study
design and outcomes sufficient to show benzocaine is GRASE for use in
weight control. Specifically, the Collipp study had a significant
number of limitations that prevent us from concluding that benzocaine
is GRAE for weight control:
     Non-random selection of subjects
     Possible breaking of blinding
     Analysis did not account for a lack of independence among
subjects within the same family, potentially affecting the study's
findings
    It is important to note that after providing the petitioning
manufacturer with a response describing these limitations, we received
a protocol for a further study from the manufacturer (Ref. 9). We
provided feedback on the protocol in 1992 (Ref. 10), but we have not
yet received the study results from the manufacturer. In order to
establish effectiveness, additional data are still needed to show that
benzocaine causes a clinically and statistically significant weight
loss when compared with placebo. The industry is advised to consult a
recently published FDA guidance on the development of products for
weight management about the requirement of clinical data (Ref. 1).

IV. Safety Evaluation

    We are not aware of adequate data to demonstrate that OTC weight
control drug products containing benzocaine are generally recognized as
safe (GRAS) as defined under Sec.  330.10(a)(4)(ii). Under this
regulatory provision, support for a GRAS showing ``shall consist of
adequate tests by methods reasonably applicable to show the drug is
safe under the prescribed, recommended, or suggested conditions of
use.'' We believe

that the safety of the Panel's proposed benzocaine dosing for OTC
weight control use (multiple 3 to 15 mg doses for up to 3 months) has
not been adequately established. Additional safety data is needed to
establish dosage limitations or other aspects of the labeling. Our
current recommendation as to what would constitute adequate testing for
a weight control drug product is described in our guidance on weight
control drug products (Ref. 1).

V. Analysis of Impacts

    We have examined the impacts of this 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). We believe that this
proposed rule is not a significant regulatory action as defined by 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 few products will likely be affected and
those effects would probably be small, we do not believe that this
proposed rule would 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 $135 million, using the most current (2009) Implicit
Price Deflator for the Gross Domestic Product. We do not expect this
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
    If this proposed rule is finalized, OTC marketing of weight control
drug products containing benzocaine for this use will cease, unless a
product is approved under an NDA or ANDA. In this proposed rule, we
tentatively conclude that OTC weight control drug products containing
benzocaine lack sufficient evidence to support a finding that such
products are GRASE, and that finalization of the regulatory status of
this ingredient will benefit consumers by removing from the marketplace
products that have not been shown to be safe and effective. We do not
expect this rule to have a significant effect on industry as a whole,
as we have only been able to identify one company that manufactures a
benzocaine-containing OTC weight control drug product.
    We have few alternatives available to us when we determine there
are no data available to demonstrate that an active ingredient is
GRASE. Even without evidence of harm caused by the use of these
products, they cannot remain on the market because there is no evidence
that they are safe and effective. Accordingly, we have proposed a 30-
day period within which companies may remove benzocaine-containing
weight control drug products from the market. We believe the only
alternative to this approach is a longer implementation period.\2\ We
could allow a longer implementation period so manufacturers would have
time to submit additional effectiveness and safety data, but if we took
this approach, consumers would be unnecessarily exposed to products
that have not been shown to be effective or safe.
---------------------------------------------------------------------------

    \2\ See 5 U.S.C. 553(d).
---------------------------------------------------------------------------

VI. Paperwork Reduction Act of 1995

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

VII. Environmental Impact

    We have determined under 21 CFR 25.31(a) 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. Federalism

    We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. Section 4(a) of the
Executive order requires agencies to ``construe * * * a Federal statute
to preempt State law only where the statute contains an express
preemption provision or there is some other clear evidence that the
Congress intended preemption of State law, or where the exercise of
State authority conflicts with the exercise of Federal authority under
the Federal statute.'' The sole statutory provision giving preemptive
effect to the proposed rule is section 751 of the act (21 U.S.C. 379r).
    We believe that the preemptive effect of this proposed rule, if
finalized, would be consistent with Executive Order 13132. Through the
publication of this proposed rule, we are providing notice and an
opportunity for State and local officials to comment on this
rulemaking.

IX. Proposed Effective Date

    Due to effectiveness concerns discussed in this document, any final
rule based on this proposal would become effective 30 days after the
date of its publication. Manufacturers are urged to comply voluntarily
with this proposed rule and to cease OTC marketing at the earliest
possible date.

X. References

    The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) under Docket No. FDA-
1981-N-0012 (formerly 1981N-0022) and may be seen by interested persons
between 9 a.m. and 4 p.m., Monday through Friday. (FDA has verified the
Web site address, but we are not responsible for any subsequent changes
to the Web site after this document publishes in the Federal Register.)

1. FDA, ``Draft Guidance for Industry--Developing Products for
Weight Management,'' February 2007, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm071612.pdf, accessed on August 27, 2010.
2. Comment No. CP12, Docket No. FDA-1981-N-0012 (formerly 1981N-
0022), Division of Dockets Management System.
3. Comment No. CP15, Docket No. FDA-1981-N-0012 (formerly 1981N-
0022), Division of Dockets Management System.
4. Collipp, P. J., ``The Treatment of Exogenous Obesity by Medicated
Benzocaine Candy: A Double-Blind Placebo-Controlled Study,'' in OTC
Vol. 170010, Docket No. FDA-1981-N-0012 (formerly 1981N-0022),
Division of Dockets Management.
5. Collipp, P. J., ``The Treatment of Exogenous Obesity by Medicated
Benzocaine Candy: A Double Blind Placebo Study,'' Obesity/Bariatric
Medicine, 10:123-125, 1981.
6. Piscano, J. and H. Lichter, ``A Matter of Taste,'' Fredrick Fell
Publishers, Inc., New York, New York, pp. 42-64, 1979.
7. Comment No. LET82, Docket No. FDA-1981-N-0012 (formerly 1981N-
0022), Division of Dockets Management System.
8. Comment No. LET87, Docket No. FDA-1981-N-0012 (formerly 1981N-
0022), Division of Dockets Management System.
9. Comment No. PR9, Docket No. FDA-1981-N-0012 (formerly 1981N-
0022), Division of Dockets Management System.
10. Comment No. LET84, Docket No. FDA-1981-N-0012 (formerly 1981N-
0022), Division of Dockets Management System.

11. Horowitz, S. and R. P. Scalici, ``Results of Sensory Panel Tests
on Slim-Mint Chewing Gum,'' in OTC Vol. 170010, Docket No. FDA-1981-
N-0012 (formerly 1981N-0022), Division of Dockets Management.
12. Rosner, L., ``To Determine the Effect of Chewing Slim-Mint Gum
Upon Taste Perception, Particularly Toward Sweetness,'' in OTC Vol.
170010, Docket No. FDA-1981-N-0012 (formerly 1981N-0022), Division
of Dockets Management.
13. Summary Minutes of the 11th meeting of the Advisory Review Panel
on OTC Miscellaneous Internal Drug Products held on May 9-10, 1976
in OTC Vol. 170010, Docket No. FDA-1981-N-0012 (formerly 1981N-
0022), Division of Dockets Management.
14. Gould, W. L., ``On the Use of a Medicament to Reduce the
Appetite in the Treatment of Obesity and Other Conditions,'' New
York State Journal of Medicine, 47:981-983, 1947.
15. Gould, W. L., ``Obesity and Hypertension: The Importance of a
Safe Compound to Control Appetite,'' North Carolina Medical Journal,
11:327-334, 1950.
16. Plotz, M., ``Obesity,'' Medical Times, 86:860-863, 1958.
17. McClure, C. W. and C. A. Brusch, ``Treatment of Oral Syndrome
Obesity with Non traditional Appetite Control Plan,'' Journal of the
American Women's Medical Association, 28:239-248, 1973.

List of Subjects in 21 CFR Part 310

    Administrative practice and procedure, Drugs, Labeling, Medical
devices, 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 310 be amended as follows:

PART 310--NEW DRUGS

    1. The authority citation for 21 CFR part 310 continues to read as
follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 355, 360b-360f,
360j, 361(a), 371, 374, 375, 379e; 42 U.S.C. 216, 241, 242(a), 262,
263b-263n.
    2. Section 310.545 is amended by adding paragraphs (a)(20)(i),
(a)(20)(ii), and (a)(20)(iii); by revising paragraph (d) introductory
text; and by adding paragraph (d)(40) to read as follows:

Sec.  310.545  Drug products containing certain active ingredients
offered over-the-counter (OTC) for certain uses.

    (a) * * *
    (20) * * *
    (i) [Reserved]
    (ii) [Reserved]
    (iii) Approved as of [DATE 30 DAYS AFTER DATE OF PUBLICATION OF THE
FINAL RULE IN THE FEDERAL REGISTER].
    Benzocaine
* * * * *
    (d) Any OTC drug product that is not in compliance with this
section is subject to regulatory action if initially introduced or
initially delivered for introduction into interstate commerce after the
dates specified in paragraphs (d)(1) through (d)(40) of this section.
* * * * *
    (40) [DATE 30 DAYS AFTER DATE OF PUBLICATION OF THE FINAL RULE IN
THE FEDERAL REGISTER], for products subject to paragraph (a)(20)(iii)
of this section.

    Dated: March 2, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-5145 Filed 3-8-11; 8:45 am]
BILLING CODE 4160-01-P