[Federal Register: October 26, 2007 (Volume 72, Number 207)]
[Notices]
[Page 60840-60841]
[DOCID:fr26oc07-58]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12843-000]

FFP Project 23, LLC; Notice of Application Accepted for Filing
and Soliciting Motions To Intervene, Protests, and Comments

October 18, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Type of Application: Preliminary Permit.
    b. Project No.: 12843-000.
    c. Date filed: July 25, 2007.
    d. Applicant: FFP Project 23, LLC.
    e. Name of Project: White Alder Project.
    f. Location: The project would be located on the Mississippi River
in St. Gabriel and Iberville Parishes, Louisiana. The project uses no
dam or impoundment.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Dan Irvin, FFP Project 23, LLC, 69 Bridge
Street, Manchester, MA 01944, phone<PHONE_NUMBER>.
    i. FERC Contact: Robert Bell,<PHONE_NUMBER>.
    j. Deadline for filing comments, protests, and motions to
intervene: 60 days from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426. Comments, protests, and
interventions may be filed electronically via the Internet in lieu of
paper; see 18 CFR 385.2001(a)(1)(iii) and the instructions on the
Commission's Web site under the ``e-Filing'' link. The Commission
strongly encourages electronic filings. Please include the project
number (P-12843-000) on any comments or motions filed.
    The Commission's Rules of Practice and Procedure require all
intervenors filing documents with the Commission to serve a copy of
that document on each person in the official service list for the
project. Further, if an intervenor files comments or documents with the
Commission relating to the merits of an issue that may affect the
responsibilities of a particular resource agency, they must also serve
a copy of the document on that resource agency.
    k. Description of Project: The proposed project consists of: (1)
2,550

proposed 20 kilowatt Free Flow generating units having a total
installed capacity of 51 megawatts, (2) a proposed transmission line;
and (3) appurtenant facilities. The FFP Project 23, LLC, project would
have an average annual generation of 223.38 gigawatt-hours and be sold
to a local utility.
    l. Locations of Applications: A copy of the application is
available for inspection and reproduction at the Commission in the
Public Reference Room, located at 888 First Street, NE., Room 2A,
Washington DC 20426, or by calling<PHONE_NUMBER>. This filing may also
be viewed on the Commission's Web site at http://www.ferc.gov using the

``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3676 or e-mail
<EMAIL_ADDRESS>For TTY, call<PHONE_NUMBER>. A copy is

also available for inspection and reproduction at the address in item h
above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Competing Preliminary Permit: Anyone desiring to file a
competing application for preliminary permit for a proposed project
must submit the competing application itself, or a notice of intent to
file such an application, to the Commission on or before the specified
comment date for the particular application (see 18 CFR 4.36).
Submission of a timely notice of intent allows an interested person to
file the competing preliminary permit application no later than 30 days
after the specified comment date for the particular application. A
competing preliminary permit application must conform with 18 CFR 4.30
and 4.36.
    o. Competing Development Application: Any qualified development
applicant desiring to file a competing development application must
submit to the Commission, on or before a specified comment date for the
particular application, either a competing development application or a
notice of intent to file such an application. Submission of a timely
notice of intent to file a development application allows an interested
person to file the competing application no later than 120 days after
the specified comment date for the particular application. A competing
license application must conform with 18 CFR 4.30 and 4.36.
    p. Notice of Intent: A notice of intent must specify the exact
name, business address, and telephone number of the prospective
applicant, and must include an unequivocal statement of intent to
submit, if such an application may be filed, either a preliminary
permit application or a development application (specify which type of
application). A notice of intent must be served on the applicant(s)
named in this public notice.
    q. Proposed Scope of Studies Under Permit: A preliminary permit, if
issued, does not authorize construction. The term of the proposed
preliminary permit would be 36 months. The work proposed under the
preliminary permit would include economic analysis, preparation of
preliminary engineering plans, and a study of environmental impacts.
Based on the results of these studies, the Applicant would decide
whether to proceed with the preparation of a development application to
construct and operate the project.
    r. Comments, Protests, or Motions To Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    Comments, protests and interventions may be filed electronically
via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and
the instructions on the Commission's Web site under ``e-filing'' link.
The Commission strongly encourages electronic filing.
    s. Filing and Service of Responsive Documents: Any filings must
bear in all capital letters the title ``COMMENTS'', ``COMPETING
APPLICATION'', ``RECOMMENDATIONS FOR TERMS AND CONDITIONS'',
``PROTEST'', OR ``MOTION TO INTERVENE'', as applicable, and the Project
Number of the particular application to which the filing refers. Any of
the above-named documents must be filed by providing the original and
the number of copies provided by the Commission's regulations to: The
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426. A copy of any motion to intervene must also be
served upon each representative of the Applicant specified in the
particular application.
    t. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-21157 Filed 10-25-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 85, Number 147 (Thursday, July 30, 2020)]
[Rules and Regulations]
[Pages 45776-45779]
[FR Doc No: 2020-16485]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2020-0588; Product Identifier 2020-NM-048-AD; Amendment
39-21173; AD 2020-15-10]
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
certain Airbus SAS Model A350-941 airplanes. This AD was prompted by
reports of improperly locked diagonal struts located in a certain
section of the fuselage; the teeth of the lock washers were incorrectly
engaged, which could lead to a loss of tightening torque of an affected
strut. This AD requires inspecting the diagonal strut for correct
installation and for correct locking of the lock washers, and
corrective actions if necessary, 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 August 14, 2020.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of August 14,
2020.
    The FAA must receive comments on this AD by September 14, 2020.

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: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE, Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.
    For the material identified in this AD that is incorporated by
reference (IBR), contact the EASA, Konrad-Adenauer-Ufer 3, 50668
Cologne, Germany; telephone +49 221 89990 1000; email
<EMAIL_ADDRESS>internet www.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-2020-
0588.

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-2020-
0588; 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. Comments will be
available in the AD docket shortly after receipt.

FOR FURTHER INFORMATION CONTACT: Kathleen Arrigotti, Aerospace
Engineer, Large Aircraft Section, International Validation Branch, FAA,
2200 South 216th St., Des Moines, WA 98198; telephone and fax 206-231-
3218; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    The EASA, which is the Technical Agent for the Member States of the
European Union, has issued EASA AD 2020-0071, dated March 25, 2020
(``EASA AD 2020-0071'') (also referred to as the Mandatory Continuing
Airworthiness Information, or ``the MCAI''), to correct an unsafe
condition for certain Airbus SAS Model A350-941 airplanes.
    This AD was prompted by reports of improperly locked diagonal
struts located in a certain section of the fuselage; the teeth of the
lock washers were incorrectly engaged, which could lead to a loss of
tightening torque of an affected strut. The FAA is issuing this AD to
address this condition, which could affect the structural integrity of
the surrounding parts, possibly resulting in failure of the horizontal
tail plane attachments or rear cone joints, and consequent reduction or
loss of control of the airplane. See the MCAI for additional background
information.

Related IBR Material Under 1 CFR Part 51

    EASA AD 2020-0071 describes procedures for inspecting the diagonal
strut for correct installation and for correct locking of the lock
washers, and corrective actions if necessary. The corrective actions
include a general visual inspection of the affected strut for damage,
repair of damaged struts, and re-installation of affected struts with
no damage.
    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 our 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
2020-0071 described previously, as incorporated by reference, except
for any differences identified as exceptions in the regulatory text of
this AD.

Explanation of Required Compliance Information

    In the FAA's ongoing efforts to improve the efficiency of the AD
process, the FAA initially worked with Airbus and EASA to develop a
process to use certain EASA ADs as the primary source of information
for compliance with requirements for corresponding FAA ADs. The FAA has
since coordinated with other manufacturers and civil aviation
authorities (CAAs) to use this process. As a result, EASA AD 2020-0071
is incorporated by reference in this final rule. This AD, therefore,
requires compliance with EASA AD 2020-0071 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 the

EASA AD 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 the EASA AD. Service information specified in EASA AD
2020-0071 that is required for compliance with EASA AD 2020-0071 is
available on the internet at https://www.regulations.gov by searching
for and locating Docket No. FAA-2020-0588.

FAA's Justification and Determination of the Effective Date

    Since there are currently no domestic operators of these products,
notice and opportunity for public comment before issuing this AD are
unnecessary. In addition, for the reasons stated above, the FAA finds
that good cause exists for making this amendment effective in less than
30 days.

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and the FAA did not precede it by notice and opportunity for
public comment. The FAA invites you to send any written relevant data,
views, or arguments about this AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2020-0588;
Product Identifier 2020-NM-048-AD'' at the beginning of your comments.
The most helpful comments reference a specific portion of the proposal,
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 AD based on 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 the FAA receives, without change,
to https://www.regulations.gov, including any personal information you
provide. The FAA will also post a report summarizing each substantive
verbal contact the FAA receives about this AD.

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 final rule, request for
comments, 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 final rule, request for
comments, 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 final rule, request for comments. Submissions containing
CBI should be sent to the person identified in the FOR FURTHER
INFORMATION CONTACT section. Any commentary that the FAA receives which
is not specifically designated as CBI will be placed in the public
docket for this rulemaking.

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

    Currently, there are no affected U.S.-registered airplanes. If an
affected airplane is imported and placed on the U.S. Register in the
future, the FAA provides the following cost estimates to comply with
this AD:

                 Estimated Costs for Required Actions *
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
3 work-hours x $85 per hour = $340....              $0             $255
------------------------------------------------------------------------
* Table does not include estimated costs for reporting.

    The FAA estimates that it would take about 1 work-hour per product
to comply with the reporting requirement in this AD. The average labor
rate is $85 per hour. Based on these figures, the FAA estimates the
cost of reporting the inspection results on U.S. operators to be $85
per product.

                Estimated Costs of On-Condition Actions *
------------------------------------------------------------------------
                                                             Cost per
              Labor cost                   Parts cost        product
------------------------------------------------------------------------
2 work-hours x $85 per hour = $170....              $0             $170
------------------------------------------------------------------------
* Table does not include estimated costs for the on-condition repair of
  damaged struts. The FAA has received no definitive data that would
  enable us to provide cost estimates for that action.

Paperwork Reduction Act

    A federal agency may not conduct or sponsor, and a person is not
required to respond to, nor shall a person be subject to penalty for
failure to comply with a collection of information subject to the
requirements of the Paperwork Reduction Act unless that collection of
information displays a current valid OMB control number. The control
number for the collection of information required by this AD is 2120-
0056. The paperwork cost associated with this AD has been detailed in
the Costs of Compliance section of this document and includes time for
reviewing instructions, as well as completing and reviewing the
collection of information. Therefore, all reporting associated with
this AD is mandatory. Comments concerning the accuracy of this burden
and suggestions for reducing the burden should be directed to
Information Collection Clearance Officer, Federal Aviation
Administration, 10101 Hillwood Parkway, Fort Worth, TX 76177-1524.

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 (AD):

2020-15-10 Airbus SAS: Amendment 39-21173; Docket No. FAA-2020-0588;
Product Identifier 2020-NM-048-AD.

(a) Effective Date

    This AD becomes effective August 14, 2020.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies Airbus SAS Model A350-941 airplanes,
certificated in any category, as identified in European Union
Aviation Safety Agency (EASA) AD 2020-0071, dated March 25, 2020
(``EASA AD 2020-0071'').

(d) Subject

    Air Transport Association (ATA) of America Code 53, Fuselage.

(e) Reason

    This AD was prompted by reports of improperly locked diagonal
struts located in a certain section of the fuselage; the teeth of
the lock washers were incorrectly engaged, which could lead to a
loss of tightening torque of an affected strut. The FAA is issuing
this AD to address this condition, which could affect the structural
integrity of the surrounding parts, possibly resulting in failure of
the horizontal tail plane attachments or rear cone joints, and
consequent reduction or loss of 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, EASA AD 2020-0071.

(h) Exceptions to EASA AD 2020-0071

    (1) The ``Remarks'' section of EASA AD 2020-0071 does not apply
to this AD.
    (2) Paragraph (3) of EASA AD 2020-0071 specifies to report
inspection results to Airbus within a certain compliance time. For
this AD, report inspection results at the applicable time specified
in paragraph (h)(2)(i) or (ii) of this AD.
    (i) If the inspection was done on or after the effective date of
this AD: Submit the report within 30 days after the inspection.
    (ii) If the inspection was done before the effective date of
this AD: Submit the report within 30 days after the effective date
of this AD.

(i) 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 local Flight
Standards District 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 (j) 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 local flight standards district office/
certificate holding district 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): For any service information
referenced in EASA AD 2020-0071 that contains RC procedures and
tests: Except as required by paragraph (i)(2) of this AD, RC
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.
    (4) Paperwork Reduction Act Burden Statement: A federal agency
may not conduct or sponsor, and a person is not required to respond
to, nor shall a person be subject to a penalty for failure to comply
with a collection of information subject to the requirements of the
Paperwork Reduction Act unless that collection of information
displays a current valid OMB Control Number. The OMB Control Number
for this information collection is 2120-0056. Public reporting for
this collection of information is estimated to be approximately 1
hour per response, including the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing the collection of information.
All responses to this collection of information are mandatory as
required by this AD; the nature and extent of confidentiality to be
provided, if any. Send comments regarding this burden estimate or
any other aspect of this collection of information, including
suggestions for reducing this burden to Information Collection
Clearance Officer, Federal Aviation Administration, 10101 Hillwood
Parkway, Fort Worth, TX 76177-1524.

(j) Related Information

    For more information about this AD, contact Kathleen Arrigotti,
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>
(k) 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 2020-0071,
dated March 25, 2020.
    (ii) [Reserved]
    (3) For information about EASA AD 2020-0071, contact the EASA,
Konrad-Adenauer-Ufer 3, 50668 Cologne, Germany; telephone +49 221
89990 6017; 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-2020-0588.
    (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 July 13, 2020.
Lance T. Gant,
Director, Compliance & Airworthiness Division, Aircraft Certification
Service.
[FR Doc. 2020-16485 Filed 7-29-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 250 (Thursday, December 29, 2011)]
[Notices]
[Pages 82022-82024]
[FR Doc No: 2011-33447]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66033; File No. SR-FINRA-2011-074]

Self-Regulatory Organizations; Financial Industry Regulatory
Authority, Inc.; Notice of Filing and Immediate Effectiveness of
Proposed Rule Change Extending the Pilot Period Regarding the Use of
Multiple MPIDs on FINRA Facilities

December 22, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby
given that on December 21, 2011, Financial Industry Regulatory
Authority, Inc. (``FINRA'') filed with the Securities and Exchange
Commission (``SEC'' or ``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
FINRA. FINRA has designated the proposed rule change as constituting a
``non-controversial'' rule change under paragraph (f)(6) of Rule 19b-4
under the Exchange Act,\3\ which renders the proposal effective upon
receipt of this filing by the Commission. The Commission is publishing
this notice to

solicit comments on the proposed rule change from interested persons.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    FINRA is proposing to extend through January 25, 2013, the current
rules regarding the use of multiple Market Participant Symbols
(``MPIDs'') in FINRA Rules 6160 (with respect to Trade Reporting
Facilities (``TRFs'')), 6170 (with respect to the Alternative Display
Facility (``ADF'')), and 6480 (with respect to the OTC Reporting
Facility (``ORF'')).
    The text of the proposed rule change is available on FINRA's Web
site at http://www.finra.org, at the principal office of FINRA, at the
Commission's Public Reference Room.

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

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

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

1. Purpose
    FINRA has three rules governing the use of multiple MPIDs on FINRA
facilities: Rule 6160 (Multiple MPIDs for Trade Reporting Facility
Participants), Rule 6170 (Primary and Additional MPIDs for Alternative
Display Facility Participants), and Rule 6480 (Multiple MPIDs for
Quoting and Trading in OTC Equity Securities). The pilot period for all
three rules is scheduled to expire on January 27, 2012. FINRA believes
that there continue to be legitimate business reasons for members to
maintain multiple MPIDs for use on FINRA facilities. Consequently,
FINRA is proposing to extend the pilot period for each of the three
rules until January 25, 2013. FINRA is not proposing any other changes
to the rules at this time; however, FINRA notes that it intends to file
a proposed rule change within the next year that amends the rules
governing multiple MPIDs, including a proposed rule change to make the
rules permanent.
(1) Rule 6160
    Rule 6160 provides that any Trade Reporting Facility Participant
that wishes to use more than one MPID for purposes of reporting trades
to a TRF must submit a written request to, and obtain approval from,
FINRA Operations for such additional MPIDs. In addition, Supplementary
Material to the rule states that FINRA considers the issuance of, and
trade reporting with, multiple MPIDs to be a privilege and not a right.
A Trade Reporting Facility Participant must identify the purpose(s) and
system(s) for which the multiple MPIDs will be used. If FINRA
determines that the use of multiple MPIDs is detrimental to the
marketplace, or that a Trade Reporting Facility Participant is using
one or more additional MPIDs improperly or for other than the
purpose(s) identified by the Participant, FINRA staff retains full
discretion to limit or withdraw its grant of the additional MPID(s) to
such Trade Reporting Facility Participant for purposes of reporting
trades to a TRF. FINRA believes that Rule 6160 is necessary to
consolidate the process of issuing, and tracking the use of, multiple
MPIDs used to report trades to TRFs.
    Rule 6160 was approved by the Commission in 2006 on a pilot
basis.\4\ The pilot period has been extended several times since the
rule was originally adopted and currently expires on January 27,
2012.\5\
---------------------------------------------------------------------------

    \4\ See Securities Exchange Act Release No. 54715 (November 6,
2006), 71 FR 66354 (November 14, 2006); see also Securities Exchange
Act Release No. 54715A (November 14, 2006), 71 FR 67183 (November
20, 2006).
    \5\ See Securities Exchange Act Release No. 63729 (January 18,
2011), 76 FR 4403 (January 25, 2011); Securities Exchange Act
Release No. 61297 (January 6, 2010), 75 FR 2173 (January 14, 2010);
Securities Exchange Act Release No. 59183 (December 30, 2008), 74 FR
842 (January 8, 2009); Securities Exchange Act Release No. 57217
(January 28, 2008), 73 FR 6234 (February 1, 2008); Securities
Exchange Act Release No. 55206 (January 31, 2007), 72 FR 5479
(February 6, 2007).
---------------------------------------------------------------------------

(2) Rule 6170
    Rule 6170 provides that a Registered Reporting ADF ECN may request
additional MPIDs for displaying quotes and orders and reporting trades
through the ADF trade reporting facility, TRACS, for any ADF-Eligible
Security. Among other things, Registered Reporting ADF ECNs are
prohibited from using an additional MPID to accomplish indirectly what
they are prohibited from doing directly through their Primary MPID. In
addition, FINRA staff retains full discretion to determine whether a
bona fide regulatory and/or business need exists for being granted an
additional MPID privilege and to limit or withdraw the additional MPID
display privilege at any time. The procedures for requesting, and the
restrictions surrounding the use of, multiple MPIDs are set forth in
Supplementary Material to the rule.
    The Commission approved Rule 6170 on a pilot basis on August 11,
2006.\6\ The pilot period has been extended several times since the
rule was originally adopted and currently expires on January 27,
2012.\7\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 54307 (August 11,
2006), 71 FR 47551 (August 17, 2006). By its terms, the initial
pilot period expired on January 26, 2007, to coincide with the
expiration of the ADF pilot period. See Securities Exchange Act
Release No. 53699 (April 21, 2006), 71 FR 25271 (April 28, 2006). On
January 26, 2007, the Commission approved a proposed rule change to
make the ADF rules permanent. See Securities Exchange Act Release
No. 55181 (January 26, 2007), 72 FR 5093 (February 2, 2007).
    \7\ See Securities Exchange Act Release No. 63729 (January 18,
2011), 76 FR 4403 (January 25, 2011); Securities Exchange Act
Release No. 61297 (January 6, 2010), 75 FR 2173 (January 14, 2010);
Securities Exchange Act Release No. 59183 (December 30, 2008), 74 FR
842 (January 8, 2009); Securities Exchange Act Release No. 57217
(January 28, 2008), 73 FR 6234 (February 1, 2008); Securities
Exchange Act Release No. 55206 (January 31, 2007), 72 FR 5479
(February 6, 2007).
---------------------------------------------------------------------------

(3) Rule 6480
    Like Rule 6160, Rule 6480 provides that any member that wishes to
use more than one MPID for purposes of quoting an OTC Equity Security
or reporting trades to the ORF must submit a written request to, and
obtain approval from, FINRA Operations for such additional MPIDs. The
rule also states that a member that posts a quotation in an OTC Equity
Security and reports to a FINRA system a trade resulting from such
posted quotation must utilize the same MPID for reporting purposes. In
addition, Supplementary Material to the rule states that FINRA
considers the issuance of, and trade reporting with, multiple MPIDs to
be a privilege and not a right. When requesting an additional MPID(s),
a member must identify the purpose(s) and system(s) for which the
multiple MPIDs will be used. If FINRA determines that the use of
multiple MPIDs is detrimental to the marketplace, or that a member is
using one or more additional MPIDs improperly or for purposes other
than the purpose(s) identified by the member, FINRA staff retains full
discretion to limit or withdraw its grant of the additional MPID(s) to
such member.

    FINRA adopted Rule 6480 on a pilot basis on July 23, 2009.\8\ The
pilot period currently expires on January 27, 2012.\9\
---------------------------------------------------------------------------

    \8\ See Securities Exchange Act Release No. 60414 (July 31,
2009), 74 FR 39721 (August 7, 2009).
    \9\ See Securities Exchange Act Release No. 63729 (January 18,
2011), 76 FR 4403 (January 25, 2011); see also Securities Exchange
Act Release No. 61297 (January 6, 2010), 75 FR 2173 (January 14,
2010).
---------------------------------------------------------------------------

    FINRA has filed the proposed rule change for immediate
effectiveness. The implementation date of the proposed rule change will
be January 27, 2012.
2. Statutory Basis
    FINRA believes that the proposed rule change is consistent with the
provisions of Section 15A(b)(6) of the Act,\10\ which requires, among
other things, that FINRA rules must be designed to prevent fraudulent
and manipulative acts and practices, to promote just and equitable
principles of trade, and, in general, to protect investors and the
public interest. FINRA believes that the proposed rule change is
consistent with these requirements because it will continue to provide
a process by which members can request, and FINRA can properly
allocate, the use of additional MPIDs for displaying quotes and orders
through the ADF or reporting trades to a TRF or the ORF.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78o-3(b)(6).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    FINRA does not believe that the proposed rule change will result in
any burden on competition that is not necessary or appropriate in
furtherance of the purposes of the Exchange Act.

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

    Written comments were neither solicited nor received.

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

    Because the foregoing proposed rule change does not:
    (i) Significantly affect the protection of investors or the public
interest;
    (ii) Impose any significant burden on competition; and
    (iii) become operative for 30 days from the date on which it was
filed, or such shorter time as the Commission may designate, if
consistent with the protection of investors and the public interest, it
has become effective pursuant to Section 19(b)(3)(A) of the Act \11\
and Rule 19b-4(f)(6) thereunder.\12\
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78s(b)(3)(A).
    \12\ 17 CFR 240.19b-4(f)(6). In addition, Rule 19b-4(f)(6)(iii)
requires the self-regulatory organization to submit to the
Commission written notice of its intent to file the proposed rule
change, along with a brief description and text of the proposed rule
change, at least five business days prior to the date of filing of
the proposed rule change, or such shorter time as designated by the
Commission. FINRA has satisfied this requirement.
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act. If the Commission
takes such action, the Commission shall institute proceedings to
determine whether the proposed rule should be approved or disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-FINRA-2011-074 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-FINRA-2011-074. This
file number should be included on the subject line if email is used. To
help the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of 10
a.m. and 3 p.m. Copies of such filing also will be available for
inspection and copying at the principal office of FINRA. All comments
received will be posted without change; the Commission does not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly. All
submissions should refer to File Number SR-FINRA-2011-074 and should be
submitted on or before January 19, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\13\
---------------------------------------------------------------------------

    \13\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2011-33447 Filed 12-28-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Pages 13685-13686]
[FR Doc No: 2013-04646]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-0162]

Determination of Regulatory Review Period for Purposes of Patent
Extension; LAVIV

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for LAVIV and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of an application to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions along with three copies and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 6284, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human biological product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human biologic product
LAVIV (azficel-T). LAVIV is an autologous cellular product indicated
for improvement of moderate to severe

nasolabial fold wrinkles in adults. Subsequent to this approval, the
Patent and Trademark Office received a patent term restoration
application for LAVIV (U.S. Patent No. 5,591,444) from Fibrocell
Technologies, Inc., and the Patent and Trademark Office requested FDA's
assistance in determining this patent's eligibility for patent term
restoration. In a letter dated August 10, 2012, FDA advised the Patent
and Trademark Office that this human biological product had undergone a
regulatory review period and that the approval of LAVIV represented the
first permitted commercial marketing or use of the product. Thereafter,
the Patent and Trademark Office requested that FDA determine the
product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
LAVIV is 3,338 days. Of this time, 2,500 days occurred during the
testing phase of the regulatory review period, while 838 days occurred
during the approval phase. These periods of time were derived from the
following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: May 3,
2002. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on May 3,
2002.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): March 6, 2009. FDA has verified the
applicant's claim that the biologics license application (BLA) for
LAVIV (BLA 125348) was initially submitted on March 6, 2009.
    3. The date the application was approved: June 21, 2011. FDA has
verified the applicant's claim that BLA 125348 was approved on June 21,
2011.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the U.S.
Patent and Trademark Office applies several statutory limitations in
its calculations of the actual period for patent extension. In its
application for patent extension, this applicant seeks 5 years of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by April 29, 2013. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by August 27, 2013. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written petitions.
It is only necessary to send one set of comments. However, if you
submit a written petition, you must submit three copies of the
petition. Identify comments with the docket number found in brackets in
the heading of this document. Comments and petitions that have not been
made publicly available on http://www.regulations.gov may be viewed in
the Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday.

    Dated: February 15, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04646 Filed 2-27-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 76, Number 35 (Tuesday, February 22, 2011)]
[Notices]
[Pages 9856-9859]
[FR Doc No: 2011-3905]

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

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2011-0010]

Qualification of Drivers; Exemption Applications; Vision

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

ACTION: Notice of applications for exemptions; request for comments.

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

SUMMARY: FMCSA announces receipt of applications from 23 individuals
for exemption from the vision requirement in the Federal Motor Carrier
Safety Regulations. If granted, the exemptions would enable these
individuals to qualify as drivers of commercial motor vehicles (CMVs)
in interstate commerce

without meeting the Federal vision standard.

DATES: Comments must be received on or before March 24, 2011.

ADDRESSES: You may submit comments bearing the Federal Docket
Management System (FDMS) Docket No. FMCSA-2011-0010 using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the on-line instructions for submitting
comments.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001.
     Hand Delivery: West Building Ground Floor, 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays Room W12-140, 1200
New Jersey Avenue, SE., Washington, DC, between.
     Fax: 1-202-493-2251.
    Instructions: Each submission must include the Agency name and the
docket numbers for this notice. Note that all comments received will be
posted without change to http://www.regulations.gov, including any
personal information provided. Please see the Privacy Act heading below
for further information.
    Docket: For access to the docket to read background documents or
comments, go to http://www.regulations.gov at any time or Room W12-140
on the ground level of the West Building, 1200 New Jersey Avenue, SE.,
Washington, DC, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays. The FDMS is available 24 hours each day, 365
days each year. If you want acknowledgment that we received your
comments, please include a self-addressed, stamped envelope or postcard
or print the acknowledgement page that appears after submitting
comments on-line.
    Privacy Act: Anyone may search the electronic form of all comments
received into any of our dockets by the name of the individual
submitting the comment (or of the person signing the comment, if
submitted on behalf of an association, business, labor union, etc.).
You may review DOT's Privacy Act Statement for the FDMS published in
the Federal Register on January 17, 2008 (73 FR 3316), or you may visit
http://edocket.access.gpo.gov/2008/pdf/E8-785.pdf.

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

SUPPLEMENTARY INFORMATION:

Background

    Under 49 U.S.C. 31136(e) and 31315, FMCSA may grant an exemption
from the Federal Motor Carrier Safety Regulations for a 2-year period
if it finds ``such exemption would likely achieve a level of safety
that is equivalent to, or greater than, the level that would be
achieved absent such exemption.'' FMCSA can renew exemptions at the end
of each 2-year period. The 23 individuals listed in this notice have
each requested such an exemption from the vision requirement in 49 CFR
391.41(b)(10), which applies to drivers of CMVs in interstate commerce.
Accordingly, the Agency will evaluate the qualifications of each
applicant to determine whether granting an exemption will achieve the
required level of safety mandated by statute.

Qualifications of Applicants

Jody L. Baker

    Mr. Baker, age 38, has had a retinal detachment and cystoid macular
edema in his right eye since 2000. The visual acuity in his right eye
is 20/20 and in his left eye, count-finger vision. Following an
examination in 2010, his ophthalmologist noted, ``Mr. Baker, it is my
opinion, without reservation, that you have sufficient vision to
perform the driving tasks required to operate a commerical vehicle.''
Mr. Baker reported that he has driven straight trucks for 17 years,
accumulating 1.2 million miles. He holds a Class E operator's license
from Missouri. His driving record for the last 3 years shows no crashes
and no convictions for moving violations in a CMV.

Gary W. Balcom

    Mr. Balcom, 69, has had age related macular degeneration since
2007. The best corrected visual acuity in his right eye is 20/400 and
in his left eye, 20/20. Following an examination in 2010, his
optometrist noted, ``I certify that, in my medical opinion, Mr. Balcom
has sufficient vision to perform the driving tasks required to operate
a commercial vehicle.'' Mr. Balcom reported that he has driven buses
for 7 years, accumulating 165,438 miles. He holds a Class B Commercial
Driver's License (CDL) from Michigan. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Jimmie L. Blue

    Mr. Blue, 71, has had juveline macular degeneration that has been
present in both eyes since age 21. The best corrected visual acuity in
his right eye is 20/100 and in his left eye, 20/30. Following an
examination in 2010, his optometrist noted, ``Thus it is my opinion
that he has sufficient vision to perform the driving tasks required to
operate a commercial vehicle.'' Mr. Blue reported that he has driven
tractor-trailer combinations for 45 years, accumulating 29 million
miles. He holds a Class A CDL from Montana. His driving record for the
last 3 years shows no crashes and one conviction for a moving violation
in a CMV; he was driving on the wrong side of the road.

Ronald Cook

    Mr. Cook, 53, has had optic nerve hypoplasia in his right eye since
birth. The best corrected visual acuity in his right eye is 20/60 and
in his left eye, 20/20. Following an examination in 2010, his
optometrist noted, ``In my opinion, Mr. Cook is capable of the visual
tasks required to operate a commercial vehicle.'' Mr. Cook reported
that he has driven straight trucks for 25 years, accumulating 150,000
miles and tractor-trailer combinations for 25 years, accumulating
187,500 miles. He holds a Class A CDL from Alabama. His driving record
for the last 3 years shows one crash in a CMV, for which he was not
cited, and no convictions for moving violations in a CMV.

James H. Corby

    Mr. Corby, 40, has loss of vision in his right eye due to corneal
graft surgery in 2000. The best corrected visual acuity in his right
eye is hand motion vision and in his left eye, 20/20. Following an
examination in 2010, his optometrist noted, ``In my medical opinion,
Jim can continue to drive a commercial vehicle, as he has done for the
last three years.'' Mr. Corby reported that he has driven straight
trucks for 3 years, accumulating 15,600 miles. He holds a Class C
operator's license from Pennsylvania. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

Bobby D. Cox

    Mr. Cox, 62, has had central vision loss in his right eye due to
macular hemes and scarring since 2002. The visual acuity in his right
eye is 20/400 and in his left eye, 20/20. Following an examination in
2010, his optometrist noted, ``In my professional opinion, Mr.

Cox should have no difficulty performing his duties while driving a
commercial vehicle and should continue driving as he has previously.''
Mr. Cox reported that he has driven straight trucks for 15 years,
accumulating 262,500 miles and tractor-trailer combinations for 19\1/2\
years accumulating 1.7 million miles. He holds a Class A CDL from
Tennessee. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

Wesley M. Creamer

    Mr. Creamer, 46, has had a nuclear cataract in his left eye due to
an injury sustained at age 9. The best corrected visual acuity in his
right eye is 20/20 and in his left eye, 20/400. Following an
examination in 2010, his optometrist noted, ``I believe he has
sufficient vision to perform the driving tasks required to operate a
commerical vehicle.'' Mr. Creamer reported that he has driven straight
trucks for 15\1/2\ years, accumulating 77,500 miles and tractor-trailer
combinations for 18 years, accumulating 270,000 miles. He holds a Class
A CDL from New Mexico. His driving record for the last 3 years shows no
crashes and two convictions for speeding in a CMV. In the first
incidence, he exceeded the speed limit by 10 miles per hour (MPH) and
in the second incidence, he exceeded the speed limit by 8 MPH.

Gerald S. Dennis

    Mr. Dennis, 51, has had strabismic amblyopia in his right eye since
birth. The best corrected visual acuity in his right eye is 20/200 and
in his left eye, 20/20. Following an examination in 2010, his
optometrist noted, ``In my medical opinion, Gerald Dennis, has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Dennis reported that he has driven straight
trucks for 4 years, accumulating 110,000 miles. He holds a Class D
operator's license from Iowa. His driving record for the last 3 years
shows no crashes and no convictions for moving violations in a CMV.

Cleveland E. Edwards

    Mr. Edwards, 39, has had refractive amblyopia in his left eye since
birth. The best corrected visual acuity in his right eye is 20/20 and
in his left eye, 20/800. Following an examination in 2010, his
optometrist noted, ``I certify that Cleveland Edwards has sufficient
vision to perform the driving tasks required to operate a commercial
vehicle.'' Mr. Edwards reported that he has driven straight trucks for
3 years, accumulating 93,504 miles and tractor-trailer combinations for
6 months, accumulating 24,600 miles. He holds a Class D operator's
license from Kentucky. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Thomas Grandfield

    Mr. Grandfield, 65, has had amblyopia in his right eye since
childhood. The best corrected visual acuity in his right eye is 20/200
and in his left eye, 20/20. Following an examination in 2010, his
ophthalmologist noted, ``I certify in my medical opinion, that Thomas
Grandfield has sufficient vision to perform the driving tasks required
to operate a commercial vehicle.'' Mr. Grandfield reported that he has
driven straight trucks for 37 years, accumulating 270,100 miles. He
holds a Class D operator's license from Massachusetts. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Bruce J. Greil

    Mr. Greil, 55, has had decreased vision in his right eye since 1990
due to coate's disease and a retinal detachment. The best corrected
visual acuity in his right eye is 20/400 and in his left eye, 20/20.
Following an examination in 2010, his optometrist noted, ``Bruce's
vision is stable and his vision is adequate to perform all required
driving tasks associated with a commercial vehicle.'' Mr. Greil
reported that he has driven straight trucks for 34 years, accumulating
1.6 million miles. He holds a Class B CDL from Wisconsin. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Johnnie L. Hall

    Mr. Hall, 51, has myopic degeneration and moderate amblyopia in his
left eye since childhood. The best corrected visual acuity in his right
eye is 20/25 and in his left eye, 20/100. Following an examination in
2010, his opthalmologist noted, ``In my medical opinion, he should
continue to drive commercial vehicles.'' Mr. Hall reported that he has
driven straight trucks for 25 years, accumulating 650,000 miles and
tractor-trailer combinations for 25 years, accumulating 1.4 million
miles. He holds a Class A CDL from Maryland. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Jerry L. Hofer

    Mr. Hofer, 58, has had a prosthetic left eye due to an eye injury
sustained at age 5. The best corrected visual acuity in his right eye
is 20/15. Following an examination in 2010, his optometrist noted,
``Mr. Hofer's vision has been stable for many years and I believe he
has adequate vision to drive and operate a commerical vehicle safely.''
Mr. Hofer reported that he has driven buses for 4.9 years, accumulating
31,850 miles. He holds a Class B CDL from New Mexico. His driving
record for the last 3 years shows no crashes and no convictions for
moving violations in a CMV.

Charles R. Hoeppner

    Mr. Hoeppner, 64, has had refractive amblyopia in his right eye
since childhood. The best corrected visual acuity in his right eye is
20/200 and in his left eye, 20/20. Following an examination in 2010,
his optometrist noted, ``According to the guidelines set by the U.S.
Department of Transportation, Federal Motor Carrier Safety
Administration, this patient has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' He holds a
Class C operator's license from Maryland. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Lester H. Killingsworth

    Mr. Killingsworth, 57, has had ambloypia in his left eye since
birth. The best corrected visual acuity in his right eye is 20/20 and
in his left eye, 20/200. Following an examination in 2010, his
optometrist noted, ``Therefore, in my medical opinion, I certify that
Mr. Killingsworth has sufficient vision to operate a commercial
vehicle.'' Mr. Killingsworth reported that he has driven straight
trucks for 4\1/2\ years, accumulating 540,000 miles. He holds a Class A
CDL from Texas. His driving record for the last 3 years shows no
crashes and no convictions for moving violations in a CMV.

Joseph F. Lopez, III

    Mr. Lopez, 53, has had a prosthetic right eye since childhood. The
best corrected visual acuity in his left eye is 20/20. Following an
examination in 2010, his optometrist noted, ``In my opinion, Joseph
Lopez has sufficient vision to perform the driving tasks required to
operate a commercial vehicle.'' Mr. Lopez reported that he has driven
straight trucks for 3 years, accumulating 24,000 miles. He holds a
Class D operator's license from Illinois. His driving record for the
last 3 years

shows no crashes and no convictions for moving violations in a CMV.

Thomas E. Moore

    Mr. Moore, 56, has had amblyopia in his right eye since childhood.
The best corrected visual acuity in his right eye is light perception
and in his left eye, 20/20. Following an examination in 2010, his
optometrist noted, ``Thomas has apparently operated a commercial
vehicle for many years and is, in my opinion, capable of continuing
this type of work.'' Mr. Moore reported that he has driven straight
trucks for 23 years, accumulating 230,000 miles. He holds a Class C
operator's license from Pennsylvania. His driving record for the last 3
years shows no crashes and no convictions for moving violations in a
CMV.

John F. Murphy

    Mr. Murphy, 51, has had strabismic amblyopia in his right eye since
birth. The best corrected visual acuity in his right eye is hand motion
vision and in his left eye, 20/20. Following an examination in 2010,
his optometrist noted, ``I feel that Mr. Murphy has stable strabismic
amblyopia OD that he has had since childbirth. I feel that he has
vision to operate a commercial vehicle''. Mr. Murphy reported that he
has driven straight trucks for 12 years, accumulating 624,000 miles and
tractor-trailer combinations for 15 years accumulating 1.6 million
miles. He holds a Class A CDL from Pennsylvania. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Michael O. Regentik

    Mr. Regentik, 56, has had central loss of vision in his right eye
due to an eye injury that occurred in 1985. The best corrected visual
acuity in his right eye is 20/400 and in his left eye, 20/25. Following
an examination in 2010, his opthamologist noted, ``I am currently
obtaining a copy of his previous records to compare against my exam;
however, it appears that Mr. Regentik has been driving commerical
vehicles for many years with this level of vision. I believe that his
vision is sufficient to continue to do so.'' Mr. Regentik reported that
he has driven straight trucks for 27 years, accumulating 1.1 million
miles and tractor-trailer combinations for 5 years accumulating 50,000
miles. He holds a Class A CDL from Michigan. His driving record for the
last 3 years shows no crashes and no convictions for moving violations
in a CMV.

Larry D. Robinson

    Mr. Robinson, 40, has had ambloypia in his left eye since birth.
The best corrected visual acuity in his right eye is 20/20 and in his
left eye, 20/400. Following an examination in 2010, his optometrist
noted, ``It is my medical opinion that Larry Robinson has sufficient
vision to perform driving tasks required to operate a commercial
vehicle.'' Mr. Robinson reported that he has driven straight trucks 12
years, accumulating 240,000 miles. He holds a Class B CDL from
Missouri. His driving record for the last 3 years shows no crashes and
no convictions for moving violations in a CMV.

David Serrano

    Mr. Serrano, 46, has had amblyopia in his left eye since childhood.
The visual acuity in his right eye is 20/25 and in his left eye, 20/
200. Following an examination in 2010, his optometrist noted, ``In my
medical opinion, Mr. Serrano has sufficient vision to perform the
driving tasks required to operate a commercial vehicle.'' Mr. Serrano
reported that he has driven straight trucks for 2 years, accumulating
6,000 miles and tractor-trailer combinations for 6 years accumulating
36,000 miles. He holds a Class A CDL from Florida. His driving record
for the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Bill J. Thierolf

    Mr. Thierolf, 55, has had loss of vision in his left eye due to
retinal detachment since 1981. The visual acuity in his right eye is
20/20 and in his left eye, count-finger vision. Following an
examination in 2010, his optometrist noted, ``Mr. Thierolf has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Thierolf reported that he has driven straight
trucks for 26 years, accumulating 520,000 miles and tractor-trailer
combinations for 20 years accumulating 600,000 miles. He holds a Class
A CDL from Nebraska. His driving record for the last 3 years shows one
crash, which he was not cited for, and no convictions for moving
violations in a CMV.

Edward Timpson

    Mr. Timpson, 76, has had amblyopia in his right eye since birth.
The best corrected visual acuity in his right eye is 20/200 and in his
left eye, 20/25. Following an examination in 2010, his optometrist
noted, ``I certify in my medical opinion that Mr. Timpson has
sufficient vision to perform the driving tasks required to operate a
commercial vehicle.'' Mr. Timpson reported that he has driven tractor-
trailer combinations for 58 years accumulating 522,000 miles. He holds
a Class 10 operator's license from Rhode Island. His driving record for
the last 3 years shows no crashes and no convictions for moving
violations in a CMV.

Request for Comments

    In accordance with 49 U.S.C. 31136(e) and 31315, FMCSA requests
public comment from all interested persons on the exemption petitions
described in this notice. The Agency will consider all comments
received before the close of business March 24, 2011. Comments will be
available for examination in the docket at the location listed under
the ADDRESSES section of this notice. The Agency will file comments
received after the comment closing date in the public docket, and will
consider them to the extent practicable. In addition to late comments,
FMCSA will also continue to file, in the public docket, relevant
information that becomes available after the comment closing date.
Interested persons should monitor the public docket for new material.

    Issued on: February 15, 2011.
Larry W. Minor,
Associate Administrator, Office of Policy.
[FR Doc. 2011-3905 Filed 2-18-11; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register Volume 84, Number 113 (Wednesday, June 12, 2019)]
[Rules and Regulations]
[Pages 27200-27201]
[FR Doc No: 2019-12389]

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

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2015-D-2496]

Premarket Tobacco Product Applications for Electronic Nicotine
Delivery Systems; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notification of availability.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a final guidance for industry entitled ``Premarket
Tobacco Product Applications for Electronic Nicotine Delivery Systems,
Guidance for Industry.'' Given the relatively new presence of
electronic nicotine delivery systems (ENDS) on the U.S. market and
FDA's final rule deeming these products to be subject to the tobacco
product authorities in the Federal Food, Drug, and Cosmetic Act (FD&C
Act), FDA expects to receive premarket tobacco product application
(PMTA) submissions from manufacturers of ENDS. This guidance is
intended to assist applicants to prepare PMTAs for ENDS products.

DATES: The announcement of the guidance is published in the Federal
Register on June 12, 2019.

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-2015-D-2496 for ``Premarket Tobacco Product Applications for
Electronic Nicotine Delivery Systems, Guidance for Industry.'' 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 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Center for Tobacco Products, Food and Drug Administration, Document
Control Center, 10903 New Hampshire Ave., Bldg. 71, Rm. G335, Silver
Spring, MD 20993-0002. Send one self-addressed adhesive label to assist
that office in processing your request or include a fax number to which
the guidance document may be sent. See the SUPPLEMENTARY INFORMATION
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Paul Hart, Center for Tobacco
Products, Food and Drug Administration, Document Control Center, 10903
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002,
1-877-CTP-1373, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Premarket Tobacco Product Applications for Electronic
Nicotine Delivery Systems.''
    On June 22, 2009, the President signed the Family Smoking
Prevention and Tobacco Control Act (Tobacco Control Act) (Pub. L. 111-
31) into law. The Tobacco Control Act amended the FD&C Act and granted
FDA authority to regulate the manufacture, marketing, and distribution
of tobacco products to protect public health generally and to reduce
tobacco use by minors. Under section 901(b) of the FD&C Act (21 U.S.C.
387a(b)), FDA's tobacco product authorities in chapter IX of the FD&C
Act apply to all cigarettes, cigarette tobacco, roll-your-own tobacco,
and smokeless tobacco and to any other tobacco products that the
Secretary of Health and Human Services by regulation deems to be
subject to chapter IX. On May 10, 2016, in the Federal Register, FDA
published its final rule, ``Deeming Tobacco Products To Be Subject to
the Federal Food, Drug, and Cosmetic Act, as Amended by the Family
Smoking Prevention and Tobacco Control Act; Restrictions on the Sale
and Distribution of Tobacco Products and Required Warning Statements
for Tobacco Products'' (Deeming rule) extending FDA's tobacco product
authority to ENDS, among other products (81 FR 28973). In the same
issue of the Federal Register, FDA concurrently announced the
availability of the draft guidance, ``Premarket Tobacco Product
Applications for Electronic Nicotine Delivery Systems, Draft Guidance
for Industry; Availability; Agency Information Collection Activities;
Proposed Collection; Comment Request'' (81 FR 28781). FDA received
comments on the draft guidance and those comments were considered as
the guidance was finalized. Changes made as a result of public comments
include recommendations for constituent testing, single applications
for new tobacco products that an applicant intends to market as a
modified risk tobacco product, and the number batches and replicates
related to product testing.
    Under section 910 of the FD&C Act (21 U.S.C. 387j), persons seeking
to market a new tobacco product (as defined in section 910(a)(1) of the
FD&C Act) must first submit a PMTA to FDA and obtain a marketing
authorization order, unless FDA has issued an order that the new
tobacco product is substantially equivalent to a tobacco product
commercially marketed in the United States as of February 15, 2007, or
the new tobacco product is exempt from demonstrating substantial
equivalence pursuant to the reasons outlined in section 905(j)(3) of
the FD&C Act (21 U.S.C. 387e(j)(3)). ENDS products, the subject of this
guidance, likely would be considered new tobacco products. Given the
relatively new presence of ENDS on the U.S. market, FDA anticipates
that many manufacturers of these new tobacco products will seek a
marketing authorization order by filing a PMTA. This guidance explains,
among other things, when a PMTA is required, general procedures for
review of an ENDS PMTA, what information the FD&C Act requires
applicants to submit in a PMTA, and what information FDA recommends
applicants submit in an ENDS PMTA to show whether permitting such new
tobacco product to be marketed is appropriate for the protection of the
public health.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on PMTAs for ENDS. It does not establish any
rights for any person and is not binding on FDA or the public. You can
use an alternative approach if it satisfies the requirements of the
applicable statutes and regulations. This guidance is not subject to
Executive Order 12866.

III. 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 21 CFR 1107.1 have been approved under
OMB control number 0910-0768.

IV. Electronic Access

    Persons with access to the internet may obtain an electronic
version of the guidance at either https://www.regulations.gov or
https://www.fda.gov/tobacco-products/products-guidance-regulations/rules-regulations-and-guidance.

    Dated: June 7, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-12389 Filed 6-11-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 84, Number 22 (Friday, February 1, 2019)]
[Notices]
[Pages 1163-1164]
[FR Doc No: 2019-00666]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0539]

Immunogenicity Testing of Therapeutic Protein Products--
Developing and Validating Assays for Anti-Drug Antibody Detection;
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Immunogenicity Testing of Therapeutic Protein Products--Developing
and Validating Assays for Anti-Drug Antibody Detection.'' This guidance
provides recommendations to facilitate industry's development and
validation of assays for assessment of the immunogenicity of
therapeutic protein products during clinical trials. The guidance
applies to assays for the detection of anti-drug antibodies (ADAs) and
may also apply to some peptides, oligonucleotides, and combination
products on a case-by-case basis. The guidance includes recommendations
regarding the development and validation of screening assays,
confirmatory assays, titration assays, and neutralization assays. This
guidance finalizes the revised draft guidance for industry entitled
``Assay Development and Validation for Immunogenicity Testing of
Therapeutic Protein Products'' issued in April 2016 and includes a
revised title.

DATES: The announcement of the guidance is published in the Federal
Register on February 1, 2019.

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-2009-D-0539 for ``Immunogenicity Testing of Therapeutic Protein
Products--Developing and Validating Assays for Anti-Drug Antibody
Detection.'' 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 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Ebla Ali-Ibrahim, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6302, Silver Spring, MD 20993, 301-796-
3691; or Stephen Ripley, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Immunogenicity Testing of Therapeutic Protein Products--
Developing and Validating Assays for Anti-Drug Antibody Detection.''
This guidance finalizes the revised draft guidance for industry
entitled ``Assay Development and Validation for Immunogenicity Testing
of Therapeutic Protein Products'' issued in April 2016. Changes made to
the guidance took into consideration comments received. In addition to
editorial changes primarily for clarification, this guidance includes
updated information on titration and confirmatory assays and an
additional discussion of immunogenicity risk assessment.
    Immune responses to therapeutic protein products have the potential
to affect product pharmacokinetics, pharmacodynamics, safety, and
efficacy. The clinical effects of patient immune responses are highly
variable, ranging from no measurable effect to extremely harmful.
Detection and analysis of ADA formation is a helpful tool in
understanding potential patient immune responses. Information on immune
responses observed during clinical trials, particularly the incidence
of ADA induction or any implications of ADA responses affecting
pharmacokinetics, pharmacodynamics, safety, and efficacy, is crucial
for any therapeutic protein product development program. Accordingly,
such information, if applicable, should be included in the prescribing
information as a subsection of the ADVERSE REACTIONS section entitled
``Immunogenicity.''
    In general, results from assays for detection of ADA facilitate
understanding of the immunogenicity, pharmacokinetics,
pharmacodynamics, safety, and efficacy of therapeutic protein products.
However, the detection of ADA is dependent on key operating parameters
of the assays (for example, sensitivity, specificity), which vary
between assays. Therefore, the development of valid, sensitive,
specific, and selective assays to measure ADA responses is a key aspect
of therapeutic protein product development.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current thinking of FDA on ``Immunogenicity Testing of Therapeutic
Protein Products--Developing and Validating Assays for Anti-Drug
Antibody Detection.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations. This guidance is not subject to Executive Order 12866.

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 21 CFR part 201 have been approved under
OMB control number 0910-0572; the collections of information in 21 CFR
part 211 have been approved under OMB control number 0910-0139; the
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 314 have been approved under OMB control number 0910-0001; the
collections of information in 21 CFR part 58 have been approved under
OMB control number 0910-0119; and the collections of information in 21
CFR part 601 have been approved under OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or
https://www.regulations.gov.

    Dated: January 16, 2019.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2019-00666 Filed 1-31-19; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 87, Number 50 (Tuesday, March 15, 2022)]
[Notices]
[Page 14528]
[FR Doc No: 2022-05424]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL22-32-000]

PJM Interconnection, L.L.C.; Notice of Institution of Section 206
Proceeding and Refund Effective Date

    On February 28, 2022, the Commission issued an order in Docket No.
EL22-32-000, pursuant to section 206 of the Federal Power Act (FPA), 16
U.S.C. 824e, instituting an investigation into whether PJM
Interconnection, L.L.C.'s existing Financial Transmission Right (FTR)
Credit Requirement is unjust, unreasonable, unduly discriminatory or
preferential, or otherwise unlawful. PJM Interconnection, L.L.C., 178
FERC ] 61,146 (2021).
    The refund effective date in Docket No. EL22-32-000, established
pursuant to section 206(b) of the FPA, will be the date of publication
of this notice in the Federal Register.
    Any interested person desiring to be heard in Docket No. EL22-32-
000 must file a notice of intervention or motion to intervene, as
appropriate, with the Federal Energy Regulatory Commission, in
accordance with Rule 214 of the Commission's Rules of Practice and
Procedure, 18 CFR 385.214 (2021), within 21 days of the date of
issuance of the order.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    The Commission strongly encourages electronic filings of comments,
protests and interventions in lieu of paper using the ``eFile'' link at
http://www.ferc.gov. In lieu of electronic filing, you may submit a
paper copy. Submissions sent via the U.S. Postal Service must be
addressed to: Kimberly D. Bose, Secretary, Federal Energy Regulatory
Commission, 888 First Street NE, Room 1A, Washington, DC 20426.
Submissions sent via any other carrier must be addressed to: Kimberly
D. Bose, Secretary, Federal Energy Regulatory Commission, 12225 Wilkins
Avenue, Rockville, Maryland 20852.

    Dated: March 9, 2022.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2022-05424 Filed 3-14-22; 8:45 am]
BILLING CODE 6717-01-P