[Federal Register Volume 80, Number 187 (Monday, September 28, 2015)]
[Notices]
[Pages 58318-58321]
[FR Doc No: 2015-24517]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75966; File No. SR-NYSE-2015-39]

Self-Regulatory Organizations; New York Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Amending Supplementary Material .20 to Rule 103 To Permit Member
Organizations That Operate as Designated Market Maker Units on the
Exchange and Also Operate DMM Units on the NYSE MKT LLC To Make an
Adjustment to Excess Net Capital

September 22, 2015.
    Pursuant to section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on September 8, 2015, New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III, below, which Items have been substantially
prepared by the Exchange. The Commission is publishing this notice to
solicit comments on the proposed rule change from interested persons.
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    \1\ See 15 U.S.C. 78s(b)(1).
    \2\ See 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend Supplementary Material .20 to Rule
103 (``NYSE Rule 103.20''), to permit member organizations that operate
as Designated Market Maker (``DMM'') units on the Exchange and also
operate DMM units on the NYSE MKT LLC (``NYSE MKT'') to make an
adjustment to Excess Net Capital. The text of the proposed rule change
is available on the Exchange's Web site at www.nyse.com, at the
principal office of the Exchange, and 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, the Exchange 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. The Exchange 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
    The Exchange proposes to amend NYSE Rule 103.20, which sets forth
the net liquid assets requirements for a member organization that
operates as DMM a [sic] unit on the Exchange,\3\ to permit such DMM
unit to make an adjustment to Excess Net Capital when calculating Net
Liquid Assets if it also operates as a DMM unit on NYSE MKT. The
proposed adjustment would permit a DMM unit to add back to its Excess
Net Capital the lesser of (1) the actual haircuts under Securities and
Exchange Commission (``SEC'' or ``Commission'') [sic] Rule 15c3-1 (the
``SEC Net Capital Rule'') \4\ on its NYSE MKT DMM dealer positions, or
(2) the NYSE MKT DMM tentative net capital requirement calculated
according to NYSE MKT Rule 103.20--Equities (``NYSE MKT Rule 103.20'').
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    \3\ Pursuant to Rule 2(j), a DMM unit is defined as a member
organization or unit within a member organization that has been
approved to act as a DMM unit under Rule 98. Pursuant to Rule 2(i),
a DMM is defined as an individual member, officer, partner, employee
or associated person of a DMM unit who is approved by the Exchange
to act in the capacity of a DMM. All references to rules herein are
to NYSE rules, unless otherwise noted.
    \4\ 17 CFR 240.15c3-1.
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Background and Proposed Rule Change
    NYSE Rule 103.20 sets forth a Net Liquid Assets requirement for DMM
units that exceed [sic] the SEC Net Capital Rule minimum net capital
requirement applicable to market-making activities. The purpose of the
Exchange's requirement is to reasonably assure that each DMM unit
maintains sufficient liquidity to carry out its obligation to maintain
a fair and orderly market in its assigned securities in times of market
stress.
    Rule 103.20(a) defines ``Net Liquid Assets'' as the sum of (A)
``Excess Net Capital'' and (B) ``Liquidity'' dedicated to the DMM unit.
Excess Net Capital has the same meaning as the term excess net capital
as computed in accordance with the SEC Net Capital Rule, which means
the amount identified as item number 3770 of SEC Form X-17A-5 (``FOCUS
Report''), except for DMM units that compute net capital under the
alternative standard, for which it would mean item number 3910 of the
FOCUS Report. Liquidity is defined as undrawn or actual borrowings that
are dedicated to the DMM unit's business, as specified in Rule
103.20(a)(3)(A)-(C). Rule 103.20 requires that aggregate Net Liquid
Assets of all DMM units equal at least $125 million and that each DMM
unit maintain or have allocated to it Net Liquid Assets that are the
greater of (1) $1 million, or (2) $125,000 for each one-tenth of one
percent (0.1%) of Exchange transaction dollar volume \5\ in its
registered securities.
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    \5\ The term ``Exchange transaction dollar volume'' means the
most recent Statistical Data, calculated and provided by the NYSE on
a monthly basis.
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    Pursuant to NYSE MKT Rule 103.20, DMM units on NYSE MKT are
required to calculate their NYSE MKT tentative net capital (``TNC'')
requirement based on the greater of (i) $1,000,000 or (ii) the haircut
charges on a theoretical position of 60 trading units of each assigned
NYSE MKT DMM security and 20 trading units of each assigned Unlisted
Trading Privileges DMM security. For NYSE MKT DMM units that also
operate as DMMs on the NYSE, the haircuts on NYSE MKT DMM positions as
computed pursuant to the SEC Net Capital Rule are deducted in computing
Net Liquid Assets under NYSE Rule 103.20. DMM units operating on NYSE
and NYSE MKT therefore incorporate the market risk charges (i.e.,
haircuts) on the NYSE MKT positions twice: First, because the NYSE and
NYSE MKT DMM capital requirements are cumulative,\6\ Excess Net Capital
available to meet the requirement of NYSE Rule 103.20 must be reduced
by the amount of capital needed to satisfy the NYSE MKT Rule 103.20
requirement and, second, in computing Net Liquid Assets under NYSE Rule
103.20, the determination of Excess Net Capital incorporates several
adjustments, such as a reduction for haircuts on proprietary positions,
including NYSE MKT DMM positions.
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    \6\ NYSE Rule 103.20(b)(2) requires that Excess Net Capital be
``dedicated exclusively to the DMM unit's activities and shall not
be used by other business units.'' Accordingly, the portion of
Excess Net Capital used to meet the DMM's NYSE Rule 103.20
requirement cannot include the capital which is being used to meet
the firm's NYSE MKT DMM requirement.
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    The Exchange accordingly proposes to add a new section (6) to NYSE
Rule 103.20(b), which sets forth the minimum Net Liquid Assets
requirement,\7\ to permit a DMM unit operating on both the NYSE and
NYSE MKT to avoid duplicative reductions to Excess Net Capital by
adding back the lesser of actual SEC Net Capital Rule haircuts on the
firm's NYSE MKT DMM positions or the NYSE MKT DMM TNC requirement
calculated pursuant to NYSE MKT Rule 103.20. The proposed adjustment
would permit a DMM unit operating on both marketplaces to have Excess
Net Capital reduced once for NYSE MKT DMM haircuts under NYSE Rule
103.20, thereby adjusting the DMM unit's capital available to meet its
Net Liquid Assets requirement. The Exchange believes that this change
would result in a more efficient utilization of capital by DMM units
who operate on both exchanges.
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    \7\ The Exchange also proposes to add a reference to the
proposed adjustment in NYSE Rule 103.20(a)(1)(A), which defines the
term ``Net Liquid Assets.''
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    The Exchange believes that the proposed change would not diminish
the current levels of capital maintained by DMM units operating on both
markets. The Exchange notes that it would continue to assess DMM unit
financial requirements and that the Financial Industry Regulatory
Authority, Inc. (``FINRA''), [sic] on behalf of the Exchange, would
continue to monitor DMM unit compliance with NYSE Rule 103.20.
    The Exchange proposes to notify DMM units of the implementation
date of this rule change via a Member Education Bulletin.
    The proposed change is not otherwise intended to address any other
issues and the Exchange is not aware of any problems that DMM units
would have in complying with the proposed change.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act,\8\ in general, and furthers the
objectives of section 6(b)(5) of the Act,\9\ in particular, because it
is designed to prevent fraudulent and manipulative acts and practices,
to promote just and equitable principles of trade, to foster
cooperation and coordination with persons engaged in regulating,
clearing, settling, processing information with respect to, and
facilitating transactions in securities, to remove impediments to, and
perfect the mechanisms of, a free and open market and a national market
system and, in

general, to protect investors and the public interest and because it is
not designed to permit unfair discrimination between customers,
issuers, brokers, or dealers.
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    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
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    The Exchange believes that the proposed change would remove
impediments to, and perfect the mechanisms of, a free and open market
and a national market system by reducing the financial burden on DMM
units operating on both the Exchange and NYSE MKT by eliminating the
requirement to apply duplicative NYSE MKT DMM dealer haircuts. The
Exchange believes that permitting DMM units operating on both
marketplaces to take an adjustment would prevent those units from
taking NYSE MKT DMM positions into consideration twice as part of the
Excess Net Capital calculation under NYSE Rule 103.20, thereby
potentially lowering the DMM units' Excess Net Capital available to
meet their Net Liquid Assets requirements. The Exchange believes that
the proposed rule would continue to assure that DMM units have
sufficient liquidity to carry out their obligations to maintain an
orderly market in their assigned securities in times of market stress.
    The Exchange further believes that the proposed change would
protect investors and the public interest by reducing existing barriers
to entry for new DMM units and mitigating the potential loss of
existing DMM units. Stabilizing and increasing the pool of DMM units
with a more efficient financial structure would be beneficial to the
Exchange and would also enhance market quality and thereby support
investor protection and public interest goals.
    Finally, the Exchange believes that it is subject to significant
competitive forces, as described below in the Exchange's statement
regarding the burden on competition.
    For the foregoing reasons, the Exchange believes that the proposal
is consistent with the Act.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act. The proposed change is
designed to permit DMM units operating on the Exchange and NYSE MKT to
make an adjustment to Excess Net Capital to add back haircuts on NYSE
MKT DMM positions and avoid taking these haircuts into consideration
twice, but would not affect the overall level thereof. This proposed
change would eliminate a potential barrier to entry for new DMM units
interested in operating on both markets, thereby promoting competition.
    The Exchange notes that market makers and traders on other U.S.
equity exchanges are not subject to net capital requirements beyond
those required by the SEC Net Capital Rule. Nonetheless, DMM units have
unique affirmative obligations and the Exchange continues to believe
that it is appropriate that their financial requirements be higher than
other market participants. The proposal would support competition by
making DMM unit financial requirements more manageable for member
organizations, including both existing and potential future DMM units,
and would thereby promote greater interest in seeking DMM unit
appointments on the Exchange. Finally, the Exchange notes that it
operates in a highly competitive market in which market participants
can readily favor competing venues. In such an environment, the
Exchange must continually review, and consider adjusting the services
it offers and the requirements it imposes to remain competitive with
other U.S. equity exchanges.
    For the reasons described above, the Exchange believes that the
proposed rule change reflects this competitive environment.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The Exchange has filed the proposed rule change pursuant to section
19(b)(3)(A)(iii) of the Act \10\ and Rule 19b-4(f)(6) thereunder.\11\
Because the 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 prior to
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, the proposed rule change has become
effective pursuant to section 19(b)(3)(A) of the Act and Rule 19b-
4(f)(6)(iii) thereunder.
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    \10\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \11\ 17 CFR 240.19b-4(f)(6).
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    A proposed rule change filed under Rule 19b-4(f)(6) \12\ normally
does not become operative prior to 30 days after the date of the
filing. However, pursuant to Rule 19b4(f)(6)(iii),\13\ the Commission
may designate a shorter time if such action is consistent with the
protection of investors and the public interest.
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    \12\ 17 CFR 240.19b-4(f)(6).
    \13\ 17 CFR 240.19b-4(f)(6)(iii).
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    At any time within 60 days of the filing of such 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 under
section 19(b)(2)(B)\14\ of the Act to determine whether the proposed
rule change should be approved or disapproved.
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    \14\ 15 U.S.C. 78s(b)(2)(B).
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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-NYSE-2015-39 on the subject line.

Paper Comments

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

    All submissions should refer to File Number SR-NYSE-2015-39. 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 10:00 a.m. and 3:00 p.m. Copies of
the filing also will be available for inspection and copying at the
principal office of the Exchange. 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-NYSE-2015-39 and
should be submitted on or before October 19, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
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    \15\ See 17 CFR 200.30-3(a)(12).
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Robert W. Errett,
Deputy Secretary.
[FR Doc. 2015-24517 Filed 9-25-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 84, Number 64 (Wednesday, April 3, 2019)]
[Rules and Regulations]
[Pages 12938-12940]
[FR Doc No: 2019-06448]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2019-0003; Internal Agency Docket No. FEMA-8573]

Suspension of Community Eligibility

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final rule.

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SUMMARY: This rule identifies communities where the sale of flood
insurance has been authorized under the National Flood Insurance
Program (NFIP) that are scheduled for suspension on the effective dates
listed within this rule because of noncompliance with the floodplain
management requirements of the program. If the Federal Emergency
Management Agency (FEMA) receives documentation that the community has
adopted the required floodplain management measures prior to the
effective suspension date given in this rule, the suspension will not
occur and a notice of this will be provided by publication in the
Federal Register on a subsequent date. Also, information identifying
the current participation status of a community can be obtained from
FEMA's Community Status Book (CSB). The CSB is available at https://www.fema.gov/national-flood-insurance-program-community-status-book.

DATES: Effective Dates: The effective date of each community's
scheduled suspension is the third date (``Susp.'') listed in the third
column of the following tables.

FOR FURTHER INFORMATION CONTACT: If you want to determine whether a
particular community was suspended on the suspension date or for
further information, contact Adrienne L. Sheldon, PE, CFM, Federal
Insurance and Mitigation Administration, Federal Emergency Management
Agency, 400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The NFIP enables property owners to purchase
Federal flood insurance that is not otherwise generally available from

private insurers. In return, communities agree to adopt and administer
local floodplain management measures aimed at protecting lives and new
construction from future flooding. Section 1315 of the National Flood
Insurance Act of 1968, as amended, 42 U.S.C. 4022, prohibits the sale
of NFIP flood insurance unless an appropriate public body adopts
adequate floodplain management measures with effective enforcement
measures. The communities listed in this document no longer meet that
statutory requirement for compliance with program regulations, 44 CFR
part 59. Accordingly, the communities will be suspended on the
effective date in the third column. As of that date, flood insurance
will no longer be available in the community. We recognize that some of
these communities may adopt and submit the required documentation of
legally enforceable floodplain management measures after this rule is
published but prior to the actual suspension date. These communities
will not be suspended and will continue to be eligible for the sale of
NFIP flood insurance. A notice withdrawing the suspension of such
communities will be published in the Federal Register.
    In addition, FEMA publishes a Flood Insurance Rate Map (FIRM) that
identifies the Special Flood Hazard Areas (SFHAs) in these communities.
The date of the FIRM, if one has been published, is indicated in the
fourth column of the table. No direct Federal financial assistance
(except assistance pursuant to the Robert T. Stafford Disaster Relief
and Emergency Assistance Act not in connection with a flood) may be
provided for construction or acquisition of buildings in identified
SFHAs for communities not participating in the NFIP and identified for
more than a year on FEMA's initial FIRM for the community as having
flood-prone areas (section 202(a) of the Flood Disaster Protection Act
of 1973, 42 U.S.C. 4106(a), as amended). This prohibition against
certain types of Federal assistance becomes effective for the
communities listed on the date shown in the last column. The
Administrator finds that notice and public comment procedures under 5
U.S.C. 553(b), are impracticable and unnecessary because communities
listed in this final rule have been adequately notified.
    Each community receives 6-month, 90-day, and 30-day notification
letters addressed to the Chief Executive Officer stating that the
community will be suspended unless the required floodplain management
measures are met prior to the effective suspension date. Since these
notifications were made, this final rule may take effect within less
than 30 days.
    National Environmental Policy Act. FEMA has determined that the
community suspension(s) included in this rule is a non-discretionary
action and therefore the National Environmental Policy Act of 1969 (42
U.S.C. 4321 et seq.) does not apply.
    Regulatory Flexibility Act. The Administrator has determined that
this rule is exempt from the requirements of the Regulatory Flexibility
Act because the National Flood Insurance Act of 1968, as amended,
Section 1315, 42 U.S.C. 4022, prohibits flood insurance coverage unless
an appropriate public body adopts adequate floodplain management
measures with effective enforcement measures. The communities listed no
longer comply with the statutory requirements, and after the effective
date, flood insurance will no longer be available in the communities
unless remedial action takes place.
    Regulatory Classification. This final rule is not a significant
regulatory action under the criteria of section 3(f) of Executive Order
12866 of September 30, 1993, Regulatory Planning and Review, 58 FR
51735.
    Executive Order 13132, Federalism. This rule involves no policies
that have federalism implications under Executive Order 13132.
    Executive Order 12988, Civil Justice Reform. This rule meets the
applicable standards of Executive Order 12988.
    Paperwork Reduction Act. This rule does not involve any collection
of information for purposes of the Paperwork Reduction Act, 44 U.S.C.
3501 et seq.

List of Subjects in 44 CFR Part 64

    Flood insurance, Floodplains.

    Accordingly, 44 CFR part 64 is amended as follows:

PART 64--[AMENDED]

0
1. The authority citation for Part 64 continues to read as follows:

     Authority:  42 U.S.C. 4001 et seq.; Reorganization Plan No. 3
of 1978, 3 CFR, 1978 Comp.; p. 329; E.O. 12127, 44 FR 19367, 3 CFR,
1979 Comp.; p. 376.

Sec.  64.6  [Amended]

0
2. The tables published under the authority of Sec.  64.6 are amended
as follows:

----------------------------------------------------------------------------------------------------------------
                                                Effective date
                                                authorization/
                                  Community     cancellation of    Current effective map   Date certain federal
      State and location             No.         sale of flood             date            assistance no longer
                                                 insurance in                               available in SFHAs
                                                   community
----------------------------------------------------------------------------------------------------------------
          Region III

West Virginia:
    Fairmont, City of, Marion         540099  February 14, 1977,  April 5, 2019.........  April 5, 2019.
     County.                                   Emerg; July 2,
                                               1987, Reg; April
                                               5, 2019, Susp.
    Granville, Town of,               540272  April 7, 1975,      ......do *............   Do.
     Monongalia County.                        Emerg; December
                                               15, 1983, Reg;
                                               April 5, 2019,
                                               Susp.
    Marion County,                    540097  August 21, 1975,    ......do..............   Do.
     Unincorporated Areas.                     Emerg; July 4,
                                               1988, Reg; April
                                               5, 2019, Susp.
    Monongalia County,                540139  October 31, 1975,   ......do..............   Do.
     Unincorporated Areas.                     Emerg; May 1,
                                               1984, Reg; April
                                               5, 2019, Susp.
    Morgantown, City of,              540141  January 23, 1975,   ......do..............   Do.
     Monongalia County.                        Emerg; August 1,
                                               1979, Reg; April
                                               5, 2019, Susp.
    Star City, Town of,               540273  April 18, 1975,     ......do..............   Do.
     Monongalia County.                        Emerg; August 1,
                                               1978, Reg; April
                                               5, 2019, Susp.
    Westover, City of,                540274  January 27, 1975,   ......do..............   Do.
     Monongalia County.                        Emerg; August 1,
                                               1978, Reg; April
                                               5, 2019, Susp.
           Region VI

Texas:
    Millsap, City of, Parker          480107  N/A, Emerg; August  ......do..............   Do.
     County.                                   28, 2013, Reg;
                                               April 5, 2019,
                                               Susp.
    Mingus, City of, Palo             480518  January 28, 1998,   ......do..............   Do.
     Pinto County.                             Emerg; September
                                               1, 2004, Reg;
                                               April 5, 2019,
                                               Susp.

    Ranger, City of, Eastland         480205  December 15, 1998,  ......do..............   Do.
     County.                                   Emerg; July 1,
                                               1999, Reg; April
                                               5, 2019, Susp.
    Strawn, City of, Palo             480965  May 20, 1987,       .......do.............   Do.
     Pinto County.                             Emerg; November
                                               1, 1989, Reg;
                                               April 5, 2019,
                                               Susp.
    Weatherford, City of,             480522  September 13,       .......do.............   Do.
     Parker County.                            1974, Emerg;
                                               August 5, 1986,
                                               Reg; April 5,
                                               2019, Susp.
           Region IX

California: Foster City, City         060318  April 13, 1973,     April 5, 2019.........  April 5, 2019.
 of, San Mateo County                          Emerg; January 7,
                                               1977, Reg; April
                                               5, 2019, Susp.
----------------------------------------------------------------------------------------------------------------
* ......do = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: March 22, 2019.
Katherine B. Fox,
Assistant Administrator for Mitigation, Federal Insurance and
Mitigation Administration--FEMA Resilience, Department of Homeland
Security, Federal Emergency Management Agency.
[FR Doc. 2019-06448 Filed 4-2-19; 8:45 am]
 BILLING CODE 9110-12-P


[Federal Register: June 1, 2006 (Volume 71, Number 105)]
[Proposed Rules]
[Page 31129]
[DOCID:fr01jn06-25]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R05-OAR-2006-0052; FRL-8177-9]

Approval and Promulgation of Air Quality Implementation Plans;
Ohio: Carbon Monoxide Maintenance Plan Updates; Limited Maintenance
Plan

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve an October 20, 2005, request from Ohio for a State
Implementation Plan (SIP) revision of the Cuyahoga County carbon
monoxide (CO) maintenance plan. The CO maintenance plan revision is an
update to the current approved maintenance plan and continues to
demonstrate maintenance of the CO National Ambient Air Quality Standard
(NAAQS) for an additional 10 years. The maintenance plan revision is
submitted as a limited maintenance plan for the Cuyahoga County, Ohio
carbon monoxide area. This submittal is to meet a requirement under the
Clean Air Act.

DATES: Comments must be received on or before July 3, 2006.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R05-
OAR-2006-0052, by one of the following methods:
     http://www.regulations.gov: Follow the on-line

instructions for submitting comments.
     E-mail<EMAIL_ADDRESS>     Fax:<PHONE_NUMBER>.
     Mail: John M. Mooney, Chief, Criteria Pollutant Section,
(AR-18J), Air Programs Branch, Air and Radiation Division, U.S.
Environmental Protection Agency, 77 West Jackson Boulevard, Chicago,
Illinois 60604.
     Hand Delivery: John M. Mooney, Chief, Criteria Pollutant
Section, (AR-18J), Air Programs Branch, Air and Radiation Division,
U.S. Environmental Protection Agency, 77 West Jackson Boulevard,
Chicago, Illinois 60604. Such deliveries are only accepted during the
Regional Office normal hours of operation, and special arrangements
should be made for deliveries of boxed information. The Regional Office
official hours of business are Monday through Friday, 8:30 a.m. to 4:30
p.m. excluding Federal holidays.
    Please see the direct final rule which is located in the Rules
section of this Federal Register for detailed instructions on how to
submit comments.

FOR FURTHER INFORMATION CONTACT: Patricia Morris, Environmental
Scientist, Criteria Pollutant Section, Air Programs Branch (AR-18J),
Environmental Protection Agency, Region 5, 77 West Jackson Boulevard,
Chicago, Illinois 60604,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Final Rules section of this Federal
Register, EPA is approving the State's SIP submittal as a direct final
rule without prior proposal because the Agency views this as a
noncontroversial submittal and anticipates no adverse comments. A
detailed rationale for the approval is set forth in the direct final
rule. If no adverse comments are received in response to this rule, no
further activity is contemplated. If EPA receives adverse comments, the
direct final rule will be withdrawn and all public comments received
will be addressed in a subsequent final rule based on this proposed
rule. EPA will not institute a second comment period. Any parties
interested in commenting on this action should do so at this time.
Please note that if EPA receives adverse comment on an amendment,
paragraph, or section of this rule and if that provision may be severed
from the remainder of the rule, EPA may adopt as final those provisions
of the rule that are not the subject of an adverse comment. For
additional information, see the direct final rule which is located in
the Rules section of this Federal Register.

    Dated: May 19, 2006.
Norman Niedergang,
Acting Regional Administrator, Region 5.
[FR Doc. 06-5014 Filed 5-31-06; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 84, Number 32 (Friday, February 15, 2019)]
[Rules and Regulations]
[Pages 4318-4320]
[FR Doc No: 2019-02159]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2018-0581; Product Identifier 2018-NM-029-AD; Amendment
39-19547; AD 2019-01-08]
RIN 2120-AA64

Airworthiness Directives; The Boeing Company Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: We are adopting a new airworthiness directive (AD) for certain
The Boeing Company Model 777-200, -200LR, -300, and -300ER series
airplanes. This AD was prompted by a report that showed a non-
compliance exists on some in-service galley attendant seat fitting
installations. The non-compliance could result in flight attendant
seats failing in a high-G crash. This AD requires modifications for
galley mounted seat fittings. We are issuing this AD to address the
unsafe condition on these products.

DATES: This AD is effective March 22, 2019.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of March 22,
2019.

ADDRESSES: For service information identified in this final rule,
contact Boeing Commercial Airplanes, Attention: Contractual & Data
Services (C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA
90740-5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com. You may view this service information at the
FAA, Transport Standards Branch, 2200 South 216th St., Des Moines, WA.
For information on the availability of this material at the FAA, call
206-231-3195. It is also available on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0581.

Examining the AD Docket

    You may examine the AD docket on the internet at http://www.regulations.gov by searching for and locating Docket No. FAA-2018-
0581; 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 final rule, the regulatory evaluation, any comments received, and
other information. The address for Docket Operations (phone: 800-647-
5527) is U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue SE,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Allison Buss, Aerospace Engineer,
Cabin Safety and Environmental Systems Section, FAA, Seattle ACO
Branch, 2200 South 216th St., Des Moines, WA 98198; phone and fax: 206-
231-3564; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 by adding an AD that would apply to certain The Boeing Company
Model 777-200, -200LR, -300, and -300ER series airplanes. The NPRM
published in the Federal Register on July 6, 2018 (83 FR 31509). The
NPRM was prompted by a report that showed a non-compliance exists on
some in-service galley attendant seat fitting installations. The NPRM
proposed to require modifications for galley mounted seat fittings.
    We are issuing this AD to address non-compliant flight attendant
seats, which could fail in a high-G crash and result in potential
injury to flight attendants and consequent inability of the flight
attendants to assist with passenger evacuation in a timely manner.

Comments

    We gave the public the opportunity to participate in developing
this final rule. The following presents the comments received on the
NPRM and the FAA's response to each comment.

Support for the NPRM

    Boeing indicated its support for the NPRM.

Request To Exclude Airplanes Without Affected Galleys

    United Airlines recommended adding a statement to explain that if a
reconfigured airplane's affected galley has been removed or replaced,
and the associated manuals have been updated, then that airplane would
not be affected by the AD.
    We do not agree to add the statement. This AD applies to each
airplane identified in the Effectivity section of Boeing Special
Attention Service Bulletin 777-25-0649, Revision 1, dated October 6,
2017. However, for airplanes that have been modified, repaired, or
altered so that accomplishment of that service information is affected,
then under the provisions of paragraph (h) of this AD, we will consider
requests for approval of an alternative method of compliance (AMOC). We
have not changed this AD in this regard.

Request To Include Updated Service Information

    Gary Chan, a private citizen, requested that the FAA review the
expected revision of Boeing Special Attention Service Bulletin 777-25-
0649, Revision 1, dated October 6, 2017. The commenter noted that
Zodiac Aerospace Service Bulletin 1016G-25-34, referenced in that
Boeing service information, has been revised and it is expected that
the Boeing service information will be updated accordingly. We infer
that the commenter is also requesting that the FAA revise the NPRM to
reference the updated service information.
    We do not agree. We may not refer to any document that does not yet
exist. In general terms, we are required by Office of the Federal
Register (OFR) regulations for approval of materials ``incorporated by
reference,'' as specified in 1 CFR 51.1(f), to either publish the
service document contents as part of the actual AD language; or submit
the service document to the OFR for approval as ``referenced''
material, in which case we may only refer to such material in the text
of an AD. The AD may refer to the service document only if the OFR
approved it for ``incorporation by reference.'' See 1 CFR part 51. We
do not consider that delaying this action until release of the revised
Boeing service information is warranted, since sufficient service
information exists. However, under the provisions of paragraph (h) of
this AD, we will consider requests for approval to use revised service
information if sufficient data are submitted to substantiate that the
change would provide an acceptable level of safety. We have not changed
the AD in this regard.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
this final rule as proposed, except for minor editorial changes. We
have determined that these minor changes:
     Are consistent with the intent that was proposed in the
NPRM for addressing the unsafe condition; and
     Do not add any additional burden upon the public than was
already proposed in the NPRM.

Related Service Information Under 1 CFR Part 51

    We reviewed Boeing Special Attention Service Bulletin 777-25-0649,
Revision 1, dated October 6, 2017. This service information describes
procedures for modifications for galley mounted seat fittings. This
service information 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.

Costs of Compliance

    We estimate that this AD affects 50 airplanes of U.S. registry. We
estimate the following costs to comply with this AD:

                                      Estimated Costs for Required Actions
----------------------------------------------------------------------------------------------------------------
                                                                                Cost per      Cost on U.S.
                Action                         Labor cost           Parts cost        product        operators
----------------------------------------------------------------------------------------------------------------
Modification..........................  7 work-hours x $85 per                $0            $595         $29,750
                                         hour = $595.
----------------------------------------------------------------------------------------------------------------

    According to the manufacturer, some or all of the costs of this AD
may be covered under warranty, thereby reducing the cost impact on
affected individuals. We do not control warranty coverage for affected
individuals. As a result, we have included all known costs in our cost
estimate.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. Subtitle VII: Aviation Programs,
describes in more detail the scope of the Agency's authority.
    We are issuing this rulemaking under the authority described in
Subtitle VII, Part A, Subpart III, Section 44701: ``General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.
    This AD is issued in accordance with authority delegated by the
Executive Director, Aircraft Certification Service, as authorized by
FAA Order 8000.51C. In accordance with that order, issuance of ADs is
normally a function of the Compliance and Airworthiness Division, but
during this transition period, the Executive Director has delegated the
authority to issue ADs applicable to transport category airplanes and
associated appliances to the Director of the System Oversight Division.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979),
    (3) Will not affect intrastate aviation in Alaska, and
    (4) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.

List of Subjects in 14 CFR Part 39

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

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):

2019-01-08 The Boeing Company: Amendment 39-19547; Docket No. FAA-
2018-0581; Product Identifier 2018-NM-029-AD.

(a) Effective Date

    This AD is effective March 22, 2019.

(b) Affected ADs

    None.

(c) Applicability

    This AD applies to The Boeing Company Model 777-200, -200LR, -
300, and -300ER series airplanes, certificated in any category, as
identified in Boeing Special Attention Service Bulletin 777-25-0649,
Revision 1, dated October 6, 2017.

(d) Subject

    Air Transport Association (ATA) of America Code 25, Equipment/
furnishings.

(e) Unsafe Condition

    This AD was prompted by a report that showed a non-compliance
exists on some in-service galley attendant seat fitting
installations. We are issuing this AD to address non-compliant
flight attendant seats, which could fail in a high-G crash and
result in potential injury to flight attendants and consequent
inability of the flight attendants to assist with passenger
evacuation in a timely manner.

(f) Compliance

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

(g) Required Actions

    Within 6 years after the effective date of this AD, do all
applicable actions identified as ``RC'' (required for compliance)
in, and in accordance with, the Accomplishment Instructions of
Boeing Special Attention Service Bulletin 777-25-0649, Revision 1,
dated October 6, 2017.

(h) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Seattle ACO 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
manager of the certification office, send it to the attention of the
person identified in paragraph (i) of this AD. Information may be
emailed to<EMAIL_ADDRESS>    (2) Before using any approved AMOC, notify your appropriate
principal inspector, or lacking a principal inspector, the manager
of the local flight standards district office/certificate holding
district office.
    (3) An AMOC that provides an acceptable level of safety may be
used for any repair, modification, or alteration required by this AD
if it is approved by the Boeing Commercial Airplanes Organization
Designation Authorization (ODA) that has been authorized by the
Manager, Seattle ACO Branch, FAA, to make those findings. To be
approved, the repair method, modification deviation, or alteration
deviation must meet the certification basis of the airplane, and the
approval must specifically refer to this AD.
    (4) For service information that contains steps that are labeled
as RC, the provisions of paragraphs (h)(4)(i) and (h)(4)(ii) of this
AD apply.
    (i) The steps labeled as RC, including substeps under an RC step
and any figures identified in an RC step, must be done to comply
with the AD. If a step or substep is labeled ``RC Exempt,'' then the
RC requirement is removed from that step or substep. An AMOC is
required for any deviations to RC steps, including substeps and
identified figures.
    (ii) Steps not labeled 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 RC
steps, including substeps and identified figures, can still be done
as specified, and the airplane can be put back in an airworthy
condition.

(i) Related Information

    For more information about this AD, contact Allison Buss,
Aerospace Engineer, Cabin Safety and Environmental Systems Section,
FAA, Seattle ACO Branch, 2200 South 216th St., Des Moines, WA 98198;
phone and fax:<PHONE_NUMBER>; email<EMAIL_ADDRESS>
(j) 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 the AD specifies otherwise.
    (i) Boeing Special Attention Service Bulletin 777-25-0649,
Revision 1, dated October 6, 2017.
    (ii) [Reserved]
    (3) For service information identified in this AD, contact
Boeing Commercial Airplanes, Attention: Contractual & Data Services
(C&DS), 2600 Westminster Blvd., MC 110-SK57, Seal Beach, CA 90740-
5600; telephone<PHONE_NUMBER>; internet https://www.myboeingfleet.com.
    (4) You may view this service information at the FAA, Transport
Standards Branch, 2200 South 216th St., Des Moines, WA. For
information on the availability of this material at the FAA, call
206-231-3195.
    (5) You may view this service information that is incorporated
by reference at the National Archives and Records Administration
(NARA). For information on the availability of this material at
NARA, call<PHONE_NUMBER>, or go to: http://www.archives.gov/federal-register/cfr/ibr-locations.html.

    Issued in Des Moines, Washington, on January 28, 2019.
Michael Kaszycki,
Acting Director, System Oversight Division, Aircraft Certification
Service.
[FR Doc. 2019-02159 Filed 2-14-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53271-53273]
[FR Doc No: 2018-22953]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0143]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Foreign Supplier Verification Programs for Food
Importers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on the information collection requirements
associated with our Foreign Supplier Verification Programs (FSVP) for
Food Importers.

DATES: Submit either electronic or written comments on the collection
of information by December 21, 2018.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before December 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 21, 2018. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2011-N-0143 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Foreign Supplier Verification
Programs for Food Importers.'' Received comments, those filed in a
timely manner (see ADDRESSES), 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.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined

in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests
or requirements that members of the public submit reports, keep
records, or provide information to a third party. Section 3506(c)(2)(A)
of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to
provide a 60-day notice in the Federal Register concerning each
proposed collection of information, including each proposed extension
of an existing collection of information, before submitting the
collection to OMB for approval. To comply with this requirement, FDA is
publishing notice of the proposed collection of information set forth
in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Foreign Supplier Verification Programs (FSVP) for Food Importers

OMB Control Number 0910-0752--Extension

    This information collection supports FDA regulations at 21 CFR part
1, subpart L--Foreign Supplier Verification Programs for Food
Importers, as well as associated guidance. As amended by the FDA Food
Safety Modernization Act (FSMA) (Pub. L. 111-353), the Federal Food,
Drug, and Cosmetic Act (FD&C Act) enables the Agency to better protect
the public health by helping to ensure the safety and security of the
food supply. The regulations are intended to help ensure that food
imported into the United States is produced in compliance with specific
processes and procedures, including reasonably appropriate risk-based
preventive controls. The regulations establish that importers of foods
must develop, maintain, and follow an FSVP that provides adequate
assurances that a foreign supplier is producing the food in compliance
with processes and procedures that provide at least the same level of
public health protection as those required under section 418 of the
FD&C Act (21 U.S.C. 350g) (regarding hazard analysis and risk-based
preventive controls for certain foods) or 419 (21 U.S.C. 350h)
(regarding standards for produce safety), if either is applicable, and
the implementing regulations, and is producing the food in compliance
with sections 402 (21 U.S.C. 342) (regarding adulteration) and 403(w)
(21 U.S.C. 343(w)) (if applicable) (regarding misbranding with respect
to labeling for the presence of major food allergens) of the FD&C Act.
The regulations also provide for certain exemptions.
    To assist respondents with the requirements we have developed
Agency guidance, which is available at: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm253380.htm.
    We estimate the burden of the information collection is as follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
                21 CFR section                    Number of     responses per   Total annual          Average burden per response           Total hours
                                                 respondents     respondent       responses
--------------------------------------------------------------------------------------------------------------------------------------------------------
Exemption for food for research 1.501(c).....          36,360              40       1,454,400  0.083 (5 minutes)........................         120,715
DUNS number for filing with U.S. Customs and           56,800             157       8,917,600  0.02 (1.2 minutes).......................         178,352
 Border Protection 1.509(c), 1.511(c),
 1.512(b)(2).
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................         299,067
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
   Information collection activity; 21 CFR        Number of      records per    Total annual       Average  burden per  recordkeeping       Total hours
                   section                      recordkeepers   recordkeeper       records
--------------------------------------------------------------------------------------------------------------------------------------------------------
Controls for low-acid canned foods; 1.502(b).           2,443               4           9,772  1........................................           9,772
FSVP Recordkeeping, including hazard
 determination, written procedures,
 reevaluation; audits; and corrective
 actions:
    Determine and document hazards; 1.504(a).          11,701               1          11,701  3.5......................................          40,954
    Review hazard analysis; 1.504(d).........          11,701               7          81,907  0.33 (20 minutes)........................          27,029
    Evaluation of food and foreign supplier;           11,701               1          11,701  4........................................          46,804
     1.505(a)(2), 1.511(c)(1).
    Approval of suppliers; 1.505(b),                    8,191               1           8,191  12.......................................          98,292
     1.512(c)(1)(iii).
    Reevaluation of food and foreign                   11,701             365       4,270,865  0.25 (15 minutes)........................       1,067,716
     supplier; 1.505(c), 1.512(c)(1)(ii)(A).
    Confirm or change requirements of foreign           2,340               1           2,340  2........................................           4,680
     supplier verification activity;
     1.505(c), 1.512(c)(1)(ii)(A).
    Review of other entities assessments;               3,510               1           3,510  1.2......................................           4,212
     1.505(d), 1.512(c)(1)(iii).
    Written procedures for use of approved             11,701               1          11,701  8........................................          93,608
     foreign suppliers; 1.506(a)(1),
     1.511(c)(2), 1.512(c)(3)(i).
    Review of written procedures;                      11,701               1          11,701  1........................................          11,701
     1.506(a)(2), 1.511(c)(2)(ii),
     1.512(c)(3)(ii).

    Written procedures for conducting                  11,701               1          11,701  2........................................          23,402
     verification activities; 1.506(b),
     1.511(c)(3).
    Determination and documentation of                 11,701               4          46,804  3.25.....................................         152,113
     appropriate supplier verification
     activities; 1.506(d)(1)-(2),
     1.511(c)(5)(i).
    Review of appropriate supplier                     11,701               2          23,402  0.33 (20 minutes)........................           7,723
     verification activities determined by
     another entity; 1.506(d)(3),
     1.511(c)(5)(iii).
    Conduct/review audits; 1.506(e)(1)(i),             11,701               2          23,402  3........................................          70,206
     1.511(c)(4)(ii)(A).
    Conduct periodic sampling/testing;                 11,701               2          23,402  1........................................          23,402
     1.506(e)(1)(ii), 1.511(c)(4)(ii)(B).
    Review records; 1.506(e)(1)(iii),                  11,701               2          23,402  1.6......................................          37,443
     1.511(c)(4)(ii)(C).
    Document your review of supplier                   11,701               6          70,206  0.25 (15 minutes)........................          17,552
     verification activity records;
     1.506(e)(3), 1.511(c)(4)(iii).
    1.507(a)(1)..............................          11,701            3.17          37,092  1.25.....................................          46,365
    Written assurances; 1.507(a)(2),                   11,701            8.72         102,038  0.50 (30 minutes)........................          51,019
     1.507(a)(3), and 1.507(a)(4).
    Disclosures that accompany assurances;            102,038               1         102,038  0.50 (30 minutes)........................          51,019
     1.507(a)(2), 1.507(a)(3), and
     1.507(a)(4).
    Document assurances from customers;                36,522             2.8         102,262  0.25 (15 minutes)........................          25,566
     1.507(c).
    Document corrective actions; 1.508(a) and           2,340               1           2,340  2........................................           4,680
     1.512(b)(4).
    Investigate and determine FSVP adequacy;            2,340               1           2,340  5........................................          11,700
     1.508(b), 1.511(c)(1).
                                              ----------------------------------------------------------------------------------------------------------
        Subtotal for FSVP Recordkeeping        ..............  ..............       4,984,046  .........................................       1,917,186
         Itemized Above.
                                              ==========================================================================================================
    Written assurances for food produced               11,701            2.88          33,699  2.25.....................................          75,823
     under dietary supplement current good
     manufacturing practices; 1.511(b).
    Document very small importer/certain               50,450               1          50,450  1........................................          50,450
     small foreign supplier status;
     1.512(b)(1).
Written assurances associated with very small          50,450             2.8         141,260  2.25.....................................         317,835
 importer/certain small foreign supplier
 1.512(b)(3).
                                              ----------------------------------------------------------------------------------------------------------
    Total....................................  ..............  ..............  ..............  .........................................       2,361,294
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with the information collection.

    We are retaining the currently approved burden estimates. The FSVP
requirements became effective May 30, 2017, and we continue to evaluate
associated burden.

    Dated: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22953 Filed 10-19-18; 8:45 am]
 BILLING CODE 4164-01-P


			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on March 8, 2005

NOTICE OF ACTION TAKEN -- DOCKET OST-2001-8859

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant:  PrivatAir S.A. 					Date Filed:  February 1, 2005

Relief requested:  Renew exemption from 49 U.S.C. § 41301 to conduct
charter foreign air transportation of persons, property, and mail
between any point or points in Switzerland and any point or points in
the United States, either directly or via intermediate points in other
countries, with or without stopovers, and beyond, pursuant to the
U.S.-Switzerland Air Transport Agreement; and other charters pursuant to
14 CFR 212 of the Department’s regulations.

If renewal, date and citation of last action:  February 20, 2003, in
this docket

Applicant representative:  Malcolm Benge<PHONE_NUMBER>

DOT Analyst:  Shelita A. Smith<PHONE_NUMBER>

Responsive pleadings:  None

DISPOSITION

Action:  Approved 							Action date:  March 8, 2005

Effective dates of authority granted:  March 8, 2005 – March 8, 2007

Basis for approval (bilateral agreement/reciprocity): The authority is
provided for in the U.S.-Switzerland Air Transport Agreement.

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

    X   Standard exemption conditions (attached)               Foreign
air carrier permit conditions (Order         )

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:  Paul L. Gretch, Director

		   Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant is qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied

all requests in the referenced Docket.  We may amend, modify, or revoke
the authority granted in this Notice at any time without hearing at our
discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.

05/2004


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request USEPA/ Office of Enforcement and Compliance Assurance 2. OMB control number b. G None a. 2060 0073 __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes GX No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS for Flexible Vinyl and Urethane Coating and Printing ( 40 CFR part 60, subpart FFF)

8. Agency form number( s) ( If applicable) EPA ICR Number 1157.07 9. Keywords Vinyl, Urethane, Coating and Printing, NSPS 10. Abstract This standard applies to each rotogravure printing line used to print or coat flexible vinyl or urethane products, for which construction, modification or reconstruction commenced after January 18, 1983. Volatile organic compounds are the pollutants regulated under this subpart. The standards restrict the use of inks to those with a weighted average VOC content of less than 1.0 kilogram VOC per kilogram of ink solids, unless the source can otherwise reduce emissions by 85 percent.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 20 b. Total annual responses 41 1. Percentage of these responses collected electronically 20 _________ % c. Total hours requested 593 d. Current OMB inventory __ 515 _____ e. Difference 78 f. Explanation of difference 1. Program Change 0 2. Adjustment 78 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars) a. Total annualized capital/ startup costs 7 b. Total annual costs ( O& M) 54 c. Total annualized cost requested 61 d. Current OMB inventory 52 e. Difference 9 f. Explanation of difference 1. Program change 0 2. Adjustment 9 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. Application for benefits e. Program planning or management b. Program evaluation f. Research c. General purpose statistics g. P Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. X Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. X Semiannually 6. Q Annually 7. Q Biannually 8. X Other ( describe) initially 17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Learia A. Williams Phone: ( 202) 564 4113 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3):

( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

Signature of Program Official Michael S. Alushin, Director Compliance Assessment and Media Programs Division Office of Compliance Office of Enforcement and Compliance Assurance Date Signature of Senior Official or designee Doreen Sterling, Acting Director Collection Strategies Division Office of Environmental Information Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C. § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of:

"( i) the reasons the information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number."

OMB 83 I ( Instructions) 10/ 95


[Federal Register Volume 76, Number 222 (Thursday, November 17, 2011)]
[Notices]
[Page 71348]
[FR Doc No: 2011-29703]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-N-0802]

Role of Naloxone in Opioid Overdose Fatality Prevention; Public
Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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

    The Food and Drug Administration (FDA), Center for Drug Evaluation
and Research (CDER), in collaboration with the Office of the Assistant
Secretary for Health, National Institutes of Drug Abuse, and the
Centers for Disease Control and Prevention, is announcing a scientific
workshop to initiate a public discussion about the potential value of
making naloxone more widely available outside of conventional medical
settings to reduce the incidence of opioid overdose fatalities.
Academia, government, industry experts, and patient advocates will be
assembled to discuss which populations are at risk for opioid overdose
and how public health groups are working together to curb the abuse of
opioids. We will also seek to identify potential health concerns,
social concerns, legal concerns, regulatory issues, and future research
needs related to making naloxone more widely available.
    Date and Time: The public workshop will be held on April 12, 2012,
from 8:30 a.m. to 5:30 p.m.
    Location: The public workshop will be held at FDA White Oak Campus,
10903 New Hampshire Ave., Building 31 Conference Center, the Great Room
(rm 1503), Silver Spring, MD 20993-0002.
    Contact Person: Mary Gross, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Silver Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
or Matthew Petcovic, 10903 New Hampshire Ave., Silver Spring, MD 20993-
0002,<PHONE_NUMBER><EMAIL_ADDRESS>    Registration: If you wish to attend the public workshop or provide
testimony during the open public hearing, please email your
registration to<EMAIL_ADDRESS>by March 28, 2012.
Those without email access may register by contacting one of the
persons listed in the Contact Person section of this document. Please
provide complete contact information for each attendee; including name,
title, affiliation, address, email address, and telephone number.
Registration is free and will be on a first-come, first-served basis.
Early registration is recommended because seating is limited.
Registrants will receive confirmation once they have been accepted for
the workshop. Onsite registration on the day of the public workshop
will be based on space availability. If registration reaches maximum
capacity, FDA will post a notice closing meeting registration for the
workshop at: http://www.fda.gov/Drugs/NewsEvents/ucm277119.htm.
    An open public hearing will be held between 2:45 p.m. and 3:45 p.m.
on April 12, 2012, during which speaker testimony will be accepted. We
will try to accommodate all persons who wish to testify; however, the
duration of each speaker's testimony during this open public hearing
may be limited by time constraints. Those wishing to participate in the
open public hearing should limit their remarks to a discussion of the
advantages and/or disadvantages to making naloxone more easily
accessible to patients outside of conventional medical settings.
    Comments: Submit either electronic or written comments by June 12,
2012. Submit electronic comments to http://www.regulations.gov. Submit
written comments to the Division of Dockets Management (HFA 305), Food
and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD
20852. It is necessary to send only one set of comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
    If you need special accommodations due to a disability, contact
Mary Gross or Matt Petcovic (see Contact Person) at least 7 days in
advance of the meeting.

SUPPLEMENTARY INFORMATION:

I. Introduction

    The number of prescriptions filled for opioid pain relievers has
increased dramatically in recent years. Nearly 257 million
prescriptions for opioid drugs were written in the United States in
2009 alone and the increased availability to prescription opioid drugs
appear to be contributing significantly to abuse and the potential for
overdose in the United States. In the United States, mortality rates
closely correlate with opioid sales. In 2007, approximately 36,034
people died from unintentional overdoses. At least 14,459 of these
deaths involved prescription opioid analgesics. Moreover, according to
the Substance Abuse and Mental Health Services Administration, the
number of Americans in 2009 aged 12 and older currently abusing pain
relievers has increased by 20 percent since 2002. Naloxone, a mu-opioid
antagonist, is an injectable medicine that can rapidly reverse the
overdose of either prescription (e.g., OxyContin) or illicit (e.g.,
heroin) opioids. It is currently the standard treatment for those who
overdose on opioid drugs, but is most commonly used only by trained
medical personnel in emergency departments and on ambulances. The
purpose of this public workshop is to discuss the issues around making
naloxone more widely available. This includes work to expand its use
through the development of novel formulations as well as work to
potentially support its use by individuals other than the trained
medical personnel currently authorized to use it.
    FDA will post the agenda and additional workshop background
material approximately 5 days before the workshop at: http://www.fda.gov/Drugs/NewsEvents/ucm277119.htm.

II. Transcripts

    Please be advised that approximately 30 days after the public
workshop, a transcript will be made available. It will be accessible at
http://www.regulations.gov, and may be viewed at the Division of
Dockets Management (see Comments). A transcript will also be available
in either hardcopy or on CD-ROM, after submission of a Freedom of
Information request. Written requests are to be sent to Division of
Freedom of Information (ELEM-1029), Food and Drug Administration, 12420
Parklawn Dr., Element Bldg., Rockville MD 20857.

    Dated: November 10, 2011.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2011-29703 Filed 11-16-11; 8:45 am]
BILLING CODE 4160-01-P