[Federal Register Volume 86, Number 145 (Monday, August 2, 2021)]
[Notices]
[Pages 41500-41502]
[FR Doc No: 2021-16437]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2021-0002; Internal Agency Docket No. FEMA-B-2153]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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SUMMARY: This notice lists communities where the addition or
modification of Base Flood Elevations (BFEs), base flood depths,
Special Flood Hazard Area (SFHA) boundaries or zone designations, or
the regulatory floodway (hereinafter referred to as flood hazard
determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and
where applicable, in the supporting Flood Insurance Study (FIS)
reports, prepared by the Federal Emergency Management Agency (FEMA) for
each community, is appropriate because of new scientific or technical
data. The FIRM, and where applicable, portions of the FIS report, have
been revised to reflect these flood hazard determinations through
issuance of a Letter of Map Revision (LOMR), in accordance with Federal
Regulations. The LOMR will be used by insurance agents and others to
calculate appropriate flood insurance premium rates for new buildings
and the contents of those buildings. For rating purposes, the currently
effective community number is shown in the table below and must be used
for all new policies and renewals.

DATES: These flood hazard determinations will be finalized on the dates
listed in the table below and revise the FIRM panels and FIS report in
effect prior to this determination for the listed communities.
    From the date of the second publication of notification of these
changes in a newspaper of local circulation, any person has 90 days in
which to request through the community that the Deputy Associate
Administrator for Insurance and Mitigation reconsider the changes. The
flood hazard determination information may be changed during the 90-day
period.

ADDRESSES: The affected communities are listed in the table below.
Revised flood hazard information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.
    Submit comments and/or appeals to the Chief Executive Officer of
the community as listed in the table below.

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
<EMAIL_ADDRESS>or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The specific flood hazard determinations are
not described for each community in this notice. However, the online
location and local community map repository address where the flood
hazard determination information is available for inspection is
provided.
    Any request for reconsideration of flood hazard determinations must
be submitted to the Chief Executive Officer of the community as listed
in the table below.
    The modifications are made pursuant to section 201 of the Flood
Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance
with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq.,
and with 44 CFR part 65.
    The FIRM and FIS report are the basis of the floodplain management
measures that the community is required either to adopt or to show
evidence of having in effect in order to qualify or remain qualified
for participation in the National Flood Insurance Program (NFIP).
    These flood hazard determinations, together with the floodplain
management criteria required by 44 CFR 60.3, are the minimum that are
required. They should not be construed to mean that the community must
change any existing ordinances that are more stringent in their
floodplain management requirements. The community may at any time enact
stricter requirements of its own or pursuant to policies established by
other Federal, State, or regional entities. The flood hazard
determinations are in accordance with 44 CFR 65.4.
    The affected communities are listed in the following table. Flood
hazard determination information for each community is available for
inspection at both the online location and the respective community map
repository address listed in the table below. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

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                                     Location and  case     Chief executive officer  of                                   Online location of letter  of map                           Community
         State and county                   No.                      community              Community map  repository                 revision                Date of modification       No.
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Colorado:
    Adams........................  Unincorporated areas   The Honorable Eva J. Henry,     Adams County Community and     https://msc.fema.gov/portal/        Oct. 28, 2021.........       080001
                                    of Adams County (20-   Chair, Adams County Board of    Economic Development, 4430     advanceSearch.
                                    08-0723P).             Commissioners, 4430 South       Adams County Parkway, 1st
                                                           Adams County Parkway, Suite     Floor, Suite W2000,
                                                           C5000A, Brighton, CO 80601.     Brighton, CO 80601.
    Boulder......................  City of Longmont (20-  The Honorable Brian Bagley,     Development Services Center,   https://msc.fema.gov/portal/        Oct. 25, 2021.........       080027
                                    08-0847P).             Mayor, City of Longmont, 350    385 Kimbark Street,            advanceSearch.
                                                           Kimbark Street, Longmont, CO    Longmont, CO 80501.
                                                           80501.

    El Paso......................  City of Colorado       The Honorable John Suthers,     Pikes Peak Regional            https://msc.fema.gov/portal/        Oct. 27, 2021.........       080060
                                    Springs (20-08-        Mayor, City of Colorado         Development Center, 2880       advanceSearch.
                                    0822P).                Springs, 30 South Nevada        International Circle,
                                                           Avenue, Suite 601, Colorado     Colorado Springs, CO 80910.
                                                           Springs, CO 80903.
    Weld.........................  Town of Windsor (21-   The Honorable Paul Rennemeyer,  Town Hall, 301 Walnut Street,  https://msc.fema.gov/portal/        Nov. 1, 2021..........       080264
                                    08-0116P).             Mayor, Town of Windsor, 301     Windsor, CO 80550.             advanceSearch.
                                                           Walnut Street, Windsor, CO
                                                           80550.
    Weld.........................  Unincorporated areas   The Honorable Steve Moreno,     Weld County Administration     https://msc.fema.gov/portal/        Nov. 1, 2021..........       080266
                                    of Weld County (21-    Chairman, Weld County Board     Building, 1150 O Street,       advanceSearch.
                                    08-0116P).             of Commissioners, P.O. Box      Greeley, CO 80631.
                                                           758, Greeley, CO 80631.
Florida:
    Alachua......................  Unincorporated areas   Ms. Michelle L. Lieberman,      Alachua County Public Works    https://msc.fema.gov/portal/        Oct. 20, 2021.........       120001
                                    of Alachua County      Alachua County Manager, 12      Department, 5620 Northwest     advanceSearch.
                                    (21-04-0749P).         Southeast 1st Street,           120th Lane, Gainesville, FL
                                                           Gainesville, FL 32601.          32653.
    Lee..........................  Unincorporated areas   Mr. Roger Desjarlais, Lee       Lee County Building            https://msc.fema.gov/portal/        Oct. 20, 2021.........       125124
                                    of Lee County (21-04-  County Manager, 2115 2nd        Department, 1500 Monroe        advanceSearch.
                                    1477P).                Street, Fort Myers, FL 33901.   Street, Fort Myers, FL
                                                                                33901.
    Lee..........................  Village of Estero (21- Mr. Steven R. Sarkozy, Village  Village Hall, 9401 Corkscrew   https://msc.fema.gov/portal/        Oct. 20, 2021.........       120260
                                    04-1477P).             of Estero Manager, 9401         Palms Circle, Estero, FL       advanceSearch.
                                                           Corkscrew Palms Circle,         33928.
                                                           Estero, FL 33928.
    Monroe.......................  Village of Islamorada  The Honorable Buddy Pinder,     Building Department, 86800     https://msc.fema.gov/portal/        Oct. 18, 2021.........       120424
                                    (21-04-2470P).         Mayor, Village of Islamorada,   Overseas Highway,              advanceSearch.
                                                           86800 Overseas Highway,         Islamorada, FL 33036.
                                                           Islamorada, FL 33036.
    Palm Beach...................  Unincorporated areas   Ms. Verdenia C. Baker, Palm     Palm Beach County Planning,    https://msc.fema.gov/portal/        Oct. 18, 2021.........       120192
                                    of Palm Beach County   Beach County Administrator,     Zoning and Building            advanceSearch.
                                    (20-04-0988P).         301 North Olive Avenue, Suite   Department, 2300 North Jog
                                                           1101, West Palm Beach, FL       Road, Room 1E-17, West Palm
                                                           33401.                          Beach, FL 33411.
    Sarasota.....................  Unincorporated areas   The Honorable Alan Maio,        Sarasota County Planning and   https://msc.fema.gov/portal/        Oct. 13, 2021.........       125144
                                    of Sarasota County     Chairman, Sarasota County       Development Services           advanceSearch.
                                    (21-04-1410P).         Board of Commissioners, 1660    Department, 1001 Sarasota
                                                           Ringling Boulevard, Sarasota,   Center Boulevard, Sarasota,
                                                           FL 34236.                       FL 34240.
    Sumter.......................  City of Wildwood (20-  The Honorable Ed Wolf, Mayor,   Public Works Department, 743   https://msc.fema.gov/portal/        Oct. 15, 2021.........       120299
                                    04-3503P).             City of Wildwood, 100 North     Huey Street, Wildwood, FL      advanceSearch.
                                                           Main Street, Wildwood, FL       34785.
                                                           34785.
    Sumter.......................  City of Wildwood (20-  The Honorable Ed Wolf, Mayor,   Public Works Department, 743   https://msc.fema.gov/portal/        Oct. 15, 2021.........       120299
                                    04-3653P).             City of Wildwood, 100 North     Huey Street, Wildwood, FL      advanceSearch.
                                                           Main Street, Wildwood, FL       34785.
                                                           34785.
    Sumter.......................  Unincorporated areas   The Honorable Garry Breeden,    Sumter County Planning         https://msc.fema.gov/portal/        Oct. 15, 2021.........       120296
                                    of Sumter County (20-  Chairman, Sumter County Board   Department, 7375 Powell        advanceSearch.
                                    04-3503P).             of Commissioners, 7375 Powell   Road, Suite 115, Wildwood,
                                                           Road, Wildwood, FL 34785.       FL 34785.
    Sumter.......................  Unincorporated areas   The Honorable Garry Breeden,    Sumter County Planning         https://msc.fema.gov/portal/        Oct. 15, 2021.........       120296
                                    of Sumter County (20-  Chairman, Sumter County Board   Department, 7375 Powell        advanceSearch.
                                    04-3653P).             of Commissioners, 7375 Powell   Road, Suite 115, Wildwood,
                                                           Road, Wildwood, FL 34785.       FL 34785.
Kentucky: Hardin.................  City of Vine Grove     The Honorable Pam Ogden,        City Hall, 300 West Main       https://msc.fema.gov/portal/        Oct. 25, 2021.........       210096
                                    (21-04-0296P).         Mayor, City of Vine Grove,      Street, Vine Grove, KY         advanceSearch.
                                                           300 West Main Street, Vine      40175.
                                                           Grove, KY 40175.
Montana:
    Gallatin.....................  City of Bozeman (20-   Mr. Jeff Mihelich, City of      City Hall, 20 East Olive       https://msc.fema.gov/portal/        Oct. 6, 2021..........       300028
                                    08-0733P).             Bozeman Manager, 121 North      Street, Bozeman, MT 59715.     advanceSearch.
                                                           Rouse Avenue, Bozeman, MT
                                                           59715.

    Gallatin.....................  Unincorporated areas   The Honorable Scott             Gallatin County Department of  https://msc.fema.gov/portal/        Oct. 6, 2021..........       300027
                                    of Gallatin County     MacFarlane, Chairman,           Planning and Community         advanceSearch.
                                    (20-08-0733P).         Gallatin County Commission,     Development, 311 West Main
                                                           311 West Main Street, Room      Street, Room 108, Bozeman,
                                                           306, Bozeman, MT 59715.         MT 59715.
South Carolina: Horry............  City of North Myrtle   Mr. Michael Mahaney, Manager,   Planning and Development       https://msc.fema.gov/portal/        Oct. 27, 2021.........       450110
                                    Beach (21-04-0914P).   City of North Myrtle Beach,     Department, 1018 2nd Avenue    advanceSearch.
                                                           1018 2nd Avenue South, North    South, North Myrtle Beach,
                                                           Myrtle Beach, SC 29582.         SC 29582.
Texas:
    Collin.......................  City of McKinney (21-  The Honorable George Fuller,    Engineering Department, 221    https://msc.fema.gov/portal/        Oct. 12, 2021.........       480135
                                    06-0619P).             Mayor, City of McKinney, P.O.   North Tennessee Street,        advanceSearch.
                                                           Box 517, McKinney, TX 75070.    McKinney, TX 75069.
    Collin.......................  Unincorporated areas   The Honorable Chris Hill,       Collin County Engineering      https://msc.fema.gov/portal/        Oct. 12, 2021.........       480130
                                    of Collin County (21-  Collin County Judge, 2300       Department, 4690 Community     advanceSearch.
                                    06-0619P).             Bloomdale Road, Suite 4192,     Avenue, Suite 200, McKinney,
                                                           McKinney, TX 75071.             TX 75071.
    Dallas.......................  City of Rowlett (21-   The Honorable TammyDana-        Community Development          https://msc.fema.gov/portal/        Oct. 15, 2021.........       480185
                                    06-0711P).             Bashian Mayor, City of          Department, 5702 Rowlett       advanceSearch.
                                                           Rowlett, 4000 Main Street,      Road, Rowlett, TX 75089.
                                                           Rowlett, TX 75088.
    El Paso......................  City of El Paso (21-   The Honorable Oscar Leeser,     Flood Mitigation and Land      https://msc.fema.gov/portal/        Oct. 8, 2021..........       480214
                                    06-0100P).             Mayor, City of El Paso, 300     Development Department, 801    advanceSearch.
                                                           North Campbell Street, El       Texas Avenue, El Paso, TX
                                                           Paso, TX 79901.                 79901.
    El Paso......................  City of Socorro (21-   The Honorable Ivy Avalos,       Planning and Zoning            https://msc.fema.gov/portal/        Oct. 8, 2021..........       481658
                                    06-0100P).             Mayor, City of Socorro, 124     Department, 860 North Rio      advanceSearch.
                                                           South Horizon Boulevard,        Vista Road, Socorro, TX
                                                           Socorro, TX 79927.              79927.
    Montgomery...................  Unincorporated areas   The Honorable Mark J. Keough,   Montgomery County              https://msc.fema.gov/portal/        Oct. 8, 2021..........       480483
                                    of Montgomery County   Montgomery County Judge, 501    Commissioners Office, 501      advanceSearch.
                                    (20-06-1594P).         North Thompson Street, Suite    North Thompson Street, Suite
                                                           401, Conroe, TX 77301.          103, Conroe, TX 77301.
    Rockwall.....................  City of Fate (21-06-   The Honorable David Billings,   Planning and Development       https://msc.fema.gov/portal/        Nov. 1, 2021..........       480544
                                    0525P).                Mayor, City of Fate, 1900       Department, 1900 C.D. Boren    advanceSearch.
                                                           C.D. Boren Parkway, Fate, TX    Parkway, Fate, TX 75087.
                                                           75087.
    Williamson...................  City of Georgetown     Mr. David Morgan, Manager,      Mapping and GIS Department,    https://msc.fema.gov/portal/        Oct. 14, 2021.........       480668
                                    (21-06-0115P).         City of Georgetown, P.O. Box    300-1 Industrial Avenue,       advanceSearch.
                                                           409, Georgetown, TX 78626.      Georgetown, TX 78626.
    Williamson...................  Unincorporated areas   The Honorable Bill Gravell,     Williamson County Engineering  https://msc.fema.gov/portal/        Oct. 14, 2021.........       481079
                                    of Williamson County   Jr., Williamson County Judge,   Department, 3151 Southeast     advanceSearch.
                                    (21-06-0115P).         710 South Main Street, Suite    Inner Loop, Georgetown, TX
                                                           101, Georgetown, TX 78626.      78626.
Utah: Washington                   City of Hurricane (20- The Honorable John W. Bramall,  Engineering Department, 147    https://msc.fema.gov/portal/        Oct. 25, 2021.........       490172
                                    08-1034P).             Mayor, City of Hurricane, 147   North 870 West, Hurricane,     advanceSearch.
                                                           North 870 West, Hurricane, UT   UT 84737.
                                                           84737.
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[FR Doc. 2021-16437 Filed 7-30-21; 8:45 am]
BILLING CODE 9110-12-P


XX.  Comments on Product Complaints (Final Subpart O)

A.  Organization of Final Subpart O

     In the 2003 CGMP Proposal, the requirements for consumer complaints
were set forth in § 111.95.  As shown in table 16, we are reorganizing
proposed § 111.95 into three provisions in a new subpart (Subpart O
– Product Complaints).  Table 16 lists the sections in final subpart O
and identifies the provisions that form the basis for the final rule.

Table 16. - Derivation of Sections in Final Subpart O

Final Rule	2003 CGMP Proposal

 § 111.553 What Are the Requirements Under this Subpart for Written
Procedures?	N/A

§ 111.560 What requirements Apply to the Review and Investigation of a
Product complaint? 	§ 111.95(a), (b), (c), and (d)

§ 111.570 Under this Subpart,
W慨⁴敒潣摲⁳畍瑳夠畯䴠歡湡敋灥ܿꂧㆠㄱ㤮⠵⥥
愠摮⠠⥦܇഍⹂†楈桧楬桧獴漠桃湡敧⁳潴琠敨倠潲
潰敳敒畱物浥湥獴映牯倠潲畤瑣䌠浯汰楡瑮൳⸱†敒
楶楳湯൳††吠敨映湩污爠汵㩥

●	Includes changes that reflect the final rule applies to persons who
manufacture, package, label, or hold dietary supplements unless subject
to an exclusion in § 111.1.

● 	Uses the term “product complaint” rather than “consumer
complaint,” and the definition of “product complaint” does not
include an explanation about the types of complaints that may or may not
be covered by the CGMP regulations.  The definition does, however,
include examples of product complaints.

2.  Changes After Considering Comments

††吠敨映湩污爠汵潭楤楦獥琠敨瀠潲散獳映牯栠湡
汤湩牰摯捵⁴潣灭慬湩獴愠⁳潦汬睯㩳

●	A qualified person investigates any product complaint that involves
a possible failure of a dietary supplement to meet any requirements of
part 111, without an intermediate step of having the quality control
unit first determine whether the complaint should be investigated;

●	The quality control unit reviews and approves all decisions made by
the qualified person about whether to investigate a product complaint
and the findings and follow-up action of any investigation performed
rather than conduct the investigation and follow up itself; and

●	The review and investigation of the product complaint extends to all
relevant batches and records, without identifying specific records, and
specific batches, that must be included in the review and investigation.

C.  General Comments on Proposed § 111.95

(Final Subpart O)

     (Comment 314) Some comments express general support for the
proposed procedures for consumer complaints.  Other comments request
proposed § 111.95 be deleted.  Most of these comments point out that
we had announced the development of CFSAN’s Adverse Event Reporting
System (CAERS) for reporting to FDA adverse events attributed to food
products and suggest that this new system would be the appropriate
mechanism for handling complaints about dietary supplements.

     (Response)  We disagree with these comments.  Because the problem
giving rise to the complaint may be associated with a failure in
manufacturing, packaging, labeling, or holding, it is CGMP for a firm
that receives a product complaint to review it and investigate, if
necessary, regardless of whether we are notified about the complaint.
An important goal of the firm’s review and investigation is to
determine whether there is a problem with the production and process
control system for the manufacture, packaging, labeling, or holding of
the dietary supplement.  That goal would not be achieved merely by
notifying us.  A firm subject to any of the requirements of this final
rule, whether such firm is a manufacturer, packager, labeler, or holder,
is responsible for the requirements in subpart O for a product complaint
it receives.

     (Comment 315)  Some comments assert that the proposed requirements
for consumer complaints do not go far enough and urge that any final
rule require any complaints that involve an adverse event be referred to
us.  The comments stress accurate reporting of adverse events is
essential to long-term evaluations of a product’s safety.

     (Response)  Mandatory reporting requirements to us regarding
adverse events related to dietary supplements are outside the scope of
this rulemaking.  This final rule addresses the internal processes and
controls that persons who manufacture, package, label, or hold dietary
supplements must follow.  As discussed in the preamble to the 2003 CGMP
Proposal (68 FR 12157 at 12217), however, we strongly recommend that
firms that receive such product complaints notify us about any illness
or injury, because, for example, we may have additional expertise or
data that may be helpful in investigating the complaint or determining
whether the problem applies to more than one product.  In light of the
requirement in the final rule to establish and follow written procedures
for handling product complaints, we encourage you to include our
recommendation in the written procedures that you develop for handling
product complaints (see discussion of final § 111.553 in this
section).

     (Comment 316) Some comments raise questions about who would be
subject to the proposed requirements regarding consumer complaints.
Some comments state the section should apply only to manufacturers of
dietary supplements, not to manufacturers of dietary ingredients.  Other
comments are concerned that distributors who merely put their label on
the finished product may be held responsible for keeping records of
adverse events caused by failures to follow CGMPs during the manufacture
of the supplements.

     (Response) The final rule only applies to persons who manufacture,
package, label, or hold a dietary supplement.  We discuss the scope of
this final rule in detail in section VI.

     In most cases, the person who receives a product complaint from a
consumer will be the manufacturer, packager, or distributor of the
dietary supplement.  A distributor (also a “holder” under this final
rule) who receives a product complaint must review and investigate that
complaint to determine whether the complaint relates to a failure of the
processes under the control of the distributor, such as conditions of
temperature, humidity, and light that could affect the identity, purity,
strength, or composition of the dietary supplement.  If the distributor
concludes the problem is unrelated to any process under the control of
the distributor, the distributor should contact the manufacturer.  Under
the final rule, any person in the manufacturing chain who receives a
product complaint - regardless of the source - must comply with the
requirements in subpart O.

     (Comment 317) One comment suggests proposed § 111.95, which
describes requirements for consumer complaints, could be combined with
proposed § 111.85 which describes requirements for returned dietary
supplements.

     (Response) We decline to adopt this suggestion.  In this final
rule, we are incorporating the requirements for returned dietary
supplements into a distinct subpart (final subpart N) that sets forth
requirements for returned dietary supplements. The procedures described
in final subpart O, which relate solely to the handling of product
complaints rather than returned, are quite different from those
described in final subpart N, which addresses the handling, review, and
possible reprocessing of returned product.

     (Comment 318) Some comments assert the proposed requirements for
complaints are different from those for food CGMPs.

     (Response) We are making no changes to the requirements after
considering these comments.  We responded to similar comments asserting
that certain aspects of the proposed regulations are different from
those for other food CGMP requirements in section V.

D.  What Are the Requirements under this Subpart

for Written Procedures?

(Final § 111.553)

     We received many comments which recommended written procedures for
various provisions.  We address the need for written procedures
generally in section IV.  We also respond to individual comments on
specific provisions in the same section.

Final § 111.553 requires that you establish and follow written
procedures to fulfill the requirements of subpart O.   Under final
111.570(b)(1) we require you to make and keep records of such
procedures.  Such records would be required to be made available to us
under the requirements in subpart P.

	We encourage you to include in your written procedures the
recommendation made in the 2003 CGMP Proposal for you to consult with a
health care provider if you receive complaints that involve serious
illness or injury and for you to notify us about complaints of illness
or injury associated with the quality of the dietary supplement.

E.  What Requirements Apply to the Review and Investigation of a Product
Complaint?

(Final § 111.560)

1.  Final § 111.560(a)(1)

     Final § 111.560(a)(1) requires a qualified person to review all
product complaints to determine whether the product complaint involves a
possible failure of a dietary supplement to meet any of its
specifications, or any other requirements of part 111, including those
specifications and other requirements that, if not met, may result in a
risk of illness or injury.  Final § 111.560(a)(1) derives from
proposed § 111.95(a).

     We did not receive comments specific to proposed § 111.95(a).

2.  Final § 111.560(a)(2), (b), and (c)

     Final § 111.560(a)(2) requires a qualified person to investigate
any product complaint that involves a possible failure of a dietary
supplement to meet any of its specifications, or any other requirements
of part 111, including those specifications and other requirements that,
if not met, may result in a risk of illness or injury.  Final
§ 111.560(b) requires that the quality control unit review and approve
decisions by the qualified person about whether or not to investigate a
product complaint and the findings and follow-up action of any
investigation performed.

     (Comment 319) Some comments characterize the requirements of
proposed § 111.95 as a confusing and difficult scheme to review,
investigate, and resolve customer complaints.  These comments state the
2003 CGMP Proposal would require extensive human resources,
recordkeeping, and decision-making.

     (Response)  We disagree that the 2003 CGMP Proposal would require
extensive human resources, recordkeeping, or decision making.  The
comments provided no rationale for such assertions.  The 2003 CGMP
Proposal sets forth basic steps, i.e., review, evaluation, and
follow-up, that one would need to take to appropriately address a
product complaint.  For those product complaints for which there is a
reasonable possibility of a relationship to an adverse event, the 2003
CGMP Proposal would require that an investigation be done by the quality
control unit because we believe such an event would need more careful
review and follow-up.

	To address the comments that found proposed § 111.90 confusing, we
have made the following changes in the final rule to simplify the
procedures for handling product complaints:

●	Replaced the proposed procedure in which a qualified person
determines whether a complaint should be investigated by the quality
control unit with a procedure in which a qualified person investigates
any product complaint that involves a possible failure of a dietary
supplement to meet any requirements of part 111.

●	Require an oversight function by the quality control unit for the
review and evaluation of product complaints, but not require that the
quality control unit do any investigations on its own.  This is
consistent with other changes that we are making in response to comments
that requested that the quality control unit focus on reviewing tasks
performed by others rather than on performing the tasks itself.

●	Refer to “any product complaint that involves a possible failure
of a dietary supplement to meet any of its specifications, or any other
requirements of this part [part 111], including those specifications and
other requirements that, if not met, may result in a risk of illness or
injury” rather than to “a reasonable possibility of a relationship
between the quality of a dietary supplement and an adverse event.”
This is consistent with changes that we are making to the definition of
the term “product complaint” in final § 111.3 (see section VI).

●	Continue to require that the review and investigation of the product
complaint extend to all relevant batches and records but simplify the
language of the requirement by removing the details – i.e., that the
investigation must include the batch records associated with the dietary
supplement involved in the consumer complaint and not specifying that
the investigation must extend to other batches of dietary supplement.
Rather, we require that the investigation must extend to all relevant
batches and records.

     The final rule provides firms flexibility on how to use its human
resources.  Nothing in subpart O would preclude a qualified person
within the quality control unit from actually reviewing product
complaints and conducting investigations of any product complaint.  If
the quality control unit conducts the investigation, final § 111.560(b)
would not apply.

    (Comment 320) Some comments object to the requirement in proposed §
111.95(c) that consumer complaints are to be investigated only when
there may be a relationship between product quality and an adverse
event.  These comments suggest this provision be extended to any
possible relationship between dietary supplements and adverse events,
including those that might be independent of whether the product is
produced under CGMPs.  These comments consider there should be
consistent procedures for handling product complaints, regardless of
whether the complaints relate to product quality.

     (Response) The action requested in these comments is outside the
scope of this rule, which specifically addresses CGMP requirements to
ensure the quality of the dietary supplement product.  However, we
encourage firms to investigate all product complaints in a consistent
way, regardless of whether the complaints relate to the quality of the
dietary supplement.

     (Comment 321) Some comments request clarification of statements
made or terms used in the preamble to the 2003 CGMP Proposal regarding
the handling of product complaints.  In the  preamble discussion of
proposed § 111.95(c), we stated a consumer complaint about adverse
effects “after consuming several dietary supplements” is worthy of
quality control unit investigation.  One comment asks about the meaning
of “several” and whether this example means that a manufacturer is
responsible for consumers who take more than the recommended dosage.

     (Response) In our discussion of proposed § 111.95(c) we addressed
a situation where a consumer had symptoms on more than one occasion
rather than a situation where a consumer took more than the recommended
dosage.  However, firms must investigate any complaint of illness or
injury even if a consumer reports that he/she has consumed more than the
amount recommended on the product label to determine if the complaint is
related to CGMP.

F.  Under this Subpart, What Records must You Make and Keep?  (Final
§ 111.570)

1.  Final § 111.570(a)

     Final § 111.570(a) requires you to make and keep the records
required under subpart O in accordance with subpart P.  Final
§ 111.570(a) derives from proposed § 111.95(f)(2) with changes
associated with the reorganization.

     We did not receive comments specific to proposed § 111.95(f)(2).

2.  Final § 111.570(b)(1)

     As discussed in § 111.570(b)(1) the final rule includes a new
requirement, final § 111.553, which requires written procedures for
fulfilling the requirements of subpart O.  Those written procedures are
records.  Another new provision, final § 111.570(b)(1), requires you
to make and keep a record of the written procedures for fulfilling the
requirements of subpart O.

3.  Final § 111.570(b)(2)

     Final § 111.570(b)(2) requires you to make and keep a written
record of every product complaint that is related to CGMP.  Final
§ 111.570(b)(2) derives from proposed § 111.95(e) which would
require that you

. . . make and keep a written record of every consumer complaint that is
related to good manufacturing practices.  For the purposes of the
regulations in this part, a consumer complaint about product quality may
or may not include concerns about a possible hazard to health.  However,
a consumer complaint does not include an adverse event, illness, or
injury related to the safety of a particular dietary ingredient
independent of whether the product is produced under good manufacturing
practices.

	As a revision for consistency with the definition of “product
complaint” in final § 111.3, final § 111.570(b)(2) does not
include the two full sentences from proposed § 111.95(e), as quoted
above.

4.  Final § 111.570(b)(2)(i)

     Final § 111.570(b)(2)(i) requires that the person who performs
the requirements of subpart O, at the time of performance, document and
record the performance.  Final § 111.570(b)(2)(i) is similar to
proposed § 111.95(f)(1) with changes associated with the
reorganization.

5.  Final § 111.570(b)(2)(ii)

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o made a change to include the date the complaint was received.

     (Comment 322) One comment notes proposed § 111.95(e)(4) would
require the written record of consumer complaints to include “how the
consumer used the product.”  The comment notes this information may
not always be available and suggests the words “where known” should
be added.

     (Response) We agree that there can be circumstances where the firm
that receives the product complaint may not know how the product was
used.  For example, a consumer may make a complaint by leaving a
telephone message before or after business hours and neither describe
how the product was used nor leave contact information so that the firm
could follow up with the consumer.  To address this comment, we provide
in the final rule that the written record of the product complaint
include “the nature of the complaint including, if known, how the
product was used.”

     (Comment 323) Some comments request clarification of statements
made or terms used in the preamble to the 2003 CGMP Proposal regarding
the handling of product complaints.  In our discussion of proposed
§ 111.95(e) we recommended that consumer complaints and investigations
be reported to us when consumption of a dietary supplement may be
related to “a serious adverse event.”  Some comments note that
“serious” is not defined.

     (Response) The term “serious adverse event” is widely used in
the industries we regulate.  Our forms for reporting “serious adverse
events” via the MedWatch program do not define the term, but instead
list outcomes that were attributed to an adverse event.  These outcomes
include death, life-threatening, hospitalization (initial or prolonged),
disability, congenital anomaly, required intervention to prevent,
permanent impairment/damage, and “other.”  We encourage firms who
are unsure as to whether the nature of a reported adverse event merits
reporting to FDA to contact us for assistance.

HHS/FDA-Internal-Confidential-Deliberative

Final Subpart O 9-28-05

Page   PAGE  908


[Federal Register Volume 87, Number 73 (Friday, April 15, 2022)]
[Notices]
[Pages 22551-22552]
[FR Doc No: 2022-08137]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2022-0002; Internal Agency Docket No. FEMA-B-2229]

Proposed Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, Department of Homeland
Security.

ACTION: Notice.

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

SUMMARY: Comments are requested on proposed flood hazard
determinations, which may include additions or modifications of any
Base Flood Elevation (BFE), base flood depth, Special Flood Hazard Area
(SFHA) boundary or zone designation, or regulatory floodway on the
Flood Insurance Rate Maps (FIRMs), and where applicable, in the
supporting Flood Insurance Study (FIS) reports for the communities
listed in the table below. The purpose of this notice is to seek
general information and comment regarding the preliminary FIRM, and
where applicable, the FIS report that the Federal Emergency Management
Agency (FEMA) has provided to the affected communities. The FIRM and
FIS report are the basis of the floodplain management measures that the
community is required either to adopt or to show evidence of having in
effect in order to qualify or remain qualified for participation in the
National Flood Insurance Program (NFIP).

DATES: Comments are to be submitted on or before July 14, 2022.

ADDRESSES: The Preliminary FIRM, and where applicable, the FIS report
for each community are available for inspection at both the online
location https://hazards.fema.gov/femaportal/prelimdownload and the
respective Community Map Repository address listed in the tables below.
Additionally, the current effective FIRM and FIS report for each
community are accessible online through the FEMA Map Service Center at
https://msc.fema.gov for comparison.
    You may submit comments, identified by Docket No. FEMA-B-2229, to
Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance
and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC
20472,<PHONE_NUMBER>, or (email) [email protected].

FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering
Services Branch, Federal Insurance and Mitigation Administration, FEMA,
400 C Street SW, Washington, DC 20472,<PHONE_NUMBER>, or (email)
[email protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: FEMA proposes to make flood hazard
determinations for each community listed below, in accordance with
section 110 of the Flood Disaster Protection Act of 1973, 42 U.S.C.
4104, and 44 CFR 67.4(a).
    These proposed flood hazard determinations, together with the
floodplain management criteria required by 44 CFR 60.3, are the minimum
that are required. They should not be construed to mean that the
community must change any existing ordinances that are more stringent
in their floodplain management requirements. The community may at any
time enact stricter requirements of its own or pursuant to policies
established by other Federal, State, or regional entities. These flood
hazard determinations are used to meet the floodplain management
requirements of the NFIP.
    The communities affected by the flood hazard determinations are
provided in the tables below. Any request for reconsideration of the
revised flood hazard information shown on the Preliminary FIRM and FIS
report that satisfies the data requirements outlined in 44 CFR 67.6(b)
is considered an appeal. Comments unrelated to the flood hazard
determinations also will be considered before the FIRM and FIS report
become effective.
    Use of a Scientific Resolution Panel (SRP) is available to
communities in support of the appeal resolution process. SRPs are
independent panels of experts in hydrology, hydraulics, and other
pertinent sciences established to review conflicting scientific and
technical data and provide recommendations for resolution. Use of the
SRP only may be exercised after FEMA and local communities have been
engaged in a collaborative consultation process for at least 60 days
without a mutually acceptable resolution of an appeal. Additional
information regarding the SRP process can be found online at https://www.floodsrp.org/pdfs/srp_overview.pdf.
    The watersheds and/or communities affected are listed in the tables
below. The Preliminary FIRM, and where

applicable, FIS report for each community are available for inspection
at both the online location https://hazards.fema.gov/femaportal/prelimdownload and the respective Community Map Repository address
listed in the tables. For communities with multiple ongoing Preliminary
studies, the studies can be identified by the unique project number and
Preliminary FIRM date listed in the tables. Additionally, the current
effective FIRM and FIS report for each community are accessible online
through the FEMA Map Service Center at https://msc.fema.gov for
comparison.

(Catalog of Federal Domestic Assistance No. 97.022, ``Flood
Insurance.'')

Michael M. Grimm,
Assistant Administrator for Risk Management, Department of Homeland
Security, Federal Emergency Management Agency.

------------------------------------------------------------------------
                                             Community map repository
               Community                             address
------------------------------------------------------------------------
           Monterey County, California and Incorporated Areas
         Project: 18-09-0046S Preliminary Date: October 21, 2021
------------------------------------------------------------------------
City of Gonzales.......................  Public Works Department, 147
                                          Fourth Street, Gonzales, CA
                                          93926.
City of Salinas........................  Public Works Department,
                                          Development Engineering
                                          Division, 200 Lincoln Avenue,
                                          Salinas, CA 93901.
City of Soledad........................  Public Works Department, 248
                                          Main Street, Soledad, CA
                                          93960.
Monterey County Unincorporated Areas...  Monterey County Government
                                          Center, Public Works,
                                          Facilities, and Parks
                                          Department, 2nd Floor, 1441
                                          Schilling Place, Salinas, CA
                                          93901.
------------------------------------------------------------------------

[FR Doc. 2022-08137 Filed 4-14-22; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 205 (Thursday, October 23, 2014)]
[Notices]
[Page 63453]
[FR Doc No: 2014-25204]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-73384; File No. SR-ICC-2014-14]

Self-Regulatory Organizations; ICE Clear Credit LLC; Notice of
Designation of Longer Period for Commission Action on Proposed Rule
Change To Add Rules Related to the Clearing of Standard Western
European Sovereign CDS Contracts

October 17, 2014.
    On August 25, 2014, ICE Clear Credit LLC (``ICC'') filed with the
Securities and Exchange Commission (``Commission'') the proposed rule
change SR-ICC-2014-14 pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'') \1\ and Rule 19b-4 thereunder.\2\ The
proposed rule change was published for comment in the Federal Register
on September 4, 2014.\3\ The Commission has not received comments on
the proposed rule change. The Commission is publishing this notice to
designate a longer period for Commission action on the proposed rule
change.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ Securities Exchange Act Release No. 34-72941 (Aug. 28,
2014), 79 FR 52794 (Sep. 4, 2014) (SR-ICC-2014-14).
---------------------------------------------------------------------------

    Section 19(b)(2) of the Act \4\ provides that within 45 days of the
publication of notice of the filing of a proposed rule change, or
within such longer period up to 90 days as the Commission may designate
if it finds such longer period to be appropriate and publishes its
reasons for so finding or as to which the self-regulatory organization
consents, the Commission shall either approve the proposed rule change,
disapprove the proposed rule change, or institute proceedings to
determine whether the proposed rule change should be disapproved. The
45th day from the publication of notice of filing of this proposed rule
change is October 19, 2014. The Commission is extending this 45-day
time period.
---------------------------------------------------------------------------

    \4\ 15 U.S.C. 78s(b)(2).
---------------------------------------------------------------------------

    ICC proposes to adopt new clearing rules and amend the ICC Risk
Management Framework to provide for the clearance of Standard Western
European Sovereign credit default swap (``CDS'') contracts,
specifically the Republic of Ireland, the Italian Republic, the
Portuguese Republic, and the Kingdom of Spain. Given that ICC does not
currently provide clearing services for Western European Sovereign CDS,
and it is proposing a new General Wrong Way Risk methodology to address
the potential wrong way risk associated with the clearing of sovereign
contracts, the Commission finds it appropriate to designate a longer
period within which to take action on the proposed rule change so that
it has sufficient time to consider the complex issues under the
proposed rule change.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\5\ designates December 3, 2014, as the date by which the
Commission should either approve or disapprove, or institute
proceedings to determine whether to disapprove, the proposed rule
change (File No. SR-ICC-2014-14).
---------------------------------------------------------------------------

    \5\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
---------------------------------------------------------------------------

    \6\ 17 CFR 200.30-3(a)(31).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2014-25204 Filed 10-22-14; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: April 11, 2008 (Volume 73, Number 71)]
[Notices]
[Page 19913-19914]
[DOCID:fr11ap08-116]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-57625; File No. SR-Amex-2008-28]

Self-Regulatory Organizations; American Stock Exchange LLC;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change
Relating to Rebates to Specialists for Options Transaction Fees
Resulting From Linkage P/A Orders

April 4, 2008.
    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 March 20, 2008, the American Stock Exchange LLC (``Amex'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by the
Exchange. The Exchange filed the proposed rule change pursuant to
Section 19(b)(3)(A) of the Act,\3\ and Rule 19b-4(f)(2) thereunder,\4\
which renders the proposal effective upon filing with the Commission.
The Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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

    Amex proposes to rebate options transaction fees incurred by
specialists in connection with a principal acting as agent order (``P/A
Order'') \5\ executed via the Intermarket Option Linkage (``Options
Linkage'' or ``Linkage''). The text of the proposed rule change is
available at Amex, the Commission's Public Reference Room, and http://
www.amex.com.
---------------------------------------------------------------------------

    \5\ A P/A Order as defined in Amex Rule 940(b)(10)(i) means an
order for the principal account of a specialist (or equivalent
entity on another Participant exchange that is authorized to
represent Public Customer Orders), reflecting the terms of a related
unexecuted Public Customer Order for which the specialist is acting
as agent. See Section 2(16)(a) of the Plan for the Purpose of
Creating and Operating an Intermarket Option Linkage.
---------------------------------------------------------------------------

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

Purpose
    The Exchange proposes to rebate options transaction fees incurred
by specialists as a result of the obligation to send customer orders
through the Linkage to the away options exchange disseminating the
national best bid or offer (``NBBO'').\6\ A P/A Order is used by
specialists for this purpose. Currently, a specialist will be charged
two separate transaction fees upon completion of a transaction
involving a P/A Order. First, the away options exchange will charge the
P/A Order a transaction fee upon execution of the order. This fee
varies by the particular options exchange. Second, in order to transfer
the trade resulting from the P/A Order at the away options exchange
into the customer account, the Amex specialist is then required to
execute a trade on the Exchange. At this point, the Exchange will
charge the applicable options transaction fees set forth in the Amex
Options Fee Schedule to the specialist. This proposal seeks to rebate
these exchange transaction fees incurred by specialists as a result of
the obligations imposed by the Options Linkage.
---------------------------------------------------------------------------

    \6\ The proposed fee rebate of transaction fees incurred by
specialists as a result of the obligation to send P/A Orders does
not include the rebate of OCC fees and clearing firm fees associated
with P/A Orders. See e-mail from Jeff Burns, Vice President &
Associate General Counsel, Amex, to Brian O'Neill, Attorney, and
Molly Kim, Special Counsel, Division of Trading and Markets,
Commission, on April 1, 2008 (``April 1 E-mail'').
---------------------------------------------------------------------------

    The current Amex Options Fee Schedule imposes a charge of $0.20 per
contract side on specialist trades in equity options and $0.31 per
contract side on specialist trades for index options. In connection
with transferring the P/A Order execution into the customer account,
the Amex specialist will incur a charge of $0.20 or $0.31 per contract
side, depending on whether the option is an equity option or index
option. Under this proposal, the Exchange will rebate the transaction
charges incurred by the specialist to transfer the P/A Order execution
into the customer account.\7\ In addition, on a monthly basis, the
Exchange will calculate the amount of the transaction fees incurred by
the specialist in connection with his or her obligation to send P/A
Orders to away options exchanges. This amount will also be

credited to the specialist account for that month's charges.
---------------------------------------------------------------------------

    \7\ The proposal to rebate transaction fees incurred by
specialists as a result of the obligations imposed by the Options
Linkage would also include any specialist subject to the BD Auto-Ex
Fee. This could occur if a specialist submitted an order
electronically through order-entry lines, such as CMS and/or FIX,
for automatic execution, for the purpose of transferring a trade
resulting from the P/A Order at the away options exchange into the
customer account. The Exchange would then charge to the specialist,
the BD Auto-Ex Fee together with the other applicable options
transaction fees set forth in the Options Fee Schedule. The proposal
set forth in this proposal seeks to rebate these transaction fees
incurred by a specialist. See e-mail from the Jeff Burns, Vice
President & Associate General Counsel, Amex, to Brian O'Neill,
Attorney, and Molly Kim, Special Counsel, Division of Trading and
Markets, Commission, on April 3, 2008.
---------------------------------------------------------------------------

    In order for a specialist to be subject to the fee rebates under
this proposal, the Exchange will require that specialists use the
``Auto Route'' functionality in ANTE for orders up to 1,000
contracts.\8\ Auto Route automatically sends a P/A Order through the
Linkage to execute against the NBBO at another options exchange.\9\
---------------------------------------------------------------------------

    \8\ As long as a specialist satisfies this condition, such
specialist would be eligible for the fee rebate, regardless of the
size of the order received. For example, if the specialist satisfies
the rebate condition and sets the Auto Route functionality in ANTE
for orders up to 1,000 contracts, such specialist would be eligible
for the fee rebate even though the order received is greater than
1,000 contracts and thereby not subject to auto routing but to
manual handling by the specialist. See April 1 E-mail, supra note 6.
    \9\ Auto Route automatically sends a P/A Order through the
Linkage to execute against the NBBO at another options exchange if
such order is not executable against the Amex best bid or offer. See
April 1 E-mail, supra note 6.
---------------------------------------------------------------------------

    The Exchange believes that this proposal to rebate specialist
transaction charges associated with P/A Orders is necessary in order
for the Exchange to remain competitive with other options exchanges
that currently provide transaction fee rebates/credits for executing
orders through the Linkage. The Exchange states that both the Chicago
Board Options Exchange, Incorporated and the Philadelphia Stock
Exchange, Inc. have fee rebate or credit programs for fees incurred
executing orders through the Linkage.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\10\ in general, and furthers the objectives of Section
6(b)(4),\11\ in particular, in that it is designed to provide for the
equitable allocation of reasonable dues, fees, and other charges among
its members and issuers and other persons using its facilities. The
Exchange believes that the proposal provides for an equitable
allocation of reasonable fees among members consistent with Section
6(b)(4),\12\ by rebating/crediting transaction fees incurred by a
specialist as a result of the obligation imposed by the sending of P/A
Orders through the Linkage.
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78f(b).
    \11\ 15 U.S.C. 78f(b)(4).
    \12\ Id.
---------------------------------------------------------------------------

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.

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 foregoing proposed rule change is effective upon filing
pursuant to Section 19(b)(3)(A)(ii) \13\ of the Act and Rule 19b-
4(f)(2) \14\ thereunder, because it establishes or changes a due, fee,
or other charge applicable only to a member imposed by the Exchange. At
any time within 60 days of the filing of the proposed rule change, the
Commission may summarily abrogate 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.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78s(b)(3)(A)(ii).
    \14\ 17 CFR 240.19b-4(f)(2).
---------------------------------------------------------------------------

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-Amex-2008-28 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-Amex-2008-28. This file
number should be included on the subject line if e-mail 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 inspection and
copying in the Commission's Public Reference Room, on official business
days between the hours of 10 a.m. and 3 p.m. Copies of such filing will
also 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 No. SR-Amex-
2008-28 and should be submitted on or before May 2, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E8-7656 Filed 4-10-08; 8:45 am]

BILLING CODE 8011-01-P


Les changements climatiques sont au cœur de l’actualité. Nous sommes
tous concernés sans exception. Ils marquent nos vies chaque jour. Ils
ont des effets dévastateurs sur nos économies.  Aussi, le prix devient
trop lourd à payer tant en termes d’argent que de vies. Il faut donc
accélérer l’action. C’est ce qu’encourage l’Organisation des
Nations Unies pour le  sommet mondial 2014 sur le climat qui aura lieu
le 23 septembre 2014 à New York.  Il rassemblera autour de cette cause
commune les dirigeants d’Etats, de structure et la société civile
pour impulser une nouvelle dynamique collective : la lutte contre le
changement climatique. La situation est telle qu’il convient d’agir
pour les générations actuelles en premier lieu tout en pensant aux
générations futures. Ce tournant décisif mettra en lumière des
actions exceptionnelles qui pourront être capitalisées et dupliquées
en d’autres lieux.

Aujourd’hui nous avons besoin d'une évolution homéopathique ou d'une
révolution sur cette problématique qui chaque jour touche de plus en
plus des populations affamées.

 Il faut un exemple fort significatif d’un pays membre permanent du
conseil de sécurité de l’ONU qui puisse parler d’une voix et qui
puisse se faire écho dans le monde entier. C’est le cas du  CLIMATE
ACTION PLAN du président des Etats-Unis Mr Barack OBAMA, conforté par
le CLEAN POWER PLAN de l’EPA (Environmental Protection Agency).
Voilà une mesure audacieuse révolutionnaire qui doit être soulignée
comme entrant dans le champ du MAPEX (Management de projets
d’excellence). Pour féliciter cette excellente  initiative, c’est
avec un grand plaisir que nous avons préparé une vidéo qui montre que
c’est bien un projet d’excellence car bien qu’il ait pris
naissance aux Etats-Unis, il concerne aussi toute la planète :

«  MAPEX, CLIMATE ACTION PLAN

CLEAN POWER PLAN »

 Nous vous encourageons tous à découvrir ce projet d’excellence, à
le soutenir, à en devenir des  acteurs et surtout à le partager avec
vos amis et connaissances.


[Federal Register Volume 79, Number 8 (Monday, January 13, 2014)]
[Notices]
[Pages 2167-2168]
[FR Doc No: 2014-00375]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OECA-2013-0302; FRL-9904-93-OEI]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; NSPS for the Graphic Arts Industry (40 CFR
Part 60, Subpart QQ) (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency has submitted an
information collection request (ICR), ``NSPS for the Graphic Arts
Industry (40 CFR part 60, Subpart QQ) (Renewal)'' (EPA ICR No. 0657.11,
OMB Control No. 2060-0105), to the Office of Management and Budget
(OMB) for review and approval in accordance with the Paperwork
Reduction Act (44 U.S.C. 3501 et seq). This is a proposed extension of
the ICR, which is currently approved through March 31, 2014. Public
comments were previously requested via the Federal Register (78 FR
33409) on June 4, 2013

during a 60-day comment period. This notice allows for an additional 30
days for public comments. A fuller description of the ICR is given
below, including its estimated burden and cost to the public. An 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.

DATES: Additional comments may be submitted on or before February 12,
2014.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OECA-2013-0302, to: (1) EPA online, using www.regulations.gov (our
preferred method), by email to<EMAIL_ADDRESS>or by mail to: EPA
Docket Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW., Washington, DC 20460; and (2) OMB via email to
<EMAIL_ADDRESS>Address comments to OMB Desk Officer for
EPA.
    EPA's policy is that all comments received will be included in the
public docket without change including any personal information
provided, unless the comment includes profanity, threats, information
claimed to be Confidential Business Information (CBI) or other
information whose disclosure is restricted by statute.

FOR FURTHER INFORMATION CONTACT: Learia Williams, Monitoring,
Assistance, and Media Programs Division, Office of Compliance, Mail
Code 2227A, Environmental Protection Agency, 1200 Pennsylvania Ave.
NW., Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW., Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit www.epa.gov/dockets.
    Abstract: The New Source Performance Standards (NSPS) for the
Graphic Arts Industry (40 CFR part 60, subpart QQ) were proposed on
October 28, 1980, and promulgated on November 8, 1982. The affected
entities are subject to the General Provisions of the NSPS at 40 CFR
part 60, subpart A and any changes, or additions to the Provisions
specified at 40 CFR part 60, subpart QQ.
    Owners or operators of the affected facilities must make an initial
notification report, performance tests, periodic reports, and maintain
records of the occurrence and duration of any startup, shutdown, or
malfunction in the operation of an affected facility, or any period
during which the monitoring system is inoperative. Reports are required
semiannually at a minimum.
    Form Numbers: None.
    Respondents/Affected Entities: Graphic arts facilities.
    Respondent's Obligation to Respond: Mandatory (40 CFR part 60,
subpart QQ).
    Estimated Number of Respondents: 20.33 (total).
    Frequency of Response: Initially and semiannually.
    Total Estimated Burden: 1,802 hours (per year). ``Burden'' is
defined at 5 CFR 1320.3(b).
    Total Estimated Cost: $176,264 (per year), which also includes no
annualized capital or operation & maintenance costs.
    Changes in the Estimates: There is an increase in the total
estimated respondent burden as currently identified in the OMB
Inventory of Approved Burdens. The change in burden is due to an
increase in the number of sources subject to these standards, and is
not due to any program changes. The number of sources has been
increased to account for industry growth that has occurred since the
most-recent ICR was approved.
    Also, there is an increase in the respondent cost from the most
recently-approved ICR due to the use of updated labor rates. This ICR
references labor rates from the Bureau of Labor Statistics to calculate
the respondent burden cost.
    There is a decrease in the total estimated Agency burden as
compared to the most recently-approved ICR. This change is due to a
revision in the labor burden estimate for repeat performance testing.
Due to a discrepancy in the previous ICR, the labor burden for repeat
performance testing included respondents who passed the initial
performance test. The revision accounts only for respondents who failed
the initial performance test resulted in the reduced labor burden
observed in this ICR. Also, note that the ICR also incorporates updated
labor rates from OPM.

John Moses,
Director, Collection Strategies Division.
[FR Doc. 2014-00375 Filed 1-10-14; 8:45 am]
BILLING CODE 6560-50-P