[Federal Register Volume 79, Number 250 (Wednesday, December 31, 2014)]
[Rules and Regulations]
[Pages 78719-78722]
[FR Doc No: 2014-30545]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

44 CFR Part 64

[Docket ID FEMA-2014-0002; Internal Agency Docket No. FEMA-8363]

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 http://www.fema.gov/fema/csb.shtm.

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 David Stearrett, Federal Insurance and
Mitigation Administration, Federal Emergency Management Agency, 500 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. This rule is categorically
excluded from the requirements of 44 CFR part 10, Environmental
Considerations. No environmental impact assessment has been prepared.
    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:

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                                                  Effective date                                 Date certain
                                Community   authorization/cancellation   Current  effective   Federal assistance
      State and location           No.           of sale of  flood            map date            no longer
                                              insurance in community                         available  in SFHAs
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                                                   Region III
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Maryland:
    Caroline County,                240130  June 18, 1974, Emerg;       January 16, 2015...  January 16, 2015.
     Unincorporated Areas.                   October 15, 1980, Reg;
                                             January 16, 2015, Susp.
    Denton, Town of, Caroline       240104  September 24, 1974, Emerg;  * ......do.........   Do.
     County.                                 December 18, 1979, Reg;
                                             January 16, 2015, Susp.
    Federalsburg, Town of,          240013  November 5, 1971, Emerg;    ......do...........   Do.
     Caroline and Dorchester                 March 15, 1977, Reg;
     Counties.                               January 16, 2015, Susp.
    Greensboro, Town of,            240014  December 27, 1974, Emerg;   ......do...........   Do.
     Caroline County.                        November 1, 1979, Reg;
                                             January 16, 2015, Susp.
    Hillsboro, Town of,             240111  February 27, 1975, Emerg;   ......do...........   Do.
     Caroline County.                        February 12, 1982, Reg;
                                             January 16, 2015, Susp.
Pennsylvania:
    Bellefonte, Borough of,         420257  March 30, 1973, Emerg;      ......do...........   Do.
     Centre County.                          February 2, 1977, Reg;
                                             January 16, 2015, Susp.
    Benner, Township of,            421460  April 7, 1975, Emerg; June  ......do...........   Do.
     Centre County.                          5, 1989, Reg; January 16,
                                             2015, Susp.
    Howard, Borough of,             420263  May 13, 1975, Emerg;        ......do...........   Do.
     Centre County.                          August 3, 1989, Reg;
                                             January 16, 2015, Susp.
    Howard, Township of,            421464  February 9, 1976, Emerg;    ......do...........   Do.
     Centre County.                          August 3, 1989, Reg;
                                             January 16, 2015, Susp.
    Liberty, Township of,           421196  April 13, 1976, Emerg;      ......do...........   Do.
     Centre County.                          June 5, 1989, Reg;
                                             January 16, 2015, Susp.
    Marion, Township of,            421465  July 29, 1975, Emerg;       ......do...........   Do.
     Centre County.                          November 2, 1984, Reg;
                                             January 16, 2015, Susp.
    Spring, Township of,            420269  October 13, 1972, Emerg;    ......do...........   Do.
     Centre County.                          April 15, 1977, Reg;
                                             January 16, 2015, Susp.
Virginia:
    Virginia Beach, City of,        515531  September 11, 1970, Emerg;  ......do...........   Do.
     Independent City.                       April 23, 1971, Reg;
                                             January 16, 2015, Susp.
    York County,                    510182  October 5, 1973, Emerg;     ......do...........   Do.
     Unincorporated Areas.                   December 16, 1988, Reg;
                                             January 16, 2015, Susp.
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                                                    Region V
----------------------------------------------------------------------------------------------------------------
Indiana:
    Burlington, Town of,            180318  March 21, 1977, Emerg;      ......do...........   Do.
     Carroll County.                         June 8, 1984, Reg;
                                             January 16, 2015, Susp.
    Carroll County,                 180019  October 28, 1975, Emerg;    ......do...........   Do.
     Unincorporated Areas.                   November 15, 1989, Reg;
                                             January 16, 2015, Susp.
    Delphi, City of, Carroll        180020  July 25, 1975, Emerg;       ......do...........   Do.
     County.                                 August 1, 1995, Reg;
                                             January 16, 2015, Susp.
    Flora, Town of, Carroll         180021  April 9, 1975, Emerg;       ......do...........   Do.
     County.                                 November 1, 1995, Reg;
                                             January 16, 2015, Susp.
Michigan:
    Belding, City of, Ionia         260096  February 10, 1976, Emerg;   ......do...........   Do.
     County.                                 June 17, 1986, Reg;
                                             January 16, 2015, Susp.
    Danby, Township of, Ionia       261438  November 22, 2013, Emerg;   ......do...........   Do.
     County.                                 N/A, Reg; January 16,
                                             2015, Susp.
    Easton, Township of,            260727  June 28, 1982, Emerg; May   ......do...........   Do.
     Ionia County.                           25, 1984, Reg; January
                                             16, 2015, Susp.
    Ionia, City of, Ionia           260097  April 28, 1975, Emerg;      ......do...........   Do.
     County.                                 November 2, 1983, Reg;
                                             January 16, 2015, Susp.
    Ionia, Township of, Ionia       260832  January 22, 1991, Emerg;    ......do...........   Do.
     County.                                 May 2, 1999, Reg; January
                                             16, 2015, Susp.
    Lake Odessa, Village of,        260419  October 22, 1975, Emerg;    ......do...........   Do.
     Ionia County.                           September 29, 1986, Reg;
                                             January 16, 2015, Susp.
    Lyons, Village of, Ionia        261440  October 22, 2013, Emerg; N/ ......do...........   Do.
     County.                                 A, Reg; January 16, 2015,
                                             Susp.
    Muir, Village of, Ionia         260916  June 20, 1994, Emerg;       ......do...........   Do.
     County.                                 November 6, 1996, Reg;
                                             January 16, 2015, Susp.
    Portland, City of, Ionia        260574  September 5, 1975, Emerg;   ......do...........   Do.
     County.                                 May 1, 1984, Reg; January
                                             16, 2015, Susp.

    Portland, Township of,          260831  January 22, 1991, Emerg;    ......do...........   Do.
     Ionia County.                           June 16, 1992, Reg;
                                             January 16, 2015, Susp.
    Saranac, Village of,            260421  September 3, 1976, Emerg;   ......do...........   Do.
     Ionia County.                           June 17, 1986, Reg;
                                             January 16, 2015, Susp.
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                                                   Region VII
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Missouri:
    Canton, City of, Lewis          290204  March 25, 1974, Emerg;      ......do...........   Do.
     County.                                 February 1, 1977, Reg;
                                             January 16, 2015, Susp.
    Lewis County,                   290844  June 18, 1982, Emerg;       ......do...........   Do.
     Unincorporated Areas.                   September 1, 1989, Reg;
                                             January 16, 2015, Susp.
----------------------------------------------------------------------------------------------------------------
                                                   Region VIII
----------------------------------------------------------------------------------------------------------------
Montana:
    Darby, Town of, Ravalli         300062  N/A, Emerg; November 2,     ......do...........   Do.
     County.                                 1998, Reg; January 16,
                                             2015, Susp.
    Hamilton, City of,              300186  N/A, Emerg; November 10,    ......do...........   Do.
     Ravalli County.                         1989, Reg; January 16,
                                             2015, Susp.
    Ravalli County,                 300061  April 11, 1978, Emerg;      ......do...........   Do.
     Unincorporated Areas.                   July 19, 1982, Reg;
                                             January 16, 2015, Susp.
    Stevensville, City of,          300181  N/A, Emerg; November 16,    ......do...........   Do.
     Ravalli County.                         2012, Reg; January 16,
                                             2015, Susp.
North Dakota:
    Argusville, City of, Cass       380639  April 25, 1980, Emerg;      ......do...........   Do.
     County.                                 February 19, 1986, Reg;
                                             January 16, 2015, Susp.
    Barnes, Township of, Cass       380256  December 27, 1976, Emerg;   ......do...........   Do.
     County.                                 September 27, 1985, Reg;
                                             January 16, 2015, Susp.
    Briarwood, City of, Cass        380651  April 2, 1982, Emerg;       ......do...........   Do.
     County.                                 September 27, 1985, Reg;
                                             January 16, 2015, Susp.
    Fargo, City of, Cass            385364  April 10, 1970, Emerg;      ......do...........   Do.
     County.                                 April 30, 1971, Reg;
                                             January 16, 2015, Susp.
    Frontier, City of, Cass         380347  February 14, 2012, Emerg;   ......do...........   Do.
     County.                                 N/A, Reg; January 16,
                                             2015, Susp.
    Harwood, City of, Cass          380338  April 11, 1978, Emerg;      ......do...........   Do.
     County.                                 September 30, 1980, Reg;
                                             January 16, 2015, Susp.
    Harwood, Township of,           380259  March 23, 1978, Emerg;      ......do...........   Do.
     Cass County.                            October 15, 1980, Reg;
                                             January 16, 2015, Susp.
    Horace, City of, Cass           380022  November 28, 1975, Emerg;   ......do...........   Do.
     County.                                 July 2, 1981, Reg;
                                             January 16, 2015, Susp.
    Mapleton, Township of,          380262  March 8, 1978, Emerg;       ......do...........   Do.
     Cass County.                            October 1, 1986, Reg;
                                             January 16, 2015, Susp.
    North River, City of,           380623  March 29, 1979, Emerg;      ......do...........   Do.
     Cass County.                            September 27, 1985, Reg;
                                             January 16, 2015, Susp.
    Oxbow, City of, Cass            380681  N/A, Emerg; November 10,    ......do...........   Do.
     County.                                 1989, Reg; January 16,
                                             2015, Susp.
    Pleasant, Township of,          380263  March 21, 1978, Emerg;      ......do...........   Do.
     Cass County.                            February 3, 1982, Reg;
                                             January 16, 2015, Susp.
    Prairie Rose, City of,          380655  July 12, 1982, Emerg; June  ......do...........   Do.
     Cass County.                            29, 1985, Reg; January
                                             16, 2015, Susp.
    Raymond, Township of,           380261  March 24, 1978, Emerg;      ......do...........   Do.
     Cass County.                            October 1, 1986, Reg;
                                             January 16, 2015, Susp.
    Reed, Township of, Cass         380257  December 27, 1977, Emerg;   ......do...........   Do.
     County.                                 October 15, 1980, Reg;
                                             January 16, 2015, Susp.
    Reiles Acres, City of,          380324  March 22, 1978, Emerg;      ......do...........   Do.
     Cass County.                            September 30, 1987, Reg;
                                             January 16, 2015, Susp.
    Stanley, Township of,           380258  May 7, 1976, Emerg; July    ......do...........   Do.
     Cass County.                            5, 1982, Reg; January 16,
                                             2015, Susp.
    Warren, Township of, Cass       380265  February 20, 1978, Emerg;   ......do...........   Do.
     County.                                 May 1, 1986, Reg; January
                                             16, 2015, Susp.
    West Fargo, City of, Cass       380024  December 6, 1973, Emerg;    ......do...........   Do.
     County.                                 April 17, 1978, Reg;
                                             January 16, 2015, Susp.
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* ......do = Ditto.
Code for reading third column: Emerg.--Emergency; Reg.--Regular; Susp.--Suspension.

    Dated: December 4, 2014.
David L. Miller,
Associate Administrator, Federal Insurance and Mitigation
Administration, Department of Homeland Security, Federal Emergency
Management Agency.
[FR Doc. 2014-30545 Filed 12-30-14; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 79, Number 231 (Tuesday, December 2, 2014)]
[Notices]
[Page 71435]
[FR Doc No: 2014-28256]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-D-0295]

Guidance for Industry on Scale-Up Post-Approval Changes:
Manufacturing Equipment Addendum; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a scale-up and post-approval changes (SUPAC) guidance
for industry entitled ``SUPAC: Manufacturing Equipment Addendum.'' This
replaces the draft guidance of the same name that combined and
superseded ``SUPAC IR/MR: Immediate Release and Modified Release Solid
Oral Dosage Forms: Manufacturing Equipment Addendum,'' published on
January 1, 1999; and ``SUPAC-SS: Nonsterile Semisolid Dosage Forms;
Manufacturing Equipment Addendum,'' published as a draft on December 1,
1998. FDA revised the draft manufacturing equipment addenda to remove
the equipment examples and to clarify the types of processes being
referenced.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993. Send one self-addressed
adhesive label to assist that office in processing your requests. See
the SUPPLEMENTARY INFORMATION section for electronic access to the
guidance document.
    Submit electronic comments on the guidance 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.

FOR FURTHER INFORMATION CONTACT: Akm Khairuzzaman, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a SUPAC guidance for industry
entitled ``SUPAC: Manufacturing Equipment Addendum.'' This guidance
replaces the draft guidance of the same name that superseded the
following guidances for industry: (1) ``SUPAC IR/MR: Immediate Release
and Modified Release Solid Oral Dosage Forms: Manufacturing Equipment
Addendum,'' published on January 1, 1999, and (2) ``SUPAC-SS:
Nonsterile Semisolid Dosage Forms; Manufacturing Equipment Addendum,
``published as draft on December 1, 1998. When published, these
guidances included tables that listed specific equipment that were
misinterpreted as a list of FDA required equipment. In addition, FDA is
concerned that the equipment addenda may no longer reflect current
practices and may be limiting, instead of encouraging, manufacturers to
continually evaluate and update practices. FDA has removed the tables
listing specific manufacturing equipment from these guidances and
combined them into a single addendum. FDA has also made some changes to
clarify the types of processes being referenced.
    This guidance should be used with the following guidances for
industry to determine what documentation should be submitted to FDA
regarding equipment changes: (1) ``SUPAC-IR: Immediate Release Solid
Oral Dosage Forms--Scale-Up and Post-Approval Changes: Chemistry,
Manufacturing and Controls, In Vitro Dissolution Testing, and In Vivo
Bioequivalence Documentation,'' (2) ``SUPAC-MR: Modified Release Solid
Oral Dosage Forms Scale-Up and Post-Approval Changes: Chemistry,
Manufacturing and Controls; In Vitro Dissolution Testing and In Vivo
Bioequivalence Documentation,'' and (3) ``SUPAC-SS: Nonsterile
Semisolid Dosage Forms, Scale-Up and Post Approval Changes: Chemistry
Manufacturing and Controls; In Vitro Release Testing and In Vivo
Bioequivalence Documentation.''
    As part of a greater effort, FDA is thoroughly reviewing the SUPAC
guidance series to determine how these guidances fit with current
manufacturing practices, including, but not limited to, risk-based
assessment approaches and quality by design principles. This guidance
is being issued consistent with FDA's good guidance practices
regulation (21 CFR 10.115). This guidance represents the Agency's
current thinking on manufacturing equipment. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send 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, and will be posted to the docket at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: November 25, 2014.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2014-28256 Filed 12-1-14; 8:45 am]
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