<!DOCTYPE HTML PUBLIC "-//-//W3C//DTD HTML 3.2//EN">

<META name="generator" content="Guidance for Industry Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors ">
<META name="creation-date" content="18/04/2008 11:33:56 ">
<TITLE>Guidance for Industry Certain Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) Recovered From Donors </TITLE>

Guidance for Industry
Certain Human Cells, Tissues, and
Cellular and Tissue-Based Products
(HCT/Ps) Recovered From Donors
Who Were Tested For Communicable
Diseases Using Pooled Specimens or
Diagnostic Tests
This guidance is for immediate implementation.
FDA is issuing this guidance for immediate implementation in accordance with 21 CFR
10.115(g)(4)(i).  Submit written comments on this guidance at anytime to the Division of
Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.  Submit electronic comments to http://www.regulations.gov.  You should
identify all comments with the Docket Number 2007D-0017.
Additional copies of this guidance are available from the Office of Communication, Training and
Manufacturers Assistance (HFM-40), 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448, or by calling 1-800-835-4709 or<PHONE_NUMBER>, or from the Internet at
http://www.fda.gov/cber/guidelines.htm.
For questions on the content of this guidance, contact Division of Human Tissues, Office of
Cellular, Tissue and Gene Therapies at<PHONE_NUMBER>.
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Biologics Evaluation and Research
April 2008

Contains Nonbinding Recommendations
Table of Contents
I.
INTRODUCTION............................................................................................................. 1
II.
BACKGROUND ............................................................................................................... 2
III.
INVESTIGATION AND CORRECTIVE ACTIONS................................................... 3
IV.
HCT/P DEVIATION REPORTS FOR DISTRIBUTED HCT/PS............................... 4
A.
Are These Testing Deficiencies Considered HCT/P Deviations and Do They
Relate to Core Current Good Tissue Practice Requirements?......................... 4
B.
Am I Required to Report an HCT/P Deviation for the HCT/Ps I Distributed?
...............................................................................................................................
..
4
C.
How Should I Report an HCT/P Deviation? ...................................................... 5
D.
Which Establishment Should Submit the HCT/P Deviation Report? ............. 5
V.
MITIGATION OF RISK OF HCT/PS IN INVENTORY............................................. 5
A.
What Should I Do after Quarantining HCT/Ps in Inventory?......................... 5
B.
Which Donors Should be Retested and May I Distribute These HCT/Ps? ..... 6
C.
How Should I Label the HCT/P When I Distribute Them Without Retesting?
...............................................................................................................................
..
8
i

Contains Nonbinding Recommendations
Guidance for Industry
Certain Human Cells, Tissues, and Cellular and Tissue-Based
Products (HCT/Ps) Recovered from Donors Who
Were Tested For Communicable Diseases Using
Pooled Specimens or Diagnostic Tests
This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this
topic.  It does not create or confer any rights for or on any person and does not operate to bind
FDA or the public.  You can use an alternative approach if the approach satisfies the
requirements of the applicable statutes and regulations.  If you want to discuss an alternative
approach, contact the appropriate FDA staff.  If you cannot identify the appropriate FDA staff,
call the appropriate number listed on the title page of this guidance.
I. INTRODUCTION
This guidance provides you, an establishment that makes donor eligibility determinations for
1
certain human cells, tissues, and cellular and tissue-based products (HCT/Ps), with
recommendations concerning the donor eligibility and additional requirements under Title 21
Code of Federal Regulations, Part 1271, Subpart C (21 CFR Part 1271, Subpart C).  This
guidance updates and replaces the January 2007 guidance of the same title to:
x
clarify that for the purposes of this guidance the term “certain HCT/Ps” also includes
certain donor lymphocytes for infusion (DLIs), namely those lymphocytes for infusion
collected from the same donor as hematopoietic progenitor/stem cells (HPCs);
x
provide updated recommendations regarding donor testing using pooled specimens of
2
HPCs and DLIs (as specified above) due to the approval of Biologics License
Application (BLA) supplements from two nucleic acid test manufacturers (see footnotes
5 through 7); and
x
specify that this guidance applies to certain HCT/Ps recovered from donors beginning on
or after May 25, 2005 through February 23, 2007.
This guidance addresses certain HCT/Ps that were tested for communicable diseases using
pooled specimens or diagnostic tests.  For the purposes of this guidance, certain HCT/Ps means
HPCs, DLIs (as specified above), and reproductive cells and tissues.
3
This guidance applies only
1
Under 21 CFR 1271.3(b)(2), an establishment includes facilities that engage in contract manufacturing services for
a manufacturer of HCT/Ps (e.g., laboratories that perform donor testing under contract, agreement, or other
arrangement with an establishment).
2
Donor testing should be performed using the appropriate plasma, serum or blood sample as indicated in the
manufacturer’s instructions.  The HCT/Ps are not tested directly.
3
FDA does not include tissues previously subject to regulation under 21 CFR Part 1270 within the category of
“certain HCT/Ps” addressed in this guidance.  Instead, we limit the application of this document to certain HCT/Ps
not previously regulated as HCT/Ps.
1

Contains Nonbinding Recommendations
to certain HCT/Ps recovered from donors beginning on or after May 25, 2005 (the effective date
4
of the regulations contained in 21 CFR Part 1271, Subpart C), through February 23, 2007.
5
FDA’s guidance documents, including this guidance, do not establish legally enforceable
responsibilities.  Instead, guidances describe the FDA’s current thinking on a topic and should be
viewed only as recommendations, unless specific regulatory or statutory requirements are cited.
The use of the word should in FDA’s guidances means that something is suggested or
recommended, but not required.
II. BACKGROUND
FDA’s new donor screening and testing regulations became effective on May 25, 2005
(21 CFR Part 1271, Subpart C).  Section 1271.80(c) (21 CFR 1271.80(c)) of those regulations
requires testing establishments to use appropriate FDA-licensed, approved, or cleared donor
screening tests, in accordance with the manufacturer’s instructions, to adequately and
appropriately reduce the risk of transmission of relevant communicable disease agents or
diseases.  FDA has learned that some testing laboratories that perform communicable disease
testing on donors of certain HCT/Ps have failed to comply with this provision.  This guidance
addresses two categories of compliance problems.  Some laboratories, apparently familiar with
pooling instructions for blood and plasma donor specimens, performed Nucleic Acid Testing
(NAT) for human immunodeficiency virus, type 1 (HIV-1) and hepatitis C virus (HCV) on
pooled HCT/P donor specimens, even though the manufacturer’s instructions (package inserts)
for the NAT tests specified that testing be performed on individual HCT/P donor specimens.
Also, some test laboratories used diagnostic tests to test HCT/P donor specimens rather than the
FDA-licensed donor screening tests required by 21 CFR 1271.80(c).  Thus, in these two
situations, establishments failed to perform donor testing in accordance with the regulations.
FDA has received inquiries from establishments and professional associations regarding certain
HCT/Ps affected by these testing deficiencies that were distributed or are currently in inventory.
We, FDA, believe that the use of certain HCT/Ps recovered from donors tested in the situations
described above may introduce some additional risk of communicable disease transmission.
When NAT is performed on pooled donor specimens, the sensitivity of the test may not be
comparable to the sensitivity of the test when performed according to the test kit manufacturer’s
instructions.  For instance, the HIV-1 and HCV NAT tests have not been established as
adequately sensitive when samples from certain HCT/P donors are tested in pools. Similarly,
some tests cleared or approved by FDA for diagnostic use have not been demonstrated to be as
sensitive as FDA-licensed, approved, or cleared donor screening tests.
FDA has also compared this incremental risk to the costs to patients if these products are
unavailable.  For example, patients may die if human leukocyte antigen (HLA) matched HPCs
and DLIs are unavailable.  We think that, given the expected benefits of using such HCT/Ps,
under these circumstances, patients may wish to accept the small increased risk presented by
4
69
Federal Register 29785, May 25, 2004; correction 71 Federal Register 14798, March 24, 2006.
5
February 23, 2007, is 30 days after the publication date of the Federal Register notice announcing the availability
of the guidance of the same title, dated January 2007 (72 Federal Register 3149, January 24, 2007).
2

Contains Nonbinding Recommendations
these testing deficiencies, provided the labeling is appropriate and accurately reflects the
increased risk.  Accordingly, in this guidance document, we describe ways to help mitigate the
small increased risk presented by these two testing deficiencies.  Ways to mitigate include
retesting the donor or justifying why this is not possible, using special labeling for the HCT/P,
and physician notification.  With respect to these two categories of testing deficiencies, when the
deficiency occurred soon after the effective date of 21 CFR 1271.80 (see next paragraph), and
when the increased risk is appropriately mitigated (see Section V.), we intend to exercise
enforcement discretion not to prevent distribution of these HCT/Ps.
The recommendations described in this guidance are limited to the two testing deficiencies
described in this guidance; these recommendations do not apply to other failures to comply with
21 CFR 1271.80.  Moreover, we intend to exercise our enforcement discretion as described in
this guidance only with respect to certain HCT/Ps recovered from donors beginning on or after
May 25, 2005, through February 23, 2007 (see footnotes 3 and 4).  After February 23, 2007, the
agency expects HCT/P establishments and testing laboratories to have corrected their procedures
such that they are in full compliance with testing regulations in 21 CFR 1271.80.
III.
INVESTIGATION AND CORRECTIVE ACTIONS
Any establishment that performed donor testing subject to one of the two deficiencies described
in this guidance must investigate those deficiencies and ensure that appropriate corrective actions
have been taken to prevent the events described above from occurring again
(21 CFR 1271.160(b)(2) and (3)).  If the establishment was a laboratory that performed such
donor testing under a contract, agreement, or other arrangement with another HCT/P
establishment(s), the laboratory must notify the affected HCT/P establishment(s)
(21 CFR 1271.160(b)(2)(ii)).  Whether it performed the testing in-house, or contracted with a
laboratory to perform donor testing, the HCT/P establishment(s) must investigate and determine
which distributed HCT/Ps are affected by these testing deficiencies.  This includes identification
of affected HCT/Ps that were distributed, and identification of affected HCT/Ps that are in
inventory (21 CFR 1271.160(b)(3)(i)).
Establishments should identify, quarantine, and not distribute HCT/Ps currently in inventory that
were obtained from donors tested using pooled specimens or diagnostic tests.  To assure that all
such HCT/P donors are identified:
x
If donor testing was performed in-house by the HCT/P establishment, that establishment
must investigate to determine which donors were so tested and determine which HCT/Ps
currently in inventory are affected, and quarantine them (21 CFR 1271.160(a) and
1271.65); or
x
If donor testing was performed by a laboratory under contract, agreement, or other
arrangement, the laboratory must notify the HCT/P establishments affected
(21 CFR 1271.160(b)(2)(ii)) and the HCT/P establishment must investigate and
determine which donors were so tested and which HCT/Ps currently in inventory are
affected and must quarantine affected HCT/Ps (21 CFR 1271.60(a) and 1271.65).
3

Contains Nonbinding Recommendations
IV. HCT/P DEVIATION REPORTS FOR DISTRIBUTED HCT/PS
A.
Are These Testing Deficiencies Considered HCT/P Deviations and Do They
Relate to Core Current Good Tissue Practice Requirements?
FDA defines an HCT/P deviation in 21 CFR 1271.3(dd) as an event:
1.
That represents a deviation from applicable regulations in 21 CFR Part 1271 or
from applicable standards or established specifications that relate to the
prevention of communicable disease transmission or HCT/P contamination; or
2.
That is an unexpected or unforeseeable event that may relate to the transmission
or potential transmission of a communicable disease or may lead to HCT/P
contamination.
The testing deficiencies described in this guidance meet the definition of an HCT/P
deviation.  Requirements related to donor eligibility determinations, donor screening and
donor testing are core current good tissue practices (CGTPs) (21 CFR 1271.150(b)(10)).
B.
Am I Required to Report an HCT/P Deviation for the HCT/Ps I Distributed?
Under 21 CFR 1271.350(b)(1), you must investigate all HCT/P deviations related to a
distributed HCT/P for which you performed a manufacturing step.  Therefore, the
establishment that performed donor testing must investigate the HCT/P deviations
described in this guidance.
Under 21 CFR 1271.350(b)(2), you must report any such HCT/P deviation relating to a
core CGTP requirement, if the HCT/P deviation occurred in your facility or in a facility
that performed a manufacturing step for you under contract, agreement, or other
arrangement.  Since donor testing is a core CGTP, the establishment that distributed the
HCT/P related to a donor testing deficiency must report these HCT/P deviations, as
follows.
1.
Report an HCT/P deviation for the following distributed HCT/Ps:
x
HPCs and DLIs derived from peripheral or cord blood:
o
For use in first-degree or second-degree blood relatives (related
allogeneic).  These HCT/Ps are regulated solely under section 361 of the
Public Health Service Act (PHS Act).
2.
Do not report an HCT/P deviation for the following distributed HCT/Ps:
x
HPCs and DLIs derived from peripheral or cord blood:
o
For use in unrelated allogeneic recipients.  These HCT/Ps are regulated as
biological products under section 351 of the PHS Act (21 CFR 1271.20).
Section 1271.350 (21 CFR 1271.350) does not apply to HCT/Ps regulated
as biological products (21 CFR 1271.330).
4

Contains Nonbinding Recommendations
ƒ
If under an Investigational New Drug Application (IND), an
information amendment should be submitted directly to the IND file,
as appropriate (21 CFR 312.31).
o
For autologous use.  No HCT/P deviation report is required because
testing of autologous donors is not required for HCT/Ps regulated under
section 361 of the PHS Act (21 CFR 1271.10).
x
Reproductive HCT/Ps, because the HCT/P deviation reporting requirements in
21 CFR 1271.350(b) do not apply to reproductive HCT/Ps.
C.
How Should I Report an HCT/P Deviation?
If an HCT/P deviation report is required for certain distributed HCT/Ps affected by one of
the two testing deficiencies described in this guidance document, you may submit one
HCT/P deviation report for all affected HCT/Ps.  HCT/P deviation reports must be
submitted using Form FDA 3486 (Biological Product Deviation Reports) either
electronically as directed on the web at http://www.fda.gov/cber/biodev.biodev.htm or by
mail to the Director, Office of Compliance and Biologics Quality, Center for Biologics
Evaluation and Research (HFM-600), 1401 Rockville Pike, Suite 200N, Rockville, MD
20852-1448 (21 CFR 1271.350(b)(3)).  Each report must contain a description of the
HCT/P deviation, information relevant to the event and the manufacture of the HCT/P
involved, and information on all follow-up actions that have been or will be taken in
response to the HCT/P deviation (21 CFR 1271.350(b)(2)).
D.
Which Establishment Should Submit the HCT/P Deviation Report?
An establishment must report any HCT/P deviation relating to a core CGTP requirement
for distributed HCT/Ps, if the HCT/P deviation occurred in its facility or in a facility that
performed a manufacturing step (e.g., the testing laboratory) for it under contract,
agreement, or other arrangement.  Accordingly, the establishment that contracted for the
testing, or that performed the testing in-house on the HCT/P it distributed, must report an
HCT/P deviation (21 CFR 1271.350(b)(2)).
V.
MITIGATION OF RISK OF HCT/PS IN INVENTORY
A.
What Should I Do after Quarantining HCT/Ps in Inventory?
If test kits cleared or approved by FDA for diagnostic use were utilized for the original
donor testing, we recommend that when possible, donors should be retested for the
communicable disease agent or disease by using the appropriate FDA-licensed, approved,
or cleared donor screening tests following the manufacturer’s instructions.
5

Contains Nonbinding Recommendations
If pooled NAT testing was performed for the original donor testing, we recommend that
when possible, donors should be retested utilizing the same NAT test, but using an
individual specimen.
6
Whenever  possible, donor specimens used in retesting should be collected within the
time frame specified in 21 CFR 1271.80(b) (i.e., up to 7 days before or after recovery for
a semen or cord blood stem cell donor, or up to 30 days before recovery for a peripheral
blood stem cell or oocyte donor).  If these time frames have already elapsed, you should
still collect and retest a donor specimen from living donors.
B.
Which Donors Should be Retested and May I Distribute These HCT/Ps?
1.
HPC and DLI donors (other than autologous)
7
x
If retesting of the retained donor specimen utilizing a licensed donor screening
test is performed in accordance with the manufacturer’s instructions and found
negative or nonreactive, FDA intends to exercise enforcement discretion
regarding distribution of these HCT/Ps.  Note that in the case of cord blood
stem cells, the donor to be tested is the birth mother.
x
If a new specimen is obtained and testing of the donor is performed in
accordance with the manufacturer’s instructions and found negative or
nonreactive, FDA intends to exercise enforcement discretion regarding
distribution of these HCT/Ps.
x
If retesting of the donor is not feasible (e.g., where a retained specimen is not
available and the donor cannot be located or refuses to be retested), FDA
intends to exercise enforcement discretion regarding the distribution of these
HCT/Ps provided that:
o
The establishment includes in the accompanying records the reason
retesting could not be performed and maintains this information in its
files;
6
If pooled NAT testing was performed for the original donor testing of HPCs and DLIs, we note that two
manufacturers of FDA-licensed NAT tests, Gen-Probe and Roche Molecular Systems, recently submitted
supplements to their respective BLAs to allow for testing of pooled blood specimens from donors of HPCs and
DLIs.  The BLA supplements were recently approved for the following products:  Gen-Probe Procleix HIV-1/HCV
Assay (utilizing pools of up to 16), Roche COBAS AmpliScreen HIV-1 Test (utilizing pools of up to 24), and Roche
COBAS AmpliScreen HCV Test (utilizing pools of up to 24). Therefore, if pooled NAT testing was performed for
the original donor testing of HPCs and DLIs, additional labeling or retesting of donors of HPCs and DLIs who had
originally been tested using pooled specimens with the Gen-Probe and Roche NAT tests is not necessary prior to
distribution of these products, provided that records of the testing are reviewed and the testing was performed in
accordance with the current manufacturer’s instructions that now allow pooled specimens (e.g., pool size and assay
procedure are consistent with current instructions).  If the original testing was not in accordance with the
manufacturer’s instructions that allow pooled specimens, the HPCs and DLIs should only be distributed consistent
with sections V.B.1 and V.C.
7
Note: Additional labeling or retesting of donors of HPCs and DLIs who had originally been tested using pooled
specimens with the Gen-Probe and Roche NAT tests is not necessary prior to distribution of these products,
provided that records of the testing are reviewed and the testing was performed in accordance with the current
manufacturer’s instructions that now allow pooled specimens (e.g., pool size and assay procedure are consistent with
current instructions) in accordance with section V.A.
6

Contains Nonbinding Recommendations
o
The establishment documents that the recipient’s physician was notified of
the results of testing and screening, including the labeling provisions
described in section V.C., below; and
o
The HCT/Ps are labeled in accordance with section V.C., below.
When these inventoried HCT/Ps described above are distributed under this guidance,
we intend to exercise enforcement discretion and do not expect you to submit an
HCT/P deviation report to FDA.
2.
Reproductive HCT/P donors
Sexually intimate partners who donate gametes for use by the intimate couple are not
required to have donor eligibility determinations (21 CFR 1271.90(a)(2)).  However,
directed and anonymous donors of reproductive HCT/Ps are required to be tested
(21 CFR 1271.85(c)).
a.
Cryopreserved embryos created for sexually intimate partners using a third
party gamete donor
x
If retesting of the retained donor specimen is performed in accordance
with the manufacturer’s instructions and found to be negative or
nonreactive, FDA intends to exercise enforcement discretion regarding
distribution of these cryopreserved HCT/Ps.
x
If a new specimen is obtained and testing of the donor is performed in
accordance with the manufacturer’s instructions and found negative or
nonreactive, FDA intends to exercise enforcement discretion regarding
distribution of these HCT/Ps.
x
If retesting of the donor is not feasible (e.g., where a retained specimen is
not available and the donor cannot be located or refuses to be retested),
FDA intends to exercise enforcement discretion regarding the distribution
of these HCT/Ps provided that:
o
The establishment includes in the accompanying records the reason
retesting could not be performed and maintains in its files this
information;
o
The establishment documents that the recipient’s physician was
notified of the results of testing and screening, including the labeling
provisions described in section V.C., below; and
o
The HCT/Ps are labeled in accordance with section V.C., below.
b.
Cryopreserved semen or oocytes from anonymous and directed donors
x
If retesting of the retained donor specimen is performed in accordance
with the manufacturer’s instructions and found to be negative or
nonreactive, FDA intends to exercise enforcement discretion regarding
distribution of these cryopreserved HCT/Ps.
7

Contains Nonbinding Recommendations
x
If a new specimen is obtained and testing of the donor is performed in
accordance with the manufacturer’s instructions and found negative or
nonreactive, FDA intends to exercise enforcement discretion regarding
distribution of these HCT/Ps.
x
If retesting is not feasible, FDA does not intend to exercise enforcement
discretion.  These HCT/Ps must not be distributed (21 CFR 1271.45(c)
and 1271.50).
When these inventoried HCT/Ps described above are distributed under this
guidance, you do not have to submit an HCT/P deviation report to FDA.
Reproductive HCT/P establishments are not currently subject to
21 CFR 1271.350(b) and are not required to submit HCT/P deviation reports.
C.
How Should I Label the HCT/P When I Distribute Them Without Retesting?
HCT/Ps from donors that are distributed without retesting should be labeled with the
statement:  “WARNING: Advise patient of communicable disease risks.”
If NAT testing was performed on pooled samples, not individual samples as specified in
8
the manufacturer’s instructions, you should list the NAT test and result in the summary of
records and add a qualifier that it was “not performed according to the manufacturer’s
instructions.”
If HCT/P donors were tested using tests cleared or approved by FDA for diagnostic use
rather than FDA-licensed donor screening tests, you should list the diagnostic tests
performed and the result in the summary of records, identifying the tests as “diagnostic
tests used, instead of donor screening tests.”
8
For HPCs and DLIs, if the original pooled NAT testing is not confirmed to have been in accordance with the
manufacturer’s instructions that now allow pooled specimens, you should list the NAT test and result of that test in
the summary of records and add a qualifier that it was “not performed according to the manufacturer’s instructions.”
8


[Federal Register Volume 81, Number 184 (Thursday, September 22, 2016)]
[Notices]
[Pages 65380-65383]
[FR Doc No: 2016-22794]

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

DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2016-0002]

Changes in Flood Hazard Determinations

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Final notice.

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

SUMMARY: New or modified Base (1-percent annual chance) Flood
Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA)
boundaries or zone designations, and/or regulatory floodways
(hereinafter referred to as flood hazard determinations) as shown on
the indicated Letter of Map Revision (LOMR) for each of the communities
listed in the table below are finalized. Each LOMR revises the Flood
Insurance Rate Maps (FIRMs), and in some cases the Flood Insurance
Study (FIS) reports, currently in effect for the listed communities.
The flood hazard determinations modified by each LOMR will be used to
calculate flood insurance premium rates for new buildings and their
contents.

DATES: The effective date for each LOMR is indicated in the table
below.

ADDRESSES: Each LOMR is available for inspection at both the respective
Community Map Repository address listed in the table below and online
through the FEMA Map Service Center at www.msc.fema.gov.

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 Map Information
eXchange (FMIX) online at www.floodmaps.fema.gov/fhm/fmx_main.html.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) makes the final flood hazard determinations as shown in the
LOMRs for each community listed in the table below. Notice of these
modified flood hazard determinations has been published in newspapers
of local circulation and 90 days have elapsed since that publication.
The Deputy Associate Administrator for Insurance and Mitigation has
resolved any appeals resulting from this notification.
    The modified flood hazard determinations are made pursuant to
section 206 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.
    For rating purposes, the currently effective community number is
shown and must be used for all new policies and renewals.
    The new or modified flood hazard information is the basis for the
floodplain management measures that the community is required either to
adopt or to show evidence of being already in effect in order to remain
qualified for participation in the National Flood Insurance Program
(NFIP).
    This new or modified flood hazard information, 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.
    This new or modified flood hazard determinations are used to meet
the floodplain management requirements of the NFIP and also are used to
calculate the appropriate flood insurance premium rates for new
buildings, and for the contents in those buildings. The changes in
flood hazard determinations are in accordance with 44 CFR 65.4.
    Interested lessees and owners of real property are encouraged to
review the final flood hazard information available at the address
cited below for each community or online through the FEMA Map Service
Center at www.msc.fema.gov.

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

    Dated: August 18, 2016.
Roy E. Wright,
Deputy Associate Administrator for Insurance and Mitigation, Department
of Homeland Security, Federal Emergency Management Agency.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                            Chief executive officer       Community map                                       Community
         State and county           Location and case No.         of community             repository        Effective date of modification      No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama:
    Coffee (FEMA Docket No.: B-     City of Enterprise     The Honorable Kenneth W.   City Hall, 501 South  July 11, 2016..................       010045
     1618).                          (15-04-A168P).         Boswell, Mayor, City of    Main Street,
                                                            Enterprise, P.O. Box       Enterprise, AL
                                                            311000, Enterprise, AL     36331.
                                                            36330.
    Tuscaloosa (FEMA Docket No.: B- City of Tuscaloosa     The Honorable Walter       Engineering           July 5, 2016...................       010203
     1614).                          (16-04-1952X).         Maddox, Mayor, City of     Department, 2201
                                                            Tuscaloosa, P.O. Box       University
                                                            2089, Tuscaloosa, AL       Boulevard,
                                                            35401.                     Tuscaloosa, AL
                                                                                35401.
Arkansas: Benton (FEMA Docket No.:  Unincorporated areas   The Honorable Robert D.    Planning Department,  July 20, 2016..................       050419
 B-1618).                            of Benton County (15-  Clinard, Benton County     905 Northwest 8th
                                     06-4245P).             Judge, 215 East Central    Street,
                                                            Avenue, Bentonville, AR    Bentonville, AR
                                                            72712.                     72712.
Colorado:
    Boulder (FEMA Docket No.: B-    City of Boulder (15-   The Honorable Suzanne      Planning and          July 22, 2016..................       080024
     1618).                          08-0360P).             Jones, Mayor, City of      Development
                                                            Boulder, P.O. Box 791,     Services
                                                            Boulder, CO 80306.         Department, 1739
                                                                                Broadway Street,
                                                                                Boulder, CO 80302.

    Weld (FEMA Docket No.: B-1618)  City of Greeley (15-   The Honorable Tom Norton,  City Hall, 1000 10th  July 14, 2016..................       080184
                                     08-0573P).             Mayor, City of Greeley,    Street, Greeley, CO
                                                            1000 10th Street,          80631.
                                                            Greeley, CO 80631.
    Weld (FEMA Docket No.: B-1618)  Unincorporated areas   The Honorable Mike         Weld County Planning  July 14, 2016..................       080266
                                     of Weld County (15-    Freeman, Chairman, Weld    and Zoning
                                     08-0573P).             County Board of            Department, 1555
                                                            Commissioners, P.O. Box    North 17th Avenue,
                                                            758, Greeley, CO 80632.    Greeley, CO 80631.
Florida:
    Broward (FEMA Docket No.: B-    City of Fort           The Honorable John P.      Building Services     July 14, 2016..................       125105
     1618).                          Lauderdale (15-04-     Seiler, Mayor, City of     Department, 700
                                     7586P).                Fort Lauderdale, 100       Northwest 19th
                                                            North Andrews Avenue,      Avenue, Plantation,
                                                            8th Floor, Fort            FL 33311.
                                                            Lauderdale, FL 33301.
    Broward (FEMA Docket No.: B-    Unincorporated areas   Ms. Bertha Henry, Broward  Broward County        July 14, 2016..................       125093
     1618).                          of Broward County      County Administrator,      Environmental
                                     (15-04-7586P).         115 South Andrews          Licensing and
                                                            Avenue, Fort Lauderdale,   Building Permitting
                                                            FL 33301.                  Division, 1 North
                                                                                University Drive,
                                                                                Fort Lauderdale, FL
                                                                                33311.
    Bay (FEMA Docket No.: B-1614).  City of Pompano Beach  The Honorable Lamar        Building Inspections  July 7, 2016...................       120055
                                     (15-04-9775P).         Fisher, Mayor, City of     Division, 100 West
                                                            Pompano Beach, 100 West    Atlantic Boulevard,
                                                            Atlantic Boulevard,        Pompano Beach, FL
                                                            Pompano Beach, FL 33060.   33060.
    Indian River (FEMA Docket No.:  City of Vero Beach     The Honorable Jay Kramer,  City Hall, 1053 20th  July 26, 2016..................       120124
     B-1618).                        (16-04-2464P).         Mayor, City of Vero        Place, Vero Beach,
                                                            Beach, 1053 20th Place,    FL 32960.
                                                            Vero Beach, FL 32960.
    Lake (FEMA Docket No.: B-1618)  Unincorporated areas   The Honorable Sean Parks,  Lake County Public    July 25, 2016..................       120421
                                     of Lake County (15-    Chairman, Lake County      Works Department,
                                     04-2425P).             Board of Commissioners,    323 North Sinclair
                                                            P.O. Box 7800, Tavares,    Avenue, Tavares, FL
                                                            FL 32778.                  32778.
    Manatee (FEMA Docket No.: B-    Unincorporated areas   The Honorable Vanessa      Manatee County        July 5, 2016...................       120153
     1614).                          of Manatee County      Baugh, Chair, Manatee      Building and
                                     (16-04-1946X).         County Board of            Development
                                                            Commissioners, P.O. Box    Services
                                                            1000, Bradenton, FL        Department, 1112
                                                            34206.                     Manatee Avenue
                                                                                West, Bradenton, FL
                                                                                34205.
    Miami-Dade (FEMA Docket No.: B- City of Miami (15-04-  The Honorable              Building Department,  July 8, 2016...................       120650
     1614).                          9311P).                Tom[aacute]s P.            444 Southwest 2nd
                                                            Regalado, Mayor, City of   Avenue, 4th Floor,
                                                            Miami, 3500 Pan American   Miami, FL 33130.
                                                            Drive, Miami, FL 33133.
    Miami-Dade (FEMA Docket No.: B- City of Miami (16-04-  The Honorable              Emergency Management  July 29, 2016..................       120650
     1618).                          1012P).                Tom[aacute]s P.            Department, 444
                                                            Regalado, Mayor, City of   Southwest 2nd
                                                            Miami, 3500 Pan American   Avenue, 10th Floor,
                                                            Drive, Miami, FL 33133.    Miami, FL 33130.
    Osceola (FEMA Docket No.: B-    City of Kissimmee (14- The Honorable Jim Swan,    Engineering           July 27, 2016..................       120190
     1618).                          04-A515P).             Mayor, City of             Department, 101
                                                            Kissimmee, 101 Church      Church Street,
                                                            Street, Kissimmee, FL      Kissimmee, FL 34741.
                                                            34741.
    Osceola (FEMA Docket No.: B-    Unincorporated areas   The Honorable Viviana      Osceola County        July 27, 2016..................       120189
     1618).                          of Osceola County      Janer, Chair, Osceola      Stormwater
                                     (14-04-A515P).         County Board of            Department, 1
                                                            Commissioners, 1           Courthouse Square,
                                                            Courthouse Square, Suite   Suite 3100,
                                                            4700, Kissimmee, FL        Kissimmee, FL 34741.
                                                            34741.
    St. Lucie (FEMA Docket No.: B-  City of Fort Pierce    The Honorable Linda        Building Department,  July 26, 2016..................       120286
     1618).                          (16-04-2206P).         Hudson, Mayor, City of     100 North U.S.
                                                            Fort Pierce, 100 North     Highway 1, Fort
                                                            U.S. Highway 1, Fort       Pierce, FL 34950.
                                                            Pierce, FL 34950.
    St. Lucie (FEMA Docket No.: B-  Unincorporated areas   The Honorable Kim          St. Lucie County      July 26, 2016..................       120285
     1618).                          of St. Lucie County    Johnson, Chairman, St.     Planning and
                                     (16-04-2206P).         Lucie County Board of      Development
                                                            Commissioners, 2300        Department, 2300
                                                            Virginia Avenue, Fort      Virginia Avenue,
                                                            Pierce, FL 34982.          Fort Pierce, FL
                                                                                34982.
    Volusia (FEMA Docket No.: B-    City of Orange City    The Honorable Tom          City Hall, 205 East   July 5, 2016...................       120633
     1614).                          (15-04-9264P).         Laputka, Mayor, City of    Graves Avenue,
                                                            Orange City, 205 East      Orange City, FL
                                                            Graves Avenue, Orange      32763.
                                                            City, FL 32763.
Georgia: Chatham (FEMA Docket No.:  City of Pooler (16-04- The Honorable Mike Lamb,   Zoning                July 13, 2016..................       130261
 B-1618).                            1717P).                Mayor, City of Pooler,     Administration
                                                            100 Southwest Highway      Division, 100
                                                            80, Pooler, GA 31322.      Southwest Highway
                                                                                80, Pooler, GA
                                                                                31322.
Kentucky:
    Hardin (FEMA Docket No.: B-     City of Elizabethtown  The Honorable Edna         City Hall, 200 West   July 19, 2016..................       210095
     1618).                          (15-04-9058P).         Berger, Mayor, City of     Dixie Avenue,
                                                            Elizabethtown, P.O. Box    Elizabethtown, KY
                                                            550, Elizabethtown, KY     42701.
                                                            42702.
    Hardin (FEMA Docket No.: B-     Unincorporated areas   The Honorable Harry L.     Hardin County         July 19, 2016..................       210094
     1618).                          of Hardin County (15-  Berry, Hardin County       Planning and
                                     04-9058P).             Judge/Executive, P.O.      Development
                                                            Box 568, Elizabethtown,    Commission, 150
                                                            KY 42702.                  North Provident
                                                                                Way, Suite 225,
                                                                                Elizabethtown, KY
                                                                                42701.
Louisiana: East Baton Rouge (FEMA   City of Central (15-   The Honorable Jr.          Planning and Zoning   July 15, 2016..................       220060
 Docket No.: B-1618).                06-4438P).             Shelton, Mayor, City of    Commission, 6703
                                                            Central, 13421 Hooper      Sullivan Road,
                                                            Road, Suite 9, Central,    Central, LA 70739.
                                                            LA 70818.
Massachusetts:
    Barnstable (FEMA Docket No.: B- Town of Chatham (16-   The Honorable Jeffrey S.   Community             July 8, 2016...................       250004
     1618).                          01-0500P).             Dykens, Chairman, Town     Development
                                                            of Chatham Board of        Department, 261
                                                            Selectmen, 549 Main        George Ryder Road,
                                                            Street, Chatham, MA        Chatham, MA 02633.
                                                            02633.

    Barnstable (FEMA Docket No.: B- Town of Harwich (16-   The Honorable Peter S.     Town Hall, 732 Main   July 8, 2016...................       250008
     1618).                          01-0500P).             Hughes, Chairman, Town     Street, Harwich, MA
                                                            of Harwich Board of        02645.
                                                            Selectmen, 732 Main
                                                            Street, Harwich, MA
                                                            02645.
Mississippi:
    Copiah (FEMA Docket No.: B-     City of Hazlehurst     The Honorable Henry        City Hall, 209 South  July 28, 2016..................       280046
     1618).                          (15-04-7795P).         Banks, Mayor, City of      Extension Street,
                                                            Hazlehurst, 209 South      Hazlehurst, MS
                                                            Extension Street,          39083.
                                                            Hazlehurst, MS 39083.
    Copiah (FEMA Docket No.: B-     Unincorporated areas   The Honorable Perry L.     Copiah County         July 28, 2016..................       280221
     1618).                          of Copiah County (15-  Hood, President, Copiah    Circuit Clerk's
                                     04-7795P).             County Board of            Office, 100
                                                            Supervisors, P.O. Box      Caldwell Street,
                                                            551, Hazlehurst, MS        Hazlehurst, MS
                                                            39083.                     39083.
Montana: Ravalli (FEMA Docket No.:  Unincorporated areas   The Honorable Ray Hawk,    Ravalli County        July 28, 2016..................       300061
 B-1618).                            of Ravalli County      Chairman, Ravalli County   Planning
                                     (16-08-0080P).         Board of Commissioners,    Department, 215
                                                            215 South 4th Street,      South 4th Street,
                                                            Suite A, Hamilton, MT      Suite F, Hamilton,
                                                            59840.                     MT 59840.
New Hampshire: Rockingham (FEMA     Town of Windham (15-   The Honorable Joel         Community             July 14, 2016..................       330144
 Docket No.: B-1618).                01-1350P).             Desilets, Chairman, Town   Development
                                                            of Windham Board of        Department, 3 North
                                                            Selectmen, 3 North         Lowell Road,
                                                            Lowell Road, Windham, NH   Windham, NH 03087.
                                                            03087.
North Carolina: Burke (FEMA Docket  Unincorporated areas   The Honorable Wayne F.     Burke County          Aug. 1, 2016...................       370034
 No.: B-1628).                       of Burke County (15-   Abele, Sr, Chairman,       Community
                                     04-9342P).             Burke County Board of      Development
                                                            Commissioners, P.O. Box    Department, 110
                                                            219, Morganton, NC 28680.  North Green
                                                                                Street,, Morganton,
                                                                                NC 28655.
Oklahoma: Tulsa (FEMA Docket No.:   City of Tulsa (15-06-  The Honorable Dewey        Stormwater Design     July 19, 2016..................       405381
 B-1618).                            0681P).                Bartlett, Jr., Mayor,      Department, 2317
                                                            City of Tulsa, 175 East    South Jackson
                                                            2nd Street, 15th Floor,    Avenue, Suite 302,
                                                            Tulsa, OK 74103.           Tulsa, OK 74103.
Pennsylvania: Delaware (FEMA        Borough of Trainer     The Honorable Frances      Borough Hall, 824     July 13, 2016..................       420437
 Docket No.: B-1618).                (15-03-2447P).         Zalewski, Mayor, Borough   Main Street,
                                                            of Trainer, 824 Main       Trainer, PA 19061.
                                                            Street, Trainer, PA
                                                            19061.
Tennessee:
    Hamblen (FEMA Docket No.: B-    City of Morristown     The Honorable Gary         Community             July 7, 2016...................       470070
     1618).                          (15-04-7679P).         Chesney, Mayor, City of    Development and
                                                            Morristown, 100 West 1st   Planning
                                                            North Street,              Department, 100
                                                            Morristown, TN 37814.      West 1st North
                                                                                Street, Morristown,
                                                                                TN 37814.
    Sequatchie (FEMA Docket No.: B- City of Dunlap (16-04- The Honorable Dwain Land,  City Hall, 15595      July 8, 2016...................       470270
     1628).                          1892P).                Mayor, City of Dunlap,     Rankin Avenue,
                                                            P.O. Box 546, Dunlap, TN   Dunlap, TN 37327.
                                                            37327.
Texas:
    Bexar (FEMA Docket No.: B-      City of San Antonio    The Honorable Ivy R.       Transportation and    July 11, 2016..................       480045
     1618).                          (16-06-0036P).         Taylor, Mayor, City of     Capital
                                                            San Antonio, P.O. Box      Improvements
                                                            839966, San Antonio, TX    Department, Storm
                                                            78283.                     Water Division,
                                                                                1901 South Alamo
                                                                                Street, 2nd Floor,
                                                                                San Antonio, TX
                                                                                78204.
    Bexar (FEMA Docket No.: B-      City of San Antonio    The Honorable Ivy R.       Transportation and    July 15, 2016..................       480045
     1618).                          (16-06-0941P).         Taylor, Mayor, City of     Capital
                                                            San Antonio, P.O. Box      Improvements
                                                            839966, San Antonio, TX    Department, Storm
                                                            78283.                     Water Division,
                                                                                1901 South Alamo
                                                                                Street, 2nd Floor,
                                                                                San Antonio, TX
                                                                                78204.
    Bexar (FEMA Docket No.: B-      Unincorporated areas   The Honorable Nelson W.    Bexar County Public   July 22, 2016..................       480035
     1628).                          of Bexar County (15-   Wolff, Bexar County        Works Department,
                                     06-3161P).             Judge, Paul Elizondo       233 North Pecos-La
                                                            Tower, 101 West Nueva      Trinidad Street,
                                                            Street, 10th Floor, San    Suite 420, San
                                                            Antonio, TX 78205.         Antonio, TX 78207.
    Collin (FEMA Docket No.: B-     City of Frisco (15-06- The Honorable Maher Maso,  Engineering Services  July 11, 2016..................       480134
     1618).                          3867P).                Mayor, City of Frisco,     Department, 6101
                                                            6101 Frisco Square         Frisco Square
                                                            Boulevard, Frisco, TX      Boulevard, 3rd
                                                            75034.                     Floor, Frisco, TX
                                                                                75034.
    Collin (FEMA Docket No.: B-     City of McKinney (15-  The Honorable Brian        Engineering           July 11, 2016..................       480135
     1618).                          06-3643P).             Loughmiller, Mayor, City   Department, 221
                                                            of McKinney, P.O. Box      North Tennessee
                                                            517, McKinney, TX 75070.   Street, McKinney,
                                                                                TX 75069.
    Collin (FEMA Docket No.: B-     City of McKinney (16-  The Honorable Brian        Engineering           July 11, 2016..................       480135
     1618).                          06-0893P).             Loughmiller, Mayor, City   Department, 221
                                                            of McKinney, P.O. Box      North Tennessee
                                                            517, McKinney, TX 75070.   Street, McKinney,
                                                                                TX 75069.
    Collin (FEMA Docket No.: B-     Town of Westminster    Mr. Phil Goplin,           Town Hall, 309 West   June 17, 2016..................       480758
     1628).                          (16-06-0644P).         President, Westminster     Houston Street,
                                                            Special Utility            Westminster, TX
                                                            District, 409 East         75069.
                                                            Houston Street,
                                                            Westminster, TX 75485.
    Collin (FEMA Docket No.: B-     Unincorporated areas   The Honorable Keith Self,  Collin County         June 17, 2016..................       480130
     1628).                          of Collin County (16-  Collin County Judge,       Engineering
                                     06-0644P).             2300 Bloomdale Road,       Department, 4690
                                                            Suite 4192, McKinney, TX   Community Avenue,
                                                            75071.                     Suite 200,
                                                                                McKinney, TX 75071.
    Denton (FEMA Docket No.: B-     City of Fort Worth     The Honorable Betsy        Stormwater            July 1, 2016...................       480596
     1618).                          (15-06-1721P).         Price, Mayor, City of      Management
                                                            Fort Worth, 1000           Division, 1000
                                                            Throckmorton Street,       Throckmorton
                                                            Fort Worth, TX 76102.      Street, Fort Worth,
                                                                                TX 76102.
    Denton (FEMA Docket No.: B-     Town of Northlake (15- The Honorable Peter        Public Works          July 1, 2016...................       480782
     1618).                          06-1721P).             Dewing, Mayor, Town of     Department, 1400 FM
                                                            Northlake, 1400 FM 407,    407, Northlake, TX
                                                            Northlake, TX 76247.       76247.

    Denton (FEMA Docket No.: B-     Town of Trophy Club    The Honorable Nick         Community             July 7, 2016...................       481606
     1614).                          (15-06-3923P).         Sanders, Mayor, Town of    Development
                                                            Trophy Club, 100           Department, 100
                                                            Municipal Drive, Trophy    Municipal Drive,
                                                            Club, TX 76262.            Trophy Club, TX
                                                                                76262.
    Denton (FEMA Docket No.: B-     Unincorporated areas   The Honorable Mary Horn,   Public Works          July 1, 2016...................       480774
     1618).                          of Denton County (15-  Denton County Judge, 110   Engineering
                                     06-1721P).             West Hickory Street, 2nd   Division, 1505 East
                                                            Floor, Denton, TX 76201.   McKinney Street,
                                                                                Suite 175, Denton,
                                                                                TX 76209.
    Denton (FEMA Docket No.: B-     Unincorporated areas   The Honorable Mary Horn,   Denton County Public  July 7, 2016...................       480774
     1614).                          of Denton County (15-  Denton County Judge, 110   Works and Planning
                                     06-3923P).             West Hickory Street, 2nd   Division, 1505 East
                                                            Floor, Denton, TX 76201.   McKinney Street,
                                                                                Suite 175, Denton,
                                                                                TX 76209.
    Lamar (FEMA Docket No.: B-      City of Paris (14-06-  The Honorable AJ Hashmi,   Engineering,          July 11, 2016..................       480427
     1618).                          4102P).                Mayor, City of Paris,      Planning and
                                                            135 Southeast 1st          Development
                                                            Street, Paris, TX 75460.   Department, 135
                                                                                Southeast 1st
                                                                                Street, Paris, TX
                                                                                75460.
    Midland (FEMA Docket No.: B-    City of Midland (15-   The Honorable Jerry        Engineering           July 20, 2016..................       480477
     1618).                          06-4466P).             Morales, Mayor, City of    Department, 300
                                                            Midland, 300 North         North Loraine
                                                            Loraine Street, Midland,   Street, Midland, TX
                                                            TX 79701.                  79701.
    Montgomery (FEMA Docket No.: B- Unincorporated areas   The Honorable Craig        Montgomery County     July 14, 2016..................       480483
     1618).                          of Montgomery County   Doyal, Montgomery County   Engineering
                                     (16-06-0123P).         Judge, 501 North           Department, 501
                                                            Thompson, Suite 401,       North Thompson
                                                            Conroe, TX 77301.          Street, Suite 103,
                                                                                Conroe, TX 77301.
    Parker (FEMA Docket No.: B-     City of Weatherford    The Honorable Dennis       Department of Code    July 20, 2016..................       480522
     1618).                          (15-06-1755P).         Hooks, Mayor, City of      Enforcement, 303
                                                            Weatherford, P.O. Box      Palo Pinto Street,
                                                            255, Weatherford, TX       Weatherford, TX
                                                            76086.                     76086.
    Travis (FEMA Docket No.: B-     City of Austin (15-06- The Honorable Steve        Watershed             July 5, 2016...................       480624
     1618).                          3816P).                Adler, Mayor, City of      Engineering
                                                            Austin, P.O. Box 1088,     Division, 505
                                                            Austin, TX 78767.          Barton Springs
                                                                                Road, 12th Floor,
                                                                                Austin, TX 78767.
    Travis (FEMA Docket No.: B-     City of Pflugerville   The Honorable Jeff         Development Services  July 11, 2016..................       481028
     1614).                          (16-06-0047P).         Coleman, Mayor, City of    Center, 201-B East
                                                            Pflugerville, P.O. Box     Pecan Street,
                                                            589, Pflugerville, TX      Pflugerville, TX
                                                            78691.                     78660.
    Williamson (FEMA Docket No.: B- Unincorporated areas   The Honorable Dan A.       Williamson County     July 7, 2016...................       481079
     1618).                          of Williamson County   Gattis, Williamson         Department of
                                     (15-06-4383P).         County Judge, 710 South    Infrastructure,
                                                            Main Street, Suite 101,    3151 Southeast
                                                            Georgetown, TX 78626.      Inner Loop, Suite
                                                                                B, Georgetown, TX
                                                                                78626.
Utah:
    Utah (FEMA Docket No.: B-1618)  City of Spanish Fork   The Honorable Steve        Engineering           July 8, 2016...................       490241
                                     (15-08-0248P).         Leifson, Mayor, City of    Department, 40
                                                            Spanish Fork, 40 South     South Main Street,
                                                            Main Street, Spanish       Spanish Fork, UT
                                                            Fork, UT 84660.            84660.
    Utah (FEMA Docket No.: B-1618)  Unincorporated areas   The Honorable Larry        Utah County           July 8, 2016...................       495517
                                     of Utah County (15-    Ellertson, Chairman,       Community
                                     08-0248P).             Utah County Board of       Development
                                                            Commissioners, 100 East    Department, 51
                                                            Center Street, Suite       South University
                                                            2300, Provo, UT 84606.     Avenue, Suite 117,
                                                                                Provo, UT 84601.
Virginia:
    Fairfax (FEMA Docket No.: B-    Unincorporated areas   The Honorable Edward L.    Fairfax County        July 1, 2016...................       515525
     1614).                          of Fairfax County      Long, Jr., Fairfax         Stormwater Planning
                                     (15-03-1061P).         County Executive, 12000    Division, 12000
                                                            Government Center          Government Center
                                                            Parkway, Fairfax, VA       Parkway, Suite 449,
                                                            22035.                     Fairfax, VA 22035.
    York (FEMA Docket No.: B-1614)  Unincorporated areas   The Honorable Jeffrey D.   York County           July 1, 2016...................       510182
                                     of York County (16-    Wassmer, Chairman, York    Stormwater
                                     03-0468P).             County Board of            Engineering
                                                            Supervisors, P.O. Box      Division, P.O. Box
                                                            532, Yorktown, VA 23690.   532, Yorktown, VA
                                                                                23690.
--------------------------------------------------------------------------------------------------------------------------------------------------------

[FR Doc. 2016-22794 Filed 9-21-16; 8:45 am]
BILLING CODE 9110-12-P


[Federal Register Volume 84, Number 86 (Friday, May 3, 2019)]
[Proposed Rules]
[Pages 19005-19007]
[FR Doc No: 2019-08975]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R09-OAR-2019-0005; FRL-9993-10-Region 9]

Air Plan Approval; California; Imperial County Air Pollution
Control District

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule.

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

SUMMARY: The Environmental Protection Agency (EPA) is proposing to
approve revisions to the Imperial County Air Pollution Control District
(ICAPCD) portion of the California State Implementation Plan (SIP).
These revisions concern emissions of particulate matter (PM) from open
areas and wood burning appliances and update certain definitions
relevant to stationary source permitting. We are proposing to approve
local rules to regulate these emission sources under the Clean Air Act
(CAA or the Act). We are taking comments on this proposal and plan to
follow with a final action.

DATES: Any comments must arrive by June 3, 2019.

ADDRESSES: Submit your comments, identified by Docket ID No. EPA-R09-
OAR-2019-0005 at https://www.regulations.gov. For comments submitted at
Regulations.gov, follow the online instructions for submitting
comments. Once submitted, comments cannot be edited or removed from
Regulations.gov. The EPA may publish any comment received to its public
docket. Do not submit electronically any information you consider to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Multimedia submissions (audio,
video, etc.) must be accompanied by a written comment. The written
comment is considered the official comment and should include
discussion of all points you wish to make. The EPA will generally not
consider comments or comment contents located outside of the primary
submission (i.e., on the web, cloud, or other file sharing system). For
additional submission methods, please contact the person identified in
the FOR FURTHER INFORMATION CONTACT section. For the full EPA public
comment policy, information about CBI or multimedia submissions, and
general guidance on making effective comments, please visit https://www.epa.gov/dockets/commenting-epa-dockets.

FOR FURTHER INFORMATION CONTACT: Christine Vineyard, EPA Region IX, 75
Hawthorne St., San Francisco, CA 94105. By phone:(415) 947-4125 or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document, ``we,'' ``us'' and
``our'' refer to the EPA.

Table of Contents

I. The State's Submittal
    A. What rules did the State submit?
    B. Are there other versions of these rules?
    C. What is the purpose of the submitted rules?
II. The EPA's Evaluation and Action
    A. How is the EPA evaluating the rules?
    B. Do the rules meet the evaluation criteria?
    C. The EPA's Recommendations To Further Improve the Rules
    D. Public Comment and Proposed Action
III. Incorporation by Reference
IV. Statutory and Executive Order Reviews

I. The State's Submittal

A. What rules did the State submit?

    Table 1 lists the rules addressed by this proposal with the dates
that they were adopted by the ICAPCD and submitted by the California
Air Resources Board (CARB).

                                            Table 1--Submitted Rules
----------------------------------------------------------------------------------------------------------------
                                                                                Adopted/
             Local agency                  Rule No.            Rule title            amended/        Submitted
                                                                                revised
----------------------------------------------------------------------------------------------------------------
ICAPCD................................             101  Definitions.............        09/11/18        10/29/18
ICAPCD................................             428  Wood Burning Appliances         09/11/18        10/29/18
                                                         \1\.
ICAPCD................................             429  Mandatory Episodic              09/11/18        10/29/18
                                                         Curtailment of Wood and
                                                         Other Solid Fuel
                                                         Burning.
ICAPCD................................             804  Open Areas..............        09/11/18        10/29/18
----------------------------------------------------------------------------------------------------------------

    On December 12, 2018, the EPA determined that the submittal for
ICAPCD Rules 101, 428, 429, and 804 met the completeness criteria in 40
CFR part 51 appendix V, which must be met before formal EPA review.
---------------------------------------------------------------------------

    \1\ We are not acting on the opacity in limit in section E.4.2.
of Rule 428 at this time. However, ICAPCD Rule 401, which has been
approved into the California SIP (54 FR 5448 February 3, 1989),
establishes a 20% opacity limit that applies to most sources,
including wood burning appliances. Our action on Rule 428 will not
affect the applicability of this existing limit.
---------------------------------------------------------------------------

B. Are there other versions of these rules?

    There are no previous versions of Rules 428 and 429 in the SIP. We
approved earlier versions of Rules 101 and 804 into the SIP on June 8,
2017 (82 FR 26594) and April 22, 2013 (78 FR 23677), respectively. The
ICAPCD adopted revisions to the SIP-approved versions on September 11,
2018, and CARB submitted them to us on October 29, 2018. The ICAPCD
also previously adopted revisions to 804 on April 12, 2016, and CARB
submitted the revised rule to us on August 22, 2016. We consider this
earlier submittal to have been superseded by the October 29, 2018
submittal. While we are acting on only the most recently submitted
version, we have reviewed materials provided with previous submittals.

C. What is the purpose of the submitted rules and revisions?

    Emissions of PM, including PM equal to or less than 2.5 microns in
diameter (PM2.5) and PM equal to or less than 10 microns in
diameter (PM10), contribute to effects that are harmful to
human health and the environment, including premature mortality,
aggravation of respiratory and cardiovascular disease, decreased lung
function, visibility impairment, and damage to vegetation and
ecosystems. Section 110(a) of the CAA requires states to submit
regulations that control PM emissions.
    New Rule 428 limits emissions of PM from wood burning appliance by
requiring use of only New Source Performance Standard (NSPS) certified
devices or EPA-Qualified fireplaces; restricting the use of burning
materials to seasoned wood, uncolored paper, pellets, and manufactured
logs; and requiring distribution of public awareness information to
educate owners on proper installation, operation, and maintenance of
the wood burning appliance.
    New Rule 429 requires a mandatory wood burning curtailment in
Calexico whenever the ICAPCD forecasts that the 24-hour average
PM2.5 concentration will exceed 35 micrograms per cubic
meter ([micro]g/m\3\) at the Calexico monitoring station. Rule 429 also
includes a contingency measure that will be triggered upon notification
from the EPA that the Imperial County nonattainment area has failed to
(1) meet Reasonable Further Progress in the ``Imperial County 2018
Annual Particulate Matter Less Than 2.5 Microns in Diameter State
Implementation Plan'' (``2018 Annual PM2.5 SIP''), (2) meet
a Quantitative Milestone in the 2018 Annual PM2.5 SIP, and/
or (3) submit a Quantitative Milestone Report required under 40 CFR
51.1013(b). If this occurs, then a mandatory curtailment shall be
declared for all of Imperial County whenever the forecast for the 24-
hour average PM2.5 concentration is equal to or exceeds 30
[micro]g/m\3\ at the Calexico monitoring station.
    Rule 804, Open Areas, was revised to include a provision that would
expand the rule's applicability if contingency measures are triggered.
Another new provision allows for implementation of alternative control
measures in the exposed playa at the Salton Sea, subject to approval by
the ICAPCD and the EPA.
    Four definitions in Rule 101, Definitions, were revised to
correspond to revisions in Rule 207--New and Modified Stationary Source
Review.\2\
---------------------------------------------------------------------------

    \2\ CARB submitted revisions to Rule 207 to the EPA on October
5, 2018. The EPA proposed to approve these revisions on March 22,
2019 (84 FR 10753).
---------------------------------------------------------------------------

    The EPA's technical support documents (TSDs) have more information
about these rules.

II. The EPA's Evaluation and Action

A. How is the EPA evaluating the rules?

    Rules in the SIP must be enforceable (see CAA section 110(a)(2)),
must not interfere with applicable requirements concerning attainment
and reasonable further progress or other CAA requirements (see CAA
section 110(l)), and must not modify certain SIP control requirements
in nonattainment areas without ensuring equivalent or greater emissions
reductions (see CAA section 193).
    The ICAPCD regulates a nonattainment area classified as Moderate
for the 2012 annual PM2.5 standard and Serious for the
annual PM10 standard (40 CFR 81.305). Generally, SIP rules
must implement Best Available Control Measures (BACM) in Serious
PM10 nonattainment areas (see CAA section 189(a)(1)(B)) and
Reasonably Available Control Measures (RACM), including Reasonably
Available Control Technology (RACT), as well as additional reasonable
measures, in Moderate PM2.5 nonattainment areas (see CAA
sections 172(c)(1) and 189(a)(1)(C)). An overall RACM and RACT
evaluation is generally performed in context of a broader plan.
    Guidance and policy documents that we used to evaluate
enforceability, revision/relaxation and rule stringency requirements
for the applicable criteria pollutants include the following:
    1. ``State Implementation Plans; General Preamble for the
Implementation of Title I of the Clean Air Act Amendments of 1990,'' 57
FR 13498 (April 16, 1992); 57 FR 18070 (April 28, 1992).
    2. ``Issues Relating to VOC Regulation Cutpoints, Deficiencies, and
Deviations,'' EPA, May 25, 1988 (the Bluebook, revised January 11,
1990).
    3. ``Guidance Document for Correcting Common VOC & Other Rule
Deficiencies,'' EPA Region 9, August 21, 2001 (the Little Bluebook).
    4. ``State Implementation Plans for Serious PM-10 Nonattainment
Areas, and Attainment Date Waivers for PM-10 Nonattainment Areas
Generally; Addendum to the General Preamble for

the Implementation of Title I of the Clean Air Act Amendments of
1990,'' 59 FR 41998 (August 16, 1994).
    5. ``PM-10 Guideline Document,'' EPA 452/R-93-008, April 1993.
    6. ``Fugitive Dust Background Document and Technical Information
Document for Best Available Control Measures,'' EPA 450/2-92-004,
September 1992.

B. Do the rules meet the evaluation criteria?

    These rules are consistent with CAA and regulatory requirements and
relevant guidance regarding enforceability, BACM, RACM/RACT, and SIP
revisions. EPA's TSDs include more information on our evaluation of the
rules.

C. EPA Recommendations To Further Improve the Rules

    The TSDs include recommendations for the next time the ICAPCD
modifies the rules.

D. Public Comment and Proposed Action

    As authorized in section 110(k)(3) of the Act, the EPA proposes to
fully approve the submitted rules (except for Rule 428 section E.4.2)
because they fulfill all relevant requirements. We will accept comments
from the public on this proposal until June 3, 2019. If we take final
action to approve the submitted rules, our final action will
incorporate these rules into the federally enforceable SIP.

III. Incorporation by Reference

    In this rule, the EPA is proposing to include in a final EPA rule
regulatory text that includes incorporation by reference. In accordance
with requirements of 1 CFR 51.5, the EPA is proposing to incorporate by
reference the ICAPCD rules described in Table 1 of this preamble. The
EPA has made, and will continue to make, these materials available
through www.regulations.gov and at the EPA Region IX Office (please
contact the person identified in the FOR FURTHER INFORMATION CONTACT
section of this preamble for more information).

IV. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the Act and applicable
federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
proposed action merely proposes to approve state law as meeting federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this proposed action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     does not have Federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     is not subject to requirements of Section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the Clean Air Act; and
     does not provide the EPA with the discretionary authority
to address disproportionate human health or environmental effects with
practical, appropriate, and legally permissible methods under Executive
Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter, Reporting
and recordkeeping requirements.

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

    Dated: April 18, 2019.
Deborah Jordan,
Acting Regional Administrator, Region IX.
[FR Doc. 2019-08975 Filed 5-2-19; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register: January 23, 2009 (Volume 74, Number 14)]
[Notices]
[Page 4178]
[DOCID:fr23ja09-41]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2281-011-CA; Project No. 4851-005-CA]

Pacific Gas and Electric Company; Notice of Availability of
Environmental Assessment

January 14, 2009.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's (Commission)
regulations, 18 CFR Part 380 (Order No. 486, 52 FR 47897), the Office
of Energy Projects has reviewed the applications for new licenses for
the Woodleaf-Kanaka Junction and Sly Creek transmission line projects,
located near the South Fork Feather River, in Butte County, California,
and has prepared an environmental assessment (EA) for the projects. The
projects occupy approximately 105 acres, which includes approximately
34 acres that are administered by the Forest Supervisor of the Plumas
National Forest.
    The EA contains staff's analysis of the potential environmental
impacts of the projects and alternatives and concludes that licensing
the projects, with appropriate environmental protective measures, would
not constitute a major federal action that would significantly affect
the quality of the human environment.
    A copy of the EA is available for review at the Commission in the
Public Reference Room or may be viewed on the Commission's Web site at
http://www.ferc.gov using the ``eLibrary'' link. Enter the docket
number excluding the last three digits in the docket number field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,
(202) 502-8659.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    For further information, contact Lesley Kordella at<PHONE_NUMBER>.

Kimberly D. Bose,
Secretary.
[FR Doc. E9-1356 Filed 1-22-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: May 12, 2010 (Volume 75, Number 91)]
[Notices]
[Page 26842-26843]
[DOCID:fr12my10-138]

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

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

Petition for Waiver of Compliance

    In accordance with part 211 of title 49 Code of Federal Regulations
(CFR), notice is hereby given that the Federal Railroad Administration
(FRA) has received a request for a waiver of compliance from certain
requirements of its safety standards. The individual petition is
described below, including the party seeking relief, the regulatory
provisions involved, the nature of the relief being requested, and the
petitioner's arguments in favor of relief.

Metro-North Railroad

[Docket Number FRA-2007-0006]

    The Metro-North Railroad (Metro-North) seeks a permanent waiver of
compliance from certain specific requirements in the testing protocol
of the Locomotive Safety Standards, 49 CFR 229.129(c), as it pertains
to railroad locomotive horn testing. Metro-North seeks to utilize an
acoustic enclosure specifically designed for the purpose of testing
horns removed from the locomotives in lieu of the requirements required
in 229.129(c)(4), (5) & (7). The data from the acoustic enclosure
testing would be used to calculate the level to be expected at the
location 100 feet in front of the locomotive as required under
229.129(c)(7). Metro-North has requested the Acoustical Society of
America to work towards a new American National Standards Institute
(ANSI) standard that supports the approach proposed by Metro-North.
    In addition to the requested waiver of the technical requirements
described above, Metro-North is also requesting an extension of 5 years
to June 24, 2015, in which to complete the required testing of its
approximately 1,098 train horns.
    FRA's Safety Board (Board) did not grant the requested waiver of
the June 24, 2010, deadline as a result of the original waiver
petition. The Board did however invite Metro-North to resubmit that
portion of the waiver request when the outcome of the alternative
testing procedure was known and shown to be acceptable.
    Metro-North has proceeded to fund the design, fabrication and pilot
testing of the testing facility proposed subject to the previously
granted conditional waiver. Metro-North has presented test data from
the testing facility developed under the previous application that
supports the technical validity of the procedure and wishes FRA to
reconsider its application for an extension of 5 years to complete its
efforts to have an ANSI standard adopted and submitted to FRA in
support of its petition, and to complete the testing of its train horns
in accordance with that standard.
    Interested parties are invited to participate in these proceedings
by submitting written views, data, or comments. FRA does not anticipate
scheduling a public hearing in connection with these proceedings since
the facts do not appear to warrant a hearing. If any interested party
desires an opportunity for oral comment, they should notify FRA, in
writing, before the end of the comment period and specify the basis for
their request.
    All communications concerning these proceedings should identify the
appropriate docket number (e.g., Waiver Petition Docket Number FRA-
2007-0006) and may be submitted by any of the following methods:
     Web site: http://www.regulations.gov. Follow the online
instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Operations Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., W12-140, Washington, DC
20590.
     Hand Delivery: 1200 New Jersey Avenue, SE., Room W12-140,
Washington, DC 20590, between 9 a.m. and 5 p.m., Monday through Friday,
except Federal holidays.
    Communications received within 45 days of the date of this notice
will be considered by FRA before final action is taken. Comments
received after that date will be considered as far as

practicable. All written communications concerning these proceedings
are available for examination during regular business hours (9 a.m.--5
p.m.) at the above facility. All documents in the public docket are
also available for inspection and copying on the Internet at the docket
facility's Web site at http://www.regulations.gov.
    Anyone is able to search the electronic form of any written
communications and comments received into any of our dockets by the
name of the individual submitting the document (or signing the
document, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (65 FR 19477) or at
http://www.dot.gov/privacy.html.

    Issued in Washington, DC on May 6, 2010.
Grady C. Cothen, Jr.,
Deputy Associate Administrator for Safety Standards and Program
Development.
[FR Doc. 2010-11206 Filed 5-11-10; 8:45 am]
BILLING CODE 4910-06-P