[Federal Register Volume 83, Number 62 (Friday, March 30, 2018)]
[Rules and Regulations]
[Pages 13632-13637]
[FR Doc No: 2018-06358]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 556, and 558

[Docket No. FDA-2017-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Withdrawal of Approval of New Animal Drug Applications; Changes of
Sponsorship; Change of a Sponsor's Name and Address

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendments.

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

SUMMARY: The Food and Drug Administration (FDA or we) is amending the
animal drug regulations to reflect application-related actions for new
animal drug applications (NADAs) and abbreviated new animal drug
applications (ANADAs) during July, August, and September 2017. FDA is
informing the public of the availability of summaries of the basis of
approval and of environmental review documents, where applicable. The
animal drug regulations are also being amended to reflect the
withdrawal of approval of applications, changes of sponsorship of
applications, and a change of a sponsor's name and address, and to make
technical amendments to improve the accuracy of the regulations.

DATES: This rule is effective March 30, 2018, except for amendatory
instructions 3 to 21 CFR 510.600, 9 to 21 CFR 522.300, 10 to 21 CFR
522.540, and 11 to 21 CFR 522.1081, which are effective April 9, 2018.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during July, August, and September 2017,
as listed in table 1. In addition, FDA is informing the public of the
availability, where applicable, of documentation of environmental
review required under the National Environmental Policy Act (NEPA) and,
for actions requiring review of safety or effectiveness data, summaries
of the basis of approval (FOI Summaries) under the Freedom of
Information Act (FOIA). These public documents may be seen in the
Dockets Management Staff (HFA-305), Food and Drug Administration, 5630
Fishers Lane, Rm. 1061, Rockville, MD 20852, between 9 a.m. and 4 p.m.,
Monday through Friday. Persons with access to the internet may obtain
these documents at the CVM FOIA Electronic Reading Room: https://www.fda.gov/AboutFDA/CentersOffices/OfficeofFoods/CVM/CVMFOIAElectronicReadingRoom/default.htm. Marketing exclusivity and
patent information may be accessed in FDA's publication, Approved
Animal Drug Products Online (Green Book) at: https://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                          Table 1--Original and Supplemental NADAs and ANADAs Approved During July, August, and September 2017
--------------------------------------------------------------------------------------------------------------------------------------------------------
      Approval date        File No.        Sponsor              Product name               Species          Effect of the action     Public  documents
--------------------------------------------------------------------------------------------------------------------------------------------------------
July 21, 2017...........    141-450  Intervet, Inc., 2    BANAMINE Transdermal      Cattle..............  Original approval for    FOI Summary; EA/
                                      Giralda Farms,       (flunixin transdermal                           the control of pyrexia   FONSI.\1\
                                      Madison, NJ 07940.   solution) Solution.                             associated with bovine
                                                                                respiratory disease
                                                                                and the control of
                                                                                pain associated with
                                                                                foot rot in steers,
                                                                                beef heifers, beef
                                                                                cows, beef bulls
                                                                                intended for
                                                                                slaughter, and
                                                                                replacement dairy
                                                                                heifers under 20
                                                                                months of age.

July 19, 2017...........    141-336  ECO LLC, 344 Nassau  AIVLOSIN (tylvalosin      Swine...............  Supplemental approval    FOI Summary.
                                      St., Princeton, NJ   tartrate) Water Soluble                         for control of swine
                                      08540.               Granules.                                       respiratory disease
                                                                                (SRD) associated with
                                                                                Bordetella
                                                                                bronchiseptica,
                                                                                Haemophilus parasuis,
                                                                                Pasteurella multocida,
                                                                                and Streptococcus suis
                                                                                in groups of swine in
                                                                                buildings experiencing
                                                                                an outbreak of SRD.
July 14, 2017...........    200-620  Aurora               ALTREN (altrenogest)      Horses..............  Original approval as a   FOI Summary.
                                      Pharmaceutical,      Solution.                                       generic copy of NADA
                                      LLC, 1196 Highway                                                    131-310.
                                      3 South,
                                      Northfield, MN
                                      55057-3009.
July 14, 2017...........    200-621  Aurora               SWINEMATE (altrenogest)   Swine...............  Original approval as a   FOI Summary.
                                      Pharmaceutical,      Solution.                                       generic copy of NADA
                                      LLC, 1196 Highway                                                    141-222.
                                      3 South,
                                      Northfield, MN
                                      55057-3009.
September 15, 2017......    141-250  Zoetis Inc., 333     Chlortetracycline and     Cattle..............  Supplemental approval    .....................
                                      Portage St.,         lasalocid Type B and                            of revised
                                      Kalamazoo, MI        Type C medicated feeds.                         representative
                                      49007.                                                               labeling making
                                                                                technical amendments.
September 28, 2017......    141-333  Virbac AH, Inc.,     SENTINEL SPECTRUM         Dogs................  Supplemental approval    FOI Summary.
                                      3200 Meacham         (milbemycin oxime/                              for the treatment and
                                      Blvd., Ft. Worth,    lufenuron/praziquantel).                        control of the adult
                                      TX 76137.                                                            tapeworm Dipylidium
                                                                                caninum.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ The Agency has carefully considered an environmental assessment (EA) of the potential environmental impact of this action and has made a finding of
  no significant impact (FONSI).

II. Change of Sponsorship

    SmartVet USA, Inc., 22201 West Innovation Dr., suite 170A, Olathe,
KS 66061-1304 has informed FDA that it has transferred ownership of,
and all rights and interest in, the following application to Sparhawk
Laboratories, Inc., 12340 Santa Fe Trail Dr., Lenexa, KS 66215:

------------------------------------------------------------------------
            File No.                  Product name        21 CFR Section
------------------------------------------------------------------------
200-348........................  ECOMECTIN (ivermectin)        524.1193
                                  Topical Solution.
------------------------------------------------------------------------

Following this withdrawal of approval, SmartVet USA, Inc. is no longer
the sponsor of an approved application. Accordingly, it will be removed
from the list of sponsors of approved applications in Sec.  510.600(c)
(21 CFR 510.600(c)).
    Strategic Veterinary Pharmaceuticals, Inc., 100 NW. Airport Rd.,
St. Joseph, MO 64503 has informed FDA that it has transferred ownership
of, and all rights and interest in, the following application to Cross
Vetpharm Group Ltd., Broomhill Rd., Tallaght, Dublin 24, Ireland:

------------------------------------------------------------------------
            File No.                  Product name        21 CFR Section
------------------------------------------------------------------------
109-305........................  Oxytocin Injection....        522.1680
------------------------------------------------------------------------

The animal drug regulations are being amended to reflect these changes
of sponsorship.

III. Withdrawals of Approval

    The following sponsors requested that FDA withdraw approval of the
NADAs listed in the following table because the products are no longer
manufactured or marketed:

----------------------------------------------------------------------------------------------------------------
              File No.                           Sponsor                    Product name          21 CFR Section
----------------------------------------------------------------------------------------------------------------
047-055.............................  Watson Laboratories, Inc.,    Chorionic Gonadotropin              522.1081
                                       311 Bonnie Circle, Corona,    Powder for Injection.
                                       CA 92880.
104-606.............................  Watson Laboratories, Inc.,    Dexamethasone Sodium                 522.540
                                       311 Bonnie Circle, Corona,    Phosphate Injection.
                                       CA 92880.

139-633.............................  Wildlife Laboratories, Inc.,  WILDNIL (carfentanil                 522.300
                                       1230 W. Ash St., Suite D,     citrate) Injection.
                                       Windsor, CO 80550.
----------------------------------------------------------------------------------------------------------------

    Following this withdrawal of approval, Watson Laboratories, Inc. is
no longer the sponsor of an approved application. Accordingly, it will
be removed from the list of sponsors of approved applications in Sec.
510.600(c).
    Elsewhere in this issue of the Federal Register, FDA gave notice
that approval of NADAs 047-055, 104-606, and 139-633, and all
supplements and amendments thereto, is withdrawn, effective April 9,
2018. As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these actions.

IV. Technical Amendments

    Western Chemical, Inc., 1269 Lattimore Rd., Ferndale, WA 98248 has
informed FDA that it has changed its name and address to Syndel USA,
1441 W. Smith Rd., Ferndale, WA 98248. ADM Alliance Nutrition, Inc.,
1000 North 30th St., Quincy, IL 62305-3115 has informed FDA that it has
changed its name to ADM Animal Nutrition, Inc. Accordingly, we are
amending Sec.  510.600(c) to reflect these changes.
    We are also making technical amendments to update the scientific
name of a pathogenic bacterium, to accurately list the concentrations
of ingredients in a combination new animal drug, and to correctly list
the assay limits and maximum drug concentration in Type B medicated
feeds for a combination new animal drug used in feed. These actions are
being taken to improve the accuracy of the regulations.

V. Legal Authority

    This final rule is issued under section 512(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.360b(i)), which requires
Federal Register publication of ``notice[s] . . . effective as a
regulation,'' of the conditions of use of approved new animal drugs.
This rule sets forth technical amendments to the regulations to codify
recent actions on approved new animal drug applications and corrections
to improve the accuracy of the regulations, and as such does not impose
any burden on regulated entities.
    Although denominated a rule pursuant to the FD&C Act, this document
does not meet the definition of ``rule'' in 5 U.S.C. 804(3)(A) because
it is a ``rule of particular applicability.'' Therefore, it is not
subject to the congressional review requirements in 5 U.S.C. 801-808.
Likewise, this is not a rule subject to Executive Order 12866, which
defines a rule as ``an agency statement of general applicability and
future effect, which the agency intends to have the force and effect of
law, that is designed to implement, interpret, or prescribe law or
policy or to describe the procedure or practice requirements of an
agency.''

List of Subjects

21 CFR Part 510

    Administrative practice and procedure, Animal drugs, Labeling,
Reporting and recordkeeping requirements.

21 CFR Parts 520, 522, and 524

    Animal drugs.

21 CFR Part 556

    Animal drugs, Food.

21 CFR Part 558

    Animal drugs, Animal feeds.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
510, 520, 522, 524, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for part 510 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 351, 352, 353, 360b, 371, 379e.

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the
entries for ``ADM Alliance Nutrition, Inc.'', ``SmartVet USA, Inc.''
and ``Western Chemical, Inc.'', and add entries for ``ADM Animal
Nutrition, Inc.'' and ``Syndel USA'' in alphabetical order; and in the
table in paragraph (c)(2), remove the entry for ``086001'' and revise
the entries for ``012286'' and ``050378'' to read as follows:

Sec.  510.600  Names, addresses, and drug labeler codes of sponsors of
approved applications.

* * * * *
    (c) * * *
    (1) * * *

------------------------------------------------------------------------
                                                           Drug labeler
                  Firm name and address                        code
------------------------------------------------------------------------

                              * * * * * * *
ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy,          012286
 IL 62305-3115..........................................

                              * * * * * * *
Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.......          050378

                              * * * * * * *
------------------------------------------------------------------------

    (2) * * *

--------------------------------------------------------------------------------------------------------------------------------------------------------
             Drug labeler code                                                          Firm name and address
--------------------------------------------------------------------------------------------------------------------------------------------------------

                                                                      * * * * * * *
012286.....................................  ADM Animal Nutrition, Inc., 1000 North 30th St., Quincy, IL 62305-3115.

                                                                      * * * * * * *
050378.....................................  Syndel USA, 1441 W. Smith Rd., Ferndale, WA 98248.

                                                                      * * * * * * *
--------------------------------------------------------------------------------------------------------------------------------------------------------

0
3. Effective April 9, 2018,'' in Sec.  510.600, in the table in
paragraph (c)(1), remove the entry for ``Watson Laboratories, Inc.'';
and in the table in paragraph (c)(2), remove the entry for ``000402''.

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
4. The authority citation for part 520 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.48  [Amended]

0
5. In Sec.  520.48, in paragraph (b), remove ``000061 and 061623'' and
in its place add ``000061, 051072, and 061623''.

Sec.  520.1447  [Amended]

0
6. In Sec.  520.1447, in paragraph (d)(1)(ii), remove ``(Taenia
pisiformis, Echinococcus multilocularis, and E. granulosus)'' and in
its place add ``(Dipylidium caninum, Taenia pisiformis, Echinococcus
multilocularis, and E. granulosus)''.

0
7. In Sec.  520.2645, revise paragraphs (d)(1) and (2) to read as
follows:

Sec.  520.2645  Tylvalosin.

* * * * *
    (d) * * *
    (1) Amount. Administer 50 parts per million (ppm) tylvalosin
continuously in drinking water for 5 consecutive days.
    (2) Indications for use. For control of porcine proliferative
enteropathy (PPE) associated with Lawsonia intracellularis infection in
groups of swine in buildings experiencing an outbreak of PPE; and for
control of swine respiratory disease (SRD) associated with Bordetella
bronchiseptica, Haemophilus parasuis, Pasteurella multocida, and
Streptococcus suis in groups of swine in buildings experiencing an
outbreak of SRD.
* * * * *

PART 522--IMPLANTATION OR INJECTABLE DOSAGE FORM NEW ANIMAL DRUGS

0
8. The authority citation for part 522 continues to read as follows:

    Authority: 21 U.S.C. 360b.

Sec.  522.300  [Removed]

0
9. Effective April 9, 2018, remove Sec.  522.300.

0
10. Effective April 9, 2018, in Sec.  522.540, revise paragraphs (b)(2)
and (c)(2) to read as follows:

Sec.  522.540  Dexamethasone solution.

* * * * *
    (b) * * *
    (2) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
* * * * *
    (c) * * *
    (2) Sponsor. See No. 061623 in Sec.  510.600(c) of this chapter.
* * * * *

Sec.  522.1081  [Amended]

0
11. Effective April 9, 2018, in Sec.  522.1081, in paragraph (b)(1),
remove ``Nos. 000402 and 054771'' and in its place add ``No. 054771''.

Sec.  522.1662a  [Amended]

0
12. In Sec.  522.1662a, in paragraph (h)(3)(ii), remove ``Spherophorus
necrophorus'' and in its place add ``Fusobacterium necrophorum''.

Sec.  522.1680  [Amended]

0
13. In Sec.  522.1680, in paragraph (b), remove ``054628,''.

PART 524--OPHTHALMIC AND TOPICAL DOSAGE FORM NEW ANIMAL DRUGS

0
14. The authority citation for part 524 continues to read as follows:

    Authority: 21 U.S.C. 360b.

0
15. Add Sec.  524.970 to read as follows:

Sec.  524.970  Flunixin.

    (a) Specifications. Each milliliter of solution contains 50
milligrams (mg) flunixin (equivalent to 83 mg flunixin meglumine).
    (b) Sponsor. See No. 000061 in Sec.  510.600(c) of this chapter.
    (c) Related tolerances. See Sec.  556.286 of this chapter.
    (d) Conditions of use--(1) Amount. Apply only once at a dose of 3.3
mg flunixin per kg body weight (1.5 mg/lb; 3 mL per 100 lbs) topically
in a narrow strip along the dorsal midline from the withers to the
tailhead.
    (2) Indications for use. For the control of pyrexia associated with
bovine respiratory disease and the control of pain associated with foot
rot in steers, beef heifers, beef cows, beef bulls intended for
slaughter, and replacement dairy heifers under 20 months of age.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian. Cattle must not be slaughtered
for human consumption within 8 days of the last treatment. Not for use
in female dairy cattle 20 months of age or older, including dry dairy
cows; use in these cattle may cause drug residues in milk and/or in
calves born to these cows or heifers. Not for use in suckling beef
calves, dairy calves, and veal calves. A withdrawal period has not been
established for this product in pre-ruminating calves.

0
16. In Sec.  524.1132, revise paragraph (a) to read as follows:

Sec.  524.1132  Hydrocortisone, miconazole, and gentamicin otic
suspension.

    (a) Specifications. Each milliliter (mL) of suspension contains
1.11 milligrams (mg) hydrocortisone aceponate, 17.4 mg miconazole
nitrate, and 1.5 mg gentamicin (as gentamicin sulfate).
* * * * *

Sec.  524.1193  [Amended]

0
17. In Sec.  524.1193, in paragraph (b)(2), remove ``086001'' and in
its place add ``058005''.

PART 556--TOLERANCES FOR RESIDUES OF NEW ANIMAL DRUGS IN FOOD

0
18. The authority citation for part 556 continues to read as follows:

    Authority:  21 U.S.C. 342, 360b, 371.

Sec.  556.286  [Amended]

0
19. In Sec.  556.286, in paragraph (c), remove ``Sec. Sec.  522.956 and
522.970'' and in its place add ``Sec. Sec.  522.956, 522.970, and
524.970''.

PART 558--NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

0
20. The authority citation for part 558 continues to read as follows:

    Authority: 21 U.S.C. 354, 360b, 360ccc, 360ccc-1, 371.

0
21. In Sec.  558.4, in paragraph (d), in the ``Category II'' table,
revise the row entries for ``Neomycin'' through ``Pyrantel tartrate''
to read as follows:

Sec.  558.4  Requirement of a medicated feed mill license.

* * * * *
    (d) * * *

                                                   Category II
----------------------------------------------------------------------------------------------------------------
                                               Assay limits                                       Assay limits
                    Drug                        percent \1\        Type B maximum (100x)        percent \1\ Type
                                                Type A \1\                                          B/C \2\
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
Neomycin....................................          80-120  20 g/lb (4.4%).................             70-125
Oxytetracycline.............................          80-120  20 g/lb (4.4%).................             65-135
Neomycin sulfate............................          80-120  100 g/lb (22.0%)...............             70-125
Nicarbazin (granular).......................          90-110  5.675 g/lb (1.25%).............      85-115/75-125
Narasin.....................................          90-110  5.675 g/lb (1.25%).............      85-115/75-125
Nicarbazin (powder).........................          98-106  5.675 g/lb (1.25%).............      85-115/80-120
Novobiocin..................................          85-115  17.5 g/lb (3.85%)..............             80-120
Pyrantel tartrate...........................          90-110  36 g/lb (7.9%).................             75-125

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
\1\ Percent of labeled amount.
\2\ Values given represent ranges for either Type B or Type C medicated feeds. For those drugs that have two
  range limits, the first set is for a Type B medicated feed and the second set is for a Type C medicated feed.
  These values (ranges) have been assigned in order to provide for the possibility of dilution of a Type B
  medicated feed with lower assay limits to make a Type C medicated feed.

* * * * *

0
22. In Sec.  558.128, revise paragraphs (e)(3)(vi), (e)(4)(ix), and
(e)(4)(xxvi) to read as follows:

Sec.  558.128  Chlortetracycline.

* * * * *
    (e) * * *
    (3) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in
    Chlortetracycline amount          grams/ton        Indications for use         Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(vi) 10 mg/lb of body weight...  Tiamulin hydrogen   For control of swine    Feed chlortetracycline       058198
                                  fumarate, 35.       dysentery associated    at approximately 400        069254
                                                      with Brachyspira        g/ton of feed,
                                                      (formerly Serpulina     varying with body
                                                      or Treponema)           weight and food
                                                      hyodysenteriae          consumption, to
                                                      susceptible to          provide 10 mg/lb of
                                                      tiamulin and for        body weight. Feed
                                                      treatment of swine      continuously as the
                                                      bacterial enteritis     sole ration for 14
                                                      caused by E. coli and   days. Withdraw
                                                      Salmonella              medicated feed 2 days
                                                      choleraesuis            before slaughter.
                                                      sensitive to            Tiamulin as provided
                                                      chlortetracycline and   by Nos. 058198 or
                                                      treatment of            069254 in Sec.
                                                      bacterial pneumonia     510.600(c) of this
                                                      caused by P.            chapter.
                                                      multocida sensitive
                                                      to chlortetracycline.
----------------------------------------------------------------------------------------------------------------

    (4) * * *

----------------------------------------------------------------------------------------------------------------
                                   Combination in
    Chlortetracycline amount          grams/ton        Indications for use         Limitations         Sponsor
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
(ix) 500 to 4,000 to provide 10  Lasalocid, 30 to    Pasture cattle          Feed continuously on a       054771
 mg/lb of body weight daily.      600.                (slaughter, stocker,    hand-fed basis for
                                                      feeder cattle, dairy    not more than 5 days
                                                      and beef replacement    to provide 10 mg
                                                      heifers): For           chlortetracycline per
                                                      treatment of            lb. body weight per
                                                      bacterial enteritis     day and not less than
                                                      caused by E. coli and   60 mg or more than
                                                      bacterial pneumonia     300 mg lasalocid per
                                                      caused by P.            head per day in at
                                                      multocida organisms     least 1 pound of
                                                      susceptible to          feed. Daily lasalocid
                                                      chlortetracycline;      intakes in excess of
                                                      and for increased       200 mg/head/day in
                                                      rate of weight gain.    pasture cattle have
                                                                              not been shown to be
                                                                              more effective than
                                                                              200 mg lasalocid/head/
                                                                              day. Do not allow
                                                                              horses or other
                                                                              equines access to
                                                                              feeds containing
                                                                              lasalocid. No
                                                                              withdrawal period is
                                                                              required. A
                                                                              withdrawal period has
                                                                              not been established
                                                                              for this product in
                                                                              pre-ruminating
                                                                              calves. Do not use in
                                                                              calves to be
                                                                              processed for veal.
                                                                              See Sec.   558.311(d)
                                                                              of this chapter.
                                                                              Lasalocid as provided
                                                                              by No. 054771 in Sec.
                                                                                510.600(c) of this
                                                                              chapter.

                                                  * * * * * * *
(xxvi) 500 to 4,000 to provide   Lasalocid, 30 to    Cattle weighing up to   Hand feed continuously       054771
 10 mg/head/day.                  181.8.              800 pounds: For the     for not more than 5
                                                      treatment of            days at a rate of 10
                                                      bacterial enteritis     mg chlortetracycline
                                                      caused by E. coli and   and 1 mg lasalocid
                                                      bacterial pneumonia     per 2.2 lb. body
                                                      caused by P.            weight daily to
                                                      multocida susceptible   cattle with a maximum
                                                      to chlortetracycline;   of 360 mg of
                                                      and for the control     lasalocid per head
                                                      of coccidiosis caused   per day. Do not allow
                                                      by Eimeria bovis and    horses or other
                                                      E. zuernii.             equines access to
                                                                              feeds containing
                                                                              lasalocid. No
                                                                              withdrawal period is
                                                                              required. A
                                                                              withdrawal period has
                                                                              not been established
                                                                              for this product in
                                                                              pre-ruminating
                                                                              calves. Do not use in
                                                                              calves to be
                                                                              processed for veal.
                                                                              See Sec.   558.311(d)
                                                                              of this chapter.
                                                                              Lasalocid as provided
                                                                              by No. 054771 in Sec.
                                                                                510.600(c) of this
                                                                              chapter.
----------------------------------------------------------------------------------------------------------------

* * * * *

0
23. In Sec.  558.325, revise paragraph (d)(2) to read as follows:

Sec.  558.325  Lincomycin.

* * * * *
    (d) * * *
    (2) The expiration date of VFDs for lincomycin medicated feeds must
not exceed 6 months from the date of issuance. VFDs for lincomycin
shall not be refilled.
* * * * *

Sec.  558.575  [Amended]

0
24. In Sec.  558.575, in paragraph (e)(2)(ii) remove ``and bacterial
infections due to H. galmaxima,''.

    Dated: March 21, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-06358 Filed 3-29-18; 8:45 am]
 BILLING CODE 4164-01-P


  SEQ CHAPTER \h \r 1 Statement Supporting the Renewal of the
Information

Collection Procedure for Local Planning Requirements

and Facility Emergency Release Notification

1.	IDENTIFICATION OF THE INFORMATION COLLECTION

1(a)	Title of the Information Collection

Emergency Planning and Release Notification Requirements (EPCRA sections
302, 303, and 304) B EPA No. 1395.06.

1(b)	Short Characterization

This information collection request (ICR) was previously approved as OMB
No. 2050-0092 through February 28, 2006, for 212,460 hours.  The
Emergency Planning and Community Right-to-Know Act of 1986 (EPCRA)
established broad emergency planning and facility reporting
requirements.  Section 302 (40 CFR 355.30) requires any facility where
an extremely hazardous substance (EHS) is present in an amount at or in
excess of the threshold planning quantity (TPQ) to notify the state
emergency response commission (SERC) by May 17, 1987.  This activity has
been completed; the section 302 costs and burden hours for this ICR,
therefore, reflect only the estimate of the cost and burden incurred by
those additional facilities who come to have an EHS in excess of the TPQ
during the period covered by this ICR.

Section 303 (40 CFR 355.30) requires local emergency planning committees
(LEPCs) to prepare emergency plans for facilities that have EHSs in
excess of the TPQs in their local planning district.  Facilities are
required to provide local planners with information necessary for the
preparation of emergency plans.  In addition, the facilities are
required to inform LEPCs of any relevant changes in chemical use or
production that may effect the emergency plans.  Section 303 requires
LEPCs to complete their emergency plans by October 17, 1988.  This ICR
therefore reflects the costs attributable to the requirement of annually
updating the local emergency response plans.

Section 304 (40 CFR 355.40) requires facilities to report to SERCs and
LEPCs releases in excess of quantities established by EPA.  Facilities
are required to report releases above the reportable quantity (RQ) of
any EHS or other hazardous substance, as identified under the
Comprehensive Environmental Response, Compensation, and Liability Act of
1980 (CERCLA) section 101.  Notice of release must be given to both the
LEPC and SERC.  In addition, facilities must provide a written follow-up
report providing additional information on the release, its impacts, and
any actions taken in response.

EPA estimates that 76,916 facilities (19,998 manufacturers and 56,918
non-manufacturers) are subject to reporting under EPCRA section 302 and
3,456 SERCs and LEPCs are subject to section 303.  EPA estimates that
approximately 4,443 release notifications are made annually under
section 304.  The total burden to facilities over the three year
information collection period is estimated to be 229,473 hours (76,491
hours annually), at a cost of $11.1 million $(3.7 million annually),
with an associated state and local burden of 320,568 hours (106,856
hours annually), at a cost of $8.1 million (2.7 million annually).  The
combined total annual burden for facilities and state and local agencies
is  183,347 hours at a cost of $6.4 million.  No Agency burden is
estimated in association with this ICR.

2.	NEED FOR AND USE OF THE COLLECTION

2(a)	Need/Authority for the Collection

The authority for these requirements is EPCRA sections 302, 303, and 304
(42 U.S.C. '11002, 11003, and 11004).

Section 302 of EPCRA required the EHS list to be "the same list as the
list published in November 1985 by the Administrator in Appendix A of
the `Chemical Emergency Preparedness Program Interim Guidance'."  The
section further required EPA to "publish an interim final regulation
establishing a threshold planning quantity for each substance on the
list..."  If EPA failed to publish the interim final rule, "the
threshold planning quantity for the substance shall be 2 pounds until
such time as the Administrator publishes regulations establishing a
threshold for the substance."

The interim final rule was published in the Federal Register on November
17, 1986 (51 FR 41570), followed by a final rule published on April 22,
1987 (52 FR 13378).  The EHS list consisted at that time of 406
chemicals, and the TPQs ranged from one pound to ten thousand pounds.
There are currently 355 chemicals on the EHS list.

The EHS list along with the TPQs is used to designate facilities for
initial screening for the local emergency planning process.  Section 303
of EPCRA requires facilities that have to provide the notification under
section 302 to designate a facility coordinator to the LEPC and to
"promptly provide information to [the LEPC] necessary for developing and
implementing the emergency plan."  In this manner, the LEPC determines
the potential scope of a response and, therefore, the amount of effort
necessary for emergency planning.  The LEPC will review its plan
annually and incorporate any changes or additions.  These emergency
plans increase the local response and preparedness capability by
allowing local planners to work with industry in their community, to
determine the level of preparedness necessary for a response if a
release should occur.

Under section 304, respondents are required to notify the LEPC and SERC
of releases of EHSs or hazardous substances (as identified under CERCLA
section 101)  above the reportable quantity.  The purpose of the
reporting is to allow response agencies to determine whether their
assistance is needed in handling the response action.  The facility must
provide a written follow-up report.

2(b)	Practical Utility/Users of the Data

The information provided by facilities under sections 302, 303, and 304
is provided to the SERCs and LEPCs.  Individuals can obtain the
information by contacting the SERCs and LEPCs.  The information provided
under sections 302 and 303 is used to increase the community's level of
preparedness to respond to releases of chemicals in their community.
The information is also made available to the public to allow
individuals to practice their "right-to-know" about the hazards posed by
chemicals in their community.

The information provided under section 304 is the trigger to activate
the community's chemical emergency response system.  The written
follow-up report is to update and clarify the information provided in
the initial call.  It is also made available to the public so that the
community can understand what happened during the release.

3.	NON-DUPLICATION, CONSULTATIONS, AND OTHER COLLECTION CRITERIA

3(a)	Non-Duplication

Currently, there are no federal reporting requirements comparable to
sections 302, 303, and 304 of EPCRA.  Release reporting under CERCLA
section 103 is an emergency notification to the National Response Center
(NRC), while release reporting under section 304 is directly to local
and state entities.  The follow-up report required under section 304 is
also unique.

3(b)	Consultations

	EPA talked with the following representatives of SERCs to obtain
estimates of the number of facilities subject to the rule:

	Ray Dinardo			Carole Dougherty		Steve Mason

	EPA Region 1			EPA Region 3			EPA Region 6

	Martha Wolfe			Ted Mix			Dan Roe

	EPA Region 8			EPA Region 10 			AZ SERC

3(c)	Public Notice

In compliance with the Paperwork Reduction Act (44 U.S.C. 3501 et seq.
), the Agency notified the public through a Federal Register notice on
the re-submission of this ICR on 	September 12, 2005 (70 FR 53793).  EPA
received only one comment.

The commenter raised two issues.  The first issue raised by the
commenter is related to the proposed rule on Administrative Reporting
Exemption for Certain Air Releases of Nox (NO and NO2), October 4, 2005
(70 FR 57813).  Commenter stated that this ICR should be adjusted to
consider the impact of this rule on the regulated community.

EPA recognizes that once the rule is finalized there will be some
reduction in burden to those facilities that fall under the exemption.
Until the rule is finalized, the Agency cannot account for the reduction
in burden in this ICR.

The second issue raised by the commenter was that the Agency did not use
updated wage rates for private industries.  Note that the Agency revised
this ICR by using the wage rates stated in the U. S. Bureau of Labor
Statistics, March 2005 edition.

3(d)	Effects of Less Frequent Collection

The reporting deadlines for sections 302, 303, and 304 are set by
statute.  EPA has no authority to allow less frequent collection.

3(e)	General Guidelines

The collection activities specified in this renewal ICR adhere to the
guidelines specified by OMB.

3(f)	Confidentiality

The respondent may claim specific chemical identities as trade secret in
the notification to LEPC on information for developing and implementing
the emergency response plan, under Section 303(d)(2) and (d)(3).  Such
information must be submitted according to EPCRA sections 322 and 323
(40 CFR Part 350).

All trade secrecy claims submitted to EPA under EPCRA are handled and
stored according to procedures set out in the Manual for Physical
Handling, Security, And Protection of Files Containing Trade Secret
Claims Submitted under Sections 303, 311, 312 and/or 313 of the
Emergency Planning and Community Right-to-Know Act (EPCRA).  These
procedures were developed expressly for EPCRA trade secrecy claims with
the knowledge that these documents are sensitive.  Handling and review
of documents containing EPCRA trade secret information is permitted only
by persons who have obtained formal clearance to access the information
based on a work-related need to engage in these activities.  When not
being processed or reviewed by authorized individuals, the claim
submissions containing trade secret information are stored in restricted
access areas.  To ensure that appropriate handling procedures are
activated and the confidentiality of EPCRA trade secret submissions is
maintained, the Agency attaches a cover sheet to the top of each trade
secret document and otherwise marks the document to clearly identify the
document as EPCRA confidential.

3(g)	Sensitive Questions

The information gathering activities under this renewal ICR do not
involve any sensitive questions.

4.	THE RESPONDENTS AND THE INFORMATION REQUESTED

4(a)	Respondents/NAICS Codes

Sections 302, 303, and 304 are applicable to all facilities that either
have present or release the regulated substances.  These sections apply
to facilities in both the manufacturing and non-manufacturing sectors.
EPCRA, as written, does not apply to federal facilities.  However,
Executive Order 12856 requires all federal agencies to comply with the
law.

	Facilities in the following major group of NAICS codes may be subject
to either or both implementing regulations under EPCRA section 302 and
304.  There may be other facilities covered by these regulations, but
not listed.  Major group that may be subject are:  11 (Agriculture,
Forestry, Fishing and Hunting), 22 (Utilities), 31-33 (Manufacturing),
43 (Wholesale Trade ), 44- 45 (Retail Trade), 48-49 (Transportation and
Warehousing).

4(b)	Information Requested

4(b)(i)	Data Items

Facilities newly subject to section 302 must notify their SERC and LEPC
of their reporting obligation.  Under section 303, the facility must
designate a coordinator and provide "information to (the LEPC) necessary
for developing and implementing the (LEPC's) emergency plan."  The
amount of information necessary to fulfill this requirement is
determined by the facility and the LEPC.  If a facility has very low
likelihood of having a release that would impact the community, the LEPC
would probably require very little information for emergency planning.
However, if the facility is a large chemical plant or is in close
proximity to a populated area, the LEPC most likely will develop
extensive planning (especially if the facility is anticipating an
offsite response).  Information requested for the
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	Names, hazards, quantities, and storage information for hazardous
chemicals on-site;

	Methods and procedures to be followed by facility owners and
operators to respond to a release;

	Description of emergency equipment;

	Methods for determining the occurrence of a release, and the area or
population likely to be affected by the release; and

	Procedures to provide reliable, effective, and timely notification.

LEPCs were required to have their plans completed by October 17, 1988.
Therefore, only facilities newly subject to these requirements would
have to provide this information.  Facilities already subject would only
have to update the LEPC if the information that they have already
provided changes.

Under section 304, respondents are required to notify the LEPC and SERC
of releases of EHSs or hazardous substances (as identified in CERCLA
section 101)  above the reportable quantity.  The notice must include
the following information, to the extent that it is known:

	The chemical name or identity of any substance involved in the
release;

	An indication of whether the substance is on the list of EHSs;

	An estimate of the quantity of any such substance that was released
into the environment;

	The time and duration of the release;

	The medium or media into which the release occurred;

	Any known or anticipated acute or chronic health risks associated
with the emergency and, where appropriate, advice regarding medical
attention necessary for exposed individuals;

	Proper precautions to take as a result of the release, including
evacuation (unless such information is readily available to the
community emergency coordinator pursuant to the emergency plan); and

	The name and telephone number of the person or persons to be
contacted for further information.

The facility must provide a written follow-up report that includes the
information above and any updates.  Also, additional information must be
given:

	Actions taken to respond to and contain the release;

	Any known or anticipated acute or chronic health risks associated
with the release; and

	Where appropriate, advice regarding medical attention necessary for
exposed individuals.

4(b)(ii)	Respondent Activities

To determine if a facility is subject to section 302, the facility would
need to review the EHS list to determine if it has any of the 355
chemicals on-site.  The facility would then need to look at the
inventory of any EHSs it may have on-site and compare it to the TPQ.  If
the facility has an EHS above the TPQ, the facility would need to
contact (preferably in writing) their SERC and LEPC to notify them of
their reporting obligation.

To comply with section 303, the designated facility coordinator would
have to work with the LEPC to ensure that the community has an adequate
plan to respond to emergencies that would involve their facility.
Facility coordinators may be asked to serve as an industry
representative to the LEPC.

To comply with section 304, the facility would need to determine, when
an EHS or a CERCLA hazardous substance is being released, if the
quantity of the chemical released is greater than the reportable
quantity; this information needs to be provided in the initial telephone
notification to the SERC and LEPC. The material safety data sheet (MSDS)
or other information that the facility has would provide the health
risks and medical information, as well as response information.

The written follow-up notice needs to be filed "as soon as practical
after a release." This notice documents and updates the information
provided in the initial notification.  Because the initial notification
should be provided immediately after the discovery of the release, the
written follow-up notice allows the facility more time to determine with
greater precision the information provided in the initial notification.
The facility may include a copy of their own internal report of the
circumstances of the accident.

5.	THE INFORMATION COLLECTED:  AGENCY ACTIVITIES, COLLECTION
METHODOLOGY, AND INFORMATION MANAGEMENT

5(a)	Agency Activities

No information provided under sections 302, 303, and 304 is sent to EPA.
 All of the information is kept at the state or local level.

5(b)	Collection Methodology and Management

EPA does not receive the data; therefore, EPA does not have any special
data collection methodology and management.  However, to assist SERCs
and LEPCs in their information management practices and emergency
planning, EPA and the National Oceanic and Atmospheric Administration
have created the Computer Aided Management of Emergency Operations
(CAMEO) database.

5(c)	Small Entity Flexibility

There are no special allowances made for small businesses in the
regulations for sections 302, 303, and 304.  The burden hours for small
businesses are considered to be smaller than those for large facilities
because of the reduced number of chemicals and processes present at
smaller facilities.

5(d)	Collection Schedule

The frequency of collection for these sections of EPCRA is required by
statute.  Facilities are required to report any relevant changes when
they occur.  Under section 304, releases of EHSs and CERCLA hazardous
substances in excess of the reportable quantity must be reported
"immediately" after the owner/operator has knowledge that they occurred.
 The written follow-up notice is required "as soon as practicable after
the release."

6.	ESTIMATING THE BURDEN AND COST OF COLLECTION

6(a)	Estimating Respondent Burden

EPA estimated the respondent burden hours and costs associated with all
recordkeeping and reporting requirements covered in EPCRA sections 302,
303, and 304.  Unit burden and costs were estimated by labor category
required for each of the tasks performed by facilities under 40 CFR Part
355, and tasks performed by LEPCs and SERCs under 40 CFR Part 355 and 40
CFR Section 300.215.

The previous ICR estimated that 71,400 facilities were subject to the
requirements of EPCRA section 302.  In preparing that ICR, EPA contacted
seven states listed under 3(b) to obtain data on the actual number of
facilities reporting under sections 302 and 303.

In developing this ICR, EPA estimated that 76,916 facilities are subject
to EPCRA 302 notification requirements.  For purposes of comparison, EPA
used a strictly population-based extrapolation and found that 80,664
facilities would be subject to such notification requirements.  In
calculating the facilities number of 76,916 that is employed in this
ICR, EPA used reported regional- and state-level data to determine
missing data for EPA regions IV, V, and VII where such information was
lacking.  The following methodology was used: EPA determined correlating
factors that may demonstrate similarities or dissimilarities in the
number of facilities in different regions.  These included both a
measure of manufacturing per capita (i.e., manufacturing density) and an
assessment of agricultural land use (i.e., agricultural density) for
states and regions.  Using the reported data for each state and region,
EPA gathered population data by state from the 2004 U.S. Census to
determine the ratio of EPCRA facilities per capita (i.e., facilities
density) for both states and regions.  Due to the limited number of
state-level EPCRA facilities data points, EPA determined that a more
accurate conclusion would result by making comparisons at the regional
level (where more data was available).  These comparisons were based
both on manufacturing density and agricultural density to find regions
that were most similar.  Finally, the ratio if EPCRA facilities per
capita was used to extrapolate the total number of such facilities in
the regions lacking data.

EPA estimates that approximately 26 percent of these facilities are
manufacturers (19,998), based on the total estimated number of
manufacturers and non-manufacturers subject to sections 311 and 312.  An
annual growth factor of -.67 percent is applied to the number of
manufacturers to yield an estimated 19,864 manufacturing facilities that
are subject to EPCRA section 302 requirements as of the first year of
the ICR-approval period.  In this ICR, the number of non-manufacturers
is estimated to remain constant, at 56,918 facilities.  These estimates
are used as the basis for calculating the total annual burden and cost
estimates for each of the three years covered by this ICR.  It is
important to note, however, that initial reporting burdens for these
facilities under EPCRA sections 302 are assumed to have occurred and are
not included in this ICR.  This ICR accounts for periodic reporting
activities that apply to all currently regulated facilities.  We do not
expect any new facilities to be in compliance during this ICR period
based on the most recent census data.

The number of notifications under section 304 was based on the number of
reports of hazardous substance releases reported to the National
Response Center in 2004, approximately 4,443.  (This estimate does not
include reports on substances that are not subject to reporting
requirements.)

Exhibit 1 presents the estimated unit burden by labor category required
for each of the tasks performed by facilities under 40 CFR Part 355, and
tasks performed by LEPCs and SERCs under 40 CFR Section 300.215.

Read and Understand Regulations

EPA assumes that only newly regulated facilities incur the cost of
reading and understanding regulations at 40 CFR Part 355.  As explained
above, we do not expect any new facilities to come into compliance in
the period covered by this ICR based on the most recent census data.
Therefore, EPA did not estimate any burden for this activity for new
facilities.  All currently regulated facilities are already familiar
with the regulations and the burden for this activity was estimated in
previous ICRs.

Emergency Planning by Facilities (40 CFR 355.30)

All newly regulated facilities must first determine whether they have at
least a threshold planning quantity of an EHS.  All newly regulated
facilities are required to notify the SERC and designate a facility
representative.

	Because few facilities have significant changes that would affect
emergency planning, EPA estimates that only ten percent of all subject
facilities will be required to inform LEPCs of any changes at the
facility.  In addition, because little information is required from
facilities after the initial submittal, EPA also estimates that only
five percent of all subject facilities will provide additional
information to LEPCs either to develop or implement emergency plans.
The burden associated with providing local governments with updated
information for planning purposes is assumed to be a small percentage of
the initial burden for contributing to planning efforts.  EPA assumes
that a burden of 17.65 hours are incurred per new respondent for
emergency planning.  (See Exhibit 1).

Emergency Release Notification by Facilities (40 CFR 355.40)

The number of annual reportable quantity (RQ) releases based on the
number of CERCLA  hazardous substance releases reported in the National
Response Center for 2004, approximately 4,443.  EPA estimates 90 percent
of RQ releases require notifying LEPCs and SERCs, and 10 percent require
notifying the 911 operator.  All reportable releases require a written
follow-up report.

For a previous ICR, EPA contacted four industries (small to large size,
see Section 3(b) of this document), to determine the actual burden
incurred to comply with initial notification and written follow-up
requirements in Section 304 of EPCRA.  The average estimate from
facilities closely matched to EPA=s estimate.  The burden per respondent
for initial notification is approximately 0.50 hours, for written
follow-up, it is approximately 4.35 hours.

Exhibit 1

Section 302, 303, and 304 Reporting and Recordkeeping Requirements

Estimated Unit Burden and Cost

Annual Hours Burden	Total Hours

	Information Collection Activity

	Legal	Management	Technical	Clerical	Burden	Annual Cost

	EMERGENCY PLANNING (355.30) (Facilities)

Inform LEPC of changes to facility that may affect emergency planning
0.00	0.00	1.00	0.50	1.50	$50

	Provide information to LEPC, as required	0.00	2.00	8.00	1.00	11.00	$527

	EMERGENCY RELEASE NOTIFICATION (355.40) (Facilities)

	Determine if release is an RQ	0.00	0.10	0.10	0.00	0.20	$14

	Notify LEPC and SERC of any RQ release	0.00	0.50	0.00	0.00	0.50	$48

	Develop and submit written follow-up notice	0.50	0.65	2.25	0.95	4.35
$230

	Notify 911 operator of transportation-related releases	0.00	0.25	0.00
0.00	0.25	$24

	EMERGENCY RESPONSE PLANS (300.215) (SERCs, LEPCs, and RRTs)

	Update Emergency Response Plans (LEPCs)	0.00	5.00	15.00	1.00	21.00	$822

	Review Emergency Response Plans (SERCs)	0.00	4.00	12.00	0.00	16.00	$642

	Keep records and make them available to the public	0.00	0.00	0.00	10.00
10.00	$199

Emergency Response Plan Development by SERCs and LEPCs (40 CFR 300.215)

Emergency Response Plans must be reviewed and updated annually.  EPA
estimates that SERCs review all LEPC plans over a three-year period.
There are approximately 3,400 LEPCs. Based on information from LEPCs,
the time required to update plans varies from 4 hours a year to 40 to 60
hours.  To develop an estimate, EPA assumed that the largest 120 LEPCs
would spend 40 hours a year and the smaller LEPCs would spend 20 hours a
year; a weighted average of 21 hours was obtained for the recordkeeping
burden to keep records of all Emergency Response Plans. Similarly, a
weighted average was developed for recordkeeping associated with release
reports. The LEPC with a large concentration of chemical plants
indicated that it spent a month on release notification; the other LEPCs
indicated that this activity took five hours a year at most.  A weighted
average of 10 hours was developed  for the annual burden for each of the
LEPCs (3400) and SERCs (56).

6(b)	Estimating Respondent Costs

Estimating costs to respondents on an annual basis is accomplished by
multiplying the respondent burden estimates for each labor category by
the corresponding labor rate for that category.  Unit costs for each
respondent or activity are then multiplied by the number of respondents
or activities performed on an annual basis to yield a total cost for
each information collection activity in Section 6(d).  These costs are
shown in Exhibit 1.

EPA estimates an hourly respondent labor cost for manufacturing facility
respondents of $129.29 for managerial staff, $39.97 for technical staff,
and $23.38 for clerical staff, including wages and benefits. Hourly
respondent labor costs for non-manufacturing facility respondents are
estimated at $84.26 for managerial staff, $38.78 for technical staff,
and $22.19 for clerical staff.  Legal review is estimated at $116.17 and
$112.49 per hour for manufacturing and non-manufacturing facilities
respectively.  A weighted average was developed based on the percentage
of manufacturing and non-manufacturing facilities.

EPA estimates an hourly respondent labor cost (including overhead) for
LEPCs and SERCs of $40.27 for managerial staff, $40.11 for technical
staff, and $19.89 for clerical staff.

Total burden hours and costs for the first year of the ICR are shown in
Exhibit 2.

Capital and O&M Costs

	Capital costs incurred by state and local agencies were estimated in
the previous ICR.  Capital costs include the cost of space required to
store information in filing cabinets.  Life expectancy for file cabinets
were assumed to be 15 years.  Therefore, the Agency did not develop any
cost for this.

	Operating and maintenance costs are limited to mailing costs.
Facilities are assumed to incur postage costs for the following
activities:

	Providing information to the LEPC as required

	submitting written follow-up notice (assume about 4 pages per report)

	Facilities are expected to incur long distance charges when notifying
SERCs.  This estimate affects notification of the SERC of any RQ
release.  Long distance charges are estimated to be $3.50 per
fifteen-minute call.

	State and local governments are assumed to incur postage costs for the
following activities:

	Submitting Emergency Response Plans for review (SERCs)

	Submitting Emergency Response Plans as requested by SERCs to federal
regional response teams for review

	Postage is estimated to cost $0.37 for a first class letter and $3.10
to submit a LEPC plan (plan is up to 500 pages and weighs up to 5
pounds).

	Operation and maintenance costs are shown in Exhibit 3.

6(c)	Estimating Agency Burden and Cost

EPA estimates no annual Agency burden associated with this ICR.  Only
state and local government entities are required to comply with sections
302, 303, and 304 of EPCRA.

6(d)	Estimating Total Annual Respondent Burden and Costs

Exhibit 2 presents the respondent burden for each information collection
activity and for the sum of all information collection activities
performed by each respondent type.  The total average annual burden to
facility respondents is 76,491 hours at a cost of $3.7 million (or
229,473 hours at a cost of $11.1 million for three years).  The total
average annual respondent burden for state and local governments is
106,856 hours at a cost of $2.7 million (or 320,568 hours at a cost of
$8.1 million for three years).  These burden estimates are summarized in
Exhibit 2.

6(e)	Bottom Line Burden Hours and Cost

	The total burden to facilities over the three year information
collection period is estimated to be 229,473 hours (76,491 hours
annually), at a cost of $11.1 million $(3.7 million annually), with an
associated state and local burden of 320,568 hours (106,856 hours
annually), at a cost of $8.1 million (2.7 million annually).   The
combined total annual burden for facilities and state and local agencies
is 183,347 hours at a cost of $6.4 million.

6(f)	Reasons for Change in Burden

Based on the information received from SERCs/LEPC and the most recent
data from the census, the number of annual respondents increased
slightly from the previous ICR.  The estimated average annual burden to
facilities decreased from 88,188 hours per year under the previous ICR
to 76,491 hours per year under this ICR.  The estimated burden to
affected facilities has declined from the previous ICR because no new
facilities will be subject to the regulations during this ICR period.
Therefore, the burden or costs were not calculated for compliance for
new facilities.  Costs have risen for currently covered facilities
because we used the most recent wage rates (March 2005).  The estimated
average burden for SERCs and LEPCs decreased from 124,272 hours to
106,856 hours because the number of plans reviewed by SERCs annually has
been reduced based on information from states that indicate that the
level of review has declined from the early years of the program.  The O
& M costs in the previous ICR is in error.  This ICR reflects the
correct costs and an increase is noted due to an increase in the number
of respondents.

6(g)	Burden Statement

As explained in the previous sections of this document, EPA do not
expect any new facilities to come into compliance during this ICR
period.  This ICR only covers periodic reporting or updates of
information submitted previously by existing facilities.  The average
reporting burden for a limited number of existing facilities, to inform
the LEPC of any changes at the facility that may affect emergency
planning is 1.50 hours.  The average reporting burden for facilities
reporting releases under 40 CFR 355.40 is estimated to average
approximately 5 hours per release, including the time for determining if
the release is a reportable quantity, notifying the LEPC and SERC, or
the 911 operator, and developing and submitting a written follow-up
notice.  There are no record keeping requirements for facilities under
EPCRA Sections 302-304.  The total burden to facilities over three years
is 229,473 hours at a cost of $11.1 million.

The average burden for emergency planning activities is 21 hours per
plan for LEPCs, and 16 hours per plan for SERCs.  Each SERC and LEPC is
also estimated to incur an annual record keeping burden of 10 hours.
The total burden to LEPC and SERC over three years is 320,568 hours at a
cost of $8.1 million.

Burden means the total time, effort, or financial resources expended by
persons to generate, maintain, retain, or disclose or provide
information to or for a Federal agency.  This includes the time needed
to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to comply
with any previously applicable instructions and requirements; train
personnel to be able to respond to a collection of information; search
data sources; complete and review the collection of information; and
transmit or otherwise disclose the information.  An agency may not
conduct or sponsor, and a person is not required to respond to, a
collection of information unless it displays a currently valid OMB
control number.  The OMB control numbers for EPA's regulations are
listed in 40 CFR part 9 and 48 CFR chapter 15.

	To comment on the Agency's need for this information, the accuracy of
the provided burden estimates, and any suggested methods for minimizing
respondent burden, including the use of automated collection techniques,
EPA has established a public docket for this ICR under Docket ID Number
EPA-HQ-SFUND-2005-0008, which is available for online viewing at
HYPERLINK "http://www.regulations.gov/"  www.regulations.gov , or in
person viewing at the Superfund Docket in the EPA Docket Center
(EPA/DC), EPA West, Room B102, 1301 Constitution Avenue, NW, Washington,
D.C.  The EPA Docket Center Public Reading Room is open from 8:30 a.m.
to 4:30 p.m., Monday through Friday, excluding legal holidays.  The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Superfund Docket is<PHONE_NUMBER>.  An
electronic version of the public docket is available at
www.regulations.gov.  This site can be used to submit or view public
comments, access the index listing of the contents of the public docket,
and to access those documents in the public docket that are available
electronically.  When in the system, select “search,” then key in
the Docket ID Number identified above.  Also, you can send comments to
the Office of Information and Regulatory Affairs, Office of Management
and Budget, 725 17th Street, NW, Washington, D.C. 20503, Attention: Desk
Officer for EPA.  Please include the EPA Docket ID Number
EPA-HQ-SFUND-2005-0008 and OMB Control Number 2050-0092 in any
correspondence.

Exhibit 2

Section 302, 303, and 304 Reporting and Recordkeeping Requirements

Estimated First Year Total Burden and Cost

Number of	Annual Hours Burden	Total Hours

	Information Collection Activity

	Respondents	Legal	Management	Technical	Clerical	Burden	Annual Cost

RULE FAMILIARIZATION (Facilities)

Read and understand regulations at 40 CFR Part 355	0	0	0	0

0	0

Subtotal

	-	-	-	-	-	0	0

EMERGENCY PLANNING (355.30) (Facilities)

Calculate if chemicals meet/exceed TPQ	0	0	0	0	0	0	0

	Notify SERC that facility is subject to emergency planning	0	0	0	0	0	0
0

	Designate facility representative and notify LEPC	0	0	0	0	0	0	0

	Inform LEPC of facility changes that may affect emer. Planning	7,692	0
0	7,692	3,846	11,538	$387,208

	Provide information to LEPC, as required	3,846

7,692	30,768	3,846	42,306	$2,027,420

Subtotal

53,844	$2,414,628

EMERGENCY RELEASE NOTIFICATION (355.40) (Facilities)

Determine if release is an RQ	4,936	0	494	494	0	987	$66,664

	Notify LEPC and SERC of any RQ release	4,443	0	2,222	0	0	2,222	$213,192

	Develop and submit written follow-up notice	4,443	2,222	2,888	9,997
4,221	19,327	$1,020,955

	Notify 911 operator of transportation-related releases	444	0	111	0	0
111	$10,660

Subtotal

22,647	$1,311,472

Total (Facilities)

76,491	$3,726,100

EMERGENCY RESPONSE PLANS (300.215) (SERCs, LEPCs, and RRTs)

	Update Emergency Response Plans (LEPCs)	3,400	0	17,000	51,000	3,400
71,400	$2,797,826

	Review Emergency Response Plans (SERCs)	56	0	224	672	0	896	$35,974

	Keep records and make them available to the public	3,456	0	0	0	34,560
34,560	$687,398

Total (SERCs and  LEPCs)

106,856	$3,521,199

Exhibit 3

Capital/Start-up and O& M Costs

(Annual)

Facilities, SERCs and LEPCs

@

$

@

@

@

@

@

@

@

@

@

$

$

@

$

@

$

@

㐀ۖĀ̊n渃昀ĴЀProvide information to LEPC, as required	--	$1423

Notify LEPC and SERC of any RQ release	--	$13,995

Develop and submit written follow-up notice	--	$1,644

Review Emergency Response Plans 	--	$10,540

Total 	--	$27,602

Exhibit 4

Summary of Total Annual Burden and Cost Estimates

	Burden Hours	Labor	O & M

Facilities	76,491	$3,726,100	$17,062

SERCs and LEPCs	106,856	$2,674,982	$10,540

Total	183,347	$6,401,082	$27,602

 EPA previously estimated that only nine percent of the universe was
manufacturers, based on a ratio of manufacturers to non-manufacturers in
the EPCRA section 311/312 universe.  The number of non-manufacturers,
however, included a large number of facilities that are subject to
311/312 solely because of their production or storage of petroleum
products, which are not subject to section 302.  With these facilities
removed from the non-manufacturing universe of 311/312, the ratio of
manufacturers to the total 311/312 universe is 26 percent.

2 To develop this estimate, EPA reviewed the most recent U.S. Census
data on the number of manufacturing establishments.  The summary data
provided by the Census for changes in the number of manufacturers
between 1997 and 2002 was then calculated using the formula for
compounded annual growth, arriving at an annual growth rate of -.67
percent.  This annual growth rate has been used to determine the current
number of manufacturing facilities.

 U.S. Bureau of Labor Statistics, Employer Cost for Employee
Compensation,  Table 12:  Private Manufacturing and Nonmanufacturing
Industries, March 2005.

 Fringe rate from U.S. Bureau of Labor Statistics, Employer Cost for
Employee Compensation,  Table 4:  State and local Government By
Occupational and Industry Group, March 2005.

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[Federal Register Volume 88, Number 164 (Friday, August 25, 2023)]
[Notices]
[Pages 58290-58292]
[FR Doc No: 2023-18287]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID FEMA-2023-0002]

Changes in Flood Hazard Determinations

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

ACTION: 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.

DATES: Each LOMR was finalized as 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 https://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 protected]; or visit the FEMA Mapping and Insurance
eXchange (FMIX) online at https://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. 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. 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 https://msc.fema.gov.

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

Nicholas A. Shufro,
Deputy Assistant Administrator for Risk Management, Federal Emergency
Management Agency, Department of Homeland Security.

--------------------------------------------------------------------------------------------------------------------------------------------------------
                        Location and case       Chief executive officer of                                                                    Community
  State and county             No.                       community                   Community map repository         Date of modification       No.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Alabama: St. Clair    Unincorporated areas  Stan Bateman, Chair, St. Clair      St. Clair County, Highway           Aug. 11, 2023..........       010290
 (FEMA Docket No.: B-  of St. Clair County   County Board of Commissioners,      Department, 31588 U.S. Highway
 2341).                (23-04-0305P).        165 5th Avenue, Ashville, AL        231, Ashville, AL 35953.
                                             35953.
Colorado:
    Adams (FEMA       City of Northglenn    The Honorable Meredith Leighty,     City Hall, 11701 Community Center   Jul. 28, 2023..........       080257
     Docket No.: B-    (22-08-0327P).        Mayor, City of Northglenn, 11701    Drive, Northglenn, CO 80233.
     2334).                                  Community Center Drive,
                                             Northglenn, CO 80233.
    Adams (FEMA       City of Thornton (22- The Honorable Jan Kulmann, Mayor,   City Hall, 9500 Civic Center        Jul. 28, 2023..........       080007
     Docket No.: B-    08-0327P).            City of Thornton, 9500 Civic        Drive, Thornton, CO 80229.
     2334).                                  Center Drive, Thornton, CO 80229.
    Arapahoe (FEMA    City of Centennial    The Honorable Stephanie Piko,       Southeast Metro Stormwater          Jul. 24, 2023..........       080315
     Docket No.: B-    (21-08-0505P).        Mayor, City of Centennial, 13133    Authority, 7437 South Fairplay
     2341).                                  East Arapahoe Road, Centennial,     Street, Centennial, CO 80112.
                                             CO 80112.

    Arapahoe (FEMA    City of Greenwood     The Honorable George Lantz, Mayor,  City Hall, 6060 South Quebec        Jul. 24, 2023..........       080195
     Docket No.: B-    Village (21-08-       City of Greenwood Village, 6060     Street, Greenwood Village, CO
     2341).            0505P).               South Quebec Street, Greenwood      80111.
                                             Village, CO 80111.
    Arapahoe (FEMA    Unincorporated areas  Carrie Warren-Gully, Chair,         Arapahoe County Public Works and    Jul. 24, 2023..........       080011
     Docket No.: B-    of Arapahoe County    Arapahoe County Board of            Development Department, 6924
     2335).            (21-08-0505P).        Commissioners, 5334 South Prince    South Lima Street, Littleton, CO
                                             Street, Littleton, CO 80120.        80112.
    Denver (FEMA      City and County of    The Honorable Michael B. Hancock,   Department of Transportation and    Jul. 24, 2023..........       080046
     Docket No.: B-    Denver (21-08-        Mayor, City and County of Denver,   Infrastructure, 201 West Colfax
     2335).            0294P).               1437 Bannock Street, Suite 300,     Avenue, Department 608, Denver,
                                             Denver, CO 80202.                   CO 80202.
    Douglas (FEMA     Unincorporated areas  Abe Laydon, Chair, Douglas County   Douglas County Public Works         Jul. 28, 2023..........       080049
     Docket No.: B-    of Douglas County     Board of Commissioners, 100 3rd     Department, Engineering Division,
     2334).            (22-08-0219P).        Street, Castle Rock, CO 80104.      100 3rd Street, Castle Rock, CO
                                                                                80104.
    Weld (FEMA        Town of Johnstown     Matt LeCerf, Town of Johnstown      Town Hall, 450 South Parish         Jul. 28, 2023..........       080250
     Docket No.: B-    (22-08-0435P).        Manager, P.O. Box 609, Johnstown,   Avenue, Johnstown, CO 80534.
     2341).                                  CO 80534.
    Weld (FEMA        Unincorporated areas  Scott James, Chair, Weld County     Weld County Commissioner's Office,  Jul. 28, 2023..........       080266
     Docket No.: B-    of Weld County (22-   Board of Commissioners, P.O. Box    1150 O Street, Greely, CO 80632.
     2341).            08-0435P).            758, Greely, CO 80631.
Florida:
    Hillsborough      City of Plant City    Bill McDaniel, Manager, City of     City Hall, 302 West Reynolds        Jul. 20, 2023..........       120113
     (FEMA Docket      (22-04-3498P).        Plant City, 302 West Reynolds       Street, Plant City, FL 33563.
     No.: B-2335).                           Street, Plant City, FL 33563.
    Hillsborough      City of Tampa (23-04- The Honorable Jane Castor, Mayor,   Planning Department, 1400 North     Jul. 27, 2023..........       120114
     (FEMA Docket      0603P).               City of Tampa, 306 East Jackson     Boulevard, Tampa, FL 33607.
     No.: B-2335).                           Street, Tampa, FL 33602.
    Palm Beach (FEMA  Unincorporated areas  Verdenia C. Baker, Palm Beach       Palm Beach County Planning,         Jul. 24, 2023..........       120192
     Docket No.: B-    of Palm Beach         County Administrator, 301 North     Zoning, and Building Department,
     2335).            County (22-04-        Olive Avenue, Suite 1101, West      2300 North Jog Road, West Palm
                       0127P).               Palm Beach, FL 33401.               Beach, FL 33411.
    Volusia (FEMA     City of Edgewater     The Honorable Diezel DePew, Mayor,  Stormwater Department, 409 Mango    Aug. 4, 2023...........       120308
     Docket No.: B-    (23-04-1432P).        City of Edgewater, P.O. Box 100,    Tree Drive, Edgewater, FL 32132.
     2348).                                  Edgewater, FL 32132.
Maryland: Frederick   Unincorporated areas  Jessica Fitzwater, Frederick        Frederick County Division of        Aug. 4, 2023...........       240027
 (FEMA Docket No.: B-  of Frederick County   County Executive, 12 East Church    Planning and Permitting, 30 North
 2341).                (23-03-0342P).        Street, Frederick, MD 21701.        Market Street, Frederick, MD
                                                                                21701.
Montana: Gallatin     City of Bozeman (22-  Jeff Mihelich, Manager, City of     Engineering Department, 20 East     Jul. 26, 2023..........       300028
 (FEMA Docket No.: B-  08-0557P).            Bozeman, P.O. Box 1230, Bozeman,    Olive Street, 1st Floor, Bozeman,
 2341).                                      MT 59771.                           MT 59715.
North Carolina:       Village of            The Honorable Glenn Bernhard,       Moore County Planning and           Aug. 10, 2023..........       370464
 Moore (FEMA Docket    Whispering Pines      Mayor, Village of Whispering        Inspections Department, 1048
 No.: B-2341).         (22-04-5068P).        Pines, 10 Pine Ridge Drive,         Carriage Oaks Drive, Carthage, NC
                                             Whispering Pines, NC 28327.         28327.
South Carolina:
    Berkeley (FEMA    Town of Moncks        The Honorable Michael A.            Community Development Department,   Jul. 20, 2023..........       450031
     Docket No.: B-    Corner (22-04-        Lockliear, Mayor, Town of Moncks    118 Carolina Avenue, Moncks
     2335).            1920P).               Corner, P.O. Box 700, Moncks        Corner, SC 29461.
                                             Corner, SC 29461.
    Berkeley (FEMA    Unincorporated areas  Johnny Cribb, Supervisor, Berkeley  Berkeley County Building and Codes  Jul. 20, 2023..........       450029
     Docket No.: B-    of Berkeley County    County Council, 1003 North          Enforcement Department, 1003
     2335).            (22-04-1920P).        Highway 52, Moncks Corner, SC       North Highway 52, Moncks Corner,
                                             29461.                              SC 29461.
Tennessee:
    Hamilton (FEMA    City of Collegedale   The Honorable Morty Lloyd, Mayor,   Public Works Department, 9751       Jul. 24, 2023..........       475422
     Docket No.: B-    (22-04-3380P).        City of Collegedale, 4910 Swinyar   Sanborn Drive, Collegedale, TN
     2335).                                  Drive, Collegedale, TN 37315.       37315.
    Hamilton (FEMA    Unincorporated areas  The Honorable Weston Wamp, Mayor,   Hamilton County Public Works        Jul. 24, 2023..........       470071
     Docket No.: B-    of Hamilton County    Hamilton County, 625 Georgia        Division, 4005 Cromwell Road,
     2335).            (22-04-3380P).        Avenue, Collegedale, TN 37402.      Chattanooga, TN 37421.
    Wilson (FEMA      City of Mt. Juliet    The Honorable James Maness, Mayor,  Public Works and Engineering        Aug. 3, 2023...........       470290
     Docket No.: B-    (23-04-1901P).        City of Mt. Juliet, 2425 North      Department, 71 East Hill Street,
     2348).                                  Mt. Juliet Road, Mt. Juliet, TN     Mt. Juliet, TN 37122.
                                             37122.
    Wilson (FEMA      Unincorporated areas  The Honorable Randall Hutto,        Wilson County Planning Department,  Aug. 3, 2023...........       470207
     Docket No.: B-    of Wilson County      Mayor, Wilson County, 228 East      228 East Main Street, Lebanon, TN
     2348).            (23-04-1901P).        Main Street, Lebanon, TN 37087.     37087.
Texas:
    Dallas (FEMA      City of Dallas (23-   The Honorable Eric Johnson, Mayor,  Oak Cliff Municipal Center, 320     Aug. 7, 2023...........       480171
     Docket No.: B-    06-0244P).            City of Dallas, 1500 Marilla        East Jefferson Boulevard, Room
     2348).                                  Street, Room 5EN, Dallas, TX        312, Dallas, TX 75203.
                                             75201.
    Denton (FEMA      City of Denton (22-   The Honorable Gerard Hudspeth,      Development Services Department,    Jul. 31, 2023..........       480194
     Docket No.: B-    06-2546P).            Mayor, City of Denton, 215 East     401 North Elm Street, Denton, TX
     2341).                                  McKinney Street, Denton, TX         76201.
                                             76201.
    Denton (FEMA      City of Denton (23-   The Honorable Gerard Hudspeth,      Capital Projects/Engineering        Jul. 31, 2023..........       480194
     Docket No.: B-    06-0063P).            Mayor, City of Denton, 215 East     Department, 401 North Elm Street,
     2341).                                  McKinney Street, Denton, TX         Denton, TX 76201.
                                             76201.
    Denton (FEMA      City of Fort Worth    The Honorable Mattie Parker,        City Hall, 200 Texas Street, Fort   Aug. 7, 2023...........       480596
     Docket No.: B-    (22-06-1732P).        Mayor, City of Fort Worth, 200      Worth, TX 76102.
     2341).                                  Texas Street, Fort Worth, TX
                                             76102.

    Denton (FEMA      Unincorporated areas  The Honorable Andy Eads, Denton     Denton County Development Services  Jul. 31, 2023..........       480774
     Docket No.: B-    of Denton County      County Judge, 1 Courthouse Drive,   Department, 3900 Morse Street,
     2341).            (23-06-0063P).        Suite 3100, Denton, TX 76208.       Denton, TX 76208.
    Ellis (FEMA       City of Ennis (22-06- The Honorable Angeline L.           Planning, Development and           Aug. 7, 2023...........       480207
     Docket No.: B-    2915P).               Juenemann, Mayor, City of Ennis,    Inspection Department, 108 West
     2341).                                  115 West Brown Street, Ennis, TX    Knox Street, Ennis, TX 75119.
                                             75119.
    Ellis (FEMA       City of Midlothian    Chris Dick, Manager, City of        City Hall, 104 West Avenue E,       Aug. 4, 2023...........       480801
     Docket No.: B-    (22-06-1316P).        Midlothian, 104 West Avenue E,      Midlothian, TX 76065.
     2341).                                  Midlothian, TX 76065.
    Ellis (FEMA       City of Waxahachie    Michael Scott, Manager, City of     City Hall, 401 South Rogers         Aug. 4, 2023...........       480211
     Docket No.: B-    (22-06-1316P).        Waxahachie, 401 South Rogers        Street, Waxahachie, TX 75165.
     2341).                                  Street, Waxahachie, TX 75165.
    Ellis (FEMA       Unincorporated areas  The Honorable Todd Little, Ellis    Ellis County District Court House,  Aug. 4, 2023...........       480798
     Docket No.: B-    of Ellis County (22-  County Judge, 101 West Main         109 South Jackson Street,
     2341).            06-1316P).            Street, Waxahachie, TX 75165.       Waxahachie, TX 75165.
    Harris (FEMA      Unincorporated areas  The Honorable Lina Hidalgo, Harris  Harris County Permits Office, 1111  Jul. 24, 2023..........       480287
     Docket No.: B-    of Harris County      County Judge, 1001 Preston          Fannin Street, 8th Floor,
     2341).            (22-06-0678P).        Street, Suite 911, Houston, TX      Houston, TX 77002.
                                             77002.
    Harris (FEMA      Unincorporated areas  The Honorable Lina Hidalgo, Harris  Harris County Permits Office, 1111  Jul. 24, 2023..........       480287
     Docket No.: B-    of Harris County      County Judge, 1001 Preston          Fannin Street, 8th Floor,
     2341).            (22-06-2197P).        Street, Suite 911, Houston, TX      Houston, TX 77002.
                                             77002.
    Tarrant (FEMA     City of Fort Worth    The Honorable Mattie Parker,        Transportation and Public Works     Jul. 20, 2023..........       480596
     Docket No.: B-    (22-06-2617P).        Mayor, City of Fort Worth, 200      Department, Engineering Vault,
     2335).                                  Texas Street, Fort Worth, TX        200 Texas Street, Fort Worth, TX
                                             76102.                              76102.
    Tarrant (FEMA     City of Keller (22-   The Honorable Armin R. Mizani,      Town Hall, 1100 Bear Creek          Jul. 24, 2023..........       480602
     Docket No.: B-    06-2447P).            Mayor, City of Keller, P.O. Box     Parkway, Keller, TX 76248.
     2335).                                  770, Keller, TX 76244.
Virginia: Loudoun     Unincorporated areas  Tim Hemstreet, Loudoun County       Loudoun County Government Center,   Jul. 31, 2023..........       510090
 (FEMA Docket No.: B-  of Loudoun County     Administrator, P.O. Box 7000,       1 Harrison Street Southeast, 3rd
 2341).                (22-03-0882P).        Leesburg, VA 20175.                 Floor, MSC #60, Leesburg, VA
                                                                                20175.
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[FR Doc. 2023-18287 Filed 8-24-23; 8:45 am]
BILLING CODE 9110-12-P