[Federal Register Volume 81, Number 61 (Wednesday, March 30, 2016)]
[Rules and Regulations]
[Pages 17604-17610]
[FR Doc No: 2016-07135]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 510, 520, 522, 524, 528, 529, 556, and 558

[Docket No. FDA-2015-N-0002]

New Animal Drugs; Approval of New Animal Drug Applications;
Changes of Sponsorship

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule; technical amendment.

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SUMMARY: The Food and Drug Administration (FDA) 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 November and December 2015. FDA is also 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 changes of sponsorship of
applications that occurred in November and December 2015.

DATES: This rule is effective March 30, 2016.

FOR FURTHER INFORMATION CONTACT: George K. Haibel, Center for
Veterinary Medicine (HFV-6), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Approval Actions

    FDA is amending the animal drug regulations to reflect approval
actions for NADAs and ANADAs during November and December 2015, 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
Division of Dockets Management (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: http://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: http://www.fda.gov/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/default.htm.

                             Table 1--Original and Supplemental NADAs and ANADAs Approved During November and December 2015
--------------------------------------------------------------------------------------------------------------------------------------------------------
         File No.                   Sponsor                 Product name                 Action           21 CFR Section   FOIA Summary     NEPA Review
--------------------------------------------------------------------------------------------------------------------------------------------------------
141-453..................  Alexion Pharmaceuticals,   hLAL rDNA construct in    Original approval for           528.2010  yes...........  EA/
                            Inc., 33 Hayden Ave.,      SBC LAL-C chickens.       expression of a human                                    FONSI \1\
                            Lexington, MA 02421.                                 gene for recombinant
                                                                                human lysosomal acid
                                                                                lipase (rhLAL) protein
                                                                                in chicken egg whites.
141-456..................  Orion Corp., Orionintie    SILEO (dexmedetomidine    Original approval for            529.539  yes...........  CE \2\ \3\
                            1, 02200 Espoo, Finland.   oromucosal gel).          the treatment of noise
                                                                                aversion in dogs.
141-246..................  Intervet, Inc., 556        AQUAFLOR (florfenicol)    Supplemental approval of        556.283,  no............  CE \2\ \4\
                            Morris Ave., Summit, NJ    Type A medicated          revised representative          558.261
                            07901.                     article.                  labeling for Type C
                                                                                medicated feeds;
                                                                                technical amendments
                                                                                revising the expiration
                                                                                of veterinary feed
                                                                                directives (VFDs) and
                                                                                the description of
                                                                                tolerances for fish.

141-258..................  Intervet, Inc., 556        ZILMAX (zilpaterol        Supplemental approval of         556.765  yes...........  CE \2\ \4\
                            Morris Ave., Summit, NJ    hydrochloride) Type A     a cattle muscle
                            07901.                     medicated article.        tolerance and of new
                                                                                determinative and
                                                                                confirmatory procedures
                                                                                for residues of
                                                                                zilpaterol in cattle
                                                                                liver and muscle.
141-361..................  Elanco Animal Health, A    PULMOTIL AC (tilmicosin   Supplemental approval           520.2471  yes...........  EA/
                            Division of Eli Lilly &    phosphate) Concentrate    for the control of                                       FONSI \1\
                            Co., Lilly Corporate       Solution.                 swine respiratory
                            Center, Indianapolis, IN                             disease associated with
                            46285.                                               Mycoplasma
                                                                                hyopneumoniae in the
                                                                                presence of Porcine
                                                                                Reproductive and
                                                                                Respiratory Syndrome
                                                                                Virus (PRRSV).
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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).
\2\ The Agency has determined that this action is categorically excluded (CE) from the requirement to submit an environmental assessment or an
  environmental impact statement because it is of a type that does not have a significant effect on the human environment.
\3\ CE granted under 21 CFR 25.33(d)(1).
\4\ CE granted under 21 CFR 25.33(a)(1).

II. Changes of Sponsorship

    Bayer HealthCare LLC, Animal Health Division, P.O. Box 390, Shawnee
Mission, KS 66201 (Bayer) has informed FDA that it has transferred
ownership of, and all rights and interest in, the following approved
applications to Cronus Pharma LLC, 2 Tower Center Blvd., Suite 1101,
East Brunswick, NJ 08816:

------------------------------------------------------------------------
           File No.                 Product name        21 CFR section
------------------------------------------------------------------------
055-002......................  TEVCOSIN               522.390
                                (chloramphenicol)
                                Injectable Solution.
094-170......................  Phenylbutazone         520.1720a
                                Tablets, USP 100 mg
                                and 200 mg.
123-815......................  Dexamethasone Sodium   522.540
                                Phosphate Injection.
141-245......................  TRIBUTAME              522.810
                                (chloroquine
                                phosphate,
                                embutramid,
                                lidocaine)
                                Euthanasia Solution.
200-178......................  Amikacin Sulfate       522.56
                                Injection, 50 mg/mL.
200-193......................  Clindamycin            520.447
                                Hydrochloride Oral
                                Liquid.
200-248......................  Pyrantel Pamoate       520.2043
                                Suspension; 2.27 and
                                4.54 mg.
200-265......................  Praziquantel Tablets.  520.1870
200-287......................  GBC (Gentamicin        524.1044g
                                Sulfate
                                Betamethasone
                                Valerate
                                Clotrimazole)
                                Ointment.
200-297......................  Ivermectin Chewable    520.1193
                                Tablets.
200-298......................  Clindamycin            520.446
                                Hydrochloride
                                Capsules.
200-365......................  ROBINUL-V              522.1066
                                (glycopyrrolate)
                                Injectable Solution.
200-382......................  Furosemide Syrup 1%..  520.1010
------------------------------------------------------------------------

    Bayer has also informed FDA that it has transferred ownership of,
and all rights and interest in, approved ANADA 200-342 for Pyrantel
Pamoate Paste to Farnam Companies, Inc., 301 West Osborn Rd., Phoenix,
AZ 85013-3928.
    Boehringer Ingelheim Vetmedica, Inc., 2621 North Belt Hwy., St.
Joseph, MO 64506-2002 has informed FDA that it has transferred
ownership of, and all rights and interest in, the following approved
applications to Huvepharma AD, 5th Floor, 3A Nikolay Haitov Str., 1113
Sofia, Bulgaria:

------------------------------------------------------------------------
           File No.                 Product name        21 CFR section
------------------------------------------------------------------------
006-084 \1\..................  SULMET                 520.2261a
                                (sulfamethazine)
                                Drinking Water
                                Solution.
008-774......................  SULMET                 522.2260
                                (sulfamethazine)
                                Injectable Solution.
033-373 \1\..................  VETSULID               520.2200
                                (sulfachlorpyridazin
                                e).
040-181 \1\..................  VETSULID               520.2200
                                (sulfachlorpyridazin
                                e) Oral Suspension.
055-012 \1\..................  CHLORONEX SULMET       520.445
                                (chlortetracycline
                                bisulfate/
                                sulfamethazine
                                bisulfate) Soluble
                                Powder.
055-018 \1\..................  AUREOMYCIN             520.443
                                (chlortetracycline
                                HCl) Tablets 25 mg.
055-039 \1\..................  AUREOMYCIN             520.443
                                (chlortetracycline
                                HCl) Soluble Oblets.
065-071 \1\..................  AUREOMYCIN             520.441
                                (chlortetracycline
                                HCl) Soluble Powder.
065-269 \1\..................  POLYOTIC               520.2345d
                                (tetracycline
                                hydrochloride)
                                Soluble Powder.
065-440 \1\..................  CHLORONEX              520.441
                                (chlortetracycline
                                HCl or
                                chlortetracycline
                                bisulfate) Soluble
                                Powder.
122-271 \1\..................  SULMET                 520.2260a
                                (sulfamethazine)
                                Oblets.
122-272 \1\..................  SULMET                 520.2261b
                                (sulfamethazine
                                sodium) Soluble
                                Powder.
------------------------------------------------------------------------
\1\ These NADAs were identified as being affected by guidance for
  industry #213, ``New Animal Drugs and New Animal Drug Combination
  Products Administered in or on Medicated Feed or Drinking Water of
  Food-Producing Animals: Recommendations for Drug Sponsors for
  Voluntarily Aligning Product Use Conditions with GFI #209,'' December
  2013.

    In addition, Novartis Animal Health US, Inc., 3200 Northline Ave.,
suite 300, Greensboro, NC 27408 (Novartis) has informed FDA that it has
transferred ownership of, and all rights and interest in, the following
approved applications to Elanco US, Inc., 2500 Innovation Way,
Greenfield, IN 46140.

------------------------------------------------------------------------
           File No.                           Product name
------------------------------------------------------------------------
134-644......................  DENAGARD (tiamulin) Soluble Powder.
139-472......................  DENAGARD (tiamulin) Type B Medicated
                                Feed.
140-915......................  INTERCEPTOR (milbemycin oxime) Tablets.
140-916......................  DENAGARD (tiamulin) Liquid Concentrate.
141-011......................  DENAGARD (tiamulin) plus CTC
                                (chlortetracycline).
141-026......................  PROGRAM (lufenuron) Suspension.
141-029......................  PERCORTEN-V (desoxycorticosterone
                                pivalate) Injectable Suspension.
141-035......................  PROGRAM (lufenuron).
141-062......................  PROGRAM (lufenuron) Cat Flavor Tabs.
141-084......................  SENTINEL (lufenuron and milbemycin oxime)
                                Flavor Tabs.
141-105......................  PROGRAM (lufenuron) 6-Month Injectable
                                for Cats.
141-120......................  CLOMICALM (clomipramine) Tablets.
141-163......................  MILBEMITE (milbemycin oxime) Otic
                                Solution.
141-175......................  CAPSTAR (nitenpyram) Tablets.
141-203......................  DERAMAXX (deracoxib) Chewable Tablets.
141-204......................  SENTINEL Flavor Tabs and CAPSTAR Flea
                                Management System.
141-205......................  PROGRAM Flavor Tabs and CAPSTAR Flea
                                Management System.
141-218......................  ATOPICA (cyclosporine) Capsules.
141-320......................  ONSIOR (robenacoxib) Tablets.
141-329......................  ATOPICA (cyclosporine) Oral Solution for
                                Cats.
141-333......................  SENTINEL SPECTRUM (milbemycin oxime,
                                lufenuron, praziquantel) Chewable
                                Tablets.
141-338......................  INTERCEPTOR SPECTRUM (milbemycin oxime
                                and praziquantel) Chewable Tablets.
141-437......................  OSURNIA (florfenicol, betamethasone
                                acetate, and terbinafine) Otic Gel.
141-443......................  ONSIOR (robenacoxib) Injection.
200-517......................  ZOBUXA (enrofloxacin) Tablets.
200-519......................  FLORVIO (florfenicol) 2.3% Concentrate
                                Solution.
------------------------------------------------------------------------

    As provided in the regulatory text of this document, the animal
drug regulations are amended to reflect these changes of sponsorship.
Elanco US, Inc., is retaining Novartis' drug labeler code (058198).
Accordingly, the animal drug regulations need only be amended in Sec.
510.600(c) to add Elanco US, Inc., who previously was not the sponsor
of an approved application. Cronus Pharma LLC will also be added as a
new listing. Following these changes of sponsorship, Novartis is no
longer the sponsor of an approved application and will be removed from
Sec.  510.600(c).

III. Technical Amendments

    FDA has noticed the animal drug regulations in 21 CFR part 556
contain tolerances for residues in edible tissues for sulfathiazole,
which is no longer the subject of an approved application (79 FR 15540,
March 20, 2014). Accordingly, Sec.  556.690 is being removed. FDA has
also noticed that the animal drug regulations in 21 CFR 558.4 (Sec.
558.4) contain assay limits for ronnel and sulfaethoxypyridazine in
medicated feed. As there is no longer an approved application for use
of either of these drugs in medicated feed, the table for Category II
drugs in Sec.  558.4 is being amended to remove assay limits in
medicated feed for both drugs. These actions are being taken to improve
the accuracy of the regulations.
    In addition, FDA is taking this opportunity to revise the spelling
of a bacitracin salt to a preferred form, bacitracin
methylenedisalicylate, and to correct the spelling of a genus of
pathogenic bacteria, Haemophilus. These actions are being taken to
improve the accuracy of the regulations.
    This rule 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.

List of Subjects

21 CFR Part 510

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

21 CFR Parts 520, 522, 524, 528, and 529

    Animal drugs.

21 CFR Part 556

    Animal drugs, Foods.

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 and
redelegated to the Center for Veterinary Medicine, 21 CFR parts 510,
520, 522, 524, 528, 529, 556, and 558 are amended as follows:

PART 510--NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 510 continues to read as
follows:

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

Sec.  510.600  [Amended]

0
2. In Sec.  510.600, in the table in paragraph (c)(1), remove the entry
for ``Novartis Animal Health US, Inc.'' and add entries for ``Cronus
Pharma LLC'' and ``Elanco US, Inc.'' in alphabetical order; and in the
table in paragraph (c)(2), revise the entry for ``058198'' and add an
entry for ``069043'' in numerical order to read as follows:

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

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

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

                              * * * * * * *
Cronus Pharma LLC, 2 Tower Center Blvd.,    069043
 Suite 1101, East Brunswick, NJ 08816.

                              * * * * * * *
Elanco US, Inc., 2500 Innovation Way,       058198
 Greenfield, IN 46140.

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

    (2) * * *

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

                              * * * * * * *
058198............................  Elanco US, Inc., 2500 Innovation
                                     Way, Greenfield, IN 46140

                              * * * * * * *
069043............................  Cronus Pharma LLC, 2 Tower Center
                                     Blvd., Suite 1101, East Brunswick,
                                     NJ 08816

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

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
3. The authority citation for 21 CFR part 520 continues to read as
follows:

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

Sec.  520.88b  [Amended]

0
4. In Sec.  520.88b, in paragraph (b)(1)(ii)(B), remove ``Hemophilus''
and in its place add ``Haemophilus''.
0
5. In Sec.  520.154b:
0
a. Revise the section heading.
0
b. In paragraph (a), remove ``methylene disalicylate'' and in its place
add ``methylenedisalicylate''.
    The revision reads as follows:

Sec.  520.154b  Bacitracin methylenedisalicylate and streptomycin
sulfate powder.

* * * * *

Sec.  520.441  [Amended]

0
6. In Sec.  520.441, in paragraphs (b)(2) and (d)(4)(iii)(C), remove
``000010'' and in its place add ``016592''; and in in paragraphs
(d)(1)(i)(A)(1), (d)(2)(i)(A)(1), (d)(4)(iii)(B), and (d)(4)(iv)(B),
remove ``Hemophilus'' and in its place add ``Haemophilus''.

Sec.  520.443  [Amended]

0
7. In Sec.  520.443, in paragraph (b), remove ``No. 054628'' and in its
place add ``Nos. 016592 and 054628''; and in paragraphs (d)(1)(i),
(d)(2)(i), and (d)(3)(i), remove ``Hemophilus'' and in its place add
``Haemophilus''.

Sec.  520.445  [Amended]

0
8. In Sec.  520.445, in paragraph (b), remove ``000010'' and in its
place add ``016592''.

Sec.  520.446  [Amended]

0
9. In Sec.  520.446, in paragraph (b)(1), remove ``No. 054771'' and in
its place add ``Nos. 054771 and 069043''.

Sec.  520.447  [Amended]

0
10. In Sec.  520.447, in paragraph (b), remove ``Nos. 000859, 051311,
054771, 058829, and 061623'' and in its place add ``Nos. 051311,
054771, 058829, 061623, and 069043''.

Sec.  520.823  [Amended]

0
11. In Sec.  520.823, in paragraph (d)(2)(ii), remove ``Hemophilus''
and in its place add ``Haemophilus''.

Sec.  520.1010  [Amended]

0
12. In Sec.  520.1010, in paragraph (b)(3), remove ``Nos. 000859 and
058829'' and in its place add ``Nos. 058829 and 069043''.

Sec.  520.1193  [Amended]

0
13. In Sec.  520.1193, in paragraph (b)(2), remove ``Nos. 000859 and
051311'' and in its place add ``Nos. 051311 and 069043''.

Sec.  520.1720a  [Amended]

0
14. In Sec.  520.1720a, in paragraph (b)(2), remove ``Nos. 000859 and
054628'' and in its place add ``Nos. 054628 and 069043''.
0
15. In Sec.  520.1870, revise paragraph (b) to read as follows:

Sec.  520.1870  Praziquantel tablets.

* * * * *
    (b) Sponsor. See No. 069043 in Sec.  510.600(c) of this chapter for
use of the product described in paragraph (a)(1) of this section as in
paragraph (c)(1) of this section; and for use of the product described
in paragraph (a)(2) of this section as in paragraph (c)(2) of this
section.
* * * * *

Sec.  520.2043  [Amended]

0
16. In Sec.  520.2043, in paragraph (b)(1), remove ``Nos. 000859,
054771, and 058829'' and in its place add ``Nos. 054771, 058829, and
069043''.

Sec.  520.2044  [Amended]

0
17. In Sec.  520.2044, in paragraph (b)(2), remove ``000859'' and in
its place add ``017135''.

Sec.  520.2200  [Amended]

0
18. In Sec.  520.2200, in paragraph (b), remove ``000010'' and in its
place add ``016592''.

Sec.  520.2260a  [Amended]

0
19. In Sec.  520.2260a, in paragraph (a)(1), remove ``000010'' and in
its place add ``016592''.

Sec.  520.2261a  [Amended]

0
20. In Sec.  520.2261a, in paragraph (b), remove ``000010'' and in its
place add ``016592''.

Sec.  520.2261b  [Amended]

0
21. In Sec.  520.2261b, in paragraph (b), remove ``000010'' and in its
place add ``016592''.

Sec.  520.2345d  [Amended]

0
22. In Sec.  520.2345d, in paragraphs (b)(5), (d)(1)(iii), and
(d)(2)(iii), remove ``000010'' and in its place add ``016592''; and in
paragraphs (d)(1)(ii) and (d)(2)(ii), remove ``Hemophilus'' and in its
place add ``Haemophilus''.

0
23. In Sec.  520.2471, revise paragraph (d)(2) to read as follows:

Sec.  520.2471  Tilmicosin.

* * * * *
    (d) * * *
    (2) Indications for use--(i) For the control of swine respiratory
disease associated with Pasteurella multocida and Haemophilus parasuis
in groups of swine in buildings where a respiratory disease outbreak is
diagnosed.
    (ii) For the control of swine respiratory disease associated with
Mycoplasma hyopneumoniae in the presence of Porcine Reproductive and
Respiratory Syndrome Virus (PRRSV) in groups of swine in buildings
where a respiratory disease outbreak is diagnosed.
* * * * *

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

0
24. The authority citation for 21 CFR part 522 continues to read as
follows:

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

Sec.  522.56  [Amended]

0
25. In Sec.  522.56, in paragraph (b), remove ``000859'' and in its
place add ``069043''.

Sec.  522.390  [Amended]

0
26. In Sec.  522.390, in paragraph (b), remove ``Nos. 000859 and
054771'' and in its place add ``Nos. 054771 and 069043''.

Sec.  522.540  [Amended]

0
27. In Sec.  522.540, in paragraph (e)(2), remove ``000859'' and in its
place add ``069043''.

Sec.  522.810  [Amended]

0
28. In Sec.  522.810, in paragraph (b), remove ``000859'' and in its
place add ``069043''.

Sec.  522.1066  [Amended]

0
29. In Sec.  522.1066, in paragraph (b), remove ``Nos. 000859 and
054771'' and in its place add ``Nos. 054771 and 069043''.

Sec.  522.1662a  [Amended]

0
30. In Sec.  520.1662a, in paragraphs (b)(3)(i)(b), (c)(3)(i),
(d)(3)(i)(a), (e)(3)(i)(b), (g)(3)(i)(b), and (k)(3)(ii), remove
``Hemophilus'' and in its place add ``Haemophilus''.

Sec.  522.2260  [Amended]

0
31. In Sec.  522.2260, in paragraph (b), remove ``000010'' and in its
place add ``016592''.

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

0
32. The authority citation for 21 CFR part 524 continues to read as
follows:

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

Sec.  524.1044g  [Amended]

0
33. In Sec.  522.1044g, in paragraph (b)(3), remove ``000859'' and in
its place add ``069043''.

PART 528--NEW ANIMAL DRUGS IN GENETICALLY ENGINEERED ANIMALS

0
34. The authority citation for 21 CFR part 528 continues to read as
follows:

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

0
35. Add Sec.  528.2010 to read as follows:

Sec.  528.2010  Human lysosomal acid lipase recombinant
deoxyribonucleic acid construct.

    (a) Specifications. A single copy of a human lysosomal acid lipase
(hLAL) recombinant deoxyribonucleic acid (rDNA) gene construct located
at the SYN LAL-C site in chromosome 6 in a specific, diploid line (SBC
LAL-C) of hemizygous and homozygous domestic chickens (Gallus gallus),
derived from the lineage progenitor XLL 109.
    (b) Sponsor. See No. 069334 in Sec.  510.600 of this chapter.
    (c) Conditions of use--(1) Intended use. The gene construct directs
the expression of that encoding gene such that recombinant, human
lysosomal acid lipase (rhLAL) protein intended for the treatment of
human disease is present in SBC LAL-C chicken egg whites.
    (2) Limitations. Food or feed from XLL 109 chickens is not
permitted in the food or feed supply.

PART 529--CERTAIN OTHER DOSAGE FORM NEW ANIMAL DRUGS

0
36. The authority citation for 21 CFR part 529 continues to read as
follows:

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

0
37. Add Sec.  529.539 to read as follows:

Sec.  529.539  Dexmedetomidine.

    (a) Specifications. Each milliliter of gel contains 0.09 milligrams
(mg) dexmedetomidine (equivalent to 0.1 mg dexmedetomidine
hydrochloride).
    (b) Sponsor. See No. 052483 in Sec.  510.600(c) of this chapter.
    (c) Conditions of use--(1) Amount. Administer onto the oral mucosa
between the dog's cheek and gum at a dose of 125 micrograms per square
meter.
    (2) Indications for use. For the treatment of noise aversion in
dogs.
    (3) Limitations. Federal law restricts this drug to use by or on
the order of a licensed veterinarian.

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

0
38. The authority citation for 21 CFR part 556 continues to read as
follows:

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

0
39. In Sec.  556.70, in paragraph (b), remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''; and add
paragraph (c) to read as follows:

Sec.  556.70  Bacitracin.

* * * * *
    (c) Related conditions of use. See Sec. Sec.  520.154a, 520.154c,
558.76, and 558.78 of this chapter.
0
40. In Sec.  556.283, revise paragraphs (b)(3) and (4) to read as
follows:

Sec.  556.283  Florfenicol.

* * * * *
    (b) * * *
    (3) Freshwater-reared finfish (other than catfish) and salmonids.
The tolerance for florfenicol amine (the marker residue) in muscle/skin
(the target tissues) is 1 ppm.
    (4) Catfish. The tolerance for florfenicol amine (the marker
residue) in muscle (the target tissues) is 1 ppm.
* * * * *

Sec.  556.690  [Removed]

0
41. Remove Sec.  556.690.
0
42. In Sec.  556.765, revise paragraph (b)(1)(i) and add paragraphs
(b)(1)(ii) and (c) to read as follows:

Sec.  556.765  Zilpaterol.

* * * * *
    (b) * * *
    (1) * * *
    (i) Liver (the target tissue). The tolerance for zilpaterol (the
marker residue) is 12 parts per billion (ppb).
    (ii) Muscle. The tolerance for zilpaterol (the marker residue) is
10 ppb.
* * * * *
    (c) Related conditions of use. See Sec.  558.665 of this chapter.

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

0
43. The authority citation for 21 CFR part 558 continues to read as
follows:

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

Sec.  558.4  [Amended]

0
44. In Sec.  558.4, in paragraph (d), in the ``Category I'' table, in
the ``Drug''

column, remove ``Bacitracin methylene disalicylate'' and in its place
add '' Bacitracin methylenedisalicylate''; and in the ``Category II''
table, remove the entries for ``Ronnel'' and ``Sulfaethoxypyridazine''.

Sec.  558.55  [Amended]

0
45. In Sec.  558.55, in paragraph (d)(2)(ii), in the ``Combination in
grams per ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.

Sec.  558.58  [Amended]

0
46. In Sec.  558.58, in paragraph (e)(4), in the ``Limitations''
column, remove ``methylene disalicylate'' and in its place add
``methylenedisalicylate''.

Sec.  558.68  [Amended]

0
47. In Sec.  558.68, remove paragraph (e)(3).
0
48. In Sec.  558.76, remove paragraph (e)(2), redesignate paragraph
(e)(3) as paragraph (e)(2), and revise redesignated paragraph (e)(2) to
read as follows:

Sec.  558.76  Bacitracin methylenedisalicylate.

* * * * *
    (e) * * *
    (2) Bacitracin methylenedisalicylate may also be used in
combination with:
    (i) Amprolium as in Sec.  558.55.
    (ii) Amprolium and ethopabate as in Sec.  558.58.
    (iii) Clopidol as in Sec.  558.175.
    (iv) Decoquinate as in Sec.  558.195.
    (v) Diclazuril as in Sec.  558.198.
    (vi) Fenbendazole as in Sec.  588.258.
    (vii) Halofuginone hydrobromide as in Sec.  558.265.
    (viii) Ivermectin as in Sec.  558.300.
    (ix) Lasalocid as in Sec.  558.311.
    (x) Monensin as in Sec.  588.355.
    (xi) Narasin as in Sec.  558.363.
    (xii) Nicarbazin alone and with narasin as in Sec.  558.366.
    (xiii) Robenidine as in Sec.  558.515.
    (xiv) Salinomycin as in Sec.  558.550.
    (xv) Semduramicin as in Sec.  558.555.
    (xvi) Zoalene as in Sec.  558.680.

Sec.  558.128  [Amended]

0
49. In Sec.  558.128, in paragraph (e)(7)(ii), remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.

Sec.  558.175  [Amended]

0
50. In Sec.  558.175, in paragraph (d)(2), in the ``Combination in
grams per ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.

Sec.  558.195  [Amended]

0
51. In Sec.  558.195, in paragraph (e)(1)(ii), in the ``Combination in
grams/ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.

Sec.  558.198  [Amended]

0
52. In Sec.  558.198, in paragraphs (d)(1)(ii) and (d)(2)(ii), in the
``Combination grams/ton'' and ``Limitations'' columns, remove
``methylene disalicylate'' and in its place add
``methylenedisalicylate''.

Sec.  558.258  [Amended]

0
53. In Sec.  588.258, in paragraphs (e)(2)(vi) and (vii), in the
``Combination in grams per ton'' and ``Limitations'' columns, remove
``methylene disalicylate'' and in its place add
``methylenedisalicylate''.
0
54. In Sec.  558.261, redesignate paragraphs (c)(2)(i) and (ii) as
paragraphs (c)(2)(ii) and (i), respectively, revise redesignated
paragraph (c)(2)(ii), and add paragraph (c)(4) to read as follows:

Sec.  558.261  Florfenicol.

* * * * *
    (c) * * *
    (2) * * *
    (ii) For fish must not exceed 6 months from the date of issuance.
* * * * *
    (4) Type A medicated articles and medicated feeds intended for use
in fish shall bear the following: ``Not for use in animals intended for
breeding purposes. The effects of florfenicol on reproductive
performance have not been determined. Toxicity studies in dogs, rats,
and mice have associated the use of florfenicol with testicular
degeneration and atrophy.''
* * * * *

Sec.  558.265  [Amended]

0
55. In Sec.  558.265, in paragraphs (d)(1)(vi) and (d)(2)(ii), remove
``methylene disalicylate'' and in its place add
``methylenedisalicylate''.

Sec.  558.300  [Amended]

0
56. In Sec.  558.300, in paragraphs (e)(2) and (3), in the
``Combination in g/ton of feed'' column, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''; and in
paragraph (e)(9), in the ``Combination in g/ton of feed '' and
``Limitations'' columns, remove ``methylene disalicylate'' and in its
place add ``methylenedisalicylate''.

Sec.  558.311  [Amended]

0
57. In Sec.  558.311, in paragraphs (e)(1)(iv) and (x), in the
``Limitations'' column, remove ``methylene disalicylate'' and in its
place add ``methylenedisalicylate''; and in paragraph (e)(1)(xv), in
the ``Combination in grams per ton'' and ``Limitations'' columns,
remove ``methylene disalicylate'' and in its place add
``methylenedisalicylate''.

Sec.  558.355  [Amended]

0
58. In Sec.  558.355, in paragraphs (f)(1)(iii)(b), (f)(1)(xxiv),
(f)(1)(xxix) introductory text, (f)(1)(xxix)(b), (f)(1)(xxx)
introductory text, (f)(1)(xxx)(b), (f)(2)(ii) introductory text,
(f)(2)(ii)(b), (f)(2)(iii) introductory text, (f)(2)(iii)(a),
(f)(2)(iii)(b), (f)(4)(ii) introductory text, (f)(4)(ii)(b),
(f)(4)(iii) introductory text, (f)(4)(iii)(b), (f)(4)(v) introductory
text, and (f)(4)(v)(b), remove ``methylene disalicylate'' and in its
place add ``methylenedisalicylate''.

Sec.  558.363  [Amended]

0
59. In Sec.  558.363, in paragraphs (d)(1)(iv) introductory text,
(d)(1)(iv)(B), and (d)(3)(ii), remove ``methylene disalicylate'' and in
its place add ``methylenedisalicylate''.

Sec.  558.366  [Amended]

0
60. In Sec.  558.366, in paragraph (d), in the ``Combination in grams
per ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' wherever it occurs and in its place add
``methylenedisalicylate''.

Sec.  558.450  [Amended]

0
61. In Sec.  558.450, in paragraph (d)(5)(v), in the ``Indications for
Use'' column, remove ``Hemophilus'' and in its place add
``Haemophilus''.

Sec.  558.515  [Amended]

0
62. In Sec.  558.515, in paragraph (d), in the ``Combination in grams
per ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' wherever it occurs and in its place add
``methylenedisalicylate''.

Sec.  558.550  [Amended]

0
63. In Sec.  558.550, in paragraphs (d)(1)(iii)(a), (d)(1)(iii)(c),
(d)(1)(vi)(a), (d)(1)(xx)(A), (d)(1)(xx)(C), (d)(1)(xxi)(A),
(d)(1)(xxi)(C), (d)(3)(ii) introductory text, (d)(3)(ii)(B),
(d)(3)(iii) introductory text, (d)(3)(iii)(B), (d)(3)(v) introductory
text, and (d)(3)(v)(B), remove ``methylene disalicylate'' and in its
place add ``methylenedisalicylate''; and in paragraph (d)(1)(vi)(c),
remove ``Bacitracin MD'' and in its place add ``Bacitracin
methylenedisalicylate''.

Sec.  558.555  [Amended]

0
64. In Sec.  558.555, in paragraph (d)(2), in the ``Combination in
grams per ton'' and ``Limitations'' columns, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.

Sec.  558.680  [Amended]

0
65. In Sec.  558.680, in paragraphs (d)(1)(ii), (iii), (iv), (vi),
(vii), and (viii) in the ``Combination in grams per ton'' and
``Limitations'' columns, remove ``methylene disalicylate'' and in its
place add ``methylenedisalicylate''; and in paragraph (d)(2)(ii), in
the ``Combination in grams per ton'' column, remove ``methylene
disalicylate'' and in its place add ``methylenedisalicylate''.

    Dated: March 25, 2016.
Tracey H. Forfa,
Deputy Director, Center for Veterinary Medicine.
[FR Doc. 2016-07135 Filed 3-29-16; 8:45 am]
 BILLING CODE 4161-01-P


[Federal Register Volume 84, Number 44 (Wednesday, March 6, 2019)]
[Notices]
[Pages 8132-8137]
[FR Doc No: 2019-03989]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-85222; File No. SR-MSRB-2019-04]

Self-Regulatory Organizations; Municipal Securities Rulemaking
Board; Notice of Filing and Immediate Effectiveness of a Proposed Rule
Change Consisting of Interpretive Guidance About Frequently Asked
Questions Regarding the Use of Social Media Under the MSRB's
Advertising Rules

February 28, 2019.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on February 26, 2019 the Municipal Securities Rulemaking Board
(``MSRB'') filed with the Securities and Exchange Commission (``SEC''
or ``Commission'') the proposed rule change as described in Items I,
II, and III below, which Items have been prepared by the MSRB. The
Commission is publishing this notice to solicit comments on the
proposed rule change from interested persons.
---------------------------------------------------------------------------

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

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

    The MSRB filed with the Commission a proposed rule change
consisting of interpretive guidance about frequently asked questions
regarding the use of social media under MSRB Rule G-21, on advertising
by brokers, dealers and municipal securities dealers, and MSRB Rule G-
40, on advertising by municipal advisors (Rule G-21, together with Rule
G-40, the ``advertising rules''). The proposed rule change has been
filed for immediate effectiveness under Section 19(b)(3)(A) of the
Exchange Act \3\ and Rule 19b-4(f)(6) thereunder.\4\ The effective date
of the amendments to Rule G-21 and Rule G-40 will be announced in an
MSRB Notice to be published on the MSRB's website following the
effectiveness of this proposed rule change. To provide brokers,
dealers, municipal securities dealers and municipal advisors
(collectively, ``regulated entities'') with sufficient time to develop
supervisory and compliance policies and procedures, the effective date
to be announced will be no less than 30 days and no more than 180 days
following publication of the MSRB Notice.\5\
---------------------------------------------------------------------------

    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
    \5\ See Exchange Act Release No. 83177 (May 7, 2018), 83 FR
21794 (May 10, 2018) (File No. SR-MSRB-2018-01). The amendments to
Rule G-21 and new Rule G-40 were to become effective on February 7,
2019. However, to provide the industry with sufficient time to
establish supervisory and compliance policies and procedures, the
MSRB filed with the SEC for immediate effectiveness an extension of
that effective date. The new effective date of the amendments to
Rule G-21 and new Rule G-40 will be announced in an MSRB Notice to
be published on the MSRB's website. See File No. SR-MSRB-2019-01.
---------------------------------------------------------------------------

    The text of the proposed rule change is available on the MSRB's
website at www.msrb.org/Rules-and-Interpretations/SEC-Filings/2019-Filings.aspx, at the MSRB's principal office, and at the Commission's
Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the MSRB included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The MSRB has prepared summaries, set forth in Sections
A, B, and C below, of the most significant aspects of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The purpose of the proposed rule change is to clarify for brokers,
dealers, and municipal securities dealers (collectively, ``dealers'')
and municipal advisors the application of the recent amendments to Rule
G-21 and new Rule G-40 to the use of social media by regulated entities
\6\ in connection with their municipal securities activities and
municipal advisory activities. The MSRB committed to providing that
guidance \7\ before the effective date of the amendments to the
advertising rules, and developed draft guidance regarding the use of
social media in the format of frequently asked questions (the
``FAQs'').\8\
---------------------------------------------------------------------------

    \6\ Consistent with MSRB Rule D-11, references in the FAQs to a
dealer, municipal advisor, or a regulated entity generally include
the associated persons of such dealer, municipal advisor, or
regulated entity.
    \7\ Letter from Pamela K. Ellis, Associate General Counsel,
Municipal Securities Rulemaking Board, dated April 30, 2018,
available at http://msrb.org/~/media/Files/SEC-Filings/2018/MSRB-
2018-01%20MSRB%20Letter%20to%20SEC.ashx?
    \8\ Concurrent with the submission of this proposed rule change,
the MSRB filed a proposed rule change to amend the advertising rules
to exempt interactive content that is an advertisement and that
would be posted or disseminated on an interactive electronic forum
from the requirement that a municipal securities principal, general
securities principal, or municipal advisor principal, as relevant,
approve that advertisement prior to first use.
---------------------------------------------------------------------------

    While developing the proposed rule change, the MSRB was mindful of
the potential burden on a regulated entity if there were to be
unnecessary inconsistencies between any adopted MSRB social media
guidance and similar guidance issued by other regulators that may be
applicable to other aspects of the regulated entity's business. To
inform its approach, the MSRB consulted with staff from the Financial
Industry Regulatory Authority, Inc. (``FINRA''). The MSRB endeavored,
to the extent practicable, to align the FAQs with the social media
guidance published by the SEC and FINRA.\9\
---------------------------------------------------------------------------

    \9\ See, e.g., National Examination Risk Alert, Office of
Compliance Inspections and Examinations, U.S. Securities and
Exchange Commission (Jan. 4, 2012); Exchange Act Release No. 58288
(Aug. 1, 2008); FINRA Regulatory Notice 17-18 (Apr. 2017) (``RN 17-
18''); and FINRA Regulatory Notice 10-06 (Jan. 2010) (``RN 10-06'').
---------------------------------------------------------------------------

    The FAQs are divided into four categories: Use of social media,
third-party posts, recordkeeping and supervision. Further, the FAQs
would provide references to additional resources that may be of use to
the regulated entity.
    Use of Social Media. The FAQs would provide guidance about when a
regulated entity's or its associated person's use of social media
becomes an ``advertisement'' under the advertising rules. The FAQs
would clarify that, depending on the facts and circumstances and with
limited exceptions, any material (including material that is posted on
an associated person's personal social media) that relates to (i) the
products or services of the dealer, (ii) the services of the municipal
advisor, or (iii) the engagement of a municipal advisory client by the
municipal advisor, may constitute an advertisement under the MSRB's
advertising rules, if it is published or used in any electronic or
other public media or written or electronic promotional literature
distributed or made generally available to either customers or
municipal entities, obligated persons, municipal advisory clients or
the public.
    Further, the FAQs would address:
     The other MSRB rules to consider when a regulated entity
uses social

media as part of its municipal securities or municipal advisory
activities;
     the requirement for principal pre-approval of an
advertisement; and
     a regulated entity's website hyperlinking to content on an
independent third-party's website.
    In particular, the FAQs would highlight the other obligations under
MSRB rules that regulated entities may have, in addition to those set
forth in the advertising rules, regarding the use of social media.
Those other regulatory obligations would include obligations under:
Rule G-17, on conduct of municipal securities and municipal advisory
activities; Rule G-27, on supervision; Rule G-44, on supervisory and
compliance obligations of municipal advisors; Rule G-8, on books and
records to be made by brokers, dealers, municipal securities dealers,
and municipal advisors; and MSRB Rule G-9, on retention of records.
    Further, the FAQs would reinforce that a social media post that
contains an advertisement, as defined under the advertising rules,
would be subject to approval by a principal prior to its first use.
    The FAQs would provide guidance regarding hyperlinking to an
independent third-party website from a regulated entity's website. The
FAQs would discuss the concepts of entanglement--i.e., whether the
regulated entity involved itself in the preparation of the content on
the third-party website--and adoption--i.e., whether the regulated
entity implicitly or explicitly approved or endorsed the content on
that third-party website. The FAQs then would state that the
advertising rules would apply to hyperlinked content on an independent
third-party's website if the regulated entity either were to become
entangled with or adopt that content.
    To assist regulated entities, the FAQs would identify various
factors that would be relevant in determining whether a regulated
entity has adopted or become entangled with the independent third-party
hyperlinked content. Those factors would include: The context of the
hyperlinked content; the potential for customer or municipal advisory
client confusion about the source of the content; and the nature of the
hyperlinked content (i.e., hosted by an independent third-party that is
not controlled or influenced by the regulated entity with an
``ongoing'' link). Further, the FAQs would provide that the inclusion
by a regulated entity of a disclaimer would not, alone, be sufficient
to avoid potential MSRB rule violations for hyperlinked content on an
independent third-party website if the regulated entity knows, or has
reason to know, that such content is materially false or misleading.
However, the FAQs would highlight that MSRB rules would not apply to
linked content within the independent hyperlinked content to which the
regulated entity had hyperlinked.
    Third-party posts. The FAQs would provide guidance regarding when a
post by a customer, a municipal entity client or another third-party
(collectively, a ``third-party post'') on a regulated entity's social
media page may be considered advertising under the advertising rules.
Further, the FAQs would provide that if the regulated entity were to
become entangled with or adopt such third-party posts, such third-party
posts would become subject to the advertising rules.
    In addition, the FAQs would provide guidance regarding whether a
municipal advisory client may post positive comments on a municipal
advisor's social media page about the municipal advisor's municipal
advisory activities without that post being deemed an advertisement
containing a testimonial under Rule G-40. That guidance would provide
that such post on the municipal advisor's social media page would only
be deemed to be an advertisement containing a testimonial under Rule G-
40 if the municipal advisor were to either be entangled with or adopt
the post.
    Recordkeeping. The FAQs would clarify that ``posts,'' ``chats,''
text messages, or messages sent through messaging applications related
to a regulated entity's municipal securities or municipal advisory
activities conducted through social media--regardless of (i) whether
the social media is specifically identified as business or personal,
(ii) the technology used for the messaging, or (iii) the device used
for the messaging was issued by the regulated entity-- are subject to
the MSRB's recordkeeping rules (i.e., Rules G-8 and G-9).
    Specifically, for dealers, Rule G-9(b)(viii)(C) requires that ``all
written and electronic communications received and sent, including
inter-office memoranda, relating to the conduct of the activities of
such municipal securities broker or municipal securities dealer with
respect to municipal securities'' be retained. Similarly, for municipal
advisors, Rule G-9(h)(i) requires the retention of records, which
include, among other things, originals or copies of all written and
electronic communications received and sent, including inter-office
memoranda, relating to municipal advisory activities.\10\ Neither the
technology used for the communication nor the distinction between a
communication made through a devise issued by a regulated entity or its
associated person's personal device is determinative for this
requirement.
---------------------------------------------------------------------------

    \10\ Rule G-8(f) provides in part that ``[b]rokers, dealers and
municipal securities dealers other than bank dealers which are in
compliance with rule 17a-3 of the Commission will be deemed to be in
compliance with the requirements of this rule, provided that''
certain information is maintained. Rule 17a-3(a)(20) under the
Exchange Act provides that every dealer shall keep a:
     record, which need not be separate from the advertisements,
sales literature, or communications, documenting that the member,
broker or dealer has complied with, or adopted policies and
procedures reasonably designed to establish compliance with,
applicable federal requirements and rules of a self-regulatory
organization of which the member, broker or dealer is a member which
require that advertisements, sales literature, or any other
communications with the public by a member, broker or dealer or its
associated persons be approved by a principal.
    Rule G-8(h)(i) requires municipal advisors to make and keep
current all books and records described in Rule 15Ba1-8(a) under the
Exchange Act. In particular, Rule 15Ba1-8(a)(1) requires that
municipal advisors make and keep true, accurate, and current
``originals or copies of all written communications received, and
originals or copies of all written communications sent, by such
municipal advisor (including inter-office memoranda and
communications) relating to municipal advisory activities,
regardless of the format of such communications.''
---------------------------------------------------------------------------

    Supervision. The FAQs would list MSRB rules, including the
advertising rules, Rule G-17, Rule G-8 and Rule G-9, as well as other
factors, such as usage restrictions, training and education,
recordkeeping and monitoring, that are relevant to the development of
policies and procedures regarding social media use. The FAQs also would
provide guidance under Rule G-27 and Rule G-44 about factors that may
be important for a regulated entity to consider in determining the
effectiveness of its policies and procedures regarding social media.
    Additional materials. The FAQs also would refer to resources where
additional information about the MSRB's advertising rules could be
obtained. Those resources would include the materials submitted to the
Commission in File No. SR-MSRB-2018-01 related to the recent amendments
to Rule G-21 and new Rule G-40, MSRB Notice 2018-08 concerning the
SEC's approval of those recent amendments to Rule G-21 and new Rule G-
40 and MSRB Notice 2018-32 concerning the application of the content
standards to advertisements by municipal advisors under Rule G-40.

2. Statutory Basis
    Section 15B(b)(2) of the Exchange Act \11\ provides that:
---------------------------------------------------------------------------

    \11\ 15 U.S.C. 78o-4(b)(2).

[t]he Board shall propose and adopt rules to effect the purposes of
this title with respect to transactions in municipal securities
effected by brokers, dealers, and municipal securities dealers and
advice provided to or on behalf of municipal entities or obligated
persons by brokers, dealers, municipal securities dealers, and
municipal advisors with respect to municipal financial products, the
issuance of municipal securities, and solicitations of municipal
entities or obligated persons undertaken by brokers, dealers,
---------------------------------------------------------------------------
municipal securities dealers, and municipal advisors.

    Section 15B(b)(2)(C) of the Exchange Act \12\ provides that the
MSRB's rules shall:
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78o-4(b)(2)(C).

be designed to prevent fraudulent and manipulative acts and
practices, to promote just and equitable principles of trade, to
foster cooperation and coordination with persons engaged in
regulating, clearing, settling, processing information with respect
to, and facilitating transactions in municipal securities and
municipal financial products, to remove impediments to and perfect
the mechanism of a free and open market in municipal securities and
municipal financial products, and, in general, to protect investors,
---------------------------------------------------------------------------
municipal entities, obligated persons, and the public interest.

    The MSRB believes that the proposed rule change is consistent with
Sections 15B(b)(2) \13\ and 15B(b)(2)(C) \14\ of the Exchange Act. The
proposed rule change would help to prevent fraudulent and manipulative
practices; foster coordination with persons engaged in regulating
transactions in municipal securities; and protect investors, municipal
entities, obligated persons, and the public interest.
---------------------------------------------------------------------------

    \13\ 15 U.S.C. 78o-4(b)(2).
    \14\ 15 U.S.C. 78o-4(b)(2)(C).
---------------------------------------------------------------------------

    The MSRB believes that the proposed rule change is designed to
prevent fraudulent and manipulative practices. The proposed rule change
would provide guidance to a regulated entity regarding the use of
social media under the advertising rules. By providing this guidance,
the MSRB makes clear that certain social media use by a regulated
entity would be advertising, and as such, that social media use must
comply with the standards of the advertising rules, including the
content standards. Those standards provide, among other requirements,
that advertisements be based on the principles of fair dealing and good
faith, be fair and balanced, and provide a sound basis for evaluating
the facts and that the advertisements not make any false, exaggerated,
unwarranted, promissory or misleading statement or claim.
    Because the MSRB has endeavored to make its advertising rules,
including its social media guidance, consistent with the communications
rules and social media guidance published by other financial
regulators, to the extent practicable, a regulated entity that is
dually registered as a broker, dealer or investment adviser with the
SEC may be able to more easily understand and develop consistent
practices across business lines, and therefore promote compliance with
the MSRB's advertising rules. In turn, this improved compliance would
help prevent fraudulent and manipulative practices because the proposed
rule change is designed to assist with and promote compliance with the
advertising rules, rules that in and of themselves are designed to
prevent fraudulent and manipulative practices.\15\
---------------------------------------------------------------------------

    \15\ See Exchange Act Release No. 83177 (May 7, 2018), 83 FR
21794 (May 10, 2018) (File No. SR-MSRB-2018-01).
---------------------------------------------------------------------------

    In addition, the proposed rule change would foster coordination
with persons engaged in regulating transactions in municipal
securities. As noted under ``Self-Regulatory Organization's Statement
of the Purpose of, and Statutory Basis for, the Proposed Rule Change,''
regulatory coordination has already occurred with respect to the
proposed rule change as the MSRB has consulted with FINRA staff to
inform its approach to the FAQs. Further, by providing social media
guidance that would be consistent with the social media guidance of
other financial regulators (including the social media guidance
published by the SEC and FINRA, regulators that are charged with
inspecting for compliance with MSRB rules), to the extent practicable,
those other financial regulators would be familiar with the social
media guidance, which in turn, should foster efficient examinations by
those other financial regulators of MSRB-regulated entities. In
addition, a regulated entity that is dually registered with the MSRB
and with FINRA would be treated the same under the advertising rules as
a regulated entity that is registered with the MSRB and not with FINRA.
Thus, because the MSRB has endeavored to make the proposed rule change
consistent with the communications rules and social media guidance of
FINRA, the proposed rule change would help ensure that all regulated
entities are subject to consistent advertising regulation.
    The proposed rule change also would help protect investors and the
public interest. The MSRB believes that the clear guidance provided by
the proposed rule change would help to ensure that social media use by
a regulated entity that constitutes advertising complies in a
consistent way with the advertising rules as well as relevant
supervision and recordkeeping rules.

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

    Section 15B(b)(2)(C) of the Exchange Act \16\ requires that MSRB
rules not be designed to impose any burden on competition not necessary
or appropriate in furtherance of the purposes of the Exchange Act.
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    \16\ 15 U.S.C. 78o-4(b)(2)(C).
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    The MSRB's policy on the use of economic analysis does not apply to
rulemaking proposals for which the MSRB seeks immediate
effectiveness.\17\ However, even though the MSRB did not conduct a full
economic analysis of the proposed rule change, the MSRB still conducted
an internal analysis to gauge the economic impact of the proposed rule
change, with an emphasis on the burden on competition involving
regulated entities.
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    \17\ The scope of the Board's policy on the use of economic
analysis in rulemaking provides that:
    [t]his Policy addresses rulemaking activities of the MSRB that
culminate, or are expected to culminate, in a filing of a proposed
rule change with the SEC under Section 19(b) of the Exchange Act,
other than a proposed rule change that the MSRB reasonably believes
would qualify for immediate effectiveness under Section 19(b)(3)(A)
of the Exchange Act if filed as such or as otherwise provided under
the exception process of this Policy.
    Policy on the Use of Economic Analysis in MSRB Rulemaking,
available at http://msrb.org/Rules-and-Interpretations/Economic-Analysis-Policy.aspx. For those rule changes which the MSRB seeks
immediate effectiveness, the MSRB usually focuses exclusively its
examination on the burden of competition on regulated entities.

    In this regard, the MSRB believes the proposed rule change is
necessary and appropriate in the furtherance of the purposes of the
Exchange Act because it would promote compliance by regulated entities
by promoting clarity regarding the intended application of the MSRB's
rules and would reduce confusion concerning the application of its
rules. The MSRB also believes the proposed rule change would promote
regulatory consistency with the social media guidance published by the
SEC and FINRA. In addition, the proposed rule change would apply the
social media guidance uniformly to dealers and municipal advisors, to
the extent practicable, which promotes consistency and preserves
competitive balance between regulated entities with different business
models.

Effect on Competition, Efficiency and Capital Formation
    The MSRB does not believe that the proposed rule change would
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Exchange Act, as the
proposed rule change is applicable to all dealers and municipal
advisory firms.
    Section 15B(b)(2)(L)(iv) of the Exchange Act \18\ provides that
MSRB rules may ``not impose a regulatory burden on small municipal
advisors that is not necessary or appropriate in the public interest
and for the protection of investors, municipal entities, and obligated
persons, provided that there is robust protection of investors against
fraud.'' The MSRB believes that, although the proposed rule change
would affect all municipal advisors, including small municipal
advisors, the proposed rule change is meant to clarify existing MSRB
rules and therefore would not impose additional burdens on municipal
advisors regardless of firm size.
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    \18\ 15 U.S.C. 78o-4(b)(2)(L)(iv).
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C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    The MSRB sought public comment on the FAQs in draft form.\19\ In
response to that request for comment, the MSRB received four comment
letters.\20\ Commenters generally expressed support for the guidance
contained in the FAQs, but also expressed various concerns and
suggested certain revisions. In particular, commenters focused on three
areas--interactive versus static communications, interpretations of
FINRA's social media guidance, and additional guidance.\21\ Below, the
MSRB discusses the comments received.\22\
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    \19\ MSRB Notice 2018-19 (Aug. 14, 2018) (the ``request for
comment'').
    \20\ Letter from Mike Nicholas, Chief Executive Officer, Bond
Dealers of America, dated September 14, 2018 (``BDA''); Letter from
Susan Gaffney, Executive Director, National Association of Municipal
Advisors, dated September 17, 2018 (``NAMA''); Letter from Leslie M.
Norwood, Managing Director and Associate General Counsel, Securities
Industry and Financial Markets Association, dated September 14, 2018
(``SIFMA''); and Letter from Robert J. McCarthy, Director,
Regulatory Policy, Wells Fargo Advisors, dated September 14, 2018
(``Wells Fargo'').
    \21\ NAMA also stated that ``we would like to continue to
express our general concern with having the MSRB produce guidance
that is not formally approved by the SEC.'' NAMA letter at 1.
Further, NAMA stated ``we do not believe that the information
provided in the FAQs should instead be provided through amending
current rules or developing new ones. The nature of this medium is
fluid and dynamic. The MSRB should retain sufficient flexibility to
update guidance as warranted, and doing so through rulemaking would
be premature and constricting.'' The MSRB has filed the FAQs with
the Commission in a format that is more flexible than rule text for
making future changes as appropriate in this evolving area. In
addition, the MSRB has filed a proposed rule change to amend the
advertising rules that the SEC will consider. By so doing, the MSRB
believes that it has been responsive to NAMA's concerns.
    Further, NAMA commented that the MSRB's factors that a regulated
entity ``should consider their recordkeeping obligations under
`Recordkeeping and Record Retention' in question 13 amounts to
merely issue spotting and provides no guidance.'' NAMA letter at 5.
To provide municipal advisors with the flexibility to develop
policies and procedures that reflect the municipal advisor's
organization, the MSRB developed a primarily principles-based
approach to supervision and compliance. Consistent with that
determination, the guidance in FAQ question 11 (hereinafter,
references to a given ``question'' are to a specific numbered
question in the FAQs, unless otherwise noted or the context
otherwise requires) is principles-based (question 11 was previously
question 13 in the request for comment). As the MSRB believes that
its response in question 11 is consistent with the MSRB's approach
in Rule G-44, the MSRB has determined not to revise question 11 in
response to NAMA's concerns regarding principles-based guidance.
    \22\ Commenters expressed concerns about recordkeeping as it
relates to associated persons' personal social networking pages and
to the costs of recordkeeping for small municipal advisors. The MSRB
determined that these FAQs were not the appropriate forum to address
recordkeeping requirements under the federal securities laws.
However, the MSRB may choose to address the issue, as it relates to
MSRB rules, in the future.
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Interactive Versus Static Communications
    Commenters requested that the MSRB adopt the concepts of
interactive and static content posted or disseminated to social media
sites as described in FINRA Regulatory Notice 10-06.\23\ In that
notice, FINRA provides examples of both interactive and static content,
and provides guidance that the definition of public appearance under
FINRA Rule 2210(f) includes unscripted participation in an interactive
electronic forum.\24\ Since RN 10-06, however, FINRA has amended FINRA
Rule 2210 so that such communications are now defined as retail
communications that are excepted from the requirement of principal pre-
approval.\25\ Nevertheless, such retail communications in interactive
forums are subject to other supervisory requirements and are subject to
content standards of FINRA's communications rule.\26\ However, FINRA
considers static content to constitute ``advertisements'' under FINRA
Rule 2210 and requires principal approval of such content prior to
posting.\27\
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    \23\ BDA letter; NAMA letter at 4-5; SIFMA letter at 2; and
Wells Fargo letter at 2-3.
    \24\ RN 10-06 at 4-5.
    \25\ FINRA Rule 2210(b)(1)(D) excepts from the requirement of
principal pre-approval under FINRA Rule 2210(b)(1)(A) retail
communications posted on an online interactive electronic form that
the firm supervises and reviews in the same manner as correspondence
set forth in Rule 3110(b). See FINRA Regulatory Notice 12-29 (June
2012) at 7 citing RN 10-06.
    \26\ Id.
    \27\ RN 10-06 at 5.
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    In response, the MSRB has determined to propose to amend its
advertising rules to address commenters' suggestions. Concurrent with
this proposed rule change, the MSRB has submitted a separate proposed
rule change with the Commission to do so.

Interpretations of FINRA's Social Media Guidance

    Commenters requested that the MSRB adopt their interpretations of
certain aspects of FINRA's social media guidance. Specifically,
commenters requested that the MSRB adopt interpretations regarding the
adoption of third-party content, hyperlinks, and FINRA's social media
guidance.
    Adoption. SIFMA commented that ``SIFMA and its members ``don't view
`liking' as the adoption of content'' and explained that current FINRA
guidance defines adoption ``in regard to sharing or linking'' but not
`liking'.'' \28\ Similarly, Wells Fargo suggested that the FAQs would
not align with FINRA's guidance in FINRA Regulatory Notice 17-18
regarding adoption because simply ``liking'' a post does not rise to
the level of ``sharing'' or ``linking.'' \29\
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    \28\ SIFMA letter at 3.
    \29\ Wells Fargo letter at 2.
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    FINRA has provided guidance that it would deem adoption as
explicitly or implicitly endorsing or approving third-party content,
and that by liking or sharing unsolicited favorable third-party content
posted on a representative's business-use social media website, the
representative would be adopting that content.\30\ In addition, the
MSRB submits that FINRA's guidance relating to ``shares'' and ``links''
to which commenters refer, by its own terms, does not provide the
exclusive list of how a firm can adopt independent third-party content,
but rather responds to a narrow question regarding sharing and
linking.\31\ Consistent with the SEC's

and FINRA's social media guidance, the FAQs would provide that a
regulated entity may adopt the content of a third-party post if the
regulated entity explicitly or implicitly approves or endorses the
content. Further, based on that guidance, the FAQs would provide that,
if a regulated entity ``likes'' or otherwise indicates approval with
that third-party post, then the regulated entity has adopted that
third-party post. The FAQs would provide non-exclusive factors for a
regulated entity to consider when determining whether the regulated
entity has adopted third-party content.
---------------------------------------------------------------------------

    \30\ RN 17-18 at Q9 (``[b]y liking or sharing favorable
comments, the representative has adopted them and they are subject
to the communications rules . . .'').
    \31\ RN 17-18 provides:
     Q3: If a firm shares or links to specific content posted by an
independent third-party such as an article or video, has the firm
adopted the content?
    A: By sharing or linking to specific content, the firm has
adopted the content and would be responsible for ensuring that, when
read in context with the statements in the originating post, the
content complies with the same standards as communications created
by, or on behalf of, the firm.

    The MSRB believes that the FAQs would correctly interpret the
theory of adoption as it applies to ``likes'' of third-party content
and would promote regulatory consistency with the interpretations of
other financial regulations. The MSRB has determined not to modify the
FAQs in response to SIFMA's and Wells Fargo's suggestions for
``liking'' a post as doing so would create disharmony among the
applicable regulatory interpretations.
    Relatedly, NAMA provided three suggestions regarding adoption and
entanglement. NAMA suggested that the FAQs' guidance regarding the
entanglement or adoption by a municipal advisor of third-party content
was inconsistent with the MSRB's guidance in MSRB Notice 2018-24
regarding testimonials. In particular, NAMA expressed concern that by
simply allowing third-parties to post on a municipal advisor's social
networking page, and specifically, by allowing a municipal advisory
client to post positive comments on a municipal advisor's social
networking page, the municipal advisor, itself, would be allowing an
advertisement that was a testimonial to be posted. As provided in
question 8, a municipal advisor would only be posting an advertisement
that contains a prohibited testimonial under Rule G-40 if the municipal
advisor were to become entangled with or adopt the positive comments of
the municipal advisory client. To provide clarity, the MSRB has revised
question 8 so that it now asks ``May a municipal advisory client post
positive comments about its experience with the municipal advisor on
the municipal advisor's social media page without such post being
deemed a testimonial within Rule G-40?''
    Further, NAMA suggested that the use of the term ``encourage'' when
defining entanglement was inconsistent with SEC and FINRA language
regarding entanglement.\32\ To be responsive to NAMA's concerns, the
MSRB has deleted references to ``encourage'' when discussing
entanglement.
---------------------------------------------------------------------------

    \32\ NAMA letter at 3.
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    NAMA also suggested that the MSRB explicitly define the terms
``customer complaint'' and ``municipal advisory client complaint'' when
discussing third-party posts on an associated person's social
networking page.\33\ After considering NAMA's suggestion, the FAQs
provide a reference to the definition of those terms in Rule G-8.
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    \33\ Id.
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    Hyperlinks. SIFMA and Wells Fargo recommended that the MSRB align
its guidance in question 4 relating to ongoing links with the guidance
provided by FINRA in question 5 in RN 17-18.\34\ In particular, those
commenters suggested that FINRA has provided guidance that the
determination of whether an ongoing hyperlink contains misleading
information is only made at the time the firm determines to offer a
particular hyperlink.\35\ SIFMA and Wells Fargo note that a firm would
not have the capacity to monitor the third-party website on a continual
basis.\36\
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    \34\ SIFMA letter at 3; Wells Fargo letter at 3.
    \35\ Id.
    \36\ SIFMA letter at 3; see Wells Fargo letter at 3. Wells Fargo
also suggested that it was unclear why it is necessary to review the
link's content for testimonial status. The FAQs provide that, if the
hyperlinked content on a third-party website from a regulated
entity's website is an advertisement under the advertising rules, a
regulated entity must consider all applicable provisions of the
advertising rules including whether the hyperlinked content would be
a testimonial. The need to review a hyperlink's content for
testimonial status would stem from any prior determination that the
hyperlinked content is advertising under the advertising rules.
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    Question 4 would provide guidance about ongoing links that would
promote regulatory consistency with FINRA's guidance in question 5 of
RN 17-18. In particular, the FAQs would define an ongoing link,\37\
consistent with FINRA's definition of an ongoing link,\38\ and provide
guidance that hyperlinked content may not be advertising subject to the
advertising rules if the hyperlink containing the independent third-
party content is ongoing and the regulated entity has no influence or
control over the independent third-party hosting the content. The FAQs
then would provide guidance about the factors that a regulated entity
may want to consider if the hyperlinked content is advertising subject
to the advertising rules. Similar to FINRA's guidance in RN 17-18,
question 4 in MSRB's FAQs would not specifically address requirements
to monitor an ongoing link under the MSRB's advertising rules.\39\
Because the MSRB believes that the FAQs' guidance regarding ongoing
hyperlinks would promote regulatory consistency with the relevant
guidance of other financial regulators, the MSRB has determined not to
expand the guidance regarding ongoing hyperlinks to address commenters'
suggestions.
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    \37\ Question 4 would provide, in part, as follows:
    When a regulated entity links to content that is hosted by an
independent third-party that is not controlled by the regulated
entity, that content may not be advertising subject to the MSRB's
advertising rules if the hyperlink is ``ongoing.''
    An ``ongoing'' link is one which: (i) Is continuously available
to visitors to the regulated entity's website; (ii) visitors to the
regulated entity's site have access to even though the independent
third-party site may or may not contain favorable material about the
regulated entity; and (iii) visitors to the regulated entity's
website have access to even though the independent third-party's
website may be revised. (footnote omitted) A regulated entity may
not have adopted the content on the independent third-party's
website if the link is ``ongoing.''
    \38\ RN 17-18, question 5, provides, in part, as follows:
    Whether a firm has adopted the content of an independent third-
party website or any section of the website through the use of a
link is fact dependent. Two factors are critical to the analysis:
(1) Whether the link is ``ongoing'' and (2) whether the firm has
influence or control over the content of the third-party site.
    The firm has not adopted the content if the link is ``ongoing,''
meaning:
    [rtarr9] the link is continuously available to investors who
visit the firm's site;
    [rtarr9] investors have access to the linked site whether or not
it contains favorable material about the firm; and
    [rtarr9] the linked site could be updated or changed by the
independent third- party and investors would nonetheless be able to
use the link.
    \39\ For example, a regulated entity cannot post content that it
knows or has reason to know contains any untrue statement of
material fact or is otherwise false or misleading.
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    Adoption of FINRA social media guidance. SIFMA suggested that,
because FINRA has a long history of rulemaking and guidance with
respect to social media issues, it would be helpful if dealers could
rely on FINRA's social media or other guidance.'' \40\ The MSRB
appreciates SIFMA's suggestion, and in developing the FAQs, the MSRB
was mindful of the potential burden on a regulated entity if there were
to be unnecessary inconsistencies between any adopted MSRB social media
guidance and similar guidance issued by other regulators that may be
applicable to other aspects of the regulated entity's business. To that
end, and to the extent practicable, the MSRB

endeavored to align the FAQs with the social media guidance published
by the SEC and FINRA.
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    \40\ SIFMA stated that ``it would be helpful if dealers could
rely on outstanding FINRA enforcement actions or other guidance on
social media issues.'' SIFMA letter at 3. The MSRB is not in a
position to determine when and whether statements contained in FINRA
enforcement actions, whether settled or fully litigated, involving
FINRA rules even constitute or reflect official interpretations that
are binding on FINRA members.
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    The MSRB is aware that the use of social media is an evolving
landscape, and recognizes that the MSRB will likely need to continue to
issue guidance in this area as practices and technology evolve and as
other regulators issue new rules and official guidance regarding social
media. The MSRB will continue to monitor developments in this area
(including rules and guidance of other regulators and enforcement
matters) and to seek input from regulated entities regarding the need
to issue additional guidance. In so doing, the MSRB will continue to be
mindful of the importance of regulatory certainty for regulated
entities as well as avoiding unnecessary discrepancies between the
obligations of dealers and municipal advisors, including between
municipal advisors that are also registered as dealers and municipal
advisors that are not registered as dealers (that may include municipal
advisors that are banks).
    Related to SIFMA's suggestion about adopting FINRA's social media
guidance, are NAMA's questions regarding the MSRB's use of footnotes to
reference FINRA's social media guidance and the SEC's social media
guidance in the FAQs. Specifically, NAMA questions what the footnotes
mean. The MSRB endeavors to promote regulatory consistency with other
financial regulators, when appropriate. The MSRB provided certain
references to where the MSRB is promoting regulatory consistency with
the social media guidance of other regulators. Those footnotes,
however, are not intended to suggest that regulated entities that are
not already subject to the guidance issued by the SEC and FINRA are now
obligated to act consistent with the MSRB's social media guidance as
well as with the social guidance published by the SEC or FINRA.
Additional Guidance
    The request for comment solicited suggestions where additional
guidance regarding social media use would be helpful.\41\ Commenters
provided suggestions specifically relating to the social media guidance
provided by the FAQs as discussed above, as well as to other relevant
topics. NAMA suggested that the MSRB provide additional social media
guidance specifically relating to disclaimers and hyperlinks. In
addition, NAMA suggested that the MSRB provide municipal advisors
guidance on the supervisory obligations related to the use of
electronic communications technology by a firm's associated persons
similar to FINRA's guidance in FINRA Regulatory Notice 07-59.\42\ NAMA
noted that such guidance could be particularly helpful to small
municipal advisors in assessing the compliance costs associated with
social media usage.\43\ SIFMA also provided suggestions. Specifically,
SIFMA provided a list of other issues that would benefit from further
clarification that included, among other issues, the definition of
advertising and exemptions thereof, and documentation standards.
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    \41\ Request for comment at 2.
    \42\ FINRA Regulatory Notice 07-59 (Dec. 2007).
    \43\ NAMA letter at 5-6. In addition, NAMA provided suggestions
that were beyond the scope of the social media guidance that related
to the fundamental text of Rule G-40 and the economic analysis of
the compliance costs associated with Rule G-40.
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    Any comments that may not have been specifically addressed in the
FAQs provide valuable input to inform the MSRB as it considers
developing additional guidance.

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

    Because the foregoing proposed rule change does not: (i)
Significantly affect the protection of investors or the public
interest; (ii) impose any significant burden on competition; and (iii)
become operative for 30 days from the date on which it was filed, or
such shorter time as the Commission may designate, it has become
effective pursuant to Section 19(b)(3)(A) of the Act \44\ and Rule 19b-
4(f)(6) thereunder.\45\
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    \44\ 15 U.S.C. 78s(b)(3)(A).
    \45\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of the proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-MSRB-2019-04 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-MSRB-2019-04. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's internet website (http://www.sec.gov/rules/sro.shtml).
Copies of the submission, all subsequent amendments, all written
statements with respect to the proposed rule change that are filed with
the Commission, and all written communications relating to the proposed
rule change between the Commission and any person, other than those
that may be withheld from the public in accordance with the provisions
of 5 U.S.C. 552, will be available for website viewing and printing in
the Commission's Public Reference Room, 100 F Street NE, Washington, DC
20549 on official business days between the hours of 10:00 a.m. and
3:00 p.m. Copies of the filing also will be available for inspection
and copying at the principal office of the MSRB. All comments received
will be posted without change. Persons submitting comments are
cautioned that we do not redact or edit personal identifying
information from comment submissions. You should submit only
information that you wish to make available publicly. All submissions
should refer to File Number SR-MSRB-2019-04 and should be submitted on
or before March 27, 2019.

    For the Commission, pursuant to delegated authority.\46\
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    \46\ 17 CFR 200.30-3(a)(12).
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Eduardo A. Aleman,
Deputy Secretary.
[FR Doc. 2019-03989 Filed 3-5-19; 8:45 am]
BILLING CODE 8011-01-P