When used in relation to the Horseracing Integrity and Safety Act, 15 U.S.C. 3051 through 3060, and this subpart—

Act means the Horseracing Integrity and Safety Act, 15 U.S.C. 3051 through 3060.

Breeder means a person who is in the business of breeding covered horses.

Commission means the Federal Trade Commission.

Covered horse means any Thoroughbred horse, or any other horse made subject to the Act by election of the applicable State racing commission or the breed governing organization for such horse under 15 U.S.C. 3054(l), during the period—

(1) Beginning on the date of the horse's first timed and reported workout at a racetrack that participates in covered horseraces or at a training facility; and

(2) Ending on the date on which the Authority receives written notice that the horse has been retired.

Covered horserace means any horserace involving covered horses that has a substantial relation to interstate commerce, including any Thoroughbred horserace that is the subject of interstate off-track or advance deposit wagers.

Covered persons means all trainers, owners, breeders, jockeys, racetracks, veterinarians, persons (legal and natural) licensed by a State racing commission and the agents, assigns, and employees of such persons and other horse support personnel who are engaged in the care, training, or racing of covered horses.

HISA Guidance means Horseracing Integrity and Safety Authority (Authority) guidance issued under 15 U.S.C. 3054(g)(1), which does not have the force of law.

Horseracing anti-doping and medication control program means the anti-doping and medication program established under 15 U.S.C. 3055(a).

Horseracing Integrity and Safety Authority or Authority means the private, independent, self-regulatory, nonprofit corporation recognized for purposes of developing and implementing a horseracing anti-doping and medication control program and a racetrack safety program for covered horses, covered persons, and covered horseraces.

Interstate off-track wager has the meaning given such term in Section 3 of the Interstate Horseracing Act of 1978, 15 U.S.C. 3002.

Jockey means a rider or driver of a covered horse in covered horseraces.

Owner means a person who holds an ownership interest in one or more covered horses.

Proposed rule means any rule proposed by the Authority pursuant to the Act.

Proposed rule modification or modification means:

(1) Any proposed modification to a rule or proposed rule change; or

(2) Any interpretation or statement of policy or practice relating to an existing rule of the Authority that is not HISA Guidance and would have the force of law if approved as a final rule.

Racetrack means an organization licensed by a State racing commission to conduct covered horseraces.

Racetrack safety program means the program established under 15 U.S.C. 3056(a).

State racing commission means an entity designated by State law or regulation that has jurisdiction over the conduct of horseracing within the applicable State.

Trainer means an individual engaged in the training of covered horses.

Training facility means a location that is not a racetrack licensed by a State racing commission that operates primarily to house covered horses and conduct official timed workouts.

Veterinarian means a licensed veterinarian who provides veterinary services to covered horses.

Workout means a timed running of a horse over a predetermined distance not associated with a race or its first qualifying race, if such race is made subject to the Act by election under 15 U.S.C. 3054(l) of the horse's breed governing organization or the applicable State racing commission.

The Authority must submit to the Commission any proposed rule, or proposed rule modification, of the Authority relating to—

(a) The bylaws of the Authority;

(b) A list of permitted and prohibited medications, substances, and methods, including allowable limits of permitted medications, substances, and methods;

(c) Laboratory standards for accreditation and protocols;

(d) Standards for racing surface quality maintenance;

(e) Racetrack safety standards and protocols;

(f) A program for injury and fatality data analysis;

(g) A program of research and education on safety, performance, and anti-doping and medication control;

(h) A description of safety, performance, and anti-doping and medication control rule violations applicable to covered horses and covered persons;

(i) A schedule of civil sanctions for violations;

(j) A process or procedures for disciplinary hearings;

(k) A formula or methodology for determining assessments described in 15 U.S.C. 3052(f); and

(l) Any other proposed rule or modification the Act requires the Authority to submit to the Commission for approval.

(a) Contents of submission. In order for a submission to qualify as a proposed rule or proposed rule modification under 15 U.S.C. 3053(a), the Authority must submit to the Commission a complete draft of the Federal Register document for the proposed rule or proposed rule modification, which includes the text of the rule and a statement of the purpose of, and statutory basis for, the proposed rule or modification (“statement of basis and purpose”). The statement of basis and purpose must contain:

(1) The reasons for adopting the proposed rule or modification.

(2) Any problems the proposed rule or modification is intended to address and how the proposed rule or modification will resolve those problems.

(3) A description of any reasonable alternatives to the proposed rule or modification that may accomplish the stated objective and an explanation of the reasons the Authority chose the proposed rule or modification over its alternatives.

(4) How the proposed rule or modification will affect covered persons, covered horses, and covered horseraces.

(5) Why the proposed rule or modification is consistent with the requirements of the Act and any rules and regulations applicable to the Authority, including the following:

(i) Anti-doping and medication control program. When proposing a rule or modification to the horseracing anti-doping and medication control program, the Authority must explain how it considered the factors in 15 U.S.C. 3055,including.S.C. 3055(a)(2), the unique characteristics of a breed of horse made subject to the Act by election of a State racing commission or breed governing organization for such horse pursuant to 15 U.S.C. 3054(l);

(B) The factors listed in 15 U.S.C. 3055(b); and

(C) The baseline anti-doping and medication control rules identified in 15 U.S.C. 3055(g)(2)(A). For a proposed rule, the Authority must state whether its proposed rule adopts the baseline standards identified in 15 U.S.C. 3055(g)(2)(A). If there is a conflict in any baseline standards identified in 15 U.S.C. 3055(g)(2)(A), the Authority must identify the conflict and state whether the standard it adopted is the most stringent standard. For a proposed rule modification, the Authority must explain whether the modification renders an anti-doping and medication control rule less stringent than the baseline anti-doping and medication control rules described in 15 U.S.C. 3055(g)(2)(A), and state whether the anti-doping and medication control enforcement agency has approved of the change.

(ii) Racetrack safety program. When proposing a rule or modification to any rule regarding the racetrack safety program required under 15 U.S.C. 3056(a)(1), the Authority must explain how the proposed rule or modification meets the requirements in 15 U.S.C. 3056(b). The Authority must explain how it considered and whether it adopted the safety standards in 15 U.S.C. 3056(a)(2). If any horseracing safety standards in 15 U.S.C. 3056(a)(2) were considered but not adopted or were modified, the Authority must explain why it decided not to adopt or why it decided to modify such standard.

(iii) Other rules. To the extent the Act requires the Authority to consider any factors or standards not specifically referenced in this section, the Authority must explain whether and how it considered those factors when proposing a rule or modification. For instance, when proposing a civil sanctions rule or modification pursuant to 15 U.S.C. 3057(d)(1), the Authority must explain how the rule or modification meets the requirements of 15 U.S.C. 3057(d)(2).

(6) If written comments were solicited, the Authority's draft Federal Register document must include a summary of the substance of all comments received and the Authority's written response to all significant issues raised in such comments.

(7) The date that the Authority proposes for the Federal Register to publish its proposed rule or modification.

(b) Supporting documentation. The Authority's submission to the Commission required under paragraph (a) of this section must also include copies of the pertinent factual information underlying the Authority's development of the proposed rule or modification, including a copy of existing standards used as a reference for the development of the proposed rule or modification and scientific data, studies, or analysis underlying the development of the proposed rule or modification. Supporting documentation must be attached as exhibits, and each exhibit must clearly identify the proposed rule or modification it supports.

(c) Redline document for proposed rule modification. For proposed rule modifications, the Authority must also provide, in a document separate from the Federal Register document, a redline version of the existing rule that will enable the Commission to immediately identify any proposed changes.

(d) Timing of submission. To qualify as a proposed rule or proposed modification under 15 U.S.C. 3053(a), the Authority's submission must provide the information in paragraphs (a), (b), and (c) of this section at least 90 days in advance of the proposed date for the Federal Register to publish a proposed rule or modification for public comment pursuant to 15 U.S.C. 3053(b)(1). The Secretary may waive the 90-day requirement in this section if the Authority demonstrates such waiver is necessary to meet statutory deadlines.

(e) Conclusory statements and failure to provide requisite analysis. Information required to be submitted under this section must be sufficiently detailed and contain sufficient analysis to support a Commission finding that a proposed rule or modification satisfies the statutory requirements. For instance, a mere assertion or conclusory statement that a proposed rule or modification is consistent with the requirements of the Act is insufficient. Failure to describe and justify the proposed rule or modification in the manner described in this section or failure to submit the information required by this section may result in the Commission's having insufficient information to make an affirmative finding that the proposed rule or modification is consistent with the Act and the applicable rules approved by the Commission.

(f) Public comments. The Authority is encouraged to solicit public comments on its proposed rule or modification in advance of making a submission to the Commission pursuant to this section. If the Authority solicits public comments, it must attach a copy of the comments as an exhibit to its submission. By soliciting public comments and addressing significant issues raised therein, the Authority facilitates the Commission's review and approval of the Authority's proposed rule or modification.

(a) Electronic submission. All submissions from the Authority to the Commission pursuant to the provisions of subpart S or U of this part, and all submissions to the Commission pursuant to 15 U.S.C. 3053(a) (proposed rules or rule modifications), 15 U.S.C. 3052(f)(1)(C)(iv) (proposed rate increases), or 15 U.S.C. 3054(g)(2) (guidance) must be emailed to the Secretary of the Commission at [email protected]. The subject line of the email must begin with “HISA Submission:” followed by a brief description of the submission.

(b) Format for submissions—(1) Electronic format. All documents submitted to the Secretary under this section must be submitted in .pdf format or in some other electronic format specified by the Office of the Secretary. The proposed text of Federal Register publications must also be submitted in a Microsoft Word or .rtf format.

(2) Table of contents. Submissions with more than one attachment must contain a table of contents in the body of the email with a brief description of each item.

(3) Contact information. The Authority must provide the name, telephone number, and email address of a person on the staff of the Authority responsible for responding to questions and comments on the submission in the body of the email.

(4) Draft Federal Register documents. Draft Federal Register documents must follow the relevant format and editorial requirements for regulatory documents under 1 CFR parts 18, 21, and 22 (see Office of Federal Register's Document Drafting Handbook). The Document Drafting Handbook specifies that draft Federal Register documents (see 1 CFR 15.10) must:

(i) Contain proper preamble captions and content;

(ii) State the purpose of, and basis for, the proposed rule or modification;

(iii) Set forth regulatory text, headings, and authority citations;

(iv) Use correct numbering, structure, and amendatory language; and

(v) Conform to the style and formatting established by the Office of the Federal Register and Government Publishing Office. (See, specifically, section 2.17 (proposed rules) of the Office of the Federal Register's Document Drafting Handbook.)

(c) Confidential information. If a document filed with the Secretary contains confidential information, the Secretary must be so informed, and a request for confidential treatment must be submitted in accordance with 16 CFR 4.9.

(d) Date of filing. If the conditions of this section are otherwise satisfied, all filings submitted electronically on or before 5:30 p.m. Eastern Time, on a business day, will be deemed filed on that business day, and all filings submitted after 5:30 p.m. Eastern Time, will be deemed filed on the next business day.

(e) Authority to reject documents for filing. The Secretary of the Commission may reject a document for filing that fails to comply with the Commission's rules.

(f) Federal Register publication. For submissions required to be published in the Federal Register, if the conditions set forth in this section and § 1.142 have been satisfied, the Commission will publish the Authority's submission in the Federal Register.

(a) Commission decision. The Commission will approve or disapprove a proposed rule or modification by issuing an order within 60 days of the date the proposed rule or modification was published in the Federal Register for public comment.

(b) Standard of review. The Commission will approve a proposed rule or modification if the Commission finds that the proposed rule or modification is consistent with the Act and the applicable rules approved by the Commission. If the Commission disapproves a rule or modification, it will make recommendations to the Authority to modify the proposed rule or modification within 30 days of such disapproval.

(c) Effect. A proposed rule or modification will not take effect unless it has been approved by the Commission.