Link to an amendment published at 84 FR 32992, July 11, 2019.

1. (a) Specifications. Each milliliter (mL) of solution contains:

   1. (1) 43 micrograms (µg) of gonadorelin as gonadorelin acetate;
   2. (2) 100 µg of gonadorelin as gonadorelin acetate;
   3. (3) 43 µg of gonadorelin as gonadorelin diacetate tetrahydrate; or
   4. (4) 50 µg of gonadorelin as gonadorelin hydrochloride.

2. (b) Sponsors. See sponsor numbers in § 510.600(c) of this chapter.

   1. (1) No. 000061 for use of the 43-µg/mL product described in paragraph (a)(1) as in paragraphs (d)(1)(i), (d)(1)(iv), and (d)(2) of this section.
   2. (2) No. 068504 for use of the 100-µg/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(ii), (d)(1)(v), and (d)(2) of this section.
   3. (3) No. 061133 for use of the 43-µg/mL product described in paragraph (a)(3) as in paragraphs (d)(1)(i) and (d)(2) of this section.
   4. (4) No. 000010 for use of the 43-µg/mL product described in paragraph (a)(3) as in paragraphs (d)(1)(i), (d)(1)(vi), and (d)(2) of this section.
   5. (5) No. 054771 for use of the 50-µg/mL product described in paragraph (a)(4) as in paragraphs (d)(1)(iii), (d)(1)(vii), and (d)(2) of this section.

3. (c) Special considerations. Concurrent luteolytic drug use is approved as follows:

   1. (1) Cloprostenol injection for use as in paragraph (d)(1)(iv) of this section as provided by No. 000061 in § 510.600(c) of this chapter.
   2. (2) Cloprostenol injection for use as in paragraph (d)(1)(v) and (d)(1)(vi) of this section as provided by No. 000061 or No. 068504 in § 510.600(c) of this chapter.
   3. (3) Dinoprost injection for use as in paragraph (d)(1)(vii) of this section as provided by No. 054771 in § 510.600(c) of this chapter.

4. (d) Conditions of use in cattle - (1) Indications for use and amounts.

   1. (i) For the treatment of ovarian follicular cysts in dairy cattle: Administer 86 µg gonadorelin (No. 000061) or 100 µg gonadorelin diacetate tetrahydrate (Nos. 061623 and 050604) by intramuscular or intravenous injection.
   2. (ii) For the treatment of ovarian follicular cysts in dairy cattle: Administer 100 µg gonadorelin by intramuscular or intravenous injection.
   3. (iii) For the treatment of ovarian follicular cysts in cattle: Administer 100 µg gonadorelin by intramuscular injection.
   4. (iv) For use with cloprostenol injection to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 86 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 µg gonadorelin by intramuscular injection.
   5. (v) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 µg gonadorelin by intramuscular injection.
   6. (vi) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in lactating dairy cows and beef cows: Administer to each cow 100 µg gonadorelin diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days later by 500 µg cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 µg gonadorelin diacetate tetrahydrate by intramuscular injection.
   7. (vii) For use with dinoprost injection to synchronize estrous cycles to allow fixed-time artificial insemination (FTAI) in lactating dairy cows: Administer to each cow 100 to 200 µg gonadorelin by intramuscular injection, followed 6 to 8 days later by 25 mg dinoprost by intramuscular injection, followed 30 to 72 hours later by 100 to 200 µg gonadorelin by intramuscular injection.
   8. (2) Limitations. Federal law restricts this drug to use by or on the order of a licensed veterinarian.

[83 FR 64740, Dec. 18, 2018, as amended at 84 FR 8973, Mar. 13, 2019; 84 FR 39184, Aug. 9, 2019]