Section 522.1077 - Gonadorelin(a)Specifications. Each milliliter (mL) of solution contains:(1) 43 micrograms ([MICRO]g) of gonadorelin as gonadorelin acetate;(2) 100 [MICRO]g of gonadorelin as gonadorelin acetate;(3) 50 [MICRO]g of gonadorelin as gonadorelin diacetate tetrahydrate (equivalent to 43 [MICRO]g gonadorelin); or(4) 50 [MICRO]g of gonadorelin as gonadorelin hydrochloride.(b)Sponsors. See sponsor numbers in § 510.600(c) of this chapter. (1) No. 000061 for use of the 43-[MICRO]g/mL product described in paragraph (a)(1) as in paragraphs (e)(1)(i) and (iii) of this section.(2) No. 068504 for use of the 100-[MICRO]g/mL product described in paragraph (a)(2) as in paragraphs (d)(1)(i) and (iv) of this section.(3) Nos. 000010 and 061133 for use of the 50-[MICRO]g/mL product described in paragraph (a)(3) of this section as in paragraphs (e)(1)(i) and (v) of this section.(4) No. 054771 for use of the 50-[MICRO]g/mL product described in paragraph (a)(4) as in paragraphs (e)(1)(ii) and (vi) of this section.(c)Related tolerances. See § 556.304 of this chapter.(d)Special considerations.(1) Concurrent luteolytic drug use is approved as follows: (i) Cloprostenol injection for use as in paragraph (e)(1)(iii) of this section as provided by No. 000061 in § 510.600(c) of this chapter.(ii) Cloprostenol injection for use as in paragraph (e)(1)(iv) of this section as provided by No. 068504 in § 510.600(c) of this chapter.(iii) Cloprostenol injection for use as in paragraph (e)(1)(v) of this section as provided by Nos. 000010 in § 510.600(c) of this chapter.(iv) Dinoprost injection for use as in paragraph (e)(1)(vi) of this section as provided by No. 054771 in § 510.600(c) of this chapter.(2) Federal law restricts this drug to use by or on the order of a licensed veterinarian.(e)Conditions of use in cattle - (1)Indications for use and amounts.(i) For the treatment of ovarian follicular cysts in dairy cattle: Administer 86 [MICRO]g gonadorelin (No. 000061), or 100 [MICRO]g gonadorelin diacetate tetrahydrate (Nos. 000010 and 061133), or 100 [MICRO]g gonadorelin (as gonadorelin acetate; No. 068504) by intramuscular or intravenous injection.(ii) For the treatment of ovarian follicular cysts in cattle: Administer 100 [MICRO]g gonadorelin hydrochloride by intramuscular injection.(iii) For use with cloprostenol sodium to synchronize estrous cycles to allow for fixed-time artificial insemination (FTAI) in beef cows and lactating dairy cows: Administer to each cow 86 [MICRO]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 [MICRO]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 86 [MICRO]g gonadorelin by intramuscular injection.(iv) 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 [MICRO]g gonadorelin by intramuscular injection, followed 6 to 8 days later by 500 [MICRO]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 [MICRO]g gonadorelin by intramuscular injection.(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 [MICRO]g gonadorelin diacetate tetrahydrate by intramuscular injection, followed 6 to 8 days later by 500 [MICRO]g cloprostenol by intramuscular injection, followed 30 to 72 hours later by 100 [MICRO]g gonadorelin diacetate tetrahydrate by intramuscular injection.(vi) 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 [MICRO]g 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 [MICRO]g gonadorelin by intramuscular injection.83 FR 64740, Dec. 18, 2018, as amended at 84 FR 8973, Mar. 13, 2019; 84 FR 39184, Aug. 9, 2019; 84 FR 32992, July 11, 2019; 86 FR 13184, Mar. 8, 2021; 86 FR 14820, Mar. 19, 2021; 87 FR 17946, Mar. 29, 2022; 88 FR 27699, May 3, 2023 As amended at 81 FR 36789, 6/8/2016; as amended at 81 FR 36789, 6/8/2016; 83 FR 64740, 12/18/2018; as amended at 84 FR 8973, 3/13/2019; 84 FR 39184, 8/9/2019; 84 FR 32992, 9/9/2019; 86 FR 13184, 3/8/2021; 86 FR 14820, 3/19/2021; 87 FR 17946, 3/29/2022; 88 FR 27699, 5/3/2023