2020-15991. Veterinary Feed Directive Drugs; Contact Information

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Final rule; technical amendment.

SUMMARY:

The Food and Drug Administration (FDA) is amending the animal drug regulations to revise a current mailing address and to add an email address to the previously codified contact information for use by distributors of an animal feed containing a veterinary feed directive (VFD) drug or a combination VFD drug. This technical amendment is being made to improve the accuracy and completeness of the regulations.

DATES:

This rule is effective August 18, 2020.

FOR FURTHER INFORMATION CONTACT:

Isabel Pocurull, Center for Veterinary Medicine (HFV-221), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 240-402-5877, [e-mail].

SUPPLEMENTARY INFORMATION:

FDA is amending the animal drug regulations to revise a current mailing address and to add an email address to the previously codified contact information for use by distributors of an animal feed containing a VFD drug or a combination VFD drug.

This final rule sets forth a technical amendment to the regulations to improve the accuracy and completeness of the regulations, and as such does not impose any burden on regulated entities. Although denominated a rule pursuant to the Federal Food, Drug, and Cosmetic Act, this document does not meet the definition of “rule” in 5 U.S.C. 804(3)(A) because it is a “rule of particular applicability.” Therefore, it is not subject to the congressional review requirements in 5 U.S.C. 801-808. Likewise, this is not a rule subject to Executive Order 12866, which defines a rule as “an agency statement of general applicability and future effect, which the agency intends to have the force and effect of law, that is designed to implement, interpret, or prescribe law or policy or to describe the procedure or practice requirements of an agency.”

List of Subjects in 21 CFR Part 558

• Animal drugs
• Animal feeds

Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 558 is amended as follows:

PART 558—NEW ANIMAL DRUGS FOR USE IN ANIMAL FEEDS

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

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

2. In § 558.6, revise paragraph (c)(7) to read as follows:

§ 558.6

Veterinary feed directive drugs.

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(c) * * *

(7) The notifications cited in paragraphs (c)(5) and (6) of this section must be submitted to the Food and Drug Administration, Center for Veterinary Medicine, Division of Animal Feeds (HFV-220), 12225 Wilkins Ave., Rockville, MD 20852, Fax: [phone], or email (via attachment): [e-mail].

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Dated: July 17, 2020.

Lauren K. Roth,

Associate Commissioner for Policy.