Rules and Regulations. Notice of availability

Agency: Food and Drug Administration, HHS
Action: Notice of availability
Citation: FR Doc. 2020-15203 · Docket No. FDA-1997-D-0444

Summary

The Food and Drug Administration (FDA or Agency) is announcing the availability of draft guidance for industry (GFI) #61 entitled “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species.” This draft guidance is intended to assist those interested in pursuing FDA approval of new animal drugs intended for minor uses in major species or for use in minor species (MUMS drugs). It outlines the basic statutory and regulatory requirements and special considerations for these approvals, and describes the incentives available to encourage the development of MUMS drugs.

Dates

Submit either electronic or written comments on the draft guidance by November 12, 2020 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.

Supplementary Information

I. Background FDA is announcing the availability of draft GFI #61 entitled “Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species.” This draft guidance replaces final GFI #61, issued in April 1999 (with a minor update in May 2008) entitled “FDA Approval of New Animal Drugs for Minor Uses and for Minor Species.” This draft guidance, when finalized, should assist those interested in pursuing FDA approval of MUMS drugs. It outlines the basic statutory and regulatory requirements and special considerations for these approvals, and describes the incentives available to encourage the development of MUMS drugs. This level 1 draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on approval MUMS drugs. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 FDA tentatively concludes that this draft guidance contains no collection of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required. However, this draft guidance refers to previously approved FDA collections of information. These collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 511 have been approved under OMB control number 0910-0117; in 21 CFR part 514 have been approved under OMB control numbers 0910-0032 and 0910-0284; and in 21 CFR part 516 have been approved under OMB control numbers 0910-0605 and 0910-0620. III. Electronic Access Persons with access to the internet may obtain the guidance at either https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or https://www.regulations.gov. Dated: July 7, 2020. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2020-15203 Filed 7-14-20; 8:45 am]