Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2026-N-1305] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Minor Use and Minor Species AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Submit written comments (including recommendations) on the collection of information by July 29, 2026. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting “Currently under Review—Open for Public Comments” or by using the search function. The OMB control number for this information collection is 0910-0605. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Kelly Covington, Center for Veterinary Medicine, Food and Drug Administration, 5001 Campus Drive, College Park, MD 20740, 240-402-5661, PRAStaff@fda.hhs.gov. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. New Animal Drugs for Minor Use and Minor Species—21 CFR Part 516 OMB Control Number 0910-0605—Extension This information collection supports implementation of sections 572 and 573 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.SC. 360ccc-1 and 21 U.S.C. 360ccc-2) which establish requirements for the Designation of a Minor Use or Minor Species New Animal Drug and Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, respectively. Agency regulations are codified in 21 CFR part 516 and include recordkeeping and reporting requirements. The general provisions in 21 CFR 516 subpart A set forth its purpose, scope, and applicable definitions (21 CFR part 516 subpart A). Regulations in 21 CFR part 516 subpart B provide for designation status for Minor Use and Minor Species (MUMS) drugs prior to their approval or conditional approval. MUMS-drug designation makes the sponsor eligible for incentives to support the approval or conditional approval of the designated use and is completely optional for drug sponsors. The regulations describe how to apply for designation, what needs to be submitted and other information pertaining to this option. Sponsors of designated new animal drugs are required to demonstrate “due diligence” toward approval or conditional approval through submission of annual reports documenting their progress for each designated use. The FDA uses this information to allow for determining eligibility for designation and the associated incentives and benefits described in section 573 of the act, including a 7-year period of exclusive marketing rights. It enables FDA to process requests for MUMS-drug designation, requests to amend MUMS-drug designation, changes in sponsorship, termination of MUMS-drug designation, requirements for annual reports from sponsors, and provisions for insufficient quantities of MUMS-designated drugs. Sponsors use FDA's “eSubmitter” system to fill out a series of system generated screens to submit their request and annual report electronically. To access the “eSubmitter” system, sponsors will use a previously established account. Regulations in 21 CFR 516 subpart C are intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species (21 U.S.C. 360ccc). The purpose of these regulations is to encourage the development of these new animal drugs, while still ensuring appropriate safeguards for animal and human health. In some cases, a minor species drug is intended for use in species that are too rare or too varied to be the subject of adequate and well-controlled studies in support of a drug approval. In such cases, FDA may add the drug to the Index of Legally Marketed Unapproved New Animal Drugs for Minor Species as provided for by Section 572 of the FD&C Act (21 U.S.C. 360ccc-2). Within limitations established by the statute, such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species. FDA regulations in 21 CFR part 516 Subpart C specify, among other things, the criteria and procedures for requesting eligibility for indexing and for requesting addition to the Index, as well as the annual reporting requirements for index holders. The administrative procedures and criteria for indexing a new animal drug for use in a minor species, as well as modifications and removal of a drug from the index are also set forth. FDA uses the information for the activities described above. Requestors can either mail paper submissions to the FDA or use FDA's “eSubmitter” system to fill out a series of system generated screens to submit their request electronically. To access the “eSubmitter” system, sponsors will use a previously established account. Description of Respondents: The respondents to this information collection are pharmaceutical companies that sponsor new animal drugs for designation or requesters wishing to add a new animal drug to the Index. In the Federal Register of February 20, 2026 (91 FR 8253), FDA published a 60-day notice requesting public comment on the proposed collection of information. One comment was received. While the commenter supported the collection of information requirements, they raised concerns about the administrative and financial burden on smaller companies, recommending that FDA develop templates or guidance materials to ease the process for these companies. FDA appreciates the comment. FDA provides a Small Business Guide on the Agency's website at http://www.fda.gov/ForIndustry/SmallBusinessAssistance/default.htm. FDA has also published the following Guidance for Industry (GFI) documents to assist companies developing drugs for minor uses and minor species. Online or written comments on any guidance can be submitted at any time (see 21 CFR 10.115(g)(5)). • CVM GFI #61—Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species • CVM GFI #170—Animal Drug User Fees and Fee Waivers and Reductions • CVM GFI #200—SECG for Designation of New Animal Drugs for Minor Uses/Minor Species • CVM GFI #201—SECG for Index of Legally Marketed Unapproved New Animal Drugs for Minor Species In addition, we are currently revising CVM GFI#210—The Index of Legally Marketed Unapproved New Animal Drugs for Minor Species to help companies navigate the indexing process. FDA estimates the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden  1 21 CFR section; activity Number of respondents Number of responses per respondent Total annual responses Average burden per response Total hours Designated New Animal Drugs for Minor Use and Minor Species, Subpart B 516.20; content and format of MUMS-drug designation request 5 2 10 16 160 516.26; requirements for amending MUMS-drug designation 3 1 3 2 6 516.27; change in sponsorship of MUMS-drug designation 1 1 1 1 1 516.29; termination of MUMS-drug designation 2 1 2 1 2 516.30; requirements of annual reports from sponsor(s) of MUMS-designated drugs 26 2 52 2 104 516.36; consequences for insufficient quantities of MUMS-designated drugs 1 1 1 3 3 Subtotal 276 Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Subpart C 516.119; requires a foreign drug company to submit and update the name and address of a permanent U.S. resident agent 10 1 10 1 10 516.121; written request for a meeting with FDA to discuss the requirements for indexing a new animal drug 15 2 30 4 120 516.123; written request for an informal conference and a requestor's written response to an FDA initial decision denying a request 3 1 3 8 24 516.125; correspondence and information associated with investigational use of new animal drugs intended for indexing 2 3 6 20 120 516.129; content and format of a request for determination of eligibility for indexing 20 2 40 20 800 516.141; information to be submitted to FDA by a requestor seeking to establish a qualified expert panel 20 1 20 16 320 516.143; content and format of the written report of the qualified expert panel 20 1 20 120 2,400 516.145; content and format of a request for addition to the Index 10 1 10 20 200 516.161; content and format of a request for modification of an indexed drug 10 1 10 4 40 516.163; information to be contained in a request to FDA to transfer ownership of a drug's index file to another person 1 1 1 2 2 516.165; requires drug experience reports and distributor statements to be submitted to FDA 25 10 250 5 1250 Subtotal 5,286 Total 5,562 1  There are no capital costs or operating and maintenance costs associated with this collection of information. Table 2—Estimated Annual Recordkeeping Burden  1 21 CFR section, activity No. of recordkeepers No. of records per recordkeeper Total annual records Average burden per recordkeeping Total Index of Legally Marketed Unapproved New Animal Drugs for Minor Species, Subpart C 516.141, requires the qualified expert panel leader to maintain a copy of the written report and all notes or minutes relating to panel deliberations that are submitted to the requestor for 2 years after the report is submitted 30 2 60 0.5 (30 min.) 30 516.165, requires the holder of an indexed drug to maintain records of all information pertinent to the safety or effectiveness of the indexed drug, from foreign and domestic sources 25 2 50 1 50 Total 80 1  There are no capital costs or operating and maintenance costs associated with this collection of information. Our estimated reporting and recordkeeping burden for the information collection reflects an overall increase of 60 hours and a corresponding increase of 120 responses and records. We attribute this adjustment to an increase in the number of submissions we received over the last few years. Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs. [FR Doc. 2026-13005 Filed 6-26-26; 8:45 am] BILLING CODE 4164-01-P