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| HHS/FDA | RIN: 0910-AG07 | Publication ID: Spring 2008 |
| Title: ¤Conditional Approval of New Animal Drugs for Minor Use and Minor Species | |
| Abstract: This proposed rule implements section 571 of the Minor Use and Minor Species Animal Health Act of 2004 (MUMS act). The MUMS act added three sections to the Federal Food, Drug, and Cosmetic Act (the Act) (571, 572, and 573), and it established new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species, as well as uncommon diseases in major animal species. Section 571 of the act provides for animal drug conditional approval after all safety and manufacturing components of a new animal drug approval have met the standards of section 512 of the act. For the effectiveness component of a new animal drug approval, a reasonable expectation of effectiveness must be established prior to conditional approval under section 571 of the act. Sponsors then have up to 5 years to complete the demonstration of effectiveness by the standards of section 512 of the act and achieve a complete new animal drug approval. | |
| Agency: Department of Health and Human Services(HHS) | Priority: Routine and Frequent |
| RIN Status: First time published in the Unified Agenda | Agenda Stage of Rulemaking: Proposed Rule Stage |
| Major: No | Unfunded Mandates: No |
| CFR Citation: 21 CFR 516 (To search for a specific CFR, visit the Code of Federal Regulations.) | |
| Legal Authority: 21 USC 360cc | |
Legal Deadline:
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Timetable:
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| Regulatory Flexibility Analysis Required: No | Government Levels Affected: None |
| Small Entities Affected: Businesses | Federalism: No |
| Included in the Regulatory Plan: No | |
| RIN Data Printed in the FR: No | |
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Agency Contact: Gail Schmerfeld Supervisory Regulatory Counsel Department of Health and Human Services Food and Drug Administration HFV-100, Center for Veterinary Medicine, 7500 Standish Place, MPN-2, Rm. 384, HFV-100, Rockville, MD 20855 Phone:240 276-8304 Email: gail.schmerfeld@fda.hhs.gov |
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