Description
On December 6, 2007 (72 FR 69108), FDA published a final rule in the Federal Register, entitled “Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.” This final rule implements section 572 of the Federal Food, Drug, and Cosmetic Act (FFDCA), which provides for a public index listing of legally marketed unapproved new animal drugs for minor species of animals (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats). 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.
Scope & Applicability
Product Classes
3The category of products covered by this guidance.
Species other than major species like cattle, horses, swine, etc.
manufactured using Type A medicated article
Stakeholders
4Qualified individuals who review target animal safety and effectiveness.
Any person or group of persons marketing, manufacturing, processing, or developing a drug; Entity maintaining information for demonstrations of safety and effectiveness
Group that reviews the safety and effectiveness for indexing
Representative of a foreign owner who serves as the FSVP importer; Person in the US acting as a communications link or FSVP representative.; Designated representative for foreign owners; designated representative for foreign owners
Regulatory Context
Attributes
1Data requested by CVM to demonstrate the safety of the cat food
Identified Hazards
Hazards
1Must be disclosed and certified against by expert panel members.
Related CFR Sections (8)
- 21CFR516.129§ 516.129 Content and format of a request for determination of eligibility for indexing.
(a) Each request for determination of eligibility:Read full regulation →
- 21CFR516.141§ 516.141 Qualified expert panels.
(a) Establishment of a qualified expert panel. Establishing a qualified expert panel is the first step in the process of requesting the addition of a new animal drug to the index. A qualified expert panel may not be established until FDA has determined that the new animal drug is eligible for indexiRead full regulation →
- 21CFR516.143§ 516.143 Written report.
The written report required in § 516.145(b)(3) shall:Read full regulation →
- 21CFR516.145§ 516.145 Content and format of a request for addition to the index.
(a) A requestor may request addition of a new animal drug to the index only after the new animal drug has been granted eligibility for indexing.Read full regulation →
- 21CFR516.149§ 516.149 Denying a request for addition to the index.
(a) FDA will deny a request for addition to the index if it finds the following:Read full regulation →
- 21CFR516.157§ 516.157 Publication of the index and content of an index listing.
(a) FDA will make the list of indexed drugs available through the FDA Web site at http://www.fda.gov . A printed copy can be obtained by writing to the Freedom of Information Staff or by visiting FDA's Freedom of Information Staff's Public Reading Room at the address listed on the Agency's Web site Read full regulation →
- 21CFR516.165§ 516.165 Records and reports.
(a) Scope and purpose.Read full regulation →
- 21CFR516.161§ 516.161 Modifications to indexed drugs.
(a) After a drug is listed in the index, certain modifications to the index listing may be requested. Any modification of an index listing may not cause an indexed drug to be a different drug (or different combination of drugs) or a different dosage form. If such modification is requested, FDA will Read full regulation →
See Also (8)
- CVM GFI #200 SECG for Designation of New Animal Drugs for Minor Uses or Minor Species (Status: Final)
- CVM GFI #61 Special Considerations, Incentives, and Programs to Support the Approval of New Animal Drugs for Minor Uses and for Minor Species (Status: Final)
- On the Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for an Allergenic Extract or Allergen Patch Test: Guidance for Industry (Status: Final)
- Guidance for Industry: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to CFSAN (Status: Final)
- Guidance for Industry: Questions and Answers About the Food Additive or Color Additive Petition Process (Status: Final)
- Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use (Status: Final)
- Environmental Assessment of Human Drug and Biologics Applications: Guidance for Industry (Status: Final)
- Content and Format of Chemistry, Manufacturing and Controls Information and Establishment Description Information for a Vaccine or Related Product: Guidance for Industry (Status: Final)