December 6, 2007

FDA Issues Final Rule on Index of Legally Marketed Unapproved New Animal Drugs for Minor Species

The Minor Use and Minor Species Animal Health Act of 2004 (MUMS act) amended the Federal Food, Drug, and Cosmetic Act (the act) to authorize the U.S. Food and Drug Administration (FDA, the agency) to establish new regulatory procedures that provide incentives intended to make more drugs legally available to veterinarians and animal owners for the treatment of minor animal species and uncommon diseases in major animal species. At this time, FDA is issuing final regulations to implement section 572 of the act entitled ``Index of Legally Marketed Unapproved New Animal Drugs for Minor Species.'' These regulations establish administrative procedures and criteria for index listing a new animal drug for use in a minor species. Such indexing provides a basis for legally marketing an unapproved new animal drug intended for use in a minor species.

DATES: This rule is effective February 19, 2008.

FDA is issuing final regulations implementing the indexing provisions of the MUMS act. These regulations establish procedures and criteria for index listing a new animal drug for use in a minor species. They describe a process whereby the agency makes a determination regarding the following: (1) The eligibility of a new animal drug, (2) the selection of a qualified expert panel, and (3) the findings of the qualified expert panel.

In the Federal Register of August 22, 2006 (71 FR 48840), FDA issued proposed regulations to implement section 572 of the act (21 U.S.C. 360ccc-1). The proposed rule initially provided for a 90-day public comment period during which the agency received several comments asserting that 90 days was not an adequate amount of time to prepare and submit meaningful comments. In response to this, in the Federal Register of October 2, 2006 (71 FR 57892), FDA extended the comment period allowing an additional 30 days of public comment.

After considering public comments FDA has made the following changes to the proposed rule:

In Sec. 516.123, paragraph (b) has been revised to read: ``The written notice will include information for scheduling the informal conference and state that a written request for a conference must be made within 60 days of the date FDA sends its notice.'' Also, paragraph (c) has been revised to read: ``Within 45 days of receiving a request for an informal conference, FDA will schedule and hold the informal conference at a time agreeable to both FDA and the person making the request.''

In Sec. 516.123, proposed paragraphs (j) and (l)(3) have been deleted and paragraph (k) has been revised to read: ``The presiding officer will prepare a written report regarding the subject of the informal conference that states and describes the basis for his or her findings. Whenever time permits, the parties to the informal conference will have 30 days to review and comment on the report.''

In section 516.141, paragraph (b)(1) has been revised to read: ``A qualified expert panel member must be an expert qualified by training and experience to evaluate a significant aspect of target animal safety or effectiveness of the new animal drug under consideration.''

In addition, FDA has made two technical corrections to the proposed rule. The first one is in part 25 (21 CFR part 25). An amendment to Sec. 25.33 was proposed as a conforming change to add index listed drugs to the list of actions for animal drugs which may be categorically excluded from the preparation of an environmental assessment. However, the agency neglected to propose a corresponding amendment to Sec. 25.20 to also add index listed drugs to the list of actions requiring preparation of an environmental assessment. Therefore, this final rule contains a conforming change to Sec. 25.20(m) to correct this omission. The second technical correction is in part 207 (21 CFR part 207).

Amendments to Sec. Sec. 207.21 and 207.35 were proposed as conforming changes to include index listed drugs under the drug registration and listing provisions of part 207. However, the agency neglected to propose a corresponding amendment to Sec. 207.20(c) which describes who must register and submit a drug list. Therefore, this final rule contains a conforming change to Sec. 207.20(c) to correct this omission.

The Federal Register notice can be accessed at http://frwebgate4.access.gpo.gov/cgi-bin/waisgate.cgi?WAISdocID=95399127465+10+0+0&WAISaction=retrieve