Source: https://www.federalregister.gov/documents/2014/04/07/2014-07708/agency-information-collection-activities-proposed-collection-comment-request-index-of-legally
Timestamp: 2018-07-16 11:03:01
Document Index: 731607036

Matched Legal Cases: ['art 516', 'art 516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516', '§\u2009516']

Federal Register :: Agency Information Collection Activities; Proposed Collection; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for Minor Species; Extension
79 FR 19094
2014-07708
Index of Legally Marketed Unapproved New Animal Drugs for Minor Species 21 CFR Part 516 (OMB Control Number 0910-0620)—Extension
https://www.federalregister.gov/d/2014-07708 https://www.federalregister.gov/d/2014-07708
Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget Start Printed Page 19095(OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.
Description: The Minor Use and Minor Species Animal Health Act of 2004 (MUMS Act) amended the Federal Food, Drug, and Cosmetic Act (the FD&C Act) to authorize FDA to establish new regulatory procedures intended to make more medications legally available to veterinarians and animal owners for the treatment of minor animal species (species other than cattle, horses, swine, chickens, turkeys, dogs, and cats), as well as uncommon diseases in major animal species.
The MUMS Act created three new sections to the FD&C Act (sections 571, 572, and 573), and this final rule implements section 572, which provides for an index of legally marketed unapproved new animal drugs for minor species. Participation in any part of the MUMS program is optional so the associated paperwork only applies to those who choose to participate. The final rule specifies, 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.
Under subpart C of part 516, § 516.119 provides requirements for naming a permanent resident U.S. agent by foreign drug companies, and § 516.121 provides for informational meetings with FDA. Section 516.123 provides requirements for requesting informal conferences regarding Agency administrative actions and § 516.125 provides for investigational use of new animal drugs intended for indexing. Provisions for requesting a determination of eligibility for indexing can be found under § 516.129 and provisions for subsequent requests for addition to the index can be found under § 516.145. A description of the written report required in § 516.145 can be found under § 516.143. Under § 516.141 are provisions for drug companies to nominate a qualified expert panel as well as the panel's recordkeeping requirements. This section also calls for the submission of a written conflict of interest statement to FDA by each proposed panel member. Index holders are able to modify their index listing under § 516.161 or change drug ownership under § 516.163. Requirements for records and reports are under § 516.165.
Description of Respondents: Pharmaceutical companies that sponsor new animal drugs. FDA estimates the burden for this collection of information as follows:
516.129 30 2 60 20 1200
516.143 20 1 20 120 2400
516.141 30 2 60 2 0.5 30
[FR Doc. 2014-07708 Filed 4-4-14; 8:45 am]