Notices. Notice
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/register/2011/02/25/2011-4219A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2010-N-0597] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Index of Legally Marketed Unapproved New Animal Drugs for 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: Fax written comments on the collection of information by March 28, 2011. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or e-mailed to *oira_submission@omb.eop.gov.* All comments should be identified with the OMB control number 0910-0620. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Johnny Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7651, *Juanmanuel.vilela@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. Index of Legally Marketed Unapproved New Animal Drugs for Minor Species—21 CFR Part 516 (OMB Control Number 0910-0620)—Extension 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 in the FD&C Act (sections 571, 572, and 573 (21 U.S.C. 360ccc, 360ccc-1, and 360ccc-2)). The final rule (72 FR 69108, December 6, 2007) (the December 2007 final rule) implements section 572 of the FD&C Act that 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 December 2007 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 the new subpart C of part 516 (21 CFR 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. Section 516.141 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. In the **Federal Register** of December 3, 2010 (75 FR 75481), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received no comments. *Description of Respondents:* Pharmaceutical companies that sponsor new animal drugs. FDA estimates the burden of this collection of information as follows: Table 1—Estimated Annual Reporting Burden 1 21 CFR section No. of respondents Annual frequency per response Total annual responses Hours per response Total hours 516.119 2 1 2 1 2 516.121 30 2 60 4 240 516.123 3 1 3 8 24 516.125 2 3 6 20 120 516.129 30 2 60 20 1,200 516.141 20 1 20 16 320 516.143 20 1 20 120 2,400 516.145 20 1 20 20 400 516.161 1 1 1 4 4 516.163 1 1 1 2 2 516.165 10 2 20 8 160 Total 4,872 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 No. of recordkeepers Annual frequency per recordkeeper Total annual records Hours per recordkeeper Total hours 516.141 30 2 60 0.5 30 516.165 10 2 20 1 20 Total 50 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Dated: February 18, 2011. Leslie Kux, Acting Assistant Commissioner for Policy. [FR Doc. 2011-4219 Filed 2-24-11; 8:45 am]
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- 21 CFR 516
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