79 FR 119 pgs. 35357-35358 - 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
Type: NOTICEVolume: 79Number: 119Pages: 35357 - 35358
Pages: 35357, 35358Docket number: [Docket No. FDA-2010-N-0597]
FR document: [FR Doc. 2014-14473 Filed 6-19-14; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
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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 July 21, 2014.
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 emailed 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:
FDA PRA Staff, Office of Operations, Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver Spring, MD 20993-0002, PRAStaff@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)
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 of the FD&C Act (21 U.S.C. 360ccc-1), 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.
In the Federal Register of April 7, 2014 (79 FR 19094), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.
[top] FDA estimates the burden of this collection of information as follows:
| 21 CFR Section | Number of respondents | Number of responses per respondent | Total annual responses | Average burden 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 | 1200 |
| 516.141 | 20 | 1 | 20 | 16 | 320 |
| 516.143 | 20 | 1 | 20 | 120 | 2400 |
| 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 is no capital or operating and maintenance cost associated with this collection of information. | |||||
| 21 CFR Section | Number of recordkeepers | Number of records per recordkeeper | Total annual records | Average burden per recordkeeping | Total hours |
|---|---|---|---|---|---|
| 516.141 | 30 | 2 | 60 | 2 0.5 | 30 |
| 516.165 | 10 | 2 | 20 | 1 | 20 |
| Total | 50 | ||||
| 1 There is no capital or operating and maintenance cost associated with this collection of information. | |||||
| 2 30 minutes. | |||||
Dated: June 16, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-14473 Filed 6-19-14; 8:45 am]
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