2017-15206. 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 August 21, 2017.

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: [phone], or emailed to [e-mail]. 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:

Ila S. Mizrachi, Office of Operations, Food and Drug Administration, Three White Flint North, 10A63, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-7726.

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 (the MUMS Act) (Pub. L. 108-282) added section 572 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360ccc-1), which authorizes 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). In enacting the MUMS Act, Congress sought to encourage the development of these new animal drugs. Congress recognized that the markets for drugs intended to treat these species, diseases, or conditions are so small that there are often insufficient economic incentives to motivate drug companies to develop data to support approvals. Further, Congress recognized that some minor species populations are too small or their management systems too diverse to make it practical to conduct traditional studies to demonstrate safety and effectiveness of animal drugs for such uses. As a result of these limitations, drug companies have generally not been willing or able to collect data to support legal marketing of drugs for these species, diseases, or conditions. Consequently, Congress enacted the MUMS Act to provide incentives to develop new animal drugs for minor species, while still ensuring appropriate safeguards for animal and human health. Section 572 of the FD&C Act provides for a public index listing of legally marketed unapproved new animal drugs for minor species. FDA regulations in part 516 (21 CFR part 516) specify, 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. The administrative procedures and criteria for indexing a new animal drug for use in a minor species are set forth in 21 CFR 516.111 through 516.171. Section 516.165 sets forth the annual reporting requirements for index holders. FDA needs the information to determine: (1) The eligibility of a new animal drug for indexing; (2) that a qualified expert panel proposed to review certain information regarding the new animal drug meets the selection criteria listed in the regulations; (3) whether the Agency agrees with the recommendation of a qualified expert panel that a drug be added to the index; and (4) whether there may be grounds for removing a drug from the index.

In the Federal Register of December 21, 2016 (81 FR 93689), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment, which was outside the scope of the comment requests in the notice.

FDA estimates the burden of this collection of information as follows:

Table 1—Estimated Annual Reporting Burden ¹

21 CFR section	Number of respondents	Number of responses per respondent	Total annual responses	Average burden per response	Total hours
516.119—requires a foreign drug company to submit and update the name and address of a permanent U.S. resident agent	2	1	2	1	2
516.121—written request for a meeting with FDA to discuss the requirements for indexing a new animal drug	30	2	60	4	240
516.123—written request for an informal conference and a requestor's written response to an FDA initial decision denying a request	3	1	3	8	24
516.125—correspondence and information associated with investigational use of new animal drugs intended for indexing	2	3	6	20	120
516.129—content and format of a request for determination of eligibility for indexing	30	2	60	20	1,200
516.141—information to be submitted to FDA by a requestor seeking to establish a qualified expert panel	20	1	20	16	320
516.143—content and format of the written report of the qualified expert panel	20	1	20	120	2,400
516.145—content and format of a request for addition to the Index	20	1	20	20	400
516.161—content and format of a request for modification of an indexed drug	1	1	1	4	4
516.163—information to be contained in a request to FDA to transfer ownership of a drug's index file to another person	1	1	1	2	2
516.165—requires drug experience reports and distributor statements to be submitted to FDA	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	Number of recordkeepers	Number of records per recordkeeper	Total annual records	Average burden per recordkeeping	Total hours
516.141—requires the qualified expert panel leader to maintain a copy of the written report and all notes or minutes relating to panel deliberations that are submitted to the requestor for 2 years after the report is submitted	30	2	60	*.5	30
516.165—requires the holder of an indexed drug to maintain records of all information pertinent to the safety or effectiveness of the indexed drug, from foreign and domestic sources	10	2	20	1	20
Total					50
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
*30 minutes.

We based our estimates in tables 1 and 2 on our experience with the MUMS indexing program and the requests for eligibility for indexing and for addition to the index, as well as the periodic drug experience reports submitted during the past 3 years. The burden has not changed since the last OMB approval.

Dated: July 13, 2017.

Anna K. Abram,

Deputy Commissioner for Policy, Planning, Legislation, and Analysis.