E8-14653. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Animal Drugs for Investigational Use

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 28, 2008.

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 e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-0117. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.

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.

New Animal Drugs for Investigational Use (OMB Control Number 0910-0117)—Extension

FDA has authority under the Federal Food, Drug, and Cosmetic Act (the act) to approve new animal drugs. Section 512(j) of the act (21 U.S.C.360b(j)), authorized FDA to issue regulations for the investigational use of new animal drugs. The regulations which set forth conditions for investigational use of new animal drugs are codified under part 511 (21 CFR part 511). If a new animal drug is only for tests in vitro, or testing in laboratory research animals, the person distributing the new animal drug must maintain records showing: (1) The name and post office address of the expert or expert organization to whom the drug is shipped; and (2) the date, quantity, batch or code mark for each shipment for a period of 2 years after such shipment or delivery. Prior to shipping a new animal drug for clinical investigations in animals, a sponsor must submit to FDA a Notice of Claimed Investigational Exemption (NCIE). The NCIE must contain, among other things, the following specific information: (1) The identity of the new animal drug, (2) labeling, (3) a statement of compliance of any non-clinical laboratory studies with good laboratory practices, (4) the name and address of each clinical investigator, (5) the approximate number of animals to be treated or amount of new animal drug(s) to be shipped, and (6) information regarding the use of edible tissues from investigational animals. Part 511 also requires that records be established and maintained to document the distribution and use of the investigational drug to assure that its use is safe and that the distribution is controlled to prevent potential abuse. The agency uses these required records under its Bio-Research Monitoring Program to monitor the validity of the studies submitted to FDA to support new animal drug approval and to assure that proper use of the drug is maintained by the investigator.

Investigational new animal drugs are used primarily by the pharmaceutical industry, academic institutions, and the government. Investigators may include individuals from these entities as well as research firms and members of the medical professional. Respondents to this collection of information are investigators who use new animal drugs for investigational purposes.

In the Federal Register of April 8, 2008 (73 FR 19073), FDA published a 60-day notice requesting public comment on the information collection provisions. No comments were received.

Table 1.—Estimated Annual Reporting Burden¹

21 CFR Section	No. of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours
511.1(b)(4)	134	7.66	1027	8	8,216
511.1(b)(5)	134	.19	25	140	3,500
511.1(b)(6)	134	.01	2	1	2
511.1(b)(8) (ii)	134	.11	15	20	300
511.1(b)(9)	134	6.7	20	8	160
Total					12,178
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Table 2.—Estimated Annual Recordkeeping Burden¹

21 CFR Section	No. of Recordkeepers	Annual Frequency per Recordkeeping	Total Annual Records	Hours per Recordkeeper	Total Hours
511.1(a)(3)	134	2.96	400	9	3,600
511.1(b)(3)	134	7.66	1,027	1	1,027
511.1(b)(7)(ii)	134	7.46	1,000	3.5	3,500
511.1(b)(8)(i)	134	7.46	1,000	3.5	3,500
Total					11,627
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

The burden estimates for reporting requirements, record preparation, and maintenance for this collection of information are based on agency communication with industry. Based on the number of sponsors subject to animal drug user fees, FDA estimates that there are 134 respondents. We use this estimate consistently throughout the table and calculated the “annual frequency per respondent” by dividing the total annual responses by number of respondents. Additional information needed to make final calculations of the total burden hours i.e., the number of respondents, the number of record keepers, the number of NCIEs received, etc., was derived from agency records.

Dated: June 23, 2008.

Jeffrey Shuren,

Associate Commissioner for Policy and Planning.