2011-8906. Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Presubmission Conferences, New Animal Drug Applications and Supporting Regulations, and Food and Drug Administration Form ...

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 May 13, 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: [phone], or e-mailed to [e-mail]. All comments should be identified with the OMB control number 0910-0032. Also include the FDA docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Juanmanuel Vilela, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796-7651, [e-mail].

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.

Presubmission Conferences, New Animal Drug Applications and Supporting Regulations, and FDA Form 356V—(OMB Control Number 0910-0032)—Extension

Under section 512(b)(3) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(b)(3)), any person intending to file a new animal drug application (NADA) or supplemental NADA or a request for an investigational exemption under section 512(j) is entitled to one or more conferences with FDA to reach an agreement acceptable to FDA establishing a submission or investigational requirement. FDA and industry have found that these meetings have increased the efficiency of the drug development and drug review processes.

Section 514.5 (21 CFR 514.5) describes the procedures for requesting, conducting, and documenting presubmission conferences. Section 514.5(b) describes the information that must be included in a letter submitted by a potential applicant requesting a presubmission conference, including a proposed agenda and a list of expected participants. Section 514.5(d) describes the information that must be provided by the potential applicant to FDA at least 30 days prior to a presubmission conference. This information includes a detailed agenda, a copy of any materials to be presented at the conference, a list of proposed indications and, if available, a copy of the proposed labeling for the product under consideration, and a copy of any background material that provides scientific rationale to support the potential applicant's position on issues listed in the agenda for the conference. Section 514.5(f) discusses the content of the memorandum of conference that will be prepared by FDA and gives the potential applicant an opportunity to seek correction to or clarification of the memorandum.

Under section 512(b)(1) of the FD&C Act, any person may file an NADA seeking approval to legally market a new animal drug. Section 512(b)(1) of the FD&C Act sets forth the information required to be submitted in an NADA. FDA allows applicants to submit a complete NADA or to submit information in support of an NADA for phased review followed by submission of an Administrative NADA when FDA finds all the applicable technical sections are complete.

The regulations under 21 CFR 514.1 interpret section 512(b)(1) of the FD&C Act and further describe the information that must be submitted as part of an NADA and the manner and form in which the NADA must be assembled and submitted. The application must include safety and effectiveness data, proposed labeling, product manufacturing information, and where necessary, complete information on food safety (including microbial food safety) and any methods used to determine residues of drug chemicals in edible tissue from food-producing animals. Guidance #152 entitled “Evaluating the Safety of Antimicrobial New Animal Drugs With Regard to Their Microbiological Effects on Bacteria of Human Health Concern” outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs. FDA requests that an applicant accompany NADAs, supplemental NADAs, and requests for phased review of data to support NADAs, with the FDA Form 356V to ensure efficient and accurate processing of information to support new animal drug approval.

In the Federal Register of February 8, 2011 (76 FR 6798), FDA published a 60-day notice requesting public comment on the proposed collection of information. No comments were received.

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

Table 1—Estimated Annual Reporting Burden ¹

21 CFR Section/FDA Form No.	Number of respondents 4	Number of responses per respondent	Total annual responses	Average burden per response (in Hours)	Total hours
514.5(b), (d) and (f)	154	.6	92.4	50	4,620
514.1 and 514.6	154	.1	15.4	212	3,265
514.4 2	154	0	0	0	0
514.8(b)	154	2.84	437.36	35	15,308
514.8(c)(1)	154	.1	15.4	71	1,093
514.8(c)(2) and (c)(3)	154	.7	107.8	20	2,156
514.11	154	.2	30.8	1	31
558.5(i)	154	.01	1.54	5	8
514.1(b)(8) and 514.8(c)(1) 3	154	.21	32.34	90	2,911
FDA Form 356V	154	5.1	785.4	5	3,927
Total					33,319
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 Substantial Evidence—Because 21 CFR 514.4 only defines substantial evidence, it should not be viewed as creating additional collection burden.
3 NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as part of the overall preapproval safety evaluation.
4 Based on the number of sponsors subject to animal drug user fees, FDA estimates that there was an average of 154 annual respondents during the 5 fiscal years, from October 1, 2005, through September 30, 2010, on which these estimates were made. We use this estimate consistently throughout the table and calculate the “annual frequency per respondent” by dividing the total annual responses by the number of respondents.

Dated: April 7, 2011.

Leslie Kux,

Acting Assistant Commissioner for Policy.