This PDF is the current document as it appeared on Public Inspection on 05/10/2013 at 08:45 am.
Food and Drug Administration, HHS.
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.
Fax written comments on the collection of information by June 12, 2013.
To ensure that comments on the information collection are received, OMB recommends that written Start Printed Page 27970comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-7285, or emailed to email@example.com. 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.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Jonna Capezzuto, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B, Rockville, MD 20850, 301-796, 3794, Jonnalynn.firstname.lastname@example.org.End Further Info End Preamble Start Supplemental 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 Guidance #152, and Form FDA 356V—21 CFR 514.5, 514.1, 514.4, and 514.8 (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) of the FD&C Act 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 of Title 21 of the Code of Federal Regulations 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 a NADA seeking approval to legally market a new animal drug. Section 512(b)(1) sets forth the information required to be submitted in a NADA. FDA allows applicants to submit a complete NADA or to submit information in support of a NADA for phased review followed by submission of an administrative NADA when FDA finds all the applicable technical sections are complete.
Section 514.1 of Title 21 of the Code of Federal Regulations interprets section 512(b)(1) of the FD&C Act and further describes the information that must be submitted as part of a 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 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 Form FDA 356V to ensure efficient and accurate processing of information to support new animal drug approval.
In the Federal Register of November 20, 2012, (77 FR 69630), 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:
|21 CFR Section/FDA form No.||Number of respondents||Number of responses per respondent||Total annual responses||Average burden per response||Total hours|
|514.5(b), (d), (f) Requesting presubmission conferences||169||0.41||69||50||3,450|
|514.1 and 514.6 Applications and amended applications||169||0.07||12||212||2,544|
|514.8(b) Manufacturing changes to an approved application||169||2.22||375||35||13,125|
|514.8(c)(1) Labeling and other changes to an approved application||169||0.06||10||71||710|
|514.8(c)(2) and (3) Labeling and other changes to an approved application||169||0.72||121||20||2,420|
|514.11 Submission of data, studies and other information||169||0.08||14||1||14|
|558.5(i) Requirements for liquid medicated feed||169||0.01||1.7||5||8.5|
|514.1(b)(8) and 514.8(c)(1) 2 Evidence to establish safety and effectiveness||169||0.15||25||90||2,250|
|Form FDA 356V||169||4.37||739||5||3,695|
|1 There are no capital costs or operating and maintenance costs associated with this collection of information.|
|2 NADAs and supplements regarding antimicrobial animal drugs that use a recommended approach to assessing antimicrobial concerns as part of the overall preapproval safety evaluation.|
Based on the number of sponsors subject to animal drug user fees, FDA estimates that there was an average of 169 annual respondents during the 5 fiscal years, from October 1, 2008, through September 30, 2012, on which Start Printed Page 27971these estimates were made. We use this estimate consistently throughout the table and calculate the “total annual responses” by multiplying the number of responses per respondent by the number of respondents.Start Signature
Dated: May 7, 2013.
Assistant Commissioner for Policy.
[FR Doc. 2013-11273 Filed 5-10-13; 8:45 am]
BILLING CODE 4160-01-P