Reporting Associated with New Animal Drug Applications

ICR 201605-0910-014

OMB: 0910-0032

Federal Form Document

Forms and Documents
Form and Instruction
Form and Instruction
Supporting Statement A
ICR Details
0910-0032 201605-0910-014
Historical Active 201305-0910-003
Reporting Associated with New Animal Drug Applications
Extension without change of a currently approved collection   No
Approved without change 08/11/2016
Retrieve Notice of Action (NOA) 06/03/2016
  Inventory as of this Action Requested Previously Approved
08/31/2019 36 Months From Approved 08/31/2016
1,008 0 1,367
21,959 0 28,218
0 0 0

Under section 512(b)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360b(b)(1)), any person may file a new animal drug application (NADA) seeking our approval to legally market a new animal drug. Section 512(b)(1) sets forth the information required to be submitted in a NADA. Sections 514.1, 514.4, 514.6, 514.8, and 514.11 of our regulations (21 CFR 514.1, 514.4, 514.6, 514.8, and 514.11) further specify the information that the NADA must contain. 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. FDA Guidance #152 outlines a risk assessment approach for evaluating the microbial food safety of antimicrobial new animal drugs. We request that applicants utilize Form FDA 356V, as appropriate, to ensure efficient and accurate processing of information to support new animal drug approval.

US Code: 21 USC 512 Name of Law: FD&C Act

Not associated with rulemaking

  81 FR 10871 03/02/2016
81 FR 35744 06/03/2016

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 1,008 1,367 0 0 -359 0
Annual Time Burden (Hours) 21,959 28,218 0 0 -6,259 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Although the number of respondents has increased (an adjustment from 169 to 182 due to natural increases in the animal drug industry) the overall burden has reduced from 28,218 to 21,959 because we have determined that the number of responses per respondent has decreased. The previously approved ICR submitted to OMB in 2013 included nine ICs entered into ROCIS. Upon this submission we are consolidating the ICs, thereby, reducing the number of ICs in ROCIS to one. The information collection activities, however, remain broken down in this supporting statement document.

Ila Mizrachi 301 796-7726 [email protected]


On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.

© 2024 | Privacy Policy