Reporting Associated with New Animal Drug Applications and Veterinary Master Files

ICR 201905-0910-005

OMB: 0910-0032

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Supporting Statement A
2019-05-20
IC Document Collections
ICR Details
0910-0032 201905-0910-005
Active 201605-0910-014
HHS/FDA CVM
Reporting Associated with New Animal Drug Applications and Veterinary Master Files
Extension without change of a currently approved collection   No
Regular
Approved without change 07/26/2019
Retrieve Notice of Action (NOA) 06/26/2019
  Inventory as of this Action Requested Previously Approved
07/31/2022 36 Months From Approved 08/31/2019
1,008 0 1,008
22,083 0 21,959
0 0 0

Any person may file a new animal drug application (NADA) seeking FDA approval to legally market a new animal drug. 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 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. Respondents may choose to use veterinary master files to provide and organize confidential detailed information to the Agency. Veterinary master files can be used as repositories for information that can be referenced in multiple submissions to the Agency, thus minimizing paperwork burden.

US Code: 21 USC 512 Name of Law: FD&C Act
  
None

Not associated with rulemaking

  84 FR 4479 02/15/2019
84 FR 29866 06/25/2019
No

  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 1,008 0 0 0 0
Annual Time Burden (Hours) 22,083 21,959 0 0 124 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
Based on a review of the information collection since our last request for OMB approval, we have made the following adjustments: In previous submissions of this ICR we included the time necessary to compile and submit information to veterinary master files within the burden estimates provided for applications and amended applications (for NADAs and INAD files). In this request for OMB extension of approval, we anticipate respondents’ need for increased use of veterinary master files and therefore seek approval for such increase. We have separately estimated the burden of the “Use of veterinary master files during all phases of product development (including product development that precedes the establishment of an INAD file or the submission of an NADA)” in table 1, row 10. We report an additional 300 burden hours and 15 total annual responses in row 10, representing such increased use of veterinary master files. In addition, we are also correcting several rounding errors that were made in our last request for OMB approval. Thus, our estimated burden for the information collection reflects a net overall increase of 124 hours and a corresponding increase of 14 responses.

$10,315,360
No
    Yes
    No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 [email protected]

  No

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.
06/26/2019


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