Labeling Requirements for Approved or Conditionally Approved New Animal Drugs - Proposed rule.

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
CVMNADLabelingPRIA-03-01-2024.docx	Supplementary Document	Uploaded 2024-03-07	Repair queued
RIN AI43 NADLabeling SSA 06-07-2023.docx	Supporting Statement A	Uploaded 2024-03-07	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
265841	One-time Recordkeeping for NEW requirements		New
265840	One-time Reporting resulting from NEW requirements		New

ICR Details

OMB Control No: 0910-0927	ICR Reference No: 202403-0910-003
Status: Historical Inactive	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No: CVM
Title: Labeling Requirements for Approved or Conditionally Approved New Animal Drugs - Proposed rule.
Type of Information Collection: New collection (Request for a new OMB Control Number)	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule	Conclusion Date: 04/10/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 03/07/2024
Terms of Clearance: In accordance with 5 CFR 1320, the information collection is not approved at this time. Prior to publication of the final rule, the agency should provide to OMB a summary of all comments received on the proposed information collection and identify any changes made in response to these comments.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date		36 Months From Approved
Responses	0	0	0
Time Burden (Hours)	0	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request supports FDA rulemaking. FDA is proposing revisions to regulations to update current requirements and remove those that have become obsolete. The proposed requirements would apply to the labeling of prescription and over-the-counter (OTC) new animal drugs, as well as new animal drugs for use in animal feeds.

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Authorizing Statute(s): US Code: 21 USC 352 Name of Law: FFDCA; Misbranded drugs and devices
   US Code: 21 USC 360b Name of Law: New Animal Drugs
  

Citations for New Statutory Requirements: US Code: 21 USC 301 et seq. Name of Law: FFDCA
US Code: 21 USC 360b Name of Law: New Animal Drugs
US Code: 21 USC 331 Name of Law: Prohibited Acts

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AI43	Proposed rulemaking	89 FR 11223	03/07/2024

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
One-time Recordkeeping for NEW requirements
One-time Reporting resulting from NEW requirements

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: Rulemaking included on regulatory agenda. If finalized, we expect the rulemaking to result in an additional x hours and y responses to the agency’s active collection inventory. We further expect that the additional burden will be incorporated into OMB control no. 0910-0032, New Animal Drug Applications.

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Annual Cost to Federal Government: $11,554,740

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 03/07/2024

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