Labeling Requirements for Human Prescription Drug and Biological Products

Forms and Documents

Document Name	Status
0572 Rx Labeling Requirements SSA 2025 REV.docx Supporting Statement A	2025-01-30
0572_Change Request.docx Justification for No Material/Nonsubstantive Change	2022-02-10

IC Document Collections

IC ID	Document Title	Status
6295	Drug labeling requirements; prescription drugs	Modified
251545	Safety Labeling Changes; Posting Approved Labeling on Application Holder's website Instruction	Modified
251544	Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statemen Instruction	Modified
251542	Exemption Request from Bar Code Label Requirements	Unchanged
251540	Supporting cardiovascular claims Instruction	Modified
251539	Strategic National Stockpile (SNS) Labels	Modified
250908	Labeling requirements; medical gas containers	Unchanged

ICR Details

OMB Control No: 0910-0572	ICR Reference No: 202408-0910-009
Status: Received in OIRA	Previous ICR Reference No: 202202-0910-001
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Labeling Requirements for Human Prescription Drug and Biological Products
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 01/31/2025

	Requested	Previously Approved
Expiration Date	36 Months From Approved	01/31/2025
Responses	433,324	433,323
Time Burden (Hours)	1,913,896	1,913,864
Cost Burden (Dollars)	0	129,150

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Abstract: The information collection supports agency regulations governing the content and format of labeling for human prescription drug and biological products. Respondents to the collection are sponsors of new drug and biological product applications.

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Authorizing Statute(s): None

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 76853	09/19/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	90 FR 8753	01/31/2025
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 7

IC Title	Form No.	Form Name
Drug labeling requirements; prescription drugs
Exemption Request from Bar Code Label Requirements
Labeling requirements; medical gas containers
Safety Labeling Changes (Section 505(o)(4) of the FD&C Act)-- Rebuttal Statemen
Safety Labeling Changes; Posting Approved Labeling on Application Holder's website
Strategic National Stockpile (SNS) Labels
Supporting cardiovascular claims

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ICR Summary of Burden

	Total Request	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	433,324	433,323	0	0	1	0
Annual Time Burden (Hours)	1,913,896	1,913,864	0	0	32	0
Annual Cost Burden (Dollars)	0	129,150	0	0	-129,150	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement: The information collection reflects nominal adjustments that include the addition of one response and 32 hours annually, and we have removed costs previously attributable to respondents publicly posting safety labeling changes which we believe is now usual and customary practice. At the same time, we have clarified the scope of activity announcing in our notice OMB approved-modifications since last review (changes approving the addition of recommendations found in guidance; burden associated with Strategic National Stockpile labeling; bar code exemptions; and hypertension claims) and invited public comment. Although no comments were received as discussed in Q-8, we characterized the renewal request as a revision.

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Annual Cost to Federal Government: $41,785,141

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.     No

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: 01/31/2025

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