Format and Content Requirements for Over-the-Counter Drug Product Labeling

Forms and Documents

Document Name	Status
Form FDA 5009 OTC User Fee Program Form	Unchanged
CHANGE REQUEST 0340 Change Request to include 0641 GFI. 12.17.21.docx Justification for No Material/Nonsubstantive Change	2021-12-17
0340 OTC User Fee Change Dec 2020.docx Justification for No Material/Nonsubstantive Change	2020-12-01
0340 OTC Drug Labeling SSA 2019 Ext.pdf Supporting Statement A	2019-12-05

IC Document Collections

IC ID	Document Title	Status
5943	Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products (including sunscreen products)	Unchanged
250630	Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose Other-Guidance	New
244708	OTC User Fee Program Form	Unchanged
209796	Format and Content Requirements; exemptions and deferrals	Unchanged

ICR Details

OMB Control No: 0910-0340	ICR Reference No: 202112-0910-002
Status: Received in OIRA	Previous ICR Reference No: 202011-0910-003
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Format and Content Requirements for Over-the-Counter Drug Product Labeling
Type of Information Collection: No material or nonsubstantive change to a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular	Date Submitted to OIRA: 12/17/2021

	Requested	Previously Approved
Expiration Date	12/31/2022	12/31/2022
Responses	8,760	7,860
Time Burden (Hours)	98,495	94,895
Cost Burden (Dollars)	1,950,000	1,950,000

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Abstract: The information collection supports agency regulations at 21 CFR 201.66. Respondents to the collection of information are producers or manufacturers of drug products requiring over-the-counter (OTC) labeling subject to these regulatory and statutory requirements. This information collection also supports implementation of the Dietary Supplement and Nonprescription Drug Consumer Protection Act (DSNDCPA) (Pub. L. 109-462). The Public Law added section 502(x) to the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 352(x)), requiring the label of a nonprescription drug product marketed without an approved application in the United States to include a domestic address or domestic telephone number through which a manufacturer, packer, and distributor may receive a report of a serious adverse event associated with its product(s).

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic Act
   PL: Pub.L. 109 - 462 760 Name of Law: Dietary Supplement and Nonprescription Drug Consumer Protection Act
  

Citations for New Statutory Requirements: PL: Pub.L. 116 - 136 3851 Name of Law: CARES

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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:
	84 FR 28555	06/21/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 61064	11/12/2019
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Domestic Address or Phone Number Labeling Requirement (21 U.S.C. 352(x)) and Recommendation to Clarify its Purpose
Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products (including sunscreen products)
Format and Content Requirements; exemptions and deferrals
OTC User Fee Program	FDA 5009	OVER-THE-COUNTER MONOGRAPH USER FEE COVER SHEET

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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	8,760	7,860	0	0	900	0
Annual Time Burden (Hours)	98,495	94,895	0	0	3,600	0
Annual Cost Burden (Dollars)	1,950,000	1,950,000	0	0	0	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: For efficiency of agency operations, we are requesting to consolidate two related information collections, OMB Control Nos. 0910-0641 and 0910-0340. Accordingly, we have adjusted the estimated burden in control number 0910-0340 by 900 responses and 3,600 hours annually to reflect this change. Upon approval of this request, we intend to discontinue the collection of information currently approved under OMB control number 0910-0641.

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Annual Cost to Federal Government: $0

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? Yes

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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: 12/17/2021

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