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

Forms and Documents

Document	Type	Status	Availability
Form FDA 5009 OTC User Fee Program	Form	New	Available
0340 OTC User Fee Change Dec 2020.docx	Justification for No Material/Nonsubstantive Change	Uploaded 2020-12-01	Available
0340 OTC Drug Labeling SSA 2019 Ext.pdf	Supporting Statement A	Uploaded 2019-12-05	Available

IC Document Collections

IC ID	Collection	Type	Status	Form
5943	Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products (including sunscreen products)		Unchanged
244708	OTC User Fee Program	Form	New
209796	Format and Content Requirements; exemptions and deferrals		Unchanged

ICR Details

OMB Control No: 0910-0340	ICR Reference No: 202011-0910-003
Status: Active	Previous ICR Reference No: 201911-0910-009
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
OIRA Conclusion Action: Approved without change	Conclusion Date: 12/08/2020
	Date Received in OIRA: 12/01/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2022	12/31/2022	12/31/2022
Responses	7,860	0	7,859
Time Burden (Hours)	94,895	0	94,320
Cost Burden (Dollars)	1,950,000	0	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 requirements.

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Authorizing Statute(s): US Code: 21 USC 301 et seq. Name of Law: Federal Food, Drug, and Cosmetic 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: 3

IC Title	Form No.	Form Name
OTC User Fee Program	FDA 5009	OVER-THE-COUNTER MONOGRAPH USER FEE COVER SHEET
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

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ICR Summary of Burden

	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	7,860	7,859	1	0	0	0
Annual Time Burden (Hours)	94,895	94,320	575	0	0	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: We estimate an additional 575 burden hours to the information collection resulting from provisions under CARES pertaining to OTC drug user fees. Upon implementation of the program we intend to offer a more definitive estimate of the anticipated number of respondents.

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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: 12/01/2020

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