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

Forms and Documents

Document	Type	Status	Availability
0340 SS 2016 Extension.pdf	Supporting Statement A	Uploaded 2016-12-21	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		Modified
209796	Format and Content Requirements; exemptions and deferrals		Modified
209795	Format and Content Requirements for Over-the-Counter Drug Product Labeling; new OTC sunscreen products		Modified

ICR Details

OMB Control No: 0910-0340	ICR Reference No: 201612-0910-009
Status: Historical Active	Previous ICR Reference No: 201312-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
Title: Format and Content Requirements for Over-the-Counter Drug Product Labeling
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 01/23/2017
	Date Received in OIRA: 12/22/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved	01/31/2017
Responses	961	0	961
Time Burden (Hours)	11,523	0	11,523
Cost Burden (Dollars)	0	0	2,100,000

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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 Cosmetics Act
  

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:
	81 FR 18861	04/01/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 74452	10/26/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

IC Title	Form No.	Form Name
Format and Content Requirements for Over--the-Counter Drug Product Labeling; new OTC drug products
Format and Content Requirements for Over-the-Counter Drug Product Labeling; new OTC 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	961	961	0	0	0	0
Annual Time Burden (Hours)	11,523	11,523	0	0	0	0
Annual Cost Burden (Dollars)	0	2,100,000	0	-2,100,000	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:

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Annual Cost to Federal Government: $0

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 12/22/2016

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