Over-the-Counter Human Drugs; Labeling Requirements

Forms and Documents

Document Name	Status
SUPPORTING STATEMENT FINAL 12-17-13.doc Supporting Statement A	2013-12-17

IC Document Collections

IC ID	Document Title	Status
5943	Format and Content Requirements for Over--the-Counter Drug Product Labeling - 201.66(c) and (d) - New OTC Drug Products	Modified
209796	Format and Content Requirements -- Exemptions and Deferrals -- 201.66(e)	New
209795	Format and Content Requirements for Over-the-Counter Drug Product Labeling - 201.66(c)&(d) - New OTC Sunscreen Products	New

ICR Details

OMB Control No: 0910-0340	ICR Reference No: 201312-0910-009
Status: Historical Active	Previous ICR Reference No: 201008-0910-009
Agency/Subagency: HHS/FDA	Agency Tracking No: 21080
Title: Over-the-Counter Human Drugs; Labeling Requirements
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: 01/27/2014
	Date Received in OIRA: 12/20/2013
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2017	36 Months From Approved	01/31/2014
Responses	961	0	5,650
Time Burden (Hours)	11,523	0	14,303
Cost Burden (Dollars)	2,100,000	0	3,663,000

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Abstract: Regulations established in March 1999 (21 CFR 206.66) define format and content requirements for the labeling of over-the-counter (OTC)drug products. Specifically, these requirements apply to labeling within the Drug Facts panel required for all OTC drug products (i.e., "Drug Facts" labeling). All OTC drug products except sunscreens have been required to comply with the labeling requirements set forth in 21 CFR 206.66 since June 2005. Complying with these regulations imposes a burden on the manufacturers of new OTC drug products. The burden consists of preparing new labeling for these products that complies with the Drug Facts labeling requirements

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Authorizing Statute(s): US Code: 21 USC 201, 502, 503, 505, and 701 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:
	78 FR 44124	07/23/2013
30-day Notice:	Federal Register Citation:	Citation Date:
	78 FR 73197	12/05/2013
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
Format and Content Requirements for Over--the-Counter Drug Product Labeling - 201.66(c) and (d) - New OTC Drug Products
Format and Content Requirements for Over-the-Counter Drug Product Labeling - 201.66(c)&(d) - New OTC Sunscreen Products
Format and Content Requirements -- Exemptions and Deferrals -- 201.66(e)

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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	5,650	0	0	-4,689	0
Annual Time Burden (Hours)	11,523	14,303	0	0	-2,780	0
Annual Cost Burden (Dollars)	2,100,000	3,663,000	0	0	-1,563,000	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 previous burden estimate in 2011 was 14,303 hours. The decrease in burden to 11,523 (-2,780) hours is mostly attributed to a decrease in the number of manufacturers of sunscreen drug products and a corresponding decrease in the number of total annual burden for manufacturers of new products marketed under NDA, ANDAs, or OTC drug monographs used for the estimates under section 201.66(c) and (d). In addition, the respondents of sunscreen drug products has decreased from the estimate in 2011 from 400 to 20. Conversely, the hours per response increased from 9500 to 720.

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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: 12/20/2013

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