Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded

Forms and Documents

Document Name	Status
Supporting Statement TEA mlk 1-25-11.doc Supporting Statement A	2011-05-18

IC Document Collections

IC ID	Document Title	Status
197087	330.14 (c) and (d)	Modified
197086	330.14 (f) and (i)	Modified

ICR Details

OMB Control No: 0910-0688	ICR Reference No: 201105-0910-004
Status: Historical Active	Previous ICR Reference No: 201103-0910-010
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Additional Criteria and Procedures for Classifying Over-the-Counter Drugs as Generally Recognized as Safe and Effective and Not Misbranded
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 06/13/2011
	Date Received in OIRA: 05/19/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2014	36 Months From Approved
Responses	4	0	0
Time Burden (Hours)	7,750	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA's legal authority to regulate the ingredients contained in over-the-counter (OTC) drug products derives from sections 321, 351, 352, 353, 355, 360, and 371 of the Federal Food, Drug, and Cosmetics Act (the act). FDA follows the procedures outlined in 21 CFR 330.10 for classifying active ingredients in OTC drug products as generally recognized as safe and effective (GRASE) and not misbranded

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Authorizing Statute(s): US Code: 21 USC 351 & 352 Name of Law: FFDCA
   US Code: 21 USC 321 Name of Law: FFDCA
   US Code: 21 USC 353 & 355 Name of Law: FFDCA
   US Code: 21 USC 360 Name of Law: FFDCA
   US Code: 21 USC 371 Name of Law: FFDCA
  

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:
	75 FR 62404	10/08/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 6801	02/08/2011
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
330.14 (c) and (d)
330.14 (f) and (i)

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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	4	0	0	0	0	4
Annual Time Burden (Hours)	7,750	0	0	0	0	7,750
Annual Cost Burden (Dollars)	0	0	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:

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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: 05/19/2011

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