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 FINAL 0688 6-25-14.doc Supporting Statement A	2014-06-25

IC Document Collections

IC ID	Document Title	Status
197087	330.14 (c) and (d) - Time and Extent Application/Submission of Information; Confidentiality Other-Guidance	Modified
197086	330.14 (f) and (i) - Request for Data and Views/Compendial Monograph Other-Guidance	Modified

ICR Details

OMB Control No: 0910-0688	ICR Reference No: 201405-0910-020
Status: Historical Active	Previous ICR Reference No: 201105-0910-004
Agency/Subagency: HHS/FDA	Agency Tracking No: CDER
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: 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: 08/21/2014
	Date Received in OIRA: 06/25/2014
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2017	36 Months From Approved	08/31/2014
Responses	4	0	4
Time Burden (Hours)	7,750	0	7,750
Cost Burden (Dollars)	0	0	0

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Abstract: Interested parties (private sector businesses) may submit to the Food and Drug Administration (FDA) a request that an active ingredient or ingredients be included in the over-the-¬counter (OTC) drug monograph system. Such a request requires the submission of supporting information. FDA regulations set forth criteria and procedures by which OTC drugs that initially were marketed in the United States after the OTC drug review began in 1972 and OTC drugs without any U.S. marketing experience can be considered for inclusion in the OTC drug monograph system under the provisions of 21 CFR 330.14. The regulations establish a two-part process. First, to determine whether a drug product is eligible to be considered for inclusion in the OTC drug monograph system, certain information must be submitted in a time and extent application (TEA) to show that a drug product can meet the statutory standard of marketing to a material extent and for a material time. Second, if the drug product is found eligible to be considered for inclusion in the OTC drug monograph system, we will publish a notice of eligibility in the Federal Register that requests that interested persons submit data to demonstrate that the ingredient or ingredients can be classified as safe and effective (GRASE) for its OTC use(s) (21 CFR 330.14(e) and (f)). The submission of the safety and effectiveness information also requires the preparation of an environmental assessment. As stated in 21 CFR 25.1, our regulations must be administered in accordance with the policies set forth in the National Environmental Policy Act of 1969 (NEPA). To comply with NEPA, an environmental assessment (EA) of our actions is required unless we determine that a categorical exclusion is warranted (21 CFR 25.20(f) and 25.21). FDA uses the information collected to determine eligibility (first part of two-step process) and, if determined eligible, to classify the ingredient(s) as GRASE or not GRASE (second part of the process).

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Authorizing Statute(s): 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
   US Code: 21 USC 351 & 352 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:
	79 FR 16007	03/24/2014
30-day Notice:	Federal Register Citation:	Citation Date:
	79 FR 36070	06/25/2014
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) - Time and Extent Application/Submission of Information; Confidentiality
330.14 (f) and (i) - Request for Data and Views/Compendial Monograph

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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	4	0	0	0	0
Annual Time Burden (Hours)	7,750	7,750	0	0	0	0
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: 06/25/2014

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