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).
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:
(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;
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.
SUPPORTING STATEMENT FINAL 0688 6-25-14.doc
330.14 (c) and (d) - Time and Extent Application/Submission of Information; Confidentiality