Daily Rules, Proposed Rules, and Notices of the Federal Government
We are currently evaluating the safety and effectiveness of 13 active ingredients found eligible for possible addition to an OTC drug monograph via the TEA process described in 21 CFR 330.14. The ingredients under review are shown in table 1 of this document:
When our initial assessment of safety and effectiveness data for any of these ingredients is complete, we will prepare a proposed rule describing our conclusions, which may include a proposal to add the ingredient to an OTC drug monograph. Such an action would be subject to the National Environmental Policy Act of 1969 (NEPA). In order to comply with NEPA, we need data and information regarding the potential environmental impact if these ingredients are included in an OTC drug monograph, especially if this results in their use in drug products marketed in the United States for the first time (see section II of this document). We did not previously request such data and information for these 13 active ingredients. Therefore, we are requesting such data at this time. We cannot publish proposed rules for any of these 13 active ingredients until we receive this data and information.
As stated in 21 CFR 25.1, FDA regulations must comply with NEPA. To comply with NEPA, an environmental assessment (EA) of agency actions is required unless we determine that a categorical exclusion is warranted. Many actions on OTC drug monographs have been categorically excluded from the NEPA requirement for an EA under § 25.31(a) (21 CFR 25.31(a)), because, for active ingredients already marketed in the United States, the actions generally have not resulted in increased use of active ingredient. However, if we amend a monograph to include a new generally recognized as safe and effective (GRASE) active ingredient not previously marketed in the United States, this exclusion would not apply because our action would increase the use of the active ingredient. This situation may occur for active ingredients found eligible for inclusion in an OTC drug monograph under the TEA process on the basis of foreign marketing experience.
Active ingredients found eligible for potential inclusion in an OTC drug monograph under the TEA process might qualify for the categorical exclusions provided under § 25.31(b) or (c). These exclusions allow for active ingredients that will not exceed 1 part per billion (ppb) (1 microgram per liter) in the aquatic environment or active ingredients that naturally occur in the environment and do not alter significantly the concentration or distribution of the ingredient, its metabolites, or degradation products in the environment.
In order to determine whether any of the active ingredients found eligible for potential inclusion in an OTC monograph meet the requirements for any categorical exclusion, including § 25.31(b) or (c), or to prepare an EA, we need additional data and information. To assist the agency, we are requesting any information that would support the application of any categorical exclusion, or that would support the preparation of an EA, if necessary.
To estimate the expected introductory concentration of an ingredient or ingredients in the aquatic environment for purposes of § 25.31(b), please refer to section III of the CDER Guidance on Environmental Assessment of Human Drug and Biologic Applications (CDER EA Guidance Document). This guidance document can be viewed at
To complete an EA, we need information similar to that specified in section IV of the CDER EA Guidance Document (pages 9-27). We request that a submitter segregate any data or information that the submitter believes is protected from disclosure by 18 U.S.C. 1905 or 21 U.S.C. 331(j) or 360j(c). If such data or information is included in the submission, we request that the submitter summarize the information, to the extent possible, for public disclosure (see 21 CFR 25.50 and 25.51(a)).
Interested persons may submit to the Division of Dockets Management (see