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Daily Rules, Proposed Rules, and Notices of the Federal Government

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1996-N-0006] (formerly Docket No. 1996N-0277)

Safety and Efficacy Review for Additional Ingredients in Over-the-Counter Drug Products for Human Use; Request for Environmental Impact Data and Information

AGENCY: Food and Drug Administration, HHS.
ACTION: Request for data and information.
SUMMARY: We (Food and Drug Administration (FDA)) are requesting data and information regarding the potential environmental impact of amending over-the-counter (OTC) drug monographs to include certain active ingredients not previously marketed in the United States or marketed in the United States under approved applications after the OTC drug review began in 1972. Thirteen active ingredients have been found eligible for potential inclusion in OTC drug monographs based on time and extent applications (TEAs). We are currently evaluating the safety and effectiveness of these ingredients.
DATES: Submit data, information, and general comments by May 24, 2010.
ADDRESSES: Submit electronic or written data, information, and general comments in response to this document. Submit electronic comments tohttp://regulations.gov. Submit written comments to the Division of Dockets Management HFA-305), 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Michael L. Koenig, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 5411, Silver Spring, MD 20993-0002, 301-796-2090.
SUPPLEMENTARY INFORMATION: I. Ingredients Affected by This Notice

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:

Table 1.—List of active ingredients found eligible for possible addition to an OTC drug monograph Active Ingredient Monograph Docket No. Eligibility Amiloxate Sunscreen FDA-2003-N-0196 July 11, 2003, 68 FR 41386 Bemotrizinol Sunscreen FDA-2005-N-0453 December 5, 2005, 70 FR 72449 Bisoctrizole Sunscreen FDA-2005-N-0453 December 5, 2005, 70 FR 72449 Climbazole Dandruff FDA-2005-N-0021 December 5, 2005, 70 FR 72448 Diethylhexyl butamido triazone Sunscreen FDA-2006-O-0314 July 26, 2006, 71 FR 42405 Ecamsule1 Sunscreen FDA-2008-N-0474 September 12, 2008, 73 FR 53029 Enzacamene Sunscreen FDA-2003-N-0196 July 11, 2003, 68 FR 41386 Octyl triazone Sunscreen FDA-2003-N-0196 July 11, 2003, 68 FR 41386 Piroctone olamine Dandruff FDA-2004-N-0037 February 18, 2004, 69 FR 7652 Sodium picosulfate Laxative FDA-2006-O-0057 June 22, 2006, 71 FR 35917 Sodium shale oil sulfonate Dandruff FDA-2009-N-0146 April 7, 2009, 74 FR 15741 Triclosan Acne FDA-2005-N-0454 December 5, 2005, 70 FR 72447 Triclosan1 Antigingivitis/Antiplaque FDA-1981-N-0015 July 6, 2004, 69 FR 40640 1These ingredients are marketed under approved new drug applications (NDAs).

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.

II. Data Being Requested

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 athttp://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070561.pdf.

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)).

III. Submission of Data

Interested persons may submit to the Division of Dockets Management (seeADDRESSES) written or electronic data, information, and general comments. Submit a single copy of electronic data, information, and general comments or two paper copies of any mailed data, information, and general comments, except that individuals may submit one paper copy. Data, information, andgeneral comments are to be identified with the docket number found in brackets in the heading of this document. Received data, information, and general comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Dated: February 15, 2010. Leslie Kux, Acting Assistant Commissioner for Policy.