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Safety and Effectiveness for Health Care Antiseptics; Topical

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Safety and Effectiveness for Health Care Antiseptics; Topical DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Safety and Effectiveness for Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use; Proposed Amendment of the Tentative Final Monograph; Reopening of Administrative Record Docket No. FDA-2015-N-0101 Preliminary Regulatory Impact Analysis Initial Regulatory Flexibility Analysis Unfunded Mandates Reform Act Analysis Economics Staff Office of Planning Office of Policy, Planning, Legislation, and Analysis Office of the Commissioner 1 Preface: Executive Summary of the Proposed Rule I. Introduction and Summary A. Introduction B. Summary of Costs and Benefits II. Preliminary Regulatory Impact Analysis A. Brief History of Health Care Antiseptics B. Background C. Need for Regulation D. Purpose of This Rule E. Baseline Conditions 1. Number of Active Ingredients and Affected Products In The Current Market for Health Care Antiseptics 2. Antiseptic Active Ingredient Usage in Health Care Antiseptic Products F Benefits 1. Benefits Assuming No Antiseptic Active Ingredient Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products a. Reducing Resistant Microbial Strains b. Reducing Adverse Health Effects of Antiseptic Usage c. Reducing Infections Associated Withc Using Non-GRAS/GRAE Health Care Antiseptics 2. Benefits Assuming Every Antiseptic Active Ingredient With Large Market Share Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products 3. Summary of Total Benefits G Costs 1. Reformulation and Relabeling 2 2. Testing a. GRAE Testing b. GRAS Testing 3. Exiting the Market 4. Costs Assuming Every Ingredient With Large Market Share Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products 5. Costs Assuming All Testing Is Completed and No Ingredient Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products 6. Summary of Total Costs H. Alternatives 1. Every Antiseptic Active Ingredient With Large Market Share Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products 2. No Antiseptic Active Ingredient Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products I. Cost Effectiveness 1. Every Antiseptic Active Ingredient With Large Market Share Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products 2. No Antiseptic Active Ingredient Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products III. Small Entity Effects A. Description and Number of Affected Small Entities B. Description of the Potential Impacts of the Proposed Rule on Small Entities 1. No Antiseptic Active Ingredient Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products 3 2. Every Antiseptic Active Ingredient With Large Market Share Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products C. Alternatives for Regulatory Relief 1. No Antiseptic Active Ingredient Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products a. Delay Testing Compliance One Year 2. Every Antiseptic Active Ingredient with Large Market Share Is Demonstrated To Be GRAS/GRAE for Use In Health Care Antiseptic Products a. Increase Relabeling Compliance Times IV.References 4 I. Introduction and Summary A. Introduction FDA has examined the impacts of the proposed rule under Executive Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive Orders 12866 and 13563 direct Agencies to assess all costs and benefits of available regulatory alternatives and, when regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety, and other advantages; distributive impacts; and equity). The Agency believes that this proposed rule is a significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires Agencies to analyze regulatory options that would minimize any significant impact of a rule on small entities. The proposed rule could impose significant economic burdens on a substantial number of small entities. Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires that Agencies prepare a written statement, which includes an assessment of anticipated costs and benefits, before proposing "any rule that includes any Federal mandate that may result in the expenditure by State, local, and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more (adjusted annually for inflation) in any one year." The current threshold after adjustment for inflation is $141 million, using the most current (2013) Implicit Price Deflator for the Gross Domestic Product. FDA expects that this rule could result in a 1-year expenditure that would meet or exceed this amount. 5 B. Summary of Costs and Benefits The proposed rule’s costs and benefits are summarized in table 1. Benefits are attributed to reducing the potential adverse health effects associated with using antiseptic active ingredients in the event that any active ingredient is not shown to be generally safe and effective for their intended use. Annual benefits are estimated to range between $0 and $0.16 million. We estimate the present value associated with $0.16 million of annual benefits, over a 10 year period, to approximately equal $0 to $1.4 million at a 3 percent discount rate, and $0 to $1.1 million at a 7 percent discount rate. Costs include the one-time costs associated with reformulating products, relabeling reformulated products, and conducting both safety and efficacy tests. Total upfront costs are estimated to range between $64.0 and $90.8 million. Annualizing these costs over a 10 year period, we estimate total annualized costs to range from $7.3 to $10.4 million at a 3 percent discount rate, and from $8.5 to $12.1 million at a 7 percent discount rate. 6 Table1. Economic Data: Costs and Benefits Statement Units Low High Category Primary Estimate Year Discount Period Notes Estimate Estimate Dollars Rate Covered Annualized Value of reduced Monetized 0.0 $0.08 $0.16 2013 7% 10 years number of adverse $millions/year events associated with using non- GRAS/GRAE Benefits Annualized antiseptic active Monetized 0.0 $0.08 $0.16 2013 3% 10 years ingredients. Range $millions/year of estimates captures uncertainty. Annualized Reduced antiseptic Quantified 0 10.3 20.6 7% 10 years active ingredient billion/year exposure (in Annualized milliliters). Range of Quantified 0 10.3 20.6 3% 10 years estimates captures billion/year uncertainty. Value of infection avoidance associated with switching from non-GRAS/GRAE antiseptic active ingredients to NDA Qualitative or ANDA antiseptics. Annualized Annualized costs of Monetized $8.5 $10.3 $12.1 2013 7% 10 years reformulating and $millions/year testing antiseptic Annualized products. Range of Monetized $7.3 $8.9 $10.4 2013 3% 10 years estimates captures $millions/year uncertainty. Annualized Quantified 7% Costs billion/year Annualized Quantified 3% billion/year Where the products affected by this proposed rule are currently chosen over NDA and ANDA alternatives (such as chlorhexidine products), a switch brought on by the rule may lead to search costs or other types of transactions Qualitative costs. In this scenario, there are also the potential costs associated with adverse reactions if patients are allergic to substitute products. Federal 7% Annualized Monetized 3% $millions/year From/To Transfers Other 7% Annualized Monetized 3% $millions/year From/To State, Local, or Tribal Government: Not applicable Small Business: The costs associated with potentially affected small entities range between 0.60 and 20.64 percent of their average annual revenues. Effects Wages: No estimated effect Growth: No estimated effect 7 II. Preliminary Regulatory Impact Analysis A. Brief History of Health Care Antiseptics Health care antiseptics are antimicrobial agents that are intended to reduce the number of micro-organisms on the skin. FDA recognizes 29 health care antiseptic active ingredients as being eligible for the over-the-counter (OTC) drug review, each of which it has proposed in the past to group into one of three categories. • Category I antiseptic active ingredients would be those that FDA had proposed, as part of a proposed rule in 1994, to determine, based on the available data, as generally recognized as safe and effective (GRAS/GRAE) for use in health care antiseptic products; • Category II antiseptic active ingredients would be those that FDA had proposed to determine to be not GRAS/GRAE for use in health care antiseptics; and finally, • Category III active antiseptic ingredients are those for which the Agency indicated that the available data were insufficient to determine that they were GRAS, GRAE, or both. This terminology has been taken from the OTC drug procedural regulations in 21 CFR s. 330.10. Antiseptics are marketed to consumers and various industries, such as research institutions, food handlers, textile manufacturers, and health care providers. This rule, however, only covers health care antiseptics, which are drug products that are intended for use by health care professionals in a hospital setting or other health care situations outside the hospital, but that are not identified as ‘first aid antiseptics’ in the 1991 First Aid Tentative Final Monograph (TFM). Health care antiseptics include patient preoperative skin preparations, surgical hand scrubs and rubs, and health care personnel hand washes and rubs. Currently marketed health care antiseptic products contain antiseptic active ingredients that were proposed to be classified under the 1994 tentative final monograph as either 8 category I or III. No currently marketed products contain antiseptic active ingredients that were proposed to be classified as category II in the 1994 TFM. Health care antiseptics are available as washes, rubs, and patient preoperative skin preparations. These products are usually packaged in either multiple use containers, such as bottles, or single-use applicators, such as wipes, swabs, and cotton pads.
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