Use of Ozone-Depleting Substances, 74298-74302 [2016-25851]

Download as PDF 74298 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Rules and Regulations AIRAC date State City Airport FDC No. FDC date 10-Nov-16 .......... GA Calhoun ............................ Tom B David Fld .............. 6/8369 9/15/16 10-Nov-16 .......... GA Calhoun ............................ Tom B David Fld .............. 6/8376 9/15/16 10-Nov-16 .......... GA Quitman ............................ Quitman Brooks County ... 6/8379 9/15/16 10-Nov-16 .......... GA Quitman ............................ Quitman Brooks County ... 6/8385 9/15/16 10-Nov-16 .......... GA Americus .......................... Jimmy Carter Rgnl ........... 6/8398 9/20/16 10-Nov-16 .......... GA Americus .......................... Jimmy Carter Rgnl ........... 6/8399 9/20/16 10-Nov-16 .......... KS Belleville ........................... Belleville Muni .................. 6/8459 9/8/16 10-Nov-16 .......... KS Belleville ........................... Belleville Muni .................. 6/8460 9/8/16 10-Nov-16 .......... 10-Nov-16 .......... KS IL Belleville ........................... Benton .............................. Belleville Muni .................. Benton Muni ..................... 6/8461 6/8578 9/8/16 9/13/16 10-Nov-16 .......... PA Meadville .......................... Port Meadville .................. 6/8885 9/7/16 [FR Doc. 2016–25785 Filed 10–25–16; 8:45 am] BILLING CODE 4910–13–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Part 2 [Docket No. FDA–2015–N–1355] RIN 0910–AH36 Use of Ozone-Depleting Substances AGENCY: Food and Drug Administration, HHS. ACTION: Direct final rule. The Food and Drug Administration (FDA, the Agency, or we) is amending its regulation on uses of ozone-depleting substances (ODSs), including chlorofluorocarbons (CFCs), to remove the designation for certain products as ‘‘essential uses’’ under the Clean Air Act. Essential-use products are exempt from the ban by FDA on the use of CFCs and other ODS propellants in FDA-regulated products and from the ban by the Environmental Protection Agency (EPA) on the use of ODSs in pressurized dispensers. The products that will no longer constitute an essential use are: Sterile aerosol talc administered intrapleurally by thoracoscopy for human use and metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. FDA is taking this action because alternative products that do not use ODSs are now available and because these products are no longer being marketed in versions that contain ODSs. DATES: This direct final rule is effective February 23, 2017. Submit either Lhorne on DSK30JT082PROD with RULES SUMMARY: VerDate Sep<11>2014 15:02 Oct 25, 2016 Jkt 241001 electronic or written comments on the direct final rule by December 27, 2016. If FDA receives no significant adverse comments within the specified comment period, the Agency will publish a document confirming the effective date of the final rule in the Federal Register within 30 days after the comment period on this direct final rule ends. If timely significant adverse comments are received, the Agency will publish a document in the Federal Register withdrawing this direct final rule before its effective date. ADDRESSES: You may submit comments as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: http:// www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to http:// www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else’s Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on http://www.regulations.gov. • If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the PO 00000 Frm 00020 Fmt 4700 Sfmt 4700 Subject RNAV (GPS) RWY 17, Amdt 1. RNAV (GPS) RWY 35, Amdt 1. RNAV (GPS) RWY 28, Amdt 1. RNAV (GPS) RWY 10, Amdt 1. RNAV (GPS) RWY 23, Amdt 1. RNAV (GPS) RWY 5, Amdt 1. RNAV (GPS) RWY 18, Orig-A. RNAV (GPS) RWY 36, Orig-A. VOR/DME–A, Amdt 3B. RNAV (GPS) RWY 18, Orig-A. LOC RWY 25, Amdt 6C. manner detailed (see ‘‘Written/Paper Submissions’’ and ‘‘Instructions’’). Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ‘‘Instructions.’’ Instructions: All submissions received must include the Docket No. FDA– 2015–N–1355 for ‘‘Use of OzoneDepleting Substances.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • Confidential Submissions—To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states ‘‘THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.’’ The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information E:\FR\FM\26OCR1.SGM 26OCR1 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Rules and Regulations Lhorne on DSK30JT082PROD with RULES redacted/blacked out, will be available for public viewing and posted on http:// www.regulations.gov. Submit both copies to the Division of Dockets Management. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as ‘‘confidential.’’ Any information marked as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 and other applicable disclosure law. For more information about FDA’s posting of comments to public dockets, see 80 FR 56469, September 18, 2015, or access the information at: http://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to http:// www.regulations.gov and insert the docket number, found in brackets in the heading of this document, into the ‘‘Search’’ box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6246, Silver Spring, MD 20993, 240–402–0979, daniel.orr@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background Production of ODSs has been phased out worldwide under the terms of the Montreal Protocol on Substances that Deplete the Ozone Layer (Montreal Protocol) (September 16, 1987, S. Treaty Doc. No. 10, 100th Cong., 1st sess., 26 I.L.M. 1541 (1987)). In accordance with the provisions of the Montreal Protocol, under authority of Title VI of the Clean Air Act (section 601 et seq.), the manufacture of ODSs, including CFCs, in the United States was generally banned as of January 1, 1996. To receive permission to manufacture CFCs in the United States after the phase-out date, manufacturers must obtain an exemption from the phase-out requirements from the parties to the Montreal Protocol. Procedures for securing an essential-use exemption under the Montreal Protocol are described in a request by EPA for applications for exemptions (60 FR 54349, October 23, 1995). Firms that wish to use ODSs manufactured after the phase-out date in VerDate Sep<11>2014 15:02 Oct 25, 2016 Jkt 241001 medical devices (as defined in section 601(8) of the Clean Air Act) (42 U.S.C. 7671(8)) covered under section 610 of the Clean Air Act (42 U.S.CC. 7671i) must receive exemptions for essential uses under the Montreal Protocol. EPA regulations implementing the provisions of section 610 of the Clean Air Act contain a general ban on the use of ODSs in pressurized dispensers, such as metered-dose inhalers (MDIs) (40 CFR 82.64(c) and 82.66(d)). These EPA regulations exempt from the general ban ‘‘medical devices’’ that FDA considers essential and that are listed in § 2.125(e) (21 CFR 2.125(e)). Section 601(8) of the Clean Air Act defines ‘‘medical device’’ as any device (as defined in the Federal Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 321)), diagnostic product, drug (as defined in the FD&C Act), and drug delivery system, if such device, diagnostic product, drug, or drug delivery system uses a class I or class II ODS for which no safe and effective alternative has been developed (and where necessary, has been approved by the Commissioner of Food and Drugs), and if such device, diagnostic product, drug, or drug delivery system has, after notice and opportunity for public comment, been approved and determined to be essential by the Commissioner in consultation with the Administrator of EPA. Class I substances include CFCs, halons, carbon tetrachloride, methyl chloroform, methyl bromide, and other chemicals not relevant to this document (see 40 CFR part 82, appendix A to subpart A). Class II substances include hydrochlorofluorocarbons (see 40 CFR part 82, appendix B to subpart A). A drug, device, cosmetic, or food contained in an aerosol product or other pressurized dispenser that releases a CFC or other ODS propellant is generally not considered an essential use of the ODS under the Clean Air Act except as provided in § 2.125(c) and (e). This prohibition is based on scientific research indicating that CFCs and other ODSs reduce the amount of ozone in the stratosphere and thereby increase the amount of ultraviolet radiation reaching the Earth. An increase in ultraviolet radiation will increase the incidence of skin cancer and produce other adverse effects of unknown magnitude on humans, animals, and plants (80 FR 36937, June 29, 2015). Section 2.125(c) and (e) provide exemptions for essential uses of ODSs for certain products containing ODS propellants that FDA determines provide unique health benefits that would not be available without the use of an ODS. Faced with the statutorily mandated phase-out of the production of ODSs, PO 00000 Frm 00021 Fmt 4700 Sfmt 4700 74299 drug manufacturers have developed alternatives to MDIs and other selfpressurized drug dosage forms that do not contain ODSs. Examples of these alternative dosage forms are MDIs that use non-ODSs as propellants and drypowder inhalers. The availability of alternatives to ODSs means that certain drug products listed in § 2.125(e) are no longer essential uses of ODSs. Therefore, due to lack of marketing of approved products containing ODSs, and the availability of alternative products that do not contain ODSs, FDA is amending its regulations to remove essential-use designations for sterile aerosol talc administered intrapleurally by thoracoscopy for human use (§ 2.125(e)(4)(ix)) and for metered-dose atropine sulfate aerosol human drugs administered by oral inhalation (§ 2.125(e)(4)(vi)). There is currently one sterile aerosol talc product containing ODSs that is approved for administration intrapleurally by thoracoscopy for human use for the treatment of recurrent malignant pleural effusion in symptomatic patients. Section 2.125(g) sets forth standards for determining whether the use of an ODS in a medical product is no longer essential. Under § 2.125(g)(3), an essential-use designation for individual active moieties marketed as ODS products and represented by one new drug application may no longer be essential if: • At least one non-ODS product with the same active moiety is marketed with the same route of administration, for the same indication, and with approximately the same level of convenience of use as the ODS product containing that active moiety; • Supplies and production capacity for the non-ODS product(s) exist or will exist at levels sufficient to meet patient need; • Adequate U.S. postmarketing-use data are available for the non-ODS product(s); and • Patients who medically require the ODS product are adequately served by the non-ODS product(s) containing that active moiety and other available products (§ 2.125(g)(3)). On June 29, 2015, FDA published a notice and request for comment concerning its tentative conclusion that sterile aerosol talc administered intrapleurally by thoracoscopy for human use no longer constitutes an essential use under the Clean Air Act under the criteria in § 2.125(g)(3). FDA requested comment on its findings that sterile aerosol talc is currently marketed for intrapleural administration in two non-ODS formulations and on its E:\FR\FM\26OCR1.SGM 26OCR1 74300 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Rules and Regulations finding that the route of administration, indications, and level of convenience appear to be the same for the ODS and non-ODS formulations of sterile aerosol talc. FDA also requested comment on its finding that the non-ODS products are available in sufficient quantities to serve the current patient population. FDA received no comments on these findings or on its tentative conclusion that sterile aerosol talc administered intrapleurally by thoracoscopy for human use no longer constitutes an essential use of ODSs under the Clean Air Act. In the same document published on June 29, 2015, FDA requested comments concerning its tentative conclusion that metered-dose atropine sulfate aerosol human drugs administered by oral inhalation no longer constitute an essential use under the Clean Air Act under the criteria in § 2.125(g)(1). FDA requested comment concerning its finding that metered-dose atropine sulfate aerosol human drugs administered by oral inhalation are no longer marketed in an approved ODS formulation. Under § 2.125(g)(1), an active moiety may no longer constitute an essential use (§ 2.125(e)) if it is no longer marketed in an approved ODS formulation. The failure to market indicates nonessentiality because the absence of a demand sufficient for even one company to market the product is highly indicative that the use is not essential. FDA received no comments concerning its finding that metered-dose atropine sulfate aerosol human drugs administered by oral inhalation are no longer marketed in an ODS formulation or concerning its tentative conclusion that these drugs no longer constitute an essential use of ODSs under the Clean Air Act. Accordingly, FDA is amending its regulation to remove sterile aerosol talc administered intrapleurally by thoracoscopy for human use (§ 2.125(e)(4)(ix)) and to remove metered-dose atropine sulfate aerosol human drugs administered by oral inhalation (§ 2.125(e)(4)(vi)) as essential uses under the Clean Air Act. Lhorne on DSK30JT082PROD with RULES II. Direct Final Rulemaking FDA has determined that the subject of this rulemaking is suitable for a direct final rule. FDA is amending § 2.125 to remove essential-use designations for sterile aerosol talc administered intrapleurally by thoracoscopy for human use and for metered-dose atropine sulfate aerosol human drugs administered by oral inhalation. This rule is intended to make noncontroversial changes to existing regulations. The Agency does not VerDate Sep<11>2014 15:02 Oct 25, 2016 Jkt 241001 anticipate receiving any significant adverse comment on this rule. Consistent with FDA’s procedures on direct final rulemaking, we are publishing elsewhere in this issue of the Federal Register a companion proposed rule. The companion proposed rule and this direct final rule are substantively identical. The companion proposed rule provides the procedural framework within which the proposed rule may be finalized in the event the direct final rule is withdrawn because of any significant adverse comment. The comment period for this direct final rule runs concurrently with the comment period of the companion proposed rule. Any comments received in response to the companion proposed rule will also be considered as comments regarding this direct final rule. FDA is providing a comment period for the direct final rule of 60 days after the date of publication in the Federal Register. If we receive any significant adverse comment, we intend to withdraw this direct final rule before its effective date by publishing a notice in the Federal Register within 30 days after the comment period ends. A significant adverse comment explains why the rule either would be inappropriate, including challenges to the rule’s underlying premise or approach, or would be ineffective or unacceptable without a change. In determining whether an adverse comment is significant and warrants withdrawing a direct final rule, the Agency will consider whether the comment raises an issue serious enough to warrant a substantive response in a notice-and-comment process in accordance with section 553 of the Administrative Procedure Act (5 U.S.C. 553). Comments that are frivolous, insubstantial, or outside the scope of the direct final rule will not be considered significant or adverse under this procedure. For example, a comment recommending a regulation change in addition to the changes in the direct final rule would not be considered a significant adverse comment unless the comment states why the rule would be ineffective without the additional change. In addition, if a significant adverse comment applies to an amendment, paragraph, or section of this rule and that provision can be severed from the remainder of the rule, FDA may adopt as final the provisions of the rule that are not the subject of a significant adverse comment. If FDA does not receive any significant adverse comment in response to the direct final rule, the Agency will publish a document in the PO 00000 Frm 00022 Fmt 4700 Sfmt 4700 Federal Register confirming the effective date of the final rule. The Agency intends to make the direct final rule effective 30 days after publication of the confirmation document in the Federal Register. A full description of FDA’s policy on direct final rule procedures may be found in a guidance for FDA and industry entitled ‘‘Direct Final Rule Procedures’’ (available on http:// www.fda.gov/RegulatoryInformation/ Guidances/ucm125166.htm) that was announced in the Federal Register of November 21, 1997 (62 FR 62466). III. Economic Analysis of Impacts A. Introduction We have examined the impacts of the direct final 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 (Pub. L. 104–4). Executive Orders 12866 and 13563 direct us 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). We have developed a comprehensive Economic Analysis of Impacts that assesses the impacts of the proposed rule. We believe that this final rule is not a significant regulatory action as defined by Executive Order 12866. The Regulatory Flexibility Act requires us to analyze regulatory options that would minimize any significant impact of a rule on small entities. We certify that the direct final rule will not have a significant economic impact on a substantial number of small entities. The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires us to prepare a written statement, which includes an assessment of anticipated costs and benefits, before issuing ‘‘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 $146 million, using the most current (2015) Implicit Price Deflator for the Gross Domestic Product. This direct final rule would not result in an expenditure in any year that meets or exceeds this amount. B. Need for the Regulation This rule is necessary to comply with the Montreal Protocol under authority of E:\FR\FM\26OCR1.SGM 26OCR1 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Rules and Regulations Title VI of the Clean Air Act (section 601 et seq.), which banned the manufacture of ODSs, including CFCs, to reduce the depletion of the ozone layer in the United States as of January 1, 1996. EPA regulations exempted from the ban medical devices, diagnostic products, drugs, and drug delivery systems that FDA considered essential and that are listed in § 2.125(e) when they use a class I or class II ODS for which no safe and effective alternative has been developed. The direct final rule would remove the exemptions for sterile aerosol talc products and for metered-dose atropine sulfate aerosol human drugs containing ODSs. There is currently at least one sterile aerosol talc product not containing ODSs approved for the administration intrapleurally by thoracoscopy for human use that is a safe and effective alternative, and which meets the criteria outlined in § 2.125(g)(3). Accordingly, the sterile aerosol talc product containing ODSs no longer meets the requirements for an essential use and should no longer be exempted from the ban. Metered-dose atropine sulfate aerosol human drugs administered by oral inhalation are no longer available in the product market in an approved ODS formulation. The current absence of the product in the market indicates both a lack of demand for the product and that the product is nonessential, under § 2.125(g)(1). With the adoption of this direct final rule, the manufacturer of the sterile aerosol talc with ODSs and any potential future manufacturers of metered-dose atropine sulfate aerosols will have notice of the requirements to comply with the ban of products from containing ODSs. C. Benefits and Costs 1. Number of Affected Entities The affected entities covered by this direct final rule are the manufacturing facilities of the products that would have exemptions from the ban removed. Only one manufacturer, the Bryan Corporation that manufactures the sterile aerosol talc product containing ODSs at a single facility, would be affected. Currently, there are no manufacturers of metered-dose atropine sulfate aerosols. Lhorne on DSK30JT082PROD with RULES 2. Costs The potential social costs from removing the exemptions are (1) the costs to patient consumers or to their insurers for paying a higher price for alternative non-ODS formulations of sterile aerosol talc products and (2) the costs for disposing of and destroying VerDate Sep<11>2014 15:02 Oct 25, 2016 Jkt 241001 any remaining product inventory that remains after the effective date of the direct final rule. We lack data about the remaining stocks of product inventory that are likely to remain after the effective date of the direct final rule and the relative price that consumers or their insurers would pay. Because significant notice has been given to the manufacturer about the impending removal of the exemptions, we do not believe a significant stock of inventory will remain for the sterile aerosol talc product. The most recent publically available information shows that the annual revenues for Bryan Corporation are about $10 million (Ref. 1). Public information about this company shows that it manufactures three different surgical and medical instruments including the talc. If total profits for the exempt talc product are 10 percent of the total annual revenues, and if total revenues are exclusively from the exempt talc, then $1 million represents an upper bound for the total social cost of removing the sterile aerosol talc product from the market. Because it is unlikely that their total profits are exclusively from the sterile aerosol talc, it is more likely that the foregone profits are at most one-third of the $1 million; in fact, the true social cost could be significantly less than the total foregone profit of this product. Metered-dose atropine sulfate aerosol human drugs that would be affected by this rule are no longer marketed; consequently, removal of the exemption for this product would not present the public, consumers, insurers, or producers with any costs. 3. Health Benefits The direct final rule implements the requirements of the Clean Air Act that ban the use of products containing ODSs that no longer meet the requirements for essential use. The social benefits of the direct final rule derive from greater compliance with the Clean Air Act. The ODSs that either would have been emitted by sterile aerosol talcs that contain them, or from potential market entrants that would have manufactured metered-dose atropine sulfate aerosols that contain ODSs will no longer be emitting them, which will help reduce the depletion of the ozone layer and the ultraviolet radiation reaching the Earth. We lack the ability to quantify the health benefits from the reduced exposure to and from the reduced risk associated with ultraviolet light that result from removing the exemptions to the ban. Because the change in exposure and resulting risk from the final rule is likely to be small, the incremental health PO 00000 Frm 00023 Fmt 4700 Sfmt 4700 74301 impact is likely to be too small to measure. D. Economic Summary The direct final rule will remove the exemptions for sterile aerosol talc products and for metered-dose atropine sulfate aerosol human drugs containing ODSs. The primary public health benefit from adoption of the direct final rule is to reduce the depletion of the ozone layer to decrease human exposure to ultraviolet radiation. The reduction in exposure to ultraviolet radiation because of the direct rule is likely to be too small to measure. The potential social costs of the direct final rule would occur if patient consumers or their health care insurers would have to pay more for otherwise comparable products and if the product manufacturers would have to safely destroy any remaining product inventories after the effective date of the rule. We estimate that the social cost of the direct final rule is likely to be significantly less than $1 million but no more than the upper bound estimate of the foregone annual profit of the company that manufactures the sterile aerosol talc or $1 million. Because the metered-dose atropine sulfate aerosol is not currently in the market, there would be no social cost for removing its exemption from the ban. Imposing no new federal requirement is the baseline for a regulatory analysis. With no new regulation, there are no compliance costs or benefits to the direct final rule. However, because sterile aerosol talc is no longer an essential use of ODSs, under the Clean Air Act, there is no longer a pathway for sterile aerosol talc products containing ODSs to remain on the market. IV. Final Regulatory Flexibility Analysis FDA has examined the economic implications of the direct final rule as required by the Regulatory Flexibility Act. If a rule will have a significant economic impact on a substantial number of small entities, the Regulatory Flexibility Act requires Agencies to analyze regulatory options that would lessen the economic effect of the rule on small entities. We certify that the direct final rule will not have a significant economic impact on a substantial number of small entities. This analysis, together with other relevant sections of this document, serves as the final regulatory flexibility analysis, as required under the Regulatory Flexibility Act. E:\FR\FM\26OCR1.SGM 26OCR1 74302 Federal Register / Vol. 81, No. 207 / Wednesday, October 26, 2016 / Rules and Regulations V. Analysis of Environmental Impact We have determined under 21 CFR 25.30(h) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required. VI. Paperwork Reduction Act of 1995 FDA concludes that this direct final rule contains no collection of information. Therefore, clearance by the Office of Management and Budget under the Paperwork Reduction Act of 1995 is not required. VII. Federalism We have analyzed this final rule in accordance with the principles set forth in Executive Order 13132. We have determined that this final rule does not contain policies that have substantial direct effects on the States, on the relationship between the National Government and the States, or on the distribution of power and responsibilities among the various levels of government. Accordingly, we conclude that the rule does not contain policies that have federalism implications as defined in the Executive order and, consequently, a federalism summary impact statement is not required. VIII. References The following reference is on display in the Division of Dockets Management (see ADDRESSES) and is available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; it is also available electronically at http://www.regulations.gov. FDA has verified the Web site address as of the date this document publishes in the Federal Register, but Web sites are subject to change over time. Lhorne on DSK30JT082PROD with RULES 1. Bryan Corporation (http:// listings.findthecompany.com/l/ 12165972/Bryan-Corporation-inWoburn-MA, accessed on February 24, 2016). List of Subjects in 21 CFR Part 2 Administrative practice and procedure, Cosmetics, Drugs, Foods. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 2 is amended as follows: PART 2—GENERAL ADMINISTRATIVE RULINGS AND DECISIONS 1. The authority citation for part 2 continues to read as follows: ■ VerDate Sep<11>2014 15:02 Oct 25, 2016 Jkt 241001 Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342, 343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42 U.S.C. 7671 et seq. § 2.125 [Amended] 2. In § 2.125, remove and reserve paragraphs (e)(4)(vi) and (ix). ■ Dated: October 20, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–25851 Filed 10–25–16; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF THE INTERIOR Office of Surface Mining Reclamation and Enforcement 30 CFR Part 901 [SATS No. AL–079–FOR; Docket ID: OSMRE–2016–0005; S1D1S SS08011000 SX064A000 178S180110; S2D2S SS08011000 SX064A000 17XS501520] Alabama Regulatory Program Office of Surface Mining Reclamation and Enforcement, Interior. ACTION: Final rule; approval of amendment. AGENCY: We, the Office of Surface Mining Reclamation and Enforcement (OSMRE), are approving an amendment to the Alabama regulatory program (Alabama program) under the Surface Mining Control and Reclamation Act of 1977 (SMCRA or the Act). Alabama proposed revisions to its Program to closely follow the Federal regulations regarding awarding of appropriate costs and expenses including attorneys’ fees. Alabama is revising its program to be no less effective than the Federal regulations. DATES: Effective Date: October 26, 2016. FOR FURTHER INFORMATION CONTACT: Sherry Wilson, Director, Birmingham Field Office, Office of Surface Mining Reclamation and Enforcement, 135 Gemini Circle, Suite 215, Homewood, AL 35209. Telephone: (205) 290–7282. Email: swilson@osmre.gov. SUPPLEMENTARY INFORMATION: SUMMARY: I. Background on the Alabama Program II. Submission of the Amendment III. OSMRE’s Findings IV. Summary and Disposition of Comments V. OSMRE’s Decision VI. Procedural Determinations I. Background on the Alabama Program Section 503(a) of the Act permits a State to assume primacy for the regulation of surface coal mining and reclamation operations on non-Federal and non-Indian lands within its borders PO 00000 Frm 00024 Fmt 4700 Sfmt 4700 by demonstrating that its program includes, among other things, State laws and regulations that govern surface coal mining and reclamation operations in accordance with the Act and consistent with the Federal regulations. See 30 U.S.C. 1253(a)(1) and (7). On the basis of these criteria, the Secretary of the Interior conditionally approved the Alabama program effective May 20, 1982. You can find background information on the Alabama program, including the Secretary’s findings, the disposition of comments, and the conditions of approval of the Alabama program in the May 20, 1982, Federal Register (47 FR 22030). You can also find later actions concerning the Alabama program and program amendments at 30 CFR 901.10 and 901.15. II. Submission of the Amendment By letter dated March 18, 2016 (Administrative Record No. AL–0669), Alabama sent us an amendment to its program under SMCRA (30 U.S.C. 1201 et seq.) at its own initiative. We announced receipt of the proposed amendment in the May 20, 2016, Federal Register (81 FR 31881). In the same document, we opened the public comment period and provided an opportunity for a public hearing or meeting on the adequacy of the amendment. We did not hold a public hearing or meeting because no one requested one. The public comment period ended on June 20, 2016. We received one public comment (Administrative Record No. AL–0669– 04) that is addressed in the ‘‘Public Comments’’ section of part IV. Summary and Disposition of Comments. III. OSMRE’s Findings We are approving the amendment as described below. The following are the findings we made concerning Alabama’s amendment under SMCRA and the Federal regulations at 30 CFR 732.15 and 732.17. Any revisions that we do not specifically discuss below concerning non-substantive wording or editorial changes can be found in the full text of the program amendment available at www.regulations.gov. 1. Alabama Code 880–X–5A–.35— Assessment of Costs Alabama revised this section to allow any party the opportunity to be awarded costs and expenses by a final appellate body. Additionally, language was added to protect the public by including a ‘‘bad faith’’ clause so that expenses may only be assessed against any person in favor of the permittee or the regulatory authority upon demonstration that the E:\FR\FM\26OCR1.SGM 26OCR1

Agencies

[Federal Register Volume 81, Number 207 (Wednesday, October 26, 2016)]
[Rules and Regulations]
[Pages 74298-74302]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-25851]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 2

[Docket No. FDA-2015-N-1355]
RIN 0910-AH36


Use of Ozone-Depleting Substances

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
amending its regulation on uses of ozone-depleting substances (ODSs), 
including chlorofluorocarbons (CFCs), to remove the designation for 
certain products as ``essential uses'' under the Clean Air Act. 
Essential-use products are exempt from the ban by FDA on the use of 
CFCs and other ODS propellants in FDA-regulated products and from the 
ban by the Environmental Protection Agency (EPA) on the use of ODSs in 
pressurized dispensers. The products that will no longer constitute an 
essential use are: Sterile aerosol talc administered intrapleurally by 
thoracoscopy for human use and metered-dose atropine sulfate aerosol 
human drugs administered by oral inhalation. FDA is taking this action 
because alternative products that do not use ODSs are now available and 
because these products are no longer being marketed in versions that 
contain ODSs.

DATES: This direct final rule is effective February 23, 2017. Submit 
either electronic or written comments on the direct final rule by 
December 27, 2016. If FDA receives no significant adverse comments 
within the specified comment period, the Agency will publish a document 
confirming the effective date of the final rule in the Federal Register 
within 30 days after the comment period on this direct final rule ends. 
If timely significant adverse comments are received, the Agency will 
publish a document in the Federal Register withdrawing this direct 
final rule before its effective date.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No. 
FDA-2015-N-1355 for ``Use of Ozone-Depleting Substances.'' Received 
comments will be placed in the docket and, except for those submitted 
as ``Confidential Submissions,'' publicly viewable at http://www.regulations.gov or at the Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information

[[Page 74299]]

redacted/blacked out, will be available for public viewing and posted 
on http://www.regulations.gov. Submit both copies to the Division of 
Dockets Management. If you do not wish your name and contact 
information to be made publicly available, you can provide this 
information on the cover sheet and not in the body of your comments and 
you must identify this information as ``confidential.'' Any information 
marked as ``confidential'' will not be disclosed except in accordance 
with 21 CFR 10.20 and other applicable disclosure law. For more 
information about FDA's posting of comments to public dockets, see 80 
FR 56469, September 18, 2015, or access the information at: http://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Daniel Orr, Center for Drug Evaluation 
and Research, Food and Drug Administration, 10903 New Hampshire Ave., 
Bldg. 51, Rm. 6246, Silver Spring, MD 20993, 240-402-0979, 
daniel.orr@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

I. Background

    Production of ODSs has been phased out worldwide under the terms of 
the Montreal Protocol on Substances that Deplete the Ozone Layer 
(Montreal Protocol) (September 16, 1987, S. Treaty Doc. No. 10, 100th 
Cong., 1st sess., 26 I.L.M. 1541 (1987)). In accordance with the 
provisions of the Montreal Protocol, under authority of Title VI of the 
Clean Air Act (section 601 et seq.), the manufacture of ODSs, including 
CFCs, in the United States was generally banned as of January 1, 1996. 
To receive permission to manufacture CFCs in the United States after 
the phase-out date, manufacturers must obtain an exemption from the 
phase-out requirements from the parties to the Montreal Protocol. 
Procedures for securing an essential-use exemption under the Montreal 
Protocol are described in a request by EPA for applications for 
exemptions (60 FR 54349, October 23, 1995).
    Firms that wish to use ODSs manufactured after the phase-out date 
in medical devices (as defined in section 601(8) of the Clean Air Act) 
(42 U.S.C. 7671(8)) covered under section 610 of the Clean Air Act (42 
U.S.CC. 7671i) must receive exemptions for essential uses under the 
Montreal Protocol. EPA regulations implementing the provisions of 
section 610 of the Clean Air Act contain a general ban on the use of 
ODSs in pressurized dispensers, such as metered-dose inhalers (MDIs) 
(40 CFR 82.64(c) and 82.66(d)). These EPA regulations exempt from the 
general ban ``medical devices'' that FDA considers essential and that 
are listed in Sec.  2.125(e) (21 CFR 2.125(e)). Section 601(8) of the 
Clean Air Act defines ``medical device'' as any device (as defined in 
the Federal Food, Drug and Cosmetic Act (the FD&C Act) (21 U.S.C. 
321)), diagnostic product, drug (as defined in the FD&C Act), and drug 
delivery system, if such device, diagnostic product, drug, or drug 
delivery system uses a class I or class II ODS for which no safe and 
effective alternative has been developed (and where necessary, has been 
approved by the Commissioner of Food and Drugs), and if such device, 
diagnostic product, drug, or drug delivery system has, after notice and 
opportunity for public comment, been approved and determined to be 
essential by the Commissioner in consultation with the Administrator of 
EPA. Class I substances include CFCs, halons, carbon tetrachloride, 
methyl chloroform, methyl bromide, and other chemicals not relevant to 
this document (see 40 CFR part 82, appendix A to subpart A). Class II 
substances include hydrochlorofluorocarbons (see 40 CFR part 82, 
appendix B to subpart A).
    A drug, device, cosmetic, or food contained in an aerosol product 
or other pressurized dispenser that releases a CFC or other ODS 
propellant is generally not considered an essential use of the ODS 
under the Clean Air Act except as provided in Sec.  2.125(c) and (e). 
This prohibition is based on scientific research indicating that CFCs 
and other ODSs reduce the amount of ozone in the stratosphere and 
thereby increase the amount of ultraviolet radiation reaching the 
Earth. An increase in ultraviolet radiation will increase the incidence 
of skin cancer and produce other adverse effects of unknown magnitude 
on humans, animals, and plants (80 FR 36937, June 29, 2015). Section 
2.125(c) and (e) provide exemptions for essential uses of ODSs for 
certain products containing ODS propellants that FDA determines provide 
unique health benefits that would not be available without the use of 
an ODS.
    Faced with the statutorily mandated phase-out of the production of 
ODSs, drug manufacturers have developed alternatives to MDIs and other 
self-pressurized drug dosage forms that do not contain ODSs. Examples 
of these alternative dosage forms are MDIs that use non-ODSs as 
propellants and dry-powder inhalers. The availability of alternatives 
to ODSs means that certain drug products listed in Sec.  2.125(e) are 
no longer essential uses of ODSs. Therefore, due to lack of marketing 
of approved products containing ODSs, and the availability of 
alternative products that do not contain ODSs, FDA is amending its 
regulations to remove essential-use designations for sterile aerosol 
talc administered intrapleurally by thoracoscopy for human use (Sec.  
2.125(e)(4)(ix)) and for metered-dose atropine sulfate aerosol human 
drugs administered by oral inhalation (Sec.  2.125(e)(4)(vi)).
    There is currently one sterile aerosol talc product containing ODSs 
that is approved for administration intrapleurally by thoracoscopy for 
human use for the treatment of recurrent malignant pleural effusion in 
symptomatic patients. Section 2.125(g) sets forth standards for 
determining whether the use of an ODS in a medical product is no longer 
essential. Under Sec.  2.125(g)(3), an essential-use designation for 
individual active moieties marketed as ODS products and represented by 
one new drug application may no longer be essential if:
     At least one non-ODS product with the same active moiety 
is marketed with the same route of administration, for the same 
indication, and with approximately the same level of convenience of use 
as the ODS product containing that active moiety;
     Supplies and production capacity for the non-ODS 
product(s) exist or will exist at levels sufficient to meet patient 
need;
     Adequate U.S. postmarketing-use data are available for the 
non-ODS product(s); and
     Patients who medically require the ODS product are 
adequately served by the non-ODS product(s) containing that active 
moiety and other available products (Sec.  2.125(g)(3)).
    On June 29, 2015, FDA published a notice and request for comment 
concerning its tentative conclusion that sterile aerosol talc 
administered intrapleurally by thoracoscopy for human use no longer 
constitutes an essential use under the Clean Air Act under the criteria 
in Sec.  2.125(g)(3). FDA requested comment on its findings that 
sterile aerosol talc is currently marketed for intrapleural 
administration in two non-ODS formulations and on its

[[Page 74300]]

finding that the route of administration, indications, and level of 
convenience appear to be the same for the ODS and non-ODS formulations 
of sterile aerosol talc. FDA also requested comment on its finding that 
the non-ODS products are available in sufficient quantities to serve 
the current patient population. FDA received no comments on these 
findings or on its tentative conclusion that sterile aerosol talc 
administered intrapleurally by thoracoscopy for human use no longer 
constitutes an essential use of ODSs under the Clean Air Act.
    In the same document published on June 29, 2015, FDA requested 
comments concerning its tentative conclusion that metered-dose atropine 
sulfate aerosol human drugs administered by oral inhalation no longer 
constitute an essential use under the Clean Air Act under the criteria 
in Sec.  2.125(g)(1). FDA requested comment concerning its finding that 
metered-dose atropine sulfate aerosol human drugs administered by oral 
inhalation are no longer marketed in an approved ODS formulation. Under 
Sec.  2.125(g)(1), an active moiety may no longer constitute an 
essential use (Sec.  2.125(e)) if it is no longer marketed in an 
approved ODS formulation. The failure to market indicates 
nonessentiality because the absence of a demand sufficient for even one 
company to market the product is highly indicative that the use is not 
essential. FDA received no comments concerning its finding that 
metered-dose atropine sulfate aerosol human drugs administered by oral 
inhalation are no longer marketed in an ODS formulation or concerning 
its tentative conclusion that these drugs no longer constitute an 
essential use of ODSs under the Clean Air Act.
    Accordingly, FDA is amending its regulation to remove sterile 
aerosol talc administered intrapleurally by thoracoscopy for human use 
(Sec.  2.125(e)(4)(ix)) and to remove metered-dose atropine sulfate 
aerosol human drugs administered by oral inhalation (Sec.  
2.125(e)(4)(vi)) as essential uses under the Clean Air Act.

II. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable 
for a direct final rule. FDA is amending Sec.  2.125 to remove 
essential-use designations for sterile aerosol talc administered 
intrapleurally by thoracoscopy for human use and for metered-dose 
atropine sulfate aerosol human drugs administered by oral inhalation. 
This rule is intended to make noncontroversial changes to existing 
regulations. The Agency does not anticipate receiving any significant 
adverse comment on this rule.
    Consistent with FDA's procedures on direct final rulemaking, we are 
publishing elsewhere in this issue of the Federal Register a companion 
proposed rule. The companion proposed rule and this direct final rule 
are substantively identical. The companion proposed rule provides the 
procedural framework within which the proposed rule may be finalized in 
the event the direct final rule is withdrawn because of any significant 
adverse comment. The comment period for this direct final rule runs 
concurrently with the comment period of the companion proposed rule. 
Any comments received in response to the companion proposed rule will 
also be considered as comments regarding this direct final rule.
    FDA is providing a comment period for the direct final rule of 60 
days after the date of publication in the Federal Register. If we 
receive any significant adverse comment, we intend to withdraw this 
direct final rule before its effective date by publishing a notice in 
the Federal Register within 30 days after the comment period ends. A 
significant adverse comment explains why the rule either would be 
inappropriate, including challenges to the rule's underlying premise or 
approach, or would be ineffective or unacceptable without a change. In 
determining whether an adverse comment is significant and warrants 
withdrawing a direct final rule, the Agency will consider whether the 
comment raises an issue serious enough to warrant a substantive 
response in a notice-and-comment process in accordance with section 553 
of the Administrative Procedure Act (5 U.S.C. 553).
    Comments that are frivolous, insubstantial, or outside the scope of 
the direct final rule will not be considered significant or adverse 
under this procedure. For example, a comment recommending a regulation 
change in addition to the changes in the direct final rule would not be 
considered a significant adverse comment unless the comment states why 
the rule would be ineffective without the additional change. In 
addition, if a significant adverse comment applies to an amendment, 
paragraph, or section of this rule and that provision can be severed 
from the remainder of the rule, FDA may adopt as final the provisions 
of the rule that are not the subject of a significant adverse comment.
    If FDA does not receive any significant adverse comment in response 
to the direct final rule, the Agency will publish a document in the 
Federal Register confirming the effective date of the final rule. The 
Agency intends to make the direct final rule effective 30 days after 
publication of the confirmation document in the Federal Register.
    A full description of FDA's policy on direct final rule procedures 
may be found in a guidance for FDA and industry entitled ``Direct Final 
Rule Procedures'' (available on http://www.fda.gov/RegulatoryInformation/Guidances/ucm125166.htm) that was announced in 
the Federal Register of November 21, 1997 (62 FR 62466).

III. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the direct final 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 (Pub. L. 104-4). Executive Orders 12866 and 13563 direct us 
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). We have developed a comprehensive Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. We believe that 
this final rule is not a significant regulatory action as defined by 
Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. We certify that the direct final rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``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 $146 
million, using the most current (2015) Implicit Price Deflator for the 
Gross Domestic Product. This direct final rule would not result in an 
expenditure in any year that meets or exceeds this amount.

B. Need for the Regulation

    This rule is necessary to comply with the Montreal Protocol under 
authority of

[[Page 74301]]

Title VI of the Clean Air Act (section 601 et seq.), which banned the 
manufacture of ODSs, including CFCs, to reduce the depletion of the 
ozone layer in the United States as of January 1, 1996. EPA regulations 
exempted from the ban medical devices, diagnostic products, drugs, and 
drug delivery systems that FDA considered essential and that are listed 
in Sec.  2.125(e) when they use a class I or class II ODS for which no 
safe and effective alternative has been developed. The direct final 
rule would remove the exemptions for sterile aerosol talc products and 
for metered-dose atropine sulfate aerosol human drugs containing ODSs.
    There is currently at least one sterile aerosol talc product not 
containing ODSs approved for the administration intrapleurally by 
thoracoscopy for human use that is a safe and effective alternative, 
and which meets the criteria outlined in Sec.  2.125(g)(3). 
Accordingly, the sterile aerosol talc product containing ODSs no longer 
meets the requirements for an essential use and should no longer be 
exempted from the ban.
    Metered-dose atropine sulfate aerosol human drugs administered by 
oral inhalation are no longer available in the product market in an 
approved ODS formulation. The current absence of the product in the 
market indicates both a lack of demand for the product and that the 
product is nonessential, under Sec.  2.125(g)(1). With the adoption of 
this direct final rule, the manufacturer of the sterile aerosol talc 
with ODSs and any potential future manufacturers of metered-dose 
atropine sulfate aerosols will have notice of the requirements to 
comply with the ban of products from containing ODSs.

C. Benefits and Costs

1. Number of Affected Entities
    The affected entities covered by this direct final rule are the 
manufacturing facilities of the products that would have exemptions 
from the ban removed. Only one manufacturer, the Bryan Corporation that 
manufactures the sterile aerosol talc product containing ODSs at a 
single facility, would be affected. Currently, there are no 
manufacturers of metered-dose atropine sulfate aerosols.
2. Costs
    The potential social costs from removing the exemptions are (1) the 
costs to patient consumers or to their insurers for paying a higher 
price for alternative non-ODS formulations of sterile aerosol talc 
products and (2) the costs for disposing of and destroying any 
remaining product inventory that remains after the effective date of 
the direct final rule. We lack data about the remaining stocks of 
product inventory that are likely to remain after the effective date of 
the direct final rule and the relative price that consumers or their 
insurers would pay. Because significant notice has been given to the 
manufacturer about the impending removal of the exemptions, we do not 
believe a significant stock of inventory will remain for the sterile 
aerosol talc product. The most recent publically available information 
shows that the annual revenues for Bryan Corporation are about $10 
million (Ref. 1). Public information about this company shows that it 
manufactures three different surgical and medical instruments including 
the talc. If total profits for the exempt talc product are 10 percent 
of the total annual revenues, and if total revenues are exclusively 
from the exempt talc, then $1 million represents an upper bound for the 
total social cost of removing the sterile aerosol talc product from the 
market. Because it is unlikely that their total profits are exclusively 
from the sterile aerosol talc, it is more likely that the foregone 
profits are at most one-third of the $1 million; in fact, the true 
social cost could be significantly less than the total foregone profit 
of this product.
    Metered-dose atropine sulfate aerosol human drugs that would be 
affected by this rule are no longer marketed; consequently, removal of 
the exemption for this product would not present the public, consumers, 
insurers, or producers with any costs.
3. Health Benefits
    The direct final rule implements the requirements of the Clean Air 
Act that ban the use of products containing ODSs that no longer meet 
the requirements for essential use. The social benefits of the direct 
final rule derive from greater compliance with the Clean Air Act. The 
ODSs that either would have been emitted by sterile aerosol talcs that 
contain them, or from potential market entrants that would have 
manufactured metered-dose atropine sulfate aerosols that contain ODSs 
will no longer be emitting them, which will help reduce the depletion 
of the ozone layer and the ultraviolet radiation reaching the Earth. We 
lack the ability to quantify the health benefits from the reduced 
exposure to and from the reduced risk associated with ultraviolet light 
that result from removing the exemptions to the ban. Because the change 
in exposure and resulting risk from the final rule is likely to be 
small, the incremental health impact is likely to be too small to 
measure.

D. Economic Summary

    The direct final rule will remove the exemptions for sterile 
aerosol talc products and for metered-dose atropine sulfate aerosol 
human drugs containing ODSs. The primary public health benefit from 
adoption of the direct final rule is to reduce the depletion of the 
ozone layer to decrease human exposure to ultraviolet radiation. The 
reduction in exposure to ultraviolet radiation because of the direct 
rule is likely to be too small to measure. The potential social costs 
of the direct final rule would occur if patient consumers or their 
health care insurers would have to pay more for otherwise comparable 
products and if the product manufacturers would have to safely destroy 
any remaining product inventories after the effective date of the rule. 
We estimate that the social cost of the direct final rule is likely to 
be significantly less than $1 million but no more than the upper bound 
estimate of the foregone annual profit of the company that manufactures 
the sterile aerosol talc or $1 million. Because the metered-dose 
atropine sulfate aerosol is not currently in the market, there would be 
no social cost for removing its exemption from the ban.
    Imposing no new federal requirement is the baseline for a 
regulatory analysis. With no new regulation, there are no compliance 
costs or benefits to the direct final rule. However, because sterile 
aerosol talc is no longer an essential use of ODSs, under the Clean Air 
Act, there is no longer a pathway for sterile aerosol talc products 
containing ODSs to remain on the market.

IV. Final Regulatory Flexibility Analysis

    FDA has examined the economic implications of the direct final rule 
as required by the Regulatory Flexibility Act. If a rule will have a 
significant economic impact on a substantial number of small entities, 
the Regulatory Flexibility Act requires Agencies to analyze regulatory 
options that would lessen the economic effect of the rule on small 
entities. We certify that the direct final rule will not have a 
significant economic impact on a substantial number of small entities. 
This analysis, together with other relevant sections of this document, 
serves as the final regulatory flexibility analysis, as required under 
the Regulatory Flexibility Act.

[[Page 74302]]

V. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act of 1995

    FDA concludes that this direct final rule contains no collection of 
information. Therefore, clearance by the Office of Management and 
Budget under the Paperwork Reduction Act of 1995 is not required.

VII. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. We have determined that this final 
rule does not contain policies that have substantial direct effects on 
the States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

VIII. References

    The following reference is on display in the Division of Dockets 
Management (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at http://www.regulations.gov. FDA has 
verified the Web site address as of the date this document publishes in 
the Federal Register, but Web sites are subject to change over time.

1. Bryan Corporation (http://listings.findthecompany.com/l/12165972/Bryan-Corporation-in-Woburn-MA, accessed on February 24, 2016).

List of Subjects in 21 CFR Part 2

    Administrative practice and procedure, Cosmetics, Drugs, Foods.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
2 is amended as follows:

PART 2--GENERAL ADMINISTRATIVE RULINGS AND DECISIONS

0
1. The authority citation for part 2 continues to read as follows:

    Authority: 15 U.S.C. 402, 409; 21 U.S.C. 321, 331, 335, 342, 
343, 346a, 348, 351, 352, 355, 360b, 361, 362, 371, 372, 374; 42 
U.S.C. 7671 et seq.


Sec.  2.125   [Amended]

0
2. In Sec.  2.125, remove and reserve paragraphs (e)(4)(vi) and (ix).

    Dated: October 20, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-25851 Filed 10-25-16; 8:45 am]
 BILLING CODE 4164-01-P