Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Rules and Regulations 37815

times established in advance by a Notice to guidance for industry entitled Management Staff (HFA–305), Food and Airmen. The effective date and time will ‘‘Ultrafiltered Milk in the Production of Drug Administration, 5630 Fishers thereafter be continuously published in the Standardized Cheeses and Related Lane, Rm. 1061, Rockville, MD 20852. Pacific Chart Supplement. Cheese Products: Guidance for • For written/paper comments Paragraph 6004 Class E Airspace Areas Industry.’’ The guidance advises submitted to the Dockets Management Designated as an Extension to a Class D or manufacturers who wish to use Staff, FDA will post your comment, as Class E Surface Area. ultrafiltered milk (UF milk) or well as any attachments, except for * * * * * ultrafiltered nonfat milk (UF nonfat information submitted, marked and AWP HI E4 Hilo, HI [Corrected] milk) in the production of standardized identified, as confidential, if submitted cheeses and related cheese products as detailed in ‘‘Instructions.’’ Hilo International Airport, HI that, pending completion of a (Lat. 19°43′13″ N., long. 155°02′55″ W.) Instructions: All submissions received Hilo VORTAC rulemaking regarding the use of UF milk must include the Docket No. FDA– (Lat. 19°43′17″ N., long. 155°00′39″ W.) in the production of these products, we 2017–D–4713 for ‘‘Ultrafiltered Milk in That airspace extending upward from the intend to exercise enforcement the Production of Standardized Cheeses surface within 3 miles each side of the Hilo discretion regarding the use of fluid UF and Related Cheese Products: Guidance VORTAC 090° radial, extending from the 4.3- milk and fluid UF nonfat milk in the for Industry.’’ Received comments will mile radius of Hilo International Airport to production of standardized cheeses and be placed in the docket and, except for 8.7 miles east of the Hilo VORTAC. related cheese products. We also intend those submitted as ‘‘Confidential Paragraph 6005 Class E Airspace Extending to exercise enforcement discretion Submissions,’’ publicly viewable at Upward From 700 Feet or More Above the regarding the declaration of ingredients https://www.regulations.gov or at the Surface of the Earth. in the labeling of standardized cheeses Dockets Management Staff between 9 * * * * * and related cheese products when fluid a.m. and 4 p.m., Monday through UF milk and fluid UF nonfat milk are Friday. AWP HI E5 Hilo, HI [Amended] used as ingredients. • Confidential Submissions—To Hilo International Airport, HI DATES: The announcement of the ° ′ ″ ° ′ ″ submit a comment with confidential (Lat. 19 43 13 N., long. 155 02 55 W.) guidance is published in the Federal information that you do not wish to be Hilo VORTAC Register on August 14, 2017. Submit (Lat. 19°43′17″ N., long. 155°00′39″ W.) made publicly available, submit your either electronic or written comments comments only as a written/paper That airspace extending upward from 700 on FDA guidance at any time. feet above the surface within a 4.3-mile submission. You should submit two radius of Hilo International Airport and ADDRESSES: You may submit comments copies total. One copy will include the within 3 miles each side of the Hilo VORTAC as follows: information you claim to be confidential ° 090 radial, extending from the 4.3-mile Electronic Submissions with a heading or cover note that states radius to 8.7 miles east of the VORTAC and ‘‘THIS DOCUMENT CONTAINS that airspace extending from the 4.3-mile Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ We radius to the 7.4-mile radius of the Hilo following way: will review this copy, including the International Airport extending clockwise • Federal eRulemaking Portal: claimed confidential information, in our from a line 1.8 miles southwest of and https://www.regulations.gov. Follow the consideration of comments. The second parallel to the Hilo VORTAC 321° radial to instructions for submitting comments. copy, which will have the claimed a line 3 miles north of and parallel to the Comments submitted electronically, ° confidential information redacted/ Hilo VORTAC 090 radial. including attachments, to https:// blacked out, will be available for public Issued in Seattle, Washington, on August 3, www.regulations.gov will be posted to viewing and posted on https:// 2017. the docket unchanged. Because your www.regulations.gov. Submit both Byron Chew, comment will be made public, you are solely responsible for ensuring that your copies to the Dockets Management Staff. Acting Group Manager, Operations Support If you do not wish your name and Group, Western Service Center. comment does not include any confidential information that you or a contact information to be made publicly [FR Doc. 2017–17004 Filed 8–11–17; 8:45 am] available, you can provide this BILLING CODE 4910–13–P third party may not wish to be posted, such as medical information, your or information on the cover sheet and not anyone else’s Social Security number, or in the body of your comments and you confidential business information, such must identify this information as DEPARTMENT OF HEALTH AND ‘‘confidential.’’ Any information marked HUMAN SERVICES as a manufacturing process. Please note that if you include your name, contact as ‘‘confidential’’ will not be disclosed except in accordance with 21 CFR 10.20 Food and Drug Administration information, or other information that identifies you in the body of your and other applicable disclosure law. For more information about FDA’s posting 21 CFR Part 133 comments, that information will be posted on https://www.regulations.gov. of comments to public dockets, see 80 [Docket No. FDA–2017–D–4713] • If you want to submit a comment FR 56469, September 18, 2015, or access with confidential information that you the information at: https://www.gpo.gov/ Ultrafiltered Milk in the Production of fdsys/pkg/FR-2015-09-18/pdf/2015- Standardized Cheeses and Related do not wish to be made available to the public, submit the comment as a 23389.pdf. Cheese Products: Guidance for Docket: For access to the docket to Industry; Availability written/paper submission and in the manner detailed (see ‘‘Written/Paper read background documents or the AGENCY: Food and Drug Administration, Submissions’’ and ‘‘Instructions’’). electronic and written/paper comments HHS. received, go to https:// Written/Paper Submissions ACTION: Notification of availability. www.regulations.gov and insert the Submit written/paper submissions as docket number, found in brackets in the SUMMARY: The Food and Drug follows: heading of this document, into the Administration (FDA or we) is • Mail/Hand delivery/Courier (for ‘‘Search’’ box and follow the prompts announcing the availability of a written/paper submissions): Dockets and/or go to the Dockets Management

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Staff, 5630 Fishers Lane, Rm. 1061, ultrafiltration. For purposes of this organoleptic properties of the cheese or Rockville, MD 20852. guidance, we consider filtration to be a cheese product are not affected. FDA is Submit written requests for single process whereby milk is passed over a also announcing its intent to exercise copies of the guidance to the Office of series of semipermeable membranes enforcement discretion with respect to Nutrition and Food Labeling, Center for with varying pore sizes. Ultrafiltration the labeling of standardized cheeses and Food Safety and Applied Nutrition retains macromolecules and particles related cheese products, when, in (HFS–830), Food and Drug larger than about 0.001–0.02 addition to milk or nonfat milk, fluid Administration, 5001 Campus Dr., micrometers. In dairy processing, UF milk or fluid UF nonfat milk is used College Park, MD 20740. Send two self- ultrafiltration is typically used to retain as an ingredient, but is not declared in addressed adhesive labels to assist that all protein components of milk, the ingredient statement, provided that office in processing your request. See including casein and whey proteins, milk or nonfat milk is declared in the the SUPPLEMENTARY INFORMATION section while some of the lactose, minerals, and ingredient statement. We are exercising for electronic access to the guidance. water soluble vitamins present in milk enforcement discretion with respect to FOR FURTHER INFORMATION CONTACT: are lost along with water. the labeling of fluid UF milk and fluid Terri Wenger, Center for Food Safety For purposes of the guidance, UF milk UF nonfat milk in recognition of the and Applied Nutrition (HFS–800), Food means raw or pasteurized milk that is costs and logistics involved in label and Drug Administration, 5001 Campus passed over one or more semipermeable changes; however, we encourage Dr., College Park, MD 20740, 240–402– membranes to partially remove water, industry to identify these ingredients as 2373. lactose, minerals, and water-soluble ‘‘ultrafiltered milk’’ and ‘‘ultrafiltered vitamins without altering the nonfat milk’’ to the extent feasible and SUPPLEMENTARY INFORMATION: casein::whey protein ratio of the milk appropriate. We intend to exercise and resulting in a liquid product. UF I. Background enforcement discretion until we have nonfat milk is defined similarly, except We are announcing the availability of completed a rulemaking process that raw or pasteurized nonfat milk is a guidance for industry entitled amending our regulations with respect used. ‘‘Ultrafiltered Milk in the Production of In the Federal Register of October 19, to the issues covered by this guidance, Standardized Cheeses and Related 2005 (70 FR 60751), we issued a or announce in the Federal Register our Cheese Products: Guidance for proposed rule that would amend our determination not to proceed with such Industry.’’ We are issuing this guidance regulations to provide for the use of a rulemaking. consistent with our good guidance fluid UF milk in the manufacture of We are issuing this guidance without practices regulation (21 CFR 10.115). standardized cheeses and related cheese prior public comment under 21 CFR The guidance represents the current products. We tentatively concluded that 10.115(g)(2) because we have thinking of FDA on this topic. It does the proposed rule, if finalized, would determined that prior public not establish any rights for any person promote honesty and fair dealing in the participation is not feasible or and is not binding on FDA or the public. interest of consumers and, to the extent appropriate, as this guidance You can use an alternative approach if practicable, achieve consistency with implements a temporary enforcement it satisfies the requirements of the existing international standards of policy to address an oversupply of UF applicable statutes and regulations. identity for cheeses and related cheese pending the completion of rulemaking Our regulations specify the standards products. regarding the use of UF milk in the of identity for cheeses and related While we have not completed the production of standardized cheeses and cheese products in part 133 (21 CFR rulemaking as of August 2017, we are related cheese products. The oversupply part 133). The general provisions within aware of issues regarding UF milk in the of UF milk would be worsened if we part 133, in part, define ‘‘milk’’ and United States. In brief, due to recent deferred exercising of enforcement ‘‘nonfat milk’’ that may be used in the developments in the export market, the discretion regarding the matters in the manufacture of cheeses and related United States dairy industry is guidance while providing an cheese products. The definitions for experiencing an oversupply of and opportunity for prior public comment. ‘‘milk’’ and ‘‘nonfat milk’’ in § 133.3(a) pricing challenges with domestically (We also note that, as we stated in the and (b), respectively, list different forms produced UF milk (Refs. 1 and 2). preamble to the 2005 proposed rule, we of milk and nonfat milk, including Additionally, we have received requests tentatively conclude that fluid UF milk concentrated, reconstituted, and dried to exercise enforcement discretion while can be used in standardized cheeses forms, that may be used in the making the rulemaking is pending, in part to while maintaining the essential of cheeses and related cheese products. mitigate the impact on U.S. companies characteristics of those cheeses However, fluid or dried filtered forms of producing UF milk (Ref. 3). milk obtained through mechanical FDA believes that food standards specified in the individual standards of filtration of milk or nonfat milk are not should provide for flexibility in identity in part 133 (see 70 FR 60751 at included within these definitions. manufacturing procedures and 60756 through 60757).) However, as Therefore, while current regulations ingredients, provided that the basic with all Agency guidances, the public permit the use of concentrated, nature and essential characteristics of may comment on the guidance at any reconstituted, and dried forms of milk the food are preserved. Given the time. This guidance is not subject to and nonfat milk as basic dairy oversupply of UF milk and the pending Executive Order 12866. ingredients (i.e., the only difference in rulemaking, through this guidance we II. Electronic Access these ingredients is the amount of are announcing our intent to exercise water), they do not provide for the use enforcement discretion regarding the Persons with access to the internet of fluid or dried filtered milk or fluid or use of fluid UF milk and fluid UF nonfat may obtain the guidance at either dried filtered nonfat milk as basic dairy milk in the production of standardized https://www.fda.gov/FoodGuidances or ingredients in standardized cheeses and cheeses and related cheese products https://www.regulations.gov. Use the related cheese products. under part 133, in addition to the other FDA Web site listed in the previous Mechanical filtration technologies required dairy ingredients, provided sentence to find the most current available for milk processing include that the physical, chemical, and version of the guidance.

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III. References section 148 of the Internal Revenue ACTION: Final rule. The following references are on Code applicable to tax-exempt bonds display in the Dockets Management and other tax-advantaged bonds issued SUMMARY: The Environmental Protection by State and local governments. Staff (see ADDRESSES) and are available Agency (EPA) is taking final action to for viewing by interested persons DATES: This correction is effective approve a revision to the San Joaquin between 9 a.m. and 4 p.m., Monday August 14, 2017 and applicable July 18, Valley Unified Air Pollution Control through Friday; they are also available 2016. District (SJVUAPCD or ‘‘the District’’) electronically at https:// FOR FURTHER INFORMATION CONTACT: portion of the California State www.regulations.gov. FDA has verified Spence Hanemann at (202) 317–6980 Implementation Plan (SIP). This revised the Web site addresses, as of the date (not a toll-free number). rule concerns emissions of oxides of this document publishes in the Federal SUPPLEMENTARY INFORMATION: nitrogen, carbon monoxide, oxides of Register, but Web sites are subject to Background sulfur, and particulate matter of 10 change over time. microns or less from boilers, steam The final regulations (TD 9777) that 1. Letter from Senator Amy Klobuchar, generators and process heaters. We are are the subject of this correction are Senator Al Franken, Representative approving a local rule that regulates Collin Peterson, and Representative Tim under section 148 of the Internal Walz, to President Donald J. Trump, Revenue Code. these emission sources under the Clean accessed on the Web at https:// Air Act (CAA or the Act). www.klobuchar.senate.gov/public/ Need for Correction DATES: This rule will be effective on index.cfm/2017/4/klobuchar-franken- As published, the final regulations September 13, 2017. peterson-walz-urge-administration-to- (TD 9777) contain an error that may support-minnesota-dairy-farmers- prove to be misleading and are in need ADDRESSES: The EPA has established a through-strong-enforcement-of-our-trade- of clarification. docket for this action under Docket ID laws-with-canada. No. EPA–R09–OAR–2017–0034. All 2. Congressional Research Service, ‘‘New List of Subjects in 26 CFR Part 1 Canadian Dairy Pricing Regime Proves documents in the docket are listed on Disruptive for U.S. Milk Producers,’’ Income taxes, Reporting and the http://www.regulations.gov Web dated April 20, 2017, accessed on the recordkeeping requirements. site. Although listed in the index, some Web at https://www.everycrsreport.com/ Correction of Publication information is not publicly available, reports/IN10692.html. e.g., Confidential Business Information 3. Letter from Michael D. Dykes, D.V.M., Accordingly, 26 CFR part 1 is President and CEO, International Dairy amended by making the following or other information whose disclosure is Foods Association, to Stephen Ostroff, correcting amendment: restricted by statute. Certain other M.D., Deputy Commissioner for Foods material, such as copyrighted material, and Veterinary Medicine, Food and Drug PART 1—INCOME TAXES is not placed on the Internet and will be Administration, dated June 22, 2017. publicly available only in hard copy ■ Paragraph 1. The authority citation Dated: August 9, 2017. form. Publicly available docket for part 1 continues to read in part as materials are available through http:// Anna K. Abram, follows: Deputy Commissioner for Policy, Planning, www.regulations.gov, or please contact Legislation, and Analysis. Authority: 26 U.S.C. 7805 * * * the person identified in the FOR FURTHER [FR Doc. 2017–17118 Filed 8–11–17; 8:45 am] § 1.148–11 [Amended] INFORMATION CONTACT section for additional availability information. BILLING CODE 4164–01–P ■ Par. 2. Amend § 1.148–11(k)(1) by adding ‘‘1.148–6(d)(3)(iii)(A);’’ before FOR FURTHER INFORMATION CONTACT: ‘‘1.148–6(d)(4)’’. Nancy Levin, EPA Region IX, (415) 972– DEPARTMENT OF THE TREASURY 3848, [email protected]. Martin V. Franks, Internal Revenue Service Chief, Publications and Regulations Branch, SUPPLEMENTARY INFORMATION: Legal Processing Division, Associate Chief Throughout this document, ‘‘we,’’ ‘‘us’’ 26 CFR Part 1 Counsel (Procedure and Administration) . and ‘‘our’’ refer to the EPA. [FR Doc. 2017–17135 Filed 8–11–17; 8:45 am] [TD 9777] BILLING CODE 4830–01–P Table of Contents RIN 1545–BG41; 1545–BH38 I. Proposed Action II. Public Comments and EPA Responses Arbitrage Guidance for Tax-Exempt ENVIRONMENTAL PROTECTION III. EPA Action Bonds; Correction AGENCY IV. Incorporation by Reference V. Statutory and Executive Order Reviews AGENCY: Internal Revenue Service (IRS), 40 CFR Part 52 Treasury. I. Proposed Action [EPA–R09–OAR–2017–0034; FRL–9965–26– ACTION: Correcting amendment. Region 9] On March 21, 2017 (82 FR 14496), the SUMMARY: EPA proposed to approve the following This document contains a Approval of California Air Plan correction to final regulations (TD 9777) Revisions, San Joaquin Valley Unified rule into the California SIP. that were published in the Federal Air Pollution Control District Register on Monday, July 18, 2016 (81 FR 46582). The final regulations relate AGENCY: Environmental Protection to the arbitrage restrictions under Agency (EPA).

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