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Federal Register/Vol. 82, No. 155/Monday, August 14, 2017 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 VerDate Sep<11>2014 15:51 Aug 11, 2017 Jkt 241001 PO 00000 Frm 00011 Fmt 4700 Sfmt 4700 E:\FR\FM\14AUR1.SGM 14AUR1 sradovich on DSK3GMQ082PROD with RULES 37816 Federal Register / Vol. 82, No. 155 / Monday, August 14, 2017 / Rules and Regulations 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.
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