Federal Register/Vol. 84, No. 226/Friday, November 22, 2019

Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices 64541 Based on Agency data, we have 163.123, 163.124, 163.130, 163.135, Dated: November 18, 2019. received no more than 50 submissions 163.140, and 163.145). Lowell J. Schiller, since establishing the collection in For the purpose of this permit, ‘‘ruby Principal Associate Commissioner for Policy. 2017. chocolate’’ is the solid or semiplastic [FR Doc. 2019–25325 Filed 11–21–19; 8:45 am] Dated: November 18, 2019. food prepared by mixing and grinding BILLING CODE 4164–01–P Lowell J. Schiller, cacao fat with one or more of the cacao Principal Associate Commissioner for Policy. ingredients (namely, chocolate liquor, [FR Doc. 2019–25364 Filed 11–21–19; 8:45 am] breakfast cocoa, cocoa, and lowfat DEPARTMENT OF HEALTH AND cocoa), citric acid, one or more of BILLING CODE 4164–01–P HUMAN SERVICES optional dairy ingredients, and one or more optional nutritive carbohydrate Food and Drug Administration DEPARTMENT OF HEALTH AND sweeteners. ‘‘Ruby chocolate’’ contains HUMAN SERVICES not less than 1.5 percent nonfat cacao [Docket No. FDA–2010–D–0319] solids, not less than 20 percent by Food and Drug Administration weight of cacao fat, not less than 2.5 Agency Information Collection percent by weight of milk fat, not less Activities; Submission for Office of [Docket No. FDA–2019–N–4844] than 12 percent by weight of total milk Management and Budget Review; solids, not more than 1.5 percent of ‘‘Ruby Chocolate’’ Deviating From Comment Request; Dear Health Care emulsifying agents, and not more than Identity Standard; Temporary Permit Provider Letters: Improving 5 percent of whey or whey products. It for Market Testing Communication of Important Safety may also contain other ingredients such Information AGENCY: Food and Drug Administration, as antioxidants approved for food use, HHS. spices, natural and artificial flavorings, AGENCY: Food and Drug Administration, ACTION: Notice. and other seasonings. However, these HHS. other ingredients cannot imitate the SUMMARY: The Food and Drug flavor of chocolate, milk or butter, berry ACTION: Notice. Administration (FDA or we) is or another fruit. Additionally, ‘‘ruby announcing that a temporary permit has chocolate’’ contains no added coloring. SUMMARY: The Food and Drug been issued to Barry Callebaut U.S.A. The test product ‘‘ruby chocolate’’ Administration (FDA, the Agency, or LLC (the applicant) to market test a contains the principal ingredients used we) is announcing that a proposed product identified as ‘‘ruby chocolate’’ in most of the current standards for collection of information has been that deviates from the U.S. standards of cacao products under 21 CFR part 163; submitted to the Office of Management identity for chocolate products. The however, it deviates from the current and Budget (OMB) for review and temporary permit will allow the standards of identity for chocolate clearance under the Paperwork applicant to evaluate commercial products in terms of its final Reduction Act of 1995. viability of the product and to collect composition, taste, and color. DATES: Fax written comments on the data on consumer acceptance of the The purpose of the temporary permit product. is to allow the applicant to market test collection of information by December 23, 2019. DATES: This permit is effective for 15 the product throughout the United months, beginning on the date the States. The permit will allow the ADDRESSES: To ensure that comments on applicant introduces or causes applicant to evaluate commercial the information collection are received, introduction of the test product into viability of the product and to collect OMB recommends that written interstate commerce, but not later than data on consumer acceptance of the comments be faxed to the Office of February 20, 2020. product. Information and Regulatory Affairs, FOR FURTHER INFORMATION CONTACT: The permit provides for the temporary OMB, Attn: FDA Desk Officer, Fax: 202– Marjan Morravej, Center for Food Safety marketing of approximately 60 million 395–7285, or emailed to oira_ and Applied Nutrition (HFS–820), Food pounds (27,215,540 kilograms) of the [email protected]. All and Drug Administration, 5001 Campus test product. The test product will be comments should be identified with the Dr., College Park, MD 20740, 240–402– manufactured at the Barry Callebaut OMB control number 0910–0754. Also 2371. facilities located at Aalstersestraat 122, include the FDA docket number found SUPPLEMENTARY INFORMATION: We are 9280 Lebbeke, Belgium; 400 Industrial in brackets in the heading of this giving notice that we have issued a Park Rd., St. Albans, VT 05478; and document. temporary permit to Barry Callebaut 1175 Commerce Blvd., American U.S.A. LLC. We are issuing the Canyon, CA 94503. FOR FURTHER INFORMATION CONTACT: temporary permit in accordance with 21 Barry Callebaut U.S.A. LLC will Domini Bean, Office of Operations, CFR 130.17, which addresses temporary distribute the test product to various Food and Drug Administration, Three permits for interstate shipment of manufacturers throughout the United White Flint North, 10A–12M, 11601 experimental packs of food varying from States for further manufacturing and Landsdown St., North Bethesda, MD the requirements of definitions and market testing. Each ingredient used in 20852, 301–796–5733, PRAStaff@ standards of identity issued under the food must be declared on the label fda.hhs.gov. section 401 of the Federal Food, Drug, as required by 21 CFR part 101. The and Cosmetic Act (21 U.S.C. 341). permit is effective for 15 months, SUPPLEMENTARY INFORMATION: In The permit covers the interstate beginning on the date the applicant compliance with 44 U.S.C. 3507, FDA market testing of the product identified introduces or causes the introduction of has submitted the following proposed as ‘‘ruby chocolate.’’ The test product the test product into interstate collection of information to OMB for deviates from the U.S. standards of commerce, but not later than February review and clearance. identity for chocolates (21 CFR 163.111, 20, 2020. VerDate Sep<11>2014 16:57 Nov 21, 2019 Jkt 250001 PO 00000 Frm 00089 Fmt 4703 Sfmt 4703 E:\FR\FM\22NON1.SGM 22NON1 khammond on DSKJM1Z7X2PROD with NOTICES 64542 Federal Register / Vol. 84, No. 226 / Friday, November 22, 2019 / Notices Agency Information Collection at: https://www.fda.gov/media/79793/ Document Archiving, Reporting, and Activities; Proposed Collection; download. Regulatory Tracking System for 2016— Comment Request; Guidance for The guidance document gives specific 2018, we identified 38 DHCP letters that Industry on Dear Health Care Provider instruction on what should and should were sent by 24 distinct sponsors during Letters: Improving Communication of not be included in DHCP letters. Some the 3-year timeframe. We estimate that Important Safety Information DHCP letters have been too long, have we will receive approximately 13 DHCP contained promotional material, or letters annually from approximately 8 OMB Control Number 0910–0754— otherwise have not met the goals set application holders. FDA professionals Extension forth in the applicable regulation (21 familiar with DHCP letters, and with the This information collection supports CFR 200.5). In some cases, health care recommendations in the guidance, recommendations found in the Agency providers have not been aware of estimate that it should take an guidance document entitled ‘‘Dear important new information, and have application holder approximately 100 Health Care Provider Letters: Improving been unable to communicate it to hours to prepare and send DHCP letters Communication of Important Safety patients, because the letters’ content and in accordance with the guidance. Information.’’ The guidance provides length have made it difficult to find the In the Federal Register of August 19, instruction to industry and FDA staff on relevant information. In addition, letters 2019 (84 FR 42929), we published a 60- the content and format of Dear Health have sometimes been sent for the wrong day notice requesting public comment Care Provider (DHCP) letters. These reasons. on the proposed collection of letters are sent by manufacturers or In addition to content and format information. One comment was received distributors to health care providers to recommendations for each type of DHCP expressing the importance of communicate an important drug letter, the guidance also includes communicating safety information, for warning, a change in prescribing recommendations on consulting with which we are appreciative. No other information, or a correction of FDA on how to develop a DHCP letter, comments were received. misinformation in prescription drug when to send a letter, what type of letter We estimate the annual reporting promotional labeling or advertising. The to send, and how to assess the letter’s burden of this collection of information guidance is available from our website impact. Based on a review of FDA’s as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of Average Type of activity Number of responses per Total annual burden per Total hours respondents respondent responses response Dear Health Care Provider Letters ...................................... 8 1.625 13 100 1,300 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on a review of the information confidential trade secrets or commercial Dated: November 15, 2019. collection, we have reduced our burden property such as patentable material, Tyeshia M. Roberson, estimate by 17 respondents with a and personal information concerning Program Analyst, Office of Federal Advisory corresponding decrease in annual hours individuals associated with the grant Committee Policy. by 1,200. We attribute the decrease to applications, the disclosure of which [FR Doc. 2019–25306 Filed 11–21–19; 8:45 am] the effectiveness of the guidance. would constitute a clearly unwarranted BILLING CODE 4140–01–P Dated: November 14, 2019. invasion of personal privacy. Lowell J. Schiller, Name of Committee: National Institute of DEPARTMENT OF HEALTH AND Principal Associate Commissioner for Policy.

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