Federal Register/Vol. 85, No. 202/Monday, October 19, 2020

66338 Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Notices ‘‘Total Sugars’’ declaration, we could (kcal/g)) + (amount of other sugar would be scientifically appropriate for exclude them from the ‘‘Total Sugars’’ (g/serving) × caloric value (kcal/g)) such a category? Please provide any data declaration, or we could adjust the gram a. Sucrose: 5 g/serving × 4 kcal/g or other information that supports your amount of the ‘‘Total Sugars’’ (caloric value of sucrose) = 20 kcal/ recommendation. declaration based on their caloric serving Dated: October 9, 2020. b. Other sugar: 10 g/serving × 2 kcal/ contribution to the diet. What Lauren K. Roth, considerations could inform our g (caloric value of other sugar) = 20 kcal/serving Acting Principal Associate Commissioner for approach? Please explain your Policy. reasoning, and provide data or other c. Total Caloric Contribution = 20 [FR Doc. 2020–22900 Filed 10–16–20; 8:45 am] information that would support these kcal/serving (sucrose) + 20 kcal/ BILLING CODE 4164–01–P considerations and any recommended serving (other sugar) = 40 kcal/ approach. serving 2. In the guidance regarding allulose, Step 2. Calculate Total Amount of Sugars Adjusted for the Total DEPARTMENT OF HEALTH AND we discuss factors that we considered HUMAN SERVICES when determining whether a sugar Caloric Contribution (Total Caloric should be excluded from the declaration Contribution of Sugars (kcal/ ÷ Health Resources and Services of ‘‘Total Sugars,’’ including pH of serving) 4 kcal/g)) Administration dental plaque after consumption, caloric Amount of Sugars Adjusted for Caloric Contribution = 40 kcal/ National Vaccine Injury Compensation value, and glycemic and insulinemic ÷ response. What, if any, other factors serving 4 kcal/g = 10 g-equivalent/ Program; List of Petitions Received serving impact whether a sugar should be AGENCY: Health Resources and Services excluded from the declaration of ‘‘Total Step 3. Calculate %DV for Added Sugars (Amount of Sugars Adjusted Administration (HRSA), Department of Sugars’’? Please provide any data or Health and Human Services (HHS). other information that supports your for Caloric Contribution (g- ÷ ACTION: Notice. response. equivalent) 50 g/day (DV for Added Sugars for the general U.S. SUMMARY: C. Declaration of Added Sugars population 4 years of age and older) HRSA is publishing this notice of petitions received under the × 100)) 1. We could take one of various ÷ × National Vaccine Injury Compensation approaches to account for sugars that %DV = (10 g-equivalent 50 g/day) 100 = 20% Program (the Program), as required by are metabolized differently than the Public Health Service (PHS) Act, as What considerations are there with traditional sugars in the declaration of amended. While the Secretary of HHS is respect to adjusting the %DV ‘‘Added Sugars.’’ For example, we could named as the respondent in all require them to be declared within the declaration based on the caloric proceedings brought by the filing of ‘‘Added Sugars’’ declaration, we could contribution of the sugar? petitions for compensation under the exclude them from the ‘‘Added Sugars’’ D. Label Declarations Program, the United States Court of declaration, or we could adjust the gram Federal Claims is charged by statute amount of the ‘‘Added Sugars’’ or the 1. We currently require the disclosure of sugar alcohols and sugars that are with responsibility for considering and %DV declaration based on their caloric acting upon the petitions. contribution to the diet. What metabolized differently than traditional sugars in the ingredient statement in FOR FURTHER INFORMATION CONTACT: For considerations could inform our information about requirements for approach? Please explain your accordance with § 101.4(a), but also allow for the voluntary declaration of filing petitions, and the Program in reasoning, and provide data or other general, contact Lisa L. Reyes, Clerk of information that would support these sugar alcohols on the Nutrition Facts label (§ 101.9(c)(6)(iv)). Please provide Court, United States Court of Federal considerations and any recommended Claims, 717 Madison Place NW, approach. any data or other information that we could consider when determining Washington, DC 20005, (202) 357–6400. 2. In the guidance regarding allulose, For information on HRSA’s role in the we discuss factors that we considered whether we should allow for the voluntary declaration on the Nutrition Program, contact the Director, National when determining whether a sugar Vaccine Injury Compensation Program, should be excluded from the declaration Facts label of sugars that are metabolized differently than traditional 5600 Fishers Lane, Room 08N146B, of ‘‘Added Sugars,’’ including caloric Rockville, Maryland 20857; (301) 443– value and glycemic and insulinemic sugars. 2. Sugar alcohols fall into a separate 6593, or visit our website at: http:// response. What other factors, if any, category of labeling and are excluded www.hrsa.gov/vaccinecompensation/ impact whether a sugar should be from the ‘‘Total Sugars’’ and ‘‘Added index.html. excluded from the declaration of Sugars’’ declarations. Please provide SUPPLEMENTARY INFORMATION: The ‘‘Added Sugars’’? Please provide any any data or other information that we Program provides a system of no-fault data or other information that supports could consider when determining compensation for certain individuals your response. who have been injured by specified 3. We might adjust the %DV for whether sugars that are metabolized childhood vaccines. Subtitle 2 of Title ‘‘Added Sugars’’ for the U.S. population differently than traditional sugars XXI of the PHS Act, 42 U.S.C. 300aa– 4 years of age and older based on the should be combined with sugar alcohols 10 et seq., provides that those seeking caloric contribution of the sugar. For into one declaration within the compensation are to file a petition with example: Nutrition Facts label. 3. If sugars that are metabolized the United States Court of Federal Assume a product contains 5 g of differently than traditional sugars are Claims and to serve a copy of the sucrose and 10 g of another sugar with excluded from the ‘‘Total Sugars’’ and petition to the Secretary of HHS, who is a caloric value of 2 kcal/g per serving. ‘‘Added Sugars’’ declarations and are named as the respondent in each Step 1. Calculate the Total Caloric combined with sugar alcohols in a proceeding. The Secretary has delegated Contribution of Sugars (amount of separate labeling category within the this responsibility under the Program to sucrose (g/serving) × caloric value Nutrition Facts label, what names HRSA. The Court is directed by statute VerDate Sep<11>2014 18:05 Oct 16, 2020 Jkt 253001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 E:\FR\FM\19OCN1.SGM 19OCN1 jbell on DSKJLSW7X2PROD with NOTICES Federal Register / Vol. 85, No. 202 / Monday, October 19, 2020 / Notices 66339 to appoint special masters who take the Table but which was caused by a Federal Claims No: 20–1137V evidence, conduct hearings as vaccine’’ referred to in the Table. 21. Isabel Irizarry, Brooklyn, New York, appropriate, and make initial decisions In accordance with Section Court of Federal Claims No: 20–1140V as to eligibility for, and amount of, 2112(b)(2), all interested persons may 22. Elizabeth Merwitz, Montgomery, Texas, submit written information relevant to Court of Federal Claims No: 20–1141V compensation. 23. Pamela Vitrano, New Orleans, Louisiana, A petition may be filed with respect the issues described above in the case of Court of Federal Claims No: 20–1142V to injuries, disabilities, illnesses, the petitions listed below. Any person 24. Sara Storm and Joshua Storm on behalf conditions, and deaths resulting from choosing to do so should file an original of K.A.S., Madison, Wisconsin, Court of vaccines described in the Vaccine Injury and three (3) copies of the information Federal Claims No: 20–1143V Table (the Table) set forth at 42 CFR with the Clerk of the United States 25. Kathryn Frowein, Hartford, Wisconsin, 100.3. This Table lists for each covered Court of Federal Claims at the address Court of Federal Claims No: 20–1146V childhood vaccine the conditions that listed above (under the heading FOR 26. Frederick Reno, Santa Rosa, California, Court of Federal Claims No: 20–1147V FURTHER INFORMATION CONTACT), with a may lead to compensation and, for each 27. Brett Van Leer-Greenberg on behalf of condition, the time period for copy to HRSA addressed to Director, H. V.L., New York, New York, Court of occurrence of the first symptom or Division of Injury Compensation Federal Claims No: 20–1150V manifestation of onset or of significant Programs, Healthcare Systems Bureau, 28. Sarah Hall, Lakeland, Florida, Court of aggravation after vaccine 5600 Fishers Lane, 08N146B, Rockville, Federal Claims No: 20–1151V administration. Compensation may also Maryland 20857. The Court’s caption 29. Sidney Lenox, Wichita, Kansas, Court of be awarded for conditions not listed in (Petitioner’s Name v. Secretary of HHS) Federal Claims No: 20–1152V the Table and for conditions that are and the docket number assigned to the 30. Debbie Fresch, Fort Worth, Texas, Court petition should be used as the caption of Federal Claims No: 20–1153V manifested outside the time periods 31. Bernard Neuwirth on behalf of The Estate specified in the Table, but only if the for the written submission. Chapter 35 of Ellen C. Neuwirth, Pittsburgh, petitioner shows that the condition was of title 44, United States Code, related Pennsylvania, Court of Federal Claims caused by one of the listed vaccines. to paperwork reduction, does not apply No: 20–1155V Section 2112(b)(2) of the PHS Act, 42 to information required for purposes of 32. Ronald Malinski, Sterling Heights, U.S.C. 300aa–12(b)(2), requires that carrying out the Program. Michigan, Court of Federal Claims No: 20–1156V ‘‘[w]ithin 30 days after the Secretary Thomas J. Engels, receives service of any petition filed 33.

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