Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Guidance for Industry; Availability, 57156-57159 [2021-22453]

Download as PDF 57156 Federal Register / Vol. 86, No. 196 / Thursday, October 14, 2021 / Notices For devices that: (1) Must bear UDIs on their labels and (2) are intended to be used more than once and reprocessed between uses, 21 CFR 801.45 requires the devices to be directly marked with a UDI. Compliance dates for these labeling, GUDID data submission, standard date format, and direct marking requirements can be found in the preamble to the UDI Rule (78 FR 58786 at 58815 to 58816). For more information about UDI compliance dates, please see the UDI web page, available at: https://www.fda.gov/ medical-devices/unique-deviceidentification-system-udi-system/ compliance-dates-udi-requirements. For labelers of class I devices, FDA has developed this draft guidance to revise section III. ‘‘Policy On Standard Date Formatting, UDI Labeling, and GUDID Submission Requirements for Class I and Unclassified Devices’’ of the guidance entitled ‘‘Unique Device Identification: Policy Regarding Compliance Dates for Class I and Unclassified Devices and Certain Devices Requiring Direct Marking’’ (‘‘2020 UDI Compliance Policy Guidance’’, available at: https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents/ unique-device-identification-policyregarding-compliance-dates-class-i-andunclassified-devices-and), which was issued on July 1, 2020. When this draft determining whether regulations on this subject should be amended in the future. This draft guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements for Certain Devices; Draft Guidance for Industry and Food and Drug Administration Staff’’. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. II. Paperwork Reduction Act of 1995 While this guidance contains no new collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in the following FDA regulations have been approved by OMB as listed in the following table: OMB control No. 21 CFR part Topic 801 subpart B and 830 ............................................................... 800, 801, and 809 ...................................................................... Unique Device Identification ....................................................... Medical Device Labeling Regulations ........................................ III. Electronic Access lotter on DSK11XQN23PROD with NOTICES1 guidance is finalized, the updates in section III of this draft guidance would supersede the recommendations in section III of the 2020 UDI Compliance Policy Guidance. FDA considered comments received on the guidance that appeared in the Federal Register on July 1, 2020 (85 FR 39477) as the Agency revised the guidance. This draft guidance explains that there are certain class I devices for which FDA does not intend to enforce GUDID submission requirements under § 830.300 and describes how a labeler of a class I device can determine if its device is considered a consumer health product. FDA has determined that the entry of UDI data into GUDID for these devices is burdensome to stakeholders. After undertaking a public health impact analysis, the Center for Devices and Radiological Health has a better understanding of the devices and device characteristics for which GUDID information is particularly useful in evaluating and improving device safety throughout a product life cycle, as well as the ones for which GUDID information may be less important in this regard. The policy proposed in this draft guidance is based on this analysis. We are proposing this change in policy through guidance to allow FDA and stakeholders an opportunity to fully assess its impact on public health. FDA will take the assessment into account in Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/medical-devices/ device-advice-comprehensiveregulatory-assistance/guidancedocuments-medical-devices-andradiation-emitting-products. This guidance document is also available at https://www.regulations.gov, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.fda.gov/vaccines-bloodbiologics/guidance-complianceregulatory-information-biologics. Persons unable to download an electronic copy of ‘‘Select Updates for Unique Device Identification: Policy Regarding Global Unique Device Identification Database Requirements VerDate Sep<11>2014 17:44 Oct 13, 2021 Jkt 256001 for Certain Devices; Draft Guidance for Industry and Food and Drug Administration Staff’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 17029 and complete title to identify the guidance you are requesting. Dated: October 7, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–22308 Filed 10–13–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 0910–0720 0910–0485 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2014–D–0055] Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods; Guidance for Industry; Availability Food and Drug Administration, Department of Health and Human Services (HHS). ACTION: Notice of availability. AGENCY: The Food and Drug Administration (FDA or we) is announcing the availability of a final guidance for industry entitled ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in SUMMARY: Frm 00034 Fmt 4703 Sfmt 4703 E:\FR\FM\14OCN1.SGM 14OCN1 Federal Register / Vol. 86, No. 196 / Thursday, October 14, 2021 / Notices Commercially Processed, Packaged, and Prepared Foods.’’ The guidance describes our views on voluntary shortterm (2.5-year) goals for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or prepared. These goals are intended to address the excessive intake of sodium in the current population and promote improvements in public health. DATES: The announcement of the guidance is published in the Federal Register on October 14, 2021. ADDRESSES: You may submit either electronic or written comments on FDA guidances at any time as follows: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 https://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’’). lotter on DSK11XQN23PROD with NOTICES1 Written/Paper Submissions Submit written/paper submissions as follows: • Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Dockets Management Staff, 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– 2014–D–0055 for ‘‘Voluntary Sodium VerDate Sep<11>2014 17:44 Oct 13, 2021 Jkt 256001 Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.’’ Received comments will be placed in the docket and, except for those submitted as ’’Confidential Submissions,’’ publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500. • 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.’’ We will review this copy, including the claimed confidential information, in our consideration of comments. The second copy, which will have the claimed confidential information redacted/ blacked out, will be available for public viewing and posted on https:// www.regulations.gov. Submit both copies to the Dockets Management Staff. 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: https:// www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf. Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https:// 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 Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240–402–7500. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of the guidance to the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (HFS– 255), Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740. Send two self-addressed PO 00000 Frm 00035 Fmt 4703 Sfmt 4703 57157 adhesive labels to assist that office in processing your request. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance. FOR FURTHER INFORMATION CONTACT: Kasey Heintz, Center for Food Safety and Applied Nutrition, Office of Food Additive Safety, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–1376; or Deirdre Jurand, Center for Food Safety and Applied Nutrition, Office of Regulations and Policy, Food and Drug Administration, 5001 Campus Dr., College Park, MD 20740, 240–402–2378. SUPPLEMENTARY INFORMATION: I. Background We are announcing the availability of a guidance for industry entitled ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.’’ We are issuing this guidance consistent with our good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. In the Federal Register of June 2, 2016 (81 FR 35363), we made available a draft guidance for industry entitled ‘‘Voluntary Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium in Commercially Processed, Packaged, and Prepared Foods.’’ The draft guidance described our tentative views on voluntary short-term and long-term goals for sodium reduction in a variety of identified categories of foods that are commercially processed, packaged, or prepared. Section IV of the Federal Register notice, ‘‘Issues for Consideration,’’ listed eight specific questions (or ‘‘issues’’) (81 FR 35363 at 35366). The comment period for issues related primarily to short-term goals (Issues 1 through 4) was scheduled to close on August 31, 2016, and the comment period for issues related primarily to long-term goals (Issues 5 through 8) was scheduled to close on October 31, 2016. In the Federal Register of August 30, 2017 (81 FR 59640), we published a notice extending the comment period for Issues 1 through 4 until October 17, 2016, and for Issues 5 through 8 until December 2, 2016. We received approximately 200 comments on the draft guidance. The comments generally recognized and E:\FR\FM\14OCN1.SGM 14OCN1 lotter on DSK11XQN23PROD with NOTICES1 57158 Federal Register / Vol. 86, No. 196 / Thursday, October 14, 2021 / Notices supported the benefit of sodium reduction efforts for public health. Many comments discussed the categories proposed in the draft guidance, including requests for greater clarity on our approach to establishing categories and suggestions for how certain categories should be changed. The comments also discussed sodium reduction efforts generally, including examples of successful sodium reduction across product categories or portfolios, examples of sodium reduction technologies, and examples of successful sodium reduction initiatives in other countries and jurisdictions. Some comments emphasized the barriers to sodium reduction, such as the time and cost associated with product reformulation, the standards of identity limitations for certain foods, and consumer preferences for certain kinds of ingredients. Several comments also requested more time to achieve the targets. Other general comments discussed the role of sodium in foods, recommended that we establish a monitoring plan, and recommended that we establish a comprehensive, national consumer education campaign for sodium reduction. After careful review of the comments, we have modified the guidance to clarify the voluntary sodium targets, timeframe, product categories, and descriptions. The guidance is intended to support an average sodium intake reduction to 3,000 milligrams/day. In addition, we have extended the milestone date for the short-term goals from 2 years to 2.5 years from the publication of the final guidance. The 2.5-year goals are intended to balance the need for broad and gradual reductions in sodium and what is publicly known about technical and market constraints on sodium reduction and reformulation. We are not finalizing the long-term (10-year) sodium reduction targets discussed in the draft guidance at this time. We revised the layout as well as category names and descriptions of the sodium guidance target table to improve understanding and provide additional clarity as to how foods should be categorized, and made changes to categories where they were supported by scientific data (e.g., we merged the ‘‘Ready-to-Eat Cereal, Flakes’’ category with the ‘‘Ready-to-Eat Cereal, Puffed’’ category and moved Provolone cheese from the ‘‘Monterey Jack and Other Semi-Soft Cheese’’ category to the ‘‘Pasta Filata Cheese (soft)’’ category). We also made technical corrections and editorial changes throughout the guidance to VerDate Sep<11>2014 17:44 Oct 13, 2021 Jkt 256001 improve clarity, and included more recent data in our references. The guidance announced in this notice finalizes the draft guidance with respect to the short-term sodium reduction goals. II. Paperwork Reduction Act of 1995 While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501– 3521) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in 21 CFR part 101 have been approved under OMB control number 0910–0381. The collections of information in 21 CFR 101.11 have been approved under OMB control number 0910–0782. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/FoodGuidances, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous sentence to find the most current version of the guidance. IV. References The following references marked with an asterisk (*) are on display at the Dockets Management Staff (see ADDRESSES) and are available for viewing by interested persons between 9 a.m. and 4 p.m., Monday through Friday; they also are available electronically at https:// www.regulations.gov. References without asterisks are not on public display at https://www.regulations.gov because they have copyright restriction or are not publications. Some may be available at the website address, if listed. References without asterisks are available for viewing only at the Dockets Management Staff or, in the case of nonpublication references, at any website listed. FDA has verified the website addresses, as of the date this document publishes in the Federal Register, but websites are subject to change over time. 1. Mattes RD and Donnelly D., ‘‘Relative contributions of dietary sodium sources.’’ Journal of the American College of Nutrition, 10(4) (Aug. 1991): pp. 383–393. 2. Harnack LJ, Cogswell ME, Shikany JM, Gardner CD, Gillespie C, Loria CM, Zhou X, Yuan K, Steffen LM., ‘‘Sources of Sodium in US Adults From 3 Geographic Regions.’’ Circulation, 135 (May 9, 2017): pp. 1775– 1783. PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 3. U.S. Department of Agriculture and U.S. Department of Health and Human Services. Dietary Guidelines for Americans, 2020– 2025. 9th Edition. December 2020. Available at https://www.dietaryguidelines.gov/ (accessed 1/26/2021).* 4. National Academies of Sciences, Engineering and Medicine. Dietary Reference Intakes for Sodium and Potassium (March 2019). Washington, DC: The National Academies Press. Available at http:// www.nationalacademies.org/hmd/Reports/ 2019/dietary-reference-intakes-sodiumpotassium.aspx (accessed 01/28/2021). 5. Food and Drug Administration, ‘‘Memo: FDA’s Voluntary Sodium Reduction Goals Supplementary Memorandum to the Draft Guidance’’ (2016).* 6. Food and Drug Administration, ‘‘Memo: Survey of Microbiological Issues in FDARegulated Products’’ (2016).* 7. Food and Drug Administration, ‘‘Memo: Survey of Microbiological Issues in Meat and Poultry Products’’ (2016).* 8. Food and Drug Administration, ‘‘Memo: Salt Taste Preference and Sodium Alternatives’’ (2016).* 9. Food and Drug Administration, ‘‘Memo: Supplementary Target Development Example’’ (2016).* 10. Institute of Medicine. Strategies to Reduce Sodium Intake in the United States. Report Brief (April 2010). Washington DC: The National Academies Press. 11. National Salt Reduction Initiative Corporate Achievements. Available at: http:// www1.nyc.gov/assets/doh/downloads/pdf/ cardio/nsri-corporate-commitments.pdf (accessed 01/28/2021). 12. Curtis, CJ, Clapp J, Niederman SA, Wen Ng S, Angell SY., ‘‘US Food Industry Progress During the National Salt Reduction Initiative: 2009–2014.’’ American Journal of Public Health, 106(10) (October 1, 2016): pp. 1815–1819. 13. Graudal NA, Hubeck-Graudal T, Ju¨rgens G., ‘‘Effects of low sodium diet versus high sodium diet on blood pressure, renin, aldosterone, catecholamines, cholesterol, and triglyceride.’’ Cochrane Database of Systematic Reviews, Issue 4 (April 9, 2017). 14. Strom BL, Anderson CAM, Ix JH., ‘‘Sodium Reduction in Populations: Insights From the Institute of Medicine Committee.’’ Journal of the American Medical Association, 310(1) (July 3, 2013): pp. 31–32. 15. Newberry SJ, Chung M, Anderson C, Fu W, Chen C, Tang A, Zhao N, Booth M, Marks J, Hollands S, Motala A, Larkin K, Shanman R, Hempel S., ‘‘Sodium and Potassium Intake: Effects on Chronic Disease Outcomes and Risks.’’ Comparative Effectiveness Review, No. 206 (June 2018). Southern California Evidence-based Practice Center for the Agency for Healthcare Research and Quality. Available at https://effective healthcare.ahrq.gov/sites/default/files/pdf/ cer-206-report-sodium-potassium-update.pdf (accessed 01/28/2021).* 16. Kochanek KD, Xu J, Arias E., ‘‘Mortality in the United States, 2019,’’ NCHS Data Brief, No. 395 (December 2020): National Center for Health Statistics, Centers for Disease Control and Prevention, U.S. Dept. of Health and Human Services.* 17. Carvalho JJ, Baruzzi RG, Howard PF, Poulter N, Alpers MP, Franco LJ, et al., E:\FR\FM\14OCN1.SGM 14OCN1 lotter on DSK11XQN23PROD with NOTICES1 Federal Register / Vol. 86, No. 196 / Thursday, October 14, 2021 / Notices ‘‘Blood pressure in four remote populations in the INTERSALT Study.’’ Hypertension, 14(3) (1989): pp. 238–246. 18. Cogswell ME, Loria CM, Terry AL, Zhao L, Wang CY, Chen TC, Wright JD, Pfeiffer CM, Merritt R, Moy CS, Appel LJ., ‘‘Estimated 24-hour urinary sodium and potassium excretion in US adults.’’ Journal of the American Medical Association, 319(12) (March 27, 2018): pp. 1209–1220. 19. Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha D, et al., ‘‘Effects on blood pressure of reduced dietary sodium and the Dietary Approaches to Stop Hypertension (DASH) diet.’’ New England Journal of Medicine, 344(1) (Jan. 4, 2001): pp. 3–10. 20. He F, Li J, MacGregor G., ‘‘Effect of longer term modest salt reduction on blood pressure: Cochrane systematic review and meta-analysis of randomised trials.’’ BMJ, 346 (April 4, 2013). 21. Institute of Medicine. Dietary Reference Intakes for Water, Potassium, Sodium Chloride and Sulfate. 2005. Washington, DC: The National Academies Press. 22. Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, Hubbard VS, et al., ‘‘2013 AHA/ACC guideline on lifestyle management to reduce cardiovascular risk: a report of the American College of Cardiology/ American Heart Association Task Force on Practice Guidelines.’’ Journal of the American College of Cardiology, 2014;63(25 Pt B) (2014): pp. 2960–2084. 23. Dietary Guidelines Advisory Committee. Scientific Report of the 2020 Dietary Guidelines Advisory Committee: Advisory Report to the Secretary of Agriculture and the Secretary of Health and Human Services. 2020. Washington, DC: U.S. Department of Agriculture, Agricultural Research Service. Available at https:// www.dietaryguidelines.gov/sites/default/ files/2020-07/ScientificReport_of_the_ 2020DietaryGuidelinesAdvisoryCommittee_ first-print.pdf (accessed 2/5/2021).* 24. World Health Organization (WHO). Guideline: Sodium intake for adults and children. 2012. Geneva: WHO Press. Available at https://www.who.int/ publications/i/item/9789241504836 (accessed 01/28/2021). 25. Santos JA, Tekle D, Rosewarne E, Flexner N, Cobb L, Al-Jawaldeh A, Kim WJ, Breda J, Whiting S, Campbell N, Neal B, Webster J, Trieu K., ‘‘A Systematic Review of Salt Reduction Initiatives Around the World: A Midterm Evaluation of Progress Towards the 2025 Global Non-Communicable Diseases Salt Reduction Target.’’ Advances in Nutrition, nmab008 (March 7, 2021): p. 3. 26. McLaren L, Sumar N, Barberio AM, Trieu K, Lorenzetti DL, Tarasuk V, Webster J, Campbell NRC., ‘‘Population-level interventions in government jurisdictions for dietary sodium reduction.’’ Cochrane Database of Systematic Reviews, Issue 9 (Sept. 16, 2016). 27. Coxson PG, Cook NR, Joffres M, Hong Y, Orenstein D, Schmidt SM, BibbinsDomingo K., ‘‘Mortality benefits from US population-wide reduction in sodium consumption: projections from 3 modeling approaches.’’ Hypertension, 61(3) (Feb. 11, 2013): pp. 564–570. VerDate Sep<11>2014 17:44 Oct 13, 2021 Jkt 256001 28. Pearson-Stuttard J, Kypridemos C, Collins B, Mozaffarian D, Huang Y, Bandosz P, Capewell S, Whitsel L, Wilde P, O’Flaherty M, Micha R., ‘‘Estimating the health and economic effects of the proposed US Food and Drug Administration voluntary sodium reformulation: Microsimulation costeffectiveness analysis.’’ PLoS Medicine, 15(4) (April 10, 2018). 29. Smith-Spangler CM, Juusola JL, Enns EA, Owens DK, Garber AM., ‘‘Population strategies to decrease sodium intake and the burden of cardiovascular disease: a costeffectiveness analysis.’’ Annals of Internal Medicine, 152(8) (April 20, 2010): pp. 481– 487. 30. Dehmer SP, Cogswell ME, Ritchey MD, Hong Y, Maciosek MV, LaFrance AB, Roy K., ‘‘Health and Budgetary Impact of Achieving 10-Year U.S. Sodium Reduction Targets.’’ American Journal of Preventative Medicine, 2020 Aug; 59(2): 211–218. 31. National Salt and Sugar Reduction Initiative. Available at: https:// www1.nyc.gov/site/doh/health/health-topics/ national-salt-sugar-reduction-initiative.page (accessed 01/28/2021). 32. Webster JL, Dunford EK, Hawkes C, Neal BC., ‘‘Salt reduction initiatives around the world.’’ Journal of Hypertension, 29(6) (June 2011): pp. 1045–1050. 33. He FJ, Pombo-Rodrigues S, Macgregor GA., ‘‘Salt reduction in England from 2003 to 2011: its relationship to blood pressure, stroke and ischaemic heart disease mortality.’’ BMJ Open, 4(4) (April 14, 2014). 34. Public Health England, Salt Reduction Targets for 2024 (September 2020). Available at: https://assets.publishing.service.gov.uk/ government/uploads/system/uploads/ attachment_data/file/915406/2024_salt_ reduction_targets_070920-FINAL-1.pdf (accessed 01/28/2021). 35. Health Canada, Sodium Reduction in Processed Foods in Canada: An Evaluation of Progress toward Voluntary Targets from 2012 to 2016. Available at: https:// www.canada.ca/content/dam/hc-sc/ documents/services/food-nutrition/ legislation-guidelines/guidance-documents/ guidance-food-industry-reducing-sodiumprocessed-foods-progress-report-2017/pub1eng.pdf (accessed 01/28/2021). 36. Health Canada, Voluntary sodium reduction targets for processed foods 2020– 2025. Available at: https://www.canada.ca/ en/health-canada/services/food-nutrition/ healthy-eating/sodium/sodium-reducedtargets-2020-2025.html (accessed 1/28/2021). 37. Food and Drug Administration, ‘‘Memo: Documentation of access to and use of updated data sources from what was used for the draft Voluntary Sodium Reduction Goals Guidance’’ (2019).* Dated: October 8, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–22453 Filed 10–13–21; 8:45 am] BILLING CODE 4164–01–P PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 57159 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2021–D–1047] Q13 Continuous Manufacturing of Drug Substances and Drug Products; International Council for Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or the Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Q13 Continuous Manufacturing of Drug Substances and Drug Products.’’ The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance provides clarification on continuous manufacturing (CM) concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products. The draft guidance is intended to provide scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of CM. DATES: Submit either electronic or written comments on the draft guidance by December 13, 2021 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. ADDRESSES: You may submit comments on any guidance at any time as follows: SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https:// 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 E:\FR\FM\14OCN1.SGM 14OCN1

Agencies

[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57156-57159]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0055]


Voluntary Sodium Reduction Goals: Target Mean and Upper Bound 
Concentrations for Sodium in Commercially Processed, Packaged, and 
Prepared Foods; Guidance for Industry; Availability

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or we) is announcing the 
availability of a final guidance for industry entitled ``Voluntary 
Sodium Reduction Goals: Target Mean and Upper Bound Concentrations for 
Sodium in

[[Page 57157]]

Commercially Processed, Packaged, and Prepared Foods.'' The guidance 
describes our views on voluntary short-term (2.5-year) goals for sodium 
reduction in a variety of identified categories of foods that are 
commercially processed, packaged, or prepared. These goals are intended 
to address the excessive intake of sodium in the current population and 
promote improvements in public health.

DATES: The announcement of the guidance is published in the Federal 
Register on October 14, 2021.

ADDRESSES: You may submit either electronic or written comments on FDA 
guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://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): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, 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-2014-D-0055 for ``Voluntary Sodium Reduction Goals: Target Mean and 
Upper Bound Concentrations for Sodium in Commercially Processed, 
Packaged, and Prepared Foods.'' Received comments will be placed in the 
docket and, except for those submitted as ''Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     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.'' We will review 
this copy, including the claimed confidential information, in our 
consideration of comments. The second copy, which will have the claimed 
confidential information redacted/blacked out, will be available for 
public viewing and posted on https://www.regulations.gov. Submit both 
copies to the Dockets Management Staff. 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: 
https://www.govinfo.gov/content/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 https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.
    You may submit comments on any guidance at any time (see 21 CFR 
10.115(g)(5)).
    Submit written requests for single copies of the guidance to the 
Office of Food Additive Safety, Center for Food Safety and Applied 
Nutrition (HFS-255), Food and Drug Administration, 5001 Campus Dr., 
College Park, MD 20740. Send two self-addressed adhesive labels to 
assist that office in processing your request. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT: Kasey Heintz, Center for Food Safety 
and Applied Nutrition, Office of Food Additive Safety, Food and Drug 
Administration, 5001 Campus Dr., College Park, MD 20740, 240-402-1376; 
or Deirdre Jurand, Center for Food Safety and Applied Nutrition, Office 
of Regulations and Policy, Food and Drug Administration, 5001 Campus 
Dr., College Park, MD 20740, 240-402-2378.

SUPPLEMENTARY INFORMATION:

I. Background

    We are announcing the availability of a guidance for industry 
entitled ``Voluntary Sodium Reduction Goals: Target Mean and Upper 
Bound Concentrations for Sodium in Commercially Processed, Packaged, 
and Prepared Foods.'' We are issuing this guidance consistent with our 
good guidance practices regulation (21 CFR 10.115). The guidance 
represents the current thinking of FDA on this topic. It does not 
establish any rights for any person and is not binding on FDA or the 
public. You can use an alternative approach if it satisfies the 
requirements of the applicable statutes and regulations.
    In the Federal Register of June 2, 2016 (81 FR 35363), we made 
available a draft guidance for industry entitled ``Voluntary Sodium 
Reduction Goals: Target Mean and Upper Bound Concentrations for Sodium 
in Commercially Processed, Packaged, and Prepared Foods.'' The draft 
guidance described our tentative views on voluntary short-term and 
long-term goals for sodium reduction in a variety of identified 
categories of foods that are commercially processed, packaged, or 
prepared. Section IV of the Federal Register notice, ``Issues for 
Consideration,'' listed eight specific questions (or ``issues'') (81 FR 
35363 at 35366). The comment period for issues related primarily to 
short-term goals (Issues 1 through 4) was scheduled to close on August 
31, 2016, and the comment period for issues related primarily to long-
term goals (Issues 5 through 8) was scheduled to close on October 31, 
2016. In the Federal Register of August 30, 2017 (81 FR 59640), we 
published a notice extending the comment period for Issues 1 through 4 
until October 17, 2016, and for Issues 5 through 8 until December 2, 
2016.
    We received approximately 200 comments on the draft guidance. The 
comments generally recognized and

[[Page 57158]]

supported the benefit of sodium reduction efforts for public health. 
Many comments discussed the categories proposed in the draft guidance, 
including requests for greater clarity on our approach to establishing 
categories and suggestions for how certain categories should be 
changed. The comments also discussed sodium reduction efforts 
generally, including examples of successful sodium reduction across 
product categories or portfolios, examples of sodium reduction 
technologies, and examples of successful sodium reduction initiatives 
in other countries and jurisdictions. Some comments emphasized the 
barriers to sodium reduction, such as the time and cost associated with 
product reformulation, the standards of identity limitations for 
certain foods, and consumer preferences for certain kinds of 
ingredients. Several comments also requested more time to achieve the 
targets. Other general comments discussed the role of sodium in foods, 
recommended that we establish a monitoring plan, and recommended that 
we establish a comprehensive, national consumer education campaign for 
sodium reduction.
    After careful review of the comments, we have modified the guidance 
to clarify the voluntary sodium targets, timeframe, product categories, 
and descriptions. The guidance is intended to support an average sodium 
intake reduction to 3,000 milligrams/day. In addition, we have extended 
the milestone date for the short-term goals from 2 years to 2.5 years 
from the publication of the final guidance. The 2.5-year goals are 
intended to balance the need for broad and gradual reductions in sodium 
and what is publicly known about technical and market constraints on 
sodium reduction and reformulation. We are not finalizing the long-term 
(10-year) sodium reduction targets discussed in the draft guidance at 
this time. We revised the layout as well as category names and 
descriptions of the sodium guidance target table to improve 
understanding and provide additional clarity as to how foods should be 
categorized, and made changes to categories where they were supported 
by scientific data (e.g., we merged the ``Ready-to-Eat Cereal, Flakes'' 
category with the ``Ready-to-Eat Cereal, Puffed'' category and moved 
Provolone cheese from the ``Monterey Jack and Other Semi-Soft Cheese'' 
category to the ``Pasta Filata Cheese (soft)'' category). We also made 
technical corrections and editorial changes throughout the guidance to 
improve clarity, and included more recent data in our references.
    The guidance announced in this notice finalizes the draft guidance 
with respect to the short-term sodium reduction goals.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does 
refer to previously approved FDA collections of information. Therefore, 
clearance by the Office of Management and Budget (OMB) under the 
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not 
required for this guidance. The previously approved collections of 
information are subject to review by OMB under the PRA. The collections 
of information in 21 CFR part 101 have been approved under OMB control 
number 0910-0381. The collections of information in 21 CFR 101.11 have 
been approved under OMB control number 0910-0782.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/FoodGuidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov. Use the FDA website listed in the previous 
sentence to find the most current version of the guidance.

IV. References

    The following references marked with an asterisk (*) are on display 
at the Dockets Management Staff (see ADDRESSES) and are available for 
viewing by interested persons between 9 a.m. and 4 p.m., Monday through 
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public 
display at https://www.regulations.gov because they have copyright 
restriction or are not publications. Some may be available at the 
website address, if listed. References without asterisks are available 
for viewing only at the Dockets Management Staff or, in the case of 
non-publication references, at any website listed. FDA has verified the 
website addresses, as of the date this document publishes in the 
Federal Register, but websites are subject to change over time.

    1. Mattes RD and Donnelly D., ``Relative contributions of 
dietary sodium sources.'' Journal of the American College of 
Nutrition, 10(4) (Aug. 1991): pp. 383-393.
    2. Harnack LJ, Cogswell ME, Shikany JM, Gardner CD, Gillespie C, 
Loria CM, Zhou X, Yuan K, Steffen LM., ``Sources of Sodium in US 
Adults From 3 Geographic Regions.'' Circulation, 135 (May 9, 2017): 
pp. 1775-1783.
    3. U.S. Department of Agriculture and U.S. Department of Health 
and Human Services. Dietary Guidelines for Americans, 2020-2025. 9th 
Edition. December 2020. Available at https://www.dietaryguidelines.gov/ (accessed 1/26/2021).*
    4. National Academies of Sciences, Engineering and Medicine. 
Dietary Reference Intakes for Sodium and Potassium (March 2019). 
Washington, DC: The National Academies Press. Available at http://www.nationalacademies.org/hmd/Reports/2019/dietary-reference-intakes-sodium-potassium.aspx (accessed 01/28/2021).
    5. Food and Drug Administration, ``Memo: FDA's Voluntary Sodium 
Reduction Goals Supplementary Memorandum to the Draft Guidance'' 
(2016).*
    6. Food and Drug Administration, ``Memo: Survey of 
Microbiological Issues in FDA-Regulated Products'' (2016).*
    7. Food and Drug Administration, ``Memo: Survey of 
Microbiological Issues in Meat and Poultry Products'' (2016).*
    8. Food and Drug Administration, ``Memo: Salt Taste Preference 
and Sodium Alternatives'' (2016).*
    9. Food and Drug Administration, ``Memo: Supplementary Target 
Development Example'' (2016).*
    10. Institute of Medicine. Strategies to Reduce Sodium Intake in 
the United States. Report Brief (April 2010). Washington DC: The 
National Academies Press.
    11. National Salt Reduction Initiative Corporate Achievements. 
Available at: http://www1.nyc.gov/assets/doh/downloads/pdf/cardio/nsri-corporate-commitments.pdf (accessed 01/28/2021).
    12. Curtis, CJ, Clapp J, Niederman SA, Wen Ng S, Angell SY., 
``US Food Industry Progress During the National Salt Reduction 
Initiative: 2009-2014.'' American Journal of Public Health, 106(10) 
(October 1, 2016): pp. 1815-1819.
    13. Graudal NA, Hubeck-Graudal T, J[uuml]rgens G., ``Effects of 
low sodium diet versus high sodium diet on blood pressure, renin, 
aldosterone, catecholamines, cholesterol, and triglyceride.'' 
Cochrane Database of Systematic Reviews, Issue 4 (April 9, 2017).
    14. Strom BL, Anderson CAM, Ix JH., ``Sodium Reduction in 
Populations: Insights From the Institute of Medicine Committee.'' 
Journal of the American Medical Association, 310(1) (July 3, 2013): 
pp. 31-32.
    15. Newberry SJ, Chung M, Anderson C, Fu W, Chen C, Tang A, Zhao 
N, Booth M, Marks J, Hollands S, Motala A, Larkin K, Shanman R, 
Hempel S., ``Sodium and Potassium Intake: Effects on Chronic Disease 
Outcomes and Risks.'' Comparative Effectiveness Review, No. 206 
(June 2018). Southern California Evidence-based Practice Center for 
the Agency for Healthcare Research and Quality. Available at https://effectivehealthcare.ahrq.gov/sites/default/files/pdf/cer-206-report-sodium-potassium-update.pdf (accessed 01/28/2021).*
    16. Kochanek KD, Xu J, Arias E., ``Mortality in the United 
States, 2019,'' NCHS Data Brief, No. 395 (December 2020): National 
Center for Health Statistics, Centers for Disease Control and 
Prevention, U.S. Dept. of Health and Human Services.*
    17. Carvalho JJ, Baruzzi RG, Howard PF, Poulter N, Alpers MP, 
Franco LJ, et al.,

[[Page 57159]]

``Blood pressure in four remote populations in the INTERSALT 
Study.'' Hypertension, 14(3) (1989): pp. 238-246.
    18. Cogswell ME, Loria CM, Terry AL, Zhao L, Wang CY, Chen TC, 
Wright JD, Pfeiffer CM, Merritt R, Moy CS, Appel LJ., ``Estimated 
24-hour urinary sodium and potassium excretion in US adults.'' 
Journal of the American Medical Association, 319(12) (March 27, 
2018): pp. 1209-1220.
    19. Sacks FM, Svetkey LP, Vollmer WM, Appel LJ, Bray GA, Harsha 
D, et al., ``Effects on blood pressure of reduced dietary sodium and 
the Dietary Approaches to Stop Hypertension (DASH) diet.'' New 
England Journal of Medicine, 344(1) (Jan. 4, 2001): pp. 3-10.
    20. He F, Li J, MacGregor G., ``Effect of longer term modest 
salt reduction on blood pressure: Cochrane systematic review and 
meta-analysis of randomised trials.'' BMJ, 346 (April 4, 2013).
    21. Institute of Medicine. Dietary Reference Intakes for Water, 
Potassium, Sodium Chloride and Sulfate. 2005. Washington, DC: The 
National Academies Press.
    22. Eckel RH, Jakicic JM, Ard JD, de Jesus JM, Houston Miller N, 
Hubbard VS, et al., ``2013 AHA/ACC guideline on lifestyle management 
to reduce cardiovascular risk: a report of the American College of 
Cardiology/American Heart Association Task Force on Practice 
Guidelines.'' Journal of the American College of Cardiology, 
2014;63(25 Pt B) (2014): pp. 2960-2084.
    23. Dietary Guidelines Advisory Committee. Scientific Report of 
the 2020 Dietary Guidelines Advisory Committee: Advisory Report to 
the Secretary of Agriculture and the Secretary of Health and Human 
Services. 2020. Washington, DC: U.S. Department of Agriculture, 
Agricultural Research Service. Available at https://www.dietaryguidelines.gov/sites/default/files/2020-07/ScientificReport_of_the_2020DietaryGuidelinesAdvisoryCommittee_first-print.pdf (accessed 2/5/2021).*
    24. World Health Organization (WHO). Guideline: Sodium intake 
for adults and children. 2012. Geneva: WHO Press. Available at 
https://www.who.int/publications/i/item/9789241504836 (accessed 01/
28/2021).
    25. Santos JA, Tekle D, Rosewarne E, Flexner N, Cobb L, Al-
Jawaldeh A, Kim WJ, Breda J, Whiting S, Campbell N, Neal B, Webster 
J, Trieu K., ``A Systematic Review of Salt Reduction Initiatives 
Around the World: A Midterm Evaluation of Progress Towards the 2025 
Global Non-Communicable Diseases Salt Reduction Target.'' Advances 
in Nutrition, nmab008 (March 7, 2021): p. 3.
    26. McLaren L, Sumar N, Barberio AM, Trieu K, Lorenzetti DL, 
Tarasuk V, Webster J, Campbell NRC., ``Population-level 
interventions in government jurisdictions for dietary sodium 
reduction.'' Cochrane Database of Systematic Reviews, Issue 9 (Sept. 
16, 2016).
    27. Coxson PG, Cook NR, Joffres M, Hong Y, Orenstein D, Schmidt 
SM, Bibbins-Domingo K., ``Mortality benefits from US population-wide 
reduction in sodium consumption: projections from 3 modeling 
approaches.'' Hypertension, 61(3) (Feb. 11, 2013): pp. 564-570.
    28. Pearson-Stuttard J, Kypridemos C, Collins B, Mozaffarian D, 
Huang Y, Bandosz P, Capewell S, Whitsel L, Wilde P, O'Flaherty M, 
Micha R., ``Estimating the health and economic effects of the 
proposed US Food and Drug Administration voluntary sodium 
reformulation: Microsimulation cost-effectiveness analysis.'' PLoS 
Medicine, 15(4) (April 10, 2018).
    29. Smith-Spangler CM, Juusola JL, Enns EA, Owens DK, Garber 
AM., ``Population strategies to decrease sodium intake and the 
burden of cardiovascular disease: a cost-effectiveness analysis.'' 
Annals of Internal Medicine, 152(8) (April 20, 2010): pp. 481-487.
    30. Dehmer SP, Cogswell ME, Ritchey MD, Hong Y, Maciosek MV, 
LaFrance AB, Roy K., ``Health and Budgetary Impact of Achieving 10-
Year U.S. Sodium Reduction Targets.'' American Journal of 
Preventative Medicine, 2020 Aug; 59(2): 211-218.
    31. National Salt and Sugar Reduction Initiative. Available at: 
https://www1.nyc.gov/site/doh/health/health-topics/national-salt-sugar-reduction-initiative.page (accessed 01/28/2021).
    32. Webster JL, Dunford EK, Hawkes C, Neal BC., ``Salt reduction 
initiatives around the world.'' Journal of Hypertension, 29(6) (June 
2011): pp. 1045-1050.
    33. He FJ, Pombo-Rodrigues S, Macgregor GA., ``Salt reduction in 
England from 2003 to 2011: its relationship to blood pressure, 
stroke and ischaemic heart disease mortality.'' BMJ Open, 4(4) 
(April 14, 2014).
    34. Public Health England, Salt Reduction Targets for 2024 
(September 2020). Available at: https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/915406/2024_salt_reduction_targets_070920-FINAL-1.pdf (accessed 01/28/2021).
    35. Health Canada, Sodium Reduction in Processed Foods in 
Canada: An Evaluation of Progress toward Voluntary Targets from 2012 
to 2016. Available at: https://www.canada.ca/content/dam/hc-sc/documents/services/food-nutrition/legislation-guidelines/guidance-documents/guidance-food-industry-reducing-sodium-processed-foods-progress-report-2017/pub1-eng.pdf (accessed 01/28/2021).
    36. Health Canada, Voluntary sodium reduction targets for 
processed foods 2020-2025. Available at: https://www.canada.ca/en/health-canada/services/food-nutrition/healthy-eating/sodium/sodium-reduced-targets-2020-2025.html (accessed 1/28/2021).
    37. Food and Drug Administration, ``Memo: Documentation of 
access to and use of updated data sources from what was used for the 
draft Voluntary Sodium Reduction Goals Guidance'' (2019).*

    Dated: October 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22453 Filed 10-13-21; 8:45 am]
BILLING CODE 4164-01-P