Q13 Continuous Manufacturing of Drug Substances and Drug Products; International Council for Harmonisation; Draft Guidance for Industry; Availability, 57159-57161 [2021-22451]

Download as PDF 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 57160 Federal Register / Vol. 86, No. 196 / Thursday, October 14, 2021 / Notices lotter on DSK11XQN23PROD with NOTICES1 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– 2021–D–1047 for ‘‘Q13 Continuous Manufacturing of Drug Substances and Drug Products.’’ 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.’’ The Agency will review this copy, including the claimed confidential information, in its 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 VerDate Sep<11>2014 17:44 Oct 13, 2021 Jkt 256001 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 draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002, or the Office of Communication, Outreach and Development, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your requests. The guidance may also be obtained by mail by calling CBER at 1– 800–835–4709 or 240–402–8010. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Sau Lee, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 4182, Silver Spring, MD 20993–0002, 301–796–2905; or Stephen Ripley, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993–0002, 240– 402–7911. Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6364, Silver Spring, MD 20993–0002, 301–796–5259, Jill.Adleberg@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA 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 ICH. ICH has the mission PO 00000 Frm 00038 Fmt 4703 Sfmt 4703 of achieving greater regulatory harmonization worldwide to ensure that safe, effective, high-quality medicines are developed, registered, and maintained in the most resourceefficient manner. By harmonizing the regulatory requirements in regions around the world, ICH guidelines have substantially reduced duplicative clinical studies, prevented unnecessary animal studies, standardized the reporting of important safety information, standardized marketing application submissions, and made many other improvements in the quality of global drug development and manufacturing and the products available to patients. The six Founding Members of the ICH are: FDA; the Pharmaceutical Research and Manufacturers of America; the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; and the Japanese Pharmaceutical Manufacturers Association. The Standing Members of the ICH Association include Health Canada and Swissmedic. Additionally, the Membership of ICH has expanded to include other regulatory authorities and industry associations from around the world (refer to https://www.ich.org). ICH works by involving technical experts from both regulators and industry parties in detailed technical harmonization work and the application of a science-based approach to harmonization through a consensusdriven process that results in the development of ICH guidelines. The regulators around the world are committed to consistently adopting these consensus-based guidelines, realizing the benefits for patients and industry. As a Founding Regulatory Member of ICH, FDA plays a major role in the development of each of the ICH guidelines, which FDA then adopts and issues as guidance for industry. FDA’s guidance documents do not establish legally enforceable responsibilities. Instead, they describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. In June 2021, the ICH Assembly endorsed the draft guideline entitled ‘‘Q13 Continuous Manufacturing of Drug Substances and Drug Products’’ and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Quality Expert Working Group of the ICH. Comments about this draft will be E:\FR\FM\14OCN1.SGM 14OCN1 Federal Register / Vol. 86, No. 196 / Thursday, October 14, 2021 / Notices considered by FDA and the Quality Expert Working Group. The draft guidance provides guidance on the development, implementation, operation, and lifecycle management of CM. This draft guidance has been left in the original ICH format. The final guidance will be reformatted and edited to conform with FDA’s good guidance practices regulation (21 CFR 10.115) and style before publication. The draft guidance, when finalized, will represent the current thinking of FDA on ‘‘Q13 Continuous Manufacturing of Drug Substances and Drug Products.’’ 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 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 312 have been approved under OMB control number 0910–0014; the collections of information in 21 CFR part 314 have been approved under OMB control number 0910–0001; the collections of information in 21 CFR part 601 have been approved under OMB control number 0910–0338; and the collections of information in 21 CFR parts 210 and 211 have been approved under OMB control number 0910–0139. lotter on DSK11XQN23PROD with NOTICES1 III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/regulatory-information/ search-fda-guidance-documents, or https://www.regulations.gov. Dated: October 8, 2021. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2021–22451 Filed 10–13–21; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 17:44 Oct 13, 2021 Jkt 256001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the COVID–19 Health Equity Task Force Office of the Assistant Secretary for Health, Office of the Secretary, Department of Health and Human Services. ACTION: Notice of meeting. AGENCY: As required by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services (HHS) is hereby giving notice that the COVID–19 Health Equity Task Force (Task Force) will hold a virtual meeting on October 28, 2021. The purpose of this meeting is to present and vote on the Task Force Final Report with recommended Implementation Plan and Accountability Plan for mitigating inequities caused or exacerbated by the COVID–19 pandemic and for preventing such inequities in the future. This meeting is open to the public and will be live-streamed at www.hhs.gov/live. Information about the meeting will be posted on the HHS Office of Minority Health website: www.minorityhealth.hhs.gov/ healthequitytaskforce/ prior to the meeting. SUMMARY: The Task Force meeting will be held on Thursday, October 28, 2021, from 1 p.m. to approximately 4 p.m. ET (date and time are tentative and subject to change). The confirmed time and agenda will be posted on the COVID–19 Health Equity Task Force web page: www.minorityhealth.hhs.gov/ healthequitytaskforce/ when this information becomes available. FOR FURTHER INFORMATION CONTACT: Samuel Wu, Designated Federal Officer for the Task Force; Office of Minority Health, Department of Health and Human Services, Tower Building, 1101 Wootton Parkway, Suite 100, Rockville, Maryland 20852. Phone: 240–453–6173; email: COVID19HETF@hhs.gov. SUPPLEMENTARY INFORMATION: Background: The COVID–19 Health Equity Task Force (Task Force) was established by Executive Order 13995, dated January 21, 2021. The Task Force is tasked with providing specific recommendations to the President, through the Coordinator of the COVID– 19 Response and Counselor to the President (COVID–19 Response Coordinator), for mitigating the health inequities caused or exacerbated by the COVID–19 pandemic and for preventing such inequities in the future. The Task Force shall submit a final report to the COVID–19 Response Coordinator DATES: PO 00000 Frm 00039 Fmt 4703 Sfmt 4703 57161 addressing any ongoing health inequities faced by COVID–19 survivors that may merit a public health response, describing the factors that contributed to disparities in COVID–19 outcomes, and recommending actions to combat such disparities in future pandemic responses. The meeting is open to the public and will be live-streamed at www.hhs.gov/ live. No registration is required. A public comment session will be held during the meeting. Pre-registration is required to provide public comment during the meeting. To pre-register, please send an email to COVID19HETF@hhs.gov and include your name, title, and organization by close of business on Friday, October 22, 2021. Comments will be limited to no more than three minutes per speaker and should be pertinent to the meeting discussion. Individuals are encouraged to provide a written statement of any public comment(s) for accurate minutetaking purposes. If you decide you would like to provide public comment but do not pre-register, you may submit your written statement by emailing COVID19HETF@hhs.gov no later than close of business on Thursday, November 4, 2021. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should contact: COVID19HETF@hhs.gov and reference this meeting. Requests for special accommodations should be made at least 10 business days prior to the meeting. Dated: October 7, 2021. Samuel Wu, Designated Federal Officer, COVID–19 Health Equity Task Force. [FR Doc. 2021–22330 Filed 10–13–21; 8:45 am] BILLING CODE 4150–29–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Meeting of the Secretary’s Advisory Committee on Human Research Protections Office of the Secretary, Office of the Assistant Secretary for Health, Department of Health and Human Services (HHS). ACTION: Notice. AGENCY: Pursuant to Section 10(a) of the Federal Advisory Committee Act, notice is hereby given that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. SUMMARY: E:\FR\FM\14OCN1.SGM 14OCN1

Agencies

[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Pages 57159-57161]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-22451]


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

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.

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

SUMMARY: 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:

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

[[Page 57160]]

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-2021-D-1047 for ``Q13 Continuous Manufacturing of Drug Substances 
and Drug Products.'' 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.'' The Agency will 
review this copy, including the claimed confidential information, in 
its 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 draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10001 New Hampshire Ave., 
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or the 
Office of Communication, Outreach and Development, Center for Biologics 
Evaluation and Research (CBER), Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send 
one self-addressed adhesive label to assist that office in processing 
your requests. The guidance may also be obtained by mail by calling 
CBER at 1-800-835-4709 or 240-402-8010. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the draft guidance 
document.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the guidance: Sau Lee, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 4182, Silver Spring, MD 20993-0002, 301-796-2905; or Stephen 
Ripley, Center for Biologics Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver 
Spring, MD 20993-0002, 240-402-7911.
    Regarding the ICH: Jill Adleberg, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 6364, Silver Spring, MD 20993-0002, 301-796-5259, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    FDA 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 ICH. 
ICH has the mission of achieving greater regulatory harmonization 
worldwide to ensure that safe, effective, high-quality medicines are 
developed, registered, and maintained in the most resource-efficient 
manner.
    By harmonizing the regulatory requirements in regions around the 
world, ICH guidelines have substantially reduced duplicative clinical 
studies, prevented unnecessary animal studies, standardized the 
reporting of important safety information, standardized marketing 
application submissions, and made many other improvements in the 
quality of global drug development and manufacturing and the products 
available to patients.
    The six Founding Members of the ICH are: FDA; the Pharmaceutical 
Research and Manufacturers of America; the European Commission; the 
European Federation of Pharmaceutical Industries Associations; the 
Japanese Ministry of Health, Labour, and Welfare; and the Japanese 
Pharmaceutical Manufacturers Association. The Standing Members of the 
ICH Association include Health Canada and Swissmedic. Additionally, the 
Membership of ICH has expanded to include other regulatory authorities 
and industry associations from around the world (refer to https://www.ich.org).
    ICH works by involving technical experts from both regulators and 
industry parties in detailed technical harmonization work and the 
application of a science-based approach to harmonization through a 
consensus-driven process that results in the development of ICH 
guidelines. The regulators around the world are committed to 
consistently adopting these consensus-based guidelines, realizing the 
benefits for patients and industry.
    As a Founding Regulatory Member of ICH, FDA plays a major role in 
the development of each of the ICH guidelines, which FDA then adopts 
and issues as guidance for industry. FDA's guidance documents do not 
establish legally enforceable responsibilities. Instead, they describe 
the Agency's current thinking on a topic and should be viewed only as 
recommendations, unless specific regulatory or statutory requirements 
are cited.
    In June 2021, the ICH Assembly endorsed the draft guideline 
entitled ``Q13 Continuous Manufacturing of Drug Substances and Drug 
Products'' and agreed that the guideline should be made available for 
public comment. The draft guideline is the product of the Quality 
Expert Working Group of the ICH. Comments about this draft will be

[[Page 57161]]

considered by FDA and the Quality Expert Working Group.
    The draft guidance provides guidance on the development, 
implementation, operation, and lifecycle management of CM.
    This draft guidance has been left in the original ICH format. The 
final guidance will be reformatted and edited to conform with FDA's 
good guidance practices regulation (21 CFR 10.115) and style before 
publication. The draft guidance, when finalized, will represent the 
current thinking of FDA on ``Q13 Continuous Manufacturing of Drug 
Substances and Drug Products.'' 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 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 312 have been approved under OMB control 
number 0910-0014; the collections of information in 21 CFR part 314 
have been approved under OMB control number 0910-0001; the collections 
of information in 21 CFR part 601 have been approved under OMB control 
number 0910-0338; and the collections of information in 21 CFR parts 
210 and 211 have been approved under OMB control number 0910-0139.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance 
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: October 8, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-22451 Filed 10-13-21; 8:45 am]
BILLING CODE 4164-01-P