E11A Pediatric Extrapolation; International Council for Harmonisation; Draft Guidance for Industry; Availability, 52788-52790 [2022-18517]

Download as PDF 52788 Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices Q&As provide recommendations on an integrated risk assessment and how it can inform the design of clinical investigations and the interpretation of their results (ICH S7B Q&As Q17 (1.1) and Q18 (1.2)); best-practice considerations for in vitro (ICH S7B Q&As Q 19 (2.1) to Q23 (2.5)) and in vivo (ICH S7B Q&As Q24 (3.1) to Q28 (3.5)) studies; and principles for proarrhythmia models, including in silico (ICH S7B Q&As Q30 (4.1) and 4.2). The guidance is intended to provide a harmonized approach to integrate nonclinical and clinical information for proarrhythmia risk assessment to streamline drug development and provide clarity on regulatory decision making. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). This guidance represents the current thinking of FDA on ‘‘E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential—Questions and Answers.’’ 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. khammond on DSKJM1Z7X2PROD with NOTICES 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 for submitting investigational new drug applications are approved under OMB control number 0910–0014. The collections of information for submitting new drug applications are approved under OMB control number 0910–0001. The collections of information for submitting biologics license applications are approved under OMB control number 0910–0338. II. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.regulations.gov, https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatory- VerDate Sep<11>2014 17:01 Aug 26, 2022 Jkt 256001 information-biologics/biologicsguidances. Dated: August 22, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–18515 Filed 8–26–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2022–D–1562] E11A Pediatric Extrapolation; 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 Agency) is announcing the availability of a draft guidance for industry entitled ‘‘E11A Pediatric Extrapolation.’’ The draft guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The draft guidance provides a comprehensive and systematic approach to the use of pediatric extrapolation during drug development. The draft guidance also discusses study designs and statistical methodologies, including modeling and simulation, that can be utilized to develop and implement a pediatric extrapolation approach. The draft guidance is intended to provide recommendations for the use of pediatric extrapolation during drug development, which, when used appropriately, can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children. DATES: Submit either electronic or written comments on the draft guidance by October 28, 2022 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, PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 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– 2022–D–1562 for ‘‘E11A Pediatric Extrapolation.’’ Received comments will be placed in the docket and, except for those submitted as ‘‘Confidential Submissions,’’ are 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 E:\FR\FM\29AUN1.SGM 29AUN1 khammond on DSKJM1Z7X2PROD with NOTICES Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices 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 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 draft 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 guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Lynne Yao, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 5412, Silver Spring, MD 20993–0002, 301–796–2141, Lynne.Yao@fda.hhs.gov. 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. VerDate Sep<11>2014 17:01 Aug 26, 2022 Jkt 256001 SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘E11A Pediatric Extrapolation.’’ The draft guideline 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 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 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 for 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 April 2022, the ICH Assembly endorsed the draft guideline entitled PO 00000 Frm 00053 Fmt 4703 Sfmt 4703 52789 ‘‘E11A Pediatric Extrapolation’’ and agreed that the guideline should be made available for public comment. The draft guideline is the product of the Efficacy Expert Working Group of the ICH. Comments about this draft will be considered by FDA and the Efficacy Expert Working Group. The draft guidance provides a comprehensive and systematic approach to the use of pediatric extrapolation during drug development. The guidance also discusses study designs and statistical methodologies, including modeling and simulation, that can be utilized to develop and implement a pediatric extrapolation approach. The intent of the guidance is to provide recommendations for the use of pediatric extrapolation during drug development, which, when used appropriately, can increase the efficiency of pediatric drug development and accelerate the availability of safe and effective drugs approved for use in children. 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 ‘‘E11A Pediatric Extrapolation.’’ 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 for submitting investigational new drug applications have been approved under OMB control number 0910–0014. The collections of information for submitting new drug applications have been approved under OMB control number 0910–0001. The collections of information for submitting biologics license applications have been approved under OMB control number 0910–0338. The collection of information for implementation of improved and efficient approaches to clinical trial design have been approved under OMB control number 0910–0843. E:\FR\FM\29AUN1.SGM 29AUN1 52790 Federal Register / Vol. 87, No. 166 / Monday, August 29, 2022 / Notices III. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.regulations.gov, https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ regulatory-information/search-fdaguidance-documents, or https:// www.fda.gov/vaccines-blood-biologics/ guidance-compliance-regulatoryinformation-biologics/biologicsguidances. Dated: August 22, 2022. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2022–18517 Filed 8–26–22; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES countermeasure priority review vouchers and the approval of products for which a voucher was redeemed. FDA has determined that the application for MOUNJARO (tirzepatide) injection, approved May 13, 2022, meets the redemption criteria. For further information about the Material Threat Medical Countermeasure Priority Review Voucher Program and for a link to the full text of section 565A of the FD&C Act, go to https://www.fda.gov/ emergency-preparedness-and-response/ mcm-legal-regulatory-and-policyframework/21st-century-cures-act-mcmrelated-cures-provisions. For further information about MOUNJARO (tirzepatide) injection, go to the ‘‘Drugs@ FDA’’ website at https:// www.accessdata.fda.gov/scripts/cder/ daf/. Dated: August 23, 2022. Lauren K. Roth, Associate Commissioner for Policy. Food and Drug Administration [Docket No. FDA–2019–N–0895] [FR Doc. 2022–18523 Filed 8–26–22; 8:45 am] Notice of Approval of Product Under Voucher: Material Threat Medical Countermeasure Priority Review Voucher AGENCY: BILLING CODE 4164–01–P Food and Drug Administration, HHS. ACTION: Food and Drug Administration Notice. [Docket No. FDA–2021–N–0335] The Food and Drug Administration (FDA) is announcing the approval of a product redeeming a priority review voucher. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the 21st Century Cures Act, authorizes FDA to award priority review vouchers to sponsors of a material threat medical countermeasure application that meets certain criteria upon approval of such application. FDA is required to publish notice of the issuance of priority review vouchers as well as the approval of products redeeming a priority review voucher. FDA has determined that the application for MOUNJARO (tirzepatide) injection, approved May 13, 2022, meets the redemption criteria. FOR FURTHER INFORMATION CONTACT: Elizabeth Sadove, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Silver Spring, MD 20993–0002, 301–796–8515 (this is not a toll-free number), email: EUA.OCET@ fda.hhs.gov. SUPPLEMENTARY INFORMATION: Under section 565A of the FD&C Act (21 U.S.C. 360bbb–4a), which was added by section 3086 of the 21st Century Cures Act (Pub. L. 114–255), FDA will report the issuance of material threat medical SUMMARY: khammond on DSKJM1Z7X2PROD with NOTICES DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Sep<11>2014 17:01 Aug 26, 2022 Jkt 256001 Authorization of Emergency Use of a Biological Product During the COVID– 19 Pandemic; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the issuance of an Emergency Use Authorization (EUA) (the Authorization) under the Federal Food, Drug, and Cosmetic Act (FD&C Act) for use during the COVID–19 pandemic. FDA has issued one Authorization for a biological product as requested by Novavax, Inc. The Authorization contains, among other things, conditions on the emergency use of the authorized product. The Authorization follows the February 4, 2020, determination by the Secretary of Health and Human Services (HHS) that there is a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens living abroad and that involves a novel (new) coronavirus. The virus, now named SARS–CoV–2, causes the illness COVID–19. On the basis of such determination, the Secretary of HHS declared on March 27, 2020, that SUMMARY: PO 00000 Frm 00054 Fmt 4703 Sfmt 4703 circumstances exist justifying the authorization of emergency use of drugs and biological products during the COVID–19 pandemic, pursuant to the FD&C Act, subject to the terms of any authorization issued under that section. The Authorization, which includes an explanation of the reasons for issuance, is reprinted in this document. DATES: The Authorization is effective as of July 13, 2022. ADDRESSES: Submit written requests for a single copy of the EUA to the Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4338, Silver Spring, MD 20993– 0002. Send one self-addressed adhesive label to assist that office in processing your request or include a Fax number to which the Authorization may be sent. See the SUPPLEMENTARY INFORMATION section for electronic access to the Authorization. FOR FURTHER INFORMATION CONTACT: Michael Mair, Office of Counterterrorism and Emerging Threats, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 1, Rm. 4340, Silver Spring, MD 20993–0002, 301–796–8510 (this is not a toll-free number). SUPPLEMENTARY INFORMATION: I. Background Section 564 of the FD&C Act (21 U.S.C. 360bbb–3) allows FDA to strengthen public health protections against biological, chemical, nuclear, and radiological agents. Among other things, section 564 of the FD&C Act allows FDA to authorize the use of an unapproved medical product or an unapproved use of an approved medical product in certain situations. With this EUA authority, FDA can help ensure that medical countermeasures may be used in emergencies to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by biological, chemical, nuclear, or radiological agents when there are no adequate, approved, and available alternatives (among other criteria). II. Criteria for EUA Authorization Section 564(b)(1) of the FD&C Act provides that, before an EUA may be issued, the Secretary of HHS must declare that circumstances exist justifying the authorization based on one of the following grounds: (1) a determination by the Secretary of Homeland Security that there is a domestic emergency, or a significant potential for a domestic emergency, involving a heightened risk of attack with a biological, chemical, radiological, E:\FR\FM\29AUN1.SGM 29AUN1

Agencies

[Federal Register Volume 87, Number 166 (Monday, August 29, 2022)]
[Notices]
[Pages 52788-52790]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-18517]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2022-D-1562]


E11A Pediatric Extrapolation; 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 Agency) is announcing 
the availability of a draft guidance for industry entitled ``E11A 
Pediatric Extrapolation.'' The draft guidance was prepared under the 
auspices of the International Council for Harmonisation of Technical 
Requirements for Pharmaceuticals for Human Use (ICH). The draft 
guidance provides a comprehensive and systematic approach to the use of 
pediatric extrapolation during drug development. The draft guidance 
also discusses study designs and statistical methodologies, including 
modeling and simulation, that can be utilized to develop and implement 
a pediatric extrapolation approach. The draft guidance is intended to 
provide recommendations for the use of pediatric extrapolation during 
drug development, which, when used appropriately, can increase the 
efficiency of pediatric drug development and accelerate the 
availability of safe and effective drugs approved for use in children.

DATES: Submit either electronic or written comments on the draft 
guidance by October 28, 2022 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 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-2022-D-1562 for ``E11A Pediatric Extrapolation.'' Received comments 
will be placed in the docket and, except for those submitted as 
``Confidential Submissions,'' are 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

[[Page 52789]]

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 draft 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 guidance document.

FOR FURTHER INFORMATION CONTACT: 
    Regarding the guidance: Lynne Yao, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
22, Rm. 5412, Silver Spring, MD 20993-0002, 301-796-2141, 
[email protected].
    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 ``E11A Pediatric Extrapolation.'' The draft guideline 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 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 for 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 April 2022, the ICH Assembly endorsed the draft guideline 
entitled ``E11A Pediatric Extrapolation'' and agreed that the guideline 
should be made available for public comment. The draft guideline is the 
product of the Efficacy Expert Working Group of the ICH. Comments about 
this draft will be considered by FDA and the Efficacy Expert Working 
Group.
    The draft guidance provides a comprehensive and systematic approach 
to the use of pediatric extrapolation during drug development. The 
guidance also discusses study designs and statistical methodologies, 
including modeling and simulation, that can be utilized to develop and 
implement a pediatric extrapolation approach. The intent of the 
guidance is to provide recommendations for the use of pediatric 
extrapolation during drug development, which, when used appropriately, 
can increase the efficiency of pediatric drug development and 
accelerate the availability of safe and effective drugs approved for 
use in children.
    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 ``E11A Pediatric Extrapolation.'' 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 for submitting investigational new drug applications 
have been approved under OMB control number 0910-0014. The collections 
of information for submitting new drug applications have been approved 
under OMB control number 0910-0001. The collections of information for 
submitting biologics license applications have been approved under OMB 
control number 0910-0338. The collection of information for 
implementation of improved and efficient approaches to clinical trial 
design have been approved under OMB control number 0910-0843.

[[Page 52790]]

III. Electronic Access

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

    Dated: August 22, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-18517 Filed 8-26-22; 8:45 am]
BILLING CODE 4164-01-P

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