E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Draft Guidance for Industry; Availability, 83847-83848 [2016-28048]

Download as PDF Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices phase of the regulatory review period, while 780 days occurred during the approval phase. These periods of time were derived from the following dates: 1. The date an exemption under section 505(i) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: October 15, 2003. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on October 15, 2003. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): March 18, 2013. FDA has verified the applicant’s claim that the biologics license application (BLA) for ANAVIP (BLA 125488/0) was initially submitted on March 18, 2013. 3. The date the application was approved: May 6, 2015. FDA has verified the applicant’s claim that BLA 125488/0 was approved on May 6, 2015. This determination of the regulatory review period establishes the maximum potential length of a patent extension. However, the USPTO applies several statutory limitations in its calculations of the actual period for patent extension. In its application for patent extension, this applicant seeks 5 years of patent term extension. sradovich on DSK3GMQ082PROD with NOTICES III. Petitions Anyone with knowledge that any of the dates as published are incorrect may submit either electronic or written comments and ask for a redetermination (see DATES). Furthermore, any interested person may petition FDA for a determination regarding whether the applicant for extension acted with due diligence during the regulatory review period. To meet its burden, the petition must be timely (see DATES) and contain sufficient facts to merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41–42, 1984.) Petitions should be in the format specified in 21 CFR 10.30. Submit petitions electronically to https://www.regulations.gov at Docket No. FDA–2013–S–0610. Submit written petitions (two copies are required) to the Division of Dockets Management (HFA– 305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Dated: November 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–28049 Filed 11–21–16; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 16:52 Nov 21, 2016 Jkt 241001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2016–D–3848] E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; 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 entitled ‘‘E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population’’ (E11(R1) addendum). The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance is an addendum to the guidance entitled ‘‘E11 Clinical Investigation of Medicinal Products in the Pediatric Population’’ (ICH E11 guidance). The draft guidance is intended to update the ICH E11 guidance and provide clarification and current regulatory perspective on topics in global pediatric drug development. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017. SUMMARY: ADDRESSES: You may submit comments 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 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 83847 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): Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. • For written/paper comments submitted to the Division of Dockets Management, 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– 2016–D–3848 for ‘‘E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Draft Guidance for Industry; Availability.’’ 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 Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. • 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 Division of Dockets Management. 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 E:\FR\FM\22NON1.SGM 22NON1 83848 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices 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: http://www.fda.gov/ regulatoryinformation/dockets/ default.htm. 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Submit written requests for single copies of the draft guidance to the Division of Drug Information, Center for Drug Evaluation and Research (CDER), 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 draft guidance document. sradovich on DSK3GMQ082PROD with NOTICES 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, Silver Spring, MD 20993–0002, 301–796–2141; or CBER’s Office of Communication, Outreach and Development; Center for Biologics Evaluation and Research; Food and Drug Administration; 10903 New Hampshire Ave., Bldg. 71; Silver Spring, MD 20993–0002; ocod@fda.hhs.gov; 1– 800–835–4709 or 240–402–8010. Regarding the ICH: Amanda Roache, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 1176, Silver Spring, MD 20993–0002, Amanda.roache@ fda.hhs.gov, 301–796–4548. SUPPLEMENTARY INFORMATION: VerDate Sep<11>2014 16:52 Nov 21, 2016 Jkt 241001 I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Draft Guidance for Industry; Availability.’’ In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote international harmonization of regulatory requirements. FDA has participated in meetings designed to enhance harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and then reduce differences in clinical and scientific approaches for drug development among regulatory agencies. ICH was organized to provide an opportunity for harmonization initiatives to be developed with input from both regulatory and industry representatives. FDA also seeks input from consumer representatives and others. ICH is concerned with harmonization of technical requirements for the registration of pharmaceutical products for human use among regulators around the world. The six founding members of the ICH are the European Commission; the European Federation of Pharmaceutical Industries Associations; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; CDER and CBER, FDA; and the Pharmaceutical Research and Manufacturers of America. The Standing Members of the ICH Association include Health Canada and Swissmedic. Any party eligible as a Member in accordance with the ICH Articles of Association can apply for membership in writing to the ICH Secretariat. The ICH Secretariat, which coordinates the preparation of documentation, operates as an international nonprofit organization and is funded by the Members of the ICH Association. The ICH Assembly is the overarching body of the Association and includes representatives from each of the ICH members and observers. In September 2016, the ICH Assembly endorsed the draft guidance entitled ‘‘E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population’’ and agreed that the guidance should be made available for public comment. The draft guidance is the product of the E11 Expert Working Group of the ICH. PO 00000 Frm 00052 Fmt 4703 Sfmt 9990 Comments about this draft will be considered by FDA and the E11 Expert Working Group. The addendum to the ICH E11 guidance complements the guidance and provides clarification and current regulatory perspective on current and evolving topics in global pediatric drug development. The E11(R1) addendum includes sections on ethical considerations; age classification and pediatric subgroups, including neonates; and pediatric formulations that supplement the content in the ICH E11 guidance. A new section on Commonality of Scientific Approach for Pediatric Drug Development Programs addresses issues to aid scientific discussions at various stages of pediatric drug development in different regions. The section on Approaches to Optimize Pediatric Drug Development provides additional information on extrapolation and introduces modelling and simulation. 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 ‘‘E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.’’ 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. Electronic Access Persons with access to the Internet may obtain the draft guidance at https:// www.regulations.gov, http:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, or http:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/Guidances/default.htm. Dated: November 16, 2016. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2016–28048 Filed 11–21–16; 8:45 am] BILLING CODE 4164–01–P E:\FR\FM\22NON1.SGM 22NON1

Agencies

[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)]
[Notices]
[Pages 83847-83848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-28048]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-D-3848]


E11(R1) Addendum: Clinical Investigation of Medicinal Products in 
the Pediatric Population; 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 entitled ``E11(R1) Addendum: 
Clinical Investigation of Medicinal Products in the Pediatric 
Population'' (E11(R1) addendum). The draft guidance was prepared under 
the auspices of the International Council for Harmonisation (ICH), 
formerly the International Conference on Harmonisation. The draft 
guidance is an addendum to the guidance entitled ``E11 Clinical 
Investigation of Medicinal Products in the Pediatric Population'' (ICH 
E11 guidance). The draft guidance is intended to update the ICH E11 
guidance and provide clarification and current regulatory perspective 
on topics in global pediatric drug development.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115 (g)(5)), to ensure that the Agency considers your comment on 
this draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by February 21, 2017.

ADDRESSES: You may submit comments 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): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, 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-2016-D-3848 for ``E11(R1) Addendum: Clinical Investigation of 
Medicinal Products in the Pediatric Population; International Council 
for Harmonisation; Draft Guidance for Industry; Availability.'' 
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 Division of Dockets Management between 9 
a.m. and 4 p.m., Monday through Friday.
     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 Division of Dockets Management. 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

[[Page 83848]]

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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    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 Division of Dockets Management, 5630 Fishers 
Lane, Rm. 1061, Rockville, MD 20852.
    Submit written requests for single copies of the draft guidance to 
the Division of Drug Information, Center for Drug Evaluation and 
Research (CDER), 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 draft 
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, Silver Spring, MD 20993-0002, 301-
796-2141; or CBER's Office of Communication, Outreach and Development; 
Center for Biologics Evaluation and Research; Food and Drug 
Administration; 10903 New Hampshire Ave., Bldg. 71; Silver Spring, MD 
20993-0002; ocod@fda.hhs.gov; 1-800-835-4709 or 240-402-8010.
    Regarding the ICH: Amanda Roache, Center for Drug Evaluation and 
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, Rm. 1176, Silver Spring, MD 20993-0002, Amanda.roache@fda.hhs.gov, 
301-796-4548.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal 
Products in the Pediatric Population; International Council for 
Harmonisation; Draft Guidance for Industry; Availability.'' In recent 
years, many important initiatives have been undertaken by regulatory 
authorities and industry associations to promote international 
harmonization of regulatory requirements. FDA has participated in 
meetings designed to enhance harmonization and is committed to seeking 
scientifically based harmonized technical procedures for pharmaceutical 
development. One of the goals of harmonization is to identify and then 
reduce differences in clinical and scientific approaches for drug 
development among regulatory agencies.
    ICH was organized to provide an opportunity for harmonization 
initiatives to be developed with input from both regulatory and 
industry representatives. FDA also seeks input from consumer 
representatives and others. ICH is concerned with harmonization of 
technical requirements for the registration of pharmaceutical products 
for human use among regulators around the world. The six founding 
members of the ICH are the European Commission; the European Federation 
of Pharmaceutical Industries Associations; the Japanese Ministry of 
Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers 
Association; CDER and CBER, FDA; and the Pharmaceutical Research and 
Manufacturers of America. The Standing Members of the ICH Association 
include Health Canada and Swissmedic. Any party eligible as a Member in 
accordance with the ICH Articles of Association can apply for 
membership in writing to the ICH Secretariat. The ICH Secretariat, 
which coordinates the preparation of documentation, operates as an 
international nonprofit organization and is funded by the Members of 
the ICH Association.
    The ICH Assembly is the overarching body of the Association and 
includes representatives from each of the ICH members and observers.
    In September 2016, the ICH Assembly endorsed the draft guidance 
entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal 
Products in the Pediatric Population'' and agreed that the guidance 
should be made available for public comment. The draft guidance is the 
product of the E11 Expert Working Group of the ICH. Comments about this 
draft will be considered by FDA and the E11 Expert Working Group.
    The addendum to the ICH E11 guidance complements the guidance and 
provides clarification and current regulatory perspective on current 
and evolving topics in global pediatric drug development. The E11(R1) 
addendum includes sections on ethical considerations; age 
classification and pediatric subgroups, including neonates; and 
pediatric formulations that supplement the content in the ICH E11 
guidance. A new section on Commonality of Scientific Approach for 
Pediatric Drug Development Programs addresses issues to aid scientific 
discussions at various stages of pediatric drug development in 
different regions. The section on Approaches to Optimize Pediatric Drug 
Development provides additional information on extrapolation and 
introduces modelling and simulation.
    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 ``E11(R1) 
Addendum: Clinical Investigation of Medicinal Products in the Pediatric 
Population.'' 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. Electronic Access

    Persons with access to the Internet may obtain the draft guidance 
at https://www.regulations.gov, http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or 
http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.

    Dated: November 16, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-28048 Filed 11-21-16; 8:45 am]
 BILLING CODE 4164-01-P