81 FR 83847 - E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 81, Issue 225 (November 22, 2016)
Food and Drug Administration
Federal Register Volume 81, Issue 225 (November 22, 2016)
| Page Range | 83847-83848 | |
| FR Document | 2016-28048 |
[Federal Register Volume 81, Number 225 (Tuesday, November 22, 2016)] [Notices] [Pages 83847-83848] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2016-28048] ----------------------------------------------------------------------- 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Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population'' (E11(R1) addendum). The draft guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The draft guidance is an addendum to the guidance entitled ``E11 Clinical Investigation of Medicinal Products in the Pediatric Population'' (ICH E11 guidance). The draft guidance is intended to update the ICH E11 guidance and provide clarification and current regulatory perspective on topics in global pediatric drug development.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on any guidance at any time (see 21 CFR 10.115 (g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by February 21, 2017.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; [email protected]; 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, [email protected], 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
![Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices 83847
phase of the regulatory review period, DEPARTMENT OF HEALTH AND information, or other information that
while 780 days occurred during the HUMAN SERVICES identifies you in the body of your
approval phase. These periods of time comments, that information will be
were derived from the following dates: Food and Drug Administration posted on https://www.regulations.gov.
• If you want to submit a comment
1. The date an exemption under [Docket No. FDA–2016–D–3848]
with confidential information that you
section 505(i) of the Federal Food, Drug,
E11(R1) Addendum: Clinical do not wish to be made available to the
and Cosmetic Act (21 U.S.C. 355(i))
Investigation of Medicinal Products in public, submit the comment as a
became effective: October 15, 2003. FDA
the Pediatric Population; International written/paper submission and in the
has verified the applicant’s claim that manner detailed (see ‘‘Written/Paper
the date the investigational new drug Council for Harmonisation; Draft
Guidance for Industry; Availability Submissions’’ and ‘‘Instructions’’).
application became effective was on
October 15, 2003. Written/Paper Submissions
AGENCY: Food and Drug Administration,
2. The date the application was HHS. Submit written/paper submissions as
initially submitted with respect to the ACTION: Notice of availability. follows:
human biological product under section • Mail/Hand delivery/Courier (for
351 of the Public Health Service Act (42 SUMMARY: The Food and Drug written/paper submissions): Division of
U.S.C. 262): March 18, 2013. FDA has Administration (FDA or Agency) is Dockets Management (HFA–305), Food
verified the applicant’s claim that the announcing the availability of a draft and Drug Administration, 5630 Fishers
biologics license application (BLA) for guidance entitled ‘‘E11(R1) Addendum: Lane, Rm. 1061, Rockville, MD 20852.
ANAVIP (BLA 125488/0) was initially Clinical Investigation of Medicinal • For written/paper comments
submitted on March 18, 2013. Products in the Pediatric Population’’ submitted to the Division of Dockets
(E11(R1) addendum). The draft Management, FDA will post your
3. The date the application was comment, as well as any attachments,
approved: May 6, 2015. FDA has guidance was prepared under the
auspices of the International Council for except for information submitted,
verified the applicant’s claim that BLA marked and identified, as confidential,
Harmonisation (ICH), formerly the
125488/0 was approved on May 6, 2015. if submitted as detailed in
International Conference on
This determination of the regulatory Harmonisation. The draft guidance is an ‘‘Instructions.’’
review period establishes the maximum addendum to the guidance entitled ‘‘E11 Instructions: All submissions received
potential length of a patent extension. Clinical Investigation of Medicinal must include the Docket No. FDA–
However, the USPTO applies several Products in the Pediatric Population’’ 2016–D–3848 for ‘‘E11(R1) Addendum:
statutory limitations in its calculations (ICH E11 guidance). The draft guidance Clinical Investigation of Medicinal
of the actual period for patent extension. is intended to update the ICH E11 Products in the Pediatric Population;
In its application for patent extension, guidance and provide clarification and International Council for
this applicant seeks 5 years of patent current regulatory perspective on topics Harmonisation; Draft Guidance for
term extension. in global pediatric drug development. Industry; Availability.’’ Received
comments will be placed in the docket
III. Petitions DATES: Although you can comment on
and, except for those submitted as
any guidance at any time (see 21 CFR ‘‘Confidential Submissions,’’ publicly
Anyone with knowledge that any of 10.115 (g)(5)), to ensure that the Agency viewable at https://www.regulations.gov
the dates as published are incorrect may considers your comment on this draft or at the Division of Dockets
submit either electronic or written guidance before it begins work on the Management between 9 a.m. and 4 p.m.,
comments and ask for a redetermination final version of the guidance, submit Monday through Friday.
(see DATES). Furthermore, any interested either electronic or written comments • Confidential Submissions—To
person may petition FDA for a on the draft guidance by February 21, submit a comment with confidential
determination regarding whether the 2017. information that you do not wish to be
applicant for extension acted with due ADDRESSES: You may submit comments made publicly available, submit your
diligence during the regulatory review as follows: comments only as a written/paper
period. To meet its burden, the petition submission. You should submit two
must be timely (see DATES) and contain Electronic Submissions copies total. One copy will include the
sufficient facts to merit an FDA Submit electronic comments in the information you claim to be confidential
investigation. (See H. Rept. 857, part 1, following way: with a heading or cover note that states
98th Cong., 2d sess., pp. 41–42, 1984.) • Federal eRulemaking Portal: ‘‘THIS DOCUMENT CONTAINS
Petitions should be in the format https://www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The
specified in 21 CFR 10.30. instructions for submitting comments. Agency will review this copy, including
Submit petitions electronically to Comments submitted electronically, the claimed confidential information, in
https://www.regulations.gov at Docket including attachments, to https:// its consideration of comments. The
No. FDA–2013–S–0610. Submit written www.regulations.gov will be posted to second copy, which will have the
petitions (two copies are required) to the the docket unchanged. Because your claimed confidential information
Division of Dockets Management (HFA– comment will be made public, you are redacted/blacked out, will be available
305), Food and Drug Administration, solely responsible for ensuring that your for public viewing and posted on
5630 Fishers Lane, Rm. 1061, Rockville, comment does not include any https://www.regulations.gov. Submit
sradovich on DSK3GMQ082PROD with NOTICES
MD 20852. confidential information that you or a both copies to the Division of Dockets
Dated: November 16, 2016. third party may not wish to be posted, Management. If you do not wish your
such as medical information, your or name and contact information to be
Leslie Kux,
anyone else’s Social Security number, or made publicly available, you can
Associate Commissioner for Policy. confidential business information, such provide this information on the cover
[FR Doc. 2016–28049 Filed 11–21–16; 8:45 am] as a manufacturing process. Please note sheet and not in the body of your
BILLING CODE 4164–01–P that if you include your name, contact comments and you must identify this
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![83848 Federal Register / Vol. 81, No. 225 / Tuesday, November 22, 2016 / Notices
information as ‘‘confidential.’’ Any I. Background Comments about this draft will be
information marked as ‘‘confidential’’ FDA is announcing the availability of considered by FDA and the E11 Expert
will not be disclosed except in a draft guidance for industry entitled Working Group.
accordance with 21 CFR 10.20 and other ‘‘E11(R1) Addendum: Clinical The addendum to the ICH E11
applicable disclosure law. For more Investigation of Medicinal Products in guidance complements the guidance
information about FDA’s posting of the Pediatric Population; International and provides clarification and current
comments to public dockets, see 80 FR Council for Harmonisation; Draft regulatory perspective on current and
56469, September 18, 2015, or access Guidance for Industry; Availability.’’ In evolving topics in global pediatric drug
the information at: http://www.fda.gov/ recent years, many important initiatives development. The E11(R1) addendum
regulatoryinformation/dockets/ have been undertaken by regulatory includes sections on ethical
default.htm. authorities and industry associations to considerations; age classification and
Docket: For access to the docket to promote international harmonization of pediatric subgroups, including
read background documents or the regulatory requirements. FDA has neonates; and pediatric formulations
electronic and written/paper comments participated in meetings designed to
that supplement the content in the ICH
received, go to https:// enhance harmonization and is
E11 guidance. A new section on
www.regulations.gov and insert the committed to seeking scientifically
Commonality of Scientific Approach for
docket number, found in brackets in the based harmonized technical procedures
for pharmaceutical development. One of Pediatric Drug Development Programs
heading of this document, into the
the goals of harmonization is to identify addresses issues to aid scientific
‘‘Search’’ box and follow the prompts
and then reduce differences in clinical discussions at various stages of pediatric
and/or go to the Division of Dockets
and scientific approaches for drug drug development in different regions.
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. development among regulatory The section on Approaches to Optimize
agencies. Pediatric Drug Development provides
Submit written requests for single additional information on extrapolation
ICH was organized to provide an
copies of the draft guidance to the and introduces modelling and
opportunity for harmonization
Division of Drug Information, Center for simulation.
initiatives to be developed with input
Drug Evaluation and Research (CDER),
from both regulatory and industry This draft guidance is being issued
Food and Drug Administration, 10001
representatives. FDA also seeks input consistent with FDA’s good guidance
New Hampshire Ave., Hillandale
from consumer representatives and practices regulation (21 CFR 10.115).
Building, 4th Floor, Silver Spring, MD
others. ICH is concerned with The draft guidance, when finalized, will
20993–0002, or the Office of
harmonization of technical represent the current thinking of FDA
Communication, Outreach and
requirements for the registration of
Development, Center for Biologics on ‘‘E11(R1) Addendum: Clinical
pharmaceutical products for human use
Evaluation and Research (CBER), Food Investigation of Medicinal Products in
among regulators around the world. The
and Drug Administration, 10903 New the Pediatric Population.’’ It does not
six founding members of the ICH are the
Hampshire Ave., Bldg. 71, Rm. 3128, establish any rights for any person and
European Commission; the European
Silver Spring, MD 20993–0002. Send is not binding on FDA or the public.
Federation of Pharmaceutical Industries
one self-addressed adhesive label to You can use an alternative approach if
Associations; the Japanese Ministry of
assist that office in processing your it satisfies the requirements of the
Health, Labour, and Welfare; the
requests. The draft guidance may also be applicable statutes and regulations.
Japanese Pharmaceutical Manufacturers
obtained by mail by calling CBER at 1–
Association; CDER and CBER, FDA; and II. Electronic Access
800–835–4709 or 240–402–8010. See
the Pharmaceutical Research and
the SUPPLEMENTARY INFORMATION section
Manufacturers of America. The Persons with access to the Internet
for electronic access to the draft
Standing Members of the ICH may obtain the draft guidance at https://
guidance document.
Association include Health Canada and www.regulations.gov, http://
FOR FURTHER INFORMATION CONTACT: Swissmedic. Any party eligible as a www.fda.gov/Drugs/Guidance
Regarding the guidance: Lynne Yao, Member in accordance with the ICH ComplianceRegulatoryInformation/
Center for Drug Evaluation and Articles of Association can apply for Guidances/default.htm, or http://
Research, Food and Drug membership in writing to the ICH www.fda.gov/BiologicsBloodVaccines/
Administration, 10903 New Hampshire Secretariat. The ICH Secretariat, which GuidanceComplianceRegulatory
Ave., Bldg. 22, Silver Spring, MD coordinates the preparation of Information/Guidances/default.htm.
20993–0002, 301–796–2141; or CBER’s documentation, operates as an
Office of Communication, Outreach and international nonprofit organization and Dated: November 16, 2016.
Development; Center for Biologics is funded by the Members of the ICH Leslie Kux,
Evaluation and Research; Food and Association. Associate Commissioner for Policy.
Drug Administration; 10903 New The ICH Assembly is the overarching [FR Doc. 2016–28048 Filed 11–21–16; 8:45 am]
Hampshire Ave., Bldg. 71; Silver Spring, body of the Association and includes BILLING CODE 4164–01–P
MD 20993–0002; ocod@fda.hhs.gov; 1– representatives from each of the ICH
800–835–4709 or 240–402–8010. members and observers.
In September 2016, the ICH Assembly
Regarding the ICH: Amanda Roache,
endorsed the draft guidance entitled
sradovich on DSK3GMQ082PROD with NOTICES
Center for Drug Evaluation and
‘‘E11(R1) Addendum: Clinical
Research, Food and Drug
Investigation of Medicinal Products in
Administration, 10903 New Hampshire
the Pediatric Population’’ and agreed
Ave., Bldg. 51, Rm. 1176, Silver Spring,
that the guidance should be made
MD 20993–0002, Amanda.roache@
available for public comment. The draft
fda.hhs.gov, 301–796–4548.
guidance is the product of the E11
SUPPLEMENTARY INFORMATION: Expert Working Group of the ICH.
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Document Created: 2018-02-14 08:29:27
Document Modified: 2018-02-14 08:29:27
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice of availability. | |
| 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. | |
| 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; [email protected]; 1-800-835-4709 or 240-402-8010. | |
| FR Citation | 81 FR 83847 |
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