83 FR 15581 - E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population; International Council for Harmonisation; Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 70 (April 11, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 70 (April 11, 2018)
| Page Range | 15581-15583 | |
| FR Document | 2018-07375 |
[Federal Register Volume 83, Number 70 (Wednesday, April 11, 2018)] [Notices] [Pages 15581-15583] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07375] ----------------------------------------------------------------------- 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; 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 guidance for industry entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population'' (E11(R1) addendum or addendum). The guidance was prepared under the auspices of the International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation. The guidance is an addendum to the guidance published in 2000 entitled ``E11 Clinical Investigation of Medicinal Products in the Pediatric Population'' (ICH E11 (2000)), and provides updates to the original guidance. This addendum does not alter the scope of the original guidance, which outlines an approach to the safe, efficient, and ethical study of medicinal products in the pediatric population. This addendum complements and provides clarification and current regulatory perspective on topics in pediatric drug development. The guidance is intended to provide high-level guidance on the implementation of important approaches in pediatric drug development. This harmonized addendum will help to define the current recommendations and reduce the likelihood that substantial differences will exist among regions for the acceptance of data generated in pediatric global drug development programs and ensure timely access to medicines for children. DATES: The announcement of the guidance is published in the Federal Register on April 11, 2018. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: Electronic Submissions Submit electronic comments in the following way:Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on https://www.regulations.gov. If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see ``Written/Paper Submissions'' and ``Instructions''). Written/Paper Submissions Submit written/paper submissions as follows: Mail/Hand delivery/Courier (for written/paper submissions): Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in ``Instructions.'' Instructions: All submissions received must include the Docket No. FDA-2016-D-3848 for ``E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.'' Received comments will be placed in the docket and, except for those [[Page 15582]] 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. 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.thefederalregister.org/fdsys/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. You may submit comments on any guidance at any time (see 21 CFR 10.115(g)(5)). Submit written requests for single copies of this 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, 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 guidance document. FOR FURTHER INFORMATION CONTACT: Regarding the guidance: Lynne Yao, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 22, Rm. 6406, Silver Spring, MD 20993-0002, 301-796-2141; 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: 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, 301-796-4548. SUPPLEMENTARY INFORMATION: I. Background In recent years, regulatory authorities and industry associations from around the world have participated in many important initiatives to promote international harmonization of regulatory requirements under the ICH. FDA has participated in several ICH meetings designed to enhance harmonization, and FDA is committed to seeking scientifically- based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify and reduce differences in technical requirements for drug development among regulatory agencies. The ICH was established 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. The 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; FDA; the Japanese Ministry of Health, Labour, and Welfare; the Japanese Pharmaceutical Manufacturers Association; 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. The Assembly is responsible for the endorsement of draft guidelines and adoption of final guidelines. FDA publishes ICH guidelines as FDA guidances. In the Federal Register of November 22, 2016 (81 FR 83847), FDA published a notice announcing the availability of a draft guidance entitled ``E11(R1) Addendum: Clinical Investigation of Medicinal Products in the Pediatric Population.'' The notice gave interested persons an opportunity to submit comments by February 21, 2017. After consideration of the comments received and revisions to the guideline, a final draft of the guideline was submitted to the ICH Assembly and endorsed by the regulatory agencies in August 2017. The E11(R1) addendum provides guidance on pediatric drug development and is intended to complement and provide clarification and current regulatory perspectives on topics in pediatric drug development that were originally presented in ICH E11 (2000). The addendum does not alter the scope of the original guidance, which outlines an approach to the safe, efficient, and ethical study of medicinal products in the pediatric population. In the addendum, section II (2) (ETHICAL CONSIDERATIONS), section IV (4) (AGE CLASSIFICATION AND PEDIATRIC SUBGROUPS, INCLUDING NEONATES), and section VII (7) (PEDIATRIC FORMULATIONS), supplement the content in ICH E11 (2000). Section III (3) (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. Section V (5) (APPROACHES TO OPTIMIZE PEDIATRIC DRUG DEVELOPMENT) includes enhancement to the topic of Extrapolation, and introduces Modeling and Simulation. Section VI (6) (PRACTICALITIES IN THE DESIGN AND EXECUTION OF PEDIATRIC CLINICAL TRIALS) includes discussion of feasibility, outcome assessments, and long-term clinical aspects, including [[Page 15583]] safety. These sections describe essential considerations intended to provide high-level guidance on the implementation of these approaches in pediatric drug development and have been revised based on comments received from global stakeholders. This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents 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. This guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the guidance at https://www.regulations.gov, https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm, or https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm. Dated: April 4, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07375 Filed 4-10-18; 8:45 am] BILLING CODE 4164-01-P
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health branches of Federal, State, and participating in the selection process the likelihood that substantial
local governments also may participate with the opportunity to vote on the differences will exist among regions for
in the selection process. Any consumer listed nominees. Only organizations the acceptance of data generated in
organization interested in participating vote in the selection process. Persons pediatric global drug development
in the selection of an appropriate voting who nominate themselves to serve as programs and ensure timely access to
or nonvoting member to represent voting or nonvoting consumer medicines for children.
consumer interests should send a letter representatives will not participate in DATES: The announcement of the
stating that interest to FDA (see the selection process. guidance is published in the Federal
ADDRESSES) within 30 days of This notice is issued under the Register on April 11, 2018.
publication of this document. Federal Advisory Committee Act (5 ADDRESSES: You may submit either
Within the subsequent 30 days, FDA U.S.C. app. 2) and 21 CFR part 14,
will compile a list of consumer electronic or written comments on
relating to advisory committees. Agency guidances at any time as
organizations that will participate in the
Dated: April 5, 2018. follows:
selection process and will forward to
each such organization a ballot listing at Leslie Kux,
Electronic Submissions
least two qualified nominees selected by Associate Commissioner for Policy.
[FR Doc. 2018–07426 Filed 4–10–18; 8:45 am] Submit electronic comments in the
the Agency based on the nominations
following way:
received, together with each nominee’s BILLING CODE 4164–01–P
current curriculum vitae or resume. • Federal eRulemaking Portal:
Ballots must be filled out and returned https://www.regulations.gov. Follow the
to FDA within 30 days. The nominee DEPARTMENT OF HEALTH AND instructions for submitting comments.
receiving the highest number of votes HUMAN SERVICES Comments submitted electronically,
ordinarily will be selected to serve as including attachments, to https://
the member representing consumer Food and Drug Administration www.regulations.gov will be posted to
interests for that particular advisory the docket unchanged. Because your
[Docket No. FDA–2016–D–3848]
committee or panel. comment will be made public, you are
E11(R1) Addendum: Clinical solely responsible for ensuring that your
IV. Nomination Procedures comment does not include any
Investigation of Medicinal Products in
Any interested person or organization the Pediatric Population; International confidential information that you or a
may nominate one or more qualified Council for Harmonisation; Guidance third party may not wish to be posted,
persons to represent consumer interests for Industry; Availability such as medical information, your or
on the Agency’s advisory committees or anyone else’s Social Security number, or
panels. Self-nominations are also AGENCY: Food and Drug Administration, confidential business information, such
accepted. Nominations must include a HHS. as a manufacturing process. Please note
current, complete résumé or curriculum ACTION: Notice of availability. that if you include your name, contact
vitae for each nominee and a signed information, or other information that
copy of the Acknowledgement and SUMMARY: The Food and Drug identifies you in the body of your
Consent form available at the FDA Administration (FDA or Agency) is comments, that information will be
Advisory Nomination Portal (see announcing the availability of a posted on https://www.regulations.gov.
ADDRESSES section of this document), guidance for industry entitled ‘‘E11(R1) • If you want to submit a comment
and a list of consumer or community- Addendum: Clinical Investigation of with confidential information that you
based organizations for which the Medicinal Products in the Pediatric do not wish to be made available to the
candidate can demonstrate active Population’’ (E11(R1) addendum or public, submit the comment as a
participation. addendum). The guidance was prepared written/paper submission and in the
Nominations must also specify the under the auspices of the International manner detailed (see ‘‘Written/Paper
advisory committee(s) or panel(s) for Council for Harmonisation (ICH), Submissions’’ and ‘‘Instructions’’).
which the nominee is recommended. In formerly the International Conference
on Harmonisation. The guidance is an Written/Paper Submissions
addition, nominations must also
acknowledge that the nominee is aware addendum to the guidance published in Submit written/paper submissions as
of the nomination unless self- 2000 entitled ‘‘E11 Clinical follows:
nominated. FDA will ask potential Investigation of Medicinal Products in • Mail/Hand delivery/Courier (for
candidates to provide detailed the Pediatric Population’’ (ICH E11 written/paper submissions): Dockets
information concerning such matters as (2000)), and provides updates to the Management Staff (HFA–305), Food and
financial holdings, employment, and original guidance. This addendum does Drug Administration, 5630 Fishers
research grants and/or contracts to not alter the scope of the original Lane, Rm. 1061, Rockville, MD 20852.
permit evaluation of possible sources of guidance, which outlines an approach • For written/paper comments
conflicts of interest. Members will be to the safe, efficient, and ethical study submitted to the Dockets Management
invited to serve for terms up to 4 years. of medicinal products in the pediatric Staff, FDA will post your comment, as
FDA will review all nominations population. This addendum well as any attachments, except for
received within the specified complements and provides clarification information submitted, marked and
timeframes and prepare a ballot and current regulatory perspective on identified, as confidential, if submitted
containing the names of qualified topics in pediatric drug development. as detailed in ‘‘Instructions.’’
amozie on DSK30RV082PROD with NOTICES
nominees. Names not selected will The guidance is intended to provide Instructions: All submissions received
remain on a list of eligible nominees high-level guidance on the must include the Docket No. FDA–
and be reviewed periodically by FDA to implementation of important 2016–D–3848 for ‘‘E11(R1) Addendum:
determine continued interest. Upon approaches in pediatric drug Clinical Investigation of Medicinal
selecting qualified nominees for the development. This harmonized Products in the Pediatric Population.’’
ballot, FDA will provide those addendum will help to define the Received comments will be placed in
consumer organizations that are current recommendations and reduce the docket and, except for those
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![Federal Register / Vol. 83, No. 70 / Wednesday, April 11, 2018 / Notices 15583
safety. These sections describe essential provisions set forth in sections DEPARTMENT OF HEALTH AND
considerations intended to provide 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., HUMAN SERVICES
high-level guidance on the as amended. The grant applications and
implementation of these approaches in the discussions could disclose National Institutes of Health
pediatric drug development and have confidential trade secrets or commercial
been revised based on comments property such as patentable material, National Cancer Institute; Notice of
received from global stakeholders. and personal information concerning Meeting
This guidance is being issued individuals associated with the grant Pursuant to section 10(a) of the
consistent with FDA’s good guidance applications, the disclosure of which Federal Advisory Committee Act, as
practices regulation (21 CFR 10.115). would constitute a clearly unwarranted amended, notice is hereby given of a
The guidance represents the current invasion of personal privacy. meeting of the Frederick National
thinking of FDA on ‘‘E11(R1) Laboratory Advisory Committee to the
Name of Comittee: National Advisory
Addendum: Clinical Investigation of General Medical Sciences Council. National Cancer Institute.
Medicinal Products in the Pediatric Date: May 24–25, 2018. The meeting will be open to the
Population.’’ It does not establish any Closed: May 24, 2018, 9:00 a.m. to 5:00 public, with attendance limited to space
rights for any person and is not binding p.m. available. Individuals who plan to
on FDA or the public. You can use an Agenda: To review and evaluate grant attend and need special assistance, such
alternative approach if it satisfies the applications. as sign language interpretation or other
requirements of the applicable statutes Place: National Institutes of Health, reasonable accommodations, should
and regulations. This guidance is not Natcher Building, Conference Rooms E1 & notify the Contact Person listed below
subject to Executive Order 12866. E2, 45 Center Drive, Bethesda, MD 20892. in advance of the meeting. The meeting
II. Electronic Access Open: May 25, 2018, 8:30 a.m. to 12:00 will also be videocast and can be
p.m. accessed from the NIH Videocasting and
Persons with access to the internet Agenda: For the discussion of program Podcasting website (http://
may obtain the guidance at https:// policies and issues; opening remarks; report videocast.nih.gov/).
www.regulations.gov, https:// of the Director, NIGMS; and other business
www.fda.gov/Drugs/ Name of Committee: Frederick National
of the Council. Laboratory Advisory Committee to the
GuidanceComplianceRegulatory Place: National Institutes of Health, National Cancer Institute.
Information/Guidances/default.htm, or Natcher Building, Conference Rooms E1 & Date: May 8, 2018.
https://www.fda.gov/BiologicsBlood E2, 45 Center Drive, Bethesda, MD 20892. Time: 9:00 a.m. to 5:00 p.m.
Vaccines/GuidanceCompliance Contact Person: Ann A. Hagan, Ph.D., Agenda: Ongoing and new activities at the
RegulatoryInformation/Guidances/ Associate Director for Extramural Activities, Frederick National Laboratory for Cancer
default.htm. NIGMS, NIH, DHHS, 45 Center Drive, Room Research.
2AN24H, MSC 6200, Bethesda, MD 20892– Place: National Cancer Institute Shady
Dated: April 4, 2018. Grove, 9609 Medical Center Drive,
Leslie Kux, 6200, (301) 594–4499, hagana@
Conference Room TE406, Rockville, MD
nigms.nih.gov. 20850.
Associate Commissioner for Policy.
Any interested person may file written Contact Person: Caron A. Lyman, Ph.D.,
[FR Doc. 2018–07375 Filed 4–10–18; 8:45 am]
comments with the committee by forwarding Executive Secretary, National Cancer
BILLING CODE 4164–01–P Institute, National Institutes of Health, 9609
the statement to the Contact Person listed on
this notice. The statement should include the Medical Center Drive, Room 7W–126,
name, address, telephone number and when Bethesda, MD 20892, 240–276–6348,
DEPARTMENT OF HEALTH AND lymanc@mail.nih.gov.
applicable, the business or professional
HUMAN SERVICES affiliation of the interested person. Any interested person may file written
In the interest of security, NIH has comments with the committee by forwarding
National Institutes of Health the statement to the Contact Person listed on
instituted stringent procedures for entrance
this notice. The statement should include the
National Institute of General Medical onto the NIH campus. All visitor vehicles, name, address, telephone number and when
Sciences; Notice of Meeting including taxicabs, hotel, and airport shuttles applicable, the business or professional
will be inspected before being allowed on affiliation of the interested person.
Pursuant to section 10(d) of the campus. Visitors will be asked to show one In the interest of security, NCI Shady Grove
Federal Advisory Committee Act, as form of identification (for example, a has instituted stringent procedures for
amended, notice is hereby given of a government-issued photo ID, driver’s license, entrance into the NCI Shady Grove building.
meeting of the National Advisory or passport) and to state the purpose of their Visitors will be asked to show one form of
General Medical Sciences Council. visit. identification (for example, a government-
The meeting will be open to the Information is also available on the issued photo ID, driver’s license, or passport)
and to state the purpose of their visit.
public as indicated below, with a short Institute’s/Center’s home page: http://
Information is also available on the
public comment period at the end. www.nigms.nih.gov/About/Council, where an Institute’s/Center’s home page: http://
Attendance is limited by the space agenda and any additional information for deainfo.nci.nih.gov/advisory/fac/fac.htm,
available. Individuals who plan to the meeting will be posted when available. where an agenda and any additional
attend and need special assistance, such (Catalogue of Federal Domestic Assistance information for the meeting will be posted
as sign language interpretation or other Program Nos. 93.859, Biomedical Research when available.
reasonable accommodations, should and Research Training, National Institutes of (Catalogue of Federal Domestic Assistance
notify the Contact Person listed below Health, HHS) Program Nos. 93.392, Cancer Construction;
amozie on DSK30RV082PROD with NOTICES
in advance of the meeting. The open 93.393, Cancer Cause and Prevention
Dated: April 5, 2018. Research; 93.394, Cancer Detection and
session will also be videocast and can
Melanie J. Pantoja, Diagnosis Research; 93.395, Cancer
be accessed from the NIH Videocasting Treatment Research; 93.396, Cancer Biology
and Podcasting website (http:// Program Analyst, Office of Federal Advisory
Committee Policy. Research; 93.397, Cancer Centers Support;
videocast.nih.gov). 93.398, Cancer Research Manpower; 93.399,
The meeting will be closed to the [FR Doc. 2018–07396 Filed 4–10–18; 8:45 am] Cancer Control, National Institutes of Health,
public in accordance with the BILLING CODE 4140–01–P HHS)
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Document Created: 2018-04-10 23:59:11
Document Modified: 2018-04-10 23:59:11
| 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 | The announcement of the guidance is published in the Federal Register on April 11, 2018. | |
| Contact | Regarding the guidance: Lynne Yao, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Avenue, Bldg. 22, Rm. 6406, Silver Spring, MD 20993-0002, 301-796-2141; 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: 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, 301-796-4548. | |
| FR Citation | 83 FR 15581 |
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