83 FR 7057 - Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy From Adults to Pediatric Patients 4 Years of Age and Older; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 33 (February 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 33 (February 16, 2018)
| Page Range | 7057-7058 | |
| FR Document | 2018-03223 |
[Federal Register Volume 83, Number 33 (Friday, February 16, 2018)] [Notices] [Pages 7057-7058] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-03223] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-0178] Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy From Adults to Pediatric Patients 4 Years of Age and Older; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older.'' The draft guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of partial onset seizures (POS) in pediatric patients. Specifically, it addresses FDA's thinking regarding clinical development programs that can support extrapolation of evidence of effectiveness in treatment of POS in adults to pediatric patients 4 years of age and older. DATES: Submit either electronic or written comments on the draft guidance by April 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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 [[Page 7058]] 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-2018-D-0178 for ``Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older; Draft Guidance for Industry.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday. 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 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. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Billy Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-2250. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy from Adults to Pediatric Patients 4 Years of Age and Older.'' The draft guidance provides recommendations to sponsors on the clinical development of drugs for the treatment of POS in pediatric patients. Specifically, it addresses FDA's thinking regarding clinical development programs that can support extrapolation of evidence of effectiveness in treatment of POS in adults to pediatric patients 4 years of age and older. This draft guidance explains how efficacy can be extrapolated from adults to children when it is reasonable to assume that children, compared with adults, have a similar progression of disease, similar response of the disease to treatment, and similar exposure-response relationship. 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 ``Drugs for Treatment of Partial Onset Seizures: Full Extrapolation of Efficacy From Adults to Pediatric Patients 4 Years of Age and Older.'' 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 draft guidance at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or https://www.regulations.gov. Dated: February 12, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-03223 Filed 2-15-18; 8:45 am] BILLING CODE 4164-01-P
![Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices 7057
‘‘THIS DOCUMENT CONTAINS drugs for the acute treatment of DEPARTMENT OF HEALTH AND
CONFIDENTIAL INFORMATION.’’ The migraine. This guidance focuses on HUMAN SERVICES
Agency will review this copy, including specific drug development and trial
the claimed confidential information, in design issues that are unique to the Food and Drug Administration
its consideration of comments. The study of prescription drugs for the acute [Docket No. FDA–2018–D–0178]
second copy, which will have the treatment of migraine, including trial
claimed confidential information population, trial design, dose selection, Drugs for Treatment of Partial Onset
redacted/blacked out, will be available efficacy endpoints, and statistical Seizures: Full Extrapolation of Efficacy
for public viewing and posted on considerations. The guidance also From Adults to Pediatric Patients 4
https://www.regulations.gov. Submit discusses safety considerations, Years of Age and Older; Draft
both copies to the Dockets Management pediatric studies, and labeling Guidance for Industry; Availability
Staff. If you do not wish your name and considerations.
contact information to be made publicly AGENCY: Food and Drug Administration,
available, you can provide this This guidance finalizes the draft HHS.
information on the cover sheet and not guidance of the same name issued ACTION: Notice of availability.
in the body of your comments and you October 22, 2014 (79 FR 63129). It
SUMMARY: The Food and Drug
must identify this information as reflects FDA’s consideration of public Administration (FDA or Agency) is
‘‘confidential.’’ Any information marked comments on the draft guidance and announcing the availability of a draft
as ‘‘confidential’’ will not be disclosed makes minor clarifying changes. guidance for industry entitled ‘‘Drugs
except in accordance with 21 CFR 10.20 This guidance is being issued for Treatment of Partial Onset Seizures:
and other applicable disclosure law. For consistent with FDA’s good guidance Full Extrapolation of Efficacy from
more information about FDA’s posting practices regulation (21 CFR 10.115). Adults to Pediatric Patients 4 Years of
of comments to public dockets, see 80 The guidance represents the current Age and Older.’’ The draft guidance
FR 56469, September 18, 2015, or access thinking of FDA on developing drugs for provides recommendations to sponsors
the information at: https://www.gpo.gov/ on the clinical development of drugs for
the acute treatment of migraine. It does
fdsys/pkg/FR-2015-09-18/pdf/2015- the treatment of partial onset seizures
not establish any rights for any person
23389.pdf. (POS) in pediatric patients. Specifically,
Docket: For access to the docket to and is not binding on FDA or the public.
You can use an alternative approach if it addresses FDA’s thinking regarding
read background documents or the clinical development programs that can
electronic and written/paper comments it satisfies the requirements of the
applicable statutes and regulations. This support extrapolation of evidence of
received, go to https:// effectiveness in treatment of POS in
www.regulations.gov and insert the guidance is not subject to Executive
adults to pediatric patients 4 years of
docket number, found in brackets in the Order 12866.
age and older.
heading of this document, into the II. Paperwork Reduction Act of 1995 DATES: Submit either electronic or
‘‘Search’’ box and follow the prompts
written comments on the draft guidance
and/or go to the Dockets Management This guidance refers to previously by April 17, 2018 to ensure that the
Staff, 5630 Fishers Lane, Rm. 1061, approved collections of information Agency considers your comment on this
Rockville, MD 20852. found in FDA regulations. These draft guidance before it begins work on
You may submit comments on any collections of information are subject to the final version of the guidance.
guidance at any time (see 21 CFR review by the Office of Management and ADDRESSES: You may submit comments
10.115(g)(5)). Budget (OMB) under the Paperwork
Submit written requests for single on any guidance at any time as follows:
Reduction Act of 1995 (44 U.S.C. 3501–
copies of this guidance to the Division 3520). The collections of information in Electronic Submissions
of Drug Information, Center for Drug Submit electronic comments in the
21 CFR parts 201, 312, and 314 have
Evaluation and Research, Food and following way:
been approved under OMB control
Drug Administration, 10001 New • Federal eRulemaking Portal:
numbers 0910–0572, 0910–0014, and
Hampshire Ave., Hillandale Building, https://www.regulations.gov. Follow the
4th Floor, Silver Spring, MD 20993– 0910–0001, respectively.
instructions for submitting comments.
0002. Send one self-addressed adhesive III. Electronic Access Comments submitted electronically,
label to assist that office in processing including attachments, to https://
your requests. See the SUPPLEMENTARY Persons with access to the internet
www.regulations.gov will be posted to
INFORMATION section for electronic may obtain the guidance at either the docket unchanged. Because your
access to the guidance document. https://www.fda.gov/Drugs/Guidance comment will be made public, you are
FOR FURTHER INFORMATION CONTACT: Eric ComplianceRegulatoryInformation/ solely responsible for ensuring that your
Bastings, Center for Drug Evaluation and Guidances/default.htm or https:// comment does not include any
Research, Food and Drug www.regulations.gov. confidential information that you or a
Administration, 10903 New Hampshire Dated: February 12, 2018. third party may not wish to be posted,
Ave., Bldg. 22, Rm. 4334, Silver Spring, Leslie Kux, such as medical information, your or
MD 20993–0002, 301–796–1039. anyone else’s Social Security number, or
Associate Commissioner for Policy.
SUPPLEMENTARY INFORMATION: confidential business information, such
[FR Doc. 2018–03224 Filed 2–15–18; 8:45 am]
as a manufacturing process. Please note
daltland on DSKBBV9HB2PROD with NOTICES
I. Background BILLING CODE 4164–01–P that if you include your name, contact
FDA is announcing the availability of information, or other information that
a guidance for industry entitled identifies you in the body of your
‘‘Migraine: Developing Drugs for Acute comments, that information will be
Treatment.’’ The purpose of this posted on https://www.regulations.gov.
guidance is to assist sponsors in the • If you want to submit a comment
clinical development of prescription with confidential information that you
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![7058 Federal Register / Vol. 83, No. 33 / Friday, February 16, 2018 / Notices
do not wish to be made available to the the information at: https://www.gpo.gov/ Seizures: Full Extrapolation of Efficacy
public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015- From Adults to Pediatric Patients 4
written/paper submission and in the 23389.pdf. Years of Age and Older.’’ It does not
manner detailed (see ‘‘Written/Paper Docket: For access to the docket to establish any rights for any person and
Submissions’’ and ‘‘Instructions’’). read background documents or the is not binding on FDA or the public.
electronic and written/paper comments You can use an alternative approach if
Written/Paper Submissions
received, go to https:// it satisfies the requirements of the
Submit written/paper submissions as www.regulations.gov and insert the applicable statutes and regulations. This
follows: docket number, found in brackets in the guidance is not subject to Executive
• Mail/Hand delivery/Courier (for heading of this document, into the Order 12866.
written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and II. Electronic Access
and/or go to the Dockets Management
Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061, Persons with access to the internet
Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852. may obtain the draft guidance at either
• For written/paper comments You may submit comments on any https://www.fda.gov/Drugs/Guidance
submitted to the Dockets Management guidance at any time (see 21 CFR ComplianceRegulatoryInformation/
Staff, FDA will post your comment, as 10.115(g)(5)). Guidances/default.htm or https://
well as any attachments, except for Submit written requests for single www.regulations.gov.
information submitted, marked and copies of the draft guidance to the
identified, as confidential, if submitted Dated: February 12, 2018.
Division of Drug Information, Center for Leslie Kux,
as detailed in ‘‘Instructions.’’
Drug Evaluation and Research, Food
Instructions: All submissions received Associate Commissioner for Policy.
and Drug Administration, 10001 New
must include the Docket No. FDA– [FR Doc. 2018–03223 Filed 2–15–18; 8:45 am]
2018–D–0178 for ‘‘Drugs for Treatment Hampshire Ave., Hillandale Building,
BILLING CODE 4164–01–P
of Partial Onset Seizures: Full 4th Floor, Silver Spring, MD 20993–
Extrapolation of Efficacy from Adults to 0002. Send one self-addressed adhesive
Pediatric Patients 4 Years of Age and label to assist that office in processing
DEPARTMENT OF HEALTH AND
Older; Draft Guidance for Industry.’’ your requests. See the SUPPLEMENTARY
HUMAN SERVICES
INFORMATION section for electronic
Received comments will be placed in
the docket and, except for those access to the draft guidance document. Food and Drug Administration
submitted as ‘‘Confidential FOR FURTHER INFORMATION CONTACT:
Submissions,’’ publicly viewable at Billy Dunn, Center for Drug Evaluation [Docket No. FDA–2017–N–6928]
https://www.regulations.gov or at the and Research, Food and Drug
Dockets Management Staff between 9 Administration, 10903 New Hampshire Pediatric Advisory Committee;
a.m. and 4 p.m., Monday through Ave., Bldg. 22, Rm. 4332, Silver Spring, Establishment of a Public Docket;
Friday. MD 20993–0002, 301–796–2250. Request for Comments; Amendment of
• Confidential Submissions—To SUPPLEMENTARY INFORMATION: Notice
submit a comment with confidential
information that you do not wish to be I. Background AGENCY: Food and Drug Administration,
made publicly available, submit your FDA is announcing the availability of HHS.
comments only as a written/paper a draft guidance for industry entitled ACTION: Notice.
submission. You should submit two ‘‘Drugs for Treatment of Partial Onset
copies total. One copy will include the Seizures: Full Extrapolation of Efficacy SUMMARY: The Food and Drug
information you claim to be confidential from Adults to Pediatric Patients 4 Administration (FDA) is announcing an
with a heading or cover note that states Years of Age and Older.’’ The draft amendment to the notice of meeting of
‘‘THIS DOCUMENT CONTAINS guidance provides recommendations to the Pediatric Advisory Committee
CONFIDENTIAL INFORMATION.’’ The sponsors on the clinical development of (PAC). This meeting was announced in
Agency will review this copy, including drugs for the treatment of POS in the Federal Register of January 2, 2018.
the claimed confidential information, in pediatric patients. Specifically, it The amendment is being made to reflect
its consideration of comments. The addresses FDA’s thinking regarding a change in the Center for Devices and
second copy, which will have the clinical development programs that can Radiological Health (CDRH) products
claimed confidential information support extrapolation of evidence of portion of the document and to include
redacted/blacked out, will be available effectiveness in treatment of POS in the topics that will be discussed during
for public viewing and posted on adults to pediatric patients 4 years of the meeting. There are no other changes.
https://www.regulations.gov. Submit age and older. FOR FURTHER INFORMATION CONTACT:
both copies to the Dockets Management This draft guidance explains how Marieann Brill, Office of the
Staff. If you do not wish your name and efficacy can be extrapolated from adults Commissioner, Food and Drug
contact information to be made publicly to children when it is reasonable to Administration, 10903 New Hampshire
available, you can provide this assume that children, compared with Ave., Bldg. 32, Rm. 5154, Silver Spring,
information on the cover sheet and not adults, have a similar progression of MD 20993, 240–402–3838,
in the body of your comments and you disease, similar response of the disease marieann.brill@fda.hhs.gov, or FDA
must identify this information as to treatment, and similar exposure- Advisory Committee Information Line,
daltland on DSKBBV9HB2PROD with NOTICES
‘‘confidential.’’ Any information marked response relationship. 1–800–741–8138 (301–443–0572 in the
as ‘‘confidential’’ will not be disclosed This draft guidance is being issued Washington, DC area). Please call the
except in accordance with 21 CFR 10.20 consistent with FDA’s good guidance Information Line for up-to-date
and other applicable disclosure law. For practices regulation (21 CFR 10.115). information on this meeting.
more information about FDA’s posting The draft guidance, when finalized, will SUPPLEMENTARY INFORMATION: In the
of comments to public dockets, see 80 represent the current thinking of FDA Federal Register of January 2, 2018 (83
FR 56469, September 18, 2015, or access on ‘‘Drugs for Treatment of Partial Onset FR 125), FDA announced that a meeting
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Document Created: 2018-02-16 00:55:25
Document Modified: 2018-02-16 00:55:25
| 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 | Submit either electronic or written comments on the draft guidance by April 17, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance. | |
| Contact | Billy Dunn, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 4332, Silver Spring, MD 20993-0002, 301-796-2250. | |
| FR Citation | 83 FR 7057 |
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