Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Draft Guidance for Industry; Availability, 25675-25676 [2018-11828]

Download as PDF Federal Register / Vol. 83, No. 107 / Monday, June 4, 2018 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–1540] Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ‘‘Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.’’ The purpose of this draft guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this draft guidance defined as ages 12 to 17) in relevant adult oncology clinical trials. The draft guidance focuses on appropriate criteria for inclusion in adult trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations, safety monitoring, and ethical requirements. DATES: Submit either electronic or written comments on the draft guidance by August 3, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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: sradovich on DSK3GMQ082PROD with NOTICES SUMMARY: Electronic Submissions Submit electronic comments in the following way: • Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, 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. VerDate Sep<11>2014 18:35 Jun 01, 2018 Jkt 244001 • 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– 2018–D–1540 for ‘‘Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.’’ 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 PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 25675 the information at: https://www.gpo.gov/ fdsys/pkg/FR-2015-09-18/pdf/201523389.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, or 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. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Meredith K. Chuk, Center for Drug Evaluation and Research, Food and Drug Administration, 5901–B Ammendale Rd., Beltsville, MD 20705– 1266, 301–796–2320; 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. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of a draft guidance for industry entitled ‘‘Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.’’ The purpose of this draft guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this draft guidance defined as ages 12 to 17) in relevant adult oncology clinical trials. The following topics are the focus of this guidance: (1) Appropriate criteria for inclusion in adult trials at various stages of drug development; (2) considerations for dosing and pharmacokinetic evaluations; (3) safety monitoring; and (4) ethical requirements. E:\FR\FM\04JNN1.SGM 04JNN1 25676 Federal Register / Vol. 83, No. 107 / Monday, June 4, 2018 / Notices 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 ‘‘Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.’’ 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 draft guidance is not subject to Executive Order 12866. II. Electronic Access Persons with access to the internet may obtain the draft guidance at https:// www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm, https:// www.fda.gov/BiologicsBloodVaccines/ GuidanceComplianceRegulatory Information/default.htm, or https:// www.regulations.gov. Dated: May 29, 2018. Leslie Kux, Associate Commissioner for Policy. [Docket ID FEMA–2018–0002; Internal Agency Docket No. FEMA–B–1831] Federal Emergency Management Agency Changes in Flood Hazard Determinations [Internal Agency Docket No. FEMA–4364– DR; Docket ID FEMA–2018–0001] North Carolina; Amendment No. 1 to Notice of a Major Disaster Declaration Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: This notice amends the notice of a major disaster declaration for the State of North Carolina (FEMA–4364– DR), dated May 8, 2018, and related determinations. DATE: The amendment was issued on May 17, 2018. FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and Recovery, Federal Emergency Management Agency, 500 C Street SW, Washington, DC 20472, (202) 646–2833. SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Glen Sachtleben, of FEMA is appointed to act as the Federal Coordinating Officer for this disaster. sradovich on DSK3GMQ082PROD with NOTICES Jkt 244001 [FR Doc. 2018–11874 Filed 6–1–18; 8:45 am] Federal Emergency Management Agency DEPARTMENT OF HOMELAND SECURITY 18:35 Jun 01, 2018 Brock Long, Administrator, Federal Emergency Management Agency. DEPARTMENT OF HOMELAND SECURITY BILLING CODE 4164–01–P VerDate Sep<11>2014 The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance— Disaster Housing Operations for Individuals and Households; 97.050, Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant. BILLING CODE 9111–23–P [FR Doc. 2018–11828 Filed 6–1–18; 8:45 am] SUMMARY: This action terminates the appointment of Elizabeth Turner as Federal Coordinating Officer for this disaster. Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: This notice lists communities where the addition or modification of Base Flood Elevations (BFEs), base flood depths, Special Flood Hazard Area (SFHA) boundaries or zone designations, or the regulatory floodway (hereinafter referred to as flood hazard determinations), as shown on the Flood Insurance Rate Maps (FIRMs), and where applicable, in the supporting Flood Insurance Study (FIS) reports, prepared by the Federal Emergency Management Agency (FEMA) for each community, is appropriate because of new scientific or technical data. The FIRM, and where applicable, portions of the FIS report, have been revised to reflect these flood hazard determinations through issuance of a Letter of Map Revision (LOMR), in accordance with Federal Regulations. The LOMR will be used by insurance agents and others to calculate appropriate flood insurance premium rates for new buildings and the contents SUMMARY: PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 of those buildings. For rating purposes, the currently effective community number is shown in the table below and must be used for all new policies and renewals. These flood hazard determinations will be finalized on the dates listed in the table below and revise the FIRM panels and FIS report in effect prior to this determination for the listed communities. From the date of the second publication of notification of these changes in a newspaper of local circulation, any person has 90 days in which to request through the community that the Deputy Associate Administrator for Insurance and Mitigation reconsider the changes. The flood hazard determination information may be changed during the 90-day period. DATES: The affected communities are listed in the table below. Revised flood hazard information for each community is available for inspection at both the online location and the respective community map repository address listed in the table below. Additionally, the current effective FIRM and FIS report for each community are accessible online through the FEMA Map Service Center at https:// msc.fema.gov for comparison. Submit comments and/or appeals to the Chief Executive Officer of the community as listed in the table below. FOR FURTHER INFORMATION CONTACT: Rick Sacbibit, Chief, Engineering Services Branch, Federal Insurance and Mitigation Administration, FEMA, 400 C Street SW, Washington, DC 20472 (202) 646–7659, or (email) patrick.sacbibit@fema.dhs.gov; or visit the FEMA Map Information eXchange (FMIX) online at https:// www.floodmaps.fema.gov/fhm/fmx_ main.html. ADDRESSES: The specific flood hazard determinations are not described for each community in this notice. However, the online location and local community map repository address where the flood hazard determination information is available for inspection is provided. Any request for reconsideration of flood hazard determinations must be submitted to the Chief Executive Officer of the community as listed in the table below. The modifications are made pursuant to section 201 of the Flood Disaster Protection Act of 1973, 42 U.S.C. 4105, and are in accordance with the National Flood Insurance Act of 1968, 42 U.S.C. 4001 et seq., and with 44 CFR part 65. SUPPLEMENTARY INFORMATION: E:\FR\FM\04JNN1.SGM 04JNN1

Agencies

[Federal Register Volume 83, Number 107 (Monday, June 4, 2018)]
[Notices]
[Pages 25675-25676]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-11828]



[[Page 25675]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-D-1540]


Considerations for the Inclusion of Adolescent Patients in Adult 
Oncology Clinical Trials; 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 
``Considerations for the Inclusion of Adolescent Patients in Adult 
Oncology Clinical Trials.'' The purpose of this draft guidance is to 
provide the pharmaceutical industry, clinical investigators, and 
institutional review boards with information to facilitate the 
inclusion of adolescent patients (for purposes of this draft guidance 
defined as ages 12 to 17) in relevant adult oncology clinical trials. 
The draft guidance focuses on appropriate criteria for inclusion in 
adult trials at various stages of drug development, considerations for 
dosing and pharmacokinetic evaluations, safety monitoring, and ethical 
requirements.

DATES: Submit either electronic or written comments on the draft 
guidance by August 3, 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 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-1540 for ``Considerations for the Inclusion of Adolescent 
Patients in Adult Oncology Clinical Trials.'' 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.gpo.gov/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, or 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. See the SUPPLEMENTARY INFORMATION section for electronic 
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Meredith K. Chuk, Center for Drug 
Evaluation and Research, Food and Drug Administration, 5901-B Ammendale 
Rd., Beltsville, MD 20705-1266, 301-796-2320; 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.

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a draft guidance for industry 
entitled ``Considerations for the Inclusion of Adolescent Patients in 
Adult Oncology Clinical Trials.'' The purpose of this draft guidance is 
to provide the pharmaceutical industry, clinical investigators, and 
institutional review boards with information to facilitate the 
inclusion of adolescent patients (for purposes of this draft guidance 
defined as ages 12 to 17) in relevant adult oncology clinical trials. 
The following topics are the focus of this guidance: (1) Appropriate 
criteria for inclusion in adult trials at various stages of drug 
development; (2) considerations for dosing and pharmacokinetic 
evaluations; (3) safety monitoring; and (4) ethical requirements.

[[Page 25676]]

    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 
``Considerations for the Inclusion of Adolescent Patients in Adult 
Oncology Clinical Trials.'' 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 draft guidance is not subject to 
Executive Order 12866.

II. Electronic Access

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

    Dated: May 29, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-11828 Filed 6-1-18; 8:45 am]
 BILLING CODE 4164-01-P
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