83 FR 25675 - Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 107 (June 4, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 107 (June 4, 2018)
| Page Range | 25675-25676 | |
| FR Document | 2018-11828 |
[Federal Register Volume 83, Number 107 (Monday, June 4, 2018)] [Notices] [Pages 25675-25676] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-11828] [[Page 25675]] ----------------------------------------------------------------------- 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[Docket No. FDA-2018-D-1540] Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Considerations for the Inclusion of Adolescent Patients in Adult Oncology Clinical Trials.'' The purpose of this draft guidance is to provide the pharmaceutical industry, clinical investigators, and institutional review boards with information to facilitate the inclusion of adolescent patients (for purposes of this draft guidance defined as ages 12 to 17) in relevant adult oncology clinical trials. The draft guidance focuses on appropriate criteria for inclusion in adult trials at various stages of drug development, considerations for dosing and pharmacokinetic evaluations,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 DATES: Submit either electronic or written comments on the draft guidance by August 3, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.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, 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, http://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
![Federal Register / Vol. 83, No. 107 / Monday, June 4, 2018 / Notices 25675
DEPARTMENT OF HEALTH AND • If you want to submit a comment the information at: https://www.gpo.gov/
HUMAN SERVICES with confidential information that you fdsys/pkg/FR-2015-09-18/pdf/2015-
do not wish to be made available to the 23389.pdf.
Food and Drug Administration public, submit the comment as a Docket: For access to the docket to
[Docket No. FDA–2018–D–1540] written/paper submission and in the read background documents or the
manner detailed (see ‘‘Written/Paper electronic and written/paper comments
Considerations for the Inclusion of Submissions’’ and ‘‘Instructions’’). received, go to https://
Adolescent Patients in Adult Oncology www.regulations.gov and insert the
Written/Paper Submissions docket number, found in brackets in the
Clinical Trials; Draft Guidance for
Industry; Availability Submit written/paper submissions as heading of this document, into the
follows: ‘‘Search’’ box and follow the prompts
AGENCY: Food and Drug Administration, • Mail/Hand delivery/Courier (for and/or go to the Dockets Management
HHS. written/paper submissions): Dockets Staff, 5630 Fishers Lane, Rm. 1061,
ACTION: Notice of availability. Management Staff (HFA–305), Food and Rockville, MD 20852.
Drug Administration, 5630 Fishers You may submit comments on any
SUMMARY: The Food and Drug Lane, Rm. 1061, Rockville, MD 20852. guidance at any time (see 21 CFR
Administration (FDA or Agency) is • For written/paper comments 10.115(g)(5)).
announcing the availability of a draft submitted to the Dockets Management Submit written requests for single
guidance for industry entitled Staff, FDA will post your comment, as copies of the draft guidance to the
‘‘Considerations for the Inclusion of well as any attachments, except for Division of Drug Information, Center for
Adolescent Patients in Adult Oncology information submitted, marked and Drug Evaluation and Research, Food
Clinical Trials.’’ The purpose of this identified, as confidential, if submitted and Drug Administration, 10001 New
draft guidance is to provide the as detailed in ‘‘Instructions.’’ Hampshire Ave., Hillandale Building,
pharmaceutical industry, clinical Instructions: All submissions received 4th Floor, Silver Spring, MD 20993–
investigators, and institutional review must include the Docket No. FDA– 0002, or Office of Communication,
boards with information to facilitate the 2018–D–1540 for ‘‘Considerations for Outreach, and Development, Center for
inclusion of adolescent patients (for the Inclusion of Adolescent Patients in Biologics Evaluation and Research,
purposes of this draft guidance defined Adult Oncology Clinical Trials.’’ Food and Drug Administration, 10903
as ages 12 to 17) in relevant adult Received comments will be placed in New Hampshire Ave., Bldg. 71, Rm.
oncology clinical trials. The draft the docket and, except for those 3128, Silver Spring, MD 20993–0002.
guidance focuses on appropriate criteria submitted as ‘‘Confidential Send one self-addressed adhesive label
for inclusion in adult trials at various Submissions,’’ publicly viewable at to assist that office in processing your
stages of drug development, https://www.regulations.gov or at the requests. See the SUPPLEMENTARY
considerations for dosing and Dockets Management Staff between 9 INFORMATION section for electronic
pharmacokinetic evaluations, safety a.m. and 4 p.m., Monday through access to the draft guidance document.
monitoring, and ethical requirements. Friday. FOR FURTHER INFORMATION CONTACT:
DATES: Submit either electronic or • Confidential Submissions—To Meredith K. Chuk, Center for Drug
written comments on the draft guidance submit a comment with confidential Evaluation and Research, Food and
by August 3, 2018 to ensure that the information that you do not wish to be Drug Administration, 5901–B
Agency considers your comment on this made publicly available, submit your Ammendale Rd., Beltsville, MD 20705–
draft guidance before it begins work on comments only as a written/paper 1266, 301–796–2320; or Stephen Ripley,
the final version of the guidance. submission. You should submit two Center for Biologics Evaluation and
ADDRESSES: You may submit comments copies total. One copy will include the Research, Food and Drug
on any guidance at any time as follows: information you claim to be confidential Administration, 10903 New Hampshire
with a heading or cover note that states Ave, Bldg. 71, Rm. 7301, Silver Spring,
Electronic Submissions ‘‘THIS DOCUMENT CONTAINS MD 20993–0002, 240–402–7911.
Submit electronic comments in the CONFIDENTIAL INFORMATION.’’ The SUPPLEMENTARY INFORMATION:
following way: Agency will review this copy, including
• Federal eRulemaking Portal: the claimed confidential information, in I. Background
https://www.regulations.gov. Follow the its consideration of comments. The FDA is announcing the availability of
instructions for submitting comments. second copy, which will have the a draft guidance for industry entitled
Comments submitted electronically, claimed confidential information ‘‘Considerations for the Inclusion of
including attachments, to https:// redacted/blacked out, will be available Adolescent Patients in Adult Oncology
www.regulations.gov will be posted to for public viewing and posted on Clinical Trials.’’ The purpose of this
the docket unchanged. Because your https://www.regulations.gov. Submit draft guidance is to provide the
comment will be made public, you are both copies to the Dockets Management pharmaceutical industry, clinical
solely responsible for ensuring that your Staff. If you do not wish your name and investigators, and institutional review
comment does not include any contact information to be made publicly boards with information to facilitate the
confidential information that you or a available, you can provide this inclusion of adolescent patients (for
third party may not wish to be posted, information on the cover sheet and not purposes of this draft guidance defined
such as medical information, your or in the body of your comments and you as ages 12 to 17) in relevant adult
anyone else’s Social Security number, or must identify this information as
sradovich on DSK3GMQ082PROD with NOTICES
oncology clinical trials. The following
confidential business information, such ‘‘confidential.’’ Any information marked topics are the focus of this guidance: (1)
as a manufacturing process. Please note as ‘‘confidential’’ will not be disclosed Appropriate criteria for inclusion in
that if you include your name, contact except in accordance with 21 CFR 10.20 adult trials at various stages of drug
information, or other information that and other applicable disclosure law. For development; (2) considerations for
identifies you in the body of your more information about FDA’s posting dosing and pharmacokinetic
comments, that information will be of comments to public dockets, see 80 evaluations; (3) safety monitoring; and
posted on https://www.regulations.gov. FR 56469, September 18, 2015, or access (4) ethical requirements.
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![25676 Federal Register / Vol. 83, No. 107 / Monday, June 4, 2018 / Notices
This draft guidance is being issued This action terminates the of those buildings. For rating purposes,
consistent with FDA’s good guidance appointment of Elizabeth Turner as the currently effective community
practices regulation (21 CFR 10.115). Federal Coordinating Officer for this number is shown in the table below and
The draft guidance, when finalized, will disaster. must be used for all new policies and
represent the current thinking of FDA The following Catalog of Federal Domestic renewals.
on ‘‘Considerations for the Inclusion of Assistance Numbers (CFDA) are to be used DATES: These flood hazard
Adolescent Patients in Adult Oncology for reporting and drawing funds: 97.030, determinations will be finalized on the
Clinical Trials.’’ It does not establish Community Disaster Loans; 97.031, Cora
dates listed in the table below and
any rights for any person and is not Brown Fund; 97.032, Crisis Counseling;
97.033, Disaster Legal Services; 97.034, revise the FIRM panels and FIS report
binding on FDA or the public. You can in effect prior to this determination for
use an alternative approach if it satisfies Disaster Unemployment Assistance (DUA);
97.046, Fire Management Assistance Grant; the listed communities.
the requirements of the applicable 97.048, Disaster Housing Assistance to From the date of the second
statutes and regulations. This draft Individuals and Households In Presidentially publication of notification of these
guidance is not subject to Executive Declared Disaster Areas; 97.049, changes in a newspaper of local
Order 12866. Presidentially Declared Disaster Assistance— circulation, any person has 90 days in
Disaster Housing Operations for Individuals which to request through the
II. Electronic Access
and Households; 97.050, Presidentially
community that the Deputy Associate
Persons with access to the internet Declared Disaster Assistance to Individuals
Administrator for Insurance and
may obtain the draft guidance at https:// and Households—Other Needs; 97.036,
Disaster Grants—Public Assistance Mitigation reconsider the changes. The
www.fda.gov/Drugs/Guidance
(Presidentially Declared Disasters); 97.039, flood hazard determination information
ComplianceRegulatoryInformation/
Hazard Mitigation Grant. may be changed during the 90-day
Guidances/default.htm, http://
period.
www.fda.gov/BiologicsBloodVaccines/ Brock Long,
GuidanceComplianceRegulatory Administrator, Federal Emergency ADDRESSES: The affected communities
Information/default.htm, or https:// Management Agency. are listed in the table below. Revised
www.regulations.gov. [FR Doc. 2018–11874 Filed 6–1–18; 8:45 am] flood hazard information for each
Dated: May 29, 2018. BILLING CODE 9111–23–P
community is available for inspection at
both the online location and the
Leslie Kux,
respective community map repository
Associate Commissioner for Policy.
DEPARTMENT OF HOMELAND address listed in the table below.
[FR Doc. 2018–11828 Filed 6–1–18; 8:45 am]
SECURITY Additionally, the current effective FIRM
BILLING CODE 4164–01–P and FIS report for each community are
Federal Emergency Management accessible online through the FEMA
Agency Map Service Center at https://
DEPARTMENT OF HOMELAND msc.fema.gov for comparison.
SECURITY [Docket ID FEMA–2018–0002; Internal
Agency Docket No. FEMA–B–1831]
Submit comments and/or appeals to
the Chief Executive Officer of the
Federal Emergency Management community as listed in the table below.
Agency Changes in Flood Hazard
Determinations FOR FURTHER INFORMATION CONTACT: Rick
[Internal Agency Docket No. FEMA–4364– Sacbibit, Chief, Engineering Services
DR; Docket ID FEMA–2018–0001] AGENCY: Federal Emergency Branch, Federal Insurance and
Management Agency, DHS. Mitigation Administration, FEMA, 400
North Carolina; Amendment No. 1 to ACTION: Notice. C Street SW, Washington, DC 20472
Notice of a Major Disaster Declaration
SUMMARY: This notice lists communities (202) 646–7659, or (email)
AGENCY: Federal Emergency where the addition or modification of patrick.sacbibit@fema.dhs.gov; or visit
Management Agency, DHS. Base Flood Elevations (BFEs), base flood the FEMA Map Information eXchange
ACTION: Notice. depths, Special Flood Hazard Area (FMIX) online at https://
(SFHA) boundaries or zone www.floodmaps.fema.gov/fhm/fmx_
SUMMARY: This notice amends the notice main.html.
of a major disaster declaration for the designations, or the regulatory floodway
State of North Carolina (FEMA–4364– (hereinafter referred to as flood hazard SUPPLEMENTARY INFORMATION: The
DR), dated May 8, 2018, and related determinations), as shown on the Flood specific flood hazard determinations are
determinations. Insurance Rate Maps (FIRMs), and not described for each community in
where applicable, in the supporting this notice. However, the online
DATE: The amendment was issued on Flood Insurance Study (FIS) reports, location and local community map
May 17, 2018. prepared by the Federal Emergency repository address where the flood
FOR FURTHER INFORMATION CONTACT: Management Agency (FEMA) for each hazard determination information is
Dean Webster, Office of Response and community, is appropriate because of available for inspection is provided.
Recovery, Federal Emergency new scientific or technical data. The Any request for reconsideration of
Management Agency, 500 C Street SW, FIRM, and where applicable, portions of flood hazard determinations must be
Washington, DC 20472, (202) 646–2833. the FIS report, have been revised to submitted to the Chief Executive Officer
SUPPLEMENTARY INFORMATION: The reflect these flood hazard of the community as listed in the table
sradovich on DSK3GMQ082PROD with NOTICES
Federal Emergency Management Agency determinations through issuance of a below.
(FEMA) hereby gives notice that Letter of Map Revision (LOMR), in The modifications are made pursuant
pursuant to the authority vested in the accordance with Federal Regulations. to section 201 of the Flood Disaster
Administrator, under Executive Order The LOMR will be used by insurance Protection Act of 1973, 42 U.S.C. 4105,
12148, as amended, Glen Sachtleben, of agents and others to calculate and are in accordance with the National
FEMA is appointed to act as the Federal appropriate flood insurance premium Flood Insurance Act of 1968, 42 U.S.C.
Coordinating Officer for this disaster. rates for new buildings and the contents 4001 et seq., and with 44 CFR part 65.
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Document Created: 2018-06-02 00:47:48
Document Modified: 2018-06-02 00:47:48
| 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 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. | |
| 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. | |
| FR Citation | 83 FR 25675 |
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