83 FR 16366 - Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 83, Issue 73 (April 16, 2018)
Food and Drug Administration
Federal Register Volume 83, Issue 73 (April 16, 2018)
| Page Range | 16366-16367 | |
| FR Document | 2018-07812 |
[Federal Register Volume 83, Number 73 (Monday, April 16, 2018)] [Notices] [Pages 16366-16367] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2018-07812] [[Page 16366]] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2018-D-0944] Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled ``Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.'' This guidance, developed by the Oncology Center of Excellence, Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER), and Center for Devices and Radiological Health (CDRH) at FDA, describes an optional streamlined submission process to determine whether an investigational in vitro diagnostic in an oncology clinical trial under an investigational new drug application (IND) (an oncology co-development program) is significant risk. In the streamlined process, all information about the oncology trial (including information about the investigational in vitro diagnostic) is submitted to the IND. As part of IND review, CBER or CDER works with CDRH to determine if the investigational in vitro diagnostic is significant risk. DATES: Submit either electronic or written comments on the draft guidance by June 15, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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-0944 for ``Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Draft Guidance for Industry; Availability.'' Received comments will be placed in the docket and, except for those submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the 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; 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; or Office of the Center Director, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-0002, or via email to [email protected]. See the SUPPLEMENTARY INFORMATION section for electronic access to the draft guidance document. FOR FURTHER INFORMATION CONTACT: Julie Schneider, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2208, Silver Spring, MD 20993, 240-402- 4658; Yun-Fu Hu, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5676, Silver Spring, MD 20993-0002, 301-796-6170; 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: [[Page 16367]] I. Background FDA is announcing the availability of a draft guidance for industry entitled ``Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.'' This guidance, developed by the Oncology Center of Excellence, CDER, CBER, and CDRH at FDA, describes an optional streamlined submission process to determine whether an investigational in vitro diagnostic in an oncology clinical trial under an IND (an oncology co-development program) is significant risk. In the traditional submission process, many sponsors submitted a study risk determination Q-submission to CDRH and an IND to the appropriate center (CBER or CDER). In the streamlined process, all information regarding the oncology co-development program (including investigational in vitro diagnostic information) is initially submitted to the IND. CBER or CDER works with CDRH to determine whether the in vitro diagnostic is significant risk. Initially, FDA plans to implement the streamlined submission process for oncology-related products, because FDA has received the greatest number of co-development submissions in this disease area and has the most experience evaluating whether the in vitro diagnostic is significant risk. However, FDA is interested in receiving comments on whether the streamlined submission process should be extended to other disease areas in the future. This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). This draft guidance is not final nor is it in effect at this time. The draft guidance, when finalized, will represent the current thinking of FDA on a streamlined submission process for study risk determination for in vitro diagnostics in oncology 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 guidance is not subject to Executive Order 12866. II. The Paperwork Reduction Act of 1995 This guidance refers to currently approved collections of information. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 809 have been approved under OMB control number 0910-0485; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB control number 0910-0755; the collections of information in 21 CFR 56.115 have been approved under OMB control number 0910-0130; the collections of information in 21 CFR 50.23 have been approved under OMB control number 0910-0586; the collections of information in 21 CFR part 812 have been approved under OMB control number 0910-0078; the collections of information in 21 CFR part 820 have been approved under OMB control number 0910-0073; the collections of information in 21 CFR part 312 have been approved under OMB control number 0910-0014; and the collections of information in 21 CFR part 314 have been approved under OMB control number 0910-0001. The collections of information in the guidance document titled ``Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' (available at https://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm311176.pdf) have been approved under OMB control number 0910-0756. III. 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/Guidances/default.htm, https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm, or https://www.regulations.gov. Dated: April 9, 2018. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2018-07812 Filed 4-13-18; 8:45 am] BILLING CODE 4164-01-P
![16366 Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices
DEPARTMENT OF HEALTH AND such as medical information, your or available, you can provide this
HUMAN SERVICES anyone else’s Social Security number, or information on the cover sheet and not
confidential business information, such in the body of your comments and you
Food and Drug Administration as a manufacturing process. Please note must identify this information as
[Docket No. FDA–2018–D–0944] that if you include your name, contact ‘‘confidential.’’ Any information marked
information, or other information that as ‘‘confidential’’ will not be disclosed
Investigational In Vitro Diagnostics in identifies you in the body of your except in accordance with 21 CFR 10.20
Oncology Trials: Streamlined comments, that information will be and other applicable disclosure law. For
Submission Process for Study Risk posted on https://www.regulations.gov. more information about FDA’s posting
Determination; Draft Guidance for • If you want to submit a comment of comments to public dockets, see 80
Industry; Availability with confidential information that you FR 56469, September 18, 2015, or access
do not wish to be made available to the the information at: https://www.gpo.gov/
AGENCY: Food and Drug Administration, public, submit the comment as a fdsys/pkg/FR-2015-09-18/pdf/2015-
HHS. written/paper submission and in the 23389.pdf.
ACTION: Notice of availability. manner detailed (see ‘‘Written/Paper Docket: For access to the docket to
Submissions’’ and ‘‘Instructions’’). read background documents or the
SUMMARY: The Food and Drug
Administration (FDA or Agency) is Written/Paper Submissions electronic and written/paper comments
announcing the availability of a draft Submit written/paper submissions as received, go to https://
guidance for industry entitled follows: www.regulations.gov and insert the
‘‘Investigational In Vitro Diagnostics in • Mail/Hand Delivery/Courier (for docket number, found in brackets in the
Oncology Trials: Streamlined written/paper submissions): Dockets heading of this document, into the
Submission Process for Study Risk Management Staff (HFA–305), Food and ‘‘Search’’ box and follow the prompts
Determination.’’ This guidance, Drug Administration, 5630 Fishers and/or go to the Dockets Management
developed by the Oncology Center of Lane, Rm. 1061, Rockville, MD 20852. Staff, 5630 Fishers Lane, Rm. 1061,
Excellence, Center for Drug Evaluation • For written/paper comments Rockville, MD 20852.
and Research (CDER), Center for submitted to the Dockets Management You may submit comments on any
Biologics Evaluation and Research Staff, FDA will post your comment, as guidance at any time (see 21 CFR
(CBER), and Center for Devices and well as any attachments, except for 10.115(g)(5)).
Radiological Health (CDRH) at FDA, information submitted, marked and Submit written requests for single
describes an optional streamlined identified, as confidential, if submitted copies of the draft guidance to the
submission process to determine as detailed in ‘‘Instructions.’’ Division of Drug Information, Center for
whether an investigational in vitro Instructions: All submissions received Drug Evaluation and Research, Food
diagnostic in an oncology clinical trial must include the Docket No. FDA– and Drug Administration, 10001 New
under an investigational new drug 2018–D–0944 for ‘‘Investigational In Hampshire Ave., Hillandale Building,
application (IND) (an oncology co- Vitro Diagnostics in Oncology Trials: 4th Floor, Silver Spring, MD 20993–
development program) is significant Streamlined Submission Process for 0002; Office of Communication,
risk. In the streamlined process, all Study Risk Determination; Draft Outreach, and Development, Center for
information about the oncology trial Guidance for Industry; Availability.’’ Biologics Evaluation and Research,
(including information about the Received comments will be placed in Food and Drug Administration, 10903
investigational in vitro diagnostic) is the docket and, except for those New Hampshire Ave., Bldg. 71, Rm.
submitted to the IND. As part of IND submitted as ‘‘Confidential 3128, Silver Spring, MD 20993–0002; or
review, CBER or CDER works with Submissions,’’ publicly viewable at Office of the Center Director, Center for
CDRH to determine if the investigational https://www.regulations.gov or at the Devices and Radiological Health, Food
in vitro diagnostic is significant risk. Dockets Management Staff between 9 and Drug Administration, 10903 New
DATES: Submit either electronic or a.m. and 4 p.m., Monday through Hampshire Ave., Bldg. 66, Rm. 5431,
written comments on the draft guidance Friday. Silver Spring, MD 20993–0002, or via
by June 15, 2018 to ensure that the • Confidential Submissions—To email to CDRH-Guidance@fda.hhs.gov.
Agency considers your comment on this submit a comment with confidential See the SUPPLEMENTARY INFORMATION
draft guidance before it begins work on information that you do not wish to be section for electronic access to the draft
the final version of the guidance. made publicly available, submit your guidance document.
ADDRESSES: You may submit comments comments only as a written/paper
submission. You should submit two FOR FURTHER INFORMATION CONTACT: Julie
on any guidance at any time as follows: Schneider, Center for Drug Evaluation
copies total. One copy will include the
Electronic Submissions information you claim to be confidential and Research, Food and Drug
Submit electronic comments in the with a heading or cover note that states Administration, 10903 New Hampshire
following way: ‘‘THIS DOCUMENT CONTAINS Ave., Bldg. 22, Rm. 2208, Silver Spring,
• Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The MD 20993, 240–402–4658; Yun-Fu Hu,
https://www.regulations.gov. Follow the Agency will review this copy, including Center for Devices and Radiological
instructions for submitting comments. the claimed confidential information, in Health, Food and Drug Administration,
Comments submitted electronically, its consideration of comments. The 10903 New Hampshire Ave., Bldg. 66,
including attachments, to https:// second copy, which will have the Rm. 5676, Silver Spring, MD 20993–
srobinson on DSK3G9T082PROD with NOTICES
www.regulations.gov will be posted to claimed confidential information 0002, 301–796–6170; or Stephen Ripley,
the docket unchanged. Because your redacted/blacked out, will be available Center for Biologics Evaluation and
comment will be made public, you are for public viewing and posted on Research, Food and Drug
solely responsible for ensuring that your https://www.regulations.gov. Submit Administration, 10903 New Hampshire
comment does not include any both copies to the Dockets Management Ave., Bldg. 71, Rm. 7301, Silver Spring,
confidential information that you or a Staff. If you do not wish your name and MD 20993–0002, 240–402–7911.
third party may not wish to be posted, contact information to be made publicly SUPPLEMENTARY INFORMATION:
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![Federal Register / Vol. 83, No. 73 / Monday, April 16, 2018 / Notices 16367
I. Background number 0910–0485; the collections of SUMMARY: The Food and Drug
FDA is announcing the availability of information in 21 CFR parts 50 and 56 Administration (FDA or Agency) is
a draft guidance for industry entitled have been approved under OMB control announcing the availability of a
‘‘Investigational In Vitro Diagnostics in number 0910–0755; the collections of guidance for industry entitled ‘‘Special
Oncology Trials: Streamlined information in 21 CFR 56.115 have been Protocol Assessment.’’ This guidance
Submission Process for Study Risk approved under OMB control number provides information about the
Determination.’’ This guidance, 0910–0130; the collections of procedures and general policies adopted
developed by the Oncology Center of information in 21 CFR 50.23 have been by the Center for Drug Evaluation and
Excellence, CDER, CBER, and CDRH at approved under OMB control number Research and the Center for Biologics
FDA, describes an optional streamlined 0910–0586; the collections of Evaluation and Research for special
submission process to determine information in 21 CFR part 812 have protocol assessment (SPA). This
whether an investigational in vitro been approved under OMB control guidance is intended to improve the
diagnostic in an oncology clinical trial number 0910–0078; the collections of quality of requests for SPAs and
under an IND (an oncology co- information in 21 CFR part 820 have accompanying submission materials,
development program) is significant been approved under OMB control and the quality of the resulting
risk. In the traditional submission number 0910–0073; the collections of interactions between sponsors and FDA.
process, many sponsors submitted a information in 21 CFR part 312 have This guidance finalizes the draft
study risk determination Q-submission been approved under OMB control guidance of the same name issued May
to CDRH and an IND to the appropriate number 0910–0014; and the collections 4, 2016, and replaces the guidance of
center (CBER or CDER). In the of information in 21 CFR part 314 have the same name issued May 17, 2002.
streamlined process, all information been approved under OMB control DATES: The announcement of the
regarding the oncology co-development number 0910–0001. The collections of guidance is published in the Federal
program (including investigational in information in the guidance document Register on April 16, 2018.
vitro diagnostic information) is initially titled ‘‘Requests for Feedback on ADDRESSES: You may submit either
submitted to the IND. CBER or CDER Medical Device Submissions: The Pre- electronic or written comments on
works with CDRH to determine whether Submission Program and Meetings with Agency guidances at any time as
the in vitro diagnostic is significant risk. Food and Drug Administration Staff’’ follows:
Initially, FDA plans to implement the (available at https://www.fda.gov/ucm/
streamlined submission process for groups/fdagov-public/@fdagov-meddev- Electronic Submissions
oncology-related products, because FDA gen/documents/document/ Submit electronic comments in the
has received the greatest number of co- ucm311176.pdf) have been approved following way:
development submissions in this under OMB control number 0910–0756. • Federal eRulemaking Portal:
disease area and has the most III. Electronic Access https://www.regulations.gov. Follow the
experience evaluating whether the in instructions for submitting comments.
vitro diagnostic is significant risk. Persons with access to the internet Comments submitted electronically,
However, FDA is interested in receiving may obtain the draft guidance at https:// including attachments, to https://
comments on whether the streamlined www.fda.gov/Drugs/ www.regulations.gov will be posted to
submission process should be extended GuidanceCompliance the docket unchanged. Because your
to other disease areas in the future. RegulatoryInformation/Guidances/ comment will be made public, you are
This draft guidance is being issued default.htm, https://www.fda.gov/ solely responsible for ensuring that your
consistent with FDA’s good guidance BiologicsBloodVaccines/ comment does not include any
practices regulation (21 CFR 10.115). GuidanceCompliance confidential information that you or a
This draft guidance is not final nor is it RegulatoryInformation/Guidances/ third party may not wish to be posted,
in effect at this time. The draft guidance, default.htm, https://www.fda.gov/ such as medical information, your or
when finalized, will represent the MedicalDevices/DeviceRegulation anyone else’s Social Security number, or
current thinking of FDA on a andGuidance/GuidanceDocuments/ confidential business information, such
streamlined submission process for default.htm, or https:// as a manufacturing process. Please note
study risk determination for in vitro www.regulations.gov. that if you include your name, contact
diagnostics in oncology trials. It does Dated: April 9, 2018. information, or other information that
not establish any rights for any person Leslie Kux, identifies you in the body of your
and is not binding on FDA or the public. Associate Commissioner for Policy. comments, that information will be
You can use an alternative approach if [FR Doc. 2018–07812 Filed 4–13–18; 8:45 am] posted on https://www.regulations.gov.
it satisfies the requirements of the BILLING CODE 4164–01–P
• If you want to submit a comment
applicable statutes and regulations. This with confidential information that you
guidance is not subject to Executive do not wish to be made available to the
Order 12866. DEPARTMENT OF HEALTH AND public, submit the comment as a
HUMAN SERVICES written/paper submission and in the
II. The Paperwork Reduction Act of
manner detailed (see ‘‘Written/Paper
1995 Food and Drug Administration Submissions’’ and ‘‘Instructions’’).
This guidance refers to currently
approved collections of information. [Docket No. FDA–2016–D–1174] Written/Paper Submissions
srobinson on DSK3G9T082PROD with NOTICES
These collections of information are Submit written/paper submissions as
subject to review by the Office of Special Protocol Assessment; follows:
Management and Budget (OMB) under Guidance for Industry; Availability • Mail/Hand Delivery/Courier (for
the Paperwork Reduction Act of 1995 AGENCY: Food and Drug Administration, written/paper submissions): Dockets
(44 U.S.C. 3501–3520). The collections HHS. Management Staff (HFA–305), Food and
of information in 21 CFR part 809 have Drug Administration, 5630 Fishers
ACTION: Notice of availability.
been approved under OMB control Lane, Rm. 1061, Rockville, MD 20852.
VerDate Sep<11>2014 19:42 Apr 13, 2018 Jkt 244001 PO 00000 Frm 00083 Fmt 4703 Sfmt 4703 E:\FR\FM\16APN1.SGM 16APN1](https://thefederalregister.org/doc/83_FR_16439/page/2.svg)
Document Created: 2018-04-14 02:19:26
Document Modified: 2018-04-14 02:19:26
| 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 June 15, 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 | Julie Schneider, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, Rm. 2208, Silver Spring, MD 20993, 240-402- 4658; Yun-Fu Hu, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5676, Silver Spring, MD 20993-0002, 301-796-6170; 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 16366 |
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