Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Guidance for Industry; Availability, 54613-54615 [2019-22117]

Download as PDF 54613 Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Notices TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 Number of responses per respondent Number of respondents Product reporting for compounding outsourcing facilities Average burden per response Total annual responses Total hours Initial product reports ........................................................... Waiver request from electronic submission of initial product reports ........................................................................ June product reports ............................................................ December product reports ................................................... Waiver request from electronic submission of product reports .................................................................................. 75 1.01 76 2 152 1 75 75 1 1.01 1.01 1 76 76 1 0.5 0.5 1 38 38 1 1 1 1 1 Total .............................................................................. ........................ ........................ ........................ ........................ 230 1 There are no capital costs or operating and maintenance costs associated with this collection of information. Based on current data for outsourcing facilities, we estimate that 75 outsourcing facilities will submit an initial report identifying all drugs compounded in the facility in the previous 6 months. For the purposes of this estimate, each product’s structured product labeling (SPL) submission is considered a separate response, and therefore each facility’s product report will include multiple responses. Taking into account that a particular product that is compounded into different strengths from different sources of active ingredient can be reported in a single SPL response, we estimate that each facility will average 76 products. Our estimate is based on current product reporting data. We expect each product report will consist of multiple SPL responses per facility and estimate that preparing and submitting this information electronically may take up to 2 hours for each initial SPL response. We also estimate that the 75 registered outsourcing facilities will submit a report twice each year identifying all drugs compounded at the facility in the previous 6 months. As stated above, we estimate on average 76 SPL responses per facility and that preparing and submitting this information electronically will take approximately 30 minutes per response. We have reduced our burden estimate for semiannual product submissions because outsourcing facilities can save each SPL response once initially created and submitted. For subsequent reports, an outsourcing facility may resubmit the same file(s) after changing the RootID and version number (both SPL metadata), effective date (to identify the reporting period), and the number of units produced, along with other data as appropriate, to appropriate values for the reporting period. Furthermore, if a product was not compounded during a particular reporting period, no SPL response needs be sent for that product during that reporting period. VerDate Sep<11>2014 19:50 Oct 09, 2019 Jkt 250001 We expect to receive no more than one waiver request, each, from the electronic submission process for initial product reports and semiannual reports, and that each waiver request will take 1 hour to prepare and submit. Based on submissions we have received, we have reduced the number of responses significantly since our original estimate establishing the collection. This results in an overall reduction to the information collection by 36,072 hours. Dated: October 4, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–22189 Filed 10–9–19; 8:45 am] DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2018–D–0944] Electronic Submissions Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination; Guidance for Industry; Availability Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final 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 at FDA, describes an optional streamlined submission process to determine whether use of an investigational in vitro diagnostic in an oncology clinical trial is considered significant risk, nonsignificant risk, or exempt from investigational device SUMMARY: PO 00000 Frm 00029 Fmt 4703 The announcement of the guidance is published in the Federal Register on October 10, 2019. ADDRESSES: You may submit either electronic or written comments on Agency guidances at any time as follows: DATES: BILLING CODE 4164–01–P AGENCY: exemption requirements. In the streamlined process, the sponsor submits all information about the oncology trial (including information about the investigational in vitro diagnostic) to the investigational new drug application (IND). As part of IND review, the Center for Biologics Evaluation and Research (CBER) works with the Center for Drug Evaluation and Research (CDER), or CDER or CBER works with the Center for Devices and Radiological Health (CDRH), as appropriate, to determine if the investigational in vitro diagnostic is significant risk, nonsignificant risk, or exempt. Sfmt 4703 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 E:\FR\FM\10OCN1.SGM 10OCN1 54614 Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Notices 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.’’ 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/ VerDate Sep<11>2014 19:50 Oct 09, 2019 Jkt 250001 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 this guidance to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Building, 4th Floor, Silver Spring, MD 20993– 0002; the Office of Communication and Education, CDRH-Division of Industry and Consumer Education, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver Spring, MD 20993–0002; or the Office of Communication, Outreach, and Development, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993–0002. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the guidance document. FOR FURTHER INFORMATION CONTACT: Julie Schneider, Oncology Center of Excellence, 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: I. Background FDA is announcing the availability of a final guidance for industry entitled ‘‘Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.’’ This guidance describes an optional streamlined submission process for determining PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 whether use of an investigational in vitro diagnostic in an oncology clinical trial under an IND (an oncology codevelopment program) is significant risk, nonsignificant risk, or exempt from investigational device exemption requirements. In the traditional submission process, many sponsors submitted a study risk determination Q-submission to the appropriate center (CDRH or CBER) and an IND to the appropriate center (CBER or CDER). In the streamlined process, all information regarding the oncology codevelopment program (including investigational in vitro diagnostic information) is initially submitted to the IND. CBER or CDER works with CDRH or CDER works with CBER, as appropriate, to determine whether the investigational in vitro diagnostic is significant risk, nonsignificant risk, or exempt. If the investigational in vitro diagnostic in the trial is determined to be significant risk in the streamlined process, the sponsor may need to submit an investigational device exemption to CDRH in addition to submitting an IND to CDER. This guidance finalizes the draft guidance of the same name issued on April 16, 2018 (83 FR 16366). All public comments received on the draft guidance have been considered, and the guidance has been revised as appropriate along with a few editorial changes. Major changes from the draft to the final version included adding language to clarify that sponsors will receive significant risk determinations within the 30-day review period for the IND and to clarify that the streamlined submission process only applies to new INDs (not additional protocols added to an existing IND, or IND amendments) and adding the definition of noninvasive in 21 CFR 812.3(k) to the glossary. This guidance is being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). The guidance represents the current thinking of FDA on ‘‘Investigational In Vitro Diagnostics in Oncology Trials: Streamlined Submission Process for Study Risk Determination.’’ 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. 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 E:\FR\FM\10OCN1.SGM 10OCN1 Federal Register / Vol. 84, No. 197 / Thursday, October 10, 2019 / Notices 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 entitled ‘‘Requests for Feedback and Meetings for Medical Device Submissions: The Q-Submission Program’’ (available at https:// www.fda.gov/media/114034/download) have been approved under OMB control number 0910–0756. III. Electronic Access Persons with access to the internet may obtain the guidance at https:// www.fda.gov/drugs/guidancecompliance-regulatory-information/ guidances-drugs, https://www.fda.gov/ vaccines-blood-biologics/guidancecompliance-regulatory-informationbiologics/biologics-guidances, https:// www.fda.gov/medical-devices/deviceadvice-comprehensive-regulatoryassistance/guidance-documentsmedical-devices-and-radiation-emittingproducts, or https:// www.regulations.gov. Dated: October 4, 2019. Lowell J. Schiller, Principal Associate Commissioner for Policy. [FR Doc. 2019–22117 Filed 10–9–19; 8:45 am] BILLING CODE 4164–01–P VerDate Sep<11>2014 19:50 Oct 09, 2019 Jkt 250001 DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission to OMB for Review and Approval; Public Comment Request; Information Collection Request Title: Ryan White HIV/AIDS Program (RWHAP) Compilation of Best Practice Strategies and Interventions, OMB No. 0906–xxxx–NEW Health Resources and Services Administration (HRSA), Department of Health and Human Services. ACTION: Notice. AGENCY: In compliance with of the Paperwork Reduction Act of 1995, HRSA has submitted an Information Collection Request (ICR) to the Office of Management and Budget (OMB) for review and approval. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public during the review and approval period. DATES: Comments on this ICR should be received no later than November 12, 2019. SUMMARY: Submit your comments, including the ICR Title, to the desk officer for HRSA, either by email to OIRA_submission@omb.eop.gov or by fax to 202–395–5806. FOR FURTHER INFORMATION CONTACT: To request a copy of the clearance requests submitted to OMB for review, email Lisa Wright-Solomon, the HRSA Information Collection Clearance Officer at paperwork@hrsa.gov or call (301) 443– 1984. SUPPLEMENTARY INFORMATION: Information Collection Request Title: Ryan White HIV/AIDS Program (RWHAP) Compilation of Best Practice Strategies and Interventions, OMB No. 0906–xxxx–New Abstract: HRSA’s RWHAP funds and coordinates with cities, states, and local clinics/community-based organizations to deliver efficient and effective HIV care, treatment, and support to lowincome people with HIV (PWH). Nearly two-thirds of clients (patients) live at or below 100 percent of the Federal poverty level and approximately threequarters of RWHAP clients are racial/ ethnic minorities. Since 1990, the RWHAP has developed a comprehensive system of safety net providers who deliver high quality direct health care and support services to over half a million people living with ADDRESSES: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 54615 HIV (PLWH)—more than 50 percent of all people living with diagnosed HIV in the United States. HRSA is developing a comprehensive, web-based compilation of RWHAP recipient and subrecipient best practice strategies and interventions. When completed, the online recipient compilation will be housed on TargetHIV.org (HRSA’s technical assistance site for recipients and subrecipients) and structured to allow programs to easily search and identify RWHAP best practice strategies and interventions for implementation. Recipients and subrecipients may voluntarily complete a submission form, also housed on TargetHIV.org, when they have a best practice strategy or intervention to share. Strategies and interventions that meet certain criteria will be incorporated into the online compilation. The project team has developed a draft submission form and criteria for the types of strategies and interventions to be included in the compilation based on: (1) The quality and relevance of the approach to the RWHAP; (2) the level of feasibility, replicability, and sustainability; and (3) the quality of evidence that supports the approach’s results. Specifically, this information collection request involves three forms of data collection as described below. 1. Pre-Submission Screening Form: Through extensive outreach, the project team expects up to 70 recipients and subrecipients to express interest in submission. They will be asked four screening questions to determine whether they are eligible for inclusion in the compilation. 2. Submission Form: Recipients and subrecipients that screen eligible will then complete a submission form describing their strategy or intervention, including service delivery model, target population, expected or achieved outcomes, and resource requirements. The project team will score the submissions based on the established criteria. 3. Site Visit Discussion Guide: The project team will conduct up to 30 site visits to test the criteria and gather feedback on the submission form and compilation. The half-day site visits will involve individual or small group discussions with program staff involved in implementation (e.g., program managers, direct service providers, and evaluators). The project team will then revise the submission form, criteria, and compilation template based on feedback. A 60-day Federal Register Notice was published in the Federal Register on E:\FR\FM\10OCN1.SGM 10OCN1

Agencies

[Federal Register Volume 84, Number 197 (Thursday, October 10, 2019)]
[Notices]
[Pages 54613-54615]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-22117]


-----------------------------------------------------------------------

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; 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 final 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 at FDA, describes an 
optional streamlined submission process to determine whether use of an 
investigational in vitro diagnostic in an oncology clinical trial is 
considered significant risk, nonsignificant risk, or exempt from 
investigational device exemption requirements. In the streamlined 
process, the sponsor submits all information about the oncology trial 
(including information about the investigational in vitro diagnostic) 
to the investigational new drug application (IND). As part of IND 
review, the Center for Biologics Evaluation and Research (CBER) works 
with the Center for Drug Evaluation and Research (CDER), or CDER or 
CBER works with the Center for Devices and Radiological Health (CDRH), 
as appropriate, to determine if the investigational in vitro diagnostic 
is significant risk, nonsignificant risk, or exempt.

DATES: The announcement of the guidance is published in the Federal 
Register on October 10, 2019.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you

[[Page 54614]]

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.'' 
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 this guidance to the 
Division of Drug Information, Center for Drug Evaluation and Research, 
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale 
Building, 4th Floor, Silver Spring, MD 20993-0002; the Office of 
Communication and Education, CDRH-Division of Industry and Consumer 
Education, Center for Devices and Radiological Health, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4621, Silver 
Spring, MD 20993-0002; or the Office of Communication, Outreach, and 
Development, Center for Biologics Evaluation and Research, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 3128, 
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to 
assist that office in processing your requests. See the SUPPLEMENTARY 
INFORMATION section for electronic access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Julie Schneider, Oncology Center of 
Excellence, 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: 

I. Background

    FDA is announcing the availability of a final guidance for industry 
entitled ``Investigational In Vitro Diagnostics in Oncology Trials: 
Streamlined Submission Process for Study Risk Determination.'' This 
guidance describes an optional streamlined submission process for 
determining whether use of an investigational in vitro diagnostic in an 
oncology clinical trial under an IND (an oncology codevelopment 
program) is significant risk, nonsignificant risk, or exempt from 
investigational device exemption requirements.
    In the traditional submission process, many sponsors submitted a 
study risk determination Q-submission to the appropriate center (CDRH 
or CBER) and an IND to the appropriate center (CBER or CDER). In the 
streamlined process, all information regarding the oncology 
codevelopment program (including investigational in vitro diagnostic 
information) is initially submitted to the IND. CBER or CDER works with 
CDRH or CDER works with CBER, as appropriate, to determine whether the 
investigational in vitro diagnostic is significant risk, nonsignificant 
risk, or exempt. If the investigational in vitro diagnostic in the 
trial is determined to be significant risk in the streamlined process, 
the sponsor may need to submit an investigational device exemption to 
CDRH in addition to submitting an IND to CDER.
    This guidance finalizes the draft guidance of the same name issued 
on April 16, 2018 (83 FR 16366). All public comments received on the 
draft guidance have been considered, and the guidance has been revised 
as appropriate along with a few editorial changes. Major changes from 
the draft to the final version included adding language to clarify that 
sponsors will receive significant risk determinations within the 30-day 
review period for the IND and to clarify that the streamlined 
submission process only applies to new INDs (not additional protocols 
added to an existing IND, or IND amendments) and adding the definition 
of noninvasive in 21 CFR 812.3(k) to the glossary.
    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on ``Investigational In Vitro Diagnostics in 
Oncology Trials: Streamlined Submission Process for Study Risk 
Determination.'' 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. 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

[[Page 54615]]

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 entitled ``Requests for Feedback and Meetings for 
Medical Device Submissions: The Q-Submission Program'' (available at 
https://www.fda.gov/media/114034/download) have been approved under OMB 
control number 0910-0756.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at 
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, 
https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products, or https://www.regulations.gov.

    Dated: October 4, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-22117 Filed 10-9-19; 8:45 am]
 BILLING CODE 4164-01-P
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