82 FR 60022 - Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products; Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards; Availability
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration Federal Register Volume 82, Issue 241 (December 18, 2017)
Food and Drug Administration
Federal Register Volume 82, Issue 241 (December 18, 2017)
| Page Range | 60022-60024 | |
| FR Document | 2017-27155 |
[Federal Register Volume 82, Number 241 (Monday, December 18, 2017)] [Notices] [Pages 60022-60024] From the Federal Register Online [www.thefederalregister.org] [FR Doc No: 2017-27155] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2017-N-6356] Investigational In Vitro Diagnostics Used in Clinical Investigations of Therapeutic Products; Draft Guidance for Industry, Food and Drug Administration Staff, Sponsors, and Institutional Review Boards; Availability AGENCY: Food and Drug Administration, HHS.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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ``Investigational IVDs Used in Clinical Investigations of Therapeutic Products.'' This draft guidance is intended to assist sponsors of clinical investigations of therapeutic products that also include investigational in vitro diagnostics (IVDs) and institutional review boards (IRBs) that review such investigations in complying with the Investigational Device Exemption (IDE) regulation. This draft guidance is also intended to assist FDA staff participating in the review of these investigations. This draft guidance is not final nor is it in effect at this time. DATES: Submit either electronic or written comments on the draft guidance by March 19, 2018 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.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.'' [[Page 60023]] Instructions: All submissions received must include the Docket No. FDA-2017-N-6356 for ``Investigational IVDs Used in Clinical Investigations of Therapeutic Products.'' 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)). An electronic copy of the guidance document is available for download from the internet. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written requests for a single hard copy of the draft guidance document entitled ``Investigational IVDs Used in Clinical Investigations of Therapeutic Products'' to the Office of the Center Director, Guidance and Policy Development, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431, 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 request. FOR FURTHER INFORMATION CONTACT: David Litwack, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4548, Silver Spring, MD 20993-0002, 301-796-6697 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, 240-402-7911. SUPPLEMENTARY INFORMATION: I. Background This draft guidance is intended to assist sponsors of clinical investigations of therapeutic products that also include investigational IVDs and IRBs that review such investigations in complying with the IDE regulation. This draft guidance is also intended to assist FDA staff participating in the review of these investigations. This draft guidance describes when the IDE regulation may apply to certain clinical investigations of therapeutic products; certain regulatory requirements that sponsors should be aware of as they develop and conduct such investigations; recommendations for determining the risk of investigational IVD use in a therapeutic product investigation; recommendations for IRBs in reviewing such investigations; and recommendations for content to provide in an IDE application, when required. Additionally, FDA is seeking feedback on the policy in the draft guidance regarding the need for an IDE for a significant risk study of an investigational IVD device with a therapeutic product under an IND. Specifically, FDA requests stakeholder perspectives on whether it would be beneficial to allow submission of all IDE components to an IND rather than require both an IDE and an IND. If such an approach would be beneficial, please identify any specific circumstances, for example a companion diagnostic and the associated therapeutic product, where efficiency may be improved or burden may be decreased, or both, without compromising patient safety. II. Significance of Guidance 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 Agency's current thinking on investigational IVDs used in clinical investigations of therapeutic products. 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. III. Electronic Access Persons interested in obtaining a copy of the draft guidance may do so by downloading an electronic copy from the internet. A search capability for all Center for Devices and Radiological Health guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This draft guidance is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ``Investigational IVDs Used in Clinical Investigations of Therapeutic Products'' may send an email request to [email protected] to receive an electronic copy of the document. Please use the document number 1400025 to identify the guidance you are requesting. IV. Paperwork Reduction Act of 1995 This draft 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 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 [[Page 60024]] 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 on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff'' have been approved under OMB control number 0910-0756. Dated: December 12, 2017. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2017-27155 Filed 12-15-17; 8:45 am] BILLING CODE 4164-01-P
![60022 Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
FOR FURTHER INFORMATION CONTACT: • Benefit-risk determination and Therapeutic Products.’’ This draft
Michael Pacanowski, Center for Drug therapeutic product labeling guidance is intended to assist sponsors
Evaluation and Research, Food and • Refining the indicated population of clinical investigations of therapeutic
Drug Administration, 10903 New after the initial approval products that also include
Hampshire Ave., Bldg. 71, Rm. 7301, In addition to comments on the investigational in vitro diagnostics
Silver Spring, MD 20993–0002, 301– general content of the draft guidance, (IVDs) and institutional review boards
796–3919; or Stephen Ripley, Center for FDA requests input on whether the (IRBs) that review such investigations in
Biologics Evaluation and Research, principles described for grouping complying with the Investigational
Food and Drug Administration, 10903 molecular subsets for clinical trial Device Exemption (IDE) regulation. This
New Hampshire Ave., Bldg. 71, Rm. enrollment should be limited to diseases draft guidance is also intended to assist
7301, Silver Spring, MD 20993–0002, with low-frequency molecular FDA staff participating in the review of
240–402–7911. alterations or whether they could be these investigations. This draft guidance
SUPPLEMENTARY INFORMATION: broadly applicable to all targeted is not final nor is it in effect at this time.
therapies. DATES: Submit either electronic or
I. Background This draft guidance is being issued written comments on the draft guidance
FDA is announcing the availability of consistent with FDA’s good guidance by March 19, 2018 to ensure that the
a draft guidance for industry entitled practices regulation (21 CFR 10.115). Agency considers your comment on this
‘‘Developing Targeted Therapies in The draft guidance, when finalized, will draft guidance before it begins work on
Low-Frequency Molecular Subsets of a represent the current thinking of FDA the final version of the guidance.
Disease.’’ This guidance is intended to on ‘‘Developing Targeted Therapies in ADDRESSES: You may submit comments
assist sponsors in designing drug Low-Frequency Molecular Subsets of a on any guidance at any time as follows:
development programs to generate the Disease.’’ It does not establish any rights
evidence needed to demonstrate efficacy for any person and is not binding on Electronic Submissions
of a targeted therapy across subsets of FDA or the public. You can use an Submit electronic comments in the
patients with different underlying alternative approach if it satisfies the following way:
molecular alterations within a disease, requirements of the applicable statutes • Federal eRulemaking Portal:
where some molecular alterations may and regulations. This guidance is not https://www.regulations.gov. Follow the
occur at low frequencies. subject to Executive Order 12866. instructions for submitting comments.
In recent years, advances in our Comments submitted electronically,
understanding of the molecular II. Electronic Access
including attachments, to https://
pathology of many diseases have led to Persons with access to the internet www.regulations.gov will be posted to
the development of targeted therapies. may obtain the draft guidance at either the docket unchanged. Because your
Although variability in drug response https://www.fda.gov/Drugs/Guidance comment will be made public, you are
has long been recognized in drug ComplianceRegulatoryInformation/ solely responsible for ensuring that your
development, targeted therapies present Guidances/default.htm, https:// comment does not include any
new challenges in addressing the www.fda.gov/BiologicsBloodVaccines/ confidential information that you or a
heterogeneity in drug response because GuidanceComplianceRegulatory third party may not wish to be posted,
the pharmacological effect of a targeted Information/Guidances/default.htm, or such as medical information, your or
therapy is often related to a particular https://www.regulations.gov. anyone else’s Social Security number, or
molecular alteration (e.g., a mutation, Dated: December 12, 2017. confidential business information, such
gene fusion, epigenetic change, etc.). Leslie Kux, as a manufacturing process. Please note
Many clinically defined diseases are that if you include your name, contact
Associate Commissioner for Policy.
caused by a range of different molecular information, or other information that
[FR Doc. 2017–27156 Filed 12–15–17; 8:45 am]
alterations, some of which may occur at identifies you in the body of your
BILLING CODE 4164–01–P
low frequencies, that impact a common comments, that information will be
protein or pathway involved in the posted on https://www.regulations.gov.
disease pathogenesis. In a population of
DEPARTMENT OF HEALTH AND • If you want to submit a comment
patients with the same clinical disease, with confidential information that you
HUMAN SERVICES
the heterogeneity in the molecular do not wish to be made available to the
etiology may result in different Food and Drug Administration public, submit the comment as a
responses to a particular therapy. written/paper submission and in the
However, certain targeted therapies may [Docket No. FDA–2017–N–6356]
manner detailed (see ‘‘Written/Paper
be effective in multiple groups of Submissions’’ and ‘‘Instructions’’).
patients that have different underlying Investigational In Vitro Diagnostics
molecular alterations. Therefore, FDA is Used in Clinical Investigations of Written/Paper Submissions
providing guidance on the type and Therapeutic Products; Draft Guidance Submit written/paper submissions as
quantity of evidence that can for Industry, Food and Drug follows:
demonstrate efficacy across molecular Administration Staff, Sponsors, and • Mail/Hand delivery/Courier (for
subsets within a disease. Institutional Review Boards; written/paper submissions): Dockets
This guidance addresses the following Availability Management Staff (HFA–305), Food and
important topics in evaluating the AGENCY: Food and Drug Administration, Drug Administration, 5630 Fishers
benefits and risks of targeted HHS. Lane, Rm. 1061, Rockville, MD 20852.
daltland on DSKBBV9HB2PROD with NOTICES
therapeutics within a disease where ACTION: Notice of availability. • For written/paper comments
some molecular alterations may occur at submitted to the Dockets Management
low frequencies: SUMMARY: The Food and Drug Staff, FDA will post your comment, as
• Identification of patients for inclusion Administration (FDA or Agency) is well as any attachments, except for
in clinical trials announcing the availability of the draft information submitted, marked and
• Interpretation of study results and guidance entitled ‘‘Investigational IVDs identified, as confidential, if submitted
generalizability of findings Used in Clinical Investigations of as detailed in ‘‘Instructions.’’
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![60024 Federal Register / Vol. 82, No. 241 / Monday, December 18, 2017 / Notices
been approved under OMB control Electronic Submissions information you claim to be confidential
number 0910–0073; the collections of Submit electronic comments in the with a heading or cover note that states
information in 21 CFR part 312 have following way: ‘‘THIS DOCUMENT CONTAINS
been approved under OMB control • Federal eRulemaking Portal: CONFIDENTIAL INFORMATION.’’ The
number 0910–0014; and the collections https://www.regulations.gov. Follow the Agency will review this copy, including
of information in 21 CFR part 314 have instructions for submitting comments. the claimed confidential information, in
been approved under OMB control Comments submitted electronically, its consideration of comments. The
number 0910–0001. The collections of including attachments, to https:// second copy, which will have the
information in the guidance document www.regulations.gov will be posted to claimed confidential information
entitled ‘‘Requests for Feedback on the docket unchanged. Because your redacted/blacked out, will be available
Medical Device Submissions: The Pre- comment will be made public, you are for public viewing and posted on
Submission Program and Meetings with solely responsible for ensuring that your https://www.regulations.gov. Submit
Food and Drug Administration Staff’’ comment does not include any both copies to the Dockets Management
have been approved under OMB control confidential information that you or a Staff. If you do not wish your name and
number 0910–0756. third party may not wish to be posted, contact information to be made publicly
Dated: December 12, 2017. such as medical information, your or available, you can provide this
Leslie Kux, 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
Associate Commissioner for Policy.
as a manufacturing process. Please note must identify this information as
[FR Doc. 2017–27155 Filed 12–15–17; 8:45 am]
that if you include your name, contact ‘‘confidential.’’ Any information marked
BILLING CODE 4164–01–P as ‘‘confidential’’ will not be disclosed
information, or other information that
identifies you in the body of your except in accordance with 21 CFR 10.20
comments, that information will be and other applicable disclosure law. For
DEPARTMENT OF HEALTH AND
posted on https://www.regulations.gov. more information about FDA’s posting
HUMAN SERVICES
• If you want to submit a comment of comments to public dockets, see 80
Food and Drug Administration 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/
[Docket No. FDA–2017–D–6765] fdsys/pkg/FR-2015-09-18/pdf/2015-
public, submit the comment as a
written/paper submission and in the 23389.pdf.
Replacement Reagent and Instrument Docket: For access to the docket to
Family Policy for In Vitro Diagnostic manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’). read background documents or the
Devices; Draft Guidance for Industry electronic and written/paper comments
and Food and Drug Administration Written/Paper Submissions received, go to https://
Staff; Availability www.regulations.gov and insert the
Submit written/paper submissions as
AGENCY: Food and Drug Administration, follows: docket number, found in brackets in the
HHS. • Mail/Hand delivery/Courier (for heading of this document, into the
ACTION: Notice of availability. written/paper submissions): Dockets ‘‘Search’’ box and follow the prompts
Management Staff (HFA–305), Food and and/or go to the Dockets Management
SUMMARY: The Food and Drug Drug Administration, 5630 Fishers Staff, 5630 Fishers Lane, Rm. 1061,
Administration (FDA or Agency) is Lane, Rm. 1061, Rockville, MD 20852. Rockville, MD 20852.
announcing the availability of the draft • For written/paper comments You may submit comments on any
guidance entitled ‘‘Replacement Reagent submitted to the Dockets Management guidance at any time (see 21 CFR
and Instrument Family Policy for In Staff, FDA will post your comment, as 10.115(g)(5)).
Vitro Diagnostic Devices.’’ FDA is well as any attachments, except for An electronic copy of the guidance
issuing this draft guidance document to information submitted, marked and document is available for download
update and clarify the policy for a identified, as confidential, if submitted from the internet. See the
manufacturer’s application of an assay as detailed in ‘‘Instructions.’’ SUPPLEMENTARY INFORMATION section for
that was previously cleared for use Instructions: All submissions received information on electronic access to the
based on performance characteristics must include the Docket No. FDA– guidance. Submit written requests for a
with a specified instrument, to an 2017–D–6765 for ‘‘Replacement Reagent single hard copy of the draft guidance
additional instrument that was and Instrument Family Policy for In document entitled ‘‘Replacement
previously cleared or that is a member Vitro Diagnostic Devices; Draft Reagent and Instrument Family Policy
of an instrument family from which Guidance for Industry and Food and for In Vitro Diagnostic Devices’’ to the
another member has been previously Drug Administration Staff.’’ Received Office of the Center Director, Guidance
cleared. When finalized, this document comments will be placed in the docket and Policy Development, Center for
will supersede ‘‘Replacement Reagent and, except for those submitted as Devices and Radiological Health, Food
and Instrument Family Policy,’’ issued ‘‘Confidential Submissions,’’ publicly and Drug Administration, 10903 New
on December 11, 2003. This draft viewable at https://www.regulations.gov Hampshire Ave., Bldg. 66, Rm. 5431,
guidance is not final nor is it in effect or at the Dockets Management Staff Silver Spring, MD 20993–0002. Send
at this time. between 9 a.m. and 4 p.m., Monday one self-addressed adhesive label to
DATES: Submit either electronic or through Friday. assist that office in processing your
daltland on DSKBBV9HB2PROD with NOTICES
written comments on the draft guidance • Confidential Submissions—To request.
by March 19, 2018 to ensure that the submit a comment with confidential FOR FURTHER INFORMATION CONTACT: Avis
Agency considers your comment on this information that you do not wish to be Danishefsky, Center for Devices and
draft guidance before it begins work on made publicly available, submit your Radiological Health, Food and Drug
the final version of the guidance. comments only as a written/paper Administration, 10903 New Hampshire
ADDRESSES: You may submit comments submission. You should submit two Ave., Bldg. 66, Rm. 5620, Silver Spring,
on any guidances at any time as follows: copies total. One copy will include the MD 20993–0002, 301–796–6142.
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Document Created: 2017-12-15 23:54:59
Document Modified: 2017-12-15 23:54:59
| 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 March 19, 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 | David Litwack, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 4548, Silver Spring, MD 20993-0002, 301-796-6697 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, 240-402-7911. | |
| FR Citation | 82 FR 60022 |
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