Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability, 34909-34910 [2015-14982]

Download as PDF Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Notices FEDERAL RESERVE SYSTEM DEPARTMENT OF HEALTH AND HUMAN SERVICES Formations of, Acquisitions by, and Mergers of Bank Holding Companies Food and Drug Administration The companies listed in this notice have applied to the Board for approval, pursuant to the Bank Holding Company Act of 1956 (12 U.S.C. 1841 et seq.) (BHC Act), Regulation Y (12 CFR part 225), and all other applicable statutes and regulations to become a bank holding company and/or to acquire the assets or the ownership of, control of, or the power to vote shares of a bank or bank holding company and all of the banks and nonbanking companies owned by the bank holding company, including the companies listed below. The applications listed below, as well as other related filings required by the Board, are available for immediate inspection at the Federal Reserve Bank indicated. The applications will also be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing on the standards enumerated in the BHC Act (12 U.S.C. 1842(c)). If the proposal also involves the acquisition of a nonbanking company, the review also includes whether the acquisition of the nonbanking company complies with the standards in section 4 of the BHC Act (12 U.S.C. 1843). Unless otherwise noted, nonbanking activities will be conducted throughout the United States. Unless otherwise noted, comments regarding each of these applications must be received at the Reserve Bank indicated or the offices of the Board of Governors not later than July 13, 2015. A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President) 1 Memorial Drive, Kansas City, Missouri 64198–0001: 1. Southwest Bancorp, Inc., Stillwater, Oklahoma; to acquire 100 percent of the voting shares of First Commercial Bancshares, Inc., and thereby indirectly acquire voting shares of First Commercial Bank, both in Edmond, Oklahoma. tkelley on DSK3SPTVN1PROD with NOTICES Board of Governors of the Federal Reserve System, June 15, 2015. Michael J. Lewandowski, Associate Secretary of the Board. [FR Doc. 2015–14985 Filed 6–17–15; 8:45 am] BILLING CODE 6210–01–P VerDate Sep<11>2014 16:53 Jun 17, 2015 Jkt 235001 [Docket No. FDA–2015–D–1777] Factors To Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions; Draft Guidance for Investigational Device Exemption Sponsors, Sponsor-Investigators, and Food and Drug Administration Staff; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ‘‘Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs).’’ The purpose of this draft guidance is to provide greater clarity for FDA staff and IDE sponsors and sponsor-investigators regarding the principal factors that FDA considers when assessing the benefits and risks of IDE applications for human clinical study. The draft guidance also characterizes benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent they are indirect benefits to subjects or reflect the importance of knowledge to be gained). This draft guidance is not final nor is it in effect at this time. DATES: Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment of this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by September 16, 2015. ADDRESSES: 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 entitled ‘‘Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs)’’ 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 SUMMARY: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 34909 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. Submit electronic comments on the draft guidance to https:// www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Sugato De, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5435, Silver Spring, MD 20993–0002, 301–796–6270; 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 A primary goal of this guidance is to clarify the factors that FDA considers when assessing risks and anticipated benefits for IDE studies, and how uncertainty may be offset by a variety of risk mitigation measures that can assure appropriate patient and participant protections in investigational research settings. At earlier stages of device development, FDA considers appropriate mitigation measures for anticipated possible risks and unanticipated risks, whereas in later stages, risk mitigation focuses increasingly on the most probable risks. Another important goal of this guidance is to characterize benefits in the context of investigational research, which includes direct benefits to the subjects and benefits to others (to the extent they are indirect benefits to subjects or reflect the importance of knowledge to be gained). As with the benefit-risk framework for evaluating marketing applications, FDA assessment of benefits and risks for an IDE application takes into account the contextual setting in which the study is being proposed, including but not limited to characterization of the disease or condition being treated or diagnosed, the availability of alternative treatments or diagnostics, and the risks associated with them. When available, information characterizing subject tolerance for risk E:\FR\FM\18JNN1.SGM 18JNN1 34910 Federal Register / Vol. 80, No. 117 / Thursday, June 18, 2015 / Notices and perspective on benefit may provide useful context during this assessment. FDA believes use of this benefit-risk framework in an IDE application will facilitate the incorporation of evidence and knowledge from different domains—clinical, nonclinical, and patient—to support a comprehensive, balanced decision-making approach. FDA envisions this will facilitate a common understanding between FDA and sponsors/sponsor-investigators by highlighting which factors are critical in the benefit-risk assessment for a specific application, and clearly explaining how these factors influence a regulatory decision. FDA also believes implementation of this guidance document will improve the predictability, consistency, and transparency of the review process for IDE applications. 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 ‘‘Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions (IDEs).’’ It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. tkelley on DSK3SPTVN1PROD with NOTICES 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. Guidance documents are also available at https://www.regulations.gov or from CBER at https://www.fda.gov/Biologics BloodVaccines/GuidanceCompliance RegulatoryInformation/default.htm. Persons unable to download an electronic copy of ‘‘Factors to Consider When Making Benefit-Risk Determinations for Medical Device Investigational Device Exemptions’’ may send an email request to CDRHGuidance@fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1783 to identify the guidance you are requesting. VerDate Sep<11>2014 16:53 Jun 17, 2015 Jkt 235001 IV. Paperwork Reduction Act of 1995 This draft guidance refers to previously approved collections of information found in FDA regulations. 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 812 have been approved under OMB control number 0910–0078; the collections of information in 21 CFR part 50.23 (Exception from general requirements for informed consent) have been approved under OMB control number 0910–0586; the collections of information in 21 CFR part 56.115 (IRB records) have been approved under OMB control number 0910–0130; and the collections of information in 21 CFR part 50, subpart B (Informed Consent of Human Subjects) and 56 (Institutional Review Boards) have been approved under OMB control number 0910–0755. V. Comments Interested persons may submit either electronic comments regarding this document to https://www.regulations.gov or written comments to the Division of Dockets Management (see ADDRESSES). It is only necessary to send one set of comments. Identify comments with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday, and will be posted to the docket at https:// www.regulations.gov. Dated: June 12, 2015. Leslie Kux, Associate Commissioner for Policy. [FR Doc. 2015–14982 Filed 6–17–15; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2015–N–1968] Non-Microbial Biomarkers of Infection for In Vitro Diagnostic Device Use; Public Workshop; Request for Comments AGENCY: Food and Drug Administration, HHS. Notice of public workshop; request for comments. ACTION: The Food and Drug Administration (FDA) is announcing the following public workshop entitled ‘‘Non-Microbial Biomarkers of Infection SUMMARY: PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 for In Vitro Diagnostic Device Use.’’ The purpose of this workshop is to receive input from stakeholders and discuss approaches to the study of nonmicrobial biomarkers for differentiating viral from bacterial infections and for diagnosis and assessment of sepsis. Comments and suggestions generated through this workshop will facilitate further development of regulatory science for establishing appropriate comparator methods and clinically relevant performance standards for nonmicrobial based in vitro diagnostics for infection. DATES: The public workshop will be held on October 16, 2015, from 8 a.m. to 5 p.m. Registration to attend the meeting must be made by 4 p.m. on October 6, 2015. Registration from those individuals interested in presenting comments should be received by September 16, 2015. See the SUPPLEMENTARY INFORMATION section for instructions on how to register for the meeting. Submit either electronic or written comments by 4 p.m. on November 13, 2015. ADDRESSES: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (Rm. 1503), Silver Spring, MD 20993. Entrance for the public meeting participants (non-FDA employees) is through Building 1 where routine security check procedures will be performed. For parking and security information, please refer to https:// www.fda.gov/AboutFDA/ WorkingatFDA/BuildingsandFacilities/ WhiteOakCampusInformation/ ucm241740.htm. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Natasha Townsend, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5525, Silver Spring, MD 20993–0002, 301–796–5927, FAX: 301–847–2512, email: natasha.townsend@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background There has been increasing interest in the development of non-microbiological biomarkers to aid in determining whether patient signs and symptoms consistent with infection are attributable to an infectious or non-infectious cause, E:\FR\FM\18JNN1.SGM 18JNN1

Agencies

[Federal Register Volume 80, Number 117 (Thursday, June 18, 2015)]
[Notices]
[Pages 34909-34910]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-14982]


=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-1777]


Factors To Consider When Making Benefit-Risk Determinations for 
Medical Device Investigational Device Exemptions; Draft Guidance for 
Investigational Device Exemption Sponsors, Sponsor-Investigators, and 
Food and Drug Administration Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of the draft guidance entitled ``Factors to Consider When 
Making Benefit-Risk Determinations for Medical Device Investigational 
Device Exemptions (IDEs).'' The purpose of this draft guidance is to 
provide greater clarity for FDA staff and IDE sponsors and sponsor-
investigators regarding the principal factors that FDA considers when 
assessing the benefits and risks of IDE applications for human clinical 
study. The draft guidance also characterizes benefits in the context of 
investigational research, which includes direct benefits to the 
subjects and benefits to others (to the extent they are indirect 
benefits to subjects or reflect the importance of knowledge to be 
gained). This draft guidance is not final nor is it in effect at this 
time.

DATES: Although you can comment on any guidance at any time (see 21 CFR 
10.115(g)(5)), to ensure that the Agency considers your comment of this 
draft guidance before it begins work on the final version of the 
guidance, submit either electronic or written comments on the draft 
guidance by September 16, 2015.

ADDRESSES: 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 entitled 
``Factors to Consider When Making Benefit-Risk Determinations for 
Medical Device Investigational Device Exemptions (IDEs)'' 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.
    Submit electronic comments on the draft guidance to https://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Sugato De, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 5435, Silver Spring, MD 20993-0002, 301-796-6270; 
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

    A primary goal of this guidance is to clarify the factors that FDA 
considers when assessing risks and anticipated benefits for IDE 
studies, and how uncertainty may be offset by a variety of risk 
mitigation measures that can assure appropriate patient and participant 
protections in investigational research settings. At earlier stages of 
device development, FDA considers appropriate mitigation measures for 
anticipated possible risks and unanticipated risks, whereas in later 
stages, risk mitigation focuses increasingly on the most probable 
risks. Another important goal of this guidance is to characterize 
benefits in the context of investigational research, which includes 
direct benefits to the subjects and benefits to others (to the extent 
they are indirect benefits to subjects or reflect the importance of 
knowledge to be gained).
    As with the benefit-risk framework for evaluating marketing 
applications, FDA assessment of benefits and risks for an IDE 
application takes into account the contextual setting in which the 
study is being proposed, including but not limited to characterization 
of the disease or condition being treated or diagnosed, the 
availability of alternative treatments or diagnostics, and the risks 
associated with them. When available, information characterizing 
subject tolerance for risk

[[Page 34910]]

and perspective on benefit may provide useful context during this 
assessment.
    FDA believes use of this benefit-risk framework in an IDE 
application will facilitate the incorporation of evidence and knowledge 
from different domains--clinical, nonclinical, and patient--to support 
a comprehensive, balanced decision-making approach. FDA envisions this 
will facilitate a common understanding between FDA and sponsors/
sponsor-investigators by highlighting which factors are critical in the 
benefit-risk assessment for a specific application, and clearly 
explaining how these factors influence a regulatory decision. FDA also 
believes implementation of this guidance document will improve the 
predictability, consistency, and transparency of the review process for 
IDE applications.

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 ``Factors to 
Consider When Making Benefit-Risk Determinations for Medical Device 
Investigational Device Exemptions (IDEs).'' It does not create or 
confer any rights for or on any person and does not operate to bind FDA 
or the public. An alternative approach may be used if such approach 
satisfies the requirements of the applicable statute and regulations.

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. Guidance 
documents are also available at https://www.regulations.gov or from CBER 
at https://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/default.htm. Persons unable to 
download an electronic copy of ``Factors to Consider When Making 
Benefit-Risk Determinations for Medical Device Investigational Device 
Exemptions'' may send an email request to CDRH-Guidance@fda.hhs.gov to 
receive an electronic copy of the document. Please use the document 
number 1783 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of 
information found in FDA regulations. 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 812 have been approved under 
OMB control number 0910-0078; the collections of information in 21 CFR 
part 50.23 (Exception from general requirements for informed consent) 
have been approved under OMB control number 0910-0586; the collections 
of information in 21 CFR part 56.115 (IRB records) have been approved 
under OMB control number 0910-0130; and the collections of information 
in 21 CFR part 50, subpart B (Informed Consent of Human Subjects) and 
56 (Institutional Review Boards) have been approved under OMB control 
number 0910-0755.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to https://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at https://www.regulations.gov.

    Dated: June 12, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-14982 Filed 6-17-15; 8:45 am]
BILLING CODE 4164-01-P

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