Implanted Brain-Computer Interface Devices for Patients With Paralysis or Amputation-Nonclinical Testing and Clinical Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability, 6007-6009 [2019-03144]

Download as PDF Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Notices 6007 TABLE 1—NEW DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS—Continued Ozenoxacin. Paroxetine mesylate. Succimer. III. Drug Products For Which Revised Draft Product-Specific Guidances Are Available for industry for drug products containing the following active ingredients: FDA is announcing the availability of revised draft product-specific guidances TABLE 2—REVISED DRAFT PRODUCT-SPECIFIC GUIDANCES FOR DRUG PRODUCTS amozie on DSK3GDR082PROD with NOTICES1 Acetaminophen; Butalbital. Aripiprazole. Azelastine HCl; Fluticasone propionate. Betamethasone Dipropionate; Calcipotriene Hydrate (multiple Reference Listed Drugs). Betamethasone Dipropionate; Clotrimazole (multiple Reference Listed Drugs). Butenafine HCl (multiple Reference Listed Drugs). Butoconazole nitrate (multiple Reference Listed Drugs). Calcipotriene (multiple Reference Listed Drugs). Ceritinib. Ciclopirox (multiple Reference Listed Drugs). Clotrimazole (multiple Reference Listed Drugs). Crisaborole. Dexamethasone; Tobramycin (multiple Reference Listed Drugs). Diclofenac sodium. Econazole nitrate. Fluorouracil (multiple Reference Listed Drugs). Fluticasone propionate. Haloperidol. Imiquimod (multiple Reference Listed Drugs). Ingenol mebutate (multiple Reference Listed Drugs). Ketoconazole. Lumacaftor; Ivacaftor. Miconazole. Mometasone furoate monohydrate (multiple Reference Listed Drugs). Oxiconazole Nitrate (multiple Reference Listed Drugs). Tazarotene (multiple Reference Listed Drugs). Terbinafine hydrochloride. Treprostinil diethanolamine (multiple Reference Listed Drugs). Tretinoin. Triamcinolone acetonide. For a complete history of previously published Federal Register documents related to product-specific guidances, go to https://www.regulations.gov and enter Docket No. FDA–2007–D–0369. These draft guidances are being issued consistent with FDA’s good guidance practices regulation (21 CFR 10.115). These draft guidances, when finalized, will represent the current thinking of FDA on, among other things, the product-specific design of BE studies to support ANDAs. They do not establish any rights for any person and are 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. http://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ Guidances/default.htm or https:// www.regulations.gov. DEPARTMENT OF HEALTH AND HUMAN SERVICES Dated: February 19, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [Docket No. FDA–2014–N–1130] [FR Doc. 2019–03129 Filed 2–22–19; 8:45 am] BILLING CODE 4164–01–P Jkt 247001 PO 00000 Food and Drug Administration, HHS. ACTION: Notice of availability. The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled ‘‘Implanted BrainComputer Interface Devices for Patients with Paralysis or Amputation— Nonclinical Testing and Clinical SUMMARY: Persons with access to the internet may obtain the draft guidances at either 16:22 Feb 22, 2019 Implanted Brain-Computer Interface Devices for Patients With Paralysis or Amputation—Nonclinical Testing and Clinical Considerations; Draft Guidance for Industry and Food and Drug Administration Staff; Availability AGENCY: IV. Electronic Access VerDate Sep<11>2014 Food and Drug Administration Frm 00029 Fmt 4703 Sfmt 4703 E:\FR\FM\25FEN1.SGM 25FEN1 6008 Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Notices Considerations.’’ Implanted braincomputer interface (BCI) devices are neuroprostheses that interface with the central or peripheral nervous system to restore lost motor and/or sensory capabilities in patients with paralysis or amputation. This draft guidance provides recommendations for nonclinical testing and study design considerations for investigational device exemptions feasibility and pivotal clinical studies. 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 April 26, 2019 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: amozie on DSK3GDR082PROD with NOTICES1 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.’’ VerDate Sep<11>2014 16:22 Feb 22, 2019 Jkt 247001 Instructions: All submissions received must include the Docket No. FDA– 2014–N–1130 for ‘‘Implanted BrainComputer Interface Devices for Patients with Paralysis or Amputation— Nonclinical Testing and Clinical Considerations.’’ 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/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)). 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 PO 00000 Frm 00030 Fmt 4703 Sfmt 4703 guidance. Submit written requests for a single hard copy of the draft guidance document entitled ‘‘Implanted BrainComputer Interface Devices for Patients with Paralysis or Amputation— Nonclinical Testing and Clinical Considerations’’ 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. Send one selfaddressed adhesive label to assist that office in processing your request. FOR FURTHER INFORMATION CONTACT: Vivek Pinto, Center for Devices and Radiological Health, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2668, Silver Spring, MD 20993–0002, 301–796–1136. SUPPLEMENTARY INFORMATION: I. Background The field of implanted BCI devices is progressing rapidly from fundamental neuroscience discoveries to translational applications and market access. Implanted BCI devices have the potential to bring benefit to people with severe disabilities by increasing their ability to interact with their environment, and consequently, providing new independence in daily life. On November 21, 2014, the Center for Devices and Radiological Health (CDRH) held an open public workshop with the aim of fostering an open discussion on the scientific and clinical considerations associated with the development of implanted BCI devices. FDA considered the input provided during this workshop to develop this guidance document. This guidance document provides clinical study design and nonclinical testing recommendations associated with BCI devices. This is a leapfrog guidance: A type of guidance that serves as a mechanism by which the Agency can share initial thoughts regarding emerging technologies that are likely to be of public health importance early in product development. This leapfrog guidance represents the Agency’s initial thinking and our recommendations may change as more information becomes available. 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 current thinking of FDA on implanted BCI devices for patients with paralysis or amputation— E:\FR\FM\25FEN1.SGM 25FEN1 Federal Register / Vol. 84, No. 37 / Monday, February 25, 2019 / Notices nonclinical testing and clinical considerations. 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 CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/ DeviceRegulationandGuidance/ GuidanceDocuments/default.htm. This guidance document is also available at https://www.regulations.gov. Persons unable to download an electronic copy of ‘‘Implanted Brain-Computer Interface Devices for Patients with Paralysis or Amputation—Nonclinical Testing and Clinical Considerations’’ may send an email request to CDRH-Guidance@ fda.hhs.gov to receive an electronic copy of the document. Please use the document number 1500045 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 and guidance. 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 the following FDA regulations and guidance have been approved by OMB as listed in the following table: OMB control No. 21 CFR part or guidance Topic 812 .............................................................................................. ‘‘Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff’’. 801 .............................................................................................. 820 .............................................................................................. Investigational Device Exemption .............................................. Q-submissions ........................................................................... 0910–0078 0910–0756 Medical Device Labeling Regulations ........................................ Current Good Manufacturing Practice (CGMP); Quality System (QS) Regulation. Protection of Human Subjects: Informed Consent; Institutional Review Boards. 0910–0485 0910–0073 50, 56 .......................................................................................... Dated: February 14, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019–03144 Filed 2–22–19; 8:45 am] BILLING CODE 4164–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2013–N–1425] Agency Information Collection Activities; Proposed Collection; Comment Request; Focused Mitigation Strategies To Protect Food Against Intentional Adulteration AGENCY: Food and Drug Administration, HHS. ACTION: The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on collections of information describing mitigation VerDate Sep<11>2014 16:22 Feb 22, 2019 strategies to protect food against intentional adulteration. DATES: Submit either electronic or written comments on the collection of information by April 26, 2019. ADDRESSES: You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before April 26, 2019. The https://www.regulations.gov electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of April 26, 2019. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date. Electronic Submissions Notice. SUMMARY: amozie on DSK3GDR082PROD with NOTICES1 6009 Jkt 247001 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 PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 0910–0755 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– 2013–N–1425 for ‘‘Agency Information Collection Activities; Proposed Collection; Comment Request; Focused Mitigation Strategies to Protect Food Against Intentional Adulteration.’’ Received comments, those filed in a timely manner (see ADDRESSES), will be placed in the docket and, except for those submitted as ‘‘Confidential E:\FR\FM\25FEN1.SGM 25FEN1

Agencies

[Federal Register Volume 84, Number 37 (Monday, February 25, 2019)]
[Notices]
[Pages 6007-6009]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-03144]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-N-1130]


Implanted Brain-Computer Interface Devices for Patients With 
Paralysis or Amputation--Nonclinical Testing and Clinical 
Considerations; Draft Guidance for Industry and Food and Drug 
Administration Staff; 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 ``Implanted Brain-
Computer Interface Devices for Patients with Paralysis or Amputation--
Nonclinical Testing and Clinical

[[Page 6008]]

Considerations.'' Implanted brain-computer interface (BCI) devices are 
neuroprostheses that interface with the central or peripheral nervous 
system to restore lost motor and/or sensory capabilities in patients 
with paralysis or amputation. This draft guidance provides 
recommendations for nonclinical testing and study design considerations 
for investigational device exemptions feasibility and pivotal clinical 
studies. 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 April 26, 2019 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-2014-N-1130 for ``Implanted Brain-Computer Interface Devices for 
Patients with Paralysis or Amputation--Nonclinical Testing and Clinical 
Considerations.'' 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)).
    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 
``Implanted Brain-Computer Interface Devices for Patients with 
Paralysis or Amputation--Nonclinical Testing and Clinical 
Considerations'' 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. Send one self-addressed adhesive label to 
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Vivek Pinto, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2668, Silver Spring, MD 20993-0002, 301-796-1136.

SUPPLEMENTARY INFORMATION:

I. Background

    The field of implanted BCI devices is progressing rapidly from 
fundamental neuroscience discoveries to translational applications and 
market access. Implanted BCI devices have the potential to bring 
benefit to people with severe disabilities by increasing their ability 
to interact with their environment, and consequently, providing new 
independence in daily life. On November 21, 2014, the Center for 
Devices and Radiological Health (CDRH) held an open public workshop 
with the aim of fostering an open discussion on the scientific and 
clinical considerations associated with the development of implanted 
BCI devices. FDA considered the input provided during this workshop to 
develop this guidance document. This guidance document provides 
clinical study design and nonclinical testing recommendations 
associated with BCI devices.
    This is a leapfrog guidance: A type of guidance that serves as a 
mechanism by which the Agency can share initial thoughts regarding 
emerging technologies that are likely to be of public health importance 
early in product development. This leapfrog guidance represents the 
Agency's initial thinking and our recommendations may change as more 
information becomes available.

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 current thinking of FDA on implanted BCI 
devices for patients with paralysis or amputation--

[[Page 6009]]

nonclinical testing and clinical considerations. 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 CDRH guidance documents is available at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. This guidance document is also available 
at https://www.regulations.gov. Persons unable to download an 
electronic copy of ``Implanted Brain-Computer Interface Devices for 
Patients with Paralysis or Amputation--Nonclinical Testing and Clinical 
Considerations'' may send an email request to CDRH-Guidance@fda.hhs.gov 
to receive an electronic copy of the document. Please use the document 
number 1500045 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 and guidance. 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 the following FDA regulations 
and guidance have been approved by OMB as listed in the following 
table:

------------------------------------------------------------------------
                                                            OMB control
    21 CFR part or guidance               Topic                 No.
------------------------------------------------------------------------
812............................  Investigational Device        0910-0078
                                  Exemption.
``Requests for Feedback on       Q-submissions..........       0910-0756
 Medical Device Submissions:
 The Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
801............................  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
50, 56.........................  Protection of Human           0910-0755
                                  Subjects: Informed
                                  Consent; Institutional
                                  Review Boards.
------------------------------------------------------------------------


    Dated: February 14, 2019.
Lowell J. Schiller,
Acting Associate Commissioner for Policy.
[FR Doc. 2019-03144 Filed 2-22-19; 8:45 am]
 BILLING CODE 4164-01-P