[Federal Register Volume 88, Number 59 (Tuesday, March 28, 2023)]
[Notices]
[Pages 18321-18322]
[FR Doc No: 2023-06254]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-3419]

General Considerations for Animal Studies Intended To Evaluate
Medical Devices; Guidance for Industry and Food and Drug Administration
Staff; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``General Considerations
for Animal Studies Intended to Evaluate Medical Devices.'' FDA
developed this guidance document to assist medical device sponsors,
testing facilities, and other persons involved in designing,
conducting, and reporting the results of animal studies intended to
assess the safety of medical devices to support premarket submissions.
These animal studies typically provide initial evidence of device
safety, which may include device performance and handling, and the
biological effects when used in a living system.

DATES: The announcement of the guidance is published in the Federal
Register on March 28, 2023.

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 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-2015-D-3419 for ``General Considerations for Animal Studies
Intended to Evaluate Medical Devices.'' 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,<PHONE_NUMBER>.
     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.govinfo.gov/content/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,<PHONE_NUMBER>.
    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 guidance document entitled
``General Considerations for Animal Studies Intended to Evaluate
Medical Devices'' to the Office of Policy, 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: Judith A. Davis, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 2220, Silver Spring, MD 20993-0002, 301-
796-6636.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA developed this guidance document to assist medical device
sponsors, testing facilities, and other persons involved in designing,
conducting, and reporting the results of animal studies intended to
support the safety of medical devices for premarket submissions. These
animal studies typically provide initial evidence of device safety,
which may include their performance and handling, and the biological
effects when used in a living system. This guidance outlines general
considerations for certain animal studies used to support device
premarket submissions, when a suitable alternative to an animal study
is not available. This guidance provides recommendations on study
planning,

including selecting an appropriate animal model; study monitoring; and
study evaluation. The document also provides recommendations on test
facility selection, animal housing, and records and reports, including
animal study reports for premarket submissions. This guidance
supersedes the final guidance ``General Considerations for Animal
Studies for Cardiovascular Devices,'' issued on July 28, 2010.
    A notice of availability of the draft guidance appeared in the
Federal Register of October 14, 2015 (80 FR 61820). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including increased emphasis of the 3Rs to reduce,
refine, and replace animal use in testing when feasible, reorganization
of the guidance to better represent the study design, conduct, and
reporting process, clarification of important terminology, and
technical edits.
    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 general considerations for animal Studies
intended to evaluate medical devices. 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.

II. Electronic Access

    Persons interested in obtaining a copy of the 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/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov or https://www.fda.gov/regulatory-information/search-fda-guidance-documents. Persons unable to
download an electronic copy of ``General Considerations for Animal
Studies Intended to Evaluate Medical Devices'' may send an email
request to [email protected] to receive an electronic copy of
the document. Please use the document number GUI00001802 and complete
title to identify the guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
                                                           OMB  control
21 CFR part; guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
807, subpart E....................  Premarket                  0910-0120
                                     notification.
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Device        0910-0332
                                     Exemption.
812...............................  Investigational            0910-0078
                                     Device Exemption.
``De Novo Classification Process    De Novo                    0910-0844
 (Evaluation of Automatic Class      classification
 III Designation)''.                 process.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice (CGMP);
                                     Quality System (QS)
                                     Regulation.
58................................  Good Laboratory            0910-0119
                                     Practice (GLP)
                                     Regulations for
                                     Nonclinical
                                     Laboratory Studies.
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    Dated: March 21, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-06254 Filed 3-27-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 86, Number 103 (Tuesday, June 1, 2021)]
[Notices]
[Page 29257]
[FR Doc No: 2021-11469]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER21-1988-000]

SP Garland Solar Storage, LLC; Supplemental Notice That Initial
Market-Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
SP Garland Solar Storage, LLC's application for market-based rate
authority, with an accompanying rate tariff, noting that such
application includes a request for blanket authorization, under 18 CFR
part 34, of future issuances of securities and assumptions of
liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 14, 2021.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically may mail similar pleadings to
the Federal Energy Regulatory Commission, 888 First Street NE,
Washington, DC 20426. Hand delivered submissions in docketed
proceedings should be delivered to Health and Human Services, 12225
Wilkins Avenue, Rockville, Maryland 20852.
    In addition to publishing the full text of this document in the
Federal Register, the Commission provides all interested persons an
opportunity to view and/or print the contents of this document via the
internet through the Commission's Home Page (http://www.ferc.gov) using
the ``eLibrary'' link. Enter the docket number excluding the last three
digits in the docket number field to access the document. At this time,
the Commission has suspended access to the Commission's Public
Reference Room, due to the proclamation declaring a National Emergency
concerning the Novel Coronavirus Disease (COVID-19), issued by the
President on March 13, 2020. For assistance, contact the Federal Energy
Regulatory Commission at<EMAIL_ADDRESS>or call toll-free,
(886) 208-3676 or TTY,<PHONE_NUMBER>.

    Dated: May 25, 2021.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2021-11469 Filed 5-28-21; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Notices]
[Pages 26494-26495]
[FR Doc No: 2017-11820]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-2094]

Developing Rabies Monoclonal Antibody Products as a Component of
Rabies Post-Exposure Prophylaxis; Public Workshop; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public workshop; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing a public workshop regarding development of rabies monoclonal
antibody products to be used in conjunction with licensed rabies
vaccine as part of a rabies post-exposure prophylaxis (PEP) regimen.
This public workshop is intended to provide information for, and gain
perspective from, health care providers, other U.S. Government
Agencies, academic experts, industry, and other stakeholders on various
aspects of development efforts pertaining to animal models, laboratory
assays, and clinical trials.

DATES: The public workshop will be held on July 17, 2017, from 8:30
a.m. to 5 p.m. Submit either electronic or written comments on this
public workshop on or before July 31, 2017. See the SUPPLEMENTARY
INFORMATION section for registration date and information. The workshop
draft Agenda will be made available at: http://www.fda.gov/Drugs/NewsEvents/ucm540832.htm prior to the meeting.

ADDRESSES: The public workshop will be held at FDA's White Oak Campus,
10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
(Rm. 1503), Silver Spring, MD 20993. Entrance for the public workshop
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.
    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 July 31, 2017. The https://www.regulations.gov
electronic filing system will accept comments until midnight Eastern
Time at the end of July 31, 2017. 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

    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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of
Dockets Management, 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-2017-N-2094 for ``Developing Rabies Monoclonal Antibody Products as
a Component of Rabies Post-Exposure Prophylaxis.'' Received comments,
those filed in a timely manner (see ADDRESSES), will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Division of
Dockets Management 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 Division of Dockets Management. 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 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 Division of Dockets Management, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Lori Benner and/or Jessica Barnes,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 22, Rm. 6221, Silver Spring, MD 20993-
0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing a public workshop regarding development of rabies
monoclonal antibody products to be used in conjunction with a licensed
rabies vaccine as part of rabies PEP. Rabies immunoglobulin, in
combination with rabies vaccine, is currently recommended for rabies
PEP following suspected or proven rabies exposure. Rabies monoclonal
antibody products may offer a potential alternative to rabies
immunoglobulin as a component of rabies PEP.

II. Topics for Discussion at the Public Workshop

    FDA is conducting this workshop to discuss the scientific work
needed to advance the development of rabies monoclonal antibodies
targeting rabies viruses for use in a PEP regimen. Discussions are
planned around the following topics:

 Rabies epidemiology and vectors
 Current rabies PEP standard of care
 Scientific challenges of assessing the likely effects of
rabies monoclonal antibodies
 Potential utility of animal models and laboratory assays in
rabies monoclonal antibody development
 Clinical trial design challenges related to the scientific
evaluation of rabies monoclonal antibody efficacy as a component of
rabies PEP
 Ethical considerations regarding potential clinical trial
designs
    The Agency encourages health care providers, other U.S. Government
Agencies, academic experts, industry, and other stakeholders to attend
this public workshop.

III. Participating in the Public Workshop

    Registration: Registration is free and based on space availability,
with priority given to early registrants. Persons interested in
attending this public workshop must register by July 12, 2017, midnight
Eastern Time. To register, please provide complete contact information
for each attendee, including name, title, affiliation, address, email,
and telephone to<EMAIL_ADDRESS>Early registration is
recommended because seating is limited; therefore, FDA may limit the
number of participants from each organization. Registrants will receive
confirmation when they have been accepted. If time and space permit,
onsite registration on the day of the public workshop will be provided
beginning at 7:30 a.m. We will let registrants know if registration
closes before the day of the public workshop.
    If you need special accommodations due to a disability, please
contact Jessica Barnes or Lori Benner (see FOR FURTHER INFORMATION
CONTACT) no later than July 12, 2017.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session and
which topic(s) you wish to address. We will do our best to accommodate
requests to make public comments. Individuals and organizations with
common interests are urged to consolidate or coordinate their
presentations, and request time for a joint presentation. Following the
close of registration, we will determine the amount of time allotted to
each presenter and the approximate time each oral presentation is to
begin, and will select and notify participants by July 11, 2017. All
requests to make oral presentations must be received by July 10, 2017,
midnight Eastern Time. If selected for presentation, any presentation
materials must be emailed to<EMAIL_ADDRESS>no later
than July 13, 2017. No commercial or promotional material will be
permitted to be presented or distributed at the public workshop.
    Streaming Webcast of the public workshop: This public workshop will
also be Webcast at the following Web site: https://collaboration.fda.gov/r6811zievzz/.
    If you have never attended a Connect Pro event before, please test
your connection at https://collaboration.fda.gov/common/help/en/support/meeting_test.htm. To get a quick overview of the Connect Pro
program, visit https://www.adobe.com/go/connectpro_overview. FDA has
verified the Web site addresses in this document, as of the date this
document publishes in the Federal Register, but Web sites are subject
to change over time.
    Transcripts: Please be advised that as soon as a transcript of the
public workshop is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Division of Dockets
Management (see ADDRESSES). A link to the transcript will also be
available on the Internet at http://www.fda.gov/Drugs/NewsEvents/ucm540832.htm approximately 45 days after the workshop.

    Dated: May 31, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-11820 Filed 6-6-17; 8:45 am]
BILLING CODE 4164-01-P