[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50047-50048]
[FR Doc No: 2019-20593]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-D-3846]

Patient Engagement in the Design and Conduct of Medical Device
Clinical Investigations; Draft Guidance for Industry, Food and Drug
Administration Staff, and Other Stakeholders; 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the availability of the draft guidance entitled ``Patient Engagement in
the Design and Conduct of Medical Device Clinical Investigations.'' The
Patient Engagement Advisory Committee (PEAC) recommended that FDA and
industry develop some type of framework to clarify how patient advisors
can engage in the clinical investigation process. This draft guidance
focuses on the applications, perceived barriers, and common challenges
of patient engagement in the design and conduct of medical device
clinical 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 This draft guidance is not final nor is it in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DATES: Submit either electronic or written comments on the draft
guidance by November 25, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2019-D-3846 for ``Patient Engagement in the Design and Conduct of
Medical Device Clinical Investigations.'' 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
``Patient Engagement in the Design and Conduct of Clinical
Investigations'' to the Office of Policy, 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 to 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: Mimi Nguyen, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5437, Silver Spring, MD 20993-0002,<PHONE_NUMBER>;
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,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    On October 11 and 12, 2017, the PEAC met to discuss and make
recommendations regarding patient engagement into medical device
clinical investigations. The PEAC stated that some framework should be
developed by FDA and industry to clarify how patient advisors can
engage in the clinical investigation process. Based on this
recommendation, FDA is pursuing various efforts of patient engagement
in clinical trials, including guidance. FDA believes medical device
clinical investigations designed with patient input may help to address
common challenges faced in medical device clinical investigations.
    While FDA acknowledges that patient engagement may be beneficial
across the total product lifecycle, this draft guidance focuses on the
applications of patient engagement in the design and conduct of medical
device clinical investigations.

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 ``Patient
Engagement in the Design and Conduct of Clinical Investigations.'' 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/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/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances. Persons unable to download an electronic
copy of ``Patient Engagement in the Design and Conduct of Clinical
Investigations'' may send an email request to<EMAIL_ADDRESS>to receive an electronic copy of the document. Please use the document
number 18040 to identify the guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This draft guidance refers to previously 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
the following FDA regulations, guidance, and forms have been approved
by OMB as listed in the following table:

------------------------------------------------------------------------
  21 CFR part; guidance; or FDA
              form                       Topic          OMB control 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        Q-submissions......          0910-0756
 Medical Device Submissions: The
 Pre-Submission Program and
 Meetings with Food and Drug
 Administration Staff''.
50, 56..........................  Protection of Human          0910-0755
                                   Subjects: Informed
                                   Consent;
                                   Institutional
                                   Review Boards.
56..............................  Institutional                0910-0130
                                   Review Boards.
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    Dated: September 18, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20593 Filed 9-23-19; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 88, Number 152 (Wednesday, August 9, 2023)]
[Notices]
[Pages 53877-53878]
[FR Doc No: 2023-17063]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC23-12-000]

Commission Information Collection Activities (Ferc-521); Comment
Request; Extension

AGENCY: Federal Energy Regulatory Commission, Department of Energy.

ACTION: Notice of information collection and request for comments.

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SUMMARY: In compliance with the requirements of the Paperwork Reduction
Act of 1995 (PRA), the Federal Energy Regulatory Commission (Commission
or FERC) is soliciting public comment on FERC-521 (Payments for
Benefits from Headwater Improvements).

DATES: Comments on the collection of information are due September 8,
2023.

ADDRESSES: Send written comments on FERC-521 to OMB through
www.reginfo.gov/public/do/PRAMain, Attention: Federal Energy Regulatory
Commission Desk Officer. Please identify the OMB Control Number 1902-
0087 (Payments for Benefits from Headwater Improvements) in the subject
line. Your comments should be sent within 30 days of publication of
this notice in the Federal Register.
    Please submit copies of your comments (identified by Docket No.
IC23-12-000 and the form) to the Commission as noted below. Electronic
filing through https://www.ferc.gov, is preferred.
     Electronic Filing: Documents must be filed in acceptable
native applications and print-to-PDF, but not in scanned or picture
format.
     For those unable to file electronically, comments may be
filed by USPS mail or by hand (including courier) delivery.
    [cir] Mail via U.S. Postal Service only, addressed to: Federal
Energy Regulatory Commission, Secretary of the Commission, 888 First
Street NE, Washington, DC 20426.
    [cir] Mail via any other service (including courier delivery):
Federal Energy Regulatory Commission, Secretary of the Commission,
12225 Wilkins Avenue, Rockville, MD 20852.
    Please reference the specific collection number(s) and/or title(s)
in your comments.
    Instructions: OMB submissions must be formatted and filed in
accordance with submission guidelines at: www.reginfo.gov/public/do/PRAMain. Using the search function under the ``Currently Under Review
field,'' select Federal Energy Regulatory Commission; click ``submit''
and select ``comment'' to the right of the subject collection. FERC
submissions must be formatted and filed in accordance with submission
guidelines at: https://www.ferc.gov. For user assistance contact FERC
Online Support by email at [email protected], or by phone at
(866) 208-3676 (toll-free).
    Docket: Users interested in receiving automatic notification of
activity in this docket or in viewing/downloading comments and
issuances in this docket may do so at https://www.ferc.gov.

FOR FURTHER INFORMATION CONTACT: Ellen Brown may be reached by email at
[email protected] and telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:
    Title: FERC-521, Payments for Benefits from Headwater Improvements.
    OMB Control No.: 1902-0087.
    Type of Request: Three-year extension of the FERC-521 information
collection requirements with no changes to the reporting requirements.
    Abstract: The purpose of FERC-521 is to implement the information
collection regarding ``headwater benefits'' pursuant to section 10(f)
of the Federal Power Act (FPA).\1\ As defined at 18 CFR 11.10(a)(2),
headwater benefits consist of the additional electric generation of a
downstream project that results from regulation of the flow of a river
by a headwater (i.e., upstream) project, usually by increasing or
decreasing the release of water from a storage reservoir. The
respondents of this information collection are owners of headwater
projects constructed by the United States, by licensees, and pre-1920
permittees. 18 CFR 11.16(b). The Commission requires basic project
information including owner information, location, and storage capacity
to be filed by the respondents.
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    \1\ 16 U.S.C. 803(f).
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    Type of Respondents: There are two types of entities that respond,
Federal and Non-Federal storage and hydropower project owners. The
Federal entities that typically respond include the U.S. Army Corps of
Engineers and the U.S. Department of Interior Bureau of Reclamation.
The Non-Federal entities may consist of any Municipal or Non-Municipal
hydropower project owner.
    Estimate of Annual Burden \2\ and cost \3\: The Commission
estimates the total Public Reporting Burden for this information
collection as:
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    \2\ Burden is defined as the total time, effort, or financial
resources expended by persons to generate, maintain, retain, or
disclose or provide information to or for a Federal agency. For
further explanation of what is included in the information
collection burden, refer to 5 Code of Federal Regulations 1320.3.
    \3\ The estimates for cost per response are derived using the
2022 FERC average salary plus benefits of $188,922/year (or $91.00/
hour). Commission staff finds that the work done for this
information collection is typically done by wage categories similar
to those at FERC.

                                               FERC-521: Payments for Benefits From Headwater Improvements
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                                                        Annual number                                              Total annual burden
                                          Number of     of responses    Total number     Average burden & cost     hours & total annual      Cost per
                                         respondents   per respondent   of responses         per response                  cost           respondent ($)
                                                  (1)             (2)     (1) * (2) =  (4).....................  (3) * (4) = (5)........       (5) / (1)
                                                                                (3)
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Federal and Non-Federal project                     3               1               3  40 hrs.; $3,640.........  120 hrs.; $10,920......          $3,640
 owners.
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    Comments: Comments are invited on: (1) whether the collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden and
cost of the collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information collection; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of automated collection techniques or
other forms of information technology.

    Dated: August 3, 2023.
Debbie-Anne A. Reese,
Deputy Secretary.
[FR Doc. 2023-17063 Filed 8-8-23; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 108 (Wednesday, June 7, 2017)]
[Notices]
[Page 26479]
[FR Doc No: 2017-11756]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Combined Notice of Filings #2

    Take notice that the Commission received the following electric
rate filings:

    Docket Numbers: ER17-1732-000.
    Applicants: Midcontinent Independent System Operator, Inc.
    Description: Sec.  205(d) Rate Filing: 2017-06-01_Asset
Registration Process Clean-up filing to be effective 8/1/2017.
    Filed Date: 6/1/17.
    Accession Number: 20170601-5119.
    Comments Due: 5 p.m. ET 6/22/17.

    Docket Numbers: ER17-1733-000.
    Applicants: Southwest Power Pool, Inc.
    Description: Sec.  205(d) Rate Filing: Attachment AE Revisions
Regarding JOUs Registered Under Combined Resource Option to be
effective 8/1/2017.
    Filed Date: 6/1/17.
    Accession Number: 20170601-5124.
    Comments Due: 5 p.m. ET 6/22/17.

    Docket Numbers: ER17-1735-000.
    Applicants: Pacific Gas and Electric Company.
    Description: Tariff Cancellation: Notice of Termination of Silicon
Valley Power IA (SA 20) to be effective 7/31/2017.
    Filed Date: 6/1/17.
    Accession Number: 20170601-5169.
    Comments Due: 5 p.m. ET 6/22/17.

    Docket Numbers: ER17-1737-000.
    Applicants: PJM Interconnection, L.L.C.
    Description: Tariff Cancellation: Notice of Cancellation of ICSA
No. 3884; Queue No. X4-039 to be effective 5/30/2017.
    Filed Date: 6/1/17.
    Accession Number: 20170601-5205.
    Comments Due: 5 p.m. ET 6/22/17.

    Docket Numbers: ER17-1738-000.
    Applicants: ITC Midwest LLC.
    Description: Sec.  205(d) Rate Filing: Notice of Cancellation of
Dairyland Interconnection and Interchange Agreement to be effective 7/
30/2017.
    Filed Date: 6/1/17.
    Accession Number: 20170601-5221.
    Comments Due: 5 p.m. ET 6/22/17.

    The filings are accessible in the Commission's eLibrary system by
clicking on the links or querying the docket number.
    Any person desiring to intervene or protest in any of the above
proceedings must file in accordance with Rules 211 and 214 of the
Commission's Regulations (18 CFR 385.211 and 385.214) on or before 5:00
p.m. Eastern time on the specified comment date. Protests may be
considered, but intervention is necessary to become a party to the
proceeding.
    eFiling is encouraged. More detailed information relating to filing
requirements, interventions, protests, service, and qualifying
facilities filings can be found at: http://www.ferc.gov/docs-filing/efiling/filing-req.pdf. For other information, call<PHONE_NUMBER>
(toll free). For TTY, call<PHONE_NUMBER>.

    Dated: June 1, 2017.
Kimberly D. Bose,
Secretary.
[FR Doc. 2017-11756 Filed 6-6-17; 8:45 am]
 BILLING CODE 6717-01-P