[Federal Register Volume 88, Number 211 (Thursday, November 2, 2023)]
[Notices]
[Pages 75291-75292]
[FR Doc No: 2023-24213]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-4595]

Enforcement Policy for Certain Supplements for Approved Premarket
Approval or Humanitarian Device Exemption Submissions; 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 final guidance entitled ``Enforcement Policy
for Certain Supplements for Approved Premarket Approval (PMA) or
Humanitarian Device Exemption (HDE) Submissions.'' This guidance
outlines FDA's policies and regulatory review expectations after the
COVID-19 public health emergency (PHE) for certain limited
modifications affecting the safety and effectiveness of a device
required to have an approved PMA or the safety and probable benefit of
a device required to have an approved HDE. This guidance has been
implemented without prior comment, but it remains subject to comment in
accordance with the Agency's good guidance practices.

DATES: The announcement of the guidance is published in the Federal
Register on November 2, 2023.

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-2023-D-4595 for ``Enforcement Policy for Certain Supplements for
Approved Premarket Approval (PMA) or Humanitarian Device Exemption
(HDE) Submissions.'' 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, 240-
402-7500.
     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
``Enforcement Policy for Certain Supplements for Approved Premarket
Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions'' 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 or to the Office of Communication,
Outreach and Development, Center for Biologics Evaluation and Research
(CBER), 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: Jhumur Banik, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2448, Silver Spring, MD 20993-0002,<PHONE_NUMBER> or
Anne Taylor, 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

    FDA is announcing the availability of a final guidance entitled
``Enforcement Policy for Certain Supplements for Approved Premarket
Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions.''
This guidance describes FDA's general recommendations for limited
modifications to devices required to have an approved PMA or HDE to
help address manufacturing limitations or supply chain disruptions.
This guidance supersedes ``Supplements for Approved Premarket Approval
(PMA) or Humanitarian Device Exemption (HDE) Submissions During the
Coronavirus Disease 2019 (COVID-19) Public Health Emergency
(Revised)'', issued in May 2020 and updated in May 2022 (COVID-19 PMA/
HDE guidance). In the Federal Register of March 13, 2023 (88 FR 15417),
FDA announced that COVID-19 PMA/HDE guidance was being revised to
continue in effect for 180 days after the expiration of the COVID-19
PHE declaration issued under the Public Health Service Act, during
which time FDA intended to further revise the guidance.
    Following expiration of the PHE declaration on May 11, 2023, FDA
has continued to observe supply chain challenges and shortages of
medical devices remain widespread. Therefore, consistent with the
Federal Register of March 13, 2023, FDA is issuing this final guidance.
Although this guidance has been revised to remove any expiration date
for the enforcement policy, the Agency will continue to monitor the
situation and may make further revisions to the guidance, withdraw the
guidance, or pursue other regulatory actions, as appropriate.
    FDA has determined that this guidance document presents a less
burdensome policy that is consistent with public health. This guidance
is being implemented without prior public comment because FDA has
determined that prior public participation for this less burdensome
policy is neither feasible nor appropriate (see section 701(h)(1)(C) of
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C.
371(h)(1)(C)) and 21 CFR 10.115(g)(2)) because delaying this policy is
likely to exacerbate ongoing supply chain issues. This guidance
document is being implemented immediately, but it remains subject to
comment in accordance with the Agency's good guidance practices.
    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 ``Enforcement Policy for Certain Supplements
for Approved Premarket Approval (PMA) or Humanitarian Device Exemption
(HDE) Submissions.'' 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, https://www.fda.gov/regulatory-information/search-fda-guidance-documents or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Enforcement Policy for Certain Supplements for Approved Premarket
Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions'' may
send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number
GUI00020028 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. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in the following table have been approved by OMB:

------------------------------------------------------------------------
                                                           OMB  control
21 CFR part; guidance; or FDA form          Topic               No.
------------------------------------------------------------------------
814, subparts A through E.........  Premarket approval..       0910-0231
814, subpart H....................  Humanitarian Use           0910-0332
                                     Devices;
                                     Humanitarian Device
                                     Exemption.
800, 801, and 809.................  Medical Device             0910-0485
                                     Labeling
                                     Requirements;
                                     Unique Device
                                     Identification.
820...............................  Current Good               0910-0073
                                     Manufacturing
                                     Practice; Quality
                                     Systems.
807, subparts A through D.........  Medical Device             0910-0625
                                     Registration and
                                     Listing.
``Fostering Medical Device          Medical Devices--          0910-0922
 Improvement: FDA Activities and     Voluntary
 Engagement with the Voluntary       Improvement Program.
 Improvement Program''.
------------------------------------------------------------------------

    Dated: October 30, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-24213 Filed 11-1-23; 8:45 am]
BILLING CODE 4164-01-P


February 24, 2012

MEMORANDUM

TO: 			Air Docket EPA-HQ-OAR-2011-0542

SUBJECT:	Presentation to the International Conference on Oil Palm and
Environment (ICOPE)

On February 23, 2012, EPA briefed the ICOPE in Bali, Indonesia on the
Agency’s Notice of Data Availability for Renewable Fuels Produced from
Palm Oil Under the Renewable Fuel Standard Program.  EPA participated
via teleconference from Washington, DC.

Attendees at ICOPE included roughly 500 stakeholders with an interest in
oil palm and the environment.  More information about ICOPE is available
at   HYPERLINK "http://www.icope-series.com/conferences_detail"
http://www.icope-series.com/conferences_detail .

EPA’s presentation was delivered by Sharyn Lie, the Director of the
Climate and Economic Modeling Center (CEMC), Transportation and Climate
Division, Office of Transportation and Air Quality.  Aaron Levy, a
program analyst in CEMC, was also on the line from Washington.

The slides used for EPA’s presentation are attached with this docket
entry.

  PAGE   \* MERGEFORMAT  1


[Federal Register: December 29, 2006 (Volume 71, Number 250)]
[Notices]
[Page 78421]
[DOCID:fr29de06-60]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. RM06-10-000]

New PURPA Section 210(m) Regulations Applicable to Small Power
Production and Cogeneration Facilities; Notice of New Docket Prefix
``QM''

December 21, 2006.
    On October 20, 2006, the Commission issued Order No. 688\1\ which
would modify the mandatory power purchase obligation for electric
utilities under the Public Utility Regulatory Policies Act of 1978
(PURPA). Order No. 688 implements a mandate of the Energy Policy Act of
2005. The final rule, ``New PURPA Section 210(m) Regulations,
Applicable to Small Power Production and Cogeneration Facilities,''
takes effect 60 days after publication in the Federal Register or
January 2, 2007.
    Notice is hereby given that a new docket prefix ``QM'' has been
established for certain applications under Order No. 688. A new ``QM''
docket number will be assigned to applications filed under the
following sections of the Commission's regulations:

1. 18 CFR 292.310: Application by an electric utility for a Commission
determination that they may be relieved of the PURPA obligation to
purchase power from qualifying facilities on a service territory-wide
basis;
2. 18 CFR 292.311: Application by a qualifying facility, State agency,
or other affected person for a Commission order reinstating the
utility's obligation to purchase;
3. 18 CFR 292.312: Application by an electric utility for relief from
the obligation to sell power on a service territory-wide basis, or a
single qualifying facility basis; and
4. 18 CFR 292.313: Application by a qualifying facility, a State
agency, or other affected person for a Commission order reinstating the
electric utility's obligation to sell.

    Filing guidelines for ``QM'' filings are attached to this notice
and will be posted on the Commission's Web site at http://www.ferc.gov/help/how-to.asp.
 The Commission encourages electronic filing of all QM

applications, provided the content is entirely in the public domain. If
the application contains Privileged or Critical Energy Infrastructure
Information, you must file on paper.

Magalie R. Salas,
Secretary.
---------------------------------------------------------------------------

    \1\ New PURPA Section 210(m) Regulations Applicable to Small
Power Production and Cogeneration Facilities, FERC Statutes and
Regulations [par] 31,233 (2006) (Order No. 688), 71 FR 64,342
(2006).
---------------------------------------------------------------------------

 [FR Doc. E6-22364 Filed 12-28-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 83, Number 224 (Tuesday, November 20, 2018)]
[Rules and Regulations]
[Page 58506]
[FR Doc No: C1-2018-24747]

=======================================================================
-----------------------------------------------------------------------

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 51, 60, and 63

[EPA-HQ-OAR-2016-0510; FRL-9986-42-OAR]
RIN 2060-AS95

Revisions to Testing Regulations for Air Emission Sources

Correction

    In rule document 2018-24747, appearing on pages 56713 through 56734
in the issue of Wednesday, November 14, 2018 make the following
correction:

0
On page 56732, the asterisks directly above Eq. 323-8 were printed in
error and those after were omitted. The equation is corrected to appear
as set forth below:

Appendix A to Part 63 [Corrected]

Method 323-Measurment of Formaldehyde Emissions From Natural Gas-Fired
Stationary Sources-Acetyl Acetone Derivitization Method

* * * * *
[GRAPHIC] [TIFF OMITTED] TR20NO18.013

* * * * *
[FR Doc. C1-2018-24747 Filed 11-19-18; 8:45 am]
BILLING CODE 1301-00-D