[Federal Register Volume 84, Number 160 (Monday, August 19, 2019)]
[Rules and Regulations]
[Pages 42822-42825]
[FR Doc No: 2019-17746]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R06-OAR-2015-0850; FRL-9998-05-Region 6]

Air Plan Approval; New Mexico; Approval of Revised Statutes;
Error Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: Pursuant to the Federal Clean Air Act (CAA or the Act), the
Environmental Protection Agency (EPA) is approving revisions to New
Mexico's State Implementation Plan (SIP) that incorporate updates to
the New Mexico statutes. EPA is also correcting its previous approval
of some statute provisions as approval of these provisions into the SIP
was in error.

DATES: This final rule is effective on September 18, 2019.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R06-OAR-2015-0850. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, e.g.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through https://www.regulations.gov or
in hard copy at the EPA Region 6 Office, 1201 Elm Street, Suite 500,
Dallas, Texas 75270.

FOR FURTHER INFORMATION CONTACT: Jeff Riley, EPA Region 6 Office,
Infrastructure and Ozone Section, 1201 Elm Street, Suite 500, Dallas,
TX 75270,<PHONE_NUMBER><EMAIL_ADDRESS>To inspect the hard copy
materials, please schedule an appointment with Jeff Riley or Mr. Bill
Deese at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' means the EPA.

I. Background

    The background for this action is discussed in detail in our
February 27, 2019 direct final rule and proposal (84 FR 6334, 84 FR
6353). In the direct final rule, we approved revisions to the New
Mexico SIP that pertain to updated statutes under New Mexico Statutes
Annotated 1978 (NMSA) Chapter 74--Article 2 contained in the State's
August 6, 2015 submittal. We also made an error correction to remove
from the New Mexico SIP certain statutes under NMSA 1978 Chapter 74,
Article 2 originally approved in our November 2, 1984 rulemaking (49 FR
44099).
    The rule and proposal stated that if any relevant adverse comments
were received by the end of the public comment period on March 29,
2019, the direct final rule would be withdrawn, and we would respond to
the comments in a subsequent final action. Relevant adverse comments
were received during the comment period, and the direct final rule was
partially withdrawn on May 16, 2019 (84 FR 22049). This partial
withdrawal only concerned statutes being removed from the SIP (NMSA
sections 74-2-6, 74-2-12 and 74-2-13) through our direct final rule
that were the subject of relevant adverse comments. Our February 27,
2019 proposal provides the basis for this final action.
    We received comments on our proposal from two commenters, the City
of Albuquerque Environmental Health Department (EHD) and the New Mexico
Environmental Department (NMED). Our responses to the comments are
below.

II. Response to Comments

    Comment 1: EHD states that NMSA section 74-2-4 (Local authority)
must be SIP-approved in full to satisfy CAA section 110(a)(2)
requirements because it authorizes creation of a local authority to
assume control over air quality in a local jurisdiction (Albuquerque-
Bernalillo County), using a local board, local agency, and an agency
director to perform duties which would otherwise be performed by the
NMED Secretary in the remainder of the state. This section specifically
grants EHD authority to fulfill CAA responsibilities for Bernalillo
County.
    Response 1: EPA did not address NMSA section 74-2-4 in our February
27, 2019 direct final rulemaking. Thus, this comment is outside the
scope of this rulemaking. However, EPA is addressing this comment in a
separate direct final rulemaking with the opportunity for public
comment published elsewhere in this issue of the Federal Register.

    Comment 2: EHD and NMED state that NMSA section 74-2-5.1 (Duties
and powers of the department and the local agency) must be SIP-approved
to satisfy CAA section 110(a)(2) requirements because it describes the
powers of EHD and NMED to manage air quality and to implement and
enforce air quality requirements, such as the powers to:
     Conduct investigations & studies, entering properties;
     Institute legal proceedings to compel compliance;
     Encourage voluntary cooperation;
     Consult on efficacy of contaminant sources, devices or
controls;
     Establish small business assistance program (CAA section
507);
     Accept & administer grants (CAA section 105); and
     Classify & record air contaminant sources (emission
inventories).
    Further, NMSA section 74-2-5.1 authorizes EHD to develop and
propose control strategies to its Air Board.
    Response 2: EPA did not address NMSA section 74-2-5.1 in our
February 27, 2019 direct final rulemaking. This comment is outside the
scope of this rulemaking. However, EPA is addressing this comment in a
separate direct final rulemaking with the opportunity for public
comment published elsewhere in this issue of the Federal Register.
    Comment 3: EHD and NMED commented that NMSA section 74-2-6
(Adoption of regulations; notice and hearings) should not be removed
from the SIP because it establishes the required legal procedures for
adopting regulations. Both state that if this section is not included
in the SIP, the NMED Environmental Improvement Board and the City of
Albuquerque Air Board do not have the required procedural elements
under the CAA for adopting regulations for a SIP.
    Response 3: EPA's February 27, 2019 action proposed to remove NMSA
section 74-2-6 from the SIP because the language was viewed as
administrative in nature, and therefore need not be made federally
enforceable by incorporating this section into the SIP. The comments
submitted by EHD and NMED have provided clarification that this
language outlines an established process that must occur prior to
adoption and submission of regulations to revise the SIP. We agree with
the commenters that NMSA section 74-2-6 details necessary procedural
elements for adopting regulations that are not provided elsewhere in
SIP-approved regulations and statutes. EPA is approving the August 6,
2015 updates to NMSA section 74-2-6 into the SIP to address this
comment.
    Comment 4: EHD and NMED argue that NMSA section 74-2-12
(Enforcement) should not be removed from the SIP because it confers
general authority to EHD and NMED to manage an effective air quality
enforcement program. Further, both argue that NMSA section 74-2-4(D)
does not convey general enforcement authority to either agency.
    Response 4: EPA's February 27, 2019 action proposed to remove NMSA
section 74-2-12 from the SIP because we viewed the language as being
duplicative of SIP-approved NMSA section 74-2-4(D), which we read to
provide for administration and enforcement of the Air Quality Control
Act. The comments submitted by EHD and NMED have provided clarification
that this language does not confer general enforcement authority to
either agency; rather, NMSA section 74-2-4(D) only authorizes NMED to
assert jurisdiction in Bernalillo County if the Air Board, EHD or the
EHD Director fail to adequately protect air quality. Therefore, we
agree with the commenters that NMSA section 74-2-12 is essential for
demonstrating adequate state legal authority for enforcement actions,
as required by CAA section 110(a)(2)(C). However, we note that this
authority is conferred to each agency by NMSA section 74-2-12(A)(1) &
(2), with the remaining paragraphs providing details specific to each
agency's implementation of the authority granted. The remaining
paragraphs contain elements appropriate for state and local agencies to
adopt and implement, but inclusion of these agency-specific details
into the federally-enforceable SIP is not a requirement under CAA
section 110(a)(2)(C) and may result in confusion regarding applicable
provisions for federal enforcement actions.
    EPA concludes that this authority is not provided elsewhere in SIP-
approved regulations and statutes, and we are approving the August 6,
2015 updates to NMSA section 74-2-12(A)(1) & (2) into the SIP to
address this comment and remove the remainder of NMSA section 74-2-12
from the SIP.
    Comment 5: EHD and NMED assert that NMSA section 74-2-13
(Inspection) should not be removed from the SIP because it authorizes
``right of entry'' on any premises on which an emission source is
located or where required records are stored. It also authorizes the
copying of records, sampling of emissions, and the inspection of
monitoring equipment and methods. Further, both state that this section
provides more specific authority for investigations than the general
authority granted under NMSA section 74-2-5.1.
    Response 5: EPA's February 27, 2019 action proposed to remove NMSA
section 74-2-13 from the SIP because we viewed the language as being
duplicative of NMSA section 74-2-5.1, which we read to confer similar
authority to EHD and NMED to enter any premises the agency has
reasonable cause to believe is or will become a source contributing to
air pollution, as well as authority to require the production of
information relating to emissions that cause or contribute to air
pollution. We note that NMSA section 74-2-5.1 was erroneously cited as
being SIP-approved in our February 27, 2019 action. The comments
submitted by EHD and NMED have provided clarification that NMSA section
74-2-5.1 does grant the authority to make investigations in order to
determine whether a source should be regulated under the AQCA and to
conduct enforcement proceedings to compel compliance, but NMSA section
74-2-13 specifically grants these agencies the right to entry to the
premises on which a regulated emission source is located for the
purposes of reviewing records, inspection of monitoring equipment, or
to conduct sampling. Further, NMSA section 74-2-13 grants these
agencies authority to obtain a search warrant to conduct an inspection
which has been refused. Therefore, we agree with the commenters that
NMSA section 74-2-13 is essential for demonstrating adequate state
legal authority to conduct inspections, as required by CAA section
110(a)(2)(C). EPA concludes that this extent of authority is not
provided elsewhere in SIP-approved regulations and statutes, and we are
approving the August 6, 2015 updates to NMSA section 74-2-13 into the
SIP to address this comment.
    We note that our February 27, 2019 action removed NMSA sections 74-
2-14, 74-2-15, 74-2-15.1, and 74-2-16 from the New Mexico SIP; however,
this removal was not finalized due to inclusion of these sections in a
portion of that rulemaking's amendatory language that also included
NMSA sections 74-2-12 and 74-2-13, which were impacted by the relevant
adverse comments received. EPA's May 16, 2019 partial withdrawal
required our withdrawal of the entire portion of amendatory language.
Our February 27, 2019 removal of NMSA sections 74-2-14, 74-2-15, 74-2-
15.1, and 74-2-16 from the New Mexico SIP did not receive relevant
adverse comments; therefore, EPA is finalizing removal of

these sections through this final rulemaking.

III. Final Action

    We are approving revisions to the New Mexico SIP that pertain to
updated statutes under NMSA 1978 Chapter 74, Article 2 sections 74-2-6,
74-2-12, and 74-2-13 contained in the State's August 6, 2015 submittal.
We are also making an error correction to remove from the New Mexico
SIP certain statutes under NMSA 1978 Chapter 74, Article 2 sections 74-
2-14, 74-2-15, 74-2-15.1, and 74-2-16 originally approved in our
November 2, 1984 rulemaking.

IV. Statutory and Executive Order Reviews

    Under the Clean Air Act, the Administrator is required to approve a
SIP submission that complies with the provisions of the Act and
applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a).
Thus, in reviewing SIP submissions, the EPA's role is to approve state
choices, provided that they meet the criteria of the Clean Air Act.
Accordingly, this action merely approves state law as meeting Federal
requirements and does not impose additional requirements beyond those
imposed by state law. For that reason, this action:
     Is not a ``significant regulatory action'' subject to
review by the Office of Management and Budget under Executive Orders
12866 (58 FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21,
2011);
     Is not an Executive Order 13771 (82 FR 9339, February 2,
2017) regulatory action because SIP approvals are exempted under
Executive Order 12866;
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, described in the Unfunded Mandates
Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of section 12(d) of the
National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272
note) because application of those requirements would be inconsistent
with the CAA; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where EPA or an Indian tribe has
demonstrated that a tribe has jurisdiction. In those areas of Indian
country, the rule does not have tribal implications and will not impose
substantial direct costs on tribal governments or preempt tribal law as
specified by Executive Order 13175 (65 FR 67249, November 9, 2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the Clean Air Act, petitions for
judicial review of this action must be filed in the United States Court
of Appeals for the appropriate circuit by October 18, 2019. Filing a
petition for reconsideration by the Administrator of this final rule
does not affect the finality of this action for the purposes of
judicial review nor does it extend the time within which a petition for
judicial review may be filed, and shall not postpone the effectiveness
of such rule or action. This action may not be challenged later in
proceedings to enforce its requirements. (See section 307(b)(2).)

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Nitrogen dioxide, Ozone, Particulate matter, Reporting and
recordkeeping requirements, Sulfur oxides, Volatile organic compounds.

    Dated: August 13, 2019.
Kenley McQueen,
Regional Administrator, Region 6.

    40 CFR part 52 is amended as follows:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority: 42 U.S.C. 7401 et seq.

Subpart GG--New Mexico

0
2. In Sec.  52.1620(e), the table titled ``EPA-Approved New Mexico
Statutes'' is amended under ``Chapter 74-Environmental Improvement''
by:
0
a. Revising the entries for Sections 74-2-6, 74-2-12, and 74-2-13; and
0
b. Removing the entries for Sections 74-2-14, 74-2-15, 74-2-15.1, and
74-2-16.
    The revisions read as follows:

Sec.  52.1620  Identification of plan.

* * * * *
    (e) * * *

                                        EPA-Approved New Mexico Statutes
----------------------------------------------------------------------------------------------------------------
                                                State approval/
     State citation          Title/subject      effective date     EPA approval date            Comments
----------------------------------------------------------------------------------------------------------------
                                               New Mexico Statutes
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------
                                      Chapter 74--Environmental Improvement
----------------------------------------------------------------------------------------------------------------

                                                  * * * * * * *
74-2-6.................  Adoption of                   8/6/2015  8/19/2019, [Insert
                          regulations; notice                     Federal Register
                          and hearings.                           citation].

                                                  * * * * * * *
74-2-12................  Enforcement;                  8/6/2015  8/19/2019, [Insert    Only paragraphs (A)(1) &
                          compliance orders.                      Federal Register      (2) are SIP-approved
                                                                  citation].            (enforcement authority
                                                                                under CAA section
                                                                                110(a)(2)(C)).
74-2-13................  Inspection..........          8/6/2015  8/19/2019, [Insert
                                                                  Federal Register
                                                                  citation].

                                                  * * * * * * *
----------------------------------------------------------------------------------------------------------------

* * * * *
[FR Doc. 2019-17746 Filed 8-16-19; 8:45 am]
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[Federal Register Volume 87, Number 17 (Wednesday, January 26, 2022)]
[Notices]
[Pages 4036-4037]
[FR Doc No: 2022-01374]

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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 Studies; 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 a final guidance entitled ``Patient Engagement in
the Design and Conduct of Medical Device Clinical Studies.'' The
Patient Engagement Advisory Committee (PEAC) recommended that FDA and
industry develop a framework to clarify how patient advisors can engage
in the clinical investigation process. This guidance focuses on the
applications, perceived barriers, and common challenges of patient
engagement in the design and conduct of medical device clinical
studies.

DATES: The announcement of the guidance is published in the Federal
Register on January 26, 2022.

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-2019-D-3846 for ``Patient Engagement in the Design and Conduct of
Medical Device Clinical Studies.'' 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
``Patient Engagement in the Design and Conduct of Medical Device
Clinical Studies'' 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 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: Michelle Tarver, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5608, Silver Spring, MD 20993-0002, 301-
796-6884 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 studies. The PEAC stated that some framework should be
developed by FDA and industry to clarify how patient advisors can
engage in the clinical study process. Based on this recommendation, FDA
is pursuing various efforts of

encouraging voluntary patient engagement in clinical studies, including
guidance. FDA believes medical device clinical studies designed with
patient input may help to address common challenges faced in medical
device clinical studies.
    While FDA acknowledges that patient engagement may be beneficial
across the total product lifecycle, this guidance focuses on the
applications of patient engagement in the design and conduct of medical
device clinical studies. The guidance will: (1) Help sponsors
understand how they can voluntarily use patient engagement to elicit
experience, perspectives, and other relevant information from patient
advisors (see definition in section IV) to improve the design and
conduct of medical device clinical studies; (2) highlight the benefits
of engaging with patient advisors early in the medical device
development process; (3) illustrate which patient engagement activities
are generally not considered by FDA to constitute research or an
activity subject to FDA's regulations, including regulations regarding
institutional review boards (IRBs); and (4) address common questions
and misconceptions about collecting and submitting to FDA patient
engagement information regarding the design and conduct of a medical
device clinical study.
    A notice of availability of the draft guidance appeared in the
Federal Register of September 24, 2019 (84 FR 50047). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including clarifying terminology, adding additional
background on patient engagement efforts at FDA, and clarifying how
sponsors can obtain specific feedback from FDA on patient engagement
plans and patient-centered study designs.
    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 patient engagement in the design and conduct
of medical device clinical studies. 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 and at https://www.fda.gov/regulatory-information/search-fda-guidance-documents 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
Medical Device Clinical Studies'' may send an email request to [email protected] to receive an electronic copy of the document.
Please use the document number 18040 and complete title to identify the
guidance you are requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no 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 or guidance               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.
``FDA and Industry Procedures for   513(g) Request for         0910-0705
 Section 513(g) Requests for         Information.
 Information under the Federal
 Food, Drug, and Cosmetic Act''.
``Requests for Feedback on Medical  Q-submissions.......       0910-0756
 Device Submissions: The Pre-
 Submission Program and Meetings
 with Food and Drug Administration
 Staff''.
56................................  Institutional Review       0910-0130
                                     Boards.
------------------------------------------------------------------------

    Dated: January 19, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-01374 Filed 1-25-22; 8:45 am]
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