[Federal Register Volume 84, Number 242 (Tuesday, December 17, 2019)]
[Proposed Rules]
[Pages 68829-68833]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-27045]



[[Page 68829]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 814

[Docket No. FDA-2019-N-3101]


Revised Procedures for the Announcement of Approvals and Denials 
of Premarket Approval Applications and Humanitarian Device Exemption 
Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is 
proposing to amend the medical device regulations regarding the 
procedures for the announcement of approvals and denials of premarket 
approval applications (PMAs) and humanitarian device exemption 
applications (HDEs). We are proposing to discontinue publishing in the 
Federal Register after each quarter a list of PMA and HDE approvals and 
denials announced in that quarter. We will continue to post approval 
and denial notices for PMAs and HDEs on FDA's home page on the internet 
and will also continue to make available on the internet and place on 
public display summaries of safety and effectiveness data (SSED) for 
PMAs and summaries of safety and probable benefit (SSPB) for HDEs. FDA 
is proposing to take this action to improve the efficiency of 
announcing approvals and denials of PMAs and HDEs and to eliminate 
duplication in the current process for announcing this information. We 
are also proposing to update Agency contact information and statutory 
references in certain sections of the PMA and HDE regulations for 
purposes of accuracy, clarity, and consistency.

DATES: Submit either electronic or written comments on the proposed 
rule by March 2, 2020.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. Electronic comments 
must be submitted on or before March 2, 2020. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of March 2, 2020. 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): 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-N-3101 for ``Revised Procedures for the Announcement of 
Approvals and Denials of Premarket Approval Applications and 
Humanitarian Device Exemption Applications.'' 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 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.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.

FOR FURTHER INFORMATION CONTACT: 
    For information concerning the proposed rule as it relates to 
devices regulated by the Center for Biologics Evaluation and Research: 
Jessica Walker Udechukwu, Center for Biologics Evaluation and Research, 
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 
7301, Silver Spring, MD 20993-0002, 240-402-7911.
    For information concerning the proposed rule as it relates to 
devices regulated by the Center for Devices and Radiological Health: 
Joshua Nipper, Center for Devices and Radiological Health, Food and 
Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 1650, 
Silver Spring, MD 20993-0002, 301-796-6524.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Proposed Rule
    B. Summary of the Major Provisions of the Proposed Rule

[[Page 68830]]

    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation
    B. History of the Rulemaking
III. Legal Authority
IV. Description of the Proposed Rule
V. Proposed Effective Date
VI. Preliminary Economic Analysis of Impacts
    A. Introduction
    B. Summary of Benefits and Costs
VII. Paperwork Reduction Act of 1995
VIII. Federalism
IX. Consultation and Coordination With Indian Tribal Governments
X. Reference

I. Executive Summary

A. Purpose of the Proposed Rule

    FDA is proposing to amend its medical device regulations regarding 
the procedures for the announcement of approvals and denials of PMAs 
and HDEs to discontinue the quarterly publication in the Federal 
Register of a list of approvals and denials of both PMAs and HDEs. FDA 
will continue to post approval and denial notices for PMAs and HDEs on 
FDA's home page on the internet (https://www.fda.gov) and will also 
continue to make available on the internet and place on public display 
SSED for PMAs and SSPB for HDEs. FDA is proposing to take this action 
to improve the efficiency of announcing approvals and denials of PMAs 
and HDEs and eliminate duplication in the current process for 
announcing this information. We are also proposing to update Agency 
contact information and statutory references in certain of the PMA and 
HDE regulations for purposes of accuracy, clarity, and consistency.

B. Summary of the Major Provisions of the Proposed Rule

    FDA is proposing to amend its regulations regarding the 
announcement procedures for the approval and denial of PMAs and HDEs. 
FDA is proposing to discontinue publishing in the Federal Register 
after each quarter a list of PMA and HDE approvals and denials 
announced for that quarter. We will continue to post approval and 
denial notices for PMAs and HDEs on FDA's home page on the internet, 
and we will also continue to make SSED for PMAs and SSPB for HDEs 
available on the internet and place them on public display.

C. Legal Authority

    FDA is issuing this proposed rule under sections 515, 520(h), 
520(m), and 701(a) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C. 360e, 360j(h), 360j(m), and 371(a)).

D. Costs and Benefits

    The benefit of this proposed rule, if finalized, is that it would 
result in cost savings to FDA from discontinuing publishing in the 
Federal Register on a quarterly basis, a list of medical device PMA and 
HDE approvals and denials. Annualized over 10 years, the estimated 
benefits (i.e., cost savings) to FDA would range from $0.008 million to 
$0.013 million at both 3 and 7 percent discount rate, with a primary 
estimate of $0.010 million. This proposed rule, if finalized, would 
result in no costs to industry because the rule would not require 
performance of any additional tasks and, therefore, would not impose 
any additional regulatory burden on the industry.

II. Background

A. Need for the Regulation

    FDA is proposing to amend its medical device regulations regarding 
the procedures for the announcement of approvals and denials of PMAs 
and HDEs to discontinue the quarterly publication in the Federal 
Register of a list of approvals and denials of both PMAs and HDEs. FDA 
is proposing to take this action to improve the efficiency of 
announcing approvals and denials of PMAs and HDEs and eliminate 
duplication in announcing this information. The proposed rule, if 
finalized, would allow FDA staff to focus on other Agency priorities 
and utilize FDA staff resources more efficiently. FDA is also proposing 
to revise Sec.  814.44(d)(2) (21 CFR 814.44(d)(2)) to be consistent 
with Sec.  814.45(d)(2) (21 CFR 814.45(d)(2)), which states that 
requests for copies of the current PMA approvals and denials document 
and copies of SSED must be sent in writing to FDA's Freedom of 
Information Staff. In addition, FDA is proposing to update outdated 
references to section 515(d)(3) of the FD&C Act in the PMA (Sec. Sec.  
814.40 (21 CFR 814.40), 814.44, and 814.45) and HDE (Sec.  814.118 (21 
CFR 814.118)) regulations.

B. History of the Rulemaking

    Section 515(d)(4) of the FD&C Act permits an interested person to 
obtain review of an order approving a PMA in accordance with section 
515(g) of the FD&C Act. The statute does not require the Agency to 
publish the approval of a PMA in the Federal Register; however, FDA 
issued in the Federal Register of July 22, 1986 (51 FR 26342) a final 
rule that provided, among other things, that notice of approval of a 
PMA, notice of an order denying approval of a PMA, and notice of an 
order withdrawing approval of a PMA will be published in the Federal 
Register. In the Federal Register of June 26, 1996 (61 FR 33232), FDA 
issued a final rule prescribing, among other things, the procedures for 
submitting HDEs, HDE amendments, and HDE supplements, and the criteria 
for FDA review and approval of HDEs. Furthermore, the final rule of 
June 26, 1996, provided that the notice of approval of an HDE be 
published in the Federal Register in accordance with the rules and 
policies applicable to PMAs submitted under 21 CFR 814.20. That final 
rule also provided that, if FDA issues an order denying approval of an 
HDE, FDA will comply with the same notice and disclosure provisions 
required for PMAs under Sec.  814.45(b) and (d), as applicable.
    In the Federal Register of January 30, 1998 (63 FR 4571), FDA 
issued a final rule discontinuing the publication of individual PMA 
approvals and denials in the Federal Register. The final rule provided 
that FDA would notify the public of PMA approvals and denials by 
posting them on FDA's home page on the internet, by placing SSED on the 
internet and in FDA's Dockets Management Branch, and by publishing in 
the Federal Register after each quarter a list of the PMA approvals and 
denials announced in that quarter. FDA stated that it believed that 
this procedure would expedite public notification of these actions 
because announcements could be placed on the internet more quickly than 
they could be published in the Federal Register, and FDA believed that 
the internet would be accessible to more people than the Federal 
Register.

III. Legal Authority

    We are issuing this proposed rule under the authority of sections 
515, 520(h), and 520(m) of the FD&C Act, which set forth requirements 
for device premarket approval, release of detailed summaries of 
information respecting the safety and effectiveness of devices, and 
humanitarian device exemptions, and under section 701(a) of the FD&C 
Act, which provides FDA the authority to issue regulations for the 
efficient enforcement of the FD&C Act.

IV. Description of the Proposed Rule

    We are proposing to amend 21 CFR part 814 to revise the PMA and HDE 
approval and denial announcement procedures.
    FDA would discontinue publishing in the Federal Register after each 
quarter a list of PMA and HDE approvals and denials announced in that 
quarter (see proposed revisions to Sec. Sec.  814.44, 814.45, and 
814.116). FDA will continue to give the public notice of PMA and HDE

[[Page 68831]]

approvals and denials by placing notices of approval and denial on 
FDA's home page on the internet. Notices of PMA and HDE approval will 
continue to include a notice of opportunity for interested persons to 
request review. FDA considers the 30-day period for requesting 
reconsideration of an FDA action under Sec.  10.33(b) (21 CFR 10.33(b)) 
for notices of PMA and HDE approval to begin on the day the notice is 
placed on the internet. Section 10.33(b) provides that FDA may, for 
good cause, extend this 30-day filing period. In addition, we will 
continue to make available on the internet and place on public display 
SSED and SSPB.
    We are also proposing to revise Sec.  814.44(d)(2), regarding 
requests for copies of the current PMA approvals and denials document 
and copies of SSED, to state that such requests must be sent to the 
Freedom of Information Staff, rather than to the Division of Dockets 
Management. We are proposing this revision because these requests are 
currently handled by the Freedom of Information Staff. Revised Sec.  
814.44(d)(2) would be consistent with current Sec.  814.45(d)(2).
    In addition, FDA is proposing to update outdated references to 
section 515(d)(3) of the FD&C Act in the PMA (Sec. Sec.  814.40, 
814.44, and 814.45) and HDE (Sec.  814.118) regulations. FDA is 
proposing to make this update because section 515(d)(3) of the FD&C Act 
was redesignated as section 515(d)(4) by section 202 of the Food and 
Drug Administration Modernization Act of 1997 (Pub. L. 105-115).

V. Proposed Effective Date

    FDA is proposing that any final rule based on this proposed rule 
become effective 30 days after the date of its publication in the 
Federal Register.

VI. Preliminary Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the proposed rule under Executive 
Order 12866, Executive Order 13563, Executive Order 13771, the 
Regulatory Flexibility Act (5 U.S.C. 601-612), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Orders 12866 and 
13563 direct us to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). Executive Order 13771 
requires that the costs associated with significant new regulations 
``shall, to the extent permitted by law, be offset by the elimination 
of existing costs associated with at least two prior regulations.'' We 
believe that this proposed rule is not a significant regulatory action 
as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because this proposed rule, if finalized, would not impose 
any additional regulatory burden on the industry, we propose to certify 
that the proposed rule will not have a significant economic impact on a 
substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $154 million, using the most current (2018) Implicit 
Price Deflator for the Gross Domestic Product. This proposed rule would 
not result in an expenditure in any year that meets or exceeds this 
amount.

B. Summary of Benefits and Costs

    The benefit of this proposed rule, if finalized, is that it would 
result in cost savings to FDA from discontinuing publishing in the 
Federal Register, on a quarterly basis, a list of medical device PMA 
and HDE approvals and denials. Discontinuing publishing Federal 
Register notices with these approval and denial lists would eliminate 
duplication in announcing this information; information on these 
approvals and denials would continue being readily available to the 
public on FDA's home page on the internet (https://www.fda.gov). We 
estimate no additional benefits beyond these cost savings to FDA.
    We estimate that this proposed rule, if finalized, would result in 
no additional costs to industry because the rule would not require 
performance of any additional tasks. This proposed rule, therefore, 
would not impose any additional regulatory burden on the industry.
    Table 1 summarizes the estimated benefits and costs of the proposed 
rule, if finalized. Annualized over 10 years, the estimated benefits 
(i.e., cost savings) of the proposed rule, if finalized, would range 
from $0.008 million to $0.013 million at both 3 and 7 percent discount 
rate, with a primary estimate of $0.010 million. The present value of 
the estimated benefits (i.e., cost savings) of the proposed rule, if 
finalized, would range from $0.068 million to $0.111 million at a 3 
percent discount rate and from $0.056 million to $0.091 million at a 7 
percent discount rate. The annualized costs of the proposed rule, if 
finalized, would be $0 at both 3 and 7 percent discount rate. The 
present value of costs of the proposed rule, if finalized, would also 
be $0 at both 3 and 7 percent discount rate.

                                    Table 1--Summary of Benefits, Costs, and Distributional Effects of Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                           Units
                                                                           ------------------------------------
               Category                   Primary       Low        High                               Period                      Notes
                                         estimate    estimate    estimate      Year      Discount     covered
                                                                              dollars    rate  (%)    (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
    Annualized Monetized $millions/         $0.010      $0.008      $0.013        2018           7          10  Benefits are cost savings.
     year.
                                             0.010       0.008       0.013        2018           3          10  Benefits are cost savings.
                                       ------------------------------------------------------------------------
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
    Annualized Monetized $millions/              0           0           0        2018           7          10
     year.
                                                 0           0           0        2018           3          10
                                       ------------------------------------------------------------------------

[[Page 68832]]

 
    Annualized Quantified.............  ..........  ..........  ..........  ..........  ..........  ..........
                                       ------------------------------------------------------------------------
    Qualitative.......................  ..........  ..........  ..........  ..........  ..........  ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized        ..........  ..........  ..........  ..........  ..........  ..........
     $millions/year.
                                       ------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
                                       ------------------------------------------------------------------------
    Other Annualized Monetized          ..........  ..........  ..........  ..........  ..........  ..........
     $millions/year.
                                       ------------------------------------------------------------------------
    From/To...........................  From:
                                        To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
    State, Local or Tribal Government: No significant effect............................................................................................
    Small Business: No significant effect...............................................................................................................
    Wages: N/A..........................................................................................................................................
    Growth: N/A.........................................................................................................................................
--------------------------------------------------------------------------------------------------------------------------------------------------------

    In line with Executive Order 13771, in table 2 we discuss 
annualized and present values of costs and cost savings over an 
infinite time horizon. The present value of the net costs would be $0 
at both 3 and 7 percent discount rate. The total annualized cost 
savings would range from $0.008 million to $0.013 million at both 3 and 
7 percent discount rates.

                                                      Table 2--Executive Order 13771 Summary Table
                                               [in $ Millions 2016 Dollars, Over an Infinite Time Horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              Primary          Lower           Upper          Primary          Lower           Upper
                          Item                            estimate  (7%)  estimate  (7%)  estimate  (7%)  estimate  (3%)  estimate  (3%)  estimate  (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs..................................              $0              $0              $0              $0              $0              $0
Present Value of Cost Savings...........................           0.143           0.114           0.186           0.333           0.267           0.433
Present Value of Net Costs..............................         (0.143)         (0.114)         (0.186)         (0.333)         (0.267)         (0.433)
Annualized Costs........................................               0               0               0               0               0               0
Annualized Cost Savings.................................           0.010           0.008           0.013           0.010           0.008           0.013
Annualized Net Costs....................................         (0.010)         (0.008)         (0.013)         (0.010)         (0.008)         (0.013)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Note: Net costs are calculated as costs minus cost savings. Values in parentheses denote net negative costs (i.e. cost-savings).

    We have developed a comprehensive Preliminary Economic Analysis of 
Impacts that assesses the impacts of the proposed rule. The full 
preliminary analysis of economic impacts is available in the docket for 
this proposed rule (Ref. 1) and at https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

VII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this proposed rule contains no 
collection of information. Therefore, clearance by the Office of 
Management and Budget under the Paperwork Reduction Act of 1995 is not 
required.

VIII. Federalism

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. We have determined that 
this proposed rule does not contain policies that have substantial 
direct effects on the States, on the relationship between the National 
Government and the States, or on the distribution of power and 
responsibilities among the various levels of government. Accordingly, 
we conclude that the proposed rule does not contain policies that have 
federalism implications as defined in the Executive Order and, 
consequently, a federalism summary impact statement is not required.

IX. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13175. We have tentatively 
determined that the rule does not contain policies that would have a 
substantial direct effect on one or more Indian Tribes, on the 
relationship between the Federal Government and Indian Tribes, or on 
the distribution of power and responsibilities between the Federal 
Government and Indian Tribes. The Agency solicits comments from tribal 
officials on any potential impact on Indian Tribes from this proposed 
action.

X. Reference

    The following reference is on display at the Dockets Management 
Staff (see ADDRESSES) and is available for viewing by interested 
persons between 9 a.m. and 4 p.m., Monday through Friday; it is also 
available electronically at https://www.regulations.gov. FDA has 
verified the website address, as of the date this document publishes in 
the Federal Register, but websites are subject to change over time.


[[Page 68833]]


1. FDA/Economics Staff, ``Revised Procedures for the Announcement of 
Approvals and Denials of Premarket Approval Applications and 
Humanitarian Device Exemption Applications, Preliminary Regulatory 
Impact Analysis, Preliminary Regulatory Flexibility Analysis, 
Unfunded Mandates Reform Act Analysis,'' 2019 (available at: https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm).

List of Subjects in 21 CFR Part 814

    Administrative practice and procedure, Confidential business 
information, Medical devices, Medical research, Reporting and 
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, it is 
proposed that 21 CFR part 814 be amended as follows:

PART 814--PREMARKET APPROVAL OF MEDICAL DEVICES

0
1. The authority citation for part 814 continues to read as follows:

    Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 360bbb-8b, 
371, 372, 373, 374, 375, 379, 379e, 381.


Sec.  814.40  [Amended]

0
2. In Sec.  814.40, remove ``515(d)(3)'' and add in its place 
``515(d)(4)''


Sec.  814.44  [Amended]

0
3. Amend Sec.  814.44 as follows:
0
a. In the fourth sentence in paragraph (d)(1), remove ``515(d)(3)'' and 
add in its place ``515(d)(4)'' and remove the sixth sentence;
0
b. In paragraph (d)(2), remove ``Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852'' and add in its place ``Freedom of Information 
Staff's address listed on the Agency's website at https://www.fda.gov.''; and
0
c. In paragraphs (e)(2)(ii) and (f)(2), remove ``515(d)(3)'' and add in 
its place ``515(d)(4)''.


Sec.  814.45  [Amended]

0
4. Amend Sec.  814.45 as follows:
0
a. In paragraph (d)(1), remove the third sentence and
0
b. In paragraph (e)(3), remove ``515(d)(3)'' and add in its place 
``515(d)(4)''.
0
5. In Sec.  814.116 revise the fourth sentence in paragraph (b) to read 
as follows:


[thinsp]Sec.  814.116  Procedures for review of an HDE.

    (b) * * * The notice of approval of an HDE will be placed on the 
FDA's home page on the internet (https://www.fda.gov) in accordance 
with the rules and policies applicable to PMAs submitted under Sec.  
814.20. * * *


Sec.  814.118  [Amended]

0
6. In Sec.  814.118(c)(3), remove ``515(d)(3)'' and add in its place 
``515(d)(4)''.

    Dated: December 9, 2019.
Brett P. Giroir,
Acting Commissioner of Food and Drugs.
[FR Doc. 2019-27045 Filed 12-16-19; 8:45 am]
BILLING CODE 4164-01-P