Revised Procedures for the Announcement of Approvals and Denials of Premarket Approval Applications and Humanitarian Device Exemption Applications, 68829-68833 [2019-27045]
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Federal Register / Vol. 84, No. 242 / Tuesday, December 17, 2019 / Proposed Rules
Electronic Submissions
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.
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.
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SUMMARY:
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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
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68829
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-201509-18/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
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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
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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)).
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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 § 814.44(d)(2) (21 CFR
814.44(d)(2)) to be consistent with
§ 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 (§§ 814.40 (21 CFR 814.40),
814.44, and 814.45) and HDE (§ 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
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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 § 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 §§ 814.44, 814.45,
and 814.116). FDA will continue to give
the public notice of PMA and HDE
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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 § 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
§ 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 § 814.44(d)(2)
would be consistent with current
§ 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
(§§ 814.40, 814.44, and 814.45) and HDE
(§ 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
Primary
estimate
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Category
Benefits:
Annualized Monetized $millions/year ..................
Annualized Quantified ..........................................
Qualitative ............................................................
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High
estimate
Year
dollars
Discount
rate
(%)
Period
covered
(years)
$0.010
0.010
$0.008
0.008
$0.013
0.013
2018
2018
7
3
10
10
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
0
0
0
0
0
0
2018
2018
7
3
10
10
Costs:
Annualized Monetized $millions/year ..................
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Low
estimate
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Notes
Benefits are cost savings.
Benefits are cost savings.
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TABLE 1—SUMMARY OF BENEFITS, COSTS, AND DISTRIBUTIONAL EFFECTS OF PROPOSED RULE—Continued
Units
Primary
estimate
Low
estimate
High
estimate
Annualized Quantified ..........................................
..................
..................
Qualitative ............................................................
..................
Transfers:
Federal Annualized Monetized $millions/year .....
..................
Category
From/To ...............................................................
From:
Other Annualized Monetized $millions/year ........
..................
From/To ...............................................................
From:
Year
dollars
Discount
rate
(%)
Period
covered
(years)
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
..................
Notes
To:
..................
..................
..................
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
estimate
(7%)
Item
Present Value of Costs ............................
Present Value of Cost Savings ................
Present Value of Net Costs .....................
Annualized Costs .....................................
Annualized Cost Savings .........................
Annualized Net Costs ..............................
$0
0.143
(0.143)
0
0.010
(0.010)
Lower
estimate
(7%)
Upper
estimate
(7%)
$0
0.114
(0.114)
0
0.008
(0.008)
$0
0.186
(0.186)
0
0.013
(0.013)
Primary
estimate
(3%)
$0
0.333
(0.333)
0
0.010
(0.010)
Lower
estimate
(3%)
$0
0.267
(0.267)
0
0.008
(0.008)
Upper
estimate
(3%)
$0
0.433
(0.433)
0
0.013
(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
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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
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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
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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.
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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
1. The authority citation for part 814
continues to read as follows:
■
§ 814.118
[Amended]
6. In § 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
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG–107431–19]
RIN 1545–BP40
Treatment of Payments to Charitable
Entities in Return for Consideration
Authority: 21 U.S.C. 351, 352, 353, 360,
360c–360j, 360bbb–8b, 371, 372, 373, 374,
375, 379, 379e, 381.
Internal Revenue Service (IRS),
Treasury.
ACTION: Notice of proposed rulemaking
and notification of public hearing.
§ 814.40
SUMMARY:
AGENCY:
[Amended]
2. In § 814.40, remove ‘‘515(d)(3)’’ and
add in its place ‘‘515(d)(4)’’
■
§ 814.44
[Amended]
3. Amend § 814.44 as follows:
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;
■ 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
■ c. In paragraphs (e)(2)(ii) and (f)(2),
remove ‘‘515(d)(3)’’ and add in its place
‘‘515(d)(4)’’.
■
■
§ 814.45
[Amended]
4. Amend § 814.45 as follows:
a. In paragraph (d)(1), remove the
third sentence and
■ b. In paragraph (e)(3), remove
‘‘515(d)(3)’’ and add in its place
‘‘515(d)(4)’’.
■ 5. In § 814.116 revise the fourth
sentence in paragraph (b) to read as
follows:
■
■
jbell on DSKJLSW7X2PROD with PROPOSALS
page on the internet (https://
www.fda.gov) in accordance with the
rules and policies applicable to PMAs
submitted under § 814.20. * * *
§ 814.116
HDE.
Procedures for review of an
(b) * * * The notice of approval of an
HDE will be placed on the FDA’s home
VerDate Sep<11>2014
16:54 Dec 16, 2019
Jkt 250001
This document provides
proposed amendments to the
regulations under sections 162, 164, and
170 of the Internal Revenue Code
(Code). First, the proposed amendments
update the regulations under section
162 to reflect current law regarding the
application of section 162 to a taxpayer
that makes a payment or transfer to an
entity described in section 170(c) for a
business purpose. Second, the proposed
amendments provide safe harbors under
section 162 to provide certainty with
respect to the treatment of payments
made by business entities to an entity
described in section 170(c). Third, the
proposed amendments provide a safe
harbor under section 164 for payments
made to an entity described in section
170(c) by individuals who itemize
deductions and receive or expect to
receive a state or local tax credit in
return. Fourth, the proposed
amendments update the regulations
under section 170 to reflect past
guidance and case law regarding the
application of the quid pro quo
principle under section 170 to benefits
received or expected to be received by
a donor from a third party.
DATES: Written or electronic comments
must be received by January 31, 2020
Requests to speak and outlines of topics
to be discussed at the public hearing
scheduled for February 20, 2020, must
be received by January 31, 2020.
PO 00000
Frm 00019
Fmt 4702
Sfmt 4702
68833
Submit electronic
submissions via the Federal
eRulemaking Portal at https://
www.regulations.gov (indicate IRS and
REG–107431–19) by following the
online instructions for submitting
comments. Once submitted to the
Federal eRulemaking Portal, comments
cannot be edited or withdrawn. The
Department of the Treasury (Treasury
Department) and the IRS will publish
for public availability any comment
received to its public docket, whether
submitted electronically or in hard
copy. Send hard copy submissions to:
CC:PA:LPD:PR (REG–107431–19), Room
5203, Internal Revenue Service, P.O.
Box 7604, Ben Franklin Station,
Washington, DC 20044. Submissions
may be hand-delivered Monday through
Friday between the hours of 8 a.m. and
4 p.m. to CC:PA:LPD:PR (REG–107431–
19), Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue NW,
Washington, DC 20224.
FOR FURTHER INFORMATION CONTACT:
Concerning the proposed regulations,
Mon L. Lam and Merrill D. Feldstein at
(202) 317–4059; concerning submission
of comments and requests to speak at
the public hearing, Regina Johnson at
(202) 317–6901 (not toll-free numbers)
or fdms.database@irscounsel.treas.gov.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Background and Explanation of
Provisions
I. Contributions in Exchange for State
and Local Tax Credits
Section 170(a)(1) generally allows an
itemized deduction for any ‘‘charitable
contribution’’ paid within the taxable
year. Section 170(c) defines ‘‘charitable
contribution’’ as a ‘‘contribution or gift
to or for the use of ’’ an entity described
in that section. Under section 170(c)(1),
such entities include a State, a
possession of the United States, or any
political subdivision of the foregoing, or
the District of Columbia. Section
170(c)(2) includes certain corporations,
trusts, or community chests, funds, or
foundations, organized and operated
exclusively for religious, charitable,
scientific, literary, or educational
purposes, or to foster national or
international amateur sports
competition, or for the prevention of
cruelty to children or animals. Section
1.170A–1(c)(5) of the Income Tax
Regulations provides that transfers of
property to an organization described in
section 170(c) that bear a direct
relationship to the taxpayer’s trade or
business and that are made with a
reasonable expectation of financial
return commensurate with the amount
of the transfer may constitute allowable
E:\FR\FM\17DEP1.SGM
17DEP1
]]>Agencies
[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]]
=======================================================================
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
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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]
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2. In Sec. 814.40, remove ``515(d)(3)'' and add in its place
``515(d)(4)''
Sec. 814.44 [Amended]
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3. Amend Sec. 814.44 as follows:
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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;
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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
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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]
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4. Amend Sec. 814.45 as follows:
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a. In paragraph (d)(1), remove the third sentence and
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b. In paragraph (e)(3), remove ``515(d)(3)'' and add in its place
``515(d)(4)''.
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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]
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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
