Revocation of the Regulations for Human Tissue Intended for Transplantation and Human Dura Mater, 82990-82994 [2020-27828]
Download as PDF
<![CDATA[
82990
Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules
2-P methyl glycidate (PMK glycidate),
3,4-MDP-2-P methyl glycidic acid (PMK
glycidic acid), and alpha-
phenylacetoacetamide (APAA) in the
table ‘‘Table of Concentration Limits’’ to
read as follows:
§ 1310.12
*
Exempt chemical mixtures.
*
*
(c) * * *
*
*
TABLE OF CONCENTRATION LIMITS
DEA
chemical
code No.
*
*
*
3,4-MDP-2-P methyl glycidate (PMK glycidate) and
its optical and geometric isomers.
3,4-MDP-2-P methyl glycidic acid (PMK glycidic
acid) and its salts, optical and geometric isomers, and salts of isomers.
alpha-phenylacetoacetamide (APAA) and its optical isomers.
*
*
*
*
*
*
BILLING CODE 4410–09–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 882 and 1270
[Docket No. FDA–2020–N–1519]
RIN 0910–AI41
Revocation of the Regulations for
Human Tissue Intended for
Transplantation and Human Dura
Mater
Food and Drug Administration,
HHS.
Proposed rule.
The Food and Drug
Administration (FDA, the Agency, or
we) is proposing to revoke the
regulations for human tissue intended
for transplantation and human dura
mater recovered prior to May 25, 2005.
The proposed revocation does not affect
the regulations for human cells, tissues,
and cellular and tissue-based products
(HCT/Ps) recovered on or after May 25,
2005. FDA is proposing this action
because these regulations are obsolete or
no longer necessary to achieve public
health goals. This action is part of FDA’s
implementation of Executive Orders
13771 and 13777. Under these
Executive Orders, FDA is
comprehensively reviewing existing
regulations to identify opportunities for
repeal, replacement, or modification
that will result in meaningful burden
SUMMARY:
VerDate Sep<11>2014
23:57 Dec 18, 2020
8515
Jkt 253001
*
Not exempt at any concentration.
Not exempt at any concentration.
Special conditions
*
Chemical mixtures
chemical are not
Chemical mixtures
chemical are not
Not exempt at any concentration.
*
*
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.
PO 00000
Frm 00041
Fmt 4702
Sfmt 4702
*
*
containing any amount of this
exempt.
containing any amount of this
exempt.
Chemical mixtures containing any amount of this
chemical are not exempt.
reduction, while allowing the Agency to
achieve our public health mission and
fulfill statutory obligations.
DATES: Submit either electronic or
written comments on the proposed rule
by March 8, 2021.
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 8,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of March 8, 2021. 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.
*
[FR Doc. 2020–26813 Filed 12–18–20; 8:45 am]
ACTION:
8525
*
Timothy J. Shea,
Acting Administrator.
AGENCY:
8535
Concentration
*
*
• 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–
2020–N–1519 for ‘‘Revocation of the
Regulations for Human Tissue Intended
for Transplantation.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ will be publicly viewable
at https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
E:\FR\FM\21DEP1.SGM
21DEP1
Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on
https://www.regulations.gov. Submit
both copies to the Dockets Management
Staff. If you do not wish your name and
contact information to be made publicly
available, you can provide this
information on the cover sheet and not
in the body of your comments and you
must identify this information as
‘‘confidential.’’ Any information marked
as ‘‘confidential’’ will not be disclosed
except in accordance with 21 CFR 10.20
and other applicable disclosure law. For
more information about FDA’s posting
of comments to public dockets, see 80
FR 56469, September 18, 2015, or access
the information at: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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, 240–402–7500.
FOR FURTHER INFORMATION CONTACT:
Shruti Modi, 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.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the
Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Background
A. Introduction
B. Need for Regulation/History of
Regulation
C. Applicability of § 882.5975 and Part
1270
III. Legal Authority
IV. Description of the Proposed Rule
V. Proposed Effective Date
VI. Preliminary Economic Analysis of
Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With
Indian Tribal Governments
XI. References
VerDate Sep<11>2014
21:22 Dec 18, 2020
Jkt 253001
I. Executive Summary
A. Purpose of the Proposed Rule
FDA proposes to remove the
regulations under part 1270 (21 CFR
part 1270), ‘‘Human Tissue Intended for
Transplantation’’ and § 882.5975 (21
CFR 882.5975), ‘‘Human dura mater.’’
These regulations apply to certain
tissues recovered prior to May 25, 2005.
The Agency does not believe there are
currently any tissues intended for
transplantation remaining in inventory
that were recovered prior to this date
and that would be subject to these
regulations. Therefore, the regulations
under this part are outdated and
obsolete. All HCT/Ps recovered on or
after May 25, 2005, are subject to the
regulations under part 1271 (21 CFR
part 1271), ‘‘Human Cells, Tissues, and
Cellular and Tissue-Based Products.’’
B. Summary of the Major Provisions of
the Proposed Rule
The proposed rule would remove part
1270 ‘‘Human Tissue Intended for
Transplantation,’’ which applies to
certain human tissue and to
establishments or persons engaged in
the recovery, screening, testing,
processing, storage, or distribution of
human tissue. It would also remove
§ 882.5975, ‘‘Human dura mater,’’ which
identifies and classifies Human dura
mater recovered prior to May 25, 2005.
C. Legal Authority
FDA is taking this action under the
communicable disease provisions of the
Public Health Service Act (the PHS Act)
and the device provisions of the Federal
Food, Drug, and Cosmetic Act (the
FD&C Act).
D. Costs and Benefits
Because this proposed rule would not
impose any additional burden on the
industry, this regulation is not
anticipated to result in any compliance
costs. The costs and cost savings to FDA
resulting from removing an obsolete
regulation are expected to be minimal.
II. Background
A. Introduction
On February 24, 2017, Executive
Order 13777, entitled ‘‘Enforcing the
Regulatory Reform Agenda’’ (https://
www.federalregister.gov/documents/
2017/03/01/2017-04107/enforcing-theregulatory-reform-agenda, 82 FR 12285,
March 1, 2017) was issued. One of the
provisions of the Executive Order
requires Agencies to evaluate existing
regulations and make recommendations
to the Agency head regarding their
repeal, replacement, or modification,
consistent with applicable law. As part
PO 00000
Frm 00042
Fmt 4702
Sfmt 4702
82991
of this initiative, FDA is proposing to
revoke certain regulations as specified
in this proposed rule.
B. Need for Regulation/History of
Rulemaking
FDA regulates articles containing or
consisting of human cells or tissues
intended for implantation,
transplantation, infusion, or transfer
into a human recipient. These are
defined in § 1271.3(d) as HCT/Ps.
Tissues as defined in § 1270.3(j)
recovered prior to May 25, 2005, are
regulated under part 1270. HCT/Ps
recovered on or after May 25, 2005, are
subject to the regulations in part 1271.
Examples of HCT/Ps include, but are
not limited to the following: bone,
ligament, skin, cornea, ligament, dura
mater, heart valve, hematopoietic stem/
progenitor cells derived from peripheral
and cord blood, and semen or other
reproductive tissue. Vascularized
human organs for transplantation are
not considered HCT/Ps. FDA currently
regulates human dura mater recovered
prior to May 25, 2005, under § 882.5975.
In the Federal Register of December
14, 1993 (58 FR 65514), FDA published
an interim rule (1993 interim rule) for
Human Tissue Intended for
Transplantation. This rule provided
specific donor suitability and testing
requirements for certain tissue products.
As the use of human tissue for
transplantation increased, FDA
determined that there was a need for a
much more comprehensive set of
regulatory requirements that included a
broader scope of products. In the
Federal Register of July 29, 1997 (62 FR
40429), FDA issued a final rule which
clarified and modified provisions of the
1993 interim rule.
In the Federal Register of March 4,
1997 (62 FR 9721), FDA announced the
availability of a document entitled
‘‘Proposed Approach to the Regulation
of Cellular and Tissue-Based Products.’’
The purpose was to develop a plan to
address the regulation of human cellular
and tissue-based products in a more
comprehensive, but not unduly
burdensome manner. The plan detailed
how cellular and tissue-based products
would be regulated with a tiered
approach based on risk and the
necessity for FDA review.
As part of this approach, FDA
advanced three regulatory proposals
including: (1) Registration and Listing;
(2) Communicable-Disease Screening
and Testing; and (3) Processing
Standards. FDA published three final
rules to implement the proposed
approach as follows:
(1) ‘‘Human Cells, Tissues, and
Cellular and Tissue-Based Products;
E:\FR\FM\21DEP1.SGM
21DEP1
82992
Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules
Establishment Registration and Listing’’
(66 FR 5447, January 19, 2001), which
set forth part 1271, subpart A (General
Provisions) and subpart B (Procedures
for Registration and Listing) (effective
dates April 4, 2001, and January 21,
2004 based on the applicability of the
HCT/P establishment). The final rule
requires HCT/P establishments to
register with the Agency and list the
HCT/Ps they manufacture.
(2) ‘‘Eligibility Determination for
Donors of Human Cells, Tissues, and
Cellular and Tissue-Based Products’’ (69
FR 29786, May 25, 2004), which set
forth part 1271, subpart C (Donor
Eligibility) (effective date May 25, 2005).
The final rule requires HCT/P
establishments to screen and test cell
and tissue donors for risk factors for,
and clinical evidence of, relevant
communicable disease agents and
diseases.
(3) ‘‘Current Good Tissue Practice for
Human Cell, Tissue, and Cellular and
Tissue-Based Product Establishments,
Inspection and Enforcement’’ (69 FR
68611, November 24, 2004), which set
forth part 1271, subpart D (Current Good
Tissue Practice), subpart E (Additional
Requirements for Establishments
Described in § 1271.10), and subpart F
(Inspection and Enforcement of
Establishments Described in § 1271.10)
(effective date May 25, 2005). The final
rule requires HCT/P establishments to
follow current good tissue practice,
which governs the methods used in, and
the facilities and controls used for, the
manufacture of HCT/Ps; recordkeeping;
and the establishment of a quality
program.
FDA issued these regulations to
increase the safety of HCT/Ps, and
public confidence in their safety, by
helping to prevent the introduction,
transmission, and spread of
communicable disease. The regulations
were issued to protect the public health
while minimizing regulatory burden,
which in turn would encourage
significant innovation.
C. Applicability of § 882.5975 and Part
1270
The Agency did not revoke part 1270
at the same time the Agency proposed
part 1271 because it would have been
impractical to apply part 1271
retroactively to human tissue, as defined
in § 1270.3(j), that was recovered before
the effective date of the final rule.
Instead, the Agency decided that human
tissue, as defined in § 1270.3(j), that was
recovered prior to May 25, 2005, would
remain subject to the regulations in part
1270. However, in the final rules
applicable to HCT/Ps (66 FR 5447 and
5448; 69 FR 68611), FDA noted its
VerDate Sep<11>2014
21:22 Dec 18, 2020
Jkt 253001
intention to revoke part 1270 in the
future when we were confident that
there was no human tissue regulated
under part 1270 available for use.
Part 1270 applies only to human
tissue defined in § 1270.3(j) and
recovered prior to May 25, 2005. The
device classification set forth in 21 CFR
882.5975, ‘‘Human dura mater,’’ is only
applicable to human dura mater
recovered prior to May 25, 2005. Human
dura mater recovered on or after May
25, 2005, is subject to the regulations in
part 1271 when an establishment does
not qualify for any of the exceptions in
§ 1271.15. Further, human dura mater is
regulated solely under section 361 of the
PHS Act and part 1271 when the HCT/
P meets all the criteria set out in
§ 1271.10(a). Otherwise the HCT/P is
regulated as a drug, device, and/or
biological product under the FD&C Act,
and/or section 351 of the PHS Act, and
applicable regulations, including part
1271.
Products that meet the definition of
an HCT/P in § 1271.3(d) that are
recovered on or after May 25, 2005,
including those that have been regulated
after May 25, 2005, as drugs, devices,
and/or biological products under
section 351 of the PHS Act and/or the
FD&C Act will not be affected by
revocation of part 1270.
We do not believe there are currently
any tissues intended for transplantation
remaining in inventory that were
recovered prior to May 25, 2005, that
would be subject to these regulations.
Therefore, the regulations under
§ 882.5975 and part 1270 are outdated
and obsolete.
III. Legal Authority
FDA is issuing this proposed rule
under the communicable disease
provisions of the PHS Act, which
provide FDA with the authority to issue
and enforce regulations designed to
prevent the introduction, transmission,
and spread of communicable disease (42
U.S.C. 216, 243, 264, 271), and
provisions of the FD&C Act applicable
to devices (21 U.S.C. 351, 360, 360c,
360e, 360j, 360l, 371)).
IV. Description of the Proposed Rule
Part 1270 became effective in 1997,
and applies only to human tissue
defined in § 1270.3(j) and recovered
prior to May 25, 2005. It is highly
unlikely there is any human tissue
regulated under part 1270 remaining in
inventory today that is suitable for
human transplantation. This regulation
is outdated and has been replaced with
part 1271.
PO 00000
Frm 00043
Fmt 4702
Sfmt 4702
V. Proposed Effective Date
FDA is proposing that any final rule
based on the proposed rule become
effective 30 days after the date of its
publication in the Federal Register.
VI. Preliminary Economic Analysis of
Impacts
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 the proposed rule, if finalized,
would not create new regulatory
responsibilities for small entities, 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 $156 million,
using the most current (2019) 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.
This proposed rule, if finalized,
would remove the obsolete regulations
under part 1270 for human tissue
intended for transplantation into a
human recipient and § 882.5975 for
human dura matter. These regulations
E:\FR\FM\21DEP1.SGM
21DEP1
82993
Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules
only apply to tissue derived from a
human body and recovered prior to May
25, 2005. We believe it is highly
unlikely any such human tissues remain
available for use today. The proposed
rule therefore is not anticipated to result
in any compliance costs to the industry.
We expect the economic impact on the
FDA resulting from removing an
obsolete regulation to be minimal.
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 would be $0 at both
the 3 and 7 percent discount rate. The
present value of the estimated benefits
(i.e., cost savings) of the proposed rule
would also be $0 at both the 3 and 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 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
Category
Benefits:
Annualized Monetized $millions/year ............................................
Low
estimate
$0
0
High
estimate
$0
0
Year
ollars
Period
covered
(years)
Discount
rate
$0
0
2019
2019
7
3
10
10
10
10
Notes
Annualized Quantified ...................................................................
Qualitative ......................................................................................
Costs:
Annualized Monetized millions/year ..............................................
Annualized Quantified ...................................................................
Field investigators would no longer
need to reference the obsolete
regulations, resulting in very minor
cost savings for FDA in terms of
employee time.
0
0
..................
0
0
..................
0
0
..................
2019
2019
..................
7
3
7
3
..................
..................
..................
..................
7
3
Qualitative ......................................................................................
Transfers:
Federal Annualized Monetized millions/year ................................
From/To .........................................................................................
From:
Other Annualized Monetized millions/year ....................................
..................
From/To .........................................................................................
From:
To:
..................
..................
..................
7
3
To:
Effects:
State, Local or Tribal Government: None.
Small Business: None.
Wages: None.
Growth: None.
In line with Executive Order 13771, in
table 2 we estimate present and
annualized values of costs and cost
savings over an infinite time horizon.
The present value of the net costs and
cost savings would be $0 at both 3 and
7 percent discount rate.
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
0
0
0
0
We have developed a comprehensive
Preliminary Economic Analysis of
Impacts that assesses the impacts of the
VerDate Sep<11>2014
21:22 Dec 18, 2020
Jkt 253001
Lower
estimate
(7%)
Upper
estimate
(7%)
$0
0
0
0
0
0
Primary
estimate
(3%)
$0
0
0
0
0
0
proposed rule. The full preliminary
analysis of economic impacts is
available in the docket for this proposed
PO 00000
Frm 00044
Fmt 4702
Sfmt 4702
Lower
estimate
(3%)
$0
0
0
0
0
0
Upper
estimate
(3%)
$0
0
0
0
0
0
$0
0
0
0
0
0
rule (Ref. 1) and https://www.fda.gov/
AboutFDA/ReportsManualsForms/
Reports/EconomicAnalyses/default.htm.
E:\FR\FM\21DEP1.SGM
21DEP1
82994
Federal Register / Vol. 85, No. 245 / Monday, December 21, 2020 / Proposed Rules
VII. Analysis of Environmental Impact
We have determined under 21 CFR
25.31(h) that this action is of a type that
does not individually or cumulatively
have a significant effect on the human
environment. Therefore, neither an
environmental assessment nor an
environmental impact statement is
required.
VIII. 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 Paper Reduction Act of 1995 is not
required.
IX. Federalism
We have analyzed this proposed rule
in accordance with the principles set
forth in Executive Order 13132. We
have determined that the 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 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.
X. 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.
XI. References
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.
1. FDA, ‘‘Preliminary Regulatory Impact
Analysis; Initial Regulatory Flexibility
VerDate Sep<11>2014
23:42 Dec 18, 2020
Jkt 253001
Analysis; Unfunded Mandates Reform Act
Analysis, Revocation of the Regulations for
Human Tissue Intended for Transplantation;
Proposed Rule’’ dated March 24, 2020. Also
available at: https://www.fda.gov/about-fda/
reports/economic-impact-analyses-fdaregulations.
List of Subjects
21 CFR Part 882
Medical devices, Neurological
devices.
21 CFR Part 1270
Communicable diseases, HIV/AIDS,
Reporting and recordkeeping
requirements.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and the Public
Health Service Act, it is proposed that
21 CFR parts 882 and 1270 are amended
as follows:
PART 882—NEUROLOGICAL DEVICES
1. The authority citation for part 882
continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 360l, 371.
§ 882.5975
■
[Removed]
2. Remove § 882.5975.
PART 1270—[REMOVED]
3. Under the authority of 42 U.S.C.
216, 243, 264, 271, 21 CFR part 1270 is
removed.
■
Dated: December 2, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
Dated: December 11, 2020
Alex M. Azar II,
Secretary, Department of Health and Human
Services.
[FR Doc. 2020–27828 Filed 12–18–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF EDUCATION
34 CFR Part 300
[Docket ID ED–2020–OSERS–0191]
Proposed Guidance; Questions and
Answers on Serving Children With
Disabilities Placed by Their Parents in
Private Schools
Office of Special Education and
Rehabilitative Services, Department of
Education.
ACTION: Notice of proposed guidance.
AGENCY:
The U.S. Department of
Education (Department) seeks public
comment on proposed guidance that
addresses State and local
responsibilities under Part B of the
SUMMARY:
PO 00000
Frm 00045
Fmt 4702
Sfmt 4702
Individuals with Disabilities Education
Act (IDEA) for providing equitable
services to parentally placed private
school children with disabilities. The
proposed guidance updates and
supersedes the Department’s guidance
titled Questions and Answers on
Serving Children with Disabilities
Placed by Their Parents in Private
Schools issued in April 2011.
DATES: We must receive your comments
on or before January 20, 2021.
ADDRESSES: Submit your comments
through the Federal eRulemaking Portal.
We will not accept comments submitted
by mail, fax, or by email or those
submitted after the comment period. To
ensure that we do not receive duplicate
copies, please submit your comments
only once. In addition, please include
the Docket ID at the top of your
comments.
• Federal eRulemaking Portal: Go to
www.regulations.gov to submit your
comments electronically. Information
on using Regulations.gov, including
instructions for accessing agency
documents, submitting comments, and
viewing the docket, is available on the
site under ‘‘Help.’’
Privacy Note: The Department’s
policy is to make all comments received
from members of the public available for
public viewing in their entirety on the
Federal eRulemaking Portal at
www.regulations.gov. Therefore,
commenters should be careful to
include in their comments only
information that they wish to make
publicly available.
FOR FURTHER INFORMATION CONTACT:
Rebecca Walawender, U.S. Department
of Education, 400 Maryland Avenue
SW, Room 5145, Washington, DC
20202–5076. Telephone: (202) 245–
7399. Email: Rebecca.Walawender@
ed.gov.
SUPPLEMENTARY INFORMATION:
Invitation to Comment: We invite you
to submit comments on the proposed
guidance. See ADDRESSES for
instructions on how to submit
comments.
Assistance to Individuals with
Disabilities in Reviewing the Record: On
request, we will provide an appropriate
accommodation or auxiliary aid to an
individual with a disability who needs
assistance to review the comments or
other documents in the public record for
the proposed guidance. If you want to
schedule an appointment for this type of
aid, please contact the person listed
under FOR FURTHER INFORMATION
CONTACT.
Background: The Department
describes the background for the
proposed guidance, and our reasons for
E:\FR\FM\21DEP1.SGM
21DEP1
]]>Agencies
[Federal Register Volume 85, Number 245 (Monday, December 21, 2020)]
[Proposed Rules]
[Pages 82990-82994]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-27828]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 882 and 1270
[Docket No. FDA-2020-N-1519]
RIN 0910-AI41
Revocation of the Regulations for Human Tissue Intended for
Transplantation and Human Dura Mater
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
proposing to revoke the regulations for human tissue intended for
transplantation and human dura mater recovered prior to May 25, 2005.
The proposed revocation does not affect the regulations for human
cells, tissues, and cellular and tissue-based products (HCT/Ps)
recovered on or after May 25, 2005. FDA is proposing this action
because these regulations are obsolete or no longer necessary to
achieve public health goals. This action is part of FDA's
implementation of Executive Orders 13771 and 13777. Under these
Executive Orders, FDA is comprehensively reviewing existing regulations
to identify opportunities for repeal, replacement, or modification that
will result in meaningful burden reduction, while allowing the Agency
to achieve our public health mission and fulfill statutory obligations.
DATES: Submit either electronic or written comments on the proposed
rule by March 8, 2021.
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 8, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of March 8, 2021. 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-2020-N-1519 for ``Revocation of the Regulations for Human Tissue
Intended for Transplantation.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' will be publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS
[[Page 82991]]
CONFIDENTIAL INFORMATION.'' The Agency will review this copy, including
the claimed confidential information, in its consideration of comments.
The second copy, which will have the claimed confidential information
redacted/blacked out, will be available for public viewing and posted
on https://www.regulations.gov. Submit both copies to the Dockets
Management Staff. If you do not wish your name and contact information
to be made publicly available, you can provide this information on the
cover sheet and not in the body of your comments and you must identify
this information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Shruti Modi, 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.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Executive Summary
A. Purpose of the Proposed Rule
B. Summary of the Major Provisions of the Proposed Rule
C. Legal Authority
D. Costs and Benefits
II. Background
A. Introduction
B. Need for Regulation/History of Regulation
C. Applicability of Sec. 882.5975 and Part 1270
III. Legal Authority
IV. Description of the Proposed Rule
V. Proposed Effective Date
VI. Preliminary Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. Consultation and Coordination With Indian Tribal Governments
XI. References
I. Executive Summary
A. Purpose of the Proposed Rule
FDA proposes to remove the regulations under part 1270 (21 CFR part
1270), ``Human Tissue Intended for Transplantation'' and Sec. 882.5975
(21 CFR 882.5975), ``Human dura mater.'' These regulations apply to
certain tissues recovered prior to May 25, 2005. The Agency does not
believe there are currently any tissues intended for transplantation
remaining in inventory that were recovered prior to this date and that
would be subject to these regulations. Therefore, the regulations under
this part are outdated and obsolete. All HCT/Ps recovered on or after
May 25, 2005, are subject to the regulations under part 1271 (21 CFR
part 1271), ``Human Cells, Tissues, and Cellular and Tissue-Based
Products.''
B. Summary of the Major Provisions of the Proposed Rule
The proposed rule would remove part 1270 ``Human Tissue Intended
for Transplantation,'' which applies to certain human tissue and to
establishments or persons engaged in the recovery, screening, testing,
processing, storage, or distribution of human tissue. It would also
remove Sec. 882.5975, ``Human dura mater,'' which identifies and
classifies Human dura mater recovered prior to May 25, 2005.
C. Legal Authority
FDA is taking this action under the communicable disease provisions
of the Public Health Service Act (the PHS Act) and the device
provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act).
D. Costs and Benefits
Because this proposed rule would not impose any additional burden
on the industry, this regulation is not anticipated to result in any
compliance costs. The costs and cost savings to FDA resulting from
removing an obsolete regulation are expected to be minimal.
II. Background
A. Introduction
On February 24, 2017, Executive Order 13777, entitled ``Enforcing
the Regulatory Reform Agenda'' (https://www.federalregister.gov/documents/2017/03/01/2017-04107/enforcing-the-regulatory-reform-agenda,
82 FR 12285, March 1, 2017) was issued. One of the provisions of the
Executive Order requires Agencies to evaluate existing regulations and
make recommendations to the Agency head regarding their repeal,
replacement, or modification, consistent with applicable law. As part
of this initiative, FDA is proposing to revoke certain regulations as
specified in this proposed rule.
B. Need for Regulation/History of Rulemaking
FDA regulates articles containing or consisting of human cells or
tissues intended for implantation, transplantation, infusion, or
transfer into a human recipient. These are defined in Sec. 1271.3(d)
as HCT/Ps. Tissues as defined in Sec. 1270.3(j) recovered prior to May
25, 2005, are regulated under part 1270. HCT/Ps recovered on or after
May 25, 2005, are subject to the regulations in part 1271. Examples of
HCT/Ps include, but are not limited to the following: bone, ligament,
skin, cornea, ligament, dura mater, heart valve, hematopoietic stem/
progenitor cells derived from peripheral and cord blood, and semen or
other reproductive tissue. Vascularized human organs for
transplantation are not considered HCT/Ps. FDA currently regulates
human dura mater recovered prior to May 25, 2005, under Sec. 882.5975.
In the Federal Register of December 14, 1993 (58 FR 65514), FDA
published an interim rule (1993 interim rule) for Human Tissue Intended
for Transplantation. This rule provided specific donor suitability and
testing requirements for certain tissue products. As the use of human
tissue for transplantation increased, FDA determined that there was a
need for a much more comprehensive set of regulatory requirements that
included a broader scope of products. In the Federal Register of July
29, 1997 (62 FR 40429), FDA issued a final rule which clarified and
modified provisions of the 1993 interim rule.
In the Federal Register of March 4, 1997 (62 FR 9721), FDA
announced the availability of a document entitled ``Proposed Approach
to the Regulation of Cellular and Tissue-Based Products.'' The purpose
was to develop a plan to address the regulation of human cellular and
tissue-based products in a more comprehensive, but not unduly
burdensome manner. The plan detailed how cellular and tissue-based
products would be regulated with a tiered approach based on risk and
the necessity for FDA review.
As part of this approach, FDA advanced three regulatory proposals
including: (1) Registration and Listing; (2) Communicable-Disease
Screening and Testing; and (3) Processing Standards. FDA published
three final rules to implement the proposed approach as follows:
(1) ``Human Cells, Tissues, and Cellular and Tissue-Based Products;
[[Page 82992]]
Establishment Registration and Listing'' (66 FR 5447, January 19,
2001), which set forth part 1271, subpart A (General Provisions) and
subpart B (Procedures for Registration and Listing) (effective dates
April 4, 2001, and January 21, 2004 based on the applicability of the
HCT/P establishment). The final rule requires HCT/P establishments to
register with the Agency and list the HCT/Ps they manufacture.
(2) ``Eligibility Determination for Donors of Human Cells, Tissues,
and Cellular and Tissue-Based Products'' (69 FR 29786, May 25, 2004),
which set forth part 1271, subpart C (Donor Eligibility) (effective
date May 25, 2005). The final rule requires HCT/P establishments to
screen and test cell and tissue donors for risk factors for, and
clinical evidence of, relevant communicable disease agents and
diseases.
(3) ``Current Good Tissue Practice for Human Cell, Tissue, and
Cellular and Tissue-Based Product Establishments, Inspection and
Enforcement'' (69 FR 68611, November 24, 2004), which set forth part
1271, subpart D (Current Good Tissue Practice), subpart E (Additional
Requirements for Establishments Described in Sec. 1271.10), and
subpart F (Inspection and Enforcement of Establishments Described in
Sec. 1271.10) (effective date May 25, 2005). The final rule requires
HCT/P establishments to follow current good tissue practice, which
governs the methods used in, and the facilities and controls used for,
the manufacture of HCT/Ps; recordkeeping; and the establishment of a
quality program.
FDA issued these regulations to increase the safety of HCT/Ps, and
public confidence in their safety, by helping to prevent the
introduction, transmission, and spread of communicable disease. The
regulations were issued to protect the public health while minimizing
regulatory burden, which in turn would encourage significant
innovation.
C. Applicability of Sec. 882.5975 and Part 1270
The Agency did not revoke part 1270 at the same time the Agency
proposed part 1271 because it would have been impractical to apply part
1271 retroactively to human tissue, as defined in Sec. 1270.3(j), that
was recovered before the effective date of the final rule. Instead, the
Agency decided that human tissue, as defined in Sec. 1270.3(j), that
was recovered prior to May 25, 2005, would remain subject to the
regulations in part 1270. However, in the final rules applicable to
HCT/Ps (66 FR 5447 and 5448; 69 FR 68611), FDA noted its intention to
revoke part 1270 in the future when we were confident that there was no
human tissue regulated under part 1270 available for use.
Part 1270 applies only to human tissue defined in Sec. 1270.3(j)
and recovered prior to May 25, 2005. The device classification set
forth in 21 CFR 882.5975, ``Human dura mater,'' is only applicable to
human dura mater recovered prior to May 25, 2005. Human dura mater
recovered on or after May 25, 2005, is subject to the regulations in
part 1271 when an establishment does not qualify for any of the
exceptions in Sec. 1271.15. Further, human dura mater is regulated
solely under section 361 of the PHS Act and part 1271 when the HCT/P
meets all the criteria set out in Sec. 1271.10(a). Otherwise the HCT/P
is regulated as a drug, device, and/or biological product under the
FD&C Act, and/or section 351 of the PHS Act, and applicable
regulations, including part 1271.
Products that meet the definition of an HCT/P in Sec. 1271.3(d)
that are recovered on or after May 25, 2005, including those that have
been regulated after May 25, 2005, as drugs, devices, and/or biological
products under section 351 of the PHS Act and/or the FD&C Act will not
be affected by revocation of part 1270.
We do not believe there are currently any tissues intended for
transplantation remaining in inventory that were recovered prior to May
25, 2005, that would be subject to these regulations. Therefore, the
regulations under Sec. 882.5975 and part 1270 are outdated and
obsolete.
III. Legal Authority
FDA is issuing this proposed rule under the communicable disease
provisions of the PHS Act, which provide FDA with the authority to
issue and enforce regulations designed to prevent the introduction,
transmission, and spread of communicable disease (42 U.S.C. 216, 243,
264, 271), and provisions of the FD&C Act applicable to devices (21
U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371)).
IV. Description of the Proposed Rule
Part 1270 became effective in 1997, and applies only to human
tissue defined in Sec. 1270.3(j) and recovered prior to May 25, 2005.
It is highly unlikely there is any human tissue regulated under part
1270 remaining in inventory today that is suitable for human
transplantation. This regulation is outdated and has been replaced with
part 1271.
V. Proposed Effective Date
FDA is proposing that any final rule based on the proposed rule
become effective 30 days after the date of its publication in the
Federal Register.
VI. Preliminary Economic Analysis of Impacts
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 the proposed rule, if finalized, would not create new
regulatory responsibilities for small entities, 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 $156 million, using the most current (2019) 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.
This proposed rule, if finalized, would remove the obsolete
regulations under part 1270 for human tissue intended for
transplantation into a human recipient and Sec. 882.5975 for human
dura matter. These regulations
[[Page 82993]]
only apply to tissue derived from a human body and recovered prior to
May 25, 2005. We believe it is highly unlikely any such human tissues
remain available for use today. The proposed rule therefore is not
anticipated to result in any compliance costs to the industry. We
expect the economic impact on the FDA resulting from removing an
obsolete regulation to be minimal.
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 would be $0 at both the 3 and
7 percent discount rate. The present value of the estimated benefits
(i.e., cost savings) of the proposed rule would also be $0 at both the
3 and 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 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
ollars rate (years)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Benefits:
Annualized Monetized $millions/year........ $0 $0 $0 2019 7 10
0 0 0 2019 3 10
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Quantified......................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Qualitative................................ Field investigators would no
longer need to reference the
obsolete regulations, resulting in
very minor cost savings for FDA in
terms of employee time.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs:
Annualized Monetized millions/year......... 0 0 0 2019 7 10
0 0 0 2019 3 10
Annualized Quantified...................... .......... .......... .......... .......... 7
3
--------------------------------------------------------------------------------------------------------------------------------------------------------
Qualitative................................
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
Federal Annualized Monetized millions/year. .......... .......... .......... .......... 7
3
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To.................................... From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Other Annualized Monetized millions/year... .......... .......... .......... .......... 7
3
--------------------------------------------------------------------------------------------------------------------------------------------------------
From/To.................................... From:
To:
--------------------------------------------------------------------------------------------------------------------------------------------------------
Effects:
State, Local or Tribal Government: None.
Small Business: None.
Wages: None.
Growth: None.
--------------------------------------------------------------------------------------------------------------------------------------------------------
In line with Executive Order 13771, in table 2 we estimate present
and annualized values of costs and cost savings over an infinite time
horizon. The present value of the net costs and cost savings would be
$0 at both 3 and 7 percent discount rate.
Table 2--Executive Order 13771 Summary Table
[In $ millions 2016 dollars, over an infinite time horizon]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Primary Lower estimate Upper estimate Primary Lower estimate Upper estimate
Item estimate (7%) (7%) (7%) estimate (3%) (3%) (3%)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Present Value of Costs.................................. $0 $0 $0 $0 $0 $0
Present Value of Cost Savings........................... 0 0 0 0 0 0
Present Value of Net Costs.............................. 0 0 0 0 0 0
Annualized Costs........................................ 0 0 0 0 0 0
Annualized Cost Savings................................. 0 0 0 0 0 0
Annualized Net Costs.................................... 0 0 0 0 0 0
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 https://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.
[[Page 82994]]
VII. Analysis of Environmental Impact
We have determined under 21 CFR 25.31(h) that this action is of a
type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VIII. 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 Paper Reduction Act of 1995 is not
required.
IX. Federalism
We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the 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 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.
X. 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.
XI. References
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.
1. FDA, ``Preliminary Regulatory Impact Analysis; Initial
Regulatory Flexibility Analysis; Unfunded Mandates Reform Act
Analysis, Revocation of the Regulations for Human Tissue Intended
for Transplantation; Proposed Rule'' dated March 24, 2020. Also
available at: https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
List of Subjects
21 CFR Part 882
Medical devices, Neurological devices.
21 CFR Part 1270
Communicable diseases, HIV/AIDS, Reporting and recordkeeping
requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and the
Public Health Service Act, it is proposed that 21 CFR parts 882 and
1270 are amended as follows:
PART 882--NEUROLOGICAL DEVICES
0
1. The authority citation for part 882 continues to read as follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.
Sec. 882.5975 [Removed]
0
2. Remove Sec. 882.5975.
PART 1270--[REMOVED]
0
3. Under the authority of 42 U.S.C. 216, 243, 264, 271, 21 CFR part
1270 is removed.
Dated: December 2, 2020.
Stephen M. Hahn,
Commissioner of Food and Drugs.
Dated: December 11, 2020
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-27828 Filed 12-18-20; 8:45 am]
BILLING CODE 4164-01-P
