[Federal Register Volume 87, Number 9 (Thursday, January 13, 2022)]
[Rules and Regulations]
[Pages 2045-2049]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-00492]
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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: Final rule.
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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
issuing a final rule to revoke the regulations for human tissue
intended for transplantation and human dura mater recovered prior to
May 25, 2005. The 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. The rule is being finalized because
these regulations are obsolete or no longer necessary to achieve public
health goals.
DATES: This rule is effective February 14, 2022.
ADDRESSES: For access to the docket to read background documents or
comments received, go to https://www.regulations.gov and insert the
[[Page 2046]]
docket number found in brackets in the heading of this final rule 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 Final Rule
B. Summary of the Major Provisions of the Final Rule
C. Legal Authority
D. Costs and Benefits
II. Background
A. Introduction
B. Need for Regulation/History of Rulemaking
C. Applicability of Sec. 882.5975 and Part 1270
D. Comments to the Proposed Rule
III. Legal Authority
IV. Effective Date
V. Economic Analysis of Impacts
A. Introduction
B. Summary of Costs and Benefits
VI. Analysis of Environmental Impact
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 Final Rule
FDA is removing 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 Final Rule
The final rule removes 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 also removes
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 (FD&C Act).
D. Costs and Benefits
Because this final rule will not impose any additional burden on
the industry, this regulation is not anticipated to result in any
compliance costs and the economic impact is expected to be minimal.
II. Background
A. Introduction
FDA is issuing a final rule to revoke the regulations for human
tissue intended for transplantation (part 1270) and human dura mater
(Sec. 882.5975) recovered prior to May 25, 2005, because these
regulations are obsolete or no longer necessary to achieve public
health goals. The 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.
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)
(21 CFR 1271.3(d)) as HCT/Ps. Tissues as defined in Sec. 1270.3(j) (21
CFR 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, 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 previously regulated human dura mater recovered prior to May
25, 2005, under Sec. 882.5975 subject to special controls and
premarket notification.\1\
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\1\ The special controls for human dura matter recovered prior
to May 25, 2005, can be found in ``Class II Special Controls
Guidance Document: Human Dura Mater--Guidance for Industry and FDA
Staff'', available at https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/class-ii-special-controls-guidance-document-human-dura-mater-guidance-industry-and-fda-staff.
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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 that 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'' that 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, which are
codified in part 1271 as follows: (1) ``Human Cells, Tissues, and
Cellular and Tissue-Based Products; Establishment Registration and
Listing'' (66 FR 5447, January 19, 2001); (2) ``Eligibility
Determination for Donors of Human Cells, Tissues, and Cellular and
Tissue-Based Products'' (69 FR 29786, May 25, 2004); and (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).
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
[[Page 2047]]
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 at 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 Sec. 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 21 CFR 1271.15. Further, human dura mater is regulated
solely under section 361 of the PHS Act (42 U.S.C. 264) and part 1271
when the HCT/P meets all the criteria set out in 21 CFR 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 (42
U.S.C. 262), 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 its accompanying special control
guidance, and the regulations under part 1270 are outdated and
obsolete.
D. Comments to the Proposed Rule
In the Federal Register of December 21, 2020 (85 FR 82990), FDA
published a proposed rule entitled ``Revocation of the Regulations for
Human Tissue Intended for Transplantation and Human Dura Mater'' to
revoke the regulations for human tissue intended for transplantation
and human dura mater recovered prior to May 25, 2005. We did not
receive any comments on the proposed rule. Therefore, we are finalizing
the proposed rule without change.
III. Legal Authority
FDA is issuing this final 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, and 271), and provisions of the FD&C Act applicable to devices (21
U.S.C. 351, 360, 360c, 360e, 360j, 360l, and 371)).
IV. Effective Date
This final rule will become effective 30 days after the date of its
publication in the Federal Register.
V. Economic Analysis of Impacts
A. Introduction
We have examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, 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). We
believe that this final 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 rule will not create new regulatory
responsibilities for small entities, we certify that the 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 issuing ``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 $158
million, using the most current (2020) Implicit Price Deflator for the
Gross Domestic Product. This final rule would not result in an
expenditure in any year that meets or exceeds this amount.
B. Summary of Costs and Benefits
This final rule will 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
only apply to certain 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 final rule, therefore, is
not anticipated to result in any compliance costs to the industry. We
expect the economic impact on FDA resulting from removing an obsolete
regulation to be minimal.
Table 1 summarizes the estimated benefits and costs of the final
rule. Annualized over 10 years, the estimated benefits (i.e. cost
savings) of the final rule will be $0 at both the 3 and 7 percent
discount rate. The present value of the estimated benefits (i.e., cost
savings) of the final rule will also be $0 at both the 3 and 7 percent
discount rate. The annualized costs of the final rule will be $0 at
both 3 and 7 percent discount rate. The present value of costs of the
final rule will also be $0 at both 3 and 7 percent discount rate.
Table 1--Summary of Benefits, Costs, and Distributional Effects of Final Rule
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Units
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Category Primary Low High Period Notes
estimate estimate estimate Year Discount covered
dollars rate (%) (years)
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Benefits:
Annualized Monetized $millions/year... $0 $0 $0 2020 7 10
0 0 0 2020 3 10
Annualized Quantified................. .......... .......... .......... .......... .......... ..........
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[[Page 2048]]
Qualitative........................... Field investigators will no longer
need to reference the obsolete
regulations, resulting in very
minor cost savings for FDA in
terms of employee time.
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Costs:
Annualized Monetized $millions/year... 0 0 0 2020 7 10
0 0 0 2020 3 10
Annualized Quantified................. .......... .......... .......... .......... 7 ..........
.......... .......... .......... .......... 3 ..........
Qualitative............................... .......... .......... .......... .......... .......... ..........
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Transfers:
Federal Annualized Monetized $millions/ .......... .......... .......... .......... 7 ..........
year.
.......... .......... .......... .......... 3 ..........
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From/To............................... From:
To:
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Other Annualized Monetized $millions/ .......... .......... .......... .......... 7 ..........
year.
.......... .......... .......... .......... 3 ..........
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From/To
From:
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Effects:
State, Local or Tribal Government: None.............................................................................................................
Small Business: None................................................................................................................................
Wages: None.........................................................................................................................................
Growth: None........................................................................................................................................
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FDA has examined the economic implications of the rule as required
by the Regulatory Flexibility Act. If a rule will have a significant
economic impact on a substantial number of small entities, the
Regulatory Flexibility Act requires us to analyze regulatory options
that would lessen the economic effect of the rule on small entities.
This rule will not impose any new burdens on small entities, and thus
will not impose a significant economic impact on a substantial number
of small entities.
We have developed a comprehensive Economic Analysis of Impacts that
assesses the impacts of the final rule. The full analysis of economic
impacts is available in the docket for this final rule (Ref. 1) and at
https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
VI. 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.
VII. Paperwork Reduction Act of 1995
This final 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 final rule in accordance with the principles
set forth in Executive Order 13132. We have determined that the 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.
IX. Consultation and Coordination With Indian Tribal Governments
We have analyzed this final rule in accordance with the principles
set forth in Executive Order 13175. We have determined that the rule
does not contain policies that have substantial direct effects 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.
Accordingly, we conclude that the rule does not contain policies that
have tribal implications as defined in the Executive Order and,
consequently, a tribal summary impact statement is not required.
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.
1. FDA, Final Regulatory Impact Analysis; Final Regulatory
Flexibility Analysis; Unfunded Mandates Reform Act Analysis,
Revocation of the Regulations for Human Tissue Intended for
Transplantation; Final Rule. Also available at: https://www.fda.gov/about-fda/reports/economic-impact-analyses-fda-regulations.
List of Subjects
21 CFR Part 882
Medical 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, and under authority delegated to the
Commissioner of Food
[[Page 2049]]
and Drugs, 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, part 1270 is
removed.
Dated: January 6, 2022.
Janet Woodcock,
Acting Commissioner of Food and Drugs.
[FR Doc. 2022-00492 Filed 1-12-22; 8:45 am]
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