[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

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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
                                                                               ------------------------------------
                 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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    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...............................  ..........  ..........  ..........  ..........  ..........  ..........
--------------------------------------------------------------------------------------------------------------------------------------------------------
Transfers:
    Federal Annualized Monetized $millions/ ..........  ..........  ..........  ..........           7  ..........
     year.
                                            ..........  ..........  ..........  ..........           3  ..........
                                           -------------------------------------------------------------------------------------------------------------
    From/To...............................  From:
                                            To:
                                           -------------------------------------------------------------------------------------------------------------
    Other Annualized Monetized $millions/   ..........  ..........  ..........  ..........           7  ..........
     year.
                                            ..........  ..........  ..........  ..........           3  ..........
                                           -------------------------------------------------------------------------------------------------------------
                                            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]
BILLING CODE 4164-01-P