[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]


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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: Proposed rule.

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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......................
 
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    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]
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