Recommendations on In Vitro Ocular Safety Testing Methods and Strategies and Routine Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints for Ocular Safety Testing, 20672-20673 [2011-8938]

Download as PDF 20672 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices Abstract: The results of the HHS Web Site Customer Satisfaction Survey will be used to ensure that the content on the HHS Web sites meets visitor needs and expectations. The results will also determine if the site is easy to use and the content easy to understand. ESTIMATED ANNUALIZED BURDEN TABLE Number of respondents Form Survey .............................................................................................................. Mary Forbes, Office of the Secretary, Paperwork Reduction Act Reports Clearance Officer. [FR Doc. 2011–8796 Filed 4–12–11; 8:45 am] BILLING CODE 4150–25–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Recommendations on In Vitro Ocular Safety Testing Methods and Strategies and Routine Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints for Ocular Safety Testing National Institute of Environmental Health Sciences (NIEHS), National Institutes of Health (NIH). ACTION: Notice of availability. AGENCY: U.S. Federal agency responses to ICCVAM test method recommendations on alternative testing methods and strategies proposed to further reduce and refine the use of animals for assessing the ocular hazard potential of chemicals and products are now available. ICCVAM recommended a pain management procedure that should always be used to avoid pain and distress when it is determined necessary to conduct the rabbit eye test for regulatory safety purposes. ICCVAM also recommended the Cytosensor Microphysiometer (CM) test method as a screening test (1) to identify some types of substances that will not cause sufficient injury to require eye hazard labeling and (2) to identify some types of substances that may cause permanent or severe eye injuries. ICCVAM previously forwarded recommendations to Federal agencies and made these recommendations available to the public (75 FR 57027). In accordance with the ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3), agencies have notified ICCVAM in writing of their findings and ICCVAM is making these responses available to the public. Federal agency responses are available on the NICEATM–ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/ mstockstill on DSKH9S0YB1PROD with NOTICES SUMMARY: VerDate Mar<15>2010 18:37 Apr 12, 2011 Jkt 223001 48,000 ocutox/Transmit-2010.htm. The ICCVAM recommendations are provided in ICCVAM test method evaluation reports that are available on the NICEATM–ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/ ocutox/OcuAnest-TMER.htm, https:// iccvam.niehs.nih.gov/methods/ocutox/ MildMod-TMER.htm, https:// iccvam.niehs.nih.gov/methods/ocutox/ AMCP–TMER.htm, and https:// iccvam.niehs.nih.gov/methods/ocutox/ LVET.htm. FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director, NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2– 16, Research Triangle Park, NC 27709, (telephone) 919–541–2384, (fax) 919– 541–0947, (e-mail) niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530 Davis Drive, Morrisville, NC 27560. SUPPLEMENTARY INFORMATION: Background The U.S. Environmental Protection Agency (EPA) requested that ICCVAM (1) evaluate the current validation status of the bovine corneal opacity and permeability (BCOP), hen’s egg test– chorioallantoic membrane (HET–CAM), isolated chicken eye (ICE), and isolated rabbit eye (IRE) test methods; (2) identify in vivo ocular toxicity reference data to support the validation of in vitro test methods; (3) explore ways of alleviating pain and distress from current in vivo ocular safety testing; and (4) review the state of the science and the availability of in vitro test methods for assessing mild or moderate ocular irritants. The highest priority activity, an evaluation of the BCOP, HET–CAM, ICE, and IRE test methods for their usefulness and limitations for identifying potential ocular corrosives and severe irritants, was completed in 2006 (NIH Publication No. 07–4517). Based on this evaluation, U.S. Federal agencies subsequently accepted the BCOP and ICE test methods for certain regulatory testing purposes without the need for animal testing. The Organisation for Economic Co-operation and Development (OECD) subsequently PO 00000 Frm 00050 Fmt 4703 Sfmt 4703 Number of responses per respondent 1 Average burden hours per response (in hrs.) Total burden hours 12/60 9,600 adopted the BCOP and ICE test methods in 2009 as international OECD Test Guidelines 437 and 438, respectively (OECD 2009a, OECD 2009b). The International Organization for Standardization (ISO) adopted the BCOP and ICE test methods as ISO Standard 10993–10 in 2010 (ISO 2010). ICCVAM recently completed additional test method evaluations relevant to the original EPA nomination and a subsequent EPA request that ICCVAM evaluate a proposed in vitro testing strategy for identifying the ocular hazard potential of antimicrobial cleaning products. Information is provided about ICCVAM’s evaluation and the committee’s recommendations for the alternative testing methods and strategies proposed to further reduce and refine the use of animals for assessing the ocular hazard potential of chemicals and products in four ICCVAM Test Method Evaluation Reports: (1) Recommendations for Routine Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints to Avoid or Minimize Pain and Distress in Ocular Safety Testing (NIH Publication No. 10–7514), (2) Current Validation Status of In Vitro Test Methods Proposed for Identifying Eye Injury Hazard Potential of Chemicals and Products (NIH Publication No. 10–7553), (3) Current Validation Status of a Proposed In Vitro Testing Strategy for U.S. Environmental Protection Agency Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products (NIH Publication No. 10–7513), and (4) Recommendation to Discontinue Use of the Low Volume Eye Test for Ocular Safety Testing (NIH Publication No. 10–7515). Agency Responses to ICCVAM Recommendations In September 2010, ICCVAM forwarded final test method recommendations for ocular safety testing methods and strategies to U.S. Federal agencies for consideration, in accordance with the ICCVAM Authorization Act of 2000 (42 U.S.C. E:\FR\FM\13APN1.SGM 13APN1 Federal Register / Vol. 76, No. 71 / Wednesday, April 13, 2011 / Notices mstockstill on DSKH9S0YB1PROD with NOTICES 285l–3) (75 FR 57027). The ICCVAM Authorization Act requires member agencies to review ICCVAM test method recommendations and notify ICCVAM in writing of their findings no later than 180 days after receipt of recommendations. The Act also requires ICCVAM to make ICCVAM recommendations and agency responses available to the public. Agency responses should include identification of relevant test methods for which the ICCVAM test method recommendations may be added or substituted and indicate any revisions or planned revisions to existing guidelines, guidances, or regulations to be made in response to these recommendations. ICCVAM agencies concurred with the test method recommendations for the in vitro ocular safety testing methods and strategies and support the routine use of topical anesthetics, systemic analgesics, and humane endpoints for ocular safety testing. Several agencies also indicated that they would communicate the ICCVAM recommendations to stakeholders and encourage their appropriate use. Agency responses are available at https://iccvam.niehs.nih.gov/ methods/ocutox/Transmit-2010.htm. Background Information on ICCVAM and NICEATM ICCVAM is an interagency committee composed of representatives from 15 Federal regulatory and research agencies that require, use, generate, or disseminate toxicological and safety testing information. ICCVAM conducts technical evaluations of new, revised, and alternative safety testing methods with regulatory applicability and promotes the scientific validation and regulatory acceptance of toxicological and safety testing methods that more accurately assess the safety and hazards of chemicals and products and that reduce, refine (decrease or eliminate pain and distress), or replace animal use. The ICCVAM Authorization Act of 2000 (42 U.S.C. 285l–3) established ICCVAM as a permanent interagency committee of the NIEHS under NICEATM. NICEATM administers ICCVAM, provides scientific and operational support for ICCVAM-related activities, and conducts independent validation studies to assess the usefulness and limitations of new, revised, and alternative test methods and strategies. NICEATM and ICCVAM work collaboratively to evaluate new and improved test methods and strategies applicable to the needs of U.S. Federal agencies. NICEATM and ICCVAM welcome the public nomination of new, revised, and alternative test methods and strategies VerDate Mar<15>2010 18:37 Apr 12, 2011 Jkt 223001 for validation studies and technical evaluations. Additional information about ICCVAM and NICEATM can be found on the NICEATM–ICCVAM Web site (https://iccvam.niehs.nih.gov). References ICCVAM. 2006. ICCVAM Test Method Evaluation Report: In Vitro Ocular Toxicity Test Methods for Identifying Severe Irritants and Corrosives. NIH Publication No. 07– 4517. Research Triangle Park, NC: NIEHS. Available: https://iccvam.niehs.nih.gov/methods/ ocutox/ivocutox/ocu_tmer.htm. ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Recommendations for Routine Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints to Avoid or Minimize Pain and Distress in Ocular Safety Testing. NIH Publication No. 10–7514. Research Triangle Park, NC: NIEHS. Available: https://iccvam.niehs.nih.gov/methods/ ocutox/OcuAnest-TMER.htm. ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Current Validation Status of In Vitro Test Methods Proposed for Identifying Eye Injury Hazard Potential of Chemicals and Products. NIH Publication No. 10–7553. Research Triangle Park, NC: NIEHS. Available: https://iccvam.niehs.nih.gov/methods/ ocutox/MildMod-TMER.htm. ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Current Validation Status of a Proposed In Vitro Testing Strategy for U.S. Environmental Protection Agency Ocular Hazard Classification and Labeling of Antimicrobial Cleaning Products. NIH Publication No. 10– 7513. Research Triangle Park, NC: NIEHS. Available: https://iccvam.niehs.nih.gov/methods/ ocutox/AMCP-TMER.htm. ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Recommendation to Discontinue Use of The Low Volume Eye Test for Ocular Safety Testing. NIH Publication No. 10–7515. Research Triangle Park, NC: NIEHS. Available: https://iccvam.niehs.nih.gov/methods/ ocutox/LVET.htm. ISO. 2010. Biological evaluation of medical devices—10993 Part 10: Tests for irritation and skin sensitization. Available for purchase at: https:// www.iso.org/iso/home.htm. OECD. 2009a. Test Guideline 437. Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants, adopted September 2009. In: OECD Guidelines for Testing of Chemicals. Paris: OECD. Available: https://www.oecd-ilibrary.org/ environment/test-no-437-bovine-cornealopacity-and-permeability-test-methodfor-identifying-ocular-corrosives-andsevere-irritants_9789264076303-en. OECD. 2009b. Test Guideline 438. Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants, adopted September 2009. In: OECD Guidelines for Testing of Chemicals. Paris: OECD. Available: https:// PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 20673 www.oecd-ilibrary.org/environment/testno-438-isolated-chicken-eye-testmethod-for-identifying-ocular-corrosivesand-severe-irritants_9789264076310-en. Dated: April 1, 2011. John R. Bucher, Associate Director, National Toxicology Program. [FR Doc. 2011–8938 Filed 4–12–11; 8:45 am] BILLING CODE 4140–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [CMS–7031–NC] Announcement of Notice; Proposed Establishment of a Federally Funded Research and Development Center— First Notice Centers for Medicare & Medicaid Services (CMS), Department of Health & Human Services (DHHS). ACTION: Notice. AGENCY: This notice announces our intention to sponsor Federally Funded Research and Development Center (FFRDC) to facilitate the modernization of business processes and supporting systems and their operations. This is the first of three notices which must be published over a 90-day period in order to advise the public of the agency’s intention to sponsor an FFRDC issued under the authority of 48 CFR 35.017. DATES: We must receive comments on or before July 5, 2011. ADDRESSES: Comments on this notice must be mailed to the Centers for Medicare & Medicaid Services, Candice Savoy, Contracting Officer, 7500 Security Boulevard, Mailstop C2–01–10, Baltimore, MD 21244 or e-mail at Candice.Savoy@cms.hhs.gov. FOR FURTHER INFORMATION CONTACT: Candice Savoy, (410) 786–7494. SUPPLEMENTARY INFORMATION: The Centers for Medicare & Medicaid Services (CMS), an operating division within the Department of Health and Human Services (DHHS), intends to sponsor a studies and analysis, Delivery System, Simulations, and Cost Modeling Federally Funded Research and Development Center (FFRDC) to facilitate the modernization of business processes and supporting systems and their operations. Some of the broad task areas that will be utilized include Strategic/Tactical Planning, Conceptual Planning, Design and Engineering, Procurement Assistance, Organizational Planning, Research and Development, SUMMARY: E:\FR\FM\13APN1.SGM 13APN1

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[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20672-20673]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-8938]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES


Recommendations on In Vitro Ocular Safety Testing Methods and 
Strategies and Routine Use of Topical Anesthetics, Systemic Analgesics, 
and Humane Endpoints for Ocular Safety Testing

AGENCY: National Institute of Environmental Health Sciences (NIEHS), 
National Institutes of Health (NIH).

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: U.S. Federal agency responses to ICCVAM test method 
recommendations on alternative testing methods and strategies proposed 
to further reduce and refine the use of animals for assessing the 
ocular hazard potential of chemicals and products are now available. 
ICCVAM recommended a pain management procedure that should always be 
used to avoid pain and distress when it is determined necessary to 
conduct the rabbit eye test for regulatory safety purposes. ICCVAM also 
recommended the Cytosensor Microphysiometer (CM) test method as a 
screening test (1) to identify some types of substances that will not 
cause sufficient injury to require eye hazard labeling and (2) to 
identify some types of substances that may cause permanent or severe 
eye injuries. ICCVAM previously forwarded recommendations to Federal 
agencies and made these recommendations available to the public (75 FR 
57027). In accordance with the ICCVAM Authorization Act of 2000 (42 
U.S.C. 285l-3), agencies have notified ICCVAM in writing of their 
findings and ICCVAM is making these responses available to the public. 
Federal agency responses are available on the NICEATM-ICCVAM Web site 
at https://iccvam.niehs.nih.gov/methods/ocutox/Transmit-2010.htm. The 
ICCVAM recommendations are provided in ICCVAM test method evaluation 
reports that are available on the NICEATM-ICCVAM Web site at https://iccvam.niehs.nih.gov/methods/ocutox/OcuAnest-TMER.htm, https://iccvam.niehs.nih.gov/methods/ocutox/MildMod-TMER.htm, https://iccvam.niehs.nih.gov/methods/ocutox/AMCP-TMER.htm, and https://iccvam.niehs.nih.gov/methods/ocutox/LVET.htm.

FOR FURTHER INFORMATION CONTACT: Dr. William S. Stokes, Director, 
NICEATM, NIEHS, P.O. Box 12233, Mail Stop: K2-16, Research Triangle 
Park, NC 27709, (telephone) 919-541-2384, (fax) 919-541-0947, (e-mail) 
niceatm@niehs.nih.gov. Courier address: NICEATM, NIEHS, Room 2034, 530 
Davis Drive, Morrisville, NC 27560.

SUPPLEMENTARY INFORMATION: 

Background

    The U.S. Environmental Protection Agency (EPA) requested that 
ICCVAM (1) evaluate the current validation status of the bovine corneal 
opacity and permeability (BCOP), hen's egg test-chorioallantoic 
membrane (HET-CAM), isolated chicken eye (ICE), and isolated rabbit eye 
(IRE) test methods; (2) identify in vivo ocular toxicity reference data 
to support the validation of in vitro test methods; (3) explore ways of 
alleviating pain and distress from current in vivo ocular safety 
testing; and (4) review the state of the science and the availability 
of in vitro test methods for assessing mild or moderate ocular 
irritants. The highest priority activity, an evaluation of the BCOP, 
HET-CAM, ICE, and IRE test methods for their usefulness and limitations 
for identifying potential ocular corrosives and severe irritants, was 
completed in 2006 (NIH Publication No. 07-4517). Based on this 
evaluation, U.S. Federal agencies subsequently accepted the BCOP and 
ICE test methods for certain regulatory testing purposes without the 
need for animal testing. The Organisation for Economic Co-operation and 
Development (OECD) subsequently adopted the BCOP and ICE test methods 
in 2009 as international OECD Test Guidelines 437 and 438, respectively 
(OECD 2009a, OECD 2009b). The International Organization for 
Standardization (ISO) adopted the BCOP and ICE test methods as ISO 
Standard 10993-10 in 2010 (ISO 2010).
    ICCVAM recently completed additional test method evaluations 
relevant to the original EPA nomination and a subsequent EPA request 
that ICCVAM evaluate a proposed in vitro testing strategy for 
identifying the ocular hazard potential of antimicrobial cleaning 
products. Information is provided about ICCVAM's evaluation and the 
committee's recommendations for the alternative testing methods and 
strategies proposed to further reduce and refine the use of animals for 
assessing the ocular hazard potential of chemicals and products in four 
ICCVAM Test Method Evaluation Reports: (1) Recommendations for Routine 
Use of Topical Anesthetics, Systemic Analgesics, and Humane Endpoints 
to Avoid or Minimize Pain and Distress in Ocular Safety Testing (NIH 
Publication No. 10-7514), (2) Current Validation Status of In Vitro 
Test Methods Proposed for Identifying Eye Injury Hazard Potential of 
Chemicals and Products (NIH Publication No. 10-7553), (3) Current 
Validation Status of a Proposed In Vitro Testing Strategy for U.S. 
Environmental Protection Agency Ocular Hazard Classification and 
Labeling of Antimicrobial Cleaning Products (NIH Publication No. 10-
7513), and (4) Recommendation to Discontinue Use of the Low Volume Eye 
Test for Ocular Safety Testing (NIH Publication No. 10-7515).

Agency Responses to ICCVAM Recommendations

    In September 2010, ICCVAM forwarded final test method 
recommendations for ocular safety testing methods and strategies to 
U.S. Federal agencies for consideration, in accordance with the ICCVAM 
Authorization Act of 2000 (42 U.S.C.

[[Page 20673]]

285l-3) (75 FR 57027). The ICCVAM Authorization Act requires member 
agencies to review ICCVAM test method recommendations and notify ICCVAM 
in writing of their findings no later than 180 days after receipt of 
recommendations. The Act also requires ICCVAM to make ICCVAM 
recommendations and agency responses available to the public. Agency 
responses should include identification of relevant test methods for 
which the ICCVAM test method recommendations may be added or 
substituted and indicate any revisions or planned revisions to existing 
guidelines, guidances, or regulations to be made in response to these 
recommendations.
    ICCVAM agencies concurred with the test method recommendations for 
the in vitro ocular safety testing methods and strategies and support 
the routine use of topical anesthetics, systemic analgesics, and humane 
endpoints for ocular safety testing. Several agencies also indicated 
that they would communicate the ICCVAM recommendations to stakeholders 
and encourage their appropriate use. Agency responses are available at 
https://iccvam.niehs.nih.gov/methods/ocutox/Transmit-2010.htm.

Background Information on ICCVAM and NICEATM

    ICCVAM is an interagency committee composed of representatives from 
15 Federal regulatory and research agencies that require, use, 
generate, or disseminate toxicological and safety testing information. 
ICCVAM conducts technical evaluations of new, revised, and alternative 
safety testing methods with regulatory applicability and promotes the 
scientific validation and regulatory acceptance of toxicological and 
safety testing methods that more accurately assess the safety and 
hazards of chemicals and products and that reduce, refine (decrease or 
eliminate pain and distress), or replace animal use. The ICCVAM 
Authorization Act of 2000 (42 U.S.C. 285l-3) established ICCVAM as a 
permanent interagency committee of the NIEHS under NICEATM. NICEATM 
administers ICCVAM, provides scientific and operational support for 
ICCVAM-related activities, and conducts independent validation studies 
to assess the usefulness and limitations of new, revised, and 
alternative test methods and strategies. NICEATM and ICCVAM work 
collaboratively to evaluate new and improved test methods and 
strategies applicable to the needs of U.S. Federal agencies. NICEATM 
and ICCVAM welcome the public nomination of new, revised, and 
alternative test methods and strategies for validation studies and 
technical evaluations. Additional information about ICCVAM and NICEATM 
can be found on the NICEATM-ICCVAM Web site (https://iccvam.niehs.nih.gov).

References

ICCVAM. 2006. ICCVAM Test Method Evaluation Report: In Vitro Ocular 
Toxicity Test Methods for Identifying Severe Irritants and 
Corrosives. NIH Publication No. 07- 4517. Research Triangle Park, 
NC: NIEHS. Available: https://iccvam.niehs.nih.gov/methods/ocutox/ivocutox/ocu_tmer.htm.
ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Recommendations 
for Routine Use of Topical Anesthetics, Systemic Analgesics, and 
Humane Endpoints to Avoid or Minimize Pain and Distress in Ocular 
Safety Testing. NIH Publication No. 10-7514. Research Triangle Park, 
NC: NIEHS. Available: https://iccvam.niehs.nih.gov/methods/ocutox/OcuAnest-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Current 
Validation Status of In Vitro Test Methods Proposed for Identifying 
Eye Injury Hazard Potential of Chemicals and Products. NIH 
Publication No. 10-7553. Research Triangle Park, NC: NIEHS. 
Available: https://iccvam.niehs.nih.gov/methods/ocutox/MildMod-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Current 
Validation Status of a Proposed In Vitro Testing Strategy for U.S. 
Environmental Protection Agency Ocular Hazard Classification and 
Labeling of Antimicrobial Cleaning Products. NIH Publication No. 10- 
7513. Research Triangle Park, NC: NIEHS. Available: https://iccvam.niehs.nih.gov/methods/ocutox/AMCP-TMER.htm.
ICCVAM. 2010. ICCVAM Test Method Evaluation Report: Recommendation 
to Discontinue Use of The Low Volume Eye Test for Ocular Safety 
Testing. NIH Publication No. 10-7515. Research Triangle Park, NC: 
NIEHS. Available: https://iccvam.niehs.nih.gov/methods/ocutox/LVET.htm.
ISO. 2010. Biological evaluation of medical devices--10993 Part 10: 
Tests for irritation and skin sensitization. Available for purchase 
at: https://www.iso.org/iso/home.htm.
OECD. 2009a. Test Guideline 437. Bovine Corneal Opacity and 
Permeability Test Method for Identifying Ocular Corrosives and 
Severe Irritants, adopted September 2009. In: OECD Guidelines for 
Testing of Chemicals. Paris: OECD. Available: https://www.oecd-ilibrary.org/environment/test-no-437-bovine-corneal-opacity-and-permeability-test-method-for-identifying-ocular-corrosives-and-severe-irritants_9789264076303-en.
OECD. 2009b. Test Guideline 438. Isolated Chicken Eye Test Method 
for Identifying Ocular Corrosives and Severe Irritants, adopted 
September 2009. In: OECD Guidelines for Testing of Chemicals. Paris: 
OECD. Available: https://www.oecd-ilibrary.org/environment/test-no-438-isolated-chicken-eye-test-method-for-identifying-ocular-corrosives-and-severe-irritants_9789264076310-en.

    Dated: April 1, 2011.
John R. Bucher,
Associate Director, National Toxicology Program.
[FR Doc. 2011-8938 Filed 4-12-11; 8:45 am]
BILLING CODE 4140-01-P
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