Title: Notice of Availability: Proposed Guidance on Alternative Test Methods and Integrated Testing Approaches, 16704-16705 [2021-06567]

Download as PDF 16704 Federal Register / Vol. 86, No. 60 / Wednesday, March 31, 2021 / Notices collection should be submitted within 30 days of the publication of this notice on the following website www.reginfo.gov/public/do/PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function and entering either the title of the information collection or the OMB Control Number 0651–0035. Further information can be obtained by: • Email: InformationCollection@ uspto.gov. Include ‘‘0651–0035 information request’’ in the subject line of the message. • Mail: Kimberly Hardy, Office of the Chief Administrative Officer, United States Patent and Trademark Office, P.O. Box 1450, Alexandria, VA 22313– 1450. Kimberly Hardy, Information Collections Officer, Office of the Chief Administrative Officer, United States Patent and Trademark Office. [FR Doc. 2021–06578 Filed 3–30–21; 8:45 am] BILLING CODE 3510–16–P CONSUMER PRODUCT SAFETY COMMISSION [Docket No. CPSC–2021–0006] Title: Notice of Availability: Proposed Guidance on Alternative Test Methods and Integrated Testing Approaches U.S. Consumer Product Safety Commission. ACTION: Notice of availability. AGENCY: The Consumer Product Safety Commission (Commission or CPSC) is announcing the availability of a document titled, ‘‘Proposed Guidance for Industry and Test Method Developers: CPSC Staff Evaluation of Alternative Test Methods and Integrated Testing Approaches and Data Generated from Such Methods to Support FHSA Labeling Requirements.’’ The Commission requests comments on the proposed guidance. DATES: Submit comments by June 14, 2021. SUMMARY: You may submit comments, identified by Docket No. CPSC–2021– 0006, by any of the following methods: Electronic Submissions: Submit electronic comments to the Federal eRulemaking Portal at: https:// www.regulations.gov. Follow the instructions for submitting comments. The CPSC does not accept comments submitted by electronic mail (email), except through https:// jbell on DSKJLSW7X2PROD with NOTICES ADDRESSES: VerDate Sep<11>2014 18:54 Mar 30, 2021 Jkt 253001 www.regulations.gov. The CPSC encourages you to submit electronic comments by using the Federal eRulemaking Portal, as described above. Mail/hand delivery/courier Written Submissions: Submit comments by mail/hand delivery/courier to: Division of the Secretariat, Consumer Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, MD 20814; telephone: (301) 504–7479; email: cpsc-os@cpsc.gov. Instructions: All submissions must include the agency name and docket number for this notice. CPSC may post all comments received without change, including any personal identifiers, contact information, or other personal information provided, to: https:// www.regulations.gov. Do not submit electronically: Confidential business information, trade secret information, or other sensitive or protected information that you do not want to be available to the public. If you wish to submit such information, please submit it according to the instructions for written submissions. Docket: For access to the docket to read background documents or comments received, go to: https:// www.regulations.gov, and insert the docket number, CPSC–2021–0006, into the ‘‘Search’’ box, and follow the prompts. The proposed guidance is available under ‘‘Supporting and Related Material.’’ It is also available on the Commission’s website at: https:// cpsc.gov/s3fs-public/NOA-ProposedGuidance-on-Alternative-Test-Methodsand-Integrated-Testing-Approaches.pdf ?NDYVpNRIAMpOPJDPzlt770dvx nvPJHh6 and from the Commission’s Division of the Secretariat. FOR FURTHER INFORMATION CONTACT: John Gordon, Toxicologist, Directorate for Health Sciences, U.S. Consumer Product Safety Commission, 5 Research Place, Rockville, MD 20850; telephone: 301– 987–2025; email: jgordon@cpsc.gov. SUPPLEMENTARY INFORMATION: A. Background The Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261–1275, requires that hazardous substances bear certain cautionary statements on their labels. Manufacturers may perform toxicological tests to determine whether such products require cautionary labeling addressing the hazard. Although animals are still used in toxicological testing, most governmental agencies support reduced use of animals in testing, by promoting the acceptance of data from alternative test methods. In 1997, the National Institute of Environmental Health Sciences PO 00000 Frm 00004 Fmt 4703 Sfmt 4703 (NIEHS), the National Toxicology Program (NTP), and 13 federal agencies (including CPSC) joined to form the Interagency Coordinating Committee for the Validation of Alternative Methods (ICCVAM). ICCVAM sponsors scientific review of non-animal tests (known as New Approach Methodologies or NAMs) that may reduce, refine, or replace animal tests in evaluating potential hazards. Reviews from ICCVAM and other federal agencies can provide a basis for regulatory agencies, such as CPSC, to consider non-animal testing alternatives for use in regulatory decision making. In the past, CPSC staff relied upon ICCVAM’s validation of new alternative testing methods, as reliable test methods to determine compliance with the labeling requirements of the FHSA. However, ICCVAM no longer formally validates test methods. In 2012, CPSC issued a policy on nonanimal or alternative testing methods to support labeling requirements under the FHSA, as codified under 16 CFR 1500.232 (Animal Testing Policy). CPSC’s website lists current CPSCaccepted alternative test methods and their conditions of use.1 Since 2012, new advancements in toxicological testing, and, in particular, with NAMs, have occurred. NAMs include in vitro (in test tube), in chemico (all chemical test, no biological material), or in silico (computer models) methods and approaches used to test for toxicological effects in place of animal testing. In some cases, NAMs are combined with other NAMs or existing in vivo (animal) data to form an ‘‘integrated approach to testing and assessment’’ (IATAs). The Commission reaffirms its policy to find alternatives to traditional animal testing that replace animals, reduce the number of animals tested, and decrease the pain and suffering in animals associated with testing household products. As such, the Commission strongly encourages all agency stakeholders to submit for evaluation by CPSC staff any scientifically validated alternative test methods that do not require animal testing for determining compliance with the labeling requirements under the FHSA. Because ICCVAM no longer formally validates test methods, to assist stakeholders, including the public, manufacturers, test method developers, and test laboratories, in determining what test methods are deemed reliable for determining compliance with the labeling requirements under the FHSA, 1 https://www.cpsc.gov/Business-Manufacturing/ Testing-Certification/Recommended-ProceduresRegarding-the-CPSCs-Policy-on-Animal-Testing/. E:\FR\FM\31MRN1.SGM 31MRN1 Federal Register / Vol. 86, No. 60 / Wednesday, March 31, 2021 / Notices jbell on DSKJLSW7X2PROD with NOTICES CPSC staff drafted proposed guidance clarifying staff’s informational requirements and process for evaluating NAMs and IATAs. As described in the proposed guidance, the types of information CPSC staff would use to evaluate NAMs or IATAs submitted to CPSC would include (but not be limited to): Concordance and reproducibility data; false positive and false negative rates; applicability domain; test endpoint; validation studies; or any other pertinent information needed to make a determination. The proposed guidance also includes an optional NAM nomination form, which can be used to organize information about a NAM or IATA for CPSC staff evaluation. Such non-animal alternative test methods, if accepted by CPSC, would be considered reliable test methods for determining compliance with the labeling requirements under the FHSA. Additionally, CPSC would continue to list CPSC-accepted alternative test methods on CPSC’s website. The proposed guidance is not a rule and does not establish legal requirements. The proposed guidance is intended to inform stakeholders about what information CPSC staff uses to evaluate NAMs or IATAs for FHSA labeling determinations. The proposed guidance also informs stakeholders of CPSC staff’s process for evaluating that information. Depending on the complexity of specific NAMs or IATAs, the information discussed in the guidance may or may not apply; and in some instances, staff may need additional information not specifically described in the guidance document to make an evaluation. The proposed guidance is available at: https:// www.regulations.gov under docket number, CPSC–2021–0006, under ‘‘Supporting and Related Material’’, on the Commission’s website at: https:// cpsc.gov/s3fs-public/NOA-ProposedGuidance-on-Alternative-Test-Methodsand-Integrated-Testing-Approaches.pdf ?NDYVpNRIAMpOPJDP zlt770dvxnvPJHh6, and from the CPSC’s Division of the Secretariat, as provided in the ADDRESSES section of this notice. B. Request for Comments The Commission invites comments on the ‘‘Proposed Guidance for Industry and Test Method Developers: CPSC Staff Evaluation of Alternative Test Methods and Integrated Testing Approaches and Data Generated from Such Methods to Support FHSA Labeling Requirements.’’ The CPSC will consider all timely comments before finalizing the guidance. Comments should be submitted by June 14, 2021. Information on how to submit comments can be VerDate Sep<11>2014 18:54 Mar 30, 2021 Jkt 253001 found in the ADDRESSES section of this notice. Alberta E. Mills, Secretary, Consumer Product Safety Commission. [FR Doc. 2021–06567 Filed 3–30–21; 8:45 am] BILLING CODE 6355–01–P CORPORATION FOR NATIONAL AND COMMUNITY SERVICE Agency Information Collection Activities; Submission to the Office of Management and Budget for Review and Approval; Comment Request; Application Package for AmeriCorps VISTA Application and Reporting Forms Corporation for National and Community Service. ACTION: Notice of information collection; request for comment. AGENCY: The Corporation for National and Community Service (operating as AmeriCorps) has submitted a public information collection request (ICR) entitled Application Package for AmeriCorps VISTA Application and Reporting Forms for review and approval in accordance with the Paperwork Reduction Act. DATES: Written comments must be submitted to the individual and office listed in the ADDRESSES section by April 30, 2021. ADDRESSES: Written comments and recommendations for the proposed information collection should be sent within 30 days of publication of this notice to www.reginfo.gov/public/do/ PRAMain. Find this particular information collection by selecting ‘‘Currently under 30-day Review—Open for Public Comments’’ or by using the search function. FOR FURTHER INFORMATION CONTACT: Copies of this ICR, with applicable supporting documentation, may be obtained by calling AmeriCorps, Kelly Daly at 202–606–6849 or by email to kdaly@cns.gov. SUPPLEMENTARY INFORMATION: The OMB is particularly interested in comments which: • Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of CNCS, including whether the information will have practical utility; • Evaluate the accuracy of the agency’s estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions; SUMMARY: PO 00000 Frm 00005 Fmt 4703 Sfmt 4703 16705 • Propose ways to enhance the quality, utility, and clarity of the information to be collected; and • Propose ways to minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. Comments A 60-day Notice requesting public comment was published in the Federal Register on November 30, 2020 at Vol. 85, No. 230, Page 76542. This comment period ended January 29, 2021. Zero public comments were received from this Notice. Title of Collection: Application Package for AmeriCorps VISTA Application and Reporting Forms. OMB Control Number: 3045–0038. Type of Review: Renewal. Respondents/Affected Public: Organizations and State, Local or Tribal Governments. Total Estimated Number of Annual Responses: 850. Total Estimated Number of Annual Burden Hours: 20,450. Abstract: AmeriCorps is revising its VISTA application and reporting forms to remove duplicative questions, improve readability, and reflect changes in reporting requirements, including a reduction in frequency of programmatic reporting. Dated: March 25, 2021. Margery Ansara, Director, AmeriCorps VISTA. [FR Doc. 2021–06574 Filed 3–30–21; 8:45 am] BILLING CODE 6050–28–P DEPARTMENT OF DEFENSE Defense Acquisition Regulations System Negotiation of a Renewal of the Reciprocal Defense Procurement Memorandum of Understanding with the Ministry of Defense of Japan Defense Acquisition Regulations System, Department of Defense (DoD). ACTION: Request for public comments. AGENCY: On behalf of the U.S. Government, DoD is contemplating a renewal of Reciprocal Defense Procurement Memorandum of Understanding with the Ministry of Defense of Japan. DoD is requesting industry feedback regarding its experience in public defense SUMMARY: E:\FR\FM\31MRN1.SGM 31MRN1

Agencies

[Federal Register Volume 86, Number 60 (Wednesday, March 31, 2021)]
[Notices]
[Pages 16704-16705]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06567]


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CONSUMER PRODUCT SAFETY COMMISSION

[Docket No. CPSC-2021-0006]


Title: Notice of Availability: Proposed Guidance on Alternative 
Test Methods and Integrated Testing Approaches

AGENCY: U.S. Consumer Product Safety Commission.

ACTION: Notice of availability.

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

SUMMARY: The Consumer Product Safety Commission (Commission or CPSC) is 
announcing the availability of a document titled, ``Proposed Guidance 
for Industry and Test Method Developers: CPSC Staff Evaluation of 
Alternative Test Methods and Integrated Testing Approaches and Data 
Generated from Such Methods to Support FHSA Labeling Requirements.'' 
The Commission requests comments on the proposed guidance.

DATES: Submit comments by June 14, 2021.

ADDRESSES: You may submit comments, identified by Docket No. CPSC-2021-
0006, by any of the following methods:
    Electronic Submissions: Submit electronic comments to the Federal 
eRulemaking Portal at: https://www.regulations.gov. Follow the 
instructions for submitting comments. The CPSC does not accept comments 
submitted by electronic mail (email), except through https://www.regulations.gov. The CPSC encourages you to submit electronic 
comments by using the Federal eRulemaking Portal, as described above.
    Mail/hand delivery/courier Written Submissions: Submit comments by 
mail/hand delivery/courier to: Division of the Secretariat, Consumer 
Product Safety Commission, Room 820, 4330 East West Highway, Bethesda, 
MD 20814; telephone: (301) 504-7479; email: [email protected].
    Instructions: All submissions must include the agency name and 
docket number for this notice. CPSC may post all comments received 
without change, including any personal identifiers, contact 
information, or other personal information provided, to: https://www.regulations.gov. Do not submit electronically: Confidential 
business information, trade secret information, or other sensitive or 
protected information that you do not want to be available to the 
public. If you wish to submit such information, please submit it 
according to the instructions for written submissions.
    Docket: For access to the docket to read background documents or 
comments received, go to: https://www.regulations.gov, and insert the 
docket number, CPSC-2021-0006, into the ``Search'' box, and follow the 
prompts. The proposed guidance is available under ``Supporting and 
Related Material.'' It is also available on the Commission's website 
at: https://cpsc.gov/s3fs-public/NOA-Proposed-Guidance-on-Alternative-Test-Methods-and-Integrated-Testing-Approaches.pdf?NDYVpNRIAMpOPJDPzlt770dvxnvPJHh6 and from the 
Commission's Division of the Secretariat.

FOR FURTHER INFORMATION CONTACT: John Gordon, Toxicologist, Directorate 
for Health Sciences, U.S. Consumer Product Safety Commission, 5 
Research Place, Rockville, MD 20850; telephone: 301-987-2025; email: 
[email protected].

SUPPLEMENTARY INFORMATION: 

A. Background

    The Federal Hazardous Substances Act (FHSA), 15 U.S.C. 1261-1275, 
requires that hazardous substances bear certain cautionary statements 
on their labels. Manufacturers may perform toxicological tests to 
determine whether such products require cautionary labeling addressing 
the hazard. Although animals are still used in toxicological testing, 
most governmental agencies support reduced use of animals in testing, 
by promoting the acceptance of data from alternative test methods.
    In 1997, the National Institute of Environmental Health Sciences 
(NIEHS), the National Toxicology Program (NTP), and 13 federal agencies 
(including CPSC) joined to form the Interagency Coordinating Committee 
for the Validation of Alternative Methods (ICCVAM). ICCVAM sponsors 
scientific review of non-animal tests (known as New Approach 
Methodologies or NAMs) that may reduce, refine, or replace animal tests 
in evaluating potential hazards. Reviews from ICCVAM and other federal 
agencies can provide a basis for regulatory agencies, such as CPSC, to 
consider non-animal testing alternatives for use in regulatory decision 
making. In the past, CPSC staff relied upon ICCVAM's validation of new 
alternative testing methods, as reliable test methods to determine 
compliance with the labeling requirements of the FHSA. However, ICCVAM 
no longer formally validates test methods.
    In 2012, CPSC issued a policy on non-animal or alternative testing 
methods to support labeling requirements under the FHSA, as codified 
under 16 CFR 1500.232 (Animal Testing Policy). CPSC's website lists 
current CPSC-accepted alternative test methods and their conditions of 
use.\1\ Since 2012, new advancements in toxicological testing, and, in 
particular, with NAMs, have occurred. NAMs include in vitro (in test 
tube), in chemico (all chemical test, no biological material), or in 
silico (computer models) methods and approaches used to test for 
toxicological effects in place of animal testing. In some cases, NAMs 
are combined with other NAMs or existing in vivo (animal) data to form 
an ``integrated approach to testing and assessment'' (IATAs).
---------------------------------------------------------------------------

    \1\ https://www.cpsc.gov/Business-Manufacturing/Testing-Certification/Recommended-Procedures-Regarding-the-CPSCs-Policy-on-Animal-Testing/.
---------------------------------------------------------------------------

    The Commission reaffirms its policy to find alternatives to 
traditional animal testing that replace animals, reduce the number of 
animals tested, and decrease the pain and suffering in animals 
associated with testing household products. As such, the Commission 
strongly encourages all agency stakeholders to submit for evaluation by 
CPSC staff any scientifically validated alternative test methods that 
do not require animal testing for determining compliance with the 
labeling requirements under the FHSA.
    Because ICCVAM no longer formally validates test methods, to assist 
stakeholders, including the public, manufacturers, test method 
developers, and test laboratories, in determining what test methods are 
deemed reliable for determining compliance with the labeling 
requirements under the FHSA,

[[Page 16705]]

CPSC staff drafted proposed guidance clarifying staff's informational 
requirements and process for evaluating NAMs and IATAs. As described in 
the proposed guidance, the types of information CPSC staff would use to 
evaluate NAMs or IATAs submitted to CPSC would include (but not be 
limited to): Concordance and reproducibility data; false positive and 
false negative rates; applicability domain; test endpoint; validation 
studies; or any other pertinent information needed to make a 
determination. The proposed guidance also includes an optional NAM 
nomination form, which can be used to organize information about a NAM 
or IATA for CPSC staff evaluation. Such non-animal alternative test 
methods, if accepted by CPSC, would be considered reliable test methods 
for determining compliance with the labeling requirements under the 
FHSA. Additionally, CPSC would continue to list CPSC-accepted 
alternative test methods on CPSC's website.
    The proposed guidance is not a rule and does not establish legal 
requirements. The proposed guidance is intended to inform stakeholders 
about what information CPSC staff uses to evaluate NAMs or IATAs for 
FHSA labeling determinations. The proposed guidance also informs 
stakeholders of CPSC staff's process for evaluating that information. 
Depending on the complexity of specific NAMs or IATAs, the information 
discussed in the guidance may or may not apply; and in some instances, 
staff may need additional information not specifically described in the 
guidance document to make an evaluation. The proposed guidance is 
available at: https://www.regulations.gov under docket number, CPSC-
2021-0006, under ``Supporting and Related Material'', on the 
Commission's website at: https://cpsc.gov/s3fs-public/NOA-Proposed-Guidance-on-Alternative-Test-Methods-and-Integrated-Testing-Approaches.pdf?NDYVpNRIAMpOPJDPzlt770dvxnvPJHh6, and from the CPSC's 
Division of the Secretariat, as provided in the ADDRESSES section of 
this notice.

B. Request for Comments

    The Commission invites comments on the ``Proposed Guidance for 
Industry and Test Method Developers: CPSC Staff Evaluation of 
Alternative Test Methods and Integrated Testing Approaches and Data 
Generated from Such Methods to Support FHSA Labeling Requirements.'' 
The CPSC will consider all timely comments before finalizing the 
guidance. Comments should be submitted by June 14, 2021. Information on 
how to submit comments can be found in the ADDRESSES section of this 
notice.

Alberta E. Mills,
Secretary, Consumer Product Safety Commission.
[FR Doc. 2021-06567 Filed 3-30-21; 8:45 am]
BILLING CODE 6355-01-P
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