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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 ReviewOpen for Public Comments or by using the search function and entering either the title of the information collection or the OMB
Control Number 06510035.
Further information can be obtained by:
Email: InformationCollection@
uspto.gov. Include 06510035
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
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Kimberly Hardy, Information Collections Officer, Office of the Chief Administrative Officer, United States Patent and Trademark Office.
FR Doc. 202106578 Filed 33021; 8:45 am BILLING CODE 351016P

CONSUMER PRODUCT SAFETY
COMMISSION
Docket No. CPSC20210006

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. CPSC2021
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

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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 5047479;
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, CPSC20210006, into the Search box, and follow the prompts. The proposed guidance is available under Supporting and Related Material. It is also available on the Commissions website at: https
cpsc.gov/s3fs-public/NOA-ProposedGuidance-on-Alternative-Test-Methodsand-Integrated-Testing-Approaches.pdf ?NDYVpNRIAMpOPJDPzlt770dvx nvPJHh6 and from the Commissions 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
9872025; email: jgordon@cpsc.gov.
SUPPLEMENTARY INFORMATION:
A. Background The Federal Hazardous Substances Act FHSA, 15 U.S.C. 12611275, 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
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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 ICCVAMs 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.
CPSCs 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/.

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