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Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 8 The extent to which the study minimizes the use of defaults and assumptions, uses appropriate and strong statistical methods, and includes a robust representation of uncertainty and confidence intervals; and 9 The studys consideration of a broad range of parametric dose-response or concentration-response models, a robust set of potential confounding variables, nonparametric models that incorporate fewer assumptions, various threshold models across the dose or exposure range, and models that investigate factors that might account for spatial heterogeneity.
e The EPA shall also describe critical assumptions and methods used in its dose-response assessment and shall characterize the variability and uncertainty of the assessment. The EPA
shall evaluate the appropriateness of using default assumptions on a case-bycase basis. The EPA shall clearly explain the scientific basis for critical assumptions used in the dose-response assessment that the EPA relied on for the significant regulatory action or influential scientific information.
f Where the Agency is making doseresponse data publicly available, it shall do so in a fashion that is consistent with law, protects privacy, confidentiality, confidential business information, and is sensitive to national security. Doseresponse data is considered publicly available in a manner sufficient for independent validation when it includes the information necessary for the public to understand, assess, and reanalyze findings and may include, for example:
1 Data data would be made available subject to access and use restrictions;
2 Associated protocols necessary to understand, assess, and extend conclusions;
3 Computer codes and models involved in the creation and analysis of such information;
4 Recorded factual materials; and 5 Detailed descriptions of how to access and use such information.
g The provisions of this section apply to dose-response data underlying studies that are pivotal science, regardless of who funded or conducted the studies. The Agency shall make all reasonable efforts to explore methodologies, technologies, and institutional arrangements for making such data available before it concludes that doing so in a manner consistent with law and protection of privacy, confidentiality, national security is not possible.

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30.6 What role does independent peer review have in this part?

The EPA shall conduct independent peer review consistent with the requirements of the OMB Final Information Quality Bulletin for Peer Review and the exemptions described therein. The EPA will evaluate whether or not to conduct additional peer review of individual studies identified as pivotal science if the studies have already undergone journal peer review.
Because transparency in pivotal science includes addressing issues associated with assumptions used in analyzing dose-response data, the EPA shall ask peer reviewers to articulate the strengths and weaknesses of the justification for the assumptions applied and the implications of those assumptions for the results.
30.7 May the EPA Administrator grant exemptions to this part?

a The Administrator may grant an exemption to this part for a study on a case-by-case basis if he or she determines that greater consideration is warranted because:
1 Technological or other barriers render sharing of the dose-response data infeasible;
2 The development of the doseresponse data was completed or updated before January 6, 2021;
3 Making the dose-response data available would conflict with laws and regulations governing privacy, confidentiality, confidential business information, or national security;
4 A third-party has conducted independent validation of the studys underlying dose-response data through reanalysis; or 5 The factors used in determining the consideration to afford to the pivotal science indicate full consideration is justified.
b When making a decision to grant an exemption, the Administrator may consider input from EPA staff and public commenters. The EPA shall document the rationale for exemptions granted by the Administrator in the significant regulatory action or influential scientific information.
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AGENCY FOR INTERNATIONAL
DEVELOPMENT
48 CFR Chapter 7
RIN 0412AA86

Leave and Holidays for U.S. Personal Services Contractors, including Family and Medical Leave; Corrections Agency for International Development.
ACTION: Correcting amendments; final rule.
AGENCY:

On October 16, 2020, the U.S.
Agency for International Development USAID issued a final rule revising provisions of the AID Acquisition Regulation AIDAR that pertain to the General Provision contract clause 5, entitled Leave and Holidays for U.S.
personal services contractors USPSCs.
This document corrects typographical errors in the final rule by revising the text of clause 5, adding the effective dates in the titles of clauses 6 and 16, and revising the authority citation.
DATES: Effective January 6, 2021.
FOR FURTHER INFORMATION CONTACT:
Richard E. Spencer, Procurement Analyst, by phone at 2029162629, or email at rspencer@usaid.gov. All communications regarding this rule must cite AIDAR RIN No. 0412AA86.
SUPPLEMENTARY INFORMATION: USAID is correcting errors in the final rule entitled Leave and Holidays for U.S.
Personal Services Contractors, including Family and Medical Leave, under AIDAR 48 CFR chapter 7, appendix D, which was published in the Federal Register on October 16, 2020 85 FR
65734. This document corrects the following typographical errors in AIDAR appendix D. In section 12 clause 5, the title is revised to remove italics, and the last sentence of paragraph a3
is revised because the final rule mistakenly included the word either twice, making the application of the sub-paragraphs i and ii illogical and impossible to apply. This document corrects the construction of this sentence in paragraph a3 to ensure only one of the two sub-paragraphs i or ii may apply, and by using the matching terminology for exceptional circumstances that appears earlier in the paragraph. In the titles for clauses 6, Differential and Allowances, and 16, Termination, the effective dates missing from the final rule are inserted for each clause. Lastly, the final rule mistakenly included an instruction to add a parenthetical authority citation at the end, unnecessarily creating a double citation. This document instead revises SUMMARY:

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