Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 493 

(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 study’s 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. 

§ 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 study’s 

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. 

[FR Doc. 2020–29179 Filed 1–5–21; 8:45 am] 

BILLING CODE 6560–50–P 

AGENCY FOR INTERNATIONAL 

DEVELOPMENT 

48 CFR Chapter 7 

RIN 0412–AA86 

Leave and Holidays for U.S. Personal 

Services Contractors, including Family 

and Medical Leave; Corrections 

AGENCY: Agency for International 

Development. 

ACTION: Correcting amendments; final 

rule. 

SUMMARY: 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 202–916–2629, or 

email at rspencer@usaid.gov. All 

communications regarding this rule 

must cite AIDAR RIN No. 0412–AA86. 

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 (a)(3) 

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 (a)(3) 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 


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494 Federal Register / Vol. 86, No. 3 / Wednesday, January 6, 2021 / Rules and Regulations 

the one authority citation that already 

exists. This document does not make 

any substantive changes to the final 

rule. 

List of Subjects in 48 CFR Chapter 7, 

Appendix D 

Government procurement. 

Accordingly, 48 CFR chapter 7 is 

corrected by making the following 

amendments: 

CHAPTER 7— AGENCY FOR 

INTERNATIONAL DEVELOPMENT 

■ 1. Amend appendix D to chapter 7 by: 

■ a. In section 12: 

■ i. In clause 5, by revising the clause 

heading, the last sentence in paragraph 

(a)(3) introductory text, paragraphs 

(a)(3)(i) and (ii); and 

■ ii. In clauses 6 and 16, revising the 

clause headings; and 

■ b. Revising the parenthetical authority 

citation at the end of the appendix. 

The revisions read as follows: 

Appendix D to Chapter 7—Direct 

USAID Contracts with a U.S. Citizen or 

a U.S. Resident Alien for Personal 

Services Abroad 

* * * * * 

12. General Provisions for a Contract With a 

U.S. Citizen or a U.S. Resident Alien for 

Personal Services Abroad 

* * * * * 

5. Leave and Holidays 

[Insert the following clause in all USPSC 

contracts.] 

Leave and Holidays (NOV 2020) 

(a) * * * 

(3) * * * Annual leave restored must be 

scheduled and used no later than the earlier 

of either— 

(i) The end of the leave year two years after 

the date fixed by the approving official as the 

termination date of the exceptional 

circumstances beyond the contractor’s 

control, which resulted in the forfeiture; or 

(ii) The end of the contract. 

* * * * * 

6. Differentials and Allowances (NOV 2020) 

* * * * * 

16. Termination (NOV 2020) 

* * * * * 

(Authority: Sec. 621 of Pub. L. 87–195, 75 

Stat. 445, (22 U.S.C. 2381) as amended; E.O. 

12163, Sept. 29, 1979, 44 FR 56673; and 3 

CFR 1979 Comp., p. 435) 

Mark A. Walther, 

Chief Acquisition Officer. 

[FR Doc. 2020–28047 Filed 1–5–21; 8:45 am] 

BILLING CODE 6116–01–P 


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