[Federal Register Volume 86, Number 2 (Tuesday, January 5, 2021)]
[Rules and Regulations]
[Pages 250-254]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-26352]


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AGENCY FOR INTERNATIONAL DEVELOPMENT

22 CFR Part 212

RIN 0412-AB00


Procedures for the Review and Clearance of USAID's Guidance 
Documents

AGENCY: U.S. Agency for International Development (USAID).

ACTION: Final rule.

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SUMMARY: This final rule amends USAID's regulations to implement 
Executive Order (E.O.) 13891, Promoting the Rule of Law Through 
Improved Agency Guidance Documents. This rule sets forth processes and 
procedures for USAID to issue guidance documents as defined in the E.O. 
in a manner consistent with the requirements of Federal law applicable 
to all employees involved in inherently governmental deliberative 
decision-making on policy and employees involved in related 
administrative processes.

DATES: This final rule is effective January 5, 2021.

FOR FURTHER INFORMATION CONTACT: Tyrone K. Brown, Guidance Mailbox, 
(202) 355-7450, [email protected].

SUPPLEMENTARY INFORMATION:

Background

    On October 9, 2019 (84 FR 55235), President Trump issued Executive 
Order (E.O.) 13891, Promoting the Rule of Law Through Improved Agency 
Guidance Documents. The E.O. asserts that, except as mandated by 
applicable law or incorporated into a binding contract or agreement, 
Federal Departments and Agencies should treat guidance documents as 
non-binding on outside entities both in law and practice. To further 
the principle that Federal guidance should be transparent and made 
readily available to the public, Section 3 of the E.O. requires that 
Departments and Agencies make guidance documents available on a single, 
searchable, indexed public website. Section 3 also requires that 
Departments and Agencies review their guidance documents and, 
consistent with applicable law, rescind those that should no longer be 
in effect. Lastly, Section 4 requires that each Department and Agency 
put in place processes and procedures for issuing guidance documents as 
defined by the E.O.
    In accordance with that direction, to codify our processes and 
procedures for guidance documents, the U.S. Agency for International 
Development (USAID) is amending our Automated Directives System (ADS) 
to update ADS Chapter 501, which governs the clearance process for 
reviewing and issuing Agency policy documents, to include guidance 
documents as defined by the E.O. USAID's formal clearance process 
ensures that all guidance documents receive legal review and, when 
appropriate, review and approval from USAID's Regulatory Reform 
Officer, who is the Agency's Deputy Administrator.
    Before the Agency issues guidance documents as defined by E.O. 
13891, we must review them to ensure they are written in plain language 
and do not impose any substantive legal requirements above and beyond 
statute or regulation. If a guidance document purports to describe, 
approve, or recommend specific conduct not required by existing laws, 
statutes, and regulations, then it must include a clear and prominent 
statement that the contents of the guidance document do not have the 
force and effect of law and are not meant to bind the public in any 
way, and that the guidance document is intended only to provide clarity 
to the public regarding existing requirements under the law or internal 
Agency policies and procedures applicable to our staff.
    According to E.O. 13891, guidance documents shall also be subject 
to notice-and-comment procedures. The E.O. mandates that Departments 
and Agencies shall publish a notice in the Federal Register to announce 
that a draft of the proposed guidance document is publicly available; 
shall post the draft guidance document on the guidance portal of the 
Department or Agency; shall invite public comment on the draft document 
for a minimum of 30 days; and shall prepare and post a public response 
to major concerns raised in the comments, as appropriate, on its 
guidance portal, when the Department or Agency finalizes and issues the 
guidance document. Consistent with E.O. 13891, USAID proposes 
procedures to allow the public to petition for the modification or 
withdrawal of an active guidance document posted on the Agency's 
guidance portal. USAID's guidance portal will provide clear and 
specific instructions on how to request the modification or withdrawal 
of an active guidance document.
    The Office of the General Counsel (GC) at USAID has determined that 
the Agency has no ``guidance documents'' as defined under E.O. 13891. 
USAID's internal guidance materials do not qualify as ``guidance 
documents'' under the E.O., nor do grant and contract solicitations and 
awards; Country and Regional Development Cooperation Strategies; Agency 
programmatic Policies and Strategies; and purely internal Agency 
policies not intended to have substantial effect on the behavior of 
regulated parties, such as Chapters of our ADS. The procedures 
contained in this final rule apply to all guidance documents, which 
USAID defines as any statement of Agency policy or interpretation that 
concerns a statute, regulation, or technical matter within the 
jurisdiction of the Agency that is intended to have general 
applicability and future effect on the behavior of regulated parties, 
but which is not intended to have the force or effect of law in its own 
right and is not otherwise required by statute to satisfy the 
rulemaking procedures of the Administrative Procedure Act.

Notice and Comment Not Required

    This rule relates to internal Agency management. Therefore, 
pursuant to Section 553(a)(2) of Title 5 of the United States Code 
(U.S.C.), notice of proposed rulemaking and opportunity to comment are 
not required.

Procedural Requirements

    The Office of Management and Budget (OMB) has determined that this 
regulatory action does not meet the criteria for significant regulatory 
action

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pursuant to E.O. 12866, Regulatory Planning and Review. Additionally, 
because this rule does not meet the definition of a significant 
regulatory action, it does not trigger the requirements contained in 
E.O. 13771.
    The regulations added by this rule are intended to improve the 
internal management of USAID. As such, it is for the use of USAID 
personnel only and is not intended to, and does not, create any right 
or benefit, substantive or procedural, enforceable at law or in equity 
by any party against the United States, its Departments and Agencies or 
other entities, its officers or employees, or any other person. 
Accordingly, we expect the economic impact of this rule, if any, to be 
minimal.

Regulatory Flexibility Act

    Because notice-and-comment rulemaking is not necessary for this 
rule, the provisions of the Regulatory Flexibility Act, Section 604 of 
Title 5 of the U.S.C. do not apply.

Paperwork Reduction Act

    This final rule imposes no new reporting or recordkeeping 
requirements that necessitate clearance by OMB.

List of Subjects in 22 CFR Part 212

    Administrative practice, Freedom of Information Act (FOIA), 
Procedures.

    In consideration of the foregoing, and under the authority of E.O. 
13891, the U.S. Agency for International Development (USAID) amends 22 
CFR part 212 as follows:

0
1. The authority citation for part 22 continues to read as follows:


    Authority:  Pub. L. 114-185, 130 Stat. 538


0
2. Add subparts N and O, consisting of Sec.  212.25 through 212.40, to 
read as follows:
Sec.
Subpart N--Rulemaking
212.25. Responsibilities.
Subpart O--Procedures for Guidance Documents
212.26. General.
212.27. Review and clearance by the Office of the Bureau for 
Management.
212.28. Requirements for clearance.
212.29. Public access to effective guidance documents.
212.30. Good-faith cost estimates.
212.31. Approved procedures for guidance documents identified as 
``significant'' or ``otherwise of importance to the Agency's 
interests.''
212.32. Definitions of ``significant guidance document'' and 
guidance documents that are ``otherwise of importance to the 
Agency's interests.''
212.33. Designation procedures.
212.34. Notice-and-comment procedures.
212.35. Petitions for guidance.
212.36. Rescinded guidance.
212.37. Exigent circumstances.
212.38. Reports to Congress and the Government Accountability 
Office.
212.39. No judicial review or enforceable rights.
212.40. Use of guidance documents.

Subpart N--Rulemaking


Sec.  212.25  Responsibilities.

    (a) The Deputy Administrator serves as USAID's Regulatory Reform 
Officer (RRO). The RRO oversees implementation of regulatory-reform 
initiatives and policies to ensure USAID effectively manages regulatory 
burdens, consistent with applicable law.
    (b) The Assistant Administrator for Management serves as USAID's 
Regulatory Policy Officer (RPO) and provides oversight for the Agency's 
internal rulemaking process. The RPO must be involved in each stage of 
the regulatory process to foster the development of effective, 
innovative, and least-burdensome regulations.
    (c) The Office of Management Policy, Budget, and Performance in the 
Bureau for Management (M) coordinates the rulemaking process and 
ensures the Agency's rulemaking activities comply with all statutory 
and regulatory requirements.
    (d) The Initiating Program Office (IPO) at USAID is the Bureau or 
Independent Office (B/IO) that provides subject-matter expertise on 
regulatory matters that affect the IPO's programs.
    (e) The Office of the General Counsel at USAID provides guidance on 
legal and procedural requirements during the Agency's rulemaking 
process.

Subpart O--Guidance Procedures


Sec.  212.26  General.

    (a) This subpart governs all employees of the United States Agency 
for International Development (USAID) involved in any phase of issuing 
Agency guidance documents as defined by under E.O. 13891.
    (b) This subpart applies to all guidance documents issued by all 
components of the Agency after January 5, 2021.
    (c) For purposes of this subpart, the term ``guidance document'' 
includes any statement of Agency policy or interpretation that concerns 
a statute, regulation, or technical matter within the jurisdiction of 
the Agency that is intended to have general applicability and future 
effect, but is not intended to have the force or effect of law in its 
own right and is not otherwise required by statute to be implemented 
through the rulemaking procedures specified in 5 U.S.C. 553. The term 
is not confined to formal written documents; guidance may come in a 
variety of forms, including (but not limited to) letters, memoranda, 
circulars, bulletins, and advisories, and may include video, audio, and 
web-based formats. See OMB Bulletin 07-02, Agency Good Guidance 
Practices.
    (d) This subpart does not apply to the following:
    (1) Rules exempt from rulemaking requirements under 5 U.S.C. 
553(a);
    (2) Rules of Agency organization, procedure, or practice;
    (3) Decisions of Agency adjudications under 5 U.S.C. 554 or similar 
statutory provisions;
    (4) Internal executive management legal advice or legal advisory 
opinions addressed to executive officials;
    (5) Agency statements of specific applicability, including advisory 
or legal opinions directed to particular parties about circumstance-
specific questions (e.g., case or investigatory letters responding to 
complaints, warning letters), notices regarding particular locations or 
facilities (e.g., guidance that pertains to the use, operation, or 
control of a U.S. Government facility or property), and correspondence 
with individual persons or entities (e.g., Congressional 
correspondence), except documents ostensibly directed to a particular 
party but designed to guide the conduct of the broader regulated 
public;
    (6) Legal briefs, other court filings, or positions taken in 
litigation or enforcement actions;
    (7) Agency statements that do not set forth a policy on a 
statutory, regulatory, or technical issue or an interpretation of a 
statute or regulation, including speeches and individual presentations, 
editorials, media interviews, press materials, or Congressional 
testimony that do not set forth for the first time a new regulatory 
policy;
    (8) Guidance pertaining to military or foreign-affairs functions;
    (9) Grant solicitations and awards;
    (10) Contract solicitations and awards; or
    (11) Purely internal Agency guidance policies, such as Chapters of 
the ADS directed solely to USAID's employees, or to other Federal 
Departments and Agencies not intended to have substantial future effect 
on the behavior of regulated parties; USAID's Country/Regional 
Development Cooperation Strategies; the Agency's programmatic Policies 
and Strategies; Acquisition and Assistance Policy Directives (AAPDs); 
Application Guidelines; COVID-19 Guidance; Food for Peace Information 
Bulletins (FFPIBs); Guidance and Tools

[[Page 252]]

for Global Food-Security Programs; Procurement Executive Bulletins 
(PEBs); Standard Provisions for the Protecting Life in Global Health 
Assistance (PLGHA) Policy; and documents in the USAID Policy Registry.
212.40.


Sec.  212.27   Review and clearance by the Office of Management Policy, 
Budget, and Performance in the Bureau for Management.

    All USAID guidance documents, as defined by E.O. 13891 and Sec.  
212.26, require review and clearance in accordance with this subpart. 
The Bureau for Management (M Bureau) must review and clear any guidance 
a Bureau or Independent Office within USAID proposes to issue.


Sec.  212.28   Requirements for clearance.

    USAID's review and clearance of guidance documents shall ensure 
that each one that a B/IO within the Agency proposes to issue satisfies 
the following requirements:
    (a) The guidance document complies with all relevant statutes and 
regulations (including any statutory deadlines for the Agency's 
action);
    (b) The guidance document identifies or includes the following:
    (1) The term ``guidance'' or its functional equivalent;
    (2) The issuing B/IO within the Agency;
    (3) A unique identifier, including, at a minimum, the date of 
issuance and title of the document and a Regulation Identifier Number 
(RIN), if applicable;
    (4) The activity or entities to which the guidance applies;
    (5) Citations to applicable statutes and regulations;
    (6) A statement that notes whether the guidance is intended to 
revise or replace any previously issued guidance and, if so, sufficient 
information to identify the previously issued guidance; and
    (7) A short summary at the top of the document of the subject 
matter covered in the guidance document.
    (c) The guidance document avoids using mandatory language, such as 
``shall,'' ``must,'' ``required,'' or ``requirement,'' unless the 
language is describing an established statutory or regulatory 
requirement, or is addressed to USAID's staff and will not foreclose 
the Agency's consideration of positions advanced by affected private 
parties; and
    (d) The guidance document is written in plain and understandable 
English. All guidance documents should include a clear and prominent 
statement to declare that the contents of the document do not have the 
force and effect of law and are not meant to bind the public in any 
way, and the document is intended only to provide clarity to the public 
regarding existing requirements under the law or USAID's policies.


Sec.  212.29   Public access to effective guidance documents.

    Each B/IO within USAID responsible for issuing guidance documents 
shall do the following:
    (a) Ensure all effective guidance documents, identified by a unique 
identifier that includes, at a minimum, the document's title and date 
of issuance or revision and its RIN, if applicable, are on USAID's 
guidance portal in a single, searchable, indexed database and are 
available to the public in accordance with 5 U.S.C. 552(a)(2);
    (b) Note on USAID's guidance portal that guidance documents lack 
the force and effect of law, except as authorized by law and are not 
meant to bind the public in anyway;
    (c) Maintain and advertise USAID's guidance portal as a means for 
the public to comment electronically on any guidance documents that are 
subject to the notice-and-comment procedures described in Sec.  212.34 
and to submit requests electronically for the issuance, 
reconsideration, modification, or rescission of guidance documents in 
accordance with Sec.  212.26; and
    (d) The Bureau for Management is the office designated to receive 
and address complaints from the public that USAID is not following the 
requirements of OMB's Good Guidance Bulletin, or is improperly treating 
a guidance document as a binding requirement.


Sec.  212.30   Good-faith cost estimates.

    Even though not legally binding, some Agency guidance could result 
in a substantial economic impact. For example, the issuance of Agency 
guidance could induce private parties to alter their conduct to conform 
to recommended standards or practices, such that they could incur costs 
beyond the costs of complying with existing statutes and regulations. 
While it might be difficult to predict with precision the economic 
impact of voluntary guidance, to the extent practicable the proposing 
B/IO within USAID shall make a good-faith effort to estimate the likely 
economic cost impact of the guidance document to determine whether it 
might qualify as ``significant.'' When a B/IO is assessing or 
explaining whether it believes a guidance document is significant, it 
should, at a minimum, provide the same level of analysis that would be 
required for a determination under the Congressional Review Act (M-19-
14), Guidance on Compliance with the Congressional Review Act, that the 
guidance document is major. When USAID determines that a guidance 
document will be ``economically significant,'' the proposing B/IO 
should conduct and publish a regulatory-impact analysis of the sort 
that would accompany an economically significant rulemaking, to the 
extent reasonably possible (in conformance with E.O. 12866).


Sec.  212.31   Approval procedures for guidance documents identified as 
``significant'' or ``otherwise of importance to the Agency's 
interests.''

    (a) For guidance a USAID B/IO proposes to issue, if there is a 
reasonable possibility a guidance document could be as ``significant'' 
or ``otherwise of importance to the Agency's interests'' within the 
meaning of Sec.  212.31, or if the B/IO is uncertain whether the 
guidance could qualify as such, the B/IO should email a copy of the 
proposed guidance document (or a summary of it) to the M Bureau for 
review and further direction before issuance.
    (b) As with significant regulations, after appropriate internal 
consultation and review, the M Bureau will submit significant guidance 
documents that are otherwise of importance to the Agency's interests to 
the Office of Information and Regulatory Affairs (OIRA) within OMB for 
review and designation.
    (c) If OMB/OIRA determines a guidance document from a USAID B/IO 
not to be either significant or otherwise of importance to the Agency's 
interests within the meaning of Sec.  212.31, the Bureau for Management 
may proceed with issuance. For each guidance document coordinated 
through the Office of the Administrator, the issuing B/IO should 
include a statement in the Action Memorandum to indicate that the OMB/
OIRA has reviewed and cleared the guidance document in accordance with 
this process.


Sec.  212.32   Definitions of ``significant guidance document'' and 
guidance documents that are ``otherwise of importance to the Agency's 
interests.''

    (a) The term ``significant guidance document'' means a guidance 
document USAID will disseminate to regulated entities or the general 
public and that might reasonably be anticipated:
    (1) To lead to an annual effect on the U.S. economy of $100 million 
or more, or adversely affect in a material way the U.S. economy, a 
sector of the U.S. economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities;

[[Page 253]]

    (2) To create serious inconsistency or otherwise interfere with an 
action taken or planned by another Federal Department or Agency;
    (3) To alter materially the budgetary impact of entitlements, 
grants, user fees, or loan programs or the rights and obligations of 
recipients thereof; or
    (4) To raise novel legal or policy issues that arise out of legal 
mandates, the President's priorities, or the principles set forth in 
E.O. 12866, as further amended.
    (b) The term ``significant guidance document'' does not include the 
categories of documents excluded by Sec.  212.26 or any other category 
of guidance documents exempted in writing by OMB/OIRA.
    (c) OMB/OIRA must review significant and economically significant 
guidance documents under E.O. 12866 before issuance, and they must 
demonstrate compliance with the applicable requirements for regulations 
or rules, including significant regulatory actions, set forth in E.O. 
12866, E.O. 13563, E.O. 13609, E.O. 13771, and E.O. 13777.
    (d) Even if not ``significant,'' USAID will consider a guidance 
document of regulatory impact as ``otherwise of importance to the 
Agency's interests'' within the meaning of this paragraph if it might 
reasonably be anticipated:
    (1) To relate to a major program, policy, or activity of the Agency 
or a high-profile issue that is pending for decision before the Agency;
    (2) To involve one of the Administrator's top policy priorities;
    (3) To garner significant press or Congressional attention; or
    (4) To raise significant questions or concerns from constituencies 
of importance to the Agency, such as Committees of Congress, States or 
Indian tribes, the White House or other Departments and Agencies of the 
Executive Branch, courts, consumer or public-interest groups, or 
leading representatives of industry.
    (e) As noted in paragraphs (a) through (d) of this section, 
``guidance documents'' for the purposes of this rule, including this 
subpart, do not include those documents identified in this subpart O.


Sec.  212.33   Designation procedures.

    (a) The Bureau for Management may request a B/IO within USAID to 
prepare a designation request for certain guidance documents. 
Designation requests must include the following information:
    (1) A summary of the guidance document; and
    (2) The B/IO's recommended designation of ``not significant,'' 
``significant,'' or ``economically significant,'' as well as a 
justification for that designation.
    (b) Except as otherwise provided in paragraph (c) of this section, 
the Agency will seek significance determinations from OMB/OIRA for 
certain guidance documents, as appropriate, in the same manner as for 
rulemakings. Prior to publishing these guidance documents, after 
internal consultation and review, the Bureau for Management shall 
submit the document to OMB/OIRA for review under the provisions in 
Section 6 of E.O. 12866 to determine if it meets the definition of 
``significant'' or ``economically significant.''
    (c) All ``guidance documents'' as with rulemakings, receive a 
significance determination from OMB/OIRA, unless explicitly exempt from 
E.O. 12866. Note that the only documents that do not receive 
designations are those that fall outside the definition of ``guidance'' 
or within a group categorically considered nonsignificant as agreed 
upon by OMB/OIRA in Memorandum M-20-02).


Sec.  212.34   Notice-and-comment procedures.

    (a) Except as provided in paragraph (b) of this section, all 
proposed USAID guidance documents determined to be a ``significant 
guidance document'' within the meaning of Sec.  212.31 shall be subject 
to the following notice-and-comment procedures:
    (1) The issuing B/IO within USAID shall publish a notice in the 
Federal Register to announce that a draft of the proposed guidance 
document is publicly available; post the draft guidance document on the 
Agency's guidance portal; invite public comment on the draft document 
for a minimum of 30 days; and
    (2) Prepare and post a public response to major concerns raised in 
the comments, as appropriate, on USAID's guidance portal, when the 
Agency finalizes and issues the guidance document.
    (b) The requirements of paragraph (a) of this section will not 
apply to any significant guidance document or categories of significant 
guidance documents for which the Bureau for Management finds, in 
consultation with GC, the proposing B/IO, and USAID's RRO, good cause 
that notice and public procedure thereon are impracticable, 
unnecessary, or contrary to the public interest (and incorporates the 
finding of good cause and a brief statement of reasons therefore in the 
guidance issued).
    (c) Where appropriate, the Bureau for Management and the proposing 
B/IO may recommend to the RRO that a particular guidance document that 
is otherwise of importance to the Agency's interests shall also be 
subject to the notice-and-comment procedures described in paragraph (a) 
of this section.


Sec.  212.35   Petitions for guidance.

    Any person may petition the Agency to withdraw or modify a 
particular guidance document by using the procedures found in Sec.  
212.26(c). USAID should respond to all requests in a timely manner, but 
no later than 90 days after receipt of the request.


Sec.  212.36   Rescinded guidance.

    No B/IO within USAID may cite, use, or rely on guidance documents 
that are rescinded, except to establish historical facts.


Sec.  212.37   Exigent circumstances.

    In emergency situations, or when a statutory deadline or court 
order requires the issuing B/IO within USAID to act more quickly than 
normal review procedures allow, the issuing B/IO shall coordinate with 
the Bureau for Management to notify OMB/OIRA as soon as possible and, 
to the extent practicable, shall comply with the requirements of this 
subpart at the earliest opportunity. Wherever practicable, the issuing 
B/IO should schedule its proceedings to permit sufficient time to 
comply with the procedures set forth in this subpart.


Sec.  212.38   Reports to Congress and the Government Accountability 
Office.

    Unless otherwise determined in writing, it is the policy of USAID 
that upon issuing a guidance document determined to be ``significant'' 
within the meaning of Sec.  212.31 the issuing B/IO shall submit a 
report to Congress and the Government Accountability Office in 
accordance with the procedures described in 5 U.S.C. 801 (the 
Congressional Review Act [CRA]). Under the CRA, USAID must coordinate 
with OMB/OIRA regarding a major determination for all guidance 
documents, irrespective of whether the Agency otherwise would submit a 
rule for regulatory review (Memorandum-19-14).


Sec.  212.39   No judicial review or enforceable rights.

    This subpart is intended to improve the internal management of 
USAID. As such, it is for USAID personnel only and is not intended to, 
and does not, create any right or benefit, substantive or procedural, 
enforceable at law or in equity by any party against the United States, 
its Departments and Agencies or other entities, its officers or 
employees, or any other person.

[[Page 254]]

Sec.  212.40   Use of guidance documents.

    Guidance documents cannot create binding requirements that do not 
already exist by statute or regulation. Accordingly, non-compliance 
with guidance documents cannot be used as a basis for proving 
violations of applicable law. Guidance documents can do no more, with 
respect to prohibition of conduct, than articulate USAID's 
understanding of how a statute or regulation applies to particular 
circumstances.

Ruth Buckley,
Acting Performance Improvement Officer/Acting Office Director, Bureau 
for Management Office of Management Policy, Budget and Operational 
Performance.
[FR Doc. 2020-26352 Filed 1-4-21; 8:45 am]
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