Department of Health and Human Services Good Guidance Practices, 51396-51401 [2020-18208]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 85, Number 162 (Thursday, August 20, 2020)]
[Proposed Rules]
[Pages 51396-51401]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18208]



[[Page 51396]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

45 CFR Part 1

RIN 0991-AC17


Department of Health and Human Services Good Guidance Practices

AGENCY: Office of the Secretary, Department of Health and Human 
Services.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Department of Health and Human Services proposes to issue 
regulations governing the agency's release and maintenance of guidance 
documents. These regulations would help to ensure that the public 
receives appropriate notice of new guidance and that the Department's 
guidance does not impose obligations on regulated parties that are not 
already reflected in duly enacted statutes or regulations lawfully 
promulgated under them.

DATES: To be assured consideration, comments must be received at one of 
the addresses provided below, no later than 11:59 p.m. on September 16, 
2020.

ADDRESSES: Because of staff and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission.
    Comments, including mass comment submissions, must be submitted 
electronically at https://www.regulations.gov. Follow the ``Submit a 
comment'' instructions.
    For information on viewing public comments, see the beginning of 
the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Brenna Jenny, Department of Health and 
Human Services, 200 Independence, Avenue SW, Room 713F, Washington, DC 
20201. Email: [email protected]. Telephone: (202) 690-7741.

SUPPLEMENTARY INFORMATION: 
    Inspection of Public Comments: All comments received before the 
close of the comment period are available for viewing by the public, 
including any personally identifiable or confidential business 
information that is included in a comment. Before or after the close of 
the comment period, the Department of Health and Human Services will 
post all timely submitted comments on https://www.regulations.gov. 
Follow the search instructions on that website to view public comments.

I. Statutory and Regulatory Background

    Subject to certain exceptions, the Administrative Procedure Act 
(``APA''), 5 U.S.C. 551 et seq., mandates that rules imposing new 
obligations on regulated parties must go through notice-and-comment 
rulemaking. See, e.g., Chrysler Corp. v. Brown, 441 U.S. 281, 302 
(1979). This is true regardless of whether agencies frame these rules 
as sub-regulatory guidance. See, e.g., Iowa League of Cities v. E.P.A., 
711 F.3d 844, 875 (8th Cir. 2013); Gen. Elec. Co. v. E.P.A., 290 F.3d 
377, 385 (D.C. Cir. 2002). The APA's procedural requirements sound in 
notions of good governance. See, e.g., Smiley v. Citibank, N.A., 517 
U.S. 735, 741 (1996). Agencies can generally issue interpretive rules 
and statements of policy without conducting notice-and-comment 
rulemaking,\1\ although such sub-regulatory guidance lacks the force 
and effect of law and cannot bind regulated parties. See, e.g., Shalala 
v. Guernsey Mem'l Hosp., 514 U.S. 87, 99 (1995).
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    \1\ But see Azar v. Allina Health Services, 139 S. Ct. 1804 
(2019).
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II. Summary of Proposed Good Guidance Practices Regulations

    To promote the appropriate issuance and use of guidance documents, 
and consistent with the requirements of Executive Order 13891 of 
October 9, 2019, ``Promoting the Rule of Law Through Improved Agency 
Guidance Documents,'' 84 FR 55235 (Oct. 15, 2019), the United States 
Department of Health and Human Services (``HHS'' or ``the Department'') 
is proposing to issue regulations that set forth good guidance 
practices that would apply to all divisions of HHS other than the Food 
and Drug Administration (``FDA''). FDA currently operates under a set 
of good guidance practices regulations, see 21 CFR 10.115, as required 
by the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 371(h), but no 
other division within HHS operates under a similar set of regulations. 
FDA will also be proposing amendments to its good guidance practices 
regulations, which would revise the requirements at 21 CFR 10.115 to 
incorporate the directives of Executive Order 13891. The requirements 
in this HHS proposed rule, if finalized, would be promulgated at 45 CFR 
part 1, which is currently unassigned.
    This proposed good guidance practices rule is one component of the 
Department's broader regulatory reform initiative. The proposed rule is 
designed to increase accountability, improve the fairness of guidance 
issued by the Department, guard against unlawful regulation through 
guidance, and safeguard the important principles underlying the United 
States administrative law system.

A. Scope (Sec.  1.1)

    HHS proposes that the requirements to be established pursuant to 
this proposed rule would apply to all guidance documents issued by all 
components of the Department, except for FDA, which has its own good 
guidance practices regulations that it is in the process of amending to 
conform, as appropriate, to the requirements of Executive Order 13891.

B. Definitions (Sec.  1.2)

Guidance Document
    This proposed rule, if finalized, would apply to guidance documents 
(including those deemed ``significant'') issued by the Department, 
other than guidance documents issued by FDA. HHS proposes to define 
``guidance document'' as any Department statement of general 
applicability which is intended to have future effect on the behavior 
of regulated parties and which sets forth a policy on a statutory, 
regulatory, or technical or scientific issue, or an interpretation of a 
statute or regulation. The contents of a transmission, rather than its 
format, dictates whether it would constitute a guidance document; 
guidance would not need to be in the form of a formal written document 
to constitute a ``guidance document'' under this proposed rule. Rather, 
guidance may come in a variety of forms, including, but not limited to, 
letters, memoranda, circulars, bulletins, advisories, and preambles and 
may include video, audio, and Web-based formats. See OMB Bulletin 07-
02, ``Agency Good Guidance Practices,'' 72 FR 3432, 3434 (January 25, 
2007). The hallmark of guidance is that it includes statements of 
general applicability intended to govern the future behavior of 
regulated parties. Thus, agency releases of technical or scientific 
information would not constitute guidance unless also accompanied by a 
policy on or related to that technical or scientific information that 
is intended to affect the future behavior of regulated parties. This 
proposed rule would not require HHS to justify the quality of 
information; regulated parties and other stakeholders should use 
existing mechanisms to address the quality of information contained in 
documents issued by HHS. Materials directed at government employees or 
agency contractors, rather than regulated parties would also not 
constitute guidance within the meaning of this proposed rule. 
Similarly, most agency statements communicating news updates about the 
agency would not constitute guidance. Agency statements of specific

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applicability--such as advisory or legal opinions directed to 
particular parties about circumstance-specific questions; notices 
regarding particular locations, facilities, or products; and 
correspondence with individual persons or entities, including 
congressional correspondence or notices of violation--would also not be 
``guidance.''
    Certain categories of documents would be excluded from the term 
guidance document under the proposed rule: Rules promulgated pursuant 
to notice and comment under 5 U.S.C. 553 or similar statutory 
provisions; rules exempt from rulemaking requirements under 5 U.S.C. 
553(a); rules of agency organization, procedure, or practice; decisions 
of agency adjudications under 5 U.S.C. 554 or similar statutory 
provisions; internal guidance directed to the Department or other 
agencies that is not intended to have substantial future effect on the 
behavior of regulated parties; internal executive branch legal advice 
or legal opinions addressed to executive branch officials; legal briefs 
and other court filings; grant solicitations and awards; or contract 
solicitations and awards.
    Whether a document would be exempt as a rule of agency 
organization, procedure, or practice is a functional test. Documents 
that are designed to shape the behavior of the Department would be 
exempt; documents designed to shape the behavior of regulated parties 
would be considered guidance if they also set forth a policy on a 
statutory, regulatory, or technical or scientific issue, or an 
interpretation of a statute or regulation.
    Pre-enforcement rulings, which are formal written communications 
applying the law to a specific set of facts (as opposed to making 
statements of general applicability) would also not constitute guidance 
documents under the proposed rule. Examples include letter rulings, 
advisory opinions, and no-action letters. But material embedded within 
an advisory opinion or similar letter that otherwise satisfies the 
definition of ``guidance document'' would still be guidance for 
purposes of this rule. If a document addressed to specific individuals 
nonetheless contains a statement of general applicability setting forth 
a relevant policy or interpretation that is intended to have future 
effect by guiding the conduct of other regulated parties, then the 
document would be a guidance document.
    Consistent with its existing responsibilities, the HHS Office of 
the General Counsel (``OGC''), after discussing with senior officials 
within the Department, would make the legal determination of whether a 
document is excluded from the term ``guidance document'' and whether a 
purported guidance document is, in fact, a legislative rule that must 
go through notice-and-comment rulemaking. OGC would continue to 
determine whether the contents of certain guidance relating to Medicare 
should nonetheless go through notice-and-comment rulemaking as a result 
of the Supreme Court's decision in Azar v. Allina Health Services, 139 
S. Ct. 1804 (2019). Such guidance documents would still need to meet 
all applicable requirements in this part.
Significant Guidance Document
    HHS proposes to define ``significant guidance document''; 
additional procedural requirements, as set forth below, would apply to 
a significant guidance document. HHS proposes to define the term as a 
guidance document that is likely to lead to an annual effect on the 
economy of $100 million or more, or adversely affect in a material way 
the economy, a sector of the economy, productivity, competition, jobs, 
the environment, public health or safety, or state, local, or tribal 
governments or communities; create a serious inconsistency or otherwise 
interfere with an action taken or planned by another agency; materially 
alter the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights or obligations of recipients thereof; or raise 
novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles of Executive Order 12866, 
``Regulatory Planning and Review.'' To calculate whether a guidance 
document is likely to have an annual effect on the economy of $100 
million or more, HHS would be required to assess the benefits, costs, 
or transfer impacts imposed by that guidance document; as part of this 
analysis, any benefit, cost or transfer occurring in any consecutive 
twelve-month period would be compared against the $100 million 
threshold. Future cost savings would not be used to offset upfront 
costs. In performing these analyses, HHS would recognize that guidance 
documents are not legally binding and, therefore, not all regulated 
parties would necessarily conform their behavior to the recommendations 
set forth in the guidance, and furthermore, that the benefits, costs, 
and transfers may have been accounted for when HHS issued an underlying 
regulation, if any.
    HHS operates from the principle that actions imposing significant 
benefits, costs, or transfer impacts on regulated parties must comply 
with heightened procedural requirements. However, it anticipates that 
only a subset of guidance documents would satisfy this proposed rule's 
definition of a significant guidance document. This is because to 
qualify as guidance, as opposed to a legislative rule, a document must 
reflect, implement, interpret, or describe a legal obligation imposed 
by a pre-existing, external source or advise the public prospectively 
of the manner in which the agency intends to exercise a discretionary 
power. It is HHS's presumption that a guidance document that HHS deems 
significant is actually a legislative rule that must go through notice-
and-comment rulemaking. HHS shall make all initial decisions as to 
whether a guidance document is significant, and OMB shall make all 
final determinations. If a significance determination requires a legal 
conclusion, OMB cannot reach legal conclusions on behalf of HHS.
Issued
    HHS proposes to define ``issued'' to mean distribution of 
information to the public that HHS initiated or sponsored. But if a 
document directed solely to Department employees must be made publicly 
available under law or agency disclosure policies, for example posted 
on an agency website as the result of multiple requests under the 
Freedom of Information Act, the document would not be considered to be 
issued under this proposed rule.
Guidance Repository
    HHS proposes to define ``guidance repository'' to mean an online 
electronic database containing or linking to guidance documents. It 
further proposes that the Department's primary guidance repository can 
link to subsidiary guidance repositories.

C. Requirements for Department Issuance and Use of Guidance Documents 
(Sec.  1.3)

    The proposed rule reiterates the application of existing legal 
principles to HHS's guidance: Unless otherwise authorized by statute, 
HHS may not issue any guidance document that establishes legal 
obligations not reflected in duly enacted statutes or regulations 
lawfully promulgated under them, and may not use any guidance document 
for purposes of requiring persons or entities outside HHS to take any 
action or to refrain from taking any action beyond what is already 
required by the terms of an applicable statute or regulation.
    The proposed rule would also create a process for issuing guidance 
that formalizes guardrails designed to ensure

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that guidance documents are appropriately issued and used. If the 
proposed rule is finalized, following the effective date, each guidance 
document issued by HHS, or any of its components, would be required 
specifically to state that it is a ``guidance'' document and use the 
following language, unless the guidance is authorized by law to be 
binding: ``The contents of this document do not have the force and 
effect of law and are not meant to bind the public in any way, unless 
specifically incorporated into a contract. This document is intended 
only to provide clarity to the public regarding existing requirements 
under the law.'' No guidance document issued by HHS would be able to 
direct parties outside the Federal government to take or refrain from 
taking action, except when restating--with citations to statutes, 
regulations, or binding judicial precedent--mandates contained in a 
statute or regulation.
    HHS proposes to require that each guidance document issued by it or 
any component after the effective date of this rule, if finalized, must 
also include the following information: (1) The activities to which and 
the persons to whom the guidance applies; (2) the date HHS issued the 
guidance document; (3) a unique agency identifier; (4) a statement 
indicating whether the guidance document replaces or revises a 
previously issued guidance document and, if so, identifying the 
guidance document that it replaces or revises; (5) a citation to the 
statutory provision(s) and/or regulation(s) (in Code of Federal 
Regulations format) that the guidance document is interpreting or 
applying; and (6) a short summary of the subject matter covered in the 
guidance document. For guidance documents issued before the 
implementation date of this rule, HHS would not retrospectively revise 
those guidance documents to include the information listed in this 
paragraph. Any guidance document issued in conjunction with one or more 
other agencies would nonetheless be required to comply with all 
requirements that would be applicable if the guidance document were 
issued solely by HHS.
    HHS is proposing to apply additional procedures to significant 
guidance documents. Under the proposed rule, HHS would submit all 
significant guidance documents to the Office of Information and 
Regulatory Affairs (OIRA) for review under Executive Order 12866 prior 
to issuance. Significant guidance documents would be required to comply 
with applicable requirements for significant regulatory actions, as set 
forth in executive orders, except that only economically significant 
guidance documents would require a separate Regulatory Impact Analysis. 
The Secretary, on a non-delegable basis, would have to approve any 
significant guidance document before the Department issues it.
    HHS also proposes that, prior to issuing any significant guidance 
document, HHS must also offer a public notice and comment period of at 
least 30 days. HHS would be required to publish a public notice in both 
the Federal Register and the guidance repository. This notice would 
list the end of the comment period, provide information about where the 
public may access a copy of the proposed significant guidance document, 
and include how written comments may be submitted on the proposed 
significant guidance document and an internet website where those 
comments may be reviewed by the public. When issuing the significant 
guidance document, HHS would be required to review all comments 
received and publish an easily accessible public response to major 
concerns raised. Cf., e.g., City of Portland, Oregon v. E.P.A., 507 
F.3d 706, 715 (DC Cir. 2007).
    Under the proposed rule, HHS could elect not to conduct a comment 
period if it were to find that notice and public comment are 
impracticable, unnecessary, or contrary to the public interest. The 
Secretary, as the individual approving the significant guidance 
document, would be required to make this finding, and the significant 
guidance document would have to incorporate the finding and a brief 
statement of reasons in support of such finding. In addition, a 
significant guidance document could be exempted from any other 
requirement otherwise applicable to significant guidance documents if 
the Secretary of HHS and the Administrator of OIRA were to agree that 
exigency, safety, health, or other compelling cause warrants the 
exemption.
    Also under the proposed rule, HHS would seek from OIRA, as 
appropriate, categorical determinations that classes of guidance 
presumptively do not qualify as significant. Any guidance satisfying 
such a categorical exemption presumptively need not comply with the 
requirements of Sec.  1.3(b), but would need to comply with all other 
requirements applicable to guidance documents. OIRA may request to 
review guidance documents within a categorical exemption and may 
nonetheless conclude that a guidance document that is presumptively not 
significant is in fact significant.
    HHS seeks comments on the proposed process for issuing guidance 
documents, as well as the proposed additional requirements for issuing 
significant guidance documents, including, for example, whether under 
this proposed rule the Secretary should have the limited authority to 
delegate approval of guidance documents to the Deputy Secretary; 
whether the Secretary should be required to approve guidance documents 
that fall into a broader or narrower category than significant guidance 
documents prior to publication; and the process for soliciting and 
responding to public comments.

D. Guidance Repository (Sec.  1.4)

    HHS proposes to make its guidance documents available to the public 
through the internet. The Department would establish a guidance 
repository on its website at www.hhs.gov/guidance. By November 2, 2020, 
the Department would be required to have posted to the guidance 
repository all guidance documents in effect that were issued by any 
component of the Department. The guidance repository would be required 
to be fully text searchable.
    Under this proposal, any web page in the guidance repository that 
contains guidance documents would clearly indicate that any guidance 
document previously issued by the Department would no longer be in 
effect and would be considered rescinded, if it is not included in the 
guidance repository by November 2, 2020. All web pages in the guidance 
repository containing guidance documents would also state that the 
guidance documents contained therein ``lack the force and effect of 
law, except as authorized by law or as specifically incorporated into a 
contract'' and ``the Department may not cite, use, or rely on any 
guidance that is not posted on the guidance repository, except to 
establish historical facts.''
    If the Department would desire to reinstate a rescinded guidance 
document not posted to the guidance repository by November 2, 2020, the 
Department would be able to do so only by following all requirements 
applicable to newly issued guidance documents.
    If this proposed rule is finalized, guidance documents issued after 
the effective date of the final regulation would be required to comply 
with all applicable requirements in section 1.3. HHS would be required 
to post a new or amended guidance document to the guidance repository 
within three business days of the date on which that guidance document 
was issued. For significant guidance documents issued

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after the effective date of the final regulation, HHS would be required 
to post proposed versions of significant guidance documents to the 
guidance repository as part of the notice-and-comment process. The 
Department shall clearly indicate the end of each significant guidance 
document's comment period and the mechanisms by which members of the 
public may submit comments on the proposed significant guidance 
document. The Department would also be required to post online all HHS 
responses to major public comments.
    HHS seeks comments on all proposed aspects of the guidance 
repository.

E. Procedure to Petition for Review of Guidance (Sec.  1.5)

    Regulated parties should have an opportunity for administrative and 
judicial review of whether a guidance document inappropriately creates 
new obligations or is being used by HHS to create new obligations. 
Under the proposed rule, any interested party would be able to petition 
HHS to withdraw or modify any particular guidance document. Such 
petitions would include requests to determine whether
     A guidance document, no matter how styled, imposes binding 
obligations on parties beyond what is required by the terms of 
applicable statutes and/or regulations.
     An HHS component is using a guidance document to create 
additional legal obligations beyond what is required by the terms of 
applicable statutes and/or regulations.
     HHS is improperly exempting a guidance document from the 
procedures set forth in this proposed rule.
    As part of this petition process proposed under this proposed rule, 
the interested party would be able to ask HHS to remedy the deficiency 
relating to the use or contents of the guidance document by modifying 
or withdrawing the guidance document.\2\
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    \2\ However, an interested party could not use this process to 
seek changes based on the quality of the information contained in a 
document; there are other processes to address the quality of 
information contained in HHS issuances.
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    Petitions under this proposed section would be addressed to HHS in 
writing. The guidance repository would include clear instructions to 
members of the public regarding how to petition for review of guidance, 
including how such petitions can be submitted and an HHS office 
responsible for coordinating such requests.
    To facilitate transparency and avoid duplication of work, under the 
proposed rule, HHS would publish all responses to petitions for 
guidance review in a designated section of its online guidance 
repository. If HHS were to receive multiple similar petitions within a 
short time period, it would be able to aggregate those petitions and 
respond to them in a single response, so long as all petitions were 
responded to within the appropriate time period. Under the proposed 
rule, HHS would respond to all petitions within 90 business days of the 
date on which the petition was received. The time period to respond 
would be suspended if HHS were to need to request additional 
information from the person who submitted the petition or to consult 
with other stakeholders. Under the proposed rule, HHS's response to any 
such petition would be considered final agency action reviewable in 
court, because it would mark the consummation of HHS's decision-making 
process and legal consequences flow from the response to the petition. 
See, e.g., Appalachian Power Co. v. E.P.A., 208 F.3d 1015, 1022 (D.C. 
Cir. 2000). OGC and the departmental division that authored the 
challenged guidance would be responsible for responding to all 
petitions received on the guidance document.
    HHS seeks comments on the proposed procedure to allow interested 
parties to petition the Department.

III. Rulemaking Analyses and Notices

A. Executive Orders 12866 and 13563

    Executive Orders 12866 and 13563, ``Improving Regulation and 
Regulatory Review,'' direct agencies to assess all costs and benefits 
of available regulatory alternatives and, if the regulation is 
necessary, to select regulatory approaches that maximize net benefits. 
A Regulatory Impact Analysis must be prepared for major rules with 
economically significant effects. The Department has determined that 
this rulemaking is not a significant regulatory action under these 
Executive orders. As such, the Department does not anticipate that this 
rulemaking will impose measurable costs on regulated parties. This 
proposed rule describes proposed agency processes for issuing guidance 
and responding to petitions regarding guidance that allegedly is 
inappropriate or is being used inappropriately. The Department proposes 
to adopt these procedures as part of its regulatory reform initiative. 
Implementation of this proposed rule would require HHS expenditures to 
create and maintain the guidance repository, along with employing a new 
process for the review of significant guidance documents and for the 
review of guidance documents which are the subject of a petition for 
review. The Department expects benefits to accrue as a result of the 
streamlined and clarified process of issuing guidance documents, in 
addition to positive consequences flowing from improved agency decision 
making. If this proposed rule is finalized, the Department anticipates 
that the public, and, in particular, regulated parties, would benefit 
from greater efficiencies and more transparency in how the Department 
operates and regulates.

B. Executive Order 13771

    This proposed rule is expected to be neither a regulatory nor a 
deregulatory action under E.O. 13771, ``Reducing Regulation and 
Controlling Regulatory Costs,'' because this rule is estimated to 
impose no more than de minimis costs on regulated entities.

C. Regulatory Flexibility Act

    The Department has examined the economic implications of this 
proposed rule as required by the Regulatory Flexibility Act (RFA), 5 
U.S.C. 601 et seq. The RFA requires an agency to describe the impact of 
a proposed rulemaking on small entities by providing an initial 
regulatory flexibility analysis, unless the agency determines that the 
proposed rule will not have a significant impact on a substantial 
number of small entities, provides a factual basis for this 
determination, and proposes to certify the statement. 5 U.S.C. 603(a) 
and 605(b). The Department considers a proposed or final rule to have a 
significant impact on a substantial number of small entities if it has 
at least a three percent impact on revenue on at least five percent of 
small entities. The Department anticipates that, if finalized, this 
proposed rule would allow small entities to operate more efficiently, 
by increasing the transparency of government regulation. As a result, 
the Department has determined, and the Secretary certifies, that this 
proposed rule would not have a significant impact on the operations of 
a substantial number of small entities.

D. Executive Order 13132 (Federalism)

    Executive Order 13132 establishes certain requirements that an 
agency must meet when it promulgates a rule that imposes substantial 
direct requirement costs on State and local governments or has 
federalism implications. The Department has determined that this 
proposed rule would not impose such costs or have any federalism 
implications.

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E. Paperwork Reduction Act of 1995

    In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. 
Ch. 3506; 5 CFR part 1320, appendix A.1), the Department has reviewed 
this proposed rule and has determined that it proposes no new 
collections of information.

List of Subjects in 45 CFR Part 1

    Guidance, Reporting and recordkeeping requirements.

0
For the reasons set forth in the preamble, the Department of Health and 
Human Services proposes to amend 45 CFR, subtitle A, subchapter A, by 
adding part 1 to read as follows:

PART 1--GOOD GUIDANCE PRACTICES

Sec.
1.1 Scope.
1.2 Definitions.
1.3 Requirements for Department issuance and use of guidance 
documents.
1.4 Guidance repository.
1.5 Procedure to petition for review of guidance.

    Authority: 42 U.S.C. 1302, 5 U.S.C. 301, 551 et seq.


Sec.  1.1  Scope.

    This part shall apply to guidance documents issued by all 
components of the Department, except the Food and Drug Administration, 
for which all requirements at 21 U.S.C. 371(h) and 21 CFR 10.115 shall 
continue to apply.


Sec.  1.2  Definitions.

    The following definitions apply to this part. Different definitions 
may be found in Federal statutes or regulations that apply more 
specifically to particular programs or activities.
    Guidance document means any Department statement of general 
applicability, intended to have future effect on the behavior of 
regulated parties and which sets forth a policy on a statutory, 
regulatory, or technical or scientific issue or an interpretation of a 
statute or regulation. The term ``guidance document'' does not include 
rules promulgated pursuant to notice and comment under 5 U.S.C. 553, or 
similar statutory provisions; rules exempt from rulemaking requirements 
under 5 U.S.C. 553(a); rules of agency organization, procedure, or 
practice; decisions of agency adjudications under 5 U.S.C. 554, or 
similar statutory provisions; internal guidance directed to the 
Department or other agencies that is not intended to have substantial 
future effect on the behavior of regulated parties; internal executive 
branch legal advice or legal opinions addressed to executive branch 
officials; legal briefs and other court filings; grant solicitations 
and awards; or contract solicitations and awards. Pre-enforcement 
rulings, i.e., communications with a person that interpret or apply the 
law to a specific set of facts, such as letter rulings, advisory 
opinions, no-action letters, and notices of noncompliance, do not 
constitute guidance documents. If, however, the Department issues such 
a document that on its face is directed to a particular party, but the 
content of the document is designed to guide the conduct of other 
regulated parties, such a document would qualify as guidance.
    Guidance repository means an online database containing or linking 
to guidance documents.
    Issued means the Department initiated or sponsored distribution of 
information to the public. ``Issued'' does not include distribution 
intended to be limited to government employees or agency contractors, 
or distribution required under law or agency disclosure policies.
    Significant guidance document means a guidance document that may 
reasonably be anticipated to lead to an annual effect on the economy of 
$100 million or more, or adversely affect in a material way the 
economy, a sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities; create a serious inconsistency or otherwise 
interfere with an action taken or planned by another agency; materially 
alter the budgetary impact of entitlements, grants, user fees, or loan 
programs or the rights or obligations of recipients thereof; or raise 
novel legal or policy issues arising out of legal mandates, the 
President's priorities, or the principles of Executive Order 12866. The 
term ``significant guidance document'' does not include the categories 
of documents exempted in writing by the Office of Management and 
Budget's (``OMB'') Office of Information and Regulatory Affairs 
(``OIRA'').


Sec.  1.3  Requirements for Department issuance and use of guidance 
documents.

    (a) Guidance documents. (1) Under the Administrative Procedure Act, 
the Department may not issue any guidance document that establishes a 
legal obligation that is not reflected in a duly enacted statute or in 
a regulation lawfully promulgated under a statute.
    (2) The Department may not use any guidance document for purposes 
of requiring a person or entity outside the Department to take any 
action, or refrain from taking any action, beyond what is required by 
the terms of an applicable statute or regulation.
    (3) Each guidance document issued by the Department must:
    (i) Identify itself as ``guidance'' (by using the term 
``guidance'') and include the following language, unless the guidance 
is authorized by law to be binding: ``The contents of this document do 
not have the force and effect of law and are not meant to bind the 
public in any way, unless specifically incorporated into a contract. 
This document is intended only to provide clarity to the public 
regarding existing requirements under the law.'';
    (ii) Not direct parties outside the Federal Government to take or 
refrain from taking action, except when restating--with citations to 
statutes, regulations, or binding judicial precedent--clear mandates 
contained in a statute or regulation; and
    (iii) Include the following information:
    (A) The activities to which and the persons to whom the document 
applies;
    (B) The date of issuance;
    (C) Unique agency identifier;
    (D) Whether the guidance document replaces or revises a previously 
issued guidance document and, if so, identify the guidance document 
that it replaces or revises;
    (E) Citation to the statutory provision(s) and/or regulation(s) (in 
Code of Federal Regulations format) that the guidance document is 
interpreting or applying; and
    (F) A short summary of the subject matter covered in the guidance 
document.
    (b) Significant guidance documents. (1) Before the Department 
issues any significant guidance document, it must be approved, on a 
non-delegable basis, by the Secretary.
    (2) Before issuing any significant guidance document, the 
Department must:
    (i) Submit the significant guidance document to OIRA for review 
under Executive Order 12866 prior to issuance.
    (ii) Provide at least a 30-day public notice and comment period on 
the proposed significant guidance document, unless the Department for 
good cause finds (and incorporates such finding and a brief statement 
of reasons therefor into the guidance document) that notice and public 
comment are impracticable, unnecessary, or contrary to the public 
interest. If no such good cause exists, the public notice (which must 
be published in the Federal Register and posted in the guidance 
repository) shall include all of the following information:

[[Page 51401]]

    (A) Information as to where the public may access a copy of the 
proposed significant guidance document;
    (B) Information as to where written comments may be sent, and an 
internet website where those comments may be reviewed by the public; 
and
    (C) The time period during which comments will be accepted.
    (iii) Publish a public response to the major concerns raised during 
the comment period.
    (3) Significant guidance documents must comply with applicable 
requirements for significant regulatory actions, as set forth in 
Executive orders, except that only economically significant guidance 
documents require a separate Regulatory Impact Analysis.
    (4) A significant guidance document may be exempted from any 
requirement otherwise applicable to significant guidance documents if 
the Secretary and the Administrator of OIRA agree that exigency, 
safety, health, or other compelling cause warrants the exemption. The 
Secretary must make this finding, and the significant guidance document 
must incorporate the finding and a brief statement of reasons in 
support.
    (5) The Department shall seek from OIRA, as appropriate, 
categorical determinations that classes of guidance presumptively do 
not qualify as significant. Any guidance satisfying such a categorical 
exemption presumptively need not comply with the requirements of this 
paragraph (b), but must comply with all other requirements applicable 
to guidance documents. OIRA may determine that a particular guidance 
document within a categorical exemption is nonetheless significant.


Sec.  1.4  Guidance repository.

    (a) Existing guidance. By [date 60 days after effective date of the 
final rule] the Department shall maintain a guidance repository on its 
website at www.hhs.gov/guidance.
    (1) The guidance repository shall be fully text searchable and 
contain or link to all guidance documents in effect that have been 
issued by any component of the Department.
    (2) If the Department does not include a guidance document in the 
guidance repository by November 2, 2020, the guidance document shall be 
considered rescinded.
    (3) Any web page in the guidance repository that contains or links 
to guidance documents must state:
    (i) That the guidance documents contained therein:
    (A) ``Lack the force and effect of law, except as authorized by law 
or as specifically incorporated into a contract.''; and
    (B) ``The Department may not cite, use, or rely on any guidance 
that is not posted on the guidance repository, except to establish 
historical facts.''
    (ii) That any guidance document previously issued by the Department 
is no longer in effect, and will be considered rescinded, if it is not 
included in the guidance repository.
    (4) If the Department wishes to reinstate a rescinded guidance 
document, the Department may do so only by complying with all of the 
requirements applicable to guidance documents issued after [effective 
date of the final rule].
    (b) Guidance issued after [effective date of the final rule]. (1) 
For all guidance documents issued after [effective date of the final 
rule], the Department must post each guidance document to the 
Department's guidance repository within three business days of the date 
on which that guidance document was issued.
    (2) For significant guidance documents issued after [effective date 
of the final rule], the Department shall post proposed new significant 
guidance to the guidance repository as part of the notice-and-comment 
process.
    (i) The posting shall clearly indicate the end of each significant 
guidance document's comment period and provide a means for members of 
the public to submit comments.
    (ii) The Department shall also post online all responses to major 
public comments.


Sec.  1.5  Procedure to petition for review of guidance.

    (a) Any interested party may petition the Department to withdraw or 
modify any particular guidance document. Such petitions may include 
requests to determine whether:
    (1) A guidance document, no matter how styled, imposes binding 
obligations on parties beyond what is required by the terms of 
applicable statutes and/or regulations;
    (2) A component of the Department is using a guidance document to 
create additional legal obligations beyond what is required by the 
terms of applicable statutes and/or regulations; or
    (3) The Department is improperly exempting a guidance document from 
the requirements set forth in this part.
    (b) As part of a petition under this section, an interested party 
may ask that the Department modify or withdraw any guidance document in 
effect at the time of the petition.
    (c) Petitions under this section must be addressed to the 
Department in writing. The Department's guidance repository must 
include clear instructions to members of the public regarding how to 
petition for review of guidance, including how such petition can be 
submitted, and an office at the Department responsible for coordinating 
such requests.
    (d) The Department must respond to all petitions no later than 90 
business days after receipt of the petition. The applicable time period 
for responding is suspended from the time the Department:
    (1) Requests additional information from the requestor, until the 
Department receives the additional information; or
    (2) Notifies the requestor of the need to consult with other 
stakeholders, including but not limited to the Department of Justice or 
the Department's Office of Inspector General, until the Department 
completes consultation with other stakeholders.
    (e) The Department will publish all responses to petitions under 
this section to a designated web page on its guidance repository.

    Dated: August 14, 2020.
Alex M. Azar II,
Secretary, Department of Health and Human Services.
[FR Doc. 2020-18208 Filed 8-17-20; 4:15 pm]
BILLING CODE 4150-26-P