[Federal Register Volume 85, Number 166 (Wednesday, August 26, 2020)]
[Proposed Rules]
[Pages 52515-52516]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-18744]


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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: Proposed rule; correction.

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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: August 18, 2020.

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:

I. Summary of Errors

    In FR Doc. 2020-18208, the notice of proposed rulemaking entitled 
``Department of Health and Human Services Good Guidance Practices'' 
(hereinafter referred to as the Good Guidance Practices Rule) there was 
an error in the proposed date by which 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 Good 
Guidance Practices Rule used the proposed date of November 2, 2020, but 
the correct date is November 16, 2020. Similarly, in several places the 
Good Guidance Practices Rule referred to a time period after ``the 
effective date of the final regulation'' or a date ``60 days after 
[the] effective date of the final rule''; these references throughout 
should be replaced with the correct proposed date of November 16, 2020.
    We are correcting our previous statement in the August 17, 2020 
notice of proposed rulemaking accordingly.
    Therefore, FR Proposed Rule Doc. 2020-18208, published August 20, 
2020, beginning on page 51396, is corrected as follows:

II. Correction of Errors in the Preamble

    1. On page 51398, in the first column, the second sentence is 
corrected to read as follows:
    ``If the proposed rule is finalized, following November 16, 2020, 
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.''
    2. On page 51398, in the first column, the first sentence of the 
second paragraph sentence is corrected to read as follows:
    ``HHS proposes to require that each guidance document issued by it 
or any component after November 16, 2020, 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.''
    3. On page 51398, in the third column, the third sentence of the 
second paragraph sentence is corrected to read as follows:
    ``By November 16, 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.''
    4. On page 51398, in the third column, the first sentence of the 
third paragraph sentence is corrected to read as follows:
    ``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 16, 2020.''

[[Page 52516]]

    5. On page 51398, in the third column, the fourth paragraph is 
corrected to read as follows:
    ``If the Department would desire to reinstate a rescinded guidance 
document not posted to the guidance repository by November 16, 2020, 
the Department would be able to do so only by following all 
requirements applicable to newly issued guidance documents.''
    6. On page 51398, in the third colum, the first sentence of the 
fifth paragraph is corrected to read as follows:
    ``If this proposed rule is finalized, guidance documents issued 
after November 16, 2020 would be required to comply with all applicable 
requirements in Sec.  1.3.''
    7. On pages 51398-51399, in the third column, the last sentence in 
the fifth paragraph is corrected to read as follows:
    ``For significant guidance documents issued after November 16, 
2020, HHS would be required to post proposed versions of significant 
guidance documents to the guidance repository as part of the notice-
and-comment process.''

III. Correction of Errors in Proposed Regulation Text

    On page 51401, in the first column, added Sec.  1.4 is corrected to 
read as follows:


Sec.  1.4  Guidance repository.

    (a) Existing guidance. By November 16, 2020, 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 16, 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 November 16, 
2020.
    (b) Guidance issued after November 16, 2020. (1) For all guidance 
documents issued after November 16, 2020, 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 November 16, 
2020, the Department shall post proposed new significant guidance to 
the guidance repository as part of the notice-and-comment process.
    (ii) 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.

    Dated: August 21, 2020.
Wilma M. Robinson,
Deputy Executive Secretary to the Department, Department of Health and 
Human Services.
[FR Doc. 2020-18744 Filed 8-24-20; 11:15 am]
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