[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Rules and Regulations]
[Pages 55907-55915]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19736]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20 and 720

[Docket No. FDA-2018-N-1622]
RIN 0910-AH69


Public Information

AGENCY: Food and Drug Administration, Department of Health and Human 
Services (HHS).

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
issuing a final rule amending its public information regulations. The 
final rule revises the current regulations to incorporate changes made 
to the Freedom of Information Act (FOIA) by the Openness Promotes 
Effectiveness in our National Government Act of 2007 (OPEN Government 
Act) and the FOIA Improvement Act of 2016 (FOIA Improvement Act). 
Additionally, the final rule updates the current regulations to reflect 
changes to the organizational structure of FDA, to make the FOIA 
process easier for the public to navigate, and to make provisions 
clearer.

DATES: This rule is effective October 13, 2022.

ADDRESSES: For access to the docket to read background documents or 
comments received, go to https://www.regulations.gov and insert the 
docket number found in brackets in the heading of this final rule into 
the ``Search'' box and follow the prompts, and/or go to the Dockets 
Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 
240-402-7500.

FOR FURTHER INFORMATION CONTACT: Sarah B. Kotler, Office of the 
Commissioner, Office of the Executive Secretariat, Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1050, Rockville, MD 20857, 301-
796-3900, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Executive Summary
    A. Purpose of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Table of Abbreviations and Acronyms Commonly Used in This 
Document
III. Background
IV. Legal Authority
V. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Description of Comments Regarding 21 CFR parts 20 and 720
    C. Description of Comments Outside the Scope of This Rulemaking
VI. Description of the Final Rule
VII. Effective Date
VIII. Economic Analysis of Impacts
IX. Analysis of Environmental Impact
X. Paperwork Reduction Act of 1995
XI. Federalism
XII. Consultation and Coordination With Indian Tribal Governments

I. Executive Summary

A. Purpose of the Final Rule

    FDA is issuing this final rule to amend FDA's public information 
regulations. The regulations are being amended to incorporate changes 
made to the FOIA by the OPEN Government Act and the FOIA Improvement 
Act. Additionally, the final rule updates the regulations to reflect 
changes to the organizational structure of FDA, makes the FOIA process 
easier for the public to navigate, and makes certain provisions 
clearer. Taken together, these changes enhance transparency for the 
public about FDA activities.

B. Summary of the Major Provisions of the Final Rule

    The amendments to FDA's public information regulations bring the 
Agency's regulations in line with statutory amendments to the FOIA, 
update cross references to other statutes and parts of the Agency's 
regulations, and clarify certain provisions with minor editorial 
updates.

C. Legal Authority

    These amendments to FDA's public information regulations are based 
on our authority under the FOIA and the Federal Food, Drug, and 
Cosmetic Act (FD&C Act). These amendments allow FDA to more efficiently 
use its resources to provide information to the public.

D. Costs and Benefits

    Although FDA is currently implementing the requirements of the OPEN 
Government Act and the FOIA Improvement Act in FOIA processing as 
standard practice, the requirements are not currently reflected in FDA 
regulations. The revisions made by this final rule are intended to 
incorporate all current FOIA requirements into the existing 
regulations. Because the Agency has already adopted many of these 
requirements, we anticipate no additional costs or benefits from this 
final rule.

II. Table of Abbreviations and Acronyms Commonly Used in This Document

------------------------------------------------------------------------
           Abbreviation/Acronym                     What it means
------------------------------------------------------------------------
FOIA......................................  Freedom of Information Act.
FOIA Improvement Act......................  FOIA Improvement Act of
                                             2016.
OGIS......................................  Office of Government
                                             Information Services.
OPEN Government Act.......................  Openness Promotes
                                             Effectiveness in our
                                             National Government Act of
                                             2007.
------------------------------------------------------------------------

III. Background

    The FOIA (5 U.S.C. 552) is a law that gives the public the right to 
access information from the Federal Government. There is a presumption 
that government records must be released under the FOIA unless they are 
subject to one of nine FOIA exemptions. FDA's regulations for the 
implementation of the FOIA are in part 20 of title 21 of the Code of 
Federal

[[Page 55908]]

Regulations (CFR). The FOIA Improvement Act (Pub. L. 114-185) 
specifically requires agencies to review their FOIA regulations and 
update their regulations for the disclosure of records in accordance 
with its amendments.

IV. Legal Authority

    These amendments to FDA's public information regulations are based 
on FDA's authority under the FOIA and section 701(a) of the FD&C Act 
(21 U.S.C. 371(a)). These revised regulations allow FDA to more 
efficiently use its resources to provide information to the public.

V. Comments on the Proposed Rule and FDA Response

A. Introduction

    FDA received comments on the proposed rule (83 FR 46437, September 
13, 2018) (hereinafter referred to as the proposed rule) from industry, 
various entities, academia, and individuals. A summary of the comments 
submitted to the docket and the Agency's responses follow. We have 
numbered each comment to help distinguish among different comments. We 
have grouped similar comments together under the same number and, in 
some cases, we have separated different issues discussed in the same 
comment and designated them as distinct comments for purposes of the 
responses. The number assigned to each comment or comment topic is 
purely for organizational purposes and does not signify the comment's 
value or importance, or the order in which comments were received.

B. Description of Comments Regarding 21 CFR Parts 20 and 720

    (Comment 1) One comment supported the proposed rule.
    (Response 1) We acknowledge and appreciate the supportive comment.
    (Comment 2) One comment expressed concern with FDA's 
characterization of the foreseeable harm standard with respect to 
discretionary disclosures and requested that FDA clarify that ``such 
disclosures are mandatory'' under 5 U.S.C. 552(8)(A).
    (Response 2) Although the commenter identified 5 U.S.C. 552(8)(A), 
based on the content of the comment, we presume the commenter meant to 
identify 5 U.S.C. 552(a)(8)(A). FDA has revised the provision for 
clarity and to conform more closely to the text of 5 U.S.C. 
552(a)(8)(A).
    (Comment 3) One comment ``applaud[ed] the proposed revisions to 
Sec.  20.20(c) [21 CFR 20.20(c)], which require the FDA to identify 
records of general interest to the public for posting on its website.'' 
This comment also requests that FDA ``take the opportunity to re-
examine and implement the recommendations contained in the `Blueprint 
for Transparency at the U.S. Food and Drug Administration', which 
provides a list of proactive changes that FDA can make to increase 
transparency under existing law.''
    (Response 3) FDA appreciates this comment. In an effort to make the 
FOIA process easier for the public to navigate, FDA proposed this rule 
to provide clarity and consistency regarding the public's access to 
records. FDA believes the changes will promote transparency by reducing 
the amount of information withheld when the Agency has discretion to 
determine what will be withheld under the FOIA exemptions and will make 
release of information more efficient through the use of information 
technology.
    (Comment 4) One comment requested clarification of the codified 
language of Sec.  20.26(a)(4) [21 CFR 20.26(a)(4)]. The comment 
expressed concern that the language used to reflect the new statutory 
requirement for FDA to make available for public inspection all records 
``that have been released to any person'' pursuant to a FOIA request 
and ``that have been requested three or more times'' may be 
misconstrued. The comment asserted that, as drafted, the proposed 
revision does not make clear that records required to be made available 
for public inspection must have been previously released to a person 
pursuant to a FOIA request. Rather, the wording of the proposal ``could 
be interpreted to authorize the release of any records that have been 
requested three or more times, regardless of whether these records have 
previously been released under the FOIA or are protected from 
disclosure pursuant to an applicable FOIA exemption.''
    (Response 4) After considering this comment, FDA has amended the 
provision to make clear that Sec.  20.26(a)(4) applies only to records 
that have been released to any person under the FOIA. Specifically, the 
provision now refers to records that have been released to any person 
in response to a FOIA request, and that (1) the Agency has determined 
have become, or are likely to become, the subject of subsequent FOIA 
requests for substantially the same records, or (2) have been requested 
three or more times under the Freedom of Information Act.
    (Comment 5) One comment supported revisions to Sec.  20.26(a)(4) to 
make records that have been released to any person pursuant to a FOIA 
request available on the electronic reading room site, after three FOIA 
requests have been made for the same records. The comment requested 
that FDA ``promptly comply with the requirements for posting documents 
on its website after three FOIA requests are received.''
    (Response 5) Where a record has been released to any person in 
response to a FOIA request and has been requested three or more times 
under the FOIA, FDA intends to publicly post the record.
    (Comment 6) One comment requested that FDA ``provide more 
information about the processing of FOIA requests, including applicable 
timelines, to enhance predictability and transparency.'' The comment 
asserted that ``there currently are no clear agency timelines 
associated with the processing of FOIA requests and no clear mechanism 
for a requester to learn the status of its FOIA request.'' 
Specifically, the request asked for ``more information about how it 
processes FOIA requests and the estimated timelines associated with 
each step (such as through a process flow diagram)'' and the allowance 
of ``sufficient time and flexibility to account for the redaction of 
protected information.''
    (Response 6) FDA appreciates suggestions to improve the FOIA 
process and intends to take this comment into consideration when 
developing and revising processes. FDA believes including these as 
requirements in part 20 is not needed and could be unduly inflexible.
    (Comment 7) One comment requested that FDA modify Sec.  20.41(a) 
[21 CFR 20.41(a)] to include language ``clearly stating that any time 
limitation calculations begin at the time of receipt of a request, not 
the time that the request is logged.'' The comment asserted that 
``[Sec.  ] 20.41 of the FDA's current FOIA regulations--which is not 
addressed by the Proposed Rule--calculates various time limitations 
under the Act starting at `the time at which a request for records is 
logged in by the Division of Freedom of Information pursuant to Sec.  
20.40(c) [21 CFR 20.40(c)].' ''
    (Response 7) FDA is required by the FOIA to ``determine within 20 
days (excepting Saturdays, Sundays, and legal public holidays) after 
the receipt of [a] request whether to comply with such request'' (5 
U.S.C 552(a)(6)(A)(i)). The FOIA states that the 20-day period 
commences ``on the date on which the request is first received by the 
appropriate component of the agency, but in any event not later than 
ten days after the request is first received by any component of the 
agency that is designated in the agency's regulations

[[Page 55909]]

. . . to receive [FOIA] requests'' (5 U.S.C. 552(a)(6)(A)(ii)). FDA 
logs requests in accordance with its statutory obligations pursuant to 
Sec.  20.40(c), which establishes the date used to calculate time 
limitations under Sec.  20.41(a).
    (Comment 8) One comment requested that FDA modify Sec.  20.44(e) 
[21 CFR 20.44(e)] to reflect the same language in 5 U.S.C. 552 
(a)(6)(E)(ii)(I), which provides that ``a determination of whether to 
provide expedited processing shall be made, and notice of the 
determination shall be provided to the person making the request, 
within 10 days after the date of the request.'' The language of the 
proposed rule states that FDA ``will determine whether to grant a 
request for expedited processing within 10 days of receipt by the 
Division of Freedom of Information of all information required to make 
a decision.'' (83 FR 46437 at 46441) The comment asserted that because 
the proposed rule does not include a definition of what is considered 
to be ``all information required to make a decision'' in a request for 
expedited processing, the language should be revised to mirror 5 U.S.C. 
552(a)(6)(E)(ii)(I).
    (Response 8) FDA has provided for a decision within the 10-day 
period when it is possible based on the information submitted to the 
Agency. Agencies are required to provide for expedited processing of 
FOIA requests in cases where requests for expedited processing show a 
compelling need. However, the FOIA also permits agencies to grant 
expedited processing in other cases as determined by the Agency. In 
those instances where the requester does not meet the statutory 
definition of ``compelling need'' but demonstrates a need for expedited 
processing, the Agency has the discretion to grant such requests based 
on all information required to make a decision. We do not provide a 
definition of ``all information required to make a decision'' as the 
circumstances of each situation are unique and a decision is made on a 
case-by-case-basis. In some situations, FDA may ask the requester for 
additional information rather than deny the request for expedited 
process on the basis that it did not meet the required showing.
    (Comment 9) One comment asked that FDA ``update its FOIA 
regulations to expressly require consultation and/or notification when 
any such information may possibly be viewed as trade secret or 
confidential commercial information. FDA, as part of such an 
initiative, should also adequately ensure that submitters of sensitive 
information throughout the supply chain are actually notified.'' The 
comment asserted that newly promulgated regulations under the FDA Food 
Safety Modernization Act (Pub. L. 111-353) ``require the submission of 
an unprecedented amount of information held by firms throughout the 
food supply chain, meaning such records will potentially be subject to 
public disclosure upon submission of an appropriate FOIA request or 
through other voluntary disclosure by FDA.''
    Currently, Sec.  20.47 provides that in situations where the 
confidentiality of data or information is uncertain and there is a 
request for public disclosure, FDA will consult with the person who has 
submitted or divulged the data or information or who would be affected 
by disclosure before determining whether or not such data or 
information is available for public disclosure. Section 20.61 [21 CFR 
20.61] further provides that ``when the agency has substantial reason 
to believe that information in [requested] records could reasonably be 
considered exempt under [E]xemption 4'' the Agency must ``make 
reasonable efforts to notify the submitter about these facts.'' The 
comment alleged that although ``these regulations provide for submitter 
consultation and notification in certain circumstances, in practice, 
FDA frequently response (sic) to requests for this information without 
first engaging with submitters.'' Importantly, even though ``FOIA 
itself does not require agencies to notify submitters that confidential 
business information may be subject to disclosure, agencies must 
provide for submitter notification in their regulations or through 
other procedures under Executive Order 12600.''
    (Response 9) FDA believes no change to the provision is needed 
because where confidentiality of data or information is uncertain, FDA 
will consult with the person who submitted the information ``or who 
would be affected by the disclosure.''
    Agency regulations currently satisfy the requirements of Executive 
Order 12600, and we do not believe a change is otherwise warranted.
    (Comment 10) One comment requested that FDA modify Sec.  20.88(d) 
[21 CFR 20.88(d)] to clarify that FDA cannot ask State or local 
government entities to enter into contracts that would violate State 
law.
    (Response 10) The final rule adopts the language proposed in Sec.  
20.88(d) and does not require State or local government entities to 
enter into contracts or other agreements that conflict with the 
requirements of their State public record laws. Under Sec.  
20.88(d)(1)(i), the State or local government agency must first provide 
a written statement establishing its authority to protect confidential 
commercial information from public disclosure. In providing a written 
statement to this effect, the State or local government agency should 
determine whether it has the necessary authority under State law to 
protect confidential commercial information. If so, the written 
agreement to protect such information should not conflict with State 
law. Furthermore, a written agreement would not override a State's 
obligation to comply with applicable law. If the State or local agency 
determines that it does not have such authority, it will be unable to 
provide a written statement and FDA, in turn, will be unable to 
authorize the disclosure of confidential commercial information to the 
State or local government agency.

C. Description of Comments Outside the Scope of This Rulemaking

    (Comment 11) One comment suggested that FDA request funding to hire 
sufficient additional staff to expedite response capability pursuant to 
Sec.  20.41.
    (Response 11) The suggestion is outside the scope of this 
rulemaking.
    (Comment 12) One comment suggested that publicly released FOIA logs 
should include metadata such as type of file/document released, size of 
the file/document released, and number of rows per file if data files 
are released.
    (Response 12) The suggestion is outside the scope of this 
rulemaking.
    (Comment 13) One comment suggested that exemptions used by the 
Federal Government should be restricted as a matter of public policy, 
especially when it comes to FDA.
    (Response 13) The suggestion is outside the scope of this 
rulemaking.

VI. Description of the Final Rule

    We are amending provisions of 21 CFR part 20 regarding the Agency's 
public information regulations. Once effective, the amendments 
contained in this rule will apply to all FOIA requests currently 
pending with, or received in the future by, FDA.
     The amendments to Sec.  20.20 require FDA to withhold 
information under the FOIA only if the Agency reasonably foresees that 
disclosure would harm an interest protected by an exemption or 
disclosure is prohibited by law. The rule further amends this provision 
to require FDA to establish procedures for identifying records of 
general interest or use to the public that are appropriate for public 
disclosure, and for posting such records in a publicly accessible

[[Page 55910]]

electronic format. These changes promote transparency by reducing the 
amount of information that will be withheld when the Agency has 
discretion to determine what will be withheld under the FOIA 
exemptions, and will make release of information more efficient through 
the use of information technology. These amendments are required by the 
FOIA Improvement Act and are currently part of FDA's FOIA policy and 
procedures.
     The amendment to 21 CFR 20.22 requires FDA to indicate the 
exemption(s) under which information has been deleted at the site of 
the deletion. This change will inform requesters of the legal bases 
under which information has been withheld from Agency records, which 
promotes transparency. This change is required by the OPEN Government 
Act (Pub. L. 110-175) and was adopted by the Agency for FOIA processing 
as of the effective date of the OPEN Government Act.
     The amendment to Sec.  20.26 requires FDA to make 
available for public inspection in an electronic format records that 
have been requested three or more times under the FOIA and have been 
released to a requester under the FOIA. This change codifies the long-
standing Department of Justice policy of Federal agencies posting 
records that have been requested three or more times. The purpose of 
this change is to proactively release records to the public without the 
need for submission of additional FOIA requests. This change is 
required by the FOIA Improvement Act.
     The amendment to 21 CFR 20.33 requires FDA to include in 
FOIA response letters the contact information for the Office of 
Government Information Services (OGIS) and the FOIA Public Liaison. 
This change provides requesters with additional avenues for resolving 
FOIA-related disputes beyond the appeals process. This provision is 
required by the FOIA Improvement Act.
     The amendment to Sec.  20.40 [21 CFR 20.40] updates the 
provision to include reference to the Agency's online FOIA submission 
portal, which has been operational since June 2012.
     The amendment to Sec.  20.41 requires that when FDA 
extends the time limit to respond to requests by up to10 additional 
working days, FDA must notify the requester in writing of the right to 
contact the FOIA Public Liaison and to seek dispute resolution services 
from the OGIS. This change provides requesters with additional avenues 
for resolving FOIA-related disputes beyond the appeals process. We 
further amended the provision to provide that if a court determines 
that exceptional circumstances exist, the Agency's failure to comply 
with a time limit shall be excused for the length of time provided by 
the court order. These changes are required by the FOIA Improvement 
Act. The revised provision further clarifies that the Agency may toll 
the response period once while it is awaiting a response from the 
requester regarding clarification that it has reasonably requested from 
the requester and more than once (if necessary) while the Agency is 
awaiting a response from the requester regarding fee assessment. This 
revision is required by the OPEN Government Act. Finally the revised 
provision contains minor updates regarding the appeal of an adverse 
determination.
     The amendment to Sec.  20.44 updates the title of the 
Agency official making determinations regarding requests for expedited 
processing.
     The amendments to 21 CFR 20.45 modify the fee schedule to 
prohibit the Agency from assessing fees if the Agency fails to comply 
with time limits to respond and there are no unusual or exceptional 
circumstances that apply to the processing of the request. If unusual 
circumstances apply, these amendments establish a process by which the 
Agency can work with the requester to effectively limit the scope of 
the request. These changes provide an incentive to the Agency to 
process requests as efficiently as possible and provide fee relief to 
requesters who do not receive FOIA responses in a timely manner. These 
provisions are required by the OPEN Government Act. Further amendments 
to this provision clarify how fees are calculated.
     The rule amends Sec.  20.49(c) [21 CFR 20.49(c)] to 
require full and partial denial letters to include contact information 
for the FOIA Public Liaison and OGIS, and to establish a 90 calendar 
day timeframe for transmittal of an appeal. We also made technical 
revisions to Sec.  20.49(a) to update the position title of the person 
who signs a denial of a request for records and to Sec.  20.49(c) 
regarding information provided about appeals. These changes provide 
requesters with additional avenues for resolving FOIA-related disputes 
beyond the appeals process and provide requesters with additional time 
to decide whether to pursue an appeal. Some of these amendments are 
required by the FOIA Improvement Act.
     The rule amends Sec.  20.61(e)(2) to allow 10 days from 
the date of the notice for submitters of trade secrets or confidential 
commercial information to object to disclosure. The revised provision 
further states that the Division of Freedom of Information may extend 
this period as appropriate and necessary. This change brings the Agency 
in line with HHS regulations in 45 CFR 5.42(a)(2).
     The rule amends 21 CFR 20.62 to prohibit the application 
of the deliberative process privilege under Exemption 5 of the FOIA to 
records created 25 years or more before the date on which the records 
were requested. This change increases transparency by requiring the 
Agency to release information that could otherwise fall within the 
deliberative process privilege. This amendment is required by the FOIA 
Improvement Act.
     The amendment to 21 CFR 20.82 clarifies the discretionary 
disclosure standard outlined in that provision that guides the Agency's 
determination to disclose requested information, taking into account 
whether disclosure of information would reasonably foreseeably harm an 
interest protected by an exemption or is prohibited by law as required 
in administering Sec.  20.20.
     The amendment to 21 CFR 20.85 updates the statutory 
references.
     The amendment to 21 CFR 20.86 clarifies that the list of 
proceedings subject to the provision is not exclusive.
     The amendments to Sec.  20.88 clarify that the provisions 
also apply to local officials and remove references to position titles 
that no longer exist.
     The amendments to 21 CFR 20.89 remove references to 
position titles that no longer exist.
     The amendments to 21 CFR 20.100 update the regulatory 
cross-references.
     The amendment to 21 CFR 20.120 updates the contact 
information for the Agency's reading rooms.
     The amendment to 21 CFR 720.8 revises the request for 
confidentiality of the identity of a cosmetic ingredient provision for 
consistency with FDA's disclosure regulation at 21 CFR 20.29.

VII. Effective Date

    This rule is effective October 13, 2022.

VIII. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive

[[Page 55911]]

impacts; and equity). This final rule is not a significant regulatory 
action as defined by Executive Order 12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the proposed revisions do not impose any burdens on 
FOIA requesters, including those that might be small entities, we 
certify that the final rule will not have a significant economic impact 
on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $165 
million, using the most current (2021) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    We expect to incur only negligible costs associated with 
implementing this rule. These costs result from updating titles of 
Agency officials, providing some additional information to FOIA 
requesters, and compiling information for annual reports. These 
requirements would not require more resources from us because we would 
perform these actions as part of routine FDA practices for FOIA 
processing. The rule enhances public access to government information 
as required by the FOIA Improvement Act.

IX. Analysis of Environmental Impact

    We have determined under 21 CFR 25.30(h) that this action is of a 
type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

X. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

XI. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, we conclude that the rule 
does not contain policies that have federalism implications as defined 
in the Executive order and, consequently, a federalism summary impact 
statement is not required.

XII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this rule in accordance with the principles set 
forth in Executive Order 13175. We have determined that the rule does 
not contain policies that have substantial direct effects on one or 
more Indian Tribes, on the relationship between the Federal Government 
and Indian Tribes, or on the distribution of power and responsibilities 
between the Federal Government and Indian Tribes. Accordingly, we 
conclude that the rule does not contain policies that have tribal 
implications as defined in the Executive order and, consequently, a 
tribal summary impact statement is not required.

List of Subjects

21 CFR Part 20

    Confidential business information, Courts, Freedom of information, 
Government employees.

21 CFR Part 720

    Confidential business information, Cosmetics.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
20 and 720 are amended as follows:

PART 20--PUBLIC INFORMATION

0
1. The authority citation for part 20 continues to read as follows:

    Authority:  5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 
21 U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.

0
2. Revise Sec.  20.20 to read as follows:


Sec.  20.20  Policy on disclosure of Food and Drug Administration 
records.

    (a) The Food and Drug Administration (FDA) will make the fullest 
possible disclosure of records to the public, consistent with the 
rights of individuals to privacy, the property rights of persons in 
trade secrets and confidential commercial or financial information, and 
the need for the Agency to promote frank internal policy deliberations 
and to pursue its regulatory activities without disruption.
    (b) Except where specifically exempt pursuant to the provisions of 
this part, all FDA records shall be made available for public 
disclosure. FDA will withhold requested information only if:
    (1) The Agency reasonably foresees that disclosure would harm an 
interest protected by an exemption described in this part; or
    (2) Disclosure is prohibited by law.
    (c) Except as provided in paragraph (d) of this section, all 
nonexempt records shall be made available for public disclosure upon 
request regardless of whether any justification or need for such 
records have been shown.
    (d) Under Sec.  21.71 of this chapter, a statement of the purposes 
to which the record requested is to be put, and a certification that 
the record will be so used, may be requested when:
    (1) The requested record is contained in a Privacy Act Record 
System as defined in Sec.  21.3(c) of this chapter;
    (2) The requester is a person other than the individual who is the 
subject of the record that is so retrieved or a person acting on his 
behalf; and
    (3) The disclosure is one that is discretionary; i.e., not required 
under this part.
    (e) ``Record'' and any other term used in this part in reference to 
information includes any information that would be an Agency record 
subject to the requirements of this part when maintained by the Agency 
in any format, including an electronic format.
    (f) FDA will establish procedures for identifying records of 
general interest or use to the public that are appropriate for public 
disclosure, and for posting and indexing such records in a publicly 
accessible electronic format.

0
3. In Sec.  20.22, add paragraph (b)(3) to read as follows:


Sec.  20.22   Partial disclosure of records.

* * * * *
    (b) * * *
    (3) The exemption(s) under which the information has been deleted 
shall be noted at the site of the deletion.

0
4. In Sec.  20.26, revise the section heading and paragraphs (a) 
introductory text, (a)(4), and (b) to read as follows:


Sec.  20.26   Electronic availability and indexes of certain records.

    (a) Indexes shall be maintained, and revised at least quarterly, 
and, as required, copies of electronic records

[[Page 55912]]

shall be made available for the following Food and Drug Administration 
records:
* * * * *
    (4) Records that have been released to any person in response to a 
Freedom of Information request, and that:
    (i) The Agency has determined have become, or are likely to become, 
the subject of subsequent Freedom of Information requests for 
substantially the same records; or
    (ii) Have been requested three or more times under the Freedom of 
Information Act.
    (b) Each such record and index will be made available by accessing 
the Agency's website at https://www.fda.gov. A printed copy of each 
index is available by writing or visiting the Freedom of Information 
Staff's address on the Agency's website at https://www.fda.gov.

0
5. In Sec.  20.33, add paragraph (c) to read as follows:


Sec.  20.33   Form or format of response.

* * * * *
    (c) Response letters shall contain contact information for the 
Freedom of Information Act (FOIA) Public Liaison and the Office of 
Government Information Services.

0
6. In Sec.  20.40, revise paragraph (a) to read as follows:


Sec.  20.40   Filing a request for records.

    (a) All requests for Food and Drug Administration records shall be 
made in writing by mailing or delivering the request to the Freedom of 
Information Staff at the address on the Agency's website at https://www.fda.gov, by faxing it to the fax number listed on the Agency's 
website at https://www.fda.gov, or by submission through the Agency's 
online FOIA submission portal at https://www.fda.gov. All requests must 
contain the postal address and telephone number of the requester and 
the name of the person responsible for payment of any fees that may be 
charged.
* * * * *

0
7. In Sec.  20.41:
0
a. Revise paragraph (b)(3)(i)(A);
0
b. Redesignate paragraph (b)(4) as paragraph (b)(5);
0
c. Add a new paragrpah (b)(4);
0
d. Revise newly redesignated paragraph (b)(5); and
0
e. Add paragraph (d).
    The revisions and additions read as follows:


Sec.  20.41   Time limitations.

* * * * *
    (b) * * *
    (3)(i) * * *
    (A) The Agency may provide for an extension of up to 10 working 
days by providing written notice to the requester setting out the 
reasons for the extension and the date by which a determination is 
expected to be sent. In the written notice, the Agency will inform the 
requester of the right to contact the Freedom of Information Act Public 
Liaison and to seek dispute resolution services from the Office of 
Government Information Services.
* * * * *
    (4) The Agency may contact the requester for clarification about 
the request or regarding fee assessment. The Agency may toll the 20-day 
period as follows:
    (i) One time while it is awaiting a response from the requester 
regarding clarification that it has reasonably requested from the 
requester; and
    (ii) One or more times while the Agency is awaiting a response from 
the requester regarding fee assessment.
    (5) If any record is denied, the letter shall state the right of 
the person requesting such record to appeal any adverse determination 
to the appropriate review official, in accordance with the provisions 
of 45 CFR 5.62.
* * * * *
    (d) If a court determines that exceptional circumstances exist, as 
defined by the Freedom of Information Act, the Agency's failure to 
comply with a time limit shall be excused for the length of time 
provided by the court order.

0
8. In Sec.  20.44, revise paragraph (e) to read as follows:


Sec.  20.44   Expedited processing.

* * * * *
    (e) The Director, Division of Freedom of Information, (or 
delegatee) will determine whether to grant a request for expedited 
processing within 10 days of receipt by the Division of Freedom of 
Information of all information required to make a decision.
* * * * *

0
9. In Sec.  20.45, revise paragraphs (a)(1) through (3), add paragraph 
(b)(7), and revise paragraphs (c)(1) and (2) to read as follows:


Sec.  20.45   Fees to be charged.

    (a) * * *
    (1) Commercial use request. If the request is for a commercial use, 
the Food and Drug Administration will charge for the costs of search, 
review, and duplication. The Agency shall not assess search fees if the 
Agency fails to comply with any time limit, as described in Sec.  
20.41, if no unusual or exceptional circumstances apply to the 
processing of the request. If unusual circumstances, as outlined in 
Sec.  20.41, apply and more than 5,000 pages are responsive to the 
request, the Food and Drug Administration may charge search fees if 
timely written notice has been made to the requester and the Agency has 
discussed with the requester via written mail, electronic mail, or 
telephone (or made not less than three good-faith attempts to do so) 
how the requester could effectively limit the scope of the request.
    (2) Educational and scientific institutions and news media. If the 
request is from an educational institution or a noncommercial 
scientific institution, operated primarily for scholarly or scientific 
research, or a representative of the news media, and the request is not 
for a commercial use, the Food and Drug Administration will charge only 
for the duplication of documents. Also, the Food and Drug 
Administration will not charge the copying costs for the first 100 
pages of duplication (or its cost equivalent of other media). The 
Agency shall not assess duplication fees if the Agency fails to comply 
with any time limit, as described in Sec.  20.41, if no unusual or 
exceptional circumstances apply to the processing of the request. If 
unusual circumstances, as outlined in Sec.  20.41, apply and more than 
5,000 pages are responsive to the request, the Food and Drug 
Administration may charge duplication fees if timely written notice has 
been made to the requester and the Agency has discussed with the 
requester via written mail, electronic mail, or telephone (or made not 
less than three good-faith attempts to do so) how the requester could 
effectively limit the scope of the request.
    (3) Other requests. If the request is not the kind described in 
paragraph (a)(1) or (a)(2) of this section, then the Food and Drug 
Administration will charge only for the search and the duplication. 
Also, the Food and Drug Administration will not charge for the first 2 
hours of search time or for the copying costs of the first 100 pages of 
duplication (or the cost equivalent of other media). The Agency shall 
not assess search or duplication fees if the Agency fails to comply 
with any time limit, as described in Sec.  20.41, if no unusual or 
exceptional circumstances apply to the processing of the request. If 
unusual circumstances, as outlined in Sec.  20.41, apply and more than 
5,000 pages are responsive to the request, the Food and Drug 
Administration may charge search or duplication fees if timely written 
notice has been made to the requester and the Agency has discussed with 
the requester

[[Page 55913]]

via written mail, electronic mail, or telephone (or made not less than 
three good-faith attempts to do so) how the requester could effectively 
limit the scope of the request.
    (b) * * *
    (7) Requesters may contact Agency Freedom of Information Act staff 
or the Freedom of Information Act Public Liaison to assist in 
reformulating a request to meet their needs at lower cost.
    (c) * * *
    (1) Manual searching for or reviewing of records. When the search 
or review is performed by employees at grade GS-1 through GS-8 (or 
equivalent), an hourly rate based on the salary of a GS-5, step 7, 
employee; when done by a GS-9 through GS-14 (or equivalent), an hourly 
rate based on the salary of a GS-12, step 4, employee; and when done by 
a GS-15 or above (or equivalent), an hourly rate based on the salary of 
a GS-15, step 7, employee. In each case, the hourly rate will be 
computed by taking the current hourly rate for the specified grade and 
step in the General Schedule Locality Pay Table for the Locality of 
Washington-Baltimore-Northern Virginia, DC-MD-VA-WV-PA, adding 16 
percent of that rate to cover benefits, and rounding to the nearest 
whole dollar. When a search involves employees at more than one of 
these levels, the Food and Drug Administration will charge the rate 
appropriate for each.
    (2) Electronic searching. Charges for the time spent by the 
operator to search the computer, database, or network, including 
development of any specialized programming required to perform the 
search, at the rate given in paragraph (c)(1) of this section plus the 
cost of any materials.
* * * * *

0
10. In Sec.  20.49:
0
a. Revise paragraphs (a) and (c); and
0
b. Remove paragraph (d).
    The revisions read as follows:


Sec.  20.49   Denial of a request for records.

    (a) A denial of a request for records, in whole or in part, shall 
be signed by the Director, Division of Freedom of Information (or 
delegatee).
* * * * *
    (c) A letter denying a request for records, in whole or in part, 
shall state the reasons for the denial, the appropriate review official 
and address to which the appeal should be sent, and that an appeal must 
be transmitted within 90 calendar days from the date of the adverse 
determination, in accordance with 45 CFR 5.61. The Agency will also 
make a reasonable effort to include in the letter an estimate of the 
volume of the records denied, unless providing such an estimate would 
harm an interest protected by an exemption under the Freedom of 
Information Act. This estimate will ordinarily be provided in terms of 
the approximate number of pages or some other reasonable measure. This 
estimate will not be provided if the volume of records denied is 
otherwise indicated through deletions on records disclosed in part. The 
letter will also include contact information for the Freedom of 
Information Act Public Liaison and the Office of Government Information 
Services.

0
11. In Sec.  20.61, revise paragraph (e)(2) to read as follows:


Sec.  20.61   Trade secrets and commercial or financial information 
which is privileged or confidential.

* * * * *
    (e) * * *
    (2) The submitter has 10 working days from the date of the notice 
to object to disclosure of any part of the records and to state all 
bases for its objections. The Division of Freedom of Information may 
extend this period as appropriate and necessary.
* * * * *

0
12. Revise Sec.  20.62 to read as follows:


Sec.  20.62   Inter- or intra-agency memoranda or letters.

    Interagency or intra-agency memoranda or letters that would not be 
available by law to a party other than an agency in litigation with the 
Food and Drug Administration may be withheld from public disclosure 
except that factual information that is reasonably segregable in 
accordance with the rule established in Sec.  20.22 is available for 
public disclosure. The deliberative process privilege shall not apply 
to records created 25 years or more before the date on which the 
records were requested.

0
13. In Sec.  20.82, revise paragraph (a) to read as follows:


Sec.  20.82   Discretionary disclosure by the Commissioner.

    (a) Except as provided in paragraph (b) of this section, the 
Commissioner may, in his or her discretion, disclose part or all of any 
Food and Drug Administration (FDA) record that is otherwise exempt from 
disclosure pursuant to subpart D of this part. As set forth in Sec.  
20.20(b), FDA will withhold requested information only if:
    (1) The Agency reasonably foresees that disclosure would harm an 
interest protected by an exemption described in this part; or
    (2) Disclosure is prohibited by law. FDA shall exercise its 
discretion to disclose such records whenever it determines that such 
disclosure is in the public interest, will promote the objectives of 
the Freedom of Information Act and the Agency, and is, for example, 
consistent with the rights of individuals to privacy, the property 
rights of persons in trade secrets, and the need for the Agency to 
promote frank internal policy deliberations and to pursue its 
regulatory activities without disruption.
* * * * *

0
14. Revise Sec.  20.85 to read as follows:


Sec.  20.85   Disclosure to other Federal Government departments and 
agencies.

    Any Food and Drug Administration (FDA) record otherwise exempt from 
public disclosure may be disclosed to other Federal Government 
departments and agencies, except that trade secrets and confidential 
commercial or financial information prohibited from disclosure by 21 
U.S.C. 331(j), 21 U.S.C. 360j(c), 21 U.S.C. 360ll(d), 21 U.S.C. 
360nn(e), and 21 U.S.C. 387f(c) may be released only as provided by 
those sections. Any disclosure under this section shall be pursuant to 
a written agreement that the record shall not be further disclosed by 
the other department or agency except with the written permission of 
FDA.

0
15. Revise Sec.  20.86 to read as follows:


Sec.  20.86   Disclosure in administrative or court proceedings.

    Data and information otherwise exempt from public disclosure may be 
revealed in Food and Drug Administration (FDA) administrative 
proceedings, such as those pursuant to parts 10, 12, 13, 14, 15, 17, 
and 19 of this chapter, or court proceedings, where data or information 
are relevant. FDA will take appropriate measures, or request that 
appropriate measures be taken, to reduce disclosure to the minimum 
necessary under the circumstances.

0
16. In Sec.  20.88, revise paragraphs (d)(1) introductory text, 
(d)(1)(i), (d)(1)(ii)(B) and (C), (d)(2), and (e)(1) and (3) to read as 
follows:


Sec.  20.88   Communications with State and local government officials.

* * * * *
    (d)(1) The Commissioner of Food and Drugs (or delegatee) may 
authorize the disclosure of confidential commercial information 
submitted to the Food and Drug Administration, or incorporated into 
Agency-prepared records, to State and local government officials as 
part of cooperative law enforcement or regulatory efforts, provided 
that:

[[Page 55914]]

    (i) The State or local government agency has provided both a 
written statement establishing its authority to protect confidential 
commercial information from public disclosure and a written commitment 
not to disclose any such information provided without the written 
permission of the sponsor or written confirmation by the Food and Drug 
Administration that the information no longer has confidential status; 
and
    (ii) * * *
    (B) Disclosure would be in the interest of public health by reason 
of the State or local government's possessing information concerning 
the safety, effectiveness, or quality of a product or information 
concerning an investigation, or by reason of the State or local 
government being able to exercise its regulatory authority more 
expeditiously than the Food and Drug Administration; or
    (C) The disclosure is to a State or local government scientist 
visiting the Food and Drug Administration on the Agency's premises as 
part of a joint review or long-term cooperative training effort 
authorized under section 708 of the Federal Food, Drug, and Cosmetic 
Act, the review is in the interest of public health, the Food and Drug 
Administration retains physical control over the information, the Food 
and Drug Administration requires the visiting State or local government 
scientist to sign a written commitment to protect the confidentiality 
of the information, and the visiting State or local government 
scientist provides a written assurance that he or she has no financial 
interest in the regulated industry of the type that would preclude 
participation in the review of the matter if the individual were 
subject to the conflict of interest rules applicable to the Food and 
Drug Administration advisory committee members under Sec.  14.80(b)(1) 
of this chapter. Subject to all the foregoing conditions, a visiting 
State or local government scientist may have access to trade secret 
information, entitled to protection under section 301(j) of the Federal 
Food, Drug, and Cosmetic Act, in those cases where such disclosures 
would be a necessary part of the joint review or training.
    (2) Except as provided under paragraph (d)(1)(ii)(C) of this 
section, the provisions of paragraph (d) of this section do not 
authorize the disclosure to State and local government officials of 
trade secret information concerning manufacturing methods and processes 
prohibited from disclosure by section 301(j) of the Federal Food, Drug, 
and Cosmetic Act, unless pursuant to an express written authorization 
provided by the submitter of the information.
* * * * *
    (e)(1) The Commissioner of Food and Drugs or (delegatee), may 
authorize the disclosure to, or receipt from, an official of a State or 
local government agency of nonpublic, predecisional documents 
concerning the Food and Drug Administration's or the other Government 
agency's regulations or other regulatory requirements, or other 
nonpublic information relevant to either agency's activities, as part 
of efforts to improve Federal-State and/or Federal-local uniformity, 
cooperative regulatory activities, or implementation of Federal-State 
and/or Federal-local agreements, provided that:
    (i) The State or local government agency has the authority to 
protect such nonpublic documents from public disclosure and will not 
disclose any such documents provided without the written confirmation 
by the Food and Drug Administration that the documents no longer have 
nonpublic status; and
    (ii) The Commissioner (or delegatee) makes the determination that 
the exchange is reasonably necessary to improve Federal-State and/or 
Federal-local uniformity, cooperative regulatory activities, or 
implementation of Federal-State and/or Federal-local agreements.
* * * * *
    (3) For purposes of paragraph (e) of this section, the term 
official of a State or local government agency includes, but is not 
limited to, an agent contracted by the State or local government, and 
an employee of an organization of State or local officials having 
responsibility to facilitate harmonization of State or local standards 
and requirements in the Food and Drug Administration's areas of 
responsibility. For such officials, the statement and commitment 
required by paragraph (e)(1)(i) of this section shall be provided by 
both the organization and the individual.

0
17. In Sec.  20.89, revise paragraphs (d)(1) introductory text and 
(d)(1)(ii) to read as follows:


Sec.  20.89   Communications with foreign government officials.

* * * * *
    (d)(1) The Commissioner of Food and Drugs (or delegatee) may 
authorize the disclosure to, or receipt from, an official of a foreign 
government agency of nonpublic, predecisional documents concerning the 
Food and Drug Administration's or the other Government agency's 
regulations or other regulatory requirements, or other nonpublic 
information relevant to either agency's activities, as part of 
cooperative efforts to facilitate global harmonization of regulatory 
requirements, cooperative regulatory activities, or implementation of 
international agreements, provided that:
* * * * *
    (ii) The Commissioner (or delegatee) makes the determination that 
the exchange is reasonably necessary to facilitate global harmonization 
of regulatory requirements, cooperative regulatory activities, or 
implementation of international agreements.
* * * * *

0
18. In Sec.  20.100:
0
a. Revise paragraph (c)(6);
0
b. Remove and reserve paragraphs (c)(20) and (21); and
0
c. Add paragraph (c)(48).
    The revision and addition read as follows:


Sec.  20.100   Applicability; cross-reference to other regulations.

* * * * *
    (c) * * *
    (6) Information on thermal processing of low-acid foods packaged in 
hermetically sealed containers, in Sec. Sec.  108.25(k) and 108.35(l) 
of this chapter.
* * * * *
    (48) Status reports of postmarketing study commitments in 
Sec. Sec.  314.81(b)(2)(vii)(b) and 601.70(e) of this chapter.

0
19. In Sec.  20.120, revise paragraph (a) to read as follows:


Sec.  20.120   Records available in Food and Drug Administration Public 
Reading Rooms.

    (a) The Freedom of Information Staff and the Dockets Management 
Staff Public Reading Room are located at the same address. Both are 
located in Rm. 1061, 5630 Fishers Lane, Rockville, MD 20852. The 
telephone number for the Docket Management Staff is 240-402-7500; the 
telephone number for the Freedom of Information Staff's Public Reading 
Room is located at the address on the Agency's website at https://www.fda.gov. Both public reading rooms are open from 9 a.m. to 4 p.m., 
Monday through Friday, excluding legal public holidays.
* * * * *

PART 720--VOLUNTARY FILING OF COSMETIC PRODUCT INGREDIENT 
COMPOSITION STATEMENTS

0
20. The authority citation for part 720 continues to read as follows:

    Authority:  21 U.S.C. 321, 331, 361, 362, 371, 374.

0
21. In Sec.  720.8, revise paragraphs (e) and (g) to read as follows:

[[Page 55915]]

Sec.  720.8   Confidentiality of statements.

* * * * *
    (e) If, after receiving all of the data that are necessary to make 
a determination about whether the identity of an ingredient is a trade 
secret, FDA tentatively decides to deny the request, the Agency will 
inform the person requesting trade secrecy of its tentative 
determination in writing. FDA will set forth the grounds upon which it 
relied in making this tentative determination. The petitioner may 
submit, within 60 days from the date of receipt of the written notice 
of the tentative denial, additional relevant information and arguments 
and request that the Agency reconsider its decision in light of both 
the additional material and the information that it originally 
submitted.
* * * * *
    (g) A final determination that an ingredient is not a trade secret 
within the meaning of Sec.  20.61 of this chapter constitutes final 
Agency action that is subject to judicial review under 5 U.S.C. Chapter 
7. If suit is brought within 30 calendar days after such a 
determination, FDA will not disclose the records involved or require 
that the disputed ingredient or ingredients be disclosed in labeling 
until the matter is finally determined in the courts. If suit is not 
brought within 30 calendar days after a final determination that an 
ingredient is not a trade secret within the meaning of Sec.  20.61 of 
this chapter, the records involved will be available for public 
disclosure in accordance with part 20 of this chapter.

    Dated: August 31, 2022.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2022-19736 Filed 9-12-22; 8:45 am]
BILLING CODE 4164-01-P


