Rule2022-19736
Public Information
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
September 13, 2022
Effective
October 13, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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[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 [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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, <a href="/cdn-cgi/l/email-protection#2d6b696c6b62646c6d4b494c0345455e034a425b"><span class="__cf_email__" data-cfemail="ce888a8f8881878f8ea8aaafe0a6a6bde0a9a1b8">[email protected]</span></a>.
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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> 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.
<bullet> The amendment to Sec. 20.44 updates the title of the
Agency official making determinations regarding requests for expedited
processing.
<bullet> 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.
<bullet> 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.
<bullet> 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).
<bullet> 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.
<bullet> 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.
<bullet> The amendment to 21 CFR 20.85 updates the statutory
references.
<bullet> The amendment to 21 CFR 20.86 clarifies that the list of
proceedings subject to the provision is not exclusive.
<bullet> 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.
<bullet> The amendments to 21 CFR 20.89 remove references to
position titles that no longer exist.
<bullet> The amendments to 21 CFR 20.100 update the regulatory
cross-references.
<bullet> The amendment to 21 CFR 20.120 updates the contact
information for the Agency's reading rooms.
<bullet> 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 <a href="https://www.fda.gov">https://www.fda.gov</a>. 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 <a href="https://www.fda.gov">https://www.fda.gov</a>.
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 <a href="https://www.fda.gov">https://www.fda.gov</a>, by faxing it to the fax number listed on the Agency's
website at <a href="https://www.fda.gov">https://www.fda.gov</a>, or by submission through the Agency's
online FOIA submission portal at <a href="https://www.fda.gov">https://www.fda.gov</a>. 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 <a href="https://www.fda.gov">https://www.fda.gov</a>. 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
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</html>Indexed from Federal Register on September 13, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.