[Federal Register Volume 88, Number 177 (Thursday, September 14, 2023)]
[Rules and Regulations]
[Pages 63020-63031]
[FR Doc No: 2023-19699]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 2

[OGC-2022-0885; FRL 5630-01-OGC]
RIN 2025-AA38

Freedom of Information Act Regulations Update; Phase II

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA or Agency) finalizes
revisions to the Agency's regulations under the Freedom of Information
Act (FOIA or Act). This action supports the Agency's mission by
updating the process by which the public may access information about
EPA actions and activities.

DATES: This rule is effective on November 13, 2023.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. OGC-2022-0885. All documents in the docket are listed on
the http://www.regulations.gov website. Although listed in the index,
some information is not publicly available, e.g., CBI or other
information whose disclosure is restricted by statute. Certain other
material, such as copyrighted material, is not placed on the internet
and will be publicly available only in hard copy form. Publicly
available docket materials are available electronically through http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Christopher T. Creech, Office of
General Counsel, U.S. Environmental Protection Agency, 1200
Pennsylvania Avenue NW, (2310A), Washington, DC 20460; telephone, 202-
564-4286; email, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. General Information
II. Background
III. Summary of Provisions Finalized as Proposed
IV. Summary of Changes From Proposal
V. Statutory and Executive Orders Reviews

I. General Information

A. Does this action apply to me?

    This discussion is not intended to be exhaustive, but rather
provides a guide for readers regarding entities likely to be regulated
by this action. This discussion includes the types of entities that EPA
is now aware could potentially be regulated by this action. Other types
of entities not included could also be regulated. To determine whether
your entity is regulated by this action, you should carefully examine
the applicability criteria found in 40 CFR part 2. If you have
questions regarding the applicability of this action to a particular
entity, consult the person listed in the FOR FURTHER INFORMATION
CONTACT section.

B. What action is the Agency taking?

    This action finalizes changes to EPA's FOIA regulations at 40 CFR
part 2. The changes alter the process by which individuals and entities
request records from EPA under the Act. EPA makes changes to clarify
certain provisions and align with the FOIA and with EPA and government-
wide policy.
    In the 2019 ``Freedom of Information Act Regulations Update,'' 84
FR 30028, July 26, 2019 (Phase I Rule), EPA stated its intention to
conduct a second rulemaking phase to make discretionary and modernizing
changes. Consistent with that statement, EPA is finalizing the proposal
published on November 17. 2022 with certain changes. See

Freedom of Information Act Regulations Update; Phase II, 87 FR 68946.

II. Background

    This action is the second phase in a two-phase process to update
the Agency's FOIA regulations. On June 26, 2019, effective July 26,
2019, EPA issued the Phase I Rule to ``bring EPA's regulations into
compliance with nondiscretionary provisions of the amended statute and
reflect changes in the Agency's organization, procedure, or practice.''
84 FR 30028.

III. Summary of Provisions Finalized as Proposed

    Below is a summary of the provisions that EPA finalizes in the same
form that they were proposed.

A. Time for Response to Modification Request

    EPA adds a statement that requires a requester to modify a request
within 20 calendar days after an EPA notice that the request is not
reasonably described. 40 CFR 2.102(c) requires that requesters
reasonably describe the records that they are seeking. EPA did, and
continues to, provide requesters with an opportunity to discuss and
modify a request that does not reasonably describe the records sought.
Previously, however, there was no clear timeline for requesters to
modify a request. If a requester sufficiently modifies the request to
meet the requirements of 40 CFR 2.102(c) within 20 calendar days, EPA
will not close the request.

B. Readability and Useful Information

    EPA reorganizes, but makes no substantive changes to, 40 CFR
2.100(a) by moving to separate paragraphs the sentences describing
other regulations relevant to the release of information.
    EPA creates a new paragraph (f) in section 2.100 to direct the
public to the Agency's website (epa.gov/foia) for records made publicly
available in compliance with 5 U.S.C. 522(a)(2)(D)(ii)(II).
    EPA consolidates the provisions in EPA's FOIA regulations that
discuss the timing of EPA's response to FOIA requests to simplify and
accurately represent EPA's obligations under the FOIA. This change
combines into section 2.104(a) previous sections 2.101(a)(4) and
2.102(a), and directly incorporates into section 2.104(a) the FOIA's
language on timing of response from 5 U.S.C. 552(a)(6)(A)(i). EPA also
explains at section 2.104(f) that EPA will work with requesters to come
to an agreement regarding alternative timeframes for processing the
request when EPA provides notice pursuant to 5 U.S.C. 552(a)(6)(B)(i)
and (ii).
    EPA adds to section 2.104(a)(2) providing that a request submitted
after 5:00 p.m. Eastern Time is considered received on the next
business day. This change states the corollary of the already existing
and unchanged language stating that requests submitted before 5:00 p.m.
are considered received on that business day. EPA modifies section
2.108(b) to state that appeals submitted after 5:00 p.m. Eastern Time
are considered received on the next business day.

C. Consistency With Government-Wide Policy

    EPA makes three changes, found at sections 2.106, 2.108(d)(3), and
2.108(e)(1), which discuss the preservation of records, handling of
appeals after FOIA litigation, and the contents of adverse
administrative appeals decisions.
    EPA updates 40 CFR 2.107(b) to state that payments by check or
money order should be made out to the Treasury of the United States.
    EPA revises all references to EPA's electronic submission website,
FOIAonline (www.FOIAonline.gov), to a more general location, EPA's FOIA
website (www.epa.gov/foia). EPA will identify for requesters the
electronic submission platform's new link on EPA's FOIA website.

D. 2019 Phase I Regulations

    EPA removes the clause in 40 CFR 2.103(b) that described the phrase
``determinations required by 5 U.S.C. 552(a)(6)(A).'' 40 CFR 2.103(b)
previously stated ``[Listed positions within EPA] are authorized to
make determinations required by 5 U.S.C. 522(a)(6)(A), including to
issue final determinations whether to release or withhold a record or a
portion of a record on the basis of responsiveness or under one or more
of the exemptions under the FOIA, and to issue `no records'
responses.'' 40 CFR 2.103(b) now states that ``[Listed positions within
EPA] are authorized to make determinations required by 5 U.S.C.
522(a)(6)(A).''
    EPA does not reinstate any methods of submission that EPA removed
through the issuance of the 2019 FOIA Regulations Update. See 2019 FOIA
Regulations Update, 84 FR 30028 at 30030, July 26, 2019. EPA continues
to accept FOIA requests through its FOIA submission website, an
electronic submission website established pursuant to 5 U.S.C. 552(m),
and U.S. Mail and overnight delivery sent to the National FOIA Office.

E. General Processing Changes

    EPA changes the ``ordinary'' search cut-off date identified in
section 2.103(a) from the date the request was received to the date the
Agency begins its search for responsive records.
    EPA adds a provision at 40 CFR 2.107(l) that states EPA may
aggregate FOIA requests when EPA reasonably believes that multiple
requests--submitted either by a requester or by a group of requesters
acting in concert--constitute a single request that would otherwise
give rise to unusual circumstances and the requests involve related
matters.
    EPA adds a provision at 40 CFR 2.104(f) that states EPA may assign
multiple tracking numbers to a request with distinct parts that will be
processed by separate regions or program offices. EPA will notify the
requester of the separate tracking numbers for the distinct parts of
the request, which thereafter would be processed and responded to
separately and will be provided with separate appeal rights on
completion.
    EPA modifies the methods of submission of FOIA appeals, located at
section 2.108(a), to match the methods of submission of FOIA requests.

F. Fee Rates Update

    EPA establishes new fee rates, located at 40 CFR 2.107(f)(2)(ii)
tied to the U.S. Office of Personnel and Management's General Schedule
(GS) scale. EPA now has two fee rates for Agency personnel time spent
processing FOIA requests, one rate for grades GS-12 and below and a
second rate for those with grades GS-13 and above. Both rates are
adjusted for the value of benefits, expressed in quarter-hour rates,
and rounded to the nearest $1 increment. As of the date of signature,
the proposed rates would be calculated as explained below.
Employees GS-12 and Below
Average Quarter-Hour Rate of GS-9 Step 1, GS-10 Step 1, GS-11 Step 1,
and GS-12 Step 1 ($8.83) + Benefits (16% or $1.41) = $10.25 = (rounded
to the nearest $1 increment) $10.00/quarter hour
Employees GS-13 and Above
Average Quarter-Hour Rate for GS-13 Step 1, GS-14 Step 1, and GS-15
Step 1 ($15.24) + Benefits (16% or $2.43) = $17.67 = (rounded to the
nearest $1 increment) $18.00/quarter-hour

G. Minimum Fee Threshold

    EPA increases the minimum fee threshold, located at 40 CFR
2.107(g)(1), to an amount calculated by formula,

which, as of the publication of this rule is $250. That formula would
apply a fourteen (14) times multiplier to the rate set in 40 CFR
2.107(e)(2)(ii)(B), rounded to the nearest $5 increment. As of the date
of signature, the minimum fee threshold would be calculated as
explained below.

Fee rate listed in 40 CFR 2.107(f)(2)(ii)(B) ($18.00) x 14 = $252 =
(rounded to the nearest $5 increment) $250

H. Automatic Agreement To Pay Fees

    EPA removes the provision specifying that a requester automatically
agrees to pay up to $25 in fees when they submit a FOIA request.
Because EPA raises the minimum fee threshold, EPA believes that an
automatic agreement to fees at any amount at or above $250 may dissuade
some requesters from submitting FOIA requests.

I. Assurance of Payment Threshold

    EPA raises the assurance of payment threshold, located at 40 CFR
2.107(h)(1), to an amount calculated by formula, which, as of the
publication of this rule is $250. When EPA estimates fees or
accumulates actual fees equaling or exceeding the assurance of payment
threshold, EPA seeks from a requester an assurance that the requester
will pay the fees associated with the FOIA request. The formula would
tie the assurance of payment threshold to the minimum fee threshold (40
CFR 2.107(g)(1)).

J. Advanced Payment Threshold

    EPA increases the advanced payment threshold, located at 40 CFR
2.107(h)(2), to an amount that would currently calculate to $450 and
proposes a formula for calculating the advance payment threshold that
will be self-escalating as EPA's costs increase in future years. When
EPA estimates fees or accumulates actual fees equaling or exceeding the
advanced payment threshold, EPA may seek advanced payment from a
requester of the estimated or actual fees associated with the FOIA
request.

Fee rate listed in proposed 40 CFR 2.107(f)(2)(ii)(B) ($18.00) x 25 =
$450

K. Estimated or Actual Fee Assessment

    EPA adds language at 2.107(h)(5) explaining that EPA's reassessment
of actual or estimated fees may result in EPA re-seeking assurance of
payment or advanced payment. This provision provides clarity and
informs the public regarding EPA's practices by describing a scenario
where EPA has previously informed the requester of the amount of actual
or estimated fees and, after further processing, EPA has updated its
actual or estimated fee assessment.

L. Failure To Pay Charged Fees

    EPA revises the provisions applicable to delinquent requesters.
Previous EPA regulations discussed the failure to pay fees in several
separate locations (previous sections 2.107(h) and (j). EPA
consolidates these provisions into 40 CFR 2.107(k). EPA also adds a
sentence stating that the Agency may share information regarding
delinquent requesters with other Federal agencies.

IV. Summary of Changes From Proposal

    Below is a summary of the changes from what EPA proposed and what
EPA finalizes today.

A. Environmental Justice Expedited Processing Criteria

    EPA proposed, and here finalizes, a provision to allow requesters
to seek expedited processing of their request if the records sought
pertain to an environmental justice-related need and will be used to
inform an affected community. 5 U.S.C. 552(a)(6)(E)(i) provides that
EPA may issue regulations ``providing for expedited processing of
requests for records (I) in cases in which the person requesting the
records demonstrates a compelling need; and (II) in other cases
determined by the agency.'' (emphasis added). The Act defines what
constitutes a ``compelling need,'' id. at section 552(a)(6)(E)(v), and
does not limit the ``other cases'' that the Agency may determine merit
expedited processing.
    EPA finalizes the proposed provision with two minor changes. EPA
makes the first change to reflect a change in relevant descriptive
language used in Executive Order 14096. EPA modifies the phrase
``disproportionately high and adverse human health or environmental
effects'' to read ``disproportionate and adverse human health or
environment effects.'' This change will ensure consistency with EPA
policy but is not intended to have substantive impact on EPA's
implementation on the environmental justice-need expedited processing
provision.
    EPA makes the second change to improve the readability of the
environmental justice expedited processing criteria. EPA reorganizes
but does not substantively change 40 CFR 2.107(g)(ii). As proposed, the
provision specified considerations in both 2.107(g)(ii) and in the
subsequent subparagraphs. The reorganization identifies in a list
format the specific elements EPA will consider. EPA believes that this
change is clearer than the proposal and will benefit requesters by
providing a set of elements that flow in a logical and express manner.
    The provision providing expedited processing for an environmental
justice-related need is in addition to and does not modify the
provision granting expedited processing for requests demonstrating a
``compelling need,'' which the FOIA provides at 5 U.S.C.
552(a)(6)(E)(i)(I). This new expedited processing category targets a
recognized need for communities with environmental justice concerns to
have timely access to information.
    Executive Order 14096 defines environmental justice as ``the just
treatment and meaningful involvement of all people, regardless of
income, race, color, national origin, Tribal affiliation, or
disability, in agency decision-making and other Federal activities that
affect human health and the environment[.]'' EPA recognizes that timely
access to information contained in EPA records improves the opportunity
for meaningful involvement by communities with environmental justice
concerns.
    To determine whether an application for expedited processing
qualifies under this provision, the Agency will consider: (1) whether
the requested records relate to actual or alleged Federal government
activity, including Agency records containing environmental information
or data; (2) the extent to which there is a pressing need to inform the
community about the Federal government activity; (3) the extent to
which the community is potentially experiencing disproportionate and
adverse human health or environmental effects; and (4) the requester's
ability and intention to effectively convey the information to members
of the community.
    EPA will use EJScreen as a source of facts to determine whether the
community cited by the requester is potentially experiencing
environmental justice concerns. As EPA previously explained in the
preamble to the proposed rule, EJScreen is an environmental justice
mapping and screening tool that provides EPA with a nationally
consistent dataset and approach for combining environmental and
demographic indicators into Environmental Justice indexes. EJScreen's
``Supplemental Indexes'' are thirteen indexes calculated by combing a
single environmental indicator and the supplemental demographic index.
The Supplemental Indexes do not factor in racial status. EJScreen may
also be a valuable tool for requesters to assess whether the community
about which they are seeking records may be affected

by disproportionate and adverse human health or environmental effects.
More information regarding EJScreen is available at this link: https://www.epa.gov/ejscreen/environmental-justice-indexes-ejscreen. EPA notes
that it will consider additional information the requester provides if
the additional information is not adequately reflected in the methods
and tools available to the Agency, like EJScreen's Supplemental
Indexes, and the Agency is not otherwise prohibited from considering
the information.
    One commenter suggested that EPA ``make[ ] clear that any criteria
be applied flexibly and generously to accomplish the goals of this
provision.'' EPA acknowledges the commenter's concern and will
implement the provision consistent with the regulatory text. As such,
EPA provides the following examples of types of requests that EPA would
consider as evidencing a pressing need to inform a community
potentially experiencing environmental justice-related concerns.

--Requests for EPA-held data or communications that are reasonably
likely to contain information that is directly relevant to an
environmental harm affecting a community potentially experiencing
environmental justice-related concerns.
--Requests for information about or relevant to an action or policy,
existing or in development, that is reasonably likely to have a direct,
imminent, and cognizable connection to a threat to human health in a
community experiencing environmental justice-related concerns.

    On the other hand, EPA would not consider the following types of
requests to show a pressing need to inform the community.

--Requests for information about a nation-wide action or policy, either
existing or in development, that is largely only of general interest to
the public.
--Requests for environmental data without a direct and cognizable
connection to the community.
--Requests for information that is primarily in the commercial interest
of the requester.
--Requests for communications which are not reasonably likely to
contain information related to the community.
--Requests for wholly publicly available information.
--Requests for information about an environmental concern not affecting
or not reasonably likely to affect the community.

    One commenter suggested that EPA remove the evaluation criteria
regarding the requester's intent and ability to effectively convey the
information to members of the community that is potentially
experiencing disproportionate and adverse human health or environmental
effects. EPA declines to make this change. The purpose of considering
the requesters intent and ability to effectively convey the information
to members of the community is to ensure that those seeking the
information can and are likely to meet the information needs of members
of the community. EPA believes that this consideration is essential to
both the purpose and effective implementation of the provision.
    For clarity on how EPA intends to implement the ``ability and
intention'' element, EPA provides the following examples that EPA would
consider as evidencing an ability and intent to inform the community
potentially experiencing environmental justice-related concerns:

--The requester is a membership or community-based organization with
active members in the community and that disseminates environmental- or
health-related information to those members.
--The requester is a news organization with active subscribers in the
community and that disseminates environmental- or health-related
information to those subscribers.
--The requester has demonstrated a particular technical expertise in
the subject area and has previously directly disseminated information
to the community or similar communities.

    EPA would consider the following types of requests to not show an
intent and ability to inform the community potentially experiencing
environmental justice-related concerns:

--The requester's stated ability to disseminate the information to the
community is limited to passive or indirect means (e.g., dissemination
through a website, newsletter, or other publication without indication
of directly reaching members of the community).
--A requester without either a direct connection to the community or a
demonstrated expertise in the subject matter.
--A requester without a direct connection to the community and without
a mission and history of disseminating information to the community.
--The Agency may consider previous failures to disseminate to the
community information a requester received from EPA through an
expedited request for records.

B. Definition of Reasonably Described Requests

    EPA proposed modifying previous section 2.102(c) to state that
``Requesters should reasonably describe the records sought in
sufficient detail to enable agency personnel to locate them with a
reasonable amount of effort.'' One commenter suggested to use
alternative language from Truitt v. Department of State. See 897 F.2d
540 (D.C. Cir. 1990). EPA agrees with the comment and changes the
sentence, which is now located at section 2.102(b)(1), to state that
``Requesters must reasonably describe the records sought in sufficient
detail to enable a professional employee of the agency who is familiar
with the subject area of the request to locate the records with
reasonable amount of effort.'' See Truitt v. Dep't of State, 897 F.2d
540, 545 n.36 (D.C. Cir. 1990), quoting H.R. Rep. No. 93-876, 93d
Cong., 2d Sess. 5-6 (1974).

C. Requests for Waiver and Reduction of Fees

    EPA proposed to incorporate a requirement that a requester must
submit a statement, certified to be true and correct to the best of the
requester's knowledge and belief, explaining in detail the basis for
the fee waiver request. EPA does not finalize that proposed provision
at this time.

D. Language Referring to Appeal Letter

    EPA received one comment about the use of the term ``appeal
letter'' in the section of the regulations discussing administrative
appeals, 40 CFR 2.108. The comment stated that the use of the word
``letter'' was misleading and implied that physical mail is suggested
or preferred for purposes of appeal. Dropping the term ``letter'' would
provide clarity to requesters. EPA reviewed the use of the word
``letter'' and related terms and updated 40 CFR 2.108(c). These changes
have no substantive impact on EPA or the public and are meant solely
for clarity.

E. Grammatical Edit

    EPA received one comment noting that the hyphen is not needed in
the phrase ``90-calendar days'' and should be removed. EPA agrees with
the commentor will make the suggested change at 40 CFR 2.108(a).

V. Statutory and Executive Orders Reviews

    Additional information about these statutes and Executive Orders
can be found at https://www.epa.gov/laws-regulations/laws-and-executive-orders.

A. Executive Order 12866: Regulatory Planning and Review and Executive
Order 13563: Improving Regulation and Regulatory Review

    This action is not a significant regulatory action and was
therefore not submitted to the Office of Management and Budget (OMB)
for review.

B. Paperwork Reduction Act (PRA)

    This action does not impose an information collection burden under
the PRA.

C. Regulatory Flexibility Act (RFA)

    I certify that this action will not have a significant economic
impact on a substantial number of small entities under the RFA. In
making this determination, EPA concludes that the impact of concern for
this rule is any significant adverse economic impact on small entities
and that the agency is certifying that this rule will not have a
significant economic impact on a substantial number of small entities
because the rule has no net burden on the small entities subject to the
rule. This final rule does not impose any new requirements on small
entities, and the EPA FOIA regulation's requirements apply equally to
all FOIA requesters. This rule raises the FOIA fee rates, which EPA
applies when EPA charges for the direct costs of EPA staff's time. This
change does not represent a significant economic impact and any impact
will be offset by increasing the minimum fee threshold. If EPA does not
accumulate chargeable fees in an amount above the minimum fee
threshold, then EPA does not charge fees. We have therefore concluded
that this action will have no net regulatory burden for all directly
regulated small entities.

D. Unfunded Mandates Reform Act (UMRA)

    This action does not contain any unfunded mandates as described in
UMRA, 2 U.S.C. 1531-1538, and does not significantly or uniquely affect
small governments. The action imposes no enforceable duty on any state,
local or tribal governments or the private sector.

E. Executive Order 13132: Federalism

    This action does not have federalism implications. It will not 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.

F. Executive Order 13175: Consultation and Coordination With Indian
Tribal Governments

    This action does not have tribal implications as specified in
Executive Order 13175. It will not have substantial direct effects on
Indian Tribal governments or on the relationship between the national
government and the Indian Tribal governments. Thus, Executive Order
13175 does not apply to this action.

G. Executive Order 13045: Protection of Children From Environmental
Health and Safety Risks

    The EPA interprets Executive Order 13045 as applying only to those
regulatory actions that concern environmental health or safety risks
that EPA has reason to believe may disproportionately affect children,
per the definition of ``covered regulatory action'' in section 2-202 of
the Executive order. This action is not subject to Executive Order
13045 because it does not concern an environmental health risk or
safety risk.

H. Executive Order 13211: Actions Concerning Regulations That
Significantly Affect Energy Supply, Distribution or Use

    This action is not subject to Executive Order 13211 because it is
not a significant regulatory action under Executive Order 12866.

I. National Technology Transfer and Advancement Act

    This rule does not involve technical standards.

J. Executive Order 12898: Federal Actions To Address Environmental
Justice in Minority Populations and Low-Income Populations

    Executive Order 12898 (59 FR 7629, February 16, 1994) directs
Federal agencies, to the greatest extent practicable and permitted by
law, to make environmental justice part of their mission by identifying
and addressing, as appropriate, disproportionately high and adverse
human health or environmental effects of their programs, policies, and
activities on minority populations (people of color) and low-income
populations.
    The EPA believes that this type of action does not concern human
health or environmental conditions and therefore cannot be evaluated
with respect to potentially disproportionate and adverse effects on
people of color, low-income populations and/or indigenous peoples.
Although this action does not concern human health or environmental
conditions, the EPA identifies and addresses environmental justice
concerns by finalizing a provision to allow requesters to seek
expedited processing of their request if the records sought pertain to
an environmental justice-related need and will be used to inform an
affected community. See section IV.A. of this preamble.

K. Congressional Review Act (CRA)

    This action is subject to the CRA, and the EPA will submit a rule
report to each House of the Congress and to the Comptroller General of
the United States. This action is not a ``major rule'' as defined by 5
U.S.C. 804(2).

List of Subjects in 40 CFR Part 2

    Environmental protection, Administrative practice and procedure,
Confidential business information, Freedom of information, Government
employees.

Michael S. Regan,
Administrator.

    For the reasons set forth in the preamble, the EPA amends title 40
of the Code of Federal Regulations, part 2 as follows:

PART 2--PUBLIC INFORMATION

0
1. The authority citation for part 2 continues to read as follows:

    Authority:  5 U.S.C. 552, 552a, 553; 28 U.S.C. 509, 510, 534; 31
U.S.C. 3717.

0
2. Subpart A of Part 2 is revised to read as follows:

PART 2--PUBLIC INFORMATION

Subpart A--Procedures for Disclosure of Records Under the Freedom of
Information Act
Sec.
2.100 General provisions.
2.101 Where to file requests for records.
2.102 Procedures for making requests.
2.103 Responsibility for responding to requests.
2.104 Responses to requests.
2.105 [Reserved]
2.106 Preservation of records.
2.107 Fees.
2.108 Administrative appeals.
2.109 Other rights and services.

Subpart A--Procedures for Disclosure of Records Under the Freedom
of Information Act

Sec.  2.100  General provisions.

    (a) General. This subpart contains the rules that the Environmental
Protection

Agency (EPA or Agency) follows in processing requests for records under
the Freedom of Information Act (FOIA), 5 U.S.C. 552. Information
routinely provided to the public as part of a regular EPA activity may
be provided to the public without following this subpart.
    (b) Other regulatory provisions. (1) Subpart B of this part
contains requirements pertaining to the confidentiality of business
information.
    (2) 40 CFR part 16 contains requirements pertaining to Privacy Act
requests.
    (c) Statutory-based fee schedule programs. EPA will inform the
requester of the steps necessary to obtain records from agencies
operating statutory-based fee schedule programs, such as, but not
limited to, the Government Printing Office or the National Technical
Information Service.
    (d) National FOIA Office. The Chief FOIA Officer designates the
office that performs the duties of the National FOIA Office. The
National FOIA Office reports to the Chief FOIA Officer.
    (e) FOIA Public Liaison. The Chief FOIA Officer designates the FOIA
Public Liaisons. The FOIA Public Liaisons report to the Chief FOIA
Officer. A FOIA Public Liaison is responsible for assisting in reducing
delays, increasing transparency and understanding of the status of
requests, and assisting in the resolution of disputes. A FOIA Public
Liaison is an official to whom a requester can raise concerns about the
service the requester received from the FOIA Requester Service Center.
The public can find more information about the FOIA Public Liaisons at
EPA's website.
    (f) Other record availability. Records required by FOIA to be made
available for public inspection and copying are accessible through
EPA's FOIA website, http://www.epa.gov/foia. EPA also proactively
discloses records and information through the Agency's website,
www.epa.gov.

Sec.  2.101  Where to file requests for records.

    (a) Requesters must submit all requests for records from EPA under
the FOIA in writing and by one of the following methods:
    (1) EPA's FOIA submission website, linked to at www.epa.gov/foia;
    (2) An electronic government submission website established
pursuant to 5 U.S.C. 552(m), such as FOIA.gov;
    (3) U.S. Mail sent to the following address: National FOIA Office,
U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW
(2310A), Washington, DC 20460; or
    (4) Overnight delivery service to National FOIA Office, U.S.
Environmental Protection Agency, 1200 Pennsylvania NW, Room 7309C,
Washington, DC 20460.
    (b) EPA will not treat a request submitted by any method other than
those listed in Sec.  2.101(a) as a FOIA request, and the Agency will
not re-route such a request.
    (c) The requester or requester organization must include the full
name of their point of contact and their mailing address for EPA to
process the request. For all requests, requesters should provide an
email address and daytime telephone number whenever possible. For
requests submitted through EPA's FOIA submission website or as provided
by an electronic government submission website established pursuant to
5 U.S.C. 552(m), requesters must include an email address. For requests
submitted through U.S. Mail, the requester must mark both the request
letter and envelope ``Freedom of Information Act Request.''
    (d) EPA provides access to all records that the FOIA requires an
agency to make regularly available for public inspection and copying.
Each office is responsible for determining which of the records it
generates are required to be made publicly available and for providing
access by the public to them. The Agency will also maintain and make
available for public inspection and copying a current subject matter
index of such records and provide a copy or a link to the respective
website for Headquarters or the Regions. Each index will be updated
regularly, at least quarterly, with respect to newly-included records.
    (e) All records created by EPA on or after November 1, 1996, which
the FOIA requires an agency to make regularly available for public
inspection and copying, will be made available electronically through
EPA's website, located at http://www.epa.gov, or, upon request, through
other electronic means. EPA will also include on its website the
current subject matter index of all such records.

Sec.  2.102  Procedures for making requests.

    (a) EPA employees may attempt in good faith to comply with oral
requests for inspection or disclosure of EPA records that are publicly
available under Sec.  2.201(a) and (b), but such requests are not
subject to the FOIA or this Part.
    (b)(1) Requesters must reasonably describe the records sought in
sufficient detail to enable a professional employee of the Agency who
is familiar with the subject area of the request to locate the records
with a reasonable amount of effort.
    (2) If EPA determines that a request does not reasonably describe
the requested records as provided in Sec.  2.102(b)(1), EPA will tell
the requester either what additional information the requester needs to
provide or why the request is otherwise insufficient. EPA will also
give the requester an opportunity to discuss and modify the request to
meet the requirements of Sec.  2.102(b)(1). If the requester fails to
modify the request to meet the requirements of Sec.  2.102(b)(1) within
20 calendar days, EPA will not process the submission and close the
request. If the requester does modify the request to meet the
requirements of Sec.  2.102(b)(1), EPA will consider the request
received as of the date the modification is received by EPA.
    (3) Whenever possible, a request should include specific
information about each record sought, such as the date, title or name,
author, recipient, and subject matter. If known, the requester should
include any file designations or descriptions for the records that the
requester wants. The more specific the requester is about the records
or type of records that the requester wants, the more likely EPA will
be able to identify and locate records responsive to the request.

Sec.  2.103  Responsibility for responding to requests.

    (a) In general. Upon receipt of a FOIA request under Sec.
2.101(a), the National FOIA Office will assign the request to an
appropriate office within the Agency for processing. To determine which
records are within the scope of a request, an office will ordinarily
include only those records in the Agency's possession as of the date
that the Agency begins its search. The Agency will inform the requester
if any other date is used.
    (b) Authority to issue final determinations. The Administrator,
Deputy Administrators, Assistant Administrators, Deputy Assistant
Administrators, Regional Administrators, Deputy Regional
Administrators, General Counsel, Deputy General Counsels, Regional
Counsels, Deputy Regional Counsels, and Inspector General or those
individuals' delegates, are authorized to make determinations required
by 5 U.S.C. 552(a)(6)(A).
    (c) Authority to grant or deny fee waivers or requests for
expedited processing. EPA's Chief FOIA Officer or EPA's Chief FOIA
Officer's delegates are authorized to grant or deny requests for fee
waivers or requests for expedited processing.

    (d) Consultations and referrals. When a request to EPA seeks
records in EPA's possession that originated with another Federal
agency, the EPA office assigned to process the request shall either:
    (1) In coordination with the National FOIA Office, consult with the
Federal agency where the record or portion thereof originated and then
respond to the request, or
    (2) With the concurrence of the National FOIA Office, refer any
record to the Federal agency where the record or portion thereof
originated. The National FOIA Office will notify the requester whenever
all or any part of the responsibility for responding to a request has
been referred to another agency.
    (e) Law enforcement information. Whenever a requester makes a
request for a record containing information that relates to an
investigation of a possible violation of law and the investigation
originated with another agency, the assigned office, with the
concurrence of the National FOIA Office, will refer the record to that
other agency or consult with that other agency prior to making any
release determination.
    (f) Assigning tracking numbers. EPA may assign multiple tracking
numbers to a FOIA request that contains unrelated parts that will be
processed separately by multiple regions or headquarters program
offices.

Sec.  2.104  Responses to requests.

    (a) Timing of response. (1) Consistent with 5 U.S.C. 552(a)(6)(A)
and upon any request for records made pursuant to this subpart, EPA
shall determine within 20 working days after receipt of any such
request whether to comply with such request and shall immediately
notify the person according to this section.
    (2) A requester submitting a request electronically must do so
before 5:00 p.m. Eastern Time for the Agency to consider the request as
received on that date, and a request submitted electronically at or
after 5 p.m. Eastern Time will be considered received by the National
FOIA Office on the next business day.
    (3) The timeframe for response may be extended if unusual
circumstances exist per paragraph (f) of this section, including when
EPA asserts unusual circumstances and arranges an alternative timeframe
with the requester, or exceptional circumstances exist per paragraph
(g) of this section. The timeframe for response may be tolled per
paragraph (e) of this section.
    (b) Agency failure to respond. If EPA fails to respond to the
request within the statutory time-period, or any authorized extension
of time, the requester may seek judicial review to obtain the records
without first making an administrative appeal.
    (c) Acknowledgment of request. On receipt of a request, the
National FOIA Office ordinarily will send a written acknowledgment
advising the requester of the date the Agency received the request and
of the processing number assigned to the request for future reference.
    (d) Multitrack processing. The Agency uses three or more processing
tracks by distinguishing between simple and complex requests based on
the amount of work, time needed to process the request, or both,
including limits based on the number of pages involved. The Agency will
advise the requester of the processing track in which the Agency placed
the request and the limits of the different processing tracks. The
Agency may place the request in a slower track while providing the
requester with the opportunity to limit the scope of the request to
qualify for faster processing within the specified limits of a faster
track. If the Agency places the request in a slower track, the Agency
will contact the requester.
    (e) Tolling the request. EPA shall not toll the processing time-
period except:
    (1) The Agency may toll the processing time-period one time while
seeking clarification from the requester; or
    (2) The Agency may toll the processing time-period as many times as
necessary to resolve fee issues.
    (f) Unusual circumstances. (1) When the Agency cannot meet
statutory time limits for processing a request because of ``unusual
circumstances,'' as defined in the FOIA, and the time limits are
extended on that basis, the Agency will notify the requester in
writing, as soon as practicable, of the unusual circumstances and of
the date by which processing of the request should be completed.
    (2) If the 20 working-day period is extended, EPA will give the
requester an opportunity to limit the scope of the request, modify the
request, or agree to an alternative time-period for processing, as
described by the FOIA.
    (3) EPA will provide contact information for its FOIA Public
Liaison to assist in the resolution of any disputes between the
requester and the Agency, and the Agency will notify the requester of
their right to seek dispute resolution services from the Office of
Government Information Services within the National Archives and
Records Administration.
    (g) Expedited processing. (1) EPA will take requests or appeals out
of order and give expedited treatment whenever EPA determines that such
requests or appeals involve a compelling need, an environmental
justice-related need, or both.
    (i) A compelling need is defined as either:
    (A) Circumstances in which the lack of expedited treatment could
reasonably be expected to pose an imminent threat to the life or
physical safety of an individual; or
    (B) An urgency to inform the public about an actual or alleged
Federal government activity, if the information is requested by a
person primarily engaged in disseminating information to the public.
    (ii) For purposes of this provision, an environmental justice-
related need means a pressing need to inform a community that is
potentially experiencing disproportionate and adverse human health or
environmental effects. The Agency will consider:
    (A) Whether the requested records relate to actual or alleged
Federal government activity, including Agency records containing
environmental information or data.
    (B) The extent to which there is a pressing need to inform the
community about the Federal government activity. A pressing need to
inform does not include requests where the disclosure is primarily in
the commercial interest of the requester.
    (C) The extent to which the community is potentially experiencing
disproportionate and adverse human health or environmental effects.
    (D) The requester's ability and intention to effectively convey the
information to members of the community.
    (iii) If the Agency grants a request for expedited processing under
paragraph (g)(1)(ii) of this section, the Agency will also waive fees
established under Sec.  2.107(f) for the request.
    (2) Requesters must make a written request for expedited processing
at the time of the initial request for records or at the time of
appeal.
    (3) If the requester seeks expedited processing, the requester must
submit a statement, certified to be true and correct to the best of the
requester's knowledge and belief, explaining in detail the basis for
the request.
    (i) For example, if the requester fits within the category
described in paragraph (g)(1)(i)(B) of this section and is not a full-
time member of the news media, the requester must establish that they
are a person whose primary professional activity or occupation is
information dissemination, although it

need not be the requester's sole occupation.
    (ii) If the requester fits within the category described in
paragraph (g)(1)(i)(B) of this section, the requester must also
establish a particular urgency to inform the public about the
government activity involved in the request, beyond the public's right
to know about government activity generally.
    (4) Within 10 calendar days from the date of the request for
expedited processing, the Chief FOIA Officer, or the Chief FOIA
Officer's delegates, will decide whether to grant the request and will
notify the requester of the decision. If the Agency grants the request
for expedited processing, the Agency will give the request priority and
will process the request as soon as practicable. If the Agency denies
the request for expedited processing, the Agency will act on any appeal
of that decision expeditiously.
    (h) Grants of requests. Once the Agency determines to grant a
request in whole or in part, it will release the records or parts of
records to the requester and notify the requester of any applicable fee
charged under Sec.  2.107. The office will annotate records released in
part, whenever technically feasible, with the applicable FOIA exemption
or exemptions at that part of the record from which the exempt
information was deleted.
    (i) Adverse determinations of requests. When the Agency makes an
adverse determination, the Agency will notify the requester of that
determination in writing. Adverse determinations include:
    (1) A decision that the requested record is exempt from disclosure,
in whole or in part;
    (2) A decision that the information requested is not a record
subject to the FOIA;
    (3) A decision that the requested record does not exist or cannot
be located;
    (4) A decision that the requested record is not readily
reproducible in the form or format sought by the requester;
    (5) A determination on any disputed fee matter, including a denial
of a request for a fee waiver; or
    (6) A denial of a request for expedited processing.
    (j) Content of final determination letter. The appropriate official
will issue the final determination letter in accordance with Sec.
2.103(b) and will include:
    (1) The name and title or position of the person responsible for
the determination;
    (2) A brief statement of the reason or reasons for the denial,
including an identification of records being withheld (either
individually or, if a large number of similar records are being denied,
described by category) and any FOIA exemption applied by the office in
denying the request;
    (3) An estimate of the volume of records or information withheld,
in number of pages or in some other reasonable form of estimation. This
estimate does not need to be provided if the volume is otherwise
indicated through annotated deletions on records disclosed in part, or
if providing an estimate would harm an interest protected by an
applicable exemption;
    (4) A statement that an adverse determination may be appealed under
Sec.  2.108 and description of the requirements for submitting an
administrative appeal; and
    (5) A statement that the requester has the right to seek dispute
resolution services from an EPA FOIA Public Liaison or the Office of
Government Information Service.

Sec.  2.105  [Reserved]

Sec.  2.106  Preservation of records.

    The Agency will preserve all correspondence pertaining to the FOIA
requests that it receives, as well as copies of all requested records,
until disposition or destruction is authorized pursuant to title 44 of
the United States Code or the National Archives and Records
Administration's General Records Schedule 4.2. Records shall not be
disposed of while they are the subject of a pending request, appeal, or
lawsuit under the FOIA.

Sec.  2.107  Fees.

    (a) In general. The Agency will charge for processing requests
under the FOIA in accordance with this section, except where fees are
limited under paragraph (g) of this section or where a waiver or
reduction of fees is granted under paragraph (n) of this section.
    (b) How to pay fees. Requesters must pay fees by check, money
order, electronically at https://www.pay.gov/, to the Treasury of the
United States.
    (c) Contractor rates. When any search, review, or duplication task
is performed by a contractor, EPA will charge for staff time at the
contractor's actual pay rate, but not exceeding the rates set under
paragraph (f)(2)(ii) of this section.
    (d) Rounding staff time. Billable staff time is calculated by
rounding to the nearest quarter-hour.
    (e) Types of requests for fee purposes. For purposes of this
section, the five types of request categories are defined in paragraphs
(e)(1) through (5) of this section. These request categories will be
charged for the types of fees as noted, subject to the restrictions in
paragraph (g) of this section and unless a fee waiver has been granted
under paragraph (n) of this section. Paragraph (f) of this section
defines and explains how the Agency calculates each type of fee.
    (1) Commercial-use Request. (i) Commercial use request means a
request from or on behalf of a person who seeks information for a use
or purpose that furthers the requester's commercial, trade, or profit
interests, which can include furthering those interests through
litigation. The Agency will determine, whenever reasonably possible,
the use to which a requester will put the requested records. When it
appears that the requester will put the records to a commercial use,
either because of the nature of the request itself or because the
Agency has reasonable cause to doubt a requester's stated use, the
Agency will provide the requester a reasonable opportunity to submit
further clarification.
    (ii) For a commercial-use request, the Agency will charge the
requester for search, review, and duplication.
    (2) Educational institution request. (i) Educational institution
means a preschool, a public or private elementary or secondary school,
an institution of undergraduate higher education, an institution of
graduate higher education, an institution of professional education, or
an institution of vocational education, that operates a program of
scholarly research. To be eligible for inclusion in this category,
requesters must show that the request is being made as authorized by
and under the auspices of a qualifying institution and that the records
are not sought for a commercial use, but are sought in furtherance of
scholarly research.
    (ii) For an educational institution request, the Agency will charge
the requester for duplication, except that the Agency will furnish the
first 100 pages of duplication at no charge.
    (3) Noncommercial scientific institution request. (i) Noncommercial
scientific institution means an institution not operated on a
``commercial'' basis, as defined in paragraph (e)(1) of this section,
and that is operated solely for conducting scientific research that is
not intended to promote any particular product or industry. To be
eligible for inclusion in this category, requesters must show that the
request is being made as authorized by and under the auspices of a
qualifying institution and that the records are not sought for a
commercial

use, but are sought in furtherance of scientific research.
    (ii) For a noncommercial scientific institution request, the Agency
will charge the requester for duplication, except that the Agency will
furnish the first 100 pages of duplication at no charge.
    (4) Representative of the news media requests. (i) Representative
of the news media has the meaning provided at 5 U.S.C.
552(a)(4)(A)(ii).
    (ii) For representative of the news media requests, the Agency will
charge a requester for duplication, except that the Agency will furnish
the first 100 pages of duplication at no charge.
    (5) Other requests. (i) Other requesters are requesters that are
not commercial-use requesters, educational institutions, noncommercial
scientific institutions, or representatives of the news media.
    (ii) The Agency will charge other requesters for search and
duplication, except that the Agency will furnish without charge the
first two hours of search time and the first 100 pages of duplication.
    (f) Types of fees. Paragraphs (f)(1) through (4) of this section
are definitions of the types of fees and explanations of how the Agency
calculates each type of fee.
    (1) Direct costs. Direct costs means those expenses that the Agency
actually incurs in searching for and duplicating (and, in the case of
commercial use requests, reviewing) records to respond to a FOIA
request. Direct costs include, for example, the salary of the employee
performing the work and the cost of operating duplication equipment.
Not included in direct costs are overhead expenses such as the costs of
space and heating or lighting of the facility in which the records are
kept.
    (2) Search. (i) Search means the process of looking for and
retrieving records or information responsive to a request. It includes
page-by-page or line-by-line identification of information within
records and includes reasonable efforts to locate and retrieve
information from records maintained in electronic form or format.
Offices will ensure that searches are done in the most efficient and
least expensive manner reasonably possible. For example, offices will
not search line-by-line where duplicating an entire document would be
quicker and less expensive. The Agency will charge for time spent
searching even if no responsive records are found or if the records are
located but are determined to be exempt from disclosure.
    (ii) Search fees will equal the direct costs of search. Personnel
will bill their time at the following rates using the current Office of
Personnel Management General Schedule (GS) pay table for Washington-
Baltimore-Arlington, DC-MD-VA-WV-PA. The current calculations of these
rates may be found at www.epa.gov/foia.
    (A) GS-12 level or below (or equivalent pay scale): The average of
GS-9 to GS-12 (Step 5), plus 16 percent, rounded to the nearest $1
increment per quarter hour.
    (B) GS-13 level or above (or equivalent pay scale): The average of
GS-13 to GS-15 (Step 5), plus 16 percent, rounded to the nearest $1
increment per quarter hour.
    (iii) For requests that require the retrieval of records stored by
an agency at a Federal Records Center operated by NARA, additional
costs will be charged in accordance with the Transactional Billing Rate
Schedule established by NARA.
    (3) Review. (i) Review means the examination of a record located in
response to a request to determine whether any portion of it is exempt
from disclosure. It also includes processing any record for disclosure
(for example, doing all that is necessary to redact it and prepare it
for disclosure). Review costs are recoverable even if a record
ultimately is not disclosed. Review time includes time spent
considering any formal objection to disclosure made by a business
submitter requesting confidential treatment but does not include time
spent resolving general legal or policy issues regarding the
application of exemptions.
    (ii) The Agency will charge review fees only for the initial record
review (that is, the review done when an office is deciding whether an
exemption applies to a particular record or portion of a record at the
initial request level). The Agency will not charge for review at the
administrative appeal level for an exemption already applied. However,
the Agency may again review records or portions of records withheld
under an exemption that the Agency subsequently determines not to apply
to determine whether any other exemption not previously considered
applies; the Agency will charge costs of that review when a change of
circumstances makes it necessary. The Agency will charge review fees at
the same rates as those charged for a search under paragraph (f)(2)(ii)
of this section.
    (4) Duplication. (i) Duplication means the making of a copy of a
record, or of the information contained in it, necessary to respond to
a FOIA request. Copies can take the form of paper, microform,
audiovisual materials, or electronic records (for example, magnetic
tape, disc, or compact disc), among others. The Agency will honor a
requester's specified preference of form or format of disclosure if the
record is readily reproducible with reasonable efforts in the requested
form or format.
    (ii) For either a photocopy or a computer-generated printout of a
record (no more than one copy of which need be supplied), the fee will
be fifteen (15) cents per page. For electronic forms of duplication,
other than a computer-generated printout, offices will charge the
direct costs of that duplication. Such direct costs will include the
costs of the requested electronic medium on which the copy is to be
made and the actual operator time and computer resource usage required
to produce the copy, to the extent they can be determined. The Agency
will charge operator time at the same rates as those charged for search
under paragraph (f)(2)(ii) of this section.
    (g) Limitations on charging fees. (1) The Agency will charge no fee
when a total fee calculated under paragraph (c) of this section is less
than fourteen times the rate in paragraph (f)(2)(ii)(B) of this section
rounded to the nearest $5.00 increment for any request. The current
calculation of this threshold may be found at www.epa.gov/foia.
    (2) The restrictions in paragraphs (e)(1)(ii), (2)(ii), (3)(ii),
(4)(ii), and (5)(ii) and minimum fee threshold in (g)(1) of this
section work together. This means that for requesters other than those
seeking records for a commercial use, the Agency will charge no fee
unless the cost of search more than two hours plus the cost of
duplication in excess of 100 pages totals more than fourteen times the
rate in paragraph 2.107(f)(2)(ii)(B) of this section rounded to the
nearest $5.00 increment. The current calculation of this threshold may
be found at www.epa.gov/foia.
    (3) If EPA fails to comply with the FOIA's time limits for
responding to a request, EPA will not charge search fees, or, in the
instance of requesters described in paragraphs (e)(2) through (4) of
this section, duplication fees, except as follows:
    (i) If EPA determined that unusual circumstances as defined by the
FOIA apply and the Agency provided timely written notice to the
requester in accordance with the FOIA, a failure to comply with the
time limit shall be excused for an additional 10 working days;
    (ii) If EPA determined that unusual circumstances as defined by the
FOIA apply and more than 5,000 pages are necessary to respond to the
request, EPA may charge search fees, or, in the case of requesters
described in paragraphs (e)(2) through (4) of this section, may charge
duplication fees, if the following steps are taken: EPA must have

provided timely written notice of unusual circumstances to the
requester in accordance with the FOIA and the EPA must have discussed
with the requester by written mail, email, 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 in accordance with 5 U.S.C.
552(a)(6)(B)(ii), which includes notification to the requester of the
availability of the FOIA Public Liaison and the right to seek dispute
resolution services from the Office of Government Information Services.
If this exception is satisfied, EPA may charge all applicable fees
incurred in the processing of the request; or
    (iii) If a court determines that exceptional circumstances exist,
as defined by the FOIA, a failure to comply with the time limits shall
be excused for the length of time provided by the court order.
    (h) Assurance of payment and advanced payment of fees. (1) If EPA
determines that the actual or estimated fees exceed the amount in
paragraph (g)(1) of this section, the Agency will notify the requester
of the actual or estimated amount, toll the processing clock, and will
do no further work on the request until the requester agrees in writing
to pay the anticipated total fee.
    (2) If EPA determines that the actual or estimated fees exceed
twenty-five times the amount in paragraph (f)(2)(ii)(B) of this
section, the Agency will notify the requester of the actual or
estimated amount, and may toll the processing clock and do no further
work on the request until the requester pays the estimated or actual
fee. The current calculation of this amount may be found at
www.epa.gov/foia.
    (3) After providing the requester with estimated fee amounts, EPA
will provide the requester with an opportunity to discuss with the
Agency how to modify the request to meet the requester's needs at a
lower cost.
    (4) EPA calculates the estimated or actual fee cumulatively for
multi-component requests. If only a part of the fee can be estimated
readily, the Agency will advise the requester that the estimated fee
may be only a portion of the total fee.
    (5) If, after the requester provided an assurance of payment or
paid an initially estimated or actual amount of fees, the Agency
increases the estimated or actual amount of fees, the Agency will
notify the requester, stop further processing of the request, and toll
any deadline for responding to the request. Once the requester provides
assurance of payment or pays the fees, the time to respond to the
request will resume from where it was at the date of the tolling
notification.
    (i) Charges for other services. Although not required to provide
special services, if EPA chooses to do so as a matter of administrative
discretion, the direct costs of providing the service will be charged
to the requester. Examples of such services include certifying that
records are true copies, sending records by other than EPA's electronic
FOIA management system or U.S. Mail, or providing multiple copies of
the same document.
    (j) Charging interest. EPA may charge interest on any unpaid bill
starting on the 31st day following the date of billing the requester.
The Agency will assess interest charges at the rate provided in 31
U.S.C. 3717 and will accrue from the date of the billing until the
Agency receives payment. EPA will follow the provisions of the Debt
Collection Act of 1982 (Pub. L. 97-365), as amended, and its
administrative procedures, including the use of consumer reporting
agencies, collection agencies, and offset. The Agency will assess no
penalty against FOIA requesters for exercising their statutory right to
ask the Agency to waive or reduce a fee or to dispute a billing. If a
fee is in dispute, the Agency will suspend penalties upon notification.
    (k) Delinquent requesters. (1) If a requester fails to pay all fees
charged to the requester under the FOIA by EPA or any other Federal
agency within 60 calendar days of the date the fees were billed, the
Agency will treat the requester as delinquent. The Agency may share
information regarding delinquent requesters with other Federal
agencies.
    (2) Before EPA continues processing a pending FOIA request or
begins processing any new FOIA requests from a delinquent requester,
the delinquent requester must pay the full amount due, plus any
applicable interest, on that prior request and make an advance payment
of the full amount of any anticipated fee.
    (3) When the Agency requires payment under paragraph (h)(2) of this
section, the request will not be considered received until the required
payment is made. If the requester does not pay the outstanding balance
and the advance payment within 30 calendar days after the date of EPA's
fee determination, the request will be closed.
    (l) Aggregating requests. If a requester or a group of requesters
acting in concert submit two or more requests that involve related
matters and paragraphs (l)(1), (2), or both of this section, apply then
the Agency may aggregate those requests and charge fees accordingly.
Multiple FOIA requests involving unrelated matters shall not be
aggregated. An aggregated group of FOIA requests will be treated as a
single FOIA request under this subpart, including evaluation of whether
unusual circumstances exist.
    (1) The Agency reasonably believes that if the requests constituted
a single request, such a request would result in unusual circumstances
pursuant to Sec.  2.104(f); or
    (2) The Agency reasonably believes that the requester or requesters
acting together are attempting to divide a request into a series of
requests for the purpose of avoiding fees. The Agency may presume that
such requests have been submitted to avoid fees if submitted within a
30-day period. When requests are submitted by a period greater than 30
days, the Agency will aggregate them only if there exists a solid basis
for determining that aggregation is warranted under all the
circumstances involved.
    (m) Other statutes specifically providing for fees. The fee
schedule of this section does not apply to fees charged under any other
statute that specifically requires an agency to set and collect fees
for particular types of records. When records responsive to requests
are maintained for distribution by agencies operating such statutorily
based fee schedule programs, EPA will inform requesters of the steps
for obtaining records from those sources so that they may do so most
economically.
    (n) Waiver or reduction of fees. (1) A request for a waiver or
reduction of FOIA fees must be made at the time of the initial
submission of a FOIA request. An untimely request for a waiver or
reduction of fees will be denied.
    (2) Requests for the waiver or reduction of fees must address the
factors listed in paragraphs (n)(4) through (6) of this section, as far
as they apply to each request. EPA components will exercise their
discretion to consider the cost-effectiveness of their investment of
administrative resources in deciding whether to grant waivers or
reductions of fees and will consult the appropriate EPA components as
needed. Requesters must submit requests for the waiver or reduction of
fees along with the request.

    (3) When only some of the requested records satisfy the
requirements for a waiver of fees, the Agency will grant a waiver for
only those records.
    (4) Records responsive to a request will be furnished without
charge or at a charge reduced below that established under paragraph
(c) of this section when the Agency determines, based on all available
information, that disclosure of the requested information is in the
public interest because it is:
    (i) Likely to contribute significantly to public understanding of
the operations or activities of the government, and
    (ii) Is not primarily in the commercial interest of the requester.
    (5) To determine whether the request meets the first fee waiver
requirement, the Agency will consider the following factors:
    (i) The subject of the request. Whether the subject of the
requested records concerns ``the operations or activities of the
government.'' The subject of the requested records must concern
identifiable operations or activities of the Federal government, with a
connection that is direct and clear, not remote.
    (ii) The informative value of the information to be disclosed.
Whether the disclosure is ``likely to contribute'' to an understanding
of government operations or activities. The disclosable portions of the
requested records must be meaningfully informative about government
operations or activities in order to be ``likely to contribute'' to an
increased public understanding of those operations or activities. The
disclosure of information that already is in the public domain, in
either a duplicative or a substantially identical form, would not be as
likely to contribute to such understanding when nothing new would be
added to the public's understanding.
    (iii) The contribution to an understanding of the subject by the
public is likely to result from the disclosure. Whether disclosure of
the requested information will contribute to ``public understanding.''
The disclosure must contribute to the understanding of a reasonably
broad audience of persons interested in the subject, as opposed to the
individual understanding of the requester. The Agency will consider a
requester's expertise in the subject area and ability and intention to
effectively convey information to the public. The Agency presumes that
a representative of the news media will satisfy this consideration.
    (iv) The significance of the contribution to public understanding.
Whether the disclosure is likely to contribute ``significantly'' to
public understanding of government operations or activities. The
public's understanding of the subject in question, as compared to the
level of public understanding existing prior to the disclosure, must be
enhanced by the disclosure to a significant extent. The Agency will not
make value judgments about whether information that would contribute
significantly to public understanding of the operations or activities
of the government is ``important'' enough to be made public.
    (6) To determine whether the request meets the second fee waiver
requirement, the Agency will consider the following factors:
    (i) The existence and magnitude of a commercial interest. Whether
the requester has a commercial interest that would be furthered by the
requested disclosure. The Agency will consider any commercial interest
of the requester (with reference to the definition of ``commercial use
request'' in paragraph (e)(1) of this section), or of any person on
whose behalf the requester may be acting, that would be furthered by
the requested disclosure. The Agency will give the requester an
opportunity in the administrative process to provide explanatory
information regarding this consideration.
    (ii) The primary interest in disclosure. Whether any identified
commercial interest of the requester is sufficiently large, in
comparison with the public interest in disclosure, that disclosure is
``primarily in the commercial interest of the requester.'' A fee waiver
or reduction is justified where the public interest standard is
satisfied and that public interest is greater in magnitude than that of
any identified commercial interest in disclosure. The Agency ordinarily
will presume that when a news media requester has satisfied the public
interest standard, the public interest will be the interest primarily
served by disclosure to that requester. The Agency will not presume
that disclosure to data brokers or others who merely compile and market
government information for direct economic return is to primarily serve
the public interest.

Sec.  2.108  Administrative appeals.

    (a) Appeals of adverse determinations. To appeal an adverse
determination, a requester must submit an appeal in writing within 90
calendar days from the date of the letter communicating the Agency's
adverse determination, and by one of the following methods:
    (1) EPA's FOIA submission website, linked to at www.epa.gov/foia;
    (2) U.S. Mail sent to the following address: National FOIA Office,
U.S. Environmental Protection Agency, 1200 Pennsylvania Avenue NW
(2310A), Washington, DC 20460; or
    (3) Overnight delivery service to National FOIA Office, U.S.
Environmental Protection Agency, 1200 Pennsylvania NW, Room 7309C,
Washington, DC 20460.
    (b) Timing for administrative appeals submitted electronically.
Requesters submitting appeals electronically must do so before 5 p.m.
Eastern Time for the Agency to consider the appeal as received on that
date, and appeals submitted electronically at or after 5 p.m. Eastern
Time will be considered received by the National FOIA Office on the
next business day.
    (c) Content of administrative appeal. The appeal may include as
much or as little related information as the requester wishes. The
appeal must clearly identify the office's determination that is being
appealed and the assigned request tracking number. For quickest
handling of appeals sent via U.S. Mail or overnight delivery service,
the requester must mark their appeal letter and its envelope with
``Freedom of Information Act Appeal.''
    (d) Authority to make decision on appeal. Unless the Administrator
directs otherwise, the General Counsel or the General Counsel's
delegate will act on behalf of the Administrator on all appeals under
this section, except that:
    (1) The Counsel to the Inspector General will act on any appeal
where the Inspector General or the Inspector General's delegate has
made the final adverse determination; however, if the Counsel to the
Inspector General has signed the final adverse determination, the
General Counsel or the General Counsel's delegate will act on the
appeal;
    (2) An adverse determination by the Administrator on an initial
request will serve as the final action of the Agency; and
    (3) An appeal ordinarily will not be adjudicated if the request
becomes a matter of FOIA litigation.
    (e) Timing of decision on appeal. EPA will make the decision on the
appeal in writing, normally within 20 working days of its receipt by
the National FOIA Office.
    (1) A decision affirming an adverse determination in whole or in
part will contain a statement of the reason or reasons for the
decision, including any FOIA exemption or exemptions applied, inform
the requester of dispute resolution services offered by the Office of
Government Information Service of the National Archives and Records
Administration, and inform the

requester of the FOIA provisions for judicial review of the decision.
    (2) If the Agency reverses or modifies the adverse determination on
appeal, the Agency will attach the requested information that the
Agency determined on appeal to be releasable, or the Agency will return
the request to the appropriate office so that the office may reprocess
the request in accordance with the appeal decision.
    (f) When appeal is required. If the requester wishes to seek
judicial review of any adverse determination, the requester must first
appeal that adverse determination under this section, except when EPA
has not responded to the request within the applicable time-period. In
such cases, the requester may seek judicial review without making an
administrative appeal.

Sec.  2.109  Other rights and services.

    Nothing in this subpart shall be construed to entitle any person,
as a right, to any service or to the disclosure of any record to which
such person is not entitled under the FOIA.

[FR Doc. 2023-19699 Filed 9-13-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: December 14, 2006 (Volume 71, Number 240)]
[Notices]
[Page 75238-75239]
[DOCID:fr14de06-41]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC07-580-000; FERC 580]

Commission Information Collection Activities, Proposed
Collection; Comment Request; Extension

December 7, 2006.
AGENCY: Federal Energy Regulatory Commission, DOE.

ACTION: Notice.

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SUMMARY: In compliance with the requirements of section 3506(c)(2)(a)
of the Paperwork Reduction Act of 1995 (Pub. L. No. 104-13), the
Federal Energy Regulatory Commission (Commission) is soliciting public
comment on the specific aspects of the information collection described
below.

DATES: Comments on the collection of information are due February 16,
2007.

ADDRESSES: Copies of sample filings of the proposed collection of
information can be obtained from the Commission's Web site (http://www.ferc.gov/docs-filings/elibrary.asp
) or from the Federal

Energy Regulatory Commission, Attn: Michael Miller, Office of the
Executive Director, ED-34, 888 First Street, NE., Washington, DC 20426.
Comments may be filed either in paper format or electronically. Those
parties filing electronically do not need to make a paper filing. For
paper filing, the original and 14 copies of such comments should be
submitted to the Secretary of the Commission, Federal Energy Regulatory
Commission, 888 First Street, NE., Washington, DC 20426 and refer to
Docket No. IC07-580-000.
    Documents filed electronically via the Internet must be prepared in
WordPerfect, MS Word, Portable Document Format, or ASCII format. To
file the document, access the Commission's Web site at http://www.ferc.gov
 and click Documents and Filing tab, then choose eFiling

from the drop-down menu. Follow the instructions provided. First time
users will have to establish a user name and password. The Commission
will send an automatic acknowledgement to the sender's e-mail address
upon receipt of comments.
    All comments may be viewed, printed or downloaded remotely via the
Internet through the Commission's homepage using the eLibrary link. For
user assistance, contact<EMAIL_ADDRESS>or toll-free at
(866) 208-3676 or for TTY, contact<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Michael Miller may be reached by
telephone at<PHONE_NUMBER>, by fax at<PHONE_NUMBER>, and by e-mail at
<EMAIL_ADDRESS>

SUPPLEMENTARY INFORMATION: The information collected under the
requirements of FERC Form No. 580 ``Interrogatory on Fuel and Energy
Purchase Practices, Docket No. IN79-6''--(OMB No. 1902-0137) is used by
the Commission to carry out its responsibilities in implementing the
statutory provisions of the Federal Power Act (FPA). The FPA was
amended by the Public Utility Regulatory Policies Act (49 Stat. 851; 16
U.S.C. 824d) to require the Commission to review ``not less frequently
than every two (2) years * * * of practices * * * to ensure efficient
use of resources (including economical purchase and use of fuel and
electric energy) * * *'' The collection of this information is
specifically required by Federal statute (FPA Section 205(f)) and thus
the Commission lacks authority to allow waivers for the filing of this
information. In addition, the Commission entertains requests for
confidential treatment pursuant to 18 CFR 388.112 for the coal mine
price data and coal rail transportation cost data submitted in response
to questions 3(i) and 3(1.2), respectively, only when disclosure would
violate the terms of a confidentiality clause of a rail transportation
contract. No other requests for confidential treatment are considered.
The information is used to: (1) Review as mandated by statute, fuel
purchase and cost recovery practices to ensure efficient use of
resources, including economical purchase and use of fuel and electric
energy, under fuel adjustment clauses on file with the Commission; (2)
evaluate fuel costs in individual rate filings; (3) supplement periodic
utility audits. The information has also been used by the Energy
Information Administration under a Congressional mandate to study
various aspects of coal, oil, and gas transportation rates.
    Action: The Commission is requesting a three-year extension of the
current expiration date, with no changes to the existing collection of
data.
    Burden Statement: Public reporting burden for this collection is
estimated as:

----------------------------------------------------------------------------------------------------------------
                                                           Number of
           Number of respondents annually                responses per      Average burden       Total annual
                                                          respondent      hours per response     burden hours
----------------------------------------------------------------------------------------------------------------
(1)                                                                 (2)                 (3)     (1) x (2) x (3)
----------------------------------------------------------------------------------------------------------------
114*................................................                 57      63.16              3,600
----------------------------------------------------------------------------------------------------------------
*(114 responses every two years).
 rounded off.

    Estimated cost burden to respondents is $211,391. (3,600 hours/2080
hours per year times $122,137 per year average per employee = $
211,391). The cost per respondent is $1,854).
    The reporting burden includes the total time, effort, or financial
resources expended to generate, maintain, retain, disclose, or provide
the information including: (1) Reviewing instructions; (2) developing,
acquiring, installing, and utilizing technology and systems for the
purposes of collecting, validating, verifying, processing, maintaining,
disclosing and providing information; (3) adjusting the existing ways
to comply with any previously applicable instructions and requirements;
(4) training personnel to respond to a collection of information; (5)
searching data sources; (6) completing and reviewing the collection of
information; and (7) transmitting, or otherwise disclosing the
information.
    The estimate of cost for respondents is based upon salaries for
professional and clerical support, as well as direct and indirect
overhead costs. Direct costs include all costs directly attributable to
providing this information, such as administrative costs and the cost
for information technology. Indirect or overhead costs are costs
incurred by an organization in support of its mission. These costs
apply to activities, which benefit the whole organization rather than
any one particular function or activity.
    Comments are invited on: (1) Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Commission, including whether the information will have practical
utility; (2) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility and clarity of the information to be collected; and (4) ways to
minimize the burden of the collection of information on those who are
to respond, including the use of appropriate automated, electronic,
mechanical, or other technological collection techniques or other forms
of information technology, e.g., permitting electronic submission of
responses.

Magalie R. Salas,
Secretary.
[FR Doc. E6-21245 Filed 12-13-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 41 (Thursday, March 2, 2023)]
[Notices]
[Pages 13126-13128]
[FR Doc No: 2023-04267]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-0202]

Potency Assay Considerations for Monoclonal Antibodies and Other
Therapeutic Proteins Targeting Viral Pathogens; Draft Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``Potency
Assay Considerations for Monoclonal Antibodies and Other Therapeutic
Proteins Targeting Viral Pathogens.'' The purpose of this draft
guidance is to provide to sponsors recommendations that assist in the
development of monoclonal antibodies (mAbs) and other therapeutic
proteins that directly target viral proteins or host cell proteins
mediating pathogenic mechanisms of infection. A critical quality
control measure for these products is the development and
implementation of a potency assay(s) adequate to ensure that each lot
is produced consistently with the potency necessary to achieve clinical
efficacy and that such potency is maintained over the shelf life of the
product. This draft guidance provides detailed recommendations to drug
developers with the goal of helping to ensure that drug developers
provide adequate information to assess potency at each stage of a
product's life cycle.

DATES: Submit either electronic or written comments on the draft
guidance by May 1, 2023 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-0202 for ``Potency Assay Considerations for Monoclonal
Antibodies and Other Therapeutic Proteins Targeting Viral Pathogens.''
Received comments will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002. Send one
self-addressed adhesive label to assist that office in processing your
requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Natalia Comella, Center for Drug
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 75, Rm. 6648, Silver Spring, MD 20993-0002, 301-
796-6226.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Potency Assay Considerations for Monoclonal Antibodies and
Other Therapeutic Proteins Targeting Viral Pathogens.'' The purpose of
this draft guidance is to provide to sponsors recommendations that
assist in the development of mAbs and other therapeutic proteins that
directly target viral proteins or host cell proteins mediating
pathogenic mechanisms of infection. A critical quality control measure
for these products is the development and implementation of a potency
assay(s) adequate to ensure that each lot is produced consistently with
the potency necessary to achieve clinical efficacy and that such
potency is maintained over the shelf life of the product. This draft
guidance provides detailed recommendations to drug developers with the
goal of helping to ensure that drug developers provide adequate
information to assess potency at each stage of a product's life cycle.
    This draft guidance applies only to mAbs and other therapeutic
proteins regulated by the Center for Drug Evaluation and Research that
are designed to bind to viral proteins or their receptors on host
cells, inhibit

viral entry, and/or elicit Fc-mediated effector function and are
subject to licensure under section 351(a) or section 351(k) of the
Public Health Service Act (PHS Act) (42 U.S.C. 262(a) or (k)). This
draft guidance does not apply to immunomodulatory drugs (e.g.,
cytokines or cytokine antagonists), vaccines, hyperimmune globulins,
gene therapies, cell therapies, and convalescent plasma.
    The draft guidance describes approaches that sponsors should use to
develop potency assay methods for release and stability that assess
comprehensively known or potential mechanism(s) of action of the
product. The sensitivity of these methods must be established, for
example, to conduct the appropriate laboratory determination of
satisfactory conformance to final specifications for the drug product
(i.e., demonstrate lot-to-lot consistency). In addition to release and
stability methods, other methods that demonstrate the biological
function(s) of the product may be needed for characterization and
comparability studies. The draft guidance describes methods that
sponsors should use to ensure the potency of mAbs and other therapeutic
proteins proposed to prevent or treat a viral infection.
    In January 2021, FDA published the guidance for industry entitled
``COVID-19: Potency Assay Considerations for Monoclonal Antibodies and
Other Therapeutic Proteins Targeting SARS-CoV-2 Infectivity''
(available at https://www.fda.gov/media/145128/download) to support
public health efforts following a declaration, under section 319 of the
PHS Act (42 U.S.C. 247d), by the Secretary of Health and Human Services
of a public health emergency related to Coronavirus Disease 2019 (the
disease caused by SARS-CoV-2) (section 319 public health emergency).
The 2021 guidance focuses solely on addressing potency assays as they
relate to mAbs and other therapeutic proteins that directly target
SARS-CoV-2, and it is intended to remain in effect only for the
duration of the section 319 public health emergency related to
Coronavirus Disease 2019. However, FDA believes that many of the
recommendations set forth in the 2021 guidance are applicable outside
the context of the section 319 public health emergency and are
applicable to mAbs and other therapeutic proteins directly targeting
any viral surface (glyco)proteins mediating pathogenic mechanisms of
infection, not just those that directly target SARS-CoV-2. FDA is,
therefore, issuing this draft guidance. In preparing this guidance, FDA
considered comments received regarding the 2021 guidance as well as the
Agency's experience with SARS-CoV-2 and other viruses.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Potency
Assay Considerations for Monoclonal Antibodies and Other Therapeutic
Proteins Targeting Viral Pathogens.'' It does not establish any rights
for any person and is not binding on FDA or the public. You can use an
alternative approach if it satisfies the requirements of the applicable
statutes and regulations.

II. Paperwork Reduction Act of 1995

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. Therefore,
clearance by the Office of Management and Budget (OMB) under the
Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in 21 CFR part 312 for submission of an investigational
new drug application have been approved under OMB control number 0910-
0014. The collections of information in 21 CFR part 314 for new drug
applications have been approved under OMB control number 0910-0001. The
collections of information in 21 CFR parts 601 and 610 pertaining to
biologics license applications have been approved under OMB control
number 0910-0338. The collections of information in 21 CFR parts 210
and 211 pertaining to current good manufacturing practices have been
approved under OMB control number 0910-0139. The collections of
information in 21 CFR part 11 pertaining to electronic records and
signatures have been approved under OMB control number 0910-0303.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: February 27, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-04267 Filed 3-1-23; 8:45 am]
BILLING CODE 4164-01-P


Placeholder: Confidential Business Information version of
“Company-Specific Allocation of CSAs.”

For more information please contact Aaron Levy by phone at<PHONE_NUMBER>
or by email at   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>


[Federal Register: February 29, 2008 (Volume 73, Number 41)]
[CORRECTIONS]
[Page 11192]
[DOCID:fr29fe08-153]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2007-0205; Airspace Docket No. 07-ANM-17]

Proposed Establishment of Class E Airspace; Walden CO

Correction

    In proposed rule document E8-844, beginning on page 3431 in the
issue of Friday, January 18, 2008, make the following correction:

Sec.  71.1  [Corrected]

    On page 3432, in Sec.  71.1, in the second column, in the eighth
line, ``(Lat. 40[deg]45[min]0[sec] N., long. 106[deg]16[min]17[sec]
W.)'' should read``(Lat.40[deg]45[min]01[sec] N., long.
106[deg]16[min]17[sec] W.)''.

[FR Doc. Z8-844 Filed 2-28-08; 8:45 am]

BILLING CODE 1505-01-D