[Federal Register: October 31, 2008 (Volume 73, Number 212)]
[Notices]
[Page 64941-64943]
[DOCID:fr31oc08-64]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2004-0501; FRL-8737-3]

Agency Information Collection Activities; Submission to OMB for
Review and Approval; Comment Request; Reporting Requirements Under
EPA's Green Power Partnership and Combined Heat and Power (CHP)
Partnership, ICR Number 2173.02 (Renewal), OMB Control No. 2060-0578

AGENCY: Environmental Protection Agency.

ACTION: Notice.

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SUMMARY: In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved information request ICR
to the Office of Management and Budget (OMB) for review and approval.
This ICR is scheduled to expire on April 30, 2009. Before submitting
the ICR to OMB for review and approval EPA is soliciting comments on
specific aspects of the proposed information collection as described
below.

DATES: Additional comments may be submitted on or before December 1,
2008.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2004-0501, to (1) EPA online using http://www.regulations.gov
(preferred method), by e-mail to<EMAIL_ADDRESS>or by
mail to: EPA Docket Center, Environmental Protection Agency, Air and
Radiation Docket and Information Center, MC 6102T, 1200 Pennsylvania
Avenue, NW., Washington, DC 20460, and (2) OMB by mail to: Office of
Information and Regulatory Affairs, Office of Management and Budget
(OMB), Attention: Desk Officer for EPA, 725 17th Street, NW.,
Washington, DC 20503.

FOR FURTHER INFORMATION CONTACT: Blaine Collison, Climate Protection
Partnerships Division, Office of Atmospheric Programs, 6202J,
Environmental Protection Agency, 1200 Pennsylvania Avenue, NW.,
Washington, DC 20460; telephone number:<PHONE_NUMBER>; fax number:
(202) 565-2134; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: EPA has submitted the following ICR to OMB
for review and approval according to the procedures prescribed in 5 CFR
1320.12. On November 10, 2005 (70 FR 68441), EPA sought comments on
this ICR

pursuant to 5 CFR 1320.8(d). EPA received no comments. Any additional
comments on this ICR should be submitted to EPA and OMB within 30 days
of this notice.
    EPA has established a public docket for this ICR under Docket ID
No. EPA-HQ-OAR-2004-0501, which is available for online viewing at
http://www.regulations.gov, or in person viewing at the Air and
Radiation Docket and Information Center in the EPA Docket Center (EPA/
DC), EPA West Building, Room B102, 1301 Constitution Avenue, NW.,
Washington, DC. The EPA/DC Public Reading Room is open from 8 a.m. to
4:30 p.m., Monday through Friday, excluding legal holidays. The
telephone number for the Reading Room is<PHONE_NUMBER>, and the
telephone number for the Air and Radiation Docket is<PHONE_NUMBER>.
    Use EPA's electronic docket and comment system at http://
www.regulations.gov, to submit or view public comments, access the
index listing of the contents of the docket, and to access those
documents in the docket that are available electronically. Once in the
system, select ``docket search,'' then key in the docket ID number
identified above. Please note that EPA's policy is that public
comments, whether submitted electronically or on paper, will be made
available for public viewing at http://www.regulations.gov as EPA
receives them and without change, unless the comment contains
copyrighted material, Confidential Business Information (CBI), or other
information whose public disclosure is restricted by statute. For
further information about the electronic docket, go to http://
www.regulations.gov.
    Title: Reporting Requirements Under EPA's Green Power Partnership
and Combined Heat and Power (CHP) Partnership.
    ICR numbers: EPA ICR No. 2173.02, OMB Control No. 2060-0532.
    ICR Status: This ICR is scheduled to expire on April 30, 2009.
Under OMB regulations, the Agency may continue to conduct or sponsor
the collection of information while this submission is pending at OMB.
An Agency may not conduct or sponsor, and a person is not required to
respond to, a collection of information, unless it displays a currently
valid OMB control number. The OMB control numbers for EPA's regulations
in title 40 of the CFR, after appearing in the Federal Register when
approved, are listed in 40 CFR part 9, and included on the related
collection instrument or form, if applicable.
    Abstract: In an effort to aid implementation of the President's May
2001 National Energy Strategy, as well as the President's February 2002
Climate Change Strategy, EPA launched two new partnership programs with
industry and other stakeholders: the Green Power Partnership and the
Combined Heat and Power (CHP) Partnership. These voluntary partnership
programs encourage organizations to invest in clean, efficient energy
technologies, including renewable energy and combined heat and power.
To continue to be successful, it is critical that EPA collect
information from Green Power and CHP Partners to ensure these
organizations are meeting their renewable energy and CHP goals and to
assure the creditability of these voluntary partnership programs.
    EPA has developed this ICR to obtain authorization to collect
information from organizations participating in the Green Power
Partnership and CHP Partnership. Organizations that join these programs
voluntarily agree to the following respective actions: (1) Designating
a Green Power or CHP liaison and filling out a Partnership Agreement or
Letter of Intent (LOI) respectively, (2) for the Green Power
Partnership, reporting to EPA, on an annual basis, their progress
toward their green power commitment via a 2-page reporting form; (3)
for the CHP Partnership, reporting to EPA information on their existing
CHP projects and CHP development activity. EPA uses the data obtained
from its partners to assess the success of these programs in achieving
their national energy and greenhouse gas (GHG) reduction goals.
Partners are organizational entities that have volunteered to
participate in either Partnership program.
    Burden Statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated to equal 5905
hours and to average 3.24 hours per year per respondent. The average
number of annual burden hours on first year partners for each type of
one-time response is: 8.8 hours for a Partnership Agreement (a one-time
burden for Green Power); 3.5 hours for a Letter of Intent (a one-time
burden for CHP Partners), 2.6 hours for the Partner Yearly Report for
the GPP, 3.94 hours for the Partner Yearly Report for the CHP
Partnership.
    Partners from both programs may also submit voluntary updates of
simple information, such as contact information or company profiles,
via the Web site. These updates would take from 15 minutes to 0.5 hours
per response. A subset of partners may participate in brief (i.e., 15
minute) telephone calls with EPA to clarify questions pertaining to the
Partnership Agreement or LOI, Green Power Partner Yearly Report or CHP
Partner project reporting. All of these activities are included in the
annual burden estimate.
    The estimated number of annual respondents averaged over three (3)
years is 1,820 which includes an average of 1558 for the Green Power
Partnership and 262 respondents for the CHP Partnership.
    There are no capital or start-up costs associated with this
information collection. The average annual operation and maintenance
cost resulting for this collection of information is $3 per respondent.
The average annual labor cost is $287 per respondent. The resulting
total annual cost averaged over the three year period is $521,937. In
the previous ICR the total cost averaged over the 3-year period was
$298,866. The total cost estimate increase for Partners is due to an
increase in the number of Partners and increases in wages.
    Burden means the total time, effort, or financial resources
expended by persons to generate, maintain, retain, or disclose or
provide information to or for a Federal agency. This includes the time
needed to review instructions; develop, acquire, install, and utilize
technology and systems for the purposes of collecting, validating, and
verifying information, processing and maintaining information, and
disclosing and providing information; adjust the existing ways to
comply with any previously applicable instructions and requirements
which have subsequently changed; train personnel to be able to respond
to a collection of information; search data sources; complete and
review the collection of information; and transmit or otherwise
disclose the information.
    Respondents/Affected Entities:
    Estimated Number of Respondents: 1,820.
    Frequency of Response: Annually, on Occasion, One time.
    Estimated Total Annual Hour Burden: 5,905.
    Estimated Total Annual Cost: $663,992, which includes $0 annualized
Capital Startup costs, $5,544 annualized Operating and Maintenance
(O&M) costs and $658,448 annualized Labor costs. Changes in the
Estimates: Since the last ICR renewal, both the Green Power Partnership
and CHP Partnership have introduced program efficiencies to reduce
program burden and simplified collection forms into pre-populated
spreadsheets or documents. As a result of these changes, the average
number of hours per Partner has decreased from 3.4 hours to 3.24 hours
but the total

hourly burden still increased because of an increase in the number of
Partners. For perspective on the magnitude of partner growth, the
number of Partners at the end of 2004 was 865, whereas by year-end
there will be an estimated 1,286.
    The total cost estimate over the 3 year period for this renewal ICR
is $1,991,978, or an average of $663,992 per year, of which $16,632 is
O&M costs. The total cost to GPP and CHP Partners is $1,549,178 (16,632
is O&M), or $516,393 (5,544 is O&M) per year. In the previous 2004 ICR
renewal, the total cost over the 3 year period was $1,101,749. The
total cost estimate increase for Partners is due to an increase in the
number of Partners and increases in wages.

    Dated: October 24, 2008.
Kathleen Hogan,
Director, Climate Protection Partnership Division.
[FR Doc. E8-26017 Filed 10-30-08; 8:45 am]

BILLING CODE 6560-50-P


[Federal Register Volume 83, Number 179 (Friday, September 14, 2018)]
[Notices]
[Pages 46732-46733]
[FR Doc No: 2018-20036]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OAR-2004-0501; FRL-9983-76-OAR]

Proposed Information Collection Request; Comment Request;
Information Collection Request for Green Power Partnership and Combined
Heat and Power Partnership; EPA ICR Number 2173.07 (Renewal), OMB
Control No. 2060-0578

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency is planning to submit an
information collection request (ICR), ``Information Collection Request
for Green Power Partnership and Combined Heat and Power Partnership''
(EPA ICR Number 2173.07 (Renewal), OMB Control No. 2060-0578) to the
Office of Management and Budget (OMB) for review and approval in
accordance with the Paperwork Reduction Act. Before doing so, EPA is
soliciting public comments on specific aspects of the proposed
information collection as described below. This is a proposed extension
of the ICR, which is currently approved through March 31, 2019. An
Agency may not conduct or sponsor and a person is not required to
respond to a collection of information unless it displays a currently
valid OMB control number.

DATES: Comments must be submitted on or before November 13, 2018.

ADDRESSES: Submit your comments, referencing Docket ID No. EPA-HQ-OAR-
2004-0501, online using www.regulations.gov (our preferred method), by
email to [email protected] or by mail to: EPA Docket
Center, Environmental Protection Agency, Mail Code 28221T, 1200
Pennsylvania Ave. NW, Washington, DC 20460. EPA's policy is that all
comments received will be included in the public docket without change
including any personal information provided, unless the comment
includes profanity, threats, information claimed to be Confidential
Business Information (CBI) or other information whose disclosure is
restricted by statute.

FOR FURTHER INFORMATION CONTACT: Christopher Kent, Climate Protection
Partnerships Division, Office of Atmospheric Programs, MC 6202A
Environmental Protection Agency, 1200 Pennsylvania Ave. NW, Washington,
DC 20460; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents which explain in detail
the information that the EPA will be collecting are available in the
public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Pursuant to section 3506(c)(2)(A) of the PRA, EPA is soliciting
comments and information to enable it to: (i) Evaluate whether the
proposed collection of information is necessary for the proper
performance of the functions of the Agency, including whether the
information will have practical utility; (ii) evaluate 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; (iii) enhance the quality, utility, and clarity of the
information to be collected; and (iv) minimize the burden of the
collection of information on those who are to respond, including
through 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. EPA
will consider the comments received and amend the ICR as appropriate.
The final ICR package will then be submitted to OMB for review and
approval. At that time, EPA will issue another Federal Register notice
to announce the submission of the ICR to OMB and the opportunity to
submit additional comments to OMB.
    Abstract: In 2002, EPA's Energy Supply and Industry Branch (ESIB)
launched two partnership programs with industry and other stakeholders:
The Green Power Partnership (GPP) and the Combined Heat and Power
Partnership (CHPP). These voluntary partnership programs, along with
others in the ESIB, encourage organizations to invest in clean,
efficient energy technologies, including renewable energy and combined
heat and power. To continue to be successful, it is critical that EPA
collect information from these program stakeholders to ensure these
organizations are meeting their clean energy goals and to assure the
credibility of these voluntary non-regulatory programs.
    EPA has developed this ICR to obtain authorization to collect
information from organizations participating in the GPP and CHPP, and
other ESIB voluntary programs. Organizations that join these programs
voluntarily agree to the following respective actions: (1) Designating
a Green Power or CHP liaison and filling out a Partnership Agreement or
Letter of Intent (LOI) respectively, (2) for the GPP, reporting to EPA,
on an annual basis, their progress toward their green power commitment
via a 3-page reporting form; (3) for the CHP Partnership, reporting to
EPA information on their existing CHP projects, new project
development, and other CHP-related

activities via a one-page reporting form (for projects) or via an
informal email or phone call (for other CHP-related activities). In
addition to these actions, organizations may voluntarily apply for
recognition to the programs' established annual recognition events,
which require submitting additional information. EPA uses the data
obtained from its Partners to assess the success of these programs in
achieving their national energy and greenhouse gas (GHG) reduction
goals. Partners are organizational entities that have volunteered to
participate in either Partnership program.
    Respondents/affected entities: Entities potentially affected by
this action are company, institutional, and public-sector organizations
that voluntarily participate in the EPA's Green Power Partnership (GPP)
or Combined Heat and Power Partnership (CHPP). These include both
service and goods providing industries, educational institutions and
non-governmental organizations, commercial and industrial
organizations, and local, state, or federal government agencies.
    Forms: EPA-430-K-013, EPA-430-F-05-034; EPA-5900-353.
    Respondent's obligation to respond: Voluntary.
    Estimated number of respondents: 6,871 (total).
    Frequency of response: Annually, on occasion, one time.
    Total estimated burden: 6,598 hours (per year). Burden is defined
at 5 CFR 1320.03(b).
    Total estimated cost: $731,382 (per year), includes annualized
capital or operation & maintenance costs.
    Changes in estimates: There is minimal decrease in hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. Since the last ICR renewal, both the GPP and CHPP have
introduced program efficiencies to reduce program burden and simplified
collection forms into pre-populated spreadsheets or documents. As a
result of these changes, the average number of hours per Partner has
decreased from 3.2 hours to 2.87 hours, but the total hourly burden for
Partners still increased because of an increase in the number of
Partners. For perspective on the magnitude of Partner growth, the
number of Partners at the end of 2008 was 1,308, whereas by year-end
2018 there was an estimated 1959 (GPP has 1546, and CHP has 413). The
previous ICR also overestimated the growth of both programs and as
such, the out year's number of respondents was larger than the program
actually achieved. The GPP program is also re-evaluating program
requirements which may have an impact on the number of respondents in
the future. EPA will update the estimated respondent burden before
submission to OMB for review.

    Dated: September 4, 2018.
Carolyn Snyder,
Director, Climate Protection Partnership Division.
[FR Doc. 2018-20036 Filed 9-13-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 217 (Friday, November 8, 2013)]
[Rules and Regulations]
[Page 67024]
[FR Doc No: 2013-26717]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Parts 71

[Docket FAA No. FAA-2013-0529; Airspace Docket No. 13-ANM-17]

Establishment of Class E Airspace; Glasgow, MT

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule; correction.

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SUMMARY: This action corrects a final rule published in the Federal
Register of September 30, 2013, that establishes Class E airspace at
the Glasgow VHF Omni-Directional Radio Range/Distance Measuring
Equipment (VOR/DME) navigation aid, Glasgow, MT. A favorable comment
from the National Business Aviation Association (NBAA) was received in
the public Docket but was not referenced in the Final Rule.

DATES: Effective date: 0901 UTC, December 12, 2013. The Director of the
Federal Register approves this incorporation by reference action under
1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and
publication of conforming amendments.

FOR FURTHER INFORMATION CONTACT: Eldon Taylor, Federal Aviation
Administration, Operations Support Group, Western Service Center, 1601
Lind Avenue SW., Renton, WA 98057; telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

History

    The FAA published a final rule in the Federal Register establishing
Class E airspace at the Glasgow VOR/DME navigation aid, Glasgow, MT (78
FR 59807, September 30, 2013). The FAA received a comment in support of
the rule from the NBAA for inclusion in FAA Docket No. FAA-2013-0529
prior to the closing of the comment period. However, the preamble
incorrectly references that there were no comments to the proposal.
This action corrects that statement.

Correction to Final Rule

    Accordingly, pursuant to the authority delegated to me, the
description under the History heading, as published in the Federal
Register of September 30, 2013 (78 FR 59807), Airspace Docket No. 13-
ANM-17, FR Doc. 2013-23669, is corrected as follows: On page 59808,
column 1, line 4, remove the words ``No comments were received.'', and
add in their place ``One comment was received from the National
Business Aviation Association fully supporting the establishment of
Class E en route airspace.''.

    Issued in Seattle, Washington, on October 30, 2013.
Clark Desing,
Manager, Operations Support Group, Western Service Center.
[FR Doc. 2013-26717 Filed 11-7-13; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: November 18, 2010 (Volume 75, Number 222)]
[Notices]
[Page 70672-70673]
[DOCID:fr18no10-22]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPPT-2003-0004; FRL-8852-9]

Access to Confidential Business Information by Computer Sciences
Corporation and Its Identified Subcontractors

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: EPA has authorized its contractor, Computer Sciences
Corporation (CSC) of Chantilly, VA and Its Identified Subcontractors,
to access information which has been submitted to EPA under all
sections of the Toxic Substances Control Act (TSCA). Some of the
information may be claimed or determined to be Confidential Business
Information (CBI).

DATES: Access to the confidential data will occur no sooner than
November 26, 2010.

FOR FURTHER INFORMATION CONTACT: For technical information contact:
Pamela Moseley, Information Management Division (7407M), Office of
Pollution Prevention and Toxics, Environmental Protection Agency, 1200
Pennsylvania Ave., NW., Washington, DC 20460-

0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>; e-
mail address<EMAIL_ADDRESS>    For general information contact: The TSCA-Hotline, ABVI-Goodwill,
422 South Clinton Ave., Rochester, NY 14620; telephone number: (202)
554-1404; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this notice apply to me?

    This action is directed to the public in general. This action may,
however, be of interest to all who manufacture, process, or distribute
industrial chemicals. Since other entities may also be interested, the
Agency has not attempted to describe all the specific entities that may
be affected by this action. If you have any questions regarding the
applicability of this action to a particular entity, consult the
technical person listed under FOR FURTHER INFORMATION CONTACT.

B. How can I get copies of this document and other related information?

    EPA has established a docket for this action under docket
identification (ID) number EPA-HQ-OPPT-2003-0004. All documents in the
docket are listed in the docket index available at http://
www.regulations.gov. 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, will be publicly available only in hard copy. Publicly
available docket materials are available electronically at http://
www.regulations.gov, or, if only available in hard copy, at the OPPT
Docket. The OPPT Docket is located in the EPA Docket Center (EPA/DC) at
Rm. 3334, EPA West Bldg., 1301 Constitution Ave., NW., Washington, DC.
The EPA/DC Public Reading Room hours of operation are 8:30 a.m. to 4:30
p.m., Monday through Friday, excluding legal holidays. The telephone
number of the EPA/DC Public Reading Room is<PHONE_NUMBER>, and the
telephone number for the OPPT Docket is<PHONE_NUMBER>. Docket visitors
are required to show photographic identification, pass through a metal
detector, and sign the EPA visitor log. All visitor bags are processed
through an X-ray machine and subject to search. Visitors will be
provided an EPA/DC badge that must be visible at all times in the
building and returned upon departure.

II. What action is the agency taking?

    Under EPA contract number GS-35F-4381G, Task Order Number 1659,
contractors CSC of 15000 Conference Center Drive, Chantilly, VA; Apex
Systems, Inc. of 4000 W. Chase Blvd, Suite 450, Raleigh, NC; Excel
Management Systems of 691 N. High Street, 2nd Floor, Columbus, OH;
KForce of 950 Herndon Parkway, Suite 360, Herndon, VA; ITM Associates,
Inc. of 1700 Rockville Pike, Suite 350, Rockville, MD; and TEK Systems
of 7437 Race Road, 2nd Floor, Hanover, MD will assist the Office of
Pollution Prevention and Toxics (OPPT) in routine system administration
(SA) and database administration (DBA) as required to support OPPT
computer applications; OPPT staff; and their development staff.
Specific types of duties will be configuration changes; assistance in
backups/restoration of data; installation of operating system
maintenance; database maintenance; troubleshooting problems; and
security fixes. Routine performance of these duties does not require
access to TSCA CBI data.
    In accordance with 40 CFR 2.306(j), EPA has determined that under
EPA contract number GS-35F-4381G, Task Order Number 1659, CSC and Its
Identified Subcontractors will require access to CBI submitted to EPA
under all sections of TSCA to perform successfully the duties specified
under the contract. CSC and Its Identified Subcontractors' personnel
will be given access to information submitted to EPA under all sections
of TSCA. Some of the information may be claimed or determined to be
CBI.
    EPA is issuing this notice to inform all submitters of information
under all sections of TSCA that EPA may provide CSC and Its Identified
Subcontractors access to these CBI materials on a need-to-know basis
only. All access to TSCA CBI under this contract will take place at EPA
Headquarters and the Research Triangle Park facilities in accordance
with EPA's TSCA CBI Protection Manual.
    Access to TSCA data, including CBI, will continue until September
30, 2016. If the contract is extended, this access will also continue
for the duration of the extended contract without further notice.
    CSC and Its Identified Subcontractors' personnel will be required
to sign nondisclosure agreements and will be briefed on appropriate
security procedures before they are permitted access to TSCA CBI.

List of Subjects

    Environmental protection, Confidential business information.

    Dated: November 2, 2010.
Matthew Leopard,
Director, Information Management Division, Office of Pollution
Prevention and Toxics.
[FR Doc. 2010-29140 Filed 11-17-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 87, Number 176 (Tuesday, September 13, 2022)]
[Rules and Regulations]
[Pages 55907-55915]
[FR Doc No: 2022-19736]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 20 and 720

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

Public Information

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

ACTION: Final rule.

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

DATES: This rule is effective October 13, 2022.

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

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

SUPPLEMENTARY INFORMATION:

Table of Contents

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

I. Executive Summary

A. Purpose of the Final Rule

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

B. Summary of the Major Provisions of the Final Rule

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

C. Legal Authority

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

D. Costs and Benefits

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

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

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

III. Background

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

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

IV. Legal Authority

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

V. Comments on the Proposed Rule and FDA Response

A. Introduction

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

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

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

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

C. Description of Comments Outside the Scope of This Rulemaking

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

VI. Description of the Final Rule

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

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

VII. Effective Date

    This rule is effective October 13, 2022.

VIII. Economic Analysis of Impacts

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

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

IX. Analysis of Environmental Impact

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

X. Paperwork Reduction Act of 1995

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

XI. Federalism

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

XII. Consultation and Coordination With Indian Tribal Governments

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

List of Subjects

21 CFR Part 20

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

21 CFR Part 720

    Confidential business information, Cosmetics.

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

PART 20--PUBLIC INFORMATION

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

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

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

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

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

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

Sec.  20.22   Partial disclosure of records.

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

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

Sec.  20.26   Electronic availability and indexes of certain records.

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

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

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

Sec.  20.33   Form or format of response.

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

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

Sec.  20.40   Filing a request for records.

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

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

Sec.  20.41   Time limitations.

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

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

Sec.  20.44   Expedited processing.

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

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

Sec.  20.45   Fees to be charged.

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

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

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

Sec.  20.49   Denial of a request for records.

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

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

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

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

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

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

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

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

Sec.  20.82   Discretionary disclosure by the Commissioner.

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

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

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

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

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

Sec.  20.86   Disclosure in administrative or court proceedings.

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

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

Sec.  20.88   Communications with State and local government officials.

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

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

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

Sec.  20.89   Communications with foreign government officials.

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

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

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

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

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

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

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

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

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

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

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

Sec.  720.8   Confidentiality of statements.

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

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