[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48667-48669]
[FR Doc No: 2022-17147]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-1393]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Patent Term Restoration; Due Diligence Petitions;
Filing, Format, and Content of Petitions

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(PRA), Federal Agencies are required to publish notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information, and
to allow 60 days for public comment in response to the notice. This
notice solicits comments on information collection provisions found in
our Patent Term Restoration regulations.

DATES: Either electronic or written comments on the collection of
information must be submitted by October 11, 2022.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 11, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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-2013-N-1393 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Patent Term Restoration; Due
Diligence Petitions; Filing, Format, and Content of Petitions.''
Received comments, those filed in a timely manner (see ADDRESSES), 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>.

FOR FURTHER INFORMATION CONTACT: Rachel Showalter, Office of
Operations, Food and Drug Administration, Three White Flint North, 10A-
12M, 11601 Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA'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 respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.

Patent Term Restoration; Due Diligence Petitions; Filing, Format, and
Content of Petitions--21 CFR Part 60

OMB Control Number 0910-0233--Extension

    This information collection supports Agency regulations. FDA's
patent extension activities are conducted under the authority of
section 505(j) of the Federal, Food, Drug, and Cosmetic Act (the FD&C
Act) (21 U.S.C. 355(j)) and the Generic Animal Drug and Patent Term
Restoration Act of 1988 ((Pub. L. 100-670) (21 U.S.C. 301 et seq)). The
regulations are codified in part 60 (21 CFR part 60), Patent Term
Restoration. New human drug, animal drug, human biological, medical
device, food additive, or color additive products regulated by FDA must
undergo FDA safety, or safety and effectiveness review before marketing
is permitted. If the product is covered by a patent, part of the
patent's term may be consumed during this review, which diminishes the
value of the patent.
    In enacting section 505(j) of the FD&C Act and the Generic Animal
Drug and Patent Term Restoration Act of 1988, Congress sought to
encourage development of new, safer, and more effective medical and
food additive products. It did so by authorizing the U.S. Patent and
Trademark Office (USPTO) to extend the patent term by a portion of the
time during which FDA's safety and effectiveness review prevented
marketing of the product. The length of the patent term extension is
generally limited to a maximum of 5 years and is calculated by USPTO
based on a statutory formula. When a patent holder submits an
application for patent term extension to USPTO, USPTO requests
information from FDA, including the length of the regulatory review
period for the patented product. If USPTO concludes that the product is
eligible for patent term extension, FDA publishes a notice that
describes the length of the regulatory review period and the dates used
to calculate that period. Interested parties may request, under Sec.
60.24, revision of the length of the regulatory review period, or may
petition under Sec.  60.30 to reduce the regulatory review period by
any time where marketing approval was not pursued with ``due
diligence.''
    Section 60.36(a) defines due diligence as ``that degree of
attention, continuous directed effort, and timeliness as may reasonably
be expected from, and are ordinarily exercised by, a person during a
regulatory review period.'' As provided in Sec.  60.30(c), a due
diligence petition ``shall set forth sufficient facts, including dates
if possible, to merit an

investigation by FDA of whether the applicant acted with due
diligence.'' Upon receipt of a due diligence petition, FDA reviews the
petition and evaluates whether any change in the regulatory review
period is necessary. If so, the corrected regulatory review period is
published in the Federal Register. A due diligence petitioner not
satisfied with FDA's decision regarding the petition may, under Sec.
60.40, request an informal hearing for reconsideration of the due
diligence determination. Petitioners are likely to include persons or
organizations having knowledge that FDA's marketing permission for that
product was not actively pursued throughout the regulatory review
period. The information collection for which an extension of approval
is being sought is the use of the statutorily created due diligence
petition.
    During the calendar years 2019 through 2022, 15 requests for
revision of the regulatory review period were submitted under Sec.
60.24(a). In addition, a total of one due diligence petition was
submitted under Sec.  60.30. There have been no requests for hearings
under Sec.  60.40; however, for purposes of this information collection
approval, we estimate that we may receive one submission annually.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
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                                                     Number of
   21 CFR part 60--patent term       Number of     responses per   Total annual   Average burden    Total hours
           restoration              respondents     respondent       responses     per response
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60.24; revision of regulatory                  4            3.75              15             100           1,500
 review period determinations...
60.30; due diligence petitions..               1               1               1              50              50
60.40; due diligence hearings...               1               1               1              10              10
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           1,560
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Our estimated burden for the information collection reflects a
small decrease (-1 response) associated with submissions received under
Sec.  60.24 in previous years.

    Dated: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17147 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P


UNITED STATES OF AMERICA

DEPARTMENT OF TRANSPORTATION

OFFICE OF THE SECRETARY

WASHINGTON, DC

Issued by the Department of Transportation on December 27, 2006

   NOTICE OF ACTION TAKEN -- DOCKET OST-2000-7924

________________________________________________________________________
___________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Application of US AIRWAYS, INC. (US AIRWAYS) filed 11/3/06 for:

XX  Renewal of exemption under 49 U.S.C. 40109 to provide the following
service:

Scheduled foreign air transportation of persons, property, and mail
between a point or points in the United States and a point or points in
Belgium, and beyond.

Applicant rep: Howard Kass<PHONE_NUMBER>   DOT Analyst: Thuy H. Cooper
<PHONE_NUMBER>

D I S P O S I T I O N

XX  Granted (subject to conditions, see below)

The above action was effective when taken: December 27, 2006, through
December 27, 2008.

Action taken by:   Paul L. Gretch, Director

		      Office of International Aviation

XX  The authority is consistent with the aviation agreement between the
United States and Belgium.

Except to the extent exempted or waived, this authority is subject to
the terms, conditions, and limitations indicated:  	XX US Airways’
certificates of public convenience and necessity

	XX Standard exemption conditions (attached)

________________________________________________________________________
_______________________

On the basis of data officially noticeable under Rule 24(g) of the
Department's regulations, we found the applicant qualified to provide
the exemption services authorized.

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) our action was consistent with Department
policy; (2) grant of the authority was consistent with the public
interest; and (3) grant of the authority would not constitute a major
regulatory action under the Energy, Policy and Conservation Act of 1975.
 To the extent not granted, we denied all requests in the referenced
Docket.  We may amend, modify, or revoke the authority granted in this
Notice at any time without hearing at our discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR
§385.30, may file their petitions within seven (7) days after the date
of issuance of this Notice.  This action was effective when taken, and
the filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

APPENDIX

U.S. Carrier Exemption Conditions

In the conduct of the operations authorized, the U.S. carrier
applicant(s) shall:

(1)  Hold at all times effective operating authority from the government
of each country served;

(2)  Comply with applicable requirements concerning oversales contained
in 14 CFR 250 (for scheduled operations, if authorized);

(3)  Comply with the requirements for reporting data contained in 14 CFR
241;

(4)  Comply with requirements for minimum insurance coverage, and for
certifying that coverage to the Department, contained in 14 CFR 205;

(5)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR 203, concerning
waiver of Warsaw Convention liability limits and defenses;

(6)  Comply with all applicable requirements of the Federal Aviation
Administration, the Transportation Security Administration, and with all
applicable U.S. Government requirements concerning security, including,
but not limited to, 49 CFR Part 1544.  To assure compliance with all
applicable U.S. Government requirements concerning security, the holder
shall, before commencing any new service (including charter flights) to
or from a foreign airport, contact its International Principal Security
Inspector (IPSI) to advise the IPSI of its plans and to find out whether
the Transportation Security Administration has determined that security
is adequate to allow such airport(s) to be served; and

(7)  Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department of Transportation, with all applicable orders and regulations
of other U.S. agencies and courts, and with all applicable laws of the
United States.

The authority granted shall be effective only during the period when the
holder is in compliance with the conditions imposed above.

										  11/06

 US Airways states that it currently operates between the United States
and Belgium pursuant to a code-sharing relationship with United Air
Lines, Inc.


[Federal Register Volume 78, Number 235 (Friday, December 6, 2013)]
[Notices]
[Pages 73525-73534]
[FR Doc No: 2013-28983]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-9903-71-OSWER]

Comprehensive Environmental Response, Compensation and Liability
Act (CERCLA) or Superfund, Section 128(a); Notice of Grant Funding
Guidance for State and Tribal Response Programs for FY2014

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) will begin to accept
requests, from December 9, 2013 through January 31, 2014, for grants to
supplement State and Tribal Response Programs. This notice provides
guidance on eligibility for funding, use of funding, grant mechanisms
and process for awarding funding, the allocation system for
distribution of funding, and terms and reporting under these grants.
EPA has consulted with state and tribal officials in developing this
guidance.
    The primary goal of this funding is to ensure that state and tribal
response programs include, or are taking reasonable steps to include,
certain elements and a public record. Another goal is to provide
funding for other activities that increase the number of response
actions conducted or overseen by a state or tribal response program.
This funding is not intended to supplant current state or tribal
funding for their response programs. Instead, it is to supplement their
funding to increase their response capacity.
    For fiscal year 2014, EPA will consider funding requests up to a
maximum of $1.0 million per state or tribe. Subject to the availability
of funds, EPA regional personnel will be available to provide technical
assistance to states and tribes as they apply for and carry out these
grants.

DATES: This action is effective as of December 9, 2013. EPA expects to
make non-competitive grant awards to states and tribes which apply
during fiscal year 2014.

ADDRESSES: Mailing addresses for EPA Regional Offices and EPA
Headquarters can be located at www.epa.gov/brownfields and at the end
of this Notice.

FOR FURTHER INFORMATION CONTACT: EPA's Office of Solid Waste and
Emergency Response, Office of Brownfields and Land Revitalization,
(202) 566-2745 or the applicable EPA Regional Office listed at the end
this Notice.

SUPPLEMENTARY INFORMATION:

I. General Information

    Section 128(a) of the Comprehensive Environmental Response,
Compensation, and Liability Act (CERCLA), as amended, authorizes a
noncompetitive $50 million grant program to establish and enhance state
\1\ and tribal \2\ response programs. CERCLA 128(a) response program
grants are funded with categorical \3\ State and Tribal Assistance
Grant (STAG) appropriations. Section 128(a) cooperative agreements are
awarded and administered by the EPA regional offices. Generally, these
response programs address the assessment, cleanup, and redevelopment of
brownfields sites and other sites with actual or perceived
contamination. This document provides guidance that will enable states
and tribes to apply for and use fiscal year 2014 section 128(a)
funds.\4\
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    \1\ The term ``state'' is defined in this document as defined in
CERCLA section 101(27).
    \2\ The term ``Indian tribe'' is defined in this document as it
is defined in CERCLA section 101(36). Intertribal consortia, as
defined in the Federal Register Notice at 67 FR 67181, Nov. 4, 2002,
are also eligible for funding under CERCLA section 128(a).
    \3\ Categorical grants are issued by the U.S. Congress to fund
state and local governments for narrowly defined purposes.
    \4\ The Agency may waive any provision of this guidance that is
not required by statute, regulation, Executive Order or overriding
Agency policies.
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    The Catalogue of Federal Domestic Assistance entry for the section
128(a) State and Tribal Response Program cooperative agreements is
66.817. This grant program is eligible to be included in state and
tribal Performance Partnership Grants under 40 CFR part 35 Subparts A
and B, with the exception of funds used to capitalize a revolving loan
fund for brownfield remediation under section 104(k)(3); or purchase
insurance or develop a risk sharing pool, an indemnity pool, or
insurance mechanism to provide financing for response actions under a
State or Tribal response program.
    Requests for funding will be accepted from December 9, 2013 through
January 31, 2014. Requests EPA receives after January 31, 2014 will not
be considered for FY2014 funding. Information that must be submitted
with the funding request is listed in Section VIII of this guidance.
States or tribes that do not submit the request in the appropriate
manner may forfeit their ability to receive funds. First time
requestors are strongly encouraged to contact their Regional EPA
Brownfields contacts, listed at the end of this guidance, prior to
submitting their funding request.
    EPA will consider funding requests up to a maximum of $1.0 million
per state or tribe for FY2014.
    Requests submitted by the January 31, 2014 request deadline are
preliminary; final cooperative agreement work plans and budgets will be
negotiated with the regional offices once final funding allocation
determinations are made. As in previous years, EPA will place special
emphasis on reviewing a cooperative agreement recipient's use of prior
section 128(a) funding in making allocation decisions and unexpended
balances are subject to 40 CFR 35.118 and 40 CFR 35.518 to the extent
consistent with this guidance.
    States and tribes requesting funds are required to provide a Dun
and Bradstreet Data Universal Numbering System (DUNS) number with their
cooperative agreement's final package. For more information, please go
to www.grants.gov.

II. Background

    State and tribal response programs oversee assessment and cleanup
activities at brownfields sites across the country. The depth and
breadth of state and tribal response programs vary. Some focus on
CERCLA related activities, while others are multi-faceted, addressing
sites regulated by both CERCLA and the Resource Conservation and
Recovery Act (RCRA). Many state programs also offer accompanying
financial incentive programs to spur cleanup and redevelopment. In
enacting CERCLA

section 128(a),\5\ Congress recognized the accomplishments of state and
tribal response programs in cleaning up and redeveloping brownfields
sites. Section 128(a) provides EPA with an opportunity to strengthen
its partnership with states and tribes, and recognizes the response
programs' critical role in overseeing cleanups enrolled in their
response programs.
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    \5\ Section 128(a) was added to CERCLA in 2002 by the Small
Business Liability Relief and Brownfields Revitalization Act
(Brownfield Amendments).
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    This funding is intended for those states and tribes that have the
management and administrative capacity within their government required
to administer a federal grant. The primary goal of this funding is to
ensure that state and tribal response programs include, or are taking
reasonable steps to include, certain elements of an environmental
response program and that the response program establishes and
maintains a public record of sites addressed.
    Subject to the availability of funds, EPA regional personnel will
be available to provide technical assistance to states and tribes as
they apply for and carry out section 128(a) cooperative agreements.

III. Eligibility for Funding

    To be eligible for funding under CERCLA section 128(a), a state or
tribe must:
    1. demonstrate that its response program includes, or is taking
reasonable steps to include, the four elements of a response program
described in Section V of this guidance; or be a party to a voluntary
response program Memorandum of Agreement (VRP MOA) \6\ with EPA; and
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    \6\ States or tribes that are parties to VRP MOAs and that
maintain and make available a public record are automatically
eligible for section 128(a) funding.
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    2. maintain and make available to the public a record of sites at
which response actions have been completed in the previous year and are
planned to be addressed in the upcoming year, see CERCLA section
128(b)(1)(C).

IV. Matching Funds/Cost-Share

    States and tribes are not required to provide matching funds for
cooperative agreements awarded under section 128(a), with the exception
of section 128(a) funds a state or tribe uses to capitalize a
Brownfields Revolving Loan Fund (RLF) under CERCLA section 104(k)(3).
There is a 20% cost share requirement for 128(a) funds used to
capitalize a RLF.

V. The Four Elements--Section 128(a)

    Section 128(a) recipients that do not have a VRP MOA with EPA must
demonstrate that their response program includes, or is taking
reasonable steps to include, the four elements. Achievement of the four
elements should be viewed as a priority. Section 128(a) authorizes
funding for activities necessary to establish and enhance the four
elements, and to establish and maintain the public record requirement.
    The four elements of a response program are described below:
    1. Timely survey and inventory of brownfields sites in state or
tribal land. EPA's goal in funding activities under this element is to
enable the state or tribe to establish or enhance a system or process
that will provide a reasonable estimate of the number, likely
locations, and the general characteristics of brownfields sites in
their state or tribal lands. EPA recognizes the varied scope of state
and tribal response programs and will not require states and tribes to
develop a ``list'' of brownfields sites. However, at a minimum, the
state or tribe should develop and/or maintain a system or process that
can provide a reasonable estimate of the number, likely location, and
general characteristics of brownfields sites within their state or
tribal lands. Inventories should evolve to a prioritization of sites
based on community needs, planning priorities, and protection of human
health and the environment. Inventories should be developed in direct
coordination with communities, and particular attention should focus on
those communities with limited capacity to compete for, and manage a
competitive brownfield assessment, revolving loan, or cleanup
cooperative agreement.
    Given funding limitations, EPA will negotiate work plans with
states and tribes to achieve this goal efficiently and effectively, and
within a realistic time frame. For example, many of EPA's Brownfields
Assessment cooperative agreement recipients conduct inventories of
brownfields sites in their communities or jurisdictions. EPA encourages
states and tribes to work with these cooperative agreement recipients
to obtain the information that they have gathered and include it in
their survey and inventory.
    2. Oversight and enforcement authorities or other mechanisms and
resources. EPA's goal in funding activities under this element is to
have state and tribal response programs that include oversight and
enforcement authorities or other mechanisms, and resources that are
adequate to ensure that:
    a. A response action will protect human health and the environment,
and be conducted in accordance with applicable laws; and
    b. The state or tribe will complete the necessary response
activities if the person conducting the response fails to complete the
necessary response (this includes operation and maintenance and/or
long-term monitoring activities).
    3. Mechanisms and resources to provide meaningful opportunities for
public participation.\7\ EPA's goal in funding activities under this
element is to have states and tribes include in their response program
mechanisms and resources for meaningful public participation, at the
local level, including, at a minimum:
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    \7\ States and tribes establishing this element may find useful
information on public participation on EPA's community involvement
Web site at http://www.epa.gov/superfund/community/policies.htm.
---------------------------------------------------------------------------

    a. Public access to documents and related materials that a state,
tribe, or party conducting the cleanup is relying on or developing to
make cleanup decisions or conduct site activities;
    b. Prior notice and opportunity for meaningful public comment on
cleanup plans and site activities, including the input into the
prioritization of sites; and
    c. A mechanism by which a person who is, or may be, affected by a
release or threatened release of a hazardous substance, pollutant, or
contaminant at a brownfields site--located in the community in which
the person works or resides--may request that a site assessment be
conducted. The appropriate state or tribal official must consider this
request and appropriately respond.
    4. Mechanisms for approval of a cleanup plan, and verification and
certification that cleanup is complete. EPA's goal in funding
activities under this element is to have states and tribes include in
their response program mechanisms to approve cleanup plans and to
verify that response actions are complete, including a requirement for
certification or similar documentation from the state, the tribe, or a
licensed site professional that the response action is complete.
Written approval by a state or tribal response program official of a
proposed cleanup plan is an example of an approval mechanism.

VI. Public Record Requirement

    In order to be eligible for section 128(a) funding, states and
tribes (including those with MOAs) must establish and maintain a public
record system, as described below, in order to

receive funds. The public record should be made available to provide a
mechanism for meaningful public participation (refer to Section V.3
above). Specifically, under section 128(b)(1)(C), states and tribes
must:
    1. Maintain and update, at least annually or more often as
appropriate, a record that includes the name and location of sites at
which response actions have been completed during the previous year;
    2. Maintain and update, at least annually or more often as
appropriate, a record that includes the name and location of sites at
which response actions are planned in the next year; and
    3. Identify in the public record whether or not the site, upon
completion of the response action, will be suitable for unrestricted
use. If not, the public record must identify the institutional controls
relied on in the remedy and include relevant information concerning the
entity that will be responsible for oversight, monitoring, and/or
maintenance of the institutional and engineering controls; and how the
responsible entity is implementing those activities (see Section VI.C).
    Section 128(a) funds may be used to maintain and make available a
public record system that meets the requirements discussed above.

A. Distinguishing the ``Survey and Inventory'' Element From the
``Public Record''

    It is important to note that the public record requirement differs
from the ``timely survey and inventory'' element described in the
``Four Elements'' section above. The public record addresses sites at
which response actions have been completed in the previous year or are
planned in the upcoming year. In contrast, the ``timely survey and
inventory'' element, described above, refers to identifying brownfields
sites regardless of planned or completed actions at the site.

B. Making the Public Record Easily Accessible

    EPA's goal is to enable states and tribes to make the public record
and other information, such as information from the ``survey and
inventory'' element, easily accessible. For this reason, EPA will allow
states and tribes to use section 128(a) funding to make the public
record, as well as other information, such as information from the
``survey and inventory'' element, available to the public via the
internet or other means. For example, the Agency would support funding
state and tribal efforts to include detailed location information in
the public record such as the street address, and latitude and
longitude information for each site.\8\ States and tribes should ensure
that all affected communities have appropriate access to the public
record by making it available on-line, in print at libraries, or at
other community gathering places.
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    \8\ For further information on data quality requirements for
latitude and longitude information, please see EPA's data standards
Web site available at http://iaspub.epa.gov/sor_internet/registry/datastds/findadatastandard/epaapproved/latitudelongitude.
---------------------------------------------------------------------------

    In an effort to reduce cooperative agreement reporting requirements
and increase public access to the public record, EPA encourages states
and tribes to place their public record on the internet. If a state or
tribe places the public record on the internet, maintains the
substantive requirements of the public record, and provides EPA with
the link to that site, EPA will, for purposes of cooperative agreement
funding only, deem the public record reporting requirement met.

C. Long-Term Maintenance of the Public Record

    EPA encourages states and tribes to maintain public record
information, including data on institutional controls, on a long term
basis (more than one year) for sites at which a response action has
been completed. Subject to EPA regional office approval, states or
tribes may include development and operation of systems that ensure
long term maintenance of the public record, including information on
institutional controls (such as ensuring the entity responsible for
oversight, monitoring, and/or maintenance of the institutional and
engineering controls is implementing those activities) in their work
plans.\9\
---------------------------------------------------------------------------

    \9\ States and tribes may find useful information on
institutional controls on the EPA's institutional controls Web site
at http://www.epa.gov/superfund/policy/ic/index.htm
---------------------------------------------------------------------------

VII. Use of Funding

A. Overview

    Section 128(a)(1)(B) describes the eligible uses of cooperative
agreement funds by states and tribes. In general, a state or tribe may
use funding to ``establish or enhance'' its response program.
Specifically, a state or tribe may use cooperative agreement funds to
build response programs that includes the four elements outline in
section 128(a)(2). Eligible activities include, but are not limited to,
the following:
     Developing legislation, regulations, procedures,
ordinances, guidance, etc. that establish or enhance the administrative
and legal structure of a response program;
     Establishing and maintaining the required public record
described in Section VI of this guidance;
     Operation, maintenance and long-term monitoring of
institutional controls and engineering controls;
     Conducting site-specific activities, such as assessment or
cleanup, provided such activities establish and/or enhance the response
program and are tied to the four elements. In addition to the
requirement under CERCLA section 128(a)(2)(C)(ii) to provide for public
comment on cleanup plans and site activities, EPA strongly encourages
states and tribes to seek public input regarding the priority of sites
to be addressed and solicit input from local communities, especially
potential environmental justice communities, communities with a health
risk related to exposure to hazardous waste or other public health
concerns, economically disadvantaged or remote areas, and communities
with limited experience working with government agencies. EPA will not
provide section 128(a) funds solely for assessment or cleanup of
specific brownfields sites; site-specific activities must be part of an
overall section 128(a) work plan that includes funding for other
activities that establish or enhance the four elements;
     Capitalizing a revolving loan fund (RLF) for brownfields
cleanup under CERCLA section 104(k)(3). These RLFs are subject to the
same statutory requirements and cooperative agreement terms and
conditions applicable to RLFs awarded under section 104(k)(3).
Requirements include a 20 percent match (can be in the form of a
contribution of money, labor, material, or services from a non-federal
source) on the amount of section 128(a) funds used for the RLF, a
prohibition on using EPA cooperative agreement funds for administrative
costs relating to the RLF, and a prohibition on using RLF loans or
subgrants for response costs at a site for which the recipient may be
potentially liable under section 107 of CERCLA. Other prohibitions
contained in CERCLA section 104(k)(4) also apply; and
     Purchasing environmental insurance or developing a risk-
sharing pool, indemnity pool, or insurance mechanism to provide
financing for response actions under a state or tribal response
program.

B. Uses Related to ``Establishing'' A State or Tribal Response Program

    Under CERCLA section 128(a), ``establish'' includes activities
necessary

to build the foundation for the four elements of a state or tribal
response program and the public record requirement. For example, a
state or tribal response program may use section 128(a) funds to
develop regulations, ordinances, procedures, guidance, and a public
record.

C. Uses Related to ``Enhancing'' A State or Tribal Response Program

    Under CERCLA section 128(a), ``enhance'' is related to activities
that add to or improve a state or tribal response program or increase
the number of sites at which response actions are conducted under a
state or tribal response program.
    The exact ``enhancement'' uses that may be allowable depend upon
the work plan negotiated between the EPA regional office and the state
or tribe. For example, regional offices and states or tribes may agree
that section 128(a) funds may be used for outreach and training
directly related to increasing awareness of its response program, and
improving the skills of program staff. It may also include developing
better coordination and understanding of other state response programs,
e.g., RCRA or Underground Storage Tanks (USTs). As another example,
states and tribal response programs enhancement activities can include
outreach to local communities to increase their awareness and knowledge
regarding the importance of monitoring engineering and institutional
controls. Other ``enhancement'' uses may be allowable as well.

D. Uses Related to Site-Specific Activities

1. Eligible Uses of Funds for Site-Specific Activities
    Site-specific assessment and cleanup activities should establish
and/or enhance the response program and be tied to the four elements.
Site-specific assessments and cleanups can be both eligible and
allowable if the activities is included in the work plan negotiated
between the EPA regional office and the state or tribe, but activities
must comply with all applicable laws and are subject to the following
restrictions:
    a. Section 128(a) funds can only be used for assessments or
cleanups at sites that meet the definition of a brownfields site at
CERCLA section 101(39). EPA encourages states and tribes to use site-
specific funding to perform assessment (e.g., phase II, supplemental
assessments and cleanup planning) and cleanup activities that will lead
more quickly to the reuse and redevelopment of sites, particularly
sites located in distressed, environmental justice, rural or tribal
communities. Furthermore, states and tribes that perform site-specific
activities should plan to directly engage with and involve the targeted
community in the project. For example, a Community Relations Plan (CRP)
could be developed to provide reasonable notice to the public about a
planned cleanup, as well as opportunities for the public to comment on
the cleanup. States and tribes should work towards securing additional
funding for site-specific activities by leveraging resources from other
sources such as businesses, non-profit organizations, education and
training providers, and/or federal, state, tribal, and local
governments;
    b. Absent EPA approval, no more than $200,000 per site assessment
can be funded with section 128(a) funds, and no more than $200,000 per
site cleanup can be funded with section 128(a) funds;
    c. Absent EPA approval, the state/tribe may not use funds awarded
under this agreement to assess and/or clean up sites owned or operated
by the recipient or held in trust by the United States Government for
the recipient; and
    d. Assessments and cleanups cannot be conducted at sites where the
state/tribe is a potentially responsible party pursuant to CERCLA
section 107, except:
     At brownfields sites contaminated by a controlled
substance as defined in CERCLA section 101(39)(D)(ii)(I); or
     When the recipient would satisfy all of the elements set
forth in CERCLA section 101(40) to qualify as a bona fide prospective
purchaser except that the date of acquisition of the property was on or
before January 11, 2002.
    Subgrants cannot be provided to entities that may be potentially
responsible parties (pursuant to CERCLA section 107) at the site for
which the assessment or cleanup activities are proposed to be
conducted, except:
    1. At brownfields sites contaminated by a controlled substance as
defined in CERCLA section 101(39)(D)(ii)(I); or
    2. When the recipient would satisfy all of the elements set forth
in CERCLA section 101(40) to qualify as a bona fide prospective
purchaser except that the date of acquisition of the property was on or
before January 11, 2002.
2. Limitations on the Amount of Funds Used for Site-Specific Activities
and Waiver Process
    States and tribes may use section 128(a) funds for site-specific
activities that improve state or tribal capacity but the amount
recipients may request for site-specific assessments and cleanups may
not generally exceed 50% of the total amount of funding.\10\ In order
for EPA to consider a waiver, the total amount of the site-specific
request may not exceed the recipient's total funding level for the
previous year. The funding request must include a brief justification
describing the reason(s) for spending more than 50% of an annual
allocation on site-specific activities. An applicant, when requesting a
waiver, must include the following information in the written
justification:
---------------------------------------------------------------------------

    \10\ Oversight of assessment and cleanup activities performed by
responsible parties (other than the state or tribe) does not count
toward the 50% limit.
---------------------------------------------------------------------------

     Total amount requested for site-specific activities;
     Percentage of the site-specific activities (assuming
waiver is approved) in the total budget;
     Site specific activities that will be covered by this
funding. If known, provide site specific information and describe how
work on each site contributes to the development or enhancement of your
state/tribal site response program. EPA recognizes the role of response
programs to develop and provide capacity in distressed, environmental
justice, rural or tribal communities, and encourages prioritization for
site-specific activities in those communities. Further explain how the
community will be (or has been) involved in prioritization of site work
and especially those sites where there is a potential or known
significant environmental impact to the community;
     An explanation of how this shift in funding will not
negatively impact the core programmatic capacity (i.e., the ability to
establish/enhance four elements of a response program) and how related
activities will be maintained in spite of an increase in site-specific
work. Recipients must demonstrate that they have adequate funding from
other sources to effectively carry out work on the four elements for
EPA to grant a waiver of the 50% limit on using 128(a) funds for site-
specific activities;
     As explanation as to whether the sites to be addressed are
those for which the affected community(ies) has requested work be
conducted (refer to Section VII.A Overview of Funding for more
information). EPA Headquarters will base approval of waivers on the
information that is included in the justification along with the
request for funding, as well as other information available to the
Agency. The EPA will then inform recipients of the Agency's final
decision(s).

3. Uses Related to Site-Specific Activities at Petroleum Brownfields
Sites
    States and tribes may use section 128(a) funds for activities that
establish and enhance response programs addressing petroleum brownfield
sites. Subject to the restrictions listed above (see Section VII.D.1)
for all site-specific activities, the costs of site-specific
assessments and cleanup activities at petroleum contaminated
brownfields sites, defined at CERCLA section 101(39)(D)(ii)(II), are
both eligible and allowable if the activity is included in the work
plan negotiated between the EPA regional office and the state or tribe.
Section 128(a) funds used to capitalize a Brownfields RLF may be used
at brownfields sites contaminated by petroleum to the extent allowed
under CERCLA section 104(k)(3).
4. Additional Examples of Eligible Site-Specific Activities
    Other eligible uses of funds for site-specific related include, but
are not limited to, the following activities:
     Technical assistance to federal brownfields cooperative
agreement recipients;
     Development and/or review of quality assurance project
plans (QAPPs); and
     Entering data into the ACRES database

E. Uses Related to Activities At ``Non-Brownfields'' Sites

    Costs incurred for activities at non-brownfields sites, e.g.,
oversight, may be eligible and allowable if such activities are
included in the state's or tribe's work plan. Other uses not
specifically referenced in this guidance may also be eligible and
allowable. Recipients should consult with their regional state or
tribal contact for additional guidance. Direct assessment and cleanup
activities may only be conducted on eligible brownfields sites, as
defined in CERCLA section 101(39).

VIII. General Programmatic Guidelines For 128(a) Grant Funding Requests

    Funding authorized under CERCLA section 128(a) is awarded through a
cooperative agreement \11\ between EPA and a state or a tribe. The
program is administered under the general EPA grant and cooperative
agreement regulations for states, tribes, and local governments found
in the Code of Federal Regulations at 40 CFR part 31 as well as
applicable provisions of 40 CFR Part 35 Subparts A and B. Under these
regulations, the cooperative agreement recipient for section 128(a)
grant program is the government to which a cooperative agreement is
awarded and which is accountable for the use of the funds provided. The
cooperative agreement recipient is the entire legal entity even if only
a particular component of the entity is designated in the cooperative
agreement award document. Further, unexpended balances of cooperative
agreement funds are subject to 40 CFR 35.118 and 40 CFR 35.518 to the
extent consistent with this guidance. EPA allocates funds to state and
tribal response programs under 40 CFR 35.420 and 40 CFR 35.737.
---------------------------------------------------------------------------

    \11\ A cooperative agreement is an agreement to a state/tribe
that includes substantial involvement by EPA on activities described
in the work plan which may include technical assistance,
collaboration on program priorities, etc.
---------------------------------------------------------------------------

A. One Application Per State or Tribe

    Subject to the availability of funds, EPA regional offices will
negotiate and enter into section 128(a) cooperative agreements with
eligible and interested states or tribes. EPA will accept only one
application from each eligible state or tribe.

B. Maximum Funding Request

    For Fiscal Year 2014, EPA will consider funding requests up to a
maximum of $1.0 million per state or tribe. Please note the CERCLA
128(a) program's annual budget has remained relatively the same since
2003 while demand has increased over time. Due to the increasing number
of entities requesting funding, it is likely that the FY14 states and
tribal individual funding amounts will be less than the FY13 individual
funding amounts.

C. Define the State or Tribal Response Program

    States and tribes must define in their work plan the ``section
128(a) response program(s)'' to which the funds will be applied, and
may designate a component of the state or tribe that will be EPA's
primary point of contact for negotiations on their proposed work plan.
When EPA funds the section 128(a) cooperative agreement, states and
tribes may distribute these funds among the appropriate state and
tribal agencies that are part of the section 128(a) response program.
This distribution must be clearly outlined in their annual work plan.

D. Separate Cooperative Agreements for the Capitalization of RLFs Using
Section 128(a) Funds

    If a portion of the section 128(a) grant funds requested will be
used to capitalize a revolving loan fund for cleanup, pursuant to
section 104(k)(3), two separate cooperative agreements must be awarded,
i.e., one for the RLF and one for non-RLF uses. States and tribes may,
however, submit one initial request for funding, delineating the RLF as
a proposed use. Section 128(a) funds used to capitalize an RLF are not
eligible for inclusion into a Performance Partnership Grant (PPG).

E. Authority To Manage a Revolving Loan Fund Program

    If a state or tribe chooses to use its section 128(a) funds to
capitalize a revolving loan fund program, the state or tribe must have
the lead authority to manage the program, e.g., hold loans, make loans,
enter into loan agreements, collect repayment, access and secure the
site in event of an emergency or loan default. If the agency/department
listed as the point of contact for the section 128(a) cooperative
agreement does not have this authority, it must be able to demonstrate
that another state or tribal agency does have the authority to manage
the RLF and is willing to do so.

F. Section 128(a) Cooperative Agreements Can Be Part of a Performance
Partnership Grant (PPG)

    States and tribes may include section 128(a) cooperative agreements
in their PPG 69 FR 51,756 (2004). Section 128(a) funds used to
capitalize an RLF or purchase insurance or develop a risk sharing pool,
an indemnity pool, or insurance mechanism to provide financing for
response actions under a state or tribal response program are not
eligible for inclusion in the PPG.

G. Project Period

    EPA regional offices will determine the project period for each
cooperative agreement. These may be for multiple years depending on the
regional office's cooperative agreement policies. Each cooperative
agreement must have an annual budget period tied to an annual work
plan. While not prohibited, pre-award costs are subject to 40 CFR
35.113 and 40 CFR 35.513.

H. Demonstrating the Four Elements

    As part of the annual work plan negotiation process, states or
tribes that do not have VRP MOAs must demonstrate that their program
includes, or is taking reasonable steps to include, the four elements
described in Section V. EPA will not fund, in future years, state or
tribal response program annual work plans if EPA determines that these
elements are not met or reasonable progress is not being made. EPA may
base this determination on the information the state or tribe provides
to support its work plan, on progress

reports, or on EPA's review of the state or tribal response program.

I. Establishing and Maintaining the Public Record

    Prior to funding a state's or tribe's annual work plan, EPA
regional offices will verify and document that a public record, as
described in Section VI and below, exists and is being maintained.\12\
Specifically for:
---------------------------------------------------------------------------

    \12\ For purposes of 128(a) funding, the state's or tribe's
public record applies to that state's or tribe's response program(s)
that utilized the section 128(a) funding.
---------------------------------------------------------------------------

     States or tribes that received initial funding prior to
FY13: Requests for FY14 funds will not be accepted from states or
tribes that fail to demonstrate, by the January 31, 2014 request
deadline, that they established and are maintaining a public record.
(Note, this would potentially impact any state or tribe that had a term
and condition placed on their FY13 cooperative agreement that
prohibited drawdown of FY13 funds prior to meeting public record
requirement). States or tribes in this situation will not be prevented
from drawing down their prior year funds once the public record
requirement is met; and
     States or tribes that received initial funding in FY13: By
the time of the actual FY14 award, the state or tribe must demonstrate
that they established and maintained the public record (those states
and tribes that do not meet this requirement will have a term and
condition placed on their FY14 cooperative agreement that prohibits the
drawdown of FY14 funds until the public record requirement is met).

J. Demonstration of Significant Utilization of Prior Years' Funding

    States and tribes should be aware that EPA and its Congressional
appropriations committees place significant emphasis on the utilization
of prior years' funding. Unused funds from prior years will be
considered in the allocation process. Existing balances of cooperative
agreement funds as reflected in EPA's Financial Data Warehouse could
support an allocation amount below a recipient's request for funding
or, if appropriate deobligation and reallocation by EPA Regions as
provided for in 40 CFR 35.118 and 40 CFR 35.518.
    EPA Regional staff will review EPA's Financial Database Warehouse
to identify the amount of remaining prior year(s) funds. The requestor
should work, as early as possible, with both their own finance
department, and with their Regional Project Officer to reconcile any
discrepancy between the amount of unspent funds showing in EPA's
system, and the amount reflected in the recipient's records. The
recipient should obtain concurrence from the Region on the amount of
unspent funds requiring justification by the deadline for this request
for funding.

K. Allocation System and Process for Distribution of Funds

    After the January 31, 2014, request deadline, EPA's Regional
Offices will submit summaries of state and tribal requests to EPA
Headquarters. Before submitting requests to EPA Headquarters, regional
offices may take into account additional factors when determining
recommended allocation amounts. Such factors include, but are not
limited to, the depth and breadth of the state or tribal program; scope
of the perceived need for the funding, e.g., size of state or tribal
jurisdiction or the proposed work plan balanced against capacity of the
program, amount of current year funding, funds remaining from prior
years, etc.
    After receipt of the regional recommendations, EPA Headquarters
will consolidate requests and make decisions on the final funding
allocations.
    EPA regional offices will work with interested states and tribes to
develop their preliminary work plans and funding requests. Final
cooperative agreement work plans and budgets will be negotiated with
the regional office once final allocation determinations are made.
Please refer to process flow chart below (dates are estimates and
subject to change):
[GRAPHIC] [TIFF OMITTED] TN06DE13.000

IX. Information To Be Submitted With the Funding Request

A. Summary of Planned Use of FY14 Funding

    All states and tribes requesting FY14 funds must submit (to their
regional brownfields contact) a summary of the planned use of the funds
with associated dollar amounts. Please provide the request in the chart
below. The amount of funding requested should be an amount that can be
reasonably spent in one year. It is likely that the FY14 state and
tribal individual funding amounts will be less than the FY13 individual
funding amounts. The requestor should work, as early as possible, with
their EPA Regional Program contact to ensure that the funding amount
requested and related activities are reasonable.

B. Demonstration of Significant Utilization of Prior Years' Funding

    States and tribes that received section 128(a) funds in prior years
must provide the amount of prior years' funding including funds that
recipients have not received in payments (i.e., funds EPA has obligated
for grants that remain in EPA's Financial Data Warehouse). EPA will
take into account these funds in the allocation process when
determining the recipient's programmatic needs under 40 CFR 35.420 and
40 CFR 35.737. The recipient should include a detailed explanation and
justification of prior year funds that remain in EPA's Financial Data
Warehouse as unspent balances. The recipient should obtain concurrence
from the Region on the amount of unspent funds requiring explanation by
the January 31, 2014

deadlines for submitting funding requests.

C. Optional: Explanation of Overall Program Impacts of Any Funding
Reductions

    Please explain the programmatic effects of a reduction (to your
current funding amount) on significant activities of your response
program. Specifically, at what amount (e.g., percentage of your current
funding level) would your response program experience core programmatic
impacts such as a reduction in staff, a decrease in oversight
activities, or other impacts to the environment and health of the
communities the program serves, etc.? An EPA Region may require that
this information be submitted as part of the request for funding in
order to fully understand the individual program impacts associated
with decreased funding. These impacts will be considered as part of the
decision for the final allocation.

----------------------------------------------------------------------------------------------------------------
                                                                               Summary of intended use  (Example
           Funding use                 FY13 Awarded         FY14 Requested                   Uses)
----------------------------------------------------------------------------------------------------------------
Establish or enhance the four      $XX,XXX.............  $XX,XXX............
 elements:.
    1. Timely survey and           ....................  ...................  1. Examples:
     inventory of brownfields
     sites;.
                                   ....................  ...................   inventory and prioritize
                                                                               brownfields sites.
                                   ....................  ...................   institutional control
                                                                               (IC)/engineering control (EC)
                                                                               tracking.
    2. Oversight and enforcement   ....................  ...................  2. Examples:
     authorities or other
     mechanisms;.
                                   ....................  ...................   develop/enhance
                                                                               ordinances, regulations,
                                                                               procedures for response programs.
    3. Mechanisms and resources    ....................  ...................  3. Examples:
     to provide meaningful
     opportunities for public
     participation;.
                                   ....................  ...................   develop a community
                                                                               involvement process.
                                   ....................  ...................   community outreach.
                                   ....................  ...................   issue public notices of
                                                                               site activities.
                                   ....................  ...................   develop a process to seek
                                                                               public input from local
                                                                               communities, especially potential
                                                                               environmental justice
                                                                               communities, communities with a
                                                                               health risk related to exposure
                                                                               to hazardous waste or other
                                                                               public health concerns,
                                                                               economically disadvantaged or
                                                                               remote areas, and communities
                                                                               with limited experience working
                                                                               with government agencies to
                                                                               prioritize sites to be addressed.
    4. Mechanisms or approval of   ....................  ...................  4. Examples:
     a cleanup plan and
     verification and
     certification that cleanup
     is complete.
                                   ....................  ...................   Develop/update cleanup
                                                                               standards.
                                   ....................  ...................   review cleanup plans and
                                                                               verify completed actions.
Establish and maintain the public  $XX,XXX.............  $XX,XXX............   maintain public record.
 record.
                                   ....................  ...................   create web site for
                                                                               public record.
                                   ....................  ...................   disseminate public
                                                                               information on how to access the
                                                                               public record.
Enhance the response program.....  $XX,XXX.............  $XX,XXX............   provide oversight of site
                                                                               assessments and cleanups.
                                   ....................  ...................   attend training and
                                                                               conferences on brownfields
                                                                               cleanup technologies & other
                                                                               brownfields topics.
                                   ....................  ...................   update and enhance
                                                                               program management activities.
                                   ....................  ...................   negotiate/oversee
                                                                               contracts for response programs.
                                   ....................  ...................   enhance program
                                                                               management & tracking systems.
Site-specific activities (amount   $XX,XXX.............  $XX,XXX............   perform site assessments
 requested should be incidental                                                and cleanups.
 to the workplan, see Section                                                  develop QAPPs.
 VI.D for more information on                                                  establish eligibility of
 what activities should be                                                     target sites.
 considered when calculating site                                              prepare Property Profile
 specific activities).                                                         Forms/input data into ACRES
                                                                               database for these sites.
Environmental insurance..........  $XX,XXX.............  $XX,XXX............   review potential uses of
                                                                               environmental insurance.
                                   ....................  ...................   manage an insurance risk
                                                                               pool.
Revolving loan fund..............  $XX,XXX.............  $XX,XXX............   create a cleanup
                                                                               revolving loan fund.
Total funding....................  $XXX,XXX............  $XXX,XXX...........  Performance Partnership Grant? Yes
                                                                               [ballot] No [ballot].
----------------------------------------------------------------------------------------------------------------

X. Terms and Reporting

    Cooperative agreements for state and tribal response programs will
include programmatic and administrative terms and conditions. These
terms and conditions will describe EPA's substantial involvement
including technical assistance and collaboration on program development
and site-specific activities. Each of the subsections below summarizes
the basic terms and conditions, and related reporting that will be
required if a cooperative agreement with EPA is awarded.

A. Progress Reports

    In accordance with 40 CFR 31.40, state and tribes must provide
progress reports as provided in the terms and conditions of the
cooperative agreement negotiated with EPA regional offices. State and
tribal costs for complying with reporting requirements are an eligible
expense under the section 128(a)

cooperative agreement. As a minimum, state or tribal progress reports
must include both a narrative discussion and performance data relating
to the state's or tribe's accomplishments and environmental outputs
associated with the approved budget and workplan. Reports should also
provide an accounting of section 128(a) funding. If applicable, the
state or tribe must include information on activities related to
establishing or enhancing the four elements of the state's or tribe's
response program. All recipients must provide information related to
establishing or, if already established, maintaining the public record.
Depending upon the activities included in the state's or tribe's work
plan, an EPA regional office may request that a progress report
include:
    1. Reporting interim and final progress reports. Reports must
prominently display the following three relevant Essential Elements as
reflected in the current EPA strategic plan: Strategic Plan Goal 3:
Cleaning Up Communities and Advancing Sustainable Development,
Strategic Plan Objective 3.1: Promote Sustainable and Livable
Communities, and Work plan Commitments and Timeframes. EPA's strategic
plan can be found on the Internet at http://www.epa.gov/planandbudget/strategicplan.html.
    2. Reporting for Non-MOA states and tribes. All recipients without
a VRP MOA must report activities related to establishing or enhancing
the four elements of the state's or tribe's response program. For each
element state/tribes must report how they are maintaining the element
or how they are taking reasonable steps to establish or enhance the
element as negotiated in individual state/tribal work plans. For
example, pursuant to CERCLA section 128(a)(2)(B), reports on the
oversight and enforcement authorities/mechanisms element may include:
     A narrative description and copies of applicable documents
developed or under development to enable the response program to
conduct enforcement and oversight at sites. For example:
    [cir] Legal authorities and mechanisms (e.g., statutes,
regulations, orders, agreements); and
    [cir] Policies and procedures to implement legal authorities; and
other mechanisms;
     A description of the resources and staff allocated/to be
allocated to the response program to conduct oversight and enforcement
at sites as a result of the cooperative agreement;
     A narrative description of how these authorities or other
mechanisms, and resources, are adequate to ensure that:
    [cir] A response action will protect human health and the
environment; and be conducted in accordance with applicable federal and
state law; and if the person conducting the response action fails to
complete the necessary response activities, including operation and
maintenance or long-term monitoring activities, the necessary response
activities are completed; and
     A narrative description and copy of appropriate documents
demonstrating the exercise of oversight and enforcement authorities by
the response program at a brownfields site.
    3. Reporting for site-specific assessment or cleanup activities.
Recipients with work plans that include funding for brownfields site
assessment or cleanup must input information required by the OMB-
approved Property Profile Form into the Assessment Cleanup and
Redevelopment Exchange System (ACRES) database for each site assessment
and cleanup. In addition, recipients must report how they provide the
affected community with prior notice and opportunity for meaningful
participation as per CERCLA section 128(a)(2)(C)(ii), on proposed
cleanup plans and site activities. For example, EPA strongly encourages
states and tribes to seek public input regarding the priority of sites
to be addressed and to solicit input from local communities, especially
potential environmental justice communities, communities with a health
risk related to exposure to hazardous waste or other public health
concerns, economically disadvantaged or remote communities, and
communities with limited experience working with government agencies.
    4. Reporting for other site-specific activities. Recipients with
work plans that include funding for other site-specific related
activities must include a description of the site-specific activities
and the number of sites at which the activity was conducted. For
example:
     Number and frequency of oversight audits of licensed site
professional certified cleanups;
     Number and frequency of state/tribal oversight audits
conducted;
     Number of sites where staff conducted audits, provided
technical assistance, or conducted other oversight activities; and
     Number of staff conducting oversight audits, providing
technical assistance, or conducting other oversight activities.
    5. Reporting required when using funding for an RLF. Recipients
with work plans that include funding for revolving loan fund (RLF) must
include the information required by the terms and conditions for
progress reporting under CERCLA section 104(k)(3) RLF cooperative
agreements.
    6. Reporting environmental insurance. Recipients with work plans
that include funding for environmental insurance must report:
     Number and description of insurance policies purchased
(e.g., type of coverage provided; dollar limits of coverage; any
buffers or deductibles; category and identity of insured persons;
premium; first dollar or umbrella; site specific or blanket; occurrence
or claims made, etc.);
     The number of sites covered by the insurance;
     The amount of funds spent on environmental insurance
(e.g., amount dedicated to insurance program, or to insurance
premiums); and
     The amount of claims paid by insurers to policy holders.
    The regional offices may also request that information be added to
the progress reports, as appropriate, to properly document activities
described by the cooperative agreement work plan.
    EPA regions may allow states or tribes to provide performance data
in appropriate electronic format.
    The regional offices will forward progress reports to EPA
Headquarters, if requested. This information may be used to develop
national reports on the outcomes of CERCLA section 128(a) funding to
states and tribes.

B. Reporting of Program Activity Levels

    States and tribes must report, by January 31, 2014, a summary of
the previous federal fiscal year's work (October 1, 2012 through
September 30, 2013). The following information must be submitted to
your regional project officer:
     Environmental programs where CERCLA 128(a) funds are used
to support capacity building (general program support, non-site-
specific work). Indicate as appropriate from the following:

--Brownfields
--Underground Storage Tanks/Leaking Underground Storage Tanks
--Federal Facilities
--Solid Waste
--Superfund
--Hazardous Waste Facilities
--VCP (Voluntary Cleanup Program, Independent Cleanup Program, etc.)
--Other----------------;

     Number of properties (or sites) enrolled in a response
program during FY13;
     Number of properties (or sites) where documentation
indicates that

cleanup work is complete and all required institutional controls (IC's)
are in place, or not required;
     Total number of acres associated with properties (or
sites) in the previous bullet; and
     Number of properties where assistance was provided, but
the property was not enrolled in the response program (OPTIONAL).
    EPA may require states/tribes to report specific performance
measures related to the four elements that can be aggregated for
national reporting to Congress.
    For example:
    1. Timely survey and inventory--estimated number of brownfields
sites in the state or on tribal land;
    2. oversight and enforcement authorities/mechanisms--number of
active cleanups and percentage that received oversight; percentage of
active cleanups not in compliance with the cleanup workplan and that
received communications from recipient regarding non-compliance;
    3. public participation--percentage of sites in the response
program where public meetings/notices were conducted regarding the
cleanup plan and/or other site activities; number of site assessments
requests, and responses to such requests; and
    4. cleanup approval/certification mechanisms--total number of ``no
further action'' letters or total number of certificates of
completions.
    [NOTE: This reporting requirement may include activities not funded
with CERCLA Section 128(a) funding, because such information may be
helpful to EPA when evaluating whether recipients have met or are
taking reasonable steps to meet the four elements of a response program
pursuant to CERCLA Section 128(a)(2).]

C. Reporting of Public Record

    All recipients must report, as specified in the terms and
conditions of their cooperative agreement, and in Section VIII.I of
this guidance, information related to establishing, or if already
established, maintaining the public record, described above. States and
tribes can refer to an already existing public record, e.g., Web site
or other public database to meet the public record requirement.
Recipients reporting may only be required to demonstrate that the
public record (a) exists and is up-to-date, and (b) is adequate. A
public record may include the following information:
    A list of sites at which response actions have been completed in
the past year including:
     Date the response action was completed;
     Site name;
     Name of owner at time of cleanup, if known;
     Location of the site (street address, and latitude and
longitude);
     Whether an institutional control is in place;
     Type of institutional control in place (e.g., deed
restriction, zoning restriction, local ordinance, state registries of
contaminated property, deed notices, advisories, etc.);
     Nature of the contamination at the site (e.g., hazardous
substances, contaminants or pollutants, petroleum contamination, etc.);
and
     Size of the site in acres.
    A list of sites planned to be addressed by the state or tribal
response program in the coming year including:
     Site name and the name of owner at time of cleanup, if
known;
     Location of the site (street address, and latitude and
longitude);
     To the extent known, whether an institutional control is
in place;
     Type of the institutional control in place (e.g., deed
restriction, zoning restriction, local ordinance, state registries of
contaminated property, deed notices, advisories, etc.);
     To the extent known, the nature of the contamination at
the site (e.g., hazardous substances, contaminants, or pollutants,
petroleum contamination, etc.); and
     Size of the site in acres

D. Award Administration Information

1. Subaward and Executive Compensation Reporting
    Applicants must ensure that they have the necessary processes and
systems in place to comply with the subaward and executive total
compensation reporting requirements established under OMB guidance at 2
CFR part 170, unless they qualify for an exception from the
requirements, should they be selected for funding.
2. System for Award Management (SAM) and Data Universal Numbering
System (DUNS) Requirements
    Unless exempt from these requirements under OMB guidance at 2 CFR
Part 25(e.g., individuals), applicants must:
    1. Be registered in SAM prior to submitting an application or
proposal under this announcement. SAM information can be found at
https://www.sam.gov/portal/public/SAM/.
    2. Maintain an active SAM registration with current information at
all times during which it has an active Federal award or an application
or proposal under consideration by an agency, and
    3. Provide its DUNS number in each application or proposal it
submits to the agency. Applicants can receive a DUNS number, at no
cost, by calling the dedicated toll-free DUNS Number request line at 1-
866-705-5711, or visiting the D&B Web site at: http://www.dnb.com.
    If an applicant fails to comply with these requirements, it will,
should it be selected for award, affect their ability to receive the
award.
    Please note that the CCR has been replaced by the System for Award
Management (SAM). To learn more about SAM, go to SAM.gov or https://www.sam.gov/portal/public/SAM/.
3. Use of Funds
    An applicant that receives an award under this announcement is
expected to manage assistance agreement funds efficiently and
effectively, and make sufficient progress towards completing the
project activities described in the work-plan in a timely manner. The
assistance agreement will include terms and conditions related to
implementing this requirement.

             Regional State and Tribal Brownfields Contacts
------------------------------------------------------------------------
             Region                      State              Tribal
------------------------------------------------------------------------
1--CT, ME, MA, NH, RI, VT.......  James Byrne, 5      Amy Jean McKeown,
                                   Post Office         5 Post Office
                                   Square, Suite       Square, Suite 100
                                   100, (OSRR07-2),    (OSRR07-2),
                                   Boston, MA 02109-   Boston, MA 02109-
                                   3912, Phone (617)   3912, Phone (617)
                                   918-1389 Fax        918-1248 Fax
<PHONE_NUMBER>.<PHONE_NUMBER>.
2--NJ, NY, PR, VI...............  Alison Devine, 290  Phillip Clappin,
                                   Broadway, 18th      290 Broadway,
                                   Floor, New York,    18th Floor, New
                                   NY 10007-1866,      York, NY 10007-
                                   Phone (212) 637-    1866, Phone (212)
                                   4158 Fax<PHONE_NUMBER> Fax
                                   637-3083.<PHONE_NUMBER>.
3--DE, DC, MD, PA, VA, WV.......  Janice Bartel,
                                   1650 Arch Street
                                   (3HS51),
                                   Philadelphia, PA
                                   19103, Phone
<PHONE_NUMBER>
                                   Fax (215) 814-
                                   3015.

4--AL, FL, GA, KY, MS, NC, SC,    Nicole Comick-      Cindy J. Nolan, 61
 TN.                               Bates, 61 Forsyth   Forsyth Street,
                                   Street, S.W, 10TH   S.W, 10TH FL
                                   FL (9T25),          (9T25), Atlanta,
                                   Atlanta, GA 30303-  GA 30303-8909,
                                   8909, Phone (404)   Phone (404) 562-
                                   562-9966 Fax        8425 Fax (404)
<PHONE_NUMBER>.     562-8788.
5--IL, IN, MI, MN, OH, WI.......  Jan Pels, 77 West   Jane Neumann, 77
                                   Jackson Boulevard   West Jackson
                                   (SE-7J), Chicago,   Boulevard (SE-
                                   IL 60604-3507,      7J), Chicago, IL
                                   Phone (312) 886-    60604-3507, Phone
                                   3009 Fax (312)<PHONE_NUMBER>
                                   692-2161.           Fax (312) 697-
                                                       2649.
6--AR, LA, NM, OK, TX...........  Amber Perry, 1445   Amber Perry, 1445
                                   Ross Avenue,        Ross Avenue,
                                   Suite 1200 (6SF),   Suite 1200 (6SF),
                                   Dallas, TX 75202-   Dallas, TX 75202-
                                   2733, Phone (214)   2733, Phone (214)
                                   665-3172 Fax        665-3172 Fax
<PHONE_NUMBER>.<PHONE_NUMBER>.
7--IA, KS, MO, NE...............  Susan Klein, 11201  Jennifer Morris,
                                   Renner Boulevard    11201 Renner
                                   (SUPRSTAR),         Boulevard
                                   Lenexa, KS 66219,   (SUPRSTAR),
                                   Phone (913) 551-    Lenexa, KS 66219,
                                   7786 Fax (913)      Phone (913) 551-
                                   551-9786.           7341Fax (913) 551-
                                                       9798.
8--CO, MT, ND, SD, UT, WY.......  Christina Wilson,   Barbara Benoy,
                                   1595 Wynkoop        1595 Wynkoop
                                   Street (EPR-B),     Street (8EPR-SA),
                                   Denver, CO 80202-   Denver, CO 80202-
                                   1129, Phone (303)   1129, Phone (303)
                                   312-6706 Fax        312-6760 Fax
<PHONE_NUMBER>.<PHONE_NUMBER>.
9--AZ, CA, HI, NV, AS, GU.......  Eugenia Chow, 75    Glenn Kistner, 75
                                   Hawthorne St.       Hawthorne St.
                                   (SFD-6-1), San      (SFD-6-1), San
                                   Francisco, CA       Francisco, CA
                                   94105, Phone        94105, Phone
<PHONE_NUMBER><PHONE_NUMBER>
                                   Fax (415) 947-      Fax (415) 947-
                                   3520.               3520.
10--AK, ID, OR, WA..............  Mary K. Goolie,     Mary K. Goolie,
                                   222 West 7th        222 West 7th
                                   Avenue 19 (AOO),         i>19 (AOO),
                                   Anchorage, AK       Anchorage, AK
                                   99513, Phone        99513, Phone
                                   ((907) 271-3414     ((907) 271-3414
                                   Fax ( 907) 271-     Fax (907) 271-
                                   3424.               3424.
------------------------------------------------------------------------

XI. Statutory and Executive Order Reviews

    Under Executive Order 12866 (58 FR 51735, October 4, 1993), this
action is not a ``significant regulatory action'' and is therefore not
subject to review under Executive Orders 12866 and 13563 (76 FR 3821,
January 21, 2011). Because this action is not subject to notice and
comment requirements under the Administrative Procedures Act or any
other statute, it is not subject to the Regulatory Flexibility Act (5
U.S.C. 601 et seq.) or Sections 202 and 205 of the Unfunded Mandates
Reform Act of 1999 (UMRA) (Pub.L. 104-4). In addition, this action does
not significantly or uniquely affect small governments. This action
does not create new binding legal requirements that substantially and
directly affect Tribes under Executive Order 13175 (63 FR 67249,
November 9, 2000). This action does not have significant Federalism
implications under Executive Order 13132 (64 FR 43255, August 10,
1999). Because this final rule has been exempted from review under
Executive Order 12866, this final rule is not subject to Executive
Order 13211, entitled Actions Concerning Regulations That Significantly
Affect Energy Supply, Distribution, or Use (66 FR 28355, May 22, 2001)
or Executive Order 13045, entitled Protection of Children from
Environmental Health Risks and Safety Risks (62 FR 19885, April 23,
1997). This final rule does not contain any information collections
subject to OMB approval under the Paperwork Reduction Act (PRA), 44
U.S.C. 3501 et seq., nor does it require any special considerations
under Executive Order 12898, entitled Federal Actions to Address
Environmental Justice in Minority Populations and Low-Income
Populations (59 FR 7629, February 16, 1994). This action does not
involve technical standards; thus, the requirements of Section 12(d) of
the National Technology Transfer and Advancement Act of 1995 (15 U.S.C.
272 note) do not apply. The Congressional Review Act, 5 U.S.C. 801 et
seq., generally provides that before certain actions may take effect,
the agency promulgating the action must submit a report, which includes
a copy of the action, to each House of the Congress and to the
Comptroller General of the United States. Because this final action
does not contain legally binding requirements, it is not subject to the
Congressional Review Act.

    Dated: November 25, 2013.
David R. Lloyd,
Director, Office of Brownfields and Land Revitalization, Office of
Solid Waste and Emergency Response.
[FR Doc. 2013-28983 Filed 12-5-13; 8:45 am]
BILLING CODE 6560-50-P