[Federal Register Volume 85, Number 175 (Wednesday, September 9, 2020)]
[Proposed Rules]
[Pages 55627-55628]
[FR Doc No: 2020-19856]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2020-0701; Airspace Docket No. 20-ASO-19]
RIN 2120-AA66

Proposed Establishment of Class D and Class E Airspace and
Proposed Amendment of Class E Airspace; Nashville, TN

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of proposed rulemaking (NPRM).

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SUMMARY: This action proposes to establish Class D and Class E airspace
designated as an extension to Class D or E surface area, and amend
Class E airspace extending upward from 700 feet above the surface for
John C. Tune Airport, Nashville, TN, as a new air traffic control tower
shall service the airport. This action would also update the geographic
coordinates of the airport, as well as Sumner County Regional Airport,
and Lebanon Municipal Airport, and Murfreesboro Municipal Airport. In
addition, this action would establish Class E airspace extending upward
from 700 feet above the surface for Vanderbilt University Hospital
Heliport, as instrument approaches have been designed for the heliport.
Controlled airspace is necessary for the safety and management of
instrument flight rules (IFR) operations in the area.

DATES: Comments must be received on or before October 26, 2020.

ADDRESSES: Send comments on this proposal to: The U.S. Department of
Transportation, Docket Operations, 1200 New Jersey Avenue SE, West
Building Ground Floor, Room W12-140, Washington, DC 20590-0001;
Telephone:<PHONE_NUMBER>, or<PHONE_NUMBER>. You must identify the
Docket No. FAA-2020-0701; Airspace Docket No. 20-ASO-19, at the
beginning of your comments. You may also submit comments through the
internet at https://www.regulations.gov.
    FAA Order 7400.11D, Airspace Designations and Reporting Points, and
subsequent amendments can be viewed on line at https://www.faa.gov/air_traffic/publications/. For further information, you can contact the
Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC, 20591; Telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11D at NARA, email<EMAIL_ADDRESS>or go to https://www.archives.gov/federal-register/cfr/ibr-locations.html.

FOR FURTHER INFORMATION CONTACT: John Fornito, Operations Support
Group, Eastern Service Center, Federal Aviation Administration, 1701
Columbia Avenue, College Park, GA 30337; Telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it would establish Class D and Class E airspace, and amend Class E
airspace for John C. Tune Airport, and establish Class E airspace for
Vanderbilt University Hospital Heliport, Nashville, TN, to support IFR
operations in the area.

Comments Invited

    Interested persons are invited to comment on this proposed
rulemaking by submitting such written data, views, or arguments, as
they may desire. Comments that provide the factual basis supporting the
views and suggestions presented are particularly helpful in developing
reasoned regulatory decisions on the proposal. Comments are
specifically invited on the overall regulatory, aeronautical, economic,
environmental, and energy-related aspects of the proposal.
    Communications should identify both docket numbers (Docket No. FAA-
2020-0701 and Airspace Docket No. 20-ASO-19) and be submitted in
triplicate to DOT Docket Operations (see ADDRESSES section for the
address and phone number). You may also submit comments through the
internet at https://www.regulations.gov.
    Persons wishing the FAA to acknowledge receipt of their comments on
this action must submit with those comments a self-addressed stamped
postcard on which the following statement is made: ``Comments to FAA
Docket No. FAA-2020-0701; Airspace Docket No. 20-ASO-19''. The postcard
will be date/time stamped and returned to the commenter.
    All communications received before the specified closing date for
comments will be considered before taking action on the proposed rule.
The proposal contained in this document may be changed in light of the
comments received. All comments submitted will be available for
examination in the public docket both before and after the comment
closing date. A report summarizing each substantive public contact with
FAA personnel concerned with this rulemaking will be filed in the
docket.

Availability of NPRMs

    An electronic copy of this document may be downloaded through the
internet at http://www.regulations.gov. Recently published rulemaking
documents can also be accessed through the FAA's web page at https://www.faa.gov/air_traffic/publications/airspace_amendments/.
    You may review the public docket containing the proposal, any
comments received and any final disposition in person in the Dockets
Office (see the ADDRESSES section for address and phone number) between
9:00 a.m. and 5:00 p.m., Monday through Friday, except federal
holidays. An informal docket may also be examined between 8:00 a.m. and
4:30 p.m., Monday through Friday, except federal holidays

at the office of the Eastern Service Center, Federal Aviation
Administration, Room 350, 1701 Columbia Avenue, College Park, GA 30337.

Availability and Summary of Documents for Incorporation by Reference

    This document proposes to amend FAA Order 7400.11D, Airspace
Designations and Reporting Points, dated August 8, 2019, and effective
September 15, 2019. FAA Order 7400.11D is publicly available as listed
in the ADDRESSES section of this document. FAA Order 7400.11D lists
Class A, B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Proposal

    The FAA proposes an amendment to Title 14 Code of Federal
Regulations (14 CFR) part 71 to establish Class D and Class E airspace
designated as an extension to Class D airspace for John C. Tune
Airport, Nashville, TN, as a new air traffic control tower shall
service the airport. Also, the FAA proposes to increase the existing
Class E airspace extending upward from 700 feet above the surface, from
8-miles to 8.6-miles, due to a reevaluation of the airspace. In
addition, the FAA proposes to update the geographic coordinates of the
airport, as well as Sumner County Regional Airport, and Lebanon
Municipal Airport, and Murfreesboro Municipal Airport, to coincide with
the FAA's aeronautical database. Also, the FAA proposes to establish
Class E airspace extending upward from 700 feet above the surface for
Vanderbilt University Hospital Heliport, as instrument approaches have
been designed for the heliport.
    Class D and Class E airspace designations are published in
Paragraphs 5000, 6004, and 6005, respectively, of FAA Order 7400.11D,
dated August 8, 2019, and effective September 15, 2019, which is
incorporated by reference in 14 CFR 71.1. The Class E airspace
designations listed in this document will be published subsequently in
the Order.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

Regulatory Notices and Analyses

    The FAA has determined that this proposed regulation only involves
an established body of technical regulations for which frequent and
routine amendments are necessary to keep them operationally current.
It, therefore: (1) Is not a ``significant regulatory action'' under
Executive Order 12866; (2) is not a ``significant rule'' under DOT
Regulatory Policies and Procedures (44 FR 11034; February 26, 1979);
and (3) does not warrant preparation of a Regulatory Evaluation as the
anticipated impact is so minimal. Since this is a routine matter that
will only affect air traffic procedures and air navigation, it is
certified that this proposed rule, when promulgated, will not have a
significant economic impact on a substantial number of small entities
under the criteria of the Regulatory Flexibility Act.

Environmental Review

    This proposal will be subject to an environmental analysis in
accordance with FAA Order 1050.1F, ``Environmental Impacts: Policies
and Procedures'' prior to any FAA final regulatory action.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

The Proposed Amendment

    In consideration of the foregoing, the Federal Aviation
Administration proposes to amend 14 CFR part 71 as follows:

PART 71--DESIGNATION OF CLASS A, B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND REPORTING POINTS

0
1. The authority citation for part 71 continues to read as follows:

    Authority:  49 U.S.C. 106(f), 106(g); 40103, 40113, 40120; E.O.
10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of Federal Aviation
Administration Order 7400.11D, Airspace Designations and Reporting
Points, dated August 8, 2019, and effective September 15, 2019, is
amended as follows:

Paragraph 5000 Class D Airspace.

* * * * *

ASO TN D Nashville, TN [New]

John C. Tune Airport, TN
    (Lat. 36[deg]10'59'W'' N, long. 86[deg]53'11'' W)

    That airspace extending upward from the surface to and including
2,300 feet MSL, within a 4.1-mile radius of John C. Tune Airport.
This Class D airspace area is effective during the specific dates
and times established in advance by a Notice to Airmen. The
effective date and time will thereafter be continuously published in
the Chart Supplement.

Paragraph 6004 Class E Airspace Designated as an Extension to Class
D or E Surface Area.

* * * * *

ASO TN E4 Nashville, TN [New]

John C. Tune Airport, TN
    (Lat. 36[deg]10'59'W'' N, long. 86[deg]53'11'' W)

    That airspace extending upward from the surface within 1.2-miles
each side of the 198[deg] bearing from the airport, extending from
the 4.1-mile radius to 6.1-miles south of the airport, and within
1.2-miles each side of the 018[deg] bearing from the airport,
extending from the 4.1-mile radius to 6.1-miles north of the
airport.

Paragraph 6005 Class E Airspace Areas Extending Upward From 700
Feet or More Above the Surface of the Earth.

* * * * *

ASO TN E5 Nashville, TN [Amended]

Nashville International Airport, TN
    (Lat. 36[deg]07'28'' N, long. 86[deg]40'41'' W)
Smyrna Airport
    (Lat. 36[deg]00'32'' N, long. 86[deg]31'12'' W)
Sumner County Regional Airport
    (Lat. 36[deg]22'30'' N, long. 86[deg]24'30'' W)
Lebanon Municipal Airport
    (Lat. 36[deg]11'25'' N, long. 86[deg]18'56'' W)
Murfreesboro Municipal Airport
    (Lat. 35[deg]52'43'' N, long. 86[deg]22'39'' W)
John C. Tune Airport
    (Lat. 36[deg]10'59'' N, long. 86[deg]53'11'' W)
Vanderbilt University Medical Center Hospital, Point In Space
Coordinates
    (Lat. 36[deg]08'30'' N, long. 86[deg]48'6'' W)
    That airspace extending upward from 700 feet above the surface
within a 15 mile radius of Nashville International Airport, and
within a 9-mile radius of Smyrna Airport, and within a 7-mile radius
of Sumner County Regional Airport, and within a 10-mile radius of
Lebanon Municipal Airport, and within a 9-mile radius of
Murfreesboro Municipal Airport, and within an 8.6-mile radius of
John C. Tune Airport, and that airspace within a 6-mile radius of
the Point In Space serving Vanderbilt University Medical Center
Hospital.

    Issued in College Park, Georgia, on September 2, 2020.
Matthew N. Cathcart,
Manager, Airspace & Procedures Team North, Eastern Service Center, Air
Traffic Organization.
[FR Doc. 2020-19856 Filed 9-8-20; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 87, Number 163 (Wednesday, August 24, 2022)]
[Notices]
[Pages 52112-52113]
[FR Doc No: 2022-18173]

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DEPARTMENT OF TRANSPORTATION

Office of the Secretary

[Docket No. DOT-OST-2018-0204]

Air Carrier Access Act Advisory Committee; Solicitation for
Nominations

AGENCY:  Office of the Secretary (OST), Department of Transportation
(Department).

ACTION:  Solicitation of memberships for appointment to the Air Carrier
Access Act (ACAA) Advisory Committee (ACAA Advisory Committee or the
Committee).

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SUMMARY: The Department is soliciting applications and nominations for
memberships to the ACAA Advisory Committee. The ACAA Advisory Committee
reviews issues related to the air travel needs of passengers with
disabilities.

DATES: Nominations and applications for ACAA Advisory Committee
membership must be received on or before September 14, 2022.

FOR FURTHER INFORMATION CONTACT: If you have questions about the ACAA
Advisory Committee, you may contact Vinh Nguyen, Office of Aviation
Consumer Protection, U.S. Department of Transportation, by email at
[email protected], or by telephone at<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Section 439 of the FAA Reauthorization Act of 2018 (2018 FAA Act)
requires the Secretary of Transportation to establish an advisory
committee to identify and assess barriers to accessible air travel,
determine the extent to which DOT is addressing those barriers,
recommend improvements, and advise the Secretary on implementing the
ACAA. The 2018 FAA Act specifies that the ACAA Committee shall comprise
at least one representative of each of the following groups: passengers
with disabilities; national disability organizations; air carriers;
airport operators; contractor service providers; aircraft
manufacturers; wheelchair manufacturers; and national veteran
organizations representing disabled veterans.
    In September 2019, the Department established the ACAA Advisory
Committee, approved its charter, and appointed 19 members to serve on
the ACAA Advisory Committee for 2-year terms. The Committee held public
meetings in March 2020 and September 2021 and submitted a report with a
number of recommendations to the Department in February 2022. The terms
of the 19 Committee members have now expired. More information on the
ACAA Advisory Committee is available online at www.transportation.gov/airconsumer/ACAACommittee.

II. Eligibility for Membership and Selection Criteria

    Because the terms of the previously appointed members have expired,
the Department is soliciting new applications and nominations for
individuals to serve on the ACAA Advisory Committee. Unless it is
renewed, the Committee's charter expires on September 28, 2023, and
individuals would be appointed to serve for a term not to exceed the
life of the charter. Pursuant to the 2018 FAA Act and the ACAA Advisory
Committee's Charter,\1\ the membership of the Committee shall comprise
at least one

representative each of the following groups:
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    \1\ The ACAA Advisory Committee's Charter is available online at
www.transportation.gov/individuals/aviation-consumer-protection/charter-air-carrier-access-act-advisory-committee.
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    1. Passengers with disabilities;
    2. National disability organizations;
    3. Air carriers;
    4. Airport operators;
    5. Contractor service providers;
    6. Aircraft manufacturers;
    7. Wheelchair manufacturers; and
    8. National veterans' organizations representing disabled veterans.
    The chairperson will be designated from among the members
appointed. The Department may select more than one representative for a
group, if appropriate, to obtain a fairly balanced membership.
    The Department will choose members based on four main criteria:
    1. Representativeness (does the applicant represent a significant
stakeholder group described above);
    2. Expertise (does the applicant bring essential knowledge,
expertise, and/or experience regarding accessibility);
    3. Balance (do selected applicants comprise a balanced array of
representative and expert stakeholders); and
    4. Willingness to participate fully (is the applicant able and
willing to attend the listed meetings and generally contribute
constructively to a rigorous policy development process).
    Individuals applying for membership should keep in mind that ACAA
Advisory Committee members will be selected based on their ability and
willingness to effectively represent the interests of all stakeholders
in their category, as distinct from their parochial or personal
interests. For example, an individual selected to serve on the
Committee as a representative of ultra low cost carrier (ULCC) would
represent not only his or her own airline, but all ULCCs. As such, the
individual would be expected to consult with other airlines in bringing
issues to the table and making decisions on proposals before the
Committee.
    Nominations are open to all individuals without regard to race,
color, religion, sex, national origin, age, disability, marital status,
or sexual orientation. Past members of the Committee will also be
eligible to be nominated for or to seek reappointment on the Committee.

III. Process for Submitting Nominations

    Individuals can self-apply or be nominated by any individual or
organization. To be considered for the ACAA Advisory Committee,
applicants/nominators must submit the following information:
    1. Name, title, organization, and contact information (address,
telephone number and email address) of nominee/applicant;
    2. Category of membership that the nominee/applicant is qualified
to represent;
    3. Resume of the applicant or short biography of the nominee
including professional and academic credentials;
    4. A statement of nomination on why the applicant wants to serve or
the nominator is nominating the individual to serve, and the unique
perspectives and expenses the nominee brings to the Committee;
    5. An affirmative statement that the applicant/nominee meets the
eligibility requirements; and
    6. Optional letters of support.
    Please do not send company, trade association, organization
brochures, or any other promotional information. Materials submitted
should total five pages or less. Should more information be needed,
Department staff will contact the applicant/nominee, obtain information
from the applicant's/nominee's past affiliations, or obtain information
from publicly available sources.
    All application/nomination materials must be submitted
electronically via email to [email protected].
Applications and nominations must be received by September 14, 2022.

IV. Compensation for Members

    Pursuant to section 439(e) of the 2018 FAA Act, Committee members
will be reimbursed for travel and per diem expenses as permitted under
applicable Federal travel regulations. Reimbursement is subject to
funding availability. Committee members will receive no salary or other
compensation for participation in Committee activities.
    The Secretary reserves the discretion to appoint members to serve
on the ACAA Advisory Committee who were not nominated in response to
this notice if necessary to meet specific statutory categories and
departmental needs in a manner to ensure an appropriate balance of
membership. Individuals selected for appointment to the ACAA Advisory
Committee will be notified by return email and by a letter of
appointment.

    Issued in Washington, DC, on or about this 15th day of August
2022.
John E. Putnam,
General Counsel.
[FR Doc. 2022-18173 Filed 8-23-22; 8:45 am]
BILLING CODE P


[Federal Register Volume 76, Number 149 (Wednesday, August 3, 2011)]
[Notices]
[Page 46798]
[FR Doc No: 2011-19682]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-UST-2010-0651; FRL-9447-3]

Compatibility of Underground Storage Tank Systems With Biofuel
Blends; Correction

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; correction.

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SUMMARY: This document contains a typographical correction to the
guidance which was published in the Federal Register of Tuesday, July
5, 2011. The guidance described how owners and operators of underground
storage tanks (USTs) can demonstrate compliance with the Federal
compatibility requirement for UST systems storing gasoline greater than
10 percent ethanol or diesel containing greater than 20 percent
biodiesel. That guidance contained a typographical error which this
action corrects. The complete, corrected version of the guidance can be
found on EPA's Web site.

FOR FURTHER INFORMATION CONTACT: Andrea Barbery,<PHONE_NUMBER>.

Correction

    In the Federal Register of July 5, 2011, in 76 FR 39095, on page
39100, in the second column, correct the fourth paragraph under ``IV.
Final Guidance'' to read:

    The discussion in this document is intended solely as guidance.
The statutory provisions and EPA regulations described in this
document contain legally binding requirements. This document is not
a regulation itself, nor does it change or substitute for those
provisions and regulations. Thus, it does not impose legally binding
requirements on EPA, states, or the regulated community.

    Dated: July 28, 2011.
Mathy Stanislaus,
Assistant Administrator, Office of Solid Waste and Emergency Response.
[FR Doc. 2011-19682 Filed 8-2-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 86, Number 120 (Friday, June 25, 2021)]
[Rules and Regulations]
[Pages 33541-33542]
[FR Doc No: 2021-13450]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R07-OAR-2021-0244; FRL-10025-00-Region 7]

Air Plan Approval; Nebraska; Revisions to Title 129 of the
Nebraska Administrative Code; Chapter 39 Visible Emissions From Diesel-
Powered Motor Vehicles

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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SUMMARY: The Environmental Protection Agency (EPA) is taking final
action to approve a revision to the State Implementation Plan (SIP) for
the State of Nebraska. This final action will amend the SIP to revise
title 129 of the Nebraska Administrative Code by removing a portion of
the SIP that addresses visible emissions from diesel-powered motor
vehicles. Visible emissions from diesel-powered motor vehicles are
addressed in the state statute. The revisions remove duplicative
language that is redundant to the state statute. The revisions do not
substantively change any existing statutory or regulatory requirement
or impact the stringency of the SIP or air quality nor do they impact
the State's ability to attain or maintain the National Ambient Air
Quality Standards.

DATES: This final rule is effective on July 26, 2021.

ADDRESSES: The EPA has established a docket for this action under
Docket ID No. EPA-R07-OAR-2021-0244. All documents in the docket are
listed on the https://www.regulations.gov website. Although listed in
the index, some information is not publicly available, i.e., CBI or
other information whose disclosure is restricted by statute. Certain
other material, such as copyrighted material, is not placed on the
internet and will be publicly available only in hard copy form.
Publicly available docket materials are available through https://www.regulations.gov or please contact the person identified in the FOR
FURTHER INFORMATION CONTACT section for additional information.

FOR FURTHER INFORMATION CONTACT: Allie Donohue, Environmental
Protection Agency, Region 7 Office, Air Quality Planning Branch, 11201
Renner Boulevard, Lenexa, Kansas 66219; telephone number: (913) 551-
7986; email address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Throughout this document ``we,'' ``us,'' and
``our'' refer to EPA.

Table of Contents

I. What is being addressed in this document?
II. Have the requirements for approval of a SIP revision been met?
III. What action is the EPA taking?
IV. Incorporation by Reference
V. Statutory and Executive Order Reviews

I. What is being addressed in this document?

    The EPA is amending Nebraska's SIP to include revisions to title
129 of the Nebraska Administrative Code. The EPA is approving revisions
to the Nebraska SIP received on July 16, 2020. Specifically, the EPA is
amending the Nebraska SIP by removing a portion of the SIP as follows:
Title 129. Chapter 39. Visible Emissions from Diesel-powered Motor
Vehicles. EPA is approving these revisions as they do not substantively
change any existing statutory or regulatory requirement. These
revisions do not impact the stringency of the SIP or air quality. The
EPA solicited comments on the proposed revision to Nebraska's SIP, and
received no comments.

II. Have the requirements for approval of a SIP revision been met?

    The state submission has met the public notice requirements for SIP
submissions in accordance with 40 CFR 51.102. The submission also
satisfied the completeness criteria of 40 CFR part 51, appendix V. The
State provided public notice of the SIP revision from September 28,
2019, to November 6, 2019, and held a public hearing on November 7,
2019. In a letter to the state dated November 7, 2019, the EPA stated
that the agency ``has no comment on the proposed repeal of this
regulation.'' EPA further recommended that NDEE include a justification
that the rule is redundant to state statute. The SIP revision meets the
substantive requirements of the CAA, including section 110 and
implementing regulations.

III. What action is the EPA taking?

    The EPA is taking final action to amend the Nebraska SIP by
approving the State's request to remove Title 129 section 39. Visible
Emissions from Diesel-powered Vehicles. The removal of this portion of
the SIP will ensure consistency between state and federally-approved
rules. The EPA has determined that these changes will not adversely
impact air quality because the regulation duplicates the State's
statute, which applies in the same jurisdiction.

IV. Incorporation by Reference

    In this document, the EPA is amending regulatory text that includes
incorporation by reference. As described in the amendments to 40 CFR
part 52 set forth below, the EPA is removing provisions of the EPA-
Approved Nebraska Regulations from the Nebraska State Implementation
Plan, which is incorporated by reference in accordance with the
requirements of 1 CFR part 51.

V. Statutory and Executive Order Reviews

    Under the CAA, the Administrator is required to approve a SIP
submission that complies with the provisions of the CAA and applicable
Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in
reviewing SIP submissions, the EPA's role is to approve state choices,
provided that they meet the criteria of the CAA. Accordingly, this
action merely approves state law as meeting Federal requirements and
does not impose additional requirements beyond

those imposed by state law. For that reason, this action:
     Is not a significant regulatory action subject to review
by the Office of Management and Budget under Executive Orders 12866 (58
FR 51735, October 4, 1993) and 13563 (76 FR 3821, January 21, 2011);
     Does not impose an information collection burden under the
provisions of the Paperwork Reduction Act (44 U.S.C. 3501 et seq.);
     Is certified as not having a significant economic impact
on a substantial number of small entities under the Regulatory
Flexibility Act (5 U.S.C. 601 et seq.);
     Does not contain any unfunded mandate or significantly or
uniquely affect small governments, as described in the Unfunded
Mandates Reform Act of 1995 (Pub. L. 104-4);
     Does not have federalism implications as specified in
Executive Order 13132 (64 FR 43255, August 10, 1999);
     Is not an economically significant regulatory action based
on health or safety risks subject to Executive Order 13045 (62 FR
19885, April 23, 1997);
     Is not a significant regulatory action subject to
Executive Order 13211 (66 FR 28355, May 22, 2001);
     Is not subject to requirements of the National Technology
Transfer and Advancement Act (NTTA) because this rulemaking does not
involve technical standards; and
     Does not provide EPA with the discretionary authority to
address, as appropriate, disproportionate human health or environmental
effects, using practicable and legally permissible methods, under
Executive Order 12898 (59 FR 7629, February 16, 1994).
    In addition, the SIP is not approved to apply on any Indian
reservation land or in any other area where the EPA or an Indian tribe
has demonstrated that a tribe has jurisdiction. In those areas of
Indian country, the rule does not have tribal implications and will not
impose substantial direct costs on tribal governments or preempt tribal
law as specified by Executive Order 13175 (65 FR 67249, November 9,
2000).
    The Congressional Review Act, 5 U.S.C. 801 et seq., as added by the
Small Business Regulatory Enforcement Fairness Act of 1996, generally
provides that before a rule may take effect, the agency promulgating
the rule must submit a rule report, which includes a copy of the rule,
to each House of the Congress and to the Comptroller General of the
United States. EPA will submit a report containing this action and
other required information to the U.S. Senate, the U.S. House of
Representatives, and the Comptroller General of the United States prior
to publication of the rule in the Federal Register. A major rule cannot
take effect until 60 days after it is published in the Federal
Register. This action is not a ``major rule'' as defined by 5 U.S.C.
804(2).
    Under section 307(b)(1) of the CAA, petitions for judicial review
of this action must be filed in the United States Court of Appeals for
the appropriate circuit by August 24, 2021. Filing a petition for
reconsideration by the Administrator of this final rule does not affect
the finality of this action for the purposes of judicial review nor
does it extend the time within which a petition for judicial review may
be filed, and shall not postpone the effectiveness of such rule or
action. This action may not be challenged later in proceedings to
enforce its requirements (see section 307(b)(2)).

List of Subjects in 40 CFR Part 52

    Environmental protection, Air pollution control, Incorporation by
reference, Intergovernmental relations, Particulate matter.

    Dated: June 14, 2021.
Edward H. Chu,
Acting Regional Administrator, Region 7.

    For the reasons stated in the preamble, the EPA amends 40 CFR part
52 as set forth below:

PART 52--APPROVAL AND PROMULGATION OF IMPLEMENTATION PLANS

0
1. The authority citation for part 52 continues to read as follows:

    Authority:  42 U.S.C. 7401 et seq.

Subpart CC--Nebraska

Sec.  52.1420  [Amended]

0
2. In Sec.  52.1420, the table in paragraph (c) is amended by removing
the entry ``129-39'' under ``Title 129-Nebraska Air Quality
Regulations''.

[FR Doc. 2021-13450 Filed 6-24-21; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 80, Number 181 (Friday, September 18, 2015)]
[Notices]
[Page 56525]
[FR Doc No: 2015-23401]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-75908; File No. SR-CBOE-2015-026]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Designation of a Longer Period for Commission
Action on Proceedings To Determine Whether To Approve or Disapprove a
Proposed Rule Change Relating to Rules 6.74A and 6.74B

September 14, 2015.
    On March 6, 2015, Chicago Board Options Exchange, Incorporated (the
``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (the ``Commission''), pursuant to Section 19(b)(1) of the
Securities Exchange Act of 1934 (the ``Act''),\1\ and Rule 19b-4
thereunder,\2\ a proposed rule change to amend its rules regarding the
solicitation of Market-Makers as the contra party to an agency order
entered into the Exchange's Automated Improvement Mechanism (``AIM'')
and Solicitation Auction Mechanism (``SAM'') auctions. The proposed
rule change was published for comment in the Federal Register on March
23, 2015.\3\ On May 4, 2015, the Commission extended the time period
within which to approve the proposed rule change, disapprove the
proposed rule change, or institute proceedings to determine whether to
disapprove the proposed rule change, to June 21, 2015.\4\ On June 18,
2015, the Commission instituted proceedings to determine whether to
approve or disapprove the proposed rule change.\5\ On July 21, 2015,
the Commission received a letter from the Exchange responding to the
Order Instituting Proceedings.\6\ Subsequently, the Commission received
one other comment letter on the proposed rule change.\7\
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 74519 (March 17,
2015), 80 FR 15264 (``Notice'').
    \4\ See Securities Exchange Act Release No. 74862 (May 4, 2015),
80 FR 26599 (May 8, 2015).
    \5\ See Securities Exchange Act Release No. 75245 (June 18,
2015), 80 FR 36386 (June 24, 2015) (``Order Instituting
Proceedings'').
    \6\ See Letter to Brent J. Fields, Secretary, Commission, from
Kyle Edwards, Attorney, CBOE, dated July 21, 2015 (``CBOE Letter'').
    \7\ See Letter to Brent J. Fields, Secretary, Commission, from
Gavin Rowe, Senior Director, Dash Financial LLC, dated August 11,
2015 (``Dash Financial Letter'').
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    Section 19(b)(2) of the Act \8\ provides that, after initiating
disapproval proceedings, the Commission shall issue an order approving
or disapproving the proposed rule change not later than 180 days after
the date of publication of notice of filing of the proposed rule
change. The Commission may extend the period for issuing an order
approving or disapproving the proposed rule change, however, by not
more than 60 days if the Commission determines that a longer period is
appropriate and publishes the reasons for such determination. In this
case, the proposed rule change was published for notice and comment in
the Federal Register on March 23, 2015.\9\ September 19, 2015, is 180
days from that date, and November 18, 2015, is 240 days from that date.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(2).
    \9\ See supra note 3.
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    The Commission finds it appropriate to designate a longer period
within which to issue an order approving or disapproving the proposed
rule change so that it has sufficient time to consider the proposed
rule change and the comment letters submitted in response to the Order
Instituting Proceedings.
    Accordingly, the Commission, pursuant to Section 19(b)(2) of the
Act,\10\ designates November 18, 2015 as the date by which the
Commission shall either approve or disapprove the proposed rule change
(File No. SR-CBOE-2015-026).
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    \10\ 15 U.S.C. 78s(b)(2).

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\11\
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    \11\ 17 CFR 200.30-3(a)(57).
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Brent J. Fields,
Secretary.
[FR Doc. 2015-23401 Filed 9-17-15; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register: December 9, 2005 (Volume 70, Number 236)]
[Notices]
[Page 73216]
[DOCID:fr09de05-47]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EC06-32-000]

Boston Generating, LLC; Mystic I, LLC; Mystic Development, LLC;
Fore River Development, LLC; EBG Holdings, LLC; Notice of Filing

December 2, 2005.
    Take notice that on November 28, 2005, Boston Generating, LLC and
its three wholly-owned subsidiaries, Mystic I, LLC, Mystic Development,
LLC and Fore River Development, LLC, and EBG Holdings, LLC
(collectively, Applicants) filed with the Commission an application
requesting that the Commission grant all authorizations and approvals
necessary under section 203 of the Federal Power Act for an indirect
disposition of jurisdictional facilities as a result of certain
proposed transfers of equity interests in EBG Holdings.
    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date.
Anyone filing a motion to intervene or protest must serve a copy of
that document on the Applicant and all the parties in this proceeding.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov.
 Persons unable to file electronically should submit an

original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street, NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For TTY,

call<PHONE_NUMBER>.
    Comment Date: 5 p.m. eastern time on December 19, 2005.

Magalie R. Salas,
Secretary.
 [FR Doc. E5-7150 Filed 12-8-05; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register: April 5, 2006 (Volume 71, Number 65)]
[Notices]
[Page 17089]
[DOCID:fr05ap06-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2146-113]

Alabama Power Company; Notice of Availability of Environmental
Assessment

March 29, 2006.
    In accordance with the National Environmental Policy Act of 1969
and the Federal Energy Regulatory Commission's regulations, the Office
of Energy Projects has reviewed the application requesting the
Commission's authorization for non-project use of project lands and
waters for a water withdrawal at the Logan Martin development of the
Coosa River Project. The proposed withdrawal would be located south of
Ragland, Alabama. An environmental assessment (EA) has been prepared.
    In the EA, the Commission's staff concludes that approval of the
licensee's application would not produce any significant adverse
environmental impacts, consequently the proposal would not constitute a
major federal action significantly affecting the quality of the human
environment.
    A copy of the EA is attached to the Commission order titled
``Approving Non-Project use of Project Lands and Waters, issued March
28, 2006, and is available at the Commission's Public Reference Room. A
copy of the EA may also be viewed on the Commission's Web site at
http://www.ferc.gov using the ``elibrary'' link. Enter the docket

numbers (P-2146) in the docket field to access the document. For
assistance, call<PHONE_NUMBER> or<PHONE_NUMBER> (for TTY).

Magalie R. Salas,
Secretary.
 [FR Doc. E6-4881 Filed 4-4-06; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 216 (Thursday, November 9, 2017)]
[Notices]
[Pages 52060-52061]
[FR Doc No: 2017-24408]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2017-N-6358]

Blood Products Advisory Committee Advisory Committee; Notice of
Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Blood Products Advisory
Committee (the Committee). The general function of the committee is to
provide advice and recommendations to the Agency on FDA's regulatory
issues related to blood and products derived from blood. The meeting
will be open to the public.

DATES: The meeting will be held on November 30, 2017, from 8 a.m. to
5:45 p.m. and on December 1, 2017, from 8 a.m. to 3:30 p.m.

ADDRESSES: FDA White Oak Campus, 10903 New Hampshire Ave., Building 31
Conference Center, the Great Room (Rm. 1503), Silver Spring, MD, 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Bryan Emery or Joanne Lipkind, Center
for Biologics Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Avenue, Silver Spring, MD 20993-0002, Bldg. 71, Rm.
6132, at<PHONE_NUMBER>, [email protected] and<PHONE_NUMBER>,
[email protected] respectively, or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at https://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting. For those unable to attend in person, the meeting will
also be available via Webcast. The Webcast will be available at the
following link for both days: https://collaboration.fda.gov/bpac2017.

SUPPLEMENTARY INFORMATION:
    Agenda: On November 30, 2017, the Committee members will meet in
open session to discuss bacterial risk control strategies for blood
collection establishments and transfusion services to enhance the
safety and availability of platelets for transfusion. In the afternoon,
the Committee will be seated as a device classification panel. In open
session, the panel will discuss the appropriate device classification
of human leukocyte antigen, human platelet antigen, and human
neutrophil antigen devices. On December 1, 2017, the committee members
will meet in open session to discuss strategies to reduce the risk of
transfusion-transmitted Zika virus. In the afternoon, an information
session on the Transfusion Transmissible Infections Monitoring System
will be presented to the Committee. Finally, the Committee will hear an
update presentation on the April 6, 2017, FDA public workshop on
emerging tick-borne diseases and blood safety.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at https://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
November 22, 2017. Oral presentations from the public will be scheduled
between approximately 11:35 a.m. to 12:20 p.m. and 4:15 p.m. to 4:45
p.m. on November 30, 2017. Oral presentations from the public will also
be scheduled between approximately 10:45 a.m. and 11:30 a.m. and 3 p.m.
to 3:30 p.m. on December 1, 2017. Those individuals interested in
making formal oral presentations should notify the contact person and
submit a brief statement of the general nature of the evidence or
arguments they wish to present, the names and addresses of proposed
participants, and an indication of the approximate time requested to
make their presentation on or before November 14, 2017. Time allotted
for each presentation may be limited. If the number of registrants
requesting to speak is greater than can be reasonably accommodated
during the scheduled open public hearing session, FDA may conduct a
lottery to determine the speakers for the scheduled open public hearing
session. The contact person will notify interested persons regarding
their request to speak by November 15, 2017.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Bryan Emery or Joanne Lipkind at least 7 days in advance of the
meeting.

    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: November 6, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-24408 Filed 11-8-17; 8:45 am]
 BILLING CODE 4164-01-P


NEWS BRIEF

September 7, 2006

EPA Methyl Bromide Inventory Data Shows Downward Trend

Contact:  John Millett,<PHONE_NUMBER> -<EMAIL_ADDRESS>
Today EPA released data showing a steady decline in the aggregate methyl
bromide inventory held by companies in the United States since 2003,
when the Agency began collecting such information.

Methyl bromide is a widely used soil fumigant that is also a powerful
ozone-depleting substance.  Under the Montreal Protocol on Substances
that Deplete the Ozone Layer and the Clean Air Act, the United States
phased out new production and import of methyl bromide, except for
allowable exemptions for users who have no technically and economically
feasible alternatives.  Methyl bromide needs for these critical uses are
met through allowable production under the Montreal Protocol’s
exemption process as well as the use of existing inventory held by
companies in the United States.

EPA’s release of the aggregate inventory numbers was made possible by
the conclusion of two lawsuits that had been brought to prevent the
release of the aggregate data.  The data includes, in aggregate form,
the inventory held by approximately 35 companies in the United States
from 2003 to 2005.  The methyl bromide inventory data, displayed
graphically below, shows a continued decrease – approximately 16,422
metric tons in 2003, 12,994 metric tons in 2004, and 9,974 metric tons
in 2005 - and demonstrates that the United States is managing its
domestic inventory appropriately.

Since 1994, the U.S. Government has invested over $150 million in
research and innovative technologies to promote alternatives to methyl
bromide.  In addition, U.S. farmers have adopted innovative technologies
to reduce methyl bromide use and emissions, such as reduced methyl
bromide concentrations in mixtures, and the use of tarps to retain
methyl bromide in the soil for longer periods of time.

While not as highly damaging to the ozone layer as other chemicals that
have already been phased out (like chlorofluorocarbons, or CFCs),
scientists have reaffirmed its status as a powerful ozone-depleting
chemical.  The World Meteorological Organization and the United Nations
Environment Programme 2006 Scientific Assessment recently affirmed that
bromine continues to play a major role in stratospheric ozone depletion.
 The ongoing transition to methyl bromide alternatives continues to be
an important priority for EPA.

The phaseout of new production and import and the orderly reduction in
the existing inventory that facilitates transition to alternatives are
proceeding in a manner consistent with previous successful phaseouts of
ozone-depleting substances, such as chlorofluorocarbons (CFCs) and
halons.  The U.S. continues to protect the ozone layer and meet its
obligations under the Montreal Protocol while meeting the needs of
American farmers.

For more information on the phaseout of methyl bromide, please visit:
HYPERLINK "http://www.epa.gov/ozone/mbr"  http://www.epa.gov/ozone/mbr

 PAGE

 PAGE   2


the frequency of CBP cargo and trade examination.  FDA likewise uses a risk-based approach in
selecting foods for examination at the border for security and food safety reasons.  FDA, thus, is
continuing to explore with CBP and industry use of these programs in making decisions
regarding which products to inspect for the purposes of admissibility (801(a) decisions).
Comments addressing which foreign operators are eligible for participation in FAST and
C-TPAT are outside the scope of this rule.  CBP stated in a document entitled “Frequently Asked
Questions Regarding Minimum Security Criteria for Importers,” dated March 25, 2005, (CBP’s
March 25, 2005, Frequently Asked Questions (FAQ) document) (available at
http://www.cbp.gov/xp/cgov/import/commercial_enforcement/ctpat/security_criteria/criteria_im
porters/questions.xml), that “C-TPAT remains a voluntary, incentive based partnership.
However, once a company commits to the C-TPAT program, there are specific program

71
requirements that must be adhered to by the company to qualify for C-TPAT benefits, which are
significant. C-TPAT importers are six times less likely to undergo a security related cargo
examination, and four times less likely to be subject to a trade related examination, than non-C-
TPAT members. These significantly fewer cargo examinations help save importers time and
money, while leading to a more predictable supply chain. CBP continues to explore additional
benefits, which can be afforded members who meet or exceed the minimum-security criteria.”
The document also states that “CBP employs a risk management approach in screening
and targeting, and such shipments, as well as those from unknown or less established entities,
receive higher scrutiny from CBP. The agency does not disclose ATS targeting rules.”
(Comments) Several comments suggest that FDA should not establish a duplicative
program, but should incorporate additional factors or criteria necessary for prior notice into
existing programs.
(Response) FDA agrees that it is generally preferable not to establish duplicative
programs.  Thus, while we have determined not to provide C-TPAT members with special
treatment in terms of reduced prior notice information requirements or reduced timeframes, we
will continue exploring use of these programs in making decisions regarding which products to
inspect for the purposes of admissibility (801(a) decisions).
b. Special programs.
i. Should food products subject to FDA's prior notice requirements be eligible for the full
expedited processing and information transmission benefits allowed with C-TPAT and FAST? If
so, how should this be accomplished? (Comments) Numerous comments assert that businesses
that participate in the C-TPAT and FAST programs should be eligible for
processing/transmission benefits.  These comments contend that importers, carriers and drivers

72
who have been approved for C-TPAT and FAST already have been deemed to be “low risk” by
CBP.  Importers and carriers have had to demonstrate supply chain security controls, and drivers
have been subjected to rigorous background screening.  Companies have made the security
investments and have bolstered their operations to provide the requisite security and integrity of
their trade transactions.  The federal governments of the United States and Canada have
encouraged FAST participation on the grounds that it will mean expedited border crossings and
reduced information requirements.  By allowing food to move through the FAST “stream” in the
same manner as other products, FDA would demonstrate the commitment to harmonization that
industry has long encouraged and would provide an incentive for additional participation in the
C-TPAT and FAST programs.  In addition, the comments noted that if the primary benefits of
the C-TPAT program were removed, FDA would create a disincentive for C-TPAT participation
that would ultimately reduce the security of the articles covered by the Bioterrorism Act.
Finally, the comments note that these benefits are necessary to avoid duplication and inconsistent
application of prior notice requirements for shipments that meet the stringent FAST criteria.
(Response) FDA continues to use a risk-based approach for determining which foods to
inspect for the purposes of admissibility.  FDA will continue to work with CBP and
acknowledges that the additional information provided by C-TPAT participation could be helpful
in this risk-based assessment.  In CBP’s March 25, 2005, FAQ document cited previously, CBP
states that “[u]nsolicited shipments will understandably lie outside the capability of the importer
to ensure security. CBP employs a risk management approach in screening and targeting, and
such shipments, as well as those from unknown or less established entities, receive higher
scrutiny from CBP.”  FDA agrees with this statement.

73
(Comments) Numerous comments provide suggestions on how to accomplish
processing/transmission benefits for C-TPAT and FAST participants.  Many of the comments
cite a need for better harmonization and streamlining between FDA and CBP.  Suggestions from
the comments include:
•
Enhance coordination between CBP and FDA, allowing trained CBP/FDA officers to
process food shipments through the FAST lane, and allowing FAST importers using a
FAST driver and carrier importing food and/or feed products to submit prior notice to
both the CBP and FDA through the existing CBP/FDA interface.
•
Allow for integrated targeting processes, including a reduction in the risk targeting
factors for food shipments, as well as other product categories, which would translate into
expedited processing, reduced exams and other benefits for food import shipments under
the program.
•
Integrate the CBP and FDA data systems to allow for one filing of the required
information.  The C-TPAT certification process delves into the critical aspects of a
company’s handling and documentation procedures, and requires a company to
demonstrate it has good process controls in place throughout the supply chain.
•
Modify the CBP and FDA systems for the receipt of advance notice and prior notice to
“flag” importation under C-TPAT and FAST.  These notices should receive priority
attention for entry and clearance purposes.
•
Establish an MOU between FDA and CBP to allow the sharing of necessary information
with the understanding of the program applicant.
•
Implement a shorter prior notice timeframe for C-TPAT members.

74
•
Reduce data element reporting by virtue of having successfully passed the C-TPAT
validation process.  Product information (HTS code, product code, manufacturer’s
registration numbers, etc.) should be part of the pre-filed information profiles under
FAST.
Finally, one comment suggests the following:
(1) A statement of proof of acceptance (e.g., copy of acceptance letter from CBP) into the
C-TPAT and/or FAST programs;
(2) A detailed statement/description of policies and procedures in place for meeting FDA
prior notice requirements.  This submission should follow the format of the supply chain
questionnaire information submitted to CBP as part of the C-TPAT application process and
should be considered as an addendum to the original submission; and
(3) FDA should notify the importer in writing of: (a) its acceptance/agreement with the
importer’s FDA prior notice procedures; or (b) additional questions to be answered or data to be
provided to meet FDA requirements for acceptance into the FDA prior notice “C-TPAT/FAST”
program.
(Response) As we discussed previously, we have determined not to provide C-TPAT
members with special treatment in terms of reduced prior notice information requirements or
reduced timeframes.  FDA, however, is continuing to explore with CBP and industry use of these
programs in making decisions regarding which products to inspect for the purposes of
admissibility (801(a) decisions).
ii. If the timeframe for submitting prior notice for food arriving by land via road is
reduced to 1 hour consistent with the timeframe in the advance electronic information rule,
would a shorter timeframe be needed for members of FAST? (Comments) One comment

75
suggests that the timeframe for submitting prior notice of one hour is fine, even for express
deliveries.  Another comment believes that reducing the timeframes for submission of prior
notice would not sufficiently expedite the clearance of product for participants of FAST.
However, an overwhelming majority of the comments favor reducing the timeframe for FAST
participants to 30 minutes.  Under the CBP Advance Electronic Information Rule, the time
element for FAST participants is 30 minutes.  The comments state that to have two different time
standards for the same mode of transportation only serves to create confusion.  The comments
believe that any harmonization of FDA and CBP security programs would assist the orderly flow
of trade at the border crossing points.
The comments contend that the key premise behind the FAST program is that low-risk
parties should receive expedited treatment at the border, freeing up enforcement resources to
concentrate on parties of higher or unknown risk, which is why the timeframes CBP adopted are
shorter for FAST than for other shipments.  If FDA adopted the 30 minute timeframe, it would
demonstrate a commitment to harmonizing with CBP, and prevent a situation whereby FAST
requirements vary depending on the type of commodity being transported.  Finally, one comment
believes that to ensure consistency with FAST and CBP’s Automated Commercial Environment
(ACE), prior notice should be required and calculated from the port of entry and not the first
4
point of arrival, as is currently the case.
(Response) Harmonized timeframes could facilitate the orderly flow of trade traffic at the
borders.  Advance screening of consistent information also would aid in reducing the review
time.  However, as we discuss later in section II.F of this document (“When must prior notice be
submitted to FDA? (9.279)”), we are maintaining  the timeframes that are in the IFR.  These
4
The ACE system will replace the current ABI/ACS, as well as combine other CBP entry functions and
transactions. Prior Notice submissions will be compatible with ACE.

76
timeframes represent the minimum amount of time FDA needs to meet the statutory
responsibility to receive, review, and respond to prior notice submissions.  Our assessment of the
timeframes and review times showed that we would not be able to reduce the timeframes to
correspond to those used by CBP for land and air shipments.
iii. Should the security and verification processes in C-TPAT be modified in any way to
handle food and animal feed shipments regulated by FDA? If so, how? (Comments) Four
comments respond that the security/verification processes of C-TPAT/FAST should be modified
for food.  Fourteen comments respond that the process should not be modified for food.  Most
comments suggest that the current validation processes are sufficient and caution that additional
FDA inspection would be redundant.  Many of these comments state that C-TPAT is a well-
thought-out program and that with its current security profile requirements and present followup
verification systems, the program is already well suited to handle human and animal food
shipments.  The comments suggest that FDA should rely on CBP’s successful programs and
avoid “recreating the wheel” or imposing new and potentially inconsistent criteria on food
companies.  The comments further contend that food safety and product integrity is already an
integral part of the industry’s own internal policies, which have always been concerned and
accountable for the safety and security of their products without regard to the more recent border
security program.  Therefore, companies certified under C-TPAT have made the critical security
investments and have bolstered their operations to provide the requisite security and integrity of
their trade transactions, regardless of the commodities (food or non-food products) that are
shipped.  Another comment stresses that FDA should not impose additional conditions of
participation for FAST members because the requirements for FAST participation imposed by
CBP provide adequate assurance that expedited clearance is appropriate.

77
(Response) FDA agrees with the statement in CBP’s March 25, 2005, FAQ document
that says “For C-TPAT to ensure its continued viability, effectiveness, and relevance, the
program must continue to evolve--as the terrorist threat and the nature of global trade evolves.
The impetus for strengthening the existing security guidelines is to provide more detail to the
membership on the expectations of the program, and to assist CBP in defining a more consistent
baseline for minimal program requirements and better-defined C-TPAT benefits.”  The issue of
how to modify the processes is discussed in the next comments and responses.
(Comments) Numerous comments provide suggestions on how to modify the
security/verification processes of C-TPAT/FAST.  These include:
•
FDA should investigate security plans with actual physical inspections of the facilities
prior to allowing participation in the programs.
•
FDA should verify that other countries’ regulatory systems for food production and
safety are equivalent to those of the United States.  The agency should also perform on-
site audits and inspection of production facilities before a food manufacturer or carrier
can be certified.
•
It should be mandatory for food manufacturers to provide notice concerning any changes
in the manufacturing processes or supplies, as well as those that may affect physical and
personnel security.  In addition, the current requirements that manufacturers periodically
review the security commitment of their service providers to detect weakness or potential
weaknesses in security should be altered to require that: (1) The review is conducted on
an annual basis and (2) a certification that the review has been conducted.
•
FDA and CBP should work together, along with the trade community, to identify
potential areas where the C-TPAT security and verification processes can or should be

78
modified.  CBP and FDA should coordinate these processes to address the additional
concerns of the FDA in order to allow C-TPAT/FAST members expedited processing of
food and feed shipments in addition to CBP shipments.
•
C-TPAT requirements should encompass any industry and food specific security
measures into C-TPAT’s checklist.
•
These processes must be more comprehensive.  There are no questions on the Supply
Chain Security Profile Questionnaire to specify the type of freight being hauled.  In
addition, there are no opportunities in the questionnaire to indicate different locations to
which a company is shipping regularly, or insurance a company has to cover those states.
(Response) FDA notes that CBP has continued to expand the C-TPAT program, which
now includes minimum security criteria for importers who participate in C-TPAT.  FDA also
notes that as of July 10, 2006, CBP has received over 11,000 C-TPAT applications of which
6,089 have been certified and 2,973 have been validated (certified members provide a complete
security profile that is screened by CBP, while validated members also undergo a complete
validation of their security profile that includes an on-site visit to the company to review the
submitted security profile, followed by a physical verification of security measures).  There are
limited resources at this time to add new significant program requirements to meet FDA’s needs
under the Bioterrorism Act and verify that those procedures have been incorporated.  The two
agencies will continue to explore the feasibility of the approaches recommended in the
comments in the future.
c.
Flexible alternatives:  In the FEDERAL REGISTER document to reopen the comment
period, FDA and CBP also requested comment on the following questions regarding flexible
alternatives (69 FR 19763 at 19764):

79
i. If timeframes are reduced in FDA's prior notice final rule, would other flexible
alternatives for participants in FAST or for food imported by other agencies be needed?
ii. In considering flexible alternatives for food imported by other government agencies,
what factors or criteria should FDA consider when examining alternatives? Should participation
be voluntary? If so, should FDA consider inspection of companies in the supply chain from the
manufacturer to those who may hold the product, including reviews of their security plans to
determine what procedures are in place to prevent infiltration of their facilities as a condition of
participation?
iii. In considering flexible alternatives for submission of prior notice, should FDA
consider additional means of ensuring that all companies subject to the Registration of Food
Facilities Interim Final Rule ((68 FR 58894, October 10, 2003) (21 CFR part 1, subpart H)), have
an updated registration on file with FDA that has been verified?
iv. Are there conditions of participation that FDA should consider; e.g., inspections of
companies in the supply chain from the manufacturer to those who may hold the product, or
reviews of their security plans to determine what procedures are in place to prevent infiltration of
their facilities?
v. Should the food product category be considered as a criteria or element of expedited
prior notice processing or other flexible alternatives? If so, should certain foods be excluded
from expedited prior notice processing? If so, what should be the basis for determining which
foods should be excluded?
vi. If FDA adopts reduced timeframes in the prior notice final rule, should FDA phase in
the shorter timeframes as CBP phases in the advance electronic information rule?

80
vii. Should FDA offer a prior notice submission training program for submitters and
transmitters, including brokers, to ensure the accuracy of the data being submitted?”
This section will address the comments to each of those questions introduced in the
FEDERAL REGISTER of April 14, 2004, beginning with general comments.
(Comments) One comment said that if the final rule is refined, then it is not necessary to
offer additional flexible alternatives.  Several comments state that any flexible alternatives
should be incorporated into existing programs because the duplication of security programs and
division of limited resources are not in the best interest of our security goals and the protection of
public health.
(Response) FDA believes that additional flexible alternatives should be incorporated into
existing programs when appropriate and feasible. FDA will continue to work with CBP and
acknowledges that the additional information provided by other programs such as C-TPAT could
be helpful for purposes of admissibility decisions.
i. If timeframes are reduced in FDA's prior notice final rule, would other flexible
alternatives for participants in FAST or for food imported by other agencies be needed?
(Comments) Several comments encourage incorporation of prior notice requirements into
the C-TPAT and FAST programs.  Most comments caution that additional requirements should
not be added as separate programs, but that FDA should recognize participants in the existing
programs for expedited review and processing of prior notice.  One comment further suggests
that participation in C-TPAT and FAST should also ensure expedited 801(a) admissibility
processing.  Another comment suggests that CBP be solely responsible for administering both
the FDA and CBP requirements of C-TPAT and FAST.

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(Response) As we discussed previously, we have determined not to provide C-TPAT
members with special treatment in terms of reduced prior notice information requirements or
reduced timeframes.  FDA, however, is continuing to explore with CBP and industry use of these
programs in making decisions regarding which products to inspect for the purposes of
admissibility (801(a) decisions).
FDA disagrees with the comment’s suggestion that CBP be solely responsible for
administering both the FDA and CBP requirements for these programs, as the expertise related to
food safety and possible additional participation requirements that address food safety resides in
FDA.  Accordingly, FDA and CBP will continue to consider how to administer FAST and C-
TPAT programs so that they could apply to FDA regulated products.
ii. In considering flexible alternatives for food imported by other government agencies,
what factors or criteria should FDA consider when examining alternatives? Should participation
be voluntary? If so, should FDA consider inspection of companies in the supply chain from the
manufacturer to those who may hold the product, including reviews of their security plans to
determine what procedures are in place to prevent infiltration of their facilities as a condition of
participation?
(Comments/Response) There were no comments addressing flexible alternatives for food
imported by other government agencies.  However, FDA has considered imported shipments of
foods for official U.S. federal government use and our draft policy for enforcing prior notice in
these situations is contained in the Prior Notice Final Rule Draft CPG that is announced
elsewhere in this issue of the FEDERAL REGISTER.  Under the draft policy, FDA and CBP
should typically consider not taking any regulatory action when an article of food is imported or

82
offered for import for an official government purpose, provided that a Federal Government
agency is the importer of record.
(Comments) Many comments advise that voluntary participation enhances the success of
these programs.
(Response) C-TPAT is a voluntary, incentive based partnership.  As we continue
exploring use of the C-TPAT and FAST programs in making decisions regarding which products
to inspect for the purposes of admissibility (801(a) decisions), it will be based on the assumption
that participation should remain voluntary.
iii. In considering flexible alternatives for submission of prior notice, should FDA
consider additional means of ensuring that all companies subject to the Registration of Food
Facilities Interim Final Rule ((68 FR 58894, October 10, 2003) (21 CFR part 1, subpart H)), have
an updated registration on file with FDA that has been verified?
(Comments) Several comments reiterate that it is not necessary for FDA to provide
flexible alternatives that exceed or augment CBP's existing programs, including a requirement to
have an updated and verified registration on file with FDA.  However, another comment believes
that companies eligible to participate in low-risk programs should have an updated registration
and that verification of that registration would be useful in determining low-risk status.  Another
comment assumes that verification of registration with FDA should have been conducted under
CBP’s current validation aspect of the C-TPAT program.
(Response) FDA agrees that participants designated as low risk should have an updated
and verified registration of all facilities subject to 21 CFR part 1, subpart H.  FDA also agrees it
would be efficient to conduct the verification as part of the C-TPAT validation process, but
neither FDA nor CBP has the resources to do so at this time.

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iv. Are there conditions of participation that FDA should consider; e.g., inspections of
companies in the supply chain from the manufacturer to those who may hold the product, or
reviews of their security plans to determine what procedures are in place to prevent infiltration of
their facilities?
(Comments) Most comments suggest that other conditions, such as inspection of other
companies in the supply chain would be unnecessary and a repetition of effort with little return
on investment.  Another comment states that to begin a process of examining the security plans
and procedures of foreign food facilities would be tremendously expensive, call into question the
validity of the prior notice and registration requirements already in place, and the efficacy of the
targeting tools FDA employs.
(Response) We agree that adding conditions for C-TPAT participation and validating
them to meet the purpose of the Bioterrorism Act would be extremely expensive and potentially
only benefit a small number of those entities subject to this rule.  We do not believe that this is
the best use of our limited resources at this time, particularly as we have not experienced
significant impacts on the flow of trade as a result of the timeframes in the rule since the IFR
took effect on December 12, 2003.
v. Should the food product category be considered as a criteria or element of expedited
prior notice processing or other flexible alternatives? If so, should certain foods be excluded
from expedited prior notice processing? If so, what should be the basis for determining which
foods should be excluded?
(Comments) While one comment asserts that the food product category be considered an
important element of expedited processing, most other comments state that no product category
distinctions should be made.  One comment states that to allow items imported under food

84
product categories to qualify for expedited prior notice could easily lead to abuse of the system
intended to protect us from terrorist attack.  Other comments suggest that all food products be
treated in the same manner and be subject to the same regulations.  Most comments state that no
product should be specifically included or excluded from participation, but that the criteria for
participation should be focused solely on attributes of the company and a company's ability to
meet the program standards set by the particular government agency.
(Response) FDA agrees in part that no product category distinctions should be made.
However, FDA acknowledges that some foods are more susceptible to terrorism and food safety
problems than others, regardless of the processes within the supply chain.  But if we were to
make product category distinctions, such actions could be disruptive to transportation (e.g., we
may need to segregate products) and may make such products targets for terrorism since such
products may be eligible for special (e.g., expedited) treatment.
vi. If FDA adopts reduced timeframes in the prior notice final rule, should FDA phase in
the shorter timeframes as CBP phases in the advance electronic information rule?
(Comments/Response) Comments addressing phase-in of timeframes are found under the
discussion of § 1.279 “When must prior notice be submitted to FDA.”
vii. Should FDA offer a prior notice submission training program for submitters and
transmitters, including brokers, to ensure the accuracy of the data being submitted?
(Comments/Response) Most comments support additional training for submitters and
transmitters. Additional discussion of training is found under section III. M (Outreach and
Enforcement) of this document.

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7. Additional Exclusions Requested--Samples
(Comments) Numerous comments request an exclusion from the requirements of prior
notice for samples used in trade fairs, market research, market testing, and laboratory analyses
(i.e., quality analysis/quality control (QA/QC) samples, scientific research, compositional
analyses, research and development, standard of identity confirmation testing or quality
comparison testing).  The comments state that QA/QC samples are clearly not destined for
consumption and will never enter the food chain or be consumed by the general public, thereby
placing samples in a low-risk category.  In addition, the comments note that these samples are
often imported in very small quantities for a specific purpose.  Samples used for organoleptic
analyses will be consumed in very small quantities as part of the analytic procedures in a
laboratory setting.  In the case of trade samples, the comments contend that although the food
will be consumed, the consumption is minor and is contained within a controlled environment,
such as a test kitchen or trade booth.
In addition, the comments suggest some ways in which the burdens for submitting prior
notice for samples could be less cumbersome.  These recommendations include:
•
Exempt all samples or some subset of samples, e.g., analytical, research, consumer
complaint;
•
Set a limit of the quantity of samples in each shipment and do not require prior notice for
quantities below this limit;
•
Exempt samples from the requirement to provide the manufacturer’s registration number;
•
Include a field in the prior notice in which a filer can indicate that the item(s) is a sample,
and eliminate certain data elements if this field is flagged (i.e., registration number);

86
•
Allow a single prior notice without registration numbers for commingled shipments of
many small sample items falling under the same or similar FDA product codes;
•
Allow shippers to provide a pre-approved list of customers who may receive samples in a
particular month, on a monthly basis in lieu of filing individual prior notices;
•
Specify procedures in the final rule for clearly identifying samples, such as the inclusion
of a statement on the airway bill of lading that says: “Quality Evaluation and Research
and Development Use Only – Resale Prohibited;” and
•
Provide a limited exemption for intra-corporate (within the same company) samples.
One comment requests that FDA exempt foods for exhibit at trade shows and food
samples.  The comment reasons that these foods are not intended for consumption in the United
States, but are imported for "show" and sampling at the trade shows, not for later general
consumption.  The comment further reasons that the quantity involved with each shipment is
minuscule, usually no more than five hundred consumer units, which is too small a quantity to
pose a potential national security threat.
Another comment states that there should be a de minimus provision for samples from
known shippers/importers that is “cross-referenced” by shipper facility registration, manufacturer
facility registration, importer facility registration, low value, and low weight.
(Response) Many samples of food, including those for test marketing, are “articles of
food imported or offered for import,” as stated in section 801(m) of the act.  If, however, the
samples are items that are in such early stages of research and development that they cannot yet
be considered food under § 1.276(b)(5) of the final rule, they would not be subject to prior notice
requirements.  In addition, if the sample is in a form that is not an article of food, such as a slurry
of lettuce for pesticide analysis, then prior notice requirements would not apply.  But where a

87
sample is food, as defined under prior notice, the sample is not excluded from the final rule even
if it is imported or offered for import for quality assurance, research or analysis purposes only,
not for human or animal consumption and not for resale.  However, as outlined in the Prior
Notice Final Rule Draft CPG, FDA’s and CBP’s enforcement discretion policy would apply to


Charge for the BOSC Subcommittee on Particulate Matter and Ozone Research 1.0 Objective. The objective of this review is to evaluate the relevance, quality, performance, as well as the scientific and managerial leadership of ORD's Particulate Matter and Ozone Research ( PM O3) Programs. The panel's evaluation and recommendations will provide guidance to the Office of Research and Development to help:

$ plan, implement, and strengthen the Program;

$ make research investment decisions over the next five years;

$ refine the integration of the ORD Program with those of other federal agencies $ prepare EPA's performance and accountability reports to Congress under the Government Performance and Results Act; and $ respond to evaluations of federal research such as those conducted by the Office of Management and Budget ( OMB highlights the value of recommendations from independent expert panels in guidance to federal agencies1,2).

2.0 Background Information. Independent expert review is used extensively in industry, federal agencies, Congressional committees, and academia. The National Academy of Science has recommended this approach for evaluating federal research programs. 3 Because of the nature of research, it is not possible to measure the creation of new knowledge as it develops   or the pace at which research progresses or scientific breakthroughs occur. Demonstrating research contributions to outcomes is very challenging4 when federal agencies conduct research to support regulatory decisions, and then rely on third parties5   such as state environmental agencies   to enforce the regulations and demonstrate environmental improvements. Typically, many years may be required for practical research applications to be developed and decades may be required for some research outcomes to be achieved.

Most of EPA's environmental research programs investigate complex environmental problems and processes   combining use inspired basic research6,7 with applied research, and integrating several scientific disciplines across a conceptual framework8 that links research to environmental decisions or environmental outcomes. In multi disciplinary research programs such as these, progress toward outcomes can not be measured by outputs created in a single year. Rather, research progress occurs over several years, as research teams explore hypotheses with individual studies, interpret research findings, and then develop hypotheses for future studies.

In designing and managing its research programs, ORD emphasizes the importance of identifying priority research questions to guide the research. Similarly, ORD recommends that its programs develop a small number of performance goals that serve as indicators of progress. Short term outcomes are accomplished when research is 2 applied by specific clients to strengthen environmental decisions or regulations. These decisions and resulting actions ( e. g., the reduction of contaminant emissions or the reduction of uncertainties in risk assessment) ultimately contribute to improved environmental quality and health.

In a comprehensive evaluation of science and research at EPA, the National Research Council recommended9 that the agency substantially increase its efforts to explain the significance of its research products and to assist clients inside and outside the agency in applying them. In response to this recommendation, ORD has engaged science advisors from client organizations to serve as members of its research program teams. These teams help identify research contributions with significant decision making value and help plan for their transfer and application.

For EPA's environmental research programs, periodic retrospective analysis at intervals of four or five years is needed to characterize research progress, to identify when clients are applying research to strengthen environmental decisions, and to evaluate client feedback about the research. Conducting program evaluation at this interval enables assessment of research progress, the scientific quality and decision making value of the research, and whether research progress has resulted in short term outcomes for specific clients.

In 1998, Congress augmented the budget for PM related research and mandated the establishment of a NRC Committee to assess the research needs PM. The NRC Committee has since published four reports of Research Priorities for Airborne Particulate Matter, with volume IV published in October, 2004.10 The four volumes have provided guidance to the PM Research Program in the form of an initial ten ( and eventually twelve) priority research areas ( needs). In these same reports, the NRC has submitted peer expert evaluations of the Agency's PM Research Program including its strengths and productivity, its short comings, as well as identifying challenges for the future. Since 1998, ORD has aligned its research program with the NRC priorities, evolving the relative emphases on these priorities with the development of the science, client needs, and frequent peer reviews of all or selected parts of the Program.

It is essential to appreciate that the ORD PM Program comprises an intramural research program in health and implementation, as well as an extramural ( grant funded) program, which is complimentary and integrated by design to meet the client Air Office needs. In completing the final report ( IV), the NRC provided its assessment of the PM Research Program and its accomplishments, and delineated a series of challenges for the years ahead. These challenges were provided in the presentation of the Committee Chair, Dr. Jonathan Samet of Johns Hopkins University, to ORD at the completion of Report IV. The charge to the NRC Committee reviewing the PM Program is now complete, and the formal Committee will cease to exist; but it is expected that ad hoc committees will be convened at points in the future to revisit the Program priorities and directions.

Beginning in 1997, ORD gradually redirected its long standing Ozone Research Program, initially in health and ecology, to allow for the growth and emphasis in health 3 research in PM. Agency supported ozone specific research in these areas is currently minimal. More recently, an analogous adjustment has occurred in the implementation program as well. In the latter case, the atmospheric science research in ozone and PM were merged in research of atmospheric processes and modeling, as they are inextricably linked in the air environment. With the disinvestment in the ozone specific research and its emergence in a more integrated form within the PM Program efforts in atmospheric chemistry and co pollutant health research, these two largely independent research programs have been fully merged, and is evidenced by plans to revise the Mult Year Plans ( MYP) for PM and Ozone into a merged, single MYP.

In 2003, the PM Program underwent review by OMB using a novel approach to assess program success. This review is termed the Program Assessment Rating Tool ( PART), which, in brief, focused on ( 1) the relevance of the PM Program to its clients, ( 2) the clarity and specificity of its long term goals and resultant outcomes that could be linked explicitly with measurable improvements in health and the environment, ( 3) research progress and performance, and, finally, ( 4) the resource management ensuring high quality research. Overall, the PM Program scored well in this process, except in the areas designated in ( 2) requiring demonstrated measurable outcomes in public health and the environment. As the PM and Ozone Programs have been merged and enter a second PART review, the intent is to use this BOSC assessment of the Program's new structure, its management and leadership, as well as its scientific achievements and directions to guide preparations for the PART ( spring/ summer 2004).

3.0 Draft Charge Questions for ORD's Particulate Matter  Ozone Research Program The following charge questions will help evaluate the relevance, quality, performance, as well as management and scientific leadership of ORD's Particulate Matter  Ozone Research Program:

1. Program Design and Demonstrated Leadership $ Does the new draft PM O3MYP structure reflect the identified science needs of the Program and show integration and leveraging of human and fiscal resources?

S Is the PM O3 MYP structure strategic by design, implementation and review?

S Does the PM O MYP structure provide a reasonable " road map" of the Program demonstrating a well thought out plan, identifying critical paths, clear goals, priorities and schedules?

S Is the extramural Program adequately integrated into the Program MYP and goals?

S Does the PM O3MYP structure reflect an " outcome" orientation that provides measures demonstrating the true impact on public health and the environment?

S Is the ORD PM O3 Program responsive to the recommendations of the NRC in terms of products and outputs? 4 S Are the near and long term visions of the Program consistent with the NRC noted " challenges for the future"?

$ Is ORD sufficiently coordinating research across categories of the risk assessment paradigm ( source, exposure, health, assessment, and management)?

S Is the work within the Labs and Centers integrated to maximize resource investment?

$ Is EPA ORD providing evident and appropriate science leadership and Program management?

S Are there changes or refinements in management or science leadership that are needed to improve the Program?

$ Is the EPA ORD sufficiently communicating its results to its clients and the broader scientific community?

S What can be done to improve communication and access to information by regulatory and science communities?

$ Are there important interagency or extramural collaborations that should and can be improved to advance the Agency's research agenda?

S To what extent has the EPA established and utilized other organizations ( inside and outside governments) in advancing the EPA's research agenda?

S Is the interaction and leadership role of EPA ORD with other federal agencies through the CENR effectively providing national coordination?

2. Science Quality $ Is the science being conducted by EPA ORD research Labs and Centers of recognized high quality and appropriate to the perceived needs?

$ Is program integration across Labs, Centers, and science discipline making full advantage of research opportunities?

$ Does the program ensure high quality research through competitive, merit based funding? If funds are not competitively awarded, what process does the program use to allocate funds? Does this process ensure that quality is maintained?

3. Relevance $ Does the PM O3MYP structure and Research Program clearly reflect its focus and the rationale behind its research direction and out year emphasis?

$ Are the potential public benefits in term of public health protection and pollution abatement clearly articulated?

$ Has the PM O3 Program effectively engaged stakeholders in its assessment processes, and provided useful information and tools in a timely manner?

$ Has the Program begun to establish a process for using the results of assessments, along with stakeholder feedback, to identify key research gaps and to update the Program's research agenda?

4. Demonstrated Outcomes $ Does the Program have a limited number of specific long term performance measures that focus on outcomes and meaningfully reflect the purpose of the program? 5 $ Has the Program made significant progress in the conduct of the planned research and in answering the key science questions related to public health and pollution abatement?

$ Does the Program have ambitious targets and time frames for long term measures?

S Has the Program made adequate progress in meeting its long term goals?

S Are there baselines and appropriate targets for the Program's annual measures?

S Have the Program's research products been consistent with the program's goals and supportive of client needs?

S Are the research program's findings incorporated into regulations and standards, published in the peer reviewed literature, or do they otherwise demonstrate superior scientific quality?

$ Do independent evaluations of sufficient scope and quality indicate that the Program is effective and is achieving results?

S Does the Program demonstrate improved efficiencies and cost effectiveness in achieving Program goals each year?

$ Do EPA ORD and Program leadership make adjustments in the Program's science and emphasis to meet the evolving science and research needs?

S Is the Program appropriately structured to allow for flexibility in direction and emphasis?

4.0 Potential BOSC Approach for Program Review $ Hold conference call/ s in the month preceding a face to face meeting.

 Goal: Familiarize Subcommittee with Review objectives, introduce review materials, and make assignments for face to face meeting. 1. The DFO distributes background materials and documents requested by the Subcommittee four weeks in advance of the first conference call. 2. ORD presents background materials to the Subcommittee during the first call for initial orientation; 3. The Subcommittee reviews and comments on the charge; and 4. The Subcommittee asks clarifying questions about the program under review 5. The Subcommittee Chair makes review and writing assignments to Subcommittee members in advance of a face to face meeting.

$ Hold a 2 to 3 day face to face meeting for the program review at a location where a critical mass of ORD scientists is located.

 Goal: A draft Subcommittee report is available for circulation and comment at the end of the face to face meeting that thoroughly addresses all charge questions. 1. The first segment of the meeting: ORD presentations and poster sessions, Subcommittee questions and discussion, identification of issues for further resolution. 6 2. The second segment of meeting: the subcommittee discusses prepared written assignments in context of presentations and discussion, identifies and agrees to areas for change, elaboration or other adjustment of the text as necessary. 3. The third segment of meeting: the subcommittee revises written assignments and assembles them into a draft report.

$ As necessary, hold one to two conference calls to complete the draft report in the month following the face to face meeting.

 Goal: A report approved by the Subcommittee is available for BOSC Executive Committee discussion/ approval at the May 2005 BOSC Executive Committee Meeting, with final draft completed by the end of April. 7 References 1 Budget Data Request 04 31. Executive Office of the President, Office of Management and Budget. March 22, 2004. " Completing the Program Assessment Rating Tool ( PART) for the FY06 Review Process," pages 50 56.

2 Memorandum for the Heads of Executive Departments and Agencies. Executive Office of the President, Office of Management and Budget. June 5, 2003. " FY 2005 Interagency Research and Development Priorities," pages 5 10.

3 Evaluating Federal Research under the Government Performance and Results Act ( National Research Council, 1999).

4 The House Science Subcommittee. Letter to Dr. Bruce Alberts, President of the National Academy of Sciences, from F. James Sensenbrenner, Jr. and George E. Brown. October 23, 1997.

5 The Government Performance and Results Act: 1997 Government wide Implementation Will Be Uneven. U. S. General Accounting Office. ( GAO/ GGD, 1997).

6 Building a Foundation for Sound Environmental Decisions. ( National Research Council, 1997).

7 " Renewing the Compact between Science and Government," Stokes, D. E., in 1995 Forum Proceedings, Vannevar Bush II   Science for the 21st Century. Pages 15 32. Sigma Xi, 1995.

8 Risk Assessment in the Federal Government: Managing the Process. ( National Research Council, 1983).

9 Strengthening Science at the U. S. Environmental Protection Agency. ( National Research Council, 2000, p 141).

10 National Research Council of the National Academies: Research Priorities for Airborne Particulate Matter IV, The National Academies Press, Washington, DC. 2004 ( www. nap. edu; Report IV  http:// www. nap. edu/ books/ 0309091993/ html/) 8 Appendix I OSTP/ OMB Research and Development Investment Criteria included as a PDF file.