[Federal Register Volume 88, Number 114 (Wednesday, June 14, 2023)]
[Notices]
[Pages 38870-38872]
[FR Doc No: 2023-12723]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-D-0775]

Content of Premarket Submissions for Device Software Functions;
Guidance for Industry and Food and Drug Administration Staff;
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance entitled ``Content of Premarket
Submissions for Device Software Functions.'' This guidance document is
intended to provide information regarding the recommended documentation
sponsors should include in premarket submissions for FDA's evaluation
of safety and effectiveness of device software functions, which are
functions that meet the definition of a device under the Federal Food,
Drug, and Cosmetic Act (FD&C Act). This document replaces FDA's
``Guidance for the Content of Premarket Submissions for Software
Contained in Medical Devices'' issued on May 11, 2005, and updates
FDA's thinking related to the documentation FDA recommends sponsors
include for the review of device software functions in premarket
submissions.

DATES: The announcement of the guidance is published in the Federal
Register on June 14, 2023.

ADDRESSES: You may submit either electronic or written comments on
Agency guidances at any time as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your

comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-D-0775 for ``Content of Premarket Submissions for Device
Software Functions.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    An electronic copy of the guidance document is available for
download from the internet. See the SUPPLEMENTARY INFORMATION section
for information on electronic access to the guidance. Submit written
requests for a single hard copy of the guidance document entitled
``Content of Premarket Submissions for Device Software Functions'' to
the Office of Policy, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 5431,
Silver Spring, MD 20993-0002. Send one self-addressed adhesive label to
assist that office in processing your request.

FOR FURTHER INFORMATION CONTACT: Brendan O'Leary, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 5530, Silver Spring, MD 20993-0002, 301-
796-6898; Diane Maloney, Center for Biologics Evaluation and Research,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm.
7301, Silver Spring, MD 20993,<PHONE_NUMBER>; Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Hillandale Bldg., 4th Floor, Silver Spring, MD 20993-0002, 301-796-
3400; or John Weiner, Office of Combination Products, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 32, Rm. 5130 HFG-3,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of this guidance is to describe FDA's thinking on the
recommended documentation sponsors should include in premarket
submissions for FDA's evaluation of the safety and effectiveness of
device software functions. This thinking recognizes changes to the FD&C
Act made by the 21st Century Cures Act (Cures Act), which amended
section 520 of the FD&C Act (21 U.S.C. 360j) and excludes certain
software functions from the device definition. It also considers the
rapidly evolving nature of digital health and recent FDA recognized
consensus standards related to software.
    The recommendations in this guidance are intended to facilitate
FDA's premarket review. This guidance describes information that would
be typically generated and documented during software development,
verification, and design validation. The least burdensome approach was
applied to identify the minimum amount of information that, based on
our experience, would generally be needed to support a premarket
submission for a device that uses software. During premarket review,
FDA may request additional information that is needed to evaluate the
submission.
    This document replaces FDA's ``Guidance for the Content of
Premarket Submissions for Software Contained in Medical Devices''
issued on May 11, 2005, and updates FDA's thinking related to the
documentation FDA recommends sponsors include for the review of device
software functions in premarket submissions.
    A notice of availability of the draft guidance appeared in the
Federal Register of November 4, 2021 (86 FR 60838). FDA considered
comments received and revised the guidance as appropriate in response
to the comments, including edits to clarify FDA's risk-based approach
to determining a device's Documentation Level (including an expanded
Appendix of examples that illustrate application of the Documentation
Level risk-based approach) as well as edits to clarify the recommended
documentation that should be included within a premarket submission.
The guidance also clarifies that the recommendations generally apply to
the device constituent part of a combination product when the device
constituent part includes a device software function, including
combination products assigned to FDA's Center for Drug Evaluation and
Research (CDER) or Center for Biologics Evaluation and Research (CBER)
regulated under drug or biological product market submission types. FDA
also edited the document to further clarify the recommended utilization
of FDA-recognized versions of consensus standards, where appropriate,
within a premarket submission.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
current

thinking of FDA on ``Content of Premarket Submissions for Device
Software Functions.'' It does not establish any rights for any person
and is not binding on FDA or the public. You can use an alternative
approach if it satisfies the requirements of the applicable statutes
and regulations.

II. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by
downloading an electronic copy from the internet. A search capability
for all Center for Devices and Radiological Health guidance documents
is available at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medical-devices-and-radiation-emitting-products. This guidance document is also
available at https://www.regulations.gov, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics. Persons unable to download an electronic copy of
``Content of Premarket Submissions for Device Software Functions'' may
send an email request to [email protected] to receive an
electronic copy of the document. Please use the document number
GUI00000337 and complete title to identify the guidance you are
requesting.

III. Paperwork Reduction Act of 1995

    While this guidance contains no new collection of information, it
does refer to previously approved FDA collections of information.
Therefore, clearance by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not
required for this guidance. The previously approved collections of
information are subject to review by OMB under the PRA. The collections
of information in the following FDA regulations, guidance, and forms
have been approved by OMB as listed in the following table:

------------------------------------------------------------------------
 21 CFR part; guidance; or FDA                              OMB control
              form                        Topic                 No.
------------------------------------------------------------------------
807, subpart E.................  Premarket notification.       0910-0120
814, subparts A through E......  Premarket approval.....       0910-0231
814, subpart H.................  Humanitarian Device           0910-0332
                                  Exemption.
812............................  Investigational Device        0910-0078
                                  Exemption.
860, subpart D.................  De Novo classification        0910-0844
                                  process.
601; Form FDA 356h.............  Biologics License;            0910-0338
                                  Application to Market
                                  a New or Abbreviated
                                  New Drug or Biologic
                                  for Human Use--Form
                                  FDA 356h.
``Requests for Feedback and      Q-submissions..........       0910-0756
 Meetings for Medical Device
 Submissions: The Q-Submission
 Program''.
800, 801, and 809..............  Medical Device Labeling       0910-0485
                                  Regulations.
820............................  Current Good                  0910-0073
                                  Manufacturing Practice
                                  (CGMP); Quality System
                                  (QS) Regulation.
------------------------------------------------------------------------

    Dated: June 8, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-12723 Filed 6-13-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 136 (Monday, July 16, 2018)]
[Notices]
[Pages 32853-32854]
[FR Doc No: 2018-15128]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP18-511-000]

Dakota Natural Gas, LLC; Notice of Application

    Take notice that on June 28, 2018, Dakota Natural Gas, LLC (DNG),
P.O. Box 68, Le Sueur, Minnesota 56058, filed in Docket No. CP18-511-
000 an application pursuant to section 7(f) of the Natural Gas Act
(NGA) requesting a service area determination so that it may expand or
enlarge its facilities with or without further Commission
authorization. DNG is a recently formed local distribution company
(LDC) which aims to serve customers primarily in Drayton, North Dakota.
In order to serve customers in Drayton, DNG would need to construct
approximately 17.3 miles of new pipeline facilities, of which 9.3 miles
would be located in Minnesota, running west from an interconnect with
Viking Gas Transmission Company at a Town Border Station northwest of
Donaldson, Minnesota to the Minnesota-North Dakota Border, with an
additional 1.5-mile segment running from the Minnesota-North Dakota
border to a regulator station north of Drayton. The remaining 6.5 miles
of pipeline would run south from the regulator station to the city of
Drayton. DNG also requests that the Commission determine that DNG
qualifies as an LDC for the purposes of transportation under section
311 of the Natural Gas Policy Act of 1978 and that it be granted waiver
of all reporting and accounting requirements, as well as other rules
and regulations that are normally applicable to natural gas companies
subject to the Commission's jurisdiction, all as more fully set forth
in the application which is on file with the Commission and open to
public inspection.
    The filing is available for review at the Commission in the Public
Reference Room or may be viewed on the Commission's website web at
http://www.ferc.gov using the eLibrary link. Enter the docket number
excluding the last three digits in the docket number field to access
the document. For assistance, contact FERC at
[email protected] or call toll-free,<PHONE_NUMBER> or TYY,
(202) 502-8659.
    Any questions concerning this application may be directed to Jason
T. Gray, Gray, Duncan, Weinberg, Genzer, & Pembroke, P.C., 1615 M
Street NW, Suite 800, Washington, DC 20036, by telephone at (202) 467-
6370, by fax at<PHONE_NUMBER>, or by email at [email protected].
    Pursuant to section 157.9 of the Commission's rules, 18 CFR 157.9,
within 90 days of this Notice the Commission staff will either:
Complete its environmental assessment (EA) and place it into the
Commission's public record (eLibrary) for this proceeding; or issue a
Notice of Schedule for Environmental Review. If a Notice of Schedule
for Environmental Review is issued, it will indicate, among other
milestones, the anticipated date for the Commission staff's issuance of
the final environmental impact statement (FEIS) or EA for this
proposal. The filing of the EA in the Commission's public record for
this proceeding or the issuance of a Notice of Schedule for
Environmental Review will serve to notify federal and state agencies of
the timing for the completion of all necessary reviews, and the
subsequent need to complete all federal authorizations within 90 days
of the date of issuance of the Commission staff's FEIS or EA.
    There are two ways to become involved in the Commission's review of
this project. First, any person wishing to obtain legal status by
becoming a party to the proceedings for this project should, on or
before the comment date stated below file with the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426, a
motion to intervene in accordance with the requirements of the
Commission's Rules of Practice and Procedure (18 CFR 385.214 or
385.211) and the Regulations under the NGA (18 CFR 157.10). A person
obtaining party status will be placed on the service list maintained by
the Secretary of the Commission and will receive copies of all
documents filed by the applicant and by all other parties. A party must
submit seven copies of filings made in the proceeding with the
Commission and must mail a copy to the applicant and to every other
party. Only parties to the proceeding can ask for court review of
Commission orders in the proceeding.
    However, a person does not have to intervene in order to have
comments considered. The second way to participate is by filing with
the Secretary of the Commission, as soon as

possible, an original and two copies of comments in support of or in
opposition to this project. The Commission will consider these comments
in determining the appropriate action to be taken, but the filing of a
comment alone will not serve to make the filer a party to the
proceeding. The Commission's rules require that persons filing comments
in opposition to the project provide copies of their protests only to
the party or parties directly involved in the protest.
    Persons who wish to comment only on the environmental review of
this project should submit an original and two copies of their comments
to the Secretary of the Commission. Environmental commentors will be
placed on the Commission's environmental mailing list, will receive
copies of the environmental documents, and will be notified of meetings
associated with the Commission's environmental review process.
Environmental commentors will not be required to serve copies of filed
documents on all other parties. However, the non-party commentors will
not receive copies of all documents filed by other parties or issued by
the Commission (except for the mailing of environmental documents
issued by the Commission) and will not have the right to seek court
review of the Commission's final order.
    The Commission strongly encourages electronic filings of comments,
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 7 copies of the protest or intervention to the
Federal Energy regulatory Commission, 888 First Street NE, Washington,
DC 20426.
    Comment Date: 5:00 p.m. Eastern Time on July 31, 2018.

    Dated: July 10, 2018.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2018-15128 Filed 7-13-18; 8:45 am]
 BILLING CODE 6717-01-P


Mobile Channel between
                                                                                the Arthur R. Outlaw
                                                                                Convention Center and
                                                                                Cooper Riverside Park.
9. Biannually occurring during odd     Angels Over the Bay/     Back Bay Biloxi,         Back Bay Biloxi,
 numbered years; 2 Days; Mid-March to   Keesler Air Force Base.  Biloxi, MS.              Bounded by the
 end of April.                                                                            following coordinates:
                                                                                Eastern boundary;
                                                                                Latitude
                                                                                30[deg]25'47.6'' N,
                                                                                Longitude
                                                                                088[deg]54'13.6'' W,
                                                                                to Latitude
                                                                                30[deg]24'43'' N,
                                                                                Longitude
                                                                                088[deg]54'13.6'' W.
                                                                                Western Boundary;
                                                                                Latitude
                                                                                30[deg]25'25.6'' N,
                                                                                Longitude
                                                                                088[deg]56'9'' W, to
                                                                                Latitude
                                                                                30[deg]24'55'' N,
                                                                                Longitude
                                                                                088[deg]56'9'' W.
10. 4 Days; 2nd weekend in July......  Pensacola Beach Air      Gulf of Mexico & Santa   Gulf of Mexico to
                                        Show/Santa Rosa Island   Rosa Sound, Pensacola,   include all waters
                                        Authority.               FL.                      1.75 nautical miles
                                                                                east and 1.5 nautical
                                                                                miles west of position
                                                                                30[deg]19'36'' N,
                                                                                087[deg]08'23'' W and
                                                                                extending 1000 yards
                                                                                south of Pensacola
                                                                                Beach creating a box,
                                                                                referred to as the
                                                                                ``Show Box''. Santa
                                                                                Rosa Sound to include
                                                                                all waters from Deer
                                                                                Point to Sharp Point
                                                                                and all waters within
                                                                                Little Sabine Bay.
----------------------------------------------------------------------------------------------------------------

    Dated: April 7, 2014.
Kevin Cook,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2014-09061 Filed 4-21-14; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register Volume 86, Number 36 (Thursday, February 25, 2021)]
[Notices]
[Pages 11570-11571]
[FR Doc No: 2021-03913]

=======================================================================
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DEPARTMENT OF TRANSPORTATION

Pipeline and Hazardous Materials Safety Administration

[Docket No. PHMSA-2019-0153]

Pipeline Safety: Request for Special Permit; Tejas Pipeline, LLC

AGENCY: Pipeline and Hazardous Materials Safety Administration (PHMSA);
DOT.

ACTION: Notice.

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

SUMMARY: PHMSA is publishing this notice to solicit public comments on
a request for special permit received from the Tejas Pipeline, LLC
(Tejas). The special permit request is seeking relief from compliance
with certain requirements in the Federal pipeline safety regulations.
At the conclusion of the 30-day comment period, PHMSA will review the
comments received from this notice as part of its evaluation to grant
or deny the special permit request.

DATES: Submit any comments regarding this special permit request by
March 29, 2021.

ADDRESSES: Comments should reference the docket number for this special
permit request and may be submitted in the following ways:
     E-Gov website: http://www.Regulations.gov. This site
allows the public to enter comments on any Federal Register notice
issued by any agency.
     Fax: 1-202-493-2251.
     Mail: Docket Management System: U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590.
     Hand Delivery: Docket Management System: U.S. Department
of Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE, Washington, DC 20590, between
9:00 a.m. and 5:00 p.m., Monday through Friday, except Federal
holidays.
    Instructions: You should identify the docket number for the special
permit request you are commenting on at the beginning of your comments.
If you submit your comments by mail, please submit two (2) copies. To
receive confirmation that PHMSA has received your comments, please
include a self-addressed stamped postcard. Internet users may submit
comments at http://www.Regulations.gov.
    Note: There is a privacy statement published on http://www.Regulations.gov. Comments, including any personal information
provided, are posted without changes or edits to http://www.Regulations.gov.
    Confidential Business Information: Confidential Business
Information (CBI) is commercial or financial information that is both
customarily and actually treated as private by its owner. Under the
Freedom of Information Act (FOIA) (5 U.S.C. 552), CBI is exempt from
public disclosure. If your comments responsive to this notice contain
commercial or financial information that is customarily treated as
private, that you actually treat as private, and that is relevant or
responsive to this notice, it is important that you clearly designate
the submitted comments as CBI. Pursuant to 49 Code of Federal
Regulations (CFR) Sec.  190.343, you may ask PHMSA to give confidential
treatment to information you give to the agency by taking the following
steps: (1) Mark each page of the original document submission
containing CBI as ``Confidential''; (2) send PHMSA, along with the
original document, a second copy of the original document with the CBI
deleted; and (3) explain why the information you are submitting is CBI.
Unless you are notified otherwise, PHMSA will treat such marked
submissions as confidential under the FOIA, and they will not be placed
in the public docket of this notice. Submissions containing CBI should
be sent to Kay McIver, DOT, PHMSA-PHP-80, 1200 New Jersey Avenue SE,
Washington, DC 20590-0001. Any commentary PHMSA receives that is not
specifically designated as CBI will be placed in the public docket for
this matter.

FOR FURTHER INFORMATION CONTACT:
    General: Ms. Kay McIver by telephone at<PHONE_NUMBER>, or by email
at<EMAIL_ADDRESS>    Technical: Mr. Steve Nanney by telephone at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: PHMSA received a special permit request from
Tejas, a subsidiary of Kinder Morgan, Inc., seeking a waiver from the
requirements of 49 CFR 192.611(a) and (d): Change in class location:
Confirmation or revision of maximum allowable operating pressure, and
49 CFR 192.619(a): Maximum allowable operating pressure: Steel or
plastic pipelines. This special permit is being requested in lieu of
pipe replacement or pressure reduction for one (1) pipeline segment
totaling 1,929 feet (approximately 0.37 miles) of 30-inch diameter pipe
on the King Ranch to Lovell Pipeline located in Chambers County, Texas.
The proposed special permit will allow operation of the original Class
1 pipe in the Class 3 location.
    The proposed special permit segment on the Tejas King Ranch to
Lovell Pipeline has a maximum allowable operating pressure of 703
pounds per square inch gauge and was constructed in 1958.
    The special permit request, proposed special permit with
conditions, and Draft Environmental Assessment (DEA) for the Tejas King
Ranch to Lovell Pipeline are available for review and public comments
in Docket No. PHMSA-2019-0153. PHMSA invites interested persons to
review and submit comments on the special permit request and DEA in the
docket. Please include any comments on potential safety and
environmental impacts that may result if the special permit is granted.
Comments may include relevant data.
    Before issuing a decision on the special permit request, PHMSA will
evaluate all comments received on or before the comments closing date.
Comments received after the closing date will be evaluated, if it is
possible to do so without incurring additional expense or delay. PHMSA
will consider each relevant comment it receives in making its decision
to grant or deny this special permit request.
    Issued in Washington, DC, under authority delegated in 49 CFR 1.97.

Alan K. Mayberry,
Associate Administrator for Pipeline Safety.
[FR Doc. 2021-03913 Filed 2-24-21; 8:45 am]
BILLING CODE 4910-60-P


[Federal Register Volume 81, Number 9 (Thursday, January 14, 2016)]
[Notices]
[Page 1985]
[FR Doc No: 2016-00624]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Twenty-Fifth Meeting: RTCA Special Committee (217) Aeronautical
Databases (Joint With EUROCAE WG-44)

AGENCY: Federal Aviation Administration (FAA), U.S. Department of
Transportation (DOT).

ACTION: Notice of twenty-fifth RTCA Special Committee 217 meeting.

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

SUMMARY: The FAA is issuing this notice to advise the public of the
Twenty-Fifth RTCA Special Committee 217 meeting.

DATES: The meeting will be held February 9-11, 2016 from 9:00 a.m.-5:00
p.m.

ADDRESSES: The meeting will be held at Jeppesen Office, Frankfurter
Str. 233, 63263 Neu-Isenburg, Germany, Tel:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: The RTCA Secretariat, 1150 18th Street
NW., Suite 910, Washington, DC 20036, or by telephone at (202) 833-
9339, fax at<PHONE_NUMBER>, or Web site at http://www.rtca.org or
Jennifer Iversen, Program Director, RTCA, Inc<EMAIL_ADDRESS>
(202) 330-0662.

SUPPLEMENTARY INFORMATION: Pursuant to section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463, 5 U.S.C., App.), notice is
hereby given for a meeting of RTCA Special Committee 217. The agenda
will include the following:

Tuesday, February 9, 2016 (Opening Plenary Session)

    1. Co-Chairmen's remarks and introductions
    2. Approve minutes from 24th meeting
    3. Review and approve meeting agenda for 25th meeting
    4. Schedule for this week

Tuesday-Thursday, February 9-11, 2016 (WG Sessions)

    1. Review of WG-44/SC-217 ToR and discussion on the scope of the
work
    2. Review of current ED-77/DO-201A
    a. Other related standards and initiatives
    3. ICAO-FAA-EU SES--EUROCAE/RTCA standards--ARINC 424
    4. Summary and conclusions on the updates to be made
    5. Organization of the updating effort, working arrangements and
implementation

Thursday, February 11, 2016 (Closing Plenary Session)

    1. Review of the ISRA with SC-206
    2. Meeting wrap-up: main conclusions and way forward
    3. Review of action items and next meetings
    4. Any other business and adjourn

    Attendance is open to the interested public but limited to space
availability. Use https://jeppesen.wufoo.com/forms/z1chez2i1oitnrp/ to
register to attend. With the approval of the chairman, members of the
public may present oral statements at the meeting. Plenary information
will be provided upon request. Persons who wish to present statements
or obtain information should contact the person listed in the FOR
FURTHER INFORMATION CONTACT section. Members of the public may present
a written statement to the committee at any time.

     Issued in Washington, DC, on January 11, 2016.
Latasha Robinson,
Management & Program Analyst, NextGen, Enterprise Support Services
Division, Federal Aviation Administration.
[FR Doc. 2016-00624 Filed 1-13-16; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20771-20773]
[FR Doc No: 2011-8804]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64243; File No. SR-CBOE-2011-038]

Self-Regulatory Organizations; Chicago Board Options Exchange,
Incorporated; Notice of Filing and Immediate Effectiveness of Proposed
Rule Change Regarding Close of Trading Hours for Expiring End of Week
and End of Month Expirations

April 7, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ and Rule 19b-4 thereunder,\2\ notice is hereby given that
on April 6, 2011, the Chicago Board Options Exchange, Incorporated
(``Exchange'' or ``CBOE'') filed with the Securities and Exchange
Commission (``Commission'') the proposed rule change as described in
Items I and II below, which Items have been prepared by the Exchange.
The Exchange filed the proposal as a ``non-controversial'' proposed
rule change pursuant to Section 19(b)(3)(A)(iii) of the Act \3\ and
Rule 19b-4(f)(6) thereunder.\4\ The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ 15 U.S.C. 78s(b)(3)(A)(iii).
    \4\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of the
Substance of the Proposed Rule Change

    CBOE proposes to amend Rule 24.9 to change the close of trading
hours from 3:15 p.m. (Chicago time) to 3 p.m. (Chicago time) on the
last day of trading in expiring End-of-Week and End-of Month
Expirations. The text of the rule proposal is available on the
Exchange's Web site (http://www.cboe.org/legal), at the Exchange's
Office of the Secretary and at the Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of and basis for the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The Exchange has prepared summaries, set forth in
Sections A, B, and C below, of the most significant aspects of such
statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to amend Rule 24.9 to change the close of
trading hours from 3:15 p.m. (Chicago time) to 3 p.m. (Chicago time) on
the last day of trading in expiring End-of-Week Expirations and End-of-
Month Expirations. On September 14, 2010, the Securities and Exchange
Commission (``Commission'') approved the implementation of a pilot
program that permits P.M.-settled options on broad-based indexes to
expire on (a) any Friday of the month, other than the third Friday-of-
the-month (``End-of-Week Expirations'' or ``EOWs'') and (b) the last
trading day of the month (``End-of-Month Expirations'' or ``EOMs'').\5\
---------------------------------------------------------------------------

    \5\ See Securities Exchange Act Release No. 34-62911 (September
14, 2010), 75 FR 57539 (September 21, 2010) (SR-CBOE-2009-075).
---------------------------------------------------------------------------

    EOWs and EOMs are treated the same as traditional options on the
same underlying index that expire on the Saturday following the third
Friday of the month; provided, however, that EOWs and EOMs are P.M.-
settled.\6\ EOWs and EOMs are subject to the same rules that currently
govern the trading of traditional index options, including sales
practice rules, margin requirements, and floor trading procedures.
Contract terms for EOWs and EOMs are similar to regular index options,
with one general exception: The exercise settlement value is based on
the index value derived from the closing prices of component stocks.\7\
---------------------------------------------------------------------------

    \6\ See CBOE Rule 24.9(e).
    \7\ See supra note 5.
---------------------------------------------------------------------------

    Generally, EOWs and EOMs are priced in the market based on
corresponding futures values. On the last day of trading, the closing
prices of the component stocks (which are used to derive the exercise
settlement value) are known at 3 p.m. (Chicago time) (or soon after)
when the equity markets close. Despite the fact that the exercise
settlement value is fixed at or soon after 3 p.m. (Chicago time),
trading in expiring EOWs and EOMs continues, however, for an additional
fifteen minutes until 3:15 p.m. (Chicago time) and are not priced on
corresponding futures values, but rather the known cash value. At the
same time, the prices of non-expiring EOW and EOM series continue to
move and be priced in response to changes in corresponding futures
prices.
    Because of the potential pricing divergence that could occur
between 3:00 and 3:15 pm on the final trading day in expiring EOWs and
EOMs (e.g., switch from pricing off of futures to cash), the Exchange
believes that, in order to mitigate potential investor confusion, it is
appropriate to cease trading in expiring EOWs and EOMs at 3 p.m. on the
last day of trading. The proposed change to the close of trading hours
will apply to all outstanding expiring EOW and EOM Expirations listed
on or before the effective date of this proposal and to all EOWs and
EOMs listed thereafter under the EOW/EOM Pilot Program.
2. Statutory Basis
    The Exchange believes the proposed rule change is consistent with
the Act \8\ and the rules and regulations thereunder and, in
particular, the requirements of Section 6(b) of the Act.\9\
Specifically, the Exchange believes the proposed rule change is
consistent with the Section 6(b)(5) \10\ requirements that the rules of
an exchange be designed to promote just and equitable principles of
trade, to prevent fraudulent and manipulative acts, to remove
impediments to and to perfect the mechanism for a free and open market
and a national market system, and, in general, to protect investors and
the public interest. Preventing continued trading on a product after
the exercise settlement value has been fixed eliminates potential
confusion and thereby protects investors and the public interest.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78s(b)(1).
    \9\ 15 U.S.C. 78f(b).
    \10\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

B. Self-Regulatory Organization's Statement on Burden on Competition

    CBOE does not believe that the proposed rule change will impose any
burden on competition not necessary or appropriate in furtherance of
the purposes of the Act.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants, or Others

    No written comments were solicited or received with respect to the
proposed rule change.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Because the foregoing proposed rule does not (i) significantly
affect the protection of investors or the public interest; (ii) impose
any significant burden on competition; and (iii) become operative for
30 days from the date on which it was filed, or such shorter time as
the Commission may designate if consistent with the protection of
investors and the public interest, provided that the self-regulatory
organization has given the Commission written notice of its intent to
file the proposed rule change at least five business days prior to the
date of filing of the proposed rule change or such shorter time as
designated by the Commission,\11\ the proposed rule change has become
effective pursuant to Section 19(b)(3)(A) of the Act \12\ and Rule 19b-
4(f)(6) thereunder.\13\
---------------------------------------------------------------------------

    \11\ The Exchange has satisfied this requirement.
    \12\ 15 U.S.C. 78s(b)(3)(A).
    \13\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    At any time within 60 days of the filing of such proposed rule
change, the Commission summarily may temporarily suspend such rule
change if it appears to the Commission that such action is necessary or
appropriate in the public interest, for the protection of investors, or
otherwise in furtherance of the purposes of the Act.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-CBOE-2011-038 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street, NE.,
Washington, DC

20549-1090. All submissions should refer to File No. SR-CBOE-2011-038.
This file number should be included on the subject line if e-mail is
used. To help the Commission process and review your comments more
efficiently, please use only one method. The Commission will post all
comments on the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments,
all written statements with respect to the proposed rule change that
are filed with the Commission, and all written communications relating
to the proposed rule change between the Commission and any person,
other than those that may be withheld from the public in accordance
with the provisions of 5 U.S.C. 552, will be available for Web site
viewing and printing in the Commission's Public Reference Room, 100 F
Street, NE., Washington, DC 20549, on official business days between
the hours of 10 a.m. and 3 p.m. Copies of such filing also will be
available for inspection and copying at the principal office of the
CBOE. All comments received will be posted without change; the
Commission does not edit personal identifying information from
submissions. You should submit only information that you wish to make
available publicly. All submissions should refer to File No. SR-CBOE-
2011-038 and should be submitted on or before May 4, 2011.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\14\
---------------------------------------------------------------------------

    \14\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-8804 Filed 4-12-11; 8:45 am]
BILLING CODE 8011-01-P


OPP Standard Operating Procedure

Final: January 18, 2007

 Inclusion of Water Quality & Impaired Water Body Data in

OPP’s Registration Review Risk Assessment & Management Process

Goal:  Establish a process for the voluntary submission of state &
tribal surface and ground water quality data, including but not limited
to Clean Water Act (CWA) 303(d) & 305(b) data, for consideration in
exposure characterizations for ecological risk assessments and in risk
management decisions for pesticide registration review.

Background:  EPA’s Office of Pesticide Programs (OPP) published the
final rule for pesticide registration review on August 9, 2006 with an
effective date of October 10, 2006 (ref.    HYPERLINK
"http://www.epa.gov/oppsrrd1/registration_review/"
www.epa.gov/oppsrrd1/registration_review/ ).  This program ensures that
all pesticides continue to meet current health and safety standards.
The Congressional goal is to review all existing pesticides every 15
years.

Process for Identification & Submission of Water Quality Data for
Registration Review:

Problem Formulation –begins well in advance of initiation of risk
assessment

Review schedule for opening registration review case dockets – with
focus on the first two years (e.g., FY07 & FY08 in the first schedule).
– Regional water & pesticide staff with input from OPP

Identify Clean Water Act (CWA) 303(d) listed water bodies where the
pesticide scheduled for review is the cause of impairment, and other
state/tribal water quality concerns associated with the scheduled
pesticides based on CWA 305(b) biennial reports, other surface or ground
water monitoring, or other sources.  Water quality concerns include fish
tissue and sediment concerns.  - Regional water and pesticide staff
provide a single ‘report’ per region indicating pesticides for which
data may be provided.

For registration review cases associated with 303(d) listings, mine
existing data that support the listing of each water body, and any other
related data.  Information on any current mitigation should also be
submitted.  - Regional water and pesticide staff, working with states
and tribes as appropriate.

Mine monitoring data* associated with other surface or ground water
quality concerns – EPA regional pesticide and water staff, working
with states and tribes as appropriate.

Data should conform to the quality standards in Appendix A to the extent
possible to ensure they can be used quantitatively or qualitatively in
pesticide risk assessments.

Submit all selected data, data links, or other information to OPP in
advance of the docket opening that begins the registration review
process, so that useful data can be cited and be available for public
comment.  Any data submitted later should be submitted during the public
comment period if possible.  OPP would prefer to have the submissions in
the last quarter of the fiscal year preceding the year in which the
pesticide is scheduled to begin registration review.   – Regional
water and pesticide staff, working with states, tribes and OPP as
needed.

Risk Assessment

Consider information on impaired water bodies or other water quality
data of concern in characterization of predicted ecological risks when a
revised risk assessment is needed.   – OPP, with OW and regional
consultation/collaboration  [Note:  OPP’s ecological risk assessment
may identify additional issues  beyond Clean Water Act 303(d) listings.]

Publish preliminary risk assessment for public comment along with
supporting materials (generally 60 days) and ask for comment as well on
possible/practical risk management options – OPP

Risk Management

Develop risk management options to address impaired water bodies and
other documented water quality issues, to the extent that the problem
may be attributed to use of the pesticide.  – OPP, with OW and
regional consultation/collaboration

Develop monitoring plan options as a condition of registration, based on
a determination of risks-benefits, to establish the extent to which
additional water bodies may be impaired by the chemical – OPP, with OW
and regional consultation/collaboration.

Issue Risk Management Decision – OPP

Issue an interim or final registration review decision for comment,
stating whether the pesticide meets, or does not meet, the FIFRA
standard for registration, including the basis for the proposed
findings, proposed risk mitigation standards, additional data needs,
proposed labeling changes, and deadlines to be set for completing
required actions.

Issue an interim or final registration review decision, including an
explanation of any changes and responses to significant comments.

Ensure risk mitigation measures are implemented, including label
changes.

Attachment:  Appendix A:  Options for Providing Data or Data Locations
to EPA/OPP

Appendix A:  Options for Providing Data or Data Locations to EPA/OPP

OPP Standard Operating Procedure:

Inclusion of Water Quality & Impaired Water Body Data in

OPP’s Registration Review Risk Assessment & Management Process

There are several options for providing the data or data locations to
EPA/OPP:

1.  If the data are already in the new STORET database, then simply let
OPP know where the dataset is located within the database.

2.  If the data are in legacy versions of STORET, or in other data
systems, then OPP would like to get the type of metadata and detailed
data described in the following sections.

(n.b., As a point of reference, The National Water Quality Monitoring
Council, a consortium of federal, tribal, state and local agencies,
academia, and the private and public sector water supply industries,
developed guidance on water quality data elements that enhance the
evaluation and sharing of water quality data.  The data elements
identified below were derived from this guidance (  HYPERLINK
"http://acwi.gov/methods/data_projects/index.html"
http://acwi.gov/methods/data_projects/index.html , accessed 10/2/2006).
In addition, detailed guidance on elements included in data quality
standards may be found in the Environmental Sampling, Analysis and
Results (ESAR) Data Standard issued by the Environmental Data Standards
Council:    HYPERLINK
"http://www.envdatastandards.net/content/article/detail/649?PHPSESSID=f4
d35d5d72960a91284c065c6ed71f9a"
http://www.envdatastandards.net/content/article/detail/649?PHPSESSID=f4d
35d5d72960a91284c065c6ed71f9a  )

Sample data should include at a minimum:

Bibliographic reference

Data included in an EPA risk assessment need to be citable.  The
reference would ideally be for a report on the study in which the data
were collected.  If the bibliographic citation is a website, it should
reference the page containing the data in question (not the general site
for the database), and must identify the date the page was accessed.  A
database that is on the web containing data from multiple studies is
acceptable, as long as a lead contact (i.e. study director or collecting
organization) for the study that collected the specific data in question
is provided.

Sample collection date (and time, if available)

Sample ID

Location description (Water body name in National Hydrography Dataset,
and location descriptor such as: latitude/longitude, FIPS code, water
body & segment)

Sample media (e.g. water, filtered water, bed sediment, tissue, etc.)

Concentration detected and measurement units

Detection limit and analytical method

Other important information that aid in interpreting monitoring data
are:

What was the purpose of the study (i.e. study design rationale)? (a
reconnaissance study, targeted to compounds of interest, TMDL plan,
statistically designed)

QA/QC for sample collection and analytical methods, including a
discussion of any limitations of the data

Time of sample (e.g. date, time; duration (if a composite), timing to
stream hydrograph, if flow-weighted sample)

Sample collection method (e.g. grab or composite)

Toxicity testing, if conducted.  (Include test methodology, test
species, endpoint assessed, and any toxicity identification
evaluation(s) which identified the specific toxicant(s) causing
toxicity.)

Metadata (ancillary data) are needed when using the data quantitatively,
such as

Land use, including cropping pattern, agriculture/urban, etc.

Pesticide usage that could affect water quality at sampling location

Did the sampling methodology & analytical methods go through a formal QA
process

Is the formal QA process documented (e.g. in a report or on a website
address)

For pesticides that adsorb to sediments:  percent organic carbon, bulk
density, etc.

Relevant organism parameters (size or life stage)

For some chemicals, environmental conditions may affect mobility and
persistence (for example:  temperature, pH, hardness, turbidity).  If
this is known to occur, information on the parameter would be helpful in
interpreting the data.

OPP recognizes that raw data for all the parameters listed above may not
be available in all monitoring studies, particularly for older studies,
and that the types of water quality data collected might be different
between monitoring programs.  There is no need for states to create or
reformat any data – OPP will attempt to use what is available, either
qualitatively or quantitatively.  In that spirit:

If the supporting data were collected in a monitoring program conducted
by the states themselves, OPP would like to receive the detailed
monitoring data and a copy of any report describing the purpose and
design of the monitoring study, or internet web address leading to this
information.

If the data were collected by an outside party, such as university
researchers, then citations of published reports or copies of the
reports themselves would provide the needed context.  (Note, please do
not submit NAWQA data if it was used as the basis of a 303(d) listing or
identification of a water body of concern, instead please reference the
specific NAWQA dataset.)

If any 303(d) listings or other water quality concerns for pesticides
were based on watershed characteristics or expected pesticide use, and
not actual pesticide detections in surface water, such information could
help inform OPP's risk assessment, as well.

In summary, OPP is interested in seeing all available data for a
specific water body of concern to a State.  If a monitoring study is
already contained within the new STORET all that is required is its
location within the database.  For monitoring studies not contained with
the new STORET, please submit data, or provide database locations, with
associated documentation or references, as described above.

 PAGE

 PAGE   4


[Federal Register Volume 79, Number 169 (Tuesday, September 2, 2014)]
[Notices]
[Page 52002]
[FR Doc No: 2014-20770]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2014-0002; FRL-9915-56]

SFIREG POM and EQI Committees; Notice of Public Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Association of American Pesticide Control Officials
(AAPCO)/State FIFRA Issues Research and Evaluation Group (SFIREG),
Environmental Quality Issues (EQI) Committee, and the Pesticide
Operations and Management (POM) Committee will hold 2-day meetings,
beginning on September 15, 2014 and ending September 16, 2014. This
notice announces the location and times for the meeting and sets forth
the tentative agenda topics.

DATES: The meeting will be held on Monday, September 15, 2014 from 8:30
a.m. to 5:00 p.m., and 8:30 a.m. to 12 p.m. on Tuesday, September 16,
2014.
    To request accommodation of a disability, please contact the person
listed under FOR FURTHER INFORMATON CONTACT, preferably at least 10
days prior to the meeting, to give EPA as much time as possible to
process your request.

ADDRESSES: The meeting will be held at EPA, One Potomac Yard (South
Bldg.), 2777 Crystal Dr., Arlington, VA, 4th Floor, South Conference
Room.

FOR FURTHER INFORMATION CONTACT: Ron Kendall, Field External Affairs
Division (7506P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number:<PHONE_NUMBER>; fax number:<PHONE_NUMBER>;
email address<EMAIL_ADDRESS>or Grier Stayton, SFIREG Executive
Secretary, P.O. Box 466, Milford, DE 19963; telephone number: (302)
422-8152; fax<PHONE_NUMBER>; email address: Grier Stayton at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

    You may be potentially affected by this action if you are
interested in pesticide regulation issues affecting States and any
discussion between EPA and SFIREG on FIFRA field implementation issues
related to human health, environmental exposure to pesticides, and
insight into EPA's decision-making process. You are invited and
encouraged to attend the meetings and participate as appropriate.
Potentially affected entities may include, but are not limited to:
    Those persons who are or may be required to conduct testing of
chemical substances under the Federal Food, Drug and Cosmetics Act
(FFDCA), or the Federal Insecticide, Fungicide, and Rodenticide Act
(FIFRA) and those who sell, distribute or use pesticides, as well as
any Non-Government Organization.
    If you have any questions regarding the applicability of this
action to a particular entity, consult the person listed under FOR
FURTHER INFORMATION CONTACT.

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

    The docket for this action, Identified by docket identification
(ID) number EPA-HQ-OPP-2014-0002 is available at http://www.regulations.gov, or at the Office of Pesticide Programs Regulatory
Public Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301
Constitution Ave. NW., Washington, DC 20460-0001. The Public Reading
Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday,
excluding legal holidays. The telephone number for the Public Reading
Room is<PHONE_NUMBER>, and the telephone number for the OPP Docket is
(703) 305-5805. Please review the visitor instructions and additional
information about the docket available at http://www.epa.gov/dockets.

II. Tentative Agenda Topics

     Sharing State Data with EPA-OECA.
     Cover Crop issue--National Resource Conservation Service
(NRCS) actions.
     Worker Protection Standard, Economic impact to State Lead
Agencies (SLA's).
     Developing a Pollinator Protection Program template for
AAPCO membership.
     USDA 2,4-D/Dicamba Risk Assessment--Proposed
Implementation Plans.
     Manufacturers view of Designed for the Environment
pesticide products.
     Robust discussion on the status of the Pesticides of
Interest to States (POINTS) data system.
     Current and future monitoring or evaluation actions
regarding urban pesticide use.
     Presentation on the USFWS bat and bird pesticide impact
reporting system.
     Update of aquatic risk assessment: Data requirements,
procedures, and models.

III. How can I request to participate in this meeting?

    This meeting is open for the public to attend. You may attend the
meeting without further notification.

    Dated: August 21, 2014.
Jay S. Ellenberger,
Acting Director, Field and External Affairs Division, Office of
Pesticide Programs.
[FR Doc. 2014-20770 Filed 8-29-14; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 76, Number 59 (Monday, March 28, 2011)]
[Notices]
[Pages 17121-17123]
[FR Doc No: 2011-7198]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-ORD-2011-0124; FRL-9287-1]

Human Studies Review Board (HSRB); Notification of a Public
Meeting

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The U.S. Environmental Protection Agency (EPA) Office of the
Science Advisor (OSA) announces a public meeting of the HSRB to advise
the Agency on EPA's scientific and ethical reviews of research with
human subjects.

DATES: This public meeting will be held on April 13-14, 2011, from
approximately 8:30 a.m. to approximately 5 p.m. Eastern Time.

ADDRESSES: Submit your written comments, identified by Docket ID No.
EPA-HQ-ORD-2011-0124, by one of the following methods:
    Internet: http://www.regulations.gov: Follow the on-line
instructions for submitting comments.
    E-mail<EMAIL_ADDRESS>    Mail: Environmental Protection Agency, EPA Docket Center (EPA/DC),
ORD Docket, Mailcode: 28221T, 1200 Pennsylvania Avenue NW., Washington,
DC 20460.
    Hand Delivery: The EPA/DC Public Reading Room is located in the EPA
Headquarters Library, Room Number 3334 in the EPA West Building,
located at 1301 Constitution Avenue NW., Washington, DC 20460. The
hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time, Monday
through Friday, excluding Federal holidays. Please call<PHONE_NUMBER>
or e-mail the ORD Docket at<EMAIL_ADDRESS>for instructions.
Updates to Public Reading Room access are available on the Web site
(http://www.epa.gov/epahome/dockets.htm).
    Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-
2011-0124. EPA's policy is that all comments received will be included
in the public docket without change and may be made available online at
http://www.regulations.gov, including any personal information
provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information the
disclosure of which is restricted by statute. Do not submit information
that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site
is an ``anonymous access'' system, which means EPA will not know your
identity or contact information unless you provide it in the body of
your comment. If you send an e-mail comment directly to EPA without
going through http://www.regulations.gov, your e-mail address will be
automatically captured and included as part of the comment that is
placed in the public docket and made available on the Internet. If you
submit an electronic comment, EPA recommends that you include your name
and other contact information in the body of your comment and with any
disk or CD-ROM you submit. If EPA cannot read your comment due to

technical difficulties and cannot contact you for clarification, EPA
may not be able to consider your comment. Electronic files should avoid
the use of special characters, any form of encryption, and be free of
any defects or viruses.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wishes to
receive further information should contact Jim Downing at telephone
number:<PHONE_NUMBER>; fax:<PHONE_NUMBER>; e-mail address:
<EMAIL_ADDRESS>or Lu-Ann Kleibacker at telephone number: (202)
564-7189; fax:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
mailing address: Environmental Protection Agency, Office of the Science
Advisor (8105R), 1200 Pennsylvania Avenue NW., Washington, DC 20460.
General information concerning the EPA HSRB can be found on the EPA Web
site at http://www.epa.gov/osa/hsrb/.

SUPPLEMENTARY INFORMATION:
    Location: Holiday Inn National Airport, 2650 Jefferson Davis
Highway, Arlington, VA 22202.
    Meeting access: Seating at the meeting will be on a first-come
basis. To request accommodation of a disability, please contact the
persons listed under FOR FURTHER INFORMATION CONTACT at least ten
business days prior to the meeting using the information under FOR
FURTHER INFORMATION CONTACT, so that appropriate arrangements can be
made.
    Procedures for providing public input: Interested members of the
public may submit relevant written or oral comments for the HSRB to
consider during the advisory process. Additional information concerning
submission of relevant written or oral comments is provided in section
I. ``Public Meeting,'' under subsection D. ``How May I Participate in
this Meeting?'' of this notice.

I. Public Meeting

A. Does this action apply to me?

    This action is directed to the public in general. This action may,
however, be of particular interest to persons who conduct or assess
human studies, especially studies on substances regulated by EPA, or to
persons who are, or may be required to conduct testing of chemical
substances under the Federal Food, Drug, and Cosmetic Act (FFDCA) or
the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Since
other entities may also be interested, the Agency has not attempted to
describe all the specific entities that may be affected by this action.
If you have any questions regarding the applicability of this action to
a particular entity, consult Jim Downing or Lu-Ann Kleibacker listed
under FOR FURTHER INFORMATION CONTACT.

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

    In addition to using regulations.gov, you may access this Federal
Register document electronically through the EPA Internet under the
Federal Register listings at http://www.epa.gov/fedrgstr/.
    Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some
information is not publicly available, e.g., CBI or other information
whose disclosure is restricted by statute. Certain other material, such
as copyrighted material, will be publicly available only in hard copy.
Publicly available docket materials are available either electronically
in http://www.regulations.gov or in hard copy at the ORD Docket, EPA/
DC, Public Reading Room. The EPA/DC Public Reading Room is located in
the EPA Headquarters Library, Room Number 3334 in the EPA West
Building, located at 1301 Constitution Avenue NW., Washington, DC
20460. The hours of operation are 8:30 a.m. to 4:30 p.m. Eastern Time,
Monday through Friday, excluding Federal holidays. Please call (202)
566-1744 or e-mail the ORD Docket at<EMAIL_ADDRESS>for
instructions. Updates to Public Reading Room access are available on
the Web site (http://www.epa.gov/epahome/dockets.htm). EPA's position
paper(s), charge/questions to the HSRB, and the meeting agenda will be
available by the end of March 2011. In addition, the Agency may provide
additional background documents as the materials become available. You
may obtain electronic copies of these documents, and certain other
related documents that might be available electronically, from the
regulations.gov Web site and the EPA HSRB Web site at http://www.epa.gov/osa/hsrb/. For questions on document availability, or if
you do not have access to the Internet, consult either Jim Downing or
Lu-Ann Kleibacker listed under FOR FURTHER INFORMATION CONTACT.

C. What should I consider as I prepare my comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data that you
used to support your views.
    4. Provide specific examples to illustrate your concerns and
suggest alternatives.
    5. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

D. How may I participate in this meeting?

    You may participate in this meeting by following the instructions
in this section. To ensure proper receipt by EPA, it is imperative that
you identify docket ID number EPA-HQ-ORD-2011-0124 in the subject line
on the first page of your request.
    1. Oral comments. Requests to present oral comments will be
accepted up to Wednesday, April 6, 2011. To the extent that time
permits, interested persons who have not pre-registered may be
permitted by the Chair of the HSRB to present oral comments at the
meeting. Each individual or group wishing to make brief oral comments
to the HSRB is strongly advised to submit their request (preferably via
email) to Jim Downing or Lu-Ann Kleibacker, under FOR FURTHER
INFORMATION CONTACT, no later than noon, Eastern Time, Wednesday, April
6, 2011, in order to be included on the meeting agenda and to provide
sufficient time for the HSRB Chair and HSRB Designated Federal Official
(DFO) to review the meeting agenda to provide an appropriate public
comment period. The request should identify the name of the individual
making the presentation and the organization (if any) the individual
will represent. Oral comments before the HSRB are generally limited to
five minutes per individual or organization. Please note that this
includes all individuals appearing either as part of, or on behalf of,
an organization. While it is our intent to hear a full range of oral
comments on the science and ethics issues under discussion, it is not
our intent to permit organizations to expand the time limitations by
having numerous individuals sign up separately to speak on their
behalf. If additional time is available, further public comments may be
possible.
    2. Written comments. Submit your written comments prior to the
meeting. For the HSRB to have the best opportunity to review and
consider your comments as it deliberates on its report, you should
submit your comments at least five business days prior to the beginning
of this meeting. If you submit

comments after this date, those comments will be provided to the Board
members, but you should recognize that the Board members may not have
adequate time to consider those comments prior to making a decision.
Thus, if you plan to submit written comments, the Agency strongly
encourages you to submit such comments no later than noon, Eastern
Time, Wednesday, April 6, 2011. You should submit your comments using
the instructions in section I., under subsection C., ``What Should I
Consider as I Prepare My Comments for EPA?'' In addition, the Agency
also requests that persons submitting comments directly to the docket
also provide a copy of their comments to Jim Downing or Lu-Ann
Kleibacker listed under FOR FURTHER INFORMATION CONTACT. There is no
limit on the length of written comments for consideration by the HSRB.

E. Background

    The HSRB is a Federal advisory committee operating in accordance
with the Federal Advisory Committee Act (FACA) 5 U.S.C. App.2 Sec.  9.
The HSRB provides advice, information, and recommendations to EPA on
issues related to scientific and ethical aspects of human subjects
research. The major objectives of the HSRB are to provide advice and
recommendations on: (1) Research proposals and protocols; (2) reports
of completed research with human subjects; and (3) how to strengthen
EPA's programs for protection of human subjects of research. The HSRB
reports to the EPA Administrator through EPA's Science Advisor.
    1. Topics for discussion. At its meeting on April 13 and 14, 2011,
EPA's Human Studies Review Board will consider scientific and ethical
issues surrounding these topics:
    a. The report of a completed scenario monograph and study reports
from the Agricultural Handler Exposure Task Force (AHETF) measuring the
dermal and inhalation exposure of professional agricultural workers
applying liquid spray pesticides to tree or trellis crops using open
cab airblast equipment.
    b. The report of a completed scenario monograph and study report
from the Antimicrobial Exposure Assessment Task Force II (AEATF) in
which the dermal and inhalation exposure of professional janitorial
workers was monitored as they applied a liquid antimicrobial product to
indoor surfaces using a trigger spray bottle and wipes or ready-to-use
wipes.
    c. A published report by Gulson et al (2010) of an intentional
exposure human study measuring dermal absorption of zinc oxides
contained in sunscreen.
    d. A reevaluation of an intentional human dosing study with
chlorpyrifos (Kisicki) previously reviewed by the HSRB; pertinent new
information from the sponsor has been made available.
    2. Meeting minutes and reports. Minutes of the meeting, summarizing
the matters discussed and recommendations, if any, made by the advisory
committee regarding such matters, will be released within 90 calendar
days of the meeting. Such minutes will be available at http://www.epa.gov/osa/hsrb/ and http://www.regulations.gov. In addition,
information concerning a Board meeting report, if applicable, can be
found at http://www.epa.gov/osa/hsrb/ or from the person listed under
FOR FURTHER INFORMATION CONTACT.

    Dated: March 23, 2011.
Paul T. Anastas,
EPA Science Advisor.
[FR Doc. 2011-7198 Filed 3-25-11; 8:45 am]
BILLING CODE 6560-50-P


Executive Summary

Overview

EPA has performed an illustrative analysis of the potential costs and
human health benefits of nationally attaining alternative ozone
standards. Per Executive Order 12866 and the guidelines of OMB Circular
A-4, this Regulatory Impact Analysis (RIA) presents analyses of the
range of standards proposed by the Administrator in the Notice of
Proposed Rulemaking (0.070 – 0.075 ppm), as well as one more stringent
option (0.065 ppm).  The less stringent option is the baseline, or the
current primary standard for ozone (0.08 ppm, effectively 0.084 ppm due
to current rounding conventions).  The benefit and cost estimates below
are calculated incremental to a 2020 baseline that incorporates air
quality improvements achieved through the projected implementation of
existing regulations and full attainment of the existing ozone and
particulate matter (PM) National Ambient Air Quality Standards  (NAAQS).
 The baseline includes the Clean Air Interstate Rule and mobile source
programs, which will help many areas move toward attainment of the
current standard.

We present two sets of results.  The first reflects full attainment of
the alternative ozone standards in all locations of the U.S. except two
areas of California in 2020.  These two areas of California are not
planning to meet the current standard by 2020, so the estimated costs
and benefits for these areas are based on reaching an estimated
attainment point in 2020 (their “glidepath” targets).  The second
set of results, for California only, estimate the costs and benefits
from California fully attaining the alternative standards in a year
beyond 2020 (glidepath estimates, plus the increment needed to reach
full attainment beyond 2020, added together for a California total).
Further explanation about these unique circumstances is provided in
Chapter 4.

In addition, EPA designed a two-stage approach to estimating costs and
benefits because we recognized from the outset that known and reasonably
anticipated emissions controls would likely be insufficient to bring
many areas into attainment with either the current, or alternative, more
stringent ozone standards.  The individual chapters of the RIA present
more detail regarding estimated costs and benefits based on both partial
attainment (manageable with current technologies) and full attainment
(manageable in some locations only with hypothetical technologies).  The
post-2020 estimates for California are entirely based on hypothetical
technologies.

In setting primary ambient air quality standards, EPA’s responsibility
under the law is to establish standards that protect public health. The
Clean Air Act (“Act”) requires EPA, for each criteria pollutant, to
set a standard that protects public health with “an adequate margin of
safety.” As interpreted by the Agency and the courts, the Act requires
EPA to base this decision on health considerations only; economic
factors cannot be considered.

The prohibition against the consideration of cost in the setting of the
primary air quality standards, however, does not mean that costs,
benefits or other economic considerations are unimportant or should be
ignored. The Agency believes that consideration of costs and benefits is
an essential decision making tool for the efficient implementation of
these standards. The impacts of cost, benefits, and efficiency are
considered by the States when they make decisions regarding what
timelines, strategies, and policies make the most sense.

This RIA is focused on development and analyses of illustrative control
strategies to meet these alternative standards in 2020.  This analysis
does not prejudge the attainment dates that will ultimately be assigned
to individual areas under the Clean Air Act, which contains a variety of
potential dates and flexibility.  For purposes of this analysis, though,
we assume attainment by 2020 for all areas except for two areas in
California

Because States are ultimately responsible for implementing strategies to
meet revised standards, this RIA provides insights and analysis of a
limited number of illustrative control strategies that states might
adopt to meet any revised standard.  These illustrative strategies are
subject to a number of important assumptions, uncertainties and
limitations, which we document in the relevant portions of the analysis.

ES.1	Approach to the Analysis

This RIA consists of multiple analyses including an assessment of the
nature and sources of ambient ozone; estimates of current and future
emissions of relevant precursors that contribute to the problem; air
quality analyses of baseline and alternative strategies; development of
illustrative control strategies to attain the standard alternatives in
future years; estimates of the incremental costs and benefits of
attaining the alternative standards, together with an examination of key
uncertainties and limitations; and a series of conclusions and insights
gained from the analysis.

The air quality modeling results for the regulatory baseline (explained
in Chapter 3) provide the starting point for developing illustrative
control strategies to attain the alternative standards that are the
focus of this RIA.    The baseline shows that by 2020, while ozone air
quality would be significantly better than today under current
requirements, several eastern and western states would need to develop
and adopt additional controls to attain the alternative standards.

In selecting controls, we focused more on ozone cost-effectiveness
(measured as $/ ppb) than on the NOx or VOC cost-effectiveness (measured
as $/ton).  Most of the overall reductions in NOx achieved our
illustrative control strategy were from non-EGU point sources.  The NOx
based illustrative control strategies we analyzed are also expected to
reduce ambient PM 2.5 levels in many locations.  The total benefits
estimates described here include the co-benefits of reductions in fine
particulate levels (PM) associated with year-round application of NOx
control strategies beyond those in the regulatory baseline.

Estimated reductions in premature mortality from reductions in ambient
ozone and PM dominate the benefits estimates.  For this reason, our
assessment provides a range of estimates for both PM and ozone premature
mortality.  Although we note that there are uncertainties that are not
fully captured by this range of estimates, and that additional research
is needed to more fully establish underlying mechanisms by which such
effects occur, such ranges are illustrative of the extent of uncertainly
associated with some different modeling assumptions.

	Fig ES.1  Projected Ozone Air Quality in 2020 After Application of
Known Controls

1 Modeled emissions reflect the expected reductions from federal
programs including the Clean Air Interstate Rule, the Clean Air Mercury
Rule, the Clean Air Visibility Rule, the Clean Air Nonroad Diesel Rule,
the Light-Duty Vehicle Tier 2 Rule, the Heavy Duty Diesel Rule, proposed
rules for Locomotive and Marine Vessels and for Small Spark-Ignition
Engines, and state and local level mobile and stationary source controls
identified for additional reductions in emissions for the purpose of
attaining the current PM 2.5 and Ozone  standards.

2 Controls applied are illustrative.  States may choose to apply
different control strategies for implementation.

3 The current standard of 0.08 ppm is effectively expressed as 0.084 ppm
when rounding conventions are applied.

4 Modeled design values in ppm are only interpreted up to 3 decimal
places.

5 Map shows results from a total of 491 counties with projected design
values. Consistent with current modeling guidance, EPA did not project
2020 concentrations for counties where 2001 base year concentrations
were less than recommended criterion.  Such projections may not
represent expected future levels.

ES-2.	Results of Benefit-Cost Analysis

There are two sets of results presented below.  The first set of
national results assumes attainment of revised standards by 2020 in all
areas, except for two areas in Southern California.   It is expected
that benefits and costs will begin occurring earlier, as states begin
implementing control measures to show progress towards attainment. Some
areas with high ozone levels, such as the two areas in Southern
California, are not planning to attain even the current standard until
after 2020.  In these locations, our national 2020 estimate includes the
cost and benefits of reaching an estimated progress point in  2020
(known as a “glidepath” target).  The 2020 results will thus not
represent a true “full attainment” scenario for the entire nation.
In order to gain an understanding of the possible additional costs and
benefits of fully attaining in California in a year beyond 2020, we
provide an additional set of results for California only.  Tables ES-1
to ES-3 present national benefits and costs in 2020, including the
“glidepath” targets for California; companion Table ES-4 provides
the national estimated reductions in premature mortality and morbidity
in 2020, including the “glidepath” targets for California.

Tables ES-5 to ES-7 present the costs and benefits of full attainment
for California (“glidepath” in 2020 plus the additional increment
achieved between 2020 and a future year added together into one
California total); Table ES-8 is the companion table showing estimated
reductions in premature mortality and morbidity for California.  Because
various mobile source rules, such as the onroad and nonroad diesel rule,
among others, would be expected to be implemented between 2020 and a
future year, the tons of emission reduction expected to occur as a
result of those rules has been taken out of the calculated costs and
benefits for the estimates of additional tons of emission reduction
needed in California between 2020 and a future year.  EPA did the
analysis this way because to force full attainment in an earlier year
than would be required under the Clean Air Act would likely lead to an
overstatement of costs because those areas might benefit from these
existing federal or state programs that would be implemented between
2020 and the attainment year; because additional new technologies may
become available between 2020 and the attainment year; and because the
cost of existing technologies might fall over time.  As such, we use the
best available data to estimate costs and benefits of full attainment
for California in a future year, while recognizing that the estimates of
costs and benefits for California in a year between 2020 and a future
year are likely to be relatively more uncertain than the national
attainment estimates for 2020.  It is not appropriate to add together
the 2020 national attainment, California glidepath estimate and the
estimate of California full attainment as an estimate of national full
attainment in 2020.  The extra increment of attainment that is estimated
for California will not occur in 2020, so it is not accurate to add it
to our nationwide estimate of the “glidepath” benefits and costs to
arrive at a “full attainment” estimate for 2020.  It is also not
accurate to add the two estimates together to arrive at an estimate of
future, post-2020 full attainment benefits and costs, because our
nationwide full attainment estimates do not allow other areas of the
nation to take credit for the reductions in NOx from the mobile source
rules that will occur after 2020.

In these tables, the individual row estimates reflect the different
studies available to describe the ozone premature mortality
relationship.  Ranges within the total benefits column reflect
variability in the studies upon which the estimates associated with
premature mortality were derived.  PM co-benefits account for between 13
and 99 percent of co-benefits, depending on the standard analyzed and on
the choice of ozone and PM mortality functions used.

Ranges in the total costs column reflect different assumptions about the
extrapolation of costs.  The low end of the range of net benefits is
constructed by subtracting the highest cost from the lowest benefit,
while the high end of the range is constructed by subtracting the lowest
cost from the highest benefit.  The presentation of the net benefit
estimates represents the widest possible range from this analysis.

Table ES-1  National Annual Costs and Benefits:  0.079 ppm Standard in
2020

(including California glidepath )

Premature Mortality Function or Assumption	Reference	Mean Total
Benefits, in Billions of 1999$

Total Benefits*	Total Costs**	Net Benefits

NMMAPS	Bell et al. 2004	$1.2 to $11	$3 to $3.3	-$2.1 to $8.5

Meta-analysis	Bell et al. 2005	$1.6 to $12	$3 to $3.3	-$1.7 to $8.9

	Ito et al. 2005	$1.7 to $12	$3 to $3.3	-$1.7 to $8.9

	Levy et al. 2005	$1.6 to $12	$3 to $3.3	-$1.7 to $8.9

Assumption that association is not causal***	$1.1 to $11	$3 to $3.3
-$2.2 to $8.4

Table ES-2  National Annual Costs and Benefits:  0.075 ppm Standard in
2020

(including California glidepath )

Premature Mortality Function or Assumption	Reference	Mean Total
Benefits, in Billions of 1999$

Total Benefits*	Total Costs**	Net Benefits

NMMAPS	Bell et al. 2004	$3 to $16	$5.5 to $8.8	-$5.8 to $10.5

Meta-analysis	Bell et al. 2005	$7.3 to $20	$5.5 to $8.8	-$1.5 to $15

	Ito et al. 2005	$7.8 to $21	$5.5 to $8.8	-$1. to $15

	Levy et al. 2005	$8.7 to $22	$5.5 to $8.8	-$0.1 to $16

Assumption that association is not causal***	$1.5 to $15	$5.5 to $8.8
-$7.3 to $9

Table ES-3  National Annual Costs and Benefits:  0.070 ppm Standard in
2020

(including California glidepath)

Premature Mortality Function or Assumption	Reference	Mean Total
Benefits, in Billions of 1999$

Total Benefits*	Total Costs**	Net Benefits

NMMAPS	Bell et al. 2004	$4.3 to $26	$10 to $22	-$17 to $16

Meta-analysis	Bell et al. 2005	$9.7 to $31	$10 to $22	-$12 to $21

	Ito et al. 2005	$10 to $32	$10 to $22	-$11 to $22

	Levy et al. 2005	$11 to $33	$10 to $22	-$10 to $23

Assumption that association is not causal***	$2.5 to $24	$10 to $22	-$20
to $14

Table ES-4  National Annual Costs and Benefits :  0.065 ppm Standard in
2020

(including California glidepath)

Premature Mortality Function or Assumption	Reference	Mean Total
Benefits, in Billions of 1999$

Total Benefits*	Total Costs**	Net Benefits

NMMAPS	Bell et al. 2004	$7.7  to $45	$17 to $46	-$38 to $28

Meta-analysis	Bell et al. 2005	$18 to $55	$17 to $46	-$28 to $38

	Ito et al. 2005	$19 to $56	$17 to $46	-$27 to $39

	Levy et al. 2005	$20 to $57	$17 to $46	-$27 to $40

Assumption that association is not causal***	$4.3 to $42	$17 to $46	-$42
to $25

*Includes ozone benefits, and PM 2.5 co-benefits. Range was developed by
adding the estimate from the ozone premature mortality function to both
the lower and upper ends of the range of the PM2.5 premature mortality
functions characterized in the expert elicitation

**Range reflects lower and upper bound cost estimates

***Total includes ozone morbidity benefits only

Table ES-5: Summary of Total Number of Annual Ozone and PM2.5-Related
Premature Mortalities and Premature Morbidity Avoided: 2020 National
Benefits

Combined Estimate of Mortality

Standard Alternative and

Model or Assumption	Combined Range of Ozone Benefits and

 PM2.5 Co-Benefits

0.079 ppm	0.075 ppm	0.070 ppm	0.065 ppm

NMMAPS 	Bell (2004)	200 to 1,900	430 to 2,600	670 to 4,300	1,200 to
7,400

Meta-Analysis	Bell (2005)	260 to 2,000	1,100 to 3,300	1,500 to 5,100
2,800 to 9,000

	Ito (2005)	270 to 2,000	1,200 to 3,300	1,600 to 5,200	3,000 to 9,200

	Levy (2005)	260 to 2,000	1,300 to 3,500	1,800 to 5,400	3,000 to 9,200

No Causality	180 to 1,900	230 to 2,400	390 to 4,000	660 to 6,900

	Combined Estimate of Morbidity

	Acute Myocardial Infarction	1,100	1,400	2,300	4,000

Hospital and ER Visits	1,300	5,600	7,600	13,000

Chronic Bronchitis	370	470	780	1,300

Acute Bronchitis	950	1,200	2,000	3,500

Asthma Exacerbation	7,300	9,400	16,000	27,000

Lower Respiratory Symptoms	8,100	10,000	17,000	29,000

Upper Respiratory Symptoms	5,900	7,500	13,000	22,000

School Loss Days	50,000	610,000	780,000	1,300,000

Work Loss Days	51,000	65,000	110,000	190,000

Minor Restricted Activity Days	430,000	2,000,000	2,700,000	4,700,000

Table ES-6   California:  Annual Costs and Benefits of Attaining 0.079
ppm Standard (beyond 2020)*

Premature Mortality Function

or Assumption	Reference	Mean Total Benefits, in Billions of 1999$

Total Benefits**	Total Costs***	Net Benefits

NMMAPS	Bell et al. 2004	$0.1 to $0.6	$0.3 to $1.7	-$1.6 to $0.2

Meta-analysis	Bell et al. 2005	$0.2 to $0.7	$0.3 to $1.7	-$1.5 to $0.4

	Ito et al. 2005	$0.3 to $0.7	$0.3 to $1.7	-$1.4 to $0.4

	Levy et al. 2005	$0.2 to $0.7	$0.3 to $1.7	-$1.5 to $0.4

Assumption that association is not causal****	$0.05 to $0.5	$0.3 to $1.7
-$1.6 to $0.2

Table ES-7   California:  Annual Costs and Benefits of Attaining 0.070
ppm Standard (beyond 2020)*

Premature Mortality Function

or Assumption	Reference	Mean Total Benefits, in Billions of 1999$

Total Benefits**	Total Costs***	Net Benefits

NMMAPS	Bell et al. 2004	$0.7 to $3.5	$2 to $13	-$12 to $1.5

Meta-analysis	Bell et al. 2005	$1.9 to $4.7	$2 to $13	-$11 to $2.7

	Ito et al. 2005	$2.1 to $4.8	$2 to $13	-$11 to $2.9

	Levy et al. 2005	$2.1 to $4.8	$2 to $13	-$11 to $2.9

Assumption that association is not causal****	$0.4 to $3.1	$2 to $13
-$13 to $1.2

Table ES-8   California:  Annual Costs and Benefits of  Attaining 0.075
ppm Standard (beyond 2020)*

Premature Mortality Function

or Assumption	Reference	Mean Total Benefits, in Billions of 1999$

Total Benefits**	Total Costs***	Net Benefits

NMMAPS	Bell et al. 2004	$0.4 to $1.9	$1.1 to $6.2	-$5.8 to $0.8

Meta-analysis	Bell et al. 2005	$1.1 to $2.6	$1.1 to $6.2	-$5.1 to $1.5

	Ito et al. 2005	$1.2 to $2.7	$1.1 to $6.2	-$5.1 to $1.6

	Levy et al. 2005	$1.2 to $2.7	$1.1 to $6.2	-$5 to $1.6

Assumption that association is not causal****	$0.2 to $1.7	$1.1 to $6.2
-$6 to $0.6

Table ES-9   California:  Annual Costs and Benefits of Attaining 0.065
ppm Standard (beyond 2020)*

Premature Mortality Function

or Assumption	Reference	Mean Total Benefits, in Billions of 1999$

Total Benefits**	Total Costs***	Net Benefits

NMMAPS	Bell et al. 2004	$1.1 to $5.2	$2.9 to $21	-$19 to $2.3

Meta-analysis	Bell et al. 2005	$3.1 to $7.2	$2.9 to $21	-$17 to $4.3

	Ito et al. 2005	$3.4 to $7.4	$2.9 to $21	-$17 to $4.5

	Levy et al. 2005	$3.3 to $7.4	$2.9 to $21	-$17 to $4.5

Assumption that association is not causal****	$0.5 to $4.6	$2.9 to $21
-$20 to $1.7

* Tables present the total of CA glidepath in 2020, plus the additional
increment needed to reach full attainment in a year beyond 2020

** Includes ozone benefits and PM 2.5 co-benefits.  Range was developed
by adding the estimate from the ozone premature mortality function to
both the lower and upper ends of the range of the PM2.5 premature
mortality functions characterized in the expert elicitation

***Range reflects lower and upper bound cost estimates

****Total includes ozone morbidity benefits only

Table ES-10: Summary of Total Number of Annual Ozone and PM2.5-Related
Premature Mortalities and Premature Morbidity Avoided: California Post
2020 Attainment

Combined Estimate of Mortality

Standard Alternative and

Model or Assumption	Combined Range of Ozone Benefits and

 PM2.5 Co-Benefits

0.079 ppm	0.075 ppm 	0.070 ppm	0.065 ppm

NMMAPS 	Bell (2004)	17 to 93	61 to 310	110 to 570	180 to 840

Meta-Analysis	Bell (2005)	42 to 120	170 to 410	300 to 760	490 to 1,200

	Ito (2005)	45 to 120	180 to 430	320 to 780	530 to 1,200

	Levy (2005)	46 to 120	180 to 430	320 to 780	520 to 1,200

No Causality	8.2 to 84	26 to 270	49 to 500	72 to 740

	Combined Estimate of Morbidity

	Acute Myocardial Infarction	49	160	290	430

Hospital and ER Visits	200	790	1,400	2,200

Chronic Bronchitis	17	53	99	150

Acute Bronchitis	43	140	260	380

Asthma Exacerbation	330	1,100	2,000	2,900

Lower Respiratory Symptoms	360	1,200	2,200	3,200

Upper Respiratory Symptoms	270	850	1,600	2,300

School Loss Days	30,000	120,000	210,000	340,000

Work Loss Days	2,300	7,400	14,000	20,000

Minor Restricted Activity Days	87,000	340,000	600,000	960,000

***Range was developed by adding the estimate from the ozone premature
mortality function to both the lower and upper ends of the range of the
PM2.5 premature mortality functions characterized in the expert
elicitation

ES-3. 	Caveats and Conclusions

Of critical importance to understanding these estimates of future costs
and benefits is that they not intended to be forecasts of the actual
costs and benefits of implementing revised standards. There are many
challenges in estimating the costs and benefits of attaining a tighter
ozone standard, which are fully discussed in Chapter 8.  Analytically,
the characterization of ozone mortality benefits and the estimation of
the costs and benefits of the nation fully attaining a tighter standard
are being subject to further review by science advisory boards.

There are significant uncertainties in both cost and benefit estimates.
Below we summarize some of the more significant sources of uncertainty.

Benefits estimates are influenced by our ability to correctly model
relationships between ozone and PM and their associated health effects
(e.g., premature mortality).

Benefits estimates are also heavily dependent upon the choice of
statistical estimates for values associated with each of the health
benefits.

EPA has requested advice from the National Academy of Sciences on how
best to quantify uncertainty in the relationship between ozone exposure
and premature mortality in the context of quantifying benefits
associated with alternative ozone control strategies.

PM co-benefits are derived primarily from reductions in nitrates
(associated with NOx controls).  As such, these estimates are strongly
influenced by the assumption that all PM components are equally toxic.
Co-benefit estimates are also influenced by the extent to which a
particular area chooses to use NOx controls rather than VOC controls.

There are several nonquantified benefits (e.g. effects of reduced ozone
on forest health and agricultural crop production) and disbenefits (e.g.
decreases in tropospheric ozone lead to reduced screening of UV-B rays
and reduced nitrogen fertilization of forests and cropland) discussed in
this analysis in chapter 6.

Changes in air quality as a result of controls are not expected to be
uniform over the country.  In our hypothetical control scenario some
increases in ozone levels occur in areas already in attainment, though
not enough to push the areas into nonattainment

As explained in chapter 5, there are several uncertainties in our cost
estimates.  For example, the states are likely to use different
approaches for reducing NOx and VOCs in their state implementation plans
to reach a tighter standard.  In addition, since we are unable to use
known controls to get all areas into attainment, we needed to use simple
$/ton costs to estimate the overall national cost of meeting the tighter
alternatives.

As discussed in chapter 5, recent advice from EPA’s Science Advisory
Board has questioned the appropriateness of an approach similar to that
used here for estimating extrapolated costs.  EPA will consider this
advice and other guidance as it develops the methodology for analyzing
the final rule.

Both extrapolated costs and benefits have additional uncertainty
relative to modeled costs and benefits.   The extrapolated costs and
benefits will only be realized to the extent that unknown extrapolated
controls are economically feasible and are implemented.

Technological advances over time will tend to increase the economic
feasibility of reducing emissions, and will tend to reduce the costs of
reducing emissions.

These sources of uncertainty are discussed in more detail in subsequent
chapters of the RIA. In addition to considering any advice which comes
from advisory bodies prior to the publication of the final ozone NAAQS,
EPA will undertake an updated approach with improvements to emissions
inventories, models and control strategies for the RIA which will
accompany that rulemaking.

 The California full attainment costs calculated using the offset in NOx
emissions from mobile programs would understate the costs of fully
attaining in 2020, however, California will not be required to attain in
2020.

 This approach would be an overestimate of national full attainment
costs in a future year after 2020 because it would not take into account
that other states (not just California) could replace more expensive NOx
reductions from other sources with the post-2020  reductions obtained
from implementation of mobile source rules that are included in the
regulatory baseline.

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