[Federal Register Volume 77, Number 209 (Monday, October 29, 2012)]
[Notices]
[Pages 65555-65560]
[FR Doc No: 2012-26472]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0547]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Survey on the
Occurrence of Foodborne Illness Risk Factors in Selected Retail and
Foodservice Facility Types (2013-2022)

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995 (the PRA).

DATES: Fax written comments on the collection of information by
November 28, 2012.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-NEW and
title ``Survey on the Occurrence of Foodborne Illness Risk Factors in
Selected Retail and Foodservice Facility Types (2013-2022).'' Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Information
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400B,
Rockville, MD 20850,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Survey on the Occurrence of Foodborne Illness Risk Factors in Selected
Retail and Foodservice Facility Types (2013-2022)--(OMB Control Number
0910-NEW)

I. Background

    In 1998, the U.S. Food and Drug Administration's National Retail
Food Team initiated a 10-year voluntary survey to measure trends in the
occurrence of foodborne illness risk factors--preparation practices and
employee behaviors most commonly reported to the Centers for Disease
Control and Prevention (CDC) as contributing factors to foodborne
illness outbreaks at the retail level. Specifically, the survey
included data collection inspections of various types of retail and
foodservice establishments at 5-year intervals (1998, 2003, and 2008)
in order to observe and document trends in the occurrence of the
following foodborne illness risk factors:
     Food from Unsafe Sources.
     Poor Personal Hygiene.
     Inadequate Cooking.
     Improper Holding/Time and Temperature.
     Contaminated Equipment/Protection from Contamination.
    FDA developed reports summarizing the findings for each of the
three data collection periods (1998, 2003, and 2008) (Refs. 1 to 3).
Data from all three data collection periods were analyzed to detect
trends in improvement or regression over time and to determine whether
progress had been made toward the goal of reducing the occurrence of
foodborne illness risk factors in selected retail and foodservice
facility types (Ref. 4).
    The research obtained from these studies provides FDA a solid
foundation for developing a national retail food program model that can
be used by Federal, State, local, and tribal agencies to:
     Identify essential food safety program performance
measurements;
     Assess strengths and gaps in the design, structure, and
delivery of program services;
     Establish program priorities and intervention strategies
focused on reducing the occurrence of foodborne illness risk factors;
and
     Create a mechanism that justifies program resources and
allocates them to program areas that will provide the most significant
public health benefits.
    Using this 10-year survey as a foundation, FDA is proposing to
conduct a new voluntary survey encompassing annual data collections
over a 10-year period. The survey will

determine the following for each facility type included in the study:
     The foodborne illness risk factors that are in most need
of priority attention during each data collection period;
     Trends of improvement or regression in foodborne illness
risk factor occurrence over time; and
     The impact of industry food safety management systems in
controlling the occurrence of foodborne illness risk factors.
    The results of the proposed study will be used to:
     Formulate Agency retail food safety policies and
initiatives;
     Identify retail food work plan priorities and allocate
resources to enhance retail food safety nationwide;
     Generate nationally representative estimates of the
progress being made to reduce the occurrence of foodborne illness risk
factors in retail and foodservice establishments; and
     Recommend best practices and targeted intervention
strategies to assist the retail and foodservice industry and state,
local, and tribal regulators with reducing foodborne illness risk
factors.
    The statutory basis for FDA conducting this survey is the Public
Health Service Act (the PHS Act) (42 U.S.C 243, section 311(a)) (Also
21 CFR 5.10(a)(2) and (4)), which requires that FDA provide assistance
to state and local governments relative to the prevention and
suppression of communicable diseases. In addition, the PHS Act requires
that FDA cooperate with and aid state and local authorities in the
enforcement of their health regulations and provide advice on matters
relating to the preservation and improvement of public health.
Additionally, the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301)
and Economy Act (31 U.S.C. 1535) require that FDA provide assistance to
other Federal, State, and local governmental bodies.
    In early 2013, FDA will conduct a pilot data collection to practice
the use of the data collection form and methods and test exportation of
the pilot data into a central repository. Following the pilot, the
Agency plans to conduct annual data collections beginning in 2013 with
the initial data collection for select restaurant facility types,
followed by the initial data collection for select institutional
foodservice facility types in 2014 and select retail food store
facility types in 2015. The results of the initial data collection for
each of the facility types will serve as the baseline measurement from
which trends will be analyzed. Two additional data collection periods
for each of the facility types are planned at 3-year intervals after
the initial data collection for purposes of analyzing trends.

                               Table 1--Summary of Data Collection Timeframes \1\
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                                                          Year for initial
                                      Facility types      data collection      Second data      Third and final
         Industry segment             included in the        (baseline      collection period   data collection
                                          survey            measurement)                             period
----------------------------------------------------------------------------------------------------------------
Restaurants......................  Full Service                       2013               2016               2019
                                    Restaurants.
                                   Fast Food
                                    Restaurants.
Institutional Foodservice........  Hospitals...........               2014               2017               2020
                                   Nursing Homes.......
                                   Elementary Schools
                                    (K-5).
Retail Food Stores...............  Deli Departments/                  2015               2018               2021
                                    Stores.
                                   Meat & Poultry
                                    Departments/Markets.
                                   Seafood Departments/
                                    Markets.
                                   Produce Departments/
                                    Markets.
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\1\ Data collections for each of the facility types within an industry segment will be conducted using a 3-year
  interval period. Initial data collection will serve as the baseline. Subsequent collections will provide the
  data needed to analyze trends.

    A description of the facility types included in the proposed survey
is included in table 2:

    Table 2--Description of the Facility Types Included in the Survey
------------------------------------------------------------------------
       Industry segment         Facility type          Description
------------------------------------------------------------------------
Restaurants..................  Full Service     Establishments where
                                Restaurants.     customers place their
                                                 order at their table,
                                                 are served their meal
                                                 at the table, receive
                                                 the service of the wait
                                                 staff, and pay at the
                                                 end of the meal.
                               Fast Food        Also referred to as
                                Restaurants.     quick service
                                                 restaurants and defined
                                                 as any restaurant that
                                                 is not a full service
                                                 restaurant.
Institutional Foodservice....  Hospitals......  Foodservice operations
                                                 that serve patients,
                                                 staff, and hospital
                                                 visitors in a
                                                 traditional hospital
                                                 setting. Individuals
                                                 who are acutely ill to
                                                 those who are
                                                 immunocompromised are a
                                                 target population for
                                                 data collection.
                               Nursing Homes..  Foodservice operations
                                                 that serve highly
                                                 susceptible populations
                                                 living in a group care
                                                 setting. The elderly
                                                 (55+ years) is the
                                                 target population for
                                                 the data collection.
                                                 Also includes assisted
                                                 living facilities.
                               Elementary       Foodservice operations
                                Schools (K-5).   that serve students
                                                 from one or more grade
                                                 levels from preschool
                                                 through grade 5. Young
                                                 children are a target
                                                 population for the data
                                                 collection.

Retail Food Stores...........  Deli             Departments in retail
                                Departments/     food stores where
                                Stores.          potentially hazardous
                                                 foods (time/temperature
                                                 control for safety
                                                 foods) such as luncheon
                                                 meats and cheeses are
                                                 sliced for the customer
                                                 and where sandwiches
                                                 and salads are prepared
                                                 on site or received
                                                 from a commissary in
                                                 bulk containers,
                                                 portioned, and
                                                 displayed. Freestanding
                                                 cheese shops are
                                                 categorized as delis.
                                                 Parts of the deli may
                                                 also include:
                                                    Salad bars
                                                    and other food bars
                                                    maintained by the
                                                    deli department
                                                    manager;
                                                    Areas where
                                                    meat or poultry are
                                                    cooked and offered
                                                    for sale as ready-to-
                                                    eat;
                                                    Pizza
                                                    stands; and
                                                    Limited
                                                    bakery operations
                                                    attached to or
                                                    adjacent to the
                                                    deli.
                               Meat and         Meat and poultry
                                Poultry          departments in a retail
                                Departments/     food store, as well as
                                Markets.         any freestanding meat
                                                 market or butcher shop
                                                 that sells raw meat or
                                                 poultry directly to the
                                                 consumer.
                               Seafood          Seafood departments in
                                Departments/     retail food stores and
                                Markets.         freestanding seafood
                                                 markets that sell
                                                 seafood directly to the
                                                 consumer including the
                                                 preparation and sale of
                                                 raw and/or ready-to-eat
                                                 seafood. In-store sushi
                                                 bars are considered
                                                 part of the seafood
                                                 department for the
                                                 purposes of the data
                                                 collection.
                               Produce          Areas or departments
                                Departments/     where produce is cut,
                                Markets.         prepared, stored, or
                                                 displayed. A produce
                                                 department may include
                                                 salad bars that are
                                                 managed by the produce
                                                 manager, as well as
                                                 juicers.
------------------------------------------------------------------------

    A geographical information system database containing a listing of
businesses throughout the United States will be used as the
establishment inventory for the data collections. FDA's Center for Food
Safety and Applied Nutrition (CFSAN) Biostatistical Branch, in
collaboration with the FDA National Retail Food Team, will perform a
series of filtering processes of the various database food
establishment categories to ensure establishments are correctly
classified and considered eligible to participate in the survey based
on the descriptions in table 2.
    To further determine the pool of establishments eligible for
selection, an effort will be made to exclude operations that handle
only prepackaged food items or conduct low-risk food preparation
activities. The FDA Food Code contains a grouping of establishments by
risk, based on the type of food preparation that is normally conducted
within the operation (Ref. 5). The vast majority of selected
establishments are to be chosen from risk categories 2 through 4.
    FDA has approximately 25 Regional Retail Food Specialists
(Specialists) who will serve as the data collectors for the 10-year
study. The Specialists are geographically dispersed throughout the
United States and possess technical expertise in retail food safety and
a solid understanding of the operations within each of the facility
types to be surveyed. The Specialists are also standardized by FDA's
CFSAN personnel in the application and interpretation of the FDA Food
Code (Ref. 5). The geographical distribution of Specialists throughout
the United States allows for a broad sampling of facility types in all
regions of the United States; therefore, establishments will be
randomly selected to participate in the study from among all eligible
establishments located within a 150-mile radius of each of the
Specialists' home locations.
    The pilot will include approximately 4 data collection inspections
for each of the approximately 25 Specialists, or a total of 100
inspections. In order to obtain a sufficient number of observations to
conduct statistically significant analysis, the FDA CFSAN
Biostatistical Branch has determined, based on the previous 10-year
foodborne illness risk factor study that was performed, that
approximately 400 data collection inspections of each facility type are
needed during the initial and subsequent data collection periods. The
sample for each data collection period will be evenly distributed among
Specialists. Given that participation in the study by industry is
voluntary and the status of any given randomly selected establishment
is subject to change, substitute establishments will be selected for
each Specialist for cases in which the restaurant facility is
misclassified, closed, or otherwise unavailable, unable, or unwilling
to participate.
    Prior to conducting the data collection, Specialists will contact
the state or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment. The
Specialist will verify with the jurisdiction that the facility has been
properly classified for the purposes of the study and is still in
operation. The Specialist will also ascertain whether the selected
facility is under legal notice from the state or local regulatory
authority. If the selected facility is under legal notice, the
Specialist will not conduct a data collection and a substitute
establishment will be used. An invitation will be extended to the state
or local regulatory authority to accompany the Specialist on the data
collection visit.
    A standard data collection form will be used by the Specialists
during each inspection. The form is divided into three sections:
Section 1--Establishment Information; Section 2--Regulatory Authority
Information; and Section 3--Foodborne Illness Risk Factor and Food
Safety Management System Assessment. Section 3 includes three parts
(parts A-C) for tabulating the Specialists' observations of the food
employees' behaviors and practices in limiting contamination,
proliferation, and survival of food safety hazards (part A); the
industry food safety management being implemented by the facility (part
B); and the frequency of food employee hand washing (part C).
    In completing Section 1--Establishment Information of the form,
Specialists will ask a standardized set of questions to the
establishment owner or person in charge. In completing Section 2--
Regulatory Authority Information, the Specialist will ask a
standardized set of questions to the program director (or

other designed personnel) of the state or local jurisdiction that has
regulatory responsibility for conducting inspections for the selected
establishment. The information for completing Section 3, part A of the
form will be collected from the Specialists' direct observations of
food employee behaviors and practices, supplemented by infrequent,
nonstandardized questions to industry personnel when clarification is
needed of the food safety procedure or practice being observed. For
Section 3, part B of the form, Specialists will ask industry management
a standardized set of questions to obtain information on the extent to
which the food establishments have developed and implemented food
safety management systems. Section 3, part C of the form will involve
only direct observations of hand washing frequency by the Specialists.
No questions will be asked in the completion of this part of the form.
    In the Federal Register of June 19, 2012 (77 FR 36544), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. There were five comments received:
    (Comment 1) Jane Public commented that she does not see the
usefulness of the study. She also commented that most foodborne illness
resulting from food from unsafe sources was caused by agribusiness. She
commented that having a Web site on which the public or doctors
treating the sick and deceased can post information about foodborne
illness would be more effective and targeted than the data collection
being proposed by FDA.
    (Response) FDA believes that many of the comments made by this
submitter are unrelated to the proposed data collection. Relative to
the suggestion to have a Web site on which the public or doctors
treating the sick or deceased can post information about foodborne
illness, surveillance systems like this are already used in the United
States to provide information about the occurrence of foodborne disease
including, but not limited to, the following: Foodborne Disease Active
Surveillance Network (FoodNet); National Antimicrobial Resistance
Monitoring System--enteric bacteria (NARMS); National Electronic
Norovirus Outbreak Network (CaliciNet); National Molecular Subtyping
Network for Foodborne Disease Surveillance (PulseNet); National
Notifiable Diseases Surveillance System (NNDSS); National Outbreak
Reporting System (NORS); Environmental Health Specialists Network (EHS-
Net); and the Public Health Laboratory Information System (PHLIS).
While each surveillance system plays an important role in detecting and
preventing foodborne disease and outbreaks, surveillance statistics
reflect only a fraction of the cases that occur in the community. This
is because foodborne illnesses are largely underdiagnosed and
underreported. In addition, surveillance statistics are, by nature,
reactive, meaning information is obtained on foodborne illness that has
already occurred. In contrast, the data collection proposed by FDA is
proactive in nature because it seeks to collect data on the behaviors
and practices that could lead to foodborne illness or deaths if not
controlled. Using this data, FDA will formulate and implement
intervention strategies to proactively reduce foodborne illness risk
factors that lead to illness or death if not controlled. For these
reasons, FDA does not agree with the submitter that another
surveillance-type reporting system would be more effective or targeted
than the data collection being proposed by FDA.
    (Comment 2) The Food Marketing Institute (FMI) commented that FDA
appears to have underestimated the amount of time needed at 15 minutes
per event. The commenter states that based on the retail industry's
experience during the last survey (2008), the time spent collecting and
monitoring data points took up 120 minutes per event per retail grocer,
and this caused an undue interruption to business operations and passed
on unnecessary costs to those surveyed.
    (Response) OMB's regulations at 5 CFR 1320.3(h) define the term
``information.'' Numbered paragraphs under (h) list categories of data
that are not ``information,'' and thus do not require OMB approval
under the PRA. Under paragraph (h)(3), ``[f]acts or opinions obtained
through direct observation by an employee or agent of the sponsoring
agency or through nonstandardized oral communication in connection with
such direct observations,'' is not ``information collection'' subject
to OMB approval under the PRA. Thus, the estimate of burden is not
required to account for the duration of the entire inspection since the
data collector's questions will largely be nonstandardized, oral
communication in connection with his or her direct observations.
    In contrast, information collected in Sections 1 and 2 and Section
3, part B of the data collection form is not available to the data
collectors by direct observation together with nonstandardized, oral
communication and can only be obtained by asking the establishment's
representatives to respond to a set of standardized questions. Thus,
the burden is accurately calculated based solely on the time it will
take for the data collectors to interview the respondents to complete
these specific sections of the form. However, in consideration of FMI's
comment and recent data collection training that was conducted with
FDA's National Retail Food Team in September 2012, FDA believes that
the original burden for the respondents that was published in table 1
of the 60-day notice may have been underestimated. For this reason, FDA
is increasing the burden estimate for each respondent to 30 minutes per
response.
    (Comment 3) FMI commented that FDA is not aligned with CDC in the
development of the study. According to CDC data, most foodborne illness
outbreaks occur in restaurants (39 percent compared to <1 percent
foodborne illness events occurring in grocery stores as well as 21
percent compared to <1 percent actual foodborne illnesses occurring in
grocery stores). Based on the data, FMI believes the study seems to put
an unnecessary burden on retail grocery stores as retail grocery stores
will be surveyed at a 4:1 ratio. The study should be more balanced
between the restaurants and grocers.
    (Response) FDA has kept and will continue to keep key CDC staff
informed of the plans for and results of the Risk Factor Study so that
areas in which our concurrent studies reinforce or run counter to one
another can be analyzed and appropriate prevention-based messages
developed.
    The proposed sample size for each facility type is not intended to
mirror the respective burden of foodborne illness caused by each type,
but rather represents the minimum number of inspections needed to
obtain the number of observations needed to draw statistically
significant conclusions. If FDA reduced the number of establishments
inspected for the retail food store facility types, it is likely FDA
would not obtain the number of observations needed to draw
statistically valid conclusions or have the desired confidence level in
the data that is obtained.
    The restaurant industry segment includes two facility types,
institutional foodservice includes three facility types, and the retail
food store industry segment includes four facility types. While the
total number of data collection inspections in retail food store
segment will be higher than that for the restaurant segment, the number

of data collection inspections for each facility type will be the same.
    (Comment 4) FMI believes the proposed study fails to meet FDA's
Information Quality Guidelines and the requirements of the Data Quality
Act because its structure will not provide information of utility to
the public or the Agency as it is disproportionately focused on retail
food stores when statistics indicate that far more foodborne illness
events occur in restaurants.
    (Response) Information dissemination is an important part of FDA's
mission to promote and protect the public health. FDA recognizes that
public access to high quality information is critical to achieving this
mission and public input, in turn, improves the quality of the
information we disseminate. Because of the nature of this information,
our goal has been and remains to ensure that all the information we
disseminate meets the high standards of quality (including objectivity,
utility, and integrity) described in the OMB and HHS Guidelines and the
Data Quality Act (DQA).
    To that end, FDA does not agree with FMI's comment that the
proposed information collection fails to meet FDA's Information Quality
Guidelines and the requirements of the DQA. The sample size in the
proposed information collection is not intended to mirror the
respective burden of foodborne illness caused by each facility type.
Rather, it represents the minimum number of inspections needed for each
facility type in order to obtain a sufficient number of observations to
draw statistically significant conclusions. If FDA were to reduce the
sample size of the retail food store facility types to be more
reflective of the burden of foodborne illness caused by these entities,
the quality of the data would be compromised and its utility would be
severely limited. This is because it would be unlikely that FDA could
obtain the number of observations needed to draw statistically valid
conclusions or have the desired confidence level in the conclusions we
are able to make.
    (Comment 5) The American Meat Institute Foundation (AMIF) commented
that they support FDA's proposed survey of selected retail and
foodservice facility types. According to AMIF, the survey findings will
have practical utility by enhancing the knowledge of foodborne illness
risk factors in these types of facilities, informing decisions for
developing and implementing risk mitigation strategies, and guiding
food safety resource allocation. The followup data collection periods
will be useful tools to track trends and benchmark improvements in
reducing risk factors.
    (Response) FDA thanks the AMIF for their comments and appreciates
their support in this undertaking.
    Regarding the burden estimation, due to the infrequent and
nonstandard nature of the questions that may or may not be asked to
clarify direct observations made by the Specialists in completing
Section 3, parts A and C of the data collection form, only the burden
associated with the information collection related to the completion of
Sections 1 and 2 and Section 3, part B of the form is included in
burden estimates. For each data collection, the respondents will
include the person in charge of the selected facility and the program
director (or designated individual) of the respective regulatory
authority. In consideration of FMI's comment to the 60-day notice and
recent data collection training that was conducted with FDA's National
Retail Food Team in September 2012, FDA believes that the original
burden that was published in table 3 of the 60-day notice may have been
underestimated. For this reason, FDA is increasing the burden estimate
for each respondent by 15 minutes per response. For the pilot, 25
Specialists will conduct 4 data collection inspections; thus, FDA
estimates the number of respondents to be 200 (25 Specialists x 4 data
collection inspections x 2 respondents per data collection). The
estimate of the hours per response is based on its previous experience
with collecting similar information in previous data collection
efforts. We estimate that it will take each of the respondents 30
minutes (0.5 hours) to answer the questions related to Sections 1 and 2
and Section 3, part B of the form, for a total of 100 hours. FDA bases
its estimate of the number of respondents during the subsequent
activities (data collections) on 400 inspections being conducted in
each facility type. FDA CFSAN's Biostatistical Branch has determined
that 400 inspections are necessary to provide the sufficient number of
observations needed to conduct a statistically significant analysis of
the data. The data collections in the Restaurant Segment will occur in
2013, 2016, and 2019 and will each consist of 1,600 respondents. We
estimate that it will take each respondent 30 minutes (0.5 hours) to
answer the questions related to Sections 1 and 2 and Section 3, part B
of the form, for a total of 800 hours. The data collections in the
Institutional Foodservice Segment will occur in 2014, 2017, and 2020
and will each consist of 2,400 respondents. We estimate that it will
take each respondent 30 minutes (0.5 hours) to answer the questions
related to Sections 1 and 2 and Section 3, part B of the form, for a
total of 1,200 hours. The data collections in the Retail Food Store
Segment will occur in 2015, 2018, and 2021 and will each consist of
3,200 respondents. We estimate that it will take a respondent 30
minutes (0.5 hours) to answer the questions related to Sections 1 and 2
and Section 3, part B of the form, for a total of 1,600 hours. Thus,
the total estimated burden is 10,900 hours.

                                 Table 3--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
            Activity                 Number of     responses per   Total annual    Average burden    Total hours
                                    respondents     respondent       responses      per response
----------------------------------------------------------------------------------------------------------------
Pilot Data Collection to                     200               1             200               0.5           100
 Practice Use of Form and
 Methods and Exportation of Data
 into Central Repository........
2013 Baseline Data Collection--            1,600               1           1,600           \2\ 0.5           800
 Restaurant Segment (includes
 two facility types)............
2014 Baseline Data Collection--            2,400               1           2,400           \2\ 0.5         1,200
 Institutional Foodservice
 Segment (includes three
 facility types)................
2015 Baseline Data Collection--            3,200               1           3,200           \2\ 0.5         1,600
 Retail Food Store Segment
 (includes four facility types).
2016 Second Data Collection--              1,600               1           1,600           \2\ 0.5           800
 Restaurant Segment (includes
 two facility types)............
2017 Second Data Collection--              2,400               1           2,400           \2\ 0.5         1,200
 Institutional Foodservice
 Segment (includes three
 facility types)................

2018 Second Data Collection--              3,200               1           3,200           \2\ 0.5         1,600
 Retail Food Store Segment
 (includes four facility types).
2019 Third and Final Data                  1,600               1           1,600           \2\ 0.5           800
 Collection--Restaurant Segment
 (includes two facility types)..
2020 Third and Final Data                  2,400               1           2,400           \2\ 0.5         1,200
 Collection--Institutional
 Foodservice Segment (includes
 three facility types)..........
2021 Third and Final Data                  3,200               1           3,200           \2\ 0.5         1,600
 Collection--Retail Food Store
 Segment (includes four facility
 types).........................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ................       10,900
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.
\2\ 30 minutes.

II. References

    The following references have been placed on display in the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site addresses, but we are not responsible for any
subsequent changes to the Web sites after this document publishes in
the Federal Register.)
    1. Report of the FDA Retail Food Program Steering Committee,
``Database of Foodborne Illness Risk Factors (2000).'' Available at:
http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/FoodCode2001/ucm123544.htm.
    2. ``FDA Report on the Occurrence of Foodborne Illness Risk
Factors in Selected Institutional Foodservice, Restaurant, and
Retail Food Store Facility Types (2004).'' Available at: http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorstudies/ucm089696.htm.
    3. ``FDA Report on the Occurrence of Foodborne Illness Risk
Factors in Selected Institutional Foodservice, Restaurant, and
Retail Food Store Facility Types (2009).'' Available at: http://www.fda.gov/downloads/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/RetailFoodRiskFactorStudies/ucm224682.pdf.
    4. FDA National Retail Food Team, ``FDA Trend Analysis Report on
the Occurrence of Foodborne Illness Risk Factors in Selected
Institutional Foodservice, Restaurant, and Retail Food Store
Facility Types (1998-2008).'' Available at: http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodborneIllnessandRiskFactorReduction/RetailFoodRiskFactorStudies/ucm223293.htm.
    5. ``FDA Food Code.'' Available at: http://www.fda.gov/Food/FoodSafety/RetailFoodProtection/FoodCode/default.htm.

    Dated: October 23, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-26472 Filed 10-26-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: May 15, 2008 (Volume 73, Number 95)]
[Notices]
[Page 28183]
[DOCID:fr15my08-104]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Intent To Request Revision From the Office of
Management and Budget of a Currently Approved Information Collection
Activity, Request for Comments; Application for Certificate of Waiver
or Authorization

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: The FAA invites public comments about our intention to request
the Office of Management and Budget (OMB) to approve a current
information collection. Respondents conducting general operation and
flight of aircraft or any activity that could encroach on airspace must
apply for approval.

DATES: Please submit comments by July 14, 2008.

FOR FURTHER INFORMATION CONTACT: Carla Mauney on<PHONE_NUMBER>, or by
e-mail at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Federal Aviation Administration (FAA)

    Title: Application for Certificate of Waiver or Authorization.
    Type of Request: Extension without change of an approved
collection.
    OMB Control Number: 2 120-0027.
    Forms(s): 7711-2.
    Affected Public: A total of 25,231 respondents.
    Frequency: The information is collected on occasion.
    Estimated Average Burden Per Response: Approximately 32 minutes per
response.
    Estimated Annual Burden Hours: An estimated 13,646 hours annually.
    Abstract: U.S. Code authorizes the issuance of regulations
governing the use of navigable airspace. Respondents conducting general
operation and flight of aircraft or any activity that could encroach on
airspace must apply for approval.

ADDRESSES: Send comments to the FAA at the following address: Ms. Carla
Mauney, Room 712, Federal Aviation Administration, IT Enterprises
Business Services Division, AES-200, 800 Independence Ave., SW.,
Washington, DC 20591.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimates of the burden of
the proposed information collection; ways to enhance the quality,
utility and clarity of the information to be collected; and ways to
minimize the burden of the collection of information on respondents,
including the use of automated collection techniques or other forms of
information technology.

Issued in Washington, DC, on May 6, 2008.
Carla Mauney,
FAA Information Collection Clearance Officer, IT Enterprises Business
Services Division, AES-200.
 [FR Doc. E8-10571 Filed 5-14-08; 8:45 am]

BILLING CODE 4910-13-M


[Federal Register: October 7, 2008 (Volume 73, Number 195)]
[Notices]
[Page 58698]
[DOCID:fr07oc08-124]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 58711]

Order Extending Emergency Order Pursuant to Section 12(k)(2) of
the Securities Exchange Act of 1934 Taking Temporary Action To Respond
to Market Developments

October 1, 2008.
    Pursuant to Section 12(k)(2) of the Securities Exchange Act of 1934
(``Exchange Act''),\1\ on September 17, 2008, the Securities and
Exchange Commission (``Commission'') issued an Emergency Order (the
``Order'') aimed at further reducing fails to deliver and addressing
potentially abusive ``naked'' short selling in all equity
securities.\2\ The Order became effective at 12:01 a.m. E.D.T. on
September 18, 2008 and is currently set to terminate at 11:59 p.m.
E.D.T. on October 1, 2008.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78l(k)(2).
    \2\ See Securities Exchange Act Release No. 58572 (Sept. 17,
2008).
---------------------------------------------------------------------------

    Pursuant to our authority under Section 12(k)(2)(C) of the Exchange
Act, we are extending the Order. Section 12(k)(2)(C) authorizes the
Commission to extend an emergency order issued pursuant to Section
12(k)(2)(A) of the Exchange Act for a total effective period of up to
30 calendar days, if the Commission finds that the emergency still
exists and determines that an extension is necessary in the public
interest and for the protection of investors to maintain fair and
orderly securities markets.
    We have carefully reevaluated the current state of the markets and
we remain concerned about the potential of sudden and excessive
fluctuations of securities prices generally and disruption in the
functioning of the securities markets that could threaten fair and
orderly markets. We intend the enhanced delivery requirements
(temporary Rule 204T and elimination of the options market maker
exception) imposed by the Order and the ``naked'' short selling
antifraud rule to provide powerful disincentives to those who might
otherwise exacerbate artificial price movements through ``naked'' short
selling. Thus, we have determined in this environment that the
standards under Section 12(k)(2) for extending the Order have been met.
Accordingly, we have determined that extending the Order is in the
public interest and necessary to maintain fair and orderly securities
markets and for the protection of investors.
    In addition, we note that Staff of the Division of Trading and
Markets has issued guidance regarding the Order to address current and
anticipated technical and operational concerns resulting from the
requirements of the Order.\3\ The guidance will continue to apply for
the duration of the Order and the Commission hereby incorporates and
adopts the guidance.
---------------------------------------------------------------------------

    \3\ See http://www.sec.gov/divisions/marketreg/204tfaq.htm and
http://www.sec.gov/divisions/marketreg/loanedsecuritiesfaq.htm.
---------------------------------------------------------------------------

    It is therefore ordered that, pursuant to Section 12(k)(2)(C) of
the Exchange Act, the Commission hereby incorporates and adopts the
Division of Trading and Markets: Guidance Regarding the Commission's
Emergency Order Concerning Rules to Protect Investors Against ``Naked''
Short Selling Abuses and the Division of Trading and Markets Guidance
Regarding Sale of Loaned but Recalled Securities.
    It is further ordered that, pursuant to Section 12(k)(2)(C) of the
Exchange Act, the Order is extended such that it will terminate at
11:59 p.m. E.D.T. on Friday, October 17, 2008.

    By the Commission.
Florence E. Harmon,
Acting Secretary.
 [FR Doc. E8-23614 Filed 10-6-08; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 67 (Wednesday, April 8, 2015)]
[Notices]
[Pages 18894-18896]
[FR Doc No: 2015-07961]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-74633; File No. SR-MIAX-2015-25]

Self-Regulatory Organizations; Miami International Securities
Exchange LLC; Notice of Filing and Immediate Effectiveness of a
Proposed Rule Change To Amend Its Fee Schedule

April 2, 2015.
    Pursuant to the provisions of 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 March 31, 2015, Miami International Securities
Exchange LLC (``MIAX'' or ``Exchange'') filed with the Securities and
Exchange Commission (``Commission'') a proposed rule change as
described in Items I, II, and III below, which Items have been prepared
by the Exchange. 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.
---------------------------------------------------------------------------

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

    The Exchange is filing a proposal to amend the MIAX Options Fee
Schedule (the ``Fee Schedule'').
    The text of the proposed rule change is available on the Exchange's
Web site at http://www.miaxoptions.com/filter/wotitle/rule_filing, at
MIAX's principal office, 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 the MIAX Options Fee Schedule (the
``Fee Schedule'') to increase the fees for MEI Ports to Market Makers.
Specifically, the Exchange proposes to: (i) Increase the MEI Port Fee
for the first matching engine used, from $1,000 to $2,500 per month;
(ii) increase the MEI Port Fee for each of matching engines 2 through
5, from $500 to $1,200 per month; (iii) increase the MEI Port Fee for
each of matching engines 6 and above, from $250 to $700 per month; and
(iv) increase the fee for additional Limited Service MEI Ports from $10
to $50 per month.
    Currently, MIAX assesses monthly MEI Port Fees on Market Makers
based upon the number of MIAX matching engines \3\ used by the Market
Maker. MEI Port users are allocated two Full Service MEI Ports \4\ and
two Limited Service MEI Ports \5\ per matching engine to which they
connect. The Exchange currently assesses a fee of $1,000 per month on
Market Makers for the first matching engine they use; $500 per month
for each of matching engines 2 through 5; and $250 per month for each
of matching engines 6 and above. For

example, a Market Maker that wishes to make markets in just one symbol
would require the two MEI Ports in a single matching engine; a Market
Maker wishing to make markets in all symbols traded on MIAX would
require the two MEI Ports in each of the Exchange's matching engines.
The Exchange also currently charges $10 per month for each additional
Limited Service MEI Port per matching engine for Market Makers in
addition to the two Limited Service MEI Ports per matching engine that
are allocated with the Full Service MEI Ports. The Full Service MEI
Ports, Limited Service MEI Ports and the additional Limited Service MEI
Ports all include access to MIAX's primary and secondary data centers
and its disaster recovery center.
---------------------------------------------------------------------------

    \3\ A ``matching engine'' is a part of the MIAX electronic
system that processes options quotes and trades on a symbol-by-
symbol basis. Some matching engines will process option classes with
multiple root symbols, and other matching engines will be dedicated
to one single option root symbol (for example, options on SPY will
be processed by one single matching engine that is dedicated only to
SPY). A particular root symbol may only be assigned to a single
designated matching engine. A particular root symbol may not be
assigned to multiple matching engines.
    \4\ Full Service MEI Ports provide Market Makers with the
ability to send Market Maker quotes, eQuotes, and quote purge
messages to the MIAX System. Full Service MEI Ports are also capable
of receiving administrative information. Market Makers are limited
to two Full Service MEI Ports per matching engine.
    \5\ Limited Service MEI Ports provide Market Makers with the
ability to send eQuotes and quote purge messages only, but not
Market Maker Quotes, to the MIAX System. Limited Service MEI Ports
are also capable of receiving administrative information. Market
Makers initially receive two Limited Service MEI Ports per matching
engine.
---------------------------------------------------------------------------

    The Exchange notes that another competing exchange charges
substantially more for the use of similar ports.\6\ The Exchange
established the current lower rates in order to encourage additional
market participants to become Members of the Exchange and register as
Market Makers and use the service. Now that the Exchange has grown its
market share and membership base, the Exchange proposes to modify its
fees charged to Market Makers for use of MEI Ports in an effort to
increase the Exchange's revenues from non-transaction fee sources and
also more closely align the fees with the rates charged by another
competing options exchange. Accordingly, the Exchange proposes to
increase the fees charged to Market Makers for use of MEI Ports.
Specifically, the Exchange proposes to: (i) Increase the MEI Port Fee
for the first matching engine used, from $1,000 to $2,500 per month;
(ii) increase the MEI Port Fee for each of matching engines 2 through
5, from $500 to $1,200 per month; (iii) increase the MEI Port Fee for
each of matching engines 6 and above, from $250 to $700 per month; and
(iv) increase the fee for additional Limited Service MEI Ports from $10
to $50 per month.
---------------------------------------------------------------------------

    \6\ See NASDAQ OMX PHLX LLC (``PHLX'') Pricing Schedule, Section
VII. PHLX assesses specialists and market makers Active SQF Port Fee
of $2,500 per month for the first port, $4,000 per month for ports
2-6, and $15,000 per month for ports 7 and over. Active SQF Port
Fees are capped at $42,000 per month.
---------------------------------------------------------------------------

    The Exchange proposes to implement the fee changes beginning April
1, 2015.
2. Statutory Basis
    The Exchange believes that its proposal to amend its fee schedule
is consistent with Section 6(b) of the Act \7\ in general, and furthers
the objectives of Section 6(b)(4) of the Act \8\ in particular, in that
it is an equitable allocation of reasonable fees and other charges.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78f(b).
    \8\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that the proposal is reasonable and not
unfairly discriminatory because Market Makers are free to add and
remove MEI Ports and will only be charged for the amount of MEI Ports
that they desire to use. The proposed fee is fair and equitable and not
unreasonably discriminatory because it applies equally to all Market
Makers regardless of type. All similarly situated Market Makers, with
the same number of MEI Ports, will be subject to the same fee, and
access to the Exchange is offered on terms that are not unfairly
discriminatory. The Exchange believes that the proposed fees are
reasonable in that the rates are within the range of that charged by
another competing options exchange.

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

    The Exchange does not believe that the proposed rule change will
result in any burden on competition that is not necessary or
appropriate in furtherance of the purposes of the Act, as amended. The
Exchange believes that the proposal increases both intermarket and
intramarket competition by increasing MEI Port fees for Market Makers
on the Exchange in the range of comparable fees on another exchange.
The Exchange notes that it operates in a highly competitive market in
which market participants can readily favor competing venues if they
deem fee levels at a particular venue to be excessive. In such an
environment, the Exchange must continually adjust its fees to remain
competitive with other exchanges and in order to attract market
participants to use its services. The Exchange believes that the
proposal reflects this competitive environment because it increases the
Exchange's fees in a manner that continues to encourage market
participants to register as Market Makers on the Exchange, to provide
liquidity, and to attract order flow. To the extent that this purpose
is achieved, all the Exchange's market participants should benefit from
the improved market liquidity.

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

    Written comments were neither solicited nor received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\9\ At any time within 60 days of the filing
of the 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. If the Commission takes such action, the Commission shall
institute proceedings to determine whether the proposed rule should be
approved or disapproved.
---------------------------------------------------------------------------

    \9\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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 email to<EMAIL_ADDRESS>Please include
File Number SR-MIAX-2015-25 on the subject line.

Paper Comments

     Send paper comments in triplicate to Brent J. Fields,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-MIAX-2015-25. This file
number should be included on the subject line if email 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
10:00 a.m. and 3:00 p.m. Copies of such filing also will be available
for inspection and copying at the principal office of the Exchange. 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 Number SR-MIAX-2015-25, and should be
submitted on or before April 29, 2015.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\10\
---------------------------------------------------------------------------

    \10\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Brent J. Fields,
Secretary.
[FR Doc. 2015-07961 Filed 4-7-15; 8:45 am]
 BILLING CODE 8011-01-P


EPA BIOPESTICIDES AND POLLUTION PREVENTION DIVISION COMPANY NOTICE OF
FILING FOR PESTICIDE PETITIONS PUBLISHED IN THE FEDERAL REGISTER

EPA Biopesticides and Pollution Prevention Division contact: [Linda
Hollis<PHONE_NUMBER>]

INSTRUCTIONS:  Please utilize this outline in preparing the pesticide
petition.  In cases where the outline element does not apply, please
insert “NA-Remove” and maintain the outline. Please do not change
the margins, font, or format in your pesticide petition. Simply replace
the instructions that appear in green, i.e., “[insert company
name],” with the information specific to your action.

SUBMISSION: E-mail the completed template to<EMAIL_ADDRESS>
TEMPLATE:

[Verdesian Life Sciences, LLC]

[Insert petition number]

	EPA has received a pesticide petition ([insert petition number]) from
[Verdesian Life Sciences, LLC], [1001 Winstead Drive, Suite 480, Cary,
NC 27513] proposing, pursuant to section 408(d) of the Federal Food,
Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a(d), to amend 40 CFR part
180.

(Options (pick one)

	1. by establishing a tolerance for residues of [NA-Remove]

	2. to establish an exemption from the requirement of a tolerance for
[NA- Remove]

	3. to establish an amendment/expansion of an existing tolerance
exemption for the

(Options (pick one)

	1. microbial pesticide  [NA-Remove]

	2. biochemical pesticide [phosphorous acid and its ammonium, sodium,
calcium, and potassium salts.]

	3. plant-pesticide [NA-Remove] in or on [NA-Remove].

	Pursuant to section 408(d)(2)(A)(i) of  FFDCA, as amended, [Verdesian
Life Sciences, LLC] has submitted the following summary of information,
data, and arguments in support of their pesticide petition. This summary
was prepared by [Verdesian Life Sciences, LLC] and EPA has not fully
evaluated the merits of the pesticide petition. The summary may have
been edited by EPA if the terminology used was unclear, the summary
contained extraneous material, or the summary unintentionally made the
reader conclude that the findings reflected EPA’s position and not the
position of the petitioner.

I. [Verdesian Life Sciences, LLC]  Petition Summary

	[Insert petition number]

A. Product Name and Proposed Use Practices

	[Calciphite is proposed as a pre- and post-harvest treatment on all
food commodities when used in accordance with good agricultural
practices and in or on potatoes when applied as a post-harvest treatment
at 35,600 ppm or less phosphorous acid.]

B. Product Identity/Chemistry

	1. Identity of the pesticide and corresponding residues. [Phosphorous
acid and its ammonium, sodium, and potassium salts are active
ingredients in numerous pesticide products registered by EPA as a pre-
and post-harvest agricultural fungicide.  These products as well as the
calcium salt of phosphorous acids are also used as fertilizer compounds
in significant quantities in the U.S.]

	2. Magnitude of residues at the time of harvest and method used to
determine the residue. [Phosphorous acid is a naturally-occurring
compound, commonly found as a salt.  Phosphorous is a required substance
in the metabolism of all living organisms. It is an integral building
block of both ribonucleic (RNA) and deoxyribonucleic acids (DNA).
Phosphates also play a critical role in energy transfer in metabolic
pathways.  The fact that phosphate plays a key role in the metabolism of
all living cells, it completely dissociates in water, and its low acute
toxicity are among the reasons why EPA does not regulate residues of
phosphorous acid arising from the pre- and post-harvest application of
fungicides containing salts of phosphorous acid as active ingredients.
Therefore, no magnitude of residue data, nor is an analytical method for
the determination of residues required.]

	3. A statement of why an analytical method of detecting and measuring
the levels of the pesticide residue are not needed. [Phosphorous acid is
currently exempt from tolerance; therefore, an analytical method is not
required by EPA.]

C. Mammalian Toxicological Profile

	[The toxicity profile for phosphorous acid and its ammonium, potassium,
and sodium salts has already been assessed for its pesticidal use by the
Agency and published in support of the tolerance exemption for residues
for pre- and post-harvest application of phosphorous acid in or on all
food commodities when used as an agricultural fungicide.

EPA has recognized the chemical and biological equivalence of calcium,
sodium and potassium phosphorous acid salts, which is based on classical
inorganic chemistry.  Both the alkali (potassium and sodium) and
alkaline (calcium) earth metal salts are fully ionized in aqueous
solution to both their cationic and anionic components.  The only
difference between calcium and potassium is the valence of the cation.

Potassium and calcium salts derived from acids (e.g., sulfates,
phosphates, phosphites, hydrochlorides, carbonates, etc.) are widespread
in nature as mineral constituents of soil and rocks.  Both calcium and
potassium are non-toxic and are essential for the well-being of human
metabolism and homeostasis.  Additionally, in support of the biological
equivalence of mono- and di-potassium and calcium phosphite salts, it
should be taken into account that minute residues of these salts, if
ingested, would generate, due to the hydrochloric acid in the highly
acidic human stomach, minute quantities of phosphorous acid and
potassium and calcium chlorite salts.  In minute quantities, neither
potassium chloride nor calcium chloride, would be expected to be toxic
since both are categorized as EPA Class III toxicity.

Thus based on the comparable biological equivalence of the fully ionized
mono- and di-potassium and calcium phosphite salts, it follows that the
toxicology and properties of mono- and di-potassium salts can be bridged
to the calcium salts.

For the purposes of this tolerance exemption amendment, Verdesian Life
Sciences, LLC is relying upon data and/or information previously
submitted to EPA, and also on the EPA reassessments recently completed
to add post-harvest uses.  Additionally, Verdesian Life Sciences, LLC is
also relying upon any publicly available data and information that EPA
used on phosphoric acid, which is chemically and structurally similar to
phosphorous acid.  The Agency stated that it believes that in
combination, the data and other information relied upon for the existing
tolerance exemption, supports its conclusion that there is reasonable
certainty of no harm that will result from the pre- and post-harvest
uses of phosphorous acid when used according to the recommended
application rate.  Additionally, based on Federal Register comments from
EPA, there is further support that there is reasonable certainty of no
harm that will result from the post-harvest treatment with a phosphorous
acid calcium salt end-use product.

In the original tolerance exemption publication, the Agency also pointed
to the fact that human toxicity from consumption of crops treated with
phosphorous acid fertilizers would be well known, if it occurred.  The
lack of reported dietary toxicity from consumption of crops treated with
phosphorous acid fertilizers is supporting evidence that use of
phosphorous acid applications as a fungicide should not result in
dietary toxicity.  EPA does not require residue chemistry data in cases
where the toxicity is so low and the use pattern will result in
exposures much lower than the highest dose tested without an effect.

Acute toxicity. Verdesian Life Sciences, LLC is relying upon acute
toxicity studies that were conducted with a 99% solution (Fungi-Phite DF
MUP, EPA Reg. No. 73771-6).  The toxicological profile of Fungi Phite DF
is briefly summarized as follows:

Acute oral (rat) toxicity: LD50 2661 mg/kg body weight (bw).

Acute dermal (rat) toxicity: LD50 >5,050 mg/kg bw.

Acute inhalation (rat) toxicity: LC50 >0.66 mg/l.

Primary eye irritation (rabbit): The product was found to be moderately
irritating to the eyes of rabbits.  The test material is classified as
Toxicity Category III for eye irritation.

Acute dermal irritation (rabbit): The product did not produce any dermal
irritation in rabbits.  The test material is classified as Toxicity
Category IV for dermal irritation.

Skin sensitization (guinea pigs): The product was not positive in guinea
pigs when tested for skin sensitization and is classified as a
non-sensitizer.

Developmental, reproductive, chronic and carcinogenic effects.  As part
of the original tolerance exemption that was published on October 5,
2000 [65 FR 59348], and again, in the further assessment of the
information presented in the tolerance exemption to allow for
post-harvest application, EPA accepted the following rationale regarding
the potential for phosphorous acid and its salts to cause long-term
developmental, reproductive, chronic, or carcinogenic effects: There is
adequate information available from literature sources to characterize
the toxicity of phosphorous acid.  Phosphorous acid can affect human
health through inhalation of mist, ingestion, and contact with the skin
and eyes.  In a concentrated form, it will cause corrosive effects
(burns or irreversible damage) to the eyes, skin, throat, digestive
tract, upper respiratory tract and nose.  Signs of overexposure to this
chemical are severe burning of eyes and skin, possible nausea and
vomiting, coughing, burning and tightness of the chest and shortness of
breath.  Based on corrosivity and the current use patterns for the
mineral acids, EPA did not require these studies as part of the
Reregistration Eligibility Decision (RED) on the Mineral Acids (EPA
738-R-029; December 1993).]

D. Aggregate Exposure

	1. Dietary exposure. [In the Federal Register Notice dated October 5,
2000 (65 FR 59346) (FRL-6599-1), EPA noted the establishment of an
exemption from the requirement of a tolerance for residues of
phosphorous acid and its ammonium, sodium and potassium salts in or on
all food commodities when used as an agricultural fungicide on food
crops.  This regulation eliminated the need to establish maximum
permissible levels for residues of phosphorous acid and its ammonium,
sodium and potassium salts.

On August 23, 2006, in the Federal Register (71 FR 36731-36736) (FRL
8084-3), EPA established an exemption from the requirement of a
tolerance for residues of phosphorous acid and its ammonium, sodium, and
potassium salts in or on all food commodities to allow for post-harvest
application to stored potatoes at 35,600 ppm or less of phosphorus acid.
 The regulation eliminated the need to establish maximum permissible
levels for residues of phosphorous acid and its ammonium, sodium and
potassium salts.

As previously noted, calcium salts of phosphorus acid are similar in
functionality to other salts, in particular potassium salts.  The key
difference between the two salt types is their oxidations states, which
should not be a factor, as the main pesticidal component of the active
ingredient are the phosphites, not their cations.  The Agency feels that
it is logical for the tolerance exemption to include other salts of
phosphorus acid that are similar in composition and residue profile.]

	i. Food. [Phosphorous acid rapidly dissociates to form hydrogen and
phosphite ions when applied to growing crops in the environment and
therefore, it has already been established that no dietary exposure is
expected from pre-harvest applications.  The degradates of phosphorous
acid, hydrogen and phosphite ions are important nutrients for plants and
animals.  Formation of these degradates however, may be compromised when
phosphorous acid is applied as a post-harvest treatment.  Since
post-harvest treatment of phosphorous acid to most agricultural
commodities is likely to occur in indoor storage facilities, the
oxidation process of phosphorous acid will most likely be slowed down.
The fact that the phosphorous acid at the time of post-harvest treatment
has not been oxidized to its degradates is clear, and it is unknown how
much this oxidation process reduces the potential dietary exposure to
phosphorous acid under the conditions of post-harvest treatment.
However, even with these uncertainties, the Agency believes that when
phosphorous acid is used as a post-harvest treatment at the recommended
application rate, the remaining residues of phosphorous acid will not
increase toxicity or add any new dietary exposure or risks and the
toxicity of phosphorous acid would still be considered to have a low
toxicity and will be considered safe.]

	ii. Drinking water. [No significant drinking water exposure is expected
to result from phosphorous acid when applied as a pre- and post-harvest
treatment to agricultural commodities, because phosphorous acid rapidly
dissociates to form hydrogen and phosphite ions and is very soluble in
water.  The hydrogen ions affect pH, but this is moderated by natural
means.]

	2. Non-dietary exposure. [There are no residential, school or day care
uses proposed for this product.  Since the proposed use pattern is for
pre- and post-harvest treatment on agricultural commodities, the
potential for non-occupational, non-dietary exposures to phosphorous
acid by the general population, including infants and children, is
highly unlikely.  Further, even if persons were exposed via the
non-occupational route, the low toxicity from a dilute application such
as the one evaluated by the Agency on agricultural commodities and
potatoes is safe and the primary hazards associated with concentrated
phosphorous acid (corrosivity and irritation) will be significantly
reduced because the end use products are diluted and the residues
following application are very low.]

E. Cumulative Effects

	[In assessing both the pre-harvest tolerance exemption published in
2000 and the post-harvest tolerance exemption in 2006, the Agency
considered all available information that related to the cumulative
effect of pesticide residues of phosphorous acid and residues of other
materials having a common mechanism of toxicity.  Especially important
in these assessments is the effect potential residues may have on
infants and children.  The Agency concluded the following: BPPD (EPA)
has considered the potential for cumulative effects of phosphorous acid
and other substances in relation to a common mechanism of toxicity.
Phosphorous acid may share a common metabolic mechanism with other salts
of phosphorous acid (such as calcium); however, due to the low order of
toxicity and lack of reported dietary toxicity associated with the use
of phosphorous fertilizers on crops, no cumulative effect from the use
of phosphorous acid is expected.]

F. Safety Determination

	1. U.S. population. [With respect to the potential for harmful effects
of phosphorous acid in the U.S. population and, in particular, the
segment of the population that includes infants and children, the Agency
has accepted the following rationale.  Aggregate exposure to phosphorous
acid is expected to be minimal.  There is very little potential for
exposure to phosphorous acid in drinking water and from non-dietary,
non-occupational exposures. This chemical will be applied pre- and
post-harvest treatment to agricultural commodities.  Once released into
the environment, the chemical rapidly dissociates to form hydrogen and
phosphite ions.  The hydrogen ions affect pH, but this is moderated by
natural means.  Many phosphite salts are generally recognized as safe
(GRAS). Therefore, the health risk to humans is negligible based on the
low toxicity of these ions and a low application rate for the active
ingredient, and one can conclude that there is a reasonable certainty
that no harm will result from aggregate exposure to phosphorous acid.]

	2. Infants and children. [With respect to infants and children, the
Agency has accepted the following rationale. Aggregate exposure to
phosphorous acid is expected to be minimal. There is very little
potential for exposure to phosphorous acid in drinking water and from
non-dietary, non-occupational exposures. This chemical will be applied
pre- and post-harvest treatment to agricultural commodities.  Once
released into the environment, the chemical rapidly dissociates to form
hydrogen and phosphite ions.  The hydrogen ions affect pH, but this is
moderated by natural means.  Many phosphite salts are ‘GRAS.’
Therefore, the health risk to humans is negligible based on the low
toxicity of and these ions and a low application rate for the active
ingredient. One can conclude that there is a reasonable certainty that
no harm will result to infants and children from aggregate exposure to
phosphorous acid residues.]

G. Effects on the Immune and Endocrine Systems

	[In 2006, the Agency determined that there is no evidence that
phosphorous acid affects the immune system, functions in a manner
similar to any known hormone, or that it acts as an endocrine
disruptor.]

H. Existing Tolerances

	[EPA has established a tolerance exemption for phosphorous acid under
40 CFR 180.1210.  All pre- and post-harvest agricultural food uses of
phosphorous acid and its salts are exempt from the requirement of a
tolerance.]

I. International Tolerances

	[No maximum residue levels (MRLs) have been established for phosphorous
acid by the Codex Alimentarius Commission (CODEX).]

 PAGE

 PAGE   3


[Federal Register Volume 84, Number 209 (Tuesday, October 29, 2019)]
[Notices]
[Page 57864]
[FR Doc No: 2019-23587]

=======================================================================
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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. CP20-6-000]

Southern Natural Gas Company, LLC; Notice of Request Under
Blanket Authorization

    Take notice that on October 18, 2019, Southern Natural Gas Company,
LLC, (SNG), 569 Brookwood Village, Suite 749, Birmingham, Alabama
35209, filed in Docket No. CP20-6-000 a prior notice request pursuant
to sections 157.205, and 157.216 of the Commission's regulations under
the Natural Gas Act, and SNG's blanket certificate issued in Docket No.
CP82-406-000. SNG proposes to abandon in place two compressor units at
its Rankin Compressor Station, located in Rankin County, Mississippi,
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 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, please contact FERC Online Support at
[email protected] or toll free at<PHONE_NUMBER>, or TTY,
contact<PHONE_NUMBER>.
    Any questions concerning this application may be directed to T.
Brooks Henderson, Director--Rates & Regulatory, Southern Natural Gas
Company, LLC, 569 Brookwood Village, Suite 749, Birmingham, Alabama
35209, by telephone at<PHONE_NUMBER>, or by fax at<PHONE_NUMBER>, or
by email at [email protected].
    Any person or the Commission's staff may, within 60 days after
issuance of the instant notice by the Commission, file pursuant to Rule
214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to
intervene or notice of intervention and pursuant to section 157.205 of
the regulations under the NGA (18 CFR 157.205), a protest to the
request. If no protest is filed within the time allowed therefore, the
proposed activity shall be deemed to be authorized effective the day
after the time allowed for filing a protest. If a protest is filed and
not withdrawn within 30 days after the allowed time for filing a
protest, the instant request shall be treated as an application for
authorization pursuant to section 7 of the NGA.
    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 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 EA.
    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 commenters will be
placed on the Commission's environmental mailing list and will be
notified of any meetings associated with the Commission's environmental
review process. Environmental commenters will not be required to serve
copies of filed documents on all other parties. However, the non-party
commenters, will not receive copies of all documents filed by other
parties or 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 3 copies of the protest or intervention to the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426.

    Dated: October 23, 2019.
Kimberly D. Bose,
Secretary.
[FR Doc. 2019-23587 Filed 10-28-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 179 (Monday, September 16, 2013)]
[Notices]
[Pages 56900-56901]
[FR Doc No: 2013-22427]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2013-N-0001]

Antiviral Drugs Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

    This notice announces a forthcoming meeting of a public advisory
committee of the Food and Drug Administration (FDA). The meeting will
be open to the public.

    Name of Committee: Antiviral Drugs Advisory Committee.
    General Function of the Committee: To provide advice and
recommendations to the Agency on FDA's regulatory issues.
    Date and Time: The meeting will be held on October 25, 2013,
from 8 a.m. to 5 p.m.
    Location: Sheraton Silver Spring Hotel, Cypress Ballroom, 8777
Georgia Ave., Silver Spring, MD. The hotel phone number is 301-589-
0800.
    Contact Person: Karen Abraham-Burrell, Food and Drug
Administration, Center for Drug Evaluation and Research, 10903 New
Hampshire Ave., Bldg. 31, Rm. 2417, Silver Spring, MD 20993-0002,
301-796-9001, FAX:<PHONE_NUMBER>, email<EMAIL_ADDRESS>or FDA
Advisory Committee Information Line, 1-800-741-8138<PHONE_NUMBER> in
the Washington, DC area). A notice in the Federal Register about
last minute modifications that impact a previously announced
advisory committee meeting cannot always be published quickly enough
to provide timely notice. Therefore, you should always check the
Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate advisory committee
meeting link, or call the advisory committee information line to
learn about possible modifications before coming to the meeting.
    Agenda: The committee will discuss new drug application (NDA)
204671, sofosbuvir (an NS5B polymerase inhibitor), manufactured by
Gilead Sciences, Inc., with a proposed indication for the treatment
of chronic hepatitis C infection, in combination with other agents
in adult patients with genotypes 1 to 6 and/or adult patients
awaiting liver transplantation.
    FDA intends to make background material available to the public
no later than 2 business days before the meeting. If FDA is unable
to post the background material on its Web site prior to the
meeting, the background material will be made publicly available at
the location of the advisory committee meeting, and the background
material will be posted on FDA's Web site after the meeting.
Background material is available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the
appropriate advisory committee meeting link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
October 9, 2013. Oral presentations from the public will be
scheduled between approximately 1 p.m. and 2 p.m. Those individuals
interested in making formal oral presentations should notify the
contact person and submit a brief statement of the general nature of
the evidence or arguments they wish to present, the names and
addresses of proposed participants, and an indication of the
approximate time requested to make their presentation on or before
October 1, 2013. Time allotted for each presentation may be limited.
If the number of registrants requesting to speak is greater than can
be reasonably accommodated during the scheduled open public hearing
session, FDA may conduct a lottery to determine the speakers for the
scheduled open public

hearing session. The contact person will notify interested persons
regarding their request to speak by October 2, 2013.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to
electrical outlets.
    FDA welcomes the attendance of the public at its advisory
committee meetings and will make every effort to accommodate persons
with physical disabilities or special needs. If you require special
accommodations due to a disability, please contact Karen Abraham-
Burrell at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory
committee meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for
procedures on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: September 10, 2013.
Jill Hartzler Warner,
Acting Associate Commissioner for Special Medical Programs.
[FR Doc. 2013-22427 Filed 9-13-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 79, Number 43 (Wednesday, March 5, 2014)]
[Notices]
[Pages 12509-12510]
[FR Doc No: 2014-04812]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0490]

Guidance for Industry and Food and Drug Administration Staff:
Investigational New Drug Applications for Minimally Manipulated,
Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for
Hematopoietic and Immunologic Reconstitution in Patients With Disorders
Affecting the Hematopoietic System; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a document entitled ``Guidance for Industry and FDA
Staff: Investigational New Drug Applications for Minimally Manipulated,
Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for
Hematopoietic and Immunologic Reconstitution in Patients With Disorders
Affecting the Hematopoietic System'' dated March

2014. The guidance document provides advice to potential sponsors, such
as cord blood banks, registries, transplant centers, or individual
physicians serving as sponsor-investigators, to assist in the
submission of an investigational new drug application (IND) for certain
hematopoietic progenitor cells from placental/umbilical cord blood
(HPC, Cord Blood), when such HPC, Cord Blood units are not licensed,
and when a suitable human leukocyte antigen (HLA) matched cord blood
transplant is needed for hematopoietic and immunologic reconstitution
in patients with disorders affecting the hematopoietic system that are
inherited, acquired, or result from myeloablative treatment and there
is no satisfactory alternative treatment available. If unlicensed HPC,
Cord Blood units are made available for clinical use, they must be
distributed under an IND. The guidance announced in this document
finalizes the draft guidance of the same title dated June 2013 and
supersedes the final guidance entitled ``Guidance for Industry and FDA
Staff: Investigational New Drug Applications (INDs) for Minimally
Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
Intended for Hematopoietic Reconstitution for Specified Indications''
dated June 2011.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

ADDRESSES: Submit written requests for single copies of the guidance to
the Office of Communication, Outreach and Development (HFM-40), Center
for Biologics Evaluation and Research (CBER), Food and Drug
Administration, 1401 Rockville Pike, Suite 200N, Rockville, MD 20852-
1448. Send one self-addressed adhesive label to assist the office in
processing your requests. The guidance may also be obtained by mail by
calling CBER at 1-800-835-4709 or<PHONE_NUMBER>. See the SUPPLEMENTARY
INFORMATION section for electronic access to the guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tami Belouin, Center for Biologics
Evaluation and Research (HFM-17), Food and Drug Administration, 1401
Rockville Pike, Suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a document entitled
``Guidance for Industry and FDA Staff: Investigational New Drug
Applications for Minimally Manipulated, Unrelated Allogeneic Placental/
Umbilical Cord Blood Intended for Hematopoietic and Immunologic
Reconstitution in Patients With Disorders Affecting the Hematopoietic
System,'' dated March 2014. The guidance provides advice to potential
sponsors to assist in the submission of an IND for certain HPC, Cord
Blood, when such HPC, Cord Blood units are not licensed in accordance
with title 21 of the Code of Federal Regulations part 601 (21 CFR part
601), and when a suitable HLA matched cord blood transplant is needed
for hematopoietic and immunologic reconstitution in patients with
disorders affecting the hematopoietic system that are inherited,
acquired, or result from myeloablative treatment and there is no
satisfactory alternative treatment available. If unlicensed HPC, Cord
Blood units are made available for clinical use, they must be
distributed under an IND meeting the applicable requirements in 21 CFR
part 312.
    In the Federal Register of June 17, 2013 (78 FR 36194), FDA
announced the availability of the draft guidance of the same title
dated June 2013. FDA received no comments on the draft guidance and
only editorial changes were made to improve clarity. The guidance
announced in this notice finalizes the draft guidance dated June 2013
and supersedes the final guidance entitled ``Guidance for Industry and
FDA Staff: Investigational New Drug Applications (INDs) for Minimally
Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
Intended for Hematopoietic Reconstitution for Specified Indications''
dated June 2011.
    The guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents FDA's
current thinking on this topic. It does not create or confer any rights
for or on any person and does not operate to bind FDA or the public. An
alternative approach may be used if such approach satisfies the
requirements of the applicable statutes and regulations.
    Elsewhere in this issue of the Federal Register, we also are
announcing the availability of another, related guidance entitled
``Guidance for Industry: Biologics License Applications for Minimally
Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood
Intended for Hematopoietic and Immunologic Reconstitution in Patients
With Disorders Affecting the Hematopoietic System.'' That guidance
supersedes the document entitled ``Guidance for Industry: Minimally
Manipulated, Unrelated, Allogeneic Placental/Umbilical Cord Blood
Intended for Hematopoietic Reconstitution for Specified Indications''
dated October 2009.

II. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; 21 CFR part 56 have been approved under
OMB control number 0910-0130; 21 CFR part 1271 have been approved under
OMB control number 0910-0543; and Form FDA 1571 has been approved under
OMB control number 0910-0014.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Electronic Access

    Persons with access to the Internet may obtain the guidance at
either http://www.fda.gov/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 27, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-04812 Filed 3-4-14; 8:45 am]
BILLING CODE 4160-01-P


December 19, 2008

MEMORANDUM

SUBJECT: 	Changes to the Materials Characterization Papers Resulting
from OMB 				Comments

FROM:	Michael Galbraith

		Office of Solid Waste

TO:		Docket ID No. EPA-HQ-RCRA-2008-0329

The attached documents are copies of the final Materials
Characterization Papers in support of the Advanced Notice of Proposed
Rulemaking –Identification of Nonhazardous Materials That Are Solid
Waste, which illustrates the changes EPA made to the documents as a
result of the review by the Office of Management and Budget (OMB).
These redline/strikeout copies resulted from a comparison of the final
versions with the versions EPA originally sent to OMB for review.

Note that OMB’s comments did not apply to all the material
characterization papers.  As such, those material characterization
papers are not included in the attachments.

Attachments


TO:  ASTM E06.54 Members and All Other Interested Parties
FROM:  Bob Ferguson
DATE:  November 15, 2019
RE:  November 19, 2019 Teleconference Agenda - ASTM E2515 and ASTM E3053 Task Groups

Agenda
11:30	Introductions
 General  -  Bob Ferguson, Task Group Facilitator
 Introduction to ASTM - Stephen F. Mawn, Director, Technical Committee Operations
 ASTM Collaboration Area  -  Rick Curkeet, E06.54 Subcommittee Chair
 Questions about process
12:00	ASTM E2515:  Standard Test Method for Determination of Particulate Matter Emissions Collected by a Dilution Tunnel
 Review of known areas where issues have been raised
 Substantive discussion of issues as time permits
12:50		Set next meeting date and time
12:55		Adjourn E2515 portion of call
1:00		ASTM E3053:  Standard Test Method for Particulate Matter Emissions from Wood
      Heaters Using Cordwood Test Fuel
 Review of known areas where issues have been raised
 Substantive discussion of issues as time permits
1:55		Set next meeting date and time
2:00		Adjourn E2515 portion of call


[Federal Register Volume 82, Number 178 (Friday, September 15, 2017)]
[Notices]
[Page 43359]
[FR Doc No: 2017-19665]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9035-2]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www2.epa.gov/nepa/ nepa/.

Weekly receipt of Environmental Impact Statements (EIS)
Filed 09/04/2017 Through 09/08/2017
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: https://cdxnodengn.epa.gov/cdx-nepa-public/action/eis/search.

EIS No. 20170175, Final, NPS, CA, Vista Grande Drainage Basin
Improvement Project, Golden Gate National Recreation Area, San
Francisco and San Mateo Counties, Review Period Ends: 10/15/2017,
Contact: Steven Ortega<PHONE_NUMBER>.
EIS No. 20170176, Draft, DOT, LA, Final Integrated Feasibility Report
and Environmental Impact Statement for the Houma Navigational Canal
Deepening Project, Terrebonne Parish, Louisiana, Comment Period Ends:
10/30/2017, Contact: Patricia S. Naquin<PHONE_NUMBER>.
EIS No. 20170177, Draft, AFS, SD, Black Hills Resilient Landscapes
Project, Comment Period Ends: 10/30/2017, Contact: Anne Davy 406-273-
1836.

Amended Notices

EIS No. 20170154, Draft, USACE, IL, The Great Lakes and Mississippi
River Interbasin Study--Brandon Road, Comment Period Ends: 10/02/2017,
Contact: Andrew Leichty<PHONE_NUMBER>; Revision to the FR Notice
Published 08/18/2017; Extending Comment Period from 10/02/2017 to 11/
16/2017.

    Dated: September 12, 2017.
Kelly Knight,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2017-19665 Filed 9-14-17; 8:45 am]
 BILLING CODE 6560-50-P