[Federal Register Volume 86, Number 148 (Thursday, August 5, 2021)]
[Notices]
[Pages 42845-42849]
[FR Doc No: 2021-16700]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-N-0270]

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 Institutional
Foodservice and Retail Food Stores Facility Types

AGENCY: Food and Drug Administration, Health and Human Services (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.

DATES: Submit written comments (including recommendations) on the
collection of information by September 7, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0799. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<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
Institutional Foodservice and Retail Food Stores Facility Types

OMB Control Number 0910-0799--Extension

I. Background

    From 1998 to 2008, FDA's National Retail Food Team conducted a
study 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 as
contributing factors to foodborne illness outbreaks at the retail
level. Specifically, data were collected by FDA Specialists in retail
and foodservice establishments at 5-year intervals (1998, 2003, and
2008) 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, and
     Contaminated Equipment/Cross-Contamination.
    FDA developed reports summarizing the findings for each of the
three data collection periods, which were released in 2000, 2004, and
2009 (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).
    Using this 10-year survey as a foundation, in 2013 to 2014, FDA
initiated a new study period. This study will span 10 years. FDA
completed the baseline data collection in select healthcare, schools,
and retail food store facility types in 2015 to 2016, and these data
are being evaluated for trends and significance. A second data
collection began in 2019 to 2020 and will be completed if it is safe to
do so (pending COVID-19 pandemic), and an additional data collection is
planned for 2023 to 2024 (the subject of this information collection
request extension). Three data collections are necessary to trend the
data.

    Table 1--Description of the Facility Types Included in the Survey
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           Facility type                         Description
------------------------------------------------------------------------
Healthcare Facilities.............     Hospitals and long-term care
                                        facilities foodservice
                                        operations that prepare meals
                                        for highly susceptible
                                        populations as defined as
                                        follows:

                                        Hospitals--A foodservice
                                        operation that provides for the
                                        nutritional needs of inpatients
                                        by preparing meals and
                                        transporting them to the
                                        patient's room and/or serving
                                        meals in a cafeteria setting
                                        (meals in the cafeteria may also
                                        be served to hospital staff and
                                        visitors).
                                        Long-term care
                                        facilities--A foodservice
                                        operation that prepares meals
                                        for the residents in a group
                                        care living setting such as
                                        nursing homes and assisted
                                        living facilities.
                                    Note: For the purposes of this
                                     study, healthcare facilities that
                                     do not prepare or serve food to a
                                     highly susceptible population, such
                                     as mental healthcare facilities,
                                     are not included in this facility
                                     type category.
Schools (K-12)....................  Foodservice operations that have the
                                     primary function of preparing and
                                     serving meals for students in one
                                     or more grade levels from
                                     kindergarten through grade 12. A
                                     school foodservice may be part of a
                                     public or private institution.
Retail Food Stores................  Supermarkets and grocery stores that
                                     have a deli department/operation as
                                     described as follows:
                                        Deli department/
                                        operation--Areas in a retail
                                        food store where foods, such as
                                        luncheon meats and cheeses, are
                                        sliced for the customers and
                                        where sandwiches and salads are
                                        prepared onsite or received from
                                        a commissary in bulk containers,
                                        portioned, and displayed. Parts
                                        of deli operations may include:
                                        Salad bars, pizza
                                        stations, and other food bars
                                        managed by the deli department
                                        manager.
                                        Areas where other foods
                                        are cooked or prepared and
                                        offered for sale as ready-to-eat
                                        and are managed by the deli
                                        department manager.
                                    Data will also be collected in the
                                     following areas of a supermarket or
                                     grocery store, if present:
                                        Seafood department/
                                        operation--Areas in a retail
                                        food store where seafood is cut,
                                        prepared, stored, or displayed
                                        for sale to the consumer. In
                                        retail food stores where the
                                        seafood department is combined
                                        with another department (e.g.,
                                        meat), the data collector will
                                        only assess the procedures and
                                        practices associated with the
                                        processing of seafood.
                                        Produce department/
                                        operation--Areas in a retail
                                        food store where produce is cut,
                                        prepared, stored, or displayed
                                        for sale to the consumer. A
                                        produce operation may include
                                        salad bars or juice stations
                                        that are managed by the produce
                                        manager.
------------------------------------------------------------------------

    The results of this 10-year study period will be used to:
     Develop retail food safety initiatives, policies, and
targeted intervention strategies focused on controlling foodborne
illness risk factors;
     provide technical assistance to State, local, tribal, and
territorial regulatory professionals;
     identify FDA retail work plan priorities; and
     inform FDA resource allocation to enhance retail food
safety nationwide.
    The statutory basis for FDA conducting this study is derived from
the Public Health Service Act (PHS Act) (42 U.S.C. 243, section
311(a)). Responsibility for carrying out the provisions of the PHS Act
relative to food protection was transferred to the Commissioner of Food
and Drugs in 1968 (21 CFR 5.10(a)(2) and (4)). Additionally, the
Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.) and the
Economy Act (31 U.S.C. 1535) require FDA to provide assistance to other
Federal, State, and local government bodies.
    The objectives of this study are to:
     Identify the least and most often occurring foodborne
illness risk factors and food safety behaviors/practices in select
retail food establishments within the United States.
     determine the extent to which food safety management
systems and the presence of a certified food protection manager impact
the occurrence of foodborne illness risk factors and food safety
behaviors/practices; and
     determine whether the occurrence of foodborne illness risk
factors and food safety behaviors/practices in delis differs based on
an establishment's risk categorization and status as a single-unit or
multiple-unit operation (e.g., establishments that are part of an
operation with two or more units).
    The methodology to be used for this information collection is
described as follows. To obtain a sufficient number of observations to
conduct statistically significant analysis, FDA will conduct
approximately 400 data collections in each facility type. This sample
size has been calculated to provide for sufficient observations to be
95 percent confident that the compliance percentage is within 5 percent
of the true compliance percentage.
    A geographical information system database containing a listing of
businesses throughout the United States provides the establishment
inventory for the data collections. FDA samples establishments from the
inventory based on the descriptions in table 1. FDA does not intend to
sample 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 intent is to sample establishments that fall under risk categories
2 through 4.
    FDA has approximately 23 Regional Retail Food Specialists
(Specialists) who 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 Center
for Food Safety and Applied Nutrition personnel in the application and
interpretation of the FDA Food Code (Ref. 5).
    Sampling zones have been established that are equal to the 175-mile
radius around a Specialist's home location. The sample is selected
randomly from among all eligible establishments located within these
sampling zones. The Specialists are generally located in major
metropolitan areas (i.e., population centers) across the contiguous
United States. Population centers usually contain a large concentration
of the establishments FDA intends to sample. Sampling from the 175-mile
radius sampling zones around the Specialists' home locations provides
three advantages to the study:
    1. It provides a cross-section of urban and rural areas from which
to sample the eligible establishments.
    2. It represents a mix of small, medium, and large regulatory
entities having jurisdiction over the eligible establishments.

    3. It reduces overnight travel and therefore reduces travel costs
incurred by the Agency to collect data.
    The sample for each data collection period is 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 have been selected for
each Specialist for cases where the institutional foodservice, school,
or retail food store facility is misclassified, closed, or otherwise
unavailable, unable, or unwilling to participate.
    Prior to conducting the data collection, Specialists contact the
State or local jurisdiction that has regulatory responsibility for
conducting retail food inspections for the selected establishment. The
Specialist verifies with the jurisdiction that the facility has been
properly classified for the purposes of the study and is still in
operation. The Specialist ascertains 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 is extended to the State or local regulatory authority to
accompany the Specialist on the data collection visit.
    A standard form is used by the Specialists during each data
collection. 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.'' The information in Section 1--
``Establishment Information'' of the form is obtained during an
interview with the establishment owner or person in charge by the
Specialist and includes a standard set of questions.
    The information in Section 2--``Regulatory Authority Information''
is obtained during an interview with the program director of the State
or local jurisdiction that has regulatory responsibility for conducting
inspections for the selected establishment. Section 3--``Foodborne
Illness Risk Factor and Food Safety Management System Assessment''
includes three parts: Part A for tabulating the Specialists'
observations of the food employees' behaviors and practices in limiting
contamination, proliferation, and survival of food safety hazards; Part
B for assessing the food safety management system being implemented by
the facility; and Part C for assessing the frequency and extent of food
employee hand washing. The information in Part A is collected from the
Specialists' direct observations of food employee behaviors and
practices. Infrequent, nonstandard questions may be asked by the
Specialists if clarification is needed on the food safety procedure or
practice being observed. The information in Part B is collected by
making direct observations and asking followup questions of facility
management to obtain information on the extent to which the food
establishment has developed and implemented food safety management
systems. The information in Part C is collected by making direct
observations of food employee hand washing. No questions are asked in
the completion of Section 3, Part C of the form.
    FDA collects the following information associated with the
establishment's identity: Establishment name, street address, city,
State, ZIP Code, county, industry segment, and facility type. The
establishment identifying information is collected to ensure the data
collections are not duplicative. Other information related to the
nature of the operation, such as seating capacity and number of
employees per shift, is also collected. Data will be consolidated and
reported in a manner that does not reveal the identity of any
establishment included in the study.
    FDA has collaborated with the Food Protection and Defense Institute
to develop a web-based platform in FoodSHIELD to collect, store, and
analyze data for the Retail Risk Factor Study. This platform is
accessible to State, local, territorial, and tribal regulatory
jurisdictions to collect data relevant to their own risk factor
studies. For the 2015 to 2016 data collection, FDA piloted the use of
hand-held technology for capturing the data onsite during the data
collection visits. The tablets that were made available for the data
collections were part of a broader FDA initiative focused on internal
uses of hand-held technology. The tablets provided for the data
collection presented several technical and logistical challenges and
increased the time burden associated with the data collection as
compared to the manual entry of data collections. For these reasons,
FDA will not be incorporating use of hand-held technology in subsequent
data collections during the 10-year study period.
    When a data collector is assigned a specific establishment, he or
she conducts the data collection and enters the information into the
web-based data platform. The interface will support the manual entering
of data, as well as the ability to directly enter information in the
database via a web browser.
    The burden for the 2023 to 2024 data collection is as follows. For
each data collection, the respondents will include: (1) The person in
charge of the selected facility (whether it be a healthcare facility,
school, or supermarket/grocery store); and (2) the program director (or
designated individual) of the respective regulatory authority. To
provide the sufficient number of observations needed to conduct a
statistically significant analysis of the data, FDA has determined that
400 data collections will be required in each of the three facility
types. Therefore, the total number of responses will be 2,400 (400 data
collections x 3 facility types x 2 respondents per data collection).
    The burden associated with the completion of Sections 1 and 3 of
the form is specific to the persons in charge of the selected
facilities. The burden includes the time it will take the person in
charge to accompany the data collector during the site visit and answer
the data collector's questions. The burden related to the completion of
Section 2 of the form is specific to the program directors (or
designated individuals) of the respective regulatory authorities. This
burden includes the time it will take to answer the data collectors'
questions and is the same regardless of the facility type.
    In the Federal Register of February 18, 2021 (86 FR 10087), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. FDA received one comment.
    (Comment) An interested citizen submitted the following comment:
    a. The previous 10-year study conducted by FDA did not mention
negative trends in the ``other'' category, which included information
about contamination risk factors as they relate to food or color
additives, poisonous or toxic materials, or storage of poisonous or
toxic materials for retail sale. This negative trend should be
reported.
    b. In the 2013 to 2014 report on restaurants the ``other''
contamination risk factor did not appear in the report. This should
remain the same as the previous 10-year study for comparison purposes.
    c. FDA should keep chemicals as a risk factor for future research
on the occurrence of foodborne illness risk factors.
    (Response) FDA acknowledges the submission of the question from a
concerned citizen and provides the following response:

    a. FDA acknowledges the commenter's concern on a perceived lack of
reporting on negative trends within the previous 10-year study.
    b. FDA report on the results of the 2013 to 2014 data collection
was the first report with the new study design of the 10-year study.
One of the significant design changes from the 1998 to 2008 Study is
the reduction of the number of data items from 42 to 10. The focus on
the 10 primary data items provides the opportunity to obtain enough
observations of food safety practices and procedures to report
statistically significant study conclusions and correlations.
    In an effort to focus messaging on the most prevalent food safety
practices and behaviors found out of compliance, secondary data items
(items 11-19) were not reported at that time. FDA focused the report on
the primary 10 data items that directly correspond with the foodborne
illness risk factors included in the study. The new study design
includes ``Other Areas of Interest'' that support the primary data
items or track an area that is not likely to have a sufficient enough
number of observations for statistical purposes but is an important
food safety practice within the retail segment of the industry--such as
Item 18, ``Toxic materials are identified, used, and stored properly as
outlined in the marking instructions'', (Attachment B). The current
data collection continues to collect information on the provisions
within the food code that address the safe storage, handling, and use
of toxic and poisonous substances. If significant findings occur, FDA
is committed to reporting those findings. From the 2015 data collection
forward, FDA will be publishing a topline summary report to include
information on data items 11-18. These reports can be accessed at
https://www.fda.gov/retailfoodriskfactorstudy.
    c. While not listed as one of the five main foodborne illness risk
factors in the current study design, controlling chemicals and toxic
substances in food service facilities is important to prevent injury
and illness and FDA recognizes this. The information gathered in Data
Item 18 as described above helps FDA keep a pulse on risky behaviors
surrounding toxic or poisonous materials in retail facilities. The
purpose of the current 10-year study is primarily to collect
information on the five foodborne illness risk factors and study to
elucidate relationships between the foodborne illness risk factors and
food safety management systems, and certified food protection managers.
    To calculate the estimate of the hours per response, FDA uses the
average data collection duration for similar facility types during the
FDA's 2008 Risk Factor Study (Ref. 3) plus an additional 30 minutes
(0.5 hours) for the information related to Section 3, Part B of the
form. FDA estimates that it will take the persons in charge of
healthcare facility types, schools, and retail food stores 150 minutes
(2.5 hours), 120 minutes (2 hours), and 180 minutes (3 hours),
respectively, to accompany the data collectors while they complete
Sections 1 and 3 of the form. FDA estimates that it will take the
program director (or designated individual) of the respective
regulatory authority 30 minutes (0.5 hours) to answer the questions
related to Section 2 of the form. This burden estimate is unchanged
from the last data collection. Hence, the total burden estimate for a
data collection in healthcare facility types is 180 minutes (150 + 30)
(3 hours), in schools is 150 minutes (120 + 30) (2.5 hours), and retail
food stores is 210 minutes (180 + 30) (3.5 hours).
    Based on the number of entry refusals from the 2015 to 2016
baseline data collection, we estimate a refusal rate of 2 percent for
the data collections within healthcare, school, and retail food store
facility types. The estimate of the time per non-respondent is 5
minutes (0.08 hours) for the person in charge to listen to the purpose
of the visit and provide a verbal refusal of entry.
    FDA estimates the burden of this collection of information as
follows:

                                                                         Table 2--Estimated Annual Reporting Burden \1\
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                                                                                Number of
                                                    Number of       Number of     Total annual   Number of non-   responses per   Total annual                                           Total
                    Activity                       respondents    responses per     responses      respondents        non-        non-responses       Average burden per response        hours
                                                                   respondent                                      respondent
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2023-2024 Data Collection (Healthcare                       400               1             400  ..............  ..............  ..............  2.5.................................      1,000
 Facilities)--Completion of Sections 1 and 3.
2023-2024 Data Collection (Schools)--Completion             400               1             400  ..............  ..............  ..............  2...................................        800
 of Sections 1 and 3.
2023-2024 Data Collection (Retail Food Stores)--            400               1             400  ..............  ..............  ..............  3...................................      1,200
 Completion of Sections 1 and 3.
2023-2024 Data Collection-Completion of Section           1,200               1           1,200  ..............  ..............  ..............  0.5 (30 minutes)....................        600
 2--All Facility Types.
2023-2024 Data Collection-Entry Refusals--All    ..............  ..............  ..............              24               1              24  0.08 (5 minutes)....................       1.92
 Facility Types.
                                                ------------------------------------------------------------------------------------------------------------------------------------------------
    Total......................................  ..............  ..............  ..............  ..............  ..............  ..............  ....................................   3,601.92
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.

II. References

    The following references are on display in the Dockets Management
Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852,<PHONE_NUMBER> and are available for viewing
by interested persons between 9 a.m. and 4 p.m., Monday through Friday;
they are also available electronically at https://www.regulations.gov.
FDA has verified the website addresses, as of the date this document
publishes in the Federal Register, but websites are subject to change
over time.

1. ``Report of the FDA Retail Food Program Database of Foodborne
Illness Risk

Factors (2000).'' Available at: https://wayback.archive-it.org/7993/20170406023019/https://www.fda.gov/downloads/Food/GuidanceRegulation/UCM123546.pdf.
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: https://wayback.archive-it.org/7993/20170406023011/https://www.fda.gov/downloads/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/UCM423850.pdf.
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: https://wayback.archive-it.org/7993/20170406023004/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm224321.htm.
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).'' (2010). Available at: https://wayback.archive-it.org/7993/20170406022950/https://www.fda.gov/Food/GuidanceRegulation/RetailFoodProtection/FoodborneIllnessRiskFactorReduction/ucm223293.htm.
5. ``FDA Food Code.'' Available at: https://www.fda.gov/food/retail-food-protection/fda-food-code.

    Dated: July 28, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-16700 Filed 8-4-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 21 (Monday, February 2, 2015)]
[Notices]
[Page 5593]
[FR Doc No: 2015-01955]

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SECURITIES AND EXCHANGE COMMISSION

Sunshine Act Meeting

    Notice is hereby given, pursuant to the provisions of the
Government in the Sunshine Act, Public Law 94-409, that the Securities
and Exchange Commission will hold an Open Meeting on Wednesday,
February 4, 2015 at 10:00 a.m., in the Auditorium, Room L-002.
    The subject matter of the Open Meeting will be:
     The Commission will consider whether to approve the 2015
budget of the Public Company Accounting Oversight Board and will
consider the related annual accounting support fee for the Board under
Section 109 of the Sarbanes-Oxley Act of 2002.
    At times, changes in Commission priorities require alterations in
the scheduling of meeting items.
    For further information and to ascertain what, if any, matters have
been added, deleted or postponed, please contact: The Office of the
Secretary at<PHONE_NUMBER>.

    Dated: January 28, 2015.
Lynn M. Powalski,
Deputy Secretary.
[FR Doc. 2015-01955 Filed 1-29-15; 11:15 am]
BILLING CODE 8011-01-P


[Federal Register: March 7, 2008 (Volume 73, Number 46)]
[Proposed Rules]
[Page 12354-12357]
[DOCID:fr07mr08-29]

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DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

49 CFR Part 571

Federal Motor Vehicle Safety Standards No. 121; Air Brake Systems

AGENCY: National Highway Traffic Safety Administration (NHTSA), DOT.

ACTION: Denial of petition for rulemaking.

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SUMMARY: This Notice denies a petition by Mr. Wayne Walch of TP
Trucking in which the petitioner requested three changes to Federal
Motor Vehicle Safety Standard (FMVSS) No. 121, Air brake systems,
related to the air compressor operation and low air pressure warning
system. After reviewing the petition and the available real world data,
the agency has decided to deny it in its entirety because one of the
suggested changes is already in the standard, the second would not
result in any measurable safety benefit, and the third was, among other
things, not described in sufficient detail for the agency to evaluate
its function or purpose.

FOR FURTHER INFORMATION CONTACT: For non-legal issues, you may contact
Mr. Jeff Woods, Office of Crash Avoidance Standards, NHTSA, 1200 New
Jersey Avenue, SE., Washington, DC 20590 (Telephone:<PHONE_NUMBER>)
(FAX:<PHONE_NUMBER>). For legal issues, you may contact Mr. Ari Scott,
Office of the Chief Counsel, NHTSA, 1200 New Jersey Avenue, SE.,
Washington, DC 20590 (Telephone:<PHONE_NUMBER>) (FAX:<PHONE_NUMBER>).

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. General Description of Air Brake Systems and FMVSS No. 121
Requirements
III. Function of Low Air Pressure Warning and Gauges in Normal and
Emergency Braking Conditions
IV. Real World Data
V. Agency Analysis and Decision
VI. Conclusion

I. Background

    The agency received a petition for rulemaking dated October 20,
2006, from Mr. Wayne Walch of TP Trucking, located in Eagle Point,
Oregon. The petitioner suggested three improvements related to the air
compressor operation and low air pressure warning system, which he
believed would make air brake systems safer, and requested that Federal
Motor Vehicle Safety Standard (FMVSS) No. 121, Air brake systems, be
changed accordingly. These suggestions include:
     A warning device that would activate when the air
compressor begins a new cycle.
     A warning device that would activate if the air compressor
exceeds a predetermined amount of time to reach the cut-out pressure.
     A warning device that would activate just before the
beginning of the air compressor cycle.
    In his petition, Mr. Walch describes the typical operation of a low
pressure warning system in which an audible warning signal is activated
when the reservoir pressure is at 55 pounds per square inch (psi) or
below, or one half of the compressor governor cutout pressure,
whichever is less. The petitioner states that he believes this system
is not robust as it provides no indication of continual air loss or
when the compressor is constantly running and this can result in a
dangerous situation.
    In arguing the merits of the petition, the petitioner describes
several scenarios in which the recommended systems would operate.
First, the petitioner describes a scenario in which a system has an air
leak and the compressor keeps running continuously. As the driver
applies the brakes, the compressor cannot maintain the needed pressure,
and the driver loses his brakes. If the truck is traveling down hill,
the driver could have a serious crash in this situation. The petitioner
states that even if the spring-operated parking brakes activate, they
do not have the stopping efficiency as the normal service brakes. The
petitioner further states that if the parking brakes activate due to
that condition, the vehicle could stop in an unsafe area, and that most
drivers will not know how to release the spring parking brakes. As
such, the petition asks for the above three changes to FMVSS No. 121 to
make air brakes safer. They are as follows:
    1. Provide an indication to the driver upon air compressor cut-in.
Thus if the driver is aware that the air compressor is cycling but the
brakes aren't being used, the driver would be alerted to air system
leakage.
    2. Set the time on new vehicles for the air compressor to increase
system pressure from cut-in to cut-out pressure. If the system is
taking too long to build pressure, then a warning needs to be displayed
to the driver.
    3. Require a low air pressure warning device that activates just
before the start of the air compressor cycle. Items 1 and 2 above will
prevent this.

II. General Description of Air Brake Systems and FMVSS No. 121
Requirements

    The operation of an air brake system relies on compressed air
stored in reservoirs (tanks) mounted on the vehicle (truck, bus, or
trailer). By storing compressed air in the reservoirs, the air is
readily available to make rapid application of the brakes possible.
When the driver applies the service brakes, the compressed air flows
from the reservoirs into the service brake chambers that actuate the
brake mechanism at each wheel. The air in the reservoirs is replenished
by an air compressor on the engine of the truck or bus, which is
controlled by a governor that activates the air compressor (cut-in
pressure) and then turns off the air compressor once the reservoirs are
fully charged (cut-out pressure). Trailers are also equipped with
reservoirs, which receive their air supply from a towing vehicle that
is typically a truck or truck tractor. In the case of multiple trailer
combination vehicles, the tractor supplies air to all of the trailers
in the combination.
    As the driver applies the brakes, the air flows from the reservoirs
into the service brake chambers at a pressure corresponding to the
position of the brake pedal (treadle valve). Therefore, a light brake
application would typically result in 10 to 20 psi of compressed air in
the brake chambers, and a hard brake application would typically result
in 40 psi or higher pressures in the brake chambers. Since the brake
chambers are filled with compressed air taken from the reservoirs and
upon releasing the service brakes the air is vented to the atmosphere,
the air pressure in the reservoirs becomes slightly depleted whenever
the brakes are applied. When the reservoir pressure drops to cut-in
pressure, the governor activates the air compressor to build the system
pressure back up to the cut-out pressure.
    The process of the air compressor activating at reservoir cut-in
pressure, then building to reservoir cut-out pressure, is known as
compressor cycling, and the time between cycles can vary greatly among
vehicle types and the type of driving that is experienced. The most
frequent compressor cycling occurs in stop-and-go operations, such as
experienced by transit buses and refuse trucks, whereas the least
frequent compressor cycling would typically be on a tractor trailer
combination vehicle being operated at highway speeds with infrequent
brake applications.
    The service brake system on air braked vehicles is typically split
into a primary and a secondary air system. The primary system usually
controls the brakes on the drive axle(s) and the secondary system
controls the brakes on the steer axle. Both systems have their own
reservoirs that are typically fed by a supply reservoir that receives
air directly from the air compressor. The primary and secondary air
reservoirs are equipped with check valves for isolation so that a loss
of pressure in one system does not cause a loss of pressure in the
other system. In case one system loses pressure, the remaining system
still provides an emergency braking capability on the vehicle, as well
as continuing to operate any trailer service brakes, and keeps the
parking brakes in the released position. Most parking brakes on heavy
vehicles are of the spring brake design that require adequate brake
system air pressure in order to release them so the vehicle can be
moved.
    FMVSS No. 121 has several requirements relating to the reservoirs
and air compressor systems on trucks, buses, and trailers. The minimum
size of the reservoirs is specified in FMVSS No. 121 so that an
adequate reserve of air is available to repeatedly apply the brakes
without an excessive loss of system air pressure. For trucks and buses,
S<IP_ADDRESS> requires that the total reservoir volume (combined volume of
primary, secondary, and supply reservoirs) is at least 12 times the
combined volume of all of the service brake chambers on the vehicle.
Slight exceptions are provided in Table V--Brake Chamber Rated Volumes,
so that vehicle manufacturers can install long-stroke brake chambers in
place of standard-stroke brake chambers without having to increase the
size of the reservoirs. For trailers, S<IP_ADDRESS> requires that trailers
have a reservoir capacity that is at least eight times the combined
volume of the brake chambers, and again an exception is provided via
Table V for the use of long-stroke brake chambers.
    S5.1.1 Air compressor requires that an air compressor has
sufficient capacity to increase the pressure in the reservoirs from 85
psi to 100 psi within the time, in seconds, expressed by the equation:
[Actual reservoir capacity x

25] / [required reservoir capacity], with the engine at maximum
recommended r.p.m. Thus if a truck had minimum-sized air reservoirs,
the compressor must be able to reach 100 psi from 85 psi within 25
seconds with the engine at maximum recommended rated speed. S<IP_ADDRESS>
Air compressor cut-in pressure requires that the governor cut-in
pressure is at least 85 psi for a bus and at least 100 psi for a truck.
    S5.1.4 Pressure gauge requires a pressure gauge that is visible to
the driver for each service brake system. In a typical split air brake
system there are two independent air subsystems (primary and secondary)
that each have a reservoir or series of reservoirs. The air pressure
gauge has two pressure indicators (pointers)--one for the primary
system, and one for the secondary system, or, two separate gauges can
be used with one gauge provided for each system.
    S5.1.5 Warning signal requires a low air pressure warning signal
that is either visible to the driver, or if it is not directly in front
of the driver, is both visible and audible. The warning signal must
activate when the pressure in any reservoir system is below 60 psi and
the vehicle's ignition is in the ``on'' position.

III. Function of Low Air Pressure Warning and Gauges in Normal and
Emergency Braking Conditions

    During normal driving, the reservoir systems are automatically
recharged by the air compressor, and the driver can monitor the air
pressure gauges to see that the air pressure in the reservoirs is
staying between the cut-in and cut-out pressure limits. Most drivers of
air-braked vehicles are aware of the function of the low air pressure
warning signal and air pressure gauges on heavy vehicles. The vast
majority of drivers of air-braked vehicles have commercial drivers
licenses (CDL's). In order to obtain a CDL with an endorsement to drive
vehicles with air brakes, drivers are required to demonstrate that they
possess the knowledge and skills to operate a vehicle equipped with air
brakes. After starting the engine, the air brake system builds pressure
in the primary and secondary systems as indicated by the gauges, and
the low pressure warning turns off indicating normal system operation.
However, the minimum pressure for the low air pressure warning system
activation as required in FMVSS No. 121 is ``below 60 psi'' which is
slightly higher than stated by the petitioner (55 psi, or one-half the
compressor governor cut-out pressure, whichever is less). The
petitioner cited the North American Standard Out-of-Service Criteria
for the low pressure warning device published by the Commercial Vehicle
Safety Alliance and these air pressure values are slightly lower than
required by FMVSS No. 121 that applies to the manufacturers of new
vehicles. To ensure compliance with the ``below 60 psi'' requirement in
FMVSS No. 121, the actual low pressure warning typically activates
slightly above 60 psi when measured on vehicles.
    There are several common types of brake system failures that can
cause the low pressure warning signal to activate. To begin, minor
leaks in the system can often be overcome by the capacity of the air
compressor to re-supply air to the brake system. However, this
discussion focuses on substantial leaks and failures that the air
compressor cannot overcome, as well as failures of the air compressor
itself.
    A substantial leak in a brake hose supplying a service brake
chamber, or in a service brake chamber (e.g., due to a failed
diaphragm), will result in leakage whenever the brake pedal is applied.
If the leak is sufficiently large and the brake pedal is applied for a
long duration, the pressure in either the primary or secondary
reservoir may become sufficiently low to activate the warning signal,
which is required to activate when the air pressure in the service
reservoir system is below 60 psi. However, the remaining service brake
system (secondary or primary) will remain intact and provide for an
emergency braking capability, and will continue to keep the parking
brakes released. The driver would be able to determine by viewing the
air pressure gauges the rate of pressure loss and whether the loss was
in the primary or secondary system.
    Failures or leaks can also occur in the air supply portion of the
system, including the governor, air compressor, compressor discharge
hose, and the air dryer located between the air compressor and the
service reservoirs. Whether the compressor does not cut-in, or its
discharge air is vented to atmosphere because of a hose failure
downstream of the compressor, the result is that as the driver depletes
air in both reservoir systems during the application of the service
brakes, the pressure in both the primary and secondary systems
continues to drop until the low-pressure warning system activates.
Typically, the primary system will activate the low pressure warning
signal first while the secondary system will have a higher pressure. At
this point the vehicle is in emergency braking mode and the driver has
the ability to pull off the roadway. If for some reason the brakes were
repeatedly applied, the pressure in both the primary and secondary
systems would become further depleted and the spring brakes would
eventually apply automatically which would also bring the vehicle to a
stop. Truck drivers with CDLs are generally knowledgeable about these
aspects of air brake system failures and the importance and meaning of
low pressure warning signals.

IV. Real World Data

    The petitioner cites two scenarios for truck crashes that it states
are related to the inadequacy of the currently required low air
pressure warning system. The first is runaway trucks on downgrades that
the petitioner claims is caused by air leaks. The petitioner provided
no data to support this conclusion. Similarly, the agency is not aware
that this is a prevalent crash mode. Our experience indicates that
runaway truck crashes are most often due to brake fade from overheated
and/or out-of-adjustment S-cam drum brakes that result in a loss of
brake effectiveness, often exacerbated by excessive speed on a
downgrade. We have no indications that runaway truck crashes are being
caused by air leaks or contributed to by inadequate low pressure
warning systems.
    The other crash scenario presented by the petitioner was a truck
stopping in an unsafe area because of an air leak that caused the
parking brakes to apply and most drivers would not know how to move the
vehicle. While it is true that this can happen, the agency has no
indications of widespread problems with trucks being stranded on
roadways or in unsafe areas due to loss of air pressure in the brake
system and being involved in crashes. The petitioner also did not
provide such data. Additionally, as we have previously stated, the
current low-pressure warning system already alerts the driver of a
substantial loss of air pressure and the truck's braking system can be
operating in the emergency braking mode. As such, the driver can still
make several brake applications to safely bring the truck to a stop off
of a travel lane.

V. Agency Analysis and Decision

    The first requested change made by the petitioner is:

    There needs to be a way to make the driver aware of when the air
compressor is starting a new cycle. This lets the driver know there
is a loss of air in the system. If he is not using the brakes and
the air compressor is cycling he should stop the vehicle and do an
inspection for an air leak or call for repairs to the air system
before continuing on or before a possible accident on a downhill
grade.

    The agency believes that this change would mean that a lamp on the
instrument panel would illuminate (or some other type of indicator
would signal) every time that the air compressor cycled on at cut-in
pressure. Since cycling of the compressor occurs during normal
operation of a vehicle equipped with an air brake system, the agency
believes that most truck drivers would find this to be a nuisance,
particularly when driving at night. The agency's fleet evaluation
experience in the early 1990's with antilock brake systems (ABS)
warning lamps was that drivers would sometimes remove the bulb or cover
it with opaque tape because of a perceived nuisance (when in fact it
was indicating a malfunction in the ABS that, under hard braking, could
result in a loss-of-control crash). A warning system that activates
during normal operation may have a limited safety benefit, and
activations are more effective when they only occur when there is a
condition that warrants some type of intervention by the driver.
Therefore, we do not believe it would be appropriate to adopt the
petitioner's first request. However, we note that neither FMVSS No.
101, Controls and Displays, nor FMVSS No. 121 prohibits the addition of
a compressor cycling lamp, if a truck operator chooses to have such a
system installed.
    The second requested change is:

    They need to set the time on new vehicles at the factory on how
long it takes the air compressor at the start of its cycle to meet
the cut off pressure. If it is taking to[o] long or continuous
running occurs there needs to be something to warn the driver there
is a major problem. This is a very unsafe situation and should have
a priority warning to the driver.

    Regarding the requested change by the petitioner to set the
required time for air pressure build time, we note that this facet of
air brake systems is addressed in the previously discussed section
S5.1.1 in FMVSS No. 121, which requires the air compressor to have
sufficient capacity to increase the air system pressure from 85 to 100
psi in the specified amount of time. However, this requirement allows
for some variation in the amount of time needed to charge the air
system. Under FMVSS No. 121, the time for charging the air system is
measured with the engine at maximum rated speed, so the actual charging
time during normal driving can vary based upon actual engine speed and
gear selection. Compared to charging time with the engine at maximum
rated speed, the charging time would be longer when the truck is
sitting at idle. Other factors, such as the frequency of brake
application, number of towed units, air being supplied to increase air
suspension pressure, etc., would cause air to be depleted at the same
time the air compressor is charging the system. Therefore, these would
also affect the charging time, and we believe that requiring a warning
to activate when a constant time period has elapsed is an impracticable
requirement, given the variable nature of the charging period under the
current regulatory scheme. We note that our safety standard already
regulates performance in the area of air pressure charging time, but we
believe that it does so more appropriately than the proposed change.
For this reason, we are not adopting the petitioner's second request.
    The final requested change is:

    It would be some help to have a low air pressure warning device
that comes on just before the start of the air compressor cycle.
When this low air warning comes on the vehicle is in a dangerous
situation. Number 1 and 2 will prevent this.

    The third requested change in the petition is not clearly defined
for the agency to fully evaluate. The statement ``just before the start
of the air compressor cycle'' has two meanings. The first meaning is a
pressure slightly above the cut-in pressure, e.g., approximately 105 to
110 psi. The second meaning is a pressure slightly below the cut-in
pressure, e.g., approximately 90 to 95 psi. Based upon the information
in the petition, the agency does not understand the concept of this
warning lamp, and how its operation differs from the currently-required
low pressure warning signal required in FMVSS No. 121, other than being
set to activate at a higher air pressure. It also seems nearly
identical to/redundant with the petitioner's first requested change, as
this warning would activate just before the start of a new air
compressor cycle, and then the warning from the first request would
activate when the compressor began that new cycle. Furthermore, we note
that activation of a warning signal at either of these pressures would
result in the warning being activated extremely frequently, including
during normal driving operations. Given these reasons, we are denying
the petitioner's third requested change.

VI. Conclusion

    Based upon this review of the petition, the agency is denying it.
In summary, it appears that one or two warning lamps would be required
to activate upon each cut-in of the compressor cycle, and this would
not provide additional information to the driver beyond the information
that is already available from the existing air pressure gauges. In
addition, we believe that warning systems that activate frequently
during normal driving conditions can be perceived as a nuisance, and
may have limited safety effect. Finally, we are not aware of any known
safety problems not addressed by the existing low pressure warning
signal requirements in FMVSS No. 121.

    Issued: March 3, 2008.
Stephen R. Kratzke,
Associate Administrator for Rulemaking.
[FR Doc. E8-4460 Filed 3-6-08; 8:45 am]

BILLING CODE 4910-59-P


[Federal Register Volume 84, Number 96 (Friday, May 17, 2019)]
[Notices]
[Page 22492]
[FR Doc No: 2019-10241]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER19-1821-000]

Speedway Solar NC, LLC; Supplemental Notice That Initial Market-
Based Rate Filing Includes Request for Blanket Section 204
Authorization

    This is a supplemental notice in the above-referenced proceeding of
Speedway Solar NC, LLC's application for market-based rate authority,
with an accompanying rate tariff, noting that such application includes
a request for blanket authorization, under 18 CFR part 34, of future
issuances of securities and assumptions of liability.
    Any person desiring to intervene or to protest should file with the
Federal Energy Regulatory Commission, 888 First Street NE, Washington,
DC 20426, in accordance with Rules 211 and 214 of the Commission's
Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone
filing a motion to intervene or protest must serve a copy of that
document on the Applicant.
    Notice is hereby given that the deadline for filing protests with
regard to the applicant's request for blanket authorization, under 18
CFR part 34, of future issuances of securities and assumptions of
liability, is June 3, 2019.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper, using the FERC Online links at http://www.ferc.gov. To facilitate electronic service, persons with internet
access who will eFile a document and/or be listed as a contact for an
intervenor must create and validate an eRegistration account using the
eRegistration link. Select the eFiling link to log on and submit the
intervention or protests.
    Persons unable to file electronically should submit an original and
5 copies of the intervention or protest to the Federal Energy
Regulatory Commission, 888 First Street NE, Washington, DC 20426.
    The filings in the above-referenced proceeding are accessible in
the Commission's eLibrary system by clicking on the appropriate link in
the above list. They are also available for electronic review in the
Commission's Public Reference Room in Washington, DC. There is an
eSubscription link on the website that enables subscribers to receive
email notification when a document is added to a subscribed docket(s).
For assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.

    Dated: May 13, 2019.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2019-10241 Filed 5-16-19; 8:45 am]
 BILLING CODE 6717-01-P


[Federal Register Volume 82, Number 166 (Tuesday, August 29, 2017)]
[Notices]
[Pages 41026-41029]
[FR Doc No: 2017-18377]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0007]

Generic Drug User Fee Rates for Fiscal Year 2018

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as
amended by the Generic Drug User Fee Amendments of 2017 (GDUFA II),
authorizes FDA to assess and collect fees for abbreviated new drug
applications (ANDAs), drug master files (DMFs), generic drug active
pharmaceutical ingredient (API) facilities, finished dosage form (FDF)
facilities, contract manufacturing organization (CMO) facilities, and
generic drug applicant program user fees. In this document the Food and
Drug Administration (FDA or Agency) is announcing fiscal year (FY) 2018
rates for GDUFA fees.

FOR FURTHER INFORMATION CONTACT: David Haas, Office of Financial
Management, Food and Drug Administration, 8455 Colesville Rd., COLE-
14202I, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    Sections 744A and 744B of the FD&C Act (21 U.S.C. 379j-41 and 379j-
42) establish fees associated with human generic drug products. Fees
are assessed on: (1) Certain types of applications for human generic
drug products; (2) certain facilities where APIs and FDFs are produced;
(3) certain DMFs associated with human generic drug products; and (4)
the generic drug applicant program (see section 744B(a)(1)-(5) of the
FD&C Act).
    GDUFA II fees vary greatly from those in GDUFA I because of two
fundamental adjustments to the fee structure:
    (1) The revenue base for GDUFA II is $493.6 million versus $323
million in the final year of GDUFA I--ANDAs are the primary workload
driver of the program. GDUFA I was built on the assumption that FDA
would receive 750 ANDAs per year. Over the first 4 years of GDUFA I,
ANDA receipts have averaged approximately 1,000 per year. To address
the increased workload, FDA hired additional staff and is projected to
spend about $430 million in the final year of GDUFA I. To maintain
FDA's current productivity and implement negotiated improvements, GDUFA
II stipulates that user fees should total $493.6 million annually
adjusted each year for inflation.
    (2) GDUFA II will for the first time rely on annual program fees--
GDUFA II shifts the fee burden somewhat from facility fees.
    For FY 2018, the generic drug fee rates are: ANDA ($171,823), DMF
($47,829), domestic API facility ($45,367), foreign API facility
($60,367), domestic FDF facility ($211,087), foreign FDF facility
($226,087), domestic CMO facility ($70,362), foreign CMO facility
($85,362), large size operation generic drug applicant program
($1,590,792), medium size operation drug applicant program ($636,317),
and small business generic drug applicant program ($159,079). These
fees are effective on October 1, 2017, and will remain in effect
through September 30, 2018.

II. Fee Revenue Amount for FY 2018

    The base revenue amount for FY 2018 is $493,600,000, as set in the
statute (see section 744B(b)(1) of the FD&C Act). GDUFA II directs FDA
to use the yearly revenue amount as a starting point to set the fee
rates for each fee type. For more information about GDUFA II, please
refer to the FDA Web site (http://www.fda.gov/gdufa). The ANDA, DMF,
API facility, FDF facility, CMO facility, and generic drug applicant
program fee (GDUFA Program Fee) calculations for FY 2018 are described
in this document.
    GDUFA II specifies that the $493,600,000 is to be adjusted for
inflation increases for FY 2019 through FY 2022 using two separate
adjustments--one for personnel compensation and benefits (PC&B) and one
for non-PC&B costs (see section 744B(c)(1) of the FD&C Act). Because
the adjustment for inflation does not take effect until FY 2019, FDA
will not adjust the base revenue amount for inflation in FY 2018.

III. ANDA Fee

    Under GDUFA II, the FY 2018 ANDA fee is owed by each applicant that
submits an ANDA on or after October 1, 2017. This fee is due on the
receipt date of the ANDA. Section 744B(b)(2)(B) specifies that the ANDA
fee will make up 33 percent of the $493,600,000, which is $162,888,000.
    To calculate the ANDA fee, FDA estimated the number of full
application equivalents (FAEs) that will be submitted in FY 2018. An
ANDA counts as one FAE; however, 75 percent of the

fee paid for an ANDA shall be refunded according to GDUFA II if (1) the
ANDA is refused for a cause other than failure to pay fees or (2) the
ANDA has been withdrawn prior to receipt (section 744B(a)(2)(D)(i) of
the FD&C Act). Therefore, an ANDA that is considered not to have been
received by FDA due to reasons other than failure to pay fees or
withdrawn prior to receipt counts as one-fourth of an FAE if the
applicant initially paid a full application fee. One hundred percent of
the fee paid for an ANDA shall be refunded if FDA initially receives
the ANDA and subsequent to initial receipt, FDA determines that
exclusivity should have prevented receipt of the ANDA, and thus FDA
determines that the ANDA is no longer received (section
744B(a)(2)(D))(ii) of the FD&C Act).
    FDA utilized data from ANDAs submitted from October 1, 2013, to
April 30, 2017, to estimate the number of new original ANDAs that will
incur filing fees in FY 2018. For FY 2018, the Agency estimates that
approximately 938 new original ANDAs will be submitted and incur filing
fees. Not all of the new original ANDAs will be received by the Agency
and some of those not received will be resubmitted in the same fiscal
year. Therefore, the Agency expects that the FAE count for ANDAs will
be 948 for FY 2018.
    The FY 2018 application fee is estimated by dividing the number of
FAEs that will pay the fee in FY 2018 (948) into the fee revenue amount
to be derived from ANDA application fees in FY 2018 ($162,888,000). The
result, rounded to the nearest dollar, is a fee of $171,823 per ANDA.
    The statute provides that those ANDAs that include information
about the production of active pharmaceutical ingredients other than by
reference to a DMF will pay an additional fee that is based on the
number of such active pharmaceutical ingredients and the number of
facilities proposed to produce those ingredients (see section
744B(a)(3)(F) of the FD&C Act). FDA considers that this additional fee
is unlikely to be assessed often; therefore, FDA has not included
projections concerning the amount of this fee in calculating the fees
for ANDAs.

IV. DMF Fee

    Under GDUFA II, the DMF fee is owed by each person that owns a type
II active pharmaceutical ingredient DMF that is referenced, on or after
October 1, 2012, in a generic drug submission by an initial letter of
authorization. This is a one-time fee for each DMF. This fee is due on
the earlier of the date on which the first generic drug submission is
submitted that references the associated DMF or the date on which the
drug master file holder requests the initial completeness assessment.
Under section 744B(a)(2)(D)(iii) of the FD&C Act, if a DMF has
successfully undergone an initial completeness assessment and the fee
is paid, the DMF will be placed on a publicly available list
documenting DMFs available for reference.
    To calculate the DMF fee, FDA assessed the volume of DMF
submissions over time. The Agency assessed DMFs from October 1, 2015,
to April 30, 2017, and concluded that averaging the number of fee-
paying DMFs provided the most accurate model for predicting fee-paying
DMFs for FY 2018. FDA is estimating 516 fee-paying DMFs for FY 2018.
    The FY 2018 DMF fee is determined by dividing the DMF target
revenue by the estimated number of fee-paying DMFs in FY 2018. Section
744B(b)(2)(A) specifies that the DMF fees will make up five percent of
the $493,600,000, which is $24,680,000. Dividing the DMF revenue amount
($24,680,000) by the estimated fee-paying DMFs (516), and rounding to
the nearest dollar, yields a DMF fee of $47,829 for FY 2018.

V. Foreign Facility Fee Differential

    Under GDUFA II, the fee for a facility located outside the United
States and its territories and possessions shall be $15,000 higher than
the amount of the fee for a facility located in the United States and
its territories and possessions. The basis for this differential is the
extra cost incurred by conducting an inspection outside the United
States and its territories and possessions.

VI. FDF and CMO Facility Fees

    Under GDUFA II, the annual FDF facility fee is owed by each person
who owns an FDF facility that is identified in at least one approved
generic drug submission owned by that person or his affiliates. The CMO
facility fee is owed by each person who owns an FDF facility that is
identified in at least one approved ANDA but is not identified in an
approved ANDA held by the owner of that facility or its affiliates.
These fees are due no later than the first business day on or after
October 1 of each such year. Section 744B(b)(2)(C) of the FD&C Act
specifies that the FDF and CMO facility fee revenue will make up 20
percent of the $493,600,000, which is $98,720,000.
    To calculate the fees, data from FDA's Integrity Services (IS) were
utilized as the primary source of facility information for determining
the denominators of each facility fee type. IS is the master data
steward for all facility information provided in generic drug
submissions received by FDA. A facility's reference status in an
approved generic drug submission is extracted directly from submission
data rather than relying on data from self-identification. This
information provided the number of facilities referenced as FDF
manufacturers in at least one approved generic drug submission. Based
on FDA's IS data for FY 2018, the FDF and CMO facility denominators are
182 FDF domestic, 208 FDF foreign, 71 CMO domestic, and 97 CMO foreign
facilities.
    GDUFA II specifies that the CMO facility fee is to be equal to one-
third the amount of the FDF facility fee. Therefore, to generate the
target collection revenue amount from FDF and CMO facility fees
($98,720,000), FDA must weight a CMO facility as one-third of an FDF
facility. FDA set fees based on the estimate of 182 FDF domestic, 208
FDF foreign, 23.67 CMO domestic (71 multiplied by one-third), and 32.33
CMO foreign facilities (97 multiplied by one-third), which equals 446
total weighted FDF and CMO facilities for FY 2018.
    To calculate the fee for domestic facilities, FDA first determines
the total fee revenue that will result from the foreign facility
differential by subtracting the fee revenue resulting from the foreign
facility fee differential from the target collection revenue amount
($98,720,000) as follows. The foreign facility fee differential revenue
equals the foreign facility fee differential ($15,000) multiplied by
the number of FDF foreign facilities (208) plus the foreign facility
fee differential ($15,000) multiplied by the number of CMO foreign
facilities (97), totaling $4,575,000. This results in foreign fee
differential revenue of $4,575,000 from the total FDF and CMO facility
fee target collection revenue. Subtracting the foreign facility
differential fee revenue ($4,575,000) from the total FDF and CMO
facility target collection revenue ($98,720,000) results in a remaining
facility fee revenue balance of $94,145,000. To determine the domestic
FDF facility fee, FDA divides the $94,145,000 by the total weighted
number of FDF and CMO facilities (446), which results in a domestic FDF
facility fee of $211,087. The foreign FDF facility fee is $15,000 more
than the domestic FDF facility fee, or $226,087.
    CMO fees are as follows. According to GDUFA II, the domestic CMO
fee is calculated as one-third the amount of the domestic FDF facility
fee. Therefore, the domestic CMO fee is $70,362, rounded to the nearest
dollar. The

foreign CMO fee is calculated as the domestic CMO fee plus the foreign
fee differential of $15,000. Therefore, the foreign CMO fee is $85,362.

VII. API Facility Fee

    Under GDUFA II, the annual API facility fee is owed by each person
who owns a facility that is identified in (1) at least one approved
generic drug submission or (2) in a Type II API DMF referenced in at
least one approved generic drug submission. These fees are due no later
than the first business day on or after October 1 of each such year.
Section 744B(b)(2)(D) of the FD&C Act specifies the API facility fee
will make up seven percent of $493,600,000 in fee revenue, which is
$34,552,000.
    To calculate the API facility fee, data from FDA's IS were utilized
as the primary source of facility information for determining the
denominator. As stated above, IS is the master data steward for all
facility information provided in generic drug submissions received by
FDA. A facility's reference status in an approved generic drug
submission is extracted directly from submission data rather than
relying on data from self-identification. This information provided the
number of facilities referenced as API manufacturers in at least one
approved generic drug submission.
    The total number of API facilities identified was 592. Of the total
facilities identified as API facilities, there were 79 domestic
facilities and 513 foreign facilities. The foreign facility
differential is $15,000. To calculate the fee for domestic facilities,
FDA must first subtract the fee revenue that will result from the
foreign facility fee differential. FDA takes the foreign facility
differential ($15,000) and multiplies it by the number of foreign
facilities (513) to determine the total fee revenue that will result
from the foreign facility differential. As a result of that
calculation, the foreign fee differential revenue will make up
$7,695,000 of the total API fee revenue. Subtracting the foreign
facility differential fee revenue ($7,695,000) from the total API
facility target revenue ($34,552,000) results in a remaining balance of
$26,857,000. To determine the domestic API facility fee, we divide the
$26,857,000 by the total number of facilities (592), which gives us a
domestic API facility fee of $45,367. The foreign API facility fee is
$15,000 more than the domestic API facility fee, or $60,367.

VIII. Generic Drug Applicant Program Fee

    Under GDUFA II, if a person and its affiliates own at least one but
not more than five approved ANDAs on October 1, 2017, the person and
its affiliates shall owe a small business GDUFA Program Fee. If a
person and its affiliates own at least 6 but not more than 19 approved
ANDAs, the person and its affiliates shall owe a medium size operation
GDUFA Program Fee. If a person and its affiliates own at least 20
approved ANDAs, the person and its affiliates shall owe a large size
operation GDUFA Program Fee. These fees are due no later than the first
business day on or after October 1 of each such year. Section
744B(b)(2)(E) of the FD&C Act specifies the GDUFA Program Fee will make
up 35 percent of $493,600,000 in fee revenue, which is $172,760,000.
    To determine the appropriate number of applicants for each tier,
the Agency has posted lists of approved ANDAs on the FDA Web site
(http://www.fda.gov/gdufa) and asked applicants on the list to claim
which ANDAs and affiliates belong to the parent company. The original
list of approved ANDAs came from the Agency's Document Archiving,
Reporting, and Regulatory Tracking System (DARRTS), which included all
ANDAs with the status of ``approved'' as of April 30, 2017.
    In determining the appropriate number of approved ANDAs, the Agency
has factored in a number of variables that could affect the collection
of the target revenue: (1) Inactive ANDAs--applicants who have not
submitted an annual report for one or more of their approved
applications within the past 2 years; (2) unclaimed affiliations--a
risk of undercollecting the target revenue if companies do not claim
their ANDAs and their affiliates before the Program Fee is calculated;
and (3) potential portfolio adjustment--applicants may choose to
withdraw some of their approved ANDAs in order to move to a lower tier
and reduce their fee exposure. The list of original approved ANDAs from
the DARRTS database as of April 30, 2017, shows 339 applicants in the
small business tier, 74 applicants in the medium size tier, and 65
applicants in the large size tier. This list also takes into account
all the withdrawals, consolidations, and transfer of ownerships from
industry as of April 30, 2017. Factoring in all the variables for the
first year of GDUFA II, the Agency estimates there will be 258
applicants in the small business tier, 52 applicants in the medium size
tier, and 62 applicants in the large size tier for FY 2018.
    To calculate the GDUFA Program Fee, GDUFA II provides that large
size operation generic drug applicants pay the full fee, medium size
operation applicants pay two-fifths of the full fee, and small business
applicants pay one-tenth of the full fee. To generate the target
collection revenue amount from GDUFA Program Fees ($172,760,000), we
must weigh medium and small tiered applicants as a subset of a large
size operation generic drug applicant. FDA will set fees based on the
weighted estimate of 25.8 applicants in the small business tier (258
multiplied by 10 percent), 20.8 applicants in the medium size tier (52
multiplied by 40 percent), and 62 applicants in the large size tier,
arriving at 108.6 total weighted applicants for FY 2018.
    To generate the large size operation GDUFA Program Fee, FDA divides
the target revenue amount of $172,760,000 by 108.6, which equals
$1,590,792. The medium size operation GDUFA Program Fee is 40 percent
of the full fee ($636,317), and the small business operation GDUFA
Program Fee is 10 percent of the full fee ($159,079).

IX. Fee Schedule for FY 2018

    The fee rates for FY 2018 are set out in table 1.

                    Table 1--Fee Schedule for FY 2018
------------------------------------------------------------------------
                                                              Fee rates
                        Fee category                         for FY 2018
------------------------------------------------------------------------
Applications:
  Abbreviated New Drug Application (ANDA)..................     $171,823
  Drug Master File (DMF)...................................       47,829
Facilities:
  Active Pharmaceutical Ingredient (API)--Domestic.........       45,367
  API--Foreign.............................................       60,367
  Finished Dosage Form (FDF)--Domestic.....................      211,087
  FDF--Foreign.............................................      226,087
  Contract Manufacturing Organization (CMO)--Domestic......       70,362
  CMO--Foreign.............................................       85,362
GDUFA Program:
  Large size operation generic drug applicant..............    1,590,792
  Medium size operation generic drug applicant.............      636,317
  Small business operation generic drug applicant..........      159,079
------------------------------------------------------------------------

X. Fee Payment Options and Procedures

    The new fee rates are effective October 1, 2017. To pay the ANDA,
DMF, API facility, FDF facility, CMO facility, and GDUFA Program Fee,
you must complete a Generic Drug User Fee Cover Sheet, available
through https://www.fda.gov/gdufa and at https://userfees.fda.gov/OA_HTML/gdufaCAcdLogin.jsp, and generate a user fee identification (ID)
number. Payment must be made in U.S. currency drawn on a U.S. bank by
electronic check, check, bank draft, U.S. postal money order, credit
card, or wire transfer. The

preferred payment method is online using electronic check (Automated
Clearing House (ACH) also known as eCheck) or credit card (Discover,
VISA, MasterCard, American Express). Secure electronic payments can be
submitted using the User Fees Payment Portal at https://userfees.fda.gov/pay (Note: Only full payments are accepted. No partial
payments can be made online.) Once you search for your invoice, select
``Pay Now'' to be redirected to Pay.gov. Note that electronic payment
options are based on the balance due. Payment by credit card is
available for balances less than $25,000. If the balance exceeds this
amount, only the ACH option is available. Payments must be made using
U.S. bank accounts as well as U.S. credit cards.
    FDA has partnered with the U.S. Department of the Treasury to
utilize Pay.gov, a web-based payment application, for online electronic
payment. The Pay.gov feature is available on the FDA Web site after
completing the Generic Drug User Fee Cover Sheet and generating the
user fee ID number.
    Please include the user fee ID number on your check, bank draft, or
postal money order and make payable to the order of the Food and Drug
Administration. Your payment can be mailed to: Food and Drug
Administration, P.O. Box 979108, St. Louis, MO 63197-9000. If checks
are to be sent by a courier that requests a street address, the courier
can deliver checks to: U.S. Bank, Attention: Government Lockbox 979108,
1005 Convention Plaza, St. Louis, MO 63101. (Note: This U.S. Bank
address is for courier delivery only. If you have any questions
concerning courier delivery, contact the U.S. Bank at<PHONE_NUMBER>.
This telephone number is only for questions about courier delivery).
Please make sure that the FDA post office box number (P.O. Box 979108)
is written on the check, bank draft, or postal money order.
    If paying by wire transfer, please reference your unique user fee
ID number when completing your transfer. Without your unique user fee
ID number, the payment may not be applied. If the payment amount is not
applied, the invoice amount would be referred to collections. The
originating financial institution may charge a wire transfer fee.
Please ask your financial institution about the wire transfer fee and
include it with your payment to ensure that your fee is fully paid. Use
the following account information when sending a payment by wire
transfer: U.S. Department of Treasury, TREAS NYC, 33 Liberty St., New
York, NY 10045, account number: 75060099, routing number: 021030004,
SWIFT: FRNYUS33, Beneficiary: FDA, 8455 Colesville Rd., 14th Floor,
Silver Spring, MD 20993-0002. If needed, FDA's tax identification
number is 53-0196965.

    Dated: August 24, 2017.
Anna K. Abram,
Deputy Commissioner for Policy, Planning, Legislation, and Analysis.
[FR Doc. 2017-18377 Filed 8-28-17; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 82, Number 243 (Wednesday, December 20, 2017)]
[Rules and Regulations]
[Pages 60318-60320]
[FR Doc No: 2017-27381]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2017-0994]
RIN 1625-AA00

Safety Zone; Spa Creek, Annapolis, MD

AGENCY: Coast Guard, DHS.

ACTION: Temporary final rule.

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

SUMMARY: The Coast Guard is establishing a temporary safety zone for
certain waters of Spa Creek. This action is necessary to provide for
the safety of life on navigable waters during a fireworks display in
Anne Arundel County at Annapolis, MD, on December 31, 2017. This
rulemaking prohibits persons and vessels from entering the safety zone
unless authorized by the Captain of the Port Maryland-National Capital
Region or a designated representative.

DATES: This rule is effective from 11 p.m. on December 31, 2017 through
1 a.m. on January 1, 2018.

ADDRESSES: To view documents mentioned in this preamble as being

available in the docket, go to http://www.regulations.gov, type USCG-
2017-0994 in the ``SEARCH'' box and click ``SEARCH.'' Click on Open
Docket Folder on the line associated with this rule.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email Mr. Ronald Houck, Sector Maryland-National Capital Region
Waterways Management Division, U.S. Coast Guard; telephone 410-576-
2674, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
COTP Captain of the Port
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On August 29, 2017, the City of Annapolis, MD, notified the Coast
Guard that it will be conducting an aerial fireworks display at 11:55
p.m. on December 31, 2017. The fireworks display will be conducted by
Pyrotecnico of New Castle, PA and launched from a barge located in Spa
Creek, in Anne Arundel County at Annapolis, MD. There is no rain date
planned for this fireworks display. In response, on November 21, 2017,
the Coast Guard published a notice of proposed rulemaking (NPRM) titled
``Safety Zone; Spa Creek, Annapolis, MD'' (82 FR 55336). There we
stated why we issued the NPRM, and invited comments on our proposed
regulatory action related to this fireworks display. During the comment
period that ended November 28, 2017, we received no comments.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this rule would be contrary to public interest because immediate action
is needed to respond to the potential safety hazards associated with a
fireworks display from a barge on navigable waters.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 33 U.S.C.
1231. The COTP has determined that potential hazards associated with
the fireworks to be used in this December 31, 2017 display will be a
safety concern for anyone within 133 yards of the fireworks barge. The
purpose of this rule is to ensure safety of vessels and the navigable
waters in the safety zone before, during, and after the scheduled
event.

IV. Discussion of Comments, Changes, and the Rule

    As noted above, we received no comments on our NPRM published
November 21, 2017. There are no changes in the regulatory text of this
rule from the proposed rule in the NPRM.
    This rule establishes a safety zone from 11 p.m. on December 31,
2017 through 1 a.m. on January 1, 2018. The safety zone will cover all
navigable waters of Spa Creek within 133 yards of a fireworks barge in
approximate position latitude 38[deg]58'33.01'' N, longitude
076[deg]28'58.00'' W, located at Annapolis, MD. The duration of the
zone is intended to ensure the safety of vessels and these navigable
waters before, during, and after the scheduled 11:55 p.m. fireworks
display. No vessel or person will be permitted to enter the safety zone
without obtaining permission from the COTP or a designated
representative.

V. Regulatory Analyses

    We developed this rule after considering numerous statutes and
Executive orders related to rulemaking. Below we summarize our analyses
based on a number of these statutes and Executive orders, and we
discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13771 directs agencies to control
regulatory costs through a budgeting process. This rule has not been
designated a ``significant regulatory action,'' under Executive Order
12866. Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB), and pursuant to OMB guidance it is exempt
from the requirements of Executive Order 13771.
    This regulatory action determination is based on the duration,
time-of-year, and time-of-day of the safety zone. Although vessel
traffic will not be able to safely transit around this safety zone, the
impact would be for only 2 hours during the late evening when vessel
traffic in Spa Creek is normally low. Moreover, the Coast Guard will
issue a Broadcast Notice to Mariners via VHF-FM marine channel 16 about
the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard received no comments from the Small Business
Administration on this rulemaking. The Coast Guard certifies under 5
U.S.C. 605(b) that this rule will not have a significant economic
impact on a substantial number of small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Public Law 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

    This rule will not call for a new collection of information under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct

effect on the States, on the relationship between the national
government and the States, or on the distribution of power and
responsibilities among the various levels of government. We have
analyzed this rule under that Order and have determined that it is
consistent with the fundamental federalism principles and preemption
requirements described in Executive Order 13132.
    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this rule has implications for federalism or Indian tribes,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this rule will not result in
such an expenditure, we do discuss the effects of this rule elsewhere
in this preamble.

F. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (42 U.S.C. 4321-4370f), and have determined that
this action is one of a category of actions that do not individually or
cumulatively have a significant effect on the human environment. This
rule involves a safety zone lasting less than two hours that would
prohibit entry within 133 yards of a fireworks barge. It is
categorically excluded from further review under paragraph 34(g) of
Figure 2-1 of the Commandant Instruction. A Record of Environmental
Consideration supporting this determination is available in the docket
where indicated under ADDRESSES.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places or vessels.

List of Subjects in 33 CFR Part 165

    Harbors, Marine safety, Navigation (water), Reporting and
recordkeeping requirements, Security measures, Waterways.

    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 165 as follows:

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

0
1. The authority citation for part 165 continues to read as follows:

    Authority: 33 U.S.C. 1231; 50 U.S.C. 191; 33 CFR 1.05-1, 6.04-1,
6.04-6, and 160.5; and Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T05-0994 to read as follows:

Sec.  165.T05-0994   Safety Zone; Spa Creek, Annapolis, MD.

    (a) Definitions. As used in this section:
    Captain of the Port means the Commander, U.S. Coast Guard Sector
Maryland-National Capital Region.
    Designated representative means any Coast Guard commissioned,
warrant, or petty officer who has been authorized by the Captain of the
Port Maryland-National Capital Region to assist in enforcing the safety
zone described in paragraph (b) of this section.
    (b) Location. The following area is a safety zone: All navigable
waters of Spa Creek, within 133 yards of a fireworks barge in
approximate position latitude 38[deg]58'33.01'' N, longitude
076[deg]28'58.00'' W, located at Annapolis, MD. All coordinates refer
to North American Datum 83 (NAD 1983).
    (c) Regulations. The general safety zone regulations found in
subpart C of this part apply to the safety zone created by this
section.
    (1) All persons are required to comply with the general regulations
governing safety zones found in Sec.  165.23.
    (2) Entry into or remaining in this zone is prohibited unless
authorized by the Captain of the Port (COTP) or designated
representative. All vessels underway within this safety zone at the
time it is implemented are to depart the zone.
    (3) Persons desiring to transit the area of the safety zone must
first obtain authorization from the COTP or designated representative.
To request permission to transit the area, the COTP and or designated
representatives can be contacted at telephone number<PHONE_NUMBER> or on
Marine Band Radio VHF-FM channel 16 (156.8 MHz). The Coast Guard
vessels enforcing this section can be contacted on Marine Band Radio
VHF-FM channel 16 (156.8 MHz). If permission is granted, persons and
vessels must comply with the instructions of the COTP or designated
representative and proceed as directed while within the zone.
    (4) The U.S. Coast Guard may be assisted in the patrol and
enforcement of the safety zone by Federal, State, and local agencies.
    (d) Enforcement period. This section will be enforced from 11 p.m.
on December 31, 2017 through 1 a.m. on January 1, 2018.

    Dated: December 14, 2017.
Michael W. Batchelder,
Commander, U.S. Coast Guard, Acting Captain of the Port Maryland-
National Capital Region.
[FR Doc. 2017-27381 Filed 12-19-17; 8:45 am]
 BILLING CODE 9110-04-P