1 MEMORANDUM DATE: June 21, 2005 SUBJECT: Applicability of DPF on Large Stationary Engines FROM: Tanya Parise, Alpha Gamma Technologies, Inc.

TO: Sims Roy, EPA OAQPS ESD Combustion Group The purpose of this memorandum is to document information related to the application of diesel particulate filters ( DPF) on large stationary compression ignition ( CI) internal combustion engines for the new source performance standards ( NSPS). For the purpose of this memorandum, stationary CI engines greater than 750 horsepower ( HP) with a displacement less than 30 liters per cylinder are considered large engines.

Background The EPA is in the process of developing proposed NSPS for stationary CI internal combustion engines. The proposed standards are primarily modeled on EPA's final rule for control of emissions from nonroad diesel engines, which was published in the Federal Register on June 29, 2004 ( 69 FR 38957). The final rule requires that nonroad diesel engines between 75 and 750 HP meet a particulate matter ( PM) standard of 0.01 grams per brake horsepower hour ( g/ bhp hr) as early as 2011 based on the use of catalyzed DPF. For nonroad diesel engines greater than 750 HP, two categories were established for the final rule to account for significant differences in application: mobile machines and generator sets. For generator sets, the final rule requires that these engines meet a PM standard of 0.02 g/ bhp hr in 2015. The 2015 PM standard for mobile machines was set slightly higher, at 0.03 g/ bhp hr, to account for expectations that engine out emissions from generator sets can be reduced below mobile machine levels due to operation at a single engine speed.

As noted above, the final rule for nonroad diesel engines has a slightly higher PM standard for engines above 750 HP. The PM standard in the proposed rule for nonroad diesel engines was 0.01 g/ bhp hr for all engines above 75 HP. The Engine Manufacturers Association ( EMA) submitted comments to EPA on the proposed rule for nonroad engines indicating that they had concerns with applying DPF technology to large CI engines. The comment from EMA stated the following: 1Summary and Analysis of Comments: Control of Emissions from Nonroad Diesel Engines. United States Environmental Protection Agency, Office of Transportation and Air Quality. EPA420 R 04 008. May 2004.

2 " EMA further added that they do not believe it will be feasible to apply PM filter technology to larger nonroad engines ( above 750 HP). For nonroad engines greater than 750 HP, there are significant challenges associated with the use of multiple parallel PM filters. A large number of parallel filters must be used on the larger engines if on highway technology is to be used directly. A 600 HP highway truck will require at least two parallel filters, while a 3,000 HP engine will require up to five times as many, or 10 parallel PM filters. Each filter must reach sufficient temperatures to burn out the accumulated soot, but the filters will not all run at the same temperatures and only some will reach sufficient temperatures to burn out the soot. Excessive soot accumulation in the coolrunning filter can lead to excessive thermal gradients causing cracks or temperatures so high that the ceramic trap will melt, or causing a pressure drop across the filter. The likelihood of at least partial failures and cracks allowing soot bypassing for large filters made up of smaller segments or of multiple parallel units is high. Therefore, without substantial new technology development, it will not be feasible to apply PM filter technology in these applications."

This comment can be found on page 3 49 of the Summary and Analysis of Comments on the nonroad diesel engines rule. 1 As a result of this and other related comments, the final PM standard for nonroad diesel engines above 750 HP is slightly higher than for smaller engines. As noted by EPA in the response to comments and also in the preamble for the final rule for nonroad diesel engines, the PM emission standard for engines greater than 750 HP was based on a different type of DPF, a wire or fiber mesh depth filter rather than a ceramic wall flow filter, which was the basis for the PM standard for engines between 75 and 750 HP and other smaller engines. The Office of Transportation and Air Quality ( OTAQ) stated in the preamble to the final rule that the application of wall flow filters has not currently been adequately demonstrated on large engines. According to OTAQ, wire or fiber mesh depth filters are less efficient at reducing PM emissions than the ceramic wall flow filters, and are capable of reducing PM by 70 percent or more, whereas ceramic wall flow filters can reduce PM by more than 90 percent. The technology based PM standard for engines between 175 and 750 HP was therefore set at a lower ( more stringent) level, at 0.01 g/ bhp hr. However, OTAQ noted that it would certainly be possible to utilize ceramic based technology for larger engines, but could not guarantee that these filters would be as robust as needed at this time. In addition, OTAQ stated that it believes it may be possible in the time frame of the regulation for conventional DPF to be applied to nonroad diesel engines greater than 750 HP, however, based on comments received, there is too much uncertainty to reach a conclusion at the time of the final rulemaking. Developments 3 may occur and the future application of the more effective PM filter media to engines greater than 750 HP is certainly possible, according to OTAQ.

Due to the concerns raised by EMA, the EPA contacted several DPF system vendors to obtain their input and thoughts on the applicability of DPF to large stationary CI internal combustion engines. The information provided by the vendors is discussed below.

Information from Catalyst Vendors Information from vendors indicated that the application of multiple smaller filters is certainly possible and vendors did not indicate that there are specific concerns with the application of multiple smaller filters to large engines. It appears based on information received that ceramic based filters may also be available for use on large engines. The applications may be few, however, according to vendors, the technology is available.

Mobile vs. Stationary Applications The EPA asked the vendors if the DPF that are applied to stationary engines are different than those applied to mobile ( highway/ nonroad) engines. Engelhard responded to this question by stating that most DPF technologies are very similar if not even the same and that this includes on highway as well as off highway/ stationary engines. Clean Air Systems responded to this question by stating that the filter substrates are the same, but that the catalyst formulation can be different, depending on factors such as the fuel sulfur content, the percent efficiency needed, the regeneration conditions, etc. Miratech's response was that particulate filters for mobile engines are almost all based on a cordierite ceramic material and that stationary engines have used this material as well as porous wall silicon carbide, other ceramic oxides, woven fiberglass and metal fibers woven or formed into filter elements. According to Miratech, these units have traditionally been made in cylinders and the size is limited based on the manufacturing process and material limitations. Miratech stated that based on this, the comments made by EMA are true, but the vendor pointed out that new filters are also made in rectangular blocks that can be stacked and arranged, in a similar but more robust manner due to the pressure, to a traditional catalyst array. The vendor said that the main difference between what Miratech supplies for large engines and the typical ceramic wall flow filters is the material. Miratech uses silicon carbide instead of cordierite. According to Miratech, the properties of silicon carbide makes it more suitable for filter applications than cordierite. The vendor noted the following characteristics of silicon carbide:

° It conducts heat much better than cordierite, which eliminates much of the thermal stress problem, ° It is stronger and will not crack as easily, and ° It can withstand higher temperatures. 4 Miratech indicated to EPA that its partner in Switzerland has sold units up to 2.5 megawatt ( MW) with catalyzed silicon carbide filters and the vendor stated that it is now manufacturing units for 2 MW engines. Finally, Miratech said that designs are currently available for units up to 6.5 MW in size. If the engine exhaust temperature is too cool, a diesel fuel burner can be added to oxidize the soot.

Problems Mentioned by EMA The EPA also asked the vendors if any of the types of problems mentioned in the comment made by EMA would apply when DPF are applied to stationary engines. Johnson Matthey responded that it uses parallel filters on the larger engines. The largest engine this vendor has equipped with DPF was a 3,300 HP engine. Johnson Matthey indicated that this engine is comprised of sixteen filters. The vendor further stated in response to EMA's comment that their Continuously Regenerating Trap ( CRT), a catalyzed diesel particulate filter ( passive DPF), provides a continuous burning of the particulate and that it is not expected that the temperature mentioned in EMA's comment will ever become so high that it will cause the problems noted. Additionally, there will be few occasions when soot will accumulate excessively on hotter running stationary engines, according to the vendor. Miratech stated in response to this comment that with proper housing design and gasketing, several filter blocks can be stacked into a single large housing without having significant leakage around the filters. The vendor indicated that this has been demonstrated by HUG Engineering in Europe. Miratech also stated that the problems listed by EMA are correct but can be addressed with an active regeneration system. In response to this question, Engelhard said that there can be problems with any type of aftertreatment technology if it is not applied correctly. However, with proper sizing and engineering, the problems can be avoided. The representative from Engelhard indicated that he has personally manifolded six soot filters together and that these filters have operated without any problems for more than 5 years. Clean Air Systems responded that stationary engines normally do not have strict space requirements and assuming that load management and the duty cycle are understood, the problems mentioned by EMA do not apply.

Feasibility of meeting nonroad diesel engine PM limits When asked by EPA if vendors believe that the technology is available that would allow large stationary CI internal combustion engines to meet PM limits similar to those for large nonroad diesel engines, all vendors contacted were generally in agreement that those PM levels are achievable for large stationary CI engines. Johnson Matthey stated that it has achieved 85 percent reduction of PM on stationary engines with its CRT system. Miratech was of the opinion that the catalyzed silicon carbide filters ( with or without an active regeneration system) are on the market and available today to meet the PM levels required for nonroad diesel engines. The vendor added that 5 meeting that PM limit will depend on the engine soot production, but that greater than 90 percent reduction is possible. Catalyst vendor Engelhard also agreed that the technology is currently available to meet the PM levels in question, but pointed out that it will depend on what the baseline uncontrolled level of PM is and the test protocol used to measure PM. At such low levels, test equipment and human errors are factors that can affect the level. Finally, Clean Air Systems also agreed that the technology is available today to meet levels similar to the limits for nonroad diesel engines.

Filter Material The EPA also asked vendors to comment on OTAQ's conclusion to base its PM standard for large engines on wire or fiber mesh depth filters as opposed to the conventional ceramic wall flow filters. As previously mentioned, OTAQ believes that wire or fiber mesh depth filters are less efficient at reducing PM, achieving about a 70 percent reduction in PM, versus the conventional filter, which is capable of reducing PM by 90 percent. According to OTAQ, the application of the wall flow filter technology on large nonroad engines has not been adequately demonstrated at this time. Johnson Matthey responded that the number of applications of ceramic wall flow filters on large engines are few, but that wall flow filters appear to be a viable solution. Catalyst vendor Miratech agreed that there are few installations of ceramic wall flow filters on large engines. The vendor further stated that wire mesh filters are not as effective as through wall filters and that it has found that packaging wire mesh filters becomes more difficult for larger engines, as the filters cannot be stacked as easily. Finally, Miratech added that electrical regeneration also becomes difficult due to the number of electrical connections and the amount of energy required become significant. Engelhard indicated that it has successfully applied ceramic wall flow filters on several stationary applications for over 8 years. The applications have been on engines ranging in size from 40 kilowatt to 2 MW. Engelhard noted however that there may be applications where it would decline to supply such a filter due to incompatibility and the wire or fiber mesh depth filters would work.

Largest Engines with DPF The EPA also asked several major control technology vendors for information regarding the application of DPF to stationary engines in order to determine what the largest engines with DPF are. The catalyst vendor Johnson Matthey indicated to EPA that its largest DPF application was on a 3,300 HP engine. Miratech Corporation, another well known control technology manufacturer, indicated to EPA that it works alongside HUG Engineering of Switzerland for its filter supply and that the largest filter that it has supplied was for an engine approximately 4,000 HP in size. Johnson Matthey further noted that in the United States, it is currently supplying 42 filters for the Long Island Power Authority on stationary Cummins engines about 3,200 HP in size. This project will be completed in the fall of 2004. When asked what the largest size stationary engine Engelhard ( another major catalyst vendor) has equipped with DPF, Engelhard 6 responded that it has retrofitted Engelhard filters on approximately 2,800 HP engines and indicated that it had done quite a few of these installations for Caterpillar and Cummins ( engine manufacturers). Finally, EPA consulted Clean Air Systems to determine the largest stationary engine it had equipped with DPF. Clean Air Systems replied that it has done many 2 MW engines and those are the largest, but that it can install DPF on engines larger than that. Based on information received from several major DPF manufacturers, it appears DPF can be and has been applied to large stationary engines well above 750 HP.

Finally, during a recent meeting EPA had with members of the Institute of Clean Air Companies, control technology vendors indicated that ceramic wall flow filter technology is currently available and can be applied to large stationary engines. A representative from Johnson Matthey indicated that Johnson Matthey has been working on applications of DPF on large engines and 85 percent PM reductions has been achieved.

California ATCM In addition to consulting with vendors of DPF systems, EPA also reviewed information gathered by the California Air Resources Board ( CARB) in support of its airborne toxic control measure ( ATCM) for stationary CI engines, which became operative on December 8, 2004. The standards require stationary new and in use prime CI engines greater than 50 HP to meet a diesel PM limit of 0.01 g/ bhp hr. The Board believes the 0.01 g/ bhp hr is technologically feasible because results from a demonstration program conducted by CARB in order to evaluate the feasibility of several PM control technology options showed that two stationary diesel engines were able to achieve a diesel PM emission rate of equal to or less than 0.01 g/ bhp hr following the application of DPF technologies. In addition, emissions test data from Clean Air Systems' PERMIT technology, a passive DPF, has shown that the technology is capable of reducing PM emissions by 85 percent or more, which has yielded diesel PM emission rates below 0.01 g/ bhp hr. The PERMIT technology from Clean Air Systems has been verified by CARB for application to engines and is verified to obtain 85 percent PM reduction on several engine models. The ATCM does not contain any size categories for engines greater than 50 HP, but instead has the same requirements for PM for all new and inuse prime CI engines and does not make a distinction of large engines. It is assumed DPF will be capable of reducing PM emissions from any engine by 85 percent. 2California Air Resources Board Staff Report: Initial Statement of Reasons for Proposed Rulemaking. Airborne Toxic Control Measure for Stationary Compression Ignition Engines. Stationary Source Division, Emissions Assessment Branch. September 2003.

3Note that information received from Johnson Matthey indicated that the CRT is not a catalyzed filter but contains a catalyst in front of a particulate filter. The vendor indicated that the catalyst produces more NO 2 in the exhaust which enables regeneration ( oxidation) of the particulate at a lower temperature. Johnson Matthey indicated that it finds this technology to be much more effective than a catalyzed filter.

7 The Staff Report published by CARB for the proposed rulemaking for the ATCM for stationary CI engines2 documented several installations of catalyzed DPF on stationary CI engines in California. The stationary CI engines ranged in size from 67 to 2,848 HP, with the majority of stationary CI engine DPF applications greater than 750 HP. Testing conducted on many of the stationary CI engines with catalyzed DPF indicated that PM emissions were frequently reduced by 85 percent.

In addition to information CARB obtained from in use stationary CI engines with PM control, it also conducted a demonstration program, as previously mentioned, to further investigate the effectiveness of PM control technologies. Among the control technologies tested in the demonstration program were the following particulate filters:

° Lubrizol Engine Control Systems' Sequentially Regenerated Combifilter  a triple bank silicon carbide particulate filter with online filter regeneration by electrical heating ( active DPF), and ° Johnson Matthey's CRT. 3 The demonstration program showed that the control efficiencies for both active and passive particulate filters were greater than 85 percent when applied to stationary engines burning ultra low sulfur diesel and PM levels of 0.01 g/ bhp hr were achieved.

Conclusion Based on the information summarized in this memorandum obtained from OTAQ, CARB, and several control technology vendors, EPA believes that it is feasible to apply DPF to large stationary CI internal combustion engines and obtain similar levels of PM reduction as those required for nonroad diesel engines. Consistent with statements made by OTAQ, the EPA does not exclude the possibility that conventional DPF could be used on large stationary CI engines and vendors have indicated that the technology is available to meet the PM levels promulgated for nonroad diesel engines ( and potentially also lower PM levels). However, the EPA believes it is appropriate to remain consistent with decisions made by OTAQ for nonroad diesel engines to ensure that the proposed PM standards for stationary CI engines are achievable by large engines. For this reason, the EPA believes that the PM emission standards 8 promulgated for large nonroad diesel engines are appropriate for large stationary CI engines, and is therefore proposing that large stationary CI engines meet the nonroad diesel engine PM standards


[Federal Register Volume 76, Number 195 (Friday, October 7, 2011)]
[Notices]
[Page 62495]
[FR Doc No: 2011-25906]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Notice of Extension of Public Scoping Comment Period for the Air
Tour Management Plan Program at Golden Gate National Recreation Area,
San Francisco Maritime National Historical Park and Point Reyes
National Seashore

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice of extension of public scoping comment period for the
Air Tour Management Plan Program at Golden Gate National Recreation
Area, San Francisco Maritime National Historical Park and Point Reyes
National Seashore.

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    This notice extends the public scoping comment period for the Air
Tour Management Plan (ATMP) for Golden Gate National Recreation Area
(GGNRA) and Point Reyes National Seashore (the Seashore) that was
published in the Federal Register on July 28, 2011 (76 FR 45312). The
original date that the comment period would end was September 28, 2011.
During that time the National Park Service (NPS) Planning, Environment
and Public Comment Web site (PEPC) experienced some technical
complications that made it difficult for everyone's comments to be
captured on the system. That public scoping comment period date will
now be extended until October 21, 2011.
    The FAA, with NPS as a cooperating agency, has initiated
development of ATMPs for GGNRA and the Seashore. The ATMP for GGNRA
will include Muir Woods National Monument and Fort Point National
Historic Site, both directly managed by GGNRA, and the San Francisco
Maritime National Historical Park (SF Maritime NHP), an independently
managed national park unit adjacent to GGNRA.
    The ATMPs are being developed pursuant to the National Parks Air
Tour Management Act (NPATMA) of 2000 (Pub. L. 106-181) and it's
implementing regulations (14 Code of Federal Regulation [CFR] part 136,
Subpart B, National Parks Air Tour Management). Per section
40128(b)(1)(B) of NPATMA, the objective of an ATMP shall be to develop
acceptable and effective measures to mitigate or prevent significant
adverse impacts, if any, of commercial air tour operations upon the
natural and cultural resources, visitor experiences and tribal lands
within or abutting GGNRA and the Seashore. It should be noted that an
ATMP has no authorization over other non-air-tour operations such as
military and general aviation. In compliance with the National
Environmental Policy Act of 1969 (NEPA) and FAA Order 1050.1E, an
Environmental Assessment (EA) is being prepared.
    The FAA has granted Interim Operating Authority (IOA) to two
commercial air tour operators to conduct air tours over GGNRA, SF
Maritime NHP, and the Seashore.
    The FAA and NPS are now inviting the public, agencies, tribes, and
other interested parties to provide comments, suggestions, and input on
the scope of issues and range of alternatives to be addressed in the
environmental process.

DATES: By this notice, the FAA is extending the public scoping comment
period for the EA for the individual ATMPs at GGNRA and SF Maritime
NHP, and the Seashore. The original date that the comment period would
end was September 28, 2011. That date will now be extended until
October 21, 2011.

FOR FURTHER INFORMATION CONTACT: Keith Lusk--Mailing address: P.O. Box
92007, Los Angeles, California 90009-2007. Telephone:<PHONE_NUMBER>.
Street address: 15000 Aviation Boulevard, Lawndale, California 90261.
Written comments on the scope of the EA should be submitted
electronically via the electronic public comment form on the NPS
Planning, Environment and Public Comment Web site at: http://parkplanning.nps.gov/BayArea_ATMP or sent to the mailing address
above.

SUPPLEMENTARY INFORMATION: A public scoping packet that describes the
project in greater detail is available at:
     http://parkplanning.nps.gov/BayArea_ATMP.
     http://www.faa.gov/about/office_org/headquarters_offices/arc/programs/air_tour_management_plan/.
    Notice Regarding FOIA: Individuals may request that their name and/
or address be withheld from public disclosure. If you wish to do this,
you must state this prominently at the beginning of your comment.
Commentators using the Web site can make such a request by checking the
box ``keep my contact information private.'' Such requests will be
honored to the extent allowable by law, but you should be aware that
pursuant to the Freedom of Information Act, your name and address may
be disclosed. We will make all submissions from organizations,
businesses, and from individuals identifying themselves as
representatives or officials of organizations or businesses available
for public inspection in their entirety.

    Issued in Hawthorne, CA on September 29, 2011.
Larry Tonish,
Program Manager, Special Programs Staff, Western-Pacific Region.
[FR Doc. 2011-25906 Filed 10-6-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 82, Number 204 (Tuesday, October 24, 2017)]
[Rules and Regulations]
[Pages 49102-49104]
[FR Doc No: 2017-22995]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 866

[Docket No. FDA-2017-N-5651]

Medical Devices; Immunology and Microbiology Devices;
Classification of the Zinc Transporter 8 Autoantibody Immunological
Test System

AGENCY: Food and Drug Administration, HHS.

ACTION: Final order.

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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the zinc transporter 8 autoantibody immunological test system into
class II (special controls). The special controls that apply to the
device type are identified in this order and will be part of the
codified language for the zinc transporter 8 autoantibody immunological
test system's classification. We are taking this action because we have
determined that classifying the device into class II (special controls)
will provide a reasonable assurance of safety and effectiveness of the
device. We believe this action will also enhance patients' access to
beneficial innovative devices, in part by reducing regulatory burdens.

DATES: This order is effective October 24, 2017. The classification was
applicable on August 20, 2014.

FOR FURTHER INFORMATION CONTACT: Steven Tjoe, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 4550, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    Upon request, FDA has classified the zinc transporter 8
autoantibody immunological test system as class II (special controls),
which we have determined will provide a reasonable assurance of safety
and effectiveness. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into a lower device class than
the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law
and without any action by FDA, regardless of the level of risk posed by
the new device. Any device that was not in commercial distribution
before May 28, 1976, is automatically classified as, and remains
within, class III and requires premarket approval unless and until FDA
takes an action to classify or reclassify the device (see 21 U.S.C.
360c(f)(1)). We refer to these devices as ``postamendments devices''
because they were not in commercial distribution prior to the date of
enactment of the Medical Device Amendments of 1976, which amended the
Federal Food, Drug, and Cosmetic Act (the FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to
classify or reclassify a device into class I or II. We may issue an
order finding a new device to be substantially equivalent under section
513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a predicate device that
does not require premarket approval. We determine whether a new device
is substantially equivalent to a predicate by means of the procedures
for premarket notification under section 510(k) of the FD&C Act and
part 807 (21 U.S.C. 360(k) and 21 CFR part 807, respectively).
    FDA may also classify a device through ``De Novo'' classification,
a common name for the process authorized under section 513(f)(2) of the
FD&C Act. Section 207 of the Food and Drug Administration Modernization
Act of 1997 established the first procedure for De Novo classification
(Pub. L. 105-115). Section 607 of the Food and Drug Administration
Safety and Innovation Act modified the De Novo application process by
adding a second procedure (Pub. L. 112-144). A device sponsor may
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device
that has not previously been classified. After receiving an order from
FDA classifying the device into class III under section 513(f)(1) of
the FD&C Act, the person then requests a classification under section
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k)
and then a request for classification, if the person determines that
there is no legally marketed device upon which to base a determination
of substantial equivalence, that person requests a classification under
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required
to classify the device by written order within 120 days. The
classification will be according to the criteria under section
513(a)(1) of the FD&C Act (21 U.S.C. 360c(a)(1)). Although the device
was automatically placed within class III, the De Novo classification
is considered to be the initial classification of the device.
    We believe this De Novo classification will enhance patients'
access to beneficial innovation, in part by reducing regulatory
burdens. When FDA classifies a device into class I or II via the De
Novo process, the device can serve as a predicate for future devices of
that type, including for 510(k)s (see 21 U.S.C. 360c(f)(2)(B)(i)). As a
result, other device sponsors do not have to submit a De Novo request
or premarket approval application (PMA) in order to market a
substantially equivalent device (see 21 U.S.C. 360c(i), defining
``substantial equivalence''). Instead, sponsors can use the less-
burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    For this device, FDA issued an order on May 21, 2014, finding the
KRONUS Zinc Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay not
substantially equivalent to a predicate not subject to PMA. Thus, the
device remained in class III in accordance with section 513(f)(1) of
the FD&C Act when we issued the order.
    On June 16, 2014, KRONUS Market Development Associates, Inc.,
submitted a request for De Novo classification of the KRONUS Zinc
Transporter 8 Autoantibody (ZnT8Ab) ELISA Assay. FDA reviewed the
request in order to classify the device under the criteria for
classification set forth in section 513(a)(1) of the FD&C Act. We
classify devices into class II if general controls by themselves are
insufficient to provide reasonable assurance of safety and
effectiveness, but there is sufficient information to establish special
controls that, in combination with the general controls, provide
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the
information submitted in the request, we determined that the device can
be classified into class II with the establishment of special controls.
FDA has determined that these special controls, in addition to general
controls, will provide reasonable assurance of the safety and
effectiveness of the device.

    Therefore, on August 20, 2014, FDA issued an order to the requestor
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 866.5670. We have named
the generic type of device zinc transporter 8 autoantibody
immunological test system, and it is identified as a device that
consists of reagents used to measure, by immunochemical techniques, the
autoantibodies in human serum samples that react with Zinc Transporter
8 (ZnT8). The measurements aid in the diagnosis of Type 1 diabetes
mellitus (autoimmune mediated diabetes) in conjunction with other
clinical and laboratory findings.
    FDA has identified the following risks to health associated
specifically with this type of device and the measures required to
mitigate these risks in table 1.

Table 1--Zinc Transporter 8 Autoantibody Immunological Test System Risks
                         and Mitigation Measures
------------------------------------------------------------------------
                                            Mitigation measures/21 CFR
            Identified risks                         section
------------------------------------------------------------------------
Inaccurate test results that provide     Special controls (1), (2), and
 false positive or false negative         (3) (21 CFR 866.5670(b)(1), 21
 results can lead to improper patient     CFR 866.5670(b)(2), and 21 CFR
 management.                              866.5670(b)(3)).
Failure to correctly interpret test      Special controls (1)(iii), (2),
 results can lead to false positive or    and (3) (21 CFR
 false negative results.                  866.5670(b)(1)(iii), 21 CFR
                                          866.5670(b)(2), and 21 CFR
                                          866.5670(b)(3)).
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the
general controls, address these risks to health and provide reasonable
assurance of safety and effectiveness. In order for a device to fall
within this classification, and thus avoid automatic classification in
class III, it would have to comply with the special controls named in
this final order. The necessary special controls appear in the
regulation codified by this order. This device is subject to premarket
notification requirements under section 510(k).

III. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to
previously approved collections of information found in other FDA
regulations. These collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
part 807, subpart E, regarding premarket notification submissions have
been approved under OMB control number 0910-0120, the collections of
information in 21 CFR part 820 have been approved under OMB control
number 0910-0073, and the collections of information in 21 CFR parts
801 and 809, regarding labeling have been approved under OMB control
number 0910-0485.

List of Subjects in 21 CFR Part 866

    Biologics, Laboratories, Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR part
866 is amended as follows:

PART 866--IMMUNOLOGY AND MICROBIOLOGY DEVICES

0
1. The authority citation for part 866 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360l, 371.

0
2. Add Sec.  866.5670 to subpart F to read as follows:

Sec.  866.5670  Zinc transporter 8 autoantibody immunological test
system.

    (a) Identification. A zinc transporter 8 autoantibody immunological
test system is a device that consists of reagents used to measure, by
immunochemical techniques, the autoantibodies in human serum samples
that react with Zinc Transporter 8 (ZnT8). The measurements aid in the
diagnosis of Type 1 diabetes mellitus (autoimmune mediated diabetes) in
conjunction with other clinical and laboratory findings.
    (b) Classification. Class II (special controls). The special
controls for this device are:
    (1) Premarket notification submissions must include the following
information:
    (i) A detailed description of the device that includes:
    (A) A detailed description of all components in the test system,
including a description of the assay components in the kit and all
required ancillary reagents;
    (B) A detailed description of instrumentation and equipment, and
illustrations or photographs of non-standard equipment or methods if
applicable;
    (C) Detailed documentation of the device software, including, but
not limited to, standalone software applications and hardware-based
devices that incorporate software where applicable;
    (D) A detailed description of appropriate internal and external
quality controls that are recommended or provided. The description must
identify those control elements that are incorporated into the
recommended testing procedures;
    (E) Detailed specifications for sample collection, processing, and
storage;
    (F) A detailed description of methodology and assay procedure; and
    (G) Detailed specification of the criteria for test results
interpretation and reporting.
    (ii) Information that demonstrates the performance characteristics
of the device, including:
    (A) Device precision/reproducibility data generated from within-
run, between-run, between-day, between-lot, between-operator, between-
instruments, between-site, and total precision for multiple
nonconsecutive days as applicable. A well characterized panel of
patient samples or pools from the intended use population that covers
the device measuring range must be used;
    (B) Device linearity data generated from patient samples covering
the assay measuring range if applicable;
    (C) Information on traceability to a reference material and
description of value assignment of calibrators and controls if
applicable;
    (D) Device analytical sensitivity data, including limit of blank,
limit of detection and limit of quantitation if applicable;
    (E) Device analytical specificity data, including interference by
endogenous and exogenous substances, as well as cross-reactivity with
samples derived from patients with other autoimmune diseases or
conditions;
    (F) Device instrument carryover data when applicable;
    (G) Device stability data including real-time stability under
various storage times and temperatures;

    (H) Specimen stability data, including stability under various
storage times, temperatures, freeze-thaw, and transport conditions
where appropriate;
    (I) Method comparison data generated by comparison of the results
obtained with the device to those obtained with a legally marketed
predicate device with similar indication of use. Patient samples from
the intended use population covering the device measuring range must be
used;
    (J) Specimen matrix comparison data if more than one specimen type
or anticoagulant can be tested with the device. Samples used for
comparison must be from patient samples covering the device measuring
range;
    (K) A description of how the assay cut-off (the medical decision
point between positive and negative) was established and validated as
well as supporting data;
    (L) Clinical performance must be established by comparing data
generated by testing samples from the intended use population and the
differential diagnosis groups with the device to the clinical
diagnostic standard. The diagnosis of Type 1 diabetes mellitus must be
based on clinical history, physical examination, and laboratory tests,
such as one or more pancreatic or insulin autoantibody test. Because
the intended use population for Type 1 diabetes mellitus includes
subjects less than 18 years old, samples from representative numbers of
these subjects must be included. Representative numbers of samples from
all age strata must also be included. The differential diagnosis groups
must include, but not be limited to the following: Type 2 diabetes
mellitus; metabolic syndrome; latent autoimmune diabetes in adults;
other autoimmune diseases such as celiac disease (without a concomitant
diagnosis of Type 1 diabetes mellitus), systemic lupus erythematosus,
rheumatoid arthritis, and Hashimoto's thyroiditis; infection; renal
disease; and testicular cancer. Diseases for the differential groups
must be based on established diagnostic criteria and clinical
evaluation. For all samples, the diagnostic clinical criteria and the
demographic information must be collected and provided. The clinical
validation results must demonstrate clinical sensitivity and clinical
specificity for the test values based on the presence or absence of
Type 1 diabetes mellitus. The data must be summarized in tabular format
comparing the interpretation of results to the disease status; and
    (M) Expected/reference values generated by testing an adequate
number of samples from apparently healthy normal individuals.
    (iii) Identification of risk mitigation elements used by the
device, including description of all additional procedures, methods,
and practices incorporated into the directions for use that mitigate
risks associated with testing.
    (2) Your 21 CFR 809.10(a) compliant label and 21 CFR 809.10(b)
compliant labeling must include warnings relevant to the assay
including:
    (i) A warning statement that reads, ``The device is for use by
laboratory professionals in a clinical laboratory setting'';
    (ii) A warning statement that reads, ``The test is not a stand-
alone test but an adjunct to other clinical information. A diagnosis of
Type 1 diabetes mellitus should not be made on a single test result.
The clinical symptoms, results on physical examination, and laboratory
tests (e.g., serological tests), when appropriate, should always be
taken into account when considering the diagnosis of Type 1 diabetes
mellitus and Type 2 diabetes mellitus'';
    (iii) A warning statement that reads, ``Absence of Zinc T8
autoantibody does not rule out a diagnosis of Type 1 diabetes
mellitus''; and
    (iv) A warning statement that reads, ``The assay has not been
demonstrated to be effective for monitoring the stage of disease or its
response to treatment.''
    (3) Your 21 CFR 809.10(b) compliant labeling must include a
description of the protocol and performance studies performed in
accordance with paragraph (b)(1)(ii) of this section and a summary of
the results.

    Dated: October 18, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22995 Filed 10-23-17; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 80, Number 127 (Thursday, July 2, 2015)]
[Notices]
[Page 38265]
[FR Doc No: 2015-16393]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-26367]

Medical Review Board (MRB) Meeting: Public Meeting

AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT.

ACTION: Announcement of advisory committee public meeting.

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

SUMMARY: FMCSA announces a meeting of its Medical Review Board (MRB) on
Tuesday and Wednesday, July 21-22, 2015. The MRB will identify factors
the Agency should consider with regard to regulatory actions concerning
Type I diabetes and vision standards for interstate commercial motor
vehicle (CMV) drivers. This follows the Agency's issuance of a Notice
of Proposed Rulemaking (NPRM) on May 4, 2015, that would permit drivers
with stable, well-controlled insulin-treated diabetes mellitus (ITDM)
to be qualified to operate CMVs in interstate commerce. The MRB
discussions would precede the Agency's consideration of a rulemaking
concerning the vision standard. Meetings are open to the public for
their entirety, and the public will be allowed to comment during the
proceedings.

DATES: The meeting will be held on Tuesday and Wednesday, July 21-22,
2015, from 9 a.m. to 4:30 p.m., Eastern Daylight Time (E.T.), at the
FMCSA National Training Center, 1310 N. Courthouse Road, Arlington, VA.
Copies of the task statement and an agenda for the entire meeting will
be made available in advance of the meeting at http://mrb.fmcsa.dot.gov.

FOR FURTHER INFORMATION CONTACT: Ms. Shannon L. Watson, Senior Advisor
to the Associate Administrator for Policy, Federal Motor Carrier Safety
Administration, U.S. Department of Transportation, 1200 New Jersey
Avenue SE., Washington, DC 20590,<PHONE_NUMBER><EMAIL_ADDRESS>
Services for Individuals With Disabilities

    For information on facilities or services for individuals with
disabilities or to request special assistance at the meeting, contact
Eran Segev at<PHONE_NUMBER><EMAIL_ADDRESS>by Wednesday, July
15.

SUPPLEMENTARY INFORMATION:

I. Background

    The MRB is composed of five medical experts who each serve 2-year
terms. Section 4116 of SAFETEA-LU requires the Secretary of
Transportation, with the advice of the MRB and the chief medical
examiner, to establish, review, and revise ``medical standards for
operators of commercial motor vehicles that will ensure that the
physical condition of operators of commercial motor vehicles is
adequate to enable them to operate the vehicles safely.'' The MRB
operates in accordance with FACA under the terms of its charter, filed
November 25, 2013.

II. Meeting Participation

    Oral comments from the public will be heard during the meeting,
subject to the discretion of the Chairman. Members of the public may
submit written comments on the topics to be considered during the
meeting by Wednesday, July 15, to Federal Docket Management System
(FDMC) Docket Number FMCSA-2008-0362 for the MRB using any of the
following methods:
     Federal eRulemaking Portal: Go to http://www.regulations.gov. Follow the online instructions for submitting
comments.
     Fax:<PHONE_NUMBER>.
     Mail: Docket Management Facility; U.S. Department of
Transportation, 1200 New Jersey Avenue SE., West Building, Room W12-
140, Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, 1200 New
Jersey Avenue SE., Room W12-140, Washington, DC, between 9 a.m. and 5
p.m., E.T. Monday through Friday, except Federal holidays.

    Issued on: June 29, 2015.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2015-16393 Filed 7-1-15; 8:45 am]
 BILLING CODE 4910-EX-P


Page 1 of 5 Addendum to Dicofol RED Purpose of Addendum The United States Environmental Protection Agency ( hereafter referred to as EPA or Agency) is issuing this document as an addendum to the 1998 Reregistration Eligibility Decision ( RED) for dicofol and as a revision to the Occupational Exposure Assessment, dated November 19, 1999. At the time the RED was signed, the Agency was concerned with occupational exposure and risk. At that time, most short term and all intermediate term exposure scenarios for mixers, loaders, applicators, and field workers were of concern to the Agency, even when using personal protective equipment and engineering controls. However, the Agency believed that the default assumptions that were used to arrive at these conclusions led to an overestimate of risk ( e. g.; the default assumption of 100% dermal absorption). To improve the estimation of risk, the registrant agreed to submit a dermal toxicity study and a dislodgeable foliar residue study. This information was submitted to the Agency, and a revised occupational risk assessment was conducted. After completing the revised risk assessment, post application occupational exposure was still a concern for most crops. Recently, all dicofol occupational use scenarios have been re evaluated and the Agency is issuing this document to address concerns that were initially highlighted in the RED.

Dicofol Overview Dicofol is an organochlorine miticide which is registered for use on beans ( dry, lima, and green), cotton, hops, mint, peppers, tomatoes, citrus, pecans, walnuts, tree nuts, cucurbits, grapes, pomefruit, stone fruit, strawberries, melons, and non residential lawns and ornamentals. Special Local Need registrations are currently active for use on alfalfa and cane berries. At the time the RED was signed, dicofol was an important component of mite control programs. Today there are many alternatives to dicofol that are equally efficacious and cost effective, resulting in an overall decrease in dicofol use.

According to EPA resources, usage on three major use sites ( cotton, grapefruit, and oranges) has significantly declined since 1998. For example, publicly available U. S. Department of Agriculture National Agricultural Statistic Service ( NASS) data show a 75% decrease in dicofol use on cotton ( approximately 400,000 pounds active ingredient in 1998 and approximately 100,000 pounds active ingredient in 2003). The 1998 RED cites that dicofol was used on approximately 22% of grapefruit grown in the U. S. ( estimated maximum) at that time. Currently, the Agency's resources show that on a national scale, approximately 7% of grapefruit is treated with dicofol and annual pounds of active ingredient applied have decreased 94% since 1995. Additionally, the 1998 RED cites that dicofol was used on approximately 13% of oranges grown in the U. S. ( estimated maximum) at that time. Currently, the Agency's resources show that less than 5% of oranges grown in the U. S. are treated with dicofol and annual pounds of active ingredient applied have decreased 97% since 1995. Page 2 of 5 Registered end use products are formulated as emulsifiable concentrates or wettable powders. These formulations may be applied as concentrates or dilute sprays using aircraft or ground spray equipment. Three of the twelve currently registered products were registered after the RED was signed, but these must also be modified to follow the mitigation set forth in the RED and Addendum to the RED. In addition, compliance with this mitigation is also required for three Special Local Need ( SLN) products.

Work the Agency has Done Since the Completion of the RED Since the issuance of the RED, the Agency received and evaluated a 90 day dog dermal study ( MRID 44720501) and a chemical specific dislodgeable foliar residue study ( MRID 45290602). The review of the 90 day dermal study resulted in the revision of selected endpoints. Changes and discussion of changes are presented in the Revised Report of the Hazard Identification Assessment Review Committee, dated September 9, 1999. The Agency used the newly submitted information and re evaluated postapplication occupational exposures. Most post application exposure scenarios continued to be of concern to the Agency.

The Agency has concluded that revised, longer REIs are needed. For crops on which dicofol is used, workers may be required to work in fields for extended periods of time. The Agency is concerned that certain activities, including hand harvesting and moving from one treated field to the next, will potentially put workers at risk. Crops in this category include citrus ( grapefruit, oranges, nectarines, and tangelos), stone fruits ( apricots, nectarines, and peaches), tree nuts, mint, tomatoes, peppers, cucurbits, pomefruit ( apples and pears), grapes, beans, strawberries, cane berries, and nonresidential lawns and ornamentals. However, the Agency believes increasing REIs for these crops will not likely impact production of these crops because adequate alternatives are available and dicofol applications can be made when field activities are not required.

In order to determine the economic and biological impact of imposing longer REIs, EPA's Office of Pesticide's Biological and Economic Analysis Division ( BEAD) provided benefit assessments for selected crops. BEAD examined crops/ crop groups that have 5% or more percent crop treated with dicofol, on a national basis. The crops that were included in the assessment are: citrus ( grapefruit, oranges, and tangelos), stone fruits ( apricots, nectarines, and peaches), and tree nuts ( pecans). The complete results of the benefits assessments are provided with this addendum as supporting documents.

At present, all dicofol labels require REIs of 12 hours. However, the Agency believes that typical field activities will require workers to work in fields for extended periods of time and thus result in exposures exceeding levels of conern when an REI of 12 hours is observed. Therefore, the Agency is increasing REIs for most crops in order to protect post application occupational workers. For cotton and alfalfa, which are largely mechanically harvested, the Agency believes that post application exposures will be Page 3 of 5 minimal, eliminating a major source of potential exposure. Therefore, the Agency has concluded that the re entry intervals of 12 hours can remain the same for cotton and alfalfa.

Revised Re entry Intervals The Agency has determined that dicofol labels need to be revised to incorporate longer REIs for the following crops: citrus, pecans, walnuts, stone fruit, cucurbits, pomefruit, beans, grapes, non residential turf and ornamentals, tomatoes, peppers, strawberries, cane berries, mint, and hops. The Agency believes that there is the potential that post application field activities will expose occupational workers for an extended period of time to dicofol, a period of time that could result in adverse health effects. To determine the biological and economical impact of increasing REIs for crops that have more than 5% crop treated nationally, the Agency conducted benefits assessments. As discussed previously, these crops include citrus, pecans, and stone fruit. The Agency has received information from USDA to help inform this decision. A brief summary of rationale used by the Agency for these crops is included below and complete assessments are included as supporting information.

To protect workers, the Agency will require that new labels include the following REIs for the specified crops:

  Citrus ( oranges, tangelos, tangerines, grapefruit)  87 days   Stone fruit ( apricots, peaches, nectarines)  33 days   Pecans/ Walnuts/ Tree Nuts  49 days ( applications must be made before shuck split)   Cucurbits  21 days   Pomefruit ( apples, pears)  35 days   Beans  33 days   Grapes  39 days   Sod/ Turf ( surrogate for non residential turf)  29 days   Tomatoes/ Peppers  25 days   Strawberries ( and Cane Berries) 31 days   Mint  32 days   Hops  29 days Citrus Dicofol is applied to citrus to control a complex of mites including spider mites and rust mites. Currently, dicofol is not significantly used on oranges, tangelos, or tangerines. In Texas approximately 25% of grapefruit are treated with dicofol.

Dicofol labels currently specify a 12 hour REI for citrus. The Agency is concerned that an REI of 12 hours is not restrictive enough, and that residue levels of dicofol may be present that could potentially harm workers who are participating in field activities. Therefore, a new REI of 87 days will be established for citrus. Page 4 of 5 The Agency believes that there will not likely be a negative impact on grapefruit production in Texas if REIs are extended, as dicofol will be shifted in the rotational spray program to a period where field activities will not be restricted. In addition, even with a longer REI, dicofol application would still be an option during the non harvest period ( June September). Further, numerous alternative miticides are available which are both efficacious and cost effective. Alternatives include, but are not limited to: abamectin, formetanate hydrochloride, diflubenzuron, pyridaben, propargite, and fenbutatin oxide. These alternatives have REIs that range from 12 to 48 hours. A more complete list of alternative miticides, as well as a discussion of alternatives, is included in the " Benefits Assessment for Dicofol on Citrus: Oranges, Grapefruit, Tangerines, and Tangelos", dated April 13, 2005.

Stone Fruit Dicofol is applied to stone fruits to control several types of mites, including webspinning mites. Over the past four years, national use of dicofol on stone fruit has declined.

Dicofol labels currently specify a 12 hour REI for stone fruit. The Agency is concerned that a 12 hour REI is not restrictive enough to protect field workers from postapplication exposures to dicofol. Therefore, a new REI of 33 days will be established for stone fruit.

While the extended REI might impact timing of applications, other miticides are available which are as efficacious and economical as dicofol for mite control. Since the alternative miticides are currently used to treat more acres annually than dicofol, there is not likely to be either a biological pest control impact or economic impact on producers. Alternatives include, but are not limited to: abamectin, bifenazate, esfenvalerate, fenbutotin oxide, and insecticidal oils. A more complete list, as well as a discussion of alternatives, is included in the " Benefits Assessment for Dicofol on Apricots, Peaches, and Nectarines", dated March 23, 2005. In addition, dicofol can still be used but producers will need to schedule field activities around new REIs.

Pecans ( Tree Nuts) Dicofol is applied to pecans to control mites, primarily the leaf scorch mite. Dicofol use on pecans is highest in Georgia and Louisiana, where approximately 34% and 21% of pecans are treated, respectively.

Dicofol labels currently specify a 12 hour REI for pecans. The Agency is concerned that a short REI would allow workers to re enter treated fields when residue levels are of concern and field activities could result in extended periods of exposure. Therefore, a new REI of 49 days will be established for tree nuts.

Due to the application schedule for dicofol ( July through October) and that minimal field activities that require contact with treated foliage take place during this Page 5 of 5 time, extending REIs will not likely impact pecan production. To further ensure that workers do not come in contact with treated foliage and nuts for long periods of time, labels need to specify that dicofol can only be applied before pecan shuck split and need to be harvested mechanically.

Attachments:

1. Addendum to the Dicofol RED, dated September 8, 2005 2. Dicofol Revised Report of the Hazard Identification Assessment Review Committee, dated September 8, 1999.

3. Dicofol. Revised Refined Post Application Exposure Estimates ( Citrus, Stonefruit, Tree nut crops), dated July 29, 2004.

4. Dicofol: Revised Refined Post Application Exposure Estimates ( Apples, Pears, Beans, Cotton, Cucurbits, Grapes, Sod/ Turf), dated August 29, 2005.

5. Dicofol: Crop Specific Refined Post Application Exposure Estimates: Pecans, dated December 9, 2004.

6. Dicofol. Revised Refined Post Application Exposure Estimates for Hops, Mint & Strawberries, dated August 29, 2005.

7. BEAD Dicofol Crop Usage, dated June 25, 2004.

8. Benefits Assessment for Dicofol on Citrus: Oranges, Grapefruit, Tangerines, and Tangelos, dated April 13, 2005.

9. Pecans Benefits Assessment for Dicofol, dated March 23, 2005.

10. Benefits Assessment for Dicofol on Apricots, Peaches, and Nectarines, dated March 23, 2005.

11. Sow AgroSciences Response to Error Only Comment Period, dated August 17, 2005


MEMORANDUM

DATE:		September 29, 2012

TO:		RICE NESHAP Docket, EPA-HQ-OAR-2008-0708

FROM:	Melanie King, EPA OAQPS/SPPD/ESG

SUBJECT:	September 25, 2012 Meeting Regarding Proposed Amendments to the RICE NESHAP
--------------------------------------------------------------------------------

SUMMARY

      A meeting was held between the EPA and the attendees listed below on September 25, 2012 to discuss the comments submitted by the Electric Power Supply Association (EPSA) on the proposed amendments to the National Emission Standards for Hazardous Air Pollutants for Reciprocating Internal Combustion Engines. The amendments were proposed on June 7, 2012.

ATTENDEES

Gina McCarthy, EPA
John Shelk, EPSA
Janet McCabe, EPA
Bill Holden, GenOn
Joel Beauvais, EPA
Shahid Malik, PSEG
Joe Goffman, EPA
Thad Miller, Calpine
Peter Tsirigotis, EPA
Yvonne McIntyre, Calpine
Robert Wayland, EPA
Derek Furstenwerth, Calpine
Melanie King, EPA
Mike Eckard, First Energy


  HYPERLINK "javascript:PopUpMenu2_Set(Menu18048496);" \t "_self"  Links

Triclocarban enhances testosterone action: a new type of endocrine
disruptor?

  HYPERLINK
"http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22C
hen%20J%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_Results
Panel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus"  Chen J ,   HYPERLINK
"http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22A
hn%20KC%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_Results
Panel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus"  Ahn KC ,   HYPERLINK
"http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22G
ee%20NA%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_Results
Panel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus"  Gee NA ,   HYPERLINK
"http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22A
hmed%20MI%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_Resul
tsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus"  Ahmed MI ,
HYPERLINK
"http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22D
uleba%20AJ%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_Resu
ltsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus"  Duleba AJ ,
HYPERLINK
"http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22Z
hao%20L%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_Results
Panel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus"  Zhao L ,   HYPERLINK
"http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22G
ee%20SJ%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_Results
Panel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus"  Gee SJ ,   HYPERLINK
"http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22H
ammock%20BD%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_Res
ultsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus"  Hammock BD ,
HYPERLINK
"http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=Search&Term=%22L
asley%20BL%22%5BAuthor%5D&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_Resu
ltsPanel.Pubmed_DiscoveryPanel.Pubmed_RVAbstractPlus"  Lasley BL .

University of California, Center for Health and the Environment, Davis,
California 95616<EMAIL_ADDRESS>
Many xenobiotics have been associated with endocrine effects in a wide
range of biological systems. These associations are usually between
small nonsteroid molecules and steroid receptor signaling systems. In
this report, triclocarban (TCC; 3,4,4'-trichlorocarbanilide), a common
ingredient in personal care products that is used as an antimicrobial
agent was evaluated and found to represent a new category of
endocrine-disrupting substance. A cell-based androgen receptor-mediated
bioassay was used to demonstrate that TCC and other urea compounds with
a similar structure, which have little or no endocrine activity when
tested alone, act to enhance testosterone (T)-induced androgen
receptor-mediated transcriptional activity in vitro. This amplification
effect of TCC was also apparent in vivo when 0.25% TCC was added to the
diet of castrated male rats that were supported by exogenous
testosterone treatment for 10 d. All male sex accessory organs increased
significantly in size after the T+TCC treatment, compared with T or TCC
treatments alone. The data presented here suggest that the bioactivity
of endogenous hormones may be amplified by exposure to commercial
personal care products containing sufficient levels of TCC.


[Federal Register Volume 88, Number 182 (Thursday, September 21, 2023)]
[Notices]
[Pages 65177-65179]
[FR Doc No: 2023-20474]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2023-D-3550]

Considerations for the Conduct of Clinical Trials of Medical
Products During Major Disruptions Due to Disasters and Public Health
Emergencies; Guidance for Industry, Investigators, and Institutional
Review Boards; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a final guidance for industry entitled
``Considerations for the Conduct of Clinical Trials of Medical Products
During Major Disruptions Due to Disasters and Public Health
Emergencies.'' This guidance recommends approaches that sponsors of
clinical trials of medical products can consider when there is a major
disruption to clinical trial conduct and operations due to disasters or
public health emergencies, which can include but are not limited to
hurricanes, earthquakes, military conflicts, infectious disease
outbreaks, or bioterrorist attacks. The appendix to this guidance
further explains those approaches by providing answers to questions
that the Agency has received about conducting clinical trials during
major disruptions.

DATES: The announcement of the guidance is published in the Federal
Register on September 21, 2023.

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

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2023-D-3550 for ``Considerations for the Conduct of Clinical Trials
of Medical Products During Major Disruptions Due to Disasters and
Public Health Emergencies.'' Received comments will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper

submission. You should submit two copies total. One copy will include
the information you claim to be confidential with a heading or cover
note that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.''
The Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of this guidance to the
Division of Drug Information, Center for Drug Evaluation and Research,
Food and Drug Administration, 10001 New Hampshire Ave., Hillandale
Building, 4th Floor, Silver Spring, MD 20993-0002; or the Office of
Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the guidance document.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993,<PHONE_NUMBER>,
[email protected]; Anne Taylor, Center for Biologics Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
71, Rm. 7301, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or Soma Kalb,
Center for Devices and Radiological Health, 10903 New Hampshire Ave.,
Bldg. 66, Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a final guidance for
industry, investigators, and institutional review boards entitled
``Considerations for the Conduct of Clinical Trials of Medical Products
During Major Disruptions Due to Disasters and Public Health
Emergencies.'' Disasters and public health emergencies (PHEs) have the
potential to cause major disruptions in the conduct of clinical trials
for medical products. Such events can include, but are not limited to,
weather events, military conflicts, infectious disease outbreaks, and
bioterrorist attacks. The purpose of the guidance is to provide general
considerations to assist sponsors, investigators, and institutional
review boards in assuring the safety of trial participants, maintaining
compliance with good clinical practice, and minimizing risks to trial
integrity during disasters and PHEs that may lead to major disruption
of clinical trial conduct and operations. The appendix to the guidance
further explains these general considerations in a question-and-answer
format.
    FDA recognizes that disasters and PHEs can cause major disruptions
to the conduct of clinical trials of medical products. For example,
disasters or PHEs can lead to population quarantines, trial site
closures, travel limitations, interruptions to the supply chain for the
investigational product, or other considerations related to the type of
disaster or emergency. These challenges can create difficulties for
complying with protocol-specified procedures, including administering
or using the investigational product or adhering to protocol-specific
visits and laboratory/diagnostic testing. This final guidance provides
recommendations on how to manage major disruptions to clinical trials
during disasters and PHEs to help ensure the protection of participants
and the ability of clinical trials to generate evidence to support
regulatory decision-making during these times.
    The final guidance provides recommendations for helping to address
those challenges, including, among other things, recommendations
related to the safety of trial participants, whether to continue or
suspend a trial, protocol amendments and deviations, study monitoring,
alternative delivery of the investigational product, remote safety and
endpoint assessment, informed consent, and reporting of adverse events.
Some of the recommendations in this final guidance provide less
burdensome approaches that can be utilized, when appropriate, in the
conduct of clinical trials during major disruptions due to a disaster
or PHE and that are consistent with public health. For example, the
guidance provides recommendations regarding a change to virtual, rather
than in-person, clinical trial visits when necessary.
    In March 2020, FDA first published the guidance for industry
entitled ``Conduct of Clinical Trials of Medical Products During the
COVID-19 Public Health Emergency'' (COVID-19 Conduct guidance) to
support public health efforts following a declaration, under section
319 of the Public Health Service (PHS) Act (42 U.S.C. 247d), by the
Secretary of Health and Human Services of a public health emergency
related to Coronavirus Disease 2019 (the disease caused by SARS-CoV-2).
The COVID-19 Conduct guidance focused on addressing the COVID-19 PHE.
    In the Federal Register of March 13, 2023 (88 FR 15417), FDA listed
the COVID-19-related guidance documents that would no longer be
effective after the PHE declared under the PHS Act expired on May 11,
2023. The March 13, 2023, notice also listed COVID-19-related guidance
documents that FDA was revising to continue in effect for 180 days
after the expiration of the PHE declaration to provide a period for
stakeholder transition and then would no longer be in effect, and
documents that FDA was revising to continue in effect for 180 days
after the expiration of the PHE declaration, during which time FDA
planned to further revise the guidances with any appropriate changes
based on comments received and the Agency's experience with
implementation. The COVID-19 Conduct guidance was included in the
latter category and was revised to remain in effect for 180 days post-
expiration of the PHE declaration. FDA believes that most of the
recommendations set forth in the COVID-19 Conduct guidance are
applicable outside the context of the COVID-19 PHE to major disruptions
to clinical trial conduct in the setting of disasters and PHEs more
broadly. Consistent with what we said in the Federal Register of March
13, 2023, FDA is therefore issuing this revised final guidance, which
supersedes the

COVID-19 Conduct guidance. FDA's revisions include broadening the
guidance's scope to apply during disasters and PHEs, removing several
outdated questions, clarifying recommendations regarding use of risk-
based approaches for monitoring clinical investigations, clarifying
recommendations concerning charging for investigational products, and
making other editorial changes to improve clarity and consistency.
    FDA is issuing this guidance for immediate implementation in
accordance with our good guidance practices regulation (21 CFR
10.115(g)(3)) without initially seeking prior comment because the
Agency has determined that prior public participation is not feasible
or appropriate (see 21 CFR 10.115(g)(2) and section 701(h)(1)(C)(i) of
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 371(h)(1)(C)(i))).
Specifically, we are not seeking prior comment because disasters and
PHEs may occur without notice and, as we have learned from experience
during the COVID-19 PHE, may rapidly cause major disruptions to
clinical trial conduct. It is thus important to public health to
provide guidance on approaches to assure the safety of trial
participants and minimize risks to trial integrity during such major
disruptions. Moreover, portions of the guidance reflect a less
burdensome approach that is consistent with public health and that can
be used during a disaster or PHE when appropriate. Interested parties
had an opportunity to comment on the recommendations in the COVID-19
Conduct guidance, and FDA considered those comments when revising the
guidance to apply those recommendations to disasters and public health
emergencies more broadly. Although this guidance document is being
implemented immediately, it remains subject to comment in accordance
with FDA's good guidance practices regulation (Sec.  10.115(g)(3)(D)).
    The guidance represents the current thinking of FDA on
``Considerations for the Conduct of Clinical Trials of Medical Products
During Major Disruptions Due to Disasters and Public Health
Emergencies.'' It does not establish any rights for any person and is
not binding on FDA or the public. You can use an alternative approach
if it satisfies the requirements of the applicable statutes and
regulations.

II. Paperwork Reduction Act

    While this guidance contains no collection of information, it does
refer to previously approved FDA collections of information. The
previously approved collections of information are subject to review by
the Office of Management and Budget (OMB) under the Paperwork Reduction
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information
in 21 CFR part 11 have been approved under OMB control number 0910-
0303; the collections of information in 21 CFR parts 50 and 56 have
been approved under OMB control number 0910-0130; the collections of
information in 21 CFR part 312 have been approved under OMB control
number 0910-0014; the collections of information in 21 CFR part 314
have been approved under OMB control number 0910-0001; the collections
of information in 21 CFR part 320 have been approved under OMB control
number 0910-0630; the collections of information in 21 CFR part 812
have been approved under OMB control number 0910-0078; and the
collections of information in 21 CFR part 814 have been approved under
OMB control number 0910-0231.

III. Electronic Access

    Persons with access to the internet may obtain the guidance at
https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances,
https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.

    Dated: September 18, 2023.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2023-20474 Filed 9-20-23; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 180 (Monday, September 17, 2012)]
[Rules and Regulations]
[Pages 57026-57029]
[FR Doc No: 2012-22797]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2012-0764]
RIN 1625-AA09

Drawbridge Operation Regulation; Black Warrior River, AL

AGENCY: Coast Guard, DHS.

ACTION: Final rule.

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

SUMMARY: The Coast Guard is adding a special operating regulation
governing the Alabama Gulf Coast Railroad (AGR) vertical lift span (Yo-
Yo) bridge across the Black Warrior River, mile 219.0, at Demopolis,
AL. The bridge is operated automatically and currently remains in the
open-to-navigation position and only lowers for the passage of trains.
This rule proposes to codify the current operating schedule of the
bridge as a special operating regulation.

DATES: This rule is effective September 17, 2012.

ADDRESSES: Documents indicated in this preamble as being available in
the docket, are part of docket USCG-2012-0764 and are available by
going to http://www.regulations.gov, inserting USCG-2012-0764 in the
``Keyword'' box, and then clicking ``Search.'' This material is also
available for inspection or copying at the Docket Management Facility
(M-30), U.S. Department of Transportation, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590, between
9 a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email David Frank, Bridge Administration Branch; telephone 504-
671-2128, email<EMAIL_ADDRESS>If you have questions on
viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Table of Acronyms

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of Proposed Rulemaking
Sec.  Section Symbol
USACE U.S. Army Corps of Engineers
U.S.C. United States Code

A. Regulatory History and Information

    The Coast Guard is issuing this final rule without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this rule because the Coast Guard is only codifying the
known and accepted operation of the drawbridge that has been automated
for over 50 years. Publication of the automated operation of the
drawbridge will not modify the present operation of the

bridge and mariners will notice no changes in the way the bridge
operates for the passage of vessels. Therefore, it is unnecessary to
provide the notice and comment period for this rule.
    For similar reasons, under 5 U.S.C. 553(d)(3), the Coast Guard
finds that good cause exists for making this rule effective in less
than 30 days after publication in the Federal Register (FR). The bridge
has been operating under the automated system for over 50 years.
Mariners presently understand that the bridge will remain in the open
position and only be lowered for the passage of trains. They also
understand that no tender is located at the bridge and the operation of
the bridge is automated. The bridge is commonly referred to as the
``Yo-Yo'' bridge because of the automated operation of the bridge. This
rule only codifies the operation of the automated bridge in the Code of
Federal Regulations (CFR). Therefore, providing a 30 day notice before
making this rule effective is unnecessary.

B. Basis and Purpose

    The AGR vertical lift span (Yo-Yo) bridge across the Black Warrior
River, mile 219.0, at Demopolis, AL, is currently maintained in the
open-to-navigation position, closing only for the passage of rail
traffic. The bridge has a vertical clearance of 18 feet above the
Bridge Reference Elevation for Navigation Clearances (BRENC), elevation
79.8 feet NGVD, in the closed-to-navigation position and 62.9 feet
above BRENC in the open-to-navigation position.
    Due to the limited number of trains using the rail line in this
area, maintaining the bridge in the fully open-to-navigation position
and only lowering the bridge for rail traffic is the preferred
operating schedule. The system for operation of the bridge is an
automated system in place since 1961. The method of operation for the
bridge to remain open to navigation and to signal and then close for
the passage of a train and then to automatically reopen has been
understood by mariners for over 50 years. Due to this method of
operation, the bridge is commonly known as the Yo-Yo Bridge. Because
this operating schedule has been in place for over 50 year and is
understood and accepted by local traffic, the bridge owner requested
that the Coast Guard publish the current operating schedule. This
operating schedule allows vessels to transit the waterway as normal
while permitting the bridge to lower for train traffic after ensuring
that no vessels are approaching the bridge.
    The automated system for operating the bridge allows the bridge to
operate efficiently while remaining untended and in the open-to-
navigation position. This rule codifies this practice by publishing the
known and accepted operating schedule under 33 CFR 117.42.

C. Discussion of Final Rule

    Under 33 CFR part 117.5, bridges are required to open on signal for
the passage of vessels except as otherwise authorized or required. The
Yo-Yo Bridge is currently untended and maintained in the open-to-
navigation position and operates automatically to close for the passage
of trains. As the bridge is presently operating as an automated
drawbridge and this method of operation has been previously approved by
the U.S. Army Corps of Engineers when they had oversight of the
permitting and operations of drawbridges. Title 33 CFR 117.42(b)
requires that, if approved, a description of the full operation of the
remotely operated or automated drawbridge will be added to subpart B of
this part.
    This present method of operation is known and understood by the
local waterway users, but this operating schedule is not reflected in
the CFR. This rule publishes the known operating schedule, codifying
the schedule as a Special Operating Requirement under 33 CFR part 117,
Subpart B.
    The automated operation of the draw of the AGR vertical lift span
(Yo-Yo) bridge across the Black Warrior River, mile 219.0, at
Demopolis, AL is as follows:
    (a) The draw shall be maintained in the fully open-to-navigation
position for vessels at all times, except during periods when it is
closed for the passage of rail traffic.
    (b) When rail traffic approaches, railroad track circuits will
initiate the automatic bridge opening and closing sequences. (Estimated
duration that the bridge will remain closed for passage of rail traffic
is 10 to 15 minutes per closure.)
    (c) Upon detecting approaching rail traffic, the track circuits
will initiate bridge closing warnings consisting of continuous horn
blowing and the navigation lights changing to flashing yellow. Photo-
electric (infrared) boat detectors will monitor the waterway beneath
the bridge for the presence of vessels.
    (d) At the end of a six-minute warning period, if no vessels have
been detected by the boat detectors, the bridge lowering sequence will
automatically proceed taking approximately two minutes to complete. As
soon as the bridge leaves the up position, the horn will silence but
the navigation lights change to flashing red.
    (e) Upon passage of the rail traffic, the bridge will automatically
open unless another movement is detected. The navigation lights will
continue to flash red until the bridge has returned to the full open
position at which time they will change to steady green.
    (f) The bridge can also be operated from two locked trackside
control locations (key releases) on the approach spans, one on each
side of the movable span.
    (g) To request openings of the bridge when the lift span is in the
closed-to-navigation position, mariners may contact the AGR via VHF-FM
channel 16 or by telephone at<PHONE_NUMBER>.

D. 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 or executive orders.

1. Regulatory Planning and Review

    This rule is not a ``significant regulatory action'' under section
3(f) of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of Order 12866 or under
section 1 of Executive Order 13563. The Office of Management and Budget
has not reviewed it under those Orders.
    This rule codifies the current operating schedule for the AGR
bridge which is already understood, known and accepted by the local
bridge and waterway users. Very few vessels will be impacted as the
bridge remains open at all times except to allow rail traffic to pass.

2. Impact on Small Entities

    This rule would affect the following entities, some of which may be
small entities: the owners or operators of vessels wishing to transit
the Black Warrior River above mile 219.0 with vessel air drafts that
would require the bridge to be open to navigation for them to pass
safely through the bridge site.
    This action will not have a significant economic impact on a
substantial number of small entities because the bridge remains open at
all times except to allow rail traffic to pass.

3. Assistance for Small Entities

    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, above.
    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.

4. Collection of Information

    This rule would call for no new collection of information under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

5. Federalism

    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 does not have implications for federalism.

6. 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.

7. 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.

8. Taking of Private Property

    This rule would not affect a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

9. Civil Justice Reform

    This rule meets applicable standards in sections 3(a) and 3(b)(2)
of Executive Order 12988, Civil Justice Reform, to minimize litigation,
eliminate ambiguity, and reduce burden.

10. Protection of Children

    We have analyzed this rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and would not create an
environmental risk to health or risk to safety that might
disproportionately affect children.

11. Indian Tribal Governments

    This rule does not have tribal implications under Executive Order
13175, Consultation and Coordination with Indian Tribal Governments,
because it would 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.

12. Energy Effects

    This rule is not a `significant energy action' under Executive
Order 13211, Actions Concerning Regulations That Significantly Affect
Energy Supply, Distribution, or Use because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

13. Technical Standards

    This rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

14. Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01, and Commandant Instruction M16475.lD which
guides the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have determined
that this action is one of a category of actions which do not
individually or cumulatively have a significant effect on the human
environment. This rule simply promulgates the operating regulations or
procedures for drawbridges. This rule is categorically excluded, under
figure 2-1, paragraph (32)(e), of the Instruction.
    Under figure 2-1, paragraph (32)(e), of the Instruction, an
environmental analysis checklist and a categorical exclusion
determination are not required for this rule. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this rule.

List of Subjects in 33 CFR Part 117

    Bridges.
    For the reasons discussed in the preamble, the Coast Guard amends
33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

0
1. The authority citation for part 117 continues to read as follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

0
2. Section 117.106 is added to read as follows:

Sec.  117.106  Black Warrior River.

    The draw of the Alabama Gulf Coast (AGR) vertical lift span (Yo-Yo)
bridge across the Black Warrior River, mile 219.0, at Demopolis, shall
operate as follows:
    (a) The draw shall be maintained in the fully open-to-navigation
position for vessels at all times, except during periods when it is
closed for the passage of rail traffic.
    (b) Railroad track circuits will initiate the automatic bridge
opening and closing sequences. (Estimated duration that the bridge will
remain closed for passage of rail traffic is 10 to 15 minutes.)
    (c) Upon detecting an approaching train, the track circuits will
initiate bridge closing warning consisting of continuous horn blowing
and the navigation lights changing to flashing yellow. Photoelectric
(infrared) boat detectors will monitor the waterway beneath the bridge
for the presence of vessels.
    (d) At the end of a six-minute warning period, if no vessels have
been detected by the boat detectors, the bridge

lowering sequence will automatically proceed taking approximately two
minutes to complete. As soon as the bridge leaves the up position, the
horn will silence but the navigation lights change to flashing red.
    (e) Upon passage of the train, the bridge will automatically open
unless another movement is detected. The navigation lights will
continue to flash red until the bridge has returned to the full open
position at which time they will change to steady green.
    (f) The bridge can also be operated from two locked trackside
control location (key releases) on the approach spans, one on each side
of the movable span.
    (g) To request openings of the bridge when the lift span is in the
closed-to-navigation position, mariners may contact the AGR via VHF-FM
channel 16 or by telephone at<PHONE_NUMBER>.

    Dated: August 25, 2012.
Roy A. Nash,
Rear Admiral, U.S. Coast Guard, Commander, Eighth Coast Guard District.
[FR Doc. 2012-22797 Filed 9-14-12; 8:45 am]
BILLING CODE 9110-04-P