                               Site Visit Report

	Brunswick Steam Electric Plant       Highway 87 North Southport, NC 27562        January 28, 2008

1.0 Background and Objectives

      The Environmental Protection Agency (EPA) is in the process of revising the 316(b) Phase II regulation.  As part of this process, EPA staff is visiting several electric generators to better understand the cooling water intake structure (CWIS) technologies in use at typical facilities, including the site-specific characteristics of each facility and how these affect the selection and performance of CWIS technologies.  Brunswick Steam Electric Plant (Brunswick) was selected for a site visit due to its use of fine mesh traveling screens with a fish return and its relatively large intake flows.

2.0 Facility Description

      Brunswick is a two unit nuclear facility in North Carolina 40 miles south of Wilmington. Unit 1 is a 938 MWe General Electric Type 4 boiling water reactor that began operations in September 1976.  Unit 2 is a 937 MWe General Electric Type 4 boiling water reactor that began operations in December 1974. The source waterbody for cooling is tidal water (salinity typically 15 to 30 parts per thousand) obtained from Walden Creek near the Cape Fear River estuary.  The owner Carolina Power & Light (Progress Energy) employs about 900 employees. Brunswick permit number is NC0007064, expired as of November 30, 2006.

3.0 Electricity Generation and Transmission              Total generating capacity is approximately 1580 MW of nuclear fueled power for baseload electricity with a capacity utilization rating of 94.7 percent. Scheduled outages that include refueling occur every year alternating between units 1 and 2.  Outages are usually for 20 to 30 days.

4.0 Cooling Water Intake Structure

      The Cape Fear River Estuary is an elongated shallow bay with a narrow dredged deep ship's channel. Above the narrow constriction at Sunny Point, the estuary is highly stratified with salt water intrusion along the bottom and freshwater flow out along the surface. Below Sunny Point the estuary is well mixed and characterized by a large ocean exchange rate of about 80 percent of the water over a 12-h period. Brunswick obtains cooling water from the lower reach, with approximately 0.74 percent of the tidal excursion withdrawn by the intake canal.       Brunswick has vertical turtle bars (bar racks) at the canal entrance. Additional fish diversion structure with 3/8 inch (9.4 mm) screens installed in 1982.  The diversion structure is located near the confluence of the intake canal and Walden Creek. Copper-nickel screen panels are set between reinforced concrete pilings. Mechanical grass rakes keep debris out of the canal. The canal is dredged 18 feet deep with frequency dictated by annual storm events. Design intake flow is 1.9 billion gallons daily, with the actual intake (3-year average) reported as 1.427 billion gallons daily with an intake velocity of 0.98 feet per second.                A fine mesh and a fish return handling system was installed in 1983. After the 2.7 mile long intake canal, water flows to each generating unit's cooling system consisting of four intake bays and pumps. Originally, vertical traveling screens installed in each bay were fitted with 9.4 mm mesh screens. Eight fine mesh FMC screens were retrofit on the traveling screens to reduce entrainment of larvae. The third fine-mesh screen per unit was installed in 1987. As of a 2000 study, three of the four traveling screens for each unit were fitted with 1 mm fine-mesh screens. Currently, an alternative configuration is being studied where 1 mm fine mesh overlay is installed on 2 of 4 screens creating a 50/50 panel on the two bays. The other two bays have fine mesh screens on all panels.  The traveling screens have two operating speeds, where the higher speed is triggered by a pressure drop across the screens. The screens are visually inspected twice daily. Impinged organisms are washed off the screens into a 1.4-km fiberglass fish return. The organisms are transported to a constructed holding pond that is open to a tributary of Walden Creek, allowing impinged organisms a full return route to the sourcewater.                December through March flow reduction management is utilized for further protection of larval fin fish. Cooling water flow is reduced from 31.1 cm/unit to 26.1 cm/unit. Normally, all flow is through traveling screens fitted with fine mesh. The cooling water flow for one unit only is allowed to be increased to 34.8 cm during July, August, and September by using a forth intake pump fitted with 9.4-mm mesh screens.

      Seasonal algae has been observed to foul the intake. Biocontrol is conducted by addition of hypochlorite and brome into the service water bays every other hour, and to the salt water pumps twice a day. A silicone coating on the main cooling water system further reduces biofouling.               The return canal is a 5 mile open canal that is eventually piped under the Intra-Coastal Waterway and remains submerged into the Atlantic Ocean.  The returned warm water is dispersed 200 feet offshore the Oak Island area. Water is returned less than 4 degrees F higher at the ocean. Permit conditions allow for a 2 acre mixing zone, with a 2,000 acre grid monitored for compliance.

5.0 Impingement and Entrainment Information

      Brunswick has conducted a representative species approach to population level effects as part of the demonstration to the state that there is no adverse environmental impact; population modeling is not required by the state.  Brunswick has conducted some form of monitoring for more than 30 years. Brunswick staff indicated their data shows that the species composition, seasonality, and abundance of organisms has not changed as a result of operation of the plant.              As early as 1968, baseline studies were designed to collect preliminary biological and environment data prior to simultaneous operation of both units. Initial studies were conducted when plant operations commenced in the 70's. Detailed I&E studies were conducted weekly in the mid-80s. Sampling was conducted 3/day and 3/night over a 24 hour period, with data stratified by the tide conditions. Two nets in the discharge canal are used to collect organisms to show comparative density of entrainment.  Overall abundance was generally found to be lower in the fall.  Brunswick performance data showed 84 percent reductions in entrainment with the fine mesh over regular mesh (9.4 mm).  Impingement mortality reductions ranging from 40 to 92 percent were observed depending on species and mesh configuration.  Currently monitored species of interest include Atlantic menhaden, spot, blue crab, and shrimp.  Other previously monitored species include croaker, flounder, mullet, bay anchovy, and sea trout. Potential impacts to threatened and endangered (T&E) species include short-nosed sturgeon and turtles.         6.0 Additional Information

      The base for a natural draft wet cooling was built, but the tower was not completed due to projected adverse impacts to air.

List of attendees: Charles Nelson, Thomas Thompson

Attachments:

Please see DCN 10-6559A through Q accompanying this document for photos from the site visit.


[Federal Register Volume 78, Number 51 (Friday, March 15, 2013)]
[Rules and Regulations]
[Pages 16414-16423]
[FR Doc No: 2013-06083]

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DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration

[Docket No. FRA-2009-0041, Notice No. 3]

49 CFR Part 234

RIN 2130-AC38

Systems for Telephonic Notification of Unsafe Conditions at
Highway-Rail and Pathway Grade Crossings

AGENCY: Federal Railroad Administration (FRA), Department of
Transportation (DOT).

ACTION: Final rule; response to petition for reconsideration.

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

SUMMARY: This document responds to a petition for reconsideration of
FRA's final rule published on June 12, 2012, mandating that certain
railroads establish and maintain systems that allow members of the
public to call the railroads, using a toll-free telephone number, and
report an emergency or other unsafe condition at highway-rail and
pathway grade crossings. This document amends and clarifies the final
rule.

DATES: This final rule is effective May 14, 2013.

FOR FURTHER INFORMATION CONTACT: Beth Crawford, Transportation
Specialist, Grade Crossing Safety and Trespass Prevention, Office of
Safety Analysis, FRA, 1200 New Jersey Avenue SE., Mail Stop 25,
Washington, DC 20590 (telephone:<PHONE_NUMBER><EMAIL_ADDRESS>
or Sara Mahmoud-Davis, Trial Attorney, Office of Chief Counsel, FRA,
1200 New Jersey Avenue SE., Mail Stop 10, Washington, DC 20590
(telephone:<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    This rule implements Section 205 (Sec. 205) of the Rail Safety
Improvement Act of 2008 (RSIA), Public Law 110-432, Division A, which
was signed into law on October 16, 2008. Sec. 205 of the RSIA mandates
that the Secretary of Transportation require certain railroad carriers
(railroads) to take a series of specified actions related to setting up
and using systems by which the public is able to notify the railroad by
toll-free telephone number of safety problems at its highway-rail and
pathway grade crossings. Such systems are commonly known as Emergency
Notification Systems (ENS) or ENS programs. On March 4, 2011, FRA
issued a notice of proposed rulemaking (NPRM) (76 FR 11992) that would
require railroads to implement an ENS, through which they receive
reports of unsafe conditions at crossings. See 76 FR 11992. A public
hearing on the proposal was held on September 29,

2011. 76 FR 55622(Sept. 8, 2011). On June 12, 2012, following
consideration of written comments received in response to the NPRM, FRA
published a final rule in this rulemaking (Final Rule). See 77 FR
35164.
    On August 9, 2012, FRA received a petition for reconsideration of
the Final Rule from the Association of American Railroads (AAR) (AAR
Petition or Petition). On September 25, 2012, FRA received comments on
the AAR Petition from the Brotherhood of Railroad Signalmen (BRS). The
specific issues raised by the AAR Petition, the comments on the
Petition from BRS, and FRA's responses to the Petition and comments,
are discussed in detail below in the ``Section-by-Section Analysis''
portion of the preamble. The Section-by-Section Analysis also contains
a detailed discussion of each provision of the Final Rule that FRA has
amended or clarified. The amendments contained in this document
generally clarify or reduce requirements currently contained in the
Final Rule or allow for greater flexibility in complying with the Final
Rule, and are within the scope of the issues and options discussed,
considered, or raised in the NPRM.
    Separately, on September 24, 2012, FRA received a public submission
of comments from the co-owner of the company 1-800 RR Emergency on
behalf of that company. The comments were unrelated to the AAR Petition
and raised a new issue. The commenter 1-800 RR Emergency had ample time
to raise its concerns between the time that the NPRM was published on
March 4, 2011, and the publication of the Final Rule on June 12, 2012.
The comment period for the NPRM remained open until May 3, 2011.
Furthermore, FRA held a public hearing on September 29, 2011, to
receive oral comments in response to the NPRM. Additionally, following
the publication of the Final Rule, petitions for reconsideration of the
Final Rule were accepted until August 13, 2012. FRA is unable to
comment on the issue raised by 1-800 RR Emergency at this late date
because doing so would deny the public the opportunity to comment on
the issue. If the company would like FRA to address the issue, it is
welcome to file a petition for rulemaking on this subject in accordance
with the provisions of 49 CFR part 211. See 49 CFR 211.7 and 211.9.

II. Section-by-Section Analysis

Amendments to 49 CFR Part 234

Subpart E--Emergency Notification Systems for Telephonic Reporting of
Unsafe Conditions at Highway-Rail and Pathway Grade Crossings

Section 234.305 Remedial Actions in Response to Reports of Unsafe
Conditions at Highway-Rail and Pathway Grade Crossings

AAR Petition: ``FRA Should Clarify the Effective Date for Compliance
With Requirements to Respond to Reports of Unsafe Conditions''
    Section 234.305 addresses the actions that a railroad must take in
response to an ENS-generated report of an unsafe condition at a
highway-rail or pathway grade crossing. In the Petition, AAR points out
that the Final Rule does not explicitly state an effective date for
this section with respect to railroads that, as of August 13, 2012,
were using an ENS telephone service or a third-party ENS telephone
service that did not conform to the requirements in Sec.  234.303 or
Sec.  234.307, respectively. Compliance with the requirements in Sec.
234.305 is dependent upon a railroad's establishment of a compliant ENS
telephone service, pursuant to Sec.  234.303 or Sec.  234.307.
Accordingly, FRA is amending the Final Rule to state expressly in Sec.
234.317(b), ``Compliance Dates,'' that a railroad with a non-conforming
ENS telephone service as of August 13, 2012, must implement an ENS that
conforms to this subpart no later than March 1, 2014, subject to the
exceptions in paragraphs (c), (d), and (e) of Sec.  234.317.
Additionally, FRA is amending paragraph (e) of Sec.  234.317 to extend
the deadline from September 1, 2013, to March 1, 2014, for railroads to
bring their recordkeeping into compliance. Since proper recordkeeping
also depends upon a railroad implementing a conforming ENS telephone
service, FRA believes that the deadline for compliance with Sec.
234.313 and Sec.  234.315 should also be March 1, 2014. BRS did not
respond to the AAR Petition on this issue.
AAR Petition: ``FRA Should Clarify the Responsibility To Respond to
Obstructions on Non-Railroad Property''
    Paragraph (f) of Sec.  234.305 is the general rule on response to a
report of an obstruction to the view of a pedestrian or a vehicle
operator for a reasonable distance in either direction of a train's
approach to the highway-rail or pathway grade crossing (i.e., visual
obstruction). Paragraph (g) of Sec.  234.305 is the general rule on
response to a report of other unsafe conditions at a highway-rail or
pathway grade crossing not covered by other subsections of Sec.
234.305. Paragraphs (f) and (g) of Sec.  234.305, respectively, require
the maintaining railroad either to remove an obstruction of view or to
correct an unsafe condition at a highway-rail or pathway grade
crossing, if it is lawful and feasible to do so.
    In the Petition, AAR requests confirmation that it correctly
interprets the clause ``if it is lawful and feasible to do so'' in
paragraphs (f) and (g) of Sec.  234.305 to mean that ``[t]hese mandates
do not cover obstructions and unsafe conditions on non-railroad
property.'' AAR explains that ``[r]ailroads * * * cannot control what
takes place on property belonging to others.'' FRA confirms that the
mandates in paragraphs (f) and (g) of Sec.  234.305, respectively, only
require a railroad to take action to remedy an obstruction of view or
other unsafe condition on the railroad's property, to the extent that
the railroad is operating within the confines of the law and such
action is feasible. However, in circumstances where the property at
issue does not belong to the railroad, the railroad may still be in a
position to discuss the situation with the property owner, and work
jointly to reach a legal agreement with the owner to remedy the
condition if possible. FRA encourages such cooperation between the
railroad and property owner, but it would most likely depend upon the
railroad's willingness to take the initiative to attempt to resolve the
situation, as well as the willingness of the property owner to work
with the railroad. BRS did not respond to the AAR Petition on this
issue.

Section 234.306 Multiple Dispatching or Maintaining Railroads With
Respect to the Same Highway-Rail or Pathway Grade Crossing; Appointment
of Responsible Railroad

AAR Petition: ``FRA Should Clarify the Compliance Deadline for Signs at
Crossings Where Multiple Railroads Operate''
    Section 234.306 addresses the situation of multiple railroads that
dispatch trains through the same crossing, as well as the possibility
that multiple railroads have maintenance responsibilities for the same
crossing. In this section in the Final Rule, FRA recognizes that there
are some situations where there are multiple tracks at a grade crossing
where each railroad dispatches trains over its own track. Under these
circumstances, FRA believes it would create confusion if

each railroad posts a sign with its own emergency telephone number.
Having more than one emergency number posted at such crossings would
not only be more confusing for the users of the crossing and an
unnecessary cost for the multiple railroads, but also a less effective
method of responding to reports of unsafe conditions.
    As AAR points out in its Petition, at a single crossing, there may
currently be one ENS sign displaying the emergency telephone number for
one railroad and another ENS sign displaying the emergency telephone
number for a different railroad. AAR requests that for crossings where
multiple railroads dispatch trains through the same crossing and/or
maintain the same crossing, and there are currently multiple signs at
these crossings, that railroads be granted a deadline of September 1,
2017, to bring these crossings into compliance with this subpart. AAR
states that since this is ``[a]n issue of taking down signs due to
multiple signs being present at crossings, the lowest priority should
be placed on bringing these crossings into compliance.'' FRA disagrees
with AAR's assessment that bringing these crossings into compliance
should be a low priority compared to other highway-rail and pathway
grade crossings covered by this subpart.
    There are approximately 212,000 public and private at-grade
highway-rail and pathway grade crossings in the United States. FRA
estimates that there are approximately 2,500 highway-rail and pathway
grade crossings (i.e., approximately one percent of the total number of
highway-rail and pathway grade crossings) where more than one railroad
dispatches trains through the crossing. As stated previously in the
preamble to the Final Rule, FRA believes that having more than one
emergency number posted at such crossings is confusing for the users of
the crossing. Furthermore, the existence of multiple signs with
different emergency numbers at the same crossing could result in
miscommunication or a delay in communication of an unsafe condition to
the responsible railroad, thereby stalling remedial action efforts and
potentially placing users of the crossing at greater risk. BRS
expressed concern, similar to that of FRA, that granting an extension
for these crossings to come into compliance would result in
``[c]onfusion for the traveling public as to which railroad to contact
in case of an emergency.'' Approximately one percent of all public and
private highway-rail and pathway grade crossings are at issue here, and
even fewer of these crossings currently have multiple ENS signs posted
at them. FRA believes that the railroads that dispatch trains through
these crossings and maintain these crossings have ample time to comply
with the March 1, 2014, deadline in amended paragraph (b) of Sec.
234.317 for railroads with nonconforming ENS telephone service.

Section 234.311 ENS Sign Placement and Maintenance

AAR Petition: ``FRA Should Delete the Requirement To Place a Sign at
Private Industrial Facilities''
    Section 234.311(a)(1) requires a sign of the type specified by
Sec.  234.309 to be placed and maintained on each approach to a
highway-rail and pathway grade crossing with certain exceptions. The
maintaining railroad for the crossing would be responsible for the
proper placement and maintenance of the sign. The dispatching railroad
for the crossing would be responsible for providing the telephone
number that should be displayed on the sign to the maintaining
railroad, if the two are not the same railroad.
    Paragraph (a)(2)(ii) of Sec.  234.311 permits an exception,
requiring a railroad to only place and maintain one sign at each
vehicular entrance to a railroad yard, a port or dock facility, or a
private industrial facility that does not meet the definition of a
``plant railroad'' in Sec.  234.5, rather than placing and maintaining
signs at each approach to a crossing within the yard, port or dock
facility, or private industrial facility. In the Petition, AAR contends
that with respect to private industrial facilities this requirement is
``impractical'' because these entrances are not on railroad property,
and thus the railroad lacks the authority to carry out such a
requirement. Additionally, AAR points out that typically a railroad
does not have dispatching responsibility for a crossing inside a
private industrial facility, so this subpart would not even apply under
such circumstances.
    In considering the AAR Petition, FRA has decided to amend the
requirement in paragraph (a)(2)(ii) of Sec.  234.311 to require a
railroad only to place and maintain one sign at each vehicular entrance
to a railroad yard, or a port or dock facility, eliminating the
requirement as it pertains to private industrial facilities. BRS
commented that it is concerned for the safety of vehicular and
pedestrian traffic inside of these private industrial facilities. FRA
shares similar concerns, but as stated previously in the preamble to
the Final Rule, trains typically operate in these facilities at very
low speed, and thus the hazards of a collision are reduced.
Additionally, FRA agrees with AAR that the railroad does not own the
property at the entrances to private industrial facilities, nor does a
railroad own the track inside of these facilities. Consequently, it is
not practical to require a railroad to place and maintain ENS signs in
these locations on rights-of-way that it does not own. Furthermore,
such a requirement is outside of the scope of Sec. 205 of the RSIA,
which mandates that FRA require each railroad to ``ensure the placement
at each grade crossing on rights-of-way that it owns of appropriately
located signs.''
AAR Petition: ``FRA Should Address Missing and Damaged Signs''
    In the Final Rule, this subpart does not address the issue of
missing and damaged ENS signs at highway-rail and pathway grade
crossings. In the Petition, AAR contends that a railroad should not be
held responsible for ENS signs that are missing or damaged when the
railroad is unaware of the problem or had insufficient time to remedy
the situation. Consequently, AAR requests that FRA amend the Final Rule
to add a provision that grants a railroad 30 days from first learning
of the problem with an ENS sign to repair or replace the sign. FRA
understands AAR's concern that the repair or replacement of an ENS sign
takes some time, particularly because an ENS sign is specific to each
crossing, by identifying the U.S. DOT National Crossing Inventory
number for that crossing. BRS in its comments also agrees with AAR that
it takes time to replace a damaged or missing ENS sign, but notes that
a railroad should be inspecting its ENS signs on a regular basis.
    Pursuant to FRA regulations, a railroad is required to routinely
inspect its grade crossing signal systems, as well as its tracks, and
it is during such inspections that it most likely would learn of a
problem with an ENS sign at a crossing. FRA did not intend in the Final
Rule to implement a strict liability standard for missing and damaged
ENS signs. Accordingly, FRA has decided to amend the Final Rule to add
paragraph (c), ``Repair or replacement of ENS sign,'' to Sec.  234.311.
This new paragraph states that ``If an ENS sign required by this
subpart is discovered by the responsible railroad to be missing,
damaged, or in any other way unusable to vehicular or pedestrian
traffic, the responsible railroad shall repair or replace the sign no
later than 30 calendar days from the time of detection.'' Additionally,
as BRS notes in its response to the AAR Petition, 49

CFR 234.245 (a provision of 49 CFR part 234, subpart D, Maintenance,
Inspection, and Testing) already has a separate requirement that signs
mounted on a highway-rail grade crossing signal post be maintained in
``good condition and be visible to a highway user.''

Section 234.317 Compliance Dates

AAR Petition: ``The Grandfathering Clause is too Narrow''
    Section 234.317 provides the date by which each of various groups
of railroads must comply with this subpart. As explained above in the
discussion of Sec.  234.305, in response to the AAR Petition, FRA has
decided to amend paragraph (b) of Sec.  234.317. The revised paragraph
(b) grants a railroad with a nonconforming ENS telephone service until
March 1, 2014, to comply with this subpart, subject to the exceptions
in paragraphs (c), (d), and (e) of Sec.  234.317.
    In the Petition, AAR states that the dimensional requirements in
paragraph (c)(1)(i) of Sec.  234.317 exclude approximately 33,000 ENS
signs already in place at highway-rail and pathway grade crossings
through which Canadian Pacific (CP), CSX Transportation (CSXT), and
Union Pacific Railroad (UP) dispatch trains. Specifically, for these
signs currently in use by CP, CSXT, and UP, the lettering on the signs
that explains the purpose of the sign (e.g., ``Report emergency or
problem to ------'') is smaller than the minimum \3/4\-inch height
mandated by paragraph (c)(1)(i). AAR requests that FRA amend paragraph
(c)(1)(i) of Sec.  234.317 so that these signs may continue to be used
for the remainder of their useful life. Furthermore, AAR explains in
the Petition that replacement of these ENS signs by CP, CSXT, and UP is
estimated to cost a total of approximately $3.7 million. BRS contends
that this is an inflated cost estimate because the crossings where
these signs are located are likely visited on a routine basis for
testing purposes, which would reduce the labor costs associated with
replacing the signs. BRS also expresses concern that smaller lettering
on the ENS sign might compromise the safety of vehicular traffic, by
requiring the operator or passenger to exit the vehicle to read the
sign.
    All three railroads--CP, CSXT, and UP--supplemented the AAR
Petition by submitting to FRA the actual grade crossing signs at issue.
Additionally, in a letter sent to FRA dated August 29, 2012, CSXT
explained that beginning in 2010 it installed approximately 10,000 ENS
signs at its grade crossings that meet all the dimensional requirements
of paragraph (c)(1)(i) except for the lettering requirement for the
words that explain the purpose of the sign. In a letter sent to FRA
dated September 7, 2012, CP explained that its decal sign is applied to
an aluminum sheet before being installed on the cross buck posts at
passive at-grade crossings, and at active at-grade crossings the decal
is applied directly to the signal mast. CP also indicated that the sign
at issue here is currently in use on territories trading as CP that are
or were once part of the Soo Line Railroad Company and Milwaukee Road
Railroad in the States of Illinois, Minnesota, North Dakota, South
Dakota, and Wisconsin. However, CP does not use this sign on its
Dakota, Minnesota & Eastern Railroad Corporation or the Delaware &
Hudson Railway Co., Inc. territories.
    In the Petition, AAR suggests that FRA eliminate the minimum height
requirement for the lettering on the sign that explains the purpose of
the sign, or alternatively suggests that FRA permit a \3/8\-inch
minimum letter height for these words. In preparation of the Final
Rule, FRA conducted extensive research on the size and lettering
requirements for highway signs, consulting the Manual on Uniform
Traffic Control Devices (MUTCD) and independently surveying ENS signs
that are currently in place at crossings throughout the country. After
careful consideration of the AAR Petition and the supplemental
information and signs provided to FRA by CP, CSXT, and UP, FRA has
decided to amend paragraph (c)(1)(i) to allow for a minimum height of
\3/8\ inch for the lettering that explains the purpose of the ENS sign.
FRA does not believe that this change will adversely impact the safety
of a vehicular operator or passenger. FRA also has made a parallel
modification to paragraph (c)(1)(ii) to distinguish the various letter-
height requirements for the information displayed on the ENS sign.

III. Regulatory Impact

A. Executive Orders 12866 and 13563 and DOT Regulatory Policies and
Procedures

    Prior to issuing the Final Rule, FRA prepared and placed in the
docket a regulatory evaluation addressing the economic impact of the
Final Rule. The rule was evaluated in accordance with existing policies
and procedures and determined to be non-significant under both
Executive Orders 12866 and 13563 and DOT policies and procedures. See
44 FR 11034; February 26, 1979. The present final rule and response to
the AAR Petition is likewise considered to be non-significant under
both Executive Orders 12866 and 13563 and DOT policies and procedures.
This regulatory action generally clarifies, reduces, or makes technical
amendments to the requirements contained in the Final Rule and allows
for greater flexibility in complying with the Final Rule as amended.
    These amendments and clarifications respond to the AAR Petition and
will provide greater flexibility in the implementation of the Final
Rule as amended. In particular, FRA has amended the Final Rule to
eliminate the requirement in Sec.  234.311(a)(2)(ii) to post ENS signs
at each vehicular entrance to a private industrial facility, which will
reduce some costs. FRA also has amended the Final Rule by adding
paragraph (c) to Sec.  234.311, to permit a railroad to replace or
repair an ENS sign within 30 calendar days from the time that the
railroad discovers that the sign is missing or damaged. This was in
response to the AAR Petition and comments from BRS. Generally,
railroads currently replace or repair signs within this timeframe;
therefore, this will not increase the burden on the railroads that
currently have compliant signs. However, for railroads required to
install new signs due to this final rule, the estimated replacement
cost is $76,553 \1\ annually or $1,071,735 over the 15-year period with
a present value (7%) of approximately $625,689. Additionally, FRA has
amended Sec.  234.317(c)(1)(i) in the Final Rule to allow for a minimum
height of \3/8\ inch for the lettering that explains the purpose of the
ENS sign, permitting an estimated 33,000 signs currently in place to be
used for the remainder of their useful life. This change reduced the
costs by approximately $918,035 \2\ with a present value (7%) of
approximately $712,849. In the Final Rule cost estimates, FRA had
inadvertently assumed that these 33,000 signs would have been allowed
under the requirements in the Final Rule, even though, the signs
actually would not have been allowed for their useful life under the
Final Rule requirements. With the new lettering size requirements in
the amendments to the Final Rule, these signs are now permitted to be
used for their useful life. Thus the estimated costs in the Final
Rule's regulatory evaluation reflected the requirements as

modified in these amendments. In summary, FRA has concluded that these
amendments will reduce the costs, but will have a minimal net effect on
FRA's original estimate of the benefits associated with the Final Rule.
For the 15-year period analyzed, the estimated quantified cost that
will be imposed on railroads by the Final Rule as amended by this
action totals $16.6 million, with a present value (PV, 7 percent) of
$10.7 million. FRA estimates that $57.8 million in cost savings will
accrue through casualty prevention and damage avoidance over the 15-
year period, justifying the cost. The discounted value of this is $31.7
million (PV, 7 percent).
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    \1\ Calculation: 3,000 signs per year * [($15 per sign) + (.25
installation labor hours per sign * $42.07 per hour)] = $76,553.
    \2\ Calculation: 33,000 signs * [($15 per sign) + (.25
installation labor hours per sign * $42.07 per hour) + (5% of signs
needing posts * $25 per post) + (5% of signs needing posts * .5
installation labor hours per post * $42.07 per hour)] = $918,035.
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B. Regulatory Flexibility Act and Executive Order 13272

    To ensure potential impacts of rules on small entities are properly
considered, FRA developed this action and the original Final Rule in
accordance with Executive Order 13272 (``Proper Consideration of Small
Entities in Agency Rulemaking'') and DOT's procedures and policies to
promote compliance with the Regulatory Flexibility Act (5 U.S.C. 601 et
seq.). Pursuant to the Regulatory Flexibility Act (5 U.S.C. 605(b)),
FRA certifies that this action would not have a significant economic
impact on a substantial number of small entities.
    ``Small entity'' is defined in 5 U.S.C. 601 (Section 601). Section
601(3) defines the term ``small entity'' as having the same meaning as
``small business concern'' under Section 3 of the Small Business Act.
This includes any small business concern that is independently owned
and operated, and is not dominant in its field of operation. Section
601(4) likewise includes within the definition of ``small entity'' a
not-for-profit enterprise that is independently owned and operated, and
not dominant in its field of operations.
    The U.S. Small Business Administration (SBA) stipulates in its
``Size Standards'' that the largest a railroad business firm that is
``for-profit'' may be, and still be classified as a ``small entity,''
is 1,500 employees for ``Line Haul Operating Railroads'' and 500
employees for ``Switching and Terminal Establishments.'' See ``Size
Eligibility Provisions and Standards,'' 13 CFR part 121, subpart A.
    Federal agencies may adopt their own size standards for small
entities in consultation with SBA, and in conjunction with public
comment. Pursuant to the authority provided to it by SBA, FRA has
published a final policy, which formally establishes small entities as
railroads that meet the line haulage revenue requirements of a Class
III railroad. See 68 FR 24891 (May 9, 2003), codified at Appendix C to
49 CFR part 209. Currently, the revenue requirements are $20 million or
less in annual operating revenue, adjusted annually for inflation. The
$20 million limit (adjusted annually for inflation) is based on the
STB's threshold for a Class III railroad, which is adjusted by applying
the railroad revenue deflator adjustment. For further information on
the calculation of the specific dollar limit, see 49 CFR part 1201. FRA
is using the STB's threshold in its definition of ``small entities''
for this rule.
    The amendments contained in this action may have a minimal, if any,
impact on small entities. FRA expects that any impact these amendments
do have on small entities would be positive because they generally
clarify or reduce the requirements contained in the Final Rule or allow
for greater flexibility in complying with the Final Rule as amended.
Accordingly, FRA has concluded that there are no substantial economic
impacts on small entities resulting from this action.

C. Federalism

    Executive Order 13132, ``Federalism'' (64 FR 43255, Aug. 10, 1999),
requires FRA to develop an accountable process to ensure ``meaningful
and timely input by State and local officials in the development of
regulatory policies that have federalism implications.'' ``Policies
that have federalism implications'' are defined in the Executive Order
to include regulations that have ``substantial direct effects 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.'' Under Executive Order 13132, the agency
may not issue a regulation with federalism implications that imposes
substantial direct compliance costs and that is not required by
statute, unless the Federal government provides the funds necessary to
pay the direct compliance costs incurred by State and local
governments, the agency consults with State and local governments, or
the agency consults with State and local government officials early in
the process of developing the regulation. Where a regulation has
federalism implications and preempts State law, the agency seeks to
consult with State and local officials in the process of developing the
regulation.
    As stated in the preamble to this final rule, FRA has analyzed this
final rule in accordance with the principles and criteria contained in
Executive Order 13132. Accordingly, FRA has determined that this final
rule has no federalism implications, other than the possible preemption
of State laws under Federal railroad safety statutes, specifically 49
U.S.C. 20106. See 76 FR 18083. This final rule and response to the AAR
Petition generally clarifies or reduces the requirements contained in
the rule or allows for greater flexibility in complying with the rule.

D. International Trade Impact Assessment

    The Trade Agreement Act of 1979 prohibits Federal agencies from
engaging in any standards or related activities that create unnecessary
obstacles to the foreign commerce of the United States. Legitimate
domestic objectives, such as safety, are not considered unnecessary
obstacles. The statute also requires consideration of international
standards and where appropriate, that they be the basis for U.S.
standards. This rulemaking is purely domestic in nature and is not
expected to affect trade opportunities for U.S. firms doing business
overseas or for foreign firms doing business in the United States.

E. Paperwork Reduction Act

Paperwork Statement--Emergency Notification System
    The information collection requirements in this final rule and
response to the AAR Petition are being submitted for approval to the
Office of Management and Budget (OMB) under the Paperwork Reduction Act
of 1995, 44 U.S.C. 3501 et seq. The sections of the final rule that
contain the new information collection requirements and the estimated
time to fulfill each requirement are as follows:

----------------------------------------------------------------------------------------------------------------
                                                            Total annual       Average time per    Total annual
       CFR Section/subject         Respondent universe       responses             response        burden hours
----------------------------------------------------------------------------------------------------------------
234.303(b): Receipt by             594 railroads......  63,891 reports.....  1 minute...........           1,065
 Dispatching RR of Report of
 Unsafe Condition at Highway-Rail
 Grade Crossing
234.303(d): Receipt by             594 railroads......  1,860 reports/1,860  1 minute + 1 minute              62
 Dispatching RR of Report of                             records.
 Unsafe Condition at Pathway
 Grade Crossing
234.305(a)(2): Immediate Contact   594 railroads......  465 contacts.......  1 minute...........               8
 by Dispatching RR Not Having
 Maintenance Responsibility of
 All Trains Authorized to Operate
 through That Crossing in
 Response to Credible Report of
 Warning System Malfunction at
 Highway-Rail Grade Crossing
    (a)(2) Contact of Crossing     594 railroads......  465 contacts + 465   1 minute + 1 minute              16
     Maintenance RR by                                   records.
     Dispatching RR Not Having
     Maintenance Responsibility
     in Response to Credible
     Report of Warning System
     Malfunction at Highway-Rail
     Grade Crossing.
    (b)(1) In Response to Public   594 railroads......  925 contacts + 925   1 minute + 1 minute              30
     Report of Warning System                            records.
     Malfunction at Highway-Rail
     Grade Crossing Immediate
     Contact by Dispatching RR
     Having Maintenance Duty for
     Crossing of All Trains
     Authorized to Operate
     Through That Crossing.
    Dispatching RR Having          594 railroads......  925 contacts.......  1 minute...........              15
     Maintenance Duty for
     Crossing Contact of
     Appropriate Law Enforcement
     Authority with Necessary
     Information regarding
     Reported Malfunction.
234.305(b)(2) In Response to       594 railroads......  920 contacts.......  1 minute...........              15
 Public Report of Warning System
 Malfunction at Highway-Rail
 Grade Crossing Immediate Contact
 by Dispatching RR Not Having
 Maintenance Duty for that
 Crossing of All Trains
 Authorized to Operate Through
 That Crossing.
    Dispatching RR Contact of Law  594 railroads......  920 contacts.......  1 minute...........              15
     Enforcement Authority to
     Direct Traffic/Maintain
     Safety.
    Dispatching RR Contact of      594 railroads......  920 contacts + 920   1 minute + 1 minute              30
     Maintaining RR re: Reported                         records.
     Malfunction and Maintaining
     RR Record of Unsafe
     Condition.

234.305(c)(1): In Response to      594 railroads......  2 contacts + 2       1 minute + 1 minute          .06666
 Report of Warning System Failure                        records.
 at Pathway Grade Crossing
 Dispatching RR Having
 Maintenance Duty Contact of All
 Trains Authorized to Operate
 Thru It & Record of Unsafe
 Condition
    In Response to Report of       594 railroads......  2 contacts.........  1 minute...........          .03333
     Warning System Failure at
     Pathway Grade Crossing
     Dispatching RR Having
     Maintenance Duty Contact of
     Law Enforcement Agencies to
     Direct Traffic & Maintain
     Safety.
234.305(d)(1) Upon Receiving       594 railroads......  7,440 contact +      1 minute + 1 minute             248
 Report of Disabled Vehicle or                           7,440 rcds.
 Other Obstruction Dispatching RR
 Having Maintenance Duty Contact
 of All Trains Authorized to
 Operate Through Highway-Rail or
 Pathway Grade Crossing & Record
 of Unsafe Condition.
    Dispatching RR Having          594 railroads......  7,440 contacts.....  1 minute...........             124
     Maintenance Duty Contact of
     Law Enforcement Authority
     Upon Receiving Report of
     Disabled Vehicle or Other
     Obstruction.
    (d)(2) Dispatching RR Not      594 railroads......  2,556 contacts.....  1 minute...........              43
     Having Maintenance Duty
     Contact of All Trains
     Authorized to Operate
     through Highway-Rail or
     Pathway Grade Crossing After
     Report of Disabled Vehicle
     or Other Unsafe Condition.
    Dispatching RR Not Having      594 railroads......  2,556 contacts.....  1 minute...........              43
     Maintenance Responsibility
     Contact of Law Enforcement
     Authority regarding Disabled
     Vehicle/Unsafe Condition.
    Dispatching RR Contact of      594 railroads......  2,556 contacts +     1 minute + 1 minute              86
     Maintaining RR regarding                            2,556 records.
     Unsafe Condition at Crossing
     & Record of Unsafe Condition.
234.305(h): Provision of Contact   594 railroads......  10 info. contacts..  1 minute...........           .1667
 Information by Maintaining RR to
 Dispatching RR in Order to Be
 Contacted regarding Reports of
 Unsafe Conditions at Highway-
 Rail and Pathway Grade Crossings

234.306(a): Appointment of One     594 railroads......  50 appointments &    60 minutes.........              50
 Dispatching RR as Primary                               records.
 Dispatching RR Where Multiple
 RRs Dispatch Trains through Same
 Highway-Rail or Pathway Grade
 Crossing to Provide Info. for
 ENS Sign
    (b): Appointment of One        594 railroads......  50 appointments &    60 minutes.........              50
     Maintaining RR As Primary                           records.
     Maintaining RR Where
     Multiple RRs Maintain Same
     Highway-Rail or Pathway
     Grade Crossing for Placement
     and Maintenance of ENS Sign.
234.307(b): 3rd Party Telephone    594 railroads......  50 reports + 50      1 minute + 1 minute               2
 Service Report of Unsafe                                records.
 Conditions at Highway-Rail or
 Pathway Grade Crossings to
 Maintaining Railroad and
 Maintaining RR Record of Unsafe
 Condition
    (c)--3rd Party Telephone       594 railroads......  50 reports.........  1 minute...........               1
     Service Report to
     Dispatching RR of Unsafe
     Condition.
    (d)(1)--Provision of Contact   594 railroads......  17 contact calls...  15 minutes.........               4
     Information to 3rd Party
     Telephone Service by
     Dispatching RR or
     Maintaining RR Using That
     Service to Receive Reports
     of Unsafe Conditions at
     Highway-Rail or Pathway
     Grade Crossings.
    (d)(2):--Written Notice to     594 railroads......  17 letters.........  60 minutes.........              17
     FRA by Railroad of Intent to
     Use 3rd Party Svc..
    (d)(3)--Railroad Written       594 railroads......  5 letters..........  60 minutes.........               5
     Notification to FRA of Any
     Changes in Use or
     Discontinuance of 3rd Party
     Service.
234.309(a): ENS Signs--General
    Provision of ENS Telephone     594 railroads......  81,948 signs.......  30 minutes.........          40,974
     Number to Maintaining RR by
     Dispatching RR If Two RRs
     Are Not the Same.
    (b) ENS Signs Located at       594 railroads......  10 contacts........  30 minutes.........               5
     Highway-Rail or Pathway
     Grade Crossings as required
     by Sec.   234.311 with
     Necessary Information to
     Receive Reports Required
     under Sec.   234.303.
234.311(c): Repair or replacement  594 railroads......  4,000 signs........  15 minutes.........           1,000
 of ENS Signs after discovery by
 responsible railroad of a
 missing, damaged, or otherwise
 unusable/illegible sign to
 vehicular/pedestrian traffic
 (New)
234.313: Recordkeeping

    Records of Reported Unsafe     594 railroads......  186,000 records....  4 minutes..........          12,400
     Conditions Pursuant to Sec.
      234.303.
----------------------------------------------------------------------------------------------------------------

    All estimates include the time for reviewing instructions;
searching existing data sources; gathering or maintaining the needed
data; and reviewing the information. For information or a copy of the
paperwork package submitted to OMB, contact Mr. Robert Brogan at 202-
493-6292 or Ms. Kimberly Toone at<PHONE_NUMBER> or via email at the
following addresses<EMAIL_ADDRESS><EMAIL_ADDRESS>    Organizations and individuals desiring to submit comments on the
collection of information requirements should direct them to the Office
of Management and Budget, Office of Information and Regulatory Affairs,
Washington, DC 20503, Attention: FRA Desk Officer. Comments may also be
sent via email to OMB at the following address<EMAIL_ADDRESS>    OMB is required to make a decision concerning the collection of
information requirements contained in this final rule between 30 and 60
days after publication of this document in the Federal Register.
Therefore, a comment to OMB is best assured of having its full effect
if OMB receives it within 30 days of publication.
    FRA is not permitted to impose a penalty on persons for violating
information collection requirements which do not display a current OMB
control number, if required. FRA intends to obtain current OMB control
numbers for any new information collection requirements resulting from
this rulemaking action prior to the effective date of this final rule.
The OMB control number, when assigned, will be announced by separate
notice in the Federal Register.

F. Environmental Assessment

    FRA has evaluated the present final rule in accordance with its
``Procedures for Considering Environmental Impacts'' (FRA's Procedures)
(64 FR 28545, May 26, 1999) as required by the National Environmental
Policy Act (42 U.S.C. 4321 et seq.), other environmental statutes,
Executive Orders, and related regulatory requirements. FRA has
determined that this final rule is not a major FRA action (requiring
the preparation of an environmental impact statement or environmental
assessment) because it is categorically excluded from detailed
environmental review pursuant to section 4(c)(20) of FRA's Procedures.
(See 64 FR 28547, May 26, 1999.) Section 4(c)(20) reads as follows:
``Actions categorically excluded. Certain classes of FRA actions have
been determined to be categorically excluded from the requirements of
these Procedures as they do not individually or cumulatively have a
significant effect on the human environment. * * * The following
classes of FRA actions are categorically excluded: * * * Promulgation
of railroad safety rules and policy statements that do not result in
significantly increased emissions or air or water pollutants or noise
or increased traffic congestion in any mode of transportation.''
    In accordance with section 4(c) and (e) of FRA's Procedures, the
agency has further concluded that no extraordinary circumstances exist
with respect to this regulation that might trigger the need for a more
detailed environmental review. As a result, FRA finds that this final
rule is not a major Federal action significantly affecting the quality
of the human environment.

G. Unfunded Mandates Reform Act of 1995

    Pursuant to Section 201 of the Unfunded Mandates Reform Act of 1995
(Pub. L. 104-4, 2 U.S.C. 1531), each Federal agency ``shall, unless
otherwise prohibited by law, assess the effects of Federal regulatory
actions on State, local, and tribal governments, and the private sector
(other than to the extent that such regulations incorporate
requirements specifically set forth in law).'' Section 202 of the Act
(2 U.S.C. 1532) further requires that ``before promulgating any general
notice of proposed rulemaking that is likely to result in the
promulgation of any rule that includes any Federal mandate that may
result in expenditure by State, local, and tribal governments, in the
aggregate, or by the private sector, of $100 million or more (adjusted
annually for inflation) [$140,800,000 or more in 2010] in any one year,
and before promulgating any final rule for which a general notice of
proposed rulemaking was published, the agency shall prepare a written
statement'' detailing the effect on State, local, and tribal
governments and the private sector. This final rule and response to the
AAR Petition will not result in the expenditure, in the aggregate, of
more than $140,800,000 or more in any one year, and thus preparation of
such a statement is not required.

H. Energy Impact

    Executive Order 13211 requires Federal agencies to prepare a
Statement of Energy Effects for any ``significant energy action.'' 66
FR 28355 (May 22, 2001). Under the Executive Order, a ``significant
energy action'' is defined as any action by an agency (normally
published in the Federal Register) that promulgates, or is expected to
lead to the promulgation of, a final rule or regulation, including
notices of inquiry, advance notices of proposed rulemaking, and notices
of proposed rulemaking: (1)(i) That is a significant regulatory action
under Executive Order 12866 or any successor order, and (ii) is likely
to have a significant adverse effect on the supply, distribution, or
use of energy; or (2) is designated by the Administrator of the Office
of Information and Regulatory Affairs as a significant energy action.
FRA has evaluated this final rule and response to the AAR Petition in
accordance with Executive Order 13211. FRA has determined that this
final rule will not have a significant adverse effect on the supply,
distribution, or use of energy. Consequently, FRA has determined that
this regulatory action is not a ``significant energy action'' within
the meaning of Executive Order 13211.

I. Privacy Act Statement

    Interested parties should be aware that anyone is able to search
the electronic form of all comments received into any agency docket by
the name of the individual submitting the comment (or signing the
comment, if submitted on behalf of an association, business, labor
union, etc.). You may review DOT's complete Privacy Act Statement in
the Federal Register published on April 11, 2000 (Volume 65, Number 70;
Pages 19477-78), or you may visit http://www.regulations.gov.

List of Subjects in 49 CFR Part 234

    Highway safety, Penalties, Railroad safety, and Reporting and
recordkeeping requirements, State and local governments.

The Final Rule

    In consideration of the foregoing, FRA amends part 234 of chapter
II, subtitle B of title 49, Code of Federal Regulations, as follows:

PART 234--GRADE CROSSING SAFETY, INCLUDING SIGNAL SYSTEMS, STATE
ACTION PLANS, AND EMERGENCY NOTIFICATION SYSTEMS

0
1. The authority citation for part 234 is revised to read as follows:

    Authority:  49 U.S.C. 20103, 20107, 20152, 21301, 21304, 21311,
22501 note; Pub. L. 110-432, Div. A, Secs. 202, 205; 28 U.S.C. 2461,
note; and 49 CFR 1.89.

0
2. Section 234.311 is amended by revising paragraph (a)(2)(ii) and
adding paragraph (c), to read as follows:

Sec.  234.311  ENS sign placement and maintenance.

    (a) * * *
    (2) * * *
    (ii) At a railroad yard, or a port or dock facility that does not
meet the definition of ``plant railroad'' in Sec.  234.5, the
responsible railroad shall place and maintain a minimum of one sign at
each vehicular entrance to the yard, or the port or dock facility in
accordance with Sec.  234.309, in lieu of placing signs at each
crossing within the yard, or the port or dock facility. Each sign must
be placed so that it is clearly visible to a driver of a motor vehicle
located at the vehicular entrance to the yard, or the port or dock
facility.
* * * * *
    (c) Repair or replacement of ENS sign. If an ENS sign required by
this subpart is discovered by the responsible railroad to be missing,
damaged, or in any other way unusable to vehicular or pedestrian
traffic, the responsible railroad shall repair or replace the sign no
later than 30 calendar days from the time of detection.

0
3. Section 234.317 is amended by revising paragraphs (b), (c)(1)(i) and
(ii), and (e) to read as follows:

Sec.  234.317  Compliance dates.

* * * * *
    (b) Railroads with nonconforming ENS telephone service. If a
railroad subject to this subpart already has its own ENS telephone
service or is using a third-party ENS telephone service, and that
telephone service does not conform to the requirements in Sec.  234.303
or Sec.  234.307, respectively, on August 13, 2012, the railroad shall
comply with this subpart no later than March 1, 2014, pursuant to the
exceptions in paragraphs (c), (d), and (e) of Sec.  234.317.
    (c) * * *
    (1) * * *
    (i) If the railroad's sign size is greater than or equal to 60
square inches and the height of the lettering on the sign is greater
than or equal to \3/4\ inch for the information required in Sec.
234.309(b)(1) and (b)(3), and greater than or equal to \3/8\ inch for
the information required in Sec.  234.309(b)(2) on August 13, 2012, the
railroad may maintain the sign for its useful life.
    (ii) If the railroad's sign size is greater than or equal to 60
square inches but the height of the lettering is either less than \3/4\
inch for the information required in Sec.  234.309(b)(1) and (b)(3), or
less than \3/8\ inch for the information required in Sec.
234.309(b)(2) on August 13, 2012, the railroad's sign must conform to
Sec.  234.309 no later than September 1, 2017.
* * * * *
    (e) Railroads with nonconforming ENS recordkeeping. If a railroad
subject to this subpart already conducts recordkeeping as part of its
ENS, and that recordkeeping does not conform to Sec.  234.313 or Sec.
234.315, the railroad's recordkeeping shall conform to Sec.  234.313 or
Sec.  234.315 no later than March 1, 2014.

    Issued in Washington, DC, on March 11, 2013.
Joseph C. Szabo,
Administrator, Federal Railroad Administration.
[FR Doc. 2013-06083 Filed 3-14-13; 8:45 am]
BILLING CODE 4910-06-P


[Federal Register Volume 77, Number 30 (Tuesday, February 14, 2012)]
[Notices]
[Pages 8260-8262]
[FR Doc No: 2012-3344]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0110]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Medical Device Reporting: Manufacturer, Importer, User
Facility, and Distributor Reporting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is announcing an
opportunity for public comment on the proposed collection of certain
information by the Agency. Under the Paperwork Reduction Act of 1995
(the PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed extension of an existing
collection of information, and to allow 60 days for public comment in
response to the notice. This notice solicits comments on medical device
reporting (MDR); manufacturer, importer, user facility, and distributor
reporting.

DATES: Submit either electronic or written comments on the collection
of information by April 16, 2012.

ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. Submit written comments on the
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. All comments should be identified with the docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information before
submitting the collection to OMB for approval. To comply with this
requirement, FDA is publishing notice of the proposed collection of
information set forth in this document.
    With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and

assumptions used; (3) ways to enhance the quality, utility, and clarity
of the information to be collected; and (4) ways to minimize the burden
of the collection of information on respondents, including through the
use of automated collection techniques, when appropriate, and other
forms of information technology.

Medical Device Reporting: Manufacturer, Importer, User Facility, and
Distributor Reporting--21 CFR Part 803 (OMB Control Number 0910-0437)--
Extension

    Section 519(a)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C
Act) (21 U.S.C. 360i(a)(1)) requires every manufacturer or importer to
report ``whenever the manufacturer or importer receives or otherwise
becomes aware of information that reasonably suggests that one of its
marketed devices: (A) May have caused or contributed to a death or
serious injury, or (B) has malfunctioned and that such device or a
similar device marketed by the manufacturer or importer would be likely
to cause or contribute to a death or serious injury if the malfunction
were to recur.''
    Section 519(b)(1)(A) of the FD&C Act requires ``whenever a device
user facility receives or otherwise becomes aware of information that
reasonably suggests that a device has or may have caused or contributed
to the death or serious illness, of a patient of the facility, the
facility shall, as soon as practicable but not later than 10 working
days after becoming aware of the information, report the information to
the Secretary and, if the identity of the manufacturer is known, to the
manufacturer of the device.''
    Section 519(b)(1)(B) of the FD&C Act requires ``whenever a device
user facility receives or otherwise becomes aware of: (i) Information
that reasonably suggests that a device has or may have caused or
contributed to the serious illness of, or serious injury to, a patient
of the facility * * *, shall, as soon as practicable but not later than
10 working days after becoming aware of the information, report the
information to the manufacturer of the device or to the Secretary if
the identity of the manufacturer is not known.''
    Complete, accurate, and timely adverse event information is
necessary for the identification of emerging device problems.
Information from these reports will be used to evaluate risks
associated with medical devices which will enable FDA to take
appropriate regulatory measures in protection of the public health
under section 519 of the FD&C Act. Thus FDA is requesting approval for
these information collection requirements which are being implemented
under part 803 (21 CFR part 803).
    Respondents to this collection of information are businesses or
other for-profit and nonprofit organizations including user facilities,
manufacturers, and importers of medical devices.
    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of
  21 CFR section/ form FDA No.       Number of     responses per   Total annual   Average burden    Total hours
                                    respondents     respondent       responses     per response
----------------------------------------------------------------------------------------------------------------
803.19..........................              57               4             228               3             684
803.30 and .32..................             393               2             777               1             777
803.33 Form FDA 3419............             393               1             393               1             393
803.40 and .42..................              73              37           2,682               1           2,682
803.50 and .52..................           1,601             104         166,271               1         166,271
803.56..........................           1,200              63          76,186               1          76,186
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............         246,993
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

                                                   Table 2--Estimated Annual Recordkeeping Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Number of                        Average  burden
                        21 CFR section                              Number of        records per      Total annual           per           Total hours
                                                                  recordkeepers     recordkeeper         records        recordkeeping
--------------------------------------------------------------------------------------------------------------------------------------------------------
803.17........................................................               220                 1               220                10             2,200
803.18 (c) & (d)..............................................            30,000                 1            30,000               1.5            45,000
                                                               -----------------------------------------------------------------------------------------
    Total.....................................................  ................  ................  ................  ................            47,200
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Part 803 requires user facilities to report to the device
manufacturer and to FDA in case of a death, incidents where a medical
device caused or contributed to a death or serious injury.
Additionally, user facilities are required to annually submit the
number and summary of advents reported during the calendar year, using
Form FDA 3419. Manufacturers of medical devices are required to report
to FDA when they become aware of information indicating that one of
their devices may have caused or contributed to death or serious injury
or has malfunctioned in such a way that should the malfunction recur it
would be likely to cause or contribute to a death or serious injury.
Device importers report deaths and serious injuries to the
manufacturers and FDA. Importers report malfunctions only to the
manufacturers, unless they are unknown, then the reports are sent to
FDA.
    The number of respondents for each CFR section in table 1 of this
document is based upon the number of respondents entered into FDA's
internal databases. FDA estimates, based on its experience and
interaction with the medical device community, that all reporting CFR
sections are expected to take 1 hour to complete, with the exception of
Sec.  803.19. Section 803.19 is expected to take approximately 3 hours
to complete, but is only required for reporting the summarized data
quarterly to FDA. By summarizing events, the total time used to report
for this section

is reduced because the respondents do not submit a full report for each
event they report in a quarterly summary report.
    The Agency believes that the majority of manufacturers, user
facilities, and importers have already established written procedures
to document complaints and information to meet the MDR requirements as
part of their internal quality control system. There are an estimated
30,000 medical device distributors. Although they do not submit MDR
reports, they must maintain records of complaints, under Sec.
803.18(d).
    The Agency has estimated that on average 220 user facilities,
importers, and manufacturers would annually be required to establish
new procedures, or revise existing procedures, in order to comply with
this provision.
    Therefore, FDA estimates the one-time burden to respondents for
establishing or revising procedures under Sec.  803.17 to be 2,200
hours (220 respondents x 10 hours). For those entities, a one-time
burden of 10 hours is estimated for establishing written MDR
procedures. The remaining manufacturers, user facilities, and
importers, not required to revise their written procedures to comply
with this provision, are excluded from the burden because the
recordkeeping activities needed to comply with this provision are
considered ``usual and customary'' under 5 CFR 1320.3(b)(2).
    Under Sec.  803.18, 30,000 respondents represent distributors,
importers, and other respondents to this information collection. FDA
estimates that it should take them approximately 1.5 hours to complete
the recordkeeping requirement for this section. Total hours for this
section equal 45,000 hours.

    Dated: February 9, 2012.
Leslie Kux,
Acting Assistant Commissioner for Policy.
[FR Doc. 2012-3344 Filed 2-13-12; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 84, Number 110 (Friday, June 7, 2019)]
[Rules and Regulations]
[Pages 26558-26559]
[FR Doc No: 2019-11898]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 71

[Docket No. FAA-2019-0206; Airspace Docket No. 19-ASO-6]
RIN 2120-AA66

Amendment of Class E Airspace; Monroe, GA

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

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SUMMARY: This action amends Class E airspace extending upward from 700
feet above the surface in Monroe-Walton County Airport, Monroe, GA, to
accommodate airspace reconfiguration due to the decommissioning of the
Monroe non-directional radio beacon and cancellation of the NDB
approach. Controlled airspace is necessary for the safety and
management of instrument flight rules (IFR) operations at this airport.
This action also updates the geographic coordinates of this airport.

DATES: Effective 0901 UTC, August 15, 2019. The Director of the Federal
Register approves this incorporation by reference action under Title 1
Code of Federal Regulations part 51, subject to the annual revision of
FAA Order 7400.11 and publication of conforming amendments.

ADDRESSES: FAA Order 7400.11C, Airspace Designations and Reporting
Points, and subsequent amendments can be viewed on line at http://www.faa.gov/air_traffic/publications/. For further information, you can
contact the Airspace Policy Group, Federal Aviation Administration, 800
Independence Avenue SW, Washington, DC 20591; telephone: (202) 267-
8783. The Order is also available for inspection at the National
Archives and Records Administration (NARA). For information on the
availability of FAA Order 7400.11C at NARA, call<PHONE_NUMBER>, or go
to https://www.archives.gov/federal-register/cfr/ibr-locations.html.
    FAA Order 7400.11, Airspace Designations and Reporting Points, is
published yearly and effective on September 15.

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

SUPPLEMENTARY INFORMATION:

Authority for This Rulemaking

    The FAA's authority to issue rules regarding aviation safety is
found in Title 49 of the United States Code. Subtitle I, Section 106
describes the authority of the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more detail the scope of the agency's
authority. This rulemaking is promulgated under the authority described
in Subtitle VII, Part A, Subpart I, Section 40103. Under that section,
the FAA is charged with prescribing regulations to assign the use of
airspace necessary to ensure the safety of aircraft and the efficient
use of airspace. This regulation is within the scope of that authority
as it amends Class E airspace extending upward from 700 feet above the
surface for Monroe-Walton County Airport, Monroe, GA, due to the
decommissioning of the Monroe non-directional radio beacon and
cancellation of the NDB approach.

History

    The FAA published a notice of proposed rulemaking in the Federal
Register (84 FR 13575, April 5, 2019) for Docket No. FAA-2019-0206 to
amend Class E airspace extending upward from 700 feet above the surface
for Monroe-Walton County Airport, Monroe, GA, due to the
decommissioning of the Monroe NDB and cancellation of the NDB approach.
    Interested parties were invited to participate in this rulemaking
effort by submitting written comments on the proposal to the FAA. No
comments were received.
    Class E airspace designations are published in Paragraph 6005 of
FAA Order 7400.11C, dated August 13, 2018, and effective September 15,
2018, which is incorporated by reference in 14 CFR part 71.1. The Class
E airspace designation listed in this document will be published
subsequently in the Order.

Availability and Summary of Documents for Incorporation by Reference

    This document amends FAA Order 7400.11C, Airspace Designations and
Reporting Points, dated August 13, 2018, and effective September 15,
2018. FAA Order 7400.11C is publicly available as listed in the
ADDRESSES section of this document. FAA Order 7400.11C lists Class A,
B, C, D, and E airspace areas, air traffic service routes, and
reporting points.

The Rule

    This amendment to Title 14 Code of Federal Regulations (14 CFR)
part 71 amends Class E airspace extending upward from 700 feet above
the surface at Monroe-Walton County Airport, Monroe, GA, by increasing
the airport radius to 6.9 miles (from 6.3 miles), and eliminating the
southwest extension of the airport to accommodate airspace
reconfiguration due to the decommissioning of the Monroe NDB and
cancellation of the NDB approach. Also, the geographic coordinates of
the airport are adjusted to coincide with the FAA's aeronautical
database. These changes are necessary for continued safety and
management of IFR operations at this airport.

Regulatory Notices and Analyses

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

Environmental Review

    The FAA has determined that this action qualifies for categorical
exclusion under the National Environmental Policy Act in accordance
with FAA Order 1050.1F, ``Environmental Impacts: Policies and
Procedures,'' paragraph 5-6.5a. This airspace action is not expected to
cause any potentially significant environmental impacts, and no
extraordinary circumstances exist that warrant preparation of an
environmental assessment.

Lists of Subjects in 14 CFR Part 71

    Airspace, Incorporation by reference, Navigation (air).

Adoption of the Amendment

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

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

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

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

Sec.  71.1   [Amended]

0
2. The incorporation by reference in 14 CFR 71.1 of FAA Order 7400.11C,
Airspace Designations and Reporting Points, dated August 13, 2018,
effective September 15, 2018, is amended as follows:

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

* * * * *

ASO GA E5 Monroe, GA [Amended]

Monroe-Walton County Airport, GA
    (Lat. 33[deg]46'57'' N, long. 83[deg]41'34'' W)

    That airspace extending upward from 700 feet above the surface
within a 6.9-mile radius of the Monroe-County Airport.

    Issued in College Park, Georgia, on May 31, 2019.
Ryan Almasy,
Manager Operations Support Group, Eastern Service Center, Air Traffic
Organization.
[FR Doc. 2019-11898 Filed 6-6-19; 8:45 am]
 BILLING CODE 4910-13-P


[Federal Register Volume 76, Number 166 (Friday, August 26, 2011)]
[Proposed Rules]
[Pages 53371-53372]
[FR Doc No: 2011-21726]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 60 and 63

[EPA-HQ-OAR-2010-0505; FRL-9456-2]
RIN 2060-AP76

Oil and Natural Gas Sector: New Source Performance Standards and
National Emission Standards for Hazardous Air Pollutants Reviews

AGENCY: Environmental Protection Agency (EPA).

ACTION: Proposed rule; Announcement of public hearings.

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SUMMARY: The EPA published in the Federal Register on August 23, 2011,
the proposed rule, ``Oil and Natural Gas Sector: New Source Performance
Standards and National Emission Standards for Hazardous Air Pollutants
Reviews.'' The EPA is announcing three public hearings to be held for
the proposed rule.

DATES: The public hearings will be held on September 27, 2011,
September 28, 2011, and September 29, 2011.

ADDRESSES: The public hearings will be held on September 27, 2011, in
Pittsburgh, Pennsylvania, September 28, 2011, in Denver, Colorado, and
September 29, 2011, in Arlington, Texas. The September 27, 2011, public
hearing will be held at the David L. Lawrence Convention Center in
Rooms 315-316, located at 1000 Ft. Duquesne Blvd., Pittsburgh,
Pennsylvania 15222; telephone:<PHONE_NUMBER>. The September 28, 2011,
public hearing will be held at the Colorado Convention Center in Room
207, located at 700 14th Street, Denver, Colorado 80202; telephone:
(303) 228-8000. The September 29, 2011, public hearing will be held at
the Arlington Municipal Building in the City Council Chambers located
at 101 W. Abram Street, Arlington, Texas 76010; telephone: (817) 459-
6122.
    The three public hearings will convene at 9 a.m. and will continue
until 8 p.m. (local time). The EPA will make every effort to
accommodate all speakers that arrive and register before 8 p.m. A lunch
break is scheduled from 12:30 p.m. until 2 p.m. and a dinner break is
scheduled from 5 p.m. until 6:30 p.m. The EPA's Web site for the
rulemaking, which includes the proposal and information about the
hearings, can be found at: http://www.epa.gov/airquality/oilandgas/.

FOR FURTHER INFORMATION CONTACT: If you would like to present oral
testimony at the public hearing, please contact Ms. Joan C. Rogers,
U.S. Environmental Protection Agency, Office of Air Quality Planning
and Standards, Sector Policies and Programs Division (E143-03),
Research Triangle Park, North Carolina 27711; telephone: (919) 541-
4487; fax number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>(preferred method for registering), no later than by 4 p.m. (Eastern
Standard Time), 2 business days prior to each hearing. The last day to
register to present oral testimony in advance will be Friday, September
23, 2011, for the Pittsburgh, Pennsylvania, public hearing; Monday,
September 26, 2011, for the Denver, Colorado, public hearing; and
Tuesday, September 27, 2011, for the Arlington, Texas, public hearing.
If using e-mail, please provide the following information: The time you
wish to speak (morning, afternoon or evening), name, affiliation,
address, e-mail address and telephone and fax numbers. Time slot
preferences will be given in the order requests are received. Requests
to speak will be taken the day of each of the hearings at the hearing
registration desk, although preferences on speaking times may not be
able to be fulfilled. If you will require the service of a translator,
please let us know at the time of registration.
    Questions concerning the August 23, 2011 (76 FR 52738), proposed
rule should be addressed to Bruce Moore, Office of Air Quality Planning
and Standards, Sector Policies and Programs Division (E143-05),
Environmental Protection Agency, Research Triangle Park, North Carolina
27711; telephone number:<PHONE_NUMBER>; facsimile number: (919) 541-
3470; e-mail address<EMAIL_ADDRESS>    Public hearing: The proposal for which the EPA is holding the
public hearings was published in the Federal Register on Tuesday,
August 23, 2011 (76 FR 52738), and is available at: http://www.epa.gov/airquality/oilandgas/ and also in the docket identified below. The
public hearings will provide interested parties the opportunity to
present oral comments regarding the EPA's proposed standards, including
data, views or arguments concerning the proposal. The EPA may ask
clarifying questions during the oral presentations, but will not
respond to the presentations at that time. Written statements and
supporting information submitted during the comment period will be
considered with the same weight as any oral comments and supporting
information presented at the public hearing.
    Commenters should notify Ms. Rogers if they will need specific
equipment or if there are other special needs related to providing
comments at the public hearings. The EPA will provide

equipment for commenters to show overhead slides or make computerized
slide presentations if we receive special requests in advance. Oral
testimony will be limited to 5 minutes for each commenter. The EPA
encourages commenters to provide the EPA with a copy of their oral
testimony electronically (via e-mail or CD) or in hard copy form.
    The public hearing schedules, including lists of speakers, will be
posted on the EPA's Web site at http://www.epa.gov/airquality/oilandgas/. Verbatim transcripts of the hearings and written statements
will be included in the docket for the rulemaking. The EPA will make
every effort to follow the schedule as closely as possible on the day
of the hearings; however, please plan for the hearing to run either
ahead of schedule or behind schedule.

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

    The EPA has established a docket for the proposed rule, ``Oil and
Natural Gas Sector: New Source Performance Standards and National
Emission Standards for Hazardous Air Pollutants Reviews,'' under No.
EPA-HQ-OAR-2010-0505, available at http://www.regulations.gov.

List of Subjects

40 CFR Part 60

    Environmental protection, Administrative practice and procedure,
Air pollution control, Intergovernmental relations, Reporting and
recordkeeping requirements.

40 CFR Part 63

    Environmental protection, Administrative practice and procedure,
Air pollution control, Hazardous substances, Intergovernmental
relations, Reporting and recordkeeping requirements.

    Dated: August 19, 2011.
Mary Henigin,
Acting Director, Office of Air Quality Planning and Standards.
[FR Doc. 2011-21726 Filed 8-25-11; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: March 15, 2007 (Volume 72, Number 50)]
[Notices]
[Page 12172-12173]
[DOCID:fr15mr07-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

Notice of Application Accepted for Filing and Soliciting Motions
To Intervene and Protests

March 9, 2007.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: New Major License.
    b. Project No.: 2242-078.
    c. Date Filed: November 24, 2006.
    d. Applicant: Eugene Water and Electric Board.
    e. Name of Project: Carmen-Smith Hydroelectric Project.
    f. Location: On the McKenzie River in Lane and Linn Counties, near
McKenzie Bridge, Oregon. The project occupies approximately 560 acres
of the Willamette National Forest.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Randy L. Berggren, General Manager, Eugene
Water and Electric Board, 500 East 4th Avenue, P.O. Box 10148, Eugene,
OR 97440,<PHONE_NUMBER>.
    i. FERC Contact: Bob Easton,<PHONE_NUMBER> or
<EMAIL_ADDRESS>
    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Philis J. Posey, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Motions to intervene and protests may be filed electronically via
the Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov) under the ``e-

Filing'' link.
    k. This application has been accepted, but is not ready for
environmental analysis at this time.
    l. The Carmen-Smith Hydroelectric Project consists of two
developments, the Carmen development and the Trail Bridge development.
The Carmen development includes: (1) A 25-foot-high, 2,100-foot-long,
and 10-foot-wide earthen Carmen diversion dam with a concrete weir
spillway, (2) a 11,380-foot-long by 9.5-foot-diameter concrete Carmen
diversion tunnel located on the right abutment of the spillway, (3) a
235-foot-high, 1,100-foot-long, and 15-foot-wide earthen Smith
diversion dam with a gated Ogee spillway, (4) a 7,275-foot-long by 13.5
foot-diameter concrete-lined Smith power tunnel, (5) a 1,160-foot-long
by 13-foot-diameter steel underground Carmen penstock, (6) a 86-foot-
long by 79-foot-wide Carmen powerhouse, (7) two Francis turbines each
with a generating capacity of 52.25 megawatts (MW) for a total capacity
of 104.50 MW, (8) a 19-mile, 115-kilovolt (kV) transmission line that
connects the Carmen powerhouse to the Bonneville Power Administration's
Cougar-Eugene transmission line, and (9) appurtenant facilities.
    The Trail Bridge development includes: (1) A 100-foot-high, 700-
foot-long, and 24-foot-wide earthen Trail Bridge dam section with a
gated Ogee spillway, (2) a 1,000-foot-long and 20-foot-wide emergency
spillway section, (3) a 300-foot-long by 12-foot-diameter concrete
penstock at the intake that narrows to a diameter of 7 feet, (4) a 66-
foot-long by 61-foot-wide Trail Bridge powerhouse, (5) one Kaplan
turbine with a generating capacity of 9.975 MW, and (6) a one-mile,
11.5-kV distribution line that connects the Trail Bridge powerhouse to
the Carmen powerhouse.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may be viewed on the
Commission's Web site at http://www.ferc.gov using the ``eLibrary''

link. Enter the docket number excluding the last three digits in the
docket number field to access the document. For assistance, contact
FERC Online Support at<EMAIL_ADDRESS>or toll-free at 1-
866-208-3676, or for TTY,<PHONE_NUMBER>. A copy is also available for
inspection and reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/esubscription.asp
 to be notified via e-mail of new filings and

issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests filed, but
only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any protests
or motions to intervene must be received on or before the specified
deadline date for the particular application.
    All filings must (1) Bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (2) set forth in the heading
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each

representative of the applicant specified in the particular
application.

Philis J. Posey,
Acting Secretary.
[FR Doc. E7-4717 Filed 3-14-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 78, Number 215 (Wednesday, November 6, 2013)]
[Notices]
[Page 66801]
[FR Doc No: 2013-26545]

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

Federal Motor Carrier Safety Administration

[Docket No. FMCSA-2006-26367]

Motor Carrier Safety Advisory Committee; Charter Renewal

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

ACTION: Announcement of advisory committee charter renewal.

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SUMMARY: FMCSA announces the charter renewal of the MCSAC, a Federal
Advisory Committee that provides the Agency with advice and
recommendations on motor carrier safety programs and motor carrier
safety regulations through a consensus process. This charter renewal
will took effect on October 1, 2013, and will expire after 2 years.

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>
SUPPLEMENTARY INFORMATION: Pursuant to Section 10(a)(2) of the Federal
Advisory Committee Act (Pub. L. 92-463), FMCSA is giving notice of the
charter renewal for the MCSAC. The MCSAC was established to provide
FMCSA with advice and recommendations on motor carrier safety programs
and motor carrier safety regulations.
    The MCSAC is composed of 20 voting representatives from safety
advocacy, safety enforcement, labor, and industry stakeholders of motor
carrier safety. The diversity of the Committee ensures the requisite
range of views and expertise necessary to discharge its
responsibilities. The Committee operates as a discretionary committee
under the authority of the U.S. Department of Transportation (DOT),
established in accordance with the provisions of the Federal Advisory
Committee Act (FACA), as amended, 5 U.S.C. App. 2. See FMCSA's MCSAC
Web site for additional information about the committees activities at
http://mcsac.fmcsa.dot.gov/.

    Issued on: October 31, 2013.
Larry W. Minor,
Associate Administrator for Policy.
[FR Doc. 2013-26545 Filed 11-5-13; 8:45 am]
BILLING CODE 4910-EX-P


[Federal Register: June 23, 2008 (Volume 73, Number 121)]
[Notices]
[Page 35402]
[DOCID:fr23jn08-54]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0184]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Temporary Marketing
Permit Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

DATES: Fax written comments on the collection of information by July
23, 2008.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-0133. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Temporary Marketing Permit Applications--21 CFR 130.17(c) and (i)--(OMB
Control Number 0910-0133)--Extension

    Section 401 of the Federal Food, Drug, and Cosmetic Act (the act)
(21 U.S.C. 341), directs FDA to issue regulations establishing
definitions and standards of identity for food ``[w]henever * * * such
action will promote honesty and fair dealing in the interest of
consumers * * *.'' Under section 403(g) of the act (21 U.S.C. 343(g)),
a food that is subject to a definition and standard of identity
prescribed by regulation is misbranded if it does not conform to such
definition and standard of identity. Section 130.17 (21 CFR 130.17)
provides for the issuance by FDA of temporary marketing permits that
enable the food industry to test consumer acceptance and measure the
technological and commercial feasibility in interstate commerce of
experimental packs of food that deviate from applicable definitions and
standards of identity. Section 130.17(c) enables the agency to monitor
the manufacture, labeling, and distribution of experimental packs of
food that deviate from applicable definitions and standards of
identity. The information so obtained can be used in support of a
petition to establish or amend the applicable definition or standard of
identity to provide for the variations. Section 130.17(i) specifies the
information that a firm must submit to FDA to obtain an extension of a
temporary marketing permit.
    In the Federal Register of April 2, 2008 (73 FR 17986), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
130.17(c)                                                              13                     2                 26                 25                650
--------------------------------------------------------------------------------------------------------------------------------------------------------
130.17 (i)                                                              1                     2                  2                  2                  4
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                654
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The estimated number of temporary marketing permit applications and
hours per response is an average based on the agency's experience with
applications received October 1, 2004, through September 30, 2007, and
information from firms that have submitted recent requests for
temporary marketing permits.

    Dated: June 17, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-14151 Filed 6-20-08; 8:45 am]

BILLING CODE 4160-01-S