[Federal Register Volume 88, Number 190 (Tuesday, October 3, 2023)]
[Rules and Regulations]
[Pages 67950-67953]
[FR Doc No: 2023-21730]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket Number USCG-2023-0466]
RIN 1625-AA00

Safety Zone; Wilmington River, Savannah, GA

AGENCY: Coast Guard, DHS.

ACTION: Temporary interim rule and request for comments.

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SUMMARY: The Coast Guard is revising a temporary safety zone
encompassing the Causton Bluff Bridge, on the Wilmington River,
Savannah, GA. This action is necessary to provide for the safety of
life on these navigable waters for the planned demolition and removal
of structural components of the original bridge, in preparation of the
construction of a new span. This rulemaking would prohibit persons and
vessels from being in the safety zone unless authorized by the Captain
of the Port Savannah or a designated representative.

DATES: This temporary interim rule is effective without actual notice
from October 3, 2023 through November 30, 2023. For the purposes of
enforcement, actual notice will be used from October 2, 2023, until
October 3, 2023.
    Comments and related material must reach the Coast Guard on or
before October 18, 2023.

ADDRESSES: You may submit comments identified by docket number USCG-
2023-0466 using the Federal Decision-Making Portal at https://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this rule,
call or email LTJG Anthony Harris, Office of Waterways Management,
Marine Safety Unit Savannah, U.S. Coast Guard; telephone<PHONE_NUMBER>
ext. 240, [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
ESA Endangered Species Act
FR Federal Register
GA DOT Georgia Department of Transportation
NPRM Notice of proposed rulemaking
TIR Temporary Interim Rule
Sec.  Section
U.S.C. United States Code

II. Background Information and Regulatory History

    On September 15, 2023, the Coast Guard published a temporary
interim rule (TIR) \1\ with requests for comment. The TIR established a
temporary safety zone encompassing the Causton Bluff Bridge, on the
Wilmington River, Savannah, GA. When the rule was published, the Coast
Guard immediately began receiving comments on the safety zone posted on
the docket and emails sent directly to the Coast Guard.\2\ In order to
address the concerns raised by the commenters, the Coast Guard made the
determination not to enforce the original TIR until an updated
enforcement schedule could be published through a new TIR. This new TIR
takes into consideration the 23 comments received thus far and revises
the existing safety zone to provide the public with a schedule that
equitably balances the needs of the Georgia Department of
Transportation (GA DOT) and the waterway users.
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    \1\ 88 FR 63527.
    \2\ The emailed comments have been posted to the docket folder.
These comments are accessible at: www.regulations.gov/docket/USCG-2023-0466/comments.
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    The Coast Guard is issuing this TIR without prior notice and
opportunity to comment pursuant to authority under section 4(a) of the
Administrative Procedure Act (APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule without prior notice and
opportunity to comment when the agency for good cause finds that those
procedures are ``impracticable, unnecessary, or contrary to the public
interest.'' Under 5 U.S.C. 553(b)(B), the Coast Guard finds that good
cause exists for not publishing a notice of proposed rulemaking (NPRM)
with respect to this TIR because doing so would be impracticable. This
revised safety zone must be established by October 2, 2023, in order to
protect vessels and waterway users from the potential hazards
associated with demolition operations on the Causton Bluff Bridge. We
lack sufficient time to provide a reasonable comment period and then to
consider those comments before issuing the rule.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this TIR effective less than 30 days after
publication in the Federal Register. Delaying the effective date of
this TIR would be contrary to the public's interest because we must
ensure the protection of vessels and waterway users during the
demolition operations.
    We are soliciting comments on this rulemaking. If we determine that
changes to this rulemaking action are necessary, the Coast Guard will
consider comments received in a subsequent TIR or temporary final rule.

III. Legal Authority and Need for Rule

    The Coast Guard is issuing this rule under authority in 46 U.S.C.
70034. The Captain of the Port Savannah (COTP) has determined that
potential hazards associated with the demolition operations of the
Causton Bluff Bridge. This rule is needed to protect personnel,
vessels, and the marine environment in the navigable waters within the
safety zone while the demolition project continues.

IV. Discussion of Comments, Changes and the Rule

    As noted above, we received 23 comment submissions on our TIR that
published in the Federal Register on September 15, 2023. The commenters
expressed concerns regarding the timing and duration of the demolition
operations, the restrictions on daylight hour transit for recreational
and commercial vessel traffic and related economic impacts, potential
dangers to recreational vessels in the designated anchorage area during
tropical storms and hurricanes, and the Coast Guard's notification
process. These concerns are discussed below.
    Several commenters expressed concerns about the timing of the
demolition project, particularly about scheduling the work during peak
``snowbird'' season, when seasonal recreational boaters transit from
northern states to warmer southern states, and the economic impact on
recreational vessel owners, along with other economic impacts to
shoreside docks and marinas.
    The project sponsor and the Coast Guard are unable to further delay
the project, as proposed by the commenters because of restrictions
related to the Federal Endangered Species Act (ESA) \3\ and related
Georgia State regulations. The project location coincides with the
habitat of the Atlantic sturgeon and shortnose sturgeon, which are
protected as an Endangered species by the Federal ESA. The National
Oceanic and Atmospheric Administration (NOAA)

and Georgia State regulations prevent in-water work, which would be
required for this project, from December 1 through April 30, which is
the combined spawning migration season for the Atlantic sturgeon and
the shortnose sturgeon. Therefore, the bridge project must occur before
that date.
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    \3\ 15 U.S.C. 1531 et seq.
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    Several commenters expressed concerns about restrictions on
daylight hour transit for recreational and commercial vessel traffic
through the safety zone, and where particularly concerned with
congestion and delays transiting the waterway, limits of designated
anchorage areas where vessels may safely wait for vessel traffic to
clear, and challenges of navigating the safety zone at night. The Coast
Guard is taking significant actions to minimize, to the extent
possible, the impact on commercial and recreational waterway use. The
restrictions on vessel traffic through the safety zone is intended to
facilitate the performance of the demolition project, mitigate the
dangers associated with the project, and to protect personnel, vessels,
and the marine environment in these navigable waters while the
demolition project continues. To address this concern, the Coast Guard
has modified the enforcement period to allow three hours a day for
vessels to transit during daylight.
    Two commenters inquired about the dangers tropical storms and
hurricanes would pose to the temporary safety zone. The COTP Savannah
has the authority to enact swift and detailed requirements during
tropical storms and hurricanes to safeguard the safety of all vessel
traffic and ensure the safe transit of the waterway.
    Several commenters expressed concerns about prior notice. In
section II. Background Information and Regulatory History, the Coast
Guard explains its legal basis for issuing this TIR without prior
notice and opportunity to comment pursuant to authority under section
4(a) of the APA (5 U.S.C. 553(b)). The Coast Guard has the authority to
publish TIRs to address situations like this. At all times we were
acting within the scope of authority and are making the changes here to
address this concern.
    Demolition operations will take place Monday through Sunday during
daylight hours. Periodically while the safety zone is implemented, all
vessel traffic will be permitted as reflected in Table 1 below.
Notwithstanding the below table, all commercial traffic, with width
clearances greater than 40 feet will be permitted passage outside the
prescribed windows listed in Table 1 below with prior coordination with
the demolition project contractor.

                                 Table 1
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                Open times                   Width clearance limitations
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10:00 a.m. to 10:30 a.m...................  Vessels 40 feet or less.
12:00 p.m. to 2:00 p.m....................  No limitations.
4:30 p.m. to 5:00 p.m.....................  Vessels 40 feet or less.
7:00 p.m. to 7:00 a.m.....................  No limitations.
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    The existing safety zone in 33 CFR 165.T07-0466 is being revised to
include Table 1 in the regulatory text. No further changes are being
made to the safety zone regulations.
    The duration of the revised safety zone is intended to protect
personnel, vessels, and the marine environment in these navigable
waters while the demolition project continues. No vessel or person will
be permitted to enter the safety zone without obtaining permission from
the COTP or a designated representative.

V. Regulatory Analyses

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

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. This rule has not been designated a ``significant
regulatory action,'' under section 3(f) of Executive Order 12866, as
amended by Executive Order 14094 (Modernizing Regulatory Review).
Accordingly, this rule has not been reviewed by the Office of
Management and Budget (OMB).
    This regulatory action determination is based on the size,
location, and duration of the safety zone. The duration of the zone is
intended to ensure the safety of vessels through the duration of the
vessel's inbound and outbound transit and offload. Moreover, the Coast
Guard will issue a Broadcast Notice to Mariners via VHF-FM marine
channel 16 about the zone, and the rule would allow vessels to seek
permission to enter the zone.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000. The Coast Guard certifies under 5 U.S.C. 605(b) that this rule
will not have a significant economic impact on a substantial number of
small entities.
    While some owners or operators of vessels intending to transit the
safety zone may be small entities, for the reasons stated in section
V.A above, this rule will not have a significant economic impact on any
vessel owner or operator.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this rule. If the rule would affect your
small business, organization, or governmental jurisdiction and you have
questions concerning its provisions or options for compliance, please
call or email the person listed in the FOR FURTHER INFORMATION CONTACT
section.
    Small businesses may send comments on the actions of Federal
employees who enforce, or otherwise determine compliance with, Federal
regulations to the Small Business and Agriculture Regulatory
Enforcement Ombudsman and the Regional Small Business Regulatory
Fairness Boards. The Ombudsman evaluates these actions annually and
rates each agency's responsiveness to small business. If you wish to
comment on actions by employees of the Coast Guard, call 1-888-REG-FAIR
(1-888-734-3247). The Coast Guard will not retaliate against small
entities that question or complain about this rule or any policy or
action of the Coast Guard.

C. Collection of Information

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

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on the States, on the
relationship between the National Government and the States, or on the
distribution of power and responsibilities among the various levels of
government. We have analyzed this rule under that Order and have
determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.

    Also, this rule does not have tribal implications under Executive
Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it does not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

E. Unfunded Mandates Reform Act

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

F. Environment

    We have analyzed this rule under Department of Homeland Security
Directive 023-01, Rev. 1, associated implementing instructions, and
Environmental Planning COMDTINST 5090.1 (series), which guide the Coast
Guard in complying with the National Environmental Policy Act of 1969
(42 U.S.C. 4321-4370f), and have determined that this action is one of
a category of actions that do not individually or cumulatively have a
significant effect on the human environment. This rule involves a
safety zone lasting several hours daily that would prohibit entry
within 300 yards of the Causton Bluff Bridge. The zone will prohibit
entry while in effect. It is categorically excluded from further review
under paragraph L60(a)of Appendix A, Table 1 of DHS Instruction Manual
023-01-001-01, Rev. 1. A Record of Environmental Consideration
supporting this determination is available in the docket. For
instructions on locating the docket, see the ADDRESSES section of this
preamble. We seek any comments or information that may lead to the
discovery of a significant environmental impact from this rule.

G. Protest Activities

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

VI. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    Submitting comments. We encourage you to submit comments through
the Federal Decision-Making Portal at https://www.regulations.gov. To
do so, go to https://www.regulations.gov, type USCG-2023-0466 in the
search box and click ``Search.'' Next, look for this document in the
Search Results column, and click on it. Then click on the Comment
option. If you cannot submit your material by using https://www.regulations.gov, call or email the person in the FOR FURTHER
INFORMATION CONTACT section of this rule for alternate instructions.
    Viewing material in docket. To view documents mentioned in this
rule as being available in the docket, find the docket as described in
the previous paragraph, and then select ``Supporting & Related
Material'' in the Document Type column. Public comments will also be
placed in our online docket and can be viewed by following instructions
on the https://www.regulations.gov. Frequently Asked Questions web
page. Also, if you click on the Dockets tab and then the rule, you
should see a ``Subscribe'' option for email alerts. The option will
notify you when comments are posted, or a final rule is published.
    We review all comments received, but we will only post comments
that address the topic of the rule. We may choose not to post off-
topic, inappropriate, or duplicate comments that we receive.
    Personal information. We accept anonymous comments. Comments we
post to https://www.regulations.gov will include any personal
information you have provided. For more about privacy and submissions
to the docket in response to this document, see DHS's eRulemaking
System of Records notice (85 FR 14226, March 11, 2020).

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority: 46 U.S.C. 70034, 70051; 33 CFR 1.05-1, 6.04-1, 6.04-
6, and 160.5; Department of Homeland Security Delegation No.
00170.1, Revision No. 01.3.

0
2. Revise Sec.  165.T07-0466 to read as follows:

Sec.  165.T07-0466  Safety Zone; Wilmington River, Savannah, GA.

    (a) Location. All navigable waters, from surface to bottom, of the
Wilmington River within a 300-yard radius of position: 32[deg]3.73' N,
81[deg]1.78' W in the vicinity of the Causton Bluff Bridge, Savannah,
GA.
    (b) Definitions. As used in this section, designated representative
means a Coast Guard Patrol Commander, including a Coast Guard coxswain,
petty officer, or other officer operating a Coast Guard vessel and a
Federal, State, and local officer designated by or assisting the
Captain of the Port Savannah (COTP) in the enforcement of the safety
zone.
    (c) Regulations. (1) Under the general safety zone regulations in
subpart C of this part, you may not enter the safety zone described in
paragraph (a) of this section unless authorized by the COTP or the
COTP's designated representative.
    (2) To seek permission to enter, contact the COTP or the COTP's
representative by calling<PHONE_NUMBER>. Those in the safety zone must
comply with all lawful orders or directions given to them by the COTP
or the COTP's designated representative.
    (d) Enforcement periods. The safety zone in paragraph (a) of this
section is in effect from 12:01 a.m. on October 2, 2023, through 11:59
p.m. on November 30, 2023. This section will be subject to enforcement
periodically during daylight hours as needed by the project manager to
safely remove all remaining bridge structural components. The
approximate enforcement schedule is reflected in Table 1 to Sec.
165.T07-0466. Mariners will be informed of enforced zone and
enforcement periods by Broadcast Notice to Mariners and the presence of
Myrick Marine's safety boat on scene during working hours.

                     Table 1 to Sec.   165.T07-0466
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                Open times                   Width clearance limitations
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10:00 a.m. to 10:30 a.m...................  Vessels 40 feet or less.
12:00 p.m. to 2:00 p.m....................  No limitations.
4:30 p.m. to 5:00 p.m.....................  Vessels 40 feet or less.
7:00 p.m. to 7:00 a.m.....................  No limitations.
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    Dated: September 27, 2023.
Nathaniel L. Robinson,
Commander, U.S. Coast Guard, Captain of the Port, Savannah, GA.
[FR Doc. 2023-21730 Filed 10-2-23; 8:45 am]
BILLING CODE 9110-04-P


_____________________________________________________________________________________________ Science Applications International Corporation. 11251 Roger Bacon Drive, Reston, VA 20190 1 MEMORANDUM To: Paul Shriner, Shari Goodwin, Regno Arulgnanendran From: John Sunda Date: September 12, 2005 Subject: Summary of Changes in Compliance Costs between 316( b) Phase III Proposed Rule and NODA This memo presents the underlying reasons for the changes in the compliance costs between the Phase III proposed rule and the Phase III NODA. As described in the NODA and in the record supporting the NODA, several changes were made in the calculation of compliance costs for Phase III facilities.

The focus of this discussion is on the differences between the costs at proposal and the costs at NODA for the > 50 MGD option. Generally, the same approach was used to determine the costs for both the Proposal and NODA, especially with regard to the intake flows used in calculating the costs. For the proposed rule, costs were based on the design intake flow ( DIF) and in the NODA, costs were based on the " corrected" DIF that reflected updated information about facility intake flows.

Variations in costs between the different options ( i. e., > 50 MGD, > 100 MGD and > 200 MGD) generally reflected the fact that the > 100 MGD and > 200 MGD options involved a fewer number of facilities than the > 50 MGD option and thus overall changes as a percentage of the total cost are more greatly influenced by the inclusion or exclusion of individual facilities, with a corresponding increase or a decrease in the various cost components.

For the Phase III NODA, a sensitivity analysis was also done using the Maximum Reported Intake Flow ( MRIF) and the Average Intake Flow ( AIF) as alternate intake flows for developing facility costs. A description of the reasons for difference in costs between the proposed rule and NODA when the alternate intake flows, i. e., DIF, AIF and MRIF are used as input variables in the cost tool is included below.

CAPITAL COST Proposed Rule vs NODA For the > 50 MGD option ( using the DIF and " corrected" DIF for calculating the costs at proposal and NODA, respectively), the total capital costs for the NODA decreased approximately ten percent from the costs at proposal. Because there were few changes to the technology modules themselves, the changes in capital costs are primarily due to changes to the facility specific input variables in the cost tool. These changes in cost tool input variables resulted in changes to the selected compliance technology modules for nearly a third of the facilities. The cost tool input variables that likely had the greatest impact on costs were changes made to the intake description, impingement technology in place, qualified impingement, entrainment technology in place, and qualified entrainment.

As a result of these changes, 29 of the 92 intake systems costed for the > 50 MGD option had changes in the compliance technology. Table 1 presents the number of facilities where the assigned technology module at proposal were changed at NODA. _____________________________________________________________________________________________ Science Applications International Corporation. 11251 Roger Bacon Drive, Reston, VA 20190 2 Table 1. Changes in Technology Module Allocation Between Proposal and NODA Number of Facilities Technology Module Assigned in Proposed Rulea Technology Module Assigned in NODAa 8 9 1 2 2 2a 2 9 8 1 12 2a 1 9 2a 1 9 0 1 4 0 1 2a 0 1 1 0 1 3 9 1 0 9 1 0 2a 1 0 2 2 0 1 1 4 3 1 2a 1 1 4 9 1 8 1 1 3 11 a. Descriptions of the technology modules are presented on Exhibit 5 5, page 5 6 of the Technical Development Document for the Proposed Section 316( b) Phase III Rule and Attachment 1 of this memo In addition to the above changes in assignment of technology modules, the costs for six facilities were calculated at an intake specific level instead of being calculated at a facility specific level. This is because each of these six facilities had intakes with distinctively different attributes in either the type of water body from which they withdraw cooling water, the type of intake screen used, and/ or the location and depth of intake with respect to the shoreline or the intake screen velocity. This separation of intakes enabled distinguishing intakes with qualified impingement or entrainment technologies from those intakes that have none of the required technologies. These changes in attributes for a portion of the intakes often resulted in a change to the technology module. The resulting changes in capital costs from these changes are mixed because in some cases a facility costed as having a single intake may have been determined as qualified for existence of impingement or entrainment technologies at proposal and determined as having none of the impingement or entrainment technologies at NODA, due to the separation of the intakes. _____________________________________________________________________________________________ Science Applications International Corporation. 11251 Roger Bacon Drive, Reston, VA 20190 3 Capital costs for a few facilities increased slightly when a fish return was assigned as the technology module for the facility. For facilities with intake canals, the cost for any additional added length of fish return sluice was included as an input variable to the technology module, thus increasing the capital costs for these facilities.

Another change in the technology modules was the use of a different set of equations for technology module 3 ( Addition of a new, larger intake with fine mesh and fish handling and return system in front of an existing intake system) that applied to facilities with a total compliance screen width of > 10 ft. This change resulted in a substantial reduction in the capital costs for one facility.

In a few cases, the DIF flow values used at proposal were revised because portions of the reported intake flow was not used for cooling purposes or was already in compliance.

For the > 100 MGD and > 200 MGD options, the changes in compliance costs comprised of a subset of the changes for the > 50 MGD option with different combinations. One facility in the > 200 MGD option included the module 9 to module 1 change. One facility in each of these options changed from not requiring technologies ( module 0) to requiring technologies and one facility in the > 100 MGD option and two facilities in the > 200 MGD option changed from requiring technologies to requiring none ( module 0). As such, the changes in capital costs increased for the > 100 MGD option but decreased slightly for the > 200 MGD option, with the overall change being subject to the different combinations of facilities and compliance technology changes.

DIF vs MRIF or AIF The use of MRIF or AIF as an alternative intake flow to the DIF resulted in a general reduction in the capital costs, but only for those facilities where the technology module ( all technology modules except 1, 2, 2a, and 11) 1 did not involve using the existing traveling screens. Because technology modules 1, 2, 2a, and 11 involve modifying or replacing exiting traveling screens, the costs for these modules are based on an estimate of the total screen width of the existing intake. As the existing intake cannot be easily re sized for different intake flows, the costs for these technology modules are based on the DIF and not based on MRIF or AIF. For facilities with technology modules other than 1, 2, 2a, and 11, the capital costs at NODA are significantly lower than costs estimated at proposal when MRIF or AIF are used as the intake flow input variable instead of DIF.

PILOT STUDY COST Proposal vs NODA For the > 50 MGD option ( using DIF and " corrected" DIF), the total pilot study costs for the NODA also decreased approximately ten percent from the proposal costs. The pilot study costs are calculated as ten percent of the capital costs, with a minimum pilot study cost of $ 150,000. Hence pilot study costs vary in a similar manner as the capital costs. Also, changes in the selected compliance technology module will affect whether pilot study costs are required for a particular facility. Thus, changes in pilot study costs mirror changes in capital costs for the > 50 MGD option, but to a lesser extent for the > 100 MGD and > 200 MGD option.

DIF vs MRIF or AIF When MRIF or AIF were used as an alternate intake flow instead of DIF, the reduction in the pilot study costs are larger in magnitude than the changes in capital costs. One reason for this reduction in pilot study costs is that when the estimated capital costs are below $ 500,000, the pilot study costs default to zero. This is because of the assumption that pilot studies are warranted only where the capital costs are high and the risk of failure of investment is also high. Moreover, as the pilot study costs are derived as a percentage of the capital costs, a reduction in capital costs, associated with the use of a lower intake flow will in turn cause more facilities not requiring pilot studies.

1 Descriptions of the technology modules are presented on Exhibit 5 5, page 5 6 of the Technical Development Document for the Proposed Section 316( b) Phase III Rule and Attachment 1 of this memo _____________________________________________________________________________________________ Science Applications International Corporation. 11251 Roger Bacon Drive, Reston, VA 20190 4 NET O& M Proposal vs NODA For the > 50 MGD option ( using DIF and " corrected" DIF), the net O& M costs for the NODA decreased approximately 38 percent from the net O& M costs at proposal. This decrease in net O& M costs is due to several factors. The most significant reason for this cost decrease was the use of AIF instead of the DIF to calculate the variable portion of the O& M costs. As noted in the proposed rule, DIF was used to calculate both the variable and fixed portions of the net O& M costs.

The second factor that contributed to the decrease in O& M costs at NODA was the increase in baseline O& M costs due to the addition of baseline costs for passive intake technologies in place together with changes to the input variables for technologies in place. This resulted in an increase in the number of facilities identified as having traveling screens in place. Since the baseline O& M costs are deducted from the compliance technology O& M costs, higher baseline O& M costs will yield decreases in the net O& M costs.

DIF vs MRIF or AIF The slightly greater reduction in O& M costs when the MRIF or AIF are used is due to the fact that O& M costs for the technology modules that are not based on retrofitting the existing traveling screens ( all technology modules except 1, 2, 2a, and 11) are based on the selected intake flow, and thus are lower when smaller intake flows ( i. e., MRIF or AIF instead of DIF) are used. _____________________________________________________________________________________________ Science Applications International Corporation. 11251 Roger Bacon Drive, Reston, VA 20190 5 Attachment 1. Technology Module Codes and Technology Module Descriptions Technology Module Codes Technology Module Description 1 Addition of fish handling and return system to an existing traveling screen system 2 Addition of fish handling and return system and fine mesh screens to an existing traveling screen system 2a Addition of fine mesh screens to an existing traveling screen system which has a fish return 3 Addition of a new, larger intake with fine mesh and fish handling and return system in front of an existing intake system 4 Addition of passive fine mesh screen system ( cylindrical wedgewire) near shoreline with mesh width of 1.75 mm 5 Addition of a fish net barrier system 6 Addition of an aquatic filter barrier system 7 Relocation of an existing intake to a submerged offshore location with passive fine mesh screen inlet with mesh width of 1.75 mm 8 Addition of a velocity cap inlet to an existing offshore intake 9 Addition of passive fine mesh screen to an existing offshore intake with mesh width of 1.75 mm 10 [ Module 10 not used] 11 Addition of dual entry, single exit traveling screens ( with fine mesh) to a shoreline intake system 12 Addition of passive fine mesh screen system ( cylindrical wedgewire) near shoreline with mesh width of 0.76 mm 13 Addition of passive fine mesh screen to an existing offshore intake with mesh width of 0.76 mm 14 Relocation of an existing intake to a submerged offshore location with passive fine mesh screen inlet with mesh width of 0.76 mm


[Federal Register Volume 77, Number 51 (Thursday, March 15, 2012)]
[Proposed Rules]
[Pages 15335-15336]
[FR Doc No: 2012-6049]

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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Parts 141 and 142

[FRL-9645-8 ]

Notice of Public Meetings: Arsenic Small Systems Compliance and
Alternative Affordability Criteria Working Group

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Public Meetings.

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SUMMARY: EPA is holding three meetings of the Arsenic Small Systems
Working Group to discuss barriers to the use of arsenic treatment
technologies and alternative affordability criteria. The first and
second of these meetings will be held via Webcast. The third meeting
will be held in Arlington, Virginia. Interested members of the public
may participate in the two Webcasts via the Internet and may attend the
third meeting in person.

DATES: The Working Group Webcast meetings will be held on March 20,
2012 (11:30 a.m. to 5:30 p.m. Eastern Time (ET)), and March 22, 2012 (1
p.m. to 5 p.m. ET). The third meeting will be held on April 4, 2012, at
9 a.m. ET and conclude on April 5, 2012, at 4 p.m. ET.

ADDRESSES: The first two meetings will be held via the Internet using a
Webcast and teleconference. Persons wishing to participate in the
Webcasts must register in advance as described in the SUPPLEMENTARY
INFORMATION section. Registrants will receive an Internet access link
and dial in number upon registration for the Webcast. The third meeting
will be held at Potomac Yards South, first floor conference room
located at 2777 South Crystal Drive Arlington, VA 22202. A government
issued photo ID is required to obtain access to the building.

FOR FURTHER INFORMATION CONTACT: For questions about these specific
meetings, contact Russ Perkinson, Office of Ground Water and Drinking
Water, U.S. Environmental Protection Agency; telephone<PHONE_NUMBER>
or by email to perkinson.russ@epa.govmailto:.

SUPPLEMENTARY INFORMATION: Congressional language contained in the
Conference Report (H.R. 2055) accompanying the Consolidated
Appropriations Act of 2012 directs the Environmental Protection Agency
to convene an Arsenic Small Systems Working Group composed of
representatives from States, small publicly owned water systems, local
public health officials, drinking water consumers and treatment
manufacturers to provide individual input and recommendations on
barriers to the use of point-of-use and point-of-entry treatment units,
package plant, and modular units, as well as alternative affordability
criteria that give extra weight to small, rural, and lower income
communities. Based upon input from the working group, the EPA will
submit to Congress a report on actions to make alternative compliance
methods more accessible to water systems and a report on alternative
affordability criteria.
    To participate in the Webcasts, you must register in advance at the
following Web address: https://www3.gotomeeting.com/register/127876830
for the March 20 Webcast on barriers to the use of arsenic treatment
technologies; and https://www3.gotomeeting.com/register/796765574 for
the March 22 Webcast on alternative affordability criteria. The number
of connections available for the Webcast is limited and will be
available on a first come, first served basis. To participate in the
April 4 through 5 meeting, you must register in advance no later than 5
p.m. ET on April 2, 2012, by email to<EMAIL_ADDRESS>or phone
at<PHONE_NUMBER>. Seating for the public is limited and will be
available on a first come, first served basis for those persons
registered. During the Webcasts and meetings, a public comment period
will be held for those wishing to speak who have registered in advance.
Individual comments should be limited to no more than three minutes and
we ask that only one person present the statement on behalf of a group
or organization. Individuals wishing to speak during the public comment
period or individuals without Internet access seeking alternative means
to participate in the Webcasts must contact Russ Perkinson at (202)
564-4901 or by email to<EMAIL_ADDRESS>no later than 5 p.m. two
business days prior to the meeting. Please specify the date of the
meeting(s) to which the request applies.

Special Accommodations

    To request special accommodations for individuals with
disabilities, please contact Russ Perkinson at<PHONE_NUMBER> or by
email to<EMAIL_ADDRESS>Please allow at least five business
days prior to the meeting to allow time to process your request.

    Dated: March 8, 2012.
Cynthia C. Dougherty,
Director, Office of Ground Water and Drinking Water.
[FR Doc. 2012-6049 Filed 3-14-12; 8:45 am]
BILLING CODE 6560-50-P


Hydrogen Cyanide/ PC Code 045801 Subchronic Oral Study ( Humans) ( 1982)/ Page 1 of 5 EPA Reviewer: William Dykstra, Ph. D Signature: Reregistration Branch 4, Health Effects Division ( 7509C) Date EPA Secondary Reviewer: Pramod Terse, PhD, DVM Signature: Reregistration Branch 4, Health Effects Division ( 7509C) Date Template version 11/ 01Template version 11/ 01 TXR#: none DATA EVALUATION RECORD STUDY TYPE: Subchronic Oral Study ( Humans)

PC CODE: 045801 TEST MATERIAL ( PURITY): D mandelonitrile   D glucosido 6 D glucoside; Amygdalin SYNONYMS: Laetrile CITATION: Moertel, CG et al ( 1982). A Clinical Trial of Amygdalin ( Laetrile) in the Treatment of Human Cancer. New England Journal of Medicine, Vol. 306, No. 4: 201 206, MRID # 46769602, published.

Moertel, CG et al ( 1981) A Pharmacologic and Toxicological Study of Amygdalin. JAMA, Vol. 245, No. 6: 591 594, MRID # 46769601, published.

SPONSOR: National Cancer Institute, USA.

EXECUTIVE SUMMARY: In a clinical trial of Amygdalin, one hundred seventy eight cancer patients were treated with amygdalin ( Laetrile) plus a " metabolic therapy" consisting of diet, enzymes and vitamins. Amygdalin was administered at an intravenous dose of 4.5 g/ m2 of body surface area/ day in the Standard Dose or 7 g/ m2 of body surface area/ day at the High Dose for 21 days. Following intravenous treatment, amygdalin was administered orally at 0.5 g three times daily at the Standard Dose Regimen or 0.5 g four times daily at the High Dose Regimen until the patient had definite evidence of progressive malignant disease or until severe clinical deterioration occurred. Amygdalin releases HCN upon enzymatic action of $ glucosidase in GI tract causing high blood cyanide level and producing clinical toxicity. Clinical signs and symptoms consisting of nausea ( 30 31%), vomiting ( 17 25%), headaches ( 7 8%), dizziness ( 7 10%), mental obtundation ( 4 5%) and dermatitis ( 2%) were observed on occasion following a single 0.5 g oral dose of amygdalin. These typical symptoms of cyanide toxicity associated with elevated blood cyanide levels were also seen when two 0.5 g oral doses were taken at the same time, or shortly apart, to compensate for a missed dose or when consumed raw almonds ( a rich source of $ glucosidase) following oral therapy. Therefore, the single dose of 0.5 g of amygdalin was determined to be a minimally toxic dose, whereas the double dose was generally regarded as frankly toxic. No substantive benefit of Amygdalin therapy was observed in terms of cure, improvement, or stabilization of cancer, or extension of life span. Thus, amygdalin ( laetrile) is a toxic drug with no therapeutic effect on cancer. Hydrogen Cyanide/ PC Code 045801 Subchronic Oral Study ( Humans) ( 1982)/ Page 2 of 5 The study is acceptable/ non guideline .

Materials and Methods:

1. Patient Selection: Histologically proved one hundred seventy eight ( 178) cancer patients for which no standard treatment was known to be curative or to extend life expectancy were selected. All patients had no surgery, radiation therapy, or chemotherapy for at least one month prior to being selected for admission to the trials. Disabled and bedridden patient were excluded from study.

Table 1. Characteristics of Eligible Patients Characteristic Standard Dose Regimen High Dose Regimen Total Patients No. of patients Sex Male Female 92 72 8 6 100 78 Age ( yr) Median Range 57 18 84 60 39 73 57 18 84 Primary Tumor Colorectal* Lung+ Breast* Melanoma Sarcoma Pancreas* Stomach* Kidney* Lymphoma Ovary* Other ( 1 or 2 each) 44 30 21 15 10 8 7 6 5 4 14 14           58 30 21 15 10 8 7 6 5 4 14 Prior radiation therapy Yes no 72 92 0 14 72 106 Prior chemotherapy Yes no 109 55 9 5 118 60 ( 34) Performance status** 0 1 2 3 116 48 11 3 127 51 Hydrogen Cyanide/ PC Code 045801 Subchronic Oral Study ( Humans) ( 1982)/ Page 3 of 5 Institution U. Arizona UCLA Mayo Clinic NY Memorial 19 40 82 23   14  19 40 96 23 * Adenocarcinoma + Non small cell carcinoma ** Eastern Cooperative Oncology Group Score: 0, fully active to 4, totally disabled 2. Treatment Methods: The amygdalin was supplied by the Pharmaceutical Resources Branch of the NCI in vials containing 3 g of lyophilized RS amygdalin ( racemic mixture) and for oral use in tablets containing 0.5 g of R amygdalin. The routes, dosage, and schedule of amygdalin treatment were chosen to be consistent with current Laetrile practice. " All patients were fully informed about the experimental and un orthodox nature of the treatment program as well as any possible alternative treatment available to them. A signed form giving informed consent, approved by the Human Subjects Committee at each of the four participating centers, was obtained from each patient."

For the standard regimen, the intravenous doses were administered in 21 daily injections at a daily dose of 4.5 g per square meter of body surface area. The intravenous dose was given either on consecutive days ( 121 eligible patients) or during weekdays only ( 57 patients). After completion of the intravenous phase of the study, oral maintenance therapy was initiated at a dose of 0.5 g given three times a day.

In the high dose regimen, the intravenous dose the intravenous doses were administered in 21 daily injections at a daily dose of 7.0 g per square meter of body surface area. After completion of the intravenous phase of the study, oral maintenance therapy was initiated at a dose of 0.5 g given four times a day. " Metabolic therapy" of large doses of vitamins, minerals, and pancreatic enzymes were also administered to patients in the standard and high dose regimens.

Before therapy, a pertinent medical history was obtained from patient and a complete physical examination was given including a chest x ray film, blood counts, and blood chemistry determinations. The evaluation was repeated after the intravenous course, after the first two weeks of oral treatment, and every five weeks thereafter. In addition, whole blood cyanide levels were determined two hours after the first morning dose of oral amygdalin ( a time to peak cyanide levels) at the completion of intravenous treatment, 48 hours after the initiation of oral treatment, and at every subsequent reevaluation. If the morning blood cyanide level was between 2 to 3 Fg/ ml at 48 hours after the initiation of oral therapy, daily blood levels of cyanide were measured until they had stabilized without clinical signs of toxicity. If the blood cyanide level was found to be 3 Fg/ ml or greater at any time, therapy was permanently discontinued.

Amygdalin treatment was continued until the patient had definite evidence of progressive malignant disease or until severe clinical deterioration. Hydrogen Cyanide/ PC Code 045801 Subchronic Oral Study ( Humans) ( 1982)/ Page 4 of 5 Results:

Mild and transient adverse clinical signs were noticed during intravenous and oral amygdalin treatment ( table 2). Although blood cyanide levels after intravenous administration were " negligible or not detectable", it is plausible that some breakdown of amygdalin with cyanide release might have occurred. In the previous study by Moertel et al., 1981 showed that amygdalin given intravenously ( 4.5 g/ sq m/ day) was excreted unchanged in the urine and produced no clinical or laboratory evidence of toxicity. In contrast, a few patients receiving oral amygdalin had a syndrome of headache, dizziness, mental obtundation, nausea and vomiting. These symptoms subsided promptly when the oral amygdalin treatment was discontinued. These clinical signs were also seen in the previous oral study by Moertel et al., 1981.

Table 2. Toxicity of Amygdalin Therapy Toxic Reaction Route Intravenous Oral % of 178 patients % of 132 patients Nausea 31 30 Vomiting 25 17 Headache 7 8 Dizziness 7 10 Mental obtundation 4 5 Dermatitis 2 2 Discussion:

Hydrogen cyanide ( HCN) is extremely acutely toxic by the oral route with a fatal dose in humans estimated to be 50 90 mg total or 1 mg/ kg BW ( FDA, 1956). The lowest fatal dose reported in humans was estimated as 0.56 mg/ kg BW cyanide ( form not specified) ( Gettler and Baine, 1938). However, these data were obtained from the case history; furthermore, analytical measurements of the time lack the precision of current technology. Similarly, both sodium and potassium cyanide have lethal doses ( calculated as HCN) given as 200 mg total, representing 81 and 110 mg HCN, respectively, which also fall within the range for HCN given above ( FDA, 1956).

In the Moertel et al studies ( 1981, 1982), amygdalin was administered at an intravenous dose of 4.5 g/ m2 of body surface area/ day for 21 days in the Standard Dose or 7 g/ m2 of body surface area/ day for 21 days at the High Dose. Following intravenous treatment, amygdalin was administered orally at 0.5 g, three times daily at the Standard Dose Regimen or 0.5 g, four times daily at the High Dose Regimen. Clinical signs and symptoms consisting of nausea, vomiting, headaches, dizziness, metal obtundation and on a few occasions, dermatitis occurred in some patients on occasion following a single 0.5 g oral dose of amygdalin or when two 0.5 g doses were administered at the same time, or shortly apart, to compensate for a missed dose and in one Hydrogen Cyanide/ PC Code 045801 Subchronic Oral Study ( Humans) ( 1982)/ Page 5 of 5 patient who consumed raw almonds following oral therapy. Blood levels of cyanide rose when the single 0.5 g dose was doubled to two 0.5 g doses at an administration. These increased blood levels were associated with an increase in the incidence and severity of some of the toxic signs and symptoms due to the release of HCN from amygdalin by the enzymatic action of   glucosidase, an intestinal enzyme. Therefore, the single dose of 0.5 g of amygdalin was determined to be a minimally toxic dose, whereas the double dose was generally regarded as toxic. In the Standard Dose study, a single dose 0.5 g of amygdalin results in 29.4 mg of HCN ( 500 mg/ 17.1 mw of laetrile/ hydrogen cyanide = 29.4 mg of HCN). When the HCN content is divided by the approximate BW of 70 kg, the result is 0.4 mg/ kg BW/ day.

This single oral dose level ( 0.4 mg/ kg BW) for HCN has been identified as a LOAEL by Moertel et al ( 1982) in comparison to the human NOAEL of 0.2 mg/ kg BW for thiocyanate determinations in human saliva ( FDA, 1956) and the LOAEL for cyanide mortality of 0.56  1.0 mg/ kg BW.

References:

Gettler AO, Baine JO ( 1938) The toxicology of cyanide. Am J Med Sci 195: 182 198.

Food and Drug Administration ( FDA, 1956) Association of Food and Drug Officials: Quarterly Report to the Editor on Topics of Current Interest: Hydrogen Cyanide and Amygdalin. AJ Lehman, Ph. D., M. D., Editor


[Federal Register Volume 79, Number 177 (Friday, September 12, 2014)]
[Notices]
[Page 54704]
[FR Doc No: 2014-21802]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. AD14-14-000]

Price Formation in Energy and Ancillary Services Markets Operated
by Regional Transmission Organizations and Independent System
Operators; Notice of Workshop

    As announced in the Notice issued on June 19, 2014, the Federal
Energy Regulatory Commission (Commission) directed its staff to convene
workshops as necessary to commence a discussion with industry on
existing market rules and operational practices affecting price
formation issues in energy and ancillary services markets operated by
Regional Transmission Organizations (RTOs) and Independent System
Operators (ISOs). The June 19 Notice listed four areas of interest:
uplift payments, offer price mitigation and offer price caps, scarcity
and shortage pricing, and operator actions that affect prices. The
second workshop will address technical, operational, and market issues
related to offer price mitigation and offer price caps, and scarcity
and shortage pricing in energy and ancillary services markets operated
by RTOs and ISOs, and will be held on Tuesday, October 28, 2014 from
8:45 a.m. to 5:00 p.m. in the Commission Meeting Room at the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC,
20426. Commission members may participate in the workshop.
    The workshop will be open for the public to attend. Advance
registration is not required, but is encouraged. Attendees may register
at the following Web page: https://www.ferc.gov/whats-new/registration/10-28-14-form.asp.
    Those wishing to participate in the program for this event should
nominate themselves through the on-line registration form no later than
September 23, 2014 at the following Web page: https://www.ferc.gov/whats-new/registration/10-28-14-speaker-form.asp. At this Web page,
please provide an abstract (1,500 character limit) of the issue(s) you
propose to address. Due to time constraints, we may not be able to
accommodate all those interested in speaking.
    Further details and a formal agenda will be issued prior to the
workshop.
    Information on this event will be posted on the Calendar of Events
on the Commission's Web site, www.ferc.gov, prior to the event. The
workshop will also be Webcast and transcribed. Anyone with Internet
access who desires to listen to this event can do so by navigating to
the Calendar of Events at www.ferc.gov and locating this event in the
Calendar. The event will contain a link to the webcast. The Capitol
Connection provides technical support for Webcasts and offers the
option of listening to the meeting via phone-bridge for a fee. If you
have any questions, visit www.CapitolConnection.org or call 703-993-
3100.
    Commission workshops are accessible under section 508 of the
Rehabilitation Act of 1973. For accessibility accommodations, please
send an email to<EMAIL_ADDRESS>or call toll free 1-866-208-
3372 (voice) or<PHONE_NUMBER> (TTY), or send a FAX to<PHONE_NUMBER> with
the required accommodations.
    For further information on this workshop, please contact:

Logistical Information

Sarah McKinley, Office of External Affairs, Federal Energy Regulatory
Commission, 888 First Street NE. Washington, DC 20426,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
Scarcity/shortage pricing

Bob Hellrich-Dawson, Office of Energy Policy and Innovation, Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426 ,<PHONE_NUMBER><EMAIL_ADDRESS>
Offer Price Mitigation and Offer Price Caps

Emma Nicholson, Office of Energy Policy and Innovation, Federal Energy
Regulatory Commission, 888 First Street NE., Washington, DC 20426,
(202) 502-8846<EMAIL_ADDRESS>
     Dated: September 5, 2014.
Nathaniel J. Davis, Sr.,
Deputy Secretary.
[FR Doc. 2014-21802 Filed 9-11-14; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register: December 24, 2008 (Volume 73, Number 248)]
[Notices]
[Page 79133-79134]
[DOCID:fr24de08-91]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0045] (formerly Docket No. 2004N-0408)

Regulatory Site Visit Training Program

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration's (FDA's) Center for
Biologics Evaluation and Research (CBER) is reannouncing the invitation
for participation in its Regulatory Site Visit Training Program (RSVP).
This training program is intended to give CBER regulatory review,
compliance, and other relevant staff an opportunity to visit biologics
facilities. These visits are intended to allow CBER staff to directly
observe routine manufacturing practices and to give CBER staff a better
understanding of the biologics industry, including its challenges and
operations. The purpose of this notice is to invite biologics
facilities to contact CBER for more information if they are interested
in participating in this program.

DATES: Submit a written or electronic request for participation in this
program by January 23, 2009. The request should include a description
of your facility relative to products regulated by CBER. Please specify
the physical address of the site(s) you are offering.

ADDRESSES: If your biologics facility is interested in offering a site
visit or learning more about this training opportunity for CBER staff,
or if your biologics facility responded to a previous RSVP notice
announced in the Federal Register, you should submit a request to
participate in the program to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852. Submit electronic requests to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Lonnie Warren Myers, Division of
Manufacturers Assistance and Training, Center for Biologics Evaluation
and Research (HFM-49), Food and Drug Administration, 1401 Rockville
Pike, suite 200N, Rockville, MD 20852-1448,<PHONE_NUMBER>, FAX: 301-827-
3079, email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    CBER regulates certain biological products including blood and
blood products, vaccines, and cellular, tissue, and gene therapies.
CBER is committed to advancing the public health through innovative
activities that help ensure the safety, effectiveness and timely
delivery of biological products to patients. To support this primary
goal, CBER has initiated various training and development programs to
promote high performance of its compliance staff, regulatory review
staff, and other relevant staff. CBER seeks to continuously enhance and
update review efficiency and quality, and the quality of its regulatory
efforts and interactions, by providing CBER staff with a better
understanding of the biologics industry and its operations. Further,
CBER seeks to improve: (1) Its understanding of current industry
practices, and regulatory impacts and needs; and (2) communication
between CBER staff and industry. CBER initiated its RSVP in 2005, and
through these annual notices, is requesting those firms that have
previously applied and are still interested in participating, to
reaffirm their interest, as well as

encouraging new interested parties to apply.

II. RSVP

A. Regulatory Site Visits

    In this program, over a period of time to be agreed upon with the
facility, small groups of CBER staff may observe operations of
biologics establishments, including for example, blood and tissue
establishments. The visits may include packaging facilities, quality
control and pathology/toxicology laboratories, and regulatory affairs
operations. These visits, or any part of the program, are not intended
as a mechanism to inspect, assess, judge, or perform a regulatory
function, but are meant to improve mutual understanding and to provide
an avenue for open dialogue between the biologics industry and CBER.

B. Site Selection

    All travel expenses associated with the site visits will be the
responsibility of CBER; therefore, selection of potential facilities
will be based on the coordination of CBER's priorities for staff
training as well as the limited available resources for this program. A
key element of site selection is a successful compliance record with
CBER or another agency for which we have a memorandum of understanding.
Facilities should also be advised that if a site visit involves a
separate physical location of another firm under contract to the
applicant, then this contract site must be in agreement to participate
in the program, as well as have a satisfactory compliance history.

III. Requests for Participation

    Requests are to be identified with the docket number found in the
brackets in the heading of this document. Received requests are
available for public examination in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: December 19, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30659 Filed 12-23-08; 8:45 am]

BILLING CODE 4160-01-S