[Federal Register Volume 76, Number 118 (Monday, June 20, 2011)]
[Proposed Rules]
[Pages 35802-35805]
[FR Doc No: 2011-15165]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 100

[Docket No. USCG-2011-0266]
RIN 1625-AA08

Special Local Regulations for Marine Events; Patuxent River,
Solomons, MD

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to establish special local
regulations during the ``Chesapeake Challenge'' power boat races, a
marine event to be held on the waters of the Patuxent River, near
Solomons, MD on September 24 and 25, 2011. These special local
regulations are necessary to provide for the safety of life on
navigable waters during the event. This action is intended to
temporarily restrict vessel traffic in a portion of the Patuxent River
during the event.

DATES: Comments and related material must be received by the Coast
Guard on or before July 20, 2011. Requests for public meetings must be
received by the Coast Guard on or before the end of the comment period.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0266 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or e-mail Mr. Ronald Houck, U.S. Coast Guard Sector
Baltimore, MD; telephone<PHONE_NUMBER>, e-mail<EMAIL_ADDRESS>
If you have questions on viewing or submitting material to the docket,
call Renee V. Wright, Program Manager, Docket Operations, telephone
202-366-9826.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-0266), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (via http://www.regulations.gov) or by fax, mail, or hand
delivery, but please use only one of these means. If you submit a
comment online via http://www.regulations.gov, it will be considered
received by the Coast Guard when you successfully transmit the comment.
If you fax, hand deliver, or mail your comment, it will be considered
as having been received by the Coast Guard when it is received at the
Docket Management Facility. We recommend that you include your name and
a mailing address, an e-mail address, or a telephone number in the body
of your document so that we can contact you if we have questions
regarding your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rule'' and insert ``USCG-2011-0266'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit your comments by mail or hand delivery, submit
them in an unbound format, no larger than 8\1/2\ by 11 inches, suitable
for copying and electronic filing. If you submit comments by mail and
would like to

know that they reached the Facility, please enclose a stamped, self-
addressed postcard or envelope. We will consider all comments and
material received during the comment period and may change the rule
based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then become highlighted
in blue. In the ``Keyword'' box insert ``USCG-2011-0266'' and click
``Search.'' Click the ``Open Docket Folder'' in the ``Actions'' column.
You may also visit the Docket Management Facility in Room W12-140 on
the ground floor of the Department of Transportation West Building,
1200 New Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. We have an
agreement with the Department of Transportation to use the Docket
Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets 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 a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one on or before the end of the comment period, using one
of the four methods specified under ADDRESSES. Please explain why you
believe a public meeting would be beneficial. If we determine that one
would aid this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

Background and Purpose

    On September 24 and 25, 2011, the Chesapeake Bay Power Boat
Association will sponsor power boat races on the Patuxent River near
Solomons, MD. The event consists of offshore power boats racing in a
counter-clockwise direction on an irregularly-shaped course located
between the Governor Thomas Johnson Memorial (SR-4) Bridge and the U.S.
Naval Air Station Patuxent River, MD. The start and finish lines will
be located near the Solomon's Pier. A large spectator fleet is expected
during the event. Due to the need for vessel control during the event,
the Coast Guard will temporarily restrict vessel traffic in the event
area to provide for the safety of participants, spectators and other
transiting vessels.

Discussion of Proposed Rule

    The Coast Guard proposes to establish temporary special local
regulations on specified waters of the Patuxent River. The regulations
will be in effect from 10 a.m. on September 24, 2011 to 6 p.m. on
September 25, 2011. The regulated area, approximately 4,000 yards in
length and 1,700 yards in width, includes all waters of the Patuxent
River, within lines connecting the following positions: From latitude
38[deg]19'45'' N, longitude 076[deg]28'06'' W, thence to latitude
38[deg]19'24'' N, longitude 076[deg]28'30'' W, thence to latitude
38[deg]18'32'' N, longitude 076[deg]28'14'' W; and from latitude
38[deg]17'38'' N, longitude 076[deg]27'26'' W, thence to latitude
38[deg]18'00'' N, longitude 076[deg]26'41'' W, thence to latitude
38[deg]18'59'' N, longitude 076[deg]27'20'' W, located in Solomons,
Maryland.
    The effect of this proposed rule will be to restrict general
navigation in the regulated area during the event. Spectator vessels
will be allowed to view the event from a designated spectator area
within the regulated area, which will be located within a line
connecting the following positions: Latitude 38[deg]19'00'' N,
longitude 076[deg]28'22'' W, thence to latitude 38[deg]19'07'' N,
longitude 076[deg]28'12'' W, thence to latitude 38[deg]18'53'' N,
longitude 076[deg]27'55'' W, thence to latitude 38[deg]18'30'' N,
longitude 076[deg]27'45'' W, thence to latitude 38[deg]18'00'' N,
longitude 076[deg]27'11'' W, thence to latitude 38[deg]17'54'' N,
longitude 076[deg]27'20'' W, thence to the point of origin at latitude
38[deg]19'00'' N, longitude 076[deg]28'22'' W.
    Spectator vessels viewing the event outside the regulated area may
not block the navigable channel. Other vessels intending to transit the
Patuxent River will be allowed to safely transit around the regulated
area. These regulations are needed to control vessel traffic during the
event to ensure the safety of participants, spectators and transiting
vessels.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This rule is not a significant regulatory action under section 3(f)
of Executive Order 12866, Regulatory Planning and Review, as
supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of that Executive Order 12866
or under section 1 of Executive Order 13563. The Office of Management
and Budget has not reviewed it under that those Orders. We expect the
economic impact of this proposed rule to be so minimal that a full
Regulatory Evaluation under the regulatory policies and procedures of
DHS is unnecessary. Although this regulation will prevent traffic from
transiting a portion of the Patuxent River during the event, the effect
of this regulation will not be significant due to the limited duration
that the regulated area will be in effect and the extensive advance
notifications that will be made to the maritime community via the Local
Notice to Mariners and marine information broadcasts, so mariners can
adjust their plans accordingly. Additionally, the regulated area has
been narrowly tailored to impose the least impact on general navigation
yet provide the level of safety determined to be necessary. Vessel
traffic will be able to transit safely through a portion regulated
area, westward and southward of the spectator fleet area.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. 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 proposed
rule would not have a significant economic impact on a substantial
number of small entities. This proposed rule would affect the following
entities, some of which might be small entities: the owners or
operators of vessels intending to transit or anchor in the effected
portions of the Patuxent River during the event.
    Although this regulation prevents traffic from transiting a portion
of the Patuxent River at Solomons, MD during the event, this proposed
rule will not have a significant economic impact on a substantial
number of small entities

for the following reasons. This proposed rule would be in effect for
only a limited period. Though the regulated area extends across the
entire width of the river, vessel traffic will be able to transit
safely around the spectator fleet and race course areas within the
regulated area. Before the enforcement period, we will issue maritime
advisories so mariners can adjust their plans accordingly.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    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 proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact Coast Guard Sector Baltimore,
MD. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

Collection of Information

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

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

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 proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

Taking of Private Property

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

Civil Justice Reform

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

Protection of Children

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

Indian Tribal Governments

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

Energy Effects

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

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01 and Commandant Instruction
M16475.lD, which guide the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination 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 proposed rule
involves implementation of regulations within 33 CFR part 100
applicable to organized marine events on the navigable waters of the
United States that could negatively impact the safety of waterway users
and shore side activities in the event area. The category of water
activities includes but is not limited to sail boat regattas, boat
parades, power boat racing, swimming events, crew racing, canoe and
sail board racing. We seek any comments or information that may lead to
the discovery of a significant environmental impact from this proposed
rule.

List of Subjects in 33 CFR Part 100

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

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 100 as follows:

PART 100--SAFETY OF LIFE ON NAVIGABLE WATERS

    1. The authority citation for part 100 continues to read as
follows:

    Authority:  33 U.S.C. 1233.

    2. Add a temporary section, Sec.  100.35-T05-0266 to read as
follows:

Sec.  100.35-T05-0266  Special Local Regulations for Marine Events;
Patuxent River, Solomons, MD.

    (a) Regulated area. The following location is a regulated area: All
waters of the Patuxent River, within lines connecting the following
positions: from latitude 38[deg]19'45'' N, longitude 076[deg]28'06'' W,
thence to latitude 38[deg]19'24'' N, longitude 076[deg]28'30'' W,
thence to latitude 38[deg]18'32'' N, longitude 076[deg]28'14'' W; and
from latitude 38[deg]17'38'' N, longitude 076[deg]27'26'' W, thence to
latitude 38[deg]18'00'' N, longitude 076[deg]26'41'' W, thence to
latitude 38[deg]18'59'' N, longitude 076[deg]27'20'' W, located at
Solomons, Maryland. All coordinates reference Datum NAD 1983.
    (b) Definitions. (1) Coast Guard Patrol Commander means a
commissioned, warrant, or petty officer of the U.S. Coast Guard who has
been designated by the Commander, Coast Guard Sector Baltimore.
    (2) Official Patrol means any vessel assigned or approved by
Commander, Coast Guard Sector Baltimore with a commissioned, warrant,
or petty officer on board and displaying a Coast Guard ensign.
    (3) Participant means all vessels participating in the Chesapeake
Challenge under the auspices of the Marine Event Permit issued to the
event sponsor and approved by Commander, Coast Guard Sector Baltimore.
    (4) Spectator means all persons and vessels not registered with the
event sponsor as participants or official patrol.
    (c) Special local regulations. (1) The Coast Guard Patrol Commander
may forbid and control the movement of all vessels in the regulated
area. When hailed or signaled by an official patrol vessel, a vessel in
the regulated area shall immediately comply with the directions given.
Failure to do so may result in expulsion from the area, citation for
failure to comply, or both.
    (2) The Coast Guard Patrol Commander may terminate the event, or
the operation of any vessel participating in the event, at any time it
is deemed necessary for the protection of life or property.
    (3) All vessel traffic, not involved with the event, will be
allowed to transit the regulated area and shall proceed in a northerly
or southerly direction westward of the spectator area, taking action to
avoid a close-quarters situation with spectators, until finally past
and clear of the regulated area.
    (4) All Coast Guard vessels enforcing this regulated area can be
contacted on marine band radio VHF-FM channel 16 (156.8 MHz).
    (5) Only participants and official patrol are allowed to enter the
race course area.
    (6) Spectators are allowed inside the regulated area only if they
remain within the designated spectator area. Spectators will be
permitted to anchor within the designated spectator area. No vessel may
anchor within the regulated area outside the designated spectator area.
Spectators may contact the Coast Guard Patrol Commander to request
permission to pass through the regulated area. If permission is
granted, spectators must pass directly through the regulated area
outside the race course and spectator areas at a safe speed and without
loitering.
    (7) Designated spectator fleet area. The spectator fleet area is
located within a line connecting the following positions: Latitude
38[deg]19'00'' N, longitude 076[deg]28'22'' W, thence to latitude
38[deg]19'07'' N, longitude 076[deg]28'12'' W, thence to latitude
38[deg]18'53'' N, longitude 076[deg]27'55'' W, thence to latitude
38[deg]18'30'' N, longitude 076[deg]27'45'' W, thence to latitude
38[deg]18'00'' N, longitude 076[deg]27'11'' W, thence to latitude
38[deg]17'54'' N, longitude 076[deg]27'20'' W, thence to the point of
origin at latitude 38[deg]19'00'' N, longitude 076[deg]28'22'' W. All
coordinates reference datum NAD 83.
    (8) The Coast Guard will publish a notice in the Fifth Coast Guard
District Local Notice to Mariners and issue marine information
broadcast on VHF-FM marine band radio announcing specific event date
and times.
    (d) Enforcement periods. This section will be enforced from 10 a.m.
until 6 p.m. on September 24, 2011, and from 10 a.m. until 6 p.m. on
September 25, 2011.

    Dated: April 20, 2011.
Mark P. O'Malley,
Captain, U.S. Coast Guard, Captain of the Port Baltimore.
[FR Doc. 2011-15165 Filed 6-17-11; 8:45 am]
BILLING CODE 9110-04-P ?>


[Federal Register Volume 79, Number 106 (Tuesday, June 3, 2014)]
[Rules and Regulations]
[Pages 31857-31859]
[FR Doc No: 2014-12719]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2014-0336; Directorate Identifier 2013-SW-063-AD;
Amendment 39-17857; AD 2014-11-07]
RIN 2120-AA64

Airworthiness Directives; Agusta S.p.A Helicopters (Type
Certificate Currently Held by AgustaWestland S.p.A) (Agusta)

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Final rule; request for comments.

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SUMMARY: We are adopting a new airworthiness directive (AD) for Agusta
Model A109A, A109A II, A109C, A109E, A109K2, A109S, AW109SP, A119, and
AW119 MKII helicopters. This AD requires inspecting and replacing
certain part-numbered main rotor swashplate support nuts. This AD is
prompted by a report of two cracked nuts found on an A109S helicopter.
These actions are intended to detect a cracked nut and prevent failure
of the main rotor system, and subsequent loss of control of the
helicopter.

DATES: This AD becomes effective June 18, 2014.
    We must receive comments on this AD by August 4, 2014.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Docket: Go to http://www.regulations.gov. Follow the online instructions for sending your
comments electronically.
     Fax:<PHONE_NUMBER>.
     Mail: Send comments to the U.S. Department of
Transportation, Docket Operations, M-30, West Building Ground Floor,
Room W12-140, 1200 New Jersey Avenue SE., Washington, DC 20590-0001.
     Hand Delivery: Deliver to the ``Mail'' address between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov or in person at the Docket Operations Office
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the foreign authority's AD,
the economic evaluation, any comments received, and other information.
The street address for the Docket Operations Office (telephone 800-647-
5527) is in the ADDRESSES section. Comments will be available in the AD
docket shortly after receipt.
    For service information identified in this AD, contact
AgustaWestland, Product Support Engineering, Via del Gregge, 100, 21015
Lonate Pozzolo (VA) Italy, ATTN: Maurizio D'Angelo; telephone 39-0331-
664757; fax 39 0331-664680; or at http://www.agustawestland.com/technical-bulletins. You may review the referenced service information
at the FAA, Office of the Regional Counsel, Southwest Region, 2601
Meacham Blvd., Room 663, Fort Worth, Texas 76137.

FOR FURTHER INFORMATION CONTACT: Robert Grant, Aviation Safety
Engineer, Safety Management Group, FAA, 2601 Meacham Blvd., Fort Worth,
Texas 76137; telephone<PHONE_NUMBER>; email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

Comments Invited

    This AD is a final rule that involves requirements affecting flight
safety, and we did not provide you with notice and an opportunity to
provide your comments prior to it becoming effective. However, we
invite you to participate in this rulemaking by submitting written
comments, data, or views. We also invite comments relating to the
economic, environmental, energy, or federalism impacts that resulted
from adopting this AD. The most helpful comments reference a specific
portion of the AD, explain the reason for any recommended change, and
include supporting data. To ensure the docket does not contain
duplicate comments, commenters should send only one copy of written
comments, or if comments are filed electronically, commenters should
submit them only one time. We will file in the docket all comments that
we receive, as well as a report summarizing each substantive public
contact with FAA personnel concerning this rulemaking during the
comment period. We will consider all the comments we receive and may
conduct additional rulemaking based on those comments.

Discussion

    The European Aviation Safety Agency (EASA), which is the Technical
Agent for the Member States of the European Union, has issued EASA
Emergency AD No. 2013-0265-E, dated October 30, 2013, to correct an
unsafe condition for Agusta Model A109A, A109A II, A109C, A109E,
A109K2, A109LUH, A109S, AW109SP, A119, and AW119 MKII helicopters. EASA
advises that during a scheduled inspection of the rotating control
installation, two nuts, part number (P/N) MS21042-4, which connect the
swashplate support to the upper case of the main transmission were
found cracked. EASA states a subsequent investigation determined that
the cracks in the nuts resulted from a production deficiency, which
caused hydrogen embrittlement, at the nut manufacturer. EASA also
states that this condition, if not detected and corrected, could lead
to failure of the main rotor function and subsequent loss of control of
the helicopter. The EASA Emergency AD requires repetitive inspections
of each nut, P/N MS21042-4, for a crack, replacing any nut that has a
crack with a different part-numbered nut, and, within 3 months,
replacing each nut that does not have a crack with a different part-
numbered nut. EASA Emergency AD 2013-0265-E also prohibits installing a
nut, P/N MS21042-4, to connect the swashplate support to the upper case
on any helicopter.

FAA's Determination

    These helicopters have been approved by the aviation authority of
Italy and are approved for operation in the United States. Pursuant to
our bilateral agreement with Italy, EASA, its technical representative,
has notified us of the unsafe condition described in the EASA AD. We
are issuing this AD because we evaluated all information provided by
EASA and determined the unsafe condition exists and is likely to exist
or develop on other helicopters of these same type designs.

Related Service Information

    Agusta has issued Bollettino Tecnico (BT) No. 109-137 for Model
A109A, A109A II and A109C helicopters; BT No. 109EP-131 for Model A109E
helicopters; BT No. 109K-59 for Model A109K2 helicopters; BT No. 109S-
056 for Model A109S helicopters; BT No. 109SP-070 for Model AW109SP
helicopters; and BT No. 119-062 for Model A119 and AW119 MKII
helicopters. All of the BTs are Revision 0 and are dated October 29,
2013. Each BT describes procedures for inspecting

the nuts connecting the swashplate support to the upper case of the
main transmission for a crack and for replacing each nut, P/N MS21042-
4, with a nut, P/N NAS1805-4.

AD Requirements

    This AD requires, within 10 hours time-in-service (TIS), inspecting
each nut, P/N MS21042-4, which connects the swashplate support to the
upper case of the main transmission, for a crack. If there is a crack
on any nut, or within 25 hours TIS if there is not a crack, this AD
requires replacing each nut, P/N MS21042-4, connecting the swashplate
support to the upper case of the main transmission. This AD also
prohibits installing a nut, P/N MS21042-4, connecting the swashplate
support to the upper case of the main transmission on any helicopter.

Differences Between This AD and the EASA

    The EASA AD requires replacing each nut, P/N MS21042-4, within 3
months, while this AD requires replacing the nuts within 25 hours TIS.
The EASA AD also requires that each of the P/N MS21042-4 nuts be
replaced with P/N NAS1805-4 nuts and this AD does not. The EASA AD also
requires repetitive inspections of the P/N MS21042-4 nuts until they
can be replaced and this AD does not. This AD does not apply to Model
A109LUH helicopters as they are not type-certificated in the U.S.

Costs of Compliance

    We estimate that this AD affects 222 helicopters of U.S. Registry.
We estimate that operators may incur the following costs in order to
comply with this AD. At an average labor rate of $85 per work-hour,
inspecting the nuts connecting the swashplate support to the upper case
of the main transmission requires about .5 work-hour, for a cost per
helicopter of $43, and a total cost to U.S. operators of $9,546.
Replacing the nuts requires about 1 work-hour, and required parts cost
is minimal, for a cost per helicopter of $85 and a total cost to U.S.
operators of $18,870.

FAA's Justification and Determination of the Effective Date

    Providing an opportunity for public comments before adopting these
AD requirements would delay implementing the safety actions needed to
correct this known unsafe condition. Therefore, we find that the risk
to the flying public justifies waiving notice and comment before
adopting this rule because the required corrective actions must be done
within 10 hours TIS and 25 hours TIS, a very short time period based on
the average flight-hour utilization rate of these helicopters.
    Since an unsafe condition exists that requires the immediate
adoption of this AD, we determined that notice and opportunity for
public comment before issuing this AD are impracticable and that good
cause exists for making this amendment effective in less than 30 days.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. 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.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this AD will not have federalism implications
under Executive Order 13132. This AD will not have 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.
    For the reasons discussed, I certify that this AD:
    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);
    3. Will not affect intrastate aviation in Alaska to the extent that
it justifies making a regulatory distinction; and
    4. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared an economic evaluation of the estimated costs to comply
with this AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new airworthiness
directive (AD):

2014-11-07 Agusta S.p.A Helicopters (Type Certificate Currently Held
By AgustaWestland S.p.A) (Agusta): Amendment 39-17857; Docket No.
FAA-2014-0336; Directorate Identifier 2013-SW-063-AD.

(a) Applicability

    This AD applies to Agusta Model A109A, A109A II, A109C, A109E,
A109K2, A109S, AW109SP, A119, and AW119 MKII helicopters with a nut,
part-number (P/N) MS21042-4, connecting the main rotor swashplate
support to the upper case of the main transmission installed,
certificated in any category.

(b) Unsafe Condition

    This AD defines the unsafe condition as a crack on a nut
connecting the main rotor swashplate support to the upper case of
the main transmission. This condition could result in failure of the
main rotor system and subsequent loss of control of the helicopter.

(c) Effective Date

    This AD becomes effective June 18, 2014.

 (d) Compliance

    You are responsible for performing each action required by this
AD within the specified compliance time unless it has already been
accomplished prior to that time.

(e) Required Actions

    (1) Within 10 hours time-in-service (TIS), using a light,
visually inspect each nut, P/N MS21042-4, which connects the
swashplate support to the upper case of the main transmission for a
crack.
    (i) If there is a crack, before further flight, remove all six
nuts, P/N MS21042-4, connecting the swashplate support to the upper
case.
    (ii) If there are no cracks, within 25 hours TIS, remove all six
nuts, P/N MS21042-4, connecting the swashplate support to the upper
case.
    (2) Do not install a nut, P/N MS21042-4, connecting the
swashplate support to the upper case of the main transmission on any
helicopter.

(f) Alternative Methods of Compliance (AMOCs)

    (1) The Manager, Safety Management Group, Rotorcraft
Directorate, FAA, may

approve AMOCs for this AD. Send your proposal to: Robert Grant,
Aviation Safety Engineer, Safety Management Group, FAA, 2601 Meacham
Blvd., Fort Worth, Texas 76137; telephone<PHONE_NUMBER>; email
<EMAIL_ADDRESS>    (2) For operations conducted under a 14 CFR part 119 operating
certificate or under 14 CFR part 91, subpart K, we suggest that you
notify your principal inspector, or lacking a principal inspector,
the manager of the local flight standards district office or
certificate holding district office, before operating any aircraft
complying with this AD through an AMOC.

(g) Additional Information

    (1) Agusta Bollettino Tecnico (BT) No. 109-137 for Model A109A,
A109A II and A109C helicopters; BT No. 109EP-131 for Model A109E
helicopters; BT No. 109K-59 for Model A109K2 helicopters; BT No.
109S-056 for Model A109S helicopters; BT No. 109SP-070 for Model
AW109SP helicopters; and BT No. 119-062 for Model A119 and AW119
MKII helicopters, all Revision 0 and dated October 29, 2013, which
are not incorporated by reference, contain additional information
about the subject of this AD. For service information identified in
this AD, contact AgustaWestland, Product Support Engineering, Via
del Gregge, 100, 21015 Lonate Pozzolo (VA) Italy, ATTN: Maurizio
D'Angelo; telephone 39-0331-664757; fax 39-0331-664680; or at http://www.agustawestland.com/technical-bullettins. You may review a copy
of the service information at the FAA, Office of the Regional
Counsel, Southwest Region, 2601 Meacham Blvd., Room 663, Fort Worth
Texas 76137.
    (2) The subject of this AD is addressed in European Aviation
Safety Agency (EASA) Emergency AD No. 2013-0265-E, dated October 30,
2013. You may view the EASA AD on the internet at http://www.regulations.gov in Docket No. FAA-2014-0336.

(h) Subject

    Joint Aircraft Service Component (JASC) Code: 6200 Main Rotor
System.

    Issued in Fort Worth, Texas, on May 21, 2014.
Lance T. Gant,
Acting Directorate Manager, Rotorcraft Directorate, Aircraft
Certification Service.
[FR Doc. 2014-12719 Filed 6-2-14; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register Volume 86, Number 55 (Wednesday, March 24, 2021)]
[Notices]
[Pages 15685-15686]
[FR Doc No: 2021-06053]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-1862]

The Drug Supply Chain Security Act Pilot Project Program and
Enhanced Drug Distribution Security; Public Meeting; Reopening of the
Comment Period

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; reopening of the comment period.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
reopening the comment period for the notice entitled ``The Drug Supply
Chain Security Act Pilot Project Program and Enhanced Drug Distribution
Security; Public Meeting; Request for Comments'' that appeared in the
Federal Register of October 28, 2020. The Agency is taking this action
to allow interested persons additional time to submit comments.

DATES: FDA is reopening the comment period for the notice published on
October 28, 2020 (85 FR 68342). Submit either electronic or written
comments by June 22, 2021 to ensure that the Agency considers your
comment.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before June 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of June 22, 2021. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.

Electronic Submissions

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

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2020-N-1862 for ``The Drug Supply Chain Security Act Pilot Project
Program and Enhanced Drug Distribution Security; Public Meeting;
Reopening of Comment Period.'' Received comments, those filed in a
timely manner (see ADDRESSES), will be placed in the docket and, except
for those submitted as ``Confidential Submissions,'' publicly viewable
at https://www.regulations.gov or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The

Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. If you do not wish your name and contact information to be made
publicly available, you can provide this information on the cover sheet
and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Kristle Green, Office of Compliance,
Center for Drug Evaluation and Research, Food and Drug Administration,
10903 New Hampshire Ave., Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In the Federal Register of October 28, 2020
(85 FR 68342), FDA published a notice with a 60-day comment period to
announce and request comments on a virtual public meeting entitled
``The Drug Supply Chain Security Act Pilot Project Program and Enhanced
Drug Distribution Security'' held on December 8 and 9, 2020. FDA is
reopening the comment period until June 22, 2021.
    The Agency believes that an additional 90 days will allow adequate
time for interested persons to submit comments. Materials from the
public meeting are on FDA's website at https://www.fda.gov/drugs/news-events-human-drugs/drug-supply-chain-security-act-pilot-project-program-and-enhanced-drug-distribution-security.

    Dated: March 19, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-06053 Filed 3-23-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: November 27, 2007 (Volume 72, Number 227)]
[Notices]
[Page 66164]
[DOCID:fr27no07-74]

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

DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. PR07-12-002]

Enterprise Texas Pipeline LLC; Notice of Compliance Filing

November 19, 2007.
    Take notice that on November 13, 2007, Enterprise Texas Pipeline
LLC filed a Report of Refunds in compliance with the Commission's
letter order issued on September 4, 2007 in Docket Nos. PR07-12-000 and
PR07-12-001.
    Any person desiring to protest this filing must file in accordance
with Rule 211 of the Commission's Rules of Practice and Procedure (18
CFR 385.211). Protests to this filing will be considered by the
Commission in determining the appropriate action to be taken, but will
not serve to make protestants parties to the proceeding. Such protests
must be filed on or before the date as indicated below. Anyone filing a
protest must serve a copy of that document on all the parties to the
proceeding.
    The Commission encourages electronic submission of protests in lieu
of paper using the ``eFiling'' link at http://www.ferc.gov. Persons

unable to file electronically should submit an original and 14 copies
of the protest to the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426.
    This filing is accessible on-line at http://www.ferc.gov, using the

``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the Web site that enables subscribers to receive e-mail
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please e-mail
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For

TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time, Monday, November 26, 2007.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-23040 Filed 11-26-07; 8:45 am]

BILLING CODE 6717-01-P


The range of quantified benefits increases significantly with Alternatives 2 and 3. However, the associated costs also increase significantly. ( Cost figures in Exhibit ES. 9 show estimated values between $ 384 and $ 682 million per year.) Although the benefits for Alternatives 2 and 3 are potentially significant, the M DBP Advisory Committee did not favor this alternative because it believed that the current health effects data are not certain enough to warrant such a potentially expensive regulation.

9.4.3 Cost Effectiveness Evaluation of the relative merits of one alternative over another is often made with respect to cost effectiveness. This concept can be defined simply as getting the greatest benefits for a given expenditure or imposing the least cost for a given level of benefits. Exhibit 9.11 depicts the annualized value of estimated benefits and costs for the four alternatives at a 3 percent discount rate ( comparisons at a 7 percent discount rate would look similar; thus they were not included, for brevity). Four estimates of average monetized benefits are shown, representing 2 and 17 percent PAR estimates and WTP for curable lymphoma and chronic bronchitis as the basis for valuing non fatal bladder cancer cases avoided.

For each alternative, the mean of its benefit estimate is graphed. At that level of benefits, there is a corresponding cost estimate shown. The trend line connects the mean estimates of benefits and costs for each alternative. These graphs help to show the concept of cost effectiveness and to compare the alternatives. In Exhibit 9.11, any alternative to the right of and below the other alternatives would be more cost effective and " dominate" alternatives that provide fewer benefits at higher costs.

The alternatives shown in Exhibit 9.11 map the boundaries of the cost effective alternatives. In addition to allowing a visual test of cost effectiveness, the exhibit shows information about the incremental benefits of each alternative. Compared to Alternative 1, the Preferred Alternative achieves comparable benefits at a relatively lower cost. Alternatives 3 and 4 achieve much greater benefits, at dramatically higher incremental cost. The Preferred Alternative appears to be the best value; other alternatives have either higher costs for nearly the same level of benefits ( Alternative 1) or much greater benefits, at dramatically higher costs ( Alternatives 3 and 4). Economic Analysis for the Stage 2 DBPR Proposal 9 13 July 2003 2% PAR value, WTP for Lymphoma $ 0 $ 100 $ 200 $ 300 $ 400 $ 500 $ 600 $ 700 $ 0 $ 100 $ 200 $ 300 $ 400 $ 500 $ 600 $ 700 $ 800 $ 900 $ 1,000 Benefits ($ Millions) Costs ($ Millions)

Preferred Alternative Alternative 1 Alternative 2 Alternative 3 17% PAR Value, WTP for Lymphoma $ 0 $ 100 $ 200 $ 300 $ 400 $ 500 $ 600 $ 700 $ 0 $ 1,000 $ 2,000 $ 3,000 $ 4,000 $ 5,000 $ 6,000 $ 7,000 $ 8,000 $ 9,000 Benefits ($ Millions) Costs ($ Millions)

Preferred Alternative Alternative 1 Alternative 2 Alternative 3 Exhibit 9.11 Comparison of Annualized Costs and Benefits for the Stage 2 Regulatory Alternatives ( 3 % Discount Rate) Economic Analysis for the Stage 2 DBPR Proposal 9 14 July 2003 2% PAR value, WTP for Bronchitis $ 0 $ 100 $ 200 $ 300 $ 400 $ 500 $ 600 $ 700 $ 0 $ 100 $ 200 $ 300 $ 400 $ 500 $ 600 $ 700 $ 800 $ 900 $ 1,000 Benefits ($ Millions) Costs ($ Millions)

Preferred Alternative Alternative 1 Alternative 2 Alternative 3 17% PAR value, WTP for Bronchitis $ 0 $ 100 $ 200 $ 300 $ 400 $ 500 $ 600 $ 700 $ 0 $ 1,000 $ 2,000 $ 3,000 $ 4,000 $ 5,000 $ 6,000 $ 7,000 $ 8,000 $ 9,000 Benefits ($ Millions) Costs ($ Millions)

Preferred Alternative Alternative 1 Alternative 2 Alternative 3 Exhibit 9.11 Comparison of Annualized Costs and Benefits for the Stage 2 Regulatory Alternatives ( 3 % Discount Rate) ( Continued) Economic Analysis for the Stage 2 DBPR Proposal 9 15 July 2003 2% PAR Estimate 17% PAR Estimate 2% PAR Estimate 17% PAR Estimate Preferred Alt. 1 Alt. 2 Alt. 3 Preferred 2.8 $ 0.3 $ 3.1 $ 0.4 $ Alt. 1 8.4 $ 1.0 $ 9.0 $ 1.0 $ Alt. 2 3.0 $ 0.3 $ 3.3 $ 0.4 $ Alt. 3 3.7 $ 0.4 $ 4.0 $ 0.5 $

Preferred Alt. 1 Alt. 2 Alt. 3 Causality has not been established, and numbers and types of cases avoided, as well as the value of such cases, were not quantified in the primary benefits analysis. Given the numbers of women of child bearing age exposed ( 58 million), the evidence indicates that the number of cases and the value of preventing those cases could be significant. See results of the illustrative calculation in Section 5.9 Avoided Adverse Reproductive and Developmental Health Effects N/ A Benefit Category DBP Surrogate Qualitative assessment indicates that the value of other health benefits could be positive and significant. Cost Per Case Avoided ( 7% Discount Rate)

Avoided Cases of Bladder Cancer Other Health and Non Health Effects Avoided N/ A Cost Per Case Avoided ( 3% Discount Rate)

Rule Alternative TTHM Note: Values presented in figures are annualized present values in year 2000 dollars. Estimates are discounted to 2003. Source: Exhibits 9.9 and 9.10. For the Stage 2 DBPR alternatives, cost effectiveness may also be evaluated in terms of the cost for each case avoided. EPA has performed this analysis for the quantified benefits of the Stage 2 DBPR. Although a similar analysis cannot be made for the unquantified benefits of the rule, it is expected that the results would follow the same general pattern. For purposes of evaluating cost effectiveness, the lower the cost per case avoided, the more cost effective the alternative is believed to be. Exhibit 9.12 presents the cost per case avoided for each regulatory alternative.

Exhibit 9.12 shows that the lowest estimate of cost per case avoided for the Preferred Alternative is always lower than or equal to the lowest estimate of cost per case avoided for the other alternatives, indicating that the Preferred Alternative is the most cost effective by this measure. Alternatives 2 and 3 have costs per case avoided closest to those of the Preferred Alternative. However, as discussed in the evaluation above, there are overriding issues regarding cost in relation to the uncertainty in the health effects data that led EPA to select the Preferred Alternative. The remaining alternative ( Alternative 1) is the least cost effective by the measure of cost per illness avoided and also has other overriding concerns ( i. e., the possible compromising of microbial protection).

Exhibit 9.12 Comparison of Estimated Cost Per Case Avoided for the Regulatory Alternatives ($ Millions, 2000$)

Notes: Cost per case avoided values represent present values in year 2000 dollars ($ Millions). Estimates are discounted to 2003.

Source: Derived from estimated cases avoided and national annualized costs presented in Exhibits 9.9 and 9.10. Economic Analysis for the Stage 2 DBPR Proposal 9 16 July 2003 9.5 Summary of Conclusions The following is a summary of the important points that must be considered when weighing the benefits and costs of the Stage 2 DBPR.

1) The quantified benefits estimate is potentially understated because it does not include the benefits for reductions in adverse reproductive and developmental health effects, other health effects, and non health effects associated with DBP reduction ( Exhibits 9.1 and 9.10). At the same time, EPA recognizes that the low end of the quantified benefits estimates could be as low as zero since causality has not yet been established between exposure to chlorinated water and bladder cancer.

2) The mean cost estimate of $ 59.1 ( 3 percent discount rate) to $ 64.6 million ( 7 percent discount rate) represents EPA's best estimate of the monetary impacts of the Stage 2 DBPR. In addition, sensitivity analyses reflecting uncertainties in IDSE predictions show that, for any potential higher cost estimate, there will likely be an even greater increase in the benefits ( Exhibits 9.5 and 9.6).

3) The Preferred Alternative provides the greatest benefits at a cost level that is considered reasonable ( i. e., is not cost prohibitive) given the uncertainties in health effects data. Although Alternatives 2 and 3 have a greater benefit, EPA rejected these alternatives because it is believed that the health effects data are not certain enough to warrant such expensive regulations ( Exhibits 9.9 and 9.10).

4) Evaluation of the cost effectiveness of the Preferred Alternative shows it to be the most effective according to the measures evaluated ( Exhibits 9.11 and 9.12).

5) The breakeven points for the estimated costs associated with the Stage 2 DBPR range from 12 to 13 annual bladder cancer cases using the WTP for lymphoma as the basis for valuing non fatal cancer cases, and 25 to 27 annual bladder cancer cases using the WTP for chronic bronchitis as the basis for valuing non fatal cases. These are near the low end of the range of estimated bladder cancer cases avoided ( 21 to 182).

As a result of all these considerations, EPA believes that the annual benefits of the Stage 2 DBPR will likely exceed the annualized national costs and will be effective in minimizing the risks to consumers from exposure to DBPs in drinking water. Economic Analysis for the Stage 2 DBPR Proposal R 1 July 2003 References About Infertility. 2000. In Vitro Fertilization and Embryo Transfer ( IVF/ ET). http:// www. infertility. about. com.

Abma, J., Chandra, A., Mosher, W., Peterson, L., and Piccinino, L. 1997. Fertility, family planning, and women's health: New Data from the 1995 National Survey of Family Growth. National Center for Health Statistics. Vital and Health Statistics, 23( 19).

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Bove F. J., Shim, Y., and Zeitz, P. 2002. Drinking Water Contaminants and Adverse Pregnancy Outcomes: A Review. Environmental Health Perspectives, 110( Suppl. 1): 61 74. Economic Analysis for the Stage 2 DBPR Proposal R 2 July 2003 Bried, E. M. and Scheffler, R. M. 1992. The Financial Stages of Cancer in the Elderly. Oncology Supplement 6( 2).

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Cantor, K. P., Lunch, C. F., Hildesheim, M., Dosemeci, M., Lubin, J., Alavanja, M., and Craun, G. F. 1998. Drinking Water Source and Chlorination Byproducts I. Risk of Bladder Cancer. Epidemiology, 9: 21 28.

Cantor, K. P, Lynch, C. F., Hildesheim, M. E., Dosemeci, M., Lubin, J., Alavanja, M., and Craun, G. 1999. Drinking water source and chlorination byproducts in Iowa. III. Risk of brain cancer. Am J Epidemiol, 150( 6): 552 560.

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Chestnut, L. G., Alberni, A., and Mills, D. 1997. Monetary Valuation of Human Mortality Risks in Cost Benefit Analyses of Environmental Programs. Prepared for U. S. EPA, Office of Policy Planning and Evaluation. EPA Contract No. 68 W6 0055. September 30, 1997.

Christian, M. S., York, R. G., Hoberman, A. M., Diener, R. M., and L. C. Fisher. 2001a. Oral ( drinking water) developmental toxicity studies of bromodichloromethane ( BDCM) in rats and rabbits. International Journal of Toxicology, 20( 4): 225 237.

Christian, M. S., York, R. G., Hoberman, A. M., Diener, R. M., L. C. Fisher, and G. A. Gates. 2001b. Biodisposition of dibromoacetic acid ( DBA) and bromodichloromethane ( BDCM) administered to rats and rabbits in drinking water during range finding reproduction and developmental toxicity studies. International Journal of Toxicology, 20( 4): 239 253.

Christian, M. S., York, R. G., Hoberman, A. M., Diener, R. M., L. C. Fisher, and W. R. Brown. 2002a. Oral ( drinking water) two generation reproductive toxicity study of bromodichloromethane ( BDCM) in rats. International Journal of Toxicology. 21: 115 146.

Christian, M. S., York, R. G., Hoberman, A. M., Frazee, L. C., Fisher, L. C., Brown, W. R., and D. M. Creasy. 2002b. Oral ( Drinking Water) two generation reproductive toxicity study of dibromoacetic acid ( DBA) in rats. International Journal of Toxicology. In press. Economic Analysis for the Stage 2 DBPR Proposal R 3 July 2003 Corley, R. A., Gordon, S. M., Wallace, L. A. 2000. Physiologically Based Pharmacokinetic Modeling of the Temperature dependent Dermal Absorption of Chloroform by Humans Following Bath Water Exposures. Toxicol Sci, 53( 1): 13 23.

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