[Federal Register Volume 76, Number 138 (Tuesday, July 19, 2011)]
[Rules and Regulations]
[Pages 42545-42549]
[FR Doc No: 2011-18044]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 165

[Docket No. USCG-2011-0536]
RIN 1625-AA11

Regulated Navigation Area; Chelsea Street Bridge Construction,
Chelsea, MA

AGENCY: Coast Guard, DHS.

ACTION: Temporary interim rule with request for comments.

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SUMMARY: The United States Coast Guard is establishing a regulated
navigation area (RNA) on the navigable waters of the Chelsea River
under and surrounding the Chelsea Street Bridge (CSB) that crosses the
Chelsea River between East Boston and Chelsea, Massachusetts. This
temporary interim rule allows the Coast Guard to suspend all vessel
traffic within the RNA for construction operations, both planned and
unforeseen, that could pose an imminent hazard to vessels operating in
the area. This rule is necessary to provide for the safety of life on
the navigable waters during the construction of the Chelsea Street
Bridge.

DATES: This rule is effective in the CFR on July 19, 2011 through May
31, 2012. This rule is effective with actual notice for purposes of
enforcement on July 8, 2011.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-0536 using any one of the following methods:
    (1) Federal e-Rulemaking 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.
    Documents indicated in this preamble as being available in the
docket are part of docket USCG-2011-0536 and are available online by
going to http://www.regulations.gov, inserting USCG-2011-0536 in the
``Keyword'' box, and then clicking ``Search.'' They are also available
for inspection or copying at the Docket Management Facility (M-30),
U.S. Department of Transportation, West Building Ground Floor, Room
W12-140, 1200 New Jersey Avenue, SE., Washington, DC 20590, between 9
a.m. and 5 p.m., Monday through Friday, except Federal holidays.

FOR FURTHER INFORMATION CONTACT: If you have questions on this
temporary rule, call or e-mail MST1 David Labadie of the Waterways
Management Division, U.S. Coast Guard Sector Boston; telephone 617-223-
3010, e-mail<EMAIL_ADDRESS>If you have questions on viewing
the docket, call Renee V. Wright, Program Manager, Docket Operations,
telephone<PHONE_NUMBER>.

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.
    As this interim rule will be in effect before the end of the
comment period, the Coast Guard will evaluate and revise this rule as
necessary to address significant public comments.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-0536), 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 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-2011-0536'' in the ``Keyword'' box.
Click ``Search'' then click on the balloon shape in the ``Actions''
column. If you submit 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
this 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-2011-0536'' 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 in connection with the
public comment period for this interim rule. But you may submit a
request for one 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. Although they were not held specifically to solicit public
comments on this interim rule, and were not announced in the Federal
Register, the Coast Guard has held or participated in multiple locally
announced informal waterway user meetings where waterway closures and
restrictions were discussed, and we anticipate holding one or more
additional informal meetings, with opportunity for public questions or
comments, during the bridge construction. We will provide written
summaries of any such meetings in the docket.

Regulatory Information

    The Coast Guard is issuing this interim rule without prior Federal
Register notice 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 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
rule because the need for waterway closures was not brought to the
attention of the Coast Guard until April 5, 2011. Concerned that the
initial waterway closures proposed by J.F. White Contracting Company
might have a significant impact on waterway users, it was necessary for
the Coast Guard to move quickly to protect public safety. There was
insufficient time and therefore it was impracticable to issue an NPRM
and conduct a prior notice and comment period. We held informal
planning meetings at which the construction plans were presented to and
discussed with waterway users; stakeholder comments and concerns were
identified and many have been incorporated into this regulation. To
view the stakeholder comments and concerns see the CSB meeting minutes
in the docket. This rule is necessary to protect the safety of both the
construction crew and the waterway users operating in the vicinity of
the bridge construction zone. A delay or cancellation of the ongoing
bridge maintenance in order to accommodate a full notice and comment
period would be contrary to the public interest as it would delay
necessary operations thus prolonging the time that construction barges
and equipment would be in this location. Additionally, the dynamic
nature of the construction process and multitude of construction
vessels necessitate that all mariners navigate at a safe speed within
the RNA in accordance with Rule 6 of the Inland Navigation Rules, as
the barge and construction equipment configuration may change on a
daily basis. In order to address any further public concerns, this rule
is available for public comment until September 19, 2011. At that time
the Coast Guard will publish an amended rule if necessary to address
public concerns.
    Under 5 U.S.C. 553(d)(3), the Coast Guard finds that good cause
exists for making this rule effective less than 30 days after
publication in the Federal Register, as immediate action is needed to
protect vessels transiting the area from hazards imposed by
construction barges and equipment on the Chelsea River under and
surrounding the Chelsea Street Bridge, Chelsea, MA. Any delay in the
effective date of this rule would be contrary to the public interest as
immediate action is necessary to close the channel as needed from July
8, 2011 to May 31, 2012. These closures are necessary in order to
protect vessels transiting in the area from hazards imposed by
construction barges and equipment and to expedite the removal of the
old Chelsea St. Bridge and construction of the new bridge and fender
system.

Basis and Purpose

    Under the Ports and Waterways Safety Act, the Coast Guard has the
authority to establish RNAs in defined water areas that are determined
to have hazardous conditions and in which vessel traffic can be
regulated in the interest of safety. See 33 U.S.C. 1231 and Department
of Homeland Security Delegation No. 0170.1.
    The construction of the Chelsea Street Bridge involves large
machinery and construction vessel operations above and in the navigable
waters of the Chelsea River. The ongoing operations are, by their
nature, hazardous and pose risks both to recreational and commercial
traffic as well as the construction crew. In order to mitigate the
inherent risks involved in the construction, it is necessary to control
vessel movement through the area.
    The purpose of this rule is to ensure the safety of waterway users,
the public, and construction workers for the duration of the Chelsea
Street Bridge construction from July 8, 2011 through May 31, 2012. The
RNA will also protect vessels desiring to transit the area by ensuring
that vessels are only permitted to transit when it is safe to do so.

Discussion of Rule

    This action is intended to prohibit vessel traffic on a portion of
the Chelsea River, when necessary for the safety of navigation, while
construction equipment works in the channel on demolition of the
existing bridge and construction of its replacement. The Coast Guard
may close the area prescribed in this rule to all vessel traffic during
any circumstance, planned or unforeseen, that poses an imminent threat
to waterway users operating in the area. Complete waterway closures
will be made with as much advance notice as possible.
    The Coast Guard has discussed this project at length with the
construction

contractor, J.F. White Contracting Company, to identify if the project
can be completed without channel closures and, if possible, what impact
that would have on the project timeline. Through these discussions, it
became clear that while the majority of construction activities during
the span of this project would not require waterway closures, there are
certain tasks that can only be completed in the channel and will
require closing the waterway. J.F. White issued a letter on April 5,
2011 detailing the required channel work phases that will need waterway
closures.
    There are currently two planned and ten proposed channel closure
periods which are outlined below:
    The first planned closure period will be from September 28-30,
2011, and will coincide with the launching of the new bridge truss.
    The second planned closure will be from October 7-9, 2011 and will
coincide with the concrete bridge deck placement.
    There will be four proposed closure periods on dates to be
determined between October and December 2011 for the installation of
new bulkheads along both sides of the Chelsea River.
    The fifth and sixth proposed closure periods will take place in
January 2012 for the demolition of the fendering system and the
dredging on the Chelsea, MA side of the Chelsea River. These will be
for 15-day periods and will be intermittent closures.
    The seventh proposed closure period will take place in February
2012 for the installation of new aids to navigation on the Chelsea, MA
side of the Chelsea River and will be a 7-day period with intermittent
closures.
    The eighth and ninth proposed closure periods will take place in
February and March of 2012 for the demolition of the fendering system
and the dredging on the E. Boston, MA side of the Chelsea River. These
will be for 15-day periods and will be intermittent closures.
    The tenth proposed closure period will take place in March 2012 for
the installation of new aids to navigation on the E. Boston, MA side of
the Chelsea River and will be a 7-day period with intermittent
closures.
    The project is expected to be complete in April 2012 but this rule
will be made effective through the end of May 2012 to account for any
unforeseen construction delays.
    On a case-by-case basis, depending on the construction schedule,
J.F. White may request a waterway closure on various dates from July 8,
2011 through May 31, 2012. As discussed below, J.F White will notify
the Coast Guard of planned activities as soon as possible; preferably
four weeks in advance of any event.
    The Coast Guard will notify the maritime community of planned
waterway closure dates via Marine Information Broadcasts, Coast Guard
Local Notices to Mariners and Marine Safety Information Bulletins.
    Closure periods listed above will be made available to J. F. White
Contracting Company with the understanding that the construction
schedule as well as weather and tide conditions may not allow them to
use all closures. For that reason, J. F. White will notify the Coast
Guard of planned activities as soon as possible and preferably four
weeks in advance. Closure periods similar to those outlined above
should be expected throughout the duration of this rule. Additionally,
during the winter and into the early spring of 2012 there will certain
tasks (i.e. bulkhead and Aids to Navigation installation) that will
require a more than 24-hour closure as well as several 15-day long, 12
hour closures to complete the demolition of fender systems and dredging
operations. Once these closure periods are identified they will be
published with the widest distribution among the affected segments of
the public. Such means of notification will include, but is not limited
to, Broadcast Notice to Mariners and Local Notice to Mariners. Entry
into this RNA during a closure is prohibited unless authorized by the
Sector Boston Captain of the Port (COTP). In the event of an emergency
all construction equipment shall be removed from the channel to allow
for emergency vessels to pass (i.e., Fire Rescue Boat, Marine Police
Boat, or Environmental Response Boat).
    The implementation of this RNA does not negate the fact that the
Inland Rules of the Road as found in 33 CFR part 84 (subchapter E) must
be strictly adhered to. Mariners are strongly urged to monitor VHF
channel 13 when transiting the area and to communicate with fellow
mariners to facilitate movement and/or passing arrangements within the
channel.
    Any violation of the RNA described herein is punishable by, among
others, civil and criminal penalties, in rem liability against the
offending vessel, and the initiation of suspension or revocation
proceedings against Coast Guard-issued merchant-mariner credentials.
    The Sector Boston Captain of the Port will cause notice of
enforcement, suspension of enforcement, or closure of this RNA to be
made by all appropriate means to affect the widest distribution among
the affected segments of the public. Such means of notification will
include, but is not limited to, Notice of Enforcement published in the
Federal Register, Broadcast Notice to Mariners and Local Notice to
Mariners.

Regulatory Analyses

    We developed this 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.

Executive Order 12866 and Executive Order 13563

    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, and does not require an
assessment of potential costs and benefits under section 6(a)(3) of
that Order. The Office of Management and Budget has not reviewed it
under that Order.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this 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 rule will
not have a significant economic impact on substantial number of small
entities. This rule will affect the following entities some of which
may be small entities: The owners or operators of marinas, charter
fishing vessels and commercial fishing vessels who intend to transit in
those portions of the Chelsea River between July 8, 2011 and May 31,
2012.
    This regulation may have some impact on the public, but the
potential impact will be minimized for the following reasons: The area
of the closure is not likely to be transited by pleasure craft and they
will be able to operate on all other portions of the Chelsea River not
covered by the RNA. Additionally, many parties that have the potential
to be affected have been involved in the discussions and have made
plans to work around the closure times. Marine radio broadcasts
informing the public of any closures made by the RNA will be made
before,

during, and at the conclusion of the RNA closure enforcement periods.
    Although the RNA will apply to the entire width of the river, under
and surrounding the Chelsea Street Bridge traffic will be allowed to
pass through the area with the permission of the COTP. Before the
effective period, we will issue maritime advisories widely available to
users of the river.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we offer to assist small
entities in understanding the rule so that they can better evaluate its
effects on them and participate in the rulemaking process. If this rule
would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please call LT Judson Coleman, Prevention
Department, Sector Long Island Sound, at<PHONE_NUMBER>.
    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.

Collection of Information

    This rule calls 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 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 rule will not result in
such expenditure, we do discuss the effects of this rule elsewhere in
this preamble.

Taking of Private Property

    This rule will 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 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 rule under Executive Order 13045, Protection
of Children from Environmental Health Risks and Safety Risks. This rule
is not an economically significant rule and does not create an
environmental risk to health or risk to safety that may
disproportionately affect children.

Indian Tribal Governments

    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.

Energy Effects

    We have analyzed this 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 rule does not use technical standards. Therefore, we did not
consider the use of voluntary consensus standards.

Environment

    We have analyzed this rule under Department of Homeland Security
Management Directive 023-01 and Commandant Instruction M16475.lD, which
guide the Coast Guard in complying with the National Environmental
Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and have concluded
this action is one of a category of actions which do not individually
or cumulatively have a significant effect on the human environment.
This rule is categorically excluded, under figure 2-1, paragraph
(34)(g), of the Instruction. This rule involves the establishing of a
regulated navigation area and therefore falls within the categorical
exclusion noted above. An environmental analysis checklist and a
categorical exclusion determination are available in the docket where
indicated under ADDRESSES. Any comments received concerning
environmental impacts will be considered and changes made to the
environmental analysis checklist and categorical exclusion
determination as appropriate.

List of Subjects in 33 CFR Part 165

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

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

PART 165--REGULATED NAVIGATION AREAS AND LIMITED ACCESS AREAS

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

    Authority:  33 U.S.C. 1226, 1231; 46 U.S.C. Chapter 701, 50
U.S.C. 191, 195; 33 CFR 1.05-1, 6.04-1, 6.04-6, and 160.5; Pub. L.
107-295, 116 Stat. 2064; Department of Homeland Security Delegation
No. 0170.1.

0
2. Add Sec.  165.T01-0536 to read as follows:

Sec.  165.T01-0536  Regulated Navigation Area; Chelsea Street Bridge
Construction, Chelsea, MA.

    (a) Location. The following area is a regulated navigation area:
All navigable waters of the Chelsea River in Chelsea, MA, from surface
to bottom, within the following points (NAD 83): from 42[deg]23.10' N,
071[deg]01.26' W; thence to 42[deg]23.15' N, 071[deg]01.20' W; thence
to 42[deg]23.10' N, 071[deg]01.17' W; thence to 42[deg]23.07' N,
071[deg]01.24' W; thence back to the first point.
    (b) Regulations. (1) The general regulations contained in 33 CFR
165.10, 165.11, and 165.13 apply.
    (2) In accordance with the general regulations, entering into,
transiting through, mooring or anchoring within this regulated area is
prohibited unless authorized by the Captain of the Port (COTP) Boston.
    (3) All persons and vessels must comply with the Coast Guard
Captain of the Port or the designated on-scene patrol personnel.
    (4) Upon being hailed by a U.S. Coast Guard vessel by siren, radio,
flashing light or other means, the operator of the vessel must proceed
as directed.
    (5) Vessels may request permission to enter the zone during periods
of enforcement on VHF-16 or via phone at<PHONE_NUMBER>.
    (6) All other relevant regulations, including but not limited to
the Rules of the Road (33 CFR part 84--Subchapter E, Inland
Navigational Rules) remain in effect within the regulated area and
should be strictly followed at all times.
    (c) Effective Period. This rule is effective from July 8, 2011 to
11:59 p.m. on May 31, 2012.
    (d) Enforcement Period. (1) This regulated navigation area is
enforceable 24 hours a day from July 8, 2011 until May 31, 2012.
    (2) Notice of suspension of enforcement. If enforcement is
suspended, the COTP will cause a notice of the suspension of
enforcement by all appropriate means to affect the widest publicity
among the affected segments of the public. Such means of notification
may also include, but are not limited to, Broadcast Notice to Mariners
and Local Notice to Mariners. Such notification will include the date
and time that enforcement is suspended as well as the date and time
that enforcement will resume.
    (3) Notice of waterway closure. In the event of a complete waterway
closure, the COTP will make advance notice of the closure by all means
available to affect the widest public distribution including, but not
limited to, Broadcast Notice to Mariners and Local Notice to Mariners.
Such notification will include the date and time of the closure as well
as the date and time that normal vessel traffic can resume.
    (4) Violations of this regulated navigation area may be reported to
the COTP Sector Boston, at<PHONE_NUMBER> or on VHF-Channel 16.

    Dated: July 7, 2011.
J.B. McPherson,
Captain, U.S. Coast Guard, Acting Commander, First Coast Guard
District.
[FR Doc. 2011-18044 Filed 7-18-11; 8:45 am]
BILLING CODE 9110-04-P


[Federal Register: December 22, 2008 (Volume 73, Number 246)]
[Notices]
[Page 78371]
[DOCID:fr22de08-89]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2004-D-0298] (formerly Docket No. 2004D-0499)

Compliance Policy Guide; Radiofrequency Identification
Feasibility Studies and Pilot Programs for Drugs; Notice to Extend
Expiration Date

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice; extension of expiration date.

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SUMMARY: The Food and Drug Administration (FDA) is extending the
expiration date of compliance policy guide (CPG) Sec. 400.210 entitled
``Radiofrequency Identification (RFID) Feasibility Studies and Pilot
Programs for Drugs'' to December 31, 2010.

FOR FURTHER INFORMATION CONTACT: Ilisa Bernstein, Office of the
Commissioner, Office of Policy, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 1, rm. 4341, Silver Spring, MD 20993-0002, 301-
796-4830.

SUPPLEMENTARY INFORMATION: In the Federal Register of November 17, 2004
(69 FR 67360), FDA announced the availability of CPG Sec. 400.210
entitled ``Radiofrequency Identification (RFID) Feasibility Studies and
Pilot Programs for Drugs.'' FDA has identified RFID as a promising
technology to be used in the various efforts to combat counterfeit
drugs. The CPG describes how the agency intends to exercise its
enforcement discretion regarding certain regulatory requirements that
might otherwise be applicable to studies involving RFID technology for
drugs. The goal of the CPG is to facilitate performance of RFID studies
and to allow industry to gain experience with the use of RFID
technology and its effect on the long-term safety and integrity of the
U.S. drug supply.
    On September 27, 2007, the Food and Drug Administration Amendments
Act of 2007 (FDAAA) was signed into law. Section 913 of FDAAA addresses
pharmaceutical safety and creates section 505D of the Federal Food,
Drug, and Cosmetic Act (the act). Section 505D(b) of the act requires
the development of standards for the identification, validation,
authentication, and tracking and tracing of prescription drugs. Section
505D(b)(3) of the act states that these new standards shall address
promising technologies, which may include RFID technology.
    In implementing section 505D of the act, FDA is currently
addressing issues, such as promising technologies, that are relevant
also for the CPG. In addition, FDA is considering further the
experience of stakeholders and the agency under the CPG. As we consider
all of these issues, the CPG will remain in effect until December 31,
2010.

    Dated: December 16, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-30297 Filed 12-19-08; 8:45 am]

BILLING CODE 4160-01-S