Animal and Plant Health Inspection Service
Farm Service Agency
Food Safety and Inspection Service
Forest Service
National Foundation on the Arts and the Humanities
Economic Analysis Bureau
Foreign-Trade Zones Board
International Trade Administration
National Oceanic and Atmospheric Administration
Federal Energy Regulatory Commission
Presidential Documents
Centers for Disease Control and Prevention
Centers for Medicare & Medicaid Services
Food and Drug Administration
Inspector General Office, Health and Human Services Department
National Institutes of Health
Substance Abuse and Mental Health Services Administration
Coast Guard
Fish and Wildlife Service
Surface Mining Reclamation and Enforcement Office
Drug Enforcement Administration
Employee Benefits Security Administration
Employment and Training Administration
Federal Aviation Administration
Federal Railroad Administration
Federal Transit Administration
Maritime Administration
Surface Transportation Board
Internal Revenue Service
Consult the Reader Aids section at the end of this page for phone numbers, online resources, finding aids, reminders, and notice of recently enacted public laws.
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Federal Aviation Administration, DOT.
Final rule; technical amendment.
The FAA is correcting a final rule published on August 21, 2009 (74 FR 42500). In that rule, the FAA amended its regulations to revise the training, qualification, certification, and operating requirements for pilots, flight instructors, ground instructors, and pilot schools. This document reinstates two paragraphs that were inadvertently removed in one section, and amends an out-of-date cross reference in another section.
Effective April 7, 2011.
For technical questions concerning this action, contact Jeffrey Smith, Airmen Certification and Training Branch, AFS-810, General Aviation and Commercial Division, Flight Standards Service, Federal Aviation Administration, 800 Independence Avenue, SW., Washington, DC 20591; telephone (202) 493-4789; e-mail to
On August 21, 2009, the FAA published a final rule entitled, “Pilot, Flight Instructor, and Pilot School Certification; Final Rule” (74 FR 42500). That final rule revised the training, qualification, certification, and operating requirements for pilots, flight instructors, ground instructors, and pilot schools. The FAA is now issuing a technical amendment to § 61.57 to reinsert paragraphs (d)(1) and (d)(2) because those paragraphs were inadvertently removed from the final rule. The FAA is also amending an incorrect reference in § 61.65(c).
Section 61.57(d) establishes the requirements for an instrument proficiency check. Prior to issuance of the 2009 final rule, § 61.57(d) contained introductory text as well as paragraph (d)(1), which set forth the aircraft in which an instrument proficiency check must be performed, and paragraph (d)(2), which set forth those persons who are authorized to conduct an instrument proficiency check. In the 2009 final rule, the FAA stated in the amendatory instructions to § 61.57(d) that it was amending paragraph (d) rather than the introductory text to paragraph (d). As a result, paragraphs (d)(1) and (d)(2) were unintentionally removed from the final rule. The FAA is issuing this technical amendment to restore paragraphs (d)(1) and (d)(2) to § 61.57.
The FAA is also correcting a minor error to a reference in paragraph (c) of § 61.65. In the 2009 final rule, the FAA added paragraphs (e) and (f) to this section. A corresponding change to a cross reference in paragraph (c) that would have accounted for these additions was unintentionally omitted. This technical edit will correct that omission.
Because the changes in this technical amendment result in no substantive change, we find good cause exists under 5 U.S.C. 553(d)(3) to make the amendment effective in less than 30 days.
Aircraft, Airmen, Aviation safety.
In consideration of the foregoing, the Federal Aviation Administration amends chapter I of title 14, Code of Federal Regulations as follows:
49 U.S.C. 106(g), 40113, 44701-44703, 44707, 44709-44711, 45102-45103, 45301-45302.
(d) * * *
(1) The instrument proficiency check must be—
(i) In an aircraft that is appropriate to the aircraft category;
(ii) For other than a glider, in a flight simulator or flight training device that is representative of the aircraft category; or
(iii) For a glider, in a single-engine airplane or a glider.
(2) The instrument proficiency check must be given by—
(i) An examiner;
(ii) A person authorized by the U.S. Armed Forces to conduct instrument flight tests, provided the person being tested is a member of the U.S. Armed Forces;
(iii) A company check pilot who is authorized to conduct instrument flight tests under part 121, 125, or 135 of this chapter or subpart K of part 91 of this chapter, and provided that both the check pilot and the pilot being tested are employees of that operator or fractional ownership program manager, as applicable;
(iv) An authorized instructor; or
(v) A person approved by the Administrator to conduct instrument practical tests.
(c)
Internal Revenue Service (IRS), Treasury.
Final regulations and removal of temporary regulations.
This document contains final regulations that provide guidance relating to the reduction of the number of separate foreign tax credit limitation categories under section 904(d) of the Internal Revenue Code. Changes to the applicable law were made by the American Jobs Creation Act of 2004 (AJCA) reducing the number of section 904(d) separate categories from eight to two, effective for taxable years beginning after December 31, 2006. The final regulations provide guidance needed to comply with these changes and affect individuals and corporations claiming foreign tax credits.
Jeffrey L. Parry, (202) 622-3850 (not a toll-free number).
On December 21, 2007, a notice of proposed rulemaking by cross-reference to temporary regulations (REG-114126-07) under section 904 of the Code and temporary regulations (TD 9368) (the 2007 temporary regulations) were published in the
Section 954(c)(4), which was enacted by the AJCA, provides a look-through rule for sales of 25-percent-owned partnerships. Because the definition of passive income in section 904(d)(2)(B) refers to section 954(c), § 1.904-5T(h)(3)(ii) of the 2007 temporary regulations provides that in the case of a sale of a partnership interest by a 25-percent partner, under the principles of section 954(c)(4)(B) the income recognized on such sale is assigned to the separate category for general category income, to the extent that the gain would not be classified as foreign personal holding company income under the section 954(c)(4) look-through rule. The rule has been revised to clarify that the look-through rule applies to a sale by any 25-percent owner of a partnership (and not just controlled foreign corporations that are 25-percent partners). The language of this provision has also been revised to be more consistent with the language of the look-through rule as provided under section 954(c)(4).
Section 1.904(f)-12T(h) of the 2007 temporary regulations provides transition rules for recapture in a taxable year beginning after December 31, 2006 (post-2006 taxable year) of an overall foreign loss (OFL) or separate limitation loss (SLL) in a pre-2007 separate category (as defined in § 1.904-7T(g)(ii)) that offset U.S. source income or income in another pre-2007 separate category, respectively. Section 1.904(f)-12T(h)(3) provides that to the extent a taxpayer had an OFL or SLL at the end of the taxpayer's last pre-2007 taxable year in the pre-2007 separate category for high withholding tax interest, the allocation of such OFL or SLL to the taxpayer's post-2006 separate categories follows the taxpayer's allocation of excess taxes in the high withholding tax interest loss category for section 904(c) carryover purposes. If there were no excess taxes in the loss category that carried over to post-2006 taxable years, an OFL or SLL in the pre-2007 separate category for high withholding tax interest is allocated to the post-2006 separate category for passive category income. Similarly, § 1.904(f)-12T(h)(3) provides that where a taxpayer had an SLL in a pre-2007 separate category that offset high withholding tax interest (that is, an SLL with respect to a pre-2007 separate category for high withholding tax interest), the SLL will be recaptured in subsequent taxable years pro rata as income in the post-2006 separate categories for general category income and passive category income based on how the taxpayer allocated excess taxes in the pre-2007 separate category for high withholding tax interest. If no excess taxes in the pre-2007 separate category for high withholding tax interest were carried over to post-2006 taxable years, the SLL will be recaptured in subsequent taxable years as income in the post-2006 separate category for passive category income.
A question was raised as to whether it was appropriate, in the case of a financial services entity that had a loss in, or a loss with respect to, a pre-2007 separate category for high withholding tax interest, and no excess taxes in the loss category were carried over to post-2006 taxable years, that the loss be allocated to the post-2006 separate category for passive category income (in the case of a loss in the pre-2007 separate category for high withholding tax interest) or that the loss be recaptured in subsequent taxable years as income in the post-2006 separate category for passive category income (in the case of a loss with respect to a pre-2007 separate category for high withholding tax interest).
Section 904(d)(2)(C)(i), as amended by the AJCA, provides that financial services income is treated as general category income in the case of a member of a financial services group and any other person predominantly engaged in the active conduct of a banking, insurance, financing or similar business (a financial services entity). Financial services income includes passive income that is received or accrued by any person predominantly engaged in the active conduct of a banking, insurance, financing, or similar business, but does not include specified passive category income. See section 904(d)(2)(D)(i)(II). Accordingly, in post-2006 taxable years, income that otherwise would be treated as passive income (and assigned to the separate category for passive category income) will instead be treated as general category income in the case of a financial services entity.
The IRS and the Treasury Department believe that, in the case of a financial
Section 1.904-7(g)(3) of the final regulations clarifies that section 952(c)(2) recapture accounts maintained by a controlled foreign corporation with respect to subpart F income in a separate category that was subject to the earnings and profits limitation of section 952(c)(1)(A) are allocated to separate categories in the same manner as the associated post-1986 undistributed earnings.
The 2007 temporary regulations provide several safe harbors that a taxpayer may apply in lieu of generally applicable rules. Section 1.904-2T(i)(1)(ii) provides a safe harbor for the carryover of unused foreign taxes in a pre-2007 separate category to a post-2006 separate category; § 1.904-2T(i)(2)(ii) provides a safe harbor for the carryback of unused foreign taxes in a post-2006 separate category to a pre-2007 separate category; § 1.904-7T(g)(3)(ii) provides safe harbors for allocating pools of post-1986 undistributed earnings and post-1986 foreign income taxes in the pre-2007 separate categories of controlled foreign corporations and noncontrolled section 902 corporations to the post-2006 separate categories; and § 1.904(f)-12T(h)(5) provides an alternative method for determining the recapture in post-2006 taxable years of separate limitation losses and overall foreign losses incurred in pre-2007 taxable years.
A question was raised as to how a safe harbor method election is to be made and the time frame for making the election. The final regulations provide that taxpayers may choose to use a safe harbor method on a timely filed (original or amended) tax return or during audit. If a taxpayer chooses to use the safe harbor method on an amended return or in the course of an audit, the taxpayer must make appropriate adjustments to eliminate any double benefit arising from application of the safe harbor method to years that are not open for assessment. A taxpayer's choice to use the safe harbor method is evidenced by simply employing the method in determining its foreign tax credit limitation. No separate statement need be filed.
The effective/applicability dates are the same as those in the proposed and temporary regulations with minor clarifying changes.
It has been determined that this notice of proposed rulemaking is not a significant regulatory action as defined in Executive Order 12866. Therefore, a regulatory assessment is not required. It has also been determined that section 553(b) of the Administrative Procedure Act (5 U.S.C. chapter 5) does not apply to these regulations, and because the regulations do not impose a collection of information on small entities, the Regulatory Flexibility Act (5 U.S.C. chapter 6) does not apply.
The principal author of these regulations is Jeffrey L. Parry of the Office of Chief Counsel (International). However, other personnel from the Treasury Department and the IRS participated in their development.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is amended as follows:
26 U.S.C. 7805 * * *
(i) Transition rules for carryovers and carrybacks of pre-2007 and post-2006 unused foreign tax.
(1) Carryover of unused foreign tax.
(i) General rule.
(ii) Safe harbor.
(2) Carryback of unused foreign tax.
(i) General rule.
(ii) Safe harbor.
(3) Effective/applicability date.
(a) In general.
(b) Passive category income.
(1) In general.
(2) Passive income.
(i) In general.
(ii) Exceptions.
(iii) Active rents or royalties.
(A) In general.
(B) Active conduct of trade or business.
(iv) Examples.
(3) Specified passive category income.
(h) * * *
(3) Exception.
(l) Priority rule.
(h) * * *
(3) Income from the sale of a partnership interest.
(i) In general.
(ii) Exception for sale by 25-percent owner.
(o) * * *
(3) Rules for income from the sale of a partnership interest.
(g) Treatment of earnings and foreign taxes of a controlled foreign corporation or a noncontrolled section 902 corporation accumulated in taxable years beginning before January 1, 2007.
(1) Definitions.
(i) Pre-2007 pools.
(ii) Pre-2007 separate categories.
(iii) Post-2006 separate categories.
(2) Treatment of pre-2007 pools of a controlled foreign corporation or a noncontrolled section 902 corporation.
(3) Substantiation of post-2006 character of earnings and taxes in a pre-2007 pool.
(i) Reconstruction of earnings and taxes pools.
(ii) Safe harbor method.
(A) In general.
(B) General safe harbor method.
(C) Interest apportionment safe harbor.
(iii) Consistency rule.
(4) Treatment of pre-1987 accumulated profits.
(5) Treatment of earnings and foreign taxes in pre-2007 pools of a lower-tier controlled foreign corporation or noncontrolled section 902 corporation.
(6) Effective/applicability date.
(i)
(ii)
(2)
(ii)
(3)
(a)
(b)
(2)
(A) Income received or accrued by any person that is of a kind that would be foreign personal holding company income (as defined in section 954(c)) if the taxpayer were a controlled foreign corporation, including any amount of gain on the sale or exchange of stock in excess of the amount treated as a dividend under section 1248; or
(B) Amount includible in gross income under section 1293.
(ii)
(iii)
(B)
(iv)
P is a domestic corporation with a branch in foreign country X. P does not have any financial services income. For 2008, P has a net foreign currency gain that would not constitute foreign personal holding company income if P were a controlled foreign corporation because the gain is directly related to the business needs of P. The currency gain is, therefore, general category income to P because it is not income of a kind that would be foreign personal holding company income.
Controlled foreign corporation S is a wholly-owned subsidiary of P, a domestic corporation. S is regularly engaged in the restaurant franchise business. P licenses trademarks, tradenames, certain know-how, related services, and certain restaurant designs for which S pays P an arm's length royalty. P is regularly engaged in the development and licensing of such property. The royalties received by P for the use of its property are allocable under the look-through rules of § 1.904-5 to the royalties S receives from the franchisees. Some of the franchisees are unrelated to S and P. Other franchisees are related to S or P and use the licensed property outside of S's country of incorporation. S does not satisfy, but P does satisfy, the active trade or business requirements of section 954(c)(2)(A) and the regulations under that section. The royalty income earned by S with regard to both its related and unrelated franchisees is foreign personal holding company income because S does not satisfy the active trade or business requirements of section 954(c)(2)(A) and, in addition, the royalty income from the related franchisees does not qualify for the same country exception of section 954(c)(3). However, all of the royalty income earned by S is general category income to S under § 1.904-4(b)(2)(iii) because P, a member of S's affiliated group (as defined therein), satisfies the active trade or business test (which is applied without regard to whether the royalties are paid by a related person). S's royalty income that is taxable to P under subpart F and the royalties paid to P are general category income to P under the look-through rules of § 1.904-5(c)(1)(i) and (c)(3), respectively.
(3)
(i) Dividends from a DISC or former DISC (as defined in section 992(a)) to the extent such dividends are treated as income from sources without the United States;
(ii) Taxable income attributable to foreign trade income (within the meaning of section 923(b)); or
(iii) Distributions from a FSC (or a former FSC) out of earnings and profits attributable to foreign trade income (within the meaning of section 923(b)) or interest or carrying charges (as defined in section 927(d)(1)) derived from a transaction which results in foreign trade income (as defined in section 923(b)).
(f) [Reserved].
(g) [Reserved].
(h) * * *
(3)
(i) Income received or accrued by a controlled foreign corporation that is income described in section 864(d)(6) (income of a controlled foreign corporation from a loan for the purpose of financing the purchase of inventory property of a related person); or
(ii) Income received or accrued by any person that is income described in section 864(d)(1) (income from a trade receivable acquired from a related person).
(l)
(n) * * * Paragraphs (a), (b), (h)(3), and (l) of this section shall apply to taxable years of United States persons and, for purposes of section 906, foreign persons beginning after December 31, 2006 and ending on or after December 21, 2007, and to taxable years of a foreign corporation which end with or within taxable years of its domestic corporate shareholder beginning after December 31, 2006 and ending on or after December 21, 2007. * * *
(h) * * *
(3)
(ii)
(o) * * *
(3)
(g)
(ii)
(iii)
(2)
(3)
(ii)
(B)
(
(
(
(C)
(iii)
(4)
(5)
(6)
(h) Recapture in years beginning after December 31, 2006, of separate limitation losses and overall foreign losses incurred in years beginning before January 1, 2007.
(1) Losses related to pre-2007 separate categories for passive income, certain dividends from a DISC or former DISC, taxable income attributable to certain foreign trade income or certain distributions from a FSC or former FSC.
(i) Recapture of separate limitation loss or overall foreign loss incurred in a pre-2007 separate category for passive income, certain dividends from a DISC or former DISC, taxable income attributable to certain foreign trade income or certain distributions from a FSC or former FSC.
(ii) Recapture of separate limitation loss with respect to a pre-2007 separate category for passive income, certain dividends from a DISC or former DISC, taxable income attributable to certain foreign trade income or certain distributions from a FSC or former FSC.
(2) Losses related to pre-2007 separate categories for shipping, financial services income or general limitation income.
(i) Recapture of separate limitation loss or overall foreign loss incurred in a pre-2007 separate category for shipping income, financial services income or general limitation income.
(ii) Recapture of separate limitation loss with respect to a pre-2007 separate category for shipping income, financial services income or general limitation income.
(3) Losses related to a pre-2007 separate category for high withholding tax interest.
(i) Recapture of separate limitation loss or overall foreign loss incurred in a pre-2007 separate category for high withholding tax interest.
(ii) Recapture of separate limitation loss with respect to a pre-2007 separate category for high withholding tax interest.
(4) Elimination of certain separate limitation loss accounts.
(5) Alternative method.
(6) Effective/applicability date.
(h)
(ii)
(2)
(ii)
(3)
(ii)
(4)
(5)
(6)
Coast Guard, DHS.
Rule; information collection approval.
On December 14, 2010, the Coast Guard amended its regulations governing the maximum weight and number of passengers that may safely be permitted on board a vessel and other stability regulations, including increasing the Assumed Average Weight per Person (AAWPP) to 185 lb. The amendment triggered new information collection requirements affecting documentation needed from certain inspected vessels as part of the Coast Guard commercial vessel safety program. This document announces that the Office of Management and Budget (OMB) approved changes to the collections of information with control numbers 1625-0057 and 1625-0064, which will now be enforced.
Changes to the collection of information requirements with OMB control numbers 1625-0057 and 1625-0064 will be enforced under 46 CFR parts 115, 170, 176, and 178 beginning April 7, 2011.
If you have questions about this document, contact Mr. William Peters at 202-372-1371 or
With the exception of revised collection of information provisions, the Passenger Weight and Inspected Vessel Stability Requirements rule became effective on March 14, 2011. Under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520), an agency may not conduct or sponsor a collection of information until the collection is approved by OMB. Accordingly, the preamble to the final rule stated that the Coast Guard would not enforce the new collection of information requirements in 46 CFR parts 115, 170, 176, and 178 until the collection of information requests were approved by OMB, and also stated that the Coast Guard would publish a notice in the
The Coast Guard submitted the information collection requests to OMB for approval in accordance with the Paperwork Reduction Act of 1995. OMB approved the collections of information on March 4, 2011, for 1625-0064, and on March 14, 2011, for 1625-0057. The approval for these collections of information expires on March 31, 2014. Copies of the OMB notices of action are available in our online docket (USCG-2007-0030) at
Federal Communications Commission.
Final rule.
The Commission grants a petition for rulemaking issued in response to a petition for rulemaking filed by George S. Flinn, Jr. (“Flinn”), the licensee of WWJX, channel 51, Jackson, Mississippi, requesting the substitution of channel 23 for channel 51 at Jackson. Flinn raises concerns regarding potential interference that may occur to Long Term Evolution cellular base stations operating on adjacent channel spectrum and believes substituting channel 23 for channel 51 will better serve the public interest.
This rule is effective May 9, 2011.
Joyce L. Bernstein, joyce.bernstein@fcc.gov, Media Bureau, (202) 418-1600.
This is a synopsis of the Commission's
This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
The Commission will send a copy of this
Television.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:
47 U.S.C. 154, 303, 334, 336, and 339.
Federal Communications Commission.
Final rule.
The Commission grants a petition for rulemaking issued in response to a petition for rulemaking filed by Comcorp of El Paso License Corp. (“Comcorp”), the licensee of KTSM-TV, channel 9, El Paso, Texas, requesting the substitution of channel 16 for channel 9 at El Paso. Comcorp states that this channel substitution is necessary because KTSM-TV has experienced significant technical difficulties since the station terminated its analog service and transitioned to post-transition channel 9 and believes channel 16 will allow better broadcast service to the public.
This rule is effective May 9, 2011.
Adrienne Y. Denysyk,
This is a synopsis of the Commission's
This document does not contain information collection requirements subject to the Paperwork Reduction Act of 1995, Public Law 104-13. In addition, therefore, it does not contain any information collection burden “for small business concerns with fewer than 25 employees,” pursuant to the Small Business Paperwork Relief Act of 2002, Public Law 107-198,
The Commission will send a copy of this
Television.
For the reasons discussed in the preamble, the Federal Communications Commission amends 47 CFR part 73 as follows:
47 U.S.C. 154, 303, 334, 336, and 339.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Temporary rule; quota transfer.
NMFS announces that the State of North Carolina is transferring a portion of its 2011 commercial summer flounder quota to the Commonwealth of
Effective April 4, 2011 through December 31, 2011.
Carly Knoell, Fishery Management Specialist, 978-281-9224.
Regulations governing the summer flounder fishery are found at 50 CFR part 648. The regulations require annual specification of a commercial quota that is apportioned among the coastal states from North Carolina through Maine. The process to set the annual commercial quota and the percent allocated to each state are described in § 648.100.
The final rule implementing Amendment 5 to the Summer Flounder, Scup, and Black Sea Bass Fishery Management Plan, which was published on December 17, 1993 (58 FR 65936), provided a mechanism for summer flounder quota to be transferred from one state to another. Two or more states, under mutual agreement and with the concurrence of the Administrator, Northeast Region, NMFS (Regional Administrator), can transfer or combine summer flounder commercial quota under § 648.100(d). The Regional Administrator is required to consider the criteria set forth in § 648.100(d)(3) in the evaluation of requests for quota transfers or combinations.
North Carolina has agreed to transfer 499,411 lb (226,529 kg) of its 2011 commercial quota to Virginia. This transfer was prompted by 57 summer flounder landings of North Carolina vessels that were granted safe harbor in Virginia due to hazardous shoaling in Oregon Inlet, North Carolina, severe winter storm conditions, and/or mechanical problems between March 7, 2011, and March 17, 2011. The Regional Administrator has determined that the criteria set forth in § 648.100(d)(3) have been met. The revised summer flounder quotas for calendar year 2011 are: North Carolina, 4,163,328 lb (1,888,454 kg); and Virginia, 4,309,240 lb (1,954,639 kg).
This action is taken under 50 CFR part 648 and is exempt from review under Executive Order 12866.
16 U.S.C. 1801
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
We propose to supersede an existing airworthiness directive (AD) that applies to the products listed above. The existing AD currently requires an inspection of the No. 2 and No. 3 windows on the left and right sides of the airplane to determine their part numbers, related investigative and corrective actions if necessary, and repetitive inspections of single pane windows. Since we issued that AD, we have determined that terminating action for the repetitive inspections is necessary. This proposed AD would add a requirement to install dual pane No. 2 and No. 3 windows. This proposed AD also removes certain airplanes from the applicability. We are proposing this AD to detect and correct cracking in the fail-safe interlayer of certain No. 2 and No. 3 glass windows, which could result in loss of the window and consequent rapid loss of cabin pressure. Loss of the window could also result in crew communication difficulties or incapacitation of the crew.
We must receive comments on this proposed AD by May 23, 2011.
You may send comments by any of the following methods:
•
•
•
•
For service information identified in this AD, contact Boeing Commercial Airplanes, Attention: Data & Services Management, P.O. Box 3707, MC 2H-65, Seattle, Washington 98124-2207; phone: 206-544-5000, extension 1; fax: 206-766-5680; e-mail:
You may examine the AD docket on the Internet at
Steven Fox, Senior Aerospace Engineer, Airframe Branch, ANM-120S, Seattle Aircraft Certification Office (ACO), FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; phone: 425-917-6425; fax: 425-917-6590; e-mail:
We invite you to send any written relevant data, views, or arguments about this proposed AD. Send your comments to an address listed under the
We will post all comments we receive, without change, to
On July 18, 2007, we issued AD 2007-15-10, Amendment 39-15139 (72 FR 41438, July 30, 2007), for all Boeing Model 747 airplanes. A correction of that AD was published in the
The preamble of the original NPRM for AD 2007-15-10 (Docket Number FAA-2006-26441, Directorate Identifier 2006-NM-204-AD) specifies that we consider the actions an “interim action until final action is identified, at which time we may consider further rulemaking”. We have determined that further rulemaking is indeed necessary; this proposed AD follows from that determination.
AD 2007-15-10 cited Boeing Alert Service Bulletin 747-56A2012, dated August 24, 2006, as the relevant source of service information. Since we issued AD 2007-15-10, Boeing has issued Service Bulletin 747-56A2012, Revision 1, dated August 12, 2010. Boeing Service Bulletin 747-56A2012, Revision
We are proposing this AD because we evaluated all the relevant information and determined the unsafe condition described previously is likely to exist or develop in other products of the same type design.
This proposed AD would retain certain requirements of AD 2007-15-10. This proposed AD would also require accomplishing the actions specified in Boeing Service Bulletin 747-56A2012, Revision 1, dated August 12, 2010, except as discussed under “Differences Between the Proposed AD and the Service Information.” This proposed AD also removes airplanes having line numbers 1418 and on from the applicability.
This AD proposes to prohibit installed dual structural glass pane windows from being replaced with single structural glass pane windows. This proposed AD would also add a definition of “non-clear damage”, which the Accomplishment Instructions of Boeing Service Bulletin 747-56A2012, Revision 1, dated August 12, 2010, use as criteria for window replacement.
We estimate that this proposed AD affects 144 airplanes of U.S. registry.
We estimate the following costs to comply with this proposed AD:
We estimate the following costs to do any necessary replacements that would be required based on the results of the proposed inspection. We have no way of determining the number of aircraft that might need these replacements:
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.
We have determined that this proposed AD would not have federalism implications under Executive Order 13132. This proposed AD would 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 above, I certify that the proposed regulation:
(1) Is not a “significant regulatory action” under Executive Order 12866,
(2) Is not a “significant rule” under the DOT Regulatory Policies and Procedures (44 FR 11034, February 26, 1979),
(3) Will not affect intrastate aviation in Alaska, 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.
Air transportation, Aircraft, Aviation safety, Incorporation by reference, Safety.
Accordingly, under the authority delegated to me by the Administrator, the FAA proposes to amend 14 CFR part 39 as follows:
1. The authority citation for part 39 continues to read as follows:
49 U.S.C. 106(g), 40113, 44701.
2. The FAA amends § 39.13 by removing airworthiness directive (AD) 2007-15-10, Amendment 39-15139 (72 FR 41438, July 30, 2007), corrected at 72 FR 53923, September 21, 2007, and adding the following new AD:
(a) The FAA must receive comments on this AD action by May 23, 2011.
(b) This AD supersedes AD 2007-15-10, Amendment 39-15139.
(c) This AD applies to The Boeing Company Model 747-100, 747-100B, 747-100B SUD, 747-200B, 747-200C, 747-200F, 747-300, 747-400, 747-400D, 747-400F, 747SR, and 747SP Series Airplanes, certificated in any category, as identified in Boeing Service Bulletin 747-56A2012, Revision 1, dated August 12, 2010.
(d) Joint Aircraft System Component (JASC)/Air Transport Association (ATA) of America Code 56, Windows.
(e) This AD was prompted by loss of a No. 3 window in-flight. We are issuing this AD to detect and correct cracking in the fail-safe interlayer of certain No. 2 and No. 3 glass windows, which could result in loss of the window and consequent rapid loss of cabin pressure. Loss of the window could also result in crew communication difficulties or incapacitation of the crew.
(f) Comply with this AD within the compliance times specified, unless already done.
(g) Inspect the No. 2 and No. 3 windows on the left and right sides of the airplane to determine their part numbers, and do all the applicable related investigative and corrective actions, by accomplishing all of the actions specified in the Accomplishment Instructions of Boeing Alert Service Bulletin 747-56A2012, dated August 24, 2006; or Boeing Service Bulletin 747-56A2012, Revision 1, dated August 12, 2010; except as required by paragraph (j) of this AD; as applicable. Do all of these actions at the compliance times specified in Tables 1, 2, and 3 of paragraph 1.E. of Boeing Alert Service Bulletin 747-56A2012, dated August 24, 2006, as applicable, except as provided by paragraph (h) of this AD. A review of airplane maintenance records is acceptable in lieu of the inspection if the part numbers of the windows can be conclusively determined from that review. Repeat the related investigative and corrective actions thereafter at the interval specified in Table 2 or 3 of paragraph 1.E. of Boeing Alert Service Bulletin 747-56A2012, dated August 24, 2006, as applicable. As of the effective date of this AD, do the actions specified in this paragraph, in accordance with the Accomplishment Instructions of Boeing Service Bulletin 747-56A2012, Revision 1, dated August 12, 2010, except as required by (j) of this AD. Replacing a window in accordance with paragraph (i) of this AD terminates the requirements of this paragraph for that window.
(h) Where Tables 1, 2, and 3 of paragraph 1.E. of Boeing Alert Service Bulletin 747-56A2012, dated August 24, 2006, specify counting the compliance time from “* * * after the date on this service bulletin,” this AD requires counting the compliance time from September 4, 2007 (the effective date of AD 2007-15-10). After replacing a discrepant window with a new window, having part number (P/N) 65B27042-(), 65B27043-(), 65B27046-(), or 65B27047-(), do the initial detailed inspection of the new window at the applicable compliance time: (1) Within 5,500 flight hours after installing P/N 65B27042-() or 65B27043-(), or (2) Within 22,000 flight hours after installing P/N 65B27046-() or 65B27047-().
(i) Within 6 years after the effective date of this AD, replace all No. 2 windows having P/N 65B27042-() or 65B27046-(), with windows having P/N 141U4821-() or 141U4822-(), and replace all No. 3 windows having P/N 65B27043-() or 65B27047-() with windows having P/N 141U4831-() or 141U4832-(), in accordance with Part 3—Window Replacement of the Accomplishment Instructions of Boeing Service Bulletin 747-56A2012, Revision 1, dated August 12, 2010. Doing this replacement for all windows terminates the actions required by paragraphs (g) and (h) of this AD.
(j) Where Step 4.e. of Part 2 of the Work Instructions of Boeing Service Bulletin 747-56A2012, Revision 1, dated August 12, 2010, specifies “non-clear damage” as a criteria for window replacement, this AD defines non-clear damage to be any degradation of the transparency of the window, which would hinder the internal or external detailed inspections for fail-safe interlayer cracks, glass pane cracks and chips, and indications of arcing. Replacement for non-clear damage is required by this AD only if the non-clear damage hinders the inspection for fail-safe interlayer cracks, glass pane cracks and chips, or indications of arcing.
(k) As of the effective date of this AD, do not install any No. 2 or No. 3 window having P/N 65B27042-(), 65B27043-(), 65B27046-(), or 65B27047-() that is not new or on which the window flight hours are not known, on any airplanes, unless the actions specified in paragraph (g) of this AD are done.
(l)(1) The Manager, Seattle Aircraft Certification Office, FAA, has the authority to approve AMOCs for this AD, if requested using the procedures found in 14 CFR 39.19. In accordance with 14 CFR 39.19, send your request to your principal inspector or local Flight Standards District Office, as appropriate. If sending information directly to the manager of the ACO, send it to the attention of the person identified in the Related Information section of this AD. Information may be e-mailed to:
(2) Before using any approved AMOC, notify your appropriate principal inspector, or lacking a principal inspector, the manager of the local flight standards district office/certificate holding district office.
(3) An AMOC that provides an acceptable level of safety may be used for any repair required by this AD if it is approved by the Boeing Commercial Airplanes Organization Designation Authorization (ODA) that has been authorized by the Manager, Seattle ACO to make those findings. For a repair method to be approved, the repair must meet the certification basis of the airplane and the approval must specifically refer to this AD.
(4) AMOCs previously approved in accordance with AD 2007-15-10, Amendment 39-15139, are approved as AMOCs for the corresponding provisions of this AD except previous AMOCs approving window replacement that do not specify installing dual structural glass pane windows are not considered approved for corresponding inspection methods required by this AD.
(m) For more information about this AD, contact Steven Fox, Senior Aerospace Engineer, Airframe Branch, ANM120S, Seattle Aircraft Certification Office (ACO), FAA, 1601 Lind Avenue, SW., Renton, Washington 98057-3356; phone: 425-917-6425; fax: 425-917-6590; e-mail:
Federal Aviation Administration (FAA), DOT.
Notice of proposed rulemaking (NPRM).
This action proposes to modify Class E airspace at Gallatin Field Airport, Bozeman, MT, to accommodate aircraft using Instrument Landing System (ILS) Localizer (LOC) standard instrument approach procedures at the airport. The FAA is proposing this action to enhance the safety and management of aircraft operations at the airport. This action also would adjust the geographic coordinates of the airport for the Class D and E airspace areas, and would update the airport name.
Comments must be received on or before May 23, 2011.
Send comments on this proposal 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; telephone (202) 366-9826. You must identify FAA Docket No. FAA-2011-0249; Airspace Docket No. 11-ANM-6, at the beginning of your comments. You may also submit comments through the Internet at
Eldon Taylor, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue, SW., Renton, WA 98057; telephone (425) 203-4537.
Interested parties are invited to participate in this proposed rulemaking by submitting such written data, views, or arguments, as they may desire. Comments that provide the factual basis supporting the views and suggestions presented are particularly helpful in developing reasoned regulatory decisions on the proposal. Comments are specifically invited on the overall regulatory, aeronautical, economic, environmental, and energy-related aspects of the proposal.
Communications should identify both docket numbers (FAA Docket No. FAA 2011-0249 and Airspace Docket No. 11-ANM-6) and be submitted in triplicate to the Docket Management System (
Commenters wishing the FAA to acknowledge receipt of their comments on this action must submit with those comments a self-addressed stamped postcard on which the following statement is made: “Comments to FAA Docket No. FAA-2011-0249 and Airspace Docket No. 11-ANM-6”. The postcard will be date/time stamped and returned to the commenter.
All communications received on or before the specified closing date for comments will be considered before taking action on the proposed rule. The proposal contained in this action may be changed in light of comments received. All comments submitted will be available for examination in the public docket both before and after the closing date for comments. A report summarizing each substantive public contact with FAA personnel concerned with this rulemaking will be filed in the docket.
An electronic copy of this document may be downloaded through the Internet at
You may review the public docket containing the proposal, any comments received, and any final disposition in person in the Dockets Office (
Persons interested in being placed on a mailing list for future NPRMs should contact the FAA's Office of Rulemaking, (202) 267-9677, for a copy of Advisory Circular No. 11-2A, Notice of Proposed Rulemaking Distribution System, which describes the application procedure.
The FAA is proposing an amendment to Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace designated as an extension to Class D surface area at Gallatin Field Airport, Bozeman, MT. Controlled airspace is necessary to accommodate aircraft using the ILS LOC standard instrument approach procedures at the airport and would enhance the safety and management of aircraft operations. The geographic coordinates of the Gallatin Field Airport for Class D airspace, Class E surface area airspace, and Class E airspace extending upward from 700 feet above the surface, would be adjusted in accordance with the FAA's aeronautical database. This action would also update the airport name from Bozeman, Gallatin Field Airport, MT, to Gallatin Field Airport.
Class D and Class E airspace designations are published in paragraph 5000, 6002, 6004 and 6005, respectively, of FAA Order 7400.9U, dated August 18, 2010, and effective September 15, 2010, which is incorporated by reference in 14 CFR Part 71.1. The Class D and Class E airspace designation listed in this document will be published subsequently in this Order.
The FAA has determined this proposed regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this proposed regulation; (1) is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this proposed rule, when promulgated, would not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, section 106, describes the authority for the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in subtitle VII, part A, subpart I, section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of the airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it establishes additional controlled airspace at Gallatin Field Airport, Bozeman, MT.
Airspace, Incorporation by reference, Navigation (air).
Accordingly, pursuant to the authority delegated to me, the Federal Aviation Administration proposes to amend 14 CFR part 71 as follows:
1. The authority citation for 14 CFR part 71 continues to read as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
2. The incorporation by reference in 14 CFR Part 71.1 of the Federal Aviation Administration Order 7400.9U, Airspace Designations and Reporting Points, dated August 18, 2010, and effective September 15, 2010 is amended as follows:
That airspace extending upward from the surface to and including 7,000 feet MSL within a 4.4-mile radius of Gallatin Field Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
Within a 4.4-mile radius of Gallatin Field Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from the surface within 3 miles each side of the 316° bearing of Gallatin Field Airport extending from the 4.4-mile radius of the airport to 15.5 miles northwest of the airport, and that airspace 2.4 miles each side of the 212° bearing of the Gallatin Field Airport extending from the 4.4-mile radius of the airport to 7 miles southwest of the airport.
That airspace extending upward from 700 feet above the surface within a 13.5-mile radius of Gallatin Field Airport, and within 4.8 miles northeast and 13 miles southwest of the 316° bearing of the airport extending from the 13.5-mile radius to 24.4 miles northwest of Gallatin Field Airport.
Bureau of Economic Analysis, Commerce.
Notice of proposed rulemaking.
The Bureau of Economic Analysis (BEA) proposes to amend its regulations related to direct investment surveys. Specifically, BEA proposes to eliminate reporting requirements for several direct investment surveys that are no longer necessary because the information is collected on other surveys of direct investment conducted by BEA. The surveys that would be eliminated from the regulations are: a survey of foreign direct investment in the U.S. seafood industry (BE-21), two schedules of expenditures for property, plant, and equipment of U.S. direct investment abroad (BE-133B and BE-133C), and two industry classification questionnaires (BE-507 and BE-607). In addition, BEA proposes to eliminate the reporting requirements for two surveys of new foreign direct investment in the United States (BE-13 and BE-14). BEA suspended collection of these surveys in 2009 in order to align its international survey program with available resources. BEA also proposes other minor revisions to its regulations to eliminate outdated information.
Comments on this proposed rule will receive consideration if submitted in writing on or before June 6, 2011.
You may submit comments, identified by RIN 0691-AA78, and referencing the agency name (Bureau of Economic Analysis), by any of the following methods:
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Written comments regarding the burden-hour estimates or other aspects of the collection-of-information requirements contained in the proposed rule should be sent both to BEA, through any of the methods above, and to the Office of Management and Budget, O.I.R.A., Paperwork Reduction Project 0608-0024, 0608-0030, 0608-0032, 0608-0035, and 0608-0050, Attention PRA Desk Officer for BEA, via e-mail at
David H. Galler, Chief, Direct Investment Division (BE-50), Bureau of Economic Analysis, U.S. Department of Commerce, Washington, DC 20230; phone (202) 606-9835.
This proposed rule would amend 15 CFR part 806 by revising Sections 806.14, 806.15, and 806.18 to remove the reporting requirements for several direct investment surveys. The surveys are:
The Department of Commerce, as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to comment on the cancellation of the reporting requirements for these surveys, consistent with the Paperwork Reduction Act of 1995.
BEA is proposing to remove the reporting requirements for the BE-13 and the BE-14 surveys which were suspended in 2009 in order to align its international survey program with available resources. The surveys had been used to collect identification information on the U.S. business being established or acquired and on the new foreign owner, information on the cost of the investment and source of funding, and limited financial and operating data for the newly established or acquired entity. The data had been used to measure the amount of new foreign direct investment in the United States and assess its impact on the U.S. economy. BEA continues to identify newly acquired or established U.S. affiliates of foreign investors and bring them into its international survey program through the BE-12, BE-15, and BE-605 surveys, which are the benchmark, annual, and quarterly surveys of foreign direct investment in the United States, respectively, but they are not separately identified in BEA's published statistics.
BEA is proposing to eliminate the regulations for the BE-21, BE-133B, BE-133C, BE-507, and BE-607 surveys since they have not been conducted in many years and are no longer necessary because the information is collected on other surveys of direct investment conducted by BEA.
In addition, BEA proposes other minor revisions to its regulations to eliminate outdated information. These revisions eliminate references to outdated information regarding BE-10 survey forms and inactive OMB control numbers.
This proposed rule has been determined to be not significant for purposes of E.O. 12866.
This proposed rule does not contain policies with Federalism implications as that term is defined in E.O. 13132.
The Office of Management and Budget (OMB) approvals under the Paperwork Reduction Act for the seven surveys that BEA is proposing to eliminate have expired. The information collection approval for the BE-13 and BE-14 (under OMB control number 0608-0035) expired on August 31, 2009; the BE-21 approval (OMB control number 0608-0050) expired September 30, 1983; the BE-133B and BE-133C (OMB control number 0608-0024) expired December 31, 1994; the BE-507 approval (OMB control number 0608-0032) expired April 30, 1997; and the BE-607 approval (OMB control number 0608-0030) expired on May 31, 1991.
The Chief Counsel for Regulation, Department of Commerce, has certified to the Chief Counsel for Advocacy, Small Business Administration, under the provisions of the Regulatory Flexibility Act (5 U.S.C. 605(b)), that this proposed rulemaking, if adopted, will not have a significant economic impact on a substantial number of small entities. Entities that have foreign affiliates, that are at least ten percent foreign-owned, or that assisted or intervened in the acquisition of a U.S. business enterprise by a foreign person would have been subject to the reporting requirements that are proposed to be eliminated in this rulemaking. However, BEA does not currently collect data that enables BEA to determine how many of these entities would be considered “small” under the Small Business Administration's size standards. Although BEA does not know the number of small entities that would have been subject to the reporting requirements being eliminated by this rulemaking, BEA has determined that this action would not have a significant economic impact as this rule proposes to merely remove references to the surveys that are no longer in use. The collection of the BE-13 and BE-14 surveys was suspended in 2009, and the BE-21, BE-133B, BE-133C, BE-507, and BE-607 surveys have not been conducted in many years. In addition, the information collection approvals for these surveys have expired and are no longer part of the inventory of active collections of information maintained by the Office of Management and Budget. Because there would be no impact to small entities as a result of this change to the regulations, the Chief Counsel certified that this proposed rulemaking, if adopted, will not have a significant economic impact on a substantial number of small entities.
Economic statistics, Foreign investment in the United States, International transactions, Penalties, Reporting and recordkeeping requirements.
For reasons set forth in the preamble, BEA proposes to amend 15 CFR part 806 as follows:
1. The authority citation for 15 CFR part 806 continues to read as follows:
5 U.S.C. 301; 22 U.S.C. 3101-3108; E.O. 11961 (3 CFR, 1977 Comp., p. 86), as amended by E.O. 12318 (3 CFR, 1981 Comp., p. 173), and E.O. 12518 (3 CFR, 1985 Comp., p. 348).
2. Amend § 806.14 to revise paragraphs (d), (f) and (g) to read as follows:
(d)
(1) For quarterly report forms, as to the assets test reports are required beginning with the quarter in which total assets exceed the exemption level; as to the test for sales (revenues) and net income after income taxes, reports are required for each quarter of a year in which the annual amount of these items exceeds or can be expected to exceed, the exemption level. Quarterly reports for a year may be required retroactively when it is determined that the exemption level has been exceeded.
(2) For report forms requesting annual data after the close of the year in question, the test shall be whether any one of the three items exceeded the exemption level during that year.
If total assets, sales or net income exceed the exemption level in a given year, it is deemed that the exemption level will also be exceeded in the following year.
The number and title of each report form, its exemption level, and other reporting criteria, if any, pertaining to it, are given below.
(f)
(2) [Reserved.]
(3) BE-11—Annual Survey of U.S. Direct Investment Abroad: A report, consisting of Form BE-11A and Form(s) BE-11B, BE-11C, BE-11D and/or BE-11E, is required of each U.S. Reporter that, at the end of the Reporter's fiscal year, had a foreign affiliate reportable on Form BE-11B, BE-11C, BE-11D or BE-11E. Forms required and the criteria for reporting on each are as follows:
(i) Form BE-11A (Report for U.S. Reporter) must be filed by each U.S. person having a foreign affiliate reportable on Form BE-11B, BE-11C, BE-11D or BE-11E. If the U.S. Reporter is a corporation, Form BE-11A is required to cover the fully consolidated U.S. domestic business enterprise.
(A) If for a U.S. Reporter any one of the following three items—total assets, sales or gross operating revenues excluding sales taxes, or net income after provision for U.S. income taxes—was greater than $300 million (positive or negative) at the end of, or for, the Reporter's fiscal year, the U.S. Reporter must file a complete Form BE-11A. It must also file a Form BE-11B, BE-11C, BE-11D or BE-11E, as applicable, for each nonexempt foreign affiliate.
(B) If for a U.S. Reporter no one of the three items listed in paragraph (f)(3)(i)(A) of this section was greater than $300 million (positive or negative) at the end of, or for, the Reporter's fiscal year, the U.S. Reporter is required to file on Form BE-11A only items 1 through 26 and Part IV. It must also file a Form BE-11B, BE-11C, BE-11D, or BE-11E as applicable, for each nonexempt foreign affiliate.
(ii) Forms BE-11B, BE-11C, BE-11D, and BE-11E (Report for Foreign Affiliate).
(A) Form BE-11B must be reported for each majority-owned foreign affiliate, whether held directly or indirectly, for which any one of the following three items—total assets, sales or gross operating revenues excluding sales taxes, or net income after provision for foreign income taxes—was greater than $60 million (positive or negative) at the end of, or for, the affiliate's fiscal year, unless the foreign affiliate is selected to be reported on Form BE-11E.
(B) Form BE-11C must be reported for each minority-owned foreign affiliate, whether held directly or indirectly, for which any one of the three items listed in paragraph (f)(3)(ii)(A) of this section was greater than $60 million (positive or negative) at the end of, or for, the affiliate's fiscal year.
(C) Form BE-11D must be reported for each majority- and minority-owned foreign affiliate, whether held directly or indirectly, established or acquired during the year for which any one of the three items listed in paragraph (f)(3)(ii)(A) of this section was greater than $25 million (positive or negative), but for which no one of these items was greater than $60 million (positive or negative), at the end of, or for, the affiliate's fiscal year. Form BE-11D is a schedule; a U.S. Reporter would submit one or more pages of the form depending on the number of affiliates that are required to be filed on this form.
(D) Form BE-11E must be reported for each foreign affiliate that is selected by BEA to be reported on this form in lieu of Form BE-11B. BEA statistically divides into panels, affiliates for which any one of the three items listed in paragraph (f)(3)(ii)(A) of this section was greater than $60 million (positive or negative), but for which no one of these items was greater than $300 million (positive or negative), at the end of, or for, the affiliate's fiscal year. At the direction of BEA, U.S. Reporters would alternate reporting these affiliates on Form BE-11B and Form BE-11E.
(iii) Based on the preceding, an affiliate is exempt from being reported if none of the three items listed in paragraph (f)(3)(ii)(A) of this section exceeds $60 million (positive or negative). However, affiliates that were established or acquired during the year and for which at least one of the items was greater than $25 million but not over $60 million must be listed, and key items reported, on schedule-type Form BE-11D.
(iv) Notwithstanding paragraph (f)(3)(iii) of this section, a Form BE-11B, BE-11C, or BE-11E must be filed for a foreign affiliate of the U.S. Reporter that owns another non-exempt foreign affiliate of that U.S. Reporter, even if the foreign affiliate parent is otherwise exempt. That is, all affiliates upward in the chain of ownership must be reported.
(g)
(2) BE-10-Benchmark Survey of U.S. Direct Investment Abroad: Section 4(b) of the Act (22 U.S.C. 3103) provides that a comprehensive benchmark survey of U.S. direct investment abroad will be conducted in 1982, 1989, and every fifth year thereafter. Exemption levels, specific requirements for, and the year of coverage of, a given BE-10 survey may be found in § 806.16.
3. Section 806.15(j) is revised to read as follows:
(j)
(2) BE-12—Benchmark Survey of Foreign Direct Investment in the United States: Section 4b of the Act (22 U.S.C. 3103) provides that a comprehensive benchmark survey of foreign direct investment in the United States shall be conducted in 1980, 1987, and every fifth year thereafter. The survey is referred to as the “BE-12.” Exemption levels, specific requirements for, and the year of coverage of, a given BE-12 Survey may be found in § 806.17.
4. Section 806.18(b) is revised to read as follows:
(b)
Employee Benefits Security Administration, Department of Labor.
Request for information.
The Department of Labor is reviewing the use of electronic media by employee benefit plans to furnish information to participants and beneficiaries covered by employee benefit plans subject to the Employee Retirement Income Security Act (ERISA). In 2002, the Department adopted standards for the electronic distribution of plan disclosures required under ERISA. The purpose of the review is to explore whether, and possibly how, to expand or modify these standards taking into account current technology, best practices and the need to protect the rights and interests of participants and beneficiaries. This request for information (RFI) solicits views, suggestions, and comments from plan participants and beneficiaries, employers and other plan sponsors, plan administrators, plan service providers, health insurance issuers, and members of the financial community, as well as the general public, on this important issue.
Comments must be submitted on or before June 6, 2011.
You may submit written comments to any of the addresses specified below.
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Thomas M. Hindmarch, Office of Regulations and Interpretations, Employee Benefits Security Administration, (202) 693-8500. This is not a toll-free number.
On July 19, 1977, the Department of Labor (Department) adopted general standards governing the delivery of all information required to be furnished to participants, beneficiaries, and other specified individuals under title I of ERISA.
On January 18, 2011 the President issued Executive Order 13563, “Improving Regulation and Regulatory Review.” Executive Order 13563 reaffirms the importance of achieving regulatory goals through the most innovative and least burdensome tools available. It also emphasizes the importance of public participation in the regulatory process (in section 2) and retrospective consideration of existing regulatory policies (in section 6).
In light of these goals, and in consideration of Administration-wide policies encouraging electronic dissemination of information to the public by federal government agencies consistent with the principles of transparency, participation, and collaboration, EBSA is issuing this RFI to facilitate consideration of its approach to electronic disclosure by employee benefit plans. The Department is aware that electronic disclosure can be as effective as paper based communications, and that it can lower costs and administrative burdens and increase timeliness and accuracy for all involved. The Department also is aware that some of America's workers may not have reasonable access to the Internet, and others may prefer traditional (paper) disclosure methods for important financial interactions regarding their pensions and other employee benefits.
The Department recognizes that there have been substantial changes in technology since over time, both in the workplace and at home, including: The expansion of broadband through cable, fiber optic and wireless networks; hardware improvements to servers and personal computers improving storage, memory, recovery, and computing power; introduction of smart phones, net books and other personal computing devices; and social networking (
At least some evidence suggests that these changes have resulted in a substantial increase in access to and utilization of electronic media. For instance, the 2009 U.S. Census Bureau Current Population Survey (Census) found that 76.7% of the households in the United States have access to the Internet from some location.
Over the past few years, the Department has engaged in various rulemakings and other initiatives involving disclosures to participants and beneficiaries. Examples include the qualified default investment alternative regulation (29 CFR 2550.404c-5), the participant-level fee disclosure regulation (29 CFR 2550.404a-5, 75 FR 64910), the pension benefit statement initiative (FAB 2006-03), the annual funding notice regulation (29 CFR 2520.101-4; FAB 2009-01; proposed § 2520.101-5, 75 FR 70625), and the target date fund initiative (75 FR 73987).
In light of these differing views and the significance of the issues surrounding the use of electronic disclosure, the Department has decided to explore whether and how to expand or modify the current standards under ERISA applicable to the electronic distribution of required plan disclosures. To that end, the Department, through this RFI, is soliciting the views of the public on this important issue. Set forth below are a list of questions.
In considering the questions set forth in this RFI, commenters are encouraged to take into account the following information:
As noted above, on April 9, 2002, the Department established its electronic disclosure safe harbor.
The safe harbor is available only if: (1) The plan administrator takes appropriate and necessary measures reasonably calculated to ensure that the system for furnishing documents results in actual receipt of transmitted information and protects the confidentiality of personal information relating to the individual's accounts and benefits; (2) the electronically delivered documents are prepared and furnished in a manner that is consistent with the style, format and content requirements applicable to the particular document; (3) notice is provided to each participant, beneficiary or other individual, in electronic or non-electronic form, at the time a document is furnished electronically, that apprises the individual of the significance of the document when it is not otherwise reasonably evident as transmitted and of the right to request and obtain a paper version of such document; and (4) upon request, the participant, beneficiary or other individual is furnished a paper version of the electronically furnished documents. § 2520.104b-1(c)(1)(i) through (iv).
The safe harbor applies only for two categories of individual recipients. The first category consists of participants who have the ability to effectively access documents furnished in electronic form at any location where the participant is reasonably expected to perform his or her duties as an employee and with respect to whom access to the employer's or plan sponsor's electronic information system is an integral part of those duties.
In general, the affirmative consent condition requires plans to ensure that an individual has affirmatively consented, in electronic or non-electronic form, to receiving documents through electronic media and has not withdrawn such consent. Alternatively, in the case of documents to be furnished through the Internet or through other electronic communication networks, the individual must have affirmatively consented or confirmed consent electronically, in a manner that reasonably demonstrates the individual's ability to access information in the electronic form that will be used to provide the information that is the subject of the consent, and must have provided an address for the receipt of electronically furnished documents. In addition, prior to consenting, the individual must be provided, in electronic or non-electronic form, a clear and conspicuous statement indicating: (1) The types of documents to which the consent would apply; (2) that consent can be withdrawn at any time without charge; (3) the procedures for withdrawing consent and for updating the participant's, beneficiary's or other individual's address for receipt of electronically furnished documents or other information; (4) the right to request and obtain a paper version of an electronically furnished document, including whether the paper version will be provided free of charge; and (5) any hardware and software requirements for accessing and retaining the documents. Further, following consent, if a change in such hardware or software requirements creates a material risk that the individual will be unable to access or retain electronically furnished documents, the individual: (1) Is provided with a statement of the revised hardware or software requirements for access to and retention of electronically furnished documents; (2) is given the right to withdraw consent without charge and without the imposition of any condition or consequence that was not disclosed at the time of the initial consent; and (3) again consents in accordance with the requirements above. See § 2520.104b-1(c)(2)(ii).
The Department of Treasury and the Internal Revenue Service (IRS) have issued guidance relating to the use of electronic media of notices or elections with respect to a retirement plan. In 2000, final regulations were issued relating to the use of electronic media for the delivery of certain participant notices and consents that are required to be provided in connection with distributions from retirement plans.
In 2003, the Department of Treasury and IRS published final regulations under section 4980F under the Internal Revenue Code (Code) that also apply for purposes of section 204(h) of ERISA (2003 section 4980F regulations).
On October 20, 2006, the Department of Treasury and IRS published final regulations under the Code setting forth standards for electronic systems that make use of an electronic medium to provide a notice to a recipient, or to make a participant election or consent, generally with respect to a retirement plan, an employee benefit arrangement, or an individual retirement plan.
In 2007, the Securities and Exchange Commission (SEC) amended its rules under the Securities Exchange Act of 1934 to provide a method to furnish proxy materials by posting them on an Internet Web site and providing shareholders with notice of the availability of the proxy materials.
On August 9, 2006, and September 21, 2006, a working group of the ERISA Advisory Council held a hearing on numerous issues pertaining to the management of plan assets, including the use of electronic media for disclosures required by regulations under section 404(c) of ERISA. Thirteen witnesses testified at this hearing. In response to this hearing, the working group issued the “Report of the Working Group on Prudent Investment Process.” With respect to the Department's electronic disclosure safe harbor as applied to defined contribution pension plans, the Report states:
The Working Group would like to recommend to the Department of Labor that the Department should reconsider its rules for electronic transfer of notices and the delivery of `sufficient information.' The Working Group heard extensive testimony regarding the growth of the internet and its use by plan participants. Access to and use of the internet has grown significantly since the DOL first considered electronic delivery. The Working Group recommends that the electronic delivery standard should be relaxed from the `integral part of the employee's duties' standard currently employed to a `reasonable access' standard.
On July 12, 2007 and September 18, 2007, a working group of the ERISA Advisory Council held a public hearing on the pension benefit statement requirements under section 105 of ERISA, as amended by section 508 of the Pension Protection Act of 2006, Public Law 109-280, 120 Stat. 949-952. Thirteen witnesses testified at this hearing. In response to this hearing, the working group issued the “Report of the Working Group on Participant Benefit Statements.” In this Report, the Working Group recommended that “the Department of Labor should update its regulations regarding electronic communication to a `reasonable access' standard as in the Department of Treasury safe harbor regulation in recognition of the continued advancement in Web-based communication and the increase in its use by participants.” In support of this recommendation, the Report explains:
Following an animated discussion, the Working Group came to a consensus that although the American workforce is becoming more computer literate, it is not yet appropriate to make electronic delivery of participant statements the norm. In addition to access and ability to use issues, many participants who are computer literate are better served with paper when managing their plan asset. However, the Treasury rules regarding communication provide incentive for plan sponsors to migrate to electronic delivery. In any event, the new regulations should reexamine the use of electronic communication for benefit statements to recognize the changes in technology and the participant group's use of it.
On July 23, 2009 and September 15, 2009, the ERISA Advisory Council, in furtherance of its focus on the issue of promoting retirement literacy and security by streamlining disclosures to participants and beneficiaries, held a public hearing to study the efficacy of ERISA's reporting and disclosure schemes, as well as problems and costs related to such disclosures. Approximately 18 witnesses testified at this hearing. Upon conclusion of the hearing, the full ERISA Advisory Council reached consensus and issued a report entitled “Promoting Retirement Literacy and Security by Streamlining Disclosures.” In this Report, the Council recommended that:
[T]he Department of Labor permits plan administrators to rely on the IRS Regulations in order to comply with ERISA's disclosure requirements. The Council believes that the IRS Regulations will adequately protect the rights of those participants who are actively employed because it will generally be very simple for administrators to determine whether active employees have reasonable access to the electronic medium used to furnish the disclosure. The Council believes that administrators will not furnish those individuals who are not working actively—such as retirees or beneficiaries—with electronic disclosure unless the administrator has a working electronic mail address for such individuals. In that way, participants who are not actively employed and plan beneficiaries will be protected.
Electronic communications have enormously improved the retirement system for both plans covered by ERISA and their participants. They have improved participant education, retirement planning, and plan participation. Electronic communications have allowed plans to furnish more information to participants and beneficiaries for less cost. They have simplified plan administration and improved plan recordkeeping. All of these benefits of electronic communication have improved retirement security, which was and remains an underlying goal of ERISA. The Council believes that this goal of retirement security would be better served if the DOL would expand the array of electronic media that plan administrators may use to satisfy ERISA's disclosure requirements.
The Electronic Signatures in Global and National Commerce Act (E-SIGN), 17 U.S.C. 7001-7021, generally provides that electronic records and signatures have the same legal effect as their paper counterparts.
The purpose of this RFI is to solicit views, suggestions and comments from plan participants and beneficiaries, employers and other plan sponsors, plan administrators, plan service providers, health insurance issuers, and members of the financial community, as well as the general public on whether, and possibly how, to expand or modify the Department's current electronic disclosure safe harbor. To facilitate consideration of the issues, the Department has set forth below a number of questions. Respondents need not answer every question, but should identify, by its number, each question addressed. Interested persons are also encouraged to address any other matters they believe germane to the general topic of the RFI.
1. What percentage of people in this country has access to the Internet at work or home? Of this percentage, what percentage has access at work versus at home? Does access vary by demographic groups (
2. What percentage of participants and beneficiaries covered by an ERISA plan has access to the Internet at work or home? Of this percentage, what percentage has access at work, at home, or both? Does access vary by demographic groups (
3. What percentage of pension benefit plans covered by ERISA currently furnish some or all disclosures required by ERISA electronically to some or all participants and beneficiaries covered under these plans? Please be specific regarding types of plans (
4. What percentage of employee welfare benefit plans covered by ERISA currently furnish some or all disclosures required by ERISA electronically to some or all participants and beneficiaries covered under these plans? Please be specific regarding types of welfare plans (
5. What are the most common methods of furnishing information electronically (
6. What are the most significant impediments to increasing the use of electronic media (
7. Is there evidence to suggest that any increase in participant and beneficiary access to, and usage of, the Internet and similar electronic media in general equates to an increased desire or willingness on the part of those participants and beneficiaries to receive employee benefit plan information electronically? If so, what is it?
8. Are there any new or evolving technologies that might impact electronic disclosure in the foreseeable future?
9. Should the Department's current electronic disclosure safe harbor be revised? If so, why? If not, why not?
10. If the safe harbor should be revised, how should it be revised? Please be specific.
11. Should a revised safe harbor have different rules or conditions for different types of employee benefit plans (
12. Should a revised safe harbor have different rules or conditions for different types of disclosures (
13. Should a revised safe harbor have different rules or conditions for different recipients entitled to disclosures (active employees, retirees, COBRA Qualified Beneficiaries,
14. To what extent should the Department encourage or require pension and welfare benefit plans to furnish some or all disclosures required under title I of ERISA through a continuous access Web site(s)? In responding to this question, please address whether and how frequently participants and beneficiaries should be notified of their ability to access benefit information at the Web site(s) and the most appropriate means to provide such notice. For example, should participants and beneficiaries receive a monthly notification of their ability to access benefit information or should they receive a notification only when an ERISA-required disclosure is added to the Web site? How should such notifications be furnished (
15. Who, as between plan sponsors and participants, should decide whether disclosures are furnished electronically? For example, should participants have to opt into or out of electronic disclosures?
16. Should a revised safe harbor contain conditions to ensure that individuals with disabilities are able to access disclosures made through electronic media, such as via continuous access Web sites? If so, please describe the conditions that would be needed. Also, please identify whether such conditions would impose any undue burdens on employee benefit plans, including the costs associated with meeting any such conditions. What burden and difficulty would be placed on employees with disabilities if the Web sites and/or other electronic communication were not accessible?
17. If a plan furnishes disclosures through electronic media, under what circumstances should participants and beneficiaries have a right to opt out and receive only paper disclosures?
18. The Department's current regulation has provisions pertaining to hardware and software requirements for accessing and retaining electronically furnished information. In light of changes in technology, are these provisions adequate to ensure that participants and beneficiaries, especially former employees with rights to benefits under the plan, have compatible hardware and software for receiving the documents distributed to their non-work e-mail accounts?
19. Some have indicated that the affirmative consent requirement in the Department's current electronic disclosure safe harbor is an impediment to plans that otherwise would elect to use electronic media. How specifically is this requirement an impediment? Should this requirement be eliminated? Is the affirmative consent requirement a substantial burden on electronic commerce? If yes, how? Would eliminating the requirement increase a material risk of harm to participants and beneficiaries? If yes, how?
20. In general, the E-SIGN Act permits electronic disclosure of health plan materials but does not apply to cancellation or termination of health insurance or benefits electronically. Are there special considerations the Department should take into account for group health plan disclosures (including termination of coverage and privacy issues)?
21. Many group health plan disclosures are time-sensitive (
22. Do spam filters and similar measures used by non-workplace (personal) e-mail accounts, pose particular problems that should be taken into consideration?
23. What is the current practice for confirming that a participant received a time-sensitive notice that requires a participant response?
24. What are current practices for ensuring that the e-mail address on file for the participant is the most current e-mail address? For example, what are the current practices for obtaining and updating e-mail addresses of participants who lose their work e-mail address upon cessation of employment or transfer to a job position that does not provide access to an employer provided computer?
Executive Order 12866 (EO 12866) requires an assessment of the anticipated costs and benefits to the government and the public of a significant rulemaking action, and of the alternatives considered, using the guidance provided by the Office of Management and Budget. Under EO 12866, a determination must be made whether implementation of this rule will be economically significant. A rule that has an annual effect on the economy of $100 million or more is considered economically significant.
In addition, the Regulatory Flexibility Act may require the preparation of an analysis of the impact on small entities of proposed rules and regulatory alternatives. A regulatory flexibility analysis must generally include, among other things, an estimate of the number of small entities subject to the regulations (for this purpose, plans, employers, and issuers and, in some contexts small governmental entities), the expense of the reporting, recordkeeping, and other compliance requirements (including the expense of using professional expertise), and a description of any significant regulatory alternatives considered that would accomplish the stated objectives of the statute and minimize the impact on small entities. For this purpose, the Agency considers a small entity to be an employee benefit plan with fewer than 100 participants.
The Paperwork Reduction Act requires an estimate of how many “respondents” will be required to comply with any “collection of information” requirements contained in regulations and how much time and cost will be incurred as a result. A collection of information includes recordkeeping, reporting to governmental agencies, and third-party disclosures.
The Department is requesting comments that may contribute to the analyses that will be performed under these requirements, both generally and
25. What costs and benefits are associated with expanding electronic distribution of required plan disclosures? Do costs and benefits vary across different types of participants, sponsors, plans, or disclosures? Are the printing costs being transferred from plans to plan participants and beneficiaries when information is furnished electronically?
26. If electronic disclosure were the default method for distributing required plan disclosures, and assuming “opting out” were an option, what percentage of participants would likely “opt-out” of electronic disclosure in order to receive paper disclosures? Should participants be informed of increased plan costs, if any, attendant to furnishing paper disclosures at the time they are afforded the option to opt out or into an electronic disclosure regime?
27. Do participants prefer receiving certain plan documents on paper rather than electronically (
28. What impact would expanding electronic disclosure have on small plans? Are there unique costs or benefits for small plans? What special considerations, if any, are required for small plans?
29. Is it more efficient to send an e-mail with the disclosure attached (e.g., as a PDF file) versus a link to a Web site? Which means of furnishing is more secure? Which means of furnishing would increase the likelihood that a worker will receive, read, retain and act upon the disclosure?
30. Employee benefit plans often are subject to more than one applicable disclosure law (
Coast Guard, DHS.
Notice of proposed rulemaking.
The Coast Guard is proposing to amend 33 CFR 165.1305 to expand the established safety zone during the annual Tacoma Freedom Air Show on the fourth of July. The proposed safety zone expansion would establish a larger clear area for low flying aircraft during this event. This rule is necessary to help ensure the safety of the maritime public and event participants during this annual event and will do so by prohibiting any person or vessel from entering or remaining within the safety zone during this event.
Comments and related material must be received by the Coast Guard on or before May 9, 2011. Requests for public meetings must be received by the Coast Guard on or before May 9, 2011.
You may submit comments identified by docket number USCG-2011-0197 using any one of the following methods:
(1)
(2)
(3)
(4)
To avoid duplication, please use only one of these four methods. See the “Public Participation and Request for Comments” portion of the
If you have questions on this proposed rule, call or e-mail Ensign Anthony P. LaBoy, USCG Sector Puget Sound Waterways Management Division, Coast Guard; telephone 206-217-6323, e-mail
We encourage you to participate in this rulemaking by submitting comments and related materials. All comments received will be posted without change to
If you submit a comment, please include the docket number for this rulemaking (USCG-2011-0197), 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
To submit your comment online, go to
To view comments, as well as documents mentioned in this preamble as being available in the docket, go to
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
We do not now plan to hold a public meeting. But you may submit a request for one using one of the four methods specified under
For information on facilities or services for individuals with disabilities or to request special assistance at the public meeting, contact Ensign Anthony P. LaBoy at the telephone number or e-mail address indicated under the
The Coast Guard is proposing to modify the boundaries of the safety zone established in 33 CFR 165.1305. In general, this safety zone is necessary because of the numerous potential hazards associated with the Tacoma Freedom Fair Air Show events. The proposed modification is necessary because the air show has expanded since the initial final rule was codified and the event sponsor has requested a larger safety zone to protect participants and spectators. In addition, expanding the zone would allow safety vessels to patrol inside the safety zone and would minimize vessel traffic along the shoreline which could impede the movement of the safety vessels.
The safety zone created by this proposed rule encompasses all waters bounded by the following points Latitude 47°17′38″ N, Longitude 122°28′43″ W; thence south easterly to Latitude 47°17′4″ N, Longitude 122°27′32″ W; thence south westerly to Latitude 47°16′35″ N, Longitude 122°28′1″ W; thence north westerly along the shoreline to Latitude 47°17′10″ N, Longitude 122°29′14″ W; thence returning to the origin. This safety zone resembles a rectangle protruding from the shoreline along Ruston Way. Floating markers will be placed by the sponsor of the event to delineate the boundaries of the safety zone. All persons and vessels are prohibited from entering or remaining in the safety zone unless authorized by the Captain of the Port, Puget Sound or Designated Representative. The Captain of the Port Puget Sound may be assisted by other local, state, and Federal agencies in the enforcement of this safety zone.
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.
This proposed rule is not a significant regulatory action under section 3(f) of Executive Order 12866, Regulatory Planning and Review, 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.
The Coast Guard bases this finding on the fact that the safety zone is small in size, short in duration, and maritime traffic will be able to safely transit the area outside of this safety zone. Maritime traffic may also request permission to transit through the zone from the Captain of the Port, Puget Sound or Designated Representative.
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 enter or transit in a portion of Commencement Bay, Tacoma, Washington on July 4th from 2 p.m. until 12:30 a.m. July 5th, annually. This safety zone will not have a significant economic impact on a substantial number of small entities, because the safety zone is short in duration, minimal in size, and maritime traffic will be allowed to transit through the safety zone with permission.
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 (
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 Ensign Anthony P. LaBoy at the telephone number or e-mail address indicated under the
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.
This proposed rule would call for no new collection of information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).
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
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.
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.
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.
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.
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.
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.
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 (
This proposed rule does not use technical standards. Therefore, we did not consider the use of voluntary consensus standards.
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 which do not individually or cumulatively have a significant effect on the human environment. A preliminary environmental analysis checklist supporting this determination will be made available in the docket where indicated under
Harbors, Marine safety, Navigation (water), Reporting and recordkeeping requirements, Security measures, Waterways.
For the reasons discussed in the preamble, the Coast Guard proposes to amend 33 CFR part 165, as follows:
1. The authority citation for Part 165 continues to read as follows:
33 U.S.C. 1231; 46 U.S.C. Chapter 701, 3306, 3703; 50 U.S.C. 191, 195; 33 CFR 1.05-1(g), 6.04-1, 6.04-6, 160.5; Pub. L. 107-295, 116 Stat. 2064; Department of Homeland Security Delegation No. 0170.1.
2. The Coast Guard proposes to amend § 165.1305 by revising paragraph (a) to read as follows:
(a)
Environmental Protection Agency (EPA).
Proposed rule.
EPA is proposing to approve a portion of the State Implementation Plan (SIP) revision submitted by the State of Oregon for the purpose of addressing the interstate transport provisions of Clean Air Act (CAA) section 110(a)(2)(D)(i)(I) for the 1997 8-hour ozone National Ambient Air
Written comments must be received on or before May 9, 2011.
Submit your comments, identified by Docket ID No. EPA-R10-OAR-2011-0003, by one of the following methods:
A.
B.
C.
D.
Donna Deneen, (206) 553-6706 or
Throughout this notice, the words “we”, “us”, or “our” means the Environmental Protection Agency (EPA).
EPA is proposing to approve a portion of Oregon's Interstate Transport State Implementation Plan (SIP) revision for the 1997 8-hour ozone and 1997 PM
Section 110(a) of the CAA requires each state to develop a plan that provides for the implementation, maintenance, and enforcement of the NAAQS. EPA establishes NAAQS under section 109 of the CAA. Currently, the NAAQS address six criteria pollutants: Carbon monoxide, nitrogen dioxide, ozone, lead, particulate matter, and sulfur dioxide.
The plan developed by a state is referred to as the SIP. The content of the SIP is specified in section 110 of the CAA, other provisions of the CAA, and applicable regulations. SIPs can be extensive, containing state regulations or other enforceable measures and various types of supporting information, such as emissions inventories, monitoring networks, and modeling demonstrations.
A primary purpose of the SIP is to provide the air pollution regulations, control strategies, and other means or techniques developed by the state to
States are required to update or revise SIPs under certain circumstances. One such circumstance is EPA's promulgation of a new or revised NAAQS. Each state must submit these revisions to EPA for approval and incorporation into the federally-enforceable SIP.
On July 18, 1997, EPA promulgated new standards for 8-hour ozone
Section 110(a)(1) of the CAA requires states to submit SIPs to address a new or revised NAAQS within three years after promulgation of such standards, or within such shorter period as EPA may prescribe. Section 110(a)(2) lists the elements that such new SIPs must address, as applicable, including section 110(a)(2)(D)(i) which pertains to interstate transport of certain emissions. On August 15, 2006, EPA issued a guidance memorandum that provides recommendations to states for making submissions to meet the requirements of section 110(a)(2)(D)(i) for the 1997 8-hour ozone and 1997 PM
The interstate transport SIP provisions in section 110(a)(2)(D)(i) (also called “good neighbor” provisions) require each state to submit a SIP that prohibits emissions that adversely affect another state in the ways contemplated in the statute. Section 110(a)(2)(D)(i) identifies four distinct elements related to the evaluation of impacts of interstate transport of air pollutants. In this rulemaking EPA is addressing the first two elements of this subsection.
The first element of section 110(a)(2)(D)(i)(I) requires that a state's SIP for a new or revised NAAQS must contain adequate measures to prohibit emissions from sources within the state that “contribute significantly” to nonattainment of the NAAQS in another state. The second element of CAA section 110(a)(2)(D)(i)(I) requires that a state's SIP must prohibit any source or other type of emissions activity in the state from emitting pollutants that will “interfere with maintenance” of the applicable NAAQS in any other state.
The CAA does not specifically mandate how to determine significant contribution to nonattainment or interference with maintenance. Therefore, EPA has interpreted these terms in past regulatory actions, such as the 1998 NO
After promulgation of the 1997 8-hour ozone NAAQS and the 1997 PM
EPA's 2006 Guidance addressed CAA section 110(a)(2)(D)(i) requirements for the 1997 8-hour ozone NAAQS and 1997 PM
The assessment of significant contribution to nonattainment is not restricted to impacts upon areas that are formally designated nonattainment. Consistent with EPA's approach in CAIR and recently in the Transport Rule
As to the second element of section 110(a)(2)(D)(i), for states not within the CAIR region, EPA recommended that states evaluate whether or not emissions from their sources would “interfere with maintenance” in other states following the conceptual approach adopted by EPA in CAIR. After recommending various types of information that could be relevant for the technical analysis to support the SIP submission, such as the amount of emissions and meteorological conditions in the state, EPA further indicated that it would be appropriate for the state to assess impacts of its emissions on other states using considerations comparable to those used by EPA “in evaluating significant contribution to nonattainment in the CAIR.”
In 2008, the U.S. Court of Appeals for the D.C. Circuit found that CAIR and the related CAIR federal implementation plans were unlawful.
To address the judicial remand of CAIR, EPA has recently proposed a new rule to address interstate transport of air pollution pursuant to section 110(a)(2)(D)(i), the “Federal Implementation Plans to Reduce Interstate Transport of Fine Particulate Matter and Ozone” (Transport Rule Proposal).
As described in more detail below, EPA evaluated data from existing monitors over three overlapping 3-year periods (
By this method, EPA has identified those areas with monitors that are appropriate “nonattainment receptors” or “maintenance receptors” for evaluating whether the emissions from sources in another state could significantly contribute to nonattainment in, or interfere with maintenance in, that particular area. EPA believes that this approach for identifying areas that are predicted to be nonattainment or to have difficulty maintaining the NAAQS, is appropriate to evaluate a state's submission in relation to the elements of CAA section 110(a)(2)(D)(i)(I) pertaining to significant contribution to nonattainment and interference with maintenance.
As explained in the 2006 Guidance, EPA does not believe that section 110(a)(2)(D)(i) SIP submissions from all states necessarily need to follow precisely the same analytical approach of CAIR. In the 2006 Guidance, EPA stated that: “EPA believes that the contents of the SIP submission required by section 110(a)(2)(D) may vary, depending upon the facts and circumstances related to the specific NAAQS. In particular, the data and analytical tools available at the time the State develops and submits a SIP for a new or revised NAAQS necessarily
Accordingly, EPA believes that section 110(a)(2)(D)(i) SIP submissions for states outside the geographic area of the Transport Rule Proposal may be evaluated using a “weight of the evidence” approach that takes into account the available relevant information, such as that recommended by EPA in the 2006 Guidance for states outside the area affected by CAIR. Such information may include, but is not limited to, the amount of emissions in the state relevant to the NAAQS in question, the meteorological conditions in the area, the distance from the state to the nearest monitors in other states that are appropriate receptors, or such other information as may be probative to consider whether sources in the state may significantly contribute to nonattainment or interfere with maintenance of the 1997 8-hour ozone and 1997 PM
CAA sections 110(a)(1) and (2) and section 110(l) require that revisions to a SIP be adopted by the State after reasonable notice and public hearing. EPA has promulgated specific procedural requirements for SIP revisions in 40 CFR part 51, subpart F. These requirements include publication of notices, by prominent advertisement in the relevant geographic area, of a public hearing on the proposed revisions, a public comment period of at least 30 days, and an opportunity for a public hearing.
On June 23, 2010, and December 23, 2010, the Oregon Department of Environmental Quality (ODEQ) submitted a SIP revision to update Oregon's infrastructure SIP for ozone and PM
We find that the process followed by ODEQ in adopting the 2010 interstate transport SIP complies with the procedural requirements for SIP revisions under CAA section 110 and EPA's implementing regulations.
This proposed approval evaluates the significant contribution to nonattainment element of section 110(a)(2)(D)(i)(I) for the 1997 8-hour ozone and 1997 PM
Finally, EPA has also reviewed recent ozone and PM
To address whether emissions from Oregon sources significantly contribute to nonattainment of the 8-hour ozone NAAQS in another state, the State argued in the 2010 interstate transport SIP that meteorological and other characteristics of the Pacific Northwest support a finding that emissions from Oregon sources do not significantly contribute to violations of the PM
Oregon also pointed to its section 110 infrastructure SIP to show that ODEQ
Finally, the State explained that it consulted with air agencies in Washington, Idaho, Nevada, and California and other agencies to evaluate case-specific air quality problems that may involve regional transport of air pollution. These staff-level communications indicated no impacts on ozone concentrations in other states caused by transport from the State of Oregon. The State added that if any future violations of ozone standards occur, Oregon would work with other air agencies and EPA as necessary to evaluate the role of interstate air pollution transport. This consultation provided additional support for the state's view that emissions from Oregon sources do not significantly contribute to violations of the 1997 8-hour ozone NAAQS in other states.
Based on the information provided in its 2010 interstate transport SIP, ODEQ concluded that emissions from air pollution sources in Oregon do not significantly contribute to nonattainment of the 1997 8-hour ozone NAAQS in other states.
EPA does not necessarily agree that Oregon's methodology is adequate for purposes of a section 110(a)(2)(D)(i) analysis. Therefore, EPA is supplementing the State's submission with additional, and more recent, information in order to assess this issue more fully. As noted above, EPA is evaluating the State's 2010 interstate transport SIP taking into account methodologies and analyses for the identification of receptor monitors that was developed in the Transport Rule Proposal, as well as EPA's projections of future air quality at monitors in western states in the Timin Memo, and preliminary air quality data from monitors in the states bordering Oregon. Although each of the factors considered in the following analysis are not in and of themselves determinative, consideration of these factors together provides a reliable qualitative conclusion that emissions from Oregon do not contribute significantly to nonattainment of the 1997 8-hour ozone NAAQS at monitors in other states.
The Transport Rule Proposal includes an approach to determining whether emissions from a state contribute significantly to nonattainment of the 1997 8-hour ozone NAAQS in other states. Specifically, EPA used existing monitoring data to project future concentrations of ozone at monitors to identify areas that are expected to be violating the 1997 8-hour ozone NAAQS in 2012, based on the 5-year weighted average design value. We call these monitors “nonattainment receptors.” To identify the states with emissions that may contribute significantly to ozone nonattainment in other states, the Transport Rule Proposal models the states' contributions to ambient ozone levels at these nonattainment receptors.
Our analysis begins by assessing Oregon's contribution to the closest nonattainment receptors for the 1997 8-hour ozone standard. The Transport Rule Proposal identifies within its modeling domain (consisting of 37 states east of the Rocky Mountains, and the District of Columbia) 11 nonattainment receptors for the 1997 8-hour ozone standard. Of these, the nonattainment receptors closest to Oregon are seven receptors in the Dallas-Fort Worth and Houston-Galveston-Brazoria 8-hour ozone nonattainment areas in eastern Texas. The remaining four nonattainment receptors for the 1997 8-hour ozone NAAQS are in Louisiana, New York, and Pennsylvania.
The nonattainment receptors in Dallas-Fort Worth and Houston areas are over 1200 miles from the closest point on Oregon's border, and the receptors in Louisiana, New York, and Pennsylvania are significantly further away. Although distance alone is not determinative in the analysis of potential ozone transport, with increasing distance there are greater opportunities for ozone and NO
To assist in the evaluation of the potential for ozone transport among western states, EPA also developed an additional analysis in the Timin Memo identifying monitors projected to record violations of the 1997 8-hour ozone NAAQS in the western U.S. The Timin Memo identified predicted future nonattainment receptors for the 1997 8-hour ozone NAAQS in southern and central California. This analysis did not, however, identify any projected nonattainment receptors for the 1997 8-hour ozone NAAQS in any other western state.
In addition to the information in the 2010 interstate transport SIP and EPA's projections of future air quality in the Transport Rule Proposal and in the
We also evaluated ozone monitoring data from the 2007-2009 period from each of the ozone monitoring sites in Washington, Idaho, Nevada and California, to determine whether the ozone levels in any of these states violate the 1997 8-hour ozone NAAQS.
Finally, none of the ozone monitors in Oregon have themselves indicated a violation of the 1997 8-hour ozone NAAQS. The absence of violations in Oregon itself does not rule out the possibility of transport, but taken in conjunction with other relevant information, including the distance from Oregon to areas with design values above the 1997 8-hour ozone NAAQS and Pacific Northwest meteorology and topography, this fact helps to support the conclusion that there is no transport from Oregon resulting in significant contribution to nonattainment in another state. Distance
To address whether emissions from sources in Oregon significantly contribute to nonattainment of the 1997 PM
Oregon described typical seasonal wind patterns during the winter when PM
Oregon also pointed to its section 110 infrastructure SIP to show that ODEQ has the ability to participate as needed in future studies on regional air pollution issues, or collaborate with other states if air quality concerns are identified that require a case-specific evaluation of interstate transport, and also ensures the legal mechanism for ODEQ to take action as needed to reduce emissions to help attain compliance with Federal NAAQS. Oregon stated that that high PM
Finally, the state explained that it had consulted with air agencies in Washington, Idaho, Nevada, and California and other agencies to evaluate case-specific air quality problems that may involve regional transport of air pollution. These staff-level communications indicated no impacts on PM
Based on this and other information provided in its 2010 interstate transport SIP, ODEQ concluded that emissions from air pollution sources in Oregon do not significantly contribute to nonattainment of the 1997 PM
EPA does not necessarily agree that Oregon's methodology is adequate for purposes of a section 110(a)(2)(D)(i) analysis. Therefore, EPA is supplementing the State's submission with additional, and more recent, information in order to assess this issue more fully. As noted above, EPA is evaluating the 2010 interstate transport SIP taking into account methodologies and analyses for the identification of the receptor monitors that was developed in the Transport Rule Proposal, as well as EPA's projections of future air quality at monitors in western states in the Timin Memo, and air quality data from monitors in the states bordering Oregon. Although each of the factors considered in the following analysis are not in and of themselves determinative, consideration of these factors together provides a reliable qualitative conclusion that emissions from Oregon do not contribute significantly to nonattainment of the PM
Specifically, we identified the nonattainment receptors for the 1997 annual PM
To address the potential for PM
The analysis for the Transport Rule Proposal did not identify any nonattainment receptors for the 1997 24-hour PM
In addition to the information in the 2010 interstate transport SIP and our review of the nearest nonattainment receptors identified from the modeling analyses conducted for the Transport Rule Proposal, EPA evaluated air quality data for the areas in states bordering Oregon that are designated nonattainment for the 1997 PM
The closest 1997 PM
Although not located in a state bordering Oregon, the closest designated nonattainment area to Oregon for the 1997 PM
First, in the process of designating Libby nonattainment for both the 1997 PM
Second, monitoring data from 1999 through 2009 from areas outside of Libby in Montana support a determination that Oregon does not significantly contribute to nonattainment in Libby. At all other sites in Montana, annual PM
Third, for 2007-2009, AQS data show that the annual PM
Finally, EPA's conclusion that emissions from Oregon do not significantly contribute to nonattainment in Libby, Montana, is further supported by the analysis of monitors in the western United States.
As mentioned above, EPA considers not only significant contribution to designated nonattainment areas, but also significant contribution to areas with monitors showing violations of the NAAQS. A review of the most recent three years (2007-2009) of monitoring data in AQS for the bordering states of Washington, Idaho, Nevada, and California shows that the only monitors with design values above the 1997 annual PM
As noted above no monitors in Washington, Idaho and Nevada or Northern California had design values above the 1997 annual PM
Finally, none of the PM
Based on the weight of evidence discussed above, including the location of the nearest projected nonattainment receptors, distance to the nearest designated PM
This proposed approval evaluates the interfere with maintenance element of section of section 110(a)(2)(D)(i)(I) for the 1997 8-hour ozone and 1997 PM
To show that Oregon emissions, as controlled under its SIP, do not interfere with maintenance of the 1997 8-hour ozone NAAQS and 1997 PM
Second, Oregon used AQS monitoring data for 2006-2008 from other states in its analysis. Oregon pointed out that both PM
Oregon also relied on information about air stagnation conditions in other states to support its assertions that Oregon sources do not interfere with maintenance of the 1997 8-hour ozone NAAQS and 1997 PM
Finally, Oregon pointed to its section 110 infrastructure SIP to show that ODEQ has the ability to participate as needed in future studies on regional air pollution issues, or collaborate with
EPA does not necessarily agree that Oregon's methodology is adequate for purposes of a section 110(a)(2)(D)(i) analysis. Therefore, EPA is supplementing the State's submission with additional, and more recent, information in order to assess this issue more fully. As noted above, EPA is evaluating the 2010 interstate transport SIP taking into account methodologies and analyses for the identification of the receptor monitors that was developed in the Transport Rule Proposal, as well as EPA's projections of future air quality at monitors in western states in the Timin Memo and preliminary air quality data from monitors in the states bordering Oregon. Although each of the factors considered in the following analysis are not in and of themselves determinative, consideration of these factors together provides a reliable qualitative conclusion that emissions from Oregon do not interfere with maintenance of the 1997 8-hour ozone and PM
As discussed above, in the Transport Rule Proposal, EPA projected future concentrations of ozone at monitors to identify areas that are expected to be violating the NAAQS or to have difficulty maintaining compliance with the NAAQS in 2012. For purposes of the interference with maintenance evaluation, EPA projected future concentrations of ozone at monitors to identify areas that are expected to have a maximum design value (based on a single 3-year period) that exceeds the 1997 8-hour ozone NAAQS, and EPA anticipates that by 2012 these maintenance receptors will have difficulty in maintaining attainment of the NAAQS if there are adverse variations in meteorology or emissions.
To identify the states with emissions that may cause interference with maintenance of the NAAQS at maintenance receptors, the Transport Rule Proposal modeled the states' contributions to ambient ozone levels at these maintenance receptors.
Our analysis begins by assessing Oregon's contribution to the closest maintenance receptors for the 1997 8-hour ozone standard. The Transport Rule Proposal identifies 16 maintenance receptors for the 1997 8-hour ozone standard within its modeling domain (consisting of 37 states east of the Rocky Mountains, and the District of Columbia). Of these, the receptors closest to Oregon are eight receptors in the Dallas-Fort Worth and Houston-Galveston-Brazoria 8-hour ozone nonattainment areas in eastern Texas. The remaining eight maintenance receptors are located in Connecticut, Georgia, New York and Pennsylvania.
As discussed above in section V.A.1, the Dallas-Fort Worth and Houston areas are over 1200 miles from the closest point on Oregon's border. The maintenance receptor monitors located in Connecticut, Georgia, New York and Pennsylvania are significantly further away. Although distance alone is not determinative in the analysis of potential ozone transport, with increasing distance there are greater opportunities for ozone and NO
EPA's analysis in the Timin Memo identified four maintenance receptors for the 1997 8-hour ozone NAAQS in southern and central California.
Finally, none of the ozone monitors in Oregon have themselves indicated a violation of the 1997 8-hour ozone NAAQS. The absence of violations in Oregon itself does not rule out the possibility of transport, but taken in conjunction with other relevant information, including the distance from Oregon to areas with design values above the 1997 8-hour ozone NAAQS and Pacific Northwest meteorology and topography, this fact helps to support a conclusion that there is no transport from Oregon resulting in interference with maintenance in another state. Taking into account the total weight of all of the factors discussed above, EPA concludes that Oregon does not interfere with maintenance of the 1997 8-hour ozone NAAQS in any other state.
The Transport Rule Proposal identifies within its modeling domain 16 predicted future maintenance receptors for the 1997 annual PM
EPA's analysis in the Timin Memo identified Los Angeles County, California, as the closest projected maintenance receptor to Oregon's border. Los Angeles County is located almost 500 miles south of the closest point on Oregon's border and is on the other side of intervening mountain ranges that act as a natural barrier to air pollution transport. Although not determinative by themselves, distance and topography are not favorable to PM
The analysis for the Transport Rule Proposal did not identify any maintenance receptors for the 1997 24-hour PM
Based on the weight of evidence, including the location of the nearest projected maintenance sites, taking into account distance, meteorology, topography, and recent air quality monitoring data, as discussed above, we propose to determine that Oregon's 2010 interstate transport SIP is adequate and that emissions from Oregon do not interfere with maintenance in any other state for the 1997 8-hour ozone or 1997 PM
In light of the data and the weight of evidence analysis presented above, EPA is proposing to approve revisions to the Oregon SIP, submitted on June 23, 2010, and December 23, 2010, and concludes that for the 1997 8-hour ozone and 1997 PM
As noted previously, EPA will address element (3) interference with any other state's required measures to prevent significant deterioration of its air quality and element (4), interference with any other state's required measures to protect visibility, in a separate action. EPA will also take action on the portion of Oregon's SIP that addresses the 2006 PM
Under the Clean Air Act, the Administrator is required to approve a SIP submission that complies with the provisions of the Act and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the Clean Air Act. Accordingly, this action merely proposes to approve state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the Clean Air Act; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this proposed rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country
Environmental protection, Air pollution control, Incorporation by reference, Intergovernmental relations, Ozone, Particulate matter, Reporting and recordkeeping requirements, Volatile organic compounds.
Fish and Wildlife Service, Interior.
Proposed rule; reopening of comment period and announcement of public hearings.
We, the U.S. Fish and Wildlife Service, announce the reopening of the public comment period on the December 14, 2010, proposed rule to list the dunes sagebrush lizard
We will consider comments received on or before May 9, 2011. Comments must be received by 11:59 p.m. Eastern Time on the closing date. Any comments that we receive after the closing date may not be fully considered in the final decision on this action.
We will hold a public informational session from 3:30 p.m. to 5 p.m., followed by a public hearing from 6:30 p.m. to 8 p.m., on each of the following dates:
1. April 27, 2011: Midland, Texas.
2. April 28, 2011: Roswell, New Mexico.
You may submit comments by one of the following methods:
•
•
We will post all comments on
The public informational sessions and hearings will be held at the following locations:
1. Midland, Texas: Midland Center & Centennial Plaza, 105 N. Main Street, Midland, Texas 79701.
2. Roswell, New Mexico: ENMU—Roswell, Performing Arts Center, 64 University Blvd., Roswell, New Mexico 88202.
People needing reasonable accommodations in order to attend and participate in the public hearings should contact Wally “J” Murphy, New Mexico Ecological Services Field Office, at 505-761-4718 as soon as possible (
Wally “J” Murphy, Field Supervisor, New Mexico Ecological Services Field Office, 2105 Osuna NE., Albuquerque, NM 87113; by telephone 505-761-4781 or by facsimile 505-346-2542. Persons who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 800-877-8339.
We will accept written comments and information during this reopened comment period for the proposed rule to list the dunes sagebrush lizard (
(1) Information on the dunes sagebrush lizard relevant to the factors that are the basis for making a listing determination for a species under section 4(a) of the Endangered Species Act of 1973, as amended (Act) (16 U.S.C. 1531
(a) The present or threatened destruction, modification, or curtailment of its habitat or range;
(b) Overutilization for commercial, recreational, scientific, or educational purposes;
(c) Disease or predation;
(d) The inadequacy of existing regulatory mechanisms; or
(e) Other natural or manmade factors affecting its continued existence.
(2) Additional information concerning the range, distribution, and population size of this species, including the locations of any additional populations of this species.
(3) Any information on the biological or ecological requirements of the species.
If you submitted comments or information on the proposed rule (75 FR 77801, December 14, 2010) during the initial comment period from December 14, 2010, to February 14, 2011, please do not resubmit them. We will incorporate them into the public record as part of this comment period, and we will fully consider them in the preparation of our final determination. Our final determination will take into consideration all written comments and any additional information we receive during both comment periods.
You may submit your comments and materials concerning the proposed rule by one of the methods listed in the
We will post your entire comment—including your personal identifying information—on
Comments and materials we receive, as well as supporting documentation we used in preparing the proposed rule,
It is our intent to discuss only those topics directly relevant to the proposed rule to list the dunes sagebrush lizard as endangered in this document.
On December 14, 2010, we published a proposed rule (75 FR 77801) to list the dunes sagebrush lizard, a lizard known from southeastern New Mexico and adjacent west Texas, as endangered under the Act. For a description of previous Federal actions concerning the dunes sagebrush lizard (formerly known as the sand dunes lizard), please refer to the proposed rule. In response to comments received during the initial public comment period, we have decided to allow the public more time to submit comments and to hold informational sessions as described previously.
If we finalize the rule as proposed, it would extend the Act's protections to this species. We have determined that critical habitat for the dunes sagebrush lizard is prudent but not determinable at this time. The final decision on whether to list the dunes sagebrush lizard as endangered will be based on the best scientific data available, including information obtained during the comment period.
The primary authors of this notice are the staff members of the New Mexico Ecological Services Field Office, Region 2, U.S. Fish and Wildlife Service.
The authority for this action is the Endangered Species Act of 1973 (16 U.S.C. 1531
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Advance notice of proposed rulemaking (ANPR); request for comments.
At the request of the New England Fishery Management Council (Council), this notification announces that the Council and NMFS is considering and seeking public comment on, potential changes to the Northeast Multispecies Fishery Management Plan that would be implemented through proposed rulemaking, under the authority of the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), to limit the accumulation of excessive control or ownership of fishing privileges in the NE multispecies groundfish fishery. The date of publication of this notification, April 7, 2011, shall be known as the “control date,” and may be used as a reference date for future management measures related to such rulemaking. In particular this notification is intended to promote awareness of this possible rulemaking; provide notice to the public that any current or future accumulation of fishing privilege interests in the NE multispecies fishery may be affected, restricted, or even nullified; and to discourage speculative behavior in the market for fishing privileges while the Council considers whether and how such limitations on accumulation of fishing privileges should be developed. This notification also gives the public notice that interested participants should locate and preserve records that substantiate and verify their ownership or control of groundfish permits and other fishing privileges in the NE multispecies fishery in Federal waters.
April 7, 2011, shall be known as the “control date” and may be used as a reference date for future management measures related to the maintenance of a fishery with characteristics consistent with the Council's objectives and applicable Federal laws. Written comments must be received on or before 5 p.m., local time, May 9, 2011.
You may submit comments, identified by RIN 0648-BA88, by any one of the following methods:
• Written comments (paper, disk, or CD-ROM) should be sent to Paul J. Howard, Executive Director, New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950. Mark the outside of the envelope, “Comments on Multispecies Accumulation Limits Control Date.”
• Comments also may be sent via facsimile (fax) to (978) 465-3116.
• Submit all electronic public comments via the Federal e-Rulemaking Portal:
NMFS will accept anonymous comments (enter N/A in the required fields, if you wish to remain anonymous). You may submit attachments to electronic comments in Microsoft Word, Excel, WordPerfect, or Adobe PDF file formats only.
Travis Ford, Fishery Management Specialist, 978-281-9233; fax 978-281-9135;
The NE Multispecies FMP manages 20 individual stocks comprised of the following species: Cod, haddock, white hake, pollock, Acadian redfish, yellowtail flounder, winter flounder, witch flounder, American plaice, windowpane flounder, Atlantic halibut, ocean pout, and Atlantic wolffish. The Council has managed most of these species as a unit under the FMP since 1985. Many of these stocks remain overfished, and strict regulations have been adopted to control catch and promote stock rebuilding. Current management measures include limited and open-access permit categories, limits on fishing time through days-at-sea (DAS) allocations, gear requirements, closed areas, retention limits, and sector allocation. These
In the most recent specification process (Framework Adjustment 44 (75 FR 18356)), ACLs for many NE multispecies stocks were set at very low levels. For certain stocks, catch limits are expected to remain low for the near future. Some members of the fishing industry and the Council have expressed concern that the low catch limits, in conjunction with expanded sector management, will lead to excessive consolidation of fishing privileges and lack of diversity in the groundfish fleet. For example, for several stocks, the potential sector contribution (PSC) associated with a small number of vessel owners enrolled in a sector represents a large percentage of the total allocation to the fishery. In addition, NMFS, in its letter to the Council partially approving Amendment 16, requested the Council to consider developing measures that would mitigate potential negative impacts stemming from the consolidation of permits, both within sectors and among individual permit holders, as they relate to some of the social and economic objectives established in the NE multispecies FMP.
In light of these concerns, the Council, at its January, 2011 meeting, requested that “NMFS publish in the
The date of publication of this notification, April 7, 2011, shall be known as the “control date,” and may be used as a reference date for future management measures in determining how to treat fishing privileges acquired before this date and those acquired after this date, depending on the Council's determinations on limiting control and ownership of such privileges. The establishment of a control date, however, does not obligate the Council to use this control date or take any action, nor does it prevent the Council from picking another control date or imposing limits on permits acquired prior to the control date.
Accordingly, this notification is intended to promote awareness that the Council may be developing management measures to address these concerns, to provide notice to the public that any current or future accumulation of fishing privilege interests in the NE multispecies fishery may be affected, restricted, or even nullified, and discourage speculative behavior in the market for fishing privileges while the Council considers whether and how such limitations on accumulation of fishing privileges should be developed. Any measures the Council is considering may require changes to the NE multispecies FMP. Such measures may be adopted in a future amendment to the FMP, which would include opportunity for further public participation and comment.
This notification also gives the public notice that interested participants should locate and preserve records that substantiate and verify their ownership or control of groundfish permits and other fishing privileges in the NE multispecies fishery in Federal waters.
16 U.S.C. 1801
Office of the Secretary, U.S. Department of Agriculture.
Notice of revised system of records; request for comment.
In accordance with the Privacy Act of 1974, as amended, the U.S. Department of Agriculture (USDA) is amending an existing Forest Service Privacy Act system of records, USDA/FS-3, Uniform Allowance System.
Comments must be received in writing, on or before May 9, 2011. The System of Records USDA/FS-3 Uniform Allowance is amended, without further notice, on June 6, 2011, unless modified to respond to comments received from the public and published in a subsequent notice.
Questions can be addressed to the Forest Service Privacy Act Officer, USDA Forest Service, 1400 Independence Avenue, SW., Mail Stop 1143, Washington, DC 20250-1143. Comments may also be sent via e-mail to
Karren Y. Alexander, Director, USDA Forest Service, Financial Management Systems, 1400 Independence Avenue, SW., Mailstop 1149, Washington, DC 20250-1149,
Established in 1905, the Forest Service is an agency of the U.S. Department of Agriculture. The mission of the Forest Service is to sustain the health, diversity, and productivity of the Nation's forests and grasslands that encompass 193 million acres of land, to meet the needs of present and future generations. The purpose of this system is to allow the Forest Service to maintain records that identify individuals who apply for and are approved to purchase and wear the Forest Service uniform.
Pursuant to the Privacy Act (5 U.S.C. 552a), the Forest Service has amended the system of records to include new system location, new system manager, new storage type, new routine uses; and new policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system. This system of records provides information for internal processing purposes to track uniform allowances and expenditures for authorized individuals.
A report of the amended system of records, required by 5 U.S.C. 552a(r) as implemented by Office of Management and Budget (OMB) Circular A-130, was sent to the Chairman, Committee on Homeland Security and Governmental Affairs, United States Senate; the Chairman, Committee on Oversight and Government Reform, U.S. House of Representatives; and the Administrator, Office of Information and Regulatory Affairs, OMB.
Uniform Allowance System (UNAW), USDA/FS-3.
None.
The records in this system are collected in a web-based system located on servers maintained by a Federal contractor in St. Louis, Missouri, and in Omaha, Nebraska. The addresses for the Contractor may be obtained by writing to the Director of Financial Management Systems, USDA Forest Service, 1400 Independence Avenue, SW., Mailstop 1149, Washington, DC 20250-1149. Paper records for use with the uniform system are maintained at Forest Services offices nationwide. The addresses for the Regions, Stations, International Institute for Tropical Forestry, and Forests are listed in 36 CFR Part 200, Subpart A; and the addresses for Districts are in the telephone directory of the applicable locality under the heading, United States Government, Department of Agriculture, Forest Service.
Individuals who are authorized a monetary allowance to purchase and wear a Forest Service uniform while performing official duties.
The system of records consists of completed Forest Service form FS-6100-36 (Uniform Authorization) and information on uniform allowances and expenditures for authorized individuals. Information includes the individual's name, social security number, employee location, allowance category, job code, and current status (active or terminated). The purpose of collecting social security numbers is to administer the uniform allowance program and ensure proper approval, and payment of the individual's uniform allowance.
5 U.S.C. 5901-5903.
Information in this system is used for internal processing purposes to track uniform allowances and expenditures for authorized individuals.
(1) When a record on its face, or in conjunction with other records, indicates a violation or potential violation of law, whether civil, criminal, or regulatory in nature, and whether arising by general statute or particular program statute, or by regulation, rule, or order issued pursuant thereto, disclosure may be made to the appropriate agency, whether Federal, foreign, State, local, or Tribal, or other public authority responsible for enforcing, investigating, or prosecuting such violation or charged with enforcing or implementing the statute, or rule, regulation, or order issued pursuant thereto, if the information disclosed is relevant to any enforcement, regulatory, investigative, or prosecutive responsibility of the receiving entity.
(2) To the Department of Justice when: (a) The agency or any component thereof; or (b) any employee of the agency in his or her official capacity where the Department of Justice has agreed to represent the employee; or (c) the United States Government, is a party to litigation or has an interest in such
(3) To a court or adjudicative body in a proceeding when: (a) The agency or any component thereof; or (b) any employee of the agency in his or her official capacity; or (c) any employee of the agency in his or her individual capacity where the agency has agreed to represent the employee; or (d) the United States Government, is a party to litigation or has an interest in such litigation, and by careful review, the agency determines that the records are both relevant and necessary to the litigation and the use of such records is therefore deemed by the agency to be for a purpose that is compatible with the purpose for which the agency collected the records.
(4) To a Member of Congress or to a Congressional staff member in response to an inquiry of the Congressional office made at the written request of the constituent about whom the record is maintained.
(5) Records from this system of records may be disclosed to the National Archives and Records Administration or to the General Services Administration for records management inspections conducted under 44 U.S.C. 2904 and 2906.
(6) To agency contractors, grantees, experts, consultants, or volunteers who have been engaged by the agency to assist in the performance of a service related to this system of records and who need to have access to the records in order to perform the activity. Recipients shall be required to comply with the requirements of the Privacy Act of 1974, as amended, pursuant to 5 U.S.C. 552a(m).
(7) To appropriate agencies, entities, and persons when: (a) The Forest Service suspects or has confirmed that the security or confidentiality of information in the system of records has been compromised; (b) the Department has determined that as a result of the suspected or confirmed compromise there is a risk of harm to economic or property interests, identity theft or fraud, or harm to the security or integrity of this system or other systems or programs (whether maintained by the Department or another agency or entity) that rely upon the compromised information; and (c) the disclosure made to such agencies, entities, and persons is reasonably necessary to assist in connection with the Department's efforts to respond to the suspected or confirmed compromise and prevent, minimize, or remedy such harm.
None.
Policies and practices for storing, retrieving, accessing, retaining, and disposing of records in the system: Records are maintained in electronic format pursuant to Forest Service file code 6500. Only those specifically authorized individuals can access the information.
All electronic information is maintained in a web-based database and stored on secured servers at St. Louis, Missouri, and on backup copies at Omaha, Nebraska. Hard copy records are maintained, retrievable by employee's name, in locked file cabinets in secured office buildings.
Records are indexed and retrieved electronically using multiple queries including name, social security number, allowance, home unit, or other criteria.
All records containing personal information are maintained electronically in secured computer rooms. Access to the database and all electronic folders with personal information are password protected and stored on secure servers. Computer access to information provided by applicants is limited to the individual employee, contractor, and the system manager. The review of records once retrieved is limited to the employee, supervisor, contractor, and system manager.
Records are maintained in electronic format under Forest Service file code 6500 established for General Finance and Accounting information. Access to the information is restricted to the individual employee, the contractor, and the system manager.
Director, USDA, Forest Service, Financial Management Systems, 1400 Independence Avenue, SW., Mailstop 1149, Washington, DC 20250-1149.
Individuals may request information regarding this system of records, or information as to whether the system contains records pertaining to them from the System Manager (address above). A request for information should contain name, address, and particulars involved (for example, the date of action giving rise to the inquiry or complaint).
Individuals who wish to gain access to or amend records pertaining to them should submit a written request to the System Manager (address above). The envelope should be marked “Privacy Act Request.”
Same as record access procedures.
Information in this system is collected voluntarily from individuals, who are authorized Forest Service uniform allowances, and from the individual's supervisor.
None.
The purpose of this system is to provide the U.S. Department of Agriculture's (USDA) Forest Service (FS) to maintain records that identify individuals who apply for and are approved to purchase and wear the Forest Service uniform. The Uniform Allowance System (UNAW) is managed by the Financial Management Systems Staff (FIN). FIN is a staff under the Office of the Chief Financial Officer.
The authority for maintaining this system of records is 5 U.S.C. 5901-5903.
The information gathered is voluntarily submitted by individuals who are authorized to purchase and wear a Forest Service uniform while performing official duties. The system of records consists of completed Forest Service form FS-6100-36 (Uniform Authorization), and information on uniform allowances and expenditures for authorized individuals. Information collected includes the individual's name, social security number, employee location, allowance category, job code, and current status (active or terminated).
The system provides for the following routine use disclosures that are necessary and proper for the agency's administration of its duties in connection with operating the program: disclosures in connection with litigation; for law enforcement purposes; for responses to Congressional inquiries; to the National Archives and Records Administration and the General Services Administration for records inspections; limited disclosure to entities engaged by the agency in the performance of a service; and for disclosure in connection with information security breaches in order to protect the interests of the individuals covered by the system. While these routine uses allow disclosures outside USDA, and so have some
All hard copy records are maintained in secured locked file cabinets in agency offices which are locked during non-duty hours. All electronic information is maintained in a web-based database and stored and backed-up on secured servers. Computer access to information on individuals in the system is limited to the individual, contractor, and the system manager. The review of records retrieved is limited to the individual, supervisor, approved contractors, and system manager.
A copy of the form, used to collect the information from individuals, is attached to this report. The system of records is not exempt from any provisions of the Privacy Act.
Animal and Plant Health Inspection Service, USDA.
Notice.
The Animal and Plant Health Inspection Service is soliciting letters of interest from entities subject to the regulations governing the introduction of genetically engineered (GE) organisms in 7 CFR part 340 to participate in a National Environmental Policy Act (NEPA) Pilot Project. The NEPA Pilot Project will test new approaches to developing environmental analyses and documents required under NEPA to determine the extent to which these approaches improve the quality, timeliness, and cost effectiveness of such analyses and documents. The pilot project will focus only on NEPA analyses and documents associated with petitions for nonregulated status for GE organisms.
Letters of interest may be submitted through April 8, 2013 to the person listed under
Mr. David Reinhold, Assistant Director, Environmental Risk Analysis Programs, BRS, APHIS, 4700 River Road Unit 146, Riverdale, MD 20737-1238; (301) 734-0660;
The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered “regulated articles.” The regulations in § 340.6(a) provide that any person may submit a petition to the Animal and Plant Health Inspection Service (APHIS) seeking a determination that an article should not be regulated under 7 CFR part 340, also referred to as a request to grant nonregulated status or to deregulate an article.
Before APHIS determines whether an article can be deregulated, APHIS prepares a plant pest risk assessment (PPRA) to assess the plant pest risk of the article. In accordance with The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321
The regulations in § 340.6(c)(1) through (c)(5) require the petitioner to submit specific information to meet regulatory requirements and inform APHIS' evaluation of the petition. While petitioners may submit much of the necessary information, APHIS retains primary responsibility for researching and analyzing all the data necessary to prepare the environmental documents. APHIS also evaluates all comments received on the environmental documents. APHIS has, on occasion, used consultants and contractors to perform some of these functions under APHIS guidance and oversight. In APHIS' experience, the cost of a draft EA generally ranges from $60,000-$80,000, and the cost of a complete EIS can exceed $1,000,000.
To explore ways to enhance APHIS' NEPA compliance, APHIS is implementing a NEPA Pilot Project that will involve working with petitioners and outside experts to develop high-quality environmental analyses and documents in a timelier manner. This pilot project is part of a larger effort to improve the petition evaluation process and is one of the strategies identified in USDA's High Priority Performance Goal for biotechnology regulation in the President's Performance Agenda.
The pilot project will explore two voluntary mechanisms: (1) A petitioner-submitted environmental report based upon which APHIS would develop an EA or an EIS; and (2) an EA or EIS prepared by a contractor, funded by a cooperative services agreement between the petitioner and APHIS.
The petitioner-submitted environmental reports should contain information necessary to develop a draft EA or EIS, including, for example, a description of the geographic area that will be affected and potential impacts on the environment, such as effects on water quality and sensitive wildlife species.
Under the contractor-prepared EA or EIS alternative, petitioners will provide funds for the environmental analyses and documents, while APHIS will select and direct the contractor. In addition, with this alternative, analyses and documents may be prepared for the entire NEPA process or only part of the process,
APHIS will independently evaluate all information and references in the environmental documents, supplement the information and analysis in the environmental reports as necessary, and make its own evaluation of the environmental issues and the adequacy of the analyses of those issues to ensure that the scope and content of the environmental analyses meet all requirements of CEQ's regulations and APHIS' NEPA implementing regulations (7 CFR part 372).
NEPA compliance is an important Agency responsibility, and the pilot project is designed and intended to
APHIS will evaluate the overall results of the pilot project, including the effectiveness of using environmental analyses and documents prepared by petitioners (environmental reports) as compared to environmental analyses and documents prepared using an independent contractor (EAs and EISs), and a cost analysis of the two approaches in relationship to the quality and timeliness of the final product.
APHIS is soliciting letters of interest from regulated entities interested in participating in the NEPA Pilot Project; no limit has been set on the number of participants. APHIS anticipates that the pilot project will run for 2 years. However, APHIS is interested in advancing the pilot project in the next few months and therefore encourages interested entities to submit letters of interest as soon as possible. Interested entities may submit letters of interest by mail or e-mail through April 8, 2013 to the person listed under
7 U.S.C. 7701-7772 and 7781-7786; 31 U.S.C. 9701; 7 CFR 2.22, 2.80, and 371.3.
Farm Service Agency, USDA.
Notice; request for comments.
In accordance with the Paperwork Reduction Act of 1995, the Farm Service Agency (FSA) is seeking comments from all interested individuals and organizations on an extension of a currently approved information collection that supports the Certified State Mediation Program. The information collection is necessary to ensure the grant program is being administered properly. The collection of information by mail, phone, fax, in person, and by the internet is utilized by FSA initially to determine whether the State meets the eligibility criteria to be a recipient of grant funds. Lack of adequate information to make these determinations could result in the improper administration and appropriation of Federal grant funds.
We will consider comments that we receive by June 6, 2011.
We invite you to submit comments on this notice. In your comments, include date, volume, and page number of this issue of the
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•
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You may also send comments to the Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget, Washington, DC 20503. Copies of the information collection may be requested by contacting Carol Wagner at the above addresses.
Carol Wagner, FSA, Appeals and Litigation Staff, telephone (202) 720-4966.
The information to be collected includes an application for certification, re-verification for subsequent annual approval, SF-424, SF-424A, and SF-424B Application for Federal Assistance, financial management systems and reporting requirements, and audit reports. The information collection request has not changed since the last OMB approval.
The information requested is reported annually and is necessary for the FSA to determine eligibility and administer the mediation grant program in an equitable and cost-effective manner.
We are requesting comments on all aspects of this information collection to help us to:
(1) Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2) Evaluate the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility and clarity of the information to be collected;
(4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
All comments in response to this notice, including names and addresses when provided, will be a matter of public record. Comments will be summarized and included in the request for OMB approval.
Food Safety and Inspection Service, USDA; Food and Drug Administration, HHS.
Notice; request for comments and for scientific data and information.
The Food Safety and Inspection Service (FSIS) and the Food and Drug Administration (FDA) are requesting comments and scientific data and information that would assist the agencies in their plan to update a risk assessment on the relationship between foodborne
Submit electronic or written comments and scientific data and information by July 6, 2011.
In 2003, FDA and FSIS published a quantitative assessment of the relative risk to public health from foodborne
Since publication of the 2003 risk assessment, the food industry has changed some practices, including by adding growth inhibitors to RTE products.
Risk assessments can be used to evaluate potential risk mitigation strategies and can guide, support, and enhance an Agency's risk management policies, outreach efforts, data collection initiatives, and research priorities. To help ensure that risk mitigation strategies, risk management policies, outreach efforts, data collection initiatives, and research priorities aimed at controlling
FSIS and FDA are requesting technical comments on the approach outlined previously for updating the 2003 risk assessment. FDA and FSIS are also requesting the submission of new data and information relevant to this risk assessment that was not available for inclusion in the previous risk assessment and that may reflect changes in
The agencies specifically request new data and information concerning, but not limited to, the following factors that may affect the relative risk of listeriosis associated with consumption of the types of RTE foods that were considered in the 2003 risk assessment:
1.
• The frequency of detecting the presence of
• The number of
2.
• Data or models on survival and growth of
• Data or models on survival and growth of
• Data or models on survival and growth of
3. The relationship between the dose of
• The effect of age, health status, or other characteristics of the consumer on the dose-response relationship;
• The effect of food matrix and product formulation on the dose-response relationship;
• The effect of genetic characteristics of the
• Any other data pertinent to
4. Current food consumption practices in the United States, including:
• The frequency with which different RTE foods (
• Serving sizes for different RTE foods.
5. Food production practices in the United States that may impact
• The absolute or relative frequency of manufacturing different RTE foods with substances that inhibit the growth of
• The absolute or relative amount of specific types of RTE foods that are prepared, sliced, cut, or repackaged in retail operations as opposed to being sold pre-sliced/pre-cut;
• The absolute or relative amount of different RTE foods manufactured without growth inhibitors that are prepared, sliced, or repackaged at retail;
• The average shelf life of foods that were identified in the 2003 risk assessment (Ref. 4) as supporting
• The average shelf life of RTE foods that were not explicitly identified in the 2003 risk assessment but that may conceivably support
• The ability of current production practices to prevent or reduce
• The ability of current operational practices in retail operations to prevent or reduce
• The ability of current post-processing practices to prevent
6. Storage times and temperatures that may affect
7. Other comments, including the RTE food categories that should be evaluated in the risk assessment.
The following references are on display in the Division of Dockets Management (
1. U.S. Department of Health and Human Services, “Healthy People 2010,” Chapter 10, Food Safety, Washington, DC, 2000,
2. U.S. Department of Health and Human Services, “Healthy People 2020,” HP 2020 Framework, Washington, DC, 2010, available at
3. Anonymous, 2010, “Preliminary FoodNet Data on the Incidence of Infection With Pathogens Transmitted Commonly Through Food—10 States, 2009,”
4. U.S. Department of Health and Human Services, “Healthy People 2020,” HP 2020 FS-1.3, Washington, DC, 2010, available at
5. U.S. Department of Health and Human Services and U.S. Department of Agriculture/Food Safety and Inspection Service, “Quantitative Assessment of Relative Risk to Public Health From Foodborne
6. Endrikat, S., D. Gallagher, R. Pouillot, H. Hicks Quesenberry, D. Labarre, C. M. Schroeder, and J. Kause, “A Comparative Risk Assessment for
7. U.S. Department of Agriculture, Food Safety and Inspection Service, 2003, 9 CFR part 430, “Control of
8. U.S. Department of Agriculture/Food Safety and Inspection Service, “The FSIS Microbiological Testing Program for Ready-to-Eat (RTE) Meat and Poultry Products, 1990-2009,” September 2010, available at
Forest Service, USDA.
Notice of intent to prepare an environmental impact statement.
The Forest Service will prepare an environmental impact statement (EIS) to document the analysis and disclose the environmental impacts of proposed land management activities and corresponding alternatives within the Lakewood Southeast Project. The purpose of the Lakewood Southeast Project is to implement land management activities that are consistent with direction in the Chequamegon-Nicolet National Forest 2004 Land and Resource Management Plan and respond to the specific needs identified in the project area. The project-specific needs include: Reintroduction of natural regimes, wildlife habitat and stream bank improvement, forest age, forest composition, and stocking.
Comments concerning the scope of the analysis must be received by May 9, 2011 in order to be useful in preparation of the draft statement. The draft environmental impact statement is expected in May 2011 and the final environmental impact statement is expected August 2011.
Send written comments concerning this proposal to Marilee Houtler,
Marilee Houtler, NEPA Coordinator at the above address or by phone at 715-276-6333.
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Time, Monday through Friday.
The information presented in this notice is included to help the reviewer determine if they are interested in or potentially affected by the proposed land management activities. The information presented in this notice is summarized. Those who wish to provide comments, or are otherwise interested in or affected by the project, are encouraged to obtain additional information from the contact listed above.
The current conditions of many forest stands in the project area vary from desired conditions in the Chequamegon-Nicolet National Forest 2004 Land and Resource Management Plan (forest plan). Our information shows some of the more notable gaps between the existing and desired future conditions by management area. Of primary importance is the need for change in: (1) Loss of natural regimes (2) wildlife habitat (3) stream improvement (4) species age structure (5) species composition and (6) stocking densities. The dominant habitat in the Lakewood Southeast Project area is upland conifer forests mixed with other forest communities.
Preliminary analysis of the project area indicates that there are certain conditions that warrant action to accomplish the direction and desired conditions identified in the forest plan.
Projected project implementation would be spring of 2012. Lakewood Southeast Project is located on National Forest System lands, administered by the Lakewood-Laona Ranger District, east of Mountain, WI. The legal description of the project is Township 31-32 North, Range 17 East. The Forest Service proposes to reintroduce natural regimes in the Northern dry forests and Pine Barrens (mainly fire), improve wildlife habitat (manage openings, improve habitat for Regional Forester Sensitive Species) and stream corridors (adding long lived species), and use timber harvest (selection, clearcut, shelterwood, and thinning) to move toward desired conditions in the forest plan.
The responsible official for this project is Lakewood-Laona District Ranger, Chequamegon-Nicolet National Forest.
Decision making will be limited to specific activities relating to the proposed actions. The primary decision to be made will be whether or not to implement the proposed action, no action, another action alternative, or parts of alternatives that respond to the project's purpose and need. This decision would be documented in a record of decision.
This notice of intent initiates the scoping process, which guides the development of the EIS. The 45-day comment period will start after the publication in the
Forest Service, USDA.
Notice of meeting.
The Hood/Willamette Resource Advisory Committee will meet in Salem, Oregon. The committee is meeting as authorized under the Secure Rural Schools and Community Self-Determination Act (Pub. L. 110-343) and in compliance with the Federal Advisory Committee Act. The purpose of the meeting is to make recommendations for the 2012 projects.
The meeting will be held on May 16, 2011, and begin at 9:30 a.m.
The meeting will be held at the Salem Office of the Bureau of Land Management Office; 1717 Fabry Road SE; Salem, Oregon; (503) 375-5646. Written comments should be sent to Connie Athman, Mt. Hood National Forest, 16400 Champion Way, Sandy, Oregon 97055. Comments may also be sent via e-mail to
All comments, including names and addresses when provided, are placed in the record and are available for public inspection and copying. The public may inspect comments received at Mt. Hood National Forest, 16400 Champion Way, Sandy, Oregon 97055.
Connie Athman, Designated Federal Official, Mt. Hood National Forest, 16400 Champion Way, Sandy, Oregon 97055; (503) 668-1672; E-mail:
Individuals who use telecommunication devices for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339 between 8 a.m. and 8 p.m., Eastern Standard Time, Monday through Friday.
The meeting is open to the public. The following business will be conducted: (1) Recommendations on 2012 Projects; and (2) Public Forum.
The Public Forum is tentatively scheduled to begin at 9:45 a.m. Time allotted for individual presentations will be limited to 4-5 minutes. Written comments are encouraged, particularly if the material cannot be presented within the time limits for the Public Forum. Written comments may be submitted prior to the May 16th meeting by sending them to the Designated Federal Official, Connie Athman at the address given above.
An application has been submitted to the Foreign-Trade Zones (FTZ) Board (the Board) by the Board of Harbor Commissioners of the Oxnard Harbor District, grantee of FTZ 205, requesting authority to reorganize the zone under the alternative site framework (ASF) adopted by the Board (74 FR 1170, 1/12/09 (correction 74 FR 3987, 1/22/09); 75 FR 71069-71070, 11/22/10). The ASF is an option for grantees for the establishment or reorganization of general-purpose zones and can permit significantly greater flexibility in the designation of new “usage-driven” FTZ sites for operators/users located within a grantee's “service area” in the context of the Board's standard 2,000-acre activation limit for a general-purpose zone project. The application was submitted pursuant to the Foreign-Trade Zones Act, as amended (19 U.S.C. 81-81u), and the regulations of the Board (15 CFR part 400). It was formally filed on March 31, 2011.
FTZ 205 was approved by the Board on October 28, 1994 (Board Order 714, 59 FR 55420, 11/07/1994) and expanded on April 28, 1998 (Board Order 978, 63 FR 25819, 05/11/1998).
The current zone project includes the following sites:
The grantee's proposed service area under the ASF would be Ventura County, California, as described in the application. If approved, the grantee would be able to serve sites throughout the service area based on companies' needs for FTZ designation. The proposed service area is within and adjacent to the Port Hueneme Customs and Border Protection port of entry.
The applicant is requesting authority to reorganize its existing zone project to include all of the existing sites as “magnet” sites. No usage-driven sites are being requested at this time. Because the ASF only pertains to establishing or reorganizing a general-purpose zone, the application would have no impact on FTZ 205's authorized subzone.
In accordance with the Board's regulations, Christopher Kemp of the FTZ Staff is designated examiner to evaluate and analyze the facts and information presented in the application and case record and to report findings and recommendations to the Board.
Public comment is invited from interested parties. Submissions (original and 3 copies) shall be addressed to the Board's Executive Secretary at the address below. The closing period for their receipt is June 6, 2011. Rebuttal comments in response to material submitted during the foregoing period may be submitted during the subsequent 15-day period to June 21, 2011.
A copy of the application will be available for public inspection at the Office of the Executive Secretary, Foreign-Trade Zones Board, Room 2111, U.S. Department of Commerce, 1401 Constitution Avenue, NW., Washington, DC 20230-0002, and in the “Reading Room” section of the Board's Web site, which is accessible via
Import Administration, International Trade Administration, Department of Commerce.
In response to a request by the petitioners and two producers/exporters of the subject merchandise, the Department of Commerce (the Department) is conducting an administrative review of the antidumping duty order on certain orange juice (OJ) from Brazil with respect to four producers/exporters of the subject merchandise to the United States. This is the fourth period of review (POR), covering March 1, 2009, through February 28, 2010.
We have preliminarily determined that sales to the United States have been made below normal value (NV), and, therefore, are subject to antidumping duties. If these preliminary results are adopted in the final results of this review, we will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries.
Hector Rodriguez or Blaine Wiltse, AD/CVD Operations, Office 2, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230;
In March 2006, the Department published in the
In accordance with 19 CFR 351.213(b)(2), in March 2010, the Department received requests to conduct an administrative review of the antidumping duty order on OJ from Brazil from two producers/exporters of the subject merchandise, Fischer S.A. Comercio, Industria, and Agricultura (Fischer) and Sucocitrico Cutrale, S.A. (Cutrale). In Cutrale's request for an administrative review, it also requested revocation of the antidumping duty order with respect to its sales of subject merchandise, pursuant to 19 CFR 351.222(b).
In accordance with 19 CFR 351.213(b)(1), also in March 2010, the petitioners (Florida Citrus Mutual, A. Duda & Sons, Citrus World Inc., and Southern Gardens Citrus Processing Corporation), also requested that the Department conduct an administrative review for Cutrale and Fischer, as well as for two additional producers/exporters: Montecitrus Trading S.A. (Montecitrus) and Coinbra-Frutesp (SA) (Coinbra-Frutesp). In April 2010, the Department initiated an administrative review for all four companies.
In May 2010, we received statements from Coinbra-Frutesp and Montecitrus that they had no shipments of subject merchandise to the United States during the POR.
From May through July 2010, we received responses to section A of the questionnaire (
From August through November 2010, we issued supplemental sales and cost questionnaires to Cutrale and Fischer. We received responses to these supplemental questionnaires from September through November 2010.
On November 16, 2010, the Department extended the deadline for the preliminary results of this review until no later than March 31, 2010.
From December 2010 through March 2011, we issued Cutrale and Fischer additional supplemental sales and cost questionnaires. We received responses to these supplemental questionnaires from January through March 2011.
Finally, in March 2011, we requested that Cutrale provide additional information regarding its indirect selling expenses. Because this information was not received in time for use in the preliminary results, we expect to consider this information in the final results.
The scope of this order includes certain orange juice for transport and/or further manufacturing, produced in two different forms: (1) Frozen orange juice in a highly concentrated form, sometimes referred to as frozen concentrated orange juice for manufacture (FCOJM); and (2) pasteurized single-strength orange juice which has not been concentrated, referred to as not-from-concentrate (NFC). At the time of the filing of the petition, there was an existing antidumping duty order on frozen concentrated orange juice (FCOJ) from Brazil.
Excluded from the scope of the order are reconstituted orange juice and frozen concentrated orange juice for retail (FCOJR). Reconstituted orange juice is produced through further manufacture of FCOJM, by adding
The subject merchandise is currently classifiable under subheadings 2009.11.00, 2009.12.25, 2009.12.45, and 2009.19.00 of the Harmonized Tariff Schedule of the United States (HTSUS). These HTSUS subheadings are provided for convenience and for customs purposes only and are not dispositive. Rather, the written description of the scope of the order is dispositive.
The Department may revoke, in whole or in part, an antidumping duty order upon completion of a review under section 751 of the Tariff Act of 1930, as amended (the Act). While Congress has not specified the procedures that the Department must follow in revoking an order, the Department has developed a procedure for revocation that is described in 19 CFR 351.222. This regulation requires,
On March 31, 2010, Cutrale requested revocation of the antidumping duty order with respect to its sales of subject merchandise, pursuant to 19 CFR 351.222(b). This request was accompanied by certification that: (1) Cutrale sold the subject merchandise at not less than NV during the current POR and will not sell the merchandise at less than NV in the future; and (2) it sold subject merchandise to the United States in commercial quantities for a period of at least three consecutive years. Cutrale also agreed to immediate reinstatement of the antidumping duty order, as long as any exporter or producer is subject to the order, if the Department concludes that, subsequent to the revocation, it sold the subject merchandise at less than NV.
In its revocation request, filed in this fourth administrative review, Cutrale argued that the Department found dumping margins below
After analyzing Cutrale's request for revocation, we preliminarily find that it does not meet all of the criteria under 19 CFR 351.222(b). Pursuant to the regulation, upon receipt of a request for revocation, the Department will consider: (1) Whether the company in question has sold subject merchandise at not less than NV for a period of at least three consecutive years; (2) whether the company has agreed in writing to its immediate reinstatement in the order, as long as any exporter or producer is subject to the order, if the Department concludes that the company, subsequent to the revocation, sold the subject merchandise at less than NV; and (3) whether the continued application of the antidumping duty order is otherwise necessary to offset dumping.
In this case, our preliminary margin calculation for the fourth administrative review shows that Cutrale did not sell the subject merchandise at less than NV during the current review period.
Cutrale's speculation as to what antidumping margins might have been calculated in prior reviews had the Department used a different methodology does not provide a basis for revocation. The principles of administrative finality apply to these completed reviews. Cutrale did not successfully challenge the final results of the second administrative review in court and, thus, they are final and conclusive. Although Cutrale has challenged the final results of the third administrative review before the Court of International Trade, unless or until there is a final and conclusive court decision invalidating these results, by statute, these results are presumed to be correct.
With respect to Cutrale's argument that Brazil has challenged zeroing before the WTO, we acknowledge that there is an ongoing WTO dispute between Brazil and the United States regarding zeroing. However, this dispute is yet to be resolved by the WTO, including any potential appeals. More importantly, WTO reports do not provide an independent basis for altering the Department's methodology, except to the extent that they are implemented pursuant to a specified statutory scheme.
Therefore, we preliminarily determine that Cutrale does not qualify for revocation of the order on OJ pursuant to 19 CFR 351.222(b)(2), and thus, that the order with respect to such merchandise should not be revoked.
As noted in the “Background” section above, Coinbra-Frutesp and Montecitrus indicated that they had no shipments of subject merchandise to the United States during the POR. The Department subsequently confirmed with CBP the no-shipment claim made by these two companies. Because the evidence on the record indicates that these companies did not export subject merchandise to the United States during the POR, we preliminarily determine that neither Coinbra-Frutesp nor Montecitrus had any reviewable transactions during the POR.
Since the implementation of the 1997 regulations, our practice concerning no-shipment respondents has been to rescind the administrative review if the respondent certifies that it had no shipments and we have confirmed through our examination of CBP data that there were no shipments of subject merchandise during the POR.
In our May 6, 2003, “automatic assessment” clarification, we explained that, where respondents in an administrative review demonstrate that they had no knowledge of sales through resellers to the United States, we would instruct CBP to liquidate such entries at the all-others rate applicable to the proceeding.
Because “as entered” liquidation instructions do not alleviate the concerns which the May 2003 clarification was intended to address, we find it appropriate in this case to instruct CBP to liquidate any existing entries of merchandise produced by Coinbra-Frutesp or Montecitrus, and exported by other parties, at the all-others rate.
To determine whether sales of OJ by Cutrale and Fischer to the United States were made at less than NV, we compared constructed export price (CEP) to the NV, as described in the “Constructed Export Price” and “Normal Value” sections of this notice.
Pursuant to section 777A(d)(2) of the Act, we compared the CEPs of individual U.S. transactions to the weighted-average NV of the foreign like product where there were sales made in the ordinary course of trade, as discussed in the “Cost of Production Analysis” section below.
In accordance with section 771(16) of the Act, we considered all products produced by Cutrale and Fischer covered by the description in the “Scope of the Order” section, above, to be foreign like products for purposes of determining appropriate product comparisons to U.S. sales. Pursuant to 19 CFR 351.414(e)(2), we compared U.S. sales of OJ to sales of OJ in the home market within the contemporaneous window period, which extends from three months prior to the month of the first U.S. sale until two months after the last U.S. sale. Where there were no sales of identical merchandise in the home market made in the ordinary course of trade to compare to U.S. sales, we compared U.S. sales to sales of the most similar foreign like product made in the ordinary course of trade. In making product comparisons, we matched foreign like products based on the physical characteristics reported by the respondents in the following order of importance: Product type and organic designation. Where there were no sales of identical or similar merchandise, we made product comparisons using CV, as discussed in the “Calculation of Normal Value Based on Constructed Value” section below.
In accordance with section 772(b) of the Act, we calculated CEP for those sales where the merchandise was first sold (or agreed to be sold) in the United States before or after the date of importation by or for the account of the producer or exporter, or by a seller affiliated with the producer or exporter, to a purchaser not affiliated with the producer or exporter. In this case, we are treating all of Cutrale's and Fischer's U.S. sales as CEP sales because they were made in the United States by their U.S. affiliates on behalf of the respondents, within the meaning of section 772(b) of the Act.
We based CEP on the packed delivered prices to unaffiliated purchasers in the United States. For sales made pursuant to futures contracts, we adjusted the reported gross unit price (
In addition, we made deductions for movement expenses, in accordance with section 772(c)(2)(A) of the Act. These included, where appropriate, foreign inland freight; foreign warehousing expenses; foreign brokerage and handling expenses; ocean freight; U.S. brokerage and handling (offset by customer-specific reimbursements); U.S. customs duties, harbor maintenance fees and merchandise processing fees (offset by U.S. duty drawback and customs duty reimbursements); U.S. inland freight expenses; and U.S. warehousing expenses. We capped reimbursements for brokerage and handling expenses by the amount of brokerage and handling expenses incurred on the subject
In accordance with section 772(d)(1) of the Act and 19 CFR 351.402(b), we deducted those selling expenses associated with economic activities occurring in the United States, including direct selling expenses (
Pursuant to section 772(d)(3) of the Act, we further reduced the starting price by an amount for profit to arrive at CEP. In accordance with section 772(f) of the Act, we calculated the CEP profit rate using the expenses incurred by Cutrale and its U.S. affiliate on their sales of the subject merchandise in the United States and the profit associated with those sales.
For further discussion of the changes made to Cutrale's reported U.S. sales data, see the March 31, 2011, memorandum from Blaine Wiltse, Analyst, to the File, entitled “Calculation Adjustments for Sucocitrico Cutrale Ltda. for the Preliminary Results” (Cutrale Sales Calculation Memo).
We based CEP on the packed delivered prices to unaffiliated purchasers in the United States. In addition, we made deductions for movement expenses, in accordance with section 772(c)(2)(A) of the Act; these included, where appropriate, foreign inland freight expenses; foreign warehousing expenses; foreign brokerage and handling expenses; ocean freight expenses; marine insurance expenses; U.S. brokerage and handling expenses; U.S. customs duties, harbor maintenance fees and merchandise processing fees (offset by U.S. duty drawback); U.S. inland freight expenses; and U.S. warehousing expenses. We capped reimbursements for U.S. customs duties, as well as U.S. duty drawback, by the amount of U.S. customs duties incurred on the subject merchandise, in accordance with our practice.
In accordance with sections 772(d)(1) of the Act and 19 CFR 351.402(b), we deducted those selling expenses associated with economic activities occurring in the United States, including direct selling expenses (
Pursuant to section 772(d)(3) of the Act, we further reduced the starting price by an amount for profit to arrive at CEP. In accordance with section 772(f) of the Act, we calculated the CEP profit rate using the expenses incurred by Fischer and its U.S. affiliate on their sales of the subject merchandise in the United States and the profit associated with those sales.
In order to determine whether there was a sufficient volume of sales in the home market to serve as a viable basis for calculating NV, we compared the volume of home market sales of the foreign like product to the volume of U.S. sales of the subject merchandise, in accordance with section 773(a)(1)(C) of the Act.
We determined that the aggregate volume of home market sales of the foreign like product for each respondent was sufficient to permit a proper comparison with its U.S. sales of the subject merchandise.
Section 773(a)(1)(B)(i) of the Act states that, to the extent practicable, the Department will calculate NV based on sales at the same level of trade (LOT) as the export price (EP) or CEP. Sales are made at different LOTs if they are made at different marketing stages (or their equivalent).
Pursuant to section 773(a)(1)(B)(i) of the Act, in identifying LOTs for EP and comparison market sales (
When the Department is unable to match U.S. sales of the foreign like product in the comparison market at the same LOT as the EP or CEP, the Department may compare the U.S. sale to sales at a different LOT in the comparison market. In comparing EP or CEP sales at a different LOT in the comparison market, where available data make it practicable, we make an
In this administrative review, we obtained information from each respondent regarding the marketing stages involved in making the reported home market and U.S. sales, including a description of the selling activities performed by each respondent for each channel of distribution. Company-specific LOT findings are summarized below.
Cutrale reported that it made CEP sales through one channel of distribution in the United States (
Selling activities can be generally grouped into four selling function categories for analysis: (1) Sales and marketing; (2) freight and delivery; (3) inventory maintenance and warehousing; and (4) warranty and technical support.
With respect to the home market, Cutrale reported that it made sales through one channel of distribution (
Finally, we compared the CEP LOT to the home market LOT and found that the selling functions performed for U.S. and home market customers do not differ significantly. Specifically, we found that the differences were limited to the following activities: (1) Cutrale performed limited advertising in the home market (
According to 19 CFR 351.412(c)(2), the Department will determine that sales are made at different levels of trade if they are made at different marketing stages (or their equivalent). Substantial differences in selling activities are a necessary, but not sufficient, condition for determining that there is a difference in the stage of marketing. Therefore, because we determine that substantial differences in Cutrale's selling activities do not exist across markets, we determine that sales to the U.S. and home markets during the POR were made at the same LOT. As a result, neither a LOT adjustment nor a CEP offset is warranted for Cutrale. This determination is consistent with findings in previous reviews.
Fischer reported that it made CEP sales through one channel of distribution in the United States (
With respect to the home market, Fischer reported that it made sales through one channel of distribution and that the selling activities it performed did not vary by the type of customer. We examined the selling activities performed for home market sales, and found that Fischer performed the following selling functions: customer contact and price negotiation; order processing; arranging for freight; cold storage and inventory maintenance; sales and marketing support; and technical assistance. Accordingly, based on the selling function categories listed above, we find that Fischer performed sales and marketing, freight and delivery services, inventory maintenance and warehousing, and
Finally, we compared the CEP LOT to the home market LOT and found that the selling functions performed for U.S. and home market customers do not differ significantly. Therefore, we determine that sales to the U.S. and home markets during the POR were made at the same LOT, and as a result, neither a LOT adjustment nor a CEP offset is warranted for Fischer.
During the POR, Cutrale made sales in the home market to an affiliated party, as defined in section 771(33) of the Act. Consequently, we tested these sales to ensure that they were made at arm's-length prices, in accordance with 19 CFR 351.403(c). To test whether the sales to the affiliate were made at arm's-length prices, we compared the unit prices of sales to the affiliated and unaffiliated customers net of all movement charges, direct selling expenses, and packing expenses. Pursuant to 19 CFR 351.403(c) and in accordance with the Department's practice, where the price to that affiliated party was, on average, within a range of 98 to 102 percent of the price of the same or comparable merchandise sold to the unaffiliated parties at the same LOT, we determined that the sales made to the affiliated party were at arm's-length.
We found that both Cutrale and Fischer made sales below the COP in the 2007-2008 administrative review, the most recently completed segment of this proceeding as of the date of initiation of this review, and such sales were disregarded.
In accordance with section 773(b)(3) of the Act, we calculated the respondents' COPs based on the sum of their costs of materials and conversion for the foreign like product, plus amounts for general and administrative (G&A) expenses and interest expenses (
The Department relied on the COP data submitted by each respondent in its most recently submitted cost database for the COP calculation, except in the following instances:
i. We used Cutrale's home market actual brix level data to adjust Cutrale's home market costs to ensure that these are stated on a pounds-solid basis using actual brix. For further discussion of this adjustment, see the Cutrale Sales Calculation Memo.
ii. We adjusted Cutrale's financial expense ratio by limiting the interest income offset to income earned on short-term investments of its working capital. For further discussion of this adjustment, see the March 31, 2011, Memorandum from Gary Urso, Accountant, to Neal M. Halper, Director Office of Accounting, entitled “Cost of Production and Constructed Value Calculation Adjustments for the Preliminary Results—Sucocitrico Cutrale Ltda.”
i. We revised Fischer's reported per-unit raw material costs to reflect the POR cost of purchases and purchase price adjustments as recorded in Fischer's normal books and records.
ii. We revised Fischer's G&A calculation to include losses on the disposition of fixed assets and the eradication of orange trees.
For further discussion of these adjustments, see the March 31, 2011, Memorandum from Frederick Mines, Accountant, to Neal M. Halper, Director Office of Accounting, entitled “Cost of Production and Constructed Value Calculation Adjustments for the Preliminary Results—Fischer S.A. Comercio, Industria and Agricultura.”
On a product-specific basis, we compared the adjusted weighted-average COP to the home market sales prices of the foreign like product, as required under section 773(b) of the Act, in order to determine whether the sales prices were below the COP. For purposes of this comparison, we used COP exclusive of selling and packing expenses. The prices (inclusive of billing adjustments, where appropriate) were exclusive of any applicable movement charges, direct and indirect selling expenses and packing expenses.
In determining whether to disregard home market sales made at prices below the COP, we examined, in accordance with sections 773(b)(1)(A) and (B) of the Act: (1) Whether, within an extended period of time, such sales were made in substantial quantities; and (2) whether such sales were made at prices which permitted the recovery of all costs within a reasonable period of time in the normal course of trade. Where less than 20 percent of the respondent's home market sales of a given product are at prices less than the COP, we do not disregard any below-cost sales of that product, because we determine that in such instances the below-cost sales were not made within an extended period of time and in “substantial quantities.” Where 20 percent or more of a respondent's sales of a given product are at prices less than the COP, we disregard the below-cost sales when: (1) They were made within an extended period of time in “substantial quantities,” in accordance with sections 773(b)(2)(B) and (C) of the Act, and 2) based on our comparison of prices to the weighted-average COPs for the POR, they were at prices which would not permit the recovery of all costs within a reasonable period of time, in accordance with section 773(b)(2)(D) of the Act.
We found that, for certain products, more than 20 percent of Cutrale's and Fischer's home market sales were at prices less than the COP and, in addition, such sales did not provide for the recovery of costs within a reasonable period of time. We therefore excluded these sales from our analysis. We used the remaining sales as the basis for determining NV for Cutrale and Fischer in accordance with section 773(b)(1) of the Act.
For Cutrale, we calculated NV based on ex-factory prices to unaffiliated customers. We made adjustments, where appropriate, to the starting price for billing adjustments, in accordance
In addition we made deductions pursuant to section 773(a)(6)(C) of the Act for home market credit expenses (offset by interest revenue). We recalculated Cutrale's home market credit expenses to base the calculation on the gross unit price net of taxes and billing adjustments. Where applicable, in accordance with 19 CFR 351.410(e), we offset any commission paid on a U.S. sale by reducing the NV by the amount of home market indirect selling expenses and inventory carrying costs, up to the amount of the U.S. commission. We capped Cutrale's interest revenue by the amount of credit expenses, in accordance with our practice.
We deducted home market packing costs and added U.S. packing costs, where appropriate, in accordance with sections 773(a)(6)(A) and (B) of the Act.
Finally, we made adjustments for differences in costs attributable to differences in the physical characteristics of the merchandise, in accordance with section 773(a)(6)(C)(ii) of the Act and 19 CFR 351.411.
We calculated NV based on delivered prices to unaffiliated customers. We made adjustments, where appropriate, to the starting price for billing adjustments and other discounts in accordance with 19 CFR 351.401(c). We also made adjustments, where appropriate, to the starting price for Brazilian taxes, in accordance with section 773(a)(6)(B)(iii) of the Act. We made deductions for foreign inland freight expenses and inland insurance expenses, in accordance with section 773(a)(6)(B)(ii) of the Act.
In addition, we made deductions pursuant to section 773(a)(6)(C) of the Act for home market credit expenses (offset by interest revenue). We capped Fischer's interest revenue by the amount of credit expenses, in accordance with our practice.
We deducted home market packing costs and added U.S. packing costs, in accordance with sections 773(a)(6)(A) and (B) of the Act.
Finally, we made adjustments for differences in costs attributable to differences in the physical characteristics of the merchandise, in accordance with section 773(a)(6)(C)(ii) of the Act and 19 CFR 351.411.
Section 773(a)(4) of the Act provides that where NV cannot be based on comparison market sales, NV may be based on CV. Accordingly, for those OJ products for which we could not determine the NV based on comparison-market sales, either because there were no useable sales of a comparable product or all sales of the comparable products failed the COP test, we based NV on CV.
Section 773(e) of the Act provides that CV shall be based on the sum of the cost of materials and fabrication for the imported merchandise, plus amounts for SG&A expenses, profit, and U.S. packing costs. We calculated the cost of materials and fabrication based on the methodology described in the “Calculation of Cost of Production” section, above. We based SG&A and profit for Fischer on the actual amounts incurred and realized by the respondents in connection with the production and sale of the foreign like product in the ordinary course of trade for consumption in the home market, in accordance with section 773(e)(2)(A) of the Act.
For comparisons to CEP, we deducted home market direct selling expenses from CV.
We made currency conversions into U.S. dollars, in accordance with section 773A of the Act and 19 CFR 351.415, based on the exchange rates in effect on the dates of the U.S. sales as certified by the Federal Reserve Bank.
We preliminarily determine that weighted-average dumping margins exist for the respondents for the period March 1, 2009, through February 28, 2010, as follows:
The Department will disclose to parties the calculations performed in connection with these preliminary results within five days of the date of publication of this notice.
Pursuant to 19 CFR 351.310(c), interested parties who wish to request a hearing, or to participate if one is requested, must submit a written request to the Assistant Secretary for Import Administration, Room 1870, within 30 days of the date of publication of this notice. Requests should contain: (1) The party's name, address and telephone number; (2) the number of participants; and (3) a list of issues to be discussed.
Upon completion of the administrative review, the Department shall determine, and CBP shall assess, antidumping duties on all appropriate entries, in accordance with 19 CFR 351.212. The Department will issue appropriate appraisement instructions for the companies subject to this review directly to CBP 15 days after the date of publication of the final results of this review.
We will calculate importer-specific
The Department clarified its “automatic assessment” regulation on May 6, 2003.
The following cash deposit requirements will be effective for all shipments of the subject merchandise entered, or withdrawn from warehouse, for consumption on or after the publication date of the final results of this administrative review, as provided by section 751(a)(2)(C) of the Act: (1) The cash deposit rate for each specific company listed above will be that established in the final results of this review, except if the rate is less than 0.50 percent and, therefore,
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of antidumping duties occurred and the subsequent assessment of double antidumping duties.
This administrative review and notice are published in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221.
Import Administration, International Trade Administration, Department of Commerce.
On November 12, 2010, the Department of Commerce (Department) published preliminary results for the new shipper reviews (NSRs) of fresh garlic from the People's Republic of China (PRC) covering the period of review (POR) November 1, 2008, through October 31, 2009.
As discussed below, we preliminarily found that Yuanxin's and Huachao's sales were
Scott Lindsay, AD/CVD Operations, Office 6, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-0780.
Since the
On February 4, 2011, the Department issued the briefing schedule for briefs addressing all issues except the
On February 18, 2011, the Department issued the briefing schedule for briefs addressing only the
On March 1, 2011, Huachao requested an extension to the deadline of the
On March 16, 2011, Department officials met with Chengda's counsel to discuss issues related to the case briefs.
The products covered by the order are all grades of garlic, whole or separated into constituent cloves, whether or not peeled, fresh, chilled, frozen, provisionally preserved, or packed in water or other neutral substance, but not prepared or preserved by the addition of other ingredients or heat processing. The differences between grades are based on color, size, sheathing, and level of decay. The scope of this order does not include the following: (a) garlic that has been mechanically harvested and that is primarily, but not exclusively, destined for non-fresh use; or (b) garlic that has been specially prepared and cultivated prior to planting and then harvested and otherwise prepared for use as seed. The subject merchandise is used principally as a food product and for seasoning. The subject garlic is currently classifiable under subheadings 0703.20.0010, 0703.20.0020, 0703.20.0090, 0710.80.7060, 0710.80.9750, 0711.90.6000, and 2005.90.9700 of the Harmonized Tariff Schedule of the United States (HTSUS). Although the HTSUS subheadings are provided for convenience and customs purposes, our written description of the scope of the order is dispositive. In order to be excluded from the order, garlic entered under the HTSUS subheadings listed above that is (1) mechanically harvested and primarily, but not exclusively, destined for non-fresh use or (2) specially prepared and cultivated prior to planting and then harvested and otherwise prepared for use as seed must be accompanied by declarations to CBP to that effect.
In addition to commenting on the
In conducting an NSR, the Department examines price, quantity, and other circumstances associated with the sale to determine if the sale was based on normal commercial considerations and presents an accurate representation of the company's normal business practices, and provides a future indicator of its future selling practice.
In the
For the
For the
In the
Significant portions of the issues involved in Yuanxin's
For the foregoing reasons, the Department finds that the sales of all three new shippers are not
The Department will notify U.S. Customs and Border Protection that bonding is no longer permitted to fulfill security requirements for shipments by Chengda, Huachao, and Yuanxin of fresh garlic from the PRC entered, or withdrawn from warehouse, for consumption in the United States on or after the publication of this rescission notice in the
This notice is the only reminder to parties subject to the administrative protective order (APO) of their responsibility concerning the return or destruction of proprietary information
These new shipper reviews and notice are issued and published in accordance with sections 751(a)(2)(B) and 777(i) of the Act and 19 CFR 351.214.
Import Administration, International Trade Administration, Department of Commerce.
In response to a timely request from Compass Chemical International LLC (“Petitioner”), the Department of Commerce (“Department”) is conducting an administrative review of the antidumping duty order on 1-hydroxyethylidene-1, 1-diphosphonic acid (“HEDP”) from the People's Republic of China (“PRC”). The period of review (“POR”) is April 23, 2009, through March 31, 2010. This administrative review covers two exporters of the subject merchandise that are being individually examined as mandatory respondents.
The Department has preliminarily determined that one mandatory respondent, Jiangsu Jianghai Chemical Group Co., Ltd. (“Jiangsu Jianghai”), did not demonstrate that it is entitled to a separate rate. Therefore, the Department has treated Jiangsu Jianghai as part of the PRC-wide entity. The other mandatory respondent, Changzhou Wujin Fine Chemical Factory Co., Ltd. (“Wujin Fine”), reported that it did not ship subject merchandise to the United States during the POR. Because record evidence does not contradict Wujin Fine's no-shipment claim, the Department intends to rescind the administrative review with respect to this company. If these preliminary results are adopted in the final results of review, the Department will instruct U.S. Customs and Border Protection (“CBP”) to assess antidumping duties on entries of subject merchandise during the POR for which the importer-specific assessment rates are above
Interested parties are invited to comment on these preliminary results. Parties that submit comments are requested to submit with each argument a statement of the issue and a brief summary of the argument. The Department intends to issue the final results of this review no later than 120 days from the date of publication of this notice.
Shawn Higgins, AD/CVD Operations, Office 4, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230;
On April 28, 2009, the Department published the antidumping duty order on HEDP from the PRC in the
The
On June 7, 2010, the Department issued antidumping questionnaires to Jiangsu Jianghai and Wujin Fine.
In November and December 2010, Jiangsu Jianghai submitted timely responses to Sections A, C, and D of the antidumping questionnaire.
In response to the Department's November 12, 2010, letter providing all interested parties with an opportunity to submit comments regarding surrogate country and surrogate value selection,
On December 1, 2010, the Department extended the time period for completing the preliminary results of this administrative review until March 31, 2011.
The merchandise subject to the order includes all grades of aqueous, acidic (non-neutralized) concentrations of 1-hydroxyethylidene-1, 1-diphosphonic acid,
As stated above, Jiangsu Jianghai and Wujin Fine submitted letters certifying that they did not ship subject merchandise to the United States during the POR. To test these claims, the Department ran a CBP data query, issued no-shipment inquiries to CBP requesting that it provide any information that contradicted these no-shipment claims, and obtained entry documentation from CBP. After examining this information, the Department has preliminarily determined that Jiangsu Jianghai had a shipment of subject merchandise that entered the United States during the POR.
In every case conducted by the Department involving the PRC, the PRC has been treated as a non-market economy (“NME”) country. In accordance with section 771(18)(C)(i) of the Tariff Act of 1930, as amended (the “Act”), any determination that a foreign country is an NME country shall remain in effect until revoked by the administering authority. None of the parties to this proceeding have contested NME treatment.
In proceedings involving NME countries, the Department maintains a rebuttable presumption that all companies within the country are subject to government control.
On November 19, 2010, Jiangsu Jianghai submitted its response to Section A of the antidumping questionnaire.
Moreover, by submitting incomplete and unverifiable responses to the antidumping questionnaire and not responding to either the Department's December 9, 2010, supplementary Sections A and C questionnaire or its December 17, 2010, supplementary Section D questionnaire, Jiangsu Jianghai did not meet its requirement to fully participate in this administrative review by responding to all information that has been requested by the Department.
Therefore, the Department has preliminarily determined that Jiangsu Jianghai does not qualify for a separate rate because it has failed to demonstrate an absence of
Section 776(a) of the Act provides that the Department shall apply “facts otherwise available” if: (1) Necessary information is not on the record, or (2) an interested party or any other person (A) withholds information that has been requested, (B) fails to provide information within the deadlines established, or in the form and manner requested by the Department, subject to subsections (c)(1) and (e) of section 782 of the Act, (C) significantly impedes a proceeding, or (D) provides information that cannot be verified as provided by section 782(i) of the Act.
Further, Section 776(b) of the Act provides that the Department may use an adverse inference in applying the facts otherwise available when a party has failed to cooperate by not acting to the best of its ability to comply with a request for information. Such an adverse inference may include reliance on information derived from the petition, the final determination, a previous administrative review, or other information placed on the record.
In the
As explained above, Jiangsu Jianghai, as part of the PRC-wide entity, submitted incomplete and unverifiable responses to the antidumping questionnaire and did not respond to either the Department's December 9, 2010, supplementary Sections A and C questionnaire or its December 17, 2010 supplementary Section D questionnaire. For these reasons, the Department has preliminarily determined that the PRC-wide entity (1) withheld information that was requested, (2) failed to provide information within the deadlines established and in the form and manner requested by the Department, (3) significantly impeded this proceeding, and (4) provided information that cannot be verified. Therefore, in accordance with subsections 776(a)(2)(A) through (D) of the Act, the Department has preliminarily based the dumping margin of the PRC-wide entity on the facts otherwise available. Further, because the PRC-wide entity failed to cooperate by not acting to the best of its ability to comply with the Department's requests for information, the Department has preliminarily determined, pursuant to section 776(b) of the Act, to use an inference that is adverse to the interests of the PRC-wide entity in selecting from among the facts otherwise available.
Section 776(b) of the Act and 19 CFR 351.308(c)(1) provide that the Department's adverse inference “may include reliance on information derived from (1) the petition, (2) a final determination in the investigation, (3) any previous review or determination, or (4) any other information placed on the record.” In selecting a rate for use as AFA, the Department selects a rate that is sufficiently adverse “as to effectuate the purpose of the facts available rule to induce respondents to provide the Department with complete and accurate
Section 776(c) of the Act provides that, when the Department relies on secondary information rather than on information obtained in the course of an investigation or review, it shall, to the extent practicable, corroborate that information from independent sources that are reasonably at its disposal. Secondary information is defined as information derived from the petition that gave rise to the investigation or review, the final determination concerning the subject merchandise, or any previous review under section 751 of the Act concerning the subject merchandise.
To corroborate the 72.42 percent petition rate, the Department first revisited its pre-initiation analysis of the information in the petition. During the initiation of the antidumping investigation of HEDP from the PRC, the Department examined evidence supporting the calculations in the petition and the supplemental information provided by Petitioner to determine the probative value of the margins alleged in the petition.
To further corroborate the 72.42 percent petition rate, the Department examined the information on the record of this administrative review. Because the Department has, in accordance with section 782(d) of the Act, disregarded all of Jiangsu Jianghai's responses to the antidumping questionnaire, the Department preliminarily determined that the only information on the record of this administrative review that can be used for purposes of corroboration are the entry documents provided by CBP.
For these reasons, the Department has preliminarily determined that the 72.42 percent petition rate has probative value and, therefore, is corroborated to the extent practicable, in accordance with section 776(c) of the Act. Moreover, because the information on the record of this administrative review that can be used for purposes of corroboration approximate the information used as a basis for the petition rate, the Department is satisfied that the 72.42 percent petition rate reflects commercial reality.
The Department has preliminarily determined that the following weighted-average dumping margins exist for the period April 23, 2009, through March 31, 2010:
Interested
The Department will issue the final results of this administrative review, which will include the results of its analysis of issues raised in the briefs, within 120 days of publication of these preliminary results, in accordance with 19 CFR 351.213(h)(1), unless the time limit is extended.
Pursuant to 19 CFR 351.212, the Department will determine, and CBP shall assess, antidumping duties on all appropriate entries of subject merchandise in accordance with the final results of this review. The Department intends to instruct CBP to liquidate entries containing subject merchandise exported by the PRC-wide entity at the PRC-wide rate the Department determines in the final results of this review. The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of the final results of this review.
The following cash deposit requirements will be effective upon publication of the final results of this administrative review for all shipments of the subject merchandise from the PRC entered, or withdrawn from warehouse, for consumption on or after the publication date, as provided for by section 751(a)(2)(C) of the Act: (1) For previously investigated or reviewed PRC and non-PRC exporters not listed above that have separate rates, the cash deposit rate will continue to be the exporter-specific rate published for the most recent period; (2) for all PRC exporters of subject merchandise which have not been found to be entitled to a separate rate, the cash deposit rate will be the PRC-wide rate established in the final results of this review; and (3) for all non-PRC exporters of subject merchandise which have not received their own rate, the cash deposit rate will be the rate applicable to the PRC exporters that supplied that non-PRC exporter. These deposit requirements, when imposed, shall remain in effect until further notice.
This notice also serves as a preliminary reminder to importers of their responsibility under 19 CFR 351.402(f) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary presuming that reimbursement of antidumping duties occurred and, subsequently, the assessment of double antidumping duties.
The Department is issuing and publishing these preliminary results of administrative review in accordance with sections 751(a)(1) and 777(i)(1) of the Act and 19 CFR 351.221(b)(4).
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Notice of a public meeting.
The New England Fishery Management Council (Council) will hold a 3-day meeting on Tuesday through Thursday, April 26-28, 2011, to consider actions affecting New England fisheries in the exclusive economic zone (EEZ).
The meeting will be held on Tuesday, April 26, 2011 through Thursday, April 28, 2011. The meeting will begin at 9 a.m. on Tuesday, April 26th and at 8:30 a.m. on Wednesday, April 27th and Thursday, April 28th.
The meeting will be held at the Mystic Hilton Hotel, 20 Coogan Boulevard, Mystic, CT 06355; telephone: (860) 572-0731; fax: (860) 572-0238.
Paul J. Howard, Executive Director, New England Fishery Management Council; telephone: (978) 465-0492.
Following introductions and any announcements, the Council will receive brief reports from its Chairman and Executive Director, the NOAA Fisheries Regional Administrator (Northeast Region), Northeast Fisheries Science Center and Mid-Atlantic Fishery Management Council liaisons, NOAA General Counsel, representatives of the U.S. Coast Guard and the Atlantic States Marine Fisheries Commission, as well as staff from the Vessel Monitoring Systems Operations and Law Enforcement offices. There also will be a review of any experimental fishery permit applications that have been made available for review since the January Council meeting. The Council will then receive a presentation and discuss one of its 2011 priorities, a proposed NEFMC-sponsored catch shares workshop. The discussion will include consideration and possible approval of a workshop goal and objectives. Prior to a break, Mr. Eric Schwaab, Assistant Administrator for NOAA Fisheries, will address the Council about the agency's management review of fisheries in the Northeast. The focus will be on the relationships among the NEFMC, the Northeast Regional Office, and the Northeast Fisheries Science Center and factors that affect the effectiveness of the three entities to carry out their responsibilities under fisheries law. Following a break, an open public period is scheduled for any interested party who wishes to provide brief comments on issues relevant to Council business but not otherwise listed on the meeting agenda. A representative of the Department of the Interior will summarize that agency's offshore wind initiative, including the Maine, Massachusetts, and Rhode Island Task Force efforts to date. The day will conclude on Tuesday with a report from the Council's Scientific and Statistical Committee (SSC). Items for review and discussion, along with SSC recommendations, include the following: (1) A review of the Massachusetts Fisheries Institute report
The second session will begin with a report from the Council's Research Steering Committee about several final cooperative research project reports, including the University of Rhode
The last day of the Council meeting will begin with a presentation about “management area coordination.” This will consist of an overview of the relationships between the current groundfish mortality closures and the current and proposed essential fish habitat closures, and their impact on access to fishery resources. The Council will address groundfish management for the remainder of this day. It intends to take final action on Framework Adjustment 46 to the Northeast Multispecies Fishery Management Plan (FMP), which would cap the amount of haddock the herring fleet would be allowed to take as bycatch in that fishery. The Council also may take final action on Amendment 17 to the Multispecies FMP. Amendment 17 would create a mechanism for the operation of NOAA-funded, state-operated permit banks. Other groundfish-related business items include a report on workshop planning for the purpose of examining the last year of sector operations, and a Groundfish Committee recommendation to delay further work on an amendment to consider accumulation limits in the fishery. Any other outstanding business will be discussed after the groundfish agenda items have been completed.
Although other non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subjects of formal action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305(c) of the Magnuson-Stevens Act, provided that the public has been notified of the Council's intent to take final action to address the emergency.
This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Paul J. Howard (
Commodity Futures Trading Commission.
Notice; publication of existence and character of a new system of records.
The Commodity Futures Trading Commission is establishing a system of records under the Privacy Act of 1974 for the online collection of public comments to notices of proposed rulemakings, proposed orders, and other regulatory actions that are required to be published in the
Comments should be postmarked by May 17, 2011. This notice will become effective without further notice, on the date which is 60 days from the date given above unless otherwise revised pursuant to comments received.
You may submit comments, identified by “Comments Online SORN,” by any of the following methods:
• Agency Web site, via its Comments Online process:
• Federal eRulemaking Portal: Comments may be submitted at
• Mail: David A. Stawick, Secretary of the Commission, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581.
• Hand Delivery/Courier: Same as mail above.
All comments must be submitted in English, or if not, accompanied by an English translation. Comments will be posted as received to
The Commission reserves the right, but shall have no obligation, to review, pre-screen, filter, redact, refuse or remove any or all of a submission from
Kathy Harman-Stokes, Chief Privacy Officer,
The CFTC is obligated to collect comments on rulemakings and other regulatory action, which it timely publishes on its Web site to provide transparency in the informal rulemaking process under the Administrative Procedure Act (“APA”), 5 U.S.C. 553, and in the regulatory processes established in the Commodity Exchange
The new “Comments Online” system will collect and store comments and input received by the Commission. Specifically, the system includes a web form on
During an informal rulemaking or other statutory or regulatory notice and comment process, Commission personnel may manually remove a comment from publication if the commenter withdraws his or her comments before the comment period has closed or because the comment contains obscenities or other material deemed inappropriate for publication by the Commission.
Under the Privacy Act of 1974, 5 U.S.C. 552a, a “system of records” is defined as any group of records under the control of a federal government agency from which information about individuals is retrieved by name or other personal identifier. The Privacy Act establishes the means by which government agencies must collect, maintain, and use personally identifiable information associated with an individual in a government system of records.
Each government agency is required to publish a notice in the
Comments Online.
Unclassified.
This system is located in the Commission's principal office at Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581.
Individuals providing comments or other input to the Commission in response to proposed rules, industry filings or other Commission request for comments associated with Commission rules, policies or procedures, whether the individuals provide comments or input directly or through their representatives. Any individuals who may be discussed or identified in the comments or input provided by others to the Commission.
Incoming comments or other input to the Commission in response to proposed rules, industry filings or other Commission request for comments associated with Commission rules, policies or procedures, provided to the Commission via the web form on the
This system excludes comments or input for which the Commission has received and either has approved or not yet decided a Freedom of Information Act “request for confidential treatment.” Records related to such requests are covered under System of Record Notice CFTC-41, “Requests for Confidential Treatment.”
44 U.S.C. 3101, Administrative Procedure Act, 5 U.S.C. 553
To collect and maintain in an electronic system feedback from the public and industry groups regarding proposed rules and other Commission regulatory actions in accordance with the Administrative Procedure Act (“APA”) or other statutory or regulatory provisions, as well as input on Commission activities that may not be associated with notice and comment requirements.
Comments or input in this system, along with the commenter's name and organization, are published on the
The Comments Online system also contains the commenter's email address and other personal contact information the commenter may voluntarily provide to the Commission, such as phone number. The email address will be used for the Commission to send the commenter a verification of receipt of
Also, information in this system may be disclosed in accordance with the blanket routine uses numbered 1 through 19 that appear in the Commission's Privacy Act Systems of Records Notice, 76 FR 5974 (Feb. 2, 2011).
None.
Paper records are stored in file folders, binders, computer disks, and are uploaded into the Comments Online system. Electronic records, including comments or input and personal information provided through the web form on the
By name of the individual providing the comment or input, name of the individual on whose behalf a comment or input is provided, number assigned to the comment or input, or the subject matter, such as the proposed rule or industry filing to which the comment or input pertains. Also, by the name of any individual who is identified or discussed in the text of a comment or other input provided by another party.
Records in the Comments Online system, including personal information contained in the database and not published on
The retention and disposal period depends on the nature of the comment or input provided to the Commission. For example, comments that pertain to a Commission proposed rule or industry filing become part of the agency's central files and are kept permanently. Other input to the Commission may be kept for between one and 10 years, depending on the subject matter.
The Commission's Office of the Secretariat, located at the Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581.
Individuals seeking to determine whether this system of records contains information about themselves or seeking access to records about themselves in this system of records, or contesting the content of records about themselves contained in this system of records should address written inquiry to the Office of General Counsel, Paralegal Specialist, Commodity Futures Trading Commission, Three Lafayette Centre, 1155 21st Street, NW., Washington, DC 20581. Telephone (202) 418-5011.
Individuals and organizations providing comments or other input to the Commission.
None.
Department of Education.
Comment request.
The Department of Education (the Department), in accordance with the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3506(c)(2)(A)), provides the general public and Federal agencies with an opportunity to comment on proposed and continuing collections of information. This helps the Department assess the impact of its information collection requirements and minimize the reporting burden on the public and helps the public understand the Department's information collection requirements and provide the requested data in the desired format. The Director, Information Collection Clearance Division, Information Management and Privacy Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.
Interested persons are invited to submit comments on or before June 6, 2011.
Comments regarding burden and/or the collection activity requirements should be electronically mailed to
Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that Federal agencies provide interested parties an early opportunity to comment on information collection requests. The Director, Information Collection Clearance Division, Information Management and Privacy Services, Office of Management, publishes this notice containing proposed information collection requests at the beginning of the Departmental review of the information collection. The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.
Copies of the proposed information collection request may be accessed from
Individuals who use a telecommuni-cations device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Federal Energy Regulatory Commission, DOE.
Notice.
In compliance with the requirements of section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 3507, the Federal Energy Regulatory Commission (Commission or FERC) has submitted the information collection described below to the Office of Management and Budget (OMB) for review of the information collection requirements. Any interested person may file comments directly with OMB and should address a copy of those comments to the Commission as explained below. The Commission issued a Notice in the
Comments on the collection of information are due by May 9, 2011.
Address comments on the collection of information to the Office of Management and Budget, Office of Information and Regulatory Affairs, Attention: Federal Energy Regulatory Commission Desk Officer. Comments to OMB should be filed electronically, c/o
A copy of the comments should also be sent to: Federal Energy Regulatory Commission, Secretary of the Commission, 888 First Street, NE., Washington, DC 20426. Comments may be filed either on paper or on CD/DVD, and should refer to Docket No. IC11-725B-001. Documents must be prepared in an acceptable filing format and in compliance with Commission submission guidelines at
All comments may be viewed, printed or downloaded remotely via the Internet through FERC's homepage using the “eLibrary” link. For user assistance, contact
Ellen Brown may be reached by e-mail at
The information collected by the FERC-725B, Reliability Standards for Critical Infrastructure Protection (OMB Control No. 1902-0248), is required to implement the statutory provisions of section 215 of the Federal Power Act (FPA) (16 U.S.C. 824o). On January 18, 2008, the Commission issued order 706, approving eight Critical Infrastructure Protection (CIP) Reliability Standards submitted by the North American Electric Reliability Corporation (NERC) for Commission approval.
The CIP Reliability Standards require certain users, owners, and operators of the Bulk-Power System to comply with specific requirements to safeguard critical cyber assets.
The CIP Reliability Standards do not require a responsible entity to report to the Commission, ERO or Regional Entities, the various policies, plans, programs and procedures. However, a showing of the documented policies, plans, programs and procedures is required to demonstrate compliance with the CIP Reliability Standards.
The total
• Entities that have identified Critical Assets = 110,400 hours@$96 = $10,598,400.
• Entities that have not identified Critical Assets = 9,248 hours@$96 = $887,808.
• Storage Costs for Entities that have identified Critical Assets
The reporting burden includes the total time, effort, or financial resources expended to generate, maintain, retain, disclose, or provide the information including: (1) Reviewing instructions; (2) developing, acquiring, installing, and utilizing technology and systems for the purposes of collecting, validating, verifying, processing, maintaining, disclosing and providing information; (3) adjusting the existing ways to comply with any previously applicable instructions and requirements; (4) training personnel to respond to a collection of information; (5) searching data sources; (6) completing and reviewing the collection of information; and (7) transmitting, or otherwise disclosing the information.
Comments are invited on: (1) Whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information will have practical utility; (2) the accuracy of the agency's estimates of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility and clarity of the information to be collected; and (4) ways to minimize the burden of the collections of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j. Deadline for filing motions to intervene and protests, comments, recommendations, preliminary terms and conditions, and preliminary prescriptions: 60 days from the issuance date of this notice; reply comments are due 105 days from the issuance date of this notice.
Motions to intervene, protests, comments, recommendations, preliminary terms and conditions, and preliminary fishway prescriptions may be filed electronically via the Internet.
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application has been accepted for filing and is now is ready for environmental analysis.
l. The Project is connected with The Middle Fork American River Hydroelectric Project, FERC Project No. 2079, owned and operated by the Placer County Water Agency (PCWA). The project consists of a 3-phase, 60-kilovolt (kV), wood-pole transmission line extending 13.27 miles from PCWA's French Meadows powerhouse switchyard to PCWA's Middle Fork powerhouse (feature of Project 2079). The project includes a 3-phase, 60-kV transmission line extending approximately 900 feet from PCWA's Oxbow powerhouse (feature of project No. 2079) to the interconnection at PG&E's Weimar #1 60-kV transmission line. The transmission line right-of-way is 40 feet in width for its entire length. The project also includes a 230-kV tap at PCWA's Ralston powerhouse. The tap is wholly contained within the switchyard at Ralston powerhouse.
The French Meadows 60-kV transmission line is entirely within the boundaries of the Eldorado National Forest, and the Oxbow 60-kV tap is entirely within the boundaries of the Tahoe National Forest. The combined length of the two 60-kV transmission lines on National Forest System lands is 6.58 miles: 6.42 miles in the Eldorado National Forest and 0.16 mile in the Tahoe National Forest. Approximately 6.69 miles of the French Meadows 60-kV transmission line are located on private lands within the boundary of the Eldorado National Forest. The Oxbow tap is located entirely on National Forest System lands.
PG&E is not proposing to modify the existing project and does not plan any changes to the operation or maintenance of the transmission line.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Register online at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must (1) bear in all capital letters the title “PROTEST”, “MOTION TO INTERVENE”, “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” or “PRELIMINARY TERMS AND CONDITIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
o.
The application will be processed according to the following revised Hydro Licensing Schedule. Revisions to the schedule may be made as appropriate.
p. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection.
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
Motions to intervene, protests, comments, recommendations, preliminary terms and conditions, and preliminary fishway prescriptions may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site
The Commission's Rules of Practice require all intervenors filing documents with the Commission to serve a copy of that document on each person on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k. This application has been accepted for filing and is now ready for environmental analysis.
l.
m. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site at
Register online at
n. Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests of other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
All filings must (1) Bear in all capital letters the title “PROTEST,” “MOTION TO INTERVENE,” “COMMENTS,” “REPLY COMMENTS,” “RECOMMENDATIONS,” “PRELIMINARY TERMS AND CONDITIONS,” or “PRELIMINARY FISHWAY PRESCRIPTIONS;” (2) set forth in the heading the name of the applicant and the project number of the application to which the filing responds; (3) furnish the name, address, and telephone number of the person protesting or intervening; and (4) otherwise comply with the requirements of 18 CFR 385.2001 through 385.2005. All comments, recommendations, terms and conditions or prescriptions must set forth their evidentiary basis and otherwise comply with the requirements of 18 CFR 4.34(b). Agencies may obtain copies of the application directly from the applicant. A copy of any protest or motion to intervene must be served upon each representative of the applicant specified in the particular application. A copy of all other filings in reference to this application must be accompanied by proof of service on all persons listed in the service list prepared by the Commission in this proceeding, in accordance with 18 CFR 4.34(b) and 385.2010.
o. Procedural Schedule:
The application will be processed according to the following revised Hydro Licensing Schedule. Revisions to the schedule may be made as appropriate.
p. Final amendments to the application must be filed with the Commission no later than 30 days from the issuance date of this notice.
q. A license applicant must file no later than 60 days following the date of issuance of the notice of acceptance and ready for environmental analysis provided for in 5.22: (1) A copy of the water quality certification; (2) a copy of the request for certification, including proof of the date on which the certifying agency received the request; or (3) evidence of waiver of water quality certification.
r. Any qualified applicant desiring to file a competing application must submit to the Commission, on or before the specified intervention deadline date, a competing development application, or a notice of intent to file such an application. Submission of a timely notice of intent allows an interested person to file the competing development application no later than 120 days after the specified intervention deadline date. Applications for preliminary permits will not be accepted in response to this notice.
A notice of intent must specify the exact name, business address, and telephone number of the prospective applicant, and must include an unequivocal statement of intent to submit a development application. A notice of intent must be served on the applicant(s) named in this public notice.
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h.
i.
j.
All documents may be filed electronically via the Internet.
k.
l.
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
n.
o.
Take notice that on March 18, 2011, Tennessee Gas Pipeline Company (Tennessee), 1001 Louisiana Street, Houston, Texas 77002, filed an application in Docket No. CP11-142-000 pursuant to section 7(b) of the Natural Gas Act (NGA) and Part 157 of the Commission's regulations, requesting authorization to abandon in place and by removal certain inactive supply pipelines, associated meters, and appurtenances located primarily in the East and West Cameron areas in federal offshore waters of the Outer Continental Shelf, Louisiana, referred to as the Southwest Leg Abandonment Project. The facilities to be abandoned include approximately 64.5 miles of 30-inch, 10.5 miles of 24-inch, 13.5 miles of 16-inch and 2.5 miles of 10-inch supply pipelines, as well as related meters and associated appurtenances. Tennessee states that the subject facilities have been out of service due to damage received by Hurricane Ike in September 2008, all as more fully set forth in the application which is on file with the Commission and open to public inspection. The filing is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's Web site web at
Any questions concerning this application may be directed to Thomas G. Joyce, Manager, Certificates, Tennessee Gas Pipeline Company, 1001 Louisiana Street, Houston, Texas 77002, by telephone at (713) 420-3299, by facsimile at (713) 420-1473, or by e-mail at
There are two ways to become involved in the Commission's review of this project. First, any person wishing to obtain legal status by becoming a party to the proceedings for this project should, on or before the comment date stated below file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, a motion to intervene in accordance with the requirements of the Commission's Rules of Practice and Procedure (18 CFR 385.214 or 385.211) and the Regulations under the NGA (18 CFR 157.10). A person obtaining party status will be placed on the service list maintained by the Secretary of the Commission and will receive copies of all documents filed by the applicant and by all other parties. A party must submit 14 copies of filings made in the proceeding with the Commission and must mail a copy to the applicant and to every other party. Only parties to the proceeding can ask for court review of Commission orders in the proceeding.
However, a person does not have to intervene in order to have comments considered. The second way to participate is by filing with the Secretary of the Commission, as soon as possible, an original and two copies of comments in support of or in opposition to this project. The Commission will consider these comments in determining the appropriate action to be taken, but the filing of a comment alone will not serve to make the filer a party to the proceeding. The Commission's rules require that persons filing comments in opposition to the project provide copies of their protests only to the party or parties directly involved in the protest.
Protests and interventions may be filed electronically via the Internet in lieu of paper; see, 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site under the “e-Filing” link. The Commission strongly encourages electronic filings.
Comment Date: April 21, 2010.
On March 2, 2009 Green Island Power Authority, licensee for the Green Island Hydroelectric Project, filed an Application for a New License pursuant to the Federal Power Act (FPA) and the Commission's regulations thereunder. The Green Island Hydroelectric Project is on the Hudson River in Albany County, New York.
The license for Project No. 13 was issued for a period ending March 2, 2011. Section 15(a)(1) of the FPA, 16 U.S.C. 808(a)(1), requires the Commission, at the expiration of a license term, to issue from year-to-year an annual license to the then licensee under the terms and conditions of the prior license until a new license is issued, or the project is otherwise disposed of as provided in section 15 or any other applicable section of the FPA. If the project's prior license waived the applicability of section 15 of the FPA, then, based on section 9(b) of the Administrative Procedure Act, 5 U.S.C. 558(c), and as set forth at 18 CFR 16.21(a), if the licensee of such project has filed an application for a subsequent license, the licensee may continue to operate the project in accordance with the terms and conditions of the license after the minor or minor part license expires, until the Commission acts on its application. If the licensee of such a project has not filed an application for a subsequent license, then it may be required, pursuant to 18 CFR 16.21(b), to continue project operations until the Commission issues someone else a
If the project is subject to section 15 of the FPA, notice is hereby given that an annual license for Project No. 13 is issued to the Green Island Power Authority for a period effective March 3, 2011 through March 2, 2012, or until the issuance of a new license for the project or other disposition under the FPA, whichever comes first. If issuance of a new license (or other disposition) does not take place on or before March 2, 2012, notice is hereby given that, pursuant to 18 CFR 16.18(c), an annual license under section 15(a)(1) of the FPA is renewed automatically without further order or notice by the Commission, unless the Commission orders otherwise.
If the project is not subject to section 15 of the FPA, notice is hereby given that Green Island Power Authority is authorized to continue operation of the Green Island Hydroelectric Project, until such time as the Commission acts on its application for a subsequent license.
Take notice that on March 29, 2011, the applicants listed above submitted a revised baseline filing of their Statement of Operating Conditions for services provided under section 311 of the Natural Gas Policy Act of 1978 (“NGPA”).
Any person desiring to participate in this rate proceeding must file a motion to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Protests 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. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the date as indicated below. Anyone filing an intervention or protest must serve a copy of that document on the Applicant. Anyone filing an intervention or protest on or before the intervention or protest date need not serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric securities filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests 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. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
As it relates to any qualifying facility filings, the notices of self-certification [or self-recertification] listed above, do not institute a proceeding regarding qualifying facility status. A notice of self-certification [or self-recertification] simply provides notification that the entity making the filing has determined the facility named in the notice meets the applicable criteria to be a qualifying facility. Intervention and/or protest do not lie in dockets that are qualifying facility self-certifications or self-recertifications. Any person seeking to challenge such qualifying facility status may do so by filing a motion pursuant to 18 CFR 292.207(d)(iii). Intervention and protests may be filed in response to notices of qualifying facility dockets other than self-certifications and self-recertifications.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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 dockets(s). For assistance with any FERC Online service, please e-mail
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
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 5 p.m. Eastern time on the specified comment date. 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
This filing is accessible on-line at
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following open access transmission tariff filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests 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. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
As it relates to any qualifying facility filings, the notices of self-certification [or self-recertification] listed above, do not institute a proceeding regarding qualifying facility status. A notice of self-certification [or self-recertification] simply provides notification that the entity making the filing has determined the facility named in the notice meets the applicable criteria to be a qualifying facility. Intervention and/or protest do not lie in dockets that are qualifying facility self-certifications or self-recertifications. Any person seeking to challenge such qualifying facility status may do so by filing a motion pursuant to 18 CFR 292.207(d)(iii). Intervention and protests may be filed in response to notices of qualifying facility dockets other than self-certifications and self-recertifications.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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 dockets(s). For assistance with any FERC Online service, please e-mail
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests 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. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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 dockets(s). For assistance with any FERC Online service, please e-mail
Take notice that the Commission has received the following Natural Gas Pipeline Rate and Refund Report filings:
Any person desiring to intervene or to protest in any of the above proceedings
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St. NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
Take notice that the Commission received the following electric rate filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests 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. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
As it relates to any qualifying facility filings, the notices of self-certification [or self-recertification] listed above, do not institute a proceeding regarding qualifying facility status. A notice of self-certification [or self-recertification] simply provides notification that the entity making the filing has determined the facility named in the notice meets the applicable criteria to be a qualifying facility. Intervention and/or protest do not lie in dockets that are qualifying facility self-certifications or self-recertifications. Any person seeking to challenge such qualifying facility status may do so by filing a motion pursuant to 18 CFR 292.207(d)(iii). Intervention and protests may be filed in response to notices of qualifying facility dockets other than self-certifications and self-recertifications.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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 dockets(s). For assistance with any FERC Online service, please e-mail
Take notice that the Commission received the following electric corporate filings:
Take notice that the Commission received the following exempt wholesale generator filings:
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following electric reliability filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests 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. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
As it relates to any qualifying facility filings, the notices of self-certification [or self-recertification] listed above, do not institute a proceeding regarding qualifying facility status. A notice of self-certification [or self-recertification] simply provides notification that the entity making the filing has determined the facility named in the notice meets the applicable criteria to be a qualifying facility. Intervention and/or protest do not lie in dockets that are qualifying facility self-certifications or self-recertifications. Any person seeking to challenge such qualifying facility status may do so by filing a motion pursuant to 18 CFR 292.207(d)(iii). Intervention and protests may be filed in response to notices of qualifying facility dockets other than self-certifications and self-recertifications.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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 dockets(s). For assistance with any FERC Online service, please e-mail
Take notice that the Commission received the following electric rate filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests 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. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
As it relates to any qualifying facility filings, the notices of self-certification [or self-recertification] listed above, do not institute a proceeding regarding qualifying facility status. A notice of self-certification [or self-recertification] simply provides notification that the entity making the filing has determined the facility named in the notice meets the applicable criteria to be a qualifying facility. Intervention and/or protest do not lie in dockets that are qualifying facility self-certifications or self-recertifications. Any person seeking to challenge such qualifying facility status may do so by filing a motion pursuant to 18 CFR 292.207(d)(iii). Intervention and protests may be filed in response to notices of qualifying facility dockets other than self-certifications and self-recertifications.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
Take notice that the Commission received the following electric rate filings:
Take notice that the Commission received the following open access transmission tariff filings:
Any person desiring to intervene or to protest in any of the above proceedings must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214) on or before 5 p.m. Eastern time on the specified comment date. It is not necessary to separately intervene again in a subdocket related to a compliance filing if you have previously intervened in the same docket. Protests 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. Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant. In reference to filings initiating a new proceeding, interventions or protests submitted on or before the comment deadline need not be served on persons other than the Applicant.
As it relates to any qualifying facility filings, the notices of self-certification [or self-recertification] listed above, do not institute a proceeding regarding qualifying facility status. A notice of self-certification [or self-recertification] simply provides notification that the entity making the filing has determined the facility named in the notice meets the applicable criteria to be a qualifying facility. Intervention and/or protest do not lie in dockets that are qualifying facility self-certifications or self-recertifications. Any person seeking to challenge such qualifying facility status may do so by filing a motion pursuant to 18 CFR 292.207(d)(iii). Intervention and protests may be filed in response to notices of qualifying facility dockets other than self-certifications and self-recertifications.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First St., NE., Washington, DC 20426.
The filings in the above proceedings are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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 dockets(s). For assistance with any FERC Online service, please e-mail
The staff of the Federal Energy Regulatory Commission (FERC or Commission) has prepared an environmental assessment (EA) for the Appalachian Gateway Project proposed by Dominion Transmission, Inc. (Dominion) in the above-referenced docket. Dominion requests authorization to construct and operate the Appalachian Gateway Project including 110 miles of 20- through 30-inch-diameter pipeline (26.3 miles in West Virginia and 74.9 miles in Pennsylvania) along with associated minor pipeline and support facilities, and additional compression, which would increase Dominion's authorized capacity for the transportation of natural gas by about 484 million cubic feet per day.
The EA assesses the potential environmental effects of the construction and operation of the Appalachian Gateway Project in accordance with the requirements of the National Environmental Policy Act of 1969 (NEPA). The FERC staff concludes that approval of the proposed project, with appropriate mitigating measures, would not constitute a major Federal action significantly affecting the quality of the human environment.
The proposed Appalachian Gateway Project includes the following facilities:
• the 5.3 miles, 20-inch-diameter TL-570, EXT. 1 pipeline in Kanawha County, West Virginia;
• the 6 mile, 24-inch-diameter TL-492, EXT. 5 pipeline in Greene County, Pennsylvania;
• the 42.3 mile 30-inch-diameter TL-590 pipeline in Marshall and Greene Counties, Pennsylvania;
• the 54.2 mile, 24-inch-diameter TL-591 pipeline in Greene, Washington, Allegheny, and Westmoreland Counties, Pennsylvania;
• the 0.5 mile, 16 inch-diameter TL-596 pipeline in Wetzel County, West Virginia;
• the 0.1 mile, 10-inch-diameter TL-597 pipeline in Wetzel County, West Virginia;
• the 0.3 mile, 16-inch-diameter TL-598 pipeline in Harrison County, West Virginia;
• the 0.4 mile, 16-inch-diamter TL-599 pipeline in Harrison County, West Virginia;
• the new 4,735 horsepower (hp) Chelyan Compressor Station in County, West Virginia;
• the new 3,550 hp Lewis Wetzel Compressor Station in Wetzel County, West Virginia;
• the new 1,775 hp Morrison Compressor Station in Harrison County, West Virginia;
• the new 6,130 hp Burch Ridge Compressor Station in Mashall County, West Virginia;
• modify the existing Pepper Compressor Station with the addition of 1,665 hp of new compression;
• modify the existing reciprocating engine at the Schutte Compressor Station in Doddridge County, West Virginia by replacing the cylinder liners;
• the TL-591 Metering and Regulation (M&R) Station, in Westmoreland County, Pennsylvania;
• the Crayne M&R Station in Green County, Pennsylvania; and
• pig launchers, receivers and mainline valves along the pipelines.
The EA has been placed in the public files of the FERC and is available for public viewing on the FERC's Web site at
Copies of the EA have been mailed to Federal, State, and local government representatives and agencies; elected officials; Native American Tribes; potentially affected landowners and other interested individuals and groups; and newspapers in the project area; and parties to this proceeding.
Any person wishing to comment on the EA may do so. Your comments should focus on the potential environmental effects, reasonable alternatives, and measures to avoid or lessen environmental impacts. The more specific your comments, the more useful they will be. To ensure that your comments are properly recorded and considered prior to a Commission decision on the proposal, it is important that the FERC receives your comments in Washington, DC on or before May 6, 2011.
For your convenience, there are three methods you can use to submit your comments to the Commission. In all instances, please reference the project docket number (CP10-448-000) with your submission. The Commission encourages electronic filing of comments and has dedicated eFiling expert staff available to assist you at (202) 502-8258 or
(1) You may file your comments electronically by using the eComment feature, which is located on the Commission's Web site at
(2) You may file your comments electronically by using the eFiling feature, which is located on the Commission's Web site at
(3) You may file a paper copy of your comments at the following address:Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888 First Street, NE., Room 1A, Washington, DC 20426.
Although your comments will be considered by the Commission, simply filing comments will not serve to make the commenter a party to the proceeding. Any person seeking to become a party to the proceeding must file a motion to intervene pursuant to Rule 214 of the Commission's Rules of Practice and Procedures (18 CFR 385.214).
Affected landowners and parties with environmental concerns may be granted intervenor status upon showing good cause by stating that they have a clear and direct interest in this proceeding which would not be adequately represented by any other parties. You do not need intervenor status to have your comments considered.
Additional information about the project is available from the Commission's Office of External Affairs, at (866) 208-FERC or on the FERC Web site (
In addition, the Commission offers a free service called eSubscription which allows you to keep track of all formal issuances and submittals in specific dockets. This can reduce the amount of time you spend researching proceedings by automatically providing you with notification of these filings, document summaries, and direct links to the documents. Go to
Take notice that on April 1, 2011, Hal D. Truax submitted for filing, an application for authority to hold interlocking positions, pursuant to section 305(b) of the Federal Power Act, 16 U.S.C. 825d (b) (2008), part 45 of Title 18 of the Code of Federal Regulations, 18 CFR part 45, and Commission Order No. 664, 112 FERC ¶ 61,298 (2005).
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests 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. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
This is a supplemental notice in the above-referenced proceeding of XO Energy MW, LP's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 19, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
This is a supplemental notice in the above-referenced proceeding of XO Energy NY, LP's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 19, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
This is a supplemental notice in the above-referenced proceeding Stream Energy Maryland, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 19, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
This is a supplemental notice in the above-referenced proceeding of Monterey CA, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 19, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
This is a supplemental notice in the above-referenced proceeding Southern California Telephone Company's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 19, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
This is a supplemental notice in the above-referenced proceeding of Monterey MW, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 19, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
This is a supplemental notice in the above-referenced proceeding of Monterey NY, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 19, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
This is a supplemental notice in the above-referenced proceeding of Monterey MA, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
This is a supplemental notice in the above-referenced proceeding SBR Energy, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 19, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
This is a supplemental notice in the above-referenced proceeding of XO Energy MA, LP's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is April 19, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also 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
On March 11, 2011, Oregon Winds Hydro, LLC filed an application for a preliminary permit, pursuant to section 4(f) of the Federal Power Act (FPA), proposing to study the feasibility of the Oregon Winds Pumped Storage Project to be located on the John Day River, near Condon, Gilliam County, Oregon. The sole purpose of a preliminary permit, if issued, is to grant the permit holder priority to file a license application during the permit term. A preliminary permit does not authorize the permit holder to perform any land-disturbing activities or otherwise enter upon lands or waters owned by others without the owners' express permission.
The proposed project will consist of the following: (1) An upper reservoir with a total storage capacity of 12,000 acre-feet at a normal maximum operating elevation of 2,480 feet mean sea level (msl); (2) a 60-foot-high, 9,120-foot-long upper embankment, Ring Dam; (3) a 200-foot-long, 19.2-foot-diameter concrete-lined low-pressure tunnel; (4) a lower reservoir with a total/usable storage capacity of 12,330 acre-feet at 1,240 feet msl; (5) a 6,500-foot-long, 19.2-foot-diameter concrete and steel-lined high-pressure tunnel; (6) an underground power house located 800 feet southwest of the lower reservoir; (7) a 13-mile-long, 230-kilovolt (kV) transmission line extending from the project substation to the point of interconnection with an existing overhead 500-kV transmission line. The estimated annual generation of the Oregon Winds Pumped Storage Project would be 1,533 gigawatt-hours.
More information about this project, including a copy of the application, can be viewed or printed on the “eLibrary” link of Commission's Web site at
Take notice that on March 18, 2011, The City Utility Commission of the City of Owensboro, Kentucky, filed a petition for waiver or exemption of any reciprocity-based standards of conduct or open access same-time information system (OASIS) requirements under Order No. 888, FERC Stats. & Regs. ¶ 31,036 (1996), Order No. 890, FERC Stats. & Regs. ¶ 31,241 (2007), or Order No. 717, 125 FERC ¶ 61,064 (2008).
Any person desiring to intervene or to protest this filing must file in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211, 385.214). Protests 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. Any person wishing to become a party must file a notice of intervention or motion to intervene, as appropriate. Such notices, motions, or protests must be filed on or before the comment date. On or before the comment date, it is not necessary to serve motions to intervene or protests on persons other than the Applicant.
The Commission encourages electronic submission of protests and interventions in lieu of paper using the “eFiling” link at
This filing is accessible on-line at
The Federal Energy Regulatory Commission hereby gives notice that members of its staff may attend the meeting of the Southwest Power Pool, Inc. (SPP) Markets Operations Policy Committee (MOPC), as noted below. Their attendance is part of the Commission's ongoing outreach efforts.
April 12, 2011 (8 a.m.-5 p.m.), April 13, 2011 (8 a.m.-3 p.m.), Doubletree Hotel, 616 West 7th Street, Tulsa, OK 74127, 800-838-7914.
The discussions may address matters at issue in the following proceedings:
These meetings are open to the public.
For more information, contact Patrick Clarey, Office of Energy Market Regulation, Federal Energy Regulatory Commission at (317) 249-5937 or
Export-Import Bank of the U.S.
Submission for OMB review and comments request.
The Export-Import Bank of the United States (Ex-Im Bank), as a part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal Agencies to comment on the proposed information collection, as required by the Paperwork Reduction Act of 1995.
Our customers will be able to submit this form on paper or electronically. The information collected will allow Ex-Im Bank to determine the applicability of a proposed export transaction for receipt of an indication of a willingness to consider financing medium- and long-term guarantee, direct loan and insurance programs.
Form can be viewed at
Comments should be received on or before May 9, 2011 to be assured of consideration.
Comments may be submitted electronically on
Ex-Im Bank uses the requested information to determine the applicability of the proposed export transaction for receipt of this indication of willingness to consider financing.
Federal Communications Commission.
Notice.
This document announces the next meeting of the Video Programming Accessibility Advisory Committee (“Committee” or “VPAAC”). The meeting will address the provision of closed captioning of Internet programming previously captioned on television, video description of television programming, accessible emergency information for people with vision disabilities delivered over video programming, video programming devices that can render closed captioning and video description, and accessible user interfaces, menus, and programming guides on video programming devices.
The Committee's next meeting will take place on Thursday, May 5, 2011, 9 a.m. to 5 p.m. at the headquarters of the Federal Communications Commission (“Commission”).
Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554.
Pam Gregory, Consumer and Governmental Affairs Bureau, 202-418-2498 (voice), 202-418-1169 (TTY), or
On December 7, 2010, in document DA-2320, Chairman Julius Genachowski announced the establishment and appointment of members of the VPAAC, following a nominations period that closed on November 1, 2010. This Committee is established in accordance with the Twenty-First Century Communications and Video Accessibility Act of 2010, Public Law 111-260 (“CVAA”). The purpose of the VPAAC is to develop recommendations on closed captioning of Internet
Open captioning and sign language interpreters will be provided. Other reasonable accommodations for people with disabilities are available upon request. Please include a description of the accommodation you will need and tell us how to contact you if we need more information. Make your request as early as possible. Last minute requests will be accepted, but may be impossible to fill. Send an e-mail to
Federal Communications Commission.
Notice.
This document announces the date of the Emergency Access Advisory Committee's (“Committee or EAAC”) next meeting. The Committee will address the status of the national survey of persons with disability and seniors to learn about preferences for emergency calling when 9-1-1 call centers have the capacity to communicate with callers via voice, data, text and video under the Next Generation 9-1-1. The Committee will discuss options for reporting out the results of the national survey.
The Committee's next meeting will take place on Friday, April 8, 2011, 10:30 a.m. to 4:30 p.m. (EST), at the headquarters of the Federal Communications Commission (FCC).
Federal Communications Commission, 445 12th Street, SW., Washington, DC 20554.
Cheryl King, Consumer and Governmental Affairs Bureau, (202) 418-2284 (voice) or (202) 418-0416 (TTY), (
On December 7, 2010, in document DA 10-2318, Chairman Julius Genachowski announced the establishment and appointment of members and Co-Chairpersons of the EAAC, an advisory committee required by the Twenty-first Century Communications and Video Accessibility Act of 2010, Public Law 111-260 (CVAA), which directs that an advisory committee be established, for the purpose of achieving equal access to emergency services by individuals with disabilities as part of our nation's migration to a national Internet protocol-enabled emergency network, also known as the next generation 9-1-1 system (“NG9-1-1”).
The purpose of the EAAC is to determine the most effective and efficient technologies and methods by which to enable access to NG9-1-1 emergency services by individuals with disabilities. In order to fulfill this mission, the CVAA directs that within one year after the EAAC's members are appointed, the Committee shall conduct a national survey, with the input of groups represented by the Committee's membership, after which the Committee shall develop and submit to the Commission recommendations to implement such technologies and methods.
The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an e-mail to:
To request materials in accessible formats for people with disabilities (Braille, large print, electronic files, audio format), send an e-mail to
The Federal Communications Commission will hold an Open Meeting on the subjects listed below on Thursday, April 7, 2011, which is scheduled to commence at 10:30 a.m. in Room TW-C305, at 445 12th Street, SW., Washington, DC.
The meeting site is fully accessible to people using wheelchairs or other mobility aids. Sign language interpreters, open captioning, and assistive listening devices will be provided on site. Other reasonable accommodations for people with disabilities are available upon request. In your request, include a description of the accommodation you will need and a way we can contact you if we need more information. Last minute requests will be accepted, but may be impossible to fill. Send an e-mail to:
Additional information concerning this meeting may be obtained from Audrey Spivack or David Fiske, Office of Media Relations, (202) 418-0500; TTY 1-888-835-5322. Audio/Video coverage of the meeting will be broadcast live with open captioning over the Internet from the FCC Live Web page at
For a fee this meeting can be viewed live over George Mason University's Capitol Connection. The Capitol Connection also will carry the meeting live via the Internet. To purchase these services call (703) 993-3100 or go to
Copies of materials adopted at this meeting can be purchased from the FCC's duplicating contractor, Best Copy and Printing, Inc. (202) 488-5300; Fax (202) 488-5563; TTY (202) 488-5562. These copies are available in paper format and alternative media, including large print/type; digital disk; and audio and video tape. Best Copy and Printing, Inc. may be reached by e-mail at
Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given that the Federal Deposit Insurance Corporation's Board of Directors will meet in open session at 10 a.m. on Tuesday, April 12, 2011, to consider the following matters:
The meeting will be held in the Board Room on the sixth floor of the FDIC Building located at 550 17th Street, NW., Washington, DC.
This Board meeting will be Webcast live via the Internet and subsequently made available on-demand approximately one week after the event. Visit
The FDIC will provide attendees with auxiliary aids (
Requests for further information concerning the meeting may be directed to Mr. Robert E. Feldman, Executive Secretary of the Corporation, at 202-898-7043.
The notificants listed below have applied under the Change in Bank Control Act (12 U.S.C. 1817(j)) and § 225.41 of the Board's Regulation Y (12 CFR 225.41) to acquire shares of a bank or bank holding company. The factors that are considered in acting on the notices are set forth in paragraph 7 of the Act (12 U.S.C. 1817(j)(7)).
The notices are available for immediate inspection at the Federal Reserve Bank indicated. The notices also will be available for inspection at the offices of the Board of Governors. Interested persons may express their views in writing to the Reserve Bank indicated for that notice or to the offices of the Board of Governors. Comments must be received not later than April 22, 2011.
A. Federal Reserve Bank of Kansas City (Dennis Denney, Assistant Vice President), 1 Memorial Drive, Kansas City, Missouri 64198-0001:
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Division of Consumer and Business Education, Federal Trade Commission (“FTC” or “Commission”).
30-day notice of submission of information collection approval from the Office of Management and Budget (“OMB”) and request for comments.
As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, the FTC is submitting a Generic Information Collection Request (Generic ICR): “Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery” to OMB for approval under the Paperwork Reduction Act (44 U.S.C. 3501
Comments must be submitted by May 9, 2011.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
To request additional information, please contact Nicole Vincent at 202-326-2372.
Feedback collected under this generic clearance will provide useful information, but it will not yield data that can be generalized to the overall population. This type of generic clearance for qualitative information will not be used for quantitative information collections that are designed to yield reliably actionable results, such as monitoring trends over time or documenting program performance. Such data uses require more rigorous designs that address: the target population to which generalizations will be made, the sampling frame, the sample design (including stratification and clustering), the precision requirements or power calculations that justify the proposed sample size, the expected response rate, methods for assessing potential non-response bias, the protocols for data collection, and any testing procedures that were or will be undertaken prior fielding the study. Depending on the degree of influence the results are likely
The FTC received no comments in response to the 60-day notice published in the
Below are the FTC's projected average annual estimates for the next three years:
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number.
You can file a comment online or on paper. For the FTC to consider your comment, we must receive it on or before May 9, 2011. Write “FTC Generic Clearance ICR, Project No. P035201” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment doesn't include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment doesn't include any sensitive health information, like medical records or other individually identifiable health information. In addition, don't include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential * * *, ” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online, or to send them to the Commission by courier or overnight service. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “FTC Generic Clearance ICR, Project No. P035201” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex J), 600 Pennsylvania Avenue, NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.
Comments on any proposed information collection requirements subject to review under the PRA should additionally be submitted to OMB. If sent by U.S. mail, they should be addressed to Office of Information and Regulatory Affairs, Office of Management and Budget, Attention: Desk Officer for the Federal Trade Commission, New Executive Office Building, Docket Library, Room 10102, 725 17th Street, NW.,Washington, DC 20503. Comments sent to OMB by U.S. postal mail, however, are subject to delays due to heightened security precautions. Thus, comments instead should be sent by facsimile to (202) 395-5167.
Visit the Commission Website at
Assistant Secretary for Planning and Evaluation, HHS.
Notice of meeting.
This notice announces public meetings of the Technical Advisory Panel on Medicare Trustee Reports (Panel). Notice of these meetings is given under the Federal Advisory Committee Act (5 U.S.C. App. 2, section 10(a)(1) and (a)(2)). The Panel will discuss the short-term (10 year) projection methods and assumptions in projecting Medicare health spending and may make recommendations to the Medicare Trustees on how the Trustees might more accurately estimate health spending in the short run. The Panel's discussion is expected to be very technical in nature and will focus on the actuarial and economic assumptions and methods by which Trustees might more accurately measure health spending. Although panelists are not limited in the topics they may discuss, the Panel is not expected to discuss or recommend changes in current or future
The meetings will be held at HHS headquarters at 200 Independence Ave., SW., Washington, DC 20201, Room 425A.
Donald T. Oellerich (202) 690-8410,
42 U.S.C. 217a; Section 222 of the Public Health Services Act, as amended. The panel is governed by provisions of Public Law 92-463, as amended (5 U.S.C. Appendix 2), which sets forth standards for the formation and use of advisory committees.
Part A (Office of the Secretary), Statement of Organization, Functions, and Delegations of Authority of the Department of Health and Human Services (HHS) is being amended at Chapter AE, Office of the Assistant Secretary for Planning and Evaluation (ASPE) as last amended at 67 FR 61341-42 dated September 30, 2002 and most recently at 73 FR 19977, dated April 16, 2010. This reorganization is to realign the functions of ASPE to reflect the current structure and areas of focus. The changes are as follows:
I. Under Section AE.20 Functions, delete Paragraph D, Office of Disability, Aging and Long-Term Care Policy (AEW), in its entirety and replace with the following:
D. The Office of Disability, Aging and Long-Term Care Policy is responsible for the development, coordination, research and evaluation of HHS policies and programs that support the independence, productivity, health and well being of children, working age adults, and older persons with disabilities. The office is also responsible for policy coordination and research to promote the economic and social well-being of older Americans. The Office coordinates its work with aging and disability-related agencies and programs throughout the government, including the Departments of Justice, Labor, Education, Transportation, Housing and Urban Development, the Social Security Administration and the Office of National Drug Control Policy.
1. The Division of Disability and Aging Policy is responsible for policy development, coordination, research and evaluation of policies and programs focusing on persons with disabilities and older Americans (Older Americans Act). Activities related to the Older Americans Act are carried out in coordination with the Office of the Assistant Secretary for Aging. This includes measuring and evaluating the impact of programs authorized by the Older Americans Act. The Division is also responsible for supporting the development and coordination of crosscutting disability and aging data and policies within the Department and other federal agencies. Areas of focus include assessing the interaction between the health, disability, and economic well-being of persons of all ages with disabilities including the prevalence of disability and disabling conditions; describing the socio-demographic characteristics of relevant populations; determining service use, income, employment, and program participation patterns; and coordinating the development of disability and aging data and policies that affect the characteristics, circumstances and needs of older Americans and disabled populations. The Division's responsibilities include long-range planning, budget and economic analysis, program analysis, review of regulations and reports on legislation, review and conduct of research and evaluation activities, and information dissemination.
2. The Division of Long-Term Care Policy is responsible for coordination, development, research and evaluation of HHS policies and programs which address the long-term care and personal assistance needs of people of all ages with functional impairments and disabilities. The Division is the focal point for policy development and analysis related to the long-term care services components of the Affordable Care Act as well as Medicare, Medicaid, and including nursing facility services, community residential services, personal assistance services, home health and rehabilitation services, and the integration of acute, post-acute and long-term care services. The Division's responsibilities include long-range planning, budget and economic analysis, program analysis, review of regulations and reports on legislation, review and conduct of research and evaluation activities, and information dissemination.
3. The Division of Behavioral Health and Intellectual Disabilities Policy is responsible for analysis, coordination, research and evaluation of policies related to individuals with severe intellectual disabilities, severe addictions and/or severe and persistent mental illness. The Division's responsibilities include long-range planning, budget and economic analysis, data development and analysis, program analysis, review of regulations and reports on legislation, review and conduct of research and evaluation activities, and information
II. Delegations of Authority: All delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegation, provided they are consistent with this reorganization.
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 for opportunity for public comment on proposed data collection projects, the Centers for Disease Control and Prevention (CDC) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the data collection plans and instruments, call 404-639-5960 and send comments to Daniel Holcomb, CDC Acting Reports Clearance Officer, 1600 Clifton Road, MS-D74, Atlanta, GA 30333 or send an e-mail to
Comments are invited on: (a) Whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology. Written comments should be received within 60 days of this notice.
Epidemiologic Study of Health Effects Associated With Low Pressure Events in Drinking Water Distribution Systems —New—National Center for Emerging and Zoonotic Infectious Diseases—Office of Infectious Diseases—CDC.
In the United States, drinking water distribution systems are designed to deliver safe, pressurized drinking water to our homes, hospitals, schools and businesses. However, the water distribution infrastructure is 50-100 years old in much of the U.S. and an estimated 240,000 water main breaks occur each year. Failures in the distribution system such as water main breaks, cross-connections, back-flow, and pressure fluctuations can result in potential intrusion of microbes and other contaminants that can cause health effects, including acute gastrointestinal and respiratory illness.
Approximately 200 million cases of acute gastrointestinal illness occur in the U.S. each year, but we don't have reliable data to assess how many of these cases are associated with drinking water. Further, data are even more limited on the human health risks associated with exposure to drinking water during and after the occurrence of low pressure events (such as water main breaks) in drinking water distribution systems. A study conducted in Norway from 2003-2004 found that people exposed to low pressure events in the water distribution system had a higher risk for gastrointestinal illness. A similar study is needed in the United States.
The purpose of this data collection is to conduct an epidemiologic study in the U.S. to assess whether individuals exposed to low pressure events in the water distribution system are at an increased risk for acute gastrointestinal or respiratory illness. This study would be, to our knowledge, the first U.S. study to systematically examine the association between low pressure events and acute gastrointestinal and respiratory illnesses. Study findings will inform the Environmental Protection Agency (EPA), CDC, and other drinking water stakeholders of the potential health risks associated with low pressure events in drinking water distribution systems and whether additional measures (
We will conduct a cohort study among households that receive water from five water utilities across the U.S. The water systems will be geographically diverse and will include both chlorinated and chloraminated systems. These water utilities will provide information about low pressure events that occur during the study period. Households in areas exposed to the low pressure event and an equal number of households in an unexposed area will be randomly selected and sent a survey questionnaire. After consenting to participate, households will be asked about symptoms and duration of any recent gastrointestinal or respiratory illness, tap water consumption, and other factors including international travel, daycare attendance or employment, and exposure to under-cooked or unpasteurized food, pets and other animal contact, and recreational water. Study participants will be able to choose their method of survey response from a variety of options including a paper survey, telephone-administered survey, or Web-based survey. A Spanish language version of the survey for all response options will also be available. Participation in this study will be voluntary. No financial compensation will be provided to study participants. The study duration is anticipated to last 12 months. An estimated 5,200 individuals will be contacted and we anticipate 2,080 adults (18 years of age or older) will consent to participate in this study. We will conduct a pilot study (duration 3 months) prior to launching the full epidemiologic study. An estimated 1,000 individuals will be contacted and we anticipate 400 adults (18 years of age or older) will consent to participate in the pilot study. The total estimated annualized hours associated with this study, including the pilot, is expected to be 601.
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail to
Indicators of the Performance of Local, State, Territorial, and Tribal Education Agencies in HIV Prevention, Coordinated School Health Program, and Asthma Management Activities for Adolescent and School Health Programs (OMB No. 0920-0672, exp. 6/30/2011)—Revision—National Center for Chronic Disease Prevention and Health Promotion (NCCDPHP), Centers for Disease Control and Prevention (CDC).
CDC is requesting OMB approval for three years to continue annual information collection for the Indicators for School Health programs. The Indicators assess programmatic activities among local education agencies (LEA) and State, territorial, and Tribal government education agencies (SEAs, TEAs, and TGs) funded by the Division of Adolescent and School Health (DASH), Centers for Disease Control and Prevention. Currently, the Indicators for School Health Programs are the only standardized annual reporting process for HIV prevention activities or coordinated school health program (CSHP) activities among LEAs and SEAs/TEAs/TGs funded by DASH. The questionnaires correspond to the specific funding source from the Division of Adolescent and School Health: two questionnaires pertain to HIV-prevention program activities among LEAs and SEAs/TEAs/TGs; one pertains to CSHP/PANT activities among SEAs/TGs; and one pertains to asthma management activities among LEAs. All information is collected electronically on a Web site managed by DASH.
Two HIV prevention questionnaires include questions on project planning, materials distribution, professional development activities, provision of technical assistance, collaboration with external partners, and reducing health disparities among populations at disproportionate risk. The CSHP/PANT questionnaire focuses on the activities above as well as on physical activity, healthy eating, and tobacco-use prevention activities. The asthma management questionnaire includes questions on project planning, materials distribution, professional development activities, provision of technical assistance, collaboration with external partners, reducing health disparities among populations at disproportionate risk, and health services.
The information collected by CDC is used to: (1) Provide standardized information about how LEAs and SEAs/TEAs/TGs use funds for programs in HIV prevention, asthma management, and coordinated school health/physical activity, nutrition, and tobacco-use prevention (CSHP/PANT); (2) assess the extent to which programmatic adjustments are indicated; (3) provide descriptive and process information about program activities; and (4) provide greater accountability for use of public funds.
The questionnaires previously approved for collecting FY2009 data will be used to collect FY2010 data. Minor changes to the questionnaires will be implemented for the FY2011 and FY2012 data collections, however, the proposed changes will not alter the estimated burden per response. An increase in the average number of funded programs over the three years of this clearance will result in a net increase in burden hours. A minor change to the title of the clearance is being requested to more accurately reflect the participation of Territorial and Tribal Education Agencies.
There are no costs to respondents other than their time. The total estimated annualized burden hours are 811.
The Centers for Disease Control and Prevention (CDC) publishes a list of information collection requests under review by the Office of Management and Budget (OMB) in compliance with the Paperwork Reduction Act (44 U.S.C. chapter 35). To request a copy of these requests, call the CDC Reports Clearance Officer at (404) 639-5960 or send an e-mail to
Report of Verified Case of Tuberculosis (RVCT), (OMB No. 0920-0026) exp. 05/31/2011—Extension—National Center for HIV/AIDS, Viral Hepatitis, STD, and TB Prevention (NCHHSTP), Centers for Disease Control and Prevention (CDC).
In the United States, an estimated 10 to 15 million people are infected with
CDC conducts and maintains the national surveillance system pursuant to the provisions of Section 301(a) of the Public Service Act [42 U.S.C. 241] and Section 306 of the Public Service Act [42 U.S.C. 241(a)]. National TB surveillance has been maintained by the U.S. Public Health Service and CDC through the cooperation of the States since 1953. Data are collected by 60 reporting areas (the 50 States, the District of Columbia, New York City, Puerto Rico, and 7 jurisdictions in the Pacific and Caribbean).
CDC publishes an annual report using RVCT data to summarize national TB statistics and also periodically conducts special analyses for publication to further describe and interpret national TB data. These data assist in public health planning, evaluation, and resource allocation. Reporting areas also review and analyze their RVCT data to monitor local TB trends, evaluate program success, and focus resources to eliminate TB. No other Federal agency collects this type of national TB data.
The total estimated burden hours are approximately 6720 burden hours, an estimated decrease of 1330 hours. This decrease is due to having fewer TB cases in the United States as we continue progress towards TB elimination. There is no cost to respondents except for their time.
Centers for Medicare & Medicaid Services (CMS), HHS.
Notice.
This notice contains the final fiscal year (FY) 2011 wage indices and hospital reclassifications and other related tables which reflect changes required by or resulting from the implementation of section 102 of the Medicare and Medicaid Extenders Act of 2010. MMEA requires the extension of the expiration date for certain geographic reclassifications and special exception wage indices through September 30, 2011.
Brian Slater, (410) 786-5229.
The final rule setting forth the Medicare fiscal year (FY) 2011 hospital inpatient prospective payment systems (IPPS) for acute care hospitals and the long-term care hospital prospective payment system (LTCH PPS) (hereinafter referred to as the FY 2011 IPPS/LTCHPPS final rule) appeared in the August 16, 2010
On December 15, 2010, the Medicare and Medicaid Extenders Act (MMEA) of 2010 (Pub. L. 111-309) was enacted. Section 102 of the MMEA extends section 508 of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (MMA) (Pub. L. 108-173) reclassifications and certain additional special exceptions through September 30, 2011. This notice addresses the provisions of the MMEA that impact the FY 2011 IPPS final wage index tables.
Section 102 of the MMEA of 2010, extends through the end of FY 2011 wage index reclassifications under section 508 of the MMA and certain special exceptions (for example, those special exceptions contained in the final rule that appeared in the
Under section 508 of MMA, a qualifying hospital could appeal the wage index classification otherwise applicable to the hospital and apply for reclassification to another area of the State in which the hospital is located or, at the discretion of the Secretary, to an area within a contiguous State. We implemented this process through notices published in the
Section 102 of the MMEA has extended the hospital reclassifications originally received under section 508 and certain special exceptions through September 30, 2011 (FY 2011). Furthermore, effective April 1, 2011, section 102 of the MMEA also requires that in determining the wage index applicable to hospitals that qualify for wage index reclassification, the Secretary shall remove the section 508 and special exception hospitals' wage data from the calculation of the reclassified wage index if doing so increases the reclassified wage index. If the section 508 or special exception hospital's wage index applicable for the period beginning on October 1, 2010, and ending on March 30, 2011, is lower than for the period beginning on April 1, 2011, and ending on September 30, 2011, the Secretary shall pay the hospital an additional amount that reflects the difference between the wage indices for the two periods. As a result of these changes, we have recalculated certain wage index values to account for the new legislation.
Hospitals receiving an extension of their section 508 reclassifications or special exceptions wage indices are shown in Table 9B of the Addendum to this notice. Please note we are not making reclassification decisions on behalf of hospitals in this extension as we did with the MIPPA provision. (Because MIPPA was enacted prior to the finalization of the FY 2009 rates, we were able to modify reclassifications that had not yet taken effect. In contrast, MMEA was enacted in the middle of the fiscal year, and reclassifications are already in effect). Also, as explained in this notice, in cases where we have removed section 508/special exception hospital data from the reclassification wage index (effective April 1), we have
When originally implementing section 508 of the MMA, we required each hospital to submit a request in writing by February 15, 2004, to the Medicare Geographic Classification Review Board (MGCRB), with a copy to CMS. We will neither require nor accept written requests for the extension required by MMEA, since that law simply provides a 1 year continuation through the end of FY 2011 for any section 508 reclassifications and special exceptions wage indices that expired September 30, 2010.
The FY 2011 final wage index values and geographic adjustment factors (GAF) for hospitals affected by section 102 of the MMEA are included in Tables 2, 4C, and 9B of the Addendum to this notice, as well as in a Table showing the hospitals that have been removed from Table 9A. These tables also are posted on our Web site at
This document does not impose information collection and recordkeeping requirements. Consequently, it need not be reviewed by the Office of Management and Budget under the authority of the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35).
We ordinarily publish a notice of proposed rulemaking in the
None of the above processes or effective date requirements apply, however, when the rule in question is interpretive, a general statement of policy, or a rule of agency organization, procedure or practice. They also do not apply when the Congress itself has created the rules that are to be applied, leaving no discretion or gaps for an agency to fill in through rulemaking.
In addition, an agency may waive notice and comment rulemaking, as well as any delay in effective date, when the agency for good cause finds that notice and public comment on the rule as well the effective date delay are impracticable, unnecessary, or contrary to the public interest. In cases where an agency finds good cause, the agency must incorporate a statement of this finding and its reasons in the rule issued.
The policies being publicized in this notice do not constitute agency rulemaking. Rather, the Congress, in the MMEA, has already required that the agency make these changes, and we are simply notifying the public of certain required revisions to wage index values that are effective either October 1, 2010 (or for certain affected non-508 hospitals April 1, 2011). As this notice merely informs the public of these required modifications to the wage index values under the IPPS, it is not a rule and does not require any notice and comment rulemaking. To the extent any of the policies articulated in this notice constitute interpretations of the Congress's requirements or procedures that will be used to implement the Congress's directive; they are interpretive rules, general statements of policy, and/or rules of agency procedure or practice, which are not subject to notice-and-comment rulemaking or a delayed effective date.
However, to the extent that notice and comment rulemaking or a delay in effective date or both would otherwise apply, we find good cause to waive such requirements. Specifically, we find it unnecessary to undertake notice and comment rulemaking in this instance as this notice does not propose to make any substantive changes to IPPS policies or methodologies already in effect as a matter of law, but simply applies rate adjustments required by MMEA to these existing policies and methodologies. Therefore, we would be unable to change any of the policies governing the IPPS for FY 2011 in response to public comment on this notice. Finally, even if any of the policies could be subject to change, as many of the changes outlined in this notice have already taken effect or must take effect within a very short period of time after enactment of the MMEA (that is, by April 1, 2011—approximately 3 months after enactment), it would also be impracticable to undertake notice and comment rulemaking. For these reasons, we also find that a waiver of any delay in effective date, if it were otherwise applicable, is necessary to comply with the requirements of the MMEA. Therefore, we find good cause to waive notice and comment procedures as well as any delay in effective date, if such procedures or delays are required at all.
We have examined the impacts of this notice as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993), Executive Order 13563 on Improving Regulation and Regulatory Review (January 18, 2011), the Regulatory Flexibility Act (RFA) (September 19, 1980, Pub. L. 96-354), section 1102(b) of the Social Security Act, section 202 of the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
Executive Orders 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits
The RFA requires agencies to analyze options for regulatory relief of small businesses, if a rule has a significant impact on a substantial number of small entities. For purposes of the RFA, small entities include small businesses, nonprofit organizations, and small government jurisdictions. We estimate that most hospitals and most other providers and suppliers are small entities as that term is used in the RFA. The great majority of hospitals and most other health care providers and suppliers are small entities, either by being nonprofit organizations or by meeting the SBA definition of a small business (having revenues of less than $7.5 to $34.5 million in any 1 year). (For details on the latest standard for health care providers, we refer readers to page 33 of the Table of Small Business Size Standards at the Small Business Administration's Web site at
In addition, section 1102(b) of the Act requires us to prepare a regulatory impact analysis if a rule may have a significant impact on the operations of a substantial number of small rural hospitals. This analysis must conform to the provisions of section 604 of the RFA. With the exception of hospitals located in certain New England counties, for purposes of section 1102(b) of the Act, we now define a small rural hospital as a hospital that is located outside of an urban area and has fewer than 100 beds. Section 601(g) of the Social Security Amendments of 1983 (Pub. L. 98-21) designated hospitals in certain New England counties as belonging to the adjacent urban area. Thus, for purposes of the IPPS, we continue to classify these hospitals as urban hospitals.
Section 202 of the Unfunded Mandates Reform Act of 1995 (UMRA) (Pub. L. 104-4) also requires that agencies assess anticipated costs and benefits before issuing any rule whose mandates require spending in any 1 year of $100 million in 1995 dollars, updated annually for inflation. In 2011, that threshold is approximately $136 million. This notice will not mandate any requirements for State, local, or Tribal governments, nor will it affect private sector costs. Executive Order 13132 establishes certain requirements that an agency must meet when it promulgates a proposed rule (and subsequent final rule) that imposes substantial direct requirement costs on State and local governments, preempts State law, or otherwise has Federalism implications. This notice will not have a substantial effect on State and local governments.
Although this notice merely reflects the implementation of provisions of the MMEA and does not constitute a substantive rule, we are nevertheless preparing this impact analysis in the interest of ensuring that the impacts of these changes are fully understood. The following analysis, in conjunction with the remainder of this document, demonstrates that this notice is consistent with the regulatory philosophy and principles identified in Executive Order 12866 and 13563, the RFA, and section 1102(b) of the Act. The notice will positively affect payments to a substantial number of small rural hospitals, as well as other classes of hospitals, and the effects on some hospitals may be significant. The impact analysis, which shows the effect on all payments to hospitals, is shown in Table I of this notice.
This notice is necessary to update the final fiscal year (FY) 2011 wage indices and hospital reclassifications and other related tables to reflect changes required by or resulting from the implementation of section 102 of the MMEA. MMEA requires the extension of the expiration date for certain geographic reclassifications and special exception wage indices through September 30, 2011. We note that the changes in this notice are already in effect with changes made to PRICER and announced through a Joint Signature Memorandum.
The FY 2011 IPPS final rule included an impact analysis for the changes to the IPPS included in that rule. This notice updates those impacts to the IPPS operating payment system as to reflect certain changes required by the MMEA. Because provisions in the MMEA were not budget neutral, the overall estimates for hospitals have changed from our estimate that was published in the FY 2011 IPPS final rule (75 FR 50042). We estimate that the changes in the FY 2011 IPPS final rule, in conjunction with the final IPPS rates and wage index included in this notice, will result in an approximate $279 million decrease in total operating payments relative to FY 2010. In the FY 2011 IPPS final rule (75 FR 50042), we had projected that total operating payments would decrease by $440 million relative to FY 2010. However, the changes in this notice will increase operating payments by $162 million relative to what was projected in the FY 2011 IPPS final rule, resulting in a net decrease of $279 million in total operating payments. Capital payments are estimated to increase by an additional $13.6 million in FY 2011 as a result of the changes in this notice.
In Table I, we provide an impact analysis for changes to the IPPS operating payments in FY 2011 as a result of the changes required by the MMEA. The table categorizes hospitals by various geographic and special payment consideration groups to illustrate the varying impacts on different types of hospitals. The first row of Table I shows the overall impact on the 3,472 acute care hospitals included in the analysis. The impact analysis reflects the change in estimated operating payments in FY 2011 due to the provisions in the MMEA relative to estimated FY 2011 operating payments published in the FY 2011 IPPS final rule (75 FR 50042). Overall, all hospitals will experience an estimated 0.2 percent increase in operating payments in FY 2011 due to the provisions in MMEA compared to the previous estimates of operating payments in FY 2011 published in the FY 2011 IPPS final rule. Because the provisions in the MMEA were not budget neutral, all hospitals, depending on whether they were affected by the provisions in the MMEA, will either experience no
This notice provides descriptions of the statutory provisions that are addressed and identifies policies for implementing these provisions. Due to the prescriptive nature of the statutory provisions, no alternatives were considered.
As required by OMB Circular A-4 (available at
This addendum includes tables referred to throughout the notice which contain data relating to the final FY 2010 wage indices and the hospital reclassifications and payment amounts for operating costs discussed in section II. of this notice.
The following providers have been removed from Table 9A published in the FY 2011 IPPS/LTCH final rule (or in the October 1, 2010 correction notice to that final rule) due to the implementation of section 102 of the MMEA:
Food and Drug Administration, HHS.
Notice of conference.
The Food and Drug Administration (FDA) is announcing the following conference: 14th Annual Educational Conference co-sponsored with the Orange County Regulatory Affairs Discussion Group (OCRA). The conference is intended to provide the drug, device, biologics, and dietary supplement industries with an opportunity to interact with FDA reviewers and compliance officers from the centers and District Offices, as well as from other industry experts. The main focus of this interactive conference will be product approval, compliance, and risk management in the three medical product areas. Industry speakers, interactive Q & A, and workshop sessions will also be included to assure open exchange and dialogue on the relevant regulatory issues.
Before May 1, 2011, registrations fees are as follows: $675.00 for members, $725.00 for non-members and $475.00 for FDA/Government/Students.* After May 1, 2011, $725.00 for members, $775.00 for non-members, and $475.00 for FDA/Government/Students.*
* OCRA student rate applies to those individuals enrolled in a regulatory or quality-related academic program at an accredited institution. Proof of enrollment required.
The registration fee will cover actual expenses including refreshments, lunch, materials, parking, and speaker expenses.
If you need special accommodations due to a disability, please contact Linda Hartley (
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the FD&C Act) debarring
This order is effective April 7, 2011.
Submit applications for termination of debarment to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
Kenny Shade, Office of Regulatory Affairs (HFC-230), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-796-4640.
Section 306(b)(2)(B)(i)(I) of the FD&C Act (21 U.S.C. 335a(b)(2)(B)(i)(I)) permits FDA to debar an individual if it finds that the individual has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and if FDA finds that the type of conduct that served as the basis for the conviction undermines the process for the regulation of drugs.
On March 14, 2006, Cathryn Lyn Chatman (also known as Cathryn Lyn Garcia) pleaded guilty to a misdemeanor offense of misbranding a drug. On August 14, 2006, the United States District Court for the District of Oregon entered judgment against Ms. Chatman for misdemeanor misbranding a drug, in violation of 21 U.S.C. 331(k) and 333(a)(1).
FDA's finding that debarment is appropriate is based on the misdemeanor conviction referenced herein. The factual basis for the conviction is as follows: Ms. Chatman was a registered nurse licensed by the Oregon Board of Nursing. Throughout 2004, she assisted a codefendant in operating two clinics that offered treatments they claimed could combat the effects of aging, including injection with BOTOX. From August 2004 through December 2004, Ms. Chatman offered a botulinum toxin called “Refinex” for sale for injection to patients under the name of another drug, BOTOX. Refinex is manufactured by the Shandong Bioresearch Institute in the People's Republic of China and has never been approved or licensed by FDA for any use. Ms. Chatman misbranded a drug, namely botulinum toxin type A manufactured by Shandong Bioresearch Institute and known as Refinex, while it was held for sale and after shipment in interstate commerce, in that she offered Refinex for sale by injection to patients under the name of another drug that is approved, namely BOTOX, all in violation of 21 U.S.C. 331(k) and 333(a)(1).
As a result of her conviction, on January 5, 2011, FDA sent Ms. Chatman a notice by certified mail proposing to debar her for 5 years from providing services in any capacity to a person that has an approved or pending drug product application. The proposal was based on a finding, under section 306(b)(2)(B)(i)(I) of the FD&C Act, that Ms. Chatman was convicted of a misdemeanor under Federal law for conduct relating to the regulation of drug products under the FD&C Act, and that the conduct that served as a basis for the conviction undermines the process for the regulation of drugs. The proposal also offered Ms. Chatman an opportunity to request a hearing, providing her 30 days from the date of receipt of the letter in which to file the request, and advised her that failure to request a hearing constituted a waiver of the opportunity for a hearing and of any contentions concerning this action. Ms. Chatman failed to respond within the timeframe prescribed by regulation and has, therefore, waived her opportunity for a hearing and waived any contentions concerning her debarment (21 CFR part 12).
Therefore, the Director, Office of Enforcement, Office of Regulatory Affairs, under section 306(b)(2)(B)(i)(I) of the FD&C Act, under authority delegated to him (Staff Manual Guide 1410.35), finds that Cathryn Lyn Chatman has been convicted of a misdemeanor under Federal law for conduct relating to the regulation of a drug product under the FD&C Act, and that the type of conduct that served as a basis for the conviction undermines the process for the regulation of drugs.
As a result of the foregoing finding, Ms. Chatman is debarred for 5 years from providing services in any capacity to a person with an approved or pending drug product application under sections 505, 512, or 802 of the FD&C Act (21 U.S.C. 355, 360b, or 382), or under section 351 of the Public Health Service Act (42 U.S.C. 262), effective (see
Publicly available submissions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
Food and Drug Administration, HHS.
Notice.
This notice announces a forthcoming meeting of a public advisory committee
FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at
Persons attending FDA's advisory committee meetings are advised that the Agency is not responsible for providing access to electrical outlets.
FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Nicole Vesely at least 7 days in advance of the meeting.
FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at
Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).
Food and Drug Administration, HHS.
Notice of public meeting.
The Food and Drug Administration (FDA) is announcing a public meeting to discuss the safety and efficacy of drugs for the treatment of insomnia. The Division of Neurology Products (DNP) in FDA's Center for Drug Evaluation and Research and the Pharmaceutical Education and Research Institute (PERI) are cosponsoring the 2-day meeting, with the first day centered on issues of efficacy and the second day on safety.
A registration fee will be charged to help defray the costs of rental of the meeting spaces, meals and snacks provided, and to cover travel costs incurred by invited speakers, and other costs. The cost of registration is as follows:
Registration fees will be waived for invited speakers and members of the working group. If you need special accommodations due to a disability, please contact Margaret Bogie or Cathleen Michaloski (see
Insomnia is a common disorder in the United States, yet it remains relatively poorly understood. Questions remain, for example, about the definition of insomnia and the classification of patients with the disorder. A better understanding of insomnia should help lead to safer and more effective treatment. A number of medications have been approved for insomnia, and many experimental medications are currently in development. New concerns have arisen about the most appropriate way to evaluate both the safety and the efficacy of medications for insomnia, particularly given that they may differ in important characteristics, including both pharmacodynamic and pharmacokinetic properties.
DNP and PERI plan for the first day of the meeting to center on issues of efficacy, including the evolving definition of insomnia, the classification of patients with this disorder, and the measurement of clinically relevant outcomes, including the choice of endpoints, subjective versus objective assessments, and duration of effect. The second day of the meeting will center on safety issues of hypnotic drugs, including the nature and prevalence of adverse events (AEs) related to the use of hypnotic drugs and evaluation of these AEs with a concentration on psychovigilance testing and driving-related tests.
Additional information on the conference, program, and registration procedures is available on the Internet at
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) has reorganized the Center for Drug Evaluation and Research (CDER), Office of Surveillance and Epidemiology (OSE). This reorganization includes the organizations and their substructure components as listed in this document. This reorganization includes the establishment of six Staffs: Executive Operations and Strategic Planning Staff, Regulatory Science Staff, Regulatory Affairs Staff, Program Management and Analysis Staff, Project Management Staff, and Technical Information Staff. It will also include Office of Medication Error Prevention and Risk Management (OMEPRM) and Office of Pharmacovigilance and Epidemiology (OPE) under OSE. OMEPRM will consist of the Division of Risk Management and the Division of Medication Error Prevention and Analysis. OPE will consist of the Division of Epidemiology I and Division of Epidemiology II and the Division of Pharmacovigilance I and Division of Pharmacovigilance II. Also included are the abolishment of Business Process Improvement Staff, Regulatory Policy Staff, and Review Management Staff within OSE Immediate Office.
Karen Koenick, Center for Drug Evaluation and Research (HFD-063), Food and Drug Administration,11919 Rockville Pike, rm. 324, Rockville, MD 20852, 301-796-4422.
The Statement of Organization, Functions, and Delegations of Authority for the Department of Health and Human Services (35 FR 3685, February 25, 1970; 60 FR 56605, November 9, 1995; 64 FR 36361, July 6, 1999; and 72 FR 50112, August 30, 2007) is amended to reflect the restructuring of CDER, FDA as follows.
CDER is headed by the Director, and includes the following organizational unit:
1. Provides leadership, direction, planning, budgeting, management, and supervision of Divisions and Staffs; and premarketing and postmarketing risk assessment program operations.
2. Develops and maintains international and national contact with regulators.
3. Develops, coordinates, and implements postmarket risk assessment policy, guidance, and interpretations.
4. Initiates regulation development and enhancement.
5. Coordinates and implements policies and initiatives, including information management initiatives across the Agency.
1. Provides leadership, direction, and coordination for OSE regulatory research activities.
2. Develops and manages relationships with outside scientific groups that interface with OSE scientists on a variety of projects that relate to OSE's drug safety mission. These outside groups include academic organizations, private organizations, and other Federal Agencies.
3. Coordinates the access to large databases for pharmacoepidemiologic and pharmacovigilance studies, as well as to the outside scientists with drug safety expertise to collaborate with CDER.
4. Develops regulatory research programs that will support OSE as a whole, including risk management, pharmacovigilance, and medication error detection and prevention; in addition to epidemiology.
1. Responsible for the coordination and implementation of regulatory policies by staff within OSE by coordinating the development and upkeep of guidances, MAPPs, and standard operating procedures, answering regulatory questions, managing the process for waivers of
2. Provides leadership on initiatives related to the Medical Dictionary for Regulatory Activities (MedDRA).
1. Creates and maintains professional and skills training programs for OSE personnel.
2. Plans and tracks goals and objectives of all OSE Offices and Divisions.
3. Evaluates OSE work products and communications using quality control technology.
4. Interacts with Executive Secretariat, Press Office, and etc.
1. Provides coordination, development and assessment of policies, procedures, and best practices related to OSE data and information system management within OSE.
2. Provides representation for OSE on Center and Agency best practices boards associated with staff responsibilities.
3. Represents OSE in Center and Agency boards or workgroups that address business process improvements and information technology related to postmarket drug safety.
4. Ensures that OSE's informatics systems (
1. Provides leadership, direction, planning, budgeting, management, and supervision of programs related to the OSE office administration and contracts management.
2. Provides guidance and support services to the OSE on all aspects of administrative, budget, and facilities management and provides service and support on human resource, personnel operations services, and recruitment activities.
3. Provides management, tracking and facilitation of projects related to office administration and contracts management within OSE.
4. Provides coordination, development, and assessment of policies, procedures, and best practices related to OSE office administration and contract management within OSE.
5. Provides representation for OSE on center and Agency best practices boards associated with staff responsibilities.
1. Provides leadership, direction, planning, management, and supervision of programs related to drug safety reviews and staff.
2. Provides management, tracking, and facilitation of projects related to drug safety reviews within OSE.
3. Provides coordination, development, and assessment of policies and procedures related to drug safety reviews, review templates, and other best practices related to drug safety reviews within OSE.
4. Provides representation for OSE on Center best practices associated with staff responsibilities.
1. Directs and supports the Divisions of Medication Error Prevention and Analysis and Risk Management.
2. Leads OSE review of proposed and implemented Risk Minimization Action Plans (RiskMAPs)/Risk Evaluation and Mitigation Strategies (REMS).
3. Coordinates risk communication components of drug safety risk management programs.
4. Coordinates reviews of proposed proprietary trade names for their potential to result in sound-alike or look-alike medication errors.
5. Performs root-cause analyses of postmarketing medication error reports.
1. Plans, directs, and provides information technology support to the OSE.
2. Develops and maintains necessary software, processes, procedures, training, and security or databases available to OSE.
3. Acts as focal point for all hardware, software, and other information systems issues.
4. In conjunction with the OSE programs, evaluates extant information resources for utility and value to the OSE missions. Arranges for necessary accesses, training, and other needs related to effective use of those resources.
5. Develops and maintains the OSE Center for Drug Evaluation and Research Network (CDERNET) Web pages and works with other Agency programs to develop and maintain Internet pages related to office programs.
6. Serves as the primary OSE contact for World Health Organization (WHO) searches, Freedom of Information (FOI) and National Technical Information Services (NTIS) issues, and for database searches.
7. Reviews proposed proprietary trade names for their potential to result in sound-alike or look-alike medication errors.
8. Analyzes and performs root-cause analyses of postmarketing medication error reports.
9. Develops and implements internal MAPPs and guidance on medication error and patient safety initiatives.
1. Plans and directs all risk management activities in the OSE.
2. Provides risk management expertise to OSE and the center.
3. Reviews all proposed Risk Minimization Action Plans (RiskMAPs) or Risk Management Plans (RMPs) for conformance with FDA's standards.
4. Conducts postmarketing monitoring of all products with approved RiskMAPs.
5. Conducts evaluations of the performance of RiskMAPs.
6. In conjunction with Office of New Drugs (OND), conducts premarketing risk assessments for some products.
7. Helps develop and maintain the Agency's OSE CDERNET RiskMAP Web pages and works with other Agency programs to develop and maintain RiskMAP Internet pages.
8. Develops and implements internal MAPPs and guidance on risk management initiatives.
1. Directs and supports the Divisions of Pharmacovigilance and Epidemiology.
2. Evaluates the safety of marketed drugs.
3. Reviews adverse event reports with OND.
4. Collaborates with other offices to recommend appropriate actions.
5. Provides recommendations on risk management programs and REMS.
6. Coordinates the review and analysis of epidemiologic study protocols and results of epidemiologic studies submitted by industry, from the literature or other sources that are related to the postmarketing safety of drugs.
1. Provides leadership, direction, planning, budgeting, management, and supervision of Division programs and staff.
2. Reviews and provides analyses of epidemiologic study protocols and results of epidemiologic studies submitted by industry, from the literature or other sources that are related to the postmarketing safety of drugs.
3. Provides development and assessment of methodologies and best practices for active and passive surveillance systems and for incorporating such data, when appropriate, into the review of the postmarketing safety of drugs.
4. Reviews and analyzes drug utilization information.
5. Performs epidemiologic research on drug safety issues.
6. Provides epidemiologic and drug utilization expertise to support medical review divisions in areas of responsibility, as well as, for Advisory Committee presentations and related documents.
7. Provides input on epidemiologic and drug utilization aspects of information for the public related to significant postmarketing safety information regarding drugs, biologics, devices, and foods.
8. Develops and implements internal MAPPs and guidance on epidemiologic and drug utilization initiatives.
1. Provides leadership, direction, planning, budgeting, management, and supervision of Division programs and staff.
2. Reviews and analyzes epidemiologic study protocols and results of epidemiologic studies submitted by industry from the literature or other sources that are related to the postmarketing safety of drugs.
3. Provides for the development and assessment of methodologies and best practices for scientifically-sound observational studies related to postmarketing safety of drugs.
4. Reviews and analyzes drug utilization information.
5. Performs epidemiologic research on drug safety issues.
6. Provides epidemiologic and drug utilization expertise to support medical review divisions in areas of responsibility, as well as, for Advisory Committee presentations and related documents.
7. Provides input on epidemiologic and drug utilization aspects of information for the public related to significant postmarketing safety information regarding drugs, biologics, devices, and foods.
8. Develops and implements internal MAPPs and guidance on epidemiologic and drug utilization initiatives.
1. Provides leadership, direction, planning, budgeting, management, and supervision of Division programs and staff.
2. Reviews and provides analysis of adverse event reports from industry submissions and from reports submitted directly to FDA related to marketed drugs in order to detect safety signals and evaluate risk; and performs followup when such signals are detected.
3. Provides development and assessments of methodologies and best practices for scientifically-sound safety signal detection and drug risk evaluation related to the postmarketing safety of drugs.
4. Provides safety signal detection and drug risk evaluation support to medical review divisions in areas of responsibility, as well as, for Advisory Committee presentations.
5. Provides recommendations on safety signal detection and drug risk evaluation aspects of proposed and implemented RiskMAPs or RMPs.
6. Provides input on signal detection and drug risk evaluation included in information for the public related to significant safety information regarding drugs, biologics, devices, and foods.
7. Develops and implements internal MAPPs and guidance on safety signal detection and drug risk evaluation initiatives.
1. Provides leadership, direction, planning, budgeting, management, and supervision of Division programs and staff.
2. Reviews and provides analyses of adverse event reports from industry submissions and from reports submitted directly to FDA related to marketed drugs in order to detect safety signals and evaluate risk; performs followup when such signals are detected.
3. Provides development and assessment of methodologies and best practices for scientifically-sound safety signal detection and drug risk evaluation related to the postmarketing safety of drugs.
4. Provides safety signal detection and drug risk evaluation support to medical review divisions in areas of responsibility, as well as, for Advisory Committee presentations.
5. Provides recommendations on safety signal detection and drug risk evaluation aspects of proposed and implemented RiskMAPs or RMPs.
6. Provides input on signal detection and drug risk evaluation included in information for the public related to significant safety information regarding drugs, biologics, devices, and foods.
7. Develops and implements internal MAPPs and guidance on safety signal detection and drug risk evaluation initiatives.
Pending further delegation, directives or orders by the Commissioner of the Food and Drugs or the Center Director, CDER, all delegations and redelegations of authority made to officials and employees of affected organizational components will continue in them or their successors pending further redelegations, provided they are consistent with this reorganization.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Center for Scientific Review Advisory Council.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App), notice is hereby given of the National Advisory Council for Complementary and Alternative Medicine (NACCAM) meeting.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and/or contract Proposals and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications and/or contract proposals, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
The public comments session is scheduled from 3:30 to 4 p.m. on June 3, 2011, but could change depending on the actual time spent on each agenda item. Each speaker will be permitted 5 minutes for their presentation. Interested individuals and representatives of organizations are requested to notify Dr. Martin H. Goldrosen, National Center for Complementary and Alternative Medicine, NIH, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland, 20892, 301-594-2014,
Copies of the meeting agenda and the roster of members will be furnished upon request by contacting Dr. Martin H. Goldrosen, Executive Secretary, NACCAM, National Center for Complementary and Alternative Medicine, National Institutes of Health, 6707 Democracy Boulevard, Suite 401, Bethesda, Maryland 20892, 301-594-2014, Fax 301-480-9970, or via e-mail at
In the interest of security, NIH has instituted stringent procedures for entrance onto the NIH campus. All visitor vehicles, including taxicabs, hotel, and airport shuttles will be inspected before being allowed on campus. Visitors will be asked to show one form of identification (for example, a government-issued photo ID, driver's license, or passport) and to state the purpose of their visit.
Information is also available on the Institute's/Center's home page:
In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 concerning opportunity for public comment on proposed collections of information, the Substance Abuse and Mental Health Services Administration (SAMHSA) will publish periodic summaries of proposed projects. To request more information on the proposed projects or to obtain a copy of the information collection plans, call the SAMHSA Reports Clearance Officer on (240) 276-1243.
Comments are invited on: (a) Whether the proposed collections of information are necessary for the proper performance of the functions of the agency, including whether the information shall have practical utility; (b) the accuracy of the agency's estimate of the burden of the proposed collection of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques or other forms of information technology.
The National Survey on Drug Use and Health (NSDUH) is a survey of the civilian, non-institutionalized population of the United States 12 years old and older. The data are used to determine the prevalence of use of tobacco products, alcohol, illicit substances, and illicit use of prescription drugs. The results are used by SAMHSA, ONDCP, Federal government agencies, and other organizations and researchers to establish policy, direct program activities, and better allocate resources.
The 2012 and 2013 NSDUHs will continue conducting a follow-up clinical interview with a subsample of approximately 1,500 respondents. The design of this Mental Health Surveillance Study (MHSS) is based on the recommendations from a panel of expert consultants convened by the Center for Mental Health Services (CMHS), SAMHSA, to discuss mental health surveillance data collection strategies. The goal is to create a statistically sound measure that may be used to estimate the prevalence of Serious Mental Illness (SMI) among adults (age 18+).
For the 2012 and 2013 NSDUHs, no questionnaire changes are proposed.
As with all NSDUH/NHSDA surveys conducted since 1999, the sample size of the survey for 2012 and 2013 will be sufficient to permit prevalence estimates for each of the fifty states and the District of Columbia. The total annual burden estimate is shown below:
Send comments to Summer King, SAMHSA Reports Clearance Officer, Room 8-1099, One Choke Cherry Road, Rockville, MD 20857
Coast Guard, DHS.
Notice.
The Coast Guard announces the date for the entry into effect of discharge requirements from ships in the Wider Caribbean Region (WCR) special area (SA) as specified in the International Convention for the Prevention of Pollution from Ships (MARPOL) Annex V, Regulation 5 and Coast Guard regulations. MARPOL Annex V and the U.S. regulations apply to vessel and reception facility activities in the WCR region.
IMO Resolution MEPC.191(60) established the date of entry for discharge requirements in the WCR SA as May 1, 2011.
The docket for this notice is 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. You may also find this docket on the Internet by going
If you have questions about this notice, call or e-mail Mr. David Condino, MARPOL Certificate of Adequacy Project Manager, telephone: 202-372-1145, e-mail: david.a.condino@uscg.mil; or LCDR Kevin P. Lynn, Chief, Facility Safety Branch, Commandant, CG-5442, telephone: 202-372-1130, e-mail: kevin.p.lynn@uscg.mil. If you have questions on viewing material in the docket, call Renee V. Wright, Program Manager, Docket Operations, telephone: 202-366-9826.
Under Coast Guard regulation 33 CFR 151.53(b), the Coast Guard announces the May 1, 2011 date for entry into effect of discharge requirements from ships in the WCR SA. The WCR is defined in 33 CFR 151.06(a)(12). As of May 1, 2011, the discharge restrictions for SAs set forth in 33 CFR 151.71 will be applicable to the WCR SA.
In accordance with the provisions of regulation 5(4)(b) found in MARPOL Annex V, the United States, along with a sufficient number of WCR States that are parties to MARPOL, submitted notices on the availability of adequate reception facilities in the region to the International Maritime Organization's (IMO) Marine Environment Protection Committee (MEPC) at a meeting of the MEPC in March, 2010. During the meeting the WCR States requested that the MEPC establish a date for the entry into effect of the WCR SA. The MEPC noted the information provided by Member States in the WCR SA, to include the United States, and decided that the requirements for sufficient notification of adequate reception facilities for the WCR SA had been met. The MEPC adopted resolution MEPC.191(60) and the IMO Secretariat transmitted the text of the resolution to all interested parties via Circular Letter No.3053 dated April 14, 2010. These documents are available on the IMO's Web site at
As a party to MARPOL Annex V, the United States proposed to the IMO's MEPC to establish the Gulf of Mexico as an SA under MARPOL Annex V in September 1990. The country of Venezuela submitted an amendment to the proposal to include the WCR along with the Gulf of Mexico as an SA under MARPOL Annex V in November 1990. The MEPC adopted the proposal to establish the WCR SA, including the Gulf of Mexico and the Caribbean Sea, in July 1991. The SA entered into force in April 1993, and MARPOL Annex V discharge requirements for the SA will enter into effect May 1, 2011. When the discharge requirements in regulation 5 of MARPOL Annex V enter into effect for the WCR SA, the discharge restrictions in 33 CFR 151.71 will also enter into effect. These regulations state that no person may discharge garbage from a ship except food wastes. The disposal of food wastes into the sea shall be made as far as practicable from land, but in any case not less than 12 nautical miles from the nearest land. Food wastes comminuted or ground and capable of passing through a screen with openings no greater than 25 mm may be discharged not less than 3 nautical miles from the nearest land.
The Coast Guard intends to update the list of SAs, in accordance with 33 CFR 151.53(b), to include where discharge restrictions are effective in a separate rule change.
Office of the Assistant Secretary for Public and Indian Housing, HUD.
Notice.
In accordance with the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-05, approved February 17, 2009) (Recovery Act), and implementing guidance of the Office of Management and Budget (OMB), this notice advises that certain exceptions to the Buy American requirement of the Recovery Act have been determined applicable for work using Capital Fund Recovery Formula and Competition (CFRFC) grant funds. Specifically, exceptions were granted to the Cambridge Housing Authority of Cambridge, MA for the purchase and installation of energy efficient hot water baseboards at the Cambridge Affordable Presidential Apartments, the Housing Authority of the City of Bowling Green in Bowling Green Missouri for the purchase and installation of dual flush toilets at the Bowling Green High Rise Apartments. An exception was also granted to the Housing Authority of the City of Runge in Runge, Texas, for the purchase and installation of ceiling fans in eleven scattered sites.
Donald J. LaVoy, Deputy Assistant Secretary for Office of Field Operations, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 7th Street, SW., Room 4112, Washington, DC 20410-4000, telephone number 202-402-8500 (this is not a toll-free number); or Dominique G. Blom, Deputy Assistant Secretary for Public Housing Investments, Office of Public Housing Investments, Office of Public and Indian Housing, Department of Housing and Urban Development, 451 7th Street, SW., Room 4130, Washington, DC 20410-4000, telephone number 202-402-8500 (this is not a toll-free number). Persons with hearing- or speech-impairments may access this number through TTY by calling the toll-free Federal Information Relay Service at 800-877-8339.
Section 1605(a) of the Recovery Act provides that none of the funds appropriated or made available by the Recovery Act may be used for a project for the construction, alteration, maintenance, or repair of a public building or public work unless all of the iron, steel, and manufactured goods used in the project are produced in the United States. Section 1605(b) provides that the Buy American requirement shall not apply in any case or category in which the head of a Federal department or agency finds that: (1) Applying the Buy American requirement would be inconsistent with the public interest; (2) iron, steel, and the relevant manufactured goods are not produced in the U.S. in sufficient and reasonably available quantities or of satisfactory quality, or (3) inclusion of iron, steel, and manufactured goods will increase the cost of the overall project by more than 25 percent. Section 1605(c) provides that if the head of a Federal department or agency makes a determination pursuant to section 1605(b), the head of the department or agency shall publish a detailed written justification in the
In accordance with section 1605(c) of the Recovery Act and OMB's implementing guidance published on April 23, 2009 (74 FR 18449), this notice advises the public that, on March 17, 2011, the following exceptions were granted:
Office of Surface Mining Reclamation and Enforcement, Interior
Notice and request for comments for 1029-0091.
In compliance with the Paperwork Reduction Act of 1995, the Office of Surface Mining Reclamation and Enforcement (OSM) is announcing its intention to request continued approval for the collection of information under 30 CFR Part 750 which relates to surface coal mining and reclamation operations on Indian Lands.
Comments on the proposed information collection must be received by June 6, 2011.
Comments may be mailed to John Trelease, Office of Surface Mining Reclamation and Enforcement, 1951 Constitution Ave., NW., Room 202—SIB, Washington, DC 20240. Comments may also be submitted electronically to
To receive a copy of the information collection request contact John Trelease at (202) 208-2783 or by e-mail at
The Office of Management and Budget (OMB) regulations at 5 CFR 1320, which implement provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), require that interested members of the public and affected agencies have an opportunity to comment on information collection and recordkeeping activities [
An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control number for part 750 is 1029-0091. Responses are required to obtain a benefit.
Before including your address, phone number, email address, or other personal identifying information in your comment, you should be aware that your entire comment, including your personal identifying information, may be made publicly available at any time. While you can ask us in your comment to withhold your personal identifying information from public review, we cannot guarantee that we will be able to do so.
The following information is provided for the information collection: (1) Title of the information collection; (2) OMB control number; (3) summary of the information collection activity; and (4) frequency of collection, description of the respondents, estimated total annual responses, and the total annual reporting and recordkeeping burden for the collection of information.
Operators who conduct or propose to conduct surface coal mining and reclamation operations on Indian lands must comply with the requirements of 30 CFR 750 pursuant to Section 710 of SMCRA.
United States International Trade Commission.
Institution of antidumping and countervailing duty investigations and scheduling of preliminary phase investigations.
The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping and countervailing Investigation Nos. 701-TA-479 and 731-TA-1183-1184 (Preliminary) under sections 703(a) and 733(a) of the Tariff Act of 1930 (19 U.S.C. 1671b(a) and 1673b(a)) (the Act) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of
For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).
Angela Newell (202-708-5409), Office of Investigations, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.12 of the Commission's rules.
By order of the Commission.
United States International Trade Commission.
Institution of antidumping investigations and scheduling of preliminary phase investigations.
The Commission hereby gives notice of the institution of investigations and commencement of preliminary phase antidumping investigation Nos. 731-TA-1186-1187 (Preliminary) under section 733(a) of the Tariff Act of 1930 (19 U.S.C. 1673b(a)) (the Act) to determine whether there is a reasonable indication that an industry in the United States is materially injured or threatened with material injury, or the establishment of an industry in the United States is materially retarded, by reason of imports from China and Taiwan of certain stilbenic optical brightening agents, provided for in subheading 3204.20.80 of the Harmonized Tariff Schedule of the United States, that are alleged to be sold in the United States at less than fair
For further information concerning the conduct of these investigations and rules of general application, consult the Commission's Rules of Practice and Procedure, part 201, subparts A through E (19 CFR part 201), and part 207, subparts A and B (19 CFR part 207).
Cynthia Trainor (202-205-3354), Office of Investigations, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436. Hearing-impaired persons can obtain information on this matter by contacting the Commission's TDD terminal on 202-205-1810. Persons with mobility impairments who will need special assistance in gaining access to the Commission should contact the Office of the Secretary at 202-205-2000. General information concerning the Commission may also be obtained by accessing its Internet server (
In accordance with sections 201.16(c) and 207.3 of the rules, each document filed by a party to the investigations must be served on all other parties to the investigations (as identified by either the public or BPI service list), and a certificate of service must be timely filed. The Secretary will not accept a document for filing without a certificate of service.
These investigations are being conducted under authority of title VII of the Tariff Act of 1930; this notice is published pursuant to section 207.12 of the Commission's rules.
By order of the Commission.
U.S. International Trade Commission.
Notice.
Notice is hereby given that the U.S. International Trade Commission has received a complaint entitled
James R. Holbein, Acting Secretary to the Commission, U.S. International Trade Commission, 500 E Street, SW., Washington, DC 20436, telephone (202) 205-2000. The public version of the complaint can be accessed on the Commission's electronic docket (EDIS) at
The Commission has received a complaint filed on behalf of Ogma, LLC on April 1, 2011. The complaint alleges violations of section 337 of the Tariff Act of 1930 (19 U.S.C. 1337) in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain motion-sensitive sound effects devices and image display devices and components and products containing same. The complaint names as respondents Activision Blizzard Inc. of CA; Apple Inc. of CA; Canon, Inc. of Japan; Canon USA, Inc. of NY; Seiko Epson Corporation of Japan; Epson America, Inc. of CA; HTC Corporation of Taiwan; HTC America, Inc. of WA; InFocus Corp. of OR; Jakks Pacific, Inc. of CA; Kyocera Communications, Inc. of CA; LEGO A/S (dba) LEGO Group of Denmark; LEGO Systems, Inc. of CT; Lenovo (United States), Inc. of NC; Lenovo Group Ltd. of China; Lenovo (Singapore) Pte. Ltd. of Singapore; Mad Catz, Inc. of CA; Motorola Mobility, Inc. of IL; Nintendo Co., Ltd. of Japan; Nintendo of America, Inc. of WA; Nyko Technologies, Inc. of CA; Sanyo North America Corp. of CA; Sanyo Electric Co., Ltd. of Japan; Sanyo Electronic Devices (U.S.A.) of CA; Sharp Corporation of Japan; Sharp Electronics Corporation of NJ; Sony Computer Entertainment America, LLC of CA; Sony Corporation of Japan; Sony Corporation of America of NY; Sony Electronics Inc. of CA; Sony Ericsson Mobile Communications (USA), Inc. of GA; Sony Ericsson Mobile Communications AB of Sweden; Vivitek Corporation of CA; VTech Electronic North America, LLC of IL; VTech Holdings, Ltd. of Hong Kong; ViewSonic Corp., Ltd. of CA; WowWee Group Ltd. of Hong Kong; and WowWee USA, Inc. of CA.
The complainant, proposed respondents, other interested parties, and members of the public are invited to file comments, not to exceed five pages in length, on any public interest issues raised by the complaint. Comments should address whether issuance of an exclusion order and/or a cease and desist order in this investigation would negatively affect the public health and welfare in the United States, competitive conditions in the United States economy, the production of like or directly competitive articles in the United States, or United States consumers.
In particular, the Commission is interested in comments that:
(i) Explain how the articles potentially subject to the orders are used in the United States;
(ii) Identify any public health, safety, or welfare concerns in the United States relating to the potential orders;
(iii) Indicate the extent to which like or directly competitive articles are produced in the United States or are otherwise available in the United States, with respect to the articles potentially subject to the orders; and
(iv) Indicate whether Complainant, Complainant's licensees, and/or third party suppliers have the capacity to replace the volume of articles potentially subject to an exclusion order and a cease and desist order within a commercially reasonable time.
Written submissions must be filed no later than by close of business, five business days after the date of publication of this notice in the
Persons filing written submissions must file the original document and 12 true copies thereof on or before the deadlines stated above with the Office of the Secretary. Submissions should refer to the docket number (“Docket No. 2799”) in a prominent place on the cover page and/or the first page. The Commission's rules authorize filing submissions with the Secretary by facsimile or electronic means only to the extent permitted by section 201.8 of the rules (
Any person desiring to submit a document to the Commission in confidence must request confidential treatment. All such requests should be directed to the Secretary to the Commission and must include a full statement of the reasons why the Commission should grant such treatment.
This action is taken under the authority of section 337 of the Tariff Act of 1930, as amended (19 U.S.C. 1337), and of sections 201.10 and 210.50(a)(4) of the Commission's Rules of Practice and Procedure (19 CFR 201.10, 210.50(a)(4)).
By order of the Commission.
Office of Community Oriented Policing Services, Department of Justice.
30-Day Notice of Information Collection Under Review.
The Department of Justice (DOJ) Office of Community Oriented Policing Services (COPS) will be submitting the following information collection request to the Office of Management and Budget (OMB) for review and approval in accordance with the Paperwork Reduction Act of 1995. The information collection is published to obtain comments from the public and affected agencies. This proposed information collection was previously published in the
The purpose of this notice is to allow for 30 days for public comment until May 9, 2011. This process is conducted in accordance with 5 CFR 1320.10.
If you have comments especially on the estimated public burden or associated response time, suggestions, or need a copy of the proposed information collection instrument with instructions or additional information, please contact Ashley Hoornstra, Department of Justice Office of Community Oriented Policing Services, 145 N Street, NE., Washington, DC 20530.
Written comments concerning this information collection should be sent to the Office of Information and Regulatory Affairs, Office of Management and Budget,
Written comments and suggestions from the public and affected agencies concerning the proposed collection of
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Under 28 CFR 50.7, notice is hereby given that on April 1, 2011, a proposed Consent Decree in
The proposed Consent Decree resolves claims of the United States, on behalf of the Environmental Protection Agency (“EPA”), under the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA”), 42 U.S.C. 9601
The Department of Justice will receive for a period of 30 days from the date of this publication comments relating to the proposed Consent Decree. Comments should be addressed to the Assistant Attorney General of the Environment and Natural Resources Division, Department of Justice, Washington, DC 20530, and either e-mailed to
The proposed Consent Decree may be examined on the following Department of Justice Web site,
On August 10, 2010, Administrative Law Judge (ALJ) John J. Mulrooney, II, issued the attached recommended decision.
Having reviewed the entire record including the ALJ's recommended decision and Respondent's exceptions, I have decided to adopt the ALJ's rulings, findings of fact,
In any event, Respondent offered no evidence on the issue of his experience in dispensing controlled substances and the ALJ's ultimate conclusion that Respondent violated the CSA's prescription requirement because he dispensed controlled substance prescriptions that were not “within `the usual course of [his] professional practice,” ALJ at 33 (quoting 21 CFR 1306.04(a)), and that “the evidence under the [experience] * * * factor[] support[s]” the revocation of his registration, is consistent with Agency precedent.
With respect to factor five, “[s]uch other conduct which may threaten public health and safety,” 21 U.S.C. 823(f)(5), the ALJ opined that “an adverse finding under this factor requires some showing that the relevant conduct
The ALJ also opined that “[i]t is clear that in assessing whether the controlled substance prescribing practices of a Florida practitioner fall within the acceptable range of what constitutes being within the bounds of being `issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice,' resort must be had to an expert.” ALJ at 29 (quoting 21 CFR 1306.04(a)). While the ALJ properly noted the importance of expert testimony in this case, in which the Government primarily relied on a review of the medical charts, whether expert testimony is needed is necessarily dependent on the nature of the allegations and the other evidence in the case. Where, for example, the Government produces evidence of undercover visits showing that a physician knowingly engaged in outright drug deals, expert testimony adds little to the proof necessary to establish a violation of Federal law.
Respondent first takes exception to the ALJ's acceptance of L. Douglas Kennedy, M.D., as an expert on the proper prescribing of controlled substances. Respondent contends that Dr. Kennedy should not have been permitted to opine on his prescribing practices because he does not hold a DEA registration in Florida, has not prescribed a controlled substance since 2004, does not currently have either a medical office or hospital privileges in Florida, and “has never practiced medicine regularly in Florida and has not practiced medicine in Florida at all in over 10 years.” Resp. Exc. at 1.
Respondent's contention is unavailing as Dr. Kennedy was clearly qualified to render an expert opinion on the proper practice for prescribing controlled substances to treat pain and whether Respondent's controlled substance prescriptions were issued in the usual course of professional practice and for a legitimate medical purpose.
Dr. Kennedy has published several articles and book chapters on pain management issues and has made several dozen presentations on pain management issues at professional meetings.
Thus, Dr. Kennedy was clearly qualified to provide expert testimony. I therefore agree with the ALJ that Dr. Kennedy's testimony was sufficiently reliable to constitute substantial evidence on the issue of whether Respondent acted within the usual course of professional practice and had a legitimate medical purpose in prescribing controlled substances to the patients whose files he reviewed and reject this exception.
Next, Respondent contends that Dr. Kennedy's opinion testimony is entitled to no weight because it was based on only seventeen patient charts, which Respondent maintains were not randomly selected and is too small a sample to draw sufficient conclusions about the validity of his prescribing practices. Resp. Exc. at 2. Based on Dr. Kennedy's testimony that “ `[i]t might not be fair' ” to “ `cherry-pick[]' ” a small and non-random sample of charts out of a physician's patients because this might not provide “ `a reasonable representation of what the practice was actually like,' ” Respondent argues that “[e]ven improper prescribing practices reflected in a small and non-random sample of 17 charts * * * may be `an administrative issue for education with the Board of Medical License' ” and not necessarily justify the revocation of Respondent's medical license (or DEA registration).
However, even acknowledging that two of the seventeen files reviewed by Dr. Kennedy with respect to Respondent were not randomly selected (one being that of an undercover officer), the ALJ found credible the Diversion Investigator's testimony that the files were not specially selected to enhance the strength of the Government's case. ALJ at 5 (citing Tr. 768). More importantly, the requirement of Federal law that a prescription “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice,” 21 CFR 1306.04(a), applies to each and every prescription issued by a practitioner. Thus, contrary to the Expert's understanding, in determining whether a practitioner has committed acts which render his registration “inconsistent with the public interest,” 21 U.S.C. 824(a)(4), the Government is not required to randomly select the files which it will base its case on.
For example, where the Government has developed information that particular patients are drug dealers or engaged in self-abuse, it is not required to ignore the files pertaining to these patients and base its case on a random sample of files. Rather, it can select the files pertaining to those patients and base its case entirely on them. Moreover, where the Government has seized files, it can review them and choose to present at the hearing only those files which evidence a practitioner's most egregious acts. Of course, where, as here, the Government's case relies so heavily on a chart review, the practitioner can put on his own evidence and argue that the Government's evidence does not establish that he violated the prescription requirement; the practitioner can also argue that even
Finally, Respondent takes exception to the ALJ's findings that he violated Florida's standards for prescribing controlled substances. Resp. Exceptions at 4-5. More specifically, Respondent contends that he complied with the standards set forth under Florida regulations and that he “took a complete medical history and conducted a physical evaluation that was documented,” that he maintained “medical records documenting the patient's intensity of pain, current and past treatments for pain, and the effect of pain on physical and psychological function.”
While it is true that Dr. Kennedy acknowledged that he was not familiar with the specific standard imposed by the State of Florida for excessive prescribing and that he had not reviewed any Florida Medical Board decisions addressing the issue of what is an adequate medical history,
In any event, Respondent produced no evidence that his recordkeeping and prescribing complied with the standards of the Florida Medical Board. Moreover, there is substantial evidence to support the conclusion that Respondent was not engaged in legitimate medical practice and was diverting drugs.
As Dr. Kennedy explained, the patients whose files he reviewed were relatively young (with an average age of 36), and most were from out-of-state, with some travelling up to 1200 miles,
As Dr. Kennedy explained, while “[t]he chart was set up to give the appearance of a legitimate medical practice in an attempt to justify the initial and continued prescription and dispensing of high dose multiple controlled substances (`drug cocktails'),” and that while “on the surface [the charts] were adequate for evaluating and treating a patient,” on closer review, “the actual contents in the charts, clearly evidence just the opposite” as the charts were “very difficult * * * to read [with] many sections * * * left blank or incompletely filled in.”
The evidence further shows that this case is not simply a matter of inadequate record keeping. While Respondent apparently required his patients to obtain an MRI, in multiple instances the MRI was obtained before the patient was even evaluated by Respondent, and generally, no other imaging studies such as x-rays or CT scans were done.
Moreover, notwithstanding the doses the patients were seeking, Respondent rarely referred a patient to another physician or health care professional for a consultation.
Dr. Kennedy also observed that while Respondent performed urine drug screens, he ignored the results even when they were inconsistent with other information provided by the patients such as when a patient tested positive for controlled substances which he had previously indicated that he was not currently taking.
Although the charts indicate that Respondent discussed doing yoga and stretching, using an anti-inflammatory diet, and taking several over-the-counter supplements (fish oil and glucosamine chondroitin), Respondent's treatment plan primarily involved prescribing high doses of controlled substances with the same regimen of drugs (oxycodone and Xanax) prescribed in nearly every case.
Dr. Kennedy noted that Respondent frequently prescribed “drug cocktails” of two strengths of oxycodone immediate release and a high dose of Xanax, a benzodiazepine.
Dr. Kennedy further noted that while the typical starting dose of Xanax is 0.25 to 0.5 mg., once to twice per day,
Dr. Kennedy further noted that beginning with M.B.'s first visit, Respondent “prescribed very high initial and subsequent high doses of oxycodone and Xanax” and that these drugs “were prescribed excessively and inappropriately without medical justification.”
While M.B. apparently told Respondent that he was taking 210 to 240 oxycodone 30 mg. per month, which he had obtained “off the street,” and he also tested positive for the drug in a urine drug screen (UDS) done at his initial visit, Respondent prescribed 180 Roxicodone 30 mg., 60 Roxicodone 15 mg., and 60 Xanax 2 mg. to M.B. at each of the seven visits he made between August 20, 2009 and February 4, 2010. GX 78, at 7, 9, 13, 18-24.
M.B.'s statement that he was getting “large quantities of oxycodone 30 mg. pills `off the street'” was a clear “warning sign” that he was “at high risk for drug abuse, addiction and/or diversion.” GX 76, at 12;
Finally, Dr. Kennedy explained that the “drug cocktails” Respondent prescribed of “very potent, high doses” of oxycodone and Xanax (or Valium),
As Dr. Kennedy concluded, Respondent “was not engaged in the practice of medicine,” and “[t]he vast majority of his prescriptions for controlled substances w[as] not for a legitimate medical purpose and w[as] beyond the boundaries of professional practice.”
I therefore also reject Respondent's Exception to the ALJ's ultimate finding that Respondent has committed acts which render his registration inconsistent with the public interest. Resp. Exc. at 5. Because the record establishes that Respondent has repeatedly violated Federal law by issuing controlled substance prescriptions which lacked a legitimate medical purpose and were issued outside of the usual course of professional practice, 21 CFR 1306.04, and Respondent has offered no evidence establishing that he has accepted responsibility for his misconduct and that he has reformed his practice,
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 21 CFR 0.100(b) and 0.104, I order that DEA Certificate of Registration, AD7585865, issued to Jacobo Dreszer, M.D., be, and it hereby is, revoked. I further order that any pending application of Jacobo Dreszer, M.D., to renew or modify his registration, be, and it hereby is, denied. This Order is effective immediately.
John J. Mulrooney, II, Administrative Law Judge. On February 25, 2010, the Deputy Administrator, Drug Enforcement Administration (DEA or Government), issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO), immediately suspending the DEA Certificate of Registration (COR), Number AD7585865, of Jacobo Dreszer, M.D. (Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging
The issue ultimately to be adjudicated by the Deputy Administrator, with the assistance of this recommended decision, is whether the record as a whole establishes by substantial evidence that Respondent's registration with the DEA should be revoked as inconsistent with the public interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4).
After carefully considering the testimony elicited at the hearing, the admitted exhibits, the arguments of counsel, and the record as a whole, I have set forth my recommended findings of fact and conclusions below.
The OSC/ISO issued by the Government alleges that the Respondent, through the medical practice he participated in at American Pain, LLC (American Pain), prescribed and dispensed inordinate amounts of controlled substances, primarily oxycodone,
At the hearing, the Government presented the testimony of three witnesses, DEA Miami Field Division (MFD) Group Supervisor (GS) Susan Langston, DEA Special Agent (SA) Michael Burt, and L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.
GS Langston testified that the investigation of the American Pain Clinic had its origins on November 30, 2009, during a routine inspection that she and a subordinate diversion investigator conducted at Appurtenance Biotechnology, LLC, a pharmacy doing business under the name Boca Drugs (Boca Drugs), and located a few blocks away from one of the former locations of American Pain. Tr. at 713, 717-20. According to Langston, an examination of the prescriptions seized from Boca Drugs revealed that the majority of those prescriptions were for oxycodone and alprazolam authorized over the signature of physicians associated with American Pain.
GS Langston also testified that, on March 3, 2010, a criminal search warrant was executed on the American Pain Clinic simultaneously with the OSC/ISO that initiated the present case. Tr. at 735. According to Langston, the items seized from American Pain included a sign that had been posted in what she believes to have served as the urinalysis waiting room.
Due to increased fraudulent prescriptions, [i]t's best if you fill your medication in Florida or your regular pharmacy. Don't go to a pharmacy in Ohio when you live in Kentucky and had the scripts written in Florida. The police will confiscate your scripts and hold them while they investigate. This will take up to 6 months. So only fill your meds in Florida or a pharmacy that you have been using for at least 3 months or more.
Please do
Langston also testified that while she was present in the American Pain offices, she noticed that each physician's desk was equipped with a group of stamps, each of which depicted a controlled substance medication with a corresponding medication usage instruction (sig). Tr. at 738-39. A photograph of one set of prescription script stamps was admitted as an exhibit.
GS Langston also testified that a great number of medical charts were seized from the American Pain offices, and that she and her staff selected a number of these files to be analyzed by an medical expert procured by the Government. Tr. at 762. According to GS Langston, after the execution of the warrant, the charts from the entire office were placed into piles in alphabetical order, and not separated by physician. Langston testified that she and three of her diversion
Langston also explained DEA's Automated Record Consolidated Ordering System (ARCOS) and testified that she generated an ARCOS report relative to the Respondent's ordering of controlled substances from January 2009 through February 2010. Govt. Ex. 71.
In the same fashion, Langston explained the purposes of and circumstances behind the generation of state prescription monitoring reports (PMPs) relative to the Respondent maintained by West Virginia, Kentucky, and Ohio. Govt. Exs. 72-74. Review of the PMP report data reflects that during the time period of February 1, 2006 through February 11, 2010, pharmacies filled 229 controlled substance prescriptions issued over the Respondent's signature to seventy-three patients located in West Virginia, 135 similar prescriptions provided to fifty-three Kentucky-based patients were filled between January 1, 2009 and April 4, 2010, and 144 such prescriptions pertaining to sixty-three patients located in Ohio were filled between April 1, 2008 and April 19, 2010.
No evidence was introduced at the hearing that would provide any reliable level of context regarding the raw data set forth in the databases received into evidence at the Government's request. Other than the observations noted above, no witness who testified at the hearing ever explained the significance of the data set forth in any of these databases to any issue that must or should be considered in deciding the present case. As discussed above, the fact that the Boca Drugs Prescription Log prepared by the agents does not distinguish between prescriptions authorized by the Respondent and another registrant of the same name deprives the document of virtually any relevance regarding the enforcement action against this Respondent.
GS Langston provided evidence that was sufficiently detailed, consistent and plausible to be deemed credible in this recommended decision.
SA Michael Burt testified that he has been employed by DEA since March 2004 and has been stationed with the Miami Field Division (MFD) since September 2004. Tr. at 813-14. Burt testified that he is the lead case agent for DEA in the investigation of American Pain Clinic and has participated in the investigation since the latter part of 2008. According to Burt, American Pain, which was previously known by the name South Florida Pain, has conducted business at four different locations, and he surveilled the Boca Raton and Lake Worth locations both in person and by periodic live review of video captured via pole cameras
Based on these surveillance efforts, SA Burt testified concerning various activities he observed occurring outside the Boca and Lake Worth clinic locations, which were open to the public from 8 a.m. to 5 p.m. At the Boca location, Burt stated that on any given day, beginning at 7 a.m. in the morning, automobiles could be seen pulling into the parking lot and approximately twenty to thirty people were routinely lined up outside of the clinic waiting to gain admittance. Additionally, there was a steady stream of automobile and foot traffic in and out of the clinic throughout the day.
Based on his review of some (but not all)
SA Burt also testified regarding his review of some
SA Burt also testified that he received information from Dr. Eddie Sollie, a former physician employed during the time period American Pain was doing business as South Florida Pain, who terminated his employment at the Oakland Park clinic location in November or December 2008 after working there for approximately two and a half to three months.
SA Burt also testified regarding the drug overdose deaths of TY and SM after obtaining controlled substances from American Pain.
Perhaps among the more striking aspects of SA Burt's performance on the witness stand is the anticipated testimony which he did not provide. When viewed in its entirety, SA Burt's record testimony was stunningly sparse when compared with his proposed testimony as noticed in the Government's prehearing statement.
Even apart from the marked contrast between the Burt testimony as proffered and as realized, his testimony was marred by periodic memory failures on significant issues and an inability to supply details to an extent that it could arguably have diminished the weight that could be fairly attached to those aspects of his own investigation that he did manage to recollect. During his testimony, SA Burt acknowledged his own marked lack of preparation and unfamiliarity with the investigation and confessed simply that “[t]here's no excuse * * * .”
Even acknowledging its obvious suboptimal aspects, SA Burt's testimony had no apparent nefarious motivation or indicia of intentional deceit. Burt came across as an earnest and believable witness, who, regarding the aspects of the case that he did recall, was able to impart substantial information about the investigation and activities involving American Pain and its doctors. While frequently lacking in detail, his testimony was not internally inconsistent or facially implausible, and although the legal weight I have assigned to certain portions of Burt's testimony varies given the issues described, I find his testimony to be credible overall.
The Government presented the bulk of its case through the report and testimony of its expert, L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.
Dr. Kennedy testified that after a review of a group of selected patient files from those seized at the Respondent's practice that were to him provided by the Government, he concluded that the Respondent's physical examinations, treatment plans, and patient histories were below the standard fixed by the Florida Medical Board and that that controlled substances was not for a legitimate medical purpose.
Dr. Kennedy took professional issue with several aspects of the Respondent's patient care as reflected in the charts regarding the prescribing of controlled substances. It is apparent from his testimony that Dr. Kennedy's analysis is restricted to those matters which can be gleaned from an examination of the written word in that subset of the Respondent's patient charts provided by the Government for his review, and that limitation perforce circumscribes the breadth of his input. That being said, Dr. Kennedy highlighted numerous features in the Respondent's chart documentation that he found wanting, or at least remarkable.
Dr. Kennedy explained that there are basic elements to practicing pain medicine. The acquisition of a thorough history and physical examination is important.
Dr. Kennedy also prepared a report in connection with the Government's case against the Respondent, which is dated April 30, 2010, and was admitted into evidence. Govt. Ex. 76; Tr. at 579. The report describes a general analysis of seventeen charts that the Respondent maintained on as many patients, that were (selected by and) provided to Dr. Kennedy by the Government from among patient files seized pursuant to a criminal search warrant executed at the Respondent's practice on March 3, 2010 (Patient Charts Analysis). Although this report purports to describe practices common to all seventeen files reviewed by Dr. Kennedy, much of the analysis is directed toward a chart prepared in connection with MB,
Dr. Kennedy's report makes it unambiguously clear that, in his opinion, all seventeen of the Respondent's charts that he reviewed suffered from the same shortcomings.
In Dr. Kennedy's opinion, the patient charts he reviewed that were prepared by the Respondent reflected care that fell below the applicable standard on multiple levels. In his report, Dr. Kennedy noted that the treatment notes in the charts: (1) Contained no typewritten clinical notes and were “very brief, difficult to read (often impossible) and not within the standard of care due to their brevity and quality”;
Dr. Kennedy found the Respondent's controlled substance patient monitoring to be deficient in numerous respects. From the reviewed patient charts, Dr. Kennedy gleaned that an initial, in-office urine drug screen was frequently executed during the patients' initial visit to the office but repeated only occasionally. Govt. Ex. 76 at 14. It was Dr. Kennedy's observation that even a drug screen anomaly did not alter the seemingly inexorable continuation of controlled substance prescribing from the Respondent.
The identified shortcomings of controlled substance patient monitoring systems was of particular significance where Dr. Kennedy identified specific evidence that he identified as “red flags” of possible or likely diversion. Red flags noted by Dr. Kennedy in the reviewed charts included the relatively young age of the Respondent's chronic pain patients,
Dr. Kennedy also found it remarkable that each American Pain patient file provided notice to its patients that American Pain did not accept any form of health care insurance. Govt. Ex. 76 at 3, 16. Dr. Kennedy's report set forth his opinion that this practice was designed to “effectively keep [the physicians at American Pain] `off the radar' from monitoring by any private health care insurance company as well as all state and federal agencies (Medicaid and Medicare respectively).
A review of the seventeen patient files that informed the analysis, findings and conclusions offered in Dr. Kennedy's written report and testimony does reflect the presence of at least some of the red flag issues he identified therein, but there was not the unanimity among the files that he repeatedly urges. For instance, in terms of evidence related to therapeutic plans, it is notable that Respondent's patient files contain at least some indications of recommended treatment modalities in addition to the Respondent's exclusive use of
An examination of the reviewed patient charts does reveal the presence of other red flags that should have inspired additional diligence or inquiry on the part of the Respondent. LA's patient file, for example, contains a form indicating a positive UDS for oxycodone and benzodiazepine from 5/18[/09], yet on the same date, the medication contract signed by LA is blank in the section where a patient is supposed to list any medications they are currently taking; likewise, the similarly worded section on the “Patient Comfort Assessment Guide” form also has no medications listed. Govt. Ex. 77 at 12-13, 30;
In addition to the lack of adequately completed forms in some patient files noted by Dr. Kennedy, other patient files appear to be missing key documentation altogether.
Dr. Kennedy concluded his report regarding the Respondent's prescribing practices with the following summary:
[The Respondent] was not engaged in the practice of medicine, rather he was engaged in an efficient, “[a]ssembly [l]ine” business. His “patients” were revenue streams, not true patients. This business allowed him to collect cas[h] for office visits as well as being a “[d]ispensing [p]hysician” for controlled substances. He prescribed controlled substances so that “patients” would return to his office on a regular basis, allowing him to generate further revenue. [The Respondent's] routine and excessive prescription of multiple controlled substances (oxycodone and Xanax) and lack of arriving at a valid medical diagnosis and treatment most likely caused harm to the “patients” he saw. Drug diversion most likely caused a “mushroom” effect of increased drug abuse, drug addiction, drug overdoses, serious bodily injury and death in those communities spread over several different states. [The Respondent's] continued ability to prescribe controlled substances will only perpetuate the suffering and be a threat to the public.
On cross examination, Dr. Kennedy agreed that he assumed, for the purposes of his analysis, that where the Respondent's charts reflected an entry or a procedure, that the event actually occurred. Tr. at 654. Kennedy also acknowledged that every one of the patient files he reviewed contained at least a complaint of chronic pain symptoms by the patient and MRI results that could support such a diagnosis.
The Government's presentation of Dr. Kennedy's testimony at the hearing was substantially consistent with the conclusions included in the Patient Charts Analysis, but Dr. Kennedy's presentation was clearly not without its blemishes. Although he testified that he was familiar with prescribing practices in Florida, and that he utilized the medical standards applicable to Florida practice,
Pursuant to 21 U.S.C. § 824(a)(4), the Deputy Administrator
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“[T]hese factors are considered in the disjunctive.”
In an action to revoke a registrant's DEA COR, the DEA has the burden of proving that the requirements for revocation are satisfied. 21 CFR 1301.44(e). Once DEA has made its
Where the Government has sustained its burden and established that a registrant has committed acts inconsistent with the public interest, that registrant must present sufficient mitigating evidence to assure the Deputy Administrator that he or she can be entrusted with the responsibility commensurate with such a registration.
The Agency's conclusion that past performance is the best predictor of future performance has been sustained on review in the courts,
While the burden of proof at this administrative hearing is a preponderance-of-the-evidence standard,
Regarding the exercise of discretionary authority, the courts have recognized that gross deviations from past agency precedent must be adequately supported,
In this case, it is undisputed that the Respondent holds a valid and current state license to practice medicine. The record contains no evidence of a recommendation regarding the Respondent's medical privileges by any cognizant state licensing board or professional disciplinary authority. However, that a state has not acted against a registrant's medical license is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest.
Similarly, regarding Factor 3, while testimony was received at the hearing that indicated that a criminal search warrant was executed regarding the Respondent and American Pain, the record contains no evidence that the Respondent has ever been convicted of any crime or even arrested in connection with any open criminal investigation. Thus, consideration of the record evidence under the first and third factors does not militate in favor of revocation.
In this case, the gravamen of the allegations in the OSC/ISO, as well as the factual concentration of much of the evidence presented, share as a principal focus the manner in which the Respondent has managed that part of his practice relative to prescribing and dispensing controlled substances and acts allegedly committed in connection with his practice at American Pain. Thus, it is analytically logical to consider public interest factors two, four and five together. That being said, factors two, four and five involve analysis of common and distinct considerations.
Regarding Factor 2, the qualitative manner and the quantitative volume in which a registrant has engaged in the dispensing of controlled substances, and how long he has been in the business of doing so are factors to be evaluated in reaching a determination as to whether he should be entrusted with a DEA certificate. In some cases, viewing a registrant's actions against a backdrop of how he has performed activity within the scope of the certificate can provide a contextual lens to assist in a fair adjudication of whether continued registration is in the public interest.
There are two principal considerations embedded within a consideration of this public interest factor. In considering a similar factor under the List I chemical context, the Agency has recognized that the level of experience held by those who will be charged with recognizing and taking steps to minimize diversion factors greatly in determining whether entrusting a COR will be in the public interest.
In this case, the Respondent introduced no evidence regarding his level of knowledge and experience, or even the quality or length of his experience as a physician-registrant, but the Government has elected to do so.
Regarding the Government's presentation, Agency precedent has long held that in DEA administrative proceedings that “the parameters of the hearing are determined by the prehearing statements.”
In like fashion, the Government's prehearing statement proffered that SA Burt would testify to several of the items described but not established in the OSC/ISO. Among the list of allegations that were
Law enforcement in Florida and [other states that correspond to license plates seen in the American Pain parking lot] frequently arrest people for illegal possession and/or illegal distribution of controlled substances who have obtained the controlled substances from American Pain;
American Pain hired individuals to “roam” the parking lot of the clinic to dissuade people from selling their recently obtained controlled substances on the property;
[The reason American Pain placed] signs within American Pain warning individuals not to have their prescriptions filled at Walgreens pharmacies [is] because Walgreens refuses to dispense the prescriptions;
Walgreens has flagged all American Pain doctors and will not fill any of their prescriptions;
[Physical exams at American Pain are] usually no more than a blood pressure check and some bending and stretching;
Dismissed patients would be routed to other doctors within the clinic;
[There was] co-mingling of [American Pain] physician's drugs;
[American Pain maintained] no inventories of drugs dispensed;
[Details surrounding] the death of [American Pain] patient OB [where] [t]he cause of death was determined to be drug intoxication—opiate and benzodiazepine;
[Information] from a confidential source [who indicated] that she traveled to American Pain in order to obtain controlled substances that were later sold in Kentucky for $25 per pill[,] [that] [the American Pain physician she encountered] did not spend any significant time conducting a physical examination of [her] [,] [that she would simply ask questions regarding [her] well being and would then “stamp” a prescription for [controlled substances][,] * * * that on one visit [during a power failure a] security guard working for the clinic instructed everyone to be patient and that the doctors would be with them shortly to “get your fix.”
To be clear, it is not that the evidence was introduced and discredited; no evidence to support these (and other) allegations was introduced at all. To the extent the Government had this evidence, it left it home. While the stunning disparity between the allegations proffered and those that were supported with any evidence does not raise due process concerns, it is worthy of noting, without deciding the issue, that Agency precedent has acknowledged the Supreme Court's recognition of the applicability of the
The evidence the Government did present raises issues regarding not only Factor 2 (experience dispensing
While true that GS Langston convincingly testified about the course of her investigation and laid an adequate foundation for numerous database results, the Government provided no foundational context for any relevant uses for those database results. Even apart from the unfortunate reality that one of the databases contained data that could not be directly tied to this Respondent as opposed to another with the same last name, without some insight into what types of results from these databases should be expected when compared to similarly-situated registrants engaged in acceptable prescribing practices, the raw data is without use. In short, there was no evidence elicited wherein the percentage of the Respondent's in-state to out-of-state patients could be assessed, and no reasonable measuring stick based on sound principles upon which to evaluate such data. Likewise, there was no reliable yardstick upon which to measure the amount of controlled substances reflected in the databases compared to what a reasonable regulator would expect to see regarding a compliant registrant. To the extent Langston possessed this information (and she well may have) it was not elicited from her. The same could be said of the allegation set forth in the Government's Prehearing Statement that alleges that from a given period the Respondent “was the 8th largest practitioner purchaser of oxycodone in the United States.”
SA Burt testified that, during a temporally limited period of time, he observed some of the images captured by a pole camera positioned outside American Pain, and that he observed what in his view was a high percentage of vehicles in the parking lot with out-of-state license tags. This testimony arguably provides some support for the Government's contention that out-of-state patients (or at least patients being dropped off by cars with out-of-state tags) were being seen at the clinic, but his testimony did not provide much else in terms of relevant information. In any event, recent Agency precedent holds that details such as “where [a registrant's] patients were coming from,” without additional factual development, can support a “strong suspicion that [a] respondent was not engaged in a legitimate medical practice” but that “under the substantial evidence test, the evidence must ‘do more than create a suspicion of the existence of the fact to be established.’ ”
Likewise, without additional details or at least some context, Burt's testimony that individuals with “staff” written on their shirts appeared to be directing patients into the clinic reveals virtually nothing about the Respondent's prescribing practices. Tr. at 818, 910. Furthermore, that Burt observed an individual on a videotape, who he believed to be an American Pain employee, on a single occasion, instruct patients not to “snort [their] pills” in the parking lot,
Burt's testimony regarding his conversations with Dr. Sollie, who was formerly employed by American Pain, was also not received in a manner that could meaningfully assist in the decision process. According to Burt, Sollie told him that some (unnamed) physicians at American Pain were inadequately documenting their patient charts in some manner that was
The Government's evidence targeted not only the Respondent's experience practicing under Factor 2, but also his compliance with applicable state and federal laws relating to controlled substances under Factor 4. To effectuate the dual goals of conquering drug abuse and controlling both legitimate and illegitimate traffic in controlled substances, “Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.”
A registered practitioner is authorized to dispense,
While true that the CSA authorizes the “regulat[ion] of medical practice so far as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood,”
Under the CSA, it is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to act “in the usual course of * * * professional practice” and to issue a prescription for a legitimate medical purpose.”
Under Florida law, grounds for disciplinary action or denial of state licensure include “prescribing * * * any controlled substance, other than in the course of the physician's professional practice,” and prescribing such substances “inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his or her intent.” Fla. Stat. § 458.331(q) (2009). Florida law further provides that grounds for such disciplinary action also include:
Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician * * * and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.
In exercising its rulemaking function,
(2) A licensed physician shall maintain patient medical records in English, in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken.
(3) The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.
(4) All entries made into the medical records shall be accurately dated and timed. Late entries are permitted, but must be clearly and accurately noted as late entries and dated and timed accurately when they are entered in to the record * * *.
With respect to defining the parameters of what constitutes “professional practice” in the context of pain management prescribing, Florida state law provides:
Notwithstanding any other provision of law, a physician may prescribe or administer any controlled substance under Schedules II-V * * * to a person for the treatment of intractable pain,
Like the
The Florida Standards direct that “[p]hysicians should be diligent in preventing the diversion of drugs for illegitimate purposes,”
The Florida Standards further provide that the validity of prescribing will be judged “based on the physician's treatment of the patient and
Although, as discussed above, the Florida Board instituted general guidance applicable to all physicians regarding medical records, it also promulgated a separate set of documentation requirements in the Florida Standards applicable specifically to those physicians who prescribe controlled substances in the pain-management context. The Florida Standards, under the subheading “Medical Records,” state that “[t]he physician is required to keep
1. The medical history and physical examination, including history of drug abuse or dependence, as appropriate;
2. Diagnostic, therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage, and quantity prescribed);
8. Instructions and agreements; and
9. Periodic reviews.
The Florida Standards similarly emphasize the need for proper documentation in the patient evaluation context by specifying:
A complete
Furthermore, the Florida Standards require a written treatment plan that “should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned.”
Another standard adopted by the Florida Board, under the subheading “Informed Consent and Agreement for Treatment,” is the directive that
1. Urine/serum medication levels screening when requested;
2. Number and frequency of all prescription refills; and
3. Reasons for which drug therapy may be discontinued (i.e., violation of agreement).
The Florida Standards contain a further requirement to periodically review “the course of pain treatment and any new information about the etiology of the pain or the patient's state of health.”
Continuation or modification of therapy depends on the physician's evaluation of the patient's progress. If treatment goals are not being achieved, despite medication
Under the subheading “Consultation,” the Florida Board promulgated the instruction that
It is abundantly clear from the plain language of the Florida Standards that the Florida Board places critical emphasis on physician implementation of adequate safeguards in their practice to minimize diversion and the need to document the objective signs and rationale employed in the course of pain treatment utilizing the prescription of controlled substances. Conscientious documentation is repeatedly emphasized as not just a ministerial act, but a key treatment tool and a vital indicator to evaluate whether the physician's prescribing practices are “within the usual course of professional practice.” Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert opinion presented
In his Post-Hearing Brief (Respondent's Brief), the Respondent's counsel has prepared and submitted a thoughtful and detailed review of one of the patient charts that was analyzed by Dr. Kennedy in his report. Respt's Br. at 22-26. While counsel argues that the patient chart entries were, at least by his interpretation of his client's obligations, satisfactory, the expert's opinion at the hearing remained unchanged. Even acknowledging, as this recommended decision does, that Dr. Kennedy's presentation was not without its deficiencies, its shortcomings do not render it so fundamentally defective as to completely undermine his credibility and viability as within the scope of what a litigant may depend upon.
The Respondent, who was in a unique position to conclusively refute Dr. Kennedy's views and explain the format and nuances of the reviewed documentation, elected not to testify in this matter. At a DEA administrative hearing, it is permissible to draw an adverse inference from the silence of the Respondent, even in the face of a Fifth Amendment invocation.
In the Social Security context, where an Administrative Law Judge has received expert medical opinions on the issue of the claimant's ability to work and they are not repudiated in any respect by substantial evidence, an adverse decision should be set aside as based on “suspicion and speculation.”
Accordingly, after carefully balancing the admitted evidence, the evidence establishes, by a preponderance, that the prescriptions the Respondent issued in Florida were not issued within “the usual course of [the Respondent's] professional practice.” 21 CFR 1306.04(a). Consideration of the evidence under the second and fourth factors support the COR revocation sought by the Government in this case.
To the extent that the Respondent's prescribing practices fell below the requisite standard in Florida, that conduct also impacts upon the Fifth statutory factor. Under Factor 5, the Deputy Administrator is authorized to consider “other conduct which may threaten the public health and safety.” 21 U.S.C. 823(f)(5). Although this factor authorizes consideration of a somewhat broader range of conduct reaching beyond those activities typically associated with a registrant's practice, an adverse finding under this factor requires some showing that the relevant conduct actually constituted a threat to public safety.
The evidence establishes that the Respondent engaged in a course of practice wherein he prescribed controlled substances to patients irrespective of the patients' need for such medication and ignoring any and all red flags that could or did indicate likely paths of diversion. The testimony of Dr. Kennedy, the DEA regulations, and the Florida Standards make clear that physicians prescribing controlled substances do so under an obligation to monitor the process to minimize the risk of diversion. The patient charts reflect that the Respondent, contrary to his obligations as a DEA registrant, did not follow up in the face of multiple red flags. The Respondent's disregard of his obligations as a DEA registrant and Federal and state laws related to controlled substances militate in favor of revocation.
By ignoring his responsibilities to monitor the controlled substance prescriptions he was authorizing to minimize diversion, and by participating in an insufficiently documented and thoughtful process for the issuance of potentially dangerous controlled substances, the Respondent created a significant potential conduit for the unchecked diversion of controlled substances.
Agency precedent has consistently held that where, as here, the Government has met its burden to establish a prima facie case that a registrant has committed acts demonstrating that continued registration is inconsistent with the public interest, acceptance of responsibility is a condition precedent to continued registration.
Based on the foregoing, the evidence supports a finding that the Government has established that the Respondent has committed acts that are inconsistent with the public interest. A balancing of the statutory public interest factors supports the revocation of the Respondent's Certificate of Registration and a denial of his application to renew. The Respondent has not accepted responsibility for his actions, expressed remorse for his conduct at any level, or presented evidence that could reasonably support a finding that the Deputy Administrator should continue to entrust him with a Certificate of Registration.
Accordingly, the Respondent's Certificate of Registration should be
On August 10, 2010, Administrative Law Judge (ALJ) John J. Mulrooney, II, issued the attached recommended decision.
Having reviewed the record in its entirety including Respondent's exceptions, I have decided to adopt, except as explained below, the ALJ's
Respondent raises two exceptions to the ALJ's recommended decision. First, he argues that “he was denied the ability to present his positive experience in dispensing controlled substances.” Resp. Exc. at 1. More specifically, he argues that he was denied “access to files seized” by the Government which show that he discharged patients, and that “[w]ithout access to those files,” he was left “with his hands tied behind his back and [was] unable to demonstrate his successful treatment of patients with controlled substances.”
As support for his contention that he is entitled to present evidence of his “positive experience,” Respondent cites the Agency's decision on remand in
While this Agency complied with the Eleventh Circuit's order, unpublished decisions are “not precedential.”
I thus assumed—even though there was no evidence (except for twelve patient files) in the record regarding the legitimacy of the practitioner's prescribing of controlled substances to the “thousands of other patients” she had treated—that her prescribings to these patients constituted “positive experience.”
As
DEA has thus revoked a practitioner's registration based on a single act of presenting two fraudulent prescriptions to a pharmacy for filling;
Consistent with these precedents, I held in
In any event, as discussed above, Respondent offered no evidence on the issue of his experience in dispensing controlled substances and the ALJ's ultimate conclusion that Respondent violated the CSA's prescription requirement because he dispensed controlled substance prescriptions that were not “within” ‘usual course of [his] professional practice,'' ALJ at 41 (quoting 21 CFR 1306.04(a)), and that “the evidence under the [experience] * * * factor[] support[s]” the revocation of his registration, is consistent with Agency precedent.
With respect to factor five, “[s]uch other conduct which may threaten public health and safety,” 21 U.S.C. 823(f)(5), the ALJ opined that “an adverse finding under this factor requires some showing that the relevant conduct
The ALJ also opined that “[i]t is clear that in assessing whether the controlled substance prescribing practices of a Florida practitioner fall within the acceptable range of what constitutes being within the bounds of being ‘issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice,’ resort must be had to an expert.” ALJ at 37 (quoting 21 CFR 1306.04(a)). While the ALJ properly noted the importance of expert testimony in this case, in which the Government primarily relied on a review of the medical charts, whether expert testimony is needed is necessarily dependent on the nature of the allegations and the other evidence in the case. Where, for example, the Government produces evidence of undercover visits showing that a physician knowingly engaged in outright drug deals, expert testimony adds little to the proof necessary to establish a violation of Federal law.
Respondent's exception is neither factually nor legally well taken. Contrary to his assertion that his hands were “tie[d] behind his back” and that he was “effectively cripple[ed]” from “present[ing] any evidence of” what he terms “his positive * * * experience,”
Most significantly, Respondent could have testified regarding his prescribing practices with respect to the patients whose files were reviewed by the Government's Expert and which formed the basis for the latter's (and the ALJ's) conclusion that Respondent acted outside of the usual course of professional practice and lacked a legitimate medical purpose in prescribing controlled substances to them.
Respondent also takes exception to the ALJ's finding that he was not prejudiced by the Government's failure to turn over “the discharged patient files,” as well as evidence pertaining to a second undercover officer to whom he refused to prescribe. Resp. Exc. at 2. Respondent asserts that his right to Due Process was violated because this evidence “could have exonerated” him, “or at the very least, given him an opportunity to meaningfully defend against the Government's allegations,” and that prejudice “must [be] assume[d] * * * because neither he nor the Court were ever given access to it.”
As an initial matter, while there is evidence that Respondent refused to prescribe to a second undercover officer, there is no evidence establishing that there were, in fact, “discharged patient files.” Respondent neither testified, nor offered any other evidence such as an affidavit establishing, that such files exist. Most significantly, in his Exceptions, Respondent does not cite any authority for the proposition that the Agency is required to provide broad discovery in a proceeding under sections 303 and 304 of the CSA.
In
It is well settled, however, that neither the Due Process Clause, nor the Administrative Procedure Act (nor DEA's rules of procedure) require the Agency to provide a general right of discovery in administrative proceedings.
In this case, the ALJ based his conclusion that Respondent issued numerous prescriptions outside of the usual course of professional practice in violation of both Federal and State laws and thus had committed acts which render his registration inconsistent with the public interest,
There is likewise no merit to Respondent's contention that he was prejudiced by the Government's failure to turn over the patient file of the undercover officer to whom he refused to prescribe. A Special Agent testified that Respondent had refused to prescribe to a second undercover officer and the Government failed to put forward any evidence regarding the circumstances of this visit (such as what the officer said to Respondent). For this reason alone, it was proper for the ALJ to draw an inference adverse to the Government and conclude that Respondent properly complied with the rules of the Florida Board of Medicine in evaluating the undercover officer.
As noted above, Respondent did not testify. Nor did he offer the testimony of an expert. Thus, Respondent did not refute the opinion testimony of the Government's Expert that he repeatedly violated the prescription requirement of Federal law. Because Respondent failed “to testify in response to [the] probative evidence offered against” him, I conclude (as did the ALJ) that it is appropriate to draw an adverse inference against him and hold that he knowingly issued prescriptions in violation of 21 CFR 1306.04(a).
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 21 CFR 0.100(b) and 0.104, I order that DEA Certificate of Registration, FB0254918, issued to Beau Boshers, M.D., be, and it hereby is revoked. I further order that any pending application of Beau Boshers, M.D., to renew or modify his registration, be, and it hereby is, denied.
This Order is effective immediately.
John J. Mulrooney, II, Administrative Law Judge. On February 25, 2010, the Deputy Administrator, Drug Enforcement Administration (DEA or Government), issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO), immediately suspending the DEA Certificate of Registration (COR), Number FB02549187, of Beau Boshers, M.D. (Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging that such registration constitutes an imminent danger to the public health and safety. The OSC/ISO also sought revocation of the Respondent's registration, pursuant to 21 U.S.C. 824(a)(4), and denial of any pending applications for renewal
The issue ultimately to be adjudicated by the Deputy Administrator, with the assistance of this recommended decision, is whether the record as a whole establishes by substantial evidence that Respondent's registration with the DEA should be revoked as inconsistent with the public interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4).
After carefully considering the testimony elicited at the hearing, the admitted exhibits, the arguments of counsel, and the record as a whole, I have set forth my recommended findings of fact and conclusions below.
The OSC/ISO issued by the Government alleges that the Respondent, through the medical practice he participated in at American Pain, LLC (American Pain), prescribed and dispensed inordinate amounts of controlled substances, primarily oxycodone,
At the hearing, the Government presented the testimony of three witnesses, DEA Miami Field Division (MFD) Group Supervisor (GS) Susan Langston, DEA Special Agent (SA) Michael Burt, and L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.
GS Langston testified that the investigation of the American Pain Clinic had its origins on November 30, 2009, during a routine inspection that she and a subordinate diversion investigator conducted at Appurtenance Biotechnology, LLC, a pharmacy doing business under the name Boca Drugs (Boca Drugs), and located a few blocks away from one of the former locations of American Pain. Tr. at 713, 717-20. According to Langston, an examination of the prescriptions seized from Boca Drugs revealed that the majority of those prescriptions were for oxycodone and alprazolam authorized over the signature of physicians associated with American Pain.
GS Langston also testified that, on March 3, 2010, a criminal search warrant was executed on the American Pain Clinic simultaneously with the OSC/ISO that initiated the present case. Tr. at 735. According to Langston, the items seized from American Pain included a sign that had been posted in what she believes to have served as the urinalysis waiting room.
Due to increased fraudulent prescriptions, [i]t's best if you fill your medication in Florida or your regular pharmacy. Don't go to a pharmacy in Ohio when you live in Kentucky and had the scripts written in Florida. The police will confiscate your scripts and hold them while they investigate. This will take up to 6 months. So only fill your meds in Florida or a pharmacy that you have been using for at least 3 months or more.
Please do
Langston also testified that while she was present in the American Pain offices, she noticed that each physician's desk was equipped with a group of stamps, each of which depicted a controlled substance medication with a corresponding medication usage instruction (sig). Tr. at 738-39. A photograph of one set of prescription script stamps was admitted as an exhibit.
GS Langston also testified that a great number of medical charts were seized from the American Pain offices, and that she and her staff selected a number of these files to be analyzed by an medical expert procured by the Government. Tr. at 762. According to GS Langston, after the execution of the warrant, the charts from the entire office were placed into piles in alphabetical order, and not separated by physician. Langston testified that she and three of her diversion investigators reviewed the seized files with a view towards choosing approximately fifteen files for each doctor with the aspirational criteria that each would reflect at least three to four visits by that doctor with a patient. Each investigator was empowered to place a chart on the selected pile, and when the target number (or about that number) was reached for each physician, the selection effort relative to that physician was deemed accomplished.
Langston also explained DEA's Automated Record Consolidated Ordering System (ARCOS)
In the same fashion, Langston explained the purposes of and circumstances behind the generation of state prescription monitoring reports (PMPs) relative to the Respondent maintained by West Virginia, Kentucky and Ohio. Govt. Exs. 24-26. Review of the PMP report data reflects that during the time period of February 1, 2006 through February 11, 2010, pharmacies filled 259 controlled substance prescriptions issued over the Respondent's signature to sixty-eight patients located in West Virginia, 173 similar prescriptions provided to seventy-nine Kentucky-based patients were filled between January 1, 2009 and April 4, 2010, and ninety such prescriptions pertaining to sixty-one patients located in Ohio were filled between April 1, 2008 and April 19, 2010.
No evidence was introduced at the hearing that would provide any reliable level of context regarding the raw data
GS Langston provided evidence that was sufficiently detailed, consistent and plausible to be deemed credible in this recommended decision.
SA Michael Burt testified that he has been employed by DEA since March 2004 and has been stationed with the Miami Field Division (MFD) since September 2004. Tr. at 813-14. Burt testified that he is the lead case agent for DEA in the investigation of American Pain Clinic and has participated in the investigation since the latter part of 2008. According to Burt, American Pain, which was previously known by the name South Florida Pain, has conducted business at four different locations, and he surveilled the Boca Raton and Lake Worth locations both in person and by periodic live review of video captured via pole cameras
Based on these surveillance efforts, SA Burt testified concerning various activities he observed occurring outside the Boca and Lake Worth clinic locations, which were open to the public from 8 a.m. to 5 p.m. At the Boca location, Burt stated that on any given day, beginning at 7 a.m. in the morning, automobiles could be seen pulling into the parking lot and approximately twenty to thirty people were routinely lined up outside of the clinic waiting to gain admittance. Additionally, there was a steady stream of automobile and foot traffic in and out of the clinic throughout the day.
Based on his review of some (but not all)
SA Burt also testified regarding his review of some
Although noticed in SA Burt's proposed testimony identified in the Government's prehearing statement, testimony regarding the specifics of the UC's visits to see the Respondent at American Pain was not elicited by the Government during its direct examination, but was brought out on cross-examination to meet the Government's admitted evidence consisting of a patient file kept by the Respondent relative to the UC and the accompanying expert report and testimony concerning that file provided by Dr. Kennedy.
More troubling by far is the revelation during SA Burt's cross examination that in addition to UC Luis Lopez, a second UC went into American Pain during July 2009 and recorded his encounters with the Respondent. Those encounters by the second UC did not culminate with the Respondent prescribing controlled substances.
SA Burt also testified that he received information from Dr. Eddie Sollie, a former physician employed during the time period American Pain was doing business as South Florida Pain, who terminated his employment at the Oakland Park clinic location in November or December 2008 after working there for approximately two and a half to three months.
SA Burt also provided testimony concerning three confidential sources (only one of whom was seen by the Respondent) and their contacts with doctors at American Pain. Relative to the Respondent, the first confidential source (CS1) discussed by Burt was arrested in Washington, DC after transporting upwards of 3,000 oxycodone pills from south Florida to Massachusetts, and at the time of his arrest, Burt testified that an empty prescription pill bottle from American Pain with the Respondent's name on it was found on his person.
SA Burt also testified regarding the drug overdose deaths of TY and SM after obtaining controlled substances from American Pain.
Perhaps among the more striking aspects of SA Burt's performance on the witness stand is the anticipated testimony which he did not provide. When viewed in its entirety, SA Burt's record testimony was stunningly sparse when compared with his proposed
Even apart from the marked contrast between the Burt testimony as proffered and as realized, his testimony was marred by periodic memory failures on significant issues and an inability to supply details to an extent that it could arguably have diminished the weight that could be fairly attached to those aspects of his own investigation that he did manage to recollect. During his testimony, SA Burt acknowledged his own marked lack of preparation and unfamiliarity with the investigation and confessed simply that “[t]here's no excuse * * *.”
Even acknowledging its obvious suboptimal aspects, SA Burt's testimony had no apparent nefarious motivation or indicia of intentional deceit. Burt came across as an earnest and believable witness, who, regarding the aspects of the case that he did recall, was able to impart substantial information about the investigation and activities involving American Pain and its doctors. While frequently lacking in detail, his testimony was not internally inconsistent or facially implausible, and although the legal weight I have assigned to certain portions of Burt's testimony varies given the issues described, I find his testimony to be credible overall.
The Government presented the bulk of its case through the report and testimony of its expert, L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.
During the course of his testimony, Dr. Kennedy explained that he took professional issue with several aspects of the Respondent's patient care as reflected in the charts regarding the prescribing of controlled substances. It is apparent from his testimony that Dr. Kennedy's analysis is restricted to those matters which can be gleaned from an examination of the written word in that subset of the Respondent's patient files provided by the Government for his review, and that limitation perforce circumscribes the breadth of his testimony. That being said, Dr. Kennedy highlighted numerous features in the Respondent's chart documentation that he found wanting, or at least remarkable.
While, during his testimony, Dr. Kennedy acknowledged that some level of standardization and utilization of forms is not, standing alone, improper,
Dr. Kennedy explained that there are basic elements to practicing pain medicine. The acquisition of a thorough history and physical examination is important.
Kennedy also explained the importance of establishing a differential or working diagnosis on the first visit, and modifying and reviewing that diagnosis as more information and results become available.
Dr. Kennedy testified that in his expert opinion, the Respondent's histories and physical examinations were “grossly deficient in that [the documentation] didn't really justify why the [patient] was given the high doses of narcotics or controlled substance that they were.”
Although Dr. Kennedy had earlier conceded that it is the judgment of the examining physician that is generally relied upon in determining the necessity and appropriateness of diagnostic testing,
Dr. Kennedy prepared two reports in connection with the Government's case against the Respondent, both of which are dated April 30, 2010, and both of which were admitted into evidence during his testimony. Govt. Exs. 28, 131; Tr. at 174, 194. One of the reports describes a general analysis of seventeen charts that the Respondent maintained on as many patients, that were (selected by and) provided to Dr. Kennedy by the Government from among patient files seized pursuant to a criminal search warrant executed at the Respondent's practice on March 3, 2010 (Patient Charts Analysis).
Many of the observations and conclusions contained within the two reports are remarkably similar. Dr. Kennedy's report makes it unambiguously clear that, at least in his opinion, all eighteen of the Respondent's charts that he reviewed suffered from the same shortcomings. The Patient Charts Analysis states that the Respondent's patient charts that Dr. Kennedy reviewed “are essentially the same with regard to review issues; as stated in the report of [RZ] referenced and discussed in this report in detail, [and that] there were no significant differences that affected [his] conclusions and summary.” Govt. Ex. 28 at 2. A like-worded proviso accompanies Dr. Kennedy's analysis of the chart prepared in connection with the undercover officer's (Luis Lopez's) interaction in the Supplemental Chart Analysis. Govt. Ex. 131 at 1.
In Dr. Kennedy's opinion, the patient charts he reviewed that were prepared by the Respondent reflected care that fell below the applicable standard on multiple levels. In his report, Dr. Kennedy noted that the treatment notes in the charts: (1) contained no typewritten clinical notes and were “very brief, difficult to read (often impossible) and not within the standard of care due to their brevity and quality”;
Dr. Kennedy found the Respondent's controlled substance patient monitoring to be deficient in numerous respects. From the reviewed patient charts, Dr. Kennedy gleaned that an initial, in-office urine drug screen was frequently executed during the patients' initial visit to the office but repeated only occasionally.
The identified shortcomings of controlled substance patient monitoring systems was of particular significance where Dr. Kennedy identified specific evidence that he identified as “red flags” of possible or likely diversion. In addition to providing incomplete information on his patient questionnaires, the undercover officer (a/k/a Luis Lopez) admitted to the Respondent that he had previously purchased oxycodone on the street. Govt. Exs. 46 at 9, 131 at 3. Other red flags noted by Dr. Kennedy in the reviewed charts included the relatively young age (in Kennedy's view) of the Respondent's chronic pain patients,
At the hearing, Dr. Kennedy testified that the entries in some of the charts that reflected that the patients were acquiring controlled substances “off the street,” and urine drug screen results that were inconsistent with patient disclosures, were red flags that should have motivated a prudent physician to perform additional due-diligence steps, that, in addition to discussing the matter with the patient, could include reaching out to family members, previous treating physicians and pharmacists, obtaining past medical records, and additional testing. Tr. at 359-60, 362. Dr. Kennedy testified that his evaluation revealed that these red flags were present in the charts and precipitated no due-diligence actions on the Respondent's part.
On the issue of red flags, WA's patient file contains the Respondent's handwritten notation indicating the patient acquired oxycodone and Xanax “off [the] streets,” yet the Respondent authorized prescriptions for Roxicodone, Xanax, and Percocet to WA during his initial and subsequent visits. Govt. Ex. 29 at 11, 23-33. Like scenarios were also apparent in the charts of numerous other patients who had informed the Respondent that they had previously acquired such substances in this illegal manner, including the undercover law enforcement officer (Luis Lopez).
KA's patient file contains a form indicating a positive UDS for opiates and oxycodone from 7/9/09, yet on the same date, the patient comfort assessment guide and medication contract signed by KA are both blank in the section where a patient is supposed to list any medications he or she is currently taking. Govt. Ex. 30 at 14-15, 33;
Dr. Kennedy also found it remarkable that each American Pain patient file provided notice to its patients that American Pain did not accept any form of health care insurance. Govt. Ex. 28 at 3-4, 16. Dr. Kennedy's report set forth his opinion that this practice was designed to “effectively keep [the physicians at American Pain] `off the radar' from monitoring by any private health care insurance company as well as all state and federal agencies (Medicaid and Medicare respectively). Govt. Ex. 28 at 16. Significantly, however, when asked, Dr. Kennedy acknowledged that he conducts his own current medical practice on a cash-only basis. Tr. at 151.
Notwithstanding the discomfiture that Dr. Kennedy expressed regarding non-physician referrals in his report, during his testimony at the hearing he clarified that it was not unusual for a physician to treat patients that have been referred by relatives and friends.
A review of the 18 patient files that informed the analysis, findings and
Dr. Kennedy concluded his report regarding the Respondent's prescribing practices with the following summary:
[The Respondent] was not engaged in the practice of medicine, rather he was engaged in an efficient, “[a]ssembly [l]ine” business. His “patients” were revenue streams, not true patients. This business allowed him to collect cas[h] for office visits as well as being a “[d]ispensing [p]hysician” for controlled substances. He prescribed controlled substances so that “patients” would return to his office on a regular basis, allowing him to generate further revenue. [The Respondent's] routine and excessive prescription of multiple controlled substances (oxycodone and Xanax) and lack of arriving at a valid medical diagnosis and treatment most likely caused harm to the “patients” he saw. Drug diversion most likely caused a “mushroom” effect of increased drug abuse, drug addiction, drug overdoses, serious bodily injury and death in those communities spread over several different states. [The Respondent's] continued ability to prescribe controlled substances will only perpetuate the suffering and be a threat to the public.
Govt. Ex. 28 at 16.
On cross examination at the hearing, Dr. Kennedy's attention was directed to what would seem, at least to a lay person, to present as including a significant level of detail set forth in the charts he reviewed relative to the Respondent's patient documentation, including both subjective complaints of discomfort and objective signs of medical anomalies. Tr. at 214-27, 230, 233-38, 243-44, 246-56, 262-66, 269-70, 273-87, 289-98, 305-08, 311-18, 320-29, 332-47, 366. Even the file prepared in connection with the undercover officer's interaction with the Respondent reflects recorded subjective complaints coupled with a remarkable MRI and other objective signs indicating some medical pathology.
The Government's presentation of Dr. Kennedy's testimony at the hearing was substantially consistent with the conclusions included in the Patient Charts Analysis, but Dr. Kennedy's presentation was clearly not without its blemishes. Although he testified that he was familiar with prescribing practices in Florida, and that he utilized the medical standards applicable to Florida practice,
Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“[T]hese factors are considered in the disjunctive.”
In an action to revoke a registrant's DEA COR, the DEA has the burden of proving that the requirements for revocation are satisfied. 21 CFR 1301.44(e). Once DEA has made its
Where the Government has sustained its burden and established that a registrant has committed acts inconsistent with the public interest, that registrant must present sufficient mitigating evidence to assure the Deputy Administrator that he can be entrusted with the responsibility commensurate with such a registration.
The Agency's conclusion that past performance is the best predictor of future performance has been sustained on review in the courts,
While the burden of proof at this administrative hearing is a preponderance-of-the-evidence standard,
Regarding the exercise of discretionary authority, the courts have recognized that gross deviations from past agency precedent must be adequately supported,
In this case, it is undisputed that the Respondent holds a valid and current state license to practice medicine. The record contains no evidence of a recommendation regarding the Respondent's medical privileges by any cognizant state licensing board or professional disciplinary authority. However, that a state has not acted against a registrant's medical license is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest.
Similarly, regarding Factor 3, while testimony was received at the hearing that indicated that a criminal search warrant was executed regarding the Respondent and American Pain, the record contains no evidence that the Respondent has ever been convicted of any crime or even arrested in connection with any open criminal investigation. Thus, consideration of the record evidence under the first and third factors does not militate in favor of revocation.
In this case, the gravamen of the allegations in the OSC, as well as the factual concentration of much of the evidence presented, share as a principal focus the manner in which the Respondent has managed that part of his practice relative to prescribing and dispensing controlled substances and acts allegedly committed in connection with his practice at American Pain. Thus, it is analytically logical to consider public interest factors two, four and five together. That being said, factors two, four and five involve analysis of both common and distinct considerations.
Regarding Factor 2, the qualitative manner and the quantitative volume in which a registrant has engaged in the dispensing of controlled substances, and how long he has been in the business of doing so are factors to be evaluated in reaching a determination as to whether he should be entrusted with a DEA certificate. In some cases, viewing a registrant's actions against a backdrop of how he has performed activity within the scope of the certificate can provide a contextual lens to assist in a fair adjudication of whether continued registration is in the public interest.
There are two principal considerations embedded within a consideration of this public interest factor. In considering a similar factor under the List I chemical context, the Agency has recognized that the level of experience held by those who will be charged with recognizing and taking steps to minimize diversion factors greatly in determining whether entrusting a COR will be in the public interest.
In this case, notwithstanding the Respondent's
Regarding the Government's presentation, Agency precedent has long held that in DEA administrative proceedings that “the parameters of the hearing are determined by the prehearing statements.”
In like fashion, the Government's prehearing statement proffered that SA Burt would testify to several of the items described but not established in the OSC/ISO. Among the list of allegations that were
Law enforcement in Florida and [other states that correspond to license plates seen in the American Pain parking lot] frequently arrest people for illegal possession and/or illegal distribution of controlled substances who have obtained the controlled substances from American Pain;
American Pain hired individuals to “roam” the parking lot of the clinic to dissuade people from selling their recently obtained controlled substances on the property;
[The reason American Pain placed] [t]here are signs within American Pain warning individuals not to have their prescriptions filed at Walgreens pharmacies [is] because Walgreens refuses to dispense the prescriptions;
Walgreens has flagged all American Pain doctors and will not fill any of their prescriptions;
[Physical exams at American Pain are] usually no more than a blood pressure check and some bending and stretching;
Dismissed patients would be routed to other doctors within the clinic;
[There was] co-mingling of [American Pain] physician's drugs;
[American Pain maintained] no inventories of drugs dispensed;
[Details surrounding] the death of [American Pain] patient OB [where] [t]he cause of death was determined to be drug intoxication—opiate and benzodiazepine;
[Information] from a confidential source [who indicated] that she traveled to American Pain in order to obtain controlled substances that were later sold in Kentucky for $25 per pill[,] [that] [the American Pain physician she encountered] did not spend any significant time conducting a physical examination of [her] [,] [that she would simply ask questions regarding [her] well being and would then “stamp” a prescription for [controlled substances][,] * * * that on one visit [during a power failure a] security guard working for the clinic instructed everyone to be patient and that the doctors would be with them shortly to “get your fix.”
To be clear, it is not that the evidence was introduced and discredited; no evidence to support these (and other) allegations was introduced at all. To the extent the Government had this evidence, it left it home. While the stunning disparity between the allegations proffered and those that were supported with any evidence does not raise due process concerns, it is worthy of noting, without deciding the issue, that Agency precedent has acknowledged the Supreme Court's recognition of the applicability of the
The evidence the Government did present raises issues regarding not only Factor 2 (experience dispensing
While true that GS Langston convincingly testified about the course of her investigation and laid an adequate foundation for numerous database results, the Government provided no foundational context for any relevant uses for those database results. Without some insight into what types of results from these databases should be expected when compared to similarly-situated registrants engaged in acceptable prescribing practices, the raw data is without use. In short, there was no evidence elicited wherein the percentage of the Respondent's in-state to out-of state patients could be assessed, and no reasonable measuring stick based on sound principles upon which to evaluate such data. Likewise, there was no reliable yardstick upon which to measure the amount of controlled substances reflected in the databases compared to what a reasonable regulator would expect to see regarding a compliant registrant. To the extent Langston possessed this information (and she well may have) it was not elicited from her. The same could be said of the allegation set forth in the Government's Prehearing Statement that alleges that from a given period the Respondent “was the 5th largest practitioner purchaser of oxycodone in the United States.”
SA Burt testified that, during a temporally limited period of time, he observed some of the images captured by a pole camera positioned outside American Pain, and that he observed what in his view was a high percentage of vehicles in the parking lot with out-of-state license tags. This testimony arguably provides some support for the Government's contention that out-of-state patients (or at least patients being dropped off by cars with out-of-state tags) were being seen at the clinic, but his testimony did not provide much else in terms of relevant information. In any event, recent Agency precedent holds that details such as “where [a registrant's] patients were coming from,” without additional factual development, can support a “strong suspicion that [a] respondent was not engaged in a legitimate medical practice” but that “under the substantial evidence test, the evidence must `do more than create a suspicion of the existence of the fact to be established.' ”
Likewise, without additional details or at least some context, Burt's testimony that individuals with “staff” written on their shirts appeared to be directing patients into the clinic reveals virtually nothing about the Respondent's prescribing practices. Tr. 818, 910. Furthermore, that Burt observed an individual on a videotape, who he believed to be an American Pain employee, on a single occasion, instruct patients not to “snort [their] pills” in the parking lot,
Burt's testimony regarding his conversations with Dr. Sollie, who was formerly employed by American Pain, was also not received in a manner that could meaningfully assist in the
The Government evidence connected with Burt's testimony concerning the undercover operations focused on the Respondent unfolded in a somewhat disquieting manner when viewed in context with the prior motion practice in this case. As a preliminary matter, it must be acknowledged that Burt's testimony regarding the details of the Luis Lopez evolution, because it lacked detail, was of negligible import. Burt related that the UC told him that American Pain employees made statements and Burt viewed some statements on videotape, but there is no indication as to who the employees were, why Burt or the UC believed them to be employees, or what the basis for the directions to the patients were. For example, American Pain employees advising patients to avoid a particular pharmacy would doubtless have more relevance to these proceedings if the Government had presented any evidence that the pharmacy to be avoided (Walgreens) had some aversion to filling American Pain prescriptions. There was no such evidence. To the extent the Government was seeking to introduce the UC interaction evidence with a view toward reflecting on the Respondent's prescribing practices, evidence regarding the details of the interaction between the Respondent and the UC would seem to have been imperative.
Of somewhat more concern is the procedural context of the UC-related portions of the Government's case. During pre-hearing procedures, the Respondent sought discovery in the form of,
“Respondent in this matter will be provided the documents and testimony to be used against him, and will be permitted to confront and cross examine witnesses and evidence presented by the Government at hearing.”
“While discovery beyond the regulations is not a viable option available to the parties in this action, the position taken by the Government, if taken to its natural analytical conclusion, would allow it to intentionally seize exculpatory evidence, render it unavailable, and prevail in an administrative enforcement action that requires a due process hearing [with a footnote that added that] [t]here is no indication that such a scenario has taken place or would take place here. [The Order went on to state that] [w]hile the analytical simplicity of the Government's position is facially appealing, it is unlikely that Congress, in enacting the APA and the Controlled Substances Act, intended such a result.”
In
Furthermore, in this case, because SA Burt's testimony regarding the UC's interaction with the Respondent has been afforded no weight, the non-availability of the details regarding the unsuccessful UC has resulted in no adverse impact regarding the Respondent's case. This is ever so much more true where an adverse inference has resulted in the assumption that the only such credited interaction in the record was in all ways appropriate. Put another way, the Government's attempt to show that the Respondent's interaction with the successful UC demonstrated his proclivity to dole out controlled substances for insufficient reasons was not persuasive.
The Government's evidence at the hearing targeted not only the Respondent's experience practicing under Factor 2, but also his compliance with applicable state and federal laws relating to controlled substances under Factor 4. To effectuate the dual goals of conquering drug abuse and controlling both legitimate and illegitimate traffic in controlled substances, “Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.”
A registered practitioner is authorized to dispense,
While true that the CSA authorizes the “regulat[ion] of medical practice so far as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood,”
Under the CSA, it is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to act “in the usual course of * * * professional practice” and to issue a prescription for a legitimate medical purpose.”
Under Florida law, grounds for disciplinary action or denial of state licensure include “prescribing * * * any controlled substance, other than in the course of the physician's professional practice,” and prescribing such substances “inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his or her intent.” Fla. Stat. § 458.331(q) (2009). Florida law further provides that grounds for such disciplinary action also include:
Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician * * * and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.
In exercising its rulemaking function,
(2) A licensed physician shall maintain patient medical records in English, in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken.
(3) The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.
(4) All entries made into the medical records shall be accurately dated and timed. Late entries are permitted, but must be clearly and accurately noted as late entries and dated and timed accurately when they are entered in to the record * * *.
With respect to defining the parameters of what constitutes “professional practice” in the context of pain management prescribing, Florida state law provides:
Notwithstanding any other provision of law, a physician may prescribe or administer any controlled substance under Schedules II-V * * * to a person for the treatment of intractable pain,
Like the
The Florida Standards direct that “[p]hysicians should be diligent in preventing the diversion of drugs for illegitimate purposes,”
The Florida Standards further provide that the validity of prescribing will be judged “based on the physician's treatment of the patient and
Although, as discussed above, the Florida Board instituted general guidance applicable to all physicians regarding medical records, it also
1. The medical history and physical examination, including history of drug abuse or dependence, as appropriate;
2. Diagnostic, therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage, and quantity prescribed);
8. Instructions and agreements; and
9. Periodic reviews.
The Florida Standards similarly emphasize the need for proper documentation in the patient evaluation context by specifying:
A complete
Furthermore, the Florida Standards require a written treatment plan that “should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned.”
Another standard adopted by the Florida Board, under the subheading “Informed Consent and Agreement for Treatment,” is the directive that
1. Urine/serum medication levels screening when requested;
2. Number and frequency of all prescription refills; and
3. Reasons for which drug therapy may be discontinued (
The Florida Standards contain a further requirement to periodically review “the course of pain treatment and any new information about the etiology of the pain or the patient's state of health.”
Continuation or modification of therapy depends on the physician's evaluation of the patient's progress. If treatment goals are not being achieved, despite medication
Under the subheading “Consultation,” the Florida Board promulgated the instruction that
It is abundantly clear from the plain language of the Florida Standards that the Florida Board places critical emphasis on physician implementation of adequate safeguards in their practice to minimize diversion and the need to document the objective signs and rationale employed in the course of pain treatment utilizing the prescription of controlled substances. Conscientious documentation is repeatedly emphasized as not just a ministerial act, but a key treatment tool and a vital indicator to evaluate whether the physician's prescribing practices are “within the usual course of professional practice.” Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert witness to testify at these proceedings, reflects that the documentation he reviewed in the Respondent's patient charts reflected care that was markedly below the standard of care set by the Florida Medical Board. Dr. Kennedy's expert assessment was consistent with the state statutory and regulatory guidance. In Kennedy's view, the Respondent's charts demonstrated minimalistic, incomplete, and otherwise medically inadequate documentation of his contacts with patients, and the prescribing rationale for his issuance of controlled substance prescriptions to those patients for alleged pain management purposes. The boilerplate-style, “one high-dosage controlled substances treatment plan fits all” nature of nearly all of the patient medical records at issue, at least in the view of the uncontroverted expert, evidences a failure on the part of the Respondent to conduct his practice of medicine in a manner to minimize the potential of controlled substance abuse and diversion, and supports a conclusion that he failed to even substantially comply with the minimum obligations for professional practice imposed under the Florida Standards—and without “good cause [] shown for such deviation.”
The Respondent, who was in a unique position to conclusively refute Dr. Kennedy's views and explain the format and nuances of the reviewed documentation, elected not to testify in this matter. At a DEA administrative hearing, it is permissible to draw an adverse inference from the silence of the Respondent, even in the face of a Fifth Amendment invocation.
In the Social Security context, where an Administrative Law Judge has received expert medical opinions on the issue of the claimant's ability to work and they are not repudiated in any respect by substantial evidence, an adverse decision should be set aside as based on “suspicion and speculation.”
Accordingly, after carefully balancing the admitted evidence, even applying an adverse inference that permits the assumption that the Respondent was approached by an undercover agent and acted appropriately, the evidence establishes, by a preponderance, that the prescriptions the Respondent issued in Florida were not issued within “the usual course of [the Respondent's] professional practice.” 21 CFR 1306.04(a). Consideration of the evidence under the second and fourth factors support the COR revocation sought by the Government in this case.
To the extent that the Respondent's prescribing practices fell below the requisite standard in Florida, that conduct also impacts upon the Fifth statutory factor. Under Factor 5, the Deputy Administrator is authorized to consider “other conduct which may threaten the public health and safety.” 21 U.S.C. 823(f)(5). Although this factor authorizes consideration of a somewhat broader range of conduct reaching beyond those activities typically associated with a registrant's practice, an adverse finding under this factor requires some showing that the relevant conduct actually constituted a threat to public safety.
The evidence establishes that the Respondent engaged in a course of practice wherein he prescribed controlled substances to patients irrespective of the patients' need for such medication and ignoring any and all red flags that could or did indicate likely paths of diversion. The testimony of Dr. Kennedy, the DEA regulations, and the Florida Standards make clear that physicians prescribing controlled substances do so under an obligation to monitor the process to minimize the risk of diversion. The patient charts reflect that the Respondent, contrary to his obligations as a DEA registrant, did not follow up in the face of multiple red flags. The Respondent's disregard of his obligations as a DEA registrant and Federal and State laws related to controlled substances militate in favor of revocation.
By ignoring his responsibilities to monitor the controlled substance prescriptions he was authorizing to minimize diversion, and by participating in an insufficiently documented and thoughtful process for the issuance of potentially dangerous controlled substances, the Respondent created a significant potential conduit for the unchecked diversion of controlled substances.
Agency precedent has consistently held that where, as here, the Government has met its burden to establish a prima facie case that a registrant has committed acts demonstrating that continued registration is inconsistent with the public interest, acceptance of responsibility is a condition precedent to continued registration.
Based on the foregoing, the evidence supports a finding that the Government has established that the Respondent has committed acts that are inconsistent with the public interest. A balancing of the statutory public interest factors supports the revocation of the Respondent's Certificate of Registration and a denial of his application to renew. The Respondent has not accepted responsibility for his actions, expressed remorse for his conduct at any level, or presented evidence that could reasonably support a finding that the Deputy Administrator should continue to entrust him with a Certificate of Registration. Accordingly, the Respondent's Certificate of Registration should be
Dated: August 10, 2010.
On August 10, 2010, Administrative Law Judge (ALJ) John J. Mulrooney, II, issued the attached recommended decision.
Having reviewed the record in its entirety including the ALJ's recommended decision, I have decided to adopt the ALJ's rulings, findings of fact,
In any event, Respondent offered no evidence on the issue of his experience in dispensing controlled substances and the ALJ's ultimate conclusions that Respondent violated the CSA's prescription requirement because he dispensed controlled substance prescriptions that were not “within ‘the usual course of [his] professional practice,’ ” ALJ at 39 (quoting 21 CFR 1306.04(a)), and that “the evidence under the [experience] * * * factor[] support[s]” the revocation of his registration, is consistent with Agency precedent.
With respect to factor five, “[s]uch other conduct which may threaten public health and safety,” 21 U.S.C. 823(f)(5), the ALJ opined that “an adverse finding under this factor requires some showing that the relevant conduct
The ALJ also opined that “[i]t is clear that in assessing whether the controlled substance prescribing practices of a Florida practitioner fall within the acceptable range of what constitutes being within the bounds of being ‘issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice,’ resort must be had to an expert.” ALJ at 34 (quoting 21 CFR 1306.04(a)). While the ALJ properly noted the importance of expert testimony in this case, in which the Government primarily relied on a review of the medical charts, whether expert testimony is needed in any case necessarily depends on the nature of the allegations and the other evidence in the case. Where, for example, the Government produces evidence of undercover visits showing that a physician knowingly engaged in outright drug deals, expert testimony adds little to the proof necessary to establish a violation of Federal law.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 21 CFR 0.100(b) and 0.104, I order that DEA Certificate of Registration, BA6733578, issued to Michael J. Aruta, M.D., be, and it hereby is revoked. I further order that any pending application of Michael J. Aruta, M.D., to renew or modify his registration, be, and it hereby is, denied.This Order is effective immediately.
John J. Mulrooney, II, Administrative Law Judge. On February 25, 2010, the Deputy Administrator, Drug Enforcement Administration (DEA or Government), issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO), immediately suspending the DEA Certificate of Registration (COR), Number BA6733578, of Michael J. Aruta, M.D. (Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging that such registration constitutes an imminent danger to the public health and safety. The OSC/ISO also seeks revocation of the Respondent's registration, pursuant to 21 U.S.C. 824(a)(4), and denial of any pending applications for renewal or modification of such registration, pursuant to 21 U.S.C. 823(f), alleging that the Respondent's continued registration is inconsistent with the public interest, as that term is used in 21 U.S.C. 823(f). On March 24, 2010, the Respondent timely requested a hearing, which was conducted in Miami, Florida, on July 7, 2010 through July 9, 2010.
The issue ultimately to be adjudicated by the Deputy Administrator, with the assistance of this recommended decision, is whether the record as a whole establishes by substantial evidence that Respondent's registration with the DEA should be revoked as inconsistent with the public interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4). The Respondent's DEA practitioner registration expires by its terms on June 30, 2012.
After carefully considering the testimony elicited at the hearing, the admitted exhibits, the arguments of counsel, and the record as a whole, I have set forth my recommended findings of fact and conclusions below.
The OSC/ISO issued by the Government alleges that the Respondent, through the medical practice he had been conducting at American Pain, LLC (American Pain), has prescribed and dispensed inordinate amounts of controlled substances, primarily oxycodone,
At the hearing, the Government presented the testimony of three witnesses, DEA Miami Field Division (MFD) Group Supervisor (GS) Susan Langston, DEA Special Agent (SA) Michael Burt, and L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.
GS Langston testified that the investigation of the American Pain Clinic had its origins on November 30, 2009, during a routine inspection that she and a subordinate diversion investigator conducted at Appurtenance Biotechnology, LLC, a pharmacy doing business under the name Boca Drugs (Boca Drugs), and located a few blocks away from one of the former locations of American Pain. Tr. at 713, 717-20. According to Langston, an examination of the prescriptions seized from Boca Drugs revealed that the majority of those prescriptions were for oxycodone and alprazolam authorized over the signature of physicians associated with American Pain.
GS Langston also testified that, on March 3, 2010, a criminal search warrant was executed on the American Pain Clinic simultaneously with the OSC/ISO that initiated the present case. Tr. at 735. According to Langston, the items seized from American Pain included a sign that had been posted in what she believes to have served as the urinalysis waiting room. Tr. at 735-37. The seized sign set forth the following guidance:
Due to increased fraudulent prescriptions, [i]t's best if you fill your medication in Florida or your regular pharmacy. Don't go to a pharmacy in Ohio when you live in Kentucky and had the scripts written in Florida. The police will confiscate your scripts and hold them while they investigate. This will take up to 6 months. So only fill your meds in Florida or a pharmacy that you have been using for atleast 3 months or more.
Langston also testified that while she was present in the American Pain offices, she noticed that each physician's desk was equipped with a group of stamps, each of which depicted a controlled substance medication with a corresponding medication usage instruction (sig). Tr. at 738-39. A photograph of one set of prescription script stamps was admitted as an exhibit.
GS Langston also testified that a great number of medical charts were seized from the American Pain offices, and that she and her staff selected a number of these files to be analyzed by a medical expert procured by the Government. Tr. at 762. According to GS Langston, after the execution of the warrant, the charts from the entire office were placed into piles in alphabetical order, and not separated by physician. Langston testified that she and three of her diversion investigators reviewed the seized files with a view towards choosing approximately fifteen files for each doctor with the aspirational criteria that each would reflect at least three to four visits by that doctor with a patient. Each investigator was empowered to place a chart on the selected pile, and when the target number (or about that number) was reached for each physician, the selection effort relative to that physician was deemed accomplished.
Langston also explained DEA's Automated Record Consolidated Ordering System (ARCOS)
In the same fashion, Langston explained the purposes of and circumstances behind the generation of State prescription monitoring reports (PMPs) relative to the Respondent maintained by West Virginia and Kentucky. Govt. Exs. 3, 4. Review of the PMP report data reflects that during the time period of February 1, 2006 through February 11, 2010, pharmacies filled 210 controlled substance prescriptions issued over the Respondent's signature to fifty-five patients located in West Virginia, and 182 similar prescriptions provided to seventy-eight Kentucky-based patients were filled between January 1, 2009 and April 4, 2010.
No evidence was introduced at the hearing that would provide any reliable level of context regarding the raw data set forth in the databases received into evidence at the Government's request. Other than the observations noted above, no witness who testified at the hearing ever explained the significance
GS Langston provided evidence that was sufficiently detailed, consistent and plausible to be deemed credible in this recommended decision.
SA Michael Burt testified that he has been employed by DEA since March 2004 and has been stationed with the Miami Field Division (MFD) since September 2004. Tr. at 813-14. Burt testified that he is the lead case agent for DEA in the investigation of American Pain Clinic and has participated in the investigation since the latter part of 2008. According to Burt, American Pain, which was previously known by the name South Florida Pain, has conducted business at four different locations, and he surveilled the Boca Raton and Lake Worth locations both in person and by periodic live review of video captured via pole cameras
Based on these surveillance efforts, SA Burt testified concerning various activities he observed occurring outside the Boca and Lake Worth clinic locations, which were open to the public from 8 a.m. to 5 p.m. At the Boca location, Burt stated that on any given day, beginning at 7 a.m. in the morning, automobiles could be seen pulling into the parking lot and approximately twenty to thirty people were routinely lined up outside of the clinic waiting to gain admittance. Additionally, there was a steady stream of automobile and foot traffic in and out of the clinic throughout the day.
Based on his review of some (but not all)
SA Burt also testified regarding his review of some
SA Burt also testified that he received information from Dr. Eddie Sollie, a former physician employed during the time period American Pain was doing business as South Florida Pain, who terminated his employment at the Oakland Park clinic location in November or December 2008 after working there for approximately two and a half to three months.
SA Burt also provided testimony concerning three confidential sources (only one of whom was seen by the Respondent) and their contacts with doctors at American Pain. Relative to the Respondent, Burt testified concerning his April 2009 debriefing of a confidential source of information (CS2) based in Kentucky who came to Burt's attention through his Kentucky law enforcement contacts.
SA Burt also testified regarding the drug overdose deaths of TY and SM after obtaining controlled substances from American Pain.
Perhaps among the more striking aspects of SA Burt's performance on the witness stand is the anticipated testimony which he did not provide. When viewed in its entirety, SA Burt's record testimony was stunningly sparse when compared with his proposed testimony as noticed in the Government's prehearing statement.
Even apart from the marked contrast between the Burt testimony as proffered and as realized, his testimony was marred by periodic memory failures on significant issues and an inability to supply details to an extent that it could arguably have diminished the weight that could be fairly attached to those aspects of his own investigation that he did manage to recollect. During his testimony, SA Burt acknowledged his own marked lack of preparation and unfamiliarity with the investigation and confessed simply that “[t]here's no excuse *** ”
Even acknowledging its obvious suboptimal aspects, SA Burt's testimony had no apparent nefarious motivation or indicia of intentional deceit. Burt came across as an earnest and believable witness, who, regarding the aspects of the case that he did recall, was able to impart substantial information about the investigation and activities involving American Pain and its doctors. While frequently lacking in detail, his testimony was not internally inconsistent or facially implausible, and although the legal weight I have assigned to certain portions of Burt's testimony varies given the issues described, I find his testimony to be credible overall.
The Government presented the bulk of its case through the report and testimony of its expert, L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.
Dr. Kennedy prepared a report in connection with the Government's case against the Respondent, which is dated April 30, 2010, and was admitted into evidence during his testimony. Govt. Ex. 5. The report describes a general analysis of fifteen charts that the Respondent maintained on as many patients, that were (selected by and) provided to Dr. Kennedy by the Government
In Dr. Kennedy's expert opinion, based on a documentary review of the patient charts from the Respondent's practice that he reviewed, the Respondent's prescribing practices fell below the standards set forth by the Florida Medical Board. Tr. at 118. Furthermore, Dr. Kennedy testified that after reviewing the charts, he was unable to identify any legitimate basis for prescribing any of the controlled substance medications prescribed to the patients named in the charts.
During the course of his testimony, Dr. Kennedy explained that he took professional issue with several aspects of the Respondent's patient care as reflected in the charts regarding the prescribing of controlled substances. It is apparent from his testimony that Dr. Kennedy's analysis is restricted to those matters which can be gleaned from an examination of the written word in that subset of the Respondent's patient charts provided by the Government for his review, and that limitation perforce circumscribes the breadth of his testimony. That being said, Dr. Kennedy highlighted numerous features in the Respondent's chart documentation that he found wanting, or at least remarkable.
While acknowledging that some standardization and utilization of forms is not, standing alone, improper,
Dr. Kennedy explained that there are basic elements to practicing pain medicine. The acquisition of a thorough history and physical examination is important.
Kennedy also explained the importance of establishing a differential or working diagnosis on the first visit and modifying and reviewing that diagnosis as more information and results become available.
Dr. Kennedy testified that, in his expert opinion, the medical histories taken by the Respondent in the reviewed files were insufficiently detailed to meet the standards set by the Florida Board of Medicine to justify the prescribing of controlled substances.
Similarly, Dr. Kennedy opined that Respondent's treatment plans, as they were reflected in the reviewed records, were “grossly inadequate” in that the use of controlled substances was the single option considered and employed, “[s]o everybody got essentially the same treatment regardless of their complaint, severity, physical examination [and] history.”
Dr. Kennedy also made the ironic observation that although to the “extremely rare”
Although Dr. Kennedy conceded that it is the judgment of the examining physician that is generally relied upon in determining the necessity and appropriateness of diagnostic testing,
Dr. Kennedy opined that the Respondent's prescribing of opioids lacked a legitimate medical purpose in that he routinely prescribed oxycodone in initial 30 milligram (mg) doses that significantly exceeded the recommended 0.5 to 2.5 mg starting dosage.
In this regard, Dr. Kennedy highlighted the chart of patient JR.
If the records that the patient filled out themselves [sic] are correct, then that especially given with the Xanax, which is a benzodiazepine like Valium[,] [i]ts generic name is alprazolam[,] [a]nd that's a high dose of Xanax as well. [] [T]he typical starting dose of Xanax is .25 to 0.5 [mg]. So, that's four to eight times higher than the usual dose on that, and that's given twice daily. Given that they work different areas in the nervous system and they both can cause sedation and potentially respiratory depression, there's at least an additive if not a synergistic effect between when you mix different components of an opioid like oxycodone, a narcotic pain reliever, with a benzodiazepine like Xanax, alprazolam, especially at those doses in a naïve person for both drugs, that makes it even more dangerous.
No sir, this isn't even close. There's no room, wiggle room on this. This is absolutely beyond the pale.
Notwithstanding his expressed concerns over the potency of some of the controlled substances prescribed by the Respondent, Dr. Kennedy was struck by the fact the charts of several of the Respondent's patients reflected no indication that any acceptable measure of mental status, cognitive ability and response time was undertaken.
On cross-examination, Dr. Kennedy agreed that the reviewed charts reflected objective signs that arguably supported medically determinable impairments that could cause chronic pain conditions, and that the controlled substance medications that were prescribed by the Respondent were among those that could be correctly employed to treat chronic pain.
In his Patient Charts Analysis, Dr. Kennedy focuses on a patient chart related to GA, one of the Respondent's patients, and opines that the flaws identified in GA's chart are common to all fifteen of the Respondent's files that he reviewed. Specifically, the Patient Charts Analysis states that the charts he reviewed “are essentially the same with regard to review issues; as stated in the report of [GA] referenced and discussed in this report in detail, [and that] there were no significant differences that affected [his] conclusions and summary.” Govt. Ex. 5 at 2.
In Dr. Kennedy's opinion, the patient charts he reviewed that were prepared by the Respondent reflected care that fell below the applicable standard on multiple levels. In his report, Dr. Kennedy noted that the treatment notes in the charts: (1) Contained no typewritten clinical notes and were “very brief, difficult to read (often impossible) and not within the bounds of professional practice due to their brevity and quality”;
Dr. Kennedy found the Respondent's controlled substance patient monitoring to be deficient in numerous respects. From the reviewed patient charts, Dr. Kennedy gleaned that an initial, in-office urine drug screen was frequently executed during the patients' initial visit to the office but repeated only occasionally. Govt. Ex. 5 at 14. It was Dr. Kennedy's observation that even a drug screen anomaly did not alter the seemingly inexorable continuation of controlled substance prescribing from the Respondent.
The identified shortcomings of controlled substance patient monitoring systems was of particular significance where Dr. Kennedy identified specific evidence that he identified as “red flags” of possible or likely diversion. Red flags noted by Dr. Kennedy in the reviewed charts included the relatively young age of the Respondent's chronic pain patients,
Although Dr. Kennedy's report and testimony appear to attach some significance to referrals that originated in family and friends, he later clarified that it was not unusual for a physician to treat patients that have been referred by relatives and friends.
During his testimony as well as his report, Dr. Kennedy highlighted several features of particular charts that, at least in his view, bore the indicia of some red flags that should have signaled an increased risk of controlled substance diversion. Kennedy detailed several controls that should have been, but were apparently not utilized by the Respondent to monitor diversion risks in a pain management practice.
Although not touched upon by Dr. Kennedy in his testimony or report,
Interestingly, in his report, Dr. Kennedy also found it remarkable that each American Pain patient file provided notice to its patients that American Pain did not accept any form of health care insurance. Govt. Ex. 5 at 3, 16. The report reflected Kennedy's view that this practice was designed to “effectively keep [the physicians at American Pain] `off the radar' from monitoring by any private health care insurance company as well as all State and Federal agencies (Medicaid and Medicare respectively).”
Dr. Kennedy concluded his report regarding the Respondent's prescribing practices with the following summary:
[The Respondent] was not engaged in the practice of medicine, rather he was engaged in an efficient, “[a]ssembly [l]ine” business. His “patients” were revenue streams, not true patients. This business allowed him to collect cas[h] for office visits as well as being a “[d]ispensing [p]hysician” for controlled substances. He prescribed controlled substances so that “patients” would return to his office on a regular basis, allowing him to generate further revenue. [The Respondent's] routine and excessive prescription of multiple controlled substances (oxycodone and Xanax) and lack of arriving at a valid medical diagnosis and treatment most likely caused harm to the “patients” he saw. Drug diversion most likely caused a “mushroom” effect of increased drug abuse, drug addiction, drug overdoses, serious bodily injury and death in those communities spread over several different states. [The Respondent's] continued ability to prescribe controlled substances will only perpetuate the suffering and be a threat to the public.
The Government's presentation of Dr. Kennedy's testimony at the hearing was substantially consistent with the conclusions included in the Patient Charts Analysis, but Dr. Kennedy's presentation was clearly not without its blemishes. Although he testified that he was familiar with prescribing practices in Florida, and that he utilized the medical standards applicable to Florida practice,
Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“[T]hese factors are considered in the disjunctive.”
In an action to revoke a registrant's DEA COR, the DEA has the burden of proving that the requirements for revocation are satisfied. 21 CFR 1301.44(e). Once DEA has made its
Where the Government has sustained its burden and established that a registrant has committed acts inconsistent with the public interest, that registrant must present sufficient mitigating evidence to assure the Deputy Administrator that he or she can be entrusted with the responsibility commensurate with such a registration.
The Agency's conclusion that past performance is the best predictor of future performance has been sustained on review in the courts,
While the burden of proof at this administrative hearing is a preponderance-of-the-evidence standard,
Regarding the exercise of discretionary authority, the courts have recognized that gross deviations from past agency precedent must be adequately supported,
In this case, it is undisputed that the Respondent holds a valid and current State license to practice medicine. The record contains no evidence of a recommendation regarding the Respondent's medical privileges by any cognizant State licensing board or professional disciplinary authority. However, that a State has not acted against a registrant's medical license is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest.
Similarly, regarding Factor 3, while testimony was received at the hearing
In this case, the gravamen of the allegations in the OSC, as well as the factual concentration of much of the evidence presented, share as a principal focus the manner in which the Respondent has managed that part of his practice relative to prescribing and dispensing controlled substances and acts allegedly committed in connection with his practice at American Pain. Thus, it is analytically logical to consider public interest factors two, four and five together. That being said, factors two, four and five involve analysis of both common and distinct considerations.
Regarding Factor 2, the qualitative manner and the quantitative volume in which a registrant has engaged in the dispensing of controlled substances, and how long he has been in the business of doing so are factors to be evaluated in reaching a determination as to whether he should be entrusted with a DEA certificate. In some cases, viewing a registrant's actions against a backdrop of how he has performed activity within the scope of the certificate can provide a contextual lens to assist in a fair adjudication of whether continued registration is in the public interest.
There are two principal considerations embedded within a consideration of this public interest factor. In considering a similar factor under the List I chemical context, the Agency has recognized that the level of experience held by those who will be charged with recognizing and taking steps to minimize diversion factors greatly in determining whether entrusting a COR will be in the public interest.
In this case, the Respondent introduced no evidence regarding his level of knowledge and experience, or even the quality or length of his experience as a physician-registrant, but the Government has elected to do so.
Regarding the Government's presentation, Agency precedent has long held that in DEA administrative proceedings “the parameters of the hearing are determined by the prehearing statements.”
In like fashion, the Government's prehearing statement proffered that SA Burt would testify to several of the items described but not established in the OSC/ISO. Among the list of allegations that were
Law enforcement in Florida and [other states that correspond to license plates seen in the American Pain parking lot] frequently arrest people for illegal possession and/or illegal distribution of controlled substances who have obtained the controlled substances from American Pain;
American Pain hired individuals to “roam” the parking lot of the clinic to dissuade people from selling their recently obtained controlled substances on the property;
[The reason American Pain placed] signs within American Pain warning individuals not to have their prescriptions filled at Walgreens pharmacies [is] because Walgreens refuses to dispense the prescriptions;
Walgreens has flagged all American Pain doctors and will not fill any of their prescriptions;
[Physical exams at American Pain are] usually no more than a blood pressure check and some bending and stretching;
Dismissed patients would be routed to other doctors within the clinic;
[There was] co-mingling of [American Pain] physician's drugs;
[American Pain maintained] no inventories of drugs dispensed;
[Details surrounding] the death of [American Pain] patient OB [where] [t]he cause of death was determined to be drug intoxication—opiate and benzodiazepine;
[Information] from a confidential source [who indicated] that she traveled to American Pain in order to obtain controlled substances that were later sold in Kentucky for $25 per pill[,] [that] [the American Pain physician she encountered] did not spend any significant time conducting a physical examination of [her] [,] [that she would simply ask questions regarding [her] well being and would then “stamp” a prescription for [controlled substances][,] * * * that on one visit [during a power failure a] security guard working for the clinic instructed everyone to be patient and that the doctors would be with them shortly to “get your fix.”
The Government's Prehearing Statement also represented that it would
To be clear, it is not that the evidence was introduced and discredited; no evidence to support these (and other) allegations was introduced at all. To the extent the Government had this evidence, it left it home. While the stunning disparity between the allegations proffered and those that were supported with any evidence does not raise due process concerns, it is worthy of noting, without deciding the issue, that Agency precedent has acknowledged the Supreme Court's recognition of the applicability of the
The evidence the Government did present raises issues regarding not only Factor 2 (experience dispensing
While true that GS Langston convincingly testified about the course of her investigation and laid an adequate foundation for numerous database results, the Government provided no foundational context for any relevant uses for those database results. Without some insight into what types of results from these databases should be expected when compared to similarly-situated registrants engaged in acceptable prescribing practices, the raw data is without use. In short, there was no evidence elicited wherein the percentage of the Respondent's in-State to out-of State patients could be assessed, and no reasonable measuring stick based on sound principles upon which to evaluate such data. Likewise, there was no reliable yardstick upon which to measure the amount of controlled substances reflected in the databases compared to what a reasonable regulator would expect to see regarding a compliant registrant. To the extent Langston possessed this information (and she well may have) it was not elicited from her. The same could be said of the allegation set forth in the Government's Prehearing Statement that alleges that from a given period the Respondent “was the 16th largest practitioner purchaser of oxycodone in the United States.”
SA Burt testified that, during a temporally limited period of time, he observed some of the images captured by a pole camera positioned outside American Pain, and that he observed what in his view was a high percentage of vehicles in the parking lot with out-of-State license tags. This testimony arguably provides some support for the Government's contention that out-of-State patients (or at least patients being dropped off by cars with out-of-State tags) were being seen at the clinic, but his testimony did not provide much else in terms of relevant information. In any event, recent Agency precedent holds that details such as “where [a registrant's] patients were coming from,” without additional factual development, can support a “strong suspicion that [a] respondent was not engaged in a legitimate medical practice” but that “under the substantial evidence test, the evidence must `do more than create a suspicion of the existence of the fact to be established.'”
Likewise, without additional details or at least some context, Burt's testimony that individuals with “staff” written on their shirts appeared to be directing patients into the clinic reveals virtually nothing about the Respondent's prescribing practices. Tr. 818, 910. Furthermore, that Burt observed an individual on a videotape, who he believed to be an American Pain employee, on a single occasion, instruct patients not to “snort [their] pills” in the parking lot,
Burt's testimony regarding his conversations with Dr. Sollie, who was formerly employed by American Pain, were also not received in a manner that could meaningfully assist in the decision process. According to Burt, Sollie told him that some (unnamed) physicians at American Pain were inadequately documenting their patient charts in some manner that was apparently never explained to Burt,
The Government's evidence targeted not only the Respondent's experience practicing under Factor 2, but also his compliance with applicable State and Federal laws relating to controlled substances under Factor 4. To effectuate the dual goals of conquering drug abuse and controlling both legitimate and
A registered practitioner is authorized to dispense,
While true that the CSA authorizes the “regulat[ion] of medical practice so far as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood,”
Under the CSA, it is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to act “in the usual course of * * * professional practice” and to issue a prescription for a legitimate medical purpose.”
Under Florida law, grounds for disciplinary action or denial of State licensure include “prescribing * * * any controlled substance, other than in the course of the physician's professional practice,” and prescribing such substances “inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his or her intent.” Fla. Stat. § 458.331(q) (2009). Florida law further provides that grounds for such disciplinary action also include:
Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician * * * and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.
In exercising its rulemaking function,
(2) A licensed physician shall maintain patient medical records in English, in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken.
(3) The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.
(4) All entries made into the medical records shall be accurately dated and timed. Late entries are permitted, but must be clearly and accurately noted as late entries and dated and timed accurately when they are entered in to the record * * * .
With respect to defining the parameters of what constitutes “professional practice” in the context of pain management prescribing, Florida State law provides:
Notwithstanding any other provision of law, a physician may prescribe or administer any controlled substance under Schedules II-V * * * to a person for the treatment of intractable pain,
Like the
The Florida Standards direct that “[p]hysicians should be diligent in preventing the diversion of drugs for illegitimate purposes,”
The Florida Standards further provide that the validity of prescribing will be judged “based on the physician's treatment of the patient and
Although, as discussed above, the Florida Board instituted general guidance applicable to all physicians regarding medical records, it also promulgated a separate set of documentation requirements in the Florida Standards applicable specifically to those physicians who prescribe controlled substances in the pain-management context. The Florida Standards, under the subheading “Medical Records,” state that “[t]he physician is required to keep
1. The medical history and physical examination, including history of drug abuse or dependence, as appropriate;
2. Diagnostic, therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage, and quantity prescribed);
8. Instructions and agreements; and
9. Periodic reviews.
The Florida Standards similarly emphasize the need for proper documentation in the patient evaluation context by specifying:
A complete
Furthermore, the Florida Standards require a written treatment plan that “should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned.”
Another standard adopted by the Florida Board, under the subheading “Informed Consent and Agreement for Treatment,” is the directive that
1. Urine/serum medication levels screening when requested;
2. Number and frequency of all prescription refills; and
3. Reasons for which drug therapy may be discontinued (
The Florida Standards contain a further requirement to periodically review “the course of pain treatment and any new information about the etiology of the pain or the patient's state of health.”
Continuation or modification of therapy depends on the physician's evaluation of the patient's progress. If treatment goals are not being achieved, despite medication
Under the subheading “Consultation,” the Florida Board promulgated the instruction that
It is abundantly clear from the plain language of the Florida Standards that the Florida Board places critical emphasis on physician implementation of adequate safeguards in their practice to minimize diversion and the need to document the objective signs and rationale employed in the course of pain treatment utilizing the prescription of controlled substances. Conscientious documentation is repeatedly emphasized as not just a ministerial act, but a key treatment tool and a vital indicator to evaluate whether the physician's prescribing practices are “within the usual course of professional practice.” Here, the uncontroverted expert opinion of Dr. Kennedy, the only expert witness to testify at these proceedings, reflects that the documentation he reviewed in the Respondent's patient charts reflected care that was markedly below the standard of care set by the Florida Medical Board. Dr. Kennedy's expert assessment was consistent with the State statutory and regulatory guidance. In Kennedy's view, the Respondent's charts demonstrated minimalistic, incomplete, and otherwise medically inadequate documentation of his contacts with patients and the prescribing rationale for his issuance of controlled substance prescriptions to those patients for alleged pain management purposes. The boilerplate-style, “one high-dosage controlled substances treatment plan fits all” nature of nearly all of the patient medical records at issue, at least in the view of the uncontroverted expert, evidences a failure on the part of the Respondent to conduct his practice of medicine in a manner to minimize the potential of controlled substance abuse and diversion, and supports a conclusion that he failed to even substantially comply with the minimum obligations for professional practice imposed under the Florida Standards—and without “good cause [] shown for such deviation.”
In his Argument, Proposed Findings of Fact and Proposed Conclusions of Law (Respondent's Brief), the Respondent's counsel has prepared and submitted a thoughtful and detailed analysis of the counsel's application of the relevant standards in Florida to the charts analyzed by Dr. Kennedy. Respt's Br. at 3-17. Unfortunately, counsel's analysis is the product of a lay evaluation of standards applicable to the nuanced and sophisticated science that is the practice of medicine. Where his opinion and that of the only accepted medical expert to provide an expert opinion conflict, his opinion cannot and will not be afforded controlling deference. Argument supplied by counsel (albeit a diligent and persuasive counsel) that the relevant standards were satisfactorily applied as evidenced by the protocols and procedures documented in the patient charts cannot supplant the unrefuted view of an accepted expert witness.
The Respondent, who was in a unique position to conclusively refute Dr. Kennedy's views and explain the format and nuances of the reviewed documentation, elected not to testify in this matter. At a DEA administrative hearing, it is permissible to draw an adverse inference from the silence of the Respondent, even in the face of a Fifth Amendment invocation.
In the Social Security context, where an Administrative Law Judge has received expert medical opinions on the issue of the claimant's ability to work and they are not repudiated in any respect by substantial evidence, an adverse decision should be set aside as based on “suspicion and speculation.”
Accordingly, after carefully balancing the admitted evidence, the evidence establishes, by a preponderance of the evidence, that the prescriptions the Respondent issued in Florida were not issued within “the usual course of [the Respondent's] professional practice.” 21 CFR 1306.04(a). Consideration of the evidence under the second and fourth factors support the COR revocation sought by the Government in this case.
To the extent that the Respondent's prescribing practices fell below the requisite standard in Florida, that conduct also impacts upon the Fifth statutory factor. Under Factor 5, the Deputy Administrator is authorized to consider “other conduct which may threaten the public health and safety.” 21 U.S.C. 823(f)(5). Although this factor authorizes consideration of a somewhat broader range of conduct reaching beyond those activities typically associated with a registrant's practice, an adverse finding under this factor requires some showing that the relevant conduct actually constituted a threat to public safety.
The evidence establishes that the Respondent engaged in a course of practice wherein he prescribed unsafely high doses of controlled substances to patients irrespective of the patients' need for such medication and ignoring any and red flags that could or did indicate likely paths of diversion. The testimony of Dr. Kennedy, the DEA regulations, and the Florida Standards make clear that physicians prescribing controlled substances do so under an obligation to monitor the process to minimize the risk of diversion. The patient charts reflect that the Respondent, contrary to his obligations as a DEA registrant, did not follow up in the face of multiple red flags. The Respondent's disregard of his obligations as a DEA registrant and Federal and State laws related to controlled substances militate in favor of revocation.
By routinely prescribing unsafely high doses of controlled substances to opioid-naïve patients and ignoring his responsibilities to monitor the controlled substance prescriptions he was authorizing to minimize diversion, and by participating in an insufficiently documented and thoughtful process for the issuance of potentially dangerous controlled substances, the Respondent created a significant potential conduit for the unchecked diversion of controlled substances.
Agency precedent has consistently held that where, as here, the Government has met its burden to establish a prima facie case that a registrant has committed acts demonstrating that continued registration is inconsistent with the public interest, acceptance of responsibility is a condition precedent to continued registration.
Based on the foregoing, the evidence supports a finding that the Government has established that the Respondent has committed acts that are inconsistent with the public interest. A balancing of the statutory public interest factors supports the revocation of the Respondent's Certificate of Registration and a denial of his application to renew. The Respondent has not accepted responsibility for his actions, expressed remorse for his conduct at any level, or presented evidence that could reasonably support a finding that the Deputy Administrator should continue to entrust him with a Certificate of Registration.
Accordingly, the Respondent's Certificate of Registration should be
Dated: August 10, 2010.
On August 10, 2010, Administrative Law Judge (ALJ) John J. Mulrooney, II, issued the attached recommended decision.
Having reviewed the entire record including the ALJ's recommended decision and Respondent's exceptions, I have decided to adopt the ALJ's rulings, findings of fact,
In any event, Respondent offered no evidence on the issue of his experience in dispensing controlled substances and the ALJ's ultimate conclusions that Respondent violated the CSA's prescription requirement because he dispensed controlled substance prescriptions that were not “within `the usual course of [his] professional practice,'” ALJ at 39 (quoting 21 CFR 1306.04(a)), and that “the evidence under the [experience] * * * factor[] support[s]” the revocation of his registration, is consistent with Agency precedent.
With respect to factor five, “[s]uch other conduct which may threaten public health and safety,” 21 U.S.C. 823(f)(5), the ALJ opined that “an adverse finding under this factor requires some showing that the relevant conduct
The ALJ also opined that “[i]t is clear that in assessing whether the controlled substance prescribing practices of a Florida practitioner fall within the acceptable range of what constitutes being within the bounds of being `issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice,' resort must be had to an expert.” ALJ at 34 (quoting 21 CFR 1306.04(a)). While the ALJ properly noted the importance of expert testimony in this case, in which the Government primarily relied on a review of the medical charts, whether expert testimony is needed in any case necessarily depends on the nature of the allegations and the other evidence in the case. Where, for example, the Government produces evidence of undercover visits showing that a physician knowingly engaged in outright drug deals, expert testimony adds little to the proof necessary to establish a violation of Federal law.
Respondent first takes exception to the ALJ's acceptance of L. Douglas Kennedy, M.D., as an expert on the proper prescribing of controlled substances. Respondent contends that Dr. Kennedy should not have been permitted to opine on his prescribing practices because he does not hold a DEA registration in Florida, has not prescribed a controlled substance since 2004, does not currently have either a medical office or hospital privileges in Florida, and “has never practiced medicine regularly in Florida and has not practiced medicine in Florida at all in over 10 years.” Resp. Exc. at 1.
Respondent's contention is unavailing as Dr. Kennedy was clearly qualified to render an expert opinion on the proper practice for prescribing controlled substances to treat pain and whether Respondent's controlled substance prescriptions were issued in the usual course of professional practice and for a legitimate medical purpose.
Dr. Kennedy has published several articles and book chapters on pain management issues and has made several dozen presentations on pain management issues at professional meetings.
Thus, Dr. Kennedy was clearly qualified to provide expert testimony. I therefore agree with the ALJ that Dr. Kennedy's testimony was sufficiently reliable to constitute substantial evidence on the issue of whether Respondent acted within the usual course of professional practice and had a legitimate medical purpose in prescribing controlled substances to the patients whose files he reviewed and reject this exception. ALJ at 17.
Next, Respondent contends that Dr. Kennedy's opinion testimony is entitled to no weight because it was based on only sixteen patient charts, which Respondent maintains were not randomly selected and is too small a sample to draw sufficient conclusions about the validity of his prescribing practices. Resp. Exc. at 2. In support of this contention, Respondent relies on Dr. Kennedy's testimony that “ `[i]t might not be fair' ” to “ `cherry-pick[]' ” sixteen charts out of a physician's patients because those might be the “the only people out of 2,000” and that the problems found would “be `an administrative issue for education with the Board of Medical License and not' ” necessarily justify the revocation of Respondent's medical license (or DEA registration).
However, even acknowledging that one of the sixteen files reviewed by Dr. Kennedy with respect to Respondent was not randomly selected because it was that of an undercover officer, the ALJ found credible the Diversion Investigator's testimony that the files were not specially selected to enhance the strength of the Government's case. ALJ at 5 (citing Tr. 768). More importantly, the requirement of Federal law that a prescription “must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice,” 21 CFR 1306.04(a), applies to each and every prescription issued by a practitioner. Thus, contrary to the Expert's understanding, in determining whether a practitioner has committed acts which render his “registration inconsistent with the public interest,” 21 U.S.C. 824(a)(4), DEA is not required to randomly select the files which it will base its case on.
For example, where the Government has developed information that particular patients are drug dealers or engaged in self-abuse, it is not required to ignore the files pertaining to these patients and base its case on a random sample of files. Rather, it can lawfully select the files pertaining to those patients and base its case entirely on them. Moreover, where the Government has seized files, it can review them and choose to present at the hearing only those files which evidence a practitioner's most egregious acts. Of course, where, as here, the Government's case relies so heavily on a chart review, the practitioner can put on his own evidence and argue that the Government's evidence does not establish that he violated the prescription requirement or that his conduct was not so egregious as to warrant revocation.
Finally, Respondent takes exception to the ALJ's findings that he violated Florida's standards for prescribing controlled substances. Resp. Exceptions at 4-5. More specifically, Respondent contends that he complied with the standards set forth under Florida regulations and that he “took a complete medical history and conducted a physical evaluation that was documented,” that he maintained “medical records documenting the
While it is true that Dr. Kennedy acknowledged that he was not familiar with the specific standard imposed by the State of Florida for excessive prescribing and that he had not reviewed any Florida Medical Board decisions addressing the issue of what is an adequate medical history,
As Dr. Kennedy explained, most of the patients were from out-of-state, with some travelling up to 1200 miles,
As Dr. Kennedy explained, while “[t]he chart was set up to give the appearance of a legitimate medical practice in an attempt to justify the initial and continued prescription and dispensing of high dose multiple controlled substances (`drug cocktails'),” and that while “on the surface [the charts] were adequate for evaluating and treating a patient,” on closer review, “the actual contents in the charts, clearly evidence[] just the opposite” as the charts “were very difficult * * * to read [with] many sections left blank or incompletely filled in.”
The evidence further shows that this case is not simply a matter of inadequate record keeping. While Respondent apparently required his patients to obtain an MRI, in multiple instances the MRI was obtained before the patient was even evaluated by Respondent, and generally, no other imaging studies such as x-rays or CT scans were done.
Dr. Kennedy further observed that while Respondent performed urine drug screens, he ignored the results even when they were inconsistent with other information provided by the patients such as when a patient tested positive for controlled substances which he had previously indicated that he was not currently taking.
Also, although the charts indicate that Respondent discussed doing yoga and stretching, using an anti-inflammatory diet, and taking several over-the-counter supplements (fish oil and glucosamine chondroitin), Respondent's treatment plan primarily involved prescribing “drug cocktails” of high doses of controlled substances with the same regimen of drugs (typically two strengths of oxycodone immediate release and Xanax) prescribed in nearly every case.
Dr. Kennedy further observed that while the typical starting dose of Xanax is 0.25 to 0.5 mg., once to twice per day, Respondent prescribed Xanax 2 mg., once or twice per day to fourteen of the sixteen patients, and he did so even with patients who had not been on the drug either “before or recently” and “no matter the age or clinical situation.”
Finally, Dr. Kennedy noted that beginning with a patient's first visit, Respondent prescribed very high initial doses of oxycodone. Dr. Kennedy explained that the usual starting dose for an opioid naïve patient in moderate to severe pain was five milligrams of oxycodone taken every four hours as needed for a total of thirty milligrams per day.
At each of J.S.'s subsequent visits, Respondent prescribed an additional thirty tablets of oxycodone 30 mg. (for a total of 210), along with sixty tablets of oxycodone 15 mg. and 60 tablets of Xanax 2 mg.
As Dr. Kennedy concluded, Respondent “was not engaged in the practice of medicine,” and “[t]he vast majority of [his] prescriptions for controlled substances was not for a legitimate medical purpose and w[as] beyond the boundaries of professional practice.”
Finally, I also reject Respondent's exception to the ALJ's ultimate finding that Respondent has committed acts which render his registration inconsistent with the public interest. Resp. Exc. 5. Because the record establishes that Respondent has repeatedly violated Federal law by issuing controlled substance prescriptions which lacked a legitimate medical purpose and were issued outside of the usual course of professional practice, 21 CFR 1306.04, and Respondent has offered no evidence establishing that he has accepted responsibility for his misconduct and that he has reformed his practice,
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 21 CFR 0.100(b) and 0.104, I order that DEA Certificate of Registration, FD1201196, issued to Roni Dreszer, M.D., be, and it hereby is, revoked. I further order that any pending application of Roni Dreszer, M.D., to renew or modify his registration, be, and it hereby is, denied. This Order is effective immediately.
John J. Mulrooney, II, Administrative Law Judge. On February 25, 2010, the Deputy Administrator, Drug Enforcement Administration (DEA or Government), issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO), immediately suspending the DEA Certificate of Registration (COR), Number FD1201196, of Roni Dreszer, M.D. (Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging that such registration constitutes an imminent danger to the public health and safety. The OSC/ISO also sought revocation of the Respondent's registration, pursuant to 21 U.S.C. 824(a)(4), and denial of any pending applications for renewal or modification of such registration, pursuant to 21 U.S.C. 823(f), alleging that the Respondent's continued registration is inconsistent with the public interest, as that term is used in 21 U.S.C. 823(f). On March 22, 2010, the Respondent timely requested a hearing, which, pursuant to a change of venue granted at his request was conducted in Miami, Florida, on July 7, 2010 through July 9, 2010.
The issue ultimately to be adjudicated by the Deputy Administrator, with the assistance of this recommended decision, is whether the record as a whole establishes by substantial evidence that Respondent's registration with the DEA should be revoked as inconsistent with the public interest as that term is used in 21 U.S.C. 823(f) and 824(a)(4). The Respondent's DEA practitioner registration expires by its terms on June 30, 2011.
After carefully considering the testimony elicited at the hearing, the admitted exhibits, the arguments of counsel, and the record as a whole, I have set forth my recommended findings of fact and conclusions below.
The OSC/ISO issued by the Government alleges that the Respondent, through the medical practice he participated in at American Pain, LLC (American Pain), prescribed and dispensed inordinate amounts of controlled substances, primarily oxycodone,
At the hearing, the Government presented the testimony of three witnesses, DEA Miami Field Division (MFD) Group Supervisor (GS) Susan
GS Langston testified that the investigation of the American Pain Clinic had its origins on November 30, 2009, during a routine inspection that she and a subordinate diversion investigator conducted at Appurtenance Biotechnology, LLC, a pharmacy doing business under the name Boca Drugs (Boca Drugs), and located a few blocks away from one of the former locations of American Pain. Tr. at 713, 717-20. According to Langston, an examination of the prescriptions seized from Boca Drugs revealed that the majority of those prescriptions were for oxycodone and alprazolam authorized over the signature of physicians associated with American Pain.
GS Langston also testified that, on March 3, 2010, a criminal search warrant was executed on the American Pain Clinic simultaneously with the OSC/ISO that initiated the present case. Tr. at 735. According to Langston, the items seized from American Pain included a sign that had been posted in what she believes to have served as the urinalysis waiting room.
Due to increased fraudulent prescriptions, [i]t's best if you fill your medication in Florida or your regular pharmacy. Don't go to a pharmacy in Ohio when you live in Kentucky and had the scripts written in Florida. The police will confiscate your scripts and hold them while they investigate. This will take up to 6 months. So only fill your meds in Florida or a pharmacy that you have been using for at least 3 months or more.
Please do
Langston also testified that while she was present in the American Pain offices, she noticed that each physician's desk was equipped with a group of stamps, each of which depicted a controlled substance medication with a corresponding medication usage instruction (sig). Tr. at 738-39. A photograph of one set of prescription script stamps was admitted as an exhibit.
GS Langston also testified that a great number of medical charts were seized from the American Pain offices, and that she and her staff selected a number of these files to be analyzed by a medical expert procured by the Government. Tr. at 762. According to GS Langston, after the execution of the warrant, the charts from the entire office were placed into piles in alphabetical order, and not separated by physician. Langston testified that she and three of her diversion investigators reviewed the seized files with a view towards choosing approximately fifteen files for each doctor with the aspirational criteria that each would reflect at least three to four visits by that doctor with a patient. Each investigator was empowered to place a chart on the selected pile, and when the target number (or about that number) was reached for each physician, the selection effort relative to that physician was deemed accomplished.
Langston also explained DEA's Automated Record Consolidated Ordering System (ARCOS) and testified that she generated an ARCOS report relative to the Respondent's ordering of controlled substances from January 2009 through February 2010. Govt. Ex. 97.
In the same fashion, Langston explained the purposes of and circumstances behind the generation of state prescription monitoring reports (PMPs) relative to the Respondent maintained by West Virginia, Kentucky, and Ohio. Govt. Exs. 98-100. Review of the PMP report data reflects that during the time period of February 1, 2006 through February 11, 2010, pharmacies filled 167 controlled substance prescriptions issued over the Respondent's signature to fifty-four patients located in West Virginia, 110 similar prescriptions provided to fifty-seven Kentucky-based patients were filled between January 1, 2009 and April 4, 2010, and sixty-six such prescriptions pertaining to twenty-eight patients located in Ohio were filled between April 1, 2008 and April 19, 2010.
No evidence was introduced at the hearing that would provide any reliable level of context regarding the raw data set forth in the databases received into evidence at the Government's request. Other than the observations noted above, no witness who testified at the hearing ever explained the significance of the data set forth in any of these databases to any issue that must or should be considered in deciding the present case. As discussed above, the fact that the Boca Drugs Prescription Log prepared by the agents does not distinguish between prescriptions authorized by the Respondent and another registrant of the same name deprives the document of virtually any relevance regarding the enforcement action against this Respondent.
GS Langston provided evidence that was sufficiently detailed, consistent and plausible to be deemed credible in this recommended decision.
SA Michael Burt testified that he has been employed by DEA since March 2004 and has been stationed with the Miami Field Division (MFD) since September 2004. Tr. at 813-14. Burt testified that he is the lead case agent for DEA in the investigation of American Pain Clinic and has participated in the investigation since the latter part of 2008. According to Burt, American Pain, which was previously known by the name South Florida Pain, has conducted business at four different locations, and
Based on these surveillance efforts, SA Burt testified concerning various activities he observed occurring outside the Boca and Lake Worth clinic locations, which were open to the public from 8 a.m. to 5 p.m. At the Boca location, Burt stated that on any given day, beginning at 7 a.m. in the morning, automobiles could be seen pulling into the parking lot and approximately twenty to thirty people were routinely lined up outside of the clinic waiting to gain admittance. Additionally, there was a steady stream of automobile and foot traffic in and out of the clinic throughout the day.
Based on his review of some (but not all)
SA Burt also testified regarding his review of some
SA Burt also testified that he received information from Dr. Eddie Sollie, a former physician employed during the time period American Pain was doing business as South Florida Pain, who terminated his employment at the Oakland Park clinic location in November or December 2008 after working there for approximately two and a half to three months.
SA Burt also provided testimony concerning three confidential sources (only one of whom was seen by the Respondent) and their contacts with doctors at American Pain. Relative to the Respondent, based on the investigative assistance he provided to the Palm Beach County, FL, Sheriff's Office (PBSO), Burt testified regarding the circumstances surrounding a confidential source's (CS3) visit to obtain controlled substances from
SA Burt also testified regarding the drug overdose deaths of TY and SM after obtaining controlled substances from American Pain.
Perhaps among the more striking aspects of SA Burt's performance on the witness stand is the anticipated testimony which he did not provide. When viewed in its entirety, SA Burt's record testimony was stunningly sparse when compared with his proposed testimony as noticed in the Government's prehearing statement.
Even apart from the marked contrast between the Burt testimony as proffered and as realized, his testimony was marred by periodic memory failures on significant issues and an inability to supply details to an extent that it could arguably have diminished the weight that could be fairly attached to those aspects of his own investigation that he did manage to recollect. During his testimony, SA Burt acknowledged his own marked lack of preparation and unfamiliarity with the investigation and confessed simply that “[t]here's no excuse . * * *”
Even acknowledging its obvious suboptimal aspects, SA Burt's testimony had no apparent nefarious motivation or indicia of intentional deceit. Burt came across as an earnest and believable witness, who, regarding the aspects of the case that he did recall, was able to impart substantial information about the investigation and activities involving American Pain and its doctors. While frequently lacking in detail, his testimony was not internally inconsistent or facially implausible, and although the legal weight I have assigned to certain portions of Burt's testimony varies given the issues described, I find his testimony to be credible overall.
The Government presented the bulk of its case through the report and testimony of its expert, L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.
Dr. Kennedy testified that after a review of a group of selected patient files from those seized at the Respondent's practice that were to him provided by the Government, he
Dr. Kennedy took professional issue with several aspects of the Respondent's patient care as reflected in the charts regarding the prescribing of controlled substances. It is apparent from his testimony that Dr. Kennedy's analysis is restricted to those matters which can be gleaned from an examination of the written word in that subset of the Respondent's patient charts provided by the Government for his review, and that limitation perforce circumscribes the breadth of his input. That being said, Dr. Kennedy highlighted numerous features in the Respondent's chart documentation that he found wanting, or at least remarkable.
Dr. Kennedy explained that there are basic elements to practicing pain medicine. The acquisition of a thorough history and physical examination is important.
[s]ometimes you have to help people understand why they're suffering or what their problems are. A person with an addiction or drug abuse problem is no worse a human being than me. I'm not any better than them. But it's your job as a doctor to sit down and find out what the truth is as well as you reasonably can under the circumstances.
Dr. Kennedy prepared a report in connection with the Government's case against the Respondent, which is dated April 30, 2010, and was admitted into evidence. Govt. Ex. 101; Tr. at 585. The report describes a general analysis of sixteen charts that the Respondent maintained on as many patients, that were (selected by and) provided to Dr. Kennedy by the Government from among patient files seized pursuant to a criminal search warrant executed at the Respondent's practice on March 3, 2010 (Patient Charts Analysis). Although this report purports to describe practices common to all sixteen files reviewed by Dr. Kennedy, much of the analysis is directed toward a chart prepared in connection with JS,
Dr. Kennedy's report makes it unambiguously clear that, in his opinion, all sixteen of the Respondent's charts that he reviewed suffered from the same shortcomings.
In Dr. Kennedy's opinion, the patient charts he reviewed that were prepared by the Respondent reflected care that fell below the applicable standard on multiple levels. In his report, Dr. Kennedy noted that the treatment notes in the charts: (1) Contained no typewritten clinical notes and were “very brief, difficult to read (often impossible) and not within the standard of care due to their brevity and quality”;
Dr. Kennedy found the Respondent's controlled substance patient monitoring to be deficient in numerous respects. From the reviewed patient charts, Dr. Kennedy gleaned that an initial, in-office urine drug screen was frequently executed during the patients' initial visit to the office but repeated only occasionally. Govt. Ex. 101 at 15. It was Dr. Kennedy's observation that even a drug screen anomaly did not alter the seemingly inexorable continuation of controlled substance prescribing from the Respondent.
The identified shortcomings of controlled substance patient monitoring systems was of particular significance where Dr. Kennedy identified specific evidence that he identified as “red flags” of possible or likely diversion. Red flags noted by Dr. Kennedy in the reviewed charts included the relatively young age of the Respondent's chronic pain patients,
Dr. Kennedy also found it remarkable that each American Pain patient file provided notice to its patients that American Pain did not accept any form of health care insurance. Govt. Ex. 101 at 3, 17. Dr. Kennedy's report set forth his opinion that this practice was designed to “effectively keep [the physicians at American Pain] `off the radar' from monitoring by any private health care insurance company as well as all state and federal agencies (Medicaid and Medicare respectively).
Regarding the discomfiture that Dr. Kennedy expressed regarding non-physician referrals in his report, during his testimony at the hearing, he clarified that it was not unusual for a physician to treat patients that have been referred by relatives and friends. Tr. at 154. Further, Kennedy conceded while in the course of his own medical practice he has treated patients referred by family and friends, and that in his report he was focusing on what he perceived as a lack of any referrals by physicians in the files he reviewed, or what he perceived as “trends” or “patterns.” Tr. at 154-55. Given Dr. Kennedy's acknowledgement that such referrals are not unusual, coupled with the absence of any record-evidence way to measure the relative percentage of physician referrals in the Respondent's practice, the observations regarding referral sources are of limited value here.
A review of the sixteen patient files that informed the analysis, findings and conclusions offered in Dr. Kennedy's written report and testimony does reflect the presence of at least some of the red flag issues he identified therein, but there was not the unanimity among the files that he repeatedly urges. For instance, in terms of evidence related to therapeutic plans, it is notable that Respondent's patient files contain at least some indications of recommended treatment modalities in addition to the Respondent's exclusive use of controlled substances for pain management. There are notations in the charts reflecting a patient was to see a “PCP,” or primary care physician, regarding jaundice, Govt. Ex. 108 at 9; in another patient file, a note listed under referrals reads “ER for eval of Cellulite + Possible IV ATBx.” Govt. Ex. 109 at 1.
An examination of the reviewed patient charts does reveal the presence of other red flags that should have inspired additional diligence or inquiry on the part of the Respondent. RR's patient file, for example, contains a form indicating a positive UDS for oxycodone and benzodiazepine from 11/20/08, yet on the same date, the medication contract signed by RR is blank in that portion of the form designated for the patient to reveal any medications he or she is currently taking. Govt. Ex. 105 at 15, 31;
In addition to the lack of adequately completed forms in some patient files noted by Dr. Kennedy, other patient files appear to be missing key documentation altogether. For instance,
Dr. Kennedy concluded his report regarding the Respondent's prescribing practices with the following summary:
[The Respondent] was not engaged in the practice of medicine, rather he was engaged in an efficient, “[a]ssembly [l]ine” business. His “patients” were revenue streams, not true patients. This business allowed him to collect cas[h] for office visits as well as being a “[d]ispensing [p]hysician” for controlled substances. He prescribed controlled substances so that “patients” would return to his office on a regular basis, allowing him to generate further revenue. [The Respondent's] routine and excessive prescription of multiple controlled substances (oxycodone and Xanax) and lack of arriving at a valid medical diagnosis and treatment most likely caused harm to the “patients” he saw. Drug diversion most likely caused a “mushroom” effect of increased drug abuse, drug addiction, drug overdoses, serious bodily injury and death in those communities spread over several different states. [The Respondent's] continued ability to prescribe controlled substances will only perpetuate the suffering and be a threat to the public.
On cross examination, Dr. Kennedy agreed that he assumed, for the purposes of his analysis, that where the Respondent's charts reflected an entry or a procedure, that the event actually occurred. Tr. at 654. Kennedy also acknowledged that every one of the patient files he reviewed contained at least a complaint of chronic pain symptoms by the patient and MRI results that could support such a diagnosis.
The Government's presentation of Dr. Kennedy's testimony at the hearing was substantially consistent with the conclusions included in the Patient Charts Analysis, but Dr. Kennedy's presentation was clearly not without its blemishes. Although he testified that he was familiar with prescribing practices in Florida, and that he utilized the medical standards applicable to Florida practice,
Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“[T]hese factors are considered in the disjunctive.”
In an action to revoke a registrant's DEA COR, the DEA has the burden of proving that the requirements for revocation are satisfied. 21 CFR 1301.44(e). Once DEA has made its
Where the Government has sustained its burden and established that a registrant has committed acts inconsistent with the public interest, that registrant must present sufficient mitigating evidence to assure the Deputy Administrator that he or she can be entrusted with the responsibility commensurate with such a registration.
The Agency's conclusion that past performance is the best predictor of future performance has been sustained on review in the courts,
While the burden of proof at this administrative hearing is a preponderance-of-the-evidence standard,
Regarding the exercise of discretionary authority, the courts have recognized that gross deviations from past agency precedent must be adequately supported,
In this case, it is undisputed that the Respondent holds a valid and current state license to practice medicine. The record contains no evidence of a recommendation regarding the Respondent's medical privileges by any cognizant state licensing board or professional disciplinary authority. However, that a state has not acted against a registrant's medical license is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest.
Similarly, regarding Factor 3, while testimony was received at the hearing that indicated that a criminal search warrant was executed regarding the Respondent and American Pain, the record contains no evidence that the Respondent has ever been convicted of any crime or even arrested in connection with any open criminal investigation. Thus, consideration of the record evidence under the first and third factors does not militate in favor of revocation.
In this case, the gravamen of the allegations in the OSC/ISO, as well as the factual concentration of much of the evidence presented, share as a principal focus the manner in which the Respondent has managed that part of his practice relative to prescribing and dispensing controlled substances and acts allegedly committed in connection with his practice at American Pain. Thus, it is analytically logical to consider public interest factors two, four and five together. That being said, factors two, four and five involve analysis of common and distinct considerations.
Regarding Factor 2, the qualitative manner and the quantitative volume in which a registrant has engaged in the dispensing of controlled substances, and how long he has been in the business of doing so are factors to be evaluated in reaching a determination as to whether
There are two principal considerations embedded within a consideration of this public interest factor. In considering a similar factor under the List I chemical context, the Agency has recognized that the level of experience held by those who will be charged with recognizing and taking steps to minimize diversion factors greatly in determining whether entrusting a COR will be in the public interest.
In this case, the Respondent introduced no evidence regarding his level of knowledge and experience, or even the quality or length of his experience as a physician-registrant, but the Government has elected to do so.
Regarding the Government's presentation, Agency precedent has long held that in DEA administrative proceedings that “the parameters of the hearing are determined by the prehearing statements.”
In like fashion, the Government's prehearing statement proffered that SA Burt would testify to several of the items described but not established in the OSC/ISO. Among the list of allegations that were not supported by any evidence introduced at the hearing, were representations that SA Burt would testify concerning the following:
Law enforcement in Florida and [other states that correspond to license plates seen in the American Pain parking lot] frequently arrest people for illegal possession and/or illegal distribution of controlled substances who have obtained the controlled substances from American Pain;
American Pain hired individuals to “roam” the parking lot of the clinic to dissuade people from selling their recently obtained controlled substances on the property;
[The reason American Pain placed] signs within American Pain warning individuals not to have their prescriptions filled at Walgreens pharmacies [is] because Walgreens refuses to dispense the prescriptions;
Walgreens has flagged all American Pain doctors and will not fill any of their prescriptions;
[Physical exams at American Pain are] usually no more than a blood pressure check and some bending and stretching;
Dismissed patients would be routed to other doctors within the clinic;
[There was] co-mingling of [American Pain] physician's drugs;
[American Pain maintained] no inventories of drugs dispensed;
[Details surrounding] the death of [American Pain] patient OB [where] [t]he cause of death was determined to be drug intoxication—opiate and benzodiazepine;
[Information] from a confidential source [who indicated] that she traveled to American Pain in order to obtain controlled substances that were later sold in Kentucky for $25 per pill[,] [that] [the American Pain physician she encountered] did not spend any significant time conducting a physical examination of [her] [,] [that she would simply ask questions regarding [her] well being and would then “stamp” a prescription for [controlled substances][,] * * * that on one visit [during a power failure a] security guard working for the clinic instructed everyone to be patient and that the doctors would be with them shortly to “get your fix.”
To be clear, it is not that the evidence was introduced and discredited; no evidence to support these (and other) allegations was introduced at all. To the extent the Government had this evidence, it left it home. While the stunning disparity between the allegations proffered and those that were supported with any evidence does not raise due process concerns, it is worthy of noting, without deciding the issue, that Agency precedent has acknowledged the Supreme Court's recognition of the applicability of the
The evidence the Government did present raises issues regarding not only Factor 2 (experience dispensing
While true that GS Langston convincingly testified about the course of her investigation and laid an adequate foundation for numerous database results, the Government provided no foundational context for any relevant uses for those database results. Even apart from the unfortunate reality that one of the databases contained data that could not be directly tied to this Respondent as opposed to another with the same last name, without some insight into what types of results from these databases should be expected when compared to similarly-situated registrants engaged in acceptable prescribing practices, the raw data is without use. In short, there was no evidence elicited wherein the percentage of the Respondent's in-state to out-of state patients could be assessed, and no reasonable measuring stick based on sound principles upon which to evaluate such data. Likewise, there was no reliable yardstick upon which to measure the amount of controlled substances reflected in the databases compared to what a reasonable regulator would expect to see regarding a compliant registrant. To the extent Langston possessed this information (and she well may have) it was not elicited from her. The same could be said of the allegation set forth in the Government's Prehearing Statement that alleges that from a given period the Respondent “was the 20th largest practitioner purchaser of oxycodone in the United States.”
SA Burt testified that, during a temporally limited period of time, he observed some of the images captured by a pole camera positioned outside American Pain, and that he observed what in his view was a high percentage of vehicles in the parking lot with out-of-state license tags. This testimony arguably provides some support for the Government's contention that out-of-state patients (or at least patients being dropped off by cars with out-of-state tags) were being seen at the clinic, but his testimony did not provide much else in terms of relevant information. In any event, recent Agency precedent holds that details such as “where [a registrant's] patients were coming from,” without additional factual development, can support a “strong suspicion that [a] respondent was not engaged in a legitimate medical practice” but that “under the substantial evidence test, the evidence must `do more than create a suspicion of the existence of the fact to be established.' ”
Likewise, without additional details or at least some context, Burt's testimony that individuals with “staff” written on their shirts appeared to be directing patients into the clinic reveals virtually nothing about the Respondent's prescribing practices. Tr. at 818, 910. Furthermore, that Burt observed an individual on a videotape, who he believed to be an American Pain employee, on a single occasion, instruct patients not to “snort [their] pills” in the parking lot,
Burt's testimony regarding his conversations with Dr. Sollie, who was formerly employed by American Pain, was also not received in a manner that could meaningfully assist in the decision process. According to Burt, Sollie told him that some (unnamed) physicians at American Pain were inadequately documenting their patient charts in some manner that was apparently never explained to Burt,
The Government's evidence targeted not only the Respondent's experience practicing under Factor 2, but also his compliance with applicable state and federal laws relating to controlled substances under Factor 4. To effectuate the dual goals of conquering drug abuse and controlling both legitimate and illegitimate traffic in controlled substances, “Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.”
A registered practitioner is authorized to dispense,
While true that the CSA authorizes the “regulat[ion] of medical practice so far as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood,”
Under the CSA, it is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to act “in the usual course of * * * professional practice” and to issue a prescription for a legitimate medical purpose.”
Under Florida law, grounds for disciplinary action or denial of state licensure include “prescribing * * * any controlled substance, other than in the course of the physician's professional practice,” and prescribing such substances “inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his or her intent.” Fla. Stat. § 458.331(q) (2009). Florida law further provides that grounds for such disciplinary action also include:
Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician * * * and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.
In exercising its rulemaking function,
(2) A licensed physician shall maintain patient medical records in English, in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken.
(3) The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.
(4) All entries made into the medical records shall be accurately dated and timed. Late entries are permitted, but must be clearly and accurately noted as late entries and dated and timed accurately when they are entered in to the record * * *.
With respect to defining the parameters of what constitutes “professional practice” in the context of pain management prescribing, Florida state law provides:
Notwithstanding any other provision of law, a physician may prescribe or administer any controlled substance under Schedules II-V * * * to a person for the treatment of intractable pain,
Like the
The Florida Standards direct that “[p]hysicians should be diligent in preventing the diversion of drugs for illegitimate purposes,”
The Florida Standards further provide that the validity of prescribing will be judged “based on the physician's treatment of the patient and
Although, as discussed above, the Florida Board instituted general guidance applicable to all physicians regarding medical records, it also promulgated a separate set of documentation requirements in the Florida Standards applicable specifically to those physicians who prescribe controlled substances in the pain-management context. The Florida Standards, under the subheading “Medical Records,” state that “[t]he physician is required to keep
1. The medical history and physical examination, including history of drug abuse or dependence, as appropriate;
2. Diagnostic, therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage, and quantity prescribed);
8. Instructions and agreements; and
9. Periodic reviews.
The Florida Standards similarly emphasize the need for proper documentation in the patient evaluation context by specifying:
A complete
Furthermore, the Florida Standards require a written treatment plan that “should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned.”
Another standard adopted by the Florida Board, under the subheading “Informed Consent and Agreement for Treatment,” is the directive that
1. Urine/serum medication levels screening when requested;
2. Number and frequency of all prescription refills; and
3. Reasons for which drug therapy may be discontinued (i.e., violation of agreement).
The Florida Standards contain a further requirement to periodically review “the course of pain treatment and any new information about the etiology of the pain or the patient's state of health.”
Continuation or modification of therapy depends on the physician's evaluation of the patient's progress. If treatment goals are not being achieved, despite medication
Under the subheading “Consultation,” the Florida Board promulgated the instruction that
[t]he physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients.
It is abundantly clear from the plain language of the Florida Standards that the Florida Board places critical emphasis on physician implementation of adequate safeguards in their practice to minimize diversion and the need to document the objective signs and rationale employed in the course of pain treatment utilizing the prescription of controlled substances. Conscientious documentation is repeatedly emphasized as not just a ministerial act, but a key treatment tool and a vital indicator to evaluate whether the
In his Post-Hearing Brief (Respondent's Brief), the Respondent's counsel has prepared and submitted a thoughtful and detailed review of one of the patient charts that was analyzed by Dr. Kennedy in his report. Respt's Br. at 22-26. While counsel argues that the patient chart entries were, at least by his interpretation of his client's obligations, satisfactory, the expert's opinion at the hearing remained unchanged. Even acknowledging, as this recommended decision does, that Dr. Kennedy's presentation was not without its deficiencies, its shortcomings do render it so fundamentally defective as to completely undermine his credibility and viability as within the scope of what a litigant may depend upon.
The Respondent, who was in a unique position to conclusively refute Dr. Kennedy's views and explain the format and nuances of the reviewed documentation, elected not to testify in this matter. At a DEA administrative hearing, it is permissible to draw an adverse inference from the silence of the Respondent, even in the face of a Fifth Amendment invocation.
In the Social Security context, where an Administrative Law Judge has received Expert medical opinions on the issue of the claimant's ability to work and they are not repudiated in any respect by substantial evidence, an adverse decision should be set aside as based on “suspicion and speculation.”
Accordingly, after carefully balancing the admitted evidence, the evidence establishes, by a preponderance, that the prescriptions the Respondent issued in Florida were not issued within “the usual course of [the Respondent's] professional practice.” 21 CFR 1306.04(a). Consideration of the evidence under the second and fourth factors support the COR revocation sought by the Government in this case.
To the extent that the Respondent's prescribing practices fell below the requisite standard in Florida, that conduct also impacts upon the Fifth statutory factor. Under Factor 5, the
The evidence establishes that the Respondent engaged in a course of practice wherein he prescribed controlled substances to patients irrespective of the patients' need for such medication and ignoring any and red flags that could or did indicate likely paths of diversion. The testimony of Dr. Kennedy, the DEA regulations, and the Florida Standards make clear that physicians prescribing controlled substances do so under an obligation to monitor the process to minimize the risk of diversion. The patient charts reflect that the Respondent, contrary to his obligations as a DEA registrant, did not follow up in the face of multiple red flags. The Respondent's disregard of his obligations as a DEA registrant and Federal and state laws related to controlled substances militate in favor of revocation.
By ignoring his responsibilities to monitor the controlled substance prescriptions he was authorizing to minimize diversion, and by participating in an insufficiently documented and thoughtful process for the issuance of potentially dangerous controlled substances, the Respondent created a significant potential conduit for the unchecked diversion of controlled substances.
Agency precedent has consistently held that where, as here, the Government has met its burden to establish a prima facie case that a registrant has committed acts demonstrating that continued registration is inconsistent with the public interest, acceptance of responsibility is a condition precedent to continued registration.
Based on the foregoing, the evidence supports a finding that the Government has established that the Respondent has committed acts that are inconsistent with the public interest. A balancing of the statutory public interest factors supports the revocation of the Respondent's Certificate of Registration and a denial of his application to renew. The Respondent has not accepted responsibility for his actions, expressed remorse for his conduct at any level, or presented evidence that could reasonably support a finding that the Deputy Administrator should continue to entrust him with a Certificate of Registration. Accordingly, the Respondent's Certificate of Registration should be revoked and any pending applications for renewal should be denied.
Dated: August 10, 2010.
On August 10, 2010, Administrative Law Judge (ALJ) John J. Mulrooney, II, issued the attached recommended decision.
Having reviewed the entire record including the ALJ's recommended decision, I have decided to adopt the ALJ's rulings, findings of fact,
In any event, Respondent offered no evidence on the issue of his experience in dispensing controlled substances and the ALJ's ultimate conclusion that Respondent violated the CSA's prescription requirement because she dispensed controlled substance prescriptions that were not “within ‘the usual course of [her] professional practice,’ ” ALJ at 39 (quoting 21 CFR 1306.04(a)), and that “the evidence under the [experience] * * * factor[] support[s]” the revocation of her registration, is consistent with Agency precedent.
With respect to factor five, “[s]uch other conduct which may threaten public health and safety,” 21 U.S.C. 823(f)(5), the ALJ opined that “an adverse finding under this factor requires some showing that the relevant conduct
The ALJ also opined that “[i]t is clear that in assessing whether the controlled substance prescribing practices of a Florida practitioner fall within the acceptable range of what constitutes being within the bounds of being ‘issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice,’ resort must be had to an expert.” ALJ at 34 (quoting 21 CFR 1306.04(a)). While the ALJ properly noted the importance of expert testimony in this case, in which the Government primarily relied on a review of the medical charts, whether expert testimony is needed is necessarily dependent on the nature of the allegations and the other evidence in the case. Where, for example, the Government produces evidence of undercover visits showing that a physician knowingly engaged in outright drug deals, expert testimony adds little to the proof necessary to establish a violation of Federal law.
Pursuant to the authority vested in me by 21 U.S.C. 823(f) and 824(a), as well as 21 CFR 0.100(b) and 0.104, I order that DEA Certificate of Registration, BC8112637, issued to Cynthia M. Cadet, M.D., be, and it hereby is revoked. I further order that any pending application of Cynthia M. Cadet, M.D., to renew or modify his registration, be, and it hereby is, denied.
This Order is effective immediately.
John J. Mulrooney, II, Administrative Law Judge. On February 25, 2010, the Deputy Administrator, Drug Enforcement Administration (DEA or Government), issued an Order to Show Cause and Immediate Suspension of Registration (OSC/ISO), immediately suspending the DEA Certificate of Registration (COR), Number BC8112637, of Cynthia M. Cadet, M.D. (Respondent), as a practitioner, pursuant to 21 U.S.C. 824(d), alleging that such registration constitutes an imminent danger to the public health and safety. The OSC/ISO also sought revocation of the Respondent's registration, pursuant to 21 U.S.C. 824(a)(4), and denial of any pending applications for renewal or modification of such registration, pursuant to 21 U.S.C. 823(f), alleging that the Respondent's continued registration is inconsistent with the public interest, as that term is used in 21 U.S.C. 823(f). On March 22, 2010, the Respondent timely requested a hearing, which, pursuant to a change of venue granted at her request, was conducted in Miami, Florida, on July 7, 2010 through July 9, 2010.
The issue ultimately to be adjudicated by the Deputy Administrator, with the assistance of this recommended decision, is whether the record as a whole establishes by substantial evidence that Respondent's registration with the DEA should be revoked as inconsistent with the public interest as that term is used in 21 U.S.C. §§ 823(f) and 824(a)(4). The Respondent's DEA practitioner registration expires by its terms on August 31, 2011.
After carefully considering the testimony elicited at the hearing, the admitted exhibits, the arguments of counsel, and the record as a whole, I have set forth my recommended findings of fact and conclusions below.
The OSC/ISO issued by the Government alleges that the Respondent, through the medical practice she had been participating in at American Pain, LLC (American Pain), has prescribed and dispensed inordinate amounts of controlled substances, primarily oxycodone,
At the hearing, the Government presented the testimony of three witnesses, DEA Miami Field Division (MFD) Group Supervisor (GS) Susan Langston, DEA Special Agent (SA) Michael Burt, and L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.
GS Langston testified that the investigation of the American Pain Clinic had its origins on November 30, 2009, during a routine inspection that she and a subordinate diversion investigator conducted at Appurtenance Biotechnology, LLC, a pharmacy doing business under the name Boca Drugs (Boca Drugs), and located a few blocks away from one of the former locations of American Pain. Tr. at 713, 717-20. According to Langston, an examination of the prescriptions seized from Boca Drugs revealed that the majority of those prescriptions were for oxycodone and alprazolam authorized over the signature of physicians associated with American Pain.
GS Langston also testified that, on March 3, 2010, a criminal search warrant was executed on the American Pain Clinic simultaneously with the OSC/ISO that initiated the present case.
Due to increased fraudulent prescriptions, [i]t's best if you fill your medication in Florida or your regular pharmacy. Don't go to a pharmacy in Ohio when you live in Kentucky and had the scripts written in Florida. The police will confiscate your scripts and hold them while they investigate. This will take up to 6 months. So only fill your meds in Florida or a pharmacy that you have been using for at least 3 months or more.
Please do
Langston also testified that while she was present in the American Pain offices, she noticed that each physician's desk was equipped with a group of stamps, each of which depicted a controlled substance medication with a corresponding medication usage instruction (sig). Tr. at 738-39. A photograph of one set of prescription script stamps was admitted as an exhibit.
GS Langston also testified that a great number of medical charts were seized from the American Pain offices, and that she and her staff selected a number of these files to be analyzed by a medical expert procured by the Government. Tr. at 762. According to GS Langston, after the execution of the warrant, the charts from the entire office were placed into piles in alphabetical order, and not separated by physician. Langston testified that she and three of her diversion investigators reviewed the seized files with a view towards choosing approximately fifteen files for each doctor with the aspirational criteria that each would reflect at least three to four visits by that doctor with a patient. Each investigator was empowered to place a chart on the selected pile, and when the target number (or about that number) was reached for each physician, the selection effort relative to that physician was deemed accomplished.
Langston also explained DEA's Automated Record Consolidated Ordering System (ARCOS)
In the same fashion, Langston explained the purposes of and circumstances behind the generation of State prescription monitoring reports (PMPs) relative to the Respondent maintained by West Virginia, Kentucky, and Ohio. Govt. Exs. 51-53. Review of the PMP report data reflects that during the time period of February 1, 2006 through February 11, 2010, pharmacies filled 166 controlled substance prescriptions issued over the Respondent's signature to fifty patients located in West Virginia, 124 similar prescriptions provided to fifty-one Kentucky-based patients were filled between January 1, 2009 and April 4, 2010, and fifty-five such prescriptions pertaining to twenty-eight patients located in Ohio were filled between April 1, 2008 and April 19, 2010.
No evidence was introduced at the hearing that would provide any reliable level of context regarding the raw data set forth in the databases received into evidence at the Government's request. Other than the observations noted above, no witness who testified at the hearing ever explained the significance of the data set forth in any of these databases to any issue that must or should be considered in deciding the present case.
GS Langston provided evidence that was sufficiently detailed, consistent and plausible to be deemed credible in this recommended decision.
SA Michael Burt testified that he has been employed by DEA since March 2004 and has been stationed with the Miami Field Division (MFD) since September 2004. Tr. at 813-14. Burt testified that he is the lead case agent for DEA in the investigation of American Pain Clinic and has participated in the investigation since the latter part of 2008. According to Burt, American Pain, which was previously known by the name South Florida Pain, has conducted business at four different locations, and he surveilled the Boca Raton and Lake Worth locations both in person and by periodic live review of video captured via pole cameras
Based on these surveillance efforts, SA Burt testified concerning various activities he observed occurring outside the Boca and Lake Worth clinic locations, which were open to the public from 8 a.m. to 5 p.m. At the Boca location, Burt stated that on any given day, beginning at 7 a.m. in the morning, automobiles could be seen pulling into the parking lot and approximately twenty to thirty people were routinely lined up outside of the clinic waiting to gain admittance. Additionally, there was a steady stream of automobile and foot traffic in and out of the clinic throughout the day.
Based on his review of some (but not all)
SA Burt also testified regarding his review of some
SA Burt also testified that he received information from Dr. Eddie Sollie, a former physician employed during the time period American Pain was doing business as South Florida Pain, who terminated his employment at the Oakland Park clinic location in November or December 2008 after working there for approximately two and a half to three months.
The Government also presented evidence through the testimony of SA Burt regarding the drug overdose deaths of TY and SM after obtaining controlled substances from American Pain.
SA Burt also testified that TFO Adams notified him about the overdose death of SM, whose body was found at his Kentucky home.
The certificate of death contained in the RCSO Investigation reflects the coroner's finding of “acute Oxycodone and Alprazolam intoxication” as SM's cause of death. Govt. Ex. 54 at 2; Respt. Ex. 1 at 7-8. The RCSO Investigation includes a narrative report, which states that the responding police officer reporting the incident procured various statements and paperwork from the decedent's parents indicating he “had been going to a pain clinic in Ft. Lauderdale, FL [t]o receive pain medication,” copied said documents, and placed them in his case file.
Also absent from the Government's version of the RCSO Investigation is that several prescription vials were found on SM's body at the time of his death. One empty prescription vial indicates that it had once contained forty-five hydrocodone pills filled on December 2, 2008 (twenty-eight days prior to his death and twenty-seven days prior to his first and only appointment with the Respondent), another empty hydrocodone vial indicates that it was filled on November 21, 2008 (forty-one days prior to his death and forty days prior to his first and only appointment with the Respondent), and a third vial of tizanidine (a non-controlled substance) was filled on November 19, 2008 (forty-three days prior to his death and forty-two days prior to his first and only appointment with the Respondent). Also found on the Respondent was a vial with what appeared to be marijuana seeds, baggies and a scale of a type that is commonly used in connection with drug paraphernalia. Respt. Ex. 1 at 4.
Statements of interviews contained in the RCSO Investigation reflect that SM's friends and family were aware that he had a pain-killer addiction that had its origins in the treatment of pain symptoms from an automobile accident and that he abused marijuana.
Although the coroner unambiguously concluded that “[a]cute Oxycodone and Alprazolam intoxication” was the cause of death,
When viewed in its entirety, SA Burt's record testimony was stunningly sparse when compared with his proposed testimony as noticed in the Government's prehearing statement.
Even apart from the marked contrast between the Burt testimony as proffered and as realized, his testimony was marred by periodic memory failures on significant issues and an inability to supply details to an extent that it could arguably have diminished the weight that could be fairly attached to those aspects of his own investigation that he did manage to recollect. During his testimony, SA Burt acknowledged his own marked lack of preparation and unfamiliarity with the investigation and confessed simply that “[t]here's no excuse * * *.”
Even acknowledging its obvious suboptimal aspects, SA Burt's testimony had no apparent nefarious motivation or indicia of intentional deceit. Burt came across as an earnest and believable witness, who, regarding the aspects of the case that he did recall, was able to impart substantial information about the investigation and activities involving American Pain and its doctors. While frequently lacking in detail, his testimony was not internally inconsistent or facially implausible, and although the legal weight I have assigned to certain portions of Burt's testimony varies given the issues described, I find his testimony to be credible overall.
The Government presented the bulk of its case through the report and testimony of its expert, L. Douglas Kennedy, M.D., D.A.B.P.M., Affiliate Clinical Assistant Professor at the University of Miami, Miller School of Medicine.
Dr. Kennedy testified that after a review of a group of selected patient files from those seized at the Respondent's practice that were to him provided by the Government, he concluded that the charts lacked the individualized treatment plans and the variety of diagnostic tools required to meet the minimally acceptable standards of practice in the State of Florida, that Respondent's prescribing practices and the documentation present in those patient files fell below the standards fixed by the Florida State Medical Board, and that the controlled substance prescriptions contained in those files were not issued for a legitimate medical purpose.
At the hearing, Dr. Kennedy explained that he took professional
Dr. Kennedy explained that there are basic elements to practicing pain medicine. The acquisition of a thorough history and physical examination is important.
[s]ometimes you have to help people understand why they're suffering or what their problems are. A person with an addiction or drug abuse problem is no worse a human being than me. I'm not any better than them. But it's your job as a doctor to sit down and find out what the truth is as well as you reasonably can under the circumstances.
In his testimony, Dr. Kennedy related that, in his expert opinion, although the information in the charts required a prudent physician to seek out prior medical records and/or input from prior medical providers, none of the Respondent's charts reflected any attempt to do so.
Kennedy also explained the importance of establishing a differential or working diagnosis on the first visit and modifying and reviewing that diagnosis as more information and results become available.
In Kennedy's view, the treatment plans in the Respondent's chart were also infirm in that they were not sufficiently individualized.
basically it's the same. [The patients are] given high-dose oxycodone and two different strengths. The Roxicodone 15 milligrams is twice a day. The Roxicodone 30 looks like it's been given six times a day in one case and eight times a day in another. Xanax is given at 2 miligrams.
Although Dr. Kennedy conceded that it is the judgment of the examining physician that is generally relied upon in determining the necessity and appropriateness of diagnostic testing,
While acknowledging that some standardization and utilization of forms is not, standing alone, improper,
Dr. Kennedy prepared two reports in connection with the Government's case against the Respondent, which are dated April 28 and April 30, 2010, respectively, and both of which were admitted into evidence. Govt. Exs. 55, 132; Tr. at 381-82. One of the reports describes a general analysis of thirteen charts that the Respondent maintained on as many patients, that were (selected by and) provided to Dr. Kennedy by the Government from among patient files seized pursuant to a criminal search warrant executed at the Respondent's practice on March 3, 2010 (Patient Charts Analysis). Govt. Ex. 55. Although this report purports to describe practices common to all thirteen files reviewed by Dr. Kennedy, much of the analysis is directed toward a chart prepared in connection with RA,
Many of the observations and conclusions contained within the two reports are remarkably similar. Dr. Kennedy's report makes it unambiguously clear that, at least in his opinion, all fourteen of the Respondent's charts that he reviewed suffered from the same shortcomings. The Patient Charts Analysis states that the Respondent's patient charts reviewed by Dr. Kennedy “are essentially the same with regard to review issues; as stated in the report of [RA] referenced and discussed in this report in detail, [and that] there were no significant differences that affected [his] conclusions and summary.” Govt. Ex. 55 at 2. A like-worded proviso accompanies Dr. Kennedy's analysis of
It is interesting to note that the SM patient chart contains no indication that the Respondent made any efforts to contact any prior doctors, pharmacists or family members. Likewise, there is no indication that any effort was made to query Kentucky PMP databases. A check to any of these sources could have informed the Respondent that another physician had recently prescribed oxycodone and other medications to SM, that SM was, at least in the opinion of his family and friends, addicted to pain medicine and was abusing marijuana, and that SM was emotionally labile due to the recent estrangement he had with his girlfriend. Unfortunately, because the Respondent made no efforts to reach out for any of that information, she merely talked to SM, prescribed controlled substances, and SM perished by an overdose of the same variety of medication she prescribed.
In Dr. Kennedy's opinion, the patient charts he reviewed that were prepared by the Respondent reflected care that fell below the applicable standard on multiple levels. In his report, Dr. Kennedy noted that the treatment notes in the charts: (1) Contained no typewritten clinical notes and were “very brief, difficult to read (often impossible) and not within the standard of care due to their brevity and quality;
in effect, acted as a `barrier' for [RA] to receive appropriate medical evaluation and treatment. In other words, the very potent, high doses of opioids (oxycodone) and benzodiazepine (Xanax) could cover up [RA's] underlying disease process(s), making it more difficult to diagnose, and allowing the disease(s) to unnecessarily worsen. Without an accurate diagnosis, all [the Respondent] was doing was, again, masking or covering up the symptoms.
Dr. Kennedy found the Respondent's controlled substance patient monitoring to be deficient in numerous respects. From the reviewed patient charts, Dr. Kennedy gleaned that an initial, in-office urine drug screen was frequently executed during the patients' initial visit to the office but repeated only occasionally. Govt. Ex. 55 at 14. It was Dr. Kennedy's observation that even a drug screen anomaly did not alter the seemingly inexorable continuation of controlled substance prescribing from the Respondent.
The identified shortcomings of controlled substance patient monitoring systems was of particular significance where Dr. Kennedy identified specific evidence that he identified as “red flags” of possible or likely diversion. In addition to providing incomplete and/or inconsistent information on his patient questionnaires, SM's file reflected a positive urine screen test for the presence of benzodiazepines, opiates, and oxycodone, significant potential depression, and the failure to disclose information about his Kentucky-based primary care and orthopedics treating physicians, and his physical therapist. Govt. Exs. 69, 132 at 6. Other red flags noted by Dr. Kennedy in the reviewed charts included the relatively young age of the Respondent's chronic pain patients,
During the course of his testimony, Dr. Kennedy highlighted evidence in the chart of patient RA reflecting that although he disclosed to the Respondent that he was currently taking oxycodone and Xanax, and had last been prescribed a dosage that should have still been sufficient to supply him with medication on the day of his first office
Similarly, Dr. Kennedy explained that regarding RR's patient chart, the paperwork generated at the time of the first visit with the Respondent reflected that he had been prescribed controlled substance medications that should have, but did not, yield positive urinalysis results.
Although Dr. Kennedy agreed during cross examination that a possible explanation for a negative urinalysis could be that the medication was not taken within a few days of the urinalysis,
The duty was to talk with the—the first thing you do is talk with the person, the individual, the patient, and find out if they have an explanation for that; was it a misunderstanding? Did they mean what they wrote down? And find out exactly what's going on and get their side, get their story, because your job is to advocate for them, and also, to help them from doing any harm to themselves.
In his report, Dr. Kennedy also found it remarkable that each American Pain patient file provided notice to its patients that American Pain did not accept any form of health care insurance. Govt. Ex. 55 at 3-4, 16. Dr. Kennedy's report set forth his opinion that this practice was designed to “effectively keep [the physicians at American Pain] `off the radar' from monitoring by any private health care insurance company as well as all State and Federal agencies (Medicaid and Medicare respectively). Govt. Ex. 55 at 16. Significantly, however, when asked, Dr. Kennedy acknowledged that he conducts his own current medical practice on a cash-only basis. Tr. at 151.
Regarding the discomfiture that Dr. Kennedy expressed regarding non-physician referrals in his report, during his testimony at the hearing, he clarified that it was not unusual for a physician to treat patients that have been referred by relatives and friends.
Dr. Kennedy concluded his report regarding the Respondent's prescribing practices with the following summary:
[The Respondent] was not engaged in the practice of medicine, rather [s]he was engaged in an efficient, “[a]ssembly [l]ine” business. H[er] “patients” were revenue streams, not true patients. This business allowed h[er] to collect cas[h] for office visits as well as being a “[d]ispensing [p]hysician” for controlled substances. [Sh]e prescribed controlled substances so that “patients” would return to h[er] office on a regular basis, allowing h[er] to generate further revenue. [The Respondent's] routine and excessive prescription of multiple controlled substances (oxycodone and Xanax) and lack of arriving at a valid medical diagnosis and treatment most likely caused harm to the “patients” [s]he saw. Drug diversion most likely caused a “mushroom” effect of increased drug abuse, drug addiction, drug overdoses, serious bodily injury and death in those communities spread over several different states. [The Respondent's] continued ability to prescribe controlled substances will only perpetuate the suffering and be a threat to the public.
On cross examination at the hearing, Dr. Kennedy's attention was directed to what would seem, at least to a lay person, to present as including a significant level of detail set forth in the charts he reviewed relative to the Respondent's patient documentation, including both subjective complaints of discomfort and objective signs of medical anomalies. Tr. at 497-98, 532-42. Undaunted, Dr. Kennedy (the sole expert to testify at the hearing), remained committed to his position that the manner in which the documentation was completed was fundamentally insufficient and too omission-plagued for a physician to adequately proceed to treat the patients with controlled substances.
The Supplemental Chart Analysis focused exclusively on SM's chart, which contained information assembled on the date of his first and only visit to the Respondent's practice, which occurred on the day before he was pronounced dead of an overdose of the controlled substances prescribed to him by the Respondent. Govt. Exs. 69 at 10, 132, 54; Respt. Ex. 1. Among the deficiencies noted by Dr. Kennedy regarding SM's chart was an absence of any efforts to communicate with SM's prior physician or obtain prior medical records, and SM's failure to list any medications on the applicable portion of the medication contract. Govt. Ex. 132. Kennedy also opined that SM's failure to provide any contact information regarding his prior physician, who, like SM was located in Kentucky, should have presented a red flag to the
A review of the fourteen patient files
Regarding Dr. Kennedy's objections to what he perceives as a virtually uniform pattern in the Respondent's therapeutic plans, the record is not without exception. For example, Respondent included notations in one patient's records referring him to see an oncologist based on potential liver cancer concerns. Govt. Ex. 68 at 9.
An examination of the reviewed patient charts does reveal the presence of other red flags that should have inspired additional diligence or inquiry on the part of the Respondent. GA's patient file contains a notation about the patient getting Roxicodone, Xanax, and Percocet “off the street,” a patient comfort assessment guide where GA states that his current treatments or medicine include “street drugs,” a medication contract that is signed but does not list any current medications at all, along with an initial positive urinalysis screen for opiates and oxycodone, yet the Respondent decided to prescribe all three substances to GA during his initial and subsequent visits. Govt. Ex. 58 at 8-9, 11, 35;
Patient JA's file also contains an indication that he had previously received pain medications “off the street,” along with a police incident report referring to the armed robbery of two “Roxycotin” (sic) prescriptions valued at $600 from the patient on 12/31/09 (the same date on which the Respondent provided them to him), and which further contains a statement that “[t]he victim completed a written statement affidavit, but refused to pursue criminal charges at this time.”
JA's patient file also contains a form indicating a positive UDS for oxycodone and benzodiazepine from 10/7/09, yet on the same date, the patient comfort assessment guide and medication contract signed by JA are both blank in the section where a patient is supposed to list any medications he or she is currently taking. Govt. Ex. 56 at 13-14, 30;
The Government's presentation of Dr. Kennedy's testimony at the hearing was substantially consistent with the conclusions included in the Patient Charts Analysis, but Dr. Kennedy's presentation was clearly not without its blemishes. Although he testified that he was familiar with prescribing practices in Florida, and that he utilized the medical standards applicable to Florida practice,
Pursuant to 21 U.S.C. 824(a)(4), the Deputy Administrator
(1) The recommendation of the appropriate State licensing board or professional disciplinary authority.
(2) The applicant's experience in dispensing, or conducting research with respect to controlled substances.
(3) The applicant's conviction record under Federal or State laws relating to the manufacture, distribution, or dispensing of controlled substances.
(4) Compliance with applicable State, Federal or local laws relating to controlled substances.
(5) Such other conduct which may threaten the public health and safety.
“[T]hese factors are considered in the disjunctive.”
In an action to revoke a registrant's DEA COR, the DEA has the burden of proving that the requirements for revocation are satisfied. 21 CFR 1301.44(e). Once DEA has made its
Where the Government has sustained its burden and established that a registrant has committed acts inconsistent with the public interest, that registrant must present sufficient mitigating evidence to assure the Deputy Administrator that he or she can be entrusted with the responsibility commensurate with such a registration.
The Agency's conclusion that past performance is the best predictor of future performance has been sustained on review in the courts,
While the burden of proof at this administrative hearing is a preponderance-of-the-evidence standard,
Regarding the exercise of discretionary authority, the courts have recognized that gross deviations from past agency precedent must be adequately supported,
In this case, it is undisputed that the Respondent holds a valid and current State license to practice medicine. The record contains no evidence of a recommendation regarding the Respondent's medical privileges by any cognizant State licensing board or professional disciplinary authority. However, that a State has not acted against a registrant's medical license is not dispositive in this administrative determination as to whether continuation of a registration is consistent with the public interest.
Similarly, regarding Factor 3, while testimony was received at the hearing that indicated that a criminal search warrant was executed regarding the Respondent and American Pain, the record contains no evidence that the Respondent has ever been convicted of any crime or even arrested in connection with any open criminal investigation. Thus, consideration of the record evidence under the first and third factors does not militate in favor of revocation.
In this case, the gravamen of the allegations in the OSC/ISO, as well as the factual concentration of much of the evidence presented, share as a principal focus the manner in which the Respondent has managed that part of her practice relative to prescribing and dispensing controlled substances and acts allegedly committed in connection with her practice at American Pain. Thus, it is analytically logical to consider public interest factors two, four and five together. That being said, factors two, four and five involve analysis of common and distinct considerations.
Regarding Factor 2, the qualitative manner and the quantitative volume in which a registrant has engaged in the dispensing of controlled substances, and how long she has been in the business of doing so are factors to be evaluated in reaching a determination as to whether she should be entrusted with a DEA certificate. In some cases, viewing a registrant's actions against a backdrop of how she has performed activity within the scope of the certificate can provide a contextual lens to assist in a fair adjudication of whether continued registration is in the public interest.
There are two principal considerations embedded within a consideration of this public interest factor. In considering a similar factor under the List I chemical context, the Agency has recognized that the level of experience held by those who will be charged with recognizing and taking steps to minimize diversion factors greatly in determining whether entrusting a COR will be in the public interest.
In this case, the Respondent introduced no evidence regarding her level of knowledge and experience, or even the quality or length of her experience as a physician-registrant, but the Government has elected to do so.
Regarding the Government's presentation, Agency precedent has long held that in DEA administrative proceedings “the parameters of the hearing are determined by the prehearing statements.”
In like fashion, the Government's prehearing statement proffered that SA Burt would testify to several of the items described but not established in the OSC/ISO. Among the list of allegations that were
Law enforcement in Florida and [other states that correspond to license plates seen in the American Pain parking lot] frequently arrest people for illegal possession and/or illegal distribution of controlled substances who have obtained the controlled substances from American Pain;
American Pain hired individuals to “roam” the parking lot of the clinic to dissuade people from selling their recently obtained controlled substances on the property;
[The reason American Pain placed] signs within American Pain warning individuals not to have their prescriptions filled at Walgreens pharmacies [is] because Walgreens refuses to dispense the prescriptions;
Walgreens has flagged all American Pain doctors and will not fill any of their prescriptions;
[Physical exams at American Pain are] usually no more than a blood pressure check and some bending and stretching;
Dismissed patients would be routed to other doctors within the clinic;
[There was] co-mingling of [American Pain] physician's drugs;
[American Pain maintained] no inventories of drugs dispensed;
[Details surrounding] the death of [American Pain] patient OB [where] [t]he cause of death was determined to be drug intoxication—opiate and benzodiazepine;
[Information] from a confidential source [who indicated] that she traveled to American Pain in order to obtain controlled substances that were later sold in Kentucky for $25 per pill[,] [that] [the American Pain physician she encountered] did not spend any significant time conducting a physical examination of [her] [,] [that she would simply ask questions regarding [her] well being and would then “stamp” a prescription for [controlled substances][,] * * * that on one visit [during a power failure a] security guard working for the clinic instructed everyone to be patient and that the doctors would be with them shortly to “get your fix.”
To be clear, it is not that the evidence was introduced and discredited; no evidence to support these (and other) allegations was introduced at all. To the extent the Government had this evidence, it left it home. While the stunning disparity between the allegations proffered and those that were supported with any evidence does not raise due process concerns, it is worthy of noting, without deciding the issue, that Agency precedent has acknowledged the Supreme Court's recognition of the applicability of the
The evidence the Government did present raises issues regarding not only Factor 2 (experience dispensing
While true that GS Langston convincingly testified about the course of her investigation and laid an adequate foundation for numerous database results, the Government provided no foundational context for any relevant uses for those database results. Without some insight into what types of results from these databases should be expected when compared to similarly-situated registrants engaged in acceptable prescribing practices, the raw data is without use. In short, there was no evidence elicited wherein the percentage of the Respondent's in-State to out-of State patients could be assessed, and no reasonable measuring stick based on sound principles upon which to evaluate such data. Likewise, there was no reliable yardstick upon which to measure the amount of controlled substances reflected in the databases compared to what a reasonable regulator would expect to see regarding a compliant registrant. To the extent Langston possessed this information (and she well may have) it was not elicited from her. The same could be said of the allegation set forth in the Government's Prehearing Statement that alleges that from a given period the Respondent “was the 12th largest practitioner purchaser of oxycodone in the United States.”
SA Burt testified that, during a temporally limited period of time, he observed some of the images captured by a pole camera positioned outside American Pain, and that he observed what in his view was a high percentage of vehicles in the parking lot with out-of-State license tags. This testimony arguably provides some support for the Government's contention that out-of-State patients (or at least patients being dropped off by cars with out-of-State tags) were being seen at the clinic, but his testimony did not provide much else in terms of relevant information. In any event, recent Agency precedent holds that details such as “where [a registrant's] patients were coming from,” without additional factual development, can support a “strong suspicion that [a] respondent was not engaged in a legitimate medical practice” but that “under the substantial evidence test, the evidence must `do more than create a suspicion of the existence of the fact to be established.' ”
Likewise, without additional details or at least some context, Burt's testimony that individuals with “staff” written on their shirts appeared to be directing patients into the clinic reveals virtually nothing about the Respondent's prescribing practices. Tr. at 818, 910. Furthermore, that Burt observed an individual on a videotape, who he believed to be an American Pain employee, on a single occasion, instruct patients not to “snort [their] pills” in the parking lot,
Burt's testimony regarding his conversations with Dr. Sollie, who was formerly employed by American Pain, was also not received in a manner that could meaningfully assist in the decision process. According to Burt, Sollie told him that some (unnamed) physicians at American Pain were inadequately documenting their patient charts in some manner that was apparently never explained to Burt,
The Government's evidence targeted not only the Respondent's experience practicing under Factor 2, but also her compliance with applicable State and Federal laws relating to controlled substances under Factor 4. To effectuate the dual goals of conquering drug abuse and controlling both legitimate and illegitimate traffic in controlled substances, “Congress devised a closed regulatory system making it unlawful to manufacture, distribute, dispense, or possess any controlled substance except in a manner authorized by the CSA.”
A registered practitioner is authorized to dispense,
While true that the CSA authorizes the “regulat[ion] of medical practice so far as it bars doctors from using their prescription-writing powers as a means to engage in illicit drug dealing and trafficking as conventionally understood,”
Under the CSA, it is fundamental that a practitioner must establish a bonafide doctor-patient relationship in order to act “in the usual course of * * * professional practice” and to issue a prescription for a legitimate medical purpose.”
Under Florida law, grounds for disciplinary action or denial of State licensure include “prescribing * * * any controlled substance, other than in the course of the physician's professional practice,” and prescribing such substances “inappropriately or in excessive or inappropriate quantities is not in the best interest of the patient and is not in the course of the physician's professional practice, without regard to his or her intent.” Fla. Stat. § 458.331(q) (2009). Florida law further provides that grounds for such disciplinary action also include:
Failing to keep legible, as defined by department rule in consultation with the board, medical records that identify the licensed physician * * * and that justify the course of treatment of the patient, including, but not limited to, patient histories; examination results; test results; records of drugs prescribed, dispensed, or administered; and reports of consultations and hospitalizations.
In exercising its rulemaking function,
(2) A licensed physician shall maintain patient medical records in English, in a legible manner and with sufficient detail to clearly demonstrate why the course of treatment was undertaken.
(3) The medical record shall contain sufficient information to identify the patient, support the diagnosis, justify the treatment and document the course and results of treatment accurately, by including, at a minimum, patient histories; examination results; test results; records of drugs prescribed, dispensed or administered; reports of consultations and hospitalizations; and copies of records or reports or other documentation obtained from other health care practitioners at the request of the physician and relied upon by the physician in determining the appropriate treatment of the patient.
(4) All entries made into the medical records shall be accurately dated and timed. Late entries are permitted, but must be clearly and accurately noted as late entries and dated and timed accurately when they are entered in to the record * * *.
With respect to defining the parameters of what constitutes “professional practice” in the context of pain management prescribing, Florida State law provides:
Notwithstanding any other provision of law, a physician may prescribe or administer
Like the
The Florida Standards direct that “[p]hysicians should be diligent in preventing the diversion of drugs for illegitimate purposes,”
The Florida Standards further provide that the validity of prescribing will be judged “based on the physician's treatment of the patient and
Although, as discussed above, the Florida Board instituted general guidance applicable to all physicians regarding medical records, it also promulgated a separate set of documentation requirements in the Florida Standards applicable specifically to those physicians who prescribe controlled substances in the pain-management context. The Florida Standards, under the subheading “Medical Records,” state that “[t]he physician is required to keep
1. The medical history and physical examination, including history of drug abuse or dependence, as appropriate;
2. Diagnostic, therapeutic, and laboratory results;
3. Evaluations and consultations;
4. Treatment objectives;
5. Discussion of risks and benefits;
6. Treatments;
7. Medications (including date, type, dosage, and quantity prescribed);
8. Instructions and agreements; and
9. Periodic reviews.
The Florida Standards similarly emphasize the need for proper documentation in the patient evaluation context by specifying:
A complete
Furthermore, the Florida Standards require a written treatment plan that “should state objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function, and should indicate if any further diagnostic evaluations or other treatments are planned.”
Another standard adopted by the Florida Board, under the subheading “Informed Consent and Agreement for Treatment,” is the directive that
[t]he physician should discuss the risks and benefits of the use of controlled substances with the patient, persons designated by the patient, or with the patient's surrogate or guardian if the patient
1. Urine/serum medication levels screening when requested;
2. Number and frequency of all prescription refills; and
3. Reasons for which drug therapy may be discontinued (
The Florida Standards contain a further requirement to periodically review “the course of pain treatment and any new information about the etiology of the pain or the patient's state of health.”
Continuation or modification of therapy depends on the physician's evaluation of the patient's progress. If treatment goals are not being achieved, despite medication
Under the subheading “Consultation,” the Florida Board promulgated the instruction that
[t]he physician should be willing to refer the patient as necessary for additional evaluation and treatment in order to achieve treatment objectives. Special attention should be given to those pain patients who are at risk for misusing their medications and those whose living arrangements pose a risk for medication misuse or diversion. The management of pain in patients with a history of substance abuse or with a comorbid psychiatric disorder requires extra care, monitoring, and documentation, and may require consultation with or referral to an expert in the management of such patients.
It is abundantly clear from the plain language of the Florida Standards
In his brief, the Respondent's counsel has prepared and submitted a thoughtful and detailed review of the patient charts analyzed by Dr. Kennedy. Respt's Br. at 5-10. While counsel argues that the patient chart entries were satisfactory, the expert's opinion at the hearing remained unchanged. Unfortunately, counsel's analysis is the product of a lay evaluation of standards applicable to the nuanced and sophisticated science that is the practice of medicine. An example of the problem encountered here can be seen where counsel urges that the medication contract clause requiring patients to follow-up with their primary care physicians was somehow satisfied by the patient following up with the Respondent.
The Respondent, who was in a unique position to conclusively refute Dr. Kennedy's views and explain the format and nuances of the reviewed documentation, elected not to testify in this matter. At a DEA administrative hearing, it is permissible to draw an adverse inference from the silence of the Respondent, even in the face of a Fifth Amendment invocation.
In the Social Security context, where an Administrative Law Judge has received expert medical opinions on the issue of the claimant's ability to work and they are not repudiated in any respect by substantial evidence, an adverse decision should be set aside as based on “suspicion and speculation.”
Accordingly, after carefully balancing the admitted evidence, the evidence establishes, by a preponderance of the evidence, that the prescriptions the Respondent issued in Florida were not issued within “the usual course of [the Respondent's] professional practice.” 21 CFR 1306.04(a). Consideration of the evidence under the second and fourth factors support the COR revocation sought by the Government in this case.
To the extent that the Respondent's prescribing practices fell below the requisite standard in Florida, that conduct also impacts upon the Fifth statutory factor. Under Factor 5, the Deputy Administrator is authorized to consider “other conduct which may threaten the public health and safety.” 21 U.S.C. 823(f)(5). Although this factor authorizes consideration of a somewhat broader range of conduct reaching beyond those activities typically associated with a registrant's practice, an adverse finding under this factor requires some showing that the relevant conduct actually constituted a threat to public safety.
Although admittedly not argued in the Government's brief, nowhere is the application of this fifth public interest factor more crystallized on this evidence than it is regarding the handling of SM. Inasmuch as there is no question that multiple controlled substances were identified in the decedent's body at the moment of death that were prescribed by multiple physicians, it would be difficult-to-impossible to precisely discern whether there was a specific one that could be isolated as the sole cause of his demise. An analysis centered on which physician's name appeared on the vial that produced the ultimately fatal dose misses the point. Even if it were conclusively established that a medication that was legitimately prescribed in the usual course of a professional practice resulted in an adverse consequence—even death—that fact alone would not necessarily decide the issue here. The practice of medicine has not yet developed to a condition of such mathematical precision that it is free of adverse consequences resulting from good-faith efforts on the part of treating physicians. The real focus of this aspect of this decision is not to conclusively divine which medication ultimately was the most lethal, or even which practitioner authorized it, but to evaluate whether the Respondent's
The evidence establishes that the Respondent engaged in a course of practice wherein she prescribed controlled substances to patients irrespective of the patients' need for such medication and ignoring any and all red flags that could or did indicate likely paths of diversion. The testimony of Dr. Kennedy, the DEA regulations, and the Florida Standards make clear that physicians prescribing controlled substances do so under an obligation to monitor the process to minimize the risk of diversion. The patient charts reflect that the Respondent, contrary to her obligations as a DEA registrant, did not follow up in the face of multiple red flags. The Respondent's disregard of her obligations as a DEA registrant and Federal and State laws related to controlled substances militate in favor of revocation.
By ignoring her responsibilities to monitor the controlled substance prescriptions she was authorizing to minimize diversion, and by participating in an insufficiently documented and thoughtful process for the issuance of potentially dangerous controlled substances, the Respondent created a significant potential conduit for the unchecked diversion of controlled substances.
Agency precedent has consistently held that where, as here, the
Based on the foregoing, the evidence supports a finding that the Government has established that the Respondent has committed acts that are inconsistent with the public interest. A balancing of the statutory public interest factors supports the revocation of the Respondent's Certificate of Registration and a denial of her application to renew. The Respondent has not accepted responsibility for her actions, expressed remorse for her conduct at any level, or presented evidence that could reasonably support a finding that the Deputy Administrator should continue to entrust her with a Certificate of Registration.
Accordingly, the Respondent's Certificate of Registration should be
In accordance with Section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on October 16, 2009, applicable to workers of Masco Builder Cabinet Group including on-site leased workers from Reserves Network, Jackson, Ohio. The workers produce cabinets and cabinet frames. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers and former workers of Masco Builder Cabinet Group, Waverly, Ohio (TA-W-71,287A) and Seal Township, Ohio (TA-W-71,287B). The company reports that workers leased from Third Dimension were employed at the Waverly, Ohio and Seal Township, Ohio locations of Masco Builder Cabinet Group.
The Department has determined that these workers were sufficiently under the control of Masco Builder Cabinet Group to be considered leased workers.
Based on these findings, the Department is amending this certification to include workers leased from Third Dimension working on-site at the Waverly, Ohio and Seal Township, Ohio locations of Masco Builder Cabinet Group.
The amended notice applicable to TA-W-71,287A and TA-W-71,287B is hereby issued as follows:
All workers of Masco Builder Cabinet Group, including on-site leased workers from Reserves Network, Reliable Staffing, and Third Dimension, Waverly, Ohio (TA-W-71,287A) and Seal Township, Ohio (TA-W-71,287B), who became totally or partially separated from employment on or after June 11, 2008, through October 16, 2011, and all workers in the group threatened with total or partial separation from employment on the date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended.
In accordance with Section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on January 12, 2011, applicable to workers of Wellpoint, Inc.,
At the request of the State agency, the Department reviewed the certification for workers of the firm. New findings show that worker separations occurred during the relevant time period at the above mentioned locations of Wellpoint, Inc., Enterprise Provider Data Management Team. Each location operates in conjunction with the Indianapolis, Indiana location. All were part of the overall servicing operation and were impacted by the firm shifting health insurance transactional services to a foreign country.
Accordingly, the Department is amending this certification to include workers at the above mentioned locations of Wellpoint, Inc., Enterprise Provider Data Management Team. The intent of the Department's certification is to include all workers of the firm who were adversely affected by a shift of health insurance transactional services to a foreign country.
The amended notice applicable to TA-W-74,895 is hereby issued as follows:
All workers of Wellpoint, Inc., d/b/A Anthem Blue Cross & Blue Shield, Enterprise Provider Data Management Team, including on-site leased workers from Kelly Services and Jacobsen Group, Indianapolis, Indiana (TA-W-74,895), Wellpoint, Inc., d/b/a/Anthem Health Plans of Kentucky, Enterprise Provider Data Management Team, Louisville, Kentucky (TA-W-74,895A), Wellpoint, Inc., Enterprise Provider Data Management Team, Saint Louis, Missouri (TA-W-74,895B), Wellpoint, Inc., d/b/a Anthem, Enterprise Provider Data Management Team, (Pewaukee), Waukesha, Wisconsin (TA-W-74,895C), Wellpoint, Inc., d/b/a Anthem, Enterprise Provider Data Management Team, Richmond, Virginia (TA-W-74,895D), Wellpoint, Inc., d/b/a Anthem East, Enterprise Provider Data Management Team, North Haven, Connecticut (TA-W-74,895E), Wellpoint, Inc., d/b/a Blue Cross Blue Shield of Georgia, Enterprise Provider Data Management Team, Atlanta, Georgia (TA-W-74,895F), Wellpoint, Inc., d/b/a Blue Cross Blue Shield of Georgia, Enterprise Provider Data Management Team, Columbus, Georgia (TA-W-74,895G), Wellpoint, Inc., d/b/a Anthem East, Enterprise Provider Data Management Team, South Portland, Maine (TA-W-74,895H), Wellpoint, Inc., d/b/a Anthem East, Enterprise Provider Data Management Team, Manchester, New Hampshire (TA-W-74,895I) Wellpoint, Inc., d/b/a Empire Blue Cross, Enterprise Provider Data Management Team, Albany, New York (TA-W-74,895J) Wellpoint, Inc., d/b/a Empire Blue Cross and Blue Shield, Enterprise Provider Data Management Team, Brooklyn, New York (TA-W-74,895K) Wellpoint, Inc., d/b/a Anthem, Enterprise Provider Data Management Team, Mason, Ohio (TA-W-74,895L), who became totally or partially separated from employment on or after November 15, 2009, through January 12, 2013, and all workers in the group threatened with total or partial separation from employment on the date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended.
In accordance with section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on June 2, 2010, applicable to workers of Weyerhaeuser Company, Corporate Headquarters, including on-site leased workers from Volt Services, Adecco, and Manpower, Federal Way, Washington. The workers supply corporate and administrative services for the firm. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The company reports that workers leased from Tek Systems were employed on-site at the Federal Way, Washington location of Weyerhaeuser Company, Corporate Headquarters. The Department has determined that these workers were sufficiently under the control of Weyerhaeuser Company, Corporate Headquarters to be considered leased workers.
Based on these findings, the Department is amending this certification to include workers leased from Tek Systems working on-site at the Federal Way, Washington location of Weyerhaeuser Company, Corporate Headquarters.
The amended notice applicable to TA-W-73,303 is hereby issued as follows:
All workers of Weyerhaeuser Company, Corporate Headquarters, including on-site leased workers from Volt Services, Adecco, Manpower, Express Personnel, and Tek Systems, Federal Way, Washington, who became totally or partially separated from employment on or after January 7, 2009, through June 2, 2012, and all workers in the group threatened with total or partial separation from employment on the date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended.
In accordance with section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on October 7, 2010, applicable to workers of Mueller Steam Specialty, including on-site leased workers from Staffing Alliance, Two Hawk Employment Agency and Robert Half Accountemps, St. Pauls, North Carolina. The workers produce strainers and valves. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm.
New information shows that workers separated from employment at the St. Pauls, North Carolina location of Mueller Steam Specialty had their wages reported through two separated unemployment insurance (UI) tax accounts under the names Core Industries and Watts Regulator, Watts Water Technologies.
Accordingly, the Department is amending this certification to properly reflex this matter.
The intent of the Department's certification is to include all workers the St. Pauls, North Carolina location of Mueller Steam Specialty, formerly known as Core Industries, including workers whose unemployment Insurance (UI) wages are reported through Watts Regulator, Watts Water Technologies who were adversely affected by increased imports of strainers and valves.
The amended notice applicable to TA-W-73,851 is hereby issued as follows:
All workers of Mueller Steam Specialty, formerly known as Core Industries, including workers whose unemployment insurance (UI) wages are reported through Watts regulator, Watts Water Technologies, including on-site leased workers from Staffing Alliance, Two Hawk Employment Agency and Robert Half Accountemps, St. Pauls, North Carolina, who became totally or partially separated from employment on or after April 5, 2009, through October 7, 2012, and all workers in the group threatened with total or partial separation from employment on date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended.
In accordance with Section 223 of the Trade Act of 1974, as amended (“Act”), 19 U.S.C. 2273, the Department of Labor issued a Certification of Eligibility to Apply for Worker Adjustment Assistance on January 27, 2010, applicable to workers of Assembly & Test Worldwide, Inc., Livonia, Michigan, Saginaw, Michigan, Lebanon, Missouri and Dayton, Ohio. The workers design, engineer, manufacture and integrate custom component assembly and test systems. The notice was published in the
At the request of the State agency, the Department reviewed the certification for workers of the subject firm. The company reports that as the result of a January 2011 acquisition, the Livonia, Michigan and Saginaw, Michigan locations of Assembly & Test Worldwide, Inc., are currently known as ATW Automation, Inc. Some workers separated from employment at the Livonia Michigan and Saginaw, Michigan locations of Assembly & Test Worldwide, Inc., had their wages reported under a separate unemployment insurance (UI) tax account under the name ATW Automation, Inc.
Accordingly, the Department is amending this certification to show that the Livonia, Michigan and Saginaw, Michigan locations of Assembly & Test Worldwide, Inc., are currently known as ATA Automation, Inc.
The intent of the Department's certification is to include all workers of the subject firm who were adversely affected by the shift in production of custom component assembly and test systems to Brazil, China and Germany.
The amended notice applicable to TA-W-72,075 is hereby issued as follows:
All workers of Assembly & Test Worldwide, Inc., currently known as ATW Automation, Inc., Livonia, Michigan (TA-W-72,075); Assembly & Test Worldwide, Inc., currently known as ATW Automation, Inc., Saginaw, Michigan (TA-W-72,075A); Assembly & Test Worldwide, Inc., Lebanon, Missouri (TA-W-72,075B); Assembly & Test Worldwide, Inc., Dayton, Ohio (TA-W-72,075C); Assembly & Test Worldwide, Lake Zurich, Illinois (TA-W-72,075D); and Assembly & Test Worldwide, Shelton, Connecticut (TA-W-72,075E), who became totally or partially separated from employment on or after August 10, 2008, through January 27, 2012, and all workers in the group threatened with total or partial separation from employment on date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended.
In accordance with Section 223 of the Trade Act of 1974, as amended (19 U.S.C. 2273) the Department of Labor herein presents summaries of determinations regarding eligibility to apply for trade adjustment assistance for workers by (TA-W) number issued during the period of
In order for an affirmative determination to be made for workers of a primary firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(a) of the Act must be met.
I. Under Section 222(a)(2)(A), the following must be satisfied:
(1) A significant number or proportion of the workers in such workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) The sales or production, or both, of such firm have decreased absolutely; and
(3) One of the following must be satisfied:
(A) Imports of articles or services like or directly competitive with articles produced or services supplied by such firm have increased;
(B) Imports of articles like or directly competitive with articles into which one or more component parts produced by such firm are directly incorporated, have increased;
(C) Imports of articles directly incorporating one or more component parts produced outside the United States that are like or directly competitive with imports of articles incorporating one or more component
(D) Imports of articles like or directly competitive with articles which are produced directly using services supplied by such firm, have increased; and
(4) The increase in imports contributed importantly to such workers' separation or threat of separation and to the decline in the sales or production of such firm; or
II. Section 222(a)(2)(B) all of the following must be satisfied:
(1) A significant number or proportion of the workers in such workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) One of the following must be satisfied:
(A) There has been a shift by the workers' firm to a foreign country in the production of articles or supply of services like or directly competitive with those produced/supplied by the workers' firm;
(B) There has been an acquisition from a foreign country by the workers' firm of articles/services that are like or directly competitive with those produced/supplied by the workers' firm; and
(3) The shift/acquisition contributed importantly to the workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected workers in public agencies and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(b) of the Act must be met.
(1) A significant number or proportion of the workers in the public agency have become totally or partially separated, or are threatened to become totally or partially separated;
(2) The public agency has acquired from a foreign country services like or directly competitive with services which are supplied by such agency; and
(3) The acquisition of services contributed importantly to such workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected secondary workers of a firm and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(c) of the Act must be met.
(1) A significant number or proportion of the workers in the workers' firm have become totally or partially separated, or are threatened to become totally or partially separated;
(2) The workers' firm is a Supplier or Downstream Producer to a firm that employed a group of workers who received a certification of eligibility under Section 222(a) of the Act, and such supply or production is related to the article or service that was the basis for such certification; and
(3) Either—
(A) The workers' firm is a supplier and the component parts it supplied to the firm described in paragraph (2) accounted for at least 20 percent of the production or sales of the workers' firm; or
(B) A loss of business by the workers' firm with the firm described in paragraph (2) contributed importantly to the workers' separation or threat of separation.
In order for an affirmative determination to be made for adversely affected workers in firms identified by the International Trade Commission and a certification issued regarding eligibility to apply for worker adjustment assistance, each of the group eligibility requirements of Section 222(f) of the Act must be met.
(1) The workers' firm is publicly identified by name by the International Trade Commission as a member of a domestic industry in an investigation resulting in—
(A) An affirmative determination of serious injury or threat thereof under section 202(b)(1);
(B) An affirmative determination of market disruption or threat thereof under section 421(b)(1); or
(C) An affirmative final determination of material injury or threat thereof under section 705(b)(1)(A) or 735(b)(1)(A) of the Tariff Act of 1930 (19 U.S.C. 1671d(b)(1)(A) and 1673d(b)(1)(A));
(2) The petition is filed during the 1-year period beginning on the date on which—
(A) A summary of the report submitted to the President by the International Trade Commission under section 202(f)(1) with respect to the affirmative determination described in paragraph (1)(A) is published in the
(B) Notice of an affirmative determination described in subparagraph (1) is published in the
(3) The workers have become totally or partially separated from the workers' firm within—
(A) The 1-year period described in paragraph (2); or
(B) Notwithstanding section 223(b)(1), the 1-year period preceding the 1-year period described in paragraph (2).
The following certifications have been issued. The date following the company name and location of each determination references the impact date for all workers of such determination.
The following certifications have been issued. The requirements of Section 222(a)(2)(A) (increased imports) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(a)(2)(B) (shift in production or services) of the Trade Act have been met.
The following certifications have been issued. The requirements of Section 222(c) (supplier to a firm whose workers are certified eligible to apply for TAA) of the Trade Act have been met.
In the following cases, the investigation revealed that the eligibility criteria for worker adjustment assistance have not been met for the reasons specified.
The investigation revealed that the criterion under paragraph (a)(1), or (b)(1), or (c)(1)(employment decline or threat of separation) of section 222 has not been met.
The investigation revealed that the criteria under paragraphs (a)(2)(A) (increased imports) and (a)(2)(B) (shift in production or services to a foreign country) of section 222 have not been met.
The investigation revealed that the criteria under paragraphs (b)(2) and (b)(3) (public agency acquisition of services from a foreign country) of section 222 have not been met.
After notice of the petitions was published in the
The following determinations terminating investigations were issued in cases where these petitions were not
The following determinations terminating investigations were issued because the petitioning groups of workers are covered by active certifications. Consequently, further investigation in these cases would serve no purpose since the petitioning group of workers cannot be covered by more than one certification at a time.
I hereby certify that the aforementioned determinations were issued during the period of
Petitions have been filed with the Secretary of Labor under section 221 (a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Division of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to section 221 (a) of the Act.
The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved.
The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing, provided such request is filed in writing with the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than April 18, 2011.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than April 18, 2011.
The petitions filed in this case are available for inspection at the Office of the Director, Office of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room N-5428, 200 Constitution Avenue, NW., Washington, DC 20210.
Petitions have been filed with the Secretary of Labor under section 221(a) of the Trade Act of 1974 (“the Act”) and are identified in the Appendix to this notice. Upon receipt of these petitions, the Director of the Division of Trade Adjustment Assistance, Employment and Training Administration, has instituted investigations pursuant to section 221(a) of the Act.
The purpose of each of the investigations is to determine whether the workers are eligible to apply for adjustment assistance under Title II, Chapter 2, of the Act. The investigations will further relate, as appropriate, to the determination of the date on which total or partial separations began or threatened to begin and the subdivision of the firm involved.
The petitioners or any other persons showing a substantial interest in the subject matter of the investigations may request a public hearing, provided such request is filed in writing with the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than April 18, 2011.
Interested persons are invited to submit written comments regarding the subject matter of the investigations to the Director, Office of Trade Adjustment Assistance, at the address shown below, not later than April 18, 2011.
The petitions filed in this case are available for inspection at the Office of the Director, Office of Trade Adjustment Assistance, Employment and Training Administration, U.S. Department of Labor, Room N-5428, 200 Constitution Avenue, NW., Washington, DC 20210.
On September 21, 2010, the Department of Labor issued an Affirmative Determination Regarding Application for Reconsideration for the workers and former workers of Consolidated Glass and Mirror Corporation, a Subsidiary of Guardian Industries Corporation, Galax, Virginia (subject firm). The Notice was published in the
Pursuant to 29 CFR 90.18(c), reconsideration may be granted under the following circumstances:
(1) If it appears on the basis of facts not previouslyconsidered that the determination complained ofwas erroneous;
(2) If it appears that the determination complained ofwas based on a mistake in the determination of factsnot previously considered; or
(3) If in the opinion of the Certifying Officer, a mis-interpretation of facts or of the law justifiedreconsideration of the decision.
The initial investigation resulted in a negative determination based on the findings that the subject firm did not, during the period under investigation, shift to/acquire from a foreign country the production of articles like or directly competitive with the mirrored and/or laminated glass products manufactured by the workers; that increased imports of articles like or directly competitive with the mirrored and/or laminated glass products manufactured by the workers did not contribute importantly to the workers' separation, or threat of separation; and that the workers did not produce a component part that was directly used in the production of an article or the supply of service by a firm that employed a worker group that is eligible to apply for Trade Adjustment Assistance (TAA) based on the aforementioned article.
The request for reconsideration, filed by former workers of the subject firm, stated that the Galax, Virginia facility is owned by “Guardian Industries, a
During the reconsideration investigation, the Department obtained from the subject firm additional information related to those customers identified in the request for reconsideration that both employed workers groups eligible to apply for TAA and conducted business with the subject firm during the relevant period.
Information obtained during the reconsideration investigation confirmed that, during the relevant period, the subject firm did not shift to/acquire from a foreign country import articles like or directly competitive with mirrored and/or laminated glass products manufactured by the subject workers. Further, the subject firm confirmed that, on a firm-wide basis, they do not import articles like or directly competitive with mirrored/laminated glass products nor did the subject firm import articles directly incorporating component parts produced outside the United States that are like or directly competitive with imports of articles incorporating one or more component parts produced by the subject firm.
While the subject firm may have produced and supplied a component part used by a firm that both employed a worker group that is currently eligible to apply for TAA and directly incorporated the glass products in the production of that article that was the basis for the TAA certification, information obtained during the reconsideration investigation revealed that the customer accounted for an insignificant percentage of the subject firm sales. Therefore, the Department confirms that the subject workers are not adversely affected secondary workers.
After reconsideration, I affirm the original notice of negative determination of eligibility to apply for worker adjustment assistance for workers and former workers of Consolidated Glass and Mirror Corporation, a Subsidiary of Guardian Industries Corporation, Galax, Virginia.
On September 21, 2010, the Department of Labor issued an Affirmative Determination Regarding Application for Reconsideration for the workers and former workers of Chrysler Financial Services Americas, LLC, a subsidiary of FinCo Intermediate Holding Co., LLC, Troy Customer Contact Center, Troy, Michigan (subject firm). The Department's Notice was published in the
The subject worker group is engaged in employment related to the supply of automotive-related financial services to dealers and consumers, including retail and wholesale financing, remarketing, and customer service and collections.
Pursuant to 29 CFR 90.18(c), reconsideration may be granted under the following circumstances:
(1) If it appears on the basis of facts not previously considered that the determination complained of was erroneous;
(2) if it appears that the determination complained of was based on a mistake in the determination of facts not previously considered; or
(3) if in the opinion of the Certifying Officer, a mis-interpretation of facts or of the law justified reconsideration of the decision.
The initial investigation resulted in a negative determination based on the findings that there have not been increased imports of services like or directly competitive with the financial services supplied by the subject firm, and there has not been a shift in the supply of services by the firm to a foreign country. In addition, the subject firm is not a supplier or downstream producer to a firm that employed a worker group eligible to apply for Trade Adjustment Assistance (TAA). For worker groups that supply a service instead of producing a component part, the term “supplier” means a firm that supplies directly to another firm services used in the production of articles or in the supply of services, as the case may be, that were the basis for the certification of eligibility.
The request for reconsideration states that “the workers at Chrysler Financial Services, Troy, Michigan were engaged in activities that initiated the need to produce automotive vehicles and automotive vehicle parts * * * multiple production facilities within the Chrysler Group has lost production due to imports which resulted in the decrease in sales.”
Information collected during the initial investigation confirmed that another domestic entity would be the new financial arm for Chrysler, LLC, and that, as a result, certain functions performed by the subject workers have been realigned domestically.
During the reconsideration investigation, the Department received information that confirmed that the subject firm did not shift to nor acquire from a foreign country the supply of services like or directly competitive with the services supplied by the subject workers.
Further, the Department determined that the services supplied by the subject workers were not used in the production of an article. Rather, the financial services supplied by the subject worker group are post-production.
After reconsideration, I affirm the original notice of negative determination of eligibility to apply for worker adjustment assistance for workers and former workers of Chrysler Financial Services Americas, LLC, a subsidiary of FinCo Intermediate Holding Co., LLC, Troy Customer Contact Center, Troy, Michigan.
On October 7, 2010, the Department of Labor issued an Affirmative Determination Regarding Application for Reconsideration for the workers and former workers of Columbia Forest Products, Inc., Presque Isle Division, Presque Isle, Maine (subject firm). The Department's Notice of determination was published in the
A careful review of the previously-submitted customer surveys and new information obtained during the reconsideration investigation, including U.S. aggregate imports of like or directly competitive articles and other available material, revealed that, during the period of investigation, imports of articles like or directly competitive with hardwood veneer produced by the subject firm have increased, and that the increased imports of hardwood veneer (or like or directly competitive articles) contributed importantly to the worker group separations and sales/production declines at the subject firm.
After careful review of the additional facts obtained during the reconsideration investigation, I determine that workers of Columbia Forest Products, Inc., Presque Isle Division, Presque Isle, Maine, who are engaged in employment related to the production of hardwood veneer, meet the worker group certification criteria under Section 222(a) of the Act, 19 U.S.C. 2272(a). In accordance with Section 223 of the Act, 19 U.S.C. 2273, I make the following certification:
All workers of Columbia Forest Products, Inc., Presque Isle Division, Presque Isle, Maine, who became totally or partially separated from employment on or after May 18, 2008, through two years from the date of this revised certification, and all workers in the group threatened with total or partial separation from employment on date of certification through two years from the date of certification, are eligible to apply for adjustment assistance under Chapter 2 of Title II of the Trade Act of 1974, as amended.
National Endowment for the Humanities.
Notice.
The National Endowment for the Humanities (NEH) has submitted the following public information collection request (ICR) to the Office of Management and Budget (OMB) for review and approval as required by the provisions of the Paperwork Reduction Act of 1995 (Pub. L. 104-13, 44 U.S.C. chapter 35). Copies of this ICR, with applicable supporting documentation, may be obtained by calling Susan G. Daisey, Director, Office of Grant Management, the National Endowment for the Humanities (202-606-8494) or may be requested by e-mail to
The Office of Management and Budget (OMB) is particularly interested in comments which: (1) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (2) Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) Minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology,
Ms. Susan G. Daisey, Director, Office of Grant Management, National Endowment for the Humanities, 1100 Pennsylvania Avenue, NW., Room 311, Washington, DC 20506, or by e-mail to:
National Science Foundation.
Notice and request for comments.
The National Science Foundation (NSF) is announcing plans to request clearance of this collection. In accordance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13), we are providing an opportunity for public comment on this action. After obtaining and considering public comment, NSF will prepare the submission requesting that OMB approve clearance of this collection for no longer than 3 years.
Written comments on this notice must be received by June 6, 2011 to be assured of consideration. Comments received after that date will be considered to the extent practicable.
Written comments regarding the information collection and requests for copies of the proposed information collection request should be addressed to Suzanne Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Blvd., Rm. 295, Arlington, VA 22230, or by e-mail to
Contact Suzanne H. Plimpton, Reports Clearance Officer, National Science Foundation, 4201 Wilson Boulevard, Suite 295, Arlington, Virginia 22230; telephone (703) 292-7556; or send e-mail to
The Advanced Study Institutes (ASI) travel awards are offered to advanced graduate students, to attend one of the NATO's ASIs held in the NATO-member and partner countries of Europe. The NATO ASI program is targeted to those individuals nearing the completion of their doctoral studies in science, technology, engineering and mathematics (STEM) who can take advantage of opportunities to become familiar with progress in their respective fields of specialization in other countries.
The Division of Graduate Education (DGE) in the Education and Human Resources (EHR) Directorate administers the NATO ASI Travel Awards Program. The following describes the procedures for the administration of the Foundation's NATO Advanced Study Institute (ASI) Travel Awards, which provide travel support for a number of U.S. graduate students to attend the ASIs scheduled for Europe.
Once NATO has notified DGE that the schedule of institutes is final, and DGE has received the descriptions of each institute, DGE determines which institutes NSF will support. The ASI travel award program supports those institutes that offer instruction in the STEM fields traditionally supported by NSF as published in
Following the final determination as to which Advanced Study Institutes NSF will support, DGE contacts each institute director to ask for a list of up to 5 nominations to be considered for NSF travel support.
Each individual who is nominated by a director will be sent the rules of eligibility, information about the amount of funding available, and the forms (NSF Form 1379, giving our Division of Financial Management (DFM) electronic banking information; NSF Form 1310 (already cleared), and NSF Form 192 (Application for International Travel Grant)) necessary for our application process.
Once an applicant has been selected to receive NSF travel award support, his or her application is sent to DFM for funding. DFM electronically transfers the amount of $1000 into the bank or other financial institution account identified by the awardee.
Our plan is to have the $1000 directly deposited into the awardee's account prior to the purchase of their airline ticket. An electronic message to the awardee states that NSF is providing support in the amount of $1000 for transportation and miscellaneous expenses. The letter also states that the award is subject to the conditions in F.L. 27,
As a follow-up, each ASI director may be asked to verify whether all NSF awardees attended the institute. If an awardee is identified as not utilizing the funds as prescribed, we contact the awardee to retrieve the funds. However, if our efforts are not successful, we will forward the awardee's name to the Division of Grants and Agreements (DGA), which has procedures to deal with that situation.
We also ask the awardee to submit a final report on an NSF Form 250, which we provide as an attachment to the electronic award message.
The criteria used to select NSF Advanced Study Institute travel awardees are as follows:
1. The applicant is an advanced graduate student.
2. We shall generally follow the order of the nominations, listed by the director of the institute, within priority level.
3. Those who have not attended an ASI in the past will have a higher priority than those who have.
4. Nominees from different institutions and research groups have higher priority than those from the same institution or research group. (Typically, no more than one person is invited from a school or from a research group.)
Exelon Generation Company, LLC (the licensee, Exelon) is the holder of Renewed Facility Operating License Nos. DPR-44 and DPR-56, which authorizes operation of the Peach Bottom Atomic Power Station (PBAPS), Units 2 and 3. The license provides, among other things, that the facility is subject to all rules, regulations, and orders of the Nuclear Regulatory Commission (NRC, the Commission) now or hereafter in effect.
The facility consists of two boiling-water reactors located partly in Peach Bottom Township, York County, partly in Drumore Township, Lancaster County, and partly in Fulton Township, Lancaster County, in southeastern Pennsylvania.
Title 10 of the
By letter dated March 6, 2009, “Request for Exemption from 10 CFR 50, Appendix R, Section III.G, `Fire Protection of Safe Shutdown Capability' ” available at Agencywide Documents Access and Management System (ADAMS), Accession No. ML090680141, and supplemented by letter dated February 12, 2010, “Response to Request for Additional Information Request for Exemption from 10 CFR 50, Appendix R, Section III.G, `Fire Protection of Safe Shutdown Capability' ” (ADAMS Accession No. ML100470774), the licensee requested an exemption for PBAPS, Units 2 and 3, from certain technical requirements of 10 CFR Part 50, Appendix R, Section III.G.2 (III.G.2) for the use of operator manual actions (OMAs) in lieu of meeting the circuit separation and protection requirements contained in III.G.2 for Fire Areas 2, 6N, 6S, 13N, 26, 30, 36, 37, 43, 50, and 58 at the plant.
Pursuant to 10 CFR 50.12, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR Part 50 when: (1) The exemptions are authorized by law, will not present an undue risk to public health or safety, and are consistent with the common defense and security; and (2) when special circumstances are present. The licensee has stated that special circumstances are present in that the application of the regulation in this particular circumstance is not necessary to achieve the underlying purpose of the rule, which is consistent with the language included in 10 CFR 50.12(a)(2)(ii).
In letters dated March 6, 2009, and February 12, 2010, the licensee discussed financial implications associated with plant modifications that may be necessary to comply with the regulation. 10 CFR 50.12(a)2(iii) states that if such costs have been shown to be significantly in excess of those contemplated at the time the regulation was adopted, or are significantly in excess of those incurred by others similarly situated, this may be considered a basis for considering an exemption request. However, financial implications were not considered in the regulatory review of the request since no substantiation was provided regarding such financial implications. Even though no financial substantiation was provided, the licensee did submit sufficient regulatory basis to support a technical review of the exemption request in that the application of the regulation in this particular circumstance is not necessary to achieve the underlying purpose of the rule.
In accordance with 10 CFR 50.48(b), nuclear power plants licensed before January 1, 1979, are required to meet Section III.G, of 10 CFR Part 50, Appendix R. The underlying purpose of Section III.G of 10 CFR Part 50, Appendix R, is to ensure that the ability to achieve and maintain safe shutdown is preserved following a fire event. The regulation intends for licensees to accomplish this by extending the concept of defense-in-depth to:
(1) Prevent fires from starting;
(2) Rapidly detect, control, and extinguish promptly those fires that do occur;
(3) Provide protection for structures, systems, and components important to safety, so that a fire that is not promptly extinguished by the fire suppression activities will not prevent the safe shutdown of the plant.
The stated purpose of 10 CFR Part 50, Appendix R, Section III.G.2 (III.G.2) is to ensure that one of the redundant trains necessary to achieve and maintain hot shutdown conditions remains free of fire damage in the event of a fire. III.G.2 requires one of the following means to ensure that a redundant train of safe shutdown cables and equipment is free of fire damage, where redundant trains are located in the same fire area outside of primary containment:
a. Separation of cables and equipment by a fire barrier having a 3-hour rating;
b. Separation of cables and equipment by a horizontal distance of more than 20 feet with no intervening combustibles or fire hazards and with fire detectors and an automatic fire suppression system installed in the fire area; or
c. Enclosure of cables and equipment of one redundant train in a fire barrier having a 1-hour rating and with fire detectors and an automatic fire suppression system installed in the fire area.
Exelon has requested an exemption from the requirements of III.G.2 for PBAPS, Units 2 and 3 to the extent that one of the redundant trains of systems necessary to achieve and maintain hot shutdown is not maintained free of fire damage in accordance with one of the required means, for a fire occurring in Fire Areas 2 (Radwaste Building), 6S (Unit 2 Reactor Building), 6N (Unit 2 Reactor Building, North side), 13N (Unit 3 Reactor Building), 26 (Unit 3 Motor-Generator (MG) Set Ventilation Equipment Room), 30 (Unit 3 B/D Battery Room), 36 (E42 Switchgear Room), 37 (E22 Switchgear Room), 43 (E-4 Emergency Diesel Generator Room), 50 (Turbine Building), and 58 (Unit 3 MG Set Room).
In its submittals, the licensee described elements of the FPP that provide justification that the concept of defense-in-depth that is in place in the above fire areas is consistent with that intended by the regulation. To accomplish this, the licensee utilizes various protective measures. Specifically, the licensee stated that the purpose of its request was to credit the use of OMAs, in conjunction with other defense-in-depth features, in lieu of the separation and protective measures required by III.G.2 for a fire in the fire areas stated above.
In its March 6, 2009, and February 12, 2010, letters, the licensee provided an analysis that described how fire prevention is addressed for each of the fire areas for which the OMAs may be required. Unless noted otherwise in Section 3.4 below, all of the fire areas included in this exemption have a combustible fuel load that is considered to be low with fuel sources consisting primarily of fire retardant cable insulation and limited floor-based combustibles. Unless noted otherwise, there are no high energy ignition sources located in the areas. The fire areas included in the exemption are not shop areas, so hot work activities are infrequent with administrative control programs (
PBAPS has been divided into fire areas, as described in the PBAPS FPP. Three-hour fire barriers are normally used to provide fire resistive separation between adjacent fire areas. In some cases, barriers with a fire resistance rating of less than 3 hours are credited, but exemptions have been approved or engineering evaluations performed in accordance with Generic Letter 86-10, “Implementation of Fire Protection Requirements,” to demonstrate that the barriers are sufficient for the hazard. Walls separating rooms and zones within fire areas are typically constructed of concrete. In addition to these boundaries, the licensee provided a hazard analysis that described how detection, control, and extinguishment of fire are addressed for each of the fire areas for which the OMAs may be required.
Unless noted otherwise below, fire areas are provided with ionization smoke detectors in various locations within a particular fire area. Although not installed in accordance with a recognized standard with regard to spacing, the detectors are located near equipment such that they are likely to adequately detect a fire. Upon detecting smoke, the detectors initiate an alarm in the Control Room enabling fire brigade response. The licensee stated that in most cases, no automatic fire suppression systems are provided in the areas included in this exemption but that fire suppression systems are installed in plant areas with significant fire hazards, such as lube oil. Suppression systems have also been installed in areas with 1-hour barrier walls and 1-hour rated electrical raceway encapsulation.
The automatic suppression systems are not credited in reducing fire exposure to redundant equipment unless they are indicated as being full-area or specifically described as being effective for redundant equipment. Equipment operators are trained fire brigade members and would likely identify and manually suppress or extinguish a fire using the portable fire extinguishers and manual hose stations located throughout the fire areas.
Each OMA included in this review consists of a sequence of tasks that occur in various fire areas. The OMAs are initiated upon confirmation of a fire in a particular fire area. The licensee stated that the postulated fire events that may require the use of the OMAs would include multiple failures of various components or equipment. In most cases, it is considered highly unlikely that the sequence of events required to necessitate the OMAs would fully evolve because of the fire prevention, fire protection, and physical separation features in place. However, in the event that the sequence does evolve, the OMAs are available to provide assurance that safe shutdown can be achieved.
This analysis postulates that OMAs may be needed to assure safe shutdown capability in addition to the traditional fire protection features described above. For each of the fire areas included in this exemption, the licensee evaluated the OMAs against the criteria of NUREG-1852, “Demonstrating the Feasibility and Reliability of Operator Manual Actions in Response to Fire,” October 2007, in the March 6, 2009, submittal. A Fire Hazards Analysis was provided for each of the OMAs in the licensee's February 12, 2010, supplement.
The licensee's analysis addresses factors such as environmental concerns, equipment functionality and accessibility, available indications, communications, portable equipment, personnel protection equipment, procedures and training, staffing and demonstrations.
In its March 6, 2009, submittal, and further supported by its February 12, 2010, supplement, the licensee stated that environmental considerations such as radiological concerns, emergency lighting, temperature and humidity conditions and smoke and toxic gases were evaluated and found to not represent a negative impact on the operators' abilities to complete the OMA. The licensee stated that the dose limits contained in 10 CFR Part 20 are never challenged at any point along the travel path of any of the OMAs included in this exemption.
The licensee confirmed that each of the OMA locations addressed by this exemption is provided with emergency lighting that illuminates both the location where the manual action is performed and the access route to the manual action location. Where travel is required to buildings outside of the power block, portable lights are staged in the fire safe shutdown equipment locker which is inventoried and maintained by performance of a periodic routine test. The emergency
The licensee also confirmed that temperature and humidity conditions will not challenge the operators performing the OMAs. Additionally, the licensee indicated that heat and smoke or gas generation from a fire will not impact the operator performing the OMAs. This is further supported by the fact that the locations of the postulated fire events are in different fire areas than the locations for where the actions are performed. In most cases, the initiating fire area and manual action location fire area are in separate buildings and have separate ventilation systems. Other than smoke, CO
The licensee stated that the equipment to be operated as part of the OMAs will be functional and maintained free of fire damage and will be accessible to the operators performing the action. Additionally, PBAPS maintains Transient Response Implementing Plan procedures and T-300 Fire Guides. T-300 Fire Guides provide the operators with specific instructions in the event of a fire in a specific fire area. The T-300 Fire Guides provide a list of the key protected instruments available for a fire in the fire area and list any “prompt” actions that are needed to restore an instrument for a fire in that area (
With regard to communications, the licensee stated that PBAPS has radios and phones available as part of the normal communications between the Control Room and the operators. Although the communication system is not specifically hardened for post-fire survivability, the radio and phone systems are robustly designed such that they will be available following most fire scenarios. In the event that the radio and phone systems are inoperable, face-to-face communication, and adequate time, is available to dispatch the safe shutdown operators from the Control Room to perform the tasks and return to the Control Room for reassignment when the task is complete. With the exception of Action H, none of the operator manual actions addressed by this exemption require immediate or concurrent coordination with the Control Room while performing the task.
The licensee stated that if any keys, tools or equipment are required to perform the OMAs, the T-300 Fire Guides provide instructions on where to find them and how to use them. In addition, the licensee stated that operators are provided with standard personal protective equipment (PPE) (
The licensee stated that the T-300 Fire Guides provide in-depth safe shutdown direction for fires in specific fire areas and that the procedures included in the guides include specific instructions on assessing plant indications and events as well as instructions on how to perform each of the OMAs. The procedures are then used to train the operators on the OMAs, which consist primarily of activities that are considered to be similar to those performed as part of typical work activity and are considered straightforward with minimal training demands. In addition, the licensee stated that licensed operators are trained biennially on the use of the T-300 Fire Guides using simulator scenarios that start with a fire in a specific fire area.
With regard to staffing, the licensee stated that PBAPS maintains a minimum of three operators on each shift to perform safe shutdown duties in the event of a fire, which may be comprised of equipment operators, reactor operators or senior reactor operators. Additionally, the licensee stated that PBAPS performed several demonstrations using what is considered to be the most challenging initiating fire area, the Turbine Building (Fire Area 50), because it encompasses both Unit 2 and Unit 3, includes an action that is a prompt action in other fire areas, and includes a number of OMAs to perform within the first 60 minutes.
The NRC staff has determined that the licensee's analysis demonstrates that, for the expected scenarios, the OMAs can be diagnosed and executed within the amount of time necessary to complete them. The licensee's analysis also demonstrates that various factors, as discussed above, have been considered to address uncertainties in estimating the time available. Therefore, the NRC staff finds that the OMAs included in this review are feasible because there is adequate time available for the operator to perform the required OMAs to achieve and maintain hot shutdown following a postulated fire event. The following table summarizes the “required” verses “allowable” times for each OMA. Where a diagnosis time has been identified, it is included as part of the required time for a particular action. Where an action has multiple times or contingencies associated with the “allowable” completion time, the lesser time is used. This approach is considered to represent a conservative approach to analyzing the timelines associated with each of the OMAs with regard to the feasibility and reliability of the actions included in this exemption. In some cases, the margin between the required time and allowable time is small. Specifically actions D, U, V, and X, have 20 percent or less margin. This limited margin is based on using the most limiting information from the licensee. For example, if the licensee postulated up to 30 minutes for diagnosis, the higher value of the required time range noted in the table below includes the time to complete the action plus the full 30 minutes.
Finally, these numbers should not be considered without the understanding that the manual actions are a fall back in the unlikely event that the fire protection defense-in-depth features are insufficient. In most cases, there is no credible fire scenario that would necessitate the performance of these OMAs. The licensee provided a discussion of the times and circumstances associated with each of the actions in its March 6, 2009, and February 12, 2010, correspondence.
The completion times noted in the table above provide reasonable assurance that the OMAs can reliably be performed under a wide range of conceivable conditions by different plant crews. This is because the completion time, in conjunction with the time margins associated with each action and other installed fire protection features, account for sources of uncertainty such as variations in fire and plant conditions, factors unable to be recreated in demonstrations and human-centered factors. Therefore, the NRC staff finds that the OMAs included in this review are reliable because there is adequate time available to account for uncertainties not only in estimates of the time available, but also in estimates of how long it takes to diagnose a fire and execute the OMAs (
For each of the fire areas included in this exemption, the postulated fire scenarios and pertinent details are summarized in Section 3.4 below.
The licensee stated that the floor-based combustibles include health physics cleaning supplies, such as mops, vacuums and other Class A combustibles as well as several steel carts containing new resins in paper or plastic bags. The total weight of the plastic bags is estimated to be less than 5 pounds and empty resin bags are immediately removed.
The licensee stated that Fire Area 2 has fire suppression systems installed within the fire area but not within the rooms containing redundant cables. The licensee has further stated that the detection systems in the rooms containing redundant cables are not code compliant in terms of overall spacing in the fire area. However, a smoke detector is located within 5 feet of redundant cable ZA2B1021A. There is also a smoke detector located within 15 feet of both cables ZD3A1806A and ZD3A1321A. The licensee also stated that the Radwaste Control Room is located directly adjacent to these three rooms and that it is normally occupied by an equipment operator. Because of this, it is likely that any fire would be quickly identified by an operator in the area. Additionally, the licensee stated that a fully trained onsite fire brigade is provided, which is dispatched via plant page in the event of a fire. The fire brigade is composed of plant operators that are separate from operators assigned safe shutdown duties and are instructed to provide information about a fire event over the operations radio to assist in mitigating the event. Fire Area 2 is provided with manual fire fighting equipment such as portable fire extinguishers and manual hose stations throughout the area.
The licensee stated that Fire Area 2 is a large fire area containing a number of rooms on several elevations and that spatial separation of redundant cables is provided as discussed below.
The licensee stated that the redundant cables located in Fire Area 2 (cables ZA2B1021A and ZD3B1321A or ZD3A1806A) are located a minimum of approximately 30 feet from each other and that no intervening combustibles are present between the two trains of cables. This physical separation with the available fire detection system will provide the site fire brigade an opportunity to extinguish the fire before redundant trains are damaged. The licensee also stated that the cables are located a minimum of approximately 9 feet above the floor and that they are enclosed in rigid conduit, such that transient fire exposures and self-ignited cable fires are unlikely to affect the circuits.
In the unlikely event that both trains of cable are lost due to a fire in Fire Area 2, an OMA (Action B) is available to restore or maintain the necessary function to the effected equipment (SU-25 Breaker). Action B directs an operator to transfer SU-25 breaker auxiliary equipment from the normal power source to its alternate power source, by operating manual transfer switch 00S306, which is located in the Unit 2 Startup Building. The Unit 2 Startup Building is located in the exterior yard area.
The potential need to perform this action is low since this action is only needed if two of three offsite power sources are unavailable, power to the 2SU transformer tap changer is lost, and the tap changer is in the wrong position. The licensee stated that offsite power is provided to each of the 4kV Class 1E switchgear by two of three redundant
The licensee stated that balance of plant (BOP) cables are routed through Fire Area 2, but that the routing of the cables was not part of the analysis. In the licensee's February 12, 2010, supplement, the licensee described the circumstances that would determine the availability of the safe shutdown equipment located in this area; namely the 2SU power source, which includes a transformer tap changer that is powered by BOP power. Since the BOP cable routing was not part of the analysis, the loss of BOP power was assumed for a fire in these three fire areas. The licensee's analysis also assumed that the transformer tap changer, which is powered by the BOP and responsible for maintaining power to the 4kV Bus, was not in the correct position. When the tap changer is not in the correct position, the voltage could vary resulting in actuation of the 4kV trip relays.
In the unlikely event that all of the conditions discussed above exist and fire damage occurs to the redundant cables, Action C can be utilized, which directs operators to pull the fuse blocks for the degraded voltage trip relays to ensure that the 4kV busses remain available. Action C is a “prompt” action, with an allowable completion time of 30 minutes or less, however, the licensee stated that its analysis assumed that the redundant cables were lost regardless of their location and that the tap changer was not in the correct position. The licensee stated that the loss of certain equipment in a fire area due to a fire will result in a Control Room alert. Off Normal procedure ON-114, “Actual Fire Reported in the Power Block, Diesel Generator Building, Emergency Pump, Inner Screen or Emergency Cooling Tower Structures,” is immediately entered upon confirmation of a fire condition. Procedure ON-114 directs immediate entry into the Fire Guide for the affected fire area. The licensee also stated that a note is provided in the applicable safe shutdown fire guide series (T-300 Fire Guides) providing guidance on how to determine whether the 2SU transformer tap changer has lost power using indications within the Control Room. Therefore, the Control Room will know immediately if this action is required and a generic diagnosis time is not necessary.
The licensee's T-300 Fire Guides also provide the following guidance to assist operators in evaluating a postulated event, “If 2SU is the only offsite power source available, and a loss of power to the 2SU Transformer Tap Change has occurred, then perform the manual action to remove the fuses.” Additionally, the 2SU transformer and associated auxiliaries are located in the yard area and would not be exposed by a fire in Fire Area 2. Lastly, the location of the OMA to remove the fuses in the 4kV Switchgear Rooms is in a separate fire area, with ventilation systems that are separate from Fire Area 2.
The licensee stated that this action would only be required if the conduit containing cable, which is located above the suspended ceiling with the only exposing combustible being a tray with fire retardant cables, is damaged by fire. There is a lack of ignition sources and a relatively short length (approximately 6 feet) of cable that passes through Fire Area 2. In addition, there is a smoke detector located within 5 feet of the conduit containing the cable, which would result in rapid plant notification of an exposure fire.
In the unlikely event that a fire in Fire Area 2 damages cable ZA2B1014A, normal power to the 2AD003 battery charger could be lost, which is needed to maintain long term DC power through the station batteries. A loss of ZA2B1014A would necessitate a manual action to transfer battery charger 2AD003 to an alternate power source within 60 minutes since the batteries can operate for 60 minutes prior to the initiation of recharging. The alternate power source is routed in separate fire areas, so a single fire cannot damage both the normal and alternate power feed. Action D is available to transfer the alternate power supply to the battery charger 2AD003. The action entails closing a breaker located in the E13 4kV Switchgear Room (Fire Area 33) and then operating a manual transfer switch located in the E32 4kV Switchgear Room (Fire Area 38), both of which are separate fire areas from Fire Area 2.
Given the limited amount of combustible materials and ignition sources, it is unlikely that a fire would occur and go undetected by the smoke detection system noted above or unsuppressed by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Actions B, C, and D are available to provide additional assurance that safe shutdown capability is maintained.
The licensee stated that conduits are routed primarily through a transient combustible-free zone where a permit and review are required prior to the placement of combustibles in this area.
The licensee stated that Fire Area 6S has ionization smoke detectors installed in the overhead area but that these smoke detectors do not have code compliant spacing due to ceiling height and beam pockets. However, there are three smoke detectors located above the general routing of the redundant cable conduits, which would be expected to activate in the event of a fire occurring in close proximity to the redundant cables. Additionally, the licensee stated that a fully trained onsite fire brigade is provided, which is dispatched via plant page in the event of a fire. The fire brigade is composed of plant operators that are separate from operators assigned safe shutdown duties and are instructed to provide information about a fire event over the operations radio to assist in mitigating the event.
The licensee stated that Room 403 in Fire Area 6S has a ceiling height of approximately 29' and an approximate floor area of 6,848 square feet, so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
The licensee stated that recent plant experience with faults and malfunctions in similar load centers has been that even when energetic failures have occurred, its damage has been contained within the breaker cubicle, with some heat and smoke damage to immediately adjacent cubicles. Therefore, it is considered unlikely that the cables routed above the load centers would be affected by a fault within the load centers since there is not a credible fire scenario that would be capable of damaging the cables within the conduits.
A fire in Fire Area 6S has the potential to damage cables ZA2B1014A, ZA2A1505A, and ZA2B1021A. The licensee stated that there are three 480V
The loss of these cables could result in a loss of the normal power supply to the 2AD003 battery charger, which is needed to maintain long term DC power through the station batteries. A loss of ZA2B1014A, ZA2A1505A, and ZA2B1021A would necessitate a manual action to transfer battery charger 2AD003 to an alternate power source within 60 minutes since the batteries can operate for 60 minutes prior to the initiation of recharging. The alternate power source is routed in separate fire areas, so a single fire cannot damage both the normal and alternate power feed. Action G is available to transfer the alternate power supply to the battery charger 2AD003. The action entails closing a breaker located in the E13 4kV Switchgear Room (Fire Area 33) and then operating a manual transfer switch located in the E32 4kV Switchgear Room (Fire Area 38), both of which are separate fire areas from Fire Area 6S.
Given the limited amount of combustible materials, ignition sources, and the large volume of the space, it is unlikely that a fire would occur and go undetected by the smoke detection system noted above or unsuppressed by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Action G is available to provide additional assurance that safe shutdown capability is maintained.
The licensee stated that the only floor-based combustibles in this area are trash cans and cables. Trash can lids are designed to provide self-extinguishing capability to the trash cans. Cables in the area are qualified to the Institute of Electrical and Electronics Engineers, Inc. Standard-383, “IEEE Standard For Qualifying Class 1E Electrical Cables And Field Splices for Nuclear Power Generating Stations” (IEEE 383), or equivalent.
The licensee stated that Fire Area 6N has a smoke detection system installed, but that the spacing is not in compliance with National Fire Protection Association Code 72, “National Fire Alarm and Signaling Code” (NFPA 72), due to deep beam pockets at the ceiling of this area. However, there is a smoke detector within the vicinity (approximately 25 feet) of each of the cases where cable ZA2Q1280B and a “B” residual heat removal (RHR) cable intersect, which would be expected to activate in the event of a fire in close proximity to the redundant equipment. There is also an automatic water curtain on the west side of the Unit 2 Reactor Building that separates Fire Area 6N from Fire Area 6S, thus reducing any anticipated exposure from Fire Area 6S. Additionally, the licensee stated that a fully trained onsite fire brigade is provided, which is dispatched via plant page in the event of a fire. The fire brigade is composed of plant operators that are separate from operators assigned safe shutdown duties and are instructed to provide information about a fire event over the operations radio to assist in mitigating the event.
The licensee stated that Fire Area 6N is the Unit 2 Reactor Building 135' elevation, north side, which is in a separate building from the Cable Spreading Room, Fire Area 25, which is the location of the OMA.
The licensee stated that the cables associated with “B” RHR are located in trays and in conduit and that cables for both “A” and “B” RHR trains cross within 2 feet of each other. However, there are no high energy ignition sources where cable ZA2Q1280B and a “B” RHR train cable cross and only a small amount of combustibles in the area overall. Therefore, it is unlikely that a single fire could damage both the “A” train RHR cable and “B” RHR cables and necessitate the use of Action H. Action H, which requires coordination with the control room, directs an operator to insert a plug-in test switch into Panel 20C032, located in the Cable Spreading Room (Fire Area 25), to bypass the reactor low pressure permissive for opening MO-2-025A.
In the unlikely event that a fire does damage the pressure permissive instrumentation circuit for opening MO-2-025A, operators will be aware of the condition, either by electronic indications in the Control Room, a smoke detection alarm annunciation in the Control Room, or physical observation by operators, and will initiate Action H, which is the only OMA required to achieve hot shutdown for a fire in Fire Area 6N. Therefore, the Control Room will know immediately if this action is required and a generic diagnosis time is not necessary.
A fire in Fire Area 6N has the potential to damage cable ZA2Q1280B. This cable is associated with the pressure permissive circuit needed to open valve MO-2-10-025A. This valve needs to open to permit injection of Low Pressure Core Injection (“A” train RHR) following depressurization. Fire Area 6N also contains a number of cables associated with the “B” train of RHR. Any number of “B” RHR train cables could be damaged as a result of a fire in Fire Area 6N, so the licensee's analysis assumed that the “B” RHR was considered to be unavailable for a fire in Fire Area 6N.
Given the limited amount of combustible materials and ignition sources, it is unlikely that a fire would occur and go unsuppressed by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Action H is available to provide additional assurance that safe shutdown capability is maintained.
The licensee stated that limited amounts of Class A combustible materials, including step-off pads, are present in this area. The three cables addressed in this area are routed such that they terminate at either a 480V load center or a motor control center (MCC) cabinet or both.
The licensee stated that both elevations containing redundant equipment within Fire Area 13N have smoke detection systems installed that produce an alarm in the Control Room, but that due to the room height and steel beams at the ceiling, the spacing of the smoke detectors on both elevations does not meet the spacing listed in NFPA 72. Although not entirely compliant with NFPA 72, this system is considered to provide adequate coverage to detect a fire and alert operators of a fire. Additionally, the licensee stated that a fully trained onsite fire brigade is provided, which is dispatched via plant
The licensee stated that the 135' elevation of Fire Area 13N has a ceiling height of approximately 29' and an approximate floor area of 4,033 square feet and the 165' elevation has a ceiling height of approximately 29' and an approximate floor area of 6,848 square feet, so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
The licensee stated that while it is possible that any one of the three redundant cables located in Fire Area 13N could potentially be damaged as a result of a fault or failure within its associated 480V load center or MCC, the impact of a fire on the ability to perform this action is low since Fire Area 13N is in a separate building with a separate ventilation system from the E43 4kV Switchgear Room and ample time is available to complete the action. However, the other installed fire protection features such as the smoke detection system, cable conduit, and fire brigade response would likely minimize the impact of a fire on the cables themselves.
A fire in Fire Area 13N has the potential to damage cables ZD3B1313A, ZD3A1806A, and ZD3B3983A. The loss of any of these cables could result in a loss of the normal power supply to the 3DD003 battery charger. A loss of ZD3B1313A, ZD3A1806A, or ZD3B3983A, would necessitate a manual action to transfer battery charger 3DD003 to an alternate power source to within 60 minutes since the batteries can operate for 60 minutes prior to the initiation of recharging. Battery charger 3DD003 can also be fed from an alternate power source, which is routed in separate fire areas, so a single fire cannot damage both the normal and alternate power feed. Action J is available to transfer the alternate power supply to the battery charger 3DD003. The action entails first closing a breaker and then operating a manual transfer switch. The breaker and manual transfer switch are located in the E43 4kV Switchgear Room (Fire Area 34).
Given the limited amount of combustible materials, ignition sources, and the large volume of the space, it is unlikely that a fire would occur and go undetected by the smoke detection system noted above or unsuppressed by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Action J is available to provide additional assurance that safe shutdown capability is maintained.
The licensee stated that the primary combustible material in Fire Area 26 is fire retardant cable insulation and that there are no in situ ignition sources in the vicinity of the cables.
The licensee stated that in Fire Area 26, there are two ionization smoke detectors located in the portion of the room containing the cables of concern, but that the overall detector placement for the fire area as a whole does not comply with the layout and spacing requirements of NFPA 72; however, the two smoke detectors are located in the immediate vicinity of the cables and would provide an alarm of a fire condition. Additionally, the licensee stated that a fully trained onsite fire brigade is provided, which is dispatched via plant page in the event of a fire. The fire brigade is composed of plant operators that are separate from operators assigned safe shutdown duties and are instructed to provide information about a fire event over the operations radio to assist in mitigating the event.
The licensee stated that Fire Area 26 has a ceiling height of approximately 25' and an approximate floor area of 2,100 square feet, so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
The licensee stated that it is unlikely that Action K will be necessary because there is reasonable assurance that both of the cables would not be damaged in the event of a fire in Fire Area 26 since there are no in situ ignition sources in Fire Area 26 in the vicinity of the cables, there are no combustible materials, other than fire retardant cable insulation exposing the two cables, and there are two smoke detectors provided in the area to notify operators of a fire. In the event that the action is necessary, the impact of a fire on the ability to perform this action is low since Fire Area 26N is in a separate building with a separate ventilation system from the E43 4kV Switchgear Room and ample time is available to complete the action.
A fire in Fire Area 26 has the potential to damage cables ZD3B1313A, ZD3A1806A, and ZD3B3983A. The loss of any of these cables could result in a loss of the normal power supply to the 3DD003 battery charger. A loss of ZD3B1313A, ZD3A1806A, or ZD3B3983A, would necessitate a manual action to transfer battery charger 3DD003 to an alternate power source within 60 minutes since the batteries can operate for 60 minutes prior to the initiation of recharging. Battery charger 3DD003 can also be fed from an alternate power source, which is routed in separate fire areas, so a single fire cannot damage both the normal and alternate power feed. Action K is available to transfer the alternate power supply to the battery charger 3DD003. The action entails first closing a breaker and then operating a manual transfer switch. The breaker and the manual transfer switch are located in the E43 4kV Switchgear Room (Fire Area 34).
Given the limited amount of combustible materials, ignition sources, and the large volume of the space, it is unlikely that a fire would occur and go undetected by the smoke detection system noted above or unsuppressed by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Action K is available to provide additional assurance that safe shutdown capability is maintained.
The licensee stated that the combustible loading in this area is considered to be low with the primary combustible material in this area being liquid filled plastic battery cases and that there are no cables in trays in this fire area. Additionally, the potential for hydrogen buildup due to the battery charging process is mitigated by the ventilation system in the room. The ventilation system is monitored, alarmed, and programmatically controlled. The licensee also stated that there are no significant ignition sources in this area.
The licensee stated that for Fire Area 30 there are three smoke detectors located in the room and that the spacing of the detectors is compliant with NFPA 72 with regard to ceiling height, beam configuration and air flow. Additionally, two of the three smoke detectors are located directly above the encapsulated conduits that contain redundant cables. Additionally, the licensee stated that a fully trained onsite fire brigade is provided, which is dispatched via plant page in the event of a fire. The fire brigade is composed of plant operators that are separate from operators assigned safe shutdown duties and are instructed to provide information about a fire event over the operations radio to assist in mitigating the event.
The licensee stated that Fire Area 30 has a ceiling height of approximately 14′ and an approximate floor area of 525 square feet, so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
The licensee stated that it is unlikely that both of the redundant cables located in Fire Area 30 would be damaged in the event of a fire in Fire Area 30 since the conduits containing cables ZA3B1014A and ZA3A1505A are both encapsulated in abandoned Thermo-Lag, the primary combustible material in the room is liquid filled plastic battery cases, there are no cable trays or high voltage components located in the fire area, there are three smoke detectors located in close proximity to the cables, and the potential for hydrogen release from the battery charging process is mitigated by the ventilation system that is monitored for operation and addressed by the Technical Requirements Manual.
A fire in Fire Area 30 has the potential to damage cables ZA3B1014A and ZA3A1505A, which the licensee stated are located approximately 16 inches from one another at their closest location. The loss of either of these cables could result in a loss of the normal power supply to the 3AD003 battery charger (located in Fire Area 32). A loss of ZA3B1014A or ZA3A1505A would necessitate a manual action to transfer battery charger 3AD003 to an alternate power source within 60 minutes since batteries can operate for 60 minutes prior to the initiation of recharging. Battery charger 3AD003 can also be fed from an alternate power source, which is routed in separate fire areas, so a single fire cannot damage both the normal and alternate power feed. Action M is available to transfer the alternate power supply to the battery charger 3AD003. The action entails operating a manual transfer switch located in the E33 4kV Switchgear Room (located in a different fire area).
Given the ventilation system located in the room, limited amount of combustible materials, lack of ignition sources, and the volume of the space, it is unlikely that a fire would occur and go undetected by the smoke detection system noted above or unsuppressed by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Action M is available to provide additional assurance that safe shutdown capability is maintained.
The licensee stated that the cables in this area are qualified to IEEE 383, or equivalent. The licensee also indicated that there are several sections of Thermo-Lag in the room. Thermo-Lag is a fire barrier material that is also considered a combustible. The licensee determined that this material does not create a credible fire exposure to the conduit and that the overall combustible material loading for the area is low. Additionally, Fire Area 36 contains 4kV switchgear which can create a high energy fault in the event of a failure and is considered an ignition source. However, the conduit containing the cables of concern is routed 4 feet horizontally from the front of the switchgear cabinet, not routed over the switchgear, and is not expected to be damaged in the event of a switchgear failure. Conduit containing four cables of concern is routed over two battery chargers, which convert 480 volt AC into 125 volt DC for the batteries. However, these chargers are not anticipated to provide a sustained fault current like a 4kV switchgear, but heat from a failure could expose the conduit and, therefore, represent an ignition source.
The licensee stated that Fire Area 36 has an NFPA 72-compliant smoke detection system installed, comprised of six smoke detectors, and that the room is also provided with a pre-action sprinkler system designed in accordance with NFPA Standard 13, “Standard for the Installation of Sprinkler Systems” (NFPA 13). Additionally, the licensee stated that a fully trained onsite fire brigade is provided, which is dispatched via plant page in the event of a fire. The fire brigade is composed of plant operators that are separate from operators assigned safe shutdown duties and are instructed to provide information about a fire event over the operations radio to assist in mitigating the event.
The licensee stated that Fire Area 36 has a ceiling height of approximately 14′ and an approximate floor area of 525 square feet, so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
The licensee stated that while it is possible that the redundant cables located in Fire Area 36 could potentially be damaged by heat resulting from a battery charger failure, it is unlikely that the cables within the conduits would be damaged since Fire Area 36 has full area smoke detection and pre-action sprinkler systems, the conduit is not routed directly above the 4kV switchgear, the combustible loading in the room is low consisting primarily of fire retardant cable insulation and Thermo-Lag, and there are no cable trays routed below the conduit.
A fire in Fire Area 36 has the potential to damage cables ZA2A1501E, ZA2A1501F, ZA2A1508E, and ZA2A1508F, which the licensee stated are routed together in a single conduit, located approximately 9 feet above the floor, for their entire length in Fire Area 36. The loss of these cables could result in the loss of power to the E12 bus from the E1 Emergency Diesel Generator. Since Fire Area 36 is the E42 4kV Switchgear Room, the switchgear in this room is primarily associated with the B and D electrical trains. Therefore, a fire in this room is assumed to result in the loss of the components associated with the B and D trains. In the event that these are lost due to a fire in Fire Area 36, Action R is available, which directs an operator to enter the E12 Switchgear Room (located in Fire Area 39) and pull two fuse blocks, open two breakers by depressing the mechanical breaker trip button and taking a Main Control Room breaker control switch to “Close.”
Given the limited amount of combustible materials and the volume of the space, it is unlikely that a fire would occur and go undetected by the smoke detection system noted above or unsuppressed by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Action R is available to provide additional assurance that safe shutdown capability is maintained.
The licensee stated that the cables in this area are qualified to IEEE 383, or equivalent. Thermo-Lag is also present, but does not create a credible fire exposure to the conduit. The licensee determined that this material does not create a credible fire exposure to the conduit and that the overall combustible material loading for the area is low. Fire Area 37 also contains 4kV switchgear which can create a high energy fault in the event of a failure and is considered an ignition source. However, the conduit containing the cables of concern is routed 4 feet horizontally from the front of the switchgear cabinet, not routed over the switchgear, and is not expected to be damaged in the event of a switchgear failure. Additionally, a bank of 480V MCCs exposes conduit containing four cables of concern to an exposure hazard in the event that an MCC fails.
The licensee stated that Fire Area 37 has an NFPA 72-compliant smoke detection system installed, comprised of three smoke detectors, and that the room is also provided with a pre-action sprinkler system designed in accordance with NFPA 13. Additionally, the licensee stated that a fully trained onsite fire brigade is provided, which is dispatched via plant page in the event of a fire. The fire brigade is composed of plant operators that are separate from operators assigned safe shutdown duties and are instructed to provide information about a fire event over the operations radio to assist in mitigating the event.
The licensee stated that Fire Area 37 has a ceiling height of approximately 14' and an approximate floor area of 525 square feet, so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
The licensee stated that while it is possible that the redundant cables located in Fire Area 37 could potentially be damaged by failure of the bank of 480V MCCs located below the conduit, it is unlikely that the cables within the conduits would be damaged since Fire Area 37 has full area smoke detection and pre-action sprinkler systems, the conduit is not routed directly above the 4kV switchgear, the combustible loading in the room is low consisting primarily of fire retardant cable insulation and Thermo-Lag, and there are no cable trays routed below the conduit.
A fire in Fire Area 37 has the potential to damage cables ZA2A1501E, ZA2A1501F, ZA2A1508E, and ZA2A1508F, which the licensee stated are routed together in a single conduit, located approximately 9 feet above the floor, for their entire length in Fire Area 37. The loss of these cables could result in the loss of power to the E12 bus from the E1 Emergency Diesel Generator. Since Fire Area 37 is the E22 4kV Switchgear Room, the switchgear in this room is primarily associated with the B and D electrical trains, so a fire in this room is assumed to result in the loss of the components associated with the B and D trains. In the event that these are lost due to a fire in Fire Area 36, Action R is available, which directs an operator to enter the E12 Switchgear Room (located in Fire Area 39) and pull two fuse blocks, open two breakers by depressing the mechanical breaker trip button and taking a Main Control Room breaker control switch to “Close.”
Given the limited amount of combustible materials and the volume of the space, it is unlikely that a fire would occur and go undetected by the smoke detection system noted above or unsuppressed by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Action S is available to provide additional assurance that safe shutdown capability is maintained.
The licensee stated that other than the diesel fuel and lube oil in the EDG Rooms, the combustible material loading is considered to be low. The fuel oil day tank is located within the fire area, but in a separate room with heavy concrete walls and a 3-hour Underwriters Laboratory (UL)-listed fire door. Additionally, failure of an operating diesel generator represents a significant ignition source. There are also high voltage electrical components associated with the generator in the room. However, these ignition sources are only credible when the diesel is in operation. During routine diesel operations, an equipment operator is stationed in the room to monitor the diesel and would be available to immediately suppress any small fires that occurred, or to secure the diesel if a significant malfunction occurred.
The licensee stated that Fire Area 43 has eight heat detectors installed that annunciate an alarm in the Control Room and that the room also has a manually-actuated carbon dioxide (CO
The licensee stated that the emergency diesel generator rooms are located in a separate building from the rest of the plant and that each of the emergency diesel generators are separated from one another with a three-hour rated fire barrier. Additionally, the OMA for this area is performed in the E42 Switchgear room, Fire Area 36, which is located in the turbine building.
The licensee stated that while it is possible that the redundant cables in Fire Area 43 could potentially be damaged by a lube or fuel oil fire, it is unlikely that the cables within the conduits would be damaged since they are located in conduit that is embedded in the floor slab for much of the length they are in Fire Area 43, and there would have to be a sufficient amount of oil present on the floor which then spreads across the floor to expose the control panels. Even if these two circumstances occur, a manually-actuated CO
A fire in Fire Area 43 has the potential to damage cables ZD2A1807E or ZD2A1807H, which the licensee stated are located in conduits embedded in the concrete floor slab, control
Given the limited amount of combustible materials and monitoring of credible ignition sources in this area, it is unlikely that a fire would occur and go undetected by the heat detection system or unsuppressed by the suppression system noted above or by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Action T is available to provide additional assurance that safe shutdown capability is maintained.
The licensee stated that limited amounts of Thermo-Lag and various Class A combustible materials are present in the fire area. The licensee also stated that the room containing the cables of concern contains two rows of 13kV switchgear cabinets, which would be capable of exposing the cables in the event of a 13 kV switchgear failure.
The licensee stated that Fire Area 50 includes most of the Unit 2 and Unit 3 Turbine Building and as such is a large fire area including several rooms located on multiple elevations. However, the cables of concern with regard to the associated OMA are only routed through Room 126. This room contains a full room smoke detection system with spacing in accordance with NFPA 72. In addition, a full room pre-action sprinkler system is provided in Room 126 with sprinkler head placement in accordance with NFPA 13. There is also an automatic sprinkler system in the adjacent open areas of the Turbine Building. The remainder of the Turbine Building is separated from Room 126 by heavy concrete radiation barriers and a water curtain (which is part of the Room 126 pre-action system) at the doorways. Additionally, the licensee stated that a fully trained onsite fire brigade is provided, which is dispatched via plant page in the event of a fire. The fire brigade is composed of plant operators that are separate from operators assigned safe shutdown duties and are instructed to provide information about a fire event over the operations radio to assist in mitigating the event.
The primary basis for preserving safe shutdown capability is included in the discussion of prevention, detection, suppression, and control above or included in the OMAs discussed below.
The licensee stated that while it is possible that one of the redundant cables located in Fire Area 50 could potentially be damaged by failure of the 13kV switchgear, it is unlikely that additional redundant cables would be damaged since the conduit containing cable ZD2A1807E runs above the 13kV switchgear, there is approximately 5 feet of separation between it and the next closest conduit which contains cable ZA2A1503E, and this conduit is not located above the 13kV switchgear. The area is also provided with a smoke detection system and a pre-action sprinkler system and the presence of abandoned, but intact, Thermo-Lag to protect the cables that are needed to ensure power to the “A” and “C” train switchgear to power credited shutdown components.
There is a cable associated with each of the four 4kV busses routed through Fire Area 50. There is the potential for any of the four diesel generator output breakers to spuriously close, rendering the bus unavailable until the diesel generator breaker is opened and lockouts are reset. The four cables associated with the Unit 2 4kV busses are: Bus E12 breaker cable ZA2A1503E; bus E22 breaker cable ZB2A1606E; bus E32 breaker ZC2A1704E; and bus E42 breaker cable ZD2A1807E. Loss of any one of these cables will only affect the associated 4kV bus and all four cables are routed in separate conduits. Cables ZA2A2503E and ZC2A1704E are routed in conduits that remain encapsulated in abandoned Thermo-Lag for their entire routing through Fire Area 50 while cables ZB2A1606E and ZD2A1807E are routed in conduit that is not encapsulated. The conduit containing cable ZB2A1606E is located within 5 feet of the conduits containing cables ZA2B1503E and ZD2A1807E.
Only cables ZA2A1503E and ZC2A1704E are necessary to power the busses credited for safe shutdown. However, Action U would restore power to all four busses. Only three of the four busses would require restoration within 60 minutes and only one bus is assumed to require restoration, since only one bus is assumed to spuriously operate. Nevertheless, a 26-minute performance time is credited for restoration of all four Unit 2 busses.
In the unlikely event that a fire does occur and goes undetected by the smoke detection system or unsuppressed by the suppression system and damages multiple redundant cables, Action U is available to restore power to the busses, which entails tripping the breaker and pulling a fuse block for each of the busses. The location of Action U is in the associated Switchgear Room for each associated bus. Additionally, the Switchgear Rooms are separate fire areas from the Turbine Building and from each other and have separate ventilation systems from the Turbine Building. Therefore, a fire in Fire Area 50 would not impact the location of the action.
Action V is the same as Action U above but for Unit 3. There is a cable associated with each of the four 4kV busses routed through Fire Area 50. There is the potential for any of the four diesel generator output breakers to spuriously close, rendering the bus unavailable until the diesel generator breaker is opened and lockouts are reset. The four cables associated with the Unit 3 4kV busses are: bus E13 breaker cable ZA3A1503E; bus E23 breaker cable ZB3A1606E; bus E33 breaker cable ZC3A1704E; and bus E43 breaker cable ZD3A1807E. Loss of any one of these cables will only affect the associated 4kV bus and all four cables are routed in separate conduits. Cables ZA3A1503E and ZC3A1704E are routed in conduits that remain encapsulated in abandoned Thermo-Lag for their entire routing through Fire Area 50 while cables ZB3A1606E and ZD3A1807E are routed in conduit that is not encapsulated. The conduit containing cable ZB3A1606E is located within 5 feet of the conduits containing cables ZA3A1503E and ZC3A1704E.
Only cables ZA3A1503E and ZC3A1704E are necessary to power the busses credited for safe shutdown. However, Action V would restore power
In the unlikely event that a fire does occur and goes undetected by the smoke detection system or unsuppressed by the suppression system and damages multiple redundant cables, Action V is available to restore power to the busses, which entails tripping the breaker and pulling a fuse block for each of the busses. The location of Action U is in the associated Switchgear Room for each associated bus. Additionally, the Switchgear Rooms are separate fire areas from the Turbine Building and from each other and have separate ventilation systems from the Turbine Building. Therefore, a fire in Fire Area 50 would not impact the location of the action.
The potential need to perform this action is low since this action is only needed if two of three other offsite power sources are unavailable, power to the 2SU transformer tap changer is lost, and the tap changer is in the wrong position. The licensee stated that offsite power is provided to each of the 4kV Class 1E switchgear by two of three redundant sources (2SU, 3SU, and 343SU) and that control cables for the sources have been physically separated by rerouting selected cables, such that one of the redundant sources remains free of fire damage for fires in most plant areas. In particular, the licensee stated that cables associated with the 2SU source have been relocated out of the Turbine Building (Fire Area 50), and portions of the Radwaste Building (Fire Areas 2 and 58).
The licensee stated that BOP cables are routed through Fire Area 50 but that the routing of the cables was not part of its analysis. In its February 12, 2010, supplement, the licensee described the circumstances that would determine the availability of the safe shutdown equipment located in this area; namely the 2SU power source, which includes a transformer tap changer that is powered by BOP power. Since the BOP cable routing was not part of the analysis, the loss of BOP power was assumed for a fire in these three fire areas. The licensee's analysis also assumed that the transformer tap changer, which is powered by the BOP and responsible for maintaining power to the 4kV Bus 2SU, was not in the correct position. When the tap changer is not in the correct position, the voltage could vary resulting in 4kV trip relays actuating.
In the unlikely event that all of the conditions discussed above exist and fire damage occurs to the redundant cables, Action X can be utilized, which directs operators to pull the fuse blocks for the degraded voltage trip relays to ensure that the 4kV busses remain available.
The licensee's T-300 Fire Guides provide the following guidance to assist operators in evaluating a postulated event, “If 2SU is the only offsite power source available, and a loss of power to the 2SU Transformer Tap Change has occurred, then perform the manual action to remove the fuses.”
A note is also provided in the Fire Guide for this step providing guidance on how to determine if the 2SU transformer tap changer has lost power using indications within the Control Room. Therefore, the Control Room will know if this action is required. Additionally, the 2SU transformer and associated auxiliaries are located in the yard area and would not be exposed by a fire in Fire Area 50. Lastly, the location of the OMA to remove the fuses in the 4kV Switchgear Rooms is in a separate fire area, with separate ventilation systems, from Fire Area 50.
The licensee stated that while it is possible that the redundant cables in Fire Area 50 could potentially be damaged by a fire resulting from a 13kV switchgear failure, it is unlikely that both of the cables within the conduits would be damaged since the conduit containing cable ZA2B1021B remains encapsulated in Thermo-Lag for the entire length above the 13kV switchgear, the cable ZA2B1021B is not located within the same conduit as cables ZD3B1321B and ZD3B1321D. In addition, the area is provided with a smoke detection system, as well as a pre-action sprinkler system.
The licensee stated that the redundant cables located in Fire Area 50 (cables ZA2B1021B and ZD3B1321B or ZD3A1321D) are located approximately 5 feet from each other and that no intervening combustibles are present between the two trains of cables. Additionally, the conduit containing cable ZA2B1021B remains encapsulated in abandoned Thermo-Lag for the entire routing through Fire Area 50. The licensee also stated that the conduits containing the cables associated with this OMA are routed directly above (approximately 5 feet) the 13kV switchgear cabinets in the room and that the conduits are assumed to be located within the anticipated heat plume in the event of a 13kV switchgear failure.
In the unlikely event that a fire does occur and goes undetected by the smoke detection system or unsuppressed by the suppression system and both trains of cable are lost, an OMA (Action V) is available to restore or maintain the necessary function to the effected equipment (SU-25 Breaker). Action V directs an operator to transfer SU-25 breaker auxiliary equipment from the normal power source to its alternate power source, by operating manual transfer switch 00S306, which is located in the Unit 2 Startup Building, which is located in the exterior yard area.
Given the limited amount of combustible materials and the volume of the space, it is unlikely that a fire would occur and go undetected by the smoke detection system noted above or unsuppressed by the suppression systems noted above or by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Actions U, V, X, and Y are available to provide additional assurance that safe shutdown capability is maintained.
The licensee stated that the combustible loading in Fire Area 58 is considered to be moderate and consists primarily of lube oil from the MG set. Other combustible materials in the area include fire retardant cable insulation and Thermo-Lag. Additionally, the MG set and the MCCs located in the room represent ignition sources.
The licensee stated that Fire Area 58 has a pre-action sprinkler system
The licensee stated that Fire Area 58 has a ceiling height of approximately 29' and an approximate floor area of 3,525 square feet, so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
The licensee stated that while it is possible that the two redundant cables in Fire Area 58 associated with the normal power supply to the 3DD003 battery charger could potentially be damaged by a lube oil or MG set fire, it is unlikely that the cables within the conduits would be damaged since the conduit containing cable ZD3B3983A is not located above the MG set. In addition, there is a smoke detection system provided in the area, as well as a pre-action sprinkler system located above the MG set. In the unlikely event that both cables are lost, the location of the action is in a different fire area from Fire Area 58.
A fire in Fire Area 58 has the potential to damage cables ZD3A1806A and ZD3B3983A, which the licensee stated are located in conduits embedded in the concrete floor slab, control panels, and a junction box. The loss of either of these cables could result in a loss of the normal power supply to the 3DD003 battery charger. The battery charger is needed to maintain long term DC power through the station batteries. The batteries can operate for 60 minutes prior to the initiation of recharging. Battery charger 3DD003 can also be fed an alternate power source, which is routed in separate fire areas, so a single fire cannot damage both the normal and alternate power feed.
In the unlikely event that a fire does occur and goes undetected by the smoke detection system or unsuppressed by the suppression system and the cables are damaged, Action BB is available to transfer the alternate power supply to battery charger 3DD003. The action entails closing a breaker and then operating a manual transfer switch, both located in the E43 4kV Switchgear Room (Fire Area 34), which is a separate fire area from Fire Area 58.
The potential need to perform this action is low since this action is only needed if two of three other offsite power sources are unavailable, power to the 2SU transformer tap changer lost, and the tap changer is in the wrong position. The licensee stated that offsite power is provided to each of the 4kV Class 1E switchgear by two of three redundant sources (2SU, 3SU, and 343SU) and that control cables for the sources have been physically separated by rerouting selected cables, such that one of the redundant sources remains free of fire damage for fires in most plant areas. In particular, the licensee stated that cables associated with the 2SU source have been relocated out of the Turbine Building (Fire Area 50), and portions of the Radwaste Building (Fire Areas 2 and 58).
The licensee stated that BOP cables are routed through Fire Area 58 but that the routing of the cables was not part of its analysis. In its February 12, 2010, supplement, the licensee described the circumstances that would determine the availability of the safe shutdown equipment located in this area; namely the 2SU power source, which includes a transformer tap changer that is powered by BOP power. Since the BOP cable routing was not part of the analysis, the loss of BOP was assumed for a fire in these three fire areas. The licensee's analysis also assumed that the transformer tap changer, which is powered by the BOP and responsible for maintaining power to the 4kV Bus 2SU, was not in the correct position. When the tap changer is not in the correct position, the voltage could vary resulting in the actuation of the 4kV trip relays.
In the unlikely event that a fire does occur and goes undetected by the smoke detection system or unsuppressed by the suppression system and fire damage occurs to the redundant cables, Action CC can be utilized, which directs operators to pull the fuse blocks for the degraded voltage trip relays to ensure that the 4kV busses remain available.
Action CC is a “prompt” action, however, the licensee stated that its analysis assumed that the redundant cables were lost regardless of their location and that the tap changer was not in the correct position. The licensee also stated that a note is provided in the applicable T-300 Fire Guide providing guidance on how to determine whether the 2SU transformer tap changer has lost power using indications within the Control Room. Therefore, the Control Room will know immediately if this action is required and a generic diagnosis time is not necessary.
The licensee's T-300 Fire Guides also provide the following guidance to assist operators in evaluating a postulated event, “If 2SU is the only offsite power source available and a loss of power to the 2SU Transformer Tap Changer has occurred, then perform the manual action to remove the fuses.”
Additionally, the 2SU transformer and associated auxiliaries are located in the yard area and would not be exposed by a fire in Fire Area 58. Lastly, the location of the OMA to remove the fuses in the 4kV Switchgear Rooms is in a separate fire area, with separate ventilation systems, from Fire Area 58.
Given the moderate amount of combustible materials, ignition sources, and the large volume of the space, it is unlikely that a fire would occur and go undetected by the smoke detection system noted above or unsuppressed by the suppression system noted above or by personnel, and damage the safe shutdown equipment. Even if such circumstances exist, Actions BB and CC are available to provide additional assurance that safe shutdown capability is maintained.
In summary, the NRC staff finds that the defense-in-depth concept for a fire in the fire areas discussed above provides a level of safety that results in the unlikely occurrence of fires, rapid detection, control and extinguishment of fires that do occur and the protection of structures, systems and components important to safety. As discussed above, the licensee has provided preventative and protective measures in addition to
This exemption would allow PBAPS to rely on OMAs, in conjunction with the other installed fire protection features, to ensure that at least one means of achieving and maintaining hot shutdown remains available during and following a postulated fire event, as part of its FPP, in lieu of meeting the requirements specified in III.G.2 for a fire in the analyzed fire areas. As stated above, 10 CFR 50.12 allows the NRC to grant exemptions from the requirements of 10 CFR Part 50. The NRC staff has determined that granting of this exemption will not result in a violation of the Atomic Energy Act of 1954, as amended, or the Commission's regulations. Therefore, the exemption is authorized by law.
The underlying purpose of 10 CFR Part 50, Appendix R, Section III.G is to ensure that at least one means of achieving and maintaining hot shutdown remains available during and following a postulated fire event. Based on the above, no new accident precursors are created by the use of the specific OMAs, in conjunction with the other installed fire protection features, in response to a fire in the analyzed fire areas. Thus, the probability of postulated accidents is not increased. Also, based on the above, the consequences of postulated accidents are not increased. Therefore, there is no undue risk to public health and safety.
The proposed exemption would allow PBAPS to credit the use of the specific OMAs, in conjunction with the other installed fire protection features, in response to a fire in the analyzed fire areas, discussed above, in lieu of meeting the requirements specified in III.G.2. This change, to the operation of the plant, has no relation to security issues. Therefore, the common defense and security is not diminished by this exemption.
Pursuant to 10 CFR 50.12(a)(2)(ii) special circumstances are present whenever application of the regulation in the particular circumstances is not necessary to achieve the underlying purpose of the rule. The underlying purpose of 10 CFR Part 50, Appendix R, Section III.G is to ensure that at least one means of achieving and maintaining hot shutdown remains available during and following a postulated fire event. Therefore, since the underlying purpose of Appendix R, Section III.G is achieved, the special circumstances for granting an exemption from 10 CFR Part 50, Appendix R, Section III.G exist, as required by 10 CFR 50.12(a)(2)(ii).
Accordingly, the Commission has determined that, pursuant to 10 CFR 50.12(a), the exemption is authorized by law, will not present an undue risk to the public health and safety, and is consistent with the common defense and security. Also, special circumstances are present. Therefore, the Commission hereby grants Exelon an exemption from the requirements of Section III.G.2 of Appendix R of 10 CFR Part 50, to utilize the OMAs discussed above at PBAPS.
Pursuant to 10 CFR 51.32, the Commission has determined that the granting of this exemption will not have a significant effect on the quality of the human environment (75 FR 58445).
This exemption is effective upon issuance.
For The Nuclear Regulatory Commission.
Exelon Generation Company, LLC (Exelon or the licensee) is the holder of Facility Operating License No. DPR-16 that authorizes operation of the Oyster Creek Nuclear Generating Station (Oyster Creek). The license provides, among other things, that the facility is subject to all rules, regulations, and orders of the U.S. Nuclear Regulatory Commission (NRC or the Commission) now or hereafter in effect.
The facility consists of a boiling-water reactor located in Ocean County, New Jersey.
Title 10 of the
By letter dated March 4, 2009, “Request for Exemption from 10 CFR 50, Appendix R, Section III.G, `Fire Protection of Safe Shutdown Capability (Phase 2)' ” available at Agencywide Documents Access and Management System (ADAMS), Accession No. ML090640225, and supplemented by letter dated April 2, 2010, “Response to Request for Additional Information Request for Exemption from 10 CFR Part 50, Appendix R, Section III.G, `Fire Protection of Safe Shutdown Capability' ” (ADAMS Accession No. ML100920370), the licensee requested an exemption for Oyster Creek from certain technical requirements of 10 CFR Part 50, Appendix R, Section III.G.2 (III.G.2) for the use of operator manual actions (OMAs) in lieu of meeting the circuit separation and protection requirements contained in III.G.2 for the following 22 plant areas: CW-FA-14, OB-FA-9, OB-FZ-6A, OB-FZ-6B, OB-FZ-8A, OB-FZ-8B, OB-FZ-8C, OB-FZ-10A, RB-FZ-1D, RB-FZ-1E, RB-FZ-1F3, RB-FZ-1F5, RB-FZ-1G, TB-FA-3A, TB-FA-26, TB-FZ-11B, TB-FZ-11C, TB-FZ-11D, TB-FZ-11E, TB-FZ-11F, TB-FZ-11H, and Yard. The 22 plant areas noted above are the subject of this exemption.
Pursuant to 10 CFR 50.12, the Commission may, upon application by any interested person or upon its own initiative, grant exemptions from the requirements of 10 CFR Part 50 when: (1) The exemptions are authorized by law, will not present an undue risk to public health or safety, and are consistent with the common defense and security; and (2) when special circumstances are present. The licensee has stated that special circumstances are present in that the application of the regulation in this particular circumstance is not necessary to achieve the underlying purpose of the rule, which is consistent with the language included in 10 CFR 50.12(a)(2)(ii).
In their March 4, 2009, and April 2, 2010, letters, the licensee discussed financial implications associated with plant modifications that may be necessary to comply with the regulation.
Section 50.12(a)2(iii) of 10 CFR states that if such costs have been shown to be significantly in excess of those contemplated at the time the regulation was adopted, or are significantly in excess of those incurred by others similarly situated, this may be considered a basis for considering an exemption request. However, financial implications were not considered in the regulatory review of their request since no substantiation was provided regarding such financial implications. Even though no financial substantiation was provided, the licensee did submit sufficient regulatory basis to support a technical review of their exemption request in that the application of the regulation in this particular circumstance is not necessary to achieve the underlying purpose of the rule.
In accordance with 10 CFR 50.48(b), nuclear power plants licensed before January 1, 1979, are required to meet Section III.G of 10 CFR Part 50, Appendix R. The underlying purpose of Section III.G of 10 CFR Part 50, Appendix R, is to ensure that the ability to achieve and maintain safe shutdown is preserved following a fire event. The regulation intends for licensees to accomplish this by extending the concept of defense-in-depth to:
(1) Prevent fires from starting;
(2) Rapidly detect, control, and extinguish promptly those fires that do occur;
(3) Provide protection for structures, systems, and components important to safety so that a fire that is not promptly extinguished by the fire suppression activities will not prevent the safe shutdown of the plant.
The stated purpose of 10 CFR Part 50, Appendix R, Section III.G.2 (III.G.2) is to ensure that one of the redundant trains necessary to achieve and maintain hot shutdown conditions remains free of fire damage in the event of a fire. Section III.G.2 requires one of the following means to ensure that a redundant train of safe shutdown cables and equipment is free of fire damage, where redundant trains are located in the same fire area outside of primary containment:
a. Separation of cables and equipment by a fire barrier having a 3-hour rating;
b. Separation of cables and equipment by a horizontal distance of more than 20 feet with no intervening combustibles or fire hazards and with fire detectors and an automatic fire suppression system installed in the fire area; or
c. Enclosure of cables and equipment of one redundant train in a fire barrier having a 1-hour rating and with fire detectors and an automatic fire suppression system installed in the fire area.
Exelon has requested an exemption from the requirements of III.G.2 for Oyster Creek to the extent that redundant trains of systems necessary to achieve and maintain hot shutdown are not maintained free of fire damage in accordance with one of the required means prescribed in III.G.2.
Each OMA included in this review consists of a sequence of tasks that occur in various fire areas. The OMAs are initiated upon confirmation of a fire in a particular fire area. Table 1 lists, in the order of the fire area of fire origin, the OMAs included in this review.
In their submittals the licensee described elements of their fire protection program that provide their justification that the concept of defense-in-depth that is in place in the above fire areas is consistent with that intended by the regulation. To accomplish this, the licensee utilizes various protective measures to accomplish the concept of defense-in-depth. Specifically, the licensee stated that the purpose of their request was to credit the use of OMAs, in conjunction with other defense-in-depth features, in lieu of the separation and protective measures required by III.G.2 for a fire in the fire areas stated above.
In their April 2, 2010, letter the licensee provided an analysis that described how fire prevention is addressed for each of the fire areas for which the OMAs may be required. The licensee developed a Fire Hazards Analysis (FHA) for each fire area or zone identified in its exemption request. For each fire area or zone, the FHA describes the physical location and arrangement of equipment, combustible loading, ignition sources, fire protection features, and proximity of redundant safe shutdown equipment to in situ hazards and identifies deviations from fire protection codes and previously approved exemptions. In addition, for each fire area or zone, the licensee's response includes a tabulation of potential ignition sources as well as the equipment that may exhibit high energy arcing faults. For each fire area or zone, the FHA states that the fire protection configuration achieves a level of protection commensurate with that intended by III.G.2.
The 22 areas or zones identified in the request have administratively limited combustible fuel loading with fuel sources consisting primarily of cable insulation and limited floor based combustibles except areas OB-FZ-6A, OB-FZ-6B, and TB-FZ-11B, which contain quantities of transformer liquid or lubricating oil. Combustible fuel loading in most areas is classified as low by the licensee while Fire Areas OB-FZ-6A and OB-FZ-6B have been classified as having a moderate combustible fuel loading and TB-FZ-11B has been classified as having a high combustible fuel loading. In addition, the licensee has stated that they maintain a robust administrative program (e.g., hot work permits, fire watches for hot work, and supervisory controls) to limit and control transient combustible materials and ignition sources in the areas. The fire areas included in the exemption are not shop areas so hot work activities are infrequent and the administrative control programs are in place if hot work activities do occur.
The licensee also stated that 98% of the Oyster Creek cables are jacketed with Vulkene, which passes the horizontal flame test of the Underwriter's Laboratory, therefore reducing the likelihood of the cables themselves contributing to a fire hazard. Furthermore, the areas or zones are of noncombustible construction with typical utilities installed lighting, ventilation, etc., and 3-hour fire resistance-rated barriers normally used to provide fire resistive separation between adjacent fire areas. In some cases, barriers with a fire resistance rating of less than 3 hours are credited, but exemptions have been approved or the licensee has stated they have performed engineering evaluations in accordance with Generic Letter 86-10 to demonstrate that the barriers are sufficient for the hazard. Walls separating rooms and zones within fire areas are typically constructed of heavy concrete. This compartmentalization of the areas reduces the likelihood for fire events in a particular area to spread to or impact other adjacent areas.
Many fire areas included in this exemption have automatic detection systems installed, although the licensee indicated that not all systems are installed in accordance with a recognized standard with regard to spacing in all areas. In such cases, the licensee has stated that the detectors are located near equipment such that they are likely to detect a fire. Upon detecting smoke, the detectors initiate an alarm in the constantly staffed control room. In addition to the automatic suppression systems noted below, equipment operators are trained fire brigade members and may identify and manually suppress or extinguish a fire using the portable fire extinguishers and manual hose stations located throughout the fire areas if a fire is identified in its early stages of growth.
The licensee stated that the postulated fire events that may require the use of the OMAs would include multiple failures of various components or equipment. In most cases, it is considered unlikely that the sequence of events required to necessitate the OMAs would fully evolve because of the fire prevention, fire protection, and physical separation features in place. However, in the event that the sequence does evolve, the OMAs are available to provide assurance that safe shutdown can be achieved. For each of the fire areas included in this exemption, the postulated fire scenarios and pertinent details are summarized in Table 2 below.
Each of the fire areas or zones included in this exemption is analyzed below with regard to how the concept of defense-in-depth is achieved for each area or zone and the role of the OMAs in the overall level of safety provided for each area or zone.
The licensee stated that combustible loading is not tracked in this area since it is an outside area. The licensee also stated that the primary combustible materials in the area are transformer liquid and electrical motors; although the amount is not quantified since the area is open to the atmosphere with no walls or ceiling to contain the heat or smoke that may be produced during a fire event. Additionally, the main combustible in this area that could result in the need for the OMAs is Dow Corning 561 Silicon transformer liquid, which the licensee states has characteristics that minimize the likelihood of a fire involving the insulating liquid itself.
CW-FA-14 is not equipped with automatic fire detection or suppression systems but since it is an outdoor area with no walls or ceiling, it is not expected that such systems would enhance this element of defense-in-depth in this area since the area is open to the atmosphere with no walls or ceiling to contain the heat or smoke that may be produced during a fire event. However, the licensee stated that a security tower monitors this area continuously. Therefore, any fire of significance would likely be detected and responded to appropriately by the station fire brigade. Manual suppression is also provided by a fire hydrant and fire hose house located approximately 75 feet from the principal fire hazards.
Since Fire Area CW-FA-14 is an outdoor space with no walls or ceiling, smoke and heat would not accumulate within the fire area to cause damage to components remote to the initiating fire or obstruct operator actions.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the main steam isolation valves (MSIVs) will close, as well as multiple air-operated valves changing state. Additionally, reactor pressure vessel (RPV) level indication is also available for all fire areas or zones. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and open nature of the area, it is unlikely that a fire would occur and go undetected or unsuppressed by the personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee has classified the fire loading in this fire area as low. The licensee also stated that the major combustibles in the multiplexer (MUX) corridor, which is within OC-FA-9, are cable insulation and a wood ceiling on top of the MUX enclosure, which is within the MUX corridor.
The licensee stated that OB-FA-9 has a partial area coverage wet pipe sprinkler system installed. The licensee further stated that the area is not provided with a detection system but that there is an installed detection system in the main hallways and inside of the MUX corridor and that it is a high traffic area so a fire would likely be detected by personnel. The wet pipe sprinkler system, when actuated, will alarm in the control room to notify operators of a potential fire event. Extinguishment of a fire in the majority of this area will be accomplished by the plant fire brigade.
The licensee stated that OB-FA-9 has a ceiling height of approximately 10′-6″, and an approximate floor area of 513 square feet in the MUX corridor where the safe shutdown equipment is located so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the sprinkler system noted above, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is moderate and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the main combustibles in this area are cable insulation (approximately 81% of loading) and Dow Corning 561 Silicon transformer liquid (approximately 15% of loading). The transformer liquid has characteristics that minimize the likelihood of a fire involving the insulating liquid itself.
The licensee stated that OB-FZ-6A has an automatic smoke detection system, a total flooding automatic Halon 1301 System, and manual fire fighting capabilities (portable extinguishers and hose stations).
The licensee stated that OB-FA-6A has a ceiling height of approximately 10′-8″, and an approximate floor area of 1157 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and the volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection or Halon system noted above, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this zone, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is moderate and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the main combustibles in this area are cable insulation (approximately 28% of loading), Thermo-Lag (approximately 29% of loading) and Dow Corning 561 Silicon transformer liquid (approximately 31% of loading). The transformer liquid has characteristics that minimize the likelihood of a fire involving the insulating liquid itself.
The licensee stated that OB-FZ-6B has an automatic smoke detection system, a total flooding Halon 1301 System, and manual fire fighting capabilities (portable extinguishers and hose stations).
The licensee stated that OB-FA-6B has a ceiling height of approximately 10′-8″ and an approximate floor area of 679 square feet so it is unlikely that
In order for OMA #18 to be necessary, a loss of instrument air to the isolation condenser valve V-11-36 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #18 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-36 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #18 is available to provide makeup control air to the accumulator for V-11-36 for the isolation condenser makeup line due to the loss of instrument air. If OMA #18 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and the volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection or Halon system noted above, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMA #18 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
Fire Zones OB-FZ-8A and 8B are evaluated together for the combustible loading and fire safe shutdown analysis. The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that there are minimal combustibles in Fire Zone OB-FZ-8B. The major combustibles in Fire Zone OB-FZ-8A are lubricating oil (approximately 83% of loading) and cable insulation (approximately 13% of loading).
The licensee stated that OB-FZ-8A has a partial wet-pipe sprinkler system with a flow alarm that notifies the control room and that the area does not have a smoke detection system however, a duct smoke detector is located in the exhaust duct of fan EF-1-20. Since operation of the sprinkler system will alarm in the control room, prompt notification of and response by, the fire brigade for any required manual fire fighting activities is expected.
The licensee stated that OB-FZ-8A has a ceiling height of approximately 10′-10″ and an approximate floor area of 2128 square feet and OB-FZ-8B has a ceiling height of approximately 11′-0″ and an approximate floor area of 479 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17
Given the limited amount of combustible materials, ignition sources, and the large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection or sprinkler systems noted above, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment in this zone, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the major combustibles in Fire Zone OB-FZ-8C are electrolyte-filled plastic battery cases and racks (approximately 56% of loading) and cable insulation (approximately 39% of loading).
The licensee stated that OB-FZ-8C has a fixed, total-flooding, Halon 1301 extinguishing system, area-wide smoke detection that is installed at the ceiling level and cross-zoned to sound a local alarm, and an alarm in the control room upon actuation of one detector. Actuation of a second detector will sound a local alarm, discharge the Halon system, trip supply and exhaust fans, and close dampers.
The licensee stated that OB-FZ-8C has a ceiling height of approximately 11′-0″ and an approximate floor area of 1292 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and the large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection or Halon systems noted above, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this zone, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the major combustibles in this area are cable insulation (approximate 27% of loading), rubber flooring (approximately 31% of loading), miscellaneous plastics (approximately 17% of loading) and protective clothing supplies (approximately 20% of loading). However, since the protective clothing have been placed in metal cans with self-closing lids they are no longer considered a contribution to the combustibles in this area.
The licensee stated that OB-FZ-10A has an area-wide smoke detection system and a wet-pipe automatic sprinkler system installed throughout the area. In addition, a hose station located nearby, outside the control room, provides manual suppression capability.
The licensee stated that OB-FZ-10A has a ceiling height of approximately 13′-0″ and an approximate floor area of 2019 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #18 to be necessary, a loss of instrument air to the isolation condenser valve V-11-36 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #18 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-36 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #18 is available to provide makeup control air to the accumulator for V-11-36 for the isolation condenser makeup line due to the loss of instrument air. If OMA #18 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 29 minutes, while the time available is 300 minutes, which provides a 241-minute margin.
Given the limited amount of combustible materials, ignition sources, and the large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection or sprinkler systems noted above, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this zone, combined with the ability of OMA #18 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the main combustible in this area is attributed to cable insulation (approximately 84% of loading).
The licensee stated that RB-FZ-1D has an area-wide smoke detection system and an automatic fixed deluge water spray system installed over cable trays and open hatches. The deluge suppression system protecting safety related cable trays is automatically activated by a cross-zoned detection system consisting of linear heat detection wire located on top of the cables in each original safety related cable tray and smoke detectors are located in each beam pocket at the ceiling.
The licensee stated that RB-FZ-1D has a ceiling height of approximately 21′-0″ and an approximate floor area of 9,100 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and the large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection or localized water deluge systems noted above, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the main combustible in this area is attributed to cable insulation (approximately 84% of loading).
The licensee stated that RB-FZ-1E has an area-wide smoke detection system and an automatic fixed deluge water spray system installed over cable trays and open hatches. The deluge suppression system protecting safety related cable trays is automatically activated by a cross-zoned detection system consisting of linear heat detection wire located on top of the cables in each original safety related cable tray and smoke detectors are located in each beam pocket at the ceiling.
The licensee stated that RB-FZ-1E has a ceiling height of approximately 26′-9″ and an approximate floor area of 12,140 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and the large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection or localized water deluge systems noted above, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this zone, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the major combustibles in this area are cable insulation (approximately 58% of loading), ladders (approximately 16% of loading) and lubricating oil in pumps (approximately 16% of loading).
The licensee stated that RB-FZ-1F3 has smoke detectors which alarm locally and in the control room installed over hazards rather than mounted at the ceiling. Fire extinguishers are also provided for manual fire fighting backup. Hose lines are available from outside hydrants and hose houses.
The licensee stated that RB-FZ-1F3 has a ceiling height of approximately 41′-6″ and an approximate floor area of 560 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection system or personnel and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the major combustibles in this area are cable insulation (approximately 19% of loading) and gratings (approximately 76% of loading). The grating, which is the largest plastic material in this area, has a low flame spread rating (less than 25).
The licensee stated that RB-FZ-1F5 does not have detection or suppression systems. However, due to the limited combustible loading and the nature of the combustibles, a fire in this zone is not expected to be of significant size or duration.
The licensee stated that RB-FZ-1F5 is a voluminous area with an approximate floor area of 11,450 square feet and a ceiling height of approximately 41′-6″ therefore, it is unlikely that smoke and heat from a fire in the area would accumulate at the location of the instrument air line and cause a loss of instrument air.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and the large volume of the area, it is unlikely that a fire would occur and go undetected or unsuppressed by personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional
The licensee stated that RB-FZ-1G is provided with a smoke detection system that alarms locally and in the control room to provide prompt notification of a potential fire event.
The licensee stated that RB-FZ-1G has a ceiling height of approximately 21′, measured from the 51′-3″ elevation, and an approximate floor area of 1,609 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection system or personnel and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this area is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that there are minimal amounts of cable insulation (approximately 5% of loading) miscellaneous plastic (approximately 73% of loading) and class A combustibles such as paper for procedures (approximately 20% of loading) in this area.
The licensee stated that TB-FA-3A is provided with an area-wide smoke detection system and a total-flooding, manually actuated CO2 system.
The licensee stated that TB-FA-3A has a ceiling height of approximately 21′ and an approximate floor area of 336 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally,
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection or CO2 systems, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMA #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this area is moderate and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the major combustibles in this area are plastic, which is contributed by the battery cases (approximately 92% of loading) and cable insulation (approximately 6% of loading).
The licensee stated that TB-FA-26 has an area-wide automatic pre-action sprinkler system and an area-wide smoke detection system installed.
The licensee stated that there are no specific cables in this fire area associated with the OMAs identified for Fire Area TB-FA-26 and that the only fire safe shutdown component and cable located in this fire area is associated with the “C” battery.
The licensee stated that this fire area is wholly contained within Fire Zone TB-FZ-11C (A and B 4160V Room) and that all cables to TB-FA-26 must traverse TB-FZ-11C. Therefore, TB-FA-26 and TB-FZ-11C were analyzed together for safe shutdown purposes and the OMAs are duplicated for these two plant areas. Refer to Section 3.16 below for the discussion of OMAs #1, #2, #3, #7, #8, and #18.
Given the limited amount of combustible materials, ignition sources, and lack of multiple safe shutdown trains in this area, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection or sprinkler systems, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMAs #1, #2, #3, #7, #8, and #18 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is high and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the major combustibles in this area are lubricating oil (approximately 99% of loading) and cable insulation (approximately 0.3% of loading).
The licensee stated that TB-FZ-11B has automatic suppression systems installed over principal combustibles and a rate of rise/fixed temperature fire detection system installed at the lube oil tank. A closed head automatic sprinkler system protects cable trays and open head water spray deluge system protects oil handling equipment and the oil storage tank. Thermal detectors are located in close proximity to the lube oil tank so that a lube oil fire would be quickly detected, which in turn would activate the deluge system for extinguishment. Additionally, the licensee stated that there are fire extinguishers provided throughout the zone and that aqueous film-forming foam (AFFF) is staged in the Fire Brigade van for use if necessary.
The licensee stated that the ceiling heights in the area are approximately 9′-0″ in the basement hallway, approximately 19′-0″ in the basement stairs, approximately 26′-0″ on the first floor of the area, and approximately 42′-0″ on the second floor of the area. Additionally, the licensee stated that the floor area, measured at the 0′-0″ elevation is approximately 3175 square feet.
In order for OMA #3 to be necessary, the credited and redundant cables would have to be damaged due to a fire. The licensee stated that these cables are located in the same tray with additional cables and are generally located approximately 14 feet above the floor. The licensee also stated that the cables pass over the top of potential ignition sources MCC 1A12 and MCC 1B12 and that the cables are located approximately 6 feet above these ignition sources. Additionally, the lube oil tanks are located below the cables, although not directly below, with a distance of approximately 26 feet separating the cables and the tanks. The cables are also located approximately 20 feet from ignition sources MCC 1A12A and 1B12A.
In the unlikely event that a fire does occur and damages the credited and redundant cables, OMA #3 is available to manually control the 480V USS 1B2 Breakers for CRD Pump NC08B and 1B2M from the Remote Shutdown Panel due to control circuit damage. The licensee also stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 8 minutes while the time available is 180 minutes, which provides a 142-minute margin.
In order for OMA #18 to be necessary, a loss of instrument air to the isolation condenser valve V-11-36 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout
The licensee also stated that OMA #18 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-36 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #18 is available to provide makeup control air to the accumulator for V-11-36 for the isolation condenser makeup line due to the loss of instrument air. If OMA #18 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Although the fire loading is high, the limited ignition sources, large volume of the space, and the detection and suppression system make it unlikely that a fire would occur and go undetected or unsuppressed and damage the safe shutdown equipment. Additionally, the availability of fire extinguishers and AFFF, which is effective against oil based fires, provides an augmented ability to suppress a fire prior to damaging safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this zone, combined with the ability of OMAs #3 and #18 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the main combustible loading is attributed to cable insulation (approximately 73% of loading) and plastic (approximately 17% of loading).
The licensee stated that TB-FZ-11C has an area-wide smoke detection system and an area-wide automatic fixed pre-action sprinkler system (except in the small caged area located to the east of Fire Area TB-FA-3A) installed.
The licensee stated that TB-FZ-11C has a ceiling height of approximately 21′-8″ and an approximate floor area of 2666 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #1 to be necessary, damage to the 1A and 1B 4160V Switchgear Cabinets and the “C” Battery distribution panel, or the associated control wiring, would have to occur due to a fire and prevent tripping of the 4160V motor-generator set breakers. The licensee stated that these cables are located in the same tray with additional cables and are generally located at least 17 feet above the floor. The licensee also stated that the tray passes over the top of potential ignition source “B” 4160V switchgear and that the cables are located approximately 9 feet above this ignition source and 3 feet above the iso-phase bus duct at their closest point.
In the unlikely event that a fire does occur and damages the credited and redundant equipment, OMA #1 is available to trip the field breakers for the recirculation pumps motor-generator set so that the Fuel Zone Level Indicators can be used. The licensee also stated that they have assumed a 10-minute diagnosis period and that the required time to perform the action is 8 minutes while the time available is 30 minutes, which provides a 12-minute margin.
In order for OMA #2 to be necessary, loss of the “B” train of power would have to occur due to a fire causing a loss of both condensate transfer pumps. The licensee stated that this OMA is dependent on the LSP-1D OMA, which was included in the licensee's Phase 1 request, and would not be required unless the OMA at the LSP-1D is required and access is not immediately available. As such, this OMA is considered a contingency action. The licensee also stated that these cables are located in the same tray with additional cables and are generally located at least 17 feet above the floor and that the tray passes over the top of potential ignition source “B” 4160V switchgear and that the cables are located approximately 9 feet above this ignition source and 3 feet above the iso-phase bus duct at their closest point.
In the unlikely event that a fire does occur and damages the credited and redundant cables, OMA #2 is available to provide fire water to the isolation condenser shell by operating valves V-9-2099, V-11-49, V-11-63, and V-11-41 due to loss of power. The licensee also stated that they have assumed a 10-minute diagnosis period and that the required time to perform the action is 13 minutes while the time available is 45 minutes, which provides a 22-minute margin.
In order for OMA #3 to be necessary, the credited and redundant cables would have to be damaged due to a fire. The licensee stated that these cables are located in the same tray with additional cables and are generally located at least 17 feet above the floor. The licensee also stated that the tray passes over the top of potential ignition source “B” 4160V switchgear and that the cables are located approximately 9 feet above this
In the unlikely event that a fire does occur and damages the credited and redundant cables, OMA #3 is available to manually control the 480V USS 1B2 Breakers for CRD Pump NC08B and 1B2M from the Remote Shutdown Panel due to control circuit damage. The licensee also stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 8 minutes while the time available is 180 minutes, which provides a 142-minute margin.
In order for OMA #7 to be necessary, loss of the “B” train of power would have to occur due to a fire causing a loss of both condensate transfer pumps. The licensee stated that this OMA is dependent on the LSP-1D OMA, which was included in the licensee's Phase 1 request, and would not be required unless the OMA at the LSP-1D is required and access is not immediately available. As such, this OMA is considered a contingency action. The licensee also stated that these cables are located in the same tray with additional cables and are generally located at least 17 feet above the floor and that the tray passes over the top of potential ignition source “B” 4160V switchgear and that the cables are located approximately 9 feet above this ignition source and 3 feet above the iso-phase bus duct at their closest point.
In the unlikely event that a fire does occur and damages the credited and redundant cables, OMA #7 is available to manually open V-11-36 to provide makeup to Isolation Condenser due to loss of power. The licensee also stated that they have assumed a 10-minute diagnosis period and that the required time to perform the action is 16 minutes while the time available is 45 minutes, which provides a 19-minute margin.
In order for OMA #8 to be necessary, loss of the “B” train of power would have to occur due to a fire causing a loss of both condensate transfer pumps. The licensee stated that this OMA is dependent on the LSP-1D OMA, which was included in the licensee's Phase 1 request, and would not be required unless the OMA at the LSP-1D is required and access is not immediately available. As such, this OMA is considered a contingency action. The licensee also stated that these cables are located in the same tray with additional cables and are generally located at least 17 feet above the floor and that the tray passes over the top of potential ignition source “B” 4160V switchgear and that the cables are located approximately 9 feet above this ignition source and 3 feet above the iso-phase bus duct at their closest point.
In the unlikely event that a fire does occur and damages the credited and redundant cables, OMA #8 is available to check the isolation condenser shell level locally due to loss of power. The licensee also stated that they have assumed a 10-minute diagnosis period and that the required time to perform the action is 16 minutes while the time available is 45 minutes, which provides a 19-minute margin.
In order for OMA #18 to be necessary, a loss of instrument air to the isolation condenser valve V-11-36 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #18 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-36 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the main MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #18 is available to provide makeup control air to the accumulator for V-11-36 for the isolation condenser makeup line due to the loss of instrument air. If OMA #18 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the smoke detection or sprinkler systems noted above, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMAs #1, #2, #3, #7, #8, and #18 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provide adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the major combustibles in this area are cable insulation (approximately 29% of loading), Dow Corning 561 Silicon transformer liquid (approximately 15% of loading) and lubricating oil (approximately 40% of loading).
The licensee stated that an automatic wet-pipe sprinkler system and an automatic water spray system located at the hydrogen seal oil unit are installed in the area.
The licensee stated that TB-FZ-11D has a ceiling height of approximately 19′ and an approximate floor area of 9668 square feet so it is unlikely that smoke and heat would accumulate at the
In order for OMA #1 to be necessary, damage to the 1A and 1B 4160V Switchgear Cabinets and the “C” Battery distribution panel, or the associated control wiring, would have to occur due to a fire and prevent tripping of the 4160V MG set breakers. The licensee stated that these cables are located in the same tray with additional cables and are generally located at least 15 feet above the floor. The primary combustible fuel load in the area is the cables themselves and storage of transient combustibles is limited due to a sump and abandoned acid/caustic tanks located in the area.
The licensee also stated that the primary ignition sources in the area near the cable trays are the Turbine Building Closed Cooling Water Pumps and USS 1A1 and its associated transformer (4160V to 480V transformer). However, the Turbine Building Closed Cooling Water Pumps contain less than 5 gallons of oil and are enclosed in metal casings and the cable tray containing the cables is approximately 13 feet from the top of the pumps/motors. The top of USS 1A1 and its associated transformer are located approximately 30 feet diagonally from the credited cables and approximately 15 feet diagonally from the redundant cables. Additionally, there is a concrete ceiling beam, with a water curtain sprinkler system attached, which would provide some shielding for the cables from potential products of combustion generated by this ignition source. Sprinkler heads are also located in a ceiling pocket between the concrete ceiling beam and the USS 1A1 and transformer.
In the unlikely event that a fire does occur and damages the credited and redundant equipment, OMA #1 is available to trip the field breakers for the recirculation pumps MG Set so that the fuel zone level indicators can be used. The licensee also stated that they have assumed a 10-minute diagnosis period and that the required time to perform the action is 8 minutes while the time available is 30 minutes, which provides a 12-minute margin.
In order for OMA #2 to be necessary, loss of the “B” train of power would have to occur due to a fire causing a loss of both condensate transfer pumps. The licensee stated that this OMA is dependent on the LSP-1D OMA, which was included in the licensee's Phase 1 request, and would not be required unless the OMA at the LSP-1D is required and access is not immediately available. As such, this OMA is considered a contingency action. In addition, the licensee stated that these cables are located in the same tray with additional cables and are generally located at least 15 feet above the floor. The primary combustible fuel load in the area is the cables themselves and storage of transient combustibles is limited due to a sump and abandoned acid/caustic tanks located in the area.
The licensee also stated that the primary ignition sources in the area near the cable trays are the Turbine Building Closed Cooling Water Pumps and USS 1A1 and its associated transformer (4160V to 480V transformer). However, the Turbine Building Closed Cooling Water Pumps contain less than 5 gallons of oil and are enclosed in metal casings and the cable tray containing the cables is approximately 13 feet from the top of the pumps/motors. The top of USS 1A1 and its associated transformer are located approximately 30 feet diagonally from the credited cables and approximately 15 feet diagonally from the redundant cables. Additionally, there is a concrete ceiling beam, with a water curtain sprinkler system attached, which would provide some shielding for the cables from potential products of combustion generated by this ignition source. Sprinkler heads are also located in a ceiling pocket between the concrete ceiling beam and the USS 1A1 and transformer.
In the unlikely event that a fire does occur and damages the credited and redundant cables, OMA #2 is available to provide fire water to the isolation condenser shell by operating valves V-9-2099, V-11-49, V-11-63, and V-11-41 due to loss of power. The licensee also stated that they have assumed a 10-minute diagnosis period and that the required time to perform the action is 13 minutes while the time available is 45 minutes, which provides a 22-minute margin.
In order for OMA #3 to be necessary, the credited and redundant cables would have to be damaged due to a fire. The licensee stated that these cables are located in the same tray with additional cables and are generally located at least 15 feet above the floor. The primary combustible fuel load in the area is the cables themselves and storage of transient combustibles is limited due to a sump and abandoned acid/caustic tanks located in the area.
The licensee also stated that the primary ignition sources in the area near the cable trays are the Turbine Building Closed Cooling Water Pumps and USS 1A1 and its associated transformer (4160V to 480V transformer). However, the Turbine Building Closed Cooling Water Pumps contain less than 5 gallons of oil and are enclosed in metal casings and the cable tray containing the cables is approximately 13 feet from the top of the pumps/motors. The top of USS 1A1 and its associated transformer are located approximately 30 feet diagonally from the credited cables and approximately 15 feet diagonally from the redundant cables. Additionally, there is a concrete ceiling beam, with a water curtain sprinkler system attached, which would provide some shielding for the cables from potential products of combustion generated by this ignition source. Sprinkler heads are also located in a ceiling pocket between the concrete ceiling beam and the USS 1A1 and transformer.
In the unlikely event that a fire does occur and damages the credited and redundant cables, OMA #3 is available to manually control the 480V USS 1B2 Breakers for CRD Pump NC08B and 1B2M from the Remote Shutdown Panel due to control circuit damage. The licensee also stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 8 minutes while the time available is 180 minutes, which provides a 142-minute margin.
In order for OMA #7 to be necessary, loss of the “B” train of power would have to occur due to a fire causing a loss of both condensate transfer pumps. The licensee stated that this OMA is dependent on the LSP-1D OMA, which was included in the licensee's Phase 1 request, and would not be required unless the OMA at the LSP-1D is required and access is not immediately available. As such, this OMA is considered a contingency action. In addition, the licensee stated that these cables are located in the same tray with additional cables and are generally located at least 15 feet above the floor. The primary combustible fuel load in the area is the cables themselves and storage of transient combustibles is limited due to a sump and abandoned acid/caustic tanks located in the area.
The licensee also stated that the primary ignition sources in the area near the cable trays are the Turbine Building
In the unlikely event that a fire does occur and damages the credited and redundant cables, OMA #7 is available to manually open V-11-36 to provide makeup to Isolation Condenser due to loss of power. The licensee also stated that they have assumed a 10-minute diagnosis period and that the required time to perform the action is 16 minutes while the time available is 45 minutes, which provides a 19-minute margin.
In order for OMA #8 to be necessary, loss of the “B” train of power would have to occur due to a fire causing a loss of both condensate transfer pumps. The licensee stated that this OMA is dependent on the LSP-1D OMA, which was included in the licensee's Phase 1 request, and would not be required unless the OMA at the LSP-1D is required and access is not immediately available. As such, this OMA is considered a contingency action. In addition, the licensee stated that these cables are located in the same tray with additional cables and are generally located at least 15 feet above the floor. The primary combustible fuel load in the area is the cables themselves and storage of transient combustibles is limited due to a sump and abandoned acid/caustic tanks located in the area.
The licensee also stated that the primary ignition sources in the area near the cable trays are the Turbine Building Closed Cooling Water Pumps and USS 1A1 and its associated transformer (4160V to 480V transformer). However, the Turbine Building Closed Cooling Water Pumps contain less than 5 gallons of oil and are enclosed in metal casings and the cable tray containing the cables is approximately 13 feet from the top of the pumps/motors. The top of USS 1A1 and its associated transformer are located approximately 30 feet diagonally from the credited cables and approximately 15 feet diagonally from the redundant cables. Additionally, there is a concrete ceiling beam, with a water curtain sprinkler system attached, which would provide some shielding for the cables from potential products of combustion generated by this ignition source. Sprinkler heads are also located in a ceiling pocket between the concrete ceiling beam and the USS 1A1 and transformer.
In the unlikely event that a fire does occur and damages the credited and redundant cables, OMA #8 is available to check the isolation condenser shell level locally due to loss of power. The licensee also stated that they have assumed a 10-minute diagnosis period and that the required time to perform the action is 16 minutes while the time available is 45 minutes, which provides a 19-minute margin.
In order for OMA #18 to be necessary, a loss of instrument air to the isolation condenser valve V-11-36 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #18 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-36 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #18 is available to provide makeup control air to the accumulator for V-11-36 for the isolation condenser makeup line due to the loss of instrument air. If OMA #18 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources and the volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the suppression systems noted above, or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this zone, combined with the ability of OMAs #1, #2, #3, #7, #8, and #18 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the major combustibles in this area are cable insulation (approximately 40% of loading) and plastic (approximately 59% of loading). The grating, which is the largest plastic material in this area, is dispersed throughout this fire zone (not concentrated) and has a low flame spread (less than 25). The licensee also stated that this Fire Zone is procedurally controlled as a transient combustible free area while the plant is operating and that this area is a high
The licensee stated that a closed head automatic sprinkler and spray systems protect the south end basement area and the hydrogen seal oil unit. An exemption was granted from the requirements of Appendix R Section III.G.2 in safety evaluations dated March 24, 1986, and June 25, 1990, for not having fixed fire detection in this area. The primary basis for this exemption was the presence of the automatic wet pipe sprinkler system and low fire loading. The Condenser Bay is procedurally controlled as a transient combustible free area in while the plant is operating. If a fire did occur, the flow alarm would notify the control room of any sprinkler system activation. Extinguishment of a fire can be accomplished by the automatic fixed suppression system and the plant fire brigade. A closed head automatic sprinkler system was recently expanded to provide fire suppression over the cables in cable trays in the northeast side of the condenser bay.
The licensee stated that TB-FZ-11E has a ceiling height of at least 40′ and an approximate floor area of 26,427 square feet so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #3 to be necessary, the credited and redundant cables would have to be damaged due to a fire. The licensee stated that these cables are located in the same tray with additional cables and are generally located approximately 40 feet above the floor. With the exception of the cables themselves, there are no other ignition sources or combustibles located near the cables.
In the unlikely event that a fire does occur and damages the credited and redundant cables, OMA #3 is available to manually control the 480V USS 1B2 Breakers for CRD Pump NC08B and 1B2M from the Remote Shutdown Panel due to control circuit damage. The licensee also stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 8 minutes while the time available is 180 minutes, which provides a 142-minute margin.
In order for OMA #18 to be necessary, a loss of instrument air to the isolation condenser valve V-11-36 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #18 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-36 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #18 is available to provide makeup control air to the accumulator for V-11-36 for the isolation condenser makeup line due to the loss of instrument air. If OMA #18 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the suppression system noted above or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this zone, combined with the ability of OMAs #3 and #18 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the major combustible load consists of cable insulation (approximately 15% of loading), lubricating oil (approximately 39% of loading), rubber (approximately 21% of loading) and plastics (approximately 17% of loading). The licensee states that the majority of the combustible loading attributed to rubber and plastic was due to the storage of hoses that are now no longer in the area.
The licensee stated that TB-FZ-11F has an area-wide thermal fire detection system. Extinguishment of the fire will be accomplished by the plant fire brigade.
The licensee stated that TB-FZ-11F has a ceiling height of approximately 16′ in approximately 70% of the area and approximately 19′-6″ in the remainder of the area. With an approximate floor area of 5650 square feet, it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #18 to be necessary, a loss of instrument air to the isolation condenser valve V-11-36 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #18 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-36 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #18 is available to provide makeup control air to the accumulator for V-11-36 for the isolation condenser makeup line due to the loss of instrument air. If OMA #18 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the thermal detection system noted above or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this zone, combined with the ability of OMA #18 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that the fire loading in this zone is low and that there is an administrative controls program in place to limit additional combustible materials and sources of ignition. The licensee also stated that the major combustibles are cable insulation (approximately 23% of loading), ladders and other miscellaneous plastics (approximately 55% of loading) and miscellaneous ordinary combustibles.
The licensee stated that TB-FZ-11H has a partial area thermal fire detector system. The system alarms locally and in the control room. Manual extinguishment of fire will be accomplished by the plant fire brigade.
The licensee stated that TB-FZ-11H has a ceiling height of approximately 7′-0″, measured at the 3′-6″ elevation, and approximately 19′-0″, measured at the 23′-6″ elevation with an approximate floor area of 3,944 square feet and 4,366 square feet, respectively, so it is unlikely that smoke and heat would accumulate at the height of the safe shutdown equipment and cause a failure due to fire damage.
In order for OMA #18 to be necessary, a loss of instrument air to the isolation condenser valve V-11-36 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #18 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-36 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #18 is available to provide makeup control air to the accumulator for V-11-36 for the isolation condenser makeup line due to the loss of instrument air. If OMA #18 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26
Given the limited amount of combustible materials, ignition sources, and large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the thermal detection system noted above or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this zone, combined with the ability of OMA #18 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
The licensee stated that no specific quantification of fire loading was considered necessary for the Yard area since it is an outdoor area with no ceiling or physical boundaries to contain heat and smoke from a fire event.
The licensee stated that there is no fire detection or fixed fire suppression systems installed in this area but that manual suppression is provided by a hose station from the office building and by fire hydrants located throughout the Yard area.
Since the Yard area is an outdoor space with no walls or ceiling, smoke and heat would not accumulate within the fire area to cause damage to components remote to the initiating fire or obstruct operator actions.
In order for OMA #12 to be necessary, a loss of instrument air to the CRD flow control valve would have to occur due to fire damage. The licensee stated that the normal CRD flow control valve is a single component without a redundant counterpart. Because of this, a manual bypass is provided to maintain flow around the CRD flow control valves that fail closed upon loss of instrument air or control cable damage.
In the unlikely event that a fire does occur and causes the normal flow control valve to be unavailable due to a loss of instrument air or cable damage, OMA #12 is available to manually open V-15-237, throttle V-15-30 while monitoring flow at FI-225-2, and close V-15-52 to establish CRD flow to the reactor. Furthermore, OMA #12 would only be necessary if the Isolation Condenser/CRD systems are utilized for hot shutdown. If OMA #12 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 15 minutes, while the time available is 204 minutes, which provides a 159-minute margin.
In order for OMA #17 to be necessary, a loss of instrument air to the isolation condenser valve V-11-34 would have to occur due to fire damage. The licensee stated that they conservatively assume that instrument air is lost for all Appendix R fires based on the fact that instrument air lines run throughout many areas of the plant. The licensee's analysis assumes that the air line could potentially fail in approximately 45 minutes when exposed to the postulated fire.
The licensee also stated that OMA #17 connects a high pressure air cylinder to the accumulator of Condensate Transfer System valve V-11-34 and that these air-operated valves are used to control makeup to the isolation condensers. Each valve is provided with an air accumulator that provides a minimum of six full cycles. As a result, this OMA is only necessary to ensure long-term operation of these valves and makeup to the isolation condensers. Further, this OMA would only be necessary if the plant had to remain in hot shutdown for an extended time. This scenario is unlikely for this particular area since the plant would likely reach cold shutdown before the action is required.
In addition, the licensee stated that they maintain a fire support procedure (ABN-35, “Loss of Instrument Air”) that provides guidance to perform this OMA if instrument air is lost and indicates that there are four annunciator alarm windows that monitor instrument air pressure, plus a pressure gauge on a panel in the control room for instrument air pressure. If all of these instruments are not available, then ABN-35 further indicates that the control rods will start to drift into the core and the MSIVs will close, as well as multiple air-operated valves changing state. Additionally, RPV level indication will not be compromised by a fire in any zone or area. All of these indications would help the operator diagnose the loss of instrument air and initiate mitigating procedures.
In the unlikely event that a fire does occur and causes a loss of instrument air to the air-operated valves, OMA #17 is available to provide makeup control air to the accumulator for V-11-34 for the isolation condenser makeup line due to the loss of instrument air. If OMA #17 becomes necessary, the licensee stated that they have assumed a 30-minute diagnosis period and that the required time to perform the action is 26 minutes, while the time available is 300 minutes, which provides a 244-minute margin.
Given the limited amount of combustible materials, ignition sources, and large volume of the space, it is unlikely that a fire would occur and go undetected or unsuppressed by the thermal detection system noted above or personnel, and damage the safe shutdown equipment. The low likelihood of damage to safe shutdown equipment due to a fire in this area, combined with the ability of OMAs #12 and #17 to manipulate the plant in the event of a fire that damages safe shutdown equipment, provides adequate assurance that safe shutdown capability is maintained.
This analysis postulates that OMAs may be needed to assure safe shutdown capability in addition to the traditional fire protection features described above. NUREG-1852, “Demonstrating the Feasibility and Reliability of Operator Manual Actions in Response to Fire,” provides criteria and associated technical bases for evaluating the feasibility and reliability of post-fire OMAs in nuclear power plants. The following provides the Oyster Creek analysis of these criteria for justifying the OMAs specified in this exemption.
Using NUREG-1852, the NRC staff has evaluated the feasibility and reliability review provided by the licensee in the April 2, 2010, Response to Request for Additional Information. For an OMA to be considered feasible, the required actions must be proceduralized, any equipment that is needed to implement the OMA is available, the environments in which the OMA is to be performed must permit the action, and the time taken to diagnose the need for the OMA and implement it (time required) must be
The feasibility review provided by the licensee documents that procedures are in place, in the form of fire response procedures, to ensure that clear and accessible instructions on how to perform the manual actions are available to the operators. All of the requested OMAs are directed by plant procedures, and the operators are trained in the use of the procedures. Specifically, the licensee stated that procedure ABN-29, Plant Fires, is entered whenever a fire or indication of a fire occurs on the main fire alarm panel in the control room or at any local fire alarm panel. In addition to dispatching a radio-equipped operator to the alarming location, ABN-29 also directs that the fire brigade be dispatched whenever a fire suppression system has actuated (sprinkler, deluge, Halon, or CO
• Fire detection alarm and equipment malfunction indication or alarms within the same area;
• Fire pump start and either sprinkler flow alarm or deluge flow alarm;
• Gaseous suppression system actuation;
• Report from the field of an actual smoke condition or actual fire condition; or
• Fire detection alarm with follow up confirmation by field operator.
Entering the FSP means that the operator will review the FSP, identify equipment that could be affected, identify equipment that will be available, monitor plant equipment from the control room and communicate with the fire brigade leader. Based on the symptoms received in the control room and the feedback from the fire brigade leader, the operator will decide using the procedure what mitigating actions are necessary. In the event that a plant shutdown has occurred before the FSP is entered, the operator will still enter the FSP based on the fire and initiate the OMAs as appropriate. OMAs that are considered “prompt” (i.e., those that must be done within 45 minutes or less) are identified in both ABN-29 and in the applicable FSPs as an item requiring immediate attention. The operators are trained to perform prompt actions first and prioritize them based upon existing plant conditions. The FSPs are based on the worst-case loss considerations by assuming all fire damage occurs instantaneously and thus all operator manual actions will be required. The use of the Emergency Operating Procedures in conjunction with the applicable FSPs will permit the use of any mitigating system available first, and if a desired system is not available, the FSP provides a contingency action to restore the system or provide another means to perform the function. Operator training, including simulator demonstrations and plant walk downs, has been performed to ensure consistency in operator and team response for each OMA.
The licensee evaluated several potential environmental concerns, such as radiation levels, temperature/humidity conditions and the ventilation configuration and fire effects that the operators may encounter during certain emergency scenarios. The licensee's feasibility review concluded that the operators performing the manual actions would not be exposed to adverse or untenable conditions during any particular operator manual action procedure or during the time to perform the procedure. The licensee stated that OMAs required for achieving and maintaining hot shutdown conditions are not impacted by environmental conditions associated with fires in the fire area identified in the request. Each of the safe shutdown calculations that provide the technical basis for the FSPs contains a timeline for operator actions for the specific fire area. In addition, the licensee stated that the equipment needed to implement OMAs remains available and the fire areas remain accessible during or following the event.
The licensee's analysis demonstrates that, for the expected scenarios, the OMAs can be diagnosed and executed within the amount of time available to complete them. The licensee's analysis also demonstrates that various factors, as discussed above, have been considered to address uncertainties in estimating the time available. Therefore, the OMAs included in this review are feasible because there is adequate time available for the operator to perform the required OMAs to achieve and maintain hot shutdown following a postulated fire event. Table 2 summarizes the “required” verses “available” times for each OMA. The licensee has included any diagnosis time as part of the required time for performing a particular action. Where an action has multiple times or contingencies associated with the “available” completion time, the lesser time is used. This is approach is considered to represent a conservative approach to analyzing the timelines associated with each of the OMAs with regard to the feasibility and reliability of the actions included in this exemption. The licensee provided a discussion of the times and circumstances associated with each of the actions in their March 3, 2009, and April 2, 2010, correspondence.
The NRC staff reviewed the required operator manual action completion time limits versus the time before the action becomes critical to safely shutting down the unit as presented in the feasibility analyses. The NRC staff recognizes that, in some cases the time required neared the time available for an OMA. The NRC staff, however, also recognizes that there are conservatisms built in to these time estimates such as adding in the entire time assumed to diagnose the need for an OMA where in reality, the actual time take would likely be less.
The NRC staff notes that, in one case, an OMA must be completed within 30 minutes (i.e., it is considered a prompt action). This action is identified as OMA #1 and requires an operator to trip the field breakers for the recirculation pumps MG set so that the Fuel Zone Level Indicators can be used. The action may be required as a result of fire in TB-FA-26, TB-FZ-11C, or TB-FZ-11D. The symptom for this action is the inability to trip the Recirculation Pumps from the control room and this is detected using the associated pump breaker indicating lights, alarms and flow indications. The Fire Support Procedures direct the operator to trip the pumps using the pump control switches or the Recirculation Pump Trip circuitry (two trip coils for pumps). If both of these methods fail on one or more pumps, the guidance is given to trip the pumps from the 4160V Switchgear 1A and 1B located outside the control room in Fire Area TB-FZ-11C. Only one operator would be required and it would take approximately 13 minutes for access to the area and to perform the action of tripping the breakers. Given the low complexity of this action, the NRC staff finds that there is a sufficient amount of time available to complete the proposed operator manual actions.
The completion times noted in the table above provide reasonable assurance that the OMAs can reliably be performed under a wide range of conceivable conditions by different plant crews. This is because the time margins associated with each action and other installed fire protection features, account for sources of uncertainty such as variations in fire and plant conditions, factors unable to be recreated in demonstrations and human-centered factors. Therefore, the OMAs included in this review are reliable because there is adequate time available to account for uncertainties not only in estimates of the time available, but also in estimates of how long it takes to diagnose a fire and execute the OMAs. This is based, in part, on a plant demonstration of the actions under non-fire conditions.
In summary, the defense-in-depth concept for a fire in the fire areas discussed above provides a level of safety that limits the occurrence of fires and results in rapid detection, control and extinguishment of fires that do occur and the protection of structures, systems and components important to safety. It should be understood that the OMAs are a fall back in the unlikely event that the fire protection defense-in-depth features are insufficient. In most cases, there is no credible fire scenario that would necessitate the performance of these OMAs. As discussed above, the licensee has provided preventative and protective measures in addition to feasible and reliable OMAs that together demonstrate the licensee's ability to preserve or maintain safe shutdown capability in the event of a fire in the analyzed fire areas.
This exemption would allow Oyster Creek to rely on OMAs, in conjunction with the other installed fire protection features, to ensure that at least one means of achieving and maintaining hot shutdown remains available during and following a postulated fire event, as part of its fire protection program, in lieu of meeting the requirements specified in 10 CFR Part 50, Appendix R, Section III.G.2 for a fire in the analyzed fire areas. As stated above, 10 CFR 50.12 allows the NRC to grant exemptions from the requirements of 10 CFR Part 50. The NRC staff has determined that granting of this exemption will not result in a violation of the Atomic Energy Act of 1954, as amended, or the Commission's regulations. Therefore, the exemption is authorized by law.
The underlying purpose of 10 CFR Part 50, Appendix R, Section III.G is to ensure that at least one means of achieving and maintaining hot shutdown remains available during and following a postulated fire event. Based on the above evaluation, the NRC staff finds that the plant features, as described in the March 3, 2009, submittal, as supplemented by letter dated April 2, 2010, should limit the occurrence and impacts of any fire that may occur. This, combined with the ability of the OMAs to place and maintain the plant in a safe condition in the event of a fire that does damage safe shutdown equipment, provides adequate protection of public health and safety. Therefore, there is no undue risk to public health and safety.
This exemption would allow Oyster Creek to credit the use of the specific OMAs, in conjunction with the other installed fire protection features, in response to a fire in the analyzed fire areas, discussed above, in lieu of meeting the requirements specified in III.G.2. This change, to the operation of the plant, has no relation to security issues nor does it diminish the level of safety from what was intended by the requirements of III.G.2. Therefore, the common defense and security is not diminished by this exemption.
One of the special circumstances described in 10 CFR 50.12(a)(2)(ii) is that the application of the regulation is not necessary to achieve the underlying purpose of the rule. The underlying purpose of 10 CFR Part 50, Appendix R, Section III.G is to ensure that at least one means of achieving and maintaining hot shutdown remains available during and following a postulated fire event. While the licensee does not comply with the explicit requirements of III.G.2, specifically, they do meet the underlying purpose of 10 CFR Part 50, Appendix R, and Section III.G as a whole. Therefore, special circumstances exist that warrant the issuance of this exemption as required by 10 CFR 50.12(a)(2)(ii).
Accordingly, the Commission has determined that, pursuant to 10 CFR 50.12(a), the exemption is authorized by law, will not present an undue risk to the public health and safety, is consistent with the common defense and security and that special circumstances are present to warrant issuance of the exemption. Therefore, the Commission hereby grants Exelon an exemption from the requirements of Section III.G.2 of Appendix R of 10 CFR Part 50, to utilize the OMAs discussed above at Oyster Creek.
Pursuant to 10 CFR 51.32, the Commission has determined that the granting of this exemption will not have a significant effect on the quality of the human environment (75 FR 33656).
This exemption is effective upon issuance.
For the Nuclear Regulatory Commission.
U.S. Nuclear Regulatory Commission (NRC).
Notice of Availability.
The NRC is announcing the availability of the model application (with model no significant hazards consideration (NSHC) determination) and model safety evaluation (SE) for plant-specific adoption of TSTF Traveler TSTF-422, Revision 2, “Change in Technical Specifications End States (CE NPSD-1186),” for CE plants using the CLIIP. TSTF-422, Revision 2, is available in the Agencywide Documents Access and Management System (ADAMS) under Accession Number ML093570241. TSTF-422, Revision 2, modifies the Required Action with the preferred end state with the addition of a Note to prohibit the use of the provisions of Limiting Condition for Operation 3.0.4.a to enter the end state Mode within the Applicability during startup. The Bases of each Required Action is revised to describe the Note. This model SE will facilitate expedited approval of plant-specific adoption of TSTF-422, Revision 2. Please note, this NOA supersedes in its entirety the NOA for TSTF-422, Revision 1, published in the
You can access publicly available documents related to this notice using the following methods:
The model application (with model NSHC determination) and model SE for plant-specific adoption of TSTF-422, Revision 2, are available electronically under ADAMS Accession Number ML103270197. No comments were received to the Notice of Opportunity for Public Comment announced in the
Ravinder Grover, Technical Specifications Branch, Mail Stop: O-7 C2A, Division of Inspection and Regional Support, Office of Nuclear Reactor Regulation, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001;
TSTF-422, Revision 2, is applicable to all CE PWR plants. Licensees opting to apply for this TS change are responsible for reviewing the NRC staff's model SE, referencing the applicable technical justifications, and providing any necessary plant-specific information. The NRC will process each amendment application responding to this NOA according to applicable NRC rules and procedures.
The proposed models do not prevent licensees from requesting an alternate approach or proposing changes other than those proposed in TSTF-422, Revision 2. However, significant deviations from the approach recommended in this notice or the inclusion of additional changes to the license require additional NRC staff review. This may increase the time and resources needed for the review or result in NRC staff rejection of the license amendment request (LAR). Licensees desiring significant deviations or additional changes should instead submit an LAR that does not claim to adopt TSTF-422, Revision 2.
For the Nuclear Regulatory Commission.
Pension Benefit Guaranty Corporation.
Notice of intent to request extension of OMB approval.
Pension Benefit Guaranty Corporation (“PBGC”) intends to request that the Office of Management and Budget (“OMB”) extend approval, under the Paperwork Reduction Act of 1995, of a collection of information on the disclosure of termination information under its regulations for distress terminations, 29 CFR part 4041, Subpart C, and for PBGC-initiated terminations under 29 CFR part 4042 (OMB control number 1212-0065; expires October 31, 2011). This notice informs the public of PBGC's intent and solicits public comment on the collection of information.
Comments should be submitted by June 6, 2011.
Comments may be submitted by any of the following methods:
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Copies of the collection of information may be obtained without charge by writing to the Disclosure Division of the Office of the General Counsel of PBGC at the above address, visiting the Disclosure Division, faxing a request to 202-326-4042, or calling 202-326-4040 during normal business hours. (TTY and TDD users may call the Federal relay service toll-free at 1-800-877-8339 and ask to be connected to 202-326-4040.) The regulations and instructions relating to this collection of information are available on PBGC's Web site at
Jo Amato Burns, Attorney, or Catherine B. Klion, Manager, Legislative and Regulatory Department, Pension Benefit Guaranty Corporation, 1200 K Street, NW., Washington, DC 20005, 202-326-4024. (For TTY and TDD, call 800-877-8339 and ask to be connected to 202-326-4024.)
Sections 4041 and 4042 of the Employee Retirement Income Security Act of 1974, as amended (“ERISA”), 29 U.S.C. 1301-1461, govern the termination of single-employer defined benefit pension plans that are subject to Title IV of ERISA. A plan administrator may initiate a distress termination pursuant to section 4041(c), and PBGC may itself initiate proceedings to terminate a pension plan under section 4042 if PBGC determines that certain conditions are present. Section 506 of the Pension Protection Act of 2006 (Pub. L. 109-280) amended sections 4041 and 4042 of ERISA. These amendments require that, upon a request by an affected party, a plan administrator must disclose information it has submitted to PBGC in connection with a distress termination filing, and that a plan administrator or plan sponsor must disclose information it has submitted to PBGC in connection with a PBGC-initiated termination. The provisions also require PBGC to disclose the administrative record relating to a PBGC-initiated termination upon request by an affected party. The new provisions are applicable to terminations initiated on or after August 17, 2006. On November 18, 2008 (at 73 FR 68333, PBGC amended its regulations to implement the PPA 2006 provisions.
A description of the current disclosure provisions for distress terminations can be found on PBGC's Web site at
Based on its experience and information from practitioners, PBGC estimates that three participants or other affected parties will annually make requests for termination information. PBGC estimates that the total annual burden for the collection of information will be about 45 hours and $900 (15 hours and $300 per request).
PBGC is soliciting public comments to—
• Evaluate whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
• Evaluate the accuracy of the agency's estimate of the burden of the collection of information, including the validity of the methodology and assumptions used;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934 (“Act”),