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Code · REGISTER · 2006-09-15 · Import Administration, International Trade Administration, Department of Commerce · Notices

Notices. Notice

37,130 words·~169 min read·/register/2006/09/15/06-7666·

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BILLING CODE 3510-PT-M DEPARTMENT OF COMMERCE International Trade Administration (A-427-801, A-559-801) Antifriction Bearings and Parts Thereof from France and Singapore: Revocation of Antidumping Duty Orders AGENCY: Import Administration, International Trade Administration, Department of Commerce. SUMMARY: On June 1, 2005, the Department of Commerce initiated and the International Trade Commission instituted a sunset review of the antidumping duty orders on antifriction bearings and parts thereof from France and Singapore.
As a result of the review, the International Trade Commission determined that revocation of the order on spherical plain bearings and parts thereof from France and the order on ball bearings and parts thereof from Singapore would not be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. Therefore, the Department of Commerce is revoking these two antidumping duty orders. EFFECTIVE DATE: July 11, 2005.
FOR FURTHER INFORMATION CONTACT: Edythe Artman or Minoo Hatten, Office 5, AD/CVD Operations, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street & Constitution Avenue, NW., Washington, DC 20230; telephone:
(202)482-3931 and
(202)482-1690, respectively. SUPPLEMENTARY INFORMATION: Scope of the Orders Ball Bearings and Parts Thereof The products covered by this order are ball bearings and parts thereof. These products include all bearings that employ balls as the rolling element. Imports of these products are classified under the following categories: antifriction balls, ball bearings with integral shafts, ball bearings (including radial ball bearings) and parts thereof, and housed or mounted ball bearing units and parts thereof. Imports of these products are classified under the following *Harmonized Tariff Schedule of the United States* (HTSUS) subheadings: 3926.90.45, 4016.93.00, 4016.93.10, 4016.93.50, 6909.19.5010, 8431.20.00, 8431.39.0010, 8482.10.10, 8482.10.50, 8482.80.00, 8482.91.00, 8482.99.05, 8482.99.2580, 8482.99.35, 8482.99.6595, 8483.20.40, 8483.20.80, 8483.50.8040, 8483.50.90, 8483.90.20, 8483.90.30, 8483.90.70, 8708.50.50, 8708.60.50, 8708.60.80, 8708.70.6060, 8708.70.8050, 8708.93.30, 8708.93.5000, 8708.93.6000, 8708.93.75, 8708.99.06, 8708.99.31, 8708.99.4960, 8708.99.50, 8708.99.5800, 8708.99.8080, 8803.10.00, 8803.20.00, 8803.30.00, 8803.90.30, and 8803.90.90. Although the HTSUS subheadings above are provided for convenience and customs purposes, written descriptions of the scope of this order remain dispositive. Spherical Plain Bearings, Mounted or Unmounted, and Parts Thereof: These products include all spherical plain bearings that employ a spherically shaped sliding element and include spherical plain rod ends. Imports of these products are classified under the following HTSUS subheadings: 3926.90.45, 4016.93.00, 4016.93.00, 4016.93.10, 4016.93.50, 6909.50,10, 8483.30.80, 8483.90.30, 8485.90.00, 8708.93.5000, 8708.99.50, 8803.10.00, 8803.10.00, 8803.20.00, 8803.30.00, and 8803.90.90. The HTSUS subheadings are provided for convenience and customs purposes. The written description of the scope of this order is dispositive. The size or precision grade of a bearing does not influence whether the bearing is covered by one of the orders. These orders cover all the subject bearings and parts thereof (inner race, outer race, cage, rollers, balls, seals, shields, etc.) outlined above with certain limitations. With regard to finished parts, all such parts are included in the scope of the these orders. For unfinished parts, such parts are included if
(1)they have been heat-treated, or
(2)heat treatment is not required to be performed on the part. Thus, the only unfinished parts that are not covered by these orders are those that will be subject to heat treatment after importation. The ultimate application of a bearing also does not influence whether the bearing is covered by the orders. Bearings designed for highly specialized applications are not excluded. Any of the subject bearings, regardless of whether they may ultimately be utilized in aircraft, automobiles, or other equipment, are within the scope of these orders. For a listing of scope determinations which pertain to the orders, see the “Scope Determination” Memorandum (Scope Memorandum) from the Antifriction Bearings Team to Laurie Parkhill, dated March 2, 2006. The Scope Memorandum is on file in the Central Records Unit (CRU), Main Commerce Building, Room B-099, in the General Issues record (A-100-001) for the 04/05 reviews. Background On July 11, 2000, the Department of Commerce (the Department) published the continuation of the antidumping duty orders on certain bearings and parts thereof from France and Singapore resulting from the first sunset review of these orders. See *Continuation of Antidumping Duty Orders: Certain Bearings From France, Germany, Italy, Japan, Singapore, the United Kingdom, and the People's Republic of China* , 65 FR 42665 (July 11, 2000). Pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act), and 19 CFR 351.218, the Department initiated and the International Trade Commission
(ITC)instituted the second sunset review of the order on spherical plain bearings and parts thereof from France and the order on ball bearings and parts thereof from Singapore on June 1, 2005. See *Initiation of Five-year (“Sunset”) Reviews, 70 FR 31423 (June 1, 2005); Certain Bearings From China, France, Germany, Italy, Japan, Singapore, and the United Kingdom* , 70 FR 31531 (June 1, 2005). As a result of its review, the Department found that revocation of the orders would likely lead to continuation or recurrence of dumping and notified the ITC of the magnitude of the margin likely to prevail were the orders to be revoked. See *Antifriction Bearings and Parts Thereof from France, Germany, Italy, and the United Kingdom; Five-year Sunset Reviews of Antidumping Duty Orders; Final Results* , 70 FR 58183 (October 5, 2005); *Ball Bearings and Parts Thereof from Japan and Singapore; Five-year Sunset Reviews of Antidumping Duty Orders; Final Results* , 71 FR 26321 (May 4, 2006). On August 3, 2006, the ITC determined pursuant to section 751(c) of the Act that revocation of the antidumping duty order on spherical plain bearings and parts thereof from France and the order on ball bearings and parts thereof from Singapore would not be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. See *Certain Bearings From China, France, Germany, Italy, Japan, Singapore, and the United Kingdom* , 71 FR 51850 (August 31, 2006) and ITC Publication 3876 (August 2006), entitled *Certain Bearings from China, France, Germany, Italy, Japan, Singapore, and the United Kingdom: Investigation Nos. 731-TA-344, 391-A, 392-A and C, 393-A, 394-A, 396, and 399-A (Second Review)* . Determination to Revoke As a result of the determination by the ITC that revocation of these antidumping duty orders is not likely to lead to continuation or recurrence of material injury to an industry in the United States, the Department is revoking the orders on spherical plain bearings and parts thereof from France and on ball bearings and parts thereof from Singapore, pursuant to section 751(d) of the Act. Pursuant to section 751(d)(2) of the Act and 19 CFR 351.222(i)(2)(i), the effective date of revocation is July 11, 2005 ( *i.e.* , the fifth anniversary of the date of publication in the **Federal Register** of the notice of continuation of the antidumping duty orders). The Department will notify U.S. Customs and Border Protection to discontinue suspension of liquidation and collection of cash deposits on entries of the subject merchandise entered or withdrawn from warehouse on or after July 11, 2005, the effective date of revocation of the antidumping duty orders. The Department will complete any pending administrative reviews of these orders and will conduct administrative reviews of subject merchandise entered prior to the effective date of revocation in response to appropriately filed requests for review. This five-year sunset review and notice are in accordance with section 751(d)(2) and published pursuant to section 777(I)(1) of the Act. Dated: September 7, 2006. David M. Spooner, Assistant Secretary for Import Administration. [FR Doc. E6-15356 Filed 9-14-06; 8:45 am] BILLING CODE 3510-DS-S DEPARTMENT OF COMMERCE International Trade Administration A-570-601, A-427-801, A-428-801, A-475-801, A-588-804, A-412-801 Tapered Roller Bearings and Parts Thereof from the People's Republic of China and Ball Bearings and Parts Thereof from France, Germany, Italy, Japan, and the United Kingdom: Continuation of Antidumping Duty Orders AGENCY: Import Administration, International Trade Administration, Department of Commerce. SUMMARY: As a result of the determinations by the Department of Commerce (“Department”) and the International Trade Commission (“ITC”) that revocation of the antidumping duty orders on tapered roller bearings and parts thereof from the People's Republic of China (“PRC”) and ball bearings and parts thereof from France, Germany, Italy, Japan, and the United Kingdom would be likely to lead to continuation or recurrence of dumping and of material injury to an industry in the United States, pursuant to section 751(c) of the Tariff Act of 1930, as amended (“Act”), within a reasonably foreseeable time, the Department hereby orders the continuation of these antidumping duty orders and is publishing notice of the continuation of these antidumping duty orders. EFFECTIVE DATE: September 15, 2006. FOR FURTHER INFORMATION CONTACT: Hilary E. Sadler, Esq. or Juanita Chen, Office 8 (tapered roller bearings), telephone:
(202)482-4340 or
(202)482-1904, respectively; and Edythe Artman or Minoo Hatten, Office 5 (ball bearings), telephone:
(202)482-3931 and
(202)482-1690, respectively, AD/CVD Operations, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street & Constitution Avenue, NW., Washington, DC 20230. SUPPLEMENTARY INFORMATION: Background On June 1, 2005, the Department initiated and the ITC instituted the second sunset reviews of the antidumping duty orders on tapered roller bearings and parts thereof from the PRC and ball bearings and parts thereof from France, Germany, Italy, Japan, and the United Kingdom pursuant to section 751(c) of the Act. *See Initiation of Five-Year (“Sunset”) Reviews* , 70 FR 31423 (June 1, 2005), and *Certain Bearings From China, France, Germany, Italy, Japan, Singapore, and the United Kingdom* , 70 FR 31531 (June 1, 2005). As a result of its reviews, the Department found that revocation of the antidumping duty orders would be likely to lead to continuation or recurrence of dumping and notified the ITC of the magnitude of the margins likely to prevail were the orders to be revoked. *See Tapered Roller Bearings from the People's Republic of China: Notice of Final Results of Expedited Sunset Review of Antidumping Duty Order* , 70 FR 58383 (October 6, 2005), *Antifriction Bearings and Parts Thereof from France, Germany, Italy, and the United Kingdom; Five-Year Sunset Reviews of Antidumping Duty Orders; Final Results* , 70 FR 58183 (October 5, 2005), *Ball Bearings and Parts Thereof from Japan and Singapore; Five-year Sunset Reviews of Antidumping Duty Orders; Final Results* , 71 FR 26321 (May 4, 2006), and *Ball Bearings and Parts Thereof from Japan; Five-year Sunset Review of Antidumping Duty Order; Amended Final Results* , 71 FR 30378 (May 26, 2006). On August 3, 2006, the ITC determined, pursuant to section 751(c) of the Act, that revocation of the antidumping duty orders on tapered roller bearings and parts thereof from the PRC and ball bearings and parts thereof from France, Germany, Italy, Japan, and the United Kingdom would be likely to lead to continuation or recurrence of material injury to an industry in the United States within a reasonably foreseeable time. *See Certain Bearings From China, France, Germany, Italy, Japan, Singapore, and the United Kingdom* , 71 FR 51850 (August 31, 2006), and ITC Publication 3876 (August 2006) (Investigation Nos. 731-TA-344, 391-A, 392-A and C, 393-A, 394-A, 396, and 399-A (Second Review)). Scope of the Orders *Tapered Roller Bearings* : Imports covered by this order are shipments of tapered roller bearings and parts thereof, finished and unfinished, from the PRC; flange, take up cartridge, and hanger units incorporating tapered roller bearings; and tapered roller housings (except pillow blocks) incorporating tapered rollers, with or without spindles, whether or not for automotive use. These products are currently classifiable under Harmonized Tariff Schedule of the United States (“HTSUS”) item numbers 8482.20.00, 8482.91.00.50, 8482.99.30, 8483.20.40, 8483.20.80, 8483.30.80, 8483.90.20, 8483.90.30, 8483.90.80, 8708.99.80.15 and 8708.99.80.80. Although the HTSUS item numbers are provided for convenience and customs purposes, the written description of the scope of the order is dispositive. *Ball Bearings* : The products covered by these orders are ball bearings and parts thereof. These products include all bearings that employ balls as the rolling element. Imports of these products are classified under the following categories: antifriction balls, ball bearings with integral shafts, ball bearings (including radial ball bearings) and parts thereof, and housed or mounted ball bearing units and parts thereof. Imports of these products are classified under the following HTSUS subheadings: 3926.90.45, 4016.93.00, 4016.93.10, 4016.93.50, 6909.19.5010, 8431.20.00, 8431.39.0010, 8482.10.10, 8482.10.50, 8482.80.00, 8482.91.00, 8482.99.05, 8482.99.2580, 8482.99.35, 8482.99.6595, 8483.20.40, 8483.20.80, 8483.50.8040, 8483.50.90, 8483.90.20, 8483.90.30, 8483.90.70, 8708.50.50, 8708.60.50, 8708.60.80, 8708.70.6060, 8708.70.8050, 8708.93.30, 8708.93.5000, 8708.93.6000, 8708.93.75, 8708.99.06, 8708.99.31, 8708.99.4960, 8708.99.50, 8708.99.5800, 8708.99.8080, 8803.10.00, 8803.20.00, 8803.30.00, 8803.90.30, and 8803.90.90. Although the HTSUS subheadings above are provided for convenience and customs purposes, written descriptions of the scope of these orders remain dispositive. The size or precision grade of a bearing does not influence whether the bearing is covered by one of the orders. These orders cover all the subject bearings and parts thereof (inner race, outer race, cage, rollers, balls, seals, shields, etc.) outlined above with certain limitations. With regard to finished parts, all such parts are included in the scope of the these orders. For unfinished parts, such parts are included if
(1)they have been heat-treated, or
(2)heat treatment is not required to be performed on the part. Thus, the only unfinished parts that are not covered by these orders are those that will be subject to heat treatment after importation. The ultimate application of a bearing also does not influence whether the bearing is covered by the orders. Bearings designed for highly specialized applications are not excluded. Any of the subject bearings, regardless of whether they may ultimately be utilized in aircraft, automobiles, or other equipment, are within the scope of these orders. For a listing of scope determinations that pertain to the ball bearings orders, see the “Scope Determination” Memorandum (“Scope Memorandum”) from the Antifriction Bearings Team to Laurie Parkhill, dated March 2, 2006. The Scope Memorandum is on file in the Central Records Unit, Main Commerce Building, Room B-099, in the General Issues record (A-100-001) for the 2004/2005 reviews. Determination As a result of the determinations by the Department and ITC that revocation of these antidumping duty orders would be likely to lead to continuation or recurrence of dumping and material injury to an industry in the United States, pursuant to sections 751(d)(2)(A) and
(B)of the Act, the Department hereby orders the continuation of the antidumping duty orders on tapered roller bearings and parts thereof from the PRC and ball bearings and parts thereof from France, Germany, Italy, Japan, and the United Kingdom. U.S. Customs and Border Protection will continue to collect antidumping duty cash deposits at the rates in effect at the time of entry for all imports of subject merchandise. The effective date of continuation of these orders will be the date of publication in the **Federal Register** of this notice of continuation. Pursuant to sections 751(c)(2) and 751(c)(6) of the Act, the Department intends to initiate the next five-year reviews of these orders not later than July 2011. These sunset reviews and this continuation notice are in accordance with section 751(c) of the Act and are published pursuant to section 777(i)(1) of the Act. Dated: September 7, 2006. David M. Spooner, Assistant Secretary for Import Administration. [FR Doc. E6-15355 Filed 9-14-06; 8:45 am] Billing Code: 3510-DS-S DEPARTMENT OF COMMERCE International Trade Administration A-588-857 Preliminary Results of the Antidumping Duty Changed Circumstances Review and Notice of Intent to Revoke the Order in Part: Certain Welded Large Diameter Line Pipe from Japan AGENCY: Import Administration, International Trade Administration, Department of Commerce. SUMMARY: On August 14, 2006, the Department of Commerce (“the Department”) published a notice of initiation of a changed circumstances review of the antidumping duty order on welded large diameter line pipe (“LDLP”) from Japan with respect to excluding certain LDLP as described below from the order. *See Initiation of Antidumping Duty Changed Circumstances Review: Certain Welded Large Diameter Line Pipe From Japan* , 71 FR 46448 (August 14, 2006), (“ *Notice of Initiation* ”). In our *Notice of Initiation* , we invited parties to comment on the request to exclude certain LDLP (“product in question”), as described below. The Department received no comments. Absent any comments, the Department preliminarily concludes that producers accounting for substantially all of the production of the domestic like product to which this order pertains lack interest in the relief provided by this order with respect to the product in question. Therefore, the Department preliminarily concludes that it is appropriate to revoke this order, in part, with respect to all future entries for consumption of certain welded LDLP, as described below, which would become effective on the date of publication of the final results of this review. EFFECTIVE DATE: September 15, 2006. FOR FURTHER INFORMATION CONTACT: Judy Lao or Abdelali Elouaradia, AD/CVD Operations, Office 7, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW, Washington, DC 20230; telephone:
(202)482-7924 and
(202)482-1374, respectively. The Applicable Statute and Regulations Unless otherwise indicated, all citations to the statute are references to the provisions effective January 1, 1995, the effective date of the amendments made to the Tariff Act of 1930, as amended (“the Act”), by the Uruguay Round Agreements Act. In addition, unless otherwise indicated, all citations to the Department's regulations are to the regulations as codified at 19 C.F.R. Part 351 (2002). SUPPLEMENTARY INFORMATION: Background On December 6, 2001, the Department published in the **Federal Register** the antidumping duty order on certain welded large diameter line pipe from Japan. *See Notice of Antidumping Duty Order: Certain Welded Large Diamter Line Pipe from Japan* , 66 FR 63368 (December 6, 2001); *see also Certain Welded Large Diameter Line Pipe From Japan: Final Results of Changed Circumstances Review* , 67 FR 64870 (October 22, 2002), which revoked the order with respect to certain merchandise as described in the “Scope of the Order” section of this notice. On July 17, 2006, American Steel Pipe Division of the American Cast Iron Company, Berg Steel Pipe, and Stupp Corporation, (collectively, “petitioners”) requested a changed circumstances review indicating they no longer have an interest in the following product being subject to the order: API grade X-80 having an outside diameter of 21 inches and wall thickness of 0.625 or more inches. *See* Letter from Petitioners to the Department, regarding large diameter welded line pipe from Japan, (July 17, 2006). In response to the request made by petitioners, the Department published the *Notice of Initiation* on August 14, 2006. In the notice, we indicated that interested parties could submit comments for consideration in the Department's preliminary results. We did not receive any comments from interested parties. Scope of the Order The product covered by this antidumping order is certain welded carbon and alloy line pipe, of circular cross section and with an outside diameter greater than 16 inches, but less than 64 inches, in diameter, whether or not stenciled. This product is normally produced according to American Petroleum Institute
(API)specifications, including Grades A25, A, B, and X grades ranging from X42 to X80, but can also be produced to other specifications. The product currently is classified under U.S. Harmonized Tariff Schedule (HTSUS) item numbers 7305.11.10.30, 7305.11.10.60, 7305.11.50.00, 7305.12.10.30, 7305.12.10.60, 7305.12.50.00, 7305.19.10.30. 7305.19.10.60, and 7305.19.50.00. Although the HTSUS item numbers are provided for convenience and customs purposes, the written description of the scope is dispositive. Specifically not included within the scope of this order is American Water Works Association
(AWWA)specification water and sewage pipe and the following size/grade combinations; of line pipe: -Having an outside diameter greater than or equal to 18 inches and less than or equal to 22 inches, with a wall thickness measuring 0.750 inch or greater, regardless of grade. -Having an outside diameter greater than or equal to 24 inches and less than 30 inches, with wall thickness measuring greater than 0.875 inches in grades A, B, and X42, with wall thickness measuring greater than 0.750 inches in grades X52 through X56, and with wall thickness measuring greater than 0.688 inches in grades X60 or greater. -Having an outside diameter greater than or equal to 30 inches and less than 36 inches, with wall thickness measuring greater than 1.250 inches in grades A, B, and X42, with wall thickness measuring greater than 1.000 inches in grades X52 through X56, and with wall thickness measuring greater than 0.875 inches in grades X60 or greater. -Having an outside diameter greater than or equal to 36 inches and less than 42 inches, with wall thickness measuring greater than 1.375 inches in grades A, B, and X42, with wall thickness measuring greater than 1.250 inches in grades X52 through X56, and with wall thickness measuring greater than 1.125 inches in grades X60 or greater. -Having an outside diameter greater than or equal to 42 inches and less than 64 inches, with a wall thickness measuring greater than 1.500 inches in grades A, B, and X42, with wall thickness measuring greater than 1.375 inches in grades X52 through X56, and with wall thickness measuring greater than 1.250 inches in grades X60 or greater. -Having an outside diameter equal to 48 inches, with a wall thickness measuring 1.0 inch or greater, in grades X-80 or greater. -Having an outside diameter of 48 inches to and including 52 inches, and with a wall thickness of 0.90 inch or more in grade X-80 -Having an outsides diameter of 48 inches to and including 52 inches, and with a wall thickness of 0.54 inch or more in grade X100. Scope of Changed Circumstances Review The products subject to this changed circumstances review are LDLP from Japan with an API grade X-80 having an outside diameter of 21 inches and wall thickness of 0.625 or more inches. Preliminary Results of Review and Intent to Revoke in Part the Antidumping Duty Order Pursuant to section 751(d)(1) of the Act, the Department may revoke an antidumping or countervailing duty order, in whole or in part, based on a review under section 751(b) of the Act ( *i.e.* , a changed circumstances review). Section 751(b)(1) of the Act requires a changed circumstances review to be conducted upon receipt of a request which shows changed circumstances sufficient to warrant a review. Section 351.222(g)(1) of the Department's regulations provides that the Department may revoke an order (in whole or in part) based on changed circumstances, if it determines that:
(i)producers accounting for substantially all of the production of the domestic like product to which the order (or part of the order to be revoked) pertains have expressed a lack of interest in the relief provided by the order, in whole or in part, or
(ii)other changed circumstances are sufficient to warrant revocation exist. Taking into consideration that
(1)the petitioners have uniformly expressed that they do not want relief with respect to this particular product, and that
(2)there have been no contrary expressions from the remainder of the known LDLP producers, we are notifying the public of our intent to revoke, in part, certain welded large diameter line pipe from Japan. Interested parties wishing to comment on these preliminary results may submit briefs to the Department no later than 15 days after the publication of this notice in the **Federal Register** . Parties will have 7 days subsequent to this due date to submit rebuttal comments, limited to the issues raised in those briefs. Parties who submit briefs or rebuttal comments in this proceeding are requested to submit with each argument
(1)a statement of the issue and
(2)a brief summary of the argument (no longer than five pages, including footnotes). Any requests for hearing must be filed within 30 days of the publication of this notice in the **Federal Register** . All written comments must be submitted in accordance with 19 CFR 351.303, with the exception that only three
(3)copies for each case need be served on the Department. Any comments must also be served on all interested parties on the Department's service list, which is available on our website (http://ia.ita.doc.gov/apo/index.html). The Department will issue its final results in this changed circumstances review as soon as practicable following the above comment period, but not later than 270 days after the date on which the changed circumstances review was initiated, in accordance with 19 CFR 351.216(e), and will publish the results in the **Federal Register** . If the final partial revocation occurs, the Department will instruct U.S. Customs and Border Protection to discontinue the suspension of liquidation for all future entries of merchandise covered by the revocation, and to release any cash deposits or bonds pursuant to 19 CFR 351.222(g)(4). The current requirement for a cash deposit of estimated antidumping duties on all subject merchandise will continue unless and until it is modified pursuant to the final results of this changed circumstances review. This notice is published in accordance with sections 751(b)(1) and 777(i)(1) of the Act and 19 CFR 351.216 and 351.222. Dated: September 11, 2006. David M. Spooner, Assistant Secretary for Import Administration. [FR Doc. E6-15357 Filed 9-14-06; 8:45 am] BILLING CODE 3510-DS-S DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration Correction; Steller Sea Lion Protection Economic Survey ACTION: Notice. The National Oceanic and Atmospheric Administration, National Marine Fisheries Service is issuing a correction and clarification of a **Federal Register** notice (71 FR 47177) announcing plans to conduct a survey regarding public preferences for potential results of protection measures on Steller sea lion populations. The following Abstract replaces the one in the aforementioned notice: I. Abstract The Steller sea lion is a listed species under the Endangered Species Act of 1973 (16 U.S.C. 35). The public benefits associated with the results of protection actions on the endangered Western and threatened Eastern stocks of Steller sea lions ( *Eumetopias jubatus* ), such as population increases, are primarily the result of the non-consumptive value people attribute to such protection (e.g., active use values associated with being able to view Steller sea lions and passive use values unrelated to direct human use). Little is known about these values, yet such information is needed for decision makers to more fully understand the trade-offs involved in choosing among protection alternatives and to complement other information available about the costs, benefits, and impacts of the protection alternatives. The National Marine Fisheries Service
(NMFS)plans to conduct a survey of U.S. citizens, presenting information on Steller sea lions, including information about population trends and current management actions and asking respondents for information regarding their knowledge of and opinions regarding: Steller sea lions, other marine mammals and endangered species, and potential Steller sea lion population increases and changes in listing status that might result from management. The standard socio-demographic information needed to classify respondents will also be collected. The survey will gather a sufficient number of responses to estimate the non-consumptive benefits associated with the results of protection actions on Steller sea lions. This information is currently unavailable, and would be used by analysts to supplement existing information available for the evaluation of Steller sea lion protection alternatives.” FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to Dr. Dan Lew, National Marine Fisheries Service, Alaska Fisheries Science Center, 7600 Sand Point Way, NE., Seattle, WA 98115; Telephone:
(206)526-4252; Fax:
(206)526-6723; e-mail: *dan.lew@noaa.gov.* Dated: September 11, 2006. Gwellnar Banks, Management Analyst, Office of the Chief Information Officer. [FR Doc. E6-15305 Filed 9-14-06; 8:45 am] BILLING CODE 3510-22-P DEPARTMENT OF COMMERCE National Oceanic and Atmospheric Administration [I.D. 083006C] Vessel Monitoring Systems; Approved Mobile Transmitting Units for use in the Reef Fish Fishery of the Gulf of Mexico AGENCY: National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce. ACTION: Notice of vessel monitoring systems; type-approval. SUMMARY: This document provides notice of vessel monitoring systems
(VMS)approved by NOAA for use by vessels participating in the Reef Fish Fishery of the Gulf of Mexico and sets forth relevant features of the VMS. ADDRESSES: To obtain copies of the list of NOAA-approved VMS mobile transmitting units and NOAA-approved VMS communications service providers, please contact the VMS Support Center at phone 888-219-9228, fax 301-427-0049, or write to NOAA Fisheries Office for Law Enforcement (OLE), VMS Support Center, 8484 Georgia Avenue, Suite 415, Silver Spring, MD 20910. For more addresses regarding approved VMS, see the SUPPLEMENTARY INFORMATION section, under the heading VMS Provider Addresses. FOR FURTHER INFORMATION CONTACT: For questions regarding the status of VMS provider evaluations, contact Jonathan Pinkerton, National VMS Program Manager, phone 301-427-2300; fax 301-427-0049. For questions regarding the Reef Fish Fishery of the Gulf of Mexico VMS requirement, contact Beverly Lambert, Southeast Divisional VMS Program Manager, NMFS Office for Law Enforcement, Southeast Division, phone 727-824-5344. SUPPLEMENTARY INFORMATION: I. VMS Mobile Transceiver Units A. BOATRACS - FMTC/G The Boatracs satellite communications VMS transmitting unit that meets the minimum technical requirements for the Reef Fish Fishery is the BOATRACS - FMTC/G. The address for the Boatracs distributor dealer contact is provided in this notice under the heading “VMS Provider Addresses.” The FMTC/G is an integrated Global Positioning System
(GPS)two-way satellite communications system, consisting of two major hardware components, the Mobile Communication Transceiver
(MCT)and the Enhanced Display Unit (EDU). The MCT contains the antenna and integrated GPS that communicates with the satellite and contains the operating circuitry and memory. The EDU is a shock and splash resistant display and keyboard unit consisting of a liquid crystal display, keyboard, with adjustable contrast and brightness, and audible alerts. A backlight illuminates the display for night view. The EDU has message waiting, no signal, and audible message received indicators. The MCT is 6.7 inches high, 11.4 inches wide and weighs 11 pounds. The base of the unit is 6.595 inches in diameter. The transceiver draws approximately 2.3 amps of current from the power supply while transmitting and 1.2 amps when the vessel is idle. The EDU is a hardened and splash proof keyboard display unit with a 15-line X 40-character screen that allows for both text and graphics. It is 12.72 inches wide, 9.3 inches long, 2.21 inches in depth, and weighs 3 pounds and is holster-mounted in the cabin. A vessel owner may purchase this system by contacting the entity identified in this notice under the heading “VMS Provider Address.” The owner should identify him or herself as a vessel owner issued a permit to operate in the Reef Fish Fishery of the Gulf of Mexico, so the transceiver set can be properly configured. B. Thrane & Thrane Sailor 3026D Gold VMS The Thrane & Thrane Sailor 3026D Gold VMS(TT-3026D) meets the minimum technical requirements for vessels issued permits to operate in the Reef Fish Fishery of the Gulf of Mexico. The address for the Thrane & Thrane distributor contact is provided in this notice under the heading “VMS Provider Addresses.” The TT-3026D features an integrated GPS/Inmarsat-C unit and a marine grade monitor with keyboard and integrated mouse. The unit is factory pre-configured for NMFS VMS operations (non-Global Maritime Distress & Safety System). Satellite commissioning services are provided by Thrane & Thrane personnel. Automatic GPS position reporting starts after transceiver installation and power activation onboard the vessel. The unit is an integrated transceiver/antenna/GPS design using a floating 10 to 32 VDC power supply. The unit is configured for automatic reduced position transmissions when the vessel is stationary (i.e., in port). It allows for port stays without power drain or power shut down. The unit restarts normal position transmission automatically when the vessel goes to sea. The TT-3026D provides operation down to 15 degree angles. The unit has the capability of two-way communications to send formatted forms and to receive e-mail and other messages. A configuration option is available to automatically send position reports to a private address, such as a fleet management company. A vessel owner may purchase this system by contacting the entity identified in this notice under the heading “VMS Provider Addresses.” The owner should identify him or herself as a vessel owner issued a permit to operate in the Reef Fish Fishery of the Gulf of Mexico, so the transceiver set can be properly configured. To use the TT-3026D the vessel owner will need to establish an Inmarsat-C system use contract with an approved Inmarsat-C communications service provider. The owner will be required to complete the Inmarsat-C “Registration for Service Activation for Maritime Mobile Earth Station.” The owner should consult with Thrane & Thrane when completing this form. Thrane & Thrane personnel will perform the following services before shipment:
(1)configure the transceiver according to OLE specifications for vessels issued permits to operate in the Reef Fish Fishery of the Gulf of Mexico;
(2)download the predetermined NMFS position reporting and broadcast command identification numbers into the unit;
(3)test the unit to ensure operation when installation has been completed on the vessel; and
(4)forward the Inmarsat service provider and the transceiver identifying information to OLE. II. Satellite Communication Services A. Boatracs The FMTC/G utilizes a KU band geostationary satellite to provide two-way date services. The satellite transmits and receives all two-way message traffic between the vessel and NMFS, Shore Office, NOC or third party. The satellite is located 22,300 miles over the equator at 103° W Longitude (south of Florida). Boatracs operates a redundant Network Operations Center (NOC). This facility is online 24 hours a day, 365 days a year, including holidays. Customer service representatives are available to relay messages and provide customer service. The NOC is also the facility that allows for automatic boat-to-boat, boat-to-e-mail, boat-to-fax, and e-mail-to-boat service. Data on demand and information services are also provided by the NOC. Boatracs contracts their satellite communication services from QUALCOMM Corporation of California. QUALCOMM offers 24x7, 365 days a year network support, and operates fully redundant earth stations in California and Nevada. VMS units must be installed in accordance with vendor instructions and specifications. All installation costs are paid by the owner. The vessel owner is required to fax the Reef Fish Fishery Activation Fax directly to VMS Support Center at 301-427-0049(fax), or mail to NOAA Fisheries Office for Law Enforcement (OLE), VMS Support Center, 8484 Georgia Avenue, Suite 415, Silver Spring, MD 20910. The owner must confirm the FMTC/G operation and communications service to ensure that position reports are automatically sent to and received by OLE before leaving on their first fishing trip requiring VMS. OLE does not regard the fishing vessel as meeting the requirements until position reports are automatically received. For confirmation purposes, owners must contact the VMS Support Center, phone 888-219-9228, fax 301-427-0049. B. Inmarsat C Telenor Satellite Services Inmarsat-C is a store-and-forward data messaging service. Inmarsat-C allows users to send and receive information virtually anywhere in the world, on land, at sea, and in the air. Inmarsat-C supports a wide variety of applications including Internet, e-mail, position and weather reporting, a free daily news service, and remote equipment monitoring and control. Mariners can use Inmarsat-C free of charge to send critical safety at sea messages as part of the U.S. Coast Guard's Automated Mutual-Assistance Vessel Rescue system and of the NOAA Shipboard Environmental Acquisition System programs. Telenor Vessel Monitoring System Services is being sold through Thrane & Thrane, Inc. For the Thrane & Thrane and Telenor addresses, look inside this notice under the heading “VMS Provider Addresses.” Xantic Xantic is a provider of Vessel Monitoring Services to the maritime industry. By installing an approved OLE Inmarsat-C transceiver on the vessel, vessels can send and receive e-mail, to and from land, while the transceiver automatically sends vessel position reports to OLE, and is fully compliant with the International Coast Guard Search and Rescue Centers. Xantic Vessel Monitoring System Services are being sold through Thrane & Thrane, Inc. For the Thrane & Thrane and Xantic addresses, look in this notice under the heading “VMS Provider Addresses.” For Telenor and Xantic, Thrane & Thrane customer service supports the security and privacy of vessel accounts and messages with the following:
(a)password authentication for vessel owners or agents and for OLE to prevent unauthorized changes or inquiries; and
(b)separation of private messages from OLE messages. (OLE requires VMS-related position reports, only.) Billing is separated between accounts for the vessel owner and the OLE. VMS position reports and vessel-initiated messaging are paid for by the vessel owner. Messaging initiated from OLE operations center is paid for by NOAA. Thrane & Thrane provides customer service for Telenor and Xantic users to support and establish two-way transmission of transceiver unit configuration commands between the transceiver and land-based control centers. This supports OLE's message needs, and optionally, the crew's private message needs. The vessel owner can configure automatic position reports to be sent to a private address, such as to a fleet management company. Vessel owners wishing to use Telenor or Xantic services will need to purchase an Inmarsat-C transceiver approved for vessels issued permits to operate in the Reef Fish Fishery of the Gulf of Mexico. The owner will need to complete an Inmarsat-C system use contract with Telenor or Xantic, including a mobile earth station license (FCC requirement). The transceiver will need to be commissioned with Inmarsat according to Telenor or Xantic's instructions. The owner should refer to and follow the configuration, installation, and service activation procedures for the specific transceiver purchased. The owner must confirm the TT-3026D operation and communications service to ensure that position reports are automatically sent to and received by OLE before leaving on their first fishing trip requiring VMS. OLE does not regard the fishing vessel as meeting the requirements until position reports are automatically received. For confirmation purposes, owners must contact the VMS Support Center, phone 888-219-9228, fax 301-427-0049. III. VMS Provider Addresses Boatracs corporate office address is 9155 Brown Deer Rd, Suite 8, San Diego, CA 92121. Telephone numbers are toll free
(877)468-8722 and direct dialed (858)458-8100. The primary point of contact is Debbie Foste, Fisheries Market Segment Executive, e-mail *dfoste@boatracs.com* , direct telephone number (858)458-8105. The alternate contact is Winston Richardson, e-mail *wrichardson@boatracs.com* , direct telephone number (858)458-8106. For Thrane & Thrane Sailor 3026D Gold VMS, Telenor, or Xantic information contact Lauri Paul, Marine Products, Thrane & Thrane, Inc., 509 Viking Drive, Suite K, L & M, Virginia Beach, VA 23452; voice: 757-753-9450 or 757-463-9557; fax: 757-463-9581, e-mail: *lp@thrane.com* ; Web site: *http://www.us.thrane.com/* . Dated: September 11, 2006. William T. Hogarth, Assistant Administrator for Fisheries, National Marine Fisheries Service. [FR Doc. E6-15340 Filed 9-14-06; 8:45 am] BILLING CODE 3510-22-S DEPARTMENT OF COMMERCE National Telecommunications and Information Administration Docket No.: [060606155-6237-02] Privacy Act of 1974: System of Records AGENCY: National Telecommunications and Information Administration, U.S. Department of Commerce. ACTION: Final Notice to delete a Privacy Act System of Records: COMMERCE/NTIA-1, “Radio Spectrum Management Career Development Program.” SUMMARY: The National Telecommunications and Information Administration
(NTIA)publishes this notice to announce the deletion of a Privacy Act System of Records entitled COMMERCE/NTIA-1, “Radio Spectrum Management Career Development Program.” NTIA no longer collects or maintains this system of records. DATES: The system of records will be deleted on September 15, 2006. FOR FURTHER INFORMATION CONTACT: Stacy Cheney, Attorney-Advisor, Office of the Chief Counsel, National Telecommunications and Information Administration, Room 4713, 14th Street and Constitution Avenue, NW., Washington, DC 20231. SUPPLEMENTARY INFORMATION: On June 20, 2006, NTIA published a notice in the Federal Register requesting comments on the deletion of a Privacy Act System of Records entitled COMMERCE/NTIA-1, “Radio Spectrum Management Career Development Program.” NTIA no longer collects or maintains this system of records. No comments were received in response to the request for comments. By this notice, NTIA is deleting this system of records on September 15, 2006. Dated: September 7, 2006. Brenda Dolan, Freedom of Information and Privacy Act Officer, Department of Commerce. [FR Doc. E6-15185 Filed 9-14-06; 8:45 am] BILLING CODE 3510-60-S DEPARTMENT OF EDUCATION Notice of Proposed Information Collection Requests AGENCY: Department of Education. SUMMARY: The IC Clearance Official, Regulatory Information Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995. DATES: Interested persons are invited to submit comments on or before November 14, 2006. SUPPLEMENTARY INFORMATION: Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget
(OMB)provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The IC Clearance Official, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following:
(1)Type of review requested, e.g. new, revision, extension, existing or reinstatement;
(2)Title;
(3)Summary of the collection;
(4)Description of the need for, and proposed use of, the information;
(5)Respondents and frequency of collection; and
(6)Reporting and/or Recordkeeping burden. OMB invites public comment. 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. Dated: September 11, 2006. Angela C. Arrington, IC Clearance Official, Regulatory Information Management Services, Office of Management. Office of Elementary and Secondary Education *Type of Review:* Revision. *Title:* Mathematics and Science Partnerships Program: Annual Performance Report. *Frequency:* Annually. *Affected Public:* State, Local, or Tribal Gov't, SEAs or LEAs; Businesses or other for-profit; Not-for-profit institutions; Federal Government. *Reporting and Recordkeeping Hour Burden:* * Responses:* 600. * Burden Hours:* 8,400. *Abstract:* The Mathematics and Science Partnerships program is a formula grant program to the States in which states make competitive awards to projects. Legislation requires all locally funded projects to report annually to the Secretary documenting progress towards goals and objectives. The Annual Performance Report, an online reporting tool, will provide projects an opportunity to describe partnerships, report on the impact of the projects, share effective professional development strategies, and help ED program officials to examine outcomes across multiple projects. Requests for copies of the proposed information collection request may be accessed from *http://edicsweb.ed.gov* , by selecting the “Browse Pending Collections” link and by clicking on link number 3173. When you access the information collection, click on “Download Attachments” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., Potomac Center, 9th Floor, Washington, DC 20202-4700. Requests may also be electronically mailed to *ICDocketMgr@ed.gov* or faxed to 202-245-6623. Please specify the complete title of the information collection when making your request. Comments regarding burden and/or the collection activity requirements should be electronically mailed to *ICDocketMgr@ed.gov.* Individuals who use a telecommunications device for the deaf
(TDD)may call the Federal Information Relay Service
(FIRS)at 1-800-877-8339. [FR Doc. E6-15288 Filed 9-14-06; 8:45 am] BILLING CODE 4000-01-P DEPARTMENT OF EDUCATION Notice of Proposed Information Collection Requests AGENCY: Department of Education. SUMMARY: The IC Clearance Official, Regulatory Information Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995. DATES: Interested persons are invited to submit comments on or before November 14, 2006. SUPPLEMENTARY INFORMATION: Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget
(OMB)provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The IC Clearance Official, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following:
(1)Type of review requested, e.g. new, revision, extension, existing or reinstatement;
(2)Title;
(3)Summary of the collection;
(4)Description of the need for, and proposed use of, the information;
(5)Respondents and frequency of collection; and
(6)Reporting and/or Recordkeeping burden. OMB invites public comment. 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. Dated: September 11, 2006. Angela C. Arrington, IC Clearance Official, Regulatory Information Management Services, Office of Management. Office of Safe and Drug Free Schools *Type of Review:* Extension. *Title:* Gun-Free Schools Act Report. *Frequency:* Annually. *Affected Public:* State, Local, or Tribal Gov't, SEAs or LEAs. *Reporting and Recordkeeping Hour Burden:* * Responses:* 7,221. * Burden Hours:* 14,756. *Abstract:* The Gun-Free Schools Act
(GFSA)requires each State to provide annual reports to the Secretary concerning implementation of the Act's requirements regarding expulsions from schools resulting from firearms violations. The GFSA requires each State receiving ESEA funds to have in effect a State law requiring LEAs to expel from school for a period of not less than one year a student found to have brought a firearm to school or to have possessed a firearm at school. The GFSA also requires LEAs that receive ESEA funds to adopt a policy requiring referral to the criminal justice or juvenile delinquency system of any student who brings a firearm to school or possesses a firearm at school. Requests for copies of the proposed information collection request may be accessed from *http://edicsweb.ed.gov* , by selecting the “Browse Pending Collections” link and by clicking on link number 3181. When you access the information collection, click on “Download Attachments” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., Potomac Center, 9th Floor, Washington, DC 20202-4700. Requests may also be electronically mailed to *ICDocketMgr@ed.gov* or faxed to 202-245-6623. Please specify the complete title of the information collection when making your request. Comments regarding burden and/or the collection activity requirements should be electronically mailed to *ICDocketMgr@ed.gov.* Individuals who use a telecommunications device for the deaf
(TDD)may call the Federal Information Relay Service
(FIRS)at 1-800-877-8339. [FR Doc. E6-15289 Filed 9-14-06; 8:45 am] BILLING CODE 4000-01-P DEPARTMENT OF EDUCATION Notice of Proposed Information Collection Requests AGENCY: Department of Education. SUMMARY: The IC Clearance Official, Regulatory Information Management Services, Office of Management, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995. DATES: Interested persons are invited to submit comments on or before November 14, 2006. SUPPLEMENTARY INFORMATION: Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget
(OMB)provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The IC Clearance Official, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following:
(1)Type of review requested, e.g., new, revision, extension, existing or reinstatement;
(2)Title;
(3)Summary of the collection;
(4)Description of the need for, and proposed use of, the information;
(5)Respondents and frequency of collection; and
(6)Reporting and/or Recordkeeping burden. OMB invites public comment. 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. Dated: September 11, 2006. Angela C. Arrington, IC Clearance Official, Regulatory Information Management Services, Office of Management. Office of Safe and Drug Free Schools *Type of Review:* Extension. *Title:* Grants to States for Training Incarcerated Youth Offenders Application, Annual Report, and Eligible Population Data Request Form. *Frequency:* Annually. *Affected Public:* State, Local, or Tribal Gov't, SEAs or LEAs. *Reporting and Recordkeeping Hour Burden:* *Responses:* 56. *Burden Hours:* 2,147. *Abstract:* To receive an award under the Grants to States for Training Incarcerated Youth Offenders programs, State Correctional Education Agencies
(SCEA)must submit an application that includes a state plan describing how the program will operate. In addition, states must also submit an Eligible Population Data Request Form is necessary to run the annual allocation formula and an evaluation report. The latter two collections must be submitted each of the three grant years. Requests for copies of the proposed information collection request may be accessed from *http://edicsweb.ed.gov* , by selecting the “Browse Pending Collections” link and by clicking on link number 3176. When you access the information collection, click on “Download Attachments” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., Potomac Center, 9th Floor, Washington, DC 20202-4700. Requests may also be electronically mailed to *ICDocketMgr@ed.gov* or faxed to 202-245-6623. Please specify the complete title of the information collection when making your request. Comments regarding burden and/or the collection activity requirements should be electronically mailed to *ICDocketMgr@ed.gov.* Individuals who use a telecommunications device for the deaf
(TDD)may call the Federal Information Relay Service
(FIRS)at 1-800-877-8339. [FR Doc. E6-15290 Filed 9-14-06; 8:45 am] BILLING CODE 4000-01-P DEPARTMENT OF EDUCATION Notice of Proposed Information Collection Requests AGENCY: Department of Education. ACTION: Correction notice. SUMMARY: On August 30, 2006, the Department of Education published a notice in the **Federal Register** (Page 51587, Column 1) for the information collection, “The IEPS Reporting System
(NRC)Program Which Includes the Performance Reports for 14 Programs—the FLAS Program, IIPP Program, UISFL Program, BIE Program, CIBE Program, AORC Program, LRC Program, IRS Program, FRA Program, DDRA Program, SA Program, GPA Program, and TICFIA Program.” This notice hereby corrects the title to “The IEPS Reporting System Which Includes the Performance Reports for 14 Programs—the NRC Program, the FLAS Program, IIPP Program, UISFL Program, BIE Program, CIBE Program, AORC Program, FRA Program, DDRA Program, SA Program, GPA Program, and TICFIA Program.” The IC Clearance Official, Regulatory Information Management Services, Office of the Chief Information Officer, hereby issues a correction notice as required by the Paperwork Reduction Act of 1995. Dated: September 11, 2006. Angela C. Arrington, IC Clearance Official, Regulatory Information Management Services, Office of the Management. [FR Doc. E6-15291 Filed 9-14-06; 8:45 am] BILLING CODE 4000-01-P DEPARTMENT OF ENERGY Energy Information Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Energy Information Administration (EIA), Department of Energy (DOE). ACTION: Agency information collection activities: submission for OMB review; comment request. SUMMARY: The EIA has submitted the Form EIA-902, “Annual Geothermal Heat Pump Manufacturers Survey” to the Office of Management and Budget
(OMB)for review and a 14-month extension under section 3507(h)(1) of the Paperwork Reduction Act of 1995 (Pub. L. 104-13) (44 U.S.C. 3501 et seq., at 3507(h)(1)). DATES: Comments must be filed by October 16, 2006. If you anticipate that you will be submitting comments but find it difficult to do so within that period, you should contact the OMB Desk Officer for DOE listed below as soon as possible. ADDRESSES: Send comments to John Asalone, OMB Desk Officer for DOE, Office of Information and Regulatory Affairs, Office of Management and Budget. To ensure receipt of the comments by the due date, submission by FAX at 202-395-7285 or e-mail to * John_A._Asalone@omb.eop.gov* is recommended. The mailing address is 726 Jackson Place, NW., Washington, DC 20503. The OMB DOE Desk Officer may be telephoned at
(202)395-4650. (A copy of your comments should also be provided to EIA's Statistics and Methods Group at the address below.) FOR FURTHER INFORMATION CONTACT: Requests for additional information should be directed to Kara Norman. To ensure receipt of the comments by the due date, submission by FAX (202-287-1705) or e-mail ( *kara.norman@eia.doe.gov* ) is also recommended. The mailing address is Statistics and Methods Group (EI-70), Forrestal Building, U.S. Department of Energy, Washington, DC 20585-0670. Kara Norman may be contacted by telephone at
(202)287-1902. SUPPLEMENTARY INFORMATION: This section contains the following information about the energy information collection submitted to OMB for review:
(1)The collection numbers and title;
(2)the sponsor ( *i.e.* , the Department of Energy component;
(3)the current OMB docket number (if applicable);
(4)the type of request ( *i.e.* , new, revision, extension, or reinstatement);
(5)response obligation ( *i.e.* , mandatory, voluntary, or required to obtain or retain benefits);
(6)a description of the need for and proposed use of the information;
(7)a categorical description of the likely respondents; and
(8)an estimate of the total annual reporting burden ( *i.e.* , the estimated number of likely respondents times the proposed frequency of response per year times the average hours per response). 1. EIA-902, “Annual Geothermal Heat Pump Manufacturers Survey”. 2. Energy Information Administration. 3. *OMB Number:* 1905-0204. 4. 14-month approval requested. 5. Mandatory. 6. The EIA-902 is used to collect data about the manufacture and distribution of geothermal heat pumps and the status of the industry. The information collected will be used by public and private analysts interested in geothermal heat pumps and related energy issues. 7. Business or other for-profit. 8. 85 hours per year (20 respondents × 1 response per year × 4.25 hours per response). Please refer to the supporting statement as well as the proposed forms and instructions for more information about the purpose, who must report, when to report, where to submit, the elements to be reported, detailed instructions, provisions for confidentiality, and uses (including possible nonstatistical uses) of the information. For instructions on obtaining materials, see the FOR FURTHER INFORMATION CONTACT section. Statutory Authority: Section 3507(h)(1) of the Paperwork Reduction Act of 1995 (Pub. L. No. 104-13) (44 U.S.C. 3501 *et seq.* , at 3507(h)(1)). Issued in Washington, DC, September 8, 2006. Jay H. Casselberry, Agency Clearance Officer, Energy Information Administration. [FR Doc. E6-15341 Filed 9-14-06; 8:45 am] BILLING CODE 6450-01-P ENVIRONMENTAL PROTECTION AGENCY [FRL-8220-1] Notice of Disclosure of Confidential Business Information Obtained Under the Comprehensive Environmental Response, Compensation and Liability Act to EPA Contractor GRB Environmental Services, Inc. AGENCY: Environmental Protection Agency (EPA). ACTION: Notice; request for comment. SUMMARY: EPA has authorized GRB Environmental Services Inc. of New York, New York, for access to Information which has been submitted to EPA under the environmental statues administered by the Agency. Some of this information may be claimed or determined to be confidential business information (CBI). DATES: Comments concerning CBI access will be accepted through September 22, 2006. ADDRESSES: Comments should be sent to Philip Ingram, Contracting Officer, Environmental Protection Agency Mail Code: MTS-4-3, 75 Hawthorne Street, San Francisco, CA 94105. Telephone:
(415)972-3715. Notice of Required Determinations, Contract Provisions and Opportunity To Comment Under EPA contract number: EP-R9-06-03, GRB Environmental Services Inc. provides records management support services to the Environmental Protection Agency Region 9. In performing these tasks, GRB Environmental Services Inc. employees have access to agency documents for purposes of document processing, filing, abstracting, analyzing, inventorying, retrieving, tracking, etc. The documents to which GRB Environmental Services Inc. have access to can potentially include documents submitted under the Resource Conservation and Recovery Act and Comprehensive Environmental Response, Compensation, and Liability Act. Some of these documents may contain information claimed as CBI. GRB Environmental Services Inc. is required by contract to protect confidential information. When GRB's need for the documents is completed, GRB will return them to EPA. Dated: August 23, 2006. Keith Takata, Director, Superfund Division, Region IX. [FR Doc. E6-15336 Filed 9-14-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-6679-3] Environmental Impact Statements and Regulations; Availability of EPA Comments Availability of EPA comments prepared pursuant to the Environmental Review Process (ERP), under section 309 of the Clean Air Act and Section 102(2)(c) of the National Environmental Policy Act as amended. Requests for copies of EPA comments can be directed to the Office of Federal Activities at 202-564-7167. An explanation of the ratings assigned to draft environmental impact statements
(EISs)was published in FR dated April 7, 2006 (71 FR 17845). Draft EISs *EIS No. 20050459, ERP No. D-BLM-A82127-00,* Programmatic—Vegetation Treatments Using Herbicides on Bureau of Land Management Public Lands in 17 Westerns, including Alaska *Summary:* EPA expressed environmental concerns about surface and ground water impacts, protected beneficial uses and non-targeted flora and fauna. Additionally, EPA recommended that the final EIS address how meeting goals and endpoints will be evaluated and how monitoring will be conducted. Rating EC2. *EIS No. 20060164, ERP No. D-AFS-J65462-00,* Dakota Prairie Grasslands Noxious Weed Management Project, Implementation, Billings, Slope, Golden Valley, Sioux, Grant, McHenry, Ransom and Richard Counties, ND and Carson, Perkins, and Zwieback Counties, SD. *Summary:* EPA supports the proposed integrated weed management project. Rating LO. *EIS No. 20060178, ERP No. D-WPA-J08026-00,* Big Stone II Power Plant and Transmission Project, Propose Power Plant, Transmission Alternatives, and Substation Modification, (DOE/EIS-0377), US Army COE Section 10 and 404 Permits, Big Stone City, Grant County, SD and Big Stone County, MN. *Summary:* EPA expressed environmental objections because of the project's anticipated wetland impacts, and asked for additional information to determine the least environmentally damaging practicable alternative. Rating EO2. *EIS No. 20060184, ERP No. D-COE-D35062-MD,* Masonville Dredge Material Containment Facility (DMCF), Construction from Baltimore Harbor Channel north of Point-Rock Point Line, U.S. Army COE Section 10 and 404 Permits, Baltimore, MD. *Summary:* EPA expressed environmental concerns about potential impacts associated with the placement of fill into a large area of Patapsco River, and requested that a mitigation plan be developed and be approved by the resource agencies prior to the Final EIS and before the issuance of the Section 404 permit for the project. Rating EC2. *EIS No. 20060220, ERP No. D-BLM-L65513-ID,* Snake River Birds of Prey National Conservation Area, Resource Management Plan, Implementation, Ada, Canyon, Elmore, Owyhee Counties, ID. *Summary:* EPA supports proposed conservation efforts to protect and enhance raptor and raptor prey habitats, but suggests incorporating elements from Alternative C which reduce land disturbances and mitigate for impacts such as erosion, sedimentation, reduced streambank stability, reduce opportunities for spreading noxious plants. Rating EC1. *EIS No. 20060242, ERP No. D-FHW-F40436-WI,* TIER 1-DEIS—US 8 Project, Construction from Wisconsin 35
(N)to U.S. 53, Funding and Right-of-Way Permit, Polk and Barron Counties, WI. *Summary:* EPA expressed environmental concerns about impacts to wetlands, sensitive watersheds and streams, impaired waters and upland forest. Rating EC2. *EIS No. 20060268, ERP No. D-FHW-C40337-DC,* 11th Street Bridges Project, Anacostia Freeway I-295/DC 295, to the Southeast/Southwest Freeway (I-695) Improvements, Funding, NPDES Permit , U.S. Army COE Section 10 and 404 Permits, Washington, DC. *Summary:* EPA expressed environmental concerns about wetland, water quality, aquatic habitat and noise impacts. EPA requested additional information and mitigation. Rating EC2. *EIS No. 20060271, ERP No. D-CGD-A11078-00,* Programmatic—Implementation of the U.S. Coast Guard Nationwide Automatic Identification System Project, Providing Vessel Identification, Tracking and Information Exchange Capabilities to Support National Maritime Interests. *Summary:* EPA does not object to the proposed action. Rating LO. *EIS No. 20060280, ERP No. D-AFS-J65466-00* , North Zone Range 05 Project, Reauthorizing Livestock Grazing on Eight Existing Allotments, Black Hill National Forest, Bearlodge and Northern Hills Ranger Districts, Crook County, WY and Lawrence County, SD. *Summary:* EPA expressed environmental concerns because range condition assessments appear to be used as a replacement for inventory and monitoring protocols providing biological information on riparian areas. The Final EIS should address inconsistencies between the information presented and stated conclusions regarding current conditions of allotments, and impacts of grazing on soil and water quality. In addition, the Final EIS should include water quality data, site-specific monitoring and/or mitigation plan with identified trigger points, and any other supplemental information used to support range management decisions. Rating EC2. *EIS No. 20060299, ERP No. D-FRC-C05149-NY* , Niagara Project, Hydroelectric Relicensing Application FERC No. 2216, Niagara River, Niagara County, NY. *Summary:* EPA expressed environmental concerns about potential cumulative impacts to water levels, and requested that this issue be fully discussed in the final IS. Rating EC2. *EIS No. 20060269, ERP No. DS-COE-D35062-MD* , Masonville Dredged Material Containment Facility, New Information, New Source of Dike Building Material from the Seagirt Dredging Project within the Patapsco River, Funding, Baltimore, MD. *Summary:* EPA expressed environmental concerns about potential impacts associated with the placement of fill into a large area of Patapsco River, and requested that a mitigation plan be developed and be approved by the resource agencies prior to the Final EIS and before the issuance of the Section 404 permit for the project. Rating EC2. Final EISs *EIS No. 20060197, ERP No. F-FHW-J40171-CO* , US Highway 160, Transportation Improvements from Junction U.S. 160/550 Durango—East to Bayfield, US Army COE Section 404 Permit, La Plata County, CO. *Summary:* EPA continues to express environmental concerns about wetland impacts and the mitigation of those impacts. EPA is also concerned about construction-related air quality impacts, and requested mitigation be developed to reduce those impacts. *EIS No. 20060293, ERP No. F-SFW-F64005-00* , Upper Mississippi River National Wildlife and Fish Refuge, Comprehensive Conservation Plan, A New Alternative E: Modified Wildlife and Integrated Public Use, Implementation, MN, WI, Il and IA. *Summary:* EPA does not object to the selection of the preferred alternative. *EIS No. 20060304, ERP No. F-AFS-L65505-ID* , Clear Prong Project, Timber Harvest, Temporary Road Construction, Road Maintenance, Road Decommissioning, Thinning of Sub-Merchantable Tree, and Prescribed Fire, Boise National Forest, Cascade Ranger District, Valley County, ID. *Summary:* EPA's previous concerns have been resolved; therefore, EPA does not object to the proposed action. *EIS No. 20060319, ERP No. F-NPS-G61043-AR* , Pea Ridge National Military Park General Management Plan, Implementation, AR. *Summary:* No formal comment letter was sent to the preparing agency. *EIS No. 20060174, ERP No. FS-AFS-J65438-WY* , Dean Project Area, Proposes to Implement Multiple Resource Management Actions, New Information to Disclose Direct, Indirect, and Cumulative Environmental Impacts, Black Hills National Forest, Bearlodge Ranger District, Sundance, Crook County, WY. *Summary:* EPA continues to express environmental concerns about cumulative impacts to water quality, aquatic life, and terrestrial wildlife. Dated: September 12, 2006. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. E6-15343 Filed 9-14-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [ER-FRL-6679-2] Environmental Impact Statements; Notice of Availability *Responsible Agency:* Office of Federal Activities, General Information
(202)564-7167 or *http://www.epa.gov/compliance/nepa/.* Weekly receipt of Environmental Impact Statements Filed 9/5/2006 through 9/8/2006 Pursuant to 40 CFR 1506.9. *EIS No. 20060367, Final EIS, FHW, UT* , Syracuse Road 1000 West to 2000 West, Transportation Improvements, Funding and U.S. Army COE Section 404 Permit, Syracuse City, Davis County, UT, *Wait Period Ends:* 10/16/2006, *Contact:* Gregory Punske 801-963-0182. *EIS No. 20060368, Draft EIS, NSF, HI* , Advanced Technology Solar Telescope Project, Construction of Site at the University of Hawai'i Institute for Astronomy, Haleakala High Altitude Observatory
(HO)Site, Island of Maui, HI, *Comment Period Ends:* 10/30/2006, *Contact:* Dr. Craig Foltz 703-292-4909. *EIS No. 20060369, Third Final Supplement, COE, CA* , American River Watershed Project, Post Authorization Decision Document, Folsom Dam Raise, Folsom Bridge Project, Proposal to Construct a Permanent Bridge and Roadway across the American River, City of Folsom, Sacramento County, CA, *Wait Period Ends:* 10/16/2006, *Contact:* Jane Rinck, 916-557-6715. *EIS No. 20060370, Final Supplement, AFS, WI* , McCaslin Project, Vegetation Management Activities that are Consistent with Direction in the Nicolet Forest Plan, New Information to Address Inadequate Disclosure of the Cumulative Effect Analysis for Six Animal and Eight Plant Species, Lakewood/Lasna District, Chequamegaon-Nicolet National Forest, Oconto and Forest Counties, WI, *Wait Period Ends:* 10/16/2006, *Contact:* Brian Quinn, 715-762-5176. *EIS No. 20060371, Final EIS, BLM, CO* , Roan Plateau Resource Management Plan Amendment, Including Former Naval Oil Shale Reserves 1 and 3, Garfield and Rio Blanco Counties, CO, *Wait Period Ends:* 10/16/2006, *Contact:* Brenda Williams, 970-947-2800. *EIS No. 20060372, Draft EIS, COE, MN* , East Reserve Project, Construct and Operate an Open Pit Taconite Mine between the Towns of Biwabik and McKinley, St. Louis County, MN, *Comment Period Ends:* 10/30/2006, *Contact:* Jon K. Ahlness, 651-290-5381. *EIS No. 20060373, Draft EIS, BLM, CA* , Sierra Resource Management Plan, Provide Direction for Managing Public Lands, Several Counties, CA, *Comment Period Ends:* 12/13/2006, *Contact:* Sandra McGinnis, 916-985-4474. *EIS No. 20060374, Draft EIS, AFS, CO* , Bull Mountain Natural Gas Pipeline, Construct, Operate and Maintain Natural Gas Pipeline, Issuance of Right-of-Way Grant and Temporary Use Area Permits, Gunnison, Delta, Mesa, Garfield Counties, CO, *Comment Period Ends:* 11/13/2006, *Contact:* Bill Jackson, 970-963-2266. *EIS No. 20060375, Draft EIS, FHW, MT* , Miller Creek Road Project, To Provide Safe and Improved Access between U.S. 93 and the Miller Creek Area, Missoula County, MT, *Comment Period Ends:* 11/06/2006, *Contact:* Theodore Burch, 406-449-5302 Ext 240. *EIS No. 20060376, Draft EIS, FHW, AK* , Knik Arm Crossing Project, To Provide Improved Access between the Municipality of Anchorage and Mantanuska-Susitna Borough, AK, *Comment Period Ends:* 10/30/2006, *Contact:* Ms. Edrie Vinson, 907-586-7464. *EIS No. 20060377, Final EIS, FRC, WA,* Baker River Hydroelectric Project, Application to Relicense the Upper Baker and Lower Baker Developments, Mt. Baker-Snoqualmie National Forest, Baker River, Whatcom and Skagit Counties, WA, *Wait Period Ends:* 10/16/2006, *Contact:* Steve Hocking, 202-502-8753. Amended Notices *EIS No. 20060218, Draft EIS, FHW, NY,* Williamsville Toll Barrier Improvement Project, Improvements from New York Thruway, Interstate 90 between Interchange 48A and 50, Funding, Erie and Genesee Counties, NY, *Comment Period Ends:* 10/06/2006, *Contact:* Amy Jackson-Grove, 518-431-4125. Revision to FR Notice Published 6/2/2006: Extending Comment Period from 8/21/2006 to 10/6/2006. *EIS No. 20060284, Draft EIS, FHW, KY,* I-66 Somerset to London Project, Construction from the Vicinity of the Northern Bypass (I-66) in Somerset, KY to I-75 between London and Corbin Cities, Pulaski, U.S. Army COE Section 404 Permit, Rockcastle and Laurel Counties, KY, *Comment Period Ends:* 10/9/2006, *Contact:* Jose Sepulveda 502-223-6740 Revision of FR Notice Published 07/14/2006: Extended Comment from 8/28/2006 to 10/9/2006 Dated: September 12, 2006. Robert W. Hargrove, Director, NEPA Compliance Division, Office of Federal Activities. [FR Doc. E6-15344 Filed 9-14-06; 8:45 am] BILLING CODE 6560-50-P ENVIRONMENTAL PROTECTION AGENCY [OPP EPA-HQ-OPPT-2002-0001; FRL-8093-2] National Pollution Prevention and Toxics Advisory Committee; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: Under the Federal Advisory Committee Act (FACA), 5 U.S. App.2 (Public Law 92-463), EPA gives notice of a 2-day meeting of the National Pollution Prevention and Toxics Advisory Committee (NPPTAC). The purpose of the meeting is to provide advice and recommendations to EPA regarding the overall policy and operations of the programs of the Office of Pollution Prevention and Toxics (OPPT). DATES: The meeting will be held on October 4, 2006 from 8:30 a.m. to 5:30 p.m., and October 5, 2006 from 10:15 a.m. to 1 p.m. Registration to attend the meeting identified by docket identification
(ID)number EPA-HQ-OPPT-2002-0001, must be received on or before September 25, 2006. Registration will also be accepted at the meeting. Request to provide oral and/or written comments at the meeting, identified as (NPPTAC) October 2006 meeting, must be received in writing on or before September 25, 2006. Request to participate in the meeting, identified by docket ID number EPA-HQ-OPPT-2002-0001, must be received on or before September 25, 2006. For information on access or services for individuals with disabilities, please contact John Alter at
(202)564-9891 or *npptac.oppt@epa.gov* . To request accommodation of a disability, please contact John Alter, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request. Meetings of the Committee Work Groups will take place as follows. The Pollution Prevention
(P2)Work Group will meet on October 2, 2006 from 2:30 p.m. to 5:30 p.m. and on October 3, 2006 from 8:30 a.m. to 11:30 a.m., to discuss activities related to EPA's Pollution Prevention Programs. The Information Integration and Data Use Work Group will meet on October 3, 2006 from 8:30 a.m to 11:30 a.m. The Government Accountability Office
(GAO)Reports Interim Work Group will also meet on October 3, 2006 from 12:30 p.m. to 5:30 p.m. ADDRESS: The meeting will be held at the Crowne Plaza National Airport Hotel, located at 1480 Crystal Drive, Arlington, Virginia. Requests to participate in the meeting may be submitted to the technical person listed under FOR FURTHER INFORMATION CONTACT. FOR FURTHER INFORMATION CONTACT: *For general information contact* : Colby Lintner, Regulatory Coordinator, Environmental Assistance Division (7408M), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202)554-1404; e-mail address: *TSCA-Hotline@epa.gov.* *For technical information contact* : John Alter, (7408), Office of Pollution Prevention and Toxics, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number:
(202)564-9891; e-mail address: *npptac.oppt@epa.gov.* SUPPLEMENTARY INFORMATION: I. General Information A. Does this Action Apply to Me? This action is directed to the public in general, and may be of particular interest to those persons who have an interest in or may be required to manage pollution prevention and toxic chemical programs, individual groups concerned with environmental justice, children's health, or animal welfare, as they relate to OPPT's programs under the Toxic Substances Control Act
(TSCA)and the Pollution Prevention Act (PPA). Since other entities may also be interested, the Agency has not attempted to describe all the specific entities that may be interested in the activities of the NPPTAC. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT. B. How Can I Get Copies of this Document and Other Related Information? 1. *Docket:* EPA has established an official public docket for this action under docket ID number EPA-HQ-OPPT-2002ndash;0001. Publicly available docket materials are available electronically at *http://www.regulations.gov* or in hard copy at the OPPT Docket, EPA Docket Center (EPA/DC), EPA West, Room B102,1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is
(202)566-1744, and the telephone number for the OPPT Docket is
(202)566-0280. 2. Electronic access. You may access this **Federal Register** document electronically through the EPA Internet under the **“Federal Register”** listings at *http://www.epa.gov/fedrgstr.* C. How and to Whom Do I Submit Comments? You may submit comments electronically, by mail, or through hand delivery/courier. To ensure proper receipt by EPA, identify the appropriate docket ID number EPA-HQ-OPPT-2002-0001, include NPPTAC October 2006 Meeting in the subject line on the first page of your comment. 1. *By mail* : OPPT Document Control Office, Environmental Protection Agency, (7407M), 1200 Pennsylvania Avenue, NW, Washington, DC 20460--0001. 2. *Electronically* : At *http://www.regulations.gov.* Follow the on-line instructions for submitting comments. 3. *Hand delivery/courier* : OPPT Document Control Office in EPA East Bldg., Rm. M64 28, 1201 Constitution Ave., NW., Washington DC. II. Background The proposed agenda for the NPPTAC meeting includes: Pollution Prevention, Risk Assessment; Risk Management; Risk Communication; Information Integration and Data Use; The Government Accountability Office
(GAO)Reports; Tribal Lifeways; and NPPTAC Future Planning. The meeting is open to the public. III. How Can I Request to Participate in this Meeting? You may submit a request to participate in this meeting to the technical person listed under FOR FURTHER INFORMATION CONTACT . Do not submit any information in your request that is considered CBI. Requests to participate in the meeting, identified by docket ID number EPA-HQ-OPPT-2002-0001, must be received on or before September 25, 2006. For information on access, or services for individuals with disabilities, please contact John Alter at
(202)564-9891 or e-mail *npptac.oppt@epa.gov* . To request accommodation of a disability, please contact John Alter, preferably at least 10 days prior to the meeting, to give EPA as much time as possible to process your request. List of Subjects Environmental protection, NPPTAC, Pollution prevention, toxics, Toxic chemicals, and Chemical health and safety. Dated: September 8, 2006. Ann E. Goode, Acting Director, Office of Pollution Prevention and Toxics [FR Doc. E6-15339 Filed 9-14-06; 8:45 am] BILLING CODE 6560-50-S ENVIRONMENTAL PROTECTION AGENCY [FRL-8220-2; EPA-HQ-Docket ID No. EPA-ORD-2006-0666] Approaches To Estimating the Waterborne Disease Outbreak Burden in the United States: Uses and Limitations of the Waterborne Disease Outbreak Surveillance System; External Review Draft AGENCY: Environmental Protection Agency (EPA). ACTION: Notice of public comment period. SUMMARY: EPA is announcing a 30-day public comment period for the draft document titled, *Approaches To Estimating the Waterborne Disease Outbreak Burden in the United States: Uses and Limitations of the Waterborne Disease Outbreak Surveillance System* (EPA/600/R-06/069). The document was prepared by the National Center for Environmental Assessment
(NCEA)within EPA's Office of Research and Development. EPA is releasing this draft document solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This document has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination. EPA will consider any public comments submitted in accordance with this notice when revising the document. DATES: The 30-day public comment period begins September 15, 2006, and ends October 16, 2006. Technical comments should be in writing and must be received by EPA by October 16, 2006. ADDRESSES: The draft *Approaches To Estimating the Waterborne Disease Outbreak Burden in the United States: Uses and Limitations of the Waterborne Disease Outbreak Surveillance System* (EPA/600/R-06/069) is available primarily via the Internet on the National Center for Environmental Assessment's home page under the Recent Additions and Publications menus at *http://www.epa.gov/ncea.* A limited number of paper copies are available from Ms. Donna Tucker, Technical Information Manager, NCEA-Cincinnati; telephone: 513-569-7257; facsimile: 513-569-7916; e-mail: *tucker.donna@epa.gov.* If you are requesting a paper copy, please provide your name, your mailing address, and the document title, *Approaches To Estimating the Waterborne Disease Outbreak Burden in the United States: Uses and Limitations of the Waterborne Disease Outbreak Surveillance System* (EPA/600/R-06/069). Comments may be submitted electronically via EPA's E-Docket, by mail, by facsimile, or by hand delivery/courier. Please follow the detailed instructions provided in the Supplementary Information section of this notice. FOR FURTHER INFORMATION CONTACT: For information on the public comment period, contact the Office of Environmental Information Docket; telephone: 202-566-1752; facsimile: 202-566-1753; or e-mail: *ORD.Docket@epa.gov.* For technical information, contact Glenn Rice, NCEA; telephone: 513-569-7813; facsimile: 513-487-2539; or e-mail: *rice.glenn@epa.gov.* SUPPLEMENTARY INFORMATION: I. Information About the Project/Document Information about waterborne disease outbreaks (WBDOs) in the United States is voluntarily reported by State, territorial and local public health agencies to the Centers for Disease Control and Prevention (CDC). CDC and EPA jointly maintain a WBDO database. The database describes outbreak attributes including, among other things, the drinking water system deficiency, the etiologic agent, and the number of individuals who became ill. Underreporting of such events is assumed but the magnitude of underreporting is unknown. This draft document presents an approach for estimating the epidemiologic and economic burden of disease associated with 665 WBDOs reported in the U.S. between 1971 and 2000. The term *disease burden* broadly refers to the magnitude of the impact incurred by society as a consequence of disease in the community (e.g., decrements in a population's health or the associated economic effects) and there are various metrics that can be employed by analysts to quantify burden. In order to capture some of the benefits of drinking water regulations, EPA has typically expressed waterborne disease impacts in terms of epidemiologic and monetary measures; this WBDO burden analysis employs those same measures. Because not all WBDOs in the United States and associated cases of illness are reported, the WBDO database on which this draft document is based is not comprehensive. The extent to which WBDOs are not recognized is unknown and is not examined in this analysis. This draft report develops several quantitative sensitivity analyses to characterize some of the uncertainty in the burden estimates but does not provide an evaluation of the potential impact of under- or overreporting of WBDOs or their associated severity characteristics. The draft report includes recommendations for the collection and reporting of additional outbreak information that would improve the usefulness of the WBDO database for future disease burden estimates. II. How To Submit Technical Comments to EPA's E-Docket Submit your comments, identified by Docket ID No. EPA-ORD-2006-0666 by one of the following methods: • *www.regulations.gov:* Follow the on-line instructions for submitting comments. • *E-mail:* *ORD Docket@epa.gov.* • *Fax:* 202-566-1753. • *Mail:* Office of Environmental Information
(OEI)Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-566-1752. If you provide comments by mail, please submit one unbound original with pages numbered consecutively, and three copies. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies. • *Hand Delivery:* The OEI Docket is located in the Headquarters EPA Docket Center, EPA/DC; EPA West Building, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is 202-566-1744. Such deliveries are only accepted during the Docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information. *Instructions:* Direct your comments to Docket ID No. EPA-ORD-2006-0666. EPA's policy is that all comments received will be included in the public docket without change and may be made available online at *www.regulations.gov* , including any personal information provided, unless the comment includes information claimed to be Confidential Business Information
(CBI)or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through *www.regulations.gov* or e-mail. The *www.regulations.gov* Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through *www.regulations.gov* , your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at *http://www.epa.gov/epahome/dockets.htm.* *Docket:* All documents in the docket are listed in the *www.regulations.gov* index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in *www.regulations.gov* or in hard copy at the OEI Docket in the EPA Headquarters Docket Center. Note: The EPA Docket Center suffered damage due to flooding during the last week of June 2006. The Docket Center is continuing to operate. However, during the cleanup, there will be temporary changes to Docket Center telephone numbers, addresses, and hours of operation for people who wish to make hand deliveries or visit the Public Reading Room to view documents. Consult EPA's **Federal Register** notice at 71 FR 38147 (July 5, 2006) or the EPA Web site at *www.epa.gov/epahome/dockets.htm* for current information on docket operations, locations and telephone numbers. U.S. mail and the procedures for submitting comments to *www.regulations.gov* are not affected by the flooding and will remain the same. Dated: September 7, 2006. Peter W. Preuss, Director, National Center for Environmental Assessment. [FR Doc. E6-15335 Filed 9-14-06; 8:45 am] BILLING CODE 6560-50-P DEPARTMENT OF HEALTH AND HUMAN SERVICES International Development of H5N1 Influenza Vaccines; Funding Opportunity AGENCY: Office of the Secretary, Office of Public Health Emergency Preparedness. ACTION: Notice. *Funding Opportunity Title:* International Development of H5N1 Influenza Vaccines. *Announcement Type:* Single-Source Cooperative Agreement. *Catalog of Federal Domestic Assistance Number:* The Office of Management and Budget
(OMB)Catalog of Federal Domestic Assistance number is 93.019. SUMMARY: The objective of this project is to mitigate any potential global shortage of influenza vaccines and the manufacturing of this vaccine in the event of an influenza pandemic. The Office of Public Health Emergency Preparedness (OPHEP) requires the World Health Organization
(WHO)to perform activities related to pandemic influenza preparedness and planning, particularly in the international development of H5N1 human vaccines (and other pandemic influenza vaccine candidates) and influenza vaccine manufacturing infrastructure building in countries where resources for vaccine acquisition and manufacturing may be limited. The specific countries in which the WHO Secretariat will carry out these activities are Argentina, Brazil, India, Indonesia, Mexico, Romania, Russia, South Africa, and Tunisia. Activities include pre-clinical safety and immunogenicity testing, toxicology testing, clinical vaccine lot manufacturing, scale-up and process development, analytical lot release assay development and validation, and clinical immunogencity assay development and validation. DATES: To receive consideration, applications must be received no later than 5 p.m., Eastern Time, on September 29, 2006. ADDRESSES: The Office of Grants Management within the Office of Public Health and Science of the U.S. Department of Health and Human Services, located at 1101 Wootten Parkway, Rockville, MD 20857, must receive all applications. SUPPLEMENTARY INFORMATION: In the last century, three influenza pandemics have struck the United States and the world, and viruses from birds contributed to all of them. In 1918, the first pandemic infected one-third of the U.S. population, killed over half a million Americans, reduced American life expectancy by 13 years, and killed more than 20 million people worldwide. Following the 1918 outbreak, influenza pandemics in 1957 and 1968 also killed tens of thousands of Americans and millions across the world. The recent limited outbreak of Severe Acute Respiratory Syndrome
(SARS)in 2003 suggests the danger that a modern pandemic would present. The H5N1 strain of avian influenza has become the most threatening influenza virus in the world, and any large scale outbreak of this disease among humans would have grave consequences for global public health. Influenza experts have warned that the reassortment of different H5N1 viruses over the past seven years greatly increases the potential for the viruses to be transmitted more easily from person to person. Medical practitioners have also discovered several other, new avian viruses that can be transmitted to humans. The U.S. Government is concerned that a new influenza virus could become efficiently transmissible among humans. Now spreading through bird populations across Asia, reaching into Europe, the Middle East and, most recently, Africa, the H5N1 strain has infected domesticated birds, such as ducks and chickens, and long range migratory birds. In 1997, the first recorded H5N1 outbreak in humans took place in Hong Kong. H5N1 struck again in late 2003, and has, as of August 17, 2006, resulted in 239 confirmed cases and 140 deaths world-wide, a 59 percent mortality rate. As of now, the H5N1 avian influenza is primarily an animal disease; H5N1 infection in humans has been the result of contact with sick poultry. Unless people come into direct, sustained contact with infected birds, it is unlikely they will contract the disease. The concern is that the virus will acquire the ability for sustained transmission among humans. Equally alarming is that the global influenza vaccine manufacturing capacity of 400-500 million doses of vaccine per year is far short of the needed 4-8 billion doses that may be needed to protect the global population. Influenza vaccine manufacturers are located primarily in industrialized countries and provide vaccine to these countries. However, other countries lack the resources to procure influenza vaccine from the commercial providers and/or are devoid of the necessary vaccine manufacturing infrastructure needed to produce pandemic influenza vaccine in-country. In November, 2005, U.S. President George W. Bush directed all relevant Federal Departments and agencies to take steps to address the threat of avian and pandemic influenza. Drawing on the combined efforts of Government officials and the public health, medical, veterinary, and law enforcement communities, as well as the private sector, this strategy is designed to meet three critical goals: detecting human or animal outbreaks that occur anywhere in the world; protecting the American people by stockpiling vaccines and antiviral drugs, while improving the capacity to produce new vaccines; and preparing to respond at the Federal, State, and local levels in the event an avian or pandemic influenza reaches the United States. One of the primary objectives of the U.S. Government's international efforts on avian and pandemic influenza preparations is to pursue and develop global partnerships to increase preparedness and response capabilities around the world with the intent of stopping, slowing or otherwise limiting the spread of a pandemic to the United States. These efforts include goals of ensuring the rapid reporting of outbreaks and containing such outbreaks beyond the borders of the United States, by taking the following actions: • Work through multilateral health organizations such as the World Health Organization (WHO), the United Nation's Food and Agriculture Organization (FAO), the World Organization for Animal Health (OIE), and regional organizations such as the Asia-Pacific Economic Cooperation
(APEC)forum, as well as through bilateral and multilateral contacts, to do the following: • Support the development and exercising of avian-influenza and pandemic-response plans; • Expand in-country medical, veterinary and scientific capacity to respond to an outbreak; • Educate populations at home and abroad about high-risk practices that increase the likelihood of virus transmission between species; • Encourage nations to develop production capacity and stockpiles to support their response needs, to include the pooling of efforts to create regional capacity; • Ensure that there is maximal sharing of scientific information about influenza viruses between Governments, scientific entities and the private sector; • Work with our international partners to ensure we are all leveraging the most advanced technological approaches available for vaccine production; • Work through the International Partnership on Avian and Pandemic Influenza to develop a coalition of strong partners to coordinate actions to limit the spread of a virus with pandemic potential beyond the location where it is first recognized to protect U.S. interests abroad; and • Where appropriate, offer and coordinate assistance from the United States and other members of the International Partnership. Through such partnerships other bilateral and multilateral initiatives, we will promote these principles and support the development of an international capacity to prepare, detect and respond to an influenza pandemic. For example, the WHO global action plan promotes increased capacity for production of human influenza pandemic vaccines to reduce the anticipated gap between the potential vaccine demand and supply during an influenza pandemic. This announcement seeks to support increased access to vaccines by stimulating influenza vaccine development and manufacturing infrastructure building by institutions in foreign countries as they develop sustainable programs for vaccines to prevent avian H5N1 or other influenza viruses in humans. Within the U.S. Department of Health and Human Services (HHS), the Office of Public Health Emergency Preparedness (OPHEP) intends to award to the WHO Secretariat a maximum grant award of $10,000,000. OPHEP may award subsequent grants or cooperative agreements in future fiscal years for international development of H5N1 vaccine (or other pandemic vaccine candidates), in the event OPHEP receives congressional authority and funding. Only the Secretariat of the World Health Organization is eligible to submit an application for this funding opportunity. Other funds the WHO Secretariat chooses to provide for such efforts, within the WHO Pandemic Influenza Framework may support similar program efforts in other, additional countries or complementary activities in the same countries. I. Funding Opportunity Description Authority: The Department of Defense, Emergency Supplemental Appropriations to Address Hurricanes in the Gulf of Mexico and Pandemic Influenza Act, 2006, Pub. L. 109-148 119 Stat. 2680, 2786 (2005). *Purpose:* The purposes of the award are to do the following: • Support the production of candidate vaccines, in the countries specified, to prevent the H5N1 strain of influenza in humans, under proper biosafety and quality conditions, for clinical trials; • Provide funding for the development and manufacturing of human vaccine candidates against the H5N1 strain of highly pathogenic avian influenza and the establishment of pilot production and commercial-scale vaccine manufacturing processes for non-(pre)clinical safety and immunogenicity testing that could lead to regulatory approval or licensure of a human H5N1 vaccine by national regulatory authorities in the specified countries for the prevention of H5N1 influenza virus infection in humans; and • Develop inactivated H5N1 vaccines by using eggs or qualified cells or cell lines and a virus reassortant qualified by the WHO that contains HA and NA genes derived from a recent human H5N1 influenza strain. Measurable Outcomes Measurable outcomes of the program will be in alignment with the U.S. President's *National Strategy for Pandemic Influenza* and the principles of the International Partnership on Avian and Pandemic Influenza, and one (or more) of the following performance goal(s) for HHS pursuant to the U.S. President's initiative on pandemic-influenza preparedness: • Prevent and contain an incipient epidemic through capacity building and in-country collaboration with international partners; • Work in a manner complementary to and supportive of expanded cooperation with and appropriate support of key multilateral organizations (including the WHO, the FAO and the OIE); • Timely coordination of bilateral and multilateral resource allocations; dedication of domestic resources (human and financial); improvements in public awareness; and development of economic and trade contingency plans; and/or • Increased coordination and harmonization of preparedness, prevention, response and containment activities among nations, complementing domestic and regional preparedness initiatives, and encouraging where appropriate the development of strategic regional initiatives, and actions based on the best available science. Grantee Activities *Grantee activities for this award are as follows:* • Perform activities related to pandemic influenza preparedness and planning, particularly in the international development of H5N1 human vaccines (and other pandemic influenza vaccine candidates) and influenza vaccine manufacturing infrastructure building in countries where resources for vaccine acquisition and manufacturing may be limited. The specific countries in which the WHO Secretariat will carry out these activities are Argentina, Brazil, India, Indonesia, Mexico, Romania, Russia, South Africa, and Tunisia. Activities include pre-clinical safety and immunogenicity testing, toxicology testing, clinical vaccine lot manufacturing, scale-up and process development, analytical lot release assay development and validation, and clinical immunogencity assay development and validation. All procurement transactions or contracts entered into by the WHO shall be conducted in a manner to provide, to the maximum extent practical, open and free competition for public sector and private sector entities in the target countries. The recipient shall be alert to organizational conflicts of interest as well as noncompetitive practices among contractors that may restrict or eliminate competition or otherwise restrain trade. • Undertake relevant activities to develop standard methods and reagents; • Conduct periodic, site visits, with international experts; • Ensure work supported by these grants complies with WHO biosafety guidelines for pandemic-influenza vaccine manufacturing and acceptable to the relevant national regulatory agency; • Provide H5N1 virus reference vaccine strains from WHO influenza virus reference laboratories; and • Provide WHO potency reagent standards, including virus reference antigen and antiserum, for lot-release testing of human vaccines against the H5N1 strain. *Activities not eligible for funding include the following:* • Study design, implementation, and analysis of clinical trials; and • Preparation of vaccine candidates for licensure by a country's national regulatory agency. *HHS Activities for this program are as follows:* 1. Participate in an orientation meeting with the grantee on expectations, regulations and key management requirements, as well as reporting requirements and formats and contents. The orientation could include staff from HHS agencies and the Office of the Special Representative for Avian and Pandemic Influenza at the U.S. Department of State. 2. Provide the WHO Secretariat with the necessary resources and expert assistance in specialized training areas. All influenza virus information obtained or developed as a result of the foregoing activities or other activities funded under this cooperative agreement shall be shared with HHS, the WHO Global Influenza Network, and WHO Collaborating Centers of Influenza, and placed in the public domain, worldwide. If the WHO Secretariat enters into contracts or other agreements to accomplish the requirements of this cooperative agreement, WHO shall include language in such contracts and agreements stating that any information obtained or developed as a result of the foregoing activities or other activities funded under this cooperative agreement shall be shared with HHS, the WHO Global Influenza Network, and WHO Collaborating Centers of Influenza and placed within the public domain, worldwide. The WHO Secretariat shall also include language in said contracts or agreements that makes the United States Federal Government a third-party beneficiary to any information obtained or developed as a result of the foregoing activities or other activities funded under this cooperative agreement. II. Award Information This project will be supported through the cooperative agreement mechanism. HHS anticipates making only one award. The period of performance is September 15, 2006 through September 14, 2007. *Approximate Current Fiscal Year Funding:* $10,000,000. III. Eligibility Information 1. Eligible Applicant The WHO Secretariat is the only worldwide organization with the experience and scientific standing to accomplish the goals set forth in this RFA. It is the recognized world health authority within the United Nations system. It has over 40 years of experience in establishing and monitoring vaccine programs. The WHO has established a pandemic influenza program that includes disease-surveillance, assistance with vaccine production, and through its unique system of WHO Collaborating Laboratories, the technical expertise to recommend and supply unique and relevant reagents necessary for the production and characterization of pandemic influenza vaccines. There is no other organization with this history and capability. Program efforts in other and additional countries may be supported by other funds the WHO Secretariat chooses to provide for such efforts, within the WHO Pandemic Influenza Framework. 2. Cost-sharing or Matching Funds Matching funds are not required for this program. Although matching funds are not required, preference may go to organizations that can leverage additional funds to contribute to program goals. 3. Special Requirements If the application is incomplete or non responsive to the special requirements listed in this section, the application will not enter into the review process. HHS will notify the applicant that the application did not meet submission requirements. • HHS will consider a late application to be nonresponsive. Please see section on Submission Dates and Times. • Section 503, Departments of Labor, Health and Human Services, Education and related agencies, Appropriations Act, 2006, Pub. L. 109-149, 119 Stat. 2833, which states that appropriated funds under the Act shall not be used for lobbying activities, applies. IV. Application and Submission Information 1. Address To Request Application Package Applicants may request application kits by calling 1-(240) 453 8822, or by writing to the Office of Grants Management, Office of Public Health and Science, U.S. Department of Health and Human Services, 1101 Wootten Parkway, Suite 550, Rockville, MD 20852. Applicants may also fax a written request to the HHS/OPHS Office of Grants Management at 1-(240) 453 8823 to obtain a hard copy of the application kit. Applicants must prepare their applications by using Form OPHS 1. 2. Content and Form of Submission *Application:* Applicants must submit a project narrative in English, along with the application forms, in the following format: • *Maximum number of pages:* 50. If your narrative exceeds the page limit, HHS will only review the first 50 pages within the page limit; • *Font size:* 12-point, unreduced; • Single-spaced; • *Paper size:* 8.5 by 11 inches; • *Page margin size:* One inch; • Number all pages of the application sequentially from page one (i.e., the Application Face Page) to the end of the application, including charts, figures, tables, and appendices; • Print only on one side of page; and • Hold application together only by rubber bands or metal clips, and do not bind it in any way. The narrative should address activities over the entire project period, and must include the following items, in the order listed: A. Understanding of the Requirements. The application shall include a discussion of your organization's understanding of the need, purpose and requirements of this cooperative agreement, as well as the U.S. President's National Strategy and the principles of the International Partnership on Avian and Pandemic Influenza. The discussion shall be sufficiently specific, detailed and complete to clearly and fully demonstrate that the applicant has a thorough understanding of all the technical requirements of this announcement. The applicant must describe how it will perform the requirements (meet the goals) in this RFA. The applicant must include a description of what standards will be used to measure the effectiveness and accomplishments of the requirements in the cooperative agreement. Measures must be objective and quantitative, and must measure the intended outcomes. The applicant must submit a section on measures of effectiveness with its application, and they will be an element for evaluation. B. Project Plan *Background and Significance:* • Describe the background and justify the need for the proposed project to enhance or expand the development and manufacturing of human candidate vaccines against the H5N1 strain of influenza in the targeted countries. • Applicants must provide timelines, milestones (as appropriate) and address specific areas of risk, such as scientific, facility, regulatory and mitigation plans to ensure timely completion of the project. C. Staffing and Management Plan The applicant must provide a project staffing and management plan, which must include time lines and sufficient detail to ensure that it can meet the Federal Government's requirements in a timely and efficient manner. The applicant must provide résumés that identify the educational and experience level of any individual(s) who will perform in a key position and other qualifications to show the key individuals' ability to comply with the minimum requirements of this announcement. The applicant must provide a summary of the qualifications of non key personnel. Résumés must be limited to three pages per person. The proposed staffing plan must demonstrate the applicant's ability to recruit, retain, and replace personnel who have the knowledge, experience, local language skills, training and technical expertise commensurate with the requirements of this announcement. The plan must demonstrate the applicant's ability to provide bilingual personnel to train and mentor host country participants. D. Budget Justification The budget justification, limited to 10 pages, will count against the overall 50-page application limit. This justification must comply with the criteria for applications. The applicant must submit, at a minimum, a cost proposal fully supported by information adequate to establish the reasonableness of the proposed amount. The applicant may include additional information in the application appendices, which will not count toward the narrative page limit. This additional information may include Curricula Vitae, Résumés, Organizational Charts, Letters of Support, etc. An agency or organization must have a Dun and Bradstreet Data Universal Numbering System
(DUNS)number to apply for a grant or cooperative agreement from the Federal Government. The DUNS number is a nine digit identification number, which uniquely identifies business entities. Obtaining a DUNS number is easy, and there is no charge. To obtain a DUNS number, access the following Internet address, *http://www.dunandbradstreet.com* , or call 1 866 705 5711. Additional requirements that could require submission of additional documentation with the application appear in Section VI.2, “Administrative and National Policy Requirements.” 3. Submission Dates and Times To be considered for review, applications must be received by the HHS/OPHS Office of Grants Management by 5 p.m., Eastern Time on the date specified in the dates section of the announcement. HHS will consider applications as having met the deadline if we receive them on or before the deadline date. The application due date in this announcement supersedes the instructions in the OPHS 1. Submission Mechanisms HHS/OPHS, which is serving as the awarding agency for HHS/OPHEP, provides multiple mechanisms for the submission of applications, as described in the following sections. Applicants will receive notification via mail from the HHS/OPHS Office of Grants Management to confirm the receipt of applications submitted by using any of these mechanisms. HHS will not accept applications submitted to the HHS/OPHS Office of Grants Management after the deadlines identified below. HHS will not accept for review applications that do not conform to the requirements of the cooperative agreement announcement, and will return such applications to the applicant. Applicants may submit electronically only via the electronic submission mechanisms specified below. HHS will not accept any applications submitted via any other means of electronic communication, including facsimile or electronic mail. While HHS will accept applications in hard copy, we encourage the use of the electronic application submission capabilities provided by the HHS/OPHS eGrants system or the *http://www.Grants.gov* Web site Portal. Applicants must submit electronic grant applications no later than 5 p.m., Eastern Time, on the deadline date specified in the “Submission Dates and Times” section of this announcement, by using one of the electronic submission mechanisms specified below. The HHS/OPHS Office of Grants Management must receive all required hard-copy original signatures and mail in items by no later than 5 p.m., Eastern Time, on the next business day after the deadline date specified in the “Submission Dates and Times” section of this announcement. HHS will not consider applications as valid until the HHS/OPHS Office of Grants Management has received all electronic application components, hard-copy original signatures, and mail in items according to the deadlines specified above. HHS will consider as late application submissions that do not adhere to the due date requirements, and will consider them ineligible. HHS encourages applicants to initiate electronic applications early in the application development process, and to submit prior to or early on the due date. This will allow sufficient time to address any problems with electronic submissions prior to the application deadline. Electronic Submissions via the HHS/OPHS eGrants System The HHS/OPHS electronic grants-management system, eGrants, provides for the electronic submission of applications. Information about this system is available on the OPHS eGrants Web site, at the following Internet address: *https://egrants.osophs.dhhs.gov* ; or interested parties may request it from the HHS/OPHS Office of Grants Management at 1-(240) 453B8822. When submitting applications via the HHS/OPHS eGrants system, applicants must submit a hard copy of the application face page (Standard Form 424) with the original signature of an individual authorized to act for the applicant agency and assume the obligations imposed by the terms and conditions of the grant award. If required, applicants will also need to submit a hard copy of the Standard Form LLL and/or certain Program-related forms (e.g., Program Certifications) with the original signature of an individual authorized to act for the applicant agency. Electronic applications submitted via the HHS/OPHS eGrants system must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. The applicant may identify specific mail in items to send to the HHS/OPHS Office of Grants Management separate from the electronic submission; however, applicants must enter these mail in items on the eGrants Application Checklist at the time of electronic submission, and HHS/OPHS must receive them by the due date requirements specified above. Mail-in items may only include publications, résumés, or organizational documentation. Upon completion of a successful electronic application submission, the HHS/OPHS eGrants system will provide the applicant with a confirmation page to indicate the date and time (Eastern Time) of the electronic application submission. This confirmation page will also provide a listing of all items that constitute the final application submission, including all electronic application components, required hard-copy original signatures, and mail-in items, as well as the mailing address of the HHS/OPHS Office of Grants Management to which applicants must submit all required hard-copy materials. As the HHS/OPHS Office of Grants Management receives items, it will update the electronic application status to reflect the receipt of mail-in items. We recommend applicants monitor the status of their applications in the HHS/OPHS eGrants system to ensure we have received all signatures and mail in items. Electronic Submissions via the *http://www.Grants.gov* Web site Portal The Grants.gov Web site Portal provides organizations with the ability to submit applications for HHS/OPHS grant opportunities. Organizations must successfully complete the necessary registration processes to submit an application. Information about this system is available on the Grants.gov Web site, at the following Internet address: *http://www.grants.gov.* In addition to electronically submitted materials, applicants may be required to submit hard-copy signatures for certain program-related forms, or original materials as required by the announcement. Applicants must review both the cooperative agreement announcement as well as the application guidance provided within the Grants.gov application package to determine such requirements. Applicants must submit separately any required hard-copy materials or documents that require a signature via mail to the HHS/OPHS Office of Grants Management, and which, if required, must contain the original signature of an individual authorized to act for the applicant agency and to assume the obligations imposed by the terms and conditions of the cooperative agreement award. Electronic applications submitted via the Grants.gov Web site Portal must contain all completed online forms required by the application kit, the Program Narrative, Budget Narrative and any appendices or exhibits. HHS must receive all required mail in items by the due date specified above. Mail-in items may only include publications, résumés or organizational documentation. Upon completion of a successful electronic application submission via the Grants.gov Web site Portal, the applicant will receive a confirmation page from Grants.gov to indicate the date and time (Eastern Time) of the electronic application submission, as well as the Grants.gov Receipt Number. It is critical that the applicant print and retain this confirmation, as well as a copy of the entire application package for its records. Grants.gov will validate all applications submitted via the Grants.gov Web site Portal. Any applications deemed invalid by the Grants.gov Web site Portal will not be transferred to the HHS/OPHS eGrants system, and HHS/OPHS has no responsibility for any application not validated and transferred to HHS/OPHS from the Grants.gov Web site Portal. Grants.gov will notify the applicant regarding the application validation status. Once the Grants.gov Web site Portal has successfully validated an application, applicants should immediately mail all required hard-copy materials to the HHS/OPHS Office of Grants Management by the deadlines specified above. It is critical the applicant clearly identify the Organization name and Grants.gov Application Receipt Number on all hard-copy materials. Once Grants.gov has validated an application, it will be proceed electronically to the HHS/OPHS eGrants system for processing. Upon receipt of both the electronic application from the Grants.gov Web site Portal, and the required hard-copy mail in items, applicants will receive notification via mail from the HHS/OPHS Office of Grants Management to confirm the receipt of the application submitted through the Grants.gov Web site Portal. Applicants should contact Grants.gov regarding any questions or concerns about the electronic application process used by the Grants.gov Web site Portal. Mailed or Hand-Delivered Hard-Copy Applications Applicants who submit applications in hard copy (via mail or hand delivered) must submit an original and two copies of the application. An individual authorized to act for the applicant agency or organization and to assume for the organization the obligations imposed by the terms and conditions of the grant award must sign the original application. HHS will consider mailed or hand delivered applications will be considered as having met the deadline if the HHS/OPHS Office of Grant Management receives them on or before 5 p.m., Eastern Time, on the deadline date specified in the “Submission Dates and Times” section of this announcement. The application deadline date requirement specified in this announcement supersedes the instructions in the OPHS 1. HHS will return to the applicant, unread, applications that do not meet the deadline. 4. Intergovernmental Review of Applications Executive Order 12372 does not apply to this program. 5. Funding Restrictions Restrictions, which applicants must take into account while preparing the budget, are as follows: • Alterations and renovations (A&R) are prohibited on grants/cooperative agreements to foreign recipients. “Alterations and renovations” are defined as work that changes the interior arrangements or other physical characteristics of an existing facility or of installed equipment so that it can be used more effectively for its currently designated purpose or adapted to an alternative use to meet a programmatic requirement. Recipients may not use funds for A&R (including modernization, remodeling, or improvement) of an existing building. • Recipients may not use funds for planning, organizing or convening conferences. • Reimbursement of pre-award costs is not allowed. • Recipients may spend funds for reasonable program purposes, including personnel, travel, supplies, and services. Recipients may purchase equipment if deemed necessary to accomplish program objectives; however, they must request prior approval in writing from HHS/OPHEP officials for any equipment with a purchase price in excess of $10,000 USD. • The costs generally allowable in grants/cooperative agreements to domestic organizations are allowable to foreign institutions and international organizations, with the following exception: With the exception of the American University, Beirut and the WHO Secretariat, HHS will not pay indirect costs (either directly or through sub award) to organizations located outside the territorial limits of the United States, or to international organizations, regardless of their location. • Recipients may contract with other organizations under this program; however, the applicant must perform a substantial portion of the project activities (including program management and operations) for which it is requesting funds and the recipient remains responsible for all funds under the award. Contracts will require prior approval in writing from HHS/OPHEP. • Recipients may not use funds awarded under this cooperative agreement to support any activity that duplicates another activity supported by any component of HHS. • Applicants shall state all requests for funds in the budget in U.S. dollars. Once HHS makes an award, HHS will not compensate foreign recipients for currency exchange fluctuations through the issuance of supplemental awards. • The funding recipient must obtain annual audits of these funds (program specific audit) by a U.S. based audit firm with international branches and current licensure/authority in country, and in accordance with International Accounting Standards or equivalent standard(s) approved in writing by HHS. • A fiscal Recipient Capability Assessment may be required, prior to or post award, to review the applicant's business management and fiscal capabilities regarding the handling of U.S. Federal funds. 6. Other Submission Requirements None. V. Application Review Information 1. Criteria *HHS will evaluate applications against the following factors:* *Factor 1:* Does the application reflect a thorough understanding of the RFA and provide an acceptable plan for the accomplishment of these requirements including detailing the process for procurement transactions or contracts to ensure, to the maximum extent practical, open and free competition for public sector and private sector entities in the target countries? (50 points) *Factor 2:* Does the applicant have an established Pandemic Influenza program that includes disease surveillance, and assistance in vaccine production, and does it have the technical expertise to be able to recommend and supply relevant reagents? (25 points) *Factor 3:* Does the applicant have a successful history in working with the United States Government and the U.S. Department of Health and Human Services
(HHS)on pandemic influenza issues? (25 points) 2. Review and Selection Process HHS/OPHEP will review applications for completeness. An incomplete application or an application that is non responsive to the eligibility criteria will not advance through the review process. HHS will notify applicants if their applications did not meet submission requirements. An objective review panel, which could include both Federal employees and non Federal members, will evaluate complete and responsive applications according to the criteria listed in Section V.1, “Criteria,” above. VI. Award Administration Information 1. Award Notices The successful applicant will receive a Notice of Award (NoA). The NoA shall be the only binding, authorizing document between the recipient and HHS. An authorized Grants Management Officer will sign the NoA, and mail it to the recipient fiscal officer identified in the application. Unsuccessful applicants will receive notification of the results of the application review by mail. 2. Administrative and National Policy Requirements A successful applicant must comply with the administrative requirements set forth in 45 CFR part 74 and part 92 as appropriate. The Fiscal Year 2006 Appropriations Act requires that when issuing statements, press releases, requests for proposals, bid solicitations, and other documents describing projects or programs funded in whole or in part with Federal money, the issuance shall clearly state the percentage and dollar amount of the total costs of the program or project financed with Federal money, and the percentage and dollar amount of the total costs of the project or program that will be financed by non governmental sources. 3. Reporting Requirements The applicant must provide The Grants Management Specialist at HHS listed in the “Agency Contacts” section of this announcement with an original, plus two hard copies, as well as an electronic copy of the following reports in English: 1. A quarterly progress report, due no less than 30 days after the end of each quarter of the budget period. The quarterly progress report must contain the following elements: a. Activities and Objectives for the Current Budget Period; b. Financial Progress for the Current Budget Period; c. Proposed Activity Objectives for the New Budget Period; d. Budget; e. Measures of Effectiveness; and f. Additional Requested Information. 2. An annual progress report, due 90 days after the end of the budget period, which must contain a detailed summary of the elements required in the quarterly progress report; 3. Final performance reports, due no more than 90 days after the end of the project period; and 4. A Financial Status Report
(FSR)SF 269 is due 90 days after the close of each 12 month budget period. Recipients must mail the reports to the Grants Management Specialist listed in the “Agency Contacts” section of this announcement. VII. Agency Contacts *For program technical assistance, contact the following:* Robin A. Robinson, Ph.D., Associate Director (Acting) for Medical Counter Measures Programs (Influenza), Office of Public Health Emergency Medical Countermeasures, Office of Public Health Emergency Preparedness, U.S. Department of Health and Human Services, 330 Switzer Bldg., Room 1512, 330 C Street, SW., Washington, DC 20201,
(202)205-3931 office,
(202)205-3915 fax, e-mail: *robin.robinson@ hhs.gov.* Andrew Robertson, Ph.D., Office of Public Health Emergency Preparedness, U.S. Department of Health and Human Services, 200 Independence Avenue, SW., Room 638G, Washington, DC 20201,
(202)401-5839,
(202)690-6512, e-mail: *andrew.robertson@hhs.gov.* *For financial, grants management, or budget assistance, contact:* DeWayne Wynn, Grants Management Specialist, Office of Grants Management, Office of Public Health and Science, Department of Health and Human Services, 1101 Wootten Parkway, Suite 550, Rockville, MD 20857, telephone:
(240)453-8822, e-mail address: *DeWayne.Wynn.os@hhs.gov.* Dated: September 11, 2006. W. Craig Vanderwagen, Assistant Secretary for Public Health Emergency Preparedness, U.S. Department of Health and Human Services. [FR Doc. E6-15325 Filed 9-14-06; 8:45 am] BILLING CODE 4150-37-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-R-38 and CMS-R-96] Agency Information Collection Activities: Submission for OMB Review; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the Agency's function;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Conditions of Certification for Rural Health Clinics and Supporting Regulations in 42 CFR 491.9, 491.10, 491.11; *Use:* The Rural Health Clinic
(RHC)conditions of participation are based on criteria prescribed in law and are designed to ensure that each facility has a properly trained staff to provide appropriate care and to assure a safe physical environment for patients. The Centers for Medicare and Medicaid Services
(CMS)uses these conditions of participation to certify RHCs wishing to participate in the Medicare program. These requirements are similar in intent to standards developed by industry organizations such as the Joint Commission on Accreditation of Hospitals, and the National League of Nursing/American Public Association and merely reflect accepted standards of management and care to which rural health clinics must adhere. *Form Number:* CMS-R-38 (OMB#: 0938-0334); *Frequency:* Recordkeeping and Reporting—Annually and upon initial application for Medicare approval; *Affected Public:* Business or other for-profit and Not-for-profit institutions; *Number of Respondents:* 3,674; *Total Annual Responses:* 3,674; *Total Annual Hours:* 8,816. 2 *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Emergency and Foreign Hospital Services—Beneficiary Statement of Canadian Travel Claims and Supporting Regulations in 42 CFR 424.123; *Use:* The emergency services furnished a beneficiary outside the U.S. are covered under Medicare if the foreign hospital meets the conditions for a domestic nonparticipating hospital in addition to one of the following:
(1)If the emergency is considered to have occurred within the U.S. and the reason for departure for the U.S. was to obtain treatment;
(2)if the emergency occurred in Canada while the beneficiary was traveling between Alaska and another State;
(3)if the Canadian or Mexican hospital is closer, more accessible or adequately equipped to handle the illness or injury; or
(4)services were rendered aboard a ship in an American port or on the same day the ship arrived or departed from that port. *Form Number:* CMS-R-96 (OMB#: 0938-0484); *Frequency:* Reporting—On occasion; *Affected Public:* Individuals or Households, Business or other for-profit, Not-for-profit institutions; *Number of Respondents:* 1,100; *Total Annual Responses:* 1,100; *Total Annual Hours:* 275. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995,* or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov* , or call the Reports Clearance Office on
(410)786-1326. Written comments and recommendations for the proposed information collections must be mailed or faxed within 30 days of this notice directly to the OMB desk officer: OMB Human Resources and Housing Branch, Attention: Carolyn Lovett, New Executive Office Building, Room 10235, Washington, DC 20503. Fax Number:
(202)395-6974. Dated: September 8, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-15307 Filed 9-14-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services [Document Identifier: CMS-2786] Agency Information Collection Activities: Proposed Collection; Comment Request AGENCY: Centers for Medicare & Medicaid Services, HHS. In compliance with the requirement of section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services
(CMS)is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects:
(1)The necessity and utility of the proposed information collection for the proper performance of the agency's functions;
(2)the accuracy of the estimated burden;
(3)ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. *Type of Information Collection Request:* Extension of a currently approved collection; *Title of Information Collection:* Fire Safety Survey Report Forms and Supporting Regulations in 42 CFR 416.44, 418.100, 482.41, 483.70, and 483.470; *Use:* These forms are used by the State Agencies to record data collected to determine compliance with individual conditions during fire safety surveys and report it to the Federal Government. *Form Number:* CMS-2786 M, R, S, T, U, V, W, X, Y (OMB#: 0938-0242; *Frequency:* Reporting—Annually; *Affected Public:* State, Local or Tribal Government; *Number of Respondents:* 27,900; *Total Annual Responses:* 27,900; Total Annual Hours: 2,325. To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS' Web site address at *http://www.cms.hhs.gov/PaperworkReductionActof1995,* or e-mail your request, including your address, phone number, OMB number, and CMS document identifier, to *Paperwork@cms.hhs.gov,* or call the Reports Clearance Office on
(410)786-1326. To be assured consideration, comments and recommendations for the proposed information collections must be received at the address below, no later than 5 p.m. on November 14, 2006. CMS, Office of Strategic Operations and Regulatory Affairs, Division of Regulations Development—A, Attention: Melissa Musotto, Room C4-26-05, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Dated: September 8, 2006. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E6-15308 Filed 9-14-06; 8:45 am] BILLING CODE 4120-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a Modified or Altered System of Records AGENCY: Department of Health and Human Services (HHS), Centers for Medicare & Medicaid Services (CMS). ACTION: Notice of a Modified or Altered System of Records (SOR). SUMMARY: In accordance with the Privacy Act of 1974, we are proposing to modify or alter an existing SOR, “Medicare Appeals System (MAS),” System No. 09-70-5001, last published at 69 **Federal Register**
(FR)75323 (December 16, 2004). CMS is reorganizing its databases because of the impact of the Medicare Prescription Drug, Improvement, and Modernization Act of 2003
(MMA)(Public Law (Pub.L.) 108-173) provisions and the large volume of information the Agency collects to administer the Medicare program. We propose to assign a new CMS identification number to this system to simplify the obsolete and confusing numbering system originally designed to identify the Bureau, Office, or Center that maintained the system of records. The new assigned identifying number for this system should read: System No. 09-70-0566. We propose to broaden the scope of this system with the inclusion of support for two additional appeals processes: documenting policies and procedures relating to National Coverage Determinations and Prescription Drug Coverage appeals. These new processes are added to the current appeals process that include appeals of Medicare claims decisions, Administrative Law Judge hearings, and Medicare Advantage service decisions. We propose to modify existing routine use number 1 that permits disclosure to agency contractors and consultants to include disclosure to CMS grantees who perform a task for the agency. CMS grantees, charged with completing projects or activities that requires CMS data to carry out that activity, are classified separate from CMS contractors and/or consultants. The modified routine use will remain as routine use number 1. We propose to broaden the scope of routine uses number 5 and 6, authorizing disclosures to combat fraud and abuse in the Medicare and Medicaid programs to include combating “waste” which refers to specific beneficiary/recipient practices that result in unnecessary cost to all federally funded health benefit programs. We will delete routine use number 4, authorizing disclosure to support constituent requests made to a Congressional representative. If an authorization for the disclosure has been obtained from the data subject, then no routine use is needed. The Privacy Act allows for disclosures with the “prior written consent” of the data subject. We are modifying the language in the remaining routine uses to provide a proper explanation as to the need for the routine use and to provide clarity to CMS's intention to disclose individual-specific information contained in this system. We will also take the opportunity to update any sections of the system that were affected by the recent reorganization or MMA provisions and to update language in the administrative sections to correspond with language used in other CMS SORs. The primary purpose of this modified system is to collect and maintain information necessary to:
(1)Process level two and level three appeal requests made by an appellant or appealing party;
(2)track appeal data, including: status, type, history, timeliness, and decisions; and
(3)respond to future correspondence related to the case. The information retrieved from this system of records will also be disclosed to:
(1)Support regulatory and policy functions performed within the agency or by a contractor, consultant, or grantee;
(2)another Federal agency;
(3)assist Quality Improvement Organizations;
(4)support litigation involving the agency; and
(5)combat fraud, waste, and abuse. We have provided background information about the modified system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the modified or altered routine uses, CMS invites comments on all portions of this notice. See “Effective Dates” section for comment period. DATES: *Effective Date:* CMS filed a modified or altered SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget
(OMB)on September 6, 2006. To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comments to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, CMS, Mail Stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location, by appointment, during regular business hours, Monday through Friday from 9 a.m.-3 p.m., eastern daylight time. FOR FURTHER INFORMATION CONTACT: Aaron Pleines, Division of Appeals Operations, Medicare Enrollment and Appeals Group, Center for Beneficiary Choices, CMS, Mail Stop S1-05-06, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. He can also be reached by telephone at 410-786-2137, or via e-mail at *Aaron.Pleines@cms.hhs.gov* . SUPPLEMENTARY INFORMATION: In 1987, CMS established this SOR under the authority of sections 205, 1155, 1156, 1869, and 1872 of the Social Security Act. Notice of this system, “Medicare Hearings and Appeals System
(MHAS)System No. 09-70-5001,” was published at 52 FR 34846 (September 15, 1987), an unnumbered routine use for disclosure to the Social Security Administration
(SSA)was added at 61 FR 6645 (February 21, 1996), an unnumbered routine use for SSA was deleted, a routine use for Quality Improvement Organizations and two routine uses for combating fraud and abuse were added at 69 FR 75323 (December 16, 2004). I. Description of the Modified or Altered System of Records A. Statutory and Regulatory Basis for SOR Authority for maintenance of the system is given under § 205 of Title II, §§ 1155 and 1156 of Title XI, §§ 1812, 1814, 1816, 1842, 1869, and 1872 of Title XVIII of the Social Security Act (the Act), as amended (42 United States Code (U.S.C.) sections 405, 1320c-4, 1320c-5, 1395d, 1395f, 1395h, 1395u, 1395ff, and 1395ii). Additional authority for this system is given under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law (Pub. L.) 108-173). B. Collection and Maintenance of Data in the System MAS contains information concerning Medicare beneficiaries, physicians, providers, practitioners, suppliers and other persons involved in furnishing items and services to health insurance beneficiaries. Information on beneficiaries includes, but is not limited to: name, address, social security number, health insurance claim number, medical services, equipment and supplies for which Medicare reimbursement is requested, and materials used to determine the amount of benefits allowable under Medicare. Information on appellants, physicians, and other persons include, but is not limited to: name, work address, work phone number, and assigned provider identification number, specialty, medical services for which Medicare reimbursement is requested, and materials used to determine amounts of benefits allowable under Medicare. II. Agency Policies, Procedures, and Restrictions on the Routine Use A. Agency Policies, Procedures, and Restrictions on the Routine Use The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The government will only release MAS information that can be associated with an individual as provided for under “Section III. Proposed Routine Use Disclosures of Data in the System.” Both identifiable and non-identifiable data may be disclosed under a routine use. We will only collect the minimum personal data necessary to achieve the purpose of MAS. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from this system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected, *e.g.* , to collect and maintain information necessary to:
(1)Process level two and level three appeal requests made by an appellant or appealing party;
(2)track appeal data, including: status, type, history, timeliness, and decisions; and
(3)respond to future correspondence related to the case. 2. Determines that: a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s). 3. Requires the information recipient to: a. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record; b. Remove or destroy at the earliest time all patient-identifiable information; and c. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. 4. Determines that the data are valid and reliable. III. Proposed Routine Use Disclosures of Data in the System A. The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To support agency contractor, consultant, or grantee who have been engaged by the agency to assist in the accomplishment of a CMS function relating to the purposes for this system and who need to have access to the records in order to assist CMS. We contemplate disclosing this information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing a CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor, consultant or grantee to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant or grantee from using or disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant or grantee to return or destroy all information at the completion of the contract. 2. To assist another Federal agency in the accomplishment of a CMS function relating to the purposes for this system and who need to have access to the records in order to support CMS. DOJ may require MAS data to assist them in investigating and prosecuting violations of the Act to which criminal penalties attach, or other criminal statutes as they pertain to certain programs authorized by the Act, and for representing the Secretary of the Department of Health and Human Services. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with another Federal agency to assist in accomplishing CMS functions relating to purposes for this system. 3. To assist Quality Improvement Organizations
(QIO)in connection with the review of claims, or in connection with studies or other review activities, conducted pursuant to Part B of Title XI of the Act and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. QIOs will work to implement quality improvement programs, provide consultation to CMS, its contractors, and to ensure that payment is only made for medically necessary services. QIOs will assist in related monitoring and enforcement efforts, assist CMS and intermediaries in program integrity assessment, investigate beneficiary complaints about quality of care, and prepare summary information for release to CMS. 4. To the Department of Justice (DOJ), court or adjudicatory body 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 DOJ 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, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. Whenever CMS is involved in litigation, and occasionally when another party is involved in litigation and CMS's policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. 5. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste, and abuse. CMS occasionally contracts out certain of its functions or makes grants or cooperative agreements when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, grantee, consultant or other legal agent whatever information is necessary for the agent to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the agent from using or disclosing the information for any purpose other than that described in the contract and requiring the agent to return or destroy all information. 6. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. Other agencies may require MAS information for the purpose of combating fraud, waste, and abuse in such Federally-funded programs. B. Additional Provisions Affecting Routine Use Disclosures To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR parts 160 and 164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that an individual could, because of the small size of the information provided, use this information to deduce the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources, also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of the Modified or Altered System of Records on Individual Rights CMS proposes to modify this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in the system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: September 1, 2006. Charlene Frizzera, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. System No.: 09-70-0566 System Name: “Medicare Appeals System (MAS),” HHS/CMS/CBC. Security Classification: Level Three Privacy Act Sensitive Data. System Location: The Centers for Medicare & Medicaid Services
(CMS)Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850. This system is also located in locations listed in Appendix A. Categories of Individuals Covered by the System: MAS contains information concerning Medicare beneficiaries, physicians, providers, practitioners, suppliers and other persons involved in furnishing items and services to health insurance beneficiaries. Categories of Records in the System: Information on beneficiaries includes, but is not limited to: Name, address, social security number (SSN), health insurance claim number (HICN), medical services, equipment and supplies for which Medicare reimbursement is requested, and materials used to determine the amount of benefits allowable under Medicare. Information on appellants, physicians, and other persons includes, but is not limited to: name, work address, work phone number, and assigned provider identification number, specialty, medical services for which Medicare reimbursement is requested, and materials used to determine amounts of benefits allowable under Medicare. Authority For Maintenance of the System: Authority for maintenance of the system is given under § 205 of Title II, §§ 1155 and 1156 of Title XI, §§ 1812, 1814, 1816, 1842, 1869, and 1872 of Title XVIII of the Social Security Act (the Act), as amended (42 United States Code (U.S.C.) sections 405, 1320c-4, 1320c-5, 1395d, 1395f, 1395h, 1395u, 1395ff, and 1395ii). Additional authority for this system is given under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Public Law (Pub. L.) 108-173). Purpose(s) of the System: The primary purpose of this modified system is to collect and maintain information necessary to:
(1)Process level two and level three appeal requests made by an appellant or appealing party;
(2)track appeal data, including: status, type, history, timeliness, and decisions; and
(3)respond to future correspondence related to the case. The information retrieved from this system of records will also be disclosed to:
(1)Support regulatory and policy functions performed within the agency or by a contractor, consultant, or grantee;
(2)another Federal agency;
(3)assist Quality Improvement Organizations;
(4)support litigation involving the agency; and
(5)combat fraud, waste, and abuse. Routine Uses of Records Maintained in the System, Including Categories of Users and the Purposes of Such Uses: A. The Privacy Act Allows Us To Disclose Information Without an Individual's Consent if the Information Is To Be Used for a Purpose That Is Compatible With the Purpose(s) for Which the Information Was Collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To support agency contractor, consultant, or grantee who have been engaged by the agency to assist in the accomplishment of a CMS function relating to the purposes for this system and who need to have access to the records in order to assist CMS. 2. To assist another Federal agency in the accomplishment of a CMS function relating to the purposes for this system and who need to have access to the records in order to support CMS. 3. To assist Quality Improvement Organizations
(QIO)in connection with the review of claims, or in connection with studies or other review activities, conducted pursuant to Part B of Title XI of the Act and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. 4. To the Department of Justice (DOJ), court or adjudicatory body 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 DOJ 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, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. 5. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such program. 6. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures. To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR parts 160 and 164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that an individual could, because of the small size of the information provided, use this information to deduce the identity of the beneficiary). Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System: Storage: All records are stored on computer diskette and magnetic storage media. Retrievability: Information can be retrieved by the name, SSN, HICN, and assigned provider number. Safeguards: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: The Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. Retention and Disposal: Records are maintained in a secure storage area with identifiers. Disposal occurs ten years after the final determination of the case is completed. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. System Manager(s) and Address: Director, Division of Appeals Operations, Medicare Enrollment and Appeals Group, Center for Beneficiary Choices, CMS, Mail Stop S1-05-06, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Notification Procedure: For purpose of access, the subject individual should write to the system manager who will require the system name, HICN, address, date of birth, and gender, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), and SSN. Furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay. Record Access Procedure: For purpose of access, use the same procedures outlined in Notification Procedures above. Requestors should also specify the record contents being sought. (These procedures are in accordance with department regulation 45 CFR 5b.5(a)(2)). Contesting Records Procedures: The subject individual should contact the system manager named above, and reasonably identify the records and specify the information to be contested. In addition the individual should state the corrective action sought and the reasons for the correction with supporting justification. (These Procedures are in accordance with Department regulation 45 CFR 5b.7). Records Source Categories: Sources on information contained in this records system include data collected from the individual on the completed form requesting a Medicare hearing or appeal. In addition, information contained in this system may be obtained from Medicare carriers or intermediaries and Quality Improvement Organizations' records. Systems Exempted from Certain Provisions of the Act: None. Appendix A. Health Insurance Claims Medicare records are maintained at the CMS Central Office (see section 1 below for the address). Health Insurance Records of the Medicare program can also be accessed through a representative of the CMS Regional Office (see section 2 below for addresses). Medicare claims records are also maintained by private insurance organizations that share in administering provisions of the health insurance programs. These private insurance organizations, referred to as carriers and intermediaries, are under contract to the Centers for Medicare & Medicaid Services to perform specific task in the Medicare program (see section 3 below for addresses for intermediaries, section 4 for addresses for carriers, and section 5 for addresses for the Payment Safeguard Contractors). 1. Central Office Address CMS Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850. 2. CMS Regional Offices • Boston Region—Connecticut, Maine, Massachusetts, New Hampshire, Rhode Island, Vermont. John F. Kennedy Federal Building, Room 1211, Boston, Massachusetts 02203. Office Hours: 8:30 a.m.-5 p.m. • New York Region—New Jersey, New York, Puerto Rico, Virgin Islands. 26 Federal Plaza, Room 715, New York, New York 10007. Office Hours: 8:30 a.m.-5 p.m. • Philadelphia Region—Delaware, District of Columbia, Maryland, Pennsylvania, Virginia, West Virginia. Post Office Box 8460, Philadelphia, Pennsylvania 19101. Office Hours: 8: 30 a.m.-5 p.m. • Atlanta Region—Alabama, North Carolina, South Carolina, Florida, Georgia, Kentucky, Mississippi, Tennessee. 101 Marietta Street, Suite 702, Atlanta, Georgia 30223. Office Hours: 8:30 a.m.-4:30 p.m. • Chicago Region—Illinois, Indiana, Michigan, Minnesota, Ohio, Wisconsin. Suite A—824, Chicago, Illinois 60604. Office Hours: 8 a.m.-4:45 p.m. • Dallas Region—Arkansas, Louisiana, New Mexico, Oklahoma, Texas. 1200 Main Tower Building, Dallas, Texas. Office Hours: 8 a.m.-4:30 p.m. • Kansas Region—Iowa, Kansas, Missouri, Nebraska. New Federal Office Building, 601 East 12th Street—Room 436, Kansas City, Missouri 64106. Office Hours: 8 a.m.-4:45 p.m. • Denver Region—Colorado, Montana, North Dakota, South Dakota, Utah, Wyoming. Federal Office Building, 1961 Stout St—Room 1185, Denver, Colorado 80294. Office Hours: 8 a.m.-4:30 p.m. • San Francisco Region—American Samoa, Arizona, California, Guam, Hawaii, Nevada. Federal Office Building, 10 Van Ness Avenue, 20th Floor, San Francisco, California 94102. Office Hours: 8 a.m.-4:30 p.m. • Seattle Region—Alaska, Idaho, Oregon, Washington. 1321 Second Avenue, Room 615, Mail Stop 211, Seattle, Washington 98101. Office Hours: 8 a.m.-4:30 p.m. 3. Intermediary Addresses (Hospital Insurance) • Medicare Coordinator, Assoc. Hospital Serv. Main (ME BC), 2 Gannett Drive, South Portland, ME 04106-6911. • Medicare Coordinator, Anthem New Hampshire, 300 Goffs Falls Road, Manchester, NH 03111-0001. • Medicare Coordinator, BC/BS Rhode Island (RI BC), 444 Westminster Street, Providence, RI 02903-3279. • Medicare Coordinator, Empire Medicare Services, 400 S. Salina Street, Syracuse, NY 13202. • Medicare Coordinator, Cooperativa, P.O. Box 363428, San Juan, PR 00936-3428. • Medicare Coordinator, Maryland B/C, P.O. Box 4368, 1946 Greenspring Ave., Timonium, MD 21093. • Medicare Coordinator, Highmark, P5103, 120 Fifth Avenue Place, Pittsburgh, PA 15222-3099. • Medicare Coordinator, United Government Services, 1515 N. Rivercenter Dr., Milwaukee, WI 53212. • Medicare Coordinator, Alabama B/C, 450 Riverchase Parkway East, Birmingham, AL 35298. • Medicare Coordinator, Florida B/C, 532 Riverside Ave., Jacksonville, FL 32202-4918. • Medicare Coordinator, Georgia B/C, P.O. Box 9048, 2357 Warm Springs Road, Columbus, GA 31908. • Medicare Coordinator, Mississippi B/C B MS, P.O. Box 23035, 3545 Lakeland Drive, Jackson, MI 9225-3035. • Medicare Coordinator, North Carolina B/C, P.O. Box 2291, Durham, NC 27702-2291. • Medicare Coordinator, Palmetto GBA A/RHHI, 17 Technology Circle, Columbia, SC 29203-0001. • Medicare Coordinator, Tennessee B/C, 801 Pine Street, Chattanooga, TN 37402-2555. • Medicare Coordinator, Anthem Insurance Co. (Anthem IN), P.O. Box 50451, 8115 Knue Road, Indianapolis, IN 46250-1936. • Medicare Coordinator, Arkansas B/C, 601 Gaines Street, Little Rock, AR 72203. • Medicare Coordinator, Group Health of Oklahoma, 1215 South Boulder, Tulsa, OK 74119-2827. • Medicare Coordinator, Trailblazer, P.O. Box 660156, Dallas, TX 75266-0156. • Medicare Coordinator, Cahaba GBA, Station 7, 636 Grand Avenue, Des Moines, IA 50309-2551. • Medicare Coordinator, Kansas B/C, P.O. Box 239, 1133 Topeka Ave., Topeka, KS 66629-0001. • Medicare Coordinator, Nebraska B/C, P.O. Box 3248, Main PO Station, Omaha, NE 68180-0001. • Medicare Coordinator, Mutual of Omaha, P.O. Box 1602, Omaha, NE 68101. • Medicare Coordinator, Montana B/C, P.O. Box 5017, Great Falls Div., Great Falls, MT 59403-5017. • Medicare Coordinator, Noridian, 4510 13th Avenue S.W., Fargo, ND 58121-0001. • Medicare Coordinator, Utah B/C, P.O. Box 30270, 2455 Parleys Way, Salt Lake City, UT 84130-0270. • Medicare Coordinator, Wyoming B/C, 4000 House Avenue, Cheyenne, WY 82003. • Medicare Coordinator, Arizona B/C, P.O. Box 37700, Phoenix, AZ 85069. • Medicare Coordinator, UGS, P.O. Box 70000, Van Nuys, CA 91470-0000. • Medicare Coordinator, Regents BC, P.O. Box 8110 M/S D-4A, Portland, OR 97207-8110. • Medicare Coordinator, Premera BC, P.O. Box 2847, Seattle, WA 98111-2847. 4. Medicare Carriers • Medicare Coordinator, NHIC, 75 Sargent William Terry Drive, Hingham, MA 02044. • Medicare Coordinator, B/S Rhode Island (RI BS), 444 Westminster Street, Providence, RI 02903-2790. • Medicare Coordinator, Trailblazer Health Enterprises, Meriden Park, 538 Preston Ave., Meriden, CT 06450. • Medicare Coordinator, Upstate Medicare Division, 11 Lewis Road, Binghamton, NY 13902. • Medicare Coordinator, Empire Medicare Services, 2651 Strang Blvd., Yorktown Heights, NY 10598. • Medicare Coordinator, Empire Medicare Services, NJ, 300 East Park Drive, Harrisburg, PA 17106. • Medicare Coordinator, Triple S, #1441 F.D., Roosevelt Ave., Guaynabo, PR 00968. • Medicare Coordinator, Group Health Inc., 4th Floor, 88 west End Avenue, New York, NY 10023. • Medicare Coordinator, Highmark, P.O. Box 89065, 1800 Center Street, Camp Hill, PA 17089-9065. • Medicare Coordinator, Trailblazers Part B, 11150 McCormick Drive, Executive Plaza 3 Suite 200, Hunt Valley, MD 21031. • Medicare Coordinator, Trailblazer Health Enterprises, Virginia, P.O. Box 26463, Richmond, VA 23261-6463. United Medicare Coordinator, Tricenturion, 1 Tower Square, Hartford, CT 06183. • Medicare Coordinator, Alabama B/S, 450 Riverchase Parkway East, Birmingham, AL 35298. • Medicare Coordinator, Cahaba GBA, 12052 Middleground Road, Suite A, Savannah, GA 31419. • Medicare Coordinator, Florida B/S, 532 Riverside Ave., Jacksonville, FL 32202-4918. • Medicare Coordinator, Administar Federal, 9901 Linnstation Road, Louisville, KY 40223. • Medicare Coordinator, Palmetto GBA, 17 Technology Circle, Columbia, SC 29203-0001. • Medicare Coordinator, CIGNA, 2 Vantage Way, Nashville, TN 37228. • Medicare Coordinator, Railroad Retirement Board, 2743 Perimeter Parkway, Building 250, Augusta, GA 30999. • Medicare Coordinator, Cahaba GBA, Jackson Miss., P.O. Box 22545, Jackson, MI 39225-2545. • Medicare Coordinator, Administar Federal (IN), 8115 Knue Road, Indianapolis, IN 46250-1936. • Medicare Coordinator, Wisconsin Physicians Service, P.O. Box 8190, Madison, WI 53708-8190. • Medicare Coordinator, Nationwide Mutual Insurance Co., P.O. Box 16788, 1 Nationwise Plaza, Columbus, OH 3216-6788. • Medicare Coordinator, Arkansas B/S, 601 Gaines Street, Little Rock, AR 72203. • Medicare Coordinator, Arkansas-New Mexico, 601 Gaines Street, Little Rock, AR 72203. • Medicare Coordinator, Palmetto GBA—DMERC, 17 Technology Circle, Columbia SC 29203-0001. • Medicare Coordinator, Trailblazer Health Enterprises, 901 South Central Expressway, Richardson, TX 75080. • Medicare Coordinator, Nordian, 636 Grand Avenue, Des Moines, IA 50309-2551. • Medicare Coordinator, Kansas B/S, P.O. Box 239, 1133 Topeka Ave., Topeka, KS 66629. • Medicare Coordinator, Kansas B/S—NE, P.O. Box 239, 1133 Topeka Ave., Topeka, KS 66629. • Medicare Coordinator, Montana B/S, P.O. Box 4309, Helena, MT 59601. • Medicare Coordinator, Nordian, 4305 13th Avenue South, Fargo, ND 58103-3373. • Medicare Coordinator, Noridian BCBSND (CO), 730 N. Simms #100, Golden, CO 80401-4730. • Medicare Coordinator, Noridian BCBSND (WY), 4305 13th Avenue South, Fargo, ND 58103-3373. • Medicare Coordinator, Utah B/S, P.O. Box 30270, 2455 Parleys Way, Salt Lake City, UT 84130-0270. • Medicare Coordinator, Transamerica Occidental, P.O. Box 54905, Los Angeles, CA 90054-4905. • Medicare Coordinator, NHIC—California, 450 W. East Avenue, Chico, CO 95926. • Medicare Coordinator, Cigna, Suite 254, 3150 Lakeharbor, Boise, ID 83703. • Medicare Coordinator, Cigna, Suite 506, 2 Vantage Way, Nashville, TN 37228. 5. Payment Safeguard Contractors • Medicare Coordinator, Aspen Systems Corporation, 2277 Research Blvd., Rockville, MD 20850. • Medicare Coordinator, DynCorp Electronic Data Systems (EDS), 11710 Plaza America Drive 5400 Legacy Drive, Reston, VA 20190-6017. • Medicare Coordinator, Lifecare management Partners Mutual of Omaha Insurance Co., 6601 Little Rive Turnpike, Suite 300 Mutual of Omaha Plaza, Omaha, NE 68175. • Medicare Coordinator, Reliance Safeguard Solutions, Inc., P.O. Box 30207 400 South Salina Street, 2890 East Cottonwood Parkway, Syracuse, NY 13202. • Medicare Coordinator, Science Applications International Inc., 6565 Arlington Blvd. P.O. Box 100282, Falls Church, VA. • Medicare Coordinator, California Medical Review, Inc., Integriguard Division Federal Sector Civil Group One Sansome Street, San Francisco, CA 94104-4448. • Medicare Coordinator, Computer Sciences Corporation Suite 600 3120 Timanus Lane, Baltimore, MD 21244. • Medicare Coordinator, Electronic Data System (EDS), 11710 Plaza American Drive, 5400 Legacy Drive, Plano, TX 75204. • Medicare Coordinator, TriCenturion, L.L.C., P.O. Box 100282, Columbia, SC 29202. 6. Qualified Independent Contractors • Medicare Contractor, Maximus Federal Services, Inc., 1040 First Avenue, Suite 400, King of Prussia, PA 19406. • Medicare Contractor, Maximus Federal Services, Inc., 50 Square Drive, Victor, NY 19406. • Medicare Contractor, Q 2 Administrators, 17 Technology Circle, Columbia, SC 29203. • Medicare Contractor, Q 2 Administrators, 5150 East Dublin-Granville Road, Suite 200, Westerville, OH 43081. • Medicare Contractor, First Coast Service Options, 532 Riverside Avenue, Jacksonville, FL 32202. [FR Doc. E6-15128 Filed 9-14-06; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare & Medicaid Services Privacy Act of 1974; Report of a New System of Records AGENCY: Department of Health and Human Services (HHS), Center for Medicare & Medicaid Services (CMS). ACTION: Notice of a New System of Records (SOR). SUMMARY: In accordance with the requirements of the Privacy Act of 1974, we are proposing to establish a new system titled, “Chronic Condition Data Repository (CCDR), System No. 09-70-0573.” The program is mandated by Section 723 of the Medicare Prescription Drug Improvement and Modernization Act of 2003
(MMA)(Public Law (Pub. L.) 108-173), which was enacted into law on December 8, 2003, and amended Title XVIII of the Social Security Act (the Act). The CCDR program seeks to establish a data repository to study chronically ill Medicare beneficiaries. This data repository will integrate existing data to support studies for improving the quality of care and studies for reducing the cost of care for chronically ill Medicare beneficiaries. The statute is designed to reduce program spending, make current Medicare program data more readily available to researchers to study chronic illness in the Medicare population, improve process time for research data request, focus on analytic prospective verses operational, and utilize data extraction tools to organize the data. The data collected and maintained in this system are retrieved from the following databases: Medicare Drug Data Processing System, System No. 09-70-0553 (70 **Federal Register**
(FR)58436 (October 6, 2005)); Medicare Beneficiary Database, System No. 09-70-0536 (66 FR 63392 (December 6, 2001)); Medicare Advantage Prescription Drug System, System No. 09-70-4001 (70 FR 60530 (October 18, 2005)); Medicaid Statistical Information System, System No. 09-70-6001 (67 FR 48906 (July 26, 2002)); Retiree Drug Subsidy Program, System No. 09-70-0550 (70 FR 41035 (July 15, 2005)); Common Working File, System No. 09-70-0526 (67 FR 3210 (January 23, 2002)); National Claims History, System No. 09-70-0005 (67 FR 57015 (September 6, 2002)); Enrollment Database, System No. 09-70-0502 (67 FR 3203 (January 23, 2002)); Carrier Medicare Claims Record, System No. 09-70-0501 (67 FR 54428 (August 22, 2002)); Intermediary Medicare Claims Record, System No. 09-70-0503 (67 FR 65982 (October 29, 2002)); Unique Physician/Provider Identification Number, System No. 09-70-0525 (69 FR 75316 (December 16, 2004)); Medicare Supplier Identification File, System No. 09-70-0530 (67 FR 48184 (July 23, 2002)), A Current Beneficiary Survey, System No. 09-70-6002 (66 FR 15496 (March 19, 2001)); National Plan & Provider Enumerator System, System No. 09-70-0008, (63 FR 40297 (July 28, 1998)); Long Term Care MDS, System No. 09-70-1517 (67 FR 6714 (February 13, 2002)); HHA Outcome and Assessment Information Set, System No. 09-70-9002 (66 FR 66903 (December 27, 2001)); and Integrated Data Repository, System No. 09-70-0571 (To be published). The purpose of this system is to collect and maintain a person-level view of identifiable data to establish a data repository to study chronically ill Medicare beneficiaries. This system will utilize data extraction tools to support accessing data by chronic conditions and process complex customized research data requests related to chronic illnesses. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent;
(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;
(4)support Quality Improvement Organizations (QIO);
(5)support litigation involving the agency; and
(6)combat fraud, waste, and abuse in certain Federally-funded health benefits programs. We have provided background information about the new system in the SUPPLEMENTARY INFORMATION section below. Although the Privacy Act requires only that CMS provide an opportunity for interested persons to comment on the proposed routine uses, CMS invites comments on all portions of this notice. See “Effective Dates” section for comment period. DATES: *Effective Date:* CMS filed a new SOR report with the Chair of the House Committee on Government Reform and Oversight, the Chair of the Senate Committee on Homeland Security & Governmental Affairs, and the Administrator, Office of Information and Regulatory Affairs, Office of Management and Budget
(OMB)on September 6, 2006. To ensure that all parties have adequate time in which to comment, the new system will become effective 30 days from the publication of the notice, or 40 days from the date it was submitted to OMB and the Congress, whichever is later. We may defer implementation of this system or one or more of the routine use statements listed below if we receive comments that persuade us to defer implementation. ADDRESSES: The public should address comment to the CMS Privacy Officer, Division of Privacy Compliance, Enterprise Architecture and Strategy Group, CMS, Mail-stop N2-04-27, 7500 Security Boulevard, Baltimore, Maryland 21244-1850. Comments received will be available for review at this location by appointment during regular business hours, Monday through Friday from 9 a.m.-3 p.m., eastern time. FOR FURTHER INFORMATION CONTACT: Linh Phuong, Health Insurance Specialist, Information and Methods Group, Office of Research, Development & Information, Mail Stop C3-18-06, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. She can be reached by telephone at 410-786-7055 or e-mail *Linh.Phuong@cms.hhs.gov.* SUPPLEMENTARY INFORMATION: The CCDR will house data that will be easily linked, at the individual patient level, for all Medicare claims, eligibility data, nursing home and home health assessments, and CMS beneficiary survey data. This data repository will transform and summarize this administrative health insurance information into research data. Part of this process involves transforming diagnostic information on a beneficiary's Medicare claims into information about their chronic medical conditions. The data repository will be designed to support research, policy analysis, quality improvement activities, and demonstrations that attempt to foster a better understanding of how to improve the quality of life and contain the health care costs of the chronically ill. I. Description of the Proposed System of Records A. Statutory and Regulatory Basis for SOR The statutory authority for this system is given under the provisions of Section 723 of the Medicare Prescription Drug Improvement, and Modernization Act of 2003. B. Collection and Maintenance of Data in the System This system will collect and maintain individually identifiable and other data collected on Medicare beneficiaries and their providers who provide service to such beneficiaries. Data will be collected from Medicare administrative and claims records. The collected information will include, but is not limited to Medicare claims and eligibility data, name, address, telephone number, health insurance claims number, social security number, race/ethnicity, gender, date of birth, date of death, enrollment in Part A and Part B information, provider name, unique provider identification number, as well as clinical, demographic, health/well-being, and background information relating to Medicare issues. II. Agency Policies, Procedures, and Restrictions on the Routine Use The Privacy Act permits us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such disclosure of data is known as a “routine use.” The Government will only release CCDR information that can be associated with an individual as provided for under “Section III. Proposed Routine Use Disclosures of Data in the System.” Both identifiable and non-identifiable data may be disclosed under a routine use. We will only collect the minimum personal data necessary to achieve the purpose of CCDR. CMS has the following policies and procedures concerning disclosures of information that will be maintained in the system. Disclosure of information from the system will be approved only to the extent necessary to accomplish the purpose of the disclosure and only after CMS: 1. Determines that the use or disclosure is consistent with the reason that the data is being collected; *e.g.* , to collect and maintain a person-level view of identifiable data to establish a data repository to study chronically ill Medicare beneficiaries. 2. Determines that: a. The purpose for which the disclosure is to be made can only be accomplished if the record is provided in individually identifiable form; b. The purpose for which the disclosure is to be made is of sufficient importance to warrant the effect and/or risk on the privacy of the individual that additional exposure of the record might bring; and c. There is a strong probability that the proposed use of the data would in fact accomplish the stated purpose(s). 3. Requires the information recipient to: a. Establish administrative, technical, and physical safeguards to prevent unauthorized use of disclosure of the record; b. Remove or destroy, at the earliest time, all patient-identifiable information; and c. Agree to not use or disclose the information for any purpose other than the stated purpose under which the information was disclosed. 4. Determines that the data are valid and reliable. III. Proposed Routine Use Disclosures of Data in the System The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual or similar agreement with a third party to assist in accomplishing CMS function relating to purposes for this system. CMS occasionally contracts out certain of its functions when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, consultant or grantee whatever information is necessary for the contractor or consultant to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the contractor, consultant or grantee from using or disclosing the information for any purpose other than that described in the contract and requires the contractor, consultant or grantee to return or destroy all information at the completion of the contract. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS's proper payment of Medicare benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the state. Other Federal or state agencies, in their administration of a Federal health program, may require CCDR information in order to support evaluations and monitoring of Medicare claims information of beneficiaries, including proper reimbursement for services provided. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. The CCDR data will provide for research or support of evaluation projects and a broader, longitudinal, national perspective of the status of Medicare beneficiaries. CMS anticipates that many researchers will have legitimate requests to use these data in projects that could ultimately improve the care provided to Medicare beneficiaries and the policies that govern their care. 4. To Quality Improvement Organizations
(QIO)in connection with review of claims, or in connection with studies or other review activities conducted pursuant to Part B of Title XI of the Act, and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. QIOs will work to implement quality improvement programs, provide consultation to CMS, its contractors, and to state agencies. QIOs will assist state agencies in related monitoring and enforcement efforts, assist CMS and intermediaries in program integrity assessment, and prepare summary information for release to CMS. 5. To the Department of Justice (DOJ), court or adjudicatory body 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 DOJ 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, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. Whenever CMS is involved in litigation, and occasionally when another party is involved in litigation and CMS policies or operations could be affected by the outcome of the litigation, CMS would be able to disclose information to the DOJ, court or adjudicatory body involved. 6. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such program. We contemplate disclosing information under this routine use only in situations in which CMS may enter into a contractual, grantee, cooperative agreement or consultant relationship with a third party to assist in accomplishing CMS functions relating to the purpose of combating fraud, waste, and abuse. CMS occasionally contracts out certain of its functions or makes grants or cooperative agreements when doing so would contribute to effective and efficient operations. CMS must be able to give a contractor, grantee, consultant or other legal agent whatever information is necessary for the agent to fulfill its duties. In these situations, safeguards are provided in the contract prohibiting the agent from using or disclosing the information for any purpose other than that described in the contract and requiring the agent to return or destroy all information. 7. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud, waste, or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud, waste, or abuse in such programs. Other agencies may require CCDR information for the purpose of combating fraud, waste, and abuse in such Federally-funded programs. B. Additional Provisions Affecting Routine Use Disclosures To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR parts 160 and 164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that because of the small size, use of this information could allow for the deduction of the identity of the beneficiary). IV. Safeguards CMS has safeguards in place for authorized users and monitors of such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; the Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: all pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. V. Effects of the Proposed System of Records on Individual Rights CMS proposes to establish this system in accordance with the principles and requirements of the Privacy Act and will collect, use, and disseminate information only as prescribed therein. Data in this system will be subject to the authorized releases in accordance with the routine uses identified in this system of records. CMS will take precautionary measures to minimize the risks of unauthorized access to the records and the potential harm to individual privacy or other personal or property rights of patients whose data are maintained in this system. CMS will collect only that information necessary to perform the system's functions. In addition, CMS will make disclosure from the proposed system only with consent of the subject individual, or his/her legal representative, or in accordance with an applicable exception provision of the Privacy Act. CMS, therefore, does not anticipate an unfavorable effect on individual privacy as a result of information relating to individuals. Dated: September 1, 2006. Charlene Frizzera, Acting Chief Operating Officer, Centers for Medicare & Medicaid Services. System No.: 09-70-0573. System Name: “Chronic Condition Data Repository (CCDR),” HHS/CMS/ORDI. Security Classification: Level Three Privacy Act Sensitive Data. System Location: CMS Data Center, 7500 Security Boulevard, North Building, First Floor, Baltimore, Maryland 21244-1850 and at various other contractor locations. Categories of Individuals Covered by the System: This system will collect and maintain individually identifiable and other data collected on Medicare beneficiaries and their providers who provide service to such beneficiaries. Data will be collected from Medicare administrative and claims records. Categories of Records in the System: The collected information will include, but is not limited to Medicare claims and eligibility data, name, address, telephone number, health insurance claims number, social security number, race/ethnicity, gender, date of birth, date of death, enrollment in Part A and Part B information, provider name, unique provider identification number, as well as clinical, demographic, health/well-being, and background information relating to Medicare issues. Authority for Maintenance of the System: The statutory authority for this system is given under the provisions of Section 723 of the Medicare Prescription Drug Improvement, and Modernization Act of 2003. Purpose(s) of the System: The purpose of this system is to collect and maintain a person-level view of identifiable data to establish a data repository to study chronically ill Medicare beneficiaries. This system will utilize data extraction tools to support accessing data by chronic conditions and process complex customized research data requests related to chronic illnesses. Information retrieved from this system may be disclosed to:
(1)Support regulatory, reimbursement, and policy functions performed within the agency or by a contractor, grantee, consultant or other legal agent;
(2)assist another Federal or state agency with information to contribute to the accuracy of CMS's proper payment of Medicare benefits, enable such agency to administer a Federal health benefits program, or to enable such agency to fulfill a requirement of Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds;
(3)support an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects;
(4)support Quality Improvement Organizations (QIO);
(5)support litigation involving the agency; and
(6)combat fraud and abuse in certain Federally-funded health benefits programs. Routine Uses of Records Maintained in The System, Including Categories of Users and The Purposes of Such Uses: The Privacy Act allows us to disclose information without an individual's consent if the information is to be used for a purpose that is compatible with the purpose(s) for which the information was collected. Any such compatible use of data is known as a “routine use.” The proposed routine uses in this system meet the compatibility requirement of the Privacy Act. We are proposing to establish the following routine use disclosures of information maintained in the system: 1. To agency contractors, consultants or grantees, who have been engaged by the agency to assist in the performance of a service related to this collection and who need to have access to the records in order to perform the activity. 2. To another Federal or state agency to: a. Contribute to the accuracy of CMS's proper payment of Medicare benefits; b. Enable such agency to administer a Federal health benefits program, or, as necessary, to enable such agency to fulfill a requirement of a Federal statute or regulation that implements a health benefits program funded in whole or in part with Federal funds; and/or c. Assist Federal/state Medicaid programs within the state. 3. To an individual or organization for a research project or in support of an evaluation project related to the prevention of disease or disability, the restoration or maintenance of health, or payment related projects. 4. To Quality Improvement Organizations
(QIO)in connection with review of claims, or in connection with studies or other review activities conducted pursuant to Part B of Title XI of the Act, and in performing affirmative outreach activities to individuals for the purpose of establishing and maintaining their entitlement to Medicare benefits or health insurance plans. 5. To the Department of Justice (DOJ), court or adjudicatory body 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 DOJ 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, CMS determines that the records are both relevant and necessary to the litigation and that the use of such records by the DOJ, court or adjudicatory body is compatible with the purpose for which the agency collected the records. 6. To a CMS contractor (including, but not necessarily limited to, fiscal intermediaries and carriers) that assists in the administration of a CMS-administered health benefits program, or to a grantee of a CMS-administered grant program, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such program. 7. To another Federal agency or to an instrumentality of any governmental jurisdiction within or under the control of the United States (including any State or local governmental agency), that administers, or that has the authority to investigate potential fraud or abuse in, a health benefits program funded in whole or in part by Federal funds, when disclosure is deemed reasonably necessary by CMS to prevent, deter, discover, detect, investigate, examine, prosecute, sue with respect to, defend against, correct, remedy, or otherwise combat fraud or abuse in such programs. B. Additional Provisions Affecting Routine Use Disclosures. To the extent this system contains Protected Health Information
(PHI)as defined by HHS regulation “Standards for Privacy of Individually Identifiable Health Information” (45 CFR parts 160 and 164, subparts A and E) 65 FR 82462 (12-28-00). Disclosures of such PHI that are otherwise authorized by these routine uses may only be made if, and as, permitted or required by the “Standards for Privacy of Individually Identifiable Health Information.” (See 45 CFR 164.512(a)(1)). In addition, our policy will be to prohibit release even of data not directly identifiable, except pursuant to one of the routine uses or if required by law, if we determine there is a possibility that an individual can be identified through implicit deduction based on small cell sizes (instances where the patient population is so small that because of the small size, use of this information could allow for the deduction of the identity of the beneficiary). Policies and Practices for Storing, Retrieving, Accessing, Retaining, and Disposing of Records in the System: Storage: All records are stored on electronic media. Retrievability: The collected data are retrieved by an individual identifier; *e.g.* , beneficiary name or HICN, and unique provider identification number. Safeguards: CMS has safeguards in place for authorized users and monitors such users to ensure against excessive or unauthorized use. Personnel having access to the system have been trained in the Privacy Act and information security requirements. Employees who maintain records in this system are instructed not to release data until the intended recipient agrees to implement appropriate management, operational and technical safeguards sufficient to protect the confidentiality, integrity and availability of the information and information systems and to prevent unauthorized access. This system will conform to all applicable Federal laws and regulations and Federal, HHS, and CMS policies and standards as they relate to information security and data privacy. These laws and regulations may apply but are not limited to: the Privacy Act of 1974; The Federal Information Security Management Act of 2002; the Computer Fraud and Abuse Act of 1986; the Health Insurance Portability and Accountability Act of 1996; the E-Government Act of 2002, the Clinger-Cohen Act of 1996; the Medicare Modernization Act of 2003, and the corresponding implementing regulations. OMB Circular A-130, Management of Federal Resources, Appendix III, Security of Federal Automated Information Resources also applies. Federal, HHS, and CMS policies and standards include but are not limited to: All pertinent National Institute of Standards and Technology publications; the HHS Information Systems Program Handbook and the CMS Information Security Handbook. Retention And Disposal: CMS will retain information for a total period not to exceed 6 years and 3 months. All claims-related records are encompassed by the document preservation order and will be retained until notification is received from DOJ. System Manager and Address: Director, Division of Survey Management & Data Release, Information and Methods Group, Office of Research, Development & Information, Mail Stop C3-16-07, Centers for Medicare & Medicaid Services, 7500 Security Boulevard, Baltimore, MD 21244-1849. Notification Procedure: For purposes of access, the subject individual should write to the system manager who will require the system name, employee identification number, tax identification number, national provider number, and for verification purposes, the subject individual's name (woman's maiden name, if applicable), HICN, and/or SSN (furnishing the SSN is voluntary, but it may make searching for a record easier and prevent delay). Record Access Procedure: For purposes of access, use the same procedures outlined in Notification Procedures above. Requestors should also reasonably specify the record contents being sought. (These procedures are in accordance with Department regulation 45 CFR 5b.5(a)(2)). Contesting Record Procedures: The subject individual should contact the system manager named above, and reasonably identify the record and specify the information to be contested. State the corrective action sought and the reasons for the correction with supporting justification. (These procedures are in accordance with Department regulation 45 CFR 5b.7). Records Source Categories: The data collected and maintained in this system are retrieved from the following databases: Medicare Drug Data Processing System, Medicare Beneficiary Database, Medicare Advantage Prescription Drug System, Medicaid Statistical Information System, Retiree Drug Subsidy Program, Common Working File, National Claims History, Enrollment Database, Carrier Medicare Claims Record, Intermediary Medicare Claims Record, Unique Physician/Provider Identification Number, Medicare Supplier Identification File, a Current Beneficiary Survey, National Plan & Provider Enumerator System, Long Term Care MDS, HHA Outcome and Assessment Information Set, and Integrated Data Repository. Systems Exempted from Certain Provisions of the Act: None. [FR Doc. E6-15130 Filed 9-14-06; 8:45 am] BILLING CODE 4120-03-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Administration for Children and Families Administration on Children, Youth and Families AGENCY: Administration on Children, Youth and Families, Administration for Children and Families, HHS. ACTION: Noncompetitive Successor Grantee Award. *CFDA#:* 93.616. *Legislative Authority:* Public Law (Pub. L.) 107-133, Promoting Safe and Stable Families Amendments of 2001, Subtitle B. *Amount of Award:* $82,000 for one year. *Project Period:* 7/30/2006-7/29/2007. *Justification for the Exception to Competition:* In a letter dated June 19, 2006, Mr. Neil J. Hufnagel, Board President/Interim Director of Big Brothers Big Sisters of Clinton and Ionia Counties voluntarily relinquished the agency's grant funds to ACF as a result of their merger with Big Brothers Big Sisters of Michigan Capital Region. To ensure that grant monies are obligated and that services provided by the grant funds may continue, Big Brothers of Michigan Capital Region, submitted an application dated July 31, 2006 to become the permanent successor grantee for the final budget and project periods of Grant No. 90CVO172. Big Brothers Big Sisters of Clinton and Ionia Counties was responsible for assisting children in Clinton and Ionia Counties whose parents are incarcerated to alleviate risk factors and to improve their quality of life by providing them with specially-trained adult mentors who can provide supportive relationships, guidance and encouragement. As Big Brothers Big Sisters of Michigan Capital Region is proposing to continue services to the same community with the same staff as previously done by Big Brothers Big Sisters of Clinton and Iona Counties, the Family and Youth Services Bureau
(FYSB)is requesting that Big Brothers Big Sisters of Michigan Capital Region be granted a deviation to be funded as the permanent successor grantee without competition for the remaining twelve months of the project period. FOR FURTHER INFORMATION CONTACT: Curtis Porter, Director, Youth Development Division, Family and Youth Services Bureau, Administration for Children, Youth and Families, Administration for Children and Families, Portals Building, Suite 800, 1250 Maryland Avenue, SW., Washington, DC 20024. Telephone: 202-205-8102 Dated: September 8, 2006. Joan E. Ohl, Commissioner, Administration on Children, Youth and Families. [FR Doc. E6-15324 Filed 9-14-06; 8:45 am] BILLING CODE 4184-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Transmissible Spongiform Encephalopathies Advisory Committee; Amendment of Notice AGENCY: Food and Drug Administration, HHS. ACTION: Notice. The Food and Drug Administration
(FDA)is announcing an amendment to the notice of the meeting of the Transmissible Spongiform Encephalopathies Advisory Committee. This meeting was announced in the **Federal Register** of August 3, 2006 (71 FR 44035). The amendment is being made to reflect a change in the *Date and Time* , *Agenda* , and *Procedure* portions of the document. Specifically, the open public hearing times in the *Procedure* portion of the document were changed. Because of a change in the agenda, the afternoon committee discussion topic will be cancelled. There are no changes other than those stated in this announcement. FOR FURTHER INFORMATION CONTACT: William Freas or Rosanna L. Harvey, Center for Biologics Evaluation and Research (HFM-71), Food and Drug Administration, 1401 Rockville Pike, Rockville, MD 20852-1448, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512392. SUPPLEMENTARY INFORMATION: In the **Federal Register** of August 3, 2006, FDA announced that a meeting of the Transmissible Spongiform Encephalopathies Advisory Committee would be held September 18, 2006 from 8 a.m. to 4:30 p.m. and September 19, 2006 from 8 a.m. to 1 p.m. On page 44035, in the third column, the *Date and Time* portion of the notice is amended to read as follows: *Date and Time* : The meeting will be held on September 18, 2006, from 8:30 a.m. to 4 p.m. and September 19, 2006, from 8 a.m. to 1 p.m. On page 44036, in the first column, the *Agenda* and *Procedure* portions of the notice are amended to read as follows: *Agenda* : On September 18, 2006, the committee will hear updates on the following topics: United States and worldwide bovine spongiform encephalopathies (BSE); variant Creutzfeldt-Jakob disease
(vCJD)epidemiology and transfusion-transmission; blood and plasma donor deferral for transfusion in France since 1980 guidance; and critical factors influencing prion decontamination using sodium hydroxide. The committee will then discuss experimental clearance of transmissible spongiform encephalopathy infectivity in plasma-derived Factor VIII products. In the afternoon, the committee will hear updates on the status of FDA's initiative on communication of the potential exposure to vCJD risk from an investigational product, plasma derived FACTOR XI that was manufactured from UK donor plasma, and a summary of World Heath Organization consultation on distribution of infectivity in tissues of animals and humans with transmissible spongiform encephalopathies. On September 19, 2006, the committee will discuss possible criteria for approval of donor screening tests for vCJD. *Procedure* : Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee. Written submissions may be made to the contact person on or before September 6, 2006. Oral presentations from the public will be scheduled between approximately 11:30 a.m. and 12 noon and 3:30 p.m. and 4 p.m. on September 18, 2006, and between approximately 11:25 a.m. and 11:45 a.m. on September 19, 2006. Time allotted for each presentation may be limited. Those desiring to make formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before September 11, 2006. This notice is issued under the Federal Advisory Committee Act (5 U.S.C. app.2) and 21 CFR part 14, relating to the advisory committees. Dated: September 6, 2006. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E6-15283 Filed 9-14-06; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration Agency Information Collection Activities: Submission for OMB Review; Comment Request Periodically, the Health Resources and Services Administration
(HRSA)publishes abstracts of information collection requests under review by the Office of Management and Budget (OMB), in compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). To request a copy of the clearance requests submitted to OMB for review, call the HRSA Reports Clearance Office on
(301)443-1129. The following request has been submitted to the Office of Management and Budget for review under the Paperwork Reduction Act of 1995: Proposed Project: Faculty Loan Repayment Program
(FLRP)Application (OMB No. 0915-0150)—Extension Under the Health Resources and Services Administration Faculty Loan Repayment Program, health profession graduates from a disadvantaged background may enter into a contract under which HRSA, with the Department of Health and Human Services, will make payments on eligible health professions educational loans in exchange for a minimum of two years of service as a full-time or part-time faculty member of an accredited health professions college or university. Applicants must complete an application and provide all other required documentation including information on all eligible health professions educational loans. The estimated response burden is as follows: Respondent Number of respondents Responses per response Total responses Hours per response Total burden hours Applicants 160 1 160 1 160 Written comments and recommendations concerning the proposed information collection should be sent within 30 days of this notice to: John Kraemer, Human Resources and Housing Branch, Office of Management and Budget, New Executive Office Building, Room 10235, Washington, DC 20503. Dated: September 7, 2006. Cheryl R. Dammons, Director, Division of Policy Review and Coordination. [FR Doc. E6-15286 Filed 9-14-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Health Resources and Services Administration National Vaccine Injury Compensation Program; List of Petitions Received AGENCY: Health Resources and Services Administration, HHS. ACTION: Notice. SUMMARY: The Health Resources and Services Administration
(HRSA)is publishing this notice of petitions received under the National Vaccine Injury Compensation Program (the Program), as required by Section 2112(b)(2) of the Public Health Service
(PHS)Act, as amended. While the Secretary of Health and Human Services is named as the respondent in all proceedings brought by the filing of petitions for compensation under the Program, the United States Court of Federal Claims is charged by statute with responsibility for considering and acting upon the petitions. FOR FURTHER INFORMATION CONTACT: For information about requirements for filing petitions, and the Program in general, contact the Clerk, United States Court of Federal Claims, 717 Madison Place, NW., Washington, DC 20005,
(202)357-6400. For information on HRSA's role in the Program, contact the Director, National Vaccine Injury Compensation Program, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857;
(301)443-6593. SUPPLEMENTARY INFORMATION: The Program provides a system of no-fault compensation for certain individuals who have been injured by specified childhood vaccines. Subtitle 2 of Title XXI of the PHS Act, 42 U.S.C. 300aa-10 *et seq.* , provides that those seeking compensation are to file a petition with the U.S. Court of Federal Claims and to serve a copy of the petition on the Secretary of Health and Human Services, who is named as the respondent in each proceeding. The Secretary has delegated his responsibility under the Program to HRSA. The Court is directed by statute to appoint special masters who take evidence, conduct hearings as appropriate, and make initial decisions as to eligibility for, and amount of, compensation. A petition may be filed with respect to injuries, disabilities, illnesses, conditions, and deaths resulting from vaccines described in the Vaccine Injury Table (the Table) set forth at Section 2114 of the PHS Act or as set forth at 42 CFR 100.3, as applicable. This Table lists for each covered childhood vaccine the conditions which may lead to compensation and, for each condition, the time period for occurrence of the first symptom or manifestation of onset or of significant aggravation after vaccine administration. Compensation may also be awarded for conditions not listed in the Table and for conditions that are manifested outside the time periods specified in the Table, but only if the petitioner shows that the condition was caused by one of the listed vaccines. Section 2112(b)(2) of the PHS Act, 42 U.S.C. 300aa-12(b)(2), requires that the Secretary publish in the **Federal Register** a notice of each petition filed. Set forth below is a list of petitions received by HRSA on April 1, 2006, through June 30, 2006. Section 2112(b)(2) also provides that the special master “shall afford all interested persons an opportunity to submit relevant, written information” relating to the following: 1. The existence of evidence “that there is not a preponderance of the evidence that the illness, disability, injury, condition, or death described in the petition is due to factors unrelated to the administration of the vaccine described in the petition,” and 2. Any allegation in a petition that the petitioner either:
(a)“Sustained, or had significantly aggravated, any illness, disability, injury, or condition not set forth in the Table but which was caused by” one of the vaccines referred to in the Table, or
(b)“Sustained, or had significantly aggravated, any illness, disability, injury, or condition set forth in the Vaccine Injury Table the first symptom or manifestation of the onset or significant aggravation of which did not occur within the time period set forth in the Table but which was caused by a vaccine” referred to in the Table. This notice will also serve as the special master's invitation to all interested persons to submit written information relevant to the issues described above in the case of the petitions listed below. Any person choosing to do so should file an original and three
(3)copies of the information with the Clerk of the U.S. Court of Federal Claims at the address listed above (under the heading “For Further Information Contact”), with a copy to HRSA addressed to Director, Division of Vaccine Injury Compensation Program, Healthcare Systems Bureau, 5600 Fishers Lane, Room 11C-26, Rockville, MD 20857. The Court's caption (Petitioner's Name v. Secretary of Health and Human Services) and the docket number assigned to the petition should be used as the caption for the written submission. Chapter 35 of title 44, United States Code, related to paperwork reduction, does not apply to information required for purposes of carrying out the Program. List of Petitions 1. Bonnie and Paul Narducci on behalf of Jonathan Paul Narducci, Wallingford, Connecticut, Court of Federal Claims Number 06-0266V. 2. Susan Walmsley, Bay Shore, New York, Court of Federal Claims Number 06-0270V. 3. Kimberly and Norman Crawford on behalf of Nicholas Timothy Crawford, Porter, Texas, Court of Federal Claims Number 06-0278V. 4. John Alarcon, Boston, Massachusetts, Court of Federal Claims Number 06-0279V. 5. Catherine and Steven Jameson on behalf of Ronan Jameson, Whispering Pines, North Carolina, Court of Federal Claims Number 06-0281V. 6. Rosenie Clerveaux-Jean on behalf of Samuel Clerveaux-Jean, Coral Springs, Florida, Court of Federal Claims Number 06-0286V. 7. Leanor Sotelo and William Stewart on behalf of William Stewart-Solelo, Austin, Texas, Court of Federal Claims Number 06-0287V. 8. Karen and Paul McCarron on behalf of Katherine McCarron, Boston, Massachusetts, Court of Federal Claims Number 06-0291V. 9. Tanya and Robert Greer on behalf of Robert Greer, Jr., Ruth, Mississippi, Court of Federal Claims Number 06-0297V. 10. Kathleen Magee on behalf of Connor James Magee, Somers Point, New Jersey, Court of Federal Claims Number 06-0298V. 11. David Allen Wiemken on behalf of Sarah So Young Wiemken, APO, AP, XX, Court of Federal Claims Number 06-0301V. 12. Beth Daehler on behalf of Victoria Daehler, Belvidere, Illinois, Court of Federal Claims Number 06-0313V. 13. Janis and Edward Shiflett on behalf of Phillip Shiflett, Melbourne, Florida, Court of Federal Claims Number 06-0318V. 14. Rebecca Duplessis, Norfolk, Virginia, Court of Federal Claims Number 06-0331V. 15. Alicia White on behalf of Alexander Simmons, Atlanta, Georgia, Court of Federal Claims Number 06-0333V. 16. Jennifer Elrod on behalf of Dylan Elrod, Dallas, Texas, Court of Federal Claims Number 06-0349V. 17. Jennifer Elrod on behalf of Jordan Elrod, Dallas, Texas, Court of Federal Claims Number 06-0350V. 18. Angela Ramos and Reginald Fields on behalf of Grant Fields, Columbus, Ohio, Court of Federal Claims Number 06-0353V. 19. Annette and Matt Flynn on behalf of Liam Flynn, Kenosha, Wisconsin, Court of Federal Claims Number 06-0356V. 20. Eduardo Alvarez, Somers Point, New Jersey, Court of Federal Claims Number 06-0370V. 21. Francia and Peter Hirmiz on behalf of Jessica Hirmiz, Chicago, Illinois, Court of Federal Claims Number 06-0371V. 22. Michele Brock on behalf of Ashley Brock, Brunswick, Maine, Court of Federal Claims Number 06-0378V. 23. Jheanelle Walters on behalf of Senon Walters, King George, Virginia, Court of Federal Claims Number 06-0379V. 24. Jheanelle Walters on behalf of Dominic Walters, King George, Virginia, Court of Federal Claims Number 06-0380V. 25. Eileen and Michael Shanks on behalf of Jennifer Lynn Shanks, Baraboo, Wisconsin, Court of Federal Claims Number 06-0385V. 26. Tracey and Ray Baltera on behalf of Annabelle Baltera, Corona Del Mar, California, Court of Federal Claims Number 06-0388V. 27. Tracey and Ray Baltera on behalf of Summer Baltera, Corona Del Mar, California, Court of Federal Claims Number 06-0389V. 28. Tracey and Ray Baltera on behalf of Avalon Baltera, Corona Del Mar, California, Court of Federal Claims Number 06-0390V. 29. Roberta Born, Ashland, Oregon, Court of Federal Claims Number 06-0392V. 30. Ekaterina Katia and Forrest Bowman on behalf of Forrest George Bowman, Corvallis, Oregon, Court of Federal Claims Number 06-0394V. 31. Tim Calhoun on behalf of Nathaniel Powers Calhoun, Somers Point, New Jersey, Court of Federal Claims Number 06-0400V. 32. Tammy and Mark Davis on behalf of Jonathan Davis, Charleston, West Virginia, Court of Federal Claims Number 06-0403V. 33. Jennifer Ross, Pontiac, Michigan, Court of Federal Claims Number 06-0412V. 34. Susan Kang-Smith and Matthew Smith on behalf of Ryan Smith, Boston, Massachusetts, Court of Federal Claims Number 06-0415V. 35. Christina Lorences on behalf of Michael Lorences, Tampa, Florida, Court of Federal Claims Number 06-0419V. 36. Karla and Gregory Allsberry on behalf of Kent Allsberry, Lake Success, New York, Court of Federal Claims Number 06-0426V. 37. Amy Alexander, Cincinnati, Ohio, Court of Federal Claims Number 06-0428V. 38. Lorinda and Billy Roberts on behalf of Kaden Charlton Roberts, Cleveland, Tennessee, Court of Federal Claims Number 06-0429V. 39. Cynthia La Londe on behalf of Matthew La Londe, Boston, Massachusetts, Court of Federal Claims Number 06-0435V. 40. Colleen and James Kearney on behalf of Patrick Kearney, Boston, Massachusetts, Court of Federal Claims Number 06-0438V. 41. Vickie Lindstrom on behalf of Rebecca Skelton, Fayetteville, Arkansas, Court of Federal Claims Number 06-0440V. 42. Camille Dreiling, Salina, Kansas, Court of Federal Claims Number 06-0441V. 43. Sharon and Patric Salvo on behalf of Elizabeth Salvo, Lake Success, New York, Court of Federal Claims Number 06-0445V. 44. Tara Thompson on behalf of Xyra Farrah Rhodes, Petersburg, Virginia, Court of Federal Claims Number 06-0447V. 45. Gwendolyn Laird, Kansas City, Missouri, Court of Federal Claims Number 06-0452V. 46. Melissa and James Troutman on behalf of Brock James Troutman, Minneapolis, Minnesota, Court of Federal Claims Number 06-0455V. 47. Carol Sprague, Newton, New Jersey, Court of Federal Claims Number 06-0458V. 48. Mari and Tsuyoshi Miyake on behalf of Agata Miyake, Charlottesville, Virginia, Court of Federal Claims Number 06-0459V. 49. Robin and Henry Fischer on behalf of Dennis Fischer, Nanuet, New York, Court of Federal Claims Number 06-0460V. 50. Jodi Pinto-Fields and Christopher Fields on behalf of Ella R. Fields, Deceased, Wind Gap, Pennsylvania, Court of Federal Claims Number 06-0461V. 51. Jennifer and Mark Inman on behalf of Mary Elise Inman, Atlanta, Georgia, Court of Federal Claims Number 06-0462V. 52. David Bailey, Dallas, Texas, Court of Federal Claims Number 06-0464V. 53. Phillip Brooks, Bryson City, North Carolina, Court of Federal Claims Number 06-0468V. 54. Teresa and Anthony Fresco on behalf of Daniel Fresco, West Orange, New Jersey, Court of Federal Claims Number 06-0469V. 55. Michelle and Peter Gioe on behalf of Michael Gioe, Lorton, Virginia, Court of Federal Claims Number 06-0470V. 56. Michelle and Peter Gioe on behalf of Cecilia Francis Gioe, Lorton, Virginia, Court of Federal Claims Number 06-0474V. 57. Karen Barnhart on behalf of Jack Barnhart, Dearborn, Michigan, Court of Federal Claims Number 06-0475V. 58. Ashley Whitener, El Paso, Texas, Court of Federal Claims Number 06-0477V. 59. Albina Silveri, Altoona, Pennsylvania, Court of Federal Claims Number 06-0478V. 60. Cindy Marks and David Martin Wittels on behalf of Tyler Luke Wittels, Lake Success, New York, Court of Federal Claims Number 06-0481V. 61. Angelena and Joseph Gonzales on behalf of Tomas Russell Gonzales, Deceased, Shiprock, New Mexico, Court of Federal Claims Number 06-0487V. 62. Jimmie Lee Lazenberry, Jacksonville, Florida, Court of Federal Claims Number 06-0493V. Dated: September 6, 2006. Elizabeth M. Duke, Administrator. [FR Doc. E6-15287 Filed 9-14-06; 8:45 am] BILLING CODE 4165-15-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Proposed Collection; Comment Request; NCI Cancer Information Service Base Demographics/Customer Service Data Collection SUMMARY: 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 National Cancer Institute (NCI), the National Institutes of Health
(NIH)will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget
(OMB)for review and approval. *Proposed Collection:* *Title:* NCI Cancer Information Service Base Demographics/Customer Service Data Collection. *Type of Information Collection Request:* Revision of currently approved collection 0925-0208. *Need and Use of Information Collection:* The National Cancer Institute's Cancer Information Service
(CIS)provides the latest information on cancer, clinical trials, and tobacco cessation. Characterizing clients and how they found out about the CIS is essential to customer service, program planning and promotion. This effort involves a brief survey of clients of the 1-800-4-CANCER and 1-877-44U-QUIT toll-free services and LiveHelp, a web-based chat service. The telephone survey contains eight questions—3 customer service and 5 demographic—asked of a subset of callers (cancer patients, tobacco users, their family or friends, and the general public) at the end of usual service for an annual total of approximately 115,944 callers. All (100%) of these telephone clients will be asked the 3 customer service questions for an annual total of 113,061 callers. Of the 113,061 telephone clients we serve annually, 36% (n=40,702) will be randomly selected and asked five additional demographic questions. The LiveHelp web survey involves 50% of LiveHelp clients the same eight questions (3 customer service questions and 5 demographic questions) for an annual total of approximately 2,883 users. The combined total of clients to be surveyed each year for both telephone and LiveHelp services is 115,944 for a total of annual burden hours of 2,616. *Frequency of Response:* Single time. *Affected Public:* Individuals or households. *Type of Respondents:* Patients, relatives, friends, and general public. The annual reporting burden is as follows: *Estimated Number of Respondents:* 115,944; *Estimated Number of Responses per Respondent:* 1; *Average Burden Hours Per Response:* 0.0167 and *Estimated Total Annual Burden Hours Requested:* 2616. The annualized cost to respondents is estimated at: $47,323. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Type of respondents Estimated number of respondents Estimated number of responses per respondent Average burden hours per response Estimated total annual burden hours requested Telephone Client 1 5 Demographic Questions (average annual sampling rate = 36%) 40,702 1 0.0167 680 3 Customer Service (100% sampling) 113,061 1 0.0167 1888 LiveHelp Clients 2 5 Demographic + 3 Customer Service questions (50% sampling) 2883 1 0.0167 48 Total 115,944 2,616 1 Approximately 36% of telephone and quitline clients will be sampled for the demographic questions. That is, 25% will be routinely sampled and up to 100% will be sampled for short periods of time during special promotions. This will average to be about 36% of all callers annually. The 40,702 clients who are asked the 5 demographic questions are not additional clients as they are included in the 113,061 who answer the 3 customer service questions. However, they do have additional burden as they are asked the 5 the additional demographic questions. Thus, a burden calculation for these additional 5 questions is presented and the total number of respondents is equal to 113,061 for telephone clients plus 2,883 for LiveHelp clients. 2 Approximately 50% of LiveHelp clients will be sampled for demographic and customer service questions. *Request for Comments:* Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points:
(1)Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility;
(2)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)Ways to enhance the quality, utility, and clarity of the information to be collected; and
(4)Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. FOR FURTHER INFORMATION CONTACT: Written comments and/or suggestions regarding the item(s) contained in this notice, especially regarding the estimated public burden and associated response time, should be directed to the: Office of Management and Budget, Office of Regulatory Affairs, New Executive Office Building, Room 10235, Washington, DC 20503, Attention: Desk Officer for NIH. To request more information on the proposed project or to obtain a copy of the data collection plans and instruments, contact Linda Squiers, Ph.D., Project Officer, National Cancer Institute, Cancer Information Service, 6116 Executive Blvd., Suite 3056A, Room 3029, Rockville, MD 20892 or call non-toll-free number 301-594-9075 or E-mail your request, including your address to: *squiersl@mail.nih.gov.* *Comments Due Date:* Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Dated: September 7, 2006. Rachelle Ragland-Greene, NCI Project Clearance Liaison, National Institutes of Health. [FR Doc. E6-15296 Filed 9-14-06; 8:45 am] BILLING CODE 4101-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health Government-Owned Inventions; Availability for Licensing AGENCY: National Institutes of Health, Public Health Service, HHS. ACTION: Notice. SUMMARY: The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing. ADDRESSES: Licensing information and copies of the U.S. patent applications listed below may be obtained by writing to the indicated licensing contact at the Office of Technology Transfer, National Institutes of Health, 6011 Executive Boulevard, Suite 325, Rockville, Maryland 20852-3804; telephone: 301/496-7057; fax: 301/402-0220. A signed Confidential Disclosure Agreement will be required to receive copies of the patent applications. Human Protein Tissue Inhibitor of Metalloproteinases-2 (TIMP-2) Derived Anti-Angiogenic Peptides *Description of Technology:* Cancer is the second leading cause of death in United States and it is estimated that there will be approximately 600,000 deaths caused by cancer in 2006. A major drawback of the existing chemotherapies is the cytotoxic side-effects that are associated with them. Thus, there is a need to develop new therapeutic approaches with reduced side-effects. Anti-angiogenic therapy is a recent approach in cancer therapeutics targeting the formation of blood vessels that are necessary for tumor growth. Recently, the anti-angiogenic molecule bevacizumab (Avastin) has gained approval from the FDA for the first-line treatment of metastatic colon cancer in combination with standard chemotherapy. Human protein tissue inhibitor of metalloproteinases-2 (TIMP-2) has been shown to inhibit angiogenesis in vivo independent of metalloproteinase inhibition. This technology discloses new peptide sequences derived from TIMP-2. They retain their in vivo anti-angiogenic property acting via the same mechanism as TIMP-2 and some of them have significantly higher activity than TIMP-2. Anti-angiogenic peptidomimetics based on this technology can be developed for the treatment of angiogenesis associated diseases. *Applications:* 1. Novel human TIMP-2 derived peptide sequences. 2. Novel human TIMP-2 derived peptide sequences with considerable anti-angiogenic activity in vivo. 3. Human TIMP-2 derived peptides with high anti-angiogenic activity that can be used for the treatment of several cancers. 4. Human TIMP-2 derived peptides with high anti-angiogenic activity that can be used for the treatment of several other angiogenesis associated diseases such as retinopathy and rheumatoid arthritis. *Market:* 1. 600,000 deaths from cancer related diseases estimated in 2006. 2. The technology platform involving novel anti-angiogenic cancer therapy technology has a potential market of more than 2 billion U.S. dollars. 3. The technology platform has additional market in treating several other clinical problems such as autoimmune diseases. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventors:* William G. Stetler-Stevenson and Dong-Wan Seo
(NCI)(Lead Inventor Web page: *http://ccr.cancer.gov/staff/staff.asp?profileid=5853* ) *Related Publications:* 1. DW Seo, *et al.* TIMP-2 mediated inhibition of angiogenesis: an MMP-independent mechanism. Cell 2003 Jul 25; 114(2):171-180. 2. WG Stetler-Stevenson, et al. Tissue inhibitor of metalloproteinases-2 (TIMP-2) mRNA expression in tumor cell lines and human tumor tissues. J Biol Chem. 1990 Aug 15; 265(23):13933-13938. 3. WG Stetler-Stevenson and DW Seo. TIMP-2: an endogenous inhibitor of angiogenesis. Trends Mol Med. 2005 Mar; 11(3):97-103. 4. DW Seo, et al. Shp-1 mediates the antiproliferative activity of tissue inhibitor of metalloproteinase-2 in human microvascular endothelial cells. J Biol Chem. 2006 Feb 10; 281(6):3711-3721. 5. H Chang, et al. TIMP-2 promotes cell spreading and adhesion via upregulation of RAP1 signaling. Biochem. Biophys. Res. Comm. 2006 Jul 7; 345(3):1201-1206. 6. J Oh, et al. TIMP-2 upregulates RECK expression via dephosphorylation of paxillin tyrosine residues 31 and 118. Oncogene 2006 Jul 13; 25(30):4230-4234. *Patent Status:* U.S. Provisional Application No. 60/728,146 filed 18 Oct 2005, entitled “Angio-inhibitory Peptides Derived from TIMP-2” (HHS Reference No. E-186-2005/0-US-01). *Licensing Status:* Available for exclusive and non-exclusive licensing. *Licensing Contact:* Thomas P. Clouse, J.D.; 301/435-4076; *clousetp@mail.nih.gov.* *Collaborative Research Opportunity:* The NCI Cell and Cancer Biology Branch is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize TIMP-2 derived anti-angiogenic peptides. Please contact Betty Tong at 301-496-0477 or *tongb@mail.nih.gov* for more information. Novel Chemoattractant-Based Toxins To Improve Vaccine Immune Responses for Cancer and Infectious Diseases *Description of Technology:* Cancer is one of the leading causes of death in United States and it is estimated that there will be more than half a million deaths caused by cancer in 2006. A major drawback of the current chemotherapy-based therapeutics is the cytotoxic side-effects associated with them. Thus there is a dire need to develop new therapeutic strategies with fewer side-effects. Immuno-therapy has taken a lead among the new therapeutic approaches. Enhancing the innate immune response of an individual has been a key approach for the treatment against different diseases such as cancer and infectious diseases. This technology involves the generation of novel chemoattractant toxins that deplete the T regulatory cells
(Treg)or other immunosuppressive or hyperactivated cells locally. Treg controls activation of immune responses by suppressing the induction of adaptive immune responses, particularly T cell responses. Immunosuppressive cells such as tumor infiltrating macrophages or NKT and other cells down regulate antitumor immune responses. The chemoattractant toxins consist of a toxin moiety fused with a chemokine receptor ligand, chemokines and other chemoattractants that enables specific targeting and delivery to the Treg cells. This technology is advantageous over the more harmful antibodies and chemicals that are currently used for the systemic depletion of Treg cells. The current technology can be used therapeutically in a variety of ways. They can be used together with vaccines to increase efficacy of the vaccine for the treatment of cancer, and can used to locally deplete Treg cells or other immuno suppressive cells to induce cytolytic cell responses at the tumor site or to eliminate chronic infectious diseases such as HIV and tuberculosis. *Applications:* 1. New chemoattractant based toxins targeted towards Treg cells. 2. New chemoattractant based toxins targeted towards immunosuppressive NKT, and macrophages. 3. New chemoattractant based toxins targeted towards local depletion of hyperactivated CD4 T cells to treat autoimmune diseases. 4. Chemoattractant based toxins depleting Treg cells or other immunosuppressive cells causing enhanced vaccine immune responses. 5. Novel immunotherapy by increasing vaccine efficacy against cancer and infectious diseases. *Market:* 1. 600,000 deaths from cancer related diseases estimated in 2006. 2. The technology platform involving novel chemo-attractant based toxins can be used to improve vaccine immune responses. The vaccine market is believed to reach $10bn in 2006. 3. The technology platform has additional market in treating several other clinical problems such as autoimmune diseases. *Development Status:* The technology is currently in the pre-clinical stage of development. *Inventors:* Arya Biragyn (NIA), Dolgor Bataar (NIA), *et al.* (Lead Inventor Web page: *http://www.grc.nia.nih.gov/branches/irp/abiragyn.htm* ). *Related Publications:* 1. Copy of manuscript from this technology can be provided once accepted for publication. 2. M Coscia, A Biragyn. Cancer immunotherapy with chemoattractant peptides. Semin Cancer Biol 2004 Jun; 14(3):209-218. 3. R Schiavo et al. Chemokine receptor targeting efficiently directs antigens to MHC class I pathways and elicits antigen-specific CD8+ T-cell responses. Blood 2006 Jun 15; 107 (12):4597-4605. Epub 2006 Mar 2, doi 10.1182/blood-2005-08-3207. *Patent Status:* U.S. Provisional Application No. 60/722,675 filed 30 Sep 2005, entitled “Methods and Compositions for Modulating Immune Tolerance” (HHS Reference No. E-027-2005/0-US-01). *Licensing Status:* Available for non-exclusive or exclusive licensing. *Licensing Contact:* Thomas P. Clouse, J.D.; 301/435-4076; *clousetp@mail.nih.gov.* *Collaborative Research Opportunity:* The NIA Laboratory of Immunology is seeking statements of capability or interest from parties interested in collaborative research to further develop, evaluate, or commercialize novel chemoattractant-based toxins. Please contact Betty Tong at 301-496-0477 or *tongb@mail.nih.gov* for more information. Dated: September 8, 2006. Steven M. Ferguson, Director, Division of Technology Development and Transfer, Office of Technology Transfer, National Institutes of Health. [FR Doc. E6-15294 Filed 9-14-06; 8:45 am] BILLING CODE 4140-01-P DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Center for Research Resources; Notice of Closed Meetings Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. Appendix 2), 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. *Name of Committee:* National Center for Research Resources Initial Review Group; Clinical Research Review Committee. *Date:* October 4-5, 2006. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Residence Inn Bethesda, 7335 Wisconsin Avenue, Bethesda, MD 20814. *Contact Person:* Mohan Viswanathan, PhD, Deputy Director, National Center for Research Resources, OR, National Institutes of Health, 6701 Democracy Blvd., Room 1084, MSC 4874, 1 Democracy Plaza, Bethesda, MD 20892-4874; 301-435-0829; *mv10f@nih.gov.* *Name of Committee:* National Center for Research Resources Special Emphasis Panel; CMRC-A *Date:* October 5, 2006. *Time:* 9 a.m. to 10 a.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892. (Telephone Conference Call). *Contact Person:* John R. Glowa, PhD, Scientific Review Administrator, Office of Review, National Center for Research Resources, 6701 Democracy Boulevard, Room 1078—MSC 4874, Bethesda, MD 20892-4874; 301.435.0807; *glowaj@mail.nih.gov.* *Name of Committee:* National Center for Research Resources Initial Review Group; Comparative Medicine Review Committee. *Date:* October 10-11, 2006. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Double Tree Rockville, 1750 Rockville Pike, Roosevelt Room, Rockville, MD 20852. *Contact Person:* John R. Glowa, PhD, Scientific Review Administrator, Office of Review, National Center for Research Resources, 6701 Democracy Boulevard, Room 1078—MSC 4874; Bethesda, MD 20892-4874; 301.435.0807; *glowaj@mail.nih.gov.* *Name of Committee:* National Center for Research Resources Special Emphasis Panel; GCRC and K23 SEP. *Date:* October 19-20, 2006. *Time:* 8 a.m. to 5 p.m. *Agenda:* To review and evaluate grant applications. *Place:* Gaithersburg Hilton, 620 Perry Parkway, Gaithersburg, MD 20877. *Contact Person:* Guo Zhang, PhD, Scientific Review Administrator, National Center for Research Resources/OR, National Institutes of Health, 6701 Democracy Boulevard, 1 Democracy Plaza, Rm. 1064, Bethesda, MD 20892-4874; 301-435-0812; *zhanggu@mail.nih.gov.* *Name of Committee:* National Center for Research Resources Special Emphasis Panel; RCMI Net Teleconference. *Date:* October 26, 2006. *Time:* 1 p.m. to 4 p.m. *Agenda:* To review and evaluate grant applications. *Place:* National Institutes of Health, One Democracy Plaza, 6701 Democracy Boulevard, Bethesda, MD 20892; (Telephone Conference Call). *Contact Person:* Guo Zhang, PhD, Scientific Review Administrator, Office of Review, National Center for Research Resources, National Institutes of Health, 6701 Democracy Boulevard, 1 Democracy Plaza, Rm. 1064, Bethesda, MD 20892;
(301)435-0812; *zhanggu@mail.nih.gov.* (Catalogue of Federal Domestic Assistance Program Nos. 93.306, Comparative Medicine; 93.333, Clinical Research; 93.371, Biomedical Technology; 93.389, Research Infrastructures, 93.306, 93.333, National Institutes of Health, HHS) Dated: September 8, 2006. Anna Snouffer, Acting Director, Office of Federal Advisory Committee Policy. [FR Doc. 06-7666 Filed 9-14-06; 8:45 am]
Connectionstraces to 10
16 references not yet in our index
  • 19 CFR 351
  • Pub. L. 104-13
  • 40 CFR 1506.9
  • Pub. L. 92-463
  • Pub. L. 109-148
  • 119 Stat. 2680
  • Pub. L. 109-149
  • 119 Stat. 2833
  • 45 CFR 74
  • 42 CFR 491.9
  • 42 CFR 424.123
  • 42 CFR 416.44
  • 45 CFR 164.512(a)(1)
  • 45 CFR 5
  • 21 CFR 14
  • 42 CFR 100.3
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Notices
Notice
C.F.R.§ 351.218
C.F.R.§ 351.222
C.F.R.§ 351.303
C.F.R.§ 351.216
U.S.C.§ 35
U.S.C.§ 3501
Fed. Reg.Notices
U.S.C.§ 300aa–10
U.S.C.§ 300aa–12
Cite19 CFR 351
Pub. L.Pub. L. 104-13
Cite40 CFR 1506.9
Cites 26 · showing 12Cited by 0 across 0 sources
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