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Code · REGISTER · 2007-06-19 · Food and Drug Administration, HHS · Notices

Notices. Notice

5,570 words·~25 min read·/register/2007/06/19/07-2991

A research copy — for the controlling text, always check the official state or federal source. Not legal advice.

BILLING CODE 4184-01-M DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Cellular, Tissue, and Gene Therapies Advisory Committee; Notice of Meeting AGENCY: Food and Drug Administration, HHS. ACTION: Notice. This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). At least one portion of the meeting will be closed to the public. *Name of Committee* : Cellular, Tissue, and Gene Therapies Advisory Committee. *General Function of the Committee* :
To provide advice and recommendations to the agency on FDA's regulatory issues. *Date and Time* : The meeting will be held by teleconference on July 26, 2007 from 11 a.m. to approximately 3:15 p.m. *Location* : National Institutes of Health, Bldg. 29B, Conference rms. A/B, 9000 Rockville Pike, Bethesda, MD. This meeting will be held by teleconference. The public is welcome to attend the meeting at the specified location. A speakerphone will be provided at the specified location for public participation in the meeting.
Important information about transportation and directions to the NIH campus, parking, and security procedures is available on the Internet at *http://www.nih.gov/about/visitor/index.htm* . Visitors must show two forms of identification, one of which must be a government-issued photo identification such as a Federal employee badge, driver's license, passport, green card, etc. If you are planning to drive to and park on the NIH campus, you must enter at the South Dr. entrance of the campus which is located on Wisconsin Ave.
(the Medical Center Metro entrance), and allow extra time for vehicle inspection. Detailed information about security procedures is located at *http://www.nih.gov/about/visitorsecurity.htm* . Due to the limited available parking, visitors are encouraged to use public transportation. *Contact Person* : Gail Dapolito or Danielle Cubbage, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, Rockville, MD, 20852, 301-827-0314, or FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area), code 3014512389.
Please call the Information Line for up-to-date information on this meeting. A notice in the **Federal Register** about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency's Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting. *Agenda* : On July 26, 2007, the committee will meet in open session to hear updates of research programs in:
(1)The Division of Therapeutic Proteins and the Division of Monoclonal Antibodies, Office of Biotechnology Products, Center for Drug Evaluation and Research, FDA and
(2)the Division of Cellular and Gene Therapies, Office of Cellular, Tissue, and Gene Therapies, Center for Biologics Evaluation and Research, FDA. FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA's Web site after the meeting. Background material is available at *http://www.fda.gov/ohrms/dockets/ac/acmenu.htm* , click on the year 2007 and scroll down to the appropriate advisory committee link. *Procedure* : On July 26, 2007, from 11 a.m. to approximately 2 p.m., the meeting is open to the public. 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 July 12, 2007. Oral presentations from the public will be scheduled between approximately 1 p.m. and 2 p.m. 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 July 18, 2007. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by July 19, 2007. *Closed Committee Deliberations* : On July 26, 2007, from approximately 2:15 p.m. to 3:30 p.m., the meeting will be closed to permit discussion where disclosure would constitute a clearly unwarranted invasion of personal privacy (5 U.S.C. 552b(c)(6)). The committee will discuss reports of intramural research programs and make recommendations regarding personnel staffing decisions. Persons attending FDA's advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Gail Dapolito at least 7 days in advance of the meeting. Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2). Dated: June 11, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-11728 Filed 6-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2007N-0195] Science Board to the Food and Drug Administration; Amendment of Notice; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration is correcting a notice that appeared in the **Federal Register** of June 7, 2007 (72 FR 31587). The document announced an amendment to the notice of meeting of the Science Board to the Food and Drug Administration. The meeting was originally announced in the **Federal Register** of May 21, 2007 (72 FR 28499). The document was published with an incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy and Planning (HF-27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-7010. SUPPLEMENTARY INFORMATION: In FR Doc. 07-2829, appearing on page 31587 in the **Federal Register** of Thursday, June 7, 2007, the following correction is made: 1. On page 31587, in the first column, in the heading of the document, “[Docket No. 2007N-0208]” is corrected to read “[Docket No. 2007N-0195]”. Dated: June 11, 2007. Randall W. Lutter, Associate Commissioner for Policy and Planning. [FR Doc. E7-11727 Filed 6-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. 2006D-0012] Guidance for Industry and Food and Drug Administration Staff; Pharmacogenetic Tests and Genetic Tests for Heritable Markers; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration
(FDA)is announcing the availability of the guidance document entitled “Pharmacogenetic Tests and Genetic Tests for Heritable Markers.” This document is intended to provide guidance on preparing and reviewing premarket approval applications
(PMAs)and 510(k) submissions for pharmacogenetic and other genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests). DATES: Submit written or electronic comments on this guidance at any time. General comments on agency guidance documents are welcome at any time. ADDRESSES: Submit written requests for single copies of the guidance document entitled “Pharmacogenetic Tests and Genetic Tests for Heritable Markers” to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 20850. Send one self-addressed adhesive label to assist that office in processing your request, or fax your request to 240-276-3151. You may also obtain the guidance by mail by calling the Center for Biologics Evaluation and Research at 1-800-835-4709 or 301-827-1800, or by faxing your request to 301-443-8818. See the SUPPLEMENTARY INFORMATION section for information on electronic access to the guidance. Submit written comments concerning this guidance to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to *http://www.fda.gov/dockets/ecomments* . Identify comments with the docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Robert Becker, Center for Devices and Radiological Health (HFZ-440), Food and Drug Administration, 9200 Corporate Blvd., Rockville, MD 20850, 240-276-0493, ext. 212. *For use of the guidance in relation to applications to CBER contact* : Stephen M. Ripley, Center for Biologics Evaluation and Research (HFM-17), Food and Drug Administration, 1401 Rockville Pike, suite 200N, Rockville, MD 20852-1448, 301-827-6210. *For use of the guidance in relation to applications to CDER contact* : Felix Frueh, Office of Clinical Pharmacology and Biopharmaceutics (HFD-850), 10903 New Hampshire Ave., Silver Spring, MD 20993, 301-796-1530. SUPPLEMENTARY INFORMATION: I. Background The draft of this guidance document was published in the **Federal Register** of February 9, 2006 (71 FR 6779). The guidance provides recommendations on preparing and reviewing PMAs and 510(k) submissions for pharmacogenetic and other human genetic tests, whether testing is for single markers or for multiple markers simultaneously (multiplex tests). FDA received several sets of comments on the guidance and considered all comments. The guidance was revised where needed to provide additional clarification. II. Significance of Guidance This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on pharmacogenetic tests and genetic tests for heritable markers. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations. III. Electronic Access Persons interested in obtaining a copy of the guidance may do so by using the Internet. To receive “Pharmacogenetic Tests and Genetic Tests for Heritable Markers” you may either send an e-mail request to *dsmica@fda.hhs.gov* to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1594 to identify the guidance you are requesting. CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, **Federal Register** reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at *http://www.fda.gov/cdrh* . Search capabilities for guidance documents are available at *http://www.fda.gov/cdrh/guidance.html* (for CDRH guidances) and *http://www.fda.gov/cber/guidelines.htm* (for CBER guidances). Guidance documents are also available on the Division of Dockets Management Internet site at *http://www.fda.gov/ohrms/dockets* . IV. Paperwork Reduction Act of 1995 This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget
(OMB)under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807, subpart E, have been approved under OMB control number 0910-0120; the collections of information in 21 CFR part 814, have been approved under OMB control number 0910-0231; and the collections of information in 21 CFR parts 801 and 809 have been approved under OMB control number 0910-0485. V. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Dated: May 23, 2007. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. E7-11817 Filed 6-18-07; 8:45 am] BILLING CODE 4160-01-S DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5117-N-48] Notice of Submission of Proposed Information Collection to OMB; Restriction on Assistance to Noncitizens AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget
(OMB)for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. Section 214 of the Housing and Community Development Act of 1980, as amended, prohibits HUD from making financial assistance available for noncitizens, unless they meet one of the categories of eligible immigration status specified in Section 214. Prior to being admitted, all eligible noncitizens younger than age 62 must sign a declaration of their status and a verification consent form and provide their original Immigration and Naturalization Service
(INS)documentation. DATES: *Comments Due Date:* July 19, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2501-0014) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Departmental Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail *Lillian_L._Deitzer@HUD.gov* or telephone
(202)708-2374. This is not a toll-free number. Copies of available documents submitted to OMB may be obtained from Ms. Deitzer or from HUD's Web site at *http://www5.hud.gov:63001/po/i/icbts/collectionsearch.cfm.* SUPPLEMENTARY INFORMATION: This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to:
(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This notice also lists the following information: *Title of Proposal:* Restriction on Assistance to Noncitizens. *OMB Approval Number:* 2501-0014 *Form Numbers:* HUD-9886, HUD-9887. *Description of the Need for the Information and Its Proposed Use:* Section 214 of the Housing and Community Development Act of 1980, as amended, prohibits HUD from making financial assistance available for noncitizens, unless they meet one of the categories of eligible immigration status specified in Section 214. Prior to being admitted, all eligible noncitizens younger than age 62 must sign a declaration of their status and a verification consent form and provide their original Immigration and Naturalization Service
(INS)documentation. *Frequency of Submission:* On occasion, Annually. Number of respondents Annual responses × Hours per response = Burden hours Reporting Burden 2,886,392 3.74 .0333 360,214 *Total Estimated Burden Hours:* 360,214. *Status:* Extension of a currently collection. Authority: Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended. Dated: June 12, 2007. Lillian L. Deitzer, Departmental Paperwork Reduction Act Officer, Office of the Chief Information Officer. [FR Doc. E7-11745 Filed 6-18-07; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5117-N-49] Notice of Submission of Proposed Information Collection to OMB; Federal Labor Standards Questionnaire(s) Complaint Intake Form AGENCY: Office of the Chief Information Officer, HUD. ACTION: Notice. SUMMARY: The proposed information collection requirement described below has been submitted to the Office of Management and Budget
(OMB)for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal. The information is used by HUD to fulfill its obligation to enforce Federal labor standards provisions, especially to act upon allegations of labor standards violations. DATES: *Comments Due Date:* July 19, 2007. ADDRESSES: Interested persons are invited to submit comments regarding this proposal. Comments should refer to the proposal by name and/or OMB approval Number (2501-0018) and should be sent to: HUD Desk Officer, Office of Management and Budget, New Executive Office Building, Washington, DC 20503; fax: 202-395-6974. FOR FURTHER INFORMATION CONTACT: Lillian Deitzer, Departmental Reports Management Officer, QDAM, Department of Housing and Urban Development, 451 Seventh Street, SW., Washington, DC 20410; e-mail *Lillian_L._Deitzer@HUD.gov* or telephone
(202)708-2374. This is not a toll-free number. Copies of available documents submitted to OMB may be obtained from Ms. Deitzer or from HUD's Web site at *http://www5.hud.gov:63001/po/i/icbts/collectionsearch.cfm.* SUPPLEMENTARY INFORMATION: This notice informs the public that the Department of Housing and Urban Development has submitted to OMB a request for approval of the information collection described below. This notice is soliciting comments from members of the public and affecting agencies concerning the proposed collection of information to:
(1)Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility;
(2)Evaluate the accuracy of the agency's estimate of the burden of the proposed collection of information;
(3)Enhance the quality, utility, and clarity of the information to be collected; and
(4)Minimize the burden of the collection of information on those who are to respond; including through the use of appropriate automated collection techniques or other forms of information technology, e.g., permitting electronic submission of responses. This notice also lists the following information: *Title of Proposal:* Federal Labor Standards Questionnaire(s) Complaint Intake Form. *OMB Approval Number:* 2501-0018. *Form Numbers:* HUD-4730, HUD-4730-E, HUD-4730-SP, HUD-4731. *Description of the Need for the Information and Its Proposed Use:* The information is used by HUD to fulfill its obligation to enforce Federal labor standards provisions, especially to act upon allegations of labor standards violations. *Frequency of Submission:* On occasion. Number of respondents Annual responses × Hours per response = Burden hours Reporting Burden 2,500 1 0.5 1,250 *Total Estimated Burden Hours:* 1,250. *Status:* Extension of a currently collection. Authority: Section 3507 of the Paperwork Reduction Act of 1995, 44 U.S.C. 35, as amended. Dated: June 12, 2007. Lillian L. Deitzer, Departmental Paperwork Reduction Act Officer, Office of the Chief Information Officer. [FR Doc. E7-11746 Filed 6-18-07; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5076-D-15] Redelegation of Authority to the Director of the HUD Office of Healthy Homes and Lead Hazard Control Regarding Lead-Based Paint Enforcement AGENCY: Office of the Assistant Secretary for Housing—Federal Housing Commissioner, HUD. ACTION: Notice of redelegation of authority. SUMMARY: This notice redelegates to the Director of the Office of Healthy Homes and Lead Hazard Control authority presently residing with the Assistant Secretary for Housing—Federal Housing Commissioner or the Assistant Secretary's designee under 24 CFR 30.45 and 30.68 with respect to enforcement of lead-based paint requirements. These lead-based paint regulations, which are set out in 24 CFR part 35, subparts B, G, H, and R, require the notification, evaluation, and reduction of lead-based paint hazards in
(1)multifamily residential properties for which HUD is the owner of the mortgage or for which a lender receives mortgage insurance, including non-residential properties being converted to multifamily residential properties and
(2)multifamily residential properties for which the owner receives project-based housing assistance. DATES: *Effective Date:* June 8, 2007. FOR FURTHER INFORMATION CONTACT: Matthew Ammon, Deputy Director, Office of Healthy Homes and Lead Hazard Control, Department of Housing and Urban Development, 451 Seventh Street, SW., Room 8236, Washington, DC 20410-3000; telephone
(202)755-1785, extension 4337 (this is not a toll-free number). Speech- or hearing-impaired individuals may access this number through TTY by calling the toll-free Federal Information Relay Service at
(800)877-8339. SUPPLEMENTARY INFORMATION: HUD regulations at 24 CFR part 35, subparts B through R, set out general lead-based paint requirements for all federally-assisted pre-1978 housing. Specifically, subparts B and R set forth general requirements applying to all HUD programs and subparts G and H describe the procedures for notification, evaluation, and reduction of lead-based paint hazards in
(1)multifamily residential properties for which HUD is the owner of the mortgage or for which a lender receives mortgage insurance, including non-residential properties being converted to multifamily residential properties and
(2)multifamily residential properties for which an owner receives project-based housing assistance, respectively. HUD regulations at 24 CFR 30.45 and 30.68 authorize the Assistant Secretary for Housing—Federal Housing Commissioner, or the Assistant Secretary's designee, to initiate civil money penalty actions for violations of section 537(c)(1)(B) of the National Housing Act (12 U.S.C. 1735f-15(c)(1)(B)) and for violations of Section 8 of the United States Housing Act of 1937 (42 U.S.C. 1437f), including the failure to provide decent, safe, and sanitary housing, as set out by 24 CFR 5.703. Pursuant to this authority, the Assistant Secretary for Housing—Federal Housing Commissioner redelegates to the Director of the Office of Healthy Homes and Lead Hazard Control authority to initiate civil money penalty actions pursuant to 24 CFR 30.45 and 30.68 against a property owner who fails to provide information documenting compliance with or fails to comply with HUD regulations that require the notification, evaluation, and reduction of lead-based paint hazards in
(1)multifamily residential properties for which HUD is the owner of the mortgage or for which a lender receives mortgage insurance, including non-residential properties being converted to multifamily residential properties and
(2)multifamily properties for which an owner receives project-based housing assistance as set out in 24 CFR part 35, subparts B, G, H, and R. Accordingly, the Assistant Secretary for Housing—Federal Housing Commissioner hereby retains and redelegates authority as follows: I. Redelegation of Authority The Director of the Office of Healthy Homes and Lead Hazard Control is hereby authorized to initiate a civil money penalty action pursuant to and within the scope of 24 CFR 30.45 and 30.68 against property owners who fail to provide information documenting compliance with or fail to comply with HUD regulations that require the notification, evaluation, and reduction of lead-based paint hazards in
(1)multifamily residential properties for which HUD is the owner of the mortgage or for which a lender receives mortgage insurance, including non-residential properties being converted to multifamily residential properties and
(2)multifamily residential properties for which an owner receives project-based housing assistance as set out in 24 CFR part 35, subparts B, G, H, and R. II. Authority To Redelegate The Director of the Office of Healthy Homes and Lead Hazard Control is not authorized to redelegate the authority described herein. III. Revocation The Assistant Secretary for Housing—Federal Housing Commissioner may revoke the authority authorized herein, in whole or in part, at any time. Dated: June 8, 2007. Brian D. Montgomery, Assistant Secretary for Housing—Federal Housing Commissioner. [FR Doc. E7-11747 Filed 6-18-07; 8:45 am] BILLING CODE 4210-67-P DEPARTMENT OF THE INTERIOR Minerals Management Service Notice of the Annual Price Threshold Determination AGENCY: Minerals Management Service (MMS), Interior. ACTION: Notice of annual price threshold determination and annual average oil and gas market price calculations, along with their effects for the Gulf of Mexico royalty relief programs. SUMMARY: This notice provides the official MMS documentation of which Gulf of Mexico price thresholds have been exceeded by annual market prices for oil or gas, by lease vintage, for calendar year 2006. This notice also explains in detail how MMS calculates the annual oil and gas prices and applicable price thresholds used to determine whether royalty relief applies in calendar year 2006 for our various deepwater and deep depth royalty relief programs. FOR FURTHER INFORMATION CONTACT: Marshall Rose, Chief, Economics Division at
(703)787-1536. SUPPLEMENTARY INFORMATION: By various laws (Outer Continental Shelf Lands Act, Deep Water Royalty Relief Act, Energy Policy Act) and regulations (30 CFR 203.47, 203.54, 203.78, 260.110, and 260.122), MMS has authority to impose price thresholds for royalty relief. As prescribed in applicable regulations or lease terms, notwithstanding any provisions for royalty relief, companies are required to pay royalties for those calendar years when annual average New York Mercantile Exchange (NYMEX) market prices for oil or gas exceed the adjusted price thresholds levels. As a courtesy, MMS tracks, calculates, and posts on its website a variety of relevant information about applicable oil and gas prices and the price threshold levels to be used in determining whether a particular lease continues to be eligible for deep gas, deep water, or other royalty relief. The information contained in this published notice was posted on MMS Web site previously. The following table represents the official MMS price threshold and market price calculation determinations made for calendar year 2006. Any subsequent inflation adjustments or market price adjustments will not affect these official results or their implication for royalty relief on the designated categories of leases. Applicable Price Thresholds and Market Prices for Calendar Year 2006 Product Lease vintage (sales held in) Annual average NYMEX price ($/bbl or $/mmbtu) Adjusted price threshold level ($/bbl or $/mmbtu) Royalty relief suspended Deepwater oil Before 1996; 1996-1997; 2000; 2002-3/2004 $66.22 $35.75 Yes Deepwater oil 2001 66.22 32.06 Yes Deepwater oil 8/2004-2006 66.22 41.36 Yes Deepwater gas Before 1996; 1996-1997; 2000; 2002-3/2004 6.99 4.47 Yes Deepwater gas 2001 6.99 4.00 Yes Deepwater gas 8/2004-2006 6.99 6.88 Yes Deep gas 3/2001 6.99 4.00 Yes Deep gas 8/2001-2003 6.99 5.72 Yes Deep gas 2004-2006 6.99 9.88 No Deep gas Reg 30 CFR 203.47 6.99 9.88 No bbl = barrel, mmbtu = million British Thermal Units. Technical Documentation The data and methodology used for making the 2006 calculations and determinations are discussed below. This same information for all years since 1996 is available at the Economics Division Web site *http://www.mms.gov/econ/DWRRAPrice1.htm* . Additional information and notes about understanding this Web site are included at the end of this notice. Methodology for Calculation of the Actual Annual Average NYMEX Nearby Delivery Price 1. We use the price for the nearby delivery month. That is, the price for the first contract or earliest month that you can get the delivery/inventory for buying and selling today's product. For example, on September 1, 2006, the nearby delivery month was October 2006. There are prices for other delivery months that can be bought and sold on September 1, 2006, such as November 2006, December 2006, etc., but the “nearby delivery month” would be October 2006. However, the nearby delivery month is not always the next month because trading days may differ for oil and gas futures. For example, on September 28, 2006, the nearby delivery month was November 2006. 2. The daily NYMEX closing price is listed as the settle price at the end of business trading hours for each commodity. These are listed at *http://www.nymex.com* and also summarized at *http://www.oilnergy.com* . 3. The daily closing average is used to calculate the monthly average. For holidays and weekends, we use the previous business day's closing average. For example, Table A illustrates the calculation of the average NYMEX oil price for the month of September 2006. ( **Note** —this methodology is different from the Minerals Revenue Management's Royalty In-Kind Program that excludes weekends and holidays.) Our analysis indicates that inclusion or exclusion of weekends and holidays does not bias the annual average price calculation in either direction. We chose to include the weekends and holidays, as highlighted in Table A, because our source summarizes the monthly price data with the inclusion. Table A.—Example of Monthly Average Price Calculation Day Date Daily closing price ($/bbl) Day Date Daily closing price ($/bbl) Friday 9/1/2006 $69.19 Saturday 9/16/2006 $63.33 Saturday 9/2/2006 69.19 Sunday 9/17/2006 63.33 Sunday 9/3/2006 69.19 Monday 9/18/2006 63.80 Monday (Holiday) 9/4/2006 69.19 Tuesday 9/19/2006 61.66 Tuesday 9/5/2006 68.60 Wednesday 9/20/2006 60.46 Wednesday 9/6/2006 67.50 Thursday 9/21/2006 61.59 Thursday 9/7/2006 67.32 Friday 9/22/2006 60.55 Friday 9/8/2006 66.25 Saturday 9/23/2006 60.55 Saturday 9/9/2006 66.25 Sunday 9/24/2006 60.55 Sunday 9/10/2006 66.25 Monday 9/25/2006 61.45 Monday 9/11/2006 65.61 Tuesday 9/26/2006 61.01 Tuesday 9/12/2006 63.76 Wednesday 9/27/2006 62.96 Wednesday 9/13/2006 63.97 Thursday 9/28/2006 62.76 Thursday 9/14/2006 63.22 Friday 9/29/2006 62.91 Friday 9/15/2006 63.33 Saturday 9/30/2006 62.91 Average 64.29 4. The monthly average is used to calculate the annual average. For example, Table B illustrates the calculation of the NYMEX oil price for 2006. The calculation for the year-to-date average consists of the monthly averages so far in the year. The dollar amount of the result is rounded to the nearest tenth decimal point (i.e., cents). Table B. Example of Annual Average Price Calculation Month Average closing price ($/bbl) January $65.33 February 62.02 March 62.89 April 70.11 May 70.86 June 71.03 July 74.45 August 73.11 September 64.29 October 59.22 November 59.14 December 62.22 Average 66.22 Methodology for Calculation of the Applicable Oil and Natural Gas Price Thresholds 1. The price thresholds are estimates until they are locked in for a calendar year based on the most current inflation data available after the close of the year. In conjunction with the calculation of the annual market prices for oil and gas above, once the price thresholds are locked in, MMS makes an official determination regarding whether these market prices have exceeded the applicable price thresholds for the calendar year for a given vintage of lease and royalty relief program. After this official MMS determination is made, any subsequent revisions in the underlying source of the inflation figures will not affect the locked-in price thresholds or the determination of eligibility for royalty relief for that calendar year. 2. The source for inflation data is the Department of Commerce, Bureau of Economic Analysis
(BEA)*http://www.bea.gov.* U.S. Economic Accounts—Gross Domestic Product (GDP). National Income and Products Account
(NIPA)Table 1.1.9. The 4th quarter implicit price deflator is usually not available from BEA until March of the subsequent calendar year. 3. The implicit price deflator for GDP is used to calculate the applicable annual inflation rate, as illustrated in Table C. The deflator from the applicable year is divided by the deflator from the previous year and subtracted by one. For example, the inflation rate used to set the 2003 price threshold is calculated as {(106.40/104.19) − 1 = 2.1%} Table C.—Inflation Rates (Current and Locked-In) [Derived from BEA data] Calendar year Implicit price deflator for GDP ( base=1996) Implicit price deflator for GDP (base=2000) Current annual inflation rate Locked-in annual inflation rate 1994 96.01 1995 98.10 1996 100.00 1997 101.95 1998 103.20 1999 104.65 2000 107.04 100.00 2001 102.40 2.2 2.3 2002 104.19 1.2 1.2 2003 106.40 2.1 1.6 2004 109.43 2.8 2.3 2005 112.74 3.0 3.5 2006 116.04 2.9 2.9 4. Because price thresholds are fixed for previous years, the current inflation rate displayed in Table C above may not correspond precisely to the rate actually employed to calculate previous price thresholds. For example, the GDP deflator posted on the BEA Web site in March 2007 shows an inflation rate for 2004 of 2.8 percent. However, back in March 2005, when the 2004 price threshold was locked-in, the BEA Web site showed an inflation rate of 2.3 percent, resulting in a change for the deepwater oil price threshold for lease vintage 1996-2000*; 2002-3/2004*, as shown in the Deepwater Table on the Web site, from $32.80/bbl in 2003 to $33.55/bbl in 2004. Note that the figures that were shown on the BEA Web site in March of each year would be consistent with the adjustments made in the price thresholds from year to year. Rounding explains any remaining small differences between calculated locked-in inflation rates and those rates depicted on the MMS Web site. Therefore, to replicate the calculation for previous price thresholds, use the locked-in inflation rate. To replicate the calculation for the estimated price threshold, prior to March of the subsequent year, use the current inflation rate. Additional Information and Notes About the Web Site 1. The MMS will estimate the average market price at which oil or gas would have to sell during the remainder of the calendar year for the estimated price threshold to be exceeded for that year. If that estimated market price is shown in the table as a negative number, the average price at which oil or gas would have to be sold during the rest of the calendar year as of that time is guaranteed to exceed the estimated price threshold for the calendar year. 2. The bold font shown for selected actual annual market prices indicates years in which at least some leases were not eligible for royalty relief because actual prices exceeded the applicable price thresholds set for those leases. For example, in calendar year 2004, the actual average price of natural gas of $6.18 (per million Btu) exceeded the shallow water, deep natural gas price threshold levels of $3.76 for leases issued in Sale 178 (2001), and $5.37 for leases issued in all other Gulf of Mexico Sales held from 2001-2003 that did not exercise the option to switch terms offered under 30 CFR 203.48. 3. Production generated royalty-free under the deep gas program counts against the remaining royalty suspension volume, with one exception. That exception involves production from March 1, 2004, through May 2, 2004, from deep wells that qualified for royalty suspension under 30 CFR 203.40 through 48 (see **Federal Register** , Volume 69, Number 84, page 24055). 4. Regulations pertaining to price thresholds include 30 CFR 203.47, 203.54, 203.78, 260.110, and 260.122. Dated: May 22, 2007. Chris C. Oynes, Associate Director for Offshore Minerals Management. [FR Doc. 07-2991 Filed 6-18-07; 8:45 am]
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