Rules and Regulations. Final rule

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BILLING CODE 4910-13-M DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 30522; Amdt. No. 3193] Standard Instrument Approach Procedures; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This amendment amends Standard Instrument Approach Procedures (SIAPs) for operations at certain airports. These regulatory actions are needed because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, addition of new obstacles, or changes in air traffic requirements.

These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports. DATES: This rule is effective November 15, 2006. The compliance date for each SIAP is specified in the amendatory provisions. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of November 15, 2006. ADDRESSES: Availability of matter incorporated by reference in the amendment is as follows: *For Examination* — 1.

FAA Rules Docket, FAA Headquarters Building, 800 Independence Ave, SW., Washington, DC 20591; 2. The FAA Regional Office of the region in which affected airport is located; or 3. The National Flight Procedures Office, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or, 4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.* *For Purchase* —Individual SIAP copies may be obtained from: 1.

FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or 2. The FAA Regional Office of the region in which the affected airport is located. *By Subscription* —Copies of all SIAPs, mailed once every 2 weeks, are for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. FOR FURTHER INFORMATION CONTACT: Donald P. Pate, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address:

P.O. Box 25082, Oklahoma City, OK 73125) telephone:

(405)954-4164. SUPPLEMENTARY INFORMATION: This amendment to Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) amends Standard Instrument Approach Procedures (SIAPs). The complete regulatory description of each SIAP is contained in the appropriate FAA Form 8260, as modified by the the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), which is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and Section 97.20 of the Code of Federal Regulations. Materials incorporated by reference are available for examination or purchase as stated above. The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the **Federal Register** expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs, but refer to their graphic depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR sections, with the types and effective dates of the SIAPs. This amendment also identifies the airport, its location, the procedure identification and the amendment number. The Rule This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs. The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these chart changes to SIAPs, the TERPS criteria were applied to only these specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days. Further, the SIAPs contained in this amendment are based on the criteria contained in TERPS. Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866;

(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and

(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 97 Air traffic control, Airports, Incorporation by reference, and Navigation (Air). Issued in Washington, DC on November 3, 2006. James J. Ballough, Director, Flight Standards Service. Adoption of The Amendment Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, part 97, 14 CFR part 97, is amended by amending Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722. 2. Part 97 is amended to read as follows: By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, ISMLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows: * * * Effective Upon Publication FDC date State City Airport FDC No. Subject 10/19/06 ME PORTLAND PORTLAND INTL JETPORT 6/3879 ILS OR LOC RWY 11, AMDT 2. ILS RWY 11 (CAT II, III) AMDT 2. 10/20/06 WY KEMMERER KEMMERER MUNI 6/3940 RNAV

(GPS)RWY 34, ORIG. 10/24/06 PA PUNXSUTAWNEY PUNXSUTAWNEY MUNI 6/4227 RNAV

(GPS)RWY 25, ORIG. 10/27/06 TX CARTHAGE PANOLA COUNTY-SHARPE FIELD 6/4648 NDB OR GPS RWY 35, AMDT 1A. 10/27/06 LA LAFAYETTE LAFAYETTE REGIONAL 6/4649 ILS OR LOC RWY 22L, AMDT 4D. 10/27/06 OH COLUMBUS BOLTON FIELD 6/4656 ILS RWY 4, AMDT 4A. 10/30/06 AL MUSCLE SHOALS NORTHWEST ALABAMA REGIONAL 6/4773 ILS OR LOC RWY 29, AMDT 4. 10/31/06 CA NAPA NAPA COUNTY 6/4890 LOC RWY 36L, AMDT 2C. 10/31/06 OH TOLEDO TOLEDO EXPRESS 6/4929 ILS OR LOC RWY 7, AMDT 27. 10/31/06 OH DAYTON JAMES M COX DAYTON INTL 6/4930 ILS RWY 6L, AMDT 8. 10/31/06 OH DAYTON JAMES M COX DAYTON INTL 6/4931 ILS RWY 18, AMDT 9. 10/31/06 OH DAYTON JAMES M COX DAYTON INTL 6/4932 ILS RWY 24L, AMDT 8A. 10/31/06 OH DAYTON JAMES M COX DAYTON INTL 6/4934 ILS RWY 24R, AMDT 6. 10/31/06 OH DAYTON JAMES M COX DAYTON INTL 6/4936 ILS RWY 6L (CAT II), AMDT 8. 10/31/06 OH DAYTON JAMES M COX DAYTON INTL 6/4937 ILS RWY 6L (CAT III), AMDT 8. 10/31/06 GA VIDALIA VIDALIA REGIONAL 6/4940 ILS OR LOC/NDB RWY 24, ORIG. 10/31/06 OH CLEVELAND BURKE LAKEFRONT 6/4955 ILS RWY 24R, ORIG-C. 10/31/06 ME BANGOR BANGOR INTL 6/4962 ILS OR LOC RWY 33, AMDT 11. 10/31/06 AZ TUCSON TUCSON INTL 6/4964 RNAV

(GPS)RWY 11R, ORIG. 10/31/06 CA ARCATA/EUREKA ARCATA 6/4970 ILS OR LOC/DME RWY 32, AMDT 1B. 11/01/06 MO HIGGINSVILLE HIGGINSVILLE INDUSTRIAL MUNI 6/5020 RNAV

(GPS)RWY 34, ORIG. 11/01/06 MO HIGGINSVILLE HIGGINSVILLE INDUSTRIAL MUNI 6/5023 RNAV

(GPS)RWY 16, ORIG. 11/01/06 OH CLEVELAND CLEVELAND-HOPKINS INTL 6/5025 ILS OR LOC RWY 6R, AMDT 19B. 11/01/06 OH CLEVELAND CLEVELAND-HOPKINS INTL 6/5026 ILS RWY 6R (CAT II), AMDT 19B. 11/01/06 OH CLEVELAND CLEVELAND-HOPKINS INTL 6/5028 ILS RWY 6R (CAT III), AMDT 19B. 11/01/06 AK ANCHORAGE TED STEVENS ANCHORAGE INTL 6/5039 RNAV

(GPS)RWY 7L, AMDT 1. 11/01/06 AK BETHEL BETHEL 6/5040 ILS/DME RWY 18, AMDT 5A. 11/01/06 AK BETHEL BETHEL 6/5041 LOC/DME BC RWY 36, AMDT 5B. 11/01/06 AK FAIRBANKS FAIRBANKS INTL 6/5043 VOR OR TACAN RWY 19R, AMDT 1. 11/01/06 AZ TUCSON TUCSON INTL 6/5117 RNAV

(GPS)RWY 11R, ORIG. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5134 ILS RWY 7, AMDT 1. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5135 ILS RWY 1, AMDT 28A. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5136 ILS RWY 7 (CAT II) , AMDT 1. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5137 RNAV

(GPS)RWY 1, ORIG. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5138 ILS RWY 7 (CAT III) , AMDT 1. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5139 RNAV

(GPS)Z RWY 25, ORIG. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5140 RNAV

(GPS)Z RWY, 19 ORIG. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5141 LOC BC RWY 19, AMDT 15. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5142 RNAV

(GPS)RWY 7, ORIG. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5143 RADAR-1, AMDT 10. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5144 RNAV

(GPS)Y RWY 19, ORIG. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5145 RNAV

(GPS)Y RWY 25, ORIG. 11/01/06 IL CHICAGO/ ROCKFORD CHICAGO/ ROCKFORD INTL 6/5146 NDB RWY 1, AMDT 25C. [FR Doc. E6-19115 Filed 11-14-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF TRANSPORTATION Federal Aviation Administration 14 CFR Part 97 [Docket No. 30521 Amdt. No. 3192] Standard Instrument Approach Procedures, Weather Takeoff Minimums; Miscellaneous Amendments AGENCY: Federal Aviation Administration (FAA), DOT. ACTION: Final rule. SUMMARY: This amendment establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and/or Weather Takeoff Minimums for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, addition of new obstacles, or changes in air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports. DATES: This rule is effective November 15, 2006. The compliance date for each SIAP and/or Weather Takeoff Minimums is specified in the amendatory provisions. The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of November 15, 2006. ADDRESSES: Availability of matters incorporated by reference in the amendment is as follows: *For Examination* — 1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; 2. The FAA Regional Office of the region in which the affected airport is located; 3. The National Flight Procedures Office, 6500 South MacArthur Blvd., Oklahoma City, OK 73169, or; 4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to: *http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html.* *For Purchase* —Individual SIAP and Weather Takeoff Minimums copies may be obtained from: 1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or 2. The FAA Regional Office of the region in which the affected airport is located. *By Subscription* —Copies of all SIAPs and Weather Takeoff Minimums mailed once every 2 weeks, are for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402. FOR FURTHER INFORMATION CONTACT: Donald P. Pate, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) telephone:

(405)954-4164. SUPPLEMENTARY INFORMATION: This amendment to Title 14 of the Code of Federal Regulations, part 97 (14 CFR part 97), establishes, amends, suspends, or revokes SIAPs and/or Weather Takeoff Minimums. The complete regulatory description of each SIAP and/or Weather Takeoff Minimums is contained in official FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR part 97.20. The applicable FAA Forms are identified as FAA Forms 8260-3, 8260-4, 8260-5 and 8260-15A. Materials incorporated by reference are available for examination or purchase as stated above. The large number of SIAPs and/or Weather Takeoff Minimums, their complex nature, and the need for a special format make their verbatim publication in the **Federal Register** expensive and impractical. Further, airmen do not use the regulatory text of the SIAPs and/or Weather Takeoff Minimums but refer to their depiction on charts printed by publishers of aeronautical materials. Thus, the advantages of incorporation by reference are realized and publication of the complete description of each SIAP and/or Weather Takeoff Minimums contained in FAA form documents is unnecessary. The provisions of this amendment state the affected CFR sections, with the types and effective dates of the SIAPs and/or Weather Takeoff Minimums. This amendment also identifies the airport, its location, the procedure identification and the amendment number. The Rule This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP and/or Weather Takeoff Minimums as contained in the transmittal. Some SIAP and/or Weather Takeoff Minimums amendments may have been previously issued by the FAA in a Flight Data Center

(FDC)Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP, and/or Weather Takeoff Minimums amendments may require making them effective in less than 30 days. For the remaining SIAPs and/or Weather Takeoff Minimums, an effective date at least 30 days after publication is provided. Further, the SIAPs and/or Weather Takeoff Minimums contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPs and/or Weather Takeoff Minimums, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs and/or Weather Takeoff Minimums and safety in air commerce, I find that notice and public procedure before adopting these SIAPs and/or Weather Takeoff Minimums are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs and/or Weather Takeoff Minimums effective in less than 30 days. Conclusion The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) is not a “significant regulatory action” under Executive Order 12866;

(2)is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and

(3)does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. List of Subjects in 14 CFR Part 97 Air traffic control, Airports, Incorporation by reference, and Navigation (air). Issued in Washington, DC on November 3, 2006. James J. Ballough, Director, Flight Standards Service. Adoption of the Amendment Accordingly, pursuant to the authority delegated to me, under Title 14, Code of Federal Regulations, part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures and Weather Takeoff Minimums effective at 0901 UTC on the dates specified, as follows: PART 97—STANDARD INSTRUMENT APPROACH PROCEDURES 1. The authority citation for part 97 continues to read as follows: Authority: 49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722. 2. Part 97 is amended to read as follows: Effective 23 November 2006 Jonesville, VA, Lee County, RNAV

(GPS)RWY 7, Orig Jonesville, VA, Lee County, RNAV

(GPS)RWY 25, Orig Jonesville, VA, Lee County, Takeoff Minimums and Textual DP, Orig Effective 21 December 2006 Fort Myers, FL, Southwest Florida Intl, LOC RWY 5, Orig Effective 18 January 2007 Greensboro, AL, Greensboro Muni, RNAV

(GPS)RWY 18, Orig Greensboro, AL, Greensboro Muni, RNAV

(GPS)RWY 36, Orig Greensboro, AL, Greensboro Muni, NDB OR GPS RWY 36, Orig-B, CANCELLED Greensboro, AL, Greensboro Muni, Takeoff Minimums and Textual DP, Orig Gulkana, AK, Gulkana, RNAV

(GPS)RWY 15, Amdt 1 Gulkana, AK, Gulkana, RNAV

(GPS)RWY 33, Amdt 1 Gulkana, AK, Gulkana, VOR/DME RWY 15, Orig Gulkana, AK, Gulkana, VOR/DME RWY 33, Orig Gulkana, AK, Gulkana, VOR RWY 14, Amdt 7, CANCELLED Gulkana, AK, Gulkana, VOR RWY 32, Amdt 6A, CANCELLED Gulkana, AK, Gulkana, DF RWY 15, Amdt 2 Gulkana, AK, Gulkana, Takeoff Minimums & Textual DPs, Amdt 7 Orlando, FL, Kissimmee Gateway, ILS OR LOC RWY 15, Orig Louisville, KY, Bowman Field, RNAV

(GPS)RWY 24, Orig Louisville, KY, Bowman Field, GPS RWY 24, Orig-B, CANCELLED Brookhaven, MS, Brookhaven-Lincoln County, RNAV

(GPS)RWY 22, Orig Brookhaven, MS, Brookhaven-Lincoln County, VOR/DME-A, Amdt 9 Brookhaven, MS, Brookhaven-Lincoln County, NDB OR GPS RWY 22, Amdt 3, CANCELLED Great Falls, MT, Great Falls Intl, Takeoff Minimums and Textual DP, Orig Gastonia, NC, Gastonia Muni, RNAV

(GPS)RWY 21, Orig Gastonia, NC, Gastonia Muni, RNAV

(GPS)RWY 3, Amdt 1 Dayton, OH, Greene County—Lewis A Jackson Regional, RNAV

(GPS)RWY 7, Orig Dayton, OH, Greene County—Lewis A Jackson Regional, RNAV

(GPS)RWY 25, Orig Dayton, OH, Greene County—Lewis A Jackson Regional, NDB RWY 25, Amdt 1 Dayton, OH, Greene County—Lewis A Jackson Regional, GPS RWY 7, Orig-A, CANCELLED Dayton, OH, Greene County—Lewis A Jackson Regional, Takeoff Minimums and Textual DP, Amdt 1 Elk City, OK, Elk City Regional Business, RNAV

(GPS)RWY 17, Orig Elk City, OK, Elk City Regional Business, RNAV

(GPS)RWY 35, Orig Elk City, OK, Elk City Regional Business, NDB RWY 17, Amdt 5 Elk City, OK, Elk City Regional Business, VOR/DME RNAV RWY 17, Amdt 2A, CANCELLED Elk City, OK, Elk City Regional Business, GPS RWY 35, Orig, CANCELLED Elk City, OK, Elk City Regional Business, GPS RWY 17, Orig, CANCELLED Elk City, OK, Elk City Regional Business, Takeoff Minimums and Textual DP, Amdt 1 Fayetteville, TN, Fayetteville Muni, RNAV

(GPS)RWY 20, Orig Fayetteville, TN, Fayetteville Muni, SDF RWY 20, Amdt 4 Fayetteville, TN, Fayetteville Muni, GPS RWY 20, Orig-A, CANCELLED Olympia, WA, Olympia, VOR/DME RWY 35, Amdt 12 Olympia, WA, Olympia, VOR-A, Amdt 1 Olympia, WA, Olympia, RNAV

(GPS)RWY 35, Orig Olympia, WA, Olympia, RNAV

(GPS)RWY 17, Orig The FAA published an Amendment in Docket No. 30513, Amdt No. 3184 to Part 97 of the Federal Aviation Regulations (Vol 71, FR No. 179, Page 54404; dated September 15, 2006) under section 97.27, effective 23 November 2006, published in TL 06-21 are hereby RESCINDED as follows: Saratoga, WY, Shively Field, NDB-A, Amdt 1 Saratoga, WY, Shively Field, RNAV (GPS)-B, Orig [FR Doc. E6-19112 Filed 11-14-06; 8:45 am] BILLING CODE 4910-13-P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 203 and 205 [Docket Nos. 1992N-0297 (Formerly 92N-0297), 1988N-0258 (Formerly 88N-0258), 2006D-0226] Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203 Compliance Policy Guide and Guidance for Industry: Prescription Drug Marketing Act Pedigree Requirements Questions and Answers; Notice of Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice of availability of guidances. SUMMARY: The Food and Drug Administration

(FDA)is announcing the availability of a final Compliance Policy Guide

(CPG)160.900 entitled “Prescription Drug Marketing Act—Pedigree Requirements under 21 CFR Part 203” (PDMA CPG). This CPG describes how the agency intends to prioritize its enforcement efforts in the first year after the December 1, 2006, effective date of 21 CFR §§ 203.3(u) and 203.50. In addition, the FDA is announcing the availability of “Guidance for Industry: Prescription Drug Marketing Act

(PDMA)Pedigree Requirements Questions and Answers” (PDMA Q & A). The PDMA Q & A guidance is issued in response to the many questions received regarding the Prescription Drug Marketing Act

(PDMA)pedigree requirements. The two guidance documents explain FDA's current thinking on issues related to the pedigree requirements of the PDMA. DATES: The effective date for the PDMA CPG is December 1, 2006. The PDMA CPG expires December 1, 2007. The PDMA Q & A guidance is effective November 15, 2006. Submit written or electronic comments on the PDMA Q & A guidance or the PDMA CPG at any time. ADDRESSES: Submit written comments on the PDMA Q & A guidance or the PDMA CPG identified by the docket numbers found in the heading of this document by any of the following methods: *Electronic Submissions* Submit electronic comments in the following ways: • Federal eRulemaking Portal: *http://www.regulations.gov* . Follow the instructions for submitting comments. • Agency Web site: *http://www.fda.gov/dockets/ecomments* . Follow the instructions for submitting comments on the agency Web site. *Written Submissions* Submit written submissions in the following ways: • FAX: 301-827-6870. • Mail/Hand delivery/Courier [For paper, disk, or CD-ROM submissions]: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. To ensure more timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages you to continue to submit electronic comments by using the Federal eRulemaking Portal or the agency Web site, as described in the *Electronic Submissions* portion of this paragraph. *Instructions* : All submissions received must include the agency name and docket numbers for this rulemaking. All comments received may be posted without change to *http://www.fda.gov/ohrms/dockets/default.htm* , including any personal information provided. For additional information on submitting comments, see the “Comments” heading of the SUPPLEMENTARY INFORMATION section of this document. *Docket* : For access to the docket to read background documents or comments received, go to *http://www.fda.gov/ohrms/dockets/default.htm* and insert the docket numbers, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. FOR FURTHER INFORMATION CONTACT: Ilisa Bernstein, Office of the Commissioner, Office of Policy (HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-3360, or by e-mail *ilisa.bernstein@fda.hhs.gov* . SUPPLEMENTARY INFORMATION: I. Background A. Implementation of 21 CFR §§ 203.3(u) and 203.50 The PDMA, as modified by the Prescription Drug Amendments of 1992, amended sections 301, 303, 503, and 801 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 331, 333, 353, and 381) to establish, among other things, requirements related to the wholesale distribution of prescription drugs. A primary purpose of the PDMA is to increase safeguards to prevent the introduction and retail sale of substandard, ineffective, and counterfeit drugs in the U.S. drug supply chain. Section 503(e)(1)(A) of the Federal Food, Drug, and Cosmetic Act

(act)establishes the so-called “pedigree” requirement for prescription drugs. A drug pedigree is a statement of origin that identifies each prior sale, purchase, or trade of a drug, including the dates of those transactions and the names and addresses of all parties to them. Under the pedigree requirement, each person who is engaged in the wholesale distribution of a prescription drug in interstate commerce, who is not the manufacturer or an authorized distributor of record for that drug, must provide a pedigree for that drug to the person who receives the drug. The PDMA states that an authorized distributor of record is a wholesaler that has an “ongoing relationship” with a manufacturer to distribute that manufacturer's drug. However, the PDMA does not define “ongoing relationship.” In 1999, FDA published final regulations related to the PDMA (part 203 (21 CFR part 203)). The regulations were to take effect in December 2000. After publication of the 1999 final rule, the agency received comments objecting to the provisions in §§ 203.3(u) and 203.50. Section 203.3(u) defines “ongoing relationship” to include a written agreement between a manufacturer and a distributor. Section 203.50 specifies the fields of information that must be included in the drug pedigree, and states that the information must be traceable back to the first sale by the manufacturer. Based on concerns raised by various stakeholders, the agency delayed the effective date of §§ 203.3(u) and 203.50 several times. Most recently, in February 2004, FDA delayed the effective date of §§ 203.3(u) and 203.50 until December 1, 2006, in part because we were informed by stakeholders in the U.S. drug supply chain that the industry would voluntarily implement electronic track and trace technology by 2007. If widely adopted, this technology could create a de facto electronic pedigree (e-pedigree) documenting the sale of a drug product from its place of manufacture through the U.S. drug supply chain to the final dispenser. If properly implemented, an electronic record could thus meet the pedigree requirements in section 503(e)(1)(A) of the act. Based on a recent fact-finding effort by FDA to assess the use of e-pedigree across the supply chain, however, it appears that industry will not fully implement track and trace technology by 2007. As a result of this fact finding, FDA published a notice in the **Federal Register** on June 14, 2006 (71 FR 34249), announcing that it does not intend to delay the effective date of §§ 203.3(u) and 203.50 beyond December 1, 2006. Thus, these provisions defining “ongoing relationship” and setting forth requirements regarding the information that must appear in pedigrees will go into effect as of December 1, 2006. As part of its June 14, 2006, announcement, FDA also issued and requested comment on draft Compliance Policy Guide 160.900 entitled “Prescription Drug Marketing Act Pedigree Requirements under 21 CFR Part 203.” B. PDMA Compliance Policy Guide We are issuing the final PDMA CPG, which describes how we plan to prioritize our enforcement efforts during the first year in which §§ 203.3(u) and 203.50 are effective. This PDMA CPG lists factors that FDA field personnel are expected to consider in prioritizing FDA's pedigree related enforcement efforts. Consistent with our risk-based approach to the regulation of pharmaceuticals, utilizing these factors will focus our efforts on drug products that are most vulnerable to counterfeiting and diversion or that are otherwise involved in illegal activity. The priorities described in the PDMA CPG reflect a phased-in type approach to the enforcement of the previously stayed pedigree provisions. The PDMA CPG will expire December 1, 2007. By providing guidance on the types of drugs that are currently of greatest concern to FDA, we believe that wholesale distributors will have a better idea of where and how to focus their initial energies as they implement systems and approaches to come into complete compliance with 21 CFR part 203. FDA is issuing this PDMA CPG as a level 1 guidance consistent with FDA's good guidance practices (21 CFR § 10.115). We note that guidance documents are not binding on FDA or industry, and, under appropriate circumstances, the agency may initiate regulatory action, including criminal prosecution, for violations of the pedigree requirements. C. Guidance for Industry: Prescription Drug Marketing Act Pedigree Requirements Questions and Answers We are also issuing the PDMA Q & A, which represents FDA's current thinking on several issues regarding the PDMA pedigree requirements. It addresses numerous questions that FDA received as comments to the PDMA CPG docket, as well as through e-mail and other communications, regarding the PDMA pedigree requirements. The questions and answers in the guidance address issues pertaining to manufacturers, wholesale distributors, pharmacies, and other entities affected by the PDMA pedigree requirements. FDA is issuing the PDMA Q & A as a level 1 guidance consistent with FDA's good guidance practices (21 CFR § 10.115). Given that the relevant PDMA pedigree provisions will go into effect as of December 1, 2006, FDA is implementing the PDMA Q&A immediately, in accordance with § 10.115(g)(2) (21 CFR 10.115(g)(2)), because the agency has determined that prior public input is not feasible or appropriate. As noted, the pedigree requirements set forth in §§ 203.3(u) and 203.50, which had been stayed on several occasions, will apply to prescription drug products as of December 1, 2006. Promptly clarifying FDA's current thinking on the questions in the guidance should facilitate industry's compliance with the PDMA pedigree requirements. Under § 10.115(g), FDA is opening a docket on the PDMA Q & A, and we invite interested persons to submit comments and questions. FDA intends to review the comments and questions and to revise the PDMA Q & A when appropriate, using the question and answer format in the PDMA Q & A guidance. For purposes of transparency, efficiency, and clarity, the agency believes that, at the present time, it is important to maintain FDA's written responses to the significant questions concerning the PDMA pedigree requirements in a single guidance document that is periodically updated as the agency receives and responds to additional questions. We also intend to use the following four indicators to help users of the guidance identify future additions or revisions:

(1)The updated guidance will be identified as a revision of the previously issued document,

(2)the revision date of the guidance will appear on its cover,

(3)the edition number of the guidance will be included in its title, and

(4)questions and answers that have been added to the guidance, or prior answers that have been in any way modified, will be identified as such in the body of the guidance. The PDMA CPG and PDMA Q & A guidance represent the agency's current thinking on issues related to the PDMA pedigree requirements. The guidances do not create or confer any rights for or on any person and do not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations. II. Electronic Access An electronic version of the PDMA CPG is available on the Internet at *http://www.fda.gov/ora* under “Compliance Reference”. An electronic version of the PDMA Q & A guidance is available at *http://www.fda.gov/pdma* . III. Comments Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding the PDMA Q & A guidance or PDMA CPG at any time. 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 and the guidance may be seen in the Division of Dockets management between 9 a.m. and 4 p.m., Monday through Friday. Dated: November 8, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06-9211 Filed 11-13-06; 8:45 am]

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