June 2007

Docket No. 2007N-0208.  Interim Melamine and Melamine Analogues Safety/Risk Assessment; Availability.  Pages  30014-30015 [FR Doc. 07-2679 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due June 29, 2007

July 2007

Docket No. 2007D-0135.  Guidance for Industry on Testing of Glycerin for Diethylene Glycol; Availability.  Pages  24316-24317 [FR Doc. E7-08389 ]  [ TXT ] [ PDF ] Comments due July 2, 2007

Docket No. 2005N-0272, Proposed Rule .  Irradiation in the Production, Processing and Handling of Food.  Pages  16291-16306 [FR Doc. 07-01636]  [ TXT ] [ PDF ] Comments due July 5, 2007 Comments on the Collection Information due May 7, 2007

Docket No. 2007D-0118.  Draft Guidance for Industry on the Content and Format of the Dossage and Aministration Section of Labeling for Human Prescription Drug and Biological Products; Availability.  Pages  17561-17562 [FR Doc. E7-06508]  [ TXT ] [ PDF ] Comments due July 9, 2007

The Draft Guidance

Docket No. 2007D-0173.  Draft Guidance for Industry on Protecting the Rights, Safety, and Welfare of Study Subjects--Supervisory Responsibilities of Investigators; Availability.  Page  26639 [FR Doc. E7-09055 ]  [ TXT ] [ PDF ] Comments due July 9, 2007

The Draft Guidance

Docket No. 2007N-0155.  Defining and Implementing Quality in Clinical Investigations: From Design to Completion; Public Workshop; Request for Comments.  Pages  21270-21271 [FR Doc. E7-08137]  [ TXT ] [ PDF ] Workshop May 10, 2007 and May 11, 2007, Comments due July 10, 2007

Docket No. 2007N-0165.  Agency Information Collection Activities; Proposed Collection; Comment Request; Hazard Analysis and Critical Control Point Procedures for the Safe and Sanitary Processing and Importing of Juice.  Pages  27138-27140 [FR Doc. E7-09220 ]  [ TXT ] [ PDF ] Comments due July 13, 2007

Docket No. 2007N-0182.  Agency Information Collection Activities; Proposed Collection; Comment Request; Information Program on Clinical Trials for Serious or Life-Threatening Diseases: Maintaining a Data Bank.  Pages  27140-27142 [FR Doc. E7-09221 ]  [ TXT ] [ PDF ] Comments due July 13, 2007

Docket No. 1995C-0286.  Listing of Color Additives Subject to Certification; D&C Black No.3.  Pages  33664-33667 [FR Doc. E7-11801]  [ TXT ] [ PDF ] Objections/ Request for Hearning due July 19, 2007 Effective date July 20, 2007

Finding of No Significant Impact
Environmental Assessment

Docket No. 2007E-0066.  Determination of Regulatory Review Period for Purposes of Patent Extension; NOXAFIL.  Pages  28496-28497 [FR Doc. E7-09730 ]  [ TXT ] [ PDF ] Comments due July 20, 2007 Due diligence petitions due November 19, 2007

Docket No. 2004E-0398.  Determination of Regulatory Review Period for Purposes of Patent Extension; Iressa.  Pages  28497-28498 [FR Doc. E7-09733 ]  [ TXT ] [ PDF ] Comments due July 20, 2007 Due diligence petitions due November 19, 2007

Docket No. 2002E-0156.  Determination of Regulatory Review Period for Purposes of Patent Extension; GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM.  Pages  28498-28499 [FR Doc. E7-09720 ]  [ TXT ] [ PDF ] Comments due July 20, 2007 Due diligence petitions due November 19, 2007

Docket No. 2005E-02484.  Determination of Regulatory Review Period for Purposes of Patent Extension; FOSRENOL.  Pages  28700-28701 [FR Doc. E7-09787 ]  [ TXT ] [ PDF ] Comments due July 23, 2007 Due diligence petitions due November 19, 2007

Docket No. 2006E-0260.  Determination of Regulatory Review Period for Purposes of Patent Extension; ORENCIA.  Pages  28978-28979 [FR Doc. E7-09945 ]  [ TXT ] [ PDF ] Comments due July 23, 2007 Due diligence petitions due November 19, 2007

Docket No. 2006E-0501.  Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL.  Pages  28979-28908 [FR Doc. E7-09950 ]  [ TXT ] [ PDF ] Comments due July 23, 2007 Due diligence petitions due November 19, 2007

Docket No. 2007E-0002.  Determination of Regulatory Review Period for Purposes of Patent Extension; ELAPRASE.  Pages  28980-28981 [FR Doc. E7-09951 ]  [ TXT ] [ PDF ] Comments due July 23, 2007 Due diligence petitions due November 19, 2007

Docket No. 2004E-0319.  Determination of Regulatory Review Period for Purposes of Patent Extension; Bextra.  Pages  28984-28985 [FR Doc. E7-09957 ]  [ TXT ] [ PDF ] Comments due July 23, 2007 Due diligence petitions due November 19, 2007

Docket No. 2003E-0457.  Determination of Regulatory Review Period for Purposes of Patent Extension; SOMAVERT.  Pages  29172-29173 [FR Doc. E7-10052 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 23, 2007 Due diligence petitions due November 20, 2007

Docket No. 2002D-0005 (formerly 02D-0005).  International Cooperation on Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products (VICH); Revised Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Controlled List of Terms (VICH GL30); Request for Comments; Availability.  Pages  34261-34262 [FR Doc. E7-11996]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 23, 2007

The Draft Guidance

Docket No. 2007N-0204.  Joint Meeting of the Gastrointestinal Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee; Notice of Meeting.  Pages  29519-29520 [FR Doc. E7-10270 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Meeting on July 31, 2007 Comments due July 24, 2007

Docket No. 2007N-0200.  Agency Information Collection Activities; Proposed Collection; Comment Request; Health and Diet Survey.  Pages  29332-29333 [FR Doc. E7-10086]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 24, 2007

Docket No. 2007E-0009.  Determination of Regulatory Review Period for Purposes of Patent Extension; MYOZYME.  Pages  29333-29334 [FR Doc. E7-10087]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 24, 2007 Due diligence petitions due November 21, 2007

Docket No. 2006E-0516.  Determination of Regulatory Review Period for Purposes of Patent Extension; SPRYCEL--New Drug Applications 21-986 and 22-072.  Pages  29334-29335 [FR Doc. E7-10089 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 24, 2007 Due diligence petitions due November 21, 2007

Docket No. 2006E-0502.  Determination of Regulatory Review Period for Purposes of Patent Extension; PREZISTA.  Pages  29335-29336 [FR Doc. E7-10147 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 24, 2007 Due diligence petitions due November 21, 2007

Docket No. 2006E-0495.  Determination of Regulatory Review Period for Purposes of Patent Extension; KDR 401 and 403 PACEMAKERS.  Pages  29336-29337 [FR Doc. E7-10127 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 24, 2007 Due diligence petitions due November 21, 2007

Docket No. 2007N-0179.  Implementation of Risk Minimization Action Plans (RiskMAPs) to Support Quality Use of Pharmaceuticals: Opportunities and Challenges; Public Workshop.  Pages  28976-28977 [FR Doc. 07-02574]  [ TXT ] [ PDF ] Public workshop on June 25, 2007 and June 26, 2007 Comments due July 31, 2007

Docket No. 2007E-0046.  Determination of Regulatory Review Period for Purposes of Patent Extension; ZILMAX.  Pages  30594-30595 [FR Doc. E7-10602 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 31, 2007 Due diligence petitions due November 28, 2007

Docket No. 2007E-0011.  Determination of Regulatory Review Period for Purposes of Patent Extension; LANTUS.  Pages  30595-30596 [FR Doc. E7-10632 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 31, 2007 Due diligence petitions due November 28, 2007

Docket No. 2006E-0259.  Determination of Regulatory Review Period for Purposes of Patent Extension; X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM.  Pages  30596-30597 [FR Doc. E7-10618]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 31, 2007 Due diligence petitions due November 28, 2007

Docket No. 2006E-0282.  Determination of Regulatory Review Period for Purposes of Patent Extension; PHAKIC INTRAOCULAR LENSES.  Pages  30597-30598 [FR Doc. E7-10631 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 31, 2007 Due diligence petitions due November 28, 2007

Docket No. 2006E-0234.  Determination of Regulatory Review Period for Purposes of Patent Extension; GEM 21S GROWTH-FACTOR ENHANCED MATRIX.  Pages  30598-30599 [FR Doc. E7-10633 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 31, 2007 Due diligence petitions due November 28, 2007

August 2007

Docket No. 2007E-0010.  Determination of Regulatory Review Period for Purposes of Patent Extension; CHANTIX.  Pages  31588-31589 [FR Doc. E7-10915 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due August 6, 2007 Due Diligence Petitions due December 4, 2007

Docket No. 2007D-0213.  Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format--Receipt Date; Availability.  Pages  31079-31080 [FR Doc. E7-10780]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due August 6, 2007

The Draft Guidance

Docket No. 2006E-0332 and 2006E-0333.  Determination of Regulatory Review Period for purposes of Patent Extension; NAMENDA.  Pages  31075-31076 [FR Doc. E7-10730]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due August 6, 2007 Due diligence Petitions due December 3, 2007

Docket No. 2006N-0454, Proposed Rule.  Use of Ozone-Depleting Substances; Removal of Essential-Use Designations.  Pages  32030-32049 [FR Doc. 07-2883]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due August 10, 2007

Finding of No Significant Impact
Environmental Assessment

Docket No. 2007N-0219.  Agency Information Collection Activities; Proposed Collection; Comment Request; Animal Drug User Fees and Fee Waivers and Reductions.  Pages  32851-32852 [FR Doc. E7-11425]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due August 13, 2007

Docket No. 2007N-0218.  Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Pilot Program for Medical Products (Formally Medical Device Adverse Event Reporting Program) (Notice).  Pages  32670-32672 [FR Doc. E7-11400]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due August 13, 2007

Docket No. 2007D-0185.  Draft Guidance for Industry and Review Staff on Labeling for Human Presciption Drugs--Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information; Availability.  Pages  27576-27577 [FR Doc. E7-09347 ]  [ TXT ] [ PDF ] Comments due August 14, 2007

The Draft Guidance

Docket No. 2006E-0236.  Determination of Regulatory Review Period for Purposes of Patent Extension; TYGACIL.  Pages  7664-7665 [FR Doc. E7-2805]  [ TXT ] [ PDF ] Comments due April 16, 2007, Due Diligence Petitions due August 15, 2007

Docket No. 2007N-0227.  Agency Information Collection Activities; Proposed Collection; Comment Request; Medical Devices Third-Party Review Under the Federal Food and Drug Administration Modernization Act.  Pages  34257-34259 [FR Doc. E7-11981]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due August 20, 2007

Docket No. 2006E-0252.  Determination of Regulatory Review Period for Purposes of Patent Extension; LEVEMIR.  Pages  7999-8000 [FR Doc. E7-03001]  [ TXT ] [ PDF ] Comments due April 23, 2007, Due diligence petitions due August 21, 2007

Docket No. 2006E-0261.  Determination of Regulatory Review Period for Purposes of Patent Extension; EXJADE.  Pages  8180-8181 [FR Doc. E7-03041]  [ TXT ] [ PDF ] Comments due April 24, 2007, Due diligence petitions due August 22, 2007

Docket No. 2006E-0356.  Determination of Regulatory Review Period for Purposes of Patent Extension; BARACLUDE.  Pages  8181-8182 [FR Doc. E7-03042]  [ TXT ] [ PDF ] Comments due April 24, 2007, Due diligence petitions due August 22, 2007

Docket No. 2004E-0300, 2004E-0301, 2004E-0302, 2004E-0303, 2004E-0304, 2004E-0306, 2004E-0426, and 2006E-0206.  Determination of Regulatory Review Period for Purposes of Patent Extension; S8 OVER-THE-WIRE SYSTEM.  Pages  8182-8183 [FR Doc. E7-03127 ]  [ TXT ] [ PDF ] Comments due April 24, 2007, Due diligence petitions due August 22, 2007

Docket No. 2006E-0355.  Determination of Regulatory Review Period for Purposes of Patent Extension; AMITIZA.  Pages  8183-8184 [FR Doc. E7-03128 ]  [ TXT ] [ PDF ] Comments due April 24, 2007, Due diligence petitions due August 22, 2007

Docket No. 2007D-0168.  Draft Guidances for Industry Describing Product-Specific Bioequivalence Recommendations.  Pages  30386-30388 [FR Doc. E7–10491]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due September 28, 2007

Docket No. 2007D-0169.  Draft Guidance for Industry on Bioequivalence Recommendations for Specific Products.  Pages  30388-30390 [FR Doc. E7–10492]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due August 29, 2007

The Draft Guidance

September 2007

Docket No. 2007D-0212.  Draft Guidance for Industry on Malaria: Developing Drug and Nonvaccine Biological Products for Treatment and Prophylaxis; Availability.  Page  31590 [FR Doc. E7-11001 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due September 5, 2007

The Draft Guidance

Docket No. 2007N-0064.  Electronic Case Report Form Submission; Notice of Pilot Project.  Pages  11370-11371 [FR Doc. E7-04451 ]  [ TXT ] [ PDF ] Requests to participate due September 10, 2007

Docket No. 2007D-0223.  Draft Guidance for Industry on Use of the Computer Crossmatch; Availability.  Pages  34259-34260 [FR Doc. E7-11998]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due September 19, 2007

The Draft Guidance

Docket No. 2006E-0240.  Determination of Regulatory Review Period for Purposes of Patent Extension; REVLIMID.  Pages  14118-14119 [FR Doc. E7-05439 ]  [ TXT ] [ PDF ] Comments due May 25, 2007 Due diligence petitions due September 24, 2007

Docket No. 2006E-0034.  Determination of Regulatory Review Period for Purposes of Patent Extension; PREVICOX.  Pages  14119-14120 [FR Doc. E7-05443 ]  [ TXT ] [ PDF ] Comments due May 25, 2007 Due diligence petitions due September 24, 2007

Docket No. 2006E-0046.  Determination of Regulatory Review Period for Purposes of Patent Extension; ONYX LES.  Pages  14120-14121 [FR Doc. E7-05444 ]  [ TXT ] [ PDF ] Comments due May 25, 2007 Due diligence petitions due September 24, 2007

Docket No. 2006E-0478.  Determination of Regulatory Review Period for Purposes of Patent Extension; NOVOLOG.  Pages  14121-14122 [FR Doc. E7-05445 ]  [ TXT ] [ PDF ] Comments due May 25, 2007 Due diligence petitions due September 24, 2007

Docket No. 2005E-0259.  Determination of Regulatory Review Period for Purposes of Patent Extension; EMTRIVA.  Pages  14122-14123 [FR Doc. E7-05446 ]  [ TXT ] [ PDF ] Comments due May 25, 2007 Due diligence petitions due September 24, 2007

Docket No. 2003E-0252.  Determination of Regulatory Review Period for Purposes of Patent Extension; A180.  Pages  14280-14281 [FR Doc. E7-05504 ]  [ TXT ] [ PDF ] Comments due May 29, 2007 Due diligence petitions due September 24, 2007

Docket No. 2003E-0243 & 2003E-0244.  Determination of Regulatory Review Period for Purposes of Patent Extension; INFUSE BONE GRAFT/LT-CAGE LUMBAR TAPERED FUSION DEVICE.  Pages  14582-14583 [FR Doc. E7-05635]  [ TXT ] [ PDF ] Comments due May 29, 2007 Due diligence petitions due September 24, 2007

Docket No. 1997E-0013.  Determination of Regulatory Review Period for Purposes of Patent Extension; RETEVASE.  Pages  14818-14819 [FR Doc. E7-05736 ]  [ TXT ] [ PDF ] Comments due May 29, 2007 Due diligence petitions due September 25, 2007

Docket No. 2006E-0354. Determination of Regulatory Review Period for Purposes of Patent Extension; VAPRISOL.  Pages  14819-14820 [FR Doc. E7-05737 ]  [ TXT ] [ PDF ] Comments due May 29, 2007 Due diligence petitions due September 25, 2007

October 2007

Docket No. 2005E-0245.  Determination of Regulatory Review Period for Purposes of Patent Extension; KEPIVANCE.  Pages  15699-15700 [FR Doc. E7-06053 ]  [ TXT ] [ PDF ] Comments due June 1, 2007 Due Diligence Petitions due October 1, 2007

Docket No. 2003E-0256.  Determination of Regulatory Review Period for Purposes of Patent Extension; RANEXA.  Pages  15700-15701 [FR Doc. E7-06061]  [ TXT ] [ PDF ] Comments due June 1, 2007 Due Diligence Petitions due October 1, 2007

November 2007

Docket No. 2007E-0066.  Determination of Regulatory Review Period for Purposes of Patent Extension; NOXAFIL.  Pages  28496-28497 [FR Doc. E7-09730 ]  [ TXT ] [ PDF ] Comments due July 20, 2007 Due diligence petitions due November 19, 2007

Docket No. 2004E-0398.  Determination of Regulatory Review Period for Purposes of Patent Extension; Iressa.  Pages  28497-28498 [FR Doc. E7-09733 ]  [ TXT ] [ PDF ] Comments due July 20, 2007 Due diligence petitions due November 19, 2007

Docket No. 2002E-0156.  Determination of Regulatory Review Period for Purposes of Patent Extension; GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM.  Pages  28498-28499 [FR Doc. E7-09720 ]  [ TXT ] [ PDF ] Comments due July 20, 2007 Due diligence petitions due November 19, 2007

Docket No. 2005E-0248.  Determination of Regulatory Review Period for Purposes of Patent Extension; FOSRENOL.  Pages  28700-28701 [FR Doc. E7-09787 ]  [ TXT ] [ PDF ] Comments due July 23, 2007 Due diligence petitions due November 19, 2007

Docket No. 2006E-0260.  Determination of Regulatory Review Period for Purposes of Patent Extension; ORENCIA.  Pages  28978-28979 [FR Doc. E7-09945 ]  [ TXT ] [ PDF ] Comments due July 23, 2007 Due diligence petitions due November 19, 2007

Docket No. 2006E-0501.  Determination of Regulatory Review Period for Purposes of Patent Extension; GARDASIL.  Pages  28979-28908 [FR Doc. E7-09950 ]  [ TXT ] [ PDF ] Comments due July 23, 2007 Due diligence petitions due November 19, 2007

Docket No. 2007E-0002.  Determination of Regulatory Review Period for Purposes of Patent Extension; ELAPRASE.  Pages  28980-28981 [FR Doc. E7-09951 ]  [ TXT ] [ PDF ] Comments due July 23, 2007 Due diligence petitions due November 19, 2007

Docket No. 2004E-0319.  Determination of Regulatory Review Period for Purposes of Patent Extension; Bextra.  Pages  28984-28985 [FR Doc. E7-09957 ]  [ TXT ] [ PDF ] Comments due July 23, 2007 Due diligence petitions due November 19, 2007

Docket No. 2003E-0457.  Determination of Regulatory Review Period for Purposes of Patent Extension; SOMAVERT.  Pages  29172-29173 [FR Doc. E7-10052 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 23, 2007 Due diligence petitions due November 20, 2007

Docket No. 2007E-0009.  Determination of Regulatory Review Period for Purposes of Patent Extension; MYOZYME.  Pages  29333-29334 [FR Doc. E7-10087]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 24, 2007 Due diligence petitions due November 21, 2007

Docket No. 2006E-0516.  Determination of Regulatory Review Period for Purposes of Patent Extension; SPRYCEL--New Drug Applications 21-986 and 22-072.  Pages  29334-29335 [FR Doc. E7-10089 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 24, 2007 Due diligence petitions due November 21, 2007

Docket No. 2006E-0502.  Determination of Regulatory Review Period for Purposes of Patent Extension; PREZISTA.  Pages  29335-29336 [FR Doc. E7-10147 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 24, 2007 Due diligence petitions due November 21, 2007

Docket No. 2006E-0495.  Determination of Regulatory Review Period for Purposes of Patent Extension; KDR 401 and 403 PACEMAKERS.  Pages  29336-29337 [FR Doc. E7-10127 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 24, 2007 Due diligence petitions due November 21, 2007

Docket No. 2007E-0046.  Determination of Regulatory Review Period for Purposes of Patent Extension; ZILMAX.  Pages  30594-30595 [FR Doc. E7-10602 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 31, 2007 Due diligence petitions due November 28, 2007

Docket No. 2007E-0011.  Determination of Regulatory Review Period for Purposes of Patent Extension; LANTUS.  Pages  30595-30596 [FR Doc. E7-10632 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 31, 2007 Due diligence petitions due November 28, 2007

Docket No. 2006E-0259.  Determination of Regulatory Review Period for Purposes of Patent Extension; X-STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM.  Pages  30596-30597 [FR Doc. E7-10618]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 31, 2007 Due diligence petitions due November 28, 2007

Docket No. 2006E-0282.  Determination of Regulatory Review Period for Purposes of Patent Extension; PHAKIC INTRAOCULAR LENSES.  Pages  30597-30598 [FR Doc. E7-10631 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 31, 2007 Due diligence petitions due November 28, 2007

Docket No. 2006E-0234.  Determination of Regulatory Review Period for Purposes of Patent Extension; GEM 21S GROWTH-FACTOR ENHANCED MATRIX.  Pages  30598-30599 [FR Doc. E7-10633 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due July 31, 2007 Due diligence petitions due November 28, 2007

December 2007

Docket No. 2006E-0332 and 2006E-0333.  Determination of Regulatory Review Period for purposes of Patent Extension; NAMENDA.  Pages  31075-31076 [FR Doc. E7-10730]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due August 6, 2007 Due diligence Pettitons due December 3, 2007

Docket No. 2007E-0010.  Determination of Regulatory Review Period for Purposes of Patent Extension; CHANTIX.  Pages  31588-31589 [FR Doc. E7-10915 ]  [ TXT ] [ PDF ] [ PRE-PUB ] Comments due August 6, 2007 Due Diligence Petitions due December 4, 2007