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Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Notices6263Patent and Trademark Office requestedthat FDA determine the productsregulatory review period.FDA has determined that theapplicable regulatory review period forDIFFERIN Topical Gel is 2,447 days. Ofthis time, 1,401 days occurred duringthe testing phase of the regulatoryreview period, while 1,046 daysoccurred during the approval phase.These periods of time were derived fromthe following dates:1. The date an exemption undersection 505(i) of the Federal Food, Drug,and Cosmetic Act (21 U.S.C. 355(i))became effective: September 20, 1989.FDA has verified the applicant’s claimthat the date that the investigationalnew drug application became effectivewas on September 20, 1989.2. The date the application wasinitially submitted with respect to thehuman drug product under section505(b) of the Federal Food, Drug, andCosmetic Act: July 21, 1993. Theapplicant claims July 15, 1993, as thedate the new drug application (NDA) forDIFFERIN Topical Gel (NDA 20–380)was initially submitted. However, FDArecords indicate that NDA 20–380 wassubmitted on July 21, 1993.3. The date the application wasapproved: May 31, 1996. FDA hasverified the applicant’s claim that NDA20–380 was approved on May 31, 1996.This determination of the regulatoryreview period establishes the maximumpotential length of a patent extension.However, the U.S. Patent andTrademark Office applies severalstatutory limitations in its calculationsof the actual period for patent extension.In its application for patent extension,this applicant seeks 1,512 days of patentterm extension.Anyone with knowledge that any ofthe dates as published is incorrect may,on or before April 14, 1997, submit tothe Dockets Management Branch(address above) written comments andask for a redetermination. Furthermore,any interested person may petition FDA,on or before August 11, 1997, for adetermination regarding whether theapplicant for extension acted with duediligence during the regulatory reviewperiod. To meet its burden, the petitionmust contain sufficient facts to merit anFDA investigation. (See H. Rept. 857,part 1, 98th Cong., 2d sess., pp. 41–42,1984.) Petitions should be in the formatspecified in 21 CFR 10.30.Comments and petitions should besubmitted to the Dockets ManagementBranch (address above) in three copies(except that individuals may submitsingle copies) and identified with thedocket number found in brackets in theheading of this document. Commentsand petitions may be seen in theDockets Management Branch between 9a.m. and 4 p.m., Monday throughFriday.Dated: January 31, 1997.Stuart L. Nightingale,Associate Commissioner for Health Affairs.[FR Doc. 97–3314 Filed 2–10–97; 8:45 am]BILLING CODE 4160–01–F[Docket No. 96E–0387]Determination of Regulatory ReviewPeriod for Purposes of PatentExtension; DECTOMAXAGENCY: Food and Drug Administration,HHS.ACTION: Notice.SUMMARY: The Food and DrugAdministration (FDA) has determinedthe regulatory review period forDECTOMAX and is publishing thisnotice of that determination as requiredby law. FDA has made thedetermination because of thesubmission of an application to theCommissioner of Patents andTrademarks, Department of Commerce,for the extension of a patent whichclaims that animal drug product.ADDRESSES: Written comments andpetitions should be directed to theDockets Management Branch (HFA–305), Food and Drug Administration,12420 Parklawn Dr., rm. 1–23,Rockville, MD 20857.FOR FURTHER INFORMATION CONTACT:Brian J. Malkin, Office of Health Affairs(HFY–20), Food and DrugAdministration, 5600 Fishers Lane,Rockville, MD 20857, 301–443–1382.SUPPLEMENTARY INFORMATION: The DrugPrice Competition and Patent TermRestoration Act of 1984 (Pub. L. 98–417)and the Generic Animal Drug and PatentTerm Restoration Act (Pub. L. 100–670)generally provide that a patent may beextended for a period of up to 5 yearsso long as the patented item (humandrug product, animal drug product,medical device, food additive, or coloradditive) was subject to regulatoryreview by FDA before the item wasmarketed. Under these acts, a product’sregulatory review period forms the basisfor determining the amount of extensionan applicant may receive.A regulatory review period consists oftwo periods of time: A testing phase andan approval phase. For animal drugproducts, the testing phase begins onthe earlier date when either a majorenvironmental effects test was initiatedfor the drug or when an exemptionunder section 512(j) of the Federal Food,Drug, and Cosmetic Act (21 U.S.C.360b(j)) became effective and runs untilthe approval phase begins. The approvalphase starts with the initial submissionof an application to market the animaldrug product and continues until FDAgrants permission to market the drugproduct. Although only a portion of aregulatory review period may counttoward the actual amount of extensionthat the Commissioner of Patents andTrademarks may award (for example,half the testing phase must besubtracted as well as any time that mayhave occurred before the patent wasissued), FDA’s determination of thelength of a regulatory review period foran animal drug product will include allof the testing phase and approval phaseas specified in 35 U.S.C. 156(g)(4)(B).FDA recently approved for marketingthe animal drug product DECTOMAX(doramectin). DECTOMAX is indicatedfor cattle treatment and control ofgastrointestinal roundworms,lungworms, eyeworms, grubs, lice, andmange mites, and protection againstinfection or reinfection with Ostertaglaostertagia for up to 21 days. Subsequentto this approval, the Patent andTrademark Office received a patent termrestoration application for DECTOMAX(U.S. Patent No. 5,089,480) from Pfizer,Inc., and the Patent and TrademarkOffice requested FDA’s assistance indetermining this patent’s eligibility forpatent term restoration. In a letter datedOctober 25, 1996, FDA advised thePatent and Trademark Office that thisanimal drug product had undergone aregulatory review period and that theapproval of DECTOMAX representedthe first commercial marketing of theproduct. Shortly thereafter, the Patentand Trademark Office requested thatFDA determine the product’s regulatoryreview period.FDA has determined that theapplicable regulatory review period forDECTOMAX is 2,836 days. Of this time,2,695 days occurred during the testingphase of the regulatory review period,while 141 days occurred during theapproval phase. These periods of timewere derived from the following dates:1. The date an exemption undersection 512(j) of the Federal Food, Drug,and Cosmetic Act became effective:October 26, 1988. The applicant claimsDecember 7, 1988, as the date theinvestigational new animal drugapplication (INAD) became effective.However, FDA records indicate that thedate of FDA’s official acknowledgmentletter assigning a number to the INADwas October 26, 1988, which isconsidered to be the effective date forthe INAD.
6264 Federal Register / Vol. 62, No. 28 / Tuesday, February 11, 1997 / Notices2. The date the application wasinitially submitted with respect to theanimal drug product under section512(b) of the Federal Food, Drug, andCosmetic Act: March 12, 1996. Theapplicant claims March 7, 1996, as thedate the new animal drug application(NADA) for DECTOMAX (NADA 141–061) was initially submitted. However,FDA records indicate that the date ofFDA’s official acknowledgment letterassigning a number to the NADA wasMarch 12, 1996, which is considered tobe the NADA initially submitted date.3. The date the application wasapproved: July 30, 1996. FDA hasverified the applicant’s claim thatNADA 141–061 was approved on July30, 1996.This determination of the regulatoryreview period establishes the maximumpotential length of a patent extension.However, the U.S. Patent andTrademark Office applies severalstatutory limitations in its calculationsof the actual period for patent extension.In its application for patent extension,this applicant seeks 527 days of patentterm extension.Anyone with knowledge that any ofthe dates as published is incorrect may,on or before April 14, 1997, submit tothe Dockets Management Branch(address above) written comments andask for a redetermination. Furthermore,any interested person may petition FDA,on or before August 11, 1997, for adetermination regarding whether theapplicant for extension acted with duediligence during the regulatory reviewperiod. To meet its burden, the petitionmust contain sufficient facts to merit anFDA investigation. (See H. Rept. 857,part 1, 98th Cong., 2d sess., pp. 41–42,1984.) Petitions should be in the formatspecified in 21 CFR 10.30.Comments and petitions should besubmitted to the Dockets ManagementBranch (address above) in three copies(except that individuals may submitsingle copies) and identified with thedocket number found in brackets in theheading of this document. Commentsand petitions may be seen in theDockets Management Branch between 9a.m. and 4 p.m., Monday throughFriday.Dated:January 31, 1997.Stuart L. Nightingale,Associate Commissioner for Health Affairs.[FR Doc. 97–3315 Filed 2–10–97; 8:45 am]BILLING CODE 4160–01–FDEPARTMENT OF THE INTERIOROffice of the Secretary; Glen CanyonDam Adaptive Management WorkGroup; Notice of EstablishmentThis notice is published inaccordance with Section 9(a)(2) of theFederal Advisory Committee Act (Pub.L. 92–463). Following consultation withthe General Services Administration,notice is hereby given that the Secretaryof the Interior (Secretary) is establishingthe Glen Canyon Dam AdaptiveManagement Work Group. The purposeof the Adaptive Management WorkGroup shall be to advise and providerecommendations to the Secretary withrespect to his responsibility to complywith the Grand Canyon Protection Actof October 30, 1992, embodied in PublicLaw 102–575.Further information regarding theadvisory council may be obtained fromthe Bureau of Reclamation, Departmentof the Interior, 1849 C Street, NW,Washington, DC 20240.The certification of establishment ispublished below.CertificationI hereby certify that establishment ofthe Glen Canyon Dam AdaptiveManagement Work Group is in thepublic interest in connection with thepurpose of duties imposed on theDepartment of the Interior by 30 U.S.C.1–8.Dated: January 15, 1997.Bruce Babbitt,Secretary of the Interior.[FR Doc. 97–3318 Filed 2–10–97; 8:45 am]BILLING CODE 4310–94–MFish and Wildlife ServiceEndangered and Threatened SpeciesPermit ApplicationsACTION: Notice of receipt of applications.SUMMARY: The following applicants haveapplied for a permit to conduct certainactivities with endangered species. Thisnotice is provided pursuant to section10(c) of the Endangered Species Act of1973, as amended (16 U.S.C. 1531, etseq.).Permit No. 823110Applicant: Charles W. Cartwright, Jr.,Albuquerque, New MexicoThe applicant requests authorizationfor research and recovery purposes tosurvey for the cactus ferruginous pygmyowl (Glaucidium brasilianum cactorum)and the Yuma clapper rail (Ralluslongirostris yumanensis).Permit No. 813889Applicant: Larry Benallie, Sr., Window Rock,ArizonaThe applicant requests authorizationfor research and recovery purposes tosurvey parts of the Navajo Nation for thepossible occurrence of the Kanabambersnail (Oxyloma haydeni ssp.kanabensis).Permit No. 823253Applicant: John Lloyd-Reilley, Kingsville,TexasThe applicant requests authorizationto perfom an intensive study of slenderrush-pea (Hoffmannseggia tenella) forpossible reintroduction to wildlandsites. Applicant was previously grantedpermission to collect the seeds ofslender rushpea and propagate plantsfor research and recovery purposes.Permit No. 823293Applicant: Joseph B. Gebler, Tucson, ArizonaApplicant requests authorization forresearch and recovery purposes tocollect up to 10 of the followingendangered fish species from variouslocales within Arizona for ecologicaland contaminant assessment. Exceptwhen vouchered, endangered andthreatened species will be releasedunharmed immediately.Chub, bonytail (Gila elegans,)Pupfish, desert (Cyprinodonmacularius)Minnow, loach (Rhinichthys (=Tiaroga)cobitis)Squawfish, Colorado (Ptychocheiluslucius)Spikedace (Meda fulgida)Sucker, razorback (Xyrauchen texanus)Topminnow, Gila (Poeciliopsisoccidentalis)Trout, Apache (Oncorhynchus apache)Trout, Gila (Oncorhynchus gilae)Woundfin (Plagopterus argentissimus)Permit No. 823354Applicant: Dr. Ross Dawkins, San Angelo,TexasApplicant requests authorization tosurvey, map territory distribution,capture (using mist nets) band, measure,and immediately release unharmed nomore than five black-capped vireos(Vireo atricapillus). Work would beconducted in Terrell, Brushy Canyon,and Brewster Counties, Texas.Permit No. 823431Applicant: Nancy London, Wickenburg,ArizonaThe applicant requests authorizationto observe, survey, and monitor forsouthwestern willow flycatchers(Empidonax traillii extimus) todetermine habitat preferences of thespecies.
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