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`56157
`Federal Register/Vol. 71, No. 186/Tuesday, September 26, 2006/Notices
`
`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`
`Food and Drug Administration
`[Docket Nos. 2006E—0023 and 2006E—0345]
`
`Determination of Regulatory Review
`Period for Purposes of Patent
`Extension; MYCAMINE—New Drug
`Application 21—506
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Notice.
`
`SUMMARY: The Food and Drug
`Administration (FDA) has determined
`the regulatory review period for
`MYCAMINE and is publishing this
`notice of that determination as required
`by law. FDA has made the
`determination because of the
`submission of applications to the
`Director of Patents and Trademarks,
`Department of Commerce, for the
`extension of patents which claim that
`human drug product.
`ADDRESSES: Submit written comments
`and petitions to the Division of Dockets
`Management (HFA—BOS], Food and Drug
`Administration, 5630 Fishers Lane, rm.
`1061, Rockville, MD 20852. Submit
`electronic comments to http://
`WWWfda,goV/dookets/ecomments.
`FOR FURTHER INFORMATION CONTACT:
`Beverly Friedman, Office of Regulatory
`Policy (HFD—7], Food and Drug
`Administration, 5600 Fishers Lane,
`ROCkVillc, MD 20857, 301—594—2041.
`SUPPLEMENTARY INFORMATION: The Drug
`Price Competition and Patent Term
`Restoration Act of 1984 (Public Law 98—
`417] and the Generic Animal Drug and
`Patent Term Restoration Act (Public
`Law 100—670) generally provide that a
`patent may be extended for a period of
`up to 5 years so long as the patented
`item (human drug product, animal drug
`product, medical device, food additive,
`or color additive) was subject to
`regulatory review by FDA before the
`item was marketed. Under these acts, a
`product’s regulatory review period
`forms the basis for determining the
`amount of extension an applicant may
`receive.
`A regulatory review period consists of
`two periods of time: A testing phase and
`an approval phase. For human drug
`products, the testing phase begins when
`the exemption to permit the clinical
`investigations of the human drug
`product becomes effective and runs
`until the approval phase begins. The
`approval phase starts with the initial
`submission of an application to market
`the human drug product and continues
`until FDA grants permission to market
`
`the drug product. Although only a
`portion of a regulatory review period
`may count toward the actual amount of
`extension that the Director of Patents
`and Trademarks may award (for
`example, half the testing phase must be
`subtracted, as well as any time that may
`have occurred before the patent was
`issued], FDA's determination of the
`length of a regulatory review period for
`a human drug product will include all
`of the testing phase and approval phase
`as specified in 35 U.S.C, 156(g][1l(B].
`FDA recently approved for marketing
`the human drug product MYCAMINE
`(micafungin sodium). MYCAMINE is
`indicated for treatment of patients with
`esophageal candidiasis and prophylaxis
`of Candida infections in patients
`undergoing hematopoietic stem cell
`transplantation. Subsequent to this
`approval, the Patent and Trademark
`Office received patent term restoration
`applications for MYCAMINE (U.S.
`Patent Nos. 6,107,458 and 6,265,536)
`from Astellas Pharma, Inc., and the
`Patent and Trademark Office requested
`FDA’S assistance in determining these
`patents’ eligibility for patent term
`restoration. In a letter dated February
`24, 2006, FDA advised the Patent and
`Trademark Office that this human drug
`product had undergone a regulatory
`review period and that the approval of
`MYCAMINE represented the first
`permitted commercial marketing or use
`of the product. Thereafter, the Patent
`and Trademark Office requested that
`FDA determine the product’s regulatory
`review eriod.
`FDA as determined that the
`applicable regulatory review period for
`MYCAMINE is 2,546 days. Of this time,
`1,493 days occurred during the testing
`phase of the regulatory review period,
`while 1,053 days occurred during the
`approval phase. These periods of time
`were derived from the following dates:
`1. The date an exemption under
`section 505(i} of the Federal Food, Drug,
`and Cosmetic Act [the act) {21 U.S,C,
`355(i)) became effective: March 29,
`1998. The applicant claims February 26,
`1998, as the date the investigational new
`drug application (IND) became effective.
`However, FDA records indicate that the
`IND effective date was March 29, 1998,
`which was 30 days after FDA receipt of
`the original IND.
`2, The date the application was
`initially submitted with respect to the
`human drug product under section
`505(b) of the act: April 29, 2002. FDA
`has verified the applicant’s claim that
`the new drug application (NDA) for
`MYCAMINE (NDA 21—506) was initially
`submitted on April 29, 2002.
`3. The date the application was
`approved: March 16, 2005. FDA has
`
`verified the applicant’s claim that NDA
`21—506 was approved on March 16,
`2005.
`This determination of the regulatory
`review period establishes the maximum
`potential length of a patent extension.
`However, the U.S. Patent and
`Trademark Office applies several
`statutory limitations in its calculations
`of the actual period for patent extension.
`In its applications for patent extension,
`this applicant seeks 1,192 days of patent
`term extension.
`Anyone with knowledge that any of
`the dates as published are incorrect may
`submit to the Division of Dockets
`Management (see ADDRESSES) written or
`electronic comments and ask for a
`redetermination by November 27, 2006.
`Furthermore, any interested person may
`petition FDA for a determination
`regarding whether the applicant for
`extension acted with due diligence
`during the regulatory review period by
`March 26, 2007. To meet its burden, the
`petition must contain sufficient facts to
`merit an FDA investigation. (See H.
`Rept. 857, part 1, 98th Cong, 2d sess.,
`pp. 41—42, 1984.] Petitions should be in
`the format specified in 21 CFR 10.30.
`Comments and petitions should be
`submitted to the Division of Dockets
`Management. Three copies of any
`mailed information are to be submitted,
`except that individuals may submit one
`copy. Comments are to be identified
`with the docket numbers found in
`brackets in the heading of this
`document. Comments and petitions may
`be seen in the Division of Dockets
`Management between 9 am. and 4 p.m.,
`Monday through Friday.
`Dated: September 9, 2006.
`Jane A. Axelrad,
`Associate Directorfor Policy, Centerfor Drug
`Evaluation and Research.
`[FR Doc. E6—15767 Filed 9—25—06; 8:45 am]
`BILLING CODE 4160-01—3
`
`
`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`
`Food and Drug Administration
`[Docket Nos. 2006M—0161, 2006M—0264,
`2006M—0148, 2006M-0200, 2006M-0162,
`2006M—0199, 2006M~0193, 2006M—0235]
`
`Medical‘Devices; Availability of Safety
`and Effectiveness Summaries for
`Premarket Approval Applications
`AGENCY: Food and Drug Administration,
`HHS.
`ACTION: Notice.
`
`SUMMARY: The Food and Drug
`Administration (FDA) is publishing a
`list of premarket approval applications
`
`Exhibit 1 075
`
`Prollenium v. Allergan
`IPR2019-01505 et a1.
`
`Exhibit 1075
`Prollenium v. Allergan
`IPR2019-01505 et al.
`
`

`

`56158
`Federal Register/Vol. 71, No. 186/Tuesday, September 26, 2006/NoticesW
`
`(PMAs) that have been approved. This
`list is intended to inform the public of
`the availability of safety and
`effectiveness summaries of approved
`PMAs through the Internet and the
`agency’s Division of Dockets
`Management.
`
`ADDRESSES: Submit written requests for
`copies of summaries of safety and
`effectiveness to the Division of Dockets
`Management [HFA—SOS), Food and Drug
`Administration, 5630 Fishers Lane, rm.
`1061, Rockville, MD 20852. Please cite
`the appropriate docket number as listed
`in Table 1 of this document when
`submitting a written request. See the
`SUPPLEMENTARY INFORMATION section for
`electronic access to the summaries of
`safety and effectiveness.
`FOR FURTHER INFORMATION CONTACT:
`
`Thinh Nguyen, Center for Devices and
`Radiological Health [HFZ—402), Food
`and Drug Administration, 9200
`Corporate Blvd, Rockville, MD 20850,
`301—594—2188, ext. 152.
`
`SUPPLEMENTARY INFORMATION:
`
`1. Background
`In the Federal Register of January 30,
`1998 (63 FR 4571], FDA published a
`final rule that revised 21 CFR 814.44Id)
`and 814.45(d) to discontinue individual
`publication of PMA approvals and
`denials in the Federal Register. Instead,
`the agenCy now posts this information
`on the Internet on FDA’s home page at
`http://www.fda.gov. FDA believes that
`this procedure expedites public
`notification of these actions because
`announcements can be placed on the
`Internet more quickly than they can be
`published in the Federal Register, and
`FDA believes that the Internet is
`accessible to more people than the
`Federal Register
`In accordance with section 515(d)(4)
`and (e)(2 ] of the Federal Food, Drug, and
`Cosmetic Act [the act] [21 U.S.C.
`360e(d][4) and (e)(2)), notification of an
`order approving, denying, or
`withdrawing approval of a PMA will
`continue to include a notice of
`opportunity to request review of the
`order under section 515(g) of the act.
`The 30-day period for requesting
`
`reconsideration of an FDA action under
`§10.33(b) [21 CFR 10.33(b]) for notices
`announcing approval of a PMA begins
`on the day the notice is placed on the
`Internet. Section 10.33(b) provides that
`FDA may, for good cause, extend this
`30-day period. Reconsideration of a
`denial or withdrawal of approval of a
`PMA may be sought only by the
`applicant; in these cases, the 30-day
`period Will begin when the applicant is
`notified by FDA in writing of its
`decision.
`
`The regulations provide that FDA
`publish a quarterly list of available
`safety and effectiveness summaries of
`PMA approvals and denials that were
`announced during that quarter. The
`following is a list of approved PMAs for
`which summaries of safety and
`effectiveness were placed on the
`Internet from April 1, 2006, through
`June 30, 2.006. There were no denial
`actions during this period. The list
`provides the manufacturer’s name, the
`product’s generic name or the trade
`name, and the approval date.
`
`TABLE l.—LIST OF SAFETY AND EFFECTIVENESS SUMMARIES FOR APPROVED PMAS MADE AVAILABLE FROM APRIL 1,
`2006, THROUGH JUNE 30, 2006
`
`Applicant
`
`Trade Name
`
`QLT, Inc.
`P050026/2006M—0162
`
`
`QUALTEL ACTIVIS LASER & ZSL30 ACT. ZSL120 ACT,
`
`and HSBMBQ ACT SLIT LAMP ADAPTERS
`
`PMA No /Docket No
`
`
`Approval Date
`
`PO50021/2006M 0161
`CERALAS | LASER & CERALINK SLIT LAMP ADAPTER December 20, 2005
`QLT, Inc.
`
`
`March 3, 2006
`
`P040052/2006M-0264 MonoGen, Inc
`MONOPREP PAP TEST ()MPPT
`
`
`
` March 16, 2006LUMA CERVICAL IMAGING SYSTEM
` Medispectra, Inc.
`PO40028/2006M—014B
`
`
`March 24, 2006
`Dexcom, Inc.
`P050012/2006M—0200
`
`DEXCOM (STS) CONTINUOUS GLUCOSE MONI-
`
`TORING SYSTEM
`
`
` April 4, 2006
`
`
`April 19, 2006
`
`
`
`May 9, 2006
`
`June 2, 2006
`
`
`
`
`
`P030008(S4)/2006M—0199
`
`
`
`WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER
`SurgiVision Refractive Con-
`
`suItants SYSTEM
`
`P050047/2006M—0235
`
`Inamed Corp.
`
`BIRMINGHAM HIP RESURFACING (BHR) SYSTEM
`
`
`SOHV GEL IMPLANTS
`
`
`P040083/2006M—0193
`Smith & Nephew
`
`Orthopaedics
`JUVEDERM 24HV, JUVEDERM 30, and JUVEDERM
`
`II. Electronic Access
`
`Persons with access to the Internet
`
`may obtain the documents at http://
`WWW.fda.gov/cdrh/pmapage.htm1.
`Dated: September 15, 2006.
`Linda S. Kahan,
`
`DeputyDirector, Centerfor Devices and
`Radiological Health.
`[FR Doc. Eli—15755 Filed 9—25—06; 8:45 am]
`BILLING CODE 4180—01—5
`
`DEPARTMENT OF HEALTH AND
`HUMAN SERVICES
`
`ACTION: Notice of public meeting;
`request for comments.
`
`Food and Drug Administration
`
`[Docket No. 2006N—0107]
`
`Food and Drug Administration-
`Regulated Products Containing
`Nanotechnology Materials; Public
`Meeting
`
`AGENCY: Food and Drug Administration,
`HHS.
`
`SUMMARY: This is an update to previous
`notice that the Food and Drug ’
`Administration [FDA) will hold a public
`meeting October 10, 2006, on
`nanotechnology as it relates to FDA~
`regulated products. The primary
`purpose of this update is to notify the
`public that preregistration to attend or
`speak at the public meeting will close
`on September 29, 2006. The purpose of
`the meeting is to help FDA further its
`understanding of developments in
`
`