Determination of Regulatory Review Period for Purposes of Patent Extension; SOMATULINE DEPOT, 67874-67875 [E8-27179]

Download as PDF 67874 Federal Register / Vol. 73, No. 222 / Monday, November 17, 2008 / Notices Compliance With Section 301 of the Medical Device User Fee and Modernization Act of 2002, as Amended: Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices (formerly ‘‘Reprocessed SingleUse Device Labeling’’) (Federal Food, Drug, and Cosmetic Act, Section 502(u)) (OMB Control Number 0910–0577)— Extension Section 502 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 352), among other things, establishes requirements that the label or labeling of a medical device must meet so that it is not misbranded and subject to regulatory action. Section 301 of the Medical Device User Fee and Modernization Act of 2002 (Public Law 107–250) amended section 502 of the act to add section 502(u) to require devices (both new and reprocessed) to bear prominently and conspicuously the name of the manufacturer, a generally recognized abbreviation of such name, or a unique and generally recognized symbol identifying the manufacturer. Thus, the name for this information collection activity has been changed to more accurately describe the information collection content. Section 2(c) of The Medical Device User Fee Stabilization Act of 2005 (Public Law 109–43) amends section 502(u) of the act by limiting the provision to reprocessed single-use devices (SUDs) and the manufacturers who reprocess them. Under the amended provision, if the original SUD or an attachment to it prominently and conspicuously bears the name of the manufacturer, then the reprocessor of the SUD is required to identify itself by name, abbreviation, or symbol, in a prominent and conspicuous manner on the device or attachment to the device. If the original SUD does not prominently and conspicuously bear the name of the manufacturer, the manufacturer who reprocesses the SUD for reuse may identify itself using a detachable label that is intended to be affixed to the patient record. The requirements of section 502(u) of the act impose a minimal burden on industry. This section of the act only requires the manufacturer, packer, or distributor of a device to include their name and address on the labeling of a device. This information is readily available to the establishment and easily supplied. From its registration and premarket submission database, FDA estimates that there are 10 establishments that distribute approximately 1,000 reprocessed SUDs. Each response is anticipated to take 0.1 hours resulting in a total burden to industry of 100 hours. FDA estimates the burden of this collection of information as follows: TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1 No. of Respondents Section of the Act 502(u) No. of Responses per Respondent 10 1 There Total Annual Responses 100 1,000 Dated: November 5, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–27178 Filed 11–14–08; 8:45 am] BILLING CODE 4160–01–S SOMATULINE DEPOT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of Patents and Trademarks, Department of Commerce, for the extension of a patent which claims that human drug product. ADDRESSES: Submit written comments and petitions 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.regulations.gov. FOR FURTHER INFORMATION CONTACT: DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–E–0111] Determination of Regulatory Review Period for Purposes of Patent Extension; SOMATULINE DEPOT jlentini on PROD1PC65 with NOTICES Food and Drug Administration, HHS. ACTION: Total Hours .1 100 are no capital costs or operating and maintenance costs associated with this collection of information. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. AGENCY: Hours Per Response Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for VerDate Aug<31>2005 18:18 Nov 14, 2008 Jkt 217001 Beverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993– 0002, 301–796–3602. 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 PO 00000 Frm 00040 Fmt 4703 Sfmt 4703 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 drug 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)(1)(B). FDA recently approved for marketing the human drug product SOMATULINE DEPOT (lanreotide). SOMATULINE DEPOT is indicated for the long-term treatment of acromegalic patients who E:\FR\FM\17NON1.SGM 17NON1 jlentini on PROD1PC65 with NOTICES Federal Register / Vol. 73, No. 222 / Monday, November 17, 2008 / Notices have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for SOMATULINE DEPOT (U.S. Patent No. 5,595,760) from Society De Conseils De Recherches Et D’Applications Scientifiques, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated April 22, 2008, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of SOMATULINE DEPOT represented the first permitted commercial marketing or use of the product. Shortly thereafter, the Patent and Trademark Office requested that FDA determine the product’s regulatory review period. FDA has determined that the applicable regulatory review period for SOMATULINE DEPOT is 3,629 days. Of this time, 3,324 days occurred during the testing phase of the regulatory review period, while 305 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) became effective: September 24, 1997. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on September 24, 1997. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: October 30, 2006. FDA has verified the applicant’s claim that the new drug application (NDA) for SOMATULINE DEPOT (NDA 22–074) was initially submitted on October 30, 2006. 3. The date the application was approved: August 30, 2007. FDA has verified the applicant’s claim that NDA 22–074 was approved on August 30, 2007. 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 application for patent extension, this applicant seeks 5 years 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 VerDate Aug<31>2005 18:18 Nov 14, 2008 Jkt 217001 67875 redetermination by January 16, 2009. 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 May 18, 2009. 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 number found in brackets in the heading of this document. Comments and petitions may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. Please note that on January 15, 2008, the FDA Division of Dockets Management Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic comments or submissions will be accepted by FDA only through FDMS at http://www.regulations.gov. SUPPLEMENTARY INFORMATION: Dated: October 20, 2008. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E8–27179 Filed 11–14–08; 8:45 am] BILLING CODE 9111–23–P BILLING CODE 4160–01–S Federal Emergency Management Agency DEPARTMENT OF HOMELAND SECURITY [FEMA–1804–DR] Federal Emergency Management Agency [FEMA–1795–DR] Indiana; Amendment No. 7 to Notice of a Major Disaster Declaration Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: SUMMARY: This notice amends the notice of a major disaster declaration for the State of Indiana (FEMA–1795–DR), dated September 23, 2008, and related determinations. DATES: Effective Date: November 7, 2008. FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886. PO 00000 Frm 00041 Fmt 4703 Sfmt 4703 The notice of a major disaster declaration for the State of Indiana is hereby amended to include the following areas among those areas determined to have been adversely affected by the event declared a major disaster by the President in his declaration of September 23, 2008. LaPorte County for Public Assistance (already designated for Individual Assistance). Daviess County for Public Assistance. (The following Catalog of Federal Domestic Assistance Numbers (CFDA) are to be used for reporting and drawing funds: 97.030, Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis Counseling; 97.033, Disaster Legal Services; 97.034, Disaster Unemployment Assistance (DUA); 97.046, Fire Management Assistance Grant; 97.048, Disaster Housing Assistance to Individuals and Households In Presidentially Declared Disaster Areas; 97.049, Presidentially Declared Disaster Assistance— Disaster Housing Operations for Individuals and Households; 97.050 Presidentially Declared Disaster Assistance to Individuals and Households—Other Needs; 97.036, Disaster Grants—Public Assistance (Presidentially Declared Disasters); 97.039, Hazard Mitigation Grant.) R. David Paulison, Administrator, Federal Emergency Management Agency. [FR Doc. E8–27164 Filed 11–14–08; 8:45 am] DEPARTMENT OF HOMELAND SECURITY Arkansas; Major Disaster and Related Determinations Federal Emergency Management Agency, DHS. ACTION: Notice. AGENCY: SUMMARY: This is a notice of the Presidential declaration of a major disaster for the State of Arkansas (FEMA–1804–DR), dated October 22, 2008, and related determinations. DATES: Effective Date: October 22, 2008. FOR FURTHER INFORMATION CONTACT: Peggy Miller, Disaster Assistance Directorate, Federal Emergency Management Agency, 500 C Street, SW., Washington, DC 20472, (202) 646–3886. SUPPLEMENTARY INFORMATION: Notice is hereby given that, in a letter dated October 22, 2008, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 E:\FR\FM\17NON1.SGM 17NON1

Agencies

[Federal Register Volume 73, Number 222 (Monday, November 17, 2008)]
[Notices]
[Pages 67874-67875]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-27179]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0111]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; SOMATULINE DEPOT

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY:  The Food and Drug Administration (FDA) has determined the 
regulatory review period for SOMATULINE DEPOT and is publishing this 
notice of that determination as required by law. FDA has made the 
determination because of the submission of an application to the 
Director of Patents and Trademarks, Department of Commerce, for the 
extension of a patent which claims that human drug product.

ADDRESSES:  Submit written comments and petitions 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.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

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 drug 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)(1)(B).
    FDA recently approved for marketing the human drug product 
SOMATULINE DEPOT (lanreotide). SOMATULINE DEPOT is indicated for the 
long-term treatment of acromegalic patients who

[[Page 67875]]

have had an inadequate response to or cannot be treated with surgery 
and/or radiotherapy. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
SOMATULINE DEPOT (U.S. Patent No. 5,595,760) from Society De Conseils 
De Recherches Et D'Applications Scientifiques, and the Patent and 
Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
April 22, 2008, FDA advised the Patent and Trademark Office that this 
human drug product had undergone a regulatory review period and that 
the approval of SOMATULINE DEPOT represented the first permitted 
commercial marketing or use of the product. Shortly thereafter, the 
Patent and Trademark Office requested that FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
SOMATULINE DEPOT is 3,629 days. Of this time, 3,324 days occurred 
during the testing phase of the regulatory review period, while 305 
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) became effective: 
September 24, 1997. FDA has verified the applicant's claim that the 
date the investigational new drug application became effective was on 
September 24, 1997.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: October 30, 
2006. FDA has verified the applicant's claim that the new drug 
application (NDA) for SOMATULINE DEPOT (NDA 22-074) was initially 
submitted on October 30, 2006.
    3. The date the application was approved: August 30, 2007. FDA has 
verified the applicant's claim that NDA 22-074 was approved on August 
30, 2007.
    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 
application for patent extension, this applicant seeks 5 years 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 January 16, 2009. 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 May 18, 
2009. 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 number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: October 20, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-27179 Filed 11-14-08; 8:45 am]
BILLING CODE 4160-01-S