Determination of Regulatory Review Period for Purposes of Patent Extension; INTELENCE, 24014-24015 [E9-12050]

Download as PDF erowe on PROD1PC63 with NOTICES 24014 Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices Paperwork Reduction Act of 1995, the Centers for Medicare & Medicaid Services (CMS), Department of Health and Human Services, is publishing the following summary of proposed collections for public comment. Interested persons are invited to send comments regarding this burden estimate or any other aspect of this collection of information, including any of the following subjects: (1) The necessity and utility of the proposed information collection for the proper performance of the Agency’s function; (2) the accuracy of the estimated burden; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. 1. Type of Information Collection Request: Revision of a currently approved collection; Title of Information Collection: Medicare Part D Reporting Requirements and Supporting Regulations under 42 CFR 423.505; Form Number: CMS–10185 (OMB#: 0938–0992); Use: Title I, Part 423, § 423.514 describes CMS’ regulatory authority to establish requirements for Part D sponsors. It is noted that each Part D plan sponsor must have an effective procedure to develop, compile, evaluate, and report to CMS, its enrollees, and the general public, at the times and in the manner that CMS requires, statistics in the following areas: (1) The cost of its operations; (2) The availability of utilization of its services; (3) The availability, accessibility; and acceptability of its services; (4) Information demonstrating that the Part D plan sponsor has a fiscally sound operation; and (5) other matters that CMS may require. Subsection 423.505 of the Medicare Prescription Drug Modernization and Modernization Act establishes as a contract provision that Part D Sponsors must comply with the reporting requirements for submitting drug claims and related information to CMS. Data collected via Medicare Part D Reporting Requirements will be an integral resource for oversight, monitoring, compliance and auditing activities necessary to ensure quality provision of the Medicare Prescription Drug Benefit to beneficiaries. Please see the supporting documentation, ‘‘Revisions to 2nd Draft of CY 2010 Part D Reporting Requirements’’ document to view a list of current changes. Frequency: Reporting—yearly, quarterly and semi-annually; Affected Public: Business or other for-profit; Number of VerDate Nov<24>2008 14:18 May 21, 2009 Jkt 217001 Respondents: 4,526; Total Annual Responses: 380,184; Total Annual Hours: 157,450. (For policy questions regarding this collection contact Alice Lee-Martin at 410–786–4578. For all other issues call 410–786–1103.) 2. Type of Information Collection Request: Extension of a currently approved collection; Title of Information Collection: Medicare Prescription Drug Benefit Plan Program: Use: Part D plans use the information discussed to comply with the eligibility and associated Part D participating requirements. CMS will use this information to approve contract applications, monitor compliance with contract requirements, make proper payment to plans, and to ensure that correct information is disclosed to enrollees, both potential and current enrollees. Form Number: CMS–10141 (OMB#: 0938–0964); Frequency: Reporting—quarterly, semi-annually and yearly; Affected Public: Business or other for-profits and Individuals or households; Number of Respondents: 19,937,772; Total Annual Responses: 38,152,764; Total Annual Hours: 34,730,676. (For policy questions regarding this collection contact Eugenia Mattison-Gibson at 410–786– 2564. For all other issues call 410–786– 1326.) To obtain copies of the supporting statement and any related forms for the proposed paperwork collections referenced above, access CMS Web site address at https://www.cms.hhs.gov/ PaperworkReductionActof1995, or E-mail your request, including your address, phone number, OMB number, and CMS document identifier, to Paperwork@cms.hhs.gov, or call the Reports Clearance Office on (410) 786– 1326. To be assured consideration, comments and recommendations for the proposed information collections must be received by the OMB desk officer at the address below, no later than 5 p.m. on June 22, 2009: OMB, Office of Information and Regulatory Affairs, Attention: CMS Desk Officer, Fax Number: (202) 395–6974, E-mail: OIRA_submission@omb.eop.gov. Dated: May 15, 2009. Michelle Shortt, Director, Regulations Development Group, Office of Strategic Operations and Regulatory Affairs. [FR Doc. E9–11939 Filed 5–21–09; 8:45 am] BILLING CODE 4120–01–P PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–E–0307] Determination of Regulatory Review Period for Purposes of Patent Extension; INTELENCE AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for INTELENCE 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 https:// 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 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 E:\FR\FM\22MYN1.SGM 22MYN1 erowe on PROD1PC63 with NOTICES Federal Register / Vol. 74, No. 98 / Friday, May 22, 2009 / Notices 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 INTELENCE (etravirine). INTELENCE, in combination with other antiretroviral agents, is indicated for the treatment of HIV–1 infection in treatmentexperienced adult patients who have evidence of viral replication and HIV– 1 strains resistant to an NNRTYI and other retroviral agents. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for INTELENCE (U.S. Patent No. 7,037,917) from Janssen Pharmaceutica, N.V., and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated June 10, 2008, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of INTELENCE 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 period. FDA has determined that the applicable regulatory review period for INTELENCE is 2,235 days. Of this time, 2,050 days occurred during the testing phase of the regulatory review period, while 185 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: December 7, 2001. The applicant claims December 27, 2001, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was December 7, 2001. The applicant was notified by telephone on December 7, 2001, that they were allowed to proceed with clinical trials. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: July 18, 2007. FDA has verified the applicant’s claim that the new drug application (NDA) for VerDate Nov<24>2008 14:18 May 21, 2009 Jkt 217001 INTELENCE (NDA 22–187) was initially submitted on July 18, 2007. 3. The date the application was approved: January 18, 2008. FDA has verified the applicant’s claim that NDA 22–187 was approved on January 18, 2008. 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 404 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 July 21, 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 November 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. Dated: May 13, 2009. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E9–12050 Filed 5–21–09; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Medicare and Medicaid Services [CMS–2900–PN] Medicare and Medicaid Programs; Application by the Community Health Accreditation Program for Continued Deeming Authority for Hospices AGENCY: Centers for Medicare and Medicaid Services, HHS. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 ACTION: 24015 Proposed notice. SUMMARY: This proposed notice acknowledges the receipt of a deeming application from the Community Health Accreditation Program (CHAP) for continued recognition as a national accrediting organization for hospices that wish to participate in the Medicare or Medicaid programs. The statute requires that within 60 days of receipt of an organization’s complete application, we publish a notice that identifies the national accrediting body making the request, describes the nature of the request, and provides at least a 30-day public comment period. DATES: To be assured consideration, comments must be received at one of the addresses provided below, no later than 5 p.m. on June 22, 2009. ADDRESSES: In commenting, please refer to file code CMS–2900–PN. Because of staff and resource limitations, we cannot accept comments by facsimile (FAX) transmission. You may submit comments in one of four ways (please choose only one of the ways listed): 1. Electronically. You may submit electronic comments on this regulation to https://www.regulations.gov. Follow the instructions under the ‘‘More Search Options’’ tab. 2. By regular mail. You may mail written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–2900–PN, P.O. Box 8010, Baltimore, MD 21244–8010. Please allow sufficient time for mailed comments to be received before the close of the comment period. 3. By express or overnight mail. You may send written comments to the following address only: Centers for Medicare & Medicaid Services, Department of Health and Human Services, Attention: CMS–2900–PN, Mail Stop C4–26–05, 7500 Security Boulevard, Baltimore, MD 21244–1850. 4. By hand or courier. If you prefer, you may deliver (by hand or courier) your written comments before the close of the comment period to either of the following addresses: a. For delivery in Washington, DC— Centers for Medicare & Medicaid Services, Department of Health and Human Services, Room 445–G, Hubert H. Humphrey Building, 200 Independence Avenue, SW., Washington, DC 20201. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without Federal government identification, E:\FR\FM\22MYN1.SGM 22MYN1

Agencies

[Federal Register Volume 74, Number 98 (Friday, May 22, 2009)]
[Notices]
[Pages 24014-24015]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E9-12050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0307]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; INTELENCE

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for INTELENCE 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 https://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 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

[[Page 24015]]

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 
INTELENCE (etravirine). INTELENCE, in combination with other 
antiretroviral agents, is indicated for the treatment of HIV-1 
infection in treatment-experienced adult patients who have evidence of 
viral replication and HIV-1 strains resistant to an NNRTYI and other 
retroviral agents. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
INTELENCE (U.S. Patent No. 7,037,917) from Janssen Pharmaceutica, N.V., 
and the Patent and Trademark Office requested FDA's assistance in 
determining this patent's eligibility for patent term restoration. In a 
letter dated June 10, 2008, FDA advised the Patent and Trademark Office 
that this human drug product had undergone a regulatory review period 
and that the approval of INTELENCE 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 period.
    FDA has determined that the applicable regulatory review period for 
INTELENCE is 2,235 days. Of this time, 2,050 days occurred during the 
testing phase of the regulatory review period, while 185 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: 
December 7, 2001. The applicant claims December 27, 2001, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was December 
7, 2001. The applicant was notified by telephone on December 7, 2001, 
that they were allowed to proceed with clinical trials.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: July 18, 2007. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for INTELENCE (NDA 22-187) was initially submitted on July 18, 
2007.
    3. The date the application was approved: January 18, 2008. FDA has 
verified the applicant's claim that NDA 22-187 was approved on January 
18, 2008.
    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 404 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 July 21, 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 November 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.

    Dated: May 13, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-12050 Filed 5-21-09; 8:45 am]
BILLING CODE 4160-01-S

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