Determination of Regulatory Review Period for Purposes of Patent Extension; VEREGEN, 31697-31698 [E8-12296]

Download as PDF 31697 Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices TABLE 1.—ESTIMATED ANNUAL REPORTING BURDEN1—Continued Annual Frequency per Response No. of Respondents 21 CFR Section Total Annual Responses Hours Per Response Total Hours Recall Status Reports and Follow-up 7.53 2,166 4 8,664 10 86,640 Termination of a Recall 7.55(b) 2,166 1 2,166 10 21,660 Total 1 There 216,600 are no capital costs or operating and maintenance costs associated with this collection of information. The annual reporting burdens are explained as follows: accepted by FDA only through FDMS at https://www.regulations.gov. I. Reporting Dated: May 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–12339 Filed 6–2–08; 8:45 am] A. Recall Strategy Request firms develop a recall strategy including provision for public warnings and effectiveness checks. Under this portion of the collection of information, the agency estimates it will receive 2,166 responses annually. B. Firm Initiated Recall and Recall Communications Request firms voluntarily remove or correct foods and drugs (human or animal), cosmetics, medical devices, and biologicals to immediately notify the appropriate FDA district office of such actions. The firm is to provide complete details of the recall reason, risk evaluation, quantity produced, distribution information, firms’ recall strategy and a contact official as well as requires firms to notify their direct accounts of the recall and to provide recipients with a ready means of reporting to the recalling firm. Under these portions of the collection of information, the agency estimates it will receive 2,166 responses annually for each. C. Recall Status Reports Request that recalling firms provide periodic status reports so the FDA can ascertain the progress of the recall. This collection of information will generate approximately 8,664 responses annually. ebenthall on PRODPC60 with NOTICES D. Termination of a Recall Provide the firms an opportunity to request in writing that FDA end the recall. The agency estimates it will receive 2,166 responses annually. 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 VerDate Aug<31>2005 14:18 Jun 02, 2008 Jkt 214001 Dated: May 27, 2008. Jeffrey Shuren, Associate Commissioner for Policy and Planning. [FR Doc. E8–12300 Filed 6–2–08; 8:45 am] BILLING CODE 4160–01–S BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food and Drug Administration [Docket No. FDA–2007–E–0458 (formerly Docket No. 2007E–0144) and Docket No. FDA–2007–E–0460 (formerly Docket No. 2007E–0176)] [Docket No. FDA–2007–E–0335] (formerly Docket No. 2007E–0133) and [Docket No. FDA–2007–E–0227] (formerly Docket No. 2007E–0148) Determination of Regulatory Review Period for Purposes of Patent Extension; VEREGEN Determination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA; Correction AGENCY: Food and Drug Administration, HHS. ACTION: Notice; correction. SUMMARY: The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of May 15, 2008 (73 FR 28119), announcing FDA’s determination of the regulatory review period for TYZEKA. The document published with an incorrect docket number. This document corrects that error. FOR FURTHER INFORMATION CONTACT: Joyce Strong, Office of Policy, Planning and Preparedness (HF–27), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 7630. In FR Doc. E8–10857, published on May 15, 2008 (73 FR 28119), the following correction is made: On page 28119, in the third column, in the Docket No. heading, ‘‘Docket No. FDA–2007–E–0035’’ is corrected to read ‘‘Docket No. FDA–2007–E–0335’’. SUPPLEMENTARY INFORMATION: PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for VEREGEN 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–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 E:\FR\FM\03JNN1.SGM 03JNN1 ebenthall on PRODPC60 with NOTICES 31698 Federal Register / Vol. 73, No. 107 / Tuesday, June 3, 2008 / Notices 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)(1)(B). FDA approved for marketing the human drug product VEREGEN (kunecatechins). VEREGEN is indicated for the topical treatment of external genital and perianal warts in immunocompetent patients 18 years and older. Subsequent to this approval, the Patent and Trademark Office received patent term restoration applications for VEREGEN (U.S. Patent Nos. 5,795,911 and 5,968,973) from Mitsui Norin Co., Ltd., and Cancer Institute (Hospital), Chinese Academy of Medical Sciences, and the Patent and Trademark Office requested FDA’s assistance in determining these patents’ eligibility for patent term restoration. In a letter dated July 24, 2007, FDA advised the Patent and Trademark Office that this human drug product had undergone a regulatory review period and that the approval of VEREGEN 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 VEREGEN is 3,002 days. Of this time, 2,605 days occurred during the testing phase of the regulatory review period, VerDate Aug<31>2005 14:18 Jun 02, 2008 Jkt 214001 while 397 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: August 14, 1998. The applicant claims August 13, 1998, as the date the investigational new drug application (IND) became effective. However, FDA records indicate that the IND effective date was August 14, 1998, which was 30 days after FDA receipt of the IND. 2. The date the application was initially submitted with respect to the human drug product under section 505(b) of the act: September 30, 2005. The applicant claims September 23, 2005, as the date the new drug application (NDA) for VEREGEN (NDA 21–902) was initially submitted. However, FDA records indicate that NDA 21–902 was submitted on September 30, 2005. 3. The date the application was approved: October 31, 2006. FDA has verified the applicant’s claim that NDA 21–902 was approved on October 31, 2006. 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 1,300 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 August 4, 2008. 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 December 1, 2008. 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. PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 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 through FDMS only. Dated: April 28, 2008. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E8–12296 Filed 6–2–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Food Labeling Workshop; Public Workshop AGENCY: Food and Drug Administration, HHS. ACTION: Notice of public workshop. SUMMARY: The Food and Drug Administration (FDA), Office of Regulatory Affairs, Southwest Regional Small Business Representative (SWR SBR) Program, in collaboration with The University of Arkansas (UA), is announcing a public workshop entitled ‘‘Food Labeling Workshop.’’ This public workshop is intended to provide information about FDA food labeling regulations and other related subjects to the regulated industry, particularly small businesses and startups. Date and Time: This public workshop will be held on August 12, 2008, from 8 a.m. to 5 p.m., and on August 13, from 8 a.m. to 4 p.m. Location: The public workshop will be held at the Continuing Education Center, 2 East Center St., Fayetteville, AR (located downtown). Contact: David Arvelo, Small Business Representative, Food and Drug Administration, Southwest Regional Office, 4040 North Central Expressway, suite 900, Dallas, TX 75204, 214–253– 4952, FAX: 214–253–4970, or email: david.arvelo@fda.hhs.gov. For information on accommodation options, contact Steven C. Seideman, 2650 North Young Ave., Institute of Food Science & Engineering, University of Arkansas, Fayetteville, AR 72704, 479–575–4221, FAX: 479–575–2165, or email: seideman@uark.edu. Registration: You are encouraged to register by July 29, 2008. The University of Arkansas requires a $150 registration fee to cover the cost of facilities, materials, and breaks. Seats are limited; E:\FR\FM\03JNN1.SGM 03JNN1

Agencies

[Federal Register Volume 73, Number 107 (Tuesday, June 3, 2008)]
[Notices]
[Pages 31697-31698]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-12296]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0458 (formerly Docket No. 2007E-0144) and Docket 
No. FDA-2007-E-0460 (formerly Docket No. 2007E-0176)]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for VEREGEN 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-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

[[Page 31698]]

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)(1)(B).
    FDA approved for marketing the human drug product VEREGEN 
(kunecatechins). VEREGEN is indicated for the topical treatment of 
external genital and perianal warts in immunocompetent patients 18 
years and older. Subsequent to this approval, the Patent and Trademark 
Office received patent term restoration applications for VEREGEN (U.S. 
Patent Nos. 5,795,911 and 5,968,973) from Mitsui Norin Co., Ltd., and 
Cancer Institute (Hospital), Chinese Academy of Medical Sciences, and 
the Patent and Trademark Office requested FDA's assistance in 
determining these patents' eligibility for patent term restoration. In 
a letter dated July 24, 2007, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of VEREGEN 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 
VEREGEN is 3,002 days. Of this time, 2,605 days occurred during the 
testing phase of the regulatory review period, while 397 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: 
August 14, 1998. The applicant claims August 13, 1998, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was August 14, 1998, 
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: September 30, 
2005. The applicant claims September 23, 2005, as the date the new drug 
application (NDA) for VEREGEN (NDA 21-902) was initially submitted. 
However, FDA records indicate that NDA 21-902 was submitted on 
September 30, 2005.
    3. The date the application was approved: October 31, 2006. FDA has 
verified the applicant's claim that NDA 21-902 was approved on October 
31, 2006.
    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 1,300 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 August 4, 2008. 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 December 1, 
2008. 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 
through FDMS only.

    Dated: April 28, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-12296 Filed 6-2-08; 8:45 am]
BILLING CODE 4160-01-S

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