Determination of Regulatory Review Period for Purposes of Patent Extension; ROTATEQ, 33095-33096 [E8-13109]

Download as PDF Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Administration for Children and Families Task Force on Community Preventive Services President’s Committee for People With Intellectual Disabilities Notice of Meeting In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention (CDC) announces the following meeting: President’s Committee for People with Intellectual Disabilities (PCPID). ACTION: Notice of Quarterly Meeting. Name: Task Force on Community Preventive Services. Times and Dates: 8 a.m.–6 p.m. EST, June 25, 2008. 8 a.m.–1 p.m. EST, June 26, 2008. Place: Centers for Disease Control and Prevention, 2500 Century Parkway, Atlanta, Georgia 30345. Status: Open to the public, limited only by the space available. Purpose: The mission of the Task Force is to develop and publish the Guide to Community Preventive Services (Community Guide), which consists of systematic reviews of the best available scientific evidence and associated recommendations regarding what works in the delivery of essential public health services. Topics include: • Interventions to reduce vaccinepreventable diseases: Updates to existing reviews • Asthma—home visitation interventions • Alcohol—hours and days of sale • Worksite—On-site access to influenza vaccination • Folic Acid—Community-wide education resupplements Agenda items are subject to change as priorities dictate. Persons interested in reserving a space for this meeting should call Charmen Crawford at 404–498–2498 by close of business on June 20, 2008. Contact person for additional information: Charmen Crawford, Coordinating Center for Health Information and Services, National Center for Health Marketing, Office of the Director, 1600 Clifton Road, M/S E–69, Atlanta, GA 30333, phone: 404–498–2498. Dated: June 4, 2008. James D. Seligman, Chief Information Officer, Centers for Disease Control and Prevention. [FR Doc. E8–13114 Filed 6–10–08; 8:45 am] sroberts on PROD1PC70 with NOTICES BILLING CODE 4163–18–P VerDate Aug<31>2005 16:13 Jun 10, 2008 Jkt 214001 AGENCY: June 25, 2008, from 9 a.m. to 5 p.m. EST; June 26, 2008, from 2:30 p.m. to 5 p.m.; and June 27, 2008, from 8:30 a.m. to 12 p.m. EST. The meeting will be open to the public. ADDRESSES: The meeting will be held in Room 800 of the Hubert H. Humphrey Building, 200 Independence Ave., SW., Washington, DC 20201. Individuals who would like to participate via conference call may do so by dialing 888–810– 4935, passcode: PCPID. Individuals who will need accommodations for a disability in order to attend the meeting (e.g., sign language interpreting services, assistive listening devices, materials in alternative format such as large print or Braille) should notify MJ Karimi via email at Madjid.KarimieAsl@ACF.hhs.gov, or via telephone at 202–619–0634, no later than June 18, 2008. PCPID will attempt to meet requests made after that date, but cannot guarantee availability. All meeting sites are barrier free. Agenda: PCPID will meet to swear in the new members of the Committee and set the agenda for the coming year. Additional Information: For further information, please contact Sally D. Atwater, Executive Director, President’s Committee for People with Intellectual Disabilities, The Aerospace Center, Second Floor West, 370 L’Enfant Promenade, SW., Washington, DC 20447. Telephone: 202–619–0634. Fax: 202–205–9591. E-mail: satwater@acf.hhs.gov. SUPPLEMENTARY INFORMATION: PCPID acts in an advisory capacity to the President and the Secretary of Health and Human Services on a broad range of topics relating to programs, services and supports for persons with intellectual disabilities. PCPID, by Executive Order, is responsible for evaluating the adequacy of current practices in programs, services and supports for persons with intellectual disabilities, and for reviewing legislative proposals that impact the quality of life experienced by citizens with intellectual disabilities and their families. 33095 Dated: June 5, 2008. Sally D. Atwater, Executive Director, President’s Committee for People with Intellectual Disabilities. [FR Doc. E8–13091 Filed 6–10–08; 8:45 am] BILLING CODE 4184–01–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2006–E–0130] (formerly Docket No. 2006E–0486) DATES: PO 00000 Frm 00031 Fmt 4703 Sfmt 4703 Determination of Regulatory Review Period for Purposes of Patent Extension; ROTATEQ AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for ROTATEQ 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 biological product. Submit written or electronic 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 ADDRESSES: E:\FR\FM\11JNN1.SGM 11JNN1 sroberts on PROD1PC70 with NOTICES 33096 Federal Register / Vol. 73, No. 113 / Wednesday, June 11, 2008 / Notices biological products, the testing phase begins when the exemption to permit the clinical investigations of the biological becomes effective and runs until the approval phase begins. The approval phase starts with the initial submission of an application to market the human biological product and continues until FDA grants permission to market the biological 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 biological 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 biologic product ROTATEQ (Rotavirus Vaccine, Live, Oral, Pentavalent). ROTATEQ is indicated for the prevention of rotavirus gastroenteritis in infants and children caused by the serotypes G1, G2, G3, and G4, when administered as a 3-dose series to infants between the ages of 6 to 32 weeks. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for ROTATEQ (U.S. Patent No. 5,626,851) from the Wistar Institute of Anatomy and Biology and the Children’s Hospital of Philadelphia, and the Patent and Trademark Office requested FDA’s assistance in determining this patent’s eligibility for patent term restoration. In a letter dated February 28, 2007, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of ROTATEQ 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 ROTATEQ is 4,577 days. Of this time, 4,272 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 (21 U.S.C. 355(i)) became effective: July 26, 1993. The applicants claim June 18, 1993, as the date the investigational new drug application (IND) became effective. VerDate Aug<31>2005 16:13 Jun 10, 2008 Jkt 214001 However, FDA records indicate that the IND effective date was July 26, 1993, when the IND was removed from clinical hold and studies in humans could proceed. 2. The date the application was initially submitted with respect to the human biological product under section 351 of the Public Health Service Act (42 U.S.C. 262): April 5, 2005. FDA has verified the applicants’ claim that the biologics license application (BLA) for ROTATEQ (BLA 125122) was initially submitted on April 5, 2005. 3. The date the application was approved: February 3, 2006. FDA has verified the applicants’ claim that BLA 125122 was approved on February 3, 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, these applicants seek 1,751 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 11, 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 8, 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 only through FDMS at http://www.regulations.gov. PO 00000 Frm 00032 Fmt 4703 Sfmt 4703 Dated: May 21, 2008. Jane A. Axelrad, Associate Director for Policy, Center for Drug Evaluation and Research. [FR Doc. E8–13109 Filed 6–10–08; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA–2008–N–0324] Summaries of Medical and Clinical Pharmacology Reviews of Pediatric Studies; Availability AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) is announcing the availability of summaries of medical and clinical pharmacology reviews of pediatric studies submitted in supplements for ABILIFY (aripiprazole), ANDROGEL (testosterone), and DIOVAN (valsartan). These summaries are being made available consistent with the Best Pharmaceuticals for Children Act, enacted in 2002, (the 2002 BPCA). For all pediatric supplements submitted under the 2002 BPCA, the 2002 BPCA required FDA to make available to the public, including by publication in the Federal Register, a summary of the medical and clinical pharmacology reviews of the pediatric studies conducted for the supplement. ADDRESSES: Submit written requests for single copies of the summaries to the Division of Drug Information, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver Spring, MD 20993–0002. Please specify by product name which summary or summaries you are requesting. Send one self-addressed adhesive label to assist that office in processing your requests. See the SUPPLEMENTARY INFORMATION section for electronic access to the summaries. FOR FURTHER INFORMATION CONTACT: Grace Carmouze, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 6460, Silver Spring, MD 20993–0002, 301– 796–0700, e-mail: grace.carmouze@fda.hhs.gov. SUPPLEMENTARY INFORMATION: I. Background FDA is announcing the availability of summaries of medical and clinical E:\FR\FM\11JNN1.SGM 11JNN1

Agencies

[Federal Register Volume 73, Number 113 (Wednesday, June 11, 2008)]
[Notices]
[Pages 33095-33096]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-13109]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2006-E-0130] (formerly Docket No. 2006E-0486)


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ROTATEQ 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 biological product.

ADDRESSES:  Submit written or electronic 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

[[Page 33096]]

biological products, the testing phase begins when the exemption to 
permit the clinical investigations of the biological becomes effective 
and runs until the approval phase begins. The approval phase starts 
with the initial submission of an application to market the human 
biological product and continues until FDA grants permission to market 
the biological 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 biological 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 biologic product ROTATEQ 
(Rotavirus Vaccine, Live, Oral, Pentavalent). ROTATEQ is indicated for 
the prevention of rotavirus gastroenteritis in infants and children 
caused by the serotypes G1, G2, G3, and G4, when administered as a 3-
dose series to infants between the ages of 6 to 32 weeks. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for ROTATEQ (U.S. Patent No. 5,626,851) from 
the Wistar Institute of Anatomy and Biology and the Children's Hospital 
of Philadelphia, and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated February 28, 2007, FDA advised the 
Patent and Trademark Office that this human biological product had 
undergone a regulatory review period and that the approval of ROTATEQ 
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 
ROTATEQ is 4,577 days. Of this time, 4,272 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 (21 U.S.C. 355(i)) became effective: July 26, 
1993. The applicants claim June 18, 1993, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was July 26, 1993, 
when the IND was removed from clinical hold and studies in humans could 
proceed.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): April 5, 2005. FDA has verified the 
applicants' claim that the biologics license application (BLA) for 
ROTATEQ (BLA 125122) was initially submitted on April 5, 2005.
    3. The date the application was approved: February 3, 2006. FDA has 
verified the applicants' claim that BLA 125122 was approved on February 
3, 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, these applicants seek 1,751 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 11, 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 8, 
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 only 
through FDMS at http://www.regulations.gov.

    Dated: May 21, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-13109 Filed 6-10-08; 8:45 am]
BILLING CODE 4160-01-S