Board of Scientific Counselors, National Center for Health Statistics, 15699 [E7-6022]

Download as PDF Federal Register / Vol. 72, No. 62 / Monday, April 2, 2007 / Notices Dated: March 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office, Centers for Disease Control and Prevention (CDC). [FR Doc. E7–6008 Filed 3–30–07; 8:45 am] Dated: March 26, 2007. Elaine L. Baker, Acting Director, Management Analysis and Services Office Centers for Disease Control and Prevention. [FR Doc. E7–6022 Filed 3–30–07; 8:45 am] BILLING CODE 4163–18–P BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Food and Drug Administration Board of Scientific Counselors, National Center for Health Statistics Determination of Regulatory Review Period for Purposes of Patent Extension; KEPIVANCE [Docket No. 2005E–0245] hsrobinson on PROD1PC76 with NOTICES 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), National Center for Health Statistics (NCHS) announces the following meeting of the aforementioned committee. Times and Dates: 2 p.m.–5:30 p.m., April 26, 2007. 8:30 a.m.–2 p.m., April 27, 2007. Place: NCHS Headquarters, 3311 Toledo Road, Hyattsville, Maryland 20782. Status: Open to the public, and limited only to the space available. The meeting room accommodates approximately 100 people. Purpose: This committee is charged with providing advice and making recommendations to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, NCHS, regarding the scientific and technical program goals and objectives, strategies, and priorities of NCHS. Matters to be Discussed: The agenda will include welcome remarks by the Director, NCHS; introduction of members and key NCHS staff; scientific presentations and discussions; continued discussion of the review of the natality program; discussion of upcoming program reviews and an open session for comments from the public. Requests to make oral presentations should be submitted in writing to the contact person listed below. All requests must contain the name, address, telephone number, and organizational affiliation of the presenter. Written comments should not exceed five single-spaced typed pages in length and must be received by April 13, 2007. The agenda items are subject to change as priorities dictate. Contact Person For More Information: Virginia S. Cain, Ph.D., Director of Extramural Research, NCHS/CDC, 3311 Toledo Road, Room 7211, Hyattsville, Maryland 20782, telephone (301) 458–4500, fax (301) 458–4020. The Director, Management Analysis and Services Office, has been delegated the authority to sign Federal Register notices pertaining to announcements of meetings and other committee management activities for both CDC and the Agency for Toxic Substances and Disease Registry. VerDate Aug<31>2005 18:39 Mar 30, 2007 Jkt 211001 AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The Food and Drug Administration (FDA) has determined the regulatory review period for KEPIVANCE 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 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.fda.gov/dockets/ecomments. FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory Policy (HFD–7), Food and Drug Administration, 5600 Fishers Lane, Rockville, 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 biological products, the testing phase PO 00000 Frm 00056 Fmt 4703 Sfmt 4703 15699 begins when the exemption to permit the clinical investigations of the human biological product becomes effective and runs until the approval phase begins. The approval phase starts with the initial complete submission of an application to market the human biological 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 biological 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 biological product KEPIVANCE (palifermin). KEPIVANCE is indicated to decrease the incidence and duration of severe oral mucositis in patients with hematologic malignancies receiving myelotoxic therapy requiring hematopoietic stem cell support. Subsequent to this approval, the Patent and Trademark Office received a patent term restoration application for KEPIVANCE (U.S. Patent No. 5,677,278) from Chiron Corp., 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 14, 2006, FDA advised the Patent and Trademark Office that this human biological product had undergone a regulatory review period and that the approval of KEPIVANCE 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 KEPIVANCE is 3,303 days. Of this time, 3,119 days occurred during the testing phase of the regulatory review period, while 184 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 2, 1995. FDA has verified the applicant’s claim that the date the investigational new drug application became effective was on December 2, 1995. 2. The date the application was initially submitted with respect to the human biological product under section E:\FR\FM\02APN1.SGM 02APN1

Agencies

[Federal Register Volume 72, Number 62 (Monday, April 2, 2007)]
[Notices]
[Page 15699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6022]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Board of Scientific Counselors, National Center for Health 
Statistics

    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), National Center for Health Statistics (NCHS) 
announces the following meeting of the aforementioned committee.

    Times and Dates: 2 p.m.-5:30 p.m., April 26, 2007. 8:30 a.m.-2 
p.m., April 27, 2007.
    Place: NCHS Headquarters, 3311 Toledo Road, Hyattsville, 
Maryland 20782.
    Status: Open to the public, and limited only to the space 
available. The meeting room accommodates approximately 100 people.
    Purpose: This committee is charged with providing advice and 
making recommendations to the Secretary, Department of Health and 
Human Services; the Director, CDC; and the Director, NCHS, regarding 
the scientific and technical program goals and objectives, 
strategies, and priorities of NCHS.
    Matters to be Discussed: The agenda will include welcome remarks 
by the Director, NCHS; introduction of members and key NCHS staff; 
scientific presentations and discussions; continued discussion of 
the review of the natality program; discussion of upcoming program 
reviews and an open session for comments from the public.
    Requests to make oral presentations should be submitted in 
writing to the contact person listed below. All requests must 
contain the name, address, telephone number, and organizational 
affiliation of the presenter.
    Written comments should not exceed five single-spaced typed 
pages in length and must be received by April 13, 2007.
    The agenda items are subject to change as priorities dictate.
    Contact Person For More Information: Virginia S. Cain, Ph.D., 
Director of Extramural Research, NCHS/CDC, 3311 Toledo Road, Room 
7211, Hyattsville, Maryland 20782, telephone (301) 458-4500, fax 
(301) 458-4020.
    The Director, Management Analysis and Services Office, has been 
delegated the authority to sign Federal Register notices pertaining 
to announcements of meetings and other committee management 
activities for both CDC and the Agency for Toxic Substances and 
Disease Registry.

    Dated: March 26, 2007.
Elaine L. Baker,
Acting Director, Management Analysis and Services Office Centers for 
Disease Control and Prevention.
[FR Doc. E7-6022 Filed 3-30-07; 8:45 am]
BILLING CODE 4163-18-P

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