Mine Safety and Health Research Advisory Committee, 15698-15699 [E7-6008]

Download as PDF 15698 Federal Register / Vol. 72, No. 62 / Monday, April 2, 2007 / Notices DEPARTMENT OF HEALTH AND HUMAN SERVICES following meetings of the aforementioned subcommittee and committee. Centers for Disease Control and Prevention Name: Science and Program Review Subcommittee. Times and Date: 10:30 a.m.–10:45 a.m., April 30, 2007 (Open). 10:45 a.m.–2 p.m., April 30, 2007 (Closed). Place: Koger Center, Vanderbilt Building, Room 1004 A/B, 2939 Flowers Road, South, Atlanta, GA 30341. Purpose: The SPRS provides advice on the needs, structure, progress and performance of programs of the National Center for Injury Prevention and Control (NCIPC). Matters to be Discussed: The subcommittee will meet April 30, 2007, to provide a secondary review of, discuss, and evaluate grant applications and cooperative agreements received in response to three Request for Applications (RFAs) related to the following individual research grant and cooperative agreement applications: 07001, Grants for Injury Control Research Centers; 07009, Dissertation Grant Awards for Doctoral Candidates for Violence-Related Injury Prevention Research in Minority Communities; and 07010, Research for Preventing Violence-Related Injury. In addition, the ACIPC will meet via teleconference on April 30, 2007, to vote on the recommendations of the SPRS regarding the RFAs. Agenda items are subject to change as priorities dictate. Name: Advisory Committee for Injury Prevention and Control. Times and Date: 3 p.m.–3:15 p.m., April 30, 2007 (Open). 3:15 p.m.–4:30 p.m., April 30, 2007 (Closed). Place: Koger Center, Vanderbilt Building, Room 1004 A/B, 2939. Purpose: The committee advises and makes recommendations to the Secretary, Department of Health and Human Services, the Director, CDC, and the Director, NCIPC, regarding feasible goals for the prevention and control of injury. The committee makes recommendations regarding policies, strategies, objectives, and priorities, and reviews progress toward injury prevention and control. Matters to be Discussed: Agenda items for the open portion include the call to order and introductions and request for public comments. Beginning at 3:15 p.m., April 30, 2007, through 4:30 p.m, during the closed portion, the Committee will vote on the results of the secondary review. This portion of the meeting will be closed to the public in accordance with the provisions set forth in section 552b(c)(4) and (b), title 5 U.S.C., and the Determination of the Acting Director, Management Analysis and Services Office, CDC pursuant to Pub L. 92–463. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Ms. Amy Harris, Executive Secretary, ACIPC, NCIPC, CDC, 4770 Buford Highway, NE., M/S K61, Atlanta, Georgia 30341–3724, telephone (770) 488–4936. Disease, Disability, and Injury Prevention and Control Special Emphasis Panel (SEP): Evaluation of the Immune Response to a Modified Dosing Schedule of the Quadrivalent HPV Vaccine, Potential Extramural Project (PEP) 2007–R–03 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 aforementioned meeting. Time and Date: 12 p.m.–4 p.m., May 17, 2007 (Closed). Place: Teleconference. Status: The meeting will be closed to the public in accordance with provisions set forth in Section 552b(c)(4) and (6), Title 5 U.S.C., and the Determination of the Director, Management Analysis and Services Office, CDC, pursuant to Public Law 92–463. Matters To Be Discussed: The meeting will include the review, discussion, and evaluation of ‘‘The Immune Response to a Modified Dosing Schedule of the Quadrivalent HPV Vaccine,’’ PEP 2007–R–03. Contact Person for More Information: Christine J. Morrison, PhD, Scientific Review Administrator, Office of the Chief Science Officer, CDC, 1600 Clifton Road NE, Mailstop D–72, Atlanta, GA 30333, Telephone (404) 639–3098. 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. E7–6036 Filed 3–30–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES hsrobinson on PROD1PC76 with NOTICES Centers for Disease Control and Prevention (CDC) Meetings of the Advisory Committee for Injury Prevention and Control (ACIPC), and Its Subcommittee, the Science and Program Review Subcommittee (SPRS or the Subcommittee) In accordance with Section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92–463), the Centers for Disease Control and Prevention announces the VerDate Aug<31>2005 18:39 Mar 30, 2007 Jkt 211001 The Director, Management Analysis and Services Office, has been delegated the PO 00000 Frm 00055 Fmt 4703 Sfmt 4703 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. E7–6037 Filed 3–30–07; 8:45 am] BILLING CODE 4163–18–P DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Mine Safety and Health Research Advisory Committee 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 of the aforementioned committee. Times and Dates: 8:45 a.m.–5:15 p.m., May 2, 2007. 8:30 a.m.–12:15 p.m., May 3, 2007. Place: Pittsburgh Airport Marriott, 777 Aten Road, Coraopolis, PA, 15108, telephone (412) 788–8800, fax (412) 788–6299. Status: Open to the public, limited only by the space available. The meeting room accommodates approximately 50 people. Purpose: This committee is charged with providing advice to the Secretary, Department of Health and Human Services; the Director, CDC; and the Director, National Institute for Occupational Safety and Health (NIOSH), on priorities in mine safety and health research, including grants and contracts for such research, 30 U.S.C. 812(b)(2), Section 102(b)(2). Matters to be Discussed: The meeting will focus on Communications and Tracking, update on Refuge Chamber Activities, Mine Seals Research, other Research Projects Related to Disaster Prevention and Response and Behavioral Research on Mine Escape. The agenda will also include an update report from the Associate Director for Mining. Agenda items are subject to change as priorities dictate. Contact Person for More Information: Jeffery L. Kohler, PhD, Executive Secretary, MSHRAC, NIOSH, CDC, 626 Cochrans Mill Road, telephone (412) 386–5301, fax (412) 386–5300. 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 the Centers for Disease Control and Prevention and the Agency for Toxic Substances and Disease Registry. E:\FR\FM\02APN1.SGM 02APN1 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]
[Pages 15698-15699]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-6008]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Disease Control and Prevention


Mine Safety and Health Research Advisory Committee

    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 of the aforementioned 
committee.

    Times and Dates:

8:45 a.m.-5:15 p.m., May 2, 2007.
8:30 a.m.-12:15 p.m., May 3, 2007.

    Place: Pittsburgh Airport Marriott, 777 Aten Road, Coraopolis, 
PA, 15108, telephone (412) 788-8800, fax (412) 788-6299.
    Status: Open to the public, limited only by the space available. 
The meeting room accommodates approximately 50 people.
    Purpose: This committee is charged with providing advice to the 
Secretary, Department of Health and Human Services; the Director, 
CDC; and the Director, National Institute for Occupational Safety 
and Health (NIOSH), on priorities in mine safety and health 
research, including grants and contracts for such research, 30 
U.S.C. 812(b)(2), Section 102(b)(2).
    Matters to be Discussed: The meeting will focus on 
Communications and Tracking, update on Refuge Chamber Activities, 
Mine Seals Research, other Research Projects Related to Disaster 
Prevention and Response and Behavioral Research on Mine Escape. The 
agenda will also include an update report from the Associate 
Director for Mining.
    Agenda items are subject to change as priorities dictate.
    Contact Person for More Information: Jeffery L. Kohler, PhD, 
Executive Secretary, MSHRAC, NIOSH, CDC, 626 Cochrans Mill Road, 
telephone (412) 386-5301, fax (412) 386-5300.
    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 the Centers for Disease Control and Prevention 
and the Agency for Toxic Substances and Disease Registry.


[[Page 15699]]


    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]
BILLING CODE 4163-18-P

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.