National Cancer Institute; Notice of Charter Renewal, 5763 [2015-01976]

Download as PDF 5763 Federal Register / Vol. 80, No. 22 / Tuesday, February 3, 2015 / Notices than the risk of using the reference product without such alternation or switch. In addition to the collection of information regarding the submission of a 351(k) application for a proposed biosimilar or interchangeable biological product, section 351(l) of the BPCI Act establishes procedures for identifying and resolving patent disputes involving applications submitted under section 351(k) of the PHS Act. The burden estimates for the patent provisions under section 351(l)(6)(C) of the BPCI Act are included in table 1 of this document and are based on the estimated number of 351(k) biosimilar respondents. Based on similar reporting requirements, FDA estimates this notification will take 2 hours. A summary of the collection of information requirements under section 351(l)(6)(C) follows: Not later than 30 days after a complaint from the reference product sponsor is served to a 351(k) applicant in an action for patent infringement described under 351(l)(6), section 351(l)(6)(C) requires that the 351(k) applicant provide the Secretary with notice and a copy of such complaint. The Secretary shall publish in the Federal Register notice any complaint received under section 351(l)(6)(C)(i). Based on the number of 351(k) applications FDA received through FY 2014, we estimate that we will receive approximately five 351(k) applications annually. The number of respondents submitting 351(k) applications is based on the number of sponsors submitting 351(k) applications through FY 2014. In making these estimates, FDA has taken into account, among other things, the expiration dates of patents that relate to potential reference products, and general market interest in biological products that could be candidates for 351(k) applications. FDA estimates the burden of this collection of information as follows: TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1 351(k)(2)(A)(i) and 351(k)(2)(A)(iii) Biosimilar Product Applications ........................................................................... 351(k)(2)(B) and (k)(4) Interchangeable Product Applications or Supplements ....................................................... 351(l)(6)(C) Patent Infringement Notifications ..................... Total .............................................................................. 1 There Number of responses per respondent Number of respondents 351(k) Applications (42 U.S.C. 262(k)) Total hours 5 1 5 860 4,300 2 5 1 1 2 5 860 2 1,720 10 ........................ ........................ ........................ ........................ 6,030 are no capital costs or operating and maintenance costs associated with this collection of information. Dated: January 28, 2015. Leslie Kux, Associate Commissioner for Policy. Advisory Committee Policy, Office of the Director, National Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, Maryland 20892 (Mail Stop Code 4875), Telephone (301) 496–2123, or spaethj@od.nih.gov. [FR Doc. 2015–02025 Filed 2–2–15; 8:45 am] BILLING CODE 4164–01–P Dated: January 28, 2015. Melanie J. Gray, Program Analyst, Office of Federal Advisory Committee Policy. DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health [FR Doc. 2015–01976 Filed 2–2–15; 8:45 am] National Cancer Institute; Notice of Charter Renewal rljohnson on DSK3VPTVN1PROD with NOTICES Average burden per response Total annual responses BILLING CODE 4140–01–P In accordance with Title 41 of the U.S. Code of Federal Regulations, Section 102–3.65(a), notice is hereby given that the Charter for the National Cancer Institute Council of Research Advocates (formerly known as the National Cancer Institute Director’s Consumer Liaison Group) was renewed for an additional two-year period on August 17, 2014. It is determined that the National Cancer Institute Council of Research Advocates is in the public interest in connection with the performance of duties imposed on the National Institutes of Health by law, and that these duties can best be performed through the advice and counsel of this group. Inquiries may be directed to Jennifer Spaeth, Director, Office of Federal DEPARTMENT OF HEALTH AND HUMAN SERVICES VerDate Sep<11>2014 14:46 Feb 02, 2015 Jkt 235001 National Institutes of Health National Institute of Environmental Health Sciences; Notice of Closed Meeting Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting. The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning PO 00000 Frm 00036 Fmt 4703 Sfmt 4703 individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy. Name of Committee: National Institute of Environmental Health Sciences Special Emphasis Panel; Review of Superfund Hazardous Research and Training Programs. Date: February 25–27, 2015. Time: 8:00 a.m. to 6:00 p.m. Agenda: To review and evaluate grant applications. Place: Sheraton Chapel Hill Hotel, One Europa Drive, Chapel Hill, NC 27514. Contact Person: Leroy Worth, Ph.D., Scientific Review Officer, Scientific Review Branch, Division of Extramural Research and Training, Nat. Institute of Environmental Health Sciences, P.O. Box 12233, MD EC–30/ Room 3171, Research Triangle Park, NC 27709, (919) 541–0670, worth@niehs.nih.gov. (Catalogue of Federal Domestic Assistance Program Nos. 93.115, Biometry and Risk Estimation—Health Risks from Environmental Exposures; 93.142, NIEHS Hazardous Waste Worker Health and Safety Training; 93.143, NIEHS Superfund Hazardous Substances—Basic Research and Education; 93.894, Resources and Manpower Development in the Environmental Health Sciences; 93.113, Biological Response to Environmental Health Hazards; 93.114, Applied Toxicological Research and Testing, National Institutes of Health, HHS) E:\FR\FM\03FEN1.SGM 03FEN1

Agencies

[Federal Register Volume 80, Number 22 (Tuesday, February 3, 2015)]
[Notices]
[Page 5763]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2015-01976]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

National Institutes of Health


National Cancer Institute; Notice of Charter Renewal

    In accordance with Title 41 of the U.S. Code of Federal 
Regulations, Section 102-3.65(a), notice is hereby given that the 
Charter for the National Cancer Institute Council of Research Advocates 
(formerly known as the National Cancer Institute Director's Consumer 
Liaison Group) was renewed for an additional two-year period on August 
17, 2014.
    It is determined that the National Cancer Institute Council of 
Research Advocates is in the public interest in connection with the 
performance of duties imposed on the National Institutes of Health by 
law, and that these duties can best be performed through the advice and 
counsel of this group.
    Inquiries may be directed to Jennifer Spaeth, Director, Office of 
Federal Advisory Committee Policy, Office of the Director, National 
Institutes of Health, 6701 Democracy Boulevard, Suite 1000, Bethesda, 
Maryland 20892 (Mail Stop Code 4875), Telephone (301) 496-2123, or 
spaethj@od.nih.gov.

    Dated: January 28, 2015.
Melanie J. Gray,
Program Analyst, Office of Federal Advisory Committee Policy.
[FR Doc. 2015-01976 Filed 2-2-15; 8:45 am]
BILLING CODE 4140-01-P

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