Memorandum of Understanding Between the U.S. Food and Drug Administration, the National Cancer Institute, and the National Institute of Standards and Technology, 50072-50077 [06-7127]

Download as PDF 50072 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices either be issued on a Notice of Grant Award (PHS 5152) signed by the FDA Chief Grants Management Officer and be sent to the applicant by mail or transmitted electronically. 2. Administrative and National Policy Requirements These agreements will be subject to all policies and requirements that govern the research grant programs of PHS, including provisions of 42 CFR part 52, 45 CFR parts 74 and 92, and the PHS Grants Policy Statement. Applicants must adhere to the requirements of this notice. Special terms and conditions regarding FDA regulatory requirements and adequate progress of the study may be part of the awards notice. PHS strongly encourages all grant recipients to provide a smoke-free workplace and to discourage the use of all tobacco products. This is consistent with the PHS mission to protect and advance the physical and mental health of the American people. FDA is committed to achieving the health promotion and disease prevention objectives of ‘‘Healthy People 2010,’’ a national effort designed to reduce morbidity and mortality and to improve quality of life. Applicants may obtain a paper copy of the ‘‘Healthy People 2010’’ objectives, vols. I and II, for $70 ($87.50 foreign) S/N 017–000– 00550–9, by writing to the Superintendent of Documents, P.O. Box 371954, Pittsburgh, PA 15250–7954. Telephone orders can be placed to 202– 512–2250. The document is also available in CD–ROM format, S/N 017– 001–00549–5 for $19 ($23.50 foreign) as well as on the Internet at https:// www.healthypeople.gov/ under ‘‘Publications.’’ (FDA has verified the Web site address, but FDA is not responsible for subsequent changes to the Web site after this document publishes in the Federal Register.) 3. Reporting rmajette on PROD1PC67 with NOTICES1 A. Reporting Requirements The original and two copies of an annual Financial Status Report (FSR) (SF–269) must be sent to FDA’s grants management officer within 90 days of the budget period end date of the grant. Failure to file the FSR in a timely fashion will be grounds for suspension or termination of the grant. A final FSR will be due 90 days after the expiration of the project period as noted on the Notice of Grant Award. For continuing cooperative agreements, quarterly reports and an annual program progress report are also required. For such cooperative VerDate Aug<31>2005 15:15 Aug 23, 2006 Jkt 208001 agreements, the noncompeting continuation application (SF 424/PHS 5161–1) will be considered the program progress report for the fourth quarter of the budget period. Quarterly progress reports must contain, but are not limited to the following: 1. A status report on the installation, training, and operational readiness of any equipment that is provided; 2. A summary report on any proficiency testing performed; 3. A summary status of samples analyzed and time to complete individual sample testing; and 4. A summary description of any other testing performed on the equipment. A final program progress report, FSR, and invention statement must be submitted within 90 days after the expiration of the project period as noted on the Notice of Grant Award. The final program progress report must provide full written documentation of the project, and summaries of laboratory operations, as described in the grant application. The documentation must be in a form and contain sufficient detail such that other State, local, and tribal government FERN laboratories could reproduce the final project. B. Monitoring Activities The program project officer will monitor grantees periodically. The monitoring may be in the form of telephone conversations, e-mails, or written correspondence between the project office/grants management office and the principal investigator. Periodic site visits with officials of the grantee organization may also occur. The results of these monitoring activities will be recorded in the official grant file and will be available to the grantee upon request consistent with applicable disclosure statutes and with FDA disclosure regulations. Also, the grantee organization must comply with all special terms and conditions of the cooperative agreement, including those which state that future funding of the study will depend on recommendations from the project officer. The scope of the recommendation will confirm that: (1) There has been acceptable progress on the project; (2) there is continued compliance with all FDA regulatory requirements; (3) if necessary, there is an indication that corrective action has taken place; and (4) assurance that any replacement of personnel will meet the testing requirements. PO 00000 Frm 00047 Fmt 4703 Sfmt 4703 VII. Agency Contacts Regarding the administrative and financial management aspects of this notice: Michelle Caraffa (see Addresses to Request Application in section IV of this document). Regarding the programmatic or technical aspects of this notice: Alexandra Cossi, Division of Federal State Relations, Office of Regulatory Affairs, Food and Drug Administration (HFC–140), 5600 Fishers Lane, rm. 12– 07, Rockville, MD 20857, 301–827– 2899, e-mail: alexandra.cossi@fda.hhs.gov. VIII. Other Information Data included in the application, if restricted with the legend specified in this section of the document, may be entitled to confidential treatment as trade secret or confidential commercial information within the meaning of the Freedom of Information Act and FDA’s implementing regulations (21 CFR 20.61). Unless disclosure is required under the Freedom of Information Act as amended (5 U.S.C. 552), as determined by the freedom of information officials of the Department of Health and Human Services or by a court, data contained in the portions of this application that have been specifically identified by page number, paragraph, etc., by the applicant as containing restricted information, shall not be used or disclosed except for evaluation purposes. Dated: August 18, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 06–7124 Filed 8–21–06; 12:49 pm] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA 225–06–8403] Memorandum of Understanding Between the U.S. Food and Drug Administration, the National Cancer Institute, and the National Institute of Standards and Technology AGENCY: Food and Drug Administration, HHS. ACTION: Notice. SUMMARY: The purpose of this Memorandum of Understanding (MOU) is to set forth an agreement between the National Cancer Institute (NCI), the National Institute of Standards and Technology (NIST), and the Food and E:\FR\FM\24AUN1.SGM 24AUN1 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices VerDate Aug<31>2005 15:15 Aug 23, 2006 Jkt 208001 among the Parties will be focused primarily on the Nanotechnology Characterization Laboratory and directly related activities. DATES: The agreement became effective June 22, 2006. FOR FURTHER INFORMATION CONTACT: For FDA: Wendy R. Sanhai, Senior Scientific Advisor, Office of the Commissioner (HF–18), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–827– 7867, FAX: 301–443–9718. For NCI: Gregory J. Downing, Director, Office of Technology and Industrial Relations, Office of the Director, National Cancer Institute, 31 Center Dr., rm. 10A52, Bethesda, MD 20892, 301–496–1550, FAX: 301–496–7807. PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 For NIST: Debra Kaiser, Chief, Ceramics Division, Materials Science and Engineering Laboratory, National Institute of Standards and Technology, 100 Bureau Dr., Stop 8522, Gaithersburg, MD 20899, 301– 975–6119, FAX: 301–975–5334. In accordance with 21 CFR 20.108(c), which states that all written agreements and MOUs between FDA and others shall be published in the Federal Register, the agency is publishing notice of this MOU. SUPPLEMENTARY INFORMATION: Dated: August 16, 2006. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S E:\FR\FM\24AUN1.SGM 24AUN1 EN24AU06.025</GPH> rmajette on PROD1PC67 with NOTICES1 Drug Administration (FDA) (collectively ‘‘the Parties’’, or individually as a ‘‘Party’’) regarding the roles, responsibilities, and financial commitments of each Party relating to the collaboration through working groups and steering committees to develop strategic plans, set priorities, and leverage resources and expertise from multiple sources, including the private sector, toward the goal of facilitating the development of nanotechnologies that constitute novel research tools and safer, more effective cancer therapies by establishing a framework for effective risk identification, assessment and evaluation of emerging products based on nanotechnology. This collaboration 50073 VerDate Aug<31>2005 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices 15:15 Aug 23, 2006 Jkt 208001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4725 E:\FR\FM\24AUN1.SGM 24AUN1 EN24AU06.026</GPH> rmajette on PROD1PC67 with NOTICES1 50074 VerDate Aug<31>2005 15:15 Aug 23, 2006 Jkt 208001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\24AUN1.SGM 24AUN1 50075 EN24AU06.027</GPH> rmajette on PROD1PC67 with NOTICES1 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices VerDate Aug<31>2005 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices 15:15 Aug 23, 2006 Jkt 208001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4725 E:\FR\FM\24AUN1.SGM 24AUN1 EN24AU06.028</GPH> rmajette on PROD1PC67 with NOTICES1 50076 Federal Register / Vol. 71, No. 164 / Thursday, August 24, 2006 / Notices 50077 [FR Doc. 06–7127 Filed 8–23–06; 8:45 am] VerDate Aug<31>2005 15:15 Aug 23, 2006 Jkt 208001 PO 00000 Frm 00052 Fmt 4703 Sfmt 4703 E:\FR\FM\24AUN1.SGM 24AUN1 EN24AU06.029</GPH> rmajette on PROD1PC67 with NOTICES1 BILLING CODE 4160–01–C

Agencies

[Federal Register Volume 71, Number 164 (Thursday, August 24, 2006)]
[Notices]
[Pages 50072-50077]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 06-7127]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-06-8403]


Memorandum of Understanding Between the U.S. Food and Drug 
Administration, the National Cancer Institute, and the National 
Institute of Standards and Technology

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The purpose of this Memorandum of Understanding (MOU) is to 
set forth an agreement between the National Cancer Institute (NCI), the 
National Institute of Standards and Technology (NIST), and the Food and

[[Page 50073]]

Drug Administration (FDA) (collectively ``the Parties'', or 
individually as a ``Party'') regarding the roles, responsibilities, and 
financial commitments of each Party relating to the collaboration 
through working groups and steering committees to develop strategic 
plans, set priorities, and leverage resources and expertise from 
multiple sources, including the private sector, toward the goal of 
facilitating the development of nanotechnologies that constitute novel 
research tools and safer, more effective cancer therapies by 
establishing a framework for effective risk identification, assessment 
and evaluation of emerging products based on nanotechnology. This 
collaboration among the Parties will be focused primarily on the 
Nanotechnology Characterization Laboratory and directly related 
activities.

DATES: The agreement became effective June 22, 2006.

FOR FURTHER INFORMATION CONTACT:
For FDA: Wendy R. Sanhai, Senior Scientific Advisor, Office of the 
Commissioner (HF-18), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7867, FAX: 301-443-9718.
For NCI: Gregory J. Downing, Director, Office of Technology and 
Industrial Relations, Office of the Director, National Cancer 
Institute, 31 Center Dr., rm. 10A52, Bethesda, MD 20892, 301-496-1550, 
FAX: 301-496-7807.
For NIST: Debra Kaiser, Chief, Ceramics Division, Materials Science and 
Engineering Laboratory, National Institute of Standards and Technology, 
100 Bureau Dr., Stop 8522, Gaithersburg, MD 20899, 301-975-6119, FAX: 
301-975-5334.

SUPPLEMENTARY INFORMATION: In accordance with 21 CFR 20.108(c), which 
states that all written agreements and MOUs between FDA and others 
shall be published in the Federal Register, the agency is publishing 
notice of this MOU.

    Dated: August 16, 2006.
Jeffrey Shuren,
Assistant Commissioner for Policy.
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[FR Doc. 06-7127 Filed 8-23-06; 8:45 am]
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