Memorandum of Understanding Between the Food and Drug Administration, Center for Biologics Evaluation and Research, and the National Institutes of Health, National Institute of Neurological Disorders and Stroke, 54926-54942 [05-18514]

Download as PDF 54926 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices that it is seeking pharmaceutical companies to participate in a pilot program involving the submission of CMC information consistent with a new pharmaceutical quality assessment system. The Office of New Drug Chemistry (ONDC) in the Office of Pharmaceutical Science, Center for Drug Evaluation and Research, is establishing a modern, risk-based pharmaceutical quality assessment system, as described in a September 2004 White Paper, ‘‘ONDC’s New Risk-Based Pharmaceutical Quality Assessment System’’ (https://www.fda.gov/cder/gmp/ gmp2004/ondc_reorg.htm). The pilot program will provide additional information for ONDC to use in implementing the new quality assessment system. The pilot program will provide participating pharmaceutical companies an opportunity to submit critical CMC information that demonstrates their understanding of quality by design, product knowledge, and process understanding of the drug substance and drug product at the time of submission of an NDA. The pilot program will also enable the public and regulated industry to provide feedback that will assist FDA in developing guidance for industry on the new quality assessment system. The July 14, 2005 (70 FR 40719), notice provided deadlines related to the submission of certain information related to the pilot program. To ensure inclusive and relevant results from the pilot program, this notice extends the deadlines as follows: Requests to participate in the pilot program to March 31, 2006, from October 31, 2005, and submission of eligible New Drug Applications (NDA) to March 31, 2007, from December 31, 2006. This notice also extends the comment period on the pilot program to March 31, 2007, from December 31, 2006. See the process VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 section (II.B) in the July 14, 2005 (70 FR 40719) notice for instructions on submitting requests to participate in the pilot program. All requests to participate in the pilot program, both written and electronic, should be marked confidential. II. Comments Interested persons may submit written comments on this pilot program to the Division of Dockets Management (see ADDRESSES). Two copies of any comments 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. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday. While detailed information on participating NDAs will not be publicly available, names of participating applicants will be made public. Dated: September 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. [FR Doc. 05–18515 Filed 9–16–05; 8:45 am] BILLING CODE 4160–01–S DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Memorandum of Understanding Between the Food and Drug Administration, Center for Biologics Evaluation and Research, and the National Institutes of Health, National Institute of Neurological Disorders and Stroke Food and Drug Administration, HHS. PO 00000 Frm 00035 Notice. SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between the Food and Drug Administration, Center for Biologics Evaluation and Research (FDA/CBER), and the National Institutes of Health, National Institute of Neurological Disorders and Stroke (NIH/ NINDS). The purpose of this MOU is to provide a framework for coordination and collaborative efforts between these two entities, which are both components of the Department of Health and Human Services. This MOU also provides the principles and procedures by which information sharing between FDA/CBER and NIH/NINDS units shall take place. The agreement became effective February 12, 2002. DATES: For FDA/CBER: Kimberly Benton, Center for Biologics Evaluation and Research, Food and Drug Administration, 1401 Rockville Pike, WOC1/rm. 209N, Rockville, MD 20852, 301–827–5102. For NIH/NINDS: Robert Finkelstein, Extramural Research, Neuroscience Center, National Institutes of Health, 6001 Executive Blvd., rm. 2143, Bethesda, MD 20892, 301–496–9248. FOR FURTHER INFORMATION CONTACT: 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: [FDA 225–02–1000] AGENCY: ACTION: Dated: September 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S Fmt 4703 Sfmt 4703 E:\FR\FM\19SEN1.SGM 19SEN1 VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00036 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 54927 En19se05.003</GPH> Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices VerDate Aug<31>2005 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 En19se05.004</GPH> 54928 VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00038 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 54929 En19se05.005</GPH> Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices VerDate Aug<31>2005 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00039 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 En19se05.006</GPH> 54930 VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00040 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 54931 En19se05.007</GPH> Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices VerDate Aug<31>2005 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00041 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 En19se05.008</GPH> 54932 VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 54933 En19se05.009</GPH> Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices VerDate Aug<31>2005 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00043 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 En19se05.010</GPH> 54934 VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00044 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 54935 En19se05.011</GPH> Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices VerDate Aug<31>2005 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00045 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 En19se05.012</GPH> 54936 VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00046 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 54937 En19se05.013</GPH> Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices VerDate Aug<31>2005 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00047 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 En19se05.014</GPH> 54938 VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00048 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 54939 En19se05.015</GPH> Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices VerDate Aug<31>2005 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00049 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 En19se05.016</GPH> 54940 VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00050 Fmt 4703 Sfmt 4725 E:\FR\FM\19SEN1.SGM 19SEN1 54941 En19se05.017</GPH> Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices 54942 Federal Register / Vol. 70, No. 180 / Monday, September 19, 2005 / Notices ACTION: BILLING CODE 4160–01–C SUMMARY: The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the Veterans Health Administration (VHA). The purpose of this MOU is to extend an existing formal collaboration between FDA and VHA for the purpose of developing and implementing terminology standards for medication information. DATES: The agreement became effective June 28, 2005. FOR FURTHER INFORMATION CONTACT: Randy Levin, Health and Regulatory DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [FDA 225–05–3000] Memorandum of Understanding Between the Food and Drug Administration and the Veterans Health Administration AGENCY: Food and Drug Administration, HHS. VerDate Aug<31>2005 15:48 Sep 16, 2005 Jkt 205001 PO 00000 Frm 00051 Fmt 4703 Sfmt 4703 Data Standards (HFD–001), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301–594– 5411. 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: September 8, 2005. Jeffrey Shuren, Assistant Commissioner for Policy. BILLING CODE 4160–01–S E:\FR\FM\19SEN1.SGM 19SEN1 En19se05.018</GPH> Notice. [FR Doc. 05–18514 Filed 9–16–05; 8:45 am]

Agencies

[Federal Register Volume 70, Number 180 (Monday, September 19, 2005)]
[Notices]
[Pages 54926-54942]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-18514]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[FDA 225-02-1000]


Memorandum of Understanding Between the Food and Drug 
Administration, Center for Biologics Evaluation and Research, and the 
National Institutes of Health, National Institute of Neurological 
Disorders and Stroke

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) is providing notice of 
a memorandum of understanding (MOU) between the Food and Drug 
Administration, Center for Biologics Evaluation and Research (FDA/
CBER), and the National Institutes of Health, National Institute of 
Neurological Disorders and Stroke (NIH/NINDS). The purpose of this MOU 
is to provide a framework for coordination and collaborative efforts 
between these two entities, which are both components of the Department 
of Health and Human Services. This MOU also provides the principles and 
procedures by which information sharing between FDA/CBER and NIH/NINDS 
units shall take place.

DATES: The agreement became effective February 12, 2002.

FOR FURTHER INFORMATION CONTACT: For FDA/CBER: Kimberly Benton, Center 
for Biologics Evaluation and Research, Food and Drug Administration, 
1401 Rockville Pike, WOC1/rm. 209N, Rockville, MD 20852, 301-827-5102.
    For NIH/NINDS: Robert Finkelstein, Extramural Research, 
Neuroscience Center, National Institutes of Health, 6001 Executive 
Blvd., rm. 2143, Bethesda, MD 20892, 301-496-9248.

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: September 8, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
BILLING CODE 4160-01-S

[[Page 54927]]

[GRAPHIC] [TIFF OMITTED] TN19SE05.003


[[Page 54928]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.004


[[Page 54929]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.005


[[Page 54930]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.006


[[Page 54931]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.007


[[Page 54932]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.008


[[Page 54933]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.009


[[Page 54934]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.010


[[Page 54935]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.011


[[Page 54936]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.012


[[Page 54937]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.013


[[Page 54938]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.014


[[Page 54939]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.015


[[Page 54940]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.016


[[Page 54941]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.017


[[Page 54942]]


[GRAPHIC] [TIFF OMITTED] TN19SE05.018

[FR Doc. 05-18514 Filed 9-16-05; 8:45 am]
BILLING CODE 4160-01-C
This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.