The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)

The Food and Drug Administration Safety and Innovation Act (P.L. 112-144)

Date: August 21, 2012
Creator: Thaul, Susan; Bagalman, Erin; Corby-Edwards, Amalia K.; Glassgold, Judith M.; Johnson, Judith A.; Lister, Sarah A. et al.
Description: This report provides a brief policy background narrative and an overview of provisions for each title of the Food and Drug Administration Safety and Innovation Act (FDASIA), P.L. 112-144. The legislation amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to expand the authority of the Food and Drug Administration (FDA) in performing its human drug, biological product, and medical device responsibilities.
Contributing Partner: UNT Libraries Government Documents Department
Smallpox Vaccine Stockpile and Vaccination Policy

Smallpox Vaccine Stockpile and Vaccination Policy

Date: September 9, 2002
Creator: Johnson, Judith A
Description: None
Contributing Partner: UNT Libraries Government Documents Department
Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1985 Annual Report.

Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1985 Annual Report.

Date: June 1, 1986
Creator: Kaattari, Stephen L.
Description: Bacterial kidney disease (BRD) has been and remains a chronic contributory problem limiting the productivity of salmon in the Columbia River Basin. Control of this disease will not come easily, but it would lead to a tremendous increase in the health and numbers of salmon populations. Vaccination of salmon to Renibacterium salmoninarum (KDB) is a potentially successful method of controlling this disease. To date, however, no successful vaccine has been developed for general use. A possible solution to this problem, and thus the goal of this research, is to isolate the antigenic components of KDB and enhance their ability to activate the host defenses. This will be accomplished by the chemical modification of these antigens with potent immunomodulatory substances. These modified antigens will then be tested for their effectiveness in inducing immunity to BKD and thereby preventing the disease. The goal of the project's second year was to chemically modify the major antigens of Renibacteirium salmoninarum, immunize coho salmon (Oncorhynchus kisutch), and to test the immunogenicity of the preparations used. Immunogenicity of the antigenic material was tested by (1) admixture experiments, using whole KD cells with muramyl dipepetide, Vibrio anguillarum extract, E. coli lipopolysaccharide, or Mycobacterium tuberculosis in Freund's complete ...
Contributing Partner: UNT Libraries Government Documents Department
Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1986 Annual Report.

Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1986 Annual Report.

Date: June 1, 1987
Creator: Kaattari, Stephen L.
Description: Bacterial kidney disease (BRD) has been and remains a chronic contributory problem limiting the productivity of salmon of the Columbia River Basin. Control of this disease will not come easily, but it would lead to a tremendous increase in the health and numbers of salmon populations. Vaccination of salmon of Renibacterium salmoninarum (KDB) is a potentially successful method of controlling this disease. To date, however, no successful vaccine has been developed for general use. A possible solution to this problem,and thus the goal of this research, is to isolate the antigenic components of KDB and enhance their ability to activate the host defenses. This will be accomplished by the chemical modification of these antigens with potent immunomodulatory substances. These modified antigens will then be tested for their effectiveness in inducing immunity to BKD and thereby preventing the disease. The goal of the project's third year was to test the immunogenicity and prophylactic value in coho salmon (Oncorhynchus kisutch) of various chemical conjugates of Renibacterium salmoninarum cells and major antigens. This was accomplished by assessing the serum antibody response, the cellular immune response (cellular proliferation), and the kinetics of mortality after Lethal injections of the bacterium. An important facet of this ...
Contributing Partner: UNT Libraries Government Documents Department
Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1987 Annual Report.

Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1987 Annual Report.

Date: June 1, 1988
Creator: Kaattari, Stephen
Description: Bacterial kidney disease (BKD) has been and remains a chronic contributory problem limiting the productivity of salmon in the Columbia River Basin. Control of this disease will not come easily, but it would lead to a tremendous increase in the health and numbers of salmon populations. Vaccination of salmon to Renibacterium salmoninarum (KDB) is a potentially successful method of controlling this disease. To date, however, no successful vaccine has been developed for general use. A possible solution to this problem, and thus the goal of this research, is to isolate the antigenic components of KDB and enhance their ability to activate the host defenses. This will be accomplished by the chemical modification of these antigens with potent immunomodulatory substances. These modified antigens will then be tested for their effectiveness in inducing immunity to BKD and thereby preventing the disease. The goal of the project's fourth year was to test the immunogenicity and prophylactic value in coho salmon (Oncorhynchus kisutch) of various--chemical conjugates of Renibacterium salmoninarum cell and major antigens. This was accomplished by assessing the serum antibody response, the cellular immune response (chemiluminescence), and the kinetics of mortality after lethal injections of the bacteria. The studies completed this year have: ...
Contributing Partner: UNT Libraries Government Documents Department
Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1988 Final Report.

Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1988 Final Report.

Date: August 1, 1989
Creator: Kaattari, Stephen L.
Description: Bacterial kidney disease of salmonids is a very complex disease which appears to exploit a variety of pathogenic mechanisms. An understanding of these mechanisms is essential to the development of efficacious vaccines. It has become well established from the studies published .in this report and those of others that soluble antigens which are secreted by Renibacterium salmoninarum have toxigenic potential. If they are found to be responsible for mortality, the development of toxoid(s) could be paramount to the production of a vaccine. One must, however, be circumspect in producing a vaccine. A thorough knowledge, not only of the pathogen, but also of the immune system of the host is an absolute requirement. This becomes of particular importance when dealing with fish diseases, since the field of fish immunology is still within its infancy. This lack of knowledge is particularly felt when the induction of a prophylactic immune response concomitantly leads to pathological side effects which may be as destructive as the original infection. Indeed, it appears that some aspects of BKD may be due to the induction of hypersensitivity reactions. If such immunopathologies are expressed, it is prudent to thoroughly evaluate the nature of the immunoprophylaxis to insure that these ...
Contributing Partner: UNT Libraries Government Documents Department
Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1984 Annual Report.

Development of a Vaccine for Bacterial Kidney Disease in Salmon, 1984 Annual Report.

Date: June 1, 1985
Creator: Kaattari, Stephen L.
Description: The data presented here demonstrate that there is some variability to the antigenic structure of KDB. Although gel filtration of all antigenic preparations revealed a wide range of sizes for antigens, resolution on a denaturing gel revealed relatively few protein bands and immunological assays revealed the same (3) low number of antigens. It is of particular interest that there seems to be a protein of 60 kd in all preparations, but that there are not larger individual molecular species. This, in turn indicates that the larger molecular weight species detected in gel filtration are most likely aggregates or membrane fragments composed of a lower molecular weight subunit. Use of ultrafiltration of KDM-2 medium appears to be successful in eliminating contamination of high molecular weight material found in KDM-2. There appears to be no alteration in the number of soluble antigens produced by growth in either medium, nor in the number of proteins, as detected by SDS-PAGE. However, soluble antigens isolated from UF-KDM-2 does appear to have greater heterogeneity in their isoelectric focusing (IEF) patterns than those from UF-KDM-2. Also, although there does appear to be an extended lag period in KDB growth on UF-KDM-2, there is no alteration in final ...
Contributing Partner: UNT Libraries Government Documents Department
Biochemical and biophysical characterization of the major outer surface protein, OSP-A from North American and European isolates of Borrelia burgdorferi

Biochemical and biophysical characterization of the major outer surface protein, OSP-A from North American and European isolates of Borrelia burgdorferi

Date: December 31, 1995
Creator: McGrath, B.C.; Dunn, J.J.; France, L.L.; Jaing, W.; Polin, D.; Gorgone, G. et al.
Description: Lyme borreliosis, caused by the spirochete Borrelia burgdorferi, is the most common vector-borne disease in North America and Western Europe. As the major delayed immune response in humans, a better understanding of the major outer surface lipoproteins OspA and OspB are of much interest. These proteins have been shown to exhibit three distinct phylogenetic genotypes based on their DNA sequences. This paper describes the cloning of genomic DNA for each variant and amplification of PCR. DNA sequence data was used to derive computer driven phylogenetic analysis and deduced amino acid sequences. Overproduction of variant OspAs was carried out in E. coli using a T7-based expression system. Circular dichroism and fluorescence studies was carried out on the recombinant B31 PspA yielding evidence supporting a B31 protein containing 11% alpha-helix, 34% antiparallel beta-sheet, 12% parallel beta sheet.
Contributing Partner: UNT Libraries Government Documents Department
Modeling the effects of prior infection on vaccine efficacy

Modeling the effects of prior infection on vaccine efficacy

Date: November 1, 1997
Creator: Smith, D.J.; Forrest, S.; Ackley, D.H. & Perelson, A.S.
Description: We performed computer simulations to study the effects of prior infection on vaccine efficacy. We injected three antigens sequentially. The first antigen, designated the prior, represented a prior infection or vaccination. The second antigen, the vaccine, represented a single component of the trivalent influenza vaccine. The third antigen, the epidemic, represented challenge by an epidemic strain. For a fixed vaccine to epidemic strain cross-reactivities to the vaccine and to the epidemic strains. We found that, for many cross-reactivities, vaccination, when it had been preceded by a prior infection, provided more protection than vaccination alone. However, at some cross-reactivities, the prior infection reduced protection by clearing the vaccine before it had the chance to produce protective memory. The cross-reactivities between the prior, vaccine and epidemic strains played a major role in determining vaccine efficacy. This work has applications to understanding vaccination against viruses such as influenza that are continually mutating.
Contributing Partner: UNT Libraries Government Documents Department
Advanced Algorithms for Rapidly Reconstructing Clandestine Releases of Biological Agents in Urban Areas

Advanced Algorithms for Rapidly Reconstructing Clandestine Releases of Biological Agents in Urban Areas

Date: February 25, 2000
Creator: Shinn, J.H.; Hall, C.H.; Neher, L.A.; Wilder, F.J.; Gouveia, D.W.; Layton, D.W. et al.
Description: As the United States plays a greater role in the 21st Century as global peacekeeper and international defender of human rights and democratic principles, there is an increasing likelihood that it will become the focus of acts of terrorism. Such acts of terrorism--sometimes described as ''asymmetric''--could involve the threat or use of weapons of mass destruction (WMD), particularly those considered unconventional, which include ones designed to release chemical or biological agents. In fact, biological agents are of great concern because, as noted by D.A. Henderson of the Center for Civilian Biodefense Studies at Johns Hopkins University in Baltimore, MD, ''... with shortages of hospital space, vaccines, antibiotics, there would be chaos.'' (Williams, 2000). Unfortunately, potential aggressor nations, terrorist groups, and even individuals, can, for a modest cost and effort, develop covert capabilities for manufacturing, transporting, and offensively using biological weapons of mass destruction. Furthermore, there is evidence to indicate that terrorist increasingly are targeting civilian populations--in order to inflict indiscriminate casualties--as well as other more traditional targets such as symbolic buildings or organizations (see Tucker, 1999), which suggest that introducing rapid treatment after a biological event may be more practical than concentrating on prevention (see Siegrist, 1999), especially because sensors ...
Contributing Partner: UNT Libraries Government Documents Department
FIRST PREV 1 2 NEXT LAST