General Advisory Committee

Whitman s career in the post-war period was highly significant. At M.I.T. he directed the first study, in 1948, of the use of nuclear power for airplanes. On leave from M.I.T., he was on the General Advisory Committee of the Atomic Energy Commission and, successively. Chairman of the Research and Development Board of the Joint Chiefs of Staff of the Department of Defense, organized under United Nations auspices of the First International Conference on the Peaceful Uses of Atomic Energy, and Science Advisor to the Department of State. 

Lewis L. Strauss, Men and Decisions (Garden City, N.Y. Doubleday and Co., 1962), pp. 1-230 Hewlett and Duncan, Atomic Shield, pp. 130-131, 380-409 Warren Unna, "Dissension in the AEC," Atlantic Monthly, May 1957, pp. 36-41. The 1946 law established the General Advisory Committee, composed of nine civilian members appointed by the president to give assistance to tt e agency on scientific and technical matters. The GAC significantly influenced Commission policy down to the 1960s. 

WUson Office Files, AEC/DOE AEC press release, 4 May 1962, AEC/NRC Appendix 7, "Information and Assistance from Organizations and Sources External to the Commission," Appendix 8, "Recommendations on Central Station Power Reactors by the General Advisory Committee," Appendix 1, "Fossil Fuel Resources of the United States," Appendix 3, "Overall Growth of Energy Requirements," in "Civilian Nuclear Power, Appendices to a Report to the President," printed in JCAE, committee print. Nuclear Power Economics—1962 through 1967, 90th Cong., 2d sess., 1968, pp. 244-246, 248-250, 171-199, 214-218. 

Beall, S. E. et al.. Status and Objectives—Homogeneous Reactor Project Summaries of Presentations to the Reactor Sub-committee of the General Advisory Committee. US.VEC - Report CF-56-l-26(l)el.), Oak Ridge National Laboratory,, Ian. 10, 1956. 

Other offices within ODER may become involved in the review process via consults. Eor example, the Office of Epidemiology and Biostatistics analyzes statistical data, the Office of Research Resources provides bioavailabiHty reviews, and the Office of Compliance determines from the results of inspections whether the firms meet EDA s Current Good Manufacturing Practice (cGMP) regulations. Advisory committees composed of independent experts are often asked to meet and further analyze the data. Often they also advise as to what additional data and information may be needed. After PDA s review is completed, PDA issues either a Summary Basis of Approval (SBA) for the dmg or a recommendation against approval. If approved, PDA releases the SBA and a summary of the safety and effectiveness data to the general pubHc. 

Vaccines are used in either the general population of children or adults or for special groups. Recommendations for vaccine usage are made by the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control. The Committee on Infectious Diseases of the American Academy of Pediatrics (Redbook Committee) also makes recommendations for infants through adolescents, and the American Academy of Family Physicians makes recommendations for adults. An excellent review of vaccine history, development, usage, and related regulatory issues is available (2). 

Smoking and Health Report of the Advisory Committee to the Surgeon General ofthe PubhcHealth Service, PHS publication 1103, p. 53. 

Figure 4.12 The CDER review process for a typical NDA. In addition to the review stages described, the FDA may also consult with a technical advisory committee. The members of the advisory committee are not routinely involved in IND or NDA assessment. The FDA is not obliged to follow any advice given by the advisory committee, but it generally does so...

My first eneonnter with Professor Hitoshi Ohtaki was made in 2002 during the 7th EnAs C S held in Karaehi, Pakistan. He has extended me an offer to become a member of the International Advisory Committee of EuAs C S. Since 2004,1 had closely worked with him for the preparation of the 9th Eurasia Conference, he was the Permanent General Coordinator of the International Organizing Committee of EuAs C S. 

In the development of most new active substances, it is required to investigate the disposition of the compound and its metabolite(s) and their rates and routes of elimination. This is generally carried out with radiolabelled compound, usually In the United Kingdom, approval of the Administration of Radioactive Substances Advisory Committee (ARSAC) is required for administration of radiolabelled compound to man. The purpose of the submission is to demonstrate that the dose of absorbed radiation is minimised by administration of the lowest dose that is consistent with meeting the objectives of the study. In general, the estimated absorbed radiation dose should be less than 500 xSv, but higher amoimts are permissible if they can be justified. The estimate is based on tissue distribution of radioactivity in animals and the pharmacokinetics in animals and man. 

Calcium has earned a reputation as one of the most at-risk nutrients (Foote et ah, 2004) and in 2005 the Dietary Guidelines Advisory Committee classified Ca as a shortfall nutrient because average Ca intake often falls to <60% of the recommended intake in subsets of the population (Kennedy and Meyers, 2005). The pressing need to improve the Ca status of Americans has been highlighted by the Healthy People 2010 Objective, an initiative that endeavors to increase, to at least 75%, the number of US individuals 2 years or older that meet current Ca recommendations (Looker, 2003). The general population requires ongoing education to more fully appreciate the relevance of Ca in relation to current and future health, the imminent risks associated with habitual inadequate intakes, and practical means by which to achieve recommended intakes. 

General recommendations on immunization. Recommendations of the Advisory Committee on Immunization Practices (ACIP). MMWR Morb Mortal Wkly Rep 2006 55(RR-15) 1. 

Some considerations would be if it s a drug that has significant questions, if it s the first in its class, or the first for a given indication, says Mark Goldberger, M.D., director of one of CDER s drug review offices. Generally, FDA takes the advice of advisory committees, but not always, he says. Their role is just that—to advise. ... 

IN GENERAL. After providing notice in the form of a letter and an opportunity for written response and a meeting, which may include an advisory committee meeting, the Secretary may (by order in the form of a letter) require the holder of an approved application for a drug under section 505 or the holder of a license for a biological product under section 351 of the Public Health Service Act (42 U. S.C. 262) to submit by a specified date the assessments described in subsection (a)(2) if the Secretary finds that... 

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