Re: Docket Number 1980N – 0208
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چکیده
A second pathway for licensure of vaccines and drugs for bioterrorism, the so-called Animal Rule promulgated by FDA in 2002, requires data obtained from at least two animal species, in conjunction with correlates of immunity that assure the animal data can be extrapolated to humans with absolute reliability. No such correlates of immunity (i.e., surrogate markers for survival following exposure to anthrax) have yet been established
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Comprehensive Review of Licensing and Operating Rules for Satellite Services
prepared by the petitioner, Investigaciones y Aplicaciones Biotecnologicas S.L., Avda, Paret del Patriarca 11–B, Ap. 30, 46113 Moncada (Valencia) Spain, was available in the docket at http://www.regulations.gov. Through an administrative error, the summary of the pesticide petition was not made available in the docket. The Agency has made the summary of the pesticide petition (PP 3F8177) availa...
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and/or RIN in the subject line of the message. Submit electronic comments in Word Perfect, Microsoft Word, PDF, or ASCII file format, and avoid the use of special characters or any form on encryption. 3. Postal Mail: Ms. Brenda Edwards, U.S. Department of Energy, Building Technologies Office, Mailstop EE–5B, 1000 Independence Avenue SW., Washington, DC 20585–0121. If possible, please submit all...
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