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- DEPARTMENT OF HEALTH AND h JMAN SERVICES PROTECTION OF HUMAN SUBJECTS ORIGINAL a FOLLOWUP [7 EXEMPTION Human Subjects Experiments (Divers) with Air Tagged with Radioisotopes 1 3 N and 4 l A r 2. PRINCIPAL INVESTIGATOR, PROGRAM DIRECTOR, OR FELLOW 3. FOOD AND DRUG ADMINISTRATION REQUIRED INFORMATION (see reverse side) This institution has an approved assurance of compliance on file with HHS which covers this activity. 0No assurance of compliance which applies t o this activity has been established with HHS, but the applicant institution will provide written assurance 01 compliance and certification of IRE review and approval in accordance with 45 CFR 46 upon request. 5. CERTIFICATION OF IRE REVIEW OR DECLARATION OF EXEMPTION [?bThis activity has been reviewed and approved by an IRE in accordance with the requirements of 45 CFR 46, including i t s relevant Subparts. This certifi cation fulfills, when applicable, requirements for certifying FDA status for each investigational new drug or device. (See reverse side of this form.) --Date of IRE review and approval. (If approval is pending, write '@ending." Followup certification is required.) [XI Full Board Review 0This activity contains multiple projects, some of which have not been reviewed. The IRE has granted approval on condition that all projects covered b\ 45 CFR 46 will be reviewed and approved before they are initiated and that appropriate further certification fForm HHS 596) will be submitted. 0Human subjects are involved, but this activity qualifies for exemption under 46.101 (b) in accordance with paragraph of exemption in 46.707(61, 7 through 5). but the institution did not designate that exemption o n the application. 6. Each official signing below certifies that the information provided on this form i s correct and that each institution assumes responsibility for assuring required future reviews, approvals, and submissions of certification. APPLl CANT I NSTlTUTl ON II COOPERATING INSTITUTION NAME. ADDRESS, AND TELEPHONE NO. I[ NAME, ADDRESS, AND TELEPHONE NO. Lawrence Livermore National Laboratory 11II NAME AND TITLE OF OFFICIAL (print or type) NAME AND TITLE OF OFFICIAL (printortype)