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0920-0237 199803-0920-005
Historical Active 199106-0920-005
HHS/CDC
Fourth National Health and Nutrition Examination Survey (NHANES IV)
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 06/05/1998
Retrieve Notice of Action (NOA) 03/30/1998
The pilot for NHANES IV, with the exception of the genetic component and as amended pursuant to the new Directive 15, is approved for use through 2/99. The next OMB submission covering the dress rehearsal and full fielding must include the following: 1) amendment to the household roster to identify relationships of all members to all other members as accomplished in the SIPP, CPS, SPD, and NHIS; 2) revised genetic consent forms and supporting materials. NCHS must continue to work with the relevant scientific experts affiliated with the National Human Genome Institute and implement recommendations from the National Bioethics Advisory Commission Report on Human Biological Materials. In addition, EXOP encourages NCHS to work with other Department experts to develop a consistent Department-wide policy governing genetic sampling and consent. In developing a new consent form and supporting materials, NCHS must consider the following options: a) refinement of the consent to allow different responses by category of research, e.g. as presented in the National Action Plan on Breast Cancer; b) the opportunity for respondents to opt out of any follow-up contacts based on genetic results; c) recontact of minors for consent when they reach majority age; d) revision of the Q's and A's to better articulate NCHS' safeguards and privacy policies, including descriptions of the nature of sample identification and the fact that donor names will not be disseminated beyond the immediate research team unless encoded; e) supporting materials that clarify who will make the decision whether to contact an individual with genetic test results and counseling, i.e. the Scientific Review Board and then the IRB; and f) a plan for field testing the new genetic consent materials prior to the full fielding of NHANES IV; 3) crosswalks between NHANES IV and relevant Federal surveys, i.e. the Continuing Survey of Food Intakes by Individuals, the Nationwide Food Consumption Survey, the CDC Nutrition Surveillance Program, and the FDA Total Diet Study and consideration of new opportunities for coordination with other Federal agencies such as the Census Bureau; and 4) for discussion purposes, a proposal for focusing and enhancing the effectiveness of OMB's ongoing review of the annual NHANES.
  Inventory as of this Action Requested Previously Approved
02/28/1999 02/28/1999
23,051 0 0
42,411 0 0
0 0 0