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
NHANES IV will draw a large scientific sample of individuals of all ages from the U.S. population and give them a voluntary interview and physical examination to measure health and nutritional status. This will allow estimation of the prevalence of diseases, risk factors, and of baseline health and nutritional measures in the population.
On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
(i) Why the information is being collected;
(ii) Use of information;
(iii) Burden estimate;
(iv) Nature of response (voluntary, required for a benefit, or mandatory);
(v) Nature and extent of confidentiality; and
(vi) Need to display currently valid OMB control number;
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
Fourth National Health and Nutrition Examination Survey (NHANES IV)