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)