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Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.
Please note that the OMB number and expiration date may not have been determined when this Information Collection Request and associated Information Collection forms were submitted to OMB. The approved OMB number and expiration date may be found by clicking on the Notice of Action link below.
View ICR - OIRA Conclusion
OMB Control No:
0920-0237
ICR Reference No:
199803-0920-005
Status:
Historical Active
Previous ICR Reference No:
199106-0920-005
Agency/Subagency:
HHS/CDC
Agency Tracking No:
Title:
Fourth National Health and Nutrition Examination Survey (NHANES IV)
Type of Information Collection:
Reinstatement with change of a previously approved collection
Common Form ICR:
No
Type of Review Request:
Regular
OIRA Conclusion Action:
Approved without change
Conclusion Date:
06/05/1998
Retrieve Notice of Action (NOA)
Date Received in OIRA:
03/30/1998
Terms of Clearance:
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
Expiration Date
02/28/1999
02/28/1999
Responses
23,051
0
0
Time Burden (Hours)
42,411
0
0
Cost Burden (Dollars)
0
0
0
Abstract:
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.
Authorizing Statute(s):
None
Citations for New Statutory Requirements:
None
Associated Rulemaking Information
RIN:
Stage of Rulemaking:
Federal Register Citation:
Date:
Federal Register Notices & Comments
Did the Agency receive public comments on this ICR?
No
Number of Information Collection (IC) in this ICR:
1
IC Title
Form No.
Form Name
Fourth National Health and Nutrition Examination Survey (NHANES IV)
ICR Summary of Burden
Total Approved
Previously Approved
Change Due to New Statute
Change Due to Agency Discretion
Change Due to Adjustment in Estimate
Change Due to Potential Violation of the PRA
Annual Number of Responses
23,051
0
0
23,051
0
0
Annual Time Burden (Hours)
42,411
0
0
42,411
0
0
Annual Cost Burden (Dollars)
0
0
0
0
0
0
Burden increases because of Program Change due to Agency Discretion:
Yes
Burden Increase Due to:
Burden decreases because of Program Change due to Agency Discretion:
No
Burden Reduction Due to:
Short Statement:
Annual Cost to Federal Government:
$0
Does this IC contain surveys, censuses, or employ statistical methods?
Yes
Part B of Supporting Statement
Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002?
No
Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]?
Uncollected
Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]?
Uncollected
Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)?
Uncollected
Is this ICR related to the Pandemic Response?
Uncollected
Common Form ICR:
No
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:
(a) It is necessary for the proper performance of agency functions;
(b) It avoids unnecessary duplication;
(c) It reduces burden on small entities;
(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;
(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;
(f) It indicates the retention periods for recordkeeping requirements;
(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:
(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;
(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.
(i) It uses effective and efficient statistical survey methodology (if applicable); and
(j) It makes appropriate use of information technology.
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.
Certification Date:
03/30/1998