Pursuant to the
Paperwork Reduction Act, OMB has disapproved the Infan Feeding
Practices Study for the following reason: The use of a
self-selected "consumer panel" for a Federal survey violates the
guidelines contained in the Paperwork Rule, specifically paragraph
(g) of 5 CFR 1320.6. This method of sample selection has some
limited use in certain kinds of marketing research, but is not
acceptable for any study that may affect government policy. This
method does not satisfy the fundamental assumptions on which the
theory of statistical inference is based -- thus there is no sound
basis for generalizing the results from such a sample to the
universe of study as required by the rule. OMB, however, recognizes
the importance of gathering information on infant feeding
practices. It seems particularly important to have a better
understanding of these practices for disadvantaged populations.
Consequently, OMB encourages FDA to reassess alternative research
methodologies that would more adequately represent these
populations and other underrepresented groups in the currently
proposed survey, thus enabling the survey to be generalizable to
the entire population.
Inventory as of this Action
Requested
Previously Approved
06/30/1988
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A SAMPLE OF WOMEN WILL BE FOLLOWED BY
MAIL QUESTIONNAIRE FROM LATE PREGNANCY THROUGH THE BABY'S FIRST
YEAR TO PROVIDE DATA FOR DESCRIBING INFANT FEEDING PATTERNS, HEALTH
PROMOTION ACTIVITIES, AND MARKET RELATED BEHAVIORS. THE INFORMATION
WILL BE USED TO MEET FDA'S COMMITMENTS IN THE FEEDING SAFETY AND
HEALTH PROMOTION OF INFANTS.
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.