This collection
is approved on the following conditions: FDA shall provide a clear
justification for selecting four open facilities and conducting the
survey with the first two open facilities that agree to complete
the survey. The justification should explain in detail how this
approach does not introduce any bias into the sample. After
discussions with FDA, OMB will determine whether the controls
should be chosen as proposed or whether FDA should only select two
open facilities and take any additional measures necessary to
ensure sufficient response rates. FDA shall amend the package
accordingly with an addendum submitted to OMB for the public
file.
Inventory as of this Action
Requested
Previously Approved
09/30/2001
09/30/2001
648
0
0
183
0
0
0
0
0
This survey is intended to determine
reasons for facility closures, including those related to specific
MQSA regulations and those attributable to general operational
challenges. This survey will also gather information from
facilities continuing to provide mammography services to determine
the impact of MQSA regulations. A total of 460 facilities no longer
providing mammography services and 920 facilities continuing to
provide services will be given the opportunity to participate in a
15-minute telephone interview.
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.