Prior to
publication of the final rule, the agency should provide to OMB a
summary of all comments received on the proposed information
collection and identify any changes made in response to these
comments.
Inventory as of this Action
Requested
Previously Approved
09/30/2019
36 Months From Approved
10/31/2019
35,208,523
0
35,208,523
3,940,842
0
3,940,842
24,410,106
0
24,410,106
Under the regulations, as a first step
in becoming certified, mammography facilities must become
accredited by an FDA approved accreditation body (AB). This
requires undergoing a review of their clinical images and providing
the AB with information showing that they meet the equipment,
personnel, quality assurance and quality control standards, and
have a medical reporting and recordkeeping program, a medical
outcomes audit program, and a consumer compliant mechanism. On the
basis of this accreditation, facilities are then certified by FDA
or an FDA-approved State certification agency and must prominently
display their certificate. These actions are taken to ensure safe,
accurate, and reliable mammography on a nationwide basis.
In its proposed rule
“Mammography Quality Standards Act; Amendments to Part 900
Regulations” (84 FR 11669) FDA is proposing to amend its
mammography reporting requirements. The proposed revisions to the
third-party disclosure burden described in section 12a of this ICR,
would result in an increase of 1,347,744 hours to the estimated
burden.
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.