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.
After a review under the PRA,
we have determined that it is more appropriate to categorize
several of the information collections as third-party disclosure
because respondents send information to third-parties such as
accreditation bodies, facilities, patients, or physicians, rather
than directly to FDA. We have therefore moved these ICs to a newly
added third-party disclosure burden table above. To increase the
ease with which one may cross-reference the burden table items with
the narrative descriptions of the requirements, we have re-ordered
the descriptions in section 1 of this supporting statement to
appear by 21 CFR citation, rather than by IC burden type. The hour
burden tables have been corrected to reflect that the information
collected under 21 CFR 900.23 (evaluation of certification agency)
is maintained by the certification agency for FDA's annual
evaluation, but not sent to FDA and is, therefore, a recordkeeping
burden rather than a reporting burden. The figures in the "Total
Hours" column in all three burden tables have been rounded. (Where
the number was a portion of one hour, it has been rounded to 1
hour. All other numbers have been rounded to the nearest whole
number.) FDA previously estimated the annual burden for reporting
and recordkeeping requirements under information collection
0910-0309 to be 3,858,703 hours. The current total burden estimate
is 3,940,842 hours; an increase of 82,139 total burden hours. The
annualized cost burden estimate formerly associated with these
requirements was $58,598,274. The updated estimate is $64,168,727;
an increase of $5,570,453. The total capital cost listed in the
previous extension as $65,000, was incorrect due to a mathematical
or typographical error. Additionally, in error the $65,000 was
mistakenly left out of the ROCIS system. We have corrected the
total capital cost to read $68,000 and added it to the total
Capital and O&M costs in ROCIS. The capital costs have not
changed since the previous approval. The total operating and
maintenance cost formerly associated with these requirements was
$19,768,411. The updated estimate of operating and maintenance
costs is $24,410,106; an increase of $4,641,695. A number of
factors contributed to the adjustment of the number of hours and
monetary costs in the current estimates. The most significant
factors are: Change in the number of mammography facilities, which
resulted in adjustments to the number of respondents and a decrease
of annual responses by 183,081. The number of mammography
examinations has increased and is projected to be 40,000,000 per
year, an increase of 1,000,000 from the previous estimate. The cost
of materials and postage for mailing lay summaries has increased.
Personnel salaries have increased.
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.
Form FDA 3422 Mammography Facilities, Standards, and Lay Summaries for Patients
0309--MSQA Requirements--supporting statement.doc
Mammography Facilities, Standards, and Lay Summaries for Patients