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.
$5,360,000
No
No
No
No
No
Uncollected
Daniel Gitteson 3017965156 daniel.gitteson@fda.hhs.gov
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:
(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