Ss- 0910-0309

Supporting Statement – OMB No. 0910-0309

SUPPORTING STATEMENT
FOR
MAMMOGRAPHY QUALITY STANDARDS ACT REQUIREMENTS
21 CFR PART 900
OMB No. 0910-0309

A. JUSTIFICATION

1. Circumstances Necessitating Information Collection

The Food and Drug Administration (FDA) is requesting approval from the Office of Management and Budget (OMB) for the extension of the information collection requirements contained in the final regulations for mammography facilities as amended. These requirements are implemented under 21 CFR Part 900 (Attachment A). In addition to the request for extension, this supporting statement now serves to consolidate the previously approved information collection statement OMB No. 0910-0580 into 0910-0309.

These regulations are necessary to implement the Mammography Quality Standards Act of 1992 (MQSA) (42 U.S.C. 263b) (Attachment B) as amended by the Mammography Quality Standards Reauthorization Acts (MQSRA) of 1998 and 2004. The MQSA requires the establishment of a Federal certification and inspection program for mammography facilities; regulations and standards for accreditation and certification bodies for mammography facilities, and standards for mammography equipment, personnel, and practices, including quality assurance. MQSRA extended the life of the MQSA program until 2007 and also modified some of its original provisions. The intent of these regulations is to assure safe, reliable, and accurate mammography on a nationwide level.

Under the regulations, as a first step in becoming certified, mammography facilities must become accredited by a FDA approved accreditation body. This requires undergoing a review of their clinical images and providing the accreditation body 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.

Title 21 CFR Part 900 Mammography (Attachment A), as amended, requires:

21 CFR 900.3(b)(1) - Reporting
Private, non-profit organizations or State agencies are required to inform FDA of their intent to become an accreditation body.

21 CFR 900.3(b)(3) - Reporting

Private, non-profit organizations or State agencies are required to submit three copies of an application for approval as an accreditation body. This requirement is subdivided into full and limited applications.

21 CFR 900.3(c) - Reporting

An approved accreditation body must apply for renewal of approval or notify FDA of its plans not to apply for renewal of approval at least nine months before the expiration date of a body’s approval.

21 CFR 900.3(d)(2) – Reporting

Applicants are required to rectify application deficiencies within a specified timeframe.

21 CFR 900.3(d)(5) – Reporting

Denied applications may be resubmitted.

21 CFR 900.3(e) -Reporting

An accreditation body that decides to relinquish its accreditation authority before expiration of the body’s term of approval shall submit a letter of such intent to FDA at least nine months before relinquishing such authority.

21 CFR 900.3(f)(2) - Reporting

An accreditation body that does not apply for renewal of accreditation, is denied such approval by FDA, or relinquishes its accreditation authority shall notify all facilities accredited or seeking accreditation by the body that the body will no longer have accreditation authority.

21 CFR 900.4(c) - Reporting

The accreditation body shall review clinical images from each facility accredited by the body at least once every three years. This requirement is subdivided into accreditation body and facility burdens.

21 CFR 900.4(d) – Reporting

The accreditation body shall review phantom images from each facility accredited by the body at least once every three years. This requirement is subdivided into accreditation body and facility burdens.

21 CFR 900.4(e) – Reporting

Every facility applying for accreditation is required to submit with its initial accreditation application a mammography equipment evaluation. All facilities must undergo an annual survey to assure continued compliance with accreditation standards and to provide continued oversight of facilities quality control programs as they relate to standards. Accreditation bodies must review these records annually. This requirement is subdivided into accreditation body and facility burdens.

21 CFR 900.4(f) -Reporting

The accreditation body shall conduct onsite visits and random clinical image reviews of a sample of facilities to monitor and assess their compliance with standards established by the body for accreditation. The accreditation body shall submit annually to the FDA three copies of a summary report describing all facility assessments the body conducted under the provisions of this section for the year being reported.

21 CFR 900.4(h) - Reporting

The accreditation body is required to submit to FDA the information required by 42 U.S.C. 263b(d) for each facility when the facility is initially accredited and at least annually when updated. The accreditation body is required to notify FDA of applications containing information required by 42 U.S.C. 263b(c)(2) for provisional certificates and in 21 CFR 900.12(b)(2) for extension of provisional certificates. The accreditation body is required to submit to FDA the name, identifying information, and other information for any facility for which the accreditation body denies, suspends, or revokes accreditation. The accreditation body is required to submit to FDA an annual report summarizing all serious complaints received during the previous calendar year, their resolution status, and any actions taken in response to them. The accreditation body is required to provide to FDA any other information relevant to 42 U.S.C. 263b and required by FDA about any facility accredited or undergoing accreditation by the body. This requirement is subdivided into accreditation body and facility burdens.

21 CFR 900.4(i)(2) - Reporting

At FDA's request, accreditation bodies are required to submit financial records or other material to assist FDA in assessing the reasonableness of accreditation body fees.

21 CFR 900.6(c)(1) - Reporting

A former accreditation body that has had its approval withdrawn may submit a new application for approval if the body can provide information to FDA to establish that the problems that were grounds for withdrawal of approval have been resolved.

21 CFR 900.11(b)(1) – Reporting

A facility must apply to a FDA-approved accreditation body or to another entity as designated by FDA to qualify for a certificate for the lawful operation of a mammography facility.

21 CFR 900.11(b)(2) - Reporting

New facilities beginning operation after October 1, 1994 are eligible to apply for provisional certificates.

21 CFR 900.11(b)(3) - Reporting

A facility may apply for a 90-day extension to a provisional certificate.

21 CFR 900.11(c) – Reporting

A previously certified facility that has allowed its certificate to expire, that has been refused a renewal of its certificate by FDA, or that has had its certificate revoked by FDA, may apply to have the certificate reinstated.

21 CFR 900.12(c)(1) - Reporting

Each facility shall ensure that the medical report of the examination contains specific identifying information and content.

21 CFR 900.12(c)(2) - Reporting

Each facility shall maintain a system to ensure that a lay summary of his or her examination is provided to each patient and that the medical report of the examination is provided to the referring physician or, in the absence of a referring physician, to the patient. These summaries and reports are to be provided within 30 days of the examination but in cases where the assessments are “suspicious” or “highly suggestive of malignancy”, they are to be provided as soon as possible. In cases where the patient does not want to receive a lay summary, the facility can satisfy the requirement through alternative means. The requirement is subdivided to address both scenarios.

21 CFR 900.12(c)(3) - Reporting

Each facility shall maintain a system to ensure that the medical report of the examination is provided to the referring physician. These reports are to be provided within 30 days of the examination but in cases where the assessments are “suspicious” or “highly suggestive of malignancy”, they are to be provided as soon as possible.

21 CFR 900.12(h)(4) – Reporting

Facilities must report unresolved serious complaints to their accreditation body.

21 CFR 900.12(j)(1) - Reporting

If FDA believes that mammography quality at a facility has been compromised and may present a serious risk to human health, the facility shall provide clinical images and other relevant information for review by the accreditation body or other entity designated by FDA. This requirement is subdivided into accreditation body and facility burdens.

21 CFR 900.12(j)(2) - Reporting

If FDA determines that any activity related to the provision of mammography at a facility may present a serious risk to human health such that patient notification is necessary, the facility shall notify patients or their designees, their physicians, or the public of action that may be taken to minimize the effects of the risk.

21 CFR 900.15(c) -Reporting

A facility that has been denied accreditation by an accreditation body may request reconsideration of that adverse decision by the accreditation body.

21 CFR 900.15(d)(3)(ii) - Reporting

A facility that has been denied accreditation following appeal to the accreditation body may request reconsideration of that adverse decision by FDA.

21 CFR 900.18(c) - Reporting

Mammography facilities, accreditation bodies, State governments that are not accreditation bodies, and manufacturers and assemblers of equipment used for mammography may apply for approval of an alternative standard or for an amendment or extension of the alternative standard by submitting an application to FDA.

21 CFR 900.18(e) - Reporting

An application for amending or extending approval of an alternative standard must provide an explanation supported by data of how such an amendment or extension would assure equal or greater quality of production, processing, or interpretation of mammograms than the original standard.

21 CFR 900.21(b) - Reporting

An applicant seeking FDA approval as a certification agency must submit an application to FDA.

21 CFR 900.21(c)(2) - Reporting

If FDA notifies the applicant of any deficiencies in the application, the applicant must correct the deficiencies or FDA may deny the application.

21 CFR 900.22(h) - Reporting

A certification agency shall ensure timely and accurate electronic transmission of inspection and certification data to FDA.

21 CFR 900.22(i) - Reporting

A certification agency shall obtain FDA authorization for any changes it proposes to make in any standards that FDA has previously accepted.

21 CFR 900.23 - Reporting

FDA will perform an annual evaluation of each certification agency. The certification agency must correct any major deficiencies noted by FDA or FDA may withdraw approval of the certification agency.

21 CFR 900.24(a) - Reporting

A certification agency that is required to correct major deficiencies shall notify all facilities certified or seeking certification by it within a time period and in a manner approved by FDA.

21 CFR 900.24(a)(2) - Reporting

A certification agency that has lost its approval shall notify facilities certified or seeking certification by it as well as the appropriate accreditation bodies with jurisdiction in the State that its approval has been withdrawn. Such notification shall be made within a time frame and in a manner approved by FDA.

21 CFR 900.24(b) - Reporting

If FDA notifies a certification agency that there are certain minor deficiencies in its program, the certification agency must correct those deficiencies or FDA may withdraw its approval.

21 CFR 900.24(b)(1)

If FDA places a certification agency on probationary status, the certification agency shall notify all facilities certified or seeking certification by it of its probationary status within a time and in a manner approved by FDA

21 CFR 900.24(b)(3) - Reporting

If FDA determines that a certification agency that has been placed on probationary status is not implementing corrective actions satisfactorily or within the established schedule, FDA may withdraw approval of the certification agency. The certification agency shall notify all facilities certified or seeking certification by it, as well as the appropriate accreditation bodies with jurisdiction in the State, of its loss of FDA approval, within a time frame and in a manner approved by FDA.

21 CFR 900.25(a) - Reporting

Opportunities to challenge final adverse actions taken by FDA regarding approval of certification agencies or withdrawal of approval of certification agencies shall be communicated through notices of opportunity for informal hearings in accordance with 21 CFR Part 16.

21 CFR 900.3(f)(1) - Recordkeeping

An accreditation body that does not apply for renewal of accreditation, is denied such approval by FDA, or relinquishes its accreditation authority shall transfer facility records and other related information to a location approved by FDA.

21 CFR 900.4(g) - Recordkeeping

The accreditation body is required to develop and administer a written and documented system, including timeframes, for collecting and resolving serious consumer complaints that could not be resolved at a facility.

21 CFR 900.12(a)(1)(i)(B)(2)- Recordkeeping

Facilities are required to document that their interpreting physicians meet all applicable initial requirements. Additional documentation may be needed for foreign-trained physicians, resulting in an increased recordkeeping burden.

21 CFR 900.12(a)(4)- Recordkeeping

Facilities are required to document that their interpreting physicians, radiologic technologists, and medical physicists meet all applicable personnel requirements.

21 CFR 900.12(c)(4) - Recordkeeping

Facilities are required to maintain mammography films and reports in a permanent medical record of the patient.

21 CFR 900.12(e)(13) - Recordkeeping

Facilities shall establish and comply with a system specifying procedures to be followed by the facility for cleaning and disinfecting mammography equipment after contact with blood or other potentially infectious materials.

21 CFR 900.12(f) - Recordkeeping

Each facility is required to establish and maintain a mammography medical outcomes audit program. As part of that program, an interpreting physician is required to review the audit data at least once every 12 months. This individual is required to identify issues and analyze results based on this audit.

21 CFR 900.12(h)(2) - Recordkeeping

Each facility is required to establish a written and documented system for collecting and documenting consumer complaints and to maintain a record of each serious complaint received by the facility for at least 3 years.

21 CFR 900.22 (a) - Recordkeeping

A certification agency must establish and implement measures that FDA has approved to reduce the possibility of conflict of interest or facility bias on the part of individuals acting on the certification agency’s behalf.

21 CFR 900.22(d) - Recordkeeping

A certification agency must establish processes for the suspension and revocation of certificates and other enforcement actions. appeals, additional mammography review from accreditation bodies, and patient notification.

21 CFR 900.22(e) - Recordkeeping

A certification agency must establish processes for appeals of inspection findings, enforcement actions, and adverse certification decisions.

21 CFR 900.22(f) - Recordkeeping

A certification agency must establish processes for additional mammography review from accreditation bodies.

21 CFR 900.22(g) - Recordkeeping

A certification agency must establish processes for patient notification.

21 CFR 900.24(c) - Recordkeeping

A certification agency that has had its approval withdrawn must transfer facility records and other related information as directed by FDA.

21 CFR 900.25(b) - Recordkeeping

A facility that has been denied certification is entitled to an appeals process from the certification agency. The appeals process shall be specified in writing by the certification agency and shall have been approved by FDA.

Inspection Fee Exemption

Form FDA 3422 – Reporting

Under the MQSA, all certified mammography facilities except governmental entities, as determined by FDA, are subject to payment of inspection fees. The information provided by this form is used by FDA to determine if the facility is operated by any Federal department, State, district, territory, possession, Federally recognized Indian tribe, city, county, town, village, municipal corporation or similar political organization or subpart thereof. Collection of information from this form will also allow FDA to determine if the facility provides services under the Breast and Cervical Cancer Mortality Prevention Act of 1990.

2. By Whom and for What Purpose the Information is to be Used

This Information Collection is necessary to assure safe, accurate, and reliable mammography on a nationwide basis. Information collected from mammography facilities has been used to ensure that the personnel, equipment, and quality systems have met and continue to meet the regulations under MQSA and will be used by patients to manage their health care properly.

Certain provisions of the MQSA require that accreditation of mammography facilities by private, nonprofit organizations or State agencies and certification of mammography facilities by State agencies be approved by FDA according to standards established by FDA. FDA has used data from the current accreditation and certification process to ensure that the requirements of the final rule are met. The information collected for accreditation and certification bodies of mammography facilities has been and will continue to be used by FDA to ensure that private, nonprofit organization or State agencies have met the standards established by FDA for accreditation bodies to accredit and State certification agencies to certify facilities that provide mammography services.

3. Consideration of Information Technology

A particularly significant use of information technology in the MQSA program to reduce the reporting and recordkeeping burden is that the accreditation bodies and State certification agencies provide the required information to FDA almost entirely by electronic means. Most information currently is processed through the program’s electronic Mammography Program Reporting and Information System (MPRIS). Presently, accreditation bodies send information electronically through the use of web pages whereby data is updated. Inspection findings are reported electronically on the inspector’s laptop and then uploaded into the system. Information is transmitted to State certification agencies electronically. Compliance Officers and Regional Radiological Health Representatives (RRHR) modify non-compliance information found in the inspections. Billing files are created monthly and then sent electronically to a FDA contractor who then produces the bills. The MPRIS system is essentially paperless at this point, and currently meets Government Paperwork Elimination Act (GPEA) requirements.

Other examples of reducing burden through technology includes FDA’s permitting physician’s electronic signatures on medical reports and its acceptance of electronic recordkeeping in such areas as the medical audit, quality control, and patient reports. The use of electronic forms of reporting and recordkeeping submissions to FDA continues to remain voluntary at this point.

Any information generated for the patient’s use may be communicated to the patient in any appropriate format.

4. Efforts to Identify Duplication and Similar Information Already Available

The MQSA was enacted to establish uniform national quality standards for all mammography facilities. Under the previous regulatory system, no national comprehensive mammography quality standards existed. The American College of Radiology (ACR) is the principal professional organization of physicians trained in radiology and medical radiation physics in the United States. In 1987, the ACR began the voluntary Mammography Accreditation Program (MAP), the purpose of which was to provide assurance of quality to patients seeking services at ACR-accredited facilities. Today, ACR is performing their accreditation program under FDA authority.

While some of the information previously included in the MAP was the same as now required by FDA under this Information Collection, only those facilities that had voluntarily sought accreditation previous to October 1, 1994 (less than a quarter of the total) had provided this information to the ACR. Hence, the information being collected under the MQSA was not previously available for all facilities on a nationwide basis. FDA found no other information sources that were available. Because there is no similar information available to assure that mammography facilities are complying with the requirements of MQSA, the information requested under MQSA is not duplicative.

5. Impact on Small Business or Other Small Entities

FDA does not believe that the collection of information will adversely affect small businesses or other small entities. Because smaller facilities by definition have fewer employees and lower volumes of mammography examinations than large facilities, these facilities will have a lesser amount of recordkeeping and reporting burden. Thus, the amount of recordkeeping and reporting burden will be proportional to the volume of examinations at the mammography facility. Hence, facilities of all sizes will experience an equal burden in relative terms (i.e., small facilities will not be affected any more or less than large facilities).

FDA has also attempted to minimize the information collection burden on small entities by developing a small entity compliance guide. This guide was issued under section 212 of the Small Business Regulatory Enforcement Fairness Act of 1996. Subsequently, as additional questions arose with respect to complying with the regulations, FDA provided further guidance in answer to these questions. To date, twenty-one major guidance documents have been made available, one of which concentrated specifically on recordkeeping questions. In accordance with Good Guidance Practices, these documents were made available electronically to the public. As each document was issued, the information in it was incorporated into an electronic file called the Policy Help Guidance System. This file is available to the public on the FDA’s mammography Web Site www.fda/gov/cdrh/mammography, along with an incorporated search engine. Members of the public may consult the guidance on the Web Site or download it and the search engine to their own computer for more convenient use. This guidance, like the previously published compliance guide, is intended to help small entities comply with the final regulations.

There are situations where the facilities are required to submit information of interest to both the accreditation bodies and FDA or the State certification agency. From the beginning of the program, FDA has required only a single submission of this information. Typically the information is sent to the accreditation body, which then, as discussed above, transmits it electronically to FDA. This reduces the burden that would rise if the facility was required to submit the information directly both to FDA and the accreditation body.

Further, in the interest of maintaining flexibility while improving the overall quality of mammography, FDA has provided an avenue through which an effective alternative standard may be implemented. The Agency has created a mechanism for mammography facilities and accreditation bodies, State governments that are not accreditation bodies, and manufacturers and assemblers of equipment used for mammography to request permission to meet an alternative standard rather than an existing quality standard. The request must be supported by such evidence as required by the Agency to render a determination that the suggested alternative is at least as effective as the FDA-mandated standard in helping to achieve high quality mammography.

6. Consequences of Collecting the Information Less Frequently and Technical or Legal Obstacles

Less frequent information collection may result in an unacceptable quality of mammography being provided by many facilities. Neither the accreditation bodies, State certification agencies, nor FDA would be able to assure that facilities are adequately meeting the quality standards with less frequent information collection. FDA believes that the reporting and recordkeeping frequency in the final rule is the minimum necessary to assure safe, accurate, and reliable mammography on a nationwide basis

There are no technical or legal obstacles to the collection of this information.

7. Consistency with the Guidelines in 5 CFR 1320.5(d)(2)

This information collection is consistent with 5 CFR 1320.5(d).

8. Consultation Outside, the Agency

In accordance with 5 CFR 1320.8(d), on September 21, 2006 (71 FR 55488), a 60 day notice for public comment (Attachment C) was published in the Federal Register. No comments were received from the public in response to that notice.

FDA meets with its National Mammography Quality Assurance Advisory Committee (NMQAAC) annually. NMQAAC is made up of representatives of the mammography community, consumer and industry groups, and government. It is charged with advising FDA's mammography program on advances in mammography technology and procedures and on appropriate quality standards for mammography facilities. NMQAAC also discusses and comments on all guidances before they are made final. The meetings are open to the public and time is allotted for public statements on issues of concern in the mammography field. The chairperson may also call upon attendees to contribute to the committee discussions.

FDA also meets or holds teleconferences several times a year with its approved accreditation bodies and State certification agencies to discuss issues of mutual concern. The Agency has also long enjoyed a good relationship with the Conference of State Radiation Program Directors (CRCPD), which is the professional organization of the State agencies concerned with radiation protection. The CRCPD has established a standing Mammography Committee, which meets with FDA mammography staff at least once a year.

Finally, in recent years, FDA mammography staff have met several times with representatives of manufacturers working on the new applications of digital technology in mammography to resolve problems preventing the making of that technology generally available. FDA mammography staff have also worked with representatives of the manufacturers to develop quality assurance manuals for full field digital mammography units.

9. Explanation of any Payment of Gift to Respondents

No payment or gifts shall be provided to respondents under this regulation.

10. Assurance of Confidentiality Provided to Respondent

Under the Freedom of Information Act (FOIA) (5 U.S.C. 552), the public has broad access to government documents. However, FOIA provides certain exemptions from mandatory public disclosure of government records (5 U.S.C. 552(b)(1-9). FDA will make the fullest possible disclosure of records to the public, consistent with the rights of individuals to privacy, the property rights of persons in trade and confidential commercial or financial information. Mammography facility information submitted to FDA under 21 CFR Part 900 are releasable under the FOIA as set forth in 21 CFR Part 20.

Mammography reports and patient lay summaries issued under 21 CFR 900(c)(2) and (3) will only be available to the patient or concerned health officials.

11. Justification of Sensitive Questions

This information collection does not include questions pertaining to sexual behavior, attitude, religious beliefs, or any other matters that are commonly considered private or sensitive in nature.

12. Estimate of Hour Burden Including Annualized Hourly Costs

The most likely respondents to this information collection will be accreditation bodies, State certification agencies, and mammography facilities seeking certification.

The total estimated annual reporting and recordkeeping burden for meeting the regulations (summation of hours reported in information collection statements OMB No. 0910-0309 and 0910-0580) is 3,314,363 and is documented in the tables below. The previously reported estimate for the two supporting statements was 3,221,705.25 hours. The increase of 92,657.75 hours is explained in Section 15.

The total hour cost estimate for the annual reporting and recordkeeping burden is estimated to be $39,208,914. This estimate is based on data from the US Department of Labor’s Bureau of Labor Statistics for average national salaries in the recordkeeping and healthcare segments of the economy.

Table 1. --Estimated Annual Reporting Burden

CFR Section	Number of Respondents	Annual Frequency per Response	Total Annual Responses	Hours per Response	Total Hours	Total Capital Costs	Total Operating & Maintenance Costs
900.3(b)(1)	0.33	1	0.33	1	0.33
900.3(b)(3) full1	0.33	1	0.33	320	106	$10,000
900.3(b)(3) limited2	5	1	5	30	150
900.3(d)(2)	0.1	1	0.1	30	3
900.3(d)(5)	0.1	1	0.1	30	3
900.3(e)	0.1	1	0.1	1	0.1
900.3(f)(2)	0.1	1	0.1	200	20		$36
900.4(c) facility3	2,947	1	2,947	1.54	4,538
900.4(c) AB4	6	1	6	378	2,268		$117,867
900.4(d) facility3	2,947	1	2,947	0.77	2,269
900.4(d) AB4	6	1	6	189	1,134
900.4(e) facility3	8,840	1	8,840	1	8,840		$8,840
900.4(e) AB4	6	1	6	1473	8,838
900.4(f)	336	1	336	7	2,352		$77,840
900.4(h) facility3	8,840	1	8,840	1	8,840		$3,536
900.4(h) AB4	6	1	6	10	60
900.4(i)(2)	1	1	1	16	16
900.6(c)(1)	0.1	1	0.1	60	6
900.11(b)(3)	5	1	5	0.5	2.5
900.11(c)	270	1	270	5	1,350
900.12(c)(2)	8,840	4,072	36,000,000	0.083	3,000,000		$14,400,000
900.12(c)(2) patient refusal5	89	1	89	0.5	44.5
900.12(h)(4)	5	1	5	1	5
900.12(j)(1) facility3	25	1	25	200	5,000		$250
900.12(j)(1) AB4	25	1	25	1,000	25,000		$750
900.12(j)(2)	3	1	3	100	300		$3,604
900.15(c)	5	1	5	2	10
900.15(d)(3) (ii)	1	1	1	2	2
900.18(c)	2	1	2	2	4
900.18(e)	2	1	2	1	2
900.21(b)	1	1	1	320	320	$30,000	$71
900.21(c)(2)	0.33	1	0.33	30	10
900.22(h)	6	200	1200	0.083	100
900.22(i)	2	1	2	30	60
900.23	6	1	6	20	120
900.24(a)	0.3	1	0.3	200	60		$26
900.24(a)(2)	0.15	1	0.15	100	15		$13
900.24(b)	1.2	1	1.2	30	36
900.24(b)(1)	0.3	1	0.3	200	60		$26
900.24(b)(3)	0.15	1	0.15	100	15		$13
900.25(a)	0.2	1	0.2	16	3.2
FDA Form 3422	700	1	700	0.25	175
TOTAL					3,072,138	$40,000	$14,612,872

¹ Refers to entities that are applying for the first time.

² Refers to accreditation bodies applying to accredit specific FFDM units.

³ Refers to the facility component of the burden for this requirement.

⁴ Refers to the accreditation body component of the burden for this requirement.

⁵ Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.

Table 2. --Estimated Annual Recordkeeping Burden

CFR Section	Number of Recordkeepers	Annual Frequency of Recordkeeping	Total Annual Records	Hours per Recordkeeper	Total Hours	Total Capital Costs	Total Operating & Maintenance Costs
900.4(g)	6	1	6	1	6
900.12(a)(1)(i)(B)(2)	89	1	89	8	712
900.12(a)(4)	8,840	4	35,360	1	35,360
900.12(c)(4)	8,840	1	8,840	1	8,840	$25,000
900.12(e)(13)	8,840	52	459,680	0.083	38,154
900.12(f)	8,840	1	8,840	16	141,440
900.12(h)(2)	8,840	2	17,680	1	17,680
900.22(a)	6	1	6	1	6
900.22(d)	6	1	6	1	6
900.22(e)	6	1	6	1	6
900.22(f)	3	1	3	1	3
900.22(g)	6	1	6	1	6		$60
900.25(b)	6	1	6	1	6
TOTAL					242,225	$25,000	$60

The following regulations were not included in the above burden tables because they were considered usual and customary practice and were part of the standard of care prior to the implementation of the regulations. Therefore they resulted in no additional reporting or recordkeeping burden: 900.12(c)(1) and 900.12(c)(3).

The following regulations were not included in the above burden tables because they were not considered applicable during the Information Collection period or their burdens were reported under other regulatory requirements. Therefore they resulted in no additional reporting or recordkeeping burden: 900.3(c), 900.3(f)(1), 900.11(b)(1), 900.11(b)(2), and 900.24(c).

13. Estimate of the Other Total Annual Cost Burden to Respondents or Recordkeepers

A. Total Capital Cost

The total capital cost associated with these regulations is $65,000.

21 CFR 900.3(b)(3) $10,000

21 CFR 900.21(b) $30,000

21 CFR 900.12(c)(4) $25,000

B. Total Operating & Maintenance Cost

The total operating and maintenance cost associated with these requirements is $14,612,932. This is the cost that facilities bear to report and maintain records under the mammography regulations

21 CFR 900.3(f)(2) $36

21 CFR 900.4(c) $117,867

21 CFR 900.4(e) $8,840

21 CFR 900.4(f) $77,840

21 CFR 900.4(h) $3,536

21 CFR 900.12(c)(2) $14,400,000

21 CFR 900.12(j)(1) $1,000

21 CFR 900.12(j)(2) $3,604
21 CFR 900.21(b) $71

21 CFR 900.22(g) $60

21 CFR 900.24(a) $26
21 CFR 900.24(a)(2) $13
21 CFR 900.24(b)(1) $26
21 CFR 900.24(b)(3) $13

14. Annualized cost to the Federal Government

FDA is currently using 62 FTE's to implement the accreditation, quality standards, and certification provisions of the MQSA. The annual cost of these FTEs (including benefits) is 39 at $110,000 each, 21 at $92,000 each, and 2 at $103,000 each. The estimated total yearly cost is $6,428,000. The number of FTE’s has increased about 7 percent since the last approval of this information collection and the cost per FTE has increased about 13 per cent over the last three years. The total cost to the government since Mammography Information Collection OMB #0910­-0309 was last approved in 2004 has increased about 19 percent.

15. Explanation for Program Changes or Adjustments

FDA had previously estimated the annual burden for reporting and recordkeeping requirements under information collections 0910-0309 and 0910-0580 to be 3,221,705.25 hours. The current total burden estimate is 3,314,363 hours for an increase of 92,657.75 hours.

As is shown in Tables 1 and 2 the total estimated annual reporting burden is 3,072,138 hours and the total estimated annual recordkeeping burden is 242,225 hours for a total of 3,314,363 hours.

A number of factors contributed to the change in the number of hours and monetary costs in the current estimates. The most significant factors are:

• The hours for performing Additional Mammography Reviews and Patient/Physician Notifications as well as the associated operating costs were increased to better represent the actual burden on facilities and accreditation bodies.

• Accreditation body burden for performing routine clinical and phantom image review was underestimated in previous supporting statements.

• Transportation costs were included for performing onsite visits and random clinical image review.

• The need for existing accreditation bodies to apply to FDA for each type of full field digital mammography unit they accredit.

• In the previous supporting statement, the operating cost for providing lay summaries to all patients was discussed in the body of the statement but was not included in the appropriate section of the reporting table.

• In the previous supporting statement, when capital costs were identified they were reported as the cost to an individual respondent or recordkeeper. In this supporting statement, the total for all respondents or recordkeepers was used.

• The average number of mammography units per facility has increased to 1.54.

• There has been a decrease of 360 mammography facilities since the previous supporting statement.

• The number of States applying to become certifying agencies and the number of entities applying to become accreditation bodies is less than previously estimated.

16. Plans for Tabulation and Publication and Project Time Schedule

FDA does not intend to publish the results of this information collection.

17. Reason(s) Display of OMB Expiration Date is Inappropriate

Not Applicable

18. Exception to Certification for Paperwork Reduction Act Submissions

There are no exceptions to the certification statement identified in Item 19 of OMB Form 83-I.

B. COLLECTIONS OF INFORMATION EMPLOYING STATISTICAL METHODS

There are no statistical methods being employed in this collection of information.

List of Attachments

Attachment A Title 21 CFR Part 900 Mammography
Attachment B Mammography Quality Standards Act of 1992 (MQSA) as amended

(42 U.S.C. 263b)

Attachment C Federal Register of September 22, 2006 (71 FR 55488)

Attachment D Government Entity Declaration Form FDA-3422

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