72 FR 31 pgs. 7438-7440 - Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements
Type: NOTICEVolume: 72Number: 31Pages: 7438 - 7440
Docket number: [Docket No. 2006N-0381]
FR document: [FR Doc. E7-2578 Filed 2-14-07; 8:45 am]
Agency: Health and Human Services Department
Sub Agency: Food and Drug Administration
Official PDF Version: PDF Version
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2006N-0381]
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements
AGENCY:
Food and Drug Administration, HHS.
ACTION:
Notice.
SUMMARY:
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
DATES:
Fax written comments on the collection of information by March 19, 2007.
ADDRESSES:
To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: 202-395-6974.
FOR FURTHER INFORMATION CONTACT:
Denver Presley, Jr., Office of the Chief Information Officer (HFA-250), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1472.
SUPPLEMENTARY INFORMATION:
In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance.
The Mammography Quality Standards Act Requirements-21 CFR Part 900 (OMB Control Number 0910-0309)-Extension
Mammography Quality Standards Act 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. The intent of these regulations is to ensure 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 an 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.
In the Federal Register of September 22, 2006 (71 FR 55488), FDA published a 60-day notice soliciting public comments on the information collection requirements of the proposed collection. In response to that notice, no comments were received.
FDA estimates the burden of this collection of information as follows:
| 21 CFR Section/ FDA Form | No. 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 | 1,473 | 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 | $14,400,0005 | |
| 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) | 0.3 | 1 | 0.33 | 30 | 10 | ||
| 900.22(h) | 6 | 200 | 1,200 | 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 Full Field Digital Mammography 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. | |||||||
| 21 CFR Section | Number of Recordkeepers | Annual Frequency of Recordkeeping | Total Annual Records | Hours per Record | 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 |
This request for OMB approval now serves to consolidate previously issued information collection, OMB control number 0910-0580 into 0910-0309. The hourly burden as well as the associated operating costs were increased to better represent the actual burden and costs on facilities and accreditation bodies.
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: 21 CFR 900.12(c)(1) and (c)(3) and § 900.3(f)(1) (21 CFR 900.3(f)(1)).
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), 21 CFR 900.11(b)(1) and (b)(2), and 900.24(c).
Dated: February 8, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E7-2578 Filed 2-14-07; 8:45 am]
BILLING CODE 4160-01-S