Mammography Facilities, Standards, and Lay Summaries For Patients

ICR 200010-0910-004

OMB: 0910-0309

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
IC Document Collections
ICR Details
0910-0309 200010-0910-004
Historical Active 199710-0910-005
HHS/FDA
Mammography Facilities, Standards, and Lay Summaries For Patients
Extension without change of a currently approved collection   No
Regular
Approved without change 02/02/2001
Retrieve Notice of Action (NOA) 10/31/2000
  Inventory as of this Action Requested Previously Approved
03/31/2004 03/31/2004 02/28/2001
39,996,722 0 12,821
3,516,183 0 184,510
21,000 0 21,000

The FDA is implementing the Mammography Quality Standards Act of 1992 (MQSA) as amended by the Mammography Quality Standards Reauthorization Act (MQSRA) of 1998. The MQSA requires the establishment of a Federal certification and inspection program mammography facilities; regulations and standards for accreditation bodies; and standards for mammography equipment. MQSRA extended the life of MQSA for four years and modified some provisions, most notably requiring mammography facilities to send a lay summary of each examination to the patient. The intent to these regulations is to asure safe, reliable, and......

None
None


No

1
IC Title Form No. Form Name
Mammography Facilities, Standards, and Lay Summaries For Patients FDA-3422

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 39,996,722 12,821 0 0 39,983,901 0
Annual Time Burden (Hours) 3,516,183 184,510 0 0 3,331,673 0
Annual Cost Burden (Dollars) 21,000 21,000 0 0 0 0
No
No

$0
No
No
Uncollected
Uncollected
Uncollected
Uncollected

  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.
10/31/2000


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