The Mammography Quality Standards Act Final Regulations: Modifications and Aditions to Policy Guidance Help System #9

ICR 200512-0910-006

OMB: 0910-0580

Federal Form Document

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0910-0580 200512-0910-006
Historical Active
HHS/FDA
The Mammography Quality Standards Act Final Regulations: Modifications and Aditions to Policy Guidance Help System #9
New collection (Request for a new OMB Control Number)   No
Regular
Approved without change 03/17/2006
Retrieve Notice of Action (NOA) 12/29/2005
  Inventory as of this Action Requested Previously Approved
03/31/2009 03/31/2009
1,007 0 0
1,194 0 0
0 0 0

This guidance document provides guidance to mammography facilities and their personnel on involving the quality standards for mammography (21 CFR 900.12). This guidance document provides information on how to address a patient's refusal to receive a lay summary and recommends that the facility document why it was unable to meet this requirement. Additionally, it addresses interpreting physician initial requirements (21 CFR 900.12(a) (1)(i)(B)(2)), including recommendations on how to document the alternative to Board Certification for foreign-trained physicians.

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1
IC Title Form No. Form Name
The Mammography Quality Standards Act Final Regulations: Modifications and Aditions to Policy Guidance Help System #9

  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 1,007 0 0 1,007 0 0
Annual Time Burden (Hours) 1,194 0 0 1,194 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
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.
12/29/2005


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