[Federal Register Volume 70, Number 250 (Friday, December 30, 2005)]
[Notices]
[Pages 77401-77402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E5-8111]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2005D-0195]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Mammography Quality Standards Act 
Final Regulations; Modifications and Additions to Policy Guidance Help 
System 9

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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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 January 
30, 2006.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. To ensure that comments on the information collection are 
received, OMB recommends that comments be faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Fumie

[[Page 77402]]

Yokota, Desk Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Denver Presley, Office of Management 
Programs (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.

Mammography Quality Standards Act Final Regulations; Modifications and 
Additions to Policy Guidance Help System 9

    The Mammography Quality Standards Act (MQSA) Final Regulations: 
Modifications and Additions to Policy Guidance Help System 9 provides 
guidance to mammography facilities and their personnel on a variety of 
issues involving the quality standards for mammography (Sec.  900.12 
(21 CFR 900.12)). Use of the guidance results in new collections of 
information. Facilities are required to provide patients with lay 
summaries of the results of their mammography examinations (Sec.  
900.12(c)(2)). 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, the guidance addresses interpreting physician initial 
requirements (Sec.  900.12(a)(1)(i)(B)(2)), including recommendations 
on how to document the alternative to Board Certification for foreign-
trained physicians.
    The likely respondents are mammography facilities and their 
personnel who are subject to the MQSA quality standards requirements.
    In the Federal Register of July 15, 2005 (70 FR 41043), FDA 
published a 60-day notice requesting comments on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                 Table 1.--Estimated Annual Reporting Burden\1\
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                   Number of        Annual Frequency of      Total Annual          Hours per
  Activity        Respondents            Response              Responses            Response        Total Hours
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Reporting                     915                     1                   915                0.5             458
 of refusal
 of lay
 summary
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
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                   Number of       Annual Frequency per
  Activity       Recordkeepers            Record         Total Annual Records   Hours Per Record    Total hours
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Documentati                    92                     1                    92                  8             736
 on of
 foreign-
 trained
 physicians
 '
 qualificat
 ions
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    There are a total of 9,150 MQSA-certified facilities. Using past 
experience, FDA estimates that 10 percent of these facilities will 
receive patient requests that lay summary results not be sent. We also 
estimate that the facility will spend 0.5 hours per patient obtaining 
the patient's written request, filing that form in the patient's record 
and forwarding the summary to the patient's designee. With respect to 
foreign-trained physicians, past experience indicates that this 
situation arises very infrequently. We estimate that only 1 percent of 
MQSA-certified facilities will have to maintain records documenting the 
qualifications of foreign-trained physicians.

    Dated: December 22, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. E5-8111 Filed 12-29-05; 8:45 am]
BILLING CODE 4160-01-S