[Federal Register Volume 61, Number 129 (Wednesday, July 3, 1996)]
[Notices]
[Pages 34847-34848]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 96-16970]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 96N-0186]


Agency Information Collection Activities: Proposed Collection; 
Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the agency. Under the Paperwork Reduction Act of 1995, 
Federal agencies are required to publish notice in the Federal Register 
concerning each proposed collection of information and to allow 60 days 
for public comment in response to the notice. This notice solicits 
comments on a proposed survey of mammography facilities to assess the 
impact of proposed regulations required by the Mammography Quality 
Standards Act of 1992 (the MQSA).

DATES: Submit written comments on the collection of information by 
September 3, 1996.

ADDRESSES: Submit written comments on the collection of information to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
12420 Parklawn Dr., rm. 1-23, Rockville, MD 20857. All comments should 
be identified with the docket number found in brackets in the heading 
of this document.

FOR FURTHER INFORMATION CONTACT: Charity B. Smith, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, rm. 16B-19, Rockville, MD 20857, 
301-827-1686.

SUPPLEMENTARY INFORMATION: Section 3506(c)(2)(A) of the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3506(c)(2)(A)) requires Federal 
agencies to provide a 60-day notice in the Federal Register concerning 
each proposed collection of information. ``Collection of information'' 
is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c). To comply with 
this requirement, FDA is publishing notice of the proposed collection 
of information listed below.
    With respect to the following collection of information, FDA 
invites comments on: (1) Whether the proposed collection of information 
is necessary for the proper performance of FDA's functions, including 
whether the information will have practical utility; (2) the accuracy 
of FDA's estimate of the burden of the proposed collection of 
information, including the validity of the methodology and assumptions 
used; (3) ways to enhance the quality, utility, and clarity of the 
information to be collected; and (4) ways to minimize the burden of the 
collection of information on respondents, including through the use of 
automated collection techniques, when appropriate, and other forms of 
information technology.


FDA Survey of Mammography Facilities

    The MQSA of 1992 (Pub. L. 102-539) has resulted in regulatory 
efforts by FDA to ensure high quality standards for mammography in the 
United States. In the Federal Register of April 3, 1996 (61 FR 14856), 
FDA proposed final regulations to implement these standards. Interim 
regulations are codified at 21 CFR 900. In connection with this 
rulemaking, FDA proposes to conduct a survey of facilities to determine 
current operating costs and procedures. The information to be collected 
from the proposed survey includes general provider characteristics, 
equipment characteristics, facility operating procedures, personnel 
qualifications, and costs of compliance with current quality standards. 
This information is necessary in order to ensure that costs to affected 
facilities are minimized to the extent consistent with maintenance of 
high quality mammography services, and that patient access to 
mammography services is not diminished as a result of agency action.
    The proposed survey will be a one-time data collection effort. 
Surveys will be mailed to 1,000 randomly selected facilities. 
Facilities will be contacted by telephone in order to respond to any 
specific issues, or questions that may arise. Responses will not be 
mandatory, and no facility will be required to respond. All responses 
will be kept confidential, although a compilation of data that does not 
reveal facility-specific information will be made available upon 
request to participants and to the public. A toll-free telephone number 
will be installed to allow respondents the opportunity to call if 
specific issues arise.
    FDA estimates the burden of this one-time survey as follows:

                                        ESTIMATED ANNUAL REPORTING BURDEN                                       
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                                      Annual                                                                    
 Burden Element       No. of       Frequency per   Total Annual      Hours per      Total Hours     Total Costs 
                    Respondents      Response        Responses       Response                                   
----------------------------------------------------------------------------------------------------------------
Initial Contact                                                                                                 
 by Telephone       1,000               1           1,000               0.083          83          $1,385       
Compile                                                                                                         
 Requested                                                                                                      
 Information          702               1             702               1.0           702         $11,716       

[[Page 34848]]

                                                                                                                
Mail-in Response      200               1             200               0             N/A             N/A       
Telephone                                                                                                       
 Followup             800               1             800               0.083          67          $1,118       
Responses by                                                                                                    
 Telephone                                                                                                      
 Interview            480               1             480               0.5           240          $4,006       
Mail-In Response                                                                                                
 After Receiving                                                                                                
 Followup              22               1              22               0             N/A             N/A       
Total Burden                                                                        1,092         $18,225       
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There are no capital costs or continuing operating and maintenance costs associated with this survey. These     
  burden estimates include the time for reviewing instructions, searching existing data sources, gathering the  
  data needed, and completing and reviewing the collection of information. The hour and cost burden estimates   
  were derived from a pretest of nine randomly selected facilities.                                             



    Dated: June 26, 1996.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 96-16970 Filed 7-2-96; 8:45 am]
BILLING CODE 4160-01-F