[Federal Register Volume 63, Number 52 (Wednesday, March 18, 1998)]
[Notices]
[Pages 13256-13258]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-6906]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98N-0147]


Agency Information Collection Activities: Proposed Collection; 
Survey of Mammography Facilities; 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 
(the PRA), Federal agencies are required to publish notice in the 
Federal Register

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concerning each proposed collection of information, including each 
proposed extension of an existing collection of information, and to 
allow 60 days for public comment in response to the notice. This notice 
solicits comments on a voluntary survey of mammography facilities to 
assess the impact of the Mammography Quality Standards Act (the MQSA) 
on access to mammography services.

DATES: Submit written comments on the collection of information by May 
18, 1998.

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: Margaret R. Schlosburg, Office of 
Information Resources Management (HFA-250), Food and Drug 
Administration, 5600 Fishers Lane, Rockville, MD 20857, 301-827-1223.

SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal 
agencies must obtain approval from the Office of Management and Budget 
(OMB) for each collection of information they conduct or sponsor. 
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR 
1320.3(c) and includes agency requests or requirements that members of 
the public submit reports, keep records, or provide information to a 
third party. Section 3506(c)(2)(A) of the PRA (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, including 
each proposed extension of an existing collection of information, 
before submitting the collection to OMB for approval. 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.

Access to Mammography Services Survey--New

    Under the MQSA (42 U.S.C. 2636), FDA is authorized to develop 
regulations, inspect facilities, and ensure compliance with standards 
established to assure quality mammography services for all women. In 
the legislative history of the MQSA, Congress expressed the need to 
balance quality improvements with impact on access to mammography 
services. The General Accounting Office has recently done an assessment 
and concluded that access has been minimally affected. However, new 
regulations will become effective April 28, 1999 and October 28, 2002.
     The Mammography Facility Survey will provide FDA with important 
information about the impact of specific aspects of the MQSA program on 
access to mammography services. The survey will provide facility 
closure rates both pre- and post-implementation of the final 
regulations. Furthermore, the Survey will determine reasons for 
facility closures, including those related to specific MQSA regulations 
and those that are attributable to general operational challenges. 
Finally, the Survey will also gather information from operating 
facilities to determine the impact of MQSA regulations on facilities 
that continue to provide mammography services. Participation will be 
voluntary. A total of 120 facilities that have ceased to provide 
mammography services will be given the opportunity to take part in a 
15-minute telephone survey. These facilities will be matched by zipcode 
to 480 open mammography centers to provide up to four controls for each 
closed facility . Each of the open facilities will also be offered the 
opportunity to participate in the study until we have two matched 
controls. The Survey will collect demographic information from each 
survey respondent, and then ask questions that address the perceived 
impact on the facility's ability to provide mammography services of 
factors related to specific MQSA regulations, as well as factors not 
directly associated with MQSA requirements. Additional descriptive 
information about the facilities will be abstracted from various FDA 
data bases in order to enhance the level of detail that is known about 
each respondent.
    FDA estimates the burden of this collection of information as 
follows:

                                  Table 1.--Estimated Annual Reporting Burden1                                  
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                                                      Annual                                                    
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours 
                                                     Response        Responses       Response                   
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720                                                     1             720               0.25          180       
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\1\There are no capital costs or operating and maintenance costs associated with this collection of information.



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    Dated: March 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-6906 Filed 3-17-98; 8:45 am]
BILLING CODE 4160-01-F