[Federal Register Volume 63, Number 141 (Thursday, July 23, 1998)]
[Notices]
[Pages 39581-39582]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-19635]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

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


Agency Information Collection Activities; Submission for OMB 
Review; Comment Request

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that the 
proposed collection of information listed below has been submitted to 
the Office of Management and Budget (OMB) for review and clearance 
under the Paperwork Reduction Act of 1995 (the PRA).

DATES: Submit written comments on the collection of information by 
August 24, 1998.

ADDRESSES: Submit written comments on the collection of information to 
the Office of Information and Regulatory Affairs, OMB, New Executive 
Office Bldg., 725 17th St. NW., rm. 10235, Washington, DC 20503, Attn: 
Desk Officer for FDA.

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: In compliance with section 3507 of the PRA 
(44 U.S.C. 3507), FDA has submitted the following proposed collection 
of information to OMB for review and clearance.

Access to Mammography Services Survey--New

    Under the Mammography Quality Standards Act (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 MQSA, 
Congress expressed the need to balance quality improvements with impact 
on access to mammography services. The Government Accounting Office 
(GAO) has recently done an assessment and concluded that access has 
been minimally affected. However, new regulations will become effective 
April 28, 1999.
     The Mammography Facility Survey (the survey) will provide FDA 
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 460 facilities (240 annually) that have

[[Page 39582]]

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 zip code (and by facility type and size, within zip code) to 
1,840 open mammography centers (960 annually) 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 up until we 
have two matched control completed interviews. The survey will collect 
demographic information from each survey respondent and then proceed to 
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 databases in order to enhance the 
level of detail that is known about each respondent.
     In the Federal Register of March 18, 1998 (63 FR 13256), the 
agency requested comments on the proposed collection of information 
using the Mammography Facility Survey. FDA received one response to the 
docket, which was generally supportive of the proposed survey. This 
comment, however, recommended that the survey address two issues, which 
are described in the next two paragraphs along with FDA's responses.
     The first issue stated that some facilities apply for 
accreditation/certification but are denied several times. Ultimately 
they withdraw from the MQSA process, and reapply using a different name 
or address. The concern mentioned in the comment is that such 
facilities are ``inflating the actual number of facilities that have 
been negatively impacted by the cost and time involved in lawfully 
performing quality mammography services.'' FDA's response to this 
comment is twofold. First, the Mammography Facility Survey is not 
intended to estimate the rate at which facilities are closing, so the 
issue of considering such facilities as being closed when they are 
planning to reapply (and, thus, overestimating the rate of facility 
closure) is not relevant to this study. This study is intended to 
examine factors that distinguish closed from open facilities. For this 
purpose, a facility such as those described in the comment can 
legitimately be considered closed at the time of the survey. Second, 
the survey does collect information about each facility's 
accreditation/certification history, and the length of time the 
facility has been closed, its current status, and its plans for 
reapplying for accreditation in the near future.
     The second issue stated that many time-consuming activities 
included in the inspection phase of the MQSA process could be performed 
during the accreditation/certification phase and, thus, ``reduce the 
time and cost of the entire process to the mammography facility,'' as 
well as ``achieve a more uniform application of the requirements and 
minimize the impact to patient care/access.'' The comment suggested 
that the survey should explore the effects of reviewing both staff's 
professional qualifications and the medical physicist's annual survey 
of mammography machines during the accreditation/certification process. 
FDA views this comment as pertaining more to FDA policy regarding the 
timing of the two particular reviews mentioned in the comment. FDA's 
policy has been carefully developed to require both staff professional 
qualifications and a medical physicist's survey of mammography machines 
on a yearly basis (rather than on a triennial basis). Any change in 
this policy is not the focus of the current survey, although this study 
will gather information that might suggest whether the policy should be 
re-examined. Any facility that responds that the inspection process or 
the accreditation/certification process was a ``major problem'' in 
terms of money and/or time is asked to describe the nature of the 
problem. Thus, the responses to these survey items will indicate 
whether various aspects of the inspection and/or accreditation/
certification processes are very burdensome to facilities. FDA 
estimates the burden of this collection of information as follows:

                                  Table 1.-- Estimated Annual Reporting Burden<SUP>1                                 
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                                                      Annual                                                    
               No. of Respondents                  Frequency per   Total Annual      Hours per      Total Hours 
                                                     Response        Responses       Response                   
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Screener: 648                                           1             648               0.033          21       
Interview: 648                                          1             648                .25          162       
Total                                                                                                 183       
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of            
  information.                                                                                                  

    The number of facilities to be included in the study have increased 
from the estimate in FDA's previous notice seeking comment on this 
collection of information (63 FR 13256, March 18, 1998). This is 
because the numbers in the previous estimate were too low and 
represented a study period of only 6 months, which is not enough time 
to obtain interviews both before and after the final implementation of 
the MQSA regulations on April 28, 1999. The change in the matching 
factors is an outcome of the pilot study that revealed the large range 
in types of mammography facilities responding to the survey.

    Dated: July 13, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-19635 Filed 7-22-98; 8:45 am]
BILLING CODE 4160-01-F