[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
[[Page 13257]]
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.
[[Page 13258]]
Dated: March 8, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-6906 Filed 3-17-98; 8:45 am]
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