[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
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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
