[Federal Register Volume 65, Number 137 (Monday, July 17, 2000)]
[Notices]
[Pages 44061-44062]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-17944]
[[Page 44061]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00N-1373]
Agency Information Collection Activities: Proposed Collection;
Comment Request; Reporting and Recordkeeping Requirements for
Mammography Facilities
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 concerning each proposed collection of information,
including each proposed extension of an existing information
collection, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on information collection
requirements for mammography facilities, standards, and lay summaries
for patients.
DATES: Submit written comments on the collection of information by
September 15, 2000.
ADDRESSES: Submit written comments on the collection of information to
the Dockets Management Branch (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should
be identified with the docket number found in brackets in the heading
of this document.
FOR FURTHER INFORMATION CONTACT: Peggy 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 set forth in this document.
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.
Reporting and Recordkeeping Requirements for Mammography
Facilities--21 CFR Part 900 (OMB Control Number 0910-0309)--
Extension
Public Law 102-539, the Mammography Quality Standards Act of 1992
(MQSA) (42 U.S.C. 263b) as amended by the Mammography Quality Standards
Reauthorization Act (MQSRA) of 1998 (Public Law 105-248) establishes
the authority for a Federal certification and inspection program for
mammography facilities; regulations and standards for accreditation
bodies for mammography facilities; and standards for mammography
equipment, personnel, and practices, including quality assurance. MQSRA
extended the life of the MQSA program for 4 years from its original
expiration date of 1998 until 2002, and also modified some of the
provisions. The most significant modification from a report and
recordkeeping viewpoint under 21 CFR 900.12(c)(2) was that mammography
facilities were required to send a lay summary of each examination to
the patient.
FDA, under this regulation, collects information from accreditation
bodies and mammography facilities by requiring each accreditation body
to submit an application for approval and to establish a quality
assurance program. On the basis of accreditation, facilities are
certified by FDA and must prominently display their certificate. FDA
uses the information to ensure that private, nonprofit organizations or
State agencies meet the standards established by FDA for accreditation
bodies to accredit facilities that provide mammography services.
Information collected from mammography facilities has also been used to
ensure that the personnel, equipment, and quality systems has and
continues to meet the regulations under MQSA and will be used by
patients to manage their health care properly. The intent of these
regulations is to assure safe, reliable, and accurate mammography on a
nationwide level. The most likely respondents to this information
collection will be accreditation bodies and mammography facilities
seeking certification.
FDA estimates the burden of this collection of information as
follows:
Table 1.--Estimated Annual Reporting Burden
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Total
No. of Annual Total Annual Total Operating &
21 CFR Section Respondents Frequency per Responses Hours per Response Total Hours Capital Maintenance
Response Costs Costs
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900.3 6 1 6 60 360
900.3(b)(3) 10 1 10 60 600 $50
900.3(c) 4 0.14 0.56 15 8.4
900.3(e) 1 0.2 0.2 1 0.2
900.3(f)(2) 1 0.2 0.2 200 40
900.4(c) 834 1 834 1 834
900.4(e) 10,000 1 10,000 8 80,000
900.4(f) 1,000 1 1,000 14.5 14,500
900.4(h) 6 1 750 6 4,500
900.4(i)(2) 1 1 1 1 1
900.6(c)(1) 1 1 1 1 1
900.11(b)(2) 25 1 25 2 50
900.11(b)(3) 5 1 5 0.5 2.5
[[Page 44062]]
900.11(c) 10,000 0.0050 50 20 1,000 $1,000
900.12(c)(2) 9,800 4,080 39,984,000 5 Minutes 3,332,000
900.12(j)(1) 10 1 10 1 10
900.12(j)(2) 1 1 1 50 50
900.15(d)(3)(ii) 10,000 0.0020 20 2 40 $100
900.18(c) 10,000 0.0005 6 2 12 $60
900.18(e) 10 0.1000 1 1 1 $10
TOTAL 3,434,010 $50 $1,170
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Table 2.--Estimated Annual Recordkeeping Burden \1\
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Total
No. of Annual Total Annual Hours per Operating &
21 CFR Section Recordkeepers Frequency per Records Recordkeeper Total Hours Maintenance
Recordkeeping Costs
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900.3(f)(1) 10 130 1,300 200 2,000
900.4(g) 10,000 1 10,000 1 10,000
900.11(b)(1) 1,000 1 1,000 1 1,000
900.12(c)(4) 10,000 1 10,000 1 10,000
900.12(e)(13) 6,000 52 312,000 0.125 39,000
900.12(f) 10,000 1 10,000 1 10,000
900.12(h) 10,000 2 20,000 0.5 10,000 $20,000
TOTAL 82,000 $20,000
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\1\ There are no capital costs associated with this collection of information.
All costs of implementing requirements for certification of
mammography facilities will be borne by accreditation bodies; the
incremental costs that accreditation bodies will face are not expected
to be significant. The collection's burden is based upon the estimated
number of summaries received by FDA, which in turn is based on the
estimated number of examinations expected to be performed in a given
year. If mammography examinations increase in number in subsequent
years, which is expected for at least the foreseeable future, the
annual burden and costs to meet this requirement will increase.
Included in the burden estimate is the FDA estimate for mammography
lay summaries, which is the practice of notifying the patient in
layman's terms of the results of the patient's mammography examination.
FDA estimates that there are 9,800 facilities performing mammography in
the United States. FDA also estimates that those facilities perform a
total of 40 million mammography examinations in a year. In 90 percent
of these cases, the notification to the patient can be established by a
brief standardized letter to the patient. FDA estimates that preparing
and sending this letter will take approximately 5 minutes. In the 10
percent of the cases in which there is a finding of ``Suspicious'' or
``Highly suggestive of malignancy,'' the facility is required to make
reasonable attempts to ensure that the results are communicated to the
patients as soon as possible. FDA believes that this requirement can be
met by a 5 minute call from the health professional to the patient.
Dated: July 10, 2000.
William K. Hubbard,
Senior Associate Commissioner for Policy, Planning, and Legislation.
[FR Doc. 00-17944 Filed 7-14-00; 8:45 am]
BILLING CODE 4160-01-F