[Federal Register Volume 65, Number 208 (Thursday, October 26, 2000)]
[Notices]
[Pages 64222-64224]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-27453]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00N-1373]


Agency Information Collection Activities; Submission for OMB 
Review; 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 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.

DATES: Submit written comments on the collection of information by 
November 27, 2000.

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: 
Wendy Taylor, Desk Officer for FDA.

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

[[Page 64223]]

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.
    In the Federal Register of July 17, 2000 (65 FR 44061), the agency 
requested comments on the proposed collection of information. No 
comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                   Table 1.--Estimated Annual Reporting Burden
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                                                                                                         Total
                                  Annual                                                     Total    Operating
     21 CFR         No. of      Frequency     Total Annual     Hours per     Total Hours    Capital      and
    Section      Respondents  per Response     Responses       Response                      Costs   Maintenance
                                                                                                        Costs
----------------------------------------------------------------------------------------------------------------
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              1            0.2
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
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
900.15(d)(3)(i   10,000            0.0020           20                2           40                    $100
 i)
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 Burden1
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                                                                                                       Total
                      No. of          Annual       Total Annual      Hours per                     Operating and
 21 CFR Section    Recordkeepers   Frequency of       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

[[Page 64224]]

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: October 19, 2000.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 00-27453 Filed 10-25-00; 8:45 am]
BILLING CODE 4160-01-F