[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

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        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