[Federal Register Volume 69, Number 26 (Monday, February 9, 2004)]
[Notices]
[Pages 5991-5993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2641]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0482]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Mammography 
Facilities, Standards, and Lay Summaries for Patients

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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SUMMARY:  The Food and Drug Administration (FDA) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES:  Fax written comments on the collection of information by March 
10, 2004.

ADDRESSES: The Office of Management and Budget (OMB) is still 
experiencing significant delays in the regular mail, including first 
class and express mail, and messenger deliveries are not being 
accepted. To ensure that comments on the information collection are 
received, OMB recommends that comments be faxed to the Office of 
Information and Regulatory Affairs, OMB, Attn: Fumie Yokota, Desk 
Officer for FDA, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT:  Peggy Robbins, Office of Management 
Programs (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 5992]]

Mammography Facilities, Standards, and Lay Summaries for Patients--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 Sec. 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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                                                          Annual
           21 CFR Section                Number of     Frequency per    Total Annual      Hours per      Total Hours    Total Capital  Total Operating &
                                        Respondents      Response        Responses        Response                          Costs      Maintenance Costs
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900.3                                              1            0.33             0.33              60              20  ..............  .................
900.3(b)(3)                                        1            0.33             0.33              60              20             $50  .................
900.3(c)                                           5            0.33             1.67              15              25  ..............  .................
900.3(e)                                           1             0.1              0.1               1             0.1  ..............  .................
900.3(f)(2)                                        1             0.1              0.1             200              20  ..............  .................
900.4(c)&(2)                                   9,200            0.33            3,067               1           3,067  ..............  .................
900.4(e)                                       9,450               1            9,450               8          75,600  ..............  .................
900.4(f)                                         276               1              276               7           1,932  ..............  .................
900.4(h)                                           5               1             6130               1           6,130  ..............  .................
900.4(i)(2)                                        1            0.33             0.33               1            0.33  ..............  .................
900.6(c)(1)                                        1             0.1              0.1               1             0.1  ..............  .................
900.11(b)(1)                                   9,200            0.33            3,067               2           6,134  ..............  .................
900.11(b)(2)                                     250               1              250               2             500  ..............  .................
900.11(b)(3)                                       5               1                5              .5             2.5  ..............  .................
900.11(c)                                      9,200            0.04              368               5           1,840  ..............             $1,000
900.12(c)(2)                                   9,200           3,478       36,000,000       5 minutes       3,000,000  ..............  .................
900.12(j)(1)                                      25               1               25               1              25  ..............  .................
900.12(j)(2)                                      25            0.08                2              50             100  ..............  .................
900.15(c)                                      9,200            0.05               46               2              92  ..............  .................
900.15(d)(3)(ii)                               9,200          0.0001             0.92               2             1.8  ..............                $10
900.18(c)                                      9,300         0.00032                3               2               6  ..............                $30
900.18(e)                                         10          0.0100              0.1               1            0.10  ..............                $10
FDA Form 3422                                    800               1              800             .25             200  ..............  .................
Total                                 ..............  ..............  ...............  ..............       3,095,716             $50             $1,040
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                                                   Table 2.--Estimated Annual Recordkeeping Burden\1\
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                                            Number of       Annual Frequency     Total Annual        Hours per                         Total Operating &
            21 CFR Section                Recordkeepers     of Recordkeeping       Records          Recordkeeper       Total Hours     Maintenance Costs
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900.3(f)(1)                                             5               0.02                0.1                200                 20  .................
900.4(g)                                                1               0.33               0.33                  1               0.33  .................
900.12(c)(4)                                        9,200                  1              9,200                  1              9,200            $18,400
900.12(e)(13)                                       9,200                 52            478,400              0.125             59,800  .................
900.12(f)                                           9,200                  1              9,200                  5             46,000  .................
900.12(h)                                           9,200                  2             18,400                0.5              9,200  .................
Total                                   .................  .................  .................  .................            124,220           $18,400
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\1\There are no capital costs associated with this collection of information.

    The most likely respondents to this information collection will be 
accreditation bodies and mammography facilities seeking certification. 
The total capital cost associated with these regulations is $50 (Sec. 
900.3(b)(3)). This is a one-time start up cost associated with the 
application for approval as an accreditation body. The total operating 
and maintenance cost associated with these requirements is $19,440. 
This is the cost that facilities bear to maintain

[[Page 5993]]

records under the initial and final mammography regulations.

    Dated: January 29, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-2641 Filed 2-6-04; 8:45 am]
BILLING CODE 4160-01-S