[Federal Register Volume 68, Number 216 (Friday, November 7, 2003)]
[Notices]
[Pages 63106-63108]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-28006]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003N-0482]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; Mammography Facilities, Standards, and Lay Summaries 
for Patients

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

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

[[Page 63107]]

information collection requirements for mammography facilities, 
standards, and lay summaries for patients under part 900 (21 CFR part 
900).

DATES: Submit written or electronic comments on the collection of 
information by January 6, 2004.

ADDRESSES: Submit electronic comments on the collection of information 
to: http://www.fda.gov/dockets/ecomments. Submit written comments on 
the collection of information to the Division of Dockets Management 
(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 Robbins, Office of Management 
Programs (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 listed below.
    With respect to the following collection of information, FDA 
invites comments on these topics: (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.

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 Recording Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                                                                        Total
                                    Annual                                                   Total    Operating
  21 CFR        Number of       Frequency per     Total Annual       Hours per      Total   Capital      and
 Section   [chyph]Respondents  [chyph]Response  [chyph]Responses  [chyph]Response   Hours    Costs   Maintenance
                                                                                                        Costs
----------------------------------------------------------------------------------------------------------------
900.3      1                   0.33             0.33              60               20       .......  ...........
----------------------------------------------------------------------------------------------------------------
900.3(b)(  1                   0.33             0.33              60               20       $50      ...........
 3)
----------------------------------------------------------------------------------------------------------------
900.3(c)   5                   0.33             1.67              15               25       .......  ...........
----------------------------------------------------------------------------------------------------------------
900.3(e)   1                   0.1              0.1               1                0.1      .......  ...........
----------------------------------------------------------------------------------------------------------------
900.3(f)(  1                   0.1              0.1               200              20       .......  ...........
 2)
----------------------------------------------------------------------------------------------------------------
900.4(c)   9,200               0.33             3,067             1                3,067    .......  ...........
 and (d)
----------------------------------------------------------------------------------------------------------------
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                6,130             1                6,130    .......  ...........
----------------------------------------------------------------------------------------------------------------
900.4(i)(  1                   0.33             0.33              1                0.33     .......  ...........
 2)
----------------------------------------------------------------------------------------------------------------

[[Page 63108]]

 
900.6(c)(  1                   0.1              0.1               1                0.1      .......  ...........
 1)
----------------------------------------------------------------------------------------------------------------
900.11(b)  9,200               0.33             3,067             2                6,134    .......  ...........
 (1)
----------------------------------------------------------------------------------------------------------------
900.11(b)  250                 1                250               2                500      .......  ...........
 (2)
----------------------------------------------------------------------------------------------------------------
900.11(b)  5                   1                5                 .5               2.5      .......  ...........
 (3)
----------------------------------------------------------------------------------------------------------------
900.11(c)  9,200               0.04             368               5                1,840    .......  $1,000
----------------------------------------------------------------------------------------------------------------
900.12(c)  9,200               3,478            36,000,000        5 Minutes        3,000,0  .......  ...........
 (2)                                                                                00
----------------------------------------------------------------------------------------------------------------
900.12(j)  25                  1                25                1                25       .......  ...........
 (1)
----------------------------------------------------------------------------------------------------------------
900.12(j)  25                  0.08             2                 50               100      .......  ...........
 (2)
----------------------------------------------------------------------------------------------------------------
900.15(c)  9,200               0.05             46                2                92       .......  ...........
----------------------------------------------------------------------------------------------------------------
900.15(d)  9,200               0.0001           0.92              2                1.8      .......  $10
 (3)(ii)
----------------------------------------------------------------------------------------------------------------
900.18(c)  9,300               0.00032          3                 2                6        .......  $30
----------------------------------------------------------------------------------------------------------------
900.18(e)  10                  0.0100           0.1               1                0.1      .......  $10
----------------------------------------------------------------------------------------------------------------
FDA Form   800                 1                800               .25               200     .......  ...........
 3422
----------------------------------------------------------------------------------------------------------------
TOTAL      ..................  ...............  ................  ...............  3,095,7  $50      $1,040
                                                                                    16
----------------------------------------------------------------------------------------------------------------


                               Table 2.--Estimated Annual Recordkeeping Burden\1\
----------------------------------------------------------------------------------------------------------------
                                                                                                        Total
                                                                                                      Operating
 21 CFR         Number of         Annual Frequency of   Total Annual        Hours per        Total       and
 Section   [chyph]Recordkeepers  [chyph]Recordkeeping  [chyph]Records  [chyph]Recordkeeper   Hours   Maintenance
                                                                                                        Costs
----------------------------------------------------------------------------------------------------------------
900.3(f)  5                      0.02                  0.1             200                  20       ...........
 (1)
----------------------------------------------------------------------------------------------------------------
900.4(g)  1                      0.33                  0.33            1                    0.33     ...........
----------------------------------------------------------------------------------------------------------------
900.12(c  9,200                  1                     9,200           1                    9,200     $18,400
 )(4)
----------------------------------------------------------------------------------------------------------------
900.12(e  9,200                  52                    478,400         0.125                59,800   ...........
 )(13)
----------------------------------------------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------

    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 records under the initial and final mammography regulations.

    Dated: November 3, 2003.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 03-28006 Filed 11-6-03; 8:45 am]
BILLING CODE 4160-01-S