[Federal Register: November 7, 2003 (Volume 68, Number 216)]
[Notices]
[Page 63106-63108]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr07no03-81]
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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.
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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
[[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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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\
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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
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900.3 1 0.33 0.33 60 20 ....... ...........
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900.3(b)( 1 0.33 0.33 60 20 $50 ...........
3)
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900.3(c) 5 0.33 1.67 15 25 ....... ...........
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900.3(e) 1 0.1 0.1 1 0.1 ....... ...........
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900.3(f)( 1 0.1 0.1 200 20 ....... ...........
2)
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900.4(c) 9,200 0.33 3,067 1 3,067 ....... ...........
and (d)
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900.4(e) 9,450 1 9,450 8 75,600 ....... ...........
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900.4(f) 276 1 276 7 1,932 ....... ...........
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900.4(h) 5 1 6,130 1 6,130 ....... ...........
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900.4(i)( 1 0.33 0.33 1 0.33 ....... ...........
2)
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[[Page 63108]]
900.6(c)( 1 0.1 0.1 1 0.1 ....... ...........
1)
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900.11(b) 9,200 0.33 3,067 2 6,134 ....... ...........
(1)
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900.11(b) 250 1 250 2 500 ....... ...........
(2)
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900.11(b) 5 1 5 .5 2.5 ....... ...........
(3)
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900.11(c) 9,200 0.04 368 5 1,840 ....... $1,000
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900.12(c) 9,200 3,478 36,000,000 5 Minutes 3,000,0 ....... ...........
(2) 00
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900.12(j) 25 1 25 1 25 ....... ...........
(1)
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900.12(j) 25 0.08 2 50 100 ....... ...........
(2)
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900.15(c) 9,200 0.05 46 2 92 ....... ...........
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900.15(d) 9,200 0.0001 0.92 2 1.8 ....... $10
(3)(ii)
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900.18(c) 9,300 0.00032 3 2 6 ....... $30
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900.18(e) 10 0.0100 0.1 1 0.1 ....... $10
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FDA Form 800 1 800 .25 200 ....... ...........
3422
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TOTAL .................. ............... ................ ............... 3,095,7 $50 $1,040
16
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Table 2.--Estimated Annual Recordkeeping Burden\1\
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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)
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900.4(g) 1 0.33 0.33 1 0.33 ...........
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900.12(c 9,200 1 9,200 1 9,200 $18,400
)(4)
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900.12(e 9,200 52 478,400 0.125 59,800 ...........
)(13)
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900.12(f 9,200 1 9,200 5 46,000 ...........
)
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900.12(h 9,200 2 18,400 0.5 9,200 ...........
)
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TOTAL ..................... .................... .............. ................... 124,220 $18,400
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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