[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Pages 13681-13684]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-04677]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0134]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Mammography Quality Standards Act Requirements
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 collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on
[[Page 13682]]
the estimated reporting, recordkeeping, and third-party disclosure
burden associated with the Mammography Quality Standards Act
requirements.
DATES: Submit either electronic or written comments on the collection
of information by April 29, 2013.
ADDRESSES: Submit electronic comments on the collection of information
to http://www.regulations.gov. 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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
[email protected].
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 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 Quality Standards Act Requirements--21 CFR Part 900 (OMB
Control Number 0910-0309)--Extension
The Mammography Quality Standards Act requires the establishment of
a Federal certification and inspection program for mammography
facilities; regulations and standards for accreditation and
certification bodies for mammography facilities; and standards for
mammography equipment, personnel, and practices, including quality
assurance. The intent of these regulations is to assure safe, reliable,
and accurate mammography on a nationwide level. Under the regulations,
as a first step in becoming certified, mammography facilities must
become accredited by an FDA-approved accreditation body (AB). This
requires undergoing a review of their clinical images and providing the
AB with information showing that they meet the equipment, personnel,
quality assurance and quality control standards, and have a medical
reporting and recordkeeping program, a medical outcomes audit program,
and a consumer complaint mechanism. On the basis of this accreditation,
facilities are then certified by FDA or an FDA-approved State
certification agency and must prominently display their certificate.
These actions are taken to ensure safe, accurate, and reliable
mammography on a nationwide basis.
The following sections of Title 21 of the Code of Federal
Regulations (CFR) are not included in the burden tables because they
are considered usual and customary practice and were part of the
standard of care prior to the implementation of the regulations.
Therefore, they resulted in no additional burden: 21 CFR 900.12(c)(1)
and (c)(3) and 21 CFR 900.3(f)(1). Section 900.24(c) was also not
included in the burden tables because if a certifying State had its
approval withdrawn, FDA would take over certifying authority for the
affected facilities. Because FDA already has all the certifying State's
electronic records, there wouldn't be an additional reporting burden.
We have rounded numbers in the ``Total Hours'' column in all three
burden tables. (Where the number was a portion of one hour, it has been
rounded to 1 hour. All other ``Total Hours'' have been rounded to the
nearest whole number.)
We do not expect any respondents for Sec. 900.3(c) because all
four ABs are approved until April 2020.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Number of Total
Number of responses Total Average Total hours Total operating &
Activity/21 CFR Section/FDA Form No. respondents per annual burden per \1\ capital maintenance
respondent responses response costs costs
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Notification of intent to become an AB--900.3(b)(1)......... 0.33 1 0.33 1 1 ........... ...........
Application for approval as an AB; full \2\--900.3(b)(3).... 0.33 1 0.33 320 106 $10,000 ...........
Application for approval as an AB; limited \3\--900.3(b)(3). 5 1 5 30 150 ........... ...........
AB renewal of approval--900.3(c)............................ 0 1 0 15 1 ........... ...........
AB application deficiencies--900.3(d)(2).................... 0.1 1 0.1 30 3 ........... ...........
AB resubmission of denied applications--900.3(d)(5)......... 0.1 1 0.1 30 3 ........... ...........
Letter of intent to relinquish accreditation authority-- 0.1 1 0.1 1 1 ........... ...........
900.3(e)...................................................
Summary report describing all facility assessments--900.4(f) 330 1 330 7 2,310 ........... $77,600
AB reporting to FDA; facility \4\--900.4(h)................. 8,654 1 8,654 1 8,654 ........... 4,327
AB reporting to FDA; AB \5\--900.4(h)....................... 5 1 5 10 50 ........... ...........
AB financial records--900.4(i)(2)........................... 1 1 1 16 16 ........... ...........
[[Page 13683]]
Former AB new application--900.6(c)(1)...................... 0.1 1 0.1 60 6 ........... ...........
Reconsideration of accreditation following appeal-- 1 1 1 2 2 ........... ...........
900.15(d)(3)(ii)...........................................
Application for alternative standard--900.18(c)............. 2 1 2 2 4 ........... ...........
Alternative standard amendment--900.18(e)................... 10 1 10 1 10 ........... ...........
Certification agency application--900.21(b)................. 0.33 1 0.33 320 106 ........... $208
Certification agency application deficiencies--900.21(c)(2). 0.1 1 0.1 30 3 ........... ...........
Certification electronic data transmission--900.22(h)....... 5 200 1000 0.083 83 $30,000 ...........
Changes to standards--900.22(i)............................. 2 1 2 30 60 ........... $20
Certification agency minor deficiencies--900.24(b).......... 1 1 1 30 30 ........... ...........
Appeal of adverse action taken by FDA--900.25(a)............ 0.2 1 0.2 16 3 ........... ...........
Inspection fee exemption--FDA Form 3422..................... 700 1 700 0.25 175 ........... ...........
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Total................................................... ............ ........... ........... ........... 11,777 40,000 82,155
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\1\ Total hours have been rounded.
\2\ One time burden.
\3\ Refers to accreditation bodies applying to accredit specific full-field digital mammography units.
\4\ Refers to the facility component of the burden for this requirement.
\5\ Refers to the AB component of the burden for this requirement.
Table 2--Estimated Annual Recordkeeping Burden
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Total
No. of Total Average Total operating
Activity/21 CFR Section No. of records per annual burden per Total hours capital and
recordkeepers recordkeeper records recordkeeping \1\ costs maintenance
costs
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AB transfer of facility records--900.3(f)(1)............. 0.1 1 0.1 0 1 ........... ...........
Consumer complaints system; AB--900.4(g)................. 5 1 5 1 5 ........... ...........
Documentation of interpreting physician initial 87 1 87 8 696 ........... ...........
requirements--900.12(a)(1)(i)(B)(2).....................
Documentation of interpreting physician personnel 8,654 4 34,616 1 34,616 ........... ...........
requirements--900.12(a)(4)..............................
Permanent medical record--900.12(c)(4)................... 8,654 1 8,654 1 8,654 $28,000 ...........
Procedures for cleaning equipment--900.12(e)(13)......... 8,654 52 450,008 0.083 37,351 ........... ...........
Audit program--900.12(f)................................. 8,654 1 8,654 16 138,464 ........... ...........
Consumer complaints system; facility--900.12(h)(2)....... 8,654 2 17,308 1 17,308 ........... ...........
Certification agency conflict of interest--900.22(a)..... 5 1 5 1 5 ........... ...........
Processes for suspension and revocation of certificates-- 5 1 5 1 5 ........... ...........
900.22(d)...............................................
Processes for appeals--900.22(e)......................... 5 1 5 1 5 ........... ...........
Processes for additional mammography review--900.22(f)... 5 1 5 1 5 ........... ...........
Processes for patient notifications--900.22(g)........... 3 1 3 1 3 ........... $30
Evaluation of certification agency--900.23............... 5 1 5 20 100 ........... ...........
Appeals--900.25(b)....................................... 5 1 5 1 5 ........... ...........
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Total................................................ ............. ............ .......... ............. 237,223 28,000 30
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\1\ Total hours have been rounded.
[[Page 13684]]
Table 3--Estimated Annual Third-Party Disclosures \1\
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Number of Total
Number of disclosures Total annual Average Total hours operating and
Activity/21 CFR Section respondents per disclosures burden per \2\ maintenance
respondent disclosure costs
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Notification of facilities that AB relinquishes its accreditation-- 0.1 1 0.1 200 20 $50
900.3(f)(2).......................................................
Clinical images; facility \2\--900.4(c), 900.11(b)(1), and 2,885 1 2,885 1.44 4,154 ..............
900.11(b)(2)......................................................
Clinical images; AB \3\--900.4(c).................................. 5 1 5 416 2,080 230,773
Phantom images; facility \2\--900.4(d), 900.11(b)(1), and 2,885 1 2,885 0.72 2,077 ..............
900.11(b)(2)......................................................
Phantom images; AB \3\--900.4(d)................................... 5 1 5 208 1,040 ..............
Annual equipment evaluation and survey; facility \2\--900.4(e), 8,654 1 8,654 1 8,654 8,654
900.11(b)(1), and 900.11(b)(2)....................................
Annual equipment evaluation and survey; AB \3\--900.4(e)........... 5 1 5 1,730 8,650 ..............
Provisional mammography facility certificate extension application-- 0 1 0 0.5 1 ..............
900.11(b)(3)......................................................
Mammography facility certificate reinstatement application-- 312 1 312 5 1,560 24,000,000
900.11(c).........................................................
Lay summary of examination--900.12(c)(2)........................... 8,654 5,085 44,005,590 0.083 3,652,464 ..............
Lay summary of examination; patient refusal \4\--900.12(c)(2)...... 87 1 87 0.5 44 ..............
Report of unresolved serious complaints--900.12(h)(4).............. 20 1 20 1 20 ..............
Information regarding compromised quality; facility \2\-- 20 1 20 200 4,000 300
900.12(j)(1)......................................................
Information regarding compromised quality; AB \3\--900.12(j)(1).... 20 1 20 320 6,400 600
Patient notification of serious risk--900.12(j)(2)................. 5 1 5 100 500 19,375
Reconsideration of accreditation--900.15(c)........................ 5 1 5 2 10 ..............
Notification of requirement to correct major deficiencies-- 0.4 1 0.4 200 80 68
900.24(a).........................................................
Notification of loss of approval; major deficiencies--900.24(a)(2). 0.15 1 0.15 100 15 25.50
Notification of probationary status--900.24(b)(1).................. 0.3 1 0.3 200 60 51
Notification of loss of approval; minor deficiencies--900.24(b)(3). 0.15 1 0.15 100 15 25.50
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Total.......................................................... ............ ........... .............. ........... 3,691,842 24,259,921
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\1\ There are no capital costs associated with this collection of information.
\2\ Total hours have been rounded.
Dated: February 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04677 Filed 2-27-13; 8:45 am]
BILLING CODE 4160-01-P