Notice2022-23028
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
October 24, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or we) 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.
Full Text
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<title>Federal Register, Volume 87 Issue 204 (Monday, October 24, 2022)</title>
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[Federal Register Volume 87, Number 204 (Monday, October 24, 2022)]
[Notices]
[Pages 64232-64234]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-23028]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2013-N-0134]
Agency Information Collection Activities; Submission for Office
of Management and Budget Review; 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 or we) 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: Submit written comments (including recommendations) on the
collection of information by November 23, 2022.
ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0309. Also include the FDA docket
number found in brackets in the heading of this document.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
<a href="/cdn-cgi/l/email-protection#9dcdcfdccee9fcfbfbddfbf9fcb3f5f5eeb3faf2eb"><span class="__cf_email__" data-cfemail="1b4b495a486f7a7d7d5b7d7f7a35737368357c746d">[email protected]</span></a>.
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.
Mammography Quality Standards Act Requirements--21 CFR Part 900
OMB Control Number 0910-0309--Extension
The Mammography Quality Standards Act (Pub. L. 102-539) requires
the establishment of a Federal certification and inspection program for
mammography facilities; standards for accreditation and certification
bodies for mammography facilities; and standards for mammography
equipment, personnel, and practices, including quality assurance.
Implementing regulations are found in part 900 (21 CFR part 900). The
regulations are intended 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.
FDA meets with its National Mammography Quality Assurance Advisory
Committee (NMQAAC) for the purposes of advising FDA's mammography
program on advances in mammography technology and procedures and on
appropriate quality standards for mammography facilities. NMQAAC is
made up of representatives of the mammography community, consumer and
industry groups, and government. The meetings are open to the public
and time is allotted for public statements on issues of concern in the
mammography field. The chairperson may also call upon attendees to
contribute to the committee discussions.
FDA also regularly meets or holds teleconferences with its approved
accreditation bodies and State certification agencies to discuss issues
of mutual concern. We also engage with the Conference of State
Radiation Program Directors (CRCPD), a professional organization of
State agencies concerned with radiation protection. The CRCPD has
established a standing Mammography Committee, which meets with FDA
mammography staff at least once a year.
Finally, in recent years, FDA mammography staff have met several
times with representatives of manufacturers working on the new
applications of digital technology in mammography to resolve problems
preventing the making of that technology generally available. FDA
mammography staff have also worked with representatives of the
manufacturers to develop quality assurance manuals for full field
digital mammography units.
[[Page 64233]]
In the Federal Register of August 8, 2022 (87 FR 48678), we
published a notice soliciting public comment of the proposed
information collection. No comments were received.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
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Number of
Activity/21 CFR section/FDA form No. Number of responses per Total annual Average burden per response Total hours
respondents respondent responses \1\
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Notification of intent to become an AB-- 0.33 1 0.33 1....................................... 1
900.3(b)(1).
Application for approval as an AB; full \2\-- 0.33 1 0.33 320..................................... 106
900.3(b)(3).
Application for approval as an AB; limited 5 1 5 30...................................... 150
\3\--900.3(b)(3).
AB renewal of approval--900.3(c).............. 1 1 1 15...................................... 15
AB application deficiencies--900.3(d)(2)...... 0.1 1 0.1 30...................................... 3
AB resubmission of denied applications-- 0.1 1 0.1 30...................................... 3
900.3(d)(5).
Letter of intent to relinquish accreditation 0.1 1 0.1 1....................................... 1
authority--900.3(e).
Summary report describing all facility 330 1 330 7....................................... 2,310
assessments--900.4(f).
AB reporting to FDA; facility \4\--900.4(h)... 8,718 1 8,718 1....................................... 8,718
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
Former AB new application--900.6(c)(1)........ 0.1 1 0.1 60...................................... 6
Reconsideration of accreditation following 1 1 1 2....................................... 2
appeal--900.15(d)(3)(ii).
Application for alternative standard-- 2 1 2 2....................................... 4
900.18(c).
Alternative standard amendment--900.18(e)..... 10 1 10 1....................................... 10
Certification agency application--900.21(b)... 0.33 1 0.33 320..................................... 106
Certification agency application deficiencies-- 0.1 1 0.1 30...................................... 3
900.21(c)(2).
Certification electronic data transmission-- 5 200 1,000 0.083 (5 minutes)....................... 83
900.22(h).
Changes to standards--900.22(i)............... 2 1 2 30...................................... 60
Certification agency minor deficiencies-- 1 1 1 30...................................... 30
900.24(b).
Appeal of adverse action taken by FDA-- 0.2 1 0.2 16...................................... 3
900.25(a).
Inspection fee exemption--FDA Form 3422....... 419 1 419 0.25 (15 minutes)....................... 105
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Total..................................... .............. .............. .............. ........................................ 11,785
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\1\ Numbers 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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Number of
Activity/21 CFR section Number of records per Total annual Average burden per recordkeeping Total hours
recordkeepers recordkeeper records \1\
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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 87 1 87 8....................................... 696
initial requirements--900.12(a)(1)(i)(B)(2).
Documentation of interpreting physician 8,718 4 34,872 1....................................... 34,872
personnel requirements--900.12(a)(4).
Permanent medical record--900.12(c)(4)........ 8,718 1 8,718 1....................................... 8,718
Procedures for cleaning equipment-- 8,718 52 453,336 0.083 (5 minutes)....................... 37,627
900.12(e)(13).
Audit program--900.12(f)...................... 8,718 1 8,718 16...................................... 139,488
Consumer complaints system; facility-- 8,718 2 17,436 1....................................... 17,436
900.12(h)(2).
Certification agency conflict of interest-- 5 1 5 1....................................... 5
900.22(a).
Processes for suspension and revocation of 5 1 5 1....................................... 5
certificates--900.22(d).
Processes for appeals--900.22(e).............. 5 1 5 1....................................... 5
Processes for additional mammography review-- 5 1 5 1....................................... 5
900.22(f).
Processes for patient notifications--900.22(g) 3 1 3 1....................................... 3
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..................................... .............. .............. .............. ........................................ 238,971
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\1\ Total hours have been rounded.
[[Page 64234]]
Table 3--Estimated Annual Third-Party Disclosure Burden
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Number of
Activity/21 CFR section Number of disclosures Total annual Average burden per disclosure Total hours
respondents per respondent disclosures \1\
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Notification of facilities that AB 0.1 1 0.1 200..................................... 20
relinquishes its accreditation--900.3(f)(2).
Clinical images; facility \2\--900.4(c), 2,885 1 2,885 1.44.................................... 4,154
900.11(b)(1), and 900.11(b)(2).
Clinical images; AB \3\--900.4(c)............. 5 1 5 416..................................... 2,080
Phantom images; facility \2\--900.4(d), 2,885 1 2,885 0.72 (43 minutes)....................... 2,077
900.11(b)(1), and 900.11(b)(2).
Phantom images; AB \3\--900.4(d).............. 5 1 5 208..................................... 1,040
Annual equipment evaluation and survey; 8,718 1 8,718 1....................................... 8,718
facility \2\--900.4(e), 900.11(b)(1), and
900.11(b)(2).
Annual equipment evaluation and survey; AB 5 1 5 1,730................................... 8,650
\3\--900.4(e).
Provisional mammography facility certificate 0 1 0 0.5 (30 minutes)........................ 1
extension application--900.11(b)(3).
Mammography facility certificate reinstatement 281 1 281 5....................................... 1,405
application--900.11(c).
Lay summary of examination--900.12(c)(2)...... 8,718 5,085 44,331,030 0.083 (5 minutes)....................... 3,679,475
Lay summary of examination; patient refusal 87 1 87 0.5 (30 minutes)........................ 44
\4\--900.12(c)(2).
Report of unresolved serious complaints-- 20 1 20 1....................................... 20
900.12(h)(4).
Information regarding compromised quality; 20 1 20 200..................................... 4,000
facility \2\--900.12(j)(1).
Information regarding compromised quality; AB 20 1 20 320..................................... 6,400
\3\--900.12(j)(1).
Patient notification of serious risk-- 5 1 5 100..................................... 500
900.12(j)(2).
Reconsideration of accreditation--900.15(c)... 5 1 5 2....................................... 10
Notification of requirement to correct major 0.4 1 0.4 200..................................... 80
deficiencies--900.24(a).
Notification of loss of approval; major 0.15 1 0.15 100..................................... 15
deficiencies--900.24(a)(2).
Notification of probationary status-- 0.3 1 0.3 200..................................... 60
900.24(b)(1).
Notification of loss of approval; minor 0.15 1 0.15 100..................................... 15
deficiencies--900.24(b)(3).
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Total..................................... .............. .............. .............. ........................................ 3,718,764
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\1\ Total hours have been rounded.
\2\ Refers to the facility component of the burden for this requirement.
\3\ Refers to the AB component of the burden for this requirement.
\4\ Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.
Respondents use the Mammography Program Reporting and Information
System to submit information. Our estimated burden for the information
collection reflects an overall increase of 28,664 hours and a
corresponding increase of 9,137,449 responses/records. We attribute
this adjustment to an increase in the number of submissions we received
over the last few years. We do not include burden for Sec. Sec.
900.12(c)(1) and (3), 900.3(f)(1), and 900.24(c) 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, we assume no
additional reporting burden.
Dated: October 18, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-23028 Filed 10-21-22; 8:45 am]
BILLING CODE 4164-01-P
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