Notice2022-17151
Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements
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Published
August 10, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA, Agency, or we) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 information collection associated with the Mammography Quality Standards Act.
Full Text
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<title>Federal Register, Volume 87 Issue 153 (Wednesday, August 10, 2022)</title>
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[Federal Register Volume 87, Number 153 (Wednesday, August 10, 2022)]
[Notices]
[Pages 48678-48681]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17151]
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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, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (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 information collection
associated with the Mammography Quality Standards Act.
DATES: Either electronic or written comments on the collection of
information must be submitted by October 11, 2022.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of October 11, 2022. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the
[[Page 48679]]
manner detailed (see ``Written/Paper Submissions'' and
``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0134 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Mammography Quality Standards Act
Requirements.'' Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-8867,
<a href="/cdn-cgi/l/email-protection#ecbcbeadbf988d8a8aac8a888dc284849fc28b839a"><span class="__cf_email__" data-cfemail="edbdbfacbe998c8b8bad8b898cc385859ec38a829b">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), 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 (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,
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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.
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 \3\-- 5 1 5 30..................................... 150
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--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
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 initial 87 1 87 8...................................... 696
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.
Table 3--Estimated Annual Third-Party Disclosure Burden
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Number of
Number of disclosures Total annual Total hours
Activity/21 CFR section respondents per disclosures Average burden per disclosure \1\
respondent
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Notification of facilities that AB relinquishes 0.1 1 0.1 200.................................... 20
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 \3\-- 5 1 5 1,730.................................. 8,650
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: August 4, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17151 Filed 8-9-22; 8:45 am]
BILLING CODE 4164-01-P
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