Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements, 18548-18551 [2019-08784]
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18548
Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Notices
** Mean
*** Mean
hourly wage for Medical Secretaries (43–6013).
hourly wage for Pharmacy Technicians (29–2052).
Occupational Employment Statistics,
May 2017 National Occupational
Employment and Wage Estimates
United States, U.S. Department of Labor,
Bureau of Labor Statistics.
Request for Comments
In accordance with the Paperwork
Reduction Act, comments on AHRQ’s
information collection are requested
with regard to any of the following: (a)
Whether the proposed collection of
information is necessary for the proper
performance of AHRQ’s health care
research and health care information
dissemination functions, including
whether the information will have
practical utility; (b) the accuracy of
AHRQ’s estimate of burden (including
hours and costs) of the proposed
collection(s) of information; (c) ways to
enhance the quality, utility and clarity
of the information to be collected; and
(d) ways to minimize the burden of the
collection of information upon the
respondents, including the use of
automated collection techniques or
other forms of information technology.
Comments submitted in response to
this notice will be summarized and
included in the Agency’s subsequent
request for OMB approval of the
proposed information collection. All
comments will become a matter of
public record.
Gopal Khanna,
Director.
[FR Doc. 2019–08765 Filed 4–30–19; 8:45 am]
BILLING CODE 4160–90–P
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.
The Food and Drug
Administration (FDA or Agency) 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
jbell on DSK30RV082PROD with NOTICES
SUMMARY:
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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 the estimated
reporting, recordkeeping, and thirdparty disclosure burden associated with
the Mammography Quality Standards
Act requirements.
DATES: Submit either electronic or
written comments on the collection of
information by July 1, 2019.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before July 1, 2019.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of July 1, 2019. Comments
received by mail/hand delivery/courier
(for written/paper submissions) will be
considered timely if they are
postmarked or the delivery service
acceptance receipt is on or before that
date.
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov 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 https://www.regulations.gov.
• 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
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
PO 00000
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• 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.
• 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 https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday.
• 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
https://www.regulations.gov. 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: https://www.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.pdf.
Docket: For access to the docket to
read background documents or the
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Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Notices
electronic and written/paper comments
received, go to https://
www.regulations.gov 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.
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, PRAStaff@
fda.hhs.gov.
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 (Pub. L. 102–539) 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 FDAapproved 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 (3) and
900.3(f)(1). 21 CFR 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 1 hour, it has been rounded
to 1 hour. All other ‘‘Total Hours’’ have
been rounded to the nearest whole
number.)
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
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Activity/21 CFR section/FDA Form No.
Notification of intent to become an AB—
900.3(b)(1).
Application for approval as an AB; full 2—
900.3(b)(3).
Application for approval as an AB; limited 3—900.3(b)(3).
AB renewal of approval—900.3(c) ................
AB application deficiencies—900.3(d)(2) ......
AB resubmission of denied applications—
900.3(d)(5).
Letter of intent to relinquish accreditation authority—900.3(e).
Summary report describing all facility assessments—900.4(f).
AB reporting to FDA; facility 4—900.4(h) ......
AB reporting to FDA; AB 5—900.4(h) ...........
AB financial records—900.4(i)(2) ..................
Former AB new application—900.6(c)(1) .....
Reconsideration of accreditation following
appeal—900.15(d)(3)(ii).
Application for alternative standard—
900.18(c).
Alternative standard amendment—900.18(e)
Certification agency application—900.21(b)
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Number of
respondents
Number of
responses
per respondent
Total annual
responses
Average burden
per response
Total hours 1
Total capital
costs
Total
operating and
maintenance
costs
0.33
1
0.33
1 .................................
1
0.33
1
0.33
320 .............................
106
5
1
5
30 ...............................
150
1
0.1
0.1
1
1
1
1
0.1
0.1
15 ...............................
30 ...............................
30 ...............................
15
3
3
0.1
1
0.1
1 .................................
1
330
1
330
7 .................................
2,310
......................
$83,618
8,654
5
1
0.1
1
1
1
1
1
1
8,654
5
1
0.1
1
1 .................................
10 ...............................
16 ...............................
60 ...............................
2 .................................
8,654
50
16
6
2
......................
4,663
2
1
2
2 .................................
4
10
0.33
1
1
10
0.33
1 .................................
320 .............................
10
106
32,327
224
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued
Number of
respondents
Activity/21 CFR section/FDA Form No.
Certification
agency
application
deficiencies—900.21(c)(2).
Certification electronic data transmission—
900.22(h).
Changes to standards—900.22(i) .................
Certification agency minor deficiencies—
900.24(b).
Appeal of adverse action taken by FDA—
900.25(a).
Inspection fee exemption—Form FDA 3422
Total .......................................................
Number of
responses
per respondent
Total annual
responses
Average burden
per response
Total hours 1
0.1
1
0.1
30 ...............................
3
5
200
1000
0.083 (5 minutes) ......
83
2
1
1
1
2
1
30 ...............................
30 ...............................
60
30
0.2
1
0.2
16 ...............................
3
700
1
700
0.25 (15 minutes) ......
175
......................
......................
......................
....................................
11,791
Total
operating and
maintenance
costs
Total capital
costs
......................
22
43,103
88,527
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
Number of
recordkeepers
Activity/21 CFR section
AB transfer of facility records—900.3(f)(1) ...
Consumer complaints system; AB—900.4(g)
Documentation of interpreting physician initial requirements—900.12(a)(1)(i)(B)(2).
Documentation of interpreting physician personnel requirements—900.12(a)(4).
Permanent medical record—900.12(c)(4) .....
Procedures for cleaning equipment—
900.12(e)(13).
Audit program—900.12(f) ..............................
Consumer complaints system; facility—
900.12(h)(2).
Certification agency conflict of interest—
900.22(a).
Processes for suspension and revocation of
certificates—900.22(d).
Processes for appeals—900.22(e) ...............
Processes for additional mammography review—900.22(f).
Processes
for
patient
notifications—
900.22(g).
Evaluation of certification agency—900.23 ...
Appeals—900.25(b) ......................................
Total .......................................................
1 Total
Number of
records per
recordkeeper
Total annual
records
Average burden
per recordkeeping
Total hours 1
0.1
5
87
1
1
1
0.1
5
87
0 .................................
1 .................................
8 .................................
1
5
696
8,654
4
34,616
1 .................................
34,616
8,654
8,654
1
52
8,654
450,008
1 .................................
0.083 (5 minutes) ......
8,654
37,351
8,654
8,654
1
2
8,654
17,308
16 ...............................
1 .................................
138,464
17,308
5
1
5
1 .................................
5
5
1
5
1 .................................
5
5
5
1
1
5
5
1 .................................
1 .................................
5
5
3
1
3
1 .................................
3
5
5
1
1
5
5
20 ...............................
1 .................................
100
5
......................
......................
......................
....................................
237,223
Total
operating and
maintenance
costs
Total capital
costs
$30,171
......................
$32
30,171
32
hours have been rounded.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
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Notification of facilities that AB relinquishes its accreditation—
900.3(f)(2).
Clinical images; facility 3—900.4(c),
900.11(b)(1), and 900.11(b)(2).
Clinical images; AB 4—900.4(c) .....
Phantom
images;
facility 3—
900.4(d),
900.11(b)(1),
and
900.11(b)(2).
Phantom images; AB 4—900.4(d) ..
Annual equipment evaluation and
survey;
facility 3—900.4(e),
900.11(b)(1), and 900.11(b)(2).
Annual equipment evaluation and
survey; AB 4—900.4(e).
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Number of
disclosures
per
respondent
Number of
respondents
Activity/21 CFR section
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Average
burden per
disclosure
Total annual
disclosures
Total hours 2
Total
operating and
maintenance
costs
0.1
1
0.1
200 ..........................
20
$54
2,885
1
2,885
1.44 .........................
4,154
248,670
5
2,885
1
1
5
2,885
416 ..........................
0.72 (43 minutes) ....
2,080
2,077
5
8,654
1
1
5
8,654
208 ..........................
1 ..............................
1,040
8,654
5
1
5
1,730 .......................
8,650
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Federal Register / Vol. 84, No. 84 / Wednesday, May 1, 2019 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
disclosures
per
respondent
Number of
respondents
Activity/21 CFR section
Provisional mammography facility
certificate extension application—900.11(b)(3).
Mammography facility certificate
reinstatement
application—
900.11(c).
Lay summary of examination—
900.12(c)(2).
Lay summary of examination; patient refusal 5—900.12(c)(2).
Report of unresolved serious complaints—900.12(h)(4).
Information regarding compromised
quality; facility 3—900.12(j)(1).
Information regarding compromised
quality; AB 4—900.12(j)(1).
Patient notification of serious risk—
900.12(j)(2).
Reconsideration of accreditation—
900.15(c).
Notification of requirement to correct
major
deficiencies—
900.24(a).
Notification of loss of approval;
major deficiencies—900.24(a)(2).
Notification of probationary status—900.24(b)(1).
Notification of loss of approval;
minor deficiencies—900.24(b)(3).
Total ........................................
Average
burden per
disclosure
Total annual
disclosures
Total hours 2
Total
operating and
maintenance
costs
0
1
0
0.5 (30 minutes) ......
1
312
1
312
5 ..............................
1,560
8,654
5,085
44,055,590
0.083 (5 minutes) ....
3,652,464
87
1
87
0.5 (30 minutes) ......
44
20
1
20
1 ..............................
20
20
1
20
200 ..........................
4,000
324
20
1
20
320 ..........................
6,400
646
5
1
5
100 ..........................
500
20,878
5
1
5
2 ..............................
10
0.4
1
0.4
200 ..........................
80
73
0.15
1
0.15
100 ..........................
15
27
0.3
1
0.3
200 ..........................
60
55
0.15
1
0.15
100 ..........................
15
27
........................
........................
........................
.................................
3,691,842
26,141,344
25,861,265
1 There
are no capital costs associated with the collection of information.
hours have been rounded.
to the facility component of the burden for this requirement.
4 Refers to the AB component of the burden for this requirement.
5 Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.
2 Total
3 Refers
FDA has adjusted the number of
respondents for § 900.3(c) ‘‘AB renewal
of approval’’ to one. This adjustment
resulted in a 14-hour increase to the
hour-burden estimate. Additionally, we
updated the capital costs and operating
and maintenance costs by adjusting
them for inflation since the last update
to those estimates. This adjustment
resulted in a $1,893,071 increase to the
estimated capital and operating and
maintenance costs ($24,410,106
previously; $26,303,177 current
extension request).
Dated: April 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–08784 Filed 4–30–19; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0559]
Agency Information Collection
Activities; Submission for Office of
Management and Budget Review;
Comment Request; Public Health
Service Guideline on Infectious
Disease Issues in Xenotransplantation
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) 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: Fax written comments on the
collection of information by May 31,
2019.
SUMMARY:
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To ensure that comments on
the information collection are received,
OMB recommends that written
comments be faxed to the Office of
Information and Regulatory Affairs,
OMB, Attn: FDA Desk Officer, Fax: 202–
395–7285, or emailed to oira_
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0456. Also
include the FDA docket number found
in brackets in the heading of this
document.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
JonnaLynn Capezzuto, Office of
Operations, Food and Drug
Administration, Three White Flint
North, 10A–12M, 11601 Landsdown St.,
North Bethesda, MD 20852, 301–796–
3794, PRAStaff@fda.hhs.gov.
In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
collection of information to OMB for
review and clearance.
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 84, Number 84 (Wednesday, May 1, 2019)]
[Notices]
[Pages 18548-18551]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-08784]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) 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 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 July 1, 2019.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before July 1, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of July 1, 2019. Comments received
by mail/hand delivery/courier (for written/paper submissions) will be
considered timely if they are postmarked or the delivery service
acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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 manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
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.
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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday.
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 https://www.regulations.gov.
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: https://www.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the
[[Page 18549]]
electronic and written/paper comments received, go to https://www.regulations.gov 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.
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,
[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 (Pub. L. 102-539) 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 (3) and 900.3(f)(1). 21 CFR 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 1 hour, it has been
rounded to 1 hour. All other ``Total Hours'' have been rounded to the
nearest whole number.)
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Total operating
Activity/21 CFR section/FDA Form No. Number of responses Total annual Average burden per response Total hours capital and
respondents per responses \1\ costs maintenance
respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of intent to become an 0.33 1 0.33 1............................. 1
AB--900.3(b)(1).
Application for approval as an AB; 0.33 1 0.33 320........................... 106 $10,776
full \2\--900.3(b)(3).
Application for approval as an AB; 5 1 5 30............................ 150
limited \3\--900.3(b)(3).
AB renewal of approval--900.3(c).... 1 1 1 15............................ 15
AB application deficiencies-- 0.1 1 0.1 30............................ 3
900.3(d)(2).
AB resubmission of denied 0.1 1 0.1 30............................ 3
applications--900.3(d)(5).
Letter of intent to relinquish 0.1 1 0.1 1............................. 1
accreditation authority--900.3(e).
Summary report describing all 330 1 330 7............................. 2,310 ............ $83,618
facility assessments--900.4(f).
AB reporting to FDA; facility \4\-- 8,654 1 8,654 1............................. 8,654 ............ 4,663
900.4(h).
AB reporting to FDA; AB \5\-- 5 1 5 10............................ 50
900.4(h).
AB financial records--900.4(i)(2)... 1 1 1 16............................ 16
Former AB new application-- 0.1 1 0.1 60............................ 6
900.6(c)(1).
Reconsideration of accreditation 1 1 1 2............................. 2
following appeal--900.15(d)(3)(ii).
Application for alternative 2 1 2 2............................. 4
standard--900.18(c).
Alternative standard amendment-- 10 1 10 1............................. 10
900.18(e).
Certification agency application-- 0.33 1 0.33 320........................... 106 32,327 224
900.21(b).
[[Page 18550]]
Certification agency application 0.1 1 0.1 30............................ 3
deficiencies--900.21(c)(2).
Certification electronic data 5 200 1000 0.083 (5 minutes)............. 83
transmission--900.22(h).
Changes to standards--900.22(i)..... 2 1 2 30............................ 60 ............ 22
Certification agency minor 1 1 1 30............................ 30
deficiencies--900.24(b).
Appeal of adverse action taken by 0.2 1 0.2 16............................ 3
FDA--900.25(a).
Inspection fee exemption--Form FDA 700 1 700 0.25 (15 minutes)............. 175
3422.
-------------------------------------------------------------------------------------------------------------------
Total........................... ............ ............ ............ .............................. 11,791 43,103 88,527
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Total operating
Activity/21 CFR section Number of records per Total annual Average burden per Total hours capital and
recordkeepers recordkeeper records recordkeeping \1\ costs maintenance
costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
AB transfer of facility records-- 0.1 1 0.1 0............................. 1
900.3(f)(1).
Consumer complaints system; AB-- 5 1 5 1............................. 5
900.4(g).
Documentation of interpreting 87 1 87 8............................. 696
physician initial requirements--
900.12(a)(1)(i)(B)(2).
Documentation of interpreting 8,654 4 34,616 1............................. 34,616
physician personnel requirements--
900.12(a)(4).
Permanent medical record-- 8,654 1 8,654 1............................. 8,654 $30,171
900.12(c)(4).
Procedures for cleaning equipment-- 8,654 52 450,008 0.083 (5 minutes)............. 37,351
900.12(e)(13).
Audit program--900.12(f)........... 8,654 1 8,654 16............................ 138,464
Consumer complaints system; 8,654 2 17,308 1............................. 17,308
facility--900.12(h)(2).
Certification agency conflict of 5 1 5 1............................. 5
interest--900.22(a).
Processes for suspension and 5 1 5 1............................. 5
revocation of certificates--
900.22(d).
Processes for appeals--900.22(e)... 5 1 5 1............................. 5
Processes for additional 5 1 5 1............................. 5
mammography review--900.22(f).
Processes for patient 3 1 3 1............................. 3 ............ $32
notifications--900.22(g).
Evaluation of certification agency-- 5 1 5 20............................ 100
900.23.
Appeals--900.25(b)................. 5 1 5 1............................. 5
--------------------------------------------------------------------------------------------------------------------
Total.......................... ............. ............ ............ .............................. 237,223 30,171 32
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total hours have been rounded.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Total hours operating and
Activity/21 CFR section respondents disclosures disclosures Average burden per disclosure \2\ maintenance
per respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of facilities that AB 0.1 1 0.1 200.............................. 20 $54
relinquishes its accreditation--
900.3(f)(2).
Clinical images; facility \3\-- 2,885 1 2,885 1.44............................. 4,154 248,670
900.4(c), 900.11(b)(1), and
900.11(b)(2).
Clinical images; AB \4\--900.4(c).... 5 1 5 416.............................. 2,080
Phantom images; facility \3\-- 2,885 1 2,885 0.72 (43 minutes)................ 2,077
900.4(d), 900.11(b)(1), and
900.11(b)(2).
Phantom images; AB \4\--900.4(d)..... 5 1 5 208.............................. 1,040
Annual equipment evaluation and 8,654 1 8,654 1................................ 8,654 9,325
survey; facility \3\--900.4(e),
900.11(b)(1), and 900.11(b)(2).
Annual equipment evaluation and 5 1 5 1,730............................ 8,650
survey; AB \4\--900.4(e).
[[Page 18551]]
Provisional mammography facility 0 1 0 0.5 (30 minutes)................. 1
certificate extension application--
900.11(b)(3).
Mammography facility certificate 312 1 312 5................................ 1,560
reinstatement application--900.11(c).
Lay summary of examination-- 8,654 5,085 44,055,590 0.083 (5 minutes)................ 3,652,464 25,861,265
900.12(c)(2).
Lay summary of examination; patient 87 1 87 0.5 (30 minutes)................. 44
refusal \5\--900.12(c)(2).
Report of unresolved serious 20 1 20 1................................ 20
complaints--900.12(h)(4).
Information regarding compromised 20 1 20 200.............................. 4,000 324
quality; facility \3\--900.12(j)(1).
Information regarding compromised 20 1 20 320.............................. 6,400 646
quality; AB \4\--900.12(j)(1).
Patient notification of serious risk-- 5 1 5 100.............................. 500 20,878
900.12(j)(2).
Reconsideration of accreditation-- 5 1 5 2................................ 10
900.15(c).
Notification of requirement to 0.4 1 0.4 200.............................. 80 73
correct major deficiencies--
900.24(a).
Notification of loss of approval; 0.15 1 0.15 100.............................. 15 27
major deficiencies--900.24(a)(2).
Notification of probationary status-- 0.3 1 0.3 200.............................. 60 55
900.24(b)(1).
Notification of loss of approval; 0.15 1 0.15 100.............................. 15 27
minor deficiencies--900.24(b)(3).
------------------------------------------------------------------------------------------------------------------
Total............................ .............. .............. .............. ................................. 3,691,842 26,141,344
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs associated with the collection of information.
\2\ Total hours have been rounded.
\3\ Refers to the facility component of the burden for this requirement.
\4\ Refers to the AB component of the burden for this requirement.
\5\ Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.
FDA has adjusted the number of respondents for Sec. 900.3(c) ``AB
renewal of approval'' to one. This adjustment resulted in a 14-hour
increase to the hour-burden estimate. Additionally, we updated the
capital costs and operating and maintenance costs by adjusting them for
inflation since the last update to those estimates. This adjustment
resulted in a $1,893,071 increase to the estimated capital and
operating and maintenance costs ($24,410,106 previously; $26,303,177
current extension request).
Dated: April 24, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-08784 Filed 4-30-19; 8:45 am]
BILLING CODE 4164-01-P
