Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements, 55463-55466 [2016-19808]
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55463
Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices
(21 U.S.C. 381(e)(2)) provides for the
exportation of an unapproved device
under certain circumstances if the
exportation is not contrary to the public
health and safety and it has the approval
of the foreign country to which it is
intended for export. Requesters
communicate (either directly or through
a business associate in the foreign
country) with a representative of the
foreign government to which they seek
exportation, and written authorization
must be obtained from the appropriate
office within the foreign government
approving the importation of the
medical device. An alternative to
obtaining written authorization from the
foreign government is to accept a
notarized certification from a
responsible company official in the
United States that the product is not in
conflict with the foreign country’s laws.
This certification must include a
statement acknowledging that the
responsible company official making the
certification is subject to the provisions
of 18 U.S.C. 1001. This statutory
provision makes it a criminal offense to
knowingly and willingly make a false or
fraudulent statement, or make or use a
false document, in any manner within
the jurisdiction of a department or
Agency of the United States. The
respondents to this collection of
information are companies that seek to
export medical devices. FDA’s estimate
of the reporting burden is based on the
experience of FDA’s medical device
program personnel.
In the Federal Register of April 22,
2016 (81 FR 23720), FDA published a
60-day notice requesting public
comment on the proposed collection of
information. No comments were
received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Activity/Section of FD&C Act
Number of
respondents
Number of
responses
per
respondent
Total annual
responses
Average
burden per
response
Total hours
Total operating and
maintenance
costs
Foreign letter of approval—section 801(e)(2) ........
38
1
38
3
114
$9,500
1 There
are no capital costs associated with this collection of information.
Dated: August 15, 2016.
Peter Lurie,
Associate Commissioner for Public Health
Strategy and Analysis.
submission@omb.eop.gov. All
comments should be identified with the
OMB control number 0910–0309. Also
include the FDA docket number found
in brackets in the heading of this
document.
FOR FURTHER INFORMATION CONTACT: FDA
PRA Staff, Office of Operations, Food
and Drug Administration, Three White
Flint North,10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, PRAStaff@fda.hhs.gov.
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.
[FR Doc. 2016–19807 Filed 8–18–16; 8:45 am]
BILLING CODE 4164–01–P
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.
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 September
19, 2016.
ADDRESSES: 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_
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
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Jkt 238001
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
PO 00000
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Fmt 4703
Sfmt 4703
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). 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 1 hour, it has been rounded
to 1 hour. All other ‘‘Total Hours’’ have
been rounded to the nearest whole
number.)
E:\FR\FM\19AUN1.SGM
19AUN1
55464
Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices
We do not expect any respondents for
§ 900.3(c) because all four ABs are
approved until April 2020.
In the Federal Register of June 8, 2016
(81 FR 36924), FDA published a 60-day
notice requesting public comment on
the proposed collection of information.
No comments were received.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Activity/21 CFR Section/Form
FDA 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) .......................
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
Number of
respondents
Total annual
responses
Average
burden per
response
Total capital
costs
(in dollars)
Total
hours 1
Total operating
and
maintenance
costs
(in dollars)
0.33
1
0.33
1
1
....................
........................
0.33
1
0.33
320
106
10,000
........................
5
1
5
30
150
....................
........................
0
1
0
15
1
....................
........................
0.1
1
0.1
30
3
....................
........................
0.1
1
0.1
30
3
....................
........................
0.1
1
0.1
1
1
....................
........................
330
1
330
7
2,310
....................
77,600
8,654
1
8,654
1
8,654
....................
4,327
5
1
1
1
5
1
10
16
50
16
....................
....................
........................
........................
0.1
1
0.1
60
6
....................
........................
1
1
1
2
2
....................
........................
2
1
2
2
4
....................
........................
10
1
10
1
10
....................
........................
0.33
1
0.33
320
106
....................
208
0.1
1
0.1
30
3
....................
........................
83
30,000
........................
5
200
1000
2
1
2
30
60
....................
20
1
1
1
30
30
....................
........................
0.2
1
0.2
16
3
....................
........................
175
....................
........................
11,777
40,000
82,155
700
......................
1
......................
0.083
700
0.25
......................
........................
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.
mstockstill on DSK3G9T082PROD with NOTICES
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Activity/21 CFR Section
Number of
recordkeepers
AB transfer of facility
records—900.3(f)(1)
VerDate Sep<11>2014
18:08 Aug 18, 2016
Number of
records per
recordkeeper
0.1
Jkt 238001
Total annual
records
1
PO 00000
Frm 00037
Average
burden per
recordkeeping
0.1
Fmt 4703
Sfmt 4703
Total hours 1
0
E:\FR\FM\19AUN1.SGM
1
19AUN1
Total capital
costs
(in dollars)
Total operating
and
maintenance
costs
(in dollars)
........................
........................
55465
Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued
Activity/21 CFR Section
Number of
recordkeepers
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
Average
burden per
recordkeeping
Total annual
records
Total capital
costs
(in dollars)
Total hours 1
Total operating
and
maintenance
costs
(in dollars)
5
1
5
1
5
........................
........................
87
1
87
8
696
........................
........................
8,654
4
34,616
1
34,616
........................
........................
8,654
1
8,654
1
8,654
28,000
........................
8,654
52
450,008
37,351
........................
........................
8,654
1
8,654
16
138,464
........................
........................
8,654
2
17,308
1
17,308
........................
........................
5
1
5
1
5
........................
........................
5
1
5
1
5
........................
........................
5
1
5
1
5
........................
........................
5
1
5
1
5
........................
........................
3
1
3
1
3
........................
30
5
5
1
1
5
5
20
1
100
5
........................
........................
........................
........................
237,223
28,000
30
........................
........................
0.083
........................
........................
hours have been rounded.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1
Number of
respondents
mstockstill on DSK3G9T082PROD with NOTICES
Activity/21 CFR Section
Notification of facilities that AB relinquishes its accreditation—900.3(f)(2) ..
Clinical
images;
facility 3—900.4(c),
900.11(b)(1) and (2) .............................
Clinical images; AB 4—900.4(c) ...............
Phantom images; facility 3—900.4(d),
900.11(b)(1) and (2) .............................
Phantom images; AB 4—900.4(d) ............
Annual equipment evaluation and survey;
facility 3—900.4(e), 900.11(b)(1) and
(2) .........................................................
Annual equipment evaluation and survey;
AB 4—900.4(e) ......................................
Provisional mammography facility certificate
extension
application—
900.11(b)(3) ..........................................
VerDate Sep<11>2014
18:08 Aug 18, 2016
Jkt 238001
Number of
disclosures per
respondent
Total annual
disclosures
0.1
1
0.1
Average
burden per
disclosure
200
Total hours 2
Total operating
and
maintenance
costs
(in dollars)
20
50
2,885
5
1
1
2,885
5
1.44
416
4,154
2,080
........................
230,773
2,885
5
1
1
2,885
5
0.72
208
2,077
1,040
........................
........................
8,654
1
8,654
1
8,654
8,654
5
1
5
1,730
8,650
........................
0
1
0
1
........................
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E:\FR\FM\19AUN1.SGM
0.5
19AUN1
55466
Federal Register / Vol. 81, No. 161 / Friday, August 19, 2016 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Number of
respondents
Activity/21 CFR Section
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 ..................................................
1
2
3
4
5
Average
burden per
disclosure
Total annual
disclosures
312
1
312
8,654
5,085
44,055,590
87
1
87
20
1
20
Total hours 2
5
Total operating
and
maintenance
costs
(in dollars)
1,560
24,000,000
3,652,464
........................
0.5
44
........................
20
1
20
........................
1
20
200
4,000
300
20
1
20
320
6,400
600
5
1
5
100
500
19,375
5
1
5
2
10
........................
0.4
1
0.4
200
80
68
0.15
1
0.15
100
15
25.50
0.3
1
0.3
200
60
51
0.15
1
0.15
100
15
25.50
......................
..........................
........................
3,691,842
24,259,921
0.083
........................
There are no capital costs associated with this collection of information.
Total hours have been rounded.
Refers to the facility component of the burden for this requirement.
Refers to the AB component of the burden for this requirement.
Refers to the situation where a patient specifically does not want to receive the lay summary of her exam.
Dated: August 15, 2016.
Peter Lurie,
Associate Commissioner for Public Health
Strategy and Analysis.
[FR Doc. 2016–19808 Filed 8–18–16; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Service
Administration
Advisory Committee on
Interdisciplinary, Community-Based
Linkages; Notice of Meeting
mstockstill on DSK3G9T082PROD with NOTICES
Number of
disclosures per
respondent
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Public Law 92–463), notice is hereby
given of the following meeting:
Name: Advisory Committee on
Interdisciplinary, Community-Based
Linkages (ACICBL)
Dates and Times: September 19, 2016
Place: Webinar/Conference Call
Status: The meeting will be open to
the public.
Purpose: The ACICBL provides advice
and recommendations to the Secretary
of the Department of Health and Human
VerDate Sep<11>2014
18:08 Aug 18, 2016
Jkt 238001
Services (Secretary) concerning policy,
program development, and other
matters of significance related to
interdisciplinary, community-based
training grant programs authorized
under sections 750—759, Title VII, Part
D of the Public Health Service Act, as
amended by the Affordable Care Act.
The Advisory Committee focuses on the
targeted program areas and/or
disciplines for Area Health Education
Centers, geriatrics, allied health,
chiropractic, podiatric medicine, social
work, graduate psychology, and rural
health.
The purpose of the ACICBL meeting
is to continue discussions on the
ACICBL 16th report which is focused on
enhancing community-based clinical
training.
Agenda: The ACICBL agenda will be
available 2 days prior to the meeting on
the HRSA Web site at https://
www.hrsa.gov/advisorycommittees/
bhpradvisory/acicbl/.
SUPPLEMENTARY INFORMATION: Requests
to make oral comments or provide
written comments to the ACICBL should
be sent to Dr. Joan Weiss, Designated
Federal Official, using the address and
phone number below. Individuals who
PO 00000
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Fmt 4703
Sfmt 9990
plan to participate on the conference
call and webinar should notify Dr.
Weiss at least 3 days prior to the
meeting, using the address and phone
number below. Members of the public
will have the opportunity to provide
comments. Interested parties should
refer to the meeting subject as the HRSA
Advisory Committee on
Interdisciplinary, Community-Based
Linkages.
• The conference call-in number is 1–
800–619–2521. The passcode is:
9271697.
• The webinar link is https://
hrsa.connectsolutions.com/acicbl.
Contact: Anyone requesting
information regarding the ACICBL
should contact Dr. Joan Weiss, in one of
three ways: (1) Send a request to the
following address: Dr. Joan Weiss,
Designated Federal Official, Bureau of
Health Workforce, Health Resources and
Services Administration, Room 15N39,
5600 Fishers Lane, Rockville, Maryland
20857; (2) call (301) 443–0430; or (3)
send an email to jweiss@hrsa.gov.
Jason E. Bennett,
Director, Division of the Executive Secretariat.
[FR Doc. 2016–19814 Filed 8–18–16; 8:45 am]
BILLING CODE 4165–15–P
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19AUN1
]]>Agencies
[Federal Register Volume 81, Number 161 (Friday, August 19, 2016)]
[Notices]
[Pages 55463-55466]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-19808]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
SUMMARY: 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
September 19, 2016.
ADDRESSES: 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 0910-0309.
Also include the FDA docket number found in brackets in the heading of
this document.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, Three White Flint North,10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, PRAStaff@fda.hhs.gov.
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; 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). 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 1 hour, it has been
rounded to 1 hour. All other ``Total Hours'' have been rounded to the
nearest whole number.)
[[Page 55464]]
We do not expect any respondents for Sec. 900.3(c) because all
four ABs are approved until April 2020.
In the Federal Register of June 8, 2016 (81 FR 36924), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Average Total operating and
Activity/21 CFR Section/Form FDA No. Number of responses Total annual burden per Total hours capital maintenance
respondents per responses response \1\ costs (in costs (in
respondent dollars) dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\-- 0.33 1 0.33 320 106 10,000 ..............
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)..................... 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 0.1 1 0.1 1 1 ........... ..............
authority--900.3(e).................................
Summary report describing all facility assessments-- 330 1 330 7 2,310 ........... 77,600
900.4(f)............................................
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 ........... ..............
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-- 0.1 1 0.1 30 3 ........... ..............
900.21(c)(2)........................................
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--Form FDA 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
Number of Average Total capital operating and
Activity/21 CFR Section Number of records per Total annual burden per Total hours costs (in maintenance
recordkeepers recordkeeper records recordkeeping \1\ dollars) costs (in
dollars)
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AB transfer of facility records-- 0.1 1 0.1 0 1 .............. ..............
900.3(f)(1)...............................
[[Page 55465]]
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 8,654 4 34,616 1 34,616 .............. ..............
personnel 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-- 8,654 52 450,008 0.083 37,351 .............. ..............
900.12(e)(13).............................
Audit program--900.12(f)................... 8,654 1 8,654 16 138,464 .............. ..............
Consumer complaints system; facility-- 8,654 2 17,308 1 17,308 .............. ..............
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 5 1 5 1 5 .............. ..............
review--900.22(f).........................
Processes for patient notifications-- 3 1 3 1 3 .............. 30
900.22(g).................................
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.
Table 3--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Average operating and
Activity/21 CFR Section Number of disclosures per Total annual burden per Total hours maintenance
respondents respondent disclosures disclosure \2\ costs (in
dollars)
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Notification of facilities that AB relinquishes its 0.1 1 0.1 200 20 50
accreditation--900.3(f)(2)................................
Clinical images; facility \3\--900.4(c), 900.11(b)(1) and 2,885 1 2,885 1.44 4,154 ..............
(2).......................................................
Clinical images; AB \4\--900.4(c).......................... 5 1 5 416 2,080 230,773
Phantom images; facility \3\--900.4(d), 900.11(b)(1) and 2,885 1 2,885 0.72 2,077 ..............
(2).......................................................
Phantom images; AB \4\--900.4(d)........................... 5 1 5 208 1,040 ..............
Annual equipment evaluation and survey; facility \3\-- 8,654 1 8,654 1 8,654 8,654
900.4(e), 900.11(b)(1) and (2)............................
Annual equipment evaluation and survey; AB \4\--900.4(e)... 5 1 5 1,730 8,650 ..............
Provisional mammography facility certificate extension 0 1 0 0.5 1 ..............
application--900.11(b)(3).................................
[[Page 55466]]
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 44,055,590 0.083 3,652,464 ..............
Lay summary of examination; patient refusal \5\-- 87 1 87 0.5 44 ..............
900.12(c)(2)..............................................
Report of unresolved serious complaints--900.12(h)(4)...... 20 1 20 1 20 ..............
Information regarding compromised quality; facility \3\-- 20 1 20 200 4,000 300
900.12(j)(1)..............................................
Information regarding compromised quality; AB \4\-- 20 1 20 320 6,400 600
900.12(j)(1)..............................................
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-- 0.15 1 0.15 100 15 25.50
900.24(a)(2)..............................................
Notification of probationary status--900.24(b)(1).......... 0.3 1 0.3 200 60 51
Notification of loss of approval; minor deficiencies-- 0.15 1 0.15 100 15 25.50
900.24(b)(3)..............................................
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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.
\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.
Dated: August 15, 2016.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2016-19808 Filed 8-18-16; 8:45 am]
BILLING CODE 4164-01-P
