Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Mammography Quality Standards Act Requirements, 39731-39734 [2013-15790]
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Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices
tkelley on DSK3SPTVN1PROD with NOTICES
Dated: June 25, 2013.
Michelle Snyder,
Deputy Chief Operating Officer, Centers for
Medicare & Medicaid Services.
CMS Computer Match No. 2013–11;
HHS Computer Match No. 1302
Name: ‘‘Computer Matching
Agreement between the Centers for
Medicare & Medicaid Services and
State-based Administering Entities for
the Disclosure of Health Insurance
Affordability Programs Information
under the Patient Protection and
Affordable Care Act.’’
Security Classification: Unclassified.
Participating Agencies: Department of
Health and Human Services (HHS),
Centers for Medicare & Medicaid
Services (CMS), and State-based
Administering Entities (AEs).
Authority For Conducting Matching
Program: This Computer Matching
Program (CMP) is executed to comply
with the provisions of the Privacy Act
of 1974 (5 U.S.C. 552a), as amended, the
Office of Management and Budget
(OMB) Circular A–130 entitled,
Management of Federal Information
Resources, at 61 FR 6428–6435
(February 20, 1996), and OMB
guidelines pertaining to computer
matching at 54 FR 25818 (June 19, 1989)
and 56 FR 18599 (April 23, 1991); and
the computer matching portions of
Appendix I to OMB Circular No. A–130
as amended at 61 FR 6428 (February 20,
1996).
Purpose(s) of the Matching Program:
This Computer Matching Agreement
(CMA) establishes the terms, conditions,
safeguards, and procedures under which
CMS will share certain information with
the AEs in accordance with the Patient
Protection and Affordable Care Act of
2010 (Pub. L. 111–148), as amended by
the Health Care and Education
Reconciliation Act of 2010 (Pub. L. 111–
152), which are referred to collectively
as the Affordable Care Act (ACA), as
well as the implementing regulations.
Under this CMA the State-based AEs
will use the data, accessed through the
CMS Data Services Hub, to make
Eligibility Determinations for Insurance
Affordability Programs and certificates
of exemption. State-based AEs are state
entities administering Insurance
Affordability Programs and may include
a State agency, a State Children’s Health
Insurance Program, a State basic health
program or a Marketplace (Exchange).
Description of Records to be Used In
the Matching Program:
System of Records Maintained by CMS
The matching program will be
conducted with data maintained by
CMS in the ‘‘Health Insurance
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Exchanges (HIX) Program,’’ System No.
09–70–0560 established at 78 FR 8538
on February 6, 2013, and amended at 78
FR 32256 on May 29, 2013.
Inclusive Dates of the Match: The
CMP shall become effective no sooner
than 40 days after the report of the
Matching Program is sent to OMB and
Congress, or 30 days after publication in
the Federal Register, whichever is later.
The matching program will continue for
18 months from the effective date and
may be extended for an additional 12
months thereafter, if certain conditions
are met.
[FR Doc. 2013–15819 Filed 7–1–13; 8:45 am]
BILLING CODE 4120–03–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 August 1,
2013.
SUMMARY:
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.
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Daniel Gittleson, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5156, daniel.gittleson@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: In
compliance with 44 U.S.C. 3507, FDA
has submitted the following proposed
PO 00000
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39731
collection of information to OMB for
review and clearance.
Mammography Quality Standards Act
Requirements—(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 (c)(3)
and 21 CFR 900.3(f)(1). Section
900.24(c) was also not included in the
burden tables because if a certifying
State had its approval withdrawn, FDA
would take over certifying authority for
the affected facilities. Because FDA
already has all the certifying State’s
electronic records, there wouldn’t be an
additional reporting burden.
We have rounded numbers in the
‘‘Total Hours’’ column in all three
burden tables. (Where the number was
a portion of 1 hour, it has been rounded
to 1 hour. All other ‘‘Total Hours’’ have
been rounded to the nearest whole
number.)
We do not expect any respondents for
§ 900.3(c) because all four ABs are
approved until April 2020.
E:\FR\FM\02JYN1.SGM
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39732
Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices
In the Federal Register of February
28, 2013 (78 FR 13681), 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
Average
burden per
response
Total annual
responses
Total
capital
costs
Total
hours 1
Total operating
& maintenance
costs
0.33
1
0.33
1
1
................
........................
0.33
1
0.33
320
106
$10,000
........................
5
0
1
1
5
0
30
15
150
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
................
........................
5
2
200
1
1000
2
0.083
30
83
60
30,000
................
........................
20
1
1
1
30
30
................
........................
0.2
1
0.2
16
3
................
........................
700
1
700
0.25
175
................
........................
........................
........................
........................
........................
11,777
40,000
82,155
1 Total
hours have been rounded.
time burden.
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.
2 One
3 Refers
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN
Number of
recordkeepers
tkelley on DSK3SPTVN1PROD with NOTICES
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) ................
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Number of
records per
recordkeeper
Average
burden per
recordkeeping
Total annual
records
Total
capital
costs
Total
hours 1
Total operating
& maintenance
costs
0.1
1
0.1
0
1
................
........................
5
1
5
1
5
................
........................
87
1
87
8
696
................
........................
8,654
4
34,616
1
34,616
................
........................
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39733
Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued
Number of
recordkeepers
Activity/21 CFR section
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
Total
hours 1
Total operating
& maintenance
costs
8,654
1
8,654
1
8,654
$28,000
........................
8,654
8,654
52
1
450,008
8,654
0.083
16
37,351
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
hours have been rounded.
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURES 1
tkelley on DSK3SPTVN1PROD with NOTICES
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) ..............................................
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) .................................
VerDate Mar<15>2010
17:51 Jul 01, 2013
Jkt 229001
Number of
disclosures
per
respondent
Number of
respondents
Activity/21 CFR section
PO 00000
Average
burden per
disclosure
Total annual
disclosures
Total operating
& maintenance
costs
Total
hours 2
0.1
1
0.1
200
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
0.5
1
........................
312
8,654
1
5,085
312
44,055,590
5
0.083
1,560
3,652,464
24,000,000
........................
87
1
87
0.5
44
........................
20
1
20
1
20
........................
20
1
20
200
4,000
300
20
1
20
320
6,400
600
5
5
1
1
5
5
100
2
500
10
19,375
........................
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
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39734
Federal Register / Vol. 78, No. 127 / Tuesday, July 2, 2013 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURES 1—Continued
Number of
respondents
Activity/21 CFR section
Total ..........................................................
Number of
disclosures
per
respondent
Total annual
disclosures
Average
burden per
disclosure
Total
hours 2
........................
........................
........................
........................
3,691,842
Total operating
& maintenance
costs
24,259,921
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: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
Dated: June 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–15790 Filed 7–1–13; 8:45 am]
[FR Doc. 2013–15795 Filed 7–1–13; 8:45 am]
BILLING CODE 4160–01–P
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
Food and Drug Administration
[Docket No. FDA–2013–N–0033]
[Docket No. FDA–2012–N–1108]
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Interstate Shellfish Dealer’s Certificate
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
AGENCY:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Interstate Shellfish Dealer’s
Certificate’’ has been approved by the
Office of Management and Budget
(OMB) under the Paperwork Reduction
Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On March
25, 2013, the Agency submitted a
proposed collection of information
entitled, ‘‘Interstate Shellfish Dealer’s
Certificate’’ to OMB for review and
clearance under 44 U.S.C. 3507. An
Agency may not conduct or sponsor,
and a person is not required to respond
to, a collection of information unless it
displays a currently valid OMB control
number. OMB has now approved the
information collection and has assigned
OMB control number 0910–0021. The
approval expires on May 31, 2016. A
copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
VerDate Mar<15>2010
17:51 Jul 01, 2013
Food and Drug Administration,
HHS.
SUMMARY:
tkelley on DSK3SPTVN1PROD with NOTICES
Agency Information Collection
Activities; Announcement of Office of
Management and Budget Approval;
Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water
Jkt 229001
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing
that a collection of information entitled
‘‘Recordkeeping Requirements for
Microbiological Testing and Corrective
Measures for Bottled Water’’ has been
approved by the Office of Management
and Budget (OMB) under the Paperwork
Reduction Act of 1995.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Information
Management, Food and Drug
Administration, 1350 Piccard Dr., PI50–
400B, Rockville, MD 20850, 301–796–
5733, domini.bean@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: On March
26, 2013, the Agency submitted a
proposed collection of information
entitled ‘‘Recordkeeping Requirements
for Microbiological Testing and
Corrective Measures for Bottled Water’’
to OMB for review and clearance under
44 U.S.C. 3507. An Agency may not
conduct or sponsor, and a person is not
required to respond to, a collection of
information unless it displays a
currently valid OMB control number.
OMB has now approved the information
collection and has assigned OMB
control number 0910–0658. The
approval expires on May 31, 2016. A
SUMMARY:
PO 00000
Frm 00031
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copy of the supporting statement for this
information collection is available on
the Internet at https://www.reginfo.gov/
public/do/PRAMain.
Dated: June 26, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–15793 Filed 7–1–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0716]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Designated New
Animal Drugs for Minor Use and Minor
Species
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing an
opportunity for public comment on the
proposed collection of certain
information by the Agency. Under the
Paperwork Reduction Act of 1995 (the
PRA), Federal Agencies are required to
publish notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension of an existing collection of
information, and to allow 60 days for
public comment in response to the
notice. This notice solicits comments on
the paperwork associated with
designation under the Minor Use and
Minor Species (MUMS) Act.
DATES: Submit either electronic or
written comments on the collection of
information by September 3, 2013.
ADDRESSES: Submit electronic
comments on the collection of
information to https://
www.regulations.gov. Submit written
comments on the collection of
information to the Division of Dockets
Management (HFA–305), Food and Drug
SUMMARY:
E:\FR\FM\02JYN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 127 (Tuesday, July 2, 2013)]
[Notices]
[Pages 39731-39734]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-15790]
-----------------------------------------------------------------------
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 August
1, 2013.
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: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850, 301-796-5156,
daniel.gittleson@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--(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 (c)(3) and 21 CFR 900.3(f)(1). Section 900.24(c) was also not
included in the burden tables because if a certifying State had its
approval withdrawn, FDA would take over certifying authority for the
affected facilities. Because FDA already has all the certifying State's
electronic records, there wouldn't be an additional reporting burden.
We have rounded numbers in the ``Total Hours'' column in all three
burden tables. (Where the number was a portion of 1 hour, it has been
rounded to 1 hour. All other ``Total Hours'' have been rounded to the
nearest whole number.)
We do not expect any respondents for Sec. 900.3(c) because all
four ABs are approved until April 2020.
[[Page 39732]]
In the Federal Register of February 28, 2013 (78 FR 13681), 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 Number of Total annual Average Total Total operating &
Activity/21 CFR section/form FDA No. respondents responses per responses burden per hours \1\ capital maintenance
respondent response costs costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 $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-- 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 ......... $77,600
assessments--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-- 5 200 1000 0.083 83 30,000 ..............
900.22(h)........................................
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 ......... ..............
-----------------------------------------------------------------------------------------------------
Total......................................... .............. .............. .............. .............. 11,777 40,000 82,155
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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 Number of Total annual Average burden Total Total operating &
Activity/21 CFR section recordkeepers records per records per hours \1\ capital maintenance
recordkeeper recordkeeping costs costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
AB transfer of facility records--900.3(f)(1)...... 0.1 1 0.1 0 1 ......... ..............
Consumer complaints system; AB--900.4(g).......... 5 1 5 1 5 ......... ..............
Documentation of interpreting physician initial 87 1 87 8 696 ......... ..............
requirements--900.12(a)(1)(i)(B)(2)..............
Documentation of interpreting physician personnel 8,654 4 34,616 1 34,616 ......... ..............
requirements--900.12(a)(4).......................
[[Page 39733]]
Permanent medical record--900.12(c)(4)............ 8,654 1 8,654 1 8,654 $28,000 ..............
Procedures for cleaning equipment--900.12(e)(13).. 8,654 52 450,008 0.083 37,351 ......... ..............
Audit program--900.12(f).......................... 8,654 1 8,654 16 138,464 ......... ..............
Consumer complaints system; facility--900.12(h)(2) 8,654 2 17,308 1 17,308 ......... ..............
Certification agency conflict of interest-- 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 ......... $30
Evaluation of certification agency--900.23........ 5 1 5 20 100 ......... ..............
Appeals--900.25(b)................................ 5 1 5 1 5 ......... ..............
-----------------------------------------------------------------------------------------------------
Total......................................... .............. .............. .............. .............. 237,223 28,000 30
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Total hours have been rounded.
Table 3--Estimated Annual Third-Party Disclosures \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Number of Total annual Average burden Total operating &
Activity/21 CFR section respondents disclosures disclosures per disclosure hours \2\ maintenance
per respondent costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 ..............
900.11(b)(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 ..............
900.11(b)(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 900.11(b)(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)...................................
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\--900.12(c)(2) 87 1 87 0.5 44 ..............
Report of unresolved serious complaints--900.12(h)(4)........ 20 1 20 1 20 ..............
Information regarding compromised quality; facility \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)................................................
------------------------------------------------------------------------------------------
[[Page 39734]]
Total.................................................... .............. .............. .............. .............. 3,691,842 24,259,921
--------------------------------------------------------------------------------------------------------------------------------------------------------
\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: June 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-15790 Filed 7-1-13; 8:45 am]
BILLING CODE 4160-01-P
