Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements, 13681-13684 [2013-04677]
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13681
Federal Register / Vol. 78, No. 40 / Thursday, February 28, 2013 / Notices
Annual
number of
respondents
Instrument respondent
Number of
responses per
respondent
Average
burden per
response
(hours)
Total annual
burden hours
IMPACT
Healthy Marriage Grantee Impact Evaluation
(4) Introductory script Program staff ................................................................
Program applicants ..........................................................................................
(5) Baseline survey Study participants ............................................................
30
4,210
4,000
70.2
1
1
0.167
0.167
0.5
351
702
2,000
3,400
0.033
3,400
Healthy Marriage Grantee Implementation Evaluation—MIS
(7) HM Study MIS Program staff .....................................................................
30
Responsible Fatherhood and Healthy Marriage Grantee Implementation Evaluation—Additional Implementation Data Collection
Instruments
(8) Semi-structured interview topic guide Program staff .................................
(9) On-line survey Program staff .....................................................................
(10) Telephone interviews (with staff at referral organizations):
Program staff at referral organizations .....................................................
(11) On-line Working Alliance Inventory:
(1) Program staff ......................................................................................
(2) Program Participants ...........................................................................
(12) Focus group guide Program participants .................................................
(13) Telephone interviews Program participants (program dropouts) .............
250
250
2
2
1.03
0.5
517
250
50
1
0.5
25
50
1,000
600
150
20
1
1
1
0.167
0.167
1.5
0.25
167
167
900
38
3
4
2
0.167
192
21
Responsible Fatherhood Grantee Qualitative Evaluation
(14) Guide for in-person, in-depth interviews Study participants ....................
(15) Check-in call guide Study participants .....................................................
32
32
IMPLEMENTATION/QUALITATIVE ONLY
Responsible Fatherhood Grantee Implementation Evaluation—Grantees With a Focus on Hispanic Populations
42
20
20
1
1
1
1.5
1.5
0.333
63
30
7
Total ...................................................................................................
mstockstill on DSK4VPTVN1PROD with NOTICES
(16) Semi-structured interview topic guide Program staff ...............................
(17) Focus group guide Program participants .................................................
(18) Questionnaires Program participants in focus groups .............................
........................
........................
........................
8,830
Additional Information: Copies of the
proposed collection may be obtained by
writing to the Administration for
Children and Families, Office of
Planning, Research, and Evaluation, 370
L’Enfant Promenade SW., Washington,
DC 20447, Attn: OPRE Reports
Clearance Officer. All requests should
be identified by the title of the
information collection. Email address:
OPREinfocollection@acf.hhs.gov.
In compliance with the requirements
of Section 3506(c)(2)(A) of the
Paperwork Reduction Act of 1995, the
Administration for Children and
Families is soliciting public comment
on the specific aspects of the
information collection described above.
Copies of the proposed collection of
information can be obtained and
comments may be forwarded by writing
to the Administration for Children and
Families, Office of Planning, Research
and Evaluation, 370 L’Enfant
Promenade SW., Washington, DC 20447,
Attn: OPRE Reports Clearance Officer.
Email address: OPREinfocollection@acf.
hhs.gov. All requests should be
VerDate Mar<15>2010
19:12 Feb 27, 2013
Jkt 229001
identified by the title of the information
collection.
OMB Comment: OMB is required to
make a decision concerning the
collection of information between 30
and 60 days after publication of this
document in the Federal Register.
Therefore, a comment is best assured of
having its full effect if OMB receives it
within 30 days of publication. Written
comments and recommendations for the
proposed information collection should
be sent directly to the following: Office
of Management and Budget, Paperwork
Reduction Project, Fax: 202–395–6974,
Attn: Desk Officer for the
Administration for Children and
Families.
Steven M. Hanmer,
Reports Clearance Officer.
[FR Doc. 2013–04307 Filed 2–27–13; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2013–N–0134]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Mammography
Quality Standards Act Requirements
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
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
SUMMARY:
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Federal Register / Vol. 78, No. 40 / Thursday, February 28, 2013 / Notices
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 April 29, 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
Administration, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852. All
comments should be identified with the
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: 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 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 one 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.
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
mstockstill on DSK4VPTVN1PROD with NOTICES
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) ...........
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Number of
respondents
Number of
responses
per respondent
Total annual
responses
Average
burden per
response
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
0.1
1
1
1
5
0
0.1
30
15
30
150
1
3
....................
....................
....................
....................
....................
....................
0.1
1
0.1
30
3
....................
....................
0.1
1
0.1
1
1
....................
....................
7
1
10
16
2,310
8,654
50
16
....................
....................
....................
....................
$77,600
4,327
....................
....................
330
8,654
5
1
PO 00000
1
1
1
1
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330
8,654
5
1
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TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN—Continued
Activity/21 CFR Section/FDA Form No.
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—FDA Form
3422 ....................................................
Total ................................................
Number of
respondents
Number of
responses
per respondent
Total annual
responses
0.1
1
0.1
1
1
2
10
Average
burden per
response
Total capital
costs
Total
hours 1
Total operating &
maintenance costs
60
6
....................
....................
1
2
2
....................
....................
1
2
2
4
....................
....................
1
10
1
10
....................
....................
0.33
1
0.33
320
106
....................
$208
0.1
1
0.1
30
3
....................
....................
0.083
30
83
60
$30,000
....................
....................
$20
5
2
200
1
1000
2
1
1
1
30
30
....................
....................
0.2
1
0.2
16
3
....................
....................
175
....................
....................
11,777
40,000
82,155
Total capital
costs
Total operating and
maintenance costs
700
1
......................
700
....................
0.25
....................
....................
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
No. of recordkeepers
mstockstill on DSK4VPTVN1PROD 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)
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
No. of
records per
recordkeeper
Average
burden per
recordkeeping
Total
annual
records
Total
hours 1
0.1
1
0.1
0
1
....................
....................
5
1
5
1
5
....................
....................
87
1
87
8
696
....................
....................
8,654
8,654
4
1
34,616
8,654
1
1
34,616
8,654
....................
$28,000
....................
....................
8,654
8,654
52
1
450,008
8,654
37,351
138,464
....................
....................
....................
....................
8,654
2
17,308
1
17,308
....................
....................
5
1
5
1
5
....................
....................
5
5
1
1
5
5
1
1
5
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
16
..................
....................
hours have been rounded.
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Federal Register / Vol. 78, No. 40 / Thursday, February 28, 2013 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURES 1
Number of
respondents
Notification of facilities that AB relinquishes its
accreditation—900.3(f)(2) .................................
Clinical images; facility 2—900.4(c), 900.11(b)(1),
and 900.11(b)(2) ...............................................
Clinical images; AB 3—900.4(c) ...........................
Phantom
images;
facility 2—900.4(d),
900.11(b)(1), and 900.11(b)(2) .........................
Phantom images; AB 3—900.4(d) ........................
Annual equipment evaluation and survey; facility 2—900.4(e), 900.11(b)(1), and 900.11(b)(2)
Annual equipment evaluation and survey; AB 3—
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 4—
900.12(c)(2) ......................................................
Report of unresolved serious complaints—
900.12(h)(4) ......................................................
Information regarding compromised quality; facility 2—900.12(j)(1) ..............................................
Information regarding compromised quality;
AB 3—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 ..............................................................
Number of
disclosures
per respondent
Total annual
disclosures
0.1
Activity/21 CFR Section
1
0.1
Average
burden per
disclosure
200
Total operating
and maintenance costs
Total
hours 2
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
........................
312
8,654
1
5,085
312
44,005,590
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
5
5
1
1
1
20
5
5
320
100
2
6,400
500
10
600
19,375
........................
0.5
5
0.083
0.4
1
0.4
200
80
68
0.15
0.3
1
1
0.15
0.3
100
200
15
60
25.50
51
0.15
1
0.15
100
15
25.50
......................
....................
..........................
3,691,842
24,259,921
....................
1 There
2 Total
are no capital costs associated with this collection of information.
hours have been rounded.
Dated: February 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013–04677 Filed 2–27–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–E–0156]
mstockstill on DSK4VPTVN1PROD with NOTICES
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ZYTIGA
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ZYTIGA and is publishing this notice of
that determination as required by law.
SUMMARY:
VerDate Mar<15>2010
19:12 Feb 27, 2013
Jkt 229001
FDA has made the determination
because of the submission of an
application to the Director of Patents
and Trademarks, Department of
Commerce, for the extension of a patent
which claims that human drug product.
ADDRESSES: Submit electronic
comments to https://
www.regulations.gov. Submit written
petitions along with three copies and
written comments to the Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT:
Beverly Friedman, Office of Regulatory
Policy, Food and Drug Administration,
10903 New Hampshire Ave., Bldg. 51,
rm. 6284, Silver Spring, MD 20993–
0002, 301–796–3602.
SUPPLEMENTARY INFORMATION: The Drug
Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98–417)
and the Generic Animal Drug and Patent
Term Restoration Act (Pub. L. 100–670)
PO 00000
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generally provide that a patent may be
extended for a period of up to 5 years
so long as the patented item (human
drug product, animal drug product,
medical device, food additive, or color
additive) was subject to regulatory
review by FDA before the item was
marketed. Under these acts, a product’s
regulatory review period forms the basis
for determining the amount of extension
an applicant may receive.
A regulatory review period consists of
two periods of time: A testing phase and
an approval phase. For human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
Although only a portion of a regulatory
review period may count toward the
E:\FR\FM\28FEN1.SGM
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]]>Agencies
[Federal Register Volume 78, Number 40 (Thursday, February 28, 2013)]
[Notices]
[Pages 13681-13684]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-04677]
-----------------------------------------------------------------------
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) 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
[[Page 13682]]
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 April 29, 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 Administration, 5630 Fishers Lane, Rm. 1061,
Rockville, MD 20852. All comments should be identified with the 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: 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 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 one 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.
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total
Number of responses Total Average Total hours Total operating &
Activity/21 CFR Section/FDA Form No. respondents per annual burden per \1\ capital maintenance
respondent responses response costs costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
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\--900.3(b)(3).... 0.33 1 0.33 320 106 $10,000 ...........
Application for approval as an AB; limited \3\--900.3(b)(3). 5 1 5 30 150 ........... ...........
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 authority-- 0.1 1 0.1 1 1 ........... ...........
900.3(e)...................................................
Summary report describing all facility assessments--900.4(f) 330 1 330 7 2,310 ........... $77,600
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 ........... ...........
[[Page 13683]]
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--900.21(c)(2). 0.1 1 0.1 30 3 ........... ...........
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--FDA Form 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
No. of Total Average Total operating
Activity/21 CFR Section No. of records per annual burden per Total hours capital and
recordkeepers recordkeeper records recordkeeping \1\ costs maintenance
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)..............................
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--900.22(a)..... 5 1 5 1 5 ........... ...........
Processes for suspension and revocation of certificates-- 5 1 5 1 5 ........... ...........
900.22(d)...............................................
Processes for appeals--900.22(e)......................... 5 1 5 1 5 ........... ...........
Processes for additional mammography review--900.22(f)... 5 1 5 1 5 ........... ...........
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.
[[Page 13684]]
Table 3--Estimated Annual Third-Party Disclosures \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Total
Number of disclosures Total annual Average Total hours operating and
Activity/21 CFR Section respondents per disclosures burden per \2\ maintenance
respondent disclosure costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notification of facilities that AB relinquishes its accreditation-- 0.1 1 0.1 200 20 $50
900.3(f)(2).......................................................
Clinical images; facility \2\--900.4(c), 900.11(b)(1), and 2,885 1 2,885 1.44 4,154 ..............
900.11(b)(2)......................................................
Clinical images; AB \3\--900.4(c).................................. 5 1 5 416 2,080 230,773
Phantom images; facility \2\--900.4(d), 900.11(b)(1), and 2,885 1 2,885 0.72 2,077 ..............
900.11(b)(2)......................................................
Phantom images; AB \3\--900.4(d)................................... 5 1 5 208 1,040 ..............
Annual equipment evaluation and survey; facility \2\--900.4(e), 8,654 1 8,654 1 8,654 8,654
900.11(b)(1), and 900.11(b)(2)....................................
Annual equipment evaluation and survey; AB \3\--900.4(e)........... 5 1 5 1,730 8,650 ..............
Provisional mammography facility certificate extension application-- 0 1 0 0.5 1 ..............
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 44,005,590 0.083 3,652,464 ..............
Lay summary of examination; patient refusal \4\--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 \2\-- 20 1 20 200 4,000 300
900.12(j)(1)......................................................
Information regarding compromised quality; AB \3\--900.12(j)(1).... 20 1 20 320 6,400 600
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--900.24(a)(2). 0.15 1 0.15 100 15 25.50
Notification of probationary status--900.24(b)(1).................. 0.3 1 0.3 200 60 51
Notification of loss of approval; minor deficiencies--900.24(b)(3). 0.15 1 0.15 100 15 25.50
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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.
Dated: February 22, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-04677 Filed 2-27-13; 8:45 am]
BILLING CODE 4160-01-P
