Agency Information Collection Activities; Proposed Collection; Comment Request; Mammography Quality Standards Act Requirements, 36924-36928 [2016-13522]
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36924
Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices
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Dated: June 2, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical
Programs.
[FR Doc. 2016–13457 Filed 6–7–16; 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; 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
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 August 8, 2016.
ADDRESSES: You may submit comments
as follows:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
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Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices
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comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2013–N–0134 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Mammography Quality Standards Act
Requirements.’’ Received comments
will be placed in the docket and, except
for those submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Division of Dockets Management
between 9 a.m. and 4 p.m., Monday
through Friday.
• Confidential Submissions—To
submit a comment with confidential
information that you do not wish to be
made publicly available, submit your
comments only as a written/paper
submission. You should submit two
copies total. One copy will include the
information you claim to be confidential
with a heading or cover note that states
‘‘THIS DOCUMENT CONTAINS
CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
the claimed confidential information, in
its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
Management. If you do not wish your
name and contact information to be
made publicly available, you can
provide this information on the cover
sheet and not in the body of your
comments and you must identify this
information as ‘‘confidential.’’ Any
information marked as ‘‘confidential’’
will not be disclosed except in
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accordance with 21 CFR 10.20 and other
applicable disclosure law. For more
information about FDA’s posting of
comments to public dockets, see 80 FR
56469, September 18, 2015, or access
the information at: https://www.fda.gov/
regulatoryinformation/dockets/
default.htm.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov and insert the
docket number, found in brackets in the
heading of this document, into the
‘‘Search’’ box and follow the prompts
and/or go to the Division of Dockets
Management, 5630 Fishers Lane, Rm.
1061, Rockville, MD 20852.
FDA
PRA Staff, Office of Operations, Food
and Drug Administration, 8455
Colesville Rd., COLE–14526, Silver
Spring, MD 20993–0002, PRAStaff@
fda.hhs.gov.
FOR FURTHER INFORMATION CONTACT:
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,
SUPPLEMENTARY INFORMATION:
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36925
when appropriate, and other forms of
information technology.
Mammography Quality Standards Act
Requirements—21 CFR Part 900—OMB
Control Number 0910–0309—Extension
The Mammography Quality Standards
Act (Pub. L. 102–539) requires the
establishment of a Federal certification
and inspection program for
mammography facilities; regulations
and standards for accreditation and
certification bodies for mammography
facilities; and standards for
mammography equipment, personnel,
and practices, including quality
assurance. The intent of these
regulations is to assure safe, reliable,
and accurate mammography on a
nationwide level. Under the regulations,
as a first step in becoming certified,
mammography facilities must become
accredited by an FDA-approved
accreditation body (AB). This requires
undergoing a review of their clinical
images and providing the AB with
information showing that they meet the
equipment, personnel, quality
assurance, and quality control
standards, and have a medical reporting
and recordkeeping program, a medical
outcomes audit program, and a
consumer complaint mechanism. On the
basis of this accreditation, facilities are
then certified by FDA or an FDAapproved State certification agency and
must prominently display their
certificate. These actions are taken to
ensure safe, accurate, and reliable
mammography on a nationwide basis.
The following sections of Title 21 of
the Code of Federal Regulations (CFR)
are not included in the burden tables
because they are considered usual and
customary practice and were part of the
standard of care prior to the
implementation of the regulations.
Therefore, they resulted in no additional
burden: 21 CFR 900.12(c)(1) and (3) and
900.3(f)(1). 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.
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Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices
FDA estimates the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN
Activity/21 CFR section/FDA form
No.
Number of
respondents
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—FDA
Form 3422 ..................................
Total ........................................
Number of
responses per
respondent
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
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 (FFDM) 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
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Activity/21 CFR
section
Number of
recordkeepers
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
Total
annual
records
Average
burden per
recordkeeping
Total
capital
costs
(in dollars)
Total
hours 1
Total
operating
and
maintenance
costs
(in dollars)
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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Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices
TABLE 2—ESTIMATED ANNUAL RECORDKEEPING BURDEN—Continued
Activity/21 CFR
section
Number of
recordkeepers
Permanent medical record—
900.12(c)(4) ............................
Procedures for cleaning equipment—900.12(e)(13) ..............
Audit program—900.12(f) ..........
Consumer complaints system;
facility—900.12(h)(2) ..............
Certification agency conflict of
interest—900.22(a) .................
Processes for suspension and
revocation of certificates—
900.22(d) ................................
Processes for appeals—
900.22(e) ................................
Processes for additional mammography review—900.22(f) ..
Processes for patient notifications—900.22(g) .....................
Evaluation of certification agency—900.23 .............................
Appeals—900.25(b) ...................
Total ....................................
1 Total
Number of
records per
recordkeeper
Total
annual
records
Average
burden per
recordkeeping
Total
capital
costs
(in dollars)
Total
hours 1
Total
operating
and
maintenance
costs
(in dollars)
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 DISCLOSURE BURDEN 1
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Activity/21 CFR
section
Number
of respondents
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) ..........................................
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) ..............................................
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Jkt 238001
Number of
disclosures
per
respondent
Total
annual
disclosures
Average
burden per
disclosure
Total
operating
and
maintenance
costs
(in dollars)
Total
hours 2
0.1
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
1
312
5
1,560
24,000,000
8,654
5,085
44,055,590
0.083
3,652,464
........................
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
1
5
100
500
19,375
5
PO 00000
1
1
5
2
10
........................
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Federal Register / Vol. 81, No. 110 / Wednesday, June 8, 2016 / Notices
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1—Continued
Activity/21 CFR
section
Number of
disclosures
per
respondent
Number
of respondents
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 ..................................................
Total
annual
disclosures
Average
burden per
disclosure
Total
operating
and
maintenance
costs
(in dollars)
Total
hours 2
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
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 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
December 5, 2016. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
[FR Doc. 2016–13522 Filed 6–7–16; 8:45 am]
ADDRESSES:
BILLING CODE 4164–01–P
as follows:
You may submit comments
Electronic Submissions
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2014–E–2351, FDA–
2014–E–2352, and FDA–2014–E–2350]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; ALPROLIX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) has determined
the regulatory review period for
ALPROLIX and is publishing this notice
of that determination as required by
law. FDA has made the determination
because of the submission of
applications to the Director of the U.S.
Patent and Trademark Office (USPTO),
Department of Commerce, for the
extension of patents which claim that
human biological product.
DATES: Anyone with knowledge that any
of the dates as published (see the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 8, 2016.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
mstockstill on DSK3G9T082PROD with NOTICES
SUMMARY:
VerDate Sep<11>2014
17:30 Jun 07, 2016
Jkt 238001
Submit electronic comments in the
following way:
• Federal eRulemaking Portal: https://
www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
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comments, that information will be
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• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand delivery/Courier (for
written/paper submissions): Division of
Dockets Management (HFA–305), Food
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
and Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Division of Dockets
Management, FDA will post your
comment, as well as any attachments,
except for information submitted,
marked and identified, as confidential,
if submitted as detailed in
‘‘Instructions.’’
Instructions: All submissions received
must include the Docket Nos. FDA–
2014–E–2351, FDA–2014–E–2352, and
FDA–2014–E–2350 for ‘‘Determination
of Regulatory Review Period for
Purposes of Patent Extension;
ALPROLIX.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
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• Confidential Submissions—To
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submission. You should submit two
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CONFIDENTIAL INFORMATION.’’ The
Agency will review this copy, including
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its consideration of comments. The
second copy, which will have the
claimed confidential information
redacted/blacked out, will be available
for public viewing and posted on https://
www.regulations.gov. Submit both
copies to the Division of Dockets
E:\FR\FM\08JNN1.SGM
08JNN1
]]>Agencies
[Federal Register Volume 81, Number 110 (Wednesday, June 8, 2016)]
[Notices]
[Pages 36924-36928]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-13522]
-----------------------------------------------------------------------
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 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 August 8, 2016.
ADDRESSES: You may submit comments as follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your
[[Page 36925]]
comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2013-N-0134 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Mammography Quality Standards Act
Requirements.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Division of Dockets Management. If you do not
wish your name and contact information to be made publicly available,
you can provide this information on the cover sheet and not in the body
of your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: FDA PRA Staff, Office of Operations,
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver
Spring, MD 20993-0002, PRAStaff@fda.hhs.gov.
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3520), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Mammography Quality Standards Act Requirements--21 CFR Part 900--OMB
Control Number 0910-0309--Extension
The Mammography Quality Standards Act (Pub. L. 102-539) requires
the establishment of a Federal certification and inspection program for
mammography facilities; regulations and standards for accreditation and
certification bodies for mammography facilities; and standards for
mammography equipment, personnel, and practices, including quality
assurance. The intent of these regulations is to assure safe, reliable,
and accurate mammography on a nationwide level. Under the regulations,
as a first step in becoming certified, mammography facilities must
become accredited by an FDA-approved accreditation body (AB). This
requires undergoing a review of their clinical images and providing the
AB with information showing that they meet the equipment, personnel,
quality assurance, and quality control standards, and have a medical
reporting and recordkeeping program, a medical outcomes audit program,
and a consumer complaint mechanism. On the basis of this accreditation,
facilities are then certified by FDA or an 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.)
We do not expect any respondents for Sec. 900.3(c) because all
four ABs are approved until April 2020.
[[Page 36926]]
FDA estimates the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Total Average Total operating and
Activity/21 CFR section/FDA form No. Number of responses per annual burden per Total capital maintenance
respondents respondent responses response hours \1\ costs (in costs (in
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--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 (FFDM) units.
\4\ Refers to the facility component of the burden for this requirement.
\5\ Refers to the AB component of the burden for this requirement.
Table 2--Estimated Annual Recordkeeping Burden
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of Total Average burden Total operating and
Activity/21 CFR section Number of records per annual per Total capital maintenance
recordkeepers recordkeeper records recordkeeping hours \1\ costs (in costs (in
dollars) dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 36927]]
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 Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total
Number of operating and
Activity/21 CFR section Number of disclosures Total annual Average burden Total hours maintenance
respondents per respondent disclosures per disclosure \2\ costs (in
dollars)
--------------------------------------------------------------------------------------------------------------------------------------------------------
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) 2,885 1 2,885 1.44 4,154 ..............
and (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)..............................
Mammography facility certificate reinstatement 312 1 312 5 1,560 24,000,000
application--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 ..............
[[Page 36928]]
Notification of requirement to correct major 0.4 1 0.4 200 80 68
deficiencies--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)...........................................
-----------------------------------------------------------------------------------------------
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 2, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-13522 Filed 6-7-16; 8:45 am]
BILLING CODE 4164-01-P
