Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2023
I, General the Honourable David Hurley AC DSC (Retd), Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following regulations.
Dated 8 June 2023
David Hurley
Governor‑General
By His Excellency’s Command
Mark Butler
Minister for Health and Aged Care
Contents
1 Name
2 Commencement
3 Authority
4 Schedules
Schedule 1—Amendments
Therapeutic Goods (Medical Devices) Regulations 2002
Therapeutic Goods Regulations 1990
This instrument is the Therapeutic Goods Legislation Amendment (Fees and Other Measures) Regulations 2023.
(1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.
Commencement information | ||
Column 1 | Column 2 | Column 3 |
Provisions | Commencement | Date/Details |
1. The whole of this instrument | 1 July 2023. | 1 July 2023 |
Note: This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.
(2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.
This instrument is made under the Therapeutic Goods Act 1989.
Each instrument that is specified in a Schedule to this instrument is amended or repealed as set out in the applicable items in the Schedule concerned, and any other item in a Schedule to this instrument has effect according to its terms.
Therapeutic Goods (Medical Devices) Regulations 2002
1 After Part 8
Insert:
Part 8A—Waiver and refund of charges
In this Part:
charge year has the same meaning as in the Therapeutic Goods (Charges) Regulations 2018.
transitional medical device means a medical device of a kind mentioned in column 1 of an item in the following table if:
(a) the medical device was, immediately before 25 November 2021, included in the Register and classified as a class of medical device mentioned in column 2 of the item; or
(b) on 25 November 2021:
(i) the medical device was the subject of a class of application mentioned in column 2 of the item for inclusion in the Register; and
(ii) the application had not been finally determined.
Transitional medical device | ||
| Column 1 | Column 2 |
Item | Kind of medical device | Class of medical device or application |
1 | a medical device of a kind described in subclause 3.4(4B) of Schedule 2 | Class IIb |
2 | a medical device of a kind described in clause 5.10 of Schedule 2 | Class I or Class IIa |
3 | a medical device of a kind described in clause 5.11 of Schedule 2 | Class I, Class IIa or Class IIb |
4 | a medical device of a kind described in subclause 4.2(4) of Schedule 2 | Class IIa or Class IIb |
5 | a medical device of a kind described in subclause 3.2(3A) of Schedule 2 | Class IIa or Class IIb |
8A.2 Waiver of charges in relation to transitional medical devices
(1) This subregulation applies in relation to a kind of medical device if, at any time during a charge year:
(a) the medical device is a transitional medical device; and
(b) the entry for the kind of medical device in the Register does not include any medical device that is not a transitional medical device; and
(c) the medical device is included in the Register and classified both as:
(i) a class of medical device mentioned in column 2 of an item of the table in the definition of transitional medical device in regulation 8A.1; and
(ii) a class of medical device described in the provision mentioned in column 1 of that item; and
(d) the same kind of medical device is also listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, made under the Private Health Insurance Act 2007, as in force from time to time.
(2) The Secretary must, on behalf of the Commonwealth, waive the annual charge payable under the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of transitional medical device in the Register during the charge year if:
(a) the person liable to pay the charge applies for the charge to be waived for the charge year; and
(b) the application is made in the form (if any) approved, in writing, by the Secretary for the purposes of this subregulation; and
(c) the Secretary is reasonably satisfied that subregulation (1) applies in relation to the transitional medical device.
8A.3 Refund of certain charges in relation to transitional medical devices
(1) This subregulation applies in relation to a kind of medical device if, at any time during a charge year:
(a) the medical device is a transitional medical device; and
(b) the entry for the kind of medical device in the Register does not include any medical device that is not a transitional medical device; and
(c) the medical device is included in the Register and classified both as:
(i) a class of medical device mentioned in column 2 of an item of the table in the definition of transitional medical device in regulation 8A.1; and
(ii) a class of medical device described in the provision mentioned in column 1 of that item; and
(d) the same kind of medical device is also listed in the Private Health Insurance (Medical Devices and Human Tissue Products) Rules, made under the Private Health Insurance Act 2007, as in force from time to time; and
(e) the annual charge payable under the Therapeutic Goods (Charges) Act 1989 in respect of the inclusion of the kind of medical device in the Register during the charge year has been paid.
(2) The Secretary must, on behalf of the Commonwealth, refund an amount equal to the charge paid if:
(a) the person who paid the charge applies for the charge to be refunded; and
(b) the application is made in the form (if any) approved, in writing, by the Secretary for the purposes of this subregulation; and
(c) the Secretary is reasonably satisfied that subregulation (1) applies in relation to the transitional medical device.
2 Before paragraph 10.7(1A)(a)
Insert:
(aa) a decision to refuse to agree to an application under subregulation 8A.2(2) or 8A.3(2) for a waiver or refund of annual charge;
3 Part 1 of Schedule 5 (table item 1.10A)
Repeal the item, substitute:
1.10A | Conformity assessment—assessment because of changes or proposed changes to an IVD medical device or quality management system applying to that device, under conformity assessment procedures set out in: | Subsections 41LA(1) and (2) of the Act |
|
| (a) Schedule 3, Part 1—Full Quality Management System; or |
| 19,268 |
| (b) Schedule 3, clause 1.6—Design Examination; or |
| 41,060 |
| (c) Schedule 3, clause 1.6—Design Examination – Immunohaematology reagent medical devices; or |
| 9,973 |
| (d) Schedule 3, clause 1.6—Abridged Design Examination – previously registered IVDs; or |
| 2,419 |
| (e) Schedule 3, Part 2—Type Examination; or |
| 26,533 |
| (f) Schedule 3, Part 4—Production Quality Management System |
| 16,929 |
| Note 1: If a supplementary assessment, or an assessment outside Australia, is required, an additional fee is payable—see item 1.12 and clause 2.1 of this Schedule. |
|
|
| Note 2: For an assessment under Schedule 3, Part 2, an additional fee to cover the costs of testing the relevant kind of medical device, or quality management system, is also payable—see clause 2.2 of this Schedule. |
|
|
4 Part 1 of Schedule 5 (table items 1.14, 1.14A and 1.14B)
Repeal the items, substitute:
1.14 | Application audit assessment, Level 2—for Level 1 activities and review of evidence of conformity for the following kinds of medical device: | Subsections 41LA(3) and (4) of the Act |
|
| (a) Class III medical devices (other than IVD medical devices); |
| 16,000 |
| (b) all other medical devices (other than IVD medical devices) |
| 4,000 |
1.14A | Application audit assessment for the following kinds of medical devices: | Subsections 41LA(3) and (4) of the Act |
|
| (a) Class 1 and Class 2 IVD medical devices; |
| 7,387 |
| (b) Class 3 IVD medical devices; |
| 22,387 |
| (c) Class 4 IVD medical devices, other than: (i) Class 4 IVD medical devices that are immunohaematology reagent IVD medical devices; or (ii) devices to which item 1.14B or 1.14C applies; |
| 22,387 |
| (d) Class 4 IVD medical devices that are immunohaematology reagent IVD medical devices |
| 16,621 |
1.14B | Application audit assessment for Class 4 in‑house IVD medical devices (other than a device to which item 1.14C applies) | Subsections 41LA(3) and (4) of the Act | 22,387 |
5 Paragraph 2.1(b) of Part 2 of Schedule 5
Omit “$451”, substitute “$474”.
6 Amendments of listed provisions—Part 1 of Schedule 5
The items of the table in Part 1 of Schedule 5 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1.1 | 1,077 | 1,416 |
2 | Item 1.4A | 4,832 | 5,083 |
3 | Items 1.4B and 1.4C | 2,657 | 2,795 |
4 | Item 1.4D | 78,899 | 83,002 |
5 | Items 1.4E and 1.4F | 56,635 | 59,580 |
6 | Item 1.5, paragraph (e) | 1,098 | 575 |
7 | Item 1.5A | 10,568 | 11,118 |
8 | Item 1.6A, paragraphs (a) and (b) | 164 | 173 |
9 | Item 1.6A, paragraph (b) | 51 | 54 |
10 | Item 1.6B, paragraphs (a) and (b) | 164 | 173 |
11 | Item 1.6B, paragraph (b) | 51 | 54 |
Item 1.7 | 19,699 | 20,723 | |
13 | Item 1.7A | 5,376 | 5,656 |
14 | Item 1.8 | 390 | 410 |
14A | Item 1.12 | 451 | 474 |
15 | Item 1.13 | 4,135 | 4,350 |
16 | Item 1.15, paragraphs (a) and (b) | 513 | 540 |
17 | Item 1.15, paragraph (b) | 103 | 108 |
18 | Item 1.17 | 1,098 | 1,155 |
Therapeutic Goods Regulations 1990
7 Part 2 of Schedule 9 (table items 2A and 2AB)
Repeal the items, substitute:
2A | Fee for varying an entry in the Register (not including evaluation of data) under section 9D (other than subsection 9D(2C)) of the Act, if the variation is for: |
|
| (a) a registered medicine that is mentioned in Part 1 of Schedule 10—for each submission | 1,900 |
| (b) a listed medicine | 474 |
| (c) a disinfectant | 1,400 |
| (d) a Class 3 or Class 4 IVD medical device that is not covered by paragraph (g) | 1,750 |
| (e) an IVD medical device that is not: (i) a Class 3 or Class 4 IVD medical device; and (ii) covered by paragraph (g) | 1,000 |
| (f) a medical device that is not: (i) an IVD medical device; and (ii) covered by paragraph (g) | 1,000 |
| (g) a medical device, if the following are satisfied: (i) the reason for the variation is that the kind of medical device is affected by the EU transition (within the meaning of subregulation 9.1AA(3) of the Therapeutic Goods (Medical Devices) Regulations 2002); (ii) the variation only relates to an update to the manufacturer’s evidence for the medical device recorded in the entry in the Register for that kind of medical device; (iii) the request is to vary one or more entries in the Register and the manufacturer’s evidence to which the update relates is the same for each of the entries | 190 per 10 entries (or part thereof) |
8 Part 2 of Schedule 9 (table item 9B)
Repeal the item.
9 Amendments of listed provisions
The provisions listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Paragraph 43AAJ(1)(b) | 105,575 | 111,065 |
2 | Paragraph 43AC(2)(a) | 4,309 | 4,533 |
3 | Paragraph 43AC(2)(b) | 7,233 | 7,609 |
4 | Paragraph 43AC(2)(c) | 9,439 | 9,930 |
5 | Paragraph 43ACA(2)(aa) | 1,129 | 1,188 |
6 | Paragraph 43ACA(2)(ab) | 8,208 | 8,635 |
7 | Paragraph 43ACA(2)(a) | 4,350 | 4,576 |
8 | Paragraph 43ACA(2)(b) | 6,813 | 7,167 |
9 | Paragraph 43ACA(2)(c) | 10,065 | 10,588 |
10 | Paragraph 45(6)(a) | 1,180 | 1,241 |
11 | Paragraph 45(6)(b) | 4,709 | 4,954 |
10 Amendments of listed provisions—clause 3 of Schedule 9
The items of the table in clause 3 of Schedule 9 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1A, paragraphs (a) and (b) | 513 | 540 |
2 | Item 1A, paragraph (b) | 103 | 108 |
3 | Item 1, paragraph (a) | 1,857 | 1,954 |
4 | Item 1, paragraph (b) | 23,085 | 24,285 |
5 | Item 1AAA, paragraph (a) | 510 | 537 |
6 | Item 1AAA, paragraph (b) | 6,300 | 6,628 |
7 | Item 1AA | 13,441 | 14,140 |
8 | Item 1AB | 4,874 | 5,127 |
9 | Item 1ABA | 8,885 | 9,347 |
10 | Item 1AC, paragraph (a) | 51,710 | 54,399 |
11 | Item 1AC, paragraph (b) | 30,883 | 32,489 |
12 | Item 1AD, paragraph (a) | 269,838 | 283,870 |
13 | Item 1AD, paragraph (b) | 178,011 | 187,268 |
14 | Item 1AE | 30,780 | 32,381 |
15 | Item 1AF | 129,789 | 136,538 |
16 | Item 1AG | 18,571 | 19,537 |
17 | Item 1B | 13,441 | 14,140 |
18 | Item 2, paragraph (ba) | 51,608 | 54,292 |
19 | Item 2, paragraph (bb) | 17,134 | 18,025 |
20 | Item 2, paragraph (bc) | 34,371 | 36,158 |
21 | Item 2, paragraph (bca) | 54,686 | 57,530 |
22 | Item 2, paragraph (bd) | 30,780 | 32,381 |
23 | Item 2, subparagraph (be)(i) | 10,229 | 10,761 |
24 | Item 2, subparagraph (be)(ii) | 6,679 | 7,026 |
25 | Item 2, subparagraph (bf)(i) | 20,623 | 21,695 |
26 | Item 2, subparagraph (bf)(ii) | 13,338 | 14,032 |
27 | Item 2, paragraph (bfa) | 32,524 | 34,215 |
28 | Item 2, paragraph (bg) | 19,904 | 20,939 |
29 | Item 2, paragraph (bh) | 3,252 | 3,421 |
30 | Item 2, paragraph (bi) | 20,110 | 21,156 |
31 | Item 2, paragraphs (bj) and (bk) | 1,180 | 1,241 |
32 | Item 2, paragraph (c) | 4,699 | 4,943 |
33 | Item 2, paragraph (d) | 2,339 | 2,461 |
34 | Item 2, paragraph (d) | 13,646 | 14,356 |
35 | Item 2AC | 1,180 | 1,241 |
36 | Item 2B | 5,889 | 6,195 |
37 | Item 2C | 4,709 | 4,954 |
38 | Item 2CA | 5,889 | 6,195 |
39 | Items 2CB to 2CE (wherever occurring) | 862 | 907 |
40 | Item 3, paragraph (a) | 482 | 2,200 |
41 | Item 3, paragraph (b) | 893 | 939 |
42 | Item 3AB, paragraphs (a) and (b) | 451 | 474 |
43 | Item 3AB, paragraph (b) | 51 | 54 |
44 | Item 4, paragraph (a) | 206,842 | 217,598 |
45 | Item 4, subparagraphs (aa)(i) and (ii) | 69,050 | 72,641 |
46 | Item 4, subparagraph (aa)(iii) | 137,587 | 144,742 |
47 | Item 4, paragraph (ab) | 218,743 | 230,118 |
48 | Item 4, paragraph (b) | 122,710 | 129,091 |
49 | Item 4, subparagraph (bb)(i) | 40,937 | 43,066 |
50 | Item 4, subparagraph (bb)(i) | 26,573 | 27,955 |
51 | Item 4, subparagraph (bb)(ii) | 40,937 | 43,066 |
52 | Item 4, subparagraph (bb)(ii) | 26,573 | 27,955 |
53 | Item 4, subparagraph (bb)(iii) | 81,772 | 86,024 |
54 | Item 4, subparagraph (bb)(iii) | 53,455 | 56,235 |
55 | Item 4, paragraph (bc) | 4,709 | 4,954 |
56 | Item 4, paragraph (bd) | 130,097 | 136,862 |
57 | Item 4, paragraph (c) | 79,002 | 83,110 |
58 | Item 4, paragraph (d) | 12,928 | 13,600 |
59 | Item 4, paragraph (g) | 80,028 | 84,189 |
60 | Item 4, paragraph (h) | 4,709 | 4,954 |
61 | Item 6AA | 687 | 723 |
62 | Item 6AB | 739 | 777 |
63 | Item 6ABA | 2,627 | 2,764 |
64 | Item 6AC | 1,241 | 1,306 |
65 | Item 6B | 3,950 | 4,155 |
66 | Item 6BA, paragraphs (a) and (b) | 164 | 173 |
67 | Item 6BA, paragraph (b) | 51 | 54 |
68 | Item 6BB, paragraphs (a) and (b) | 164 | 173 |
69 | Item 6BB, paragraph (b) | 51 | 54 |
70 | Item 6C | 8,577 | 9,023 |
71 | Item 6D, paragraph (a) | 11,286 | 11,873 |
72 | Item 6D, paragraph (b) | 14,569 | 15,327 |
73 | Item 6D, paragraph (c) | 19,904 | 20,939 |
74 | Item 6D, paragraph (d) | 26,368 | 27,739 |
75 | Item 6D, paragraph (e) | 39,501 | 41,555 |
76 | Item 6D, paragraph (f) | 52,634 | 55,371 |
77 | Item 6D, paragraph (g) | 79,002 | 83,110 |
78 | Item 7A, paragraph (a) | 11,286 | 11,873 |
79 | Item 7A, subparagraph (b)(i) | 11,286 | 11,873 |
80 | Item 7A, subparagraph (b)(ii) | 14,569 | 15,327 |
81 | Item 7A, subparagraph (b)(iii) | 19,904 | 20,939 |
82 | Item 7A, subparagraph (b)(iv) | 26,368 | 27,739 |
83 | Item 7A, subparagraph (b)(v) | 39,501 | 41,555 |
84 | Item 7A, subparagraph (b)(vi) | 52,634 | 55,371 |
85 | Item 7A, subparagraph (b)(vii) | 79,002 | 83,110 |
86 | Item 7B, paragraph (a) | 11,286 | 11,873 |
87 | Item 7B, subparagraph (b)(i) | 11,286 | 11,873 |
88 | Item 7B, subparagraph (b)(ii) | 14,569 | 15,327 |
89 | Item 7B, subparagraph (b)(iii) | 19,904 | 20,939 |
90 | Item 7B, subparagraph (b)(iv) | 26,368 | 27,739 |
91 | Item 7B, subparagraph (b)(v) | 39,501 | 41,555 |
92 | Item 7B, subparagraph (b)(vi) | 52,634 | 55,371 |
93 | Item 7B, subparagraph (b)(vii) | 79,002 | 83,110 |
94 | Item 7C | 1,118 | 1,176 |
95 | Item 8, paragraph (a) | 841 | 885 |
96 | Item 8, paragraph (b) | 1,098 | 1,155 |
97 | Items 8A to 8C | 841 | 855 |
98 | Item 9, paragraph (a) | 1,047 | 1,101 |
99 | Item 9, paragraph (b) | 1,467 | 1,543 |
100 | Item 9AA | 718 | 755 |
101 | Item 9AB | 975 | 1,026 |
102 | Items 9AC and 9ACA | 718 | 755 |
103 | Item 9AD, paragraph (a) | 1,416 | 1,490 |
104 | Item 9AD, paragraph (b) | 12,004 | 12,628 |
105 | Item 9AD, paragraph (c) | 27,086 | 28,494 |
106 | Item 9AD, paragraph (d) | 36,423 | 38,317 |
107 | Item 9AD, paragraph (e) | 56,738 | 59,688 |
108 | Item 9AD, paragraph (f) | 75,616 | 79,548 |
109 | Item 9AD, paragraph (g) | 92,237 | 97,033 |
110 | Item 10 | 185 | 195 |
111 | Item 14, paragraphs (a) and (b) | 390 | 410 |
112 | Item 18 | 2,380 | 2,504 |
11 Amendments of listed provisions—clause 4 of Schedule 9
The items of the table in clause 4 of Schedule 9 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1, paragraphs (a) and (b) | 1,744 | 1,835 |
2 | Item 1, paragraph (c) | 2,801 | 2,947 |
3 | Item 1, paragraph (d) | 4,094 | 4,307 |
4 | Item 1, paragraph (e) | 6,064 | 6,379 |
5 | Item 1, paragraphs (f) to (h) | 1,744 | 1,835 |
6 | Item 1, paragraph (i) | 2,801 | 2,947 |
7 | Item 2, paragraph (a) | 4,309 | 4,533 |
8 | Item 2, paragraph (b) | 6,125 | 6,444 |
9 | Item 2, paragraph (c) | 9,439 | 9,930 |
10 | Item 2, paragraph (d) | 15,698 | 16,514 |
11 | Item 2, paragraph (e) | 23,085 | 24,285 |
12 | Item 2, paragraph (f) | 4,309 | 4,533 |
13 | Item 2, paragraph (g) | 7,233 | 7,609 |
14 | Item 2, paragraph (h) | 9,439 | 9,930 |
15 | Item 3, paragraphs (d) and (e) | 882 | 928 |
16 | Item 3, paragraphs (f) to (h) | 1,406 | 1,479 |
17 | Item 4, paragraphs (d) to (f) | 4,781 | 5,030 |
18 | Item 5, paragraph (a) | 1,744 | 1,835 |
19 | Item 5, paragraph (b) | 6,064 | 6,379 |
20 | Item 5, paragraph (c) | 8,988 | 9,455 |
21 | Item 5, paragraph (d) | 12,209 | 12,844 |
22 | Item 7, paragraph (a) | 1,713 | 1,802 |
23 | Item 7, paragraph (b) | 8,783 | 9,240 |
12 Amendments of listed provisions—clause 5 of Schedule 9
The items of the table in clause 5 of Schedule 9 listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Item 1A | 2,103 | 2,212 |
2 | Item 1B | 9,183 | 9,661 |
3 | Item 1C | 841 | 885 |
4 | Items 1D and 1E | 975 | 1,026 |
5 | Item 1F | 841 | 885 |
6 | Item 1G | 1,129 | 1,188 |
7 | Item 1H | 8,208 | 8,635 |
8 | Item 1 | 1,529 | 1,609 |
9 | Item 2 | 5,161 | 5,429 |
10 | Item 3 | 7,664 | 8,063 |
11 | Item 4 | 10,876 | 11,442 |
12 | Item 5 | 1,529 | 1,609 |
13 | Item 6 | 800 | 842 |
14 | Item 7 | 4,350 | 4,576 |
15 | Item 8 | 862 | 907 |
16 | Item 9 | 6,813 | 7,167 |
17 | Item 10 | 882 | 928 |
18 | Item 11 | 10,065 | 10,588 |
19 | Item 12 | 585 | 615 |
20 | Item 13 | 3,355 | 3,529 |
21 | Item 14 | 2,103 | 2,212 |
22 | Item 15 | 22,469 | 23,637 |
23 | Item 16 | 2,103 | 2,212 |
24 | Item 17 | 22,469 | 23,637 |
25 | Item 18 | 2,780 | 2,925 |
26 | Item 19 | 30,575 | 32,165 |
27 | Item 20 | 3,047 | 3,205 |
28 | Item 21 | 38,988 | 41,015 |
29 | Item 22 | 472 | 497 |
30 | Item 23 | 1,796 | 1,889 |
31 | Item 24 | 1,939 | 2,040 |
32 | Item 25 | 14,877 | 15,651 |
33 | Item 26 | 1,939 | 2,040 |
34 | Item 27 | 14,877 | 15,651 |
35 | Item 28 | 1,149 | 1,209 |
36 | Item 29 | 15,493 | 16,299 |
37 | Item 30 | 1,149 | 1,209 |
38 | Item 31 | 15,493 | 16,299 |
39 | Item 32 | 3,047 | 3,205 |
40 | Item 33 | 25,240 | 26,552 |
41 | Item 34 | 3,047 | 3,205 |
42 | Item 35 | 25,240 | 26,552 |
13 Amendments of listed provisions—Part 2 of Schedule 9A
The items of the table in Part 2 of Schedule 9A listed in the following table are amended as set out in the table.
Amendments relating to fees | |||
Item | Provision | Omit | Substitute |
1 | Items 1 and 2 | 1,170 | 1,231 |
2 | Item 2A | 13,971 | 14,697 |
3 | Item 3 | 1,170 | 1,231 |
4 | Item 3A, paragraphs (a) and (b) | 451 | 474 |
5 | Item 3A, paragraph (b) | 51 | 54 |
6 | Item 4, paragraph (a) | 81,397 | 85,630 |
7 | Item 4, paragraph (b) | 77,873 | 81,922 |
8 | Item 5, paragraph (a) | 163,197 | 171,683 |
9 | Item 5, paragraph (b) | 155,849 | 163,953 |
10 | Item 6, paragraph (a) | 263,710 | 277,423 |
11 | Item 6, paragraph (b) | 253,217 | 266,384 |
12 | Item 7 | 25,342 | 26,660 |
13 | Item 8 | 1,170 | 1,231 |
14 | Items 8A and 9 | 7,141 | 7,512 |
15 | Item 10 | 18,776 | 19,752 |
16 | Item 11 | 36,936 | 38,857 |
17 | Item 11A, paragraphs (a) and (b) | 513 | 540 |
18 | Item 11A, paragraph (b) | 103 | 108 |
19 | Item 12 | 23,085 | 24,285 |
20 | Item 13 | 17,545 | 18,457 |
21 | Item 14 | 718 | 755 |
22 | Item 16 | 28,112 | 29,574 |
23 | Item 16AA | 7,670 | 8,069 |
24 | Item 16A, paragraphs (a) and (b) | 164 | 173 |
25 | Item 16A, paragraph (b) | 51 | 54 |
26 | Item 16B, paragraphs (a) and (b) | 164 | 173 |
27 | Item 16B, paragraph (b) | 51 | 54 |
28 | Item 17, paragraphs (a) and (b) | 390 | 410 |