Ethyl 3,3-di-(tert-              UN3106                    <=52  ........  ........      >=48  .........  OP7            ........  ...........  ........
 butylperoxy)butyrate.
1-(2-ethylhexanoylperoxy)-1,3-   UN3115                    <=52      >=45      >=10  ........  .........  OP7                 -20          -10  ........
 Dimethylbutyl peroxypivalate.
tert-Hexyl peroxyneodecanoate..  UN3115                    <=71      >=29  ........  ........  .........  OP7                   0           10  ........
tert-Hexyl peroxypivalate......  UN3115                    <=72  ........      >=28  ........  .........  OP7                  10           15  ........
3-Hydroxy-1,1-dimethylbutyl      UN3115                    <=77      >=23  ........  ........  .........  OP7                  -5            5  ........
 peroxyneodecanoate.
3-Hydroxy-1,1-dimethylbutyl      UN3119                    <=52  ........  ........  ........  .........  OP8                  -5            5  ........
 peroxyneodecanoate [as a
 stable dispersion in water].
3-Hydroxy-1,1-dimethylbutyl      UN3117                    <=52      >=48  ........  ........  .........  OP8                  -5            5  ........
 peroxyneodecanoate.
Isopropyl sec-butyl              UN3111           <=52 + <=28 +  ........  ........  ........  .........  OP5                 -20          -10  ........
 peroxydicarbonat + Di-sec-                                <=22
 butyl peroxydicarbonate + Di-
 isopropyl peroxydicarbonate.
Isopropyl sec-butyl              UN3115         <=32 + <=15 -18      >=38  ........  ........  .........  OP7                 -20          -10  ........
 peroxydicarbonate + Di-sec-                         + <=12 -15
 butyl peroxydicarbonate + Di-
 isopropyl peroxydicarbonate.
Isopropylcumyl hydroperoxide...  UN3109                    <=72      >=28  ........  ........  .........  OP8            ........  ...........        13
p-Menthyl hydroperoxide........  UN3105                 >72-100  ........  ........  ........  .........  OP7            ........  ...........        13
p-Menthyl hydroperoxide........  UN3109                    <=72      >=28  ........  ........  .........  OP8            ........  ...........  ........
Methylcyclohexanone peroxide(s)  UN3115                    <=67  ........      >=33  ........  .........  OP7                  35           40  ........
Methyl ethyl ketone peroxide(s)  UN3101                    <=52      >=48  ........  ........  .........  OP5            ........  ...........     5, 13
Methyl ethyl ketone peroxide(s)  UN3105                    <=45      >=55  ........  ........  .........  OP7            ........  ...........         5
Methyl ethyl ketone peroxide(s)  UN3107                    <=40      >=60  ........  ........  .........  OP8            ........  ...........         7
Methyl isobutyl ketone           UN3105                    <=62      >=19  ........  ........  .........  OP7            ........  ...........     5, 23
 peroxide(s).
Methyl isopropyl ketone          UN3109         (See remark 31)      >=70  ........  ........  .........  OP8            ........  ...........        31
 peroxide(s).
Organic peroxide, liquid,        UN3103         ...............  ........  ........  ........  .........  OP2            ........  ...........        12
 sample.
Organic peroxide, liquid,        UN3113         ...............  ........  ........  ........  .........  OP2            ........  ...........        12
 sample, temperature controlled.
Organic peroxide, solid, sample  UN3104         ...............  ........  ........  ........  .........  OP2            ........  ...........        12
Organic peroxide, solid,         UN3114         ...............  ........  ........  ........  .........  OP2            ........  ...........        12
 sample, temperature controlled.
3,3,5,7,7-Pentamethyl-1,2,4-     UN3107                   <=100  ........  ........  ........  .........  OP8            ........  ...........  ........
 Trioxepane.
Peroxyacetic acid, type D,       UN3105                    <=43  ........  ........  ........  .........  OP7            ........  ...........    13, 20
 stabilized.
Peroxyacetic acid, type E,       UN3107                    <=43  ........  ........  ........  .........  OP8            ........  ...........    13, 20
 stabilized.
Peroxyacetic acid, type F,       UN3109                    <=43  ........  ........  ........  .........  OP8            ........  ...........   13, 20,
 stabilized.                                                                                28
Peroxyacetic acid or peracetic   UN3107                    <=36  ........  ........  ........       >=15  OP8            ........  ...........   13, 20,
 acid [with not more than 7%                                                                                28
 hydrogen peroxide].
Peroxyacetic acid or peracetic   Exempt                     <=6  ........  ........  ........       >=60  Exempt         ........  ...........        28
 acid [with not more than 20%
 hydrogen peroxide].
Peroxyacetic acid or peracetic   UN3109                    <=17  ........  ........  ........  .........  OP8            ........  ...........   13, 20,
 acid [with not more than 26%                                                                                28
 hydrogen peroxide].
Peroxylauric acid..............  UN3118                   <=100  ........  ........  ........  .........  OP8                  35           40  ........
1-Phenylethyl hydroperoxide....  UN3109                    <=38  ........      >=62  ........  .........  OP8            ........  ...........  ........
Pinanyl hydroperoxide..........  UN3105                 >56-100  ........  ........  ........  .........  OP7            ........  ...........        13
Pinanyl hydroperoxide..........  UN3109                    <=56      >=44  ........  ........  .........  OP8            ........  ...........  ........
Polyether poly-tert-             UN3107                    <=52  ........      >=48  ........  .........  OP8            ........  ...........  ........
 butylperoxycarbonate.

Tetrahydronaphthyl               UN3106                   <=100  ........  ........  ........  .........  OP7            ........  ...........  ........
 hydroperoxide.
1,1,3,3-Tetramethylbutyl         UN3105                   <=100  ........  ........  ........  .........  OP7            ........  ...........  ........
 hydroperoxide.
1,1,3,3-Tetramethylbutyl peroxy- UN3115                   <=100  ........  ........  ........  .........  OP7                  15           20  ........
 2-ethylhexanoate.
1,1,3,3-Tetramethylbutyl         UN3115                    <=72  ........      >=28  ........  .........  OP7                  -5            5  ........
 peroxyneodecanoate.
1,1,3,3-Tetramethylbutyl         UN3119                    <=52  ........  ........  ........  .........  OP8                  -5            5  ........
 peroxyneodecanoate [as a
 stable dispersion in water].
1,1,3,3-tetramethylbutyl         UN3115                    <=77      >=23  ........  ........  .........  OP7                   0           10  ........
 peroxypivalate.
3,6,9-Triethyl-3,6,9-trimethyl-  UN3110                    <=17      >=18  ........      >=65  .........  OP8            ........  ...........  ........
 1,4,7-triperoxonane.
3,6,9-Triethyl-3,6,9-trimethyl-  UN3105                    <=42      >=58  ........  ........  .........  OP7            ........  ...........        26
 1,4,7-triperoxonane.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes:
1. For domestic shipments, OP8 is authorized.
2. Available oxygen must be <4.7%.
3. For concentrations <80% OP5 is allowed. For concentrations of at least 80% but <85%, OP4 is allowed. For concentrations of at least 85%, maximum
  package size is OP2.
4. The diluent may be replaced by di-tert-butyl peroxide.
5. Available oxygen must be <=9% with or without water.
6. For domestic shipments, OP5 is authorized.
7. Available oxygen must be <=8.2% with or without water.
8. Only non-metallic packagings are authorized.
9. For domestic shipments this material may be transported under the provisions of paragraph (h)(3)(xii) of this section.
10. [Reserved]
11. [Reserved]
12. Samples may only be offered for transportation under the provisions of paragraph (b)(2) of this section.
13. ``Corrosive'' subsidiary risk label is required.
14. [Reserved]
15. No ``Corrosive'' subsidiary risk label is required for concentrations below 80%.
16. With <6% di-tert-butyl peroxide.
17. With <=8% 1-isopropylhydroperoxy-4-isopropylhydroxybenzene.
18. Addition of water to this organic peroxide will decrease its thermal stability.
19. [Reserved]
20. Mixtures with hydrogen peroxide, water and acid(s).
21. With diluent type A, with or without water.
22. With >=36% diluent type A by mass, and in addition ethylbenzene.
23. With >=19% diluent type A by mass, and in addition methyl isobutyl ketone.
24. Diluent type B with boiling point >100 C.
25. No ``Corrosive'' subsidiary risk label is required for concentrations below 56%.
26. Available oxygen must be <=7.6%.
27. Formulations derived from distillation of peroxyacetic acid originating from peroxyacetic acid in a concentration of not more than 41% with water,
  total active oxygen less than or equal to 9.5% (peroxyacetic acid plus hydrogen peroxide).
28. For the purposes of this section, the names ``Peroxyacetic acid'' and ``Peracetic acid'' are synonymous.
29. Not subject to the requirements of this subchapter for Division 5.2.
30. Diluent type B with boiling point >130 [deg]C (266 [deg]F).
31. Available oxygen <=6.7%.

    (d) * * *
    (4) * * *

Table to Paragraph (d): Maximum Quantity per Packaging/Package

* * * * *
    (e) Organic Peroxide IBC Table. The following Organic Peroxide IBC
Table specifies, by technical name, those organic peroxides that are
authorized for transportation in certain IBCs and not subject to the
approval provisions of Sec.  173.128 of this part. The formulations
listed below may also be transported packed in accordance with packing
method OP8 of this section, with the same control and emergency
temperatures, if applicable. Additional requirements for authorized
IBCs are found in paragraph (f) of this section.

                               Table to Paragraph (e): Organic Peroxide IBC Table
----------------------------------------------------------------------------------------------------------------
                                                                      Maximum
      UN No.         Organic peroxide          Type of IBC           quantity         Control        Emergency
                                                                     (liters)       temperature     temperature
----------------------------------------------------------------------------------------------------------------
3109.............  ORGANIC PEROXIDE,     .......................  ..............  ..............  ..............
                    TYPE F, LIQUID..
                   tert-Butyl cumyl      31HA1                             1,000  ..............  ..............
                    peroxide.
                   tert-Butyl            31A                               1,250  ..............  ..............
                    hydroperoxide, not
                    more than 72% with
                    water.
                                         31HA1                             1,000  ..............  ..............
                   tert-Butyl            31A                               1,250  ..............  ..............
                    peroxyacetate, not
                    more than 32% in
                    diluent type A.
                                         31HA1                             1,000  ..............  ..............
                   tert-Butyl            31A                               1,250  ..............  ..............
                    peroxybenzoate, not
                    more than 32% in
                    diluent type A.
                   tert-Butyl peroxy-    31A                               1,250  ..............  ..............
                    3,5,5-
                    trimethylhexanoate,
                    not more than 37%
                    in diluent type A.
                                         31HA1                             1,000  ..............  ..............
                   Cumyl hydroperoxide,  31HA1                             1,250  ..............  ..............
                    not more than 90%
                    in diluent type A.
                   Dibenzoyl peroxide,   31H1                              1,000  ..............  ..............
                    not more than 42%
                    as a stable
                    dispersion.

                   2,5-Dimethyl-2,5-     31HA1                             1,000  ..............  ..............
                    di(tert-
                    butylperoxy)hexane,
                    not more than 52%
                    in diluent type A.
                   Di-tert-butyl         31A                               1,250  ..............  ..............
                    peroxide, not more
                    than 52% in diluent
                    type B.
                                         31HA1                             1,000  ..............  ..............
                   1,1-Di-(tert-         31A                               1,250  ..............  ..............
                    Butylperoxy)
                    cyclohexane, not
                    more than 37% in
                    diluent type A.
                   1,1-Di-(tert-         31H1                              1,000  ..............  ..............
                    butylperoxy)
                    cyclohexane, not
                    more than 42% in
                    diluent type A.
                   Dicumyl peroxide,     31A                               1,250  ..............  ..............
                    less than or equal
                    to 100%.
                                         31HA1                             1,000  ..............  ..............
                   Dilauroyl peroxide,   31HA1                             1,000  ..............  ..............
                    not more than 42%,
                    stable dispersion,
                    in water.
                   Isopropyl cumyl       31HA1                             1,250  ..............  ..............
                    hydroperoxide, not
                    more than 72% in
                    diluent type A.
                   p-Menthyl             31HA1                             1,250  ..............  ..............
                    hydroperoxide, not
                    more than 72% in
                    diluent type A.
                   Peroxyacetic acid,    31A                               1,500  ..............  ..............
                    stabilized, not
                    more than 17%.
                                         31H1                              1,500  ..............  ..............
                                         31H2                              1,500  ..............  ..............
                                         31HA1                             1,500  ..............  ..............
                   Peroxyacetic acid,    31A                               1,500  ..............  ..............
                    not more than 26%
                    hydrogen peroxide.
                                         31HA1                             1,500  ..............  ..............
                   Peroxyacetic acid,    31A                               1,500  ..............  ..............
                    type F, stabilized.
                                         31HA1                             1,500  ..............  ..............
                   3,6,9-Triethyl-3,6,9- 31HA1                             1,000  ..............  ..............
                    trimethyl-,4,7-
                    triperoxonane not
                    more than 27%
                    diluent type A.
3110.............  ORGANIC PEROXIDE      .......................  ..............  ..............  ..............
                    TYPE F, SOLID..
                   Dicumyl peroxide,     31A                                2000  ..............  ..............
                    less than or equal
                    to 100%.
                                         31H1                     ..............  ..............  ..............
                                         31HA1                    ..............  ..............  ..............
3119.............  ORGANIC PEROXIDE,     .......................  ..............  ..............  ..............
                    TYPE F, LIQUID,
                    TEMPERATURE
                    CONTROLLED.
                   tert-Amyl peroxy-2-   31HA1                             1,000     +15 [ordm]C     +20 [ordm]C
                    ethylhexanoate, not
                    more than 62% in a
                    diluent type A.
                   tert-Amyl             31A                               1,250      +10 [deg]C      +15 [deg]C
                    peroxypivalate, not
                    more than 32% in
                    diluent type A.
                   tert-Butyl peroxy-2-  31HA1                             1,000      +30 [deg]C      +35 [deg]C
                    ethylhexanoate, not
                    more than 32% in
                    diluent type B.
                                         31A                               1,250      +30 [deg]C      +35 [deg]C
                   tert-Butyl            31A                               1,250        0 [deg]C      +10 [deg]C
                    peroxyneodecanoate,
                    not more than 32%
                    in diluent type A.
                   tert-Butyl            31A                               1,250       -5 [deg]C       +5 [deg]C
                    peroxyneodecanoate,
                    not more than 52%,
                    stable dispersion,
                    in water.
                   tert-Butyl            31HA1                             1,000      +10 [deg]C      +15 [deg]C
                    peroxypivalate, not
                    more than 27% in
                    diluent type B.
                                         31A                               1,250      +10 [deg]C      +15 [deg]C
                   Cumyl                 31A                               1,250      -15 [deg]C       -5 [deg]C
                    peroxyneodecanoate,
                    not more than 52%,
                    stable dispersion,
                    in water.
                   Di-(4-tert-           31HA1                             1,000      +30 [deg]C      +35 [deg]C
                    butylcyclohexyl)
                    peroxydicarbonate,
                    not more than 42%,
                    stable dispersion,
                    in water.
                   Dicetyl               31HA1                             1,000      +30 [deg]C      +35 [deg]C
                    peroxydicarbonate,
                    not more than 42%,
                    stable dispersion,
                    in water.
                   Dicyclohexylperoxydi  31A                               1,250      +10 [deg]C      +15 [deg]C
                    carbonate, not more
                    than 42% as a
                    stable dispersion,
                    in water.
                   Di-(2-ethylhexyl)     31A                               1,250      -20 [deg]C      -10 [deg]C
                    peroxydicarbonate,
                    not more than 62%,
                    stable dispersion,
                    in water.
                                         31HA1                             1,000     -20 [ordm]C     -10 [ordm]C
                   Diisobutyryl          31HA1                             1,000      -20 [deg]C      -10 [deg]C
                    peroxide, not more
                    than 28% as a
                    stable dispersion
                    in water.
                                         31A                               1,250      -20 [deg]C      -10 [deg]C
                   Diisobutyryl          31HA1                             1,000      -25 [deg]C      -15 [deg]C
                    peroxide, not more
                    than 42% as a
                    stable dispersion
                    in water.
                                         31A                               1,250      -25 [deg]C      -15 [deg]C
                   Dimyristyl            31HA1                             1,000      +15 [deg]C      +20 [deg]C
                    peroxydicarbonate,
                    not more than 42%,
                    stable dispersion,
                    in water.
                   Di-(2-                31A                               1,250      -15 [deg]C       -5 [deg]C
                    neodecanoylperoxyis
                    opropyl) benzene,
                    not more than 42%,
                    stable dispersion,
                    in water.
                   Di-(3,5,5-            31HA1                             1,000      +10 [deg]C      +15 [deg]C
                    trimethylhexanoyl)
                    peroxide, not more
                    than 52% in diluent
                    type A.
                                         31A                               1,250      +10 [deg]C      +15 [deg]C
                   Di-(3,5,5-            31A                               1,250      +10 [deg]C      +15 [deg]C
                    trimethylhexanoyl)
                    peroxide, not more
                    than 52%, stable
                    dispersion, in
                    water.

                   3-Hydroxy-1,1-        31A                               1,250      -15 [deg]C       -5 [deg]C
                    dimethylbutyl
                    peroxy-
                    neodecanoate, not
                    more than 52%,
                    stable dispersion,
                    in water.
                   1,1,3,3-              31HA1                             1,000     +15 [ordm]C     +20 [ordm]C
                    Tetramethylbutyl
                    peroxy-2-
                    ethylhexanoate, not
                    more than 67%, in
                    diluent type A.
                   1,1,3,3-              31A                               1,250       -5 [deg]C       +5 [deg]C
                    Tetramethylbutyl
                    peroxyneodecanoate,
                    not more than 52%,
                    stable dispersion,
                    in water.
                                         31HA1                             1,000       -5 [deg]C       +5 [deg]C
----------------------------------------------------------------------------------------------------------------

* * * * *
    (g) Organic Peroxide Portable Tank Table. The following Organic
Peroxide Portable Tank Table provides certain portable tank
requirements and identifies, by technical name, those organic peroxides
that are authorized for transportation in the bulk packagings listed in
paragraph (h). Organic peroxides listed in this table, provided they
meet the specific packaging requirements found in paragraph (h), are
not subject to the approval provisions of Sec.  173.128 of this part.
In addition, the formulations listed below may also be transported
packed in accordance with packing method OP8 of this section, with the
same control and emergency temperatures, if applicable.

Table to Paragraph (g): Organic Peroxide Portable Tank Table

* * * * *
0
28. Section 173.232 is added to subpart E to read as follows:

Sec.  173.232   Articles containing hazardous materials, n.o.s.

    (a) Articles containing hazardous materials may be classified as
otherwise provided by this subchapter under the proper shipping name
for the hazardous materials they contain or in accordance with this
section. For the purposes of this section, ``article'' means machinery,
apparatus, or other devices containing one or more hazardous materials
(or residues thereof) that are an integral element of the article,
necessary for its functioning, and that cannot be removed for the
purpose of transport. An inner packaging is not an article. For
articles that do not have an existing proper shipping name and that
contain only hazardous materials within the permitted limited quantity
amounts specified in column (8A) of the Sec.  172.101 Table, see
UN3363, Dangerous goods in machinery or apparatus, as prescribed in
Sec.  172.102(c)(1), Special provision 136, and Sec.  173.222.
    (b) Such articles may contain batteries. Lithium batteries that are
integral to the article must be of a type proven to meet the testing
requirements of the UN Manual of Tests and Criteria, Part III,
subsection 38.3 (IBR, see Sec.  171.7 of this subchapter), except when
otherwise specified by this subchapter.
    (c) This section does not apply to articles for which a more
specific proper shipping name already exists in the Sec.  172.101
Table. This section does not apply to hazardous materials of Class 1,
Division 6.2, Class 7, or radioactive material contained in articles.
    (d) Articles containing hazardous materials must be assigned to the
appropriate class or division determined by the hazards present using,
where applicable, the precedence criteria prescribed in Sec.  173.2a
for each of the hazardous materials contained in the article. If
hazardous materials classified as Class 9 are contained within the
article, all other hazardous materials present in the article must be
considered to present a higher hazard.
    (e) Subsidiary hazards must be representative of the primary hazard
posed by the other hazardous materials contained within the article.
When only one item of hazardous materials is present in the article,
the subsidiary hazard(s), if any, is the subsidiary hazard(s)
identified in column 6 of the Sec.  172.101 Table. If the article
contains more than one item of hazardous materials and these could
react dangerously with one another during transport, each of the
hazardous materials must be enclosed separately.
    (f)(1) Packagings must conform to the Packing Group II performance
level. The following packagings are authorized:
    (i) Drums (1A2, 1B2, 1N2, 1H2, 1D, 1G);
    (ii) Boxes (4A, 4B, 4N, 4C1, 4C2, 4D, 4F, 4G, 4H1, 4H2); and
    (iii) Jerricans (3A2, 3B2, 3H2).
    (2) In addition, for robust articles, the following non-
specification packagings are authorized:
    (i) Strong outer packagings constructed of suitable material and of
adequate strength and design in relation to the packaging capacity and
its intended use. Each package must conform to the packaging
requirements of subpart B of this part, except for the requirements in
Sec. Sec.  173.24(a)(1) and 173.27(e).
    (ii) Articles may be transported unpackaged or on pallets when the
hazardous materials are afforded equivalent protection by the article
in which they are contained.
    (g) The nature of the containment must be as follows--
    (1) In the event of damage to the receptacles containing the
hazardous materials, no leakage of the hazardous materials from the
machinery or apparatus is possible. A leakproof liner may be used to
satisfy this requirement.
    (2) Receptacles containing hazardous materials must be secured and
cushioned so as to prevent their breakage or leakage and to control
their movement within the machinery or apparatus during normal
conditions of transportation. Cushioning material must not react
dangerously with the content of the receptacles. Any leakage of the
contents must not substantially impair the protective properties of the
cushioning material.
    (3) Receptacles for gases, their contents, and filling densities
must conform to the applicable requirements of this subchapter, unless
otherwise approved by the Associate Administrator.

0
29. In Sec.  173.301b paragraphs (c)(1) and (d)(1) are revised to read
as follow:

Sec.  173.301b  Additional general requirements for shipment of UN
pressure receptacles.

* * * * *
    (c) * * *
    (1) When the use of a valve is prescribed, the valve must conform
to the requirements in ISO 10297:2014(E) (IBR, see Sec.  171.7 of this
subchapter). Quick release cylinder valves for specification and type
testing must conform to the requirements in ISO 17871:2015(E) Gas
cylinders--Quick-release cylinder valves--Specification and type
testing (IBR, see Sec.  171.7 of this subchapter). Until December 31,
2020, the manufacture of a valve conforming to the requirements in ISO
10297:2006(E) is authorized. Until

December 31, 2008, the manufacture of a valve conforming to the
requirements in ISO 10297:1999(E) (IBR, see Sec.  171.7 of this
subchapter) is authorized.
* * * * *
    (d) * * *
    (1) When the use of a valve is prescribed, the valve must conform
to the requirements in ISO 11118:2015(E), (IBR, see Sec.  171.7 of this
subchapter). Manufacture of valves to ISO 13340:2001(E) is authorized
until December 31, 2020;
* * * * *
0
30. In Sec.  173.304b, paragraph (b)(5) is revised to read as follows:

Sec.  173.304b  Additional requirements for shipment of liquefied
compressed gases in UN pressure receptacles.

* * * * *
    (b) * * *
    (5) For liquefied gases charged with compressed gases, both
components--the liquefied gas and the compressed gas--must be taken
into consideration in the calculation of the internal pressure in the
pressure receptacle. The maximum mass of contents per liter of water
capacity shall not exceed 95 percent of the density of the liquid phase
at 50 [deg]C (122 [deg]F); in addition, the liquid phase shall not
completely fill the pressure receptacle at any temperature up to 60
[deg]C (140 [deg]F). When filled, the internal pressure at 65 [deg]C
(149 [deg]F) shall not exceed the test pressure of the pressure
receptacles. The vapor pressures and volumetric expansions of all
substances in the pressure receptacles shall be considered. The maximum
filling limits may be determined using the procedure in (3)(e) of P200
of the UN Recommendations.
* * * * *
0
31. In, Sec.  173.422 paragraphs (d) and (e) are revised and paragraph
(f) is added to read as follows:

Sec.  173.422  Additional requirements for excepted packages containing
Class 7 (radioactive) materials.

* * * * *
    (d) The training requirements of subpart H of part 172 of this
subchapter;
    (e) For a material that meets the definition of a hazardous
substance or a hazardous waste, the shipping paper requirements of
subpart C of part 172 of this subchapter, except that such shipments
are not subject to shipping paper requirements applicable to Class 7
(radioactive) materials in Sec. Sec.  172.202(a)(5), 172.202(a)(6),
172.203(d) and 172.204(c)(4); and
    (f) For transportation by vessel--
    (1) The following information must be shown on a special transport
document such as a bill of lading, air waybill, or other similar
document:
    (i) The UN identification number for the material preceded by the
letters ``UN'', as shown in column (4) of the Hazardous Materials Table
in Sec.  172.101 of this subchapter; and
    (ii) The name and address of the consignor and the consignee.
    (2) The certificate requirements in Sec.  176.27 must be met.
0
32. Add appendix I to part 173 to read as follows:

Appendix I to Part 173--Calculation Method
[GRAPHIC] [TIFF OMITTED] TP27NO18.003

PART 174--CARRIAGE BY RAIL

0
33. The authority citation for part 174 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128; 49 CFR 1.81 and 1.97.

0
34. Revise Sec.  174.50 to read as follows:

Sec.  174.50  Nonconforming or leaking packages.

    A leaking non-bulk package may not be forwarded until repaired,
reconditioned, or overpacked in

accordance with Sec.  173.3 of this subchapter. Except as otherwise
provided in this section, a bulk packaging that no longer conforms to
this subchapter may not be forwarded by rail unless repaired or
approved for movement by the Associate Administrator for Safety,
Federal Railroad Administration, or for cross-border movements to or
from Canada, moved in accordance with the TDG Regulations (see Sec.
171.12) or a Temporary Certificate issued by the Competent Authority of
Canada, as applicable. For FRA Approval, notification and approval must
be in writing, or through telephonic or electronic means, with
subsequent written confirmation provided within two weeks. For the
applicable address and telephone number, see Sec.  107.117(d)(4) of
this chapter. A leaking bulk package containing a hazardous material
may be moved without repair or approval only so far as necessary to
reduce or to eliminate an immediate threat or harm to human health or
to the environment when it is determined its movement would provide
greater safety than allowing the package to remain in place. In the
case of a liquid leak, measures must be taken to prevent the spread of
liquid.

PART 175--CARRIAGE BY AIRCRAFT

0
35. The authority citation for part 175 continues to read as follows:

    Authority: 49 U.S.C. 5101-5128, 44701; 49 CFR 1.81 and 1.97.

0
36. In Sec.  175.10, revise paragraphs (a)(2) and (3), (a)(14) and
(15), (a)(17)(v) introductory text, and (a)(18) and (19), and add
paragraph (a)(26) to read as follows:

Sec.  175.10  Exceptions for passengers, crewmembers, and air
operators.

    (a) * * *
    (2) One packet of safety matches or a lighter intended for use by
an individual when carried on one's person or in carry-on baggage only.
Lighter fuel, lighter refills, and lighters containing unabsorbed
liquid fuel (other than liquefied gas) are not permitted on one's
person or in carry-on or checked baggage. For lighters powered by
lithium batteries (e.g., laser plasma lighters, tesla coil lighters,
flux lighters, arc lighters and double arc lighters), each battery must
be of a type which meets the requirements of each test in the UN Manual
of Tests and Criteria, Part III, Subsection 38.3. Measures must be
taken to prevent unintentional activation of the heating element while
on board the aircraft. Recharging of the devices and/or the batteries
on board the aircraft is not permitted. Each battery must not exceed
the following:
    (i) For lithium metal batteries, a lithium content of 2 grams; or
    (ii) For lithium ion batteries, a Watt-hour (Wh) rating of 100 Wh.
    (3) Implanted or externally fitted medical devices in humans or
animals that contain radioactive materials (e.g., cardiac pacemaker),
as the result of medical treatment; and radiopharmaceuticals that have
been injected or ingested.
* * * * *
    (14) Battery powered heat-producing devices (e.g., battery-operated
equipment such as diving lamps and soldering equipment) as checked or
carry-on baggage and with the approval of the operator of the aircraft.
The heating element, the battery, or other component (e.g., fuse) must
be isolated to prevent unintentional activation during transport. Any
battery that is removed must be carried in accordance with the
provisions for spare batteries in paragraph (a)(18) of this section.
    Each installed or spare lithium battery:
    (i) For a lithium metal battery, a lithium content must not exceed
2 grams; or
    (ii) For a lithium ion battery, the Watt-hour rating must not
exceed 100 Wh.
    (15) A wheelchair or other battery-powered mobility aid equipped
with a non-spillable battery or a dry sealed battery when carried as
checked baggage, provided--
    (i) The battery conforms to the requirements of Sec.  173.159a(d)
of this subchapter for non-spillable batteries;
    (ii) The battery conforms to the requirements of Sec.
172.102(c)(1), Special provision 130 of this subchapter for dry sealed
batteries, as applicable;
    (iii) Visual inspection including removal of the battery, where
necessary, reveals no obvious defects (removal of the battery from the
housing should be performed by qualified airline personnel only);
    (iv) The battery is disconnected and the battery terminals are
protected to prevent short circuits, unless the wheelchair or mobility
aid design provides an effective means of preventing unintentional
activation;
    (v) The non-spillable battery is--
    (A) Securely attached to the wheelchair or mobility aid;
    (B) Removed and placed in a strong, rigid packaging marked
``NONSPILLABLE BATTERY'' (unless fully enclosed in a rigid housing that
is properly marked); or
    or
    (C) Is handled in accordance with paragraph (a)(16)(iv) of this
section; and
    (vi) The dry sealed battery is--
    (A) Securely attached to the wheelchair or mobility aid; or
    (B) Removed and placed in a strong, rigid packaging marked with the
words ``not restricted'' in accordance with Sec.  172.102(c)(2),
special provision 130, of this subchapter;
    (vii) A maximum of one spare battery that conforms to the
requirements in (a)(15)(i) or (ii) may be carried per passenger if
handled in accordance with paragraph (a)(15)(v) or (vi) of this
section, as applicable.
* * * * *
    (17) * * *
    (v) Where a lithium ion battery-powered wheelchair or other
mobility aid does not provide adequate protection to the battery:
* * * * *
    (18) Except as provided in Sec.  173.21 of this subchapter,
portable electronic devices (e.g., watches, calculating machines,
cameras, cellular phones, laptop and notebook computers, camcorders,
medical devices, etc.) containing dry cells or dry batteries (including
lithium cells or batteries) and spare dry cells or batteries for these
devices, when carried by passengers or crew members for personal use.
Portable electronic devices powered by lithium batteries may be carried
in either checked or carry-on baggage. When carried in checked baggage,
portable electronic devices powered by lithium batteries must be
completely switched off (not in sleep or hibernation mode) and
protected to prevent unintentional activation or damage. Spare lithium
batteries must be carried in carry-on baggage only. Each installed or
spare lithium battery must be of a type proven to meet the requirements
of each test in the UN Manual of Tests and Criteria, Part III, Sub-
section 38.3, and each spare lithium battery must be individually
protected so as to prevent short circuits (e.g., by placement in
original retail packaging, by otherwise insulating terminals by taping
over exposed terminals, or placing each battery in a separate plastic
bag or protective pouch). In addition, each installed or spare lithium
battery:
    (i) For a lithium metal battery, the lithium content must not
exceed 2 grams;
    (ii) For a lithium ion battery, the Watt-hour rating must not
exceed 100 Wh. With the approval of the operator, portable electronic
devices may contain lithium ion batteries exceeding 100 Wh, but not
exceeding 160 Wh and no more than two individually protected lithium
ion batteries each exceeding 100 Wh, but not exceeding 160 Wh, may be

carried per person as spare batteries in carry-on baggage.
    (iii) For a non-spillable battery, the battery and equipment must
conform to Sec.  173.159a(d). Each battery must not exceed a voltage
greater than 12 volts and a watt-hour rating of not more than 100 Wh.
No more than two individually protected spare batteries may be carried.
Such equipment and spare batteries must be carried in checked or carry-
on baggage.
    (iv) Articles containing lithium metal or lithium ion cells or
batteries the primary purpose of which is to provide power to another
device must be carried as spare batteries in accordance with the
provisions of this paragraph.
    (19) Except as provided in Sec.  173.21 of this subchapter,
battery-powered portable electronic smoking devices (e.g., e-
cigarettes, e-cigs, e-cigars, e-pipes, e-hookahs, personal vaporizers,
electronic nicotine delivery systems) when carried by passengers or
crewmembers for personal use must be carried on one's person or in
carry-on baggage only. Measures must be taken to prevent unintentional
activation of the heating element while on board the aircraft. Spare
lithium batteries also must be carried on one's person or in carry-on
baggage only and must be individually protected so as to prevent short
circuits (by placement in original retail packaging or by otherwise
insulating terminals, e.g., by taping over exposed terminals or placing
each battery in a separate plastic bag or protective pouch). Each
lithium battery must be of a type which meets the requirements of each
test in the UN Manual of Tests and Criteria, Part III, Subsection 38.3.
Recharging of the devices and/or the batteries on board the aircraft is
not permitted. Each installed or spare lithium battery:
    (i) For a lithium metal battery, the lithium content must not
exceed 2 grams; or
    (ii) For a lithium ion battery, the Watt-hour rating must not
exceed 100 Wh.
* * * * *
    (26) Baggage equipped with lithium battery(ies) must be carried as
carry-on baggage unless the battery(ies) is removed from the baggage.
Removed battery(ies) must be carried in accordance with the provision
for spare batteries prescribed in paragraph (a)(18) of this section.
The provisions of this paragraph do not apply to baggage equipped with
lithium batteries not exceeding:
    (i) For lithium metal batteries, a lithium content of 0.3 grams; or
    (ii) For lithium ion batteries, a Watt-hour rating of 2.7 Wh
* * * * *
0
37. In Sec.  175.33, paragraphs (a)(12) and (a)(13)(i) are revised to
read as follows:

Sec.  175.33   Shipping paper and notification of pilot-in-command.

    (a) * * *
    (12) For UN1845, Carbon dioxide, solid (dry ice), the information
required by paragraph (a) of this section may be replaced by the UN
number, proper shipping name, hazard class, total quantity in each
cargo compartment aboard the aircraft, and the airport at which the
package(s) is to be unloaded must be provided.
    (13)(i) For UN3480, Lithium ion batteries, and UN3090, Lithium
metal batteries, the information required by paragraph (a) of this
section may be replaced by the UN number, proper shipping name, class,
total quantity at each specific loading location, the airport at which
the package(s) is to be unloaded, and whether the package must be
carried on cargo aircraft only. UN3480 (Lithium ion batteries) and
UN3090 (Lithium metal batteries) carried under a special permit or a
State exemption as prescribed in the ICAO Technical Instructions must
meet all of the requirements of this section.
* * * * *
0
38. In Sec.  175.78, paragraph (b) is revised and paragraph (c)(8) is
added to read as follows:

Sec.  175.78   Stowage compatibility of cargo.

* * * * *
    (b)(1) At a minimum, the segregation instructions prescribed in the
following Segregation Table must be followed to maintain acceptable
segregation between packages containing hazardous materials with
different hazards. The Segregation Table instructions apply whether or
not the class or division is the primary or subsidiary risk.
    (2) Packages and overpacks containing articles of Identification
Numbers UN3090 and UN3480 prepared in accordance with Sec.
173.185(b)(3) and (c)(4)(vi) must not be stowed on an aircraft next to,
in contact with, or in a position that would allow interaction with
packages or overpacks containing hazardous materials that bear a Class
1 (other than Division 1.4S), Division 2.1, Class 3, Division 4.1, or
Division 5.1 hazard label. To maintain acceptable segregation between
packages and overpacks, the segregation requirements shown in the
Segregation Table must be followed. The segregation requirements apply
based on all hazard labels applied to the package or overpack,
irrespective of whether the hazard is the primary or subsidiary hazard.

                                                        Table to Paragraph (b): Segregation Table
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                Class or division
                                   ---------------------------------------------------------------------------------------------------------------------
           Hazard label                                                                                9 see
                                        1        2.1    2.2, 2.3        3          4.1       4.2       4.3         5.1         5.2        8      (b)(2)
--------------------------------------------------------------------------------------------------------------------------------------------------------
1.................................   Note 1    Note 2    Note 2        Note 2    Note 2    Note 2    Note 2        Note 2    Note 2    Note 2    Note 2
2.1...............................   Note 2   ........  ........  ............  ........  ........  ........  ............  ........  ........        X
2.2, 2.3..........................   Note 2   ........  ........  ............  ........  ........  ........  ............  ........  ........  ........
3.................................   Note 2   ........  ........  ............  ........  ........  ........   X (Note 3)   ........  ........        X
4.1...............................   Note 2   ........  ........  ............  ........  ........  ........  ............  ........  ........        X
4.2...............................   Note 2   ........  ........  ............  ........  ........  ........            X   ........  ........  ........
4.3...............................   Note 2   ........  ........  ............  ........  ........  ........  ............  ........        X   ........
5.1...............................   Note 2   ........  ........   X (Note 3)   ........        X   ........  ............  ........  ........        X
5.2...............................   Note 2   ........  ........  ............  ........  ........  ........  ............  ........  ........  ........
8.................................   Note 2   ........  ........  ............  ........  ........        X   ............  ........  ........  ........
9 see (b)(2)......................   Note 2         X   ........            X         X   ........  ........            X   ........  ........  ........
--------------------------------------------------------------------------------------------------------------------------------------------------------

* * * * *
    (c) * * *
    (8) Note 3. ``Note 3'' at the intersection of a row and column
means that UN3528, Engines, internal combustion, flammable liquid
powered;

Engines, fuel cell, flammable liquid powered; Machinery internal
combustion, flammable liquid powered; and Machinery, fuel cell,
flammable liquid powered need not be segregated from packages
containing dangerous goods in Division 5.1.

PART 176--CARRIAGE BY VESSEL

0
39. The authority citation for part 176 continues to read as follows:

    Authority:  49 U.S.C. 5101-5128; 49 CFR 1.81 and 1.97.

0
40. In Sec.  176.30, paragraph (a)(9) is added to read as follows:

Sec.  176.30   Dangerous cargo manifest.

* * * * *
    (a) * * *
    (9) For excepted packages containing Class 7 materials only the
following information is required:
    (i) The UN identification number for the material preceded by the
letters ``UN'';
    (ii) The name and address of the consignor and the consignee; and
    (iii) The stowage location of the hazardous material on board the
vessel.
* * * * *
0
41. In Sec.  176.84, paragraph (b) table provisions 151, 152, 153, and
154 are added to read as follows:

Sec.  176.84   Other requirements for stowage, cargo handling, and
segregation for cargo vessels and passenger vessels.

* * * * *
    (b) * * *

------------------------------------------------------------------------
               Code                              Provisions
------------------------------------------------------------------------

                              * * * * * * *
151...............................  Segregation as for Class 7.
152...............................  Segregation as for Class 8. However,
                                     in relation to Class 7, no
                                     segregation needs to be applied.
153...............................  Stow ``separated longitudinally by
                                     an intervening complete compartment
                                     or hold from'' Divisions 1.1, 1.2,
                                     and 1.5.
154...............................  Notwithstanding the stowage category
                                     indicated in column 10A of the Sec.
                                       172.101 Table, may be stowed in
                                     accordance with the provisions of
                                     packing instruction US 1 in Sec.
                                     173.62.

                              * * * * * * *
------------------------------------------------------------------------

* * * * *

PART 178--SPECIFICATIONS FOR PACKAGINGS

0
42. The authority citation for part 178 continues to read as follows:

    Authority:  49 U.S.C. 5101-5128; 49 CFR 1.81 and 1.97.
0
43. In Sec.  178.71, revise paragraphs (d)(2) and (f) introductory
text, add paragraph (f)(4), and revise paragraphs (i), (j), and (q)(12)
are revised to read as follows:

Sec.  178.71  Specifications for UN pressure receptacles.

* * * * *
    (d) * * *
    (2) Service equipment must be configured or designed to prevent
damage that could result in the release of the pressure receptacle
contents during normal conditions of handling and transport. Manifold
piping leading to shut-off valves must be sufficiently flexible to
protect the valves and the piping from shearing or releasing the
pressure receptacle contents. The filling and discharge valves and any
protective caps must be secured against unintended opening. The valves
must conform to ISO 10297:2014(E) or, for non-refillable pressure
receptacles valves manufactured until December 31, 2020, ISO
13340:2001(E) (IBR, see Sec.  171.7 of this subchapter), and be
protected as specified in Sec.  173.301b(f) of this subchapter. Until
December 31, 2020, the manufacture of a valve conforming to the
requirements in ISO 10297:2006(E) (IBR, see Sec.  171.7 of this
subchapter) is authorized. Until December 31, 2008, the manufacture of
a valve conforming to the requirements in ISO 10297:1999(E) (IBR, see
Sec.  171.7 of this subchapter) is authorized. Additionally, valves
must be initially inspected and tested in accordance with ISO
14246:2014(E) Gas cylinders--Cylinder valves--Manufacturing tests and
examinations (IBR, see Sec.  171.7 of this subchapter).
* * * * *
    (f) Design and construction requirements for UN refillable welded
cylinders and UN pressure drums. In addition to the general
requirements of this section, UN refillable welded cylinders and UN
pressure drums must conform to the following ISO standards, as
applicable:
* * * * *
    (4) ISO 21172-1:2015(E) Gas cylinders--Welded steel pressure drums
up to 3,000 litres capacity for the transport of gases--Design and
construction--Part 1: Capacities up to 1,000 litres (IBR, see Sec.
171.7 of this subchapter). Irrespective of section <IP_ADDRESS> of this
standard, welded steel gas pressure drums with dished ends convex to
pressure may be used for the transport of corrosive substances provided
all applicable additional requirements are met.
* * * * *
    (i) Design and construction requirements for UN non-refillable
metal cylinders. In addition to the general requirements of this
section, UN non-refillable metal cylinders must conform to ISO
11118:2015(E) Gas cylinders--Non-refillable metallic gas cylinders--
Specification and test methods (IBR, see Sec.  171.7 of this
subchapter). Until December 31, 2020, cylinders conforming to ISO
11118:1999(E) Gas cylinders--Non-refillable metallic gas cylinders--
Specification and test methods (IBR, see Sec.  171.7 of this
subchapter) are authorized.
    (j) Design and construction requirements for UN refillable seamless
steel tubes. In addition to the general requirements of this section,
UN refillable seamless steel tubes must conform to ISO 11120:2015(E)
Gas cylinders--Refillable seamless steel tubes of water capacity
between 150 L and 3,000 L--Design, construction and testing (IBR, see
Sec.  171.7 of this subchapter). Until December 31, 2022, UN refillable
seamless steel tubes may be manufactured in accordance with ISO 11120:
Gas cylinders--Refillable seamless steel tubes of water capacity
between 150 L and 3,000 L--Design, construction and testing (IBR, see
Sec.  171.7 of this subchapter).
* * * * *
    (q) * * *
    (12) Identification of the cylinder thread type (e.g., 25E).
Information on the marks that may be used for identifying threads for
cylinders is given in ISO/TR 11364, Gas Cylinders--Compilation of
national and international valve stem/gas cylinder neck threads and
their identification and marking system (IBR, see Sec.  171.7 of this
subchapter).
* * * * *

0
44. In Sec.  178.75 paragraph (d)(3)(v) is revised to read as follows:

Sec.  178.75  Specifications for UN pressure receptacles.

* * * * *
    (d) * * *
    (3) * * *
    (v) ISO 11120:2015(E) Gas cylinders--Refillable seamless steel
tubes of water capacity between 150 L and 3000 L--Design, construction
and testing (IBR, see Sec.  171.7 of this subchapter). Until December
31, 2020, pressure receptacles of a MEGC may be constructed and tested
in accordance with ISO 11120:1999(E) Gas cylinders--Refillable seamless
steel tubes of water capacity between 150 L and 3000 L--Design,
construction and testing (IBR, see Sec.  171.7 of this subchapter).
* * * * *
0
45. In Sec.  178.601, paragraph (l)(2)(viii) is revised to read as
follows:

Sec.  178.601  General requirements.

* * * * *
    (1) * * *
    (2) * * *
    (viii) Characteristics of test contents, including for plastic
packagings subject to the hydrostatic pressure test in Sec.  178.605 of
this subpart, the temperature of the water used;
* * * * *
0
46. In Sec.  178.801, paragraph (l)(2)(viii) is revised to read as
follows:

Sec.  178.801  General Requirements.

* * * * *
    (1) * * *
    (2) * * *
    (viii) Characteristics of test contents, including for rigid
plastics and composite IBCs subject to the hydrostatic pressure test in
Sec.  178.814 of this subpart, the temperature of the water used;
* * * * *
0
47. In Sec.  178.810, paragraph (c)(1) is revised to read as follows:

Sec.  178.810  Drop test.

* * * * *
    (c) * * *
    (1) Samples of all IBC design types must be dropped onto a rigid,
non-resilient, smooth, flat, and horizontal surface. The point of
impact must be the most vulnerable part of the base of the IBC being
tested. Following the drop, the IBC must be restored to the upright
position for observation. The same IBC or a different IBC of the same
design may be used for each drop.
* * * * *

PART 180--CONTINUING QUALIFICATION AND MAINTENANCE OF PACKAGINGS

0
48. The authority citation for part 180 continues to read as follows:

    Authority:  49 U.S.C. 5101-5128; 49 CFR 1.81 and 1.97.

0
49. In Sec.  180.207, paragraphs (a)(2) and (d)(1) and (4) are revised
and paragraph (d)(6) is added to read as follows:

Sec.  180.207  Requirements for requalification of UN pressure
receptacles.

* * * * *
    (a) * * *
    (2) No pressure receptacle due for requalification may be filled
with a hazardous material and offered for transportation in commerce
unless that pressure receptacle has been successfully requalified and
marked in accordance with this subpart. A pressure receptacle may be
requalified at any time during or before the month and year that the
requalification is due. However, a pressure receptacle filled before
the requalification becomes due may remain in service until it is
emptied. In accordance with the Transport Canada TDG Regulations (IBR,
see Sec.  171.7) a CAN marked UN cylinder may be requalified in the
United States by a domestic requalifier, provided the requirements in
Sec. Sec.  178.69, 178.70, and 178.71, as applicable, are met.
* * * * *
    (d) * * *
    (1) Seamless steel: Each seamless steel UN pressure receptacle,
including MEGC's pressure receptacles, must be requalified in
accordance with ISO 6406:2005(E) (IBR, see Sec.  171.7 of this
subchapter). However, UN cylinders with a tensile strength greater than
or equal to 950 MPa must be requalified by ultrasonic examination in
accordance with ISO 6406:2005(E). For seamless steel cylinders and
tubes, the internal inspection and hydraulic pressure test may be
replaced by a procedure conforming to ISO 16148:2016(E) (IBR, see Sec.
171.1).
* * * * *
    (4) Composite UN cylinders: Each composite cylinder must be
inspected and tested in accordance with ISO 11623:2015(E) (IBR, see
Sec.  171.7 of this subchapter). Until December 31, 2020, ISO
11623:2002(E) (IBR, see Sec.  171.7 of this subchapter) may be used.
* * * * *
    (6) Valves: Inspection and maintenance of cylinder valves must be
carried out in accordance with ISO 22434:2006 Transportable gas
cylinders--Inspection and maintenance of cylinder valves (IBR, see
Sec.  171.7 of this subchapter).

     Issued in Washington, DC, on November 6, 2018, under authority
delegated in 49 CFR 1.97.
William S. Schoonover,
Associate Administrator for Hazardous Materials Safety, Pipeline and
Hazardous Materials Safety Administration.
[FR Doc. 2018-24620 Filed 11-26-18; 8:45 am]
 BILLING CODE 4910-60-P


[Federal Register: January 24, 2008 (Volume 73, Number 16)]
[Rules and Regulations]
[Page 4059-4061]
[DOCID:fr24ja08-6]

-----------------------------------------------------------------------

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2007-29329; Directorate Identifier 2007-NM-205-AD;
Amendment 39-15342; AD 2008-02-12]
RIN 2120-AA64

Airworthiness Directives; McDonnell Douglas Model 717-200
Airplanes

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Final rule.

-----------------------------------------------------------------------

SUMMARY: We are adopting a new airworthiness directive (AD) for certain
McDonnell Douglas Model 717-200 airplanes. This AD requires
modification of the conduit for the forward boost pump of the center
fuel tank. This AD results from the finding that a potential chafing
condition exists in the volute assembly of the forward boost pump for
the center fuel tank. We are issuing this AD to prevent chafing of the
fuel boost pump wiring that could lead to arcing to the inside of the
45-degree angle fitting, which, in combination with flammable fuel
vapors, could result in a fuel tank explosion and consequent loss of
the airplane.

DATES: This AD is effective February 28, 2008.
    The Director of the Federal Register approved the incorporation by
reference of a certain publication listed in this AD as of February 28,
2008.

ADDRESSES: For service information identified in this AD, contact
Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood
Boulevard, Long Beach, California 90846, Attention: Data and Service
Management, Dept. C1-L5A (D800-0024).

Examining the AD Docket

    You may examine the AD docket on the Internet at http://www.regulations.gov
; or in person at the Docket Management Facility

between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this AD, the regulatory evaluation,
any comments received, and other information. The address for the
Docket Office (telephone<PHONE_NUMBER>) is the Document Management
Facility, U.S. Department of Transportation, Docket Operations, M-30,
West Building Ground Floor, Room W12-140, 1200 New Jersey Avenue, SE.,
Washington, DC 20590.

FOR FURTHER INFORMATION CONTACT: Samuel S. Lee, Aerospace Engineer,
Propulsion Branch, ANM-140L, FAA,

Los Angeles Aircraft Certification Office, 3960 Paramount Boulevard,
Lakewood, California 90712-4137; telephone<PHONE_NUMBER>; fax (562)
627-5210.

SUPPLEMENTARY INFORMATION:

Discussion

    We issued a notice of proposed rulemaking (NPRM) to amend 14 CFR
part 39 to include an airworthiness directive (AD) that would apply to
certain McDonnell Douglas Model 717-200 airplanes. That NPRM was
published in the Federal Register on October 11, 2007 (72 FR 57892).
That NPRM proposed to require modification of the conduit for the
forward boost pump of the center fuel tank.

Comments

    We gave the public the opportunity to participate in developing
this AD. We have considered the two comments received from the one
commenter.

Support for the NPRM

    AirTran Airways supports the NPRM.

Request To Allow Use of Original Issue of Service Bulletin

    AirTran Airways requests that we revise this AD to specify that
actions accomplished before the effective date of this AD in accordance
with Boeing Service Bulletin 717-28-0007, dated August 22, 2002, are
considered acceptable for compliance with the corresponding actions
specified in paragraph (f) of this AD provided that a leak check of the
conduit is accomplished in accordance with Boeing 717 Airplane
Maintenance Manual (AMM) Task 28-22-28-700-801, ``Leak Test of the Fuel
Pump Electrical Conduit.'' AirTran Airways has accomplished the actions
specified in the original issue of the service bulletin on all
applicable airplanes in its fleet. AirTran Airways states that Revision
1, dated September 23, 2003, of the service bulletin was published to
provide a torque value for the conduits due to an instance of fuel
leaking from the conduit at the front spar following accomplishment of
the task. AirTran Airways notes that it accomplished a leak check of
the conduit during accomplishment of the original issue of the service
bulletin, and that the leak check was later added to the AMM in January
2004, as AMM Task 28-22-28-700-801. The leak check of the conduit
ensured that the conduit was not leaking, in the absence of a specified
torque value in the original issue of the service bulletin. AirTran
Airways believes that, if operators have accomplished the modification
in accordance with the original issue of the service bulletin,
accomplishing a leak check of the conduits using AMM Task 28-22-28-700-
801 should be acceptable to ensure that the conduits are not leaking in
lieu of accessing the conduit connections again for a torque check.
    We agree that work done in accordance with Boeing Service Bulletin
717-28-0007, dated August 22, 2002, is acceptable for compliance with
the requirements of this AD provided that a leak check of the conduit
is accomplished in accordance with Boeing 717 AMM Task 28-22-28-700-
801. We have added a new paragraph (g) to this AD to allow credit for
previous accomplishment.

Conclusion

    We reviewed the relevant data, considered the comments received,
and determined that air safety and the public interest require adopting
the AD with the change described previously. We also determined that
this change will not increase the economic burden on any operator or
increase the scope of the AD.

Costs of Compliance

    There are about 77 airplanes of the affected design in the
worldwide fleet. This AD affects about 61 airplanes of U.S. registry.
The required actions take about 10 work hours per airplane, at an
average labor rate of $80 per work hour. Based on these figures, the
estimated cost of the AD for U.S. operators is $48,800, or $800 per
airplane.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    This AD will not have federalism implications under Executive Order
13132. This AD will not have a substantial direct effect on the States,
on the relationship between the national government and the States, or
on the distribution of power and responsibilities among the various
levels of government.
    For the reasons discussed above, I certify that this AD:
    (1) Is not a ``significant regulatory action'' under Executive
Order 12866,
    (2) Is not a ``significant rule'' under DOT Regulatory Policies and
Procedures (44 FR 11034, February 26, 1979), and
    (3) Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    You can find our regulatory evaluation and the estimated costs of
compliance in the AD Docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

Adoption of the Amendment

0
Accordingly, under the authority delegated to me by the Administrator,
the FAA amends 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

0
1. The authority citation for part 39 continues to read as follows:

    Authority: 49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

0
2. The FAA amends Sec.  39.13 by adding the following new AD:

2008-02-12 McDonnell Douglas: Amendment 39-15342. Docket No. FAA-
2007-29329; Directorate Identifier 2007-NM-205-AD.

Effective Date

    (a) This airworthiness directive (AD) is effective February 28,
2008.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to McDonnell Douglas Model 717-200
airplanes, certificated in any category; as identified in Boeing
Service Bulletin 717-28-0007, Revision 1, dated September 23, 2003.

Unsafe Condition

    (d) This AD results from a finding that a potential chafing
condition exists in the volute assembly of the forward boost pump
for the center fuel tank. We are issuing this

AD to prevent chafing of the forward boost pump wiring that could
lead to arcing to the inside of the 45-degree angle fitting, which,
in combination with flammable fuel vapors, could result in a fuel
tank explosion and consequent loss of the airplane.

Compliance

    (e) You are responsible for having the actions required by this
AD performed within the compliance times specified, unless the
actions have already been done.

Modification

    (f) Within 78 months after the effective date of this AD, modify
the conduit for the forward fuel boost pump of the center fuel tank,
by accomplishing all of the actions specified in Boeing Service
Bulletin 717-28-0007, Revision 1, dated September 23, 2003.

Credit for Actions Done According to Previous Issue of Service Bulletin

    (g) Actions done before the effective date of this AD in
accordance with Boeing Service Bulletin 717-28-0007, dated August
22, 2002, are acceptable for compliance with the requirements of
paragraph (f) of this AD provided that a leak check of the conduit
is accomplished in accordance with Boeing 717 Airplane Maintenance
Manual (AMM) Task 28-22-28-700-801, ``Leak Test of the Fuel Pump
Electrical Conduit.''

Alternative Methods of Compliance (AMOCs)

    (h)(1) The Manager, Los Angeles Aircraft Certification Office
(ACO), FAA, has the authority to approve AMOCs for this AD, if
requested in accordance with the procedures found in 14 CFR 39.19.
    (2) To request a different method of compliance or a different
compliance time for this AD, follow the procedures in 14 CFR 39.19.
Before using any approved AMOC on any airplane to which the AMOC
applies, notify your appropriate principal inspector (PI) in the FAA
Flight Standards District Office (FSDO), or lacking a PI, your local
FSDO.

Material Incorporated by Reference

    (i) You must use Boeing Service Bulletin 717-28-0007, Revision
1, dated September 23, 2003, to do the actions required by this AD,
unless the AD specifies otherwise.
    (1) The Director of the Federal Register approved the
incorporation by reference of this service information under 5
U.S.C. 552(a) and 1 CFR part 51.
    (2) For service information identified in this AD, contact
Boeing Commercial Airplanes, Long Beach Division, 3855 Lakewood
Boulevard, Long Beach, California 90846, Attention: Data and Service
Management, Dept. C1-L5A (D800-0024).
    (3) You may review copies of the service information
incorporated by reference at the FAA, Transport Airplane
Directorate, 1601 Lind Avenue, SW., Renton, Washington; or at the
National Archives and Records Administration (NARA). For information
on the availability of this material at NARA, call<PHONE_NUMBER>, or
go to: http://www.archives.gov/federal_register/code_of_federal_regulations/ibr_locations.html
.

    Issued in Renton, Washington, on January 14, 2008.
Stephen P. Boyd,
Assistant Manager, Transport Airplane Directorate, Aircraft
Certification Service.
 [FR Doc. E8-971 Filed 1-23-08; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 83, Number 231 (Friday, November 30, 2018)]
[Notices]
[Pages 61646-61648]
[FR Doc No: 2018-26032]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0597]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Oversight of Clinical Investigations: A Risk-Based
Approach to Monitoring

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
an opportunity for public

comment on the proposed collection of certain information by the
Agency. Under the Paperwork Reduction Act of 1995 (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 information collection associated with oversight
of clinical investigations, a risk-based approach to monitoring.

DATES: Submit either electronic or written comments on the collection
of information by January 29, 2019.

ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 29, 2019. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 29, 2019. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.

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 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, 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-2011-D-0597 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Oversight of Clinical
Investigations: A Risk-Based Approach to Monitoring.'' Received
comments, those filed in a timely manner (see ADDRESSES), will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff 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 Dockets Management Staff. 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.gpo.gov/fdsys/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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.

Oversight of Clinical Investigations: A Risk-Based Approach to
Monitoring--21 CFR Parts 312 and 812

OMB Control Number 0910-0733--Extension

    This information collection supports reporting and recordkeeping
found in Agency guidance. Under parts 312 and 812 (21 CFR parts 312 and
812), sponsors are required to provide

appropriate oversight of their clinical investigations to ensure
adequate protection of the rights, welfare, and safety of human
subjects and to ensure the quality and integrity of the resulting data
submitted to FDA. As part of this oversight, sponsors of clinical
investigations are required to monitor the conduct and progress of
their clinical investigations. The regulations do not specify how
sponsors are to conduct monitoring of clinical investigations and are,
therefore, compatible with a range of approaches to monitoring.
    Accordingly, we developed the guidance document entitled,
``Guidance for Industry--Oversight of Clinical Investigations: A Risk-
Based Approach to Monitoring.'' The guidance is intended to assist
sponsors of clinical investigations in developing strategies for risk-
based monitoring and plans for clinical investigations of human drug
and biological products, medical devices, and combinations thereof. The
guidance describes strategies for monitoring activities performed by
sponsors or by contract research organizations (CROs) that focus on the
conduct, oversight, and reporting of findings of an investigation by
clinical investigators. The guidance also recommends strategies that
reflect a risk-based approach to monitoring that focuses on critical
study parameters and relies on a combination of monitoring activities
to oversee a study effectively. Finally, the guidance specifically
encourages greater reliance on centralized monitoring methods where
appropriate.
    Information collections for reports and records associated with
clinical investigations under parts 312 and 812 are currently approved
under OMB control numbers 0910-0014 and 0910-0078 respectively. These
reporting and recordkeeping provisions cover general elements. The
guidance discusses other elements sponsors and investigators should
consider and include in developing a monitoring plan. As explained in
the guidance, documentation of monitoring should include sufficient
detail to allow verification that the monitoring plan was followed. The
plan should provide adequate information to those involved with
monitoring to effectively carry out their duties. All sponsor and CRO
personnel who may be involved with monitoring (including those who
review appropriate action, determine appropriate action, or both)
regarding potential issues identified through monitoring should review
the monitoring plan.
    We estimate the burden of this collection of information as
follows:

                               Table 1--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
            Activity                 Number of      records per    Total Annual     burden per      Total hours
                                   recordkeepers   recordkeeper       Records      recordkeeping
----------------------------------------------------------------------------------------------------------------
Documentation included in                     88             1.5             132               4             528
 comprehensive monitoring plan..
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Based on a review of the information collection, we have made no
adjustments to our burden estimate. We estimate 88 sponsors will
develop 132 comprehensive monitoring plans in accordance with the
guidance. We believe the associated burden for each plan is
approximately 4 hours and includes the time necessary to develop, and
amend as appropriate, the monitoring plan.

    Dated: November 26, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26032 Filed 11-29-18; 8:45 am]
 BILLING CODE 4164-01-P