exceed one liter (61.0 cubic inches). The maximum inside diameter shall
not exceed 3 inches.

Sec.  178.33b-3  Inspection.

    (a) By competent inspector.
    (b) [Reserved]

Sec.  178.33b-4  Duties of inspector.

    (a) To inspect material and completed containers and witness tests,
and to reject defective materials or containers.
    (b) [Reserved]

Sec.  178.33b-5  Material.

    (a) The receptacles must be constructed of polyethylene
terephthalate (PET), polyethylene napthalate (PEN), polyamide (Nylon)
or a blend of PET, PEN, ethyl vinyl alcohol (EVOH) and/or Nylon.
    (b) Material with seams, cracks, laminations or other injurious
defects are forbidden.

Sec.  178.33b-6  Manufacture.

    (a) Each container must be manufactured by thermoplastic processes
that will assure uniformity of the completed container. No used
material other than production residues or regrind from the same
manufacturing process may be used. The packaging must be adequately
resistant to aging and to degradation caused either by the substance
contained or by ultraviolet radiation.
    (b) [Reserved]

Sec.  178.33b-7  Design qualification test.

    (a) Drop testing.
    (1) To ensure that creep does not affect the ability of the
container type to retain the contents, each container type shall be
drop tested as follows: three groups of twenty-five filled containers
shall be dropped from 1.8m on to a rigid, non-resilient, flat and
horizontal surface. One group must be conditioned at 38 [deg]C (100
[deg]F) for 26 weeks, the second group for 100 hours at 50 [deg]C (122
[deg]F) and the third group for 18 hours at 55 [deg]C (131 [deg]F),
prior to performing the drop test.
    (2) Criteria for passing the drop test: the containers must not
break or leak.
    (b) [Reserved]

Sec.  178.33b-8  Production Tests.

    (a) Burst testing.
    (1) One out of each lot of 5,000 containers or less, successively
produced per day must be pressure tested to destruction and must not
burst below 240 psig. The container tested must be complete as intended
for transportation.
    (2) Each such 5,000 containers or less, successively produced per
day, shall constitute a lot and if the test container shall fail, the
lot shall be rejected or ten additional containers may be selected at
random and subjected to the test under which failure occurred. These
containers shall be complete as intended for transportation. Should any
of the ten containers thus tested fail, the entire lot must be
rejected. All containers constituting a lot shall be of like material,
size, design construction, finish, and quality.
    (b) Leak testing.
    (1) Each empty container must be subjected to a pressure equal to
or in excess of the maximum expected in the filled containers at 55
[deg]C (131 [deg]F) 50 [deg]C (122 [deg]F) if the liquid phase does not
exceed 95 percent of the capacity of the container at 50 [deg]C (122
[deg]F). This must be at least two-thirds of the design pressure of the
aerosol dispenser. If any container shows evidence of leakage at a rate
equal to or greater than 3.3 x 10-2mbar.l.s-1 at
20 [deg]C (68 [deg]F), at the test pressure, distortion or other
defect, it must be rejected.
    (2) Prior to filling, the filler must ensure that the crimping
equipment is set appropriately and the specified propellant is used.
Once filled, each container must be weighed and leak tested. The leak
detection equipment must be sufficiently sensitive to detect at least a
leak rate of 2.0 x 10-3 mbar.l.s-1 at 20 [deg]C
(68[deg]F). Any filled container which shows evidence of leakage,
deformation, or excessive weight must be rejected.

Sec.  178.33b-9  Marking.

    (a) Each container must be clearly and permanently marked to show:
    (1) DOT-2S.
    (2) Name or symbol of person making the mark specified in paragraph
(a)(1) of this section. Symbol, if used, must be registered with the
Associate Administrator.
    (b) [Reserved]
    59. In Sec.  178.502, paragraph (d) is revised and a note to the
section is added to read as follows:

Sec.  178.502  Identification codes for packagings.

* * * * *
    (d) Identification codes are set forth in the standards for
packagings in Sec. Sec.  178.504 through 178.523 of this subpart.

    Note to Sec.  178.502: Plastics materials include other
polymeric materials such as rubber.

    60. In Sec.  178.703, paragraph (a)(1)(vii) is revised to read as
follows:

Sec.  178.703  Marking of IBCs.

* * * * *
    (a) * * *
    (1) * * *
    (vii) (A) The stacking test load in kilograms (kg). For IBCs not
designed for stacking, the figure ``0'' must be shown. For IBCs
designed for stacking, the maximum permitted stacking load applicable
when the IBC is in use shall be displayed on a symbol for all IBCs
manufactured, repaired or remanufactured after January 1, 2011 as
follows:
[GRAPHIC] [TIFF OMITTED] TP31JY08.017

    (B) The symbol shall be not less than 100 mm (3.9 inches) x 100 mm
(3.9 inches), be durable and clearly visible. The letters and numbers
shall be at least 12 mm high (.48 inches). The mass marked above the
symbol shall not exceed the load imposed during the design test divided
by 1.8.
* * * * *
    61. In Sec.  178.801, paragraph (f)(1)(i) is revised to read as
follows:

Sec.  178.801  General requirements.

* * * * *
    (f) * * *
    (1) * * *
    (i) The IBC need not have its closures fitted, except that the IBC
must be fitted with its primary bottom closure.
* * * * *
    62. In Sec.  178.810, paragraph (e) is revised to read as follows:

Sec.  178.810  Drop test.

* * * * *
    (e) Criteria for passing the test. For all IBC design types, there
may be no damage which renders the IBC unsafe to be transported for
salvage or for disposable, and no loss of contents. The IBC shall be
capable of being lifted by an appropriate means until clear of the
floor for five minutes. A slight discharge from a closure upon impact
is not considered to be a failure of the IBC provided that no further
leakage occurs. A slight discharge (e.g., from closures or stitch
holes) upon impact is not considered a failure of the flexible IBC
provided that no further leakage occurs after the IBC has been raised
clear of the ground.

    Issued in Washington, DC, on July 15, 2008 under authority
delegated in 49 CFR part 106.
Theodore L. Willke,
Associate Administrator for Hazardous Materials Safety.
[FR Doc. E8-16579 Filed 7-30-08; 8:45 am]

BILLING CODE 4910-60-P


[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30621-30622]
[FR Doc No: 2014-12294]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2012-E-1244 and FDA-2012-E-1245]

Determination of Regulatory Review Period for Purposes of Patent
Extension; MENHIBRIX

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for MENHIBRIX and is publishing this notice of
that determination as required by law. FDA has made the determination
because of the submission of applications to the Director of Patents
and Trademarks, Department of Commerce, for the extension of a patent
which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver
Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 100-670) generally provide
that a patent may be extended for a period of up to 5 years so long as
the patented item (human drug product, animal drug product, medical
device, food additive, or color additive) was subject to regulatory
review by FDA before the item was marketed. Under these acts, a
product's regulatory review period forms the basis for determining the
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A
testing phase and an approval phase. For human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human biological product and
continues until FDA grants permission to market the biological product.
Although only a portion of a regulatory review period may count toward
the actual amount of extension that the Director of Patents and
Trademarks may award (for example, half the testing phase must be
subtracted as well as any time that may have occurred before the patent
was issued), FDA's determination of the length of a regulatory review
period for a human biological product will include all of the testing
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA has approved for marketing the human biologic product MENHIBRIX
(Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid

Conjugate Vaccine). MENHIBRIX is a vaccine indicated for active
immunization to prevent invasive disease caused by Neisseria
meningitides serogroups C and Y and Haemophilus influenzae type b.
Subsequent to this approval, the Patent and Trademark Office received
patent term restoration applications for MENHIBRIX (U.S. Patent Nos.
5,693,326 and 5,955,079) from the Henry M. Jackson Foundation for the
Advancement of Military Medicine, and the Patent and Trademark Office
requested FDA's assistance in determining the patents' eligibility for
patent term restoration. In a letter dated March 4, 2013, FDA advised
the Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of MENHIBRIX
represented the first permitted commercial marketing or use of the
product. Thereafter, the Patent and Trademark Office requested that FDA
determine the product's regulatory review period.
    FDA has determined that the applicable regulatory review period for
MENHIBRIX is 2,924 days. Of this time, 1,886 days occurred during the
testing phase of the regulatory review period, while 1,038 days
occurred during the approval phase. These periods of time were derived
from the following dates:
    1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 355(i)) became effective: June 14,
2004. The applicant claims June 12, 2004, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was June 14, 2004,
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): August 12, 2009. FDA has verified the
applicant's claim that the biologics license application (BLA) for
MENHIBRIX (BLA 125363) was initially submitted on August 12, 2009.
    3. The date the application was approved: June 14, 2012. FDA has
verified the applicant's claim that BLA 125363 was approved on June 14,
2012.
    This determination of the regulatory review period establishes the
maximum potential length of a patent extension. However, the Patent and
Trademark Office applies several statutory limitations in its
calculations of the actual period for patent extension. In its
applications for patent extension, this applicant seeks 1,825 days of
patent term extension.
    Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by July 28, 2014. Furthermore, any interested person
may petition FDA for a determination regarding whether the applicant
for extension acted with due diligence during the regulatory review
period by November 24, 2014. To meet its burden, the petition must
contain sufficient facts to merit an FDA investigation. (See H. Rept.
857, part 1, 98th Cong., 2d sess., pp. 41-42, 1984.) Petitions should
be in the format specified in 21 CFR 10.30.
    Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12294 Filed 5-27-14; 8:45 am]
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