Listing of Color Additives Exempt From Certification; Spirulina Extract; Confirmation of Effective Date, 68713-68714 [2013-27381]
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Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations
the patent holder to assist the recipient
of the exclusive patent rights in
developing and commercializing the
product covered by the patent. These
co-rights include, but are not limited to,
co-development, co-promotion, comarketing and co-commercialization.
■ 3. Amend § 801.2 by adding paragraph
(g) to read as follows:
§ 801.2
Acquiring and acquired persons.
emcdonald on DSK67QTVN1PROD with RULES
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(g) Transfers of patent rights within
NAICS Industry Group 3254.
(1) This paragraph applies only to
patents covering products whose
manufacture and sale would generate
revenues in NAICS Industry Group
3254, including:
325411 Medical and Botanical
Manufacturing
325412 Pharmaceutical Preparation
Manufacturing
325413 In-Vitro Diagnostic Substance
Manufacturing
325414 Biological Product (except
Diagnostic) Manufacturing
(2) The transfer of patent rights
covered by this paragraph constitutes an
asset acquisition; and
(3) Patent rights are transferred if and
only if all commercially significant
rights to a patent, as defined in
§ 801.1(o), for any therapeutic area (or
specific indication within a therapeutic
area) are transferred to another entity.
All commercially significant rights are
transferred even if the patent holder
retains limited manufacturing rights, as
defined in § 801.1(p), or co-rights, as
defined in § 801.1(q).
Examples: Although these examples
refer to licenses, which are typically
used to effect the transfer of
pharmaceutical patent rights to a
recipient of those rights, other methods
of transferring patent rights, by
assignment or grant, among others, are
similarly covered by these rules and
examples.
1. B holds a patent relating to an
active pharmaceutical ingredient for
cardiovascular use. A will obtain a
license from B that grants A the
exclusive right to all of B’s patent rights
except that both A and B can
manufacture the active pharmaceutical
ingredient to be sold by A under the
exclusive license agreement. B retains
limited manufacturing rights as defined
in § 801.1(p) because it retains the right
to manufacture the product covered by
the patent for cardiovascular use solely
to provide the product to A. A is still
receiving all commercially significant
rights to the patent, and the transfer of
these rights via the license constitutes
an asset acquisition. Further, even if B
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retained all rights to manufacture (so
that A could not manufacture), B would
still retain limited manufacturing rights,
and A would still receive all
commercially significant rights to the
patent. Thus, the transfer of these rights
via the license would also constitute an
asset acquisition.
2. B holds a patent for an in-vitro
diagnostic substance relating to arthritis.
B will grant A an exclusive license to all
of B’s patent rights for all veterinary
indications. B retains all patent rights
for all human indications. The exclusive
license to all commercially significant
rights for all veterinary indications is an
asset acquisition because A is receiving
all rights to the patent for a therapeutic
area.
3. B holds a patent relating to a
biological product. B will grant A an
exclusive license to all of B’s patent
rights in all therapeutic areas. A and B
are also entering into a co-development
and co-commercialization agreement
under which B will assist A in
developing, marketing and promoting
the product to physicians. B cannot
separately use the patent in the same
therapeutic area as A under the codevelopment and co-commercialization
agreement. A will book all sales of the
product and will pay B a portion of the
profits resulting from those sales.
Despite B’s retention of these co-rights,
A is still receiving all commercially
significant rights. The licensing
agreement is an asset acquisition. This
would be an asset acquisition even if B
also retained limited manufacturing
rights.
4. B holds a patent relating to an
active pharmaceutical ingredient and a
bulk compound that contains that active
pharmaceutical ingredient. B will grant
A an exclusive license to use the bulk
compound to manufacture and sell a
finished product in the neurological
therapeutic area. B cannot manufacture
the active pharmaceutical ingredient or
bulk compound for any other finished
products in the neurological area, but it
can manufacture either for use by
another party in a different therapeutic
area. Despite B’s retention of
manufacturing rights of the active
pharmaceutical ingredient and bulk
compound for therapeutic areas other
than neurology, A is still receiving all
commercially significant rights in a
therapeutic area and the licensing
agreement is the acquisition of an asset.
5. B holds a patent related to a
pharmaceutical product that has been
approved by the FDA. B will enter into
an exclusive distribution agreement
with A that will give A the right to
distribute the product in the U.S. B will
manufacture the product for A and will
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68713
receive a portion of all revenues from
the sale of the product. A receives no
exclusive patent rights under the
distribution agreement. A has not
obtained all commercially significant
rights to the patent because it is only
handling the logistics of selling and
distributing the product on B’s behalf.
Therefore, the exclusive distribution
agreement is not an asset acquisition.
By direction of the Commission.
Donald S. Clark,
Secretary.
[FR Doc. 2013–27027 Filed 11–14–13; 8:45 am]
BILLING CODE 6750–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA–2011–C–0878]
Listing of Color Additives Exempt
From Certification; Spirulina Extract;
Confirmation of Effective Date
AGENCY:
Food and Drug Administration,
HHS.
Final rule; confirmation of
effective date.
ACTION:
The Food and Drug
Administration (FDA or we) is
confirming the effective date of
September 13, 2013, for the final rule
that appeared in the Federal Register of
August 13, 2013. The final rule
amended the color additive regulations
to provide for the safe use of spirulina
extract made from the dried biomass of
the cyanobacteria Arthrospira platensis
(A. platensis), as a color additive in
candy and chewing gum.
DATES: The effective date for the final
rule published August 13, 2013 (78 FR
49117), is confirmed as September 13,
2013.
SUMMARY:
FOR FURTHER INFORMATION CONTACT:
Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS–
265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park,
MD 20740–3835, 240–402–1264.
SUPPLEMENTARY INFORMATION: In the
Federal Register of August 13, 2013 (78
FR 49117), we amended the color
additive regulations to add § 73.530
Spirulina extract (21 CFR 73.530) to
provide for the safe use of spirulina
extract made from the dried biomass of
the cyanobacteria A. platensis, as a color
additive in candy and chewing gum.
We gave interested persons until
September 12, 2013, to file objections or
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68714
Federal Register / Vol. 78, No. 221 / Friday, November 15, 2013 / Rules and Regulations
requests for a hearing. We received no
objections or requests for a hearing on
the final rule. Therefore, we find that
the effective date of the final rule that
published in the Federal Register of
August 13, 2013, should be confirmed.
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 2414, Silver Spring,
MD 20993–0002, 301–796–6860,
Tina.Kiang@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs,
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321,
341, 342, 343, 348, 351, 352, 355, 361,
362, 371, 379 e) and under authority
delegated to the Commissioner of Food
and Drugs, and redelegated to the
Director, Office of Food Additive Safety,
we are giving notice that no objections
or requests for a hearing were filed in
response to the August 13, 2013, final
rule. Accordingly, the amendments
issued thereby became effective
September 13, 2013.
I. Background
The Federal Food, Drug, and Cosmetic
Act (the FD&C Act) (21 U.S.C. 301 et
seq.), as amended by the Medical Device
Amendments of 1976 (the 1976
amendments) (Pub. L. 94–295), the Safe
Medical Devices Act of 1990 (Pub. L.
101–629), the Food and Drug
Administration Modernization Act of
1997 (FDAMA) (Pub. L. 105–115),
Medical Device User Fee and
Modernization Act of 2002 (MDUFMA)
(Pub. L. 107–250), Food and Drug
Administration Amendments Act of
2007 (FDAAA) (Pub. L. 110–85), and
Food and Drug Administration Safety
and Innovation Act (FDASIA) (Pub. L.
112–144), among other amendments,
established a comprehensive system for
the regulation of medical devices
intended for human use. Section 513 of
the FD&C Act (21 U.S.C. 360c)
established three categories (classes) of
devices, depending on the regulatory
controls needed to provide reasonable
assurance of their safety and
effectiveness. The three categories of
devices are class I (general controls),
class II (special controls), and class III
(premarket approval).
Under section 513 of the FD&C Act,
FDA refers to devices that were in
commercial distribution before May 28,
1976 (the date of enactment of the 1976
amendments), as ‘‘preamendments
devices.’’ FDA classifies these devices
after the Agency takes the following
steps: (1) Receives a recommendation
from a device classification panel (an
FDA advisory committee); (2) publishes
the panel’s recommendation for
comment, along with a proposed
regulation classifying the device; and (3)
publishes a final regulation classifying
the device. FDA has classified most
preamendments devices under these
procedures.
FDA refers to devices that were not in
commercial distribution before May 28,
1976, as ‘‘postamendments devices.’’
These devices are classified
automatically by statute (section 513(f)
of the FD&C Act) into class III without
any FDA rulemaking process. These
devices remain in class III and require
premarket approval, unless and until:
(1) FDA reclassifies the device into class
I or II; (2) FDA issues an order
classifying the device into class I or II
in accordance with section 513(f)(2) of
the FD&C Act, as amended by FDAMA;
or (3) FDA issues an order finding the
Dated: November 8, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and
Social Sciences, Center for Food Safety and
Applied Nutrition.
[FR Doc. 2013–27381 Filed 11–14–13; 8:45 am]
BILLING CODE 4160–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Part 886
[Docket No. FDA–2012–N–1238]
Medical Devices; Ophthalmic Devices;
Classification of the Scleral Plug
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
The Food and Drug
Administration (FDA or Agency) is
classifying the scleral plug into class II
(special controls), and exempting the
scleral plugs composed of surgical grade
stainless steel (with or without coating
in gold, silver, or titanium) from
premarket notification (510(k)) and
continuing to require premarket
notification (510(k)) for all other scleral
plugs in order to provide a reasonable
assurance of safety and effectiveness of
the device. The scleral plug is a
prescription device used to provide
temporary closure of a scleral incision
during an ophthalmic surgical
procedure.
DATES: This final rule is effective on
December 16, 2013.
FOR FURTHER INFORMATION CONTACT: Tina
Kiang, Center for Devices and
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SUMMARY:
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device to be substantially equivalent,
under section 513(i) of the FD&C Act, to
a predicate device that does not require
premarket approval. The Agency
determines whether new devices are
substantially equivalent to predicate
devices by means of premarket
notification procedures in section 510(k)
of the FD&C Act (21 U.S.C. 360(k)) and
part 807 of the regulations (21 CFR part
807).
A person may market a
preamendments device that has been
classified into class III through
premarket notification procedures,
without submission of a premarket
approval application (PMA) until FDA
issues a final regulation under section
515(b) of the FD&C Act (21 U.S.C.
360e(b)) requiring premarket approval.
Section 510(m) of the FD&C Act
provides that a class II device may be
exempted from the premarket
notification requirements under section
510(k) of the FD&C Act, if the Agency
determines that premarket notification
is not necessary to assure the safety and
effectiveness of the device. FDA has
determined that premarket notification
is not necessary to assure the safety and
effectiveness of scleral plugs if the
material is a surgical grade stainless
steel with or without a gold, silver, or
titanium coating.
II. Regulatory History of the Device
In the Federal Register of January 25,
2013 (78 FR 5327), FDA proposed to
classify scleral plug devices used to
provide temporary closure of a scleral
incision during an ophthalmic surgical
procedure into class II (special controls)
and proposed special controls for these
devices. FDA also proposed to exempt
the devices from premarket notification
requirements if the device is made from
surgical grade stainless steel (with or
without a gold, silver, or titanium
coating). FDA invited interested persons
to comment on the proposed regulation
by April 25, 2013. FDA received no
comments on the proposed rule.
III. Summary of Final Rule
In accordance with 21 CFR
860.84(g)(2), FDA is classifying scleral
plugs into class II (special controls).
FDA is codifying the classification of
scleral plugs by adding § 886.4155. The
Agency is also exempting these devices
from premarket notification
requirements when they are made from
surgical grade stainless steel (with or
without a gold, silver, or titanium
coating). The Agency has also identified
special controls for scleral plug devices.
Following the effective date of this final
classification rule, manufacturers will
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[Federal Register Volume 78, Number 221 (Friday, November 15, 2013)]
[Rules and Regulations]
[Pages 68713-68714]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-27381]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 73
[Docket No. FDA-2011-C-0878]
Listing of Color Additives Exempt From Certification; Spirulina
Extract; Confirmation of Effective Date
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule; confirmation of effective date.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or we) is confirming the
effective date of September 13, 2013, for the final rule that appeared
in the Federal Register of August 13, 2013. The final rule amended the
color additive regulations to provide for the safe use of spirulina
extract made from the dried biomass of the cyanobacteria Arthrospira
platensis (A. platensis), as a color additive in candy and chewing gum.
DATES: The effective date for the final rule published August 13, 2013
(78 FR 49117), is confirmed as September 13, 2013.
FOR FURTHER INFORMATION CONTACT: Felicia M. Ellison, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1264.
SUPPLEMENTARY INFORMATION: In the Federal Register of August 13, 2013
(78 FR 49117), we amended the color additive regulations to add Sec.
73.530 Spirulina extract (21 CFR 73.530) to provide for the safe use of
spirulina extract made from the dried biomass of the cyanobacteria A.
platensis, as a color additive in candy and chewing gum.
We gave interested persons until September 12, 2013, to file
objections or
[[Page 68714]]
requests for a hearing. We received no objections or requests for a
hearing on the final rule. Therefore, we find that the effective date
of the final rule that published in the Federal Register of August 13,
2013, should be confirmed.
List of Subjects in 21 CFR Part 73
Color additives, Cosmetics, Drugs, Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act (21
U.S.C. 321, 341, 342, 343, 348, 351, 352, 355, 361, 362, 371, 379 e)
and under authority delegated to the Commissioner of Food and Drugs,
and redelegated to the Director, Office of Food Additive Safety, we are
giving notice that no objections or requests for a hearing were filed
in response to the August 13, 2013, final rule. Accordingly, the
amendments issued thereby became effective September 13, 2013.
Dated: November 8, 2013.
Susan M. Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2013-27381 Filed 11-14-13; 8:45 am]
BILLING CODE 4160-01-P
