80 FR 50762 - Listing of Color Additives Exempt From Certification; Spirulina Extract

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 162 (August 21, 2015)

Page Range		50762-50765
FR Document		2015-20676

The Food and Drug Administration (FDA or we) is amending the color additive regulations to provide for the safe use of spirulina extract as a color additive in coating formulations applied to dietary supplement and drug tablets and capsules. This action is in response to a petition filed by Colorcon, Inc. (Colorcon).

Federal Register, Volume 80 Issue 162 (Friday, August 21, 2015)

[Federal Register Volume 80, Number 162 (Friday, August 21, 2015)]
[Rules and Regulations]
[Pages 50762-50765]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-20676]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2014-C-1552]

Listing of Color Additives Exempt From Certification; Spirulina
Extract

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA or we) is amending the
color additive regulations to provide for the safe use of spirulina
extract as a color additive in coating formulations applied to dietary
supplement and drug tablets and capsules. This action is in response to
a petition filed by Colorcon, Inc. (Colorcon).

DATES: This rule is effective September 22, 2015. See section IX for
information on the filing of objections. Submit either electronic or
written objections and requests for a hearing by September 21, 2015.

ADDRESSES: You may submit either electronic or written objections and
requests for a hearing, identified by Docket No. FDA-2014-C-1552, by
any of the following methods:

Electronic Submissions

Submit electronic objections in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.

Written Submissions

Submit written objections in the following ways:
Mail/Hand delivery/Courier (for paper submissions):
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the Agency name
and Docket No. FDA-2014-C-1552 for this rulemaking. All objections
received will be posted without change to http://www.regulations.gov,
including any personal information provided. For detailed instructions
on submitting objections, see the ``Objections'' heading of the
SUPPLEMENTARY INFORMATION section.
Docket: For access to the docket to read background documents or
objections received, go to http://www.regulations.gov and insert the
docket number, found in brackets in the

[[Page 50763]]

heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Molly A. Harry, Center for Food Safety
and Applied Nutrition (HFS-265), Food and Drug Administration, 5100
Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1075.

SUPPLEMENTARY INFORMATION:

I. Introduction

In a notice published in the Federal Register of October 22, 2014
(79 FR 63062), we announced that we had filed a color additive petition
(CAP 4C0300), submitted by Colorcon, Inc. (petitioner), 275 Ruth Rd.,
Harleysville, PA 19438. The petition proposed to amend the color
additive regulations in Title 21, Code of Federal Regulations (CFR)
part 73 Listing of Color Additives Exempt From Certification to provide
for the safe use of spirulina extract, prepared by the filtered aqueous
extraction of the dried biomass of Arthrospira platensis (A.
platensis), as a color additive in coating formulations applied to
dietary supplement and drug tablets and capsules.

II. Background

In the Federal Register of August 13, 2013 (78 FR 49117), we issued
a final rule in response to a color additive petition (CAP 2C0293)
approving the use of a filtered aqueous extract of the dried biomass of
A. platensis as a color additive in candy and chewing gum at levels
consistent with good manufacturing practice (GMP). We established
spirulina extract as the common or usual name for the color additive
and listed it in Sec. 73.530 (21 CFR 73.530). In addition to the
identity of the color additive, the regulation in Sec. 73.530 includes
specifications that must be met for lead, arsenic, mercury, and
microcystin toxin.
In the Federal Register of April 11, 2014 (79 FR 20095), we issued
a final rule in response to a color additive petition (CAP 2C0297)
amending Sec. 73.530 to include the use of spirulina extract as a
color additive in confections (including candy and chewing gum),
frostings, ice cream and frozen desserts, dessert coatings and
toppings, beverage mixes and powders, yogurts, custards, puddings,
cottage cheese, gelatin, breadcrumbs, and ready-to-eat cereals
(excluding extruded cereals), at levels consistent with GMP.
The spirulina extract used for the purposes of CAP 4C0300 is a
blue-colored powder produced by the filtered aqueous extraction of the
spray-dried biomass of A. platensis (also known as Spirulina
platensis), an edible blue-green cyanobacterium. The color additive
contains phycocyanins as the principal coloring component. The maximum
phycocyanin content of the color additive is 28 percent. Based on data
and information provided in the petition on the identity, physical and
chemical properties, manufacturing process, and composition of the
color additive, we have determined that the color additive meets the
specifications for spirulina extract in Sec. 73.530 (Ref. 1).
Spirulina extract is intended to be used as a color additive in
film coating formulations applied to dietary supplement and drug
tablets and capsules in amounts consistent with GMP. The maximum GMP
use level for spirulina extract in an individual coating will be
determined by the desired coloring effect. Therefore, because the
amount of the color additive used in these coatings is self-limiting,
we have determined that there is no need for a specific upper limit on
the percent by weight of spirulina extract in coating formulations
applied to dietary supplement and drug tablets and capsules (Ref. 1).

III. Safety Evaluation

A. Determination of Safety

Under section 721(b)(4) of the Federal Food, Drug, and Cosmetic Act
(the FD&C Act) (21 U.S.C. 379e(b)(4)), a color additive may not be
listed for a particular use unless the data and information available
to FDA establish that the color additive is safe for that use. Our
color additive regulations at 21 CFR 70.3(i) define ``safe'' to mean
that there is convincing evidence that establishes with reasonable
certainty that no harm will result from the intended use of the color
additive. To establish with reasonable certainty that a color additive
intended for use in food is not harmful under its intended conditions
of use, we consider the projected human dietary exposure to the
additive, the additive's toxicological data, and other relevant
information (such as published literature) available to us. We compare
an individual's estimated exposure, or estimated daily intake (EDI), of
the additive from all food sources to an acceptable daily intake level
established by toxicological data. The EDI is determined by projections
based on the amount of the additive proposed for use in particular
foods or drugs and on data regarding the amount consumed from all
ingested sources of the additive. We commonly use the EDI for the 90th
percentile consumer of a color additive as a measure of high chronic
exposure.

B. Safety of Petitioned Use of the Color Additive

To support the safety of the petitioned use of spirulina extract as
a color additive in coating formulations applied to dietary supplement
and drug tablets and capsules, Colorcon submitted an exposure estimate
for phycocyanins (the principal coloring component). Colorcon estimated
that the petitioned use of spirulina extract in coating formulations
applied to dietary supplement and drug tablets and capsules will result
in an exposure to phycocyanins of 20.9 milligrams/person/day (mg/p/d)
for the 90th percentile consumer (Ref. 2). We agree with Colorcon's
exposure estimate for phycocyanins and conclude that it is sufficiently
conservative (Ref. 2).\1\
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\1\ The petition referred to both ``drug tablets and capsules''
and ``pharmaceutical tablets and capsules.'' The term
``pharmaceutical tablets and capsules'' was used regarding the
exposure assessment (Ref. 2).
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Regarding cumulative exposure (cumulative EDI, or CEDI) to
phycocyanins from spirulina and spirulina-derived substances, FDA
discussed in the final rule for use of spirulina extract as a color
additive in candy and chewing gum that spirulina and spirulina-derived
substances have been the subject of four notices submitted by firms to
FDA informing us of their determinations that certain uses of
spirulina-derived substances are generally recognized as safe (GRAS)
(78 FR 49117 at 49118). One of the GRAS notices (GRN 000424) pertains
to the use of a spirulina-derived substance similar in chemical
composition to the subject color additive but with a much higher
phycocyanin content ranging from 42 to 47 percent, and included use in
all foods (except infant formula and foods under U.S. Department of
Agriculture's jurisdiction) at levels consistent with GMP. The upper
bound CEDI for phycocyanins resulting from the notified uses of
spirulina extract was estimated to be 1,140 mg/p/d in GRN 000424 based
on conservative assumptions (Ref. 3). This exposure estimate does not
appear to include exposure to phycocyanins from use of spirulina
extract in dietary supplements. Colorcon estimated that the use of
spirulina extract in coating formulations applied to dietary supplement
and drug tablets and capsules would increase the previously estimated
upper bound CEDI of phycocyanins by 1.8 percent. We agree that
Colorcon's estimate is conservative, and that the petitioned use of
spirulina

[[Page 50764]]

extract would not contribute significantly to the previously estimated
upper bound CEDI of 1,140 mg/p/d for phycocyanins (Ref. 2).
In support of safety of the use of spirulina extract as a color
additive in coating formulations applied to dietary supplement and drug
tablets and capsules in the subject petition, Colorcon referenced the
safety determinations made by FDA for CAP 2C0293 (78 FR 49117) and CAP
2C0297 (79 FR 20095). The petitioner also conducted a search of the
peer-reviewed scientific literature for animal and human oral
consumption studies that tested spirulina, spirulina-derived
ingredients, and phycocyanins that have been published since 2011. The
petitioner submitted the published animal and human studies that they
had identified as being relevant to their petition. We reviewed the
relevant studies and determined that these publications did not raise
any safety concerns.
In our previous evaluations of the use of spirulina extract as a
color additive in food, we had selected as the pivotal safety study a
21-month chronic feeding study that tested spirulina powder in rats at
dietary concentrations of 10, 20, or 30 percent (equivalent to 5,000,
10,000, or 15,000 milligrams per kilogram bodyweight per day (mg/kg bw/
d)). The results of this study showed that prolonged oral consumption
of spirulina powder up to a dietary concentration of 15,000 mg/kg bw/d
was without adverse effects. Therefore, we concluded that the no-
observed-effect level (NOEL) for spirulina is 15,000 mg/kg bw/d
(900,000 mg/p/d for a 60 kg person) based on the absence of treatment-
related adverse effects at the highest concentration tested in this
study. We had also determined the NOEL for phycocyanins for humans to
be between 108,000 and 184,500 mg/p/d (78 FR 49117 at 49119). Taking
into account all the available safety information, the estimated
exposure to phycocyanins from the petitioned use of the spirulina
extract, and the margin of safety between the CEDI for phycocyanin
(1,140 mg/p/d) and the NOEL for phycocyanin (108,000 to 184,500 mg/p/
d), we conclude that the petitioned use of spirulina extract as a color
additive in coating formulations applied to dietary supplement and drug
tablets and capsules is safe (Ref. 4).
The potential allergenicity of spirulina phycocyanins was discussed
in the final rule for the use of spirulina extract as a color additive
in candy and chewing gum (78 FR 49117 at 49119). Based on our review of
a comparison of the known amino acid sequences of phycocyanins with the
sequences of known protein allergens, we had determined that there is a
low probability that phycocyanins are protein allergens. We therefore
concluded that the spirulina phycocyanins present an insignificant
allergy risk to consumers of the color additive. We are not aware of
any new information that would cause us to change this conclusion.

IV. Conclusion

Based on the data and information in the petition and other
relevant material, we conclude that the petitioned use of spirulina
extract in coating formulations applied to dietary supplement and drug
tablets and capsules is safe. We further conclude that the additive
will achieve its intended technical effect and is suitable for the
petitioned use. Consequently, we are amending the color additive
regulations in part 73 as set forth in this document. In addition,
based upon the factors listed in 21 CFR 71.20(b), we conclude that
certification of spirulina extract is not necessary for the protection
of the public health.

V. Public Disclosure

In accordance with Sec. 71.15 (21 CFR 71.15), the petition and the
documents that we considered and relied upon in reaching our decision
to approve the petition will be made available for public disclosure
(see FOR FURTHER INFORMATION CONTACT). As provided in Sec. 71.15, we
will delete from the documents any materials that are not available for
public disclosure.

VI. Environmental Impact

We previously considered the environmental effects of this rule, as
stated in the October 22, 2014, notice of filing for CAP 4C0300. We
stated that we had determined, under 21 CFR 25.32(r), that this action
``is of a type that does not individually or cumulatively have a
significant effect on the human environment'' such that neither an
environmental assessment nor an environmental impact statement is
required. We have not received any new information or comments that
would affect our previous determination.

VII. Paperwork Reduction Act of 1995

This final rule contains no collection of information. Therefore,
clearance by the Office of Management and Budget under the Paperwork
Reduction Act of 1995 is not required.

VIII. Section 301(ll) of the FD&C Act

Our review of this petition was limited to section 721 of the FD&C
Act. This final rule is not a statement regarding compliance with other
sections of the FD&C Act. For example, section 301(ll) of the FD&C Act
(21 U.S.C. 331(ll) prohibits the introduction or delivery for
introduction into interstate commerce of any food that contains a drug
approved under section 505 of the FD&C Act (21 U.S.C. 355), a
biological product licensed under section 351 of the Public Health
Service Act (42 U.S.C. 262), or a drug or biological product for which
substantial clinical investigations have been instituted and their
existence has been made public, unless one of the exemptions in section
301(ll)(1) to (4) of the FD&C Act applies. In our review of this
petition, we did not consider whether section 301(ll) of the FD&C Act
or any of its exemptions apply to food containing this color additive.
Accordingly, this final rule should not be construed to be a statement
that a food containing this color additive, if introduced or delivered
for introduction into interstate commerce, would not violate section
301(ll) of the FD&C Act. Furthermore, this language is included in all
color additive final rules that pertain to food and therefore should
not be construed to be a statement of the likelihood that section
301(ll) of the FD&C Act applies.

IX. Objections

This rule is effective as shown in the DATES section except as to
any provisions that may be stayed by the filing of proper objections.
If you will be adversely affected by one or more provisions of this
regulation, you may file with the Division of Dockets Management (see
ADDRESSES) either electronic or written objections. You must separately
number each objection, and within each numbered objection you must
specify with particularity the provision(s) of the regulation to which
you object, and the grounds for your objection. Within each numbered
objection, you must specifically state whether you are requesting a
hearing on the particular provision that you specify in that numbered
objection. If you do not request a hearing for any particular
objection, you waive the right to a hearing on that objection. If you
request a hearing, your objection must include a detailed description
and analysis of the specific factual information you intend to present
in support of the objection in the event that a hearing is held. If you
do not include such a description and analysis for any particular
objection, you waive the right to a hearing on the objection.
It is only necessary to send one set of documents. Identify
documents with the

[[Page 50765]]

docket number found in brackets in the heading of this document. Any
objections received in response to the regulation may be seen in the
Division of Dockets Management between 9 a.m. and 4 p.m., Monday
through Friday, and will be posted to the docket at http://www.regulations.gov. We will publish notice of the objections that we
have received or lack thereof in the Federal Register.

X. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday,
and are available electronically at http://www.regulations.gov. (FDA
has verified the Web site address in this reference section, but FDA is
not responsible for any subsequent changes to the Web site after this
document publishes in the Federal Register).

1. Memorandum from N. Belai, Color Technology Team, OCAC, CFSAN, FDA
to M. Harry, Division of Petition Review, OFAS, CFSAN, FDA, March
19, 2015.
2. Memorandum from H. Lee, Division of Petition Review, OFAS, CFSAN,
FDA to M. Harry, Division of Petition Review, OFAS, CFSAN, FDA,
January 30, 2015.
3. Letter from D. Keefe, Office of Food Additive Safety, CFSAN, FDA
to H. Newman, Desert Lake Technologies, LLC, Agency Response Letter
GRAS Notice 000424, December 6, 2012, (http://www.fda.gov/Food/IngredientsPackagingLabeling/GRAS/NoticeInventory/ucm335743.htm).
4. Memorandum from T. Walker, Division of Petition Review, OFAS,
CFSAN, FDA to M. Harry, Division of Petition Review, OFAS, CFSAN,
FDA, April 2, 2015.

List of Subjects in 21 CFR Part 73

Color additives, Cosmetics, Drugs, Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and re-
delegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 73 is amended as follows:

PART 73--LISTING OF COLOR ADDITIVES EXEMPT FROM CERTIFICATION

0
1. The authority citation for 21 CFR part 73 continues to read as
follows:

Authority: 21 U.S.C. 321, 341, 342, 343, 348, 351, 352, 355,
361, 362, 371, 379e.

0
2. Section 73.530 is amended by revising paragraph (c) to read as
follows:

Sec. 73.530 Spirulina extract.

* * * * *
(c) Uses and restrictions. Spirulina extract may be safely used for
coloring confections (including candy and chewing gum), frostings, ice
cream and frozen desserts, dessert coatings and toppings, beverage
mixes and powders, yogurts, custards, puddings, cottage cheese,
gelatin, breadcrumbs, ready-to-eat cereals (excluding extruded
cereals), and coating formulations applied to dietary supplement
tablets and capsules, at levels consistent with good manufacturing
practice, except that it may not be used to color foods for which
standards of identity have been issued under section 401 of the Federal
Food, Drug, and Cosmetic Act, unless the use of the added color is
authorized by such standards.
* * * * *

0
3. Section 73.1530 is added to subpart B to read as follows:

Sec. 73.1530 Spirulina extract.

(a) Identity. (1) The color additive spirulina extract is prepared
by the filtered aqueous extraction of the dried biomass of Arthrospira
platensis. The color additive contains phycocyanins as the principal
coloring components.
(2) Color additive mixtures for drug use made with spirulina
extract may contain only those diluents that are suitable and are
listed in this subpart as safe for use in color additive mixtures for
coloring ingested drugs.
(b) Specifications. Spirulina extract must conform to the following
specifications and must be free from impurities, other than those
named, to the extent that such other impurities may be avoided by good
manufacturing practice:
(1) Lead, not more than 2 milligrams per kilogram (mg/kg) (2 parts
per million (ppm));
(2) Arsenic, not more than 2 mg/kg (2 ppm);
(3) Mercury, not more than 1 mg/kg (1 ppm); and
(4) Negative for microcystin toxin.
(c) Uses and restrictions. Spirulina extract may be safely used for
coloring coating formulations applied to drug tablets and capsules, at
levels consistent with good manufacturing practice.
(d) Labeling requirements. The label of the color additive and any
mixture prepared therefrom intended solely or in part for coloring
purposes shall conform to the requirements of Sec. 70.25 of this
chapter.
(e) Exemption from certification. Certification of this color
additive is not necessary for the protection of the public health, and
therefore batches thereof are exempt from the certification
requirements of section 721(c) of the Federal Food, Drug, and Cosmetic
Act.

Dated: August 14, 2015.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2015-20676 Filed 8-20-15; 8:45 am]
BILLING CODE 4164-01-P

50762 Federal Register / Vol. 80, No. 162 / Friday, August 21, 2015 / Rules and Regulations

to the list of countries with which DOD assistance. DOD may seek such DEPARTMENT OF HEALTH AND
has such arrangements. The list is prioritization and persons in the United HUMAN SERVICES
informational only and does not affect States may request DOD assistance
any right, duty or prohibition that regardless whether or not the countries Food and Drug Administration
applies to any person under the DPAS with which DOD has entered into
Regulations. DOD would be able to security of supply arrangements are 21 CFR Part 73
request priority delivery in countries identified in the DPAS Regulations.
[Docket No. FDA–2014–C–1552]
with which it has security of supply Listing these countries in the DPAS
arrangements and persons in the United Regulations does not affect any right, Listing of Color Additives Exempt
States would be able to request duty or prohibition that applies to any From Certification; Spirulina Extract
assistance from DOD in obtaining person under those regulations. Because
priority delivery even if the list did not these revisions are not substantive AGENCY: Food and Drug Administration,
appear in the DPAS Regulations. changes, it is unnecessary to provide HHS.
With the addition of Spain, the list notice and opportunity for public ACTION: Final rule.
will read: Australia, Finland, Italy, The comment. Because neither the
Netherlands, Spain, Sweden and the Administrative Procedure Act nor any SUMMARY: The Food and Drug
United Kingdom. other law requires that notice and an Administration (FDA or we) is
Rulemaking Requirements opportunity for public comment be amending the color additive regulations
given for this rule, the analytical to provide for the safe use of spirulina
1. Executive Orders 13563 and 12866 requirements of the Regulatory extract as a color additive in coating
direct agencies to assess all costs and Flexibility Act (5 U.S.C. 601 et seq.) are formulations applied to dietary
benefits of available regulatory not applicable. supplement and drug tablets and
alternatives and, if regulation is capsules. This action is in response to
necessary, to select regulatory In addition, the 30-day delay in
effectiveness otherwise required by 5 a petition filed by Colorcon, Inc.
approaches that maximize net benefits (Colorcon).
(including potential economic, U.S.C. 553(d) is not applicable because
environmental, public health and safety this rule is not a substantive rule. DATES: This rule is effective September
effects, distributive impacts, and 22, 2015. See section IX for information
List of Subjects in 15 CFR Part 700
equity). This rule does not impose any on the filing of objections. Submit either
regulatory burden on the public and is Administrative practice and electronic or written objections and
consistent with the goals of Executive procedure, Business and industry, requests for a hearing by September 21,
Order 13563. This rule has been Government contracts, National defense, 2015.
determined not to be significant for Reporting and recordkeeping ADDRESSES: You may submit either
purposes of Executive Order 12866. requirements, Strategic and critical electronic or written objections and
2. Notwithstanding any other materials. requests for a hearing, identified by
provision of law, no person is required Docket No. FDA–2014–C–1552, by any
For the reasons set forth in the
to respond to, nor shall any person be of the following methods:
preamble, the Defense Priorities and
subject to a penalty for failure to comply
Allocations System Regulations (15 CFR Electronic Submissions
with, a collection of information subject
part 700) are amended as follows:
to the requirements of the Paperwork Submit electronic objections in the
Reduction Act of 1995 (44 U.S.C. 3501 PART 700—[AMENDED] following way:
et seq.), unless that collection of • Federal eRulemaking Portal: http://
information displays a currently valid ■ 1. The authority citation for 15 CFR www.regulations.gov. Follow the
Office of Management and Budget part 700 continues to read as follows: instructions for submitting comments.
control number. This rule does not Written Submissions
Authority: 50 U.S.C. App. 2061, et seq.; 42
involve a collection of information that
U.S.C. 5195, et seq.; 50 U.S.C. App 468; 10 Submit written objections in the
is subject to the Paperwork Reduction U.S.C. 2538; 50 U.S.C. 82; E.O. 12656, 53 FR
Act. 226, 3 CFR, 1988, Comp. 585; E.O. 12742, 56
following ways:
3. This rule does not contain policies FR 1079, 3 CFR, 1991 Comp. 309; E.O. 13603, • Mail/Hand delivery/Courier (for
with Federalism implications as that 77 FR 16651, 3 CFR, 2012 Comp., p. 225. paper submissions): Division of Dockets
term is defined under Executive Order Management (HFA–305), Food and Drug
13132. § 700.57 [Amended] Administration, 5630 Fishers Lane, Rm.
4. BIS finds good cause under 5 U.S.C. 1061, Rockville, MD 20852.
■ 2. Section 700.57 is amended by
553(b)(B) to waive prior notice of Instructions: All submissions received
adding ‘‘Spain’’ after ‘‘The
proposed rulemaking and the must include the Agency name and
Netherlands,’’ in:
opportunity for public comment Docket No. FDA–2014–C–1552 for this
because it is unnecessary. This rule ■ a. The last sentence of paragraph (a); rulemaking. All objections received will
merely updates the list of countries with ■ b. The italicized heading of paragraph be posted without change to http://
which the DOD has entered into (c); www.regulations.gov, including any
security of supply arrangements and ■ c. Paragraph (c)(1); and personal information provided. For
thus may seek prioritization of contracts ■ d. The first and second sentences of
detailed instructions on submitting
in those countries. Persons in the paragraph (c)(2). objections, see the ‘‘Objections’’ heading
United States who need such of the SUPPLEMENTARY INFORMATION
rmajette on DSK7SPTVN1PROD with RULES

prioritization may request DOD Dated: August 17, 2015. section.
assistance to obtain it. The lists are in Kevin J. Wolf, Docket: For access to the docket to
the DPAS regulations to inform persons Assistant Secretary for Export read background documents or
whose need for contract prioritization Administration. objections received, go to http://
may extend beyond the United States of [FR Doc. 2015–20704 Filed 8–20–15; 8:45 am] www.regulations.gov and insert the
where they may be able to obtain BILLING CODE 3510–JT–P docket number, found in brackets in the

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Document Created: 2018-02-23 11:01:17
Document Modified: 2018-02-23 11:01:17

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Rules and Regulations
Action		Final rule.
Dates		This rule is effective September 22, 2015. See section IX for information on the filing of objections. Submit either electronic or written objections and requests for a hearing by September 21, 2015.
Contact		Molly A. Harry, Center for Food Safety and Applied Nutrition (HFS-265), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD 20740-3835, 240-402-1075.
FR Citation		80 FR 50762
CFR Associated		Color Additives; Cosmetics; Drugs and Medical Devices

80 FR 50762 - Listing of Color Additives Exempt From Certification; Spirulina Extract

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 162 (August 21, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration