[Federal Register: November 16, 2009 (Volume 74, Number 219)]
[Rules and Regulations]
[Page 58843-58846]
[DOCID:fr16no09-1]

========================================================================
Rules and Regulations
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains regulatory documents
having general applicability and legal effect, most of which are keyed
to and codified in the Code of Federal Regulations, which is published
under 50 titles pursuant to 44 U.S.C. 1510.

The Code of Federal Regulations is sold by the Superintendent of Documents.
Prices of new books are listed in the first FEDERAL REGISTER issue of each
week.

========================================================================

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 73

[Docket No. FDA-2007-C-0456] (formerly Docket No. 2007-C-0245)

Listing of Color Additives Exempt From Certification; Paracoccus
Pigment

AGENCY:  Food and Drug Administration, HHS.

ACTION: Final rule.

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

SUMMARY:  The Food and Drug Administration (FDA) is amending the color
additive regulations to provide for the safe use of paracoccus pigment
as a color additive in the feed of salmonid fish to enhance the color
of their flesh. This action is in response to a petition filed by
Nippon Oil Corp.

DATES:  This rule is effective December 17, 2009, except as to any
provisions that may be stayed by the filing of proper objections.
Submit electronic or written objections and requests for a hearing by
December 16, 2009. See section X of this document for information on
the filing of objections.

ADDRESSES:  You may submit electronic or written objections and
requests for a hearing identified by Docket No. FDA-2007-C-0456, 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:
     FAX:<PHONE_NUMBER>.
     Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    To ensure more timely processing of objections, FDA is no longer
accepting objections submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic objections by using the Federal
eRulemaking Portal, as described previously, in the ADDRESSES portion
of this document under Electronic Submissions.
    Instructions: All submissions received must include the agency name
and docket number 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 of this document.
    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 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: Mical E. Honigfort, Center for Food
Safety and Applied Nutrition (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In a notice published in the Federal Register of July 9, 2007 (72
FR 37243), FDA announced that a color additive petition (CAP 7C0283)
had been filed by Nippon Oil Corp., c/o Beckloff Associates, 7400 West
110th St. suite 300, Overland Park, KS 66210. The petition proposed to
amend the color additive regulations in part 73 (21 CFR part 73) to
provide for the safe use of Paracoccus carotinifaciens (P.
carotinifaciens) granules as a color additive in the feed of salmonid
fish to enhance the color of their flesh. This color additive is
commonly known as paracoccus pigment. Therefore, the agency is
establishing paracoccus pigment as the common or usual name for this
color additive.

II. Identity, Technical Effect, and Specifications

    Paracoccus pigment consists of cells of the bacterium P.
carotinifaciens that are produced by fermentation, and then killed by
heat. The major components of the dried cells are proteins,
carbohydrates, and lipids. The cells may be mixed with calcium
carbonate added as necessary to yield a granular solid that contains at
least 1.75 percent (weight/weight) astaxanthin and lesser amounts of
other carotenoids as coloring agents. Calcium carbonate is added to
adjust the astaxanthin content to the appropriate level in the final
pigment. The primary coloring substance in paracoccus pigment is
astaxanthin, which is typically present in the color additive at an
average concentration of 2.18 percent, and represents approximately 51
percent of the total carotenoids present. The approximate levels of
other carotenoids present in paracoccus pigment at lower levels that
contribute to the color of the salmonid flesh are adonirubin (30
percent), canthaxanthin (10 percent), adonixanthin (4 percent), and
asteroidenone (2 percent). When fed to salmonid fish, the petitioned
use of paracoccus pigment results in deposition of very small amounts
of carotenoids in the flesh of the fish. Studies included in the
petition showed that paracoccus pigment at the intended level of use
satisfactorily pigmented the flesh of the fish to levels comparable to
that in wild salmonids.
    In the Federal Register of April 13, 1995 (60 FR 18736), the agency
published a final rule that listed astaxanthin in Sec.  73.35 (21 CFR
73.35) for use in the feed of salmonid fish. In that final rule, the
agency concluded that 80 milligrams (mg) of astaxanthin per (/)
kilogram (kg) of finished feed would result in adequate pigmentation of
the flesh of salmonid fish. Therefore, in Sec.  73.35(c)(2), the agency
limited the astaxanthin content of finished feed to not more than 80
mg/kg. In the Federal Register of July 6, 2000, the agency published
final rules that listed haematococcus algae meal in Sec.  73.185 (65 FR
41581) and phaffia yeast in Sec.  73.355 (65 FR 41584) as additional
sources of astaxanthin for use in the feed of salmonid fish. Both

haematococcus algae meal and phaffia yeast may be used alone or in
combination with other astaxanthin color additive sources, provided
that the quantity of astaxanthin in the finished feed does not exceed
80 mg/kg. Canthaxanthin also is listed for use as a color additive in
salmonid fish feed with a limit of 80 mg/kg of finished feed (Sec.
73.75).
    Consistent with these other listings, the petitioner proposes that
the maximum amount of astaxanthin in finished feed from the use of
paracoccus pigment not exceed 80 mg/kg and has requested that this
level be specified in the listing regulation. Because of the other
listed sources of astaxanthin and other color additives that are
sources of astaxanthin the agency may list in the future, new Sec.
73.352(c)(2) requires that the quantity of astaxanthin in finished
feed, from paracoccus pigment when used alone or in combination with
other astaxanthin color additive sources listed in part 73, shall not
exceed 80 mg/kg (72 grams per ton) of finished feed.

III. Evaluation of Safety

    In evaluating the safety of the use of paracoccus pigment in fish
feed, FDA considered the safety of the paracoccus pigment to humans and
fish and the safety of the producing organism, P. carotinifaciens.

A. Safety of Paracoccus Pigment

    Because consumers are not directly exposed to the paracoccus
pigment, FDA focused its review on the safety of the carotenoids
present in the pigment that are deposited in the fish. The agency
considered the safety of astaxanthin and canthaxanthin, which are
already approved for use in the feed of salmonid fish, as well as the
safety of the other carotenoids in the pigment. Astaxanthin and
canthaxanthin are two substances found in wild salmonids that are
responsible for imparting the pink or red coloring to the flesh of
these fish. The agency has determined that the astaxanthin and
canthaxanthin from paracoccus pigment, which account for approximately
60 percent of the total carotenoids in paracoccus pigment, will
substitute for the fish feed uses of other approved color additive
sources of these carotenoids. Additionally, the agency considers the
intake of astaxanthin and canthaxanthin from the consumption of wild
salmon and the intake of astaxanthin and canthaxanthin from consumption
of farm-raised salmonid fish that have been fed approved color additive
sources of these carotenoids to be comparable. Therefore, the agency
concludes that the petitioned use of paracoccus pigment will not
increase the estimated daily intake of astaxanthin and canthaxanthin,
and that these two carotenoids are safe as components of the paracoccus
pigment in the feed of salmonid fish.
    To support the safety of the petitioned use of the subject color
additive, including the carotenoids adonirubin, adonixanthin, and
asteroidenone, the petitioner provided data from studies in which sea
bream and rainbow trout were fed feed containing paracoccus pigment at
levels up to 5 percent in the feed. The studies did not reveal any
toxicity to the target fish species. Therefore, FDA concludes that the
petitioned use of paracoccus pigment is safe to salmonid fish. The
petitioner also provided results from toxicity studies in which rats
were fed paracoccus pigment. These studies did not reveal any adverse
effects from exposure to paracoccus pigment. Importantly, consumers
will not be directly exposed to paracoccus pigment, but to carotenoids
remaining in the fish that have consumed the color additive in their
diet. Therefore, based on the exposure estimates for the individual
carotenoids, the results from the fish and rat toxicity studies and
genetic toxicity tests, as well as previous safety determinations
regarding the use of astaxanthin and canthaxanthin in salmonid fish
feed, FDA concludes that there is a reasonable certainty of no harm to
consumers from the petitioned use of paracoccus pigment.

B. Safety of the Producing Organism, P. carotinifaciens

    FDA reviewed the pathogenicity, toxigenic potential, and
antimicrobial activity of the producing organism, P. carotinifaciens.
The heat treatment during production of paracoccus pigment ensures that
no viable P. carotinifaciens cells will be in the final product and
ensures that there is no pathogenic or toxigenic potential of P.
carotinifaciens in the production of paracoccus pigment. In addition,
as a condition of safe use, FDA is requiring that only a nonpathogenic
and nontoxicogenic strain of the bacterium P. carotinifaciens be used
in the production of paracoccus pigment. FDA also reviewed a study that
provided evidence that the strain of P. carotinifaciens used to produce
paracoccus pigment is not capable of producing antibiotics. Based on
this information and the fact that consumers will not be directly
exposed to paracoccus pigment, but to carotenoids remaining in the fish
that have consumed the pigment, FDA concludes that the petitioned use
of P. carotinifaciens in the production of paracoccus pigment is safe.

IV. Labeling Requirements

    All color additives, in accordance with Sec.  70.25 (21 CFR 70.25),
are required to be labeled with sufficient information to assure their
safe use and to allow a determination of compliance with any
limitations imposed by the agency in other applicable regulations. The
labeling of the color additive, paracoccus pigment, and any mixture
prepared therefrom, is subject to the requirements of Sec.  70.25.
    According to Sec.  70.25(a)(4), an expiration date for a color
additive must be stated on its label if stability data require it. FDA
finds that because of the instability of astaxanthin in paracoccus
pigment, an expiration date must be stated on the label of sealed and
open containers, in accordance with Sec.  70.25(a)(4). FDA also finds
that declaration of the expiration date constitutes a material fact
that must be disclosed on the label of the color additive mixture under
sections 201(n) and 403(a)(1) of the Federal Food, Drug, and Cosmetic
Act (21 U.S.C. 321(n) and 343(a)(1)). Failure to disclose the material
fact on the label of the color additive mixture would constitute a
failure to reveal facts that are: (1) Material in light of the
representations made on the label and (2) material with respect to
consequences which may result from the use of the color additive. The
use of paracoccus pigment requires the declaration of expiration dates
because astaxanthin in paracoccus pigment is unstable and can
decompose, thereby affecting the efficacy of the color.
    In addition to the requirements for labeling the color additive or
color additive mixture, the ingredient list on fish feed, to which
paracoccus pigment is added, must identify the presence of the color
additive under Sec.  501.4 (21 CFR 501.4). New Sec.  73.352(d)(2)
references Sec.  501.4 to ensure that the presence of paracoccus
pigment as a color additive in the fish feed will be declared on the
ingredient label. Finally, the presence of the color additive must be
declared on the label of any food, including salmonid fish, containing
added paracoccus pigment and food containing such salmonid fish as an
ingredient. Section 101.22(b) (21 CFR 101.22(b)) requires a food that
bears or contains artificial coloring, such as salmon artificially
colored with paracoccus pigment, to bear labeling even though such food
is not in package form. Section 101.22(c) (21 CFR 101.22(c)) requires
that label statements of artificial coloring be ``likely to be read

by the ordinary person under customary conditions of purchase and use
of such food.''
    Furthermore, Sec.  101.22(k)(2) requires, in the statement of
ingredients for a food to which any coloring has been added, and for
which the coloring is not subject to certification, a declaration that
makes it clear that a color additive has been used in the food. In
addition, the presence of a color additive in a food received in a bulk
container that is held at a retail establishment must be declared on
the labeling of the bulk container or on a counter card or other
similar device under the provisions in Sec.  101.100(a)(2) (21 CFR
101.100(a)(2)). The ingredient label would alert the consumer that the
fish is artificially colored. Without such ingredient labeling, food
comprising salmonid fish with added paracoccus pigment would be deemed
to be misbranded under section 403(k) of the Federal Food, Drug, and
Cosmetic Act, which states that: A food shall be deemed to be
misbranded ``If it bears or contains any artificial flavoring,
artificial coloring, or chemical preservative, unless it bears labeling
stating that fact * * *.''
    Therefore, in accordance with Sec. Sec.  101.22(b), (c), and
(k)(2), and 101.100(a)(2), labeling on any salmonid fish containing
paracoccus pigment is required to declare the presence of the color
additive or color additive mixture. New Sec.  73.352(d)(3) references
Sec. Sec.  101.22(b), (c), and (k)(2), and 101.100(a)(2) to ensure
that, at the retail level, the presence of paracoccus pigment as a
color additive in the fish will be declared, and that the labeling of
the bulk fish container, including a list of ingredients, will be
displayed on the container or on a counter card with similar
information.

V. Conclusion

    FDA reviewed data in the petition and other available relevant
material to evaluate the safety of the use of paracoccus pigment as a
color additive in the feed of salmonid fish to enhance the color of
their flesh. Based on this information, the agency concludes that the
proposed use of the additive is safe, and the additive will achieve its
intended technical effect. Therefore, the regulations in part 73 should
be amended as set forth in this document. In addition, based upon the
factors listed in Sec.  71.20(b) (21 CFR 71.20(b)), the agency
concludes that certification of paracoccus pigment is not necessary for
the protection of the public health.

VI. Public Disclosure

    In accordance with Sec.  71.15 (21 CFR 71.15), the petition and the
documents that FDA considered and relied upon in reaching its decision
to approve the petition will be made available for inspection at the
Center for Food Safety and Applied Nutrition by appointment with the
information contact person (see FOR FURTHER INFORMATION CONTACT). As
provided in Sec.  71.15, the agency will delete from the documents any
materials that are not available for public disclosure before making
the documents available for inspection.

VII. Environmental Impact

    The agency has previously considered the environmental effects of
this rule as announced in the notice of filing for CAP 7C0283 (72 FR
37243). No new information or comments have been received that would
affect the agency's previous determination that there is no significant
impact on the human environment and that an environmental impact
statement is not required.

VIII. 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.

IX. Section 301(ll) of the Federal Food, Drug, and Cosmetic Act

    FDA's review of this petition was limited to section 721 of the act
(21 U.S.C. 379e). This final rule is not a statement regarding
compliance with other sections of the act. For example, the Food and
Drug Administration Amendments Act of 2007, which was signed into law
on September 27, 2007, amended the act to, among other things, add
section 301(ll). Section 301(ll) of the 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 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) through (4) applies. In our review
of this petition, FDA did not consider whether section 301(ll) or any
of its exemptions apply to food containing this additive. Accordingly,
this final rule should not be construed to be a statement that a food
containing this additive, if introduced or delivered for introduction
into interstate commerce, would not violate section 301(ll).
Furthermore, this language is now included in all color additive final
rules for food use and therefore should not be construed to be a
statement of the likelihood that section 301(ll) applies.

X. Objections

    This rule is effective as shown in the DATES section of this
document; except as to any provisions that may be stayed by the filing
of proper objections. Any person who will be adversely affected by this
regulation may file with the Division of Dockets Management (see
ADDRESSES) electronic or written objections. Each objection shall be
separately numbered, and each numbered objection shall specify with
particularity the provisions of the regulation to which objection is
made and the grounds for the objection. Each numbered objection on
which a hearing is requested shall specifically so state. Failure to
request a hearing for any particular objection shall constitute a
waiver of the right to a hearing on that objection. Each numbered
objection for which a hearing is requested shall include a detailed
description and analysis of the specific factual information intended
to be presented in support of the objection in the event that a hearing
is held. Failure to include such a description and analysis for any
particular objection shall constitute a waiver of the right to a
hearing on the objection. Three copies of all documents are to be
submitted and are to be identified with the 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. FDA will
publish notice of the objections that the agency has received or lack
thereof in the Federal Register.

List of Subjects in 21 CFR Part 73

    Color additives, Cosmetics, Drugs, Medical devices.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, and
redelegated to the 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 73.352 is added to subpart A to read as follows:

Sec.  73.352  Paracoccus pigment.

    (a) Identity. (1) The color additive paracoccus pigment consists of
the heat-killed, dried cells of a nonpathogenic and nontoxicogenic
strain of the bacterium Paracoccus carotinifaciens and may contain
added calcium carbonate to adjust the astaxanthin level.
    (2) Color additive mixtures for fish feed use made with paracoccus
pigment may contain only those diluents that are suitable and are
listed in this subpart as safe for use in color additive mixtures for
coloring foods.
    (b) Specifications. Paracoccus pigment shall conform to the
following specifications and shall be free from impurities, other than
those named, to the extent that such impurities may be avoided by good
manufacturing practice:
    (1) Physical state, solid.
    (2) Lead, not more than 5 milligrams per kilogram (mg/kg) (5 parts
per million (ppm)).
    (3) Arsenic, not more than 2 mg/kg (2 ppm).
    (4) Mercury, not more than 1 mg/kg (1 ppm).
    (5) Heavy metals (as Pb), not more than 10 mg/kg (10 ppm).
    (6) Astaxanthin, not less than 1.75 percent.
    (c) Uses and restrictions. Paracoccus pigment may be safely used in
the feed of salmonid fish in accordance with the following prescribed
conditions:
    (1) The color additive is used to enhance the pink to orange-red
color of the flesh of salmonid fish.
    (2) The quantity of astaxanthin in finished feed, from paracoccus
pigment when used alone or in combination with other astaxanthin color
additive sources listed in this part 73, shall not exceed 80 mg/kg (72
grams per ton) of finished feed.
    (d) Labeling requirements. (1) The labeling of the color additive
and any premixes prepared therefrom shall bear expiration dates for the
sealed and open container (established through generally accepted
stability testing methods), other information required by Sec.  70.25
of this chapter, and adequate directions to prepare a final product
complying with the limitations prescribed in paragraph (c) of this
section.
    (2) The presence of the color additive in finished fish feed
prepared according to paragraph (c) of this section shall be declared
in accordance with Sec.  501.4 of this chapter.
    (3) The presence of the color additive in salmonid fish that have
been fed feeds containing paracoccus pigment shall be declared in
accordance with Sec. Sec.  101.22(b), (c), and (k)(2), and
101.100(a)(2) 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 act.

    Dated: November 5, 2009.
Leslye M. Fraser,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. E9-27394 Filed 11-13-09; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 83, Number 206 (Wednesday, October 24, 2018)]
[Notices]
[Pages 53643-53644]
[FR Doc No: 2018-23166]

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

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

[Docket No. USCG-2018-0283]

Collection of Information Under Review by Office of Management
and Budget; OMB Control Number: 1625-0113

AGENCY: Coast Guard, DHS.

ACTION: Thirty-day notice requesting comments.

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

SUMMARY: In compliance with the Paperwork Reduction Act of 1995 the
U.S. Coast Guard is forwarding an Information Collection Request (ICR),
abstracted below, to the Office of Management and Budget (OMB), Office
of Information and Regulatory Affairs (OIRA), requesting approval for
reinstatement, without change, of the following collection of
information: 1625-0113, Crewmember Identification Documents. Our ICR
describes the information we seek to collect from the public. Review
and comments by OIRA ensure we only impose paperwork burdens
commensurate with our performance of duties.

DATES: Comments must reach the Coast Guard and OIRA on or before
November 23, 2018.

ADDRESSES: You may submit comments identified by Coast Guard docket
number [USCG-2018-0283] to the Coast Guard using the Federal
eRulemaking Portal at https://www.regulations.gov. Alternatively, you
may submit

comments to OIRA using one of the following means:
    (1) Email: [email protected].
    (2) Mail: OIRA, 725 17th Street NW, Washington, DC 20503, attention
Desk Officer for the Coast Guard.
    A copy of the ICR is available through the docket on the internet
at https://www.regulations.gov. Additionally, copies are available
from: Commandant (CG-612), Attn: Paperwork Reduction Act Manager, U.S.
Coast Guard, 2703 Martin Luther King Jr. Ave. SE, Stop 7710,
Washington, DC 20593-7710.

FOR FURTHER INFORMATION CONTACT: Mr. Anthony Smith, Office of
Information Management, telephone<PHONE_NUMBER>, or fax<PHONE_NUMBER>,
for questions on these documents.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    This Notice relies on the authority of the Paperwork Reduction Act
of 1995; 44 U.S.C. Chapter 35, as amended. An ICR is an application to
OIRA seeking the approval, extension, or renewal of a Coast Guard
collection of information (Collection). The ICR contains information
describing the Collection's purpose, the Collection's likely burden on
the affected public, an explanation of the necessity of the Collection,
and other important information describing the Collection. There is one
ICR for each Collection.
    The Coast Guard invites comments on whether this ICR should be
granted based on the Collection being necessary for the proper
performance of Departmental functions. In particular, the Coast Guard
would appreciate comments addressing: (1) The practical utility of the
Collection; (2) the accuracy of the estimated burden of the Collection;
(3) ways to enhance the quality, utility, and clarity of information
subject to the Collection; and (4) ways to minimize the burden of the
Collection on respondents, including the use of automated collection
techniques or other forms of information technology. These comments
will help OIRA determine whether to approve the ICR referred to in this
Notice.
    We encourage you to respond to this request by submitting comments
and related materials. Comments to Coast Guard or OIRA must contain the
OMB Control Number of the ICR. They must also contain the docket number
of this request, [USCG-2018-0283], and must be received by November 23,
2018.

Submitting Comments

    We encourage you to submit comments through the Federal eRulemaking
Portal at https://www.regulations.gov. If your material cannot be
submitted using https://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions. Documents mentioned in this notice, and all public
comments, are in our online docket at https://www.regulations.gov and
can be viewed by following that website's instructions. Additionally,
if you go to the online docket and sign up for email alerts, you will
be notified when comments are posted.
    We accept anonymous comments. All comments received will be posted
without change to https://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, you may review a Privacy Act notice regarding the Federal
Docket Management System in the March 24, 2005, issue of the Federal
Register (70 FR 15086).
    OIRA posts its decisions on ICRs online at https://www.reginfo.gov/public/do/PRAMain after the comment period for each ICR. An OMB Notice
of Action on each ICR will become available via a hyperlink in the OMB
Control Number: 1625-0113.

Previous Request for Comments

    This request provides a 30-day comment period required by OIRA. The
Coast Guard published the 60-day notice (83 FR 40305, August 14, 2018)
required by 44 U.S.C. 3506(c)(2). That Notice elicited no comments.
Accordingly, no changes have been made to the Collections.

Information Collection Request

    Title: Crewmember Identification Documents.
    OMB Control Number: 1625-0113.
    Summary: This information collection covers the requirement that
crewmembers on vessels calling at U.S. ports must carry and present on
demand an identification that allows the identity of crewmembers to be
authoritatively validated.
    Need: Title 46 U.S.C. 70111 mandated that the Coast Guard establish
regulation about crewmember identification. The regulations are in 33
CFR part 160 Subpart D.
    Forms: None.
    Respondents: Crewmembers, and operators of certain vessels.
    Frequency: On occasion.
    Hour Burden Estimate: The estimated burden has decreased from
34,293 hours to 32,955 hours a year due to a decrease in the estimated
time to acquire an acceptable identification document.

    Authority:  The Paperwork Reduction Act of 1995; 44 U.S.C.
Chapter 35, as amended.

    Dated: October 18, 2018.
James D. Roppel,
U.S. Coast Guard, Acting Chief, Office of Information Management.
[FR Doc. 2018-23166 Filed 10-23-18; 8:45 am]
 BILLING CODE 9110-04-P


[Federal Register Volume 81, Number 28 (Thursday, February 11, 2016)]
[Notices]
[Pages 7351-7352]
[FR Doc No: 2016-02786]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-N-0001]

Pharmacy Compounding Advisory Committee; Notice of Meeting

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: This notice announces a forthcoming meeting of a public
advisory committee of the Food and Drug Administration (FDA). The
meeting will be open to the public.
    Name of Committee: Pharmacy Compounding Advisory Committee (PCAC).
    General Function of the Committee: To provide advice on scientific,
technical, and medical issues concerning drug compounding under
sections 503A and 503B (21 U.S.C. 353A and 353B) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act), and, as required, any other product
for which FDA has regulatory responsibility, and make appropriate
recommendations to the Commissioner of Food and Drugs.
    Date and Time: The meeting will be held on March 8, 2016, from 8:30
a.m. to 4:30 p.m., and on March 9, 2016, from 8:30 a.m. to 1 p.m.
    Location: FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993-
0002. Answers to commonly asked questions including information
regarding special accommodations due to a disability, visitor parking,
and transportation may be accessed at: http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Cindy Hong, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 31, rm. 2417, Silver Spring, MD 20993-0002,<PHONE_NUMBER>, FAX:
301-847-8533, email<EMAIL_ADDRESS>or FDA Advisory Committee
Information Line, 1-800-741-8138<PHONE_NUMBER> in the Washington, DC
area). A notice in the Federal Register about last minute modifications
that impact a previously announced advisory committee meeting cannot
always be published quickly enough to provide timely notice. Therefore,
you should always check the Agency's Web site at http://www.fda.gov/AdvisoryCommittees/default.htm and scroll down to the appropriate
advisory committee meeting link, or call the advisory committee
information line to learn about possible modifications before coming to
the meeting.

SUPPLEMENTARY INFORMATION:
    Background: Section 503A of the FD&C Act describes the conditions
that must be satisfied for human drug products compounded by a licensed
pharmacist or licensed physician to be exempt from the following three
sections of the FD&C Act: (1) Section 501(a)(2)(B) (concerning current
good manufacturing practice (CGMP)); (2) section 502(f)(1) (concerning
the labeling of drugs with adequate directions for use); and (3)
section 505 (21 U.S.C. 355) (concerning the approval of human drug
products under new drug applications (NDAs) or abbreviated new drug
applications (ANDAs)).
    The Drug Quality and Security Act adds a new section, 503B, to the
FD&C Act that creates a new category of ``outsourcing facilities.''
Outsourcing facilities, as defined in section 503B of the FD&C Act, are
facilities that meet certain conditions described in section 503B,
including registration with FDA as an outsourcing facility. If these
conditions are satisfied, a drug product compounded for human use by or
under the direct supervision of a licensed pharmacist in an outsourcing
facility is exempt from three sections of the FD&C Act: (1) Section
502(f)(1), concerning the labeling of drugs with adequate directions
for use; (2) section 505, concerning the approval of human drug
products under NDAs or ANDAs; and (3) section 582, concerning the track
and trace requirements in the Drug Supply Chain Security Act (Pub. L.
113-53). Outsourcing facilities are not exempt from CGMP requirements
in section 501(a)(2)(B) of the FD&C Act.
    One of the conditions that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that a bulk drug
substance (active pharmaceutical ingredient) used in a compounded drug
product must meet one of the following criteria: (1) Complies with the
standards of an applicable United States Pharmacopoeia (USP) or
National Formulary monograph, if a monograph exists, and the USP
chapter on pharmacy compounding; (2) if an applicable monograph does
not exist, is a component of a drug approved by the Secretary of Health
and Human Services (the Secretary); or (3) if such a monograph does not
exist and the drug substance is not a component of a drug approved by
the Secretary, appears on a list (the ``section 503A bulk drug
substances list'') developed by the Secretary through regulations
issued by the Secretary (see section 503A(b)(1)(A)(i) of the FD&C Act).
    Another condition that must be satisfied to qualify for the
exemptions under section 503A of the FD&C Act is that the compounded
drug product is not a drug product identified by the Secretary by
regulation as a drug product that presents demonstrable difficulties
for compounding that reasonably demonstrate an adverse effect on the
safety or effectiveness of that drug product (see section 503A(b)(3)(A)
of the FD&C Act).
    A condition that must be satisfied to qualify for the exemptions in
section 503B of the FD&C Act is that the compounded drug is not
identified (directly or as part of a category of drugs) on a list
published by the Secretary, by regulation after consulting with the
Pharmacy Compounding Advisory Committee, of drugs or categories of
drugs that present demonstrable difficulties for compounding that are
reasonably likely

to lead to an adverse effect on the safety or effectiveness of the drug
or category of drugs, taking into account the risks and benefits to
patients, or the drug is compounded in accordance with all applicable
conditions identified on the list as conditions that are necessary to
prevent the drug or category of drugs from presenting such demonstrable
difficulties (see section 503B(a)(6)(A) and (B) of the FD&C Act).
    FDA will discuss with the committee drugs proposed for inclusion on
the section 503A bulk drug substances list and on the demonstrably
difficult to compound list under sections 503A and 503B of the FD&C
Act.
    Agenda: On March 8, 2016, the committee will discuss six bulk drug
substances nominated for inclusion on the section 503A bulk drug
substances list. FDA will discuss the following nominated bulk drug
substances: Quinacrine hydrochloride, boswellia, aloe vera 200:1 freeze
dried, D-ribose, chondroitin sulfate, and acetyl-L-carnitine. The
nominators of these substances will be invited to make a short
presentation supporting the nomination.
    On March 9, 2016, the committee will discuss two categories of drug
products nominated for the list of drug products that present
demonstrable difficulties for compounding. These categories of drug
products are metered dose inhalers and dry powder inhalers. The
nominators who nominated the category of drugs or specific drug
products in the category will be invited to make a short presentation
supporting the nomination.
    FDA intends to make background material available to the public no
later than 2 business days before the meeting. If FDA is unable to post
the background material on its Web site prior to the meeting, the
background material will be made publicly available at the location of
the advisory committee meeting, and the background material will be
posted on FDA's Web site after the meeting. Background material is
available at http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee meeting
link.
    Procedure: Interested persons may present data, information, or
views, orally or in writing, on issues pending before the committee.
Written submissions may be made to the contact person on or before
March 1, 2016. Oral presentations from the public will be scheduled
between approximately 11 a.m. to 11:15 a.m. and 3:15 p.m. to 3:30 p.m.
on March 8, 2016, and between approximately 11:30 a.m. to 12 noon on
March 9, 2016. Those individuals interested in making formal oral
presentations should notify the contact person and submit a brief
statement of the general nature of the evidence or arguments they wish
to present, the names and addresses of proposed participants, and an
indication of the approximate time requested to make their presentation
on or before February 24, 2016. Time allotted for each presentation may
be limited. If the number of registrants requesting to speak is greater
than can be reasonably accommodated during the scheduled open public
hearing session, FDA may conduct a lottery to determine the speakers
for the scheduled open public hearing session. The contact person will
notify interested persons regarding their request to speak by February
25, 2016.
    Persons attending FDA's advisory committee meetings are advised
that the Agency is not responsible for providing access to electrical
outlets.
    FDA welcomes the attendance of the public at its advisory committee
meetings and will make every effort to accommodate persons with
disabilities. If you require accommodations due to a disability, please
contact Cindy Hong at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our Web site at http://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm111462.htm for procedures
on public conduct during advisory committee meetings.
    Notice of this meeting is given under the Federal Advisory
Committee Act (5 U.S.C. app. 2).

    Dated: February 8, 2016.
Jill Hartzler Warner,
Associate Commissioner for Special Medical Programs.
[FR Doc. 2016-02786 Filed 2-8-16; 4:15 pm]
 BILLING CODE 4164-01-P


[Federal Register Volume 83, Number 23 (Friday, February 2, 2018)]
[Proposed Rules]
[Pages 4882-4884]
[FR Doc No: 2018-02114]

=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 110

[Docket Number USCG-2017-1125]
RIN 1625-AA01

Anchorage Grounds; Saint Lawrence Seaway, Cape Vincent, New York

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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

SUMMARY: The Coast Guard proposes to establish at the request of the
Saint Lawrence Seaway Development Corporation, two separate anchorage
grounds, Carleton Island Anchorage and Tibbetts Point Anchorage, near
Cape Vincent, New York. The Federal Anchorage Ground designations will
enable a pilot to disembark a safely anchored vessel which will help
reduce pilot fatigue, increase pilot availability, and reduce costs
incurred by vessels transiting the Seaway. We invite your comments on
this proposed rulemaking.

DATES: Comments and related material must be received by the Coast
Guard on or before May 3, 2018.

ADDRESSES: You may submit comments identified by docket number USCG-
2017-1125 using the Federal eRulemaking Portal at http://www.regulations.gov. See the ``Public Participation and Request for
Comments'' portion of the SUPPLEMENTARY INFORMATION section for further
instructions on submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions about this
proposed rulemaking, call or email Lieutenant Jason Radcliffe, Ninth
District, Waterways Operations, U.S. Coast Guard; telephone 216-902-
6060, email [email protected].

SUPPLEMENTARY INFORMATION:

I. Table of Abbreviations

CFR Code of Federal Regulations
DHS Department of Homeland Security
FR Federal Register
NPRM Notice of proposed rulemaking
Pub. L. Public Law
Sec.  Section
U.S.C. United States Code

II. Background, Purpose, and Legal Basis

    The Coast Guard proposes to establish two anchorage grounds one in
the vicinity of Carleton Island, New York and the second near Tibbetts
Point, New York. Each area has historically been used as an anchorage
and the Saint Lawrence Seaway Development Corporation, at the request
of its waterway users, has requested each area to be officially
designated as Federal Anchorage Grounds.
    Without this designation, pilots who anchor a ship in the
respective areas are unable to disembark during sustained delay periods
which hinder compliance with rest requirements and complicate pilot
availability and logistics for other vessels. The Coast Guard proposes
this rulemaking under authority in 33 U.S.C. 471, 1221 through 1236,
2071; 33 CFR 1.05-1; Department of Homeland Security Delegation No.
0170.1.

III. Discussion of Proposed Rule

    The Coast Guard is proposing to establish two new anchorage areas
to be known as Carleton Island Anchorage and Tibbetts Point Anchorage.
    The Carleton Island Anchorage would be located just northeast and
adjacent to Carleton Island and Millen Bay. The boundaries of Carleton
Island Anchorage are presented in the proposed regulatory text at the
end of this document. The anchorage would be approximately .75 square
miles. Proposed Carleton Island Anchorage is primarily intended for use
by up-bound inland or ocean going bulk freight and tank ships, towing
vessels and barges that need to anchor and wait for the availability of
a Lake Ontario Pilot. Under this proposed rule no anchors would be
allowed to be placed in the channel and no portion of the hull or
rigging would be allowed to extend outside the limits of the anchorage
area.
    The Tibbetts Point Anchorage would be located just west and
adjacent to Tibbetts Point and Fuller Bay. The boundaries of Tibbett's
Point Anchorage are presented in the proposed regulatory text at the
end of this document. The anchorage would be approximately 1.5 square
miles. Proposed Tibbett's Point Anchorage is primarily intended for use
by down-bound inland or ocean going bulk freight and tank ships, towing
vessels and barges that need to anchor and wait for the availability of
a River Pilot. Under this proposed rule no anchors would be allowed to
be placed in the channel and no portion of the hull or rigging would be
allowed to extend outside the limits of the anchorage area.
    Whenever the maritime or commercial interests of the United States
so require, the Saint Lawrence Seaway Development Corporation or their
designated representative may direct the movement of any vessel
anchored or moored within the anchorage area. The Coast Guard has
ascertained the view of the Buffalo, New York District and Division
Engineer, Corps of Engineers, U.S. Army, about the specific provisions
of this proposed rule.

IV. Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and Executive Orders related to rulemaking. Below we summarize our
analyses based on a number of these statutes and Executive orders and
we discuss First Amendment rights of protestors.

A. Regulatory Planning and Review

    Executive Orders 12866 and 13563 direct agencies to assess the
costs and benefits of available regulatory alternatives and, if
regulation is necessary, to select regulatory approaches that maximize
net benefits. Executive Order 13563 emphasizes the importance of
quantifying both costs and benefits, of reducing costs, of harmonizing
rules, and of promoting flexibility.
    Executive Order 13771 directs agencies to control regulatory costs
through a budgeting process. This NPRM has not been designated a
``significant regulatory action,'' under Executive Order 12866.
Accordingly, the NPRM has not been reviewed by the Office of Management
and Budget, and pursuant to OMB guidance it is exempt from the
requirements of Executive Order 13771.
    We conclude that this proposed rule is not a significant regulatory
action based on the location and size of the proposed anchorage
grounds, as well as the historical automatic identification system
(AIS) data. The impacts on routine navigation are expected to be
minimal because the proposed anchorage grounds are located outside the
navigational channel. When not occupied, vessels would be able to
maneuver in, around and through the anchorage.

B. Impact on Small Entities

    The Regulatory Flexibility Act of 1980, 5 U.S.C. 601-612, as
amended, requires Federal agencies to consider the potential impact of
regulations on small entities during rulemaking. The term ``small
entities'' comprises small

businesses, not-for-profit organizations that are independently owned
and operated and are not dominant in their fields, and governmental
jurisdictions with populations of less than 50,000. The Coast Guard
certifies under 5 U.S.C. 605(b) that this proposed rule would not have
a significant economic impact on a substantial number of small
entities.
    The number of small entities impacted and the extent of the impact,
if any, is expected to be minimal. The anchorage area is not routinely
transited by vessels heading to, or returning from, known fishing
grounds. It is also not used by small entities, including small
vessels, for anchoring due to the depth of water naturally present in
the area.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.
    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule. If the rule would affect
your small business, organization, or governmental jurisdiction and you
have questions concerning its provisions or options for compliance,
please contact the person listed in the FOR FURTHER INFORMATION CONTACT
section. The Coast Guard will not retaliate against small entities that
question or complain about this proposed rule or any policy or action
of the Coast Guard.

C. Collection of Information

    This proposed rule would not call for a new collection of
information under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-
3520).

D. Federalism and Indian Tribal Governments

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has 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. We have analyzed this proposed rule under that Order and
have determined that it is consistent with the fundamental federalism
principles and preemption requirements described in Executive Order
13132.
    Also, this proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes. If
you believe this proposed rule has implications for federalism or
Indian tribes, please contact the person listed in the FOR FURTHER
INFORMATION CONTACT section.

E. Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In particular, the Act addresses actions that may
result in the expenditure by a State, local, or tribal government, in
the aggregate, or by the private sector of $100,000,000 (adjusted for
inflation) or more in any one year. Though this proposed rule would not
result in such an expenditure, we do discuss the effects of this rule
elsewhere in this preamble.

F. Environment

    We have analyzed this proposed rule under Department of Homeland
Security Directive 023-01, which guides the Coast Guard in complying
with the National Environmental Policy Act of 1969 (42 U.S.C. 4321-
4370f), and have made a preliminary determination that this action is
one of a category of actions that do not individually or cumulatively
have a significant effect on the human environment. This proposed rule
involves the establishment of a permanent anchorage near Carleton
Island, New York. Normally such actions are categorically excluded from
further review under paragraph L59(a) of Appendix A, Table 1 of DHS
Instruction Manual 023-01-001-01, Rev. 01. A preliminary Record of
Environmental Consideration supporting this determination is available
in the docket where indicated under ADDRESSES. We seek any comments or
information that may lead to the discovery of a significant
environmental impact from this proposed rule.

G. Protest Activities

    The Coast Guard respects the First Amendment rights of protesters.
Protesters are asked to contact the person listed in the FOR FURTHER
INFORMATION CONTACT section to coordinate protest activities so that
your message can be received without jeopardizing the safety or
security of people, places, or vessels.

V. Public Participation and Request for Comments

    We view public participation as essential to effective rulemaking,
and will consider all comments and material received during the comment
period. Your comment can help shape the outcome of this rulemaking. If
you submit a comment, please include the docket number for this
rulemaking, indicate the specific section of this document to which
each comment applies, and provide a reason for each suggestion or
recommendation.
    We encourage you to submit comments through the Federal eRulemaking
Portal at http://www.regulations.gov. If your material cannot be
submitted using http://www.regulations.gov, contact the person in the
FOR FURTHER INFORMATION CONTACT section of this document for alternate
instructions.
    We accept anonymous comments. All comments received will be posted
without change to http://www.regulations.gov and will include any
personal information you have provided. For more about privacy and the
docket, visit http://www.regulations.gov/privacyNotice.
    Documents mentioned in this NPRM as being available in the docket,
and all public comments, will be in our online docket at http://www.regulations.gov and can be viewed by following that website's
instructions. Additionally, if you go to the online docket and sign up
for email alerts, you will be notified when comments are posted or a
final rule is published.
    We do not plan to hold a public meeting. You may submit a request
for a public meeting by contacting Lieutenant Radcliffe under the
ADDRESSES explaining why one would be beneficial. If we determine that
one would aid in this rulemaking, we will hold one at a time and place
announced by a later notice in the Federal Register.

List of Subjects in 33 CFR Part 110

    Anchorage grounds.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 110 as follows:

PART 110--ANCHORAGE REGULATIONS

0
1. The authority citation for part 110 continues to read as follows:

    Authority: 33 U.S.C. 471, 1221 through 1236, 2071; 33 CFR 1.05-
1; Department of Homeland Security Delegation No. 0170.1.

0
2. Add Sec.  110.209 to read as follows:

Sec.  110.209  Saint Lawrence Seaway Anchorages, NY.

    (a) Carleton Island Anchorage; Saint Lawrence River, Cape Vincent,
New York.
    (1) Carleton Island Anchorage Area. The waters bounded by a line
connecting the following, beginning at 44[deg]11'57.11'' N,
076[deg]14'04.62'' W; thence to 44[deg]11'21.80'' N, 076[deg]14'05.77''
W; thence to 44[deg]11'34.07'' N, 076[deg]15'49.57'' W;
44[deg]11'35.35'' N, 076[deg]16'47.50'' W; 44[deg]11'43.49'' N,
076[deg]16'48.00'' W; 44[deg]11'57.11'' N, 076[deg]14'04.62'' W and
back to the beginning point. These coordinates are based on WGS 84.
    (2) Tibbett's Island Anchorage Area. The waters bounded by a line
connecting the following points, beginning at 44[deg]05'20.27'' N,
076[deg]23'25''78[deg] W; thence to 44[deg]05'21.85'' N,
076[deg]22'40.97'' W; thence to 44[deg]04'34.08'' N, 076[deg]23'09.98''
W; 44[deg]04'07.72'' N; 076[deg]23'33.76'' W; 44[deg]04'32.78'' N,
076[deg]24'43.80'' W; 44[deg]05'44.37'' N, 076[deg]23'56.29'' W;
44[deg]05'20.27'' N, 076[deg]23' 25.78'' W and back to the beginning
point. These coordinates are based on WGS 84.
    (b) The Regulations. (1) Anchors must not be placed in the Saint
Lawrence Seaway shipping channel. No portion of the hull or rigging may
extend outside the limits of the anchorage area.
    (2) No vessel may occupy any general anchorage described in
paragraph (a) of this section for a period longer than 10 days unless
approval is obtained from the Captain of the Port for that purpose.
    (3) The COTP, or authorized representative, may require vessels to
depart from the Anchorages described above before the expiration of the
authorized or maximum stay. The COTP, or authorized representative,
will provide at least 12-hour notice to a vessel required to depart the
anchorages.

    Dated: January 11, 2018.
J.M. Nunan,
Rear Admiral, U.S. Coast Guard, Commander, Ninth Coast Guard District.
[FR Doc. 2018-02114 Filed 2-1-18; 8:45 am]
 BILLING CODE 9110-04-P