			  UNITED STATES OF AMERICA

		        DEPARTMENT OF TRANSPORTATION

			  OFFICE OF THE SECRETARY

			          WASHINGTON, D.C.

Issued by the Department of Transportation on July 1, 2004

NOTICE OF ACTION TAKEN -- DOCKET OST-2003-16771

________________________________________________________________________
________________________________________________________

This serves as notice to the public of the action described below, taken
by the Department official indicated (no additional confirming order
will be issued in this matter).

Applicant: Maersk Air A/S							Date Filed:  May 24, 2004

Relief requested:  Amend existing exemption and statement of
authorization to the extent necessary to permit Maersk Air A/S (Maersk)
to display the airline designator code of Continental Airlines, Inc.
(“CO”) on flights operated by Maersk between Brussels, Belgium, and
Billund, Denmark, for the carriage of Continental’s U.S.-Scandinavia
traffic.

If renewal, date and citation of last action:  Amends authority granted
April 5 and June 15, 2004, in this docket

Applicant representatives:  G. Paul Moates & Gabriel S. Meyer (202)
736--8000

Responsive pleadings:  None filed

DOT Analyst:  Shelita A. Smith—(202) 366-1226

DISPOSITION

Action:  Approved								Action date:  July 1, 2004

Effective dates of the exemption and statement of authorization granted:
 June 15, 2004 - April 5, 2006 (coextensive with the authority granted
Maersk on April 5, 2004, in this docket).

Basis for approval (bilateral agreement/reciprocity):  Air Transport
Agreements between the United States and Scandinavia (Denmark, Norway
and Sweden)

Except to the extent exempted/waived, this authority is subject to the
terms, conditions, and limitations indicated:

X  Standard exemption conditions (attached)

 X  Statement of authorization granted April 5, 2004, in this docket.

Special conditions/Partial grant/Denial basis/Remarks:

Action taken by:  Paul L. Gretch, Director

		   Office of International Aviation

________________________________________________________________________
________________________________________________________

Under authority assigned by the Department in its regulations, 14 CFR
Part 385, we found that (1) the applicant is qualified to perform the
proposed operations; (2) our action was consistent with Department
policy; (3) grant of the authority was consistent with the public
interest; and (4) grant of the authority would not constitute a major
regulatory action under the Energy Policy and Conservation Act of 1975.
To the extent not granted/deferred/dismissed, we denied

all requests in the referenced Docket.  We may amend, modify, or revoke
the authority granted in this Notice at any time without hearing at our
discretion.

Persons entitled to petition the Department for review of the action set
forth in this Notice under the Department’s regulations, 14 CFR §
385.30, may file their petitions within seven (7) days after the date of
issuance of this Notice.  This action was effective when taken, and the
filing of a petition for review will not alter such effectiveness.

An electronic version of this document is available on the World Wide
Web at:

  HYPERLINK "http://dms.dot.gov//reports/reports_aviation.asp"
http://dms.dot.gov//reports/reports_aviation.asp

Foreign Carrier Exemption Conditions

In the conduct of the operations authorized, the foreign carrier
applicant(s) shall:

(1)  Not conduct any operations unless it holds a currently effective
authorization from its homeland for such operations, and it has filed a
copy of such authorization with the Department;

(2)  Comply with all applicable requirements of the Federal Aviation
Administration, including, but not limited to, 14 CFR Parts 129, 91, and
36, and with all applicable U.S. Government requirements concerning
security, including, but not limited to, 49 CFR Part 1546 or 1550, as
applicable.  To assure compliance with all applicable U.S. Government
requirements concerning security, the holder shall, before commencing
any new service (including charter flights) from a foreign airport that
would be the holder’s last point of departure for the United States,
contact its International Principal Security Inspector (IPSI) to advise
the IPSI of its plans and to find out whether the Transportation
Security Administration has determined that security is adequate to
allow such airport(s) to be served;

(3)  Comply with the requirements for minimum insurance coverage
contained in 14 CFR Part 205, and, prior to the commencement of any
operations under this authority, file evidence of such coverage, in the
form of a completed OST Form 6411, with the Federal Aviation
Administration’s Program Management Branch (AFS-260), Flight Standards
Service (any changes to, or termination of, insurance also shall be
filed with that office);

(4)  Not operate aircraft under this authority unless it complies with
operational safety requirements at least equivalent to Annex 6 of the
Chicago Convention;

(5)  Conform to the airworthiness and airman competency requirements of
its Government for international air services;

(6)  Except as specifically exempted or otherwise provided for in a
Department Order, comply with the requirements of 14 CFR Part 203,
concerning waiver of Warsaw Convention liability limits and defenses;

(7)  Agree that operations under this authority constitute a waiver of
sovereign immunity, for the purposes of 28 U.S.C. 1605(a), but only with
respect to those actions or proceedings instituted against it in any
court or other tribunal in the United States that are: (a)  based on its
operations in international air transportation that, according to the
contract of carriage, include a point in the United States as a point of
origin, point of destination, or agreed stopping place, or for which the
contract of carriage was purchased in the United States; or (b)  based
on a claim under any international agreement or treaty cognizable in any
court or other tribunal of the United States.  In this condition, the
term "international air transportation" means "international
transportation" as defined by the Warsaw Convention, except that all
States shall be considered to be High Contracting Parties for the
purpose of this definition;

(8)  Except as specifically authorized by the Department, originate or
terminate all flights to/from the United States in its homeland;

(9)  Comply with the requirements of 14 CFR Part 217, concerning the
reporting of scheduled, nonscheduled, and charter data;

(10) If charter operations are authorized, except as otherwise provided
in the applicable aviation agreement, comply with the Department's rules
governing charters (including 14 CFR Parts 212 and 380); and

(11) Comply with such other reasonable terms, conditions, and
limitations required by the public interest as may be prescribed by the
Department, with all applicable orders or regulations of other U.S.
agencies and courts, and with all applicable laws of the United States.

This authority shall not be effective during any period when the holder
is not in compliance with the conditions imposed above.  Moreover, this
authority cannot be sold or otherwise transferred without explicit
Department approval under Title 49 of the U.S. Code.


[Federal Register Volume 78, Number 178 (Friday, September 13, 2013)]
[Notices]
[Pages 56742-56743]
[FR Doc No: 2013-22242]

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DEPARTMENT OF LABOR

Occupational Safety and Health Administration

[Docket No. OSHA-2013-0021]

Revision of Approved Information Collection (Paperwork)
Requirements for Office of Management and Budget (OMB) Approval; Cranes
and Derricks in Construction

AGENCY: Occupational Safety and Health Administration (OSHA), Labor.

ACTION: Request for public comments.

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SUMMARY: OSHA solicits public comments concerning its proposal to
revise OMB's approval of the information collection requirements
contained in the Cranes and Derricks in Construction Standard (29 CFR
part 1926, Subpart CC). Employers and workers use these requirements to
help ensure the safe operation of equipment covered by the standard. In
addition, OSHA compliance safety and health officers use the
information to determine, during an inspection, whether employers are
complying with the requirements. In May 2013, OSHA published a final
rule that broadened the exemption for digger derricks in the Cranes and
Derricks Standard in Construction Subpart CC. As a result, OSHA is
revising the Cranes and Derricks Standard in Construction paperwork
analysis by reducing the number of entities that are required to comply
with these information collection requirements.

DATES: Comments must be submitted (postmarked, sent, or received) by
November 12, 2013.

ADDRESSES:
    Electronically: You may submit comments and attachments
electronically at http://www.regulations.gov, which is the Federal
eRulemaking Portal. Follow the instructions online for submitting
comments.
    Facsimile: If your comments, including attachments, are not longer
than 10 pages you may fax them to the OSHA Docket Office at (202) 693-
1648.
    Mail, hand delivery, express mail, messenger, or courier service:
When using this method, you must submit a copy of your comments and
attachments to the OSHA Docket Office, Docket No. OSHA-2013-0021, U.S.
Department of Labor, Occupational Safety and Health Administration,
Room N-2625, 200 Constitution Avenue NW., Washington, DC 20210.
Deliveries (hand, express mail, messenger, and courier service) are
accepted during the Department of Labor's and Docket Office's normal
business hours, 8:15 a.m. to 4:45 p.m., e.t.
    Instructions: All submissions must include the Agency name and OSHA
docket number for the Information Collection Request (ICR) (OSHA-2013-
0021). All comments, including any personal information you provide,
are placed in the public docket without change, and may be made
available online at http://www.regulations.gov. For further information
on submitting comments see the ``Public Participation'' heading in the
section of this notice titled SUPPLEMENTARY INFORMATION.
    Docket: To read or download comments or other material in the
docket, go to http://www.regulations.gov or the OSHA Docket Office at
the address above. All documents in the docket (including this Federal
Register notice) are listed in the http://www.regulations.gov index;
however, some information (e.g., copyrighted material) is not publicly
available to read or download through the Web site. All submissions,
including copyrighted material, are available for inspection and
copying at the OSHA Docket Office. You may also contact Theda Kenney at
the address below to obtain a copy of the ICR.

FOR FURTHER INFORMATION CONTACT: Todd Owen or Theda Kenney, Directorate
of Standards and Guidance, OSHA, U.S. Department of Labor, Room N-3609,
200 Constitution Avenue NW., Washington, DC 20210; telephone (202) 693-
2222.

SUPPLEMENTARY INFORMATION:

I. Background

    The Department of Labor, as part of its continuing effort to reduce
paperwork and respondent (i.e., employer) burden, conducts a
preclearance consultation program to provide the public with an
opportunity to comment on proposed and continuing information
collection requirements in accord with the Paperwork Reduction Act of
1995 (PRA-95) (44 U.S.C. 3506(c)(2)(A)). This program ensures that
information is in the desired format, reporting burden (time and costs)
is minimal, collection instruments are clearly understood, and OSHA's
estimate of the information collection burden is accurate. The
Occupational Safety and Health Act of 1970 (the OSH Act) (29 U.S.C. 651
et seq.) authorizes information collection by employers as necessary or
appropriate for enforcement of the OSH Act or for developing
information regarding the causes and prevention of occupational
injuries, illnesses, and accidents (29 U.S.C. 657). The OSH Act also
requires that OSHA obtain such information with minimum burden upon
employers, especially those operating small businesses, and to reduce
to the maximum extent feasible unnecessary duplication of efforts in
obtaining information (29 U.S.C. 657).
    The Cranes and Derricks standard's information collection
requirements impose a duty on employers to produce and maintain records
that implement controls and take other measures to protect workers from
hazards related to cranes and derricks used in construction.
Accordingly, construction businesses with workers who operate or work
in the vicinity of cranes and derricks must have, as applicable, the
following documents on file and available at the job site: Equipment
ratings, employee training records, written authorizations from
qualified individuals, and qualification program audits. During an
inspection, OSHA will have access to the records to determine
compliance under conditions specified by the standard. An employer's
failure to generate and disclose the information required in this
standard will affect significantly the Agency's effort to control and
reduce injuries and fatalities related to the use of cranes and
derricks in construction.
    On May 29, 2013, OSHA published a final rule expanding the existing
digger-derrick exemption to include all digger derricks used in
construction work subject to 29 CFR part 1926 subpart V. OSHA revised
the exemption in existing 29 CFR 1926.1400(c)(4) to include within the
exemption the phrase ``any

other work subject to subpart V of 29 CFR part 1926'' (78 FR 32110).
Section II. D, Paperwork Reduction Act, of the final rule, stated:

    This rule, which expands the digger-derrick exemption, does not
require any additional collection of information or alter the
substantive requirements detailed in the 2010 ICR. The only impact
on the collection of information will be a reduction in the number
of entities collecting information. OMB did not require OSHA to
submit a new proposed ICR when OSHA issued the proposed rule, and
OSHA does not believe it is necessary to submit a new ICR to OMB
now. OSHA will identify any reduction in burden hours when it renews
the ICR. OSHA requested comment on this approach in the proposed
rulemaking describing the digger-derrick exemption, but received
none.

OSHA has revised the ICR to exempt digger derricks used in construction
work subject to 29 CFR part 1926 subpart V.

II. Special Issues for Comment

    OSHA has a particular interest in comments on the following issues:
     Whether the proposed information collection requirements
are necessary for the proper performance of the Agency's functions,
including whether the information is useful;
     The accuracy of OSHA's estimate of the burden (time and
costs) of the information collection requirements, including the
validity of the methodology and assumptions used;
     The quality, utility, and clarity of the information
collected; and
     Ways to minimize the burden on employers who must comply;
for example, by using automated or other technological information
collection and transmission techniques.

III. Proposed Actions

    As a result of expanding the digger-derrick exemption to include
all digger derricks used in construction work subject to 29 CFR part
1926 subpart V, OSHA is requesting a program change decrease of 35,715
hours, from 403,413 hours to 367,698 hours.
    OSHA will summarize the comments submitted in response to this
notice, and will include this summary in its request to OMB to extend
the approval of the information collection requirements contained in
the Cranes and Derricks Standard.
    Type of Review: Revision of a currently approved collection.
    Title: Cranes and Derricks in Construction (29 CFR part 1926
Subpart CC).
    OMB Control Number: 1218-0261.
    Affected Public: Business or other for-profits.
    Number of Respondents: 209,851.
    Total Responses: 2,558,718.
    Frequency of Responses: On occasion.
    Average Time per Response: Varies from 30 seconds (communicate
employee's location to operator) to 1.5 hours (develop and document
written assembly and disassembly procedures).
    Estimated Total Burden Hours: 367,698 hours.
    Estimated Cost (Operation and Maintenance): $2,029,130.

IV. Public Participation--Submission of Comments on This Notice and
Internet Access to Comments and Submissions

    You may submit comments in response to this document as follows:
(1) electronically at http://www.regulations.gov, which is the Federal
e-Rulemaking Portal; (2) by facsimile (fax); or (3) by hard copy. All
comments, attachments, and other materials must clearly identify the
Agency name and the OSHA docket number for the ICR (Docket No. OSHA-
2013-0021). You may supplement electronic submissions by uploading
document files electronically. If you wish to mail additional materials
in reference to an electronic or facsimile submission, you must submit
them to the OSHA Docket Office (see the section of this notice titled
ADDRESSES). The additional materials must clearly identify your
electronic comments by your name, date, and the docket number so the
Agency can attach them to your comments.
    Because of security procedures, the use of regular mail may cause a
significant delay in the receipt of comments. For information about
security procedures concerning the delivery of materials by hand,
express delivery, messenger, or courier service, please contact the
OSHA Docket Office at<PHONE_NUMBER>, (TTY<PHONE_NUMBER>).
    Comments and submissions are posted without change at http://www.regulations.gov. Therefore, OSHA cautions commenters about
submitting personal information such as Social Security numbers and
dates of birth. Although all submissions are listed in the http://www.regulations.gov index, some information (e.g., copyrighted
material) is not publically available to read or download through this
Web site. All submissions, including copyrighted material, are
available for inspection and copying at the OSHA Docket Office.
Information on using the http://www.regulations.gov Web site to submit
comments and access the docket is available through the Web site's
``User Tips'' link. Contact the OSHA Docket Office for information
about materials not available through the Web site, and for assistance
in using the Internet to locate docket submissions.

V. Authority and Signature

    David Michaels, Ph.D., MPH, Assistant Secretary of Labor for
Occupational Safety and Health, directed the preparation of this
notice. The authority for this notice is the Paperwork Reduction Act of
1995 (44 U.S.C. 3506 et seq.) and Secretary of Labor's Order No. 1-2012
(77 FR 3912).

    Signed at Washington, DC, on September 6, 2013.
David Michaels,
Assistant Secretary of Labor for Occupational Safety and Health.
[FR Doc. 2013-22242 Filed 9-12-13; 8:45 am]
BILLING CODE 4510-26-P


[Federal Register Volume 85, Number 180 (Wednesday, September 16, 2020)]
[Notices]
[Pages 57867-57868]
[FR Doc No: 2020-20446]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-N-0008]

Circulatory System Devices Panel of the Medical Devices Advisory
Committee; Notice of Meeting

AGENCY: Food and Drug Administration, Health and Human Services (HHS).

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) announces a forthcoming
public advisory committee meeting of the Circulatory System Devices
Panel of the Medical Devices Advisory Committee. The general function
of the committee is to provide advice and recommendations to the Agency
on FDA's regulatory issues. The meeting will be open to the public.

DATES: The meeting will take place virtually on October 27, 2020, from
9 a.m. Eastern Time to 6 p.m. Eastern Time.

ADDRESSES: Please note that due to the impact of this COVID-19
pandemic, all meeting participants will be joining this advisory
committee meeting via an online teleconferencing platform. Answers to
commonly asked questions about FDA advisory committee meetings may be
accessed at: https://www.fda.gov/AdvisoryCommittees/AboutAdvisoryCommittees/ucm408555.htm.

FOR FURTHER INFORMATION CONTACT: Aden Asefa, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5214, Silver Spring, MD 20993-0002,<PHONE_NUMBER>,
<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 website at https://www.fda.gov/AdvisoryCommittees and scroll down to the appropriate advisory
committee meeting link, or call the advisory committee information line
to learn about possible modifications before the meeting.

SUPPLEMENTARY INFORMATION:
    Agenda: The meeting presentations will be heard, viewed, captioned,
and recorded through an online teleconferencing platform. On October
27, 2020, the committee will discuss, make recommendations, and vote on
information regarding the premarket approval application for the
Neovasc Reducer System sponsored by Neovasc, Inc. The proposed
Indication for Use of the Neovasc Reducer System is for patients
suffering from refractory angina pectoris despite guideline directed
medical therapy, who are unsuitable for revascularization by coronary
artery bypass grafting or by percutaneous coronary intervention.
    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 website prior to the meeting, the
background material will be made publicly available on FDA's website at
the time of the advisory committee meeting, and the background
materials will be posted on FDA's website after the meeting. Background
material and the link to the online teleconference meeting room will be
available at https://www.fda.gov/advisory-committees/medical-devices-advisory-committee/circulatory-system-devices-panel.
    Select the link for the 2020 Meeting Materials. The meeting will
include

slide presentations with audio components to allow the presentation of
materials in a manner that most closely resembles an in-person advisory
committee meeting.
    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
October 9, 2020. Oral presentations from the public will be scheduled
on October 27, 2020, between approximately 1 p.m. Eastern Time and 2
p.m. Eastern Time. Those individuals interested in making formal oral
presentations should notify the contact person (see FOR FURTHER
INFORMATION CONTACT). The notification should include 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 October 1, 2020. 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 October
2, 2020.
    For press inquiries, please contact the Office of Media Affairs at
<EMAIL_ADDRESS>or<PHONE_NUMBER>.
    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 AnnMarie Williams at<EMAIL_ADDRESS>or 301-796-
5966 at least 7 days in advance of the meeting.
    FDA is committed to the orderly conduct of its advisory committee
meetings. Please visit our website at https://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: September 11, 2020.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2020-20446 Filed 9-15-20; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register Volume 81, Number 137 (Monday, July 18, 2016)]
[Rules and Regulations]
[Pages 46578-46582]
[FR Doc No: 2016-16738]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 172

[Docket No. FDA-2013-N-0888]

Food Additives Permitted for Direct Addition to Food for Human
Consumption; Vitamin D2 and Vitamin D3

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
food additive regulations to expand the safe uses of vitamin
D2 as a nutrient supplement in edible plant-based beverages
intended for use as milk alternatives and in edible plant-based yogurt
alternatives and vitamin D3 as a nutrient supplement in milk
at levels higher than those currently permitted. We are taking this
action in response to a food additive petition filed by Dean Foods
Company and WhiteWave Foods Company.

DATES: This rule is effective July 18, 2016. See section VIII for
further information on the filing of objections. Submit either
electronic or written objections and requests for a hearing by August
17, 2016. The Director of the Federal Register approves the
incorporation by reference of certain publications listed in the rule
as of July 18, 2016.

ADDRESSES: You may submit objections and requests for a hearing as
follows:

Electronic Submissions

    Submit electronic objections in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Objections submitted
electronically, including attachments, to http://www.regulations.gov
will be posted to the docket unchanged. Because your objection will be
made public, you are solely responsible for ensuring that your
objection does not include any confidential information that you or a
third party may not wish to be posted, such as medical information,
your or anyone else's Social Security number, or confidential business
information, such as a manufacturing process. Please note that if you
include your name, contact information, or other information that
identifies you in the body of your objection, that information will be
posted on http://www.regulations.gov.
     If you want to submit an objection with confidential
information that you do not wish to be made available to the public,
submit the objection as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper objections submitted to the Division of
Dockets Management, FDA will post your objection, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2013-N-0888 for ``Food Additives Permitted for Direct Addition to
Food for Human Consumption; Vitamin D2 and Vitamin
D3 Final Rule.'' Received objections will be placed in the
docket and, except for those submitted as ``Confidential Submissions,''
publicly viewable at http://www.regulations.gov or at the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit an objection with
confidential information that you do not wish to be made publicly
available, submit your objections only as a written/paper submission.
You should submit two copies total. One copy will include the
information you claim to be confidential with a heading or cover note
that states ``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The
Agency will review this copy, including the claimed confidential
information, in its consideration of comments. The second copy, which
will have the claimed confidential information redacted/blacked out,
will be available for public viewing and posted on http://www.regulations.gov. Submit both copies to the Division of Dockets
Management. If you do not wish your name and contact information to be
made publicly available, you can provide this information on the cover
sheet and not in the body of your comments and you must identify this
information as ``confidential.'' Any information marked as
``confidential'' will not be disclosed except in accordance with 21 CFR
10.20 and other applicable disclosure law. For more information about
FDA's posting of comments to public dockets, see 80 FR 56469, September
18, 2015, or access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments 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: Judith Kidwell, Center for Food Safety
and Applied Nutrition (CFSAN) (HFS-265), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740-3835,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    In a document published in the Federal Register of August 16, 2013
(78 FR 49990), FDA announced that Dean Foods Company (Dean Foods) and
WhiteWave Foods Company (WhiteWave), c/o Hogan Lovells US LLP, Columbia
Square, 555 13th Street NW., Washington, DC 20004, had jointly filed a
food additive petition (FAP 3A4801). The petition proposed to amend 21
CFR 172.379 to provide for the safe use of vitamin D2 as a
nutrient supplement in edible plant-based food products intended for
use as alternatives to milk and milk products and to amend 21 CFR
172.380 to provide for the safe use of vitamin D3 as a
nutrient supplement in milk at levels higher than those currently
permitted. After the notice of filing published, the petitioners
amended the petition to limit the proposed use of vitamin D2
to only edible plant-based beverages intended as alternatives to milk
(e.g., soy-, rice-, almond-, coconut-based beverages) and edible plant-
based yogurt alternatives. This final rule is a complete response to
the petition.
    Dean Foods/WhiteWave have requested that we amend Sec.  172.379 to
authorize the use of vitamin D2 as a nutrient supplement at
levels not to exceed 84 International Units (IU) per 100 grams (g) in
edible plant-based beverages intended for use as milk alternatives and
not to exceed 89 IU per 100 g in edible plant-based yogurt
alternatives. Dean Foods/WhiteWave requested that the proposed use of
84 IU vitamin D2 per 100 g in edible plant-based beverages
replace the current allowable maximum use of 50 IU per 100 g in soy
beverages authorized under

Sec.  172.379(c). Specifically, Dean Foods/WhiteWave requested that we
amend Sec.  172.379(c) to eliminate the ``soy beverages'' category, and
instead create a new category of food that may be supplemented with
vitamin D2. This category, ``edible plant-based beverages
intended for use as milk alternatives'', would include soy beverages
intended as milk alternatives, and would have a maximum allowable use
of 84 IU vitamin D2 per 100 g. This category would also
include other edible plant-based beverages made from rice, almond, and
coconut, among other foods, that are intended as milk alternatives.
Dean Foods/WhiteWave also requested that we amend Sec.  172.380 to
allow for the addition of vitamin D3 as a nutrient
supplement in milk at levels not to exceed 84 IU per 100 g milk. For
milk with more than the amount of vitamin D provided for in the milk
standard of identity in 21 CFR 131.110(b)(2), the milk would be
required to be named by use of a nutrient content claim and a
standardized term in accordance with 21 CFR 130.10.
    Vitamin D comprises a group of fat-soluble seco-sterols and comes
in many forms. The two major physiologically relevant forms are vitamin
D2 and vitamin D3. Vitamin D without a subscript
represents either vitamin D2 or vitamin D3 or
both. Vitamin D is affirmed as generally recognized as safe (GRAS) for
use in food as a nutrient supplement in accordance with 21 CFR
184.1950(c)(1) and 21 CFR 184.1(b)(2), with the following specific
limitations:

------------------------------------------------------------------------
                                            Maximum  levels in food  (as
             Category of food                          served)
------------------------------------------------------------------------
Breakfast cereals.........................  350 IU/100 grams (g).
Grain products and pasta..................  90 IU/100 g.
Milk......................................  42 IU/100 g.
Milk products.............................  89 IU/100 g.
------------------------------------------------------------------------

    Additionally, under Sec.  184.1950(c)(2) and (3), vitamin D is
affirmed as GRAS for use in infant formulas and margarine,
respectively. Under Sec.  172.380, vitamin D3 is approved
for use as a food additive as a nutrient supplement in calcium-
fortified fruit juices and fruit juice drinks, meal replacement and
other type bars, soy protein-based meal replacement beverages
represented for special dietary use in reducing or maintaining body
weight, certain cheese and cheese products, meal replacement beverages
that are not intended for special dietary use in reducing or
maintaining body weight, and foods represented for use as a sole source
of nutrition for enteral feeding.
    Under Sec.  172.379, vitamin D2 is approved for use as a
food additive as a nutrient supplement in soy beverages, soy beverage
products, soy-based butter substitute spreads, and soy-based cheese
substitutes, and soy-based cheese substitute products.
    Under Sec.  172.381, vitamin D2 bakers yeast is approved
for use as a food additive as a source of vitamin D2 and as
a leavening agent in yeast-leavened baked goods and baking mixes and
yeast-leavened baked snack foods.
    Vitamin D is essential for human health. The major function of
vitamin D is the maintenance of blood serum concentrations of calcium
and phosphorus by enhancing the absorption of these minerals in the
small intestine. Vitamin D deficiency can lead to abnormalities in
calcium and bone metabolism, such as rickets in children or
osteomalacia in adults. Excessive intake of vitamin D elevates blood
plasma calcium levels (hypercalcemia) by increased intestinal
absorption and/or mobilization from the bone.
    To ensure that vitamin D is not added to the U.S. food supply at
levels that could raise safety concerns, FDA affirmed vitamin D as GRAS
with specific limitations as listed in Sec.  184.1950. Under Sec.
184.1(b)(2), an ingredient affirmed as GRAS with specific limitations
may be used in food only within such limitations, including the
category of food, functional use of the ingredient, and level of use.
Any addition of vitamin D to food beyond those limitations set out in
Sec.  184.1950 requires either a food additive regulation or an
amendment of Sec.  184.1950.
    To support their petition, Dean Foods/WhiteWave submitted dietary
exposure estimates of vitamin D from the proposed uses of vitamin
D2 and vitamin D3, as well as all dietary sources
from naturally occurring sources of vitamin D and uses in accordance
with our approved food additive regulations (Sec. Sec.  172.379,
172.380, and 172.381) and our GRAS affirmation regulation (Sec.
184.1950). They also included dietary supplements in their estimates
and compared these intake estimates to the Tolerable Upper Intake Level
(UL) for vitamin D established by the Institute of Medicine (IOM) of
the National Academies. Dean Foods/WhiteWave also submitted a number of
publications pertaining to human clinical studies on vitamin D. Based
on this information, Dean Foods/WhiteWave concluded that the proposed
uses of vitamin D2 in edible plant-based beverages intended
as alternatives to milk, edible plant-based yogurt alternatives, and
vitamin D3 in milk are safe.

II. Evaluation of Safety

    To establish with reasonable certainty that a food additive 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 the 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 and on data regarding the amount consumed from all food sources
of the additive. We commonly use the EDI for the 90th percentile
consumer of a food additive as a measure of high chronic dietary
intake.

A. Acceptable Daily Intake Level for Vitamin D

    In 2011, the Standing Committee on the Scientific Evaluation of
Dietary Reference Intakes of the Food and Nutrition Board at the IOM
conducted an extensive review of relevant published scientific
literature on vitamin D to update current dietary reference intakes and
ULs for vitamin D. Based on this information, the IOM revised the ULs
for vitamin D and developed a report on their findings (Ref. 1). In
their 2011 assessment of vitamin D, the IOM established a UL of 1,000
IU per day (IU/p/d) for infants 0 months to 6 months of age and a UL of
1,500 IU/p/d for infants 6 months to 12 months of age. For children 1
year to 3 years of age, the IOM established a UL of 2,500 IU/p/d; for
children 4 years to 8 years of age, the IOM established a UL of 3,000
IU/p/d. For children 9 years to 18 years of age and adults, the IOM
established a UL of 4,000 IU/p/d.
    The IOM considers the UL as the highest average daily intake level
of a nutrient that poses no risk of adverse effects when the nutrient
is consumed over long periods of time. The UL is determined using a
risk assessment model developed specifically for nutrients. The dose-
response assessment, which concludes with an estimate of the UL, is
built upon three toxicological concepts commonly used in assessing the
risk of exposures to chemical substances: No-observed-adverse-effect
level, lowest-observed-effect level, and application of an uncertainty
factor. We considered the ULs established by the IOM relative to

the intake estimates as the primary basis for assessing the safety of
the petitioned uses of vitamin D2 and vitamin D3.
We also reviewed scientific articles on the safety of vitamin D
submitted in the petition, as well as other relevant published studies
available to FDA.

B. Estimated Daily Intake for Vitamin D

    For the proposed uses of vitamin D2 and vitamin
D3, Dean Foods/WhiteWave provided dietary intake estimates
of vitamin D for 11 population groups, assuming maximum levels of
vitamin D in all foods that could be fortified (except for one scenario
where typical fortification levels in infant formula were used), as
well as in the petitioned foods. They also included exposure from
dietary supplements as reported in the 2003-2008 National Health and
Nutrition Survey (NHANES) 30-day dietary supplement use data (http://wwwn.cdc.gov/nchs/nhanes/search/datapage.aspx?Component=dietary) and
from naturally occurring food sources.
    The exposure estimates performed by Dean Foods/WhiteWave are
appropriate. However, there are some exposure parameters that have
changed since the estimates were completed in 2013. In particular, Dean
Foods/WhiteWave provided estimates that included vitamin D exposure
from fortification of edible plant-based dairy analogs other than
edible plant-based yogurt alternatives, which they are no longer
seeking to fortify. Dean Food/WhiteWave also included fortification of
meal replacement bars at a level of 500 IU/40 g in anticipation of the
approval of FAP 2A4788 (Abbott Laboratories); however, this use was
subsequently withdrawn from the petition before the final rule issued
(see 79 FR 46993, August 12, 2014). In addition, more recent 24-hour
recall dietary supplement data from the 2009-2012 NHANES (http://wwwn.cdc.gov/nchs/nhanes/search/datapage.aspx?Component=dietary) have
become available that may better represent current vitamin D exposure
from dietary supplements than the 30-day dietary supplement use data
from the 2003-2008 NHANES used by Dean Foods/WhiteWave. Moreover, a
recent published study suggests that it may be appropriate to include
dietary sources of the vitamin D metabolite, 25-hydroxyvitamin D
(25(OH)D), in vitamin D exposure estimates to take into account
discrepancies seen between dietary intake and blood serum levels of
vitamin D (Ref. 2). The foods that were identified in the study as
sources of 25(OH)D were beef, pork, chicken, turkey, and eggs. The
study also indicated that 25(OH)D may have a potency five times that of
vitamin D. For these reasons, we have used the 2009-2012 NHANES data to
estimate dietary exposure to vitamin D from: (1) The petitioned uses in
milk, edible plant-based beverages intended as milk alternatives, and
edible plant-based yogurt alternatives; and (2) cumulative exposure
from all current sources of vitamin D (i.e., naturally occurring
sources, approved fortified sources, and dietary supplements), the
petitioned uses of vitamin D in milk, edible plant-based beverages
intended as milk alternatives, and edible plant-based yogurt, and
exposure from sources of 25(OH)D, which have been adjusted to account
for the difference in potency between 25(OH)D and vitamin D.
    For the overall U.S. population 1 year of age and older, the
cumulative exposure at the 90th percentile from all food sources of
vitamin D, including the proposed uses, dietary supplements, and
25(OH)D, was estimated to be 2,000 IU/p/d. The cumulative exposure for
infants 0 to 6 months of age and infants 6 to 12 months of age from all
food sources of vitamin D, including the proposed uses, dietary
supplements, and 25(OH)D, was estimated to be 948 IU/p/d and 988 IU/p/
d, respectively, for the 90th percentile consumer (Ref. 3).

C. Safety of the Petitioned Uses of Vitamin D2

    We reviewed and evaluated the information submitted by Dean Foods/
WhiteWave regarding the safety of the dietary intake of vitamin D from
the proposed uses in milk, edible plant-based beverages intended as
milk alternatives, and edible plant-based yogurt alternatives. Dean
Food/WhiteWave submitted reports of scientific studies published
subsequent to the 1997 IOM report and issuance of the final rule (79 FR
46993) authorizing the use of vitamin D3 in meal replacement
beverages that are not intended for special dietary use in reducing or
maintaining body weight and in foods represented for use as a sole
source of nutrition for enteral feeding. Dean Food/WhiteWave concluded
that these publications support a conclusion that the proposed use of
vitamin D is safe.
    We reviewed the published reports of scientific studies on vitamin
D submitted by Dean Food/WhiteWave, as well as other relevant published
studies available to us since our previous evaluations of six food
additive petitions for fortifying a variety of foods with vitamin D (77
FR 52228, August 29, 2012; 74 FR 11019, March 16, 2009; 70 FR 69435,
November 16, 2005; 70 FR 37255, June 29, 2005; 70 FR 36021, June 22,
2005; 68 FR 9000, February 27, 2003). These studies did not raise any
new safety concerns regarding the current or proposed uses of vitamin
D. The most recent food additive petition resulted in our amendment of
the food additive regulations in Sec.  172.380 to allow for the safe
use of vitamin D3 in meal replacement beverages that are not
intended for special dietary use in reducing or maintaining body weight
and in foods represented for use as a sole source of nutrition for
enteral feeding (79 FR 46993). The six earlier food additive petitions
also resulted in amendments of the food additive regulations to allow
for the safe use of vitamin D as a nutrient supplement in certain
foods.
    We considered the ULs established by the IOM relative to the intake
estimates as the primary basis for assessing the safety of the
petitioned uses of vitamin D. Depending on the age group, the IOM UL
for vitamin D for the U.S. population 1 year of age and older ranges
from 2,500 IU/p/d to 4,000 IU/p/d. The estimated dietary exposure to
vitamin D from all food sources, including the proposed uses, at the
90th percentile for the U.S. population (1 years of age and older) is
estimated to be 2,000 IU/p/d, which is below the lowest IOM UL of 2,500
IU/p/d in the range of ULs for the overall U.S. population (1 year of
age and older). Estimated exposure to vitamin D from all food sources,
including the proposed uses, for infants 0 months to 6 months of age at
the 90th percentile is 948 IU/p/d; for infants 6 months to 12 months of
age, estimated exposure to vitamin D is 988 IU/p/d. Both of these
estimates are below the IOM UL of 1,000 IU/p/d for infants 0 months to
6 months of age and 1,500 IU/p/d for infants 6 months to 12 months of
age. Because the 90th percentile EDI of vitamin D from all current and
proposed food sources for each population group is less than the
corresponding IOM UL for that population group, we conclude that
dietary intake of vitamin D2 from the proposed use as a
nutrient supplement in edible plant-based beverages intended as milk
alternatives and edible plant-based yogurt alternatives and the
proposed increased maximum permitted level of vitamin D3 in
milk are safe (Ref. 4).

III. Incorporation by Reference

    FDA is incorporating by reference two monographs from the Food
Chemicals Codex 9th Edition (FCC 9), which was approved by the Office
of the Federal Register. You may purchase a copy of the material from
the United States Pharmacopeial Convention, 12601

Twinbrook Pkwy., Rockville, MD 20852, 1-800-227-8772, http://www.usp.org/.
    The current regulation for the use of vitamin D3 in food
(Sec.  172.380) indicates that the additive must meet the
specifications in the FCC 8. The more current FCC is the 9th Edition.
The current regulation for vitamin D2 (Sec.  172.379)
indicates the additive must meet the specifications in the 7th edition
of the FCC (FCC 7). Because the specifications for vitamin
D2 and vitamin D3 in FCC 9 are identical to those
in FCC 7 and FCC 8, respectively, Dean Foods/WhiteWave requested that
the respective regulations be updated to reference the specifications
in FCC 9. Therefore, we are amending Sec. Sec.  172.379 and 172.380 by
adopting the specifications for vitamin D2 and vitamin
D3 in FCC 9 in place of FCC 7 and FCC 8, respectively.

IV. Conclusion

    Based on all data relevant to vitamin D that we reviewed, we
conclude that the petitioned uses of vitamin D in milk and edible
plant-based beverages intended as milk alternatives and edible plant-
based yogurt alternatives within the limits proposed by Dean Food/
WhiteWave are safe. Consequently, we are amending the food additive
regulations as set forth in this document.

V. Public Disclosure

    In accordance with Sec.  171.1(h) (21 CFR 171.1(h)), 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.
171.1(h), we will delete from the documents any materials that are not
available for public disclosure.

VI. Analysis of Environmental Impact

    We previously considered the environmental effects of this rule, as
stated in the August 16, 2013, Federal Register document of petition
for FAP 3A4801. We stated that we had determined, under 21 CFR
25.32(k), 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. 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) 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.
    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.

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

    Our review of this petition was limited to section 409 of the
Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 348).
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, FDA did not consider whether section 301(ll) of the FD&C Act
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) of the FD&C Act. Furthermore, this language is included in all
food additive final rules and therefore should not be construed to be a
statement of the likelihood that section 301(ll) of the FD&C Act
applies.

X. References

    References marked with an asterisk (*) are on display at the
Division of Dockets Management (see ADDRESSES), under Docket No. FDA-
2013-N-0888, and are available for viewing by interested persons
between 9 a.m. and 4 p.m., Monday through Friday; they are also
available electronically at http://www.regulations.gov. References
without asterisks are not on display; they are available as published
articles and books.

1. Committee to Review Dietary Reference Intakes for Vitamin D and
Calcium, Food and Nutrition Board, Institute of Medicine, ``Dietary
Reference Intakes for Calcium and Vitamin D,'' National Academies
Press, Washington, DC, 2011.
2. Taylor, C., K. Patterson, J. Roseland, et al., ``Including Food
25-Hydroxyvitamin D in Intake Estimates May Reduce the Discrepancy
Between Dietary and Serum Measures of Vitamin D Status,'' Journal of
Nutrition, 144:654-659, 2014.
*3. FDA Memorandum from D. Folmer, CFSAN Chemistry Review Group,
Division of Petition Review, to J. Kidwell, Regulatory Group I,
Division of Petition Review, January 27, 2016.
*4. FDA Memorandum from T. Tyler, CFSAN Toxicology Team, Division of
Petition Review, to J. Kidwell, Division of Petition Review,
February 10, 2016.

List of Subjects in 21 CFR Part 172

    Food additives, Incorporation by reference, Reporting and
recordkeeping requirements.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs and
redelegated to the Director, Center for Food Safety and Applied
Nutrition, 21 CFR part 172 is amended as follows:

PART 172--FOOD ADDITIVES PERMITTED FOR DIRECT ADDITION TO FOOD FOR
HUMAN CONSUMPTION

0
1. The authority citation for part 172 continues to read as follows:

    Authority: 21 U.S.C. 321, 341, 342, 348, 371, 379e.

0
2. Amend Sec.  172.379 by revising the first sentence in paragraph (b)
and revising the table in paragraph (c) by removing the entry for ``Soy
beverages'' and adding entries for ``Edible plant-

based beverages intended as milk alternatives'' and ``Edible plant-
based yogurt alternatives'' in alphabetical order to read as follows:

Sec.  172.379  Vitamin D2.

* * * * *
    (b) Vitamin D2 meets the specifications of the 2015 Food
Chemical Codex, 9th edition (through Third Supplement), effective
December 1, 2015, pp. 1260-1261, which is incorporated by reference. *
* *
    (c) * * *

------------------------------------------------------------------------
                                            Maximum  levels in food  (as
             Category of food                          served)
------------------------------------------------------------------------
Edible plant-based beverages intended as    84 IU/100 g.
 milk alternatives.
Edible plant-based yogurt alternatives....  89 IU/100 g.

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

0
3. Amend Sec.  172.380 by revising the first sentence in paragraph (b)
and by adding paragraph (c)(8) to read as follows:

Sec.  172.380  Vitamin D3.

* * * * *
    (b) Vitamin D3 meets the specifications of the 2015 Food
Chemical Codex, 9th edition (through Third Supplement), effective
December 1, 2015, pp. 1261-1262, which is incorporated by reference. *
* *
    (c) * * *
    (8) At levels not to exceed 84 IU per 100 g (800 IU/quart) in milk
that contains more than 42 IU vitamin D per 100 g (400 IU/quart) and
that meets the requirements for foods named by use of a nutrient
content claim and a standardized term in accordance with Sec.  130.10
of this chapter.

    Dated: July 11, 2016.
Susan Bernard,
Director, Office of Regulations, Policy and Social Sciences, Center for
Food Safety and Applied Nutrition.
[FR Doc. 2016-16738 Filed 7-15-16; 8:45 am]
 BILLING CODE 4164-01-P