[Federal Register: June 19, 2008 (Volume 73, Number 119)]
[Notices]
[Page 34940-34941]
[DOCID:fr19jn08-72]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0170]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Premarket
Notification for a New Dietary Ingredient

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing that a
proposed collection of information has been submitted to the Office of
Management and Budget (OMB) for review and clearance under the
Paperwork Reduction Act of 1995.

DATES: Fax written comments on the collection of information by July
21, 2008.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be faxed to the Office
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer,
FAX:<PHONE_NUMBER>, or e-mailed to<EMAIL_ADDRESS>All comments
should be identified with the OMB control number 0910-0330. Also
include the FDA docket number found in brackets in the heading of this
document.

FOR FURTHER INFORMATION CONTACT: Jonna Capezzuto, Office of the Chief
Information Officer (HFA-250), Food and Drug Administration, 5600
Fishers Lane, Rockville, MD 20857,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has
submitted the following proposed collection of information to OMB for
review and clearance.

Premarket Notification for a New Dietary Ingredient--(OMB Control
Number 0910-0330)--Extension

    Section 413(a) of the Federal Food, Drug, and Cosmetic Act (the
act) (21 U.S.C. 350b(a)) provides that at least 75 days before the
introduction or delivery for introduction into interstate commerce of a
dietary supplement that contains a new dietary ingredient, a
manufacturer or distributor of dietary supplements or of a new dietary
ingredient is to submit to FDA (as delegate for the Secretary of Health
and Human Services) information upon which the manufacturer or
distributor has based its conclusion that a dietary supplement
containing a new dietary

ingredient will reasonably be expected to be safe. Part 190 (21 CFR
part 190) implements these statutory provisions. Section 190.6(a)
requires each manufacturer or distributor of a dietary supplement
containing a new dietary ingredient, or of a new dietary ingredient, to
submit to the Office of Nutrition, Labeling, and Dietary Supplements
notification of the basis for their conclusion that said supplement or
ingredient will reasonably be expected to be safe. Section 190.6(b)
requires that the notification include the following: (1) The complete
name and address of the manufacturer or distributor, (2) the name of
the new dietary ingredient, (3) a description of the dietary
supplements that contain the new dietary ingredient, and (4) the
history of use or other evidence of safety establishing that the
dietary ingredient will reasonably be expected to be safe.
    The notification requirements described previously are designed to
enable FDA to monitor the introduction into the food supply of new
dietary ingredients and dietary supplements that contain new dietary
ingredients, in order to protect consumers from unsafe dietary
supplements. FDA uses the information collected under these regulations
to help ensure that a manufacturer or distributor of a dietary
supplement containing a new dietary ingredient is in full compliance
with the act.
    In the Federal Register of March 26, 2008 (73 FR 16020), FDA
published a 60-day notice requesting public comment on the information
collection provisions. No comments were received.

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours per
                    21 CFR Section                         Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
190.6                                                                  71                     1                 71                 20              1,420
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

    The agency believes that there will be minimal burden on the
industry to generate data to meet the requirements of the premarket
notification program because the agency is requesting only that
information that the manufacturer or distributor should already have
developed to satisfy itself that a dietary supplement containing a new
dietary ingredient is in full compliance with the act. However, the
agency estimates that extracting and summarizing the relevant
information from the company's files and presenting it in a format that
will meet the requirements of section 413 of the act will require a
burden of approximately 20 hours of work per submission.
    The estimated number of premarket notifications and hours per
response is an average based on the agency's experience with
notifications received during the last 3 years (i.e., 2005, 2006, and
2007), and information from firms that have submitted recent premarket
notifications.

    Dated: June 13, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-13818 Filed 6-18-08; 8:45 am]

BILLING CODE 4160-01-S


BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

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								:

In the matter of						:

								:

	ALL U.S. AIR CARRIERS			:	Docket OST-01-11065

								:

Waiver of the dormancy conditions on limited-	:

entry route authority					:

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NOTICE OF

CONTINENTAL MICRONESIA, INC.

Communications with respect to this document should be sent to:

William Meehan

President

CONTINENTAL MICRONESIA, INC.

P.O. Box 8778-G

Guam International Airport

Tamuning, Guam  96911

	R. Bruce Keiner, Jr.

CROWELL & MORING LLP

1001 Pennsylvania Avenue, N.W.

Washington, DC  20004-2595

(202) 624-2615

Counsel for

Continental Airlines, Inc.

February 15, 2002

BEFORE THE

DEPARTMENT OF TRANSPORTATION

WASHINGTON, D.C.

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								:

In the matter of						:

								:

	ALL U.S. AIR CARRIERS			:	Docket OST-01-11065

								:

Waiver of the dormancy conditions on limited-	:

entry route authority					:

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NOTICE OF

CONTINENTAL MICRONESIA, INC.

	Pursuant to Orders 2001-11-15 and 2002-2-2, Continental Micronesia is providing the Department with a list of the limited-entry route authority subject to dormancy conditions it will not be using beginning April 1, 2002.

	Continental Micronesia will not be operating service between Honolulu and Tokyo as of April 1, 2002.  Continental Micronesia has been awarded waivers of the dormancy condition applicable to its Honolulu-Tokyo authority (see, e.g., Notice of Action Taken dated August 3, 2000 in Docket OST-98-3419 and Orders 2001-11-5 and 2002-2-2 issued in this docket), and Continental Micronesia is submitting a

request for a waiver of the dormancy condition applicable to its Honolulu-Tokyo frequencies today in a separate docket.

						Respectfully submitted,

						CROWELL & MORING LLP

						/s/ R. Bruce Keiner, Jr.

						_______________________________

						     R. Bruce Keiner, Jr.

						       HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS> 						     Counsel for

						     Continental Micronesia, Inc.

February 15, 2002

1881895

CERTIFICATE OF SERVICE

	I certify that I have this date served a copy of the foregoing document on the following persons in accordance with the Department’s Rules of Practice:

Bruce H. Rabinovitz

Jeffrey A. Manley

Wilmer Cutler & Pickering

2445 M Street, N.W.

Washington, D.C.  20037

(for United)

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>   HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS> 	Marshall S. Sinick

Squire, Sanders & Dempsey L.L.P.

1201 Pennsylvania Avenue, N.W.

Suite 500

Washington, D.C.   20004

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

John R. Byerly

Deputy Assistant Secretary

  for Transportation Affairs

Department of State

2201 C Street, N.W., Room 5830

Washington, D.C.  20520

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS> 	HollyBeth Anderson

Vice President – International

Metro Atlanta Chamber of Commerce

235 International Boulevard, NW

Atlanta, GA  30303

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

Carl B. Nelson, Jr.

Associate General Counsel

American Airlines, Inc.

1101 17th Street, NW, #600

Washington, DC  20036

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS> 	Carlos Martel

Kim Brown

Kevin Langston

Georgia Department of Industry & Trade

285 Peachtree Center Ave.

Atlanta, GA  30303

Miguel Southwell

Director of Marketing & Public Relations

City of Atlanta

Hartsfield Atlanta International Airport

Suite 300

P.O. Box 20509

Atlanta, GA 30320	Robert E. Cohn

Alexander Van der Bellen

Shaw Pittman

2300 N Street, NW

Washington, DC  20037

 HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

Joanne W. Young

Baker & Hostetler, LLP

Washington Square

1050 Connecticut Avenue, N.W.

Suite 1100

Washington, D.C.   20036-5304

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS> 	Donald T. Bliss

O’Melveny & Myers LLP

555 13th Street, N.W.

Washington, D.C.   20004

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

Jonathan B. Hill

Dow, Lohnes & Albertson

1200 New Hampshire Avenue, N.W.

Suite 800

Washington, D.C.   20036-6802

  HYPERLINK<EMAIL_ADDRESS><EMAIL_ADDRESS>

February 15, 2002

/s/ R. Bruce Keiner, Jr.

_______________________________

     R. Bruce Keiner, Jr.

 	Common names are used for airlines.

 	Continental Micronesia’s allocation of five frequencies was awarded by Order 98-5-17 in Docket OST-98-3419.

(…continued)

(continued…)

Notice of Continental Micronesia

Page   PAGE  4


[Federal Register: June 13, 2008 (Volume 73, Number 115)]
[Rules and Regulations]
[Page 33691-33692]
[DOCID:fr13jn08-11]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 520

Oral Dosage Form New Animal Drugs; Deracoxib

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending the animal
drug regulations to reflect approval of a supplemental new animal drug
application (NADA) filed by Novartis Animal Health US, Inc. The
supplemental NADA provides for the addition of a 50-milligram size
deracoxib tablet which is used for the control of pain and inflammation
in dogs.

DATES: This rule is effective June 13, 2008.

FOR FURTHER INFORMATION CONTACT: Melanie R. Berson, Center for
Veterinary Medicine (HFV-110), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855,<PHONE_NUMBER>, e-mail:
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Novartis Animal Health US, Inc., 3200
Northline Ave., suite 300, Greensboro, NC 27408, filed a supplement to
NADA 141-203 that provides for the addition of a 50-milligram size of
DERAMAXX (deracoxib) Chewable Tablets, used for the control of pain and
inflammation in dogs. The supplemental NADA is approved as of May 16,
2008, and 21 CFR 520.538 is amended to reflect the approval.
    In accordance with the freedom of information provisions of 21 CFR
part 20 and 21 CFR 514.11(e)(2)(ii), a summary of safety and
effectiveness data and information submitted to support approval of
this application may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852, between 9 a.m. and 4 p.m., Monday through Friday.
    The agency has determined under 21 CFR 25.33 that this action is of
a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
    This rule does not meet the definition of ``rule'' in 5 U.S.C.
804(3)(A) because it is a rule of ``particular applicability.''
Therefore, it is not subject to the congressional review requirements
in 5 U.S.C. 801 808.

List of Subjects in 21 CFR Part 520

    Animal drugs.

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 Veterinary Medicine, 21 CFR part 520 is
amended as follows:

PART 520--ORAL DOSAGE FORM NEW ANIMAL DRUGS

0
1. The authority citation for 21 CFR part 520 continues to read as
follows:

    Authority: 21 U.S.C. 360b.

Sec.  520.538  [Amended]

0
2. In paragraph (a) of Sec.  520.538, remove ``25, 75, or 100
milligrams'' and in its place add ``25, 50, 75, or 100 milligrams''.

    Dated: June 4, 2008.
Bernadette Dunham,
Director, Center for Veterinary Medicine.
[FR Doc. E8-13353 Filed 6-12-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 85, Number 45 (Friday, March 6, 2020)]
[Notices]
[Page 13161]
[FR Doc No: 2020-04662]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-1006-23-Region 9]

Santa Ana Hollister (Formerly M.K. Ballistics) Removal Site,
Hollister, CA; Notice of Proposed CERCLA Settlement Agreement for
Recovery of Past Response Costs

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice; request for comment.

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SUMMARY: In accordance with the Comprehensive Environmental Response,
Compensation and Liability Act of 1980, as amended (CERCLA), notice is
hereby given of a proposed administrative settlement for recovery of
response costs concerning the Santa Ana Hollister (Formerly M.K.
Ballistics) Removal Site in Hollister, California. The settlement is
entered into pursuant to Section 122(h)(1) of CERCLA, and it requires
the settling parties to reimburse EPA $121,500 in response costs that
EPA incurred at the Site.

DATES: EPA will receive written comments relating to this proposed
settlement until April 6, 2020.

ADDRESSES: The proposed settlement is available for public inspection
at EPA Region IX, 75 Hawthorne Street, San Francisco, California. A
copy of the proposed settlement may be obtained from Myles Saron, EPA
Region IX, 75 Hawthorne Street, ORC-3, San Francisco, CA 94105,
telephone number<PHONE_NUMBER>. Comments should reference the Santa Ana
Hollister (Formerly M.K. Ballistics) Removal Site, Hollister,
California and should be addressed to Mr. Saron at the above address.

FOR FURTHER INFORMATION CONTACT: Myles Saron, Attorney Adviser (ORC-3),
Office of Regional Counsel, U.S. EPA Region IX, 75 Hawthorne Street,
San Francisco, CA 94105; phone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>;
email<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: In accordance with Section 122(i) of the
Comprehensive Environmental Response, Compensation and Liability Act of
1980, as amended (CERCLA), 42 U.S.C. 9622(i), notice is hereby given of
a proposed administrative settlement for recovery of response costs
concerning the Santa Ana Hollister (Formerly M.K. Ballistics) Removal
Site in Hollister, California. The settlement is entered into pursuant
to Section 122(h)(1) of CERCLA, 42 U.S.C. 9622(h)(1), and it requires
the settling parties to reimburse EPA $121,500 in response costs that
EPA incurred at the Site. The settlement includes a covenant not to sue
the settling parties pursuant to Sections 106 or 107(a) of CERCLA, 42
U.S.C. 9606 or 9607(a). For thirty (30) days following the date of
publication of this Notice in the Federal Register, the Agency will
receive written comments relating to the settlement. The Agency will
consider all comments received and may modify or withdraw its consent
to the settlement if comments received disclose facts or considerations
that indicate the proposed settlement is inappropriate, improper, or
inadequate. The Agency's response to any comments received will be
available for public inspection at 75 Hawthorne Street, San Francisco,
CA 94105.
    Parties to the Proposed Settlement: Gil Zuniga, Margaret Zuniga
Healy, Vincent M. Zuniga, Mary A. Zuniga, Steven M Zuniga, and Sheron
Johnson.

    Dated: February 20, 2020.
Enrique Manzanilla,
Director, Superfund Division, U.S. EPA, Region IX.
[FR Doc. 2020-04662 Filed 3-5-20; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register Volume 79, Number 182 (Friday, September 19, 2014)]
[Notices]
[Page 56365]
[FR Doc No: 2014-22400]

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ENVIRONMENTAL PROTECTION AGENCY

[ER-FRL-9017-1]

Environmental Impact Statements; Notice of Availability

    Responsible Agency: Office of Federal Activities, General
Information<PHONE_NUMBER> or http://www.epa.gov/compliance/nepa/.

Weekly receipt of Environmental Impact Statements
Filed 09/08/2014 Through 09/12/2014
Pursuant to 40 CFR 1506.9.

Notice

    Section 309(a) of the Clean Air Act requires that EPA make public
its comments on EISs issued by other Federal agencies. EPA's comment
letters on EISs are available at: http://www.epa.gov/compliance/nepa/eisdata.html.

EIS No. 20140264, Draft Supplement, FHWA, IL, US 30 (FAP 309), From IL-
136 to IL-40, Comment Period Ends: 11/03/2014, Contact: Catherine A.
Batey<PHONE_NUMBER>.
EIS No. 20140265, Final EIS, USFS, OR, Oregon Dunes NRA Management Area
10 (C) Designated Routes Project, Review Period Ends: 11/03/2014,
Contact: Angela Morris<PHONE_NUMBER>.
EIS No. 20140266, Draft EIS, FRA, IL, Chicago--Detroit/Pontiac
Passenger Rail Corridor Program, Comment Period Ends: 11/03/2014,
Contact: Andrea Martin<PHONE_NUMBER>.
EIS No. 20140267, Draft EIS, WAPA, CO, Estes to Flatiron Transmission
Lines Rebuild Project (DOE/EIS-0483), Comment Period Ends: 11/03/2014,
Contact: Mark Wieringa<PHONE_NUMBER>.
EIS No. 20140268, Final EIS, USACE, KS, Removal and Disposal of
Sediment and Restoration of Water Storage at John Redmond Reservoir,
Review Period Ends: 10/20/2014, Contact: David Gade<PHONE_NUMBER>.
EIS No. 20140269, Final Supplement, BOEM, 00, Gulf of Mexico OCS Oil
and Gas Lease Sales: 2015-2017, Central Planning Area Lease Sales 235,
241, and 247, Review Period Ends: 10/20/2014, Contact: Mr. Gary D.
Goeke<PHONE_NUMBER>.
EIS No. 20140270, Final EIS, NRC, 00, Generic--Continued Storage of
Spent Nuclear Fuel NUREG-2157, Review Period Ends: 10/20/2014, Contact:
Sarah L. Lopas<PHONE_NUMBER>.
EIS No. 20140271, Final EIS, FHWA, WI, West Waukesha Bypass, Review
Period Ends: 11/18/2014, Contact: George Poirier<PHONE_NUMBER>.

Amended Notices

EIS No. 20140241, Draft Supplement, FHWA, CO, I-70 East, from I-25 to
Tower Road, Comment Period Ends: 10/31/2014, Contact: Chris Horn 720-
963-3017. Revision to FR Notice Published 09/05/2014; Extending Comment
Period from 10/17/2014 to 10/31/2014.

    Dated: September 16, 2014.
Cliff Rader,
Director, NEPA Compliance Division, Office of Federal Activities.
[FR Doc. 2014-22400 Filed 9-18-14; 8:45 am]
BILLING CODE 6560-50-P