[Federal Register Volume 83, Number 25 (Tuesday, February 6, 2018)]
[Rules and Regulations]
[Pages 5209-5210]
[FR Doc No: 2018-02351]

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

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 300

[EPA-HQ-SFUND-1992-0007; FRL-9973-60-Region 10]

National Oil and Hazardous Substances Pollution Contingency Plan;
National Priorities List: Deletion of the Vancouver Water Station #4
Superfund Site

AGENCY: Environmental Protection Agency (EPA).

ACTION: Final rule.

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

SUMMARY: The Environmental Protection Agency (EPA) Region 10 announces
the deletion of the Vancouver Water Station #4 Superfund Site (Site)
located in Vancouver, Washington, from the National Priorities List
(NPL). The NPL, promulgated pursuant to section 105 of the
Comprehensive Environmental Response, Compensation, and Liability Act
(CERCLA) of 1980, as amended, is an appendix of the National Oil and
Hazardous Substances Pollution Contingency Plan (NCP). The NPL refers
to the Site as the Vancouver Water Station #4 Contamination Superfund
Site. The EPA and the State of Washington, through the Department of
Ecology, have determined that all appropriate response actions under
CERCLA, have been completed. However, this deletion does not preclude
future actions under Superfund.

DATES: This action is effective February 6, 2018.

ADDRESSES: Docket: EPA has established a docket for this action under
Docket Identification No. EPA-HQ-SFUND-1992-0007. All documents in the
docket are listed on the http://www.regulations.gov website. Although
listed in the index, some information is not publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or
in hard copy at the site information repositories. Locations, contacts,
phone numbers and viewing hours are:
    USEPA Region 10 Records Center, 1200 Sixth Avenue, Suite 900,
Seattle, Washington, Monday through Friday, except Federal holidays,
between 8 a.m. and 5 p.m., Phone:<PHONE_NUMBER> or<PHONE_NUMBER>.
    City of Vancouver Water Resources Education Center, 4600 SE
Columbia Way, Vancouver, Washington, Monday through Friday, except
holidays, between 9:00 a.m. and 5:00 p.m. and Saturday between noon and
5:00 p.m., Phone:<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jeremy Jennings, Remedial Project
Manager, U.S. Environmental Protection Agency, Region 10, ECL-122, 1200
Sixth Avenue, Suite 900, Seattle WA 98101,<PHONE_NUMBER>) email
[email protected].

SUPPLEMENTARY INFORMATION: The site to be deleted from the NPL is:
Vancouver Water Station #4, Vancouver, Washington. A Notice of Intent
to Delete for this Site was published in the Federal Register (82 FR
44545-44548) on September 25, 2017.
    The closing date for comments on the Notice of Intent to Delete was
October 25, 2017. No public comments were received and EPA is
proceeding with deletion.
    EPA maintains the NPL as the list of sites that appear to present a
significant risk to public health, welfare, or the environment.
Deletion from the NPL does not preclude further remedial action.
Whenever there is a significant release from a site deleted from the
NPL, the deleted site may be restored to the NPL without application of
the hazard ranking system. Deletion of a site from the NPL does not
affect responsible party liability in the unlikely event that future
conditions warrant further actions.

List of Subjects in 40 CFR Part 300

    Environmental protection, Air pollution control, Chemicals,
Hazardous waste, Hazardous substances, Intergovernmental relations,
Penalties, Reporting and recordkeeping requirements, Superfund, Water
pollution control, Water supply.

    Dated: January 23, 2018.
Chris Hladick,
Regional Administrator--Region 10.

    For reasons set out in the preamble, 40 CFR part 300 is amended as
follows:

PART 300--NATIONAL OIL AND HAZARDOUS SUBSTANCES POLLUTION
CONTINGENCY PLAN

0
1. The authority citation for part 300 continues to read as follows:

    Authority:  33 U.S.C. 1321(d); 42 U.S.C. 9601-9657; E.O. 13626,
77 FR 56749, 3 CFR, 2013 Comp., p. 306; E.O. 12777, 56 FR 54757, 3
CFR, 1991 Comp., p. 351; E.O. 12580, 52 FR 2923, 3 CFR, 1987 Comp.,
p. 193.

Appendix B to Part 300--[Amended]

0
2. Table 1 of Appendix B to part 300 is amended by removing the entry
``WA'', ``Vancouver Water Station #4 Contamination'', ``Vancouver''.

[FR Doc. 2018-02351 Filed 2-5-18; 8:45 am]
 BILLING CODE 6560-50-P


[Federal Register Volume 78, Number 21 (Thursday, January 31, 2013)]
[Notices]
[Pages 6822-6823]
[FR Doc No: 2013-02093]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0324]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Guidance for
Industry, FDA Staff, and Foreign Governments: Fiscal Year 2012 Medical
Device User Fee Small Business Qualification and Certification

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

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 March
4, 2013.

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 emailed to<EMAIL_ADDRESS>All
comments should be identified with the OMB control number 0910-0508.
Also include the FDA docket number found in brackets in the heading of
this document.

FOR FURTHER INFORMATION CONTACT: Daniel Gittleson, Office of
Information Management, Food and Drug Administration, 1350 Piccard Dr.,
PI50-400B, Rockville, MD 20850,<PHONE_NUMBER>,
<EMAIL_ADDRESS>
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.

Guidance for Industry, FDA Staff, and Foreign Governments: Fiscal Year
2012 Medical Device User Fee Small Business Qualification and
Certification--(OMB Control Number 0910-0508)--Extension

    Section 101 of the Medical Device User Fee and Modernization Act
(MDUFMA) (Pub. L. 107-250) amends the Federal Food, Drug, and Cosmetic
Act (the FD&C Act) to provide for user fees for certain medical device
applications. FDA published a Federal Register notice on August 1, 2011
(76 FR 45826), announcing fees for fiscal year (FY) 2012. To avoid
harming small businesses, MDUFMA provides for reduced or waived fees
for applicants who qualify as a ``small business.'' This means there
are two levels of fees; a standard fee and a reduced or waived small
business fee. You can qualify for a small business fee discount under
MDUFMA if you reported gross receipts or sales of no more than $100
million on your Federal income tax return for the most recent tax year.
If you have any affiliates, partners, or parent firms, you must add
their gross receipts or sales to yours, and the total must be no more
than $100 million. If your gross receipts or sales are no more than $30
million, including all of your affiliates, partners, and parent firms,
you will also qualify for a waiver of the fee for your first (ever)
premarket application (product development protocol, biologics
licensing application, or premarket report). An applicant must pay the
full standard fee unless it provides evidence demonstrating to FDA that
it meets the ``small business'' criteria (Form FDA 3602, ``FY 2012
MDUFMA Small Business Qualification Certification--For a Business
Headquartered in the United States''). The evidence required by MDUFMA
is a copy of the most recent Federal income tax return of the
applicant, and any affiliate, partner, or parent firm. FDA will review
these materials and decide whether an applicant is a ``small business''
within the meaning of MDUFMA.
    The 2007 Amendments provide an alternative way for a foreign
business to qualify as a small business eligible to pay a significantly
lower fee when a medical device user fee must be paid (Form FDA 3602A,
``FY 2012 MDUFMA Foreign Small Business Qualification Certification--
For a Business Headquartered Outside the United States''). Before
passage of the 2007 Amendments, the only way a business could qualify
as a small business was to submit a Federal (U.S.) income tax return
showing its gross receipts or sales that did not exceed a statutory
threshold, currently, $100 million. If a business could not provide a
Federal income tax return, it did not qualify as a small business and
had to pay the standard (full) fee. Because many foreign businesses
have not, and cannot, file a Federal (U.S.) income tax return, this
requirement has effectively prevented those businesses from qualifying
for the small business fee rates. Thus, foreign governments, including
the European Union, have objected. In lieu of a Federal income tax
return, the 2007 Amendments will allow a foreign business to qualify as
a small business by submitting a certification from its national taxing
authority, the foreign equivalent of our Internal Revenue Service. This
certification, referred to as a ``National Taxing Authority
Certification,'' must: Be in English; be from the national taxing
authority of the country in which the business is headquartered;
provide the business' gross receipts or sales for the most recent year,
in both the local currency and in U.S. dollars, and the exchange rate
used in converting local currency to U.S. dollars; provide the dates
during which the reported receipts or sales were collected; and bear
the official seal of the national taxing authority.
    Both Forms FDA 3602 and FDA 3602A are available in the guidance
document, ``Guidance for Industry, Food and Drug Administration Staff,
and Foreign Governments: FY 2012 Medical Device User Fee Small Business
Qualification and Certification,'' available on the Internet at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/UCM267051.pdf.
This guidance describes the criteria FDA will use to decide whether an
entity qualifies as a MDUFMA small business and will help prospective
applicants understand what they need to do to meet the small business
criteria for FY 2012.
    The Form FDA 3602 burden is based on the number of applications
received in the last 3 years. FDA believes most entities that submit
Form FDA 3602A will not have any affiliates, and very few will have
more than three or four affiliates. Based on our experience with Form
FDA 3602A, FDA believes each business will require 1 hour to complete
the form.
    In the Federal Register of April 18, 2012 (77 FR 23267), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. No comments were received.

    FDA estimates the burden of this collection of information as
follows:

                                 Table 1--Estimated Annual Reporting Burden \1\
----------------------------------------------------------------------------------------------------------------
                                                     Number of                        Average
          Form FDA No.               Number of     responses per   Total annual     burden per      Total hours
                                    respondents     respondent       responses       response
----------------------------------------------------------------------------------------------------------------
3602............................           4,200               1           4,200               1           4,200
3602A...........................             900               1             900               1             900
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............           5,100
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
  information.

    Dated: January 25, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-02093 Filed 1-30-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: March 23, 2010 (Volume 75, Number 55)]
[Notices]
[Page 13806-13807]
[DOCID:fr23mr10-117]

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

DEPARTMENT OF TRANSPORTATION

National Highway Traffic Safety Administration

[U.S. DOT Docket Number NHTSA-2010-0027]

Reports, Forms, and Recordkeeping Requirements

AGENCY: National Highway Traffic Safety Administration (NHTSA),
Department of Transportation.

ACTION: Request for public comment on proposed collection of
information.

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

SUMMARY: Before a Federal agency can collect certain information from
the public, it must receive approval from the Office of Management and
Budget (OMB). Under procedures established by the Paperwork Reduction
Act of 1995, before seeking OMB approval, Federal agencies must solicit
public comment on proposed collections of information, including
extensions and reinstatement of previously approved collections.
    This document describes one collection of information for which
NHTSA intends to seek OMB approval.

DATES: Comments must be received on or before May 24, 2010.

ADDRESSES: You may submit comments (identified by DOT Docket No. NHTSA-
2010-0027) to: Docket Management Facility, U.S. Department of
Transportation, 1200 New Jersey Avenue, SE., West Building Ground
Floor, Room W12-140, Washington, DC 20590-0001. Alternatively, you may
submit your comments electronically by logging onto the Docket
Management System (DMS) website at http://dms.dot.gov. Click on
``Help'' to view instructions for filing your comments electronically.
Regardless of how you submit your comments, you should identify the
docket number of this document. You may call the docket at (202) 647-
5527. Docket hours are 9 a.m. to 5 p.m., Monday through Friday, except
Federal holidays.
    Instructions: All submissions must include the agency name and
docket number for this proposed collection of information. Note that
all comments received will be posted without change to http://
www.regulations.gov, including any personal information provided.
Please see the Privacy Act heading below.
    Privacy Act: Anyone is able to search the electronic form of all
comments received into any of our dockets by the name of the individual
submitting the comment (or signing the comments, if submitted on behalf
of an association, business, labor union, etc.). You may review DOT's
complete Privacy Act Statement in the Federal Register published on
April 11, 2000 (65 FR 19477-78) or you may visit http://
DocketInfo.dot.gov.
    Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov or the street
address listed above. Follow the on-line instructions for accessing the
docket.

FOR FURTHER INFORMATION CONTACT: Complete copies of each request for
collection of information may be obtained at no charge from Tamara
Webster, NHTSA, 1200 New Jersey Avenue, SE., W46-490, NTI 200,
Washington, DC 20590. Ms. Webster's telephone number is<PHONE_NUMBER>.
Please identify the relevant collection of information by referring to
its OMB Control Number.

SUPPLEMENTARY INFORMATION: Under the Paperwork Reduction Act of 1995,
before an agency submits a proposed collection of information to OMB
for approval, it must first publish a document in the Federal Register
providing a 60-day comment period and otherwise consult with members of
the public and affected agencies concerning each proposed collection of
information. The OMB has promulgated regulations describing what must
be included in such a document. Under OMB's regulation at 5 CFR
1320.8(d), an agency must ask for public comment on the following:
    (i) Whether the proposed collection of information is necessary for
the proper performance of the functions of the agency, including
whether the information will have practical utility;
    (ii) the accuracy of the agency's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used;
    iii) how to enhance the quality, utility, and clarity of the
information to be collected;
    (iv) how to minimize the burden of the collection of information on
those who are to respond, including the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology, e.g. permitting electronic
submission of responses.
    In compliance with these requirements, NHTSA asks for public
comments on the following proposed collections of information:
    Title: 23 CFR part 1350 Certificate Requirements for Section 2010
Motorcyclist Safety Grant Program.
    OMB Control Number: 2127-0650.
    Affected Public: 50 States, the District of Columbia and Puerto
Rico.
    Form Number: NA.
    Abstract: A motorcyclist safety incentive grant is available to
help States enhance motorcyclist safety training and motorcyclist
awareness programs. To qualify for a first year grant under the grant
program, a State must demonstrate that it has satisfied one of six
criteria: (1) Statewide motorcycle rider training course, (2) statewide
motorcyclists awareness program, (3) reduction of fatalities and
crashes involving motorcycles, (4) statewide impaired driving program,
(5) reduction of fatalities and accidents involving impaired
motorcyclists, and (6) use of fees collected from motorcyclists for
motorcycle programs. In second and subsequent fiscal years, a State
must demonstrate that it has satisfied at least two of six criteria.
    Estimated Annual Burden: 1560 hours.
    Number of Respondents: 50 States, the District of Columbia and
Puerto Rico.
    Comments are invited on: Whether the proposed collection of
information is necessary for the proper performance of the functions of
the Department, including whether the information will have practical
utility; the accuracy of the Department's estimate of the burden of the
proposed information collection; ways to enhance the quality, utility
and clarity of the information to be collected; and ways to minimize
the burden of the collection of information on respondents, including
the use of automated collection techniques or other forms of
information technology.

Marlene Markison,
Associate Administrator, Regional Operations and Program Delivery.
[FR Doc. 2010-6317 Filed 3-22-10; 8:45 am]
BILLING CODE P


[Federal Register: December 17, 2009 (Volume 74, Number 241)]
[Notices]
[Page 66979]
[DOCID:fr17de09-50]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-F-0570]

Lallemand, Inc.; Filing of Food Additive Petition

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

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

SUMMARY:  The Food and Drug Administration (FDA) is announcing that
Lallemand, Inc., has filed a petition proposing that the food additive
regulations be amended to provide for the safe use of vitamin
D2 bakers yeast as a dual purpose nutrient supplement and
leavening agent or dough relaxer in yeast-containing baked products.

FOR FURTHER INFORMATION CONTACT: Judith Kidwell, 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: Under the Federal Food, Drug, and Cosmetic
Act (sec. 409(b)(5) (21 U.S.C. 348(b)(5))), notice is given that a food
additive petition (FAP 9A4779) has been filed by Lallemand, Inc., c/o
Dennis T. Gordon, 117 N. Welcome Slough Rd., Puget Island, Cathlamet,
WA 98612. The petition proposes to amend the food additive regulations
in part 172 Food Additives Permitted for Direct Addition to Food for
Human Consumption (21 CFR part 172) to provide for the safe use of
vitamin D2 bakers yeast as a dual purpose nutrient
supplement and leavening agent or dough relaxer in yeast-containing
baked products.
    The agency has 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. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

    Dated: December 8, 2009.
Laura M. Tarantino,
Director, Office of Food Additive Safety, Center for Food Safety and
Applied Nutrition.
[FR Doc. E9-29961 Filed 12-16-09; 8:45 am]

BILLING CODE 4160-01-S