[Federal Register: December 1, 2008 (Volume 73, Number 231)]
[Notices]
[Page 72785]
[DOCID:fr01de08-49]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13203-000]

FFP Missouri 22, LLC; Notice of Preliminary Permit Applications
Accepted for Filing and Soliciting Comment, Motions To Intervene, and
Competing Applications

November 20, 2008..
    On April 22, 2008, FFP Missouri 22, LLC each filed an application,
pursuant to section 4(f) of the Federal Power Act, proposing to study
the feasibility of the Missouri River 22 Project, to be located on the
Missouri River in Saline, Chariton, and Carroll Counties, Missouri.
    The proposed Missouri River 22 Project consists of: (1) 7,560
proposed 20 kilowatt Free Flow generating units having a total
installed capacity of 151.2 megawatts, (2) a proposed transmission
line, and (3) appurtenant facilities. The FFP Missouri 22, LLC, project
would have an average annual generation of 662.26 gigawatt-hours and be
sold to a local utility.
    Applicant Contact: Mr. Dan Irvin, FFP Missouri 22, LLC, 69 Bridge
Street, Manchester, MA 01944, phone<PHONE_NUMBER>.
    FERC Contact: Robert Bell,<PHONE_NUMBER>.
    Deadline for filing comments, motions to intervene, competing
applications (without notices of intent), or notices of intent to file
competing applications: 60 days from the issuance of this notice.
Comments, motions to intervene, notices of intent, and competing
applications may be filed electronically via the Internet. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. If unable to be filed electronically,
documents may be paper-filed. To paper-file, an original and eight
copies should be mailed to: Kimberly D. Bose, Secretary, Federal Energy
Regulatory Commission, 888 First Street, NE., Washington, DC 20426. For
more information on how to submit these types of filings please go to
the Commission's Web site located at http://www.ferc.gov/filing-
comments.asp. More information about this project can be viewed or
printed on the ``eLibrary'' link of Commission's Web site at http://
www.ferc.gov/docs-filing/elibrary.asp. Enter the docket number (P-
13203) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
 [FR Doc. E8-28303 Filed 11-28-08; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 221 (Friday, November 19, 2021)]
[Notices]
[Pages 64941-64943]
[FR Doc No: 2021-25300]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-D-0268]

Agency Information Collection Activities; Submission for Office
of Management and Budget Review; Comment Request; Labeling of Certain
Beers Subject to the Labeling Jurisdiction of the Food and Drug
Administration

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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: Submit written comments (including recommendations) on the
collection of information by December 20, 2021.

ADDRESSES: To ensure that comments on the information collection are
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under Review--Open for Public
Comments'' or by using the search function. The OMB control number for
this information collection is 0910-0728. Also include the FDA docket
number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Ila S. Mizrachi, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852,<PHONE_NUMBER>,
[email protected].

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.

Labeling of Certain Beers Subject to the Labeling Jurisdiction of the
Food and Drug Administration

OMB Control Number 0910-0728--Extension

    The definition of ``food'' under the Federal Food, Drug, and
Cosmetic Act (FD&C Act (21 U.S.C. 321(f))) includes ``articles used for
food or drink'' and thus includes alcoholic beverages. As such,
alcoholic beverages are subject to the FD&C Act's adulteration and
misbranding provisions and implementing regulations related to food.
For example, manufacturers of alcoholic beverages are responsible for
adhering to the registration of food facilities requirements in 21 CFR
part 1 and to the good manufacturing practice regulations in 21 CFR
part 110. There are also certain requirements for nutrition labeling on
menus, menu boards, and other written materials for alcohol beverages
served in restaurants or similar retail food establishments in 21 CFR
part 101. However, as reflected in a 1987 Memorandum of Understanding
between FDA and the Alcohol and Tobacco Tax and Trade Bureau (TTB), TTB
is responsible for the dissemination and enforcement of regulations
with respect to the labeling of distilled spirits, certain wines, and
malt beverages issued in the Federal Alcohol Administration Act (the
FAA Act). In TTB Ruling 2008-3, dated July 7, 2008, TTB clarified that
certain beers, which are not made from both malted

barley and hops but are instead made from substitutes for malted barley
(such as sorghum, rice, or wheat) or are made without hops, do not meet
the definition of a ``malt beverage'' under the FAA Act. Accordingly,
TTB stated in its ruling that such products (other than sak[eacute],
which is classified as a wine under the FAA Act), are not subject to
the labeling, advertising, or other provisions of TTB regulations
issued under the FAA Act.
    In cases where an alcoholic beverage is not covered by the labeling
provisions of the FAA Act, the product is subject to ingredient and
other labeling requirements under the FD&C Act and the implementing
regulations that we administer. In addition, as provided for under the
Fair Packaging and Labeling Act (FPLA), alcoholic beverages that are
not covered by the labeling provisions of the FAA Act are subject to
the provisions of the FPLA, which we administer.
    Therefore, the beers described in TTB's ruling as not being a
``malt beverage'' are subject to the labeling requirements under the
FD&C Act and FPLA, and our implementing regulations. In general, we
require that food products under our jurisdiction be truthfully and
informatively labeled in accordance with the FD&C Act, the FPLA, and
FDA's regulations. Furthermore, some TTB labeling requirements, such as
the Government Health Warning Statement under the Alcoholic Beverage
Labeling Act and certain marking requirements under the Internal
Revenue Code, continue to apply to these products.
    Persons with access to the internet may obtain the guidance
entitled ``Labeling of Certain Beers Subject to the Labeling
Jurisdiction of the Food and Drug Administration,'' located at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-labeling-certain-beers-subject-labeling-jurisdiction-food-and-drug-administration. This guidance is intended to assist
manufacturers on how to label bottled or otherwise packaged beers that
are subject to our labeling laws and regulations.
    Our food labeling regulations under parts 101, 102, 104, and 105
(21 CFR parts 101, 102, 104, and 105) were issued under the authority
of sections 4, 5, and 6 of the FPLA (15 U.S.C. 1453, 1454, and 1455)
and under sections 201, 301, 402, 403, 409, 411, 701, and 721 of the
FD&C Act (21 U.S.C. 321, 331, 342, 343, 348, 350, 371, and 379e). Most
of these regulations derive from section 403 of the FD&C Act, which
provides that a food product shall be deemed to be misbranded if, among
other things, its label or labeling fails to bear certain required
information concerning the food product, is false or misleading in any
particular, or bears certain types of unauthorized claims. The
disclosure requirements and other collections of information in the
regulations in parts 101, 102, 104, and 105 are necessary to ensure
that food products produced or sold in the United States are in
compliance with the labeling provisions of the FD&C Act and the FPLA.
    The primary user of the information to be disclosed on the label or
labeling of food products is the consumer that purchases the food
product. Consumers will use the information to assist them in making
choices concerning their purchase of a food product, including choices
related to substances that the consumer must avoid to prevent adverse
reactions. This information also enables the consumer to determine the
role of the food product in a healthful diet. Additionally, FDA intends
to use the information to determine whether a manufacturer or other
supplier of food products is meeting its statutory and regulatory
obligations. Failure of a manufacturer or other supplier of food
products to label its products in compliance with section 403 of the
FD&C Act and parts 101, 102, 104, and 105 of FDA's food labeling
regulations may result in a product being misbranded under the FD&C
Act, subjecting the firm and product to regulatory action.
    Description of Respondents: The respondents to this collection of
information are manufacturers of beers that are subject to our labeling
laws and regulations.
    In the Federal Register of May 21, 2021 (86 FR 27631), FDA
published a 60-day notice requesting public comment on the proposed
collection of information. We received two comments pertaining to the
necessity and practical utility of the information being collected and
the accuracy of our burden estimate.
    (Comment 1) One comment questioned the necessity and practical
utility of treating beer as a ``food'' making it subject to food
labeling regulations. A related comment questioned the need to label
beer at all.
    (Response) As stated in the guidance as well in the above-
referenced 60-day notice, the definition of ``food'' under the FD&C Act
(see 21 U.S.C. 321(f)), includes ``articles used for food or drink''
and thus includes alcoholic beverages. In cases where an alcoholic
beverage is not covered by the labeling provisions of the FAA Act, the
product is subject to ingredient and other labeling requirements under
the FD&C Act and the implementing regulations that are administered by
FDA. In addition, as provided for under the FPLA, alcoholic beverages
that are not covered by the labeling provisions of the FAA Act are
subject to the provisions of the FPLA, which is administered by FDA.
    Therefore, the beers described in the TTB's Ruling as not being a
``malt beverage'' are subject to the labeling requirements under the
FD&C Act and FPLA, and FDA's implementing regulations. In general, FDA
requires that food products under its jurisdiction be truthfully and
informatively labeled in accordance with the FD&C Act, the FPLA, and
FDA's regulations.
    The primary user of the information to be disclosed on the label or
labeling of food products is the consumer that purchases the food
product. Consumers will use the information to assist them in making
choices concerning their purchase of a food product, including choices
related to substances that the consumer must avoid to prevent adverse
reactions. This information also enables the consumer to determine the
role of the food product in a healthful diet.
    (Comment 2) One comment argued that the burden estimate
underestimated the number of respondents affected by this collection.
    (Response) This collection of information applies to alcoholic
beverages not covered by the labeling provisions of the FAA Act. Our
estimate of the number of respondents is based on the number of
regulatory submissions to TTB for beers that do not meet the definition
of a ``malt beverage'' under the FAA Act. Based on its records of
submissions received from manufacturers of such products, TTB estimates
the annual number of respondents to be 12.
    We estimate the burden of this collection of information as
follows:

                                               Table 1--Estimated Annual Third-Party Disclosure Burden \1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                  Number of
          21 CFR section; activity               Number of     disclosures per   Total annual         Average burden per disclosure         Total hours
                                                respondents      respondent       disclosures
--------------------------------------------------------------------------------------------------------------------------------------------------------
101.3 and 101.22; statement of identity                   12                 2              24  0.5 (30 minutes)........................              12
 labeling requirements.
101.4; ingredient labeling requirements.....              12                 2              24  1.......................................              24
101.5; requirement to specify the name and                12                 2              24  0.25 (15 minutes).......................               6
 place of business of the manufacturer,
 packer, or distributor.
101.9; labeling requirements for disclosure               12                 2              24  4.......................................              96
 of nutrition information.
101.7; declaration of net quantity of                     12                 2              24  0.5 (30 minutes)........................              12
 contents.
Section 403(w)(1) of the FD&C Act;                        12                 2              24  1.......................................              24
 declaration of food allergens.
Guidance document entitled ``Labeling of                  12                 1              12  1.......................................              12
 Certain Beers Subject to the Labeling
 Jurisdiction of the Food and Drug
 Administration''.
                                             -----------------------------------------------------------------------------------------------------------
    Total...................................  ..............  ................  ..............  ........................................             186
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate. Our estimate of the number of respondents is based on the
number of regulatory submissions to TTB for beers that do not meet the
definition of a ``malt beverage'' under the FAA Act. Based on its
records of submissions received from manufacturers of such products,
TTB estimates the annual number of respondents to be 12 and the annual
number of disclosures to be 24.
    Our estimates of the average burden per disclosure for each
collection provision are based on our experience with food labeling
under the Agency's jurisdiction. The estimated average burden per
disclosure for Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.7
(21 CFR 101.3, 101.4, 101.5, 101.9, 101.22, and 101.7) are equal to,
and based upon, the estimated average burden per disclosure approved by
OMB control number 0910-0381. We further estimate that the labeling
burden of section 403(w)(1) of the FD&C Act, which specifies
requirements for the declaration of food allergens, will be 1 hour
based upon the similarity of the requirements to that of Sec.  101.4.
Finally, we estimate that a respondent will spend 1 hour reading the
guidance.
    The guidance also refers to previously approved collections of
information found in our regulations. The collections of information in
Sec. Sec.  101.3, 101.4, 101.5, 101.9, 101.22, and 101.7 have been
approved under OMB control number 0910-0381. Allergen labeling of these
beers under section 403(w)(1) of the FD&C Act, which was added by the
Food Allergen Labeling and Consumer Protection Act of 2004, has been
approved under OMB control number 0910-0792.

    Dated: November 15, 2021.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2021-25300 Filed 11-18-21; 8:45 am]
BILLING CODE 4164-01-P


EXHIBIT 4 PART B PERMIT APPLICATION, PERMIT MODIFICATIONS, AND SPECIAL PERMITS TOTAL ESTIMATED ANNUAL RESPONDENT BURDEN AND COST SUMMARY Exhibit Title Annual Activities Annual Burden Annual Labor Cost Annual Capital/

Startup Cost Annual O& M Cost Total Annual Cost Exhibit 1 Demonstrations and Exemptions from Requirements 0 0 $ 0 $ 0 $ 0 $ 0 Exhibit 2 Contents of the Part B Application 677 9,484 $ 621,127 $ 20,053 $ 2,196,825 $ 2,838,005 Exhibit 3 Permit Modifications and Special Permits 206 2,725 $ 162,555 $ 0 $ 251,360 $ 413,915 Annual Total 883 12,209 $ 783,682 $ 20,053 $ 2,448,185 $ 3,251,920 3 Year Total 2,649 36,627 $ 2,351,046 $ 60,159 $ 7,344,555 $ 9,755,760 EXHIBIT 8 PART B PERMIT APPLICATION, PERMIT MODIFICATIONS, AND SPECIAL PERMITS TOTAL ESTIMATED ANNUAL AGENCY BURDEN AND COST SUMMARY Exhibit Title Annual Activities Annual Burden Annual Labor Cost Annual Capital/

Startup Cost Annual O& M Cost Total Annual Cost Exhibit 5 Demonstrations and Exemptions from Requirements 0 0 $ 0 $ 0 $ 0 $ 0 Exhibit 6 Contents of the Part B Application 137 2,521 $ 128,998 $ 0 $ 0 $ 128,998 Exhibit 7 Permit Modifications and Special Permits 121 1,033 $ 57,042 $ 0 $ 0 $ 57,042 Annual Total 258 3,554 $ 186,040 $ 0 $ 0 $ 186,040 3 Year Total 774 10,662 $ 558,120 $ 0 $ 0 $ 558,120 EXHIBIT 9 PART B PERMIT APPLICATION, PERMIT MODIFICATIONS, AND SPECIAL PERMITS AVERAGE ANNUAL RESPONDENT BURDEN ( BY TYPE OF REQUIREMENT)

Type of Requirement Annual Reporting Burden Annual Record Keeping Burden Total Annual Burden DEMONSTRATIONS AND EXEMPTIONS FROM REQUIREMENTS Releases from Regulated Units    Demonstrations and Exemptions from Requirements    CONTENTS OF THE PART B APPLICATION Legal Review  100.00 100.00 General Information    Permit Application    General Requirements    General Facility Standards 145.41 9.00 154.41 Financial Assurance 16.00 2.00 18.00 Other Part B Requirements 11.50 0.50 12.00 Ground Water Protection 197.75 3.71 201.46 Solid Waste Management Units 10.11 0.27 10.38 Specific Part B Information Requirements 73.55 0.64 74.20 Schedules of Compliance  0.50 0.50 PERMIT MODIFICATIONS AND SPECIAL PERMITS Permit Modifications 61.65 3.95 65.60 Expiration and Continuation of Permits 112.00 0.75 112.75 Special Forms of Permits 53.00 0.20 53.20 Interim Status


[Federal Register: October 25, 2006 (Volume 71, Number 206)]
[Notices]
[Page 62434-62436]
[DOCID:fr25oc06-38]

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ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OPP-2006-0631; FRL-8083-4]

Agency Information Collection Activities; Proposed Collection;
Comment Request; Recordkeeping Requirements for Certified Applicators
Using 1080 Collars for Livestock Protection; EPA ICR No. 1249.08, OMB
Control No. 2070-0074

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY:  In compliance with the Paperwork Reduction Act (PRA) (44
U.S.C. 3501 et seq.), this document announces that EPA is planning to
submit a request to renew an existing approved Information Collection
Request (ICR) to the Office of Management and Budget (OMB). This ICR,
entitled: ``Recordkeeping Requirements for Certified Applicators Using
1080 Collars for Livestock Protection'' and identified by EPA ICR No.
1249.08 and OMB Control No. 2070-0074, is scheduled to expire on May
31, 2007. Before submitting the ICR to OMB for review and approval, EPA
is soliciting comments on specific aspects of the proposed information
collection.

DATES: Comments must be received on or before December 26, 2006.

ADDRESSES:  Submit your comments, identified by docket identification
(ID) number EPA-HQ-OPP-2006-0631, by one of the following methods:
     Federal eRulemaking Portal: http://www.regulations.gov.

Follow the on-line instructions for submitting comments.
     Mail: Office of Pesticide Programs (OPP) Regulatory Public
Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania
Ave., NW., Washington, DC 20460-0001.
     Delivery: OPP Regulatory Public Docket (7502P),
Environmental Protection Agency, Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. Deliveries are only
accepted during the Docket's normal hours of operation (8:30 a.m. to 4
p.m., Monday through Friday, excluding legal holidays). Special
arrangements should be made for deliveries of boxed information. The
Docket telephone number is<PHONE_NUMBER>.
    Instructions: Direct your comments to docket ID number EPA-HQ-OPP-
2006-0631. EPA's policy is that all comments received will be included
in the public docket without change and may be made available on-line
at http://www.regulations.gov, including any personal information

provided, unless the comment includes information claimed to be
Confidential Business Information (CBI) or other information whose
disclosure is restricted by statute. Do not submit information that you
consider to be CBI or otherwise protected through regulations.gov or e-
mail. The regulations.gov website is an ``anonymous access'' system,
which means EPA will not know your identity or contact information
unless you provide it in the body of your comment. If you send an e-
mail comment directly to EPA without going through regulations.gov your
e-mail address will be automatically captured and included as part of
the comment that is placed in the public docket and made available on
the Internet. If you submit an electronic comment, EPA recommends that
you include your name and other contact information in the body of your
comment and with any disk or CD ROM you submit. If EPA cannot read your

comment due to technical difficulties and cannot contact you for
clarification, EPA may not be able to consider your comment. Electronic
files should avoid the use of special characters, any form of
encryption, and be free of any defects or viruses.
    Docket: All documents in the docket are listed in the docket index.
Although listed in the index, some information is not publicly
available, e.g., CBI 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 in the electronic docket at http://www.regulations.gov
, or, if only available in hard copy, at the OPP

Regulatory Public Docket in Rm. S-4400, One Potomac Yard (South
Building), 2777 S. Crystal Drive, Arlington, VA. The hours of operation
of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through
Friday, excluding legal holidays. The Docket telephone number is (703)
305-5805.

FOR FURTHER INFORMATION CONTACT:  Nathanael R. Martin, Field and
External Affairs Division (7506P), Office of Pesticide Programs,
Environmental Protection Agency, 1200 Pennsylvania Ave., NW.,
Washington, DC 20460-0001; telephone number:<PHONE_NUMBER>; fax
number:<PHONE_NUMBER>; e-mail address<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. What Information is EPA Particularly Interested In?

    Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically
solicits comments and information to enable it to:
    1. Evaluate 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.
    2. Evaluate the accuracy of the Agency's estimates of the burden of
the proposed collection of information, including the validity of the
methodology and assumptions used.
    3. Enhance the quality, utility, and clarity of the information to
be collected.
    4. Minimize the burden of the collection of information on those
who are to respond, including through 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 particular, EPA is requesting comments from
very small businesses (those that employ less than 25) on examples of
specific additional efforts that EPA could make to reduce the paperwork
burden for very small businesses affected by this collection.

II. What Should I Consider When I Prepare My Comments for EPA?

    You may find the following suggestions helpful for preparing your
comments:
    1. Explain your views as clearly as possible and provide specific
examples.
    2. Describe any assumptions that you used.
    3. Provide copies of any technical information and/or data you used
that support your views.
    4. If you estimate potential burden or costs, explain how you
arrived at the estimate that you provide.
    5. Provide specific examples to illustrate your concerns.
    6. Offer alternative ways to improve the collection activity.
    7. Make sure to submit your comments by the deadline identified
under DATES.
    8. To ensure proper receipt by EPA, be sure to identify the docket
ID number assigned to this action in the subject line on the first page
of your response. You may also provide the name, date, and Federal
Register citation.

III. What Information Collection Activity or ICR Does This Action Apply
To?

    Affected entities: Entities potentially affected by this action are
pesticide and other agricultural manufacturers (North American
Industrial Classification System (NAICS) code 325320), e.g., pesticide
registrants whose products include 1080 collars; and government
establishments primarily engaged in the administration of agricultural
pest control programs and regulation (NAICS code 926140) and
environmental quality programs (NAICS code 9241), e.g., goverment
agencies involved in the application of 1080 collars and states
implementing a 1080 collar monitoring program, respectively.
    Title: Recordkeeping Requirements for Certified Applicators Using
1080 Collars for Livestock Protection.
    ICR numbers: EPA ICR No. 1249.08, OMB Control No. 2070-0074.
    ICR status: This ICR is currently scheduled to expire on May 31,
2007. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information, unless it displays
a currently valid OMB control number. The OMB control numbers for EPA's
regulations in title 40 of the CFR, after appearing in the Federal
Register when approved, are listed in 40 CFR part 9, are displayed
either by publication in the Federal Register or by other appropriate
means, such as on the related collection instrument or form, if
applicable. The display of OMB control numbers in certain EPA
regulations is consolidated in 40 CFR part 9.
    Abstract: This ICR affects approximately 40 certified pesticide
applicators who utilize 1080 toxic collars for livestock protection.
Four states (Montana, New Mexico, South Dakota, and Wyoming) monitor
the program and five pesticide registrants are required to keep records
of:
     Number of collars purchased.
     Number of collars attached on livestock.
     Pasture(s) where collared livestock were placed.
     Number and locations of livestock found with ruptured or
punctured collars and the apparent cause of the damage.
     The dates of each attachment, inspection, and removal.
     Number, dates, and approximate location of all collars
lost.
     Locations and dates of all suspected poisonings of humans,
domestic animals or non-target wild animals resulting from collar use
location and species data on each animal poisoned as an apparent result
of the toxic collar.
    Applicators maintain records, and the registrants/lead agencies do
monitoring studies and submit the reports. These records are monitored
by either the: State lead agencies, EPA regional offices, or the
registrants. EPA receives annual monitoring reports from registrants or
state lead agencies.
    Burden statement: The annual public reporting and recordkeeping
burden for this collection of information is estimated as follows:
Average of 9 hours per response for registrant respondents, 40 hours
per response for certified applicator respondents, and 77 hours per
response for state agency respondents. Burden means the total time,
effort, or financial resources expended by persons to generate,
maintain, retain, or disclose or provide information to or for a
Federal Agency. This includes the time needed to review instructions;
develop, acquire, install, and utilize technology and systems for the
purposes of collecting, validating, and verifying information,
processing and maintaining information, and disclosing and providing
information; adjust the existing ways to comply with any previously
applicable instructions and requirements which have

subsequently changed; train personnel to be able to respond to a
collection of information; search data sources; complete and review the
collection of information; and transmit or otherwise disclose the
information.
    The ICR provides a detailed explanation of this estimate, which is
only briefly summarized here:
    Estimated total number of potential respondents: 49.
    Frequency of response: Annual.
    Estimated total average number of responses for each respondent: 1.
    Estimated total annual burden hours: 1,953 hours.
    Estimated total annual costs: $70,261.59.

IV. Are There Changes In the Estimates From the Last Approval?

    There is an increase of 200 hours in the total estimated respondent
burden compared with that identified in the ICR currently approved by
OMB. This increase reflects EPA's estimate of increased numbers of
certified applicators (from 35 certified applicators in 2003 to 40 in
the current ICR). This change is an adjustment.

V. What is the Next Step In the Process for This ICR?

    EPA will consider the comments received and amend the ICR as
appropriate. The final ICR package will then be submitted to OMB for
review and approval pursuant to 5 CFR 1320.12. EPA will issue another
Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce
the submission of the ICR to OMB and the opportunity to submit
additional comments to OMB. If you have any questions about this ICR or
the approval process, please contact the person listed under FOR
FURTHER INFORMATION CONTACT.

List of Subjects

    Environmental protection, Reporting and recordkeeping requirements.

    Dated: October 5, 2006.
James B. Gulliford,
Assistant Administrator, Office of Prevention, Pesticides and Toxic
Substances.
[FR Doc. E6-17779 Filed 10-24-06; 8:45 am]

BILLING CODE 6560-50-S


[Federal Register Volume 78, Number 34 (Wednesday, February 20, 2013)]
[Notices]
[Pages 11921-11923]
[FR Doc No: 2013-03819]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-68919; File No. SR-ISE-2013-08]

Self-Regulatory Organizations; International Securities Exchange,
LLC; Notice of Filing of Proposed Rule Change To Amend the Minimum
Trading Increments for Mini Options

February 13, 2013.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act'' or ``Exchange Act'') \1\ and Rule 19b-4 thereunder,\2\ notice
is hereby given that on February 6, 2013, the International Securities
Exchange, LLC (``Exchange'' or ``ISE'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change as
described in Items I and II below, which Items have been prepared by
the self-regulatory organization. The Commission is publishing this
notice to solicit comments on the proposed rule change from interested
persons.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
---------------------------------------------------------------------------

I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to permit the minimum trading increment for
Mini Options to be the same as the minimum trading increment permitted
for standard options on the same underlying security. The text of the
proposed rule change is available on the Exchange's Web site
www.ise.com, at the principal office of the Exchange, and at the
Commission's Public Reference Room.

II. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

    In its filing with the Commission, the Exchange included statements
concerning the purpose of, and basis for, the proposed rule change and
discussed any comments it received on the proposed rule change. The
text of these statements may be examined at the places specified in
Item IV below. The self-regulatory organization has prepared summaries,
set forth in Sections A, B and C below, of the most significant aspects
of such statements.

A. Self-Regulatory Organization's Statement of the Purpose of, and
Statutory Basis for, the Proposed Rule Change

1. Purpose
    ISE proposes to amend its rules to permit the minimum trading
increment for Mini Options to be the same as the minimum trading
increment permitted for standard options on the same underlying
security. Mini Options overlie 10 equity or ETF shares, rather than the
standard 100 shares.\3\ Mini Options are currently approved on the
following five (5) underlying securities: SPDR S&P 500 ETF (``SPY''),
Apple Inc. (``AAPL''), SPDR Gold Trust (``GLD''), Google Inc.
(``GOOG''), and Amazon.com, Inc. (``AMZN''). Of the five securities on
which Mini Options are permitted, four of them (SPY, AAPL, GLD and
AMZN) participate in the Penny Pilot Program.\4\ Under the Penny Pilot
Program, with the exception of three classes,\5\ the minimum price
variation for all participating options classes is $0.01 for all
quotations in options series that are quoted at less than $3 per
contract and $0.05 for all quotations in options series that are quoted
at $3 per contract or greater. Therefore, the minimum trading increment
for AAPL, GLD, and AMZN is $0.01 for option series under $3 and $0.05
for options quoted at $3 or greater, while the minimum trading
increment for SPY, which is not subject to a price test, is $0.01
across all option series. The Exchange notes that GOOG is not in the
Penny Pilot Program and therefore, standard options in GOOG have a
minimum increment of $0.05 and $0.10

per contract depending on the price at which the standard option in
this class is quoted.
---------------------------------------------------------------------------

    \3\ Mini Options were approved for trading on September 28,
2012. See Securities Exchange Act Release No. 67948 (September 28,
2012), 77 FR 60735 (October 4, 2012) (Approving SR-ISE-2012-58). The
Exchange expects to begin trading Mini Options on March 18, 2013.
    \4\ The Penny Pilot Program, which permits certain options
series to be quoted and traded in increments of $0.01, began on
January 26, 2007. See Securities Exchange Act Release No. 55161
(January 24, 2007), 72 FR 4754 (February 1, 2007). The Penny Pilot
Program has since been extended a number of times and is currently
in place through June 30, 2013. See Securities Exchange Act Release
Nos. 56151 (July 26, 2007), 72 FR 42452 (August 2, 2007); 56564
(September 27, 2007), 72 FR 56412 (October 3, 2007); 57508 (March
17, 2008), 73 FR 15243 (March 21, 2008); 59633 (March 26, 2009), 74
FR 15018 (April 2, 2009); 60222 (July 1, 2009), 74 FR 32994 (July 9,
2009); 60865 (October 22, 2009), 74 FR 55880 (October 29, 2009);
63437 (December 6, 2010), 75 FR 77032 (December 10, 2010); 65968
(December 15, 2011), 76 FR 79723 (December 22, 2011); 67323 (June
29, 2012), 77 FR 40121 (July 6, 2012); and 68424 (December 13,
2012), 77 FR 75241 (December 19, 2012).
    \5\ The three classes are the Nasdaq-100 Index Tracking Stock
(``QQQQ''), the SPDR S&P 500 ETF (``SPY'') and the iShares Russell
2000 Index Fund (``IWM''). QQQQ, SPY and IWM are quoted in $0.01
increments for all options series.
---------------------------------------------------------------------------

    This proposed rule change will permit the minimum trading increment
for Mini Options to be identical to the minimum trading increment
applicable to standard options on the same underlying security. The
Exchange believes having different trading increments for Mini Options
than those permitted for standard options on the same underlying
security would be detrimental to the success of this new product
offering and would also lead to investor confusion. The Exchange notes
that the Commission approved Mini Options on SPY, AAPL, GLD, GOOG and
AMZN because of their high price and current volume levels and because
of the level of retail investor participation in trading options in
these classes. Mini Options are a natural extension to the options
overlying these securities and therefore should retain the most
important characteristic, i.e., trading increments. The Exchange
believes that by reducing the minimum trading increments for Mini
Options, the proposed rule change will provide market participants with
meaningful trading opportunities in this product. Further, quoting and
trading in smaller increments will enable market participants to trade
Mini Options with greater precision as to price. Providing these more
refined increments will permit the Exchange's market makers the
opportunity to provide better fills (meaning less spread than the
current wider minimum increments rules allow) to customers. Therefore,
ISE proposes to amend its rules to permit the listing and trading of
Mini Options in the same increment permitted for standard options on
the same underlying security.
    With this proposed rule change, although Mini Options would be
trading in narrower increments, they would not be considered part of
the Penny Pilot Program.
    The Exchange's proposal to quote and trade certain option classes
that are outside of the Penny Pilot Program in $0.01 increments is not
novel. Specifically, the Commission has permitted ISE to set the
minimum increment for all Foreign Currency Options traded on the
Exchange at $0.01 regardless of the price at which the option is
quoted.\6\ The Commission has also previously approved a proposal by
NASDAQ OMX PHLX, Inc. permitting that exchange to also trade its
foreign currency options in $0.01 increments.\7\
---------------------------------------------------------------------------

    \6\ See Securities Exchange Act Release No. 57019 (December 20,
2007), 72 FR 73937 (December 28, 2007) (Notice of Filing and
Immediate Effectiveness of Proposed Rule Change Relating to Rule
710, Minimum Trading Increments) (SR-ISE-2007-120).
    \7\ See Securities Exchange Act Release No. 56933 (December 7,
2007), 72 FR 71185 (December 14, 2007) (Approving SR-PHLX-2007-70).
---------------------------------------------------------------------------

    In support of this proposed rule change, ISE proposes to amend ISE
Rules 504 and 710. As so [sic] ISE Rule 710, ISE proposes to add new
Supplementary Material .03 which provides that the minimum trading
increment for Mini Options shall be determined in accordance with new
Supplementary Material .13(d) to Rule 504. Proposed Supplementary
Material .13(d) provides that the minimum trading increment for Mini
Options shall be the same as the minimum trading increment permitted
for standard options on the same underlying security.
    With regard to the impact of this proposal on system capacity, the
Exchange represents that it and the Options Price Reporting Authority
have the necessary systems capacity to handle the potential additional
traffic associated with this proposal. The Exchange does not believe
that this increased traffic will become unmanageable since Mini Options
are limited to a fixed number of underlying securities.
2. Statutory Basis
    The basis under the Securities Exchange Act of 1934 (the ``Exchange
Act'') for this proposed rule change is found in Section 6(b)(5), in
that the proposed change is designed to promote just and equitable
principles of trade, will serve to remove impediments to and perfect
the mechanisms of a free and open market and a national market system
and, in general, to protect investors and the public interest. In
particular, the proposed rule change will assure that standard options
and Mini Options on the same underlying security will trade in similar
increments and therefore provide market participants meaningful trading
opportunities and enable them to trade Mini Options with greater
precision as to price. The Exchange also believes the proposed rule
change will avoid investor confusion if both standard options and Mini
Options on the same underlying security are permitted to trade in
similar trading increments. The Exchange further believes that
investors and other market participants will benefit from this proposed
rule change because it proposes to clarify and establish the minimum
trading increment for Mini Options prior to the commencement of
trading. The Exchange believes that investors generally will be
expecting the minimum trading increment for Mini Options to be the same
as the minimum trading increment for standard options on the same
underlying security. This proposed rule change will therefore lessen
investor confusion because Mini Options and standard options on the
same underlying security will have the same minimum trading increment.

B. Self-Regulatory Organization's Statement on Burden on Competition

    This proposed rule change does not impose any burden on competition
that is not necessary or appropriate in furtherance of the purposes of
the Exchange Act. ISE believes that the proposed rule change will in
fact relieve any burden on, or otherwise promote, competition. Mini
Options are currently approved for trading on multiple options
exchanges and all of these exchanges will have the opportunity to
establish minimum trading increment for Mini Options.

C. Self-Regulatory Organization's Statement on Comments on the Proposed
Rule Change Received From Members, Participants or Others

    The Exchange has not solicited, and does not intend to solicit,
comments on this proposed rule change. The Exchange has not received
any unsolicited written comments from members or other interested
parties.

III. Date of Effectiveness of the Proposed Rule Change and Timing for
Commission Action

    Within 45 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    (A) By order approve or disapprove such proposed rule change, or
    (B) Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

    Interested persons are invited to submit written data, views, and
arguments concerning the foregoing, including whether the proposed rule
change is consistent with the Act. Comments may be submitted by any of
the following methods:

Electronic Comments

     Use the Commission's Internet comment form (http://www.sec.gov/rules/sro.shtml ); or
     Send an email to<EMAIL_ADDRESS>Please include
File Number SR-ISE-2013-08 on the subject line.

Paper Comments

     Send paper comments in triplicate to Elizabeth M. Murphy,
Secretary, Securities and Exchange Commission, 100 F Street NE.,
Washington, DC 20549-1090.

All submissions should refer to File Number SR-ISE-2013-08. This file
number should be included on the subject line if email is used. To help
the Commission process and review your comments more efficiently,
please use only one method. The Commission will post all comments on
the Commission's Internet Web site (http://www.sec.gov/rules/sro.shtml). Copies of the submission, all subsequent amendments, all
written statements with respect to the proposed rule change that are
filed with the Commission, and all written communications relating to
the proposed rule change between the Commission and any person, other
than those that may be withheld from the public in accordance with the
provisions of 5 U.S.C. 552, will be available for Web site viewing and
printing in the Commission's Public Reference Room, 100 F Street NE.,
Washington, DC 20549, on official business days between the hours of
10:00 a.m. and 3:00 p.m. Copies of the filing also will be available
for inspection and copying at the principal office of the Exchange. All
comments received will be posted without change; the Commission does
not edit personal identifying information from submissions. You should
submit only information that you wish to make available publicly. All
submissions should refer to File Number SR-ISE-2013-08 and should be
submitted on or before March 13, 2013.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\8\
---------------------------------------------------------------------------

    \8\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2013-03819 Filed 2-19-13; 8:45 am]
BILLING CODE 8011-01-P


	SIP SUBMITTAL COMPLETENESS CRITERIA CHECKLIST

	(in accordance with 40 CFR Part 51 - App. V)

   SIP Submitted by:  Pennsylvania Department of Environmental Protection

     Date Submitted:   March 27, 2007

            Subject:         Redesignation of the Harrisburg, PA 8-hour Ozone Nonattainment Area to Attainment and Approval of the Area’s 		          Maintenance Plan

Completeness Review

Completed by:           Ellen Wentworth

     Date Completed:   April 10, 2007

Administrative Materials

	ACCEPTABLE

	EPA REQUIREMENT

	STATE SUBMITTAL

(X)

1. A formal letter of submittal from the Governor or his designee, requesting EPA approval of the plan or revision thereof.

1. Letter was submitted on March 27, 2007, on behalf of the Commonwealth of Pennsylvania from Kathleen McGinty, Secretary, PADEP to Donald S. Welsh, Regional Administrator, EPA Region III.

 X

2. Evidence that the State has adopted the plan in the State code or body of regulations; or issued the permit, order, consent agreement in final form.  That evidence shall include the date of adoption or final issuance as well as the effective date of the plan, if different from the adoption/issuance date.

2.  N/A   Not a regulatory change.  The submittal is a request for redesignation and a maintenance plan and a 2002 base-year inventory that is effective March 2007.

 X

3. Evidence that the State has the necessary legal authority under State law to adopt and implement the plan.

3.  State has legal authority to adopt this maintenance plan under Section 5 of the Air Pollution Control Act.

X

4. A copy of actual regulation, or document submitted for approval and incorporation by reference into the plan, including indication of the changes made to the existing approved plan, where applicable.  The submittal shall be a copy of the official State regulation/document signed, stamped, dated by the appropriate State official indicating that it is fully enforceable by the State.  The effective date of the regulation/document shall, whenever possible, be indicated in the document itself.

4.   See number 2 above.

X

5. Evidence that the State followed all of the procedural requirements of the State's laws and constitution in conducting and completing the adoption/issuance of the plan.

5.  N/A

 X

6. Evidence that public notice was given of the proposed change consistent with procedures approved by EPA, including the date of publication of such notice.

6. PADEP provided proof that the notice of public hearing was published in the Pennsylvania Bulletin on December 23, 2006.

 X

7. Certification that public hearings were held in accordance with the information provided in the public notice and the State's laws and constitution, if applicable.

7.  Notice of public hearing was given to the public in The Patriot News, Co. on December 22, 2006.

 X

8. Compilation of public comments and the State's response thereto.

8.  The state submittal includes a compilation of public comments and responses thereto.

 X

1. Identification of all regulated pollutants affected by the plan.

1.  8-Hour Ozone

 X

2. Identification of the locations of affected sources including the EPA attainment/nonattainment designation of the locations and the status of the attainment plan for the affected area(s).

2.  Applies to the Harrisburg Nonattainment Area which is comprised of the counties of Cumberland, Dauphin, Lebanon, and Perry counties.

 X

3. Quantification of the changes in plan allowable emissions from the affected sources; estimates of changes in current actual emissions from affected sources or, where appropriate, quantification of changes in actual emissions from affected sources through calculations of the differences between certain baseline levels and allowable emissions anticipated as a result of the revision.

3.  A 2002 base-year emissions inventory was submitted along with a maintenance plan as SIP revisions.  Attainment inventory and projected inventories submitted in the maintenance plan.

 X

4. The State's demonstration that the national ambient air quality standards, prevention of significant deterioration increments, reasonable further progress demonstration, and visibility, as applicable, are protected if the plan is approved and implemented.

4.  The state has developed a current and projected (2002, 2004, 2009, and 2018) emissions inventory showing attainment of the national ambient air quality standard (NAAQS).  This portion of the maintenance plan shows how the NAAQS will be protected since emission levels are expected to remain at or below the levels needed for attainment.

X

5. Modeling information required to support the proposed revision, including input data, output data, models used,  ambient monitoring data used, meteorological data used, justification for use of offsite data (where used), modes of models used, assumptions, and other information relevant to the determination of adequacy of the modeling analysis.

5.  All data and evidence is present for this action.

X

6. Evidence, where necessary, that emission limitations are based on continuous emission reduction technology.

6   N/A

X

7. Evidence that the plan contains emission limitations, work practice standards and recordkeeping/reporting requirements, where necessary, to ensure emission levels.

7.  Evidence is shown that PADEP will do periodic emission inventory updates and analysis.

X

8. Compliance/enforcement strategies, including how compliance will be determined in practice.

8  PADEP will continue to monitor ambient air in the Area, and to review the emissions inventory.  If an exceedance or growth in the emissions inventory occurs, contingency measures will be triggered.

X

9. Special economic and technological justifications required by any applicable EPA policies. (If a policy is not appropriate, explain why.)

9.  N/A

X

10. A Section 107 request must be accompanied by a maintenance plan demonstrating maintenance to the relevant NAAQS for at least 10 years after redesignation.

10.  The Maintenance Plan was submitted to EPA Region III on March 27, 2007.  This plan demonstrates maintenance for 2006-2018.

X


MEMORANDUM

DATE:		7/23/14

TO:		Clean Power Plan for Existing Power Plants; Docket Id: OAR - 2013-0602

FROM:	Michael Gordon, EPA Region 3

SUBJECT:	7/23/2014 Meeting with the Delaware Department of Natural Resources and Environmental Control Regarding Proposed Clean Power Plan for Existing Power Plants
--------------------------------------------------------------------------------

SUMMARY

      A conference call was held between EPA and the Delaware Department of Natural Resources and Environmental Control on July 23, 2014 to discuss the proposed Clean Power Plan for Existing Power Plants. The Clean Power Plan for Existing Power Plants was proposed on June 2, 2014.

ATTENDEES

Howard Hoffman, Office of General Counsel
Nathan Topham, Office of Air Quality Planning and Standards
Diana Esher, Air Protection Division
Pat Egan, Air Protection Division
Emily Linn, Air Protection Division
Mike Gordon, Air Protection Division
David Risley, Office of Atmospheric Programs
Bill Stevens, Office of Atmospheric Programs
Matt Clouse, Office of Atmospheric Programs
Chris Sherry, Office of Atmospheric Programs
Jim Ketcham-Colwill, Office of Policy Analysis and Review
Juan Santiago, Office of Air Quality Planning and Standards
David Solomon, Office of Air Quality Planning and Standards
Brian Fisher, Office of Atmospheric Programs
Joe Bryson, Office of Atmospheric Programs

Ali Mirzakhalili, DNREC
Ron Amirikian, DNREC
Valerie Gray, DNREC


[Federal Register: November 3, 2009 (Volume 74, Number 211)]
[Proposed Rules]
[Page 56748-56750]
[DOCID:fr03no09-19]

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

DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

14 CFR Part 39

[Docket No. FAA-2009-1025; Directorate Identifier 2009-CE-055-AD]
RIN 2120-AA64

Airworthiness Directives; Extra Flugzeugproduktions- und
Vertriebs-GmbH Models EA-300/200 and EA-300/L Airplanes

AGENCY: Federal Aviation Administration (FAA), Department of
Transportation (DOT).

ACTION: Notice of proposed rulemaking (NPRM).

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

SUMMARY: We propose to adopt a new airworthiness directive (AD) for the
products listed above. This proposed AD results from mandatory
continuing airworthiness information (MCAI) originated by an aviation
authority of another country to identify and correct

an unsafe condition on an aviation product. The MCAI describes the
unsafe condition as:

    The manufacturer has advised that the combination of a
redesigned tail spring support with a stiffer tail spring and rough
field operations has led to cracks in the tail spring support
mounting base. Cracks have also been reported on aeroplanes already
compliant with Part II of Extra Service Bulletin No. SB-300-2-97
issue A, as mandated by the LBA AD D-1998-001, dated 15 January
1998.

    The proposed AD would require actions that are intended to address
the unsafe condition described in the MCAI.

DATES: We must receive comments on this proposed AD by December 18,
2009.

ADDRESSES: You may send comments by any of the following methods:
     Federal eRulemaking Portal: Go to http://
www.regulations.gov. Follow the instructions for submitting comments.
     Fax:<PHONE_NUMBER>.
     Mail: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590.
     Hand Delivery: U.S. Department of Transportation, Docket
Operations, M-30, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue, SE., Washington, DC 20590, between 9 a.m. and 5 p.m.,
Monday through Friday, except Federal holidays.

Examining the AD Docket

    You may examine the AD docket on the Internet at http://
www.regulations.gov; or in person at the Docket Management Facility
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. The AD docket contains this proposed AD, the regulatory
evaluation, any comments received, and other information. The street
address for the Docket Office (telephone<PHONE_NUMBER>) is in the
ADDRESSES section. Comments will be available in the AD docket shortly
after receipt.

FOR FURTHER INFORMATION CONTACT: Greg Davison, Aerospace Engineer, FAA,
Small Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Comments Invited

    We invite you to send any written relevant data, views, or
arguments about this proposed AD. Send your comments to an address
listed under the ADDRESSES section. Include ``Docket No. FAA-2009-1025;
Directorate Identifier 2009-CE-055-AD'' at the beginning of your
comments. We specifically invite comments on the overall regulatory,
economic, environmental, and energy aspects of this proposed AD. We
will consider all comments received by the closing date and may amend
this proposed AD because of those comments.
    We will post all comments we receive, without change, to http://
www.regulations.gov, including any personal information you provide. We
will also post a report summarizing each substantive verbal contact we
receive about this proposed AD.

Discussion

    The European Aviation Safety Agency, which is the Technical Agent
for the Member States of the European Community, has issued AD No.:
2009-0160, July 21, 2009 (corrected on July 28, 2009) (referred to
after this as ``the MCAI''), to correct an unsafe condition for the
specified products. The MCAI states:

    The manufacturer has advised that the combination of a
redesigned tail spring support with a stiffer tail spring and rough
field operations has led to cracks in the tail spring support
mounting base. Cracks have also been reported on aeroplanes already
compliant with Part II of Extra Service Bulletin No. SB-300-2-97
issue A, as mandated by the LBA AD D-1998-001, dated 15 January
1998.
    For the reasons stated above, this new AD mandates instructions
for recurring inspections and modification in the area of the tail
spring support in order to prevent separation of the tail landing
gear which could result in serious damage to the airplane during
landing.

    You may obtain further information by examining the MCAI in the AD
docket.

Relevant Service Information

    Extra Flugzeugproduktions- und Vertriebs-GmbH has issued EXTRA
Service Bulletin No. SB-300-2-97, Issue: C, dated September 24, 2009.
The actions described in this service information are intended to
correct the unsafe condition identified in the MCAI.

FAA's Determination and Requirements of the Proposed AD

    This product has been approved by the aviation authority of another
country, and is approved for operation in the United States. Pursuant
to our bilateral agreement with this State of Design Authority, they
have notified us of the unsafe condition described in the MCAI and
service information referenced above. We are proposing this AD because
we evaluated all information and determined the unsafe condition exists
and is likely to exist or develop on other products of the same type
design.

Differences Between This Proposed AD and the MCAI or Service
Information

    We have reviewed the MCAI and related service information and, in
general, agree with their substance. But we might have found it
necessary to use different words from those in the MCAI to ensure the
AD is clear for U.S. operators and is enforceable. In making these
changes, we do not intend to differ substantively from the information
provided in the MCAI and related service information.
    We might also have proposed different actions in this AD from those
in the MCAI in order to follow FAA policies. Any such differences are
highlighted in a NOTE within the proposed AD.

Costs of Compliance

    We estimate that this proposed AD will affect 184 products of U.S.
registry. We also estimate that it would take about 2 work-hours per
product to comply with the basic requirements of this proposed AD. The
average labor rate is $80 per work-hour.
    Based on these figures, we estimate the cost of the proposed AD on
U.S. operators to be $29,440, or $160 per product.
    In addition, we estimate that any necessary follow-on actions would
take about 20 work-hours and require parts costing $460, for a cost of
$2,060 per product. We have no way of determining the number of
products that may need these actions.

Authority for This Rulemaking

    Title 49 of the United States Code specifies the FAA's authority to
issue rules on aviation safety. Subtitle I, section 106, describes the
authority of the FAA Administrator. ``Subtitle VII: Aviation
Programs,'' describes in more detail the scope of the Agency's
authority.
    We are issuing this rulemaking under the authority described in
``Subtitle VII, Part A, Subpart III, Section 44701: General
requirements.'' Under that section, Congress charges the FAA with
promoting safe flight of civil aircraft in air commerce by prescribing
regulations for practices, methods, and procedures the Administrator
finds necessary for safety in air commerce. This regulation is within
the scope of that authority because it addresses an unsafe condition
that is likely to exist or develop on products identified in this
rulemaking action.

Regulatory Findings

    We determined that this proposed AD would not have federalism
implications under Executive Order 13132. This proposed AD would not
have a substantial direct effect on the States, on the relationship
between the national Government and the States, or on the distribution
of power and responsibilities among the various levels of government.
    For the reasons discussed above, I certify this proposed
regulation:
    1. Is not a ``significant regulatory action'' under Executive Order
12866;
    2. Is not a ``significant rule'' under the DOT Regulatory Policies
and Procedures (44 FR 11034, February 26, 1979); and
    3. Will not have a significant economic impact, positive or
negative, on a substantial number of small entities under the criteria
of the Regulatory Flexibility Act.
    We prepared a regulatory evaluation of the estimated costs to
comply with this proposed AD and placed it in the AD docket.

List of Subjects in 14 CFR Part 39

    Air transportation, Aircraft, Aviation safety, Incorporation by
reference, Safety.

The Proposed Amendment

    Accordingly, under the authority delegated to me by the
Administrator, the FAA proposes to amend 14 CFR part 39 as follows:

PART 39--AIRWORTHINESS DIRECTIVES

    1. The authority citation for part 39 continues to read as follows:

    Authority:  49 U.S.C. 106(g), 40113, 44701.

Sec.  39.13  [Amended]

    2. The FAA amends Sec.  39.13 by adding the following new AD:

Extra Flugzeugproduktions- und Vertriebs-GmbH: Docket No. FAA-2009-
1025; Directorate Identifier 2009-CE-055-AD.

Comments Due Date

    (a) We must receive comments by December 18, 2009.

Affected ADs

    (b) None.

Applicability

    (c) This AD applies to the following model and serial number
airplanes, certificated in any category:
    (1) Model EA-300/200 airplanes, serial numbers (S/N) 01 through
31, and 1032 through 1043; and
    (2) Model EA-300/L airplanes, S/N 01 through 170, 172, 173,
1171, and 1174 through 1299.

Subject

    (d) Air Transport Association of America (ATA) Code 53:
Fuselage.

Reason

    (e) The mandatory continuing airworthiness information (MCAI)
states:
    ``The manufacturer has advised that the combination of a
redesigned tail spring support with a stiffer tail spring and rough
field operations has led to cracks in the tail spring support
mounting base. Cracks have also been reported on aeroplanes already
compliant with Part II of Extra Service Bulletin No. SB-300-2-97
issue A, as mandated by the LBA AD D-1998-001, dated 15 January
1998.
    ``For the reasons stated above, this new AD mandates
instructions for recurring inspections and modification in the area
of the tail spring support in order to prevent separation of the
tail landing gear which could result in serious damage to the
airplane during landing.''

Actions and Compliance

    (f) Unless already done, do the following actions:
    (1) Before further flight after the effective date of this AD
and repetitively thereafter at intervals not to exceed 50 hours
time-in-service, inspect the tail spring support for cracks in
accordance with PART I of Extra Flugzeugproduktions- und Vertriebs-
GmbH EXTRA Service Bulletin No. SB-300-2-97, Issue: C, dated
September 24, 2009.
    (2) If any crack is found as a result of the inspections
required by paragraph (f)(1) of this AD, before further flight,
modify the tail spring support structure as instructed in PART II of
Extra Flugzeugproduktions- und Vertriebs-GmbH EXTRA Service Bulletin
No. SB-300-2-97, Issue: C, dated September 24, 2009. Modification of
the tail spring support structure terminates the repetitive
inspections required in paragraph (f)(1) of this AD.
    (3) You may at any time modify the tail spring support structure
as instructed in PART II of Extra Flugzeugproduktions- und
Vertriebs-GmbH EXTRA Service Bulletin No. SB-300-2-97, Issue: C,
dated September 24, 2009, to terminate the repetitive inspections
required in paragraph (f)(1) of this AD.

FAA AD Differences

    Note: This AD differs from the MCAI and/or service information
as follows: No differences.

Other FAA AD Provisions

    (g) The following provisions also apply to this AD:
    (1) Alternative Methods of Compliance (AMOCs): The Manager,
Standards Office, FAA, has the authority to approve AMOCs for this
AD, if requested using the procedures found in 14 CFR 39.19. Send
information to ATTN: Greg Davison, Aerospace Engineer, FAA, Small
Airplane Directorate, 901 Locust, Room 301, Kansas City, Missouri
64106; telephone:<PHONE_NUMBER>; fax:<PHONE_NUMBER>. Before using
any approved AMOC on any airplane to which the AMOC applies, notify
your appropriate principal inspector (PI) in the FAA Flight
Standards District Office (FSDO), or lacking a PI, your local FSDO.
    (2) Airworthy Product: For any requirement in this AD to obtain
corrective actions from a manufacturer or other source, use these
actions if they are FAA-approved. Corrective actions are considered
FAA-approved if they are approved by the State of Design Authority
(or their delegated agent). You are required to assure the product
is airworthy before it is returned to service.
    (3) Reporting Requirements: For any reporting requirement in
this AD, under the provisions of the Paperwork Reduction Act (44
U.S.C. 3501 et seq.), the Office of Management and Budget (OMB) has
approved the information collection requirements and has assigned
OMB Control Number 2120-0056.

Related Information

    (h) Refer to MCAI European Aviation Safety Agency AD No.: 2009-
0160, July 21, 2009 (corrected on July 28, 2009); and Extra
Flugzeugproduktions- und Vertriebs-GmbH EXTRA Service Bulletin No.
SB-300-2-97, Issue: C, dated September 24, 2009, for related
information.

    Issued in Kansas City, Missouri, on October 28, 2009.
Margaret Kline,
Acting Manager, Small Airplane Directorate, Aircraft Certification
Service.
[FR Doc. E9-26391 Filed 11-2-09; 8:45 am]

BILLING CODE 4910-13-P


[Federal Register Volume 85, Number 48 (Wednesday, March 11, 2020)]
[Notices]
[Pages 14202-14203]
[FR Doc No: 2020-04994]

=======================================================================
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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2020-D-0420]

Providing Regulatory Submissions in Alternate Electronic Format;
Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Providing Regulatory Submissions in Alternate Electronic Format.''
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Congress
granted FDA the authority to implement the statutory electronic
submission requirements in guidance. In response, FDA implemented
binding guidance requiring that new drug applications (NDAs),
abbreviated new drug applications (ANDAs), certain drug master files
(DMFs), certain biologics license applications (BLAs), and certain
investigational new drug applications (INDs) be submitted to the Agency
in electronic common technical document (eCTD) format. Recognizing that
some submissions are exempt from this requirement and that waivers of
the requirement may be granted on a case-by-case basis, the Agency is
issuing this draft guidance to describe the alternate electronic format
sponsors or applicants should use for submissions covered under such
exemptions and waivers.

DATES: Submit either electronic or written comments on the draft
guidance by May 11, 2020 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final
version of the guidance.

ADDRESSES: You may submit comments on any guidance at any time as
follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
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 comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment 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): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, 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-2020-D-0420 for ``Providing Regulatory Submissions in Alternate
Electronic Format.'' Received comments will be placed in the docket
and, except for those submitted as ``Confidential Submissions,''
publicly viewable at https://www.regulations.gov or at the Dockets
Management Staff between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments 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 https://www.regulations.gov. Submit both copies to the Dockets Management
Staff. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.
    You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
    Submit written requests for single copies of the draft guidance to
the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10001 New Hampshire Ave.,
Hillandale Building, 4th Floor, Silver Spring, MD 20993-0002, or to the
Office of Communication, Outreach and Development, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 3128, Silver Spring, MD 20993-0002. Send
one self-addressed adhesive label to assist that office in processing
your requests. See the SUPPLEMENTARY INFORMATION section for electronic
access to the draft guidance document.

FOR FURTHER INFORMATION CONTACT: Dat Doan, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 51, Rm. 3334, Silver Spring, MD 20993-0002,<PHONE_NUMBER>; or
Stephen Ripley, Center for Biologics Evaluation and Research, Food and
Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301,
Silver Spring, MD 20993-0002,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Providing Regulatory Submissions in Alternate Electronic
Format.'' This draft guidance provides recommendations on an alternate
electronic format for submissions that are covered under an exemption
from or granted a waiver of the requirements of section 745A(a) of the
FD&C Act (21 U.S.C. 379k-1). These recommendations pertain to the
electronic format of content in NDAs, ANDAs, DMFs, certain BLAs, and
certain INDs submitted to the Center for Drug Evaluation and Research
or to the Center for Biologics Evaluation and Research.
    This draft guidance includes information on: (1) How to submit in
alternate electronic format (without xml backbone), (2) submission of
FDA forms, (3) pre-submission considerations, (4) submission structure,
(5) file formats and versions, (6) datasets and study information, (7)
transmitting electronic submissions, and (8) receipt dates.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on ``Providing
Regulatory Submissions in Alternate Electronic Format.'' It does not
establish any rights for any person and is not binding on FDA or the
public. You can use an alternative approach if it satisfies the
requirements of the applicable statutes and regulations.

II. Paperwork Reduction Act of 1995

    This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 312 have been approved under
OMB control number 0910-0014; the collections of information in 21 CFR
part 314 have been approved under OMB control number 0910-0001; and the
collections of information in 21 CFR part 601 have been approved under
OMB control number 0910-0338.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at https://www.fda.gov/drugs/guidance-compliance-regulatory-information/guidances-drugs, https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances, or https://www.regulations.gov.

    Dated: March 6, 2020.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2020-04994 Filed 3-10-20; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register: July 15, 2008 (Volume 73, Number 136)]
[Notices]
[Page 40592-40593]
[DOCID:fr15jy08-62]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Docket ID: FEMA-2007-0008]

National Advisory Council Meeting

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice of Federal Advisory Committee Meeting.

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

SUMMARY: This notice announces the date, time, location, and agenda for
the next meeting of the National Advisory Council (NAC). At the
meeting, the subcommittees will be reporting back regarding their work
since the May 14-15, 2008 meeting. This meeting will be open to the
public.

DATES: Meeting Dates: Wednesday, August 13, 2008, from approximately 11
a.m. to 5 p.m. and Thursday, August 14, 2008, 9 a.m. to 4:30 p.m. A
public comment period will take place on the afternoon of August 14,
2008, between approximately 2:30 p.m. and 3 p.m.
    Comment Date: Written comments or requests to make oral
presentations must be received by August 6, 2008.

ADDRESSES: The meeting will be held at the Grand Hyatt Washington, 1000
H St. NW., Washington, DC 20001. Persons wishing to make an oral
presentation, or who are unable to attend or speak at the meeting, may
submit written comments. Written comments and requests to make oral
presentations at the meeting should be provided to the address listed
in the FOR FURTHER INFORMATION CONTACT section and must be received by
August 6, 2008. All submissions received must include the Docket ID
FEMA-2007-0008 and may be submitted by any one of the following
methods:
    Federal Rulemaking Portal: http://www.regulations.gov. Follow
instructions for submitting comments on the Web site.
    E-mail<EMAIL_ADDRESS>Include Docket ID FEMA-2007-0008 in the
subject line of the message.
    Facsimile:<PHONE_NUMBER>.
    Mail: Office of Chief Counsel, Federal Emergency Management Agency,
Room 835, 500 C Street, SW., Washington, DC 20472.
    Hand Delivery/Courier: Office of the Chief Counsel, Federal
Emergency Management Agency, Room 835, 500 C Street, SW., Washington,
DC 20472.
    Instructions: All submissions received must include the Docket ID
FEMA-2007-0008. Comments received will also be posted without
alteration at http://www.regulations.gov, including any personal
information provided.
    Docket: For access to the docket to read background documents or
comments received by the National Advisory Council, go to http://
www.regulations.gov.

FOR FURTHER INFORMATION CONTACT: Alyson Price, Designated Federal
Officer, Federal Emergency Management Agency, 500 C Street, SW.,
Washington, DC 20472, telephone<PHONE_NUMBER>, fax<PHONE_NUMBER>, and e-
mail<EMAIL_ADDRESS>or<EMAIL_ADDRESS>The NAC's
Web site is located at: http://www.fema.gov/about/nac/.

SUPPLEMENTARY INFORMATION: Notice of this meeting is given under the
Federal Advisory Committee Act (FACA), Public Law 92-463, as amended (5
U.S.C. App. 1 et seq. ). The National Advisory Council (NAC) will meet
for the purpose of reviewing the progress of the NAC subcommittees, to
receive an update on

the Regional Advisory Councils, transition issues, and other matters.
    Public Attendance: The meeting is open to the public. Please note
that the meeting may close early, if all business is finished. Persons
with disabilities who require special assistance should advise the
Designated Federal Officer of their anticipated special needs as early
as possible. Members of the public who wish to make comments on
Thursday, August 14, 2008 between 2:30 p.m. and 3 p.m. are requested to
register in advance, and must be present and seated by 1:30 pm. In
order to allow as many people as possible to speak, speakers are
requested to limit their remarks to 3 minutes. For those wishing to
submit written comments, please follow the procedure noted above.

    Dated: July 7, 2008.
R. David Paulison,
Administrator, Federal Emergency Management Agency.
[FR Doc. E8-15978 Filed 7-14-08; 8:45 am]

BILLING CODE 9111-48-P