[Federal Register Volume 83, Number 238 (Wednesday, December 12, 2018)]
[Notices]
[Pages 63894-63896]
[FR Doc No: 2018-26855]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2015-D-4750]

The ``Deemed to be a License'' Provision of the BPCI Act:
Questions and Answers; Draft Guidance for Industry; Availability;
Request for Comments on Preliminary List of Affected Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability; request for comments.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry entitled ``The
`Deemed to be a License' Provision of the BPCI Act: Questions and
Answers.'' This draft guidance is intended to provide answers to common
questions about FDA's interpretation of the statutory provision under
which an application for a biological product approved under the
Federal Food, Drug, and Cosmetic Act (FD&C Act) as of March 23, 2020,
will be deemed to be a license for the biological product under the
Public Health Service Act (PHS Act) on March 23, 2020. This guidance
also describes FDA's compliance policy for the labeling of biological
products that will be the subject of deemed biologics license
applications (BLAs). This guidance is intended to facilitate planning
for the March 23, 2020, transition date and provide further clarity
regarding the Agency's interpretation of this statutory provision. FDA
also invites comment on the preliminary list of approved new drug
applications (NDAs) for biological products under the FD&C Act that
will be deemed to be BLAs on the transition date.

DATES: Submit either electronic or written comments on the draft
guidance by February 11, 2019 to ensure that the Agency considers your
comment on this draft guidance before it begins work on the final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-2015-D-4750 for ``The `Deemed to be a License' Provision of the
BPCI Act: Questions and Answers; Draft Guidance for Industry.''
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.gpo.gov/fdsys/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 this 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: Janice Weiner, Center for Drug
Evaluation and Research, Food and

Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6270,
Silver Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
or Stephen Ripley, Center for Biologics Evaluation and Research, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7268,
Silver Spring, MD 20993-0002,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``The `Deemed to be a License' Provision of the BPCI Act:
Questions and Answers.'' This draft guidance is intended to provide
answers to common questions about FDA's interpretation of the
``transition'' provision of the Biologics Price Competition and
Innovation Act of 2009 (BPCI Act) under which an application for a
biological product approved under section 505 of the FD&C Act (21
U.S.C. 355) as of March 23, 2020, will be deemed to be a license for
the biological product under section 351 of the PHS Act (42 U.S.C. 262)
on March 23, 2020 (``the transition date''). This guidance also
describes FDA's compliance policy for the labeling of biological
products that will be the subject of deemed BLAs. This guidance is
intended to facilitate planning for the transition date and provide
further clarity regarding the Agency's interpretation of this statutory
provision.
    Although the majority of therapeutic biological products have been
licensed under section 351 of the PHS Act, some protein products
historically have been approved under section 505 of the FD&C Act. On
March 23, 2010, the BPCI Act was enacted as part of the Patient
Protection and Affordable Care Act (Pub. L. 111-148). The BPCI Act
clarified the statutory authority under which certain protein products
will be regulated by amending the definition of a ``biological
product'' in section 351(i) of the PHS Act to include a ``protein
(except any chemically synthesized polypeptide),'' and describing
procedures for submission of a marketing application for certain
``biological products.'' FDA has previously stated its interpretation
of the statutory terms ``protein'' and ``chemically synthesized
polypeptide'' in the amended definition of ``biological product'' (see
FDA's draft guidance for industry entitled ``New and Revised Draft Q&As
on Biosimilar Development and the BPCI Act (Revision 2),'' available on
FDA's website at https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm.
Elsewhere in this issue of the Federal Register, FDA also has issued a
proposed rule to amend its regulation that defines ``biological
product'' to incorporate changes made by the BPCI Act, and to provide
its interpretation of the statutory terms ``protein'' and ``chemically
synthesized polypeptide.'' When final, this regulation will codify
FDA's interpretation of these terms.
    The BPCI Act requires that a marketing application for a
``biological product'' (that previously could have been submitted under
section 505 of the FD&C Act) must be submitted under section 351 of the
PHS Act; this requirement is subject to certain exceptions during a 10-
year transition period ending on March 23, 2020 (see section 7002(e)(1)
to (3) and (e)(5) of the BPCI Act). On March 23, 2020, an approved
application for a biological product under section 505 of the FD&C Act
shall be deemed to be a license for the biological product under
section 351 of the PHS Act (see section 7002(e)(4) of the BPCI Act).
    In the Federal Register of March 14, 2016 (81 FR 13373), FDA
announced the availability of a draft guidance on ``Implementation of
the `Deemed to be a License' Provision of the Biologics Price
Competition and Innovation Act of 2009'' (Transition Policy Draft
Guidance). In the Transition Policy Draft Guidance, FDA explains that
because the BPCI Act expressly provides that an application that is
approved on March 23, 2020, shall be deemed to be a license, FDA
interprets section 7002(e) of the BPCI Act to mean that the Agency will
not approve any application under section 505 of the FD&C Act for a
biological product subject to the transition provisions that is pending
or tentatively approved after March 23, 2020. Such an application may,
for example, be withdrawn and submitted under section 351(a) or 351(k)
of the PHS Act, as appropriate. FDA also provides recommendations to
minimize the impact on development programs for any proposed protein
products intended for submission under section 505 of the FD&C Act that
may not be able to receive final approval by March 23, 2020.
    FDA received several comments on the Transition Policy Draft
Guidance, including comments requesting that FDA provide additional
information on administrative procedures and regulatory issues that
would facilitate planning for the transition date. For example,
commenters requested additional information on FDA expectations with
respect to certain requirements for biological products regulated under
the PHS Act that differ from requirements for drug products regulated
under the FD&C Act. Commenters also requested information on FDA's
approach to certain procedural issues, such as: (1) The transition of
biological products from FDA's ``Approved Drug Products with
Therapeutic Equivalence Evaluations'' (the Orange Book) to FDA's
``Lists of Licensed Biological Products with Reference Product
Exclusivity and Biosimilarity or Interchangeability Evaluations'' (the
Purple Book); (2) whether an approved NDA will be deemed to be a
license under section 351(a) or 351(k) of the PHS Act; (3) how BLA
numbers will be assigned; and (4) user fee issues. This Q&A draft
guidance is intended to address these comments and provide additional
information to facilitate planning for the transition date.
    We invite comment on the Q&A draft guidance, including additional
topics that may be helpful for the Agency to address in connection with
the transition date. In particular, we invite comment on the compliance
policy for the labeling of biological products that are the subject of
deemed BLAs and the length of the compliance period. In addition, we
invite comment on the factors that FDA should consider in determining
whether a combination product composed of a biological product
constituent part and a drug constituent part will be subject to the
transition provision.
    We also invite comment on the preliminary list of approved
applications for biological products under the FD&C Act that will be
affected by the transition provision (available on FDA's website at
https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/default.htm). If an application holder or other person believes that an
approved NDA should be added to the list or should not be included on
the list, the application holder or other person should submit a
comment to the public docket established for this Q&A draft guidance
and the list.
    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 ``The `Deemed
to be a License' Provision of the BPCI Act: Questions and Answers.'' 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. This guidance is not subject to Executive Order 12866.

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
collection of information in 21 CFR part 314 has been approved under
OMB control number 0910-0001; the collection of information in 21 CFR
parts 601 and 610 has been approved under OMB control number 0910-0338;
the collection of information in 21 CFR 600.80 through 600.90 has been
approved under OMB control number 0910-0308; and the collection of
information in 21 CFR 201.56, 201.57, and 201.80 has been approved
under OMB control number 0910-0572. In addition, the collections of
information for applications submitted under section 351(k) of the PHS
Act (42 U.S.C. 262(k)) have been approved under OMB control number
0910-0719.

III. Electronic Access

    Persons with access to the internet may obtain the draft guidance
at either https://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or
https://www.regulations.gov.

    Dated: December 6, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-26855 Filed 12-11-18; 8:45 am]
 BILLING CODE 4164-01-P


[Federal Register Volume 77, Number 126 (Friday, June 29, 2012)]
[Notices]
[Page 38795]
[FR Doc No: 2012-15972]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. EL12-78-000]

Gerry E. Greenfield Jr. v. Benton County, WA; Notice of Petition
To Enforce PURPA

    Take notice that on June 21, 2012, pursuant to section 210(h) of
the Public Utility Regulatory Policies Act of 1978 (PURPA),\1\ Gerry E.
Greenfield Jr. filed a petition requesting that the Federal Energy
Regulatory Commission (Commission) initiate enforcement action against
Benton County, Washington, regarding the operation of a 25 KW Net
Metering Facility.
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    \1\ 16 U.S.C. 824a-3(h) (2006).
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    Any person desiring to intervene or to protest this filing must
file in accordance with Rules 211 and 214 of the Commission's Rules of
Practice and Procedure (18 CFR 385.211, 385.214). Protests will be
considered by the Commission in determining the appropriate action to
be taken, but will not serve to make protestants parties to the
proceeding. Any person wishing to become a party must file a notice of
intervention or motion to intervene, as appropriate. Such notices,
motions, or protests must be filed on or before the comment date. On or
before the comment date, it is not necessary to serve motions to
intervene or protests on persons other than the Applicant.
    The Commission encourages electronic submission of protests and
interventions in lieu of paper using the ``eFiling'' link at http://www.ferc.gov. Persons unable to file electronically should submit an
original and 14 copies of the protest or intervention to the Federal
Energy Regulatory Commission, 888 First Street NE., Washington, DC
20426.
    This filing is accessible on-line at http://www.ferc.gov, using the
``eLibrary'' link and is available for review in the Commission's
Public Reference Room in Washington, DC. There is an ``eSubscription''
link on the web site that enables subscribers to receive email
notification when a document is added to a subscribed docket(s). For
assistance with any FERC Online service, please email
<EMAIL_ADDRESS>or call<PHONE_NUMBER> (toll free). For
TTY, call<PHONE_NUMBER>.
    Comment Date: 5 p.m. Eastern Time on July 12, 2012.

    Dated: June 25, 2012.
Kimberly D. Bose,
Secretary.
[FR Doc. 2012-15972 Filed 6-28-12; 8:45 am]
BILLING CODE 6717-01-P


[Federal Register Volume 88, Number 108 (Tuesday, June 6, 2023)]
[Notices]
[Pages 37064-37065]
[FR Doc No: 2023-12043]

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ENVIRONMENTAL PROTECTION AGENCY

[FRL-10995-01-OA]

Public Meeting of the Science Advisory Board Environmental
Justice Screen (EJScreen) Review Panel

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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SUMMARY: The Environmental Protection Agency (EPA) Science Advisory
Board (SAB) Staff Office is announcing a

public meeting of the Science Advisory Board Environmental Justice
Screen (EJScreen) Review Panel. The purpose of the meeting is to
discuss the Panel's draft report on the EPA's EJScreen mapping and
screening tool.

DATES:
    Public meeting: The Science Advisory Board EJScreen Review Panel
will meet on June 22, 2023, from 11 a.m. to 3 p.m. Eastern Time.
    Comments: See the section titled ``Procedures for providing public
input'' under SUPPLEMENTARY INFORMATION for instructions and deadlines.

ADDRESSES: The June 22, 2023, meeting will be conducted virtually.
Please refer to the SAB website at https://sab.epa.gov for information
on how to attend the meeting.

FOR FURTHER INFORMATION CONTACT: Any member of the public who wants
further information concerning this document may contact Carolyn
Kilgore, Designated Federal Officer (DFO), via telephone (202) 564-
0230, or email at [email protected]. General information about
the SAB, as well as any updates concerning the meeting announced in
this document, can be found on the SAB website at https://sab.epa.gov.

SUPPLEMENTARY INFORMATION:
    Background: The SAB was established pursuant to the Environmental
Research, Development, and Demonstration Authorization Act (ERDDAA),
codified at 42 U.S.C. 4365, to provide independent scientific and
technical advice to the EPA Administrator on the scientific and
technical basis for agency positions and regulations. The SAB is a
Federal Advisory Committee chartered under the Federal Advisory
Committee Act (FACA), 5 U.S.C., app. 2. The SAB will comply with the
provisions of FACA and all appropriate SAB Staff Office procedural
policies. Pursuant to FACA and EPA policy, notice is hereby given that
the Science Advisory Board EJScreen Review Panel will hold a public
meeting to discuss the Panel's draft report on the EPA's EJScreen
mapping and screening tool.
    Availability of meeting materials: All meeting materials, including
the agenda, will be available on the SAB web page at https://sab.epa.gov.
    Procedures for providing public input: Public comment for
consideration by EPA's federal advisory committees and panels has a
different purpose from public comment provided to EPA program offices.
Therefore, the process for submitting comments to a federal advisory
committee is different from the process used to submit comments to an
EPA program office. Federal advisory committees and panels, including
scientific advisory committees, provide independent advice to the EPA.
Members of the public can submit relevant comments pertaining to the
committee's charge or meeting materials. Input from the public to the
SAB will have the most impact if it provides specific scientific or
technical information or analysis for the SAB to consider or if it
relates to the clarity or accuracy of the technical information.
Members of the public wishing to provide comment should follow the
instructions below to submit comments.
    Oral statements: In general, individuals or groups requesting an
oral presentation at a meeting conducted virtually will be limited to
three minutes. Each person making an oral statement should consider
providing written comments as well as their oral statement so that the
points presented orally can be expanded upon in writing. Persons
interested in providing oral statements should contact the DFO, in
writing (preferably via email) at the contact information noted above
in FOR FURTHER INFORMATION CONTACT, by June 19, 2023, to be placed on
the list of registered speakers.
    Written statements: Written statements will be accepted throughout
the advisory process; however, for timely consideration by SAB members,
statements should be submitted to the DFO by June 19, 2023, for
consideration at the June 22, 2023, meeting. Written statements should
be supplied to the DFO at the contact information above via email.
Submitters are requested to provide an unsigned version of each
document because the SAB Staff Office does not publish documents with
signatures on its website. Members of the public should be aware that
their personal contact information if included in any written comments,
may be posted to the SAB website. Copyrighted material will not be
posted without the explicit permission of the copyright holder.
    Accessibility: For information on access or services for
individuals with disabilities, please contact the DFO, at the contact
information noted above, preferably at least ten days prior to the
meeting, to give the EPA as much time as possible to process your
request.

V. Khanna Johnston,
Deputy Director, Science Advisory Board Staff Office.
[FR Doc. 2023-12043 Filed 6-5-23; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: August 4, 2008 (Volume 73, Number 150)]
[Notices]
[Page 45257-45258]
[DOCID:fr04au08-76]

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SECURITIES AND EXCHANGE COMMISSION

[Release Nos. 33-8947; 34-58236; File No. 4-564]

Roundtable on International Financial Reporting Standards

AGENCY: Securities and Exchange Commission.

ACTION: Notice of roundtable discussion; request for comment.

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SUMMARY: On August 4, 2008 from 1 p.m. to 5 p.m., the Securities and
Exchange Commission will hold a

roundtable to discuss International Financial Reporting Standards
(``IFRS'') and to update the Commission on IFRS developments, including
the experience with use of IFRS during the recent period of market
turmoil. The roundtable will be organized as two panels. The panels
will include investors, issuers, auditors, and other parties with
experience in IFRS reporting. Additionally, representatives from the
Financial Accounting Standards Board and the International Accounting
Standards Board will be present as observers.
    The roundtable will be held in the auditorium of SEC headquarters
at 100 F Street, NE., Washington, DC. The roundtable will be open to
the public with seating on a first-come, first-served basis. The
roundtable discussions also will be available via webcast on the SEC's
Web site at http://www.sec.gov. The roundtable agenda and other
materials related to the roundtable, including a list of participants
and moderators, will be accessible at http://www.sec.gov/spotlight/
ifrsroadmap.htm. The Commission welcomes feedback regarding any of the
topics to be addressed at the roundtable.

DATES: Comments should be received on or before August 11, 2008.

ADDRESSES: Comments may be submitted by any of the following methods:

Electronic Comments

     Use the Commission's Internet submission form (http://
www.sec.gov/rules/other.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File Number 4-564 on the subject line.

Paper Comments

     Send paper comments in triplicate to Florence Harmon,
Acting Secretary, Securities and Exchange Commission, 100 F Street,
NE., Washington, DC 20549-1090.
    All submissions should refer to File No. 4-564. This file number
should be included on the subject line if e-mail is used. To help us
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/other.shtml). Comments also
will be available for public inspection and copying in the Commission's
Public Reference Room, 100 F Street, NE., Washington, DC 20549, on
official business days between the hours of 10 a.m. and 3 p.m. All
comments received will be posted without change; we do not edit
personal identifying information from submissions. You should submit
only information that you wish to make available publicly.

FOR FURTHER INFORMATION CONTACT: Liza McAndrew Moberg, Professional
Accounting Fellow, at<PHONE_NUMBER>, Office of the Chief Accountant,
Securities and Exchange Commission, 100 F Street, NE., Washington, DC
20549-6561.

SUPPLEMENTARY INFORMATION: The Commission welcomes feedback regarding
any of the topics to be addressed at the roundtable. The panel
discussions will focus on:
     An update on IFRS developments
     Experience with the use of IFRS in practice, including
during the recent period of market turmoil, more specifically:
     Applying IFRS in the preparation of financial statements
     Working with financial statements prepared pursuant to
IFRS

    By the Commission.

    Dated: July 29, 2008.
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-17763 Filed 8-1-08; 8:45 am]

BILLING CODE 8010-01-P


PAPERWORK REDUCTION ACT SUBMISSION Please read the instructions before completing this form. For additional forms or assistance in completing this form, contact your agency's Paperwork Clearance Officer. Send two copies of this form, the collection instrument to be reviewed, the Supporting Statement and any additional documentation to: Office of Information and Regulatory Affairs, Office of Management and Budget, Docket Library, Room 10102, 725 17th Street NW Washington, DC 20503.

1. Agency/ Subagency originating request: US EPA, Office of Compliance, OECA, Agricultural and Ecosystem Division 2. OMB control number b. G None a__ 2 _ 0_ 6_ 0 _  0_ 0_ 3_ 2 _ __ __ __ __

3. Type of information collection ( check one) a. G New collection b. G Revision of a currently approved collection c. X Extension of a currently approved collection d. G Reinstatement, without change, of a previously approved collection for which approval has expired e. G Reinstatement, with change, of a previously approved collection for which approval has expired f. G Existing collection in use without an OMB control number 4. Type of review requested ( check one) a. X Regular b. G Emergency  Approval requested by: / / c. G Delegated 5. Small entities Will this information collection have a significant economic impact on a substantial number of small entities? G Yes X No For b f, note item A2 of Supporting Statement Instructions 6. Requested expiration date a. X Three years from approval date b. G Other Specify: / /___

7. Title NSPS for Ammonium Sulfate Manufacturing Plants, 40 CFR Part 60, Subpart PP 8. Agency form number( s) ( If applicable) 1066.03 9. Keywords Air Pollution Control, Clean Air Act, Environmental Protection 10. Abstract This regulation applies to each ammonium sulfate dryer within an ammonium sulfate manufacturing plant in the caprolactam, synthetic, and coke oven by products sectors of the ammonium sulfate manufacturing industry for which construction, modification or reconstruction commenced after the date of proposal. Owners and operators must conduct an initial performance test , and monitor and record control device operating parameters, and comply with a particulate emission standard.

11. Affected public ( Mark primary with " P" and all others that apply with " X") a. Individuals or households d. Farms b. P Business or other for profit e. Federal Government c. Not for profit institutions f. State, Local or Tribal Government 12. Obligation to respond ( Mark primary with " P" and all others that apply with " X") a. G Voluntary b. G Required to obtain or retain benefits c. P Mandatory 13. Annual reporting and recordkeeping hour burden a. Number of respondents 2 b. Total annual responses 2 1. Percentage of these responses collected electronically 0 % c. Total annual hours requested 182 d. Current OMB inventory 182 e. Difference 0 f. Explanation of difference 1. Program Change 2. Adjustment 14. Annual reporting and recordkeeping cost burden ( in thousands of dollars)

a. Total annualized capital/ startup costs 0 b. Total annual costs ( O& M) 0 c. Total annualized cost requested 0 d. Current OMB inventory 0 e. Difference f. Explanation of difference 1. Program change 2. Adjustment 15. Purpose of information collection ( Mark Primary With " P" and all others that apply with " X") a. __ Application for benefits e. __ Program planning or management b. __ Program evaluation f. __ Research c. __ General purpose statistics g. P _ Regulatory or compliance d. __ Audit 16. Frequency of recordkeeping or reporting ( check all that apply) a. X Recordkeeping b. Q Third party disclosure c. Q Reporting 1. Q On occasion 2. Q Weekly 3. Q Monthly 4. Q Quarterly 5. Q Semi annually 6. Q Annually 7. Q Biennually 8. Q Other ( describe)

17. Statistical methods Does this information collection employ statistical methods?

Q Yes X No 18. Agency contact ( person who can best answer questions regarding the content of this submission) Name: Stephen J. Howie Phone: 202 564 4146 OMB 83 I 10/ 95 19. Certification for Paperwork Reduction Act Submissions On behalf of this Federal agency, 1 certify that the collection of information encompassed by this request complies with' 5 CFR 1320.9.

NOTE: The text of 5 CFR 1320.9, and the related provisions of 5 CFR 1320.8( b)( 3), appear at the end of the instructions. The certification is to be made with reference to those regulatory provisions as set forth in the instructions.

The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:

( a) It is necessary for the proper performance of agency functions;

( b) It avoids unnecessary duplication;

( c) It reduces burden on small entities;

( d) It uses plain, coherent, and unambiguous terminology that is understandable to respondents;

( e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

( f) It indicates the retention periods for recordkeeping requirements;

( g) It informs respondents of the information called for under 5 CFR 1320.8( b)( 3): ( i) Why the information is being collected; ( ii) Use of information; ( iii) Burden estimate; ( iv) Nature of response ( voluntary, required for a benefit, or mandatory); ( v) Nature and extent of confidentiality; and ( vi) Need to display currently valid OMB control number;

( h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected ( see note in Item 19 of the instructions);

( i) It uses effective and efficient statistical survey methodology; and ( j) It makes appropriate use of information technology.

If you are unable to certify compliance with any of these provisions, identify the item below and explain the reason in Item 18 of the Supporting Statement.

( c) This collection activity does not affect small businesses ( i) This collection activity does not employ statistical methods Signature of Program Office Official Rick Colbert, Director Agricultural and Ecosystem Division Office of Compliance ( OECA) Date Signature of Senior Official or designee Oscar Morales, Director Collection Strategies Division Office of Environmental Information ( OEI) Date OMB 83 I 10/ 95 Certification Requirement for Paperwork Reduction Act Submissions 5 CFR 1320.9 reads " As part of the agency submission to OMB of a proposed collection of information, the agency ( through the head of the agency, the Senior Official or their designee) shall certify ( and provide a record supporting such certification) that the proposed collection of information

"( a) is necessary for the proper performance of the functions of the agency, including that the information to be collected will have practical utility;

"( b) is not unnecessarily duplicative of information otherwise reasonably accessible to the agency;

"( c) reduces to the extent practicable and appropriate the burden on persons who shall provide information to or for the agency, including with respect to small entities, as defined in the Regulatory Flexibility Act 5 U. S. C § 601( 6)), the use of such techniques as:

"( 1) establishing differing compliance or reporting requirements or timetables that take into account the resources available to those who are to respond; "( 2) the clarification, consolidation, or simplification of compliance and reporting requirements; or collection of information , or any part thereof; "( 3) an exemption from coverage of the collection of information, or any part thereof;

"( d) is written using plain, coherent, and unambiguous terminology and is understandable to those who are to respond;

"( e) is to be implemented in ways consistent and compatible, to the maximum extent practicable, with the existing reporting and recordkeeping practices of those who are to respond;

"( f) indicates for each recordkeeping requirement the length of time persons are required to maintain the records specified;

"( g) informs potential respondents of the information called for under § 1320.8( b)( 3); [ see below]

"( h) has been developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected, including the processing of the information in a manner which shall enhance, where appropriate, the utility of the information to agencies and the public;

"( i) uses effective and efficient statistical survey methodology appropriate to the purpose for which the information is to be collected; and "( j) to the maximum extent practicable, uses appropriate information technology to reduce burden and improve data quality, agency efficiency and responsiveness to the public."

NOTE: 5 CFR 1320.8( b)( 3) requires that each collection of information:

"( 3) informs and provides reasonable notice to the potential persons to whom the collection of information is addressed of: "( i) the reasons the information is planned to be and/ or has been collected; "( ii) the way such information is planned to be and/ or has been used to further the proper performance of the functions of the agency; "( iii) an estimate, to the extent practicable, of the average burden of the collection ( together with a request that the public direct to the agency any comments concerning the accuracy of this burden estimate and any suggestions for reducing this burden); "( iv) whether responses to the collection of information are voluntary, required to obtain or retain a benefit ( citing authority), or mandatory ( citing authority); "( v) the nature and extent of confidentiality to be provided, if any ( citing authority); and "( vi) the fact that any 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."

10/ 95


[Federal Register: December 18, 2008 (Volume 73, Number 244)]
[Notices]
[Page 77023]
[DOCID:fr18de08-56]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 13305-000]

Whitestone Power and Communications; Notice of Preliminary Permit
Application Accepted for Filing and Soliciting Comments, Motions To
Intervene, and Competing Applications

December 11, 2008.
    On October 20, 2008, Whitestone Power and Communications filed an
application, pursuant to section 4(f) of the Federal Power Act,
proposing to study the feasibility of the Microturbine Hydrokinetic
River-In-Stream Energy Conversion Power Project, located in the Tanana
River, within the Unorganized Borough, near Delta Junction, Alaska. The
project uses no dam or impoundment.
    The proposed project would consist of: (1) 1 hydrokinetic turbine
generating unit, with a total installed capacity of 25 kilowatts, (2) a
proposed 3000-foot-long, 12.47-kilovolt transmission line, and (3)
appurtenant facilities. The project is estimated to have an annual
generation of 65 megawatt-hours, which would be used by the applicant.
    Applicant Contact: Mr. Steven Selvaggio, Whitestone Community
Association, Whitestone Power and Communications, PO Box 1630, Delta
Junction, Alaska 99737, phone:<PHONE_NUMBER>.
    FERC Contact: Kelly T. Houff<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-
13305) in the docket number field to access the document. For
assistance, call toll-free 1-866-208-3372.

Kimberly D. Bose,
Secretary.
[FR Doc. E8-29986 Filed 12-17-08; 8:45 am]

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[Federal Register: January 24, 2007 (Volume 72, Number 15)]
[Notices]
[Page 3184-3185]
[DOCID:fr24ja07-94]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-55120; File No. SR-NYSE-2006-110]

Self-Regulatory Organizations; New York Stock Exchange LLC; Order
Approving a Proposed Rule Change Relating to Its Linkage Order Fee

 January 18, 2007.
    On December 6, 2006, the New York Stock Exchange LLC (``NYSE'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission''), pursuant to Section 19(b)(1) of the Securities
Exchange Act of 1934 (``Act'' or ``Exchange Act'') \1\ and Rule 19b-4
thereunder,\2\ a proposal to retroactively apply an increase in the fee
(``Linkage Order Fee'') it charges its member organizations in
connection with orders in equities executed in another market pursuant
to the Plan for the Purpose of Creating and Operating an Intermarket
Communications Linkage (``Linkage Plan''). The proposal was published
for comment in the Federal Register on December 15, 2006.\3\ The
Commission received no comments on the proposal. This order approves
the proposed rule change.
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    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 17 CFR 240.19b-4.
    \3\ See Securities Exchange Act Release No. 54912 (December 11,
2006), 71 FR 75601.
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    The Exchange proposes to retroactively apply, as of December 1,
2006, an increase from $0.00025 to $0.000275 per share in the Linkage
Order Fee it charges its member organizations in connection with orders
in equities executed in another market pursuant to the Linkage Plan.
This increase in the Linkage Order Fee became effective on Monday,
December 4, 2006, pursuant to a previous rule change submitted by the
Exchange.\4\ The Linkage Order Fee was increased to $0.000275 to set it
at the same level as the regular equity transaction fee, which was
increased to that level as of December 1, 2006.\5\ The current filing
simply applies the revised Linkage Order Fee to transactions that
occurred on December 1, 2006, which is the only business day with
respect to which the Linkage Order Fee and the regular equity
transaction fee were not harmonized by the previous filing. The
Exchange wishes to harmonize the Linkage Order Fee payable on

transactions executed through the Linkage on December 1, 2006, with the
regular equity transaction fee payable on that day because the
difference in the amount payable by customers would be immaterial, but
the Exchange would incur significant costs in identifying those
transactions which should be charged the lower fee rate.\6\
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    \4\ See Securities Exchange Act Release No. 54911 (December 11,
2006), 71 FR 75603 (December 15, 2006) (notice of filing and
immediate effectiveness of SR-NYSE-2006-108).
    \5\ See Exchange Act Release No. 54856 (December 1, 2006); 71 FR
71215 (December 8, 2006) (SR-NYSE-2006-106).
    \6\ The Exchange estimates that the difference in the amount of
Linkage Order Fees payable under the old rate as compared to the
proposed revised rate by customers for trades executed on December
1, 2006, would be less than $2,000.00. Telephone conversation
between John Carey, Assistant General Counsel, NYSE, and Nathan
Saunders, Special Counsel, Division of Market Regulation,
Commission, December 7, 2006.
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    The Commission finds that the proposed rule change is consistent
with the requirements of the Act and the rules and regulations
thereunder applicable to a national securities exchange \7\ and, in
particular, the requirements of Section 6(b) of the Act \8\ and the
rules and regulations thereunder. Specifically, the Commission finds
that the proposal to retroactively apply the increase in the Linkage
Order Fee is consistent with Section 6(b)(4) of the Act,\9\ which
requires the equitable allocation of reasonable dues, fees, and other
charges among Exchange members and other persons using Exchange
facilities.
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    \7\ In approving this proposed rule change, the Commission has
considered the proposed rule's impact on efficiency, competition,
and capital formation. See 15 U.S.C. 78c(f).
    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(4).
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    It is therefore ordered, pursuant to Section 19(b)(2) of the
Act,\10\ that the proposed rule change (File No. SR-NYSE-2006-110) be,
and it hereby is, approved.
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    \10\ Id.
    \11\ 17 CFR 200.30-3(a)(12).

    For the Commission, by the Division of Market Regulation,
pursuant to delegated authority.\11\
Florence E. Harmon,
Deputy Secretary.
 [FR Doc. E7-974 Filed 1-23-07; 8:45 am]

BILLING CODE 8011-01-P


[Federal Register: February 19, 2010 (Volume 75, Number 33)]
[Notices]
[Page 7466-7467]
[DOCID:fr19fe10-57]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. IC09-912-001]

Commission Information Collection Activities (FERC-912 \1\),
Supplemental Notice

February 3, 2010.
AGENCY: Federal Energy Regulatory Commission.
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    \1\ FERC-912 (``Cogeneration and Small Power Production, PURPA
Section 210(m) Regulations for Termination or Reinstatement of
Obligation to Purchase or Sell;'' OMB Control No. 1902-0237) covers
the reporting requirements in 18 CFR Part 292.

ACTION: Supplemental notice.

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SUMMARY: In compliance with the requirements of section 3507 of the
Paperwork Reduction Act of 1995, 44 U.S.C. 3507, the Federal Energy
Regulatory Commission (Commission or FERC) has submitted the FERC-912
\1\ to the Office of Management and Budget (OMB) for review of the
information collection requirements.

SUPPLEMENTARY INFORMATION: In response to the Commission's Notice in
Docket No. IC09-912-001 requesting public comment (74 FR 63743, 12/4/
2009), FERC and OMB received one

comment. The comment addresses the FERC-912 and relates to a pending
rulemaking in Docket No. RM09-23 (``Revisions to Form, Procedures, and
Criteria for Certification of Qualifying Facility Status for a Small
Power Production or Cogeneration Facility''). The comment was also
submitted in Docket No. RM09-23 and will be addressed in Docket No.
RM09-23.

FOR FURTHER INFORMATION: Ellen Brown may be reached by telephone at
(202) 502-8663, by fax at<PHONE_NUMBER>, and by e-mail at
<EMAIL_ADDRESS>
Kimberly D. Bose,
Secretary.
[FR Doc. 2010-3099 Filed 2-18-10; 8:45 am]
BILLING CODE 6717-01-P