[Federal Register Volume 86, Number 196 (Thursday, October 14, 2021)]
[Notices]
[Page 57181]
[FR Doc No: 2021-22422]

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DEPARTMENT OF HOMELAND SECURITY

Federal Emergency Management Agency

[Internal Agency Docket No. FEMA-4589-DR; Docket ID FEMA-2021-0001]

Idaho; Amendment No. 1 to Notice of a Major Disaster Declaration

AGENCY: Federal Emergency Management Agency, DHS.

ACTION: Notice.

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SUMMARY: This notice amends the notice of a major disaster declaration
for State of Idaho (FEMA-4589-DR), dated March 4, 2021, and related
determinations.

DATES: This change occurred on September 8, 2021.

FOR FURTHER INFORMATION CONTACT: Dean Webster, Office of Response and
Recovery, Federal Emergency Management Agency, 500 C Street SW,
Washington, DC 20472,<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION: The Federal Emergency Management Agency
(FEMA) hereby gives notice that pursuant to the authority vested in the
Administrator, under Executive Order 12148, as amended, Toney L.
Raines, of FEMA is appointed to act as the Federal Coordinating Officer
for this disaster.
    This action terminates the appointment of Thomas J. Dargan as
Federal Coordinating Officer for this disaster.

    The following Catalog of Federal Domestic Assistance Numbers
(CFDA) are to be used for reporting and drawing funds: 97.030,
Community Disaster Loans; 97.031, Cora Brown Fund; 97.032, Crisis
Counseling; 97.033, Disaster Legal Services; 97.034, Disaster
Unemployment Assistance (DUA); 97.046, Fire Management Assistance
Grant; 97.048, Disaster Housing Assistance to Individuals and
Households In Presidentially Declared Disaster Areas; 97.049,
Presidentially Declared Disaster Assistance--Disaster Housing
Operations for Individuals and Households; 97.050, Presidentially
Declared Disaster Assistance to Individuals and Households--Other
Needs; 97.036, Disaster Grants--Public Assistance (Presidentially
Declared Disasters); 97.039, Hazard Mitigation Grant.

Deanne Criswell,
Administrator, Federal Emergency Management Agency.
[FR Doc. 2021-22422 Filed 10-13-21; 8:45 am]
BILLING CODE 9111-23-P


[Federal Register: May 14, 2009 (Volume 74, Number 92)]
[Notices]
[Page 22785-22786]
[DOCID:fr14my09-83]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-59883; File No. SR-NYSEAmex-2009-16]

Self-Regulatory Organizations; Notice of Filing and Immediate
Effectiveness of Proposed Rule Change by NYSE Amex LLC Making Certain
Amendments to Its Price List

May 7, 2009.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(the ``Act'') \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that, on April 30, 2009, NYSE Amex LLC (``NYSE Amex'' or the
``Exchange'') filed with the Securities and Exchange Commission (the
``Commission'') the proposed rule change as described in Items I, II,
and III 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.
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    \1\ 15 U.S.C.78s(b)(1).
    \2\ 17 CFR 240.19b-4.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Exchange proposes to amend its price list to (i) clarify that
non-electronic agency transactions of less than 10,000 shares between
floor brokers in the crowd are not subject to any transaction fee, (ii)
clarify that brokers are charged a discounted fee of $0.0005 per share
for Discretionary e-Quotes and verbal agency interest when taking
liquidity from the Exchange, and (iii) to remove references to the
payment of rebates applicable to the period prior to the implementation
of the Capital Commitment Schedule that are no longer relevant. The
text of the proposed rule change is available at the Exchange, the
Commission's Public Reference Room, and www.nyse.com.

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 self-regulatory organization
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 those statements may be examined at
the places specified in Item IV below. The Exchange has prepared
summaries, set forth in sections A, B, and C below, of the most
significant parts of such statements.

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

1. Purpose
    The Exchange proposes to modify the 2009 NYSE Amex Price List to
clarify that non-electronic agency transactions of less than 10,000
shares between floor brokers in the crowd are not subject to any
transaction fee. The 2009 NYSE Amex Price List does not currently
reference any fee for these transactions and the Exchange treats them
the same as non-electronic agency transactions of more than 10,000
shares, which are free of charge. The amended 2009 NYSE Amex Price List
will state that any non-electronic agency transaction between brokers
in the crowd is free of charge, regardless of size.
    The current NYSE Amex price list does not state a fee policy with
respect to Discretionary e-Quotes and orders submitted by floor brokers
as verbal agency interest. The Exchange's current practice with respect
to such orders is to charge the floor broker $0.0005 per share or, in
the case of securities with a trading price of less than $1.00, the
lesser of (i) $0.0005 per share or (ii) 0.25% of the dollar value of
the transaction. The current NYSE Amex Price List does not state this
fee policy. The Exchange is amending its price list to specifically
state this policy.
    Footnote 5 in the current 2009 NYSE Amex Price List states that
Designated Market Makers receive rebates under several circumstances
when providing liquidity on non-displayed interest using the Capital
Commitment Schedule, or, prior to the implementation of the Capital
Commitment Schedule, using the following message activities: price
improvement, size improvement (PRIN FILL), matching away market quotes.
As the Capital Commitment Schedule has been implemented, the text
dealing with the payment of rebates in the period prior to its
implementation is no longer relevant and the Exchange proposes to
delete it.
    The subheading ``Transactions in Securities with a Per Share Price
Above $1.00'' is modified to clarify that it applies to all
transactions in securities with a price equal to or greater than $1.00.
It will now read as follows: ``Transactions in Securities with a Per
Share Price of $1.00 or more.''
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with the provisions of Section 6 of the Act,\3\ in general, and Section
6(b)(4) of the Act,\4\ in particular, in that it is designed to provide
for the equitable allocation of reasonable dues, fees, and other
charges among its members and other persons using its facilities.
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    \3\ 15 U.S.C. 78f(b).
    \4\ 15 U.S.C. 78f(b)(4).
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B. Self-Regulatory Organization's Statement on Burden on Competition

    The Exchange does not believe that the proposed rule change will
impose any burden on competition that is not necessary or appropriate
in furtherance of the purposes of the Act.

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

    No written comments were solicited or received with respect to the
proposed rule change.

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

    The foregoing rule change is effective upon filing pursuant to
Section 19(b)(3)(A) \5\ of the Act and subparagraph (f)(2) of Rule 19b-
4 \6\ thereunder, because it establishes a due, fee, or other charge
imposed by NYSE Amex.
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    \5\ 15 U.S.C. 78s(b)(3)(A).
    \6\ 17 CFR 240.19b-4(f)(2).
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    At any time within 60 days of the filing of the proposed rule
change, the Commission may summarily abrogate such rule change if it
appears to the Commission that such action is necessary or appropriate
in the public interest, for the protection of investors, or otherwise
in furtherance of the purposes of the Act.

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-NYSEAmex-2009-16 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-NYSEAmex-2009-16. This
file number should be included on the subject line if e-mail 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 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. Copies of such 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 publicly available. All
submissions should refer to File Number SR-NYSEAmex-2009-16 and should
be submitted on or before June 4, 2009.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\7\
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    \7\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Deputy Secretary.
[FR Doc. E9-11227 Filed 5-13-09; 8:45 am]

BILLING CODE 8010-01-P


UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES January 6, 2005 MEMORANDUM SUBJECT: Review of materials submitted by Pioneer in support of proposed amendments to the Section G Experimental Use Permit ( EUP No: 029964 EUP 5, DP# 310099) for Cry34/ 35Ab1 corn. Submission dated July 28, 2004 and revised December 22, 2004.

TO: Michael Mendelsohn Senior Regulatory Action Leader Microbial Pesticides Branch, Biopesticides and Pollution Prevention Division ( 7511C)

FROM: Tessa Milofsky, M. S. Agronomist Microbial Pesticides Branch, Biopesticides and Pollution Prevention Division ( 7511C)

PEER REVIEW: Alan Reynolds, M. S. Entomologist Microbial Pesticides Branch, Biopesticides and Pollution Prevention Division ( 7511C)

CONCLUSION This request to extend the duration and increase the acreage of the existing Cry34/ 35 EUP is acceptable. It is recommended that 5,115 EUP acres should be granted ( 6,665 acres requested).

RECOMMENDATIONS   The registrant requested 100 acres for demonstration trials. However, section 5 of FIFRA states, " the Administrator may issue an experimental use permit only if the Administrator determines that the applicant needs such permit in order to accumulate information necessary to register a pesticide " Since demonstration trials do not provide information required for pesticide registration, inclusion of demonstration trials in EUP acreage is inappropriate. It is recommended that EUP acreage should not be granted for demonstration trials. 2   Based on available information, it is recommended that 2,500 EUP acres ( 3,950 acres requested) should be granted for insect resistance management trials. This acreage is agronomically justified, because the protocol includes a variety of trials, of which the largest may require as many as 500 acres per location.

  Proposed acreages for Cry34/ 35Ab1 corn breeding and observation nurseries, agronomic observation trials, herbicide tolerance studies, efficacy trials, nontarget organism studies, regulatory experiments, research seed production, and inbred seed increase are acceptable. However, it is recommended that all protocol descriptions should be expanded for future submissions.

  The participant/ collaborator information is sufficient provided that collaborator names and contact information are submitted prior to experiment initiation.

  The final Section G submission addressed most deficiencies identified by the Agency. However, state by state breakdowns of acreage and locations needed per protocol were not included. It is recommended that these details should be provided in the final report.

BACKGROUND This is a request to extend the duration and increase the allowable acreage permitted under the EUP granted for Pioneer's Cry34/ 35Ab11 corn, which protects against western corn rootworm ( WCRW; D. virgifera virgifera), northern corn rootworm ( NCRW; D. berberi), and Mexican corn rootworm ( D. virgifera zea). The EUP also includes acreage for stacked events, containing Cry34/ 35Ab1 and Cry1F insecticidal proteins, which provide combined protection against corn rootworm and lepidopteran pests. The present EUP ( last amended April 29, 2004) permits test plant cultivation on 4,690 acres in 27 states and Puerto Rico and is slated to expire April 30, 2005. Cry34Ab1 and Cry35Ab1 proteins are temporarily exempted ( exemption will expire April 30, 2006) from the requirement of a tolerance when used as plant incorporated protectants in the food and feed commodities of field corn, sweet corn, and popcorn ( CFR 2004, § 180.1242). Consequently, non crop destruct status has been granted, meaning that confinement and destruction of plant material ( e. g. pollen, seeds, stalks, etc.) is not required. It should be noted, however, that a Scientific Advisory Panel is scheduled to meet on March 1 2, 2005 " to consider and review human health issues associated with the Cry34Ab1 protein".

PROGRAM REVIEW The submission requests that the present EUP be extended until April 30, 2006, so that the registrant can " fully evaluate this product and its benefits." The registrant also requests that the allowable acreage be increased to 6,665 acres for the 2005 growing 1 The EUP covers corn containing the Cry34/ 35Ab1 Insecticidal Crystal Protein ( ICP) produced by construct ( event DAS 59122 7, plasmid insert PHP17662) and could include corn produced by traditional breeding of the rootworm protected corn with lepidopteran protected Bt corn ( e. g. Herculex 1 Corn ( Bt Cry1F, event 1507). 3 season. The attached EUP spreadsheet ( Appendix A) describes the proposed acreages for each state. It should be noted that the product's temporary exemption from tolerance expires April 30, 2006 and thus, corresponds with the proposed expiration date of the existing EUP.

Participant/ Collaborator Information The names, telephone numbers, and mailing addresses of participants who will supervise experimental work covered under this EUP are provided in the submission. Information on cooperators was not included, yet the registrant states that this listing will be provided prior to planting or initiation of the research trials.

BPPD Review Participant/ collaborator information is sufficient provided that undisclosed collaborator names and contact information are submitted prior to experiment initiation.

Acreage Calculation Total EUP acreage is equivalent to the sum of the acreage comprised in each EUP test block. This calculation would include all Cry34/ 35 corn plants ( includes stacked plants), non Cry34/ 35 corn plants ( e. g. breeding plants or isoline control plots), and associated border rows contained within the perimeter of the test block. The section also includes field plans that illustrate how blocks of EUP corn may be positioned in relation to non EUP corn fields, providing a visual representation of experimental block location.

BPPD Review This approach to EUP acreage calculation is acceptable.

Field Trial Containment/ Disposition Procedures Field trial containment is said to comply with the USDA APHIS performance standards for regulated corn trials. Six approaches to gene flow containment are listed ( e. g. bagging, 660 ft. isolation, temporal isolation, etc.), of which one or more will be used in the proposed trials.

Sections covering plant sampling, harvest procedures, final disposition, and volunteer plant monitoring, include brief ( from one to several sentences) descriptions of containment procedures that may be implemented during these phases.

BPPD Review The isolation methods presented are acceptable.

Specific Trial Protocols Specific trial protocols implemented for the period March 2004 March 2005 and proposed for the period March 2005 April 2006 are listed below. Two tables are presented for 2005 2006, because the initial request ( submitted 7 28 04) was replaced by a revised submission dated 12 22 04. It should be noted that the revised Section G was submitted in response the Agency's request for a breakdown of acreage per protocol, 4 followed by a request for more information on the insect resistance management protocol.

March 2004 April 2005 EUP Acres EUP Protocols Requested Granted Breeding and observation nursery ? ? Agronomic observation trials ? ? Herbicide tolerance study ? ? Efficacy trial ? ? Insect resistance management studies ? ? Non target organism studies ? ? Regulatory studies ? ? Research seed production ? ? Inbred seed increase ? ? Demonstration trials ? ? Total 9,050 4,690 March 2004 April 2005 Requested ( 7 28 04) EUP Protocols EUP Acres Lbs. of Seed Breeding and observation nursery ? ? Agronomic observation trials ? ? Herbicide tolerance study ? ? Efficacy trial ? ? Insect resistance management studies ? ? Non target organism studies ? ? Regulatory studies ? ? Research seed production ? ? Inbred seed increase ? ? Demonstration trials ? ? Total 13,050 217,543 March 2005 April 2006 Requested ( 12 22 04) EUP Protocols EUP Acres Lbs. of Seed Breeding and observation nursery 515 8,583 Agronomic observation trials 750 12,500 Herbicide tolerance study 100 1,667 Efficacy trial 100 1,667 Insect resistance management studies 3,950 65,834 Non target organism studies 100 1,667 Regulatory studies 150 2,500 Research seed production 100 1,667 Inbred seed increase 800 13,333 Demonstration trials 100 1,667 Total 6,665 111,084 5 Protocol descriptions include general information on the objective, experimental design, plot treatments, genotypes and vectors, and estimated planting and harvest schedules for each trial. Protocol objectives are listed below:

Protocol: Breeding and observation nursery Objective: Convert maize lines to contain the Bt Cry34/ 35Ab1 genes.

Protocol: Agronomic observation trials Objective: Assess the agronomic and phenotypic properties of Bt Cry34/ 35Ab1 maize lines.

Protocol: Herbicide tolerance studies Objective: Evaluate the effect of herbicide applications on Bt Cry34/ 35Ab1 maize lines.

Protocol: Efficacy trials Objective: Assess the efficacy of Bt Cry34/ 35Ab1 maize lines in controlling western corn rootworm, northern corn rootworm, Mexican corn rootworm and/ or other coleopteran insects Protocol: Insect resistance management studies Objective: Studies will provide information for the refinement of IRM strategies for Bt Cry34/ 35Ab1 maize lines.

Protocol: Non target organism studies Objective: Provide information on the effect of Bt Cry34/ 35Ab1 plants on non target arthropod populations commonly found in maize fields.

Protocol: Regulatory studies Objective: To produce grain and plant material for composition and expression analyses, product characterization, herbicide residue analysis, further regulatory or stewardship studies, and/ or benefit studies. Often these studies are done under GLP and are submitted to domestic or international regulatory agencies.

Protocol: Research seed production Objective: To produce seed for use in research and/ or regulatory testing.

Protocol: Inbred seed increase Objective: Increase inbred seed for further testing and product development.

Protocol: Demonstration trials Objective: Demonstrate the efficacy of Bt Cry34/ 35Ab1 maize plants in controlling western corn rootworm, northern corn rootworm, Mexican corn rootworm and/ or other coleopteran pests. 6 In preparation for the 2005 growing season, the registrant requested that EUP acreage be increased from the 4,690 acres granted in 2004, to 6,665 acres for 2005. Since a breakdown of acreage per protocol was not provided in the 2004 and initial 2005 EUP submissions, it is unclear which protocols are affected by the 1,975 acre increase and which were reduced in the revised 2005 submission. Consequently, useful year by year and submission by submission comparisons can not be made.

Requested acreage for individual protocols ( revised 2005 submission) are generally in line with past EUP acreage requests for insect protected corn products. However, the acreage for insect resistance management studies is considerably larger than that requested and granted for most EUPs. Consequently, the Agency recommended that a more detailed protocol description should be submitted for this study area. Information requested by the Agency included: descriptions of specific experimental protocols, experimental objectives and expected outcomes for each trial, experimental design, number of hybrids to be used, number of locations required, acreage per location, and a table showing required acreage and number of experimental locations per state.

The revised Section G, dated December 22, 2004, provided additional information on experiments that would be included within the insect resistance management protocol. Brief descriptions of these trials are listed below.

1. Monitoring large acreages of Cry34/ 35 inbreds for corn rootworm larval injury. Large scale testing ( 50 to 550 acres per location) is important because evaluations will rely on natural pest populations, which vary considerably throughout a field and from location to location.

Multiple replicate trials will examine three to five different Cry34/ 35 inbreds, with several different genetic backgrounds ( number of hybrids tested is subject to change). Rows of corn plants containing the Cry34/ 35 protein ( inbreds and hybrids) will alternate with rows containing non Cry34/ 35 corn ( e. g. row 1 = Cry34/ 35 corn, row 2 = non Cry34/ 35 corn, etc.)

Following peak larval feeding, plants from the non Cry34/ 35 rows will be inspected for root lodging. If root lodging for the non Cry34/ 35 line reaches a certain threshold, researchers will dig up roots from a representative sample of Cry34/ 35 and non Cry34/ 35 plants. Roots will be washed to remove soil and the level of rootworm damage will be visually scored.

Data generated from these experiments will be used to improve scientific understanding of trait performance ( corn rootworm protection), as well as performance correlations between inbred parent lines and hybrid crosses. Ultimately, this information would be used to set thresholds for trait performance, an important component in the development of unexpected damage guidelines.

2. Investigations of rootworm population dynamics in Cry34/ 35 fields. Research will be conducted to improve understandings of how Cry34/ 35 corn may 7 influence the number of emerging rootworm adults, the timing of adult emergence, gender ratios, dry weight of newly emerged adults, and root injury.

3. Cry34/ 35 dose studies. These investigations will provide insight into target pest adaptation to Cry34/ 35, by identifying the expected level of mortality inflicted by the insecticidal protein on rootworm larvae.

4. Cry34/ 35 efficacy studies. This research will improve the registrant's ability to establish reliable unexpected damage guidelines for rootworm resistance monitoring.

BPPD Review Present Submission Proposed acreages for Cry34/ 35Ab1 corn breeding and observation nurseries, agronomic observation trials, herbicide tolerance studies, efficacy trials, non target organism studies, regulatory experiments, research seed production, and inbred seed increase are acceptable. However, it is recommended that future submissions should include more detailed discussions of all protocols ( see Future Submissions section below).

The registrant has requested 100 acres for demonstration trials. However, section 5 of FIFRA states, " the Administrator may issue an experimental use permit only if the Administrator determines that the applicant needs such permit in order to accumulate information necessary to register a pesticide " Since demonstration trials do not provide information required for pesticide registration, inclusion of demonstration trials in EUP acreage is inappropriate. It is recommended that EUP acreage should not be granted for demonstration trials.

The registrant's original submission ( July 2004) did not include sufficient justification for the unusually large ( most PIP EUP submissions request 100 acres or less for this protocol) acreage request associated with insect resistance management trials. However, following the Agency's request, the registrant submitted supplemental information ( revised submission) which addressed the majority of identified deficiencies. Available information is sufficient to recommend acreage for the 2005 season, however it is recommended that outstanding deficiencies should be addressed in the final report ( see Final Report section below).

Based on available information, it is recommended that 2,500 EUP acres ( 3,950 acres requested) should be granted for insect resistance management trials. This acreage is agronomically justified because the protocol includes a variety of trials, the largest ( monitoring experiment) requiring 50 to 500 acres per location if useful results are to be gathered.

March 2004 April 2005 EUP Acres EUP Protocols Requested Agronomically Justified Breeding and observation nursery 515 515 8 Agronomic observation trials 750 750 Herbicide tolerance study 100 100 Efficacy trial 100 100 Insect resistance management studies 3,950 2,500 Non target organism studies 100 100 Regulatory studies 150 150 Research seed production 100 100 Inbred seed increase 800 800 Demonstration trials 100 0 Total Acreage 6,665 5,115 Final Report The final Section G submission addressed most deficiencies identified by the Agency. However, state by state breakdowns of acreage and locations needed per protocol were not included. Consequently, it is recommended that these details should be provided in the final report. Specifically, the final report should include:   A state by state breakdown of acreage per protocol.   A state by state breakdown of locations per protocol.   A listing of experiments conducted within each protocol.   Average acreage per location for each experiment included within each protocol ( ideally this would be presented on a state by state basis).

Future Submissions If EUP requests are to be objectively evaluated, it is strongly recommended that future submissions should include the following information:   Protocols to be conducted.   Experiments to be included within each protocol.   Estimated state by state breakdown of acreage per protocol.   Estimated state by state breakdown of locations per protocol.   Estimate of acreage and locations required for each experiment included within protocols ( ideally this would be presented on a state by state basis).   If an acreage increase is requested for one or more protocols, justification should be provided for those increases ( justification should be provided on a protocol by protocol basis).   Objective and brief description of each experiment included within protocols. Approximate number of hybrids/ inbreds/ isolines to be tested should also be included ( may be presented as average number of lines per location).   Clear explanation of acreage calculation, including a breakdown of EUP acreage designated for test plants, non test plants, and border rows included within experimental blocks.   It should be noted that EUP acreage designated for demonstration trials is generally considered inappropriate.


[Federal Register Volume 76, Number 225 (Tuesday, November 22, 2011)]
[Notices]
[Page 72236]
[FR Doc No: 2011-30091]

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DEPARTMENT OF TRANSPORTATION

Federal Aviation Administration

Agency Information Collection Activities: Requests for Comments;
Clearance of Renewed Approval of Information Collection: Financial
Responsibility Requirements for Licensed Reentry Activities

AGENCY: Federal Aviation Administration (FAA), DOT.

ACTION: Notice and request for comments.

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SUMMARY: In accordance with the Paperwork Reduction Act of 1995, FAA
invites public comments about our intention to request the Office of
Management and Budget (OMB) approval to renew an information
collection. The information collected supports FAA in determining the
amount of required liability insurance for a reentry operator after
examining the risk associated with a reentry vehicle, its operational
capabilities, and its designated reentry site.

DATES: Written comments should be submitted by January 23, 2012.

FOR FURTHER INFORMATION CONTACT: Kathy DePaepe at<PHONE_NUMBER>, or by
email at<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:
    OMB Control Number: 2120-0649.
    Title: Financial Responsibility Requirements for Licensed Reentry
Activities.
    Form Numbers: There are no FAA forms associated with this
collection.
    Type of Review: Renewal of an information collection.
    Background: This collection is applicable upon concurrence of
requests for conducting commercial reentry operations as prescribed in
14 CFR, Parts 400, et al., Commercial Space Transportation Reusable
Launch Vehicle and Reentry Licensing Regulation. A commercial space
launch services provider must complete the Reusable Launch Vehicle and
Reentry Licensing Regulation in order to gain authorization for
conducting reentry activities. The information collection requirement
enables FAA/AST to determine the amount of required liability insurance
for a reentry operator after examining the risks associated with a
reentry vehicle, its operational capabilities, and its designated
reentry site.
    Respondents: Approximately 1 reentry operator.
    Frequency: Information is collected on occasion.
    Estimated Average Burden per Response: 300 hours.
    Estimated Total Annual Burden: 300 hours.

ADDRESSES: Send comments to the FAA at the following address: Ms. Kathy
DePaepe, Room 126B, Federal Aviation Administration, AES-200, 6500 S.
MacArthur Blvd., Oklahoma City, OK 73169.
    Public Comments Invited: You are asked to comment on any aspect of
this information collection, including (a) Whether the proposed
collection of information is necessary for FAA's performance; (b) the
accuracy of the estimated burden; (c) ways for FAA to enhance the
quality, utility and clarity of the information collection; and (d)
ways that the burden could be minimized without reducing the quality of
the collected information. The agency will summarize and/or include
your comments in the request for OMB's clearance of this information
collection.

    Issued in Washington, DC, on November 14, 2011.
Albert R. Spence,
FAA Assistant Information Collection Clearance Officer, IT Enterprises
Business Services Division, AES-200.
[FR Doc. 2011-30091 Filed 11-21-11; 8:45 am]
BILLING CODE 4910-13-P


[Federal Register: July 10, 2008 (Volume 73, Number 133)]
[Notices]
[Page 39704-39705]
[DOCID:fr10jy08-68]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0381]

Draft Guidance for Industry on Voluntary Third-Party
Certification Programs for Foods and Feeds; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance for industry entitled ``Voluntary
Third-Party Certification Programs for Foods and Feeds.'' This draft
guidance describes the general attributes FDA believes a voluntary
third-party certification program should have in order to help ensure
its certification is a reliable reflection that the foods and feeds
from certified establishments are safe and meet applicable FDA
requirements.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit written or electronic comments on the draft guidance
by September 8, 2008.

ADDRESSES: Submit written comments on the draft guidance to the
Division of Dockets Management (HFA-305), Food and Drug Administration,
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic
comments to http://www.regulations.gov. See the SUPPLEMENTARY
INFORMATION section for electronic access to the draft guidance
document.

FOR FURTHER INFORMATION CONTACT:  Sharon Lindan Mayl, Food and Drug
Administration, 5600 Fishers Lane (HF-11), Rockville, MD 20857, 301-
827-3360.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a draft guidance for industry
entitled ``Voluntary Third-Party Certification Programs for Foods and
Feeds.'' This draft guidance is issued in response to the
recommendations contained in the Action Plan for Import Safety: A
Roadmap for Continual Improvement (Action Plan) issued on November 6,
2007, by the Interagency Working Group on Import Safety (Working Group)
established by Executive Order 13439, as well as FDA's Food Protection
Plan released on the same date. Both those plans emphasize
certification as a way to help verify the safety of products from a
growing food establishment inventory, both domestic and foreign.
    In the Federal Register of April 2, 2008 (73 FR 17989), FDA issued
a notice requesting comments on the use of third-party certification
programs for foods and animal feeds. FDA received approximately 70
comments in response to that notice. The comments were generally
supportive of the use of third-party certification programs. Many
encouraged FDA to recognize such programs as a way to increase
participation and improve the safety and security of foods.
    This draft guidance, when finalized, will represent FDA's current
thinking on the certification process and will describe the general
attributes FDA believes a voluntary third-party certification program
should have in order to provide FDA with confidence in that program. If
FDA has such confidence, we may choose to recognize the program and
provide incentives for establishments to obtain certification by
recognized certification programs. Recognition in this context means
that FDA has determined that certification may be a reliable reflection
that the foods from the certified establishment are safe and meet
applicable FDA requirements. Such recognition would be tailored to
particular categories of products and would occur in a separate
document that builds upon the general attributes set forth in this
document. Therefore, this draft guidance is intended as one of the
steps in FDA's future recognition of one or more voluntary third-party
certification programs for particular product types.
    To further that process, FDA is also announcing, in a separate
notice issued in this Federal Register, a voluntary pilot program for
third-party certification bodies that certify foreign processors of
aquacultured shrimp. This pilot is intended to gather technical and
operational information that will assist

FDA in determining its infrastructure needs, as well as the process for
evaluating third-party certification programs. The criteria for
selection for that pilot are based upon the attributes set forth in the
draft guidance.
    As with the pilot, the 12 attributes discussed in the draft
guidance are intended to provide a model that could be tailored for
particular categories of products and incorporated by FDA as it
recognizes third-party certification programs for those products. These
attributes incorporate such things as the authority of the
certification body to adequately inspect the establishments seeking
certification, qualifications, and training for the third-party
inspectors, self-assessment of the certification programs and its
inspectors, elements of an effective inspection program, notification
to FDA, and preventing conflicts of interest. While FDA invites
comments on all aspects of the draft guidance, FDA is particularly
interested in receiving comments on this list of attributes for the
certification program. More specifically, we would like to know whether
there are some attributes that should be removed or added and whether
the draft guidance provides sufficient information about each
attribute. We are also interested in knowing how this list compares
with existing, well-accepted guidelines or requirements for
certification programs.
    The draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent FDA's current thinking on Voluntary Third-
Party Certification Programs for Foods and Feeds. It does not create or
confer any rights for or on any person and does not operate to bind FDA
or the public. An alternative approach may be used if such approach
satisfies the requirements of the applicable statutes and regulations.

II. Comments

    The draft guidance is being distributed for comment purposes only
and is not intended for implementation at this time. Interested persons
may submit to the Division of Dockets Management (see ADDRESSES)
written or electronic comments regarding the draft guidance. Submit a
single copy of electronic comments or two paper copies of any mailed
comments, except that individuals may submit one paper copy. Comments
are to be identified with the docket number found in the brackets in
the heading of this document. A copy of the draft guidance and received
comments are available for public examination in the Division of
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Division of Dockets
Management Web site transitioned to the Federal Dockets Management
System (FDMS). FDMS is a Government-wide, electronic docket management
system. Electronic comments or submissions will be accepted by FDA only
through FDMS at http://www.regulations.gov.

III. Electronic Access

    Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/oc/guidance/thirdpartycert.html or http://
www.regulations.gov.

    Dated: July 7, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E8-15715 Filed 7-9-08; 8:45 am]

BILLING CODE 4160-01-S


[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49820-49821]
[FR Doc No: 2022-17385]

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

ENVIRONMENTAL PROTECTION AGENCY

[EPA-HQ-OW-2008-0150; FRL-10140-01-OMS]

Information Collection Request Submitted to OMB for Review and
Approval; Comment Request; Establishing No-Discharge Zones (NDZs) Under
Clean Water Act Section 312 (Renewal)

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice.

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

SUMMARY: The Environmental Protection Agency (EPA) has submitted an
information collection request (ICR), Establishing No-Discharge Zones
(NDZs) under Clean Water Act Section 312 (EPA ICR number 1791.09, OMB
Control Number 2040-0187) to the Office of Management and Budget (OMB)
for review and approval in accordance with the Paperwork Reduction Act.
This is a proposed extension of the ICR that is currently approved
through August 31, 2022. Public comments were previously requested via
the Federal Register on January 25, 2022, during a 60-day comment
period. This notice allows for an additional 30 days for public
comments. A description of the ICR is given below, including its
estimated burden and cost to the public. 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.

DATES: Additional comments may be submitted on or before September 12,
2022.

ADDRESSES: Submit your comments, referencing Docket ID Number EPA-HQ-
OW-2008-0150, online using www.regulations.gov (our preferred method),
by email to [email protected], or by mail to: EPA Docket Center,
Environmental Protection Agency, Mail Code 28221T, 1200 Pennsylvania
Ave. NW, Washington, DC 20460.
    For additional delivery options and information about EPA's
dockets, visit https://www.epa.gov/dockets. EPA's policy is that all
comments received will be included in the public docket without change
including any personal information provided, unless the comment
includes profanity, threats, information claimed to be Confidential
Business Information (CBI), or other information whose disclosure is
restricted by statute.
    Submit written comments and recommendations to OMB for the proposed
information collection within 30 days of publication of this notice to
www.reginfo.gov/public/do/PRAMain. Find this particular information
collection by selecting ``Currently under 30-day Review--Open for
Public Comments'' or by using the search function.

FOR FURTHER INFORMATION CONTACT: Kelsey Watts-FitzGerald, Oceans,
Wetlands, and Communities Division, Office of Wetlands, Oceans, and
Watersheds, 4504T, Environmental Protection Agency, 1200 Pennsylvania
Ave. NW, Washington, DC 20460; telephone number:<PHONE_NUMBER>; email
address: [email protected].

SUPPLEMENTARY INFORMATION: Supporting documents, which explain in
detail the information that the EPA will be collecting, are available
in the public docket for this ICR. The docket can be viewed online at
www.regulations.gov or in person at the EPA Docket Center, WJC West,
Room 3334, 1301 Constitution Ave. NW, Washington, DC. The telephone
number for the Docket Center is<PHONE_NUMBER>. For additional
information about EPA's public docket, visit http://www.epa.gov/dockets.
    Abstract: (A) Sewage No-Discharge Zones (NDZs): CWA section 312(f)
and the implementing regulations in 40 CFR part 140 identify the
information that must be included in a state's application to the EPA
to establish an NDZ for vessel sewage for some or all the state's
waters.
    In designated NDZs, discharge of both treated and untreated sewage
from vessels is prohibited. A state is not required to designate an NDZ
and therefore need only develop applications for waters where such a
discharge prohibition has been deemed necessary and beneficial by the
state. This ICR addresses the burden to state respondents to develop
applications containing the necessary information, as well as the
burden associated with the EPA's review of state applications. The
information collection activities discussed in this ICR do not require
the submission of any confidential information.
    (B) Uniform National Discharge Standards (UNDS) NDZs and Review of
Discharge Determination or Standard: CWA section 312(n)(7) and the
implementing regulations in 40 CFR part 1700 identify the information
that a state must submit to the EPA in the state's application to
establish an NDZ for one or more discharges incidental to the normal
operation of a vessel of the Armed Forces. A state may seek an NDZ
designation for any incidental discharge subject to UNDS for which the
EPA and Department of Defense (DoD) have promulgated national standards
of performance and corresponding implementing regulations,
respectively. In addition, CWA section 312(n)(5) provides that that the
Governor of any state may petition the EPA and DoD to review any
discharge determination or standard promulgated under CWA section
312(n) for vessels of the Armed Forces if there is significant new
information that could reasonably result in a change to the discharge
determination or standard. This ICR addresses the burden to a state
respondent to develop applications for NDZs and requests for a review
of a

determination or standard and the burden to the EPA to review the
applications. The information collection activities discussed in this
ICR do not require the submission of any confidential information.
    Form Numbers: None.
    Respondents/affected entities: States.
    Respondent's obligation to respond: The responses to this
collection of information are required to obtain the benefit of a
vessel sewage NDZ (CWA section 312(f)) or an UNDS NDZ or review of a
discharge determination or standard (CWA section 312(n)).
    Estimated number of respondents: 11 (total).
    Frequency of response: One time.
    Total estimated burden: 577 hours (per year). Burden is defined at
5 CFR 1320.03(b)
    Total estimated cost: $34,713 (per year), includes $548 annualized
capital or operation & maintenance costs.
    Changes in the Estimates: There is a decrease of 337 hours in the
total estimated respondent burden compared with the ICR currently
approved by OMB. This estimated decrease is attributable to a downward
adjustment in the estimated number of anticipated total actions during
the upcoming 3-year period.

Courtney Kerwin,
Director, Regulatory Support Division.
[FR Doc. 2022-17385 Filed 8-11-22; 8:45 am]
BILLING CODE 6560-50-P


01
2,790
1
.
7
17
1
1
.
7
2,611
1
.
8
1
,883
1
.
4
6
4
2
3
.
9
20
02
2,681
1
.
7
17
3
1
.
5
2,502
1
.
7
1
,825
1
.
4
5
9
5
3
.
5
20
03
2,606
1
.
6
16
8
1
.
4
2,430
1
.
6
1
,758
1
.
7
5
8
0
3
.
0
SOURCE: NATIONAL CENTER FOR HEALTH STATISTICS, FINAL MORTALITY STATISTICS REPORT, 1999-2003
NOTES:
(1) NUMBER OF DEATHS ARE CODED BY THE 10TH REVISION OF THE INTERNATIONAL CLASSIFICATION OF DISEASES, J45-J46.
(2) RATES ARE AGE-ADJUSTED TO THE 2000 U.S. STANDARD POPULATION.
(3) INCLUDES RACES OTHER THAN WHITE AND BLACK.
TABLE 3: ASTHMA-NUMBER OF DEATHS AND AGE-ADJUSTED DEATH RATE PER 100,000 POPULATION BY ORIGIN
NON-HISPANIC BLACK
TOTAL
HISPANIC
NON-HISPANIC (3)
NON-HISPANIC WHITE

YEAR
TOTAL
<1
1
-
4
5
-
1
4
15-
24
25-
34
35-
44
4
5
-
5
4
5
5
-
64
65
-
7
4
75-
8
4
85
+
STATE
D
1
979
(1)
2
,598
5
1
9
3
9
9
9
1
1
1
1
5
7
2
8
2
5
0
2
6
9
5
4
9
9
1
9
0
---
1
9
8
0
2
,891
8
2
1
6
1
1
0
5
1
3
0
1
4
5
3
0
9
5
2
9
7
6
5
5
9
6
2
2
2
---
1
9
8
1
3
,054
3
1
2
7
2
1
1
2
1
5
5
1
7
8
3
0
8
6
0
7
8
0
3
5
7
5
2
2
9
---
1
9
8
2
3
,154
8
2
6
7
0
1
6
2
1
6
9
1
7
6
3
4
1
5
8
2
7
9
3
5
9
3
2
3
4
---
1
9
8
3
3
,561
5
2
8
7
8
1
4
4
1
8
6
2
3
1
3
8
4
6
8
6
8
3
6
6
9
3
2
9
0
---
1
984
3,564
1
0
1
7
79
1
3
2
1
5
9
22
7
355
674
905
7
0
2
3
03
1
1
9
8
5
3
,880
6
2
1
9
8
1
5
6
1
8
2
2
3
1
3
7
8
7
5
5
9
3
6
7
8
5
3
3
2
---
1
9
8
6
3
,955
1
3
1
7
9
2
1
6
6
1
9
7
2
5
1
3
5
6
6
8
8
9
8
2
8
4
3
3
5
0
---
1
987
4,360
4
1
9
101
1
8
1
1
9
9
34
1
443
709
1,081
8
7
3
4
08
1
1
9
8
8
4
,597
7
1
9
9
3
1
6
2
2
3
1
3
4
3
4
4
0
7
8
5
1
,097
9
9
1
4
2
9
---
1
989
4,869
6
2
6
9
5
1
48
25
6
3
4
6
472
743
1,208
1,094
4
7
3
2
1
990
4,819
1
2
2
4
102
1
6
0
2
3
7
33
2
502
738
1,125
1,074
5
1
2
1
1
9
9
1
5
,106
5
3
0
1
0
6
1
8
3
2
8
0
3
8
6
5
1
0
7
3
7
1
,155
1
,161
5
5
3
---
1
9
9
2
4
,964
9
3
8
8
8
1
6
8
2
3
2
3
7
3
4
9
5
6
9
2
1
,164
1
,097
6
0
8
---
1
993
5,167


[Federal Register Volume 76, Number 71 (Wednesday, April 13, 2011)]
[Notices]
[Pages 20779-20780]
[FR Doc No: 2011-8801]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-64247; File No. SR-OCC-2011-04]

Self-Regulatory Organizations; The Options Clearing Corporation;
Notice of Filing and Immediate Effectiveness of Proposed Rule Change To
Provide Legal Certainty for the Trading of Futures on the CBOE Gold ETF
Volatility Index

April 7, 2011.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''),\1\ notice is hereby given that on March 25, 2011, The
Options Clearing Corporation (``OCC'') filed with the Securities and
Exchange Commission (``Commission'') the proposed rule change described
in Items I, II, and III below, which Items have been prepared primarily
by OCC. OCC filed the proposal pursuant to Section 19(b)(3)(A)(i) of
the Act \2\ and Rule 19b-4(f)(1) \3\ thereunder so that the proposal
was effective upon filing with the Commission. The Commission is
publishing this notice to solicit comments on the rule change from
interested parties.
---------------------------------------------------------------------------

    \1\ 15 U.S.C. 78s(b)(1).
    \2\ 15 U.S.C. 78s(b)(3)(A)(i).
    \3\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

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

    The proposed rule change will provide legal certainty for the
trading of futures on the CBOE Gold ETF Volatility Index (``GVZ
Index'').

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

    In its filing with the Commission, OCC 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. OCC has prepared summaries, set forth in sections (A),
(B), and (C) below, of the most significant aspects of these
statements.\4\
---------------------------------------------------------------------------

    \4\ The Commission has modified the text of the summaries
prepared by OCC.
---------------------------------------------------------------------------

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

    The purpose of this proposed rule change is to make clear that OCC
will clear futures on the GVZ Index as security futures. OCC is
proposing to add an interpretation to Article XII, Section 1 of OCC's
By-Laws.
    The GVZ Index is described by the CBOE Futures Exchange, LLC
(``CFE'') as an up-to-the-minute market estimate of the expected
volatility of SPDR Gold Shares (``GLD'') calculated by using real-time
bid/ask quotes of Chicago Board Options Exchange, Incorporated listed
GLD options.\5\ CFE states that the GVZ Index uses nearby and second
nearby options with at least 8 days left to expiration and then weights
them to yield a constant, 30-day measure of the expected (implied)
volatility.
---------------------------------------------------------------------------

    \5\ Securities Exchange Act Release No. 34-64152 (March 30,
2011).
---------------------------------------------------------------------------

    In its capacity as a ``derivatives clearing organization''
registered as such with the Commodity Futures Trading Commission
(``CFTC''), OCC is concurrently submitting this rule filing to the CFTC
pursuant to the self-certification procedures of CFTC Regulation 40.6.
    OCC believes that the proposed rule change and interpretation of
OCC's By-Laws is consistent with the requirements of Section 17A of the
Act \6\

and the rules and regulations thereunder applicable to OCC because it
is designed to promote the prompt and accurate clearance and settlement
of transactions in security futures, to foster cooperation and
coordination with persons engaged in the clearance and settlement of
such transactions, to remove impediments to and perfect the mechanism
of a national system for the prompt and accurate clearance and
settlement of such transactions, and, in general, to protect investors
and the public interest. It accomplishes this purpose by clarifying the
jurisdiction under, and capacity in which, OCC clears futures on the
GVZ Index. The proposed rule change is not inconsistent with the By-
Laws and Rules of OCC.
---------------------------------------------------------------------------

    \6\ 15 U.S.C. 78q-1.
---------------------------------------------------------------------------

(B) Self-Regulatory Organization's Statement on Burden on Competition

    OCC does not believe that the proposed rule change will have any
impact or impose any burden on competition.

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

    Written comments relating to the proposed rule change have not been
solicited or received. OCC will notify the Commission of any written
comments received by OCC.

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

    The foregoing proposed rule change has become effective upon filing
pursuant to Section 19(b)(3)(A)(i) of the Act \7\ and Rule 19b-4(f)(1)
\8\ thereunder because the proposed rule change constitutes a stated
policy, practice, or interpretation with respect to the meaning,
administration, or enforcement of an existing rule. At any time within
60 days of the filing of the proposed rule change, the Commission
summarily may temporarily suspend such rule change if it appears to the
Commission that such action is necessary or appropriate in the public
interest, for the protection of investors, or otherwise in furtherance
of the purposes of the Act.
---------------------------------------------------------------------------

    \7\ 15 U.S.C. 78s(b)(3)(A)(i).
    \8\ 17 CFR 240.19b-4(f)(1).
---------------------------------------------------------------------------

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 e-mail to<EMAIL_ADDRESS>Please include
File Number SR-OCC-2011-04 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-OCC-2011-04. This file
number should be included on the subject line if e-mail 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
a.m. and 3 p.m. Copies of such filings also will be available for
inspection and copying at the principal office of OCC and on OCC's Web
site at http://www.optionsclearing.com/components/docs/legal/rules_and_bylaws/sr_occ_11_04.pdf.
    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-OCC-2011-04
and should be submitted on or before May 4, 2011.
---------------------------------------------------------------------------

    \9\ 17 CFR 200.30-3(a)(12).

    For the Commission by the Division of Trading and Markets,
pursuant to delegated authority.\9\
Cathy H. Ahn,
Deputy Secretary.
[FR Doc. 2011-8801 Filed 4-12-11; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 77, Number 17 (Thursday, January 26, 2012)]
[Notices]
[Pages 4077-4079]
[FR Doc No: 2012-1583]

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

SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-66208; File No. SR-Phlx-2012-06]

Self-Regulatory Organizations; NASDAQ OMX PHLX LLC; Notice of
Filing and Immediate Effectiveness of Proposed Rule Change Amending the
Real-Time Risk Management Fee and Other Clarifying Amendments

January 20, 2012.
    Pursuant to Section 19(b)(1) of the Securities Exchange Act of 1934
(``Act''), \1\ and Rule 19b-4 thereunder,\2\ notice is hereby given
that on January 10, 2012, NASDAQ OMX PHLX LLC (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``SEC'' or ``Commission'') the proposed rule change as described in
Items I, II, and III below, which Items have been prepared by the
Exchange. 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 amend the Real-Time Risk Management Fee to
further clarify the application of the Fee. The Exchange also proposes
to relocate the FLEX and Cabinet Options Transaction Fees within
Section II of the Exchange's Fee Schedule and add clarifying text.
    The text of the proposed rule change is available on the Exchange's
Web site at http://nasdaqtrader.com/micro.aspx?id=PHLXfilings, 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 Exchange 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 the
Statutory Basis for, the Proposed Rule Change

1. Purpose
    The Exchange proposes to memorialize the Exchange's practice of
limiting the assessment of the Real-time Risk Management Fee to two (2)
ports. The Exchange also proposes to add language to clarify the types
of ports that are subject to this fee.
    The Exchange initially filed to adopt a real-time, trade
information fee (Real-time Risk Management Fee) for members receiving
option trading information on-line (i.e., electronically) from the
Exchange.\3\ The purpose of the fee was to provide members and member
organizations with option trade information electronically on a real-
time basis. Members and member organizations were able to log on to an
interface with AUTOM to receive options (among other information)
transaction information real-time. When adopted, the Exchange limited
the assessment of the Real-Time Risk Management Fee to two ports.\4\
The Exchange has not assessed any member or member organization in
excess of two

ports since this Fee was adopted in 2000.\5\ The Exchange proposes to
memorialize this practice in its Fee Schedule. The port may be either a
Specialized Quote Feed (``SQF'') \6\ Port or a Clearing Trade Interface
(``CTI'') \7\ Port. The member/member organization is assessed up to
two ports. The Exchange proposes to add the following language to the
Fee Schedule: ``$.003 per contract for members and member organizations
receiving information on a real-time basis up to a maximum of two
ports, which may be either an SQF Port or a CTI Port'' (new language in
bold), to memorialize its current practice.
---------------------------------------------------------------------------

    \3\ See Securities Exchange Act Release No. 43719 (December 13,
2000), 65 FR 80975 (December 22, 2000) (SR-Phlx-00-97). The Exchange
initially assessed $.0025 per contract and later raised this fee to
$.003 per contract. See also Securities Exchange Act Release No.
61685 (March 10, 2010), 75 FR 13187 (March 18, 2010) (SR-Phlx-2010-
39).
    \4\ See Securities Exchange Act Release No. 43719 (December 13,
2000), 65 FR 80975 (December 22, 2000) (SR-Phlx-00-97). The
information included symbol, volume, price, time and clearing
information.
    \5\ It was always the intent of the Exchange to limit this Fee
to two ports, although the initial filing does not state this
limitation, this has always been the practice of the Exchange.
    \6\ SQF is an interface that allows specialists, streaming quote
traders and remote streaming quote traders to connect and send
quotes into Phlx XL. SQF 6.0 allows participants to access
information in a single feed available to all participants, rather
than through accessing multiple feeds. The information available
includes execution reports and other relevant data. Non quoting
firms may also receive relevant information available over SQF by
connecting to the SQF interface, but they may not send quotes. The
set of data offered over this data feed is administrative in nature
or is used to attract liquidity to the Exchange in response to an
auction. Participants who write interfaces to the Phlx system use
the administrative data to determine the current state of the
trading system. For example, this data displays which symbols are
trading on the Phlx, the current state of an options symbol (i.e.,
open for trading, trading, halted or closed from trading), as well
as similar information regarding complex order strategies. This
administrative data also includes the definition of complex order
strategies. See Securities Exchange Act Release No. 63034 (October
4, 2010), 75 FR 62441 (October 8, 2010) (SR-Phlx-2010-124).
    \7\ CTI provides Exchange members with real-time clearing trade
updates. The updates include the members clearing trade messages on
a low latency, real-time basis. The trade messages are routed to a
member's connection containing certain information. The information
includes, among other things, the following: (i) The Clearing Member
Trade Agreement or ``CMTA'' or The Options Clearing Corporation or
``OCC'' number; (ii) Exchange badge or house number; and (iii) the
Exchange internal firm identifier. The administrative and market
event messages include, but are not limited to: System event
messages to communicate operational-related events; options
directory messages to relay basic option symbol and contract
information for options traded on the Exchange; complex strategy
messages to relay information for those strategies traded on the
Exchange; and trading action messages to inform market participants
when a specific option or strategy is halted or released for trading
on the Exchange. The information related to complex order strategy
messages includes information that lists the legs and the leg
ratios, which uniquely defines this strategy for an underlying. In
addition, the interface contains an indicator which distinguishes
electronic and non-electronic delivered orders. This information
will be available to members on a real-time basis. See Securities
Exchange Act Release No. 62155 (May 24, 2010), 75 FR 30081 (May 28,
2010) (SR-Phlx-2010-67).
---------------------------------------------------------------------------

    The Exchange also proposes to relocate the FLEX \8\ and Cabinet \9\
Options transaction fees within Section II of the Fee Schedule,
entitled ``Equity Option Fees,'' and add additional text to clarify
that the transaction fees for FLEX \10\ and Cabinet \11\ Options are
not in addition to the Options Transaction Charges. The Exchange also
proposes to include text concerning the waiver of facilitation orders,
currently in Section II in another part of Section II which addresses
other facilitation waivers. The Exchange believes that relocating this
text and adding a sentence which states ``Cabinet and FLEX Option Fees
above are not in addition to the Options Transaction Charges'' will add
more clarity to the Fee Schedule.
---------------------------------------------------------------------------

    \8\ A FLEX option is a customized option that provides parties
to the transaction with the ability to fix terms including the
exercise style, expiration date, and certain exercise prices. See
Exchange Rule 1079. FLEX Options are a trademark of the Chicago
Board Options Exchange.
    \9\ An ``accommodation'' or ``cabinet'' trade refers to trades
in listed options on the Exchange that are worthless or not actively
traded. Cabinet trading is generally conducted in accordance with
Exchange Rules, except as provided in Exchange Rule 1059 entitled
``Accommodation Trading'', which sets forth specific procedures for
engaging in cabinet trading below $ 1 per option contract. Cabinet
or accommodation trading of option contracts is intended to
accommodate persons wishing to effect closing transactions in those
series of options dealt in on the Exchange for which there is no
auction market.
    \10\ FLEX transaction fees are $0.10 per contract side for all
participants, except Customers. Specifically, the Exchange assess a
$.10 transaction charge on Professionals, Specialists, Registered
Options Traders, Streaming Quote Traders, Remote Streaming Quote
Traders, Broker-Dealers and Firms. Customers are not assessed a
transaction charge for FLEX Options. See Securities Exchange Act
Release No. 62379 (June 25, 2010), 75 FR 38163 (July 1, 2010) (SR-
Phlx-2010-87).
    \11\ Cabinet transaction fees are $ 0.10 per contract side for
all participants, except Customers. Specifically, the Exchange
assess a $.10 transaction charge on Professionals, Specialists,
Registered Options Traders, Streaming Quote Traders, Remote
Streaming Quote Traders, Broker-Dealers and Firms. Customers are not
assessed a transaction charge for Cabinet Options. See Securities
Exchange Act Release No. 65740 (November 18, 2011), 76 FR 72744
(November 25, 2011) (SR-Phlx-2011-150).
---------------------------------------------------------------------------

2. Statutory Basis
    The Exchange believes that its proposal to amend its Fee Schedule
is consistent with Section 6(b) of the Act \12\ in general, and
furthers the objectives of Section 6(b)(4) of the Act \13\ in
particular, in that it is an equitable allocation of reasonable fees
and other charges among Exchange members.
---------------------------------------------------------------------------

    \12\ 15 U.S.C. 78f(b).
    \13\ 15 U.S.C. 78f(b)(4).
---------------------------------------------------------------------------

    The Exchange believes that amending the Fee Schedule to memorialize
the Exchange's practice of not assessing the Real-time Risk Management
Fee on more than two ports is reasonable because this practice will be
clearly stated on the Fee Schedule. Also, the Exchange believes that it
is reasonable to clearly note the types of ports that are subject to
this Fee. The Exchange also believes that this amendment is equitable
and not unfairly discriminatory because the Exchange is uniformly
assessing the Real-time Risk Management Fee on all members and member
organizations. Every member or member organization will not be assessed
the Real-time Risk Management Fee in excess of two ports, either an SQF
Port or a CTI Port.
    The Exchange believes that its proposal to relocate the Cabinet and
FLEX Options section within Section II of the Fee Schedule and add more
clarity concerning the assessment of these fees is reasonable,
equitable and not unfairly discriminatory because the amendments will
further clarify the application of Section II fees. The proposed
amendments are not substantive. The Exchange believes the amendments
would create a more user-friendly Fee Schedule.

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

    The Exchange does not believe that the proposed rule change will
impose any burden on competition not necessary or appropriate in
furtherance of the purposes of the Act.

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

    No written comments were either solicited or received.

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

    The foregoing rule change has become effective pursuant to Section
19(b)(3)(A)(ii) of the Act.\14\ At any time within 60 days of the
filing of the proposed rule change, the Commission summarily may
temporarily suspend such rule change if it appears to the Commission
that such action is necessary or appropriate in the public interest,
for the protection of investors, or otherwise in furtherance of the
purposes of the Act. If the Commission takes such action, the
Commission shall institute proceedings to determine whether the
proposed rule should be approved or disapproved.
---------------------------------------------------------------------------

    \14\ 15 U.S.C. 78s(b)(3)(A)(ii).
---------------------------------------------------------------------------

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 No. SR-Phlx-2012-06 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 No. SR-Phlx-2012-06. 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
a.m. and 3 p.m. Copies of such 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 No. SR-Phlx-2012-06 and should be
submitted on or before February 13, 2012.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
---------------------------------------------------------------------------

    \15\ 17 CFR 200.30-3(a)(12).
---------------------------------------------------------------------------

Kevin M. O'Neill,
Deputy Secretary.
[FR Doc. 2012-1583 Filed 1-25-12; 8:45 am]
BILLING CODE 8011-01-P


[Federal Register Volume 80, Number 33 (Thursday, February 19, 2015)]
[Notices]
[Pages 8884-8886]
[FR Doc No: 2015-03417]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-1524]

Repackaging of Certain Human Drug Products by Pharmacies and
Outsourcing Facilities; Draft Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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

SUMMARY: The Food and Drug Administration (FDA or the Agency) is
announcing the availability of a draft guidance for industry entitled
``Repackaging of Certain Human Drug Products by Pharmacies and
Outsourcing Facilities.'' This guidance describes the conditions under
which FDA does not intend to take action for violations of the Federal
Food, Drug, and Cosmetic Act (the FD&C Act), when a state-licensed
pharmacy, a Federal facility, or an outsourcing facility repackages
human drug products.
    When this guidance becomes final, the Agency may also consider
withdrawing or revising other guidance documents that address human
drug repackaging, including section 446.100 of the Compliance Program
Guidance (CPG) Manual, entitled ``Regulatory Action Regarding Approved
New Drugs and Antibiotic Drug Products Subjected to Additional
Processing or other Manipulations,'' which was issued in January 1991,
and section 460.100 of the CPG Manual, entitled ``Hospital Pharmacies--
Status as Drug Manufacturer,'' which was issued in October 1980.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by May 20, 2015.

ADDRESSES: Submit written requests for single copies of this guidance
to the Division of Drug Information, Center for Drug Evaluation and
Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg.
51, Rm. 2201, 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
guidance document.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Gail Bormel, Food and Drug
Administration, 10001 New Hampshire Ave., Silver Spring, MD 20903, 301-
796-3110.

SUPPLEMENTARY INFORMATION:

I. Announcement of Draft Guidance

    FDA is announcing the availability of a draft guidance for industry
entitled

``Repackaging of Certain Human Drug Products by Pharmacies and
Outsourcing Facilities.'' FDA regards repackaging as the act of taking
a finished drug product from the container in which it was distributed
by the original manufacturer and placing it into a different container
without further manipulation of the drug. If a drug is manipulated in
any other way, including if the drug is reconstituted, diluted, mixed,
or combined with another ingredient, that act is not considered
repackaging.
    Repackaged drugs are generally not exempt from any of the
provisions of the FD&C Act related to the production of drugs. For
example, repackaged drugs are generally subject to the premarket
approval, misbranding, and adulteration provisions of the FD&C Act,
including section 505 (concerning new drug applications), section
502(f)(1) (concerning labeling with adequate directions for use), and
section 501(a)(2)(B) (concerning current good manufacturing practice
(CGMP) (21 U.S.C. 355, 352(f)(1), and 351(a)(2)(B) of the FD&C Act).
    Further, drugs that are repackaged are not subject to sections 503A
and 503B of the FD&C Act (21 U.S.C. 353a and 353b). Therefore, drugs
repackaged by state-licensed pharmacies, Federal facilities, or
outsourcing facilities are not eligible for the exemptions provided
under those sections.
    This draft guidance describes the conditions under which FDA does
not intend to take action for violations of sections 505, 502(f)(1),
and, where specified in the guidance, section 501(a)(2)(B) of the FD&C
Act, when a state-licensed pharmacy, Federal facility, or registered
outsourcing facility repackages drug products. The guidance does not
address repackaging of nonprescription drugs; drugs that are intended
for use in animals; biological products subject to licensure under
section 351 of the Public Health Services Act (42 U.S.C. 262);
repackaging by entities that are not state-licensed pharmacies, Federal
facilities, or registered outsourcing facilities; removing a drug
product from the original container at the point of care for immediate
administration to a single patient after receipt of a patient-specific
prescription or order for that patient; or repackaging a solid oral
dosage form drug product by a state-licensed pharmacy for purposes of
dispensing the drug to a patient upon receipt of an individual patient-
specific prescription.
    Elsewhere in this issue of the Federal Register, the Agency is
making available for comment a draft guidance entitled ``Mixing,
Diluting, or Repackaging of Biological Products Outside the Scope of an
Approved Biologics License Application.'' When these two guidances
become final, they will address and clarify the Agency's policy
regarding hospital pharmacies repackaging and safely transferring
repackaged drugs to other hospitals within the same health system
during a drug shortage. Therefore, under section 506F(d) of the FD&C
Act, when FDA issues these as final guidances, section 506F will no
longer apply.
    This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). This guidance, when
finalized, will represent FDA's current thinking on repackaging human
drug products by pharmacies, Federal facilities, and outsourcing
facilities. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the requirements of the
applicable statutes and regulations.

II. Amendment or Withdrawal of Repackaging Guidance Documents

    When this guidance becomes final, the Agency may also consider
withdrawing or revising other guidance documents that address human
drug repackaging. These may include section 446.100 of the CPG Manual,
entitled ``Regulatory Action Regarding Approved New Drugs and
Antibiotic Drug Products Subjected to Additional Processing or other
Manipulations,'' which was issued in January 1991, and section 460.100
of the CPG Manual, entitled ``Hospital Pharmacies--Status as Drug
Manufacturer,'' which was issued in October 1980.

III. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

IV. Paperwork Reduction Act of 1995

    This draft guidance contains information collection provisions that
are subject to review by the Office of Management and Budget under the
Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description, and respondent description of the information collection
are given under this section with an estimate of the annual reporting
and recordkeeping burdens. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing the
collection of information.
    We invite comments on these topics: (1) Whether the proposed
collection of information is necessary for the proper performance of
FDA's functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
    Title: Repackaging of Certain Human Drug Products by Pharmacies and
Outsourcing Facilities; Guidance for Industry.
    Description: The draft guidance describes repackaging by state-
licensed pharmacies, Federal facilities, and outsourcing facilities
under section 503B of the FD&C Act, and it describes the conditions
under which FDA does not intend to take action for violations of
sections 505, 502(f)(1), and where specified, section 501(a)(2)(B) of
the FD&C Act, when a state-licensed pharmacy, or Federal facility, or
an outsourcing facility repackages drug products. The draft guidance
includes the following collection of information under the PRA:
    One condition in the draft guidance is that if a drug is repackaged
by an outsourcing facility, the label on the immediate container
(primary packaging, e.g., the syringe) of the repackaged product
includes the following information:
     The statement ``This drug product was repackaged by [name
of outsourcing facility].''
     The address and phone number of the outsourcing facility
that repackaged the drug product.
     The established name of the original, approved drug
product that was repackaged.
     The lot or batch number of the repackaged drug product.
     The dosage form and strength of the repackaged drug
product.

     A statement of either the quantity or volume of the
repackaged drug product, whichever is appropriate.
     The date the drug product was repackaged.
     The beyond-use-date of the repackaged drug product.
     Storage and handling instructions for the repackaged drug
product.
     The National Drug Code (NDC) number of the repackaged drug
product, if available.\1\
---------------------------------------------------------------------------

    \1\ The NDC number of the original approved drug product should
not be placed on the repackaged drug product.
---------------------------------------------------------------------------

     The statement ``Not for resale,'' and, if the drug is
distributed by an outsourcing facility other than pursuant to a
prescription for an individual identified patient, the statement
``Office Use Only.''
     If included on the label of the FDA-approved drug product
from which the drug product is being repackaged, a list of the active
and inactive ingredients, unless such information is included on the
label for the container from which the individual units are removed, as
described in this document.
    In addition, a condition in the draft guidance is that the label on
the container from which the individual units are removed for
administration (secondary packaging, e.g., the bag, box, or other
package in which the repackaged products are distributed) includes the
active and inactive ingredients, if the immediate product label is too
small to include this information, and directions for use, including,
as appropriate, dosage and administration, and the following
information to facilitate adverse event reporting: http://www.fda.gov/medwatch and 1-800-FDA-1088.
    Another condition in the draft guidance is that each repackaged
drug product is accompanied by a copy of the prescribing information
that accompanied the original drug product that was repackaged.
    We estimate that annually a total of approximately 10 outsourcing
facilities (``Number of Respondents'' in table 1, row 1) will each
design, test, and produce approximately 10 different labels
(``Frequency per Disclosure'' in table 1, row 1) for a total of 100
labels that include the information set forth in section III.A.11 of
the draft guidance (including directions for use) (``Total
Disclosures'' in table 1, row 1). We also estimate that designing,
testing, and producing each label will take approximately 0.5 hours for
each repackaged drug product (``Hours per Disclosure'' in table 1, row
1). The provision to add the statement http://www.fda.gov/medwatch and
1-800-FDA-1088 is not included in this burden estimate because it is
not considered a collection of information under the PRA because the
information is ``originally supplied by the Federal Government to the
recipient for the purpose of disclosure to the public'' (5 CFR
1320.3(c)(2)).
    We also estimate that annually a total of approximately 10
outsourcing facilities (``Number of Respondents'' in table 1, row 2)
will each produce a copy of prescribing information as set forth in
section III.A.11 of the draft guidance for approximately 10 repackaged
drug products (``Frequency per Disclosure'' in table 1, row 1) for a
total of 100 disclosures (``total disclosures'' in table 1, row 2). We
also estimate that providing prescribing information labeling will take
approximately 1 hour for each repackaged drug product (``Hours per
Disclosure'' in table 1, row 2). The provision to add http://www.fda.gov/medwatch and 1-800-FDA-1088 is not included in this burden
estimate because it is not considered a collection of information under
the PRA because the information is ``originally supplied by the Federal
Government to the recipient for the purpose of disclosure to the
public'' (5 CFR 1320.3(c)(2)).
    The total estimated third-party disclosure burden resulting from
the draft guidance is as follows:

                             Table 1--Estimated Annual Third-Party Disclosure Burden
----------------------------------------------------------------------------------------------------------------
   Repackaging by outsourcing        Number of     Frequency per       Total         Hours per
           facilities               respondents     disclosure      disclosures     disclosure      Total hours
----------------------------------------------------------------------------------------------------------------
Designing, testing, and                       10              10             100              .5              50
 producing each label on
 immediate containers, packages
 and/or outer containers........
Prescribing information labeling              10              10             100               1             100
 produced for each repackaged
 drug product...................
                                 -------------------------------------------------------------------------------
    Total.......................  ..............  ..............  ..............  ..............             150
----------------------------------------------------------------------------------------------------------------
There are no capital costs or operating and maintenance costs associated with this collection of information.
*(30 minutes)

    The draft guidance also references registration, product reporting,
and CGMP requirements for outsourcing facilities. In the Federal
Register of December 4, 2013 (78 FR 72899), FDA estimated the burden
resulting from outsourcing facility registration. In the Federal
Register of December 4, 2013 (78 FR 72897), FDA estimated the burden
resulting from outsourcing facility interim product reporting. In the
Federal Register of July 2, 2014 (79 FR 37743), FDA estimated the
burden resulting from outsourcing facility compliance with CGMP
requirements.

V. Electronic Access

    Persons with access to the Internet can obtain the document at
either http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/default.htm or http://www.regulations.gov.

    Dated: February 11, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-03417 Filed 2-18-15; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: October 19, 2006 (Volume 71, Number 202)]
[Notices]
[Page 61738-61739]
[DOCID:fr19oc06-42]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Docket No. ER06-1397-000]

Allegheny Ridge Wind Farm, LLC; Notice of Issuance of Order

October 13, 2006.
    Allegheny Ridge Wind Farm, LLC (Allegheny Wind) filed an
application for market-based rate authority, with an accompanying rate
tariff. The proposed market-based rate tariff provides for the sale of
energy, capacity and ancillary services at market-based rates.
Allegheny Wind also requested waivers of various Commission
regulations. In particular, Allegheny Wind requested that the
Commission grant blanket approval under 18 CFR Part 34 of all future
issuances of securities and assumptions of liability by Allegheny Wind.
    On September 21, 2006, pursuant to delegated authority, the
Director, Division of Tariffs and Market Development--West, granted the
requests for blanket approval under Part 34. The Director's order also
stated that the Commission would publish a separate notice in the
Federal Register establishing a period of time for the filing of
protests. Accordingly, any person desiring to be heard or to protest
the blanket approvals of issuances of securities or assumptions of
liability by Allegheny Wind should file a motion to intervene or
protest with the Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214
of the Commission's Rules of Practice and Procedure. 18 CFR 385.211,
385.214 (2004).
    Notice is hereby given that the deadline for filing motions to
intervene or protest is November 13, 2006.
    Absent a request to be heard in opposition by the deadline above,
Allegheny Wind is authorized to issue securities and assume obligations
or liabilities as a guarantor, indorser, surety, or otherwise in
respect of any security of another person; provided that such issuance
or assumption is for some lawful object within the corporate purposes
of Allegheny Wind, compatible with the public interest, and

is reasonably necessary or appropriate for such purposes.
    The Commission reserves the right to require a further showing that
neither public nor private interests will be adversely affected by
continued approvals of Allegheny Wind's issuance of securities or
assumptions of liability.
    Copies of the full text of the Director's Order are available from
the Commission's Public Reference Room, 888 First Street, NE.,
Washington, DC 20426. The Order may also be viewed on the Commission's
Web site at http://www.ferc.gov, using the eLibrary link. Enter the

docket number excluding the last three digits in the docket number
filed to access the document. Comments, protests, and interventions may
be filed electronically via the Internet in lieu of paper. See 18 CFR
385.2001(a)(1)(iii) and the instructions on the Commission's Web site
under the ``e-Filing'' link. The Commission strongly encourages
electronic filings.

Magalie R. Salas,
Secretary.
 [FR Doc. E6-17496 Filed 10-18-06; 8:45 am]

BILLING CODE 6717-01-P