[Federal Register Volume 78, Number 49 (Wednesday, March 13, 2013)]
[Notices]
[Pages 15956-15957]
[FR Doc No: 2013-05725]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2011-D-0595]

Guidance for Industry on Tablet Scoring: Nomenclature, Labeling,
and Data for Evaluation; 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 guidance for industry entitled ``Tablet Scoring:
Nomenclature, Labeling, and Data for Evaluation.'' This guidance
provides recommendations to sponsors of new drug applications (NDAs)
and abbreviated new drug applications (ANDAs) regarding what criteria
should be met when evaluating and labeling tablets that have been
scored. (A scoring feature facilitates tablet splitting, which is the
practice of breaking or cutting a higher-strength tablet into smaller
portions.) Specifically, this guidance recommends guidelines to follow,
data to provide, and criteria to meet and detail in an application to
support approval of a scored tablet; and nomenclature and labeling for
approved scored tablets.
    This guidance does not address specific finished-product release
testing, where additional requirements may apply to scored tablets.
This guidance does not describe the medical practice conditions under
which tablet splitting is considered or recommended.

DATES: Submit either electronic or written comments on Agency guidances
at any time.

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: Russell Wesdyk, Center for Drug
Evaluation and Research (HFD-003), Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 51, Rm. 4182, Silver Spring, MD 20993-0002,
301-796-2400.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is announcing the availability of a guidance for industry
entitled ``Tablet Scoring: Nomenclature, Labeling, and Data for
Evaluation.'' This guidance provides recommendations to sponsors of
NDAs and ANDAs regarding what criteria should be met when evaluating
and labeling tablets that have been scored. (A scoring feature
facilitates tablet splitting, which is the practice of breaking or
cutting a higher-strength tablet into smaller portions.) Specifically,
this guidance recommends:
     Guidelines to follow, data to provide, and criteria to
meet and detail in an application to support approval of a scored
tablet; and
     Nomenclature and labeling for approved scored tablets.
    On August 30, 2011 (76 FR 53909), FDA announced the availability of
the draft version of this guidance. The public comment period closed on
November 28, 2011. A number of comments were received from the public,
all of which the Agency considered carefully as it finalized the
guidance and made appropriate changes. The Agency also held an Advisory
Committee for Pharmaceutical Science and Clinical Pharmacology meeting
on August 9, 2012, to discuss the draft guidance. Any changes to the
guidance were minor and made to clarify statements in the draft
guidance.
    The Agency has previously considered tablet scoring as an issue
when determining whether a generic drug product is the same as the
reference listed drug (RLD). One characteristic of a tablet dosage form
is that it may be manufactured with a score or scores. This
characteristic is useful because the score can be used to facilitate
the splitting of the tablet into fractions when less than a full tablet
is desired for a dose. Although there are

no standards or regulatory requirements that specifically address
scoring of tablets, the Agency recognizes the need for consistent
scoring between a generic product and its RLD.
    Consistent scoring ensures that the patient is able to adjust the
dose, by splitting the tablet, in the same manner as the RLD. This
enables the patient to switch between products made by different
manufacturers without encountering problems related to the dose. In
addition, consistent scoring ensures that neither the generic product
nor the RLD has an advantage in the marketplace because one is scored
and one is not.
    The Center for Drug Evaluation and Research's Drug Safety Oversight
Board considered the practice of tablet splitting at its October 2009
and November 2010 meetings. During those meetings, they discussed how
insurance companies and doctors are increasingly recommending that
patients split tablets, either to adjust the patients' dose or as a
cost-saving measure. Because of this, the Agency conducted internal
research on tablet splitting and concluded that in some cases, there
are possible safety issues, especially when tablets are not scored or
evaluated for splitting. The Agency's concerns with splitting a tablet
included variations in the tablet content, weight, disintegration, or
dissolution, which can affect how much drug is present in a split
tablet and available for absorption. In addition, there may be
stability issues with splitting tablets.
    Tablet splitting also is addressed in pharmacopeial standards. The
European Pharmacopeia currently applies accuracy of subdivision
standards for scored tablets--and has at various times also included
standards for content uniformity, weight variation, and loss of mass--
while the United States Pharmacopeia published a Stimuli article in
2009 proposing criteria for loss of mass and accuracy of subdivision
for split tablets.
    As an outgrowth of these discussions, FDA is providing
recommendations for application content regarding the scientific basis
for functional scoring on solid oral dosage form products to ensure the
quality of both NDA and ANDA scored tablet products. To accomplish
this, the Agency has developed consistent and meaningful criteria by
which scored tablets can be evaluated and labeled by: (1) Providing a
harmonized approach to chemistry, manufacturing, and controls reviews
of scored tablets; (2) ensuring consistency in nomenclature (e.g.,
score versus bisect) and labeling; and (3) providing information
through product labeling or other means to health care providers.
    This guidance is being issued consistent with FDA's good guidance
practices regulation (21 CFR 10.115). The guidance represents the
Agency's current thinking on tablet scoring: Nomenclature, labeling,
and data for evaluation. 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

    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.

III. The Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in Sec.  201.57 (21 CFR 201.57) and 21 CFR
314.50 and 314.70 have been approved under OMB control numbers 0910-
0572 (for Sec.  201.57) and 0910-0001 (for 21 CFR part 314).

IV. Electronic Access

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

    Dated: March 7, 2013.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2013-05725 Filed 3-12-13; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register: May 25, 2010 (Volume 75, Number 100)]
[Notices]
[Page 29334-29335]
[DOCID:fr25my10-50]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 2114-209]

Public Utility District No. 2 of Grant County, WA; Notice of
Application for Amendment of License and Soliciting Comments, Motions
To Intervene, and Protests

May 18, 2010.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection:
    a. Application Type: Amendment of License.
    b. Project No: 2114-209.
    c. Date Filed: February 26, 2010.
    d. Applicant: Public Utility District No. 2 of Grant County,
Washington.
    e. Name of Project: Priest Rapids Hydroelectric Project.
    f. Location: Columbia River, in Grant, Yakima, Kittitas, Douglas,
Benton, and Chelan Counties, Washington. The project occupies Federal
lands managed by the U.S. Bureau of Land Management, U.S. Bureau of
Reclamation, U.S. Department of Energy, U.S. Department of Army, and
U.S. Fish and Wildlife Service.
    g. Filed Pursuant to: Federal Power Act, 16 U.S.C. 791a-825r.
    h. Applicant Contact: Kelly Larimer, Lands and Recreation Resources
Manager, Public Utility District No. 2 of Grant County, Washington,
P.O. Box 878, Ephrata, WA 98823;<PHONE_NUMBER>.
    i. FERC Contact: For questions on this notice, please contact--
Jaime Blakesley, Telephone<PHONE_NUMBER>, and e-mail:
<EMAIL_ADDRESS>    j. Deadline for filing comments, motions to intervene, and protest:
June 18, 2010.
    All documents (original and eight copies) should be filed with:
Secretary, Federal Energy Regulatory Commission, 888 First Street, NE.,
Washington, DC 20426.
    The Commission's Rules of Practice and Procedure require all
interveners filing documents with the Commission to serve a copy of
that document on each person whose name appears on the official service
list for the project. Further, if an intervener files comments or
documents with the Commission relating to the merits of an issue that
may affect the responsibilities of a particular resource agency, they
must also serve a copy of the document on that resource agency. A copy
of any motion to intervene must also be served upon each representative
of the

Applicant specified in the particular application.
    k. Description of Request: The licensee proposes to amend the
recreation resource management plan and implementation schedules under
article 418 of its license. The proposed amendment includes
modifications and information pertaining to Crab Creek Corridor
(Burkett Lake Recreation Area), Priest Rapids Park (Desert Aire),
Priest Rapids Dam Picnic Area, Crescent Bar Recreation Provisions, as
well as a revised implementation schedule for the recreation
requirements outlined in Article 418.
    l. Locations of the Application: A copy of the application is
available for inspection and reproduction at the Commission's Public
Reference Room, located at 888 First Street, NE., Room 2A, Washington,
DC 20426, or by calling<PHONE_NUMBER>. This filing may also be viewed
on the Commission's Web site at http://www.ferc.gov using the
``eLibrary'' link. Enter the docket number (P-2114) excluding the last
three digits in the docket number field to access the document. You may
also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
call 1-866-208-3676 or e-mail<EMAIL_ADDRESS>for TTY, call
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item (h) above.
    m. Individuals desiring to be included on the Commission's mailing
list should so indicate by writing to the Secretary of the Commission.
    n. Comments, Protests, or Motions to Intervene: Anyone may submit
comments, a protest, or a motion to intervene in accordance with the
requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211,
.214. In determining the appropriate action to take, the Commission
will consider all protests or other comments filed, but only those who
file a motion to intervene in accordance with the Commission's Rules
may become a party to the proceeding. Any comments, protests, or
motions to intervene must be received on or before the specified
comment date for the particular application.
    o. Any filings must bear in all capital letters the title
``COMMENTS'', ``PROTEST'', or ``MOTION TO INTERVENE'', as applicable,
and the Project Number of the particular application to which the
filing refers.
    p. Agency Comments: Federal, State, and local agencies are invited
to file comments on the described application. A copy of the
application may be obtained by agencies directly from the Applicant. If
an agency does not file comments within the time specified for filing
comments, it will be presumed to have no comments. One copy of an
agency's comments must also be sent to the Applicant's representatives.
    q. 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 at http://www.ferc.gov
under the ``e-Filing'' link.

Kimberly D. Bose,
Secretary.
[FR Doc. 2010-12502 Filed 5-24-10; 8:45 am]
BILLING CODE 6717-01-P


2,4-DB (030801)

Screening Level Usage Analysis (SLUA)

Date: August 3rd, 2012

What is a Screening Level Usage Analysis (SLUA)?

Available estimates of pesticide usage data for a particular active
ingredient that is used on agricultural crops in the United States.

Pesticide usage data obtained from various sources.  The data are then
merged, averaged, and rounded so that the presented information is not
proprietary, business confidential, or trade secret.

What does it contain?

Pesticide usage data for a single active ingredient only.

Agricultural use sites (crops) that the pesticide is reported to be used
on.

Available pesticide usage information from U.S. states that produce 80%
or more of a crop, in most cases, or less than 80%, in rare cases,
depending on the scope of the survey and available resources.

Annual percent of crop treated (average & maximum) for each agricultural
crop.

Average annual pounds of the pesticide applied for each agricultural
crop (i.e., for the states surveyed, not for the entire United States).

What assumptions can I make about the reported data?

Average pounds of active ingredient applied - Values are calculated by
merging pesticide usage data sources together; averaging across all
observations, then rounding.  Note:  If the estimated value is less than
500, then that value is labeled <500.  Estimated values between 500 &
<1,000,000 are rounded to 1 significant digit.  Estimated values of
1,000,000 or greater are rounded to 2 significant digits.)

Average percent of crop treated - Values are calculated by merging data
sources together; averaging by year, averaging across all years, &
rounding to the nearest multiple of 5.  Note:  If the estimated value is
less than 2.5, then the value is labeled <2.5.  If the estimated value
is less than 1, then the value is labeled <1.

Maximum percent of crop treated - Value is the single maximum value
reported across all data sources, across all years, & rounded up to the
nearest multiple of 5.  Note:  If the estimated value is less than 2.5,
then the value is labeled <2.5.

What are the data sources used?

USDA-NASS (United States Department of Agriculture’s National
Agricultural Statistics Service) – pesticide usage data from 2003 to
2010.

Private pesticide market research – pesticide usage data from 2003 to
2010.

California Department of Pesticide Regulation (DPR) Pesticide Use
Reporting (PUR) data for 2003 to 2010.

What are the limitations to the data?

Additional registered uses may exist but are not included because the
available surveys do not report usage (e.g., small acreage crops).

Lack of reported usage data for the pesticide on a crop does not imply
zero usage.

Usage data on a particular site may be noted in data sources, but not
quantified.  In these instances, the site would not be reported in the
SLUA.

Non-agricultural use sites (e.g., turf, post-harvest, mosquito control,
etc.) are not reported in the SLUA.  A separate request must be made to
receive these estimates.

Some sites show some use, even though they are not on the label.  This
usage could be due to various factors, including, but not limited to
Section 18 requests, existing stocks of the chemical, data collection
errors, and experimental use permits (EUPs).

August 3rd, 2012

Screening Level Estimates of Agricultural Uses of 2,4-DB (030801)

Sorted Alphabetically

(Reporting Timeframe: 2003-2010)

Percent Crop Treated

Crop	Lbs. A.I.	Average	Maximum

1	Alfalfa	60,000	<1	<2.5

2	Pasture +	40,000	<1	<2.5

3	Peanuts	200,000	40	60

4	Soybeans 	20,000	<1	<2.5

5	Wheat +	20,000	<1	<2.5

All numbers rounded.

	<2.5	Less than 2.5 percent of crop treated

<1	Less than 1 percent of crop treated

+	Crops not known to be listed on active end use product registrations
or as Section 18 emergency

exemptions when this report was run

SLUA data sources include:

USDA-NASS (United States Department of Agriculture's National
Agricultural Statistics Service)

Private Pesticide Market Research

California DPR (Department of Pesticide Regulation)

These results reflect amalgamated data developed by the Agency and are
releasable to the public.


EPA's policy is that public comments, whether submitted electronically or in paper, will be made available for public viewing in EDOCKET as EPA receives them and without change, unless the comment contains copyrighted material, Confidential Business Information ( CBI), or other information whose public disclosure is restricted by statute. When EPA identifies a comment containing copyrighted material, EPA will provide a reference to that material in the version of the comment that is placed in EDOCKET. The entire printed comment, including the copyrighted material, will be available in the public docket. Although identified as an item in the official docket, information claimed as CBI, or whose disclosure is otherwise restricted by statute, is not included in the official public docket, and will not be available for public viewing in EDOCKET. For further information about the electronic docket, see EPA's Federal Register notice describing the electronic docket at 67 FR 38102 ( May 31, 2002), or go to www. epa. gov/ edocket.

Title: Population based pilot study of children's environmental health in support of the National Children's Study.

Abstract: An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in 40 CFR are listed in 40 CFR part 9. The proposed study will be conducted by the Epidemiology and Biomarkers Branch, Human Studies Division, National Health and Environmental Effects Research Laboratory, Office of Research and Development, US EPA. The US EPA will conduct this research in partnership with the National Children's Study ( NCS) Program Office at the National Institute of Child Health and Human Development ( NICHD) as well as the other lead agencies of the NCS: the Centers for Disease Control and Prevention ( CDC) and the National Institute of Environmental Health Sciences ( NIEHS).

This proposed data collection will pilot test logistics, protocols and procedures for the NCS, a long term study of the influence of environmental factors on child health and development. The goal is to improve the efficiency of the implementation of NCS by testing procedures for population based sampling and subject recruitment, proposed study logistics and estimates of 80 subject burden, and evaluating data collection strategies including interviews and acquisition of biologic and environmental samples. Further details on the NCS, including the Study Plan, can be found at www. nationalchildrensstudy. gov.

Approximately 10,000 households will be screened and 2,740 women will be enrolled who meet eligibility criteria, primarily defined by age and likelihood of pregnancy. The schedule of visits follows the proposed NCS Study Plan. Briefly, women who are planning pregnancy will be visited bimonthly, women with lower likelihood of pregnancy will be visited once; pregnant women will have a home visit in the first trimester and a clinic visit in the second and third trimester. A hospital visit at birth is planned as well as home visits to follow up with the mother and infant at 1, 6, 12, and 18 months of age. Data from interviews as well as biologic and environmental samples will address the relationship between common environmental factors and the physical and developmental growth of children. Qualitative assessments of the participants'

perceptions about the study will be gathered at each visit to enhance the lessons that can be learned to aid the successful implementation of the NCS.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information varies depending on the eligibility and pregnancy status of women at the time of enrollment. Detailed estimates regarding the number of potential respondents and burden associated with each visit are provided in the EDOCKET. Table 1 provides the annual burden hours and cost by respondent type.

Approximately 10 minutes per household is required to determine potentially eligible occupants.

Potentially eligible women are asked to complete a 10 minute screening interview. The estimated total burden for a fully participating woman ranges from 8 hours ( for a woman enrolled at delivery) to 21 hours ( for a " high likelihood" woman who receives all contacts in the preconception period) over a three year period. The burden for husbands/ partners is somewhat more consistent because they only receive one visit in each of the preconception, pregnancy, and childhood visit periods; each visit is approximately 1 hour. The burden for children ranges from 10 minutes at the birth visit to approximately 2 hours for full participation up to 18 months of age.

Burden means the total time, effort, or financial resources expended by persons to generate,

maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with 81 any previously applicable instructions and requirements; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

Respondents/ Affected Entities: Entities potentially affected by this action are women aged 18

40 years, pregnant women, their husbands or partners, and their children who live in selected areas of North Carolina.

Estimated Number of Respondents: 10,000 Frequency of Response: On occasion Estimated Total Annual Hour Burden: 4,585 Estimated Total Annual Cost to Respondents: $ 82,728. There are no annualized capital costs or O& M costs.

Changes in the Estimates: Not applicable; this is a new information collection.

Dated: ________________

______________________

Rebecca L. Calderon, Director, Human Studies Division 82 Table 1. Annual Burden and Cost by Respondent Types Type of Respondent Estimated Number of Respondents Annual Burden ( Hours) Annual Burden ( Cost) 2 Household Unit 10,000 278 $ 4,540 Women Screened, Not Enrolled 1,750 194 $ 3,168 Women Screened and Enrolled High likelihood of pregnancy 167 660 $ 10,778 Moderate likelihood of pregnancy 572 962 $ 15,710 Low likelihood of pregnancy 1,797 895 $ 14,615 Pregnant at enrollment 1 169 642 $ 10,484 Enrolled at delivery 35 78 $ 1,274 Partners 728 375 $ 6,124 Children 406 201 $ 1,035 Medical Staff 53 300 $ 15,000 Total 15,677 4,585 $ 82,728 1 Includes 48 volunteers assumed to be pregnant at enrollment 2 Burden hours are multiplied by the following rates: $ 16.33 for women and their partners, $ 5.15 for children, and $ 50.00 for medical staff. Source: Greensboro Winston Salem High Point May 2004 Metropolitan Area Occupational Employment and Wage Estimates from the Bureau of Labor Statistics ( http:// www. bls. gov/ oes/ current/ oes_ 3120. htm# b00 0000). 83 References Final Report for Task 2, Develop a Preliminary Study Plan for Recruitment and Retention with Options for Specific Measures. Prepared by RTI for EPA Work Assignment 03 04, Pilot Cohort Planning and Support.

Pivetz, T., Iroz Elardo, N., Strauss, W., Rust, S., Menkedick, J. Brief on Estimated Sample Size of Women Needed to Result in 100,000 Live Births ( Revised June 15, 2004). Available at http:// www. nationalchildrensstudy. gov/ research/ analytic_ reports/

Groves, R. M., and Couper, M. P. ( 1998). Nonresponse in Household Interview Surveys. New York: John Wiley & Sons, Inc. 84 Appendix B: Final Visit Schedule and Burden Estimates Contract No. 68 D 02 069 August 9, 2005 Final Visit Schedule and Burden Estimates Population based pilot study of children's environmental health in support of the National Children's Study: Pilot Cohort Planning and Support Work Assignment Number: 03 04 RTI Project No. 08601.002.004 Prepared for: EPA Work Assignment Manager: Pauline Mendola, Ph. D.

Attn: Ms. Frances Legg U. S. Environmental Protection Agency RTP Procurement Operations Division ( D143 01) 4930 Old Page Road Durham, NC 27709 Prepared by: RTI Work Assignment Leader: Sharon Myers, M. P. H. RTI Principal Investigator: Richard Kwok, Ph. D. RTI International 3040 Cornwallis Road Research Triangle Park, NC 27709 Telephone: ( 919) 541 7316 Fax: ( 919) 541 7250 E mail: sharonm@ rti. org RTI Contracting Officer: Kelly Koeller Anna Office of Research Contracts RTI International P. O. Box 12194 Research Triangle Park, NC 27709 2194 Telephone: ( 919) 316 3746 Fax: ( 919) 541 6624 E mail: kellyk@ rti. org 85 This report provides final estimates for respondent burden levels for each study visit/ contact with women enrolled in the NCS Pilot Cohort, their male partners, and the children born to them. The schedule for pre conception visits will depend on the woman's likelihood of pregnancy, classified by the NCS Study Plan as high, moderate, and low " risk." Women with a high or moderate likelihood of pregnancy will be visited in their homes within 2 weeks of their enrollment to collect interview data, biologic and environmental samples, and anthropometric measurements. After this initial home visit, the schedule for high and moderate likelihood groups will vary, with a combination of home visits and telephone calls at varying intervals. It is estimated that 70 to 90 percent of the women in the high likelihood group will get pregnant within 6 months of enrollment; therefore, follow up for this group is most intense. The low likelihood group will not receive home visits, rather, women in this group will be asked to contact RTI in the event that their pregnancy plans change. The only follow up with this group will be by telephone at 12 months after enrollment.

Once enrolled women become pregnant, the visit schedule will follow that defined in the NCS Study Plan. For the NCS Pilot Cohort, however, we also plan to enroll women after their first trimester and at delivery. These women will be folded into the NCS Visit Schedule at the appropriate time point.

Preliminary sampling estimates from the Final Task 2 Report, Develop a Preliminary Study Plan for Recruitment and Retention with Options for Specific Measures, are that approximately 10,000 occupied households will be visited and that approximately 85%

( n= 8,770) will be rostered to identify age eligible women. As a result, we assume that approximately 4,426 women will be screened and of those, 2,657 will be enrolled in the study.

We also assume that 35 women will be enrolled at delivery and another 48 women who express interest in the study ( i. e., volunteers) will be screened and enrolled, for a total of 2,740 women.

These 2,740 enrolled women are estimated to yield 406 births over the study enrollment period,

as shown in Table 1 below. Estimates of enrollment rates and birth rates were adapted from the Battelle document, Brief on Estimated Sample Size of Women Needed to Result in 100,000 Live Births ( Pivetz, Iroz Elardo, Strauss, Rust, and Menkedick, 2004). 86 Table 1 Number of eligible women screened and enrolled, and number of births expected by group Enrolled Births Group Number Screened N % N %

Pregnant at enrollment 186 121 65 108 89 High likelihood of pregnancy 256 167 65 57 34 Moderate likelihood of pregnancy 962 572 59 50 9 Low likelihood of pregnancy 3,022 1,797 59 115 6 Subtotal of women from household recruiting 4,426 2,657 60 330 12 Women at delivery N/ A 35  35 100 Volunteers 64 48 75 41 85 Total 4,490 2,740  406 15 The burden for household rostering is expected to take up to 5 minutes per household, and any adult household member can provide the necessary information. Although we do not expect 100%

response, the maximum burden to roster 10,000 households is 833 hours. Realistically, closer to 85% of these households will agree to the rostering, for a total of 731 burden hours.

For purposes of calculating the respondent burden levels, Table 2 provides estimates of the burden per respondent by visit/ contact, the estimated number of respondents for each visit, and the total burden for all respondents at each visit. A number of assumptions have been made in estimating the number of respondents for each visit:

The total number pregnant in each likelihood group is estimated as described above.

The distribution of time to pregnancy for the high likelihood group has been adapted from information received from NICHD as a result of a literature review performed for a study of women seeking to become pregnant.

The distribution of time to pregnancy for the moderate likelihood group uses somewhat similar rates as the high likelihood group, but delayed by 1 month. For the low likelihood group, the number of total pregnancies was almost equally divided by time. These are general assumptions made due to lack of better information to estimate these rates.

Women will move between likelihood groups throughout the enrollment period, but we have not made any estimates of these rates or the direction of movement.

The Battelle report previously referenced assumed a 0.003% attrition rate per month; we have used a more conservative estimate of 1% per month for the pre conception visits.

The number of partner respondents at each applicable visits has been estimated at 70% of the number of women.

The burden estimates for post conception visits, from the first trimester to 18 months of age, are detailed in Table 3. The pregnancies resulting from the prepregnancy group will all begin with the first trimester visit. For this group, we have assumed that there will be a 5% attrition rate between each visit.

For the 121 women pregnant at enrollment and the 48 volunteers, we are assuming that 1/ 3 of the women 87 will enter at each of the three trimester visits. After the birth visit, we estimate a 5% attrition rate per visit.

Finally, the women who are enrolled at delivery will begin with the birth visit, and it is estimated that there will be a 5% attrition rate for each subsequent visit.

Table 3 also includes burden estimates for medical facility staff who will be asked to assist in biologic sample collection and clinical measurements at each of the clinic visits ( OGTT, 2nd trimester,

3rd trimester, and delivery). For purposes of estimating burden, we have assumed that half of the biologic samples in the OGTT and second and third trimester visits will be collected by clinic staff. For the biologic samples collected at birth, we are assuming that 85% of the samples will by collected by hospital staff. Samples will be collected by contractor staff in those instances that hospitals or clinics choose not to participate in the study. Furthermore, the burden on the medical staff for the clinic visits has been calculated using the burden for the visit multiplied by the number of women at each clinic visit, rather than by the number of medical staff. The overall burden on medical staff for collection of samples will be shared across a team of staff members, and the overall size of that team is reflected in the " Number of respondents per visit" column. For example, a team of several physician's office staff would be responsible for collecting the biologic samples for the women who receive care at a specific practice.

The figures in these tables illustrate the wide range of burden level and frequency of responses depending on the pregnancy plans or stage of pregnancy of enrolled women. Women in the " high likelihood of pregnancy" group who do not become pregnant until the end of the pre conception visit schedule will have the highest burden, since they will receive all pre conception visits as well as the pregnancy and childhood visits. Women who remain in the " low likelihood of pregnancy" group throughout the pre conception period and who do not become pregnant have the lowest burden, as they will receive only three 10 minute telephone contacts. Tables 4 through 6 below provide the minimum and maximum for the range in response frequency and burden hours, by respondent type. Table 4 provides statistics on the Pre conception contacts, i. e. contacts from household screening to conception. Table 5 gives similar statistics for Pregnancy visits, and Table 6, for all visits from delivery to 18 months. 88 Table 2 Burden estimates for pre conception visits Screening ( H) 1 Initial ( H) # 1 ( T) # 2 ( H) # 2 ( T) # 3 ( H) # 3 ( H) # 4 ( H) # 4 ( T) # 5 ( T) # 6 ( T) Pregnancy tests Event Form Moving Quest.

Burden ( minutes) per respondent Women High likelihood of pregnancy 20 150 10 90 10 45 10 45 10 10 10 5 5 5 Moderate likelihood of pregnancy 20 150 10  10  10  10 10  5 5 5 Low likelihood of pregnancy 20  10          5

Pregnant at enrollment 20

Partners  75

Children

Number of respondents per visit Women High likelihood of pregnancy 167 167 167 151 132 126 120 117 110 101 95 1,453 2 953 554 Moderate likelihood of pregnancy 572 572 547 0 508 0 489 0 469 450 0 572 2 4503 1894 Low likelihood of pregnancy 1,797 0 1,491 0 0 0 0 0 0 0 0 0 12503 0 Pregnant, 1st trimester 56 0 0 0 0 0 0 0 0 0 0 0 0 0 Pregnant, 2nd trimester 56 0 0 0 0 0 0 0 0 0 0 0 0 0 Pregnant, 3rd trimester 57 0 0 0 0 0 0 0 0 0 0 0 0 0 Enrolled at delivery 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Partners 0 517 0 0 0 0 0 0 0 0 0 0 0 0 Children 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Total burden ( hours)

Women High likelihood of pregnancy 56 418 28 227 22 95 20 88 18 17 16 121 8 5 Moderate likelihood of pregnancy 191 1430 91 0 85 0 82 0 78 75 0 48 38 16 Low likelihood of pregnancy 599 0 249 0 0 0 0 0 0 0 0 0 104 0 Pregnant, 1st trimester 19 0 0 0 0 0 0 0 0 0 0 0 0 0 Pregnant, 2nd trimester 19 0 0 0 0 0 0 0 0 0 0 0 0 0 Pregnant, 3rd trimester 19 0 0 0 0 0 0 0 0 0 0 0 0 0 Enrolled at delivery 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Partners 0 646 0 0 0 0 0 0 0 0 0 0 0 0 Children 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 H= home visit; T= telephone 2 Assume one test per month for high likelihood group, one test at first home visit for moderate likelihood group.

3 Assume one event per year 4 Assume one third of women move 89 Table 3 Burden estimates for pregnancy and birth/ childhood visits Pregnancy Visits Birth/ Childhood Visits Any first visit: basic ( H) 1 # 1 ( H) OGTT ( C) 2 # 2 ( C) # 3 ( C) Birth ( C) 1 month ( H) 6 months ( H) 12 months ( H) 18 months ( H) Event Form4 Moving Questions6 Burden ( minutes) per respondent Women High likelihood of pregnancy  90 150 180 180 10 60 120 90 120 5 5 Moderate likelihood of pregnancy  90 150 180 180 10 60 120 90 120 5 5 Low likelihood of pregnancy 155 90 150 180 180 10 60 120 90 120 5 5 Pregnant at enrollment 155 90 150 180 180 10 60 120 90 120 5 5 Enrolled at delivery 155     20 60 120 90 120 5 5 Partners 75 30      40

Children      10 20 20 30 20

Medical staff 3   30 60 60 90

Number of respondents per visit Women High likelihood of pregnancy 0 66 7 63 60 57 54 51 48 46 256 40 Moderate likelihood of pregnancy 0 59 6 56 53 50 48 46 44 42 230 35 Low likelihood of pregnancy 133 133 13 127 121 115 109 104 99 94 521 80 Pregnant, 1st trimester 56 56 6 53 50 48 45 43 41 40 217 33 Pregnant, 2nd trimester 56 0 0 56 53 50 48 45 43 40 226 16 Pregnant, 3rd trimester 57 0 0 0 53 51 49 47 44 41 232 16 Enrolled at delivery 33 0 0 0 0 35 33 31 29 28 156 11 Partners 211 88 0 0 0 0 0 257 0 0 0 0 Children 0 0 0 0 0 406 386 367 348 331 0 0 Medical staff 3 0 0 16 178 195 345 0 0 0 0 0 0 90 Table 3 Burden estimates for pregnancy and birth/ childhood visits ( cont.)

Pregnancy Visits Birth/ Childhood Visits Any first visit: basic ( H) 1 # 1 ( H) OGTT ( C) 2 # 2 ( C) # 3 ( C) Birth ( C) 1 month ( H) 6 months ( H) 12 months ( H) 18 months ( H) Event Form Moving Questions Total burden ( hours)

Women High likelihood of pregnancy 0 99 18 189 180 10 54 102 72 92 21 3 Moderate likelihood of pregnancy 0 89 15 168 159 8 48 92 66 84 19 3 Low likelihood of pregnancy 33 200 33 381 363 19 109 208 149 188 43 7 Pregnant, 1st trimester 14 84 15 159 150 8 45 86 62 80 18 3 Pregnant, 2nd trimester 14 0 0 168 159 8 48 90 65 80 19 1 Pregnant, 3rd trimester 14 0 0 0 159 9 49 94 66 82 19 1 Enrolled at delivery 14 0 0 0 0 12 33 62 44 56 13 1 Partners 264 44 0 0 0 0 0 171 0 0 0 0 Children 0 0 0 0 0 68 129 122 174 110 0 0 Medical staff 3 0 0 8 178 195 518 0 0 0 0 0 0 1 H= home visit; C= Clinic/ Hospital 2 Oral glucose tolerance test; assume 10% of women in pre pregnancy and first trimester groups will participate.

3 The burden on the medical staff for the clinic visits has been calculated using the burden per woman multiplied by the number of women at each clinic visit, rather than by the number of medical staff. The overall burden on medical staff for collection of samples will be shared across a team of staff members, and the overall size of that team is reflected in the " Number of respondents per visit" column.

4 Assumes 4 events per year per child and 1 event per year for the woman.

5 The burden for any first basic visit is in addition to the burden associated with the visit in which the woman first enrolls. For example, the 1 month visit for woman enrolled at delivery is 75 minutes: 60 minutes for the 1 month protocol plus 15 min for additional questions.

6 Assume one third of women move during pregnancy visit and one third move during childhood visits. 91 Table 4 Estimated burden for screening and pre conception contacts Type of Respondent Estimated Number of Respondents Minimum Number of Responses Maximum Number of Responses Minimum Burden Hours per Response Maximum Burden Hours per Response Estimated Total Burden Hours Household Unit 10,000 1 1 0.08 0.08 833 Women Screened, Not Enrolled 1,750 1 1 0.33 0.33 578 Women Screened and Enrolled High likelihood of pregnancy 167 2 10 0.17 2.50 1,124 Moderate likelihood of pregnancy 572 2 7 0.17 2.50 2,079 Low likelihood of pregnancy 1,797 1 2 0.17 0.33 848 Pregnant at enrollment 1,2 169 1 1 0.33 0.33 56 Enrolled at delivery 0 0 0 0.00 0.00 0 Partners 517 1 1 1.25 1.25 646 Children 0 0 0 0.00 0.00 0 1 Includes 48 volunteers assumed to be pregnant at enrollment 2 Only includes burden for the screening visit Table 5 Estimated burden for pregnancy visits Type of Respondent Estimated Number of Respondents Minimum Number of Responses Maximum Number of Responses Minimum Burden Hours per Response Maximum Burden Hours per Response Estimated Total Burden Hours Women Screened and Enrolled High likelihood of pregnancy 66 4 4 1.50 3.00 486 Moderate likelihood of pregnancy 59 4 4 1.50 3.00 431 Low likelihood of pregnancy 133 4 4 2.00 3.00 1,109 Pregnant at enrollment 1 169 1 4 2.00 3.00 1,063 Enrolled at delivery 0 0 0 0.00 0.00 0 Partners 299 1 1 0.33 1.00 308 Children 0 0 0 0.00 0.00 0 Medical staff 2 33 1 10 0.50 1.00 381 1 Includes 48 volunteers assumed to be pregnant at enrollment 2 The overall burden on medical staff for collection of samples will be shared across a team of staff members, and the overall size of that team is reflected in the " Estimated Number of Respondents" column. 92 Table 6 Estimated burden for birth and childhood visits Type of Respondent Estimated Number of Respondents Minimum Number of Responses Maximum Number of Responses Minimum Burden Hours per Response Maximum Burden Hours per Response Estimated Total Burden Hours Women Screened and Enrolled High likelihood of pregnancy 57 5 5 0.33 2.00 330 Moderate likelihood of pregnancy 50 5 5 0.33 2.00 298 Low likelihood of pregnancy 115 5 5 0.33 2.00 673 Pregnant at enrollment 1 149 5 5 0.33 2.00 871 Enrolled at delivery 35 5 5 0.58 2.00 239 Partners 257 1 1 0.67 0.67 171 Children 406 5 5 0.17 0.50 603 Medical Staff 2 20 1 1 1.50 1.50 518 1 Includes 41 volunteers ( out of 48) who give birth 2 The overall burden on medical staff for collection of samples will be shared across a team of staff members, and the overall size of that team is reflected in the " Estimated Number of Respondents" column. 93 References Final Report for Task 2, Develop a Preliminary Study Plan for Recruitment and Retention with Options for Specific Measures. Prepared by RTI for EPA Work Assignment 03 04, Pilot Cohort Planning and Support.

Pivetz T, Iroz Elardo N, Strauss W, Rust S, Menkedick J. Brief on Estimated Sample Size of Women Needed to Result in 100,000 Live Births ( Revised June 15, 2004). Available at:

http:// www. nationalchildrensstudy. gov/ research/ analytic_ reports/ 94 Appendix C: Questionnaire Instrument Table # Instrument Time of Visit File Name 1 Rostering Script T Q1 NCS Pilot 8.10.05. doc 2 Screening T Q2 NCS Pilot 8.10.05. doc 3 Preconception # 1, Female T + 2 weeks Q3 NCS Pilot 8.10.05. doc 4 Preconception # 1, Partner T + 2 weeks Q4 NCS Pilot 8.10.05. doc 5 Preconception Female and Partner Mental Health Questionnaire T + 2 weeks Q5 NCS Pilot 8.10.05. doc 6 Preconception # 2, Female T + 10 weeks Q6 NCS Pilot 8.10.05. doc 7 Preconception Female Diet Self Administered Questionnaire T + 10 weeks Q7 NCS Pilot 8.10.05. doc 8 Preconception # 3, Female T + 18 weeks Q8 NCS Pilot 8.10.05. doc 9 Preconception # 4, Female T + 26 weeks Q9 NCS Pilot 8.10.05. doc 10 Preconception Telephone Followup Between preconception visits Q10 NCS Pilot 8.10.05. doc 11 Pregnancy # 1, Female ( enrolled during preconception) 1st Trimester Q11 NCS Pilot 8.10.05. doc 12 Pregnancy # 1, Partner ( enrolled during preconception) 1st Trimester Q12 NCS Pilot 8.10.05. doc 13 Pregnancy # 1, Female ( enrolled while pregnant ( 1st trimester), first home visit) 1st Trimester Q13 NCS Pilot 8.10.05. doc 14 Pregnancy # 1, Partner ( enrolled while pregnant ( 1st trimester), first home visit) 1st Trimester Q14 NCS Pilot 8.10.05. doc 15 Pregnancy # 2, Female 2nd Trimester Q15 NCS Pilot 8.10.05. doc 95 # Instrument Time of Visit File Name 16 Pregnancy Female Diet Self Administered Questionnaire 2nd Trimester Q16 NCS Pilot 8.10.05. doc 17 Pregnancy # 3, Female 3rd Trimester Q17 NCS Pilot 8.10.05. doc 18 Pregnancy Female Mental Health Self Administered Questionnaire 3rd Trimester Q18 NCS Pilot 8.10.05. doc 19 Pregnancy Partner Mental Health Self Administered Questionnaire 3rd Trimester Q19 NCS Pilot 8.10.05. doc 20 Female ( Enrolled at delivery, 2nd or 3rd trimester) First Home Visit Child 1 month of age Q20 NCS Pilot 8.10.05. doc 21 Partner ( Enrolled at delivery, 2nd or 3rd trimester) First Home Visit Child 1 month of age Q21 NCS Pilot 8.10.05. doc 22 Post Pregnancy 1 Month Home Visit, Female Child 1 month of age Q22 NCS Pilot 8.10.05. doc 23 Post Pregnancy 6 Month Home Visit, Female Child 6 months of age Q23 NCS Pilot 8.10.05. doc 24 Post Pregnancy 6 Month Home Visit, Partner Child 6 months of age Q24 NCS Pilot 8.10.05. doc 25 Post Pregnancy Female Mental Health Self Administered Questionnaire Child 6 months of age Q25 NCS Pilot 8.10.05. doc 26 Post Pregnancy Partner Mental Health Self Administered Questionnaire Child 6 months of age Q26 NCS Pilot 8.10.05. doc 27 Post Pregnancy 12 Month Home Visit, Female Child 12 months of age Q27 NCS Pilot 8.10.05. doc 28 Post Pregnancy 18 Month Home Visit, Female Child 18 months of age Q28 NCS Pilot 8.10.05. doc 29 New Home Address Questionnaire 1st home visit after relocation Q29 NCS Pilot 8.10.05. doc 30 Medical Event Form Self administered, reported as needed Q30 NCS Pilot 8.10.05. doc


[Federal Register: June 27, 2008 (Volume 73, Number 125)]
[Notices]
[Page 36581-36583]
[DOCID:fr27jn08-110]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58002; File No. SR-Phlx-2008-42]

Self-Regulatory Organizations; Philadelphia Stock Exchange, Inc.;
Notice of Filing and Immediate Effectiveness of a Proposed Rule Change
Relating to Catastrophic Errors

June 23, 2008.
    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 June 17, 2008, the Philadelphia Stock Exchange, Inc. (``Phlx'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I and
II below, which Items have been substantially prepared by the Exchange.
The Exchange filed the proposal as a ``non-controversial'' proposed
rule change pursuant to section 19(b)(3)(A) of the Act \3\ and Rule
19b-4(f)(6) thereunder,\4\ which renders the proposal effective upon
filing with the Commission. 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.
    \3\ 15 U.S.C. 78s(b)(3)(A).
    \4\ 17 CFR 240.19b-4(f)(6).
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    The Phlx proposes to adopt amendments to Exchange Rule 1092
(``Rule'') to: (i) Define a ``Catastrophic Error''; (ii) extend the
time period for member notification to Exchange staff that the member
believes it has participated in a trade that resulted from a
Catastrophic Error; and (iii) state in the Rule that, if the parties to
such a trade do not agree on an adjustment price, trades resulting from
a Catastrophic Error will be adjusted to the Theoretical Price of the
affected option series, plus or minus a pre-determined adjustment
value, depending on the Theoretical Price of the series.
    The text of the proposed rule change is available at the Exchange,
the Commission's Public Reference Room, and http://www.phlx.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 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. Phlx has prepared summaries, set forth in sections A, B,
and C below, of the most significant aspects of such statements.

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

1. Purpose
    The Exchange states that the purpose of the proposed rule change is
to help its members better manage risk by affording them relief from
trades that result from a Catastrophic Error.
    The proposed rule change would address particularly egregious
options trading errors, called Catastrophic Errors. An Options Exchange
Official \5\

would determine that a Catastrophic Error occurred when the execution
price of a transaction is higher or lower than the Theoretical Price
for the series by an amount equal to at least the minimum amount shown
below:
---------------------------------------------------------------------------

    \5\ See Exchange Rules 124(a) and (b).

------------------------------------------------------------------------
                    Theoretical price                     Minimum amount
------------------------------------------------------------------------
Below $2................................................              $1
$2 to $5................................................               2
Above $5 to $10.........................................               5
Above $10 to $50........................................              10
Above $50 to $100.......................................              20
Above $100..............................................              30
------------------------------------------------------------------------

    The proposed rule change would also set forth the procedure to be
followed when an Exchange member believes that he/she has participated
in a trade resulting from a Catastrophic Error. Significantly, the time
period within which such a member would be required to notify the
Exchange's Market Surveillance staff that such an error may have
occurred would be extended well beyond the time period applicable to an
Obvious Error under current Phlx Rule 1092. Members would have until
8:30 a.m. Eastern Time on the first trading day following the date on
which the Catastrophic Error occurred to make such a notification,
except that for such transactions in an expiring options series that
take place on an expiration day, an Exchange member must notify the
Exchange by 5 p.m. Eastern Time that same day.
    If it is determined that a Catastrophic Error has occurred, unless
both (all) parties agree to adjust the transaction to a different
price, the execution price(s) of the transaction(s) will be adjusted to
the theoretical price: (i) Plus the adjustment value provided below for
erroneous buy transactions; and (ii) minus the adjustment value
provided for erroneous sell transactions, as described below:

------------------------------------------------------------------------
                                                              Adjustment
                     Theoretical price                          value
------------------------------------------------------------------------
Below $2...................................................           $1
$2 to $5...................................................            2
Above $5 to $10............................................            3
Above $10 to $50...........................................            5
Above $50 to $100..........................................            7
Above $100.................................................           10
------------------------------------------------------------------------

    The Exchange believes that the proposed longer time period is
appropriate to allow members to discover, and seek relief from, trading
errors that result in extreme losses. At the same time, the Exchange
believes that the proposed Minimum Amounts required for a trade to
qualify as a Catastrophic Error, in combination with the large
Adjustment Values, assures that only those transactions where the price
of the execution results in very high losses will be eligible for
adjustment under the new provisions. While the Exchange believes it is
important to identify and resolve trading errors quickly, it also
believes it is important to the integrity of the marketplace to have
the authority to mitigate extreme losses resulting from errors.
    A member that requests a review under the proposed rule would be
charged $5,000 by the Exchange if there is no adjustment or
nullification of the transaction. The initial ruling by the Options
Exchange Official would be appealable to the Exchange's Referee.\6\
---------------------------------------------------------------------------

    \6\ See Exchange Rule 124, Commentary .02 and current Exchange
Rule 1092(f).
---------------------------------------------------------------------------

    The Exchange states that it has weighed carefully the need to
assure that one market participant is not permitted to receive a
windfall at the expense of another market participant that made an
Obvious Error, against the need to assure that market participants are
not simply being given an opportunity to reconsider poor trading
decisions. The Exchange states that, while it believes that the Obvious
Error Rule strikes the correct balance in most situations, in some
extreme situations, trade participants may not be aware of errors that
result in very large losses within the time periods currently required
under the rule. In this type of extreme situation, the Exchange
believes its members should be given more time to seek relief so that
there is a greater opportunity to mitigate very large losses and reduce
the corresponding large wind-falls. However, to maintain the
appropriate balance, the Exchange believes members should only be given
more time when the execution price is much further away from the
theoretical price than is required for Obvious Errors so that relief is
only provided in extreme circumstances.\7\
---------------------------------------------------------------------------

    \7\ The Exchange does not believe the type of extreme situation
that is covered by the proposed rule would occur in the normal
course of trading. Rather, this type of situation could potentially
occur as a result of, for example, an error in a member's quotation
system that causes a market maker to severely misprice an option.
---------------------------------------------------------------------------

    Under the proposed rule, members will have until 8:30 a.m. Eastern
Time on the trading day following the trade to notify the Exchange of a
potential Catastrophic Error. For trades that take place in an expiring
series on the day of expiration, members must notify the Exchange's
Market Surveillance Department of a potential Catastrophic Error by 5
p.m. Eastern Time that same day. Once a member has notified Market
Surveillance of a potential Catastrophic Error, within the required
time period, an Options Exchange Official would review and make a
determination as to the claim.
2. Statutory Basis
    The Exchange believes that the proposed rule change is consistent
with section 6(b) of the Act,\8\ in general, and furthers the
objectives of section 6(b)(5) of the Act,\9\ in particular, in that it
is designed to promote just and equitable principles of trade, to
remove impediments to and perfect the mechanism of a free and open
market and a national market system, and, in general to protect
investors and the public interest, by helping Exchange members better
manage risk through the Catastrophic Error rule. In particular, the
proposal would allow members a longer opportunity to seek relief from
errors that result in large losses.
---------------------------------------------------------------------------

    \8\ 15 U.S.C. 78f(b).
    \9\ 15 U.S.C. 78f(b)(5).
---------------------------------------------------------------------------

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

    The Exchange does not believe that the proposed rule change would
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

    The Exchange has neither solicited nor received written comments on
the proposed rule change.

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

    Because the proposed rule change does not: (i) Significantly affect
the protection of investors or the public interest; (ii) impose any
significant burden on competition; and (iii) become operative for 30
days after the date of filing (or such shorter time as the Commission
may designate if consistent with the protection of investors and the
public interest), the proposed rule change has become effective
pursuant to section 19(b)(3)(A) of the Act \10\ and subparagraph (f)(6)
of Rule 19b-4 thereunder.\11\
---------------------------------------------------------------------------

    \10\ 15 U.S.C. 78s(b)(3)(A).
    \11\ 17 CFR 240.19b-4(f)(6).
---------------------------------------------------------------------------

    A proposed rule change filed under Rule 19b-4(f)(6) normally does
not become operative prior to 30 days after the date of filing.\12\
However, Rule 19b-4(f)(6)(iii) permits the Commission to

designate a shorter time if such action is consistent with the
protection of investors and the public interest. The Exchange has
requested that the Commission waive the 30-day operative delay and
designate the proposed rule change operative upon filing. The
Commission believes that waiving the 30-day operative delay is
consistent with the protection of investors and the public interest.
Given that the Exchange's proposed catastrophic error rule is
substantially similar to that of the International Securities Exchange
and that of NYSE Arca,\13\ the proposal does not appear to present any
novel regulatory issues. Therefore, the Commission designates the
proposal operative upon filing.\14\
---------------------------------------------------------------------------

    \12\ 17 CFR 240.19b-4(f)(6)(iii). The Exchange has satisfied the
five-day pre-filing requirement of Rule 19b-4(f)(6)(iii).
    \13\ See Securities Exchange Act Release Nos. 57398 (February
28, 2008), 73 FR 12240 (March 6, 2008) (SR-ISE-2007-112) and 57653
(April 11, 2008), 73 FR 20996 (April 17, 2008) (SR-NYSEArca-2008-
41).
    \14\ For purposes only of waiving the operative delay of this
proposal, the Commission has considered the proposed rule's impact
on efficiency, competition, and capital formation. 15 U.S.C. 78c(f).
---------------------------------------------------------------------------

    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 the 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-Phlx-2008-42 on the subject line.

Paper Comments

     Send paper comments in triplicate to Secretary, Securities
and Exchange Commission, 100 F Street, NE., Washington, DC 20549-1090.
All submissions should refer to File Number SR-Phlx-2008-42. 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 available publicly. All submissions
should refer to File Number SR-Phlx-2008-42 and should be submitted on
or before July 18, 2008.
---------------------------------------------------------------------------

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

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\15\
Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-14566 Filed 6-26-08; 8:45 am]

BILLING CODE 8010-01-P


[Federal Register: June 3, 2009 (Volume 74, Number 105)]
[Notices]
[Page 26670-26671]
[DOCID:fr03jn09-46]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

[Project No. 12576-004]

CRD Hydroelectric, LLC; Notice of Application Accepted for Filing
and Soliciting Motions To Intervene and Protests

May 27, 2009.
    Take notice that the following hydroelectric application has been
filed with the Commission and is available for public inspection.
    a. Type of Application: Original License.
    b. Project No.: 12576-004.
    c. Date Filed: February 24, 2009.
    d. Applicant: CRD Hydroelectric, LLC.
    e. Name of Project: Red Rock Hydroelectric Project.
    f. Location: On the Des Moines River, in Marion County, Iowa. The
project would be located at U.S. Army Corps of Engineer facilities.
    g. Filed Pursuant to: Federal Power Act 16 U.S.C. 791(a)-825(r).
    h. Applicant Contact: Mr. Douglas A. Spaulding, Nelson Energy LLC,
8441 Wayzata Blvd., Suite 101, Golden Valley, MN 55426;<PHONE_NUMBER>.
    i. FERC Contact: Timothy Konnert,<PHONE_NUMBER> or
<EMAIL_ADDRESS>    j. Deadline for filing motions to intervene and protests: 60 days
from the issuance date of this notice.
    All documents (original and eight copies) should be filed with:
Kimberly D. Bose, Secretary, Federal Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426.
    The Commission's Rules of Practice require all intervenors filing
documents with the Commission to serve a copy of that document on each
person on the official service list for the project. Further, if an
intervenor files comments or documents with the Commission relating to
the merits of an issue that may affect the responsibilities of a
particular resource agency, they must also serve a copy of the document
on that resource agency.
    Motions to intervene and protests may be filed electronically via
the Internet in lieu of paper. The Commission strongly encourages
electronic filings. See 18 CFR 385.2001(a)(1)(iii) and the instructions
on the Commission's Web site (http://www.ferc.gov) under the ``e-
Filing'' link.
    k. This application has been accepted, but is not ready for
environmental analysis at this time.
    l. The proposed Red Rock Hydroelectric Project would be located at
the existing U.S. Army Corps of Engineers (Corps) Red Rock dam, which
was constructed by the Corps in 1969 for flood control. The existing
Corps facilities consist of: (1) A 110-foot-high, 6,260-foot-long
earth-fill dam with a 241-foot-long gated ogee spillway equipped with
five 45-foot-high tainter gates; and (2) a 15,253-acre reservoir at a
normal conservation pool water surface elevation of 742.0 feet National
Geodetic Vertical Datum of 1929.
    The proposed project would utilize the head created by the existing
Corps dam and consist of: (1) A new, 127-foot-long by 19-foot-wide
intake structure connected to; (2) three new 19-foot-diameter, 211-
foot-long penstocks passing through the left side of the spillway
leading to; (3) a new 59-foot-long by 132-foot-wide powerhouse located
directly downstream of the existing spillway structure containing three
new 12.13-megawatt (MW) generating units with a total installed
capacity of 36.4 MW; (4) a new 8.4-mile-long, 69-kilovolt transmission
line; and (5) appurtenant facilities. The estimated average annual
generation would be 158,000 megawatt hours.
    The project would be operated in run-of-river mode in that it would
have no storage and only use flows released by the Corps in accordance
with its present operations.
    m. A copy of the application is available for review at the
Commission in the Public Reference Room or may 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 field to
access the document. For assistance, contact FERC Online Support at
<EMAIL_ADDRESS>or toll-free at 1-866-208-3676, or for TTY,
(202) 502-8659. A copy is also available for inspection and
reproduction at the address in item h above.
    You may also register online at http://www.ferc.gov/docs-filing/
esubscription.asp to be notified via e-mail of new filings and
issuances related to this or other pending projects. For assistance,
contact FERC Online Support.
    n. Anyone may submit a protest or a motion to intervene in
accordance with the requirements of Rules of Practice and Procedure, 18
CFR 385.210, 385.211, and 385.214. In determining the appropriate
action to take, the Commission will consider all protests filed, but
only those who file a motion to intervene in accordance with the
Commission's Rules may become a party to the proceeding. Any protests
or motions to intervene must be received on or before the specified
deadline date for the particular application.
    All filings must (1) bear in all capital letters the title
``PROTEST'' or ``MOTION TO INTERVENE;'' (2) set forth in the heading
the name of the applicant and the project number of the application to
which the filing responds; (3) furnish the name, address, and telephone
number of the person protesting or intervening; and (4) otherwise
comply with the requirements of 18 CFR 385.2001 through 385.2005.
Agencies may obtain copies of the application directly from the
applicant. A copy of any protest or motion to intervene must be served
upon each representative of the applicant specified in the particular
application.
    o. Procedural Schedule: The application will be processed according
to the following Hydro Licensing Schedule. Revisions to the schedule
will be made as appropriate.

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

------------------------------------------------------------------------
Issue Scoping Document.................  October 2009.
Notice of application is ready for       January 2010.
 environmental analysis.
Notice of the availability of the EA...  November 2010.
------------------------------------------------------------------------

Kimberly D. Bose,
Secretary.
[FR Doc. E9-12868 Filed 6-2-09; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 77, Number 25 (Tuesday, February 7, 2012)]
[Proposed Rules]
[Pages 6042-6044]
[FR Doc No: 2012-2789]

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DEPARTMENT OF HOMELAND SECURITY

Coast Guard

33 CFR Part 117

[Docket No. USCG-2011-1136]
RIN 1625-AA09

Drawbridge Operation Regulation; Christina River, Wilmington, DE

AGENCY: Coast Guard, DHS.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Coast Guard proposes to change the regulations that govern
the operation of the Norfolk Southern Railroad Bridges over the
Christina River at miles 4.1 and 4.2, both in Wilmington, DE. Since
there have been no recorded requests for vessel openings in more than
20 years for either bridge, this proposal would change the current
regulations by allowing the drawbridge, at mile 4.1, to be maintained
in the closed position to navigation and the drawbridge, at mile 4.2,
to be left in the open-to-navigation position.

DATES: Comments and related material must reach the Coast Guard on or
before March 23, 2012.

ADDRESSES: You may submit comments identified by docket number USCG-
2011-1136 using any one of the following methods:
    (1) Federal eRulemaking Portal: http://www.regulations.gov.
    (2) Fax:<PHONE_NUMBER>.
    (3) Mail: Docket Management Facility (M-30), U.S. Department of
Transportation, West Building Ground Floor, Room W12-140, 1200 New
Jersey Avenue SE., Washington, DC, 20590-0001.
    (4) Hand delivery: Same as mail address above, between 9 a.m. and 5
p.m., Monday through Friday, except Federal holidays. The telephone
number is<PHONE_NUMBER>.
    To avoid duplication, please use only one of these four methods.
See the ``Public Participation and Request for Comments'' portion of
the SUPPLEMENTARY INFORMATION section below for instructions on
submitting comments.

FOR FURTHER INFORMATION CONTACT: If you have questions on this proposed
rule, call or email Terrance Knowles, Coast Guard; telephone (757) 398-
6587, email<EMAIL_ADDRESS>If you have questions on
viewing or submitting material to the docket, call Renee V. Wright,
Program Manager, Docket Operations, telephone<PHONE_NUMBER>.

SUPPLEMENTARY INFORMATION:

Public Participation and Request for Comments

    We encourage you to participate in this rulemaking by submitting
comments and related materials. All comments received will be posted,
without change to http://www.regulations.gov and will include any
personal information you have provided.

Submitting Comments

    If you submit a comment, please include the docket number for this
rulemaking (USCG-2011-1136), indicate the specific section of this
document to which each comment applies, and provide a reason for each
suggestion or recommendation. You may submit your comments and material
online (http://www.regulations.gov), or by fax, mail or hand delivery,
but please use only one of these means. If you submit a comment online
via http://www.regulations.gov, it will be considered received by the
Coast Guard when you successfully transmit the comment. If you fax,
hand deliver, or mail your comment, it will be considered as having
been received by the Coast Guard when it is received at the Docket
Management Facility. We recommend that you include your name and a
mailing address, an email address, or a phone number in the body of
your document so that we can contact you if we have questions regarding
your submission.
    To submit your comment online, go to http://www.regulations.gov,
click on the ``submit a comment'' box, which will then become
highlighted in blue. In the ``Document Type'' drop down menu select
``Proposed Rules'' and insert ``USCG-2011-1136'' in the ``Keyword''
box. Click ``Search'' then click on the balloon shape in the
``Actions'' column. If you submit your comments by mail or hand
delivery, submit them in an unbound format, no larger than 8\1/2\; by
11 inches, suitable for copying and electronic filing. If you submit
them by mail and would like to know that they reached the Facility,
please enclose a stamped, self-addressed postcard or envelope. We will
consider all comments and material received during the comment period
and may change the rule based on your comments.

Viewing Comments and Documents

    To view comments, as well as documents mentioned in this preamble
as being available in the docket, go to http://www.regulations.gov,
click on the ``read comments'' box, which will then

become highlighted in blue. In the ``Keyword'' box insert ``USCG-2011-
1136'' and click ``Search.'' Click the ``Open Docket Folder'' in the
``Actions'' column. You may also visit the Docket Management Facility
in Room W12-140 on the ground floor of the Department of Transportation
West Building, 1200 New Jersey Avenue SE., Washington, DC, 20590,
between 9 a.m. and 5 p.m., Monday through Friday, except Federal
holidays. We have an agreement with the Department of Transportation to
use the Docket Management Facility.

Privacy Act

    Anyone can search the electronic form of comments received into any
of our dockets by the name of the individual submitting the comment (or
signing the comment, if submitted on behalf of an association,
business, labor union, etc.). You may review a Privacy Act notice
regarding our public dockets in the January 17, 2008, issue of the
Federal Register (73 FR 3316).

Public Meeting

    We do not now plan to hold a public meeting. But you may submit a
request for one using one of the four methods specified under
ADDRESSES. Please explain why one would be beneficial. If we determine
that one would aid this rulemaking, we will hold one at a time and
place announced by a later notice in the Federal Register.

Basis and Purpose

    Norfolk Southern Corporation (NS), who owns and operates both
swing-type bridges, has requested changes in the operating regulations
of their railroad drawbridges across Christina River, at miles 4.1 and
4.2, in Wilmington, DE, set out in 33 CFR 117.237(d).
    The NS drawbridges at miles 4.1 and 4.2 have vertical clearances in
the closed position to vessels of six and three feet above mean high
water, respectively.
    Under the regular operating schedule, the drawbridges shall open on
signal from 6 a.m. to 8 p.m., if at least 24 hours notice is given; and
from 8 p.m. to 6 a.m., the draws need not be opened for the passage of
vessels.
    There had been no request to open either drawbridge for a vessel
for more than 20 years. Approximately two trains per day traverse the
NS drawbridge at mile 4.1, and there is no train service at the NS
drawbridge at mile 4.2, where the bridge is currently placed in the
open-to-navigation position. In accordance with 33 CFR 117.39 and
117.41, the Coast Guard proposes to allow the NS drawbridge at mile 4.1
to be maintained in the closed-to-navigation position; and allow the NS
drawbridge at mile 4.2 to be maintained in the open-to-navigation
position and discontinue draw tender service for both drawbridges. The
24-hour advance notice in the current regulation is no longer necessary
due to the lack of openings.

Discussion of Proposed Rule

    The Coast Guard proposes to revise 33 CFR 117.237(d). This proposed
change would divide the current paragraph into paragraphs (d)(1) and
(d)(2).
    Paragraph (d)(1) would contain the proposed rule for the Norfolk
Southern Railroad Bridge at mile 4.1. The rule would allow the draw of
the bridge to remain in the closed-to-navigation position and would not
require openings for the passage of vessels.
    Paragraph (d)(2) would contain the proposed rule for the Norfolk
Southern Railroad Bridge at mile 4.2. The rule would allow the draw of
the bridge to be maintained in the open-to-navigation position and
would allow for unobstructed passage of vessels.

Regulatory Analyses

    We developed this proposed rule after considering numerous statutes
and executive orders related to rulemaking. Below we summarize our
analyses based on 13 of these statutes or executive orders.

Regulatory Planning and Review

    This proposed rule is not a ``significant regulatory action'' under
section 3(f) of Executive Order 12866, Regulatory Planning and Review,
as supplemented by Executive Order 13563, Improving Regulation and
Regulatory Review, and does not require an assessment of potential
costs and benefits under section 6(a)(3) of that Executive Order 12866.
The Office of Management and Budget has not reviewed it under that
Order. The proposed change is expected to have minimal impact on
mariners since there have been no requests for vessel openings for more
than 20 years for either drawbridge with no anticipated change to
vessel traffic.

Small Entities

    Under the Regulatory Flexibility Act (5 U.S.C. 601-612), we have
considered whether this proposed rule would have a significant economic
impact on a substantial number of small entities. The term ``small
entities'' comprises small businesses, not-for-profit organizations
that are independently owned and operated and are not dominant in their
fields, and governmental jurisdictions with populations of less than
50,000.
    The Coast Guard certifies under 5 U.S.C. 605(b) that this proposed
rule would not have a significant economic impact on a substantial
number of small entities. This action will not have a significant
economic impact on a substantial number of small entities for the
following reasons. There have been no requests to open either
drawbridge for the passage of vessels for more than 20 years and there
is no anticipated change to vessel traffic.
    If you think that your business, organization, or governmental
jurisdiction qualifies as a small entity and that this rule would have
a significant economic impact on it, please submit a comment (see
ADDRESSES) explaining why you think it qualifies and how and to what
degree this rule would economically affect it.

Assistance for Small Entities

    Under section 213(a) of the Small Business Regulatory Enforcement
Fairness Act of 1996 (Pub. L. 104-121), we want to assist small
entities in understanding this proposed rule so that they can better
evaluate its effects on them and participate in the rulemaking. If the
rule would affect your small business, organization, or governmental
jurisdiction and you have questions concerning its provisions or
options for compliance, please contact Terrance Knowles, Environmental
Protection Specialist, Fifth Coast Guard District,<PHONE_NUMBER> or
email<EMAIL_ADDRESS>The Coast Guard will not retaliate
against small entities that question or complain about this proposed
rule or any policy or action of the Coast Guard.

Collection of Information

    This proposed rule would call for no new collection of information
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520.).

Federalism

    A rule has implications for federalism under Executive Order 13132,
Federalism, if it has a substantial direct effect on State or local
governments and would either preempt State law or impose a substantial
direct cost of compliance on them. We have analyzed this proposed rule
under that Order and have determined that it does not have implications
for federalism.

Unfunded Mandates Reform Act

    The Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1531-1538)
requires Federal agencies to assess the effects of their discretionary
regulatory actions. In

particular, the Act addresses actions that may result in the
expenditure by a State, local, or tribal government, in the aggregate,
or by the private sector of $100,000,000 (adjusted for inflation) or
more in any one year. Though this proposed rule will not result in such
expenditure, we do discuss the effects of this rule elsewhere in this
preamble.

Taking of Private Property

    This proposed rule would not cause a taking of private property or
otherwise have taking implications under Executive Order 12630,
Governmental Actions and Interference with Constitutionally Protected
Property Rights.

Civil Justice Reform

    This proposed rule meets applicable standards in sections 3(a) and
3(b)(2) of Executive Order 12988, Civil Justice Reform, to minimize
litigation, eliminate ambiguity, and reduce burden.

Protection of Children

    We have analyzed this proposed rule under Executive Order 13045,
Protection of Children from Environmental Health Risks and Safety
Risks. This rule is not an economically significant rule and would not
create an environmental risk to health or risk to safety that might
disproportionately affect children.

Indian Tribal Governments

    This proposed rule does not have tribal implications under
Executive Order 13175, Consultation and Coordination with Indian Tribal
Governments, because it would not have a substantial direct effect on
one or more Indian tribes, on the relationship between the Federal
Government and Indian tribes, or on the distribution of power and
responsibilities between the Federal Government and Indian tribes.

Energy Effects

    We have analyzed this proposed rule under Executive Order 13211,
Actions Concerning Regulations That Significantly Affect Energy Supply,
Distribution, or Use. We have determined that it is not a ``significant
energy action'' under that order because it is not a ``significant
regulatory action'' under Executive Order 12866 and is not likely to
have a significant adverse effect on the supply, distribution, or use
of energy. The Administrator of the Office of Information and
Regulatory Affairs has not designated it as a significant energy
action. Therefore, it does not require a Statement of Energy Effects
under Executive Order 13211.

Technical Standards

    The National Technology Transfer and Advancement Act (NTTAA) (15
U.S.C. 272 note) directs agencies to use voluntary consensus standards
in their regulatory activities unless the agency provides Congress,
through the Office of Management and Budget, with an explanation of why
using these standards would be inconsistent with applicable law or
otherwise impractical. Voluntary consensus standards are technical
standards (e.g., specifications of materials, performance, design, or
operation; test methods; sampling procedures; and related management
systems practices) that are developed or adopted by voluntary consensus
standards bodies.
    This proposed rule does not use technical standards. Therefore, we
did not consider the use of voluntary consensus standards.

Environment

    We have analyzed this proposed rule under Department of Homeland
Security Management Directive 023-01, and Commandant Instruction
M16475.lD which guides the Coast Guard in complying with the National
Environmental Policy Act of 1969 (NEPA) (42 U.S.C. 4321-4370f), and
have made a preliminary determination that this action is one of a
category of actions which do not individually or cumulatively have a
significant effect on the human environment because it simply
promulgates the operating regulations or procedures for drawbridges. We
seek any comments or information that may lead to the discovery of a
significant environmental impact from this proposed rule.

List of Subjects in 33 CFR Part 117

    Bridges.

    For the reasons discussed in the preamble, the Coast Guard proposes
to amend 33 CFR part 117 as follows:

PART 117--DRAWBRIDGE OPERATION REGULATIONS

    1. The authority citation for part 117 continues to read as
follows:

    Authority: 33 U.S.C. 499; 33 CFR 1.05-1; Department of Homeland
Security Delegation No. 0170.1.

    2. Revise paragraph Sec.  117.237(d) to read as follows:

Sec.  117.237  Christina River

* * * * *
    (d) The following drawbridges at Wilmington shall operate as
follows:
    (1) The Norfolk Southern Railroad Bridge, mile 4.1, shall be
maintained in the closed-to-navigation position;
    (2) The Norfolk Southern Railroad Bridge, mile 4.2, shall be
maintained in the open-to-navigation position.
* * * * *

    Dated: January 12, 2012.
William D. Lee,
Rear Admiral, U.S. Coast Guard, Commander, Fifth Coast Guard District.
[FR Doc. 2012-2789 Filed 2-6-12; 8:45 am]
BILLING CODE 4910-15-P