FINAL REPORT BIOLOGICAL CHARACTERISTICS OF NEARSHORE FISHES OF CALIFORNIA: A REVIEW OF EXISTING KNOWLEDGE AND PROPOSED ADDITIONAL STUDIES FOR THE PACIFIC OCEAN INTERJURISDICTIONAL FISHERIES MANAGEMENT PLAN COORDINATION AND DEVELOPMENT PROJECT SUBMITTED TO MR. AL DIDIER PACIFIC STATES MARINE FISHERIES COMMISSION AUGUST 31, 2000 PRINCIPAL INVESTIGATOR:

Dr. Gregor M. Cailliet, Professor Moss Landing Marine Laboratories 8272 Moss Landing Road Moss Landing, California 95039 ( 831) 632 4432; fax ( 831) 632 4403 cailliet@ mlml. calstate. edu MLML RESEARCH STAFF:

Erica J. Burton, Project Leader; burton@ mlml. calstate. edu Jason M. Cope, Graduate Research Assistant; jcope@ mlml. calstate. edu Lisa A. Kerr, Graduate Research Assistant; lkerr@ mlml. calstate. edu Moss Landing Marine Laboratories 8272 Moss Landing Road Moss Landing, California 95039 ( 831) 632 4419; fax ( 831) 632 4403 CO INVESTIGATORS:

Dr. Ralph J. Larson, Professor Dr. Robert N. Lea Department of Biology California Department of Fish and Game San Francisco State University 20 Lower Ragsdale Drive, Suite 100 San Francisco, California 94132 Monterey, California 93940 ( 415) 338 1027 ( 831) 649 2835; fax ( 831) 649 2894 rlars@ sfsu. edu rlea@ dfg. ca. gov Mr. David VenTresca Mr. Eric Knaggs California Department of Fish and Game California Department of Fish and Game 20 Lower Ragsdale Drive, Suite 100 20 Lower Ragsdale Drive, Suite 100 Monterey, California 93940 Monterey, California 93940 ( 831) 649 2881; fax ( 831) 649 2894 ( 831) 649 7193; fax ( 831) 649 2894 dventres@ dfg. ca. gov ehknaggs@ dfg. ca. gov FINAL REPORT 31 AUGUST 2000 2 PROJECT SUMMARY As part of the recent Marine Life Management Act, the California Department of Fish and Game is required to produce a Fishery Management Plan for the nearshore region as described in the Nearshore Fisheries Management Act. This requires the compilation of a species list that includes the species of fishes for which size limits are prescribed in the Act and other vulnerable species, and a detailed analysis of existing knowledge of the life history ( age, growth, age at maturity, age composition, habitat utilization, reproduction, recruitment, trophic relationships, population health, and stock structure, including genetics) of nearshore fish species, especially those subject to the newly developing live fish ( premium) fishery. During this project, we compiled a list of species currently taken in the nearshore fishery and others that could be particularly vulnerable ( n= 124). In addition, we created a life history parameter questionnaire to guide our literature search and compilation of life history parameters, surveyed the existing literature, constructed a life history database of the nearshore fish species list, and compiled a literature cited document. General gaps in the existing knowledge are identified, and specific research projects are proposed on such subjects as age at maturity, age validation, reproduction, trophic interactions, genetic variance, and mobility of fish stocks subject to the nearshore fisheries of California. It is hoped that this project will result in additional support to answer questions that will provide management agencies with sufficient information to effectively manage this fishery.

BACKGROUND The 1998 Keeley Bill ( AB 1241), which is now law as the Marine Life Management Act ( MLMA), has several requirements, including size limits for selected species, and status reports and Fishery Management Plans ( FMPs) to be prepared by the California Department of Fish and Game ( CDFG) for important commercial and sport fishery species in California. Funding has been made available from the Pacific States Marine Fisheries Commission ( PSMFC) to support a research institution ( Moss Landing Marine Labs, MLML) to complement the work CDFG is doing on this subject.

Nearshore fisheries have existed in California for decades ( Lea et al. 1999), but a recent fishery for live fish that are used in the restaurant business and shipped overseas, started in southern California in the late 1980s, spread to northern California in the early 1990s, and now has become common in central California ( McKee Lewis 1996). The fishery uses gear ranging from hook and line to pole fishing and traps. The landings of live finfish in California have exhibited an exponential increase from ~ 20,000 to 1,200,000 pounds in the past 7 years, and were worth from ~ $ 20,000 to $ 1,300,000. The number of species landed in this fishery range from ~ 5 to > 50, depending upon location, season, and year. Even though some reports of landings and the status of this fishery exist ( CDFG 1998, Starr et al. 1998) much information is still needed.

The role of life histories in this nearshore fishery has not yet been evaluated. Could the live fish fishery be doomed to failure because it targets mainly on small, immature specimens of shallow, nearshore fishes, some of which are not targeted in any other way? Certainly, fisheries for FINAL REPORT 31 AUGUST 2000 3 juvenile fishes, especially if they target all areas where these juveniles live, cannot last long. The large and increasing numbers of fishes being harvested before most get a chance to reproduce for the first time is of particular concern regarding the live fish fishery. Since rockfish are typically long lived, often take many years to mature ( Echeverria 1987, Love and Johnson 1998, Lea et al. 1999), and are known to have highly variable, successful recruitment ( Karpov et al. 1995), harvesting most individuals before they mature and reproduce can be disastrous for their populations and ultimately the ecosystem.

The live fish fishery targets on sizes and species of fishes that were not heavily fished prior to now ( Lea et al. 1999). It is known that many of these nearshore fishes are very site intensive. Thus, any heavy fishing on their populations, most of which have either home sites or territories and do not move much after settling, could be very deleterious to the local population densities.

In June 1999, the University of California Sea Grant Marine Advisory Program and CDFG sponsored a Workshop on Assessing and Managing Nearshore Fisheries in Santa Barbara. Many fishery biologists attended this useful workshop and produced numerous recommendations, including the need to obtain the best possible data on catch, effort, species and size composition, reproduction, maturity, location, site specificity, larval dispersal and recruitment, and socioeconomic variables to enable CDFG to evaluate the trends in this increasing fishery.

WORK ACCOMPLISHED The results from this project will be a major step toward characterizing the fish assemblages in California's nearshore ocean waters and providing essential information for measuring the impacts of human activities, measuring economic costs and benefits to the state from commercial and recreational fishing, and evaluating alternative management strategies for marine fisheries through the FMP process. These results are expected to enhance the quality, availability, and consistency of life history data used in CDFG management decisions, and to make these data available to the public and other government or private academic institutions. This research will complement a separate state funded nearshore marine Geographic Information System ( GIS) project to start mapping nearshore sedimentary and rocky habitats in 0 30 meters off California and classify these bathymetric habitats and their species associations.

A. ANALYSIS AND SUMMARY OF EXISTING LIFE HISTORY PARAMETERS The most recent analyses of the knowledge of the life histories of and status of fisheries for species taken in the nearshore fishery was accomplished by Leet et al. ( 1992) for California and by Starr et al. ( 1998) and Lea et al. ( 1999) for central California. Much information about life histories of these species is scattered about the published literature, as well as contained in state and federal agency reports that have not been published in refereed journals or made publicly available. The MLMA has specific size limits for a select group of fish species targeted by the live fish fishery, yet an examination of the published literature on these species does not provide age estimates and reproductive maturity information that supports all of these size limits. Therefore, a review and compilation of the existing information is imperative. FINAL REPORT 31 AUGUST 2000 4 1) Species List The first objective was to produce a list of the species now taken in the nearshore fisheries of California. This list includes the species listed in the MLMA, but also includes species frequently caught that are not on this size limit list and those which could be particularly vulnerable. Among personnel at MLML and Bob Lea from CDFG, we decided on a list of species having some or one of the following criteria: 1) occurring in 40 fathoms or less; 2) listed in the MLMA; 3) listed in McKee Lewis ( 1996); 4) common in the sport fishery; 5) common as bait fish; 6) common in public aquaria or the aquaria trade; 7) common as bycatch and prone to overfishing; or 8) marketed incorrectly and possibly prone to overfishing. These criteria could, of course, include almost all of the nearshore fishes off the coast of California. Therefore, our species list was subjectively honed down from > 239 to 124 species ( 42 families); a relatively reasonable number of species to survey during this 8 month project ( Table 1).

2) Literature Survey The second objective was to survey the existing published literature on those subjects recently included in the Fisheries Management Plan ( FMP) and Biological Information Catalog system being developed by David VenTresca ( CDFG, Monterey). Life history subjects in our survey include, but are not limited to, age and growth ( length/ weight/ age relationships, growth parameters, longevity, age composition); spawning and reproductive status ( parturition period, size/ age at sexual maturation, fecundity); recruitment ( size at settlement, recruitment to fisheries); population or stock genetics; mortality estimates ( natural, fishing, total); specieshabitat associations; trophic interactions ( feeding, predation); and behavior ( competition, movements, home ranges). We constructed a LIFE HISTORY QUESTIONNAIRE ( APPENDIX A) to guide our literature search, and used this questionnaire to compile life history parameters into a FLAT DATABASE ( MICROSOFT   EXCEL WORKBOOK: LIFE_ HISTORIES. XLS).

3) Database Format To read, understand, and utilize the database and its format, the LIFE HISTORY QUESTIONNAIRE ( APPENDIX A) should be used while viewing the database. The FLAT DATABASE is composed of 32 MICROSOFT   EXCEL WORKSHEETS within a SINGLE WORKBOOK ( LIFE_ HISTORIES. XLS). Worksheets are organized by family name or species group ( elasmobranchs and flatfishes only). Within a spreadsheet, species are listed in rows within column B ( Scientific name). Life history parameter categories are listed at the top of the spreadsheet( s) from left to right ( following the order of the LIFE HISTORY QUESTIONNAIRE, APPENDIX A), columns A thru DG ( or DH, in some cases). Life history information is then contained within spreadsheet cells. Abbreviations used in the database are listed at the end of APPENDIX A. The literature source for each life history parameter is listed at the bottom of each column. Therefore, the citations are column specific, and are footnoted accordingly ( i. e. renumbered for each column). The corresponding literature can be found in the LITERATURE CITED document ( APPENDIX B), where citations are alphabetized. FINAL REPORT 31 AUGUST 2000 5 In some cases, life history categories are related; therefore, information is listed across a single row ( encompassing several columns). For example, the " von Bertalanffy Growth Parameters " section within " Age and Growth" encompasses several columns ( from " Geographic Area" to " Verification"); and data within one row ( across 16 columns) will refer to one study. Other similar formats are found in the " Maturity," " Fertilization and Spawning Period," " Habitat Association & Trophic Interactions," " Genetic Variance," " Recruitment Into Fishery," and " Mortality" sections. Other columns stand alone, and footnoted citations may not correspond across a row, from column to column.

B. IDENTIFICATION OF GAPS IN THE EXISTING KNOWLEDGE OF LIFE HISTORY PARAMETERS FOR NEARSHORE FISH SPECIES The database serves not only as an information source, but also serves to identify where information is lacking. To clarify and identify true gaps in the literature, three abbreviations were used where information was not provided: 1) NA, not applicable; 2) NG, not given; or 3) NF, not found. Not applicable ( NA) refers to a life history parameter that is not valid for a species ( e. g. egg stage not applicable for embiotocids). Not given ( NG) refers to a study where similar life history parameters are provided within a section of the survey, but not for the specified parameter ( e. g. an age and growth study where von Bertalanffy growth parameters are provided for males and females but not for the sexes combined; or a maturity study with age at first maturity but not age at 50% maturity). Not found ( NF) refers to a parameter where no information was found; either it does not exist, or we did not find the information. Therefore an empty space or cell does not mean a lack of information, rather a space for formatting.

There are many gaps in the existing life history literature of California's nearshore fishes. In general, the following life history information is lacking for most species: 1) age validation and growth studies, 2) fecundity estimates, 3) measures of genetic variance, 4) size and age at settlement, 5) mortality estimates, 6) recruitment to the fishery, and 7) movement.

Large gaps in the existing knowledge of life history parameters occur primarily for elasmobranchs, and for the families Cottidae, Hexagrammidae, Muraenidae, Anoplopomatidae, Sphyraenidae, Pleuronectidae, Bothidae, Polyprionidae, Carangidae, Anarhichadidae, Scorpaenidae ( several species), and Embiotocidae ( especially age validation). Several specific gaps are identified below in Part C.

C. ADDITIONAL STUDIES ON THE LIFE HISTORY OF NEARSHORE FISHES Following Goals A and B, we are pursuing our third goal, much of which will comprise the bulk of the funding we have requested from PSMFC for 2000 2001, which will be to continue some of the research that we initiated in the first year's project and to add several other interesting and important projects. FINAL REPORT 31 AUGUST 2000 6 1) Age and Growth, Longevity, and Age at First Maturity of Selected MLMA/ NFMA Species The first objective will be to initiate age and growth, reproduction, and age at maturity studies on some of the species for which there is uncertainty about the relationship between MLMA size limits and verified or validated estimates of age. Our literature review this year indicated that some of the size limits did not agree well with existing knowledge of the age at first maturity for some species. To determine how vulnerable some of the nearshore fish stocks are to exploitation, an idea of their longevity, based on these proposed validated age and growth studies and coupled with better estimates of natural and fishing mortality and fecundity of older/ larger age classes, will result in better information for nearshore fishery management.

One of the species that requires the most urgent attention is the cabezon ( Scorpaenichthys marmoratus), which despite being quite abundant and popular in historic recreational fisheries, has not been very thoroughly studied, especially in California ( O'Connell 1953; Lauth 1987, 1988). We propose to concentrate on age and growth studies that utilize more modern techniques that involve sectioning, and we will conduct marginal increment analysis to validate the growth, age at maturity, and longevity of this important nearshore species. To determine length at maturity, the size and degree of maturity of the gonads will be examined throughout the year. Cabezon are being collected from northern and southern California to determine if differences exist between fish from these two geographic areas. These data will provide valuable information for fishery management.

Other species ( see list below under genetics and demography) will be studied in next year's PSMFC project, and will concentrate on age, growth, reproduction and age at maturity studies. Inclusion of additional species in this list will depend upon the samples available and the graduate student's interest in them as thesis material.

Dr. Ralph Larson ( SFSU) and his graduate students analyzed existing and newly collected samples of otoliths and morphometric data from kelp rockfish ( Sebastes atrovirens) and black and yellow rockfish ( S. chrysomelas) as part of their on going studies of age and growth of these two species.

2) Genetics and Demography A comparative life history study of blue rockfish ( Sebastes mystinus) subpopulations will be performed at five sites along California: 1) Santa Barbara mainland, 2) San Miguel Island, 3) central California ( Big Creek or Monterey Bay), 4) the Farallon Islands, and 5) northern California ( Mendocino or Bodega Bay). Genetic analyses of tissue samples, using the control region ( D loop) of mitochondrial DNA, will be used to measure genetic variance and population substructure among geographic sites. In addition, a stage based ( larvae, pelagic juvenile, settled juvenile, and adult) stochastic demographic model will be produced using age and growth information, adult mortality ( estimated from VBGF parameters and gonadal indices), age at first maturity, and longevity estimates from each geographic area. This model will provide vital statistics   such as intrinsic rates of increase and rebound potentials   for each subpopulation ( Caswell 1989, Au and Smith 1997). FINAL REPORT 31 AUGUST 2000 7 The combination of both genetic and demographic measures of each subpopulation will allow a better understanding of population " health," adaptability, and longevity ( Lacy 1987, Lande 1988, Nunney 1992, Soltis et al. 1999). This unique combination will also provide insight into nearshore rockfish genetic relatedness in the California Current and the effectiveness of marine reserves to protect residential nearshore species with long larval durations. This approach will be a further attempt to formulate an index, which may be comparable across taxa and populations.

The blue rockfish was chosen as the model species to represent the nearshore rockfish complex, because sufficient samples are obtainable; whereas, local population depletions and the solitary nature of other species ( S. atrovirens, S. auriculatus, S. carnatus, S. caurinus. S. chrysomelas, and S. rastrelliger) makes obtaining sufficient numbers of samples more difficult. Although this study will focus on California blue rockfish populations, its results and the general approach will be applicable to fishes with similar life histories. The proposed index will also provide a means of comparison for fisheries managers to evaluate sub stock structure and interactions.

3) Seasonal Reproductive Timing of Nearshore Fish Species Simply setting size limits does not insure that reproductively capable and/ or active females are protected sufficiently. For example, there is some disagreement in the literature on the size and age at maturity of the leopard shark, Triakis semifasciata ( Smith and Abramson 1990, Cailliet 1992, Kusher et al. 1992, Au and Smith 1997, and Smith et al. 1998). Thus, the California size limit may not protect female leopard sharks so that they can successfully reproduce before entering the fishery. Likewise, without seasonal closure for some species of nearshore rockfishes during their spawning season ( Echeverria 1987), it is possible that fishing pressure could deleteriously affect reproductively capable females, unless there were closed seasons during that period of time.

In response to this need, we will study the reproductive cycle and stage of maturity of the leopard shark by monitoring steroid concentrations in their blood. The purpose of this study will be to examine the serum steroid hormones in female leopard sharks. Previous studies have correlated 17ß estradiol, progesterone, testosterone, and dihydrotestosterone with reproductive events ( Rasmussen and Gruber 1993, Rasmussen and Gruber 1990, Heupel et al. 1999, Koob and Callard 1999, Rasmussen et al. 1999). Blood samples will be taken seasonally in several estuaries along the central California coastline and analyzed using radioimmunoassays. Monitoring of reproductive hormones can provide information regarding reproductive mode, gestation, frequency of pregnancy and location of breeding areas. These details are critical in formulating effective management of these fisheries ( Pratt and Otake 1990). Future extension of this kind of research will prove useful to many other groups of nearshore fishes, especially the viviparous rockfishes, for which seasonal closure might be an effective management tool. FINAL REPORT 31 AUGUST 2000 8 LITERATURE CITED Au, D. W. and S. E. Smith. 1997. A demographic method with population density compensation for estimating productivity and yield per recruit of the leopard shark ( Triakis semifasciata). Canadian Journal of Fisheries and Aquatic Sciences 54: 415 420.

Cailliet, G. M. 1992. Demography of the central California population of leopard shark ( Triakis semifasciata). Australian Journal of Marine and Freshwater Research 43( 1): 183 193.

California Department of Fish and Game ( CDFG). 1998. Live Fishes. In: Review of some California Fisheries for 1997. California Cooperative Oceanic Fisheries Investigations Reports 39: 17 18.

Caswell, H. 1989. Matrix Population Models: Construction, Analysis, and Interpretation. Sinauer Associates, Inc., Sunderland, Massachusetts. 328 p.

Echeverria, T. W. 1987. Thirty four species of California rockfishes: maturity and seasonality of reproduction. Fishery Bulletin 85( 2): 229 250.

Heupel, M. R., J. M. Whittier and M. B. Bennet. 1999. Plasma steroid hormone profiles and reproductive biology of the epaulette shark, Hemiscyllium ocellatum. Journal of Experimental Zoology 284( 5): 586 594.

Karpov, K. A., D. P. Albin, W. H. Van Buskirk. 1995. The marine recreational fishery in northern and central California: A historical comparison ( 1958 86), status of stocks ( 1980 86), and effects of changes in the California Current. California Department of Fish and Game, Fish Bulletin 176, 192 p.

Koob, T. J. and I. P. Callard. 1999. Reproductive endocrinology of female elasmobranchs: lessons from the little skate ( Raja erinacea) and spiny dogfish ( Squalus acanthias). Journal of Experimental Zoology 284( 5): 557 574.

Kusher, D. I., S. E. Smith and G. M. Cailliet. 1992. Validated age and growth of the leopard shark, Triakis semifasciata, from central California. Environmental Biology of Fishes 35( 2): 187 203.

Lacy, R. C. 1987. Loss of genetic diversity from managed populations: Interacting effects of drift, mutation, immigration, selection, and population subdivision. Conservation Biology 1( 2): 143 158.

Lande, R. 1988. Genetics and demography in biological conservation. Science 241: 1455 1460.

Lauth, R. R. 1987. Spawning ecology and nesting behavior of the cabezon, Scorpaenichthys marmoratus ( Ayres), in Puget Sound, Washington. M. S. Thesis, University of Washington. 104 pages.

Lauth, R. R. 1988. Seasonal spawning cycle, spawning frequency, and batch fecundity of the cabezon, Scorpaenichthys marmoratus, in Puget Sound, Washington. Fishery Bulletin 87: 145 154.

Lea, R. N., R. D. McAllister and D. A. VenTresca. 1999. Biological aspects of nearshore rockfishes of the genus Sebastes from central California, with notes on ecologically related sport fishes. California Department of Fish and Game, Fish Bulletin 177, 109 p. FINAL REPORT 31 AUGUST 2000 9 Leet, W. S., C. M. Dewees, and C. W. Haugen ( Editors). 1992. California's living marine resources and their utilization. California Sea Grant Extension Program, Department of Wildlife and Fisheries Biology, University of California, Davis, California Sea Grant Extension Publication UCSGEP 92 12. 257 p.

Love, M. S. and K. Johnson. 1998. Aspects of the life histories of grass rockfish, Sebastes rastrelliger, and brown rockfish, S. auriculatus, from southern California. Fishery Bulletin 87: 100 109.

McKee Lewis, K. K. 1996. Rapid changes and growth of California's live finfish fishery. In: Proceedings from Marketing and Shipping Live Aquatic Products ` 96, Northeast Regional Agricultural Engineering Service ( NRAES 107), p. 116 120.

Nunney, L. 1992. Estimating the effective population size and its importance in conservation strategies. Transactions of the Western Section of the Wildlife Society 28: 67 72.

O'Connell, C. P. 1953. The life history of the cabezon Scorpaenichthys marmoratus ( Ayres). California Department of Fish and Game, Fish Bulletin No. 93, 76 p.

Pratt, H. L. and T. Otake. 1990. Recommendations for work needed to increase our knowledge of reproduction relative to fishery management. In: H. L. Pratt, S. H. Gruber, and T. Taniuchi ( Editors), Elasmobranchs as Living Resources: Advances in the Biology, Ecology, Systematics, and the Status of the Fisheries, p 509 511. United States Department of Commerce.

Rasmussen, L. E. L. and S. H. Gruber. 1990. Serum levels of circulating steroid hormones in freeranging carcharhinoid sharks. In: H. L. Pratt, Jr., S. H. Gruber, and T. Taniuchi ( Editors). Elasmobranchs as Living Resources, NOAA Technical Report NMFS 90, p. 143 155.

Rasmussen, L. E. L. and S. H. Gruber. 1993. Serum concentrations of reproductively related circulating steroid hormones in the free ranging lemon shark, Negaprion brevirostris. Environmental Biology of Fishes 38: 167 174.

Rasmussen, L. E. L., D. L. Hess, and C. A. Luer. 1999. Alterations in serum concentrations in the clearnose skate, Raja eglanteria: Correlations with season and reproductive status. Journal of Experimental Zoology 284( 5): 575 585.

Smith, S. E. and N. J. Abramson. 1990. Leopard shark Triakis semifasciata distribution, mortality rate, yield, and stock replenishment estimates based on a tagging study in San Francisco Bay. Fishery Bulletin 88: 371 381.

Smith, S. E., D. W. Au, and C. Show. 1998. Intrinsic rebound potentials of 26 species of Pacific sharks. Marine and Freshwater Research 49( 7): 663 678.

Soltis, P. A. and M. A. Gitzendanner. 1999. Molecular systematics and the conservation of rare species. Conservation Biology 13( 3): 471 483.

Starr, R. M., K. A. Johnson, E. A. Laman, and G. M. Cailliet. 1998. Fishery resources of the Monterey Bay National Marine Sanctuary. California Sea Grant College System, University of California, La Jolla. 102 p.


[Federal Register: August 3, 2007 (Volume 72, Number 149)]
[Notices]
[Page 43268-43270]
[DOCID:fr03au07-67]

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DEPARTMENT OF ENERGY

Federal Energy Regulatory Commission

 Project No. 2850-013; Hampshire Paper Company; Notice of Intent
To File License Application, Filing of Pre-Application Document,
Commencement of Licensing Proceeding, Scoping Meetings, Solicitation of
Comments on the Pad and Scoping Document, and Identification Issues and
Associated Study Requests

July 30, 2007.
    a. Type of Filing: Notice of Intent to File License Application for
a New License and Commencing Licensing Proceeding.
    b. Project No.: 2850-013.
    c. Date Filed: May 31, 2007.

    d. Submitted by: Hampshire Paper Company.
    e. Name of Project: Emeryville Hydroelectric Project.
    f. Location: On the Oswegatchie River in the hamlet of Emeryville,
in St. Lawrence County, New York. No federal lands are involved.
    g. Filed Pursuant to: 18 CFR Part 5 of the Commission's
Regulations.
    h. Potential Applicant Contact: Michael R. McDonald, Emeryville
Hydroelectric Project, P.O. Box 339, Gouverneur, NY 13642, (315) 287-
1990.
    i. FERC Contact: Patrick Murphy<EMAIL_ADDRESS>(202)
502-8755.
    j. We are asking federal, state, local, and tribal agencies with
jurisdiction and/or special expertise with respect to environmental
issues to cooperate with us in the preparation of the environmental
document. Agencies who would like to request cooperating status should
follow the instructions for filing comments described in paragraph o
below. Cooperating agencies should note the Commission's policy that
agencies that cooperate in the preparation of the environmental
document cannot also intervene. See, 94 FERC ] 61,076 (2001).
    k. With this notice, we are initiating informal consultation with:
(a) The U.S. Fish and Wildlife Service and/or NOAA Fisheries under
section 7 of the Endangered Species Act and the joint agency
regulations thereunder at 50 CFR, Part 402; and (b) the State Historic
Preservation Officer, as required by section 106, National Historical
Preservation Act, and the implementing regulations of the Advisory
Council on Historic Preservation at 36 CFR 800.2.
    l. With this notice, we are designating Hampshire Paper Company as
the Commission's non-federal representative for carrying out informal
consultation, pursuant to section 7 of the Endangered Species Act and
section 106 of the National Historic Preservation Act.
    m. Hampshire Paper Company filed a Pre-Application Document (PAD;
including a proposed process plan and schedule) with the Commission,
pursuant to 18 CFR 5.6 of the Commission's regulations. The Commission
issued its Scoping Document on July 30, 2007.
    n. A copy of the PAD and the scoping document are available for
review at the Commission in the Public Reference Room or may be viewed
on the Commission's Web site (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, of for TTY,<PHONE_NUMBER>. A copy is
also available for inspection and reproduction at the address in
paragraph h.
    Register online at http://ferc.gov/esubscribenow.htm to be notified

via e-mail of new filing and issuances related to this or other pending
projects. For assistance, contact FERC Online Support.
    o. With this notice, we are soliciting comments on the PAD and the
scoping document, as well as study requests. All comments on the PAD
and the scoping document, and study requests should be sent to the
address above in paragraph h. In addition, all comments on the PAD and
the scoping document, study requests, requests for cooperating agency
status, and all communications to and from Commission staff related to
the merits of the potential application (original and eight copies)
must be filed with the Commission at the following address: Kimberly D.
Bose, Secretary, Federal Energy Regulatory Commission, 888 First
Street, NE., Washington, DC 20426. All filings with the Commission must
include on the first page, Emeryville Hydroelectric Project) and number
(P-2850-013), and bear the heading ``Comments on Pre-Application
Document,'' ``Study Requests,'' ``Comments on Scoping Document 1,''
``Request for Cooperating Agency Status,'' or ``Communications to and
from Commission Staff.'' Any individual or entity interested in
submitting study requests, commenting on the PAD or the scoping
document, and any agency requesting cooperating status must do so by
September 28, 2007.
    Comments on the PAD and the scoping document, study requests,
requests for cooperating agency status, and other permissible forms of
communications with the Commission 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.
    p. Although our current intent is to prepare an environmental
assessment (EA), there is the possibility that an Environmental Impact
Statement (EIS) will be required. Nevertheless, this meeting will
satisfy the National Environmental Policy Act scoping requirements,
irrespective of whether an EA or EIS is issued by the Commission.

Scoping Meetings

    Commission staff will hold two scoping meetings in the vicinity of
the project at the time and place noted below. The daytime meeting will
focus on resource agency, Indian tribes, and non-governmental
organization concerns, while the evening meeting is primarily for
receiving input from the public. We invite all interested individuals,
organizations, and agencies to attend one or both of the meetings, and
to assist staff in identifying particular study needs, as well as the
scope of environmental issues to be addressed in the environmental
document. The times and locations of these meetings are as follows:

Evening Scoping Meeting

Date: Tuesday, August 28, 2007.
Time: 6 p.m. (EST).
Location: Gouverneur Library, 60 Church Street, Gouverneur, New York
13642,<PHONE_NUMBER>.

Daytime Scoping Meeting

Date: Wednesday, August 29, 2007.
Time: 1 p.m. (EST).
Location: Gouverneur Library, 60 Church Street, Gouverneur, New York
13642,<PHONE_NUMBER>.

    The scoping document, which outlines the subject areas to be
addressed in the environmental document, was mailed to the individuals
and entities on the Commission's mailing list. Copies of the scoping
document will be available at the scoping meetings, or may be viewed on
the Web at http://www.ferc.gov, using the ``eLibrary'' link. Follow the

directions for accessing information in paragraph n. Depending on the
extent of comments received, Scoping Document 2 may or may not be
issued.

Site Visit

    Hampshire Paper Company will conduct a site visit of the project at
3 p.m. on Tuesday, August 28, 2007. All participants should meet at the
Emeryville Project dam on Route 58N, in Emeryville, New York. Those
wishing to participate should meet at the Emeryville Project dam on
Route 58N, in Emeryville, New York. All participants are responsible
for their own transportation. Anyone with questions about the site
visit should contact Mr. Michael R. McDonald, Emeryville Hydroelectric
Project, P.O. Box 339, Gouverneur, NY 13642,<PHONE_NUMBER>.

Scoping Meeting Objectives

    At the scoping meetings, staff will: (1) Initiate scoping of the
issues; (2) review

and discuss existing conditions and resource management objectives; (3)
review and discuss existing information and identify preliminary
information and study needs; (4) review and discuss the process plan
and schedule for pre-filing activity that incorporates the time frames
provided for in Part 5 of the Commission's regulations and, to the
extent possible, maximizes coordination of federal, state, and tribal
permitting and certification processes; and (5) discuss the
appropriateness of any federal or state agency or Indian tribe acting
as a cooperating agency for development of an environmental document.
    Meeting participants should come prepared to discuss their issues
and/or concerns. Please review the PAD in preparation for the scoping
meetings. Directions on how to obtain a copy of the PAD and the scoping
document are included in item n of this document.

Meeting Procedures

    The meetings will be recorded by a stenographer and will become
part of the formal record of the Commission proceeding on the project.

Kimberly D. Bose,
Secretary.
[FR Doc. E7-15089 Filed 8-2-07; 8:45 am]

BILLING CODE 6717-01-P


[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14457-14459]
[FR Doc No: 2021-05370]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2021-N-0127]

Potential Medication Error Risks With Investigational Drug
Container Labels; Public Meeting; Request for Comments

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of public meeting; request for comments.

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SUMMARY: The Food and Drug Administration (FDA, the Agency, or we) is
announcing the following public meeting entitled ``Potential Medication
Error Risks with Investigational Drug Container Labels.'' This public
meeting is being convened and supported by a partnership between the
Reagan-Udall Foundation and FDA. The purpose of the public meeting is
to solicit input from stakeholders (e.g., sponsors, clinical sites,
entities that supply or otherwise label investigational drugs) on the
risk of medication errors potentially related to the content and format
of information on investigational drug container labels, the prevalence
and nature of such errors, and to gather information on practices that
minimize the potential for medication errors.

DATES: The public meeting will be held virtually and broadcast via
webcast on May 18, 2021, from 1 p.m. to 4 p.m. (Eastern Time), and May
19, 2021, from 10 a.m. to 1 p.m. (Eastern Time). Submit either
electronic or written comments on this public meeting by June 18, 2021.
See the SUPPLEMENTARY INFORMATION section for registration date and
information.

ADDRESSES: Please note that due to the impact of the COVID-19 pandemic,
all meeting participants will be joining this public meeting via an
online teleconferencing platform.
    You may submit comments as follows. Please note that late, untimely
filed comments will not be considered. Electronic comments must be
submitted on or before June 18, 2021. The https://www.regulations.gov
electronic filing system will accept comments until 11:59 p.m. Eastern
Time at the end of June 18, 2021. Comments received by mail/hand
delivery/courier (for written/paper submissions) will be considered
timely if they are postmarked or the delivery service acceptance
receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket No.
FDA-2021-N-0127 for ``Potential Medication Error Risks With
Investigational Drug Container Labels.'' Received comments, those filed
in a timely manner (see ADDRESSES), will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at https://www.regulations.gov or at the Dockets Management
Staff between 9 a.m. and 4 p.m., Monday through Friday,<PHONE_NUMBER>.
     Confidential Submissions--To submit a comment with
confidential information that you do not wish to be made publicly
available, submit your comments only as a written/paper submission. You
should submit two copies total. One copy will include the information
you claim to be confidential with a heading or cover note that states
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will
review this copy, including the claimed confidential information, in
its consideration of comments. The second copy, which will have the
claimed confidential information redacted/blacked out, will be
available for public viewing and posted on https://www.regulations.gov.
Submit both copies to the Dockets Management Staff. If you do not wish
your name and contact information to be made publicly available, you
can provide this information on the cover sheet and not in the body of
your comments and you must identify this information as
``confidential.'' Any information marked as ``confidential'' will not
be disclosed except in accordance with 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in
the heading of this document, into the ``Search'' box and follow the
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852,<PHONE_NUMBER>.

FOR FURTHER INFORMATION CONTACT: Jo Wyeth, Center for Drug Evaluation
and Research, Food and Drug Administration, 10903 New Hampshire Ave.,
Bldg. 22, Rm. 4326, Silver Spring, MD 20993,<PHONE_NUMBER>,
<EMAIL_ADDRESS>or Stephen Ripley, Center for Biologics
Evaluation and Research, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993, 240-402-
7911.

SUPPLEMENTARY INFORMATION:

I. Background

    The purpose of the public meeting announced in this notice is to
solicit input from stakeholders (e.g., sponsors, investigators,
clinical sites, contract research organizations and other entities that
supply or otherwise label investigational drugs, regulators,
professional organizations, and study participants) on the risk of
medication errors potentially related to the content and format of the
information on investigational drug container labels, the prevalence
and nature of such errors, and to gather information on practices that
minimize the potential for medication errors.
    For the purpose of this meeting, an investigational drug means a
drug or

biological product that is used in a clinical investigation under an
investigational new drug application. FDA definitions and requirements
related to investigational new drug applications are provided in 21 CFR
part 312. The requirements for labeling an investigational new drug
include: (1) The immediate package of an investigational new drug
intended for human use shall bear a label with the statement ``Caution:
New Drug--Limited by Federal (or United States) law to investigational
use'' and (2) the label or labeling of an investigational new drug
shall not bear any statement that is false or misleading in any
particular and shall not represent that the investigational new drug is
safe or effective for the purposes for which it is being investigated
(21 CFR 312.6). While not a regulatory requirement, some
investigational new drug container labels may include additional
information such as the protocol/clinical trial number, concentration
and/or strength, dosage form (e.g., tablets, injection), quantity per
container, storage requirements, and lot number. Sponsors of an
investigational new drug application are required to report to FDA any
suspected adverse reaction that is both serious and unexpected (21 CFR
312.32(c)(1)(i)) \1\. Adverse reactions that are not serious or
unexpected or medication errors that do not result in adverse reactions
may be reported in the annual report, or not reported at all. FDA is
aware that globally, other regulatory agencies have varying
requirements related to investigational drug labeling and safety
reporting (Refs. 1 to 3).
---------------------------------------------------------------------------

    \1\ Sponsors have additional investigational new drug safety
reporting requirements that may apply (see 21 CFR 312.32(c)(1)(ii)
through (iv)).
---------------------------------------------------------------------------

    The incidence and scope (e.g., error type; stage in the medication
use system where the error occurred; actual, or potential for, adverse
events; reporting practices) of medication errors associated with
investigational drugs is unknown. FDA recognizes that clinical research
is conducted globally (Ref. 4). Published literature from outside the
United States has pointed to the container labels as a contributing
factor for potential medication errors with investigational drugs and
recommended global harmonization of the information on the labels
(Refs. 5 and 6). For example, a Canadian study that included labels
from blinded protocols provided by European and American sponsors found
almost half of the labels affixed to investigational drug containers
were missing important information (usually the expiration date,
sponsor address, or storage conditions) (Ref. 5). The study also found
other factors that may contribute to medication errors, including the
use of small font sizes (less than 8 point), variable formats for
expiration dates and lot numbers, the presence of error-prone
abbreviations, limited use of color or other differentiation
techniques, and highly similar product or protocol identification
numbers (Ref. 5). A French simulation study using investigational drug
container labels found an error rate of approximately 12 percent (most
errors were related to dosage unit, trial code, drug confusion, or
expiration date) (Ref. 6).
    Best practice guidelines, such as those released by the American
Society of Health System Pharmacists, have recommended specific content
and format for investigational drug container labels (Ref. 7). In 2018,
the Institute for Safe Medication Practices (ISMP) published two
reports on medication error risks with investigational drugs (Refs. 8
and 9). The first report (published in April 2018) explored reported
risks with investigational drug nomenclature, labeling, and packaging,
which included unlabeled containers and look-alike product identifiers,
confusing or missing information (e.g., container labels missing, route
of administration, dosage form, or net quantity) to support safe use,
small unreadable text, and the use of codes and error-prone
abbreviations on container labels (Ref. 9). The second report
(published in May 2018) recommended error mitigation strategies for
clinical sites, sponsors, and other entities that supply
investigational drugs and included the recommendation to standardize
the content and format of information on investigational drug container
labels (Ref. 8).
    FDA reviewed additional reports of medication error concerns
related to unlabeled or poorly labeled investigational drug container
labels (Refs. 10 to 13). The design of container labels can impact the
ability of healthcare providers to readily locate and understand
critical information for product use (Ref. 14), which in turn may
threaten the integrity of clinical investigations and impact the safety
and protection of subjects who participate in these investigations.

II. Topics for Discussion at the Public Meeting

    During the public meeting, speakers and participants will cover a
range of issues related to medication errors and investigational drugs.
Discussion topics related to the format and content of information on
investigational drug container labels include: (1) The prevalence and
types of medication errors attributed to container labels; (2) the
impact of such errors on clinical investigations; (3) information that
should always be on the container label, and how that information
should be presented to facilitate safe use; (4) entities responsible
for labeling containers; (5) existing processes for reporting and
analyzing medication errors and complaints related to container labels;
and (6) global regulatory convergence and differences for the
information on container labels.

III. Participating in the Public Meeting

    Registration: To register for the public meeting, complete the
registration form at https://reaganudall.org/news-and-events/events/investigational-drug-labels. Please provide complete contact
information for each attendee, including name, title, affiliation,
address, email, and telephone number. Registration is free.
    If you need special accommodations due to a disability, please
contact Jo Wyeth (see FOR FURTHER INFORMATION CONTACT) no later than
May 5, 2021.
    Requests for Oral Presentations: During online registration you may
indicate if you wish to present during a public comment session or
participate in a specific session, and which topic(s) you wish to
address. We will do our best to accommodate requests to make public
comments and requests to participate in the focused sessions.
Individuals and organizations with common interests are urged to
consolidate or coordinate their presentations, and request time for a
joint presentation, or submit requests for designated representatives
to participate in the focused sessions. All requests to make oral
presentations must be received by April 28, 2021. We will determine the
amount of time allotted to each presenter and the approximate time each
oral presentation is to begin, and will select and notify participants
by May 3, 2021. If selected for presentation, any presentation
materials must be emailed to Jo Wyeth (see FOR FURTHER INFORMATION
CONTACT) no later than May 10, 2021. No commercial or promotional
material will be permitted to be presented or distributed at the public
meeting.
    Streaming Webcast of the Public Meeting: This public meeting will
be webcast. Persons interested in participating in the webcast are
encouraged to register in advance (see Registration). The webcast will
also be available on the day of the event without preregistration.
Detailed

information for participating in the webcast is available at the
following website: https://reaganudall.org/news-and-events/events/investigational-drug-labels.
    Registered participants will be sent technical system requirements
in advance of the event. It is recommended that you review these
technical system requirements before joining the streaming web
conference of the public meeting.
    FDA has verified the website addresses in this document, as of the
date this document publishes in the Federal Register, but websites are
subject to change over time.
    Transcripts: Please be advised that as soon as a transcript of the
public meeting is available, it will be accessible at https://www.regulations.gov. It may be viewed at the Dockets Management Staff
(see ADDRESSES). A link to the transcript will also be available on the
internet at https://reaganudall.org/news-and-events/events/investigational-drug-labels.

IV. References

    The following references marked with an asterisk (*) are on display
at the Dockets Management Staff (see ADDRESSES) and are available for
viewing by interested persons between 9 a.m. and 4 p.m., Monday through
Friday; they also are available electronically at https://www.regulations.gov. References without asterisks are not on public
display at https://www.regulations.gov because they have copyright
restriction. Some may be available at the website address, if listed.
References without asterisks are available for viewing only at the
Dockets Management Staff. FDA has verified the website addresses, as of
the date this document publishes in the Federal Register, but websites
are subject to change over time.

* 1. European Commission, ``EU Guidelines to Good Manufacturing
Practice; Medicinal Products for Human and Veterinary Use,'' Public
release date: February 3, 2010 (available at https://ec.europa.eu/health/sites/health/files/files/eudralex/vol-4/2009_06_annex13.pdf).
2. Smith-Gick, J., N. Barnes, R. Barone, et al., ``The Near-Term
Viability and Benefits of eLabels for Patients, Clinical Sites, and
Sponsors,'' Therapeutic Innovation and Regulatory Science, vol.
52(5), pp. 537-545, 2018.
* 3. Health Canada, Good Clinical Practices Guidance Document,
``Annex 13 to the Current Edition of the Good Manufacturing
Practices Guidelines Drugs Used in Clinical Trials,'' August 7, 2009
(available at https://www.canada.ca/en/health-canada/services/drugs-health-products/compliance-enforcement/good-clinical-practices/guidance-documents/annex-13-good-manufacturing-practices-guidelines-drugs-clinical-trials-0036.html#a8_7).
* 4. FDA, Guidance for Industry and FDA staff, ``FDA Acceptance of
Foreign Clinical Studies Not Conducted Under an IND; Frequently
Asked Questions,'' March 2012 (available at https://www.fda.gov/media/83209/download). For the most recent version of a guidance,
check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.
5. Duhamel, A., M. Thibault, D. Lebel, et al., ``Investigational
Drug Labeling Variability,'' Clinical Trials, vol. 16(2), pp. 204-
213, 2019.
6. Dollinger, C., V. Schwiertz, L. Sarfati, et al., ``SIMulation of
Medication Error Induced by Clinical Trial Drug Labeling: The SIMME-
CT Study,'' International Journal for Quality in Health Care, vol.
28(3), pp. 311-315, 2016.
7. Kay, S.C., D.G. Luke, and H.R. Tamer, ``ASHP Guidelines for the
Management of Investigational Drug Products,'' American Journal of
Health-System Pharmacy, vol. 75(8), pp. 561-573, 2018.
* 8. ISMP, ``Investigational Drugs: Strategies for Sponsors, FDA,
and Clinical Sites to Prevent Product-Related Errors (Part II),''
Public release date: May 3, 2018 (available at https://www.ismp.org/resources/investigational-drugs-strategies-sponsors-fda-and-clinical-sites-prevent-product-related).
* 9. ISMP, ``Investigational Drugs: Product-Related Issues Pose
Significant Challenges (Part I),'' Public release date: April 19,
2018 (available at https://www.ismp.org/resources/investigational-drugs-product-related-issues-pose-significant-challenges-part-i).
10. Cruz, J.L. and J.N. Brown, ``Safety Risks With Investigational
Drugs: Pharmacy Practices and Perceptions in the Veterans Affairs
Health System,'' Therapeutic Advances in Drug Safety, vol. 6(3), pp.
103-109, 2015.
11. Grissinger, M., ``Reducing the Potential for Mistakes With
Investigational Drugs,'' Pharmacy and Therapeutics, vol. 36(3), pp.
120-138, 2011.
12. Brown, J.N., S.R. Britnell, A.P. Stivers, et al., ``Medication
Safety in Clinical Trials: Role of the Pharmacist in Optimizing
Practice, Collaboration, and Education To Reduce Errors,'' Yale
Journal of Biology and Medicine, vol. 90(1), pp. 125-133, 2017.
* 13. ISMP, ``Remdesivir Investigational Drug Labeling Confusion,''
Acute Care, vol. 25(9), 2020.
* 14. FDA, Draft Guidance for Industry, ``Safety Considerations for
Container Labels and Carton Labeling Design to Minimize Medication
Errors,'' April 2013 (available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safety-considerations-container-labels-and-carton-labeling-design-minimize-medication-errors). When final, this guidance will represent the FDA's current
thinking on this topic. For the most recent version of a guidance,
check the FDA guidance web page at https://www.fda.gov/regulatory-information/search-fda-guidance-documents.

    Dated: March 11, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05370 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P


[Federal Register: August 24, 2010 (Volume 75, Number 163)]
[Rules and Regulations]
[Page 51949-51950]
[DOCID:fr24au10-16]

=======================================================================
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ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 52

[EPA-R04-OAR-2009-0043-201024; FRL-9192-6]

Approval and Promulgation of Air Quality Implementation Plans;
North Carolina and South Carolina; Charlotte-Gastonia-Rock Hill, North
Carolina-South Carolina; Notice of Completeness Determination for the
Purpose of Stopping Sanctions Clock

AGENCY: Environmental Protection Agency (EPA).

ACTION: Notice of Letter to Governor Regarding Completeness and
Stopping of Sanctions Clock.

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SUMMARY: EPA is now giving notice of an action that EPA has already
taken to find two State Implementation Plan (SIP) revisions complete
and stop sanctions clocks associated with the Charlotte-Gastonia-Rock
Hill North Carolina, South Carolina 1997 8-hour ozone nonattainment
area (hereafter referred to as the ``bi-state Charlotte Area'').
Pursuant to the Clean Air Act (CAA) and its implementing regulations,
EPA has made an affirmative determination of completeness for the
attainment demonstrations submitted by the States of North Carolina and
South Carolina the bi-state Charlotte Area. On May 27, 2010, letters
announcing this determination were sent to the Governors of North
Carolina and South Carolina, effectively stopping the sanctions clock
started on May 8, 2009, by a finding of failure to submit the
attainment demonstrations. This notice is simply an announcement of a
determination that EPA has already made.

ADDRESSES: EPA has established a docket for this action under Docket
Identification No. EPA-R04-OAR-2009-0043. All documents in the docket
are listed on the http://www.regulations.gov Web site. Although listed
in the index, some information is not publicly available, i.e.,
Confidential Business Information or other information whose disclosure
is restricted by statute. Certain other material, such as copyrighted
material, is not placed on the Internet and will be publicly available
only in hard copy form. Publicly available docket materials are
available either electronically through http://www.regulations.gov or
in hard copy at the Regulatory Development Section, Air Planning
Branch, Air, Pesticides and Toxics Management Division, U.S.
Environmental Protection Agency, Region 4, 61 Forsyth Street, SW.,
Atlanta, Georgia 30303-8960. EPA requests that if at all possible, you
contact the person listed in the FOR FURTHER INFORMATION CONTACT
section to schedule your inspection. The Regional Office's official
hours of business are Monday through Friday, 8:30 to 4:30, excluding
Federal holidays.

FOR FURTHER INFORMATION CONTACT: Nacosta C. Ward, Regulatory
Development Section, Air Planning Branch, Air, Pesticides and Toxics
Management Division, U.S. Environmental Protection Agency, Region 4, 61
Forsyth Street, SW., Atlanta, Georgia 30303-8960. The telephone number
is<PHONE_NUMBER>. Ms. Ward can also be reached via electronic mail at
<EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION: Effective June 15, 2004, the bi-state
Charlotte Area was designated nonattainment for the 8-hour ozone
national ambient air quality standards (NAAQS) with a moderate
classification. The bi-state Charlotte Area is comprised of Cabarrus,
Gaston, Lincoln, Mecklenburg, Rowan, Union and a portion of Iredell
(Davidson and Coddle Creek Townships) Counties in North Carolina; and a
portion of York County, South Carolina. For the 1997 8-hour ozone
NAAQS, States were required to submit an attainment demonstration,
reasonable further progress plan, and reasonable available control
technology submittals (for areas classified as moderate or above) by
June 15, 2007. EPA received the required submittals from North Carolina
on June 15, 2007, and South Carolina on August 31, 2007.
    On December 19, 2008, and December 22, 2008, the States of North
Carolina and South Carolina, respectively, submitted letters to EPA
withdrawing their attainment demonstrations for the bi-state Charlotte
Area. On May 8, 2009, EPA published a finding of failure to submit
final rulemaking for North Carolina and South Carolina for these
required SIPs. 74 FR 21550.
    On November 12, 2009, and April 5, 2010, North Carolina submitted
all components of the North Carolina attainment demonstration SIP for
North Carolina's portion of the bi-state Charlotte Area. On November
13, 2009, and April 29, 2010, South Carolina submitted all components
of the attainment demonstration SIP for South Carolina's portion of the
bi-state Charlotte Area. EPA has done a completeness review, in
accordance with Section 2.0 ``Criteria'' of Appendix V of 40 CFR Part
51--Criteria for Determining the Completeness of Plan Submissions, to
ensure that the States have submitted all of the required information
for the SIP submissions.
    As explained in the letters sent by EPA to the Governors of North
and South Carolina, on May 27, 2010,\1\ EPA has determined that the
States have corrected the deficiency identified in EPA's promulgated
finding of failure to submit the required attainment demonstration SIPs
for the bi-state Charlotte Area. Specifically, EPA has determined that
both North Carolina and South Carolina have submitted complete SIP
submittals for the bi-state Charlotte Area to meet the CAA requirement
for attainment demonstrations for moderate nonattainment areas under
the 1997 8-hour ozone NAAQS. EPA will make a determination on the
approvability of these attainment demonstration SIPs for the bi-state
Charlotte Area in a separate action. This announcement only relates to
a completeness determination for the attainment demonstration SIPs for
the bi-state Charlotte Area, and is separate from EPA's determination
of approvability of these attainment demonstrations. This action is
simply a notice of a determination that EPA already made through
correspondence

with the Governors of North and South Carolina.
---------------------------------------------------------------------------

    \1\ In the May 27, 2010, letters, EPA inadvertently identified
incorrect submittal dates for North Carolina and South Carolina's
SIP submissions. On June 18, 2010, EPA sent letters to North
Carolina and South Carolina to correct the dates of the SIP
submissions.

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    Authority: 42 U.S.C. 7401 et seq.

    Dated: August 11, 2010.
A. Stanley Meiburg,
Acting Regional Administrator, Region 4.
[FR Doc. 2010-20989 Filed 8-23-10; 8:45 am]
BILLING CODE 6560-50-P


[Federal Register: July 1, 2008 (Volume 73, Number 127)]
[Notices]
[Page 37520-37521]
[DOCID:fr01jy08-83]

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SECURITIES AND EXCHANGE COMMISSION

[Release No. 34-58014; File No. SR-NASDAQ-2008-055]

Self-Regulatory Organizations; The NASDAQ Stock Market LLC;
Notice of Filing of Proposed Rule Change Regarding Fees for Orders
Routed via the Options Intermarket Linkage

June 24, 2008.
    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 June 18, 2008, The NASDAQ Stock Market LLC (``Nasdaq'' or
``Exchange'') filed with the Securities and Exchange Commission
(``Commission'') the proposed rule change as described in Items I, II,
and III below, which Items have been substantially prepared by Nasdaq.
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.
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I. Self-Regulatory Organization's Statement of the Terms of Substance
of the Proposed Rule Change

    Nasdaq proposes to amend its fees related to orders routed to the
NASDAQ Options Market (``NOM'') via the Options Intermarket Linkage
(``Linkage'') \3\ to establish a Linkage Fee Pilot Program that is
effective through July 31, 2009 and to clarify the application of
options transaction fees for trades executed through Linkage on the
Exchange. Nasdaq will implement the proposed rule upon approval. The
text of the proposed rule change is available at Nasdaq, the
Commission's Public Reference Room, and http://www.nasdaq.com.
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    \3\ On July 28, 2000, the Commission approved a national market
system plan for the purpose of creating and operating an intermarket
options market linkage proposed by the American Stock Exchange LLC,
Chicago Board Options Exchange, Inc., and International Securities
Exchange LLC. See Securities Exchange Act Release No. 43086 (July
28, 2000), 65 FR 48023 (August 4, 2000). Subsequently, the
Philadelphia Stock Exchange, Inc., Pacific Exchange, Inc. (n/k/a
NYSE Arca), Boston Stock Exchange, Inc., and Nasdaq joined the
Linkage Plan. See Securities Exchange Act Release Nos. 43573
(November 16, 2000), 65 FR 70851 (November 28, 2000); 43574
(November 16, 2000), 65 FR 70850 (November 28, 2000); 49198
(February 5, 2004), 69 FR 7029 (February 12, 2004); and 57545 (March
21, 2008), 73 FR 16394 (March 27, 2008).
---------------------------------------------------------------------------

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

    In its filing with the Commission, Nasdaq 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. Nasdaq 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 purpose of this proposed rule change is to establish a Linkage
Fee Pilot Program that is effective through July 31, 2009 and to
clarify the application of options transaction fees for trades executed
through the Linkage on the Exchange. Under this pilot, the fees
applicable to Nasdaq members entering orders directly into NOM systems
will apply to Nasdaq members and non-members that enter orders into
other options exchanges that are then routed to Nasdaq via the Linkage
and executed on NOM.
    Under the Exchange's current Rule 7050(1), the fee for members
entering an order that executes on the NOM is $.45 per executed
contract. Nasdaq's current rule does not differentiate between orders
entered directly into the NOM via Nasdaq systems and orders received by
Nasdaq via the Linkage. Since the launch of the NOM, Nasdaq has been
assessing the same fee for all orders executed on behalf of members on
its market regardless of whether such orders were entered directly into
Nasdaq systems or via the Linkage.
    Nasdaq did not differentiate between those groups because firms
that are members of away markets are, by and large, also members of
Nasdaq. Nasdaq states that, all orders received via the Linkage and
executed by Nasdaq have been entered on away markets by firms that are
also Nasdaq members. Nonetheless, the possibility exists that a firm
that is not a Nasdaq member could enter an order that is routed to
Nasdaq via the Linkage and executed by

Nasdaq. In that case, under Nasdaq's current rule, Nasdaq would lack an
approved rule to assess an execution fee to that non-member.
    Nasdaq believes it is proper to charge the same fee for executions
regardless of whether an order was entered directly into Nasdaq's
systems or routed to Nasdaq via the Linkage. Since most firms join
multiple exchanges, pricing that differentiates between orders
originating in different markets tends to skew trading behaviors in
ways that are unintended and possibly detrimental.
2. Statutory Basis
    The proposed rule change is consistent with Section 6(b) of the
Act,\4\ in general, and furthers the objectives of Section 6(b)(4) of
the Act,\5\ 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. The proposed
Linkage Fee Pilot Program will result in the same fee being charged for
the execution of all orders regardless of the manner in which they are
sent to the Exchange.
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    \4\ 15 U.S.C. 78f(b).
    \5\ 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. To the contrary, Nasdaq
notes that the options markets compete aggressively on the basis of
execution price and that the proposal is part of Nasdaq's attempt to
compete effectively.

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

    Written comments were neither solicited nor received.

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

    Within 35 days of the date of publication of this notice in the
Federal Register or within such longer period (i) as the Commission may
designate up to 90 days of such date if it finds such longer period to
be appropriate and publishes its reasons for so finding or (ii) as to
which the self-regulatory organization consents, the Commission will:
    A. By order approve such proposed rule change, or
    B. Institute proceedings to determine whether the proposed rule
change should be disapproved.

IV. Solicitation of Comments

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

Electronic Comments

     Use the Commission's Internet comment form (http://
www.sec.gov/rules/sro.shtml); or
     Send an e-mail to<EMAIL_ADDRESS>Please include
File No. SR-NASDAQ-2008-055 on the subject line.

Paper Comments

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

All submissions should refer to File Number SR-NASDAQ-2008-055. 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, 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-NASDAQ-2008-055 and should be submitted on or before
July 22, 2008.

    For the Commission, by the Division of Trading and Markets,
pursuant to delegated authority.\6\
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    \6\ 17 CFR 200.30-3(a)(12).
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Florence E. Harmon,
Acting Secretary.
[FR Doc. E8-14833 Filed 6-30-08; 8:45 am]

BILLING CODE 8010-01-P