January 4, 2005 – Federal Register Recent Federal Regulation Documents

DEA is amending its regulations to require additional recordkeeping and reporting requirements for drug products containing gamma-hydroxybutyric acid (GHB) for which an application has been approved under the Federal Food, Drug, and Cosmetic Act. DEA makes these changes under section 4 of the ``Hillory J. Farias and Samantha Reid Date-Rape Drug Prohibition Act of 2000.'' These additional requirements are necessary to protect against the diversion of GHB for illicit purposes.

The President's National Security Telecommunications Advisory Committee (NSTAC) will meet via conference call on Wednesday, January 19, 2005, from 4 p.m. until 5 p.m. The conference call will be closed to the public. The NSTAC advises the President of the United States on issues and problems related to implementing national security and emergency preparedness (NS/EP) communications policy.

The FAA proposes to adopt a new airworthiness directive (AD) for all Airbus Model A330-223, -321, -322, and -323 airplanes. This proposed AD would require repetitive inspections of the firewall of the lower aft pylon fairing (LAPF), and corrective actions if necessary. This proposed AD is prompted by reports of cracking of the LAPF firewall. We are proposing this AD to detect and correct this cracking, which could reduce the effectiveness of the firewall and result in an uncontrolled engine fire.

Pursuant to section 102(2)(C) of the National Environmental Policy Act of 1969 (Pub. L. 91-190, as amended), and the Council on Environmental Quality Regulations (40 CFR part 1500-1508), the National Park Service (NPS), Department of the Interior, has prepared a Draft Environmental Impact Statement identifying and evaluating five alternatives for a Non-Native Deer Management Plan for Point Reyes National Seashore administered lands. Potential impacts, and appropriate mitigations, are assessed for each alternative. When approved, the plan will guide, for the next 15 years, non-native deer management actions on lands administered by Point Reyes National Seashore. The Non-Native Deer Management Plan and Draft Environmental Impact Statement documents the analyses of four action alternatives, and a ``no action'' alternative. Five other preliminary alternatives were considered but rejected because they did not achieve the objectives of the non-native deer management plan or were infeasible. Planning Background: Axis deer (Axis axis) are native to India and fallow deer (Dama dama) are native to Asia Minor and the Mediterranean region. Axis and fallow deer were introduced to the Point Reyes area in the 1940s and 1950s, before establishment of the Seashore. Between 1976 and 1994, NPS rangers removed more than 2,000 non-native deer. In 1994, cullling was discontinued. Since then, non-native deer have not been actively managed and numbers and range have increased to, or surpassed, pre-control levels. Seashore staff estimates current numbers of axis and fallow deer to be approximately 250 and 860, respectively. The purpose of the Non-Native Deer Management Plan (NNDMP) is to define management prescriptions for non-native deer. Both the park's General Management Plan (GMP) and Resource Management Plan (RMP), identify goals for management of these exotic species. The park's 1999 RMP indicates ``Regardless of potential competition and disease issues, the presence of these non-native deer compromises the ecological integrity of the Seashore and the attempts to reestablish the native cervid fauna comprising tule elk and black-tailed deer'' and notes that three scientific panels comprised of federal, state, and university researchers and managers recommended the removal of non-native deer to promote restoration of native deer and elk. The objectives of the plan are: To correct past and ongoing disturbances to Seashore ecosystems from introduced non-native ungulates and thereby to contribute substantially to the restoration of naturally functioning native ecosystems. To minimize long-term impacts, in terms of reduced staff time and resources, to resource protection programs at the Seashore, incurred by continued monitoring and management of non-native ungulates. To prevent spread of populations of both species of non- native deer beyond Seashore and GGNRA boundaries. To reduce impacts of non-native ungulates through direct consumption of forage, transmission of disease to livestock and damage to fencing to agricultural permittees within pastoral areas. The primary problems associated with the presence of these nonnative deer are their interference with native species and native ecosystems; conflicts with the laws, regulations and NPS policies regarding restoration of natural conditions and native species; and the impacts on ranchers in the park, on park operations, budget. In addition there is the potential for each of these impacts to increase as deer populations expand beyond park boundaries. The objectives of the planning effort are to solve these problems. The planning area for the NNDMP includes NPS lands located approximately 40 miles northwest of San Francisco in Marin County, California. These lands include the 70,046-acre Point Reyes National Seashore, comprised primarily of beaches, coastal headlands, extensive freshwater and estuarine wetlands, marine terraces, and forests; as well as 18,000 acres of the Northern District of Golden Gate National Recreation Area (GGNRA), primarily supporting annual grasslands, coastal scrub, and Douglas-fir and coast redwood forests. Thirty-five percent, or 32,000 acres, of Seashore lands are managed as wilderness. Proposed Non-Native Deer Management Plan: Alternative E is the agency-preferred alternative in the Draft Environmental Impact Statement (EIS). Under this alternative (Removal of All Non-Native Deer by a Combination of Agency Removal and Fertility control -Sterilants or Yearly Contraception), all axis and fallow deer inhabiting the Seashore and the GGNRA lands administered by the Seashore would be eradicated by approximately 2020 through lethal removal and fertility control. Culling would be conducted by NPS staff specifically trained in wildlife sharpshooting. The contraceptive program would incorporate the latest contraceptive technologies to safely prevent reproduction, for as long as possible, and with minimal treatments per animal. Because no long-acting ``sterilant'' has been approved for use in wildlife by the Food and Drug Administration, studies on safe and efficacious use of a candidate drug would have to be conducted at PRNS before it could be used for management and population control. Population models of Seashore fallow deer indicate that under this alternative, if the contraceptives used were effective in blocking fertility for at least 4 years, eradication could be accomplished with fewer fallow deer lethally removed. Because the effectiveness of long-term contraceptives on axis deer is unknown, similar models have not been developed for this species. Studies on sterilant efficacy and deer population response to treatment will be used adaptively to guide the non-native deer management program. The goal will be to maximize benefits to natural resources and minimize safety risks to NPS staff, while striving to reduce numbers of animals killed. Alternatives To Proposed Plan: The NNMP / Draft EIS analyzes four alternatives besides the preferred alternative. Alternatives E and D (Removal of All Non-Native Deer by Agency Removal) are both identified in the Draft EIS as the ``environmentally preferred'' alternatives and are considered equally likely to best protect the biological and physical environment of the project area. Both would result in eradication of non-native deer within 15 years and consequently would result in complete removal of all adverse impacts caused by non-native deer to wildlife, vegetation, soils, special status species and water resources. Alternative ANo Action. This alternative represents the current non-native deer management program. It would perpetuate the non-native deer management practices undertaken since 1994, when ranger culling was discontinued. No actions to control the size of non-native deer populations would be taken. In order to ensure protection of native species and ecosystems, continued monitoring for at least 15 years would be an integral part of this alternative as well as all other alternatives considered. Alternative BControl of Non-Native Deer at Pre-Determined Levels by Agency Removal. Alternative B would focus on the use of lethal control to reduce the size of non-native deer populations. Culling would be conducted by NPS staff specifically trained in wildlife sharpshooting. Non-native deer populations would be maintained at a level of 350 for each species (700 total axis and fallow deer). Because fallow deer concentrations are currently higher than this, and axis deer populations are lower than this target, the focus of initial reductions would be on fallow deer. This target population level was chosen because of its history, and for management reasons. However, the number would be re-evaluated by resource managers regularly and could be changed based on results of ongoing monitoring programs. Efforts would be made to reach target (reduced) levels in 15 years and to ensure continued presence of both species in the Seashore. Because fallow deer currently exceed 350 animals, and axis deer have historically done so, any chosen population control method would need to be used in perpetuity to maintain each species at this population size. Because the management time frame is very long (theoretically lasting forever), the total numbers of deer lethally removed could be very high. Alternative CControl of Non-Native Deer at Pre-Determined Levels by Agency Removal and Fertility Control. As in Alternative B, non- native deer populations would be maintained at a level of 350 for each species (700 total axis and fallow deer), but through a combination of lethal removals and fertility control. This target population level was chosen because of its history, and for management reasons. However, the number would be re-evaluated by resource managers regularly and could be changed based on results of ongoing monitoring programs. Culling would be conducted by NPS staff specifically trained in wildlife sharpshooting. The contraceptive program would incorporate the latest contraceptive technologies to safely prevent reproduction, for as long as possible, and with minimal treatments per animal. Because no long- acting ``sterilant'' has been approved for use in wildlife by the Food and Drug Administration, studies on safe and efficacious use of a candidate drug would have to be conducted at PRNS before it could be used for management and population control. Population models of Seashore fallow deer indicate that under Alternative C, if the contraceptive used were effective in blocking fertility in does for at least 4 years, population control could be accomplished with fewer fallow deer lethally removed. Because the effectiveness of long-term contraceptives on axis deer is unknown, similar models have not been developed for this species. Studies on sterilant efficacy and deer population response to treatment would be used adaptively to guide the non-native deer management program in maximizing benefits to natural resources and in minimizing safety risks to NPS staff, while striving to reduce numbers of animals killed. Because fallow deer numbers are currently higher than 350, and axis deer populations are lower than this target, the focus of initial reductions would be on fallow deer. Efforts would be made to reach target (reduced) levels in 15 years. Because the goal of this alternative will be to control axis and fallow deer at a specified level and not to eradicate them from PRNS, annual culling and fertility control would continue indefinitely. Because the management time frame is very long (theoretically lasting forever), the total numbers of deer removed and treated with contraceptives could also be very high under this alternative. Alternative DRemoval of All Non-Native Deer by Agency Personnel. In Alternative D, all axis and fallow deer inhabiting the Seashore and the GGNRA lands administered by the Seashore would be eradicated through lethal removal (shooting) by 2020. Culling would be conducted by NPS staff specifically trained in wildlife sharpshooting. The management actions included in this alternative would continue until both species were extirpated, with a goal of full removal in no more than 15 years. This time frame minimizes the total number of deer removed (a longer period of removal would mean more fawns are born and more total deer are killed) and is reasonable from a cost and logistics standpoint. Because of their current large numbers (250 axis deer and 860 fallow deer), it is expected that total removal of both species would require a minimum of 13 years. Monitoring during program implementation would be done to assess program success and to guide adjustments in the location, intensity and logistics of removal. Actions Common to All AlternativesIn order to ensure protection of native species and ecosystems and to assess success of any management program, continued monitoring for at least 15 years would be an integral part of any Alternative Chosen. All actions which involve direct management of individual animals, ranging from aerial surveillance to live capture and lethal removal, would be conducted in a manner which minimizes stress, pain and suffering to every extent possible. All actions occurring in designated Wilderness, from monitoring to active deer management, would be consistent with the ``minimum requirement'' concept. Scoping Summary: On April 10, 2002, a ``Notice of Scoping for Non- Native Deer Management Plan at Point Reyes National Seashore'' was published in the Federal Register (v67, n69, pp 17446-17447). Through public scoping and internal analysis by the Seashore's interdisciplinary NNDMP/EIS team, it was determined that an Environmental Impact Statement, rather than an Environmental Assessment, should be prepared. As mandated by NEPA, an EIS was chosen because data was deemed insufficient to decide whether the project had potential to be controversial because of disagreement over possible environmental effects. In addition to consulting NPS resource specialists, within and outside the Seashore, park managers consulted federal, state and local agencies about management issues of concern. The beginning of public scoping was announced on May 4, 2002, at a public meeting of the Point Reyes National Seashore Citizens Advisory Commission with a presentation on the NNDMP planning process. In this meeting, input on non-native deer management issues of concern and range of alternatives was solicited from the public. The public meeting featured a short presentation by the Seashore wildlife biologist on the environmental planning process, background on non-native deer, and issues of importance to park management. Background informational handouts were provided. Members of the Citizen's Advisory Committee for Point Reyes National Seashore and Golden Gates National Recreation Area were given the opportunity to ask questions of park staff. Five individuals spoke at the public meeting. A sign-up sheet at the public meeting provided an opportunity for members of the public to be included on a mailing list for upcoming information on the management plan in development. Public comments were accepted in letter or email form from May 4, 2002 until July 5, 2002. All those who sent written comments during the scoping period and included a return mailing address were also put on the mailing list. An acknowledgment of the Seashore's receipt of written comments, in postcard form, was also sent to those who wrote letters. A similar e-mail message was sent back to those who emailed comments. A total of 32 written comments were received by the close of the public comment period. The major themes communicated by the public during the May 4, 2002 meeting and the subsequent scoping period encompassed a range, from a desire to retain non-native deer in the park or to use non-lethal deer control techniques, to concern about impacts to natural resources from non-native deer and a desire to eliminate all non-native deer from the Seashore. Commenting on the Draft EIS: The purpose of the management plan is to define management prescriptions for non-native deer. A public workshop on the proposed NNDMP will be held during late winter 2005 at the Point Reyes National Seashore Red Barn meeting (confirmed date and other workshop details will be advertised by direct mailing to 210 individuals and organizations) and a notice placed in the local newspapers. All interested individuals, organizations, and agencies will be encouraged to provide comments, suggestions, and relevant information (earlier scoping comments need not be resubmitted); written comments must be postmarked not later than 60 days following publication in the Federal Register by EPA of their notice of filing of the availability of the Draft EIS (as soon as this date can be confirmed it will be announced on the park's website, and included in the workshop mailing). Questions at this time regarding the NNDMP planning process or work shop should be addressed to the Superintendent either by mail (see address below) or by telephone at (415) 663-8522. Please note that names and addresses of people who comment become part of the public record. If individuals commenting request that their name and/or address be withheld from public disclosure, it will be honored to the extent allowable by law. Such requests must be stated prominently in the beginning of the comments. There also may be circumstances wherein the NPS withholds from the record a respondent's identity, as allowable by law. As always: the NPS will make available to public inspection all submissions from organizations or businesses and from persons identifying themselves as representatives or officials of organizations and businesses; and, anonymous comments may not be considered.

Today's action proposes to allow refiners and importers who produce or import conventional gasoline for use in Alaska, Hawaii, the Commonwealth of Puerto Rico and the Virgin Islands to change the way that they calculate emissions from such gasoline for purposes of calculating their conventional gasoline anti-dumping baselines and evaluating annual average emissions. Specifically, for gasoline sold in these areas, refiners and importers could elect to modify their baselines to replace the anti-dumping statutory baseline with the single seasonal statutory baseline that is most appropriate to the regional climate, and to use the seasonal component of the Complex Model that is most appropriate to the regional climate to calculate individual baselines and annual average emissions. This action would allow refiners and importers to petition EPA to use the summer statutory baseline and the summer Complex Model for all anti-dumping baseline and compliance calculations for conventional gasoline produced or imported for use in Hawaii, Puerto Rico and the Virgin Islands and would allow refiners and importers to petition EPA to use the winter statutory baseline and the winter Complex Model for all anti-dumping baseline and compliance calculations for conventional gasoline produced or imported for use in Alaska. We are proposing these actions to address certain inconsistencies in the RFG program's anti-dumping provisions which may have significant unintended negative impacts on refiners and importers who produce or import gasoline for these areas. Today's action would also extend similar seasonal baseline and compliance modifications to the provisions applicable to conventional gasoline under Gasoline Toxics, also known as the Mobile Source Air Toxics rule, or MSAT.

This document contains a technical amendment to the Federal motor vehicle safety standard (FMVSS) No. 119, New pneumatic tires for vehicles other than passenger cars. Specifically, the amendment changes the metric value of tire speed restriction threshold from 88 km/h (55 mph) to 90 km/h (55 mph). The amendment will make FMVSS No. 119 more consistent with established tire industry protocol and labeling technology, without making any substantive changes to the standard.

We are amending the emerald ash borer regulations by adding areas in Indiana, Michigan, and Ohio to the list of areas quarantined because of emerald ash borer. As a result of this action, the interstate movement of regulated articles from those areas is restricted. This action is necessary to prevent the artificial spread of this plant pest from infested areas in the States of Indiana, Michigan, and Ohio into noninfested areas of the United States.

Notice is hereby given that a complaint was filed with the U.S. International Trade Commission on November 24, 2004, under section 337 of the Tariff Act of 1930, as amended, 19 U.S.C. 1337, on behalf of 3M Company, 3M Innovative Properties Company, both of St. Paul, Minnesota, and Jean Silvestre of Hamoir, Belgium. An amended complaint was filed on December 13, 2004. The amended complaint alleges violations of section 337 in the importation into the United States, the sale for importation, and the sale within the United States after importation of certain foam masking tape by reason of infringement of claims 1-4, 7-10, 13, 16-21 and 23-24 of U.S. Patent No. 4,996,092, and claims 1, 3, 4, 6-8, 10-11, 13, 14 and 16 of U.S. Patent No. 5,260,097. The complaint further alleges that an industry in the United States exists as required by subsection (a)(2) of section 337. The complainants request that the Commission institute an investigation and, after the investigation, issue a permanent exclusion order and permanent cease and desist orders.

Notice is hereby given that Region 6 of the U.S. Fish and Wildlife Service (Service) has issued the following recovery permits for endangered species, between May 1, 2004, and December 31, 2004. We also announce our intention to issue recovery permits to conduct certain activities pertaining to scientific research and enhancement of survival of endangered species.

Pursuant to the authorities in the Federal Advisory Committee Act (Pub. L. 92-463) and under the Secure Rural Schools and Community Self-Determination Act of 2000 (Pub. L. 106-393) the Beaverhead- Deerlodge National Forest's Tri-County Resource Advisory Committee will meet on Thursday, February 3, 2005, from 4 p.m. to 8 p.m. in Deer Lodge, Montana, for a business meeting. The meeting is open to the public.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the collection of information from manufacturers of monoenergetic neutron sources in order to comply with an amendment to FDA's food additive regulations.

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the standardized format and content requirements for the labeling of over-the-counter (OTC) drug products.

The Nuclear Regulatory Commission (NRC) is withdrawing a portion of a proposed rule (Subpart I, April 30, 2002; 67 FR 21390) that would have allowed certificate holders for dual-purpose (storage and transport) spent fuel casks, designated as Type B(DP) packages, to make certain design changes to the transportation package without prior NRC approval. The NRC is taking this action because it has received significant comments regarding the cost and complexity to implement the proposed change authority rule.

The FAA is correcting a typographical error in an existing airworthiness directive (AD) that was published in the Federal Register on December 9, 2004 (69 FR 71339). The docket number of the final rule was incorrectly cited as FAA-2004-19767. This AD applies to all EMBRAER Model EMB-135 and -145 series airplanes. This AD requires a one-time inspection of each passenger service unit (PSU) to determine the serial number of the printed circuit board (PCB) installed in each PSU, replacement of the PCB if necessary, related investigative actions, and other specified actions.

The Federal Energy Regulatory Commission is proposing to amend in Docket No. RM96-1-026 its regulations governing standards for conducting business practices with interstate natural gas pipelines. The Commission is proposing to incorporate by reference the most recent version of the standards, Version 1.7, promulgated December 31, 2003, by the Wholesale Gas Quadrant (WGQ) of the North American Energy Standards Board (NAESB); the standards ratified by NAESB on June 25, 2004, to implement Order No. 2004, and the standards implementing gas quality reporting requirements ratified by NAESB on October 20, 2004. These standards can be obtained from NAESB at 1301 Fannin, Suite 2350, Houston, TX 77002, 713-356-0060, https://www.naesb.org. The Commission is also terminating a rulemaking, instituted by a Notice of Proposed Rulemaking in Docket No. RM96-1-015, issued on June 30, 2000, which examined whether the Commission should require pipelines to permit shippers to designate and rank the contracts under which gas flows on their systems.

The Federal Energy Regulatory Commission (Commission) affirms, with certain clarifications, the fundamental determinations in Order No. 2003-A.

The Director, Regulatory Information Management Services, Office of the Chief Information Officer, invites comments on the proposed information collection requests as required by the Paperwork Reduction Act of 1995.

As required by 43 CFR 2650.7(d), notice is hereby given that an appealable decision approving lands for conveyance pursuant to the Alaska Native Claims Settlement Act, will be issued to Unga Corporation, for lands in Tps. 57 and 58 S., R. 74 W., SM; Tps. 56 and 57 S., R. 75 W., SM; Tps. 57 and 58 S., R. 76 W., SM; located in the vicinity of Unga, Alaska, containing 14,565.96 acres. Notice of the decision will also be published four times in the Dutch Harbor Fisherman.

The Department of Education (Department) issues these final regulations to adjust the Department's civil monetary penalties (CMPs) for inflation.

NMFS issues this temporary final rule to implement interim measures recommended by the Caribbean Fishery Management Council (Council). This rule prohibits fishing for or possessing any species of fish, except highly migratory species, within the Grammanik Bank closed area on a temporary basis (see DATES). The intended effect of this rule is to protect a yellowfin grouper spawning aggregation and to reduce overfishing.

We are advising the public that the Animal and Plant Health Inspection Service has prepared an environmental assessment relative to a final rule published in today's issue of the Federal Register to amend the regulations regarding the importation of animals and animal products to recognize, and add Canada to, a category of regions that present a minimal risk of introducing bovine spongiform encephalopathy into the United States via live ruminants and ruminant products. The rule also sets out conditions under which certain live ruminants and ruminant products and byproducts may be imported from such regions. We are making the environmental assessment available to the public for review and comment.