The regulations in 9 CFR part 94 (referred to below as the regulations) govern the importation of certain animals and animal products into the United States in order to prevent the introduction of various animal diseases, including rinderpest and foot-and-mouth disease (FMD). These are dangerous and destructive communicable diseases of ruminants and swine. Section 94.1 of the regulations lists regions of the world that are considered free of rinderpest and FMD. Section 94.11 lists regions of the world considered free of rinderpest and FMD but from which the importation of meat and other animal products into the United States is subject to additional restrictions because of those regions' proximity to or trading relationships with FMD-affected regions.

In an interim rule effective November 6, 2000, and published in the Federal Register on February 9, 2001 (66 FR 9641-9643, Docket No. 00-122-1), we amended the regulations by removing the Republic of South Africa from the list of regions considered to be free of rinderpest and FMD. We also removed the Republic of South Africa from the list of regions in § 94.11 that are considered to be free of these diseases, but are subject to certain restrictions because of their proximity to or trading relationships with rinderpest- or FMD-affected regions. These actions were necessary because FMD had been confirmed in two provinces in the Republic of South Africa. The effect of the interim rule was to prohibit or restrict the importation of ruminants and swine and the fresh meat and other animal products of ruminants and swine into the United States from the Republic of South Africa.

Although we removed the Republic of South Africa from the list of regions considered to be free of rinderpest and FMD, we recognized that the Republic of South Africa's National Department of Agriculture responded immediately to the detection of the disease by imposing restrictions on the movement of ruminants, swine, and ruminant and swine products from the affected areas and by initiating measures to eradicate the disease. We stated that we intended to reassess the situation in the region at a future date in accordance with Office International des Epizooties (OIE) standards. We solicited comments concerning our interim rule ending April 10, 2001; we received no comments by that date.

In this notice, we are announcing the availability for review and comment of a document entitled “Evaluation of the Foot-and-Mouth Disease Status of the Republic of South Africa” (October 2007). This risk analysis assesses the FMD status of the Republic of South Africa and the related disease risks associated with importing animals and animal products into the United States from the Republic of South Africa. This risk analysis will be considered as part of our decisionmaking process regarding whether to relieve certain prohibitions and restrictions on the importation of ruminants and swine and the fresh meat and other animal products of ruminants and swine into the United States from the Republic of South Africa. The importation of live swine and certain swine products would continue to be restricted because the Republic of South Africa has not been evaluated by APHIS for African swine fever, classical swine fever, and swine vesicular disease. We are making the risk analysis available for public comment for 60 days.

The risk analysis may be viewed on the Regulations.gov Web site or in our reading room (see ADDRESSES above for a link to Regulations.gov and information on the location and hours of the reading room). You may request paper copies of the risk analysis by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT . Please refer to the title of the risk analysis when requesting copies.

The International Cooperation on Harmonization of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) is a unique project conducted under the auspices of the World Organization for Animal Health that brings together the regulatory authorities of the European Union, Japan, and the United States and representatives from the animal health industry in the three regions. The purpose of VICH is to harmonize technical requirements for veterinary products (both drugs and biologics). Regulatory authorities and industry experts from Australia and New Zealand participate in an observer capacity. The World Federation of the Animal Health Industry (COMISA, the Confederation Mondiale de L'Industrie de la Sante Animale) provides the secretarial and administrative support for VICH activities.

The United States Government is represented in VICH by the Food and Drug Administration (FDA) and the Animal and Plant Health Inspection Service (APHIS). The FDA provides expertise on veterinary drugs, while APHIS fills a corresponding role for veterinary biological products. As VICH members, APHIS and FDA participate in efforts to enhance harmonization and have expressed their commitment to seeking scientifically based, harmonized technical requirements for the development of veterinary drugs and biological products. One of the goals of harmonization is to identify and reduce the differences in technical requirements for veterinary drugs and biologics among regulatory agencies in different countries.

The draft guideline “Target Animal Safety for Veterinary Live and Inactivated Vaccines” (VICH Topic GL44) has been made available by the VICH Steering Committee for comments by interested parties. The guideline is intended to provide guidance for designing and executing studies to evaluate the safety of the final formulation of veterinary live and inactivated vaccines prior to approval for licensing/registration. Because the draft guideline applies to some veterinary vaccines regulated by APHIS under the Virus-Serum-Toxin Act—particularly with regard to the safety of the dose of the vaccine on the health and welfare of the target animal—we are requesting comments on its provisions so that we may include any relevant public input on the draft in the Agency's comments to the VICH Steering Committee.

The draft guideline reflects current APHIS thinking regarding designing and executing studies to assess the safety of the final formulation of live and inactivated veterinary vaccines in target animals. In accordance with the VICH process, once a final draft of the document has been approved, the guideline will be recommended for adoption by the regulatory bodies of the European Union, Japan, and the United States. As with all VICH documents, each final guideline will not create or confer any rights for or on any person and will not operate to bind APHIS or the public. Further, the VICH guidelines specifically provide for the use of alternative approaches if those approaches satisfy applicable regulatory requirements.

Ultimately, APHIS intends to consider the VICH Steering Committee's final guideline for use by U.S. veterinary biologics licensees, permittees, and applicants. In addition, we may consider using the final guideline as the basis for proposed amendments to the regulations in 9 CFR chapter I, subchapter E (Viruses, Serums, Toxins, and Analogous Products; Organisms and Vectors). Because we anticipate that applicable provisions of the final versions of “Target Animal Safety for Veterinary Live and Inactivated Vaccines” may be introduced into APHIS' veterinary biologics regulatory program in the future, we encourage your comments on the draft guideline.

The draft guideline may be viewed on the Regulations.gov Web site or in our reading room (see ADDRESSES above for instructions for accessing Regulations.gov and information on the location and hours of the reading room). You may request paper copies of the draft guideline by calling or writing to the person listed under FOR FURTHER INFORMATION CONTACT .

The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered “regulated articles.” A permit must be obtained or a notification acknowledged before a regulated article may be introduced. The regulations set forth the permit application requirements and the notification procedures for the importation, interstate movement, or release in the environment of a regulated article.

On September 7, 2006, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 06-250-01r) from Oregon State University, in Corvallis, OR, for a controlled field release of genetically engineered Populus alba and Populus hybrids. A previous environmental assessment (EA) was prepared for a subset of trees in this release under Permit 95-031-01R. Under that permit, trees engineered with sterility constructs were allowed to flower. Since the researcher intends to add more trees to the permit and allow these additional trees to flower, this new EA has been prepared which updates the previous EA.

Permit application 06-250-01r describes 95 genetic constructs that can be categorized into reproductive sterility genes, genes affecting stature or light response, genes aimed to modify tree chemistry, and activation tagging mutants aimed at the development of “experimental domesticates.” These DNA sequences were introduced into Populus plants using disarmed Agrobacterium tumefaciens and also contain regulatory sequences from the plant pests cauliflower mosaic virus, tobacco mosaic virus, Aspergillus nidulans , and Agrobacterium tumefaciens . The subject Populus plants are considered regulated articles under the regulations in 7 CFR part 340 because they were created using donor sequences from plant pests.

On July 18, 2007, APHIS published a notice  1 in the Federal Register (72 FR 39378-39379, Docket No. APHIS-2007-0018) announcing the availability of an EA for controlled release of genetically engineered Populus species and hybrids. During the 30-day comment period, which ended on August 17, 2007, APHIS received five comments. Comments opposing the granting of the permit were submitted by two individuals and a public interest group. Comments supporting the granting of the permit were submitted by the permit applicant and a limited liability company. APHIS has addressed the issues raised during the comment period and has provided responses as an attachment to the finding of no significant impact (FONSI).

Pursuant to the regulations in 7 CFR part 340 promulgated under the Plant Protection Act, APHIS has determined that this field release will not pose a risk of introducing or disseminating a plant pest. Additionally, based upon analysis described in the EA, APHIS has determined that the action proposed in Alternative C of the EA, to issue the permit with supplemental permit conditions, will not have a significant impact on the quality of the human environment. You may read the FONSI and decision notice on the Internet or in the APHIS reading room (see ADDRESSES above). Copies may also be obtained from the person listed under FOR FURTHER INFORMATION CONTACT .

The EA and FONSI were prepared in accordance with (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered “regulated articles.” A permit must be obtained or a notification acknowledged before a regulated article may be introduced. The regulations set forth the permit application requirements and the notification procedures for the importation, interstate movement, or release in the environment of a regulated article.

On December 18, 2006, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 06-363-103r) from SemBioSys Genetics, Inc. of West Sacramento, CA, for a field trial using a line of transgenic safflower. Permit application 06-363-103r describes a transgenic safflower ( Carthamus tinctorius ) cultivar that has been genetically engineered to express a fusion protein consisting of oleosin from Arabidopsis thaliana and human proinsulin exclusively within its seeds. Expression of this fusion protein is controlled by the phaseolin promoter and terminator sequences from Phaseolus vulgaris L. (common bean). Constructs were inserted into the recipient organisms via a disarmed Agrobacterium tumefaciens vector system. The seeds from these safflower plants will be ground up and used for the development of proinsulin purification technology and are not for commercial production.

The subject safflower is considered a regulated article under the regulations in 7 CFR part 340 because it has been genetically engineered utilizing a recombinant DNA technique that uses a vector derived from Agrobacterium tumefaciens .

On June 22, 2007, APHIS published a notice  1 in the Federal Register (72 FR 34426-34427, Docket No. APHIS-2007-0023) announcing the availability of an environmental assessment (EA) for the proposed field release. During the 30-day comment period, APHIS received seven comments. There was one individual who was opposed to the use of biotechnology in food crops in general, but did not cite specific plant pest risk issues associated with this EA. Another commenter raised specific issues regarding the EA that mirrored the concerns of one of the five public interest groups that also sent in comments on the EA. In total, five public interest groups wrote letters in opposition to allowing the planting of this GE safflower. APHIS has responded to these comments in an attachment to the finding of no significant impact (FONSI).

Pursuant to the regulations in 7 CFR part 340 promulgated under the Plant Protection Act, APHIS has determined that this field release will not pose a risk of introducing or disseminating a plant pest. Additionally, based upon analysis described in the EA, APHIS has determined that the action proposed in Alternative B of the EA (the preferred alternative), to issue the permit with supplemental permit conditions, will not have a significant impact on the quality of the human environment. Therefore, APHIS has determined that a FONSI is appropriate for this proposed action. You may read the FONSI and decision notice on the Internet or in the APHIS reading room (see ADDRESSES above). Copies of the EA are also available from the individual listed under FOR FURTHER INFORMATION CONTACT .

The EA and FONSI were prepared in accordance with (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

This notice advises the public that the Animal and Plant Health Inspection Service (APHIS) has prepared a record of decision based on its supplemental environmental impact statement (SEIS) for the Importation of Solid Wood Packing Material Final Environmental Impact Statement, August 2003 (FEIS).

The SEIS and FEIS address Federal actions described in a final rule APHIS published in the Federal Register on September 16, 2004 (69 FR 55719-55733, Docket No. 02-032-3). The final rule amended the regulations for the importation of unmanufactured wood articles to adopt an international standard entitled “Guidelines for Regulating Wood Packaging Material in International Trade.” The FEIS was prepared with regard to that final rule in compliance with the National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), and its implementing regulations.

On October 24, 2006, APHIS published in the Federal Register (71 FR 62240, Docket No. APHIS-2006-0152) a notice of its intent to prepare the SEIS for the purpose of reevaluating and refining the estimates of methyl bromide usage associated with the alternatives considered in the FEIS. On March 9, 2007, the Environmental Protection Agency (EPA) published in the Federal Register (72 FR 10749) a notice of the availability of the draft SEIS. Comments were accepted on the draft SEIS until June 25, 2007.

In October 2007, APHIS published and distributed the final SEIS, which included discussion of the three comments received on the draft SEIS. On November 23, 2007, EPA published in the Federal Register (72 FR 65732) a notice of the availability of the final SEIS. The NEPA implementing regulations at 40 CFR 1506.10 require a 30-day waiting period between the time a final EIS is published and the time an agency makes a decision on an action covered by the EIS. APHIS did not receive any comments on the final SEIS by the time this waiting period ended on December 24, 2007.

APHIS has reviewed the final SEIS and has concluded that it has fully analyzed the issues covered by the draft SEIS and the comments and suggestions submitted by commenters. APHIS has now prepared a record of decision on the adopted SEIS and is making that record available to the public.

The Record of Decision for the Importation of Solid Wood Packing Material Supplement to the Final Environmental Impact Statement, prepared pursuant to the Council on Environmental Quality's NEPA implementing regulations at 40 CFR 1505.2, is set out below in its entirety.

The regulations in 7 CFR part 340, “Introduction of Organisms and Products Altered or Produced Through Genetic Engineering Which Are Plant Pests or Which There Is Reason to Believe Are Plant Pests,” regulate, among other things, the introduction (importation, interstate movement, or release into the environment) of organisms and products altered or produced through genetic engineering that are plant pests or that there is reason to believe are plant pests. Such genetically engineered organisms and products are considered “regulated articles.” A permit must be obtained or a notification acknowledged before a regulated article may be introduced. The regulations set forth the permit application requirements and the notification procedures for the importation, interstate movement, or release in the environment of a regulated article.

On December 21, 2005, the Animal and Plant Health Inspection Service (APHIS) received a permit application (APHIS No. 05-354-03r) from Planet Biotechnology, Inc., of Hayward, CA, for a field trial using a transgenic Nicotiana hybrid. Permit application 05-354-03r describes a Nicotiana hybrid line ( Nicotiana tabacum X Nicotiana glauca ), designated as 06PBCarHG1, that produces a chimeric antimicrobial antibody (trade name CaroRx TM ) that binds to the bacterium ( Streptococcus mutans ) associated with tooth decay in humans. Expression of the gene sequence is controlled by the cauliflower mosaic virus (CaMV) promoter and terminated by NOS from Agrobacterium tumefaciens and utilizes the selectable marker NPTII from Escherichia coli . Constructs were inserted into the recipient organisms via a disarmed Agrobacterium tumefaciens vector system. The antibodies generated from this planting will be extracted after harvest.

The subject Nicotiana hybrid is considered a regulated article under the regulations in 7 CFR part 340 because it has been genetically engineered using genetic sequences from plant pathogens.

On June 13, 2007, APHIS published a notice  1 in the Federal Register (72 FR 32607-32608, Docket No. APHIS-2007-0029) announcing the availability of an environmental assessment (EA) for the proposed release of a transgenic Nicotiana hybrid line. During the 30-day comment period, APHIS received six comments. All six comments were opposed to APHIS' issuance of this permit and genetically engineered crops in general, but only one raised specific issues regarding the EA. APHIS has provided responses to these comments as an attachment to the finding of no significant impact (FONSI).

Pursuant to the regulations promulgated under the Plant Protection Act, APHIS has determined that this field release will not pose a risk of introducing or disseminating a plant pest. Additionally, based upon analysis described in the EA, APHIS has determined that the action proposed in Alternative B of the EA (the preferred alternative), to issue the permit with supplemental permit conditions, will not have a significant impact on the quality of the human environment. Therefore, APHIS has determined that a FONSI is appropriate for this proposed action. You may read the FONSI and Decision Notice on the Internet or in the APHIS reading room (see ADDRESSES above). Copies may also be obtained from the person listed under the FOR FURTHER INFORMATION CONTACT section of this notice.

The EA and FONSI were prepared in accordance with (1) The National Environmental Policy Act of 1969 (NEPA), as amended (42 U.S.C. 4321 et seq. ), (2) regulations of the Council on Environmental Quality for implementing the procedural provisions of NEPA (40 CFR parts 1500-1508), (3) USDA regulations implementing NEPA (7 CFR part 1b), and (4) APHIS' NEPA Implementing Procedures (7 CFR part 372).

GIPSA is publishing this notice to correct an error concerning the date to submit applications for designation or to comment on the current official agencies serving the Georgia, Cedar Rapids (IA), and Montana areas.

In the Federal Register issue of Monday, December 3, 2007, beginning on page 67885 (72 FR 67885) in make the following correction:

1. On page 67885, in the second column, delete the date January 2, 2009, and insert the date February 25, 2008. This action corrects the date, and allows an additional period for late applications and comments.

This Action has been reviewed and determined not to be a rule or regulation as defined in Executive Order 12866 and Departmental Regulation 1512-1; therefore, the Executive Order and Departmental Regulation do not apply to this action.

In the December 5, 2007, Federal Register (72 FR 68555), GIPSA asked persons interested in providing official services in Maryland, New Jersey, and New York to submit an application for designation.

There were four applicants for the Maryland, New Jersey, and New York areas open for designation: Kankakee, Mid-Iowa, and Schaal, all currently designated official agencies, and Maryland, a state organization not currently designated. Kankakee and Mid-Iowa applied for Maryland, New Jersey, and New York. Schaal applied for New Jersey and New York. Maryland applied for Maryland.

GIPSA is publishing this notice to provide interested persons the opportunity to present comments concerning the applicants. Commenters are encouraged to submit reasons and pertinent data for support or objection to the designation of the applicants. All comments must be submitted to the Compliance Division at the above address or at http://www.regulations.gov . Comments and other available information will be considered in making a final decision. GIPSA will publish notice of the final decision in the Federal Register , and GIPSA will send the applicants written notification of the decision.

The Council will convene the LEAP to review a generic amendment that would potentially allow offshore aquaculture in the Gulf of Mexico. The LEAP will also review Amendment 30B to the Reef Fish Fishery FMP that may establish additional restrictions on harvest of gag to maintain the rebuilding plan for this overfished stock and relax restriction on red grouper based on favorable analyses from the last stock assessment. Furthermore, the LEAP will review Draft Amendment 29 to the Reef Fish FMP that could establish a grouper/tilefish limited access privilege program (LAPP) or individual fishing quota (IFQ) program. Finally, the LEAP will receive a presentation on the potential for new marine protected areas (MPAs), and review a draft offshore aquaculture bill.

The LEAP consists of principal law enforcement officers in each of the Gulf States, as well as the NMFS, U.S. Fish and Wildlife Service (FWS), the U.S. Coast Guard, and the NOAA General Counsel. A copy of the agenda and related materials can be obtained by calling the Council office at (813) 348-1630.

Although other non-emergency issues not on the agendas may come before the LEAP for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), those issues may not be the subject of formal action during this meeting. Actions of the LEAP will be restricted to those issues specifically identified in the agendas and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take action to address the emergency.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Tina Trezza at the Council (see ADDRESSES ) 5 working days prior to the meeting.

The PNCIAC will review the Bering Sea Aleutian Island king and Tanner Crab fisheries proposals to be acted upon at the March 3-9, 2008, Alaska Board of Fisheries meeting in Anchorage, AK; informational update and discussion of the NPFMC motion on Economic Data Report.

This meeting is physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to Gail Bendixen, (907) 271-2809, at least 5 working days prior to the meeting date.

The LAP Program Workgroup will provide a presentation to the LAP Program Committee on its final report and recommendations regarding a Limited Access Privilege Program for the commercial snapper grouper fishery in the Council's area of jurisdiction.

The Redstone Consulting Group will provide a presentation on Limited Access Privilege Programs.

The LAP Program Committee will discuss LAP Programs, possible actions, timing issues, and provide directions to staff.

The Executive and Finance Committees will meet to review the final Calendar Year (CY) Council budget, the CY 2008-2010 FMP/Amendment/Framework timelines and modify as appropriate. The Committees will also receive a report on the President's Fiscal Year 2009 budget and review and develop comments on H.R. Bill 4087 introduced by Congressman Jones from North Carolina.

The Snapper Grouper Committee will review public hearing comments on Amendment 15B to the Snapper Grouper FMP and modify the amendment as necessary. The Committee will then approve a recommendation that the Council submit Amendment 15B to the Secretary of Commerce for review and approval. Amendment 15B includes actions to modify current recreational sale allowances, define allocations for snowy grouper and red porgy, implement a plan to monitor and assess bycatch, implement measures to minimize the impacts of incidental take on sea turtles and small tooth sawfish, modify commercial permit renewal and transferability requirements, and update management reference points for golden tilefish.

The Snapper Grouper Committee will also review Amendment 16 to the Snapper Grouper FMP, modify as appropriate, and approve the amendment for public hearings. Amendment 16 includes measures to end overfishing for gag grouper and vermilion snapper. The Committee will also review and discuss public scoping comments on Amendment 17 and provide directions to staff on options to be developed. Amendment 17 includes measures to respond to stock assessments for red snapper, greater amberjack, and mutton snapper, specify Annual Catch Limits for species in the snapper grouper fishery management unit currently undergoing overfishing, specify Accountability Measures as appropriate, extend the management unit through the Mid-Atlantic Council's area of jurisdiction, and other items. The Committee will also receive a report on a pre-closure survey of proposed Marine Protected Areas, and an update on spearfishing issues at Gray's Reef National Marine Sanctuary.

The Law Enforcement Advisory Panel (AP) will meet to discuss law enforcement's role in the development of a LAP Program. The AP will also discuss and comment on the following issues: snapper grouper amendment issues, spiny lobster issues and a future amendment, open water aquaculture, circle hook enforcement, special management areas, and the sale of recreationally caught fish.

The Habitat and Ecosystem-based Management Committees will receive a presentation on Vessel Monitoring Systems and review input received from the Habitat, Coral, Deepwater Shrimp and Golden Crab Advisory Panels regarding the Fishery Ecosystem Plan (FEP) Comprehensive Amendment, modify as needed, and approve the amendment for public hearings. The Committee will also review the FEP and approve for public hearing. In addition, the Committee will review and comment on proposed critical habitat for staghorn and elkhorn corals, review and approve the Council's Energy Policy, receive a report on deepwater coral research, and discuss habitat issues as necessary.

The Spiny Lobster Committee will review the scoping comments on the Generic Import Amendment to the Spiny Lobster FMP. The amendment addresses regulations regarding the importation of spiny lobster. The Committee will also review the status of changes to lobster regulations by the State of Florida, and plan a timeline for an amendment to address Annual Catch Limits for spiny lobster.

The Shrimp Committee will review scoping comments regarding Amendment 7 to the Shrimp FMP and provide directions to staff regarding options to be included in the amendment. Amendment 7 addresses landings requirements currently in place for South Atlantic endorsements for rock shrimp permits.

The Allocation Committee will review public scoping comments and provide direction to staff regarding options to include in a Comprehensive Allocation Amendment. The amendment will address allocations between recreational and commercial sectors and possible allocations within those sectors.

The SOPPs Committee will receive an update on the status of Secretarial review of the Council's SOPPs and develop changes as necessary.

The SSC Selection Committee will meet in closed session and discuss any guidance from the National Marine Fisheries Service (NMFS) affecting the SSC resulting from the reauthorized Magnuson-Stevens Act amendments. The Committee will also review applicants and provide recommendations for appointments as appropriate.

The Personnel Committee will meet in closed session to discuss personnel issues.

From 8 a.m. - 8:15 a.m. , the Council will call the meeting to order, adopt the agenda, and approve the December 2007 meeting minutes.

From 8:15 a.m. - 8:45 a.m. , the Council will receive a report from the Snapper Grouper Committee, take public comment on Amendment 15B, and approve Amendment 15B for submission to the Secretary of Commerce for review and approval. The Council will also approve Amendment 16 for public hearings and take actions regarding Committee recommendations as appropriate.

Note: The Council will take final public comment on Amendment 15B to the Snapper Grouper Fishery Management Plan at 8:15 a.m. on March 7, 2008.

From 8:45 a.m. - 9 a.m. , the Council will receive a report from the LAP Program Committee and take action as appropriate.

From 9 a.m. - 9:15 a.m. , the Council will receive a report from the Joint Habitat and Ecosystem-Based Management Committees. The Council will approve the FEP and the FEP Comprehensive Amendment for public hearings. The Council will consider other Committee recommendations and take action as appropriate.

From 9:15 a.m. - 9:30 a.m. , the Council will receive a report from the Joint Executive and Finance Committees and take action as appropriate.

From 9:30 a.m. - 9:45 a.m. , the Council will receive a report from the Spiny Lobster Committee take action as appropriate.

From 9:45 a.m. - 10 a.m. , the Council will receive a report from the Shrimp Committee and take action as appropriate.

From 10 a.m. - 10:15 a.m. , the Council will receive a report from the Allocation Committee and take action as appropriate.

From 10:15 a.m. - 10:30 a.m. , the Council will receive a report from the SOPPs Committee and take action as appropriate.

From 10:30 a.m. - 10:45 a.m. , the Council will receive a report from the SSC Selection Committee and take action as appropriate.

From 10:45 - 12:30 p.m. , the Council will receive a report regarding the Council Coordinating Committee Meeting, receive status reports from NOAA Fisheries' Southeast Regional Office, NOAA Fisheries' Southeast Fisheries Science Center, agency and liaison reports, review Experimental Fishing Permit applications as necessary, and discuss other business including upcoming meetings.

Documents regarding these issues are available from the Council office (see ADDRESSES ).

Although non-emergency issues not contained in this agenda may come before this Council for discussion, those issues may not be the subjects of formal Council action during this meeting. Council action will be restricted to those issues specifically listed in this notice and any issues arising after publication of this notice that require emergency action under section 305 (c) of the Magnuson-Stevens Act, provided the public has been notified of the Council's intent to take final action to address the emergency.

Except for advertised (scheduled) public hearings and public comment, the times and sequence specified on this agenda are subject to change.

These meetings are physically accessible to people with disabilities. Requests for sign language interpretation or other auxiliary aids should be directed to the Council office (see ADDRESSES ) by February 29, 2008.

The Proposed Action is to designate areas where mid- and high-frequency active sonar and the IEER system training, maintenance, and RDT&E activities will occur, and to conduct these activities. AFAST training and RDT&E activities involving active sonar and the IEER system are collectively described as active sonar activities in the AFAST Draft EIS/OEIS. These active sonar activities are not new and do not involve significant changes in systems, tempo, or intensity from past activities. The purpose of the Proposed Action is to provide active sonar training for U.S. Navy Atlantic Fleet ship, submarine, and aircraft crews, and to conduct RDT&E activities to support the requirements of the Fleet Readiness Training Plan (FRTP) and stay proficient in Anti-Submarine Warfare (ASW) and Mine Warfare (MIW) skills. The FRTP is the Navy's training cycle that requires naval forces to build up in preparation for operational deployment and to maintain a high level of proficiency and readiness while deployed.

The FRTP requires Basic Unit Level Training (ULT), Intermediate ULT, and Sustainment Training. The Navy meets these requirements during Independent ULT, Coordinated ULT, and Strike Group Training. At the beginning of the cycle, basic combat skills are learned and practiced during basic Independent ULT activities. Basic skills are then refined during Coordinated ULT. Strike Group Training is integrated training using progressively more difficult, complex, and large-scale exercises conducted at an increasing tempo. This training provides the warfighter with the skills necessary to function as part of a coordinated fighting force in a hostile environment with the capacity to accomplish multiple missions.

Surface ships and submarines participating in the training also must conduct active sonar maintenance pier side and during transit to the training exercise location. The active sonar maintenance is required to ensure that the sonar system is operating properly before engaging in the training exercise or when the sonar systems are suspected of operating at levels below optimal performance.

Additionally, RDT&E provides the Navy the capability of developing new active sonar systems and ensuring their safe and effective implementation for the Atlantic Fleet. The RDT&E activities analyzed in the AFAST Draft EIS/OEIS are similar to, and coincident with, Atlantic Fleet training events and have not been previously evaluated in other environmental planning documents.

The Navy's need for training and RDT&E is found in Title 10 of the USC, Section 5062 (10 U.S.C. 5062). Title 10 U.S.C. 5062 requires the Navy to be “organized, trained, and equipped primarily for prompt and sustained combat incident to operations at sea.” The current and emerging training and RDT&E activities addressed in this Draft EIS/OEIS are conducted in fulfillment of this legal requirement.

The Draft EIS/OEIS evaluates the potential environmental impacts of four alternatives. Under Alternative 1, Designate Fixed Active Sonar Areas, fixed active sonar areas would be designated using an environmental analysis to determine locations that would minimize environmental effects to biological resources while still meeting operational requirements. These areas would be available for use year-round. Under Alternative 2, Designate Seasonal Active Sonar Areas, active sonar training areas would be designated using the same environmental analysis conducted under Alternative 1. The areas would be adjusted seasonally to minimize effects to marine resources while still meeting minimum operational requirements. Under Alternative 3, Designate Areas of Increased Awareness, the results of the environmental analysis conducted for Alternative 1 and 2 were used in conjunction with a qualitative environmental analysis of sensitive habitats to identify areas of increased awareness. Active sonar would not be conducted within these areas of increased awareness. The No Action Alternative can be regarded as continuing with the present course of action. Under the No Action Alternative, the Navy would continue conducting active sonar activities within and adjacent to existing OPAREAs rather than designate active sonar areas or areas of increased awareness. The No Action Alternative is the Navy's Operationally Preferred Alternative.

The Navy analyzed potential impacts on multiple resources including, but not limited to, the marine environment, marine life, and socioeconomic resources. No significant adverse impacts are identified for any resource area in any geographic location within the AFAST Study Area that cannot be mitigated, with the exception of exposure of marine mammals and sea turtles to underwater sound. NMFS has received a request for Letter of Authorization (LOA) in accordance with the Marine Mammal Protection Act to authorize the incidental take of marine mammals that may result from the implementation of the activities analyzed in the AFAST Draft EIS/OEIS. In addition, the AFAST Draft EIS/OEIS will serve as the Biological Evaluation (BE) to enter into consultation with NMFS in accordance with Section 7 of the Endangered Species Act (ESA) to authorize the incidental take of endangered or threatened marine mammals and sea turtles that may result from the implementation of the activities analyzed in the AFAST Draft EIS/OEIS. ESA consultation is complete once NMFS prepares a final Biological Opinion and issues an incidental take statement.

The AFAST Draft EIS/OEIS was distributed to Federal, State, and local agencies, elected officials, and other interested individuals and organizations on February 8, 2007. The public comment period will end on March 31, 2008. Copies of the AFAST Draft EIS/OEIS are available for public review at the following libraries: Portland Public Library, 5 Monument Square, Portland, Maine; New London Public Library, 63 Huntington Street, New London, Connecticut; Kirn Memorial Library, 301 East City Hall Avenue, Norfolk, Virginia; Carteret County Public Library, 210 Turner Street, Morehead City, North Carolina; Charleston County Public Library, 68 Calhoun Street, Charleston, South Carolina; Jacksonville Public Library, 303 North Laura Street, Jacksonville, Florida; Bay County Public Library, 25 West Government Street, Panama City, Florida; Corpus Christi Public Library—Central Library, 805 Comanche, Corpus Christi, Texas; Boston Public Library—Central Library, 700 Boylston Street, Boston, Massachusetts; Ann Arundel County Public Library, 1410 West Street, Annapolis, Maryland; and Camden County Public Library, 1410 Highway 40 East, Kingsland, Georgia.

The AFAST Draft EIS/OEIS is also available for electronic public viewing at http://afasteis.gcsaic.com . A paper copy of the Executive Summary or a single CD with the AFAST Draft EIS/OEIS will be made available upon written request by contacting Naval Facilities Engineering Command, Atlantic, Attention: Code EV22 (Atlantic Fleet Sonar Project Manager), 6506 Hampton Boulevard, Norfolk, Virginia 23508-1278, Fax: 888-875-6781.

Federal, State, and local agencies and interested parties are invited to be present or represented at the public hearing. Written comments can also be submitted during the open house sessions preceding the public hearings. Oral statements will be heard and transcribed by a stenographer; however, to ensure the accuracy of the record, all statements should be submitted in writing. All statements, both oral and written, will become part of the public record on the Draft EIS/OEIS and will be responded to in the Final EIS/OEIS. Equal weight will be given to both oral and written statements.

In the interest of available time, and to ensure all who wish to give an oral statement have the opportunity to do so, each speaker's comments will be limited to three (3) minutes. If a long statement is to be presented, it should be summarized at the public hearing with the full text submitted either in writing at the hearing, or mailed or faxed to Naval Facilities Engineering Command, Atlantic, Attention: Code EV22 (Atlantic Fleet Sonar Project Manager), 6506 Hampton Boulevard, Norfolk, Virginia 23508-1278, Fax: 888-875-6781. In addition, comments may be submitted on-line at http://afasteis.gcsaic.com during the comment period. All written comments must be postmarked by March 31, 2008 to ensure they become part of the official record. All comments will be addressed in the Final EIS/OEIS.

Section 3506 of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35) requires that the Office of Management and Budget (OMB) provide interested Federal agencies and the public an early opportunity to comment on information collection requests. OMB may amend or waive the requirement for public consultation to the extent that public participation in the approval process would defeat the purpose of the information collection, violate State or Federal law, or substantially interfere with any agency's ability to perform its statutory obligations. The IC Clearance Official, Regulatory Information Management Services, Office of Management, publishes that notice containing proposed information collection requests prior to submission of these requests to OMB. Each proposed information collection, grouped by office, contains the following: (1) Type of review requested, e.g. new, revision, extension, existing or reinstatement; (2) Title; (3) Summary of the collection; (4) Description of the need for, and proposed use of, the information; (5) Respondents and frequency of collection; and (6) Reporting and/or Recordkeeping burden. OMB invites public comment.

The Department of Education is especially interested in public comment addressing the following issues: (1) Is this collection necessary to the proper functions of the Department; (2) will this information be processed and used in a timely manner; (3) is the estimate of burden accurate; (4) how might the Department enhance the quality, utility, and clarity of the information to be collected; and (5) how might the Department minimize the burden of this collection on the respondents, including through the use of information technology.

Type of Review: Extension.

Title: Guide for the Development of a State Plan under the Adult Education and Family Literacy Act (Title II of the Workforce Investment Act of 1998).

Frequency: Annually.

Affected Public: State, Local, or Tribal Gov't, SEAs or LEAs.

Reporting and Recordkeeping Hour Burden:

Responses: 59.

Burden Hours: 2,655.

Abstract: The Adult Education and Family Literacy Act (AEFLA), Title II of the Workforce Investment Act of 1998 (WIA), Public Law 105-220 provides formula funding to States to support adult education instruction at the State level. Section 224 of Public Law 105-220 required States submit to the Department their plan for how they address the requirements of the Act, including agreeing upon levels of performance identified in section 212. Congress did not enact new legislation prior to the expiration of the law in 2003, however, they continue to extend program appropriations for each additional year in annual appropriation laws, respectively. While it is unlikely that Congress will reauthorize the expired Workforce Investment Act of 1998 (WIA) this year, appropriations for FY 2008 was signed into law by the President on December 27, 2007. This Guide will continue to, as it has since the expiration of WIA advise States on how to continue their Adult Education programs. Requests for copies of the proposed information collection request may be accessed from http:// edicsweb.ed.gov, by selecting the “Browse Pending Collections” link and by clicking on link number 3591. When you access the information collection, click on “Download Attachments” to view. Written requests for information should be addressed to U.S. Department of Education, 400 Maryland Avenue, SW., LBJ, Washington, DC 20202-4537. Requests may also be electronically mailed to ICDocketMgr@ed.gov or faxed to 202-401-0920. Please specify the complete title of the information collection when making your request.

Comments regarding burden and/or the collection activity requirements should be electronically mailed to ICDocketMgr@ed.gov. Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.

Purpose of the Committee: The purpose of the Ultra-Deepwater Advisory Committee is to provide advice on development and implementation of programs related to onshore unconventional natural gas and other petroleum resources to the Secretary of Energy; and provide comments and recommendations and priorities for the Department of Energy Annual Plan per requirements of the Energy Policy Act of 2005, Subtitle J, section 999.

Tentative Agenda

Public Participation: The meeting is open to the public. The Designated Federal Officer, the Chairman of the Committee and a Facilitator will lead the meeting for the orderly conduct of business. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of the items on the agenda, you should contact Elena Melchert or Bill Hochheiser at the address or telephone number listed above. You must make your request for an oral statement at least five business days prior to the meeting, and reasonable provisions will be made to include the presentation on the agenda. Public comment will follow the 3 minute rule.

Minutes: The minutes of this meeting will be available for public review and copying within 60 days at the Freedom of Information Public Reading Room, Room 1E-190, Forrestal Building, 1000 Independence Avenue, SW., Washington, DC, between 9 a.m. and 4 p.m., Monday through Friday, except federal holidays.

Purpose of the Committee: The purpose of the Ultra-Deepwater Advisory Committee is to provide advice on development and implementation of programs related to onshore unconventional natural gas and other petroleum resources to the Secretary of Energy; and provide comments and recommendations and priorities for the Department of Energy Annual Plan per requirements of the Energy Policy Act of 2005, Subtitle J, section 999.

Public Participation: The meeting is open to the public. The Designated Federal Officer, the Chairman of the Committee and a Facilitator will lead the meeting for the orderly conduct of business. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of the items on the agenda, you should contact Elena Melchert or Bill Hochheiser at the address or telephone number listed above. You must make your request for an oral statement at least five business days prior to the meeting, and reasonable provisions will be made to include the presentation on the agenda. Public comment will follow the 10-minute rule.

Minutes: The minutes of this meeting will be available for public review and copying within 60 days at the Freedom of Information Public Reading Room, Room 1E-190, Forrestal Building, 1000 Independence Avenue, SW., Washington, DC, between 9 a.m. and 4 p.m., Monday through Friday, except federal holidays.

Purpose of the Committee: The purpose of the Unconventional Resources Technology Advisory Committee is to provide advice on development and implementation of programs related to onshore unconventional natural gas and other petroleum resources to the Secretary of Energy; and provide comments and recommendations and priorities for the Department of Energy Annual Plan per requirements of the Energy Policy Act of 2005, Subtitle J, section 999.

Public Participation: The meeting is open to the public. The Designated Federal Officer, the Chairman of the Committee and a Facilitator will lead the meeting for the orderly conduct of business. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of the items on the agenda, you should contact Elena Melchert or Bill Hochheiser at the address or telephone number listed above. You must make your request for an oral statement at least five business days prior to the meeting, and reasonable provisions will be made to include the presentation on the agenda. Public comment will follow the 3 minute rule.

Minutes: The minutes of this meeting will be available for public review and copying within 60 days at the Freedom of Information Public Reading Room, Room 1E-190, Forrestal Building, 1000 Independence Avenue, SW., Washington, DC, between 9 a.m. and 4 p.m., Monday through Friday, except federal holidays.

Purpose of the Committee: The purpose of the Unconventional Resources Technology Advisory Committee is to provide advice on development and implementation of programs related to onshore unconventional natural gas and other petroleum resources to the Secretary of Energy; and provide comments and recommendations and priorities for the Department of Energy Annual Plan per requirements of the Energy Policy Act of 2005, Subtitle J, Section 999.

Public Participation: The meeting is open to the public. The Designated Federal Officer, the Chairman of the Committee and a Facilitator will lead the meeting for the orderly conduct of business. If you would like to file a written statement with the Committee, you may do so either before or after the meeting. If you would like to make oral statements regarding any of the items on the agenda, you should contact Elena Melchert or Bill Hochheiser at the address or telephone number listed above. You must make your request for an oral statement at least five business days prior to the meeting, and reasonable provisions will be made to include the presentation on the agenda. Public comment will follow the 10 minute rule.

Minutes: The minutes of this meeting will be available for public review and copying within 60 days at the Freedom of Information Public Reading Room, Room 1E-190, Forrestal Building, 1000 Independence Avenue, SW., Washington, DC, between 9 a.m. and 4 p.m., Monday through Friday, except federal holidays.

How Can I Access the Docket and/or Submit Comments?

EPA has established a public docket for this ICR under Docket ID No. EPA-HQ-OW-2007-1197, which is available for online viewing at http://www.regulations.gov, or in person viewing at the Water Docket in the EPA Docket Center (EPA/DC), EPA West, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA/DC Public Reading Room is open from 8 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Reading Room is 202-566-1744, and the telephone number for the Water Docket is 202-566-2426.

Use http://www.regulations.gov to obtain a copy of the draft collection of information, submit or view public comments, access the index listing of the contents of the docket, and to access those documents in the public docket that are available electronically. Once in the system, select “search,” then key in the docket ID number identified in this document.

Pursuant to section 3506(c)(2)(A) of the PRA, EPA specifically solicits comments and information to enable it to:

(i) Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Agency, including whether the information will have practical utility;

(ii) evaluate the accuracy of the Agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;

(iii) enhance the quality, utility, and clarity of the information to be collected; and

(iv) minimize the burden of the collection of information on those who are to respond, including through the use of appropriate automated electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g. , permitting electronic submission of responses. In particular, EPA is requesting comments from very small businesses (those that employ less than 25) on examples of specific additional efforts that EPA could make to reduce the paperwork burden for very small businesses affected by this collection.

You may find the following suggestions helpful for preparing your comments:

1. Explain your views as clearly as possible and provide specific examples.

2. Describe any assumptions that you used.

3. Provide copies of any technical information and/or data you used that support your views.

4. If you estimate potential burden or costs, explain how you arrived at the estimate that you provide.

5. Offer alternative ways to improve the collection activity.

6. Make sure to submit your comments by the deadline identified under DATES .

7. To ensure proper receipt by EPA, be sure to identify the docket ID number assigned to this action in the subject line on the first page of your response. You may also provide the name, date, and Federal Register citation.

Affected entities: Entities potentially affected by this action are new and existing public water systems (PWS), primacy agencies, and EPA.

Title: Disinfectants/Disinfection Byproducts, Chemical and Radionuclides Rules Renewal Information Collection Request (ICR).

ICR numbers: EPA ICR No. 1896.08, OMB Control No. 2040-0204.

ICR status: This ICR is currently scheduled to expire on June 30, 2008. An Agency may not conduct or sponsor, and a person is not required to respond to, a collection of information, unless it displays a currently valid OMB control number. The OMB control numbers for EPA's regulations in title 40 of the CFR, after appearing in the Federal Register when approved, are listed in 40 CFR part 9, are displayed either by publication in the Federal Register or by other appropriate means, such as on the related collection instrument or form, if applicable. The display of OMB control numbers in certain EPA regulations is consolidated in 40 CFR part 9.

Abstract: The Disinfectants/Disinfection Byproducts, Chemical and Radionuclides Rules ICR examines PWS, primacy agency and EPA burden and costs for recordkeeping and reporting requirements in support of the chemical drinking water regulations. These recordkeeping and reporting requirements are mandatory for compliance with 40 CFR parts 141 and 142. The following chemical regulations are included: The Stage 1 Disinfectants and Disinfection Byproducts Rule (Stage 1 DBPR), the Stage 2 Disinfectants and Disinfection Byproducts Rule (Stage 2 DBPR), the Chemical Phase Rules (Phases II/IIB/V), the 1976 Radionuclides Rule and 2000 Radionuclides Rule, the Total Trihalomethanes (TTHM) Rule, the Disinfectant Residual Monitoring and Associated Activities under the Surface Water Treatment Rule, the Arsenic Rule, and the Short-Term Revisions to the Lead and Copper Rule (LCR). Future chemical-related rulemakings, such as Radon, will be added to this consolidated ICR after the regulations are finalized and the initial, rule-specific, ICRs are due to expire.

Burden Statement: The annual public reporting and recordkeeping burden for this collection of information is estimated to average 0.40 hours per response. Burden means the total time, effort, or financial resources expended by persons to generate, maintain, retain, or disclose or provide information to or for a Federal agency. This includes the time needed to review instructions; develop, acquire, install, and utilize technology and systems for the purposes of collecting, validating, and verifying information, processing and maintaining information, and disclosing and providing information; adjust the existing ways to comply with any previously applicable instructions and requirements which have subsequently changed; train personnel to be able to respond to a collection of information; search data sources; complete and review the collection of information; and transmit or otherwise disclose the information.

The ICR provides a detailed explanation of the Agency's estimate, which is only briefly summarized here:

Estimated total number of potential respondents: 161,274.

Frequency of response: Varies by requirement (i.e., on occasion, monthly, quarterly, semi-annually, annually, biennially, and every 3, 6, and 9 years).

Estimated total average number of responses for each respondent: 112.

Estimated total annual burden hours: 6,944,275 hours.

Estimated total annualized capital/startup costs: $6,918,000.

Estimated total annual maintenance and operational costs: $197,945,204.

There is an increase of about 262,962 hours in the total estimated respondent burden compared with that identified in the ICR currently approved by OMB. This increase is primarily due to restructuring adjustments (i.e., incorporation of the approved burden hours from the previously stand-alone ICRs for the Stage 2 DBPR and the Revisions to the LCR rules).

EPA will consider the comments received and amend the ICR as appropriate. The final ICR package will then be submitted to OMB for review and approval pursuant to 5 CFR 1320.12. At that time, EPA will issue another Federal Register notice pursuant to 5 CFR 1320.5(a)(1)(iv) to announce the submission of the ICR to OMB and the opportunity to submit additional comments to OMB. If you have any questions about this ICR or the approval process, please contact the technical person listed under FOR FURTHER INFORMATION CONTACT .

Section 303(d) of the Clean Water Act (CWA) requires that each state identify those waters for which existing technology-based pollution controls are not stringent enough to attain or maintain state water quality standards. For those waters, states are required to establish Total Maximum Daily Loads (TMDLs) according to a priority ranking.

EPA's Water Quality Planning and Management regulations include requirements related to the implementation of section 303(d) of the CWA (40 CFR 130.7). The regulations require states to identify water quality limited waters still requiring TMDLs every 2 years. The list of waters still needing TMDLs must also include priority rankings and must identify the waters targeted for TMDL development during the next two years (40 CFR 130.7).

Consistent with EPA's regulations, Louisiana submitted to EPA its 2006 listing decisions under section 303(d) on February 12, 2007. On October 19, 2007, EPA approved Louisiana's 2006 listing of 347 water body-pollutant combinations and associated priority rankings. EPA disapproved Louisiana's 2006 listing decisions not to list 136 water quality limited segments. EPA identified these additional waters and pollutants along with priority rankings for inclusion on the 2006 section 303(d) Lists.

IRIS is a database that contains potential adverse human health effects information that may result from chronic (or lifetime) exposure to specific chemical substances found in the environment. The database (available on the Internet at http://www.epa.gov/iris ) contains qualitative and quantitative health effects information for more than 540 chemical substances that may be used to support the first two steps (hazard identification and dose-response evaluation) of a risk assessment process. When supported by available data, the database provides oral reference doses (RfDs) and inhalation reference concentrations (RfCs) for chronic health effects, and oral slope factors and inhalation unit risks for carcinogenic effects. Combined with specific exposure information, government and private entities can use IRIS data to help characterize public health risks of chemical substances in a site-specific situation and thereby support risk management decisions designed to protect public health.

Submit your comments, identified by Docket ID No. EPA-HQ-ORD-2008-0057 by one of the following methods:

• http://www.regulations.gov: Follow the on-line instructions for submitting comments.

• E-mail: ORD.Docket@epa.gov.

• Fax: 202-566-1753.

• Mail: Office of Environmental Information (OEI) Docket (Mail Code: 2822T), U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460. The phone number is 202-566-1752.

• Hand Delivery: The OEI Docket is located in the EPA Headquarters Docket Center, EPA West Building, Room 3334, 1301 Constitution Ave., NW., Washington, DC. The EPA Docket Center Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is 202-566-1744. Such deliveries are only accepted during the docket's normal hours of operation, and special arrangements should be made for deliveries of boxed information.

If you provide comments by e-mail or hand delivery, please submit one unbound original with pages numbered consecutively, and three copies of the comments. For attachments, provide an index, number pages consecutively with the comments, and submit an unbound original and three copies.

Instructions: Direct your comments to Docket ID No. EPA-HQ-ORD-2008-0057. Please ensure that your comments are submitted within the specified comment period. Comments received after the closing date will be marked “late,” and may only be considered if time permits. It is EPA's policy to include all comments it receives in the public docket without change and to make the comments available online at http://www.regulations.gov, including any personal information provided, unless a comment includes information claimed to be Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Do not submit information that you consider to be CBI or otherwise protected through http://www.regulations.gov or e-mail. The http://www.regulations.gov Web site is an “anonymous access” system, which means EPA will not know your identity or contact information unless you provide it in the body of your comment. If you send an e-mail comment directly to EPA without going through http://www.regulations.gov, your e-mail address will be automatically captured and included as part of the comment that is placed in the public docket and made available on the Internet. If you submit an electronic comment, EPA recommends that you include your name and other contact information in the body of your comment and with any disk or CD-ROM you submit. If EPA cannot read your comment due to technical difficulties and cannot contact you for clarification, EPA may not be able to consider your comment. Electronic files should avoid the use of special characters, any form of encryption, and be free of any defects or viruses. For additional information about EPA's public docket visit the EPA Docket Center homepage at http://www.epa.gov/epahome/dockets.htm.

Docket: All documents in the docket are listed in the http://www.regulations.gov index. Although listed in the index, some information is not publicly available, e.g., CBI or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, will be publicly available only in hard copy. Publicly available docket materials are available either electronically in http://www.regulations.gov or in hard copy at the OEI Docket in the EPA Headquarters Docket Center.

I. Background

On October 13, 2006, the President signed into law the FSRRA, Public Law No. 109-351. The stated purpose of the law is to reduce regulatory burden and improve productivity for insured depository institutions. Many of the provisions of this law amended statutes that the FDIC administers. One of those statutes is the Bank Merger Act. 1 In addition, the Federal Deposit Insurance Reform Act of 2005 (“FDIRA”)  2 consolidated the SAIF and the BIF into the Deposit Insurance Fund. As a result, the FDIC is amending its Statement of Policy  3 to conform it to the Bank Merger Act, as amended by FSRRA, and to the changes made by FDIRA. The FDIC is not seeking comment on the amendments that it is making to the Statement of Policy, and the amendments are effective upon publication in the Federal Register .

Four Federal banking agencies must utilize the Bank Merger Act to approve merger transactions subject to their respective jurisdiction; those agencies are the FDIC, the Federal Reserve Board (“FRB”), the Office of the Comptroller of the Currency (“OCC”), and the Office of Thrift Supervision (“OTS”). Prior to FSRRA, the Federal banking agency responsible for processing a particular merger application had to request and obtain a competitive factors report from each of the other three Federal banking agencies. Section 606 of FSRRA amended section 18(c)(4) of the Federal Deposit Insurance Act (“FDI Act”), 12 U.S.C. 1828(c)(4), to eliminate that requirement. Section 606 did not, however, eliminate the requirement that the responsible agency obtain a competitive factors report from the Attorney General of the United States; that requirement remains unchanged. In addition, section 606 also added the requirement that in processing a merger application, the FRB, the OCC, or the OTS, as the case may be, must submit a copy of each request for a competitive factors report to the FDIC.

Section 606 also made two changes to the Bank Merger Act that apply to mergers that solely involve an insured depository institution and one or more affiliates (“Affiliate Mergers”). First, for Affiliate Mergers, section 606 amended section 18(c)(4) of the FDI Act, 12 U.S.C. 1828(c)(4), to eliminate the need for the responsible Federal banking agency to request competitive factors reports from either the other Federal banking agencies or the Attorney General of the United States. Prior to FSRRA the responsible Federal banking agency had to request competitive factors reports for Affiliate Mergers. Second, section 606 revised section 18(c)(6) of the FDI Act, 12 U.S.C. 1828(c)(6), to eliminate the post-approval waiting period for Affiliate Mergers. Prior to FSRRA the applicant in an Affiliate Merger had to wait up to thirty days after obtaining the agency's approval before it could consummate the transaction.

Therefore, the FDIC is conforming its Statement of Policy to the Bank Merger Act, as amended by the FSRRA. Accordingly, the FDIC is hereby amending paragraphs 4 and 5 of Section II of the Statement of Policy to read as follows:

Proposed Project Feasibility of Secure Messaging for Pediatric Patients With Chronic Disease: Pilot Implementation in Pediatric Respiratory Medicine

AHRQ proposes to evaluate how the implementation of a secure email messaging (e-messaging) system between clinicians and adolescent patients affects: (1) Time spent by providers communicating with patients, (2) Emergency Department utilization for medication refills, and (3) qualitative satisfaction with care of the patients. The study will be conducted in the Yale University School of Medicine Pediatric Respiratory Medicine Clinic.

Several studies have evaluated the use of e-mail between providers and patients and found that it is typically satisfactory to both, has not been abused by patients, and has not been used inappropriately for urgent items. Studies have not evaluated the use of e-mailing or secure messaging by children or adolescents with chronic diseases as well as their families. The setting of chronic disease provides a natural forum for discussion about the use of such technologies since these families may need more frequent contact with their care-providers, need more frequent medication refills, and may have close relationships with their providers that encourage a communication genre such as secure messaging.

In particular, because many adolescents are comfortable with text messaging and email, the investigators hypothesize that adolescent patients themselves may feel empowered to contact their providers using this medium. This potential shift to having adolescents communicate with the providers presents two main hypotheses of interest. (1) Adolescents may be more prone to send a message that may be of an urgent nature because of the sense that messaging is“instant” as well as a possible feeling of more privacy. This issue presents the concern that adolescents in particular could send a secure message about information that is potentially urgent in nature such as a severe asthma exacerbation or suicidal ideation. Such messages will need immediate attention. (2) Adolescents may be more apt to disclose questions about their care that they would not have otherwise brought up with the provider. By giving adolescents a medium where they feel comfortable communicating, clinicians may be able to better meet the medical and psychosocial needs of adolescents and their families.

The project will include 300 patient/family participants and 138 provider participants. Data will be collected from (1) e-messaging content, to understand what children, adolescents and their parents will send in secure messages to their provider; (2) a survey, to determine the demographic characteristics of the patients and their family; and (3) qualitative interviews with patients and their families and clinic staff, to assess their attitudes and satisfaction with e-messaging.

Exhibit 1 shows the estimated annualized burden hours. Each of the 300 patient/family participants will complete a demographic survey and use the e-messaging system, sending an average of one e-message per month. Thirty of the patient/family participants will be randomly selected to participate in a qualitative interview. Each of the 138 provider participants will use the e-messaging system, responding to about twenty-six e-messages per year, and keep a pre- and post-intervention log of patient/provider communications. Ten provider participants will be randomly selected to participate in a qualitative interview. The total burden for all participants is estimated to be 2,148 hours.

Exhibit 2 shows the estimated annualized cost burden for the participants' time to participate in this study. The total cost burden for all participants is estimated to be $72,664.

Proposed Project Improving Quality Through Health IT: Testing the Feasibility and Assessing the Impact of Using Existing Health IT Infrastructure for Better Care Delivery

AHRQ proposes to assess how the use of health information technology (IT) can improve care delivery and outcomes in community health centers. AHRQ is specifically interested in improving the quality of care provided in a community clinic setting through better management of laboratory information. The study will measure the impact of health IT tools on two problems: duplicate laboratory tests and the failure to follow up on laboratory test results of HIV patients and women screened for cervical cancer. In addition, AHRQ will measure the impact of health IT on compliance with evidence-based guidelines for laboratory tests. The study will also investigate whether disparities between vulnerable populations and the general population exist in both laboratory screening rates and rates of abnormal laboratory test results without follow up. To assess the extent of these problems and the impact of health IT, AHRQ will evaluate both quantitative and qualitative components. The qualitative component will use interviews with key informants in two community health centers to gather data on laboratory information processes, laboratory information communication problems and use of health IT tools.

Quantitative data will be collected directly from the clinical data warehouse used by the participating community health centers to routinely collect laboratory data. The collection will be accomplished using database reports. Qualitative data will be collected through key informant interviews conducted in each of the two participating community health centers. Key informants will include physicians, nurses, medical assistants, IT personnel, and administrators. The total number of interviews to be conducted at both sites is forty-one.

Exhibit 1 shows the estimated annualized burden hours. A total of forty-one in-person interviews will be conducted with administration and clinical personnel: eighteen interviews from administrative personnel and twenty-three interviews from clinical personnel. The question set is the same for both clinical and administrative personnel. The estimated time per response is 1.5 hours for a total of 61.5 burden hours.

Exhibit 2 shows the estimated annualized burden for the respondents' time to provide the requested data. The hourly rate of $32.13 is a weighted average of the administrative personnel hourly wage of $19.68 and the clinical personnel hourly wage of $41.88. The total cost burden is $1,976.

The total cost to the Federal Government for this project is $393,457 over a two-year period. The average annual cost is $196,728. the following is a breakdown of average annual costs:

In accordance with the above-cited Paperwork Reduction Act legislation, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information necessary for the proper performance of AHRQ's health care research and health care information dissemination functions, including whether the information will have practical utility; (b) the accuracy of AHRQ's estimate of burden (including hours and costs) of the proposed collection(s) of information; (c) ways to enhance the quality, utility, and clarity of the information to be collected; and (d) ways to minimize the burden of the collection of information upon the respondents, including the use of automated collection techniques or other forms of information technology.

Comments submitted in response to this notice will be summarized and included in the Agency's subsequent request for OMB approval of the proposed information collection.

All comments will become a matter of public record.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Under sections 505, 512, 513, 515, and 903 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 355, 360b, 360c, 360e, and 393), and section 351 of the Public Health Service Act (42 U.S.C. 262), FDA has the responsibility to ensure the safety and effectiveness of drugs, biologics, and devices. Under section 502(a) of the act (21 U.S.C. 352(a)), a drug or device is misbranded if its labeling is false or misleading. Under section 502(f)(1) of the act it is misbranded if it fails to bear adequate warnings, and under section 502(j), it is misbranded if it is dangerous to health when used as directed in its labeling.

Under section 4 of the Dietary Supplement Health and Education Act of 1994 (Public Law 103-417), 21 U.S.C. 342 is amended so that FDA must bear the burden of proof to show a dietary supplement is unsafe.

To carry out its responsibilities, the agency needs to be informed whenever an adverse event, product problem, or error with use of a medication or device occurs. Only if FDA is provided with such information will the agency be able to evaluate the risk, if any, associated with the product, and take whatever action is necessary to reduce or eliminate the public's exposure to the risk through regulatory action. To ensure the marketing of safe and effective products, certain adverse events must be reported. Requirements regarding mandatory reporting of adverse events or product problems have been codified in parts 310, 314, 600, and 803 (21 CFR 310, 314, 600, and 803), specifically §§ 310.305, 314.80, 314.98, 600.80, 803.30, 803.50, 803.53, and 803.56.

Two forms are available from the agency in order to implement these provisions for reporting of adverse events, product problems, and medication/device use errors for FDA regulated products such as medications, devices, biologics, special nutritional products, cosmetics, dietary supplements, and non-prescription (OTC) human drug products marketed without an approved application, as well as any other products that are regulated by FDA. Form FDA 3500 may be used by health care professionals and the public for voluntary (i.e., not mandated by law or regulation) reporting. Form FDA 3500A is used by industry for mandatory reporting (i.e., required by law or regulation).

Respondents to this collection of information are health care professionals, hospitals and other user-facilities (e.g., nursing homes, etc.), consumers, manufacturers of biological and drug products or medical devices, and importers.

The voluntary version of the form is used to submit all reports not mandated by Federal law or regulation. Individual health professionals are not required by law or regulation to submit reports to the agency or the manufacturer, with the exception of certain adverse reactions following immunization with vaccines as mandated by the National Childhood Vaccine Injury Act of 1986 (Public Law 99-660). Those mandatory reports are not submitted to FDA on the 3500 or 3500A forms, but are submitted to the joint FDA/Centers for Disease Control and Prevention Vaccines Adverse Event Reporting System (VAERS) on the VAERS-1 form (see: http://www.vaers.hhs.gov/pdf/vaers_form.pdf ).

Hospitals are not required by Federal law or regulation to submit reports associated with drug products, biological products, or special nutritional products. However, hospitals and other user facilities are required by Federal law to report medical device-related deaths and serious injuries.

In sections 505(j) and 704 of the act (21 U.S.C. 374), Congress has required that important safety information relating to all human prescription drug products be made available to FDA so that it can take appropriate action to protect the public health when necessary. Section 702 of the act (21 U.S.C. 372) authorizes investigational powers to FDA for enforcement of the act. These statutory requirements regarding mandatory reporting have been codified by FDA under parts 310 and 314 (drugs) and 600 (biologics). Parts 310, 314, and 600 mandate the use of FDA Form 3500A for reporting to FDA on adverse events that occur with drugs and biologics.

Manufacturers whose name (under section 403(e)(1) of the act (21 U.S.C. 343(e)(1)) appears on the label of a dietary supplement marketed in the United States are required to report adverse reactions associated with use of the dietary supplement to FDA (the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law 109-462)).

Section 519 of the act (21 U.S.C. 360i) requires manufacturers and importers of devices intended for human use to establish and maintain records, make reports, and provide information as the Secretary of Health and Human Services may by regulation reasonably require to assure that such devices are not adulterated or misbranded and to otherwise assure their safety and effectiveness. The Safe Medical Device Act of 1990 (Public Law 91-4243), signed into law on November 28, 1990, amends section 519 of the act. The amendment requires that user facilities such as hospitals, nursing homes, ambulatory surgical facilities, and outpatient treatment facilities report deaths related to medical devices to FDA and to the manufacturer, if known. Serious illnesses and injuries are to be reported to the manufacturer or to FDA if the manufacturer is not known. These statutory requirements regarding mandatory reporting have been codified by FDA under part 803. Part 803 mandates the use of FDA Form 3500A for reporting to FDA on medical devices.

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA) (Public Law 107-250), signed into law October 26, 2002, amended section 519 of the act. The amendment (section 303 of MDUFMA) required FDA to revise the MedWatch forms “to facilitate the reporting of information * * *relating to reprocessed single-use devices, including the name of the reprocessor and whether the device has been reused.”

Under section 303 of the FDA Amendments Act of 2007 (Public Law 110-85), FDA must share reports for Humanitarian Device Exemption (HDE) devices. To facilitate sharing the appropriate reports, it would be helpful to obtain the HDE number in the present section G, box 5, on page 2 of FDA Form 3500A.

The proposed extension to Form FDA 3500 and Form FDA 3500A will only have changes in the form instructions to reflect the range of reportable products and provide clarity of reporting. The previous forms changes (2005-2008) allow reporters to better utilize available space for data entry and offer voluntary reporters the opportunity to clearly describe the suspected adverse event, product problem or error, and provide better quality safety-related data for agency evaluation.

FDA estimates the burden of this collection of information as follows:

Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only.

Under the PRA (44 U.S.C. 3501-3520), Federal agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques when appropriate, and other forms of information technology.

Under the Public Health Service Act (42 U.S.C. 262), FDA is required to ensure the marketing of only those biological products which are safe and effective. FDA must, therefore, be informed of all adverse experiences occasioned by the use of licensed biological products. FDA issued the AER requirements in part 600 (21 CFR part 600) to enable FDA to take actions necessary for the protection of the public health in response to reports of adverse experiences related to licensed biological products. The primary purpose of FDA's AER system is to flag potentially serious safety problems with licensed biological products, focusing especially on newly licensed products. Although premarket testing discloses a general safety profile of a biological product's comparatively common adverse effects, the larger and more diverse patient populations exposed to the licensed biological product provides the opportunity to collect information on rare, latent, and long-term effects. Reports are obtained from a variety of sources, including patients, physicians, foreign regulatory agencies, and clinical investigators. Information derived from the AER system contributes directly to increased public health protection because such information enables FDA to recommend important changes to the product's labeling (such as adding a new warning), to initiate removal of a biological product from the market when necessary, and to assure the manufacturer has taken adequate corrective action if necessary.

The regulation in § 600.80(c)(1) requires licensed manufacturers to report each adverse experience that is both serious and unexpected, whether foreign or domestic, as soon as possible but in no case later than 15 calendar days of initial receipt of the information by the licensed manufacturer. These are known as postmarketing 15-day Alert reports. Section 600.80(c)(1) also requires licensed manufacturers to submit any followup reports within 15 calendar days of receipt of new information or as requested by FDA. Section 600.80(e) requires licensed manufacturers to submit a 15-day Alert report for an adverse experience obtained from a postmarketing clinical study only if there is a reasonable possibility that the product caused the adverse experience. Section 600.80(c)(2) requires licensed manufacturers to report each adverse experience not reported in a postmarketing 15-day Alert report at quarterly intervals, for 3 years from the date of issuance of the biologics license, and then at annual intervals. The majority of these periodic reports will be submitted annually because a large percentage of currently licensed biological products have been licensed longer than 3 years. Section 600.80(i) requires licensed manufacturers to maintain for a period of 10 years records of all adverse experiences known to the licensed manufacturer, including raw data and any correspondence relating to the adverse experiences. Section 600.81 requires licensed manufacturers to submit, at an interval of every 6 months, information about the quantity of the product distributed under the biologics license, including the quantity distributed to distributors. These semiannual distribution reports provide FDA with important information about products distributed under biologics licenses, including the quantity, certain lot numbers, labeled date of expiration, number of dosage units, and date of release. Under § 600.90, a licensed manufacturer may submit a waiver request for any requirements that applies to the licensed manufacturer under § 600.80 and 600.81. A waiver request submitted under § 600.90 must include supporting documentation.

Manufacturers of biological products for human use must keep records of each step in the manufacture and distribution of a product including any recalls. These recordkeeping requirements serve preventative and remedial purposes by establishing accountability and traceability in the manufacture and distribution of products. These requirements also enable FDA to perform meaningful inspections.

Section 600.12 requires, among other things, concurrently with the performance of each step that all records of each step in the manufacture and distribution of a product be made and retained for no less than 5 years after the records of manufacture have been completed or 6 months after the latest expiration date for the individual product, whichever represents a later date. In addition, manufacturers must maintain records of sterilization of equipment and supplies, animal necropsy records, and records in cases of divided manufacturing of a product. Section 600.12(b)(2) requires manufacturers to maintain complete records pertaining to the recall from distribution of any product.

Respondents to this collection of information are manufacturers of biological products. Under table 1 of this document, the number of respondents is based on the estimated number of manufacturers that submitted the required information to the Center for Biologics Evaluation and Research and Center for Drug Evaluation and Research, FDA, in fiscal year (FY) 2006. Based on information obtained from FDA's database system, there were 88 licensed biologics manufacturers. This number excludes those manufacturers who produce blood and blood components and in-vitro diagnostic licensed products, because § 600.80(k) specifically exempts manufacturers of these products from adverse experience reporting requirements. The total annual responses are based on the estimated number of submissions received annually by FDA in FY 2006. However, not all manufacturers have submissions in a given year and some may have multiple submissions. There were an estimated 23,835 15-day Alert reports, 21,872 periodic reports, and 179 lot distribution reports submitted to FDA. The number of 15-day Alert reports for postmarketing studies under § 600.80(e) is included in the total number of 15-day Alert reports. FDA received 6 requests for waiver under § 600.90, all of which were granted. The hours per response are based on FDA experience. The burden hours required to complete the MedWatch Form for § 600.80(c)(1), (e), and (f) are reported under OMB control no. 0910-0291.

FDA estimates the burden of this collection of information as follows:

Under table 2 of this document, the number of respondents is based on the number of manufacturers subject to those regulations. Based on information obtained from FDA's database system, there were 303 licensed manufacturers of biological products in FY 2006. However, the number of recordkeepers listed for § 600.12(a) through (e) excluding (b)(2) is estimated to be 112. This number excludes manufacturers of blood and blood components because their burden hours for recordkeeping have been reported under 21 CFR 606.160 in OMB control no. 0910-0116. The total annual records is based on the annual average of lots released (5,291), number of recalls made (1,841), and total number of adverse experience reports received (45,707) in FY 2006. The hours per record are based on FDA experience.

FDA estimates the burden of this recordkeeping as follows:

This draft guidance document recommends studies that may be used to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) for the detection or detection and differentiation of influenza viruses. The document addresses devices that detect either influenza viral antigens or influenza viral genome (protein or nucleic acid), including those for novel influenza viruses in either human specimens or culture isolate. The guidance does not address devices that detect serological response from the host to the viral antigen, nor does it address establishing performance of non-influenza components of multi-analyte or multiplex devices. This guidance document identifies the classification regulations and product codes for existing legally marketed influenza tests and supplements other FDA documents that discuss the specific contents of premarket submissions.

This draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The draft guidance, when finalized will represent the agency's current thinking on establishing the performance characteristics of in vitro diagnostic devices for the detection or detection and differentiation of influenza viruses. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute and regulations.

Persons interested in obtaining a copy of the draft guidance may do so by using the Internet. To receive “Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection or Detection and Differentiation of Influenza Viruses,” you may either send an e-mail request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 240-276-3151 to receive a hard copy. Please use the document number 1638 to identify the guidance you are requesting.

CDRH maintains an entry on the Internet for easy access to information including text, graphics, and files that may be downloaded to a personal computer with Internet access. Updated on a regular basis, the CDRH home page includes device safety alerts, Federal Register reprints, information on premarket submissions (including lists of approved applications and manufacturers' addresses), small manufacturer's assistance, information on video conferencing and electronic submissions, Mammography Matters, and other device-oriented information. The CDRH Web site may be accessed at http://www.fda.gov/cdrh . A search capability for all CDRH guidance documents is available at http://www.fda.gov/cdrh/guidance.html . Guidance documents are also available on the Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets/default.htm .

This draft guidance refers to previously approved collections of information found in FDA regulations and guidance documents. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in 21 CFR part 807 subpart E have been approved under OMB Control No. 0910-0120; the collections of information in 21 CFR parts 50 and 56 have been approved under OMB Control No. 0910-0130; the collections of information in 21 CFR part 814 have been approved under OMB Control No. 0910-0231; the collections of information in 21 CFR part 812 have been approved under OMB Control No. 0910-0078; and the collections of information associated with CLIA waiver submissions and described in the draft guidance document for industry and FDA staff, “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications” have been approved under OMB Control No. 0910-0598.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ), written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only.

FDA is announcing the availability of a guidance for industry entitled “Safety Testing of Drug Metabolites.” This guidance addresses drug metabolites of small molecule nonbiologic drug products and does not apply to some cancer products. It applies to drug metabolites that are not adequately evaluated in standard toxicology testing with the parent drug. This can happen if the metabolite is present only in humans or if it is present at higher levels (referred to in the guidance as “disproportionate drug metabolite”) in humans than in any of the animal toxicology test species. The guidance provides recommendations on the timing and types of nonclinical safety studies that should be conducted for drug metabolites that are present at greater than 10 percent of the parent drug systemic exposure as measured in plasma.

A draft version of this guidance was made available for public comment in 2005 (70 FR 32839, June 6, 2005). All of the public comments we received have been considered and the guidance was revised as appropriate.

This guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115). The guidance represents the agency's current thinking on the safety testing of drug metabolites. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statutes and regulations.

Interested persons may submit to the Division of Dockets Management (see ADDRESSES ) written or electronic comments regarding this document. Submit a single copy of electronic comments or two paper copies of any mailed comments, except that individuals may submit one paper copy. Comments are to be identified with the docket number found in brackets in the heading of this document. Received comments may be seen in the Division of Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

Please note that on January 15, 2008, the FDA Web site transitioned to the Federal Dockets Management System (FDMS). FDMS is a Government-wide, electronic docket management system. Electronic submissions will be accepted by FDA through FDMS only.

Persons with access to the Internet may obtain the document at either http://www.fda.gov/cder/guidance/index.htm or http://www.fda.gov/ohrms/dockets/default.htm .

In the Federal Register of January 11, 2008, FDA announced that a meeting of the Anti-Infective Drugs Advisory Committee would be held on February 27 and 28, 2008. On page 2056, in the first column, the Date and Time and Agenda portions are amended to read as follows:

Date and Time : The meeting will be held on February 27, 2008, from 8 a.m. to 5 p.m.

Agenda : On February 27, 2008, the committee will discuss new drug application (NDA) 022-110, telavancin powder for reconstitution and intravenous administration, Theravance, Inc., proposed for the treatment of complicated skin and skin structure infection.

This notice is issued under the Federal Advisory Committee Act (U.S.C. app. 2) and 21 CFR part 14, relating to advisory committees.

The notice of a major disaster declaration for the State of Arkansas is hereby amended to include the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of February 7, 2008.

The National Advisory Council (NAC) is an advisory committee established in accordance with the provisions of the Federal Advisory Committee Act (FACA) 5 U.S.C. (Pub. L. 92-463). Section 508 of the Homeland Security Act of 2002 (Pub. L. 107-296), as amended by section 611 of the Post-Katrina Emergency Management Reform Act of 2006, as set forth in the Department of Homeland Security Appropriations Act of 2007 (Pub. L. 109-295), directed the Secretary of Homeland Security to establish the NAC to ensure effective and ongoing coordination of Federal preparedness, protection, response, recovery, and mitigation for natural disasters, acts of terrorism, and other man-made disasters.

The NAC assists FEMA in carrying out its missions by providing advice and recommendations in the development and revision of the national preparedness goal, the national preparedness system, NIMS, the National Response Plan, and other related plans and strategies. The members of the NAC are appointed by the Administrator of FEMA and are composed of Federal, State, local, tribal, and private-sector leaders and subject matter experts in law enforcement, fire, emergency medical services, hospital, public works, emergency management, State and local governments, public health, emergency response, standards-setting and accrediting organizations, representatives of individuals with disabilities and other special needs, infrastructure protection, cyber security, communications, and homeland security communities.

Some members are appointed as Special Government Employees (SGE) as defined in section 202(a) of title 18, United States Code. Specifically, the following four discipline areas will be filled by SGE appointments: Health scientist, infrastructure protection and communications. As a candidate for appointment as a SGE, applicants are required to complete a Confidential Financial Disclosure Report (OGE Form 450). OGE Form 450 or the information contained therein may not be released to the public except under an order issued by a Federal court or as otherwise provided under the Privacy Act (5 U.S.C. 552a). Applicants can obtain this form by going to the website of the Office of Government Ethics ( http://www.oge.gov ), or by contacting Alyson Price. Ms. Price's contact information is provided in FOR FURTHER INFORMATION CONTACT above.

Qualified individuals interested in serving on the NAC are invited to apply for appointment by submitting a resume or CV along with letters of recommendation to Ms. Price. Current NAC members whose terms are ending should notify the Designated Federal Officer of their interest in reappointment in lieu of submitting a new application, and should provide an updated resume or CV, and letters of recommendation for consideration.

The NAC meets in a plenary session approximately once per quarter. With respect to quarterly meetings, the NAC also holds at least one teleconference meeting with public call-in lines. Members serve without compensation from the Federal Government; however, consistent with the charter, they do receive travel reimbursement and per diem under applicable Federal travel regulations.

In support of the policy of the Department of Homeland Security on gender and ethic diversity, qualified women and minorities are encouraged to apply for membership.

Notice is hereby given that, in a letter dated February 6, 2008, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Kenneth R. Tingman, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.

The following areas of the State of Hawaii have been designated as adversely affected by this declared major disaster:

Notice is hereby given that, in a letter dated February 7, 2008, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, Department of Homeland Security, under Executive Order 12148, as amended, Philip E. Parr, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.

I do hereby determine the following areas of the State of Arkansas to have been affected adversely by this declared major disaster:

Notice is hereby given that, in a letter dated February 5, 2008, the President declared a major disaster under the authority of the Robert T. Stafford Disaster Relief and Emergency Assistance Act, 42 U.S.C. 5121-5206 (the Stafford Act), as follows:

The Federal Emergency Management Agency (FEMA) hereby gives notice that pursuant to the authority vested in the Administrator, under Executive Order 12148, as amended, Michael L. Parker, of FEMA is appointed to act as the Federal Coordinating Officer for this declared disaster.

The following areas of the State of Missouri have been designated as adversely affected by this declared major disaster:

The notice of a major disaster declaration for the State of Arkansas is hereby amended to include the Individual Assistance program in the following areas among those areas determined to have been adversely affected by the catastrophe declared a major disaster by the President in his declaration of February 7, 2008.