March 2006 – Federal Register Recent Federal Regulation Documents

NMFS issues this proposed rule to implement a regulatory amendment to the Fishery Management Plan for the Reef Fish Resources of the Gulf of Mexico (FMP) prepared by the Gulf of Mexico Fishery Management Council (Council). This proposed rule would establish a recreational bag limit for Gulf red grouper of one fish per person per day; prohibit the captain and crew of a vessel operating as a charter vessel or headboat from retaining any Gulf grouper, i.e.,establish a zero bag limit for captain and crew; and establish a seasonal closure of the recreational fishery for gag, red grouper, and black grouper in or from the Gulf exclusive economic zone (EEZ). The intended effect of this proposed rule is to maintain recreational landings at levels consistent with the red grouper rebuilding plan while minimizing potential shift of fishing effort to associated grouper species.

The Office of Citizen Exchanges of the Bureau of Educational and Cultural Affairs, United States Department of State, announces an open competition for grants to support programs promoting ``Africa Workforce Development'' through professional exchanges and collaboration. In carrying out a proposed program, roughly equal numbers of participants should travel between the U.S. and the focus African country. U.S. public and private non-profit organizations meeting the provisions described in Internal Revenue Code section 26 U.S.C. 501(c)(3) may submit proposals to develop and implement programs of exchange, collaboration and training that involve participants from Sub-Saharan Africa, including consultations, planning, and training conducted both in Sub-Saharan Africa and in the United States. These U.S. organizations should provide evidence of relevant expertise in Sub-Saharan Africa. Up to two grants not exceeding $200,000 each may be awarded.

Following receipt of a request on March 20, 2006, from United States Trade Representative (USTR) under authority delegated by the President and pursuant to section 103 of the North American Free Trade Agreement (NAFTA) Implementation Act (19 U.S.C. 3313), the Commission instituted investigation No. NAFTA-103-014, Probable Effect of Certain Modifications to the North American Free Trade Agreement Rules of Origin. Background: According to the USTR's letter, U.S. negotiators have recently reached agreement in principle with representatives of the governments of Canada and Mexico on proposed modifications to Annexes 401 and 403 of the NAFTA. Chapter 4 and Annexes 401 and 403 of the NAFTA set forth in the rules of origin for applying the tariff provisions of the NAFTA to trade in goods. Section 202(q) of the NAFTA Implementation Act (the Act) authorizes the President, subject to the consultation and layover requirements of section 103 of the Act, to proclaim such modifications to the rules as may from time to time be agreed to by the NAFTA countries. One of the requirements set out in section 103 of the Act is that the President obtain advice from the United States International Trade Commission. The USTR has requested that the Commission provide advice on the probable effect on U.S. trade under the NAFTA and on domestic industries as a result of proposed modifications to the rules of origin in NAFTA Annexes 401 and 403 for a number of products. A complete listing of the products and the proposed modifications is available from the Office of the Secretary to the Commission or by accessing the electronic version of this notice at the Commission's Internet site (https://www.usitc.gov). The current U.S. rules of origin can be found in General Note 12 of the 2005 Harmonized Tariff Schedule of the United States (see ``General Notes'' link at https://hotdocs.usitc.gov/tariff chapterscurrent/toc.html). As requested, the Commission will forward its advice to the USTR by August 14, 2006.

The United States International Trade Commission hereby provides notice of an update to the Commission's Electronic Document Information System (EDIS). The update to EDIS includes an enhanced interface for the filing of electronic documents and a revised Handbook on Electronic Filing Procedures.

Notice is hereby given that South Carolina Department of Natural Resources (SCDNR), Marine Resources Division, P.O. Box 12559, Charleston, S.C. 29422-2559, has requested a modification to scientific research Permit No. 1540.

EPA does not object to the proposed action. Rating LO.

Pursuant to FAA's rulemaking provisions governing the application, processing, and disposition of petitions for exemption part 11 of Title 14, Code of Federal Regulations (14 CFR), this notice contains a summary of certain petitions seeking relief from specified requirements of 14 CFR. The purpose of this notice is to improve the public's awareness of, and participation in, this aspect of FAA's regulatory activities. Neither publication of this notice nor the inclusion or omission of information in the summary is intended to affect the legal status of any petition or its final disposition.

This notice announces the Secretary of Commerce's approval of Federal Information Processing Standard (FIPS) Publication 201-1, Standard for Personal Identity Verification of Federal Employees and Contractors. The changes to Section 2.2, PIV Identify Proofing and Registration Requirements, Section 4.3, Cryptographic Specifications, Section 5.2, PIV Identity Proofing and Registration Requirements, and to Section 5.3.1, PIV Card Issuance, clarify the identity proofing and registration process that departments and agencies should follow when issuing identity credentials. These changes are needed to make FIPS 201-1 consistent with the Memorandum for All Departments and Agencies (M-05-24), issued by the Office of Management and Budget on August 5, 2005, Implementation of Homeland Security Presidential Directive (HSPD) 12Policy for a Common Identification Standard for Federal Employees and Contractors.

This notice announces the Secretary of Commerce's approval of Federal Information Processing Standard (FIPS) 200, Minimum Security Requirements for Federal Information and Information Systems. The use of FIPS 200 is compulsory and binding on federal agencies for: (i) All information within the federal government other than that information that has been determined pursuant to Executive Order 12958, as amended by Executive Order 13292, or any predecessor order, or by the Atomic Energy Act of 1954, as amended, to require protection against unauthorized disclosure and is marked to indicate its classified status; and (ii) all federal information systems other than those information systems designated as national security systems as defined in 44 United States Code Section 3542(b)(2). FIPS 200 was developed to complement similar standards for national security systems.

In compliance with the Paperwork Reduction Act of 1995 (44 U.S.C. 3501 et seq.), this notice announces that the Information Collection Request (ICR) abstracted below has been forwarded to the Office of Management and Budget (OMB) for review and comment. The ICR describes the nature of the information collections and their expected burden. The Federal Register Notice with a 60-day comment period was published on January 10, 2006 (71 FR 1583).

Pursuant to the National Environmental Policy Act (NEPA) of 1969, as amended, and the Council on Environmental Quality's Regulations for Implementing the Procedural Provisions of NEPA, the Department of the Interior (Department) has issued a Scoping Summary Report on the development of Lower Basin shortage guidelines and coordinated management strategies for the operation of Lake Powell and Lake Mead, particularly under low reservoir conditions. The Scoping Summary Report provides a summary of the issues raised during the scoping process and describes the Department's current assessment of the proposed scope of the environmental analysis to be included in the draft environmental impact statement (EIS). The Department anticipates that the Draft EIS will be published in December 2006. The report also includes a summary of the issues raised and comments received during the scoping process. Among other things, the report identifies how the Department anticipates addressing these issues. Dates and Addresses: The Department will accept, review, and incorporate, as appropriate, any additional public comments on the information contained in the Scoping Summary Report as part of the development of the Draft EIS, which the Department anticipates will be published in December 2006. The Department would prefer that any such comments be received by May 1, 2006, in order to allow full consideration during the development of the Draft EIS. Send written comments to: Regional Director, Bureau of Reclamation, Lower Colorado Region, Attention: BCOO-1000, P.O. Box 61470, Boulder City, Nevada 89006-1470; faxogram at (702) 293-8156; or e-mail at strategies@lc.usbr.gov. The Scoping Summary Report is available on the Bureau of Reclamation's Web site at https://www.usbr.gov/lc/region/g4000/ strategies/. If you would like a printed copy of the report, please contact Nan Yoder at telephone (702) 293-8500; facsimile (702) 293-8156; e-mail: strategies@lc.usbr.gov.

This notice advises the public that the Department of Energy (``DOE'') and Department of the Interior (``DOI'') (collectively referred to as the ``Departments'') intend to jointly hold a three-day public scoping meeting in connection with the Department's ongoing study of energy rights-of-way on tribal land pursuant to section 1813 of the Energy Policy Act of 2005. Through these meetings, the Departments invite the public to provide additional oral or written comments about how to proceed with the implementation of section 1813.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Providing Regulatory Submissions in Electronic FormatOrphan-Drug and Humanitarian Use Device Designation Requests and Related Submissions.'' This is one in a series of guidance documents on providing regulatory submissions to FDA in electronic format. This guidance discusses issues related to the electronic submission of orphan-drug and humanitarian use device (HUD) designation requests and related submissions to the Office of Orphan Products Development (OPD). The submission of these documents in electronic format should improve the agency's efficiency in processing, archiving, and reviewing them.

Pursuant to Section 102(2)(C) of the National Environmental Policy Act of 1969, as amended, notice is hereby given that the Bureau of Land Management (BLM), Nevada State Office and Ely Field Office, will be initiating the preparation of an environmental impact statement (EIS) and conducting public scoping meetings to analyze the proposed Kane Springs Valley (KSV) Groundwater Development Project, which will include production wells, a water transmission pipeline with lateral pipelines, electric lines, and communication lines. The purpose of the project is to develop and convey water from Kane Springs Valley to private land in the Coyote Springs Valley.

In accordance with the Paperwork Reduction Act of 1995 (Pub. L. 104-13) and Office of Management and Budget (OMB) regulations at 5 CFR part 1320 (60 FR 44978, August 29, 1995), this notice announces the National Agricultural Library's intent to request renewal of an approved electronic mailing list subscription form from those who work in the nutrition and food safety fields.

The Bureau of Immigration and Customs Enforcement in the Department of Homeland Security is creating a new system of records to be used in the management of case and document information by attorneys working for the Office of the Principal Legal Advisor in the preparation and presentation of cases for a court or adjudicative body before which the Bureau of Immigration and Customs Enforcement or the Department of Homeland Security is authorized or required to appear.

The NRC is preparing a submittal to OMB for review of continued approval of information collections under the provisions of the Paperwork Reduction Act of 1995 (44 U.S.C. Chapter 35). Information pertaining to the requirement to be submitted: 1. The title of the information collection: 10 CFR part 60 ``Disposal of High-Level Radioactive Wastes in Geologic Repositories''. 2. Current OMB approval number: 3150-0127. 3. How often the collection is required: The information need only be submitted one time. 4. Who is required or asked to report: State or Indian Tribes, or their representatives, requesting consultation with the NRC staff regarding review of a potential high-level radioactive waste geologic repository site, or wishing to participate in a license application review for a potential geologic repository (other than a potential geologic repository site at Yucca Mountain, Nevada, currently under investigation by the U.S. Department of Energy, which is now regulated under 10 CFR part 63). 5. The number of annual respondents: 1; however none are expected in the next three years. 6. The number of hours needed annually to complete the requirement or request: 1; however, none are expected in the next three years. 7. Abstract: Part 60 requires States and Indian Tribes to submit certain information to the NRC if they request consultation with the NRC staff concerning the review of a potential repository site, or wish to participate in a license application review for a potential repository (other than the Yucca Mountain, Nevada site proposed by the U.S. Department of Energy). Representatives of States or Indian Tribes must submit a statement of their authority to act in such a representative capacity. The information submitted by the States and Indian Tribes is used by the Director of the Office of Nuclear Material Safety and Safeguards as a basis for decisions about the commitment of NRC staff resources to the consultation and participation efforts. As provided in Sec. 60.1, the regulations in 10 CFR. Part 60 no longer apply to the licensing of a geologic repository at Yucca Mountain. All of the information collection requirements pertaining to Yucca Mountain were included in 10 CFR part 63, and were approved by the Office of Management and Budget under control number 3150-0199. The Yucca Mountain site is regulated under 10 CFR part 63 (66 FR 55792, November 2, 2001). Submit, by May 30, 2006, comments that address the following questions: 1. Is the proposed collection of information necessary for the NRC to properly perform its functions? Does the information have practical utility? 2. Is the burden estimate accurate? 3. Is there a way to enhance the quality, utility, and clarity of the information to be collected? 4. How can the burden of the information collection be minimized, including the use of automated collection techniques or other forms of information technology? A copy of the draft supporting statement may be viewed free of charge at the NRC Public Document Room, One White Flint North, 11555 Rockville Pike, Room O-1 F21, Rockville, MD 20852. OMB clearance requests are available at the NRC worldwide Web site: https:// www.nrc.gov/public-involve/doc-comment/omb/. The document will be available on the NRC home page site for 60 days after the signature date of this notice. Comments and questions about the information collection requirements may be directed to the NRC Clearance Officer, Brenda Jo. Shelton, U.S. Nuclear Regulatory Commission, T-5 F53, Washington, DC 20555-0001, by telephone at 301-415-7233, or by Internet electronic mail to INFOCOLLECTS@NRC.GOV.

The Food and Drug Administration (FDA) is announcing a publication containing modifications the agency is making to the list of standards FDA recognizes for use in premarket reviews (FDA recognized consensus standards). This publication, entitled ``Modifications to the List of Recognized Standards, Recognition List Number: 014'' (Recognition List Number: 014), will assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices.

The Committee is proposing to delete a product and services previously furnished by nonprofit agencies employing persons who are blind or have other severe disabilities. Comments Must be Received on or Before: April 30, 2006.

The Health Resources and Services Administration (HRSA) announces the cancellation of the following grant opportunities that were initially published on Grants.gov Find, in the HRSA Preview, and on the HRSA Web site (https://www.hrsa.gov/grants/preview/).

Notice is hereby given that on February 28, 2006, the Department of Health and Human Services (HHS) Debarring Official, on behalf of the Secretary of HHS, issued a final notice of debarment based on the scientific misconduct findings of the U.S. Public Health Service (PHS) in the following case: Susan M. Aronica, PhD, Indiana University Purdue University Indianapolis: Based on the evidence and findings of an investigation report by Indiana University Purdue University Indianapolis (IUPUI) and additional analysis conducted by the Office of Research Integrity (ORI) in its oversight review, ORI found that Susan M. Aronica, Ph.D., former Postdoctoral Student/Fellow, IUPUI, committed 21 acts of scientific misconduct by knowingly and intentionally falsifying and fabricating data in her notebooks, in 17 figures and figure panels, in two tables published in the Journal of Biological Chemistry (J. Biol. Chem. 270:21998-22007, 1995) and Blood (Blood 89:3582-3595, 1997), and in two figures in a manuscript submitted for publication to Blood in August 1997. ORI issued a charge letter enumerating the above findings of scientific misconduct. However, Dr. Aronica requested a hearing to dispute these findings to the Departmental Appeals Board. Based upon the insufficiency of Dr. Aronica's hearing request, ORI filed a Motion to Dismiss. On February 10, 2006, the Administrative Law Judge (ALJ) ruled in ORI's favor by dismissing Dr. Aronica's request for a hearing. ORI's research misconduct regulation specifically delineates the requisite content for an acceptable hearing request. A sustainable hearing request must admit or deny each finding of research misconduct, and each denial must be detailed and substantive. 42 CFR 93.501(c). Dr. Aronica's hearing request contained only a general denial of the proposed findings. The regulation states that a general denial is not sufficient to establish a genuine dispute. 42 CFR 93.503. The regulation also states that the ALJ must dismiss a hearing request if the respondent does not raise a genuine dispute over facts or law material to the research misconduct findings. 42 CFR 93.504(a)(2). The ALJ concluded that the determination of whether the hearing request raises a genuine dispute is a threshold jurisdictional determination. Thus, the ALJ decided that Dr. Aronica's request did not show a genuine dispute, because it did not specifically deny any allegation. As a result, the ALJ concluded that Dr. Aronica's hearing request could not be granted, but was required to be dismissed pursuant to 42 CFR 93.504(a)(2). Specifically, ORI found that Dr. Aronica falsified and fabricated data in: Figures 1, 2, 3, 4, 5A, 5B, 5C, 6A, and 6B, and Tables III and IV in: Aronica, S.M., Mantel, C., Gonin, R., Marshall, M.S., Sarris, A., Cooper, S., Hague, N., Zhang, X., & Broxmeyer, H.E. ``Interferon-inducible Protein 10 and Macrophage Inflammatory Protein-1 [alpha] Inhibit Growth Factor Stimulation of Raf-1 Kinase Activity and Protein Synthesis in a Human Growth Factor-dependent Hematopoietic Cell Line.'' JBC 270:21998-22007, 1995 (September 15) (``JBC paper''). Figures 1 (both panels), 3A, 3B, 3D, 3E, 4A, and 8A in: Aronica, S.M., Gingras, A.C., Sonenberg, N., Cooper, S., Hague, N., & Broxmeyer, H.E. ``Macrophage Inflammatory Protein-1 [alpha] and Interferon-inducible Protein 10 Inhibit Synergistically Induced Growth Factor Stimulation of MAP Kinase Activity and Suppress Phosphorylation of Eukaryotic Initiation Factor 4E and 4E Binding Protein 1.'' Blood 89:3582-3595, 1997 (May 15) (``Blood paper''). Figures 1B and 2B in: Aronica, S.M., Reid, S.L., & Broxmeyer, H.E. ``Chemokine Inhibition of Stress-Activated Kinase Activity in a Human Hematopoietic Cell Line.'' Blood, submitted August 4, 1997 (``Blood manuscript''). The research was supported by or reported in the following U.S. Public Health Service (PHS) grants from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Heart, Lung, and Blood Institute (NHLBI) of the National Institutes of Health: RO1 HL49202, ``Myeloid Regulation by Growth-Suppressing Cytokines.'' R01 HL54037, ``Stem Cell Transduction of SLF/FLT-3-Ligand Genes by AAV.'' R01 HL56416, ``Mechanisms of Synergistic Regulation of Stem/Progenitors.'' T32 DK07519, ``Regulation of Hematopoietic Cell Production.'' The following administrative actions have been implemented: (1) Dr. Aronica has been debarred from any contracting or subcontracting with any agency of the United States Government and from eligibility or involvement in nonprocurement programs of the United States Government referred to as ``covered transactions'' as defined in the debarment regulations at 45 CFR part 76 for a period of five (5) years, beginning on February 10, 2006; (2) Dr. Aronica is prohibited from serving in any advisory capacity to PHS including but not limited to service on any PHS advisory committee, board, and/or peer review committee, or as consultant for a period of five (5) years, beginning on February 10, 2006; and (3) Within 60 days of February 10, 2006, the authors of the following papers will be requested to submit a letter to the editors of Journal of Biological Chemistry and Blood, requesting their retraction of: Aronica, S.M., Mantel, C., Gonin, R., Marshall, M., Sarris, A., Cooper, S., Hague, N., Zhang, X-f., & Broxmeyer, H.E. ``Interferon-Inducible Protein 10 and Macrophage Inflammatory Protein-1 [alpha] inhibit Growth Factor Stimulation of Raf-1 Kinase Activity and Protein Synthesis in a Human Growth Factor-Dependent Hematopoietic Cell Line.'' J. Biol. Chem. 270:21998-22007, 1995. Aronica, S.M., Gingras, A.-C., Sonenberg, N., Cooper, S., Hague, N., and Broxmeyer, H.E. ``Macrophage Inflammatory Protein-1 [alpha] and Interferon-Inducible Protein 10 Inhibit Synergistically Induced Growth Factor Stimulation of MAP Kinase Activity and Suppress Phosphorylation of Eukaryotic Initiation Factor 4E and 4 Binding Protein 1.'' Blood 89:3582-3595, 1997.