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Commodity Credit Corporation and Farm Service Agency, USDA.
Interim rule; correction.
The Commodity Credit Corporation (CCC) is amending the Biomass Crop Assistance Program (BCAP) regulation to provide specifically for prioritizing limited program funds in favor of the “project area” portion of BCAP. CCC is also correcting errors in the regulation.
We invite you to submit comments on this interim rule. In your comment, include the Regulation Identifier Number (RIN) and the volume, date, and page number of this issue of the
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All written comments will be available for public inspection at the above address during business hours from 8 a.m. to 5 p.m., Monday through Friday, except holidays.
Kelly Novak,
CCC published a final rule on October 27, 2010 (75 FR 66202-66243) implementing BCAP as authorized by the Food, Conservation, and Energy Act of 2008 (the 2008 Farm Bill, Pub. L. 110-246). Section 9001 of the 2008 Farm Bill authorized such sums as necessary for BCAP. The Supplemental Appropriations Act, 2010 (Pub. L. 111-212) enacted on July 29, 2010, limited BCAP funding to $552 million in fiscal year 2010 and $432 million in fiscal year 2011. The Department of Defense and Full-Year Continuing Appropriations Act, 2011 (Pub. L. 112-10, referred to as the 2011 Appropriations Act) enacted on April 15, 2011, reduced further the total amount of money available for BCAP in FY 2011 to $112 million.
BCAP has two parts—one is for `project areas' to support the establishment of new sources of bioenergy. CCC provides establishment and annual payments to agricultural and forest land owners for the production of new crops for bioenergy and bio-based products. The other part of BCAP is for matching payments for the collection, harvest, storage and transportation (CHST) of existing sources of biomass. The limited funding available for BCAP means that not all BCAP requests can be funded. This interim rule explicitly provides a priority for funding establishment and annual payments for project area activities because such activities will produce the greatest long term good in BCAP by providing an on-going supply of new biomass. CHST would only be funded if resources are available after funding all eligible project area applications. The rule also enables prioritization among project area proposals if eligible requests exceed available funding. Future funding for BCAP could make such prioritizing unnecessary.
Under prioritization, FSA will issue a notice inviting project area proposals by a specified deadline. Applicants will be given at least 30 days to prepare their proposals. After the application period closes, FSA will review all proposals as a batch against a set of selection criteria, including, but not limited to, the following criteria as specified in 7 CFR 1450.202(a):
(1) The dry tons of the eligible crops proposed to be produced in the proposed project area and the probability that such crops will be used for BCAP purposes;
(2) The dry tons of renewable biomass projected to be available from sources other than the eligible crops grown on contract acres;
(3) The anticipated economic impact in the proposed project area;
(4) The opportunity for producers and local investors to participate in the ownership of the biomass conversion facility in the proposed project area;
(5) The participation rate by beginning or socially disadvantaged farmers or ranchers;
(6) The impact on soil, water, and related resources;
(7) The variety in biomass production approaches within a project area, including agronomic conditions, harvest and postharvest practices, and monoculture and polyculture crop mixes; and
(8) The range of eligible crops among project areas.
This interim rule also makes technical changes to the existing regulations to clarify a provision dealing with the eligibility of woody materials from forest lands, and corrects the use of the word “chapter” instead of “title,” and the word “applies” instead of “apply.” The clarification of the woody material eligibility provision is needed because as inadvertently written in the previous final rule, any herbaceous biomass (such as switchgrass) would not qualify for a matching payment unless it was removed to reduce forest fire, disease or insect infestation, or restore forest ecosystem health—conditions that are intended for woody biomass outside of BCAP project areas. The clarifying change would not affect woody biomass eligibility; rather it ensures that all herbaceous biomass (not just crop residues) qualifies for matching payments.
In addition, during our review of the final rule, we discovered a few inconsistencies between the text in the
Because this rule addresses an immediate need produced by a change in the funding level for BCAP and otherwise makes technical changes, it has been determined that it would be contrary to the public interest to delay the effective date of this rule. Therefore, prior comment and a delay in the effective date of this rule are not required by the Administrative Procedures Act (5 U.S.C. 553), the Small Business Regulatory Enforcement Fairness Act of 1996 (Pub. L. 104-121), or by the memorandum of the Secretary of Agriculture published in the
The Office of Management and Budget (OMB) designated this rule as significant under Executive Order 12866, “Regulatory Planning and Review,” and has reviewed this rule. A summary of the cost benefit analysis is provided below and is available from the contact information listed above.
This interim rule will allow CCC to prioritize available funds for the establishment of BCAP crops to maximize the benefits of BCAP. For FY2011, $196 million was initially made available to CCC, reflecting the estimate in the cost-benefit analysis accompanying the BCAP final rule and the authority in the 2008 Farm Bill for “such sums as are necessary” from CCC to operate the program. The 2011 Appropriations Act provides a final level of funding for BCAP in FY 2011 of $112 million, a reduction of $84 million from the previously available amount. In 2011, CCC received over 40 project area proposals well exceeding $160 million in funding need, therefore exceeding available funding. Given the limits in appropriated funds and the prioritization provisions of this interim rule, the cost of BCAP is therefore estimated to be $112 million in 2011. In FY 2011, $83.2 million of the total annual cost is estimated to be establishment and annual payments for project areas including technical assistance, with the remaining costs comprising CHST payments and a 1 percent reserve.
It has been determined that the Regulatory Flexibility Act is not applicable to this interim rule because CCC is not required by 5 U.S.C. 553 or any other provision of law to publish a notice of proposed rulemaking for this rule. As noted above in the Notice and Comment section, CCC is using the good cause justification of the Administrative Procedures Act to issue an interim rule effective on publication with an opportunity for comment.
The environmental impacts of this rule have been considered in a manner consistent with the provisions of the National Environmental Policy Act (NEPA, 42 U.S.C. 4321-4347), the regulations of the Council on Environmental Quality (40 CFR parts 1500-1508), and FSA regulations for compliance with NEPA (7 CFR part 799). The technical corrections identified in this interim rule do not change the structure or goals of BCAP and can be considered simply administrative in nature. Therefore, CCC has determined that NEPA does not apply to this interim rule and no environmental assessment or environmental impact statement will be prepared.
Executive Order 12372, “Intergovernmental Review of Federal Programs,” requires consultation with State and local officials. The objectives of the Executive Order are to foster an intergovernmental partnership and a strengthened Federalism, by relying on State and local processes for State and local government coordination and review of proposed Federal Financial assistance and direct Federal development. This rule neither provides Federal financial assistance or direct Federal development; it does not provide either grants or cooperative agreements. Therefore, this program is not subject to Executive Order 12372.
This rule has been reviewed under Executive Order 12988, “Civil Justice Reform.” The provisions of this rule will not have preemptive effect with respect to any State or local laws, regulations, or policies that conflict with such provision or which otherwise impede their full implementation. The rule will not have retroactive effect. Before any judicial action may be brought regarding this rule, all administrative remedies must be exhausted.
This rule has been reviewed under Executive Order 13132, “Federalism.” The policies contained in this rule will not have any substantial direct effect on States, the relationship between the Federal Government and the States, or the distribution of power and responsibilities among the various levels of government. Nor would this rule impose substantial direct compliance costs on State and local governments. Therefore, consultation with the States is not required.
This rule has been reviewed for compliance with Executive Order 13175, “Consultation and Coordination with Indian Tribal Governments.” The policies contained in this rule do not have tribal implications that preempt tribal law.
Title II of the Unfunded Mandate Reform Act of 1995 (UMRA, Pub. L. 104-4) requires Federal agencies to assess the effects of their regulatory actions on State, local, or tribal governments or the private sector. Agencies generally must prepare a written statement, including a cost benefit analysis, for proposed and final rules with Federal mandates that may result in expenditures of $100 million or more in any 1 year for State, local, or tribal governments, in the aggregate, or to the private sector. UMRA generally requires agencies to consider alternatives and adopt the more cost effective or least burdensome alternative that achieves the objectives of the rule. This rule contains no Federal mandates under the regulatory provisions of Title II of the Unfunded Mandates Reform Act of 1995 (UMRA, Pub. L. 104-4) for State, local, or tribal governments, or the private sector. In addition, CCC is not required to publish a notice of proposed rulemaking for this rule. Therefore, this interim rule is not subject to the requirements of sections 202 and 205 of UMRA.
This rule has not been determined to be major under SBREFA (Pub. L. 104-121). SBREFA normally requires that an agency delay the effective date of a major rule for 60 days from the date of publication to allow for Congressional review. Section 808 of SBREFA allows an agency to make a major regulation effective immediately if the agency
The information collection required for this rule has been approved by OMB under OMB control number 0560-0082.
CCC is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government Information and services, and for other purposes.
Administrative practice and procedure, Agriculture, Energy, Environmental protection, Grant programs—agriculture, Natural resources, Reporting and recordkeeping requirements, Technical assistance.
For the reasons discussed above, this rule corrects and amends 7 CFR part 1450 as follows:
7 U.S.C. 8111.
(f) Subject to the availability of funds and all other eligibility provisions of this part, this part provides the terms, conditions and requirements of BCAP. In the event that CCC determines that available funds are insufficient to accommodate the demand for establishment and annual payments as well as all potential applications for matching payments for collection, harvest, storage, and transportation of eligible material, without any advance notice other than that stated here, CCC may prioritize the expenditure of program funds in favor of funding for the selection of BCAP project areas and the establishment and annual payments related to those project areas, and may make such other priorities in approvals that will, in the determination of the Deputy Administrator, advance the purposes of BCAP.
Nuclear Regulatory Commission.
Final rule.
The U.S. Nuclear Regulatory Commission (NRC or the Commission) is amending its regulations by revising the provisions applicable to the licensing and approval processes for byproduct, source and special nuclear materials licenses, and irradiators. The changes will clarify the definitions of “construction” and “commencement of construction” with respect to materials licensing actions conducted under the NRC's regulations. The NRC is adopting these changes to further improve the effectiveness and efficiency of the licensing and approval processes for future materials license applications, as well as to eliminate certain inconsistencies that currently exist within the NRC's regulations with respect to the use and definition of the terms “construction” or “commencement of construction” for certain materials licensees for purposes of its environmental reviews.
This final rule is effective on November 14, 2011.
You can access publicly available documents related to this document using the following methods:
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Ms. Tracey Stokes, Office of the General Counsel, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001; telephone: 301-415-1064; e-mail:
On July 27, 2010 (75 FR 43865), the NRC published a proposed rule, “Licenses, Certifications, and Approvals for Materials Licenses.” The rule proposed to amend the NRC's regulations to clarify the definitions of “construction” and “commencement of construction” applicable to the licensing and approval processes for byproduct, source and special nuclear materials licenses, and irradiators. The
The inconsistencies that exist arose after the NRC modified the definition of “construction” applicable to nuclear power reactors and to the NRC environmental review regulations, but did not make comparable changes to its materials licensing regulations. On October 9, 2007 (72 FR 57416; corrected at 73 FR 22786 (April 28, 2008)), the NRC had amended the definition of “construction” for utilization and production facilities and amended the limited work authorization (LWA) procedures for nuclear power plants (LWA Rulemaking). As part of that rulemaking, the Commission revised the scope of activities that are considered construction and for which a construction permit, combined license, or LWA is necessary; specified the scope of construction activities that may be performed under an LWA; changed the review and approval process for LWA requests; and clarified the environmental review process for these activities.
Since the completion of the LWA Rulemaking, activities that do not constitute construction under Title 10 of the
The proposed rule was published on July 27, 2010 (75 FR 43865), with a 60-day comment period, which ended on September 27, 2010. The comment period was subsequently reopened and extended to November 29, 2010 (75 FR 60341; September 30, 2010). The NRC received 12 public comments on the proposed rule. The commenters include four members of the public, three industry organizations, two public interest and consumer advocacy groups,
Two of the comments received generally supported the NRC's decision to issue the proposed rule. Three of the comments, while critical of the proposed rule or its applicability to certain materials licenses at all, provided specific comment with respect to the proposed language. Seven of the comments received were opposed to the proposed rule, stating as their main objection their belief that the proposed rule is contrary to, and would negatively impact the NRC's implementation of the National Environmental Policy Act of 1969, as amended (NEPA), and other Federal environmental or conservancy statutes such as, the Bald Eagle Protection Act of 1940, the Endangered Species Act of 1973, the Fish and Wildlife Coordination Act of 1934, the Migratory Bird Conservation Act, and the National Historic Preservation Act of 1966, as amended.
The proposed rule also solicited comments on the utility of an LWA process specific to materials licenses. Four of the twelve commenters addressed this issue, and of the four, one was opposed, claiming that such a process would violate NEPA, and the remaining three indicated that there was some merit in the endeavor, and provided comments on the potential designs of such a process.
The NRC has carefully considered the public comments received. The comments have been organized by topic (
The NRC, through this rulemaking, is not authorizing any individual to engage in specific site preparation activities. Rather, the NRC is identifying those specific activities that are not subject to its regulatory authority. The private site preparation activities that occur, while not subject to NRC authority, in all likelihood are subject to regulatory authority of another Federal, State or local agency, through either a permitting or licensing process. Such Federal, State or local authority with permitting or licensing jurisdiction over private site preparation activities would be the proper entity to consider concerns pertaining to the activities, including the potential triggering of NEPA or State environmental review requirements as appropriate. The NRC would consider any request from another Federal, State or local agency with authority over the private action for the NRC to be a cooperating agency on a case-by-case basis within the scope of the NRC's jurisdictional authority and any applicable Memorandum of Understanding.
Four commenters provided comments in response to the NRC's question regarding whether an LWA process is appropriate. One commenter opposed such a process, claiming that an LWA process for materials licenses would result in segmentation of the major Federal action and would violate NEPA. The remaining three commenters were supportive of an LWA process.
One commenter states that an LWA process would permit only limited construction activities and the environmental impacts associated with activities would be evaluated in an Environmental Impact Statement (EIS) before the LWAs would be issued. However, that commenter also suggests that the NRC lacks the statutory authority to restrict the construction activities of some materials licensees, although the commenter did not identify which materials licensees were affected. This commenter offered suggested changes to the proposed rule. As an initial matter, the commenter suggests that the NRC revise the proposed rule to eliminate the concept of “commencement of construction.” This particular proposal is based, in part, on the commenter's belief that the NRC lacks the statutory authority necessary to prohibit a materials license applicant from engaging in construction. As is discussed further in Section III, Discussion, the NRC disagrees with this proposition. The Atomic Energy Act of 1954, as amended (AEA), confers on the NRC the authority to establish by rule and regulation such standards as the NRC “deems necessary or desirable” to ensure the public health and safety from radiological hazards, including limitations on an applicant's or licensee's ability to engage in construction.
The remaining two commenters address an LWA-like process that would be applicable primarily to
With respect to the proposed rule, the commenters stated that the proposed rule is too narrowly interpreted to meet the needs of ISR licensees. The commenters propose that the list of items that are not construction be modified to include: Wellfields (injection, production/extraction, and monitor well networks); administrative and other buildings and site roads and infrastructure intended to handle or process AEA material; and the central processing plant. The NRC is not adopting the commenters' proposal. Most of the listed construction activities when complete would be utilized to handle, use, process, or store radioactive material; therefore, such activities would be viewed as having a reasonable nexus to radiological health and safety or common defense and security, and hence would be considered construction. The only exception would be with respect to administrative and other buildings, and site roads and infrastructure. The commenter indicates that this category of actions would include not only construction of buildings that would eventually be used to handle AEA materials, but also construction of buildings and facilities that are not specific to the NRC license or radioactive materials. This latter
With respect to their proposed LWA-like process, these commenters also suggest a three-tier process that permits certain pre-licensing construction activities. Tier 1 would identify those construction activities that could occur prior to licensing without staff approval. Tier 2 would identify those construction activities that could occur prior to licensing with staff's approval. Tier 3 would identify those construction activities that could only occur after licensing.
Given the diverse nature of materials licensees, the NRC would need to develop a thorough and comprehensive LWA program that would be available to all materials licensees to the extent practicable and adequate to ensure that the radiological health and safety of the public and common defense and security is protected. There is insufficient information on the record of this rulemaking from which the NRC can develop such a process or even determine whether such a process is feasible. Thus, the NRC is not establishing an LWA process for materials licenses at this time. The NRC may consider this issue in more detail in a future rulemaking.
We, too, do not understand applicable NRC regulations or statutes to prohibit outright NFS's construction activities. But the Petitioners undoubtedly are correct that our rules “
In short, NFS proceeds at its own risk with construction activities. If NFS begins or continues to construct buildings associated with license amendments for which the Staff's environmental review is incomplete, NFS's construction may prove grounds for denial of one or more of the license amendments.
The decision in
As is discussed in more detail in Section III, Discussion, NEPA is largely a procedural statute, which requires that the NRC undertake environmental review of its licensing actions. In implementing the requirements of NEPA, the NRC has determined in § 51.101(a)(2) that taking action that would have an adverse environmental impact, or would limit the choice of reasonable alternatives may be grounds for denial of a license, and includes within these designations the provisions in §§ 30.33(a)(5), 40.32(e), and 70.23(a)(7). Furthermore, as is also discussed further in Section III, Discussion, § 161.b of the AEA confers on the NRC the authority to establish by rule and regulation such standards as the NRC “deems necessary or desirable” to ensure the public health and safety from radiological hazards, including limitations on an applicant's or licensee's ability to engage in construction, which it did when it initially promulgated §§ 30.33(a)(5), 40.32(e), and 70.23(a)(7).
It is also important to note that the Commission limited its finding in
By identifying those site preparation activities that are not considered construction, the NRC avoids piecemeal regulation and licensing actions and brings more uniformity to the application of the NRC's regulatory authority to matters of construction. The NRC cannot “choose” to extend its authority beyond the limits of the AEA and require applicants to get prior permission to perform activities that are not within our statutory authority.
By virtue of the exemption process that exists in Part 40, the NRC has had the opportunity to identify some activities that have a reasonable nexus to radiological health and safety and would therefore constitute construction. For instance, most recently in response to an exemption request submitted by Lost Creek ISR, LLC (ADAMS Accession No. ML091940438) the NRC has previously determined that certain activities are “construction,” including construction of the processing plant, which serves to concentrate, precipitate, and dry yellowcake; and construction of any structure or system to manage waste, such as deep disposal wells (ADAMS Accession No. ML093350365).
It would, however, be prudent of a materials license applicant that is engaging in site preparation activities to be mindful of the NRC's obligations under the NHPA, including the requirements to identify any historic properties within the area of potential effects, to consult with the State Historic Preservation Officer (SHPO) and any other relevant stakeholders (such as Native American Tribes), and to attempt to resolve any adverse effects upon such historic properties. These procedural requirements must be satisfied by the NRC before it can approve the subject application (assuming all radiological health and safety and common defense and security requirements are met). For example, § 110k. of the NHPA requires that before granting a license the NRC ensure that an applicant has not “intentionally significantly adversely affected a historic property to which the [license] would relate, or having legal power to prevent it, allowed such significant adverse effect to occur * * *” with the intent of avoiding NRC review of the effect of the proposed licensing action on “any district, site, building, structure, or object that is included in or eligible for inclusion in the National Register.” Section 106 of the NHPA. Accordingly, a materials license applicant should proceed carefully when engaging site preparation activities undertaken lest the outcome impacts the NRC's ability to issue a license.
In order to facilitate and expedite the NRC's NHPA process, materials license applicants are encouraged to contact any potential stakeholders who may have an interest in any historic properties on or near the site and to take steps to prevent or minimize any disturbance to such historic properties. In this regard, materials license applicants are also encouraged, upon the discovery of previously unknown historic properties, archeological resources or other cultural artifacts, to cease any such activities that may disturb or damage such resources and, inventory and evaluate the discovery in accordance with accepted historic preservation and archeological practices (see the U.S. Secretary of the Interior's Standards and Guidelines for Identification at
Comments received on this rule have questioned whether the NRC is unnecessarily limiting its authority to matters concerning “radiological” health and safety or common defense and security considerations. The majority of the commenters opposed to this rule believe that the AEA confers much broader authority to the NRC to consider a broader range of health and safety or common defense and security concerns.
As indicated in the proposed rule, the NRC has determined that the AEA does not authorize the NRC to require an applicant for an NRC license to obtain the NRC's permission before undertaking site preparation activities that do not implicate radiological health and safety or common defense and security considerations. This interpretation is not new and has been reviewed and upheld repeatedly by the Courts. In 1969, the U.S. Court of Appeals for the First Circuit reviewed this issue in
It is important to note that while the Uranium Mill Tailings Radiation Control Act of 1978 (UMTRCA) amended the AEA to give the NRC the authority necessary “to protect the public health and safety and the environment from radiological and non-radiological hazards associated with the processing and with the possession of such material * * *” with respect to certain byproduct material (§ 84.a.(1) of the AEA), the NRC's authority over non-radiological hazards is limited to those hazards specifically associated with the processing and possession of byproduct material. Contrary to some of the commenters assertions, UMTRCA did not operate to expand the NRC's jurisdiction to private actions not specifically associated with the processing or possession of radioactive material.
A second set of commenters also questions whether the NRC has authority to impose a prohibition against construction on materials licensees. While the NRC's authority to protect the public health and safety may be limited to radiological hazards, its primary authority under the AEA is grounded in its authority to grant, deny and condition licenses for certain nuclear materials and facilities. With respect to materials licenses, the NRC has authority over the manufacture, production, transfer, possession, use, ownership, import and export of radioactive material.
Establish by rule, regulation, or order, such standards and instructions to govern the possession and use of special nuclear material, source material, and byproduct material as the Commission may deem necessary or desirable to promote the common defense and security or to protect [the radiological] health or to minimize danger to life or property [from radiological hazards].
It is this grant of authority that allows the NRC to establish as a condition of licensing that materials license applicants not engage in construction impacting common defense and security or public health and safety with respect to radiological hazards prior to the completion of the environmental review for the licensed facility.
As previously indicated, the AEA does not authorize the NRC to require an applicant to obtain permission before undertaking site preparation activities that do not implicate radiological health and safety or common defense and security. These activities, being outside of the scope of the NRC's jurisdiction are, therefore, considered to be non-Federal actions, at least with respect to the NRC's licensing actions. Such activities might trigger other Federal authority if, for example, they were to take place on Federal lands in accordance with a Bureau of Land Management lease. As set forth in the Statement of Consideration for the proposed rule, the NRC believes that this rule is fully compliant with the requirements of NEPA. The NEPA obligations and responsibilities arise only when the Commission undertakes a Federal action within the NRC's statutory responsibility.
Contrary to the statements of some commenters, the courts have consistently determined that NEPA is a procedural statute, and as such it cannot and does not expand the NRC's jurisdiction beyond the scope of the AEA;
[W]hile NEPA may require the NRC to consider the environmental effects caused by the exercise of its permitting/licensing authority, the statute cannot be the source of the expansion of the NRC's authority to require * * * other forms of permission for activities that are not reasonably related to radiological health and safety or protection of the common defense and security. Since NEPA cannot expand the Commission's * * * authority under the AEA, the elimination of the blanket inclusion of site preparation activities in the [then existing] definition of construction does not violate NEPA.
The commenters also claim that the NRC is inappropriately segmenting the site preparation activities from the licensed facility construction activities at the site to avoid NEPA. This is not the case. Generally, the NEPA segmentation problem arises when the environmental impacts of Federal actions are evaluated in a piecemeal fashion and, as a result, the comprehensive environmental impacts of the entire Federal action are never considered or are only considered after the agency has committed itself to continuation of the project. Another associated segmentation problem arises when pieces of a Federal action are evaluated separately and, as a result, none of the individual pieces are considered “major Federal actions” requiring an EIS.
The site preparation activities identified in the rule are activities that any private entity can undertake on
While the effects of any non-Federal site preparation activities undertaken by a materials license applicant will not be considered effects of the NRC's licensing action, the effects of the site preparation activities would be considered as part of the NRC's cumulative impact analysis performed during the environmental review of the licensing action. Cumulative impacts are defined as the “impact on the environment that results from the incremental impact of the action when added to other past, present, and reasonably foreseeable future actions.” 40 CFR 1508.7. In accordance with its guidance on this issue, the NRC staff's cumulative impacts analysis will identify and describe effects of past, proposed, and reasonably foreseeable future actions to the extent that they are relevant and useful in determining the magnitude and significance of the effects of the proposed NRC licensing action. See NUREG-1748, “Environmental Review Guidance for Licensing Actions Associated with NMSS Programs.” Similar to the LWA Rulemaking, the NRC is revising § 51.60 to require that the environmental report submitted with an application for a materials license or an amendment to a materials license include a description of the site preparation activities undertaken at the proposed site; a description of the impacts of such site preparation activities; and an analysis of the cumulative impacts of the site preparation activities on the proposed licensing action.
With respect to the comments regarding other environmental protection statutes, the NRC remains committed to fulfilling its obligations under these statutes during its review of any license action. It is important to note, however, that each of the statutes applies specifically to the NRC only to the extent that an activity comes within the NRC's licensing authority or is a “Federal undertaking” by the NRC. For the same reasons previously stated, site preparation activities are not part of the NRC licensing action process and as such do not constitute either a “major Federal action,” or a “Federal undertaking” by the NRC.
Section 30.4 is amended by adding definitions for the terms “construction” and “commencement of construction.”
The amendment to § 30.33(a)(5) deletes the definition of “commencement of construction” contained in the last two sentences of the paragraph. “Commencement of construction” is now defined in § 30.4.
Section 36.2 is amended by adding definitions for the terms “construction” and “commencement of construction.”
Section 36.13(a) is amended to exclude § 30.33(a)(5) as a requirement for an applicant to receive a specific license under this part. The provision in § 30.33(a)(5) pertains to “commencement of construction.” “Commencement of construction” provisions for Part 36 licenses are already contained in § 36.15.
The amendment in § 36.15 revises the section title “Start of construction” to “Commencement of construction” and deletes the definition of “construction.” The definitions of “commencement of construction” and “construction” are now defined in § 36.2.
Section 39.13 is amended to change the reference to § 70.33 to § 70.23.
Section 40.4 is amended by adding definitions for the terms “construction” and “commencement of construction.”
The amendment to § 40.32(e) deletes the definition of “commencement of construction” contained in the last two sentences of the paragraph. “Commencement of construction” is now defined in § 40.4.
The amendment to § 51.4 clarifies that the definition of “construction” applies to materials licenses.
The amendment to § 51.45(c) corrects the reference to § 51.4, and describes additional information that the environmental report for materials licenses should contain.
Section 70.4 is amended by adding definitions for the terms “construction” and “commencement of construction.”
The amendment to § 70.23(a)(7) deletes the definition of “commencement of construction” contained in the last two sentences of the paragraph. “Commencement of construction” is now defined in § 70.4.
Section 150.31(b)(3)(iv) is revised to include definitions for “commencement of construction” and “construction.”
Under the “Policy Statement on Adequacy and Compatibility of Agreement State Programs” which became effective on September 3, 1997 (62 FR 46517), this final rule is a matter of compatibility between the NRC and Agreement States, thereby providing consistency among the Agreement States and the NRC's requirements. The NRC program elements (including regulations) are placed into Compatibility Categories A, B, C, D, NRC, or adequacy category, Health and Safety (H&S). Category A includes program elements that are basic radiation protection standards or related definitions, signs, labels, or terms necessary for a common understanding of radiation protection principles and should be essentially identical to those of the NRC. Category B includes
Compatibility Category C includes those program elements that do not meet the criteria of Categories A or B but nonetheless are consistent with an Agreement State's efforts to avoid conflict, duplication, gaps, or other conditions that would jeopardize an orderly pattern in the regulation of agreement material on a nationwide basis. Therefore, the program elements in Compatibility Category C should be adopted by Agreement States.
Compatibility Category D includes those program elements that do not meet any of the criteria of Category A, B, or C, and do not need to be adopted by Agreement States.
Compatibility Category NRC consists of those program elements that address areas of regulation that cannot be relinquished to Agreement States pursuant to the AEA or provisions of Title 10 of the
Category H&S consist of program elements that are not required for compatibility, but have a particular health and safety role (
The NRC has analyzed this final rule in accordance with the procedure established within Part III, “Categorization Process for NRC Program Elements,” of Handbook 5.9 to Management Directive 5.9, “Adequacy and Compatibility of Agreement State Programs” (a copy of which may be viewed at
The National Technology Transfer and Advancement Act of 1995 (Pub. L. 104-113), requires that Federal agencies use technical standards that are developed or adopted by voluntary consensus standards bodies, unless the use of such a standard is inconsistent with applicable law or otherwise impractical. In this final rule, the NRC is clarifying those activities that constitute “construction” for materials licenses. This action does not constitute the establishment of a standard that contains generally applicable requirements.
The NRC has determined that this final rule is the type of action described as a categorical exclusion in 10 CFR 51.22(c)(1), (c)(2), and (c)(3)(i). Section 51.22(c)(1) provides a categorical exclusion for amendments to various parts of the NRC's regulations, including Part 150. Section 51.22(c)(2) provides a categorical exclusion for amendments to the NRC's regulations which are of a corrective or minor or nonpolicy nature and do not substantially modify existing regulations. Section 51.22(c)(3)(i) provides a categorical exclusion for amendments to any part of the NRC's regulations which relate to procedures for filing and reviewing applications, amendments, or renewals for licenses or other forms of permission. In this final rule, the amendments to Parts 30, 40, 36, and 70 relate to the procedures for reviewing applications, amendments, and renewals of materials licenses subject to these parts. The amendments to Part 39 correct a typographical error, and the remaining amendments are to Part 150. Because these amendments belong to a category of actions which the NRC has previously found do not individually or cumulatively have a significant effect on the human environment, neither an environmental impact statement nor an environmental assessment has been prepared for this rule.
This final rule does not contain new or amended information collection requirements subject to the Paperwork Reduction Act of 1995 (44 U.S.C. 3501
The NRC may not conduct or sponsor, and a person is not required to respond to, a request for information or an information collection requirement unless the requesting document displays a currently valid OMB control number.
A regulatory analysis has not been prepared for this regulation. This rule amends the NRC's regulations to conform the definitions of “construction” and “commencement of construction” as they appear in Parts 30, 36, 40, 70, and 150, to the Parts 50, 51, and 52 definitions implemented by the LWA Rulemaking, revised to reference non-nuclear power plant licensees. This amendment does not impose any new burden or reporting requirements on the licensee or the NRC for compliance. Also, this rule does not involve an exercise of NRC discretion and therefore does not necessitate preparation of a regulatory analysis.
In accordance with the Regulatory Flexibility Act (5 U.S.C. 605(b)), the NRC certifies that this rule will not have a significant economic impact on a substantial number of small entities. This rule affects only materials licensees. The companies that apply for a license in accordance with the regulations affected by this rule do not fall within the scope of the definition of “small entities” set forth in the Regulatory Flexibility Act or the size standards established by the NRC (10 CFR 2.810).
The NRC has determined that this final rule is not subject to any of the backfitting provisions in 10 CFR 50.109, 70.76, 72.62, 76.76, or the finality provision of 10 CFR part 52. The amendments in this rule do not involve any provisions that would impose backfits on nuclear power plant licensees as defined in 10 CFR parts 50 or 52, or on licensees for gaseous diffusion plants, independent spent fuel storage installations or special nuclear material as defined in 10 CFR parts 70, 72 and 76, respectively; therefore, a backfit analysis is not required. With respect to Parts 30, 36, 39, and 40 licensees, the NRC has determined that there are no provisions for backfit in these parts; therefore, the NRC has not prepared a backfit analysis or any other documentation for this final rule.
In accordance with the Congressional Review Act of 1996, the NRC has determined that this action is not a major rule and has verified this
Byproduct material, Criminal penalties, Government contracts, Intergovernmental relations, Isotopes, Nuclear materials, Radiation protection, Reporting and recordkeeping requirements.
Byproduct material, Criminal penalties, Nuclear materials, Reporting and recordkeeping requirements, Scientific equipment, Security measures.
Byproduct material, Criminal penalties, Nuclear materials, Oil and gas exploration—well logging, Reporting and recordkeeping requirements, Scientific equipment, Security measures, Source material, Special nuclear material.
Criminal penalties, Government contracts, Hazardous materials transportation, Nuclear materials, Reporting and recordkeeping requirements, Source material, Uranium.
Administrative practice and procedure, Environmental impact statement, Nuclear materials, Nuclear power plants and reactors, Reporting and recordkeeping requirements.
Criminal penalties, Hazardous materials transportation, Material control and accounting, Nuclear materials, Packaging and containers, Radiation protection, Reporting and recordkeeping requirements, Scientific equipment, Security measures, Special nuclear material.
Criminal penalties, Hazardous materials transportation, Intergovernmental relations, Nuclear materials, Reporting and recordkeeping requirements, Security measures, Source material, Special nuclear material.
For the reasons set out in the preamble and under the authority of the Atomic Energy Act of 1954, as amended; the Energy Reorganization Act of 1974, as amended; and 5 U.S.C. 552 and 553; the NRC is adopting the following amendments to 10 CFR parts 30, 36, 39, 40, 51, 70, and 150.
Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-58, 119 Stat. 549 (2005).
Section 30.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851). Section 30.34(b) also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 30.61 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
(1) Radiological health and safety; or
(2) Common defense and security.
(1) Changes for temporary use of the land for public recreational purposes;
(2) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;
(3) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;
(4) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to this part;
(5) Excavation;
(6) Erection of support buildings (
(7) Building of service facilities (
(8) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or
(9) Taking any other action that has no reasonable nexus to:
(i) Radiological health and safety, or
(ii) Common defense and security.
(a) * * *
(5) In the case of an application for a license to receive and possess byproduct material for the conduct of any activity which the NRC determines will significantly affect the quality of the environment, the Director, Office of Federal and State Materials and Environmental Management Programs or his/her designee, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to subpart A of part 51 of this chapter, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to such conclusion shall be grounds for denial of a license to receive and possess byproduct material in such plant or facility. Commencement of construction as defined in § 30.4 may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.
Secs. 81, 82, 161, 182, 183, 186, 68 Stat. 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846).
(1) Radiological health and safety; or
(2) Common defense and security.
(1) Changes for temporary use of the land for public recreational purposes;
(2) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;
(3) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;
(4) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to this part;
(5) Excavation;
(6) Erection of support buildings (
(7) Building of service facilities (
(8) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or
(9) Taking any other action that has no reasonable nexus to:
(i) Radiological health and safety, or
(ii) Common defense and security.
(a) The applicant shall satisfy the general requirements specified in §§ 30.33(a)(1)-(4) and 30.33(b) of this chapter and the requirements contained in this part.
Commencement of construction of a new irradiator may not occur prior to the submission to the NRC of both an application for a license for the irradiator and the fee required by § 170.31 of this chapter. Any activities undertaken prior to the issuance of a license are entirely at the risk of the applicant and have no bearing on the issuance of a license with respect to the requirements of the Atomic Energy Act of 1954 (Act), as amended, and rules, regulations, and orders issued under the Act. Commencement of construction as defined in § 36.2 may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.
Secs. 53, 57, 62, 63, 65, 69, 81, 82, 161, 182, 183, 186, 68 Stat. 929, 930, 932, 933, 934, 935, 948, 953, 954, 955, as amended, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2073, 2077, 2092, 2093, 2095, 2099, 2111, 2112, 2201, 2232, 2233, 2236, 2282); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note).
(a) The applicant shall satisfy the general requirements specified in § 30.33 of this chapter for byproduct material, in § 40.32 of this chapter for source material, and in § 70.23 of this chapter for special nuclear material, as appropriate, and any special requirements contained in this part.
Secs. 62, 63, 64, 65, 81, 161, 182, 183, 186, 68 Stat. 932, 933, 935, 948, 953, 954, 955, as amended, secs. 11e(2), 83, 84, Pub. L. 95-604, 92 Stat. 3033, as amended, 3039, sec. 234, 83 Stat. 444, as amended (42 U.S.C. 2014(e)(2), 2092, 2093, 2094, 2095, 2111, 2113, 2114, 2201, 2232, 2233, 2236, 2282); sec. 274, Pub. L. 86-373, 73 Stat. 688 (42 U.S.C. 2021); secs. 201, as amended, 202, 206, 88 Stat. 1242, as amended, 1244, 1246 (42 U.S.C. 5841, 5842, 5846); sec. 275, 92 Stat. 3021, as amended by Pub. L. 97-415, 96 Stat. 2067 (42 U.S.C. 2022); sec. 193, 104 Stat. 2835, as amended by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-59, 119 Stat. 594 (2005).
Section 40.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851). Section 40.31(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 40.46 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 40.71 also issued under sec. 187, 68 Stat. 955 (42 U.S.C. 2237).
(1) Radiological health and safety; or
(2) Common defense and security.
(1) Changes for temporary use of the land for public recreational purposes;
(2) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;
(3) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;
(4) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to this part;
(5) Excavation;
(6) Erection of support buildings (
(7) Building of service facilities (
(8) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or
(9) Taking any other action that has no reasonable nexus to:
(i) Radiological health and safety, or
(ii) Common defense and security.
(e) In the case of an application for a license for a uranium enrichment facility, or for a license to possess and use source and byproduct material for uranium milling, production of uranium hexafluoride, or for the conduct of any other activity which the NRC determines will significantly affect the quality of the environment, the Director, Office of Federal and State Materials and Environmental Management Programs or his/her designee, before commencement of construction, on the basis of information filed and evaluations made pursuant to subpart A of part 51 of this chapter, has concluded, after weighing the environmental, economic, technical and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to this conclusion is grounds for denial of a license to possess and use source and byproduct material in the plant or facility. Commencement of construction as defined in § 40.4 may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.
Sec. 161, 68 Stat. 948, as amended, sec. 1701, 106 Stat. 2951, 2952, 2953, (42 U.S.C. 2201, 2297f); secs. 201, as amended, 202, 88 Stat. 1242, as amended, 1244 (42 U.S.C. 5841, 5842); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note). Subpart A also issued under National Environmental Policy Act of 1969, secs. 102, 104, 105, 83 Stat. 853-854, as amended (42 U.S.C. 4332, 4334, 4335); and Pub. L. 95-604, Title II, 92 Stat. 3033-3041; and sec. 193, Pub. L. 101-575, 104 Stat. 2835 (42 U.S.C. 2243). Sections 51.20, 51.30, 51.60, 51.80. and 51.97 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241, and sec. 148, Pub. L. 100-203, 101 Stat. 1330-223 (42 U.S.C. 10155, 10161, 10168). Section 51.22 also issued under sec. 274, 73 Stat. 688, as amended by 92 Stat. 3036-3038 (42 U.S.C. 2021) and under Nuclear Waste Policy Act of 1982, sec. 121, 96 Stat. 2228 (42 U.S.C. 10141). Sections 51.43, 51.67, and 51.109 also issued under Nuclear Waste Policy Act of 1982, sec. 114(f), 96 Stat. 2216, as amended (42 U.S.C. 10134(f)).
(1) For production and utilization facilities, the activities in paragraph (1)(i) of this definition, and does not mean the activities in paragraph (1)(ii) of this definition.
(i) Activities constituting construction are the driving of piles, subsurface preparation, placement of backfill, concrete, or permanent retaining walls within an excavation, installation of foundations, or in-place assembly, erection, fabrication, or testing, which are for:
(A) Safety-related structures, systems, or components (SSCs) of a facility, as defined in 10 CFR 50.2;
(B) SSCs relied upon to mitigate accidents or transients or used in plant emergency operating procedures;
(C) SSCs whose failure could prevent safety-related SSCs from fulfilling their safety-related function;
(D) SSCs whose failure could cause a reactor scram or actuation of a safety-related system;
(E) SSCs necessary to comply with 10 CFR part 73;
(F) SSCs necessary to comply with 10 CFR 50.48 and criterion 3 of 10 CFR part 50, appendix A; and
(G) Onsite emergency facilities (
(ii) Construction does not include:
(A) Changes for temporary use of the land for public recreational purposes;
(B) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;
(C) Preparation of a site for construction of a facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;
(D) Erection of fences and other access control measures that are not safety or security related, and do not pertain to radiological controls;
(E) Excavation;
(F) Erection of support buildings (
(G) Building of service facilities (
(H) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility;
(I) Manufacture of a nuclear power reactor under a manufacturing license under subpart F of part 52 of this chapter to be installed at the proposed site and to be part of the proposed facility; or
(J) With respect to production or utilization facilities, other than testing
(2) For materials licenses, taking any site-preparation activity at the site of a facility subject to the regulations in 10 CFR parts 30, 36, 40, and 70 that has a reasonable nexus to radiological health and safety or the common defense and security; provided, however, that construction does not mean:
(i) Those actions or activities listed in paragraphs (1)(ii)(A)-(H) of this definition; or
(ii) Taking any other action that has no reasonable nexus to radiological health and safety or the common defense and security.
(c)
Secs. 51, 53, 161, 182, 183, 68 Stat. 929, 930, 948, 953, 954, as amended, sec. 234, 83 Stat. 444, as amended, (42 U.S.C. 2071, 2073, 2201, 2232, 2233, 2282, 2297f); secs. 201, as amended, 202, 204, 206, 88 Stat. 1242, as amended, 1244, 1245, 1246 (42 U.S.C. 5841, 5842, 5845, 5846). Sec. 193, 104 Stat. 2835 as amended by Pub. L. 104-134, 110 Stat. 1321, 1321-349 (42 U.S.C. 2243); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. 109-58, 119 Stat. 194 (2005).
Sections 70.1(c) and 70.20a(b) also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161).
Section 70.7 also issued under Pub. L. 95-601, sec. 10, 92 Stat. 2951 as amended by Pub. L. 102-486, sec. 2902, 106 Stat. 3123 (42 U.S.C. 5851). Section 70.21(g) also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 70.31 also issued under sec. 57d, Pub. L. 93-377, 88 Stat. 475 (42 U.S.C. 2077). Sections 70.36 and 70.44 also issued under sec. 184, 68 Stat. 954, as amended (42 U.S.C. 2234). Section 70.81 also issued under secs. 186, 187, 68 Stat. 955 (42 U.S.C. 2236, 2237). Section 70.82 also issued under sec. 108, 68 Stat. 939, as amended (42 U.S.C. 2138).
(1) Radiological health and safety; or
(2) Common defense and security.
(1) Changes for temporary use of the land for public recreational purposes;
(2) Site exploration, including necessary borings to determine foundation conditions or other preconstruction monitoring to establish background information related to the suitability of the site, the environmental impacts of construction or operation, or the protection of environmental values;
(3) Preparation of the site for construction of the facility, including clearing of the site, grading, installation of drainage, erosion and other environmental mitigation measures, and construction of temporary roads and borrow areas;
(4) Erection of fences and other access control measures that are not related to the safe use of, or security of, radiological materials subject to this part;
(5) Excavation;
(6) Erection of support buildings (
(7) Building of service facilities (
(8) Procurement or fabrication of components or portions of the proposed facility occurring at other than the final, in-place location at the facility; or
(9) Taking any other action that has no reasonable nexus to:
(i) Radiological health and safety, or
(ii) Common defense and security.
(a) * * *
(7) Where the proposed activity is processing and fuel fabrication, scrap recovery, conversion of uranium hexafluoride, uranium enrichment facility construction and operation, or any other activity which the NRC determines will significantly affect the quality of the environment, the Director of Nuclear Material Safety and Safeguards or his/her designee, before commencement of construction of the plant or facility in which the activity will be conducted, on the basis of information filed and evaluations made pursuant to subpart A of part 51 of this chapter, has concluded, after weighing the environmental, economic, technical, and other benefits against environmental costs and considering available alternatives, that the action called for is the issuance of the proposed license, with any appropriate conditions to protect environmental values. Commencement of construction prior to this conclusion is grounds for denial to possess and use special nuclear material in the plant or facility. Commencement of construction as defined in section 70.4 may include non-construction activities if the activity has a reasonable nexus to radiological safety and security.
Sec. 161, 68 Stat. 948, as amended, sec. 274, 73 Stat. 688 (42 U.S.C. 2201, 2021); sec. 201, 88 Stat. 1242, as amended (42 U.S.C. 5841); sec. 1704, 112 Stat. 2750 (44 U.S.C. 3504 note); Energy Policy Act of 2005, Pub. L. No. 109-58, 119 Stat. 594 (2005).
Sections 150.3, 150.15, 150.15a, 150.31, 150.32 also issued under secs. 11e(2), 81, 68 Stat. 923, 935, as amended, secs. 83, 84, 92 Stat. 3033, 3039 (42 U.S.C. 2014e(2), 2111, 2113, 2114). Section 150.14 also issued under sec. 53, 68 Stat. 930, as amended (42 U.S.C. 2073).
Section 150.15 also issued under secs. 135, 141, Pub. L. 97-425, 96 Stat. 2232, 2241 (42 U.S.C. 10155, 10161). Section 150.17a also issued under sec. 122, 68 Stat. 939 (42 U.S.C. 2152). Section 150.30 also issued under sec. 234, 83 Stat. 444 (42 U.S.C. 2282).
(b) * * *
(3) * * *
(iv) Prohibit commencement of construction with respect to such material prior to complying with the provisions of paragraph (b)(3)(iii) of this section. As used in this paragraph:
(A) The term
(B) The term
(
(
(
(
(
(
(
(
(
For the Nuclear Regulatory Commission.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class E airspace at Grand Junction, CO. Additional controlled airspace is necessary to facilitate vectoring of Instrument Flight Rules (IFR) traffic from Grand Junction Regional Airport to en route and enhances the safety and management of aircraft operations at the airport. This action also amends Class D and Class E airspace to update the airport name from Grand Junction, Walker Field.
Effective date, 0901 UTC, December 15, 2011. The Director of the Federal Register approves this incorporation by reference action under 1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Eldon Taylor, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue, SW., Renton, WA 98057; telephone (425) 203-4537.
On July 8, 2011, the FAA published in the
Class D and Class E airspace designations are published in paragraph 5000, 6002, 6004 and 6005, respectively, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class D and Class E airspace designations listed in this document will be published subsequently in that Order.
This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E airspace at Grand Junction Regional Airport, Grand Junction, CO. Additional controlled airspace extending upward from 1,200 feet above the surface is necessary to accommodate vectoring IFR aircraft departing Grand Junction Regional Airport to en route airspace. This action also amends Class D and Class E airspace to update the airport name from Grand Junction, Walker Field, to Grand Junction Regional Airport, Grand Junction, CO.
The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it creates additional controlled airspace at Grand Junction Regional Airport, Grand Junction, CO.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR Part 71 as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from the surface to and including 7,400 feet MSL within a 4.7-mile radius of Grand Junction Regional Airport. This Class D airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
Within a 4.7-mile radius of Grand Junction Regional Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from the surface within 1.8 miles each side of the Grand Junction Regional Airport Runway 11 ILS localizer northwest course extending from the 4.7-mile radius of Grand Junction Regional Airport to 7 miles northwest of the localizer.
That airspace extending upward from 700 feet above the surface within 7 miles northwest and 4.3 miles southeast of the Grand Junction VOR/DME 247° and 067° radials extending from 11.4 miles southwest to 12.3 miles northeast of the VOR/DME, and within 1.8 miles south and 9.2 miles north of the Grand Junction VOR/DME 110° radial extending from the VOR/DME to 19.2 miles southeast; that airspace extending upward from 1,200 feet above the surface within a 33.1-mile radius of the Grand Junction VOR/DME beginning at the 020° bearing of the Grand Junction VOR/DME, clockwise to the 270° bearing of the Grand Junction VOR/DME, and within a 63-mile radius of the Grand Junction VOR/DME beginning at the 270° bearing of the Grand Junction VOR/DME, clockwise to the 020° bearing of the Grand Junction VOR/DME.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class E airspace at Dawson Community Airport, Glendive, MT, to accommodate aircraft using Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures. This improves the safety and management of
Effective date, 0901 UTC, December 15, 2011. The Director of the Federal Register approves this incorporation by reference action under 1 CFR part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Eldon Taylor, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue, SW., Renton, WA 98057; telephone (425) 203-4537.
On July 13, 2011, the FAA published in the
Class E airspace designations are published in paragraph 6005, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.
This action amends Title 14 Code of Federal Regulations (14 CFR) part 71 by modifying Class E airspace, extending upward from 700 feet above the surface, at Dawson Community Airport, to accommodate IFR aircraft executing RNAV (GPS) standard instrument approach procedures at the airport. This action is necessary for the safety and management of IFR operations. Except for an editorial change in the airspace designation from [Modify] to [Modified], this rule is the same as that published in the notice of proposed rulemaking July 13, 2011.
The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it modifies controlled airspace at Dawson Community Airport, Glendive, MT.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR part 71 as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E. O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
That airspace extending upward from 700 feet above the surface within a 10.5-mile radius of the Dawson Community Airport, and within 4 miles northeast and 8.3 miles southwest of the 325° bearing from the Dawson Community Airport extending from the 10.5-mile radius to 16.1 miles northwest of the airport; that airspace extending upward from 1,200 feet above the surface within an area bounded by lat. 47°38′00″ N., long. 104°48′00″ W.; to lat. 47°17′00″ N., long. 104°05′00″ W.; to lat. 46°54′00″ N., long. 104°05′00″ W.; to lat. 46°45′00″ N., long. 105°09′00″ W.; to lat. 47°00′00″ N., long. 105°37′00″ W.; to lat. 47°19′00″ N., long. 105°15′00″ W., thence to the point of beginning.
Federal Aviation Administration (FAA), DOT.
Final rule.
This action modifies Class E airspace at Tonopah, NV, to accommodate aircraft using new Area Navigation (RNAV) Global Positioning System (GPS) standard instrument approach procedures at Tonopah Airport, NV. This action also makes a minor adjustment to the geographic coordinates of the airport, and corrects geographic coordinates in the regulatory text. This rule improves the safety and management of Instrument Flight Rules (IFR) operations at the airport.
Effective date, 0901 UTC, December 15, 2011. The Director of the Federal Register approves this incorporation by reference action under 1 CFR Part 51, subject to the annual revision of FAA Order 7400.9 and publication of conforming amendments.
Eldon Taylor, Federal Aviation Administration, Operations Support Group, Western Service Center, 1601 Lind Avenue, SW., Renton, WA 98057; telephone (425) 203-4537.
On July 8, 2011, the FAA published in the
Class E airspace designations are published in paragraph 6002 and 6005, respectively, of FAA Order 7400.9V dated August 9, 2011, and effective September 15, 2011, which is incorporated by reference in 14 CFR 71.1. The Class E airspace designations listed in this document will be published subsequently in that Order.
This action amends Title 14 Code of Federal Regulations (14 CFR) Part 71 by modifying Class E surface airspace, and Class E airspace extending upward from 700 feet above the surface, at Tonopah Airport, Tonopah, NV, to accommodate IFR aircraft executing new RNAV (GPS) standard instrument approach procedures at the airport. Also, the geographic coordinates of the airport are updated to coincide with the FAA's aeronautical database. Additionally, the latitude and longitude coordinates in the text of Class E airspace listed under paragraph 6005 are adjusted to be in concert with the FAA's aeronautical database. This action is necessary for the safety and management of IFR operations. With the exception of editorial changes and the changes noted above, this rule is the same as that proposed in the notice of proposed rulemaking July 8, 2011.
The FAA has determined this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. Therefore, this regulation: (1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. Since this is a routine matter that will only affect air traffic procedures and air navigation, it is certified this rule, when promulgated, will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act. The FAA's authority to issue rules regarding aviation safety is found in Title 49 of the U.S. Code. Subtitle 1, Section 106 discusses the authority of the FAA Administrator. Subtitle VII, Aviation Programs, describes in more detail the scope of the agency's authority. This rulemaking is promulgated under the authority described in Subtitle VII, Part A, Subpart I, Section 40103. Under that section, the FAA is charged with prescribing regulations to assign the use of airspace necessary to ensure the safety of aircraft and the efficient use of airspace. This regulation is within the scope of that authority as it creates additional controlled airspace at Tonopah Airport, Tonopah, NV.
Airspace, Incorporation by reference, Navigation (air).
In consideration of the foregoing, the Federal Aviation Administration amends 14 CFR Part 71 as follows:
49 U.S.C. 106(g), 40103, 40113, 40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959-1963 Comp., p. 389.
Within a 8.2-mile radius of the Tonopah Airport and within 2 miles each side of the 358° bearing from the Tonopah Airport extending from the 8.2-mile radius to 10.5 miles north of the Tonopah Airport, and within 2 miles each side of the Tonopah Airport 117° bearing extending from the 8.2-mile radius to 11.5 miles southeast of the Tonopah Airport. This Class E airspace area is effective during the specific dates and times established in advance by a Notice to Airmen. The effective date and time will thereafter be continuously published in the Airport/Facility Directory.
That airspace extending upward from 700 feet above the surface within a 10.7-mile radius of the Tonopah Airport, and that airspace northwest of the Tonopah Airport bounded by a line beginning at lat. 38°10′16″ N., long. 117°15′50″ W.; to lat. 38°12′00″ N., long. 117°17′00″ W.; to lat. 38°18′00″ N., long. 117°17′00″ W.; to lat. 38°18′00″ N., long. 117°03′00″ W.; to lat. 38°14′13″ N., long. 117°03′13″ W.; thence clockwise via the 10.7-mile radius of the Tonopah Airport to lat. 38°00′36″ N., long. 116°52′13″ W.; to lat. 38°00′09″ N., long. 116°51′06″ W.; to lat. 37°56′35″ N., long. 116°53′24″ W.; to lat. 37°57′02″ N., long. 116°54′31″ W.; thence clockwise via the 10.7-mile radius of the Tonopah Airport to the point of beginning. That airspace extending upward from 1,200 feet above the surface within the area bounded by a line beginning at lat. 37°52′46″ N., long. 117°05′41″ W.; to lat. 37°39′00″ N., long. 117°22′00″ W.; to lat. 37°35′00″ N., long. 117°36′00″ W.; to lat. 37°56′00″ N., long. 117°54′00″ W.; to lat. 37°56′50″ N., long. 117°32′00″ W.; to lat. 38°08′00″ N., long. 117°41′00″ W.; to lat. 38°18′00″ N., long. 117°24′00″ W.; to lat. 38°18′00″ N., long. 117°00′00″ W.; to lat. 38°14′00″ N., long. 117°00′00″ W.; to lat. 38°17′00″ N., long. 116°36′00″ W.; to lat. 38°00′00″ N., long. 116°33′00″ W.; to lat. 37°59′30″ N., long. 116°38′30″ W.; to lat. 37°53′00″ N., long. 116°38′30″ W.; thence to the point of beginning.
Federal Aviation Administration (FAA), DOT.
Final rule.
This establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient
This rule is effective September 15, 2011. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of September 15, 2011.
Availability of matters incorporated by reference in the amendment is as follows:
1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591;
2. The FAA Regional Office of the region in which the affected airport is located;
3. The National Flight Procedures Office, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or
2. The FAA Regional Office of the region in which the affected airport is located.
Harry J. Hodges, Flight Procedure Standards Branch (AFS-420), Flight Technologies and Programs Divisions, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (Mail Address: P.O. Box 25082, Oklahoma City, OK 73125) Telephone: (405) 954-4164.
This rule amends Title 14 of the Code of Federal Regulations, Part 97 (14 CFR part 97), by establishing, amending, suspending, or revoking SIAPS, Takeoff Minimums and/or ODPS. The complete regulators description of each SIAP and its associated Takeoff Minimums or ODP for an identified airport is listed on FAA form documents which are incorporated by reference in this amendment under 5 U.S.C. 552(a), 1 CFR part 51, and 14 CFR 97.20. The applicable FAA Forms are FAA Forms 8260-3, 8260-4, 8260-5, 8260-15A, and 8260-15B when required by an entry on 8260-15A.
The large number of SIAPs, Takeoff Minimums and ODPs, in addition to their complex nature and the need for a special format make publication in the
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP, Takeoff Minimums and ODP as contained in the transmittal. Some SIAP and Takeoff Minimums and textual ODP amendments may have been issued previously by the FAA in a Flight Data Center (FDC) Notice to Airmen (NOTAM) as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for some SIAP and Takeoff Minimums and ODP amendments may require making them effective in less than 30 days. For the remaining SIAPS and Takeoff Minimums and ODPS, an effective date at least 30 days after publication is provided.
Further, the SIAPs and Takeoff Minimums and ODPS contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these SIAPS and Takeoff Minimums and ODPs, the TERPS criteria were applied to the conditions existing or anticipated at the affected airports. Because of the close and immediate relationship between these SIAPs, Takeoff Minimums and ODPs, and safety in air commerce, I find that notice and public procedures before adopting these SIAPS, Takeoff Minimums and ODPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making some SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT Regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, and Navigation (Air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal Regulations, Part 97 (14 CFR part 97) is amended by establishing, amending, suspending, or revoking Standard Instrument Approach Procedures and/or Takeoff Minimums and/or Obstacle Departure Procedures effective at 0902 UTC on the dates specified, as follows:
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
Federal Aviation Administration (FAA), DOT.
Final rule.
This rule establishes, amends, suspends, or revokes Standard Instrument Approach Procedures (SIAPs) and associated Takeoff Minimums and Obstacle Departure Procedures for operations at certain airports. These regulatory actions are needed because of the adoption of new or revised criteria, or because of changes occurring in the National Airspace System, such as the commissioning of new navigational facilities, adding new obstacles, or changing air traffic requirements. These changes are designed to provide safe and efficient use of the navigable airspace and to promote safe flight operations under instrument flight rules at the affected airports.
This rule is effective September 15, 2011. The compliance date for each SIAP, associated Takeoff Minimums, and ODP is specified in the amendatory provisions.
The incorporation by reference of certain publications listed in the regulations is approved by the Director of the Federal Register as of September 15, 2011.
Availability of matter incorporated by reference in the amendment is as follows:
1. FAA Rules Docket, FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591;
2. The FAA Regional Office of the region in which the affected airport is located;
3. The National Flight Procedures Office, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 or
4. The National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202-741-6030, or go to:
All SIAPs are available online free of charge. Visit
1. FAA Public Inquiry Center (APA-200), FAA Headquarters Building, 800 Independence Avenue, SW., Washington, DC 20591; or
2. The FAA Regional Office of the region in which the affected airport is located.
Harry J. Hodges, Flight Procedure Standards Branch (AFS-420) Flight Technologies and Programs Division, Flight Standards Service, Federal Aviation Administration, Mike Monroney Aeronautical Center, 6500 South MacArthur Blvd., Oklahoma City, OK 73169 (
This rule amends Title 14, Code of Federal Regulations, part 97 (14 CFR part 97) by amending the referenced SIAPs. The complete regulatory description of each SIAP is listed on the appropriate FAA Form 8260, as modified by the National Flight Data Center (FDC)/Permanent Notice to Airmen (P-NOTAM), and is incorporated by reference in the amendment under 5 U.S.C. 552(a), 1 CFR part 51, and § 97.20 of Title 14 of the Code of Federal Regulations.
The large number of SIAPs, their complex nature, and the need for a special format make their verbatim publication in the
This amendment to 14 CFR part 97 is effective upon publication of each separate SIAP as amended in the transmittal. For safety and timeliness of change considerations, this amendment incorporates only specific changes contained for each SIAP as modified by FDC/P-NOTAMs.
The SIAPs, as modified by FDC P-NOTAM, and contained in this amendment are based on the criteria contained in the U.S. Standard for Terminal Instrument Procedures (TERPS). In developing these changes to SIAPs, the TERPS criteria were applied only to specific conditions existing at the affected airports. All SIAP amendments in this rule have been previously issued by the FAA in a FDC NOTAM as an emergency action of immediate flight safety relating directly to published aeronautical charts. The circumstances which created the need for all these SIAP amendments requires making them effective in less than 30 days.
Because of the close and immediate relationship between these SIAPs and safety in air commerce, I find that notice and public procedure before adopting these SIAPs are impracticable and contrary to the public interest and, where applicable, that good cause exists for making these SIAPs effective in less than 30 days.
The FAA has determined that this regulation only involves an established body of technical regulations for which frequent and routine amendments are necessary to keep them operationally current. It, therefore—(1) Is not a “significant regulatory action” under Executive Order 12866; (2) is not a “significant rule” under DOT regulatory Policies and Procedures (44 FR 11034; February 26, 1979); and (3) does not warrant preparation of a regulatory evaluation as the anticipated impact is so minimal. For the same reason, the FAA certifies that this amendment will not have a significant economic impact on a substantial number of small entities under the criteria of the Regulatory Flexibility Act.
Air traffic control, Airports, Incorporation by reference, and Navigation (Air).
Accordingly, pursuant to the authority delegated to me, Title 14, Code of Federal regulations, part 97, 14 CFR part 97, is amended by amending Standard Instrument Approach Procedures, effective at 0901 UTC on the dates specified, as follows:
49 U.S.C. 106(g), 40103, 40106, 40113, 40114, 40120, 44502, 44514, 44701, 44719, 44721-44722.
By amending: § 97.23 VOR, VOR/DME, VOR or TACAN, and VOR/DME or TACAN; § 97.25 LOC, LOC/DME, LDA, LDA/DME, SDF, SDF/DME; § 97.27 NDB, NDB/DME; § 97.29 ILS, ILS/DME, MLS, MLS/DME, MLS/RNAV; § 97.31 RADAR SIAPs; § 97.33 RNAV SIAPs; and § 97.35 COPTER SIAPs, Identified as follows:
Office of National Marine Sanctuaries (ONMS), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of availability; response to comments.
The Office of National Marine Sanctuaries (ONMS) has developed final policy and permitting guidance for submarine cable projects proposed in national marine sanctuaries. This action identifies the criteria the ONMS will use to ensure that applications to install and maintain submarine cables in sanctuaries are reviewed consistently and in a manner that adheres to the National Marine Sanctuaries Act and ONMS regulations (15 CFR part 922). The ONMS is releasing its final policy and permitting guidance, and responding to comments on the interim policy.
This notice of availability is effective as a final policy as of September 15, 2011.
Copies of the final policy and permit guidance for submarine cable projects may be viewed and downloaded at
Vicki Wedell, (301) 713-3125.
Internal Revenue Service (IRS), Treasury.
Correcting amendment.
This document contains corrections to final regulations and removal of temporary regulations (TD 9542) that were published in the
This correction is effective on September 15, 2011 and is applicable August 16, 2011.
R. Matthew Kelley, (202) 622-7900 (not a toll-free number).
The final regulations and removal of temporary regulations that are the subject of this document are under sections 195, 248, and 709 of the Internal Revenue Code.
As published, the final regulations and removal of temporary regulations (TD 9542) contain errors that may prove to be misleading and are in need of clarification.
Income taxes, Reporting and recordkeeping requirements.
Accordingly, 26 CFR part 1 is corrected by making the following correcting amendments:
26 U.S.C. 7805 * * *.
(b) * * *
(4) * * *
($36,000 − $1,200 = $34,800) ratably over the remaining 174 months.
($54,000 − $1,800 = $ 52,200) ratably over the remaining 174 months.
($450,000 − $15,000 = $435,000) ratably over the remaining 174 months.
Pension Benefit Guaranty Corporation.
Final rule.
This final rule amends the Pension Benefit Guaranty Corporation's regulations on Benefits Payable in Terminated Single-Employer Plans and Allocation of Assets in Single-Employer Plans to prescribe interest assumptions under the benefit payments regulation for valuation dates in October 2011 and interest assumptions under the asset allocation regulation for valuation dates in the fourth quarter of 2011. The interest assumptions are used for valuing and paying benefits under terminating single-employer plans
Effective October 1, 2011.
Catherine B. Klion (
PBGC's regulations on Allocation of Assets in Single-Employer Plans (29 CFR part 4044) and Benefits Payable in Terminated Single-Employer Plans (29 CFR part 4022) prescribe actuarial assumptions—including interest assumptions—for valuing and paying plan benefits under terminating single-employer plans covered by title IV of the Employee Retirement Income Security Act of 1974. The interest assumptions in the regulations are also published on PBGC's Web site (
The interest assumptions in Appendix B to Part 4044 are used to value benefits for allocation purposes under ERISA section 4044. PBGC uses the interest assumptions in Appendix B to Part 4022 to determine whether a benefit is payable as a lump sum and to determine the amount to pay. Appendix C to Part 4022 contains interest assumptions for private-sector pension practitioners to refer to if they wish to use lump-sum interest rates determined using PBGC's historical methodology. Currently, the rates in Appendices B and C of the benefit payment regulation are the same.
The interest assumptions are intended to reflect current conditions in the financial and annuity markets. Assumptions under the asset allocation regulation are updated quarterly; assumptions under the benefit payments regulation are updated monthly. This final rule updates the benefit payments interest assumptions for October 2011 and updates the asset allocation interest assumptions for the fourth quarter (October through December) of 2011.
The fourth quarter 2011 interest assumptions under the allocation regulation will be 4.07 percent for the first 20 years following the valuation date and 4.28 percent thereafter. In comparison with the interest assumptions in effect for the third quarter of 2011, these interest assumptions represent a decrease of five years in the select period (the period during which the select rate (the initial rate) applies), a decrease of 0.14 percent in the select rate, and a decrease of 0.06 percent in the ultimate rate (the final rate).
The October 2011 interest assumptions under the benefit payments regulation will be 1.75 percent for the period during which a benefit is in pay status and 4.00 percent during any years preceding the benefit's placement in pay status. In comparison with the interest assumptions in effect for September 2011, these interest assumptions represent a decrease of 0.50 percent in the immediate annuity rate and are otherwise unchanged.
PBGC has determined that notice and public comment on this amendment are impracticable and contrary to the public interest. This finding is based on the need to determine and issue new interest assumptions promptly so that the assumptions can reflect current market conditions as accurately as possible.
Because of the need to provide immediate guidance for the valuation and payment of benefits under plans with valuation dates during October 2011, PBGC finds that good cause exists for making the assumptions set forth in this amendment effective less than 30 days after publication.
PBGC has determined that this action is not a “significant regulatory action” under the criteria set forth in Executive Order 12866.
Because no general notice of proposed rulemaking is required for this amendment, the Regulatory Flexibility Act of 1980 does not apply. See 5 U.S.C. 601(2).
Employee benefit plans, Pension insurance, Pensions, Reporting and recordkeeping requirements.
Employee benefit plans, Pension insurance, Pensions.
In consideration of the foregoing, 29 CFR parts 4022 and 4044 are amended as follows:
29 U.S.C. 1302, 1322, 1322b, 1341(c)(3)(D), and 1344.
29 U.S.C. 1301(a), 1302(b)(3), 1341, 1344, 1362.
Environmental Protection Agency (EPA).
Direct final rule.
EPA is taking direct final action to approve a State Implementation Plan (SIP) revision submitted by the State of West Virginia. The revision amends the 8-hour ozone maintenance plans for the Charleston, Huntington, Parkersburg, Weirton, and Wheeling 8-hour ozone maintenance areas. This revision amends the maintenance plans' 2009 and 2018 motor vehicle emissions budgets (MVEBs) by reallocating a portion of the plans' safety margins which results in an increase in the MVEBs. The revised plans continue to demonstrate maintenance of the 8-hour national ambient air quality standard (NAAQS) for ozone. EPA is approving this SIP revision to the West Virginia maintenance plans for the Charleston, Huntington, Parkersburg, Weirton, and Wheeling 8-hour ozone maintenance areas in accordance with the requirements of the Clean Air Act (CAA).
This rule is effective on November 14, 2011 without further notice, unless EPA receives adverse written comment by October 17, 2011. If EPA receives such comments, it will publish a timely withdrawal of the direct final rule in the
Submit your comments, identified by Docket ID Number EPA-R03-OAR-2011-0511 by one of the following methods:
A.
B.
C.
D.
Martin Kotsch, (215) 814-3335, or by e-mail at
Throughout this document whenever “we,” “us,” or “our” is used, we mean EPA.
On July 11, 2006 (71 FR 39001), EPA redesignated the Charleston area of West Virginia to attainment for the 8-hour ozone NAAQS. For the Charleston area, the redesignation included approval of an 8-hour ozone maintenance plan, which identifies on-road MVEBs for volatile organic compounds (VOCs) and nitrogen oxides (NO
On September 15, 2006 (71 FR 54421), EPA redesignated the Huntington-Ashland area of West Virginia to attainment for the 8-hour ozone NAAQS. For the Huntington area, the redesignation included approval of an 8-hour ozone maintenance plan, which identifies on-road MVEBs for VOCs and NO
On May 8, 2007 (72 FR 25967), EPA redesignated the Parkersburg-Marietta area of West Virginia to attainment for the 8-hour ozone NAAQS. For the Parkersburg area, the redesignation included approval of an 8-hour ozone maintenance plan, which identifies on-road MVEBs for VOCs and NO
On May 14, 2007 (72 FR 27060), EPA redesignated the Steubenville-Weirton area of West Virginia to attainment for the 8-hour ozone NAAQS. For the Weirton area, the redesignation included approval of an 8-hour ozone maintenance plan, which identifies on-road MVEBs for VOCs and NO
On May 15, 2007 (72 FR 27247), EPA redesignated the Wheeling area of West Virginia to attainment for the 8-hour ozone NAAQS. For the Wheeling area, the redesignation included approval of an 8-hour ozone maintenance plan, which identifies on-road MVEBs for VOCs and NO
For all five of the nonattainment areas, the MVEBs are being revised to account for the new EPA emissions model called Motor Vehicle Emissions Simulator (MOVES) which by March 3, 2012 must be used for all new transportation conformity determinations which occur after that date. During early testing, it was found that mobile vehicle emissions using MOVES were predicted to be higher now than when using the older EPA model MOBILE6. The MOBILE6 emissions model was utilized in developing the MVEBs contained in the approved maintenance plan for each area. To account for this anticipated increase in predicted mobile emissions, West Virginia has revised its existing MVEBs in each area using available safety margins which is allowable.
On March 14, 2011, the State of West Virginia submitted to EPA a formal revision to its SIP. The SIP revision proposes new MVEBs for the Charleston, Huntington, Parkersburg, Weirton, and Wheeling 8-hour ozone maintenance areas, to reflect the reallocation of a portion of the differences (safety margins) between the total base year and total projected 2009 and 2018 8-hour ozone maintenance emissions, which produces an increase in the MVEBs. The base year is 2004 for all the 8 hour ozone maintenance areas. By increasing the MVEBs, the West Virginia Department of Environmental Protection (WVDEP) is ensuring that transportation conformity can be demonstrated in all 8-hour ozone maintenance areas. The March 14, 2011 submittal, while increasing the MVEBs, still ensures maintenance of the NAAQS for ozone for all of the Charleston, Huntington, Parkersburg, Weirton, and Wheeling 8-hour ozone maintenance areas.
Tables 1 and 2 describe the basis of the new revised MVEBs for the Charleston area.
For the Charleston, West Virginia 8-hour ozone maintenance area addressed herein, the WVDEP increased the 2009 and 2018 MVEBs using available safety margins to allow for projected increases in emissions as predicted by the MOVES model. The 2009 and 2018 MVEBs for VOCs and NO
The State has proposed reallocating some of the emissions from the current safety margin into the MVEBs for both VOCs and NO
To explain how the safety margins are determined and allocated for all the nonattainment areas, the NO
For the Huntington area, Tables 3 and 4 describe the basis of the new revised MVEBs and the overall emissions for the area.
For the Parkersburg area, Tables 5 and 6 describe the basis of the new revised MVEBs and the overall emissions for the area.
For the Weirton area, Tables 7 and 8 describe the basis of the new revised MVEBs and the overall emissions for the area.
For the Wheeling area, Tables 9 and 10 describe the basis of the new revised MVEBs and the overall emissions for the area.
EPA is approving West Virginia's SIP revision submitted on March 14, 2011, which amends the 8-hour ozone maintenance plans for the Charleston, Huntington, Parkersburg, Weirton, and Wheeling 8-hour ozone maintenance areas. These revisions amend the maintenance plans' 2009 and 2018 MVEBs to reflect the reallocation of a portion of the plans' safety margins which results in an increase in the MVEBs. EPA is approving this SIP revision to the maintenance plans for these areas because this revision continues to demonstrate maintenance of the 8-hour ozone NAAQS. EPA is publishing this rule without prior proposal because the Agency views this as a noncontroversial amendment and anticipates no adverse comment, since no significant adverse comments were received on the SIP revision at the State level. However, in the Proposed Rules section of today's
If EPA receives adverse comment, EPA will publish a timely withdrawal in the
Under the CAA, the Administrator is required to approve a SIP submission that complies with the provisions of the CAA and applicable Federal regulations. 42 U.S.C. 7410(k); 40 CFR 52.02(a). Thus, in reviewing SIP submissions, EPA's role is to approve state choices, provided that they meet the criteria of the CAA. Accordingly, this action merely approves state law as meeting Federal requirements and does not impose additional requirements beyond those imposed by state law. For that reason, this action:
• Is not a “significant regulatory action” subject to review by the Office of Management and Budget under Executive Order 12866 (58 FR 51735, October 4, 1993);
• Does not impose an information collection burden under the provisions of the Paperwork Reduction Act (44 U.S.C. 3501
• Is certified as not having a significant economic impact on a substantial number of small entities under the Regulatory Flexibility Act (5 U.S.C. 601
• Does not contain any unfunded mandate or significantly or uniquely affect small governments, as described in the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4);
• Does not have Federalism implications as specified in Executive Order 13132 (64 FR 43255, August 10, 1999);
• Is not an economically significant regulatory action based on health or safety risks subject to Executive Order 13045 (62 FR 19885, April 23, 1997);
• Is not a significant regulatory action subject to Executive Order 13211 (66 FR 28355, May 22, 2001);
• Is not subject to requirements of Section 12(d) of the National Technology Transfer and Advancement Act of 1995 (15 U.S.C. 272 note) because application of those requirements would be inconsistent with the CAA; and
• Does not provide EPA with the discretionary authority to address, as appropriate, disproportionate human health or environmental effects, using practicable and legally permissible methods, under Executive Order 12898 (59 FR 7629, February 16, 1994).
In addition, this rule does not have tribal implications as specified by Executive Order 13175 (65 FR 67249, November 9, 2000), because the SIP is not approved to apply in Indian country located in the state, and EPA notes that it will not impose substantial direct costs on tribal governments or preempt tribal law.
The Congressional Review Act, 5 U.S.C. 801
Under section 307(b)(1) of the CAA, petitions for judicial review of this action must be filed in the United States Court of Appeals for the appropriate circuit by November 14, 2011. Filing a petition for reconsideration by the Administrator of this final rule does not affect the finality of this action for the purposes of judicial review nor does it extend the time within which a petition for judicial review may be filed, and shall not postpone the effectiveness of such rule or action. Parties with objections to this direct final rule are encouraged to file a comment in response to the parallel notice of proposed rulemaking for this action published in the proposed rules section of today's
This action to approve the West Virginia 8 hour ozone maintenance plan revisions may not be challenged later in proceedings to enforce its requirements. (See section 307(b)(2).)
Environmental protection, Air pollution control, Incorporation by reference, Nitrogen dioxide, Ozone, Reporting and recordkeeping requirements, Volatile organic compounds.
40 CFR Part 52 is amended as follows:
42 U.S.C. 7401
(e) EPA-approved nonregulatory and quasi-regulatory material.
(a) EPA approves the following revised 2009 and 2018 motor vehicle emissions budgets (MVEBs) for the Charleston, West Virginia 8-hour ozone maintenance area submitted by the Secretary of the Department of Environmental Protection on March 14, 2011:
(b) EPA approves the following revised 2009 and 2018 motor vehicle emissions budgets (MVEBs) for the Huntington, West Virginia 8-hour ozone maintenance area submitted by the Secretary of the Department of Environmental Protection on March 14, 2011:
(c) EPA approves the following revised 2009 and 2018 motor vehicle emissions budgets (MVEBs) for the Parkersburg, West Virginia 8-hour ozone maintenance area submitted by the Secretary of the Department of Environmental Protection on March 14, 2011:
(d) EPA approves the following revised 2009 and 2018 motor vehicle emissions budgets (MVEBs) for the Weirton, West Virginia 8-hour ozone maintenance area submitted by the Secretary of the Department of Environmental Protection on March 14, 2011:
(e) EPA approves the following revised 2009 and 2018 motor vehicle emissions budgets (MVEBs) for the Wheeling, West Virginia 8-hour ozone maintenance area submitted by the Secretary of the Department of Environmental Protection on March 14, 2011:
Environmental Protection Agency (EPA).
Withdrawal of direct final rule.
On July 25, 2011, EPA published a direct final rule approving portions of three revisions to the Texas State Implementation Plan (SIP) submitted on August 31, 1993; July 22, 1998; and October 5, 2010. The revisions amend existing sections and create new sections in Title 30 of the Texas Administrative Code (TAC), Chapter 116—Control of Air Pollution by Permits for New Construction or Modification. The August 31, 1993, revision creates two new sections at 30 TAC 116.174 and 116.175 for the use of emission reductions as offsets in new source review permitting. The July 22, 1998, revision creates 30 TAC 116.116(f) allowing for the use of Discrete Emission Reduction Credits (DERC) to exceed emission limits in permits (permit allowables) and amends 30 TAC 116.174 to update internal citations to other Texas regulations. The October 5, 2010, revision amends 30 TAC 116.116(f) to update internal citations to other Texas regulations. The direct final action was published without prior proposal because EPA anticipated no adverse comments. EPA stated in the direct final rule that if we received relevant, adverse comments by August 24, 2011, EPA would publish a timely withdrawal in the
The direct final rule published on July 25, 2011 (76 FR 44271), is withdrawn as of September 15, 2011.
Ms. Erica Le Doux (6PD-R), Air Permits Section, Environmental Protection Agency, Region 6, 1445 Ross Avenue (6PD-R), Suite 1200, Dallas, TX 75202-2733. The telephone number is (214) 665-7265. Ms. Le Doux can also be reached via electronic mail at
Environmental protection, Air pollution control, Carbon monoxide, Incorporation by reference, Intergovernmental relations, Lead, Nitrogen dioxide, Ozone, Particulate matter, Reporting and recordkeeping requirements, Sulfur oxides, Volatile organic compounds.
Accordingly, the amendments to 40 CFR 52.2270 published in the
Environmental Protection Agency (EPA).
Establishment of Class VI Program.
EPA is announcing the establishment of a Federal Underground Injection Control (UIC) Class VI Program for Carbon Dioxide (CO
The national Class VI Program is effective as of September 7, 2011.
Lisa McWhirter, Underground Injection Control Program, Drinking Water Protection Division, Office of Ground Water and Drinking Water (MC-4606M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
This action applies to all State and Tribal governments and owners or operators of injection wells that will be used to inject CO
This table is not intended to be an exhaustive list; rather it provides a guide for readers regarding entities that this action applies to. This action could also apply to other types of entities not listed in the table. To determine
1.
2.
On December 10, 2010, EPA finalized minimum Federal requirements under the Safe Drinking Water Act (SDWA) for underground injection of CO
Under 40 CFR 145.21(h) in the Code of Federal Regulations (CFR), EPA provided States 270 days, from December 10, 2010, to submit a complete primary enforcement responsibility (primacy) application for implementation of the Class VI Program that met the requirements of 40 CFR 145.22 or 145.32 (75 FR 77242). While the Agency has worked with States interested in applying for Class VI Program primacy, as of September 6, 2011, EPA has not received or approved any complete primacy applications.
In the preamble to the Class VI Final Rule (75 FR 77242), EPA clarified that, in light of national priorities for promoting climate change mitigation strategies and Administration priorities for developing and deploying CCS projects in the next few years as highlighted in the “Report of the Interagency Task Force on Carbon Capture and Storage” (August 2010), it is important to have enforceable Class VI regulations in place nationwide as soon as possible. As a result, in the Class VI Final Rule, EPA provided that the Federal rule would become effective in every State that had not submitted a primacy application within the 270-day transition period provided by SDWA. The Agency committed to publishing, in the
As a result, beginning September 7:
• The “transitional period” during which States were able to use existing UIC authorities (
• A State may no longer issue Class I permits for CO
• Until a State receives primacy for the Class VI Program, a State may not issue Class VI UIC permits (75 FR 77243) under SDWA. All permit applications for GS projects must be directed to the appropriate EPA Region in order for a Class VI permit to be issued (75 FR 77243). EPA encourages owners or operators to contact EPA Regions regarding existing and future GS projects. EPA Regions will work with States that are considering applying for Class VI primacy, where possible, to ensure that Class VI permits are designed in a way that will be compatible with the final State Program requirements. EPA expects the majority, if not all, of the wells injecting CO
• As provided in 40 CFR 146.81(c), owners or operators of either Class I wells previously permitted for the purpose of GS or Class V experimental technology wells no longer being used for experimental purposes that will continue injection of CO
• A State may, at any time in the future, apply for Class VI Program primacy following establishment of a Federal Class VI UIC Program. If a State receives Class VI Program primacy approval in the future, EPA will publish a subsequent
National Telecommunications and Information Administration, U.S. Department of Commerce.
Final rule.
The National Telecommunications and Information Administration (NTIA) hereby makes certain changes to its regulations, which relate to the public availability of the Manual of Regulations and Procedures for Federal Radio Frequency Management (NTIA Manual). Specifically, NTIA updates the version of the Manual of Regulations and Procedures for Federal Radio Frequency Management with which federal agencies must comply when requesting use of the radio frequency spectrum.
This regulation is effective on September 15, 2011. The incorporation by reference of certain publications listed in the rule is approved by the Director of the Federal Register as of September 15, 2011.
A reference copy of the NTIA Manual, including all revisions in effect, is available in the Office of Spectrum Management, 1401 Constitution Avenue, NW., Room 1087, Washington, DC 20230.
William Mitchell, Office of Spectrum Management, at (202) 482-8124 or
NTIA authorizes the U.S. Government's use of the radio frequency spectrum. 47 U.S.C. 902(b)(2)(A). As part of this authority, NTIA developed the NTIA Manual to provide further guidance to applicable federal agencies. The NTIA Manual is the compilation of policies and procedures that govern the use of the radio frequency spectrum by the U.S. Government. Federal government agencies are required to follow these policies and procedures in their use of the spectrum.
Part 300 of title 47 of the Code of Federal Regulations provides information about the process by which NTIA regularly revises the NTIA Manual and makes public this document and all revisions. Federal agencies are required to comply with the specifications in the NTIA Manual when requesting frequency assignments for use of the radio frequency spectrum.
This rule updates section 300.1(b) of title 47 of the Code of Federal Regulations to specify the version of the NTIA Manual with which federal agencies must comply when requesting frequency assignments for use of the radio frequency spectrum. In particular, this rule amends section 300.1(b) by replacing “September 2010” with “May 2011.”
The NTIA Manual is scheduled for revision in January, May, and September of each year and is submitted to the Director of the Federal Register for Incorporation by Reference approval. The Director of the Federal Register approved this incorporation by reference in accordance with 5 U.S.C. 552(a) and part 51 of title 1 of the Code of Federal Regulations. The NTIA Manual is available from the Superintendent of Documents, U.S. Government Printing Office, Washington, DC 20402, by referring to Catalog Number 903-008-00000-8. A reference copy of the NTIA Manual, including all revisions in effect, is available in the Office of Spectrum Management, 1401 Constitution Avenue, NW., Room 1087, Washington, DC 20230, or call William Mitchell on (202) 482-8124, and available online at
This action does not contain collection of information requirements subject to the Paperwork Reduction Act (PRA). Notwithstanding any other provision of law, no person is required to respond to, nor shall any person be subject to a penalty for failure to comply with, a collection of information subject to the PRA, unless that collection displays a currently valid OMB Control Number.
This rule has been determined to be not significant for purposes of Executive Order 12866.
NTIA finds good cause under 5 U.S.C. 553(b)(B) to waive prior notice and opportunity for public comment as it is unnecessary. This action amends the regulations to include the date of the most current version of the NTIA Manual. These changes do not impact the rights or obligations of the public. The NTIA Manual applies only to federal agencies. Because these changes impact only federal agencies, NTIA finds it unnecessary to provide for the notice and comment requirements of 5 U.S.C. 553. NTIA also finds good cause under 5 U.S.C. 553(d)(3) to waive the 30-day delay in effectiveness for the reasons provided above. Because notice and opportunity for comment are not required pursuant to 5 U.S.C. 553 or any other law, the analytical requirements of the Regulatory Flexibility Act (5 U.S.C. 601
The NTIA Manual provides for the policies and procedures for federal agencies' use of the radio spectrum. The NTIA Manual and the changes thereto do not substantially affect the rights or obligations of the public. As a result, this notice is not a “rule” as defined by the Congressional Review Act, 5 U.S.C. 804(3)(C).
This rule does not contain policies having federalism implications as that term is defined in EO 13132.
Incorporation by reference; Radio.
For the reasons set forth in the preamble, NTIA amends title 47, Part 300 as follows:
47 U.S.C. 901 et seq., Executive Order 12046 (March 27, 1978), 43 FR 13349, 3 CFR 1978 Comp., p. 158.
(b) The federal agencies shall comply with the requirements set forth in the January 2008 edition of the NTIA Manual, as revised through May 2011, which is incorporated by reference with approval of the Director, Office of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51.
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Final rule.
This final rule partially approves Framework Adjustment (FW) 46 to the NE Multispecies Fishery Management Plan (FMP), which increases the haddock incidental catch cap allocated to the Atlantic midwater trawl herring fishery to 1 percent of the Georges Bank (GB) haddock Acceptable Biological Catch (ABC) and to 1 percent of the Gulf of Maine (GOM) haddock ABC, thereby, adjusting final fishing year (FY) 2011 specifications for the other fishery components of these ABCs. In addition, this action modifies the method for estimating haddock catch in the herring fishery and the relevant accountability measures (AMs) such that, upon attainment of the cap, the midwater trawl herring fleet may not catch or land herring in excess of the incidental catch limit (2,000 lb (907.2 kg)) in or from the appropriate haddock stock area. In addition, in this action NMFS disapproves measures in FW 46 that would have required open access herring vessels using midwater trawl gear to report total kept catch, and notify the Office of Law Enforcement, prior to landing. NMFS also disapproves a measure to require all midwater trawl vessels to report gear used on each trip into the Gulf of Maine or Georges Bank. FW 46 was developed by the New England Fishery Management Council (Council) to address the haddock incidental catch cap in the Atlantic herring fishery to allow the herring fishery to achieve optimum yield, by establishing a better opportunity to fully harvest the available herring quota, while providing incentives for the midwater trawl fishery to minimize haddock catch and, ensuring that haddock catch is adequately controlled and monitored.
This rule is effective September 14, 2011, except for § 648.10(l), which will become effective September 28, 2011.
Copies of FW 46, its Regulatory Impact Review (RIR), the final environmental assessment (EA) prepared for this action, and the Initial Regulatory Flexibility Analysis (IRFA) prepared by the Council are available from Paul J. Howard, Executive Director, New England Fishery Management Council, 50 Water Street, Mill 2, Newburyport, MA 01950. A Final Regulatory Flexibility Analysis (FRFA) was prepared for this final rule and is comprised of the EA, the preamble, and the Classification sections of the final rule. The FW 46 EA/RIR/IRFA are also accessible via the Internet at
Melissa Vasquez, Fishery Policy Analyst,
A proposed rule to implement measures in FW 46 was published on July 19, 2011 (76 FR 42663), soliciting public comment through August 3, 2011. After review of all public comments, NMFS has approved several of the proposed measures in FW 46, determining that approved measures, as listed below, are consistent with the goals of the FMP as described in Amendment 16 to the FMP, the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act), and other applicable laws. These final measures are unchanged from those that were proposed.
The Atlantic herring fishery is currently allocated a sub-Annual Catch Limit (ACL) of haddock that is equal to 0.2 percent of the combined GOM and GB haddock ABCs, to account for haddock that is incidentally caught in the herring fishery. When this cap is reached, herring vessels are restricted to an incidental possession limit of 2,000 lb (907.2 kg) of herring per trip in specific portions of the GOM and GB, which effectively closes these areas to directed herring fishing. The Council initiated FW 46 in January 2011 to address industry concerns that the haddock incidental catch cap was becoming too constraining on the herring fishery, particularly given the increased, healthy biomass of haddock on GB and the fact that the commercial groundfish fishery is not likely able to harvest its own sub-ACL for these stocks. An early effective closure of the directed herring fishery as a result of catching the incidental catch cap could result in thwarting fishery participants from potentially achieving optimum yield and limiting the supply of herring bait to the lobster fishery. For example, in FY 2010, the herring fishery was constrained by the cap and had to modify its behavior, which may have resulted in up to $5.5 million in foregone herring from Herring Management Area 3. Thus, the Council developed FW 46 to revise the haddock incidental catch cap for the Atlantic herring fishery to allow for the achievement of optimum yield through establishing a better opportunity to fully harvest the available herring quota, while providing incentives for the midwater trawl herring fishery to minimize haddock catch, and ensuring that haddock catch is adequately controlled and monitored. A complete discussion of the development of FW 46 and the pre-FW 46 haddock incidental catch cap measures and their rationale appears in the preamble to the proposed rule and is not repeated here.
FW 46, as submitted by the Council, required all midwater trawl vessels (including any vessel issued an open access incidental herring permit (Category D)) to report total catch kept. NMFS has partially disapproved this measure as it applies to a Category D vessel, because it determined that additional reporting by Category D vessels is not necessary at this time and would be an unnecessary reporting burden contrary to National Standard 7 of the Magnuson-Stevens Act, given that weekly VTR submissions (as implemented by a recent regulatory amendment to the Atlantic Herring FMP, 76 FR 54385; September 1, 2011) is sufficient to monitor this small component of the herring fishery.
In addition, although FW 46, as submitted by the Council, also required a midwater trawl vessel to report gear when reporting total kept catch prior to landing, in this rule, NMFS disapproves that measure because NMFS has determined that it would not be necessary for the timely monitoring of the proposed haddock incidental catch caps and, therefore, would be an unnecessary reporting burden contrary to National Standard 7 of the Magnuson-Stevens Act.
Although FW 46, as submitted by the Council, proposed to expand the current pre-landing hail requirements to all vessels using midwater trawl gear, NMFS disapproves that measure as it applied to an open access herring permit holder (Category D). Because Category D permits represent a small portion of the herring fishery, accounting for very little of the Atlantic herring landings (0.5 percent in FY 2010), and rarely using midwater trawl gear in applicable Areas (Category A vessels accounted for all landings by midwater trawl gear in FY 2008-2010), NMFS believes that requiring pre-landing hails of Category D vessels is an unnecessary reporting burden at this time, and is contrary to National Standard 7 of the Magnuson-Stevens Act.
To achieve the stated purposes of this action to maximize opportunities to fish for herring on GB, provide incentives to minimize the bycatch of haddock in the herring fishery, and reduce unnecessary economic impacts on the herring fishery, FW 46 replaces the current combined GOM and GB haddock incidental catch cap with separate stock-specific caps for the GOM and GB haddock stocks, equal to 1 percent of the GOM haddock ABC and 1 percent of the GB haddock ABC, respectively. These caps apply to all vessels with a Federal Atlantic herring permit of any category using midwater trawl gear (both single and paired midwater trawl vessels) in Herring Management Areas 1A, 1B, and/or 3. The stock-specific caps better account for differences between these two stocks and eliminate the possibility that catches of one stock could trigger the closure of both stock areas. The amount of the cap is calculated according to the procedures established by Amendment 16 for the setting of ACLs and sub-ACLs for various components of the fishery for each stock, and the cap calculation method revised by FW 44 to the FMP (see Appendix III to FW 44, available on the Council's
As noted in FW 46, these final measures are being implemented in-season, after the beginning of the 2011 Northeast multispecies (May 1, 2011-April 30, 2012) and herring (January 1, 2011-December 31, 2011) fishing years (FY). Therefore, this final rule revises the FY 2011 and FY 2012 sub-ACLs specified for the GOM haddock and GB haddock stocks in the FW 44 and FW 45 final rules, respectively (75 FR 18356; April 9, 2010 and 76 FR 23042; April 25, 2011) (see Table 1). The sub-ACLs published here supersede all other sub-ACLs specified for GOM and GB haddock in previous rules. Given that the haddock cap for the midwater trawl herring fishery is monitored based on the groundfish FY, upon publication of this final rule, NMFS will use observer data and other available data and information from applicable herring trips to estimate haddock catches by the herring fishery since the start of FY 2011 (beginning May 1, 2011). The catch estimate will then be counted against the increased stock-specific haddock caps.
This final rule revises the current haddock catch cap monitoring requirements such that only the haddock catches from vessels issued a Federal Atlantic herring permit and fishing with midwater trawl gear in Atlantic Herring Management Areas 1A, 1B, and/or 3 (GOM and GB) will be counted against the incidental haddock catch caps. Haddock catch reported by observers on observed herring trips using midwater trawl gear in Herring Management Areas 1A, 1B, and/or 3 will be extrapolated to estimate total haddock catch by the herring midwater trawl fleet in these herring management areas, for purposes of monitoring the attainment of each stock-specific cap. This extrapolation method contrasts to monitoring methods used prior to this rule, in which haddock caught was derived only from summing the reports of observers, dealers, vessels, and law enforcement officials.
FW 46 states that NMFS will develop the extrapolation methodology and post it on the Northeast Regional Office
A vessel with a Category A and/or B Atlantic herring permit is still required to land all haddock brought on deck or pumped into the hold, and may land up to 100 lb (45 kg) total of other regulated NE multispecies (§ 648.86(k)) per trip, but is prohibited from selling any groundfish for human consumption. In addition, these groundfish possession restrictions are revised to allow a Category C or D vessel and fishing any part of a trip with midwater trawl gear in Herring Management Areas 1A, 1B, or 3, to possess and land haddock and up to 100 lb (45 kg) of other groundfish, consistent with the revised scope of the cap. Consistent with the current requirements for a Category A or B vessel, such a Category C or D vessel is required to land all haddock, but is prohibited from selling it for human consumption. Additionally, NMFS has revised the regulations at § 648.86(k) to clarify that the 100 lb (45 kg) NE multispecies possession limit is meant to apply to NE. multispecies other than haddock.
FW 46 eliminates the current AM where all vessels issued an Atlantic herring permit are prohibited from possessing or landing herring in excess of the incidental herring limit in the entire GOM/GB Herring Exemption Area, once the combined GOM/GB haddock cap is reached. FW 46 instead establishes smaller, stock-specific AM areas (the “Herring GOM Haddock AM Area” and the “Herring GB Haddock AM Area”), which would only apply to a herring vessel using midwater trawl gear in the GOM and GB, upon attainment of the cap. The intent of this measure is to make the haddock catch caps less constraining on the herring fishery by accounting for differences between the haddock stocks, and by limiting the AMs to the herring midwater trawl fleet, which has been primarily responsible for haddock catches in the herring fishery. If the Regional Administrator determines that the haddock incidental catch cap for a specific haddock stock has been caught, any vessel issued a herring permit and using midwater trawl gear would be prohibited from fishing for, possessing, or landing herring in excess of 2,000 lb (907.2 kg) per trip in or from the applicable AM Area (see Tables 2 and 3). Additionally, the haddock possession/landing limit for the applicable AM Area would be reduced to 0 lb (0 kg) for herring midwater trawl vessels and all Category A and B vessels. For example, if the GOM haddock catch cap were reached, the herring possession limit would be reduced to the incidental catch level (2,000 lb (907 kg)) in the Herring GOM Haddock AM Area (see Table 2) for any vessel issued a herring permit and fishing any part of a trip with midwater trawl gear. Upon reaching the fishery haddock cap, a Category A or B vessel (regardless of gear used) or a Category C or D vessel fishing with midwater trawl gear would not be able to possess/land any haddock, but would still be able to land up to 100 lb (45 kg) of other NE. multispecies from the applicable AM area. In addition, in this example, a midwater trawl vessel would still be able to retain herring in or from areas of 1A, 1B, or 3 that do not overlap with the Herring GOM Haddock AM Area. A herring vessel that fishes both inside and outside of an AM Area for which the haddock cap has been triggered on a given trip would be required to comply with the most restrictive measures, meaning the vessel is restricted to the 2,000 lb (907 kg) herring possession limit for that trip. The reduced haddock possession/landing limit would not apply to a herring vessel that also holds a NE multispecies permit when it is on a declared NE. multispecies trip.
FW 46 implements an automatic haddock sub-ACL reduction as an additional AM, if the herring midwater trawl fishery haddock catch exceeds the incidental catch cap for the AM area in a given FY. If it is determined that the total catch of haddock by herring midwater trawl vessels exceeds either of the herring midwater trawl fishery GOM or GB haddock sub-ACLs for a FY, that sub-ACL would be reduced by the amount of the overage in the following FY. For example, if final accounting of the FY 2011 total haddock midwater trawl catch in the GOM haddock stock area indicates that the GOM haddock incidental catch cap had been exceeded by 5 mt, the FY 2012 GOM haddock sub-ACL for the herring midwater trawl fishery would be reduced by 5 mt to account for the overage that occurred during FY 2011. Any reductions to the midwater trawl haddock sub-ACLs would be announced by NMFS, consistent with the Administrative Procedure Act (APA), in the
Any vessel with a limited access herring permit (Category A, B, and C
The Council has initiated development of Amendment 5 to the Atlantic Herring FMP, which considers several alternatives that address interactions between the herring fishery and the groundfish fishery, and measures designed to improve catch monitoring. If approved, Amendment 5 would likely modify monitoring and reporting requirements for the herring fishery, including those that NMFS will use to monitor the proposed haddock incidental catch caps. Therefore, this rule provides the authority to the Regional Administrator to revise the reporting requirements implemented through this final rule, if the RA determines that revisions to such requirements are necessary to allow for the effective monitoring of the haddock incidental catch caps.
Any Category A and B vessel intending to use midwater trawl or purse seine gear on a declared herring trip, and any vessel issued a Category C and/or D herring permit and intending to fish or fishing any part of a trip with midwater trawl gear in Herring Management Areas 1A, 1B, or 3, is now required to notify the NMFS Northeast Fisheries Observer Program (NEFOP) at least 72 hrs prior to beginning a trip, and declare whether or not it intends to fish any part of a trip in Closed Area I (CAI).
A vessel issued a Category A or B permit, and on a declared herring trip fishing with midwater trawl or purse seine gear, and a vessel issued a Category C permit that fishes any part of a trip with midwater trawl gear in Herring Management Areas 1A, 1B, and/or 3, is now required to notify the NMFS Office of Law Enforcement through VMS of the time and place of offloading at least 6 hrs prior to crossing the VMS demarcation line, or at least 6 hrs prior to landing, if fishing inside the VMS demarcation line.
Any federally permitted herring dealer or processor (including at-sea processors) that culls or separates out non-herring catch in the course of normal operations is now required to separate out all haddock offloaded from any vessel issued any Federal herring permit that fished in Herring Areas 1A, 1B, and/or 3 with midwater trawl gear, and any vessel issued a Category A and/or B permit, regardless of gear used or area fished. In addition, such haddock may not be sold for any purpose and must be retained for at least 12 hrs on land to allow inspection by enforcement officials.
This final rule also revises the CA I restrictions regarding observers and net slippage for midwater trawl vessels, which are currently applicable to only Category A and B herring permit holders, by expanding these restrictions to any vessel issued a herring permit that fishes with midwater trawl gear in CA I. Thus, any vessel issued a herring permit is prohibited from fishing in CA I with midwater trawl gear without an observer. In addition, no vessel issued a herring permit and fishing with midwater trawl gear in CA I may release fish from the codend of the net, transfer fish to another vessel that is not carrying a NMFS-approved observer, or otherwise discard fish at sea, unless the fish has first been brought aboard the vessel and made available for sampling and inspection by the observer. All exemptions from the current requirements continue to apply to any vessel now subject to these restrictions.
There were six comments received on the proposed measures from one member of the public, three fishing industry organizations, and two coalitions of fishing and marine industry and environmental. Four commenters generally or partially supported the proposed measures, and two commenters generally opposed the action.
NMFS agrees with the Council that the haddock catch cap is an effective measure to create incentives to avoid haddock and, thus, has approved the catch cap for the herring fishery. NMFS believes, in light of Magnuson-Stevens Act provisions as discussed above, that the revised cap represents a better balance of controlling incidental catch and bycatch of haddock and other stocks, reducing uncertainty in the fishery, and providing the herring fishery a better opportunity to achieve optimum yield. Although maintaining the current cap at 0.2 percent of the combined GOM and GB haddock ABCs may have created a greater incentive for the midwater trawl fleet to avoid haddock, due to the lower relative current amount, this alternative was not practicable because it failed to meet other stated objectives of FW 46 and competing National Standards discussed above. Moreover, the approved measures increase the haddock catch cap, and revise the cap and associated AMs to be specific to those areas and gears that are primarily responsible for haddock catches, thereby substantially reducing the risk of negative economic impacts to the entire herring fleet, while still maintaining an incentive for that component of the fishery to avoid haddock. While the haddock catch cap is increased from 0.2 to 1 percent, a separate cap is established for each haddock stock, eliminating the possibility that the entire cap could be caught in one haddock stock area and threaten mortality targets for that haddock stock. Furthermore, FW 46 introduces a more comprehensive and effective method for more accurately estimating haddock catches across the fleet that will provide more direct control on total haddock catches by the midwater trawl fishery and reduce uncertainty for the herring fishery. Because this new method significantly differs from the current method of merely summing actual observed catches, it is not possible to conclude that the 1-percent haddock cap will result in a five-fold increase in the amount of haddock that may be caught by the herring fishery, as alleged by the commenters. For example, extrapolating haddock catches observed in 2006 under the current method showed that the estimated total catch of haddock was potentially nearly four times the 0.2-percent cap. Since the existing cap only counted observed catches of haddock, it did not monitor the overall catches of haddock by the entire fleet. In fact, when all of these changes are considered together, Framework 46 should result in more direct control on the total haddock catch by the fleet than the current 0.2-percent cap.
Furthermore, as described in the EA, the magnitude of catches from one stock area, as a proportion of biomass of these stocks, is not likely to have negative biological impacts on the status of the haddock stocks, or any effect on the populations of marine mammals or seabirds. In contrast, the revised haddock cap measures are likely to provide substantial economic benefits to the herring fishery, when compared to the no action alternative, without any negative biological impacts. Given these social and economic benefits, and that there is almost no likelihood of negative biological impacts, FW 46 achieves its stated objectives while minimizing bycatch to the extent practicable, consistent with the Magnuson-Stevens Act National Standards.
The herring fishery may be expected to be constrained under the current system more in future years than in the past. Although the herring fishery has not previously come close to achieving the cap, except for FY 2010, the herring fishery effort may be expected to increase in Area 3 as a result of area TAC allocations specified for the herring fishery in recent years. The Council reduced Area 1A TAC allocations through the FY 2010-2012 herring fishery specifications (75 FR 48874; August 12, 2010) to address concerns about the disproportionate amount of effort that exists on this inshore component of the herring stock, despite the fact that its constitutes only approximately 18 percent of the available biomass. The EA for the 2010-2012 herring specifications noted that higher Area 3 TACs (compared to Area 1A) might provide an opportunity for the herring fleet to regain yield lost from the Area 1A TAC reductions, but raised concerns that this effort might be inhibited by haddock bycatch measures. Given these steps by the Council to shift herring fishery effort to the offshore stock component, and continued declines in both herring and haddock stock biomasses and, subsequently, sub-ACLs, the herring fishery may be expected to bump up against the cap more frequently in future years under the no action alternative.
NMFS cannot prevent the Council from considering or proposing future changes to the haddock catch cap for the herring fishery. However, as noted above, any such change must be consistent with applicable law, including the competing mandates and considerations set forth in the Magnuson-Stevens Act under National Standards 1, 8, and 9. If any future changes to the haddock catch cap for the herring fishery are proposed, NMFS will evaluate that action on its own merit, independent from any previous management action, based on these and other national standards and applicable law, and consider further public
Regarding the suggestions to disapprove the measure or require a 75-percent reduction in haddock bycatch from previous years, NMFS can only approve, disapprove, or partially approve a Council action, but cannot modify the measures proposed in FW 46. Reducing the haddock cap by 75 percent from previous years represents a new management proposal and, as such, would require consideration and action by the Council as well as an opportunity for public comment on the measure. NMFS approved the measures proposed in FW 46 because they are consistent with the objectives of FW 46 and the NE Multispecies FMP, and other applicable laws, and will allow the prosecution of the herring fishery, while minimizing haddock catches by the herring fishery to the extent practicable.
The Council intended that the cap measures apply to all midwater trawl vessels, regardless of herring permit category, because this is the gear with documented catches of haddock. Although only Category A and B vessels have documented landings with midwater trawl gear, there is no prohibition on Category C or D vessels using midwater trawl gear, which is the gear most likely to catch haddock incidentally. The application of the measures to a Category C or D vessel imposes no burden unless such vessel chooses to use midwater trawl gear, in which case the relevance of the regulations are justified. Furthermore, future modifications to the Atlantic Herring FMP may change incentives and result in changes in fishing practices, such that Category C and/or D vessels begin to target herring using midwater trawl gear. If Category C and D midwater trawl vessels were excluded from these measures at this time, such changes in fishing behavior might undermine the FW 46 measures in the future. Thus, NMFS has approved FW 46 measures regarding Category C and D vessels, as proposed, because they are preventative in nature and consistent with the stated objectives of the action. However, the FW 46 requirements (including reporting requirements) only apply to vessels with Category C and D permits when fishing with midwater trawl gear in Areas 1A, 1B and/or 3. Category C or D vessels fishing with purse seine or otter trawl gear, or midwater trawl gear in Area 2, will be unaffected by this action.
Currently, the herring trips applied to the haddock catch cap are updated on a weekly basis, depending on the availability of data. NMFS intends to continue to update the haddock catch cap monitoring pages on its
The EA addressed the issue of localized haddock and other groundfish depletion by examining the presence and absence of groundfish fishing effort in an area before and after midwater trawl fishing effort in Section 8.4.2. The EA concluded that a strong relationship could not be determined, but the analysis did not support the idea that groundfish effort is displaced by midwater trawl activity, suggesting that groundfish may still be present in an area after midwater trawl activity.
Finally, it is not clear what bycatch reduction or mitigation strategies the commenter is referring to that could have been incorporated into the practicability analysis. The Council did not consider gear modifications or other reduction strategies in the development of FW 46, and it is not clear how the EA analysis could predict the extent to which any bycatch reduction or mitigation strategies would be undertaken by herring vessels in response to the cap, except to cease fishing operations in Area 3, as they did in FY 2010. The EA analysis concluded that the level of bycatch associated with the proposed action was practicable according to the National Standard Guidelines because the stock-specific caps would eliminate the remote possibility that the entire cap could be caught in the GOM haddock stock area and, thus, there would be almost no likelihood that haddock bycatch associated with the proposed action would have any impacts on the status of haddock stocks, or any effect on the population status of marine mammals or seabirds. It concluded further that the stock-specific caps will incentivize the midwater trawl fishery to reduce incidental catch and bycatch of haddock by avoiding fishing in areas and times where haddock are encountered in order to avoid an effective closure of the directed herring fishery. In addition, the increased, separate caps increased the likelihood that the herring GB quota would be harvested, providing opportunity for the herring fishery to achieve optimum yield, minimizing impacts on fishing practices and providing economic and cultural benefits.
In contrast, the EA concluded that the no action alternative, which maintained the current cap measures, was not practicable according to National Standard 9. The EA concluded that, although bycatch of haddock and other species under the current system would likely be lower than under the increased cap because the current cap would be more constraining if observer coverage levels remain high, there existed a small risk that a large portion of the shared cap could be caught in the GOM, threatening mortality targets for the GOM haddock stock. In addition, the current shared cap would have adverse effects on the economic, social, and cultural status of the herring fishery, which are mitigated under the increased stock-specific caps.
Thus, the approved measures represent a balance between allowing the herring fishery opportunity to achieve optimum yield, while providing incentives for the midwater trawl fishery to minimize haddock catch, and ensuring that haddock catch is adequately controlled and monitored.
Pursuant to section 304 (b)(1)(A) of the Magnuson-Stevens Act, the NMFS Assistant Administrator has determined that this final rule is consistent with the NE Multispecies FMP, other provisions of the Magnuson-Stevens Act, and other applicable law.
Pursuant to 5 U.S.C. 553(d)(1), the Assistant Administrator for Fisheries finds good cause to waive the 30-day delayed effectiveness provision of the APA. The Atlantic herring fishery is allocated a portion of the allowable catch of GOM and GB haddock each year, to account for incidental catch of haddock in the herring midwater trawl fleet. When this cap is reached or exceeded, all herring vessels are restricted to very low incidental possession limits for herring in a large portion of their fishing grounds in the GOM and GB, thereby effectively closing the areas to directed fishing because such low possession limits do not permit an economically viable fishing trip. In FY 2010, the catch of haddock primarily by the herring midwater trawl fleet reached approximately 81 percent of the haddock catch cap, and in October 2010, the herring midwater trawl fleet voluntarily moved to avoid fishing in areas with high haddock catch. As a result, fishing and processing operations were unnecessarily interrupted and the industry likely incurred increased operational costs. In addition, some of the GB herring TAC was not harvested, potentially resulting in lost economic yield for a large portion of the Atlantic herring fishery. This final rule implements measures in FW 46 that increase the haddock catch cap, thus reducing the risk that the cap would be constraining. If the stock-specific cap is reached, midwater trawl fishing for herring in that stock area would be restricted—unlike the current combined cap that, if reached, closes a large portion of the GOM and GB area to the entire herring fishery.
Summer and early fall are typically when herring fishery effort on GB and interactions with haddock are highest. Beginning in September, the restrictive haddock catch cap may force the herring fleet to curtail prematurely its fishing operations in Area 3 in order to avoid triggering the AMs. It is important that the revised haddock catch cap and accountability measures be implemented as soon as possible, before October 2011, in order to avert an effective early end to the herring fishing season on GB. After September 2011 these measures would have limited utility to herring fishery participants until summer 2012. Thus, delaying implementation would result in short-term adverse economic impacts to Atlantic herring vessels and associated shoreside facilities and fishing communities.
This final rule has been determined to be not significant for the purposes of Executive Order (E.O.) 12866.
This final rule does not contain policies with Federalism or “takings” implications as those terms are defined in E.O. 13132 and E.O. 12630, respectively.
A FRFA was prepared for this final rule, as required by section 604 of the Regulatory Flexibility Act (RFA). The FRFA, which includes the summary in this rule and the analyses contained in FW 46 and its accompanying EA/RIR/FRFA, describes the economic impact the measures proposed in FW 46 would have on small entities. A description of the action, why it is being considered, and the legal basis for this action are contained in FW 46 and the preamble to this rule.
No issues were raised by public comments specifically in response to the IRFA or with respect to the economic impacts of this action. Accordingly, no changes were made from the proposed rule as the result of any such comments.
Regulated entities include businesses owning vessels engaged in the Atlantic herring and NE multispecies fisheries. These measures would affect regulated entities engaged in commercial fishing for herring. Because the measures reduce the available GOM and GB haddock ABC for the groundfish fishery, vessels permitted in this fishery are potentially regulated by this action. However, because only approximately 17 percent of the haddock GOM and GB ABCs was landed in FY 2010 (and similar under-capture of available quota is expected in FY 2011-2012), it is not expected that NE multispecies permitted vessels would be affected by this action in the near-term or foreseeable future. The size standard for commercial fishing entities (NAICS code 114111) is $4 million in sales. Although multiple vessels may be owned by a single owner, available tracking of ownership is not readily available to reliably ascertain affiliated entities. Therefore, for purposes of analysis, each permitted vessel is treated as a single entity. In 2008 and 2009, one vessel exceeded $4 million in gross sales in each year, while in 2010, two vessels exceeded that threshold amount. During calendar year 2010, 86 vessels were issued a limited access herring permit. Therefore, because 2 entities operating in 2010 exceeded the gross sales threshold defining a large entity, 84 small commercial fishing entities were both regulated and potentially affected by the proposed action.
In total, six alternatives to the action implemented by this final rule were considered during the development of FW 46. Detailed descriptions of all the alternatives considered are available in the FW 46 EA (See
The economic impacts of this action on affected regulated small entities are positive and not different from economic impacts to large entities. NMFS disapproved measures as they apply to open access vessels that would have resulted in differential impacts to entities that represent a de minimus portion of the directed herring fishery. This action would have no short-term measurable economic impacts to vessels participating in the groundfish fishery, because it implements small allocations of haddock to the herring fishery that would have no effect on current groundfish revenues, based on most recent fishing activities, and only minor effects, if any, on possible future revenues, as these small allocations are unlikely to constrain the groundfish fishery or allow the herring fishery to displace groundfish effort. This action is likely to have a positive impact on large and small vessels participating in the Atlantic herring fishery, as it greatly reduces the possibility that a haddock catch cap would result in AMs that restrict the fishery to incidental catch limits throughout a large portion of the GOM and GB. This is because, unlike the no action alternative, the measures implemented by this final rule increase the haddock catch cap applicable to the herring fishery. Based on observed levels of haddock bycatch in the herring fishery and recent reductions in herring fishing effort (through greatly reduced ACLs in 2010), a 1-percent haddock catch cap is unlikely to be reached in the short-term, but provides a backstop and establishes a mechanism to estimate fleet-wide bycatch on a real-time basis. This will provide more effective controls over the bycatch of haddock in the herring fishery compared to the no action alternative. In addition, contrary to existing measures that would be maintained under the no action alternative, this action separates the GOM and GB haddock stocks and related catch, thereby reducing the overall impact of an effective directed fishery closure, if one were to occur. It also eliminates impacts on purse seine and otter trawl vessels (typically smaller fishing operations) by restricting the cap and the AM to midwater trawl vessels only. Because this action makes it more likely that the haddock catch cap will not constrain herring fishing beyond levels anticipated in the Atlantic Herring FMP, this action will not result in a decline in revenue for the herring fishery and may increase fishing opportunities for the herring mid-water trawl fleet regardless of size for several months relative to baseline conditions that would result if the no action alternative would be maintained. Opportunities to prosecute the offshore fishery (Area 3, GB) and fully harvest the herring optimum yield should be higher under the proposed action than under baseline conditions. The precise magnitude of the positive impact is uncertain, though the offshore areas (Areas 2 and 3) of the herring fishery generated approximately $17 million in gross herring revenues in calendar year 2009, and the revenues from fishing trips expected to be unconstrained due to the proposed action represent a relatively small fraction of that total.
This action and alternatives are described in detail in FW 46, which includes an EA, RIR, and FRFA (See
This final rule contains a collection-of-information requirement subject to review and approval by OMB under the PRA. The requirement for limited access vessels using midwater trawl gear to report total kept catch via daily VMS catch reports has been approved by OMB on September 6, 2011, under OMB Control Number 0648-0202. This action does not duplicate, overlap, or conflict with any other Federal rules.
This action would expand some reporting requirements implemented through FW 43 to monitor the current herring fishery haddock incidental catch cap, to include additional herring permit categories. Limited access herring permit holders fishing with midwater trawl gear in Herring Management Areas 1A, 1B, and/or 3 would be required to report total kept catch by haddock stock area via daily VMS catch reports. The proposed Atlantic herring regulatory amendment would require daily VMS catch reporting by limited access herring vessels for quota monitoring purposes, and the burden to the public of those catch report submissions has been analyzed in that regulatory amendment (76 FR 34947; June 15, 2011). This action would modify that proposed report to add two additional fields and thereby increase the cost per submission for limited access vessels that fish with midwater trawl gear in the GOM or on GB. Based on historic participation in the herring midwater trawl fishery, this change is expected to increase the total annual burden to the public for herring VMS catch reporting by $160 to $2,482, or $26 per entity. This action would also expand the requirements for Category A and B vessels to notify the Northeast Fishery Observer Program by phone of their intent to take a trip, and to submit a pre-landing hail to enforcement via VMS, to additional permit categories when fishing with midwater trawl gear in the GOM or on GB. However, no Category C or D vessels have reported landing herring or mackerel using midwater trawl gear in the GOM or GB. Thus, based on historic participation in the herring midwater trawl fishery, this action would not be expected to change the reporting burden associated with these requirements. In addition, applying the requirement to submit a CA I Midwater Trawl Codend Release Affidavit to additional permit categories is not expected to change the reporting burden associated with this affidavit, based on historic participation in the CA I herring fishery.
Public reporting burden for these requirements includes the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information.
Section 212 of the Small Business Regulatory Enforcement Fairness Act of 1966 states that, for each rule or group of related rules for which an agency is required to prepare a FRFA, the agency shall publish one or more guides to assist small entities in complying with the rule, and shall designate such publications as “small entity compliance guides.” The agency shall
Fisheries, Fishing, Reporting and recordkeeping requirements.
For the reasons stated in the preamble, 50 CFR part 648 is amended as follows:
16 U.S.C. 1801
(l)
(2)
(i)
(ii)
3. In § 648.14, revise paragraphs (k)(1)(i)(D); (r)(1)(vi)(A), (B), and (C); (r)(1)(vii)(E); (r)(1)(viii)(B); and (r)(2)(i) through (v); and add paragraphs (r)(1)(vi)(E) and (F) to read as follows:
(k) * * *
(1) * * *
(i) * * *
(D) Any haddock, and up to 100 lb (45 kg) of other regulated NE. multispecies other than haddock, were harvested by a vessel issued an All Areas Limited Access Herring Permit and/or an Area 2 and 3 Limited Access Herring Permit on a declared herring trip, regardless of gear or area fished, or a vessel issued a Limited Access Incidental Catch Herring Permit and/or an Open Access Herring Permit that fished with midwater trawl gear, pursuant to the requirements in § 648.80(d) and (e), and such fish are not sold for human consumption.
(r) * * *
(1) * * *
(vi) * * *
(A) For the purposes of observer deployment, fail to notify NMFS at least 72 hr prior to departing on a declared herring trip with a vessel issued an All Areas Limited Access Herring Permit and/or an Area 2 and 3 Limited Access Herring Permit and fishing with midwater trawl or purse seine gear, or on a trip with a vessel issued a Limited Access Incidental Catch Herring Permit and/or an Open Access Herring Permit that is fishing with midwater trawl gear in Management Areas 1A, 1B, and/or 3, as defined in § 648.200(f)(1) and (3), pursuant to the requirements in § 648.80(d) and (e).
(B) Possess, land, transfer, receive, sell, purchase, trade, or barter; or attempt to transfer, receive, sell, purchase, trade, or barter, or sell more than 2,000 lb (907 kg) of Atlantic herring per trip taken from the Herring GOM Haddock Accountability Measure Area and/or the Herring GB Haddock Accountability Measure Area, defined in § 648.86(a)(3)(ii)(A)(
(C) Transit the Herring GOM Haddock Accountability Measure Area and/or the Herring GB Haddock Accountability Measure Area, defined in § 648.86(a)(3)(ii)(A)(
(E) Possess or land haddock taken from the Herring GOM Haddock Accountability Measure Area and/or the Herring GB Haddock Accountability Measure Area, defined in § 648.86(a)(3)(ii)(A)(
(F) Transit the Herring GOM Haddock Accountability Measure Area and/or the Herring GB Haddock Accountability Measure Area, defined in § 648.86(a)(3)(ii)(A)(
(vii) * * *
(E) Discard haddock at sea that has been brought on deck, or pumped into the hold, of a vessel issued an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit fishing on a declared herring trip, regardless of gear or area fished, or on a trip with a vessel issued a Limited Access Incidental Catch Herring Permit and/or an Open Access Herring Permit fishing with midwater trawl gear, pursuant to the requirements in § 648.80(d) and (e).
(viii) * * *
(B) Fail to notify the NMFS Office of Law Enforcement of the time and date of landing via VMS at least 6 hr prior to landing herring at the end of a declared herring trip, if a vessel has an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit and is fishing with either midwater trawl or purse seine gear, or a Limited Access Incidental Catch Herring Permit and is fishing with midwater trawl gear in Management Areas 1A, 1B, and/or 3, as defined in § 648.200(f)(1) and (3).
(2) * * *
(i) Sell, purchase, receive, trade, barter, or transfer haddock or other regulated NE. multispecies (cod, witch flounder, plaice, yellowtail flounder, pollock, winter flounder, windowpane flounder, redfish, white hake, and Atlantic wolffish); or attempt to sell, purchase, receive, trade, barter, or transfer haddock or other regulated NE. multispecies for human consumption; if the regulated NE. multispecies are landed by a vessel issued an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit fishing on a declared herring trip, regardless of gear or area fished, or by a vessel issued a Limited Access Incidental Catch Herring Permit and/or an Open Access Herring Permit fishing with midwater trawl gear pursuant to § 648.80(d).
(ii) Fail to comply with requirements for herring processors/dealers that handle individual fish to separate out, and retain, for at least 12 hr, all haddock offloaded from a vessel issued an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit that fished on a declared herring trip regardless of gear or area fished, or by a vessel issued a Limited Access Incidental Catch Herring Permit and/or an Open Access Herring Permit that fished with midwater trawl gear pursuant to § 648.80(d).
(iii) Sell, purchase, receive, trade, barter, or transfer; or attempt to sell, purchase, receive, trade, barter, or transfer; to another person, any haddock or other regulated NE. multispecies (cod, witch flounder, plaice, yellowtail flounder, pollock, winter flounder, windowpane flounder, redfish, white hake, and Atlantic wolffish) separated out from a herring catch offloaded from a vessel issued an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit that fished on a declared herring trip regardless of gear or area fished, or by a vessel issued a Limited Access Incidental Catch Herring Permit and/or an Open Access Herring Permit that fished with midwater trawl gear pursuant to § 648.80(d).
(iv) While operating as an at-sea herring processor, fail to comply with requirements to separate out and retain all haddock offloaded from a vessel issued an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit that fished on a declared herring trip regardless of gear or area fished, or by a vessel issued a Limited Access Incidental Catch Herring Permit and/or an Open Access Herring Permit that fished with midwater trawl gear pursuant to § 648.80(d).
(v) Fish with midwater trawl gear in Closed Area I, as specified at § 648.81(a), without a NMFS approved observer onboard, if the vessel has been issued an Atlantic herring permit.
(d)
(e)
(d) * * *
(4) The vessel does not fish for, possess or land NE. multispecies, except that a vessel issued an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit and fishing on a declared herring trip, regardless of gear or area fished, or a vessel issued a Limited Access Incidental Catch Herring Permit and/or an Open Access Herring Permit and fishing with midwater trawl gear pursuant to paragraph (d) of this section, may possess and land haddock
(5) To fish for herring under this exemption, a vessel issued an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit fishing on a declared herring trip, or a vessel issued a Limited Access Incidental Catch Herring Permit and/or an Open Access Herring Permit fishing with midwater trawl gear in Management Areas 1A, 1B, and/or 3, as defined in § 648.200(f)(1) and (3), must provide notice of the following information to NMFS at least 72 hr prior to beginning any trip into these areas for the purposes of observer deployment: Vessel name; contact name for coordination of observer deployment; telephone number for contact; the date, time, and port of departure; and whether the vessel intends to engage in fishing in Closed Area I, as defined in § 648.81(a), at any point in the trip; and
(6) A vessel issued an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit fishing on a declared herring trip with midwater trawl gear, or a vessel issued a Limited Access Incidental Catch Herring Permit and fishing with midwater trawl gear in Management Areas 1A, 1B, and/or 3, as defined at § 648.200(f)(1) and (3), must notify NMFS Office of Law Enforcement through VMS of the time and place of offloading at least 6 hr prior to crossing the VMS demarcation line on their return trip to port, or, for a vessel that has not fished seaward of the VMS demarcation line, at least 6 hr prior to landing. The Regional Administrator may adjust the prior notification minimum time through publication of a notice in the
(7)
(ii) No vessel issued a Federal Atlantic herring permit and fishing with midwater trawl gear, when fishing any part of a midwater trawl tow in Closed Area I, may release fish from the codend of the net, transfer fish to another vessel that is not carrying a NMFS-approved observer (
(e) * * *
(4) The vessel does not fish for, possess, or land NE. multispecies, except that vessels that have an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit fishing on a declared herring trip may possess and land haddock or other regulated species consistent with possession restrictions in § 648.86(a)(3) and (k), respectively. Such haddock or other regulated multispecies may not be sold, purchased, received, traded, bartered, or transferred, or attempted to be sold, purchased, received, traded, bartered, or transferred for, or intended for, human consumption. Haddock or other regulated species that are separated out from the herring catch pursuant to § 648.15(d) may not be sold, purchased, received, traded, bartered, or transferred, or attempted to be sold, purchased, received, traded, bartered, or transferred for any purpose. A vessel issued an All Areas Limited Access Herring Permit and/or an Areas 2 and 3 Limited Access Herring Permit may not discard haddock that has been brought on the deck or pumped into the hold;
(d)
(a) * * *
(3) * * *
(i)
(ii) * * *
(A) * * *
(
(
(
(
(k)
(a) * * *
(4) * * *
(iii) * * *
(D)
(5) * * *
(iii)
(a) * * *
(2) If NMFS determines that the GOM and/or GB incidental catch cap for
Agricultural Marketing Service, USDA.
Proposed rule and referendum order.
This rule proposes four amendments to Marketing Agreement and Order No. 983 (order), which regulates the handling of pistachios grown in California, Arizona, and New Mexico, and provides growers with the opportunity to vote in a referendum to determine if they favor the changes. The amendments are based on proposals by the Administrative Committee for Pistachios (Committee), which is responsible for local administration of the order. The amendments would provide authority to establish aflatoxin and quality regulations for pistachios shipped to export markets, including authority to establish different regulations for different markets. These amendments are intended to provide authority to ensure uniform and consistent aflatoxin and quality regulations in the domestic and various export markets.
The referendum will be conducted from October 3 through October 14, 2011. The representative period for the purpose of the referendum is September 1, 2010, through August 31, 2011.
Martin Engeler, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA; 2202 Monterey Street, Fresno, California 93721;
Small businesses may request information on complying with this regulation by contacting Laurel May, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA, 1400 Independence Avenue, SW., STOP 0237, Washington, DC 20250-0237;
This rule is issued under Marketing Agreement and Order No. 983, both as amended (7 CFR part 983), regulating the handling of pistachios produced in California, Arizona, and New Mexico, hereinafter referred to as the “order.” The order is effective under the Agricultural Marketing Agreement Act of 1937, as amended (7 U.S.C. 601-674), hereinafter referred to as the “Act.” The applicable rules of practice and procedure governing the formulation of marketing agreements and orders (7 CFR part 900) authorize amendment of the order through this informal rulemaking action.
The Department of Agriculture (USDA) is issuing this rule in conformance with Executive Order 12866.
This proposal has been reviewed under Executive Order 12988, Civil Justice Reform. This rule is not intended to have retroactive effect.
The Act provides that administrative proceedings must be exhausted before parties may file suit in court. Under section 608c(15)(A) of the Act, any handler subject to an order may file with USDA a petition stating that the order, any provision of the order, or any obligation imposed in connection with the order is not in accordance with law and request a modification of the order or to be exempted therefrom. A handler is afforded the opportunity for a hearing on the petition. After the hearing, USDA would rule on the petition. The Act provides that the district court of the United States in any district in which the handler is an inhabitant, or has his or her principal place of business, has jurisdiction to review USDA's ruling on the petition, provided an action is filed not later than 20 days after the date of the entry of the ruling.
Section 1504 of the Food, Conservation, and Energy Act of 2008 (2008 Farm Bill) (Pub. L. 110-246) made changes to section 18c(17) of the Act, which in turn required the addition of supplemental rules of practice to 7 CFR part 900 (73 FR 49307; August, 21, 2008). The changes to section 18c(17) of the Act and additional supplemental rules of practice authorize the use of informal rulemaking (5 U.S.C. 553) to amend federal fruit, vegetable, and nut marketing agreements and orders if certain criteria are met.
AMS has considered the nature and complexity of the proposed amendments, the potential regulatory and economic impacts on affected entities, and other relevant matters, and has determined that amending the order as proposed by the committee could appropriately be accomplished through informal rulemaking.
The proposed amendments were unanimously recommended by the Committee following deliberations at a public meeting on July 9, 2010. A proposed rule soliciting comments on the proposed amendments was issued on June 5, 2011, and published in the
The Committee's proposed amendments would: (1) Provide authority to establish aflatoxin sampling, analysis, and inspection requirements for shipments of pistachios to export markets, including authority to establish different regulations for different markets; (2) Provide authority to establish quality and inspection requirements for shipments of pistachios to export markets, including authority to establish different regulations for different markets; (3) Change a related section of the order concerning substandard pistachios to conform to the proposed addition of export authority; and (4) Correct an erroneous cross-reference to another section of the order.
Section 983.50 of the order provides authority to establish aflatoxin sampling, analysis, and inspection requirements applicable to pistachios shipped for domestic human consumption. Section 983.150 of the order's administrative rules and regulations establishes such requirements. These regulations prohibit the shipment of pistachios for domestic human consumption unless they have been sampled and tested according to specific procedures and protocols, and certified that they do not contain traces of aflatoxin exceeding a tolerance level of 15 parts per billion (ppb). The aflatoxin regulations under the order are intended to help assure consumers of a good quality product and to reduce the risk of potential aflatoxin contamination. While authority exists to establish aflatoxin regulations for domestic shipments of pistachios, no such authority exists under the order for export shipments. This proposed amendment would add authority to establish aflatoxin regulations for shipments of pistachios to export markets.
When the order was promulgated in 2004, a State of California marketing agreement was in effect that provided aflatoxin testing and certification for export shipments to designated markets. Under that program, handlers tested and certified export shipments according to the methods and protocols acceptable to the export destination. Thus, the authority to regulate export shipments was not included in the order to avoid duplication. The State program served the needs of the industry for several years, but was terminated in 2010. Although handlers continue to test and certify product prior to shipping into export markets, there is currently no program in place to establish uniform and consistent procedures.
The export market is becoming increasingly important to the U.S. pistachio industry to market its continually increasing production. Pistachio acreage and production in the U.S. has been increasing steadily since the crop became commercially significant in the 1970's. This upward trend has continued since the order was promulgated, and is expected to continue into the foreseeable future. According to information reported by the Committee, in 2004 pistachio bearing acreage in California was 93,000 acres and non-bearing acreage was 24,733 acres, for a total of 117,773 acres. In 2010, bearing acreage was 137,102 acres and non-bearing acreage was 78,234, for a total of 215,336 acres. This represents an 83 percent increase in total acreage in just six years. The increased plantings are a response to the growing demand for U.S. pistachios, especially in export markets. A review of Committee shipment data indicates a substantial increase in shipments to export markets has occurred in recent years. Export shipments of open inshell pistachios increased from 95,761,666 pounds in the 2004-05 shipping season to 192,436,136 pounds in the 2009-10 season. Exports represented approximately 63 percent of total U.S. pistachio shipments during the 2009-10 season, underscoring the importance of the export market to the industry.
In view of the new plantings of pistachios as represented by the non-bearing acreage data, it is readily apparent that the production of U.S. pistachios will increase significantly in coming years. Successful marketing of the crop in the future will be dependent not only on sustaining current markets, but increasing the global demand to absorb the increased production. In order to accomplish this, it is important to reduce the risk of an aflatoxin incident involving U.S. pistachios.
In the mid-1990's, heightened consumer concern about aflatoxin occurred in Europe which resulted in a significant drop in pistachio consumption in those markets. Issues involving other commodities have also occurred in recent years, with adverse impacts. The pistachio industry thus believes it would be prudent to avail itself of an additional tool that could be used to reduce the risk of potential aflatoxin incidence in U.S. pistachios and the associated negative impacts.
Although pistachios destined for export markets are currently being tested and certified based on the requirements in those markets and customer's needs, there is currently no program in place with government oversight to ensure all handlers are following specific established protocols and procedures. Adding authority to the order to allow issuance of rules and regulations for aflatoxin testing and certification for export shipments would provide a mechanism to establish uniform and consistent aflatoxin sampling, analysis, and inspection requirements for shipments of domestically produced pistachios to export markets. A program with consistent and uniform procedures, with Federal oversight, would help instill confidence with foreign customers and government officials that the U.S. pistachio industry is committed to providing a good quality product to its markets that match or exceed the standards of the importing country.
The intent of the proposed amendments authorizing aflatoxin regulation for exports is to provide an additional tool under the order to aid in successful marketing of future crops.
The various export markets to which pistachios are shipped often have different requirements, such as allowable aflatoxin tolerance levels. Thus, the Committee also recommended adding authority to the order to establish different aflatoxin regulations for different markets. The proposed amendment would therefore authorize different regulations for different markets.
If the order is amended to include authority to establish aflatoxin regulations for shipments to export markets, specific regulations would need to be added to the order's rules and regulations through the informal rulemaking process. If the industry chooses to pursue such regulations, the Committee would meet to consider and analyze the available information in developing any recommendation to AMS. Any recommendation of the Committee concerning potential aflatoxin regulations would require a unanimous vote of 12 Committee members or alternate members acting in their stead according to the voting requirements in § 983.43 of the order.
For the reasons stated above, it is proposed that § 983.50, Aflatoxin regulations, be amended to authorize the Committee, with approval of the Secretary, to establish aflatoxin sampling, analysis, and inspection requirements for pistachios to be shipped for human consumption in export markets. It is also proposed that § 983.50 of the order be amended to authorize the Committee, with approval of the Secretary, to establish different aflatoxin requirements for different markets.
Section 983.51 of the order provides authority for the Committee, with approval of the Secretary, to establish quality and inspection requirements for pistachios shipped for domestic human consumption. There are currently no such requirements in effect under the order.
When the order was promulgated in 2004, specific requirements pertaining to quality levels were contained in the provisions of the order. These provisions were in effect from 2004 through 2007. In December 2007, the requirements were suspended because they were no longer meeting the
Applying similar logic, the Committee recommended at its July 2010 meeting to amend the broad quality authority under the order to include the authority to establish requirements for export shipments, in addition to domestic shipments. No quality regulations are currently being contemplated by the industry; however, the Committee believes it would be prudent to expand the current authority for quality regulations to include export shipments. Adding broad authority for quality regulations for exports would provide flexibility in the order by increasing the industry's ability to respond to quality issues related to exports, if they arise. Exports are becoming an increasingly important market for the industry and currently account for the marketing of nearly two-thirds of domestically produced pistachios.
The Committee also recommended adding authority to the order to establish different quality requirements for different markets. Similar to the discussion under Proposal Number 1, different markets to which pistachios are shipped may have different quality requirements or concerns. The proposed amendment would therefore authorize different quality regulations for different markets. This would provide additional flexibility to the order to address different market needs.
If the order is amended to include authority to establish quality regulations for shipments to export markets, specific regulations would need to be added to the order's rules and regulations through the informal rulemaking process. If the industry chooses to pursue such regulations, the Committee would meet to consider and analyze the available information in developing a recommendation to AMS. Any recommendation of the Committee concerning potential quality regulations would require a unanimous vote of 12 Committee members or alternate members acting in their stead according to the voting requirements in § 983.43 of the order.
For the reasons stated above, it is proposed that § 983.51, Quality regulations, be amended to authorize the Committee, with approval of the Secretary, to establish quality and inspection requirements for pistachios to be shipped for human consumption in export markets. It is also proposed that § 983.51 of the order be amended to authorize the Committee, with approval of the Secretary, to establish different quality requirements for different markets.
Section 983.57 of the order provides authority to establish reporting and disposition procedures for pistachios that do not meet aflatoxin or quality requirements (substandard product) to ensure they are not shipped for domestic human consumption. Since the order currently authorizes regulation of the domestic market only, § 983.57 does not reference the utilization of reporting and disposition procedures to ensure that substandard pistachios are not shipped to other markets besides the domestic market. Therefore, if Proposal Numbers 1 and 2 are adopted to include authority to regulate other markets, a conforming change should be made to § 983.57 to reference the utilization of reporting and disposition procedures to ensure substandard pistachios are not shipped to any market for which regulations exist.
It is therefore proposed that § 983.57, Substandard pistachios, be amended to authorize reporting and disposition procedures for substandard pistachios to ensure they are not shipped for human consumption in any market for which aflatoxin and/or quality requirements exist pursuant to § 983.50 and/or § 983.51.
Section 983.53 of the order pertains to aflatoxin testing of minimal quantities of pistachios and provides, in part, that lots of pistachios exceeding the maximum tolerance level for aflatoxin may be tested again after being reworked as specified in § 983.50. The reference to § 983.50 is incorrect. The correct section, which pertains to rework procedures, is § 983.52. This proposed amendment recommended by the Committee would correct the erroneous reference.
It is therefore proposed to amend § 983.53 by removing the reference to § 983.50 in paragraph (a)(2) and replacing it with the correct reference to § 983.52.
Pursuant to requirements set forth in the Regulatory Flexibility Act (RFA) (5 U.S.C. 601-612), the Agricultural Marketing Service (AMS) has considered the economic impact of this action on small entities. Accordingly, AMS has prepared this final regulatory flexibility analysis.
The purpose of the RFA is to fit regulatory actions to the scale of business subject to such actions in order that small businesses will not be unduly or disproportionately burdened. Marketing orders issued pursuant to the Act, and rules issued thereunder, are unique in that they are brought about through group action of essentially small entities acting on their own behalf.
There are approximately 850 producers and 29 handlers of pistachios in the production area encompassing California, Arizona, and New Mexico. The Small Business Administration (SBA) (13 CFR 121.201) defines small agricultural producers as those having annual receipts of less than $750,000, and small agricultural service firms are defined as those having annual receipts of less than $7,000,000.
Based on Committee data, it is estimated that over 70 percent of the handlers ship less than $7,000,000 worth of pistachios and would thus be considered small business under the SBA definition. It is also estimated that over 80 percent of the growers in the production area produce less than $750,000 worth of pistachios and would thus be considered small businesses under the SBA definition.
The amendments proposed by the Committee would provide authority to establish aflatoxin sampling, analysis, and inspection requirements for shipments of pistachios to export markets, including authority to establish different regulations for different markets; provide authority to establish quality and inspection requirements for shipments of pistachios to export markets, including authority to establish different regulations for different markets; change a related section of the order concerning substandard pistachios to conform to the proposed addition of export authority; and correct an erroneous cross-reference to another section of the order.
These proposed amendments were unanimously recommended at a public meeting of the Committee held on July 10, 2010. None of the proposed amendments would have an immediate impact on handlers or producers if they are approved because they would not establish any requirements or
Under § 983.50 of the order and § 983.150 of the administrative rules and regulations, sampling, analysis, and inspection of pistachios for aflatoxin is required prior to shipment to domestic markets. Specific procedures and requirements for handlers to follow are prescribed. It is anticipated that any requirements recommended for export shipments would be similar to those in effect for domestic shipments. Thus, the associated costs would be similar.
The costs of complying with aflatoxin regulations can be broken into three basic elements: sampling of the product, the market value of the product samples that are used in testing, and the cost of the aflatoxin analysis performed by laboratories. These costs can vary among handlers depending on their particular operations. In recognition of this, the Committee provided estimates of the various cost elements for purposes of this discussion.
The cost of drawing samples from lots is estimated to range from $50.00 to $75.00 per lot. The variation in this cost can be attributed to factors such as the type of inspection program utilized by handlers. For purposes of this evaluation a cost factor of $70.00 per lot is utilized. The cost of the product used in sampling and testing varies depending upon the market price for pistachios. For purposes of this evaluation a value of $3.00 per pound as estimated by the Committee is utilized. At $3.00 per pound and a 44-pound sample, the cost of product used in sampling is $132.00 per lot. Laboratory costs for analyzing aflatoxin content are estimated to be $100.00 per test; with two tests per lot, the cost is $200.00 per lot.
Pistachio lots tested for aflatoxin can vary in size, but for purposes of this evaluation, a lot size of 50,000 pounds is used as that is a reasonable representative size for a typical handler operation. Applying the above cost estimates to a lot size of 50,000 pounds results in the following cost estimates on a per pound basis:
When compared to the market price for pistachios, the direct costs associated with an aflatoxin program are proportionately small. Utilizing a market price of $3.00 per pound as used in the above cost estimates, the costs of aflatoxin sampling and testing represent 0.27 percent of the market price. Even if the market price for pistachios was $1.00 per pound, the aflatoxin sampling and testing costs would be well below one percent of the price.
Most handlers who shipped pistachios to export markets in the past were signatories to a state marketing agreement that required aflatoxin sampling and analysis. That program was terminated in 2010. Since then, most handlers reportedly conduct aflatoxin testing and certification on export shipments to satisfy the requirements of the various markets. Therefore, the costs discussed above are already being borne by handlers.
While difficult to quantify, one of the primary benefits of an aflatoxin program is the reduced risk of a potential food incident. For example, in the late 1990's, high aflatoxin levels were detected in pistachios in European markets. This led to a 60 percent decrease in pistachio imports in Europe, and it took several years for the market to return to more normal levels. The U.S was not dominant in the European market at that time, but in recent years, Europe has become an increasingly significant market for U.S. pistachios. Regardless of the location of the market, this example demonstrates the devastating effect a food quality or food safety issue can have on the marketing of a product.
Another benefit of an aflatoxin testing program is the resulting reduction in the incidence of rejected shipments at their destination. Many countries test product prior to allowing its importation. Product that does not meet the importing country's standards can be rejected and returned to the shipper. It is estimated that the cost of handling or returning a rejected lot is between $12,000 and $15,000 per lot. Product that has been tested prior to shipment based on the requirements of its market destination is less likely to be rejected and would not incur the associated costs.
Avoiding a disruption in the marketing of pistachios in export markets is important in maintaining the viability of the industry. Shipments of open inshell pistachios increased dramatically in recent years; from 95,761,666 pounds in the 2004-05 shipping season to 192,436,136 pounds in the 2009-10 season, according to Committee data. Exports represented approximately 63 percent of total U.S. pistachio shipments during the 2009-10 season. According to statistics reported by the Committee, total acreage increased from 117,773 acres in 2004 to 215,336 acres in 2010, representing an 83 percent increase. Much of this acreage is non-bearing and will come into production in the near future. These statistics demonstrate that domestic production of pistachios will continue to increase in the future, and export markets must be maintained to accommodate the increased supplies.
Expanding order authority to include establishing aflatoxin requirements applicable to export shipments will provide an additional tool to aid in the marketing of pistachios covered under the order. In the event the authority is implemented, the potential costs associated with a mandatory aflatoxin program for exports are expected to be more than offset by the potential benefits discussed above.
An analysis of the potential costs of adding authority to the order to establish quality regulations is not possible because no quality regulations are currently in effect under the order, and none are being contemplated. Quality regulations were in effect for domestic shipments from 2004 through 2007, but were suspended because they were no longer meeting the industry's needs. However, the order still contains broad authority for domestic quality regulations and the industry may desire to reinstate them if circumstances warrant. As a result of the increasing importance of the export market as demonstrated above, the Committee recommended adding authority to the order for quality regulation for export shipments in the event circumstances in the future warrant their implementation.
If such authority is added to the order, a unanimous action of the Committee would be required to recommend the establishment of any export quality regulations. In addition, informal rulemaking would be required for implementation, and an analysis of the potential costs and benefits would be conducted during that process.
The remaining proposed amendments are administrative in nature and would have no economic impact on growers or handlers. One of the proposed amendments would add conforming language to another section of the order if other amendments are approved, and another proposed amendment would correct an incorrect section reference in the order.
Alternatives to these proposals include making no changes at this time. However, the Committee believes it would be beneficial to have the means necessary to apply regulations to the export markets if circumstances warrant.
In accordance with the Paperwork Reduction Act of 1995 (44 U.S.C. chapter 35), the order's information collection requirements have been previously approved by the Office of Management and Budget (OMB) and assigned OMB No. 0581-0215, “Pistachios Grown in California”. No changes in those requirements as a result of this proceeding are anticipated. Should any changes become necessary, they would be submitted to OMB for approval.
As with all Federal marketing order programs, reports and forms are periodically reviewed to reduce information requirements and duplication by industry and public sector agencies.
In addition, USDA has not identified any relevant Federal rules that duplicate, overlap, or conflict with this rule.
AMS is committed to complying with the E-Government Act, to promote the use of the Internet and other information technologies to provide increased opportunities for citizen access to Government information and services, and for other purposes.
The Committee's meeting, at which these proposals were discussed, was widely publicized throughout the pistachio industry. All interested persons were invited to attend the meeting and encouraged to participate in Committee deliberations on all issues. Like all Committee meetings, the meeting was public, and all entities, both large and small, were encouraged to express their views on these proposals.
A proposed rule concerning this action was published in the
One comment was received in response to the proposal. The comment, submitted on behalf of a pistachio trade association, was supportive of the proposed amendments. Accordingly, no changes have been made to the proposed amendments, based on the comment received.
A small business guide on complying with fruit, vegetable, and specialty crop marketing agreements and orders may be viewed at:
The findings and conclusions and general findings and determinations included in the proposed rule set forth in the June 13, 2011, issue of the
Annexed hereto and made a part hereof is the document entitled “Order Amending the Order Regulating the Handling of Pistachios Grown in California, Arizona, and New Mexico.” This document has been decided upon as the detailed and appropriate means of effectuating the foregoing findings and conclusions.
It is hereby directed that a referendum be conducted in accordance with the procedure for the conduct of referenda (7 CFR 900.400-900.407) to determine whether the annexed order amending the order regulating the handling of pistachios grown in California, Arizona, and New Mexico is approved by growers, as defined under the terms of the order, who during the representative period were engaged in the production of pistachios in the production area.
The representative period for the conduct of such referendum is hereby determined to be September 1, 2010 through August 31, 2011.
The agents of the Secretary to conduct such referendum are designated to be Rose M. Aguayo and Andrea Ricci, California Marketing Field Office, Marketing Order Administration Branch, Fruit and Vegetable Programs, AMS, USDA;
Marketing agreements, Pistachios, Reporting and recordkeeping requirements.
The findings hereinafter set forth are supplementary to the findings and determinations which were previously made in connection with the issuance of the marketing agreement and order; and all said previous findings and determinations are hereby ratified and affirmed, except insofar as such findings and determinations may be in conflict with the findings and determinations set forth herein.
1. The marketing agreement and order, as amended, and as hereby proposed to be further amended, and all of the terms and conditions thereof, would tend to effectuate the declared policy of the Act;
2. The marketing agreement and order, as amended, and as hereby proposed to be further amended, regulate the handling of pistachios grown in California, Arizona, and New Mexico in the same manner as, and are applicable only to, persons in the respective classes of commercial and industrial activity specified in the marketing agreement and order;
3. The marketing agreement and order, as amended, and as hereby proposed to be further amended, are limited in application to the smallest regional production area which is practicable, consistent with carrying out the declared policy of the Act, and the issuance of several orders applicable to subdivisions of the production area would not effectively carry out the declared policy of the Act;
4. The marketing agreement and order, as amended, and as hereby proposed to be further amended, prescribe, insofar as practicable, such different terms applicable to different parts of the production area as are necessary to give due recognition to the differences in the production and
5. All handling of pistachios produced in the production area as defined in the marketing agreement and order is in the current of interstate or foreign commerce or directly burdens, obstructs, or affects such commerce.
The provisions of the proposed marketing order amending the order contained in the proposed rule issued by the Administrator on June 5, 2011, and published in the
1. The authority citation for 7 CFR part 983 continues to read as follows:
7 U.S.C. 601-674.
2. Revise § 983.50 to read as follows:
The committee shall establish, with the approval of the Secretary, such aflatoxin sampling, analysis, and inspection requirements applicable to pistachios to be shipped for domestic human consumption as will contribute to orderly marketing or be in the public interest. The committee may also establish, with the approval of the Secretary, such requirements for pistachios to be shipped for human consumption in export markets. No handler shall ship, for human consumption in domestic, or if applicable, export markets, pistachios that exceed an aflatoxin level established by the committee and approved by the Secretary. All shipments to markets for which requirements have been established must be covered by an aflatoxin inspection certificate. The committee may, with the approval of the Secretary, establish different sampling, analysis, and inspection requirements, and different aflatoxin level requirements, for different markets.
3. Revise § 983.51 to read as follows:
For any production year, the committee may establish, with the approval of the Secretary, such quality and inspection requirements applicable to pistachios shipped for human consumption in domestic or export markets as will contribute to orderly marketing or be in the public interest. In such production year, no handler shall ship pistachios for human consumption in domestic, or if applicable, export markets unless they meet the applicable requirements as evidenced by certification acceptable to the committee. The committee may, with the approval of the Secretary, establish different quality and inspection requirements for different markets.
4. Amend § 983.53 by removing the reference to “§ 983.50” and adding in its place “§ 983.52” in paragraph (a)(2).
5. Revise § 983.57 to read as follows:
The committee shall, with the approval of the Secretary, establish such reporting and disposition procedures as it deems necessary to ensure that pistachios which do not meet aflatoxin and quality requirements are not shipped for human consumption in those markets for which such requirements exist pursuant to § 983.50 and § 983.51.
Nuclear Regulatory Commission.
Reopening of comment period.
On July 8, 2011, the U.S. Nuclear Regulatory Commission (NRC) published a draft Regulatory Issue Summary (RIS) pertaining to NRC regulation of military operational Radium-226 for a 60-day public comment period that ended on September 6, 2011. The NRC has decided to reopen the comment period for an additional 75 days.
The comment period for the publication July 8, 2011 at 76 FR 40282, has been reopened and now closes on November 29, 2011. Comments received after this date will be considered if it is practical to do so, but the NRC is able to assure consideration only for comments received on or before this date.
Please include Docket ID NRC-2011-0146 in the subject line of your comments. For additional instructions on submitting comments and instructions on accessing documents related to this action, see “Submitting comments and Accessing Information:” in the
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Robert L. Johnson, Office of Federal and State Materials and Environmental Management Programs, Division of Waste Management and Environmental Protection, U.S. Nuclear Regulatory Commission, Washington, DC 20555-0001, telephone: 301-415-7282, e-mail:
Comments submitted in writing or in electronic form will be posted on the NRC Web site and on the Federal rulemaking Web site,
The NRC requests that any party soliciting or aggregating comments received from other persons for submission to the NRC inform those persons that the NRC will not edit their comments to remove any identifying or contact information, and therefore, they should not include any information in their comments that they do not want publically disclosed.
You can access publicly available documents related to this notice using the following methods:
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On October 1, 2007 (72 FR 55864), the NRC published a final rule that amended its regulations to include jurisdiction over discrete sources of radium-226, accelerator-produced radioactive materials, and discrete sources of naturally occurring radioactive material, as required by the Energy Policy Act of 2005, which was signed into law on August 8, 2005 (NARM Rule). In order to clarify those discrete sources of radium-226 under military control that are subject to NRC regulation, as interpreted in the statement of considerations to the NARM Rule, on July 8, 2011 (76 FR 40282), the NRC published for public comment the proposed draft RIS 2011-XX; NRC Regulation of Military Operational Radium-226. On August 29, 2011, the NRC received a request from the U.S. Department of Defense (DoD) for a meeting with the NRC staff and an extension of the comment period. In response to the request for DoD, the NRC has decided to reopen the comment period for an additional 75 days. The NRC staff will schedule the public meeting for a date that has yet to be determined. Notice of this public meeting will be provided through the NRC's Web site.
For the Nuclear Regulatory Commission.
Department of Energy, Office of Energy Efficiency and Renewable Energy.
Notice of open meeting.
This document announces an open meeting of the Negotiated Rulemaking Working Group for Low-Voltage Dry-Type Distribution Transformers (hereafter “LV Group”). The LV Group is a working group within the Appliance Standards Subcommittee of the Efficiency and Renewables Advisory Committee (ERAC). The purpose of the LV Group is to discuss and, if possible, reach consensus on a proposed rule for regulating the energy efficiency of distribution transformers, as authorized by the Energy Policy Conservation Act (EPCA) of 1975, as amended, 42 U.S.C. 6313(a)(6)(C) and 6317(a). A separate Working Group on Liquid-Immersed and Medium-Voltage Dry Type Distribution Transformers is being convened to discuss and, if possible, reach consensus on a proposed rule for regulating the energy efficiency of medium-voltage and liquid-immersed transformers, as authorized by the Energy Policy Conservation Act (EPCA) of 1975, as amended, 42 U.S.C. 6313(a)(6)(C) and 6317(a) [FR Doc. 2011-19263].
Wednesday, September 28, 2011, 9 a.m.-5 p.m.
Department of Energy, Forrestal Building, 1000 Independence Avenue, SW., Room 8E-089, Washington, DC 20585. Please arrive at least 30 minutes early for building entry requirements. Please view the Public Participation section for more information.
John Cymbalsky, U.S. Department of Energy, Office of Building Technologies (EE-2J), 1000 Independence Avenue, SW., Washington, DC 20585-0121. Telephone: (202) 287-1692. E-mail:
A regulatory negotiation will enable DOE to engage in direct and sustained dialog with informed, interested, and affected parties when drafting the proposed regulation that is then presented to the public for comment. Gaining this early understanding of all parties' perspectives allows DOE to address key issues at an earlier stage of the process, thereby allowing more time for an iterative process to resolve issues. A rule drafted by negotiation with informed and affected parties is more likely to maximize benefits while minimizing unnecessary costs than one conceived or drafted without the opportunity for sustained dialog among interested and expert parties. DOE anticipates that there will be a need for fewer substantive changes to a proposed rule developed under a regulatory negotiation process prior to the publication of a final rule.
To the maximum extent possible, consistent with the legal obligations of the Department, DOE will use the consensus of the advisory committee or subcommittee as the basis for the rule the Department proposes for public notice and comment.
• Tim Ballo (Earthjustice).
• Scott Beck (Lakeview Metals).
• Eric Petersen (AK Steel).
• Gary Fernstrom (PG&E).
• Andrew DeLaski (ASAP).
• Robin Roy (NRDC).
• Steve Nadel (ACEEE).
• Eduardo Robles (Eaton).
• Robert Greeson (Federal Pacific).
• Vijay Tendulkar (ONYX Power).
• Chad Kennedy (Schneider).
• John Caskey (NEMA).
• Millure David (Metglas).
• John Cymbalsky (U.S. Department of Energy).
• Mark Stoering (Xcel Energy).
Anyone attending the meeting will be required to present government-issued identification. Foreign nationals will be required, per DOE security protocol, to complete a questionnaire, no later than, one week prior to the meeting, Thursday, September 22, 2011.
Participation in the meeting is not a prerequisite for submission of written comments. ERAC invites written comments from all interested parties. If you would like to file a written statement with the committee, you may do so either by submitting a hard or electronic copy before or after the meeting. Electronic copy of written statements should be e-mailed to
Office of the Secretary (OST), Department of Transportation (DOT).
Notice of proposed rulemaking (NPRM).
The Department of Transportation is proposing to amend its existing airline smoking rule to explicitly ban the use of electronic cigarettes on all aircraft in scheduled passenger interstate, intrastate and foreign air transportation. The Department is taking this action because of the increased promotion of electronic cigarettes and the potential health and passenger comfort concerns that they pose in an aircraft. The Department is also considering whether to extend the ban on smoking (including electronic cigarettes) to charter flights of air carriers (
Comments should be filed by November 14, 2011. Late-filed comments will be considered to the extent possible.
You may file comments identified by the docket number DOT-OST-2011-0044 by any of the following methods:
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Laura E. Jennings, Trial Attorney, Office of the Assistant General Counsel for Aviation Enforcement and Proceedings, U.S. Department of Transportation, 1200 New Jersey Ave., SE., Washington, DC 20590, 202-366-9342 (phone), 202-366-7152 (fax),
Throughout this proposed rule, we use the terms “air carrier” and “foreign air carrier” as defined in 49 U.S.C. 40102, in which “air carrier” is a citizen of the United States undertaking to provide air transportation, and a “foreign air carrier” is a person, not a citizen of the United States, undertaking to provide foreign air transportation.
The current statutory ban on smoking in scheduled interstate, intrastate, and foreign air transportation derives from the Wendell H. Ford Aviation Investment and Reform Act for the 21st Century or “AIR-21” (Pub. L. 106-181), which was signed into law on April 5, 2000. It included section 708, “Prohibitions Against Smoking on Scheduled Flights,” and was codified as 49 U.S.C. 41706. Section 41706 states:
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(b)
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On June 9, 2000, the Department amended 14 CFR part 252, titled Smoking Aboard Aircraft, to implement section 41706.
Electronic cigarettes were introduced into the market in recent years. Because of the increasing promotion and availability of electronic cigarettes the issue has been raised as to whether the statutory ban on smoking in section 41706 and existing regulatory prohibition on the smoking of tobacco products in part 252 apply to electronic cigarettes. The Department views the statutory and regulatory ban on smoking to be sufficiently broad to include the use of electronic cigarettes. While we view the statutory ban on smoking in section 41706 to cover electronic cigarettes as the statutory authority for this NPRM, we are, nonetheless, not solely relying on section 41706, which prohibits smoking aboard aircraft, but also another statute, as was true when we amended Part 252 to implement section 41706. This statute, 49 U.S.C. 41702, mandates that an air carrier shall provide safe and adequate interstate air transportation. We invite all interested persons to comment.
This NPRM proposes to amend part 252 to define smoking as the smoking of tobacco products or use of electronic cigarettes that are designed to deliver nicotine or other substances to a user in the form of a vapor. The Department does not intend for the definition to include the use of a device such as a nebulizer that delivers a medically beneficial substance to a user in the form of a vapor. Typically electronic cigarettes, also called “e-cigarettes,” are designed to look like traditional cigarettes. E-cigarettes are sometimes also made to look like cigars and pipes, and even everyday products such as pens.
Studies show thousands of people use electronic cigarettes daily, and the products generate an estimated $100 million annually in sales. Some are marketed as being permissible in places where cigarette use is prohibited. Through Congressional correspondence, anecdotal evidence, and online sources, including blogs, the Department has been made aware that some airline passengers have used or have attempted to use electronic cigarettes on board commercial flights. This NPRM proposes an explicit ban on the use of electronic cigarettes that would apply to all forms of the products, including but not limited to: Electronic cigars, pipes, and devices designed to look like everyday products such as pens and USB memory sticks.
The Department views its current regulatory ban on smoking of tobacco products on passenger flights to be sufficiently broad to include the use of electronic cigarettes. The recent decision by the U.S. Court of Appeals for the DC Circuit,
The Department is proposing in this NPRM to explicitly ban the use of electronic cigarettes on aircraft as there has been some confusion over whether the Department's ban on smoking of tobacco products includes a ban on use of electronic cigarettes. We see no reason to treat electronic cigarettes any differently than traditional cigarettes. The purpose behind the statutory ban on smoking aboard aircraft and the regulatory ban in part 252 on smoking tobacco products was to improve air quality within the aircraft, reduce the risk of adverse health effects on passengers and crewmembers, and enhance aviation safety and passenger comfort. Electronic cigarettes are generally designed to look like and to be used in the same manner as conventional cigarettes. Although a vapor, rather than smoke, is produced, the products require an inhalation and exhalation similar to smoking cigarettes. We are unaware of sufficient studies on the health impact on third parties from these vapors to conclude that they would not negatively impact the air quality within the aircraft and/or increase the risk of adverse health effects on passengers and crewmembers.
Each e-cigarette consists of three parts: The replaceable cartridge, which most often contains liquid nicotine but may contain other chemicals, the atomizer or heating element, and the battery and electronics. See
Some electronic cigarette companies have claimed that their products are safe because they reportedly do not contain carcinogens or tar or produce second-hand smoke, as there is no combustion in their use. According to these arguments, while the vapor looks and feels, and may taste, like smoke produced by burning traditional tobacco products, its chemistry differs from the smoke produced from burning conventional tobacco products. The principal liquid ingredient is propylene glycol, which is widely used as a moistening food additive and an aid to vaporization. However, some research, conducted on non-asthmatic people, has shown that exposure to propylene glycol mist from artificial smoke generators may cause acute ocular and upper airway irritation, and in a few cases people reacted with cough and slight airway obstruction. See G Wieslander, D Norbäck, and T Lindgren, “Experimental exposure to propylene glycol mist in aviation emergency training: Acute ocular and respiratory effects,”
Researchers at the University of California, Riverside, published a study on December 7, 2010, in which they evaluated five electronic cigarette brands. See Anna Trtchounian & Prue Talbot, “Electronic nicotine delivery systems: Is there a need for regulation?”
Numerous public health experts also have voiced concerns over electronic cigarettes. Reacting to the University of California, Riverside, study, a research administrator from the University of California Tobacco-Related Disease Research Program stated, “More research on e-cigarettes is crucially needed to protect the health of e-cigarette users and even those who do not use e-cigarettes. Contrary to the claims of the manufacturers and marketers of e-cigarettes being `safe,' in fact nothing is known about the toxicity of the vapors generated by these e-cigarettes.” See ScienceDaily.com, “Electronic Cigarettes are Unsafe and Pose Health Risks, Study Finds,
We note that Amtrak has banned the use of electronic smoking devices on trains and in any area where smoking is prohibited, the Air Force Surgeon General issued a memorandum highlighting the safety concerns regarding electronic cigarettes and placed them in the same category as tobacco products, and the U.S. Navy has banned them below decks in submarines. Moreover, several states have taken steps to ban either the sale or use of electronic cigarettes, in the absence of federal regulation.
The purpose behind the statutory ban on smoking aboard aircraft and the regulatory ban in Part 252 on smoking tobacco products was to improve air quality within the aircraft, reduce the risk of adverse health effects on passengers and crewmembers, and enhance aviation safety and passenger comfort. The object of the proposed rule is to prevent introduction of a new potential source of contamination to the cabin environment that could potentially endanger the welfare of nonsmokers who are now protected from all such exposure. Consistent with this underlying purpose, we are proposing this NPRM. There is a lack of scientific data and knowledge with respect to the ingredients in electronic cigarettes. The quantity and toxicity of exhaled vapors have not been studied. Releasing a vapor that may contain harmful substances or respiratory irritants in a confined space, especially to those who are at a higher risk, is contrary to the purpose and intent of the statutory and regulatory ban on smoking aboard aircraft.
In light of the unknown health risks with the use of electronic cigarettes by individuals who “smoke” them or the people around them and the growing availability and use of electronic cigarettes, the Department is proposing this amendment to Part 252 to explicitly ban the use of electronic cigarettes aboard aircraft. The Department seeks comments on the following: (1) Whether the definition of “smoking” in the proposed rule text is too broad in that it may unintentionally include otherwise permissible medical devices that produce a vapor; (2) concerns over, and benefits of, the proposal to clarify the prohibition in Part 252 to explicitly cover electronic cigarettes; and (3) any other information or data that are relevant to the Department's decision.
The Department is also considering whether to extend the ban on smoking (including electronic cigarettes) to charter flights of air carriers and foreign air carriers between points in the U.S. and between the U.S. and any foreign point with aircraft that have a designed seating capacity of 19 or more passenger seats. Under the current part 252, air carriers operating single-entity charters may permit smoking throughout the aircraft (
We note that we are not addressing in this rulemaking any other safety-related issues that may exist with the use of electronic cigarettes aboard aircraft (
This action has been determined to be significant under Executive Order 12866 and the Department of Transportation's Regulatory Policies and Procedures. It has been reviewed by the Office of Management and Budget under that Order. We find that the benefits of the proposal exceed its costs.
In 2009, there were a total of 73 U.S. carriers and 101 foreign air carriers providing service covered by the present rule. In total, these carriers operated 782 million passenger departures. These passengers and carriers and their employees have all benefited from protection by the existing rule against the injurious effects of secondhand smoke. They have also benefited from inclusion of e-cigarettes in the smoking prohibition to the extent that exhaled vapors may be harmful (whether or not including components of nicotine). The proposed rule would offer incremental benefits in limiting potential pollution resulting from the mistaken supposition that e-cigarettes are not covered by the current no-smoking rules. As the market for these devices expands, the number of misinformed passengers and the difficulty of reducing confusion over the use of these devices would likely grow without this rulemaking.
Costs of enforcement should be negligible at this time. By making the prohibition explicit and public, the Department will relieve carriers of much of the burden of policing violations and explaining the rule to passengers who mistakenly believe that use of e-cigarettes is allowed. The present system for notifying passengers of the prohibition should need little modification, although notice that e-cigarettes are not exempt might be appropriate at certain times, either orally or otherwise. While a small fraction of passengers may suffer from nicotine withdrawal, they would still have access to alternative methods of nicotine replacement such as gum or patches that do not release contaminants into the environment.
Pursuant to section 605 of the Regulatory Flexibility Act (RFA), 5 U.S.C. 605(b), as amended by the Small Business Regulatory Enforcement and Fairness Act of 1996 (SBREFA), DOT certifies that this rulemaking will not have a significant economic impact on a substantial number of small entities. The NPRM would impose no new duties or obligations on small entities.
This action will not have a substantial direct effect on the States, on the relationship between the national Government and the States, or on the distribution of power and responsibilities among the various levels of government, and therefore will not have federalism implications.
This notice has been analyzed in accordance with the principles and criteria contained in Executive Order 13084 (“Consultation and Coordination with Indian Tribal Governments”). Because the provision on which we are seeking comment would not significantly or uniquely affect the communities of the Indian tribal governments or impose substantial direct compliance costs on them, the funding and consultation requirements of Executive Order 13084 do not apply.
The Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501
The Department has determined that the requirements of Title II of the Unfunded Mandates Reform Act of 1995 do not apply to this rulemaking.
Air carriers, Aircraft, Consumer protection, Foreign air carriers, smoking.
For the reasons set forth in the preamble, the Department proposes to amend 14 CFR part 252 as follows:
1. The authority citation for 14 CFR Part 252 continues to read as follows:
Pub. L. 101-164; 49 U.S.C. 40102, 40109, 40113, 41701, 41702, 41706, as amended by section 708 of Pub. L 106-181, 41711, and 46301.
2. Section 252.1 is revised to read as follows:
This part implements a ban on smoking on air carrier and foreign air carrier flights in scheduled intrastate, interstate and foreign air transportation. It also addresses smoking on charter flights. Nothing in this part shall be deemed to require air carriers or foreign air carriers to permit smoking aboard aircraft.
3. Section 252.3 is revised to read as follows:
As used in this part:
4. Section 252.4 is added to read as follows:
Air carriers shall prohibit smoking on all scheduled passenger flights.
5. Section 252.8 is revised to read as follows:
The restrictions on smoking described in §§ 252.4 through 252.7 shall apply to all locations within the aircraft.
Bureau of Prisons, Justice.
Proposed rule.
In this document, the Bureau of Prisons (Bureau) proposes to remove from regulations and/or modify two types of progress reports: Transfer reports and triennial reports.
Comments are due by November 14, 2011.
Submit comments to the Rules Unit, Office of General Counsel, Bureau of Prisons, 320 First Street, NW., Washington, DC 20534. You may view an electronic version of this rule at
Sarah Qureshi, Office of General Counsel, Bureau of Prisons, phone (202) 307-2105.
Please note that all comments received are considered part of the public record and made available for public inspection online at
If you want to submit personal identifying information (such as your name, address,
If you want to submit confidential business information as part of your comment but do not want it to be posted online, you must include the phrase “Confidential Business Information” in the first paragraph of your comment. You must also prominently identify confidential business information to be redacted within the comment. If a comment has so much confidential business information that it cannot be effectively redacted, all or part of that comment may not be posted on
Personal identifying information identified and located as set forth above will be placed in the agency's public docket file, but not posted online. Confidential business information identified and located as set forth above will not be placed in the public docket file. If you wish to inspect the agency's public docket file in person by appointment, please see the “For Additional Information” paragraph.
In this document, the Bureau proposes to remove from regulations and/or modify two types of progress reports: Transfer reports and triennial reports.
Section 524.41, entitled “Types of progress reports,” lists several types of progress reports prepared for non-Bureau entities, such as for parole hearings, pre-release, final (prepared 90 days before an inmate's release to a term of supervision), and for other reasons (such as upon court request or a clemency review). The current regulations also identify two types of progress reports that were primarily intended for internal Bureau purposes: Those prepared when inmates transfer to community confinement or another institution, and those prepared triennially if not more frequently done for any other reason.
Current Bureau practice and advances in technology have obviated the need to prepare a specific paper report when an inmate is transferred between Bureau facilities. When an inmate is transferred, all pertinent information regarding the progress of an inmate being transferred has already been updated in the Bureau's computer system, which staff may access at all Bureau facilities and in community confinement. It is, therefore, unnecessary for a separate and specific progress report to be prepared by staff at the transferring Bureau facility for staff at the receiving Bureau facility, when receiving facility staff can easily access this information themselves.
However, when an inmate is transferring outside the Bureau, to a state facility, non-Bureau community confinement, or other non-Bureau facility, staff at that facility may not have access to the Bureau's computer system. Therefore, it would be necessary for Bureau staff to prepare a transfer report detailing an inmate's progress in the Bureau facility for the benefit of staff at the non-Bureau facility.
Before the development of this internal Bureau computer information network, triennial reports were a necessary tool used to provide staff with specific inmate information. As explained above, however, current Bureau practice and advances in technology have obviated the need to prepare a specific progress report every 36 months, because all information regarding an inmate's progress is continually updated in the Bureau's computer system, which staff may access at all Bureau facilities.
This rule falls within a category of actions that the Office of Management
This regulation will not have substantial direct effects on the States, on the relationship between the national government and the States, or on distribution of power and responsibilities among the various levels of government. Therefore, under Executive Order 13132, we determine that this rule does not have sufficient federalism implications to warrant the preparation of a Federalism Assessment.
The Director of the Bureau of Prisons, under the Regulatory Flexibility Act (5 U.S.C. 605(b)), reviewed this regulation and by approving it certifies that it will not have a significant economic impact upon a substantial number of small entities for the following reasons: This rule pertains to the correctional management of offenders committed to the custody of the Attorney General or the Director of the Bureau of Prisons, and its economic impact is limited to the Bureau's appropriated funds.
This rule will not result in the expenditure by State, local and tribal governments, in the aggregate, or by the private sector, of $100,000,000 or more in any one year, and it will not significantly or uniquely affect small governments. Therefore, no actions were deemed necessary under the provisions of the Unfunded Mandates Reform Act of 1995.
This rule is not a major rule as defined by section 804 of the Small Business Regulatory Enforcement Fairness Act of 1996. This rule will not result in an annual effect on the economy of $100,000,000 or more; a major increase in costs or prices; or significant adverse effects on competition, employment, investment, productivity, innovation, or on the ability of United States-based companies to compete with foreign-based companies in domestic and export markets.
Prisoners.
Under rulemaking authority vested in the Attorney General in 5 U.S.C. 552(a) and delegated to the Director, Bureau of Prisons, we propose to amend 28 CFR part 524 as set forth below.
1. The authority citation for 28 CFR part 524 continues to read as follows:
5 U.S.C. 301; 18 U.S.C. 3521-3528, 3621, 3622, 3624, 4001, 4042, 4046, 4081, 4082 (Repealed in part as to offenses committed on or after November 1, 1987), 5006-5024 (Repealed October 12, 1984 as to offenses committed after that date), 5039; 21 U.S.C. 848; 28 U.S.C. 509, 510.
2. In § 524.41, remove paragraphs (d) and (e), redesignate paragraph (f) as paragraph (e), and add a new paragraph (d) to read as follows:
(d)
Equal Employment Opportunity Commission.
Proposed rule: Cancellation of hearing.
Notice is hereby given that the Commission is cancelling the public hearing on the above proposed modifications of its recordkeeping and reporting provisions under title VII, the ADA, and GINA. (76 FR 31892, June 2, 2011). No requests to present oral testimony at a hearing concerning the proposed rule were received from the public. Further, the Commission received only one public comment in response to the June 2 notice, and the commenter expressed support for the proposed changes. Therefore, it will not be necessary to hold the hearing.
Thomas J. Schlageter, Assistant Legal Counsel, (202) 663-4668, or Erin N. Norris, Senior Attorney, (202) 663-4876, Office of Legal Counsel, 131 M Street, NE., Washington, DC 20507.
For the Commission.
Environmental Protection Agency (EPA).
Proposed rule.
EPA proposes to approve the State Implementation Plan (SIP) revision submitted by the State of West Virginia for the purpose of amending the 8-hour ozone maintenance plan for the Charleston, Huntington, Parkersburg, Weirton, and Wheeling 8-hour ozone maintenance areas. This revision amends the maintenance plans' 2009 and 2018 motor vehicle emissions budgets (MVEBs) by reallocating a portion of the plans' safety margins which results in an increase in the MVEBs. In the Final Rules section of this
Comments must be received in writing by October 17, 2011.
Submit your comments, identified by Docket ID Number EPA-R03-OAR-2007-0511 by one of the following methods:
A.
B.
C.
D.
Martin Kotsch, (215) 814-3335, or by e-mail at
For further information, please see the information provided in the direct final action, with the same title, that is located in the Rules and Regulations section of this
National Aeronautics and Space Administration.
Proposed rule.
NASA proposes to revise the NASA FAR Supplement (NFS) to update the Award Fee for Service Contracts clause (NFS 1852.216-76) to clarify that the amount of award fee held in reserve, if any, shall not exceed $100,000 for the contract. The purpose of this reserve is to protect the Government's interests relative to an orderly and timely closeout of the contract. In addition, the Award Fee for End Item Contracts clause (NFS 1852.216-77) is being updated to add language similar to that contained in the Award Fee for Service Contracts clause to allow the contracting officer to withhold fee payments, at a not to exceed amount of $100,000 for the contract, to protect the Government's interests relative to an orderly and timely closeout of the contract.
Interested parties should submit comments to NASA at the address below on or before November 14, 2011 to be considered in formulation of the final rule.
Interested parties may submit comments to include any comments relative to the cost associated with complying with this requirement, identified by RIN number 2700-AD70, via the Federal eRulemaking Portal:
Bill Roets, NASA, Office of Procurement, Contract Management Division (Suite 5G86); (202) 358-4483; e-mail:
In accordance with FAR 16.406(e), the NFS clause 1852.216-76 was created and required for all solicitations and contracts when an award fee contract was contemplated and the contract deliverable was the performance of a service. This clause delineates the award fee evaluation and payment process that will be followed in the contract. NASA is updating this clause to clarify that the amount of withheld award fee shall not exceed $100,000 for the contract revising paragraph (d) of 1852.216-76. As currently written, the clause specifies a not to exceed of 15 percent of the contract's potential award fee, and on large multi-million dollar procurements, this reserve could total millions of dollars which would be excessive for the intended purpose of this reserve. By capping this reserve at $100,000, NASA will set the appropriate maximum dollar amount for this potential reserve and will align this clause with similar language in FAR clauses 52.216-8, Fixed-Fee, and 52.216-10, Incentive Fee.
Similar language relative to withholding a reserve amount of fee, not to exceed $100,000, to protect the Government's interests relative to an orderly and timely closeout of the contract, is also being added to the
Executive Orders (E.O.s) 12866 and 13563 direct agencies to assess all costs and benefits of available regulatory alternatives and, if regulation is necessary, to select regulatory approaches that maximize net benefits (including potential economic, environmental, public health and safety effects, distributive impacts, and equity). E.O. 13563 emphasizes the importance of quantifying both costs and benefits, of reducing costs, of harmonizing rules, and of promoting flexibility. This rule is not a major rule under 5 U.S.C. 804.
NASA certifies that this proposed rule will not have a significant economic impact on a substantial number of small entities within the meaning of the Regulatory Flexibility Act, 5 U.S.C. 601
The Paperwork Reduction Act (Pub. L. 104-13) is not applicable because the NFS changes do not impose information collection requirements that require the approval of the Office of Management and Budget under 44 U.S.C. 3501,
Government procurement.
Accordingly, 48 CFR part 1852 is proposed to be amended as follows:
1. The authority citation for 48 CFR part 1852 continues to read as follows:
42 U.S.C. 2455(a), 2473(c)(1).
2. Section 1852.216-76 is revised to read as follows:
As prescribed in 1816.406-70(a), insert the following clause:
(a) The contractor can earn award fee from a minimum of zero dollars to the maximum stated in NASA FAR Supplement clause 1852.216-85, “Estimated Cost and Award Fee” in this contract.
(b) Beginning 6* months after the effective date of this contract, the Government shall evaluate the Contractor's performance every 6* months to determine the amount of award fee earned by the contractor during the period. The Contractor may submit a self-evaluation of performance for each evaluation period under consideration. These self-evaluations will be considered by the Government in its evaluation. The Government's Fee Determination Official (FDO) will determine the award fee amounts based on the Contractor's performance in accordance with
(c) The Government will advise the Contractor in writing of the evaluation results. The
(d) The Contracting Officer may direct the withholding of earned award fee payments until a reserve is set aside in an amount that the Contracting Officer considers necessary to protect the Government's interest relative to an orderly and timely closeout of the contract. This reserve shall not exceed 15 percent of the contract's total potential award fee or $100,000, whichever is less.
(e) The amount of award fee which can be awarded in each evaluation period is limited to the amounts set forth at
(f)(1) Provisional award fee payments
(2) Provisional award fee payments will be superseded by the final award fee evaluation for that period. If provisional payments exceed the final evaluation score, the Contractor will either credit the next payment voucher for the amount of such overpayment or refund the difference to the Government, as directed by the Contracting Officer.
(3) If the Contracting Officer determines that the Contractor will not achieve a level of performance commensurate with the provisional rate, payment of provisional award fee will be discontinued or reduced in such amounts as the Contracting Officer deems appropriate. The Contracting Officer will notify the Contractor in writing if it is determined that such discontinuance or reduction is appropriate.
(4) Provisional award fee payments
(g) Award fee determinations are unilateral decisions made solely at the discretion of the Government.
* [A period of time greater or lesser than 6 months may be substituted in accordance with 1816.405-272(a).]
3. Section 1852.216-77 is revised to read as follows:
As prescribed in 1816.406-70(b), insert the following clause:
(a) The contractor can earn award fee, or base fee, if any, from a minimum of zero dollars to the maximum stated in NASA FAR Supplement clause 1852.216-85, “Estimated Cost and Award Fee” in this contract. All award fee evaluations, with the exception of the last evaluation, will be interim evaluations. At the last evaluation, which is final, the Contractor's performance for the entire contract will be evaluated to determine total earned award fee. No award fee or base fee will be paid to the Contractor if the final award fee evaluation is “poor/unsatisfactory.”
(b) Beginning 6* months after the effective date of this contract, the Government will evaluate the Contractor's interim performance every 6* months to monitor Contractor performance prior to contract completion and to provide feedback to the Contractor. The evaluation will be performed in accordance with
(c)(1) Base fee, if applicable, will be paid in
(2) Interim award fee payments will be made to the Contractor based on each interim evaluation. The amount of the interim award fee payment is limited to the lesser of the interim evaluation score or 80 percent of the fee allocated to that period
(3) Provisional award fee payments will
(4) All interim (and provisional, if applicable) fee payments will be superseded by the fee determination made in the final award fee evaluation. The Government will then pay the Contractor, or the Contractor will refund to the Government the difference between the final award fee determination and the cumulative interim (and provisional, if applicable) fee payments. If the final award fee evaluation is “poor/unsatisfactory,” any base fee paid will be refunded to the Government.
(5) Payment of base fee, if applicable, will be made based on submission of an invoice by the Contractor. Payment of award fee will be made by the
(d) The Contracting Officer may direct the withholding of interim award fee payments until a reserve is set aside in an amount that the Contracting Officer considers necessary to protect the Government's interest relative to an orderly and timely closeout of the contract. This reserve shall not exceed 15 percent of the contracts total potential award fee or $100,000, whichever is less.
(e) Award fee determinations are unilateral decisions made solely at the discretion of the Government.
* [A period of time greater or lesser than 6 months may be substituted in accordance with 1816.405-272(a).]
The Department of Agriculture has submitted the following information collection requirement(s) to OMB for review and clearance under the Paperwork Reduction Act of 1995, Public Law 104-13. Comments regarding (a) Whether the collection of information is necessary for the proper performance of the functions of the agency, including whether the information will have practical utility; (b) the accuracy of the agency's estimate of burden including the validity of the methodology and assumptions used; (c) ways to enhance the quality, utility and clarity of the information to be collected; (d) ways to 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 should be addressed to: Desk Officer for Agriculture, Office of Information and Regulatory Affairs, Office of Management and Budget (OMB),
An agency may not conduct or sponsor a collection of information unless the collection of information displays a currently valid OMB control number and the agency informs potential persons who are to respond to the collection of information that such persons are not required to respond to the collection of information unless it displays a currently valid OMB control number.
Import Administration, International Trade Administration, Department of Commerce.
On August 30, 2011, the United States Court of International Trade (“CIT”) sustained the Department of Commerce's (“the Department”) results of redetermination as applied to respondent Shandong Rongxin Import & Export Co., Ltd. (“Rongxin”) pursuant to the CIT's remand order in
Alexander Montoro or Nancy Decker, AD/CVD Operations, Office 1, Import Administration—International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC, 20230; telephone (202) 482-0238 or (202) 482-0196.
On July 13, 2009, the Department published its
Also in the
Additionally, in the
On first remand, the Department adopted a wage calculation methodology with respect to Rongxin that averaged wages across countries that are both economically comparable and significant producers of merchandise comparable to the subject merchandise.
On second remand, the Department revised its wage rate methodology to rely upon labor cost data from a single surrogate country.
In its decision in
Because there is now a final court decision with respect to Rongxin, the revised dumping margin is as follows:
In the event the CIT's ruling is not appealed or, if appealed, upheld by the CAFC, the Department will instruct U.S. Customs and Border Protection to assess antidumping duties on entries of the subject merchandise during the POR from Rongxin on the revised assessment rate calculated by the Department.
This notice is issued and published in accordance with sections 516A(e)(1), 751(a)(1), and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
On August 1, 2011, the Department of Commerce (the Department) initiated the sunset reviews of the antidumping duty orders on ball bearings and parts thereof from France, Germany, and Italy. See
Sandra Stewart at (202) 482-0768, AD/CVD Operations, Office 5, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230.
On May 15, 1989, the Department published in the
On August 1, 2011, the Department initiated the sunset reviews of the antidumping duty orders on ball bearings and parts thereof from France, Germany, and Italy pursuant to section 751(c) of the Tariff Act of 1930, as amended (the Act). See
The products covered by the orders are ball bearings and parts thereof. These products include all antifriction bearings that employ balls as the rolling element. Imports of these products are classified under the following categories: antifriction balls, ball bearings with integral shafts, ball bearings (including radial ball bearings) and parts thereof, and housed or mounted ball bearing units and parts thereof.
Imports of these products are classified under the following Harmonized Tariff Schedule of the United States (HTSUS) subheadings: 3926.90.45, 4016.93.10, 4016.93.50, 6909.19.50.10, 8414.90.41.75, 8431.20.00, 8431.39.00.10, 8482.10.10, 8482.10.50, 8482.80.00, 8482.91.00, 8482.99.05, 8482.99.35, 8482.99.25.80, 8482.99.65.95, 8483.20.40, 8483.20.80, 8483.30.40, 8483.30.80, 8483.50.90, 8483.90.20, 8483.90.30, 8483.90.70, 8708.50.50, 8708.60.50, 8708.60.80, 8708.93.30, 8708.93.60.00, 8708.99.06, 8708.99.31.00, 8708.99.40.00, 8708.99.49.60, 8708.99.58, 8708.99.80.15, 8708.99.80.80, 8803.10.00, 8803.20.00, 8803.30.00, 8803.90.30, 8803.90.90, 8708.30.50.90, 8708.40.75.70, 8708.40.75.80, 8708.50.79.00, 8708.50.89.00, 8708.50.91.50, 8708.50.99.00, 8708.70.60.60, 8708.80.65.90, 8708.93.75.00, 8708.94.75, 8708.95.20.00, 8708.99.55.00, 8708.99.68, and 8708.99.81.80.
Although the HTSUS item numbers above are provided for convenience and customs purposes, the written descriptions of the scope of the orders remain dispositive.
The size or precision grade of a bearing does not influence whether the bearing is covered by one of the orders. The orders cover all the subject bearings and parts thereof (inner race, outer race, cage, rollers, balls, seals, shields,
For a list of scope determinations which pertain to the orders, see the “Memorandum to Laurie Parkhill” regarding scope determinations for the 2009/2010 administrative reviews dated April 14, 2011, which is on file in the Central Records Unit (CRU) of the main Commerce building, room 7046, in the General Issues record (A-100-001).
Pursuant to section 751(c)(3)(A) of the Act and 19 CFR 351.218(d)(1)(iii)(B)(3), if no domestic interested party files a notice of intent to participate, the Department shall issue a final determination revoking the order within 90 days of the initiation of the review. Because no domestic interested party filed a timely notice of intent to participate in the sunset reviews, the Department finds that no domestic interested party is participating in the sunset reviews. Therefore, we are revoking the antidumping duty orders on ball bearings and parts thereof from France, Germany, and Italy. The effective date of revocation is September 15, 2011, the fifth anniversary of the continuation of the antidumping duty orders. See
Pursuant to section 751(c)(3)(A) of the Act and 19 CFR 351.222(i)(2)(i), the Department intends to issue instructions to U.S. Customs and Border Protection to terminate the suspension of liquidation of entries of the merchandise subject to the orders which were entered, or withdrawn from warehouse, for consumption on or after September 15, 2011. Entries of subject merchandise prior to September, 15, 2011, will continue to be subject to the suspension of liquidation and requirements for deposits of estimated antidumping duties. The Department will conduct administrative reviews of the orders with respect to subject merchandise entered prior to the effective date of revocation in response to appropriately filed requests for review.
These final results of the five-year (sunset) reviews and notice are published in accordance with sections 751(c) and 777(i)(1) of the Act.
Import Administration, International Trade Administration, Department of Commerce.
On June 28, 2011, the Department of Commerce (the Department) published a notice of initiation of an administrative review of the antidumping duty order on circular welded carbon steel pipes and tubes from Taiwan. The review covers eight firms. Based on a withdrawal of the requests for review of certain companies from United States Steel Corporation (Petitioner), we are now rescinding this administrative review with respect to six of those firms.
Steve Bezirganian or Robert James, AD/CVD Operations, Office 7, Import Administration, International Trade Administration, U.S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230; telephone: (202) 482-1131 or (202) 482-0649, respectively.
On June 28, 2011, the Department published in the
On August 8, 2011, the Petitioner withdrew its request for an administrative review for the following six companies: (1) E United Group; (2) Yieh Corp.; (3) Yieh Hsing Enterprise Co., Ltd.; (4) Far East Machinery Co. Ltd.; (5) Kao Hsing Chang Iron & Steel Corp. (also known as Kao Hsiung Chang Iron & Steel Corp.); and (6) Tension Steel Industries Co. Ltd.
The applicable regulation, 19 CFR 351.213(d)(1), states that if a party that requested an administrative review withdraws the request within 90 days of the publication of the notice of initiation of the requested review, the Secretary will rescind the review. The Petitioner withdrew its review request with respect to six companies within the 90-day deadline, in accordance with 19 CFR 351.213(d)(1).
Therefore, in accordance with section 351.213(d)(1) of the Department's regulations, we are partially rescinding this review with respect to the following six companies: (1) E United Group; (2) Yieh Corp.; (3) Yieh Hsing Enterprise Co., Ltd.; (4) Far East Machinery Co. Ltd.; (5) Kao Hsing Chang Iron & Steel Corp. (also known as Kao Hsiung Chang Iron & Steel Corp.); and (6) Tension Steel Industries Co. Ltd. This review will continue with respect to Yieh Phui Enterprise Co., Ltd. and Chung Hung Steel Corp.
The Department will instruct U.S. Customs and Border Protection (CBP) to assess antidumping duties on all appropriate entries. For the companies for which this review is rescinded, antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(1)(i). The Department intends to issue appropriate assessment instructions directly to CBP 15 days after publication of this notice.
This notice serves as a final reminder to importers for whom this review is being rescinded of their responsibility under 19 CFR 351.402(f)(2) to file a certificate regarding the reimbursement of antidumping duties prior to liquidation of the relevant entries during this review period. Failure to comply with this requirement could result in the Secretary's presumption that reimbursement of the antidumping duties occurred and the subsequent assessment of double antidumping duties.
This notice also serves as a reminder to parties subject to administrative protective orders (APO) of their responsibility concerning the return or destruction of proprietary information disclosed under APO in accordance with 19 CFR 351.305, which continues to govern business proprietary information in this segment of the proceeding. Timely written notification of the return/destruction of APO
This notice is issued and published in accordance with section 777(i)(1) of the Tariff Act of 1930, as amended, and 19 CFR 351.213(d)(4).
Import Administration, International Trade Administration, Department of Commerce.
September 15, 2011.
On May 27, 2011, the U.S. Department of Commerce (“the Department”) published a notice of initiation of an administrative review of the antidumping duty order on magnesium metal from the People's Republic of China (“PRC”).
Laurel LaCivita, AD/CVD Operations, Office 8, Import Administration, International Trade Administration, U. S. Department of Commerce, 14th Street and Constitution Avenue, NW., Washington, DC 20230;
On April 1, 2011, the Department published a notice of opportunity to request an administrative review of the antidumping duty order on magnesium metal from the PRC for the period April 1, 2010 through March 31, 2011.
On June 20, 2011, the Department placed on the record information obtained in response to the Department's query to CBP concerning imports into the United States of subject merchandise during the POR.
On July 14, 2011, the Department notified interested parties of its intent to rescind this administrative review and gave parties until July 21, 2010, to provide comments. We did not receive any comments.
The product covered by this antidumping duty order is magnesium metal from the PRC, which includes primary and secondary alloy magnesium metal, regardless of chemistry, raw material source, form, shape, or size. Magnesium is a metal or alloy containing by weight primarily the element magnesium. Primary magnesium is produced by decomposing raw materials into magnesium metal. Secondary magnesium is produced by recycling magnesium-based scrap into magnesium metal. The magnesium covered by this order includes blends of primary and secondary magnesium.
The subject merchandise includes the following alloy magnesium metal products made from primary and/or secondary magnesium including, without limitation, magnesium cast into ingots, slabs, rounds, billets, and other shapes; magnesium ground, chipped, crushed, or machined into rasping, granules, turnings, chips, powder, briquettes, and other shapes; and products that contain 50 percent or greater, but less than 99.8 percent, magnesium, by weight, and that have been entered into the United States as conforming to an “ASTM Specification for Magnesium Alloy”
The scope of this order excludes: (1) All forms of pure magnesium, including chemical combinations of magnesium and other material(s) in which the pure magnesium content is 50 percent or greater, but less than 99.8 percent, by weight, that do not conform to an “ASTM Specification for Magnesium Alloy”
The merchandise subject to this order is classifiable under items 8104.19.00, and 8104.30.00 of the Harmonized Tariff Schedule of the United States (“HTSUS”). Although the HTSUS items are provided for convenience and customs purposes, the written description of the merchandise is dispositive.
Based upon the certifications and the evidence on the record, the Department finds TMI's claim of no shipments of subject merchandise to the United States during the POR to be substantiated. Pursuant to 19 CFR 351.213(d)(3), the Department may rescind an administrative review, in whole or with respect to a particular exporter or producer, if the Secretary concludes that, during the period covered by the review, there were no entries, exports, or sales of the subject merchandise. Therefore, the Department is rescinding this review in accordance with 19 CFR 351.213(d)(3). The Department intends to instruct CBP fifteen days after the publication of this notice to liquidate such entries. Antidumping duties shall be assessed at rates equal to the cash deposit of estimated antidumping duties required at the time of entry, or withdrawal from warehouse, for consumption, in accordance with 19 CFR 351.212(c)(2).
We are issuing and publishing this notice in accordance with sections 751(a)(1) and 777(i) of the Act and 19 CFR 351.213(d)(4).
Office of Ocean and Coastal Resource Management (OCRM), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of public hearing; request for public comments.
This notice provides information on a public hearing to be held by NOAA and the Illinois Department of Natural Resources (IDNR) in Chicago, Illinois. The hearing involves the scope and content of a Draft Environmental Impact Statement (DEIS) prepared by NOAA's Office of Ocean and Coastal Resource Management. The DEIS assesses the environmental impacts associated with approval of the Illinois Coastal Management Program (ICMP). This notice also announces the opening of the public comment period on the DEIS.
The agency must receive comments on or before October 31, 2011.
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Diana Olinger, Coastal Program Specialist, National Oceanic and Atmospheric Administration, OCRM/CPD, N/ORM3, Station 11204, 1305 East-West Highway, Silver Spring, MD 20910, telephone (301) 563-1149, facsimile (301) 713-4367, e-mail
Illinois has submitted a coastal management program to NOAA for approval under the Coastal Zone Management Act (CZMA), 16 U.S.C. 1451,
Upon finding that a state program has satisfied the requirements of the CZMA, NOAA is required to prepare a DEIS. The Council on Environmental Quality regulations to implement the National Environmental Policy Act (NEPA), 40 CFR parts 1500-1508, apply to the preparation of the DEIS. Specifically, section 1506.6 requires agencies to provide public notice of NEPA-related hearings and the availability of environmental documents. This notice is part of NOAA's effort to comply with those regulations.
Copies of the DEIS are available by any one of the following methods:
• Contact Diana Olinger, NOAA Coastal Program Specialist, at the address indicated above;
• OCRM's Web site:
• Illinois Department of Natural Resource's Web site:
National Marine Fisheries Service (NMFS), National Oceanic and Atmospheric Administration (NOAA), Commerce.
Council to convene a public meeting.
The Gulf of Mexico Fishery Management Council will convene a meeting of the Ad Hoc Reef Fish Limited Access Privilege Program (LAPP) Advisory Panel.
The meeting will be 9 a.m. to 5 p.m. on Thursday, October 6, 2011.
The meeting will be held at the Gulf of Mexico Fishery Management Council, 2203 North Lois Avenue, Suite 1100, Tampa, FL 33607.
Dr. Assane Diagne, Economist; Gulf of Mexico Fishery Management Council;
The purpose of the meeting is to discuss management issues and potential pilot programs for the charter for-hire sector in the Gulf of Mexico. Issues to be discussed include the design, implementation, monitoring, review, and, evaluation of charter for-hire pilot programs.
Copies of the agenda and other related materials can be obtained by calling (813) 348-1630 or can be downloaded from the Council's ftp site,
Although other non-emergency issues not on the agenda may come before the Ad Hoc Reef Fish Limited Access Privilege Program Advisory Panel for discussion, in accordance with the Magnuson-Stevens Fishery Conservation and Management Act, those issues may not be the subject of formal action during this meeting. Actions of the Ad Hoc Reef Fish Limited Access Privilege Program Advisory Panel will be restricted to those issues specifically identified in the agenda and any issues arising after publication of this notice that require emergency action under Section 305(c) of the Magnuson-Stevens Fishery Conservation and Management 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 Kathy Pereira at the Council (see
National Oceanic and Atmospheric Administration, Commerce.
Notice of public meeting.
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the Sea Grant Advisory Board (Board). Board members will discuss and provide advice on the National Sea Grant College Program in the areas of program evaluation, strategic planning, education and extension, science and technology programs, and other matters as described in the agenda found on the National Sea Grant College Program Web site at
The announced meeting is scheduled 8 a.m.-4:30 p.m. E.S.T. Wednesday, September 28 and 8 a.m.-4 p.m. E.S.T. Thursday, September 29, 2011.
The meeting will be held at University of Rhode Island's Graduate School of Oceanography, Narragansett Bay Campus, 215 South Ferry Road, Ocean Technology Center, Narragansett, RI 02882.
Ms. Elizabeth Ban, Designated Federal Officer, National Sea Grant College Program, National Oceanic and Atmospheric Administration, 1315 East-West Highway, Room 11843, Silver Spring, Maryland 20910, (301) 734-1082.
The Board, which consists of a balanced representation from academia, industry, state government and citizens groups, was established in 1976 by Section 209 of the Sea Grant Improvement Act (Pub. L. 94-461, 33 U.S.C. 1128). The Board advises the Secretary of Commerce and the Director of the National Sea Grant College Program with respect to operations under the Act, and such other matters as the Secretary refers to them for review and advice.
The agenda for this meeting can be found at
Office of Oceanic and Atmospheric Research (OAR), National Oceanic and Atmospheric Administration (NOAA), Department of Commerce (DOC).
Notice of public meeting.
This notice sets forth the schedule and proposed agenda of a forthcoming meeting of the NOAA Science Advisory Board. The members will discuss and provide advice on issues outlined in the section on Matters to be Considered.
The meeting is scheduled for: Friday, September 30, from 3:15-5:15 p.m. Eastern Daylight Time.
Conference call. Public access is available at: NOAA, SSMC 3, Room 11836, 1315 East-West Highway, Silver Spring, Md.
Status: The meeting will be open to public participation with a 5-minute public comment period from 5:05-5:10 p.m. The SAB expects that public statements presented at its meetings will not be repetitive of previously submitted verbal or written statements. In general, each individual or group making a verbal presentation will be limited to a total time of one minute. Written comments should be received in the SAB Executive Director's Office by September 26, 2011 to provide sufficient time for SAB review. Written comments received by the SAB Executive Director after September 26, 2011, will be distributed to the SAB, but may not be reviewed prior to the meeting date.
The Science Advisory Board (SAB) was established by a Decision Memorandum dated September 25, 1997, and is the only Federal Advisory Committee with responsibility to advise the Under Secretary of Commerce for Oceans and Atmosphere on strategies for research, education, and application of science to operations and information services. SAB activities and advice provide necessary input to ensure that National Oceanic and Atmospheric Administration (NOAA) science programs are of the highest quality and provide optimal support to resource management.
Matters To Be Considered: The meeting will include the following topics: (1) Final Report from the Climate and Environmental Information Services Working Groups' Climate Partnership Task Force (2) Review of new members and renewal of member terms for the Environmental Information Services Working Group (3) Terms of Reference and Proposed Members for a Satellite Task Force (4) NOAA Request for SAB Review of the NOAA Research Enterprise and (5) NOAA Request for the Ecosystem Sciences and Management Working Group to vet reviewers for the National Marine Fisheries Science Centers. For the latest agenda, please visit the SAB Web site at
Dr. Cynthia Decker, Executive Director, Science Advisory Board, NOAA, Rm. 11230, 1315 East-West Highway, Silver Spring, Maryland 20910. (
Consumer Product Safety Commission.
Notice of meeting.
The U.S. Consumer Product Safety Commission (“CPSC” or “Commission”) is announcing a teleconference of the Chronic Hazard Advisory Panel (CHAP) on phthalates and phthalate substitutes. The Commission appointed this CHAP to study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and child care articles, pursuant to section 108 of the Consumer Product Safety Improvement Act of 2008 (CPSIA) (Pub. L. 110-314). The CHAP will discuss its progress toward completing its analysis of potential risks from phthalates and phthalate substitutes.
The teleconference will take place from 11:30 a.m. to 1 p.m. E.D.T. (4:30 p.m. to 6 p.m. British Summer Time or 15:30 to 17:00 G.M.T.) on Tuesday, September 20, 2011. Interested members of the public may listen to the CHAP's discussion. Members of the public will not have the opportunity to ask questions, comment, or otherwise participate in the teleconference. Interested parties should contact the CPSC project manager, Michael Babich, by e-mail (
To request access to the teleconference, contact the project manager by e-mail at
Section 108 of the CPSIA permanently prohibits the sale of any “children's toy or child care article” containing more than 0.1 percent of each of three specified phthalates: Di- (2-ethylhexyl) phthalate (DEHP), dibutyl phthalate (DBP), and benzyl butyl phthalate (BBP). Section 108 of the CPSIA also prohibits, on an interim basis, the sale of any “children's toy that can be placed in a child's mouth” or “child care article” containing more than 0.1 percent of each of three additional phthalates: diisononyl phthalate (DINP), diisodecyl phthalate (DIDP), and di-
Moreover, section 108 of the CPSIA requires the Commission to convene a CHAP “to study the effects on children's health of all phthalates and phthalate alternatives as used in children's toys and child care articles.” The CPSIA requires the CHAP to complete an examination of the full range of phthalates that are used in products for children and:
• Examine all of the potential health effects (including endocrine disrupting effects) of the full range of phthalates;
• Consider the potential health effects of each of these phthalates, both in isolation and in combination with other phthalates;
• Examine the likely levels of children's, pregnant women's, and others' exposure to phthalates, based on a reasonable estimation of normal and foreseeable use and abuse of such products;
• Consider the cumulative effect of total exposure to phthalates, both from children's products and from other sources, such as personal care products;
• Review all relevant data, including the most recent, best available, peer-reviewed, scientific studies of these phthalates and phthalate alternatives that employ objective data collection practices or employ other objective methods;
• Consider the health effects of phthalates, not only from ingestion, but also as a result of dermal, hand-to-mouth, or other exposure;
• Consider the level at which there is a reasonable certainty of no harm to children, pregnant women, or other susceptible individuals and their offspring, reviewing the best available science, and using sufficient safety factors to account for uncertainties regarding exposure and susceptibility of children, pregnant women, and other potentially susceptible individuals; and
• Consider possible similar health effects of phthalate alternatives used in children's toys and child care articles.
The CPSIA contemplates completion of the CHAP's examination within 18 months of the panel's appointment. The CHAP must review prior work on phthalates by the Commission, but it is not to be considered determinative
The CHAP must make recommendations to the Commission about which phthalates, or combinations of phthalates (in addition to those identified in section 108 of the CPSIA), or phthalate alternatives should be prohibited from use in children's toys or child care articles or otherwise restricted. The Commission selected the CHAP members from scientists nominated by the National Academy of Sciences.
The CHAP met previously in April, July, and December 2010, and in March and July 2011, at the CPSC's offices in Bethesda, MD, and by teleconference in November 2010. The CHAP heard testimony from interested parties at the July 2010 meeting. The September 2011 conference call will include discussion of the CHAP's progress in its analysis of potential risks from phthalates and phthalate substitutes. There will not be any opportunity for public comment during the conference call.
Wednesday, September 21, 2011, 9 a.m.-12 p.m.
Room 420, Bethesda Towers, 4330 East West Highway, Bethesda, Maryland.
Commission Meeting—Open to the Public.
A live Webcast of the meeting can be viewed at
For a recorded message containing the latest agenda information, call (301) 504-7948.
Todd A. Stevenson, Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, (301) 504-7923.
Wednesday, September 21, 2011; 2-3 p.m.
Hearing Room 420, Bethesda Towers, 4330 East West Highway, Bethesda, Maryland.
Closed to the public.
The Commission staff will brief the Commission on the status of compliance matters.
For a recorded message containing the latest agenda information, call (301) 504-7948.
Todd A. Stevenson, Office of the Secretary, U.S. Consumer Product Safety Commission, 4330 East West Highway, Bethesda, MD 20814, (301) 504-7923.
Corporation for National and Community Service.
Notice.
The Corporation for National and Community Service (hereinafter the “Corporation”), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre-clearance consultation program to provide the general public and federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirement on respondents can be properly assessed. Individuals who use a telecommunications device for the deaf (TTY-TDD) may call (202) 565-2799 between 8:30 a.m. and 5 p.m. eastern time, Monday through Friday.
Currently, the Corporation is soliciting comments concerning AmeriCorps Application Instructions: State Commissions; State and National Competitive; Professional Corps; Indian Tribes; States and Territories without Commissions; and State and National Planning. Applicants will respond to the questions included in this ICR in order to apply for funding through these grant competitions.
Copies of the information collection request can be obtained by contacting the office listed in the
Written comments must be submitted to the individual and office listed in the
You may submit comments, identified by the title of the information collection activity, by any of the following methods:
(1) By mail sent to: Corporation for National and Community Service; Attention: Amy Borgstrom, Associate Director for Policy, Room 9515; 1201 New York Avenue, NW., Washington, DC 20525.
(2) By hand delivery or by courier to the Corporation's mailroom at Room 8100 at the mail address given in paragraph (1) above, between 9 a.m. and 4 p.m. Monday through Friday, except Federal holidays.
(3) By fax to: (202) 606-3476, Attention: Amy Borgstrom, Associate Director for Policy.
(4) Electronically through the Corporation's e-mail address system:
Amy Borgstrom, (202) 606-6930, or by e-mail at
The Corporation is particularly interested in comments that:
• Evaluate whether the proposed collection of information is necessary for the proper performance of the functions of the Corporation, including whether the information will have practical utility;
• 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;
• Enhance the quality, utility, and clarity of the information to be collected; and
• Minimize the burden of the collection of information on those who are expected to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology (
These application instructions will be used by applicants for funding through AmeriCorps State and National grant competitions.
The Corporation seeks to renew and revise the current AmeriCorps State and National Application Instructions. The Application Instructions are being revised for increased clarity and to align with provisions of the Serve America Act. The Application Instructions will be used in the same manner as the existing Application Instructions. The Corporation also seeks to continue using the current Application Instructions until the revised Application Instructions are approved by OMB. The current ICRs are due to expire on May 31, 2012.
Comments submitted in response to this notice will be summarized and/or included in the request for Office of Management and Budget approval of the information collection request; they will also become a matter of public record.
Department of Defense (DoD).
Notice of availability.
Inventory to be made publicly available by October 17, 2011.
Send written comments and suggestions concerning this inventory to: Jeffrey Grover, Senior Procurement Analyst, OUSD (AT&L), DPAP/CPIC, 3060 Defense Pentagon, Washington, DC 20301-3060, or e-mail
Jeffrey Grover, telephone 703-697-9352.
In accordance with section 2330a of title 10 United States Code, as amended by section 807 of the National Defense Authorization Act for Fiscal Year 2008, the Office of the Deputy Director, Defense Procurement and Acquisition Policy, Contract Policy and International Contracting (DPAP/CPIC) will make available to the public the annual inventory of contracts for services. The inventory will be posted to the Defense Procurement and Acquisition Policy Web site at
Department of the Air Force, U.S. Air Force Scientific Advisory Board
Meeting Notice.
Under the provisions of the
The purpose of this Air Force Scientific Advisory Board quarterly meeting is to introduce the FY12 SAB study topics tasked by the Secretary of the Air Force and receive presentations that address relevant subjects to the SAB mission to include introduction of the new Board members for FY12, status of FY11 studies and the FY12 Board schedule; the Air Force's high dependence on space for navigation, timing, communications, weather, and intelligence, surveillance, reconnaissance; increased space asset vulnerability; latest updates on the ongoing Aircraft Oxygen Generation Study by the Board; Air Force Global Strike Command overview highlighting high priority capability gaps and technology solution partnerships; Air Force Research Laboratory overview focusing on the Air Force Science and Technology plan emphasizing next generation energy, autonomy, sustainment, cyber, and ISR capabilities; improving the value of intelligence data collection and maximizing timely insight and safe and secure cyber ops; acquisition challenges amid new era of defense policy and lessons learned from challenged acquisition programs; and balancing today's needs with tomorrow's challenges to prepare for full-spectrum operations.
In accordance with 5 U.S.C. 552b, as amended, and 41 CFR 102-3.155, The Administrative Assistant of the Air Force, in consultation with the Air Force General Counsel, has agreed that the public interest requires some sessions of the United States Air Force Scientific Advisory Board meeting be closed to the public because they will discuss information and matters covered by sections 5 U.S.C. 552b(c)(1).
Any member of the public wishing to provide input to the United States Air Force Scientific Advisory Board should submit a written statement in accordance with 41 CFR 102-3.140(c) and section 10(a)(3) of the Federal Advisory Committee Act and the procedures described in this paragraph. Written statements can be submitted to the Designated Federal Officer at the address detailed below at any time. Statements being submitted in response to the agenda mentioned in this notice must be received by the Designated
The United States Air Force Scientific Advisory Board Executive Director and Designated Federal Officer, Lt. Col. Matthew E. Zuber, 301-981-7135, United States Air Force Scientific Advisory Board, 1602 California Ave., Ste. #251, Andrews AFB, MD 20762,
Department of Education.
Comment request.
The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13).
Interested persons are invited to submit comments on or before October 17, 2011.
Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Education Desk Officer, Office of Management and Budget, 725 17th Street, NW., Room 10222, New Executive Office Building, Washington, DC 20503, be faxed to (202) 395-5806 or e-mailed to
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. The OMB is particularly interested in comments which: (1) 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; (2) 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; (3) Enhance the quality, utility, and clarity of the information to be collected; and (4) 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.
ED will use this Generic Application package for discretionary grant programs that: (1) Use the standard ED or Federal-wide grant application forms that have been cleared separately through OMB and (2) use selection criteria from the Education Department General Administrative Regulations (EDGAR); statutory selection criteria or a combination of EDGAR and statutory selection criteria authorized under EDGAR, 34 CFR 75.200. The use of the standard ED grant application forms and the use of EDGAR and/or statutory selection criteria promote the standardization and streamlining of ED discretionary grant application packages.
Copies of the information collection submission for OMB review may be accessed from the
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
Department of Education.
Comment request.
The Director, Information Collection Clearance Division, Privacy, Information and Records Management Services, Office of Management, invites comments on the submission for OMB review as required by the Paperwork Reduction Act of 1995 (Pub. L. 104-13).
Interested persons are invited to submit comments on or before October 17, 2011.
Written comments should be addressed to the Office of Information and Regulatory Affairs, Attention: Education Desk Officer, Office of Management and Budget, 725 17th Street, NW., Room 10222, New Executive Office Building, Washington, DC 20503, be faxed to (202) 395-5806 or e-mailed to
Section 3506 of the Paperwork Reduction Act of
Copies of the information collection submission for OMB review may be accessed from the
Individuals who use a telecommunications device for the deaf (TDD) may call the Federal Information Relay Service (FIRS) at 1-800-877-8339.
U.S. Department of Energy.
Notice and Request for OMB Review and Comment.
The Department of Energy (DOE) has submitted to the Office of Management and Budget (OMB) for clearance, a proposal for collection of information under the provisions of the
Comments regarding this collection must be received on or before October 17, 2011. If you anticipate that you will be submitting comments, but find it difficult to do so within the period of time allowed by this notice, please advise the DOE Desk Officer at OMB of your intention to make a submission as soon as possible. The Desk Officer may be telephoned at 202-395-4650.
Written comments should be sent to the
Carol Hellmann,
The information collection instrument may be viewed at
This information collection request contains: (1)
10 CFR 600.112.
Department of Energy; Office of Science.
Notice of open meeting.
This notice announces a meeting of the Biological and Environmental Research Advisory Committee (BERAC). The Federal Advisory Committee Act (Pub. L. 92-463, 86 Stat. 770) requires that public notice of these meetings be announced in the
Thursday, October 6, 2011 9 a.m. to 5 p.m. and Friday, October 7, 2011 8:30 a.m. to 12:30 p.m.
Hilton Washington DC/Rockville Hotel and Executive Meeting Center, 1750 Rockville Pike, Rockville, Maryland 20852.
Dr. David Thomassen, Designated Federal Officer, BERAC, U.S. Department of Energy, Office of Science, Office of Biological and Environmental Research, SC-23/Germantown Building, 1000 Independence Avenue, SW., Washington, DC 20585-1290. Phone 301-903-9817; fax (301) 903-5051 or email:
• Report from the Office of Biological and Environmental Research
• News from the Biological Systems Science and Climate and Environmental Sciences Divisions
• Discussions on the Biological Systems Science Division Committee of Visitors
• Workshop Reports
• New Business
• Public Comment
Take notice that the following hydroelectric application has been filed with the Commission and is available for public inspection:
a.
b.
c.
d.
e.
f.
g.
h:
i.
j.
All documents may be filed electronically via the Internet. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site
The Commission's Rules of Practice and Procedure require all intervenors filing documents with the Commission to serve a copy of that document on each person whose name appears on the official service list for the project. Further, if an intervenor files comments or documents with the Commission relating to the merits of an issue that may affect the responsibilities of a particular resource agency, they must also serve a copy of the document on that resource agency.
k.
Southern California Edison Company states in its temporary variance request that as the lake is drawn down, daily inspections will be performed to determine the impact on fish species as well as conducting fish rescues if stranding is found. Once lake levels have stabilized, a qualified biologist will survey the area four times as week to collect and record any fish mortality. Any fish mortality that occurred during the dewatering of the lake will be replaced.
l. A copy of the application is available for review at the Commission in the Public Reference Room or may be viewed on the Commission's website at
You may also register online at
m. Individuals desiring to be included on the Commission's mailing list should so indicate by writing to the Secretary of the Commission.
Anyone may submit comments, a protest, or a motion to intervene in accordance with the requirements of Rules of Practice and Procedure, 18 CFR 385.210, .211, .214. In determining the appropriate action to take, the Commission will consider all protests or other comments filed, but only those who file a motion to intervene in accordance with the Commission's Rules may become a party to the proceeding. Any comments, protests, or motions to intervene must be received on or before the specified comment date for the particular application.
Any filings must bear in all capital letters the title “COMMENTS,” “PROTEST,” or “MOTION TO INTERVENE,” as applicable, and the Project Number of the particular application to which the filing refers. A copy of any motion to intervene must also be served upon each representative of the Applicant specified in the particular application.
Federal, state, and local agencies are invited to file comments on the described application. A copy of the application may be obtained by agencies directly from the applicant. If an agency does not file comments within the time specified for filing comments, it will be presumed to have no comments. One copy of an agency's comments must also be sent to the Applicant's representatives.
This is a supplemental notice in the above-referenced proceeding of Santana Energy Services' application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR Part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR Part 34, of future issuances of securities and assumptions of liability, is September 28, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the Commission's eLibrary system by clicking on the appropriate link in the above list. They are also available for review in the Commission's Public Reference Room in Washington, DC. There is an eSubscription link on the web site that enables subscribers to receive email notification when a document is added to a subscribed docket(s). For assistance with any FERC Online service, please email
This is a supplemental notice in the above-referenced proceeding of NEPM II, LLC's application for market-based rate authority, with an accompanying rate tariff, noting that such application includes a request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability.
Any person desiring to intervene or to protest should file with the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426, in accordance with Rules 211 and 214 of the Commission's Rules of Practice and Procedure (18 CFR 385.211 and 385.214). Anyone filing a motion to intervene or protest must serve a copy of that document on the Applicant.
Notice is hereby given that the deadline for filing protests with regard to the applicant's request for blanket authorization, under 18 CFR part 34, of future issuances of securities and assumptions of liability, is September 28, 2011.
The Commission encourages electronic submission of protests and interventions in lieu of paper, using the FERC Online links at
Persons unable to file electronically should submit an original and 14 copies of the intervention or protest to the Federal Energy Regulatory Commission, 888 First Street, NE., Washington, DC 20426.
The filings in the above-referenced proceeding are accessible in the
Take notice that on August 26, 2011, Dominion Transmission, Inc. (Dominion), 701 East Cary Street, Richmond, Virginia 23219, filed in Docket No. CP11-540-000, a prior notice request pursuant to sections 157.205 and 157.208 of the Commission's regulations under the Natural Gas Act (NGA). Dominion seeks authorization to construct, install, own, and operate certain pipeline facilities in Marshall County, West Virginia. Dominion proposes to perform these activities under its blanket certificate originally issued in Docket No. CP82-537-000 [21 FERC ¶ 62,172 (1982)], all as more fully set forth in the application which is on file with the Commission and open to public inspection.
The filing may be viewed on the Web at
Any questions regarding this application should be directed to Brad Knisley, Regulatory and Certificates Analyst, Dominion Transmission, Inc., 701 East Cary Street, Richmond, Virginia 23219, or by calling (804) 771-4122 (telephone) or (804) 771-4804 (fax),
Any person or the Commission's Staff may, within 60 days after the issuance of the instant notice by the Commission, file pursuant to Rule 214 of the Commission's Procedural Rules (18 CFR 385.214) a motion to intervene or notice of intervention and, pursuant to section 157.205 of the Commission's Regulations under the NGA (18 CFR 157.205) a protest to the request. If no protest is filed within the time allowed therefore, the proposed activity shall be deemed to be authorized effective the day after the time allowed for protest. If a protest is filed and not withdrawn within 30 days after the time allowed for filing a protest, the instant request shall be treated as an application for authorization pursuant to section 7 of the NGA.
The Commission strongly encourages electronic filings of comments, protests, and interventions via the Internet in lieu of paper. See 18 CFR 385.2001(a)(1)(iii) and the instructions on the Commission's Web site (
Environmental Protection Agency (EPA).
Notice.
EPA is announcing the availability of the draft test guidelines for Series 810—Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents, concerning specifically air, textiles, and water.
Comments must be received on or before December 14, 2011.
Submit your comments, identified by docket identification (ID) number EPA-HQ-OPP-2009-0681, by one of the following methods:
•
•
•
This action is directed to the public in general. Although this action may be of particular interest to those persons who are or may be required to conduct testing of chemical substances under TSCA, FFDCA, or FIFRA, the Agency has not attempted to describe all the specific entities that may be affected by this action. If you have any questions regarding the applicability of this action to a particular entity, consult the technical person listed under
1.
2.
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at the estimate.
vi. Provide specific examples to illustrate your concerns and suggested alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
EPA is announcing the availability of the draft test guidelines for Series 810—Product Performance Test Guidelines for Public Health Uses of Antimicrobial Agents:
1. Disinfectants and Sanitizers for Use on Fabrics and Textiles—Efficacy Data Recommendations (OCSPP Guideline 810.2400).
2. Air Sanitizers—Efficacy Data Recommendations (OCSPP Guideline 810.2500).
3. Disinfectants for Use in Water—Efficacy Data Recommendations (OCSPP Guideline 810.2600).
These draft test guidelines address efficacy testing for antimicrobial agents intended to be used on hard, inanimate, environmental surfaces; in the air; and in water, and which bear label claims as disinfectants and/or sanitizers. Data from these studies are used to support the labeling claims for public health related antimicrobial agents.
As a guidance document, the test guidelines are not binding on either EPA or any outside parties. At places in this guidance, the Agency uses the word “should.” In this guidance, use of “should” with regard to an action means that the action is recommended rather than mandatory. The procedures contained in the test guidelines are recommended for generating the data that are the subject of the test guideline, but EPA recognizes that departures may be appropriate in specific situations. EPA will consider alternatives to the recommendations described in the test guidelines on a case-by-case basis, after assessing whether the alternative will provide the data necessary to inform the regulatory decision that must be made.
The product performance guidelines for antimicrobial agents were last updated in 1982 under the “Pesticide Assessment Guidelines—Subdivision G, Product Performance.” Since then, the Agency has presented several issues at two separate meetings of the FIFRA SAP related to the conduct of studies for antimicrobial agents (the first meeting September 9-10, 1997, announced in the
On October 8, 2008, EPA published in the
This notice of availability does not involve a proposed regulatory action that would require the Agency to consider voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act of 1995 (NTTAA), Public Law 104-113, section 12(d) (15 U.S.C. 272 note). Section 12(d) of NTTAA directs EPA to use voluntary consensus standards in its regulatory activities unless to do so would be inconsistent with applicable law or otherwise impractical. Voluntary consensus standards are technical standards (
These test guidelines represent an Agency effort to harmonize the test guidelines within OCSPP, as well as to harmonize the OCSPP test guidelines with those of OECD. The process for developing and amending these test guidelines, which began in 1991, includes public participation and the extensive involvement of the scientific community, including peer review by SAP and the SAB and other expert scientific organizations.
In the future, these test guidelines could be incorporated into regulatory actions taken by EPA under TSCA,
Environmental protection, Antimicrobial agents, Chemicals, Harmonized test guidelines, Health and safety.
Environmental Protection Agency (EPA).
Notice of Public Comment Period and Listening Session; Extension.
EPA announced a 60-day public comment period and a listening session on August 31, 2011 (76 FR 54227) for the external review draft human health assessment titled, “Toxicological Review of n-Butanol: In Support of Summary Information on the Integrated Risk Information System (IRIS)” (EPA/635/R-11/081A). EPA is extending the public comment period one week because of a one-week delay in the release of the Toxicological Review to the public. The draft assessment was prepared by the National Center for Environmental Assessment (NCEA) within the EPA Office of Research and Development (ORD). EPA is releasing this draft assessment solely for the purpose of pre-dissemination peer review under applicable information quality guidelines. This draft assessment has not been formally disseminated by EPA. It does not represent and should not be construed to represent any Agency policy or determination. After public review and comment, an EPA contractor will convene an expert panel for independent external peer review of this draft assessment. The public comment period and external peer review meeting are separate processes that provide opportunities for all interested parties to comment on the assessment. The external peer review meeting will be scheduled at a later date and announced in the
The listening session will be held on October 26, 2011, during the public comment period for this draft assessment. The purpose of the listening session is to allow all interested parties to present scientific and technical comments on draft IRIS health assessments to EPA and other interested parties attending the listening session.
The public comment period will be extended to end November 7, 2011. Comments should be in writing and must be received by EPA by November 7, 2011.
The listening session on the draft assessment for n-Butanol will be held on October 26, 2011, beginning at 9 a.m. and ending at 4 p.m., Eastern Daylight Time or when the last presentation has been completed. To attend the listening session, interested parties should register no later than October 19, 2011, following the instructions in the August 31
The draft “Toxicological Review of n-Butanol: In Support of Summary Information on the Integrated Risk Information System (IRIS)” is available primarily via the Internet on the NCEA home page under the Recent Additions and Publications menus at
Comments may be submitted electronically via
For information on the draft assessment, please contact Ambuja Bale, National Center for Environmental Assessment [Mail Code: (8601-P)], U.S. Environmental Protection Agency, National Center for Environmental Assessment, Office of Research and Development, U.S. Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460;
Environmental Protection Agency (EPA).
Notice.
This notice announces receipt of applications to register new uses for pesticide products containing currently registered active ingredients, pursuant to the provisions of section 3(c) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), as amended. EPA is publishing this Notice of such applications, pursuant to section 3(c)(4) of FIFRA.
Comments must be received on or before October 17, 2011.
Submit your comments, identified by the docket identification (ID) number specified within the table below, by one of the following methods:
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A contact person is listed at the end of each registration application summary and may be contacted by telephone or e-mail. The mailing address for each contact person listed is: Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001 or Biopesticides and Pollution Prevention Division (7511P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.
You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:
• Crop production (NAICS code 111).
• Animal production (NAICS code 112).
• Food manufacturing (NAICS code 311).
• Pesticide manufacturing (NAICS code 32532).
This listing is not intended to be exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The North American Industrial Classification System (NAICS) codes have been provided to assist you and others in determining whether this action might apply to
i. Identify the document by docket ID number and other identifying information (subject heading,
ii. Follow directions. The Agency may ask you to respond to specific questions or organize comments by referencing a Code of Federal Regulations (CFR) part or section number.
iii. Explain why you agree or disagree; suggest alternatives and substitute language for your requested changes.
iv. Describe any assumptions and provide any technical information and/or data that you used.
v. If you estimate potential costs or burdens, explain how you arrived at your estimate in sufficient detail to allow for it to be reproduced.
vi. Provide specific examples to illustrate your concerns and suggest alternatives.
vii. Explain your views as clearly as possible, avoiding the use of profanity or personal threats.
viii. Make sure to submit your comments by the comment period deadline identified.
EPA received applications as follows to register pesticide products containing currently registered active ingredients pursuant to the provisions of section 3(c) of FIFRA, and is publishing this Notice of such applications pursuant to section 3(c)(4) of FIFRA. Notice of receipt of these applications does not imply a decision by the Agency on the applications.
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Environmental protection, Pesticides and pest.
The Advisory Committee was established by Public Law 98-181, November 30, 1983, to advise the Export-Import Bank on its programs and to provide comments for inclusion in the reports of the Export-Import Bank of the United States to Congress.
Susan Houser, Room 1273, 811 Vermont Ave., NW., Washington, DC 20571, (202) 565-3232.
Pursuant to the provisions of subsection (e)(2) of the “Government in the Sunshine Act” (5 U.S.C. 552b(e)(2)), notice is hereby given that at its open meeting held at 9:57 a.m. on Tuesday, September 13, 2011, the Corporation's Board of Directors determined, on motion of Director Thomas J. Curry (Appointive), seconded by Director John G. Walsh (Acting Comptroller of the Currency), and concurred in by Acting Chairman Martin J. Gruenberg, that Corporation business required the addition to the agenda for consideration at the meeting, on less than seven days' notice to the public, of the following matters:
The Board further determined, by the same majority vote, that no notice earlier than September 7, 2011, of the change in the subject matter of the meeting was practicable.
Pursuant to the provisions of the “Government in the Sunshine Act” (5 U.S.C. 552b), notice is hereby given that at 10:39 a.m. on Tuesday, September 13, 2011, the Board of Directors of the Federal Deposit Insurance Corporation met in closed session to consider matters related to the Corporation's supervision, corporate, and resolution activities.
In calling the meeting, the Board determined, on motion of Director Thomas J. Curry (Appointive), seconded by Director John G. Walsh (Acting Comptroller of the Currency), and concurred in by Acting Chairman Martin J. Gruenberg, that Corporation business required its consideration of the matters which were to be the subject of this meeting on less than seven days' notice to the public; that no earlier notice of the meeting was practicable; that the public interest did not require consideration of the matters in a meeting open to public observation; and that the matters could be considered in a closed meeting by authority of subsections (c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10) of the “Government in the Sunshine Act” (5 U.S.C. 552b(c)(4), (c)(6), (c)(8), (c)(9)(A)(ii), (c)(9)(B), and (c)(10)).
The meeting was held in the Board Room of the FDIC Building located at 550 17th Street, NW., Washington, DC.
Notice is Hereby Given that the Federal Deposit Insurance Corporation (“FDIC”) as Receiver for Metropolitan Savings Bank, (“the Receiver”) intends to terminate its receivership for said institution. The FDIC was appointed receiver of Metropolitan Savings Bank on February 2, 2007. The liquidation of the receivership assets has been completed. To the extent permitted by available funds and in accordance with law, the Receiver will be making a final dividend payment to proven creditors.
Based upon the foregoing, the Receiver has determined that the continued existence of the receivership will serve no useful purpose. Consequently, notice is given that the receivership shall be terminated, to be effective no sooner than thirty days after the date of this Notice. If any person wishes to comment concerning the termination of the receivership, such comment must be made in writing and sent within thirty days of the date of this Notice to: Federal Deposit Insurance Corporation, Division of Resolutions and Receiverships,
No comments concerning the termination of this receivership will be considered which are not sent within this timeframe.
Federal Election Commission.
Tuesday, September 13, and Thursday, September 15, 2011 at 10 a.m.
999 E Street, NW., Washington, DC (Ninth Floor).
This meeting is closed to the public.
The September 13, 2011 meeting was canceled.
Judith Ingram, Press Officer, Telephone: (202) 694-1220.
Board of Governors of the Federal Reserve System.
Under authority delegated to the Board of Governors of the Federal Reserve System (Board) by the Office of Management and Budget (OMB) under the Paperwork Reduction Act (PRA), the Board is requesting comment on four surveys related to its obligations under section 920(a) of the Electronic Fund Transfer Act (EFTA). Two surveys request information about the prevalence of the use of general-use prepaid cards in federal, state, and local government-administered payment programs and the interchange and cardholder fees charged with respect to this use. The Board is proposing to conduct these surveys to collect information necessary to meet its obligation under EFTA section 920(a)(7)(D) to submit an annual report to the Congress on such programs and fees. One of these surveys will require information from issuers of government-administered, general-use prepaid cards, in accordance with the Board's information collection authority in section 920(a)(3)(B) of the EFTA. The other survey, which is voluntary, will be directed to state governments that administer general-use prepaid cards.
The Board is also requesting comment on two mandatory surveys, one for debit card issuers and one for payment card networks, that will collect information on costs, debit card usage, and interchange fees. These surveys will enable the Board to meet its obligation under EFTA section 920(a)(3) to disclose aggregate or summary information concerning the costs incurred and interchange fees charged or received by issuers or payment card networks in connection with the authorization, clearance or settlement of electronic debit transactions.
Comments must be submitted on or before November 14, 2011.
You may submit comments, identified by FR 3063a or b (government-administered, general-use prepaid cards), FR 3064a (debit card issuers), or FR 3064b (payment card networks), by any of the following methods:
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Additionally, commenters should send a copy of their comments to the OMB Desk Officer, Shagufta Ahmed, by mail to Office of Information and Regulatory Affairs, Office of Management and Budget, New Executive Office Building, Room 10235, 725 17th Street, NW., Washington, DC 20503 or by fax to 202-395-6974.
All public comments are available on the Board's Web site at
Jennifer Williams, Senior Financial Services Analyst (202-452-2446), Division of Reserve Bank Operations and Payment Systems, Board of Governors of the Federal Reserve System, Washington, DC 20551, for FR 3063a or b (government-administered, general-use prepaid cards).
Edith Collis, Senior Financial Services Analyst (202-452-3638), Division of Reserve Bank Operations and Payment Systems, Board of Governors of the Federal Reserve System, Washington, DC 20551, for FR 3064a (debit card issuers).
Linda Healey, Senior Financial Services Analyst (202-452-5274), Division of Reserve Bank Operations and Payment Systems, Board of
A copy of the PRA OMB submission, including the proposed surveys, supporting statement, and other documentation will be placed into OMB's public docket files, once approved. These documents will also be made available on the Board's public Web site at:
Cynthia Ayouch, Federal Reserve Board Clearance Officer (202-452-3829), Division of Research and Statistics, Board of Governors of the Federal Reserve System, Washington, DC 20551. Telecommunications Device for the Deaf (TDD) users may contact (202-263-4869), Board of Governors of the Federal Reserve System, Washington, DC 20551.
On June 15, 1984, the OMB delegated to the Board its approval authority under the PRA, pursuant to 5 CFR 1320.16, to approve of and assign OMB control numbers to collection of information requests and requirements conducted or sponsored by the Board under conditions set forth in 5 CFR Part 1320 Appendix A.1. Board-approved collections of information are incorporated into the official OMB inventory of currently approved collections of information. Copies of the PRA submission, supporting statements and approved collection of information instruments are placed into OMB's public docket files. The Board may not conduct or sponsor, and a respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.
The following information collections, which are being handled under OMB delegated authority, have received initial Board approval and are hereby published for comment. After the comment deadline, the proposed information collections, along with an analysis of comments and recommendations received, will be submitted to the Board for final approval under this delegated authority. The Board requests comment on all aspects of the proposed surveys, as discussed further below, including the following:
a. Whether the proposed collection of information is necessary for the proper performance of the Board's functions, including whether the information has practical utility;
b. The accuracy of the Board's estimate of the burden of the proposed information collection, including the validity of the methodology and assumptions used;
c. Ways to enhance the quality, utility, and clarity of the information to be collected; and
d. Ways to minimize the burden of information collection on respondents, including through the use of automated collection techniques or other forms of information technology.
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The obligation of issuers to respond to the issuer survey (FR 3063a) is mandatory. Some of the data collected by FR 3063a may be kept confidential under exemption (b)(4) of the Freedom of Information Act (FOIA), which exempts from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” 5 U.S.C. 552(b)(4). Information collected under FR 3063a can be kept confidential under exemption (b)(4) if the release of data would cause substantial harm to the competitive position of the issuer.
The obligation of state governments to respond to the government survey (FR 3063b) is voluntary. The Board anticipates that all of the information collected by FR 3063b would be publicly available information and would not be given confidential treatment.
The Board specifically requests comment on the following:
a. What information collected by the issuer survey (FR 3063a) would consist of trade secrets or commercial or financial information;
b. Whether information collected by the government survey (FR 3063b) is publicly available information; and
c. Whether there are issuers of government-administered, general-use prepaid cards that are not depository institutions, and, if so, should the depository institution holding the insured deposits underlying the cards be required to report on behalf of those issuers.
On March 24, 2011, the Board distributed two surveys to industry participants (a depository institution survey and a state government survey) designed to assist the Board in meeting the reporting requirements in section 920(a) related to the prevalence of the use of general-use prepaid cards in federal, state, or local government-administered payment programs and
In general, the issuer survey (FR 3063a) would collect information separately for each government-administered program for which the depository institution is the issuer of general-use prepaid cards as well as in the aggregate for all programs. The issuer survey would collect information on card programs using two types of authentication mechanisms: dual-message transactions (those generally requiring a signature) and single-message transactions (those generally requiring the input of a personal identification number (PIN)).
The Board specifically requests comment on the following:
a. The best terms to use in identifying types of authentication mechanisms (single-message and dual-message versus PIN and signature) given that not all dual-message transactions require a signature and not all single-message transactions require a PIN.
The issuer survey would comprise 10 sections:
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II.
The Board specifically requests comment on the following:
a. The ability of issuers to provide the total number of recipients receiving payments, regardless of payment method.
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IV.
The Board specifically requests comment on the following:
a. The ability of issuers to provide the total value of all funds disbursed, regardless of payment method.
b. Whether any funding patterns during the month may change significantly an issuer's response depending on the as-of date requested.
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The Board specifically requests comment on the following:
a. Whether fees paid for over-the-counter at-bank (teller) cash withdrawals should be included in the survey.
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Responding to the government survey (FR 3063b) would be voluntary for approximately 60 government entities, including the states, the District of Columbia, and U.S. territories (collectively “state governments”). The survey would collect information about the prevalence of use of general-use prepaid cards in federal, state, and local government-administered payment programs.
The government survey would comprise four sections:
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The issuer survey (FR 3063a) and the government survey (FR 3063b) would be made available online by mid-February 2012 and would request that the surveys be completed and returned to the Board within 30 calendar days.
The Board specifically requests comment on the following:
a. Whether 30 calendar days allows sufficient time for respondents to complete the proposed surveys.
2.
The obligation to respond to these surveys is mandatory. In accordance with the statutory requirement, the Board will release aggregate or summary information from the survey responses. Some of the data collected by the surveys may be kept confidential under exemption (b)(4) of FOIA, which exempts from disclosure “trade secrets and commercial or financial information obtained from a person and privileged or confidential.” 5 U.S.C. 552(b)(4). Information collected under the surveys can be kept confidential under exemption (b)(4) if the release of data would cause substantial harm to the competitive position of the respondent.
On September 13, 2010, the Board distributed three surveys to industry participants (a card issuer survey, a payment card network survey, and a merchant acquirer/processor survey) designed to gather information to assist the Board in developing Regulation II. Industry participants, including payment card networks, trade groups, and individual firms from both the banking industry and merchant community, commented on preliminary versions of the 2010 issuer and network surveys, through both written submissions and a series of drop-in calls. In response to the comments, the two surveys were modified, as appropriate.
The Board specifically requests comment on the following:
a. The feasibility of requiring each chartered entity that issues debit cards to complete a separate survey rather than requiring a holding company to complete one survey for all its chartered entities, as was done in the 2010 card issuer survey (12 CFR 235.8(b)).
In general, the debit card issuer survey (FR 3064a) would collect information on card programs that use two types of authentication mechanisms: Dual-message transactions (those generally requiring a signature) and single-message transactions (those generally requiring the input of a personal identification number (PIN)). Both programs include general-use prepaid card transactions.
The Board specifically requests comment on the following:
a. The best terms to use in identifying types of processing (single-message and dual-message versus PIN and signature) given that not all dual-message transactions require a signature and not all single-message transactions require a PIN.
b. Whether issuers should report general-use prepaid card data combined with other transaction data related to single- or dual-message systems (and if so, whether they would be able to do so) or should report general-use prepaid card activity separately.
The debit card issuer survey would comprise four sections:
I.
II.
The Board specifically requests comment on the following:
a. Whether the guidance provided in the proposed survey is sufficient for issuers to report authorization, clearing, and settlement costs;
b. The usefulness of including a checklist of fraud prevention activities and, if so, which fraud prevention activities should be included in the checklist for the 2012 survey. If a checklist is provided in the survey, are the activities proposed in the draft survey (transaction monitoring, merchant blocking, data security, and PIN customization) the right categories or are other categories more meaningful? If a checklist is provided in the survey, the listed activities could be updated over time based on “other” activities reported.
c. The issuers' ability to allocate payments and incentives as specified and whether other major categories of payments and incentives should be included.
d. The issuers' ability to report the subset of customer service costs associated with customer inquiries regarding particular debit card transactions (as opposed to customer inquiries regarding the account, the debit card more generally, or credit cards/ATM cards).
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IV.
The payment card network survey (FR 3064b) would require payment card networks to submit information about debit card (including general-use prepaid card) transaction volume and value; interchange fees; other network fees; and incentives and discounts paid to acquirers, merchants, and issuers.
The network survey would comprise two sections:
I.
II.
The Board specifically requests comment on the following:
a. The payment card networks' ability to identify separately general-use prepaid card transactions from other debit card transactions.
b. Whether the networks can provide data for exempt and non-exempt issuers that compares information for three time periods: January 1 to June 30, 2011 (during which all transactions would be considered exempt); July 1 to September 30, 2011 (during which all transactions could be considered exempt, but some networks may begin to distinguish between exempt and non-exempt issuers, if such networks are offering a tiered interchange fee schedule); and October 1, 2011 to December 31, 2011 (during which all networks that provide a tiered interchange fee schedule would distinguish between exempt and non-exempt issuers).
The Board would make the payment card network survey available online by mid-January 2012 and would request that the survey be completed and submitted to the Board within 30 calendar days. The debit card issuer survey would be made available by mid-February 2012 and would request that the survey be completed and submitted to the Board within 60 calendar days.
By order of the Board of Governors of the Federal Reserve System, September 12, 2011.
Federal Trade Commission.
Proposed Consent Agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before October 10, 2011.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Stacey Ferguson (202-326-2361) or James A. Prunty (202-326-2438), FTC, Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW., Washington, DC 20580.
Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 U.S.C. 46(f), and §2.34 the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for September 8, 2011), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before October 10, 2011. Write “DERMAPPS, File No. 102 3205” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “DERMAPPS, File No. 102 3205” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Kobe Brown and Gregory W. Pearson, dba DERMAPPS (“respondents”).
The proposed consent order (“proposed order”) has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.
This matter involves the advertising of a mobile software application (“app”) called AcneApp which respondents developed and sold in Apple's iTunes Store. Respondents claimed that AcneApp effectively treats acne. The instructions for this app directed consumers to hold the light-emitting display screen next to the area of skin to be treated for several minutes each day.
The Commission's complaint alleges that respondents violated Sections 5 and 12 of the FTC Act by claiming, without substantiation, that the app provided an effective treatment for acne. The complaint also alleges that the respondents falsely represented that a study published in the British Journal of Dermatology proves that blue and red light therapy, such as that provided by AcneApp, is an effective treatment for acne.
The proposed consent order contains provisions designed to prevent respondents from engaging in similar practices in the future. Part I of the order prohibits respondents from making any representation that AcneApp, or any other device, as defined by Section 15 of the FTC Act, provides effective treatment for acne, unless respondents have competent and reliable scientific evidence to substantiate that claim.
Part II of the order requires respondents to have competent and reliable scientific evidence before making any safety, performance, benefits, or efficacy claim about any device.
Part III of the order is a standard order provision relating to establishment claims, prohibiting the misrepresentation of any research, tests, or studies.
Part IV of the order requires respondents, within 15 days of the order, to pay the Commission $14,294.
The remaining parts of the proposed order are standard provisions regarding record-keeping, dissemination of the order to officers and employees, prior notification to the Commission of corporate changes, notification of new employment, filing compliance of reports, and sunsetting of the order.
The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.
By direction of the Commission.
Federal Trade Commission.
Proposed Consent Agreement.
The consent agreement in this matter settles alleged violations of federal law prohibiting unfair or deceptive acts or practices or unfair methods of competition. The attached Analysis to Aid Public Comment describes both the allegations in the draft complaint and the terms of the consent order—embodied in the consent agreement—that would settle these allegations.
Comments must be received on or before October 10, 2011.
Interested parties may file a comment online or on paper, by following the instructions in the Request for Comment part of the
Stacey Ferguson (202-326-2361) or James A. Prunty (202-326-2438), FTC, Bureau of Consumer Protection, 600 Pennsylvania Avenue, NW., Washington, DC 20580.
Pursuant to section 6(f) of the Federal Trade Commission Act, 38 Stat. 721, 15 USC 46(f), and § 2.34 the Commission Rules of Practice, 16 CFR 2.34, notice is hereby given that the above-captioned consent agreement containing a consent order to cease and desist, having been filed with and accepted, subject to final approval, by the Commission, has been placed on the public record for a period of thirty (30) days. The following Analysis to Aid Public Comment describes the terms of the consent agreement, and the allegations in the complaint. An electronic copy of the full text of the consent agreement package can be obtained from the FTC Home Page (for September 8, 2011), on the World Wide Web, at
You can file a comment online or on paper. For the Commission to consider your comment, we must receive it on or before October 10, 2011. Write “Andrew N. Finkel, File No. 102 3206” on your comment. Your comment—including your name and your state—will be placed on the public record of this proceeding, including, to the extent practicable, on the public Commission Web site, at
Because your comment will be made public, you are solely responsible for making sure that your comment does not include any sensitive personal information, like anyone's Social Security number, date of birth, driver's license number or other state identification number or foreign country equivalent, passport number, financial account number, or credit or debit card number. You are also solely responsible for making sure that your comment does not include any sensitive health information, like medical records or other individually identifiable health information. In addition, do not include any “[t]rade secret or any commercial or financial information which is obtained from any person and which is privileged or confidential,” as provided in Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 16 CFR 4.10(a)(2). In particular, do not include competitively sensitive information such as costs, sales statistics, inventories, formulas, patterns, devices, manufacturing processes, or customer names.
If you want the Commission to give your comment confidential treatment, you must file it in paper form, with a request for confidential treatment, and you have to follow the procedure explained in FTC Rule 4.9(c), 16 CFR 4.9(c).
Postal mail addressed to the Commission is subject to delay due to heightened security screening. As a result, we encourage you to submit your comments online. To make sure that the Commission considers your online comment, you must file it at
If you file your comment on paper, write “Andrew N. Finkel, File No. 102 3206” on your comment and on the envelope, and mail or deliver it to the following address: Federal Trade Commission, Office of the Secretary, Room H-113 (Annex D), 600 Pennsylvania Avenue, NW., Washington, DC 20580. If possible, submit your paper comment to the Commission by courier or overnight service.
Visit the Commission Web site at
The Federal Trade Commission (“FTC” or “Commission”) has accepted, subject to final approval, an agreement containing a consent order from Andrew N. Finkel (“respondent”).
The proposed consent order (“proposed order”) has been placed on the public record for thirty (30) days for receipt of comments by interested persons. Comments received during this period will become part of the public record. After thirty (30) days, the Commission will again review the agreement and the comments received, and will decide whether it should withdraw from the agreement and take appropriate action or make final the agreement's proposed order.
This matter involves the advertising of a mobile software application (“app”) called Acne Pwner which respondent developed and sold in Google's Android Marketplace. Respondent claimed that Acne Pwner effectively treats acne. The instructions for this app directed consumers to hold the light-emitting display screen next to the area of skin to be treated for a few minutes each day.
The Commission's complaint alleges that respondent violated Sections 5 and 12 of the FTC Act by claiming, without substantiation, that the app provided an effective treatment for acne.
The proposed consent order contains provisions designed to prevent respondent from engaging in similar practices in the future. Part I of the order prohibits respondent from making any representation that Acne Pwner, or any other device as defined by Section 15 of the FTC Act, provides effective treatment for acne, unless respondent has competent and reliable scientific evidence to substantiate that claim.
Part II of the order requires respondent to have competent and reliable scientific evidence before making any safety, performance, benefits, or efficacy claim about any device.
Part III of the order requires respondent, within 15 days of the date the order becomes final, to pay the Commission $1,700.
The remaining parts of the proposed order are standard provisions regarding recordkeeping, dissemination of the order to officers and employees, prior notification to the Commission of corporate changes, notification of new employment, filing of compliance reports, and sunsetting of the order.
The purpose of this analysis is to facilitate public comment on the proposed order, and it is not intended to constitute an official interpretation of the agreement and proposed order or to modify in any way their terms.
By direction of the Commission.
National Institute for Occupational Safety and Health (NIOSH), Department of Health and Human Services (HHS).
Notice.
HHS gives notice of a decision to designate a class of employees from the General Electric Co. in Evendale, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 31, 2011, the Secretary of HHS designated the following class of employees as an addition to the SEC:
All employees of the Department of Energy, its predecessor agencies, and their contractors and subcontractors who worked at General Electric Co. in Evendale, Ohio, from January 1, 1961 through June 30, 1970, for a number of work days aggregating at least 250 work days, occurring either solely under this employment or in combination with work days within the parameters established for one or more other classes of employees included in the Special Exposure Cohort.
This designation will become effective on September 30, 2011, unless Congress provides otherwise prior to the effective date. After this effective date, HHS will publish a notice in the
Stuart L. Hinnefeld, Director, Division of Compensation Analysis and Support, NIOSH, 4676 Columbia Parkway, MS C-46, Cincinnati, OH 45226, Telephone 877-222-7570. Information requests can also be submitted by e-mail to
15 U.S.C. 3719.
Office of the National Coordinator for Health Information Technology, HHS.
Notice.
The “Ensuring Safe Transitions from Hospital to Home” challenge tasks developers with creating technology solutions that empower discharged patients to take charge of their health care during transitions of places of care. Innovative applications will help patients and their caregivers insure that they have all the information and materials, such as drug prescriptions, medical equipment, follow-up appointments, and emergency contacts, that they need to move safely to their next care setting.
The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).
Effective on September 12, 2011.
To be eligible to win a prize under this challenge, an individual or entity:
(1) Shall have registered to participate in the competition under the rules promulgated by Office of the National Coordinator for Health Information Technology;
(2) Shall have complied with all the requirements under this section;
(3) In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States; and
(4) May not be a Federal entity or Federal employee acting within the scope of their employment.
An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.
Registered participants shall be required to agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from their participation in a competition, whether the injury, death, damage, or loss arises through negligence or otherwise.
Participants shall be required to obtain liability insurance or demonstrate financial responsibility, in amounts determined by the head of the Office of the National Coordinator for Health Information Technology, for claims by—
(1) A third party for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in a competition, with the Federal Government named as an additional insured under the registered participant's insurance policy and registered participants agreeing to indemnify the Federal Government against third party claims for damages arising from or related to competition activities; and
(2) the Federal Government for damage or loss to Government property resulting from such an activity.
Participants must be teams of at least two people.
All participants are required to provide written consent to the rules upon or before submitting an entry.
• Submission Period Begins: 12:01 a.m., E.D.T., September 12, 2011.
• Submission Period Ends: 11:59 p.m., E.D.T., November 16, 2011.
To register for this challenge participants should:
• Access the
• Access the ONC Investing in Innovation (i2) Challenge Web site at:
○
○ A registration link for the challenge can be found on the landing page under the challenge description.
• First Prize: $25,000.
• Second Prize: $10,000.
• Third Prize: $5,000.
Awards may be subject to Federal income taxes and HHS will comply with IRS withholding and reporting requirements, where applicable.
The judging panel will make selections based upon the following criteria:
1. Innovation.
2. Usability/Design.
3. Potential for impact.
4. Data integration.
5. Use of NwHIN standards and services.
Ownership of intellectual property is determined by the following:
• Each entrant retains title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement.
• By participating in the challenge, each entrant hereby irrevocably grants to Sponsor and Administrator a limited, non-exclusive, royalty free, worldwide, license and right to reproduce, publically perform, publically display, and use the Submission to the extent necessary to administer the challenge, and to publically perform and publically display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge.
15 U.S.C. 3719.
Office of the National Coordinator for Health Information Technology, HHS.
Notice.
Medical devices will play an increasingly large role in the monitoring and collection of patient data with the spread of electronic health records. The United States has a limited system for the post-market surveillance of medical devices, specifically as it relates to monitoring product safety and effectiveness. The “Reporting Device Adverse Events Challenge” asks multi-disciplinary teams to develop an application that facilitates the reporting of adverse events related to medical devices, whether implanted or used in the hospital, clinic, or home.
The statutory authority for this challenge competition is Section 105 of the America COMPETES Reauthorization Act of 2010 (Pub. L. 111-358).
Effective on September 12, 2011.
To be eligible to win a prize under this challenge, an individual or entity:
(1) Shall have registered to participate in the competition under the rules
(2) Shall have complied with all the requirements under this section;
(3) In the case of a private entity, shall be incorporated in and maintain a primary place of business in the United States, and in the case of an individual, whether participating singly or in a group, shall be a citizen or permanent resident of the United States; and
(4) May not be a Federal entity or Federal employee acting within the scope of their employment.
An individual or entity shall not be deemed ineligible because the individual or entity used Federal facilities or consulted with Federal employees during a competition if the facilities and employees are made available to all individuals and entities participating in the competition on an equitable basis.
Registered participants shall be required to agree to assume any and all risks and waive claims against the Federal Government and its related entities, except in the case of willful misconduct, for any injury, death, damage, or loss of property, revenue, or profits, whether direct, indirect, or consequential, arising from their participation in a competition, whether the injury, death, damage, or loss arises through negligence or otherwise.
Participants shall be required to obtain liability insurance or demonstrate financial responsibility, in amounts determined by the head of the Office of the National Coordinator for Health Information Technology, for claims by—
(1) A third party for death, bodily injury, or property damage, or loss resulting from an activity carried out in connection with participation in a competition, with the Federal Government named as an additional insured under the registered participant's insurance policy and registered participants agreeing to indemnify the Federal Government against third party claims for damages arising from or related to competition activities; and
(2) the Federal Government for damage or loss to Government property resulting from such an activity.
Participants must be teams of at least two people.
All participants are required to provide written consent to the rules upon or before submitting an entry.
• Submission Period Begins: 12:01 a.m., E.D.T., September 12, 2011.
• Submission Period Ends: 11:59 p.m., E.D.T., December 2, 2011.
To register for this challenge participants should:
• Access the
• Access the ONC Investing in Innovation (i2) Challenge Web site at:
○
○ A registration link for the challenge can be found on the landing page under the challenge description.
• First Prize: $25,000.
• Second Prize: $10,000.
• Third Prize: $5,000.
Awards may be subject to Federal income taxes and HHS will comply with IRS withholding and reporting requirements, where applicable.
The judging panel will make selections based upon the following criteria:
1. Effectiveness in facilitating adverse event reporting.
2. Usability and design.
3. Ability to integrate with electronic health records and other data sources.
4. Creativity and Innovation.
5. Use of NwHIN standards and services.
Ownership of intellectual property is determined by the following:
• Each entrant retains title and full ownership in and to their submission. Entrants expressly reserve all intellectual property rights not expressly granted under the challenge agreement.
• By participating in the challenge, each entrant hereby irrevocably grants to Sponsor and Administrator a limited, non-exclusive, royalty free, worldwide, license and right to reproduce, publically perform, publically display, and use the Submission to the extent necessary to administer the challenge, and to publically perform and publically display the Submission, including, without limitation, for advertising and promotional purposes relating to the challenge.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Health Literacy Item Set Supplemental to CAHPS Health Plan Survey—Pretest of Proposed Questions and Methodology.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
This proposed information collection was previously published in the
Comments on this notice must be received by October 17, 2011.
Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by e-mail at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by e-mail at
The Consumer Assessment of Healthcare Providers and Systems (CAHPS®) program is a multi-year initiative. AHRQ first launched the program in October 1995 in response to concerns about the lack of good information about the quality of health plans from the enrollees' perspective. Numerous public and private organizations collected information on
• Make it possible to compare survey results across sponsors and over time; and
• Generate tools and resources that sponsors can use to produce understandable and usable comparative information for consumers, health providers and for quality improvement purposes.
Over time, the program has expanded beyond its original focus on health plans to address a range of health care services and to meet the various needs of health care consumers, purchasers, health plans, providers, and policymakers. Based on a literature review and an assessment of currently available questionnaires, AHRQ identified the need to develop a health literacy module for the CAHPS® Health Plan Survey. The intent of the health literacy module is to examine health plan enrollees' perspectives on how well health information is communicated to them by health plans and by healthcare professionals in the health plan setting. The objective of the new module is to provide information to health plans, clinicians, group practices, and other interested parties regarding the quality of health information delivered to patients. The health literacy module will be pre-tested as a supplement to the CAHPS® Health Plan Survey.
This pre-test has the following goals:
(1) Analysis of item wording—Assess candidate wordings for items.
(2) Analysis of participation rate—Evaluate the overall response rate and the proportion of that obtained from mail versus telephone modes of data collection.
(3) Case mix adjustment analysis—Evaluate variables that need to be considered for case mix adjustment of scores.
(4) Psychometric Analysis—Provide information for the revision of the health literacy item set based on the assessment of the reliability and validity.
(5) Dissemination of the CAHPS Health Plan Health Literacy supplemental item set.
This study is being conducted by AHRQ through its contractor, the RAND Corporation, pursuant to AHRQ's statutory authority to conduct research and evaluations on health care and systems for the delivery of such care, including activities with respect to the quality, effectiveness, efficiency, appropriateness and value of health care services. See 42 U.S.C. 299a(a)(1).
To achieve the goals of this pre-test the CAHPS Health Plan Health Literacy Survey will be implemented with a sample of persons from the surveys' target population, consumers of health care services offered by health plans. The data from this pre-test will be used to refine the health literacy module questions and will ensure that the future data collection yield high quality data and ensure a minimization of respondent burden, increase agency efficiency, and improve responsiveness to the public. The survey items will be added to currently available CAHPS surveys and will enhance the ability of health plans and health professionals working in a health plan primary care setting to assess the quality of their services.
Exhibit 1 shows the estimated annualized burden for the respondents' time to participate in this data collection. About 1000 persons will complete the CAHPS Health Plan Survey Health Literacy Module. The estimated response time of 25 minutes is based on the written length of the survey and AHRQ's experience with previous CAHPS® surveys of comparable length that were fielded with similar samples. The total burden hours are estimated to be 417 hours.
Exhibit 2 shows the respondents' cost burden associated with their time to participate in this data collection. The total cost burden is estimated to be $8,715.
Exhibit 3 shows the total and annualized cost to conduct this research. The total cost for this project is approximately $299,000. Since the data collection period is less than one year, the total and annualized costs are identical.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare 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.
Agency for Healthcare Research and Quality, HHS.
Notice.
This notice announces the intention of the Agency for Healthcare Research and Quality (AHRQ) to request that the Office of Management and Budget (OMB) approve the proposed information collection project: “Medical Expenditure Panel Survey—Insurance Component 2012-2013.” In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.
This proposed information collection was previously published in the
Comments on this notice must be received by October 17, 2011.
Written comments should be submitted to: AHRQ's OMB Desk Officer by fax at (202) 395-6974 (attention: AHRQ's desk officer) or by e-mail at
Copies of the proposed collection plans, data collection instruments, and specific details on the estimated burden can be obtained from the AHRQ Reports Clearance Officer.
Doris Lefkowitz, AHRQ Reports Clearance Officer, (301) 427-1477, or by e-mail at
Employer-sponsored health insurance is the source of coverage for 85 million current and former workers, plus many of their family members, and is a cornerstone of the U.S. health care system. The Medical Expenditure Panel Survey—Insurance Component (MEPS-IC) measures the extent, cost, and coverage of employer-sponsored health insurance on an annual basis. These statistics are produced at the National, State, and sub-State (metropolitan area) level for private industry. Statistics are also produced for State and Local governments.
This research has the following goals:
(1) To provide data for Federal policymakers evaluating the effects of National and State health care reforms;
(2) to provide descriptive data on the current employer-sponsored health insurance system and data for modeling the differential impacts of proposed health policy initiatives; and
(3) to supply critical State and National estimates of health insurance spending for the National Health Accounts and Gross Domestic Product.
This study is being conducted by AHRQ through an interagency agreement with the U.S. Census Bureau and pursuant to AHRQ's statutory authority to conduct surveys to collect data on the cost, use and quality of health care, including the types and costs of private health insurance. 42 U.S.C. 299b-2(a).
To achieve the goals of this project the following data collections for both private sector and state and local government employers will be implemented:
(1) Prescreener Questionnaire—The purpose of the Prescreener Questionnaire, which is collected via telephone, varies depending on the insurance status of the establishment contacted. (Establishment is defined as a single, physical location in the private sector and a governmental unit in state and local governments.) For establishments that do not offer health insurance to their employees, the prescreener is used to collect basic information such as number of employees. Collection is completed for these establishments through this telephone call. For establishments that do offer health insurance, contact name and address information is collected that is used for the mailout of the establishment and plan questionnaires. Obtaining this contact information helps ensure that the questionnaires are directed to the person in the establishment best equipped to complete them.
(2) Establishment Questionnaire—The purpose of the mailed Establishment Questionnaire is to obtain general information from employers that provide health insurance to their employees. Information such as total active enrollment in health insurance, other employee benefits, waiting periods, and retiree health insurance is collected through the establishment questionnaire.
(3) Plan Questionnaire—The purpose of the mailed Plan Questionnaire is to collect plan-specific information on each plan (up to four plans) offered by establishments that provide health insurance to their employees. This questionnaire obtains information on total premiums, employer and employee contributions to the premium, and plan enrollment for each type of coverage offered—single, employee-plus-one, and family—within a plan. It also asks for information on deductibles, copays, and other plan characteristics. This information is needed in order to provide the tools for Federal, State, and academic researchers to evaluate current and proposed health policies and to support the production of important statistical measures for other Federal agencies.
Exhibit 1 shows the estimated annualized burden hours for the respondent's time to provide the requested data. The Prescreener questionnaire will be completed by 31,552 respondents and takes about 5
Exhibit 2 shows the estimated annualized cost burden associated with the respondents' time to participate in this data collection. The annualized cost burden is estimated to be $614,256.
Exhibit 3 shows the estimated annualized cost of this data collection. The total cost over the 2 years of this clearance is $22,954,000.
In accordance with the Paperwork Reduction Act, comments on AHRQ's information collection are requested with regard to any of the following: (a) Whether the proposed collection of information is necessary for the proper performance of AHRQ healthcare research and healthcare information
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.
Food and Drug Administration, HHS; Food Safety and Inspection Service, USDA.
Notice; establishment of dockets; request for comments, data, and information.
The Food and Drug Administration (FDA) and the Food Safety and Inspection Service (FSIS) are announcing the establishment of dockets to obtain comments, data, and evidence relevant to the dietary intake of sodium as well as current and emerging approaches designed to promote sodium reduction. FDA and FSIS are particularly interested in research that will help both organizations understand current and emerging practices by industry in sodium reduction in foods; current consumer understanding of the role of sodium in hypertension and other chronic illnesses, sodium consumption practices; motivation and barriers in reducing sodium in their food intakes; and issues associated with the development of targets for sodium reduction in foods to promote reduction of excess sodium intake. Excess sodium intake is linked to increased risk of heart disease and stroke. FDA and FSIS recognize ongoing efforts by a number of members of the restaurant and packaged food industries to reduce sodium and appreciate the complexities of reducing sodium in foods. Continued input and support from industry and other stakeholders are important to support further progress on this significant public health issue.
Submit either electronic or written comments and data and information by November 29, 2011.
Research shows that excess sodium consumption is a contributory factor in the development of hypertension, which is a leading cause of heart disease and stroke (Ref. 1), the first and fourth leading causes of death in the United States, respectively (Ref. 2). Research also shows that the increase in blood pressure seen with aging, common to most Western countries, is not observed in populations that consume low sodium diets (Refs. 3 and 4) and that the U.S. population consumes far more sodium than recommended (Ref. 5 and 7). Moreover, dietary reduction of sodium can lower blood pressure as has been demonstrated in the Dietary Approaches to Stop Hypertension (DASH)-Sodium trial (Ref. 6). Because over three-quarters of sodium in the diet of the U.S. population is added during manufacturing of foods and preparation of restaurant foods, reduction in sodium consumption in the United States involves reduction in the sodium content of food in the U.S. marketplace (Refs. 5 and 7).
In this document, we refer primarily to “sodium,” a component of sodium chloride, commonly known as “salt.” Most but not all sodium is added to food in the form of salt and we are interested in all sources of sodium added to foods. The comments, data, and evidence regarding sodium reduction obtained by the establishment of these dockets will provide important information about current and emerging practices and approaches designed to reduce excess sodium intake, primarily coming from salt.
According to national food survey data from the “What We Eat in America, National Health and Nutrition Examination Survey (NHANES) 2007-2008,” estimated average sodium intake from foods among persons in the United States aged 2 years or older is approximately 3,300 milligrams per day (mg/d) (excluding salt added at the table) (Ref. 8). Most of this sodium comes from salt used in the manufacture or preparation of foods (Ref. 9). In 2005, the IOM set a Tolerable Upper Intake Level (UL) for sodium at 2,300 mg/d and an Adequate Intake (AI) at 1,500 mg/d for those 9 to 50 years of age, including pregnant and lactating women (AIs are lower for those 0-8 years of age and for those over 50 years of age) (Ref. 1). The 2010 Dietary Guidelines for Americans recommendations are to “reduce daily sodium intake to less than 2,300 milligrams (mg) and further reduce intake to 1,500 mg among persons who are 51 and older and those of any age who are African American or have hypertension, diabetes, or chronic kidney disease.” The 1,500 mg recommendation applies to about half of the U.S. population (Ref. 7). Current sodium intake is substantially higher
The 2010 Dietary Guidelines for Americans also stated that “Given the current U.S. marketplace and the resulting excessive high sodium intake, it is challenging to meet even the less than 2,300 mg recommendation” and that a concerted effort is needed to reduce sodium in foods to help consumers meet the levels recommended (Ref. 7).
An analysis of the potential savings from reduced sodium consumption in the U.S. adult population found that reducing average dietary sodium intake to 2,300 mg/d among adults 18 years or older could have substantial health and financial benefits. Estimates showed potential reduction of 11 million hypertension cases and an annual savings of $18 billion health care costs (Ref. 11). Another assessment on the cost-effectiveness of reducing sodium intake found that an intervention achieving a reduction of 1,200 mg/d would save $10 to $24 billion in health care costs annually, comparable to benefits of population-wide reductions in tobacco use, obesity, and cholesterol levels (Ref. 12). Furthermore, this analysis found that a modest reduction over 10 years of about 400 mg sodium/d would be more cost-effective than using medications to lower blood pressure in all persons with hypertension (Ref. 12).
Since 1980, the U.S. Department of Agriculture (USDA) and the U.S. Department of Health and Human Services (HHS) have made recommendations in the Dietary Guidelines for Americans, including “avoid too much sodium,” “use salt and sodium only in moderation,” and “choose and prepare foods with less salt” (Refs. 7 and 13 through 17).
FDA has supported these recommendations with a variety of initiatives designed to promote informed choices on the part of consumers. In 1984, FDA required that information on sodium be included on the label whenever nutrition information appeared on food labels (49 FR 15510, April 18, 1984). In 1990, Congress enacted the Nutrition Labeling and Education Act (NLEA), which mandated nutrition labeling of food. In response to the NLEA, in 1993 FDA issued regulations requiring the declaration of sodium in absolute amounts and as a percentage of the Daily Value (58 FR 2206, January 6, 1993). FDA has also established standards for sodium-related nutrient content and health claims (
FSIS, the agency responsible for nutrition labeling requirements for meat and poultry products, also coordinates and collaborates with FDA on nutrition labeling issues. In 1993, FSIS issued regulations establishing nutrition labeling requirements for meat and poultry products (9 CFR 317, part 381, subpart Y). These regulations, similar to FDA's nutrition labeling regulations, required the declaration of sodium in absolute amounts and as a percentage of the Daily Value on the labeling of nonexempted meat and poultry products. In December 2010, FSIS issued regulations to ensure nutrition labeling of the major cuts of single-ingredient, raw meat and poultry products on labels or at point-of-purchase, unless an exemption applies (75 FR 82148, December 29, 2010). These regulations also require nutrition labels on all ground or chopped meat and poultry products, with or without added seasonings, unless an exemption applies. Thus, these regulations increase the type of meat and poultry products that must declare sodium in absolute amounts and as a percentage of the Daily Value in their labeling.
Other U.S. public health agencies and organizations have also sought to inform consumers and encourage reduced sodium intake. In addition to conveying the benefits of reducing sodium related to hypertension through professional and consumer education activities, the NHLBI published guidelines recommending a sodium intake of no more than 2,400 mg/d dating back to 1993 (Refs. 20 through 26). More recently, the CDC has provided funding to various states and communities across the country in support of sodium reduction efforts to help create healthier food environments and reduce sodium intake by the population (Ref. 27). In addition, USDA, through the nutrition programs of the Center for Nutrition Policy and Promotion, promotes consumer messages related to sodium reductions via the interactive, web-based dietary assessment and weight management resources at ChooseMyPlate.gov, as well as through its MyPlate 2010 Dietary Guidelines for Americans consumer communications initiative and Consumer Brochure.
In 2008, the New York City Department of Health and Mental Hygiene initiated the National Sodium Reduction Initiative (NSRI), a partnership of 70 local and state health departments and health organizations, which has set targets to reduce sodium in restaurant and processed foods (Ref. 28). The goal of NSRI is to decrease average sodium intake by 20 percent over 5 years (2009 through 2014) by developing stepwise reductions from 2009 base levels to those desired by 2014. To-date, 28 companies have responded to NSRI, committing to reductions in the sodium content of some of their products.
These initiatives have been accompanied by efforts by industry, where a number of companies have played, and continue to play, a leadership role. Many food companies recognize that reduction of sodium in the American diet is an important public health issue. Some major food manufacturers have publicly committed to reducing the sodium content of their products over time. Certain companies have voluntarily identified specific product goals for sodium reduction. Many have demonstrated that substantial reductions in sodium can be achieved in certain food products and have established research programs to address key issues such as taste preference, technological advances, safety, and consumer acceptance in working through challenges and gaps in knowledge.
Other countries are also engaged in sodium reduction activities (Refs. 29 and 30).
In April 2010, the IOM released a report entitled “Strategies to Reduce Sodium Intake in the United States.” The report concluded that sodium intake, with the greatest contribution from salt, remains well above recommended levels despite several decades of education, labeling, and outreach efforts to reduce sodium consumption in the United States (Ref. 5). In the report, the committee considered past and current sodium reduction initiatives, consumer preference, the functional roles of sodium in food, research needs, regulatory options, and nutrition labeling in developing its recommendations. The IOM report acknowledged a number of complicating factors in reducing sodium in food. Although sodium primarily plays a role in altering taste, the IOM report noted that sodium chloride and other sodium-containing ingredients play a critical role in food safety by reducing the growth of pathogens thereby improving safety and shelf-life. In addition, these compounds provide functional and physical properties such as improving texture, controlling stickiness, and improving meltability. Among other things, the IOM report noted that more research is needed to develop and implement new technologies for sodium reduction and discussed the role of voluntary action by industry.
According to data presented to the IOM committee during the March 2009 public information gathering workshop (see Appendix L of the IOM Sodium Report), approximately 75 percent of the total sodium intake for most individuals is attributed to salt added as an ingredient or processing aid to processed and restaurant foods (Ref. 5). Sodium in the form of salt is added to food for many reasons. For example, salt functions as a seasoning agent and flavor-enhancer, a preservative and curing agent, a formulating and processing aid, and a dough conditioner (Ref. 5). Salt added at the table and in cooking provides only a small proportion of the total sodium that Americans consume (Ref. 9). A number of other sodium-containing ingredients contribute to sodium intake in lesser amounts (<1 percent) (Ref. 31). Some examples include sodium alginate, which alters viscosity; sodium phosphates, which bind liquid to reduce purge, in particular for solution-enhanced meat and poultry products; sodium sulfite, sodium nitrite, and sodium benzoate, which preserve food and inhibit microbial growth; and sodium lactate, diacetate, and acetate, which are dual purpose for flavoring and antimicrobial (pathogen reduction) purposes (Ref. 32). Non-sodium forms of these ingredients, which replace sodium with compounds such as potassium, calcium, and magnesium, are also available for some of these applications (Ref. 31).
According to the National Cancer Institute (NCI), individual and mixed foods contributing the highest proportion of sodium to the U.S. diet include yeast breads (250 mg/d), chicken and chicken mixed dishes (233 mg/d), pizza (217 mg/d), pasta and pasta dishes (174 mg/d), and cold cuts (155 mg/d) (Ref. 33). The CDC reported that close to 40 percent of daily sodium intake comes from grain-based products, such as breads, cakes, cookies, and crackers, and that almost 30 percent comes from processed meat products, such as bacon, sausage, lunch meat, poultry, and fish mixtures (Ref. 10). Sodium occurs naturally in nearly all foods; however this intrinsic sodium is not a significant dietary contributor for most Americans. Essentially, any single-ingredient food is low in sodium.
FDA and FSIS are considering potential ways to promote gradual, achievable and sustainable reduction of sodium intake over time. Research on a variety of issues, including the development of possible targets for the reduction of the sodium content of foods, is needed to assist FDA and FSIS in this effort. Sodium-containing food ingredients are used for multiple purposes at variable levels in diverse foods. The sodium intake of the U.S. population reflects both the sodium levels of individual foods and the amounts of foods consumed. As such, there are a variety of factors that may inform judgments about appropriate opportunities for sodium reduction. These factors include:
1. The important role that sodium has in food safety with respect to limiting microbial growth and maintaining the shelf-life of some foods;
2. The effect of sodium reduction on the physical attributes (
3. The feasibility, practicality, and cost of reducing sodium in various food categories;
4. The magnitude (time and percent sodium reduction) of any gradual or stepwise reduction effort;
5. The need to act gradually in a manner that is acceptable to consumers, while also achieving significant sodium reduction, because taste preference for sodium is acquired and can be modified (Refs. 34 and 35).
FDA and FSIS are establishing dockets to provide an opportunity for interested persons to submit comments, research, data, and other information that will better inform them about current and emerging practices by the private sector in sodium reduction; current consumer understanding of the role of sodium in hypertension and other chronic illnesses; sodium consumption practices; motivation and barriers in reducing sodium in their food intakes; and issues associated with the development of targets for sodium reduction in foods to promote reduction in excess sodium intake. In particular, both agencies welcome input on the following matters:
1. Comments and research related to recent sodium reduction initiatives by industry and the effects of those initiatives;
2. Comments and research related to consumer understanding of the role of sodium in hypertension and other chronic illnesses, sodium consumption practices, and motivation and barriers in reducing sodium in their food intakes;
3. Comments and research related to effective strategies for sustainable and meaningful reduction of sodium in foods sold in packaged or prepared form across the food supply, including and in particular foods with a high sales volume;
4. Comments and research related to existing or potential positive incentives for innovation in reformulating packaged and restaurant foods to reduce added sodium;
5. Comments and research related to the recommendations from the April 2010 IOM Sodium report on “Strategies to Reduce Sodium Intake in the United States,” including research related to information gaps identified in the IOM report (taste preferences for sodium, technological role of sodium/salt, role of food matrix, food safety,
6. Comments and research related to the following: (a) Methods for establishing sodium reduction targets, including information on general target design (
7. Comments and research related to avoiding potential unintended consequences for food safety, nutrition (including effects on added sugars or solid fats), or food manufacturing technologies that could result from interventions to reduce sodium;
8. Comments and research related to existing voluntary sodium reduction efforts, including the voluntary sodium reduction targets set by the New York City-initiated NSRI partnership, and their applicability to a potentential federal sodium reduction initiative;
9. Comments and research related to food formulation, processing, production, and other technology that could lead to meaningful and sustainable reductions in the amount of sodium in food, including specific food categories, targets, and methods to monitor;
10. Comments and research on the role that food standards of identity play in promoting or limiting the feasibility of sodium reduction of foods (among other things, standards of identity for certain foods define the nature of those foods, generally in terms of how those foods are prepared, the types of ingredients that they must contain (
11. Comments and research on any advantages of sodium to consumers, including but not limited to, food safety, nutrition, and palatability;
12. Comments and research on the economic impacts of reducing sodium, including but not limited to, the cost of food, agricultural production, small businesses, jobs, and the health care system;
13. Comments and research on the impact of sodium reduction initiatives on consumer food choices and compliance with 2010 Dietary Guidelines for Americans recommendations;
14. Comments and research related to how consumers respond to sodium reductions (
15. Comments and research related to effective methods for communicating to the public the health benefits associated with the sodium intake levels recommended by the 2010 Dietary Guidelines for Americans.
We anticipate that some interested persons may wish to provide FDA and FSIS with certain comments, research, data, and information that they consider to be trade secret or confidential commercial information (CCI) that would be exempt under Exemption 4 of the Freedom of Information Act (5 U.S.C. 552). You may claim information that you submit to FDA and FSIS as CCI or trade secret by clearly marking both the document and the specific information as “confidential.” Information so marked will not be disclosed except in accordance with the Freedom of Information Act (5 U.S.C. 552) and the specific agency's disclosure regulations (FDA's regulations under 21 CFR part 20; FSIS's regulations under 9 CFR part 390). For electronic submissions to
A
Because two docket numbers are associated with this document, please include with your comments the docket number that corresponds with the appropriate agency. Comments submitted for inclusion in both dockets should be separately submitted to each identified docket number to ensure consideration.
FDA has placed the following references on display in FDA's Division of Dockets Management (see
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (#205) entitled “Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study To Determine the Quantity and Identify the Nature of Residues (MRK),” (VICH GL46). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommendations for internationally harmonized test procedures to study the quantity and nature of residues of veterinary drugs in food-producing animals.
Submit either electronic or written comments on Agency guidances at any time.
Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the
Submit electronic comments on the guidance to
Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8204,
FDA is announcing the availability of a guidance for industry (#205) entitled “Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Metabolism Study To Determine the Quantity and Identify the Nature of Residues (MRK)” (VICH GL46). In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission, European Medicines Evaluation Agency, European Federation of Animal Health, Committee on Veterinary Medicinal Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries.
Four observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings.
In the
This VICH guidance document is one of a series developed to facilitate the mutual acceptance by national/regional regulators of residue chemistry data for veterinary drugs used in food-producing animals. This guidance was prepared after consideration of the current national/regional requirements and recommendations for evaluating veterinary drug residues in the European Union, Japan, the United States, Australia, New Zealand, and Canada.
Although this guidance recommends a framework for metabolism testing, it is important that the design of the studies remains flexible. It is recommended that studies be tailored to sufficiently characterize the components of the residue of concern.
The human food safety evaluation of veterinary drug residues helps ensure that food derived from treated food-producing animals is safe for human consumption. As part of the data collection process, studies should be conducted to permit an assessment of the quantity and nature of residues in food derived from animals treated with a veterinary drug. These metabolism studies provide data on: (1) The depletion of residues of concern from edible tissues of treated animals at varying times after drug administration; (2) the individual components, or residues, that comprise the residue of concern in edible tissues; (3) the residue(s) that can serve as marker for analytical methods intended for compliance purposes (
This guidance, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents must not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement.
This guidance represents the Agency's current thinking on this topic. 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.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in this guidance have been approved under OMB control number 0910-0032.
Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (#207) entitled “Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods,” (VICH GL48). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to fulfill the national/regional requirements.
Submit either electronic or written comments on Agency guidances at any time.
Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the
Submit electronic comments on the guidance to
Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8204,
FDA is announcing the availability of a guidance for industry (#207) entitled “Guidance for Industry on Studies To Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Marker Residue Depletion Studies To Establish Product Withdrawal Periods,” (VICH GL48). In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission, European Medicines Evaluation Agency, European Federation of Animal Health, Committee on Veterinary Medicinal Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries.
Four observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings.
In the
This VICH guidance document is one of a series developed to facilitate the mutual acceptance by national/regional regulators of residue chemistry data for veterinary drugs used in food-producing animals. This guidance was prepared after consideration of the current national/regional requirements and recommendations for evaluating veterinary drug residues in the European Union, Japan, the United States, Australia, New Zealand, and Canada.
As part of the approval process for veterinary medicinal products in food-producing animals, national/regional regulatory authorities require data from marker residue depletion studies in order to establish appropriate withdrawal periods in edible tissues, including meat, milk, and eggs. The objective of this guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated residue depletion data to
This guidance, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents must not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement.
This guidance represents the Agency's current thinking on this topic. 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 applicable statutes and regulations.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in this guidance have been approved under OMB control number 0910-0032.
Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (#206) entitled “Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals” (VICH GL47). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide recommendations for internationally harmonized procedures to identify the metabolites of veterinary drugs produced by laboratory animals used for toxicological testing for the purpose of comparison to the residues of veterinary drugs in edible tissues of food-producing animals.
Submit either electronic or written comments on Agency guidances at any time.
Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the
Submit electronic comments on the guidance to
Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8204,
FDA is announcing the availability of a guidance for industry (#206) entitled “Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Comparative Metabolism Studies in Laboratory Animals” (VICH GL47). In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission, European Medicines Evaluation Agency, European Federation of Animal Health, Committee on Veterinary Medicinal Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries.
Four observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of
In the
This VICH guidance document is one of a series developed to facilitate the mutual acceptance by national/regional regulators of residue chemistry data for veterinary drugs used in food-producing animals. This guidance was prepared after consideration of the current national/regional requirements and recommendations for evaluating veterinary drug residues in the European Union, Japan, the United States, Australia, New Zealand, and Canada.
The objective of this guidance is to provide recommendations for internationally harmonized procedures to identify the metabolites of veterinary drugs produced by laboratory animals. The purpose of the comparative metabolism studies is to compare the metabolites of the animals used for toxicological testing to the residues of the veterinary drugs in edible tissues of food-producing animals in order to determine if the laboratory animals used for toxicological testing have been exposed to the metabolites that humans can be exposed to as residues in products of food-producing animal origin.
The human food safety evaluation of veterinary drug residues helps ensure that food derived from treated food-producing animals is safe for human consumption. As part of the data collection process, studies should be conducted to characterize the metabolites to which laboratory animals are auto-exposed during the toxicological testing of the veterinary drug. The purpose of these studies is to determine whether the metabolites that people will consume from tissues of target food-producing animals are also produced by metabolism in the laboratory animals used for the safety testing.
This guidance, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents must not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement.
This guidance represents the Agency's current thinking on this topic. 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.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in this guidance have been approved under OMB control number 0910-0032.
Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry (#208) entitled “Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies,” (VICH GL49). This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This VICH guidance document is intended to provide a general description of the criteria that have been found by the European Union, Japan, the United States, Australia, New Zealand, and Canada to be suitable for the validation of analytical methods used in veterinary drug residue depletion studies.
Submit either electronic or written comments on Agency guidances at any time.
Submit written requests for single copies of the guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the
Submit electronic comments on the guidance to
Julia Oriani, Center for Veterinary Medicine (HFV-151), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-276-8204,
FDA is announcing the availability of a guidance for industry (#208) entitled “Guidance for Industry on Studies to Evaluate the Metabolism and Residue Kinetics of Veterinary Drugs in Food-Producing Animals: Validation of Analytical Methods Used in Residue Depletion Studies,” (VICH GL49). In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission, European Medicines Evaluation Agency, European Federation of Animal Health, Committee on Veterinary Medicinal Products, the U.S. FDA, the U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries.
Four observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings.
In the
This VICH guidance document is one of a series developed to facilitate the mutual acceptance by national/regional regulators of residue chemistry data for veterinary drugs used in food-producing animals. This guidance was prepared after consideration of the current national/regional requirements and recommendations for evaluating veterinary drug residues in the European Union, Japan, the United States, Australia, New Zealand, and Canada.
During the veterinary drug development process, residue depletion studies are conducted to determine the concentration of the residue or residues present in the edible products (tissues, milk, eggs, or honey) of animals treated with veterinary drugs. This information is used in regulatory submissions around the world. Submission of regulatory methods (
This guidance, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents must not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement.
This guidance represents the Agency's current thinking on this topic. 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.
This guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in
Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the guidance at either
Food and Drug Administration, HHS.
Notice.
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry (#214) entitled “Draft Guidance for Industry, Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data” (VICH GL35). This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This draft VICH guidance document is intended to provide recommended standards to construct a single electronic message to transmit data elements for submission of adverse event reports (AERs) to all member regions.
Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit written or electronic comments on the draft guidance by November 14, 2011.
Submit written requests for single copies of the draft guidance to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your request. See the
Submit electronic comments on the draft guidance to
Margarita Brown, Center for Veterinary Medicine (HFV-240), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 240-276-9048, e-mail:
FDA is announcing the availability of a draft guidance for industry (#214) entitled “Draft Guidance for Industry, Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data (VICH GL35).” In recent years, many important initiatives have been undertaken by regulatory authorities and industry associations to promote the international harmonization of regulatory requirements. FDA has participated in efforts to enhance harmonization and has expressed its commitment to seek scientifically based harmonized technical procedures for the development of pharmaceutical products. One of the goals of harmonization is to identify and then reduce differences in technical requirements for drug development among regulatory agencies in different countries.
FDA has actively participated in the International Conference on Harmonisation of Technical Requirements for Approval of Pharmaceuticals for Human Use for several years to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.
The VICH Steering Committee is composed of member representatives from the European Commission, European Medicines Evaluation Agency, European Federation of Animal Health, Committee on Veterinary Medicinal Products, U.S. FDA, U.S. Department of Agriculture, the Animal Health Institute, the Japanese Veterinary Pharmaceutical Association, the Japanese Association of Veterinary Biologics, and the Japanese Ministry of Agriculture, Forestry, and Fisheries.
Four observers are eligible to participate in the VICH Steering Committee: One representative from the government of Australia/New Zealand, one representative from the industry in Australia/New Zealand, one representative from the government of Canada, and one representative from the industry of Canada. The VICH Secretariat, which coordinates the preparation of documentation, is provided by the International Federation for Animal Health (IFAH). An IFAH representative also participates in the VICH Steering Committee meetings.
The VICH Steering Committee held a meeting in June 2010, and agreed that the draft guidance document entitled “Draft Guidance for Industry on Pharmacovigilance of Veterinary Medicinal Products: Electronic Standards for Transfer of Data” (VICH GL35) should be made available for public comment. This draft VICH guidance document is intended to provide recommended standards to construct a single electronic message to transmit data elements for submission of AERs to all member regions.
The need to transfer and disseminate information quickly, accurately and easily between Regulatory Authorities (RA) and Marketing Authorization Holders (MAH) on a worldwide scope is especially pertinent to the notification and assimilation of information for pharmacovigilance. Whereas the recommended definition of the pharmacovigilance information has
In order to allow for electronic exchange of this information between stakeholders, further specification of the field descriptors and their relationships, including agreement on format of the electronic message is essential.
FDA and the VICH Expert Working Group will consider comments about the draft guidance document.
This draft guidance refers to previously approved collections of information found in FDA regulations. These collections of information are subject to review by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of information in this guidance have been approved under OMB Control No. 0910-0284.
This draft guidance, developed under the VICH process, has been revised to conform to FDA's good guidance practices regulation (21 CFR 10.115). For example, the document has been designated “guidance” rather than “guideline.” In addition, guidance documents must not include mandatory language such as “shall,” “must,” “require,” or “requirement,” unless FDA is using these words to describe a statutory or regulatory requirement.
The draft guidance, when finalized, will represent the agency's current thinking on this topic. 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 applicable statutes and regulations.
Interested persons may submit to the Division of Dockets Management (see
Persons with access to the Internet may obtain the draft guidance at either
Pursuant to section 10(d) of the
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(a) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Sickle Cell Disease Advisory Committee.
The meeting will be open to the public, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NIA.
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute on Aging, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meeting.
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the
The meetings will be closed to the public in accordance with the provisions set forth in sections552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and thediscussions could disclose confidential trade secrets or commercial property such as patentablematerial, and personal information concerning individuals associated with the grant applications,the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications,the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is
The meeting will be open to the public as indicated below, with attendance limited to space available. Individuals who plan to attend and need special assistance, such as sign language interpretation or other reasonable accommodations, should notify the Contact Person listed below in advance of the meeting.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Institute of Environmental Health Sciences, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Any interested person may file written comments with the committee by forwarding the statement to the Contact Person listed on this notice. The statement should include the name, address, telephone number and when applicable, the business or professional affiliation of the interested person.
Pursuant to section 10(d) of the
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of a meeting of the Board of Scientific Counselors, NHLBI.
The meeting will be closed to the public as indicated below in accordance with the provisions set forth in section 552b(c)(6), Title 5 U.S.C., as amended for the review, discussion, and evaluation of individual intramural programs and projects conducted by the National Heart, Lung, and Blood Institute, including consideration of personnel qualifications and performance, and the competence of individual investigators, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Information is also available on the Institute's/Center's home page:
Pursuant to section 10(d) of the Federal Advisory Committee Act, as amended (5 U.S.C. App.), notice is hereby given of the following meetings.
The meetings will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable material, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
Pursuant to section 10(d) of the
The meeting will be closed to the public in accordance with the provisions set forth in sections 552b(c)(4) and 552b(c)(6), Title 5 U.S.C., as amended. The grant applications and the discussions could disclose confidential trade secrets or commercial property such as patentable materials, and personal information concerning individuals associated with the grant applications, the disclosure of which would constitute a clearly unwarranted invasion of personal privacy.
September 26, 2011, 9 a.m.-1:30 p.m.
901 N. Stuart Street, Tenth Floor, Arlington, Virginia 22203.
Open session.
• Approval of the Minutes of the June 6, 2011, Meeting of the Board of Directors
• Strategic Planning
• President and Management Report
• Communications Strategy
• Advisory Council
• Next Meetings
• Approval of the Minutes of the June 6, 2011, Meeting of the Board of Directors
• Strategic Planning
• President and Management Report
• Communications Strategy
• Advisory Council
• Next Meetings
• None
Jennifer Hodges Reynolds, General Counsel, (703) 306-0002.
Office of the Secretary, Interior.
Notice.
This notice lists programs or portions of programs that are eligible for inclusion in Fiscal Year 2012 funding agreements with self-governance Indian tribes and lists programmatic targets for each of the non-Bureau of Indian Affairs (BIA) bureaus in the Department of the Interior, pursuant to the Tribal Self-Governance Act.
This notice expires on September 30, 2012.
Inquiries or comments regarding this notice may be directed to Sharee M. Freeman, Director, Office of Self-Governance (MS 355H-SIB), 1849 C
Title II of the Indian Self-Determination Act Amendments of 1994 (Pub. L. 103-413, the “Tribal Self-Governance Act” or the “Act”) instituted a permanent self-governance program at the Department of the Interior. Under the self-governance program, certain programs, services, functions, and activities, or portions thereof, in Interior bureaus other than BIA are eligible to be planned, conducted, consolidated, and administered by a self-governance tribal government.
Under section 405(c) of the Tribal Self-Governance Act, the Secretary of the Interior is required to publish annually: (1) A list of non-BIA programs, services, functions, and activities, or portions thereof, that are eligible for inclusion in agreements negotiated under the self-governance program; and (2) programmatic targets for these bureaus.
Under the Tribal Self-Governance Act, two categories of non-BIA programs are eligible for self-governance funding agreements:
(1) Under section 403(b)(2) of the Act, any non-BIA program, service, function or activity that is administered by Interior that is “otherwise available to Indian tribes or Indians,” can be administered by a tribal government through a self-governance funding agreement. The Department interprets this provision to authorize the inclusion of programs eligible for self-determination contracts under Title I of the Indian Self-Determination and Education Assistance Act (Pub. L. 93-638, as amended). Section 403(b)(2) also specifies, “nothing in this subsection may be construed to provide any tribe with a preference with respect to the opportunity of the tribe to administer programs, services, functions and activities, or portions thereof, unless such preference is otherwise provided for by law.”
(2) Under section 403(c) of the Act, the Secretary may include other programs, services, functions, and activities or portions thereof that are of “special geographic, historical, or cultural significance” to a self-governance tribe.
Under section 403(k) of the Tribal Self-Governance Act, funding agreements cannot include programs, services, functions, or activities that are inherently Federal or where the statute establishing the existing program does not authorize the type of participation sought by the tribe. However, a tribe (or tribes) need not be identified in the authorizing statutes in order for a program or element to be included in a self-governance funding agreement. While general legal and policy guidance regarding what constitutes an inherently Federal function exists, the Secretary will determine whether a specific function is inherently Federal on a case-by-case basis considering the totality of circumstances.
Subpart G of the self-governance regulations found at 25 CFR part 1000 provides the process and timelines for negotiating self-governance funding agreements with non-BIA bureaus.
Comments were received from two Tribal entities (Coquille Indian Tribe and Council of Athabascan Tribal Governments) and two Federal entities (National Park Service and U.S. Fish and Wildlife Service).
The Coquille Indian Tribe suggested the following: (1) Revising Section I. Background [next to the last paragraph] to indicate that the Secretary (not each non-BIA bureau) will determine whether a specific function is inherently Federal on a case-by-case basis considering the totality of circumstances. This change was made; (2) Revising Section III. A. Eligible Bureau of Land Management (BLM) Programs [Other Activities paragraph] to change the title of Item 2. to Natural Resources Management (from Forestry Management) and insert silvicultural treatments, timber management, cultural resource management, watershed restoration as additional activities. This change was made; (3) Revising Section III. A. Eligible Bureau of Land Management (BLM) Programs [Other Activities paragraph] to insert implementation of statutory, regulatory and policy or administrative plan-based species protection efforts as additional activities to Item 6. Wildlife and Fisheries Habitat Management. This change was made; (4) Add the Administration of Forest Management Deductions as a third program to Section III. G. Eligible Office of the Special Trustee for American Indians (OST) Programs. This change was not made. This is a decision beyond the authority of the Office of the Special Trustee for American Indians to make.
The Council of Athabascan Tribal Governments suggested the following: (1) Listing the Council of Athabascan Tribal Governments in Section II. as having a Self-Governance Funding Agreement with the Bureau of Land Management. This change was made; and (2) Keep Subsistence Programs within the State of Alaska in the final
The National Park Service suggested adding the following three Parks to the National Park Service section listing Locations of National Park Service Units with Close Proximity to Self-Governance Tribes: (1) Isle Royale National Park—Michigan; (2) Great Smoky Mountains National Park—North Carolina/Tennessee; and (3) Yosemite National Park—California. These changes were made.
The Fish and Wildlife Service suggested adding the following three Refuges to the Fish and Wildlife Service section listing Locations of Refuges and Hatcheries with Close Proximity to Self-Governance Tribes: (1) National Bison Range—Montana; (2) Ninepipe National Wildlife Refuge—Montana; and (3) Pablo National Wildlife Refuge—Montana. These changes were made.
Below is a listing by bureau of the types of non-BIA programs, or portions thereof, that may be eligible for self-governance funding agreements because
The Department will also consider for inclusion in funding agreements other programs or activities not listed below, but which, upon request of a self-governance tribe, the Department determines to be eligible under either sections 403(b)(2) or 403(c) of the Act. Tribes with an interest in such potential agreements are encouraged to begin discussions with the appropriate non-BIA bureau.
The BLM carries out some of its activities in the management of public lands through contracts and cooperative agreements. These and other activities, dependent upon availability of funds, the need for specific services, and the self-governance tribe demonstrating a special geographic, culture, or historical connection, may also be available for inclusion in self-governance funding agreements. Once a tribe has made initial contact with the BLM, more specific information will be provided by the respective BLM State office.
Some elements of the following programs may be eligible for inclusion in a self-governance funding agreement. This listing is not all-inclusive, but is representative of the types of programs that may be eligible for tribal participation through a funding agreement.
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For questions regarding self-governance, contact Jerry Cordova, Bureau of Land Management (20 M St. WS-5242), 1849 C Street, NW., Washington, DC 20240, telephone: (202) 912-7245, fax: (202) 452-7701.
The mission of the Bureau of Reclamation (Reclamation) is to manage, develop, and protect water and related resources in an environmentally and economically sound manner in the interest of the American public. To this end, most of the Reclamation's activities involve the construction, operation and maintenance, and management of water resources projects and associated facilities, as well as research and development related to its responsibilities. Reclamation water resources projects provide water for agricultural, municipal and industrial water supplies; hydroelectric power generation; flood control; outdoor recreation; and enhancement of fish and wildlife habitats.
Components of the following water resource projects listed below may be eligible for inclusion in a self-governance annual funding agreement. This list was developed with consideration of the proximity of identified self-governance tribes to Reclamation projects.
1. Klamath Project, California and Oregon.
2. Trinity River Fishery, California.
3. Central Arizona Project, Arizona.
4. Rocky Boy's/North Central Montana Regional Water System, Montana.
5. Indian Water Rights Settlement Projects, as authorized by Congress.
Upon the request of a self-governance tribe, Reclamation will also consider for inclusion in funding agreements, other programs or activities which Reclamation determines to be eligible under Section 403(b)(2) or 403(c) of the Act.
For questions regarding self-governance, contact Mr. Douglas Oellermann, Deputy Director, Native American and International Affairs Office, Bureau of Reclamation (96-43000) (MS 7069-MIB); 1849 C Street, NW., Washington, DC 20240, telephone: (202) 513-0560, fax: (202) 513-0311.
Effective October 1, 2010, the Minerals Revenue Management program moved from the Bureau of Ocean Energy Management (formerly MMS) to the Office of the Assistant Secretary for Policy, Management and Budget (PMB) and became the Office of Natural Resources Revenue (ONRR). The ONRR collects, accounts for, and distributes mineral revenues from both Federal and Indian mineral leases.
The ONRR also evaluates industry compliance with laws, regulations, and lease terms, and offers mineral-owning tribes opportunities to become involved in its programs that address the intent of tribal self-governance. These programs are available regardless of self-governance intentions or status and are a good prerequisite for assuming other technical functions. Generally, ONRR program functions are available to tribes because of the Federal Oil and Gas Royalty Management Act of 1983 (FOGRMA) at 30 U.S.C. 1701. The ONRR program functions that may be available to self-governance tribes include:
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For questions regarding self-governance contact Shirley M. Conway, Special Assistant to the Director, Office of Natural Resources Revenue, Office of the Assistant Secretary—Policy, Management and Budget—1801 Pennsylvania Ave., NW., 4th Floor, 403D, Washington, DC 20006, telephone: (202) 254-5554, fax: (202) 254-5589.
The National Park Service administers the National Park System, which is made up of national parks, monuments, historic sites, battlefields, seashores, lake shores and recreation areas. The National Park Service maintains the park units, protects the natural and cultural resources, and conducts a range of visitor services such as law enforcement, park maintenance, and interpretation of geology, history, and natural and cultural resources.
Some elements of the following programs may be eligible for inclusion in a self-governance funding agreement. This list below was developed considering the proximity of an identified self-governance tribe to a national park, monument, preserve, or recreation area and the types of programs that have components that may be suitable for contracting through a self-governance funding agreement. This list is not all-inclusive, but is representative of the types of programs which may be eligible for tribal participation through funding agreements.
For questions regarding self-governance, contact Dr. Patricia Parker, Chief, American Indian Liaison Office, National Park Service (Org. 2560, 9th Floor), 1201 Eye Street, NW., Washington, DC 20005-5905, telephone: (202) 354-6962, fax: (202) 371-6609.
The mission of the U.S. Fish & Wildlife Service is, working with others to conserve, protect, and enhance fish, wildlife, and plants and their habitats for the continuing benefit of the American people. Primary responsibilities are for migratory birds, endangered species, freshwater and anadromous fisheries, and certain marine mammals. The Service also has a continuing cooperative relationship with a number of Indian tribes throughout the National Wildlife Refuge System and the Service's fish hatcheries. Any self-governance tribe may contact a National Wildlife Refuge or National Fish Hatchery directly concerning participation in Service programs under the Tribal Self-Governance Act. This list is not all-inclusive, but is representative of the types of Service programs that may be eligible for tribal participation through an annual funding agreement.
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The Service developed the list below based on the proximity of identified self-governance tribes to Service facilities that have components that may be suitable for contracting through a self-governance funding agreement.
For questions regarding self-governance, contact Patrick Durham, Fish and Wildlife Service (MS-330), 4401 N. Fairfax Drive, Arlington, VA 22203, telephone: (703) 358-1728, fax: (703) 358-1930.
The mission of the USGS is to collect, analyze, and provide information on biology, geology, hydrology, and geography that contributes to the wise management of the Nation's natural resources and to the health, safety, and well-being of the American people. This information is usually publicly available and includes maps, data bases, and descriptions and analyses of the water, plants, animals, energy, and mineral resources, land surface, underlying geologic structure, and dynamic
For questions regarding self-governance, contact Monique Fordham, National Tribal Liaison, U.S. Geological Survey, 12201 Sunrise Valley Drive, Mail Stop 911, Reston, VA 20192, telephone 703-648-4437, fax 703-648-6683.
The Department of the Interior has responsibility for what may be the largest land trust in the world, approximately 56 million acres. OST oversees the management of Indian trust assets, including income generated from leasing and other commercial activities on Indian trust lands, by maintaining, investing and disbursing Indian trust financial assets, and reporting on these transactions. The mission of the OST is to serve Indian communities by fulfilling Indian fiduciary trust responsibilities. This is to be accomplished through the implementation of a Comprehensive Trust Management Plan (CTM) that is designed to improve trust beneficiary services, ownership information, management of trust fund assets, and self-governance activities.
A tribe operating under self-governance may include the following programs, services, functions, and activities or portions thereof in a funding agreement:
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