March 21, 2008 – Federal Register Recent Federal Regulation Documents

The Federal Communications Commission, as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection, as required by the Paperwork Reduction Act (PRA) of 1995, Public Law No. 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. Pursuant to the PRA, no person shall be subject to any penalty for failing to comply with a collection of information that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

In accordance with Section 3507(j) of the Paperwork Reduction Act of 1995, the National Institutes of Health hereby publishes notification of an Emergency Clearance for the expansion of the information related to the ``Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank.'' The expanded program will include information on certain clinical trials of drugs, biologics, and devices, whether or not they relate to serious and life-threatening diseases. The information collection is essential to the mission of the FDA and National Institutes of Health [42 U.S.C. 282(j)(2)(A)(ii)] and is critical to meeting their roles in the Clinical Trial Registry that was expanded by Public Law 110-85, which was enacted on September 27, 2007. NIH cannot reasonably comply with the normal clearance procedures for information collection, because the use of normal procedures will delay the collection and hinder the agency in accomplishing its mission and meeting new statutory requirements, to the detriment of the public good. Compelling reason exists for the collection of required information for successful planning and implementation of the expansion of the Clinical Trial Registry, as described in Public Law 110-85. This information collection is essential to the effective stewardship of Federal Funds. After consultation with other agencies and NIH components, NIH has determined that the information is not currently available in any single, reliable, accessible source. Proposed Collection: Title: Information Program on Clinical Trials for Serious and Life-Threatening Diseases: Maintaining a Databank; Type of Information Collection Request: New; Form Number: NA; Need and Use of Information Collection: In compliance with provisions of Title VIII of Public Law 110-85 (Food and Drug Administration Amendments Act of 2007) the National Institutes of Health is modifying the clinical trial registry established under previous law [ClinicalTrials.gov, established in response to FDAMA, Section 113]. The registry collects specified information on certain clinical trials identified in the law, with the objective of enhancing patient enrollment and providing a mechanism for tracking subsequent progress of clinical trials, to the benefit of public health. The registry is widely used by patients, physicians, and medical researchers, in particular those involved in clinical research studies. Public Law 110-85 expands the scope of clinical trials that must be registered in ClinicalTrials.gov to include certain defined clinical trials of drugs, biologics, and devices subject to FDA regulation, regardless of whether they are related to serious or life-threatening diseases. It also increases the clinical trial information (i.e., number of data elements) that must be submitted as part of each registration. Frequency of Response: Responsible parties for applicable clinical trials must submit the required information shortly after the initiation of a trial [by the later of 21 days after the first patient is enrolled or December 26, 2007]. Updates to registration records are thereafter required at least once a year, unless there are no changes to report. Changes in recruitment status and completion of a trial must be reported not later than 30 days after such events. Records for trials that were ongoing (as defined in the Law) as of December 26, 2007 are also required to be updated to comply with the new registration data elements, even if they were previously registered. Description of Respondents: Respondents are referred to in the law as ``responsible parties.'' The statute defines the responsible party as: (1) The sponsor of the clinical trial (as defined in 21 CFR 50.3) or (2) the principal investigator of such clinical trial if so designated by a sponsor, grantee, contractor, or awardee, provided that ``the principal investigator is responsible for conducting the trial, has access to and control over the data from the clinical trial, has the right to publish the results of the trial, and has the ability to meet all of the requirements'' for submitting information under the law. Estimate of Burden: Under the clearance to date (OMB No. 0910- 0459), the FDA total hours burden was 200,839. The current annual reporting burden is shown in Table 1. It is estimated that approximately 3,500 applicable clinical trials of drugs and biologics and 445 applicable trials of devices will be registered annually in accordance with Public Law 110-85, Section 801. This estimate is based on FDA reports that in 2005 some 5,332 new clinical trial protocols were submitted to its Center for Drug Evaluation and Research and 474 new protocols were submitted to the Center for Biologics Evaluation and Research. FDA projects that rates of submission will remain at or near this level in the near future. An estimated 50% of the drug and biological protocols received in 2005, or approximately 2,900 protocols, were for trials involving assessments of effectiveness, which would be subject to the provisions of Title VIII of Public Law 110-85. This figure was raised to 3,500 drug and biological trials per year to account for IND-exempt trials that are required to register in the expanded registration data bank, but for which a protocol might not be sent to FDA. The estimated 445 new applicable device clinical trials per year includes trials related to pre-market applications (approximately 50 applications to FDA containing 75 clinical trial protocols in 2005), 510(k) submissions (approximately 360 submissions to FDA containing clinical trial protocols in 2005), and humanitarian device exemptions (9 in 2005). The estimates of drug, biologic, and device trials computed using this approach are consistent with the numbers of relevant trials that were registered with the ClinicalTrials.gov registry in calendar year 2007. The hour burden accounts for time required to register trials and provide necessary updating over the course of the study. Based on previous experience, it is estimated that each new registration record will be updated an average of 8 times during the course of the study (e.g., to reflect protocol changes, additions of investigational sites, updates of recruitment status, trial completion). The time to complete an initial (new) registration (for trials of drugs, biologics, or devices) is estimated to be 7 hours (including time to extract, reformat and submit information which has already been produced for other purposes), an increase of 50% above the 4.6 hours that was estimated by FDA for the smaller set of information collected under previous law. The time required for subsequent updates of this information is expected to be significantly less than for the original registration (as less information must be provided), and is estimated at 2 hours per update. Applying these figures to the anticipated numbers of trials produces a burden estimate for mandatory, new trial registrations of 90,735 hours.

The Federal Communications Commission (FCC), as part of its continuing effort to reduce paperwork burdens, invites the general public and other Federal agencies to take this opportunity to comment on the following information collection(s), as required by the Paperwork Reduction Act (PRA) of 1995, Public Law 104-13. An agency may not conduct or sponsor a collection of information unless it displays a currently valid control number. No person shall be subject to any penalty for failing to comply with a collection of information subject to the Paperwork Reduction Act (PRA) that does not display a valid control number. Comments are requested concerning (a) whether the proposed collection of information is necessary for the proper performance of the functions of the Commission, including whether the information shall have practical utility; (b) the accuracy of the Commission's burden estimate; (c) ways to enhance the quality, utility, and clarity of the information collected; and (d) ways to minimize the burden of the collection of information on the respondents, including the use of automated collection techniques or other forms of information technology.

EPA expressed environmental concerns about the long-term impacts to marine habitats and migratory species from dredge/fill actions, and requested a more thorough cumulative impacts analysis and suggested the Corps consider developing a broader shoreline management strategy. Rating EC2.

The proposed information collection requirement described below will be submitted to the Office of Management and Budget (OMB) for review, as required by the Paperwork Reduction Act. The Department is soliciting public comments on the subject proposal.

Congress amended the Magnuson-Stevens Fishery Conservation and Management Act (Magnuson-Stevens Act) to require the Secretary of Commerce (Secretary) to approve the Bering Sea/Aleutian Islands (BSAI) Crab Rationalization Program (Program). The Program allocates BSAI crab resources among harvesters, processors, and coastal communities. Amendment 26 would modify the Fishery Management Plan for Bering Sea/ Aleutian Islands (BSAI) King and Tanner crabs (FMP) and the Program to Amendment 26 to the FMP would exempt quota share issued to crew members, and the annual harvest privileges derived from that quota share, from requirements for: delivery to specific processors; delivery within specific geographic regions; and participation in an arbitration system to resolve price disputes. This action is intended to promote the goals and objectives of the Magnuson-Stevens Act, the FMP, and other applicable laws.

The OCC, Board, FDIC, OTS, FCA, and NCUA (collectively, the Agencies) are soliciting comment on proposed revisions to the Interagency Questions and Answers Regarding Flood Insurance (Interagency Questions and Answers). To help financial institutions meet their responsibilities under Federal flood insurance legislation and to increase public understanding of their flood insurance regulations, the staffs of the Agencies have prepared proposed new and revised guidance addressing the most frequently asked questions and answers about flood insurance. The proposed revised Interagency Questions and Answers contain staff guidance for agency personnel, financial institutions, and the public.

NMFS proposes management measures for the 2008 summer flounder, scup, and black sea bass recreational fisheries. The implementing regulations for these fisheries require NMFS to publish recreational measures for the fishing year and to provide an opportunity for public comment. The intent of these measures is to prevent overfishing of the summer flounder, scup, and black sea bass resources.

This notice is a call for nominees for the U.S. Delegation to the June 2008 International Whaling Commission (IWC) annual meeting. The non-federal representative(s) selected as a result of this nomination process is(are) responsible for providing input and recommendations to the U.S. IWC Commissioner representing the positions of non-governmental organizations. Generally, only one non-governmental position is selected for the U.S. Delegation.

The South Atlantic Fishery Management Council will hold a meeting of its Allocation Committee in North Charleston, SC.

The Coast Guard proposes to establish special local regulations for the ``William I. Koch International Sea Scout Cup'', a sailboat regatta to be held on the waters of the Severn River, Annapolis, Maryland. These special local regulations are necessary to provide for the safety of life on navigable waters during the event. This action is intended to restrict vessel traffic in portions of the Severn River adjacent to the U.S. Naval Academy, Annapolis, Maryland during the sailboat regatta.

The Mid-Atlantic Fishery Management Council (Council), its Science and Statistical Committee (SSC), its Ad Hoc Excessive Shares Committee, the Mid-Atlantic section of the Joint Monkfish Committee, its Protected Resources Committee, its Research Set-Aside (RSA) Committee, its Executive Committee, its Surfclam/Ocean Quahog Committee, its Bycatch Committee, and its Demersal Committee, will hold public meetings.

In accordance with the Paperwork Reduction Act of 1995, the Bureau of Land Management (BLM) is requesting the Office of Management and Budget (OMB) to extend an existing approval to collect information from entities desiring a right-of-way across public lands under 43 CFR parts 2800 and 2880. The BLM and several other agencies use Form 299, Application for Transportation and Utility System and Facility, to determine whether applicants qualify to hold right-of-way grants across public lands, and for several other purposes.

The Committee for Purchase From People Who Are Blind or Severely Disabled (The Committee) is submitting the collection of information listed below to OMB for approval under the provisions of the Paperwork Reduction Act. This notice solicits comments on that collection of information.

The Committee is proposing to add to the Procurement List a product to be furnished by nonprofit agencies employing persons who are blind or have other severe disabilities, and to delete a product and services previously furnished by such agencies. Comments Must be Received on or Before: April 20, 2008.

This notice announces the surplus and purchased commodities that the Department expects to make available for donation to States for use in providing nutrition assistance to the needy under the Emergency Food Assistance Program (TEFAP) in Fiscal Year (FY) 2008. The commodities made available under this notice must, at the discretion of the State, be distributed to eligible recipient agencies for use in preparing meals and/or for distribution to households for home consumption.

The EPA's Science Advisory Board (SAB) Staff Office is announcing a public teleconference of the SAB Environmental Economics Advisory Committee (EEAC) to receive a briefing from the EPA National Center for Environmental Economics (NCEE) regarding its upcoming advisory requests. The EEAC will also discuss plans for possible self- initiated projects.

This notice announces that the Agricultural Marketing Service (AMS) plans to review the Regulations (Other than Rules of Practice) under the Perishable Agricultural Commodities Act, 1930, as amended, under the criteria contained in section 610 of the Regulatory Flexibility Act (RFA).

The Utah Reclamation Mitigation and Conservation Commission (Mitigation Commission), Central Utah Water Conservancy District (District) and U.S. Department of the Interior (Department), jointly prepared an Environmental Assessment (EA) to determine the effects of reconstructing the Fort Field Diversion on the Provo River in Utah County, to provide unimpaired fish passage during low flow conditions and to meet diversion requirements for canal companies and legal water users. The Proposed Action selected from the EA for implementation entails the Mitigation Commission, District and Department cooperating to reconstruct the Fort Field Diversion structure, consisting of a cobble bar, a concrete sluiceway, with gates, tree removal and replacement or lining of a section of pipeline. The Fort Field Diversion often functions as a dry dam: it diverts the entire stream flow of Provo River, with the exception of small quantities of water that leak through the diversion structure. It is also the lowest diversion on the Provo River and the first diversion encountered by June sucker as they ascend the Provo River to spawn. The June sucker is an endangered fish species found only in Utah Lake, which swims from Utah Lake up into the Provo River to spawn. The Fort Field Diversion restricts June sucker spawning to only the lowest 3.8 miles of Provo River, and compromises the quality of spawning habitat in that lower reach; the upper 1.1 miles of the 4.9 mile reach designated as critical habitat for June sucker, is often inaccessible during May and June, when June sucker spawn. The decision to select the Proposed Action from the EA will allow reconstruction of the Fort Field diversion structure resulting in fish passage and access to the additional 1.1 miles of June sucker's critical habitat. It will also allow accurate and real-time bypass and measurement of instream flows, maintaining the ability to meet diversion requirements for canal companies and legal water users who divert water at the Fort Field Diversion structure. Based on information contained in the EA, a Finding of No Significant Impact (FONSI) was made, thus the Proposed Action does not require preparation of an Environmental Impact Statement (EIS) (it will not have a significant effect on the human environment; negative environmental impacts that could occur are negligible and can be generally eliminated with mitigation; there are no unmitigated adverse impacts on public health or safety, threatened or endangered species, sites or districts listed in or eligible for listing in the National Register of Historic Places, or other unique characteristics of the region; no highly uncertain or controversial impacts, unique or unknown risks, cumulative effects, or elements of precedence were identified that have not been mitigated; and, implementation of the action will not violate any federal, state, or local environmental protection law.)