July 27, 2011 – Federal Register Recent Federal Regulation Documents

The U.S. Office of Personnel Management (OPM) is announcing the withdrawal of an information collection notice that published on Friday, July 22, 2011. The notice offered the general public and other Federal agencies the opportunity to comment on a revised information collection request (ICR) 3206-0219, USAJOBS.

The National Institute of Health (NIH), as part of its continuing effort to reduce paperwork and respondent burden, invites the general public and other Federal agencies to take this opportunity to comment on proposed and/or continuing information collections, as required by the Paperwork Reduction Act of 1995, Section 3506. Proposed Collection: Title: The Genetic Testing Registry; Type of Information Collection Request: New collection; Need and Use of Information Collection: Laboratory tests for more than 2,000 genetic conditions are available; however, there is no centralized public resource that provides information about the availability and scientific basis of these tests. Recognizing the importance of making this information easily accessible to health care providers, patients, consumers, and others, NIH is developing a voluntary registry of genetic tests. The Genetic Testing Registry (GTR) will provide a centralized, online location for test developers, manufacturers, and researchers to submit detailed information about genetic tests. The overarching goal of the GTR is to advance the public health and research in the genetic basis of health and disease. As such, the Registry will have several key functions, including (1) encouraging providers of genetic tests to enhance transparency by publicly sharing information about the availability and utility of their tests; (2) providing an information resource for the public, including health care providers, patients, and researchers, to locate laboratories that offer particular tests; and (3) facilitating genetic and genomic data-sharing for research and new scientific discoveries. Frequency of Response: The information will be submitted voluntarily on a non-repeating, continual basis, which means submitters will register a test once and can add new tests on a continual basis. Submitters will be requested to update their test information at least once every 12 months. Description of Respondents: Submitters to the GTR are expected to include clinical laboratories, test manufacturers, researchers, and entities that report and interpret tests performed elsewhere. The GTR is not limited to U.S. respondents; it will also include submissions from outside the United States. Information will be collected and managed using an online submission system. Estimate of Burden: Data from the GeneTests Laboratory Directory, which is currently the most comprehensive listing available for laboratories that provide genetic tests, was used to estimate both the number of participating laboratories as well as the number of genetic tests which might be submitted to the GTR. Analysis of the database showed that there are 593 laboratories and approximately 7,800 genetic tests listed in GeneTests. Approximately half of the laboratories in GeneTests (291, or 49 percent) list 12 or fewer tests, while approximately 40 percent (239) list between 13 and 100 tests, and the remaining 10 percent (63) list 100 or more tests. To account for genetic test providers that are not listed in GeneTests, the number of laboratories was multiplied by 1.2, bringing the estimated number of potential participants in GTR to 770. A multiplier of 1.2 was used to account for tests that are not in GeneTests but that might be submitted to the GTR, including test categories not covered by GeneTests (e.g., pharmacogenomic tests), as well as tests that meet the criteria for GeneTests but that have not been submitted to the database. Applying the 1.2 multiplier yields an estimated 9,360 tests for which information could be submitted to GTR. Although participation in the GTR is voluntary, in order to participate, the submitter must provide information for a certain subset of data fields, identified as the ``minimal fields.'' GTR includes 31 minimal fields and 85 optional fields. Separate estimates of hour burden are provided for minimal, optional, and all fields (Table 1). The calculations include the time and effort necessary for the test provider to gather information for the data elements and to enter the information into the GTR online submission form. Based on simulated trials of entering test information into GTR, it will take submitters an average of 0.5 hours per test to provide information for the minimal fields. With an average of 12.2 tests per respondent, the estimated annual hour burden for a respondent to complete the minimal fields is 6.1 hours. An estimated additional 2.5 hours per test was projected for the optional fields for an annual burden of 30.5 hours per respondent. The annual hour burden for a respondent to complete all fields is 36.6 hours. The calculations for annual burden reflect the average time for submitters who are familiar with their tests and know where to find information about the tests. For those submitters who are not familiar with information about their tests, it may take longer than the estimated 2.5 hours to provide the optional fields information. However, submitters should become more efficient in data entry as they gain experience with GTR, and significant time savings can be achieved by laboratories with large numbers of tests who use the bulk upload feature. In addition, those test providers whose tests are already listed in GeneTests will have the data from GeneTests automatically transferred to GTR, saving them data entry time.

The inventions listed below are owned by an agency of the U.S. Government and are available for licensing in the U.S. in accordance with 35 U.S.C. 207 to achieve expeditious commercialization of results of federally-funded research and development. Foreign patent applications are filed on selected inventions to extend market coverage for companies and may also be available for licensing.

Under the Paperwork Reduction Act of 1995, Public Law 104-13 (44 U.S.C. 3501 et seq.), and as part of its continuing effort to reduce paperwork and respondent burden, the National Science Foundation (NSF) is inviting the general public and other Federal agencies to comment on this proposed continuing information collection. The full submission may be found at: https://www.reginfo.gov/public/do/PRAMain. This is the second notice for public comment; the first was published in the Federal Register at 76 FR 28244 and no comments were received. NSF is forwarding the proposed submission to the Office of Management and Budget (OMB) for clearance simultaneously with the publication of this second notice.

In accordance with the requirements of the Privacy Act of 1974, 5 U.S.C. 552a, the Department of the Treasury gives notice of an amendment to update its Privacy Act regulations, and to add an exemption from certain provisions of the Privacy Act for a system of records related to the Office of Financial Stability (OFS).

The Food and Drug Administration (FDA) is proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for the class III preamendments device implantable pacemaker pulse generator. The Agency is also summarizing its proposed findings regarding the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to meet the statute's approval requirements and the benefits to the public from the use of the device. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of the aforementioned device based on new information. This action implements certain statutory requirements.

The U.S. Nuclear Regulatory Commission (NRC) is proposing to amend its Title 10 of the Code of Federal Regulations (10 CFR) Part 40 regulations by adding additional requirements for source material licensees who possess significant quantities of uranium hexafluoride (UF6). The proposed rule and proposed guidance document were published in the Federal Register on May 17, 2011 (76 FR 28336), for public comment and an administrative correction to 76 FR 28336 was published in the Federal Register on June 1, 2011 (76 FR 31507). The Nuclear Energy Institute (NEI), in a letter dated June 21, 2011, requested the NRC to hold a public meeting on the proposed rule and draft guidance document and to extend the public comment period. Based on NEI's request, the NRC will conduct a public meeting on August 17, 2011, to seek public input on the proposed rule and its associated draft guidance document. In addition, the NRC is extending the public comment period for the proposed rule and associated draft guidance document from 75 days to 115 days to allow the public ample opportunity to submit written comments.

The National Urban and Community Forestry Advisory Council, (NUCFAC) will be filling three positions that will expire at the end of December 2011. Interested applicants may download a copy of the application and position descriptions from the U.S. Forest Service's Urban and Community Forestry Web site: https://www.fs.fed.us/ucf.

In accordance with the Paperwork Reduction Act of 1995, the Forest Service is seeking comments from all interested individuals and organizations on the extension of a currently approved information collection, Locatable Minerals-36 CFR part 228, subpart A.

The Secretary of Homeland Security determined on September 23, 2008 that there is a significant potential for a domestic emergency involving a heightened risk of attack with a specified biological, chemical, radiological, or nuclear agent or agentsin this case, Bacillus anthracis. On the basis of this determination, the Secretary of Health and Human Services is renewing the October 1, 2008 declaration by former Secretary Michael O. Leavitt of an emergency justifying the authorization of emergency use of doxycycline hyclate tablets accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs under 21 U.S.C. 360bbb-3(a) and amending the declaration to include all oral formulations of doxycyline accompanied by emergency use information subject to the terms of any authorization issued by the Commissioner of Food and Drugs under 21 U.S.C. 360bbb-3(a). This notice is being issued in accordance with section 564(b)(4) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 360bbb-3(b)(4).

This document provides required notice of substantive rules issued by the Coast Guard and temporarily effective between December 2008 and July 2010, that expired before they could be published in the Federal Register. This notice lists temporary safety zones, security zones, special local regulations, drawbridge operation regulations and regulated navigation areas, all of limited duration and for which timely publication in the Federal Register was not possible.

As part of its statutory authority and responsibility to analyze sentencing issues, including operation of the Federal sentencing guidelines, and in accordance with Rule 5.2 of its Rules of Practice and Procedure, the United States Sentencing Commission is seeking comment on possible priority policy issues for the amendment cycle ending May 1, 2012.

On July 27, 2009, NHTSA published a final rule that amended the Federal motor vehicle safety standard for air brake systems by requiring substantial improvements in stopping distance performance on new truck tractors. In response, the agency received eight petitions for reconsideration. The agency has already responded to most of the issues raised in the petitions. This document responds to the one outstanding issue raised in the petitions, stopping distance performance requirements at lower initial speeds. Based on testing results and our concern that the current requirements might not be practicable, NHTSA is slightly relaxing the stopping distance requirement for typical loaded tractors tested from an initial speed of 20 mph by increasing the distance from 30 feet to 32 feet and for unloaded tractors tested from an initial speed of 20 mph by increasing the distance from 28 feet to 30 feet. We believe no other changes are necessary.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``510(k) Device Modifications: Deciding When To Submit a 510(k) for a Change to an Existing Device.'' The recommendations in this guidance document are intended to describe when a new 510(k) should be submitted for a change or modification to a legally marketed device. This draft guidance is not final nor is it in effect at this time.