Department of Health and Human Services July 27, 2011 – Federal Register Recent Federal Regulation Documents

As part of a Federal Government-wide effort to streamline the process to seek feedback from the public on service delivery, National Cancer Center (NCI) has submitted a Generic Information Collection Request (Generic ICR): ``Generic Clearance for the Collection of Qualitative Feedback on Agency Service Delivery'' to OMB for approval under the Paperwork Reduction Act (PRA) (44 U.S.C. 3501 et seq.).

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.

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 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).

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.

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: ``Evaluation of ARRA Comparative Effectiveness Research Dissemination Contractor Efforts.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection.