Department of Health and Human Services June 19, 2013 – Federal Register Recent Federal Regulation Documents
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Proposed Collection; 60-Day Comment Request; Awareness and Beliefs About Cancer Survey, National Cancer Institute (NCI)
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) Whether the proposed collection of information is necessary for the proper performance of the function of the agency, including whether the information will have practical utility; (2) 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) Ways to enhance the quality, utility, and clarity of the information to be collected; and (4) Ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology. To Submit Comments and for Further Information: To obtain a copy of the data collection plans and instruments, submit comments in writing, or request more information on the proposed project, contact: Sarah Kobrin, Division of Cancer Control and Population Sciences, 9609 Medical Center Dr., MSC 9761, Rockville, MD 20852, or call non-toll- free number 240-276-6931 or Email your request, including your address to: kobrins@mail.nih.gov. Formal requests for additional plans and instruments must be requested in writing. Comment Due Date: Comments regarding this information collection are best assured of having their full effect if received within 60 days of the date of this publication. Proposed Collection: Awareness and Beliefs about Cancer Survey, 0925-NEW, National Cancer Institute (NCI), National Institutes of Health (NIH). Need and Use of Information Collection: The objective of the study is gather data about American adults' awareness and beliefs about cancer. The ultimate goal is to determine how individuals' perceptions of cancer may influence their decisions to report signs and symptoms to health care providers, perhaps affecting the disease stage of diagnosis and the effectiveness of treatment. Data will be collected from approximately 2,000 adults aged 50 years or older across the United States for the NCI Awareness and Beliefs about Cancer survey over a one-year period. OMB approval is requested for one year. There are no costs to respondents other than their time. The total estimated annualized burden hours are 1,334.
Agency Information Collection Activities; Submission to OMB for Review and Approval; Public Comment Request
In compliance with section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Assistant Secretary for Planning and Evaluation (ASPE), Department of Health and Human Services, has submitted an Information Collection Request (ICR), described below, to the Office of Management and Budget (OMB) for review and approval. The ICR is for a new collection. Comments submitted during the first public review of this ICR will be provided to OMB. OMB will accept further comments from the public on this ICR during the review and approval period.
Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study; Public Workshop
The Food and Drug Administration (FDA), the Cardiac Safety Research Consortium, and the International Life Sciences Institute's Health and Environmental Sciences Institute (HESI) will cosponsor a public workshop entitled ``Rechanneling the Current Cardiac Risk Paradigm: Arrhythmia Risk Assessment During Drug Development Without the Thorough QT Study.'' The workshop will introduce for discussion a new nonclinical paradigm for assessing Torsade de Pointes (TdP) risk and explore the parameters for an appropriate, strong, nonclinical proarrthymia screening method as an alternative to clinical Thorough QT studies. The workshop, which will seek input from all attendees, is intended to provide a forum for stakeholders, including experts and opinion leaders from academia, industry, and regulatory agencies in the United States, the European Union, Canada, and Asian countries, to discuss what a new framework might look like, the benefits and limitations of the current guidelines, and the importance of a uniform assay schema. Date and Time: The public workshop will be held on July 23, 2013, from 8 a.m. to 6 p.m. Location: The public workshop will be held at the FDA White Oak Campus, 10903 New Hampshire Ave., Building 31 Conference Center, the Great Room (rm. 1503), Silver Spring, MD 20993. Contact Person: Devi Kozeli, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 22, rm. 4183, Silver Spring, MD 20993, 301-796-1128, email: devi.kozeli@fda.hhs.gov. SUPPLEMENTARY INFORMATION: This workshop will introduce for discussion a new nonclinical paradigm for assessing TdP risk and explore the parameters for an appropriate, strong, nonclinical proarrthymia screening method as an alternative to clinical Thorough QT studies. The workshop, which will seek input from all attendees, is intended to provide a forum for stakeholders, including experts and opinion leaders from academia, industry, and regulatory agencies in the United States, the European Union, Canada, and Asian countries, to discuss what a new framework might look like, the benefits and limitations of the current guidelines, and the importance of a uniform assay schema. A description of the planned activities for the workshop can be found at: https://www.hesiglobal.org/i4a/pages/index.cfm?pageID=3620 (FDA has verified this online address but is not responsible for subsequent changes to the Web site where it is located after this document publishes in the Federal Register.) Registration and Accommodations: Registration for non-FDA attendees should be performed online at the following address: https:// evm.auxserv.duke.edu/iebms/reg/regp1 form.aspx?oc=10&ct=DCRIHBD09&eventid=50715. (FDA has verified this online address but is not responsible for subsequent changes to the Web site where it is located after this document publishes in the Federal Register.) Registration for FDA attendees is also online, at the following address: https://duke.qualtrics.com/SE/?SID=SVbmv7T8GPm4IAPd3. The registration deadline for paying attendees is July 15, 2013. With the exception of FDA employees and a limited number of speakers or organizers, registrants must pay a registration fee covering the cost of facilities, materials, and food. The registration fees for different categories of attendee are as follows:
Linking Marketplace Heparin Product Attributes and Manufacturing Processes to Bioactivity and Immunogenicity
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of a sole source award to the University of North Carolina. The goal of the award is to identify what component(s) of the complex heparin mixtures have the propensity to cause heparin induced thrombocytopenia (HIT) to improve the safety of heparin drug products. The FDA seeks to identify the components of the heparin mixture that are associated with HIT so that actions may be taken to reduce these events and improve patient outcomes with this widely used drug.
Survey of Nanomaterial Risk Management Practices
The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces a public meeting and opportunity for comment on a proposed NIOSH survey. The primary purpose of the survey is to evaluate the use of NIOSH guidelines and risk mitigation practices for safe handling of engineered nanomaterials (ENMs) in the workplace. Information collected from the survey will be useful in future revisions of the guidelines. The public is invited to comment on the proposed survey through a public docket and/or participation in a one-day public meeting. To view the notice and related materials, visit https:// www.regulations.gov and enter CDC-2013-0010 in the search field and click ``Search.'' Public comment period: Submit either electronic or written comments by September 15, 2013. Registration to attend the meeting must be received by July 17, 2013 and will be accepted on a first come first served basis. See the SUPPLEMENTARY INFORMATION section for information on how to register for the meeting.
Cardiovascular Devices; Reclassification of Intra-Aortic Balloon and Control Systems (IABP) for Acute Coronary Syndrome, Cardiac and Non-Cardiac Surgery, or Complications of Heart Failure; Effective Date of Requirement for Premarket Approval for IABP for Other Specific Intended Uses
The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify intra-aortic balloon and control system devices when indicated for acute coronary syndrome, cardiac and non-cardiac surgery, or complications of heart failure, a preamendments class III device, into class II (special controls) based on new information. FDA is also proposing to require the filing of a premarket approval application (PMA) or a notice of completion of a product development protocol (PDP) for intra-aortic balloon and control systems when indicated for septic shock or pulsatile flow generation. 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 devices to meet the statute's approval requirements when indicated for septic shock or pulsatile flow generation. In addition, FDA is announcing the opportunity for interested persons to request that the Agency change the classification of any of the devices mentioned in this document based on new information. This action implements certain statutory requirements.
Microbiology Devices; Reclassification of Nucleic Acid-Based Systems for Mycobacterium tuberculosis
The Food and Drug Administration (FDA) is proposing to reclassify nucleic acid-based in vitro diagnostic devices for the detection of Mycobacterium tuberculosis complex in respiratory specimens from class III (premarket approval) into class II (special controls). FDA is also issuing the draft special controls guideline entitled ``Class II Special Controls Guideline: Nucleic Acid-Based In Vitro Diagnostic Devices for the Detection of Mycobacterium tuberculosis Complex in Respiratory Specimens.'' These devices are intended to be used as an aid in the diagnosis of pulmonary tuberculosis.
Food and Drug Administration Safety and Innovation Act Title VII-Drug Supply Chain; Standards for Admission of Imported Drugs, Registration of Commercial Importers and Good Importer Practices; Notification of Public Meeting; Request for Comments
The Food and Drug Administration (FDA or Agency) is announcing a public meeting regarding FDA's implementation of Title VII of the Food and Drug Administration Safety and Innovation Act (FDASIA), which provides FDA with important new authorities to help it better protect the integrity of the drug supply chain. In addition to providing a general overview of Title VII and FDA's approach to implementing these provisions, the meeting will give interested persons an opportunity to provide input that will assist FDA in the development of regulations implementing two sections of Title VII, which relate to standards for admission of imported drugs and commercial drug importers. Specifically, FDA is seeking information on the types of information that importers should be required to provide under Title VII as a condition of admission. FDA is also seeking information regarding registration requirements for commercial drug importers and good importer practices to be established under Title VII.
Patient Protection and Affordable Care Act; Program Integrity: Exchange, SHOP, Premium Stabilization Programs, and Market Standards
This proposed rule sets forth financial integrity and oversight standards with respect to Affordable Insurance Exchanges; Qualified Health Plan (QHP) issuers in Federally-facilitated Exchanges (FFEs); and States with regard to the operation of risk adjustment and reinsurance programs. It also proposes additional standards with respect to agents and brokers. These standards, which include financial integrity provisions and protections against fraud and abuse, are consistent with Title I of the Patient Protection and Affordable Care Act as amended by the Health Care and Education Reconciliation Act of 2010, referred to collectively as the Affordable Care Act.
Meeting of the Advisory Committee on Minority Health
As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (DHHS) is hereby giving notice that the Advisory Committee on Minority Health (ACMH) will hold a meeting. This meeting will be open to the public. Preregistration is required for both public attendance and comment. Any individual who wishes to attend the meetings and/or participate in the public comment session should email acmh@osophs.dhhs.gov.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public. Information about SACHRP and the full meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
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