Department of Health and Human Services July 2012 – Federal Register Recent Federal Regulation Documents

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 Clinical Center, the 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.

The NTP requests comments on Air Pollution and Children's Health, which was nominated for a possible evaluation by the Office of Health Assessment and Translation (OHAT). This nomination focuses on substances, mixtures, and exposure circumstances (collectively referred to as ``substances'') related to traffic/near road air pollution and their association with emerging children's health outcomes.

The Food and Drug Administration (FDA) has determined that TOPOTECAN INJECTION (topotecan hydrochloride) 1 milligram (mg) (base)/1 milliliter (mL), 3 mg (base)/3 mL, 4 mg (base)/4 mL, was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for topotecan hydrochloride intravenous solution 1 mg (base)/1 mL, 3 mg (base)/3 mL, 4 mg (base)/4 mL, if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is providing notice of a Statement of Cooperation (SOC) between FDA and Secretariat of Health (SS) of the United Mexican States, through the Federal Commission for Protection from Sanitary Risks (COFEPRIS). The purpose of the SOC is to safeguard public health and to ensure the safety and sanitary quality of fresh and frozen molluscan shellfish harvested from aquacultured and wild populations that are now or may be exported into the United States.

The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) Cincinnati District, in cosponsorship with Xavier University, is announcing a public conference entitled ``FDA/Xavier University Global Outsourcing Conference.'' This public conference for the pharmaceutical industry is in direct alignment with the ``FDA Strategic Priorities 2011-2015,'' and includes presentations from key FDA officials, global regulators, and industry experts. This conference drives collaboration on the topic of global outsourcing compliance by bringing pharmaceutical/biotechnology companies and contract partners to the same event to address the issues that reside on both sides of the contract. Expert presentations address the ``how to'' aspects of improving outsourced product quality through topics such as FDA International Initiatives, FDA Inspection Trends, Supply Chain Development, Quality Agreements, Supplier Qualification, and many more. The experience level of our audience has fostered engaged dialogue that has led to innovative initiatives. Dates and Times: The public conference will be held on September 24, 2012, from 8:30 a.m. to 5 p.m.; September 25, 2012, from 8:30 a.m. to 5:30 p.m.; and September 26, 2012, from 8:30 a.m. to 12:45 p.m. Location: The public conference will be held on the campus of Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745- 3073 or 513-745-3396. Contact Persons: For information regarding this notice: Steven Eastham, Food and Drug Administration, Cincinnati South Office, 36 East Seventh Street, Cincinnati, OH 45202, 513-246-4134, email: steven.eastham@fda.hhs.gov. For information regarding the conference and registration: Marla Phillips, Xavier University, 3800 Victory Pkwy., Cincinnati, OH 45207, 513-745-3073, email: phillipsm4@xavier.edu. Registration: There is a registration fee. The conference registration fees cover the cost of the presentations, training materials, receptions, breakfasts, lunches, and dinners for the 2 \1/2\ days of the conference. Early registration ends August 5, 2012. Standard registration ends September 2, 2012. Late registration occurs September 3 to September 23, 2012. There will also be onsite registration. The cost of registration is as follows:

The Indian Health Service published a document in the Federal Register on June 19, 2012, concerning Announcement Type: New. Funding Announcement Number: HHS-2012-IHS-OCPS-HIV-0001. Catalog of Federal Domestic Assistance Number: 93.933. The document contained five incorrect dates.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Service (DHHS) is hereby giving notice that the Presidential Advisory Council on HIV/AIDS (PACHA) will hold a meeting. The meeting will be open to the public.

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: ``American Recovery and Reinvestment Act ``Developing a Registry of Registries''.'' 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 Federal Register on February 23rd, 2012 and allowed 60 days for public comment. Several comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

The Office of the National Coordinator for Health Information Technology (ONC) announces the launch of the What's In Your Health Record Video Challenge. This challenge is an open call for the public to create and submit short, compelling videos sharing how getting access to your health record and checking the information can help make sure you or your loved one get the best care. Having access to your health record is fundamental to your ability to participate in your health care. Patients and their families have a legal right under the HIPAA Privacy Rule to request to see and get a copy of their health record (``right to access'') from most doctors, hospitals and other health care providers, such as pharmacies and nursing homes, as well as from their health plans. Patients can use that information to better understand their health, to coordinate their care with other health care providers or to help identify possible errors or omissions in their medical records. Patients can get access to their health information through a patient portal, or a personal health record (PHR) or by email. This is the third in a series of Health IT video contests that will occur throughout 2012. The video contests are one way to crowd source stories from the public about how they are benefiting from health information technology (health IT). This is one way ONC is working to motivate and inspire individuals to play a more active role in their health. Each video contest will be a call to action for members of the public to create a short video clip [2 minutes or less] on a particular topic, and will award cash prizes to winners in several categories.

The Food and Drug Administration (FDA) is proposing to establish a unique device identification system to implement the requirement added to the Federal Food, Drug, and Cosmetic Act (FD&C Act) by section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA), Section 226 of FDAAA amended the FD&C Act to add new section 519(f), which directs FDA to promulgate regulations establishing a unique device identification system for medical devices. The system established by this rule would require the label of medical devices and device packages to include a unique device identifier (UDI), except where the rule provides for alternative placement of the UDI or provides an exception for a particular device or type of device such as devices sold over-the-counter and low risk devices. Each UDI would have to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. The UDI would also be required to be directly marked on the device itself for certain categories of devices for which the labeling requirement may not be sufficient, for example, those that remain in use for an extended period of time and devices that are likely to become separated from their labeling. The rule would require the submission of information concerning each device to a database that FDA intends to make public, to ensure that the UDI can be used to adequately identify the device through its distribution and use.