Department of Health and Human Services August 7, 2012 – Federal Register Recent Federal Regulation Documents
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2012 Parenteral Drug Association/Food and Drug Administration Joint Regulatory Conference; Compliance Through Quality Systems: Implementing and Advancing a Sustainable Global Quality Culture
The Food and Drug Administration (FDA), in cosponsorship with Parenteral Drug Association (PDA), is announcing a public conference entitled ``Compliance Through Quality Systems: Implementing and Advancing a Sustainable Global Quality Culture.'' The conference will cover current issues affecting the industry as well as explore strategies and approaches for ensuring conformance with regulations to facilitate the development and continuous improvement of safe and effective medical products. The conference establishes a unique forum to discuss the foundations, emerging technologies and innovations in regulatory science, as well as the current quality and compliance areas of concerns. Meeting participants will hear from FDA and industry speakers about the requirements and best practices to consider while implementing robust quality systems in order to deliver the best quality product. Date and Time: The public conference will be held on September 10, 2012, from 7 a.m. to 6 p.m.; September 11, 2012, from 7:30 a.m. to 6:15 p.m.; and September 12, 2012, from 7:30 a.m. to 12:15 p.m. Location: The public conference will be held at the Baltimore Marriott Waterfront Hotel, 700 Aliceanna St., Baltimore, MD 21202, 410- 385-3000, Fax: 410-895-1900. Contact: Wanda Neal, Parenteral Drug Association, PDA Global Headquarters, Bethesda Towers, 4350 East West Hwy., Suite 200, Bethesda, MD 20814, 301-656-5900, ext. 111, Fax: 301-986-1093, email: info@pda.org. Accommodations: Attendees are responsible for their own accommodations. To make reservations at the Baltimore Marriott Waterfront Hotel at the reduced conference rate, contact the Baltimore Marriott Waterfront Hotel (see Location)cite the meeting code ``PDA.'' Room rates are: Single: $229, plus 15.5 percent state and local taxes and Double: $229, plus 15.5 percent state and local taxes. Reservations can be made on a space and rate availability basis. Registration: Attendees are encouraged to register at their earliest convenience. The PDA registration fees cover the cost of facilities, materials, and refreshments. Seats are limited; please submit your registration as soon as possible. Conference space will be filled in order of receipt of registration. Those accepted for the conference will receive confirmation. Registration will close after the conference is filled. Onsite registration will be available on a space available basis on each day of the public conference beginning at 7 a.m. on September 10, 2012. The cost of registration is as follows:
Announcement of Requirements and Registration for “Stop Bullying Video Challenge”
The Health Resources and Services Administration's (HRSA) Maternal and Child Health Bureau, located within the Department of Health and Human Services (HHS), announces the launch of the ``Stop Bullying Video Challenge.'' Bullying is unwanted, aggressive behavior among school aged children that involves a real or perceived power imbalance. The behavior is repeated, or has the potential to be repeated, over time. Bullying can affect everyonethose who are bullied, those who bully, and those who witness bullying. Bullying is linked to many negative outcomes including impacts on mental health, substance use, and suicide. The Federal Partners for Bullying Prevention is a Federal workgroup which is comprised of 9 departments, with 34 offices within those 9 departments, dedicated to preventing and ending bullying in schools and communities across the nation. HRSA and the Federal Partners are launching a video challenge that will encourage and motivate youth to prevent bullying. The goal of the contest is to create an impact through accepting videos that demonstrate: 1. Peer-to-peer communication, 2. Positive messaging, and 3. Promotion of the www.stopbullying.gov Web site. By using these guidelines, contestants will create relevant, youth-designed videos that stand to increase knowledge about bullying and how to prevent it.
Notice of Availability of Draft Policy Document for Comment
HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the PIN referenced above. Comments will be reviewed and analyzed, and a final PIN, along with a summary and general response to the comments, will be published as soon as possible after the deadline for receipt of comments. Background: HRSA provides grants to eligible health centers under Section 330 of the Public Health Service Act (PHS Act) to support the delivery of preventive and primary care services to medically- underserved communities and vulnerable populations. In 2011, grants helped fund approximately 1,200 health center grantees, which provided services at more than 8,500 health care delivery sites and served more than 20.2 million people. There are also approximately 100 FQHC Look- Alikes. As described in section 1861(aa)(4) and section 1905(l)(2)(B) of the Social Security Act, FQHC Look-Alikes do not receive Federal funding under Section 330 of the PHS Act. However, in order to receive the FQHC Look-Alike designation and benefits, FQHC Look-Alikes must meet the statutory, regulatory, and policy requirements for Health Centers Programs under Section 330. A key requirement of the Health Center Program is for a health center to establish a ``sliding fee discount program'' that includes a schedule of discounts for services, or ``sliding fee discount schedule,'' that ensures financial barriers to care are minimized for patients who meet certain eligibility criteria. All Section 330-funded health centers and FQHC Look-Alikes must utilize a sliding fee discount schedule that provides discounts to eligible patients based on their family size and income. The purpose of this PIN is to provide clarification on Health Center Program sliding fee discount program requirements including: (1) A schedule of fees for services; (2) a corresponding schedule of discounts for eligible patients that is adjusted on the basis of the patient's ability to pay (referred to as the sliding fee discount schedule, or SFDS for the purposes of this PIN); and (3) governing board-approved policies and procedures, including those around billing, collections, and waivers or reductions of any fees or payments required by the center for services that support the fee and discount schedules based on an individual's ability to pay. When finalized, this PIN will supersede all other previous Health Center Program guidance and policy issued on this program requirement. However, please note that this policy does not supersede patient billing requirements resulting from a health center's FQHC status under Titles XVIII and XIX of the Social Security Act (the Medicare and Medicaid programs), its implementing regulations, or policies. HRSA's Bureau of Primary Health Care is making this draft PIN available for comment. When providing comments, please be as specific as possible, and reference the section of the PIN and/or page number(s). Comments will be reviewed and analyzed, and a final PIN, along with a summary and general response to comments, will be published as soon as possible after the comment submission deadline. Comments should be submitted to OPPDSFPIN@hrsa.gov by the close of business on September 28, 2012.
Medicare Program; Inpatient Psychiatric Facilities Prospective Payment System-Update for Fiscal Year Beginning October 1, 2012 (FY 2013)
This notice updates the prospective payment rates for Medicare inpatient hospital services provided by inpatient psychiatric facilities (IPFs). These changes are applicable to IPF discharges occurring during the fiscal year (FY) beginning October 1, 2012 through September 30, 2013.
Statement of Organization, Functions, and Delegations of Authority; Office of Planning, Research and Evaluation
Statement of Organizations, Functions, and Delegations of Authority The Administration for Children and Families has realigned the Office of Planning, Research and Evaluation (OPRE). This notice establishes the Division of Family Strengthening within OPRE. It realigns research and evaluation functions among the three divisions of OPRE.
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