Department of Health and Human Services August 2012 – Federal Register Recent Federal Regulation Documents
Results 201 - 250 of 285
Request for Notification From Industry Organizations Interested in Participating in Selection Process for Nonvoting Industry Representative on the Pediatric Advisory Committee and Request for Nominations for Nonvoting Industry Representatives on the Pediatric Advisory Committee
The Food and Drug Administration (FDA) is requesting that any industry organizations interested in participating in the selection of a nonvoting industry representative to serve on the Pediatric Advisory Committee for the Office of the Commissioner (OC) notify FDA in writing. FDA is also requesting nominations for a nonvoting industry representative(s) to serve on the Pediatric Advisory Committee. A nominee may either be self-nominated or nominated by an organization to serve as a nonvoting industry representative. Nominations will be accepted for current vacancies effective with this notice.
Administrative Simplification: Adoption of Operating Rules for Health Care Electronic Funds Transfers (EFT) and Remittance Advice Transactions
This interim final rule with comment period implements parts of section 1104 of the Affordable Care Act which requires the adoption of operating rules for the health care electronic funds transfers (EFT) and remittance advice transaction.
Meeting of the National Advisory Council on Healthcare Research and Quality Subcommittee on Quality Measures for Children's Healthcare
In accordance with section 10(a) of the Federal Advisory Committee Act, 5 U.S.C. App. 2, this notice announces a meeting of the National Advisory Council on Healthcare Research and Quality Subcommittee on Quality Measures for Children's Healthcare.
New Animal Drugs; Cephalexin; Fentanyl; Milbemycin Oxime and Praziquantel
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications (NADAs) and abbreviated new animal drug applications (ANADAs) during June 2012. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.
Agency Information Collection Activities; Proposed Collection; Comment Request; Semi-Annual and Final Reporting Requirements for Discretionary Grant Programs
The Administration for Community Living (ACL) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection requirements relating to the continuation of an existing collection for Performance Progress Reports previously approved for discretionary grants funded by the U.S. Administration on Aging (AoA), which is now a part of ACL.
Agency Information Collection Activities; Announcement of Office of Management and Budget Approval; MedWatch: The Food and Drug Administration Medical Products Reporting Program
The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``MedWatch: The Food and Drug Administration Medical Products Reporting Program'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.
Request for Nominations of Specific Drug/Biologic Product(s) That Could Be Brought Before the Food and Drug Administration's Pediatric Subcommittee of the Oncologic Drugs Advisory Committee
The Food and Drug Administration's (FDA) Office of Hematology and Oncology Products invites the public to suggest one or more specific drug or biologic products that could be brought before the December 4, 2012, Pediatric Subcommittee of the Oncologic Drugs Advisory Committee (ODAC). The number of drugs studied for use in pediatric patients is growing, and we see a reduction in off-label use. However, we would like to improve current and future pediatric product development by focusing on products whose development would benefit the most from the attention of an advisory committee. The company developing a product that is brought before the committee will be given the unique opportunity to present proposed pediatric studies in the United States, share their plans for global pediatric development, and hear discussions by the Pediatric Subcommittee on possible directions for their current or future pediatric oncology product development.
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.
New Animal Drugs; Change of Sponsor; Change of Sponsor Address; Azaperone; Miconazole, Polymyxin B, and Prednisolone Suspension
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect a change of sponsor for two new animal drug applications (NADAs) from Janssen Pharmaceutica NV, to Elanco Animal Health, a Division of Eli Lilly & Co. FDA is also amending the animal drug regulations to reflect a change of sponsor's address for Veterinary Service, Inc.
Documents to Support Submission of an Electronic Common Technical Document; Availability
The Food and Drug Administration (FDA) is announcing the availability of the following final versions of documents that support making regulatory submissions in electronic format using the electronic Common Technical Document (eCTD) specifications: ``The eCTD Backbone Files Specification for Module 1, version 2.0'' (which includes the U.S. regional document type definition (DTD), version 3.0) and ``Comprehensive Table of Contents Headings and Hierarchy, version 2.0.'' Supporting technical files are also being made available on the Agency Web site. These documents represent FDA's major updates to Module 1 of the eCTD, which contains regional information. FDA is not prepared at present to accept submissions utilizing this new version because eCTD software vendors need time to update their software to accommodate this information and because its use will require software upgrades within the Agency. FDA estimates it will be able to receive submissions utilizing Module 1 Specifications 2.0 by September 2013, but this is not a firm date and we will give 30 days advance notice to industry.
Clinical Studies of Safety and Effectiveness of Orphan Products Research Project Grant (R01)
The Food and Drug Administration (FDA) is announcing the availability of grant funds for the support of FDA's Office of Orphan Products Development (OPD) grant program. The goal of FDA's OPD grant program is to support the clinical development of products for use in rare diseases or conditions where no current therapy exists or where the proposed product will be superior to the existing therapy. FDA provides grants for clinical studies on safety and/or effectiveness that will either result in, or substantially contribute to, market approval of these products. Applicants must include in the application's Background and Significance section documentation to support the assertion that the product to be studied meets the statutory criteria to qualify for the grant and an explanation of how the proposed study will either help support product approval or provide essential data needed for product development.
Decision To Evaluate a Petition To Designate a Class of Employees From the Baker Brothers Site in Toledo, Ohio, To Be Included in the Special Exposure Cohort
NIOSH gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees from the Bakers Brothers site in Toledo, Ohio, to be included in the Special Exposure Cohort under the Energy Employees Occupational Illness Compensation Program Act of 2000. The initial proposed definition for the class being evaluated, subject to revision as warranted by the evaluation, is as follows: Facility: Baker Brothers. Location: Toledo, Ohio. Job Titles and/or Job Duties: All employees who worked in any area. Period of Employment: June 1, 1943 to December 31, 1996.
Final Effect of Designation of a Class of Employees for Addition to the Special Exposure Cohort
HHS gives notice concerning the final effect of the HHS decision to designate a class of employees from the Feed Materials Production Center in Fernald, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On June 27, 2012, as provided for under 42 U.S.C. 7384q(b), the Secretary of HHS designated the following class of employees as an addition to the SEC:
Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT); Public Workshop
The Food and Drug Administration's (FDA) Center for Drug Evaluation and Research is announcing a 4-day public workshop entitled ``Gastroenterology Regulatory Endpoints and the Advancement of Therapeutics (GREAT).'' The purpose of this workshop is to provide a forum to consider issues related to endpoints that can support drug development in the following disease areas: Eosinophilic esophagitis, pediatric and adult inflammatory bowel disease, and parenteral nutrition-associated liver disease.
Medicare Program; Prior Authorization for Power Mobility Device (PMD) Demonstration
This notice announces a 3-year Medicare Prior Authorization for Power Mobility Device (PMD) Demonstration for certain PMD codes in seven states where there have been high incidences of fraudulent claims and improper payments
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