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

The Food and Drug Administration (FDA), Center for Tobacco Products (CTP) is announcing an invitation for participation in its Tobacco Product Manufacturing Facility Visits. This program is intended to give FDA staff an opportunity to visit facilities involved in the manufacturing of tobacco products, including any related laboratory testing, and observe the manufacturing operations of the tobacco industry. The purpose of this notice is to invite parties interested in participating in Tobacco Product Manufacturing Facility Visits to submit requests to CTP.

In accordance with the requirements of the Privacy Act of 1974, HHS gives notice of a proposed alteration to two existing systems of records covering payroll records: 09-40-0006 entitled ``Public Health Service (PHS) Commissioned Corps Payroll Records, HHS/PSC/HRS,'' and 09-40-0010 entitled ``Pay, Leave and Attendance Records, HHS/PSC/ HRS.'' The systems are being amended to revise an existing routine use covering disclosures to contractors and to add a new routine use pertaining to system security. The routine use changes are described in more detail in the Supplementary Information section below.

The Office of the National Coordinator for Health Information Technology (ONC) announces the launch of the Managing Meds Video Challenge. This challenge is an open call for the public to create short, inspiring videos sharing how you use technology to manage your medications effectively or how health care providers or caregivers support individuals to take their medications as directed, improving patient health and safety. This is the fourth in a series of Health IT video contests that will occur throughout 2012. The goal of this video contest series is to generate content that will be used to motivate and inspire others to leverage technology to better manage their health and be more engaged partners in their health and health care. Each challenge will be a call to action for members of the public to create a short video clip [2 minutes or less] on a particular theme, and will award cash prizes to winners in several categories.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Refuse to Accept Policy for 510(k)s.'' The purpose of this document is to explain the procedures and criteria FDA intends to use in determining whether a premarket notification (510(k)) submission is administratively complete, which determines whether it should be accepted for substantive review. This guidance is applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). This draft guidance is not final nor is it in effect at this time.

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.

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.

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.

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.

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.

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.

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.

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

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``General Administrative Procedures: Citizen Petitions; Petition for Reconsideration or Stay of Action; Advisory Opinions'' has been approved by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995.

The Food and Drug Administration (FDA) is amending its regulations to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C Act by requiring domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments are required to submit such information. In addition, this final rule would facilitate FDA's collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The final rule will update certain provisions in the regulations to improve the quality of registration and listing information available to FDA. FDA relies on having complete and accurate registration and listing information in order to accomplish a number of important public health objectives.

The Food and Drug Administration (FDA) 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 reporting requirements contained in FDA's regulations on postmarketing reporting of information pertaining to drug shortages.

The Food and Drug Administration (FDA) is announcing the rates for prescription drug user fees for fiscal year (FY) 2013. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Prescription Drug User Fee Amendments of 2012 (Title 1 of the Food and Drug Administration Safety and Innovation Act (FDASIA), Public Law 112- 144, which was signed by the President on July 9, 2012) (PDUFA V)), authorizes FDA to collect user fees for certain applications for approval of drug and biological products, on establishments where the products are made, and on such products. Base revenue amounts to be generated from PDUFA fees were established by PDUFA V, with provisions for certain adjustments. Fee revenue amounts for applications, establishments, and products are to be established each year by FDA so that one-third of the PDUFA fee revenues FDA collects each year will be generated from each of these categories. This document establishes fee rates for FY 2013 for application fees for an application requiring clinical data ($1,958,800), for an application not requiring clinical data or a supplement requiring clinical data ($979,400), for establishment fees ($526,500), and for product fees ($98,380). These fees are effective on October 1, 2012, and will remain in effect through September 30, 2013. For applications and supplements that are submitted on or after October 1, 2012, the new fee schedule must be used. Invoices for establishment and product fees for FY 2013 will be issued in August 2012 using the new fee schedule.

The Food and Drug Administration (FDA) is announcing the rates and payment procedures for fiscal year (FY) 2013 animal drug user fees. The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended by the Animal Drug User Fee Act of 2003 (ADUFA) and the Animal Drug User Fee Amendments of 2008 (ADUFA II), authorizes FDA to collect user fees for certain animal drug applications and supplements, for certain animal drug products, for certain establishments where such products are made, and for certain sponsors of such animal drug applications and/or investigational animal drug submissions. This notice establishes the fee rates for FY 2013.

The Department of Health and Human Services (HHS) notifies Federal agencies of the Laboratories and Instrumented Initial Testing Facilities (IITF) currently certified to meet the standards of the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Mandatory Guidelines). The Mandatory Guidelines were first published in the Federal Register on April 11, 1988 (53 FR 11970), and subsequently revised in the Federal Register on June 9, 1994 (59 FR 29908); September 30, 1997 (62 FR 51118); April 13, 2004 (69 FR 19644); November 25, 2008 (73 FR 71858); December 10, 2008 (73 FR 75122); and on April 30, 2010 (75 FR 22809). A notice listing all currently certified Laboratories and Instrumented Initial Testing Facilities (IITF) is published in the Federal Register during the first week of each month. If any Laboratory/IITF's certification is suspended or revoked, the Laboratory/IITF will be omitted from subsequent lists until such time as it is restored to full certification under the Mandatory Guidelines. If any Laboratory/IITF has withdrawn from the HHS National Laboratory Certification Program (NLCP) during the past month, it will be listed at the end and will be omitted from the monthly listing thereafter. This notice is also available on the Internet at https:// www.workplace.samhsa.gov and https://www.drugfreeworkplace.gov.

In FY2012, HHS/ASPR/OPP plans to provide a single source cooperative agreement award to Project Hope to strengthen emergency care delivery in the United States healthcare system through health information and promotion in support of the Homeland Security Presidential Directive-21 (2007) and the National Health Security Strategy (2009) and Implementation Plan (2012). In the past decade, numerous studies have described the delivery of emergency care in the United States as fragmented, overburdened, underfunded, and challenged in its efforts to provide an appropriate level of high quality and cost effective emergency care for Americans on a daily basis and in response to a public health emergency or disaster. These studies have recommended that the emergency care delivery system be redesigned and more broadly integrated into the U.S. healthcare system and healthcare sub-systems. As these changes will have implications for the broader healthcare community, particularly the primary care sub-system, it is essential that both expert and non- expert healthcare professionals, across the healthcare continuum, be informed and engaged in these key policy discussions. Project Hope will plan the publication of a Health Affairs thematic issue that will identify, explore and propose policy options for developing, strengthening and preparing a regionalized, accountable and coordinated system of emergency care that is broadly integrated into the United States healthcare system and capable of responding to a public health emergency or disaster. The project will serve to educate non-emergency medicine healthcare policy professionals and providers about the current state of emergency care delivery in the United States. It will also promote an interdisciplinary dialogue between emergency and other healthcare professionals and providers regarding policy options for the coordinated and integrated delivery of acute unscheduled care that might result from an acute onset of symptoms, exacerbation of a chronic disease, or a public health emergency or disaster. This project will focus on exploring, identifying and proposing policy options regarding workforce, finance, organization and medical care delivery that are essential to redesigning emergency care delivery and supporting its full integration into other healthcare sub- systems as well as the broader U.S. healthcare system. This work will be performed in the context of Homeland Security Presidential Directive-21 and Strategic Objective (4) of the National Health Security Strategy (2009) and Implementation Plan (2012) that seek to foster integrated, scalable healthcare delivery systems that can meet both daily demands and medical surge demands resulting from a public health emergency or disaster.

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 Senior Medicare Patrol Program outcome measurement.

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled ``Acceptance and Filing Review for Premarket Approval Applications (PMAs).'' The purpose of the acceptance and filing reviews is to make a threshold determination about whether an application is administratively complete. This guidance document is intended to clarify the criteria for accepting and filing a PMA, thereby assuring the consistency of our acceptance and filing decisions. This guidance is applicable to original PMAs and PMA panel-track supplements reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research. This draft guidance is not final nor is it in effect at this time.

This notice updates the payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2013 (for discharges occurring on or after October 1, 2012 and on or before September 30, 2013) as required under section 1886(j)(3)(C) of the Social Security Act (the Act). Section 1886(j)(5) of the Act requires the Secretary to publish in the Federal Register on or before the August 1 that precedes the start of each fiscal year, the classification and weighting factors for the IRF prospective payment system's (PPS) case-mix groups and a description of the methodology and data used in computing the prospective payment rates for that fiscal year.

This major proposed rule addresses changes to the physician fee schedule, payments for Part B drugs, and other Medicare Part B payment policies to ensure that our payment systems are updated to reflect changes in medical practice and the relative value of services. It would also implement provisions of the Affordable Care Act by establishing a face-to-face encounter as a condition of payment for certain durable medical equipment (DME) items. In addition, it would implement statutory changes regarding the termination of non-random prepayment review under the Medicare Prescription Drug, Improvement, and Modernization Act of 2003. Finally, this proposed rule also includes a discussion regarding the Chiropractic Services Demonstration program.

The Food and Drug Administration (FDA or Agency) is soliciting comments regarding potential changes to its regulations relating to records and reports for approved new animal drugs. FDA is considering revisions to this regulation to incorporate the requirements of section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA 105). As part of that process, FDA is reviewing other reporting requirements applicable to antimicrobial new animal drug sponsors to determine whether additional information should be reported. Collecting data on antimicrobial drugs used in food-producing animals will assist FDA in tracking antimicrobial use trends and examining how such trends may relate to antimicrobial resistance.

This notice sets forth the hospice wage index for fiscal year (FY) 2013 and will continue the phase-out of the wage index budget neutrality adjustment factor (BNAF), with an additional 15 percent BNAF reduction, for a total BNAF reduction through FY 2013 of 55 percent. The BNAF phase-out will continue with successive 15 percent reductions from FY 2014 through FY 2016. This notice clarifies that providers should report additional diagnoses on hospice claims. This notice also updates the public on the status of hospice payment reform and the quality reporting program.

This Notice sets forth the Indian Health Service policy for conferring with urban Indian organizations and invites comments within 45 days. In March 2010, the Indian Health Care Improvement Act was reauthorized and amended as part of the Patient Protection and Affordable Care Act, Public Law 111-148, as amended by the Health Care and Education Reconciliation Act (together, the Affordable Care Act), Public Law 111-152. One of the changes made to the IHCIA was to create a new requirement that the IHS ``confer'' with UIOs, to the maximum extent practicable, in carrying out the Act as defined by the Indian Health Care Improvement Reauthorization and Extension Act, as enacted and amended by the Affordable Care Act.

The NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) announces an ``International Workshop on Alternative Methods for Leptospira Vaccine Potency Testing: State of the Science and the Way Forward.'' This workshop, the second in a series of specialized vaccine workshops, will review recent advances and innovations in science and technology that can be applied to Leptospira vaccine potency testing. The goal is to promote development of innovative testing methods and approaches that may provide improved accuracy, efficiency, and worker safety and that are more humane and use fewer or no animals. The workshop will also address global acceptance and implementation of scientifically valid alternative methods. The workshop is open to the public at no charge with attendance limited only by the available space; however, advance registration is required (see DATES). NICEATM also invites submission of abstracts for scientific posters for display at the workshop (see SUPPLEMENTARY INFORMATION).

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) 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 and to allow 60 days for public comment in response to the notice. This notice solicits comments concerning collection of information using Form FDA 3794 entitled ``Generic Drug User Fee Cover Sheet.''

The National Institute of Allergy and Infectious Diseases (NIAID), a component of the National Institutes of Health; the Food and Drug Administration (FDA); the Transformational Medical Technologies (TMT); and Biomedical Advanced Research and Development Authority (BARDA) are holding an Animal Model Development Workshop to explore the scientific and regulatory challenges of developing medical countermeasures (MCM) under the ``Animal Rule'' (21 CFR 314.600 for drugs; 21 CFR 601.90 for biological products). The goals of this workshop are to highlight the significant progress made in animal model development for MCMs, review recent case studies of products under development using animal models, and capture lessons learned to inform future animal model development efforts. In addition, the workshop will provide a forum to discuss current challenges and identify potential solutions or mitigation strategies.

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 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 PRA).

The Food and Drug Administration (FDA) is offering an opportunity to affirm outstanding hearing requests pertaining to several dockets. FDA will assume that companies with outstanding hearing requests that do not respond to this notice are no longer interested in pursuing their requests, and will deem the requests withdrawn.

The Health Resources and Services Administration (HRSA) is issuing this notice to inform stakeholders of the revised deadlines for registration of new covered entities and for adding outpatient facilities and contract pharmacy arrangements to the 340B Drug Pricing Program (340B Program).

This notice announces the final Federal share disproportionate share hospital (DSH) allotments for Federal FY (FY) 2010, 2011 and the preliminary Federal share DSH allotments for FY 2012. This notice also announces the final FY 2010, 2011 and the preliminary FY 2012 limits on aggregate DSH payments that States may make to institutions for mental diseases (IMD) and other mental health facilities. In addition, this notice includes background information describing the methodology for determining the amounts of States' FY DSH allotments.

This notice sets forth the States' final allotments available to pay the Medicare Part B premiums for Qualifying Individuals (QIs) for the Federal fiscal year (FY) 2011 and the preliminary QI allotments for FY 2012. The amounts of these QI allotments were determined in accordance with the methodology set forth in regulations and reflect funding for the QI program made available under recent legislation as described in this notice.

The Office of Healthcare Quality is soliciting public comment on a new long-term care facilities strategy/module of the National Action Plan to Prevent Healthcare-Associated Infections: Roadmap to Elimination. To further the HHS mission to protect the health and well- being of the nation, the HHS Steering Committee for the Prevention of Healthcare-Associated Infections has developed a draft comprehensive strategy for preventing and reducing healthcare-associated infections in long-term care facilities. This Phase 3 Long-Term Care Facilities module builds upon and is to be included in the existing National Action Plan to Prevent Healthcare-Associated Infections: Roadmap to Elimination that focuses on reducing healthcare-associated infections (HAIs) in acute care hospitals, ambulatory surgical centers, and end stage renal disease facilities and presents strategies for increasing healthcare personnel influenza vaccination coverage (Phases 1 & 2).

This notice announces a forthcoming meeting of a public advisory committee of the Food and Drug Administration (FDA). The meeting will be open to the public. Name of Committee: Cardiovascular and Renal Drugs Advisory Committee. General Function of the Committee: To provide advice and recommendations to the Agency on FDA's regulatory issues.

The Diabetes Mellitus Interagency Coordinating Committee (DMICC) will hold a meeting on August 16, 2012, from 9:30 to 11:30 a.m. at 31 Center Drive on the NIH campus, Building 31C, Conference Room 6. The meeting is open to the public.

On behalf of the Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM), the NTP Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) requests public comment on an ICCVAM test method nomination for validation studies. The validation studies are proposed to determine the usefulness and limitations of an in vitro test method to identify electrophilic substances that have the potential to produce allergic contact dermatitis (ACD). NICEATM also requests data generated using in vivo and in vitro test methods for assessing ACD hazard potential, including but not limited to guinea pig methods, the murine local lymph node assay, the direct protein reactivity assay, the human cell line activation test, and the KeratinoSens\TM\ assay. Data will be used to develop integrated testing and decision strategies that will also consider incorporation of the nominated test method following adequate validation studies.