Department of Health and Human Services 2010 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for FDA staff entitled ``Compliance Policy Guide Sec. 690.800 Salmonella in Animal Feed'' (the draft CPG). The draft CPG, when finalized, is intended to provide guidance for FDA staff on regulatory policy relating to animal feed or feed ingredients that come in direct contact with humans, such as pet food and pet treats, contaminated with Salmonella and also on regulatory policy relating to animal feed or feed ingredients contaminated with a Salmonella serotype that is pathogenic to the target animal for the animal feed.

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 Department of Health and Human Services (HHS) notifies Federal agencies of the laboratories currently certified to meet the standards of Subpart C 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), on September 30, 1997 (62 FR 51118), and on April 13, 2004 (69 FR 19644).

HHS gives notice of a decision to designate a class of employees from the University of Rochester Atomic Energy Project in Rochester, New York, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from the Mound Plant in Miamisburg, Ohio, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 14, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from the Downey Facility in Los Angeles County, California, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

HHS gives notice of a decision to designate a class of employees from BWX Technologies, Inc., in Lynchburg, Virginia, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On July 13, 2010, the Secretary of HHS designated the following class of employees as an addition to the SEC:

The Food and Drug Administration (FDA) is announcing the availability of a report entitled ``A New Approach to Targeting Inspection Resources and Identifying Patterns of Adulteration: The Reportable Food Registry.'' The report presents FDA's experience with the Reportable Food Registry (RFR or the Registry) from the opening of the Reportable Food electronic portal on September 8, 2009, until March 31, 2010.

Section 1101 of Title I of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) requires that the Secretary establish, either directly or through contracts with States or nonprofit private entities, a temporary high risk health insurance pool program to provide affordable health insurance coverage to uninsured individuals with pre-existing conditions. This program will continue until January 1, 2014, when Exchanges established under sections 1311 and 1321 of the Affordable Care Act will be available for individuals to obtain health insurance coverage. This interim final rule implements requirements in section 1101 of the Affordable Care

This notice requests comments from the public for our consideration in developing the Secretary's recommendations for legislative changes to improve the quality of care provided to children under Medicaid and the Children's Health Insurance Program, including recommendations for quality reporting by the States. The Children's Health Insurance Program Reauthorization Act of 2009 (CHIPRA) requires the Secretary of Health and Human Services to provide to Congress recommendations for legislative changes to improve the quality of care provided to children under Medicaid and the Children's Health Insurance Program.

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: ``Eisenberg Center Voluntary Customer Survey Generic Clearance for the Agency for Health Care Research and Quality.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of General Medical Sciences (NIGMS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on May 18, 2010, pages 27789-27790, and allowed 60 days for public comment. One comment was received on 6/25/2010. The public respondent requested that eligibility for this program be offered to American citizens only. As stated in A.1., Justification, of the Supporting Statement A, applicants for this program must be U.S. citizens or permanent residents of the United States who have been awarded a terminal degree, or who have been certified by a university as meeting all the requirements leading to a doctorate may be hired as PRAT Fellows. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number.

This is notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i), that the National Institutes of Health (NIH), Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the invention embodied in U.S. Patent Application No. 60/336,394, filed on October 22, 2001 (HHS Ref. No. E-064-2004/0-US-01); PCT Application No. PCT/US02/033875, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-PCT-02); U.S. Patent Application No. 10/279,129, filed on October 22, 2002 (HHS Ref. No. E- 064-2004/0-US-03); Japanese Patent Application No. 2003-537565, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-JP-04); Mexican Patent No. 250445, filed on October 22, 2002 and granted on October 16, 2007 (HHS Ref. No. E-064-2004/0-MX-05); Polish Patent Application No. P- 374301, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-PL-6); Canadian Patent Application No. 2464277, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-CA-07); European Patent Application No. 02793811.7, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0-EP- 08); U.S. Patent No. 7,183,254, filed on July 18, 2003 and granted on 2/27/2007 (HHS Ref. No. E-064-2004/0-US-09); U.S. Patent Application No. 11/606,805, filed on October 29, 2006 (HHS Ref. No. E-064-2004/0- US-10); Mexican Patent Application No. 2007/006095, filed on May 14, 2007 (HHS Ref. No. E-064-2004/0-MX-11); Australian Patent Application No. 2002359288, filed on October 22, 2002 (HHS Ref. No. E-064-2004/0- AU-12); Hong Kong Patent Application No. 4106574.7, filed on September 1, 2004 (HHS Ref. No. E-064-2004/0-HK-13); European Patent Application No. 10165256.8, filed on June 8, 2010 (HHS Ref. No. E-064-2004/0-EP- 14); and Japanese Patent Application No. 2010-137501, filed on June 16, 2010 (HHS Ref. No. E-064-2004/0-JP-15), all entitled ``Use of Leptin for Treating Human Lipoatrophy and Method of Determining Predisposition to Said Treatment'', to Amylin Pharmaceuticals, Inc., having a place of business in San Diego, California, U.S.A. The patent rights in this invention have been assigned to the United States of America, the University of Texas Southwestern Medical Center at Dallas, and Amgen, Inc.

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 reopening until September 7, 2010, the comment period for the notice that appeared in the Federal Register of April 5, 2010 (75 FR 17143). In the notice, FDA requested comments on draft guidance documents for 11 neurological and physical medicine devices. FDA is reopening the comment period to allow further comment and to receive any new information.

The Department of Health and Human Services (HHS) is issuing this final rule to complete the adoption of an initial set of standards, implementation specifications, and certification criteria, and to more closely align such standards, implementation specifications, and certification criteria with final meaningful use Stage 1 objectives and measures. Adopted certification criteria establish the required capabilities and specify the related standards and implementation specifications that certified electronic health record (EHR) technology will need to include to, at a minimum, support the achievement of meaningful use Stage 1 by eligible professionals, eligible hospitals, and/or critical access hospitals (hereafter, references to ``eligible hospitals'' in this final rule shall mean ``eligible hospitals and/or critical access hospitals'') under the Medicare and Medicaid EHR Incentive Programs. Complete EHRs and EHR Modules will be tested and certified according to adopted certification criteria to ensure that they have properly implemented adopted standards and implementation specifications and otherwise comply with the adopted certification criteria.

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 on the paperwork requirements for the proposed Pet Event Tracking Network (PETNet) cooperative Federal and State initiative.

This proposed notice with comment period acknowledges the receipt of an application from Det Norske Veritas Healthcare (DNVHC) for recognition as a national accrediting organization for critical access hospitals (CAHs) that wish to participate in the Medicare or Medicaid programs.

A hospital has requested a waiver of statutory requirements that would otherwise require the hospital to enter into an agreement with its designated Organ Procurement Organization (OPO). The request was made in accordance with section 1138(a)(2) of the Social Security Act (the Act). This notice requests comments from OPOs and the general public for our consideration in determining whether we should grant the requested waiver.

The Food and Drug Administration (FDA) is correcting a notice that appeared in the Federal Register of July 14, 2010 (75 FR 40843). The document announced the availability of a draft guidance entitled ``Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions; Annex 13: Bulk Density and Tapped Density of Powders General Chapter.'' The document was published with an incorrect docket number. This document corrects that error.

This document contains interim final regulations implementing the requirements regarding internal claims and appeals and external review processes for group health plans and health insurance coverage in the group and individual markets under the Patient Protection and Affordable Care Act. The regulations will generally affect health insurance issuers; group health plans; and participants, beneficiaries, and enrollees in health insurance coverage and in group health plans. The regulations provide plans and issuers with guidance necessary to comply with the law.

Sections 474(a)(3)(C) and (D) of the Social Security Act (the Act) provide States with the opportunity to access additional funding through title IV-E to plan, design, develop, implement, and operate a Statewide Automated Child Welfare Information System (SACWIS). The regulations at 45 CFR 1355.50-1355.57 were established in response to this legislation and were issued on December 22, 1993.

The Administration on Aging (AoA) is announcing that the proposed collection of information listed below has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. This collection of information relates to the Area Agency on Aging and Local Service Provider Study.

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: ``Reduction of Clostridium difficile Infections in a Regional Collaborative of Inpatient Healthcare Settings through Implementation of Antimicrobial Stewardship.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.

This proposed rule would set forth an update to the Home Health Prospective Payment System (HH PPS) rates, including: The national standardized 60-day episode rates, the national per-visit rates, the non-routine medical supply (NRS) conversion factors, and the low utilization payment amount (LUPA) add-on payment amounts, under the Medicare prospective payment system for HHAs effective January 1, 2011. This rule also proposes to update the wage index used under the HH PPS and, in accordance with The Affordable Care Act of 2010 (The Affordable Care Act), Public Law 111-148, to update the HH PPS outlier policy. In addition, this rule proposes changes to the home health agency (HHA) capitalization requirements. This rule further proposes to add clarifying language to the ``skilled services'' section. Finally, this rule incorporates new legislative requirements regarding face-to-face encounters with providers related to home health and hospice care.

Pursuant to Section 5602 of the ACA, HRSA plans to establish a comprehensive methodology and criteria for Designation of MUPs and Primary Care HPSAs [under Sections 330(b)(3) and 332 of the Public Health Service (PHS) Act, respectively], using a Negotiated Rulemaking process. To do this, HRSA announces the establishment of the Negotiated Rulemaking Committee on the Designation of Medically Underserved Populations and Health Professions Shortage Areas.

This notice with comment period sets forth an update to the payment rates used under the prospective payment system for skilled nursing facilities for fiscal year 2011, and implements section 10325 of the Patient Protection and Affordable Care Act.

This notice updates the payment rates for inpatient rehabilitation facilities (IRFs) for Federal fiscal year (FY) 2011 (for discharges occurring on or after October 1, 2010 and on or before September 30, 2011) 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.

The Administration on Aging (AoA) 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 Supplemental Form to the Financial Status Report for all AoA Title III Grantees.

The Food and Drug Administration (FDA) is withdrawing approval of 27 new drug applications (NDAs) and 58 abbreviated new drug applications (ANDAs) from multiple applicants. The holders of the applications notified the agency in writing that the drug products were no longer marketed and requested that the approval of the applications be withdrawn.

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 information collection provisions in the guidance document entitled ``Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition.''

In accordance with the requirements of the Privacy Act of 1974 (5 U.S.C. 552a), as amended, the Office of Child Support Enforcement (OCSE) is publishing notice of a new system of records, entitled ``Federal Parent Locator Service (FPLS) Child Support Services Portal,'' System No. 09-80-0387.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the National Institutes of Health (NIH), National Institutes of Environmental Health Sciences (NIEHS), National Toxicology Program (NTP); and the NIH, National Human Genome Research Institute (NHGRI), NIH Chemical Genomics Center (NCGC); and the Environmental Protection Agency, Office of Research and Development.

The Food and Drug Administration (FDA) is announcing the availability of a draft recommendation for the revision of the permitted daily exposure (PDE) for the solvent cumene according to the maintenance procedures for the guidance for industry entitled ``Q3C: Impurities: Residual Solvents.'' The draft recommendation was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH).

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 paperwork associated with designation under the Minor Use and Minor Species (MUMS) Animal Health Act of 2004.

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 an information request regarding the use of menthol in cigarettes.

This is a notice, in accordance with 35 U.S.C. 209(c)(1) and 37 CFR Part 404.7(a)(1)(i), that the National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to practice the inventions embodied in US Patent Application 61/241,620 entitled ``Development of an Immunotoxin in Which All B-Cell Epitopes Have Been Removed and Which Has High Cytotoxic Activity'' [HHS Ref. E-269-2009/0-US-01], US Patent Application 60/969,929 entitled ``Deletions in Domain II of Pseudomonas Exotoxin A That Reduce Non-Specific Toxicity'' [HHS Ref. E-292-2007/0- US-01], US Patent Application 60/703,798 entitled ``Mutated Pseudomonas Exotoxins with Reduced Antigenicity'' [HHS Ref. E-262-2005/0-US-01], and all continuing applications and foreign counterparts, to MedImmune, LLC. This license may also include non-exclusive rights to US Patent Application 60/525,371 entitled ``Mutated Anti-CD22 Antibodies and Immunoconjugates'' [HHS Ref. E-046-2004/0-US-01], US Patent Application 60/325,360 entitled ``Mutated Anti-CD22 Antibodies with Increased Affinity to CD22 Expressing Leukemia Cells'' [HHS Ref. E-129-2001/0-US- 01], US Patent Application 60/041,437 entitled ``Recombinant Immunotoxins Targeted to CD22 Bearing Cells and Tumors'' [HHS Ref. E- 059-1997/0-US-01], US Patent 5,747,654 entitled ``Recombinant Disulfide-Stabilized Polypeptide Fragments Having Binding Specificity'' [HHS Ref. E-163-1993/0-US-01], PCT application PCT/US96/16327 entitled ``Immunotoxin Containing A Disulfide-Stabilized Antibody Fragment'' [HHS Ref. E-163-1993/2-PCT-01], and all continuing applications and foreign counterparts. The patent rights in these inventions have been assigned to and/or exclusively licensed to the Government of the United States of America.

The Food and Drug Administration (FDA) is amending the regulations for food additives permitted in feed and drinking water of animals to provide for the safe use of ammonium formate as an acidifying agent in swine feed. This action is in response to a food additive petition filed by Kemira Oyj of Finland.

In accordance with section 10(a)(2) of the Federal Advisory Committee Act (Pub. L. 92-463), as amended, the Department of Health and Human Services is hereby giving notice that the Advisory Commission on Childhood Vaccines (ACCV) will hold a special meeting, to be held by teleconference. This meeting will be equivalent to an in-person meeting and will be open to the public.

The Office of the Assistant Secretary for Planning Evaluation (ASPE) is developing a national inventory of comparative effectiveness research (CER) and CER-related information. This initiative is driven by the American Recovery and Reinvestment Act of 2009 (ARRA) which provided $1.1 billion for research and development in the area of CER. ARRA allocated $400 million to the Office of the Secretary (OS) in the U.S. Department of Health and Human Services (HHS), $400 million to the National Institutes of Health (NIH), and $300 million to the Agency for Healthcare Research and Quality. ARRA also established the Federal Coordinating Council for CER, which, after significant public input, developed a strategic framework and recommended high-level priorities for OS funds. While the FCC's Report to Congress drew on an initial CER inventory focused on federal investments, the process of cataloguing CER activities and infrastructure will be critical to tracking ongoing and future investments in CER. An important component of this effort is creating an inventory of CER to ensure that patients, clinicians, and other decision makers can identify and locate relevant CER in a timely manner.

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.