Department of Health and Human Services November 2009 – Federal Register Recent Federal Regulation Documents

This final rule temporarily delays the effective date of the November 25, 2008 final rule entitled, ``Medicaid Program; Premiums and Cost Sharing'' and the December 3, 2008 final rule entitled, ``Medicaid Program; State Flexibility for Medicaid Benefit Packages'' until July 1, 2010.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Preliminary Timetable for the Review of Applications for Modified Risk Tobacco Products under the Federal Food, Drug, and Cosmetic Act.'' This guidance is intended for manufacturers, retailers, importers, and FDA staff. The guidance describes FDA's current thinking regarding the appropriate preliminary timetable for its review of applications for Modified Risk Tobacco Products (MRTPs) under the Federal Food, Drug, and Cosmetic Act (the act), as modified by the Federal Smoking Prevention and Tobacco Control Act (Tobacco Control Act).

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: ``Evaluation of the GuideLines Into Decision Support (GLIDES).'' In accordance with the Paperwork Reduction Act of 1995, 44 U.S.C. 3506(c)(2)(A), AHRQ invites the public to comment on this proposed information collection.

This final notice announces our decision to approve the Accreditation Commission for Health Care (ACHC) for recognition as a national accreditation program for hospices seeking to participate in the Medicare or Medicaid programs.

This notice announces a Town Hall meeting to discuss fiscal year (FY) 2011 applications for add-on payments for new medical services and technologies under the hospital inpatient prospective payment system (IPPS). Interested parties are invited to this meeting to present their comments, recommendations, and data regarding whether the FY 2011 new medical services and technologies applications meet the substantial clinical improvement criterion.

The U.S. Department of Health and Human Services (HHS) announces the next federal advisory committee meeting regarding the national health promotion and disease prevention objectives for 2020. This meeting will be open to the public and will be held online via WebEx software. The Secretary's Advisory Committee on National Health

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Residual Solvents in Drug Products Marketed in the United States.'' On July 1, 2008, the United States Pharmacopeia (USP) published a new test requirement for the control of residual solvents, General Chapter ``Residual Solvents,'' which replaced USP General Chapter ``Organic Volatile Impurities.'' The change affects all compendial drug products marketed in the United States. This guidance reflects FDA's recommendations on how to comply with those USP changes.

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: ``Spreading Techniques to Radically Reduce Antibiotic Resistant Bacteria (Methicillin Resistant Staphylococcus aureus, or MRSA).'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 350 1-3520, AHRQ invites the public to comment on this proposed information collection.

This notice announces to independent accreditation organizations an opportunity to submit applications to participate in the advanced diagnostic imaging supplier accreditation program as a designated accreditation organization. Advanced diagnostic imaging accreditation is required for suppliers furnishing the technical component (TC) of advanced diagnostic imaging services. This notice contains information on accreditation application guidelines for CMS approval of suppliers who furnish the TC of advanced diagnostic imaging services.

The Department of Health and Human Services (HHS) is issuing this Notice of Proposed Rulemaking (NPRM) to obtain input from stakeholders and other interested parties. This is a proposal to amend the rule governing the separation that must exist between a recipient of HHS funds to implement HIV/AIDS programs and activities under the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003 and an affiliate organization that engages in activities that are not consistent with a policy opposing prostitution and sex trafficking. The proposed rule relaxes the criteria for recipient affiliate separation, and simplifies the process for compliance with the statutory requirement that recipients of HHS Leadership Act HIV/ AIDS funds have a policy explicitly opposing prostitution and sex trafficking. This proposal eliminates the requirement that recipients prepare and file additional documentation specifically to demonstrate adherence to this policy. The documentation will instead consist of a statement in the awarding document to which the prime recipient must agree in order to receive Leadership Act HIV/AIDS funds.

Section 103 (d) of the Americans with Disabilities Act of 1990, Public Law 101-336, requires the Secretary to publish a list of infectious and communicable diseases that are transmitted through handling the food supply and to review and update the list annually. The Centers for Disease Control and Prevention (CDC) published a final list on August 16, 1991 (56 FR 40897) and updates on September 8, 1992 (57 FR 40917); January 13, 1994 (59 FR 1949); August 15, 1996 (61 FR 42426); September 22, 1997 (62 FR 49518-9); September 15, 1998 (63 FR 49359), September 21, 1999 (64 FR 51127); September 27, 2000 (65 FR 58088), September 10, 2001 (66 FR 47030), and September 27, 2002 (67 FR 61109), September 26, 2006 (71 FR 56152), and November 17, 2008 (73 FR 67871). The final list has been reviewed in light of new information and has been revised as set forth below.

The Food and Drug Administration (FDA) (the agency) is issuing an order under the Federal Food, Drug, and Cosmetic Act (the act) permanently debarring Niaja Kane from providing services in any capacity to a person that has an approved or pending drug product application. We base this order on a finding that Ms. Kane was convicted of felonies under Federal law for conduct relating to the regulation of a drug product under the act. Ms. Kane was given notice of the proposed permanent debarment and an opportunity to request a hearing within the timeframe prescribed by regulation. As of September 20, 2009, Ms. Kane failed to respond. Ms. Kane's failure to respond constitutes a waiver of her right to a hearing concerning this action.

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADA provides for use of the same dose levels approved for single-ingredient Type C medicated feeds containing melengestrol acetate, monensin, or tylosin phosphate for heifers fed in confinement for slaughter in three-way, combination drug Type C medicated feeds containing melengestrol acetate, monensin, and tylosin phosphate.

The Food and Drug Administration (FDA) is proposing to amend its regulations regarding the declaration of certified color additives on the labels of animal food including animal feeds and pet foods. FDA is proposing this amendment in response to the Nutrition Labeling and Education Act of 1990 (the 1990 amendments), which amended the Federal Food, Drug, and Cosmetic Act (the act) by requiring, among other things, the listing on food labels of the common or usual names of all color additives required to be certified by FDA. An additional purpose of this amendment is to make these regulations consistent with the regulations regarding the declaration of certified color additives on the labels of human food. The proposed rule also suggests appropriate terminology for the declaration of certification-exempt color additives on the labels of animal food.

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 for public comment in response to the notice. This notice solicits comments on requirements for recordkeeping and reports concerning experience with approved new animal drugs, specifically on new data elements to be used in revised versions of Forms FDA 1932 and 1932a. The information contained in the reports required by this regulation enables FDA to monitor the use of new animal drugs after approval and to ensure their continued safety and efficacy.

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry 191 entitled ``Changes to Approved NADAsNew NADAs vs. Category II Supplemental NADAs.'' This guidance is intended to assist sponsors who wish to apply for approval of changes to approved new animal drugs that require FDA to reevaluate safety and/or effectiveness data. The goal of this guidance is to create greater consistency in how such applications are handled by sponsors and by FDA's Center for Veterinary Medicine (CVM).

The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original abbreviated new animal drug application (ANADA) filed by First Priority, Inc. The ANADA provides for use of Sulfadimethoxine Soluble Powder in medicated drinking water of cattle, chickens, and turkeys for the treatment of various bacterial infections.

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a pre- clearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. As required by section 3507(a)(1)(D) of the PRA95, the proposed information collection has been submitted to the Office of Management and Budget (OMB) for review and approval.

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 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 reporting of biological product deviations (BPDs) and human cells, tissues, and cellular and tissue-based product (HCT/P) deviations, and Form FDA 3486 and Addendum 3486A.

The Food and Drug Administration (FDA) is announcing an amendment to the notice of meeting of the Anti-Infective Drugs Advisory Committee. This meeting was announced in the Federal Register of October 26, 2009 (74 FR 55057). The amendment is being made to reflect a change in the Location portion of the document. There are no other changes.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Heart, Lung, and Blood Institute (NHLBI), the National Institutes of Health 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 Wednesday, July 29, 2009, Volume 74, Number 144 and allowed 60-days for public comment. No public comments were received. The purpose of this notice is to allow an additional 30 days for public comment.

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 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 Sauflon Pharmaceuticals Ltd. has filed a petition proposing that the color additive regulations be amended to provide for the safe use of disodium 1-amino-4-[[4-[(2-bromo-1-oxoallyl)amino]-2- sulfonatophenyl]amino]-9,10-dihydro-9,10-dioxoanthracene-2-su lfonate (CAS Reg. No. 70209-99-3) as a color additive in contact lenses.

In compliance with Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995 which requires 60 day advance opportunity for public comment on proposed information collection projects, the Indian Health Service (IHS) is publishing for comment a summary of a proposed information collection to be submitted to the Office of Management and Budget (OMB) for review.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), will hold a public meeting concerning the proposed rule that was published in the Federal Register on Friday, October 30, 2009. The proposed rule proposes to establish total inward leakage (TIL) requirements for half- mask air-purifying particulate respirators approved by NIOSH. The proposed new requirements specify TIL minimum performance requirements and testing to be conducted by NIOSH and respirator manufacturers to demonstrate that these respirators, when selected and used correctly, provide effective respiratory protection to intended users against toxic dusts, mists, fumes, fibers, and biological and infectious aerosols (e.g. influenza A(H5N1), severe acute respiratory syndrome (SARS) coronavirus, and Mycobacterium tuberculosis).

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.

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Biodefense Science Board (NBSB) will hold a teleconference meeting. The meeting is open to the public. Pre- registration is NOT required, however, individuals who wish to participate in the public comment session should e-mail NBSB@HHS.GOV to RSVP.

The Department of Health and Human Services (HHS) establishes the standards for Federal workplace drug testing programs under authority of Section 503 of Public Law 100-71, 5 U.S.C. Section 7301 and Executive Order No. 12564. As required, HHS published the Mandatory Guidelines for Federal Workplace Drug Testing Programs (Guidelines) in the Federal Register on April 11, 1988 (53 FR 11979). The Substance Abuse and Mental Health Services Administration (SAMHSA) subsequently revised the Guidelines on June 9, 1994 (59 FR 29908), on September 30, 1997 (62 FR 51118), on November 13, 1998 (63 FR 63483), on April 13, 2004 (69 FR 19644) and on November 25, 2008 (73 FR 71858) with an effective date of May 1, 2010 (correct effective date published on December 10, 2008; 73 FR 75122). The Guidelines establish comprehensive standards for all aspects of the Federal workplace drug testing program, including the requirement for all urine specimens to be collected using chain of custody procedures to document specimen integrity and security from the time of collection until receipt by the ``test facility.'' To ensure uniformity among all Federal agency workplace drug testing programs and procedures, the Guidelines require agencies to use an Office of Management and Budget (OMB) approved Federal Custody and Control Form (Federal CCF) for their programs. Additionally, the Department of Transportation (DOT) requires its regulated industries to use the Federal CCF.

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 National Heart, Lung, and Blood Institute (NHLBI), 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 National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) is conducting an evaluation of source capture ventilation systems (SCVS) units for use in nail salons, including downdraft vented nail tables and portable SCVS. This notice invites developers, manufacturers, distributors, and vendors of downdraft vented nail tables and portable nail salon SCVS that feature local exhaust recirculation to submit new, unused units for evaluation. A supply of filters sufficient to provide ventilation during 6 months of daily operation (as recommended by the developer or manufacturer), should be submitted to the NIOSH laboratory in Cincinnati, OH, together with the table or portable SCVS.

The Food and Drug Administration (FDA) is announcing the reopening until November 15, 2010 of a public docket to receive information and comments on laser-assisted in situ keratomileusis (LASIK) devices.

The Department of Health and Human Services (HHS or the Department) is removing its regulation implementing the Governmentwide common rule on drug-free workplace requirements for financial assistance, and issuing a new regulation to adopt Office of Management and Budget (OMB) guidance. This regulatory action implements the OMB's initiative to streamline and consolidate into one title of the CFR all Federal regulations on drug-free workplace requirements for financial assistance. These changes constitute an administrative simplification that would make no substantive change in HHS policy or procedures for drug-free workplace.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``E7 Studies in Support of Special Populations: Geriatrics; Questions & Answers.'' The draft guidance was prepared under the auspices of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH). The draft questions and answers

The Food and Drug Administration (FDA) is extending to February 5, 2010, the comment period for the proposed rule that appeared in the Federal Register of September 23, 2009. In the proposed rule, FDA requested comments on current good manufacturing practice (CGMP) requirements applicable to combination products. The agency is taking this action in response to requests for an extension to allow interested persons additional time to submit comments.

This final rule sets forth an update to the Home Health Prospective Payment System (HH PPS) rates; 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 home health agencies effective January 1, 2010. This rule also updates the wage index used under the HH PPS. In addition, this rule changes the HH PPS outlier policy, requires the submission of OASIS data as a condition for payment under the HH PPS, implements a revised Outcome and Assessment Information Set (OASIS-C) for episodes beginning on or after January 1, 2010, and implements a Consumer Assessment of Healthcare Providers and Systems (CAHPS) Home Health Care Survey (HHCAHPS) affecting payment to HHAs beginning in CY 2012. Also, this rule makes payment safeguards that will improve our enrollment process, improve the quality of care that Medicare beneficiaries receive from HHAs, and reduce the Medicare program's vulnerability to fraud. This rule also adds clarifying language to the ``skilled services'' section and Conditions of Participation (CoP) section of our regulations. This rule also clarifies the coverage of routine medical supplies under the HH PPS.

This is a notice in accordance with 35 U.S.C. 209(e) and 37 CFR 404.7(a)(1)(i) that the Technology Transfer Office, Centers for Disease Control and Prevention (CDC), Department of Health and Human Services (DHHS), is contemplating the granting of an exclusive worldwide license to practice the invention embodied in the patent application referred to below to International Rollforms, Inc., having a place of business in Deptford, New Jersey. CDC intends to grant rights to practice this invention to no other licensees. The patent rights in this invention have been assigned to the government of the United States of America. The patent to be licensed is:

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion,'' dated November 2009. This guidance is intended for establishments that collect Whole Blood and blood components intended for transfusion. The document provides recommendations for testing of donations of Whole Blood and blood components for West Nile Virus (WNV) using an FDA-licensed donor screening assay. FDA believes that the use of a licensed nucleic acid test (NAT) will reduce the risk of transmission of WNV, and therefore recommends use of a licensed NAT to screen donors of Whole Blood and blood components intended for transfusion. The guidance announced in this notice finalizes the recommendations as to Whole Blood and blood components contained in the draft guidance ``Guidance for Industry: Use of Nucleic Acid Tests to Reduce the Risk of Transmission of West Nile Virus from Donors of Whole Blood and Blood Components Intended for Transfusion and Donors of Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps),'' dated April 2008. The recommendations as to HCT/P donor specimens contained in the draft guidance are not being finalized at this time because FDA believes additional public discussion is warranted.

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 National Cancer Institute (NCI), 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.