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

The Food and Drug Administration (FDA) is announcing its determination that Cysteine Hydrochloride Injection, USP, 7.25% (Cysteine HCl), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Cysteine HCl if all other legal and regulatory requirements are met.

The Food and Drug Administration (FDA) is providing notice of a memorandum of understanding (MOU) between FDA and the International Anesthesia Research Society (IARS). The purpose of this MOU is to establish a framework for collaboration between FDA and IARS and to support their shared interest of promoting the safe use of anesthetics and sedatives in children.

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 reinstatement 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 standardized format and content requirements for the labeling of over-the-counter (OTC) drug products.

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: ``Reductions of Infection Caused by Carbapenem Resistant Enterobacteriaceae (KPC) Producing Organisms through the Application of Recently Developed CDC/HICPAC Recommendations.'' 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 document corrects technical errors that appeared in the supplementary proposed rule entitled ``Medicare Program; Supplemental Proposed Changes to the Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and Supplemental Proposed Fiscal Year 2011 Rates'' which was filed for public inspection on May 21, 2010.

The IHS announces the award of supplemental projects under the existing single source cooperative agreement award to the NIHB, Inc. The Office of Direct Service and Contracting Tribes (ODSCT) has designated supplemental funds for the single source award to the NIHB to further health program objectives in the American Indian/Alaska Natives (AI/AN) community with outreach and education efforts in the interest of improving Indian health care. The NIHB is the only national Indian organization with expertise on the variety of issues related to the provision of health care to the Indian population.

The Food and Drug Administration (FDA) is announcing the withdrawal, without prejudice to a future filing, of a food additive petition (FAP 7M4770) proposing that the food additive regulations be amended to provide for the safe use of ultraviolet radiation for the reduction of pathogens and other microorganisms in aqueous sugar solutions and potable water intended for use in food production.

In accordance with the requirements of the Privacy Act of 1974, as amended, this notice announces the renewal of an existing CMP between CMS, the Internal Revenue Service (IRS), and the Social Security Administration (SSA). We have provided information about the matching program in the SUPPLEMENTARY INFORMATION section below. The Privacy Act provides an opportunity for interested persons to comment on the matching program. We may defer implementation of this matching program if we receive comments that persuade us to defer implementation. See ``Effective Dates'' section below for comment period.

This notice contains the final wage indices, hospital reclassifications, payment rates, impacts, and other related tables effective for the fiscal year (FY) 2010 hospital inpatient prospective payment systems (IPPS) and rate year 2010 long-term care hospital (LTCH) prospective payment system (PPS). The rates, tables, and impacts included in this notice reflect changes required by or resulting from the implementation of several provisions of the Patient Protection and Affordable Care Act and the Health Care and Education Reconciliation Act of 2010. These provisions require the extension of the expiration date for certain geographic reclassifications and special exception wage indices through September 30, 2010; and certain market basket updates for the IPPS and LTCH PPS.

In accordance with the requirements of the Privacy Act of 1974, CMS is proposing to modify or alter existing system of records titled ``National Provider System,'' System No. 09-70-0008. Under the authority of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Public Law (Pub. L.) 104-191, this system was established and published in the Federal Register (FR) at 63 FR 40297 (July 28, 1998). The system name ``National Provider System'' describes the original system designed to enumerate individual health care providers and maintain the information submitted in their application, the National Provider Identifier (NPI) Application/Update Form (Form CMS- 10114). Expectation of the adoption of a standard unique health identifier for health plans would broaden the function of the system to enable it to assign health plan identifiers to health plans; as a result, the name of the system is proposed to read: the ``National Plan and Provider Enumeration System (NPPES).'' Although the Federal Register Notice (July 28, 1998) stated that both organizational providers and providers who are individuals are included in the NPS database, and the system may be expanded in the future to include enumerated health plans, this system of records will be applicable only to the collection and maintenance of information about enumerated health care providers who are individuals (e.g., physicians and non- physician practitioners), containing the information they submitted on their NPI applications and their assigned NPI.

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.

This final rule revises the November 25, 2008 final rule entitled, ``Medicaid Programs; Premiums and Cost Sharing (73 FR

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 National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) announces the following public meeting: ``Partnerships to Advance the National Occupational Research Agenda (NORA)''.

This notice announces a public meeting to receive comments and recommendations (including accompanying data on which recommendations are based) from the public on the appropriate basis for establishing payment amounts for a specified list of new Clinical Procedural Terminology (CPT) codes for clinical laboratory tests in calendar year (CY) 2011. The meeting provides a forum for interested parties to make presentations and submit written comments on the new codes that will be included in Medicare's Clinical Laboratory Fee Schedule for CY 2011, which will be effective on January 1, 2011. The development of the codes for clinical laboratory tests is largely performed by the CPT Editorial Panel and will not be further discussed at the meeting.

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 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.

In accordance with the Privacy Act of 1974 (5 U.S.C. 522a), as amended, OCSE is publishing notice of a computer matching program between OCSE and state agencies administering the Temporary Assistance for Needy Families (TANF) program.

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC), will hold a second public meeting concerning the proposed rule for Total Inward Leakage Requirements for Respirators that was published in the Federal Register on Friday, October 30, 2009 (74 FR 56141). The purpose of the meeting is to allow participants to make presentations to NIOSH, share results of any new research that may be available or in process in the area of filtering facepiece or other half-mask respirator inward leakage measurement, and offer any additional comments on the anticipated economic impact of the proposed rule.

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated May 2010. The guidance announced in this notice provides blood collecting establishments and manufacturers of plasma derivatives with comprehensive FDA recommendations intended to minimize the possible risk of transmission of CJD and vCJD from blood and blood products. This guidance document amends the January 2002 guidance document of the same title by: Incorporating donor deferral recommendations for donors who have received a transfusion of blood or blood components in France since 1980, providing updated scientific information on CJD and vCJD, revising labeling recommendations for Whole Blood and blood components intended for transfusion, and recognizing AABB's full Donor History Questionnaire Version 1.3 as an acceptable mechanism for collection of donor history information. The guidance announced in this notice supersedes the guidance document entitled ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products'' dated January 2002 (2002 guidance), and the draft guidance document entitled ``Draft Guidance for Industry: Amendment (Donor Deferral for Transfusion in France Since 1980) to ``Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease (CJD) and Variant Creutzfeldt-Jakob Disease (vCJD) by Blood and Blood Products''' dated August 2006 (2006 draft guidance).

This proposed rule would revise the conditions of participation (CoPs) for both hospitals and critical access hospitals (CAHs). These revisions would allow for a new credentialing and privileging process for physicians and practitioners providing telemedicine services.

The Office for Human Research Protections (OHRP), a program office in the Office of Public Health and Science, Department of Health and Human Services (HHS), is seeking nominations of qualified candidates to be considered for appointment as members of the Secretary's Advisory Committee on Human Research Protections (SACHRP). SACHRP provides advice and recommendations to the Secretary, HHS, and the Assistant Secretary for Health on matters pertaining to the continuance and improvement of functions within the authority of HHS directed toward protections for human subjects in research. SACHRP was established by the Secretary, HHS, on October 1, 2002. OHRP is seeking nominations of qualified candidates to fill three positions on the Committee membership which will become available on March 1, 2011.

This notice with comment period contains a draft model agreement for use by the Secretary and manufacturers under the Medicare Coverage Gap Discount Program established by section 3301 of the Patient Protection and Affordable Care Act, as amended by section 1101 of the Health Care and Education Reconciliation Act of 2010. Under the agreement, manufacturers of applicable covered Part D drugs must provide applicable discounts to applicable Medicare beneficiaries for applicable covered Part D drugs while in the coverage gap beginning in 2011. It also announces the June 1, 2010 public meeting regarding the draft model agreement.

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry 188 entitled ``Data Elements for Submission of Veterinary Adverse Event Reports to the Center for Veterinary Medicine.'' The purpose of this draft guidance is to assist sponsors or non-applicants with filling out form FDA 1932, ``Veterinary Adverse Drug Reaction, Lack of Effectiveness, Product Defect Report,'' as required by FDA regulations.

The Secretary's Advisory Committee on Genetics, Health, and Society (SACGHS) is requesting public comment on a draft report to the Secretary of Health and Human Services (HHS) on genetics education and training of health care professionals, public health providers, and consumers. A copy of the draft report is available electronically at https://oba.od.nih.gov/SACGHS/sacghs_public_comments.html. A copy may also be obtained by contacting Kathryn Camp at campkm@od.nih.gov or 301-496-9838.

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.

As stipulated by the Federal Advisory Committee Act, the U.S. Department of Health and Human Services is hereby giving notice that the Advisory Committee on Blood Safety and Availability (ACBSA) will hold a meeting. The meeting will be open to the public.

The Department of Health and Human Services (HHS or the Department) and the HHS Public Health Service (PHS), proposes to amend its regulations on the Responsibility of Applicants for Promoting Objectivity in Research for which PHS Funding is Sought and Responsible Prospective Contractors. Since the promulgation of the regulations in 1995, biomedical and behavioral research and the resulting interactions among Government, research institutions, and the private sector have become increasingly complex. This complexity, as well as a need to strengthen accountability, have led to the proposal of amendments that would expand and add transparency to investigator disclosure of significant financial interests, enhance regulatory compliance and effective institutional oversight and management of investigators' financial conflicts of interests, as well as NIH's compliance oversight.

In accordance with the requirements of the Privacy Act SAMHSA proposes to add a new routine use to its inventory of SORNs subject to the Privacy Act of 1974 (Title 5 United States Code [U.S.C.] 552a) authorizing disclosure of individually identifiable information to assist in efforts to respond to a suspected or confirmed breach of the security or confidentiality of information maintained in these systems of records. The new routine use will be prioritized in the next consecutive numbered order of routine uses in each system notice and will be included in the next published notice as part of SAMHSA's normal SORN review process.

The Food and Drug Administration (FDA) is extending to July 23, 2010, the comment period for a notice that appeared in the Federal Register of February 23, 2010 (75 FR 8086). In that notice, FDA established a docket to obtain comments and information about current practices and conditions for the production and packing of fresh produce. The agency is extending this comment period to give interested parties additional time to provide the information requested by FDA in that notice.

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 Healthcare 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.

The Office of Public Health and Science is soliciting public comment on the HHS Interagency Workgroup on Multiple Chronic Conditions draft ``HHS Strategic Framework on Multiple Chronic Conditions.''

HHS gives notice concerning the final effect of the decision to designate a class of employees from Westinghouse Electric Corp., Bloomfield, New Jersey, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 5, 2010, 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:

HHS gives notice concerning the final effect of the decision to designate a class of employees from the Nevada Test Site as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On April 5, 2010, 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:

HHS 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 Mound site in Miamisburg, 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:

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 Institute of General Medical Sciences (NIGMS), 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 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 regarding the request that manufacturers and distributors of all devices cleared by FDA for home use voluntarily submit final product labeling and information electronically as a part of a pilot program to be conducted by FDA's Center for Devices and Radiological Health (CDRH). FDA is requesting that manufacturers and distributors for these products submit final product labeling and information in a standard Structured Product Labeling (SPL) format that we intend to eventually place on a home use device product portal that will be accessible to the public.

The Food and Drug Administration (FDA) is extending for 60 days the comment period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register of March 19, 2010. In the ANPRM, FDA requested comments, data, research, or other information on the regulation of outdoor advertising of cigarettes and smokeless tobacco. The agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.