Department of Health and Human Services February 2011 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) is extending the comment period for a proposed recommendation that community water systems adjust the amount of fluoride in drinking water to 0.7 mg/L to provide the best of balance of protection from dental caries while limiting the risk of dental fluorosis. The proposed recommendation was published in the Federal Register on January 13, 2011, Volume 76, Number 9, page 2383.

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 W.R. Grace and Company in Curtis, Maryland, 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: W.R. Grace and Company. Location: Curtis, Maryland. Job Titles and/or Job Duties: All Atomic Weapons Employer employees. Period of Employment: Operational period from January 1, 1955 through December 31, 1958, and the residual radiation period from January 1, 1959 through October 31, 2009.

The Patient Safety and Quality Improvement Act of 2005, 42 U.S.C. 299b-21 to b-26, (Patient Safety Act), and its implementing regulation at 42 CFR part 3, provides for the formation of Patient Safety Organizations (PSO5), which collect, aggregate, and analyze confidential information regarding the quality and safety of healthcare delivery. On December 30, 2010, HHS issued ``Guidance Regarding Patient Safety Organizations' Reporting Obligations and the Patient Safety and Quality Improvement Act of 2005'' (Guidance) which can be accessed electronically at: https://www.PSO.AHRQ.gov/regulations/guidance.pdf. This notice announces the intention of AHRQ to request that the Office of Management and Budget (OMB) amend the approved clearance, OMB No. 0935-0143, that allows information collection related to implementation of the Patient Safety Act. This amendment includes a new attestation form related to the Guidance. In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3521, AHRQ invites the public to comment on this proposed information collection. The purpose of this notice is to allow 30 days for public comment on the new attestation form related to the Guidance.

The Federally Supported Health Centers Assistance Act of 1992, as amended in 1995 (FSHCAA), provides for liability protection for certain grantees of the Public Health Service and for certain individuals associated with these grantees. The Health Resources and Services Administration (HRSA) is the operating division within the Department responsible for administering certain aspects of FSHCAA. HRSA proposes replacing the current regulations with the key text and examples of activities that have been determined, consistent with provisions of the existing regulation, to be covered by the FTCA, as previously published in the Sept. 25, 1995 Federal Register. In addition, HRSA proposes adding an example of services covered under the FTCA involving individual emergency care provided to a non-health center patient and updating the September 1995 Notice immunization example to include events to immunize individuals against infectious illnesses. When finalized, the amended regulation will supersede the September 1995 Notice.

This notice announces our decision to approve the Joint Commission for recognition as a national accreditation program for psychiatric hospitals seeking to participate in the Medicare or Medicaid programs. This initial 4-year approval is effective February 25, 2011, through February 25, 2015.

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 notice announces the dates, time, and location of the Healthcare Common Procedure Coding System (HCPCS) public meetings to be held in calendar year 2011 to discuss our preliminary coding and payment determinations for all new public requests for revisions to the HCPCS. These meetings provide a forum for interested parties to make oral presentations or to submit written comments in response to preliminary coding and payment determinations. The discussion will be focused on responses to our specific preliminary recommendations and will include all items on the public meeting agenda.

The National Institutes of Health (NIH) requests public comments on (1) NIH's adoption of the eighth edition of the Guide for the Care and Use of Laboratory Animals (Guide) as a basis for evaluation of institutional programs receiving or proposing to receive Public Health Service (PHS) support for activities involving animals; and (2) if NIH decides to adopt the eighth edition of the Guide, NIH's proposed implementation plan, which would require that institutions complete at least one semiannual program and facility evaluation using the eighth edition of the Guide as the basis for evaluation by March 31, 2012. NIH will consider comments on (1) the adoption of the Guide and (2) the implementation plan.

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.