Department of Health and Human Services 2007 – Federal Register Recent Federal Regulation Documents

The Department of Health and Human Services (HHS) gives notice concerning the final effect of the HHS decision to designate a class of employees at the Rocky Flats Plant, Golden, Colorado, as an addition to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000. On August 6, 2007, 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:

The Department of Health and Human Services (HHS) gives notice as required by 42 CFR 83.12(e) of a decision to evaluate a petition to designate a class of employees at the Y-12 facility, Oak Ridge, Tennessee, 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: Y-12. Location: Oak Ridge, Tennessee. Job Titles and/or Job Duties: All workers. Period of Employment: March 1, 1943 through December 31, 1947.

HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of BPHC programs, including the FQHC Look-Alike Program. Therefore, we are requesting comments on the PIN referenced above. After review and consideration of all comments received, the PIN may be amended to incorporate certain recommendations from the public. Once the PIN is finalized, it will be made available on HRSA's Web site, along with the Agency's ``Response to Public Comments.'' That document will summarize the major comments received and describe the Agency's response, including any corresponding changes made to the PIN. Where comments do not result in a revision to the PIN, explanations will be provided. Background: HRSA has received numerous requests for clarification regarding the program guidelines, requirements, and application process for the FQHC Look-Alike program. The purpose of the FQHC Look-Alike PIN is to respond to these requests for clarification and to make the application process more consistent with section 330 grant programs. The Omnibus Budget Reconciliation Acts of 1989, 1990, and 1993 amended section 1905 of the Social Security Act to create a new category of facility under Medicaid and Medicare known as Federally Qualified Health Centers (FQHCs). The Social Security Act Sec. 1905(l)(2)(B) definition of an FQHC included an entity which, based on the recommendation of HRSA, is determined to meet the requirements of the section 330 grant program but does not receive the grant. This category of health centers has been labeled FQHC Look-Alikes. To ensure that there are appropriate numbers of health centers to serve the millions of uninsured and underinsured populations throughout the country, FQHC Look-Alike status was made available to those entities that do not receive funding under section 330 but operate and provide services similar to grant-funded programs. As such, FQHC Look- Alikes are expected to demonstrate a commitment to serve all populations residing in their respective medically underserved communities regardless of their ability to pay and to satisfy all of the administrative, management, governance and service-related requirements that apply to section 330 funded health centers. Benefits of obtaining FQHC Look-Alike status include eligibility for enhanced Medicaid and Medicare reimbursement, participation in the 340(b) Federal Drug Pricing Program, and automatic Health Professional Shortage Area designation. HRSA is responsible for managing the FQHC Look-Alike program and submitting recommendations to the Centers for Medicare and Medicaid Services (CMS) for designation as FQHCs; however, CMS has the final authority to designate applicants as FQHCs. The organizations are recertified annually to assure they are in compliance with these regulations.

Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the Office of the Director (OD), Office of Extramural Research (OER) Office of Extramural Programs (OEP), 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 February 15, 2007, pages 7442-7443 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 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.

The Food and Drug Administration (FDA) is announcing that a collection of information entitled ``Human Tissue Intended for Transplantation'' 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 announcing the availability of a guidance for industry (178) entitled ``Recommended Study Design and Evaluation of Effectiveness Studies for Swine Respiratory Disease Claims.'' This guidance provides recommendations to industry relating to study design and describes the criteria that the Center for Veterinary Medicine (CVM) intends to use to evaluate effectiveness studies for swine respiratory disease (SRD) claims.

The Food and Drug Administration (FDA) is announcing its intention to take enforcement action, as described in this notice, against unapproved drug products containing hydrocodone bitartrate, or any other salt or ester of hydrocodone (hereinafter collectively ``hydrocodone''), and persons who manufacture or cause the manufacture of such products or their shipment in interstate commerce. Unapproved hydrocodone products have been implicated in reports of medication errors, including improper dosing and dispensing the wrong drug. Some of these products omit important labeling warnings and information or are inappropriately labeled for use in young children. Drug products containing hydrocodone are new drugs that require approved applications because they are not generally recognized as safe and effective. Manufacturers who wish to market a drug product containing hydrocodone must obtain FDA approval of a new drug application (NDA) or an abbreviated new drug application (ANDA).

This document corrects typographical errors that appeared in the final rule published in the August 31, 2007 Federal Register entitled ``Medicare Program; Hospice Wage Index for Fiscal Year 2008.''