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

The Food and Drug Administration (FDA) is announcing its determination that ACCUTANE (isotretinoin) Capsules, 10 milligrams (mg), 20 mg, and 40 mg, were not withdrawn from sale for reasons of safety or effectiveness. This determination means that FDA will not begin procedures to withdraw approval of abbreviated new drug applications (ANDAs) that refer to these drug products, and it will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.

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).

This notice announces that the Administration for Children and Families (ACF), Administration for Native Americans (ANA) has awarded five single-source urgent grants to fund projects that are designed to mitigate the impact of the devastation caused by the tsunami that seriously damaged American Samoa on September 29, 2009. As a result of the devastating tsunami, 32 people were killed and 277 homes, schools, businesses, and transportation systems were destroyed. The event left the people of American Samoa traumatized and in need of assistance to re-start their lives. ACF/ANA is providing urgent financial assistance to four non-profit organizations and one local government agency to

This document corrects technical errors that appeared in the final rule with comment period published in the Federal Register on May 28, 2010 entitled ``Medicaid Program; Premiums and Cost Sharing.'' The May 28, 2010, final rule revised a November 25, 2008, final rule entitled, ``Medicaid Programs; Premiums and Cost Sharing'' which

In accordance with the requirements of the Privacy Act of 1974, the U.S. Department of Health and Human Services' (HHS) Office of Consumer Information and Insurance Oversight (OCIIO) is proposing to establish a new system of records (SOR) titled ``Pre-Existing Condition Insurance Plan (PCIP),'' System No. 09-90-0275. Section 1101 of Title I of the Patient Protection and Affordable Care Act of 2010 (Affordable Care Act) requires that the Secretary of Health and Human Services establish, either directly or through contracts with States and nonprofit private entities, a temporary high risk health insurance pool program to make health insurance coverage available at standard rates to uninsured individuals with pre-existing conditions. This program will continue until January 1, 2014, when American Health Benefit Exchanges established under sections 1311 and 1321 of the Affordable Care Act will be available for individuals to obtain health insurance coverage. HHS provided each State or its designated nonprofit entity the opportunity to contract with HHS to establish this program. However, to the extent that HHS does contract with a State to administer the program, HHS will make available a Pre-Existing Insurance Plan in such State under arrangements with the U.S. Office of Personnel Management, the U.S. Department of Agriculture's National Finance Center (NFC), and one or more nonprofit entities to serve as a third-party administrator (TPA) responsible for maintaining a network of health care providers and adjudicating claims for covered services.

The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved. This list is intended to inform the public of the availability of safety and effectiveness summaries of approved PMAs through the Internet and the agency's Division of Dockets Management.

The National Institute of Environmental Health Sciences (NIEHS), a research institute of the National Institutes of Health (NIH) within the Department of Health and Human Services (DHHS), is seeking comments on this draft National Institute of Environmental Health Sciences Superfund Hazardous Substance Research and Training Program (SRP) Strategic Plan.

HRSA believes that community input is valuable to the development of policies and policy documents related to the implementation of HRSA programs, including the Health Center Program. Therefore, we are requesting comments on the FTCA Policy Manual referenced above. Comments will be reviewed and analyzed, and a summary and general response to comments will be published as soon as possible after the comment submission deadline.

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: ``National Hospital Adverse Event Reporting System: Questionnaire Redesign and Testing.'' 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 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: ``Assessing the Impact of the National Implementation of TeamSTEPPS Master Training Program.'' In accordance with the Paperwork Reduction Act, 44 U.S.C. 3501-3520, AHRQ invites the public to comment on this proposed information collection.