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

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.

This notice provides information about the Research Data Center (RDC) operated by the National Center for Health Statistics (NCHS) within the Centers for Disease Control and Prevention (CDC). The Research Data Center was established in 1998 to provide a mechanism whereby researchers can access detailed data files in a secure environment, without jeopardizing the confidentiality of respondents. Historically, the data files accessed in the RDC have consisted of NCHS survey data and vital statistics. RDC has recently begun accepting data files that were not produced from NCHS survey data. In order to assure that all data files are processed in a consistent manner, the original guidelines for accessing files in the RDC are being reviewed and revised as necessary. As part of the revision process, potential users are being given the opportunity to provide input on how the procedures of the RDC can best serve their research needs. This notice describes how to submit proposals requesting use of the data, mechanisms to access the RDC, requirements, use of outside data sets, costs for using the RDC, and other pertinent topics. We are seeking comments on these procedures and will post the final procedures on the NCHS Web site.

The Personal Responsibility and Work Opportunity Reconciliation Act of 1996 (PRWORA) created and expanded State and Federal Child Support Enforcement databases under title IV-D of the Social Security Act and significantly enhanced access to information for title IV-D child support purposes. States are moving toward more integrated service delivery to better serve the families and further the mission of the child support enforcement program, while protecting confidential data. This Notice of Proposed Rulemaking (NPRM) proposes requirements for: State Parent Locator Service responses to authorized location requests; and State Child Support Enforcement program safeguards for confidential information and authorized disclosures of this information. This proposed rule would revise certain aspects of the final rule State Parent Locator Service; Safeguarding Child Support Information Final Rule published on September 26, 2008 and effective December 30, 2010. This NPRM will prohibit disclosure of confidential and personally identifiable information to private collection agencies and expand disclosure to child welfare programs and the Supplemental Nutrition Assistance Program (SNAP).

Notice of a discussion of a proposed action under Section III- A-1 published on May 24, 2010 (75 FR 28811) is withdrawn. The discussion that was to be held at the June 16-17, 2010 meeting of the NIH Recombinant DNA Advisory Committee has been deferred at the request of the principal investigator.

The Food and Drug Administration (FDA) is seeking participants for a voluntary pilot program whereby persons submit to FDA notices of claims that a particular use of a substance in food for animals is exempt from the statutory premarket approval requirements based on the notifier's determination that such use is generally recognized as safe (GRAS). FDA intends to evaluate these notices and will inform each participant (notifier) in writing either that the notice provides a sufficient basis for the GRAS determination or that FDA has identified questions as to whether the intended use of the substance is GRAS.

The Food and Drug Administration (FDA) is announcing the availability of an information sheet guidance entitled, ``Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs; Frequently Asked QuestionsStatement of Investigator (Form FDA 1572).'' This guidance is intended to assist sponsors, clinical investigators, and institutional review boards (IRBs) involved in clinical investigations of investigational drugs and biologics in completing the Statement of Investigator form (Form FDA 1572). FDA developed this information sheet guidance in response to numerous questions from the research community regarding Form FDA 1572. This information sheet guidance provides FDA's responses to the most frequently asked questions.

The Bureau of Indian Affairs (BIA) in the Department of the Interior (DOI) and the Indian Health Service (IHS) in the Department of Health and Human Services (HHS) are making limited technical amendments to their joint regulations governing contracts and annual funding agreements under the Indian Self-Determination and Education Assistance Act to update the appeals procedures.

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 unemployment compensation (UC) programs.

In accordance with the requirements of the Privacy Act of 1974, the U.S. Department of Health & Human Services (HHS) is proposing to establish a new system of records (SOR) titled ``Early Retirement Reinsurance Program (ERRP),'' System No. 09-90-0250. Under authority of Section 1102 of the Patient Protection and Affordable Care Act (the Affordable Care Act) (Pub. L. 111-148) the Early Retiree Reinsurance Program is established. The program provides reimbursement to participating employment-based plans for a portion of the cost of health benefits for early retirees and their spouses, surviving spouses and dependents. The system will collect and maintain information on individuals associated with plan sponsors who perform key tasks on behalf of the sponsor in order for the sponsor to participate in and receive reimbursement under the program. The system will also collect and maintain information on early retirees, and their spouses, etc., so that sponsors' eligibility to receive reimbursement for the claims of such specific individuals can be verified. The system will also collect and maintain information related to the documentation of actual medical costs of claims for health benefits submitted to the Department, to ensure accurate reimbursement under the program.

The Office of the Secretary is accepting resumes or curricula vitae from qualified individuals who wish to be considered for membership on the National Biodefense Science Board. Six members have membership expiration dates of December 31, 2010. Nominees are being accepted in the following categories: industry; academia, health care consumers, and from State and local governments and public health agencies, emergency responders and organizations representing other appropriate stakeholders. Submit a resume or curriculum vitae to nbsb@hhs.gov by June 30, 2010.

The Health Resources and Services Administration (HRSA) is requesting nominations to fill three vacancies on the Advisory Commission on Childhood Vaccines (ACCV). The ACCV was established by Title XXI of the Public Health Service Act (the Act), as enacted by Public Law (Pub. L.) 99-660 and as subsequently amended, advises the Secretary of Health and Human Services (the Secretary) on issues related to implementation of the National Vaccine Injury Compensation Program (VICP).