Department of Health and Human Services 2009 – Federal Register Recent Federal Regulation Documents

The Food and Drug Administration (FDA) is announcing that Kemira Oyj has filed a petition proposing that the food additive regulations be amended to provide for the safe use of formic acid as a pH control agent in swine feed.

The Regulatory Flexibility Act of 1980 and Executive Order (EO) 12866 requires the semi-annual issuance of an inventory of rulemaking actions under development throughout the Department with a view to offering summarized information about forthcoming regulatory actions for public review.

The Indian Health Service (IHS), as part of its continuing effort to reduce paperwork and respondent burden, conducts a preclearance consultation program to provide the general public and Federal agencies with an opportunity to comment on proposed and/or continuing collections of information in accordance with the Paperwork Reduction Act of 1995 (PRA95) (44 U.S.C. 3506(c)(2)(A)). This program helps to ensure that requested data can be provided in the desired format, reporting burden (time and financial resources) is minimized, collection instruments are clearly understood, and the impact of collection requirements on respondents can be properly assessed. Currently, the IHS is providing a 60-day advance opportunity for public comment on a proposed new collection of information to be submitted to the Office of Management and Budget for review.

The Food and Drug Administration (FDA) is announcing its determination that MESANTOIN (mephenytoin) Tablets, 100 milligrams (mg), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mephenytoin tablets, 100 mg, if all other legal and regulatory requirements are met.

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 extension 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 Manufactured Food Regulatory Program Standards.

HHS gives notice of a determination concerning a petition to add a class of employees at the Baker-Perkins Company, Saginaw, Michigan, to the Special Exposure Cohort (SEC) under the Energy Employees Occupational Illness Compensation Program Act of 2000 (EEOICPA), 42 U.S.C. 7384q. On November 13, 2009, the Secretary of HHS determined that the following class of employees does not meet the statutory criteria for addition to the SEC as authorized under EEOICPA:

Statement of Organization, Functions, and Delegations of Authority The Office of the National Coordinator for Health Information Technology has reorganized its substructure components in order to more effectively meet the mission outlined by The Health Information Technology for Economic and Clinical Health (HITECH) Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA). The reorganization affects all four of the original Director-level offices: the Office of Health Information Technology Adoption (OHITA); the Office of Interoperability and Standards (OIS); Office of Programs and Coordination (OPC); and the Office of Policy and Research (OPR). The new organizational structure is composed of five offices with direct reporting capability to the National Coordinator for Health Information Technology (National Coordinator): the Office of Economic Modeling and Analysis; the Office of the Chief Scientist; the Office of the Deputy National Coordinator for Programs & Policy; the Office of the Deputy National Coordinator for Operations, and the Office of the Chief Privacy Officer.

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 (PRA).

As stipulated by the Federal Advisory Committee Act, the Department of Health and Human Services (HHS) is hereby giving notice that the National Vaccine Advisory Committee (NVAC) will hold six teleconference meetings. The meetings are open to the public. Pre- registration is NOT required, however, individuals who wish to participate in the public comment sessions should either e-mail nvpo@hhs.gov or call 202-690-5566 to RSVP.