Department of Health and Human Services September 30, 2010 – Federal Register Recent Federal Regulation Documents
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Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Petition to Request an Exemption From 100 Percent Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements
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.
National Committee on Vital and Health Statistics; Nominations
The purpose of this notice is to solicit nominations for membership on the National Committee on Vital and Health Statistics (NCVHS). The NCVHS is the statutory public advisory body to the U.S. Department of Health and Human Services (HHS) in the areas of health data policy, data standards, health information privacy, population- based data and HIPAA Administrative Simplification. The Committee has also been assigned additional advisory responsibilities in health data standards and health information privacy as a result of the Administrative Simplification Compliance Act, the Medicare Modernization Act and the Affordable Care Act. Several vacancies are expected to occur on the Committee as of December 2010. Accordingly, the Secretary of Health and Human Services will appoint new members of the Committee to terms of up to four years from among persons who have distinguished themselves in the following fields: Health statistics, electronic interchange of health care information, privacy and security of electronic information, population-based public health, purchasing or financing health care services, integrated computerized health information systems, health services research, consumer interests in health information, health data standards, epidemiology, and the provision of health services. In appointing members, the Department will give close attention to equitable geographic distribution and to minority and female representation. Appointments will be made without discrimination on the basis of age, race, gender, sexual orientation, HIV status, cultural, religious or socioeconomic status.
Privacy Act of 1974; Report of an Altered System of Records
In accordance with the requirements of the Privacy Act of 1974, the Health Resources and Services Administration (HRSA) is proposing to alter the system of records for the National Vaccine Injury Compensation Program, 09-15-0056. In accordance with the National Childhood Vaccine Injury Act of 1986, as amended (42 U.S.C. 300aa-10, et seq.) (the Vaccine Act), the National Vaccine Injury Compensation Program receives records from individuals or representatives of individuals alleged to be injured by vaccines. The purposes of these alterations are to update the system name, authority, and location; make a minor change to the purposes, add new routine uses (numbers 10, 11, 12, 13, and 14); update the safeguards; update retention and disposal; and update the system manager contact information.
Implantation or Injectable Dosage Form New Animal Drugs; Dexmedetomidine
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental new animal drug application (NADA) filed by Orion Corp. The supplemental NADA provides for veterinary prescription use of dexmedetomidine hydrochloride injectable solution as a preanesthetic to general anesthesia in cats.
New Animal Drugs for Use in Animal Feeds; Melengestrol
The Food and Drug Administration (FDA) is amending the animal drug regulations to more accurately reflect the recent approval of two supplemental new animal drug applications (NADAs) filed by Pharmacia & Upjohn Co., a Division of Pfizer, Inc. The supplemental NADAs provided for increased levels of monensin in two-way Type C medicated feeds containing melengestrol acetate and monensin, and in three-way Type C medicated feeds containing melengestrol acetate, monensin, and tylosin phosphate for heifers fed in confinement for slaughter. These amendments are being made to improve the accuracy of the regulations.
Agency Information Collection Activities: Proposed Collection; Comment Request
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: ``Reduction of Clostridium difficile Infections in a Regional Collaborative of Inpatient Healthcare Settings through Implementation of Antimicrobial Stewardship.'' 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 proposed information collection was previously published in the Federal Register on July 23, 2010 and allowed 60 days for public comment. No comments were received. The purpose of this notice is to allow an additional 30 days for public comment.
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