Department of Health and Human Services September 19, 2011 – Federal Register Recent Federal Regulation Documents
Results 1 - 21 of 21
Privacy Act of 1974; Report of a New System of Records
In accordance with the requirements of the Privacy Act of 1974, CMS is establishing a new system of records to support its shared savings programs, the first of which are the Medicare Shared Savings Program and Pioneer ACO Model (collectively referred to as the ACO program). The ACO program implements recent health care reform provisions of the Patient Protection and Affordable Care Act (PPACA), amending the Social Security Act (the Act). The system of records will contain personally identifiable information (PII) about certain individuals who participate in, or whose PII is used to determine eligibility of an Accountable Care Organization (ACO) to participate in, a shared savings program; i.e., Medicare fee-for-service (FFS) beneficiaries, sole proprietor health care ACO participants and ACO suppliers/providers, key leaders and managers of accountable care organizations (ACOs), and contact persons for ACOs. The program and the system of records are more thoroughly described in the Supplementary Information section and System of Records Notice (SORN), below.
Draft Guidance for Industry on Self-Selection Studies for Nonprescription Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Self-Selection Studies for Nonprescription Drug Products.'' The draft guidance is intended to provide recommendations to industry on the design of self- selection studies for nonprescription drug products. Self-selection studies are conducted to ensure that consumers are able to make the correct decision to use, or not use, a nonprescription drug product based on their personal medical situation.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Experimental Study: Effect of Promotional Offers in Direct-to-Consumer Prescription Drug Print Advertisements on Consumer Product Perceptions
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.
Prescription Drug User Fee Act IV Information Technology Plan
The Food and Drug Administration (FDA) is announcing the availability of an updated information technology (IT) plan entitled ``PDUFA IV Information Technology Plan'' (updated plan) to achieve the objectives defined in the Prescription Drug User Fee Act (PDUFA) Performance Goals. This plan is intended to provide regulated industry and other stakeholders with information on FDA's vision and plan for improving the automation of business processes and maintaining information systems that support the process for the review of human drug applications. The FDA is publishing the updated plan for comment to allow the public to provide feedback as the Agency moves towards a fully electronic standards-based submission and review environment.
Consumer Health IT Pledge Program
The U.S. Department of Health & Human Services' Office of the National Coordinator for Health Information Technology (ONC) is leading a national campaign to educate and engage the public on the value and benefits of health information technology (health IT) in improving health and health care. As part of the campaign, we encourage entities that touch Americans' lives to pledge to empower individuals to be partners in their health through health IT. There are two types of pledges: One for those who manage or maintain individually identifiable health data (e.g., providers, hospitals, payers, retail pharmacies) and another for those who do not manage or maintain consumer health data, but have the ability to educate consumers about the importance of getting access to and using their health information (e.g., employers, consumer and disease-based organizations, healthcare associations, product developers). Taking the pledge is voluntary, and does not represent any endorsement by the U.S. Department of Health and Human Services or any other part of the federal government. To learn more about the details of the pledge, please visit: http:/ /www.healthit.gov/pledge. Notice of this schedule is given under the American Recovery and Reinvestment Act of 2009 (Pub. L. 111-5), section 3003.
New Animal Drugs; Gamithromycin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an original new animal drug application (NADA) filed by Merial, Ltd. The NADA provides for the veterinary prescription use of gamithromycin injectable solution for the management of bovine respiratory disease (BRD). FDA is also amending the regulations to add the established tolerances for residues of gamithromycin in edible tissues of cattle.
Meeting of the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health
In accordance with Section 10(a) of the Federal Advisory Committee Act, Public Law 92-463, as amended (5 U.S.C. App.), notice is hereby given that a meeting is scheduled to be held for the Advisory Group on Prevention, Health Promotion, and Integrative and Public Health (the ``Advisory Group''). The meeting will be open to the public. Information about the Advisory Group can be obtained by accessing the following Web site: https://www.healthcare.gov/center/ councils/nphpphc/.
Tolerances for Residues of New Animal Drugs in Food; Progesterone
The Food and Drug Administration (FDA) is amending the animal drug regulations to update the allowable incremental increase for residues of progesterone in edible tissues of cattle and sheep based on the 1994 revised daily consumption values. This action is being taken to improve the accuracy of the regulations.
Implantation or Injectable Dosage Form New Animal Drugs; Ivermectin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of an abbreviated new animal drug application (ANADA) filed by Cross Vetpharm Group Ltd. The ANADA provides for use of an ivermectin injectable solution for treatment and control of various internal and external parasites in cattle, swine, reindeer, and American bison.
Meeting of the Secretary's Advisory Committee on Human Research Protections
Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary's Advisory Committee on Human Research Protections (SACHRP) will hold its twenty-sixth meeting. The meeting will be open to the public. Information about SACHRP and the meeting agenda will be posted on the SACHRP Web site at: https://www.dhhs.gov/ohrp/sachrp/mtgings/.
This site is protected by reCAPTCHA and the Google
Privacy Policy and
Terms of Service apply.
