Department of Health and Human Services October 2009 – Federal Register Recent Federal Regulation Documents
Results 51 - 100 of 343
Agency Information Collection Activities; Proposed Collection; Comment Request; Antimicrobial Animal Drug Distribution Reports Under Section 105 of the Animal Drug User Fee Amendments of 2008
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 and including each proposed extension of a collection of information and to allow 60 days for public comment in response to the notice. This notice solicits comments on reporting and recordkeeping requirements for antimicrobial animal drug distribution as required by Section 105 of the Animal Drug User Fee Amendments of 2008 (ADUFA).
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: change the security classification of the system from low to moderate; add an additional system location, to reflect the creation of a system contingency site; delete language from authorized users of the system; add information on physical safeguards pertaining to system security; delete the use of a receptionist controlled area from the physical safeguards for the system; change the room number for the system manager; change the legal authority cited for maintenance of system information; add a new routine use to Information Center (IC) Integrated Clearinghouse System (ICS), 09-15-0067, last published at 72 Federal Register 44846-44847 (August 9, 2007). The HRSA Office of Communications is responsible for the HRSA IC/ICS System of Records (SOR), which is an existing Agency SOR.
Guidance for Industry on Investigator Responsibilities-Protecting the Rights, Safety, and Welfare of Study Subjects; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Investigator ResponsibilitiesProtecting the Rights, Safety, and Welfare of Study Subjects.'' This guidance is intended to assist investigators in meeting their responsibilities with respect to protecting human subjects and ensuring the integrity of data in the conduct of clinical investigations. The guidance also clarifies FDA's expectations concerning the investigator's responsibility for supervising a clinical study in which some study tasks are delegated to employees of the investigator or to outside parties.
Agency Information Collection Activities; Proposed Collection; Comment Request; Tobacco Product Standard for Flavored Cigarettes
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 proposed extension of an existing collection of information pertaining to the tobacco product standard for flavored cigarettes under the Family Smoking Prevention and Tobacco Control Act (FSPTCA).
National Toxicology Program (NTP); Office of Liaison, Policy and Review; Meeting of the NTP Board of Scientific Counselors
Pursuant to Public Law 92-463, notice is hereby given of a meeting of the NTP Board of Scientific Counselors (BSC). The BSC is a Federally chartered, external advisory group composed of scientists from the public and private sectors that provides primary scientific oversight to the NTP Director and evaluates the scientific merit of the NTP's intramural and collaborative programs.
Medicare Program; Criteria for Medicare Coverage of Inpatient Hospital Rehabilitation Services
This notice rescinds HCFA Ruling 85-2, ``Medicare Criteria for Coverage of Inpatient Hospital Rehabilitation Services,'' 50 FR 31040 (July 31, 1985), as corrected at 50 FR 32643 (Aug. 13, 1985) which established the criteria for Medicare coverage of inpatient hospital rehabilitation services.
Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational Device Exemptions Reports and Records
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 Investigational Device Exemptions Reports and Records.
Agency Information Collection Activities; Proposed Collection; Comment Request; Guidance for Industry, FDA, and Foreign Governments: Fiscal Year 2010 Medical Device User Fee Small Business Qualification and Certification
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 FDA Forms 3602 and FDA Form 3602A which will allow domestic and foreign applicants to certify that they qualify as a ``small business'' and pay certain medical device user fees at reduced rates.
Agency Information Collection Activities; Proposed Collection; Comment Request; Recordkeeping and Reporting Requirements for Human Food and Cosmetics Manufactured From, Processed With, or Otherwise Containing, Material From Cattle
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 information collection requirements of FDA's regulations that require records on FDA-regulated human food, including dietary supplements, and cosmetics that are manufactured from, processed with, or otherwise contain, material derived from cattle.
New Animal Drug Applications
The Food and Drug Administration (FDA) is proposing to amend the regulations regarding new animal drug applications (NADAs). Specifically, this proposed rule is being issued to provide that NADAs shall be submitted in the form and containing the information described, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly provide the appropriate flexibility
New Animal Drug Applications
The Food and Drug Administration (FDA) is amending the regulations regarding new animal drug applications (NADAs). Specifically, this direct final rule is being issued to provide that NADAs shall be submitted in the described form, as appropriate for the particular submission. Currently, the regulation requires that all NADAs contain the same informational sections and does not explicitly
Medicare and Medicaid Programs; Conditional Approval of the Community Health Accreditation Program for Continued Deeming Authority for Hospices
This notice announces our decision to conditionally approve, with a 180-day probationary period, the Community Health Accreditation Program's (CHAP's) request for continued recognition as a national accreditation program for hospices seeking to participate in the Medicare or Medicaid programs.
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