Department of Health and Human Services March 15, 2011 – Federal Register Recent Federal Regulation Documents
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Proposed Collection; Comment Request; A Generic Submission for Formative Research, Pretesting, Stakeholder Measures and Advocate Forms at NCI
Under the provisions of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: A Generic Submission for Formative Research, Pre-testing, Stakeholder Measures and Advocate Forms at NCI. Type of Information Collection Request: New. Need and Use of Information Collection: In order to carry out NCI's legislative mandate, the Office of Advocacy Relations (OAR) disseminates cancer- related information to a variety of stakeholders, seeks their input and feedback, and facilitates collaboration between the Institute and these external partners to advance NCI's authorized programs. It is beneficial for NCI, through the OAR, to pretest strategies, concepts, activities and materials while they are under development. Additionally, administrative forms may be part of this generic submission since they are a necessary part of collecting demographic information and areas of interest for advocates. Pre-testing, or formative evaluation, helps ensure that the products and services developed by NCI have the greatest capacity of being received, understood, and accepted by their target audiences. Since OAR is responsible for matching advocates to NCI programs and initiatives across the cancer continuum, it is necessary to measure the satisfaction of both internal and external stakeholders with this collaboration. This customer satisfaction research helps ensure the relevance, utility, and appropriateness of the many initiatives and products that OAR and NCI produce. The OAR will use a variety of qualitative (focus groups, interviews) and quantitative (paper, phone, in-person, and web surveys) methodologies to conduct this research, allowing NCI to: (1) Understand characteristics (attitudes, beliefs, and behaviors) of the intended target audience and use this information in the development of effective strategies, concepts, activities; (2) use a feedback loop to help refine, revise, and enhance OAR's efforts ensuring that they have the greatest relevance, utility, appropriateness, and impact for/to target audiences; and (3) expend limited program resource dollars wisely and effectively. Frequency of Response: On occasion. Affected Public: Individuals or households; Businesses or other for profit; Not-for-profit institutions and organizations; Federal Government; State, Local, or Tribal Government. Type of Respondents: Adult cancer research advocates; members of the public; health care professionals; organizational representatives. Table 1 outlines the estimated burden hours required for a three-year approval of this generic submission. There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Proposed Collection; Comment Request; NCI Cancer Genetics Services Directory Web-Based Application Form and Update Mailer
In compliance with the requirement of Section 3506(c)(2)(A) of the Paperwork Reduction Act of 1995, for opportunity for public comment on proposed data collection projects, the National Cancer Institute (NCI), the National Institutes of Health (NIH) will publish periodic summaries of proposed projects to be submitted to the Office of Management and Budget (OMB) for review and approval. Proposed Collection: Title: NCI Cancer Genetics Services Directory Web-based Application Form and Update Mailer. Type of Information Collection Request: Existing Collection in Use Without an OMB Number. Need and Use of Information Collection: The purpose of the online application form and the Web-based update mailer is to collect information about genetics professionals to be included in the NCI Cancer Genetics Services Directory on NCI's Cancer.gov Web site. The information collected includes name, practice locations, professional qualifications, and areas of specialization. Frequency of Response: Information is collected once via the online application form, and then updated annually via the Web-based mailer. Affected Public: Individuals. Type of Respondents: Genetics professionals including nurses, physicians, genetic counselors, and other professionals who provide services related to cancer genetics. The annual reporting burden is estimated at 180 hours (see Table below). There are no Capital Costs, Operating Costs, and/or Maintenance Costs to report.
Guidance for Industry on Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products.'' The guidance encourages manufacturers of medically necessary drug products (MNPs) and components to develop production plans in the event of an emergency that results in high absenteeism at one or more production facilities. The purpose of the guidance is to provide to industry considerations for developing plans for these types of emergencies, as well as to discuss the Center for Drug Evaluation and Research's (CDER's) intended approach to assist in avoiding drug product shortages that may have a negative impact on the national public health during such emergencies.
Draft Guidance for Industry on Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework.'' This guidance describes the importance of implementing appropriate steps during the manufacturing process to prevent cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients (APIs) with non- penicillin beta-lactam antibiotics. The draft guidance is intended to assist manufacturers in assessing whether separate facilities should be used based on the relative health risk of cross-reactivity.
Determination that ROCEPHIN (Ceftriaxone Sodium) Injection, 250 Milligrams, 500 Milligrams, 1 Gram, 2 Grams, and 10 Grams Base/Vial, Approved Under New Drug Application 050585, Were Not Withdrawn From Sale for Reasons of Safety or Effectiveness
The Food and Drug Administration (FDA) has determined ROCEPHIN (ceftriaxone sodium) Injection, 250 milligrams (mg), 500mg, 1 gram (g), 2g, and 10g base/vial, approved under new drug application (NDA) 050585, were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for any of these products if all other legal and regulatory requirements are met.
Investigational New Drug Applications and Abbreviated New Drug Applications; Technical Amendment
The Food and Drug Administration (FDA) is amending its investigational new drug application (IND) regulations and abbreviated new drug application regulations to correct inaccurate cross-references to the IND regulations and the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This action is being taken to ensure accuracy and clarity in the Agency's regulations.
Guidance for Industry on Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims; Availability
The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled ``Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims.'' This guidance is intended to assist applicants in developing labeling for outcome claims for drugs that are indicated to treat hypertension. With few exceptions, current labeling for antihypertensive drugs includes only the information that these drugs are indicated to reduce blood pressure; the labeling does not include information on the clinical benefits related to cardiovascular outcomes expected from such blood pressure reduction. However, blood pressure control is well established as beneficial in preventing serious cardiovascular events, and inadequate treatment of hypertension is acknowledged as a significant public health problem. The Agency believes that the appropriate use of these drugs can be encouraged by making the connection between lower blood pressure and improved cardiovascular outcomes more explicit in labeling.
Extension of Memorandum of Understanding Between the Food and Drug Administration and Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria of the United Mexican States Concerning Entry of Mexican Cantaloupes Into the United States of America
The Food and Drug Administration (FDA) is providing notice of an extension of memorandum of understanding (MOU) between FDA and Servicio Nacional de Sanidad, Inocuidad y Calidad Agroalimentaria of the United Mexican States. The purpose of the MOU is to establish, and build confidence in, a system that increases the likelihood that cantaloupes from Mexico offered for import into the United States comply with U.S. law. This MOU also establishes a risk-based classification system for firms in Mexico producing cantaloupes for import into the United States to protect the public health.
Generic Drug User Fee; Notice of Public Meeting; Reopening of the Comment Period
The Food and Drug Administration (FDA) is reopening until June 30, 2011, the comment period for the notice of public meeting, published in the Federal Register of August 9, 2010 (75 FR 47820), entitled ``Generic Drug User Fee; Public Meeting; Request for Comments.'' In that notice, FDA announced a public meeting that took place on September 17, 2010, to gather stakeholder input on the development of a generic drug user fee program. FDA is reopening the comment period for the expected duration of the active negotiation phase to ensure that all interested stakeholders have the opportunity to share their views on the matter.
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Medical Devices; Reports of Corrections and Removals
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.
Call for Comments on the Draft Report of the Adult Immunization Working Group to the National Vaccine Advisory Committee on Adult Immunization: Complex Challenges and Recommendations for Improvement; Correction
The Department of Health and Human Services published a notice in the Federal Register of March 4, 2011, announcing a call for comment on the draft report of the Adult Immunization Working Group to the National Vaccine Advisory Committee. It was announced that the draft report and recommendations could be found on the Web at https:// www.hhs.gov/nvpo/nvac/subgroups/adultimmunization. The Web address where the draft report and recommendations can be found is https:// www.hhs.gov/nvpo/nvac/subgroups/adultimmunization.html.
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