Draft Guidance for Industry and Food and Drug Administration Staff; Glass Syringes for Delivering Drug and Biological Products: Technical Information To Supplement International Organization for Standardization Standard 11040-4; Availability
The Food and Drug Administration (FDA) is announcing the availability of draft guidance for industry and FDA staff entitled ``Glass Syringes for Delivering Drug and Biological Products: Technical Information to Supplement International Organization for Standardization (ISO) Standard 11040-4.'' These supplemental data are necessary for FDA to ensure the safe and effective use of glass syringes that comply with the ISO 11040-4 standard when connected to devices (``connecting devices'') that comply with the ISO 594-2 standard.
Agency Information Collection Activities: Proposed Collection: Comment Request
In compliance with the requirement for opportunity for public comment on proposed data collection projects (Section 3506(c)(2)(A) of Title 44, United States Code, as amended by the Paperwork Reduction Act of 1995, Pub. L. 104-13), the Health Resources and Services Administration (HRSA) publishes periodic summaries of proposed projects being developed for submission to the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995. To request more information on the proposed project or to obtain a copy of the data collection plans and draft instruments, email firstname.lastname@example.org or call the HRSA Reports Clearance Officer at (301) 443-1984. HRSA especially requests comments on: (1) The necessity and utility of the proposed information collection for the proper performance of the agency's functions, (2) the accuracy of the estimated burden, (3) ways to enhance the quality, utility, and clarity of the information to be collected, and (4) the use of automated collection techniques or other forms of information technology to minimize the information collection burden. Information Collection Request Title: Primary Care Faculty Development Initiative (OMB No. 0915-xxxx)[New]. Abstract: HRSA's Bureau of Health Professions, Division of Medicine and Dentistry, has contracted with Oregon Health and Science University (OHSU), contract HHSH250201200023C, to conduct the planning, execution, and evaluation of a nationally based, longitudinal Primary Care Faculty Development Initiative (PCFDI) demonstration project. OHSU has developed web-based survey instruments which will be used to evaluate the effectiveness of the planned curriculum and its implementation and to make recommendations to improve teaching and competency assessment in primary care educational activities. The two web-based surveys are Irvine's Leadership Behavior Survey and the Faculty Skill & Program Feasibility Survey. The objectives of the survey instruments are to: assess the feasibility and acceptability of an inter-disciplinary faculty development pilot program targeting primary care physicians; to measure the leadership skills of PCFDI faculty participants; and to assess the initial impact of faculty receiving training from an inter-disciplinary faculty development pilot program on their perception of skill development in the core content areas of leadership, change management, teamwork, panel or population management, competency assessment, and clinical microsystems. Burden Statement: Burden in this context means the time expended by persons to generate, maintain, retain, disclose or provide the information requested. This includes the time needed to review instructions, to develop, acquire, install and utilize technology and systems for the purpose of collecting, validating and verifying information, processing and maintaining information, and disclosing and providing information, to train personnel and to be able to respond to a collection of information, to search data sources, to complete and review the collection of information, and to transmit or otherwise disclose the information. The total annual burden hours estimated for this Information Collection Request are summarized in the table below. The annual estimate of burden is as follows:
New Animal Drugs; Enrofloxacin; Tilmicosin; Tylosin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval actions for new animal drug applications and abbreviated new animal drug applications during February 2013. FDA is also informing the public of the availability of summaries the basis of approval and of environmental review documents, where applicable.