Department of Health and Human Services January 16, 2008 – Federal Register Recent Federal Regulation Documents
Results 1 - 9 of 9
User Fee Program for Advisory Review of Direct-to-Consumer Television Advertisements for Prescription Drug and Biological Products; Program Will Not Be Implemented
The Food and Drug Administration (FDA) is issuing this notice to inform companies that the Direct-to-Consumer (DTC) television advertisement user fee program will not commence because the necessary user fees for the program were not ``provided in advance in appropriations Acts'' as required by the Food and Drug Administration Amendments Act of 2007 (FDAAA) and the previously issued notice establishing user fee rates for the program for fiscal year (FY) 2008 is being withdrawn.
Oral Dosage Form New Animal Drugs; Firocoxib Tablets
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 Merial Ltd. The supplemental NADA provides for veterinary prescription use of firocoxib chewable tablets in dogs for the control of postoperative pain and inflammation associated with soft-tissue surgery.
Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices
The Food and Drug Administration (FDA) is proposing to amend its regulations regarding changes to an approved new drug application (NDA), biologics license application (BLA), or medical device premarket approval application (PMA) to codify the agency's longstanding view on when a change to the labeling of an approved drug, biologic, or medical device may be made in advance of the agency's review of such change. FDA is proposing to reaffirm its longstanding position that a supplemental application submitted under those provisions is appropriate to amend the labeling for an approved product only to reflect newly acquired information, as well as to clarify that such a supplemental application may be used to add or strengthen a contraindication, warning, precaution, or adverse reaction only if there is sufficient evidence of a causal association with the drug, biologic, or device. The amendments proposed by this document are intended to reflect the agency's existing practices with respect to supplemental applications submitted to FDA.
Implantation or Injectable Dosage Form New Animal Drugs; Flunixin
The Food and Drug Administration (FDA) is amending the animal drug regulations to reflect approval of a supplemental abbreviated new animal drug application (ANADA) filed by Norbrook Laboratories, Ltd. The supplemental ANADA provides for the veterinary prescription use of flunixin meglumine solution by intravenous injection in lactating dairy cattle for control of pyrexia associated with acute bovine mastitis.
Animal Cloning Risk Assessment; Risk Management Plan; Guidance for Industry; Availability
The Food and Drug Administration (FDA) is announcing the availability of a risk assessment on animal cloning. FDA's Center for Veterinary Medicine (CVM) developed this risk assessment to evaluate the health risks to animals involved in the process of cloning and to evaluate the food consumption risks that may result from edible products derived from animal clones or their progeny. FDA is also announcing the availability of a risk management plan for animal clones and their progeny. The risk management plan takes into account the risks identified in the risk assessment and sets out measures that FDA will use to manage those risks. In addition, FDA is announcing availability of guidance for industry 179. This guidance describes FDA's recommendations regarding the use of edible products from animal clones and their progeny in human food or in animal feed.
National Institute of Child Health and Human Development; Longitudinal Investigation of Fertility and the Environment Study
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 Institute of Child Health and Human Development (NICHD), 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. This is a request for renewal of an information collection request that was approved (OMB Clearance 0925-0543) following publication in the Federal Register on January 9, 2004, page 1589 and December 2, 2004, page 70153. Proposed Collection: Title: Longitudinal Investigation of Fertility and the Environment Study. Type of Information Collection Request: Renewal of OMB Clearance 0925-0543. Need and Use of Information Collection: This study will assess the relation between select environmental factors and human fecundity and fertility. This research originally proposed to recruit 960 couples who are interested in becoming pregnant and willing to participate in a longitudinal study. Fewer than expected couples were enrolled during the first three years of the project (n=350), predominantly due to the fact that more couples were ineligible for participation than had been originally estimated. In light of this fact, the revised study plan is to enroll a total of 500 couples (i.e., 150 additional couples), a sample size that will not compromise the main study objectives. Fecundity will be measured by the time required for the couples to achieve pregnancy, while fertility will be measured by the ability of couples to have a live born infant. Couples who are unable to conceive within 12 months of trying or who experience a miscarriage also will be identified and considered to have fecundity-related impairments. The study's primary environmental exposures include: Organochlorine pesticides and polychlorinated biphenyls; metals; fluorinated compounds; phytoestrogens; and phthalates. A growing body of literature suggests these compounds may exert effects on human reproduction and development; however, definitive data are lacking serving as the impetus for this study. Couples will participate in a 20-30 minute baseline interview and be instructed in the use of home fertility monitors and pregnancy kits for counting the time required for pregnancy and detecting pregnancy. Blood and urine samples will be collected at baseline from both partners of the couple for measurement of the environmental exposures. Two semen samples from male partners and two saliva samples from female partners also will be requested. Semen samples will be used to assess male fecundity as measured primarily by sperm concentration and morphology. Saliva samples will be used for the measurement of cortisol levels as a marker of stress among female partners so that the relation between environmental factors, stress and human reproduction can be assessed. The findings will provide valuable information regarding the effect of environmental contaminants on sensitive markers of human reproduction and development, filling critical data gaps. Moreover, these environmental exposures will be analyzed in the context of other lifestyle exposures, consistent with the manner in which human beings are exposed. Frequency of Response: Following the baseline interview, couples will each complete a five-minute daily diary on select lifestyle factors. Women will perform daily fertility testing and pregnancy testing at day of expected menses using a dipstick test in urine. Each test will require approximately five minutes for completion. This testing and diary reporting is required only up to the time women become pregnant, which on average should be in 2-3 months. Men will provide two semen samples, a month apart, requiring approximately 20 minutes for each collection, and women will collect two saliva samples, a month apart, requiring approximately five minutes. Participating couples will be given a choice to submit their information by mail or to send it electronically to the Data Coordinating Center. This option will be available throughout data collection in the event couples change their minds about how they would like to submit information. Bio-specimens will be collected by study participants and research nurses, where appropriate, and forwarded in prepaid delivery packages to the study's laboratories. Affected Public: Individuals from participating communities. Type of Respondents: Men and women aged 18-40 years. Revised Estimated Number of Respondents: 1,000. Revised Estimated Number of Response Sets per Respondent: 6 per women and 3 per men over approximately two years. Average Burden Hours per Response: .1947 for women and .31975 for men. Revised Estimated Total Annual Burden Hours Requested: 1,658 for women and 889 for men. The revised burden estimates represent a 48 percent reduction in the originally requested burden. There is no cost to respondents. There are no Capital Costs to report. There are no Operating or Maintenance Costs to report. Request for Comments: Written comments and/or suggestions from the public and affected agencies are invited on one or more of the following points: (1) The necessity of the proposed collection of information for the proper performance of the function of the agency, including the practical utility of the information; (2) the accuracy of the agency's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used; (3) ways to enhance the quality, utility, and clarity of the information to be collected; and (4) ways to minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology.
Submission for OMB Review; Comment Request; Quality of Life Outcomes in Neurological Disorders
Under the provisions of Section 3507(a)(1)(D) of the Paperwork Reduction Act of 1995, the National Institute of Neurological Disorders and Stroke (NINDS), the National Institutes of Health (NIH) has submitted to the Office of Management and Budget (OMB) a request to review and approve the information collection listed below. This proposed information collection was previously published in the Federal Register on September 24, 2007, page number 54269 and allowed 60 days for public comment. One public comment was received; also received were one request for the data collection plans and proposed instruments and a request for information on a related Web site. The purpose of this notice is to allow an additional 30 days for public comment. The National Institutes of Health may not conduct or sponsor, and the respondent is not required to respond to, an information collection that has been extended, revised, or implemented on or after October 1, 1995, unless it displays a currently valid OMB control number. Proposed Collection: Title: Quality of Life Outcomes in Neurological Disorders; Type of Information Collection Request: New; Form Number: NA; Need and Use of Information Collection: In order to improve outcome measurement in clinical trials of neurological conditions, NINDS is developing a health-related quality of life (HRQL) measurement system for major neurological diseases that affect the United States population. This measurement system must be consistent enough across the selected conditions to allow for cross-disease comparison, and yet flexible enough to capture condition-specific HRQL issues. The primary end users of this measurement system will be clinical trialists and other clinical neurology researchers; however the measurement system will also be appropriate for clinical practice. The proposed information collection will support psychometric testing of HRQL item banks and testing of Spanish translation of the final questionnaires. Frequency of Response: Once; Affected Public: Individuals; Type of Respondent: Adults and children. The annual reporting burden is shown in the following table. There are no Capital Costs, Operating Costs or Maintenance Costs to report.
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