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1、Frequently Asked Questions (FAQs) about the Tobacco Products Scientific Advisory CommitteeThe purpose of the FAQs section is to provide the public with answers to common questions regarding the Tobacco Products Scientific Advisory Committee (TPSAC); including the nomination process for voting and no
2、n-voting industry members.1.Why did FDA create the TPSAC?The Family Smoking Prevention and Tobacco Control Act, passed by the United States Congress and signed by the President of the United States, calls for the creation of the TPSAC to provide advice, information, and recommendations to the Commis
3、sioner of Food and Drugs on health and other issues relating to tobacco products. 2.How often will the TPSAC meet each year?Meetings will be held approximately four times a year. 3.What is the date of the first TPSAC meeting?The date of the first meeting has not yet been set. However, the dates for
4、all meetings will be publicly announced in the Federal Register at least 15 days before the meeting as required by the Federal Advisory Committee Act. 4.What issues is the TPSAC required to discuss?The committee will be asked to consider a variety of topics, including: oIdentifying the effects of th
5、e alteration of the nicotine yields from tobacco products; oReporting on the impact of the use of menthol in cigarettes on the public health; and oAdvising on an application for modified risk (use of descriptors such as “light”) tobacco product. 5.Who will serve on the TPSAC?The TPSAC will consist o
6、f 12 members, including the Chair, who will be selected by the Commissioner of Food and Drugs from among experts knowledgeable in the fields of medicine, medical ethics, science, or technology involving the manufacture, evaluation, or use of tobacco products. 6.What is my role on a FDA advisory comm
7、ittee as a health care professional member (academician or practitioner)?An academician or a practitioner member uses his or her expert knowledge to provide state-of-the-art advice on scientific issues under deliberation at the FDA. These representatives publicly explore scientific questions that ha
8、ve regulatory impact.- 2-7.What is my role as a nonvoting industry representative on a FDA advisory committee?Almost without exception, FDAs advisory committees have industry representatives who act on behalf of regulated industry at committee meetings. The representative discusses an issue before t
9、he committee from the perspective of the affected industry and not as a representative of any individual organization. Representatives are non-voting members who usually serve a four- year term. Selection is achieved by a process conducted by a committee of peers. The nomination process is described
10、 in the Code of Federal Regulations (21 C.F.R. 14.84 (d).8.How many members of the TPSAC will be voting members and how many will be non-voting members?There will be nine voting and three non-voting members. Of the nine voting members, seven will be health care professionals practicing in the area o
11、f oncology, pulmonology, cardiology, toxicology, pharmacology, addiction, or other relevant specialty. One member will be an officer or employee of a state or local government or the Federal government, and the final member will be a representative of the general public. The three non-voting members
12、 will be identified with industry interests. These members will include one representative of the tobacco manufacturing industry, one representative of the interests of tobacco growers, and one representative for the interests of the small business manufacturing industry.9.How long will each member
13、serve on the Tobacco Products Scientific Advisory Committee?Members will serve for overlapping terms of up to four years.10. If I nominate myself as a nonvoting industry representative can I still participate in the selection process?If you nominate yourself or someone has nominated you for the indu
14、stry representative member on the TPSAC then you will not be able to participate in the interested industry organization selection process. 11. Can industry organizations participate in the selection process if one or more of there employees have been nominated or self nominated for a nonvoting indu
15、stry representative?Interested Industry organizations from the same industry organization as a person that has been nominated or self nominated may still be part of the interested industry organization. - 3 -12. What is the deadline for submitting a nomination or self nomination to serve as a nonvot
16、ing Industry Representative on the Tobacco Products Scientific Advisory Committee?FDA has extended this deadline from September 25, 2009, to October 26, 2009 to allow industry participation in the selection process as well as the request for nominations for nominations for a nonvoting industry representative. http:/edocket.access.gpo.gov/2009/pdf/E9-23009.pdf13. What is the deadline for submitting a nomination or self nomination to se
