This is a critical question, as each of the specific aims in the application must meet the following criteria to be considered responsive:

1.     Address one or more of the interest areas listed in the FOA.
2.    Fall within the scope of FDA CTP’s regulatory authority.

As such, applicants are strongly encouraged to contact the scientific research contacts listed in the FOA for feedback about responsiveness prior to submitting an application. Upon receipt, applications will be evaluated for responsiveness by the Food and Drug Administration (FDA) Center for Tobacco Products (CTP) and participating NIH Institutes. Only applications that are within the scope of the areas listed in the FOA and FDA CTP's regulatory authority will be reviewed.

Your application title, abstract, and specific aims are used to make this determination, so it is important that you are clear about your proposed scientific aims and how they may potentially inform CTP's regulatory authority. Staff reviewing your application will refer to other parts of the application if responsiveness is unclear based on title, abstract, and specific aims. If your application is deemed responsive, it will undergo scientific peer review by experts convened specifically for this FOA (by the NIH Center for Scientific Review). If your application is deemed nonresponsive, it will be withdrawn prior to evaluation of its scientific merit, i.e., peer review.

The Family Smoking Prevention and Tobacco Control Act gave FDA responsibility for and authority to, among other things:

1. Restrict cigarettes and smokeless tobacco retail sales to youth.
2. Restrict the sale and distribution of tobacco products, including advertising and promotion, as appropriate to protect public health.
3. Review modified risk tobacco products, such as those marketed for use to reduce harm, prior to their introduction to the market.
4. Adjust warning labels for cigarettes and smokeless tobacco products in order to promote greater public understanding of the risks of tobacco use.
5. Establish standards for tobacco products (for example, setting limits on harmful and potentially harmful constituents and nicotine levels) as appropriate to protect the public health.
6. Review new tobacco products prior to their introduction to the market.

The Family Smoking Prevention and Tobacco Control Act gives FDA the authority to regulate the manufacture, marketing, and distribution of tobacco products to protect public health and to reduce tobacco use by youth. In general, CTP’s regulatory authorities do NOT extend to the following:

1. Setting tax rates for tobacco products.
2. Regulating therapeutic products, such as those marketed to treat tobacco dependence.
3. Setting clean indoor air polices.
4. Regulating tobacco growing.

It depends. Mechanistic and or etiologic research is largely relevant to disease prevention or treatment, neither of which is within CTP's regulatory authority, so would not be considered responsive. These types of research may in some cases be responsive, but only if the outcomes of the research inform the mandate of the FDA CTP. For example, research comparing the mechanistic processes or underlying disease etiology of different tobacco products or their constituents may be considered responsive. As such, it is important to discuss your research concept with an NIH Scientific Contact.

No. CTP's regulatory authority does not extend to regulating therapeutic uses of tobacco products as this authority rests with other Centers within FDA. Examples of research projects that would be considered responsive include an observational study to examine the natural history of whether participants quit smoking cigarettes while using a different tobacco product, and assessing if communications regarding the health consequences of using tobacco products have an impact on usage rates.* In many of its key regulatory areas, CTP is charged with assessing the impact of tobacco products on the health of the population as a whole, taking into account both users of tobacco products and persons who do not currently use tobacco products as well as the increased or decreased likelihood that existing users of tobacco products will stop using such products; and the increased or decreased likelihood that those who do not use tobacco products will start using such products.

* The examples provided are illustrative and should not be viewed as definitive or comprehensive.

No. CTP's regulatory authority does not extend to the development or evaluation of interventions designed to promote cessation. Although a section of the Tobacco Control Act addresses medications to treat tobacco dependence (Sec. 918), this section of the Tobacco Control Act is under the authority of FDA's Center for Drug Evaluation and Research.

* The examples provided are illustrative and should not be viewed as definitive or comprehensive.

No. CTP does not regulate products intended for the treatment of disease, for example pharmacotherapy for treatment of cancer or emphysema or screening, physical activity or dietary interventions for heart disease.*

* The examples provided are illustrative and should not be viewed as definitive or comprehensive.

Yes. This proposal identifying differential effects of various tobacco products on disease would be responsive. Examples* might include:

1. Pulmonary function testing outcomes following use of various combustible tobacco products
2. Oral manifestations following use of various tobacco products, especially new and emerging tobacco products

* The examples provided are illustrative and should not be viewed as definitive or comprehensive.

Proposals identifying biomarkers of specific tobacco product exposure and/or disease and those with the potential to differentiate exposure of differing tobacco products could be considered responsive. Examples* include:

1. Biomarkers to measure exposure to new and emerging tobacco products
2. Biomarkers of disease (e.g., cancer, cardiovascular disease, pulmonary disease, reproductive and developmental effects) that can be associated with specific measures of tobacco exposure
3. Development of a nonclinical biomarker of disease coupled to traditional toxicology and/or pharmacology studies to provide a relevant framework for the regulatory application
4. Studies linking biomarkers of disease in nonclinical models that translate to biomarkers that are measurable in the clinical setting
5. Magnitude of changes in biomarkers of that translates into clinically meaningful impacts on human health outcomes
6. Novel biological and physiological markers (including genetic and epigenetic markers) that are predictive of smoking-related and smokeless tobacco-related adverse health outcomes.
7. Biomarker research may fall within the scope of one or more of the research domains identified in a CTP-supported FOA, depending on the intended use of the biomarker. However, there is research that will remain outside of FDA-CTP authorities such as biomarker research, for which the primary focus is to inform treatment.

* The examples provided are illustrative and should not be viewed as definitive or comprehensive.

If the research provides information on outcomes such as motor activity, memory, or neuronal responses to particular ligands, the research is likely not appropriate. Research to rapidly screen tobacco constituents for activity at the nicotinic receptor to determine their dependence potential would be considered responsive.*

* The examples provided are illustrative and should not be viewed as definitive or comprehensive

It depends upon the specific policies being examined, and whether they fall under the purview of the FDA CTP. Studies evaluating the impact of a tobacco tax increase are not responsive, as CTP does not have regulatory authority regarding tax rates on tobacco products. Similarly, CTP does not have authority over the sale of tobacco cessation medications, so, for example, a study evaluating the effectiveness for tobacco cessation of providing free nicotine replacement therapy would not be considered responsive. Studies evaluating the impact of a tobacco advertising restriction, a ban on the sale of flavored tobacco products, or restrictions on the sale of single serving products, however, may be considered responsive.*

* The examples provided are illustrative and should not be viewed as definitive or comprehensive.

Unlike state or local policymaking, where public support can be an important factor in the adoption and implementation of policies, public opinions cannot be used to support federal regulations.

FDA is committed to funding and conducting research on graphic health warnings so that it may fulfill its statutory requirement to issue a rule requiring graphic health warnings on cigarette packages and advertisements. Of particular interest would be research to provide further evidence that graphic health warnings are effective, to inform the development of new graphic health warnings, or to inform the development of methods for assessing the effectiveness of graphic health warnings. This research may be conducted using the images proposed by FDA in June 2011, images used internationally, or new images.

Applications will be selected for funding based on scientific merit, current research priorities, availability of funds and FDA CTP current research priorities.

It depends on the nature and scope of the research projects proposed. Applicants may request assignment to a particular Institute in their cover letter, but the NIH will make the final determination regarding Institute assignment.

No. An Interim Report will be due every six (6) months following the project start date, as well as the annual progress report and all reports at the time of grant close-out. It is critical that CTP funds be used only to support research that is responsive to FDA's authority to regulate the manufacture, marketing and distribution of tobacco products. Any proposed change in scope or specific aims requires pre-approval.

No. An Interim Report will be due every six (6) months following the project start date, as well as the annual progress report and all reports at the time of grant close-out. It is critical that CTP funds be used only to support research that is responsive to FDA's authority to regulate the manufacture, marketing and distribution of tobacco products. Any proposed change in scope or specific aims requires pre-approval.

As mandated in the Tobacco Control Act, FDA is authorized to collect fees from tobacco product manufacturers and importers for its activities related to the regulation of the manufacture, distribution and marketing of tobacco products. Although the tobacco user fees are specified in statute, Congress must actually appropriate the funds before FDA can obligate them. The tobacco industry has no control over CTP funding decisions. FDA uses some of these funds to award research grants.

The Shelby Amendment tasks the Office of Management and Budget (OMB) to change OMB Circular A-110 so that all federally-funded research data can be accessed through the mechanisms set forth in the Freedom of Information Act (FOIA). With regard to an FOA, the research findings generated may be used to provide scientific evidence informing the regulation of the manufacture, distribution, and marketing of tobacco products to protect public health. If research data are cited publically in support of regulation, institutions of higher education, hospitals, and other nonprofit organizations are subject to the FOIA as outlined in Revised Circular A-110.

Several laws govern the confidentiality of tobacco product information submitted to FDA, including sections 301(j) and 906(c) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), the Trade Secrets Act, and the Freedom of Information Act, as well as FDA's implementing regulations. FDA's general regulations concerning the public availability of FDA records are contained in 21 CFR Part 20. Regarding the reporting of constituents, the FD&C Act requires tobacco product manufacturers and importers to report quantities of harmful and potentially harmful constituents (HPHCs) in tobacco products or tobacco smoke by brand and sub-brand. The FD&C Act also directs the Agency to publish a list of HPHCs by brand and by quantity in each brand and sub-brand, in a format that is understandable and not misleading to a layperson.

The information needed in an ITP request may vary depending on the proposed ITP and the type of study. FDA needs to determine whether the product is a tobacco product, whether the tobacco product is within our current jurisdiction, whether the tobacco product is an ITP, and whether the study products will be provided to human subjects. For example, if one makes a change in labeling of a commercially marketed tobacco product and it will not be used by human subjects, no ITP request is needed. If one makes a change in labeling of a commercially marketed tobacco product and there will be actual use by human subjects, then FDA recommends that an ITP request come to CTP for review, but it is likely that chemistry, engineering, and manufacturing will not be needed.