21 CFR Part 54Biologics, Drugs, Medical devices, Reporting and recordkeeping requirements. A comment from one trade association stated that such interests should not concern FDA, and a comment from another trade association said that, in this regard, it should be sufficient to FDA for a sponsor of a covered study to be willing to use an investigator. (c) Narrowed definition to principal and subinvestigators and their immediate families. AGENCY: Food and Drug Administration, HHS. 54.2 (d) of FDA's proposed rule was too broad, FDA has revised this definition to clarify that it includes only principal and subinvestigators who are directly involved in the treatment and evaluation of research subjects and their spouses and dependent children. Section 314.60 is amended in paragraph (a) by adding a new sentence at the end of the paragraph to read as follows: Sec. Authority: 21 U.S.C. 351, 352, 353, 360, 360c-360j, 371, 372, 373, 374, 375, 379, 379e, 381. 54.6. Because relevant clinical trials for most new drug and biological products are blinded and involve multiple sites and multiple investigators, the agency does not anticipate significant modifications to protocols for most of these products. FDA judged the incremental costs associated with this new activity to be negligible because firms already maintain records of compensation as standard business practice and the required records pertaining to the financial interests of the investigators will typically consist of only one additional piece of paper per investigator. Section 314.94 is amended by adding new paragraph (a)(13) to read as follows: Sec. (Sponsors are encouraged to meet with FDA to discuss protocol design and this is common practice with sponsors of covered clinical studies of human drugs and biologics). PART 320--BIOAVAILABILITY AND BIOEQUIVALENCE REQUIREMENTS. These comments said the rule would significantly affect small firms because of such factors as ``the thousands of investigators who would need to provide information to sponsors,'' the composition of the medical device industry, 98 percent of which is made of small businesses, and the ``severe paperwork burden.''. A CFP is a financial adviser who has earned a certification that indicates in-depth knowledge of financial planning. 312.57 to ease recordkeeping requirements and has added Sec. 2. One comment said that employees who are part-time employees of the applicant should also be exempt. One comment from a pharmaceutical firm maintained that, while not overly onerous for investigators, the accumulated paperwork would probably cost pharmaceutical companies in excess of $1 to 1.5 million annually. Not only that, but he also said in the same article that there is a need for these persons to comply with professional and ethical standards. 54.4 Certification and disclosure requirements. Included in the estimate is the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing each collection of information. The information you are listing and documenting also may be provided to other university offices upon their request, such as your school's Financial Aid office or Student Financial Services (SFS). Two comments suggested that, before the final rule becomes effective, FDA conduct a series of educational fora on these new requirements to ensure that they are understood by the industry that must comply with them. 13 of section II of this document for a summary and response to these comments). Certified Financial Planner (CFP) The Certified Financial Planner certification is for professional financial planners. Section 812.110 is amended by redesignating paragraph (d) as paragraph (e) and adding new paragraph (d) to read as follows: Sec. FDA is also clarifying that the period for which this disclosure must be made includes the period during the conduct of the study and for 1 year following completion of the study. To further strengthen the authenticity of your financial certificate, you can stamp your common seal. FDA has also recalculated its estimate of the total number of hours that will be necessary to complete the information collection requirements associated with this final rule. This analysis, which is summarized in section IV.B of this document, is available for review at the Dockets Management Branch (address above). PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR MANUFACTURERS AND DISTRIBUTORS OF DEVICES. Costs may be incurred before an application is submitted when a clinical investigator has a disclosable interest and the sponsor modifies a trial protocol or alters procedures to minimize the potential for investigator bias. The applicant is responsible for making the appropriate certification or disclosure statement where the applicant either contracted with one or more clinical investigators to conduct the studies or submitted studies conducted by others not under contract to the applicant. (b) Any person who contracts with another party to conduct a bioequivalence study from which the data are intended to be submitted to FDA as part of an application submitted under part 314 of this chapter shall obtain from the person conducting the study sufficient accurate financial information to allow the submission of complete and accurate financial certifications or disclosure statements required under part 54 of this chapter and shall maintain that information and all records relating to the compensation given for that study and all other financial interest information required under part 54 of this chapter for 2 years after the date of approval of the application. The agency treats data from clinical investigators who are the employees of sponsors with maximum scrutiny and will continue to do so because such employees can be assumed to have significant financial interests in the outcome of studies, often including stock options and significant equity interest in their employers. (a) The applicant (of an application submitted under sections 505, 506, 507, 519(k), 513, or 515 of the Federal Food, Drug, and Cosmetic Act, or section 351 of the Public Health Service Act) that relies in whole or in part on clinical studies shall submit, for each clinical investigator who participated in a covered clinical study, either a certification described in paragraph (a)(1) of this section or a disclosure statement described in paragraph (a)(3) of this section. (g) Applicant means the party who submits a marketing application to FDA for approval of a drug, device, or biologic product. FDA, intends, therefore, to proceed on a case-by-case basis in determining whether the circumstances outweigh the privacy interest of the clinical investigator(s). This requirement will apply to any covered clinical study of a drug or device submitted in a marketing application that the applicant or FDA relies on to establish that the product is effective, including studies that show equivalence to an effective product, or that make a significant contribution to the demonstration of safety. As noted in the preamble to the proposed rule, this amendment provides for sponsors to acquire financial information from clinical investigators before starting clinical investigations. Some comments suggested that FDA delete the requirement for disclosure of significant payments of other sorts entirely. Amendments to Regulations for Biologicals. Section 814.112 is amended by adding new paragraph (a)(4) to read as follows: (4) The HDE is not accompanied by a statement of either certification or disclosure, or both, as required by part 54 of this chapter. 3501-3520). In new Sec. The investigator shall promptly update this information if any relevant changes occur in the course of the investigation or for 1 year following completion of the study. . CFP professionals meet rigorous education, training and ethical standards, and are committed to serving their clients' best interests today to prepare them for a more secure tomorrow. . (d) Clinical investigator means any listed or identified investigator or subinvestigator who is directly involved in the treatment or evaluation of research subjects. (4) Financial disclosure information. FDA disagrees with these comments and believes there is factual justification to require collection of this information. The title, description, and respondent description of the information collection requirements are shown below with an estimate of the annual reporting and recordkeeping burden. One comment requested that FDA clarify whether 5 percent of total equity refers to 5 percent of the investigator's equity or 5 percent of the equity of the corporation and said that holding 5 percent of equity of publicly traded companies is only relevant if it represents a significant portion of the investigator's net worth. Section 320.36 is amended by designating the existing text as paragraph (a) and by adding new paragraph (b) to read as follows: Sec. In addition, the PHS final rule and the NSF statement of policy have defined a significant financial interest to be ``anything of monetary value, including but not limited to, salary or other payments for services (e.g., consulting fees or honoraria); equity interests (e.g., stocks, stock options or other ownership interests); and intellectual property rights (e.g., patents copyrights and royalties from such rights). Comments opposed to disclosure of such interests said that such a requirement might not be realistic inasmuch as it is often not possible to identify every company that is in competition with the sponsor of the covered study. Many factors could affect the believability of data derived from clinical studies, such as the endpoint used, number of investigators, the methods of blinding and the method of evaluation. Description of Respondents: Respondents are sponsors of marketing applications containing clinical data from studies covered by the regulation. The authority citation for 21 CFR part 807 continues to read as follows: Authority: 21 U.S.C. There is no firm basis for estimating the frequency of disclosure by applicants. 321, 351, 352, 353, 355, 360, 371. 16. SBA defines a drug company (Standard Industrial Code (SIC) 2834) as small if there are fewer than 750 employees; whereas biologic (SIC's 2835 and 2836) and medical device companies (SIC's 3841, 3842, 3843, 3844, 3845, and 3851) are considered small if employment is less than 500. 360c, 360d, 360e, 360i, 360j, 371, 374. So, it is not surprising if many people do not completely understand financial advisors at all. Some comments suggested that FDA only require disclosure of payments made directly to the clinical investigator and not to an institution, such as a university that employs the investigator. Original documents are preferred, but scanned/fax copies will be accepted for the initial review process. 374) (the act) expressly prohibits FDA from inspecting financial data of companies and that FDA cannot obtain access to this information by having the request come from a reviewing division at headquarters rather than a field investigator. 5. 54.5(c). 54.4(c) in this final rule. 321, 351, 352, 355, 357, 371. In any consideration of disclosure issues, it is useful to keep in mind FDA's expectation that these issues will not affect the great majority of clinical investigators who participate in studies of FDA- regulated products. These comments said that public disclosure of this information is necessary in order to discourage the occurrence of substantive financial abuses at the outset of the clinical trial process.
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