[Federal Register Volume 84, Number 42 (Monday, March 4, 2019)] [Notices] [Pages 7388-7390] From the Federal Register Online via the Government Publishing Office [www.gpo.gov] [FR Doc No: 2019-03828] ----------------------------------------------------------------------- DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2012-N-0280] Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Financial Disclosure by Clinical Investigators AGENCY: Food and Drug Administration, HHS. ACTION: Notice. ----------------------------------------------------------------------- SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995. DATES: Fax written comments on the collection of information by April 3, 2019. ADDRESSES: To ensure that comments on the information collection are received, OMB recommends that written comments be faxed to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, Fax: 202-395-7285, or emailed to [email protected]. All comments should be identified with the OMB control number 0910-0396. Also include the FDA docket number found in brackets in the heading of this document. FOR FURTHER INFORMATION CONTACT: Amber Sanford, Office of Operations, Food and Drug Administration, Three White Flint North, 10A-12M, 11601 Landsdown St., North Bethesda, MD 20852, 301-796-8867, [email protected]. SUPPLEMENTARY INFORMATION: In compliance with 44 U.S.C. 3507, FDA has submitted the following proposed collection of information to OMB for review and clearance. Financial Disclosure by Clinical Investigators OMB Control Number 0910-0396--Extension Respondents to this collection are sponsors of marketing applications that contain clinical data from studies covered by the regulations. These sponsors represent pharmaceutical, biologic, and medical device firms. Respondents are also clinical investigators who provide financial information to the sponsors of marketing applications. Table 1 of this document shows information that is the basis of the estimated number of respondents in tables 2 through 4. Table 1--Estimated Number of Applications, Clinical Trials, and Investigators Subject to the Regulation by Type of Application \1\ ---------------------------------------------------------------------------------------------------------------- Total number Number of Application type of applications Number of trials Number of applications affected investigators ---------------------------------------------------------------------------------------------------------------- Drugs: [[Page 7389]] New drug application (NDA), 35 26 3 to 10............... 3 to 100. new molecular entity (NME). NDA nonNME: NDA efficacy supplement. 173 86 1 to 3................ 10 to 30. Abbreviated new drug 1,152 250 1.1................... 2. application (ANDA). ANDA supplement......... 6,774 383 1..................... 2. Biologics: Biologics license 22 19 3 to 10............... 3 to 100. application (BLA). BLA efficacy supplement..... 16 14 1 to 3................ 10 to 30. Medical Devices: Premarket approval (PMA).... 48 48 1 to 3................ 10 to 20. PMA supplement.............. 23 23 1 to 3................ 3 to 10. Reclassification devices.... 3 1 1..................... 3 to 10. 510(k)...................... 4,000 200 1..................... 3 to 10. ---------------------------------------------------------------------------------------------------------------- \1\ Source: Agency estimates. In the Federal Register of September 27, 2018 (83 FR 48819), FDA published a 60-day notice requesting public comment on the proposed collection of information. FDA received one comment, however, it was not responsive to the four collection of information topics solicited and therefore this comment will not be discussed in this document. FDA estimates the burden of this collection of information as follows: Reporting Burden Under Sec. 54.4(a) (21 CFR 54.4(a)), applicants submitting an application that relies on clinical studies must submit a complete list of clinical investigators who participated in a covered clinical study, and must either certify to the absence of certain financial arrangements with clinical investigators (Form FDA 3454) or, under Sec. 54.4(a)(3), disclose to FDA the nature of those arrangements and the steps taken by the applicant or sponsor to minimize the potential for bias (Form FDA 3455). FDA estimates that almost all applicants submit a certification statement under Sec. 54.4(a)(1) and (a)(2). Preparation of the statement using Form FDA 3454 should require no more than 1 hour per study. The number of respondents is based on the estimated number of affected applications. When certification is not possible and disclosure is made using Form FDA 3455, the applicant must describe, under Sec. 54.4(a)(3), the financial arrangements or interests and the steps that were taken to minimize the potential for bias in the affected study. As the applicant would be fully aware of those arrangements and the steps taken to address them, describing them will be straightforward. The Agency estimates that it will take about 5 hours to prepare this narrative. Based on our experience with this collection, FDA estimates that approximately 10 percent of the respondents with affected applications will submit disclosure statements. Table 2--Estimated Annual Reporting Burden \1\ ---------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of responses per Total annual Average burden Total hours respondents respondent responses per response ---------------------------------------------------------------------------------------------------------------- Certification--54.4(a)(1) and 1,050 1 1,050 1 1,050 (a)(2)--Form FDA 3454.......... Disclosure--54.4(a)(3)--Form FDA 105 1 105 5 525 3455........................... ------------------------------------------------------------------------------- Total....................... .............. .............. .............. .............. 1,575 ---------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. Recordkeeping Burden Under Sec. 54.6, the sponsors of covered studies must maintain complete records of compensation agreements with any compensation paid to nonemployee clinical investigators, including information showing any financial interests held by the clinical investigator, for 2 years after the date of approval of the applications. Sponsors of covered studies maintain many records regarding clinical investigators, including protocol agreements and investigator resumes or curriculum vitae. FDA estimates that an average of 15 minutes will be required for each recordkeeper to add this record to the clinical investigator's file. Table 3--Estimated Annual Recordkeeping Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of Average burden 21 CFR section Number of records per Total annual per Total hours \2\ recordkeepers recordkeeper records recordkeeping -------------------------------------------------------------------------------------------------------------------------------------------------------- Recordkeeping--54.6................................................ 1,050 1 1,050 0.25 263 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Numbers have been rounded. [[Page 7390]] Third-Party Disclosure Burden Under Sec. 54.4(b), clinical investigators supply to the sponsor of a covered study financial information sufficient to allow the sponsor to submit complete and accurate certification or disclosure statements. Clinical investigators are accustomed to supplying such information when applying for research grants. Also, most people know the financial holdings of their immediate family and records of such interests are generally accessible because they are needed for preparing tax records. For these reasons, FDA estimates that the time required for this task may range from 5 to 15 minutes; we used the mean, 10 minutes, for the average burden per disclosure. The number of respondents is the sum of the number of affected applications multiplied by the mean of the estimated number of investigators for each application type (rounded) (see table 1 of this document). Table 4--Estimated Annual Third-Party Disclosure Burden \1\ -------------------------------------------------------------------------------------------------------------------------------------------------------- Number of 21 CFR section Number of disclosures per Total annual Average burden Total hours \2\ respondents respondent disclosures per disclosure -------------------------------------------------------------------------------------------------------------------------------------------------------- 54.4(b)--Clinical Investigators.................................... 7,894 1 7,894 0.17 1,342 -------------------------------------------------------------------------------------------------------------------------------------------------------- \1\ There are no capital costs or operating and maintenance costs associated with this collection of information. \2\ Numbers have been rounded. Our estimated burden for the information collection reflects an overall increase of 222 hours and a corresponding increase of 893 responses/records. We attribute this adjustment to an increase in the number of affected applications and the number of investigators. No program changes were made. Dated: February 26, 2019. Lowell J. Schiller, Acting Associate Commissioner for Policy. [FR Doc. 2019-03828 Filed 3-1-19; 8:45 am] BILLING CODE 4164-01-P