Agency Information Collection Activities; Proposed Collection; Comment Request: Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans

AGENCY:

Food and Drug Administration, HHS.

ACTION:

Notice.

SUMMARY:

The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection resulting from investigational new drug (IND) safety reporting requirements and safety reporting requirements for bioavailability and bioequivalence studies.

DATES:

Submit either electronic or written comments on the collection of information by August 12, 2013.

ADDRESSES:

Submit electronic comments on the collection of information to http://www.regulations.gov . Submit written comments on the collection of information to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane., rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT:

Ila S. Mizrachi, Office of Information Management, Food and Drug Administration, 1350 Piccard Dr., P150-400B, Rockville, MD 20850, 301-796-7726, Ila.mizrachi@fda.hhs.gov.

SUPPLEMENTARY INFORMATION:

Under the PRA (44 U.S.C. 3501-3520), Federal Agencies must obtain approval from the Office of Management and Budget (OMB) for each collection of information they conduct or sponsor. “Collection of information” is defined in 44 U.S.C. 3502(3) and 5 CFR 1320.3(c) and includes Agency requests or requirements that members of the public submit reports, keep records, or provide information to a third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A)) requires Federal Agencies to provide a 60-day notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, before submitting the collection to OMB for approval. To comply with this requirement, FDA is publishing notice of the proposed collection of information set forth in this document.

With respect to the following collection of information, FDA invites comments on these topics: (1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility; (2) the accuracy of FDA'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 respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans—(OMB Control Number 0910-0672)—Extension

In the Federal Register of September 29, 2010 (75 FR 59935), FDA published a document entitled “Investigational New Drug Safety Reporting Requirements for Human Drug and Biological Products and Safety Reporting Requirements for Bioavailability and Bioequivalence Studies in Humans.” The document clarified the Agency's expectations for timely review, evaluation, and submission of relevant and useful safety information and implemented internationally harmonized definitions and reporting standards for IND safety reports. The document also required safety reporting for bioavailability and bioequivalence studies. The document was intended to improve the utility of IND safety reports, expedite FDA's review of critical safety information, better protect human subjects enrolled in clinical trials, and harmonize safety reporting requirements internationally.

The rulemaking included the following information collection under the PRA that was not already included in 21 CFR 312.32 and approved under OMB control number 0910-0014.

Section 312.32(c)(1)(ii) and (c)(1)(iii) requires reporting to FDA, in an IND safety report, of potential serious risks from clinical trials within 15 calendar days for findings from epidemiological studies, pooled analyses of multiple studies, or other clinical studies that suggest a significant risk in humans exposed to the drug.

Section 312.32(c)(1)(iii) specifies the requirements for reporting to FDA in an IND safety report potential serious risks from clinical trials within 15 calendar days for findings from in vitro testing that suggest a significant risk to humans. FDA estimates that approximately 100 sponsors spend a total of approximately 12 hours per report to prepare and submit approximately 600 reports annually.

Section 312.32(c)(1)(iv) requires reporting to FDA in an IND safety report within 15 calendar days of any clinically important increase in the rate of occurrence of serious suspected adverse reactions over that listed in the protocol or investigator brochure. FDA estimates that approximately 10 sponsors spend a total of approximately 12 hours per report to prepare and submit approximately 10 reports annually.

The rulemaking also included new information collection under the PRA by requiring safety reporting for bioavailability and bioequivalence studies (21 CFR 320.31(d)). FDA estimates that approximately 10 sponsors spend a total of approximately 14 hours per report to prepare and submit approximately 200 reports annually.