Form 4 Extension Request

OMB#0925-0586 Exp. Date: 8/31/2015

Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing instructions, searching existing data sources, gathering and maintaining the data needed, and completing and reviewing the collection of information. An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB control number. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to: NIH, Project Clearance Branch, 6705 Rockledge Drive, MSC 7974, Bethesda, MD 20892-7974, ATTN: PRA (0925-0586). Do not return the completed form to this address.

Extension Request

Delayed Results - OPTIONAL: A responsible party may delay the deadline for submitting results information under Section 801 of the Food and Drug Administration Amendments Act if one of the two certification conditions below applies to the applicable clinical trial. Alternatively, the responsible party may request an extension of the results submission deadline for good cause. The extension must be granted by the NIH Director. To delay the results submission deadline using either of these mechanisms, all [*]-marked data elements are required, except as noted below.

Delay Results Type [*] : Select one

 Certify Initial Approval - trial completed before a drug, biologic or device studied in the trial is initially approved, licensed or cleared by the FDA (for any use)

 Certify New Use - the manufacturer of a drug, biologic or device is the sponsor of the trial and has filed or will file within one year, an application seeking FDA approval, licensure, or clearance of the new use (i.e., use not included in the labeling of the approved drug, biologic or device) studied in the trial

 Extension - request, for good cause, an extension of the deadline for the submission of results

Note: If a manufacturer (who is the responsible party) makes a certification under "Certify New Use" the manufacturer shall make such a certification with respect to each applicable clinical trial that is required to be submitted in an application or report to the FDA for licensure, approval, or clearance of the use studied in the clinical trial. [42 U.S.C. 282 (j)(3)(E)(v)(II)]

Intervention Name(s) [*] : Required when Delay Results Type is "Certify Initial Approval" or "Certify New Use." Provide the name of one or more drugs, biological products or devices to which the certification applies. For drugs use generic name; for other types of interventions provide a brief descriptive name. The name(s) entered should match Intervention Name(s) provided in the protocol section.

FDA Application Number(s): Provide at least one FDA application number (e.g., NDA, BLA, or PMA number), if available, when Delay Results Type is "Certify Initial Approval" or "Certify New Use."

Requested Submission Date [*] : Required when Delay Results Type is "Extension." Provide the month and year when results are expected to be submitted.

Explanation [*] : Required when Delay Results Type is "Extension." Provide a written explanation that demonstrates good cause for the extension. Provide sufficient information to allow for evaluation of the request. Note that "pending publication" is not considered "good cause" for an extension. (Limit: 999 characters)