Biological Product

Information on Submitting an Investigational New Drug Application

All Biological IND submissions must be made in triplicate and should be addressed as follows:

Center for Biologics Evaluation and Research
HFM-99, Room 200N
1401 Rockville Pike
Rockville, MD 20852-1448

Filling Out Form FDA 1571

The numbers correspond to the numbered boxes on the form.

The sponsor is the person who takes responsibility for and initiates a clinical investigation. The sponsor may be a pharmaceutical company, a private or academic organization, or an individual. A Sponsor-Investigator is an individual who both initiates and conducts a clinical investigation and under whose immediate direction the investigational drug is being administered or dispensed. For administrative reasons, only one individual should be designated as sponsor.

If a pharmaceutical company will be supplying the drug, but will not itself be submitting the IND, the company is not the sponsor.

The date of submission is the date that the application is mailed to FDA.
The address is the address to which written correspondence from FDA should be directed. If this address is a post office box number, a street address must also be provided.
The telephone number is the number where the sponsor is usually available during normal working hours. A telephone number must be provided.
For name(s) of drug, list the generic name(s) and trade name, if available. Also, state the dosage form(s).
If an emergency IND number was previously assigned by FDA, or the Form FDA 1571 is being included with an amendment to the original IND, then that IND number should be entered here; otherwise, the space should be left blank.
Self-explanatory.
This section is to be completed by pharmaceutical firms that are conducting clinical studies in support of a marketing application. Sponsor-Investigators need not complete this section.
It is necessary for the sponsor to submit certain information with an IND (such as manufacturing and controls information, pharmacology and toxicology data, or data from prior human studies) unless that information has previously been submitted to FDA, AND the sponsor of the previously submitted information provides a letter authorizing FDA to refer to the information. In this case, the letter of authorization including the file identification (IND/DMF/NDA number) must be: 1) submitted to the authorizer's application and, 2) included in the initial submission of the new sponsor's IND. The sole exception to this requirement is when a marketed drug is used in the study, without modification to its approved packaging, in which case the marketed drug product must be identified by trade name, established name, dosage form, strength, and lot number.
Numbering of submissions is primarily intended for pharmaceutical firms. Sponsor-Investigators do not have to complete this section.
For an original IND submission, only the "Initial Investigational New Drug Application (IND)" box should be checked. For subsequent submissions, check ALL the boxes that apply since the submission may contain more than one type of information.

Requests to charge and Treatment Protocols must be submitted separately. Treatment INDs and Treatment Protocols are special cases and are not intended for single patient use. Before checking either of these boxes, the sponsor should be thoroughly familiar with the cited regulations and contact the appropriate FDA reviewing division to discuss the proposed treatment use.

For a Sponsor-Investigator IND, items 2, 3, and 4 may be briefly addressed in the cover letter or in a summary.

Where the investigational drug is obtained from a supplier in a final dosage form, items 5, 7, 8, and 9 may be referenced if authorization is given by the supplier (see explanation in section 9 above). If the investigational drug is prepared or altered in any way after shipment by the supplier, complete manufacturing (or compounding) and controls information, including information on sterility and pyrogenicity testing for parenteral drugs, must be submitted for that process in Item 7.

Item 6 requires that the protocol be submitted, along with information on the investigators, facilities, and Institutional Review Board (copies of the completed Form FDA 1572 with attachments would suffice for 6 b-d).

Item 7 also requires submission of either a claim of categorical exclusion from the requirement to submit an environmental assessment or an environmental assessment (21 CFR 25.15[a]). When claiming a categorical exclusion, the sponsor should include the following statements: "I claim categorical exclusion (under 21 CFR 25.31[e]) for the study(ies) under this IND. To my knowledge, no extraordinary circumstances exist."

This section does not pertain to a Sponsor-Investigator.
- 15. For a pharmaceutical firm, the name of the person responsible for monitoring the conduct of the clinical investigation, and reviewing and evaluating safety information, should be entered. For Sponsor-Investigator INDs, the investigator has this responsibility.

N.B. Certain important commitments that the IND sponsor makes by signing the form FDA 1571 are listed below box 15.

- 17. For an IND sponsored by a pharmaceutical firm or research organization, the name of the sponsor's authorizing representative would be entered and that individual must sign the form For a Sponsor-Investigator IND, the Sponsor-Investigator should be named and must sign the form.

- 19. Box 18 and 19 need not be completed if they duplicate boxes 3 and 4.

The date here is the date the form is signed by the sponsor.

Form FDA 1572:

Copies of Form FDA 1572 with its attachments may be sent by the Sponsor-Investigator to FDA to satisfy Form FDA 1571, box 12, item 6 b-d. Information can be supplied in the form of attachments (such as a curriculum vitae) rather than entering that information directly onto the form, but this should be so noted under the relevant section numbers.