Attachment III - Page 1 
DEPARTMENT OF HEALTH ANO HUMAN SERVICES 
Public health service 
FOOD ANO DRUG ADMINISTRATION 
Form Approved; OMB No. 0910-0014 
Expiration Date: February 29. 1984 . 
NOTICE OF CLAIMED INVESTIGATIONAL EXEMPTION 
FOR A NEW DRUG 
NOTE: 
No drug may be shipped or sludy initiated unless 
a complete statement has been received. 
(21 O-K 312. 1(a) (2D. 
Name of Sponsor Date 
Address Telephone ( ) 
Name of Investigational Drug 
FOR A DRUG: 
Food And Drug Administration 
Office of New Drug Evaluation (HFN-106) 
5600 Fishers Lane 
Rockville, Maryland 20857 
FOR A BIOLOGIC: 
Food and Drug Administration 
Office of Biologies (HFN-823) 
8800 Rockville Pike 
Bethesda, Maryland 20205 
Dear Sir: 
The sponsor, , submits 
this notice of claimed investigational exemption for a new drug under the provisions of section 505(i) of the Federal 
Food, Drug, and Cosmetic Act and § 3 12. 1 of Title 2 I of the Code of Federal Regulations. 
Attached hereto in triplicate are: 
1. The best available descriptive name of the drug, including to the 
extent known the chemical name and structure of any new-drug sub- 
stance, and a statement of how it is to be administered. (If the drug has 
only a code name, enough information should be supplied to identify 
the drug.) 
2. Complete list of components of the drug, including any reason- 
able alternates for inactive components. 
3. Complete statement of quantitative composition of drug, includ- 
ing reasonable variations that may be expected during the investiga- 
tional stage. 
4. Description of source and preparation of, any new-drug sub- 
stances used as components, including the name and address of each 
supplier or processor, other than the sponsor, or each new-drug sub- 
stance. 
5. A statement of the methods, facilities, and controls used for the 
manufacturing, processing, and packing of the new drug to establish 
and maintain appropriate standards of identity, strength, quality, and 
purity as needed for safety and to give significance to clinical investiga- 
tions made with the drug. 
6. A statement covering all information available to the sponsor 
derived from prcclinical investigations and any clinical studies and 
experience with the drug as follows: 
a. Adequate information about the preclinical investigations, in- 
cluding studies made on laboratory animals, on the basis of which the 
sponsor has concluded that it is reasonably safe to initiate clinical 
investigations with the drug: Such information should include identi- 
fication of the person who conducted each investigation; identification 
and qualifications of the individuals who evaluated the results and 
concluded that it is reasonably safe to initiate clinical investigations 
with the drug and a statement of where the investigations were con- 
ducted and where the records arc available for inspection; and enough 
details about the investigations to permit scientific review. The pre- 
clinical investigations shall not be considered adequate to justify 
clinical testing unless they give proper attention to the conditions of 
the proposed clinical testing. When this information, the outline of the 
plan of clinical pharmacology, or any progress report on the clinical 
pharmacology, indicates a need for full review of the preclinical data 
before a clinical trial is undertaken, the Department will notify the 
sponsor to submit the complete preclinical data and to withhold clinical 
trials until the review is completed and the sponsor notified. The f ood 
and Drug Administration will be prepared to confer with the sponsor 
concerning this action. 
b. If the drug has been marketed commercially or investigated (e.g. 
outside the United States), complete information about such distribu- 
tion or investigation shall be submitted, along with a complete bibli- 
ography of any publications about the drug. 
c. If the drug is a combination of previously investigated or mar- 
keted drugs, an adequate summary of preexisting information front 
preclinical and clinical investigations and experience with its compo- 
nents, including all reports available to the sponsor suggesting side- 
effects, contraindications, and ineffectiveness in use of such compo- 
nents: Such summary should include an adequate bibliography of 
publications about the components and may incorporate by reference 
any information concerning such components previously submitted 
by the sponsor to the Food and Drug Administration. Include a state- 
ment of the expected pharmacological effects of the combination. 
d. If the drug is a radioactive drug, sufficient data must be available 
from animal studies or previous human studies to allow a reasonable 
calculation of radiation absorbed dose upon administration to a human 
being. 
7. A total (one in each of the three copies of the notice) of all 
informational material, including label and Labeling, which is to be 
supplied to each investigator: This shall include an accurate description 
of the prior investigations and experience and their results pertinent 
to the safety and possible usefulness of the drug under the conditions 
of the investigation. It shall not represent that the safety or usefulness 
of the drug has been established for the purposes to be investigated. 
It shall describe all relevant hazards, contraindications, side-effects, 
and precautions suggested by prior investigations and experience with 
the drug under investigation and related drugs for the information 
of clinical investigators. 
8. The scientific training and experience considered appropriate 
by the sponsor to qualify the investigators as suitable experts to investi- 
gate the safety of the drug, bearing in mind what is known about the 
pharmacological action of the drug and the phase of the investigational 
program that is to be undertaken. 
9. The names and a summary of the training and experience of 
each investigator and of the individual charged with monitoring the 
progress of the investigation and evaluating the evidence of safety and 
effectiveness of the drug as it is received from the investigators, to- 
gether with a statement that the sponsor has obtained from each 
investigator a completed and signed form, as provided in subparagraph 
(12) or (13) of this paragraph, and that the investigator is qualified 
by scientific training and experience as an appropriate expert to undcr- 
FORM FDA 1571 110/83) 
PREVIOUS EDITION ARE OBSOLETE. 
[587] 
