US embassy cable - 05BRASILIA1146

UNCLAS BRASILIA 001146 
 
SIPDIS 
 
STATE PASS TO FDA/INTL PROGRAMS FOR ASSOCIATE DIRECTOR FOR 
THE AMERICAS DESK CHARLES GAYLORD 
 
E.O. 12958: N/A 
TAGS: TBIO, KSCA, OSCI, BR 
SUBJECT: APPROVAL OF FDA RESEARCH PROJECT ENTITLED 
"ASSESSMENT OF IDURONATE-2-SULFATASE IN MPS II (HUNTER 
SYNDROME) (AIM) PIVOTAL TRIAL" WITH RECOMMENDATION 
 
REF:  (A) 04 BRASILIA 01922, (B) 04 STATE 164536 
 
CORRECTED VERSION - PLEASE SEE SUBJECT LINE 
 
1. On April 18, 2005, Embassy received from the Brazilian 
Ministry of Foreign Affairs, Division of Science and 
Technology, (DCTEC/MFA) an official notification (number 152, 
dated April 15, 2005) approving the research project proposal 
entitled "ASSESSMENT OF IDURONATE-2-SULFATASE IN MPS II 
(HUNTER SYNDROME) (AIM) PIVOTAL TRIAL," (number RFA-FDA-OPD- 
2004-1), under the direction of Dr. Roberto Giugliani, of 
Hospital das Clinicas de Porto Alegre, Rio Grande do Sul. An 
informal translation of the approval notice follows: 
 
2. Begin text: 
 
Dear Ms. Norman, 
 
I hereby inform you that the Brazilian government has 
reviewed the project entitled "Assessment of Iduronate-2- 
Sulfatase in MPS II (Hunter syndrome) (AIM) Pivotal Trial" to 
be developed by Dr. Roberto Giugliani from Hospital das 
Clinicas de Porto Alegre, UFRGS, with financial support from 
the Food and Drug Administration (FDA). 
 
2) The aforesaid protocol was approved with a recommendation. 
Please see National Commission on Ethics in Research (CONEP) 
considerations below: 
 
a)"requests in referred opinion have been duly complied with. 
However, it is recommended that: 
 
1 - the sentence "or until sponsor decides to discontinue the 
study" in subclause "Continued Protein Supply" be removed. 
 
2 - researchers file a report with CEP assessing 
advantages/needs for continued drug use. 
 
b) the project generally meets the basic requirements in 
Resolutions CNS 196/96 and 292/99 on Guidelines and 
Regulations for Research Involving Human Beings; 
 
c) the project was approved by the Committee of Ethics in 
Research (CEP) of the aforementioned institution. 
In consideration of the above information, CONEP, drawing its 
authority from Resolution CNS 196/96, declares its approval 
of the proposed research project which will also include CEP 
monitoring of recommendations set forth in a) above." 
 
3) The Ministry of Science and Technology (MCT) has reviewed 
and approved the above mentioned protocol, but has reminded 
Brazilian researchers that under the legislation in force 
they must request the required authorization from the Council 
for Scientific and Technological Development (CNPq) prior to 
shipping collected data and/or biological material to foreign 
countries. 
 
Yours truly, 
 
Vergniaud Elyseu Filho 
(Signature) 
Head of the Division of Science and Technology 
Ministry of Foreign Affairs 
 
End text of translation. 
 
3. The Embassy sees no adverse foreign policy implications 
with respect to this research project. We reiterate the 
importance of complying with Brazilian law on the export of 
data and biological material and medical research involving 
human beings. 
 
4. Embassy Science and Health Counselor Patricia Norman would 
like to establish contact with the International Officer at 
FDA responsible for this grant. Please send email to 
normanpd@state.gov 
DANILOVICH