STATEMENT OF AUTHORITY 


AND 


CONFIDENTIALITY COMMITMENT FROM 


THE UNITED STATES FOOD AND DRUG ADMINISTRATION 


NOT TO PUBLICLY DISCLOSE NON-PUBLIC INFORMATION SHARED 


BY 


THE EXPORT INSPECTION COUNCIL OF INDIA, 


MINISTRY OF COMMERCE AND INDUSTRY 


The Export Inspection Council of India, Ministry of Cmmnerce and Industry (EIC) is 

authorized to disclose non-public information to the United States Food and Drug 

Administration (FDA) regarding EIC-regulated products as part of cooperative law 

enforcement or cooperative regulatory activities. 

FDA understands that some of the information it receives from EIC may include nonpublic information exempt from public disclosure under the laws and regulations of 

India, which is confidential commercial information; trade secret information; personal 

privacy information; law enforcement infonnation; designated national security 

information ; or internal, pre-decisional information. FDA understands that this nonpublic infonnation is shared in confidence and that EIC considers it critical that FDA 

maintain the confidentiality of the information. Public disclosure of this infonnation by 

FDA could seriously jeopardize any further scientific and regulatory interactions between 

EIC and FDA. EIC will advise FDA of the non-public status of the information at the 

time that the information is shared. 

Therefore, FDA certifies that it: 

1. has the authority to protect from public disclosure such non-public information 

provided to FDA in confidence by EIC; 

2. will not publicly disclose such EIC-provided non-public information without the 

written authorization of the owner of the information, the written authorization from the 

individual who is the subject of the personal privacy information, or a written statement 

from EIC that the information no longer has non-public status; 

3. will inform EIC promptly of any effort made by judicial or legislative mandate to 

obtain EIC-provided non-public information from FDA. If such judicial or legislative 

mandate orders disclosure of EIC-provided non-public information, FDA will take all 

appropriate legal measures in an effort to ensure that the infonnation will be disclosed in 

a manner that protects the infonnation from public disclosure; and 
Date 

4. will promptly inform EIC of any changes to the United States of America ' s laws, 

or to any relevant policies or procedures, that would affect FDA ' s ability to honor the 

commitments in this document. 

Signed in \ ",t11'11 S(v I on bI0'o \:l-'1 tf. two original copies each in Hindi 

and English language. Th wo texts shall be equally authentic, in case of any divergence 

in the interpretation, the English text shall prevail. 

Signed on behalf of FDA: 

Howard R. Sklamberg, J.D. 

Deputy Commissioner 

Global Regulatory Operations and Policy 

United States Food and Drug Administration 

I 0903 New Hampshire A venue 

Silver Spring, MD 20993 

United States of America 
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