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DEPARTMENT OF HEALTH HUMAN SERVICES Public Health Service

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Food and Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993

Jami Miller. Regulatory Aflair Date: July 6. 2010
Alfred Mann Foundation In response refer to: F2008-3514

25134 Rye Canyon Loop. Suite 200
Santa Clarita, CA 91355

Dear Requester:

In response to your request (copy enclosed) for record(s) from the Food and Drug Administration pursuant to the
Freedom oflnformation Act:

After searching our files, we did not find the requested records.

We have no disclosable information as requested.

We are enclosing the requested record(s). P890055, P800036. P860004 



This is a partial response. Further response will be made.
Certain material has been deleted from the records furnished to you because a preliminary review of the records
indicated that the deleted information is not required to be publicly disclosed and that disclosure is not
appropriate. FDA has taken this approach to facilitate the process ofresponding to you. If you dispute FDA's
preliminary determination with respect to these records and would like FDA to reconsider any particular deletion,
please let us know in writing at the address listed below within 30 days from the date ofthis letter. If we do not
receive a response in that time period. we will consider the matter closed with respect to these records. If you do
request further consideration and ifthe agency then formally denies your request for any or all ofthe previously-
withheld information. you would have the right to appeal that decision. Any letter ofdenial will explain how to
make this appeal.

Food and Drug Administration

Freedom of Information Staff

10903 New Hampshire Avenue

?"066-5262

Silver Spring, 2WD 20993-0002
?Should the agency then deny this information. you would have the right to appeal such denial. Any letter of denial will
explain how to make this appeal."

The following charges will be included in a invoice:
Reproduction: $1.00 Search: $46.00 Review: $46.00 Other: 50.00 Total: 5 93.00
See addendum for comment(s).

The above total may not re?ect final charges for this request. Please DO NOT send payment unless you secure an
invoice for the total fee. can be of further assistance please contact me at (301) 796?5954 or email me at


Sincerely yours,

all-mm. W7. Mild/4'0

Consumer Safety Of?cer

Freedom of Information Branch

Of?ce of h?lanagcment Operations

Center for Devices and Radiological Health
Food and Drug Administration