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Freedom of Information Act Letter

Sample of Information Act Letter - FOIA Letter

To read guidelines on how to make a Freedom of Information Act request to the FDA, click here.

Below is a sample letter that you can use to select one or more of the 19 listed requests for records, or create your own individual request. You can then copy, edit, print, and send this to the FDA at the address on the letter. Note you are committing to paying a $25.00 charge if the FDA agrees to respond to your request. The more you request, the greater the FDA fees are likely to be. If you choose to file a Freedom of Information Act request, please read this letter carefully.



Date: _____________


Food and Drug Administration
Division of Freedom of Information
Office of Shared Services
Office of Public Information and Library Services
12420 Parklawn Drive
ELEM-1029
Rockville, MD 20857

Re: Freedom of Information Act Request

Dear FOIA staff:

Pursuant to the Freedom of Information Act, 5 U.S.C. §552, we wish to have copies at the earliest possible time, of any and all public records in the custody of the Food and Drug Administration that relate to the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” released in July 2011.

I specifically request all records, but no limited to:

  1. All records relating to the expenditure of time and money by FDA personnel (and outside consultants) in researching, drafting and promulgating the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  2. All records relating to communication of FDA personnel with pharmaceutical company representatives (including lobbyists) that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  3. All records relating to communication of FDA personnel with any member of Congress or Congress as a whole that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  4. All records relating to communication of FDA personnel with any member of private industry that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  5. All records relating to communication of FDA personnel with any scientific advisory committee, scientific advisory board, or individual scientist that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  6. All records relating to communication of FDA personnel with the FDA’s General Counsel’s office, or outside legal counsel that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  7. All records relating to FDA’s evaluation of safety issues relating to new dietary ingredients that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  8. All records relating to FDA’s decision to impose barriers that limit the ability of consumers to access new dietary ingredients that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  9. All records relating to communication of FDA personnel with other FDA personnel that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  10. All records relating to communication of FDA personnel with personnel from the Department of Health and Human Services that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  11. All records relating to communication of FDA personnel with personnel from the U.S. Treasury Department that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  12. All records relating to the cost benefit analysis performed by FDA or outside consultants that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  13. All records relating to financial estimates made by FDA personnel or outside consultants relating to the cost to the FDA of administering the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  14. All records relating to financial estimates made by FDA personnel or outside consultants relating to the cost burden of the dietary supplement industry in complying with the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  15. All records relating to what human and other resources within the FDA would be utilized to oversee and administer the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  16. All records relating to what human and other resources within the FDA would be moved or transferred from other positions within the FDA in order to oversee and administer the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  17. All records relating to communication of FDA personnel with the Department of Justice that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  18. All records relating to the steps taken by the FDA to ensure the Administrative Procedures Act was fully complied with as it relates to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
  19. All records relating to the steps taken by the FDA to ensure that provisions in the Dietary Supplement Health and Education Act of 1994 were fully adhered to as they relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.

When processing this request, please note that the D.C. Circuit has previously held that agencies have a duty to construe the subject material of FOIA requests liberally to ensure responsive records are not overlooked. See Nation Magazine, Washington Bureau v. U.S. Customs Service, 71 F.3d 885, 890 (D.C. Cir. 1995). Accordingly, you are hereby instructed that the term “record” includes, but is not limited to: 1) all email communications to or from any individual within your agency; 2) memoranda; 3) inter-agency communications; 4) sound recordings; 5) tape recordings; 6) video or film recordings; 7) photographs; 8) notes; 9) notebooks; 10) indices; 11) jottings; 12) message slips; 13) letters or correspondence; 14) telexes; 15) telegrams; 16) facsimile transmissions; 17) statements; 18) policies; 19) manuals or binders; 20) books; 21) handbooks; 22) business records; 23) personnel records; 24) ledgers; 25) notices; 26) warnings; 27) affidavits; 28) declarations under penalty of perjury; 29) unsworn statements; 30) reports; 31) diaries; or 32) calendars, regardless of whether they are handwritten, printed, typed, mechanically or electronically recorded or reproduced on any medium capable of conveying an image, such as paper, CDs, DVDs, or diskettes.

We agree to pay any and all expenses up to $25.00 related to this request. If you anticipate that the nature or volume of the records requested is such as to require extensive use of information technology, resources, or extensive clerical or supervisory assistance by personnel of the Food and Drug Administration, and such expenses would exceed $25.00, we would appreciate being advised thereof in advance of the assembly of those records and the estimated charge in excess of $25.00 if any, for doing so.

If the FDA asserts an exemption from Public Records Act disclosure of any records falling within the scope of the above request, we request that it include in the records inspected, or otherwise make available to us as soon as possible and in no event no later than the date of the initial production of the records, a reasonable description of the nature of the records for which an exemption or exemptions are claimed and the statutory or other legal bases under any such exemption is claimed.

I would appreciate your contacting me, at ___________ at the earliest possible time to advise us of when the FDA will make the requested copies available.

Please call if you have any questions regarding this request.

Sincerely,

 

Name

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