ML19085A028
| ML19085A028 | |
| Person / Time | |
|---|---|
| Issue date: | 03/21/2019 |
| From: | Stephanie Blaney Information Services Branch |
| To: | Hom D Nelson, Mullins, Riley & Scarborough, LLP |
| References | |
| FOIA, NRC-2018-000555 | |
| Download: ML19085A028 (2) | |
Text
NRC FORM 464 Part I U.S. NUCLEAR REGULATORY COMMISSION NRC RESPONSE NUMBER (04-2018) 1 201s-000555 11 1 REQUESTER:
RESPONSE TO FREEDOM OF INFORMATION ACT (FOIA) REQUEST RESPONSE TYPE D INTERIM I ./ I FINAL DATE: IDennisHom 11 0312112019 DESCRIPTION OF REQUESTED RECORDS: Copies of all registries on the Sealed Source and Device Registry (SSDR) for: 1) Sirtex Wilmington.
LLC (AKA: SIRTeX Medical Limited), Product Name: SIR-Sphere, SSDR # MA-1229-D-101-S, Brachytherapy Product; and 2) Nordion (Canada), Inc., Product Name: SIR-Sphere, SSCR #NR220-D-113-S, Glass Microsphere; and SSDR #NR-00220-D-131-S 0 D D 0 D D D D PART I. --INFORMATION RELEASED The NRC has made some, or all, of the requested records publicly available through one or more of the following means: (1) https://www.nrc.gov; (2) public ADAMS, https://www.nrc.gov/reading-rm/adams.html; (3) microfiche available in the NRC Public Document Room; or FOIA Online, https://foiaonline.regulations.gov/foia/action/public/home.
Agency records subject to the request are enclosed.
Records subject to the request that contain information originated by or of interest to another Federal agency have been referred to that agency (See Part I.D --Comments) for a disclosure determination and direct response to you . .I We are continuing to process your request. See Part I.D -Comments.
AMOUNT $36.30 0 D D PART I.A --FEES You will be billed by NRC for the amount indicated.
You will receive a refund for the amount indicated.*
Fees waived. D D Since the minimum fee threshold was not met, you will not be charged fees. Due to our delayed response, you will not be charged search and/or duplication fees that would otherwise be applicable to your request. PART 1.8--INFORMATION NOT LOCATED OR WITHHELD FROM DISCLOSURE We did not locate any agency records responsive to your request. Note: Agencies may treat three discrete categories of law enforcement and national security records as not subject to the FOIA ("exclusions").
See 5 U.S.C. 552(c). This is a standard notification given to all requesters; it should not be taken to mean that any excluded records do, or do not, exist. We have withheld certain information pursuant to the FOIA exemptions described, and for the reasons stated, in Part II. Because this is an interim response to your request, you may not appeal at this time. We will notify you of your right to appeal any of the responses we have issued in response to your request when we issue our final determination.
- You may appeal this final determination within 90 calen_dar days of the date of this response.
If you submit an appeal by mail, address it to the FOIA Officer, at U.S. Nuclear Regulatory Commission, Mail Stop T-2 F43, Washington, D.C. 20555-0001.
You may submit an appeal by e-mail to FOIA.resource@nrc.gov.
You may fax an appeal to (301) 415-5130.
Or you may submit an appeal through FOIA Online, https://foiaonline.regulations.gov/foia/action/public/home.
Please be sure to include on your submission that it is a "FOIA Appeal." PART 1.C --REFERENCES AND POINTS OF CONTACT . You have the right to seek assistance from the NRC's FOIA Public Liaison by submitting your inquiry at https://www.nrc.gov/reading-rm/
foia/contact-foia.html, or by calling the FOIA Public Liaison at (301) 415-1276.
lfwe have denied your request, you have the right to seek dispute resolution services from the NRC's Public Liaison or the Office of Government Information Services (OGIS). To seek dispute resolution services from OGIS, you may e-mail OGIS at ogis@nara.gov, send a fax to (202) 741-5789, or send a letter to: Office of Government Information Services, National Archives and Records Administration, 8601 Adelphi Road, College Park, MD 20740-6001.
For additional information about OGIS, please visit the OGIS website at https://www archives.gov/ogis.
NRC FORM 464 Part I (04-2018)
U.S. NUCLEAR REGULATORY COMMISSION RESPONSE TO FREEDOM OF INFORMATION ACT (FOIA) REQUEST PART I.D --COMMENTS NRC 1 201s-000555 RESPONSE TYPE RESPONSE NUMBER 11 1 INTERIM I ./ I FINAL The NRC Office of Nuclear Material Safety and Safeguards (NMSS) searched for responsive records to your request. Per NMSS staff, you will need to request responsive records related to SSDR #MA-1229-D-101-S from the State of Massachusetts.
This state is an NRC Agreement State, and agency records on material licenses were transferred to the state. Contact information for obtaining these is available at https://scp.nrc.gov/rulemaking.html#MA.
NMSS staff has released in their entirety the responsive records to the other portion of your request. These two documents will soon be publicly available on the NRC public web site under their ADAMS Accession Numbers (ML 100750655 and
- ML 18065A 119). We have also included copies with this response.
The amount billed is the one half hour of actual review time by NMSS staff. Signature
-Freedom of Information Act Officer or Designee *Stephanie A. Blaney f Digitally signed by Stephanie A. Blaney f' . // 'Date: 2019.03.21 06:25:21 -04'00' I