NICOPURE v. FDA: JOINT MOTION FOR ENTRY OF PROTECTIVE ORDER, Jun 6, 2016

June 7, 2016 4:05 pm by Gene Borio

The PDF is Here

EXCERPT:

3. The administrative record contains over 135,000 comments. FDA estimates that more than 10,000 of those are web-based comments from individual consumers, many of which contain personally identifying information, such as names and e-mail addresses, in the “submitter information” field. Although this identifying information is not disclosed online, it appears in the administrative record and cannot be redacted without a page-by-page review of all 135,000 comments. In addition, at least one commenter specifically designated its comment as confidential.

4. This information is private in nature, may be confidential, and may be protected from disclosure under the Privacy Act absent a court order. The entry of an order addressing the disclosure, handling, and use of this information would facilitate the production of the administrative record and promote an efficient resolution of this action.

5. Accordingly, the parties jointly request that the Court enter the attached Protective Order.

END EXCERPT

FULL TEXT:

Case 1:16-cv-00878-ABJ Document 12 Filed 06/06/16 Page 1 of 2

IN THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF COLUMBIA

NICOPURE LABS, LLC,

Plaintiff,

v.

FOOD AND DRUG ADMINISTRATION, et al.,

Defendants.

Civil Action No. 16-878 (ABJ)

JOINT MOTION FOR ENTRY OF PROTECTIVE ORDER

The parties respectfully move the Court to enter the attached Protective Order pursuant to 5 U.S.C. § 552a(b)(11) and Federal Rule of Civil Procedure 26(c). In support of this motion, the parties state as follows:

1. In this case, Plaintiff challenges a Food and Drug Administration (“FDA”) rule that deems electronic cigarettes and “vaping” devices, among other products, to be “tobacco products” subject to FDA regulation. See FDA, Deeming Tobacco Products to Be Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act; Restrictions on the Sale and Distribution of Tobacco Products and Required Warning Statements for Tobacco Products, No. FDA-2014-N-0189, 81 Fed. Reg. 28,973 (May 10, 2016).

2. Defendants intend to produce the administrative record to Plaintiff, and to file a certified list of its contents, by June 7, 2016. See LCvR 7(n).

3. The administrative record contains over 135,000 comments. FDA estimates that more than 10,000 of those are web-based comments from individual consumers, many of which contain personally identifying information, such as names and e-mail addresses, in the “submitter information” field. Although this identifying information is not disclosed online, it appears in the

Case 1:16-cv-00878-ABJ Document 12 Filed 06/06/16 Page 2 of 2

administrative record and cannot be redacted without a page-by-page review of all 135,000 comments. In addition, at least one commenter specifically designated its comment as confidential.

4. This information is private in nature, may be confidential, and may be protected from disclosure under the Privacy Act absent a court order. See 5 U.S.C. § 552a(b)(11). The entry of an order addressing the disclosure, handling, and use of this information would facilitate the production of the administrative record and promote an efficient resolution of this action.

5. Accordingly, the parties jointly request that the Court enter the attached Protective Order.

Dated: June 6, 2016 Respectfully submitted,

/s/ Benjamin Block BENJAMIN C. MIZER

Benjamin C. Block (Bar No. 479705) Principal Deputy Assistant Attorney General

Kevin King (Bar No. 1012403)

COVINGTON & BURLING LLP JOSHUA E. GARDNER

OneCityCenter Assistant Director850 Tenth Street NW

Washington, DC 20001-4956 /s/ Eric Beckenhauer

(202) 662-6000 ERIC B. BECKENHAUER

(202) 662-6291 (fax) Trial Attorney

bblock@cov.com U.S. Department of Justice

kking@cov.com Civil Division, Federal Programs Branch

20 Massachusetts Ave. NW

Attorneys for Plaintiff Washington, DC 20530

Tel: (202) 514-3338

Fax: (202) 616-8470

E-mail: Eric.Beckenhauer@usdoj.go…

Counsel for Defendants

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