[Federal Register Volume 60, Number 248 (Wednesday, December 27, 1995)]
[Notices]
[Pages 66981-66982]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-31368]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95N-253S]


Procedures for Handling Confidential Information in Rulemaking

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is publishing a 
statement regarding the procedures generally followed by the agency 
with respect to the use of confidential commercial information, trade 
secrets, and other confidential or sensitive information during 
rulemaking. In brief, FDA does not place into a public docket trade 
secret, confidential commercial information, or information whose 
disclosure would constitute a clearly unwarranted invasion of privacy 
or would reveal the identity of confidential sources. FDA tries to 
assure that clearly proprietary information is not unwittingly made 
available to the public, but also advises that information submitted to 
a public docket during a rulemaking proceeding does not carry a 
reasonable expectation of confidentiality.

FOR FURTHER INFORMATION CONTACT: Philip L. Chao, Office of Policy (HF-
23), Food and Drug Administration,  5600 Fishers Lane, Rockville, MD 
20857, 301-827-3380.

SUPPLEMENTARY INFORMATION: FDA has received several inquiries regarding 
certain information that FDA used in developing the proposed rule and 
notice pertaining to nicotine-containing cigarettes and smokeless 
tobacco products. The proposed rule, entitled ``Regulations Restricting 
the Sale and Distribution of Cigarettes and Smokeless Tobacco Products 
to Protect Children and Adolescents,'' and an accompanying document 
entitled ``Nicotine in Cigarettes and Smokeless Tobacco Products is a 
Drug and These Products are Nicotine Delivery Devices Under the Federal 
Food, Drug, and Cosmetic Act,'' appeared in the Federal Register on 
August 11, 1995 (60 FR 41314 and 60 FR 41453 at 41454, respectively). 
In general, the cigarette and smokeless tobacco companies have 
questioned or sought to limit FDA's ability to use or to receive 
certain information, particularly documents that were prepared by 
industry officials but not submitted by the industry to FDA during 
rulemaking.
    In response, the agency has developed a statement describing the 
procedures generally followed by the agency with respect to 
confidential information in a rulemaking docket. In brief, FDA does not 
place trade secret, confidential commercial information, or information 
whose disclosure would constitute a clearly unwarranted invasion of 
privacy or would reveal the identity of confidential sources, into a 
public docket. FDA tries to assure that clearly proprietary information 
is not unwittingly made available to the public, but also advises that 
information submitted to a public docket during a rulemaking proceeding 
does not carry a reasonable expectation of confidentiality.
    Although the agency has developed this written statement to address 
concerns raised in the tobacco proceedings, the positions expressed in 
the statement reflect docket management procedures that the agency has 
long used in other rulemaking proceedings. Consequently, FDA is 
publishing the statement in the Federal Register.
    The statement is as follows:

Statement of Procedures for Handling Confidential Information in 
Rulemaking

    FDA has received several inquiries regarding the agency's 
procedures for handling confidential information in the dockets 
compiled for the agency's proposed regulation restricting the sale 
and distribution of cigarettes and smokeless tobacco products to 
protect children and adolescents, and the accompanying legal 
analysis and factual findings, both of which were published in the 
Federal Register on August 11, 1995. This notice describes the 
procedures followed by FDA generally with respect to confidential 
information in a rulemaking docket.
    FDA compiled the docket for the proposed regulation restricting 
the sale and distribution of cigarettes and smokeless tobacco 
products to protect children and adolescents (the proposed rule) and 
the document entitled ``Nicotine in Cigarettes and Smokeless Tobacco 
Products is a Drug and These Products are Nicotine Delivery Devices 
Under the Federal Food, Drug, and Cosmetic Act'' (the document) in 
accordance with the requirements of the Administrative Procedure 
Act, 5 U.S.C. 551, et seq. (APA), and FDA's existing regulations at 
21 CFR 10.40. This docket includes existing factual information and 
submitted information relied upon by the agency decisionmakers in 
support of the analysis and the proposed rule. The agency has also 
included in the docket factual material and submitted information 
considered by agency decisionmakers, except for the limited group of 
documents discussed below.

[[Page 66982]]

    FDA did not place in the public docket trade secret and 
confidential commercial information, or information the disclosure 
of which would constitute a clearly unwarranted invasion of personal 
privacy. An index listing these documents was created by the agency 
and is available to the public. However, unless the information in 
these documents was inextricably intertwined with the other 
information contained in the document, FDA redacted the trade 
secret, confidential commercial, or privacy information and placed 
the remainder of the document in the public docket.
    In addition, FDA did not include in the public docket certain 
documents developed during the course of the agency's investigation 
of the tobacco industry because these documents could disclose the 
identity of sources that furnished information to the agency on a 
confidential basis. The agency's policy with respect to confidential 
sources in this investigation was discussed at the hearings before 
the House Subcommittee on Health and the Environment (see Regulation 
of Tobacco Products (Part 1) (March 25, 1994), pp. 35-37; Regulation 
of Tobacco Products (Part 3) (June 21, 1994), pp. 87-96).
    In the agency's view, there can be no reasonable expectation of 
confidentiality for information submitted to a public docket in a 
rulemaking proceeding. Therefore, an agency is under no legal 
obligation to scrutinize documents submitted to a public docket to 
determine whether they may contain proprietary information. However, 
because it is aware of the sensitivity and importance of such 
information, FDA has long followed certain procedures to try to 
ensure that clearly proprietary information is not unwittingly made 
available to the public. FDA scans documents submitted to a docket 
for obvious trade secrets (e.g., formulas) or personal privacy 
information. In addition, any document marked confidential is 
referred to the appropriate Center Freedom of Information Act 
officer for a determination as to whether it would be exempt from 
public disclosure under Exemption 4 of the Freedom of Information 
Act (trade secrets and commercial or financial information obtained 
from a person and privileged or confidential). Before documents 
containing such information are placed on the record, the Center 
consults with the submitter to determine whether the submitter 
intended to make the document publicly available by placing it on 
the record. The agency is following these procedures in the tobacco 
proceeding.


    Dated: December 21, 1995.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 95-31368 Filed 12-22-95; 11:18 am]
BILLING CODE 4160-01-F