[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