[Code of Federal Regulations]

[Title 45, Volume 1]

[Revised as of October 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 45CFR5.65]



[Page 28-29]

 

                        TITLE 45--PUBLIC WELFARE

 

                    SUBTITLE A--DEPARTMENT OF HEALTH

                           AND HUMAN SERVICES

 

PART 5_FREEDOM OF INFORMATION REGULATIONS--Table of Contents

 

             Subpart F_Reasons for Withholding Some Records

 

Sec.  5.65  Exemption four: Trade secrets and confidential commercial or financial information.



    We will withhold trade secrets and commercial or financial 

information that is obtained from a person and is privileged or 

confidential.

    (a) Trade secrets. A trade secret is a secret, commercially valuable 

plan, formula, process, or device that is used for the making, 

preparing, compounding, or processing of trade commodities and that can 

be said to be the end product of either innovation or substantial 

effort. There must be a direct relationship between the trade secret and 

the productive process.

    (b) Commercial or financial information. We will not disclose 

records whose information is ``commercial or financial,'' is obtained 

from a person, and is ``privileged or confidential.''

    (1) Information is ``commercial or financial'' if it relates to 

businesses, commerce, trade, employment, profits, or finances (including 

personal finances). We interpret this category broadly.

    (2) Information is ``obtained from a person'' if HHS or another 

agency has obtained it from someone outside the Federal Government or 

from someone within the Government who has a commercial or financial 

interest in the information. ``Person'' includes an individual, 

partnership, corporation, association, state or foreign government, or 

other organization. Information is not ``obtained from a person'' if it 

is generated by HHS or another federal agency. However, information is 

``obtained from a person'' if it is provided by someone, including but 

not limited to an agency employee, who retains a commercial or financial 

interest in the information.

    (3) Information is ``privileged'' if it would ordinarily be 

protected from disclosure in civil discovery by a recognized evidentiary 

privilege, such as the attorney-client privilege or the work product 

privilege. Information may be privileged for this purpose under a 

privilege belonging to a person outside the government, unless the 

providing of the information to the government rendered the information 

no longer protectable in civil discovery.

    (4) Information is ``confidential'' if it meets one of the following 

tests:

    (i) Disclosure may impair the government's ability to obtain 

necessary information in the future;

    (ii) Disclosure would substantially harm the competitive position of 

the person who submitted the information;

    (iii) Disclosure would impair other government interests, such as 

program effectiveness and compliance; or

    (iv) Disclosure would impair other private interests, such as an 

interest in controlling availability of intrinsically valuable records, 

which are sold in the market by their owner.



The following questions may be relevant in analyzing whether a record 

meets one or more of the above tests: Is the information of a type 

customarily held in strict confidence and not disclosed to the public by 

the person to whom it belongs? What is the general custom or usage with 

respect to such information in the relevant occupation or business? How 

many, and what types of, individuals have access to the information? 

What kind and degree of financial injury can be expected if the 

information is disclosed?

    (c) Designation of certain confidential information. A person who 

submits records to the government may designate part or all of the 

information in such records as exempt from disclosure under Exemption 4 

of the FOIA. The person may make this designation either at the time the 

records are submitted to the government or within a reasonable time 

thereafter. The designation must be in writing. Where a legend is 

required by a request for proposals or request for quotations, pursuant 

to 48 CFR 352.215-12, then that legend is necessary for this purpose. 

Any such designation will expire ten years



[[Page 29]]



after the records were submitted to the government.

    (d) Predisclosure notification. The procedures in this paragraph 

apply to records on which the submitter has designated information as 

provided in paragraph (c) of this section. They also apply to records 

that were submitted to the government where we have substantial reason 

to believe that information in the records could reasonably be 

considered exempt under Exemption 4. Certain exceptions to these 

procedures are stated in paragraph (e) of this section.

    (1) When we receive a request for such records, and we determine 

that we may be required to disclose them, we will make reasonable 

efforts to notify the submitter about these facts. The notice will 

include a copy of the request, and it will inform the submitter about 

the procedures and time limits for submission and consideration of 

objections to disclosure. If we must notify a large number of 

submitters, we may do this by posting or publishing a notice in a place 

where the submitters are reasonably likely to become aware of it.

    (2) The submitter has five working days from receipt of the notice 

to object to disclosure of any part of the records and to state all 

bases for its objections.

    (3) We will give consideration to all bases that have been timely 

stated by the submitter. If we decide to disclose the records, we will 

notify the submitter in writing. This notice will briefly explain why we 

did not sustain its objections. We will include with the notice a copy 

of the records about which the submitter objected, as we propose to 

disclose them. The notice will state that we intend to disclose the 

records five working days after the submitter receives the notice unless 

we are ordered by a United States District Court not to release them.

    (4) When a requester files suit under the FOIA to obtain records 

covered by this paragraph, we will promptly notify the submitter.

    (5) Whenever we send a notice to a submitter under paragraph (d)(1) 

of this section, we will notify the requester that we are giving the 

submitter a notice and an opportunity to object. Whenever we send a 

notice to a submitter under paragraph (d)(3) of this section, we will 

notify the requester of this fact.

    (e) Exceptions to predisclosure notification. The notice 

requirements in paragraph (d) of this section do not apply in the 

following situations:

    (1) We decided not to disclose the records;

    (2) The information has previously been published or made generally 

available;

    (3) Disclosure is required by a regulation, issued after notice and 

opportunity for public comment, that specifies narrow categories of 

records that are to be disclosed under the FOIA, but in this case a 

submitter may still designate records as described in paragraph (c) of 

this section, and in exceptional cases, we may, at our discretion, 

follow the notice procedures in paragraph (d) of this section; or

    (4) The designation appears to be obviously frivolous, but in this 

case we will still give the submitter the written notice required by 

paragraph (d)(3) of this section (although this notice need not explain 

our decision or include a copy of the records), and we will notify the 

requester as described in paragraph (d)(5) of this section.