[Federal Register Volume 70, Number 139 (Thursday, July 21, 2005)]
[Rules and Regulations]
[Pages 41956-41958]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 05-14320]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 20

[Docket No. 2004N-0214]


Public Information Regulations

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its public 
information regulations to implement more comprehensively the 
exemptions contained in the Freedom of Information Act (FOIA). This 
action incorporates exemptions one, two, and three of the FOIA into 
FDA's public information regulations. Exemption one applies to 
information that is classified in the interest of national defense or 
foreign policy. Exemption two applies to records that are related 
solely to an agency's internal personnel rules and practices. Exemption 
three incorporates the various nondisclosure provisions that are 
contained in other Federal statutes.

DATES: The rule is effective August 22, 2005.

FOR FURTHER INFORMATION CONTACT: Betty B. Dorsey, Division of Freedom 
of Information (HFI-35), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-6567.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA is amending its public information regulations to incorporate 
exemptions one, two, and three of the FOIA (5 U.S.C. 552). The FOIA 
provides that all Federal agency records shall be made available to the 
public upon request, except to the extent those records are protected 
from public disclosure by one of nine exemptions (5 U.S.C. 552(b)) or 
one of three special law enforcement record exclusions (5 U.S.C. 
552(c)). FDA originally issued its public information regulations 
implementing the FOIA in 1974 (39 FR 44602, December 24, 1974). As 
noted at the time, FDA's 1974 regulations explicitly addressed four of 
the nine FOIA exemptions-- those that were then perceived to be of 
particular importance to the agency and those relating to trade 
secrets, internal memoranda, personal privacy, and investigatory files 
(39 FR 44602). FDA now finds it necessary to address exemption one (5 
U.S.C. 552(b)(1)), given the President's designation of the Secretary 
of Health and Human Services to classify information under Executive 
Order 12958 (66 FR 64347, December 12, 2001). Because exemption two (5 
U.S.C. 552(b)(2)) applies to, among other types of records, internal 
matters whose disclosure would risk circumvention of a legal 
requirement, this exemption is of fundamental importance to homeland 
security in light of recent terrorism events and heightened security 
awareness. In addition, FDA now finds that exemption three (5 U.S.C. 
552(b)(3)), which incorporates the various nondisclosure provisions 
that are contained in other Federal statutes, is becoming increasingly 
relevant to the agency.
    In the Federal Register of September 2, 2004, we published a direct 
final rule (69 FR 53615) to revise subpart D of FDA's public 
information regulations in part 20 (21 CFR part 20) to incorporate 
these three exemptions. In the same issue of the Federal Register, we 
published a companion proposed rule (69 FR 53662) to provide a 
procedural framework in which the rule could be finalized in the event 
we received any significant adverse comments regarding the direct final 
rule. We withdrew the direct final rule.
    We received significant adverse comment on the direct final rule. 
Accordingly, we published a document in the Federal Register of January 
18, 2005 (70 FR 2799), withdrawing the direct final rule. We applied 
the comments regarding the withdrawn direct final rule to the companion 
proposed rule and considered them in developing this final rule.
    In addition to the changes in the proposed rule, this document also 
clarifies and updates Sec.  20.82(b)(3). While this regulation had 
previously listed specific statutory provisions that prohibit public 
disclosure, this list was incomplete (e.g., it did not reference the 
Ethics in Government Act (5 U.S.C. app. 107(a)(2))) and was out-of-date 
(e.g, it listed 42 U.S.C. 263i, which is now codified at 21 U.S.C. 
360nn). The amendment replaces this list of statutory provisions with a 
statement that FDA will not make available for public disclosure 
information that is prohibited from public disclosure under statute.

II. Comments on the Proposed Rule

    This section discusses the two comments we received.
    Issue 1: One comment suggested adding a statement that a request 
for records should not be denied without good cause.
    Our Response: FDA is not adopting this comment because it is not 
necessary. Under the FOIA, an agency may not withhold a record or a 
portion of a record unless it falls within an FOIA exemption or 
exclusion. These exemptions and exclusions, including the three 
exemptions in the proposed rule, reflect the balance under the FOIA 
between providing the public with access to Government documents and 
the need of the Government to keep information in confidence. See, for 
example, John Doe Agency v. John Doe Corp., 493 U.S. 146, 152-53 
(1989)). Thus, if a record or portion of a record falls within an FOIA 
exemption, this in and of itself indicates that the Government has good 
cause for withholding it. Even when an exemption applies, however, 
FDA's regulations state that the agency will nonetheless make the 
fullest possible disclosure of records to the public, consistent with 
the rights of individuals to privacy, the interests of persons in trade 
secrets and confidential commercial or financial information, and the 
need for the agency to promote frank internal policy deliberations and 
to pursue its regulatory activities without disruption (Sec. Sec.  
20.20(a) and 20.82(a)).
    Issue 2: The second comment stated that the proposed amendments to 
FDA's public information regulations were unnecessarily restrictive. It 
went on to suggest several changes to them. Regarding proposed Sec.  
20.65 (the

[[Page 41957]]

exemption relating to national defense and foreign policy materials), 
the comment suggested that the scope of FDA's implementing regulation 
not include material relating to foreign policy, on the basis that 
public health issues should trump any foreign policy concerns. It also 
recommended adding the following several qualifications to the proposed 
regulation: (1) Any withholding must not directly conflict with any 
statute or judicial mandate, (2) the Executive order under which the 
records are classified must be constitutionally valid, and (3) the 
Executive order must specifically address activities of the Department 
of Health and Human Services (HHS).
    Our Response: FDA is not adopting these comments. FDA's 
implementation of this exemption is consistent with exemption one of 
the FOIA, essentially tracking that language verbatim. It is likewise 
consistent with HHS' exemption one regulation (45 CFR 5.62) and the 
exemption one regulations issued by other agencies. FDA does not 
believe there is a valid need for its implementation of exemption one 
of the FOIA to be substantially different from exemption one of the 
FOIA or for its implementation to be substantially different from other 
agencies' implementation of the exemption. Therefore, FDA does not 
agree that the suggested changes are warranted.
    Issue 3: Regarding proposed Sec.  20.66 (the exemption for internal 
personnel rules and practices), the second comment suggested not 
withholding such materials from a person who is or was subject to such 
personnel rules and practices. The comment also suggested deleting the 
statement in the proposed regulation that the agency may withhold 
internal records whose release would help some persons circumvent the 
law, asserting that this language is so vague it would apply to all FDA 
information.
    Our Response: As with all of the exemptions in FDA's public 
information regulations, this exemption would not apply to sharing 
information with current FDA employees. Therefore, a statement about 
employee access to FDA's internal personnel rules and practices would 
be unnecessary. FDA has routinely distributed this type of information 
to its employees through a variety of mechanisms and will continue to 
do so. Likewise, adding such a statement to the exemption might be 
confusing because it could imply that the exemptions listed in part 20 
apply to sharing information with FDA employees. Regarding former 
employees, whether or not a particular FOIA exemption applies to a 
record does not depend on the identity of the person requesting the 
record or the nature of the person's interest in the record. See, for 
example, United States Dep't of Justice v. Reporters Comm. for Freedom 
of the Press, 489 U.S. 749, 771 (1989). Former employees, therefore, 
have the same access to information under the FOIA as any other member 
of the public.
    FDA does not agree that it should delete the statement about 
withholding material that would help some persons circumvent the law. 
This statement is consistent with exemption two of the FOIA. For 
example, in describing this exemption, the D.C. Court of Appeals stated 
that ``predominantly internal documents the disclosure of which would 
risk circumvention of agency statutes and regulations are protected by 
the so-called `high 2' exemption.'' (Schiller v. NLRB, 964 F.2d 1205, 
1207 (D.C. Cir. 1992)). The statement is also consistent with the HHS' 
exemption two regulation (45 CFR 5.63). For these reasons, FDA is not 
adopting these comments.
    Issue 4: Proposed Sec.  20.67 stated that:
    Records or information may be withheld from public disclosure if a 
statute specifically allows the Food and Drug Administration (FDA) to 
withhold them. FDA may use another statute to justify withholding 
records and information only if it absolutely prohibits disclosure, 
sets forth criteria to guide our decision on releasing material, or 
identifies particular types of matters to be withheld.
    The second comment suggested having this exemption apply only if 
the statute specifically requires FDA to withhold the records and only 
if the statute absolutely prohibits disclosure.
    Our Response: FDA is not adopting this comment. FDA believes it is 
appropriate to consider withholding material from public release when a 
statute identifies particular types of information to be withheld and 
when a statute sets forth criteria to guide FDA's decision on releasing 
and withholding material, regardless of whether the statute 
specifically requires FDA to withhold the material. FDA's 
implementation of this exemption is consistent with FOIA exemption 
three, HHS' exemption three regulation (45 CFR 5.64), and other 
agencies' exemption three regulations.

III. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) and (i) that this 
action is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

IV. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and 
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive 
Order 12866 directs agencies to assess all costs and benefits of 
available regulatory alternatives and, when regulation is necessary, to 
select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this final rule is consistent with the regulatory philosophy and 
principles identified in the Executive order. In addition, the final 
rule is not a significant regulatory action as defined by the Executive 
order and so is not subject to review under the Executive order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because this final rule simply incorporates three 
existing FOIA exemptions, the agency certifies that the final rule will 
not have a significant economic impact on a substantial number of small 
entities. Therefore, under the Regulatory Flexibility Act, no further 
analysis is required.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation)

[[Page 41958]]

in any one year.'' The current threshold after adjustment for inflation 
is $115 million, using the most current (2003) Implicit Price Deflator 
for the Gross Domestic Product. FDA does not expect this final rule to 
result in any 1-year expenditure that would meet or exceed this amount.

VI. Paperwork Reduction Act of 1995

    The final rule contains no collections of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

List of Subjects in 21 CFR Part 20

    Confidential business information, Courts, Freedom of information, 
Government employees.

0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
20 is amended as follows:

PART 20--PUBLIC INFORMATION

0
1. The authority citation for part 20 continues to read as follows:

    Authority: 5 U.S.C. 552; 18 U.S.C. 1905; 19 U.S.C. 2531-2582; 21 
U.S.C. 321-393, 1401-1403; 42 U.S.C. 241, 242, 242a, 242l, 242n, 
243, 262, 263, 263b-263n, 264, 265, 300u-300u-5, 300aa-1.

0
2. Section 20.65 is added to read as follows:


Sec.  20.65  National defense and foreign policy.

    (a) Records or information may be withheld from public disclosure 
if they are:
    (1) Specifically authorized under criteria established by an 
Executive order to be kept secret in the interest of national defense 
or foreign policy; and
    (2) In fact properly classified under such Executive order.
    (b) [Reserved]

0
3. Section 20.66 is added to read as follows:


Sec.  20.66  Internal personnel rules and practices.

    Records or information may be withheld from public disclosure if 
they are related solely to the internal personnel rules and practices 
of the Food and Drug Administration (FDA). Under this exemption, FDA 
may withhold records or information about routine internal agency 
practices and procedures. Under this exemption, the agency may also 
withhold internal records whose release would help some persons 
circumvent the law.

0
4. Section 20.67 is added to read as follows:


Sec.  20.67  Records exempted by other statutes.

    Records or information may be withheld from public disclosure if a 
statute specifically allows the Food and Drug Administration (FDA) to 
withhold them. FDA may use another statute to justify withholding 
records and information only if it absolutely prohibits disclosure, 
sets forth criteria to guide our decision on releasing material, or 
identifies particular types of matters to be withheld.

0
5. Section 20.82 is amended by revising paragraph (b)(3) to read as 
follows:


Sec.  20.82  Discretionary disclosure by the Commissioner.

* * * * *
    (b) * * *
    (3) Prohibited from public disclosure under statute.
* * * * *

    Dated: July 13, 2005.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 05-14320 Filed 7-20-05; 8:45 am]
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