[Federal Register Volume 69, Number 170 (Thursday, September 2, 2004)]
[Rules and Regulations]
[Pages 53615-53616]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-19996]


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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: Direct 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 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. Elsewhere in this issue of the Federal 
Register, FDA is publishing a companion proposed rule, under the 
agency's usual procedure for notice-and-comment rulemaking, to provide 
a procedural framework to finalize the rule in the event the agency 
receives any significant adverse comments and withdraws this direct 
final rule.

DATES: The rule is effective January 17, 2005. Submit written or 
electronic comments by November 16, 2004. If FDA receives no 
significant adverse comments by the specified comment period, the 
agency will publish a document in the Federal Register confirming the 
effective date of this direct final rule. If the agency receives any 
significant adverse comments during the specified comment period, FDA 
intends to withdraw this direct final rule before its effective date by 
publication of a document in the Federal Register.

ADDRESSES: You may submit comments, identified by [Docket No. 2004N-
0214], by any of the following methods:
    Federal eRulemaking Portal: http://www.regulations.gov. Follow the 
instructions for submitting comments.
    Agency Web site: http://www.fda.gov/dockets/ecomments. Follow the 
instructions for submitting comments on the agency Web site.
    E-mail: [email protected]. Include [Docket No. 2004N-0214] in 
the subject line of your e-mail message.
    FAX: 301-827-6870.
    Mail/Hand delivery/Courier [For paper, disk, or CD-ROM 
submissions]: Division of Dockets Management, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852.
    Instructions: All submissions received must include the agency name 
and Docket No. 2004N-0214 for this rulemaking. All comments received 
will be posted without change to http://www.fda.gov/dockets/ecomments, 
including any personal information provided. For detailed instructions 
on submitting comments and additional information on the rulemaking 
process, see the ``Comments'' heading of the SUPPLEMENTARY INFORMATION 
section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.fda.gov/dockets/ecomments and/or 
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852.

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). 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 FOIA in 1974. As noted at the time, FDA's 1974 regulations 
explicitly addressed four of the nine FOIA exemptions that were then 
perceived to be of particular importance to the agency, those relating 
to trade secrets, internal memoranda, personal privacy, and 
investigatory files (39 FR 44602, December 24, 1974). 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 important to the agency. As 
such, FDA is amending, by direct final rule, subpart D of its public 
information regulations in 21 CFR part 20 to incorporate these three 
exemptions.

II. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable 
for a direct final rule. This direct final rule amends the agency's 
public information regulations by incorporation of exemptions one, two, 
and three of FOIA, which have become increasingly relevant to FDA and 
its records. Because these exemptions are already contained in FOIA, 
this action should be noncontroversial, and the agency does not 
anticipate receiving any significant adverse comments on this rule.
    If FDA does not receive significant adverse comments during the 
specified comment period, the agency will publish a document in the 
Federal Register confirming the effective date of this direct final 
rule (see DATES). A significant adverse comment is one that explains 
why the rule would be inappropriate, including challenges to the rule's 
underlying premise or approach, or why it would be ineffective or 
unacceptable without a change. A comment recommending a rule change in 
addition to this rule will not be considered a significant adverse 
comment unless the comment states why this rule would be ineffective 
without the additional change. If timely significant adverse comments 
are received, the agency will publish a document of significant adverse 
comment in the Federal Register withdrawing this direct final rule.
    Elsewhere in this issue of the Federal Register, FDA is publishing 
a companion proposed rule, identical to the direct final rule, that 
provides a procedural framework within which the proposed rule may be 
finalized in the event the direct final rule is withdrawn because of 
significant adverse comment. The comment period for the direct final

[[Page 53616]]

rule runs concurrently with that of the companion proposed rule. Any 
comments received under the companion proposed rule will be treated as 
comments regarding the direct final rule. Likewise, significant adverse 
comments submitted to the direct final rule will be considered as 
comments to the companion proposed rule and the agency will consider 
such comments in developing a final rule. FDA will not provide 
additional opportunity for comment on the companion proposed rule.
    If a significant adverse comment applies to an amendment, 
paragraph, or section of this direct final rule and that provision may 
be severed from the remainder of the rule, FDA may adopt as final those 
provisions of the rule that are not the subject of a significant 
adverse comment. A full description of FDA's policy on the direct final 
rule procedures may be found in a guidance document published in the 
Federal Register of November 21, 1997 (62 FR 62466).

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 direct 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 direct 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 direct 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 direct final rule simply incorporates 
three existing FOIA exemptions, the agency certifies that it 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 of the Unfunded Mandates Reform Act of 1995 requires 
that agencies assess anticipated costs and benefits before issuing any 
rule that may result in expenditure in any one year by State, local, or 
tribal governments, in the aggregate, or by the private sector, of $100 
million, adjusted annually for inflation. As noted previously, we find 
that this final rule would not have an effect of this magnitude on the 
economy.

VI. Paperwork Reduction Act of 1995

    The direct 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.

VII. Comments

    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two paper copies of any 
written comments, except that individuals may submit one paper copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document and may be accompanied by a supporting 
memorandum or brief. Received comments may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.

List of Subjects in 21 CFR Part 20

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

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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

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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.

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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]

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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.

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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.

    Dated: August 24, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-19996 Filed 9-1-04; 8:45 am]
BILLING CODE 4160-01-S