[Federal Register: September 2, 2004 (Volume 69, Number 170)]
[Proposed Rules]               
[Page 53662-53664]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr02se04-23]                         

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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; Companion Document to Direct 
Final Rule

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
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. This proposed rule is a companion to the direct 
final final rule published elsewhere in this issue of the Federal 
Register.

DATES: Submit written or electronic comments by November 16, 2004.

ADDRESSES: You may submit comments, identified by [Docket No. 2004N-
0214], by any of the following methods:
    Federal eRulemaking Portal: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. Follow the 

instructions for submitting comments.
    Agency Web site: http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments. Follow the 

instructions for submitting comments on the agency Web site.
    E-mail: fdadockets@oc.fda.gov. 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

[[Page 53663]]

Docket No. 2004N-0214 for this rulemaking. All comments received will 
be posted without change to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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

    This proposed rule is a companion to the direct final rule 
published in the final rules section of this issue of the Federal 
Register. The companion proposed rule and the direct final rule are 
substantively identical. This companion proposed rule will provide the 
procedural framework to finalize the rule in the event the direct final 
rule receives significant adverse comment and is withdrawn. The comment 
period for the companion proposed rule runs concurrently with the 
comment period of the direct final rule. Any comments received under 
the companion proposed rule will be treated as comments regarding the 
direct final rule. FDA is publishing the direct final rule because the 
rule contains noncontroversial changes, and the agency anticipates that 
it will receive no significant adverse comments. A detailed discussion 
of this rule is set forth in the preamble of the direct final rule. If 
no significant adverse comment is received in response to the direct 
final rule, no further action will be taken related to this proposed 
rule. Instead, FDA will publish a confirmation document before the date 
of the direct final rule, to confirm the effetive date of the direct 
final rule. If FDA receives significant adverse comments, the agency 
will withdraw the direct final rule. FDA will proceed to consider all 
of the comments received using the usual notice-and-comment procedures.
    FDA is proposing to amend its public information regulations to 
incorporate exemptions one, two, and three of 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 proposing to amend subpart D of its public information 
regulations in 21 CFR part 20 to incorporate these three exemptions.

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 proposed 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 proposed 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 proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive order. In addition, the proposed 
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 proposed 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 proposed rule would not have an effect of this magnitude on 
the economy.

VI. Paperwork Reduction Act of 1995

    The proposed 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

[[Page 53664]]

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

PART 20--PUBLIC INFORMATION

    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.
    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]
    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.
    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. 04-19995 Filed 9-1-04; 8:45 am]

BILLING CODE 4160-01-S