[Federal Register Volume 67, Number 158 (Thursday, August 15, 2002)]
[Rules and Regulations]
[Pages 53305-53306]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20701]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 5 and 16

[Docket No. 02N-0251]


Presiding Officers at Regulatory Hearings

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
administrative regulations governing who may act as a presiding officer 
at a regulatory hearing. This action amends the regulations to permit 
an administrative law judge (ALJ) to act as a presiding officer and 
provide the appropriate delegations of authority. FDA is taking this 
action to increase the pool of qualified personnel available as 
presiding officers, thereby increasing the efficiency with which the 
agency conducts regulatory hearings, beginning with responding to 
hearing requests and continuing through issuance of written hearing 
reports. Elsewhere in this issue of the Federal Register, FDA is 
publishing a companion proposed rule, under FDA'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: This rule is effective December 30, 2002. Submit written or 
electronic comments on or before October 29, 2002. If FDA receives no 
significant adverse comments within the specified comment period, the 
agency will publish a document confirming the effective date of the 
final rule in the Federal Register within 30 days after the comment 
period on this direct final rule ends. If timely significant adverse 
comments are received, the agency will publish a document in the 
Federal Register withdrawing this direct final rule before its 
effective date.

ADDRESSES: Submit written comments on the direct final rule to the 
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Peter C. Beckerman, Office of the 
Chief Counsel (GCF-1), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-827-7144.

SUPPLEMENTARY INFORMATION:

I. Discussion

    FDA's procedures for a regulatory hearing are set forth in part 16 
(21 CFR part 16) of the agency's regulations. ``Part 16 hearings'' are 
offered under numerous statutory and regulatory provisions. Section 
16.1 provides a list of statutes and regulations in which part 16 
hearings are available.
    Currently Sec. 16.42(a) provides that an FDA employee to whom the 
Commissioner of Food and Drugs (the Commissioner) delegates the 
authority, or any other FDA employee to whom such authority is 
redelegated, can serve as the presiding officer at a regulatory 
hearing. In turn, Sec. 5.30(c) (21 CFR 5.30(c)) delegates authority to 
preside at and conduct a regulatory hearing to the Chief Mediator and 
Ombudsman for the Agency; the Directors and Deputy Directors of the 
Center for Food Safety and Applied Nutrition, the Center for Drug 
Evaluation and Research, the Center for Devices and Radiological 
Health, and the Center for Biologics Evaluation Research; Regional 
Directors; District Directors; the Director of the St. Louis Branch; 
and such other FDA official as the Commissioner may designate by 
memorandum in the proceeding.
    FDA believes that the addition of the ALJ to the list of those 
delegated to conduct regulatory hearings would increase the pool of 
qualified personnel available to preside at regulatory hearings. In 
addition, by virtue of the nature of an ALJ's training and experience 
adjudicating disputes, FDA believes that an ALJ would be appropriately 
suited to conduct regulatory hearings. Therefore, the agency is 
amending Secs. 5.30(c) and 16.42(a) to permit an ALJ to preside at and 
conduct regulatory hearings before the agency.
    The regulations pertaining to ALJs issued by the Office of 
Personnel Management (OPM) (5 CFR 930.209(b)), provide that an agency 
may assign an ALJ, by detail or otherwise, to perform duties that are 
not the duties of an ALJ without prior approval by OPM when the duties 
are not inconsistent with the duties and responsibilities of an ALJ, 
the assignment is not to last longer than 120 days; and the ALJ has not 
had an aggregate of more than 120 days of such assignments or details 
in the preceding year. However, OPM's regulations under 5 CFR 
930.209(c) also state that on a showing that it is in the public 
interest, OPM may authorize a waiver from the 120-day limitation.
    For the reasons already discussed, FDA believes it would be in the 
public interest to permit an ALJ to preside at and conduct part 16 
hearings.

II. Direct Final Rulemaking

    FDA has determined that the subject of this rulemaking is suitable 
for a direct final rule. This direct final rule revises Secs. 5.30(c) 
and 16.42(a) to permit an ALJ to preside at and conduct regulatory 
hearings before the agency. The action taken should be 
noncontroversial, and the agency does not anticipate receiving any 
significant adverse comment on this rule.
    If FDA does not receive significant adverse comment by October 29, 
2002, the agency will publish a document in the Federal Register before 
November 28, 2002, confirming the effective date of the final rule. The 
agency intends to make the direct final rule effective 30 days after 
publication of the confirmation document in the Federal Register. 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 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 also states 
why this rule would be ineffective without the additional change. If 
timely significant adverse comments are received, the agency will 
publish a document in the Federal Register withdrawing this direct 
final rule before November 28, 2002.
    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 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 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. FDA will not provide additional 
opportunity for comment on the companion proposed rule. A full 
description of FDA's policy on direct final rule procedures may be 
found in a guidance document published in the Federal Register of 
November 21, 1997 (62 FR 62466).

[[Page 53306]]

III. Legal Authority

    The broad rulemaking authority conferred on FDA by the U.S. 
Congress under the Federal Food, Drug, and Cosmetic Act (the act) (21 
U.S.C. 201 et seq.) permits the agency to amend its regulations as 
contemplated by this direct final rule. Section 701(a) of the act (21 
U.S.C. 371(a)) gives FDA general rulemaking authority to issue 
regulations for efficient enforcement of the act.

IV. Environmental Impact

    The agency has determined under 21 CFR 25.30(h) 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.

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) (as 
amended by subtitle D of the Small Business Regulatory Fairness Act of 
1996 (Public Law 104-121)), 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 rule is consistent with the 
regulatory philosophy and principles identified in the Executive order 
and in the other two statutes. This rule is not a significant 
regulatory action as defined by the Executive order and so is not 
subject to review under the Executive order.
    Under the Regulatory Flexibility Act, if a rule has a significant 
impact on a substantial number of small entities, an agency must 
analyze regulatory options that would minimize any significant impact 
of the rule on small entities. The agency has considered the effect 
that this rule would have on small entities. Because the rule will 
amend only internal agency procedures, 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 (2 
U.S.C. 1531) requires that agencies prepare a written statement of 
anticipated costs and benefits before issuing any proposed or final 
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 million or more (adjusted annually 
for inflation) in any one year * * *.'' This final rule imposes no 
Federal mandate that will result in such an expenditure. Therefore, FDA 
is not required to prepare a cost/benefit statement.

VI. 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 order and, consequently, a federalism 
summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    This direct final rule does not require information collection. 
Therefore, clearance by the Office of Management and Budget under the 
Paperwork Reduction Act of 1995 is not required.

VIII. Request for Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written comments regarding this rule. Two copies of any 
comments are to be submitted, except that individuals may submit one 
copy. Comments are to be identified with the docket number found in 
brackets in the heading of this document. Received comments may be seen 
in the Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

List of Subjects

21 CFR Part 5

    Authority delegations (Government agencies), Imports, Organization 
and functions (Government agencies).

21 CFR Part 16

    Administrative practice and procedure.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 
5 and 16 are amended as follows:

PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATIONS

    1. The authority citation for 21 CFR part 5 continues to read as 
follows:

    Authority: 5 U.S.C. 504, 552, App. 2 605; 7 U.S.C. 138a, 2217; 
15 U.S.C. 638, 1261-1282, 1451-1461, 3701-3711a; 21 U.S.C. 61-63, 
141-149, 301-394, 467f, 679(b), 801-886, 1031-1309, 1401-1403; 35 
U.S.C. 156; 42 U.S.C. 238, 241, 242, 242a, 242l, 242n, 242o, 243, 
262, 263, 264, 265, 300u-300u-5, 300aa-1, 300ar-25-28, 300cc, 300ff, 
1395y, 4332, 4831(a), 10007-10008; E.O. 11921, 41 FR 24294, 3 CFR, 
1977 Comp., p. 124-131; E.O. 12591, 52 FR 13414, 3 CFR, 1988 Comp., 
p. 220-223.
    2. In Sec. 5.28 revise paragraph (c)(1), redesignate paragraph 
(c)(10) as paragraph (c)(11), and add new paragraph (c)(10) to read as 
follows:


Sec. 5.28  Hearings.

* * * * *
    (c) * * * 
    (1) The Director, Office of the Ombudsman, Office of External 
Relations, Office of the Commissioner.
* * * * *
    (10) An Administrative Law Judge.
* * * * *

PART 16--REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

    3. The authority citation for 21 CFR part 16 continues to read as 
follows:

    Authority: 15 U.S.C. 1451-1461; 21 U.S.C. 141-149, 321-394, 
467f, 679, 821, 1034; 28 U.S.C. 2112; 42 U.S.C. 201-262, 263b, 364.
    4. Amend Sec.  16.42 by revising paragraph (a) to read as follows:


Sec. 16.42  Presiding officer.

    (a) An FDA employee to whom the Commissioner delegates such 
authority, or any other agency employee designated by an employee to 
whom such authority is delegated, or, consistent with 5 CFR 930.209(b) 
or (c), an administrative law judge to whom such authority is 
delegated, may serve as the presiding officer and conduct a regulatory 
hearing under this part.
* * * * *

    Dated: August 7, 2002.
Margaret M. Dotzel,
Associate Commissioner for Policy.
[FR Doc. 02-20701 Filed 8-14-02; 8:45 am]
BILLING CODE 4160-01-S