[Federal Register Volume 67, Number 158 (Thursday, August 15, 2002)]
[Proposed Rules]
[Pages 53324-53326]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-20700]


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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: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend 
its administrative regulations governing who may act as a presiding 
officer at a regulatory hearing. This action would amend the 
regulations to permit an administrative law judge (ALJ) to act as a 
presiding officer and provide the appropriate delegations of authority. 
It is intended 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. This proposed rule is a companion document to the direct final 
rule published elsewhere in this issue of the Federal Register.

DATES: Submit written or electronic comments on the proposed rule on or 
before October 29, 2002. If FDA receives any significant adverse 
comments, the agency will publish a document withdrawing the direct 
final rule within 30 days after the comment period ends. FDA will then 
proceed to respond to comments under this proposed rule using the usual 
notice-and-comment procedures.

ADDRESSES: Submit written comments 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

    As described in the related direct final rule, 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 Director of the 
Office of the 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 and 
Reasearch; 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 
proposing to amend 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.

[[Page 53325]]

    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. Additional Information

    This proposed rule is a companion to the direct final rule 
published in the final rules section of this issue of the Federal 
Register. This companion proposed rule and the direct final rule are 
identical. This companion proposed rule will provide the procedural 
framework to finalize the rule in the event the direct final rule 
receives significant adverse comments and is withdrawn. The comment 
period for this 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. 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 within 30 days after the comment period ends, and FDA intends 
the direct final rule to become effective 30 days after publication of 
the confirmation document. If FDA receives significant adverse 
comments, the agency will withdraw the direct final rule. FDA will 
proceed to respond to all the comments received regarding the rule, and 
if appropriate, the rule will be finalized under this companion 
proposed rule using usual notice-and-comment procedures.
    For additional information, see the corresponding direct final rule 
published in the final rules section of this issue of the Federal 
Register. FDA will not provide additional opportunity for comment. 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 states why 
this rule would be ineffective without the additional change.

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 proposed 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) 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.

V. Analysis of Impacts

    FDA has examined the impacts of this proposed 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 (2 U.S.C. 1501 et seq.). 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 and in the other two statutes. This 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.
    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 proposed rule would have on small entities. Because the 
proposed rule will amend only internal agency procedures, the agency 
certifies that the proposed 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 proposed 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 proposed rule in accordance with the 
principles set forth in Executive Order 13132. FDA has determined that 
the proposed 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 proposed 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.

VII. Paperwork Reduction Act of 1995

    FDA tentatively concludes that this 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.

VIII. Request for Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this proposal. 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. In the event the direct final rule is withdrawn, 
all comments will be considered comments on this proposed rule.

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:

[[Page 53326]]

PART 5--DELEGATIONS OF AUTHORITY AND ORGANIZATION

    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. 02-20700 Filed 8-14-02; 8:45 am]
BILLING CODE 4160-01-S