[Federal Register Volume 63, Number 115 (Tuesday, June 16, 1998)]
[Rules and Regulations]
[Pages 32733-32735]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15815]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 10

[Docket No. 98N-0361]


Administrative Practices and Procedures; Internal Review of 
Agency Decisions

AGENCY: Food and Drug Administration, HHS.

ACTION: Direct final rule.

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SUMMARY: The Food and Drug Administration (FDA) is amending its 
regulations governing the review of agency decisions by inserting a 
statement that sponsors, applicants, or manufacturers of drugs 
(including biologics) or devices may request review of a scientific 
controversy by an appropriate scientific advisory panel, or an advisory 
committee. This action is being taken to clarify the availability of 
review of scientific controversies by such advisory panels and 
committees.

[[Page 32734]]

 Elsewhere in this issue of the Federal Register, FDA is publishing a 
companion proposed rule. If any significant adverse comment is 
received, FDA will withdraw the direct final rule and will follow its 
usual procedures for notice-and-comment rulemaking based on the 
companion proposed rule.

DATES: The regulation is effective October 29, 1998. Submit written 
comments by August 31, 1998. If a timely significant adverse comment is 
received, FDA will publish a document of significant adverse comment in 
the Federal Register by September 29, 1998. If no timely significant 
adverse comment is received, FDA will publish a document in the Federal 
Register by September 29, 1998, to confirm the effective date of 
October 29, 1998.

ADDRESSES: Submit written comments to the Dockets Management Branch 
(HFA-305), Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, 
Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT: Suzanne M. O'Shea, Office of the Chief 
Mediator and Ombudsman (HF-7), Food and Drug Administration, 5600 
Fishers Lane, Rockville, MD 20857, 301-827-3390.

SUPPLEMENTARY INFORMATION:

I. Discussion

    On November 21, 1997, President Clinton signed into law the Food 
and Drug Administration Modernization Act of 1997 (FDAMA) (Pub. L. 105-
115). Section 404 of FDAMA amends the Federal Food, Drug, and Cosmetic 
Act (the act) (21 U.S.C. 301 et seq.) by adding a new provision, 
Dispute Resolution (section 562 of the act (21 U.S.C. 360bbb-1)). Under 
the dispute resolution provision, FDA is to determine the existence of 
procedures for sponsors, applicants, and manufacturers of drugs 
(including biologics) or devices to request review of scientific 
controversies. Where such procedures do not exist, FDA is directed to 
issue a regulation establishing a procedure by which a sponsor, 
applicant, or manufacturer of a drug or device may request review of a 
scientific controversy, including review by an appropriate scientific 
advisory panel as described in section 505(n) of the act\1\ (21 U.S.C. 
355(n)), or an advisory committee as described in section 515(g)(2)(B) 
of the act (21 U.S.C. 360e(g)(2)(B)).
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    \1\ FDA understands the term ``scientific advisory panel'' to 
mean a public advisory committee as discussed in 21 CFR part 14.
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    FDA procedures currently provide mechanisms for sponsors, 
applicants, or manufacturers of drugs and devices to request review of 
all scientific controversies. Agency regulations and policy statements 
contain numerous procedures for obtaining review of scientific 
controversies affecting regulated products, including some that provide 
for review by an FDA advisory panel or committee. Moreover, any 
interested person\2\ may obtain review of any agency decision by 
raising the matter with the supervisor of the employee who made the 
decision. If the issue is not resolved at the supervisor's level, the 
interested person may request that the matter be reviewed at the next 
higher supervisory level. This process may continue through the 
agency's chain of command (Sec. 10.75 (21 CFR 10.75)).
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    \2\ An interested person, as defined in 21 CFR 10.3, is a person 
who submits a petition or comment or objection or otherwise asks to 
participate in an informal or formal administrative proceeding or 
court action. This definition of interested person includes a 
sponsor, applicant, or manufacturer of a drug or device.
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    Notwithstanding the existence of these dispute resolution 
provisions, FDA is amending Sec. 10.75 in light of FDAMA, to clarify 
that sponsors, applicants, or manufacturers of a drug or device subject 
to the act, or a product covered by the Public Health Service Act (42 
U.S.C. 262), may request review of scientific controversies by an 
appropriate scientific advisory committee. FDA recommends that 
sponsors, applicants, and manufacturers continue to use established 
mechanisms for obtaining review of scientific controversies prior to 
seeking review by an advisory panel or committee. FDA recognizes 
however, that in appropriate circumstances, review by such an advisory 
committee may provide FDA with useful advice and recommendations about 
how the agency may best resolve a controversy.

II. Rulemaking Procedures

    FDA described its procedures for direct final rulemaking in the 
Federal Register of November 21, 1997 (62 FR 62466). This action is 
appropriate for direct final rulemaking because it is a 
noncontroversial amendment to FDA's regulations that is in accord with 
FDAMA. Furthermore, FDA anticipates no significant adverse comments. 
Consistent with FDA's procedures for direct final rulemaking, FDA will 
withdraw this direct final rule if it receives any significant adverse 
comment. If this direct final rule is withdrawn, FDA will consider all 
comments received to develop a final rule using the usual notice and 
comment rulemaking procedures, based on the companion proposed rule 
published in the proposed rules section of this issue of the Federal 
Register.
    FDA is providing a period of 75 days for comment on this direct 
final rule, to run concurrently with the comment period for the 
companion proposed rule. This comment period begins on June 16, 1998, 
and ends on August 31, 1998. If FDA receives a significant adverse 
comment, the agency will publish a document of significant adverse 
comment in the Federal Register to withdraw the direct final rule by 
September 29, 1998. If FDA receives no significant adverse comment 
during the comment period, it will publish a document in the Federal 
Register by September 29, 1998, to confirm the October 29, 1998, 
effective date of this direct final rule.
    A significant adverse comment is defined as a comment 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. In determining whether a significant adverse comment 
is sufficient to terminate a direct final rulemaking, FDA will consider 
whether the comment raises an issue serious enough to warrant a 
substantive response in a notice-and-comment process. Comments that are 
frivolous, insubstantial, or outside the scope of the rule will not be 
considered significant or adverse under this procedure. For example, a 
comment requesting inclusion of consumer representatives on an FDA 
advisory committee will not be considered a significant adverse comment 
because it is outside the scope of this rule. A comment suggesting a 
change in addition to that proposed by the rule would not be considered 
a significant adverse comment, unless, as explained by the comment, the 
rule would be ineffective without change.

III. Analysis of Impacts

A. 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.

B. Economic Impact

    In accordance with Executive Order 12866, FDA has carefully 
analyzed the economic effect of this rule and has determined that it is 
not a major rule as defined by the Executive Order.

[[Page 32735]]

    FDA, in accordance with the Regulatory Flexibility Act, has 
considered the effect that this rule will have on small entities, 
including small businesses, and has determined that no significant 
economic impact on a substantial number of small entities will derive 
from this action.

IV. 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.

V. Request for Comments

    Interested persons may, on or before August 31, 1998, submit to the 
Dockets Management Branch (address above) 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 office above between 9 a.m. and 4 
p.m., Monday through Friday. 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 considered 
as comments regarding this direct final rule. Likewise, any comment 
submitted under the direct final rule will be considered as comments to 
the companion proposed rule in the event the direct final rule is 
withdrawn.

List of Subjects in 21 CFR Part 10

    Administrative practice and procedure, News media.
    Therefore, under the Federal Food, Drug, and Cosmetic Act, the 
Public Health Service Act, and authority delegated to the Commissioner 
of Food and Drugs, 21 CFR part 10 is amended as follows:

PART 10--ADMINISTRATIVE PRACTICES AND PROCEDURES

    1. The authority citation for 21 CFR part 10 is revised to read as 
follows:

    Authority: 5 U.S.C. 551-558, 701-706; 15 U.S.C. 1451-4161; 21 
U.S.C. 141-149, 321-397, 467f, 679, 821, 1034; 28 U.S.C. 2112; 42 
U.S.C. 201, 262, 263b, 264.

    2. Section 10.75 is amended by adding a sentence at the end of 
paragraph (b) to read as follows:


Sec. 10.75  Internal agency review of decisions.

* * * * *
    (b) * * * A sponsor, applicant, or manufacturer of a drug or device 
regulated under the act or the Public Health Service Act (42 U.S.C. 
262), may request review of a scientific controversy by an appropriate 
scientific advisory panel as described in section 505(n) of the act, or 
an advisory committee as described in section 515(g)(2)(B) of the act.
* * * * *

    Dated: June 4, 1998.
William K. Hubbard,
Associate Commissioner for Policy Coordination.
[FR Doc. 98-15815 Filed 6-15-98; 8:45 am]
BILLING CODE 4160-01-F