[Federal Register Volume 63, Number 115 (Tuesday, June 16, 1998)]
[Proposed Rules]
[Pages 32772-32774]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-15814]


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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 Agency Review 
of Decisions; 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 
the 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. The agency is taking this action to clarify the availability 
of review of scientific controversies by such advisory panels or 
committees. This proposed rule is a companion document to a direct 
final rule published elsewhere in this issue of the Federal Register. 
If FDA receives any significant adverse comment, the direct final rule 
will be withdrawn, and the comments will be considered in the 
development of a final rule using usual notice and comment rulemaking 
based on this proposed rule.

DATES: Comments must be received on or before August 31, 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

[[Page 32773]]

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 
mechanisms, FDA intends to amend 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. If this rule is adopted, 
FDA would recommend that sponsors, applicants, and manufacturers 
continue to use established mechanisms for obtaining review of 
scientific controversies prior to seeking review by an advisory 
committee. FDA recognizes however, that in appropriate circumstances, 
review by such an advisory panel or committee may provide FDA with 
useful advice and recommendations about how the agency may best resolve 
a controversy.

II. Rulemaking Procedures

    In the final rules section of this issue of the Federal Register, 
FDA is announcing the adoption of this amendment through direct final 
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 the direct final rule if it receives any significant adverse 
comment. If the 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 this proposed rule.
    FDA is providing a 75-day period for comment on this companion 
proposed rule, to run concurrently with the comment period for the 
direct final rule. This comment period begins on June 16, 1998, and 
ends on August 31, 1998. If FDA receives any significant adverse 
comment within the comment period, it intends to publish a document in 
the Federal Register to withdraw the direct final rule by September 29, 
1998. If the direct final rule is withdrawn, FDA will follow its usual 
procedures for notice-and-comment rulemaking based on this proposed 
rule. If FDA does not receive any significant adverse comment, the 
agency will take no further action on this proposed rule. In that 
event, FDA will publish a document in the Federal Register by September 
29, 1998, to confirm the October 29, 1998, effective date of the direct 
final rule. For additional information, see the direct final rule 
published in the final rules section of this issue of the Federal 
Register.

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 effects of this rule and has determined that it 
is not a major rule as defined by the Executive Order.
    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

    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.

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 companion proposed rule, which will also be considered as comments 
on the direct final 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.

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, it is proposed that 21 CFR part 10 be 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

[[Page 32774]]

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. 98-15814 Filed 6-15-98; 8:45 am]
BILLING CODE 4160-01-F