[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will be withdrawn, and the comments will be considered in the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