Administrative Practices and Procedures; Internal Review of Agency Decisions

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.

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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.

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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]

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