Administrative Practices and Procedures; Internal Agency Review of Decisions; Companion Document to Direct Final Rule

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will be withdrawn, and the comments will be considered in the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

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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

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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]

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